Developing a core outcome measurement set for clinical trials in acute diarrhoea.

Abstract

The Working Group on Acute Diarrhoea, part of The Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials, previously developed a core outcome set for clinical trials on acute diarrhoea. This study aimed to create a core outcome measurement set to complement it. The study had three phases. The first identified how the literature defined core outcome measures in clinical trials on acute diarrhoea and measured outcomes. The second phase used a questionnaire to seek the views of 109 leading researchers and clinicians in this specialist field. The third phase achieved a consensus on the core outcome measurement set. First, we identified 52 different measurement instruments or definitions. A questionnaire was then used to ask our experts what they thought were the most valid core outcome measurement instruments or definitions for each measure and 53 (49%) responded. Core outcome measurement instruments were then developed, including definitions of diarrhoea and acute gastroenteritis, diarrhoea duration, dehydration, the need for hospitalisation, discharge criteria and duration of hospitalisation. The outcome measurement set can be used to evaluate therapeutic or preventive strategies and can be recommended for use in future acute diarrhoea trials.