Background
The International Committee of Medical Journal Editors (ICMJE) has promoted the registration of clinical trials to meet the challenge of research transparency, including the ability to adequately address publication bias and selective reporting, and reduce the amount of wasted research
At present, agreement exists on the minimum protocol information that should be registered for a trial, that is, the 20-item World Health Organization (WHO) Trial Registration Data Set
Nevertheless, reporting non-pharmacologic treatments is important but difficult. Non-pharmacologic interventions, such as educational interventions, are usually complex interventions involving several components
The frequency of noncommunicable diseases is increasing, and determining ways to support people with chronic illness is a strong focus of healthcare agendas
We aimed to evaluate the quality of descriptions of interventions assessed in RCTs registered in the WHO International Clinical Trials Registry Platform (ICTRP). We focused on descriptions of the intervention and the context of care in the field of patient education.
Methods
Search strategy
On 6 May 2009, we searched for all ongoing RCTs assessing an educational intervention that were registered in the 10 registries accessible by the WHO search portal
Eligibility criteria
Eligibility criteria were an ongoing randomized clinical trial (recorded as “randomized” or described as randomized in the description of the intervention), evaluating an educational intervention (that is, designed to teach or train patients concerning their own health
Two reviewers independently screened all potentially eligible studies. All disagreements were resolved by consensus and with a third reviewer if necessary.
From the selected records, we randomly chose a sample of 150 records (50%).
Data collection
We developed a data extraction form and two reviewers (CP, IB) independently tested it with a sample of 20 studies. The agreement rate between the reviewers ranged from 0.7 to 1.
Then, a single reviewer (CP) used the standardized data extraction form to collect data from 1) the record in the WHO International Clinical Trials Registry Platform, 2) the record in the primary registry (for example, ClinicalTrials.gov, Netherlands National Trial, Australian New Zealand Clinical Trials Registry (…)) and 3) the website included in the record or previous publications listed in the record. All materials mentioned were searched. We did not search the Internet or write to the investigators for additional data. We collected the following data.
General characteristics
We recorded the primary registry, date of registration, study design, comparator, sample size, number of arms and number of experimental arms. We also noted the type of patients enrolled (healthy or sick), mode of recruitment, age of study participants, and centres involved (country, number of centers, type of center).
To determine the number of participating centers, we used the number of centers reported, if any, in the general description of the trial or the number of centers mentioned in the WHO record; or in the primary registry record in the field “Location” (for ClinicalTrials.gov), “Contact’s address” (for ISRCTN.org and Netherlands National Trial), and “Contact person” (for Australian New Zealand Clinical Trials Registry). We considered that the number was not reported if we could not find at least one result in the fields mentioned above. We classified the trial “unclear multicentric” if the term multicentric was used to describe the trial with no details on the centers involved.
Intervention
We recorded the type of intervention (for example, programmed interaction with a therapist, Web-based program, use of educational material (DVD, booklet) or other type of intervention), and the involvement of other people closely related to the patient in the educational intervention.
We assessed whether items related to the intervention were reported according to the recommendations of the Consort Statement extension for trials of non-pharmacologic treatment
We assessed the reporting of quantitative data, such as the number, frequency and duration of sessions and the course period (that is, the period when participants received the intervention).
If several interventions were assessed, we reported the best-described intervention in the data extraction form.
Statistical analysis
We used descriptive statistics for continuous variables: median [interquartile range], minimum and maximum values. Categorical variables were described with frequencies and percentages. Data analyses involved use of R for Windows, release 2. 9.
Results
Studies selected
Figure
Flow diagram of the selected studies
Flow diagram of the selected studies.
Participants and setting
All selected trials were registered in four registers, mainly ClinicalTrials.gov (60.7%). The median target sample size was 205 [100 to 400] patients. The comparator(s) were mainly usual care (47%) or an active treatment (47%). Of these, most concerned other educational interventions
Study characteristics are summarized in Table
Intervention
Most studies (84%) used programmed interaction (that is, education sessions or phone calls); 30% used educational material (that is, DVD or booklet) and 11% an Internet program (Table
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. For most reports, qualitative data were not reported. For 88 (59%) studies, the content of the educational sessions was not reported. The content was clearly described for 30% (n = 45) of the studies and the description of the content was available in a publication for 28% (n = 42). In total, 11% (n = 17) of reports referenced a website that provided access to educational materials; none of the other 89% of reports provided additional materials.
Information about the care providers administering the intervention was available for 30% (n = 44) of the trials and methods of standardization were specified for 7% (n = 9).
The mode of intervention delivery was reported for 52% (n = 65) of the studies, the number of sessions for 74% (n = 100), the frequency of sessions for 58% (n = 78), the duration of each session for 45% (n = 61) and the overall duration of the intervention for 63% (n = 94) (Tables
Discussion
This study assessed information included in trial registration for a representative random sample of 150 ongoing RCTs assessing an educational intervention, a non-pharmacologic treatment, in the WHO International Clinical Trial Registry Platform. For most trials (59%), interventions were insufficiently described in terms of educational content, modes of delivery and care providers’ qualifications. Most trials (73%) took place in the United States or the United Kingdom, 64% involved only one centre, and participating centres were mainly tertiary-care, academic or university hospitals (51%). The lack of adequate description in such trials raises doubts about the ability of trial registration to help patients and researchers know about the treatment evaluated.
Prospectively registering clinical trials, by placing key protocol information about the trial in the public domain, has been promoted to prevent misconduct in trials, specifically selective reporting
Our findings may be explained in part by the lack of consideration of the specifics of non-pharmacologic interventions in guidelines for trial registration. For example, guidelines for the item dedicated to the intervention in the WHO Trial Registration Data Set are “
Space constraints in both scientific journals and trial registration databases may restrict the full reporting of interventions
However, the complete reporting of items in trial registries raises issues related to intellectual property. Research teams that developed these interventions have invested time and money and are entitled to protect their data before the publication of the study results.
Our results are consistent with those of previous studies investigating the quality of reporting in trial registries
The inferences from this study are limited by the inherent limitations of trial registries. The search strategy may not have identified all studies evaluating educational interventions. Registries have limited advanced search capabilities; contrary to search strategies for databases of published articles, such as MEDLINE or the Cochrane Central Register of Controlled Trials, search strategies of registries have not been evaluated. In addition we did not write to the investigators for clarification.
Conclusions
We show that educational interventions assessed in ongoing RCTs are poorly described in trial registration. The lack of adequate description raises doubt about the ability of trial registration to help patients and researchers know the treatment evaluated.
Abbreviations
ICMJE: International Committee of Medical Journal Editors; WHO: World Health Organization; CONSORT: Consolidation of the standards of reporting trials; RCTs: Randomized controlled trials; ICTRP: International Clinical Trials Registry Platform.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
CP participated in the study concept and design, the literature search and identifying relevant trial records and the acquisition of data from included records; performed the statistical analysis; and participated in the analysis and interpretation of data and drafted the manuscript. IB participated in the study concept and design, the literature search and identifying relevant systematic reviews, the analysis and interpretation of data, the critical revision of the manuscript for important intellectual content and the study supervision. PR participated in the study concept and design, the analysis and interpretation of data and the critical revision of the manuscript for important intellectual content; and supervised the study. CP is guarantor and has full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All authors read and approved the final manuscript.
Funding
This study was funded by a grant “Recherche infirmière – offre de formation doctorat” of the “Assistance Publique - Hôpitaux de Paris”.