Evidence map›Paper›PMID 29637094›Full record

ArticleBMJ paediatrics open2017

Development of a core outcome set for clinical trials in childhood constipation: a study using a Delphi technique.

Sophie Kuizenga-Wessel, Nina Francesca Steutel, Marc Alexander Benninga, Thierry Devreker, Elena Scarpato, Annamaria Staiano, Hania Szajewska, Yvan Vandenplas, Merit Monique Tabbers

Abstract read
In one paragraph

Article in BMJ paediatrics open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 10 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  7. Probiotics for treatment of chronic constipation in children.The Cochrane database of systematic reviews · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Sophie Kuizenga-WesselDepartment of Paediatric Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands.
Nina Francesca SteutelDepartment of Paediatric Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands.
Marc Alexander BenningaDepartment of Paediatric Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands.
Thierry DevrekerDepartment of Paediatrics, Free University of Brussels, Brussels, Belgium.
Elena ScarpatoDepartment of Translational Medical Sciences - Section of Paediatrics, University of Naples Federico II, Naples, Italy.
Annamaria StaianoDepartment of Translational Medical Sciences - Section of Paediatrics, University of Naples Federico II, Naples, Italy.
Hania SzajewskaDepartment of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
Yvan VandenplasDepartment of Paediatrics, Free University of Brussels, Brussels, Belgium.
Merit Monique TabbersDepartment of Paediatric Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePatients, their parents and healthcare professionals (HCPs) have a different perception regarding the symptoms of functional constipation (FC). Consequently, a lack of agreement exists on definitions and outcomes used in therapeutic trials of FC. Therefore, our aim was to develop a core outcome set (COS) for FC for children aged 0-1 year and 1-18 years. DESIGN AND

settingProspective study design: primary, secondary and tertiary care settings.

methodsThis COS was developed using a Delphi technique. First, HCPs, parents of children with FC and patients aged ≥12-18 years were asked to list up to five outcomes they considered relevant in the treatment of FC. Outcomes mentioned by >10% of participants were included in a shortlist. In the next phase, outcomes on this shortlist were rated and prioritised by HCPs, parents and patients. Outcomes with the highest scores were included in a draft COS. In a face-to-face expert meeting, the final COS was determined.

resultsThe first phase was completed by 109 HCPs, 165 parents and 50 children. Fifty HCPs, 80 parents and 50 children completed the subsequent phase. The response rate was between 63% and 100% in both steps. The final COS for all ages consisted of: defecation frequency, stool consistency, painful defecation, quality of life, side effects of treatment, faecal incontinence, abdominal pain and school attendance.

conclusionThe use of this COS for FC will decrease study heterogeneity and improve comparability of studies. Therefore, researchers are recommended to use this COS in future therapeutic trials on childhood FC.

Indexed as

functional constipationoutcomes measurespaediatricsparent reported outcomespatient reported outcomes

Identifiers

PMID29637094
PMCPMC5842998

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.