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December 22, 2021

2021 Research Highlights — Promising Medical Findings

Results with potential for enhancing human health.

With NIH support, scientists across the United States and around the world conduct wide-ranging research to discover ways to enhance health, lengthen life, and reduce illness and disability. Groundbreaking NIH-funded research often receives top scientific honors. In 2021, these honors included Nobel Prizes to five NIH-supported scientists . Here’s just a small sample of the NIH-supported research accomplishments in 2021.

Printer-friendly version of full 2021 NIH Research Highlights

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Advancing COVID-19 treatment and prevention

Amid the sustained pandemic, researchers continued to develop new drugs and vaccines for COVID-19. They found oral drugs that could  inhibit virus replication in hamsters and shut down a key enzyme that the virus needs to replicate. Both drugs are currently in clinical trials. Another drug effectively treated both SARS-CoV-2 and RSV, another serious respiratory virus, in animals. Other researchers used an airway-on-a-chip to screen approved drugs for use against COVID-19. These studies identified oral drugs that could be administered outside of clinical settings. Such drugs could become powerful tools for fighting the ongoing pandemic. Also in development are an intranasal vaccine , which could help prevent virus transmission, and vaccines that can protect against a range of coronaviruses .

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Developments in Alzheimer’s disease research

One of the hallmarks of Alzheimer’s is an abnormal buildup of amyloid-beta protein. A study in mice suggests that antibody therapies targeting amyloid-beta protein could be more effective after enhancing the brain’s waste drainage system . In another study, irisin, an exercise-induced hormone, was found to improve cognitive performance in mice . New approaches also found two approved drugs (described below) with promise for treating AD. These findings point to potential strategies for treating Alzheimer’s. Meanwhile, researchers found that people who slept six hours or less per night in their 50s and 60s were more likely to develop dementia later in life, suggesting that inadequate sleep duration could increase dementia risk.

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New uses for old drugs

Developing new drugs can be costly, and the odds of success can be slim. So, some researchers have turned to repurposing drugs that are already approved for other conditions. Scientists found that two FDA-approved drugs were associated with lower rates of Alzheimer’s disease. One is used for high blood pressure and swelling. The other is FDA-approved to treat erectile dysfunction and pulmonary hypertension. Meanwhile, the antidepressant fluoxetine was associated with reduced risk of age-related macular degeneration. Clinical trials will be needed to confirm these drugs’ effects.

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Making a wireless, biodegradable pacemaker

Pacemakers are a vital part of medical care for many people with heart rhythm disorders. Temporary pacemakers currently use wires connected to a power source outside the body. Researchers developed a temporary pacemaker that is powered wirelessly. It also breaks down harmlessly in the body after use. Studies showed that the device can generate enough power to pace a human heart without causing damage or inflammation.

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Fungi may impair wound healing in Crohn’s disease

Inflammatory bowel disease develops when immune cells in the gut overreact to a perceived threat to the body. It’s thought that the microbiome plays a role in this process. Researchers found that a fungus called  Debaryomyces hansenii  impaired gut wound healing in mice and was also found in damaged gut tissue in people with Crohn’s disease, a type of inflammatory bowel disease. Blocking this microbe might encourage tissue repair in Crohn’s disease.

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Nanoparticle-based flu vaccine

Influenza, or flu, kills an estimated 290,000-650,000 people each year worldwide. The flu virus changes, or mutates, quickly. A single vaccine that conferred protection against a wide variety of strains would provide a major boost to global health. Researchers developed a nanoparticle-based vaccine that protected against a broad range of flu virus strains in animals. The vaccine may prevent flu more effectively than current seasonal vaccines. Researchers are planning a Phase 1 clinical trial to test the vaccine in people.

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A targeted antibiotic for treating Lyme disease

Lyme disease cases are becoming more frequent and widespread. Current treatment entails the use of broad-spectrum antibiotics. But these drugs can damage the patient’s gut microbiome and select for resistance in non-target bacteria. Researchers found that a neglected antibiotic called hygromycin A selectively kills the bacteria that cause Lyme disease. The antibiotic was able to treat Lyme disease in mice without disrupting the microbiome and could make an attractive therapeutic candidate.

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Retraining the brain to treat chronic pain

More than 25 million people in the U.S. live with chronic pain. After a treatment called pain reprocessing therapy, two-thirds of people with mild or moderate chronic back pain for which no physical cause could be found were mostly or completely pain-free. The findings suggest that people can learn to reduce the brain activity causing some types of chronic pain that occur in the absence of injury or persist after healing.

2021 Research Highlights — Basic Research Insights >>

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Open Access

Peer-reviewed

Research Article

Assessing the impact of healthcare research: A systematic review of methodological frameworks

Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Validation, Writing – original draft, Writing – review & editing

Affiliation Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom

Roles Conceptualization, Formal analysis, Funding acquisition, Methodology, Project administration, Supervision, Validation, Writing – review & editing

* E-mail: [email protected]

Roles Data curation, Formal analysis, Methodology, Validation, Writing – review & editing

Roles Formal analysis, Methodology, Supervision, Validation, Writing – review & editing

• Samantha Cruz Rivera, 
• Derek G. Kyte, 
• Olalekan Lee Aiyegbusi, 
• Thomas J. Keeley, 
• Melanie J. Calvert

• Published: August 9, 2017
• https://doi.org/10.1371/journal.pmed.1002370
• Reader Comments

Increasingly, researchers need to demonstrate the impact of their research to their sponsors, funders, and fellow academics. However, the most appropriate way of measuring the impact of healthcare research is subject to debate. We aimed to identify the existing methodological frameworks used to measure healthcare research impact and to summarise the common themes and metrics in an impact matrix.

Methods and findings

Two independent investigators systematically searched the Medical Literature Analysis and Retrieval System Online (MEDLINE), the Excerpta Medica Database (EMBASE), the Cumulative Index to Nursing and Allied Health Literature (CINAHL+), the Health Management Information Consortium, and the Journal of Research Evaluation from inception until May 2017 for publications that presented a methodological framework for research impact. We then summarised the common concepts and themes across methodological frameworks and identified the metrics used to evaluate differing forms of impact. Twenty-four unique methodological frameworks were identified, addressing 5 broad categories of impact: (1) ‘primary research-related impact’, (2) ‘influence on policy making’, (3) ‘health and health systems impact’, (4) ‘health-related and societal impact’, and (5) ‘broader economic impact’. These categories were subdivided into 16 common impact subgroups. Authors of the included publications proposed 80 different metrics aimed at measuring impact in these areas. The main limitation of the study was the potential exclusion of relevant articles, as a consequence of the poor indexing of the databases searched.

Conclusions

The measurement of research impact is an essential exercise to help direct the allocation of limited research resources, to maximise research benefit, and to help minimise research waste. This review provides a collective summary of existing methodological frameworks for research impact, which funders may use to inform the measurement of research impact and researchers may use to inform study design decisions aimed at maximising the short-, medium-, and long-term impact of their research.

Author summary

Why was this study done.

• There is a growing interest in demonstrating the impact of research in order to minimise research waste, allocate resources efficiently, and maximise the benefit of research. However, there is no consensus on which is the most appropriate tool to measure the impact of research.
• To our knowledge, this review is the first to synthesise existing methodological frameworks for healthcare research impact, and the associated impact metrics by which various authors have proposed impact should be measured, into a unified matrix.

What did the researchers do and find?

• We conducted a systematic review identifying 24 existing methodological research impact frameworks.
• We scrutinised the sample, identifying and summarising 5 proposed impact categories, 16 impact subcategories, and over 80 metrics into an impact matrix and methodological framework.

What do these findings mean?

• This simplified consolidated methodological framework will help researchers to understand how a research study may give rise to differing forms of impact, as well as in what ways and at which time points these potential impacts might be measured.
• Incorporating these insights into the design of a study could enhance impact, optimizing the use of research resources.

Citation: Cruz Rivera S, Kyte DG, Aiyegbusi OL, Keeley TJ, Calvert MJ (2017) Assessing the impact of healthcare research: A systematic review of methodological frameworks. PLoS Med 14(8): e1002370. https://doi.org/10.1371/journal.pmed.1002370

Academic Editor: Mike Clarke, Queens University Belfast, UNITED KINGDOM

Received: February 28, 2017; Accepted: July 7, 2017; Published: August 9, 2017

Copyright: © 2017 Cruz Rivera et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are within the paper and supporting files.

Funding: Funding was received from Consejo Nacional de Ciencia y Tecnología (CONACYT). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript ( http://www.conacyt.mx/ ).

Competing interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: MJC has received consultancy fees from Astellas and Ferring pharma and travel fees from the European Society of Cardiology outside the submitted work. TJK is in full-time paid employment for PAREXEL International.

Abbreviations: AIHS, Alberta Innovates—Health Solutions; CAHS, Canadian Academy of Health Sciences; CIHR, Canadian Institutes of Health Research; CINAHL+, Cumulative Index to Nursing and Allied Health Literature; EMBASE, Excerpta Medica Database; ERA, Excellence in Research for Australia; HEFCE, Higher Education Funding Council for England; HMIC, Health Management Information Consortium; HTA, Health Technology Assessment; IOM, Impact Oriented Monitoring; MDG, Millennium Development Goal; NHS, National Health Service; MEDLINE, Medical Literature Analysis and Retrieval System Online; PHC RIS, Primary Health Care Research & Information Service; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; PROM, patient-reported outcome measures; QALY, quality-adjusted life year; R&D, research and development; RAE, Research Assessment Exercise; REF, Research Excellence Framework; RIF, Research Impact Framework; RQF, Research Quality Framework; SDG, Sustainable Development Goal; SIAMPI, Social Impact Assessment Methods for research and funding instruments through the study of Productive Interactions between science and society

Introduction

In 2010, approximately US$240 billion was invested in healthcare research worldwide [ 1 ]. Such research is utilised by policy makers, healthcare providers, and clinicians to make important evidence-based decisions aimed at maximising patient benefit, whilst ensuring that limited healthcare resources are used as efficiently as possible to facilitate effective and sustainable service delivery. It is therefore essential that this research is of high quality and that it is impactful—i.e., it delivers demonstrable benefits to society and the wider economy whilst minimising research waste [ 1 , 2 ]. Research impact can be defined as ‘any identifiable ‘benefit to, or positive influence on the economy, society, public policy or services, health, the environment, quality of life or academia’ (p. 26) [ 3 ].

There are many purported benefits associated with the measurement of research impact, including the ability to (1) assess the quality of the research and its subsequent benefits to society; (2) inform and influence optimal policy and funding allocation; (3) demonstrate accountability, the value of research in terms of efficiency and effectiveness to the government, stakeholders, and society; and (4) maximise impact through better understanding the concept and pathways to impact [ 4 – 7 ].

Measuring and monitoring the impact of healthcare research has become increasingly common in the United Kingdom [ 5 ], Australia [ 5 ], and Canada [ 8 ], as governments, organisations, and higher education institutions seek a framework to allocate funds to projects that are more likely to bring the most benefit to society and the economy [ 5 ]. For example, in the UK, the 2014 Research Excellence Framework (REF) has recently been used to assess the quality and impact of research in higher education institutions, through the assessment of impact cases studies and selected qualitative impact metrics [ 9 ]. This is the first initiative to allocate research funding based on the economic, societal, and cultural impact of research, although it should be noted that research impact only drives a proportion of this allocation (approximately 20%) [ 9 ].

In the UK REF, the measurement of research impact is seen as increasingly important. However, the impact element of the REF has been criticised in some quarters [ 10 , 11 ]. Critics deride the fact that REF impact is determined in a relatively simplistic way, utilising researcher-generated case studies, which commonly attempt to link a particular research outcome to an associated policy or health improvement despite the fact that the wider literature highlights great diversity in the way research impact may be demonstrated [ 12 , 13 ]. This led to the current debate about the optimal method of measuring impact in the future REF [ 10 , 14 ]. The Stern review suggested that research impact should not only focus on socioeconomic impact but should also include impact on government policy, public engagement, academic impacts outside the field, and teaching to showcase interdisciplinary collaborative impact [ 10 , 11 ]. The Higher Education Funding Council for England (HEFCE) has recently set out the proposals for the REF 2021 exercise, confirming that the measurement of such impact will continue to form an important part of the process [ 15 ].

With increasing pressure for healthcare research to lead to demonstrable health, economic, and societal impact, there is a need for researchers to understand existing methodological impact frameworks and the means by which impact may be quantified (i.e., impact metrics; see Box 1 , 'Definitions’) to better inform research activities and funding decisions. From a researcher’s perspective, understanding the optimal pathways to impact can help inform study design aimed at maximising the impact of the project. At the same time, funders need to understand which aspects of impact they should focus on when allocating awards so they can make the most of their investment and bring the greatest benefit to patients and society [ 2 , 4 , 5 , 16 , 17 ].

Box 1. Definitions

• Research impact: ‘any identifiable benefit to, or positive influence on, the economy, society, public policy or services, health, the environment, quality of life, or academia’ (p. 26) [ 3 ].
• Methodological framework: ‘a body of methods, rules and postulates employed by a particular procedure or set of procedures (i.e., framework characteristics and development)’ [ 18 ].
• Pathway: ‘a way of achieving a specified result; a course of action’ [ 19 ].
• Quantitative metrics: ‘a system or standard of [quantitative] measurement’ [ 20 ].
• Narrative metrics: ‘a spoken or written account of connected events; a story’ [ 21 ].

Whilst previous researchers have summarised existing methodological frameworks and impact case studies [ 4 , 22 – 27 ], they have not summarised the metrics for use by researchers, funders, and policy makers. The aim of this review was therefore to (1) identify the methodological frameworks used to measure healthcare research impact using systematic methods, (2) summarise common impact themes and metrics in an impact matrix, and (3) provide a simplified consolidated resource for use by funders, researchers, and policy makers.

Search strategy and selection criteria

Initially, a search strategy was developed to identify the available literature regarding the different methods to measure research impact. The following keywords: ‘Impact’, ‘Framework’, and ‘Research’, and their synonyms, were used during the search of the Medical Literature Analysis and Retrieval System Online (MEDLINE; Ovid) database, the Excerpta Medica Database (EMBASE), the Health Management Information Consortium (HMIC) database, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL+) database (inception to May 2017; see S1 Appendix for the full search strategy). Additionally, the nonindexed Journal of Research Evaluation was hand searched during the same timeframe using the keyword ‘Impact’. Other relevant articles were identified through 3 Internet search engines (Google, Google Scholar, and Google Images) using the keywords ‘Impact’, ‘Framework’, and ‘Research’, with the first 50 results screened. Google Images was searched because different methodological frameworks are summarised in a single image and can easily be identified through this search engine. Finally, additional publications were sought through communication with experts.

Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (see S1 PRISMA Checklist ), 2 independent investigators systematically screened for publications describing, evaluating, or utilising a methodological research impact framework within the context of healthcare research [ 28 ]. Papers were eligible if they included full or partial methodological frameworks or pathways to research impact; both primary research and systematic reviews fitting these criteria were included. We included any methodological framework identified (original or modified versions) at the point of first occurrence. In addition, methodological frameworks were included if they were applicable to the healthcare discipline with no need of modification within their structure. We defined ‘methodological framework’ as ‘a body of methods, rules and postulates employed by a particular procedure or set of procedures (i.e., framework characteristics and development)’ [ 18 ], whereas we defined ‘pathway’ as ‘a way of achieving a specified result; a course of action’ [ 19 ]. Studies were excluded if they presented an existing (unmodified) methodological framework previously available elsewhere, did not explicitly describe a methodological framework but rather focused on a single metric (e.g., bibliometric analysis), focused on the impact or effectiveness of interventions rather than that of the research, or presented case study data only. There were no language restrictions.

Data screening

Records were downloaded into Endnote (version X7.3.1), and duplicates were removed. Two independent investigators (SCR and OLA) conducted all screening following a pilot aimed at refining the process. The records were screened by title and abstract before full-text articles of potentially eligible publications were retrieved for evaluation. A full-text screening identified the publications included for data extraction. Discrepancies were resolved through discussion, with the involvement of a third reviewer (MJC, DGK, and TJK) when necessary.

Data extraction and analysis

Data extraction occurred after the final selection of included articles. SCR and OLA independently extracted details of impact methodological frameworks, the country of origin, and the year of publication, as well as the source, the framework description, and the methodology used to develop the framework. Information regarding the methodology used to develop each methodological framework was also extracted from framework webpages where available. Investigators also extracted details regarding each framework’s impact categories and subgroups, along with their proposed time to impact (‘short-term’, ‘mid-term’, or ‘long-term’) and the details of any metrics that had been proposed to measure impact, which are depicted in an impact matrix. The structure of the matrix was informed by the work of M. Buxton and S. Hanney [ 2 ], P. Buykx et al. [ 5 ], S. Kuruvila et al. [ 29 ], and A. Weiss [ 30 ], with the intention of mapping metrics presented in previous methodological frameworks in a concise way. A consensus meeting with MJC, DGK, and TJK was held to solve disagreements and finalise the data extraction process.

Included studies

Our original search strategy identified 359 citations from MEDLINE (Ovid), EMBASE, CINAHL+, HMIC, and the Journal of Research Evaluation, and 101 citations were returned using other sources (Google, Google Images, Google Scholar, and expert communication) (see Fig 1 ) [ 28 ]. In total, we retrieved 54 full-text articles for review. At this stage, 39 articles were excluded, as they did not propose new or modified methodological frameworks. An additional 15 articles were included following the backward and forward citation method. A total of 31 relevant articles were included in the final analysis, of which 24 were articles presenting unique frameworks and the remaining 7 were systematic reviews [ 4 , 22 – 27 ]. The search strategy was rerun on 15 May 2017. A further 19 publications were screened, and 2 were taken forward to full-text screening but were ineligible for inclusion.

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https://doi.org/10.1371/journal.pmed.1002370.g001

Methodological framework characteristics

The characteristics of the 24 included methodological frameworks are summarised in Table 1 , 'Methodological framework characteristics’. Fourteen publications proposed academic-orientated frameworks, which focused on measuring academic, societal, economic, and cultural impact using narrative and quantitative metrics [ 2 , 3 , 5 , 8 , 29 , 31 – 39 ]. Five publications focused on assessing the impact of research by focusing on the interaction process between stakeholders and researchers (‘productive interactions’), which is a requirement to achieve research impact. This approach tries to address the issue of attributing research impact to metrics [ 7 , 40 – 43 ]. Two frameworks focused on the importance of partnerships between researchers and policy makers, as a core element to accomplish research impact [ 44 , 45 ]. An additional 2 frameworks focused on evaluating the pathways to impact, i.e., linking processes between research and impact [ 30 , 46 ]. One framework assessed the ability of health technology to influence efficiency of healthcare systems [ 47 ]. Eight frameworks were developed in the UK [ 2 , 3 , 29 , 37 , 39 , 42 , 43 , 45 ], 6 in Canada [ 8 , 33 , 34 , 44 , 46 , 47 ], 4 in Australia [ 5 , 31 , 35 , 38 ], 3 in the Netherlands [ 7 , 40 , 41 ], and 2 in the United States [ 30 , 36 ], with 1 model developed with input from various countries [ 32 ].

https://doi.org/10.1371/journal.pmed.1002370.t001

Methodological framework development

The included methodological frameworks varied in their development process, but there were some common approaches employed. Most included a literature review [ 2 , 5 , 7 , 8 , 31 , 33 , 36 , 37 , 40 – 46 ], although none of them used a recognised systematic method. Most also consulted with various stakeholders [ 3 , 8 , 29 , 31 , 33 , 35 – 38 , 43 , 44 , 46 , 47 ] but used differing methods to incorporate their views, including quantitative surveys [ 32 , 35 , 43 , 46 ], face-to-face interviews [ 7 , 29 , 33 , 35 , 37 , 42 , 43 ], telephone interviews [ 31 , 46 ], consultation [ 3 , 7 , 36 ], and focus groups [ 39 , 43 ]. A range of stakeholder groups were approached across the sample, including principal investigators [ 7 , 29 , 43 ], research end users [ 7 , 42 , 43 ], academics [ 3 , 8 , 39 , 40 , 43 , 46 ], award holders [ 43 ], experts [ 33 , 38 , 39 ], sponsors [ 33 , 39 ], project coordinators [ 32 , 42 ], and chief investigators [ 31 , 35 ]. However, some authors failed to identify the stakeholders involved in the development of their frameworks [ 2 , 5 , 34 , 41 , 45 ], making it difficult to assess their appropriateness. In addition, only 4 of the included papers reported using formal analytic methods to interpret stakeholder responses. These included the Canadian Academy of Health Sciences framework, which used conceptual cluster analysis [ 33 ]. The Research Contribution [ 42 ], Research Impact [ 29 ], and Primary Health Care & Information Service [ 31 ] used a thematic analysis approach. Finally, some authors went on to pilot their framework, which shaped refinements on the methodological frameworks until approval. Methods used to pilot the frameworks included a case study approach [ 2 , 3 , 30 , 32 , 33 , 36 , 40 , 42 , 44 , 45 ], contrasting results against available literature [ 29 ], the use of stakeholders’ feedback [ 7 ], and assessment tools [ 35 , 46 ].

Major impact categories

1. primary research-related impact..

A number of methodological frameworks advocated the evaluation of ‘research-related impact’. This encompassed content related to the generation of new knowledge, knowledge dissemination, capacity building, training, leadership, and the development of research networks. These outcomes were considered the direct or primary impacts of a research project, as these are often the first evidenced returns [ 30 , 62 ].

A number of subgroups were identified within this category, with frameworks supporting the collection of impact data across the following constructs: ‘research and innovation outcomes’; ‘dissemination and knowledge transfer’; ‘capacity building, training, and leadership’; and ‘academic collaborations, research networks, and data sharing’.

1 . 1 . Research and innovation outcomes . Twenty of the 24 frameworks advocated the evaluation of ‘research and innovation outcomes’ [ 2 , 3 , 5 , 7 , 8 , 29 – 39 , 41 , 43 , 44 , 46 ]. This subgroup included the following metrics: number of publications; number of peer-reviewed articles (including journal impact factor); citation rates; requests for reprints, number of reviews, and meta-analysis; and new or changes in existing products (interventions or technology), patents, and research. Additionally, some frameworks also sought to gather information regarding ‘methods/methodological contributions’. These advocated the collection of systematic reviews and appraisals in order to identify gaps in knowledge and determine whether the knowledge generated had been assessed before being put into practice [ 29 ].

1 . 2 . Dissemination and knowledge transfer . Nineteen of the 24 frameworks advocated the assessment of ‘dissemination and knowledge transfer’ [ 2 , 3 , 5 , 7 , 29 – 32 , 34 – 43 , 46 ]. This comprised collection of the following information: number of conferences, seminars, workshops, and presentations; teaching output (i.e., number of lectures given to disseminate the research findings); number of reads for published articles; article download rate and number of journal webpage visits; and citations rates in nonjournal media such as newspapers and mass and social media (i.e., Twitter and blogs). Furthermore, this impact subgroup considered the measurement of research uptake and translatability and the adoption of research findings in technological and clinical applications and by different fields. These can be measured through patents, clinical trials, and partnerships between industry and business, government and nongovernmental organisations, and university research units and researchers [ 29 ].

1 . 3 . Capacity building , training , and leadership . Fourteen of 24 frameworks suggested the evaluation of ‘capacity building, training, and leadership’ [ 2 , 3 , 5 , 8 , 29 , 31 – 35 , 39 – 41 , 43 ]. This involved collecting information regarding the number of doctoral and postdoctoral studentships (including those generated as a result of the research findings and those appointed to conduct the research), as well as the number of researchers and research-related staff involved in the research projects. In addition, authors advocated the collection of ‘leadership’ metrics, including the number of research projects managed and coordinated and the membership of boards and funding bodies, journal editorial boards, and advisory committees [ 29 ]. Additional metrics in this category included public recognition (number of fellowships and awards for significant research achievements), academic career advancement, and subsequent grants received. Lastly, the impact metric ‘research system management’ comprised the collection of information that can lead to preserving the health of the population, such as modifying research priorities, resource allocation strategies, and linking health research to other disciplines to maximise benefits [ 29 ].

1 . 4 . Academic collaborations , research networks , and data sharing . Lastly, 10 of the 24 frameworks advocated the collection of impact data regarding ‘academic collaborations (internal and external collaborations to complete a research project), research networks, and data sharing’ [ 2 , 3 , 5 , 7 , 29 , 34 , 37 , 39 , 41 , 43 ].

2. Influence on policy making.

Methodological frameworks addressing this major impact category focused on measurable improvements within a given knowledge base and on interactions between academics and policy makers, which may influence policy-making development and implementation. The returns generated in this impact category are generally considered as intermediate or midterm (1 to 3 years). These represent an important interim stage in the process towards the final expected impacts, such as quantifiable health improvements and economic benefits, without which policy change may not occur [ 30 , 62 ]. The following impact subgroups were identified within this category: ‘type and nature of policy impact’, ‘level of policy making’, and ‘policy networks’.

2 . 1 . Type and nature of policy impact . The most common impact subgroup, mentioned in 18 of the 24 frameworks, was ‘type and nature of policy impact’ [ 2 , 7 , 29 – 38 , 41 – 43 , 45 – 47 ]. Methodological frameworks addressing this subgroup stressed the importance of collecting information regarding the influence of research on policy (i.e., changes in practice or terminology). For instance, a project looking at trafficked adolescents and women (2003) influenced the WHO guidelines (2003) on ethics regarding this particular group [ 17 , 21 , 63 ].

2 . 2 . Level of policy impact . Thirteen of 24 frameworks addressed aspects surrounding the need to record the ‘level of policy impact’ (international, national, or local) and the organisations within a level that were influenced (local policy makers, clinical commissioning groups, and health and wellbeing trusts) [ 2 , 5 , 8 , 29 , 31 , 34 , 38 , 41 , 43 – 47 ]. Authors considered it important to measure the ‘level of policy impact’ to provide evidence of collaboration, coordination, and efficiency within health organisations and between researchers and health organisations [ 29 , 31 ].

2 . 3 . Policy networks . Five methodological frameworks highlighted the need to collect information regarding collaborative research with industry and staff movement between academia and industry [ 5 , 7 , 29 , 41 , 43 ]. A policy network emphasises the relationship between policy communities, researchers, and policy makers. This relationship can influence and lead to incremental changes in policy processes [ 62 ].

3. Health and health systems impact.

A number of methodological frameworks advocated the measurement of impacts on health and healthcare systems across the following impact subgroups: ‘quality of care and service delivering’, ‘evidence-based practice’, ‘improved information and health information management’, ‘cost containment and effectiveness’, ‘resource allocation’, and ‘health workforce’.

3 . 1 . Quality of care and service delivery . Twelve of the 24 frameworks highlighted the importance of evaluating ‘quality of care and service delivery’ [ 2 , 5 , 8 , 29 – 31 , 33 – 36 , 41 , 47 ]. There were a number of suggested metrics that could be potentially used for this purpose, including health outcomes such as quality-adjusted life years (QALYs), patient-reported outcome measures (PROMs), patient satisfaction and experience surveys, and qualitative data on waiting times and service accessibility.

3 . 2 . Evidence-based practice . ‘Evidence-based practice’, mentioned in 5 of the 24 frameworks, refers to making changes in clinical diagnosis, clinical practice, treatment decisions, or decision making based on research evidence [ 5 , 8 , 29 , 31 , 33 ]. The suggested metrics to demonstrate evidence-based practice were adoption of health technologies and research outcomes to improve the healthcare systems and inform policies and guidelines [ 29 ].

3 . 3 . Improved information and health information management . This impact subcategory, mentioned in 5 of the 24 frameworks, refers to the influence of research on the provision of health services and management of the health system to prevent additional costs [ 5 , 29 , 33 , 34 , 38 ]. Methodological frameworks advocated the collection of health system financial, nonfinancial (i.e., transport and sociopolitical implications), and insurance information in order to determine constraints within a health system.

3 . 4 . Cost containment and cost-effectiveness . Six of the 24 frameworks advocated the subcategory ‘cost containment and cost-effectiveness’ [ 2 , 5 , 8 , 17 , 33 , 36 ]. ‘Cost containment’ comprised the collection of information regarding how research has influenced the provision and management of health services and its implication in healthcare resource allocation and use [ 29 ]. ‘Cost-effectiveness’ refers to information concerning economic evaluations to assess improvements in effectiveness and health outcomes—for instance, the cost-effectiveness (cost and health outcome benefits) assessment of introducing a new health technology to replace an older one [ 29 , 31 , 64 ].

3 . 5 . Resource allocation . ‘Resource allocation’, mentioned in 6frameworks, can be measured through 2 impact metrics: new funding attributed to the intervention in question and equity while allocating resources, such as improved allocation of resources at an area level; better targeting, accessibility, and utilisation; and coverage of health services [ 2 , 5 , 29 , 31 , 45 , 47 ]. The allocation of resources and targeting can be measured through health services research reports, with the utilisation of health services measured by the probability of providing an intervention when needed, the probability of requiring it again in the future, and the probability of receiving an intervention based on previous experience [ 29 , 31 ].

3 . 6 . Health workforce . Lastly, ‘health workforce’, present in 3 methodological frameworks, refers to the reduction in the days of work lost because of a particular illness [ 2 , 5 , 31 ].

4. Health-related and societal impact.

Three subgroups were included in this category: ‘health literacy’; ‘health knowledge, attitudes, and behaviours’; and ‘improved social equity, inclusion, or cohesion’.

4 . 1 . Health knowledge , attitudes , and behaviours . Eight of the 24 frameworks suggested the assessment of ‘health knowledge, attitudes, behaviours, and outcomes’, which could be measured through the evaluation of levels of public engagement with science and research (e.g., National Health Service (NHS) Choices end-user visit rate) or by using focus groups to analyse changes in knowledge, attitudes, and behaviour among society [ 2 , 5 , 29 , 33 – 35 , 38 , 43 ].

4 . 2 . Improved equity , inclusion , or cohesion and human rights . Other methodological frameworks, 4 of the 24, suggested capturing improvements in equity, inclusion, or cohesion and human rights. Authors suggested these could be using a resource like the United Nations Millennium Development Goals (MDGs) (superseded by Sustainable Development Goals [SDGs] in 2015) and human rights [ 29 , 33 , 34 , 38 ]. For instance, a cluster-randomised controlled trial in Nepal, which had female participants, has demonstrated the reduction of neonatal mortality through the introduction of maternity health care, distribution of delivery kits, and home visits. This illustrates how research can target vulnerable and disadvantaged groups. Additionally, this research has been introduced by the World Health Organisation to achieve the MDG ‘improve maternal health’ [ 16 , 29 , 65 ].

4 . 3 . Health literacy . Some methodological frameworks, 3 of the 24, focused on tracking changes in the ability of patients to make informed healthcare decisions, reduce health risks, and improve quality of life, which were demonstrably linked to a particular programme of research [ 5 , 29 , 43 ]. For example, a systematic review showed that when HIV health literacy/knowledge is spread among people living with the condition, antiretroviral adherence and quality of life improve [ 66 ].

5. Broader economic impacts.

Some methodological frameworks, 9 of 24, included aspects related to the broader economic impacts of health research—for example, the economic benefits emerging from the commercialisation of research outputs [ 2 , 5 , 29 , 31 , 33 , 35 , 36 , 38 , 67 ]. Suggested metrics included the amount of funding for research and development (R&D) that was competitively awarded by the NHS, medical charities, and overseas companies. Additional metrics were income from intellectual property, spillover effects (any secondary benefit gained as a repercussion of investing directly in a primary activity, i.e., the social and economic returns of investing on R&D) [ 33 ], patents granted, licences awarded and brought to the market, the development and sales of spinout companies, research contracts, and income from industry.

The benefits contained within the categories ‘health and health systems impact’, ‘health-related and societal impact’, and ‘broader economic impacts’ are considered the expected and final returns of the resources allocated in healthcare research [ 30 , 62 ]. These benefits commonly arise in the long term, beyond 5 years according to some authors, but there was a recognition that this could differ depending on the project and its associated research area [ 4 ].

Data synthesis

Five major impact categories were identified across the 24 included methodological frameworks: (1) ‘primary research-related impact’, (2) ‘influence on policy making’, (3) ‘health and health systems impact’, (4) ‘health-related and societal impact’, and (5) ‘broader economic impact’. These major impact categories were further subdivided into 16 impact subgroups. The included publications proposed 80 different metrics to measure research impact. This impact typology synthesis is depicted in ‘the impact matrix’ ( Fig 2 and Fig 3 ).

CIHR, Canadian Institutes of Health Research; HTA, Health Technology Assessment; PHC RIS, Primary Health Care Research & Information Service; RAE, Research Assessment Exercise; RQF, Research Quality Framework.

https://doi.org/10.1371/journal.pmed.1002370.g002

AIHS, Alberta Innovates—Health Solutions; CAHS, Canadian Institutes of Health Research; IOM, Impact Oriented Monitoring; REF, Research Excellence Framework; SIAMPI, Social Impact Assessment Methods for research and funding instruments through the study of Productive Interactions between science and society.

https://doi.org/10.1371/journal.pmed.1002370.g003

Commonality and differences across frameworks

The ‘Research Impact Framework’ and the ‘Health Services Research Impact Framework’ were the models that encompassed the largest number of the metrics extracted. The most dominant methodological framework was the Payback Framework; 7 other methodological framework models used the Payback Framework as a starting point for development [ 8 , 29 , 31 – 35 ]. Additional methodological frameworks that were commonly incorporated into other tools included the CIHR framework, the CAHS model, the AIHS framework, and the Exchange model [ 8 , 33 , 34 , 44 ]. The capture of ‘research-related impact’ was the most widely advocated concept across methodological frameworks, illustrating the importance with which primary short-term impact outcomes were viewed by the included papers. Thus, measurement of impact via number of publications, citations, and peer-reviewed articles was the most common. ‘Influence on policy making’ was the predominant midterm impact category, specifically the subgroup ‘type and nature of policy impact’, in which frameworks advocated the measurement of (i) changes to legislation, regulations, and government policy; (ii) influence and involvement in decision-making processes; and (iii) changes to clinical or healthcare training, practice, or guidelines. Within more long-term impact measurement, the evaluations of changes in the ‘quality of care and service delivery’ were commonly advocated.

In light of the commonalities and differences among the methodological frameworks, the ‘pathways to research impact’ diagram ( Fig 4 ) was developed to provide researchers, funders, and policy makers a more comprehensive and exhaustive way to measure healthcare research impact. The diagram has the advantage of assorting all the impact metrics proposed by previous frameworks and grouping them into different impact subgroups and categories. Prospectively, this global picture will help researchers, funders, and policy makers plan strategies to achieve multiple pathways to impact before carrying the research out. The analysis of the data extraction and construction of the impact matrix led to the development of the ‘pathways to research impact’ diagram ( Fig 4 ). The diagram aims to provide an exhaustive and comprehensive way of tracing research impact by combining all the impact metrics presented by the different 24 frameworks, grouping those metrics into different impact subgroups, and grouping these into broader impact categories.

NHS, National Health Service; PROM, patient-reported outcome measure; QALY, quality-adjusted life year; R&D, research and development.

https://doi.org/10.1371/journal.pmed.1002370.g004

This review has summarised existing methodological impact frameworks together for the first time using systematic methods ( Fig 4 ). It allows researchers and funders to consider pathways to impact at the design stage of a study and to understand the elements and metrics that need to be considered to facilitate prospective assessment of impact. Users do not necessarily need to cover all the aspects of the methodological framework, as every research project can impact on different categories and subgroups. This review provides information that can assist researchers to better demonstrate impact, potentially increasing the likelihood of conducting impactful research and reducing research waste. Existing reviews have not presented a methodological framework that includes different pathways to impact, health impact categories, subgroups, and metrics in a single methodological framework.

Academic-orientated frameworks included in this review advocated the measurement of impact predominantly using so-called ‘quantitative’ metrics—for example, the number of peer-reviewed articles, journal impact factor, and citation rates. This may be because they are well-established measures, relatively easy to capture and objective, and are supported by research funding systems. However, these metrics primarily measure the dissemination of research finding rather than its impact [ 30 , 68 ]. Whilst it is true that wider dissemination, especially when delivered via world-leading international journals, may well lead eventually to changes in healthcare, this is by no means certain. For instance, case studies evaluated by Flinders University of Australia demonstrated that some research projects with non-peer-reviewed publications led to significant changes in health policy, whilst the studies with peer-reviewed publications did not result in any type of impact [ 68 ]. As a result, contemporary literature has tended to advocate the collection of information regarding a variety of different potential forms of impact alongside publication/citations metrics [ 2 , 3 , 5 , 7 , 8 , 29 – 47 ], as outlined in this review.

The 2014 REF exercise adjusted UK university research funding allocation based on evidence of the wider impact of research (through case narrative studies and quantitative metrics), rather than simply according to the quality of research [ 12 ]. The intention was to ensure funds were directed to high-quality research that could demonstrate actual realised benefit. The inclusion of a mixed-method approach to the measurement of impact in the REF (narrative and quantitative metrics) reflects a widespread belief—expressed by the majority of authors of the included methodological frameworks in the review—that individual quantitative impact metrics (e.g., number of citations and publications) do not necessary capture the complexity of the relationships involved in a research project and may exclude measurement of specific aspects of the research pathway [ 10 , 12 ].

Many of the frameworks included in this review advocated the collection of a range of academic, societal, economic, and cultural impact metrics; this is consistent with recent recommendations from the Stern review [ 10 ]. However, a number of these metrics encounter research ‘lag’: i.e., the time between the point at which the research is conducted and when the actual benefits arise [ 69 ]. For instance, some cardiovascular research has taken up to 25 years to generate impact [ 70 ]. Likewise, the impact may not arise exclusively from a single piece of research. Different processes (such as networking interactions and knowledge and research translation) and multiple individuals and organisations are often involved [ 4 , 71 ]. Therefore, attributing the contribution made by each of the different actors involved in the process can be a challenge [ 4 ]. An additional problem associated to attribution is the lack of evidence to link research and impact. The outcomes of research may emerge slowly and be absorbed gradually. Consequently, it is difficult to determine the influence of research in the development of a new policy, practice, or guidelines [ 4 , 23 ].

A further problem is that impact evaluation is conducted ‘ex post’, after the research has concluded. Collecting information retrospectively can be an issue, as the data required might not be available. ‘ex ante’ assessment is vital for funding allocation, as it is necessary to determine the potential forthcoming impact before research is carried out [ 69 ]. Additionally, ex ante evaluation of potential benefit can overcome the issues regarding identifying and capturing evidence, which can be used in the future [ 4 ]. In order to conduct ex ante evaluation of potential benefit, some authors suggest the early involvement of policy makers in a research project coupled with a well-designed strategy of dissemination [ 40 , 69 ].

Providing an alternate view, the authors of methodological frameworks such as the SIAMPI, Contribution Mapping, Research Contribution, and the Exchange model suggest that the problems of attribution are a consequence of assigning the impact of research to a particular impact metric [ 7 , 40 , 42 , 44 ]. To address these issues, these authors propose focusing on the contribution of research through assessing the processes and interactions between stakeholders and researchers, which arguably take into consideration all the processes and actors involved in a research project [ 7 , 40 , 42 , 43 ]. Additionally, contributions highlight the importance of the interactions between stakeholders and researchers from an early stage in the research process, leading to a successful ex ante and ex post evaluation by setting expected impacts and determining how the research outcomes have been utilised, respectively [ 7 , 40 , 42 , 43 ]. However, contribution metrics are generally harder to measure in comparison to academic-orientated indicators [ 72 ].

Currently, there is a debate surrounding the optimal methodological impact framework, and no tool has proven superior to another. The most appropriate methodological framework for a given study will likely depend on stakeholder needs, as each employs different methodologies to assess research impact [ 4 , 37 , 41 ]. This review allows researchers to select individual existing methodological framework components to create a bespoke tool with which to facilitate optimal study design and maximise the potential for impact depending on the characteristic of their study ( Fig 2 and Fig 3 ). For instance, if researchers are interested in assessing how influential their research is on policy making, perhaps considering a suite of the appropriate metrics drawn from multiple methodological frameworks may provide a more comprehensive method than adopting a single methodological framework. In addition, research teams may wish to use a multidimensional approach to methodological framework development, adopting existing narratives and quantitative metrics, as well as elements from contribution frameworks. This approach would arguably present a more comprehensive method of impact assessment; however, further research is warranted to determine its effectiveness [ 4 , 69 , 72 , 73 ].

Finally, it became clear during this review that the included methodological frameworks had been constructed using varied methodological processes. At present, there are no guidelines or consensus around the optimal pathway that should be followed to develop a robust methodological framework. The authors believe this is an area that should be addressed by the research community, to ensure future frameworks are developed using best-practice methodology.

For instance, the Payback Framework drew upon a literature review and was refined through a case study approach. Arguably, this approach could be considered inferior to other methods that involved extensive stakeholder involvement, such as the CIHR framework [ 8 ]. Nonetheless, 7 methodological frameworks were developed based upon the Payback Framework [ 8 , 29 , 31 – 35 ].

Limitations

The present review is the first to summarise systematically existing impact methodological frameworks and metrics. The main limitation is that 50% of the included publications were found through methods other than bibliographic databases searching, indicating poor indexing. Therefore, some relevant articles may not have been included in this review if they failed to indicate the inclusion of a methodological impact framework in their title/abstract. We did, however, make every effort to try to find these potentially hard-to-reach publications, e.g., through forwards/backwards citation searching, hand searching reference lists, and expert communication. Additionally, this review only extracted information regarding the methodology followed to develop each framework from the main publication source or framework webpage. Therefore, further evaluations may not have been included, as they are beyond the scope of the current paper. A further limitation was that although our search strategy did not include language restrictions, we did not specifically search non-English language databases. Thus, we may have failed to identify potentially relevant methodological frameworks that were developed in a non-English language setting.

In conclusion, the measurement of research impact is an essential exercise to help direct the allocation of limited research resources, to maximise benefit, and to help minimise research waste. This review provides a collective summary of existing methodological impact frameworks and metrics, which funders may use to inform the measurement of research impact and researchers may use to inform study design decisions aimed at maximising the short-, medium-, and long-term impact of their research.

Supporting information

S1 appendix. search strategy..

https://doi.org/10.1371/journal.pmed.1002370.s001

S1 PRISMA Checklist. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist.

https://doi.org/10.1371/journal.pmed.1002370.s002

Acknowledgments

We would also like to thank Mrs Susan Bayliss, Information Specialist, University of Birmingham, and Mrs Karen Biddle, Research Secretary, University of Birmingham.

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What has the pandemic revealed about the US health care system — and what needs to change?

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With vaccinations for Covid-19 now underway across the nation, MIT SHASS Communications asked seven MIT scholars engaged in health and health care research to share their views on what the pandemic has revealed about the U.S. health care system — and what needs to change. Representing the fields of medicine, anthropology, political science, health economics, science writing, and medical humanities, these researchers articulate a range of opportunities for U.S. health care to become more equitable, more effective and coherent, and more prepared for the next pandemic.

Dwaipayan Banerjee , associate professor of science, technology, and society

On the heels of Ebola, Covid-19 put to rest a persistent, false binary between diseases of the rich and diseases of the poor. For several decades, health care policymakers have labored under the impression of a great epidemiological transition. This theory holds that the developed world has reached a stage in its history that it no longer needs to worry about communicable diseases. These "diseases of the poor" are only supposed to exist in distant places with weak governments and struggling economies. Not here in the United States.

On the surface, Covid-19 made clear that diseases do not respect national boundaries. More subtly, it tested the hypothesis that the global north no longer need concern itself with communicable disease. And in so doing, it undermined our assumptions about global north health-care infrastructures as paradigmatically more evolved. Over the last decades, the United States has been focused on developing increasingly sophisticated drugs. While this effort has ushered in several technological breakthroughs, a preoccupation with magic-bullet cures has distracted from public health fundamentals. The spread of the virus revealed shortages in basic equipment and hospitals beds, the disproportionate effects of disease on the marginalized, the challenge of prevention rather than cure, the limits of insurance-based models to provide equitable care, and our unacknowledged dependence on the labor of underpaid health care workers.

To put it plainly, the pandemic did not create a crisis in U.S. health care. For many in the United States, crisis was already a precondition of care, delivered in emergency rooms and negotiated through denied insurance claims. As we begin to imagine a "new normal," we must ask questions about the old. The pandemic made clear that the "normal" had been a privilege only for a few well-insured citizens. In its wake, can we imagine a health-care system that properly compensates labor and recognizes health care as a right, rather than a privilege only available to the marginalized when an endemic crisis is magnified by a pandemic emergency? 

Andrea Campbell , professor of political science

No doubt, the pandemic reveals the dire need to invest in public-health infrastructure to better monitor and address public-health threats in the future, and to expand insurance coverage and health care access. To my mind, however, the pandemic’s greatest significance is in revealing the racism woven into American social and economic policy.

Public policies helped create geographic and occupational segregation to begin with; inadequate racist and classist public policies do a poor job of mitigating their effects. Structural racism manifests at the individual level, with people of color suffering worse housing and exposure to toxins, less access to education and jobs, greater financial instability, poorer physical and mental health, and higher infant mortality and shorter lifespans than their white counterparts. Residential segregation means many white Americans do not see these harms.

Structural racism also materializes at the societal level, a colossal waste of human capital that undercuts the nation’s economic growth, as social and economic policy expert Heather McGhee shows in her illuminating book, "The Sum of Us." These society-wide costs are hidden as well; it is difficult to comprehend the counterfactual of what growth would look like if all Americans could prosper. My hope is that the pandemic renders this structural inequality visible. There is little point in improving medical or public-health systems if we fail to address the structural drivers of poor health. We must seize the opportunity to improve housing, nutrition, and schools; to enforce regulations on workplace safety, redlining, and environmental hazards; and to implement paid sick leave and paid family leave, among other changes. It has been too easy for healthy, financially stable, often white Americans to think the vulnerable are residual. The pandemic has revealed that they are in fact central. It’s time to invest for a more equitable future.

Jonathan Gruber , Ford Professor of Economics

The Covid-19 pandemic is the single most important health event of the past 100 years, and as such has enormous implications for our health care system. Most significantly, it highlights the importance of universal, non-discriminatory health insurance coverage in the United States. The primary source of health insurance for Americans is their job, and with unemployment reaching its highest level since the Great Depression, tens of millions of workers lost, at least temporarily, their insurance coverage.

Moreover, even once the economy recovers, millions of Americans will have a new preexisting condition, Covid-19. That’s why it is critical to build on the initial successes of the Affordable Care Act to continue to move toward a safety net that provides insurance options for all without discrimination.

The pandemic has also illustrated the power of remote health care. The vast majority of patients in the United States have had their first experience with telehealth during the pandemic and found it surprisingly satisfactory. More use of telehealth can lead to increased efficiency of health care delivery as well as allowing our system to reach underserved areas more effectively.

The pandemic also showed us the value of government sponsorship of innovation in the health sciences. The speed with which the vaccines were developed is breathtaking. But it would not have been possible without decades of National Institute of Health investments such as the Human Genome Project, nor without the large incentives put in place by Operation Warp Speed. Even in peacetime, the government has a critical role to play in promoting health care innovation

The single most important change that we need to make to be prepared for the next pandemic is to recognize that proper preparation is, by definition, overpreparation. Unless we are prepared for the next pandemic that doesn’t happen, we won’t possibly be ready for the next pandemic that does.

This means working now, while the memory is fresh, to set up permanent, mandatorily funded institutions to do global disease surveillance, extensive testing of any at-risk populations when new diseases are detected, and a permanent government effort to finance underdeveloped vaccines and therapeutics.

Jeffrey Harris , professor emeritus of economics and a practicing physician The pandemic has revealed the American health care system to be a non-system. In a genuine system, health care providers would coordinate their services. Yet when Elmhurst Hospital in Queens was overrun with patients, some 3,500 beds remained available in other New York hospitals. In a genuine system, everyone would have a stable source of care at a health maintenance organization (HMO). While our country has struggled to distribute the Covid-19 vaccine efficiently and equitably, Israel, which has just such an HMO-based system, has broken world records for vaccination.

Germany, which has all along had a robust public health care system, was accepting sick patients from Italy, Spain, and France. Meanwhile, U.S. hospitals were in financial shock and fee-for-service-based physician practices were devastated. We need to move toward a genuine health care system that can withstand shocks like the Covid-19 pandemic. There are already models out there to imitate. We need to strengthen our worldwide pandemic and global health crisis alert systems. Despite concerns about China’s early attempts to suppress the bad news about Covid-19, the world was lucky that Chinese investigators posted the full genome of SARS-CoV-2 in January 2020 — the singular event that triggered the search for a vaccine. With the recurrent threat of yet another pandemic — after H1N1, SARS, MERS, Ebola, and now SARS-Cov-2 — along with the anticipated health consequences of global climate change, we can’t simply cross our fingers and hope to get lucky again.

Erica Caple James , associate professor of medical anthropology and urban studies The coronavirus pandemic has revealed some of the limits of the American medical and health care system and demonstrated many of the social determinants of health. Neither the risks of infection nor the probability of suffering severe illness are equal across populations. Each depends on socioeconomic factors such as type of employment, mode of transportation, housing status, environmental vulnerability, and capacity to prevent spatial exposure, as well as “preexisting” health conditions like diabetes, obesity, and chronic respiratory illness.

Such conditions are often determined by race, ethnicity, gender, and “biology,” but also poverty, cultural and linguistic facility, health literacy, and legal status. In terms of mapping the prevalence of infection, it can be difficult to trace contacts among persons who are regular users of medical infrastructure. However, it can be extraordinarily difficult to do so among persons who lack or fear such visibility, especially when a lack of trust can color patient-clinician relationships.

One’s treatment within medical and health care systems may also reflect other health disparities — such as when clinicians discount patient symptom reports because of sociocultural, racial, or gender stereotypes, or when technologies are calibrated to the norm of one segment of the population and fail to account for the severity of disease in others.

The pandemic has also revealed the biopolitics and even the “necropolitics” of care — when policymakers who are aware that disease and death fall disproportionately in marginal populations make public-health decisions that deepen the risks of exposure of these more vulnerable groups. The question becomes, “Whose lives are deemed disposable?” Similarly, which populations — and which regions of the world — are prioritized for treatment and protective technologies like vaccines and to what degree are such decisions politicized or even racialized?

Although no single change will address all of these disparities in health status and access to treatment, municipal, state, and federal policies aimed at improving the American health infrastructure — and especially those that expand the availability and distribution of medical resources to underserved populations — could greatly improve health for all.

Seth Mnookin , professor of science writing

The Covid-19 pandemic adds yet another depressing data point to how the legacy and reality of racism and white supremacy in America is lethal to historically marginalized groups. A number of recent studies have shown that Black, Hispanic, Asian, and Native Americans have a significantly higher risk of infection, hospitalization, and death compared to white Americans.

The reasons are not hard to identify: Minority populations are less likely to have access to healthy food options, clean air and water, high-quality housing, and consistent health care. As a result, they’re more likely to have conditions that have been linked to worse outcomes in Covid patients, including diabetes, hypertension, and obesity.

Marginalized groups are also more likely to be socioeconomically disadvantaged — which means they’re more likely to work in service and manufacturing industries that put them in close contact with others, use public transportation, rely on overcrowded schools and day cares, and live in closer proximity to other households. Even now, more vaccines are going to wealthier people who have the time and technology required to navigate the time-consuming vaccine signup process and fewer to communities with the highest infection rates.

This illustrates why addressing inequalities in Americans’ health requires addressing inequalities that infect every part of society. Moving forward, our health care systems should take a much more active role in advocating for racial and socioeconomic justice — not only because it is the right thing to do, but because it is one of the most effective ways to improve health outcomes for the country as a whole.

On a global level, the pandemic has illustrated that preparedness and economic resources are no match for lies and misinformation. The United States, Brazil, and Mexico have, by almost any metric, handled the pandemic worse than virtually every other country in the world. The main commonality is that all three were led by presidents who actively downplayed the virus and fought against lifesaving public health measures. Without a global commitment to supporting accurate, scientifically based information, there is no amount of planning and preparation that can outflank the spread of lies.

Parag Pathak , Class of 1922 Professor of Economics   The pandemic has revealed the strengths and weaknesses of America’s health care systems in an extreme way. The development and approval of three vaccines in roughly one year after the start of the pandemic is a phenomenal achievement. At the same time, there are many innovations for which there have been clear fumbles, including the deployment of rapid tests and contact tracing.   The other aspect the pandemic has made apparent is the extreme inequality in America’s health systems. Disadvantaged communities have borne the brunt of Covid-19 both in terms of health outcomes and also economically. I’m hopeful that the pandemic will spur renewed focus on protecting the most vulnerable members of society. A pandemic is a textbook situation in economics of externalities, where an individual’s decision has external effects on others. In such situations, there can be major gains to coordination. In the United States, the initial response was poorly coordinated across states. I think the same criticism applies globally. We have not paid enough attention to population health on a global scale. One lesson I take from the relative success of the response of East Asian countries is that centralized and coordinated health systems are more equipped to manage population health, especially during a pandemic. We’re already seeing the need for international cooperation with vaccine supply and monitoring of new variants. It will be imperative that we continue to invest in developing the global infrastructure to facilitate greater cooperation for the next pandemic.

Prepared by MIT SHASS Communications Editor and designer: Emily Hiestand Consulting editor: Kathryn O'Neill

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Participating in Health Research Studies

What is health research.

• Is Health Research Safe?
• Is Health Research Right for Me?
• Types of Health Research

The term "health research," sometimes also called "medical research" or "clinical research," refers to research that is done to learn more about human health. Health research also aims to find better ways to prevent and treat disease. Health research is an important way to help improve the care and treatment of people worldwide.

Have you ever wondered how certain drugs can cure or help treat illness? For instance, you might have wondered how aspirin helps reduce pain. Well, health research begins with questions that have not been answered yet such as:

"Does a certain drug improve health?"

To gain more knowledge about illness and how the human body and mind work, volunteers can help researchers answer questions about health in studies of an illness. Studies might involve testing new drugs, vaccines, surgical procedures, or medical devices in clinical trials . For this reason, health research can involve known and unknown risks. To answer questions correctly, safely, and according to the best methods, researchers have detailed plans for the research and procedures that are part of any study. These procedures are called "protocols."

An example of a research protocol includes the process for determining participation in a study. A person might meet certain conditions, called "inclusion criteria," if they have the required characteristics for a study. A study on menopause may require participants to be female. On the other hand, a person might not be able to enroll in a study if they do not meet these criteria based on "exclusion criteria." A male may not be able to enroll in a study on menopause. These criteria are part of all research protocols. Study requirements are listed in the description of the study.

A Brief History

While a few studies of disease were done using a scientific approach as far back as the 14th Century, the era of modern health research started after World War II with early studies of antibiotics. Since then, health research and clinical trials have been essential for the development of more than 1,000 Food and Drug Administration (FDA) approved drugs. These drugs help treat infections, manage long term or chronic illness, and prolong the life of patients with cancer and HIV.

Sound research demands a clear consent process. Public knowledge of the potential abuses of medical research arose after the severe misconduct of research in Germany during World War II. This resulted in rules to ensure that volunteers freely agree, or give "consent," to any study they are involved in. To give consent, one should have clear knowledge about the study process explained by study staff. Additional safeguards for volunteers were also written in the Nuremberg Code and the Declaration of Helsinki .

New rules and regulations to protect research volunteers and to eliminate ethical violations have also been put in to place after the Tuskegee trial . In this unfortunate study, African American patients with syphilis were denied known treatment so that researchers could study the history of the illness. With these added protections, health research has brought new drugs and treatments to patients worldwide. Thus, health research has found cures to many diseases and helped manage many others.

Why is Health Research Important?

The development of new medical treatments and cures would not happen without health research and the active role of research volunteers. Behind every discovery of a new medicine and treatment are thousands of people who were involved in health research. Thanks to the advances in medical care and public health, we now live on average 10 years longer than in the 1960's and 20 years longer than in the 1930's. Without research, many diseases that can now be treated would cripple people or result in early death. New drugs, new ways to treat old and new illnesses, and new ways to prevent diseases in people at risk of developing them, can only result from health research.

Before health research was a part of health care, doctors would choose medical treatments based on their best guesses, and they were often wrong. Now, health research takes the guesswork out. In fact, the Food and Drug Administration (FDA) requires that all new medicines are fully tested before doctors can prescribe them. Many things that we now take for granted are the result of medical studies that have been done in the past. For instance, blood pressure pills, vaccines to prevent infectious diseases, transplant surgery, and chemotherapy are all the result of research.

Medical research often seems much like standard medical care, but it has a distinct goal. Medical care is the way that your doctors treat your illness or injury. Its only purpose is to make you feel better and you receive direct benefits. On the other hand, medical research studies are done to learn about and to improve current treatments. We all benefit from the new knowledge that is gained in the form of new drugs, vaccines, medical devices (such as pacemakers) and surgeries. However, it is crucial to know that volunteers do not always receive any direct benefits from being in a study. It is not known if the treatment or drug being studied is better, the same, or even worse than what is now used. If this was known, there would be no need for any medical studies.

• Next: Is Health Research Safe? >>
• Last Updated: May 27, 2020 3:05 PM
• URL: https://guides.library.harvard.edu/healthresearch

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Confronting Challenges in the US Health Care System : Potential Opportunity in a Time of Crisis

• 1 Deputy Editor, JAMA Health Forum
• 2 Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee
• Editorial The Near-Term Future of Health Care Reform Ezekiel J. Emanuel, MD, PhD JAMA
• Editorial Crucial Questions for US Health Policy in the Next Decade John Z. Ayanian, MD, MPP JAMA

The sheer number of challenges facing the Biden Administration and the 117th Congress in the health policy sphere is staggering, as is the range of potential solutions offered by the authors of the Viewpoints in the JAMA Health Policy series. 1 The most pressing challenges involve addressing the global COVID-19 pandemic. Yet policy makers would be remiss if they did not leverage this opportunity to also address the fundamental problems with the US health system laid bare by the nation’s response to the pandemic. These include major challenges related to health insurance coverage, the solvency of publicly funded programs, the stability of the health care safety net, market power and consolidation, inequities in health care access and outcomes, public health infrastructure, and the failure to effectively use technology to help counteract these problems.

Personal health crises, such as experiencing a myocardial infarction, can spur patients and their care teams to work to improve underlying health habits and conditions that contributed to the health event. Similarly, the havoc wrought by the COVID-19 pandemic is a clarion call to improve US health care coverage, financing, and organization. The status quo practices of the health system in the US—like poor health habits of a patient with heart disease—have left it susceptible to poor outcomes.

The high cost of the US health care system is its biggest weakness. In the US, national expenditures on health care goods and services were approximately $4 trillion in 2020, accounting for an estimated 18% of gross domestic product. 2 High prices for care explain a large part of the difference in spending between the US and other developed countries. Surprise billing is just one aspect of the pricing problem, but one that, as Colla 3 describes, illustrates many troubling trends in medicine. Consolidation of hospitals, insurers, and large and small practices has accelerated during the pandemic and as Dafny 4 explains, can be expected to lead to higher prices in the commercial market in the future. Chernew 5 elegantly discusses how market power and consolidation in the health care industry, exacerbated by the pandemic, could lead to still higher prices and a cycle of harms for individuals, governments, and society as a whole.

Those harms include incomplete insurance coverage, both in terms of numbers of people covered and the generosity of that coverage, due to high prices that lead to high insurance premiums. Higher premiums have meant that many people who are not eligible for subsidies on the health insurance exchanges find insurance unaffordable. The Biden campaign proposals to extend subsidies to higher income groups are designed to help solve this problem but will not address its root causes. High premiums have also contributed to wage stagnation for US workers with employment-based health insurance and to higher cost-sharing, which has been shown to reduce access to necessary care.

In addition, higher health care costs put pressure on state and federal budgets. As Gee et 6 al discuss, 12 states have not chosen to expand Medicaid to date, and a concern that even being responsible for 10% of the increased costs could be burdensome is one of the reasons cited for this choice. Frank and Neuman 7 emphasize that the looming deficits in the Medicare Part A Trust Fund will also put pressure on federal policy makers to find sources of new revenues or to cut benefits or payment rates. Perhaps even more important, as described by Venkataramani and colleagues, 8 high health care prices contribute to limited budgets for other social goods like education and housing that could improve health outcomes, possibly even more than direct spending on health care.

Similarly, it is now clear that the US has spent an increasing amount of resources on health care, but spending on public health has been inadequate. Investments in surveillance officers and systems and in stockpiles of equipment and medications are less appealing ways to spend public resources than covering new drugs or services. The pandemic has revealed the shortcomings of the US public health infrastructure and illustrates that neglecting to reinvest in public health after a pandemic will more severely compromise the ability to respond effectively to the next public health crisis. 9 Although none of the Viewpoints in this series focused on specific public health proposals, they should be part of every discussion of improving health and health care going forward. Public health policy must be central not only to health policy, but to economic policy and national security policy as well.

High health care prices might be less of a problem if the US health care system was uniformly delivering high-quality care and yielding high value. The US does prioritize health as a society and voters are reluctant to endorse solutions that limit access to the latest innovations in health care. However, a fundamental shortcoming in the US health care system is the tendency to create and perpetuate incentives to deliver higher-margin treatments and specialty care instead of primary care, preventive care, and public health. The central need to refine the focus on value was highlighted in many articles in the series.

Several Viewpoints in the Health Policy series provided worthy suggestions and policy recommendations the could help the US health care system recover from the current crises stronger. Berwick and Gilfillan 10 call for speeding the cycle time of demonstrations under the Center for Medicare and Medicaid Innovation, Dafny 4 suggests examining mergers and acquisitions more closely, and Chernew 5 proposes implementing “backstop” prices in commercial markets.

Another important step will be using data and technology strategically. During the pandemic, the health care system rapidly adopted telemedicine in clinical care. Millions of people accessed readily available data dashboards that illustrated the course of the pandemic and the extent of infections in specific areas, and many used the information to demand better and more equal care. As described by Adler-Milstein, 11 a digital transformation in the US health care system could make it possible to continuously monitor and use real-time data to inform preparedness and population-level care planning. Such data systems also could be used to help address and reduce disparities and inequities in care and to improve health system transparency, including around prices. Moreover, these systems could save money and reduce the reporting and patient tracking burdens on health care centers, physicians, and other clinicians participating in value-based care; administrative costs are estimated by Kocher et al 12 at $2500 per person per year.

Can commitments to improving health care coverage, financing, and organization be made in the midst of a pandemic and an affordability crisis? There are reasons to hope the answer is yes. The pandemic has substantially changed care patterns, shown the risks of fee-for-service payment and a reliance on highly reimbursed surgical procedures, and revealed the need for a stronger public health infrastructure and greater preparedness. Health systems will be increasingly held accountable for ensuring delivery of high-value care and for addressing health equity issues in ways that do not rely on outdated models of care. No one could have imagined or would wish the current economic, societal, or health care challenges of the COVID-19 pandemic on a new administration or Congress. But all have hope that leaders can confront these crises as potential opportunities for developing solutions to address the ongoing major challenges in the US health care system.

Correction: This article was updated on June 7, 2021, to correct the spelling of Dr Venkataramani’s name in the fifth paragraph.

Corresponding Author: Melinda B. Buntin, PhD, Department of Health Policy, Vanderbilt University School of Medicine, 2525 West End Ave, Ste 1200, Nashville, TN 37203 ( [email protected] ).

Conflict of Interest Disclosures: Dr Buntin reported being an unpaid board member of the Harvard Medical Faculty Practice in Boston, Massachusetts.

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Buntin MB. Confronting Challenges in the US Health Care System : Potential Opportunity in a Time of Crisis . JAMA. 2021;325(14):1399–1400. doi:10.1001/jama.2021.1471

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Research Topics & Ideas: Healthcare

100+ Healthcare Research Topic Ideas To Fast-Track Your Project

Finding and choosing a strong research topic is the critical first step when it comes to crafting a high-quality dissertation, thesis or research project. If you’ve landed on this post, chances are you’re looking for a healthcare-related research topic , but aren’t sure where to start. Here, we’ll explore a variety of healthcare-related research ideas and topic thought-starters across a range of healthcare fields, including allopathic and alternative medicine, dentistry, physical therapy, optometry, pharmacology and public health.

NB – This is just the start…

The topic ideation and evaluation process has multiple steps . In this post, we’ll kickstart the process by sharing some research topic ideas within the healthcare domain. This is the starting point, but to develop a well-defined research topic, you’ll need to identify a clear and convincing research gap , along with a well-justified plan of action to fill that gap.

If you’re new to the oftentimes perplexing world of research, or if this is your first time undertaking a formal academic research project, be sure to check out our free dissertation mini-course. In it, we cover the process of writing a dissertation or thesis from start to end. Be sure to also sign up for our free webinar that explores how to find a high-quality research topic.

Overview: Healthcare Research Topics

• Allopathic medicine
• Alternative /complementary medicine
• Veterinary medicine
• Physical therapy/ rehab
• Optometry and ophthalmology
• Pharmacy and pharmacology
• Public health
• Examples of healthcare-related dissertations

Allopathic (Conventional) Medicine

• The effectiveness of telemedicine in remote elderly patient care
• The impact of stress on the immune system of cancer patients
• The effects of a plant-based diet on chronic diseases such as diabetes
• The use of AI in early cancer diagnosis and treatment
• The role of the gut microbiome in mental health conditions such as depression and anxiety
• The efficacy of mindfulness meditation in reducing chronic pain: A systematic review
• The benefits and drawbacks of electronic health records in a developing country
• The effects of environmental pollution on breast milk quality
• The use of personalized medicine in treating genetic disorders
• The impact of social determinants of health on chronic diseases in Asia
• The role of high-intensity interval training in improving cardiovascular health
• The efficacy of using probiotics for gut health in pregnant women
• The impact of poor sleep on the treatment of chronic illnesses
• The role of inflammation in the development of chronic diseases such as lupus
• The effectiveness of physiotherapy in pain control post-surgery

Topics & Ideas: Alternative Medicine

• The benefits of herbal medicine in treating young asthma patients
• The use of acupuncture in treating infertility in women over 40 years of age
• The effectiveness of homoeopathy in treating mental health disorders: A systematic review
• The role of aromatherapy in reducing stress and anxiety post-surgery
• The impact of mindfulness meditation on reducing high blood pressure
• The use of chiropractic therapy in treating back pain of pregnant women
• The efficacy of traditional Chinese medicine such as Shun-Qi-Tong-Xie (SQTX) in treating digestive disorders in China
• The impact of yoga on physical and mental health in adolescents
• The benefits of hydrotherapy in treating musculoskeletal disorders such as tendinitis
• The role of Reiki in promoting healing and relaxation post birth
• The effectiveness of naturopathy in treating skin conditions such as eczema
• The use of deep tissue massage therapy in reducing chronic pain in amputees
• The impact of tai chi on the treatment of anxiety and depression
• The benefits of reflexology in treating stress, anxiety and chronic fatigue
• The role of acupuncture in the prophylactic management of headaches and migraines

Topics & Ideas: Dentistry

• The impact of sugar consumption on the oral health of infants
• The use of digital dentistry in improving patient care: A systematic review
• The efficacy of orthodontic treatments in correcting bite problems in adults
• The role of dental hygiene in preventing gum disease in patients with dental bridges
• The impact of smoking on oral health and tobacco cessation support from UK dentists
• The benefits of dental implants in restoring missing teeth in adolescents
• The use of lasers in dental procedures such as root canals
• The efficacy of root canal treatment using high-frequency electric pulses in saving infected teeth
• The role of fluoride in promoting remineralization and slowing down demineralization
• The impact of stress-induced reflux on oral health
• The benefits of dental crowns in restoring damaged teeth in elderly patients
• The use of sedation dentistry in managing dental anxiety in children
• The efficacy of teeth whitening treatments in improving dental aesthetics in patients with braces
• The role of orthodontic appliances in improving well-being
• The impact of periodontal disease on overall health and chronic illnesses

Tops & Ideas: Veterinary Medicine

• The impact of nutrition on broiler chicken production
• The role of vaccines in disease prevention in horses
• The importance of parasite control in animal health in piggeries
• The impact of animal behaviour on welfare in the dairy industry
• The effects of environmental pollution on the health of cattle
• The role of veterinary technology such as MRI in animal care
• The importance of pain management in post-surgery health outcomes
• The impact of genetics on animal health and disease in layer chickens
• The effectiveness of alternative therapies in veterinary medicine: A systematic review
• The role of veterinary medicine in public health: A case study of the COVID-19 pandemic
• The impact of climate change on animal health and infectious diseases in animals
• The importance of animal welfare in veterinary medicine and sustainable agriculture
• The effects of the human-animal bond on canine health
• The role of veterinary medicine in conservation efforts: A case study of Rhinoceros poaching in Africa
• The impact of veterinary research of new vaccines on animal health

Topics & Ideas: Physical Therapy/Rehab

• The efficacy of aquatic therapy in improving joint mobility and strength in polio patients
• The impact of telerehabilitation on patient outcomes in Germany
• The effect of kinesiotaping on reducing knee pain and improving function in individuals with chronic pain
• A comparison of manual therapy and yoga exercise therapy in the management of low back pain
• The use of wearable technology in physical rehabilitation and the impact on patient adherence to a rehabilitation plan
• The impact of mindfulness-based interventions in physical therapy in adolescents
• The effects of resistance training on individuals with Parkinson’s disease
• The role of hydrotherapy in the management of fibromyalgia
• The impact of cognitive-behavioural therapy in physical rehabilitation for individuals with chronic pain
• The use of virtual reality in physical rehabilitation of sports injuries
• The effects of electrical stimulation on muscle function and strength in athletes
• The role of physical therapy in the management of stroke recovery: A systematic review
• The impact of pilates on mental health in individuals with depression
• The use of thermal modalities in physical therapy and its effectiveness in reducing pain and inflammation
• The effect of strength training on balance and gait in elderly patients

Topics & Ideas: Optometry & Opthalmology

• The impact of screen time on the vision and ocular health of children under the age of 5
• The effects of blue light exposure from digital devices on ocular health
• The role of dietary interventions, such as the intake of whole grains, in the management of age-related macular degeneration
• The use of telemedicine in optometry and ophthalmology in the UK
• The impact of myopia control interventions on African American children’s vision
• The use of contact lenses in the management of dry eye syndrome: different treatment options
• The effects of visual rehabilitation in individuals with traumatic brain injury
• The role of low vision rehabilitation in individuals with age-related vision loss: challenges and solutions
• The impact of environmental air pollution on ocular health
• The effectiveness of orthokeratology in myopia control compared to contact lenses
• The role of dietary supplements, such as omega-3 fatty acids, in ocular health
• The effects of ultraviolet radiation exposure from tanning beds on ocular health
• The impact of computer vision syndrome on long-term visual function
• The use of novel diagnostic tools in optometry and ophthalmology in developing countries
• The effects of virtual reality on visual perception and ocular health: an examination of dry eye syndrome and neurologic symptoms

Topics & Ideas: Pharmacy & Pharmacology

• The impact of medication adherence on patient outcomes in cystic fibrosis
• The use of personalized medicine in the management of chronic diseases such as Alzheimer’s disease
• The effects of pharmacogenomics on drug response and toxicity in cancer patients
• The role of pharmacists in the management of chronic pain in primary care
• The impact of drug-drug interactions on patient mental health outcomes
• The use of telepharmacy in healthcare: Present status and future potential
• The effects of herbal and dietary supplements on drug efficacy and toxicity
• The role of pharmacists in the management of type 1 diabetes
• The impact of medication errors on patient outcomes and satisfaction
• The use of technology in medication management in the USA
• The effects of smoking on drug metabolism and pharmacokinetics: A case study of clozapine
• Leveraging the role of pharmacists in preventing and managing opioid use disorder
• The impact of the opioid epidemic on public health in a developing country
• The use of biosimilars in the management of the skin condition psoriasis
• The effects of the Affordable Care Act on medication utilization and patient outcomes in African Americans

Topics & Ideas: Public Health

• The impact of the built environment and urbanisation on physical activity and obesity
• The effects of food insecurity on health outcomes in Zimbabwe
• The role of community-based participatory research in addressing health disparities
• The impact of social determinants of health, such as racism, on population health
• The effects of heat waves on public health
• The role of telehealth in addressing healthcare access and equity in South America
• The impact of gun violence on public health in South Africa
• The effects of chlorofluorocarbons air pollution on respiratory health
• The role of public health interventions in reducing health disparities in the USA
• The impact of the United States Affordable Care Act on access to healthcare and health outcomes
• The effects of water insecurity on health outcomes in the Middle East
• The role of community health workers in addressing healthcare access and equity in low-income countries
• The impact of mass incarceration on public health and behavioural health of a community
• The effects of floods on public health and healthcare systems
• The role of social media in public health communication and behaviour change in adolescents

Examples: Healthcare Dissertation & Theses

While the ideas we’ve presented above are a decent starting point for finding a healthcare-related research topic, they are fairly generic and non-specific. So, it helps to look at actual dissertations and theses to see how this all comes together.

Below, we’ve included a selection of research projects from various healthcare-related degree programs to help refine your thinking. These are actual dissertations and theses, written as part of Master’s and PhD-level programs, so they can provide some useful insight as to what a research topic looks like in practice.

• Improving Follow-Up Care for Homeless Populations in North County San Diego (Sanchez, 2021)
• On the Incentives of Medicare’s Hospital Reimbursement and an Examination of Exchangeability (Elzinga, 2016)
• Managing the healthcare crisis: the career narratives of nurses (Krueger, 2021)
• Methods for preventing central line-associated bloodstream infection in pediatric haematology-oncology patients: A systematic literature review (Balkan, 2020)
• Farms in Healthcare: Enhancing Knowledge, Sharing, and Collaboration (Garramone, 2019)
• When machine learning meets healthcare: towards knowledge incorporation in multimodal healthcare analytics (Yuan, 2020)
• Integrated behavioural healthcare: The future of rural mental health (Fox, 2019)
• Healthcare service use patterns among autistic adults: A systematic review with narrative synthesis (Gilmore, 2021)
• Mindfulness-Based Interventions: Combatting Burnout and Compassionate Fatigue among Mental Health Caregivers (Lundquist, 2022)
• Transgender and gender-diverse people’s perceptions of gender-inclusive healthcare access and associated hope for the future (Wille, 2021)
• Efficient Neural Network Synthesis and Its Application in Smart Healthcare (Hassantabar, 2022)
• The Experience of Female Veterans and Health-Seeking Behaviors (Switzer, 2022)
• Machine learning applications towards risk prediction and cost forecasting in healthcare (Singh, 2022)
• Does Variation in the Nursing Home Inspection Process Explain Disparity in Regulatory Outcomes? (Fox, 2020)

Looking at these titles, you can probably pick up that the research topics here are quite specific and narrowly-focused , compared to the generic ones presented earlier. This is an important thing to keep in mind as you develop your own research topic. That is to say, to create a top-notch research topic, you must be precise and target a specific context with specific variables of interest . In other words, you need to identify a clear, well-justified research gap.

Need more help?

If you’re still feeling a bit unsure about how to find a research topic for your healthcare dissertation or thesis, check out Topic Kickstarter service below.

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15 Comments

I need topics that will match the Msc program am running in healthcare research please

Hello Mabel,

I can help you with a good topic, kindly provide your email let’s have a good discussion on this.

Can you provide some research topics and ideas on Immunology?

Thank you to create new knowledge on research problem verse research topic

Help on problem statement on teen pregnancy

This post might be useful: https://gradcoach.com/research-problem-statement/

can you provide me with a research topic on healthcare related topics to a qqi level 5 student

Please can someone help me with research topics in public health ?

Hello I have requirement of Health related latest research issue/topics for my social media speeches. If possible pls share health issues , diagnosis, treatment.

I would like a topic thought around first-line support for Gender-Based Violence for survivors or one related to prevention of Gender-Based Violence

Please can I be helped with a master’s research topic in either chemical pathology or hematology or immunology? thanks

Can u please provide me with a research topic on occupational health and safety at the health sector

Good day kindly help provide me with Ph.D. Public health topics on Reproductive and Maternal Health, interventional studies on Health Education

may you assist me with a good easy healthcare administration study topic

May you assist me in finding a research topic on nutrition,physical activity and obesity. On the impact on children

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• 15 May 2024

Neglecting sex and gender in research is a public-health risk

• Sue Haupt 0 ,
• Cheryl Carcel 1 &
• Robyn Norton 2

Sue Haupt is an honorary senior research fellow at Peter MacCallum Cancer Centre in Melbourne, Australia, and a research associate at The George Institute for Global Health, Women’s Health Program, Centre for Sex and Gender Equity in Health and Medicine, University of New South Wales (UNSW) Sydney, Australia.

You can also search for this author in PubMed   Google Scholar

Cheryl Carcel is the head of the brain health programme at The George Institute for Global Health UNSW Sydney, Australia.

Robyn Norton is a founding director of The George Institute for Global Health, a professor of public health at UNSW Sydney and chair of global health at Imperial College London, UK.

Illustration: Sophi Gullbrants

You have full access to this article via your institution.

In 2022, clinical trials indicated that a drug called lecanemab could slow cognitive decline in people with Alzheimer’s disease; soon after the results were published, the global Alzheimer’s community heralded lecanemab as a momentous discovery. However, closer inspection of the data by independent investigators revealed that the drug might significantly help men, but not women 1 .

The finding is a reminder that, even though tremendous advances are being made in the clinical application of cutting-edge technologies, such as gene editing and artificial intelligence (AI), there is a remarkable lack of understanding about how many aspects of human health are affected by variables as seemingly basic as sex and gender.

Sex and gender in science

Over the past decade or so, funders and publishers have made extensive efforts to encourage researchers to address the effects of sex and, in human studies, gender where appropriate. Thanks in part to these efforts, more insights are beginning to emerge. For Alzheimer’s and many other diseases that are common causes of death, including cardiovascular diseases, cancer, chronic respiratory conditions and diabetes, a person’s sex and gender can influence their risk of developing the disease, how quickly and accurately they are diagnosed, what treatment they receive and how they fare.

But even for the most-studied conditions, many questions remain. Few investigators have begun to probe the interrelationships between sex and gender , for example. And in cases in which researchers are managing to unpick the multifaceted effects of sex, this knowledge is not being sufficiently incorporated into the design of clinical trials or adequately changing the practice of medicine.

The consideration of sex and, where appropriate, gender in biological research must become routine — especially as molecular genetics, biomedical engineering and AI open up possibilities for treatments that are better tailored to the needs of individuals. Likewise, the culture of medicine must be transformed so that approaches to treatment evolve in response to the data. This will require further engagement from funders and publishers, but action from many other players, too. Pharmaceutical companies and intergovernmental organizations, among others, must acknowledge three things: how sex and gender can have huge effects on health outcomes; how these effects are often disregarded in basic research and clinical trials; and that change can come only through increasing awareness among all stakeholders of the importance of shifting the dial.

Health outcomes affected

In most human clinical records so far, sex is reported by physicians or participants in studies ticking one of two boxes: ‘female’ or ‘male’. In those clinical studies in which data are collected on chromosomes, hormone levels, reproductive anatomy or other sex characteristics, these features will frequently reflect a person’s sex assigned at birth. But this is not always the case. Added to this, sex and gender have often been used interchangeably, but they are not the same and they do not always align. Current definitions of gender include the social, psychological, cultural and behavioural aspects of being a man or woman (whether cisgender or transgender), non-binary or identifying with one or more other evolving terms 2 .

In several countries, new recommendations about how researchers should obtain data on people’s sex and gender should mean that, in the future, investigators will be able to more-accurately probe the roles of both in human health. But in general, there has been incomplete capture of information for sex and gender so far, including for individuals whose sex characteristics and/or gender identities don’t fall into a binary categorization scheme.

Women are more likely to die after a severe heart attack than are men. Credit: Simon Dawson/Reuters

In this article, consistent with much of the published population-wide data, we refer to a woman as someone who identifies with that gender and was assigned female sex at birth (a cis woman), and a man as someone who identifies with that gender and was assigned male sex at birth (a cis man). But we recognize that participants in the studies we describe might not have been asked about both their gender and their sex.

For all sorts of non-communicable diseases, there are differences between men and women in the average age at which they are diagnosed, the average age at which they die and even in their rates of death.

We need more-nuanced approaches to exploring sex and gender in research

Such variations, from the earlier onset of cardiovascular diseases in men to the more frequent occurrence of Alzheimer’s disease in women, might stem from differences in biology, which can affect people’s likelihood of developing a disease and how they respond to treatment. Or these discrepancies might stem from variation in people’s exposure to the environmental factors that trigger the disease, how they manage their condition, how they are treated by carers and so on, all of which can be influenced by a person’s gender. Often, a combination of factors will be at work.

Take heart attacks. Studies conducted over the past decade have revealed extensive sex differences in the expression of certain genes in heart tissue, which in turn affect the type and function of the cells that make up the heart.

Such variation could help to explain why men are likely to have a heart attack for the first time around six years earlier than women — in the United States, at 65.6 years old in men compared with 72 years old in women 3 — and why (in Australia, at least) heart attacks are at least twice as common in men relative to women of comparable ages (see go.nature.com/3qbvrxq ). Likewise, although mechanisms are yet to be fully understood, it is plausible that differences in people’s biology help to explain why women are more likely to experience pain between their shoulder blades, nausea or vomiting and shortness of breath during a heart attack; why men are more likely to experience chest pain and increased sweating; and why women are nearly twice as likely as are men to die after a severe heart attack.

Yet, when it comes to the risk of dying, social and environmental factors — shaped by gender — also seem to be important.

Tobacco consumption increases a person’s risk of having a heart attack, and smoking is much more common among men globally. Worldwide, around 37% of men smoke compared with around 8% of women . Also, in part because health-care professionals and others are more familiar with the heart attack symptoms commonly seen in men, when women have a heart attack, they are more likely to delay seeking help, and carers are often slower to intervene 4 . In fact, in a study of more than 500,000 people who experienced a heart attack and were admitted to hospital in the United Kingdom between 2004 and 2013, women were 37% more likely to receive an incorrect initial diagnosis after a severe heart attack than were men 5 . Even when women tell their physicians that they have chest pain, they are two to three times less likely to be referred to a cardiologist than are men 6 .

A similarly complicated picture has been emerging in relation to strokes 7 — another cardiovascular disease — and, in the past few years, in relation to cancer.

Smoking is more common among men than women globally. Credit: Behrouz Mehri/AFP/Getty

Most cancers that occur in non-reproductive organs develop earlier in men than they do in women. In the United States, oesophageal cancer is 4.5 times more likely to occur and cause death in men than in women, for example, and lung cancers, the most common drivers of cancer-associated deaths worldwide, kill around 40% more men than women 8 .

Just as with heart disease and stroke, some of this variation seems to stem from behavioural differences. Tobacco consumption increases a person’s risk of developing several cancers 7 . For thyroid cancers, however, women are more likely to develop the disease than are men — three times more likely in some places — which suggests that other factors might drive the different rates of this particular cancer in women and men 9 . But tumours typically arise because of problems with cells’ genetic-repair systems, together with inadequate damage clearance, and genetic differences between men and women that affect cancers are beginning to emerge.

Male–female comparisons are powerful in biomedical research — don’t abandon them

Much more research is needed to understand how sex affects the rate at which genes mutate, cells’ capacities to repair and clear damaged DNA, and when genetic damage starts causing disease. Yet research led by one of us (S.H.) on lung adenocarcinoma, the most common type of lung cancer, suggests that women can survive for longer than men after they are diagnosed, in part thanks to cancer-defence genes in women driving more-robust immune responses 10 . X chromosomes encode many genes that are linked to immunity, and women with two X chromosomes might express these genes at higher levels than men with XY chromosomes.

Responses to cancer treatments also differ between men and women. Chemotherapies tend to work better in women than in men. This could be because it can take longer for women’s bodies to clear certain drugs, which could partly explain why women are also 34% more likely than men to experience harmful side effects 11 . Moreover, women with lung cancer typically have better outcomes after surgery, which they undergo more often than men 8 . This is probably due, at least in part, to women having less advanced disease when they are diagnosed than men do 12 . But the generally stronger immune responses in women might also help their recovery 8 .

Too often ignored

Despite these compelling indications that sex and gender matter, when it comes to many diseases that are leading causes of death, many researchers and health practitioners still fail to adequately take sex and gender into account. They might also be influenced by conscious or unconscious bias.

In the case of heart disease, the differences in gene expression and cellular make-up and activity found in men and women’s hearts highlight the need for sex-specific cardiac tissue models, sustained by sex-appropriate vasculature 13 . (Women on average have smaller hearts with narrower vessels compared with men.) Currently, researchers tend to construct heart models using either animal or human cells, but without necessarily ensuring that cells are sourced from individuals of only one sex per model. In fact, identifying sex disparities in basic heart biology is crucial to engineering relevant heart models with stem cells, for example, which investigators are now developing to aid the study of heart disease 13 .

For both heart disease and stroke, because of decades of under-representation of women in clinical trials, many of today’s standard treatments are based on studies of what happens in men who weigh around 70 kilograms. In clinical trials conducted for stroke and heart conditions between 2010 and 2017, women worldwide were under-enrolled relative to the prevalence of these diseases in the general population — by around 20% 14 . There is also significant underfunding of research for many conditions that are more prevalent in women compared with those that are more common in men (see ‘Disparities in health and disease’).

Source: A. A. Mirin J. Womens Health 30 , 956–963 (2021).

Basic research on cancer is similarly riddled with problems. Take the sex of the cell lines that are stored in commercial cell banks, which have been studied for decades and are the source of much of today’s textbook knowledge. For lung cancers, male lines outnumber female lines by two to one. For liver cancers, the ratio is seven to one. Until a few years ago, few researchers studying cancer in cultured cells in the lab even considered the sex of the cells they were studying. Also, the standard media in which cells are grown is frequently supplemented with fetal calf serum from a mixture of male and female calves, and so contains both male and female sex hormones. And phenol red, a dye commonly used to monitor the pH of tissue culture media mimics the hormone oestrogen 8 .

To add to the difficulties, research findings that emerge from the use of these cell lines are often tested in mice of only one sex. The results of these studies are then used to guide human trials that include both men and women participants. And in oncological clinical trials, just as with stroke and heart disease, women are still under-enrolled relative to the burden of disease they experience 7 .

Inclusivity in human trials will ensure the best possible outcomes for all participants, including cis and trans women and men, gender-diverse and intersex people (see ‘Inclusivity in practice’). Studies are showing, for example, that circadian rhythms — which can affect heart function and might impact how drugs are metabolized — differ between men and women 15 . So how might they compare in non-binary or transgender people? Likewise, knowledge about the immune responses of people with atypical numbers of sex chromosomes is likely to be crucial when it comes to the use of immune checkpoint inhibitors and other immune therapies for treating cancer. Those with Klinefelter syndrome, for example, who, similar to cis women, are at a higher risk of developing breast cancer than are cis men, have multiple X chromosomes that are rich in genes involved in the immune response.

Inclusivity in practice

How researchers include diverse groups of people in clinical trials with enough participants to be able to uncover between-group differences is a challenge.

Women represent nearly half of the population, but they are still under-represented in many clinical trials for numerous diseases, even in cases in which disease prevalence for women has been measured. For smaller population groups, such as transgender people, there are not enough data to even know what representative inclusion looks like. In fact, even if participation does reflect the prevalence of disease in the broader population in any one trial, teasing out effects might require combining the results of multiple studies in meta-analyses.

Advisory governing boards for pharmaceutical companies, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, funders and regulatory agencies could help with this by ensuring that terminology is adequately and consistently defined, and that populations are properly profiled.

Heightened awareness

Routinely taking sex and gender into account in research and using that knowledge to change health care could benefit billions of people. So what’s needed to make this happen?

Policy changes — such as the US National Institutes of Health’s 2016 call for the inclusion of male and female sexes in studies involving cells, tissues and animals — are crucial. But for many researchers, such calls seem burdensome, especially because studying more than one sex can increase costs. ( Sample sizes might need to be increased to achieve sufficient statistical power when comparing groups.)

Alongside initiatives from funders and publishers, awareness must be built — among students, researchers, clinicians, medical ethics committees, research governance bodies and community groups — of the ramifications of failing to consider sex and gender, and how to correct the problem.

Accounting for sex and gender makes for better science

Efforts led by the Canadian Institutes of Health Research (CIHR) are encouraging. Even though the permeation of knowledge from research to health care has been glacial, between 2011 and 2019, the proportion of all research grant applications submitted to the CIHR that took sex into consideration increased from around 22% to 83%. Gender as a variable is now also included in many of the human studies funded by the CIHR .

Several initiatives have contributed to this. As an example, as well as asking grant applicants to include a section in their research proposals on whether they are considering sex and gender and how they will do so, or why this is not considered applicable, the CIHR has provided training for scientists and organized workshops involving researchers and specialists in sex and gender. Applicants are more likely to receive funding if they provide a satisfactory rationale for their choices.

Convincing people in leadership roles — in governments, laboratories, medical ethics boards, education and so on — of the importance of including sex and gender in research is especially crucial. More studies demonstrating the financial costs of not doing so could help. Between 1997 and 2000, for instance, eight prescription drugs were retracted from the US market because inadequate clinical testing in women had failed to identify that the drugs put women at greater risk of developing health problems than men. This error cost pharmaceutical companies and taxpayers an estimated US$1.6 billion per drug 16 .

The scale of transformation needed will also require more engagement from global players.

Even as far back as 2007, the 60th World Health Assembly — the decision-making body of the World Health Organization (WHO) — passed a resolution to urge researchers to split their data according to sex and to include gender analyses where appropriate. Steps to improve care for transgender people or those with diverse genders are also starting to be taken; in December last year, the WHO established a Guideline Development Group, to provide recommendations on how to address the health of transgender and gender-diverse people . But more extensive efforts, comparable to all United Nations member states committing to target 5.b of the 2015 Sustainable Development Goals by 2030, will be crucial. (This target is to “enhance the use of enabling technology, in particular information and communications technology, to promote the empowerment of women”.)

Lastly, under the guidance of regulatory bodies such as the European Medicines Agency and the scientific entrepreneur community, the pharmaceutical industry must do more to ensure that preclinical work is robust, and that products are tested on enough people of different sexes and genders. Many leading pharmaceutical companies acknowledge on their websites the importance of including diverse groups in clinical trials , but evidence of actions to address the issue is only just emerging.

Awareness of the problems around sex and gender is growing fast. And although many are concerned that medical applications of AI will perpetuate already existing biases 17 , promising developments are emerging in the use of machine learning to make diagnoses that are appropriate for people’s sex and gender.

For decades, for instance, physicians worldwide have been determining whether a person has had a heart attack by using the Global Registry of Acute Coronary Events (GRACE) score, which was derived from trials mainly involving men. In 2022, the application of machine learning to data that had been split for men and women refined the predictors for women. And these revised predictors did a better job of matching individuals to appropriate interventions 18 .

Greater awareness, the wealth of data now emerging and the possibilities presented by new tools, from AI to gene editing, could mean a new era for research and medicine.

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Basic Research Powers the First Medication for Postpartum Depression

May 14, 2024 • Feature Story • 75th Anniversary

At a Glance

• Postpartum depression (PPD) is a common mental disorder that many women experience after giving birth.
• Onset of PPD coincides with a dramatic drop in levels of a brain-derived steroid (neurosteroid) known as allopregnanolone.
• Decades of research supported by NIMH illuminated the role of neurosteroids like allopregnanolone in mental illnesses.
• In 2019, brexanolone—a medication that acts by mimicking allopregnanolone—became the first approved drug to treat PPD.
• Able to significantly and rapidly reduce PPD symptoms, brexanolone was a major leap forward in depression treatment.

Joshua A. Gordon, M.D., Ph.D., a practicing psychiatrist at the time, would never forget the call he received one night from a distraught mother.

“She was plagued with a deep, inescapable hopelessness—so depressed she was afraid she was going to hurt her month-old daughter. I helped her get to the hospital, where she spent the next 2 months in an in-patient program trying every available treatment to recover,” said Dr. Gordon, now the Director of the National Institute of Mental Health (NIMH).

Unfortunately, this experience is not uncommon among women and other postpartum people who may feel intense sadness, anxiety, and loss of interest after giving birth. These symptoms can be signs of a clinical disorder known as postpartum depression (PPD) . Unlike the "baby blues" or feelings of sadness many new mothers experience in the days after delivery, PPD is more intense and long-lasting, with damaging impacts on health and well-being.

More than the blues: Impacts of PPD on women's mental health

Depression is a common but serious mood disorder. According to the Centers for Disease Control and Prevention (CDC), rates of depression are high—and rising—among postpartum women. Using data from the 2018 Pregnancy Risk Assessment Monitoring System  , the CDC found that about 1 in 8 postpartum women had symptoms of depression, while another CDC study  showed rates of PPD that were seven times higher in 2015 compared to 2000.

Depression can happen to anyone, and it's especially tough for new moms dealing with the physical challenges of childbirth and the stresses of caring for a young child. When women experience PPD, they often have strong feelings of sadness, anxiety, worthlessness, and guilt. Their sleep, eating, thoughts, and actions can all change noticeably. These mood and behavior changes can be highly distressing and even life-threatening, making it difficult for a woman to do everyday things and take care of herself or her child. In extreme cases, women with PPD may be at risk of hurting themselves or their child or attempting suicide.

Fast-acting, effective treatment for PPD can be life-changing and potentially lifesaving. However, for too long, such care was hard to reach, leaving many women to struggle with depression at a pivotal point in life. Despite some similarities, PPD is not the same as major depression at other times in life. Because of this, usual depression treatments are much less effective in managing the symptoms of PPD.

“PPD is very difficult to treat,” said Mi Hillefors, M.D., Ph.D., Deputy Director of the NIMH Division of Translational Research. “It is usually treated with medications originally approved for major depression—despite limited evidence that they are effective in treating PPD. Standard depression treatments, including antidepressants, psychotherapy, and brain stimulation therapy, can also take weeks or longer to work.”

PPD’s unique risk factors reflect the physical changes of pregnancy and the postpartum period, which include dramatic changes in levels of many hormones and other molecules.

These biological changes had long been seen as a possible source of postpartum mood disorders like depression. But could they also be a solution?

Unlocking the power of allopregnanolone through basic research

Some psychiatric medications owe their discovery to chance. Not so with brexanolone, the first-ever medication to specifically treat PPD. Brexanolone culminated a long series of research studies, much of it funded by NIMH as part of its commitment to understand and support women’s mental health .

Thanks to NIMH-supported basic research, brexanolone was developed by design—a design centered around a molecule called allopregnanolone  .

Allopregnanolone is a steroid naturally produced in the brain and with important actions there, such as regulating neurotransmitter activity and protecting neurons from damage. Its impact extends to mental health, with higher levels linked to better mood, lower anxiety, and reduced depression  .

Allopregnanolone is also important to pregnancy  , during which its levels are extremely high. This happens because of the enhanced production of a hormone called progesterone, which prepares the body for pregnancy and childbirth.

In the last few months of pregnancy, the ovaries and placenta make more progesterone, causing a huge rise in allopregnanolone levels. These levels then drop rapidly after birth. Because allopregnanolone plays a crucial role in mood, these ups and downs can impact a woman’s mental health during and after pregnancy.

Researchers had been aware of brain-derived steroids like allopregnanolone as far back as the 1940s. But the journey to a new PPD treatment began within NIMH's Intramural Research Program (IRP) . At the helm was the NIMH Scientific Director at that time, Steven Paul, M.D., who collaborated with researchers in the NIMH Clinical Neuroscience Branch and at other NIH institutes, including the National Institute of Neurological Disorders and Stroke (NINDS). The researchers sought to understand how the steroids work, change over time, respond to stress, and ultimately relate to health and disease.

Early discoveries came in the 1980s. Paul, working with Maria Majewska, Ph.D., Jacqueline Crawley, Ph.D., A. Leslie Morrow, Ph.D., and other researchers showed that hormones such as progesterone and molecules derived from them have calming and anxiety-reducing effects  . Extensive research by Paul’s lab showed that these anxiolytic effects come from enhancing the activity of GABA  by binding to specific sites on its receptor. As the main inhibitory neurotransmitter (chemical messenger), GABA reduces the activity of neurons, making them less likely to fire. When molecules bind to its receptor, GABA becomes more potent at inhibiting electrical activity  in the brain, with calming effects on behavior.

Paul and IRP colleague Robert Purdy, Ph.D., used the term “ neuroactive steroids  ,” or neurosteroids, to describe these molecules able to bind to receptors in the brain to rapidly alter neuronal excitability. Their work in animals confirmed that allopregnanolone is synthesized in the brain  . They also showed the effects of allopregnanolone on GABA receptors in humans. Moreover, they found that allopregnanolone affects the response to stress  , with acute stress leading the neurosteroid to increase to levels that alter GABA activity. These findings suggested that neurosteroids play an important role in helping animals “reset” and adaptively respond to stressful life events.

Together, this IRP-conducted research established the importance of neurosteroids via their presence in the brain, ability to reduce neuronal activity, and release during stress. Although much of this work was conducted in animals, it would spotlight neurosteroids—and allopregnanolone in particular—as promising targets for treating mental disorders, eventually opening the door to their therapeutic use in humans.

Bridging the gap to advance clinical intervention

While NIMH intramural researchers were making remarkable strides, researchers at other institutions were also conducting work bolstered by funding from NIMH. Among them were Alessandro Guidotti, M.D., at the University of Illinois at Chicago; Istvan Mody, Ph.D., at the University of California, Los Angeles; and Charles Zorumski, M.D., at Washington University in St. Louis. Their NIMH-funded research propelled understanding of inhibitory neurosteroids and their importance in reducing the adverse effects of stress. This work would be the impetus for homing in on allopregnanolone as a treatment for PPD.

Guidotti and colleagues conducted several NIMH-funded studies. Their research in rodents confirmed that allopregnanolone is produced in the brain  and helps regulate neuronal excitability  by acting on GABA receptors. They also built on the knowledge that neurosteroids are affected by stress. However, unlike acute stress, a stressor lasting multiple weeks led to a decrease in allopregnanolone  in brain areas involved in anxiety- and depression-like behaviors.

Importantly, their NIMH-funded work offered some of the earliest evidence that allopregnanolone contributes to depression by showing significantly lower levels  in people with depression compared to people without the disorder, a rise in levels (but not that of other neurosteroids) after treatment with antidepressant medication  , and a link between increased levels and reduced depression symptoms  .

NIMH and NINDS funded multiple studies by Mody and colleagues on interactions of neurosteroids, stress, and GABA receptors. This research was integral to understanding a mechanism in the brains of mice  that might explain why some people become depressed after childbirth. Their NIMH-supported research  showed changes in GABA receptors in the brain, where neurosteroids are active, that impaired the body’s ability to adapt to hormonal fluctuations. Animals with an irregular GABA receptor component lacking sensitivity to neurosteroids showed depression-like behaviors and reduced maternal care; treating them with a drug that restored the receptor’s function reversed those changes.

Another study by Mody and colleagues  revealed changes in GABA expression during pregnancy that led to greater neuronal activity in the brain—but could be brought down by allopregnanolone. This finding opened the door to future studies exploring whether a postpartum drop in the neurosteroid contributed to the risk for mood disorders after birth.

Zorumski led a team in extensively studying neurosteroids as well. Among their seminal findings was identifying the mechanisms by which inhibitory neurosteroids like allopregnanolone affect GABA receptor activity  . Their NIMH-funded work dramatically augmented knowledge of how neurosteroids alter GABA receptors to contribute to the risk for mental disorders like PPD.

“The accumulated evidence from these studies established the necessary bridges to justify examining a potential therapeutic role for allopregnanolone in women with PPD,” said Peter Schmidt, M.D., Chief of the NIMH Behavioral Endocrinology Branch.

By the 2010s, researchers had a much better understanding of how allopregnanolone is linked to PPD. Studies showed decreased allopregnanolone in pregnant  and postpartum  women with symptoms of depression and higher allopregnanolone associated with a lower risk of PPD  . The possibility that PPD might be caused by the downregulation of GABA receptors in response to low levels of allopregnanolone after birth inspired researchers to put that theory to the test in clinical studies with human participants.

Taking allopregnanolone from bench to bedside

Extensive research, supported by NIMH and other NIH institutes, found that neurosteroids play a key role in how people deal with stress. They also contribute to the development of mood disorders like anxiety and depression. For allopregnanolone, evidence that it sharply decreases after pregnancy and regulates GABA activity gave rise to the notion that it contributes to PPD—and inspired hope it could be used to treat the disorder.

The biopharmaceutical company Sage Therapeutics utilized this basic research to develop brexanolone. Administered intravenously by a health care professional in a doctor’s office or clinic, brexanolone mimics the effects of allopregnanolone, increasing the inhibitory actions of GABA receptors.

Stephen Kanes, M.D., Ph.D., at Sage Therapeutics and Samantha Meltzer-Brody, M.D., MPH, at the University of North Carolina led several randomized clinical trials to measure the effectiveness of the medication in treating PPD and evaluate its safety and tolerability. The studies, which recruited adult women with PPD from hospitals, research centers, and psychiatric clinics across the United States, measured the effects of brexanolone compared to a placebo over 4 weeks.

The trials were a success. Brexanolone significantly and meaningfully reduced PPD symptoms  , and it had only mild side effects. Compared to usual depression treatments, brexanolone brought about a faster response and greater improvement  . Whereas most antidepressants take weeks to work, brexanolone improved symptoms and functioning in women with PPD within a few hours to days. And the effects lasted up to a month after the treatment stopped. Not only was brexanolone more effective, but it also worked faster than other depression medications.

“The dramatic impact of basic research on real-world health outcomes has been inspiring. The fact that NIMH-supported studies contributed to successful drug development in a matter of decades is a remarkable feat and a powerful demonstration of the potential of this foundational research,” said Dr. Gordon.

Based on this promising evidence, the U.S. Food and Drug Administration (FDA) gave brexanolone priority review and breakthrough therapy designation in September 2016. Then, in March 2019, the FDA approved brexanolone  , making it the first drug to treat PPD.

Brightening the future for women with PPD

For women with PPD, brexanolone was a long-awaited reason to celebrate. For NIMH, it was a testament to discoveries made through the decades of research it supported. Although some barriers to treatment persisted, women now had greater hope for treating depression symptoms after pregnancy.

“The approval of brexanolone was an important milestone. Finally, an effective, fast-acting medication specifically to treat PPD,” said Dr. Hillefors. “It was also a victory for psychiatric neuroscience because basic and translational research—by design, not chance—led to a truly novel and effective treatment for a psychiatric disorder.”

Without NIMH-supported studies providing the foundational knowledge of neurosteroids, researchers may have never made the connection between allopregnanolone and treating PPD. “That’s why the approval of brexanolone is such a cause for celebration for mental health research: It represents a true bench-to-bedside success,” said Dr. Gordon.

The success of brexanolone has continued to open the door to exciting advancements in mental health care. For instance, researchers and clinicians are investigating ways to make brexanolone work better for all postpartum people. Researchers are also testing how neurosteroids can be used to treat other forms of depression and other mental health conditions.

Just the beginning of treatment advances for PPD

Brexanolone is only the start of what will hopefully be a new future for PPD treatment. In August 2023, the FDA approved zuranolone  as the first oral medication for PPD. Zuranolone acts via similar biological mechanisms as brexanolone. Its approval reflects the next step in NIMH-supported basic research being translated into clinical practice with real-world benefits.

The success of the drug, which is taken in pill form, was shown in two randomized multicenter clinical trials  . Women with severe PPD who received zuranolone showed statistically significant and clinically meaningful improvements in depression symptoms compared to women who received a placebo. These effects were rapid, sustained through 45 days, and seen across a range of clinical measures. The benefits were mirrored in patients’ self-assessment of their depression symptoms.

According to Dr. Schmidt, “The approval of zuranolone to treat PPD provides women with a rapid and effective treatment that avoids some of the limitations of the original intravenous medication.”

And the journey is far from over. Researchers, clinicians, and industry are continuing to innovate new treatments for PPD to increase access and availability to ensure all people can receive help for their postpartum symptoms.

“While I will never forget that phone call from my patient, the development of these effective medications brings us hope for helping people with PPD and for the overall impact of basic research to truly make a difference in people’s lives,” concluded Dr. Gordon.

Publications

Burval, J., Kerns, R., & Reed, K. (2020). Treating postpartum depression with brexanolone. Nursing , 50 (5), 48−53. https://doi.org/10.1097/01.NURSE.0000657072.85990.5a  

Cornett, E. M., Rando, L., Labbé, A. M., Perkins, W., Kaye, A. M., Kaye, A. D., Viswanath, O., & Urits, I. (2021). Brexanolone to treat postpartum depression in adult women. Psychopharmacology Bulletin , 51 (2), 115–130. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8146562/pdf/PB-51-2-115.pdf 

Deligiannidis, K. M., Meltzer-Brody, S., Maximos, B., Peeper, E. Q., Freeman, M., Lasser, R., Bullock, A., Kotecha, M., Li, S., Forrestal, F., Rana, N., Garcia, M., Leclair, B., & Doherty, J. (2023). Zuranolone for the treatment of postpartum depression. American Journal of Psychiatry , 180 (9), 668−675. https://doi.org/10.1176/appi.ajp.20220785  

Deligiannidis, K. M., Kroll-Desrosiers, A. R., Mo, S., Nguyen, H. P., Svenson, A., Jaitly, N., ... & Shaffer, S. A. (2016). Peripartum neuroactive steroid and γ-aminobutyric acid profiles in women at-risk for postpartum depression. Psychoneuroendocrinology , 70 , 98−107. https://doi.org/10.1016/j.psyneuen.2016.05.010  

Edinoff, A. N., Odisho, A. S., Lewis, K., Kaskas, A., Hunt, G., Cornett, E. M., Kaye, A. D., Kaye, A., Morgan, J., Barrilleaux, P. S., Lewis, D., Viswanath, O., & Urits, I. (2021). Brexanolone, a GABAA modulator, in the treatment of postpartum depression in adults: A comprehensive review. Frontiers in Psychiatry , 12 , Article 699740. https://doi.org/10.3389/fpsyt.2021.699740  

Epperson, C. N., Rubinow, D. R., Meltzer-Brody, S., Deligiannidis, K. M., Riesenberg, R., Krystal, A.D., Bankole, K., Huang, M. Y., Li, H., Brown, C., Kanes, S. J., & Lasser R. (2023). Effect of brexanolone on depressive symptoms, anxiety, and insomnia in women with postpartum depression: Pooled analyses from 3 double-blind, randomized, placebo-controlled clinical trials in the HUMMINGBIRD clinical program. Journal of Affective Disorders , 320 , 353−359. https://doi.org/10.1016/j.jad.2022.09.143  

Gilbert Evans, S. E., Ross, L. E., Sellers, E. M., Purdy, R. H., & Romach, M. K. (2005). 3α-reduced neuroactive steroids and their precursors during pregnancy and the postpartum period. Gynecological Endocrinology , 21 (5), 268−279. https://doi.org/10.1080/09513590500361747  

Guintivano, J., Manuck, T., & Meltzer-Brody, S. (2018). Predictors of postpartum depression: A comprehensive review of the last decade of evidence. Clinical Obstetrics and Gynecology , 61 (3), 591−603. https://doi.org/10.1097/GRF.0000000000000368  

Gunduz-Bruce, H., Koji, K., & Huang, M.-Y. (2022). Development of neuroactive steroids for the treatment of postpartum depression. Journal of Neuroendocrinology , 34 (2), Article e13019. https://doi.org/10.1111/jne.13019  

Haight, S. C., Byatt, N., Moore Simas, T. A., Robbins, C. L., & Ko, J. Y. (2019). Recorded diagnoses of depression during delivery hospitalizations in the United States, 2000-2015. Obstetrics and Gynecology , 133 (6), 1216−1223. https://doi.org/10.1097/AOG.0000000000003291  

Hellgren, C., Åkerud, H., Skalkidou, A., Bäckström, T., & Sundström-Poromaa, I. (2014). Low serum allopregnanolone is associated with symptoms of depression in late pregnancy. Neuropsychobiology , 69 (3), 147–153. https://doi.org/10.1159/000358838  

Hutcherson, T. C., Cieri-Hutcherson, N. E., & Gosciak, M. F. (2023). Brexanolone for postpartum depression. American Journal of Health-System Pharmacy , 77 (5), 336−345. https://doi.org/10.1093/ajhp/zxz333  

Kanes, S., Colquhoun, H., Gunduz-Bruce, H., Raines, S., Arnold, R., Schacterle, A., Doherty, J., Epperson, C. N., Deligiannidis, K. M., Riesenberg, R., Hoffmann, E., Rubinow, D., Jonas, J., Paul, S., & Meltzer-Brody, S. (2017). Brexanolone (SAGE-547 injection) in post-partum depression: A randomised controlled trial. The Lancet , 390(10093), 480−489. https://doi.org/10.1016/S0140-6736(17)31264-3  

Leader, L. D., O'Connell, M., & VandenBerg, A. (2019). Brexanolone for postpartum depression: Clinical evidence and practical considerations. Pharmacotherapy , 39 (11), 1105–1112. https://doi.org/10.1002/phar.2331  

Maguire, J., & Mody, I. (2008). GABAAR plasticity during pregnancy: Relevance to postpartum depression. Neuron , 59 (2), P207–P213. https://doi.org/10.1016/j.neuron.2008.06.019  

Maguire, J., & Mody, I. (2016). Behavioral deficits in juveniles mediated by maternal stress hormones in mice. Neural Plasticity , Article 2762518. https://doi.org/10.1155/2016/2762518  

Majewska, M. D., Harrison, N. L., Schwartz, R. D., Barker, J. L., & Paul, S. M. (1986). Steroid hormone metabolites are barbiturate-like modulators of the GABA receptor. Science , 232 (4753), 1004−1007. https://doi.org/10.1126/science.2422758  

McEvoy, K., & Osborne, L. M. (2019). Allopregnanolone and reproductive psychiatry: An overview. International Review of Psychiatry , 31 (3), 237–244. https://doi.org/10.1080/09540261.2018.1553775  

Meltzer-Brody, S., Colquhoun, H., Riesenberg, R., Epperson, C. N., Deligiannidis, K. M., Rubinow, D. R., Li, H., Sankoh, A. J., Clemson, C., Schacterle, A., Jonas, J., & Kanes, S. (2018). Brexanolone injection in post-partum depression: Two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. The Lancet , 392 (10152), 1058−1070. https://doi.org/10.1016/S0140-6736(18)31551-4  

Morrison, K. E., Cole, A. B., Thompson, S. M., & Bale, T. L. (2019). Brexanolone for the treatment of patients with postpartum depression. Drugs Today , 55 (9), 537–544. https://doi.org/10.1358/dot.2019.55.9.3040864  

Purdy, R. H., Morrow, A. L., Moore, P. H., & Paul, S. M. (1991). Stress-induced elevations of gamma-aminobutyric acid type A receptor-active steroids in the rat brain. Proceedings of the National Academy of Sciences , 88 (10), 4553−4557. https://doi.org/10.1073/pnas.88.10.4553  

Scarff, J. R. (2019). Use of brexanolone for postpartum depression. Innovations in Clinical Neuroscience , 16 (11−12), 32–35.

Schüle, C., Nothdurfter, C., & Rupprecht, R. (2014). The role of allopregnanolone in depression and anxiety. Progress in Neurobiology , 113 , 79−87. https://doi.org/10.1016/j.pneurobio.2013.09.003  

Selye, H. (1941). Anesthetic effect of steroid hormones. Experimental Biology and Medicine , 46 (1), 116–121. https://doi.org/10.3181/00379727-46-11907  

Shorey, S., Chee, C. Y. I., Ng, E. D., Chan, Y. H., Tam, W. W. S., & Chong, Y. S. (2018). Prevalence and incidence of postpartum depression among healthy mothers: A systematic review and meta-analysis. Journal of Psychiatric Research , 104 , 235–248. https://doi.org/10.1016/j.jpsychires.2018.08.001  

Slomian, J., Honvo, G., Emonts, P., Reginster, J. Y., & Bruyère, O. (2019). Consequences of maternal postpartum depression: A systematic review of maternal and infant outcomes. Women's Health , 15 , 1−55. https://doi.org/10.1177/1745506519844044  

• Perinatal Depression (NIMH brochure)
• Depression in Women: 4 Things You Should Know (NIMH health topic page)
• Depression (NIMH health topic page)
• Major Depression (NIMH statistics page)
• Women and Mental Health (NIMH health topic page)
• A Bench-to-Bedside Story: The Development of a Treatment for Postpartum Depression (NIMH Director’s Message)
• Bench-to-Bedside: NIMH Research Leading to Brexanolone, First-Ever Drug Specifically for Postpartum Depression (NIIMH press release)
• Population Study Finds Depression Is Different Before, During, and After Pregnancy (NIMH research highlight)
• FDA Approves First Treatment for Post-Partum Depression  (FDA news release)
• FDA Approves First Oral Treatment for Postpartum Depression  (FDA news release)

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Federal Task Force Releases National Strategy to Improve Maternal Mental Health Care, Includes Medicaid Policies

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This week the Task Force on Maternal Mental Health released a national strategy to improve maternal health care and an accompanying report to Congress . The federal interagency task force was created under the Consolidated Appropriations Act, 2023 for purposes of identifying, evaluating, and making recommendations to coordinate and improve federal activities related to addressing maternal mental health conditions.

The national strategy consists of five pillars under which priorities and recommendations are organized:

• Build a National Infrastructure That Prioritizes Perinatal Mental Health and Well-Being
• Make Care and Services Accessible, Affordable, and Equitable
• Use Data and Research to Improve Outcomes and Accountability
• Promote Prevention and Engage, Education, and Partner with Communities
• Lift Up Lived Experience

As highlighted in our report on State Medicaid Opportunities to Support Mental Health of Mothers and Babies During the 12-Month Postpartum Period , Medicaid plays a timely and vital role in meeting the mental health needs of pregnant and postpartum individual as the predominant payer of U.S. births and coverage source for low-income infants. Notably, national birth data from the Centers for Disease Control and Prevention show that more than two-thirds (64%) of Black mothers and more than half (58%) of Hispanic mothers had Medicaid coverage reported on birth certificates in 2021. Accordingly, the program’s role and reach is critical to both financing care and spurring needed health systems changes – changes that are woefully needed as demonstrated by recent Maternal Mental Health State Report Cards finding that 29 states earned Ds and Fs in 2024.

The Task Force’s national strategy and report recognize the important role Medicaid plays in meeting maternal mental health needs with multiple recommendations to Congress and/or federal agencies focused on Medicaid policies , including:

• Requiring all states, DC and the territories to expand Medicaid and Children’s Health Insurance Program (CHIP) coverage from 60 days to 12 months postpartum, as well as providing information on how to use these benefits to providers, patients, and communities.
• Requiring and/or encouraging all states, DC and the territories to provide Medicaid coverage of nonclinical support staff members, such as community health workers , doulas , health navigators, peer support specialists, lactation consultants, and gender-based counselors/specialists.
• Requiring all states, DC and the territories to provide Medicaid coverage for dyadic family mental health and substance use disorder services and ensure that providers can bill for services provided to both the mother and the baby during the same visit.
• Ensuring compliance with the SUPPORT Act requirement that state Medicaid programs cover all FDA-approved forms of medication for the treatment of opioid use disorders and related counseling and therapy.
• Incentivizing states to increase Medicaid reimbursement rates and/or providing incentive payments that could supplement current rates for maternity and/or mental health and substance use disorder care.
• Encouraging states to adopt recent Medicaid guidance on interprofessional consultation .
• Requiring states to report on the entire Medicaid Adult Cores Set (rather than just the behavioral health measures and the Child Core Set).
• Ensuring Medicaid coverage of evidence-based best practices and programs that promote person-centered, culturally relevant, and community-level detection and prevention of perinatal mental health conditions and substance use disorders.

The national strategy is deemed a living document by its creators and will be updated regularly until the task force sunsets in 2027. Updates will include a report that details steps for implementation of the recommendations as well as a resource for governors diving deeper into state policy opportunities.

For the full list of recommendations along with best practices and other resources to support maternal mental health and substance use disorders, check out the national strategy and corresponding report to Congress . In addition, to see where your state lands on maternal mental health care – including providers and programs, screening and screening reimbursement, and insurance coverage and treatment – check out your state’s 2024 Maternal Mental Health State Report Card .

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Reproductive rights in America

Despite state bans, abortions nationwide are up, driven by telehealth.

Elissa Nadworny

Abortion rights activists at the Supreme Court in Washington, D.C. on March 26, the day the case about the abortion drug mifepristone was heard. The number of abortions in the U.S. increased, a study says, surprising researchers. Drew Angerer/AFP via Getty Images hide caption

Abortion rights activists at the Supreme Court in Washington, D.C. on March 26, the day the case about the abortion drug mifepristone was heard. The number of abortions in the U.S. increased, a study says, surprising researchers.

In the 18 months following the Supreme Court's decision that ended federal protection for abortion, the number of abortions in the U.S. has continued to grow, according to The Society of Family Planning's WeCount project .

"We are seeing a slow and small steady increase in the number of abortions per month and this was completely surprising to us," says Ushma Upadhyay , a professor and public health scientist at the University of California, San Francisco who co-leads the research. According to the report, in 2023 there were, on average, 86,000 abortions per month compared to 2022, where there were about 82,000 abortions per month. "Not huge," says Upadhyay, "but we were expecting a decline."

Shots - Health News

What's at stake in the supreme court mifepristone case.

The slight increase comes despite the fact that 14 states had total abortion bans in place during the time of the research. According to the report, there were about 145,000 fewer abortions in person in those states since the Dobbs decision, which triggered many of the restrictive state laws.

"We know that there are people living in states with bans who are not getting their needed abortions," says Upadhyay. "The concern we have is that that might be overlooked by these increases."

Florida, California and Illinois saw the largest surges in abortions, which is especially interesting given Florida's recent 6-week ban that started on May 1.

Abortion rights opponents demonstrate in New York City, on March 23. Some states' abortion bans are known as "heartbeat bills," because they make abortion illegal after cardiac activity starts, usually around six weeks of pregnancy. Kena Betancur/AFP via Getty Images hide caption

Abortion rights opponents demonstrate in New York City, on March 23. Some states' abortion bans are known as "heartbeat bills," because they make abortion illegal after cardiac activity starts, usually around six weeks of pregnancy.

The latest report also captures for the first time the impact of providers offering telehealth abortions from states with protections for doctors and clinics known as shield laws – statutes that say they can't be prosecuted or held liable for providing abortion care to people from other states.

Between July and December 2023, more than 40,000 people in states with abortion bans and telehealth restrictions received medication abortion through providers in states protected by shield laws. Abortion pills can be prescribed via telehealth appointments and sent through the mail; the pills can safely end pregnancies in the first trimester.

The report includes abortions happening within the U.S. health care system, and does not include self-managed abortions, when people take pills at home without the oversight of a clinician. For that reason, researchers believe these numbers are still an undercount of abortions happening in the U.S.

Tessa Longbons Cox is a senior research associate at Charlotte Lozier Institute, a research organization that opposes abortion. She says the WeCount report, "highlights a concerning trend" that policies around mail-order abortion pills are boosting abortion rates. "By recklessly removing in-person medical visits and safeguards, abortion advocates have put women's health and safety last," Longbons Cox says in a statement.

Accounting for the increases

A major factor in the uptick in abortions nationwide is the rise of telehealth, made possible in part by regulations first loosened during the coronavirus pandemic.

According to the report, telehealth abortions now make up 19% of all abortions in the U.S. In comparison, the first WeCount report which spanned April 2022 through August 2022 showed telehealth abortions accounted for just 4% of all abortions. Research has shown that telehealth abortions are as safe and effective as in-clinic care.

"It's affordable, it's convenient, and it feels more private," says Jillian Barovick, a midwife in Brooklyn and one of the co-founders of Juniper Midwifery , which offers medication abortion via telehealth to patients in six states where abortion is legal. The organization saw its first patient in August 2022 and now treats about 300 patients a month.

A Supreme Court abortion pill case with potential consequences for every other drug

"Having an in-clinic abortion, even a medication abortion, you could potentially be in the clinic for hours, whereas with us you get to sort of bypass all of that," she says. Instead, patients can connect with a clinician using text messages or a secure messaging platform. In addition to charging $100 dollars for the consultation and medication – which is well below the average cost of an abortion – Barovick points to the cost savings of not having to take off work or arrange child care to spend multiple hours in a clinic.

She says her patients receive their medication within 1 to 4 business days, "often faster than you can get an appointment in a clinic."

A study published in JAMA Internal Medicine on Monday followed about 500 women who had medication abortions with the pills distributed via mail order pharmacy after an in-person visit with a doctor. More than 90% of the patients were satisfied with the experience; there were three serious adverse events that required hospitalization.

In addition to expansions in telehealth, there have been new clinics in states like Kansas, Illinois and New Mexico, and there's been an increase in funding for abortion care – fueled by private donors and abortion funds.

The impact of shield laws

During the period from October to December 2023, nearly 8,000 people per month in states with bans or severe restrictions accessed medication abortions from clinicians providing telehealth in the 5 states that had shield laws at the time. That's nearly half of all monthly telehealth abortions.

"It's telemedicine overall that is meeting the need of people who either want to or need to remain in their banned or restricted state for their care," says Angel Foster, who founded The MAP, a group practice operating a telehealth model under Massachusetts' shield laws. "If you want to have your abortion care in your state and you live in Texas or Mississippi or Missouri, right now, the shield law provision is by far the most dominant way that you'd be able to get that care."

Foster's group offers medication abortions for about 500 patients a month. About 90% of their patients are in banned or restrictive states; about a third are from Texas, their most common state of origin, followed by Florida.

"Patients are scared that we are a scam," she says, "they can't believe that we're legit."

Since the WeCount data was collected, additional states including Maine and California have passed shield laws protecting providers who offer care nationwide. The new shield laws circumvent traditional telemedicine laws, which often require out-of-state health providers to be licensed in the states where patients are located. States with abortion bans or restrictions and/or telehealth bans hold the provider at fault, not the patient.

The NPR Politics Podcast

One small pill — one big court case.

Existing lawsuits brought by abortion opponents, including the case awaiting a Supreme Court decision, have the potential to disrupt this telehealth surge by restricting the use of the drug mifepristone nationwide. If the Supreme Court upholds an appeals court ruling, providers would be essentially barred from mailing the drug and an in-person doctor visit would be required.

There is also an effort underway in Louisiana to classify abortion pills as a controlled substance.

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Schumer’s long-awaited AI ‘road map’ is coming this week. It will cost billions.

Crafted by a bipartisan group of senators, the plan reviews a host of issues — including AI’s effect on the military, health care and workers. It could be released as soon as Tuesday.

A bipartisan group of senators, including Majority Leader Charles E. Schumer, will unveil a long-awaited “road map” this week for regulating artificial intelligence, directing Congress to infuse billions of dollars into research and development of the technology while addressing its potential harms.

The sprawling directive comes almost a year after Schumer (D-N.Y.) called for an “all hands on deck” push to regulate AI, saying Congress needed to accomplish years of work in months.

While not legislation, the initiative is intended to provide direction to the Senate committees increasingly crafting bills tackling the technology. The plan reviews a host of issues — including AI’s effect on the military, health care and workers, according to people who have been briefed on the plan, who spoke on the condition of anonymity to discuss the unreleased document. The plan could be made public as soon as Tuesday, one of the people said.

“The road map is still being finalized and should be released shortly,” Schumer spokeswoman Allison Biasotti said in a statement.

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The plan is expected to call for about $32 billion in funding for AI research and development, according to people familiar with it. The figure is based on a 2021 National Security Commission on Artificial Intelligence report, which called for 1 percent of U.S. gross domestic product to be directed to research and development at agencies including the Department of Energy, the National Science Foundation, and the National Institute of Standards and Technology.

The plan will also call for individual sectors — such as health care — to develop specific rules for AI, as well as for the development of testing and transparency measures that will help explain potential harms of the technology. The document will also include provisions to ensure that the U.S. military stays competitive in AI, tracking adversaries’ progress in developing the technology.

The United States lags far behind Europe and other governments in crafting guidelines for AI, and the road map is intended to spur a wave of legislative activity in Congress. The plan has bipartisan backing, but many observers are skeptical that a deeply polarized legislature will be able to craft comprehensive AI laws during a heated presidential election year.

Meanwhile, U.S. tech companies are forging ahead with ever more powerful AI systems and tools. OpenAI on Monday announced a number of upgrades to ChatGPT, powered by a new model that improves the chatbot’s capabilities to listen and respond by voice. Google is expected to announce AI enhancements to its own products at its Tuesday developer conference.

Schumer has urged the United States to swiftly develop guardrails for AI. A bipartisan group of senators dubbed the “AI Gang” — including Sens. Martin Heinrich (D-N.M.), Mike Rounds (R-S.D.) and Todd Young (R-Ind.) — crafted the proposal.

The plan is also expected to call for the passage of bipartisan bills that have already been introduced, including the Create AI Act, which would establish federal infrastructure for AI research, one of the people said. It also includes provisions to promote training and developing workers for other skills, amid broad concerns about the effect artificial intelligence could have on jobs, another of the people said.

Schumer teased the upcoming plan during an interview last week at the AI Expo for National Competitiveness , where he said congressional committees will take the lead on recommendations in the document. Some committees will move faster than others, he said. The Rules Committee, helmed by Sen. Amy Klobuchar (D-Minn.), is scheduled Wednesday to consider three bipartisan bills to address the effect of artificial intelligence on U.S. elections.

“Our committees will go to work,” Schumer said. “Some committees are a little further along than others. We’re not going to wait to have one huge comprehensive plan that touches on everything.”

Schumer’s plan is a product of months of meetings among lawmakers, top tech executives, civil rights and labor leaders, consumer protection advocates, and researchers, through a series of sessions he dubbed “insight forums.” In the most high-profile gathering last year, Schumer held a six-hour session with executives locked in fierce competition to direct the future of AI development, including Tesla CEO Elon Musk, Meta CEO Mark Zuckerberg and OpenAI CEO Sam Altman.

Congresswoman Brown Introduces U-FIGHT Act to Promote Early Detection, Treatment, and Research on Uterine Fibroids

No coordinated HHS grant program exists for fibroids, which can cause severe pain and significant symptoms

Washington, D.C. – Congresswoman Shontel Brown (OH-11) has introduced new legislation to encourage a new federal grant program for the detection and treatment of uterine fibroids, The Uterine Fibroid Intervention and Gynecological Health and Treatment Act (U-FIGHT Act) .

The U-FIGHT Act authorizes the Secretary of Health and Human Services to award grants to increase early detection of and intervention for uterine fibroids, education and awareness programs, and research. The U-FIGHT Act also addresses Asherman’s syndrome, uterine scar tissue build-up following surgery, as well as disparities in pain control and management as it relates to uterine fibroids.

The U-FIGHT Act is co-led by Congresswoman Yvette Clarke (NY-09), who is also the sponsor of the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act , which would support National Institutes of Health research into uterine fibroids. Stephanie Tubbs Jones represented Ohio’s 11 th District from 1999-2008 and first introduced the Uterine Fibroids Research and Education Act in 2001.

Congresswoman Brown’s U-Fight Act has 50 cosponsors in the House of Representatives.

The U-Fight Act is endorsed by: The White Dress Project, The Fibroid Foundation, Black Health Matters, Ohio Physicians for Reproductive Rights, American College of Obstetricians and Gynecologists, Birthing Beautiful Communities , The Center for Black Health & Equity, University Hospitals, Cleveland Clinic, and MetroHealth.

“Uterine fibroids are extremely common, frequently painful, and disproportionally impact Black women – yet there is no comprehensive federal program to address fibroids. That has to change. The U-FIGHT Act encourages early detection, treatment, education and research. For too long women have suffered in silence due to fibroids, I am proud to introduce the U-FIGHT Act so that women can be heard,” said Congresswoman Shontel Brown.  

"For too long, we have witnessed institutional neglect and intentional marginalization make Black women the tragic victims of disparate health outcomes that deliver lasting harms. And uterine fibroids are anything but the exception. It’s past time to invest meaningful resources in the research and resources needed to close these gaps by centering the health of those who have been underserved and overlooked their entire lives. Through increased access and funding for early detection methods, the Uterine Fibroid Intervention and Gynecological Health and Treatment Act represents a meaningful step in our fight to give every Black woman the healthy, happy life she deserves. I’m proud to stand alongside Congresswoman Brown to support this legislative solution that will make a real, tangible difference in the lives of Black women and countless others across the nation,"  said Congresswoman Yvette D. Clarke.

“The White Dress Project's support for the U-FIGHT Act stems from a profound understanding of the struggles faced by women managing life with fibroids and reproductive health challenges. This bill isn't just about legislation; it's a beacon of hope for millions of women, particularly Black women who are disproportionately affected. By spotlighting the urgency of early detection and intervention, the U-FIGHT Act not only enhances the quality of care but also addresses systemic disparities in healthcare. Together, let's champion this vital legislation and empower women to reclaim control over their health and futures,” said Tanika Gray Valbrun, Founder & CEO of The White Dress Project.

“The Fibroid Foundation applauds Rep. Brown for the introduction of the UFIGHT bill. The prevalence of fibroids, as the most frequently diagnosed gynecologic tumor, mandates that we sustain multiple avenues of support, screening, research and funding until we find a cure. Pain and stigma can no longer be the norm. Women and menstruators deserve more,” said Sateria Venable, Founder & CEO of The Fibroid Foundation.

“ Our support in co-sponsoring the Uterine Fibroid Intervention and Gynecological Health and Treatment Act (U-FIGHT) is because here at Black Health Matters™, we know how critical research is needed to understand why fibroids disproportionately affect Black women. We must find methods that improve our quality of care, including earlier detection of fibroids, more effective treatments, and further research on Asherman's syndrome. We deserve good health,” said Corynne Corbett, Editorial Director Black Health Matters.

““Fibroids are unfortunately quite common, particularly in women aged 30 to 40, and may negatively impact quality of life for our patients ,” said Verda J. Hicks, MD, president of the American College of Obstetricians and Gynecologists.  “ACOG is pleased to endorse the U-FIGHT Act with the hope that it will increase access to early screening and detection and allow patients to be offered more tailored, less invasive treatment options. This legislation is especially important and beneficial for Black women who have a 2–3 times higher prevalence of uterine fibroids compared with White women, yet they are often delayed in receiving proper diagnoses and care due in large part to systemic racism. This increased investment in research is sorely needed to better understand the causes, most effective treatments, and the disparities related to fibroids. ACOG thanks Reps. Brown and Clarke for their leadership and for introducing a bill that aims to improve access to, and reduce racial health inequities in, gynecologic care.”  

“We extend our sincere appreciation to Representative Shontel Brown for her leadership in introducing the U-FIGHT Act, a pivotal undertaking in women's healthcare. With millions of Ohioans grappling with uterine fibroids, this legislation signifies a critical expansion of reproductive rights. The disproportionate impact of uterine fibroids on people of color underscores the urgent need for initiatives like the U-FIGHT Act, which aims to address systemic inequities in healthcare access and outcomes. By acknowledging and addressing racial disparities in uterine fibroid prevalence, we can work towards a more just and equitable healthcare system that prioritizes the health and well-being of all individuals, regardless of race or ethnicity," said Dr. Marcela Azevedo, Co-Founder & President Ohio Physicians for Reproductive Rights.

“University Hospitals supports the U-FIGHT Act, which will improve detection and treatment of uterine fibroids, a common condition in women that disproportionately affects African-Americans. This legislation not only supports research to help address healthcare disparities, but promotes access to earlier detection of fibroids and less-invasive treatment options, both of which lead to better outcomes and improved quality of life for patients,” said Stephanie Teal, MD, MPH, Obstetrician and Gynecologist-in-Chief, University Hospitals and Chair, Department of Obstetrics and Gynecology, UH Cleveland Medical Center.

“MetroHealth is committed to breaking down the barriers that prevent far too women in our community from accessing screenings and treatments that can dramatically improve their quality of life. We look forward to working with Congresswoman Brown to advance legislation that would expand access to early screenings and detection methods for uterine fibrosis, a debilitating condition that impacts millions of women, especially women of color. Together, we can create a healthier community for every woman,” said MetroHealth   President & CEO Airica Steed, Ed.D, RN, MBA, FACHE.

“Providing education, research, and access to screening for uterine fibroids is important to improving the quality of care for the millions of women affected by them,” said Beri Ridgeway, M.D., Chief of Staff at Cleveland Clinic. “While not all fibroids require treatment, detection and intervention can reduce symptoms and complications, particularly among women of color, who are impacted by them at a higher rate.”

“At Birthing Beautiful Communities, we are proud to support The U-Fight Act, which would enhance the quality of life for all women diagnosed with uterine fibroids. It is an important step forward in women's health. Unfortunately, many women, particularly Black women, are disproportionately impacted by this condition, and we want to ensure that we have the ability to change that and its impact on our communities," said Jazmin Long, President & CEO, Birthing Beautiful Communities .

"For far too long, the lives of Black women have been disproportionately impacted by uterine fibroids. The burden of medical expenses, missed workdays, and reduced productivity due to symptoms and treatments can exacerbate existing racial disparities. Additionally, the pain, discomfort, and potential complications associated with uterine fibroids hinder the overall well-being and quality of life of Black women, affecting their ability to thrive in various aspects of society. Care providers and policy makers must recognize the unique needs of Black women regarding uterine fibroids and develop tailored strategies to address them. This includes providing access to quality healthcare services, educational and support programs, and research initiatives to better understand the causes and effects of uterine fibroids. In order to ensure that health justice is achieved for Black women, we must take action," said Bronwyn Lucas, MPH Deputy Director of Programs & Services , The Center for Black Health & Equity.

Why the U-Fight Act is Necessary

• Uterine fibroids are extremely common, yet the cause is unknown.  
• There is no current authorization for a HHS grant program for uterine fibroids, limited the federal response to this widespread and significant problem.  
• In addition to uterine fibroids being more prevalent among Black women, the symptoms are also more frequently severe for Black women.
• Uterine fibroids can cause pain, heavy menstrual bleeding, and problems with fertility. Fibroids are the leading cause of hysterectomies in the United States . In rare cases, uterine fibroids require emergency treatment.  
• Early detection and intervention treatment can reduce the need for invasive surgery and treatment options that may impact fertility, including hysterectomy.  
• Early detection can also prevent tumor progression and worsening symptoms (heavy bleeding, cramping, abnormal menstruation).

The U-FIGHT Act

• The U-FIGHT Act authorizes The Secretary of Health and Human Services to:  
• Conduct or support research on the early detection or intervention of uterine fibroids.
• Formulate evidence-based or evidence-informed strategies to increase early detection in health care settings.
• Increase early detection and intervention for uterine fibroids , with funds supporting screening procedures, patient navigation services, program implementation, and patient access to health care settings.  
• Priority shall be given to States proposing to carry out their program in geographic areas with socially vulnerable populations of elevated risk  
• Disparities in pain control and management in uterine fibroid surgical treatment or:  
• Asherman’s Syndrome, intrauterine adhesions, and other intrauterine conditions  
• U-FIGHT requires the submission of a report to Congress and the public detailing findings and developments

Media Contact

Communications Director: Will McDonald Email:    [email protected]  

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Change and Innovation in Healthcare: Findings from Literature

Frida milella.

1 IRCCS Istituto Ortopedico Galeazzi, Milan, Italy

Eliana Alessandra Minelli

2 University Carlo Cattaneo - LIUC, Castellanza, Italy

Fernanda Strozzi

Davide croce.

3 School of Public Health, Faculty of Health Science, Witwatersrand University, Johannesburg, South Africa

4 Centre for Health Economics, Social and Health Care Management, University Carlo Cattaneo - LIUC, Castellanza, Italy

Change is an ongoing process in any organizations. Over years, healthcare organizations have been exposed to multiple external stimuli to change (eg, ageing population, increasing incidence of chronic diseases, ongoing Sars-Cov-2 pandemic) that pointed out the need to convert the current healthcare organizational model. Nowadays, the topic is extremely relevant, rendering organizational change an urgency. The work is structured on a double level of analysis. In the beginning, the paper collects the overall literature on the topic of organisational change in order to identify, on the basis of the citation network, the main existing theoretical approaches. Secondly, the analysis attempts to isolate the scientific production related to the healthcare context, by analysing the body of literature outside the identified citation network, divided by clusters of related studies.

Methodology

This review adopted a quantitative-based method that employs jointly systematic literature review and bibliographic network analysis. Specifically, the study applied a citation network analysis (CNA) and a co-occurrence keywords analysis. The CNA allowed detecting the most relevant papers published over time, identifying the research streams in literature.

The study showed four main findings. Firstly, consistent with past studies, works reviewed pointed out a convergence on the micro-level perspective for change’s analysis. Secondly, an organic viewpoint whereby individual, organization and change’s outcome contribute to any organizational change’s action has been found in its early stage. Thirdly, works reported change combined with innovation’s concept, although the structure of the relationship has not been outlined. Fourth, interestingly, contributions have been limited within the healthcare context.

Human dimension is the primary criticality to be managed to impede failure of the re-organizational path. Individuals are not passive recipients of change: individual change acceptance has been found a key input. Few papers discussed healthcare professionals’ behaviour, and those available focused on technology-led changes perspective. In this view, individual acceptance of change within the healthcare context resulted being undeveloped and offers rooms for further analyses.

Introduction

Healthcare organizations are in an ongoing state of change forcing to convert themselves incrementally or in radical ways. 7 , 65 Organizational change is defined as the ‘change that involves differences in how an organization functions, who its members and leaders are, what form it takes, and how it allocates resources’. 32

Organizational change constitutes a complex phenomenon that develops in any sector. Change in the specific field of healthcare “requires a vision and understanding of the core functions of the system and infrastructure supporting those core functions”. 29

Accordingly, the paper is built upon two sequentially levels of analysis. First, the paper collects the overall scientific production concerning organizational change topic basis on the citations network. This allows for outlining main ongoing theoretical developments and detecting emerging research strands. This preliminary step is critical to gaining an insight into the depth of scientific production in the healthcare context. Second, the work groups additional contributions extant in the literature but not included in the citation network. The analysis is accomplished by selecting papers based on the occurrence of author keywords within the original set of retrieved papers. Thereby, this stage of analysis draws further conclusions on the existing body of knowledge concerning to organizational change in the healthcare context.

Specifically, the paper addresses the following research questions:

 RQ1: What are the current streams of research on change management?

 RQ2: What is the state-of-the-art of change management in the healthcare field?

A quantitative-based method, called “Systematic Literature Network Analysis (SLNA)”, introduced by Colicchia & Strozzi (2012), that employs jointly systematic literature review and bibliographic network analysis is adopted to carry out the two-stage of analysis. The dynamic perspective, which the method provides, eases the detection even of literature gaps not considered to date in the existing body of research production, due to the heterogeneous contributions.

State of Art in Healthcare

Healthcare organizations, described as “professional bureaucracy”, 40 deserve a specific focus.

Consistent with Harney and Monks (2014), 28 hospitals’ organization is characterized by a particular model: the whole arrangement draws upon the power of its high-skilled employees who are in charge to fulfil operational tasks in a professional and specific way. 4 Andreasson et al (2018) 2 observe that, in such a setting, the individuals and teams’ autonomy 53 enables them to operate into an environment where their knowledge and professional skills guide decisions.

Thereby, medical professionals can manage their patients without considering their peers throughout their activities. 24 , 40 This control over their work is partly offset by the so-called collegial influence 13 – based on professional credibility 43 - further considering that physicians pursue professional norms, work standards and institutional scripts provided externally the organization’s structure. 2 Concerning the autonomy of physicians, clinical judgment must be unrestricted due to the complexity of their job and the challenges of measuring outcomes. 33 As a result of this, managers could not handle the medical problem-solving process since they lack knowledge and skillset developed by long periods of training, apprenticeship, and socialization. 33 Such uneven allocation of power – managers – and knowledge – professionals – could determine tension between them. 49

In such perspective, professional bureaucracy organizations fulfil the function of sustaining the necessities of the professionals, who lead “decision-making on a day-to-day basis”, 12 rather than vice versa. 53 More specifically, in hospital environments, administrators are not involved in physicians’ clinical decisions 33 that aim towards patients’ needs. 1 , 36

Enshrined within this approach, it is clear that managers have to negotiate, seeking to be consistent with the organization’s culture, avoiding imposing working programs, procedures and rules. 27 Accordingly, Andreasson et al (2018) 2 observe that independent professionals and strategic leaders have to jointly approve proposed changes.

Hence, professional bureaucracy has developed drawing upon a bottom-up decision-making arrangement. 2 Striving to yield standardized outputs, the inverted power structure, 13 on the one hand, is conceived as rigid, on the other, is resistant towards the change. 40 Therefore, Andreasson et al (2018) 2 consider professional organizations based on professional workers’ authority “rather than on top-down steering”.

Consistent with Mintzberg (1983), 40 managing such an organizational configuration implies facing three distinct managerial issues. Firstly, as aforementioned, discretion might lead the focus away from the patient’s and organizational needs. 33 Secondly, fitting stable environments, professional bureaucracies tend to render “processes as predictable and routine as possible”: 33 thereby there are barriers to innovate in such a context.

Finally, the problem of coordination occurs due to a considerable autonomy that impedes managers to pursue efficiency and effectiveness of care processes’ coordination. 33

To this respect, what should be considered is the role of the professional community in healthcare organizations. The healthcare organizations can be considered as change-resistant due to the greatly fragmented essence of these organizations (namely numerous professional tribes) and the professionals’ power to block change in this sector in so far as not involved in the change process. 19 , 44 Thus, organizations with a high content of professional autonomy require a definition of the problems and actions to implement organizational changes that are not defined exclusively by the highest levels of management.

Health professionals cannot be equated with passive recipients of change because the lack of involvement would lead to considering the suggested solutions “as being poor fit with the local practice at hand”. 18

Materials and Methods

The data used in the paper were collected from Scopus database that provides coverage around 60% larger than the one of Web of Science. 56

At the beginning, related to the topic, the set of chosen keywords does not include specific terms. The multifaceted nature of the investigated subject and the purpose to obtain a comprehensive state of the art suggests performing a search strategy based on two of the most comprehensive author’s keywords, “change management” or “organizational change”.

Based on PRISMA flow diagram, 41 the selection of papers concerned contributions in subject areas ranging from “Business, Management and Accounting” to “Engineering, Social Science and Health Professions” and the search performed in early January 2019, included only articles or conference proceedings published in the last 10 years (2009–2019), with an output of 1968 documents. The query was performed as displayed below in Figure 1 .

Flow chart of the search strategy.

SLNA method contains the analysis of bibliometric networks based on the paper retrieved, such as citations and keywords analysis, as one of its components (Strozzi et al, 2017). In the following, Citation Network Analysis (CNA) and co-occurrence keywords analysis have been detailed.

To build the network two software packages were used: Vos Viewer and Pajek.

Vos Viewer ( http://www.vosviewer.com/ ) is a software tool for creating and displaying bibliometric networks. Vos Viewer was adopted for the preliminary analysis, in terms of network visualization, for creating the input file for Pajek, and for implementing the analysis of the keywords. Pajek ( http://vlado.fmf.uni-lj.si/pub/networks/pajek/ ) is a software tool for network analyses and, in this work, is employed for displaying and discussing the results of a citation network.

Citation Network Analysis (CNA)

CNA is a method based on citations, which are the links between papers (nodes) in a citation network. The isolated nodes cannot be involved in the analysis, and the citation analysis can be performed only when components are connected. 51

The first step in performing network analysis is extracting the isolated nodes, uploaded in VOS Viewer software. The bibliometric network showed only 1284 documents out of 1968 that received at least one citation, displayed in the Pajek tool. Firstly, the bibliometric network was adjusted by changing the direction of knowledge flow (ie, inverting the direction of arrows from cited to citing papers, that is, from the oldest paper to the most recent one). Secondarily, the analysis revealed that only 840 out of 1284 documents were connected.

CNA connected components in this network were 4. The first component included 353 papers, whilst the remaining components were composed of 26, 10 and 4 papers, respectively. Given the small size of the last identified components (ie, 26, 10 and 4) compared with the first one (ie, 353 papers), only the component with 353 nodes was analysed.

Figure 2 shows the first biggest connected component. In order to gain the backbone of the research line related to a group of connected paper, by recognizing the most relevant ones published over time, 11 , 37 , 51 the so-called “main path component” 37 was extracted. The main path enables to detect the main trend in the development of the research line’s contents, by calling attention to the papers based on prior articles which take on the role of hubs to the next ones. 51

First biggest connected component.

The quantification of the transversal weight of the citation was executed. The method “Search Path Count” allows considering all the paths deriving from each source (ie, a paper that does not cite any other) to each sink (ie, a paper not receiving citations by others).

A cut-off value of 0.5 was set (the default value) to eliminate all arcs having a lower value in the original citation network and to obtain the most relevant connected component. Figure 3 depicts the main path for the biggest connected component.

Main path of the first biggest connected component.

To outline a framework as comprehensive as possible on the subject, only the use of citations to trace the coordinates can be limiting. Some papers are not included in the analysis because other ones did not cite them, despite their contents were significant or they may not be selected since they were published recently, therefore they did not still receive a sufficient number of citations. This suggests that the CNA should be combined with other tools such as the Global Citation Score analysis and keyword analysis. 51

In the following, the citation network analysis is designed to trace the active research streams on the topic of organizational change and to have a preliminary assessment of the extent to which these patterns are present even among the studies dealing with organizational change in the healthcare field. In this view, a first-order analysis based on the main path associated with the biggest connected component may be useful to detect general streams and gain an overall picture. The main path sheds light on the articles that refer to prior papers, which act as hubs concerning later works.

Keywords Analysis

Global Citation Network Score Analysis is a tool to detect seminal or recent breakthrough studies 51 that were not selected in the citation network but received a significant amount of citations in the whole Scopus Database. In that sense, these works are however relevant in the field.

Co-occurrence analysis assumes that the authors’ keywords of a paper may be considered a synthetic descriptor of the content but also a reference for detecting linkages among issues analysed. 51 Therefore, the co-occurrence around the same word or pair of words may point out a research subject or trend in a specific field. 14 The tool allows to also consider the papers not having received citations nor citing others, ie, the isolated nodes of connected components. 9 In this work only the author keywords networks 14 will be performed.

Figure 4 shows the co-occurrence network of authors’ keywords obtained from the original database (1968 papers). The network was built by accounting for a minimum threshold of keywords’ occurrence equals 9 (ie, keywords that appear together at least 9 times).

Co-occurrence network of authors’ keywords.

Co-occurrence keywords analysis detects a cluster of contributions previously excluded as not having received citations nor having cited other authors’ papers. Therefore, this stage contributes to a complete preliminary understanding of which literature strands are being developed on organizational change topic within the healthcare field.

The Main Path of the First Biggest Connected Component

The core subject investigated refers to the role of individuals in implementing change, by focusing on the “individual change acceptance”. 67 Several papers 3 , 23 , 25 , 26 , 34 , 35 , 45 , 52 previously published already started adopting “micro-level perspective on change”. 65

A first research stream dwells on the factors enabling individuals to be prepared for specific change initiatives. Normative-reeducative change strategies and work environment steering towards learning culture demonstrate to be facilitators. 65 Readiness for organizational change is accomplished when individual attitude perceives change action as a necessary step and likely to be successful. 65 Therefore, readiness for organizational change is viewed conceptually similar to Lewin’s notion of the unfreezing step. 3 , 16 The group is limited to 5 papers ( Table 1 ).

Summary of Results Obtained by Citation Network Analysis

A second literature flow deepens personal beliefs that individuals develop about change initiatives. Personal appraisals about individual ability to face change actions, ie, “change self-efficacy”, 30 is referred to being factors making individuals more likely willing to accommodate and accept the change. 65 Individual’s pessimistic viewpoint about management ability to be effective in change implementation, ie “cynicism about organizational change”, 55 may jeopardise organizational change accomplishment, 47 as well as the middle managers’ strategy commitment. 63 The group contains 4 papers ( Table 1 ).

The third flow of literature proposes the adoption of a multi-level approach to organizational change and places emphasis on the change outcomes. Merging the individual-focused micro perspective and the organizational-oriented macro perspective, with inflows from meso-level theory 68 may contribute to obtaining a comprehensive vision on organizational change. Change type and change method should be converging to attain the intended change outcome. 58 The group contains 4 papers ( Table 1 .

Consistent with past studies, this step of literature review through CNA shows that works emphasized the need to give emphasis on individual perceptions towards change. The research trajectory appeared to be unexplored in healthcare. Interestingly, a comprehensive framework involving micro-meso and macro perspective to evaluate change actions and the importance of change outcome was found to be emerging trends only in the general literature on organisational change.

The use of keyword analysis is intended to confirm or to extend this initial finding on existing research streams related to the topic of organisational change in healthcare.

Clusters from Keywords Analysis

The first cluster includes approaches to manage change organization within the production context, 91 by illustrating applications in terms of product development 85 and impact on supply chain management. 83 The cluster is composed of 26 papers.

The second cluster reports supportive tools for change management, by emphasizing the importance of formal and informal communication to promote employees’ commitment to change. 75 The cluster is mainly composed of 7 papers.

The third cluster enlarges supportive and boosting tools of organizational change, containing IT applications such as a monitoring system for organizational development activities, 96 team-based simulations improving readiness for change in university setting, 73 and as a means for gaining business-IT alignment. 77 The cluster is mainly composed of 6 papers.

The fourth cluster encompasses the key role of participation for learning within change, 107 even debating a mix of learning styles to sustain successfully organizational change initiative in the healthcare context. 92 The cluster is mainly composed of 5 papers.

The fifth cluster copes with the performance management issue, by soliciting a change in organizational values to enhance a successful performance management reform. 82 Performance issue in the healthcare context is viewed as an outcome after the organizational change process. 76 Change management’s research address the related performance management issue, but the papers reviewed do not offer structured models or approaches. This is consistent with the result debated in the citation network analysis. The cluster is mainly composed of 6 papers.

The sixth cluster focuses on sustainability change initiatives in Higher Education Institutions. 80 Corporate sustainability issue is even addressed to pinpoint the effects of applying sustainability change efforts. 74 The cluster is mainly composed of 8 papers.

The core of the seventh cluster appears to emphasize the dual nature of change, including organizational and technological aspects (eg, 81 , 84 ), and suggests the need for an in-depth analysis on who has the “role of enabler” in change initiatives. This step was already addressed in the citation network analysis, where Choi and Ruona (2011b) 66 quote Rogers (1983) 48 and Rogers (2003) 49 for “the importance of readiness for change through the innovation-decision process model”. The cluster is mainly composed of 9 papers.

Within the eighth cluster, a first subject investigates the factors affecting physicians’ behaviour in technology-driven changes, assuming that clinicians’ beliefs on technology-induced improvements of patients’ care play a critical role. 93 Scholars address the issue in light of the theory of planned behaviour, 93 or by proposing an ad hoc framework where an impact assessment of individual acceptance should be a step before introducing new IoT technology in workflow. Debate on the individual behaviours involved in healthcare organizational changes points out individuals factors such as “personality, social identity and emotional intelligence” 105 influence coping strategies’ choice to tackle change-related stress, as complementary perspective.

A second related subject focuses on the managerial approach to change, revealing that, on one hand, unclear supporting methods by seniors managers may weak middle managers’ change activities, 88 on the other hand, for hospital managers, fully physicians’ involvement in technology-driven changes should impact positively on physicians’ attitude. 93

The relationship between innovation and change in the healthcare context should be explored. Both external and internal factors trigger the need for change in healthcare organizations. For instance, the current epidemiological and demographic transition is provoking a shifting of care’s need towards users affected by chronic diseases. This is leading to a compulsory changing in the healthcare organizational framework. Likewise, the need to make health processes more efficient, for instance, forms another triggering factor, the inside one, for organizational change. Therefore, the organizational change issue should be investigated by bearing in mind these multiple boosts to changing. This supports the need to investigate deeply the concept of change and innovation in a healthcare setting, by seeking to outline the boundaries of organizational change and innovation. In particular, the analysis should start investigating the issue by emphasizing on the fact that micro-context should not be assumed simply as a backcloth to action. 15

The resistance to organizational change initiative arises when professional logic comes into contrast with the management one. 18 In this regard, the future research should investigate the effect of a “local ownership” 18 of the problems behind the change in order to be recognized as relevant critical issues in the organizations by the professionals. Thus, it becomes a priority to seek a new concept of leadership where the recipients of the change can themselves be those who manage the leaders with the possibility to hinder or sustain proactively their leadership. 18 Healthcare organizations are moving towards multifaceted systems. As the work by Augl (2012) 76 pointed out in cluster number 5 of keyword analysis, the health system might be regarded as a set of social systems where organizations may be considered as communication systems. In this regard, the author suggested a new approach to change management by modifying the current communication paths to contextual collaboration. 76 Integrated systems need three pillars as institutional integration (ie, laws), management integration (ie, operational tools) and professional integration (ie, team), which are not mutually exclusive. 6 The cluster includes 31 documents.

Tables 2 and ​ and3 3 display the 8 clusters obtained by VOS (Visualization of Similarities) clustering technique.

Clusters (1-4) Obtained by VOS (Visualization of Similarities) Clustering Technique

Clusters (5-8) Obtained by VOS (Visualization of Similarities) Clustering Technique

Two contexts emerge clearly from the analysis.

The manufacturing context and the healthcare context. The former analyses the issue of organisational change also concerning supply chain management; the latter pays attention to the attitude of the clinician towards change initiatives linked to the introduction of new technology. Of the remaining clusters, some of them relate the topic of change to the adoption of support systems (IT applications – cluster 3) or support strategies (formal and informal communication – cluster 2; participation – cluster 4) for the implementation of change; further clusters tackle the topic of change as a tool to improve performance management (cluster 5) or combine it with sustainable change initiatives and the concept of innovation.

The keyword analysis shows that the general literature streams obtained in the previous CNA analysis are not yet developed in the healthcare context, although interest in the individual’s attitude to change seems to be an emerging approach.

The Importance of Individuals in Organizational Change

With the analysis carried out so far, a growing interest in the most recent literature on the individual-change relationship emerges (ie, 66 ). The subject is developed by scholars from different perspectives. Some authors focus on the psychological mechanisms that induce the individual to change, deepening the individual perception of change both as a skill that the individual recognizes inadequately pursuing a specific change initiative (ie, 30 ), and as the personal belief on the management’s ability to properly implement a change initiative (ie, 66 ). Furthermore, the literature analysed warns that the individual-organizational change relationship is a broad and articulated subject, which cannot be confined to “change recipients” only, but which deserves adequate study also concerning to the “change agents” themselves (ie, 63 ).

The contributions discussed in this paper clearly define the need to deal with acceptance of change from the perspective of the individual. What the general literature on the subject seems to offer, however, is a reading that does not allow linking the individual’s attitude towards change to the specific organizational context in which the change itself will be implemented, especially in the case of complex organizations. Martínez-García and Hernández-Lemus (2013) 38 recognize for example that

health systems are paradigmatic examples of human organizations that merge a multitude of different professional and disciplinary characteristics in a critical performance environment.

The extensive analysis reported on the topic allows contextualizing the organizational change initiatives in the healthcare world, where the individual-change relationship is central and can offer additional ideas on the profile of change recipients.

The research line takes a position on change recipients, by paying attention to the effects that organizational change causes on persons or, in other words, on the psychological aspects of the organizational change. 68 A unified framework of organizational change perspectives (ie, micro, meso and macro), to connect jointly the individual change acceptance to economic and sociological perspectives, 68 is missing, except one work. 68

Change outcome and organizational performance in change initiative appear to be not adequately explored. The work (see 58 ) illustrates only conceptual models. Studies aimed at identifying and testing empirically specific performance measures in the organizational change context appear to be missing.

Moving to the “second-order analysis”, based on co-occurrence keywords analysis, the results confirm and extend the preliminary understanding provided by the citation network analysis. A summary of the results is provided in the table number 4 ( Table 4 ). Cluster 8 provides some insights on the state of art in the healthcare research field. Beyond case studies, the topic becomes relevant only relative to the spreading of digital services in the care system. Other studies (eg, 62 ), retrieved in the previous step, describe a potential stream of organizational change issues in the healthcare context. Notably, these works address change management only concerning the negative health impact for the individual, without paying attention to the individual behaviour change. Moreover, the papers available do not point out change management in the specific context of professionalized organizations. Therefore, studies aimed at investigating the nature of change that characterizes the healthcare professionalized organizations are needed.

Summary of Results Obtained by Co-Occurrence Keywords Analysis

In summary, the literature reviewed informed us that three potential streams were not yet fully explored. Change management in the context of healthcare organizations, performance evaluations and innovation-organizational change relationship was the most evident gaps found out.

Nevertheless, the present work debates individual-level perspective on the change as a prominent dimension to tackle in designing change initiatives, albeit individual and organizational issues related to change should not be viewed as detached. This stimulates to set aside a polarized perspective on organizational change.

The performed review traces a clear step in the production research on the subject. The findings suggest that literature is seeking to overcome a traditional duality approach between “managerial change agent (the good) and resisters to change (the bad)”, 5 , 22 , 56 by paying attention to the critical role of attitude towards organizational change. Especially in the healthcare context, the literature reviewed highlighted an evident imbalance of scientific production in favour of individual effects of changing. This would be consistent with the literature stream identified, which has been moved to an integrated perspective in the organization’s vision during a change management initiative.

Technology and organization appear to be a double face of the change, being strictly related, but there is not a common perspective in defining the role of enabler for those variables. In this respect, further research should address the above-mentioned issue in the organizational change context.

Likewise, a specific investigation on organizational change and the healthcare field is encouraged. Healthcare organizations ought to adopt change models fitting their specific needs of change. Overall literature stream traces a systemic perspective, whereby an individual, organizational and expected outcome of change should be milestones of any organizational change action.

Healthcare organizations receive multiple external and internal stimuli of change.

The increasing dominancy of chronic diseases is forcing to shift the care gravity’s centre on the patient, by modulating the processes of providing the services according to the user and his changing needs. 21 , 31 The availability of new health technologies is changing the way through which health organizations offer services and deliver values (eg, e-health). New technologies are speeding up the demographic changeover and are increasing the economic burden for the NHS. 10 Health organizations are transforming their organizational models, eg, collaborative networks; 8 integrated hospital-local care; 39 , 42 sharing services 17 for reducing administrative costs. 51

The converging outcome lies on strengthen the equity, the value and the sustainability of healthcare.

In this regard, starting from the micro-level analysis, professionals needs’ integration with the organizational design and the individual technology acceptance should be pursued. Exploratory studies may be useful.

Research on change management is gaining momentum and offering many stimuli. Therefore, the development of research lines to deepen the topic is important, especially in the healthcare field.

The authors report no conflicts of interest in this work.