Intervention reporting of clinical trials published in high-impact cardiology journals: effect of the TIDieR checklist and guide

Palmer, William E.; Okonya, Ochije; Jellison, Samuel; Horn, Jarryd; Harter, Zachery J.; Wilkett, Matt; Vassar, Matt

doi:10.1136/bmjebm-2019-111309

Cited by 15 publications

(14 citation statements)

References 21 publications

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“…Also, within the articles, there was little to no mention of the TIDieR checklist and reporting of interventions in accordance with it, in line with other systematic reviews. Investigating implementation in the cardiovascular medicine literature, Palmer et al 41 found over one-fifth failed to report the dose of the treatment received (item 11). Within behaviour change research similar results to this review have been found, 42 with the maximum dose available always reported, but other elements of dose poorly described.…”

Section: Discussionmentioning

confidence: 99%

“… 41 Therefore, broader dissemination of the TIDieR checklist or incorporating the checklist within item 5 of the CONSORT statement, could improve reporting, as the information would be required by journals for publication. 41 Poor implementation of the TIDieR checklist could also be due to the guidelines being too broad and generic and difficult for authors to adapt to their own interventions. 43 Making the TIDieR checklist clearer and developing customised versions for specific intervention types could increase implementation of the checklist guidelines and ultimately improve intervention description and reporting.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Reporting dose in complex self-management support interventions for long-term conditions: is it defined by researchers and received by participants? A systematic review

Rookes¹,

Barat

Turner

et al. 2022

BMJ Open

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BackgroundThe minimum clinically effective dose, and whether this is received in randomised controlled trials (RCTs) of complex self-management interventions in long-term conditions (LTCs), can be unclear. The Template for Intervention Description and Replication (TIDieR) checklist states that dose should be clearly reported to ensure validity and reliable implementation.ObjectivesTo identify whether the expected minimum clinically effective dose, and the dose participants received is reported within research articles and if reporting has improved since the TIDieR checklist was published.MethodsFour databases were systematically searched (MEDLINE, PsycINFO, AMED and CINAHL) to identify published reports between 2008 and 2022 for RCTs investigating complex self-management interventions in LTCs. Data on reporting of dose were extracted and synthesised from the eligible articles.Results94 articles covering various LTCs including diabetes, stroke and arthritis were included. Most complex interventions involved behaviour change combined with education and/or exercise. The maximum dose was usually reported (n=90; 97.8%), but the expected minimum clinically effective dose and the dose received were reported in only 28 (30.4%) and 62 (67.4%) articles, respectively. Reporting of the expected minimum clinically effective dose and the dose participants received did not improve following the publication of the TIDieR checklist in 2014.ConclusionsInterpreting results and implementing effective complex self-management interventions is difficult when researchers’ reporting of dose is not in line with guidelines. If trial findings indicate benefit from the intervention, clear reporting of dose ensures reliable implementation to standard care. If the results are non-significant, detailed reporting enables better interpretation of results, that is, differentiating between poor implementation and lack of effectiveness. This ensures quality of interventions and validity and generalisability of trial findings. Therefore, wider adoption of reporting the TIDieR checklist dose aspects is strongly recommended. Alternatively, customised guidelines for reporting dose in complex self-management interventions could be developed.PROSPERO registration numberCRD42020180988.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Reporting dose in complex self-management support interventions for long-term conditions: is it defined by researchers and received by participants? A systematic review

Rookes¹,

Barat

Turner

et al. 2022

BMJ Open

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“…This study was conducted in tandem with other studies that evaluated the completeness of intervention reporting across clinical specialties. Since these studies used a common methodology, these methods have also been described elsewhere (12)(13)(14)(15).…”

Section: Methodsmentioning

confidence: 99%

Completeness of Intervention Reporting of Clinical Trials Published in Highly Ranked Obesity Journals

Rauh

Turner

Jellison

et al. 2020

Obesity

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Objective: Randomized controlled trials (RCTs) play a crucial role in the research and advancement of medical treatment. A cross-sectional study design was utilized to analyze the completeness of intervention reporting using the Template for Intervention Description and Replication (TIDieR) checklist and to evaluate factors associated with intervention reporting. A comparison of the completeness of intervention reporting before and after the publication of TIDieR was sought. Methods: PubMed was searched for RCTs in the top 10 obesity journals per the Google h5-index. After excluding non-RCTs, 300 articles were randomly sampled. After assessing each publication for eligibility, two authors (SLR and DT) extracted data related to intervention reporting from records in an independent, masked fashion. Data were then verified and analyzed. Results: The analysis revealed that the quality of intervention reporting is quite variable. Overall, no statistically significant difference in the quality of intervention reporting before and after the release of TIDieR guidelines was found. In general, obesity research has good intervention reporting in areas such as the mode of delivery, material lists for intervention, and procedure lists. However, four main areas in which obesity researchers can improve reporting quality were determined. These include providing the expertise and background of intervention providers and providing statements regarding the assessment of fidelity of the intervention. Conclusions: Urgent intervention is warranted to improve the quality of research reporting in obesity research, which is a fundamental component of obesity management. This will likely require a unified approach from researchers, journals, and funding sources.

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“…In addition, an extension of this guideline focusing only on the interventions section is available - the TIDieR reporting guideline [14]. Among the exercise-based intervention (EBI) CVR studies, about half provide an adequate reporting of interventions [3], without relevant improvement over time regardless of the scientific community effort and editorial policies to improve the quality of reporting of manuscripts [15].…”

Section: Introductionmentioning

confidence: 99%

Assessing the completeness of reporting of exercise-based interventions in cardiovascular trials

Freccia

Santos²,

Lucca³

et al. 2022

Preprint

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Study Objective: In cardiology, the reporting of interventions is insufficiently detailed to elicit replication. Specifically for cardiovascular rehabilitation (CVR) trials, the quality of the description of its exercise-based interventions (EBI) is poorly known. Our primary objective is to estimate the adherence of EBI of CVR trials to TIDieR reporting guideline. Secondarily, we tested whether the CVR setting would be associated with a better reporting, also exploring whether transparency and methodological characteristics could be related. Design and Setting: This cross-sectional study analyzed 96 trials with EBI published within CVR literature. For our primary objective, TIDieR reporting guideline was accounted as a reference to assess overall adherence of eligible RCTs. For our secondary objectives we used generalized estimating equations to point out (a) if intervention setting (eg, home-based vs. centre-based) was associated with intervention reporting, and (b) if trials transparency and methodological characteristics would be associated with intervention reporting. Results: On average, arms adequately reported 4.8/12 (SD=2.4) TIDieR items. 65.07% of our EBI arms failed to adequately report ≥ 6 TIDieR items. Three of 146 (2.05%) arms adhered to all 12 TIDieR items. Additionally, intervention setting was not associated with a better description. Conclusions: We concluded that EBIs in CVR lack to report fundamental aspects of the interventions to be replicated by third parties based on their reports.

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Intervention reporting of clinical trials published in high-impact cardiology journals: effect of the TIDieR checklist and guide

Cited by 15 publications

References 21 publications

Reporting dose in complex self-management support interventions for long-term conditions: is it defined by researchers and received by participants? A systematic review

Reporting dose in complex self-management support interventions for long-term conditions: is it defined by researchers and received by participants? A systematic review

Completeness of Intervention Reporting of Clinical Trials Published in Highly Ranked Obesity Journals

Assessing the completeness of reporting of exercise-based interventions in cardiovascular trials

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