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Inadequate description of educational interventions in ongoing randomized controlled trials.
Pino C., Boutron I., Ravaud P.
Trials 13, 1 (2012) 63 - http://www.hal.inserm.fr/inserm-00755771
Inadequate description of educational interventions in ongoing randomized controlled trials.
Cécile Pino () 1, Isabelle Boutron1, 2, Philippe Ravaud1, 2
1 :  Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques
INSERM : U738 – Université Paris VII - Paris Diderot
Faculté de médecine Paris 7 16, Rue Henri Huchard 75018 Paris
2 :  CEC - Centre d'Epidémiologie Clinique
Groupe hospitalier Hôtel Dieu – Assistance publique - Hôpitaux de Paris (AP-HP)
1, place du Parvis de Notre Dame 75181 Paris cedex 4
ABSTRACT: BACKGROUND: The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacological interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs) of patient education. METHODS: On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health) and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. RESULTS: We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%). The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47%) or active treatment (47%). A minority of records (17%, 95% CI 11 to 23%) reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention). Further, for most reports (59%), important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63-%. Information about the caregivers was missing for 70% of trials. Most trials (73%) took place in the United States or United Kingdom, 64% involved only one centre, and participating canters were mainly tertiary-care, academic or university hospitals (51%). CONCLUSIONS: Educational interventions assessed in ongoing RCTs of educational interventions are poorly described in trial registries. The lack of adequate description raises doubts about the ability of trial registration to help patients and researchers know about the treatment evaluated in trials of non-pharmacologic treatment.
Sciences du Vivant/Santé publique et épidémiologie

Articles dans des revues avec comité de lecture
Publisher BioMed Central
ISSN 1745-6215 

This study was funded by a grant "Recherche infirmière - offre de formation doctorat" of the "Assistance Publique - Hôpitaux de Paris"
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