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• How to Write a Literature Review | Guide, Examples, & Templates

How to Write a Literature Review | Guide, Examples, & Templates

Published on January 2, 2023 by Shona McCombes . Revised on September 11, 2023.

What is a literature review? A literature review is a survey of scholarly sources on a specific topic. It provides an overview of current knowledge, allowing you to identify relevant theories, methods, and gaps in the existing research that you can later apply to your paper, thesis, or dissertation topic .

There are five key steps to writing a literature review:

• Search for relevant literature
• Evaluate sources
• Identify themes, debates, and gaps
• Outline the structure
• Write your literature review

A good literature review doesn’t just summarize sources—it analyzes, synthesizes , and critically evaluates to give a clear picture of the state of knowledge on the subject.

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Table of contents

What is the purpose of a literature review, examples of literature reviews, step 1 – search for relevant literature, step 2 – evaluate and select sources, step 3 – identify themes, debates, and gaps, step 4 – outline your literature review’s structure, step 5 – write your literature review, free lecture slides, other interesting articles, frequently asked questions, introduction.

• Quick Run-through
• Step 1 & 2

When you write a thesis , dissertation , or research paper , you will likely have to conduct a literature review to situate your research within existing knowledge. The literature review gives you a chance to:

• Demonstrate your familiarity with the topic and its scholarly context
• Develop a theoretical framework and methodology for your research
• Position your work in relation to other researchers and theorists
• Show how your research addresses a gap or contributes to a debate
• Evaluate the current state of research and demonstrate your knowledge of the scholarly debates around your topic.

Writing literature reviews is a particularly important skill if you want to apply for graduate school or pursue a career in research. We’ve written a step-by-step guide that you can follow below.

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Writing literature reviews can be quite challenging! A good starting point could be to look at some examples, depending on what kind of literature review you’d like to write.

• Example literature review #1: “Why Do People Migrate? A Review of the Theoretical Literature” ( Theoretical literature review about the development of economic migration theory from the 1950s to today.)
• Example literature review #2: “Literature review as a research methodology: An overview and guidelines” ( Methodological literature review about interdisciplinary knowledge acquisition and production.)
• Example literature review #3: “The Use of Technology in English Language Learning: A Literature Review” ( Thematic literature review about the effects of technology on language acquisition.)
• Example literature review #4: “Learners’ Listening Comprehension Difficulties in English Language Learning: A Literature Review” ( Chronological literature review about how the concept of listening skills has changed over time.)

You can also check out our templates with literature review examples and sample outlines at the links below.

Download Word doc Download Google doc

Before you begin searching for literature, you need a clearly defined topic .

If you are writing the literature review section of a dissertation or research paper, you will search for literature related to your research problem and questions .

Make a list of keywords

Start by creating a list of keywords related to your research question. Include each of the key concepts or variables you’re interested in, and list any synonyms and related terms. You can add to this list as you discover new keywords in the process of your literature search.

• Social media, Facebook, Instagram, Twitter, Snapchat, TikTok
• Body image, self-perception, self-esteem, mental health
• Generation Z, teenagers, adolescents, youth

Search for relevant sources

Use your keywords to begin searching for sources. Some useful databases to search for journals and articles include:

• Your university’s library catalogue
• Google Scholar
• Project Muse (humanities and social sciences)
• Medline (life sciences and biomedicine)
• EconLit (economics)
• Inspec (physics, engineering and computer science)

You can also use boolean operators to help narrow down your search.

Make sure to read the abstract to find out whether an article is relevant to your question. When you find a useful book or article, you can check the bibliography to find other relevant sources.

You likely won’t be able to read absolutely everything that has been written on your topic, so it will be necessary to evaluate which sources are most relevant to your research question.

For each publication, ask yourself:

• What question or problem is the author addressing?
• What are the key concepts and how are they defined?
• What are the key theories, models, and methods?
• Does the research use established frameworks or take an innovative approach?
• What are the results and conclusions of the study?
• How does the publication relate to other literature in the field? Does it confirm, add to, or challenge established knowledge?
• What are the strengths and weaknesses of the research?

Make sure the sources you use are credible , and make sure you read any landmark studies and major theories in your field of research.

You can use our template to summarize and evaluate sources you’re thinking about using. Click on either button below to download.

Take notes and cite your sources

As you read, you should also begin the writing process. Take notes that you can later incorporate into the text of your literature review.

It is important to keep track of your sources with citations to avoid plagiarism . It can be helpful to make an annotated bibliography , where you compile full citation information and write a paragraph of summary and analysis for each source. This helps you remember what you read and saves time later in the process.

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To begin organizing your literature review’s argument and structure, be sure you understand the connections and relationships between the sources you’ve read. Based on your reading and notes, you can look for:

• Trends and patterns (in theory, method or results): do certain approaches become more or less popular over time?
• Themes: what questions or concepts recur across the literature?
• Debates, conflicts and contradictions: where do sources disagree?
• Pivotal publications: are there any influential theories or studies that changed the direction of the field?
• Gaps: what is missing from the literature? Are there weaknesses that need to be addressed?

This step will help you work out the structure of your literature review and (if applicable) show how your own research will contribute to existing knowledge.

• Most research has focused on young women.
• There is an increasing interest in the visual aspects of social media.
• But there is still a lack of robust research on highly visual platforms like Instagram and Snapchat—this is a gap that you could address in your own research.

There are various approaches to organizing the body of a literature review. Depending on the length of your literature review, you can combine several of these strategies (for example, your overall structure might be thematic, but each theme is discussed chronologically).

Chronological

The simplest approach is to trace the development of the topic over time. However, if you choose this strategy, be careful to avoid simply listing and summarizing sources in order.

Try to analyze patterns, turning points and key debates that have shaped the direction of the field. Give your interpretation of how and why certain developments occurred.

If you have found some recurring central themes, you can organize your literature review into subsections that address different aspects of the topic.

For example, if you are reviewing literature about inequalities in migrant health outcomes, key themes might include healthcare policy, language barriers, cultural attitudes, legal status, and economic access.

Methodological

If you draw your sources from different disciplines or fields that use a variety of research methods , you might want to compare the results and conclusions that emerge from different approaches. For example:

• Look at what results have emerged in qualitative versus quantitative research
• Discuss how the topic has been approached by empirical versus theoretical scholarship
• Divide the literature into sociological, historical, and cultural sources

Theoretical

A literature review is often the foundation for a theoretical framework . You can use it to discuss various theories, models, and definitions of key concepts.

You might argue for the relevance of a specific theoretical approach, or combine various theoretical concepts to create a framework for your research.

Like any other academic text , your literature review should have an introduction , a main body, and a conclusion . What you include in each depends on the objective of your literature review.

The introduction should clearly establish the focus and purpose of the literature review.

Depending on the length of your literature review, you might want to divide the body into subsections. You can use a subheading for each theme, time period, or methodological approach.

As you write, you can follow these tips:

• Summarize and synthesize: give an overview of the main points of each source and combine them into a coherent whole
• Analyze and interpret: don’t just paraphrase other researchers — add your own interpretations where possible, discussing the significance of findings in relation to the literature as a whole
• Critically evaluate: mention the strengths and weaknesses of your sources
• Write in well-structured paragraphs: use transition words and topic sentences to draw connections, comparisons and contrasts

In the conclusion, you should summarize the key findings you have taken from the literature and emphasize their significance.

When you’ve finished writing and revising your literature review, don’t forget to proofread thoroughly before submitting. Not a language expert? Check out Scribbr’s professional proofreading services !

This article has been adapted into lecture slides that you can use to teach your students about writing a literature review.

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If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

• Sampling methods
• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

A literature review is a survey of scholarly sources (such as books, journal articles, and theses) related to a specific topic or research question .

It is often written as part of a thesis, dissertation , or research paper , in order to situate your work in relation to existing knowledge.

There are several reasons to conduct a literature review at the beginning of a research project:

• To familiarize yourself with the current state of knowledge on your topic
• To ensure that you’re not just repeating what others have already done
• To identify gaps in knowledge and unresolved problems that your research can address
• To develop your theoretical framework and methodology
• To provide an overview of the key findings and debates on the topic

Writing the literature review shows your reader how your work relates to existing research and what new insights it will contribute.

The literature review usually comes near the beginning of your thesis or dissertation . After the introduction , it grounds your research in a scholarly field and leads directly to your theoretical framework or methodology .

A literature review is a survey of credible sources on a topic, often used in dissertations , theses, and research papers . Literature reviews give an overview of knowledge on a subject, helping you identify relevant theories and methods, as well as gaps in existing research. Literature reviews are set up similarly to other  academic texts , with an introduction , a main body, and a conclusion .

An  annotated bibliography is a list of  source references that has a short description (called an annotation ) for each of the sources. It is often assigned as part of the research process for a  paper .  

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YSN Doctoral Programs: Steps in Conducting a Literature Review

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• Steps in Conducting a Literature Review

What is a literature review?

A literature review is an integrated analysis -- not just a summary-- of scholarly writings and other relevant evidence related directly to your research question.  That is, it represents a synthesis of the evidence that provides background information on your topic and shows a association between the evidence and your research question.

A literature review may be a stand alone work or the introduction to a larger research paper, depending on the assignment.  Rely heavily on the guidelines your instructor has given you.

Why is it important?

A literature review is important because it:

• Explains the background of research on a topic.
• Demonstrates why a topic is significant to a subject area.
• Discovers relationships between research studies/ideas.
• Identifies major themes, concepts, and researchers on a topic.
• Identifies critical gaps and points of disagreement.
• Discusses further research questions that logically come out of the previous studies.

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1. Choose a topic. Define your research question.

Your literature review should be guided by your central research question.  The literature represents background and research developments related to a specific research question, interpreted and analyzed by you in a synthesized way.

• Make sure your research question is not too broad or too narrow.  Is it manageable?
• Begin writing down terms that are related to your question. These will be useful for searches later.
• If you have the opportunity, discuss your topic with your professor and your class mates.

2. Decide on the scope of your review

How many studies do you need to look at? How comprehensive should it be? How many years should it cover? 

• This may depend on your assignment.  How many sources does the assignment require?

3. Select the databases you will use to conduct your searches.

Make a list of the databases you will search. 

Where to find databases:

• use the tabs on this guide
• Find other databases in the Nursing Information Resources web page
• More on the Medical Library web page
• ... and more on the Yale University Library web page

4. Conduct your searches to find the evidence. Keep track of your searches.

• Use the key words in your question, as well as synonyms for those words, as terms in your search. Use the database tutorials for help.
• Save the searches in the databases. This saves time when you want to redo, or modify, the searches. It is also helpful to use as a guide is the searches are not finding any useful results.
• Review the abstracts of research studies carefully. This will save you time.
• Use the bibliographies and references of research studies you find to locate others.
• Check with your professor, or a subject expert in the field, if you are missing any key works in the field.
• Ask your librarian for help at any time.
• Use a citation manager, such as EndNote as the repository for your citations. See the EndNote tutorials for help.

Review the literature

Some questions to help you analyze the research:

• What was the research question of the study you are reviewing? What were the authors trying to discover?
• Was the research funded by a source that could influence the findings?
• What were the research methodologies? Analyze its literature review, the samples and variables used, the results, and the conclusions.
• Does the research seem to be complete? Could it have been conducted more soundly? What further questions does it raise?
• If there are conflicting studies, why do you think that is?
• How are the authors viewed in the field? Has this study been cited? If so, how has it been analyzed?

Tips: 

• Review the abstracts carefully.  
• Keep careful notes so that you may track your thought processes during the research process.
• Create a matrix of the studies for easy analysis, and synthesis, across all of the studies.
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Research Methods

• Getting Started
• Literature Review Research
• Research Design
• Research Design By Discipline
• SAGE Research Methods
• Teaching with SAGE Research Methods

Literature Review

• What is a Literature Review?
• What is NOT a Literature Review?
• Purposes of a Literature Review
• Types of Literature Reviews
• Literature Reviews vs. Systematic Reviews
• Systematic vs. Meta-Analysis

Literature Review  is a comprehensive survey of the works published in a particular field of study or line of research, usually over a specific period of time, in the form of an in-depth, critical bibliographic essay or annotated list in which attention is drawn to the most significant works.

Also, we can define a literature review as the collected body of scholarly works related to a topic:

• Summarizes and analyzes previous research relevant to a topic
• Includes scholarly books and articles published in academic journals
• Can be an specific scholarly paper or a section in a research paper

The objective of a Literature Review is to find previous published scholarly works relevant to an specific topic

• Help gather ideas or information
• Keep up to date in current trends and findings
• Help develop new questions

A literature review is important because it:

• Explains the background of research on a topic.
• Demonstrates why a topic is significant to a subject area.
• Helps focus your own research questions or problems
• Discovers relationships between research studies/ideas.
• Suggests unexplored ideas or populations
• Identifies major themes, concepts, and researchers on a topic.
• Tests assumptions; may help counter preconceived ideas and remove unconscious bias.
• Identifies critical gaps, points of disagreement, or potentially flawed methodology or theoretical approaches.
• Indicates potential directions for future research.

All content in this section is from Literature Review Research from Old Dominion University 

Keep in mind the following, a literature review is NOT:

Not an essay 

Not an annotated bibliography  in which you summarize each article that you have reviewed.  A literature review goes beyond basic summarizing to focus on the critical analysis of the reviewed works and their relationship to your research question.

Not a research paper   where you select resources to support one side of an issue versus another.  A lit review should explain and consider all sides of an argument in order to avoid bias, and areas of agreement and disagreement should be highlighted.

A literature review serves several purposes. For example, it

• provides thorough knowledge of previous studies; introduces seminal works.
• helps focus one’s own research topic.
• identifies a conceptual framework for one’s own research questions or problems; indicates potential directions for future research.
• suggests previously unused or underused methodologies, designs, quantitative and qualitative strategies.
• identifies gaps in previous studies; identifies flawed methodologies and/or theoretical approaches; avoids replication of mistakes.
• helps the researcher avoid repetition of earlier research.
• suggests unexplored populations.
• determines whether past studies agree or disagree; identifies controversy in the literature.
• tests assumptions; may help counter preconceived ideas and remove unconscious bias.

As Kennedy (2007) notes*, it is important to think of knowledge in a given field as consisting of three layers. First, there are the primary studies that researchers conduct and publish. Second are the reviews of those studies that summarize and offer new interpretations built from and often extending beyond the original studies. Third, there are the perceptions, conclusions, opinion, and interpretations that are shared informally that become part of the lore of field. In composing a literature review, it is important to note that it is often this third layer of knowledge that is cited as "true" even though it often has only a loose relationship to the primary studies and secondary literature reviews.

Given this, while literature reviews are designed to provide an overview and synthesis of pertinent sources you have explored, there are several approaches to how they can be done, depending upon the type of analysis underpinning your study. Listed below are definitions of types of literature reviews:

Argumentative Review      This form examines literature selectively in order to support or refute an argument, deeply imbedded assumption, or philosophical problem already established in the literature. The purpose is to develop a body of literature that establishes a contrarian viewpoint. Given the value-laden nature of some social science research [e.g., educational reform; immigration control], argumentative approaches to analyzing the literature can be a legitimate and important form of discourse. However, note that they can also introduce problems of bias when they are used to to make summary claims of the sort found in systematic reviews.

Integrative Review      Considered a form of research that reviews, critiques, and synthesizes representative literature on a topic in an integrated way such that new frameworks and perspectives on the topic are generated. The body of literature includes all studies that address related or identical hypotheses. A well-done integrative review meets the same standards as primary research in regard to clarity, rigor, and replication.

Historical Review      Few things rest in isolation from historical precedent. Historical reviews are focused on examining research throughout a period of time, often starting with the first time an issue, concept, theory, phenomena emerged in the literature, then tracing its evolution within the scholarship of a discipline. The purpose is to place research in a historical context to show familiarity with state-of-the-art developments and to identify the likely directions for future research.

Methodological Review      A review does not always focus on what someone said [content], but how they said it [method of analysis]. This approach provides a framework of understanding at different levels (i.e. those of theory, substantive fields, research approaches and data collection and analysis techniques), enables researchers to draw on a wide variety of knowledge ranging from the conceptual level to practical documents for use in fieldwork in the areas of ontological and epistemological consideration, quantitative and qualitative integration, sampling, interviewing, data collection and data analysis, and helps highlight many ethical issues which we should be aware of and consider as we go through our study.

Systematic Review      This form consists of an overview of existing evidence pertinent to a clearly formulated research question, which uses pre-specified and standardized methods to identify and critically appraise relevant research, and to collect, report, and analyse data from the studies that are included in the review. Typically it focuses on a very specific empirical question, often posed in a cause-and-effect form, such as "To what extent does A contribute to B?"

Theoretical Review      The purpose of this form is to concretely examine the corpus of theory that has accumulated in regard to an issue, concept, theory, phenomena. The theoretical literature review help establish what theories already exist, the relationships between them, to what degree the existing theories have been investigated, and to develop new hypotheses to be tested. Often this form is used to help establish a lack of appropriate theories or reveal that current theories are inadequate for explaining new or emerging research problems. The unit of analysis can focus on a theoretical concept or a whole theory or framework.

* Kennedy, Mary M. "Defining a Literature."  Educational Researcher  36 (April 2007): 139-147.

All content in this section is from The Literature Review created by Dr. Robert Larabee USC

Robinson, P. and Lowe, J. (2015),  Literature reviews vs systematic reviews.  Australian and New Zealand Journal of Public Health, 39: 103-103. doi: 10.1111/1753-6405.12393

What's in the name? The difference between a Systematic Review and a Literature Review, and why it matters . By Lynn Kysh from University of Southern California

Systematic review or meta-analysis?

A  systematic review  answers a defined research question by collecting and summarizing all empirical evidence that fits pre-specified eligibility criteria.

A  meta-analysis  is the use of statistical methods to summarize the results of these studies.

Systematic reviews, just like other research articles, can be of varying quality. They are a significant piece of work (the Centre for Reviews and Dissemination at York estimates that a team will take 9-24 months), and to be useful to other researchers and practitioners they should have:

• clearly stated objectives with pre-defined eligibility criteria for studies
• explicit, reproducible methodology
• a systematic search that attempts to identify all studies
• assessment of the validity of the findings of the included studies (e.g. risk of bias)
• systematic presentation, and synthesis, of the characteristics and findings of the included studies

Not all systematic reviews contain meta-analysis. 

Meta-analysis is the use of statistical methods to summarize the results of independent studies. By combining information from all relevant studies, meta-analysis can provide more precise estimates of the effects of health care than those derived from the individual studies included within a review.  More information on meta-analyses can be found in  Cochrane Handbook, Chapter 9 .

A meta-analysis goes beyond critique and integration and conducts secondary statistical analysis on the outcomes of similar studies.  It is a systematic review that uses quantitative methods to synthesize and summarize the results.

An advantage of a meta-analysis is the ability to be completely objective in evaluating research findings.  Not all topics, however, have sufficient research evidence to allow a meta-analysis to be conducted.  In that case, an integrative review is an appropriate strategy. 

Some of the content in this section is from Systematic reviews and meta-analyses: step by step guide created by Kate McAllister.

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Writing a Literature Review

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A literature review is a document or section of a document that collects key sources on a topic and discusses those sources in conversation with each other (also called synthesis ). The lit review is an important genre in many disciplines, not just literature (i.e., the study of works of literature such as novels and plays). When we say “literature review” or refer to “the literature,” we are talking about the research ( scholarship ) in a given field. You will often see the terms “the research,” “the scholarship,” and “the literature” used mostly interchangeably.

Where, when, and why would I write a lit review?

There are a number of different situations where you might write a literature review, each with slightly different expectations; different disciplines, too, have field-specific expectations for what a literature review is and does. For instance, in the humanities, authors might include more overt argumentation and interpretation of source material in their literature reviews, whereas in the sciences, authors are more likely to report study designs and results in their literature reviews; these differences reflect these disciplines’ purposes and conventions in scholarship. You should always look at examples from your own discipline and talk to professors or mentors in your field to be sure you understand your discipline’s conventions, for literature reviews as well as for any other genre.

A literature review can be a part of a research paper or scholarly article, usually falling after the introduction and before the research methods sections. In these cases, the lit review just needs to cover scholarship that is important to the issue you are writing about; sometimes it will also cover key sources that informed your research methodology.

Lit reviews can also be standalone pieces, either as assignments in a class or as publications. In a class, a lit review may be assigned to help students familiarize themselves with a topic and with scholarship in their field, get an idea of the other researchers working on the topic they’re interested in, find gaps in existing research in order to propose new projects, and/or develop a theoretical framework and methodology for later research. As a publication, a lit review usually is meant to help make other scholars’ lives easier by collecting and summarizing, synthesizing, and analyzing existing research on a topic. This can be especially helpful for students or scholars getting into a new research area, or for directing an entire community of scholars toward questions that have not yet been answered.

What are the parts of a lit review?

Most lit reviews use a basic introduction-body-conclusion structure; if your lit review is part of a larger paper, the introduction and conclusion pieces may be just a few sentences while you focus most of your attention on the body. If your lit review is a standalone piece, the introduction and conclusion take up more space and give you a place to discuss your goals, research methods, and conclusions separately from where you discuss the literature itself.

Introduction:

• An introductory paragraph that explains what your working topic and thesis is
• A forecast of key topics or texts that will appear in the review
• Potentially, a description of how you found sources and how you analyzed them for inclusion and discussion in the review (more often found in published, standalone literature reviews than in lit review sections in an article or research paper)
• Summarize and synthesize: Give an overview of the main points of each source and combine them into a coherent whole
• Analyze and interpret: Don’t just paraphrase other researchers – add your own interpretations where possible, discussing the significance of findings in relation to the literature as a whole
• Critically Evaluate: Mention the strengths and weaknesses of your sources
• Write in well-structured paragraphs: Use transition words and topic sentence to draw connections, comparisons, and contrasts.

Conclusion:

• Summarize the key findings you have taken from the literature and emphasize their significance
• Connect it back to your primary research question

How should I organize my lit review?

Lit reviews can take many different organizational patterns depending on what you are trying to accomplish with the review. Here are some examples:

• Chronological : The simplest approach is to trace the development of the topic over time, which helps familiarize the audience with the topic (for instance if you are introducing something that is not commonly known in your field). If you choose this strategy, be careful to avoid simply listing and summarizing sources in order. Try to analyze the patterns, turning points, and key debates that have shaped the direction of the field. Give your interpretation of how and why certain developments occurred (as mentioned previously, this may not be appropriate in your discipline — check with a teacher or mentor if you’re unsure).
• Thematic : If you have found some recurring central themes that you will continue working with throughout your piece, you can organize your literature review into subsections that address different aspects of the topic. For example, if you are reviewing literature about women and religion, key themes can include the role of women in churches and the religious attitude towards women.
• Qualitative versus quantitative research
• Empirical versus theoretical scholarship
• Divide the research by sociological, historical, or cultural sources
• Theoretical : In many humanities articles, the literature review is the foundation for the theoretical framework. You can use it to discuss various theories, models, and definitions of key concepts. You can argue for the relevance of a specific theoretical approach or combine various theorical concepts to create a framework for your research.

What are some strategies or tips I can use while writing my lit review?

Any lit review is only as good as the research it discusses; make sure your sources are well-chosen and your research is thorough. Don’t be afraid to do more research if you discover a new thread as you’re writing. More info on the research process is available in our "Conducting Research" resources .

As you’re doing your research, create an annotated bibliography ( see our page on the this type of document ). Much of the information used in an annotated bibliography can be used also in a literature review, so you’ll be not only partially drafting your lit review as you research, but also developing your sense of the larger conversation going on among scholars, professionals, and any other stakeholders in your topic.

Usually you will need to synthesize research rather than just summarizing it. This means drawing connections between sources to create a picture of the scholarly conversation on a topic over time. Many student writers struggle to synthesize because they feel they don’t have anything to add to the scholars they are citing; here are some strategies to help you:

• It often helps to remember that the point of these kinds of syntheses is to show your readers how you understand your research, to help them read the rest of your paper.
• Writing teachers often say synthesis is like hosting a dinner party: imagine all your sources are together in a room, discussing your topic. What are they saying to each other?
• Look at the in-text citations in each paragraph. Are you citing just one source for each paragraph? This usually indicates summary only. When you have multiple sources cited in a paragraph, you are more likely to be synthesizing them (not always, but often
• Read more about synthesis here.

The most interesting literature reviews are often written as arguments (again, as mentioned at the beginning of the page, this is discipline-specific and doesn’t work for all situations). Often, the literature review is where you can establish your research as filling a particular gap or as relevant in a particular way. You have some chance to do this in your introduction in an article, but the literature review section gives a more extended opportunity to establish the conversation in the way you would like your readers to see it. You can choose the intellectual lineage you would like to be part of and whose definitions matter most to your thinking (mostly humanities-specific, but this goes for sciences as well). In addressing these points, you argue for your place in the conversation, which tends to make the lit review more compelling than a simple reporting of other sources.

Research Methods: Literature Reviews

• Annotated Bibliographies
• Literature Reviews
• Scoping Reviews
• Systematic Reviews
• Scholarship of Teaching and Learning
• Persuasive Arguments
• Subject Specific Methodology

A literature review involves researching, reading, analyzing, evaluating, and summarizing scholarly literature (typically journals and articles) about a specific topic. The results of a literature review may be an entire report or article OR may be part of a article, thesis, dissertation, or grant proposal. A literature review helps the author learn about the history and nature of their topic, and identify research gaps and problems.

Steps & Elements

Problem formulation

• Determine your topic and its components by asking a question
• Research: locate literature related to your topic to identify the gap(s) that can be addressed
• Read: read the articles or other sources of information
• Analyze: assess the findings for relevancy
• Evaluating: determine how the article are relevant to your research and what are the key findings
• Synthesis: write about the key findings and how it is relevant to your research

Elements of a Literature Review

• Summarize subject, issue or theory under consideration, along with objectives of the review
• Divide works under review into categories (e.g. those in support of a particular position, those against, those offering alternative theories entirely)
• Explain how each work is similar to and how it varies from the others
• Conclude which pieces are best considered in their argument, are most convincing of their opinions, and make the greatest contribution to the understanding and development of an area of research

Writing a Literature Review Resources

• How to Write a Literature Review From the Wesleyan University Library
• Write a Literature Review From the University of California Santa Cruz Library. A Brief overview of a literature review, includes a list of stages for writing a lit review.
• Literature Reviews From the University of North Carolina Writing Center. Detailed information about writing a literature review.
• Undertaking a literature review: a step-by-step approach Cronin, P., Ryan, F., & Coughan, M. (2008). Undertaking a literature review: A step-by-step approach. British Journal of Nursing, 17(1), p.38-43

Literature Review Tutorial

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Literature Reviews: Writing the Review

Outline of review sections.

Your Literature Review should not be a summary and evaluation of each article, one after the other. Your sources should be integrated together to create a narrative on your topic.

Consider the following ways to organize your review:

• By themes, variables, or issues
• By varying perspectives regarding a topic of controversy
• Chronologically, to show how the topic and research have developed over time

Use an outline to organize your sources and ideas in a logical sequence. Identify main points and subpoints, and consider the flow of your review. Outlines can be revised as your ideas develop. They help guide your readers through your ideas and show the hierarchy of your thoughts. What do your readers need to understand first? Where might certain studies fit most naturally? These are the kinds of questions that an outline can clarify.

An example outline for a Literature Review might look like this:

Introduction

• Background information on the topic & definitions
• Purpose of the literature review
• Scope and limitations of the review (what is included /excluded)
• Historical background 
• Overview of the existing research on the topic
• Principle question being asked
• Organization of the literature into categories or themes
• Evaluation of the strengths and weaknesses of each study
• Combining the findings from multiple sources to identify patterns and trends
• Insight into the relationship between your central topic and a larger area of study
• Development of a new research question or hypothesis
• Summary of the key points and findings in the literature
• Discussion of gaps in the existing knowledge
• Implications for future research

Strategies for Writing

Annotated bibliography.

An annotated bibliography collects short descriptions of each source in one place. After you have read each source carefully, set aside some time to write a brief summary. Your summary might be simply informative (e.g. identify the main argument/hypothesis, methods, major findings, and/or conclusions), or it might be evaluative (e.g. state why the source is interesting or useful for your review, or why it is not).

This method is more narrative than the Literature Matrix talked about on the Documenting Your Search page.

Taking the time to write short informative and/or evaluative summaries of your sources while you are researching can help you transition into the drafting stage later on. By making a record of your sources’ contents and your reactions to them, you make it less likely that you will need to go back and re-read many sources while drafting, and you might also start to gain a clearer idea of the overarching shape of your review.

READ EXTANT LIT REVIEWS CLOSELY

As you conduct your research, you will likely read many sources that model the same kind of literature review that you are researching and writing. While your original intent in reading those sources is likely to learn from the studies’ content (e.g. their results and discussion), it will benefit you to re-read these articles rhetorically.

Reading rhetorically means paying attention to how a text is written—how it has been structured, how it presents its claims and analyses, how it employs transitional words and phrases to move from one idea to the next. You might also pay attention to an author’s stylistic choices, like the use of first-person pronouns, active and passive voice, or technical terminology.

See  Finding Example Literature Reviews on the Developing a Research Question page for tips on finding reviews relevant to your topic.

MIND-MAPPING

Creating a mind-map is a form of brainstorming that lets you visualize how your ideas function and relate. Draw the diagram freehand or download software that lets you easily manipulate and group text, images, and shapes ( Coggle ,  FreeMind , MindMaple ).

Write down a central idea, then identify associated concepts, features, or questions around that idea. Make lines attaching various ideas, or arrows to signify directional relationships. Use different shapes, sizes, or colors to indicate commonalities, sequences, or relative importance.

This drafting technique allows you to generate ideas while thinking visually about how they function together. As you follow lines of thought, you can see which ideas can be connected, where certain pathways lead, and what the scope of your project might be. By drawing out a mind-map you may be able to see what elements of your review are underdeveloped and will benefit from more focused attention.

USE VISUALIZATION TOOLS

Attribution.

Thanks to Librarian Jamie Niehof at the University of Michigan for providing permission to reuse and remix this Literature Reviews guide.

Avoiding Bias

Reporting bias.

This occurs when you are summarizing the literature in an unbalanced, inconsistent or distorted way . 

Ways to avoid:

• look for literature that supports multiple perspectives, viewpoints or theories 
• ask multiple people to review your writing for bias
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• Volume 24, Issue 2
• Five tips for developing useful literature summary tables for writing review articles
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• http://orcid.org/0000-0003-0157-5319 Ahtisham Younas 1 , 2 ,
• http://orcid.org/0000-0002-7839-8130 Parveen Ali 3 , 4
• 1 Memorial University of Newfoundland , St John's , Newfoundland , Canada
• 2 Swat College of Nursing , Pakistan
• 3 School of Nursing and Midwifery , University of Sheffield , Sheffield , South Yorkshire , UK
• 4 Sheffield University Interpersonal Violence Research Group , Sheffield University , Sheffield , UK
• Correspondence to Ahtisham Younas, Memorial University of Newfoundland, St John's, NL A1C 5C4, Canada; ay6133{at}mun.ca

https://doi.org/10.1136/ebnurs-2021-103417

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Introduction

Literature reviews offer a critical synthesis of empirical and theoretical literature to assess the strength of evidence, develop guidelines for practice and policymaking, and identify areas for future research. 1 It is often essential and usually the first task in any research endeavour, particularly in masters or doctoral level education. For effective data extraction and rigorous synthesis in reviews, the use of literature summary tables is of utmost importance. A literature summary table provides a synopsis of an included article. It succinctly presents its purpose, methods, findings and other relevant information pertinent to the review. The aim of developing these literature summary tables is to provide the reader with the information at one glance. Since there are multiple types of reviews (eg, systematic, integrative, scoping, critical and mixed methods) with distinct purposes and techniques, 2 there could be various approaches for developing literature summary tables making it a complex task specialty for the novice researchers or reviewers. Here, we offer five tips for authors of the review articles, relevant to all types of reviews, for creating useful and relevant literature summary tables. We also provide examples from our published reviews to illustrate how useful literature summary tables can be developed and what sort of information should be provided.

Tip 1: provide detailed information about frameworks and methods

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Tabular literature summaries from a scoping review. Source: Rasheed et al . 3

The provision of information about conceptual and theoretical frameworks and methods is useful for several reasons. First, in quantitative (reviews synthesising the results of quantitative studies) and mixed reviews (reviews synthesising the results of both qualitative and quantitative studies to address a mixed review question), it allows the readers to assess the congruence of the core findings and methods with the adapted framework and tested assumptions. In qualitative reviews (reviews synthesising results of qualitative studies), this information is beneficial for readers to recognise the underlying philosophical and paradigmatic stance of the authors of the included articles. For example, imagine the authors of an article, included in a review, used phenomenological inquiry for their research. In that case, the review authors and the readers of the review need to know what kind of (transcendental or hermeneutic) philosophical stance guided the inquiry. Review authors should, therefore, include the philosophical stance in their literature summary for the particular article. Second, information about frameworks and methods enables review authors and readers to judge the quality of the research, which allows for discerning the strengths and limitations of the article. For example, if authors of an included article intended to develop a new scale and test its psychometric properties. To achieve this aim, they used a convenience sample of 150 participants and performed exploratory (EFA) and confirmatory factor analysis (CFA) on the same sample. Such an approach would indicate a flawed methodology because EFA and CFA should not be conducted on the same sample. The review authors must include this information in their summary table. Omitting this information from a summary could lead to the inclusion of a flawed article in the review, thereby jeopardising the review’s rigour.

Tip 2: include strengths and limitations for each article

Critical appraisal of individual articles included in a review is crucial for increasing the rigour of the review. Despite using various templates for critical appraisal, authors often do not provide detailed information about each reviewed article’s strengths and limitations. Merely noting the quality score based on standardised critical appraisal templates is not adequate because the readers should be able to identify the reasons for assigning a weak or moderate rating. Many recent critical appraisal checklists (eg, Mixed Methods Appraisal Tool) discourage review authors from assigning a quality score and recommend noting the main strengths and limitations of included studies. It is also vital that methodological and conceptual limitations and strengths of the articles included in the review are provided because not all review articles include empirical research papers. Rather some review synthesises the theoretical aspects of articles. Providing information about conceptual limitations is also important for readers to judge the quality of foundations of the research. For example, if you included a mixed-methods study in the review, reporting the methodological and conceptual limitations about ‘integration’ is critical for evaluating the study’s strength. Suppose the authors only collected qualitative and quantitative data and did not state the intent and timing of integration. In that case, the strength of the study is weak. Integration only occurred at the levels of data collection. However, integration may not have occurred at the analysis, interpretation and reporting levels.

Tip 3: write conceptual contribution of each reviewed article

While reading and evaluating review papers, we have observed that many review authors only provide core results of the article included in a review and do not explain the conceptual contribution offered by the included article. We refer to conceptual contribution as a description of how the article’s key results contribute towards the development of potential codes, themes or subthemes, or emerging patterns that are reported as the review findings. For example, the authors of a review article noted that one of the research articles included in their review demonstrated the usefulness of case studies and reflective logs as strategies for fostering compassion in nursing students. The conceptual contribution of this research article could be that experiential learning is one way to teach compassion to nursing students, as supported by case studies and reflective logs. This conceptual contribution of the article should be mentioned in the literature summary table. Delineating each reviewed article’s conceptual contribution is particularly beneficial in qualitative reviews, mixed-methods reviews, and critical reviews that often focus on developing models and describing or explaining various phenomena. Figure 2 offers an example of a literature summary table. 4

Tabular literature summaries from a critical review. Source: Younas and Maddigan. 4

Tip 4: compose potential themes from each article during summary writing

While developing literature summary tables, many authors use themes or subthemes reported in the given articles as the key results of their own review. Such an approach prevents the review authors from understanding the article’s conceptual contribution, developing rigorous synthesis and drawing reasonable interpretations of results from an individual article. Ultimately, it affects the generation of novel review findings. For example, one of the articles about women’s healthcare-seeking behaviours in developing countries reported a theme ‘social-cultural determinants of health as precursors of delays’. Instead of using this theme as one of the review findings, the reviewers should read and interpret beyond the given description in an article, compare and contrast themes, findings from one article with findings and themes from another article to find similarities and differences and to understand and explain bigger picture for their readers. Therefore, while developing literature summary tables, think twice before using the predeveloped themes. Including your themes in the summary tables (see figure 1 ) demonstrates to the readers that a robust method of data extraction and synthesis has been followed.

Tip 5: create your personalised template for literature summaries

Often templates are available for data extraction and development of literature summary tables. The available templates may be in the form of a table, chart or a structured framework that extracts some essential information about every article. The commonly used information may include authors, purpose, methods, key results and quality scores. While extracting all relevant information is important, such templates should be tailored to meet the needs of the individuals’ review. For example, for a review about the effectiveness of healthcare interventions, a literature summary table must include information about the intervention, its type, content timing, duration, setting, effectiveness, negative consequences, and receivers and implementers’ experiences of its usage. Similarly, literature summary tables for articles included in a meta-synthesis must include information about the participants’ characteristics, research context and conceptual contribution of each reviewed article so as to help the reader make an informed decision about the usefulness or lack of usefulness of the individual article in the review and the whole review.

In conclusion, narrative or systematic reviews are almost always conducted as a part of any educational project (thesis or dissertation) or academic or clinical research. Literature reviews are the foundation of research on a given topic. Robust and high-quality reviews play an instrumental role in guiding research, practice and policymaking. However, the quality of reviews is also contingent on rigorous data extraction and synthesis, which require developing literature summaries. We have outlined five tips that could enhance the quality of the data extraction and synthesis process by developing useful literature summaries.

• Aromataris E ,
• Rasheed SP ,

Twitter @Ahtisham04, @parveenazamali

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Patient consent for publication Not required.

Provenance and peer review Not commissioned; externally peer reviewed.

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Toward a framework for selecting indicators of measuring sustainability and circular economy in the agri-food sector: a systematic literature review

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• Published: 02 March 2022

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• Cecilia Silvestri   ORCID: orcid.org/0000-0003-2528-601X 1 ,
• Luca Silvestri   ORCID: orcid.org/0000-0002-6754-899X 2 ,
• Michela Piccarozzi   ORCID: orcid.org/0000-0001-9717-9462 1 &
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A Correction to this article was published on 24 March 2022

This article has been updated

The implementation of sustainability and circular economy (CE) models in agri-food production can promote resource efficiency, reduce environmental burdens, and ensure improved and socially responsible systems. In this context, indicators for the measurement of sustainability play a crucial role. Indicators can measure CE strategies aimed to preserve functions, products, components, materials, or embodied energy. Although there is broad literature describing sustainability and CE indicators, no study offers such a comprehensive framework of indicators for measuring sustainability and CE in the agri-food sector.

Starting from this central research gap, a systematic literature review has been developed to measure the sustainability in the agri-food sector and, based on these findings, to understand how indicators are used and for which specific purposes.

The analysis of the results allowed us to classify the sample of articles in three main clusters (“Assessment-LCA,” “Best practice,” and “Decision-making”) and has shown increasing attention to the three pillars of sustainability (triple bottom line). In this context, an integrated approach of indicators (environmental, social, and economic) offers the best solution to ensure an easier transition to sustainability.

Conclusions

The sample analysis facilitated the identification of new categories of impact that deserve attention, such as the cooperation among stakeholders in the supply chain and eco-innovation.

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Source: Authors’ elaboration. Notes: The graph shows the temporal distribution of the articles under analysis

Source: Authors’ elaborations. Notes: The graph shows the time distribution of articles from the three major journals

Source: Authors’ elaboration. Notes: The graph shows the composition of the sample according to the three clusters identified by the analysis

Source: Authors’ elaboration. Notes: The graph shows the distribution of articles over time by cluster

Source: Authors’ elaboration. Notes: The graph shows the network visualization

Source: Authors’ elaboration. Notes: The graph shows the overlay visualization

Source: Authors’ elaboration. Notes: The graph shows the classification of articles by scientific field

Source: Authors’ elaboration. Notes: Article classification based on their cluster to which they belong and scientific field

Source: Authors’ elaboration

Source: Authors’ elaboration. Notes: The graph shows the distribution of items over time based on TBL

Source: Authors’ elaboration. Notes: The graph shows the Pareto diagram highlighting the most used indicators in literature for measuring sustainability in the agri-food sector

Source: Authors’ elaboration. Notes: The graph shows the distribution over time of articles divided into conceptual and empirical

Source: Authors’ elaboration. Notes: The graph shows the classification of articles, divided into conceptual and empirical, in-depth analysis

Source: Authors’ elaboration. Notes: The graph shows the geographical distribution of the authors

Source: Authors’ elaboration. Notes: The graph shows the distribution of authors according to the continent from which they originate

Source: Authors’ elaboration. Notes: The graph shows the time distribution of publication of authors according to the continent from which they originate

Source: Authors’ elaboration. Notes: Sustainability measurement indicators and impact categories of LCA, S-LCA, and LCC tools should be integrated in order to provide stakeholders with best practices as guidelines and tools to support both decision-making and measurement, according to the circular economy approach

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Change history, 24 march 2022.

A Correction to this paper has been published: https://doi.org/10.1007/s11367-022-02038-9

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Development of an index system for the scientific literacy of medical staff: a modified Delphi study in China

• Shuyu Liang 2   na1 ,
• Ziyan Zhai 2   na1 ,
• Xingmiao Feng 2 ,
• Xiaozhi Sun 1 ,
• Jingxuan Jiao 1 ,
• Yuan Gao 1   na2 &
• Kai Meng   ORCID: orcid.org/0000-0003-1467-7904 2 , 3   na2  

BMC Medical Education volume  24 , Article number:  397 ( 2024 ) Cite this article

Metrics details

Scientific research activity in hospitals is important for promoting the development of clinical medicine, and the scientific literacy of medical staff plays an important role in improving the quality and competitiveness of hospital research. To date, no index system applicable to the scientific literacy of medical staff in China has been developed that can effectively evaluate and guide scientific literacy. This study aimed to establish an index system for the scientific literacy of medical staff in China and provide a reference for improving the evaluation of this system.

In this study, a preliminary indicator pool for the scientific literacy of medical staff was constructed through the nominal group technique ( n  = 16) with medical staff. Then, two rounds of Delphi expert consultation surveys ( n  = 20) were conducted with clinicians, and the indicators were screened, revised and supplemented using the boundary value method and expert opinions. Next, the hierarchical analysis method was utilized to determine the weights of the indicators and ultimately establish a scientific literacy indicator system for medical staff.

Following expert opinion, the index system for the scientific literacy of medical staff featuring 2 first-level indicators, 9 second-level indicators, and 38 third-level indicators was ultimately established, and the weights of the indicators were calculated. The two first-level indicators were research literacy and research ability, and the second-level indicators were research attitude (0.375), ability to identify problems (0.2038), basic literacy (0.1250), ability to implement projects (0.0843), research output capacity (0.0747), professional capacity (0.0735), data-processing capacity (0.0239), thesis-writing skills (0.0217), and ability to use literature (0.0181).

Conclusions

This study constructed a comprehensive scientific literacy index system that can assess medical staff's scientific literacy and serve as a reference for evaluating and improving their scientific literacy.

Peer Review reports

Due to the accelerated aging of the population and the growing global demand for healthcare in the wake of epidemics, there is an urgent need for medicine to provide greater support and protection. Medical scientific research is a critical element in promoting medical science and technological innovation, as well as improving clinical diagnosis and treatment techniques. It is the main driving force for the development of healthcare [ 1 ].

Medical personnel are highly compatible with clinical research. Due to their close interaction with patients, medical staff are better equipped to identify pertinent clinical research issues and actually implement clinical research projects [ 2 ]. Countries have created favorable conditions for the research and development of medical personnel by providing financial support, developing policies, and offering training courses [ 3 , 4 ]. However, some clinical studies have shown that the ability of most medical staff does not match current health needs and cannot meet the challenges posed by the twenty-first century [ 5 ]. It is clear that highly skilled professionals with scientific literacy are essential for national and social development [ 6 ]. Given the importance of scientific research in countries and hospitals, it is crucial to determine the level of scientific research literacy that medical personnel should possess and how to train them to acquire the necessary scientific research skills. These issues have significant practical implications.

Scientific literacy refers to an individual's ability to engage in science-related activities [ 7 ]. Some scholars suggest that the scientific literacy of medical personnel encompasses the fundamental qualities required for scientific research work, encompassing three facets: academic moral accomplishment, scientific research theory accomplishment, and scientific research ability accomplishment [ 8 ]. The existing research has focused primarily on the research capabilities of medical staff. According to Rillero, problem-solving skills, critical thinking, communication skills, and the ability to interpret data are the four core components of scientific literacy [ 9 ]. The ability to perform scientific research in nursing encompasses a range of abilities, including identifying problems, conducting literature reviews, designing and conducting scientific research, practicing scientific research, processing data, and writing papers [ 10 ]. Moule and Goodman proposed a framework of skills that research-literate nurses should possess, such as critical thinking capacity, analytical skills, searching skills, research critique skills, the ability to read and critically appraise research, and an awareness of ethical issues [ 11 ]. Several researchers have developed self-evaluation questionnaires to assess young researchers' scientific research and innovative abilities in the context of university-affiliated hospitals (UHAs) [ 12 ]. The relevant indicators include sensitivity to problems, sensitivity to cutting-edge knowledge, critical thinking, and other aspects. While these indicators cover many factors, they do not consider the issue of scientific research integrity in the medical field. The lack of detailed and targeted indicators, such as clinical resource collection ability and interdisciplinary cooperation ability, hinders the effective measurement of the current status of scientific literacy among medical staff [ 12 ]. In conclusion, the current research on the evaluation indicators of scientific literacy among medical personnel is incomplete, overlooking crucial humanistic characteristics, attitudes, and other moral literacy factors. Therefore, there is an urgent need to establish a comprehensive and systematic evaluation index to effectively assess the scientific literacy of medical staff.

Therefore, this study utilized a literature search and nominal group technique to screen the initial evaluation index and subsequently constructed an evaluation index system for medical staff's scientific research literacy utilizing the Delphi method. This index system would serve as a valuable tool for hospital managers, aiding them in the selection, evaluation, and training of scientific research talent. Additionally, this approach would enable medical personnel to identify their own areas of weakness and implement targeted improvement strategies.

Patient and public involvement

Patients and the public were not involved in this research.

Study design and participants

In this study, an initial evaluation index system was developed through a literature review and nominal group technique. Subsequently, a more comprehensive and scientific index system was constructed by combining qualitative and quantitative analysis utilizing the Delphi method to consult with experts. Finally, the hierarchical analysis method and the percentage weight method were employed to empower the index system.

The program used for this study is shown in Fig.  1 .

Study design. AHP, analytic hierarchy process

Establishing the preliminary indicator pool

Search process.

A literature search was performed in the China National Knowledge Infrastructure (CNKI), WanFang, PubMed, Web of Science and Scopus databases to collect the initial evaluation indicators. The time span ranged from the establishment of the database to July 2022. We used a combination of several MeSH terms in our searches:(("Medical Staff"[Mesh] OR "Nurses"[Mesh] OR "Physicians"[Mesh])) AND (("Literacy"[Mesh]) OR "Aptitude"[Mesh]). We also used several Title/Abstract searches, including keywords such as: Evaluation, scientific literacy, research ability.

The inclusion criteria were as follows: (1)The subjects were nurses, medicial staff and other personnel engaged in the medical industry; (2) Explore topics related to scientific literacy, such as research ability, and literature that can clarify the structure or dependency between indicators of scientific literacy; (3) Select articles published in countries such as China, the United States, the United Kingdom, Australia and Canada; (4) Research published in English or Chinese is considered to be eligible. The exclusion criteria are as follows: (1) indicators not applicable to medical staff; (2) Conference abstracts, case reports or review papers; (3) Articles with repeated descriptions; (4) There are no full-text articles or grey literature. A total of 78 articles were retrieved and 60 were retained after screening according to inclusion and exclusion criteria.

The research was conducted by two graduate students and two undergraduate students who participated in the literature search and screening. The entire research process was supervised and guided by one professor. All five members were from the fields of social medicine and health management. The professor was engaged in hospital management and health policy research for many years.

Nominal group technique

The nominal group technique was introduced at Hospital H in Beijing in July 2022. This hospital, with over 2,500 beds and 3,000 doctors, is a leading comprehensive medical center also known for its educational and research achievements, including numerous national research projects and awards.

The interview questions were based on the research question: What research literacy should medical staff have? 16 clinicians and nurses from Hospital H were divided into 2 equal groups and asked to provide their opinions on important aspects of research literacy based on their positions and experiences. Once all participants had shared their thoughts, similar responses were merged and polished. If anyone had further inputs after this, a second round of interviews was held until no new inputs were given. The entire meeting, including both rounds, was documented by researchers with audio recordings on a tape recorder.

Scientific literacy dimensions

Based on the search process, the research group extracted 58 tertiary indicators. To ensure the practicality and comprehensiveness of the indicators, the Nominal group technique was used on the basis of the literature search. Panelists summarized the entries shown in the interviews and merged similar content to obtain 32 third-level indicators. The indicators obtained from the literature search were compared. Several indicators with similar meanings, such as capture information ability, language expression ability, communication ability, and scientific research integrity, were merged. Additionally, the indicators obtained from the literature search, such as scientific research ethics, database use ability, feasibility and analysis ability, were added to the 15 indicators. A total of 47 third-level indicators were identified.

Fengling Dai and colleagues developed an innovation ability index system with six dimensions covering problem discovery, information retrieval, research design, practice, data analysis, and report writing, which represents the whole of innovative activity. Additionally, the system includes an innovation spirit index focusing on motivation, thinking, emotion, and will, reflecting the core of the innovation process in terms of competence [ 13 ]. Liao et al. evaluated the following five dimensions in their study on scientific research competence: literature processing, experimental manipulation, statistical analysis, manuscript production, and innovative project design [ 14 ]. Mohan claimed that scientific literacy consists of four core components: problem solving, critical thinking, communication skills, and the ability to interpret data [ 15 ].

This study structured scientific literacy into 2 primary indicators (research literacy and research competence) and 9 secondary indicators (basic qualifications, research ethics, research attitude, problem identification, literature use, professional capacity, subject implementation, data processing, thesis writing, and research output).

Using the Delphi method to develop an index system

Expert selection.

This study used the Delphi method to distribute expert consultation questionnaires online, allowing experts to exchange opinions anonymously to ensure that the findings were more desirable and scientific. No fixed number of experts is required for a Delphi study, but the more experts involved, the more stable the results will be [ 16 ]; this method generally includes 15 to 50 experts [ 17 ]. We selected clinicians from several tertiary hospitals in the Beijing area to serve as Delphi study consultants based on the following inclusion criteria: (1) they had a title of senior associate or above; (2) they had more than 10 years of work experience in the field of clinical scientific research, and (3) they were presiding over national scientific research projects. The exclusion criteria were as follows: (1) full-time scientific researchers, and (2) personnel in hospitals who were engaged only in management. To ensure that the selected experts were representative, this study selected 20 experts from 14 tertiary hospitals affiliated with Capital Medical University, Peking University, the Chinese Academy of Medical Sciences and the China Academy of Traditional Chinese Medicine according to the inclusion criteria; the hospitals featured an average of 1,231 beds each, and 9 hospitals were included among the 77 hospitals in the domestic comprehensive hospital ranking (Fudan Hospital Management Institute ranking). The experts represented various specialties and roles from different hospitals, including cardiology, neurosurgery, neurology, ear and throat surgery, head and neck surgery, radiology, imaging, infection, vascular interventional oncology, pediatrics, general practice, hematology, stomatology, nephrology, urology, and other related fields. This diverse group included physicians, nurses, managers, and vice presidents. The selected experts had extensive clinical experience, achieved numerous scientific research accomplishments and possessed profound knowledge and experience in clinical scientific research. This ensured the reliability of the consultation outcomes.

Design of the expert consultation questionnaire

The Delphi survey for experts included sections on their background, familiarity with the indicator system, system evaluation, and opinions. Experts rated indicators on importance, feasibility, and sensitivity using a 1–10 scale and their own familiarity with the indicators on a 1–5 scale. They also scored their judgment basis and impact on a 1–3 scale, considering theoretical analysis, work experience, peer understanding, and intuition. Two rounds of Delphi surveys were carried out via email with 20 experts to evaluate and suggest changes to the indicators. Statistical coefficients were calculated to validate the Delphi process. Feedback from the first round led to modifications and the inclusion of an AHP questionnaire for the second round. After the second round, indicators deemed less important were removed, and expert discussion finalized the indicator weights based on their relative importance scores. This resulted in the development of an index system for medical staff scientific literacy. The questionnaire is included in Additional file 1 (first round) and Additional file 2 (second round).

Using the boundary value method to screen the indicators

In this study, the boundary value method was utilized to screen the indicators of medical staff's scientific literacy, and the importance, feasibility, and sensitivity of each indicator were measured using the frequency of perfect scores, the arithmetic mean, and the coefficient of variation, respectively. When calculating the frequency of perfect scores and arithmetic means, the boundary value was set as "mean-SD," and indicators with scores higher than this value were retained. When calculating the coefficient of variation, the cutoff value was set to "mean + SD," and indicators with values below this threshold were retained.

The principles of indicator screening are as follows:

To evaluate the importance of the indicators, if none of the boundary values of the three statistics met the requirements, the indicators were deleted.

If an indicator has two aspects, importance, feasibility, or sensitivity, and each aspect has two or more boundary values that do not meet the requirements, then the indicator is deleted.

If all three boundary values for an indicator meet the requirements, the research group discusses the modification feedback from the experts and determines whether the indicator should be used.

The results of the two rounds of boundary values are shown in Table  1 .

Using the AHP to assign weights

After the second round of Delphi expert consultations, the analytic hierarchy process (AHP) was used to determine the weights of the two first-level indicators and the nine second-level indicators. The weights of the 37 third-level indicators were subsequently calculated via the percentage weight method. The AHP, developed by Saaty in the 1980s, is used to determine the priority and importance of elements constituting the decision-making hierarchy. It is based on multicriteria decision-making (MCDM) and determines the importance of decision-makers' judgments based on weights derived from pairwise comparisons between elements. In the AHP, pairwise comparisons are based on a comparative evaluation in which each element's weight in the lower tier is compared with that of other lower elements based on the element in the upper tier [ 18 ].

AHP analysis involves the following steps:

Step 1: Establish a final goal and list related elements to construct a hierarchy based on interrelated criteria.

Step 2: Perform a pairwise comparison for each layer to compare the weights of each element. Using a score from 1 to 9, which is the basic scale of the AHP, each pair is compared according to the expert’s judgment, and the importance is judged [ 19 , 20 ].

Yaahp software was employed to analyze data by creating a judgment matrix based on the experts' scores and hierarchical model. The index system weights were obtained by combining the experts' scores. The percentage weight method used experts' importance ratings from the second round to calculate weights, ranking indicators by importance, calculating their scores based on frequency of ranking, and determining weighting coefficients by dividing these scores by the total of all third-level indicators' scores. The third-level indicator weighting coefficients were then calculated by multiplying the coefficients [ 21 ].

Data analysis

Expert positivity coefficient.

The expert positivity coefficient is indicated by the effective recovery rate of the expert consultation questionnaire, which represents the level of expert positivity toward this consultation and determines the credibility and scientific validity of the questionnaire results. Generally, a questionnaire with an effective recovery rate of 70% is considered very good [ 22 ].

In this study, 20 questionnaires were distributed in both rounds of Delphi expert counseling, and all 20 were effectively recovered, resulting in a 100% effective recovery rate. Consequently, the experts provided positive feedback on the Delphi counseling.

Expert authority coefficient (CR)

The expert authority coefficient (Cr) is the arithmetic mean of the judgment coefficient (Ca) and the familiarity coefficient (Cs), namely, Cr =  \(\frac{({\text{Ca}}+{\text{Cs}})}{2}\) . The higher the degree of expert authority is, the greater the predictive accuracy of the indicator. A Cr ≥ 0.70 was considered to indicate an acceptable level of confidence [ 23 ]. Ca represents the basis on which the expert makes a judgment about the scenario in question, while Cs represents the expert's familiarity with the relevant problem [ 24 ].

Ca is calculated on the basis of experts' judgments of each indicator and the magnitude of its influence. In this study, experts used "practical experience (0.4), "theoretical analysis (0.3), "domestic and foreign peers (0.2)" and "intuition (0.1)" as the basis for judgment and assigned points according to the influence of each basis for judgment on the experts' judgment. Ca = 1 when the basis for judgment has a large influence on the experts, and Ca = 0.5 when the influence of the experts' judgment is at a medium level. When no influence on expert judgment was evident, Ca = 0 [ 25 ] (Table  2 ).

Cs refers to the degree to which the expert was familiar with the question. This study used the Likert scale method to score experts’ familiarity with the question on a scale ranging from 0 to 1 (1 = very familiar, 0.75 = more familiar, 0.5 = moderately familiar, 0.25 = less familiar, 0 = unfamiliar). The familiarity coefficient for each expert (the average familiarity for each indicator) was calculated. The average familiarity coefficient was subsequently computed [ 26 ].

The Cr value of the primary indicator in this study was 0.83, and the Cr value of the secondary indicator was 0.82 (> 0.7); hence, the results of the expert consultation were credible and accurate, as shown in Table  3 .

The degree of expert coordination is an important indicator used to judge the consistency among various experts regarding indicator scores. This study used the Kendall W coordination coefficient test to determine the degree of expert coordination. A higher Kendall W coefficient indicates a greater degree of expert coordination and greater consistency in expert opinion, and P  <  0.05 indicates that the difference is significant [ 26 ]. The results of the three-dimensional harmonization coefficient test for each indicator in the two rounds of the expert consultation questionnaire were valid ( p  <  0.01 ), emphasizing the consistency of the experts' scores. The values of the Kendall W coordination coefficients for both rounds are shown in Table  4 .

Basic information regarding the participants

The 20 Delphi experts who participated in this study were predominantly male (80.0%) rather than female (20.0%). In addition, the participants’ ages were mainly concentrated in the range of 41–50 years old (60.0%). The majority of the experts were doctors by profession (85.0%), and their education and titles were mainly doctoral degree (90.0%) and full senior level (17.0%). The experts also exhibited high academic achievement in their respective fields and had many years of working experience, with the majority having between 21 and 25 years of experience (40.0%) (Table  5 ).

Index screening

The boundary value method was applied to eliminate indicators, leading to the removal of 6 third-level indicators in the first round. One of these, the ability to use statistical software, was associated with a more significant second-level indicator involving data processing, which was kept after expert review. Six indicators were merged into three indicators due to duplication, and 5 third-level indicators were added, resulting in 2 primary indicators, 10 secondary indicators, and 43 third-level indicators.

In the second round of Delphi expert consultation, 5 third-level indicators were deleted, as shown in Additional file 3 , and only one third-level indicator, "Scientific spirit", remained under the secondary indicator "research attitude". The secondary indicator "Research attitude" was combined with "Research ethics" and the third-level indicator "Scientific spirit" was also considered part of "Research ethics". After expert discussion, these were merged into a new secondary indicator "Research attitude" with three third-level indicators: "Research ethics", "Research integrity", and "Scientific spirit". The final index system included two primary indicators, nine secondary indicators, and thirty-eight third-level indicators, as shown in Additional File 3 .

Final index system with weights

The weights of the two primary indexes, research literacy and research ability, were equal. This was determined using the hierarchical analysis method and the percentage weight method based on the results of the second round of Delphi expert consultation (Table  6 ). The primary indicator of research literacy encompasses the fundamental qualities and attitudes medical staff develop over time, including basic qualifications and approach to research. The primary indicator of research ability refers to medical professionals' capacity to conduct scientific research in new areas using suitable methods, as well as their skills needed for successful research using scientific methods.

In this study, the Delphi method was employed, and after two rounds of expert consultation, in accordance with the characteristics and scientific research requirements of medical staff in China, an index system for the scientific literacy of medical staff in China was constructed. The index system for medical staff's scientific literacy in this study consists of 2 first-level indicators, 9 second-level indicators, and 38 third-level indicators. Medical institutions at all levels can use this index system to scientifically assess medical staff's scientific literacy.

In 2014, the Joint Task Force for Clinical Trial Competency (JTF) published its Core Competency Framework [ 27 ]. The Framework focuses more on the capacity to conduct clinical research. These include principles such as clinical research and quality practices for drug clinical trials. However, this framework does not apply to the current evaluation of scientific literacy in hospitals. Because these indicators do not apply to all staff members, there is a lack of practical scientific research, such as information about the final paper output. Therefore, the experts who constructed the index system in this study came from different specialties, and the indicators can be better applied to scientific researchers in all fields. This approach not only addresses clinical researchers but also addresses the concerns of hospital managers, and the indicators are more applicable.

The weighted analysis showed that the primary indicators "research literacy" and "research ability" had the same weight (0.50) and were two important components of scientific literacy. Research ability is a direct reflection of scientific literacy and includes the ability to identify problems, the ability to use literature, professional capacity, subject implementation capacity, data-processing capacity, thesis-writing skills, and research output capacity. Only by mastering these skills can medical staff carry out scientific research activities more efficiently and smoothly. The ability to identify problems refers to the ability of medical staff to obtain insights into the frontiers of their discipline and to identify and ask insightful questions. Ratten claimed that only with keen insight and sufficient sensitivity to major scientific issues can we exploit the opportunities for innovation that may lead to breakthroughs [ 28 ]. Therefore, it is suggested that in the process of cultivating the scientific literacy of medical staff, the ability to identify problems, including divergent thinking, innovative sensitivity, and the ability to produce various solutions, should be improved. Furthermore, this study included three subentries of the secondary indicator "research attitude", namely, research ethics, research integrity, and scientific spirit. This is likely because improper scientific research behavior is still prevalent. A study conducted in the United States and Europe showed that the rate of scientific research misconduct was 2% [ 13 ]. A small survey conducted in Indian medical schools and hospitals revealed that 57% of the respondents knew that someone had modified or fabricated data for publication [ 28 ]. The weight of this index ranked first in the secondary indicators, indicating that scientific attitude is an important condition for improving research quality, relevance, and reliability. Countries and hospitals should develop, implement, and optimize policies and disciplinary measures to combat academic misconduct.

In addition, the third-level indicator "scheduling ability" under the second-level indicator "basic qualification" has a high weight, indicating that medical staff attach importance to management and distribution ability in the context of scientific research. Currently, hospitals face several problems, such as a shortage of medical personnel, excessive workload, and an increase in the number of management-related documents [ 29 , 30 ]. These factors result in time conflicts between daily responsibilities and scientific research tasks, thereby presenting significant obstacles to the allocation of sufficient time for scientific inquiry [ 31 ]. Effectively arranging clinical work and scientific research time is crucial to improving the overall efficiency of scientific research. In the earlier expert interviews, most medical staff believed that scientific research work must be combined with clinical work rather than focused only on scientific research. Having the ability to make overall arrangements is essential to solving these problems. The high weight given to the second-level index of 'subject implementation capacity', along with its associated third-level indicators, highlights the challenges faced by young medical staff in obtaining research subjects. Before implementing a project, researchers must thoroughly investigate, analyze, and compare various aspects of the research project, including its technical, economic, and engineering aspects. Moreover, potential financial and economic benefits, as well as social impacts, need to be predicted to determine the feasibility of the project and develop a research plan [ 32 ]. However, for most young medical staff in medical institutions, executing such a project can be challenging due to their limited scientific research experience [ 33 ]. A researcher who possesses these skills can truly carry out independent scientific research.

The weights of the second-level index "research output capacity" cannot be ignored. In Chinese hospitals, the ability to produce scientific research output plays a certain role in employees’ ability to obtain rewards such as high pay, and this ability is also used as a reference for performance appraisals [ 34 ]. The general scientific research performance evaluation includes the number of projects, scientific papers and monographs, scientific and technological achievements, and patents. In particular, the publication of papers is viewed as an indispensable aspect of performance appraisal by Chinese hospitals [ 35 ]. Specifically, scientific research papers are the carriers of scientific research achievements and academic research and thus constitute an important symbol of the level of medical development exhibited by medical research institutions; they are thus used as recognized and important indicators of scientific research output [ 36 ]. This situation is consistent with the weight evaluation results revealed by this study.

The results of this study are important for the training and management of the scientific research ability of medical personnel. First, the index system focuses not only on external characteristics such as scientific knowledge and skills but also on internal characteristics such as individual traits, motivation, and attitudes. Therefore, when building a research team and selecting and employing researchers, hospital managers can use the index system to comprehensively and systematically evaluate the situation of researchers, which is helpful for optimizing the allocation of a research team, learning from each other's strengths, and strengthening the strength of the research team. Second, this study integrates the content of existing research to obtain useful information through in-depth interviews with medical staff and constructs an evaluation index system based on Delphi expert consultation science, which comprehensively includes the evaluation of the whole process of scientific research activities. These findings can provide a basis for medical institutions to formulate scientific research training programs, help medical personnel master and improve scientific research knowledge and skills, and improve their working ability and quality. Moreover, the effectiveness of the training can also be evaluated according to the system.

In China, with the emergence of STEM rankings, hospitals pay more and more attention to the scientific research performance of medical personnel. Scientific literacy not only covers the abilities of medical personnel engaged in scientific research, but also reflects their professional quality in this field. Having high quality medical personnel often means that they have excellent scientific research ability, and their scientific research performance will naturally rise. In view of this,,medical institutions can define the meaning of third-level indicators and create Likert scales to survey medical staff. Based on the weights assigned to each indicator, comprehensive scores can be calculated to evaluate the level of scientific literacy among medical staff. Through detailed data analysis, they can not only reveal their shortcomings in scientific research ability and quality, but also provide a strong basis for subsequent training and promotion. Through targeted inspection, we can not only promote the comprehensive improvement of the ability of medical staff, but also promote the steady improvement of their scientific research performance, and inject new vitality into the scientific research cause of hospitals.

Limitations

This study has several limitations that need to be considered. First, the participants were only recruited from Beijing (a city in China), potentially lacking geographical diversity. We plan to select more outstanding experts from across the country to participate. Second, the index system may be more suitable for countries with medical systems similar to those of China. When applying this system in other countries, some modifications may be necessary based on the local context. Last, While this study has employed scientific methods to establish the indicator system, the index system has yet to be implemented on a large sample of medical staff. Therefore, the reliability and validity of the index system must be confirmed through further research. In conclusion, it is crucial to conduct further detailed exploration of the effectiveness and practical application of the index system in the future.

This study developed an evaluation index system using the Delphi method to assess the scientific literacy of medical staff in China. The system comprises two primary indicators, nine secondary indicators, and thirty-eight third-level indicators, with each index assigned a specific weight. The index system emphasizes the importance of both attitudes and abilities in the scientific research process for medical staff and incorporates more comprehensive evaluation indicators. In the current era of medical innovation, enhancing the scientific literacy of medical staff is crucial for enhancing the competitiveness of individuals, hospitals, and overall medical services in society. This evaluation index system is universally applicable and beneficial for countries with healthcare systems similar to those of China. This study can serve as a valuable reference for cultivating highly qualified and capable research personnel and enhancing the competitiveness of medical research.

Availability of data and materials

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

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Acknowledgements

The authors thank all who participated in the nominal group technique and two rounds of the Delphi study.

This study was supported by the National Natural Science Foundation of China (72074160) and the Natural Science Foundation Project of Beijing (9222004).

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Shuyu Liang and Ziyan Zhai contributed equally to this work and joint first authors.

Kai Meng and Yuan Gao contributed equally to this work and share corresponding author.

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Aerospace Center Hospital, No. 15 Yuquan Road, Haidian District, Beijing, 100049, China

Xiaozhi Sun, Jingxuan Jiao & Yuan Gao

School of Public Health, Capital Medical University, No.10 Xitoutiao, Youanmenwai Street, Fengtai District, Beijing, 100069, China

Shuyu Liang, Ziyan Zhai, Xingmiao Feng & Kai Meng

Beijing Tiantan Hospital, Capital Medical University, No. 119 South Fourth Ring West Road, Fengtai District, Beijing, 100070, China

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S.L. and Z.Z. contributed equally to this paper. S.L. took charge of the nominal group technique, data analysis, writing the first draft and revising the manuscript; Z.Z. was responsible for the Delphi survey, data analysis, and writing of the first draft of the manuscript; XF was responsible for the rigorous revision of Delphi methods; X.S. and J.J. were responsible for the questionnaire survey and data collection; Y.G. contributed to the questionnaire survey, organization of the nominal group interview, supervision, project administration and resources; and K.M. contributed to conceptualization, methodology, writing—review; editing, supervision, and project administration. All the authors read and approved the final manuscript.

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Correspondence to Yuan Gao or Kai Meng .

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Liang, S., Zhai, Z., Feng, X. et al. Development of an index system for the scientific literacy of medical staff: a modified Delphi study in China. BMC Med Educ 24 , 397 (2024). https://doi.org/10.1186/s12909-024-05350-0

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• Published: 10 April 2024

The impact of environmental regulation on green investment efficiency of thermal power enterprises in China-based on a three-stage exogenous variable model

• Fang-rong Ren 1 ,
• Tao-feng Wu 1 ,
• Yang-jun Ren 2 ,
• Xiao-yan Liu 1 &
• Xiaomei Yuan 3  

Scientific Reports volume  14 , Article number:  8400 ( 2024 ) Cite this article

Metrics details

• Energy and society
• Environmental economics
• Sustainability

Due to the increased frequency of extreme weather events and the implementation of the China’s dual-carbon target, thermal power companies have been under pressure to construct green infrastructure and to actively pursue low-carbon transformation in response to stricter environmental regulations. This research thus selects 30 listed thermal power enterprises in China as study objects and assesses their green investment efficiency in the low-carbon transition process using three-stage DEA evaluation model with environmental regulation as an exogenous variable. Based on this, a benchmark regression model is used to corroborate the relationship between environmental regulation and green investment. Simultaneously, we carry out analysis to compare the correlation between thermal power firms’ green investment efficiency and their focus on green investments. The results show in terms of total efficiency that environmental regulation significantly improves the total efficiency of 80% of thermal power enterprises compared to the absence of this exogenous variable. With the addition of environmental regulation, firms’ total efficiency declines gradually in general from 2018 to 2022, with the mean value of efficiency falling by 0.068. In terms of stage-specific efficiency, the efficiency of the green investment stage of the majority of firms is between 0.3 and 0.6, which is much lower than that of the operational stage and the market performance stage. In terms of sub-indicator efficiency, both green investment efficiency and social donation efficiency among thermal power enterprises show obvious polarization, with 30% of them having an efficiency of 1 and 30% less than 0.1. In terms of green investment focus, thermal power unit renovation has a more obvious role in boosting the green investment efficiency of thermal power enterprises than do wind power and photovoltaic projects. Therefore, both governmental departments and thermal power enterprises need to take active measures in order to achieve green transformation from the perspective of green investment efficiency. Through the segmentation of important projects of green investment, this paper provides a reasonable investment direction reference for the sustainable transformation of China’s thermal power industry. It also provides a rich and novel theoretical basis for the Chinese government to further improve the relevant environmental protection laws and regulations of thermal power industry.

Introduction

With environmental degradation and resource depletion becoming key impediments to global economic development, the green transformation of energy firms is on the horizon. According to the Energy Institute of the United Kingdom’s 2023 Statistical Yearbook of World Energy, worldwide energy demand increased by 1% in 2022. The historic increase of renewable energy has not altered the dominance of fossil fuels, which continue to supply 82% of global energy. Governments and other international organizations, such as the World Health Organization and the United Nations Environment Programme, have been actively encouraging research into environmental pollution and its effects on development in this respect. With coordinated efforts, the share of renewable energy in the world’s energy consumption from 2021 to 2022 would be 7.5%, or up around 1% from the year before. Indeed, 84% of the increase in net electricity consumption is met by a record 12% rise in wind and solar power generation.

Thermal power generation in China has accounted for 66.6% of total power generation in 2022, or growing 1.4% year on year. As a key energy supplier, thermal power firms must undergo green transformation in order to achieve sustainable development, and achieving this goal necessitates significant green investments. Global green investment increased from US$7 billion in 2000 to US$154 billion in 2010 1 , with the majority of that growth occurring in China. According to the United Nations Framework Convention on Climate Change (UNFCC), by 2050, $125 trillion in green investments will be needed to achieve carbon neutrality. According to the United Nations climate change annual report 2021, China is the largest contributor to green investment, particularly in the energy sector, valued at $266 billion. Among them, China's thermal power industry has also made large breakthroughs in the field of green investment. For example, according to the latest analysis of the China Electricity Council, the installed non-fossil energy generation capacity of the thermal power industry exceeded the size of the installed thermal power capacity for the first time in 2023, accounting for the first time for the proportion of the total installed capacity to exceed 50%.

To promote green investment, the China government has also continued to improve the environmental regulatory system by levying environmental protection taxes and opening up the carbon emissions trading market and green subsidy system. China is gradually forming a comprehensive environmental regulatory system combining command and control, market-led, and public participation 2 , 3 . According to the China Electricity Council, between 2016 and 2021 the power industry has already reduced carbon dioxide emissions by approximately 21.51 billion tons through non-fossil energy sources, reduced coal usage in power supply, and lower line-loss rate. China has now constructed the world’s largest ultra-low emission thermal power plant cluster.

As thermal power firms are critical to energy savings and emission reduction, green investment can help drive their sustainable development and also meet market and government requirements by enhancing energy cleanliness and low carbon. Thermal power companies typically boost their green investments in the early stages of tighter environmental rules in order to enhance their brand value and company image. However, because pollution control costs are rising and profit margins are narrowing due to stricter environmental restrictions, green investments have decreased rather than increased (Fig.  1 ). Therefore, it is necessary for this study to dig deeper into the reasons behind the phenomenon—that is, the trade-off between costs and benefits of green investment in thermal power enterprises as well as the relationship between enterprise green investment efficiency and the choice of green investment focus.

China’s thermal power industry annual green investment.

Summarizing the research conducted by scholars at home and abroad in this field, there are three main limitations. First, the analysis of existing research in this field mainly focuses on developed regions or areas, and lacks research on developing countries 1 , 4 . However, the impact of environmental regulation on green investment has a strong geographical nature, and the differences in policies across countries can lead to different implementation strengths of environmental regulation by local governments. Second, due to the difficulty of obtaining data on corporate green investment, scholars' studies on green investment have mainly focused on the national or city cluster level, and lacked analysis on the corporate level 5 , 6 . Even the studies on corporate green investment are too broad in terms of industries, ignoring the fact that the impact of environmental regulations on green investment is limited by industry attributes 3 , 7 . Third, most of the existing literature uses the amount of green investments made by firms or cities, which is rather one-sided 8 , 9 , 10 , 11 . The input–output indicator system constructed with multiple variables is more comprehensive to measure the efficiency of green investment.

Therefore, this study overcomes the above shortcomings with the following three main contributions. First, it considers that changes in both the ESG index and media attention affect the financial support received by enterprises, which in turn influences the size of the funds used by enterprises for green investment projects. Therefore, this study incorporates the enterprise ESG index and media attention into the index system for assessing the green investment efficiency of thermal power enterprises.

Second, there are fewer studies on the green investment efficiency of energy enterprises in developing countries, especially Chinese thermal power enterprises. This study analyzes the impact of environmental regulations on the green investment efficiency of Chinese thermal power enterprises in the context of the country’s social system, taking into account the reality of its economic development.

Third, other studies have analyzed the efficiency of green investment using mainly econometric models, which can only deal with a single efficiency assessment. This study adopts the DEA model, which is not only able to deal with multiple inputs and multiple outputs, but also avoids subjectivity due to the assignment of weights.

Literature review

Impact of green investment.

The literature on the impact of green investment of thermal power companies on their market value is divided into two main views: the promotion theory and the inhibition theory. Green investment is a form of resource allocation in thermal power companies, which can improve their environmental quality and corporate reputation by reducing the necessary investment in generating pollutants in their operations 1 . Taking listed energy companies in China as an example, some scholars have found that green investment improves their environmental performance through the reduction of environmental violations. This enhances the impact of green investment on the long-term market value of energy companies 12 . In addition, incorporating green investments into energy business strategy formulation helps reduce corporate environmental risks and prompts companies to create value in terms of social sustainability, ultimately leading to an increase in their market value 7 , 13 , 14 .

Some scholars have put forward opposite views on the impact of green investment on firm value, arguing that green investment has a negative or zero impact on firm performance. This is because green investment is relatively costly, takes away resources that companies use for normal production and operations, and usually requires a long payback period. Therefore, when enterprises conduct green investment operations, they incur a certain negative impact on cash flow and financial performance 15 . In short, green investment may have a certain inhibitory effect on the financial performance of enterprises. However, in the long term, green investments can help improve the environmental performance of energy companies, which in turn contributes to financial performance. Therefore, energy companies need to weigh inputs and outputs when making green investments as part of a long-term development strategy to achieve sustainable development.

Factors affecting green investment

The literature on green investment has a variety of research angles. Some scholars have studied the influencing factors and development trends of green investment in the energy industry in developed countries by using econometric models from the perspective of macroeconomics 5 , 9 . The results show that green investment is influenced by economic growth, interest rates, and fuel prices 1 . At the same time, policy intervention of the national government, such as an environmental tax burden, also has a positive impact on green investment 10 , 11 . In view of the impact of an environmental tax burden, some scholars have used a variety of advanced panel data methods to conduct more detailed research. The results show although taxes have a weak catalytic effect compared to other factors that well-structured environmental regulation can still significantly promote green investment by firms 6 . Therefore, governments can provide tax incentives for companies to undergo green innovation, so that companies can get help with innovative projects.

Some scholars have studied the relationship between corporate ESG ratings and green investment using linear mixed models. The results show that there is a positive correlation between green investment and corporate ESG ratings, which has a significant impact on corporate sustainable operations 8 . In addition, some studies start from the perspective of public attention. Through the use of panel data and econometric models, research has found that strict environmental regulations prompt enterprises to increase green investment 5 . Given the high energy intensity of countries in the Asia–Pacific region, some economists have examined the relationship between green investment and renewable energy deployment from a renewable energy perspective. Using Panel Pooled Mean Group (PMG) technique, the study found that green investment potential positively affects renewable energy deployment 16 . Finally, from the perspective of R&D and innovation, some scholars use multiple regression models to conduct empirical analyses, and the results show that environmental regulation, by increasing green investment, not only benefits green innovation in the region, but also contributes to the neighboring region's 17 .

No matter from which viewpoint, scholars’ analysis of green investment mainly focuses on the motivation, and the conclusions are controversial. Therefore, the reasons for the dispute need to be further analyzed. Moreover, research has mainly focused on the green investment of enterprises, lacking any analysis and evaluation on green investment efficiency.

Influence of environmental regulation on green investments

As an important means to coordinate social development and environmental protection, environmental regulation has played an important role in environmental governance in recent years by effectively guiding the environmental behavior of enterprises and individuals. Studies mainly measure environmental regulation by the cost of pollution control, capital expenditure on pollution reduction 18 , pollutant discharge 19 , environmental tax burden 6 , 20 , 21 , and so on. Based on the differences in the above measurement standards, the impact of environmental regulations on green investment can be divided into three perspectives.

Traditional economists have argued that environmental regulations inhibit firms' green investments. They believe that environmental regulation inhibits firms' green investment. This group of scholars argues that environmental regulation can inhibit green investment by imposing unnecessary costs on firms and having a crowding-out effect on investment in innovation, which reduces the productivity of firms 22 , 23 , 24 . However, some scholars, led by Porter, have challenged that view. Porter believes that environmental regulation can bring “innovation compensation effect”, which is conducive to the realization of the enterprise's environmental performance and economic performance of the joint improvement 25 . Therefore, this group of economists point out that environmental regulation will stimulate enterprises to break the inherent business model and product structure, and put pressure on enterprises to consider environmental issues, so as to realize energy saving and emission reduction 26 , 27 . In addition, a small number of scholars, based on the “factor endowment hypothesis”, believes in a non-linear relationship between environmental regulation and corporate green investment.

No matter using regression analysis or the SBM-DDF model, studies have shown an inverted U-type non-linear relationship between environmental regulation and corporate green investment 3 , 28 . In the early stage of strengthening environmental regulations, enterprises increase green investment and change production methods due to legal requirements. However, with increasing environmental regulation, there will be an inflection point in the factor endowment advantage, when the costs of green investment outweigh the benefits of complying with environmental regulations. This is also contrary to the Poter hypothesis, where high pollution control costs lead to "crowding out" of R&D investment 29 , and firms prefer to accept penalties for non-compliance rather than make more green investments.

Most of the literature acknowledges the significant impact of environmental regulation on enterprises’ green investment, but due to differences in indicators and methods adopted by each research institute, the conclusions are inconsistent. A higher level of environmental tax burden closely relates to strict environmental regulations 30 . As an economic means, an environmental tax burden can regulate the environmental behavior of thermal power enterprises by directly affecting their production and operation. Therefore, this study uses environmental tax burden to measure environmental regulation and studies its impact on the green investment efficiency of China’s thermal power enterprises. Doing so provides a theoretical basis for the government to formulate relevant policies for the sustainable development of thermal power enterprises.

• Green investment efficiency

As green investment efficiency has gradually become a crucial factor affecting the sustainable development of energy enterprises, empirical research based on DEA theory has also been widely used by scholars. Some scholars have analyzed the relationship between enterprise green investment and performance by the DEA method and panel vector autoregression method (VAR). Findings show that enterprises’ green investment inhibits productivity improvement 31 . From the perspective of environmental regulation, some scholars have introduced the learning curve theory into the traditional DEA model to describe the dynamic changes of power enterprises under different policy scenarios. The results show an interactive relationship between environmental regulation, environmental protection investment, and the sustainable development of power enterprises 32 . Environmental regulation motivates enterprises to pay attention to environmental performance, thus improving the efficiency of their green investment 33 .

Some scholars hold a different view, with some quantifying the green investment efficiency of heavy polluting enterprises through the SBM-DEA model. The results show an inverted U-shape non-linear relationship between environmental regulation and green investment efficiency of Chinese polluting enterprises 34 . Some scholars have also utilized the Tobit model and found a double effect of environmental regulation on the green efficiency of thermal power enterprises. It is specifically manifested as a U-shape non-linear relationship of first inhibition and then promotion 35 . Therefore, local governments must pay attention to the differentiation of environmental regulations in order to encourage energy enterprises to improve green investment efficiency.

From the perspective of digital empowerment, some scholars have used the SBM-DEA method to conduct quantitative analysis of the green investment efficiency of heavy polluting enterprises. Research has found that digital empowerment promotes green efficiency through increased analyst attention and greater R&D investment 36 .

In short, the green investment efficiency evaluation method based on DEA has wide application prospects in the current global low-carbon environmental protection era. These theories also provide a theoretical basis for government departments to guide the environmental management of energy enterprises.

Although there is a growing body of literature on the relationship between environmental regulation, green investment efficiency, and firm performance, there are still some limitations in this research field. In fact, most studies admit under strict environmental regulations that green investment of enterprises positively impacts their performance. However, the existing studies on the relationship between green investment and environmental regulation are relatively broad, mostly focusing on city clusters or all enterprises, and rarely focusing on a particular industry, especially the thermal power industry. As a result, the conclusions and policy recommendations are not fully applicable to all industries, and it is difficult for the government to improve environmental policies accordingly. In addition, the existing literature on green investment at the enterprise level is mainly limited to econometric methods, and there is less literature on the use of DEA models to study the efficiency of green investment in energy enterprises.

Research method

Based on the fact that the evaluation performance of the DDF non-ray distance function is better and provides more accurate estimation results, this study amends the traditional DDF model, combines the dynamic DEA model of Tone and Tsutsui 37 , and considers the exogenous problem, so as to solve the deficiencies of one-, two-, and three-stage Dynamic DDF under an exogenous DEA model. The formula runs as follows.

Assume that a decision-making unit ( \({DMU}_{j},j=1,\dots ,J\) ) has \(t (t=1,\dots ,T)\) time periods. Within each time period there are three stages: Stage 1, Stage 2, and Stage 3.

In the first stage, there are D inputs \({x}_{ij}^{t}\left(i=1,\dots ,m\right)\) that produce P intermediate products \({z}_{Pj}^{t}\left(p=1,\dots ,P\right)\) and Q desired outputs \({o}_{qj}^{t}\left(q=1,\dots ,Q\right)\) .

The second stage uses P intermediate products \({z}_{Pj}^{t}\left(p=1,\dots ,P\right)\) and F inputs \({a}_{fj}^{t}\left(f=1,\dots ,F\right)\) to create R desired outputs \({y}_{rj}^{t}\left(r=1,\dots ,R\right)\) and S intermediate products \({u}_{sj}^{t}\left(s=1,\dots ,S\right)\) .

The third stage uses S intermediate products \({u}_{sj}^{t}\left(s=1,\dots ,S\right)\) and G inputs \({f}_{gj}^{t}\left(g=1,\dots ,G\right)\) to create L desired outputs \({n}_{lj}^{t}\left(l=1,\dots ,L\right)\) .

Stage 1 (operation stage) inputs are number of employees and thermal power installed capacity. Output is operating revenue. Stage 1 links to Stage 2 via R&D expenses.

Stage 2 (green investment stage) inputs are green investment, proportion of installed renewable energy capacity, and social donation. Output is the ESG index. Stage 2 links to stage 3 via media attention.

Stage 3 (market performance stage) input is operating costs. Outputs are enterprise market value and market share. Exogenous variable \(={A}_{vj}\left(v=1\dots V\right)\) is environmental regulation, and carry-over \({= c}_{hj}^{t}\left(h=1,\dots ,H\right)\) is fixed assets.

Here, \(j\) represents the number of each DMU, i.e., the 30 thermal power enterprises in this paper, \(t\) represents the stage, and \(i,p,q,f,r,s,g,v,h,l\) represent the order of each variable. For example, \({x}_{ij}^{t}\) stands for the i ’th input of enterprise \(j\) in stage \(t\) .

Objective function

If there is an n dimension \(DMU\) set denoted as j , where \({DMU}_{o}\) represents the \(DMU\) under evaluation and \({DMU}_{o}\in j,\) then the mathematical model is formulated as follows.

Formula ( 1 ) calculates the efficiency of \({DMU}_{o}\) . Of these, formula ( 1 ) is primarily referenced to Chiu et al 38 .

If there is an n dimension \(DMU\) set denoted as \(j\) , where \({DMU}_{o}\) represents the \(DMU\) under evaluation and \({DMU}_{o}\in j.\)

Here, GFE represents Global-Factor Efficiency. \({\gamma }_{t}\) is the weight assigned to period t, and \({w}_{1}^{t}\) , \({w}_{2}^{t}\) , and \({w}_{3}^{t}\) are the weights assigned to Stage 1 efficiency, Stage 2 efficiency, and Stage 3 efficiency, respectively. Therefore, \({w}_{1}^{t}\) , \({w}_{2}^{t}\) , and \({w}_{3}^{t}\) and \(\sum_{t=1}^{T}{\gamma }_{t}=1\) .

Exogenous variable and links of stages

The exogenous variable is formula ( 2 ). Of these, formula ( 2 ) is primarily referenced to Li et al 39 .

Here, \( \lambda_{j}^{t} ,\;\mu_{j}^{t} ,\;\rho_{j}^{t}\) denote the weights of the benchmarking for \({DMU}_{o}\) in the first, second and three stages, respectively.

Stage 1 and Stage 2 links are formula ( 3 ). Stage 2 and Stage 3 links are formula ( 4 ). The two periods of links are formula ( 5 ). Of these, formula ( 3 ), (4), (5) is primarily referenced to Lu et al 40 .

Overall efficiency, period efficiency, stage efficiency, and period stage efficiency can be obtained from the above results.

Sub-efficiency values

The sub-efficiency values of the variables in this study are calculated in accordance with the Total-Factor Efficiency (TFE) indicator published by Hu and Wang 41 via the following equation.

Input variables and good output variables are formulae (6) and (7), respectively.

If the value of total factor efficiency is 1, then the efficiency target has been achieved; conversely, it means that there is an excess of inputs or a shortage of outputs, indicating that there is room for improvement.

Empirical analysis

Data description.

This paper selects data from 30 listed thermal power companies in China from 2018 to 2022. The selection is based on thermal power listed companies that are ranked among the top 30 in market capitalization on the Flush Financial Data Platform as of the end of 2022 and have been listed for more than five years. The abbreviations of the sample companies are in “ Appendix A ”. Since the green investment path of listed thermal power companies is not unique, different companies illustrate differentiated transformation by combining their own advantages.

Studies vary in their division of green investments. According to the green financial products invested, they can be divided into green credit, green securities, and green insurance 42 . According to the use of green investment project funds, they can be divided into expenditures for environmental pollution control and expenditures for environmental infrastructure construction 43 . As the research object of this paper is thermal power listed enterprises, power generation projects are the key aspects of their main business and green investments. Therefore, this paper classifies the green investments of enterprises into three types according to the energy type of the project by analyzing the important ongoing projects of thermal power enterprises: the transformation of thermal power units, photovoltaic projects and wind power projects (Table 1 ).

A new energy project is a national key support project that can effectively reduce the carbon emissions of enterprises. From the viewpoint of power generation cost, the cost of photovoltaic power generation has been reduced to parity and even lower than the cost of thermal power. From the viewpoint of geographical adaptability, wind power projects can be built in cities, suburbs, villages, and coastal areas with strong geographical adaptability. However, the instability of a wind project determines that thermal power units need to be used as a peaking power source to ensure stable operation of the grid. A new energy project construction cycle is longer, and it is difficult to achieve results in the short term. Therefore, thermal power companies still carry out thermal power unit renovation to maintain their stable operation.

Among the enterprises in the sample of this study, there are 25, 18, and 11 carrying out thermal power unit renovation, Photovoltaic projects, and wind power projects, respectively. There are 5 enterprises carrying out all three types of projects at the same time. Finally, 13 enterprises carry out both types of projects at the same time.

This study evaluates the number of employees, installed thermal power capacity, operating revenue, R&D expenses, green investment, proportion of installed renewable energy capacity, social donations, ESG index, media attention, operating costs, enterprise market value, market share, fixed assets, and environmental regulation of the sample companies from 2018 to 2022. Among them, Min–Max normalization is performed on the raw data of the proportion of installed renewable energy capacity and market share. The research framework based on the three-stage parallel DEA model with relevant indicators is given in Fig.  2 .

Research framework based on three-stage parallel DEA modeling.

The main design ideas of the three-stage DEA model in this paper are as follows. First, the process of assessing the green investment efficiency of thermal power enterprises is divided into operation stage (Stage 1), green investment stage (Stage 2), and market performance stage (Stage 3). The first stage is operation. Thermal power enterprises through the normal operation and profitability in this stage lay a good foundation for subsequent green investment. Thermal power installed capacity and the number of employees is mainly selected as inputs, and operating revenue and R&D expenses are outputs. The R&D expenses are continuously invested into the second stage as supportive funds for green investment.

Second, the second stage is green investment. Green investment, the proportion of installed renewable energy capacity, and social donations are taken as inputs. The ESG index and media attention are taken as outputs.

Finally, the third stage is market performance. Media attention is used as an input in the third stage to characterize its important role in a firm’s market performance. Operating costs are an input. Market value and market share are outputs. The T and T + 1 stages are connected through the carry-over variable of fixed assets. Table 2 below specifically explains each indicator.

Descriptive statistics

Due to space limitation, only major variables are selected for statistical description in this paper. Green investment stage is a key turning point for thermal power enterprises to achieve sustainable development and plays an important role in the steady operation of enterprises. Therefore, the selected indicators are categorized into two types for statistical description herein: operation and market indicators and sustainability indicators. Their mean, maximum, and standard deviation are calculated respectively, and the results are rounded to two decimal places. Figures  3 and 4 show the statistical description of the two categories of variables by year.

( a – d ) Descriptive statistics of operating and marketability variables.

( a – d ) Descriptive statistics of sustainability variables.

In terms of the operation and market performance of thermal power enterprises, their installed capacity (Fig.  3 a) has been relatively stable in recent years. R&D expenses (Fig.  3 b) have increased year by year, and the growth rate is also increasing year by year. By raising R&D expenses, thermal power enterprises can carry out technological innovation to develop new products or new energy technologies, thus improving their production and operational efficiency. In addition, although the market value of enterprises (Fig.  3 c) has obvious fluctuations, the market share (Fig.  3 d) is generally stable and does not show large changes.

Looking at the sustainability of thermal power firms, first, social donation (Fig.  4 a) is far more volatile than the other variables, with 2019 leading the five-year period in terms of this factor. Second, green investment (Fig.  4 b), which had been trending upward in the previous four years, suddenly declined in 2022, possibly due to increased environmental regulations. Finally, the steady growth trend in the proportion of installed renewable energy capacity (Fig.  4 c) and the high level of the ESG index (Fig.  4 d) reflect that companies are actively pursuing a green and low-carbon transition.

Empirical result analysis

Total efficiency analysis.

This study considers the inclusion of exogenous variables and the absence of exogenous variables separately when assessing each DMU. According to the empirical results of this paper, after adding exogenous variables, the green investment efficiencies of 24 out of 30 firms significantly improve. Without considering exogenous factors, the average value of the overall efficiency of enterprises is 0.553, and 10 enterprises have total efficiency greater than 0.6. After considering exogenous factors, the mean value of overall efficiency is 0.591, and 13 thermal power enterprises have total efficiency greater than 0.6. Obviously, environmental regulation as an exogenous variable in the model significantly improves the underestimation of enterprises’ green investment efficiency.

As can be seen from Fig.  5 , the green investment efficiency of thermal power enterprises was at its lowest in 2019 at 0.501 and hit its peak in 2021 at 0.590. The overall trend is that it first declines, then improves, and finally declines again. In 2018–2019, at the beginning of the strengthening of environmental regulations, the increased cost of thermal power enterprises for pollution control had a crowding out effect on innovation investment. This also led to a decline in the green investment efficiency of thermal power enterprises, from 0.553 to 0.501. With the implementation of environmental policies, enterprises are forced to develop cleaner and more environmentally friendly production methods due to pressure from the environmental tax burden. For example, the renovation of thermal power units and the development of new energy projects spurred the green investment efficiency of enterprises to increase by 8.9% in two years. However, as the proportion of new energy connected to the grid increases, the power system is not flexible enough, and the problem of consumption gradually emerges. The green investment efficiency of enterprises thus exhibits a significant decrease.

Average green investment efficiency (2018–2022).

Of the 24 thermal power companies that have improved after adhering to the environmental regulation, 18 companies are carrying out retrofitting of thermal power units and 15 are carrying out photovoltaic projects. Relatively fewer firms, less than half, are targeting the construction of wind power projects. Among the top 10 enterprises with the strongest improvement effect, 80% of them have carried out thermal power unit renovation. Obviously, enterprises prefer to realize the improvement of their green investment efficiency by retrofitting thermal power units. On the one hand, retrofitting thermal power units is flexible and has a low cost compared to new energy construction. Thermal power units can operate stably for a long period of time and adjust their output according to power demand. On the other hand, photovoltaic projects and wind power projects have strong volatility, homogeneity and require flexible resource packages to solve the consumption problem. In the case of a significant increase in electricity load, wind and solar clean resources are difficult to provide enough controllable power.

In China there are still provinces with a significant problem of abandoned wind or abandoned light. They include Inner Mongolia, Qinghai, Gansu, and other wind power provinces. Some areas of wind power or photovoltaic power only have a utilization rate of 90%. Therefore, compared with Photovoltaic projects and wind power projects, companies can more feasibly improve their total efficiency through the renovation of thermal power units.

By comparing the green investment efficiency of the top 5 and bottom 5 thermal power enterprises, this paper finds that efficiency significantly improves after considering exogenous variables. As seen from Fig.  6 , the green investment efficiency value of each thermal power enterprise varies greatly. Among them, DHEP has the lowest green investment efficiency value of 0.341, which is only 1% higher than the case without considering environmental regulation. DLPC has the highest efficiency value of 0.960, which is an increase of nearly 10% over the case without taking into account exogenous factors. The improvement is significant. Therefore, the impact of environmental regulations on DLPC is much greater than that on DHEP. This may be due to the fact that DHEP is higher than DLPC in terms of enterprise size, capital cost, and technical feasibility. Its investment in green innovation has already reached a high level, and so the improvement rate is not as high as DLPC. In addition, DHEP’s fuel costs increased by U$$2.953 billion year-over-year in 2021 due to the increase in the unit price of standard coal used for power generation. The significant increase in operating costs leads to a company’s lower gross margin and continued losses. In turn, the focus on green investments continues to diminish, and the efficiency of green investments is bound to decrease.

Total efficiency values of thermal power enterprises (top and bottom 5). Notes : The ranking is based on the efficiency value after adding exogenous variables. S means considering exogenous variables. S* means not considering exogenous variables.

In terms of the magnitude of improvement, the impact of environmental regulation on GDGI ranks first among the sample firms, with a 20.8% improvement in green investment efficiency. On the one hand, GDGI's earnings continue to be high, and there is enough capital to build on green investments. On the other hand, environmental regulations have been strengthened, and significant results have been achieved in green investments. Therefore, a company can decide to continue to invest in green investments in the future and continue to invest in research and development. From thermal power generation to multiple energy sources, GDGI has always adhered to the direction of clean energy development. The improvement of its green investment efficiency is also an inevitable trend.

In conclusion, environmental regulations have a more significant impact on the green investment efficiency of Chinese thermal power companies. During the period from 2018 to 2022, the average value of the environmental tax burden paid by enterprises is generally increasing. Environmental regulations force thermal power enterprises to improve their production and operation methods by increasing their environmental management costs. Moreover, thermal power enterprises combine their own advantages to carry out green transformation of industrial structure. While realizing green and high-quality development, they also promote the improvement of green investment efficiency.

Stage efficiency analysis

Efficiency analysis of operation stage (stage 1).

In the operation stage, this study includes the number of employees, installed thermal power capacity, and operating revenue in the input–output index system of this stage. According to the empirical results of this paper, during the period from 2018 to 2022 the efficiency of thermal power enterprises in the operation stage performs well with an overall mean value of 0.613. However, there are still some enterprises with low efficiency in this stage, such as DTPC, whose efficiency value fluctuates around 0.2 or less than one-third of the average value.

As seen from Fig.  7 , the inclusion of environmental regulation can significantly increase the efficiency of thermal power enterprises in the operation stage. The collection of environmental taxes raises the production costs of highly polluting enterprises, thus promoting the optimal allocation of resources and industrial restructuring. For thermal power enterprises, the collection of environmental taxes pushes them to pay more attention to the development of clean energy and to increase investment in renewable energy. By optimizing the industrial structure, the energy efficiency of thermal power enterprises will improve. In response to the role of exogenous variables in this stage, BNEC is most strongly affected, mainly because BNEC is driven by environmental regulations and focuses on the level of cost optimization and energy savings. It is a commitment to operational efficiency improvement whose improvement effect is as high as 0.462 in 2019.

Average value of efficiency in operation stage (2018–2022). Notes : Stage1 means considering exogenous variables. Stage1* means not considering exogenous variables.

After 2020 in the late period of strengthening environmental regulations, the operational efficiency of thermal power enterprises has significantly weakened. The average efficiency fell by 14.5% in two years, perhaps due to the need for thermal power companies to invest more resources and funds in technology upgrades in order to meet more stringent environmental requirements. Therefore, for improving energy efficiency and reducing pollutant emissions, there will be some technical or economic restrictions that result in the decline of efficiency at this stage. In summary, environmental regulations can, to some extent, lead to higher efficiency values by inducing improvements in energy use efficiency and reductions in pollutant emissions during the operational stage of an enterprise. However, with increased pressure on profitability, thermal power companies may encounter some constraints in this regard, leading to a slowdown or decline in the rate of improvement of efficiency values.

Efficiency analysis of green investment stage (Stage 2)

The green investment stage is an indispensable part of thermal power enterprises to realize sustainable development. This study includes green investment, the proportion of installed renewable energy capacity, social donations, and the ESG index into the input–output index system of this stage. Table 3 shows the efficiency value of green investment stage of thermal power enterprises selected by this paper with more typical performance in this stage.

The inclusion of environmental regulations has somewhat increased the efficiency value of the green investment stage of thermal power companies during the period from 2018 to 2022. This may be due to the fact that environmental regulation incentivizes firms to approach the green investment business in a more prudent and proactive manner, which in turn promotes green investment efficiency. However, nearly one-third of the thermal power firms, such as HDEC and TFEC (Table 3 ), have reached the optimal efficiency value before the addition of the exogenous variables, and thus there is no significant improvement.

With the increase of environmental regulation pressure, the efficiency value of thermal power companies in the green investment stage shows a large decline. It falls from 0.566 in 2018 to 0.307 in 2022 or a drop of 25.9% (Fig.  8 ). Even though there is a slight rebound during the period, it again shows a more substantial fall in the following year. This is mainly due to the thermal power enterprises in the process of accelerating the development and utilization of clean energy illustrating that new energy generation will have difficulties in sending out and consuming. The wind turbines and photovoltaic equipment in many areas have been left idle for a long time.

Average efficiency of green investment stage (2018–2022). Notes : Stage2 means considering exogenous variables. Stage2* means not considering exogenous variables.

The phenomenon of abandoning light and wind is serious. Moreover, supply chain issues and downward economic pressure due to COVID-19 could have also hindered green investments by thermal power companies between 2021 and 2022. However, some companies have bucked the trend. For example, GEPC’s green investment stage efficiency grew from 0.047 to 0.112, or an improvement of nearly three times.

Compared with the other two stages, the green investment stage has the lowest average efficiency value, between 0.3 and 0.6, and the largest difference in efficiency between enterprises. This is reflected in the serious bifurcation of the efficiency values of the sample enterprises in this stage. The difference between high-efficiency and low-efficiency enterprises is even close to 100%, which is also directly linked to the green investment focus of thermal power companies. Retrofitting thermal power units not only has greater potential and lower investment costs, but also smoothes out the impact of new energy power on the grid.

Thermal power units have a stronger role in improving the efficiency of the green investment stage. For example, JGCL’s green investment projects during this five-year period were dominated by the renovation of thermal power units and supplemented by the construction of new energy projects (Table 3 ). Thus, JGCL has always maintained a high level of efficiency in the green investment stage. By contrast, HDPC focuses on the construction of new energy projects, such as photovoltaic projects and wind power projects. Therefore, its efficiency in this stage is lower (Table 3 ).

Efficiency analysis of market performance stage (Stage 3)

Thermal power firms have the highest efficiency values in the market performance stage compared to the efficiency values in the other two stages. There is also not much difference in the efficiency values among the firms. Except for a few firms such as JNPC, NMHD, and SNPC, most of the other firms have efficiency values fluctuating around 0.7 in this stage. At this stage, the inclusion of environmental regulations had a relatively small effect on improving efficiency, with most firms improving by less than 5%. Overall, the market performance stage efficiency increased year-on-year with the strengthening of environmental regulations and rose much higher than the operational stage (Fig.  9 ). The unusual performance in 2018 was due to the multiple adjustments in the domestic refined petroleum product market along with the increase in coal prices during the year. They had a dampening effect on the efficiency of most thermal power companies, especially JGCL, in the market performance stage.

Average efficiency of market performance stage (2018–2022). Notes : Stage3 means considering exogenous variables. Stage3* means not considering exogenous variables.

The collection of environmental taxes will prompt thermal power enterprises to increase their investment in and development of clean energy. Thus, it will guide enterprises toward restructuring, transformation, and upgrading. For example, GDGI has not only raised its R&D investment year by year, but also continued to increase mergers and acquisitions of high-quality assets and clean energy to optimize its industrial layout.

There are some firms that are not sensitive to environmental regulation. For example, DTPC and HNPC, whose efficiency values in the market performance stage did not improve more significantly from the environmental tax burden (Table 4 ). The pressure of environmental regulations burden increases the cost of highly polluting and inefficient thermal power firms. For firms adopting clean energy and high efficiency technologies, their costs will be relatively lower. This leads to the exit of inefficient thermal power firms from the market. In turn, high-efficiency firms have the opportunity to expand their market share and increase their efficiency value in the market performance stage.

Sub-index efficiency analysis

Due to space limitations, only the main indicators are selected for sub-indicator efficiency analysis in this paper. Table 5 reflects the average values of the efficiency of the main indicators of Chinese thermal power enterprises from 2018 to 2022 with and without considering exogenous variables.

First, the efficiency of installed thermal power capacity directly affects the power generation capacity and capacity level of the enterprise. Hence, it is an important factor for thermal power enterprises to maintain normal business management. After considering the exogenous variable of environmental regulation, the average value of thermal power firms’ installed capacity efficiency increases in most years and peaks at 0.730 in 2020 (Table 5 ). A few firms are insensitive to the role of environmental regulation, such as JKPC and JNPC. Most companies show a very clustered thermal power installed capacity efficiency of 0.5 or more from 2018 to 2022. For highly polluting and inefficient thermal power units, environmental regulation will increase the operating costs of thermal power enterprises. Therefore, companies will actively adopt energy saving and emission reduction measures and emphasize technological innovation, such as vigorously renovating thermal power units and developing clean energy projects. For example, SNCL has invested in a number of hydrogen energy projects, driven by environmental regulation.

Second, enterprises’ market value efficiency stays at a high level from 2018 to 2021, yet declines substantially in 2022, as in the case of AHWC and GEPC. The inclusion of environmental regulations improves the average market value efficiency of thermal power firms in all years except 2022. In particular, in 2018 the average market value efficiency improves by as much as 15.9%. Environmental regulations can incentivize firms to adopt more environmental protection measures to reduce pollutant emissions, such as ultra-low emissions and desulfurization and denitrification technologies. However, in the late stage of environmental regulation strengthening, the obstruction of new energy construction and excessive cost burden can inhibit the market value efficiency of enterprises. Their average value of efficiency decreases by two-thirds from 0.931 in 2018 to 0.619 in 2022 (Table 5 ). For example, in 2018 to 2021, DTPC and DLPC have reached the optimal point of their enterprises’ market value indicator efficiency in yearly increments under the pressure of the environmental regulation. In 2022, however, excessive cost burdens led to a significant decline in firm market efficiency, or far less than half of what it was in 2021.

Third, with the strengthening of environmental regulations, the average green investment efficiency value of thermal power enterprises has been declining in fluctuation over the five-year period. The average green investment efficiency value is the highest in 2018 at 0.595, while 2022 has the lowest efficiency at 0.274 or less than half of that in 2018 (Table 5 ). Green investment efficiency rebounds considerably in 2021, but then deteriorates sharply in the following year, going from 54.2 to 27.4%. SEPC and GDGI have seen a typical plunge in the efficiency of their green investments, with a decline of almost 100%. This is mainly due to the fact that companies pay more attention to compliance in order to avoid being fined or facing other legal risks. This ultimately results in companies not being able to fully utilize the benefits of green investment.

After adding exogenous variables, the average green investment efficiency of the 30 thermal power companies has improved in the previous four years. Especially for BNEC, the addition of environmental regulation directly doubles its efficiency value several times to reach optimal efficiency. During this period, the average social donation efficiency value has fluctuated slightly, but overall, it is still slowly decreasing. The average social donation efficiency value in 2018 ranked first among the five years at 0.520 (Table 5 ). It is worth noting that both green investment efficiency and social donation efficiency of thermal power enterprises are bifurcated. High-efficiency enterprises, such as DLPC and HDEC, achieve an optimal efficiency of 1 for both green investment efficiency and social donation efficiency. However, more than half of the enterprises have both efficiencies of almost 0. This phenomenon may relate more to the enterprises’ view of social responsibility and their own operation situation.

Finally, the ESG index efficiency of most thermal power companies is decreasing year by year, from 0.907 to 0.486. This is mainly due to the fact that companies will reduce the financial pressure from an environmental tax burden by lowering environmental protection investment, which leads to the inability to fully utilize the benefits of ESG index efficiency. In the first two years, the inclusion of exogenous variables can improve the average ESG index efficiency of thermal power enterprises. However, in the latter three years, environmental regulation shows an inhibitory effect on it, and the inhibitory impact increases year by year. In 2022 the inhibitory effect of environmental regulations on the ESG index efficiency of thermal power companies hit 22.8%. This causes the average ESG index efficiency of firms to fall from 0.714 to 0.486 (Table 5 ). However, there are also firms that show an abnormal rise. For example, CEPC’s ESG index efficiency has been positively affected by environmental regulation with a small increase in efficiency values.

Regression analysis

where i denotes the individual company, t denotes the year, \({Green investment}_{it}\) denotes the amount of green investment of the thermal power enterprise, \({Environmental\; regulation}_{it}\) denotes the environmental tax burden paid by the thermal power enterprise, \({\gamma }_{t}\) denotes the time fixed effect, and \({\varepsilon }_{it}\) is the random perturbation term.

In order to further verify the impact of environmental regulation on green investment, this paper carries out a benchmark regression for formula ( 8 ). The regression results show that environmental regulation is significantly positive at the 1% level, indicating that environmental regulation can promote the green investment of thermal power enterprises. On the one hand, under the pressure of environmental regulation, thermal power enterprises will actively make green investment for tax incentives. On the other hand, environmental regulation will increase the cost pressure on thermal power enterprises, which will encourage them to make green investment to reduce their pollutant emissions. This result further confirms the accuracy of the above DEA model evaluation (Table 6 ).

Conclusions and suggestions

The above analysis shows that environmental regulation improves the green investment efficiency of thermal power enterprises. This is similar to the view of some scholars 26 , 27 , 33 , 44 . Environmental regulation improves the green investment efficiency of enterprises by encouraging them to use low-carbon technologies, which have a positive effect in promoting the sustainable development of enterprises. Some studies have also suggested that the relationship between environmental regulation and green investment is nonlinear 45 , 46 , 47 , mainly because the relationship is affected by industry and regional differences. Most thermal power enterprises are polluting enterprises, which are more sensitive to the role of environmental regulation and also bear a higher degree of pressure to spend on environmental protection compared to their own environmental pollution.

With the continuous strengthening of environmental regulation, the green investment efficiency of thermal power enterprises will gradually decrease. This is slightly different from some of the scholars’ research on heavily polluting enterprises 4 , 34 , 48 . It may be due to the fact that our study just selects the relevant data of thermal power enterprises within 5 years. Only some of the old power plants in thermal power enterprises are heavy polluters, and so there is some difference for the future trend of green investment efficiency.

Although the results of this study show a correlation between the green investment focus of thermal power enterprises and their green investment efficiency, there may still be some errors. Future research should explore the specific reasons for the changes in green investment efficiency in depth, taking into account the geographical location of thermal power enterprises and the impact of the policy environment. This will provide a more comprehensive analysis for the literature on green investment efficiency.

Conclusions

This paper draws the following conclusions by evaluating the operational, green investment and market performance efficiencies of 30 listed thermal power companies from 2018 to 2022, and regressing environmental regulation on green investment.

In terms of total efficiency, 80% of the sample firms show a significant improvement in total efficiency with the addition of environmental regulations compared to without exogenous variables. Among them, the improvement of GDGI is the most prominent. The addition of environmental regulations can force high-polluting enterprises to emphasize green innovation through the R&D mechanism, which turn plays a positive role in promoting the total efficiency of thermal power enterprises. However, with the addition of environmental regulations, the total efficiency of thermal power firms exhibits a slight decreasing trend between 2018 and 2022. This is associated with cost pressures on firms and the long-term nature of the reduction in green investments.

In terms of stage-specific efficiency, more than 60% of thermal power firms’ green investment stages are less efficient as a result of stronger environmental regulations. Compared with the operation and market performance stages, the green investment stage has the lowest efficiency at an overall average value between 0.3 and 0.6. This suggests that the green investment stage is a more difficult stage in the development process of thermal power enterprises and needs to be emphasized by enterprises.

In terms of indicative efficiency, there is a serious bifurcation in the green investment efficiency and social donation efficiency of thermal power enterprises. The difference between high-efficiency enterprises and low-efficiency enterprises even reaches 100%. This is strongly linked to the low-carbon transition strategy and operational financial status among thermal power enterprises.

In the benchmark regression analysis, environmental regulation is significantly positive at the 1% level, indicating that environmental regulation promotes green investment in electric utilities. This further confirms the accuracy of the DEA assessment.

In terms of the green investment focus of thermal power companies, compared to new energy construction, such as photovoltaic and wind power projects, thermal power unit retrofits are more effective in improving green investments in terms of economics and dexterity. Among the top 10 thermal power companies with the strongest improvement effect, eight of them have undertaken thermal power unit retrofits. Thermal unit retrofits are not only cheaper, but can also promote coal power and renewable energy interconnections. Therefore, their effect on energy utilization efficiency and green investment efficiency is more obvious.

Suggestions

Suggestions for thermal power enterprises.

First, thermal power enterprises should pay particular attention to green investment in the process of low-carbon transformation. Enterprises should not only target the expansion and upgrading of thermal power units, but also promote mature energy and low-carbon technologies.

Second, thermal power enterprises should achieve differentiated transformation according to their own situation. Due to wind power, photovoltaic and other new energy generation efficiencies are not high, and in the short term they cannot provide reliable power support. Thus, coal power installed capacity also needs to maintain reasonable growth.

Finally, thermal power companies should strengthen information disclosure. Through open and transparent information, investors can understand the enterprise’s green investment situation and the progress of low-carbon transformation as well as enhance investor confidence. In addition, through information disclosure, thermal power enterprises can also learn from the successful experience and lessons of other enterprises in order to improve their own green investment efficiency.

Suggestions for government departments

First, government departments should formulate medium- and long-term plans for the transformation of the thermal power industry as early as possible. The formulation of environmental regulations should be coordinated with market operation mechanisms. They can guide thermal power enterprises to form a market competition pattern for green investment. Governments can also provide policy preferences to enterprises that meet environmental protection standards and formulate and implement further incentive policies.

Second, in view of the phenomenon of increasing wind and solar curtailment in some local areas, government departments should coordinate solutions to the large-scale development and high-level consumption of new energy. When implementing unified dispatch across the entire grid, the State Grid Corporation should break through inter-provincial barriers, accelerate the construction of a new power system, and minimize the start-up period of thermal power as much as possible. At the same time, it can implement mandatory consumption of new energy across the entire grid. When wind and solar energy are curtailed, it can obligatorily reduce the output of matched thermal power and prioritize the transmission of new energy.

Data availability

All data generated or analyzed during this study are included in this published article and its supplementary information files.

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This study was supported by Jiangsu Province Social Science Foundation Project (22GLD019), Major Project of Philosophy and Social Science Research in Universities of Jiangsu Province (2022SJZD053).

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Ren, Fr., Wu, Tf., Ren, Yj. et al. The impact of environmental regulation on green investment efficiency of thermal power enterprises in China-based on a three-stage exogenous variable model. Sci Rep 14 , 8400 (2024). https://doi.org/10.1038/s41598-024-58396-x

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Published on 11.4.2024 in Vol 26 (2024)

This is a member publication of Imperial College London (Jisc)

Regulatory Standards and Guidance for the Use of Health Apps for Self-Management in Sub-Saharan Africa: Scoping Review

Authors of this article:

• Benard Ayaka Bene 1, 2 , MBBS, MPH   ; 
• Sunny Ibeneme 3 , MD, PhD   ; 
• Kayode Philip Fadahunsi 1 , MBBS, MPH   ; 
• Bala Isa Harri 4 , MBBS, MPH, MSc   ; 
• Nkiruka Ukor 5 , MSc   ; 
• Nikolaos Mastellos 1 , BSc, PhD   ; 
• Azeem Majeed 1 , MD   ; 
• Josip Car 1, 6 , MSc, MD, PhD  

1 Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, United Kingdom

2 Department of Public Health, Federal Ministry of Health, Abuja, Nigeria

3 Digital Health Specialist, UNICEF East Asia Pacific Regional Office, Bangkok, Thailand

4 Department of Health Planning, Research and Statistics, Federal Ministry of Health, Abuja, Nigeria

5 Strategic Health Information Cluster, World Health Organization, Abuja, Nigeria

6 School of Life Course & Population Sciences, King’s College London, London, United Kingdom

Corresponding Author:

Benard Ayaka Bene, MBBS, MPH

Department of Primary Care and Public Health

School of Public Health

Imperial College London

The Reynolds Building

St Dunstan’s Road

London, W6 8RP

United Kingdom

Phone: 44 7598439185

Email: [email protected]

Background: Health apps are increasingly recognized as crucial tools for enhancing health care delivery. Many countries, particularly those in sub-Saharan Africa, can substantially benefit from using health apps to support self-management and thus help to achieve universal health coverage and the third sustainable development goal. However, most health apps published in app stores are of unknown or poor quality, which poses a risk to patient safety. Regulatory standards and guidance can help address this risk and promote patient safety.

Objective: This review aims to assess the regulatory standards and guidance for health apps supporting evidence-based best practices in sub-Saharan Africa with a focus on self-management.

Methods: A methodological framework for scoping reviews was applied. A search strategy was built and applied across the following databases, gray literature sources, and institutional websites: PubMed, Scopus, World Health Organization (WHO) African Index Medicus, OpenGrey, WHO Regional Office for Africa Library, ICTworks, WHO Directory of eHealth policies, HIS Strengthening Resource Center, International Telecommunication Union, Ministry of Health websites, and Google. The search covered the period between January 2005 and January 2024. The findings were analyzed using a deductive descriptive content analysis. The policy analysis framework was adapted and used to organize the findings. The Reporting Items for Stakeholder Analysis tool guided the identification and mapping of key stakeholders based on their roles in regulating health apps for self-management.

Results: The study included 49 documents from 31 sub-Saharan African countries. While all the documents were relevant for stakeholder identification and mapping, only 3 regulatory standards and guidance contained relevant information on regulation of health apps. These standards and guidance primarily aimed to build mutual trust; promote integration, inclusion, and equitable access to services; and address implementation issues and poor coordination. They provided guidance on systems quality, software acquisition and maintenance, security measures, data exchange, interoperability and integration, involvement of relevant stakeholders, and equitable access to services. To enhance implementation, the standards highlight that legal authority, coordination of activities, building capacity, and monitoring and evaluation are required. A number of stakeholders, including governments, regulatory bodies, funders, intergovernmental and nongovernmental organizations, academia, and the health care community, were identified to play key roles in regulating health apps.

Conclusions: Health apps have huge potential to support self-management in sub-Saharan Africa, but the lack of regulatory standards and guidance constitutes a major barrier. Hence, for these apps to be safely and effectively integrated into health care, more attention should be given to regulation. Learning from countries with effective regulations can help sub-Saharan Africa build a more robust and responsive regulatory system, ensuring the safe and beneficial use of health apps across the region.

International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2018-025714

Introduction

Health apps are the most widely used digital health products globally [ 1 , 2 ]. Harnessing the potential of health apps creates a huge opportunity in providing support for health care delivery, including patient communication, patient education, and decision support for self-management [ 3 - 8 ]. Health apps can be an effective tool to strengthen health systems worldwide, especially in low- and middle-income countries including those in sub-Saharan Africa [ 4 , 5 , 9 ]. As a result, the attainment of universal health coverage (UHC) and sustainable development goal (SDG) 3, good health and well-being, can be accelerated [ 8 , 10 ].

Many health apps fall below the expected quality threshold [ 11 ]. Several studies have found that widely used health apps are often technically unreliable and clinically unsafe [ 12 - 14 ] and do not comply with ethical standards and the principles of confidentiality of information and data privacy [ 15 , 16 ]. In addition, many commercially available health apps were not developed using interoperability standards that are widely accepted in sub-Saharan Africa (eg, Fast Healthcare Interoperability Resources [FHIR]) [ 17 - 20 ]. Consequently, it becomes difficult to integrate these apps into a clinical workflow.

Hence, regulation through robust mechanisms is crucial to enhance the development, implementation, and adoption of health apps. Regulatory standards and guidance are essential for the safety of patients as they ensure quality assurance of any new technology in health care and contribute to building mutual trust while promoting the optimal use of the technology [ 21 - 23 ]. Therefore, to ensure that health apps that are used to support the self-management of patients are technically reliable and clinically safe, interoperable across systems, and compliant with the principles of confidentiality of information and data privacy, there is a need for effective regulatory standards. Furthermore, effective regulation can help ensure that health apps for self-management are culturally functional and competent and are accessible to those who need them regardless of gender, ethnicity, geographical location, or financial status [ 24 - 31 ].

Since 2005, there have been ongoing efforts to strengthen digital health governance at both the national and international levels [ 32 , 33 ]. In 2018, the World Health Organization (WHO) member states renewed their commitment to using digital health technologies (DHTs) to advance UHC and SDG 3 [ 33 ]. However, to date, the extent to which the use of health apps for self-management is regulated across countries within the WHO African Region (also known as sub-Saharan Africa) remains unclear. Therefore, this review was conducted to identify available regulatory standards and guidance and assess the extent to which they regulate health apps for self-management in sub-Saharan Africa. The review also mapped out the key stakeholders and their roles in regulating health apps for self-management across sub-Saharan Africa.

Review Questions

The review attempted to answer the following questions: (1) What regulatory standards and guidance are available for regulating health apps for self-management across sub-Saharan Africa? (2) To what extent do regulatory standards and guidance regulate health apps for self-management in terms of what aspects are regulated; why, how, and for whom; and what aspects are not regulated? (3) Who are the key stakeholders and what are their roles in regulating health apps for self-management?

Study Design

The process of this scoping review followed the methodological framework for conducting a scoping study originally described by Arksey and O’Malley [ 34 ] and the updated methodological guidance for conducting a Joanna Briggs Institute scoping review [ 34 - 37 ]. The reporting of the review was guided by the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist [ 38 ]. A completed PRISMA-ScR checklist is provided in Multimedia Appendix 1 . The protocol of this scoping review was published in BMJ Open [ 30 ].

Identifying Relevant Documents

Two reviewers (BAB and SI) developed the search strategy with the assistance of a librarian and in consultation with other research team members (KPF, BIH, NU, NM, AM, and JC). The following key terms were included: policy, legislation, strategy, regulation, standard, criterion, framework, guidance, guideline, digital health, eHealth, app, WHO African Region, and sub-Saharan Africa, and the names of all sub-Saharan African countries.

Owing to the absence of regulatory standards and guidance in scientific databases, the search focus was narrowed down to gray literature sources and institutional websites, including OpenGrey, WHO Regional Office for Africa (AFRO) Library, repositories for digital health policies (ICTworks, WHO’s Directory of eHealth Policies, and Health Information System Strengthening Resource Center), as well as the websites of WHO, International Telecommunication Union (ITU), and Ministries of Health (MOHs). The only scientific databases searched were PubMed, Scopus, and WHO AIM. PubMed was not included in the protocol. We also conducted a systematic search on Google. We used truncation to increase the yield of the results. The search strategy was then applied across PubMed, Scopus, and WHO AIM databases using Boolean terms (mainly OR and AND ) to combine search results. Gray literature sources and institutional websites were searched using phrases containing ≥2 keywords such as “eHealth regulation,” “digital health regulatory standard,” “eHealth regulatory standard,” “digital health regulation,” “digital health policy,” “eHealth policy,” “digital health strategy,” and “eHealth strategy.” For Google search, we added the names of the country to the phrases (eg, “digital health regulation Nigeria”). The reference lists of the included documents were also searched, and key individuals at the MOHs, WHO Country Offices, and the WHO AFRO were contacted for related documents. When our search was conducted, the WHO Directory of eHealth policies website was unavailable, and the WHO AFRO Library was undergoing reconstruction. The search strategies for PubMed, Scopus, and WHO AIM are provided in Multimedia Appendix 2 . The search was conducted between 2005 and January 2024.

Study Selection

The search results obtained from PubMed, Scopus, and WHO AIM were imported into Mendeley (Elsevier) [ 39 ] to remove duplicates. The search conducted on OpenGrey did not yield any results, whereas relevant records obtained from institutional websites, repositories, and Google were downloaded as PDF copies and uploaded to Mendeley. After removing duplicates, the remaining results were imported into Covidence (Veritas Health Innovation) [ 40 ] for screening. Two reviewers (BAB and SI) applied the predefined eligibility criteria ( Textbox 1 ) to screen the documents in 2 stages (title and abstract or executive summary). All discrepancies were discussed until the reviewers reached agreement.

Inclusion criteria

• Type of document: Regulatory standards, guidance, policies, strategies, and committee or government reports that address regulatory issues related to the use of health apps for self-management
• Location: Documents developed and implemented in countries within sub-Saharan Africa
• Date of publication: Documents developed since 2005; the global efforts toward promoting standards to minimize variability and potential harms that could arise from poorly regulated use of digital health began in 2005 [ 33 ]
• Language: Documents written in English language and other official languages of sub-Saharan African countries (Portuguese and French)

Exclusion criteria

• Type of document: Standards, guidance, policies, strategies, and reports not related to regulation of health apps
• Location: Documents from countries outside sub-Saharan Africa
• Date of publication: Documents developed before 2005
• Language: None

Data Charting (Extraction)

Two reviewers (BAB and SI), in consultation with the other members of the research team, developed the data extraction forms using an iterative process that included piloting data extraction and refinement until a consensus was reached.

We proposed in the study protocol [ 30 ] that data extraction would be conducted by the 2 reviewers independently. However, owing to the approach adopted for data extraction (deductive qualitative content analysis), 1 reviewer, rather than 2, initially extracted data from the included documents, and any concerns were discussed with a second reviewer [ 41 ]. Unresolved issues were then discussed and resolved with a third reviewer in a steering group meeting.

Collating, Summarizing, and Reporting Results

To address the research questions (particularly question 2), we adopted a deductive descriptive qualitative content analysis method to analyze and report the key findings. The policy analysis framework by Walt and Gilson [ 42 ] was adapted and applied to ensure that there was a consistent way of organizing the key findings: (1) Content (which aspects are regulated and which aspects are not?)—these are the components that directly or indirectly address regulatory issues related to the use of health apps for self-management, including areas that have not been addressed. (2) Context (why are those aspects regulated?)—this characterizes the rationale indicated for addressing regulatory issues related to the use of health apps for self-management. (3) Process (how are the regulatory standards developed and implemented?)—this describes the methods or approaches used to develop and implement regulatory standards. (4) Actors (who are the regulatory standards targeted toward?)—these are the key actors targeted by the standards.

Using a deductive descriptive qualitative content analysis approach, we examined each included document to systematically identify texts for concepts, patterns, and other relevant information. We then categorized them under content, context, process, or actors in relation to regulating health apps for self-management. The findings under content and context were further organized based on 4 predefined regulatory categories or themes as documented in the literature, namely (1) technical and clinical safety [ 12 - 14 ], (2) data protection and security [ 15 , 16 ], (3) standards and interoperability [ 28 , 31 ], and (4) inclusion and equitable access [ 24 - 29 ].

To address the third research question, the Reporting Items for Stakeholder Analysis (RISA) tool [ 41 ] was used as a guide to group key stakeholders based on role categorization as recognized globally by the WHO, the ITU, and UNESCO [ 32 , 33 , 43 ].

Ethical Considerations

Primary data were not collected in this study. Therefore, no ethics approval was required.

Search Results

A total of 2900 records were obtained after removing duplicates. Although the literature search was conducted in English, the search also yielded documents written in French and Portuguese from the ICTworks repository [ 44 ]. Following the initial screening of the title and abstract (or executive summaries), 73 documents were retrieved for full-text assessment. After applying the inclusion criteria for the full-text assessment, 49 documents were found eligible for inclusion in the review.

The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram [ 45 ] showing the study selection process is presented in Figure 1 .

Types of Documents

On the basis of the inclusion criteria, 3 categories of documents were considered for this review, namely “stand-alone regulatory standards and guidance that potentially regulate health apps for self-management,” “national policies and strategies on digital health,” and “other national documents that relate to the regulation of health apps for self-management.” Table 1 presents the types of documents obtained for each country within sub-Saharan Africa.

Characteristics of the Included Documents

Stand-alone regulatory standards and guidance.

We identified and included 6 stand-alone regulatory standards [ 18 , 19 , 46 - 49 ] from 3 countries (Ethiopia, Kenya, and Nigeria). All 6 documents were written in English. The years of development ranged between 2013 and 2021, as indicated in Multimedia Appendix 3 . The years of implementation were not specifically stated.

Although none of the included regulatory standards were exclusively developed to regulate health apps for self-management, 3 of them (Kenya Standards and Guidelines for mHealth Systems [ 18 ], Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ], and Health Sector Information and Communications Technology Standards and Guidelines [ 48 ]) provided concept and information relevant to the regulation of health apps and were included in the qualitative content analysis. The Kenya Standards and Guidelines for mHealth Systems [ 18 ] provides standards and guidelines on the design, development, and implementation of mobile health (mHealth) solutions to ensure they are interoperable, scalable, and sustainable. The Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] outlines the principles, requirements, and standards for eHealth systems interoperability in Kenya. The Health Sector Information and Communications Technology Standards and Guidelines [ 48 ] provide guidance and a consistent approach across the health sector in Kenya for establishing, acquiring, and maintaining current and future information systems and information and communications technology (ICT) infrastructure that foster interoperability across systems. These 3 documents are a good combination of regulatory standards and guidance that provide content and context relevant to the regulation of health apps in sub-Saharan Africa.

The remaining 3 standards (standard for electronic health record [EHR] system in Ethiopia [ 19 ], standards and guidelines for electronic medical record systems in Kenya [ 46 ], and the health information exchange standard operating procedure and guideline [ 49 ]) were exclusively developed for EHRs or electronic medical records. However, they contain information relevant for mapping stakeholders with potential roles in regulating health apps for supporting self-management.

National Policies and Strategies on Digital Health

This review includes 35 national policies and strategies that are related to digital health (potentially covering health apps) [ 50 - 84 ] from 31 countries written in English, French, and Portuguese (Benin, Botswana, Burkina Faso, Burundi, Cameroon, Comoros, Côte d’Ivoire [Ivory Coast], Democratic Republic of the Congo, Eswatini, Ethiopia, Gabon, Ghana, Kenya, Liberia, Madagascar, Malawi, Mali, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, South Africa, Tanzania, Togo, Uganda, Zambia, and Zimbabwe). Although the literature search was conducted in English, it also yielded documents written in French and Portuguese from the ICTworks repository. The years of development and implementation range between 2005 and 2030. Policies and strategies written in French and Portuguese were translated into English using Google Translate. Documents labeled as national development plans, strategic plans, and strategic development plans were considered as national strategies.

National policies and strategies do not offer specific standards or guidance, but rather outline the country’s vision, policy directions, and strategies for using digital technologies in health care. They provide useful information for identifying digital health stakeholders who can play a role in regulating health apps for self-management. For example, Nigeria has a separate National Digital Health Policy [ 72 ] and a National Digital Health Strategy [ 71 ]. Both documents were developed by building on the lessons learned from the end-term evaluation of the previous National Health ICT Strategic Framework [ 85 ]. They describe Nigeria’s renewed vision, mission, goals, objectives, and strategies for the development and implementation of digital health with the aim to improve the quality, efficiency, and effectiveness of health service delivery and health outcomes.

It is worth noting that for countries with >1 policy or strategy, we included only the most recent versions. For instance, as mentioned earlier, Nigeria now has both a national digital health policy and a national digital health strategy. These 2 documents supersede and thus replace the old National Health ICT Strategic Framework [ 86 ]. Details of included documents are presented in Multimedia Appendix 3 .

Other Related National Documents

We included 8 other documents [ 20 , 85 , 87 - 92 ] from 6 countries (Ethiopia, Kenya, Liberia, Nigeria, South Africa, and Tanzania) that did not fall under either stand-alone regulatory standards and guidance or national policies and strategies. These were mostly frameworks, road maps, and reports that potentially provide information relevant to the use of health apps. The years of development and implementation range from 2016 to 2025. These documents do not provide standards or guidance, but they contain information that can help map the digital health stakeholders that potentially play a role in regulating health apps for self-management. When multiple versions of a document exist, only the latest version was taken into consideration. Multimedia Appendix 3 provides details of the included documents.

Content: Aspects That Are Regulated and Aspects That Are Not

Technical and clinical safety.

Technical and clinical safety standards are required to prevent or minimize the harm that may arise from the use of the health ICT systems (including mHealth systems) as well as to improve the health outcomes and user satisfaction. As shown in Figure 2 , two subthemes were generated from included standards [ 18 , 47 , 48 ] as content under technical and clinical safety: v(1) guidance on system quality and (2) guidance on software or app development, acquisition, support, and maintenance.

Notably, 2 of the included standards [ 18 , 47 ] provide guidance on system quality to ensure the quality, security, reliability, performance, and maintenance of eHealth and mHealth systems. The Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] recommend the implementation of a data quality protocol to ensure that the data collection, collation, analysis, interpretation, dissemination, and use are managed in accordance with the quality standards. Similarly, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] recommends the inclusion of the following requirements in the technical manual: (1) minimum hardware requirements that should incorporate the preferred hardware architecture, (2) minimum software requirements that should include the minimum version of the underlying operating system as well as acceptable versions of related software, and (3) a detailed list of software dependencies (external libraries) necessary for the system to function properly.

The included standards [ 18 , 48 ] cover guidance on software or app development, acquisition, support, and maintenance, which aim to ensure the efficiency and effectiveness of eHealth and mHealth systems. The Kenya Standards and Guidelines for mHealth Systems [ 18 ] recommends a technical manual to provide a detailed description of the system’s installation and maintenance processes for system administrators and implementers; a developer’s guide for software developers and programmers to provide them with an overview of the system, description of the software design methodologies, description of the system architecture, and technical design diagrams; and a user manual to aid users in understanding how the system works and how each feature operates; in addition, the technical manual contains instructions for operating the software; entering and updating data; and generating, saving, and printing reports.

Although the contents generated here provide guidance that is relevant to health apps, they are not specific to health apps. Moreover, there are no clear measures to enable individuals or organizations that use health apps to manage clinical risk appropriately.

Data Protection and Security

Data protection and security are crucial aspects of managing patient information, thus ensuring the confidentiality, integrity, and availability of data as well as the rights and interests of the patient. Two subthemes related to data protection and security are (1) security measures for adequate protection of patients’ digital records and (2) guidance on data exchange.

The included standards [ 18 , 48 ] provide security measures for eHealth or mHealth systems to ensure the adequate protection of digitally accessible patient records. These measures include authentication, accountability, identification, authorization, integrity, confidentiality, availability, security, administration, and audit. This will help to achieve confidentiality, integrity, availability, and nonrepudiation of patient data or health records. Additional levels of security such as data encryption are required when there is a need to store sensitive information on removable devices or media or outside the MOH premises.

The Kenya Standards and Guidelines for mHealth Systems [ 18 ] provide the following guidance on data exchange to ensure privacy: (1) anonymize client data as much as possible before they can be shared; (2) where possible, use pseudonyms for the client data before they can be shared; (3) aggregate client data before they can be shared to reduce possibilities of tracing the data back to the client; and (4) minimize data so that access is available only to the data set required for that particular use. With regard to privacy rules, the Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] propose that a notice of privacy practices should be given to patients describing how their information may be used or shared while also specifying their legal rights.

Standards and Interoperability

Standards and interoperability are essential concepts in the field of IT, especially for systems that need to communicate and exchange data, as seen in the use of health apps for self-management. Two subthemes related to standards and interoperability are (1) interoperability as a basic requirement and (2) minimum standards to enable integration.

All the regulatory standards [ 18 , 47 , 48 ] highlight the importance of having interoperability as a basic requirement when selecting software products or services for use within the health system. This facilitates interaction across systems. For instance, to facilitate seamless interaction between mHealth systems and primary information systems for data capture, reporting, and decision support in various domains of the health system, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] recommends the incorporation of at least 3 types of interoperability, namely, technical interoperability, semantic interoperability, and process interoperability.

Furthermore, 2 regulatory standards [ 18 , 47 ] proposed minimum interoperability standards to enable the integration of services and data exchange between various systems in health care. For instance, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] suggests standards (for interoperability) for mHealth systems that are consistent with the recommendations in internationally accepted standards. They include the following: (1) clinical messaging—ensuring mHealth systems conform to Health Level 7 (HL7) version 3 standards and corresponding implementation guideline; (2) clinical terminology—ensuring terminologies and classifications for clinical concepts (eg, International Classification of Diseases, tenth revision—for diseases; Systemized Nomenclature of Medicine—for clinical data coding; Logical Observation Identifiers Names and Codes—for laboratories; and RxNorm—for Pharmacies); (3) the mHealth system must use the latest versions of international standards, such as HL7 Clinical Document Architecture for electronic sharing of clinical documents; (4) concepts—mHealth systems will use the idea of “concepts” so that information can be transmitted between systems without losing meaning or context, and HL7 Reference Implementation Model or other appropriate standards are recommended for implementing concepts; (5) architecture—to develop mHealth systems, developers should define the system architecture that should include data elements and business logic. Furthermore, to define how mHealth systems interact with other systems, developers of mHealth solutions must provide application programming interfaces. FHIR is the preferred application programming interface interoperability standard.

Inclusion and Equitable Access

Inclusion and equitable access are essential principles to ensure that health apps are culturally appropriate and relevant and accessible to everyone, regardless of gender, ethnicity, location, or economic status.

All the included regulatory standards [ 18 , 47 , 48 ] indicate that they were developed based on a combination of participatory and consultative approaches involving multiple actors or stakeholders, thus promoting inclusion. However, there are no specific measures or guidance to ensure adequate engagement and representation of all the relevant stakeholders and to sustain that engagement.

The Kenya Standards and Guidelines for mHealth Systems [ 18 ] proposes the following systems attributes to ensure equitable access to mHealth services at all times and from anywhere: (1) allocation of adequate storage and bandwidth capacity; (2) fast response time; (3) fast recovery capabilities; (4) performance monitoring; (5) business continuity processes, for example, backups; and (6) redundant sites and links. Furthermore, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] prescribes the following metrics for measuring system availability: (1) downtime per year, (2) mean time between failure, (3) mean time to repair, and (4) failure in time.

Although the abovementioned systems attributes and metrics for measuring system availability are important, the included standards do not offer any concrete guidance or model for achieving a sustainable funding mechanism for health apps to ensure that they are readily available and accessible to those who need them.

Context: Reasons Why Those Aspects Are Regulated

The 3 standards [ 18 , 47 , 48 ] were developed to address unsafe, isolated, and inconsistent implementation. The Health Sector ICT Standards and Guidelines [ 48 ] suggest that although there has been a lot of ICT investment in the health sector leading to improvement in service delivery and information exchange, there remains the challenge of inconsistency in ICT implementation and harmonization of the health sector system requirements. Hence, there is a need to adopt global best practices for software development, acquisition, support, and maintenance by the MOH. In addition, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] indicates that standards and guidelines are necessary to ensure a consistent approach to the development of ICT systems. Similarly, the Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] recognize the need to ensure that the processes of collecting, collating, analyzing, interpreting, disseminating, and using data are consistent with data quality standards.

To build mutual trust and maximize the benefits of eHealth information exchange, the Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] reiterate that as health data are constantly being exchanged across health information systems, robust security standards are required to maintain their integrity and confidentiality. This will build the trust of service users and consequently help to maximize the benefits of eHealth information exchange such as in self-management.

Two of the included regulatory standards [ 47 , 48 ] indicate that the context for standards and interoperability was (1) to address poor coordination, duplication of efforts, and inefficient use of resources and (2) to promote the integration of ICT systems.

The Kenya Standards and Guidelines for E-Health Systems Interoperability [ 47 ] acknowledge that the absence of interoperability standards over the years has led to the duplication of efforts and the inefficient use of ICT resources in health care. Now that ICT has become increasingly relevant in improving efficiency in health service delivery, the Kenya MOH recognizes the need to adopt a standardized approach, hence the development of interoperability standards for eHealth systems. In addition, the Health Sector ICT Standards and Guidelines [ 48 ] emphasize the relevance of interoperability as a requirement for addressing the inconsistency in implementing ICT in the health sector.

The Health Sector ICT Standards and Guidelines [ 48 ] consider “integration of ICT systems” as one of its key guiding principles, acknowledging the lack of information systems integration as a challenge experienced by ICT services across Kenya.

The contexts for inclusion and equitable access as generated from included standards [ 18 , 47 , 48 ] were (1) to promote inclusion and (2) to promote equitable access to services.

To promote inclusion, the standards [ 18 , 47 , 48 ] highlight the importance of involving and engaging multiple actors and stakeholders during the development process. However, no emphasis was placed on the need to sustain stakeholder engagement during the implementation process.

Pertaining to equitable access, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] acknowledges that the public health care system is largely unavailable to most of the population in many developing countries because of geographical location, resource constraints, inefficiencies, and lack of awareness. Hence, it recognizes the importance of ensuring that mHealth services are always accessible by users and from anywhere as well as the need to put in place mechanisms to make this happen.

Process: How the Regulations Are Developed and Implemented

Two themes were generated from the included standards: development and implementation processes [ 18 , 47 , 48 ].

Development Process

All the included standards [ 18 , 47 , 48 ] indicate that they were developed through a participatory process and in consultation with a range of subject experts and interest groups. In addition, the standards [ 18 , 47 , 48 ] adopted a multisectoral approach to engage health-related stakeholders from government ministries or agencies and development partners and a range of subject experts and interest groups. It has also been reported that these standards [ 18 , 47 , 48 ] were developed based on international best practices and with reference to international standards. However, there is no indication that a stakeholder engagement strategy was adopted to sustain the engagement of stakeholders through the entire development and implementation process.

Implementation Process

The 3 regulatory standards [ 18 , 47 , 48 ] identify the key requirements to ensure effective implementation of IT services in the health sector. These are (1) legal authority, (2) coordination, (3) building capacity, and (4) monitoring and evaluation.

The included standards [ 18 , 47 , 48 ] were established based on the legal provisions enshrined in the health and other related acts and laws of Kenya as well as the relevant policies and strategies. Hence, it is expected that their implementation will comply with and be backed by those legal provisions. For example, the Health Sector ICT Standards and Guidelines [ 48 ] indicate that its implementation will be supported by the authority from the Kenya Communications Act 2009, E-Government Strategy, and National ICT Policy. Similarly, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] asserts that it will be implemented by complying with existing and relevant national policies, legal frameworks, strategies, and standards, including the Health Information Policy, ICT Standards, and System Interoperability Principles.

The included standards [ 18 , 47 , 48 ] report that the implementation of regulations will require robust coordination mechanisms. For instance, the Health Sector ICT Standards and Guidelines [ 48 ] indicate that, as the Ministry’s ICT resource manager, the principal secretary (also the head of ICT), in collaboration with the ICT Governance Committee, is responsible for coordinating the implementation of the standard. The ICT Governance Committee comprises representatives from the heads of departments and ICT development partners in the health sector. The committee’s responsibilities include overseeing, enforcing, and reviewing standards as well as initiating ICT projects.

The Health Sector ICT Standards and Guidelines [ 48 ] highlight the need for capacity building or training of the MOH staff and stakeholders who are the primary users of the Ministry’s ICT services. This will enhance their capacity to implement the guidelines provided in the document in line with the ministry’s human resource development policies, regulations, and rules. However, it is acknowledged that building capacity for health ICT is a challenge given that there is low adoption of ICT among health providers, and ICT is not routinely included in the course content of most training programs. The Kenya Standards and Guidelines for mHealth Systems [ 18 ] listed the “number of mHealth practitioners trained on the standards and guidelines” as one of the indicators for monitoring and evaluating mHealth interventions.

The Health Sector ICT Standards and Guidelines [ 48 ] assert that monitoring and evaluation is an essential role of the MOH to ensure efficiency, accountability, and transparency throughout the implementation period. It further stresses that all those who use the Ministry’s ICT services are required to adhere to the provisions in the standard as the MOH will carry out quarterly monitoring exercises on the use of the standard to ensure compliance based on clear indicators. Furthermore, the ICT Governance Committee will periodically review and amend the standard to keep it relevant and effective. Similarly, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] establishes the following key indicators for effectively monitoring and evaluating the implementation of the standards and guidelines: (1) the number of counties in which the MOH has disseminated the standards and guidelines, (2) the number of counties successfully implementing the standards and guidelines, (3) the number of mHealth practitioners trained on the standards and guidelines, (4) the number of mHealth practitioners accessing the standards and guidelines, (5) the number of mHealth practitioners who correctly understand the standards and guidelines, (6) the number of stakeholders who adhere to the standards and guidelines, (7) the number of mHealth systems that follow the required development steps, and (8) the number of mHealth practitioners who have implemented their systems by using the standards and guidelines. In addition, the Kenya Standards and Guidelines for mHealth Systems [ 18 ] indicates that the outlined standards will be reviewed every 3 years to ensure they are up to date with new changes including the changes in policies and systems upgrades.

Although all the abovementioned indicators are relevant, the implementation process is not explicit on the approach for regulating health apps and ensuring compliance with regulatory standards and guidance.

Actors: Those the Regulations Are Targeted at

The included standards [ 18 , 47 , 48 ] identified 2 main groups of actors for whom the regulations and guidance were targeted. They included (1) those who provide digital health services and (2) those who use the ICT infrastructure of the MOH.

Two of the standards [ 47 , 48 ] indicated that the regulations should be implemented by all individuals and organizations that provide ICT-related health care services to the public. Similarly, the Health Sector ICT Standards and Guidelines [ 48 ] state that all those who access or use the MOH ICT infrastructure are expected to adhere to the guidelines outlined in the document.

Mapping of Stakeholders

To address the third research question, we conducted a stakeholder mapping guided by the RISA tool [ 41 ].

A total of 11 categories of key stakeholders were identified from all 49 included documents (6 stand-alone regulatory standards and guidance, 35 national policies or strategies, and 8 other related documents). These categories are consistent with the digital health stakeholders recognized by the WHO, ITU, and UNESCO [ 32 , 33 , 43 ]. Table 2 presents the mapping of stakeholders according to their role categorization. A more detailed table with a potential role description with regard to regulating health apps for self-management is presented in Multimedia Appendix 4 .

a WHO: World Health Organization.

This paper presents the findings of a scoping review of regulatory standards and guidance for the use of health apps for self-management in sub-Saharan Africa. To the best of our knowledge, this is the first study that attempted to identify and assess the extent to which regulatory standards and guidance regulate and guide the use of health apps for self-management in sub-Saharan Africa as well as map out the key stakeholders and their potential roles.

Our findings reveal that only 1 country (Kenya) in sub-Saharan Africa currently has national regulatory standards that could potentially regulate the use of health apps for self-management. The included standards failed to adequately address adequate attention to inclusion and equitable access. This is concerning given the growing need to promote the adoption of culturally appropriate and relevant health apps and to ensure that they are available to those who need them regardless of gender, ethnicity, geographical location, or financial status [ 24 - 29 ]. Consequently, this review provides insights into the regulation of health apps for self-management in sub-Saharan Africa, which needs to be given more attention if the potential of these apps is to be harnessed in the region.

Principal Findings

We identified 49 documents from 31 countries in sub-Saharan Africa. Although none of the included standards provided a specific set of regulations on health apps for self-management, we identified 3 standards [ 18 , 47 , 48 ] that provided relevant information regarding the regulation of health apps. The included national policies and strategies, in contrast, only outline the goals and commitments made by national governments to promote the adoption of digital technologies in the health sector and the plans and paths set forth to achieve these goals. However, the information they provided was relevant for identifying and mapping digital health stakeholders who potentially have vital roles in regulating the use of health apps for self-management.

The policy analysis framework (content, context, process, and actors) [ 42 ] was adapted and applied to organize the key findings. The content covered the following areas: guidance on systems quality; guidance on software and app development, acquisition, support, and maintenance; security measures for adequate protection of patients’ digital records; guidance on data exchange; interoperability as a basic requirement; minimum standards to enable integration; involvement and engagement of relevant stakeholders; and system attributes for equitable access to services. Meanwhile, the context was to address unsafe, isolated, and inconsistent implementation; to build mutual trust and maximize the benefits of eHealth information exchange; to address poor coordination, duplication of efforts, and inefficient use of resources; to promote the integration of ICT systems; and to promote inclusion and equitable access to services. The process involved the development process (which covers participatory and consultative processes and multisectoral approach, with reference to international standards and best practices) and the implementation process (which covers legal authority, coordination, capacity building, and monitoring and evaluation). The targeted actors were those who provided digital health services and those who used the ICT infrastructure of the MOH.

Furthermore, key stakeholders with potential roles in regulating health apps for self-management were identified. They include the government, regulatory bodies, funders, intergovernmental and nongovernmental organizations, academia, and the health care community.

Implications of the Study Findings for Practice

Regulatory standards and guidance act as a bridge between technological innovation and its safe and effective use in health care. They ensure that while technology continues to advance, the safety and trust of patients are never compromised. Among the plethora of health apps on the market, the over-the-counter, nonregulated apps such as wellness and fitness apps are the most mainstream [ 93 - 95 ]. On the other side of the spectrum, there are regulated health apps that are classified under medical devices or software as medical device products [ 94 , 95 ]. Some of these are prescription-only apps, such as digital therapeutics (DTx) apps for managing substance dependence [ 95 , 96 ].

Although some high-income countries have made significant strides in ensuring the safety, effectiveness, and accessibility of health apps, the journey has indeed not been without challenges and hurdles. Sub-Saharan Africa, although dealing with its own unique set of challenges, has the opportunity to learn from the experiences of these high-income countries. This could potentially allow the region to bypass some of the hurdles encountered by high-income countries in their journeys.

Technical and clinical safety are essential requirements that health apps must meet before they can be considered for use for self-management to minimize the risk of harm to patients. It is well documented that health apps that function poorly pose a serious threat to the safety of patients. An example illustrating how health apps used for self-management can threaten patient safety is evident in a study [ 12 ]. This study [ 12 ] revealed that widely used health apps designed to calculate and estimate insulin doses could endanger patients by providing incorrect or inappropriate dose recommendations. Similarly, 2 successive studies that assessed the contents and tools of apps for asthma discovered that none of the apps in the first study offered comprehensive information or adequate tools for asthma self-management, whereas the follow-up study, which was conducted 2 years later, showed a 2-fold increase in the number of asthma apps, yet there was no improvement in the content and tools offered by the newer apps. In fact, many apps recommended self-management procedures that were not supported by evidence [ 13 , 14 ]. Accordingly, some health apps that support the self-management of long-term conditions do not adhere to evidence-based guidelines and are unresponsive to the evolving health needs of patients.

Although the context of included regulatory standards with regard to technical and clinical safety was to address unsafe, isolated, and inconsistent implementation, the guidance provided by these regulatory standards is not specific to health apps, and they do not provide appropriate guidance and standards for health organizations and other key stakeholders to establish a framework for managing the clinical risks associated with deploying and implementing self-management health apps. Considering the rapid advancements in digital health (including artificial intelligence [AI] or machine learning and big data), health apps will increasingly play a crucial role in supporting self-management through digitally enabled care pathways that will improve personalized care and health outcomes [ 97 , 98 ]. Therefore, it is imperative to ensure the technical reliability and clinical safety of health apps for self-management through robust regulatory standards and guidance. For instance, a guide on the criteria for health app assessment, developed by the UK government, includes technical stability and clinical safety as criteria for deciding whether health apps should be considered for use in the National Health Service (NHS) [ 99 ]. In addition, medical device apps are required to conform to the NHS clinical risk management standards as part of the clinical safety requirements [ 99 , 100 ]. In the event of any concerns regarding the safety of a medical device app, the Yellow Card reporting system can be used by a responsible clinical safety officer or any other individual to notify the Medicines and Healthcare products Regulatory Agency (MHRA) [ 101 , 102 ].

To adequately manage patient information when health apps are used for self-management, data protection and security standards and guidance are required. They guarantee that data are kept and handled safely and responsibly within the provisions of the law and that patients’ rights and interests are respected.

There have been ongoing concerns about compliance with ethical standards, the principles of confidentiality of information, and data privacy. For example, an assessment of apps that had previously been endorsed by the former UK NHS Apps Library revealed substantial gaps in compliance with data protection principles regarding the collection, storage, and transmission of personal information. This has raised a fundamental concern about the credibility of developer disclosures and whether these disclosures can be trusted by certification programs [ 15 ]. A study assessed the privacy practices of the 36 most popular apps for depression and smoking cessation for Android and iOS in the United States and Australia [ 16 ]. The findings revealed that although only 69% (25/36) of the apps included a privacy policy, 92% (33/36) of the apps shared data with a third party, and only 92% (23/25 with privacy policy) of the apps disclosed sharing data with a third party in their policy. Although 81% (29/36) of the apps shared data with Google and Facebook for the purposes of advertising, marketing, or analytics, only 43% (12/28) of the apps that shared data with Google and 50% (6/12) of the apps that shared data with Facebook disclosed this in their policy [ 16 ].

In this regard, health app developers and providers in the United Kingdom are required to conduct a data protection risk assessment before they launch or update their apps to ensure compliance with the United Kingdom General Data Protection Regulation (GDPR) and other relevant regulations, including the Data Protection Act 2018 [ 103 ]. By conducting a data protection risk assessment, health app developers and providers can demonstrate that they are accountable; they respect the privacy and dignity of their users; and that they deliver safe, effective, and ethical solutions [ 104 ].

Health apps are expected to play an increasingly important role in supporting self-management. However, this ambition can only be achieved if citizens trust that these apps are collecting and analyzing data safely and in accordance with robust regulatory standards and guidance. It is also crucial that these apps provide reliable information that clinicians can act on [ 98 ]. The context of the standards included in this study regarding data protection and security was to build mutual trust and maximize the benefits of eHealth information exchange. Trust is a key factor in the successful adoption and use of health apps, and transparency in data handling and clinical decision-making is essential to build and maintain that trust. This is also paramount for the widespread acceptance and impact of health apps on health care outcomes in sub-Saharan Africa.

We acknowledge the existence of numerous national laws related to data protection and security outside the health sector. Hence, guidelines that link these legislations together must be provided to ensure compliance with all relevant laws and guidance when using patient data. An example of how to achieve this is the United Kingdome’s guide to good practice for digital and data-driven health technologies that provides guidelines on how to abide by the laws and principles that govern data security and protection in the United Kingdom, including the GDPR, Data Protection Act 2018, and Caldicott Principles [ 105 ].

Standards and interoperability are essential for effectively developing, deploying, and implementing health apps to support self-management in sub-Saharan Africa. Interoperability is the ability of different systems, devices, or applications to communicate and exchange data with each other in a coordinated manner, thus providing timely and seamless portable information across organizational, regional, and national boundaries and optimizing both individual and population health [ 106 ]. In the same vein, standards enable interoperability between systems or devices through a common language and a common set of expectations [ 106 ].

Interoperability is crucial in improving the quality, safety, and efficiency of care delivery as well as empowering patients and providers with access to relevant and timely information [ 99 ]. One of the most widely used and accepted interoperability standards for health care data exchange is FHIR [ 106 , 107 ]. FHIR is a global industry standard developed by HL7 International. FHIR is designed to be quick to learn and implement and to support a variety of use cases, including self-management [ 108 ]. By using apps that are based on an FHIR standard, patients can benefit from data analytics that show how their health data relate to their chronic conditions or wellness goals [ 109 ]. They could also access all their health information from one place, even if they visit different health professionals who use different electronic medical records or EHR, thus promoting integrated care [ 28 , 31 , 33 , 109 - 115 ]. As a result, patient care can easily be coordinated.

The context of the included regulatory standards with regard to standards and interoperability was to address poor coordination, duplication of efforts, and inefficient use of resources and to promote the integration of ICT systems. However, in sub-Saharan Africa, there are many challenges and barriers to the adoption and implementation of interoperability standards, such as the lack of awareness or knowledge of the benefits and requirements of interoperability standards among stakeholders; lack of incentives or regulations to encourage or enforce the adoption of interoperability standards by app developers and vendors; lack of resources or capacity to implement interoperability standards, including technical expertise, infrastructure, funding, or governance; and lack of alignment or coordination among the different actors and initiatives involved in developing, deploying, and implementing the digital health interventions [ 30 , 116 - 119 ]. To address these challenges, some possible solutions may include raising awareness and education on the importance and value of interoperability standards for health apps among all relevant actors; developing and implementing policies and guidelines that promote or mandate the use of interoperability standards by app developers and vendors; providing technical assistance and support for app developers and vendors to adopt and implement interoperability standards, such as tools, frameworks, testing, certification, or accreditation; and establishing and strengthening collaboration and coordination among the different stakeholders and initiatives involved in health app development, deployment, and implementation in sub-Saharan Africa. In addition, the Digital Health Platform Handbook, a toolkit developed by the collaborative efforts of the WHO and ITU [ 120 ], can help countries in sub-Saharan Africa to develop and implement digital health platforms as the underlying infrastructure for interoperable and integrated national digital health systems. The digital health platform is a system-wide approach to developing digital health solutions with the aim to overcome the problems of siloed, vertical, and isolated applications and systems that hamper data management, innovation, efficiency, and impact in the health sector.

Inclusion and equitable access are crucial to ensuring that health apps and related services are culturally appropriate and relevant as well as accessible to all who need them, regardless of gender, ethnicity, geographical location, ability, or financial status [ 24 - 29 ]. This is the key to promoting a “sense of belonging” and “ownership” and thus underscoring the importance of stakeholder mapping and involvement or engagement through the development and implementation process [ 22 ].

In this study, the included regulatory standards demonstrate the importance of inclusion by adopting both a participatory and consultative approach involving multiple stakeholders from different sectors. However, the standards do not provide clear guidance to ensure the adequate participation and sustained engagement of all relevant stakeholders. The lack of concise guidance to ensure the adequate participation and engagement of all relevant stakeholders, especially the susceptible and disadvantaged groups, can increase the risk of tokenistic tendencies, which can undermine the cultural appropriateness of health apps [ 25 , 121 ]. Some susceptible groups, such as women and people with low socioeconomic status, may face additional barriers to accessing and using health apps, such as lack of digital literacy, privacy concerns, cultural norms, or stigma [ 25 ]. Similarly, the cost of developing, maintaining, and updating health apps may not be covered by public or private health insurance schemes, which could limit their affordability and availability for low-income or uninsured populations [ 95 ]. However, there is no specific guidance or model for an effective funding mechanism for health apps in the included regulatory standards.

To address these challenges and ensure equitable access to health apps for self-management in sub-Saharan Africa, possible measures may include developing policies and regulations that support integrating health app interventions into existing health systems and financing mechanisms and engaging with stakeholders from different sectors and backgrounds (including health professionals, patients, communities, governments, civil society, academia, and industry) to co-develop and co-implement frameworks or models that promote the use of health apps for self-management in ways that are responsive to the local context and needs. Moreover, establishing regulations that provide appropriate financing or reimbursement options will reduce the risk of developers of good quality health apps turning to data mining for revenue, thus increasing privacy concerns [ 95 ]. For instance, in Germany, the reimbursement of health apps classified as medical devices (Digitale Gesundheitsanwendungen) was introduced in 2021 under the statutory health insurance [ 122 , 123 ]. When a medical device is prescribed by a physician or a physiotherapist, the manufacturer must submit an application to the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) for approval [ 123 ]. The Federal Association of the Statutory Health Insurance Funds (Spitzenverband Bund der Krankenkassen) determines and negotiates the reimbursement thresholds following approval. However, the manufacturer must demonstrate that the app is safe, functional, and of good quality; complies with data protection requirements; and benefits patient care [ 123 ].

The process of regulating health apps essentially involves the development and implementation of regulatory standards and guidance. According to our study, the development process comprises a participatory and consultative process, a multisectoral approach, and a reference to international standards and best practices. In contrast, the implementation process is ongoing and requires appropriate legal authority, coordination, capacity building, and monitoring and evaluation.

We recognize that health apps can be accessed and used by patients from different parts of the world, and this means that countries need to carefully consider whether health apps that are accessed and used by their citizens meet the national or regional legal and ethical requirements, including their cultural and linguistic needs [ 23 ]. For countries in sub-Saharan Africa, a cross-border or regional collaboration between national legal authorities through the coordination of agencies such as the African Medicines Regulatory Harmonization (AMRH) may help to ensure that health apps built for the region are safe, effective, and user-friendly for everyone, considering the contextual differences of the countries [ 23 ]. For instance, all medical device companies that want to sell their products in the European market must obtain a Conformité Européenne (CE) mark for their devices, which indicates that they meet the legal requirements and can be freely circulated within the European Union [ 124 ]. Although the European Union member states regulate medical devices, the European Medicines Agency is involved in the regulatory process.

The regulation of health apps is extremely complex and involves a wide range of stakeholders. Therefore, a robust coordination mechanism is essential to reduce the risk of fragmentation and duplication of efforts and to promote the efficient use of resources. Most countries in sub-Saharan Africa have units in health ministries that coordinate and oversee the regulation of medical products. These units should be autonomous, full-fledged departments with legal authority (boards or commissions) to ensure independent, transparent, and accountable decision-making, but this is often not the case [ 125 ]. These units are recognized by the national authorities as regulators (eg, the National Medicines Regulatory Authority [NMRA]) [ 126 ]. Such organizational structures hinder the effectiveness of the national regulatory authorities in fulfilling their mandate and prevent the establishment of quality management systems to ensure transparent and accountable decision-making [ 125 ].

Furthermore, Essén et al [ 23 ] analyzed health app policy or regulation in 9 high-income countries (Sweden, Norway, Denmark, Netherlands, Belgium, Germany, England, the United States, and Singapore) and found that most of these countries adopted centralized approaches to app evaluation. Although centralized approaches might have advantages over self-evaluation, they may create bottlenecks and limit the availability of high-quality health apps for users. As suggested by Essén et al [ 23 ], a decentralized approach, such as the accreditation of evaluation agencies, maybe a worthwhile solution. However, this will require adequate coordination to ensure the consistency and reliability of the evaluation criteria and methods across different agencies as well as the transparency and accountability of the accreditation process. A possible way to achieve this is to adopt a common framework that can guide the evaluation and accreditation of health apps.

Similarly, the postmarket surveillance (PMS) system, which is a new regulation for medical devices in Europe, is a process of collecting and analyzing data on medical devices after they have been launched into the market to ensure their safety and performance and to identify any problems or need for improvements [ 127 , 128 ]. The PMS system is important because premarket data, which are obtained from testing a medical device before it is launched, have limitations in capturing the long-term performance and risks of the device [ 128 ]. Currently, the PMS system does not cover fitness and wellness apps, which are commonly used in self-management. Hence, Yu [ 93 ] proposed that the PMS system should also be applied to DHTs, such as fitness and wellness apps. They argue that the postmarket data would help regulators periodically review and adjust the regulatory standards for these groups of health apps based on their risks and benefits.

Drawing on the experience of the United Kingdom, it can be clearly demonstrated that the regulation of health apps is a complex, a multifaceted, and an evolving process that involves different regulators and criteria depending on the nature and function of the app. For instance, a centralized NHS Apps Library was launched as a beta site in April 2017 to provide patients with a collection of trusted and easy-to-use digital health tools [ 129 ]. The library provided access to a range of health apps that were reviewed and approved by the NHS, including apps that could help patients manage conditions such as diabetes, mental health, and chronic obstructive pulmonary disease [ 130 ]. However, the library was closed in December 2021 [ 131 ]. Although no reason for the closure was provided on the website, it is likely because of persistent concerns regarding the safety of patients and data privacy involving multiple apps including those listed in the library [ 12 , 14 - 16 , 131 , 132 ]. The NHS App was introduced in January 2019 before the closure of the NHS Apps Library to serve as the gateway for accessing NHS services including ordering repeat prescriptions and booking or managing appointments [ 133 ].

Furthermore, the United Kingdom Health Security Agency, formerly known as Public Health England, issued a guidance on criteria for health app assessment in October 2017 [ 99 ]. The purpose of this guidance was to ensure that all health apps built for the UK population work well and provide clear information about their functions, benefits, and intended outcomes for patients and health care professionals. On the basis of this guidance, those intending to build an app are required to conform to certain regulations before being considered for the app assessment process. The 2 main regulations are the medical device regulation and the Care Quality Commission (CQC) registration. Apps that are considered as medical devices must register with the MHRA and have a CE mark. Apps providing health or social care that fit into 1 of 14 regulated activities are required to register with the CQC before they can be assessed [ 134 ]. CQC is an independent regulator of health and social care services in England.

Similarly, the Organisation for the Review of Care and Health Apps (ORCHA) is a UK-based organization that independently evaluates and distributes health apps. It provides services such as app review, accreditation, curation, and recommendation within the United Kingdom and across the world [ 135 ]. ORCHA also enables organizations (including the NHS) to build a decentralized web-based digital health library of consumer-friendly over-the-counter apps [ 135 - 137 ]. These apps are continuously assessed by ORCHA against the standards and regulations in clinical and professional assurance, data quality and privacy, and usability and accessibility [ 137 ].

In addition, the Digital Technology Assessment Criteria (DTAC) were introduced in beta in October 2020, and its first official version was subsequently launched in February 2021 [ 138 ]. The DTAC plays a crucial role in ensuring that digital health tools meet the necessary standards in areas such as clinical safety, data protection, technical security, interoperability, usability, and accessibility. By serving as the national baseline criteria for DHTs in the NHS and social care, it provides a valuable framework for health care organizations during procurement. It also offers guidance for developers on the expectations for their digital technologies within the NHS and social care. This is an example of how a harmonized framework can help ensure the quality and safety of DHTs, including health apps.

In addition, the National Institute for Health and Care Excellence Evidence Standards Framework is a set of evidence standards for a wide range of DHTs designed to help evaluators and decision makers in the health care system to consistently identify DHTs that are likely to offer benefits to the users and the health care system [ 139 ]. The Evidence Standards Framework was first published in March 2019 and is ideally used before DHTs (including health apps) are considered for commissioning or procurement by the NHS [ 140 ]. It is a crucial tool for ensuring that DHTs are clinically effective and offer value to the health and care system in the United Kingdom. In August 2022, the framework was updated to include AI and data-driven technologies with adaptive algorithms [ 140 ].

Furthermore, DTx apps, which are a type of medical device, are not allowed into the UK market unless they comply with the UK GDPR and meet the requirements of DTAC. In addition, they must bear the CE or UK Conformity Assessed marks [ 141 ]. This means that DTx apps must demonstrate their safety and efficacy through clinical trials and comply with the relevant regulations for data protection and quality standards as regulated by the MHRA. DTx products are also recognized as DHTs under the National Institute for Health and Care Excellence Evidence Standards Framework [ 142 ]. DTx incorporates software to treat, prevent, or manage specific diseases or conditions [ 143 , 144 ]. The fact that DTx products typically focus on a narrow clinical indication and generate evidence of clinical efficacy underscores their potential to make a substantial contribution to self-management and health care delivery in general. The increasing recognition of the role of DTx in patient care by regulators is also noteworthy, and the creation of regulatory and reimbursement pathways for approved apps further enables DTx products to continue to play an important role in impacting health care delivery [ 1 , 143 ]. This is a testament to the potential of regulated health apps to revolutionize health care and improve patient outcomes.

Among the many lessons to learn from the experience of the United Kingdom is that the regulation of health apps must evolve to keep pace with advances in DHTs and adapt to the changing needs and demands of digital health. Moreover, efforts are being made to streamline the multifaceted approaches to simplify app regulation and access in the United Kingdom [ 23 ]. Therefore, a robust and dynamic coordination mechanism, along with political will, skilled personnel, reliable funding, and a robust framework for monitoring and evaluating progress and aligning key performance indicators, is essential for countries in sub-Saharan Africa to keep pace with the advancement in the regulation of health apps. There is also a need to strengthen collaboration and ensure regulatory harmonization among national regulatory authorities and continental bodies such as the regional economic communities, AMRH, and the WHO AFRO [ 126 ].

Capacity building and monitoring and evaluation are important factors for ensuring effective regulation of health apps given the complex nature of the process. The regulation of medical products (including health apps) in sub-Saharan Africa generally includes licensing and accreditation, evaluation, inspection, quality control, information dissemination and promotion, and monitoring of adverse events [ 125 ]. Therefore, high-level skills as well as effective monitoring and evaluation will be required to ensure the success of the process. For most countries in sub-Saharan Africa, the NMRA is responsible for coordinating and overseeing the regulatory system of medical products [ 125 , 126 ]. However, in most cases, NMRAs are unable to perform the core regulatory functions expected of them [ 145 ]. More than 90% of African countries have limited or no capacity to regulate medical products, with only 7% having moderately developed capabilities [ 145 ]. The lack of effective NMRAs in Africa exposes the citizens to potential harm by allowing unsafe, low-quality, and fake medical products to circulate and be used [ 145 ].

Although it is the responsibility of governments to establish functional regulatory systems and ensure effective monitoring and evaluation of the regulatory process, the involvement of international and continental organizations to support sub-Saharan African countries improve the regulatory capacity of their national regulatory agencies would be extremely beneficial. For instance, the African Medicines Agency (AMA) was established in November 2019 as a treaty adopted by the African Union Member States to help address the concerns arising from weak regulatory systems on the continent. At present, 37 countries have signed the AMA treaty, including 26 countries that have ratified it [ 146 ]. The main objective of the AMA is to enhance the capacity of States Parties and regional economic communities to regulate medical products to improve the quality, safety, and efficacy of medical products on the continent [ 147 ]. The AMA, in collaboration with other existing capacity building initiatives or organizations, such as the WHO Global Initiative on Digital Health, ITU, AMRH, WHO AFRO, and United Nations Children’s Fund, can assist sub-Saharan African countries in aligning their regulatory requirements with available resources and support them to acquire the necessary tools and skills to build effective and sustainable regulatory systems for health apps. This can be achieved by adopting a decentralized approach to engage a network of technical experts across the African Union similar to the model of the European Medicines Agency [ 148 ].

Actors or Stakeholders

The regulation of health apps often requires working with a wide range of actors or stakeholders. However, in this review, we identified only 2 main actor groups (those who provide digital health services and those who use the ICT infrastructure of the health ministry). These are the groups that are targeted by the included regulatory standards.

From a broader perspective, 12 categories of stakeholders according to their potential role in regulating health apps for the self-management were mapped in this study. The potential contribution of these stakeholders to the regulation of health apps for self-management in sub-Saharan Africa not only depends on their roles and responsibilities but also on their interests, needs, expectations, and influence [ 41 , 149 - 151 ]. Thus, a robust stakeholder analysis is paramount as it can help define the scope of the regulatory process, prioritize the requirements, manage the expectations, and ensure the engagement and participation of stakeholders throughout the regulatory process [ 41 , 152 - 156 ]. Our stakeholder mapping, as presented in Table 2 (refer to Multimedia Appendix 4 for more details), lays the foundation for national governments to conduct a robust stakeholder analysis and to adopt an all-inclusive stakeholder engagement strategy to manage and sustain the engagement and participation of all relevant stakeholders [ 157 , 158 ].

Recommendations

Our review found that the regulation of health apps in sub-Saharan Africa is especially poor and almost nonexistent, as only Kenya has national standards that could address some of the regulatory issues related to health apps. Therefore, we recommend the following actions to help sub-Saharan African countries improve the regulation of health apps to support self-management:

• Establish a clear and consistent definition of what constitutes a health app (considering AI or machine learning) and what level of regulation is required for different types of apps.
• Develop and implement criteria and guidelines that ensure the quality, safety, and usability of health apps.
• Engage with independent app evaluators, such as ORCHA, to adopt a common framework that can guide the evaluation and accreditation of health apps and use the framework to create and maintain decentralized and transparent platforms that showcase and evaluate health apps for users and health care professionals.
• Develop and implement policies and regulations that enable sustainable funding for health apps such as integrating the use of health apps for self-management into existing health systems and financing pathways or mechanisms.
• Support and facilitate innovation and collaboration across the sub-Saharan Africa region, especially in areas including but not limited to data security and privacy, interoperability standards, usability, accessibility, funding, capacity building, and monitoring and evaluation of the regulatory process.
• Manage and sustain the engagement, involvement, and participation of all relevant stakeholders in the regulatory process by conducting a robust stakeholder analysis and adopting an all-inclusive stakeholder engagement strategy.

Strengths and Limitations of the Study

This study has several strengths, which include an extensive search of gray literature and repositories, contact with key individuals, and the use of a systematic approach. Given that regulatory standards and guidance are unavailable in scientific databases, a wide range of gray literature and repositories were searched. In addition, contact was made with key staff members to obtain relevant documents, including those at the MOHs, the WHO country offices, and the WHO AFRO. Second, to enhance the strength of the study, a policy analysis framework was adapted and used to systematically organize the key study findings, whereas a deductive descriptive qualitative content analysis approach was used to identify and analyze texts that contained relevant concepts and other related information based on the 4 predefined themes. Third, the RISA tool was used to guide the mapping of key stakeholders. This has further increased the robustness of the study findings.

The limitations of this study include the fact that our literature search was conducted in English. Although the literature search was conducted in English, it yielded documents written in French and Portuguese from the ICTworks repository. Second, regulatory standards and guidance are not readily available on scientific databases; hence, it is possible that some relevant documents might have been missed. However, efforts were made to obtain these documents by contacting key stakeholders including key contact persons at the WHO AFRO, WHO country offices, and MOHs. In addition, contacting key individuals only for the purposes of requesting documents rather than conducting direct interviews was one of the limitations of this study. Interviewing key contact persons and stakeholders to obtain additional information could have strengthened the review; however, we did not interview any key individuals or stakeholders because it was beyond the scope of this review. Nonetheless, we recommend that future studies consider incorporating interviews to explore the perspectives of key stakeholders.

Conclusions

Health apps are increasingly being used by patients to manage their health, and sub-Saharan African countries can leverage these apps to advance their progress toward achieving SDG 3 (good health and well-being) and UHC, especially given the rapid advancement of AI and big data. However, our study has established that the regulation of health apps in sub-Saharan Africa is inadequate to ensure that health apps are technically reliable and clinically safe; interoperable across systems; compliant with the principles of confidentiality of information and data privacy; culturally appropriate and relevant; and accessible to everyone regardless of gender, ethnicity, location, or income. Therefore, the region can learn from the experiences of some high-income countries such as the United Kingdom and Germany to develop and implement a robust and responsive regulatory system that supports the widespread adoption of safe, effective, and beneficial health apps for its population.

Following the publication of this review, a summary of the findings will be disseminated to the relevant organizations. In addition, the key findings will be summarized and presented at national, regional, and international conferences.

Acknowledgments

The authors would like to thank Rebecca Jones, the Library Manager and Liaison Librarian at Charing Cross Library, who advised and assisted with the search strategy for this study. This work is part of the PhD research of BAB, which is sponsored by the government of Nigeria. AM and JC were supported by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration Northwest London (NIHR200180). The views expressed in this publication are those of the authors and not necessarily those of the government of Nigeria or the NIHR or the Department of Health and Social Care. In the Results and Discussion sections, Microsoft Copilot in Bing [ 159 ] was used to help summarize and modify a few texts as well as suggest some citations.

Data Availability

The search strategy for PubMed, Scopus, and the World Health Organization AIM is presented in Multimedia Appendix 1 . All data generated or analyzed during this study are included in this published article (and its supplementary information files). The documents analyzed are available directly from the relevant institutional websites, ICTworks repository [ 44 ] or upon request from the relevant government departments in each country. Additionally, documents in the list of references that are not accessible on the web can be solicited from the corresponding author on reasonable request.

Authors' Contributions

BAB and JC conceived the study. BAB designed the study with contributions from JC and NM. BAB drafted the manuscript, and JC, NM, AM, SI, KPF, BIH, and NU read and contributed to it. AM was the clinical lead, and JC acted as a guarantor for this study. The final manuscript was read and approved by all the authors.

Conflicts of Interest

None declared.

PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist.

Database search strategy.

Details of included documents.

Mapping of the stakeholders according to their potential role in regulating health apps for self-management.

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Abbreviations

Edited by A Mavragani; submitted 19.05.23; peer-reviewed by N O'Brien, A Essén; comments to author 07.09.23; revised version received 08.12.23; accepted 23.02.24; published 11.04.24.

©Benard Ayaka Bene, Sunny Ibeneme, Kayode Philip Fadahunsi, Bala Isa Harri, Nkiruka Ukor, Nikolaos Mastellos, Azeem Majeed, Josip Car. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 11.04.2024.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.

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Department of Dermatology, K J Somaiya Medical College, Mumbai, Maharashtra, India

Jimish Deepak Bagadia

In an era of information overload, it is important to know how to obtain the required information and also to ensure that it is reliable information. Hence, it is essential to understand how to perform a systematic literature search. This article focuses on reliable literature sources and how to make optimum use of these in dermatology and venereology.

INTRODUCTION

A thorough review of literature is not only essential for selecting research topics, but also enables the right applicability of a research project. Most importantly, a good literature search is the cornerstone of practice of evidence based medicine. Today, everything is available at the click of a mouse or at the tip of the fingertips (or the stylus). Google is often the Go-To search website, the supposed answer to all questions in the universe. However, the deluge of information available comes with its own set of problems; how much of it is actually reliable information? How much are the search results that the search string threw up actually relevant? Did we actually find what we were looking for? Lack of a systematic approach can lead to a literature review ending up as a time-consuming and at times frustrating process. Hence, whether it is for research projects, theses/dissertations, case studies/reports or mere wish to obtain information; knowing where to look, and more importantly, how to look, is of prime importance today.

Literature search

Fink has defined research literature review as a “systematic, explicit and reproducible method for identifying, evaluating, and synthesizing the existing body of completed and recorded work produced by researchers, scholars and practitioners.”[ 1 ]

Review of research literature can be summarized into a seven step process: (i) Selecting research questions/purpose of the literature review (ii) Selecting your sources (iii) Choosing search terms (iv) Running your search (v) Applying practical screening criteria (vi) Applying methodological screening criteria/quality appraisal (vii) Synthesizing the results.[ 1 ]

This article will primarily concentrate on refining techniques of literature search.

Sources for literature search are enumerated in Table 1 .

Sources for literature search

PubMed is currently the most widely used among these as it contains over 23 million citations for biomedical literature and has been made available free by National Center for Biotechnology Information (NCBI), U.S. National Library of Medicine. However, the availability of free full text articles depends on the sources. Use of options such as advanced search, medical subject headings (MeSH) terms, free full text, PubMed tutorials, and single citation matcher makes the database extremely user-friendly [ Figure 1 ]. It can also be accessed on the go through mobiles using “PubMed Mobile.” One can also create own account in NCBI to save searches and to use certain PubMed tools.

PubMed home page showing location of different tools which can be used for an efficient literature search

Tips for efficient use of PubMed search:[ 2 , 3 , 4 ]

Use of field and Boolean operators

When one searches using key words, all articles containing the words show up, many of which may not be related to the topic. Hence, the use of operators while searching makes the search more specific and less cumbersome. Operators are of two types: Field operators and Boolean operators, the latter enabling us to combine more than one concept, thereby making the search highly accurate. A few key operators that can be used in PubMed are shown in Tables ​ Tables2 2 and ​ and3 3 and illustrated in Figures ​ Figures2 2 and ​ and3 3 .

Field operators used in PubMed search

Boolean operators used in PubMed search

PubMed search results page showing articles on donovanosis using the field operator [TIAB]; it shows all articles which have the keyword “donovanosis” in either title or abstract of the article

PubMed search using Boolean operators ‘AND’, ‘NOT’; To search for articles on treatment of lepra reaction other than steroids, after clicking the option ‘Advanced search’ on the home page, one can build the search using ‘AND’ option for treatment and ‘NOT’ option for steroids to omit articles on steroid treatment in lepra reaction

Use of medical subject headings terms

These are very specific and standardized terms used by indexers to describe every article in PubMed and are added to the record of every article. A search using MeSH will show all articles about the topic (or keywords), but will not show articles only containing these keywords (these articles may be about an entirely different topic, but still may contain your keywords in another context in any part of the article). This will make your search more specific. Within the topic, specific subheadings can be added to the search builder to refine your search [ Figure 4 ]. For example, MeSH terms for treatment are therapy and therapeutics.

PubMed search using medical subject headings (MeSH) terms for management of gonorrhea. Click on MeSH database ( Figure 1 ) →In the MeSH search box type gonorrhea and click search. Under the MeSH term gonorrhea, there will be a list of subheadings; therapy, prevention and control, click the relevant check boxes and add to search builder →Click on search →All articles on therapy, prevention and control of gonorrhea will be displayed. Below the subheadings, there are two options: (1) Restrict to medical subject headings (MeSH) major topic and (2) do not include MeSH terms found below this term in the MeSH hierarchy. These can be used to further refine the search results so that only articles which are majorly about treatment of gonorrhea will be displayed

Two additional options can be used to further refine MeSH searches. These are located below the subheadings for a MeSH term: (1) Restrict to MeSH major topic; checking this box will retrieve articles which are majorly about the search term and are therefore, more focused and (2) Do not include MeSH terms found below this term in the MeSH hierarchy. This option will again give you more focused articles as it excludes the lower specific terms [ Figure 4 ].

Similar feature is available with Cochrane library (also called MeSH), EMBASE (known as EMTREE) and PsycINFO (Thesaurus of Psychological Index Terms).

Saving your searches

Any search that one has performed can be saved by using the ‘Send to’ option and can be saved as a simple word file [ Figure 5 ]. Alternatively, the ‘Save Search’ button (just below the search box) can be used. However, it is essential to set up an NCBI account and log in to NCBI for this. One can even choose to have E-mail updates of new articles in the topic of interest.

Saving PubMed searches. A simple option is to click on the dropdown box next to ‘Send to’ option and then choose among the options. It can be saved as a text or word file by choosing ‘File’ option. Another option is the “Save search” option below the search box but this will require logging into your National Center for Biotechnology Information account. This however allows you to set up alerts for E-mail updates for new articles

Single citation matcher

This is another important tool that helps to find the genuine original source of a particular research work (when few details are known about the title/author/publication date/place/journal) and cite the reference in the most correct manner [ Figure 6 ].

Single citation matcher: Click on “Single citation matcher” on PubMed Home page. Type available details of the required reference in the boxes to get the required citation

Full text articles

In any search clicking on the link “free full text” (if present) gives you free access to the article. In some instances, though the published article may not be available free, the author manuscript may be available free of charge. Furthermore, PubMed Central articles are available free of charge.

Managing filters

Filters can be used to refine a search according to type of article required or subjects of research. One can specify the type of article required such as clinical trial, reviews, free full text; these options are available on a typical search results page. Further specialized filters are available under “manage filters:” e.g., articles confined to certain age groups (properties option), “Links” to other databases, article specific to particular journals, etc. However, one needs to have an NCBI account and log in to access this option [ Figure 7 ].

Managing filters. Simple filters are available on the ‘search results’ page. One can choose type of article, e.g., clinical trial, reviews etc. Further options are available in the “Manage filters” option, but this requires logging into National Center for Biotechnology Information account

The Cochrane library

Although reviews are available in PubMed, for systematic reviews and meta-analysis, Cochrane library is a much better resource. The Cochrane library is a collection of full length systematic reviews, which can be accessed for free in India, thanks to Indian Council of Medical Research renewing the license up to 2016, benefitting users all over India. It is immensely helpful in finding detailed high quality research work done in a particular field/topic [ Figure 8 ].

Cochrane library is a useful resource for reliable, systematic reviews. One can choose the type of reviews required, including trials

An important tool that must be used while searching for research work is screening. Screening helps to improve the accuracy of search results. It is of two types: (1) Practical: To identify a broad range of potentially useful studies. Examples: Date of publication (last 5 years only; gives you most recent updates), participants or subjects (humans above 18 years), publication language (English only) (2) methodological: To identify best available studies (for example, excluding studies not involving control group or studies with only randomized control trials).

Selecting the right quality of literature is the key to successful research literature review. The quality can be estimated by what is known as “The Evidence Pyramid.” The level of evidence of references obtained from the aforementioned search tools are depicted in Figure 9 . Systematic reviews obtained from Cochrane library constitute level 1 evidence.

Evidence pyramid: Depicting the level of evidence of references obtained from the aforementioned search tools

Thus, a systematic literature review can help not only in setting up the basis of a good research with optimal use of available information, but also in practice of evidence-based medicine.

Source of Support: Nil.

Conflict of Interest: None declared.