Back to Search Start Over

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

Authors :
Karas, Jacek
Ashkenazi, Shai
Guarino, Alfredo
Lo Vecchio, Andrea
Shamir, Raanan
Vandenplas, Yvan
Szajewska, Hania
Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials (COMMENT)
Karas, Jacek
Ashkenazi, Shai
Guarino, Alfredo
LO VECCHIO, Andrea
Shamir, Raanan
Vandenplas, Yvan
Szajewska, Hania
Growth and Development
Clinical sciences
Source :
Acta Paediatrica. 105:e176-e180
Publication Year :
2016
Publisher :
Wiley, 2016.

Abstract

Aim 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. Conclusion The outcome measurement set can be used to evaluate therapeutic or preventive strategies and can be recommended for use in future acute diarrhoea trials.

Details

ISSN :
08035253
Volume :
105
Database :
OpenAIRE
Journal :
Acta Paediatrica
Accession number :
edsair.doi.dedup.....bfd5856534c1779abc7face46f5f2923