title: Developing a core outcome measurement set for clinical trials in acute diarrhoea.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  The outcome measurement set can be used to evaluate therapeutic or preventive strategies and can be recommended for use in future acute diarrhoea trials.
authors.affiliation: Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
authors.forename: Jacek
authors.initials: J
authors.lastname: Karas
authors.affiliation: Schneider Children's Medical Center, Petach-Tikva, and Felsenstein Medical Research Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Shai
authors.initials: S
authors.lastname: Ashkenazi
authors.affiliation: Department of Translational Medical Science, Section of Pediatrics, University of Naples Federico II, Naples, Italy.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Guarino
authors.affiliation: Department of Translational Medical Science, Section of Pediatrics, University of Naples Federico II, Naples, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Lo Vecchio
authors.affiliation: Institute for Gatroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center, Petach-Tikva, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Raanan
authors.initials: R
authors.lastname: Shamir
authors.affiliation: Department of Pediatrics, UZ Brussel, Vrije Universiteit Brussel, Brussel, Belgium.
authors.forename: Yvan
authors.initials: Y
authors.lastname: Vandenplas
authors.affiliation: Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
authors.forename: Hania
authors.initials: H
authors.lastname: Szajewska
mesh_terms: D002986:Clinical Trials as Topic; D003967:Diarrhea / Q000628:therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*
keywords: Consensus; Diarrhoea; Gastroenteritis; Outcome measures; Paediatrics