A core outcome set for clinical trials in acute diarrhoea
Abstract
OBJECTIVE: 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, 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 setup, including WG on acute diarrhoea, whose main goal was to develop a core outcome set for trials in acute diarrhoea. METHODS: The first step identified how published outcomes related to acute diarrhoea were reported. The second focused on the methodology for determining which outcomes to measure in clinical trials. The third employed a two-phase questionnaire study using the Delphi technique to define clinically important outcomes to clinicians and parents. RESULTS: For therapeutic studies, the five most important outcome measures were diarrhoea duration, degree of dehydration, need for hospitalisation (or duration of hospitalisation for inpatients), the proportion of patients recovered by 48 h and adverse effects. The prophylactic core outcome set included prevention of diarrhoea, prevention of dehydration, prevention of hospitalisation 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. WG's next step is to determine how to measure the outcomes included in the core set.
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The study was conducted entirely in English, which introduced a limitation about whether all participants fully understood what was being asked of them.
“Whilst the study was conducted entirely in English, the study steering group was keen to ensure that participants from nations where English is not a first language were involved. This introduced a further limitation about whether all participants fully understood what was being asked of them and further research to explore the impact of this is indicated.32”
From International Consensus on a Dental Antibiotic Stewardship Core Outcome Set (2023) · cites this paper as [32]
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Use of Probiotics for the Management of Acute Gastroenteritis in Children: An Update
Szajewska, H., Guarino, A., Hojsak, I., Indrio, F., Kolacek, S., Orel, R., Salvatore, S., Shamir, R., van Goudoever, J. B., Vandenplas, Y., et al. (2020) · Journal of Pediatric Gastroenterology and Nutrition · doi:10.1097/mpg.0000000000002751 · Cited by 90 · see citing works
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“This introduced a further limitation about whether all participants fully understood what was being asked of them and further research to explore the impact of this is indicated.(32) A related strength, however, was the inclusion of participants from a diversity of countries, including 8 low-”
BackgroundDeveloping a core outcome set for periodontal trials
Lamont, T. J., Clarkson, J. E., Ricketts, D. N. J., Heasman, P. A., Ramsay, C. R., & Gillies, K. (2021) · PLoS ONE · doi:10.1371/journal.pone.0254123 · Cited by 25 · see citing works
- Authors
- Karas, J., Ashkenazi, S., Guarino, A., Lo Vecchio, A., Shamir, R., Vandenplas, Y., & Szajewska, H.
- Affiliations
- Tel Aviv University (IL)
- Federico II University Hospital (IT)
- Vrije Universiteit Brussel (BE)
- Medical University of Warsaw (PL)
- Corresponding author
- Szajewska, Hania
- Venue
- Archives of Disease in Childhood
- Publisher
- BMJ
- Published
- 2014-11-20
- Volume
- 100
- Issue
- 4
- Pages
- 359-363
- ISSN
- 0003-9888 (ISSN-L)
- 1468-2044
- OpenAlex
- W2170654201
- Cited by
- 42
- References
- 11
- Citations by year
- 2026: 1 · 2025: 2 · 2023: 2 · 2022: 7 · 2021: 4 · 2020: 3 · 2019: 2 · 2018: 4 · 2017: 9 · 2016: 6 · 2015: 2
- FWCI
- 18.46
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Disease in Childhood (publishedVersion)
- PubMed (publishedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Topics
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Health Sciences › Medicine › Infectious Diseases › Viral gastroenteritis research and epidemiology
- Health Sciences › Nursing › Nutrition and Dietetics › Clinical Nutrition and Gastroenterology
- Keywords
- core outcome set, acute diarrhea, gastroenteritis, pediatric clinical trials, outcome measurement, dehydration, hospitalization, diarrhea duration, diarrhea prevention, adverse effects, trial heterogeneity
- MeSH terms
- Acute Disease, Child, Clinical Trials as Topic, Delphi Technique, Diarrhea, Humans, Parents, Pilot Projects, Surveys and Questionnaires, Treatment Outcome
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