Vascular Surgery Guidelines Sideline Women's Health Data, Study Finds
A major review of European vascular surgery guidelines reveals women are significantly underrepresented in the clinical evidence supporting treatment recommendations for peripheral artery disease and limb-threatening infections. The gap could mean women receive care protocols designed primarily around male patient data, raising quality and liability concerns for hospitals and insurers.
Originaltitel: Evaluation of Sex Specific Representation and Sex Disaggregated Reporting in European Society for Vascular Surgery Clinical Practice Guidelines on the Management of Peripheral Arterial Disease and Chronic Limb Threatening Ischaemia.
Europeiska vaskulärkirurgiska riktlinjer för perifera artärsjukdomar saknar könsuppdelad rapportering och underrepresenterar kvinnor i den vetenskapliga underlaget — en lucka som försvagar evidensens tillämplighet för hälften av patientpopulationen. En granskning av 213 studier för PAD-rekommendationer och 116 för CLTI-rekommendationer visade att endast 21 procent respektive cirka 10 procent rapporterade könsuppdelad data. Sex-stratifierade utfall rapporterades i bara 10 procent och 2 procent av studierna. Kvinnor var underrepresenterade i cirka 63 procent (PAD) respektive 55 procent (CLTI) av studierna. Deltagarpopulationen var könsokänd i cirka 42 och 39 procent. Multinationella studier med fler kvinnliga författare och högre evidensnivå korrelerade med bättre kvinnlig enrollment. Kvinnlig författarskap förband sig med högre sannolikhet för könsuppdelad rapportering. För inköpschefer och regulatoriska specialister signalerar detta ett behov av striktare evidenskrav vid guideline-utveckling för att säkerställa patientnära relevans.
OBJECTIVE: The aim of this study was evaluate the extent to which women are represented and reported within the scientific evidence supporting the clinical practice guidelines on peripheral arterial disease (PAD) and chronic limb threatening ischaemia (CLTI). DATA SOURCES: Data were extracted from all studies supporting recommendation statements within the European Society for Vascular Surgery (ESVS) 2024 clinical practice guidelines on the management of PAD and the 2019 global vascular guidelines on the management of CLTI, including study type, journal impact factor, year of publication, country, sex of authors, participant sex, use of a sex stratified main outcome, and sex disaggregated reporting. REVIEW METHODS: The protocol was registered with PROSPERO (CRD42024559537) and conducted in accordance with PRISMA-Equity guidelines. Analyses were performed using RStudio. Under enrolment was defined as a participation prevalence ratio (PPR) < 0.8. Binary logistic regression evaluated factors associated with reporting sex stratified outcomes; weighted linear regression assessed factors linked to increased PPR. RESULTS: Of 89 PAD and 113 CLTI recommendations, 213 and 116 unique studies were analysed. The remaining references were consensus documents or were excluded due to reasons such as single sex populations. Only 21% and ∼10% of the studies reported sex disaggregated data, while only 10% and 2% reported sex stratified outcomes in PAD and CLTI, respectively. Participants' sex was unreported in ∼42% (PAD) and ∼39% (CLTI). Women were under enrolled in ∼63% (PAD) and ∼55% (CLTI) of studies. Multinational studies, higher proportion of women authors, and stronger evidence levels were associated with better women's enrolment. Women first authorship was associated with increased odds of sex stratified reporting. Other factors that influenced sex stratified reporting included more women participants, a higher proportion of women authors, and recent publication year. CONCLUSION: Women are under represented and under reported in the evidence underpinning ESVS PAD and CLTI guidelines. Future societal guidelines should be based on research with balanced inclusion and consistent sex specific reporting.