Abstract：
The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.
摘要：
在常规临床实践中，使用患者报告的结果指标（PROM）越来越普遍。作为量化症状和健康状况的工具，PROM在将医疗保健重点放在对患者重要的结果方面发挥着重要作用。PROM数据的用途很多，从临床护理到基于调查的研究和质量改进。识别这些用例之间的界限对于机构审查委员会(IRB)来说可能是一个挑战。在这篇文章中,我们提供了一个框架来分类三个主要的PROM用例(临床护理，人体研究，和质量改进），并讨论每个必要的IRB监督水平（如果有）。IRB工作人员最重要的考虑因素之一是PROM是否主要用于临床护理，因此不构成人类受试者研究。我们讨论了主要为临床护理实施的PROM的特点，重点关注：数据平台；调查位置；问卷长度；患者接口；和临床医生接口。我们还讨论了IRB对涉及在临床护理过程中收集的PROM数据的二次使用的项目的监督，涵盖人类学科研究和质量改进。该框架为IRB工作人员以及在常规临床实践中使用PROM作为沟通辅助工具的临床医生提供了实用指导。
