TIDieR checklist evaluation of clinical trial intervention reporting for recent FDA-approved anticancer medications

Abstract

ImportanceClear and comprehensive descriptions of clinical trial interventions are necessary to translate new results into clinical practice. The TIDieR checklist was developed to be a minimum set of key items considered essential to high-quality reporting of clinical trial interventions.ObjectiveTo determine the quality of reporting of recent Food and Drug Administration (FDA)-approved oncology interventions.DesignCross-sectional investigation.Setting/Participants/InterventionRecent, FDA-approved haematology/oncology anticancer interventions.Main outcome measureQuality of reporting.ResultsAcross all included trials (n=96), a median of 8–9 (out of 12) TIDieR items were reported. Seven TIDieR items had >90% adherence, including individual-level and study-level modifications of drugs and dosing schedules. Three items were less often reported: intervention provider, including training and expertise (7/192, 3.6%); trial institution infrastructure (0/192, 0.0%); and how intervention compliance was assessed (59/192, 30.7%). Publication of a protocol improved intervention reporting (p<0.001).ConclusionsIn this analysis of clinical trials of recent, FDA-approved anticancer interventions, we found good adherence to the TIDieR checklist. These studies were homogeneous in their structure and included information; some TIDieR items were always or never/rarely reported. Clinical trial effect sizes may not translate to real-world practice for a number of reasons. Thus, to aid the translation of trial effect sizes to real-world practice, we recommend authors adhere to the TIDieR checklist and describe the infrastructure of trial centres and describe who provided the intervention, along with their expertise.

Monitoring, implementation and reporting of interventions in a selection of trials assessing exercise therapy for the management of shoulder subacromial pain: a cross-sectional investigation

“…This scoring system was recommended and used by previous studies for the TIDieR checklist. 27 28 For the TIDieR checklist, we summarised the number of studies that presented a full, partial or no report for each domain. When calculating the scores for NIHBCC checklist, we also calculated the percentage score, defined as the score allocated divided by the total applicable score for each domain, per individual study.…”

“…This approach has been used in previous studies. 27 28 Disparities between reviewers were resolved by consensus. All data extracted were crosschecked by a second reviewer.…”

A multicentric, 2 × 2 factorial, randomised, open-label trial to evaluate the clinical effectiveness of structured physical activity training and cognitive behavioural therapy versus usual care in heart failure patients: a protocol for the PACT-HF trial

“…A dedicated research nurse with experience in managing HF patients and clinical trials will be recruited in each centre to deliver the intervention. A TIDieR check list 22 will be circulated among investigators to describe the nature of the intervention and the role of the study team in delivering the intervention along with their expertise ( Extended data ) 23 , 24 .…”