中文译文：中西医结合心绞痛随机对照试验报告质量的横断面研究。

BACKGROUND AND OBJECTIVE: Integrated traditional Chinese and western medicine (ITCWM), as a representative type of complex intervention, is commonly used for the treatment of angina pectoris (AP) in clinical practice. However, it is unclear whether the details of ITCWM interventions, such as rationale for selection and design, implementation and potential interactions for different therapies, were adequately reported. Therefore, this study aimed to describe the reporting characteristics and quality in randomized controlled trials (RCTs) of AP with ITCWM interventions. METHODS: Through a search of 7 electronic databases, we identified RCTs of AP with ITCWM interventions published in both English and Chinese from 1 Jan 2017 to 6 Aug 2022. The general characteristics of included studies were summarized, further, the quality of reporting was assessed based on three Checklists, including the CONSORT with 36 items (except for one item 1b about abstract), the CONSORT for abstracts (17 items), and a self-designed ITCWM-related checklist (21 items covering rationale and details of interventions, outcome assessment and analysis). The quality of RCTs published in English and Chinese, as well as journals and dissertations were also compared. RESULTS: A total of 451 eligible RCTs were included. For the reporting compliance, the mean score (95% Confidence Interval) of the CONSORT (72 scores in total), CONSORT for abstract (34 scores in total), and ITCWM-related (42 scores in total) checklists was 27.82 (27.44-28.19), 14.17 (13.98-14.37) and 21.06 (20.69-21.43), respectively. More than half items were evaluated as poor quality (reporting rate < 50%) among each Checklist. Moreover, the reporting quality of publications in English journals was higher than that in Chinese journals in terms of the CONSORT items. The reporting of published dissertations was better than that in journal publications regarding both the CONSORT and ITCWM-specific items. CONCLUSION: Although the CONSORT appears to have enhanced the reporting of RCTs in AP, the quality of ITCWM specifics is variable and in need of improvement. Reporting guideline of the ITCWM recommendations should be developed thus to improve their quality.

背景与目的：中西医结合（ITCWM）作为一种代表性的复杂干预措施，常用于临床心绞痛（AP）的治疗。然而，对于 ITCWM 干预措施的细节，如选择和设计的理由、实施以及不同疗法的潜在相互作用等，是否有充分的报告尚不清楚。因此，本研究旨在描述 AP 采用 ITCWM 干预的随机对照试验（RCT）的报告特征和质量。

方法：通过对 7 个电子数据库进行检索，我们筛选出 2017 年 1 月 1 日至 2022 年 8 月 6 日发表的关于 AP 采用 ITCWM 干预的 RCT 研究。总结纳入研究的一般特征，并基于三个清单评估报告质量，包括 CONSORT 36 项（不包括摘要中的 1b 项）、CONSORT 摘要清单（17 项）和自行设计的 ITCWM 相关清单（21 项，涵盖干预措施的理由和细节、结局评估和分析）。比较英文和中文发表的 RCT 质量、期刊和学位论文的质量。

结果：共纳入 451 项符合条件的 RCT。对于报告的依从性，CONSORT（总分 72 分）、CONSORT 摘要（总分 34 分）和 ITCWM 相关（总分 42 分）清单的平均得分（95%置信区间）分别为 27.82（27.44-28.19）、14.17（13.98-14.37）和 21.06（20.69-21.43）。每个清单中超过一半的项目评价为质量差（报告率 < 50%）。此外，英文期刊发表的出版物在 CONSORT 项目方面的报告质量高于中文期刊。在 CONSORT 和 ITCWM 特定项目方面，发表的学位论文的报告质量优于期刊出版物。

结论：尽管 CONSORT 似乎提高了 AP 中 RCT 的报告质量，但 ITCWM 具体内容的质量参差不齐，需要改进。应该制定 ITCWM 建议的报告指南，以提高其质量。