Evidence map›Paper›PMID 33648579›Full record

ArticleTrials2021

"Include me if you can"-reasons for low enrollment of pediatric patients in a psychopharmacological trial.

Larissa Niemeyer, Konstantin Mechler, Jan Buitelaar, Sarah Durston, Bram Gooskens, Bob Oranje, Tobias Banaschewski, Ralf W Dittmann, Alexander Häge

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Article
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.

Larissa Niemeyer *Pediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, J 5, 68159, Mannheim, Germany.
Konstantin Mechler *Pediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, J 5, 68159, Mannheim, Germany. konstantin.mechler@zi-mannheim.de.ORCID http://orcid.org/0000-0002-5322-7140
Jan BuitelaarDepartment of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behavior, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
Sarah DurstonDepartment of Psychiatry, University Medical Center Utrecht Brain Center, Utrecht, The Netherlands.
Bram GooskensDepartment of Psychiatry, University Medical Center Utrecht Brain Center, Utrecht, The Netherlands.
Bob OranjeDepartment of Psychiatry, University Medical Center Utrecht Brain Center, Utrecht, The Netherlands.
Tobias BanaschewskiPediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, J 5, 68159, Mannheim, Germany.
Ralf W DittmannPediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, J 5, 68159, Mannheim, Germany.
Alexander HägePediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, J 5, 68159, Mannheim, Germany.

Funding

Seventh Framework Programme 278948
6 · The paper itself

Abstract

backgroundLow recruitment in clinical trials is a common and costly problem which undermines medical research. This study aimed to investigate the challenges faced in recruiting children and adolescents with obsessive-compulsive disorder and autism spectrum disorder for a randomized, double-blind, placebo-controlled clinical trial and to analyze reasons for non-participation. The trial was part of the EU FP7 project TACTICS (Translational Adolescent and Childhood Therapeutic Interventions in Compulsive Syndromes).

methodsDemographic data on pre-screening patients were collected systematically, including documented reasons for non-participation. Findings were grouped according to content, and descriptive statistical analyses of the data were performed.

resultsIn total, n = 173 patients were pre-screened for potential participation in the clinical trial. Of these, only five (2.9%) were eventually enrolled. The main reasons for non-inclusion were as follows: failure to meet all inclusion criteria/meeting one or more of the exclusion criteria (n = 73; 42.2%), no interest in the trial or trials in general (n = 40; 23.1%), and not wanting changes to current therapy/medication (n = 14; 8.1%).

conclusionsThe findings from this study add valuable information to the existing knowledge on reasons for low clinical trial recruitment rates in pediatric psychiatric populations. Low enrollment and high exclusion rates raise the question of whether such selective study populations are representative of clinical patient cohorts. Consequently, the generalizability of the results of such trials may be limited. The present findings will be useful in the development of improved recruitment strategies and may guide future research in establishing the measurement of representativeness to ensure enhanced external validity in psychopharmacological clinical trials in pediatric populations.

trial registrationEudraCT 2014-003080-38 . Registered on 14 July 2014.

Indexed as

Autism Spectrum DisorderObsessive-Compulsive DisorderPatient ParticipationAdolescentChildClinical Trials as TopicDouble-Blind MethodHumansAutistic disorderClinical trialMemantineObsessive-compulsive disorderRecruitment

Identifiers

PMID33648579
PMCPMC7923624

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.