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Where clinical guidelines get sex and gender wrong


When I was pregnant with my son, I was told I couldn’t have a water birth because my BMI was too high. Frustrated by this blanket restriction, I did what any self-respecting researcher would do: I went down a rabbit hole of scientific literature.

What I discovered shocked me. BMI was originally devised by a 19th-century mathematician to describe population averages, not individual health (Rubino et al., 2025). And when researchers established it as a measure of body fatness in 1972 (Keys et al., 1972), their landmark study included 7,424 participants. Every single one was a man.

Here I was, 50 years later, having decisions made about my pregnancy and childbirth using a measure whose scientific foundations had nothing to do with pregnant women, or any women for that matter.

Unfortunately, this reflects a much wider problem. Women have historically been under-represented in medical research (Daitch et al., 2022), while transgender and gender-diverse populations have also frequently been overlooked (Schonrock et al., 2024). In mental health research the pattern is often reversed: men made up only around a quarter of participants in trials of psychological and lifestyle treatments for depression (Knox et al., 2022), and are under-enrolled in psychiatry trials more broadly (Steinberg et al., 2021). These consequences extend to clinical practice guidelines, which translate research evidence into recommendations for healthcare professionals, which in turn, translates into inequitable healthcare for different genders.

To address this gap, Tania King and colleagues embarked on a programme of research to improve the inclusion of sex and gender considerations in clinical practice guidelines.

Medical research has historically focused on men, leaving women and gender-diverse populations under-represented in the evidence underpinning clinical practice guidelines. But how can we ensure equitable healthcare when the evidence doesn’t reflect the people receiving it?

Methods

The researchers used two complementary approaches.

First, an umbrella review synthesised existing reviews examining how sex and gender are incorporated into clinical practice guidelines (Sitohang et al., 2026). Eight databases were searched for English-language reviews published since 2000. Eligible studies included systematic, scoping and other non-specific reviews. Screening, data extraction and quality appraisal were conducted independently by two reviewers, following Joanna Briggs Institute (JBI) methodology. Findings were synthesised narratively rather than statistically.

Second, semi-structured qualitative interviews were conducted with Australian experts, exploring barriers and opportunities for improving sex and gender inclusion (Maheen et al., 2026). Participants were recruited through professional networks, targeted invitations and snowball sampling. Interviews were analysed using framework analysis, combining inductive coding (themes emerging from the interviews) with deductive coding (informed by existing evidence). Two researchers contributed to developing the analytical framework. People with lived experience also helped refine the research question and the interview guide.

Results

The umbrella review included seven reviews covering 784 clinical practice guidelines across different countries and clinical conditions. All seven reviews were assessed as being of good or moderate methodological quality.

A total of 28 participants took part in a semi-structured interview including 12 clinicians, 8 academics/researchers, 6 guideline developers and 2 others (a not-for-profit and an advocacy organisation).

How well are sex and gender currently incorporated into clinical practice guidelines?

Although 69% (538/784) of guidelines mentioned sex and/or gender, their inclusion was often superficial. Among 235 guidelines assessed for terminology, 59% (138) used sex and gender interchangeably. More importantly, among 206 non-pregnancy-related guidelines that mentioned sex or gender, just 15% (31) incorporated these considerations into diagnostic or management recommendations.

What prevents better inclusion?

The umbrella review identified four main barriers:

  1. Limited diversity and sex/gender expertise among guideline development committees.
  2. Gaps in the evidence base, including the historical under-representation of women in research.
  3. Inconsistent definitions and use of sex and gender terminology.
  4. A lack of systematic guidance on incorporating sex and gender into guideline development.

Qualitative interviews reinforced these findings, particularly the lack of sex- and gender-disaggregated evidence. Participants also highlighted that guidelines can lag behind emerging research, even where the evidence base has become more inclusive. A concerning cycle emerged: insufficient evidence discourages guideline developers from addressing sex and gender differences, while continued inaction perpetuates these evidence gaps.

The interviews also highlighted the politicisation of sex and gender as an additional barrier. Participants described how political narratives, including framing transgender inclusion as a threat to women’s rights, can create confusion and resistance to more inclusive clinical guidance.

How can guidelines be improved?

Across both studies, researchers identified several strategies:

  1. More inclusive committees: Involve women, transgender and gender-diverse people, people with lived experience and experts in sex and gender.
  2. Better training: Equip guideline developers with the knowledge and skills to recognise relevant differences and use appropriate terminology.
  3. Systematic integration: Consider sex and gender throughout guideline development, from formulating research questions to appraising evidence and developing recommendations.
  4. Stronger evidence: Improve representation in research, report findings separately by sex and gender where appropriate, and acknowledge evidence gaps.
  5. Actionable recommendations: Translate evidence into specific diagnostic and treatment guidance, rather than simply acknowledging differences.
  6. Greater accountability: Establish clear requirements and standards through funders, publishers and guideline organisations.
  7. Consistent, accurate and inclusive terminology: Adopt standardised definitions that clearly distinguish between sex and gender, while using inclusive language that recognises gender diversity without obscuring clinically relevant biological differences.
  8. Intersectional approaches: Consider how sex and gender interact with factors such as age, ethnicity, disability and culture, and involve diverse communities in developing guidelines that reflect their needs.
Although 69% of clinical practice guidelines mentioned sex or gender, meaningful inclusion was far less common. Just 15% of guidelines assessed in a relevant subset incorporated these considerations into diagnostic or treatment recommendations.

Conclusions

Together, these studies highlight a substantial gap between acknowledging sex and gender differences in clinical practice guidelines and translating these differences into meaningful clinical recommendations. Although sex and gender were mentioned in most guidelines, their inclusion was often superficial, inconsistent or limited to reproductive health.

The findings suggest that improving sex and gender inclusion requires more than simply strengthening the evidence base. Greater diversity and expertise among guideline developers, standardised processes, clearer terminology and stronger institutional accountability are also needed. Ultimately, a more systematic and inclusive approach to guideline development is essential to ensure that clinical recommendations reflect the needs of diverse populations.

Improving sex and gender inclusion requires more than simply strengthening the evidence base.

Strengths and limitations

A key strength of this research is the use of complementary methodologies. The umbrella review provides evidence of how sex and gender are currently incorporated into clinical practice guidelines, while the qualitative interviews offer insight into why gaps persist and how they might be addressed. Together, they provide a more comprehensive picture than either study could offer alone.

The umbrella review followed established JBI methodology, with a registered protocol, independent screening, data extraction and quality appraisal. However, I have some reservations about the inclusion of non-systematic reviews. Three of the seven included reviews did not specify a review methodology. Although all were rated as good or moderate quality, these assessments cannot necessarily establish whether the original searches comprehensively identified relevant guidelines. This raises questions about how representative the 784 guidelines are of clinical practice guidelines more broadly. Furthermore, restricting inclusion to English-language, peer-reviewed publications may have excluded important evidence from non-English-speaking countries, limiting the review’s global applicability.

The qualitative study included a diverse range of professional perspectives, and its systematic framework analysis strengthens confidence in the findings. However, all 28 participants were based in Australia. This is particularly important given that the findings are intended to inform guidance for guideline developers internationally. Although the umbrella review incorporated international evidence, guideline development processes, resources and governance structures vary considerably between countries. Further consultation with international stakeholders may therefore be necessary to establish whether the proposed guidance is applicable and feasible across different healthcare systems.

The involvement of people with lived experience also warrants reflection. Although increasingly recognised as good practice, involvement should have a clearly defined purpose rather than being treated as an automatic indicator of research quality (Greenhalgh et al., 2019; Oliver et al., 2019). The authors report that people with lived experience helped refine the research question and interview guide, and were consulted on the final guide. Given that this study focused on the technical and organisational processes of guideline development, it is worth considering what specific contribution lived experience expertise was intended to make at these stages, and where it could most meaningfully inform the research.

Combining an umbrella review with qualitative interviews offers valuable insights, but questions remain about the quality of the underlying evidence, the international applicability of the findings, and how best to involve people with lived experience.

Implications for practice

King and colleagues (King et al., 2026) bring together findings from their programme of research to develop a practical guide for incorporating sex and gender considerations throughout clinical practice guideline development. Aligned with internationally recognised guideline development frameworks, the guide provides recommendations across seven stages, summarised below.

Guideline development stage What do King and colleagues recommend?
1. Establishing guideline development groups Ensure diverse representation, aiming for at least 40% women. Include sex and gender experts and, where relevant, people with lived experience.
2. Scoping the guideline Identify relevant sex and gender differences in disease presentation, diagnosis, treatment, healthcare access and outcomes. Consider evidence gaps and potential inequalities from the outset.
3. Reviewing the evidence Include sex- and gender-specific search terms, extract disaggregated data, assess whether different populations are adequately represented, and consider differences in treatment effectiveness and safety.
4. Developing recommendations Consider how recommendations might affect different sex and gender populations. Provide separate recommendations where clinically justified, and explicitly acknowledge uncertainty where evidence is insufficient.
5. Structuring the guideline Include a glossary defining sex and gender terminology. Use terms accurately and consistently, and ensure language is inclusive and clinically appropriate.
6. Public consultation Seek feedback from diverse sex and gender populations, particularly about unintended consequences, barriers to care and the acceptability of recommendations.
7. Implementation and evaluation Clearly identify evidence gaps, monitor whether recommendations produce equitable outcomes across populations, and update guidelines as new evidence emerges.

The next challenge will be translating this framework into practice. International consultation, implementation research and evaluation will be needed to establish whether it is feasible across different healthcare systems and, importantly, whether it improves clinical recommendations and patient outcomes.

As a researcher, I have always been fascinated by sex and gender differences. Throughout my career, I have specialised in topics such as suicide and violence, where these differences are particularly pronounced (Eager, 2022; Marzecki, 2025). It strikes me as odd that research so often treats sex and gender as variables to adjust for, rather than potentially important influences on people’s experiences, behaviours and healthcare needs. Encouragingly, this is beginning to change. From January 2026, Australia’s two major public health and medical research funders, the NHMRC and MRFF, introduced requirements for funding applicants to explicitly consider sex and gender, among other relevant variables, throughout the research process. Although these changes cannot be attributed directly to King and colleagues’ research, they suggest that the broader push for more inclusive, representative evidence is beginning to translate into research policy.

But above all, as a woman, I cannot help feeling that we need to do better.

At a recent suicide prevention conference, I almost choked on my tea when Australia’s Special Envoy for Men’s Health declared that our healthcare system was not fit for purpose for men. I was genuinely astonished. For generations, medical research has disproportionately studied male bodies, treating men as the default and women as an afterthought. And yet here we were, being told that the very system built around men was failing them.

Of course, the irony is that he wasn’t necessarily wrong. Men experience substantial health inequalities, not least in suicide prevention. But surely this is precisely the point? A healthcare system built around male bodies is not necessarily one that understands men’s needs, any more than it understands women’s. The problem isn’t that one gender has been overlooked while another has been adequately served. It’s that we have built an evidence base that fails to adequately account for the different biological, social and psychological realities of the people it is supposed to serve.

This brings me back to one of the qualitative study’s most concerning findings: the politicisation of sex and gender. Against the backdrop of the growing influence of the manosphere and the global rise of right-wing political movements, I worry that we are becoming increasingly entrenched in an ‘us versus them’ mentality, where advancing the rights and wellbeing of women, men and gender-diverse people is treated as a zero-sum game, as though progress for one group must inevitably come at the expense of another. When even the science of sex and gender becomes a political battleground, I fear that the very real healthcare needs of different populations risk being lost in the noise.

Perhaps King and colleagues can’t save us from the politics of sex and gender, but they’ve certainly given us a better starting point for getting the science right.

When sex and gender become political battlegrounds, we risk losing sight of what really matters: ensuring that everyone receives healthcare that meets their needs.

Statement of interests

Laura Hemming has no potential conflicts of interests. AI was used to help edit and refine the writing of this blog.

Edited by

André Tomlin

Links

Marya Sitohang, Jennifer Ervin, Humaira Maheen, Kim Dalziel & Tania King (2026). Inclusion of sex and gender in clinical practice guidelines: an umbrella review. BMJ Open Quality, 15(3), e004211.

Humaira Maheen, Jennifer Ervin, Marya Sitohang & Tania King (2026). Perspectives on sex and gender inclusion in clinical practice guidelines: a qualitative study. BMJ Open, 16(9), e120086.

Tania King, Jennifer Ervin, Marya Sitohang, Kim Dalziel, Michelle Tew, Cara Tannenbaum & Humaira Maheen (2026). A Guide for the Inclusion of Sex and Gender Considerations in Clinical Practice Guidelines. Clinical and Public Health Guidelines, 3(4), e70087.

Other references

Daitch, V., Turjeman, A., Poran, I., Tau, N., Ayalon-Dangur, I., Nashashibi, J., Yahav, D., Paul, M., & Leibovici, L. (2022). Underrepresentation of women in randomized controlled trials: a systematic review and meta-analysis. Trials, 23(1), 1038.

Eager S. Does the relationship between loneliness and suicidal ideation vary between men and women of different ages? The Mental Elf. 20 June 2022.

Greenhalgh, T., Hinton, L., Finlay, T., Macfarlane, A., Fahy, N., Clyde, B., & Chant, A. (2019). Frameworks for supporting patient and public involvement in research: systematic review and co‐design pilot. Health Expectations, 22(4), 785–801.

Keys, A., Fidanza, F., Karvonen, M. J., Kimura, N., & Taylor, H. L. (1972). Indices of relative weight and obesity. International Journal of Epidemiology, 43(3), 655–665.

Knox J, Morgan P, Kay-Lambkin F, et al. (2022). Male involvement in randomised trials testing psychotherapy or behavioural interventions for depression: a scoping review. Current Psychology.

Marzecki F. Domestic violence and suicide in women: insights from a national UK study. The Mental Elf. 18 November 2025.

Oliver, K., Kothari, A., & Mays, N. (2019). The dark side of coproduction: do the costs outweigh the benefits for health research? Health Research Policy and Systems, 17(1), 33.

Rubino, F., Cummings, D. E., Eckel, R. H., Cohen, R. V, Wilding, J. P. H., Brown, W. A., Stanford, F. C., Batterham, R. L., Farooqi, I. S., & Farpour-Lambert, N. J. (2025). Definition and diagnostic criteria of clinical obesity. The Lancet Diabetes & Endocrinology, 13(3), 221–262.

Schonrock, Z., Brackeen, S., Delarose, K. E., Tran, T. Q., & Cirrincione, L. R. (2024). Transgender people in clinical trials of drugs and biologics: An analysis of ClinicalTrials. gov from 2007 to 2023. British Journal of Clinical Pharmacology, 90(10), 2332–2342.

Steinberg JR, Turner BE, Weeks BT, et al. (2021). Analysis of female enrollment and participant sex by burden of disease in US clinical trials between 2000 and 2020. JAMA Network Open, 4(6), e2113749.

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