臨床試驗報告規范 CONSORT（Consolidated Standards of Reporting Trials，CONSORT）聲明旨在提高隨機對照試驗（randomized controlled trail，RCT）的報告質量，然而該聲明卻缺少專門關于患者報告結局（patient-reported outcomes，PROs）的指引，而這部分內容恰恰也是臨床試驗經常報告不足的內容。患者報告結局指標數據的缺失影響了臨床試驗結果的價值。本文報告了依據“提高醫療衛生研究的質量和透明度協作網”（EQUATOR Network）所提出的報告規范研發方法學框架制定的臨床試驗報告規范—CONSORT 患者報告結局擴展版（CONSORT PROs）。最終推薦 5 個 CONSORT 患者報告結局清單條目，用于以患者報告結局為主要或關鍵的次要結局指標的隨機對照試驗。這些推薦條目強烈要求：① 在摘要中需明確說明將患者報告結局作為主要或次要結局指標；② 提供針對患者報告結局指標及其相關適用范疇的假設（如是否使用了多維度患者報告結局指標的檢測工具）；③ 提供或引用患者報告結局測量工具效度和信度的證據；④ 明確說明處理缺失數據的統計學方法；⑤ 討論以患者報告結局指標為研究結果指標的特定局限性和結果對其他人群和臨床實踐的影響。本文還提供了相關條目的示例和附有患者報告結局的 CONSORT 流程圖。建議在報告以患者報告結局作為主要結局指標或關鍵的次要結局指標時，以 CONSORT 患者報告結局擴展版與原版的 CONSORT 報告規范相互參考進行報告。改進后的患者報告結局試驗數據將大大促進對隨機對照試驗結果的全面解釋，并較好指導患者的治療。
ObjectivesTo analyze the current methodological and reporting quality of both domestic and overseas clinical practice guidelines on acupuncture, and to provide reference for the development of high quality acupuncture clinical practice guidelines.MethodsGIN, NICE, AHRQ, PubMed, EMbase, AMED, CINAHL, WanFang Data, CNKI, VIP and CBM databases were electronically searched to collect domestic and overseas clinical practice guidelines on acupuncture from inception to September, 2018. Two reviewers independently screened literature, extracted data and evaluated the methodological and reporting quality by using AGREE Ⅱ and RIGHT tools.ResultsA total of 23 acupuncture clinical practice guidelines were included, in which three were developed by foreign institutions, and the remaining 20 guidelines were jointly developed by WHO Western Pacific Region and China Institute of Acupuncture and Moxibustion. Three foreign and two domestic guidelines were selected for evaluation. The AGREE Ⅱ evaluation showed that the domestic guidelines have higher scores in terms of " scope and purpose”, " stakeholder involvement”, " rigor of development”, " applicability” and " clarity of presentation”, while only " editorial independence” is lower. The overall recommendation is stronger than the foreign guidelines. The RIGHT evaluation showed that for three foreign guidelines, the " reported” items accounted for 52.38%, " unreported” items accounted for 38.09%, " partly reported” items accounted for 6.66%%; however, for domestic guidelines, the " reported” accounted for 45.71%, " unreported” items accounted for 40%, and " partly reported” items accounted for 14.28% respectively. Overall, the difference is not significant (SD<10%). Due to the specificity of acupuncture interventions, the use of AGREEⅡ and RIGHT to evaluate acupuncture clinical practice guidelines still had barriers to some extend on its applicability.ConclusionThe methodological and reporting quality of acupuncture clinical practice guidelines are relatively low. It is urgent to further improve the methodological level and reporting standards of the guidelines, and to develop evaluation tools for the acupuncture field guidelines.