argumentative systematic literature review

Literature Review: Types of Literature Reviews

• Literature Review
• Purpose of a Literature Review
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• Compiling & Writing
• Books, Articles, & Web Pages

Types of Literature Reviews

• Departmental Differences
• Citation Styles & Plagiarism
• Know the Difference! Systematic Review vs. Literature Review

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, opinions, and interpretations that are shared informally that become part of the lore of the 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 embedded 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 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, phenomenon 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 analyze 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, phenomenon. 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 is from The Literature Review created by Dr. Robert Larabee USC

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Types of Literature Review

There are many types of literature review. The choice of a specific type depends on your research approach and design. The following types of literature review are the most popular in business studies:

Narrative literature review , also referred to as traditional literature review, critiques literature and summarizes the body of a literature. Narrative review also draws conclusions about the topic and identifies gaps or inconsistencies in a body of knowledge. You need to have a sufficiently focused research question to conduct a narrative literature review

Systematic literature review requires more rigorous and well-defined approach compared to most other types of literature review. Systematic literature review is comprehensive and details the timeframe within which the literature was selected. Systematic literature review can be divided into two categories: meta-analysis and meta-synthesis.

When you conduct meta-analysis you take findings from several studies on the same subject and analyze these using standardized statistical procedures. In meta-analysis patterns and relationships are detected and conclusions are drawn. Meta-analysis is associated with deductive research approach.

Meta-synthesis, on the other hand, is based on non-statistical techniques. This technique integrates, evaluates and interprets findings of multiple qualitative research studies. Meta-synthesis literature review is conducted usually when following inductive research approach.

Scoping literature review , as implied by its name is used to identify the scope or coverage of a body of literature on a given topic. It has been noted that “scoping reviews are useful for examining emerging evidence when it is still unclear what other, more specific questions can be posed and valuably addressed by a more precise systematic review.” [1] The main difference between systematic and scoping types of literature review is that, systematic literature review is conducted to find answer to more specific research questions, whereas scoping literature review is conducted to explore more general research question.

Argumentative literature review , as the name implies, examines literature selectively in order to support or refute an argument, deeply imbedded assumption, or philosophical problem already established in the literature. It should be noted that a potential for bias is a major shortcoming associated with argumentative literature review.

Integrative literature review reviews , critiques, and synthesizes secondary data about research topic in an integrated way such that new frameworks and perspectives on the topic are generated. If your research does not involve primary data collection and data analysis, then using integrative literature review will be your only option.

Theoretical literature review focuses on a pool of theory that has accumulated in regard to an issue, concept, theory, phenomena. Theoretical literature reviews play an instrumental role in establishing what theories already exist, the relationships between them, to what degree existing theories have been investigated, and to develop new hypotheses to be tested.

At the earlier parts of the literature review chapter, you need to specify the type of your literature review your chose and justify your choice. Your choice of a specific type of literature review should be based upon your research area, research problem and research methods.  Also, you can briefly discuss other most popular types of literature review mentioned above, to illustrate your awareness of them.

[1] Munn, A. et. al. (2018) “Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach” BMC Medical Research Methodology

  John Dudovskiy

Creating Lit Reviews as Arguments

Annette Markham

Jul 1, 2014

I wrote this practical guide for students in 2003. Since various people are still asking about it, I’ll share it here:

• A literature review is a systematic search of scholarly work surrounding and specifically related to the researcher’s interest/project.
• A literature review is also an argument or set of arguments made after reading previous research and theoretical discussions in the area of interest.
• A literature review is, therefore, both the process of searching through scholarly works and the outcome of this search; a written argument by the researcher that justifies his/her research project.
• A literature review helps the researcher determine where to go next by pointing out what has been accomplished in previous studies, or what is missing in previous studies, or what might be a useful or innovative way of cutting into a phenomenon to contribute to the conversation.
• A literature review is NOT a paper that simply overviews, summarizes, or describes previous studies, although all these things must take place as the researcher prepares the literature review.
• The written review should be narrow in focus but your search for literature and your review of literature is not narrow.
• Reviews do not simply describe or summarize, they evaluate.
• The process of creating a review can be inductive or deductive (deductive is recommended if you already have a study in progress):

(A deductive approach implies that you “choose an area of research, read all the relevant studies, and come up with some meaningful way to organize the studies” [University of Washington Psychology Writing Center handout])

(An inductive approach implies that you begin with an argument/point or organizing theme and read related studies]

Value (and therefore quality) of the review relies on:

• Your ability to find a lot of research related to your general area, read through most of this, and incorporate only the most relevant into your literature review.
• Your ability to guide readers through the literature via your perspective and argument
• The level of evaluation versus simple description and/or summary
• Your ability to identify gaps, analyze controversy, posit future research questions, or justify your own study.

General Procedures/Steps:

• Identify general area or specific theme
• Research thoroughly, in various disciplines and sources
• Read for detail, keeping a chart if necessary
• Brainstorm ideas for a way to synthesize the material, creatively move beyond mere summary/synthesis to build your own argument
• Narrow your scope:  Identify and list themes or arguments
• Pose arguments as claims, in the form of declarative sentences
• Organize the themes into a logical pattern
• Write each argument, using major theories and research findings to help you build evidence and arguments
• Write the intro and conclusion last

Questions to ask yourself:

• What specific research question am I seeking to address?
• Am I looking for issues of methodology, theory, policy?
• Do the research articles match my research question?
• Am I looking in the right places?  Enough places?
• Will the reader find my review useful?  Why or why not?
• Have I included or accounted for opposing viewpoints or findings?

Evaluation Questions to ask about each article or author as you read :

• Does this article fit with other research in the area?  how does it differ?
• Does the author account for variation from other researchers and findings?
• Have I identified the major findings of this author?
• What is the theoretical framework, the rhetorical purpose, and the practical perspective f this author?
• Is the author internally consistent?
• Does the author provide enough evidence to support the claims being made?
• Are the sources of evidence appropriate?
• Do the conclusions follow from the evidence or study findings presented?
• Does the methodology match the type of question being asked?

Tips for Excellence

• Do not rely on too few articles
• Use several disciplines and libraries to broaden your findings
• Search widely, using various types of physical and online searches to avoid missing large or vital areas of research
• Keep the topic narrow and strive for depth rather than breadth of coverage….which essentially says, “narrow your research question.”
• Remember that you are building your own argument as a scholar. You are not simply summarizing the field (a good lit review is not a broad sweeping overview of the topic.  It is your argument about a topic using many different authors and articles to support your points)

To aid your reading and comprehension of difficult materials:

• Read easier articles first
• Read previous review articles or even semi-related lit review articles first
• Do not skip difficult, long, or complex articles:  Simply read, re-read, and digest.
• Read carefully, looking for subtle interpretations or explanations of theoretical concepts
• Give yourself adequate time to do all of the above…..the worst case scenario is that your argument is poor and misinforms you and your reader because you didn’t take the time to read carefully.
• Explore unfamiliar ideas and concepts with textbooks, but don’t take textbook knowledge as “truth”—that’s the whole point of your literature review.  (textbooks are like big, too easy to read, very broad literature reviews)

More tips for writing literature reviews (or for writing any good argument)

• Outline (preview) your arguments in the introduction clearly and precisely
• Use headings to separate categories and major arguments
• Revise sentences that indicate subjectivity (we know everything is subjective, but you don’t want to water down argument by using “I feel,” “I think,” or “I believe.”)
• Avoid other tendencies such as overusing pronouns and vague referents.  Be concrete and specific.
• If your claims are not original, that’s fine. Cite the origin(s). Give others credit for their ideas.
• Again, avoid plagiarism; if the idea or statement is not yours, cite your source.
• Paraphrasing is more common than direct quoting in a lit review (not a hard and fast rule).
• Remember that a literature review is not really just a “review.”  It is your argument, which begins with and builds from and moves beyond the stuff you read.

Why write as an argument?

• The argument format of writing encourages you to build claims supported with evidence or reasoning.
• Stating your points as declarative statements (that could be answered true/false on a quiz) can help you discover your own attitudes, believes, and values.
• Demanding good arguments of ourselves will lead to new and better ideas.
• Demanding good arguments of ourselves will expose weaknesses that might lead to better qualifications of, or necessary shifts in our claims.
• Making claims and defending them with reasoning and evidence from the literature forces the level of discussion beyond summary and compels you to take a position.
• Finding the weakness in the evidence or reasoning supporting your own claims may help you identify weaknesses in the literature, which in turn can expose excellent gaps to fill with your own research.

Document created by Annette Markham in 2003. Content supplemented by the following resources.  Please cite me if you’re using or quoting this document.  Please consult these other good guides for more information.

• Univ. of Washington Psychology Writing Center: http://depts.washington.edu/psywc/handouts/litrev.html  (now probably here:  http://www.psych.uw.edu/psych.php#p=339 )
• University of Toronto Health Sciences Writing Centre: http://www.utoronto.ca/hswriting/lit-review.htm (now probably this:  http://www.writing.utoronto.ca/advice/specific-types-of-writing/literature-review )
• University of Wisconsin-Madison Writing Center http://www.wisc.edu/writing/Handbook/ReviewofLiterature.html
• Damer, T.E. (2000). Attacking faulty reasoning. A practical guide to fallacy-free arguments. Belmont, CA: Thomson Wadsworth.

FANTASTIC ARTICLE! Literally, every sentence in this article is informative & useful – I particularly find the “Evaluation Questions to ask about…” most precious…..this is a great resource for research scholars such as myself attempting to create a logical argument of the vast body of literature that we’ve read. THANK YOU!

Thank you so much for the valuable information you have given us. It would be wonderful, if you show us live brief example of argument from real research. Believe me this the difficulty which I am undergoing now because I am preparing my self to study for doctoral degree great many thanks / Sudanese teacher

Wow!!! This is incredible – such a valuable resource. Thank you so much for sharing!

Amazing post! I really appreciate all the information.

thanks for sharing .

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Does argumentation matter? A systematic literature review on the role of argumentation in doctor-patient communication

Affiliation.

• 1 a Institute of Communication & Health , University of Lugano.
• PMID: 24359318
• DOI: 10.1080/10410236.2013.829018

In view of a growing interest in argumentative discourse in the context of patient-centered consultation and shared decision making, this article explores the role that argumentation has been attributed in the literature on doctor-patient consultation so far. It studies to what extent theories and concepts of argumentation have been applied by scholars from various fields in order to analyze, understand, facilitate, and improve the argumentative nature of medical consultation. It reports on an extensive and systematic literature search-using eight online databases, expert suggestions, and a manual search-and the subsequent evaluation of 1,330 abstracts on the basis of strict inclusion and exclusion criteria. Forty relevant scientific contributions are grouped into four main categories and discussed accordingly: (a) argumentation theory, (b) discourse analysis, (c) medical informatics, and (d) medical ethics. Because of its systematic approach, this study forms a solid starting point for further integration of argumentation theoretical insights into contemporary views of patient-centered medicine and evidence-based medicine. It provides suggestions for further interdisciplinary and theory-driven research with a strong focus on empirical reality. Doing so, a preliminary model is proposed that outlines the potential effects of the quality of doctors' communication on proximal, intermediate, and long-term consultation outcomes.

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Writing the Literature Review

Barry Mauer and John Venecek

• The Literature Review

What is the Purpose of the Review?

What is the scope of the review, strategies for getting started, types of literature reviews, composition guidelines, how to locate reviews by discipline, key takeaways.

We also provide the following activities:

Types of Literature Reviews [Refresher]

Writing the literature review [refresher], the literature review [1].

Conducting a literary studies research project involves time and effort, with much of it going towards the development of a literature review . A literature review might fill several pages of your research paper and usually appears soon after an introduction but before you present your detailed argument. A literature review provides your audience with an overview of the available research about your area(s) of study, including the literary work, your theory, and methodology. The literature review demonstrates how these scholarly discussions have changed over time, and it allows you to position your research in relation to research that has come before yours. Your aim is to present the discussion up to this point. Depending on the nature of the assignment, you may also include your critical commentary on prior research, noting among this material the weaker and stronger arguments, breakthroughs and dead ends, blind spots and opportunities, the invention of key terms and methods, mistakes as well as misreadings, and so on.

Once you have gathered the research materials you need for your literature review, you have another task: conducting an analysis on the research to see where your original contribution fits into the scholarly conversation. As the saying goes, “we are standing on the shoulders of giants.” Your job is to show a portrait of these giants to your audience, and to show how your work relates to the portrait. On many scholarly topics, literature reviews already exist. You may refer to such existing reviews within your own, indicating any materials might have been overlooked, new developments that have arisen since the publication of the existing literature review, and new perspectives or insights you have about the materials.

Some beginning researchers try to tear down the work of other researchers in an effort to make their own work look good by comparison. It rarely works. First, it tends to make your audience skeptical of your claims. Second, it ignores the fact that even the mistakes, blind spots, and failures of other researchers contribute something to our knowledge. Albert Einstein didn’t disrespect Sir Isaac Newton by saying Newton’s theory of space was wrong and terrible and that Einstein’s own theory was great by comparison. He built upon Newton’s work, showing how it could be improved. If, however, a researcher willfully set out to deceive or distort or to tear down the work of other scholars without good reason, then their work does not deserve such deference.

Most literature reviews appear after the introduction. It presents your reader with relevant information about the scholarly discussion up to now. Later in your paper, you discuss your contribution. Before you begin work on your literature review, let’s discuss what we mean by “literature”; understand the purpose and scope of the review; establish criteria for selecting, organizing, and interpreting your findings; and discuss how to connect your findings to your research question.

Many students seek to “find sources that agree with my claim or idea.” That approach is too narrow, in our view. If we use such an approach, we may get the following results:

• Because we can find sources that agree with almost any claim, readers will wonder whether your claims are weak and the sources are cherry picked.
• While literary scholars sometimes cite authorities to support their claims, they don’t rely only on authority. They respect authority, but not too much. Your own claims need to rely more on evidence (from the literary text, historical and biographical information), and your critical and creative reasoning skills.
• Scholarship is a conversation; thus, the goal is less about finding agreement and more about joining the conversation with the aim of making a valuable contribution to the discussion.

The literature review provides your reader with an overview of the existing research about your topic or problem. It provides the context necessary for your reader to catch up with the scholarly conversation and then to appreciate the value of your contribution to it. The literature review sharpens the focus of your research and demonstrates your knowledge and understanding of the scholarly conversation around your topic, which, in turn, helps establish your credibility as a researcher.

Creating the literature review involves more than gathering citations. It is a qualitative process through which you will discover what is already known about your topic, and identify the key authorities, methods, and theoretical foundations, so you can begin to position your contributions within the scholarly conversation.

Defining the scope of your review will also help you establish criteria to determine the relevance of the sources you are finding. At this stage, you are not reading in-depth; instead, you are skimming through what has already been published and identifying the major concepts, theories, methodologies, and methods present within these published works. You should also be identifying connections, tensions, and contradictions within the already published works of your topic or problem. This involves building on the knowledge of others and understanding what methods, measures, and models we have inherited from previous researchers in our field.

Literature Reviews: Common Errors Made When Conducting a Literature Review [12 min 22 sec]

Video provided courtesy of the Center for Quality Research (CQR)

A literature review helps your reader understand the relationship of your research project to the work of other scholars. It covers the existing knowledge about a problem, and allows you to show the relevance/significance of your contribution to the discussion. Your reader may or may not have read scholarly literature about the theories, methodologies, and literary works you are discussing. But they want to know that you have read it and have thought about it. Your literature review provides not only a summary of the existing scholarship for readers; it also offers your perspective on it.

Begin your work on the literature review by synthesizing the various sources in your annotated bibliography .

For advice on Synthesizing Sources, consider the following from The Purdue Online Writing Lab: [2]

Note that  synthesizing is not the same as summarizing .

• A summary restates the information in one or more sources without providing new insight or reaching new conclusions.
• A synthesis draws on multiple sources to reach a broader conclusion.
• Don’t force a relationship between sources if there isn’t one. Not all of your sources have to complement one another.
• Do your best to highlight the relationships between sources in very clear ways.
• Don’t ignore any outliers in your research. It’s important to take note of every perspective (even those that disagree with your broader conclusions).

Not all humanities research projects contain literature reviews, but many do. Keep in mind that the type of literature review you choose (see list below) pertains to the secondary research – other scholarly sources – and not to the primary literary work. For instance, a literature review about Kate Chopin’s writing will be your thoughts about the scholarship on Chopin and not about Chopin’s text itself. You are summarizing what you see in the scholarly literature about Chopin’s writing. The literature review puts you in the position of authority not just on Chopin’s writing but on the scholarship about her writing. You are seeking to understand what scholars have said about her work. Scholars might belong to different schools of thought (psychoanalytic, feminist, Marxist, etc.). They might make different arguments about Chopin. They might use different methodological approaches. 

If your research involves two or more theories, such as psychology and genre studies, you may need to create multiple literature reviews, one for each theory or methodology. If the theories overlap with each other significantly (i.e., Marxism and Cultural Studies), you may combine them. Your literature review need not include everything about the subject area – you would need to write a book to cover a single theory – but only those concepts and methods that are most relevant to your research problem.

Factors to Consider When Developing Your Literature Review

• Determine the Scope : How broad or narrow should your literature review be? You may want to focus on recent scholarship only, or on a particular school of thought in the literature. Your scope is determined by your purpose; what is it you aim to achieve with your research?
• Establish Criteria : We discussed the importance of defining the purpose and scope of your review on the previous page, but it’s worth reviewing here as well. This step will help you establish important criteria and focus your searching. For example, how many sources will you need? What types of sources (primary, secondary, statistics, media)? Is currency important? Do you know who the prominent authors or theorists are in your subject area? Take some time to map out these or other important factors before you begin searching journals and databases.
• Consider Your Audience : Unlike a work cited page or an annotated bibliography, both of which are lists of sources, a literature review is essayistic and can be considered a precursor to your final paper. Therefore, it should be written in your own voice, and it should be geared toward a specific audience. Considering audience during this early stage will help focus your final paper as well.
• Find Models : We’ll discuss the different types of literature reviews and how to locate examples in the section below. However, even if you’re undecided about what type of review will work best for you, you may want to review some example literature reviews to get a sense of what they look like before you begin your own.

One piece of advice before starting: look for existing literature reviews on your area of scholarship. You can build on the work that other scholars have put into reviewing the scholarly literature. There’s no need to completely “reinvent the wheel” if some of the work is already done.

Scholars sometimes publish “stand-alone” literature reviews that are not part of a larger work; such literature reviews are valuable contributions to the field, as they summarize the state of knowledge for other scholars.

Maria J. Grant and Andrew Booth’s “A Typology of Reviews” identifies 14 distinct types of literature reviews. Further, the UCLA library created a chart to complement the article and for easy comparison of those 14 types of reviews. This section provides a brief summary of the most common literature reviews. For a more complete analysis, please see the full article and the chart .

To choose the most appropriate structure, put yourself in your reader’s shoes and think through their need for information. The literature review is about providing context for your contribution. How much context do people need? Keep it to the minimum necessary; compressing a lot of information into a small amount of text is a must.

These structures are not meant to be straightjackets but tools to help you organize your research. If you find that the tool is working, then keep using it. If not, switch tools or modify the one you are using. Keep in mind that the types of literature reviews are just different ways of organizing information. So, you can discuss literary trends without organizing your review of secondary literature by trend; your discussion can be organized by theory or theme, for examples. In our literature reviews, we are not recounting other scholars’ arguments at length but merely providing key concepts so we can summarize the discussion so far and position our own claims. You don’t have to adhere strictly to one structure or another. They are just organizing tools that help you manage your material (and help your reader make sense of it).

Types of Reviews

• Traditional or narrative reviews : This approach will generate a comprehensive, critical analysis of the published research on your topic. However, rather than merely compiling as many sources as possible, use this approach to establish a theoretical framework for your paper, establish trends, and identify gaps in the research. This process should bring your research question into clearer focus and help define a thesis that you will argue for in your paper. This is perhaps the most common and general type of literature review. The examples listed below are all designed to serve a more specific purpose.
• Argumentative : The purpose of an argumentative literature review is to select sources for the purpose of supporting or refuting a specific claim. While this type of review can help the author make a strong case for or against an issue, they can also be prone to claims of bias. Later in this textbook, we will read about the distinction between warranted and unwarranted bias . One is ok and the other is not.
• Chronological : A chronological review is used when the author wants to demonstrate the progression of how a theory, methodology, or issue has progressed over time. This method is most effective when there is a clear chronological path to the research about a specific historical event or trend as opposed to a more recursive theoretical concept.
• By trend : This is similar to the chronological approach except it focuses on clearly-defined trends rather than date ranges. This would be most appropriate if you want to illustrate changing perspectives or attitudes about a given issue when specific date ranges are less important than the ebb and flow of the trend.
• Thematic : In this type of literature review, the author will select specific themes that he or she feels are important to understanding a larger topic or concept. Then, the author will organize the sources around those themes, which are often based on relevance or importance. The value of this method is that the process of organizing the review by theme is similar to constructing an argument. This can help the author see how resources connect to each other and determine how as well as why specific sources support their thesis.
• Theoretical : The goal of this type of review is to examine how theory has shaped the research on a given topic. It establishes existing theoretical models, their connections, and how extensively they have been developed in the published research. For example, Jada applied critical race theory to her analysis of Sonny’s Blues , but she might also consider conducting a more comprehensive review of other theoretical frameworks such as feminism, Marxism, or postmodernism. Doing so could provide insight into alternate readings, and help her identify theoretical gaps such as unexplored or under-developed approaches to Baldwin’s work.
• Methodological : The approach focuses on the various methodologies used by researchers in a specific area rather than an analysis of their findings. In this case, you would create a framework of approaches to data collection related to your topic or research question. This is perhaps more common in education or the social and hard sciences where published research often includes a methods section, but it is sometimes appropriate for the digital humanities as well.
• Scoping : The aim of a scoping review is to provide a comprehensive overview or map of the published research or evidence related to a research question. This might be considered a prelude to a systematic review that would take the scoping review one step further toward answering a clearly defined research question. See below for more details.
• Systematic : The systematic review is most appropriate when you have a clearly-defined research question and have established criteria for the types of sources you need. In this way, the systematic review is less exploratory than other types of reviews. Rather, it is comprehensive, strategic, and focused on answering a specific research question. For this reason, the systematic review is more common in the health and social sciences, where comprehensiveness is more important. Literature reviews in the Humanities are not usually exhaustive but tend to show only the most representative or salient developments in the scholarship.
• Meta-analysis : Does your research deal with statistics or large amounts of data? If so, then a meta-analysis might be best for you rather than providing a critical review, the meta-analysis will summarize and synthesize the results of numerous studies that involve statistics or data to provide a more comprehensive picture than would be possible from just one study.

An argumentative literature review presents and takes sides in scholarly arguments about the literary work. It makes arguments about other scholars’ work. It does not necessarily involve a claim that the literary work is itself making an argument. Likewise, a chronological literature review presents the scholarly literature in chronological order.

You don’t need to keep strictly to one type. Scholars often combine features from various types of literature reviews. A sample review that combines the follow types –

• Argumentative
• Theoretical
• Methodological

– is the excellent work of Eiranen, Reetta, Mari Hatavara, Ville Kivimäki, Maria Mäkelä & Raisa Maria Toivo (2022) “ Narrative and Experience: Interdisciplinary Methodologies between History and Narratology , ” Scandinavian Journal of History , 47:1, 1-15

When writing your literature review, please follow these pointers:

• Conduct systematic searches
• Use Evidence
• Be Selective
• Use Quotes Sparingly
• Summarize & Synthesize
• Use Caution when Paraphrasing
• Use Your Own Voice

Advice from James Mason University’s “Literature Reviews: An Overview”

A note on synthesizing : Don’t make the common mistake of summarizing individual studies or articles one after the other. The goal is to synthesize — that is, to make observations about groups of studies. Synthesis often uses language like this:

• Much of the literature on [topic x ] focuses on [major themes].
• In recent years, researchers have begun investigating [facets a , b , and c ] of [topic x ].
• The studies in this review of [topic x ] confirm / suggest / call into question / support [idea / practice / finding / method / theory / guideline y ].
• In the reviewed studies [variable x ] was generally associated with higher / lower rates of [outcome y ].
• A limitation of some / most / all of these studies is [ y ].

Please see this sample annotated literature review  from James Mason University.

Structure of a literature review [2]

• Problematization: The 2 to 3 pages of problematization are a distinct, iterative, step. It may take doing such a statement a few times before moving forward to writing the actual paper.
• Search: Write down your keyword sets, your updated keyword sets, and databases. It is perfectly within a reviewer’s rights to ask for these details.
• Summary: Really getting to know major themes requires some annotation of articles. You want to identify core papers and themes and write about them. This helps you really learn the material. [ChatGPT or Wikipedia are no substitute for deep engagement with a paper.]
• Argument: Either outline or create a slide deck that help you express the arguments in your paper. Read them out loud. Have friends look at them. Present them. [Every literature review has an argument. If not, it’s a summary. A summary does not merit publication in a top outlet.]
• Unpacking: Once you’ve nailed the short pitch, unpack the full argument. [ a) Take time in each major section to map out a) the argument, b) the supporting evidence, and the takeaway. b) Take those major sections, reconcile them, make sure they don’t overlap, then move on to writing. c) Sketch out the paper’s sections, tables, figures, and appendices.]
• Writing: Writing is the easy part. You can always put words to the screen. [Revising and improving is hard. Make time to write every day. Improving requires feedback. Find a writing partner to give feedback. Create your tables and figures. Write to them. Make sure the words in the paper align to the visuals.]
• Communicate: When the paper is done, go back and create a paper presentation. [I do this for the papers that I’m most serious about. The act of storyboarding helps me sort out the small pieces of the story that don’t fit together. If I really want it to succeed, I present it. The act of presenting helps me get it right. My best papers sometimes take seven or eight presentations to get it right. Then I return to the paper and fine tune it. Only then, does it have a shot at a top outlet.]

Literature reviews can be published as part of a scholarly article, often after the introduction and sometimes with a header, but they can also be published as a standalone essay. To find examples of what reviews look like in your discipline, choose an appropriate subject database (such as MLA for literary criticism) and conduct a keyword search with the term “Literature Review” added in quotes:

Not only do these examples demonstrate how to structure different types of literature reviews, but some offer insights into trends and directions for future research. In the next section, we’ll take a closer look at some reading strategies to help guide you through this process.

Since scholars already have produced literature reviews on various scholarly conversations, you don’t always need to “reinvent the wheel” (start a literature review from nothing). You can find a published literature review and update it or amend it; scholars do that all the time. However, you must properly cite work you incorporate from others.

• What types of literature review will you be using for your research project? Why did you make this selection over others? If you haven’t made a selection yet, which types are you considering?
• What specific challenges do you face in following a literature review structure?
• If there are any elements of your assignment that need clarification, please list them.
• What was the most important lesson you learned from this page? What point was confusing or difficult to understand?
• In the “Back Matter” of this book, you will find a page titled “Rubrics.” On that page, we provide a rubric for Creating a Literature Review ↵
• Richard West, Brigham Young University, amended by Jason Thatcher, Temple University - https://www.linkedin.com/posts/jason-thatcher-0329764_academicwriting-topten2023-activity-7146507675021766656-BB0O ↵

Writing the Literature Review Copyright © 2021 by Barry Mauer and John Venecek is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

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Co-creation with ai in b2b markets: a systematic literature review.

1. Introduction

2. artificial intelligence in b2b marketing, 3. co-creation and artificial intelligence, 4. materials and methods, 5.1. descriptive analysis, 5.2. thematic analysis, 5.2.1. co-creation with ai in b2b: actors, motives, and characteristics, 5.2.2. co-creation with ai in b2b: processes, 5.2.3. co-creation with ai in b2b: content, 6. discussion and conclusions, 7. limitations, supplementary materials, author contributions, conflicts of interest.

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Fehrenbach, D.; Herrando, C.; Martín-De Hoyos, M.J. Co-Creation with AI in B2B Markets: A Systematic Literature Review. Sustainability 2024 , 16 , 8009. https://doi.org/10.3390/su16188009

Fehrenbach D, Herrando C, Martín-De Hoyos MJ. Co-Creation with AI in B2B Markets: A Systematic Literature Review. Sustainability . 2024; 16(18):8009. https://doi.org/10.3390/su16188009

Fehrenbach, David, Carolina Herrando, and María José Martín-De Hoyos. 2024. "Co-Creation with AI in B2B Markets: A Systematic Literature Review" Sustainability 16, no. 18: 8009. https://doi.org/10.3390/su16188009

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Title: generative ai for requirements engineering: a systematic literature review.

Abstract: Context: Generative AI (GenAI) has emerged as a transformative tool in software engineering, with requirements engineering (RE) actively exploring its potential to revolutionize processes and outcomes. The integration of GenAI into RE presents both promising opportunities and significant challenges that necessitate systematic analysis and evaluation. Objective: This paper presents a comprehensive systematic literature review (SLR) analyzing state-of-the-art applications and innovative proposals leveraging GenAI in RE. It surveys studies focusing on the utilization of GenAI to enhance RE processes while identifying key challenges and opportunities in this rapidly evolving field. Method: A rigorous SLR methodology was used to analyze 27 carefully selected primary studies in-depth. The review examined research questions pertaining to the application of GenAI across various RE phases, the models and techniques used, and the challenges encountered in implementation and adoption. Results: The most salient findings include i) a predominant focus on the early stages of RE, particularly the elicitation and analysis of requirements, indicating potential for expansion into later phases; ii) the dominance of large language models, especially the GPT series, highlighting the need for diverse AI approaches; and iii) persistent challenges in domain-specific applications and the interpretability of AI-generated outputs, underscoring areas requiring further research and development. Conclusions: The results highlight the critical need for comprehensive evaluation frameworks, improved human-AI collaboration models, and thorough consideration of ethical implications in GenAI-assisted RE. Future research should prioritize extending GenAI applications across the entire RE lifecycle, enhancing domain-specific capabilities, and developing strategies for responsible AI integration in RE practices.

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Lau F, Kuziemsky C, editors. Handbook of eHealth Evaluation: An Evidence-based Approach [Internet]. Victoria (BC): University of Victoria; 2017 Feb 27.

Handbook of eHealth Evaluation: An Evidence-based Approach [Internet].

Chapter 9 methods for literature reviews.

Guy Paré and Spyros Kitsiou .

9.1. Introduction

Literature reviews play a critical role in scholarship because science remains, first and foremost, a cumulative endeavour ( vom Brocke et al., 2009 ). As in any academic discipline, rigorous knowledge syntheses are becoming indispensable in keeping up with an exponentially growing eHealth literature, assisting practitioners, academics, and graduate students in finding, evaluating, and synthesizing the contents of many empirical and conceptual papers. Among other methods, literature reviews are essential for: (a) identifying what has been written on a subject or topic; (b) determining the extent to which a specific research area reveals any interpretable trends or patterns; (c) aggregating empirical findings related to a narrow research question to support evidence-based practice; (d) generating new frameworks and theories; and (e) identifying topics or questions requiring more investigation ( Paré, Trudel, Jaana, & Kitsiou, 2015 ).

Literature reviews can take two major forms. The most prevalent one is the “literature review” or “background” section within a journal paper or a chapter in a graduate thesis. This section synthesizes the extant literature and usually identifies the gaps in knowledge that the empirical study addresses ( Sylvester, Tate, & Johnstone, 2013 ). It may also provide a theoretical foundation for the proposed study, substantiate the presence of the research problem, justify the research as one that contributes something new to the cumulated knowledge, or validate the methods and approaches for the proposed study ( Hart, 1998 ; Levy & Ellis, 2006 ).

The second form of literature review, which is the focus of this chapter, constitutes an original and valuable work of research in and of itself ( Paré et al., 2015 ). Rather than providing a base for a researcher’s own work, it creates a solid starting point for all members of the community interested in a particular area or topic ( Mulrow, 1987 ). The so-called “review article” is a journal-length paper which has an overarching purpose to synthesize the literature in a field, without collecting or analyzing any primary data ( Green, Johnson, & Adams, 2006 ).

When appropriately conducted, review articles represent powerful information sources for practitioners looking for state-of-the art evidence to guide their decision-making and work practices ( Paré et al., 2015 ). Further, high-quality reviews become frequently cited pieces of work which researchers seek out as a first clear outline of the literature when undertaking empirical studies ( Cooper, 1988 ; Rowe, 2014 ). Scholars who track and gauge the impact of articles have found that review papers are cited and downloaded more often than any other type of published article ( Cronin, Ryan, & Coughlan, 2008 ; Montori, Wilczynski, Morgan, Haynes, & Hedges, 2003 ; Patsopoulos, Analatos, & Ioannidis, 2005 ). The reason for their popularity may be the fact that reading the review enables one to have an overview, if not a detailed knowledge of the area in question, as well as references to the most useful primary sources ( Cronin et al., 2008 ). Although they are not easy to conduct, the commitment to complete a review article provides a tremendous service to one’s academic community ( Paré et al., 2015 ; Petticrew & Roberts, 2006 ). Most, if not all, peer-reviewed journals in the fields of medical informatics publish review articles of some type.

The main objectives of this chapter are fourfold: (a) to provide an overview of the major steps and activities involved in conducting a stand-alone literature review; (b) to describe and contrast the different types of review articles that can contribute to the eHealth knowledge base; (c) to illustrate each review type with one or two examples from the eHealth literature; and (d) to provide a series of recommendations for prospective authors of review articles in this domain.

9.2. Overview of the Literature Review Process and Steps

As explained in Templier and Paré (2015) , there are six generic steps involved in conducting a review article:

• formulating the research question(s) and objective(s),
• searching the extant literature,
• screening for inclusion,
• assessing the quality of primary studies,
• extracting data, and
• analyzing data.

Although these steps are presented here in sequential order, one must keep in mind that the review process can be iterative and that many activities can be initiated during the planning stage and later refined during subsequent phases ( Finfgeld-Connett & Johnson, 2013 ; Kitchenham & Charters, 2007 ).

Formulating the research question(s) and objective(s): As a first step, members of the review team must appropriately justify the need for the review itself ( Petticrew & Roberts, 2006 ), identify the review’s main objective(s) ( Okoli & Schabram, 2010 ), and define the concepts or variables at the heart of their synthesis ( Cooper & Hedges, 2009 ; Webster & Watson, 2002 ). Importantly, they also need to articulate the research question(s) they propose to investigate ( Kitchenham & Charters, 2007 ). In this regard, we concur with Jesson, Matheson, and Lacey (2011) that clearly articulated research questions are key ingredients that guide the entire review methodology; they underscore the type of information that is needed, inform the search for and selection of relevant literature, and guide or orient the subsequent analysis. Searching the extant literature: The next step consists of searching the literature and making decisions about the suitability of material to be considered in the review ( Cooper, 1988 ). There exist three main coverage strategies. First, exhaustive coverage means an effort is made to be as comprehensive as possible in order to ensure that all relevant studies, published and unpublished, are included in the review and, thus, conclusions are based on this all-inclusive knowledge base. The second type of coverage consists of presenting materials that are representative of most other works in a given field or area. Often authors who adopt this strategy will search for relevant articles in a small number of top-tier journals in a field ( Paré et al., 2015 ). In the third strategy, the review team concentrates on prior works that have been central or pivotal to a particular topic. This may include empirical studies or conceptual papers that initiated a line of investigation, changed how problems or questions were framed, introduced new methods or concepts, or engendered important debate ( Cooper, 1988 ). Screening for inclusion: The following step consists of evaluating the applicability of the material identified in the preceding step ( Levy & Ellis, 2006 ; vom Brocke et al., 2009 ). Once a group of potential studies has been identified, members of the review team must screen them to determine their relevance ( Petticrew & Roberts, 2006 ). A set of predetermined rules provides a basis for including or excluding certain studies. This exercise requires a significant investment on the part of researchers, who must ensure enhanced objectivity and avoid biases or mistakes. As discussed later in this chapter, for certain types of reviews there must be at least two independent reviewers involved in the screening process and a procedure to resolve disagreements must also be in place ( Liberati et al., 2009 ; Shea et al., 2009 ). Assessing the quality of primary studies: In addition to screening material for inclusion, members of the review team may need to assess the scientific quality of the selected studies, that is, appraise the rigour of the research design and methods. Such formal assessment, which is usually conducted independently by at least two coders, helps members of the review team refine which studies to include in the final sample, determine whether or not the differences in quality may affect their conclusions, or guide how they analyze the data and interpret the findings ( Petticrew & Roberts, 2006 ). Ascribing quality scores to each primary study or considering through domain-based evaluations which study components have or have not been designed and executed appropriately makes it possible to reflect on the extent to which the selected study addresses possible biases and maximizes validity ( Shea et al., 2009 ). Extracting data: The following step involves gathering or extracting applicable information from each primary study included in the sample and deciding what is relevant to the problem of interest ( Cooper & Hedges, 2009 ). Indeed, the type of data that should be recorded mainly depends on the initial research questions ( Okoli & Schabram, 2010 ). However, important information may also be gathered about how, when, where and by whom the primary study was conducted, the research design and methods, or qualitative/quantitative results ( Cooper & Hedges, 2009 ). Analyzing and synthesizing data : As a final step, members of the review team must collate, summarize, aggregate, organize, and compare the evidence extracted from the included studies. The extracted data must be presented in a meaningful way that suggests a new contribution to the extant literature ( Jesson et al., 2011 ). Webster and Watson (2002) warn researchers that literature reviews should be much more than lists of papers and should provide a coherent lens to make sense of extant knowledge on a given topic. There exist several methods and techniques for synthesizing quantitative (e.g., frequency analysis, meta-analysis) and qualitative (e.g., grounded theory, narrative analysis, meta-ethnography) evidence ( Dixon-Woods, Agarwal, Jones, Young, & Sutton, 2005 ; Thomas & Harden, 2008 ).

9.3. Types of Review Articles and Brief Illustrations

EHealth researchers have at their disposal a number of approaches and methods for making sense out of existing literature, all with the purpose of casting current research findings into historical contexts or explaining contradictions that might exist among a set of primary research studies conducted on a particular topic. Our classification scheme is largely inspired from Paré and colleagues’ (2015) typology. Below we present and illustrate those review types that we feel are central to the growth and development of the eHealth domain.

9.3.1. Narrative Reviews

The narrative review is the “traditional” way of reviewing the extant literature and is skewed towards a qualitative interpretation of prior knowledge ( Sylvester et al., 2013 ). Put simply, a narrative review attempts to summarize or synthesize what has been written on a particular topic but does not seek generalization or cumulative knowledge from what is reviewed ( Davies, 2000 ; Green et al., 2006 ). Instead, the review team often undertakes the task of accumulating and synthesizing the literature to demonstrate the value of a particular point of view ( Baumeister & Leary, 1997 ). As such, reviewers may selectively ignore or limit the attention paid to certain studies in order to make a point. In this rather unsystematic approach, the selection of information from primary articles is subjective, lacks explicit criteria for inclusion and can lead to biased interpretations or inferences ( Green et al., 2006 ). There are several narrative reviews in the particular eHealth domain, as in all fields, which follow such an unstructured approach ( Silva et al., 2015 ; Paul et al., 2015 ).

Despite these criticisms, this type of review can be very useful in gathering together a volume of literature in a specific subject area and synthesizing it. As mentioned above, its primary purpose is to provide the reader with a comprehensive background for understanding current knowledge and highlighting the significance of new research ( Cronin et al., 2008 ). Faculty like to use narrative reviews in the classroom because they are often more up to date than textbooks, provide a single source for students to reference, and expose students to peer-reviewed literature ( Green et al., 2006 ). For researchers, narrative reviews can inspire research ideas by identifying gaps or inconsistencies in a body of knowledge, thus helping researchers to determine research questions or formulate hypotheses. Importantly, narrative reviews can also be used as educational articles to bring practitioners up to date with certain topics of issues ( Green et al., 2006 ).

Recently, there have been several efforts to introduce more rigour in narrative reviews that will elucidate common pitfalls and bring changes into their publication standards. Information systems researchers, among others, have contributed to advancing knowledge on how to structure a “traditional” review. For instance, Levy and Ellis (2006) proposed a generic framework for conducting such reviews. Their model follows the systematic data processing approach comprised of three steps, namely: (a) literature search and screening; (b) data extraction and analysis; and (c) writing the literature review. They provide detailed and very helpful instructions on how to conduct each step of the review process. As another methodological contribution, vom Brocke et al. (2009) offered a series of guidelines for conducting literature reviews, with a particular focus on how to search and extract the relevant body of knowledge. Last, Bandara, Miskon, and Fielt (2011) proposed a structured, predefined and tool-supported method to identify primary studies within a feasible scope, extract relevant content from identified articles, synthesize and analyze the findings, and effectively write and present the results of the literature review. We highly recommend that prospective authors of narrative reviews consult these useful sources before embarking on their work.

Darlow and Wen (2015) provide a good example of a highly structured narrative review in the eHealth field. These authors synthesized published articles that describe the development process of mobile health (m-health) interventions for patients’ cancer care self-management. As in most narrative reviews, the scope of the research questions being investigated is broad: (a) how development of these systems are carried out; (b) which methods are used to investigate these systems; and (c) what conclusions can be drawn as a result of the development of these systems. To provide clear answers to these questions, a literature search was conducted on six electronic databases and Google Scholar . The search was performed using several terms and free text words, combining them in an appropriate manner. Four inclusion and three exclusion criteria were utilized during the screening process. Both authors independently reviewed each of the identified articles to determine eligibility and extract study information. A flow diagram shows the number of studies identified, screened, and included or excluded at each stage of study selection. In terms of contributions, this review provides a series of practical recommendations for m-health intervention development.

9.3.2. Descriptive or Mapping Reviews

The primary goal of a descriptive review is to determine the extent to which a body of knowledge in a particular research topic reveals any interpretable pattern or trend with respect to pre-existing propositions, theories, methodologies or findings ( King & He, 2005 ; Paré et al., 2015 ). In contrast with narrative reviews, descriptive reviews follow a systematic and transparent procedure, including searching, screening and classifying studies ( Petersen, Vakkalanka, & Kuzniarz, 2015 ). Indeed, structured search methods are used to form a representative sample of a larger group of published works ( Paré et al., 2015 ). Further, authors of descriptive reviews extract from each study certain characteristics of interest, such as publication year, research methods, data collection techniques, and direction or strength of research outcomes (e.g., positive, negative, or non-significant) in the form of frequency analysis to produce quantitative results ( Sylvester et al., 2013 ). In essence, each study included in a descriptive review is treated as the unit of analysis and the published literature as a whole provides a database from which the authors attempt to identify any interpretable trends or draw overall conclusions about the merits of existing conceptualizations, propositions, methods or findings ( Paré et al., 2015 ). In doing so, a descriptive review may claim that its findings represent the state of the art in a particular domain ( King & He, 2005 ).

In the fields of health sciences and medical informatics, reviews that focus on examining the range, nature and evolution of a topic area are described by Anderson, Allen, Peckham, and Goodwin (2008) as mapping reviews . Like descriptive reviews, the research questions are generic and usually relate to publication patterns and trends. There is no preconceived plan to systematically review all of the literature although this can be done. Instead, researchers often present studies that are representative of most works published in a particular area and they consider a specific time frame to be mapped.

An example of this approach in the eHealth domain is offered by DeShazo, Lavallie, and Wolf (2009). The purpose of this descriptive or mapping review was to characterize publication trends in the medical informatics literature over a 20-year period (1987 to 2006). To achieve this ambitious objective, the authors performed a bibliometric analysis of medical informatics citations indexed in medline using publication trends, journal frequencies, impact factors, Medical Subject Headings (MeSH) term frequencies, and characteristics of citations. Findings revealed that there were over 77,000 medical informatics articles published during the covered period in numerous journals and that the average annual growth rate was 12%. The MeSH term analysis also suggested a strong interdisciplinary trend. Finally, average impact scores increased over time with two notable growth periods. Overall, patterns in research outputs that seem to characterize the historic trends and current components of the field of medical informatics suggest it may be a maturing discipline (DeShazo et al., 2009).

9.3.3. Scoping Reviews

Scoping reviews attempt to provide an initial indication of the potential size and nature of the extant literature on an emergent topic (Arksey & O’Malley, 2005; Daudt, van Mossel, & Scott, 2013 ; Levac, Colquhoun, & O’Brien, 2010). A scoping review may be conducted to examine the extent, range and nature of research activities in a particular area, determine the value of undertaking a full systematic review (discussed next), or identify research gaps in the extant literature ( Paré et al., 2015 ). In line with their main objective, scoping reviews usually conclude with the presentation of a detailed research agenda for future works along with potential implications for both practice and research.

Unlike narrative and descriptive reviews, the whole point of scoping the field is to be as comprehensive as possible, including grey literature (Arksey & O’Malley, 2005). Inclusion and exclusion criteria must be established to help researchers eliminate studies that are not aligned with the research questions. It is also recommended that at least two independent coders review abstracts yielded from the search strategy and then the full articles for study selection ( Daudt et al., 2013 ). The synthesized evidence from content or thematic analysis is relatively easy to present in tabular form (Arksey & O’Malley, 2005; Thomas & Harden, 2008 ).

One of the most highly cited scoping reviews in the eHealth domain was published by Archer, Fevrier-Thomas, Lokker, McKibbon, and Straus (2011) . These authors reviewed the existing literature on personal health record ( phr ) systems including design, functionality, implementation, applications, outcomes, and benefits. Seven databases were searched from 1985 to March 2010. Several search terms relating to phr s were used during this process. Two authors independently screened titles and abstracts to determine inclusion status. A second screen of full-text articles, again by two independent members of the research team, ensured that the studies described phr s. All in all, 130 articles met the criteria and their data were extracted manually into a database. The authors concluded that although there is a large amount of survey, observational, cohort/panel, and anecdotal evidence of phr benefits and satisfaction for patients, more research is needed to evaluate the results of phr implementations. Their in-depth analysis of the literature signalled that there is little solid evidence from randomized controlled trials or other studies through the use of phr s. Hence, they suggested that more research is needed that addresses the current lack of understanding of optimal functionality and usability of these systems, and how they can play a beneficial role in supporting patient self-management ( Archer et al., 2011 ).

9.3.4. Forms of Aggregative Reviews

Healthcare providers, practitioners, and policy-makers are nowadays overwhelmed with large volumes of information, including research-based evidence from numerous clinical trials and evaluation studies, assessing the effectiveness of health information technologies and interventions ( Ammenwerth & de Keizer, 2004 ; Deshazo et al., 2009 ). It is unrealistic to expect that all these disparate actors will have the time, skills, and necessary resources to identify the available evidence in the area of their expertise and consider it when making decisions. Systematic reviews that involve the rigorous application of scientific strategies aimed at limiting subjectivity and bias (i.e., systematic and random errors) can respond to this challenge.

Systematic reviews attempt to aggregate, appraise, and synthesize in a single source all empirical evidence that meet a set of previously specified eligibility criteria in order to answer a clearly formulated and often narrow research question on a particular topic of interest to support evidence-based practice ( Liberati et al., 2009 ). They adhere closely to explicit scientific principles ( Liberati et al., 2009 ) and rigorous methodological guidelines (Higgins & Green, 2008) aimed at reducing random and systematic errors that can lead to deviations from the truth in results or inferences. The use of explicit methods allows systematic reviews to aggregate a large body of research evidence, assess whether effects or relationships are in the same direction and of the same general magnitude, explain possible inconsistencies between study results, and determine the strength of the overall evidence for every outcome of interest based on the quality of included studies and the general consistency among them ( Cook, Mulrow, & Haynes, 1997 ). The main procedures of a systematic review involve:

• Formulating a review question and developing a search strategy based on explicit inclusion criteria for the identification of eligible studies (usually described in the context of a detailed review protocol).
• Searching for eligible studies using multiple databases and information sources, including grey literature sources, without any language restrictions.
• Selecting studies, extracting data, and assessing risk of bias in a duplicate manner using two independent reviewers to avoid random or systematic errors in the process.
• Analyzing data using quantitative or qualitative methods.
• Presenting results in summary of findings tables.
• Interpreting results and drawing conclusions.

Many systematic reviews, but not all, use statistical methods to combine the results of independent studies into a single quantitative estimate or summary effect size. Known as meta-analyses , these reviews use specific data extraction and statistical techniques (e.g., network, frequentist, or Bayesian meta-analyses) to calculate from each study by outcome of interest an effect size along with a confidence interval that reflects the degree of uncertainty behind the point estimate of effect ( Borenstein, Hedges, Higgins, & Rothstein, 2009 ; Deeks, Higgins, & Altman, 2008 ). Subsequently, they use fixed or random-effects analysis models to combine the results of the included studies, assess statistical heterogeneity, and calculate a weighted average of the effect estimates from the different studies, taking into account their sample sizes. The summary effect size is a value that reflects the average magnitude of the intervention effect for a particular outcome of interest or, more generally, the strength of a relationship between two variables across all studies included in the systematic review. By statistically combining data from multiple studies, meta-analyses can create more precise and reliable estimates of intervention effects than those derived from individual studies alone, when these are examined independently as discrete sources of information.

The review by Gurol-Urganci, de Jongh, Vodopivec-Jamsek, Atun, and Car (2013) on the effects of mobile phone messaging reminders for attendance at healthcare appointments is an illustrative example of a high-quality systematic review with meta-analysis. Missed appointments are a major cause of inefficiency in healthcare delivery with substantial monetary costs to health systems. These authors sought to assess whether mobile phone-based appointment reminders delivered through Short Message Service ( sms ) or Multimedia Messaging Service ( mms ) are effective in improving rates of patient attendance and reducing overall costs. To this end, they conducted a comprehensive search on multiple databases using highly sensitive search strategies without language or publication-type restrictions to identify all rct s that are eligible for inclusion. In order to minimize the risk of omitting eligible studies not captured by the original search, they supplemented all electronic searches with manual screening of trial registers and references contained in the included studies. Study selection, data extraction, and risk of bias assessments were performed inde­­pen­dently by two coders using standardized methods to ensure consistency and to eliminate potential errors. Findings from eight rct s involving 6,615 participants were pooled into meta-analyses to calculate the magnitude of effects that mobile text message reminders have on the rate of attendance at healthcare appointments compared to no reminders and phone call reminders.

Meta-analyses are regarded as powerful tools for deriving meaningful conclusions. However, there are situations in which it is neither reasonable nor appropriate to pool studies together using meta-analytic methods simply because there is extensive clinical heterogeneity between the included studies or variation in measurement tools, comparisons, or outcomes of interest. In these cases, systematic reviews can use qualitative synthesis methods such as vote counting, content analysis, classification schemes and tabulations, as an alternative approach to narratively synthesize the results of the independent studies included in the review. This form of review is known as qualitative systematic review.

A rigorous example of one such review in the eHealth domain is presented by Mickan, Atherton, Roberts, Heneghan, and Tilson (2014) on the use of handheld computers by healthcare professionals and their impact on access to information and clinical decision-making. In line with the methodological guide­lines for systematic reviews, these authors: (a) developed and registered with prospero ( www.crd.york.ac.uk/ prospero / ) an a priori review protocol; (b) conducted comprehensive searches for eligible studies using multiple databases and other supplementary strategies (e.g., forward searches); and (c) subsequently carried out study selection, data extraction, and risk of bias assessments in a duplicate manner to eliminate potential errors in the review process. Heterogeneity between the included studies in terms of reported outcomes and measures precluded the use of meta-analytic methods. To this end, the authors resorted to using narrative analysis and synthesis to describe the effectiveness of handheld computers on accessing information for clinical knowledge, adherence to safety and clinical quality guidelines, and diagnostic decision-making.

In recent years, the number of systematic reviews in the field of health informatics has increased considerably. Systematic reviews with discordant findings can cause great confusion and make it difficult for decision-makers to interpret the review-level evidence ( Moher, 2013 ). Therefore, there is a growing need for appraisal and synthesis of prior systematic reviews to ensure that decision-making is constantly informed by the best available accumulated evidence. Umbrella reviews , also known as overviews of systematic reviews, are tertiary types of evidence synthesis that aim to accomplish this; that is, they aim to compare and contrast findings from multiple systematic reviews and meta-analyses ( Becker & Oxman, 2008 ). Umbrella reviews generally adhere to the same principles and rigorous methodological guidelines used in systematic reviews. However, the unit of analysis in umbrella reviews is the systematic review rather than the primary study ( Becker & Oxman, 2008 ). Unlike systematic reviews that have a narrow focus of inquiry, umbrella reviews focus on broader research topics for which there are several potential interventions ( Smith, Devane, Begley, & Clarke, 2011 ). A recent umbrella review on the effects of home telemonitoring interventions for patients with heart failure critically appraised, compared, and synthesized evidence from 15 systematic reviews to investigate which types of home telemonitoring technologies and forms of interventions are more effective in reducing mortality and hospital admissions ( Kitsiou, Paré, & Jaana, 2015 ).

9.3.5. Realist Reviews

Realist reviews are theory-driven interpretative reviews developed to inform, enhance, or supplement conventional systematic reviews by making sense of heterogeneous evidence about complex interventions applied in diverse contexts in a way that informs policy decision-making ( Greenhalgh, Wong, Westhorp, & Pawson, 2011 ). They originated from criticisms of positivist systematic reviews which centre on their “simplistic” underlying assumptions ( Oates, 2011 ). As explained above, systematic reviews seek to identify causation. Such logic is appropriate for fields like medicine and education where findings of randomized controlled trials can be aggregated to see whether a new treatment or intervention does improve outcomes. However, many argue that it is not possible to establish such direct causal links between interventions and outcomes in fields such as social policy, management, and information systems where for any intervention there is unlikely to be a regular or consistent outcome ( Oates, 2011 ; Pawson, 2006 ; Rousseau, Manning, & Denyer, 2008 ).

To circumvent these limitations, Pawson, Greenhalgh, Harvey, and Walshe (2005) have proposed a new approach for synthesizing knowledge that seeks to unpack the mechanism of how “complex interventions” work in particular contexts. The basic research question — what works? — which is usually associated with systematic reviews changes to: what is it about this intervention that works, for whom, in what circumstances, in what respects and why? Realist reviews have no particular preference for either quantitative or qualitative evidence. As a theory-building approach, a realist review usually starts by articulating likely underlying mechanisms and then scrutinizes available evidence to find out whether and where these mechanisms are applicable ( Shepperd et al., 2009 ). Primary studies found in the extant literature are viewed as case studies which can test and modify the initial theories ( Rousseau et al., 2008 ).

The main objective pursued in the realist review conducted by Otte-Trojel, de Bont, Rundall, and van de Klundert (2014) was to examine how patient portals contribute to health service delivery and patient outcomes. The specific goals were to investigate how outcomes are produced and, most importantly, how variations in outcomes can be explained. The research team started with an exploratory review of background documents and research studies to identify ways in which patient portals may contribute to health service delivery and patient outcomes. The authors identified six main ways which represent “educated guesses” to be tested against the data in the evaluation studies. These studies were identified through a formal and systematic search in four databases between 2003 and 2013. Two members of the research team selected the articles using a pre-established list of inclusion and exclusion criteria and following a two-step procedure. The authors then extracted data from the selected articles and created several tables, one for each outcome category. They organized information to bring forward those mechanisms where patient portals contribute to outcomes and the variation in outcomes across different contexts.

9.3.6. Critical Reviews

Lastly, critical reviews aim to provide a critical evaluation and interpretive analysis of existing literature on a particular topic of interest to reveal strengths, weaknesses, contradictions, controversies, inconsistencies, and/or other important issues with respect to theories, hypotheses, research methods or results ( Baumeister & Leary, 1997 ; Kirkevold, 1997 ). Unlike other review types, critical reviews attempt to take a reflective account of the research that has been done in a particular area of interest, and assess its credibility by using appraisal instruments or critical interpretive methods. In this way, critical reviews attempt to constructively inform other scholars about the weaknesses of prior research and strengthen knowledge development by giving focus and direction to studies for further improvement ( Kirkevold, 1997 ).

Kitsiou, Paré, and Jaana (2013) provide an example of a critical review that assessed the methodological quality of prior systematic reviews of home telemonitoring studies for chronic patients. The authors conducted a comprehensive search on multiple databases to identify eligible reviews and subsequently used a validated instrument to conduct an in-depth quality appraisal. Results indicate that the majority of systematic reviews in this particular area suffer from important methodological flaws and biases that impair their internal validity and limit their usefulness for clinical and decision-making purposes. To this end, they provide a number of recommendations to strengthen knowledge development towards improving the design and execution of future reviews on home telemonitoring.

9.4. Summary

Table 9.1 outlines the main types of literature reviews that were described in the previous sub-sections and summarizes the main characteristics that distinguish one review type from another. It also includes key references to methodological guidelines and useful sources that can be used by eHealth scholars and researchers for planning and developing reviews.

Typology of Literature Reviews (adapted from Paré et al., 2015).

As shown in Table 9.1 , each review type addresses different kinds of research questions or objectives, which subsequently define and dictate the methods and approaches that need to be used to achieve the overarching goal(s) of the review. For example, in the case of narrative reviews, there is greater flexibility in searching and synthesizing articles ( Green et al., 2006 ). Researchers are often relatively free to use a diversity of approaches to search, identify, and select relevant scientific articles, describe their operational characteristics, present how the individual studies fit together, and formulate conclusions. On the other hand, systematic reviews are characterized by their high level of systematicity, rigour, and use of explicit methods, based on an “a priori” review plan that aims to minimize bias in the analysis and synthesis process (Higgins & Green, 2008). Some reviews are exploratory in nature (e.g., scoping/mapping reviews), whereas others may be conducted to discover patterns (e.g., descriptive reviews) or involve a synthesis approach that may include the critical analysis of prior research ( Paré et al., 2015 ). Hence, in order to select the most appropriate type of review, it is critical to know before embarking on a review project, why the research synthesis is conducted and what type of methods are best aligned with the pursued goals.

9.5. Concluding Remarks

In light of the increased use of evidence-based practice and research generating stronger evidence ( Grady et al., 2011 ; Lyden et al., 2013 ), review articles have become essential tools for summarizing, synthesizing, integrating or critically appraising prior knowledge in the eHealth field. As mentioned earlier, when rigorously conducted review articles represent powerful information sources for eHealth scholars and practitioners looking for state-of-the-art evidence. The typology of literature reviews we used herein will allow eHealth researchers, graduate students and practitioners to gain a better understanding of the similarities and differences between review types.

We must stress that this classification scheme does not privilege any specific type of review as being of higher quality than another ( Paré et al., 2015 ). As explained above, each type of review has its own strengths and limitations. Having said that, we realize that the methodological rigour of any review — be it qualitative, quantitative or mixed — is a critical aspect that should be considered seriously by prospective authors. In the present context, the notion of rigour refers to the reliability and validity of the review process described in section 9.2. For one thing, reliability is related to the reproducibility of the review process and steps, which is facilitated by a comprehensive documentation of the literature search process, extraction, coding and analysis performed in the review. Whether the search is comprehensive or not, whether it involves a methodical approach for data extraction and synthesis or not, it is important that the review documents in an explicit and transparent manner the steps and approach that were used in the process of its development. Next, validity characterizes the degree to which the review process was conducted appropriately. It goes beyond documentation and reflects decisions related to the selection of the sources, the search terms used, the period of time covered, the articles selected in the search, and the application of backward and forward searches ( vom Brocke et al., 2009 ). In short, the rigour of any review article is reflected by the explicitness of its methods (i.e., transparency) and the soundness of the approach used. We refer those interested in the concepts of rigour and quality to the work of Templier and Paré (2015) which offers a detailed set of methodological guidelines for conducting and evaluating various types of review articles.

To conclude, our main objective in this chapter was to demystify the various types of literature reviews that are central to the continuous development of the eHealth field. It is our hope that our descriptive account will serve as a valuable source for those conducting, evaluating or using reviews in this important and growing domain.

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• Cite this Page Paré G, Kitsiou S. Chapter 9 Methods for Literature Reviews. In: Lau F, Kuziemsky C, editors. Handbook of eHealth Evaluation: An Evidence-based Approach [Internet]. Victoria (BC): University of Victoria; 2017 Feb 27.
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FRSB HOSTS GROUNDBREAKING WORKSHOP ON SYSTEMATIC LITERATURE REVIEW FOR HIGH-IMPACT JOURNALS

Dr Sarah Abdulkareem Salih

SRI SERDANG, 14 th  August 2024 - On 14 and 15 August 2024, the Faculty of Design and Architecture (FRSB) at Universiti Putra Malaysia (UPM) marked a significant milestone by hosting one of the first workshops on Systematic Literature Review entitled “HOW TO WRITE AND PUBLISH SYSTEMATIC LITERATURE REVIEW IN HIGH IMPACT JOURNAL.” The workshop aimed to train researchers to conduct and prepare a Systematic Literature Review (SLR) and/or Scoping Review (SR) from A to Z for high-impact journal publication. This pioneering workshop was not only focused on the intricacies of SLR but also delved into various other types of literature reviews, including Scoping Reviews (SR), relevant for journal article publication, thesis writing, and survey tool development. The workshop was a collaborative effort organized by the PUTRA DESIGN NUCLEUS (PDN) team, led by Dr Mohd Fabian Hasna and miss NurFitriah Mohamad Norwan, and speaker Dr Sarah Abdulkareem Salih, a faculty member with experience in SLR and SR methodologies 

This event was a landmark for FRSB as it was one of the first to comprehensively address the entire process of conducting a Systematic Literature Review (SLR), including the steps involved, the development of a review protocol, and the utilization of specialized software tools.Held at the FRSB Seminar Hall, the workshop spanned two full days, from 8 am to 5 pm, offering an intensive yet rewarding experience for the participants. The event attracted a diverse group of 42 participants from over 13 different academic fields, including management education, multimedia systems, landscape and urban planning, architecture and design, integrated design, computer research, food security, modern language and communication, mass communication, health science and medicine, clinical psychology, clinical nutrition, and environmental biotechnology. Among the attendees were an Associate Professor, a member of the UPM library staff, and 40 graduate students pursuing Master’s and Ph.D. degrees.The first day of the workshop introduced participants to the fundamental concepts of SLR, SR, and literature review methodologies. We provided a thorough overview of how to conduct both SLR and SR from start to finish. The day was packed with practical demonstrations, including a session on how to conduct the SLR utilizing UPM's extensive databases and how to effectively use Mendeley Desktop for managing references, which is crucial for organizing and conducting comprehensive literature reviews. I have guided the participants through the process of downloading, installing, and effectively using Mendeley Desktop to streamline their review process. By the end of the day, participants had gained a solid understanding of how to approach SLR and SR, equipped with the tools necessary to conduct thorough and systematic research.

The second day was equally intensive, focusing on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a gold standard in systematic review methodology. Participants were guided through the practical steps of implementing PRISMA in their research, learning how to prepare a well-structured SLR draft suitable for submission to high-impact journals. The workshop also offered invaluable tips on how to navigate the often daunting process of getting these reviews published, emphasizing the importance of meticulousness and adherence to guidelines. Most importantly, the workshop was designed to be highly interactive, with participants encouraged to ask questions and engage in discussions, which further enriched their learning experience. In addition to the formal sessions, I shared my personal experiences and best practices for writing and publishing different types of SLR and SR. This personalized  touch added significant value to the workshop, as participants were able to gain insights from real-world examples and apply them to their own work. The workshop concluded with a closing ceremony attended by FRSB Dean, Associate Professor Ts. Gs. Dr. Mohd Johari Mohd Yusof; who rewarded the participants with a certificate of participation and commended the initiative and the participants' dedication. The event was not just an academic exercise; it was a collaborative and community-building effort. Undoubtedly, the participants were served a delicious breakfast and lunch that were specially prepared for the attendees. The success of the workshop was evident not only in the number of participants but also in the high level of interaction and engagement throughout the two days. The enthusiasm and commitment of the participants were clear, as many requested additional sessions for further discussion and personalized tutoring. In response to this demand, a follow-up session was organized on August 21, where participants had the opportunity to share their preliminary research results and discuss them in depth with me and their peers. This session, held from 9 am to 3 pm, provided a valuable platform for participants to receive feedback and refine their SLR approaches  This workshop stands as a testament to FRSB’s commitment to fostering a culture of high-quality research and publication among its students and faculty. By equipping participants with a comprehensive, hands-on learning experience on systematic reviews, the workshop has not only enhanced the participants' research capabilities but also fostered continuous improvement within our academic community. We hope that this workshop will contribute to cutting-edge research training that meets the evolving needs of the academic community in UPM and Malaysia that FRSB is committed to continuing to provide.

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Efficacy and Safety of Somapacitan Relative to Somatrogon and Lonapegsomatropin in Pediatric Growth Hormone Deficiency: Systematic Literature Review and Network Meta-analysis

• Original Research
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• Published: 11 September 2024

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• Lasse de Fries Jensen   ORCID: orcid.org/0000-0003-3511-2822 1 ,
• Vasileios Antavalis 2 ,
• Jan Odgaard-Jensen 1 ,
• Annachiara Rossi 1 ,
• Alberto Pietropoli 3 &
• Michael Højby 1  

Introduction

Since direct comparisons of long-acting growth hormones (LAGHs) are lacking, analyses were performed to indirectly compare the efficacy and safety of somapacitan versus somatrogon and lonapegsomatropin in children with growth hormone deficiency (GHD).

A systematic literature review (SLR) identified studies of once-weekly LAGHs for the treatment of pediatric GHD. Indirect comparisons (ICs) using a Bayesian hierarchical network meta-analysis and a random effects model were performed using daily growth hormone (GH) 0.034 mg/kg/day (base case) or 0.024–0.034 mg/kg/day (alternative analyses) as the common comparator to compare height outcomes to 52 weeks [annualized height velocity, height velocity standard deviation score (SDS), and height SDS]. Identified evidence did not allow IC of safety or longer-term efficacy outcomes so these were qualitatively described.

The SLR identified two somapacitan trials, three somatrogon trials (one included in alternative analyses only), and one lonapegsomatropin trial comparing the LAGH with daily GH in treatment-naïve pre-pubertal children for IC. ICs revealed no differences at 52 weeks between somapacitan versus somatrogon and lonapegsomatropin, as well as daily GH, with respect to all growth outcomes considered in children with GHD. All three LAGHs had sustained efficacy and were generally well tolerated, with comparable efficacy and safety to daily GH, with the exception of observed injection site pain for somatrogon.

No efficacy and safety differences were identified in comparisons of once weekly somapacitan versus somatrogon and lonapegsomatropin, as well as daily GH. All treatments were generally well tolerated, with the exception of observed injection site pain for somatrogon.

Plain Language Summary

It is valuable to compare similarly acting treatments to determine their relative benefits and risks. Direct comparisons of long-acting growth hormones (LAGHs) are lacking, so analyses were performed to indirectly compare the efficacy and safety of the LAGH somapacitan versus the LAGHs somatrogon and lonapegsomatropin in children with growth hormone deficiency. Studies of once-weekly LAGHs for the treatment of pediatric growth hormone deficiency were identified using a systematic literature review, then the data obtained were indirectly compared using standard statistical methods with daily growth hormone 0.034 mg/kg/day (base case) or 0.024–0.034 mg/kg/day (alternative analyses) as the common comparator. Height outcomes to 52 weeks (annualized height velocity, height velocity standard deviation score, and height standard deviation score) were compared between treatments. Sufficient information to allow indirect comparison of safety or longer-term efficacy outcomes were not found so these were qualitatively described. The systematic literature review identified two somapacitan trials, three somatrogon trials (one included in alternative analyses only) and one lonapegsomatropin trial comparing the LAGH with daily growth hormone in previously untreated pre-pubertal children for inclusion in the indirect comparison. Indirect comparisons identified no differences to 52 weeks between somapacitan versus somatrogon and lonapegsomatropin, as well as daily growth hormone, with respect to all growth outcomes considered in children with growth hormone deficiency. All three LAGHs had sustained efficacy and were generally well tolerated, with comparable efficacy and safety to daily growth hormone, with the possible exception of injection site pain with somatrogon.

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Growth hormone deficiency (GHD) is a rare disorder characterized by inadequate production or secretion of growth hormone (GH) from the anterior pituitary gland; GHD results in reduced longitudinal growth and development during childhood [ 1 , 2 ]. GH replacement in GHD can often restore normal growth in the child, thereby allowing them to reach the final height that would be expected [within two standard deviation scores (SDS) of the expected mean] taking into account parents’ height and other factors; however, it traditionally requires daily injections of GH [ 3 , 4 ].

Long-acting growth hormone (LAGH) formulations that do not need to be administered daily have been developed to offer minimal disruption and potentially improve treatment adherence compared to daily GH; these have been shown to provide similar efficacy and safety to daily GH in children with GHD [ 5 ]. Three once-weekly LAGHs with United States Food and Drug and European Medicines Agency approval for pediatric use, somapacitan (Sogroya ® ; Novo Nordisk), somatrogon (Ngenla™; Pfizer), and lonapegsomatropin (Skytrofa ® ; Ascendis Pharma) have been compared with daily GH in clinical trials but have not been directly compared with each other. The three LAGH formulations utilize different mechanisms to achieve their long-acting pharmacokinetics [ 6 ]; however, it is not known if these differences affect their efficacy or safety.

To allow comparison of these three LAGHs, a systematic literature review (SLR) and indirect comparisons (ICs) were performed firstly to identify evidence on the efficacy and safety of LAGH for the treatment of pediatric GHD and secondly to provide evidence on the comparative efficacy and safety of somapacitan relative to somatrogon and lonapegsomatropin. The focus is comparisons of height outcomes [annualized height velocity (AHV), height velocity SDS, and height SDS] for children with GHD; additionally, safety is considered.

Electronic searches of Embase (from 1974), MEDLINE (from 1946), and the Cochrane Library databases were conducted via the Ovid platform in October 2021 and supplemented with hand-searches of relevant conference proceedings, previous health technology assessment (HTA) agency websites, clinical trial registries, websites of government/international bodies, other supplementary sources, and reference lists of included studies to identify studies describing the efficacy and safety of LAGHs in children with GHD (and no other growth disorders); updates were conducted in May 2022 and March 2023. Predefined search terms and strings captured literature concerning GHD in children or adolescents receiving a LAGH in a randomized controlled trial (RCT), single-arm trial, or observational study. Study selection criteria were defined in terms of population, interventions, comparisons, outcomes, and study design (PICOS) (Table  1 ).

Results from the electronic database searches were downloaded into a bespoke database, and de-duplicated. All identified citations were reviewed based on title/abstract, where available, by two independent reviewers to assess whether they met the PICOS selection criteria. In cases where it was not clear from the title/abstract if a paper was relevant, full publications of studies considered potentially relevant were obtained and examined by two independent reviewers. Full papers were examined by two independent reviewers (second pass), and final inclusion and exclusion of citations were verified by all researchers. Data from the SLR were extracted into a data extraction table, mainly as numerical data, by a single analyst, and quality checked by a second analyst. Disputes were referred to a third party.

Quality assessment of studies, published in full, included in the SLR were conducted by a single statistician. Quality (risk of bias) assessment of included RCTs was conducted using the National Institute for Health and Care Excellence (NICE) checklist [ 7 ]. Quality assessment of the single-arm studies (included in the comparison of safety and/or long-term efficacy) was conducted using the Effective Public Health Practice Project quality assessment tool [ 8 ].

Indirect Comparisons

The planned ICs were conducted in two parts: Part 1 utilized evidence from RCTs lasting at least 26 weeks; Part 2 utilized evidence from trial extensions. Overall, ICs assessing short-term efficacy outcomes were determined to be feasible. However, evidence from extensions beyond 52 weeks, which could be used to assess long-term outcomes, was limited to single arms, so it was not considered feasible to conduct ICs for long-term efficacy outcomes; therefore, these were qualitatively described and are reported in the Supplementary Material. The current ICs aimed to explore specifically the relative efficacy of approved LAGH preparations, somapacitan versus somatrogon and somapacitan versus lonapegsomatropin, in pediatric GHD.

RCTs identified in the SLR were eligible for the ICs if they satisfied the IC-specific PICOS criteria summarized in Table  1 . The main efficacy outcomes of interest for the ICs were height outcomes (AHV, height velocity SDS, height SDS) because they were considered to have the most patient relevance and tend to be primary and key secondary endpoints in GHD clinical trials at 26 and 52 weeks. Bone age was not included as it did not meet these criteria and available data were not assessed by the same central x-ray reader(s), as would be needed to avoid limited and potentially misleading results due to the risk of significant inter-variability in x-ray readings. Availability of data in the included clinical trials is summarized in Table  2 .

Base case analyses utilized trials that included daily GH as the comparator at a dose of 0.034 mg/kg/day (the dose of daily GH used in the trials of somapacitan); alternative analyses included all trials with daily GH at any labeling dose for pediatric GHD (0.024–0.034 mg/kg/day).

The safety of the three LAGHs in comparison with daily GH was summarized, in terms of adverse events (AEs), serious AEs, severe AEs, injection site reactions (ISRs), and antibody development, using data from all available studies identified in the SLR.

Statistical Methods

Network meta-analysis model.

The ICs used a Bayesian hierarchical network meta-analysis (NMA) to estimate the differences in efficacy between somapacitan and somatrogon, and somapacitan and lonapegsomatropin, conducted in accordance with guidelines set by the NICE Decision Support Unit [ 9 ]. All analyses were of continuous outcomes [mean (standard error; SE) AHV, mean (SE) height velocity SDS, mean (SE) change from baseline in height SDS] and were performed using a normal likelihood, identity link model.

A normal distribution for the mean change from baseline or mean value in arm k in trial i, \({{\varvec{y}}}_{{\varvec{i}}{\varvec{k}}}\) with change variance \({{\varvec{V}}}_{{\varvec{i}}{\varvec{k}}}\) was assumed, such that:

The parameter of interest was the mean \({{\varvec{\theta}}}_{{\varvec{i}}{\varvec{k}}}\) which was unconstrained on the real line. An identity link was used and therefore the linear predictor was such that:

where \({{\varvec{\mu}}}_{{\varvec{i}}}\) was the trial-specific intercept in trial i and \({{\varvec{\delta}}}_{{\varvec{i}}{\varvec{j}}{\varvec{k}}}\) were the trial-specific treatment effect of treatment in arm k relative to control treatment in arm j.

Study-level effect sizes were considered exchangeable across comparisons, i.e.,:

where \({{\varvec{d}}}_{{\varvec{j}}{\varvec{k}}}\) is the NMA estimate of the effect size for intervention k relative to intervention j. In the consistency model:

where t denotes another arbitrary intervention in the model. In the random-effects model, study-level effect sizes were considered exchangeable across comparisons, and the trial-specific treatment effects come from a common distribution (as per Eq.  3 ). The fixed-effect model was a special case of the model described in Eq.  (3) , with \({{\varvec{\sigma}}}^{2}=0\) , where σ was the between-trial standard deviation (SD). This assumed homogeneity of the underlying true treatment effects.

The programming language R (version 4.3.1) was used for implementation. Analyses were conducted utilizing function nma in version 0.5.0 of the publicly available package multinma [ 10 ]. Four chains of 10,000 iterations were run: 5000 for burn-in and 5000 for sampling. Default package values were used for thinning and initial values. For convergence, target average proposal acceptance was set to 0.99.

The base case model consisted of all relevant RCTs identified following application of the PICOS statement (Table  1 ) to studies identified in the SLR except for the somatrogon trial in Japanese children (NCT03874013) [ 11 ], which was included only in an alternative analysis, as it evaluated daily GH at a different dose from that used in the somapacitan studies (0.025 mg/kg/day, rather than 0.034 mg/kg/day). In trials with multiple doses of the same LAGH treatment, only the recommended or intended dose range was used for analysis. All formulations of daily GH used in the studies were considered to have equivalent efficacy as per NICE guidance [ 12 ], and in the base case network, all arms where the daily GH dose was 0.034 mg/kg/day were pooled. In the alternative network, the somatrogon trial in Japanese children (NCT03874013) [ 11 ] was connected through the somatrogon node. The approximately 30% reduction in daily GH dose (from 0.034 to 0.025 mg/kg/day) was evaluated to be too great for the treatments to be considered similar so both the relative treatment difference versus the daily GH 0.034 mg/kg/day dose and the 0.025 mg/kg/day dose were presented. The base case and alternative evidence networks are summarized in Fig.  1 .

Base case and alternative evidence network for the indirect comparisons of somapacitan versus somatrogon and lonapegsomatropin. Nodes shown in light gray are included only in the alternative evidence network. GH growth hormone

All trials reported mean change from baseline for height SDS, so no additional data transformation was needed. For height velocity SDS, post hoc analyses on somapacitan trials were conducted to align with reported outcomes in other trials. Since different measures of uncertainty were reported across the trials, SDs and confidence intervals were transformed to standard errors (SEs), respecting the normal distribution of all the variables.

Fixed effect and random effect models with different priors (informative, non-informative) for heterogeneity were performed for each outcome. Choice of model was evaluated on the model fit as measured by the deviance information criteria [ 13 ], the assessment of residual deviance, and the convergence of the models. The random effects model was found to have the better fit (data not shown), so it was used for the reported analyses. Results were presented as median treatment differences with an associated 95% credible interval (CrI). Additionally, for each endpoint in the base case network, a plot of relative treatment estimates with the associated 95% CrI were created.

Assessment of Model Assumptions

Homogeneity was assessed by an assessment of differences in trial designs, with a review of all included trial design characteristics, specifically inclusion and exclusion criteria, treatment and comparator dosing, blinding, and randomization. In addition, the three outcomes of interest reported across the trials, as well as the method of analyses utilized, were assessed. Finally, baseline characteristics, including prognostic factors, were compared graphically across trials. Transitivity (similarity of patients included are sufficiently similar in the two sets of common comparator-controlled trials) was assessed to allow the assumption that relative treatment effects were exchangeable between different treatment comparisons of a network. No formal assessment of consistency was performed since the network contained no loops.

Prior Distributions

The prior represents the prior probability distribution; a vague prior contains no information about the parameters of interest. Vague priors were used for the study-specific treatment effect \({\mu }_{I}\) and treatment effect sizes relative to reference \({d}_{1k}\) in the form of a normal distribution with a mean of 0 and a variance of 10,000, as recommended by NICE [ 13 ].

Due to the size of the network and limited trial replication, vague priors were not used for between-trial heterogeneity in the random effects model. Instead, information that all the daily GH products are bioequivalent and the LAGHs share a mode of action was taken into account, and a prior was calculated through a class-level meta-analysis with random effects, for each endpoint. The estimated between-trial variability ( τ ) was then used as a prior for between-trial SD ( σ ) in the treatment-level random-effect models for the endpoint.

Sensitivity Analysis

AHV analyses for the base case network were conducted using informative priors based on a random effects class model. A sensitivity analysis was performed using expert elicited priors. One expert provided data for these priors. Both analyses are consistent with the approaches used in the NICE evaluation assessment group report.

Ethical Considerations

This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors. Ethical approval was not needed to reuse this information.

A total of 279 titles were identified; after de-duplication, 221 citations were screened for inclusion and a total of 28 publications describing 10 unique studies were included in the SLR (Fig.  2 ). In total, the SLR included five publications reporting findings from one Phase III and one Phase II trial investigating the efficacy and safety of once-weekly somapacitan compared with daily GH in treatment-naïve pre-pubertal children; 12 publications describing two unique Phase III trials (one was not included in the base case analyses, but was included in the alternative analyses) and one Phase II trial reporting the safety and efficacy of somatrogon compared with daily GH in treatment naïve pre-pubertal children with GHD; and nine publications reported findings from three Phase III trials and one Phase II trial investigating safety and efficacy of lonapegsomatropin compared with daily GH in either treatment-naïve (two studies) or -experienced (one study) children with GHD. The third lonapegsomatropin Phase III trial was a long-term uncontrolled extension study with treatment-naïve and previously GH-treated children with GHD from the other two Phase III trials.

PRISMA flow diagram for SLR and studies included in ICs of somapacitan versus somatrogon and lonapegsomatropin. a Some of the unique studies identified in the updates had been identified in the original review and thus may not count as unique trials when combining numbers from all three reviews. The total number of unique studies included one study of eftansomatropin, which was not included in the ICs. b The fliGHt lonapegsomatropin study [ 22 ] was excluded from the IC because it was a single arm study in treatment-experienced patients but was included in the safety analyses; enliGHten (lonapegsomatropin) was included in the long-term assessment of efficacy and safety only [ 34 , 35 ]; NCT01947907 was excluded from the IC because it did not evaluate the recommended dose of lonapegsomatropin but was included in the safety analyses [ 21 ]. c One somatrogon study [ 11 , 14 ] was included only in the alternative analyses, not the base case analyses. IC indirect comparison, SLR systematic literature review

Supplementary Table 1 summarizes the included studies evaluating somapacitan, somatrogon, and lonapegsomatropin compared with daily GH. Quality assessment of the RCTs showed that all studies reported baseline characteristics, and cohorts within each study presented with similar key prognostic factors; there were no unexpected imbalances between the cohorts of each study. Overall, there was no evidence of a selection bias as participants were representative of the target population. Additionally, some of the studies employed interactive Web response technology systems to randomize participants, thus lowering the risk of allocation bias. Similarly, the two single-arm studies included in the safety and long-term efficacy analyses included populations that seemed representative of the target population and there were no differences in key demographic characteristics at baseline; both were considered to be of good quality. A summary of the quality assessment is illustrated in Supplementary Fig. 1.

Indirect Comparisons of Efficacy

Studies included in the two ICs are summarized in Table  2 . Overall, where data were reported, baseline characteristics identified as potential prognostic factors (age, gender, race, height parameters, and peak GH level) were generally balanced across treatment arms in the various trials. However, some differences were observed (Table  3 ). In addition, dose reduction based on insulin-like growth factor-I (IGF-I) was handled differently across various trials, with the extent of reduction varying, along with the thresholds and ways of confirming the original value, and differing sampling times (peak, trough, or mean) for IGF-I levels between trials. Nevertheless, study design characteristics were comparable in terms of inclusion criteria, blinding, and randomization, so it was presumed that the assumption of transitivity was met. The outcomes of interest (AHV, height velocity SDS, and height SDS) are standard outcomes in the disease area, and there were no key differences in outcome definitions across the different trials. In addition, when reported, the analysis of continuous endpoints was generally similar across trials, with most trials considering treatment, age, sex, peak GH level, region, and height as covariates in their analyses.

Annualized Height Velocity

Data on AHV were available from all six trials at weeks 26 and 52 (Table  4 ). There were generally no observed differences in improvements in AHV with somapacitan, somatrogon, and lonapegsomatropin at weeks 26 and 52 compared to daily GH. The results of the base case IC did not reveal any differences in AHV when somapacitan was compared with daily GH, somatrogon, or lonapegsomatropin at weeks 26 and 52 (Fig.  3 a).

Forest plots of results of a base-case and b alternative evidence analyses for the indirect comparisons of somapacitan versus somatrogon and lonapegsomatropin. Crl credible interval, GH growth hormone, SDS standard deviation score

In the alternative analysis, the point estimate for the difference in AHV improvement favoring somapacitan was larger versus low-dose daily GH (0.025 mg/kg/day) than versus standard dose of daily GH, both at weeks 26 and 52. The comparisons between somapacitan and the other comparators showed similar findings to those observed in the base case analysis (Fig.  3 b).

Height Velocity SDS

Data on height velocity SDS were available from two and four trials at weeks 26 and 52, respectively; a network model for week 26 data was not feasible (Table  5 ). Overall, there were generally no observed differences in improvements in height velocity SDS with somapacitan, somatrogon, and lonapegsomatropin at weeks 26 and 52 compared to daily GH. The results of the base case IC did not reveal any differences in height velocity SDS when somapacitan was compared with daily GH, somatrogon, or lonapegsomatropin at week 52 (Fig.  3 a).

The Japanese study [ 11 , 14 ] did not provide height velocity SDS data, so alternative analyses were not performed.

Data on height SDS were available from all six trials at weeks 26 and 52 (Table  6 ). Overall, there was generally no observed difference in improvements in change from baseline in height SDS with somapacitan, somatrogon, and lonapegsomatropin at weeks 26 and 52 compared to daily GH. The results of the base case IC did not reveal any differences in change from baseline in height SDS when somapacitan was compared with daily GH, somatrogon, or lonapegsomatropin at weeks 26 and 52 (Fig.  3 a).

In the alternative analysis, the point estimate for the change from baseline in height SDS favoring somapacitan was larger versus low-dose daily GH (0.025 mg/kg/day) than versus standard dose daily GH, at week 52. The comparisons between somapacitan and the other comparators showed similar findings to those observed in the base case analysis (Fig.  3 b).

Long-Term Efficacy

Long-term efficacy findings are summarized in the Supplementary Material. Overall, results from all study extension phases showed somapacitan, somatrogon, and lonapegsomatropin had sustained efficacy after continued treatment (Supplementary Table 2).

Sensitivity analysis results using alternative priors showed similar findings for AHV to the base case analyses at both weeks 26 and 52 (Supplementary Fig. 2).

Adverse Events to 1 Year

AE data were available to 1 year for somapacitan [ 15 , 16 ], somatrogon [ 17 , 18 , 19 ], and lonapegsomatropin [ 20 ], and to 6 months for lonapegsomatropin in two studies excluded from the efficacy ICs [ 21 , 22 ]. Across all trials, the three LAGHs were generally well tolerated and demonstrated comparable safety to daily GH. Most AEs were mild to moderate in severity. The proportion of patients experiencing at least one AE in 26 and 52 weeks of treatment varied across trials from 46 to 100% (Table  7 ).

When ISRs were considered, variability was observed across clinical trials, perhaps as a result of slight differences in the methods used for determining the frequency of injection site pain, although these variations are unlikely to explain the differences observed (Table  7 ). The rates of injection site AEs and pain were low in all somapacitan trials, with a similar incidence reported in the somapacitan and daily GH arms. Similarly, in lonapegsomatropin trials, there was no difference in incidence of injection site AEs or pain between the lonapegsomatropin and daily GH arms. However, the incidence of injection site pain was higher with somatrogon compared with daily GH across trials of somatrogon.

The incidences of non-neutralizing antidrug antibodies and neutralizing antibodies were reported across trials, with neutralizing antibodies reported infrequently and only with somatrogon. Where reported, analyses from trials showed the presence of antidrug antibodies did not have any effect on efficacy or safety.

No neutralizing anti-human GH (hGH) antibodies were detected in any of the somapacitan trials. One patient (7.1%) treated with daily GH had persistent non-neutralizing anti-hGH antibodies of low titer, and two patients (14.2%) treated with somapacitan 0.16 mg/kg/week had a single transient measurement of low-titer, non-neutralizing antibodies in the Phase II REAL 3 trial [ 15 ]. In the Phase III REAL 4 trial [ 16 ], two patients (1.5%) treated with somapacitan and one patient (1.5%) treated with daily GH had ≥ 2 consecutive positive non-neutralizing antidrug antibodies samples.

In trials of somatrogon, two patients (14.3%) treated with somatrogon 0.66 mg/kg/week and one (9.1%) patient treated with daily GH had non-neutralizing antidrug antibodies in NCT01592500 [ 17 ], whereas 84 patients (77.1%) treated with somatrogon 0.66 mg/kg/week and 18 (15.6%) treated with daily GH tested positive for non-neutralizing antidrug antibodies in NCT02968004 [ 18 ]. In the Japanese trial of somatrogon, 18 patients (81.8%) treated with somatrogon 0.66 mg/kg/week, and four (18.2%) treated with daily GH tested positive for non-neutralizing antidrug antibodies; two patients (9.1%) treated with somatrogon tested positive for neutralizing antibodies at one visit [ 11 ].

No neutralizing anti-hGH antibodies were detected in any of the lonapegsomatropin trials (6- or 12-months’ duration). A low incidence of non-neutralizing antibodies (0–8.3%) was reported across all doses of lonapegsomatropin at 26 and 52 weeks with minimal variability between trials. In the Phase III heiGHt trial, a low titer of anti-hGH binding antibodies were detected in seven (6.7%) patients treated with 0.24 mg/kg/week lonapegsomatropin and two (3.6%) patients treated with 0.24 mg/kg/week daily GH; detected antibodies did not appear to affect safety or efficacy [ 20 ]. In NCT01947907, across the three lonapegsomatropin doses (0.14, 0.21, and 0.3 mg/kg/week) over 26 weeks, only one patient (8.3%) in the 0.14 mg/kg/week group had very low-titer non-neutralizing anti-GH antibodies and no neutralizing antibodies [ 21 ]. There were no neutralizing or non-neutralizing antibodies detected in the 13 patients treated with daily GH 0.21 mg/kg/week for 26 weeks.

Long-Term Adverse Events

Safety data were not consistently reported in publications of the extension periods/studies. Overall, continued treatment with somapacitan and somatrogon was well tolerated, with no new safety signals identified in the extension trials. No long-term safety data for lonapegsomatropin were identified, although it was stated that the drug had an acceptable safety profile in the longer-term. The proportion of patients experiencing at least one AE with somapacitan and somatrogon ranged from approximately 40% to 80% ( Supplementary Table 3 ). Most reported AEs were mild to moderate in severity, and severe AEs were reported infrequently.

Although varying proportions of patients receiving daily GH or lonapegsomatropin tested positive for non-neutralizing antibodies (< 25%), no neutralizing antibodies were detected in either of the long-term somapacitan or lonapegsomatropin studies. In contrast, 17 patients (35.4%) had low titers of anti-somatrogon antibodies, none of whom had neutralizing antibodies, and 84 (77%) had antidrug antibodies, of whom two tested positive for neutralizing antibodies, in the extension period of NCT01592500 [ 23 ] and NCT02968004 [ 24 ]. Where reported, analyses indicated that the presence of antibodies did not have any impact with respect to efficacy outcomes.

Direct comparisons of LAGH for the treatment of pediatric GHD are lacking. The short-term (≤ 52 weeks) comparative efficacy of somapacitan versus somatrogon and lonapegsomatropin were therefore summarized and assessed via IC for this indication. The analyses did not identify any differences in the improvements in AHV, height velocity SDS, and height SDS compared with age- and sex-matched children seen in clinical trials of somapacitan, somatrogon, and lonapegsomatropin, as well as daily GH. These results are in general agreement with another IC of LAGHs conducted by Schaible and colleagues [ 25 ], which found similar AHV and changes in height SDS with somatrogon versus lonapegsomatropin and daily GH using Phase III data only. The restriction to Phase III data in that IC was to try to reduce heterogeneity, but GHD is a rare disease and few studies—predominantly with small sample sizes—are available, so heterogeneity remained high. A fixed effects model was used in the base case of the IC of Schaible and colleagues [ 25 ]. In contrast, a random effects model was used in the current ICs to account for heterogeneity potentially introduced by the additional studies, an approach supported by the NICE evaluation assessment group.

Additionally, the LAGHs were found to have sustained efficacy after continued long-term treatment in the current review: mean AHV results generally reflected a sustained growth rate, while changes in height SDS values reflected height normalization over time. Where reported, results were similar among patients who switched from daily GH to somapacitan, somatrogon, or lonapegsomatropin versus continued treatment with the respective LAGH. Although IC was not considered feasible, descriptive analyses supported that the three LAGHs generally demonstrated similar long-term efficacy.

The safety outcomes considered included AEs, ISRs, and anti-hGH antibodies/antidrug antibodies. Across trials, somapacitan, somatrogon, and lonapegsomatropin were generally well tolerated and demonstrated comparable overall safety to daily GH. Most AEs were mild to moderate in severity in the short and longer term. However, in the somapacitan and lonapegsomatropin trials to 52 weeks, injection site pain reported with similar frequency with the LAGH and daily GH, but, in the somatrogon trials to 52 weeks, injection site pain was more commonly reported with the LAGH than with daily GH, possibly because of reporting practices [ 26 ]. For example, in somatrogon trials [ 11 , 18 ], injection site pain was recorded weekly, capturing each once-weekly somatrogon injection, but for daily GH was recorded as the most severe pain for the week rather than after each daily GH injection, so, even if there were multiple occurrences of severe pain, only one occurrence would be recorded per week. The same difficulty in comparing rates across arms within this trial should also be extended to comparing rates across trials. Nonetheless, injection site pain was reported infrequently in trials of somapacitan, variably in lonapegsomatropin trials, and at a high frequency in somatrogon trials. These differences could have resulted from the volume of each injection, preservatives in buffer solution, needle size, or other needle features; however, they are an important consideration when using GH for pediatric use since injection site pain is one of the major factors influencing compliance [ 27 ].

IGF-I levels were measured in all three pivotal LAGH trials and the same assay was used to measure IGF-I and to quantify IGF-I SDS [ 16 , 18 , 20 ]. However, only the heiGHt trial [ 20 ] found a statistically significant difference in the IGF-I level between the LAGH (lonapegsomatropin) and the daily GH comparator. In the context of the known dose–response relationship between GH and IGF-I SDS, achievement of similar IGF-I SDS and clinical outcomes in a non-inferiority setting confirms the comparable titration of treatment groups and the clinical relevance of findings when interpreting data.

The rates of detected anti-hGH antibodies or antidrug antibodies varied across the trials, with rates being considerably higher in the somatrogon trials than in trials of the other two LAGHs; additionally, neutralizing antibodies were observed with somatrogon but not with somapacitan, lonapegsomatropin, or daily GH. Where reported in the studies included in the current analyses, subjects who were positive for antibodies did not experience reduced efficacy or safety issues compared with those without antibodies. Similarly, additional analyses of a Phase III trial of somatrogon also found the presence of antidrug antibodies to have no effect on the incidence of AEs, and no association between the incidence of AEs and antidrug antibody titer [ 19 ].

The current analyses did not reveal any differences with respect to efficacy between the different technologies used to prolong the action of GH: somapacitan is a GH with reversible non-covalent albumin-binding properties, somatrogon is a GH-fusion protein moiety, and lonapegsomatropin utilizes covalent or transient pegylation [ 6 ]. Additionally, no differences in efficacy and safety between the three LAGHs (somapacitan, somatrogon, and lonapegsomatropin) and daily GH were found, with the possible exception of injection site pain with somatrogon. Therefore, LAGHs which are administered once weekly are expected to reduce the burden and distress associated with daily injections, decrease interference with daily life, and thereby potentially improve treatment adherence and, consequently, clinical outcomes in children with GHD. These assumptions are supported by several analyses of preference and treatment burden conducted in children treated with once-weekly LAGH after switching from daily GH and/or their parents/caregivers. In REAL-4, 90% of parents/caregivers preferred once-weekly somapacitan over daily GH, usually because of the reduced injection frequency [ 28 ]. Additional results of this study suggested lower treatment burden with somapacitan [ 16 ]. In the fliGHt trial, > 80% of children and their parents/caregivers preferred lonapegsomatropin, again mainly because of the reduced injection frequency, and, overall, children and their parents/caregivers had a reduced treatment burden following the switch from daily GH [ 29 ].

Another important factor to consider when selecting a GH treatment is the administrative device and dosing options. For example, somapacitan and somatrogon have pen devices with options to fine tune the dose, whereas the lonapegsomatropin pen device has pre-loaded cartridges which limit the flexibility of dosing.

Limitations

The SLR captured only studies written in English, so potentially relevant studies written in other languages may have been missed, and it has the limitations associated with all SLRs. That is, possible publication bias (study findings may influence investigators’ decision to publish trial findings), time-lag bias (studies with less positive findings take longer to publish), language bias (non-English language articles reporting significant results are more likely to be rewritten in English), and selective outcome reporting (non-significant outcomes are excluded from publication).

The main limitation of the IC was the small number of relevant trials, with a number not fully published, and the lack of trial replication, which limited the information on heterogeneity in the network. In the random effects models, this necessitated the use of more informative priors for between-trial heterogeneity. An attempt was made to leverage the shared mode of action of the various GHs to calculate an appropriate prior, but the same data were used to both calculate the prior and to update it, and the former was not taken from an alternative external source. However, hierarchal class effects models have been used for HTA submissions to explore treatment effects as a class [ 30 ]. In addition, the identified studies predominantly included small numbers of patients, as expected for analyses of rare diseases. Imbalance in prognostic factors (such as age, race, and gender) between arms in the trials was limited and adjusted, since they were used as covariates in the statistical analyses. However, although there were differences between the trials for these prognostic factors, no effect modification was expected, and this was not considered a severe limitation. Furthermore, height SDS and height velocity SDS are standardized for age and gender. The differences in handling of dose reduction (e.g., daily GH vs. once-weekly treatment, based on IGF-I levels across trials) also had potential to impact outcomes, suggesting caution is needed when interpreting results.

For the alternative network, a different dose of daily GH in one of the trials was not adjusted for through dose–response modeling but was connected as a separate treatment. Although a dose–response relationship for daily GH in GHD has been identified [ 31 , 32 ], the small size of the network meant that a meta-regression was deemed unfeasible.

ICs, feasible only for short-term efficacy outcomes (≤ 52 weeks), identified no differences between somapacitan versus somatrogon and lonapegsomatropin with respect to AHV, height velocity SDS, and change in height SDS in children with GHD. One LAGH (lonapegsomatropin) was associated with an elevated IGF-I level compared to daily GH. All three LAGHs had sustained efficacy and were generally well tolerated, with the exception of differences in the observed injection site pain for somatrogon. In general, they seemed to have comparable efficacy and safety to daily GH, in both the short and long term, and may have advantages to daily GH in terms of acceptability and adherence to GH replacement therapy.

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Medical Writing/Editorial Assistance

The authors would like to acknowledge Pepa Polavieja and Milana Ivkovic (Novo Nordisk) for critical revision of the manuscript and Caroline Spencer (Rx Communications, Mold, UK) for medical writing assistance with the preparation of this manuscript, funded by Novo Nordisk.

Author Contributions

Lasse de Fries Jensen: Conception, Design, interpretation of results and review. Vasileios Antavalis: Conception, Design, interpretation of results and review. Michael Højby: Interpretation of results and review. Alberto Pietropoli: Interpretation of results and review. Jan Odgaard-Jensen: Interpretation of results and review. Annachiara Rossi: Analysis, interpretation of results, and review.

This work and the journal’s Rapid Service and Open Access Fees were funded by Novo Nordisk.

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Lasse de Fries Jensen, Jan Odgaard-Jensen, Annachiara Rossi & Michael Højby

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Lasse de Fries Jensen, Vasileios Antavalis, Jan Odgaard-Jensen, Annachiara Rossi, Alberto Pietropoli and Michael Højby are full-time employees of Novo Nordisk.

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de Fries Jensen, L., Antavalis, V., Odgaard-Jensen, J. et al. Efficacy and Safety of Somapacitan Relative to Somatrogon and Lonapegsomatropin in Pediatric Growth Hormone Deficiency: Systematic Literature Review and Network Meta-analysis. Adv Ther (2024). https://doi.org/10.1007/s12325-024-02966-y

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Received : 12 June 2024

Accepted : 07 August 2024

Published : 11 September 2024

DOI : https://doi.org/10.1007/s12325-024-02966-y

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