Background:
The registration of clinical trials has been promoted to prevent publication bias and increaseresearch transparency. Despite general agreement about the minimum amount of informationneeded for trial registration, we lack clear guidance on descriptions of non-pharmacologicalinterventions in trial registries. We aimed to evaluate the quality of registry descriptions ofnon-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs) ofpatient education.
Methods:
On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registriesaccessible through the World Health Organization International Clinical Trials RegistryPlatform. We included trials evaluating an educational intervention (that is, designed to teachor train patients about their own health) and dedicated to participants, their family membersor home caregivers. We used a standardized data extraction form to collect data related to thedescription of the experimental intervention, the centers, and the caregivers.
Results:
We selected 268 of 642 potentially eligible studies and appraised a random sample of 150records. 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. Thecomparator 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 (thatis, description that reported the content, mode of delivery, number, frequency, duration ofsessions and overall duration of the intervention). Further, for most reports (59%), importantinformation about the content of the intervention was missing. The description of the mode ofdelivery 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 overallduration 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, andparticipating canters were mainly tertiary-care, academic or university hospitals (51%).
Conclusions:
Educational interventions assessed in ongoing RCTs of educational interventions are poorlydescribed in trial registries. The lack of adequate description raises doubts about the ability oftrial registration to help patients and researchers know about the treatment evaluated in trialsof non-pharmacologic treatment.