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

Abstract

Background: Incomplete reporting of components of interventions limits uptake of evidence into clinical practice. Aims:To evaluate the completeness of reporting of research and control interventions in randomised trials of upper limb therapies for children with unilateral cerebral palsy. Methods and procedures:Sixty randomized trials were included, encompassing 60 research and 68 control interventions. Using the 12-item Template for Intervention Description and Replication (TIDieR) checklist, two reviewers independently rated intervention and control descriptions.Outcomes and results: When using 50% of studies as the benchmark, five of the 12 TIDieR items for the research intervention, eight of the 12 items for the control intervention and 11 of 12 items for "usual care" interventions were inadequately reported. Procedures used to deliver the research intervention were adequately reported for 63% of studies. Materials were used in 94% of research interventions, yet only 27% provided details to access/replicate materials. Training materials for interventionists were used in 38% of trials, 10 (17%) had procedure manuals, yet only 3 reported details to access materials. The location where the research intervention was provided was detailed in 65% of studies. Reporting of all items was poorer for the control intervention. Conclusions:No study adequately reported all elements on the TIDieR checklist. Details crucial for replication of interventions and interpretation of results were missing. Authors, reviewers, and editors all have a responsibility to improve the quality of intervention reporting in published trials. The TIDieR guide is a potential solution, helping to structure accounts of interventions. What this study adds:This is the first study 3  This is the first study to evaluate the completeness of reporting of intervention components in complex cerebral palsy interventions  This is the first study to rate completeness of reporting of control interventions  This study provides information to increase awareness of editors, reviewers and authors of the importance of complete reporting of intervention components in cerebral palsy rehabilitation.

Replicating group‐based education interventions for the management of type 2 diabetes: a review of intervention reporting

“…The majority of these findings are consistent with previous evaluations of non‐pharmacological interventions using the TIDieR checklist, with all five previous studies reporting that intervention modifications (item 10) and fidelity (items 11 and 12) were most poorly reported . Reporting modifications to the planned intervention can enable readers to judge potential threats to internal and external validity, and may assist clinicians to avoid the same mistakes in practice .…”

“…The TIDieR checklist has the potential to reduce research waste by improving the ability to replicate interventions, enabling clinicians to implement effective interventions due to the availability of adequate information, and could streamline future research . Since its publication in 2014, the TIDieR checklist has been widely used to report on non‐pharmacological interventions at several stages of the research process , including by studies examining exercise‐based cardiac rehabilitation , physiotherapy interventions and upper limb therapies in unilateral cerebral palsy , and by two systematic reviews assessing telehealth‐delivered dietary intervention trials in chronic disease and trials of printed education material interventions, respectively . Two of the previous TIDieR studies found that none of the included studies completely reported all aspects of the interventions according to the TIDieR checklist.…”

“…Since its publication in 2014, the TIDieR checklist has been widely used to report on non‐pharmacological interventions at several stages of the research process , including by studies examining exercise‐based cardiac rehabilitation , physiotherapy interventions and upper limb therapies in unilateral cerebral palsy , and by two systematic reviews assessing telehealth‐delivered dietary intervention trials in chronic disease and trials of printed education material interventions, respectively . Two of the previous TIDieR studies found that none of the included studies completely reported all aspects of the interventions according to the TIDieR checklist. Furthermore, the systematic reviews that assessed telehealth‐delivered dietary interventions and printed education material interventions only had one included study that completely reported every TIDieR checklist item.…”

Inadequate description of placebo and sham controls in a systematic review of recent trials

“…Based on our limited sample, it seems that reporting of placebo components has improved slightly in the last decade. Our study also revealed that adequate reporting of placebo or sham control interventions is poorer than adequate reporting of active interventions …”

“…Our study also revealed that adequate reporting of placebo or sham control interventions is poorer than adequate reporting of active interventions. 22,23…”