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.

Developing a core outcome measurement set for clinical trials in acute diarrhoea / Karas, Jacek; Ashkenazi, Shai; Guarino, Alfredo; LO VECCHIO, Andrea; Shamir, Raanan; Vandenplas, Yvan; Szajewska, Hania. - In: ACTA PAEDIATRICA. - ISSN 0803-5253. - 105:4(2016), pp. e176-e180. [10.1111/apa.13349]

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

GUARINO, ALFREDO;LO VECCHIO, ANDREA;
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.
2016
Developing a core outcome measurement set for clinical trials in acute diarrhoea / Karas, Jacek; Ashkenazi, Shai; Guarino, Alfredo; LO VECCHIO, Andrea; Shamir, Raanan; Vandenplas, Yvan; Szajewska, Hania. - In: ACTA PAEDIATRICA. - ISSN 0803-5253. - 105:4(2016), pp. e176-e180. [10.1111/apa.13349]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/642670
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