Guidance for Reporting Outcomes in Clinical Trials: A Scoping Review Protocol

Introduction: Patients, families, and clinicians rely on published research to help inform treatment decisions. Without complete reporting of the outcomes studied, evidence-based clinical and policy decisions are limited and researchers cannot synthesize, replicate, or build on existing research findings. To facilitate harmonized reporting of outcomes in published trial protocols and reports, a new reporting standard, the Instrument for reporting of Planned Endpoints in Clinical Trials (InsPECT), is under development. As one of the initial steps in the development of InsPECT, a scoping review will identify and synthesize existing guidance on the reporting of trial outcomes.

Methods and analysis: We will apply methods based on the Joanna Briggs Institute scoping review methods manual. Documents that provide explicit guidance on trial outcome reporting will be searched for using: (1) an electronic bibliographic database search; (2) a grey literature search; and (3) solicitation of colleagues for guidance documents using a snowballing approach. Reference and citation list screening will be performed for included documents. Two trained reviewers will complete title and abstract screening. One reviewer and one verifier will independently complete full-text screening and data charting. Discrepancies will be resolved through discussion with a third reviewer. Captured trial outcome reporting guidance will be compared with candidate InsPECT items to support, refute, and refine InsPECT content and to assess the need for the development of additional items. Data analysis will explore common features of guidance and use quantitative measures (e.g., frequencies) to characterize guidance and its sources.

Ethics and dissemination: A paper describing the review findings will be published in a peer-reviewed journal. The results will be used to inform the InsPECT development process, helping to ensure that InsPECT provides an evidence-based tool for standardizing trial outcome reporting.

Registration details: This protocol was registered prospectively with the Open Science Framework (https://osf.io/ktg84/).

引言：患者、家属及临床医生均依赖于已发表的科研成果以辅助治疗决策。然而，若研究结果的报告不完整，基于证据的临床及政策决策将受到限制，研究者亦难以综合、复制或在此基础上构建现有研究成果。为促进已发表临床试验方案及报告中结果报告的统一性，一项新的报告标准——临床试验计划终点报告工具（InsPECT）正在制定中。作为InsPECT开发初期的重要步骤之一，一项范围广泛的研究综述旨在识别并综合现有关于试验结果报告的指导方针。

研究方法与分析：本研究将采用Joanna Briggs研究所范围广泛研究方法手册中的方法。我们将通过以下途径搜寻提供明确试验结果报告指导的文献：（1）电子文献数据库搜索；（2）灰色文献搜索；（3）通过滚雪球法征求同事的指导性文件。对纳入的文献将进行参考文献和引文列表的筛选。两位经过培训的审阅者将完成标题和摘要的筛选。一名审阅者和一名验证者将独立完成全文筛选和数据图表制作。通过与第三位审阅者讨论解决分歧。所捕获的试验结果报告指导将与候选InsPECT项目进行比较，以支持、反驳和精炼InsPECT内容，并评估开发额外项目的必要性。数据分析将探索指导的共通特征，并使用定量指标（例如，频率）来描述指导及其来源。

伦理与传播：将发表一篇描述综述发现的论文于同行评审期刊。研究结果将被用于指导InsPECT的开发过程，以确保InsPECT提供基于证据的工具，用于标准化试验结果报告。

注册详情：本方案已在开放科学框架（https://osf.io/ktg84/）中进行前瞻性注册。