Psychosocial and contextual patient factors in RCTs for asthma and type 2 diabetes

Abstract Background Chronic conditions like asthma and type 2 diabetes remain major causes of morbidity and mortality, requiring sustained patient engagement. Health psychology shows that such engagement varies due to psychosocial and contextual factors. While clinicians often adapt care intuitively, these influences are under-reported in randomised controlled trials (RCTs). Aim To identify and map psychosocial and contextual patient factors reported in RCTs for asthma and type 2 diabetes Methods A systematic MEDLINE (OVID) search identified English-language RCTs on adult asthma or type 2 diabetes, published from 01/01/2019. Fifty trials per condition were selected. Data on study design, participants, baseline and subgroup variables were extracted and categorised using a pre-existing framework Results Asthma: • 1,030 reports identified; 600 screened; 124 full texts reviewed; • 715 baseline items: 86.2% biological, 13.8% psychosocial/contextual; • 42 subgroup analyses: 76% biological, 24% psychosocial/contextual. Type 2 Diabetes: • 3,910 reports identified; 500 screened; 79 full texts reviewed; • 715 baseline items: 86.2% biological, 13.8% psychosocial/contextual; • 41 subgroup analyses: 76% biological, 24% psychosocial/contextual. Key Findings: Most reported variables were biological or clinical. Psychosocial and contextual factors were rarely assessed or analysed, despite their relevance to patient engagement Discussion The limited inclusion of psychosocial/contextual factors may reduce RCT generalisability and lead to less effective, less personalised care. Public Health Implications: • Personalisation: Supports more tailored, effective care; • Policy: Informs policies promoting broader factor inclusion; • Equity: Helps reduce disparities through inclusive strategies; • Research: Highlights need for tools to measure these factors. Conclusions Broader inclusion of psychosocial and contextual factors in RCTs is essential to improve generalisability, outcomes, and equity in chronic disease care. Key messages • Psychosocial factors are rarely assessed in RCTs, limiting generalisability and missing key influences on patient engagement and outcomes. • Including psychosocial factors in research can improve patient outcomes, support personalised care, and advance health equity.