The completeness of intervention descriptions in published National Institute of Health Research HTA-funded trials: a cross-sectional study

Abstract

ObjectivesThe objective of this study was to assess whether National Institute of Health Research (NIHR) Health Technology Assessment (HTA)-funded randomised controlled trials (RCTs) published in the HTA journal were described in sufficient detail to replicate in practice.SettingRCTs published in the HTA journal.Participants98 RCTs published in the HTA journal up to March 2011. Completeness of the intervention description was assessed independently by two researchers using a checklist, which included assessments of participants, intensity, schedule, materials and settings. Disagreements in scoring were discussed in the team; differences were then explored and resolved.Primary and secondary outcome measuresProportion of trials rated as having a complete description of the intervention (primary outcome measure). The proportion of drug trials versus psychological and non-drug trials rated as having a complete description of the intervention (secondary outcome measures).ResultsComponents of the intervention description were missing in 68/98 (69.4%) reports. Baseline characteristics and descriptions of settings had the highest levels of completeness with over 90% of reports complete. Reports were less complete on patient information with 58.2% of the journals having an adequate description. When looking at individual intervention types, drug intervention descriptions were more complete than non-drug interventions with 33.3% and 30.6% levels of completeness, respectively, although this was not significant statistically. Only 27.3% of RCTs with psychological interventions were deemed to be complete, although again these differences were not significant statistically.ConclusionsEnsuring the replicability of study interventions is an essential part of adding value in research. All those publishing clinical trial data need to ensure transparency and completeness in the reporting of interventions to ensure that study interventions can be replicated.

Reporting and Replicating Trials of Exercise-Based Cardiac Rehabilitation

“…As in these previous studies, 4,6,24 we found the intervention setting/location and mode of delivery to be generally well described and descriptions of materials to be consistently lacking. The extent of missing intervention information in our sample, however, appears to be even greater, with the description of many other key components also missing from reports.…”

“…A complete description of this item (Item 8) was missing for almost half (47%) of the interventions in our sample compared with 10% to 25% in previous research. 6,24 This level of missing information was, however, closer to that observed in an examination of exercise interventions for breast cancer survivors, 26 with 34% of included studies failing to report on the intensity, frequency, or length of exercise sessions. Underreporting of these elements is disappointing given that the F.I.T.T principle (frequency, intensity, timing and type), along with the concepts of progression and tailoring captured in Item 9, is well established as a core methodology in exercise prescription.…”

“…Previous studies which used a similar checklist have been able to obtain a comparably greater proportion of complete descriptions of nonpharmacological interventions (39% 6 and 31% 24 ) from published sources. This result may be partly explained by a difference in the checklist used in these earlier studies.…”

“…In previous examinations of the reporting of nonpharmacological interventions, samples have contained <10% of exercise-based trials, and all types of interventions have been analyzed together when assessing completeness. 5,6,24 The specific information needed to provide complete descriptions of items can vary sustainably between different types of nonpharmacological interventions. In particular, the when and how much of exercise-based interventions requires the reporting of several components to provide complete knowledge about this item.…”

Do we really know what they were testing? Incomplete reporting of interventions in randomised trials of upper limb therapies in unilateral cerebral palsy

“…The extent of inadequate reporting of interventions has been investigated in a number of studies, with between 50 to 60 percent of papers missing essential elements in the description of the interventions (Glasziou, Meats, Heneghan, & Shepperd, 2008;Schroter, Glasziou, & Heneghan, 2012). Reporting of nonpharmacological interventions is typically worse than pharmacological interventions (Douet, Milne, Anstee, Habens, Young, & Wright, 2014;Glasziou et al, 2008). In a cross-sectional analysis of 137 non-pharmacological interventions, only 39% were described adequately in the primary paper, protocols or related websites (Hoffmann, Erueti, & Glasziou, 2013).…”