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IDEAL 报告指南:报告外科创新评估的德尔菲共识声明阶段特定建议

The IDEAL Reporting Guidelines: A Delphi Consensus Statement Stage Specific Recommendations for Reporting the Evaluation of Surgical Innovation.

机构信息

University of Oxford, Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford, UK.

Maimonides Medical Center, Department of Surgery, Brooklyn, NY.

出版信息

Ann Surg. 2021 Jan 1;273(1):82-85. doi: 10.1097/SLA.0000000000004180.

Abstract

OBJECTIVE

The aim of this study was to define reporting standards for IDEAL format studies.

BACKGROUND

The IDEAL Framework and Recommendations establish an integrated pathway for evaluation of new surgical techniques and complex therapeutic technologies. However guidance on implementation has been incomplete, and incorrect use is commonly seen. We describe the consensus development of reporting guidelines for the IDEAL stages, and plans for their dissemination and evaluation.

METHODS

Using the EQUATOR Network recommendations, participants with knowledge of IDEAL were surveyed to determine which IDEAL stages needed reporting guidelines. Draft checklists for stages 1, 2a, 2b, and 4 were subsequently developed by 3 researchers (N.B., A.H., P.M.), and revised through a 2-round Delphi consensus process. A final consensus teleconference resolved outstanding disagreements and clarified wording for checklist items.

RESULTS

Sixty-one participants completed the initial survey, a clear majority indicating that new reporting guidelines were needed for IDEAL Stage 1 (69.5%), Stage 2a (78%), Stage 2b (74.6%), and Stage 4 (66%). A proposed set of checklists was modified by survey participants in 2 online Delphi rounds (n = 54 and n = 47, respectively), resulting in a penultimate checklist for each stage. Fourteen expert working group members finalized the checklist items and successfully resolved any outstanding areas without agreement on a consensus call.

CONCLUSIONS

Participants familiar with IDEAL called for reporting guidelines for studies in all IDEAL stages except stage 3. The checklists developed have the potential to improve standards of reporting and thereby advance the quality of research on surgery and complex interventions and technologies, but require further evaluation in use.

摘要

目的

本研究旨在确定 IDEAL 格式研究的报告标准。

背景

IDEAL 框架和建议为新手术技术和复杂治疗技术的评估建立了一个综合途径。然而,实施方面的指导尚不完善,且常见错误用法。我们描述了 IDEAL 各阶段报告指南的共识制定过程,以及其传播和评估计划。

方法

使用 EQUATOR 网络建议,对具有 IDEAL 知识的参与者进行调查,以确定哪些 IDEAL 阶段需要报告指南。随后,由 3 名研究人员(N.B.、A.H.、P.M.)起草了第 1、2a、2b 和 4 阶段的检查表草案,并通过两轮 Delphi 共识过程进行修订。最后一次电话共识会议解决了悬而未决的分歧,并澄清了检查表项目的措辞。

结果

61 名参与者完成了初步调查,绝大多数表示需要为 IDEAL 第 1 阶段(69.5%)、第 2a 阶段(78%)、第 2b 阶段(74.6%)和第 4 阶段(66%)制定新的报告指南。调查参与者在两轮在线 Delphi 中修改了一套拟议的检查表(分别为 n = 54 和 n = 47),为每个阶段生成了一个最终的检查表。14 名专家工作组成员最终确定了检查表项目,并在没有达成共识的情况下成功解决了任何悬而未决的问题。

结论

熟悉 IDEAL 的参与者呼吁为除第 3 阶段以外的所有 IDEAL 阶段的研究制定报告指南。所开发的检查表有可能提高报告标准,从而提高手术和复杂干预及技术研究的质量,但需要在使用中进一步评估。

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