Development of a core outcome set for infant colic

Article type
Authors
Steutel NF1, Korterink JJ2, Benninga MA2, Langendam MW3, Tabbers MM2
1Dept Clinical Epidemiology, Biostatistics and Bioinformatics and Dept Pediatric Gastroenterology and Nutrition, Academic Medical Centre, The Netherlands
2Dept Pediatric Gastroenterology and Nutrition, Academic Medical Centre, The Netherlands
3Dept Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, The Netherlands
Abstract
Background and objectives: Infant colic (IC) is a common problem with a worldwide prevalence of 5% to 25%. This self-limiting disorder can have negative long-term consequences. So far, its etiology remains unknown, resulting in a wide variety in interventions. A previous study showed heterogeneous outcome measures are used across therapeutic trials of IC. To facilitate and improve evidence synthesis, development of a core outcome set (COS) is necessary.
Methods: In 2014, 133 health care professionals (HCPs) participated in a survey that investigated which outcome measures they used to guide their decision making when treating IC. Every outcome that was mentioned by 10% or more of the respondents was carried forward to Phase 2. Of the respondents to Phase 1, 68 (51%) agreed to complete a second questionnaire. HCPs were then asked to rate the outcomes and to select the five most relevant outcomes, for both an inpatient and outpatient setting.
Results (preliminary): To date 36 (53%) HCPs have completed the second questionnaire. Duration of crying, reduced family stress, sleeping time of the infant and discomfort of the infant were considered to be most important in both outpatient and inpatient setting. In the outpatient setting quality of life was rated as important, and in the inpatient setting reduced hospital admission (and/or duration).
Conclusions: These preliminary results show that there is not much difference in outcome measures that guide treatment decisions in an outpatient and inpatient setting for IC. Furthermore, the results appear to be quite homogeneous across respondents. In a later phase of the project parental views will be taken into account to complete this COS. This COS may enable researchers to standardize the outcomes they measure when setting up a new clinical trial. This will enhance homogeneity and may encourage consensus in the field of IC.