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Current Issues on Research Conducted to Improve Women’s Health

Charalampos siristatidis.

1 Assisted Reproduction Unit, Second Department of Obstetrics and Gynecology, Medical School, National and Kapodistrian University of Athens, Aretaieion Hospital, 76 Vass Sofias, 11528 Athens, Greece

Vasilios Karageorgiou

2 2nd Department of Psychiatry, Medical School, National and Kapodistrian University of Athens, Attikon Hospital, 1 Rimini Street, 12642 Athens, Greece; moc.liamtoh@groegaraksav

Paraskevi Vogiatzi

3 Andromed Health & Reproduction Diagnostic Lab, 3 Mesogion Str, 15126 Maroussi, Greece; moc.liamg@iztaigovive

Associated Data

Not applicable.

There are varied lessons to be learned regarding the current methodological approaches to women’s health research. In the present scheme of growing medical literature and inflation of novel results claiming significance, the sheer amount of information can render evidence-based practice confusing. The factors that classically determined the impact of discoveries appear to be losing ground: citation count and publication rates, hierarchy in author lists according to contribution, and a journal’s impact factor. Through a comprehensive literature search on the currently available data from theses, opinion, and original articles and reviews on this topic, we seek to present to clinicians a narrative synthesis of three crucial axes underlying the totality of the research production chain: (a) critical advances in research methodology, (b) the interplay of academy and industry in a trial conduct, and (c) review- and publication-associated developments. We also provide specific recommendations on the study design and conduct, reviewing the processes and dissemination of data and the conclusions and implementation of findings. Overall, clinicians and the public should be aware of the discourse behind the marketing of alleged breakthrough research. Still, multiple initiatives, such as patient review and strict, supervised literature synthesis, have become more widely accepted. The “bottom-up” approach of a wide dissemination of information to clinicians, together with practical incentives for stakeholders with competing interests to collaborate, promise to improve women’s healthcare.

1. Introduction

Women’s health has been at the center of interest and growing concern in the last few decades. As a measurable outcome, it has been studied at the level of mortality [ 1 ], serious morbidity [ 2 ], and nutritional status [ 3 ] and through proven, evidence-based interventions. The implementation of such interventions is essential to guide national and international policies and programs, targeting the achievement of universal coverage of health services. In this respect, conducting the best quality of research (research that provides firm and ethical evidence adhering to the principles of professionalism, transparency, and auditability) with the use of robust methods is mandatory. Towards this goal, the current reality is far from encouraging.

In accordance with scientific literature guidelines and research quality guidelines (e.g., the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)), impact factors, and citation count are considered the norms in current research evaluation modalities. However, recent works in research methodology challenge this simplifying notion [ 4 , 5 , 6 ].

The pitfalls reported are associated with various—albeit specific—“cultural, ethical, operational, regulatory, and infrastructural factors” linked with a lack of adequately trained researchers and subject attrition bias [ 7 ]. As a result, the clinical research environment is more or less inseminated with various types of bias, leading to the discouragement of sponsors. The growing plethora of questionable quality trials and reviews is another issue to consider. “From 14 reports of trials published per day in 1980 [to] 75 trials and 11 systematic reviews of trials per day, a plateau in growth has not yet been reached”, stated a policy forum article reported in 2010 [ 8 ]; additionally, the authors noted that “the staple of medical literature synthesis remains the non-systematic narrative review”, further pointing out the need for freely available simple yet valid answers to most patients’ questions [ 8 ]. In the same context, current data concerning women’s health derived from protocols, full study reports, and participant-level datasets are rarely available to a wide audience. At the same time, selective reporting of methods and results plagues reports. With the reduced quality of information produced, a lot of money has been wasted; subsequently, the existence of all kinds of bias affect the research itself and jeopardize the validity of the findings and, consequently, the care of women [ 9 ].

Issues have been raised by exploring different approaches to evaluate the quality of scientific input to the community. The ultimate goal remains a robust and uniform literature evaluation system adapted to the evolving conduct of studies and to the application of modern tools to re-ensure robust methodology and reporting of data and results. Here, we perform a narrative overview on current issues in study quality assessment regarding clinical medicine. We electronically searched PubMed using the following keywords: “clinical trials”, “meta-analysis”, “IPD”, “sponsor”, “challenges”, “regulatory”, “women’s health”, “evidence-based medicine/trends”, “policy making”, “publishing”, “research methods and practices”, “consumers network”, “bias”, “industry-sponsored trials”, “biomedical bibliographic databases”, and “quality research”, trying to collect data irrespective of type of report and language. Based on this evidence, we propose a combination of interventions at various levels, underlining quality aspects that we consider significant, and other routes of judgments.

2. The “Standard” Factors

Citation count and publication rates in international databases, hierarchy in author lists according to contribution, and the impact factor of the journal are considered important factors in the quality of a study, especially for the “scientific reader” seeking quality information on a specific topic. This has been extensively studied by other workgroups [ 10 , 11 , 12 , 13 ] and represents a justified trend accounting for the prestige of a scientific journal and the publication itself, along with language and availability, and ultimately skewing scientific trends or potentially leaving some important contributions in obscurity. Even though previous works contemplate the importance of the aforementioned factors in the true quality of research studies and publications, all considerations are derived from a common denominator, that is, that the currently used quality standards either for the common user or for greater structures and institutions most probably do not reflect quality but rather popularity. In this context, the citation rate (including self-citation and “negative citing”) and an impact statement on the individual author (a concise summary of the impact of somebody’s career) have been proposed. In addition, other metrics, including altmetrics, bibliometrics, and H-index, combined with updated mathematical models, such as artificial neural networks, might be the tools of the future; these models constitute more accurate tools due to the special characteristics of these “learning through training” processes, resembling the capacity of the brain to learn and judge [ 14 ].

3. The Type of Research Question and Studies

Although multiple outcomes may be reported at once and variability in study designs fluctuates, a primary role belongs to the type of research question explored by a study or publication, which will inevitably determine the methodology to be followed. For example, in past years, there is a disproportionate output of Systematic Reviews (SRs) and meta-analyses from Asian countries produced on a massive scale [ 15 , 16 ] as a means of “publishing in order to publish” with questionable quality and methods. Their numbers are so high that, in some cases, it overtakes original trials. Of note, the use of such studies in the biomedical field was occasional until the 1990s [ 17 ]. Moreover, those from the Cochrane collaboration, the fundamental organization for good quality systematic reviews, are only a small fraction of this output [ 8 ].

With regard to Randomized Controlled Trials (RCTs), suggestions have been made in recent reports on better conduct [ 18 ]: trial protocols should be simple, reproducible, and well organized, with predefined and well-described study populations/participants and should have sound interventions, and representative comparisons and outcomes. Of note, these could be based on the conclusions of previously conducted SRs that often point out issues in quality and methodology of the original trials. Minimal deviations from protocols and a priori specification of useful core outcomes that translate directly to women’s wellbeing are the focus of the CROWN Initiative [ 19 ]. According to the authors, there has been a multi-targeted set of suggestions to “ensure that critical and important outcomes with good measurement properties are incorporated and reported, in advancing the usefulness of research, in informing readers, including guideline and policy developers, who are involved in decision-making, and in improving evidence-based practice”.

A priori description of the outcomes of interest can alleviate the known issues/biases associated with exploratory analyses. A change in outcome, especially in cases where the results do not support the rationale of the study, can mask the original intentions of the authors and can recontextualize the same results in a more positive manner [ 20 ]. Still, an exploratory analysis has a significant role in deducing potentially valuable conjectures for future studies. However, it is central for transparency that the authors explicitly state when this is the case, i.e., when an analysis is conducted post hoc. In order to ease the distinction of post hoc and a priori analyses by SR authors and readers, Dwan et al. (2014) proposed the publication of both protocols and pre-specified analyses [ 21 ].

We cannot anticipate that SRs can retrospectively solve the potential gaps and inconsistencies in the methodology and outcome reporting. For robust answers, research questions must be well defined from the start. However, more elaborate techniques of evidence synthesis can guide future research in more meaningful ways and are becoming more popular. Specifically, prospective and individual patient data meta-analyses (IPDMA) may need to become the norm in literature synthesis [ 22 , 23 ]. A major difficulty in IPDMA is the fact that securing sensitive patient data is a time-consuming task that demands the establishment of mutual trust. Even when representative evidence has been secured, data availability may still affect the pooled evidence. A recent study assessing IPDMA’s treating oncological topics suggested that studies for which they were available differed significantly from studies in which the authors did not share them [ 24 ]. Still, IPDMA is a trustworthy methodology that can assess the effect of patient-level covariates on treatment outcomes or diagnostic accuracy more thoroughly than the standard procedure of a meta-regression used in aggregate-data meta-analyses [ 25 ]. Given the current ethos of openness in clinical trials and common repositories becoming more widespread, IPDMA is likely to become the mainstay of critical synthesis of literature [ 26 ].

Finally, we have to include observational research in an effort to improve women’s health in the context of greater personalization of care and stratified medicine. Such studies have traditionally served as tools for understanding the nature of particular clinical conditions, for determining risk factors and mechanisms of actions, and for identifying potential intervention targets. Their disadvantages associated with methodological issues such as confounds and the fact that they are prone to limited internal validity could be restricted through guidelines such as the strengthening the reporting of observational studies in epidemiology (STROBE) statement [ 27 ].

4. The Inclusion of Young Authors

The encouragement of younger and/or less experienced scientists and ultimately their inclusion in the respective workgroups and in the list of contributors may provide an unexpected topic or question and a clearer view on established research schemes. The productivity of highly cited papers is related to the advanced age of their authors; adversely, better funding opportunities for younger researchers would give them unique chances to build strong productivity [ 28 ]. The advancement of knowledge taught during academic training as well as a higher probability of compliance with robust methods of reporting should encourage the inclusion of younger scientists. Tips and recommendations of young authors and early career scientists have been plenty, including collaborating with researchers within as well as outside their field and/or country, sending their research article to an appropriate journal, and adequately highlighting the novelty and impact of their research [ 29 , 30 ].

Towards this goal, the improvement of the scientific literacy of young scholars is the main step, and this burden falls on to the shoulders of the trainers. There are “uncomfortable truths” in training [ 31 ], but scientific research and the mode of thinking are processes continuously accumulated and must be taught by each director or responsible authority: they should improve the skills and capabilities of young scholars in scientific and technological literacy and in communication and productivity.

5. Quality in Reporting

Reporting quality must be ensured by avoiding bias, such as selective reporting, deliberate or not. Avoiding reporting insignificant data and outcomes could lead to severe distortion in the SR [ 32 ]. Thus, flaws in design, conduct, analysis, or reporting of RCTs can produce bias in the estimates of a treatment effect.

For example, in a large meta-epidemiological study of 1973 RCTs, a lack of blinding was associated with an average 22% exaggeration of treatment effects among trials that reported subjectively assessed outcomes [ 33 ]. This deviation is enough to adversely affect the interpretation of the results and further negatively influences regulatory settings and clinical practice.

Another example involves the evidence base on recent cancer drug approvals. Between 2014 and 2016, a quarter of the relevant studies were not RCTs; of the RCTs, the majority of them did not measure overall survival or quality of life outcomes as primary endpoints, and half of them were judged to be at high risk of bias; the authors’ judgments changed for a fifth of them when they relied on information reported in regulatory documents and scientific publications separately [ 34 ].

6. Strict Implementation of Rules in the Peer Review Processes

These processes first appeared in 1655 in a collection of scientific essays by Denis de Sallo in the Journal des Scavans , and almost 100 years later (1731), their implementation became a standard of practice by almost all biomedical journals [ 35 ]. Maintaining the quality and scientific integrity of publications; evaluating for competence, significance, and originality; and ensuring internal and external validity of submissions are crucial points. Similarly, the appropriate selection and training of reviewers to provide quality and specialized reviews without bias is an essential part of the process [ 36 ].

7. Sponsorship

Ethical and other issues surrounding sponsorships, to ensure credibility of a study, have been addressed in the past. One of the main sources of funding remains the industry [ 37 ]. Indeed, sponsored clinical research has always been questioned, influenced by reports of selective or biased disclosure of research results, ghostwriting and guest authorship, and inaccurate or incomplete reporting of potential conflicts of interest [ 38 ]. Although these may be a scarce incidence nowadays, active monitoring in funded studies should be implemented throughout in order to eliminate this possibility or any other conflicts of interest. An alarming analysis of 319 trials indicated that only a small minority (three out of 182 funded trials) were funded by multiple sponsors with competing interests. The presence of industry funding also almost tripled (OR = 2.8, 95% CI: 1.6, 4.7) the possibility of a study having reported favorable findings [ 39 ]. Furthermore, registered study protocols that announced funding were less likely to be published after their completion (non-publication rate: 32% vs. 18% [ 40 ].

8. Change in the Notion of Publishing

The change in notion and perception of the impact of outcomes is perhaps the most important part of the improvement in research conduct and implementation. This can be achieved through differentiation and modern adaptation of our scientific culture fighting inner and external incentives. Every scientific input should target a wider human benefit. A change in notion and incentives in publishing is crucial, from the level of the investigator aiming to publish/individual behaviors up to the social forces that provide affordances and incentives for those behaviors [ 41 , 42 , 43 ].

In a specific area of research, a clinical evaluation should precede publication in order to ensure relevance. A dramatic example is the scientific literature demonstrating an overload of various biomarkers for various diseases in which only a few of them have been confirmed by subsequent research and few have entered routine clinical practice [ 44 ]. In addition, biomarkers should also be judged on the grounds of cost-effectiveness and incremental net benefit [ 45 ]. Multiple indices may have comparable diagnostic accuracy, but their cost, an unavoidable concern in public health, may differ significantly.

Therefore, the selection of information to be published should be conducted on safer grounds and should be adequately supported by the authors, based on our knowledge on the scheme to date, and importantly, a summary of previous attempts should note the effective interventions and provide a concluding remark for the scientist through a good quality review.

9. Patient’s Contribution to Evaluation and Sex/Gender Analyses

In the era of evidence-based medicine, feedback from the recipients of healthcare development is gaining more importance and platforms for opinion exchange between patients and investigators have been established. This has already been implemented by the Cochrane Collaboration, where patient review is an integral part of the SR publication process and plain language summaries target a nontechnical audience. This process could be adopted as standard practice if accordingly modified. If the patient review, for example, is to be widely implemented in other journals, it would constitute a potentially radical paradigm shift that aims to solidify the review process. Of course, technical difficulties, such as acknowledgement and incentives for patients participating in review processes, are fields where further developments will enhance this policy [ 46 ].

It has been noted that the women population represents an “unequal majority” in health and health care. It is also well established that women’s health needs are dissimilar from those of men, resulting from the fact that both the woman’s body and brain functions differ critically from a man’s and that she reacts differently to even the same stimuli, such as medications or environmental events. It is indicative that, even though a large proportion of study protocols included women, only 3% of them planned an analytical approach for quantifying sex differences [ 47 ]; similarly, a recent report on therapies for atrial fibrillation concluded that the sex-specific reporting in trials comparing them was extremely low [ 48 ]. As a result, women have not received an ideal “personalized” health care, in many cases, so far. Thus, a specific design for studies on women’s health should be required.

There are several examples in the history of women’s health research where the contribution of the consumer women’s health movement in promoting research in women’s interests was critical. One of them concerned the collaborations between consumer groups and researchers in obtaining funding in the U.S. and France for a follow-up on a cohort of diethylstilboestrol-exposed people when the drug was discovered to be a transplacental carcinogen in pregnancy in 1971.

Another important issue is the nonavailability of sex/gender data from primary studies and consequently from SRs, which are the main tools to provide the necessary evidence for the formation of relevant policies [ 49 ]: the authors stated that even “Cochrane and the Campbell Collaboration have no specific policy on the reporting of sex/gender in systematic reviews, although Cochrane has endorsed the SAGER guidelines developed by the European Association of Science Editors” [ 50 ]. In their review, they found that the Methods sections of these collaborations included the most reports on sex/gender in both Campbell (50.8%) and Cochrane (83.1%) reviews, but the majority of these were descriptive considerations of sex/gender. They also reported that 62% of Campbell and 86% of Cochrane reviews did not report sex/gender in the abstract but included sex/gender considerations in a later section. A previous study on the subject reported that almost half of SRs described the sex/gender of the included populations but only 4% assessed sex/gender differences or included sex/gender when making judgments on the implications of the evidence [ 51 ].

10. An Improvement in the Dissemination of Studies

Despite advances in the dissemination of study information, half of health-related studies remain unpublished [ 52 ]. Problems in the publishing scheme in the selection of studies that appear to have a higher impact or that come from a respectable institution can lead to biased publishing. At the extreme, unsafe, ineffective, or even harmful interventions may enter clinical practice, as was the case with hormone replacement therapy [ 53 ]. In some instances, even a shift in healthcare resource allocation is reported [ 9 ]. It is standard practice in critical readings of literature to evaluate publication bias. This method attempts to address, with controversial success, precisely the unfortunate keenness of editors to promote positive results that imply novelty. A classic example of this inflation of positive and supposedly important results is the 2012 study by Fanelli [ 54 ], in which studies classified as related to clinical medicine showed a gradual increase in reporting positive findings. The author criticized the efficacy of measures taken to attenuate publication bias, e.g., protocol registration.

On the other hand, a respectable amount of research is published in other languages and not indexed in U.S. National Library of Medicine [ 55 ], while their quality remains controversial [ 56 ]; the authors of the above studies stated that peer review processes need to be improved through guidelines aiming to identify the authenticity of the studies.

The bulk of peer reviews remain a voluntary occupation, with the main motivation being recognition by peers. In addition, statistical review, a time-consuming process, is not performed in all published research. This process can be accelerated by practices that promote data and code sharing. It is also suggested that, even when papers are retracted, this could have been avoided with the simple measure of an active data sharing policy [ 57 ].

11. Role of the Stakeholders and Foundations

For the stakeholders and collaborative systems, a more energetic role is required in ensuring the conduct of multicenter massive-trials with increased clinical relevance. The main problem in the conduct of research is the lowered clinical value of the results from small sample sizes, even in RCTs. Mathematical models have been developed to predict sample sizes corresponding to the clinical value of the outcomes, while patient data from databases could easily increase the sample size of trials at much lower costs. Such paradigms could include the Health Care Systems Research Collaboratory and the Patient-Centered Outcomes Research Network (PCORnet) [ 58 ]. Also, new levels of patient engagement can raise the possibility of improving clinical outcomes on health. Involving multiple stakeholders (with potentially conflicting interests) in shared conversations on research has been proposed [ 59 ].

New foundations should be placed in research by focusing on the improvement of quality, such as NIH and PCORI [ 60 ]. The Cochrane Collaboration represents one of the very few large-scale initiatives in this context; importantly, both conduct high quality reviews, and participant education at all levels are based mostly from volunteers who care about science and high-quality evidence.

12. Cooperation of All Forces: The Role of Industry/Funding

The central point of problem is funding. USA-affiliated industry-funded trials and related activities represent more than 5% of US healthcare expenditure, with approximately $70 billion in commercial and $40 billion in governmental and non-profit funding annually. The NIH invests $41.7 billion annually in medical research: 80 percent is awarded for extramural research, through 50,000 competitive grants to more than 300,000 researchers at more than 2500 universities, medical schools, and other research institutions [ 61 ]. Concerns have been raised that this approach appears inefficient for how biomedical research is chosen, designed, regulated, financed, managed, disseminated, and reported [ 62 , 63 , 64 ].

The scheme, however, has been shifting in favor of Asian countries. Factors, such as ease of recruitment, population, and various epidemiological factors (e.g., increased incidence of infectious disease) have contributed positively to an inflation of local clinical trials [ 7 ]. Severe accusations regarding clinical data management have been raised, although the magnitude of the problem cannot be safely evaluated [ 65 ]. This unavoidably hinders the validity and future usefulness of these results despite initial enthusiasm from editors and the industry.

Economic forces are important, and ultimately, the industry seeks to maximize profit by providing new products and services to the medical market [ 66 ]. In industry-funded clinical research, intentional and unintentional commercial motives can control the study design and comparators. Governmental involvement [ 66 ] has an important role in distributing research funds in areas important for the protection and restoration of human health, even when the prospects for commercial profit are poor or nonexistent. The recruitment of specialized and qualified professionals should set higher standards of rigor when they are involved in commercial or unavoidably conflicted relationships and to disseminate the resources evenly, especially when nowadays these are scarce.

Funders and academic institutions are responsible for the moral status, as research usually initiates from there and determines any kind of shift in the process. Academics might be judged on the methodological rigor and full dissemination of their research, the quality of their reports, and the reproducibility of their findings. Previous reports suggest ways to increase the relevance and to optimize resource allocation in biomedical research, indicating how resource allocation should be conducted, along with revisions in the appropriateness of research design, methods, and analysis, with efficient research regulation and management fully accessible information, promoting unbiased and usable reports. Additionally, motivation must be given to authors to share their data [ 67 ], as has been performed in the field of genetics [ 68 ]. Of note, synthesis of evidence on the meta-epidemiological level cannot always confidently provide answers to practical clinical questions [ 69 ].

Compromised ethics should be traced and removed from independent research and academia, while journals should on no occasion put profit and publicity above quality. The solution to this lies on the progressive refinement of methods and improvement of the objective and controlled processes.

13. Training

Essential training and interprofessional learning of clinicians and other hands-on scientists in the medical field are an absolute must. There is a growing need to improve their scientific insight and judgment. Reviewers should learn how to apply an unbiased critical thinking and evaluation of the methods explored, of the study questions, and of the resulting impact towards good clinical practice and human welfare. This not only applies to organizational refinement by the Academic Institutes and Publishing Organizations but also to the scientists themselves to obtain the drive to train, along with methodologists and statisticians, so that specialization and knowledge is shared and every contributor works soundly towards a common cause.

14. Conclusions

Research is a solid foundation for the progression of sciences, and the key importance in maintaining the evolution of knowledge is “contributing and sharing”, but this has to be performed adequately. Although there are several criteria and controlled circumstances under which new data and overviews of data are published, research and publishing methods require continuous readjustments and modifications to ensure quality. An overview of the published literature on women’s health and its relevant subtopics is an excellent paradigm on a crucial field of the different types of research and publications that one may encounter but also an example of the vast variability in information available, not only in terms of results but also in terms of design, analysis, quality of information, and implementation of results. In clinical practice, it is imperative to assess information collectively a researcher, medical expert, funder, reviewer, and patient, and this should encourage the improvement of evidence-based patient management.

This review aimed to present the major nodal points of quality and to propose a combination of interventions at various levels, along with other routes of judgement. We also sought to address potential flaws and pitfalls in research conduct and to provide recommendations upon improvement of study designs/methods and scientific reporting to promote publication quality and stricter criteria for release with support from the appropriate structures. A summary of recommendations towards evidence implementation as presented in Table 1 could comprise valuable guidance to both the health experts and the health service recipients to which these standards are quality criteria. A meticulous study design that promotes the transparency of methods and potential conflicts allows a clear distinction of the pathologies and targeted groups and that provides substantial scientific background should be pursued by both researchers and readers. Robust implementation of the pre-stated methods and approaches of analysis, with active participation of collective fronts tied to the subject, should allow quality output to be published and should add value to the findings. Patient-first and common welfare should be considered throughout in conjunction with supporting and providing evidence on robust outcomes for the improvement of healthcare, that may be facilitated by healthy and network collaborations.

Summary of the recommendations for the steps towards evidence implementation.

How these recommendations should be accounted for, evaluated, and implemented relies on the individual discretion of the reader, the scientist, the author, or any entity affiliated with a publishing organization and should be customized to be applied individually for each specialized academic and scientific field but also tailored across continents and countries. The latter is derived from the realization that research conduct, funding, and even the monitoring authorities of clinical studies rely on nonuniform procedures among countries and unions and conforms to different legal frameworks across countries. Nevertheless, a core of actions, precautions, and a quality exemplar of golden standards should be constructed and widely applied to meet the standards that describe a representative scientific contribution, for example, uniform, widely accepted, and practiced standards through policies, guidelines, and rules on a national and/or international level created either by in-country legislation or by scientific entities; allocation of the resources for their implementation; and mechanisms of control for their application and adherence by all.

In conclusion, multiple steps throughout the long and costly process of trial conduct are prone to bias. Notably, increasing international competition favors faster and cheaper patient recruitment, conduct, and analysis and, in turn, produces questionable research. Literature synthesis through SRs and/or meta-analysis has a primarily retrospective role that guides future research and sheds light on arguable topics but cannot erase the wrongdoings of primary studies, which are often concealed. The “bottom-up” approach of a wide dissemination of information to clinicians, together with practical incentives for stakeholders with competing interests to collaborate, promise to improve women’s healthcare.

Author Contributions

C.S. conceived and designed the study and prepared the manuscript. P.V. and V.K. contributed to the design and reporting of the research. All authors approved the final version of the manuscript.

This research received no external funding. The APC was funded by the first author.

Informed Consent Statement

Not applicable due to the nature of this study.

Data Availability Statement

Conflicts of interest.

The authors have no conflicts of interest.

Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Home » Blog » The Evolution of Women’s Health Research  

The Evolution of Women’s Health Research  

Our current understanding of women’s health research—the study of health across a woman’s lifespan in order to preserve wellness and to prevent, diagnose, and treat disease, for the full range of health conditions for which women are disproportionately or differently affected by—did not exist until about 30 years ago.   

Where Women’s Health Research Started    

Up until the 1990s, essentially all health research was conducted exclusively or predominantly on men and by men .   

For decades, women were actively excluded from participating in most clinical trials because of the belief that female hormonal cycles were too difficult to manage in experiments and a fear that the inclusion of women in trials may harm women’s reproductive health , including potential pregnancies. Additionally, the assumption that using only one sex would reduce variation in trial results meant that research also did not incorporate female animals, cells, and tissue. Researchers, therefore, often assumed that results from all-male studies could be extrapolated to females—compromising women’s health care.   

The Society for Women’s Health Research (SWHR) was founded in 1990 by Dr. Florence Haseltine to correct this balance and bring attention to the space of women’s health research. Soon after its founding, SWHR joined other advocacy groups to encourage Congress to pass the National Institutes of Health (NIH) Revitalization Act of 1993 , mandating the inclusion of women and minorities in NIH-funded clinical trials. In the same year, the Food and Drug Administration (FDA) required the inclusion of women in efficacy studies and in the analysis of data on sex differences. Two decades later, in 2016, the NIH implemented a policy stating that sex as a biological variable should be factored into preclinical research and study reporting. Today, all NIH-funded researchers must either include both female and male research subjects or explain why they do not.   

Continuing to Close the Gaps   

Throughout the years, SWHR has actively educated on and promoted the growth of women’s health research. SWHR helped found the Organization for the Study of Sex Differences (OSSD) in 2006 and launch the Biology of Sex Differences journal in 2010. With each new program, SWHR is helping close gaps by promoting research on biological sex differences in disease and improving women’s health through science, policy, and education:   

• SWHR regularly convenes interdisciplinary stakeholders to discuss women’s health topics and identify research gaps and unmet needs for women’s health across the lifespan. For example, SWHR is hosting “ The Impact of Narcolepsy on Women’s Health Across the Lifespan”, a closed roundtable on March 31, 2022 with experts in psychiatry, sleep, pediatrics, and more, to better understand sleep conditions in women. SWHR will publish conversation insights on its blog in early April.   
• SWHR continues to act as a resource for policymakers and pushes for the improved inclusion and representation of women from diverse backgrounds across all levels of science. SWHR continually responds to policy initiatives concerning women’s health, such as providing comments on the recent draft NIH Chief Officer for Scientific Workforce Diversity Strategic Plan and supporting the creation, work, and implementation of recommendations of the Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC).    
• SWHR serves as a trusted source for women’s health information and raises awareness about women’s health issues for women, their families, and their providers, particularly through the creation of resources, such as fact sheets, policy roadmaps, and patient toolkits. SWHR’s recent resources range from a Genetic Screening Poster made for use in health offices to a Migraine Matters Fact Sheet to help people living with migraine, 3 in 4 of whom are women.   

Women’s Health Research in 2022   

While SWHR has been excited to witness and support the expansion of women’s health research to new heights, much remains to be done to close knowledge and care gaps. As we celebrate International Women’s Day, SWHR remains invigorated about the task of advancing women’s health research and the prospect of improved care for women everywhere.   

Recent improvements in women’s health provide encouragement for the future: expanded COVID-19 vaccine research on pregnant women, from the Centers for Disease Control and Prevention (CDC) has shown the vaccine to be safe for mothers and infants when administered during pregnancy; the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act has been introduced in Congress and, if passed, will advance research and care for uterine fibroids; and the Protecting Moms Who Served Act , the first bill of the Black Maternal Health Momnibus to be enacted, was signed into law in November 2021, taking us one step closer to ending maternal mortality in the United States and closing disparities in maternal health outcomes.  

This year’s International Women’s Day theme of # BreakTheBias reminds us that in working together we can eliminate bias, whether it is across the scientific workforce, in funding research awards, in health care innovation, or within scientific research and clinical trials. Together, we can achieve women’s equality and advance women’s health research for decades to come.   

Join SWHR in helping make women’s health mainstream. Learn more about the history of women’s health research here and SWHR’s role in it here .   

This article was also reposted on SWHR’s LinkedIn account.

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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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Study of data from thousands of women suggests ovarian cycle is regulated by circadian rhythm

by Bob Yirka , Medical Xpress

A team of reproductive researchers affiliated with several institutions in France and the U.S. has found that the timing of monthly ovarian cycles in women is mostly likely attributable to the circadian rhythm. In their paper published in the journal Science Advances , the group describes their study of thousands of ovarian cycles as reported by thousands of women in Europe and the U.S. and what they found.

The timing mechanism behind the ovarian cycle has mystified scientists for centuries, though one of the strongest theories has been that it is tied to the lunar cycle . Charles Darwin suggested that the two became linked back when humans lived near the seashore, where the tides heavily impacted daily scheduling.

And three years ago a team led by Würzburg chronobiologist Charlotte Förster found evidence for women's menstrual cycles temporarily synchronizing with the cycles of the moon . In this new effort, the research team has found little evidence of a lunar impact—they suggest the mechanism most likely controlling the ovarian cycle is the circadian rhythm.

The circadian rhythm is defined as physical, mental, and behavioral changes that organisms, such as humans, experience over 24-hour cycles. One of the most famous behaviors impacted by the circadian rhythm is sleep—people tend to feel sleepy at the same time every night. However, it has also been noted that the circadian rhythm can be impacted by the lunar cycle—people have been found to go to bed later and sleep less, for example, on nights before a full moon .

To learn more about the ovarian cycle-controlling mechanism, the research team obtained medical records for over 3,000 women living in Europe and North America, which held data relating to 27,000 ovarian cycles. The team tracked the first day of each cycle for all the women under study. In doing so, they found little correlation between cycle start time and lunar cycling.

The researchers did find something else, though. Many examples of what they describe as phase jumps—where something disturbs the timing of a cycle for a given woman, and the body responds by changing the clock rhythm over several months to bring the cycle back to its original norm. They compare it to how the circadian rhythm reacts to people experiencing jet lag. This, they suggest, indicates that the circadian rhythm is much more likely the mechanism that controls ovarian cycling.

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AI model can accurately assess PTSD in postpartum women

Early intervention is critical to prevent progression of a disorder which may carry serious health consequences for as many as eight million women a year globally.

A generative artificial intelligence (AI) model that can analyze the narrative accounts of women who have undergone recent childbirth has shown the ability to accurately screen for post-traumatic stress disorder (CB-PTSD), a study by Massachusetts General Hospital (MGH), a founding member of the Mass General Brigham healthcare system has found.

By exploring the capabilities and shortcomings of several models from OpenAI, including ChatGPT, the researchers identified a version that offers rich insights into maternal mental health following traumatic childbirth.

The model can fit seamlessly into routine obstetric care and could potentially be harnessed to assess other mental health disorders. The results of the study were published in Scientific Reports .

"Evaluation of PTSD related to traumatic birth currently relies on extensive clinician evaluation, which fails to meet the urgent need for a rapid, low-cost assessment strategy," says Sharon Dekel, PhD, director of MGH's Postpartum Traumatic Stress Disorders Research Program, and senior author of the study.

"The use of brief patient narratives of childbirth analyzed by AI's text-based computational methods could become an efficient, low-cost, and patient-friendly strategy for detecting CB-PTSD after a traumatic birth and with more research this tool may potentially aid in identifying women at risk for CB-PTSD before the condition fully develops."

For an estimated eight million women a year globally, childbirth that is traumatic and/or medically complicated is expected to trigger post-traumatic stress disorder, a condition historically has been associated with military combat or severe sexual assault.

In recent years, childbirth has become acknowledged as a significant PTSD trigger which, if left untreated, can impair the health of both the mother and child and result in significant societal costs.

In previous studies, Dekel's lab found evidence that brief psychological interventions delivered soon after traumatic childbirth can reduce maternal childbirth-related PTSD symptoms.

In their latest study, Dekel in collaboration with first author Alon Bartal, PhD, of Bar-Ilan University in Israel, investigated the effectiveness of artificial intelligence and related machine learning (ML) analysis strategies to detect CB-PTSD.

Specifically, they evaluated the performance of different large language models (LLMs) and variations of ChatGPT and their ability to extract novel insights from text-based data sets derived from the brief narrative descriptions by postpartum women of their childbirth experience.

As part of their work, the team collected short narrative accounts from 1,295 women who had recently given birth.

The study focused on an OpenAI model known as text-embeddings-ada-002, which converted narrative data from the personal accounts of women with and without probable CB-PTSD to a numerical format that was then analyzed by a trained machine learning algorithm developed by the team.

Researchers showed this model had superior performance in identifying postpartum traumatic stress compared to other ChatGPT and large language models, which are typically trained on huge volumes of data allowing them to understand, analyze and interpret natural language.

"The reliance of the ML model using childbirth narrative input from the Open AI model as its exclusive data source presents an efficient mechanism for data collection during the vulnerable postpartum period, demonstrating 85 percent sensitivity and 75 percent specificity in identifying CB-PTSD cases," notes Dekel.

"Moreover, the model we developed could potentially improve accessibility to CB-PTSD screening and diagnosis by fitting seamlessly into routine obstetric care and providing a foundation for commercial product development and mainstream adoption."

Dekel, whose research program is dedicated to exploring women's mental health following traumatic childbirth, underscores the clinical benefits of using a pre-trained large language model to assess potential PTSD in new mothers.

"Early intervention is essential to prevent the progression of this disorder to chronic stages, which can seriously complicate treatment," the MGH investigator points out.

"Our unique approach could introduce an innovative and cost-effective screening strategy for identifying high-risk women and facilitating timely treatment. It may also holds promise for assessing other mental health disorders, and consequently improving patient outcomes."

The emergence of artificial intelligence tools in health has been groundbreaking and has the potential to positively reshape the continuum of care. Mass General Brigham, as one of the nation's top integrated academic health systems and largest innovation enterprises, is leading the way in conducting rigorous research on new and emerging technologies to inform the responsible incorporation of AI into care delivery, workforce support, and administrative processes.?

Dekel is a psychologist at MGH, and assistant professor of Psychology at Harvard Medical School. Bartal is an assistant professor of Information Systems at Bar-Ilan University in Israel. Co-authors in the Dekel Laboratory include Kathleen Jagodnik, PhD, a Harvard research fellow, and Sabrina Chan, a clinical research coordinator.

Dekel was supported by funds from the NIH (Eunice Kennedy Shriver National Institute of Child Health and Human Development, grants R01HD108619, R21HD109546, and R21HD100817).

• Mental Health Research
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• Post-traumatic stress disorder
• Urinary incontinence
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• Maternal bond

Story Source:

Materials provided by Massachusetts General Hospital . Note: Content may be edited for style and length.

Journal Reference :

• Alon Bartal, Kathleen M. Jagodnik, Sabrina J. Chan, Sharon Dekel. AI and narrative embeddings detect PTSD following childbirth via birth stories . Scientific Reports , 2024; 14 (1) DOI: 10.1038/s41598-024-54242-2

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• April 13, 2024 | New Research Indicates That Loneliness Triggers Sugar Cravings in Women
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New Research Indicates That Loneliness Triggers Sugar Cravings in Women

By University of California - Los Angeles Health Sciences April 13, 2024

A UCLA Health study has discovered that lonely women are more inclined to crave high-calorie, sugary foods, demonstrating a link between loneliness, unhealthy eating behaviors, and poor mental health. The research highlights the brain’s role in these correlations and suggests holistic interventions as potential remedies to break the cycle of loneliness and unhealthy eating.

Research indicates that lonely women show heightened brain activity in areas linked to cravings for food.

A recent study by UCLA Health discovered that women who feel lonely show brain activity in areas linked to cravings and the drive to eat, particularly when viewing images of high-calorie foods like sugary treats. These women also displayed unhealthy eating habits and suffered from poor mental health.

Arpana Gupta, Ph.D., a researcher and co-director of the UCLA Goodman-Luskin Microbiome Center, wanted to research the negative impacts of loneliness, especially as people continue to be working remotely after the COVID-19 pandemic, and how the brain interplays with social isolation, eating habits, and mental health. While it is established that obesity is linked to depression and anxiety and that binge eating is understood to be a coping mechanism against loneliness, Gupta wanted to observe the brain pathways associated with these feelings and behaviors.

“Researching how the brain processes loneliness and how this is related to obesity and health outcomes hasn’t been done,” said Gupta, senior author of the paper, which is published in JAMA Network Open .

Methodology and Findings

The researchers surveyed 93 women about their support system and their feelings of loneliness and isolation, then separated them into two groups: those who scored high on the perceived social isolation scale, and those who scored low. The researchers found that women who had higher levels of social isolation tended to have higher fat mass, lower diet quality, greater cravings, reward-based eating, and uncontrolled eating, and increased levels of anxiety and depression.

The women were then shown pictures of food versus non-food, sweet food versus non-food, and savory food versus non-food. MRI scans recorded the participants’ brain activity while they viewed these images.

The researchers found that the group of women who perceived themselves to be lonely experienced increased activation in regions of the brain associated with greater cravings to eat sugary foods, and decreased activation in the brain region associated with self-control toward eating behaviors.

Conclusions and Implications

“These findings are interesting because it provides evidence for what we intuitively know,” Gupta said. “When people are alone or lonely, it impacts more than how they are feeling; they underreport what they eat, their desire to eat, and their cravings especially for unhealthy foods.”

“If you have more cravings, you eat more and may have more anxiety or depression, which may lead you to eat more,” Xiaobei Zhang, postdoctoral researcher and lead author stated, likening this pathway to a “vicious cycle between unhealthy eating and negative mental symptoms.”

The researchers said holistic mind-body interventions may be a solution for breaking out of the cycle. Examples include being aware that you are lonely and, depending on the person, seek connection with others or practice self-compassion. Another suggestion is to make healthier food choices. “Instead of grabbing that highly addictive, sweet, high-calorie food that you’re craving, maybe trying to go for healthy foods versus those bad foods,” Gupta said.

Gupta’s future research will focus on looking at other biological markers such as the metabolites, microbiome, and inflammatory signatures associated with loneliness.

Reference: “Social Isolation, Brain Food Cue Processing, Eating Behaviors, and Mental Health Symptoms” by Xiaobei Zhang, Soumya Ravichandran, Gilbert C. Gee, Tien S. Dong, Hiram Beltrán-Sánchez, May C. Wang, Lisa A. Kilpatrick, Jennifer S. Labus, Allison Vaughan and Arpana Gupta, 4 April 2024, JAMA Network Open . DOI: 10.1001/jamanetworkopen.2024.4855

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Two key brain systems are central to psychosis, Stanford Medicine-led study finds

When the brain has trouble filtering incoming information and predicting what’s likely to happen, psychosis can result, Stanford Medicine-led research shows.

April 11, 2024 - By Erin Digitale

People with psychosis have trouble filtering relevant information (mesh funnel) and predicting rewarding events (broken crystal ball), creating a complex inner world. Emily Moskal

Inside the brains of people with psychosis, two key systems are malfunctioning: a “filter” that directs attention toward important external events and internal thoughts, and a “predictor” composed of pathways that anticipate rewards.

Dysfunction of these systems makes it difficult to know what’s real, manifesting as hallucinations and delusions. 

The findings come from a Stanford Medicine-led study , published April 11 in  Molecular Psychiatry , that used brain scan data from children, teens and young adults with psychosis. The results confirm an existing theory of how breaks with reality occur.

“This work provides a good model for understanding the development and progression of schizophrenia, which is a challenging problem,” said lead author  Kaustubh Supekar , PhD, clinical associate professor of psychiatry and behavioral sciences.

The findings, observed in individuals with a rare genetic disease called 22q11.2 deletion syndrome who experience psychosis as well as in those with psychosis of unknown origin, advance scientists’ understanding of the underlying brain mechanisms and theoretical frameworks related to psychosis.

During psychosis, patients experience hallucinations, such as hearing voices, and hold delusional beliefs, such as thinking that people who are not real exist. Psychosis can occur on its own and isa hallmark of certain serious mental illnesses, including bipolar disorder and schizophrenia. Schizophrenia is also characterized by social withdrawal, disorganized thinking and speech, and a reduction in energy and motivation.

It is challenging to study how schizophrenia begins in the brain. The condition usually emerges in teens or young adults, most of whom soon begin taking antipsychotic medications to ease their symptoms. When researchers analyze brain scans from people with established schizophrenia, they cannot distinguish the effects of the disease from the effects of the medications. They also do not know how schizophrenia changes the brain as the disease progresses. 

To get an early view of the disease process, the Stanford Medicine team studied young people aged 6 to 39 with 22q11.2 deletion syndrome, a genetic condition with a 30% risk for psychosis, schizophrenia or both. 

Kaustubh Supekar

Brain function in 22q11.2 patients who have psychosis is similar to that in people with psychosis of unknown origin, they found. And these brain patterns matched what the researchers had previously theorized was generating psychosis symptoms.

“The brain patterns we identified support our theoretical models of how cognitive control systems malfunction in psychosis,” said senior study author  Vinod Menon , PhD, the Rachael L. and Walter F. Nichols, MD, Professor; a professor of psychiatry and behavioral sciences; and director of the  Stanford Cognitive and Systems Neuroscience Laboratory .

Thoughts that are not linked to reality can capture the brain’s cognitive control networks, he said. “This process derails the normal functioning of cognitive control, allowing intrusive thoughts to dominate, culminating in symptoms we recognize as psychosis.”

Cerebral sorting  

Normally, the brain’s cognitive filtering system — aka the salience network — works behind the scenes to selectively direct our attention to important internal thoughts and external events. With its help, we can dismiss irrational thoughts and unimportant events and focus on what’s real and meaningful to us, such as paying attention to traffic so we avoid a collision.

The ventral striatum, a small brain region, and associated brain pathways driven by dopamine, play an important role in predicting what will be rewarding or important. 

For the study, the researchers assembled as much functional MRI brain-scan data as possible from young people with 22q11.2 deletion syndrome, totaling 101 individuals scanned at three different universities. (The study also included brain scans from several comparison groups without 22q11.2 deletion syndrome: 120 people with early idiopathic psychosis, 101 people with autism, 123 with attention deficit/hyperactivity disorder and 411 healthy controls.) 

The genetic condition, characterized by deletion of part of the 22nd chromosome, affects 1 in every 2,000 to 4,000 people. In addition to the 30% risk of schizophrenia or psychosis, people with the syndrome can also have autism or attention deficit hyperactivity disorder, which is why these conditions were included in the comparison groups.

The researchers used a type of machine learning algorithm called a spatiotemporal deep neural network to characterize patterns of brain function in all patients with 22q11.2 deletion syndrome compared with healthy subjects. With a cohort of patients whose brains were scanned at the University of California, Los Angeles, they developed an algorithmic model that distinguished brain scans from people with 22q11.2 deletion syndrome versus those without it. The model predicted the syndrome with greater than 94% accuracy. They validated the model in additional groups of people with or without the genetic syndrome who had received brain scans at UC Davis and Pontificia Universidad Católica de Chile, showing that in these independent groups, the model sorted brain scans with 84% to 90% accuracy.

The researchers then used the model to investigate which brain features play the biggest role in psychosis. Prior studies of psychosis had not given consistent results, likely because their sample sizes were too small. 

Vinod Menon

Comparing brain scans from 22q11.2 deletion syndrome patients who had and did not have psychosis, the researchers showed that the brain areas contributing most to psychosis are the anterior insula (a key part of the salience network or “filter”) and the ventral striatum (the “reward predictor”); this was true for different cohorts of patients.

In comparing the brain features of people with 22q11.2 deletion syndrome and psychosis against people with psychosis of unknown origin, the model found significant overlap, indicating that these brain features are characteristic of psychosis in general.

A second mathematical model, trained to distinguish all subjects with 22q11.2 deletion syndrome and psychosis from those who have the genetic syndrome but without psychosis, selected brain scans from people with idiopathic psychosis with 77.5% accuracy, again supporting the idea that the brain’s filtering and predicting centers are key to psychosis.

Furthermore, this model was specific to psychosis: It could not classify people with idiopathic autism or ADHD.

“It was quite exciting to trace our steps back to our initial question — ‘What are the dysfunctional brain systems in schizophrenia?’ — and to discover similar patterns in this context,” Menon said. “At the neural level, the characteristics differentiating individuals with psychosis in 22q11.2 deletion syndrome are mirroring the pathways we’ve pinpointed in schizophrenia. This parallel reinforces our understanding of psychosis as a condition with identifiable and consistent brain signatures.” However, these brain signatures were not seen in people with the genetic syndrome but no psychosis, holding clues to future directions for research, he added.

Applications for treatment or prevention

In addition to supporting the scientists’ theory about how psychosis occurs, the findings have implications for understanding the condition — and possibly preventing it.

“One of my goals is to prevent or delay development of schizophrenia,” Supekar said. The fact that the new findings are consistent with the team’s prior research on which brain centers contribute most to schizophrenia in adults suggests there may be a way to prevent it, he said. “In schizophrenia, by the time of diagnosis, a lot of damage has already occurred in the brain, and it can be very difficult to change the course of the disease.”

“What we saw is that, early on, functional interactions among brain regions within the same brain systems are abnormal,” he added. “The abnormalities do not start when you are in your 20s; they are evident even when you are 7 or 8.”

Our discoveries underscore the importance of approaching people with psychosis with compassion.

The researchers plan to use existing treatments, such as transcranial magnetic stimulation or focused ultrasound, targeted at these brain centers in young people at risk of psychosis, such as those with 22q11.2 deletion syndrome or with two parents who have schizophrenia, to see if they prevent or delay the onset of the condition or lessen symptoms once they appear. 

The results also suggest that using functional MRI to monitor brain activity at the key centers could help scientists investigate how existing antipsychotic medications are working. 

Although it’s still puzzling why someone becomes untethered from reality — given how risky it seems for one’s well-being — the “how” is now understandable, Supekar said. “From a mechanistic point of view, it makes sense,” he said.

“Our discoveries underscore the importance of approaching people with psychosis with compassion,” Menon said, adding that his team hopes their work not only advances scientific understanding but also inspires a cultural shift toward empathy and support for those experiencing psychosis. 

“I recently had the privilege of engaging with individuals from our department’s early psychosis treatment group,” he said. “Their message was a clear and powerful: ‘We share more similarities than differences. Like anyone, we experience our own highs and lows.’ Their words were a heartfelt appeal for greater empathy and understanding toward those living with this condition. It was a call to view psychosis through a lens of empathy and solidarity.”

Researchers contributed to the study from UCLA, Clinica Alemana Universidad del Desarrollo, Pontificia Universidad Católica de Chile, the University of Oxford and UC Davis.

The study was funded by the Stanford Maternal and Child Health Research Institute’s Uytengsu-Hamilton 22q11 Neuropsychiatry Research Program, FONDEYCT (the National Fund for Scientific and Technological Development of the government of Chile), ANID-Chile (the Chilean National Agency for Research and Development) and the U.S. National Institutes of Health (grants AG072114, MH121069, MH085953 and MH101779).

About Stanford Medicine

Stanford Medicine is an integrated academic health system comprising the Stanford School of Medicine and adult and pediatric health care delivery systems. Together, they harness the full potential of biomedicine through collaborative research, education and clinical care for patients. For more information, please visit med.stanford.edu .

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The many roadblocks that keep women from getting mammograms

Yuki Noguchi

CDC research finds that in addition to cost and access, other factors of daily life keep many women from getting screened for breast cancer. ( Story aired on All Things Considered on 4/9/24 .)

MICHEL MARTIN, HOST:

Mammograms are critical in detecting breast cancer early, but everyday life challenges can get in the way of people getting that screening. New research from the Centers for Disease Control and Prevention points to some of the challenges people face in getting screened more often. NPR's Yuki Noguchi has more.

YUKI NOGUCHI, BYLINE: Guidelines recommend women over 40 get mammograms every other year. The new CDC report shows just over three-quarters of women aged 50 to 74 get their breast cancer screening. But if you look at those who don't, often they lack the money for a copay or transportation, or no one's reminded them to.

Deb Houry is chief medical officer at the CDC. She says the data show how economic hardships and emotional challenges are common barriers that prevent people from getting their mammograms.

DEB HOURY: We really see a cumulative impact. So what we saw was if you had three or more of these health-related social needs, that was when you really saw a difference in who wasn't getting the screening mammogram.

NOGUCHI: That difference is pretty stark - 65% with three or more of these social needs, like food insecurity, were able to get screened. That's compared to 83% of those not facing such challenges. Houry says the analysis shows the importance of physicians understanding more about how their patients' lives are shaped by various kinds of struggles, like paying for food and utilities.

HOURY: You're going to choose food over paying for a mammogram.

NOGUCHI: She says the research also shows that emotional factors also play a role in who seeks preventative care.

HOURY: I think if you're not feeling connected to others, you may not be going to medical care on a regular basis.

NOGUCHI: Houry says all of this new data should inform patient outreach.

HOURY: Providers can refer patients who have low income and are uninsured to those programs and health departments, as well, for free mammograms.

NOGUCHI: She says, in many cases, there are state and philanthropic programs offering free transportation or free mammograms, including ones funded by the CDC.

Yuki Noguchi, NPR News.

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