Evidence map›Paper›PMID 25856170›Full record

ArticlePediatric research2015

Why do children decide not to participate in clinical research: a quantitative and qualitative study.

Irma M Hein, Pieter W Troost, Martine C de Vries, Catherijne A J Knibbe, Johannes B van Goudoever, Ramón J L Lindauer

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Article in Pediatric research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
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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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Irma M HeinDepartment of Child and Adolescent Psychiatry, Academic Medical Center, Amsterdam, The Netherlands.
Pieter W TroostDepartment of Child and Adolescent Psychiatry, Academic Medical Center, Amsterdam, The Netherlands.
Martine C de VriesDepartment of Medical Ethics and Health Law, Leiden University Medical Center, Leiden, The Netherlands.
Catherijne A J KnibbeDepartment of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein, The Netherlands.
Johannes B van Goudoever1] Department of Pediatrics, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands [2] Department of Pediatrics, VU University Medical Center, Amsterdam, The Netherlands.
Ramón J L LindauerDepartment of Child and Adolescent Psychiatry, Academic Medical Center, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMore pediatric drug trials are needed, but although specific pediatric regulations warrant safety, recruitment of children for these trials remains one of the main difficulties. Therefore, we investigated potential determining factors of nonparticipation in clinical research, in order to optimize research participation of children by recommending improved recruitment strategies.

methodsBetween 1 January 2012 and 1 January 2014, we performed a prospective study among161 pediatric patients, aged 6 to 18 y, who were eligible for clinical research. We quantitatively analyzed the association of potential explanatory variables (e.g., age, cognitive development, experience, ethnicity) with nonparticipation and qualitatively analyzed interviews on reasons for nonparticipation.

resultsSixty percent of the children did not participate in the research project on offer (39% decided not to participate, 21% were indecisive). Lower age, less disease experience, and less complex research with lower risk were predictive for not participating. Time constraint and extra burden were expressed as decisive reasons for not participating.

conclusionsStrategies to optimize research participation should be aimed at younger children and their families, who are logistically challenged and unfamiliar with health care and research. Recommendations include informing pediatric patients and their families of the value of research; minimizing logistic burdens; and improving accessibility.

Indexed as

Patient ParticipationPatient SelectionAdolescentAltruismBiomedical ResearchChildChoice BehaviorDecision MakingFemaleHealth Knowledge, Attitudes, PracticeHumansMaleNetherlandsParentsPediatricsResearch Design

Identifiers

PMID25856170

What OpenQuestion holds

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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.