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Reporting outcome measures in trials of infant colic
Nina F Steutel1, Marc A Benninga, Miranda W Langendam
1*Department of Pediatric Gastroenterology and Nutrition, Emma Children's Hospital/Academic Medical Center †Dutch Cochrane Centre, Academic Medical Center, University of Amsterdam, Amsterdam ‡Department of Pediatrics, Zuwe Hofpoort Ziekenhuis, Woerden, The Netherlands.
Insights
Infant colic research lacks standardized definitions and outcome measures, hindering study comparisons. This review highlights the need for uniform criteria in randomized controlled trials for infant colic.
Area of Science:
- Pediatrics
- Clinical Research Methodology
Background:
- Infant colic (IC) affects 5-25% of infants, incurring significant healthcare costs.
- Potential negative sequelae include disturbed parent-infant interaction and increased susceptibility to abdominal pain.
- The unknown etiology of IC contributes to diverse and often unvalidated interventions.
Purpose of the Study:
- To systematically assess the heterogeneity in definitions and outcome measures used in randomized controlled trials (RCTs) for infant colic.
- To identify the range of interventions and reported outcomes in existing IC research.
Main Methods:
- Searched CENTRAL, Embase, and MEDLINE/PubMed databases from inception to December 2012.
- Included English-language systematic reviews (SRs) and RCTs on infant colic in infants aged 0-9 months.
- Assessed study quality using the Delphi list and reviewed bibliographies of included SRs.
Main Results:
- A total of 55 articles (16 SRs, 39 RCTs) were included from 1702 identified studies.
- Significant heterogeneity was found: 20 different definitions for IC, 11 for improvement, 28 interventions, and 19 outcomes across 39 trials.
- While 51% of trials were of good methodological quality and all used parental diaries, only 31% reported validated instruments.
Conclusions:
- There is a critical lack of uniformity in definitions and outcome measures for infant colic in RCTs.
- Parental perception was rarely the primary outcome in the reviewed trials.
- Standardized definitions, outcomes, and validated instruments are essential for comparing intervention effectiveness in infant colic research.
Objectives:
Infant colic (IC), with an estimated prevalence of 5% to 25%, has a high impact on health care costs. Furthermore, reported negative sequelae are disturbed parent-infant interaction, increased susceptibility to abdominal pain, and even child abuse. Its etiology remains unknown, leading to a wide variety in interventions. We hypothesize that definitions and outcome measures in studies on IC will be heterogeneous as well. Our objective is to systematically assess how definitions and outcome measures are reported in randomized controlled trials (RCTs) of IC.
Methods:
CENTRAL, Embase, and MEDLINE/PubMed were searched from inception to December 2012. English-language systematic reviews (SRs) and RCTs concerning IC in children ages 0 to 9 months were included. Bibliographies of included SRs were searched for additional articles. Quality was assessed using the Delphi list.
Results:
A total of 1702 studies were found; 55 articles were included (16 SRs, 39 RCTs). In 39 trials, we found 20 different definitions for IC, 11 different definitions for improvement, 28 different interventions, and 19 different outcomes. Fifty-one percent of the trials were of good methodological quality. All of the trials used parental diaries; only 31% stated that their instrument was validated.
Conclusions:
Too many different definitions and outcome measures for IC are used in RCTs. Only a minority of the trials reported parental perception as primary outcome. Uniform definitions, outcomes, and validated instruments are needed to make a comparison between intervention studies possible.
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