Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK.
BMJ Open. 2021 Jun 30;11(6):e045105. doi: 10.1136/bmjopen-2020-045105.
Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.
患者报告结局(PROs)在临床试验中被用于提供有价值的证据,以说明疾病和治疗对患者症状、功能和生活质量的影响。高质量的临床试验 PRO 数据可以为共同决策、监管和经济分析以及卫生政策提供信息。最近的证据表明,过去试验方案中的 PRO 内容往往不完整或不明确,导致研究浪费。为了解决这个问题,制定了基于国际共识的、专门针对 PRO 的指南:标准议定书项目:干预试验建议(SPIRIT)-PRO 扩展。SPIRIT-PRO 扩展是一个包含 16 个项目的清单,旨在提高与 PRO 数据收集相关的临床试验方案的内容和质量,以最大限度地减少研究浪费,并最终更好地为以患者为中心的护理提供信息。本文详细介绍并阐述了(E&E)文件提供了促进理解和促进推荐清单项目采用的信息,包括一个全面的方案模板。对于每个 SPIRIT-PRO 项目,我们提供了详细的描述、一个或多个来自现有试验方案的示例以及该项目重要性的支持性实证证据。我们建议在使用 SPIRIT 2013 和 SPIRIT-PRO 扩展文件的同时使用本文和方案模板,以优化具有 PRO 的试验方案的透明制定和审查。
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