Reporting of baseline characteristics in gastrointestinal cancer: A systematic review of surgical randomised controlled trials

Background

Randomised controlled trials (RCTs) underpin surgical practice, but external validity depends on transparent reporting of participant characteristics. In gastrointestinal (GI) cancer surgery, socio-demographic factors influence outcomes, yet the extent to which these are reported in surgical RCTs remains unclear. This review evaluated reporting of baseline characteristics and equality, diversity, and inclusion (EDI) considerations in contemporary trials.

Methods

Systematic searches of MEDLINE, EMBASE, and CENTRAL identified RCTs of surgical interventions for GI malignancies published in journals with an impact factor ≥7.5. Two reviewers independently screened studies and extracted data. Reporting of eligibility criteria, baseline characteristics, and equality, diversity, and inclusion (EDI)–related statements was narratively synthesised.

Results

Thirty-two RCTs including 9370 patients were analysed. Age and sex were reported in 93.8% of trials, and body mass index in 65.6%. No trial reported disability status, pregnancy status, ethnicity, socioeconomic status, or sexual orientation. Exclusions relating to older adults (≥80 years) and pregnancy were common, but explanations were infrequently reported. Only 40.6% of trials discussed generalisability.

Conclusion

Reporting of participant characteristics in GI cancer surgery RCTs remains limited. Despite journal-level EDI guidance, demographic reporting beyond age and sex is uncommon, constraining assessment of external validity.