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更新的建议:支持患者报告结局测量中数据收集模式之间测量可比性所需的证据:ISPOR 工作组的良好实践报告。

Updated Recommendations on Evidence Needed to Support Measurement Comparability Among Modes of Data Collection for Patient-Reported Outcome Measures: A Good Practices Report of an ISPOR Task Force.

机构信息

Medidata, London, England, UK.

Division of Clinical Outcome Assessment, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.

出版信息

Value Health. 2023 May;26(5):623-633. doi: 10.1016/j.jval.2023.01.001.

Abstract

The ISPOR Task Force on measurement comparability between modes of data collection for patient-reported outcome measures (PROMs) has updated the good practice recommendations from the 2009 ISPOR electronic patient-reported outcome and 2014 patient-reported outcome mixed modes Good Research Practices Task Force reports in light of accumulated evidence of measurement comparability among different modes of PROM data collection. Furthermore, with the increasing use of electronic formats of clinical outcome assessments in clinical trials and the US Food and Drug Administration's encouragement of electronic data collection, this new task force report provides stakeholders with best practice recommendations reflecting the current body of evidence and enables them to respond to future developments in research and technology. This task force recommends an evidence-based approach to determine whether new research is needed to evaluate measurement comparability for a given questionnaire or technology. The suitability of existing evidence depends upon whether it satisfactorily demonstrates that the change in data collection mode has not affected the PROM's measurement properties. In cases where sufficient evidence of measurement comparability exists and best practices for faithful migration are followed, this task force concludes that further testing of measurement comparability among the data collection modes is unnecessary, including cases of "mixing modes" within clinical trials such as bring your own device designs.

摘要

ISPOR 模式间数据采集用于患者报告结局测量(PROMs)测量可比性工作组更新了 2009 年 ISPOR 电子患者报告结局和 2014 年患者报告结局混合模式良好研究实践工作组报告中的良好实践建议,以反映不同 PROM 数据采集模式之间测量可比性的累积证据。此外,随着电子格式的临床结局评估在临床试验中的应用越来越多,以及美国食品和药物管理局鼓励电子数据采集,本新工作组报告为利益相关者提供了反映当前证据基础的最佳实践建议,并使他们能够应对研究和技术的未来发展。该工作组建议采用基于证据的方法来确定是否需要新的研究来评估特定问卷或技术的测量可比性。现有证据的适用性取决于它是否令人满意地表明数据采集模式的变化没有影响 PROM 的测量特性。在存在足够的测量可比性证据且遵循忠实迁移的最佳实践的情况下,工作组得出结论,不需要进一步测试数据采集模式之间的测量可比性,包括临床试验中“混合模式”的情况,例如自带设备设计。

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