Core outcome sets are the baseline for what should be measured in clinical research and, thus, should serve as a guide for what should be collected and reported. The Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials (COMMENT), established in 2012, agreed that consensus on a core set of outcomes with agreed upon definitions that should be measured and reported in clinical trials was needed. To achieve this goal, six working groups (WGs) were set up, including the WG on Acute Diarrhea, whose main goal was to develop a core outcome set for trials in acute diarrhea.
Results
For therapeutic studies, the five most important outcome measures were diarrhea duration, degree of dehydration, need for hospitalization (or duration of hospitalization for inpatients), the proportion of patients recovered by 48 hours, and adverse effects. The prophylactic core outcome set included prevention of diarrhea, prevention of dehydration, prevention of hospitalization, and adverse effects.
Conclusions
The outcome sets for therapy and prevention can be recommended for use in future trials of patients with gastroenteritis. Their envisioned goal is to decrease study heterogeneity and to ease the comparability of studies. The WG’s next step is to determine how to measure the outcomes included in the core set.
Core outcome set complete / Work in progress on core outcome measurement set
Jacek Karas, Shai Ashkenazi, Alfredo Guarino, Andrea Lo Vecchio, Raanan Shamir4, Yvan Vandenplas, Hania Szajewska on behalf of the Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials (COMMENT)
Disease Category: Child health, Gastroenterology
Disease Name: Acute diarrhoea
Age Range: 0 - 5
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Researchers
- Recommendations for outcome measures (measurement/how)
- Survey
- Systematic review