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Methodology Monday August Roundup
The latest #MethodologyMonday includes inputs from our consortium and focuses on an international Delphi survey and expert consensus process to develop standardised guidance for measuring and reporting ethnicity in clinical trials, addressing the current lack of consistency in how these data are collected.
It recommends a core set of 18 ethnicity-related variables, with self-identified ethnicity and/or race, country of birth, and language identified as the highest-priority variables for all trials, while recognising that some other measures are only relevant in specific contexts. The authors argue that adopting these recommendations will improve the inclusiveness, representativeness, and equity of clinical research by enabling better assessment of how health interventions affect diverse populations.
Recent research has increasingly focused on family-centred interventions in the ICU to improve both family and patient outcomes, but little emphasis has been placed on who these family members are. This systematic review aimed to describe the demographic characteristics of the family participants.
Fifty-eight RCTs were included, and most family participants were middle-aged women, while race/ethnicity was reported in only 34% of studies, with limited diversity among participants.
Reporting of key demographic variables remains inconsistent, constraining interpretation and generalisability. The authors emphasise that standardised and transparent reporting of demographic variables in ICU family research is essential to ensure that family-centred interventions are inclusive, equitable, and generalisable across diverse populations.
The following article argues that research that excludes or inadequately represents diverse populations produces biased evidence and weakens the validity and applicability of epidemiological findings. The authors site examples in cardiology and uterine fibroics among others to contend that diversity, equity, and inclusion should be viewed as scientific necessities rather than political or ethical add-ons, emphasising that social constructs such as race and ethnicity must be measured and interpreted carefully to identify the true structural drivers of health inequities. They conclude that more inclusive research practices are essential for generating robust evidence, reducing health disparities, and improving population health outcomes.
This article describes an ongoing pragmatic randomised clinical trial comparing pimavanserin and quetiapine for psychosis in people with Lewy body diseases, demonstrating that embedding research within routine clinical care substantially improved participant retention and increased enrolment of Hispanic participants compared with traditional explanatory trials. The pragmatic design reduced common barriers to participation by integrating study procedures into standard care, using broad eligibility criteria, minimising additional visits, and providing bilingual recruitment and study materials. The authors conclude that pragmatic trial designs can improve the diversity, representativeness, and real-world applicability of clinical research while maintaining high participant retention, offering a promising strategy for more equitable neurological clinical trials.
This editorial argues that equity, diversity and inclusion (EDI) are fundamental to producing rigorous, generalisable diabetes research, as underrepresentation of diverse populations in clinical trials and genomic studies limits scientific validity and contributes to health inequities. It highlights how social, environmental and structural factors—alongside biological differences—shape diabetes risk and outcomes, and calls for more inclusive research practices that accurately reflect global population diversity. The authors conclude that journals, researchers and funders should actively embed EDI principles and established reporting frameworks into research to improve scientific quality, ethical standards and health outcomes worldwide.
