Clinical Research and Evaluation Unit, West China Hospital, Sichuan University, Chengdu, China; Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
Surgery. 2019 May;165(5):965-969. doi: 10.1016/j.surg.2018.09.010. Epub 2018 Oct 30.
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.
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.
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.
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.
治疗性医疗器械在心血管疾病的治疗中发挥着重要作用。评估治疗效果的最佳设计——随机对照试验的可靠性在很大程度上取决于已发表报告中的信息。关于试验中治疗性医疗器械报告质量的信息有限。
本研究采用横断面研究方法，评估了评估治疗心血管医疗器械效果的随机对照试验的报告质量。报告质量的评估依据改良后的 CONSORT 清单，其中包含 CONSORT 声明和 CONSORT 扩展的 47 项内容。我们还检查了有关医疗器械的具体项目。采用单变量和多变量线性回归来探讨与 CONSORT 评分相关的潜在因素。
共纳入 115 项随机对照试验。平均（标准差）CONSORT 评分 20.5（5.0）。各条目对 CONSORT 报告指南的遵守程度存在显著差异：5 项条目在所有试验中报告充分（超过 90%），10 项条目在不到 5%的试验中报告充分。不到 50%的试验报告了与医疗器械相关的其他项目。多变量回归分析显示，发表在普通期刊上的试验（系数 7.44，95%置信区间 [CI]：5.50-9.38）、样本量较大的试验（系数 2.30，95%CI：0.76-3.83）和多中心研究（系数 3.14，95%CI：1.27-5.01）与报告质量的提高相关。
治疗性医疗器械随机对照试验的总体报告质量不理想，尤其是关于外科医生和医院的报告质量。我们建议对现有的 CONSORT 及扩展进行修改，使其更适用于治疗性医疗器械。
