背景 隨機對照試驗（randomized controlled trials，RCTs）常用于評估社會和心理干預措施的效果，這些結果亦常被用于制定決策。有關社會及心理干預措施試驗結果的準確、完整和透明的報告，對了解針對這些干預措施的臨床試驗設計、實施、結果及這些結果的應用至關重要。然而，關于社會和心理干預措施的 RCT 報告質量仍不理想。CONSORT（consolidated standards of reporting trials）聲明改善了生物醫學領域 RCT 的報告質量，同樣，行為和社會科學方面也需要類似的高質量報告規范。我們的目標是基于 RCT 報告規范 2010 年聲明（Consolidated Standards of Reporting Trials 2010 Statement，CONSORT 2010）的官方擴展版，制定適用于社會和心理干預措施（social and psychological interventions，SPI）的 RCT 報告規范（CONSORT-SPI 2018）。 方法 我們遵循最佳方案制定報告規范的擴展版。首先，我們對現有報告規范進行了系統評價。隨后，我們進行了有 384 位國際參與者參加的德爾菲在線調查。2014 年 3 月，我們舉行了為期 3 天的共識會議，由 31 位專家參與，確定針對社會和心理干預措施的 RCT 報告的檢查清單內容。專家們仔細討論了先前與社會和心理干預措施 RCT 相關的研究和方法學問題。然后，投票決定對 CONSORT 2010 條目的修改或擴展。 結果 CONSORT-SPI 2018 檢查清單擴展了 CONSORT 2010 的 25 個條目中的 9 個，包括：背景和目標、試驗設計、受試者、干預措施、統計方法、受試者流程、基線數據、結果和估計及資助來源。此外，與會者還添加了一個與利益相關方參與度有關的新條目，此外，也修改了與受試者招募和及其后續維持相關的流程圖。 結論 作者應使用 CONSORT-SPI 2018 來改善社會和心理干預相關的 RCT 的報告質量。期刊應修改編輯政策和程序，要求作者使用報告規范準備相關稿件，要求同行評議者使用報告規范評審相關稿件，以使讀者能夠評估研究的質量，評價研究結果的推廣性，并重復有效的干預措施。
The Standards for reporting diagnostic accuracy studies (STARD) 2015 is a revision of the STARD 2003 on the checklist and flow chart, on the basis of the new evidences of potential bias and applicability, to better guide the application of diagnostic test in clinical practices. Currently, the interpretation and application in China is still based on STARD 2003. This review will describe the application status of the original version and introduce the updated standards for reporting diagnostic accuracy studies.
ObjectiveTo develop a transparency evaluation tool 2.0 of clinical practice guidelines (CPGs) oriented by public trust. MethodsThe Delphi method was employed to score and select the importance and operability of evaluation indicators. The analytic hierarchy process was used to determine the weights of the indicators. And the final evaluation indicator system was determined through expert consensus meeting. ResultsIt constructed two first-level indicators including conflict of interest and formulation process, and six second-level indicators, including guideline developers, reviewers, protocol and registration, evidence production, recommendation formation, and external review. Based on the second-level indicators, a total of 21 third-level indicators were constructed from the perspectives of disclosure and management. The logical structure of the tool is rigorous and harmonious. ConclusionThe CPGs transparency assessment tool 2.0 developed in this study provides measurement standards and an evaluation framework for assessing transparency in CPGs.
ObjectiveTo develop a transparent evaluation tool for the transparency of clinical practice guidelines.MethodsLiterature, books and policy documents related to the transparency of guidelines were retrieved from PubMed, EMbase, Web of Science, WanFang Data and CNKI databases to form a pool of items. After two rounds of Delphi expert consultation, the items were modified and scored to determine whether to be included in the final evaluation system. Expert consensus would determine the organization and evaluation method of the final tool.ResultsA total of 77 references were included, and 399 items related to transparency of guidelines were extracted. The items pool containing 53 items was formed after normalization and de-duplication. After two rounds of Delphi consultation, the evaluation tool for transparency of clinical practice guidelines covering 32 items in 6 areas was formed. The established tool consisted of planning (5 items), personnel selection (6 items), conflict of interest management (6 items), recommendation formation process (8 items), external review process (3 items), and guide reporting process (4 items).ConclusionsThe developed evaluation tool for transparency of clinical practice guidelines can provide a standard for the formulation, evaluation and utilization of guidelines from the perspective of transparency.
背景 研發隨機對照試驗報告規范 CONSORT 聲明旨在幫助生物醫學研究人員透明地報告隨機對照試驗（randomised controlled trials，RCTs）。我們已針對社會和心理干預措施制定了 CONSORT 2010 聲明擴展版（CONSORT-SPI 2018），以幫助行為和社會科學家透明地報告這些研究。 方法 在對現有報告規范進行系統評價之后，我們進行了在線德爾菲流程（Delphi process）以優先考慮從系統評價中確定的 CONSORT-SPI 2018 清單的潛在條目。384 位國際參與者中有 321 位（84%）完成了 2 次調查。然后我們召開了由 31 位科學家、期刊編輯和研究資助者組成的共識會議（2014 年 3 月），最終確定 CONSORT-SPI 2018 檢查清單和流程圖的內容。 結果 CONSORT-SPI 2018 擴展了 CONSORT 2010 檢查清單中的 9 個條目（包括亞條目在內的 14 個條目），增加了一個與利益相關方參與試驗有關的新條目（包括 3 個亞條目），并修改了 CONSORT 2010 流程圖。本解釋與說明（E&E）文件是 CONSORT-SPI 2018 的用戶手冊，可幫助使用者更好地理解 CONSORT-SPI 2018。本文討論了每個清單條目的含義和原理，并提供了完整及明晰的報告示例。 結論 CONSORT-SPI 2018 擴展版、解釋與說明文件及 CONSORT 網站（www.consort-statement.org）是有助于改善社會和心理干預措施 RCTs 報告的有用資源。