Reporting of interventions used in cardiothoracic surgery trials: analysis using the Template for Intervention Description and Replication (TIDieR) checklist

To the editor,

Randomized controlled trials (RCTs) are the gold standard for evaluating intervention effectiveness [1] and advancing clinical practice in cardiothoracic surgery. Considering the importance of RCTs in cardiothoracic surgery, it is important that RCTs be reported in a thorough, clear, and complete manner. In this study, we evaluated the completeness of intervention reporting of cardiothoracic surgery RCTs using the Template for Intervention Reporting (TIDieR) checklist [2].

Our sample included trials published before the 2011–2013 and after 2016–2018 publication of the TIDieR checklist from the top 20 cardiothoracic surgery journals as ranked by Google Scholar h5-index. Title/abstract screening, evaluation of TIDieR adherence, and data extraction were performed by two investigators independently.

In 170 analyzed trials, the mean number of TIDieR items reported was 7.4 (SD = 1.2) out of 12. Five items were completely reported > 80% of the time and included (1) a brief description of the intervention, (2) the rationale for intervention, (3) a description of activities/processes used in the intervention, (4) a description of the mode of delivery and if it was provided individually or in a group, and (5) the number of times the intervention was delivered and over what period of time. Three items were reported in fewer than 20% of the trials including (1) whether modifications were made to the intervention, (2) fidelity assessment (planned), and (3) fidelity assessment (reality). Table 1 presents the results per TIDieR item for all analyzed trials. No included trials provided sufficient intervention description to fulfill all 12 TIDieR items.

Table 1 Characteristics of the included studies (N = 170)

Our findings suggest incomplete reporting of RCTs published in cardiothoracic surgery journals. Complete reporting is important to allow for replication of the intervention in future trials, for physicians to implement the intervention into their clinical practice, and for systematic reviewers to have sufficient intervention information to include them for evidence synthesis [3]. The TIDieR checklist was developed to address incomplete reporting. Our results suggest, however, that the publication of TIDieR had no effect on completeness of intervention reporting among trials in our sample. More comprehensive dissemination strategies may be warranted to increase awareness of its existence. Alternatively, TIDieR could be incorporated into the well-established CONSORT guideline, the gold standard for reporting clinical trials. Given that CONSORT has a clear gap in intervention reporting guidance, the addition of TIDieR would contribute positively to the CONSORT items. Tiruvoipati et al. [4] reported that only 7.8% of cardiothoracic trials adequately reported a detailed description of trial setting and location and 26.6% of included trials provided details of the intervention. Findings from our study, coupled with previous investigations, support the need for improved reporting of cardiothoracic surgery trial interventions.