Outcome reporting in randomized controlled trials and systematic reviews of gastroschisis treatment: a systematic review.

BACKGROUND

Core outcome sets (COS) facilitate clinical research by providing an agreed set of outcomes to be measured when evaluating treatment efficacy. Gastroschisis is increasing in frequency and evidence-based treatments are lacking. We aimed to identify initial candidate outcomes for a gastroschisis COS from existing literature.

METHODS

Using a sensitive search strategy we identified randomized controlled trials (RCTs) and systematic reviews (SRs) of treatment interventions for gastroschisis. Outcomes were extracted and assigned to the core areas, 'Pathophysiological Manifestations', 'Life Impact', 'Resource Use', 'Adverse Events' and 'Mortality'.

RESULTS

A total of 50 outcomes were identified. RCTs reported 6-9 outcomes each; SRs reported 9-25. The most frequently reported outcomes were 'Length of hospital stay' (reported in 8 studies), 'Duration of ventilation' and 'Time to full enteral feeds' (7 studies). Outcomes identified could be assigned to all five core areas.

CONCLUSIONS

There is wide heterogeneity in outcomes reported in studies evaluating treatment interventions for gastroschisis. It is unclear which outcomes are of highest importance across stakeholder groups. Developing a COS to standardize outcome measurement and reporting for gastroschisis is warranted.