Quality of reporting in randomized controlled trials of therapeutic cardiovascular medical devices☆

Abstract

Background: Therapeutic medical devices play an important role in the treatment of cardiovascular diseases. The reliability of the randomized controlled trial, which is the best design for assessing treatment effects, largely depends on the information found in published reports. Limited information regarding the quality of reporting about therapeutic medical devices in trials was provided. Method: A cross‐sectional study was conducted to assess the reporting quality of randomized controlled trials that tested the effects of therapeutic cardiovascular medical devices. The quality of reporting was assessed against a modified Consolidated Standards of Reporting Trials checklist, including 47 items from the Consolidated Standards of Reporting Trials statement and Consolidated Standards of Reporting Trials extension. We also examined the specific items regarding medical devices. Univariable and multivariable linear regressions were undertaken to explore potential factors associated with Consolidated Standards of Reporting Trials scores. Result: Some 115 randomized controlled trials were identified. The mean (standard deviation) Consolidated Standards of Reporting Trials score was 20.5 (5.0). The extent of compliance with the Consolidated Standards of Reporting Trials reporting guideline differed substantially across items: 5 of the 47 items were reported adequately across trials (more than 90%), and 10 were reported adequately in less than 5% of trials. Less than 50% of the trials reported additional items related to the medical device. Multivariable regression analysis showed that trials published in general journals (coefficient 7.44, 95% confidence interval [CI]: 5.50–9.38), with larger sample sizes (coefficient 2.30, 95% CI: 0.76–3.83), and multiple‐center studies (coefficient 3.14, 95% CI: 1.27–5.01) were associated with a higher quality of reporting. Conclusion: The overall reporting quality in randomized controlled trials of therapeutic medical device trials is suboptimal, particularly in terms of items regarding surgeons and hospitals. We suggest that the existing Consolidated Standards of Reporting Trials and extension should be modified to be more applicable to therapeutic medical devices.