Abstract：
BACKGROUND: Inadequate reporting of fidelity to interventions in trials limits the transparency and interpretation of trial findings. Despite this, most trials of non-drug, non-surgical interventions lack comprehensive reporting of fidelity. If fidelity is poorly reported, it is unclear which intervention components were tested or implemented within the trial, which also hinders research reproducibility. This protocol describes the development process of a reporting guideline for fidelity of non-drug, non-surgical interventions (ReFiND) in the context of trials.
METHODS: The ReFiND guideline will be developed in six stages. Stage one: a guideline development group has been formed to oversee the guideline methodology. Stage two: a scoping review will be conducted to identify and summarize existing guidance documents on the fidelity of non-drug, non-surgical interventions. Stage three: a Delphi study will be conducted to reach consensus on reporting items. Stage four: a consensus meeting will be held to consolidate the reporting items and discuss the wording and structure of the guideline. Stage five: a guidance statement, an elaboration and explanation document, and a reporting checklist will be developed. Stage six: different strategies will be used to disseminate and implement the ReFiND guideline.
CONCLUSIONS: The ReFiND guideline will provide a set of items developed through international consensus to improve the reporting of intervention fidelity in trials of non-drug, non-surgical interventions. This reporting guideline will enhance transparency and reproducibility in future non-drug, non-surgical intervention research.
METHODS: The ReFiND guideline will be developed in six stages. Stage one: a guideline development group has been formed to oversee the guideline methodology. Stage two: a scoping review will be conducted to identify and summarize existing guidance documents on the fidelity of non-drug, non-surgical interventions. Stage three: a Delphi study will be conducted to reach consensus on reporting items. Stage four: a consensus meeting will be held to consolidate the reporting items and discuss the wording and structure of the guideline. Stage five: a guidance statement, an elaboration and explanation document, and a reporting checklist will be developed. Stage six: different strategies will be used to disseminate and implement the ReFiND guideline.
CONCLUSIONS: The ReFiND guideline will provide a set of items developed through international consensus to improve the reporting of intervention fidelity in trials of non-drug, non-surgical interventions. This reporting guideline will enhance transparency and reproducibility in future non-drug, non-surgical intervention research.
摘要：
背景：对试验干预措施的忠实性报告不足限制了试验结果的透明度和解释。尽管如此,大多数非药物试验，非手术干预缺乏全面的保真度报告.如果保真度报告不佳，尚不清楚在试验中测试或实施了哪些干预组件，这也阻碍了研究的可重复性。该协议描述了非药物保真度报告指南的开发过程，非手术干预（ReFiND）在试验的背景下。
方法：ReFiND指南将分六个阶段制定。第一阶段：成立了一个指南开发小组来监督指南方法。第二阶段：将进行范围界定审查，以确定和总结关于非药物保真度的现有指导文件，非手术干预。第三阶段：将进行Delphi研究，以就报告项目达成共识。第四阶段：将举行一次协商一致会议，以合并报告项目并讨论准则的措词和结构。第五阶段:指导声明，详细阐述和说明文件，并将制定一份报告清单。第六阶段：将使用不同的策略来传播和实施ReFIND指南。
结论：ReFiND指南将提供一系列通过国际共识制定的项目，以改善非药物试验中干预措施的报告保真度，非手术干预。该报告指南将提高未来非药物的透明度和可重复性，非手术干预研究。
方法：ReFiND指南将分六个阶段制定。第一阶段：成立了一个指南开发小组来监督指南方法。第二阶段：将进行范围界定审查，以确定和总结关于非药物保真度的现有指导文件，非手术干预。第三阶段：将进行Delphi研究，以就报告项目达成共识。第四阶段：将举行一次协商一致会议，以合并报告项目并讨论准则的措词和结构。第五阶段:指导声明，详细阐述和说明文件，并将制定一份报告清单。第六阶段：将使用不同的策略来传播和实施ReFIND指南。
结论：ReFiND指南将提供一系列通过国际共识制定的项目，以改善非药物试验中干预措施的报告保真度，非手术干预。该报告指南将提高未来非药物的透明度和可重复性，非手术干预研究。
