Medable Inc, Palo Alto, CA, USA.
YPrime, Malvern, PA, USA.
Value Health. 2024 Jan;27(1):79-94. doi: 10.1016/j.jval.2023.10.007. Epub 2023 Oct 23.
While the use of electronic methods to collect patient-reported outcome data in clinical trials continues to increase, it remains the case that many patient-reported outcome measures (PROMs) have originally been developed and validated on paper. Careful consideration during the move from paper PROMs to electronic format is required to preserve the integrity of the measure and ensure a "faithful migration." Relevant literature has long called out the importance of following migration best practices during this process; nevertheless, such best practices are distributed across multiple documents. This article consolidates and builds upon existing electronic PROM implementation best practice recommendations to provide a comprehensive, up-to-date, single point of reference. It reflects the current consensus based on the significant advances in technology capabilities and knowledge gleaned from the growing evidence base on electronic migration and implementation, to balance the need for maintaining the integrity of the measure while optimizing respondent usability. It also specifies whether the practice is rooted in evidence or expert consensus, to enable those using these best practices to make informed and considered decisions when conducting migration.
虽然在临床试验中使用电子方法来收集患者报告的结果数据的情况持续增加，但许多患者报告的结局测量（PROMs）最初是在纸质版上开发和验证的。在从纸质版 PROM 转移到电子版时，需要仔细考虑以保持测量的完整性并确保“忠实迁移”。相关文献长期以来一直强调在这个过程中遵循迁移最佳实践的重要性；然而，这些最佳实践分散在多个文档中。本文整合并建立在现有的电子 PROM 实施最佳实践建议的基础上，提供了一个全面、最新的参考点。它反映了基于技术能力的重大进展和从电子迁移和实施的不断增长的证据基础中获得的知识的当前共识，以平衡保持测量完整性的需求，同时优化受访者的可用性。它还指定了该实践是基于证据还是专家共识，以便使用这些最佳实践的人员在进行迁移时能够做出明智和深思熟虑的决策。
