背景:为特定的医疗状况选择最适当的患者报告结果(PRO)指标并不简单。这项研究旨在开发一个全面的患者报告结果测量(PROMs)档案,肿瘤学中观察者报告的结局指标(ObsROM)和护理人员报告的结局指标(CROM),并确定其主要特征和目标结局领域。
方法:作为意大利PRO4All项目的一部分,我们通过广泛的在线数据库搜索问卷。我们开发了一个数据提取表格来收集癌症类型的信息,问卷变体,召回期,和评分系统。我们对问卷进行了内容分析,以根据预定义的38项分类法为每个项目分配特定的结果域。
结果:总共386个PROM(n=356),鉴定并描述了ObsROM(n=13)和CROM(n=17);其中,358也在他们的内容进行了分析。47.3%的仪器是癌症类型特异性的,45.1%是一般癌症,7.9%是为普通人群开发的,但也推荐用于肿瘤学。绝大多数(92.2%)是患者报告的。50.3%的召回期是“上周”。每份问卷的平均项目数为22.0(范围:1-130)。7794个项目被分配了一个结果域,最常见的是情绪功能/健康(22%),身体机能(15.7%),一般结局(10.1%)和护理交付(8.9%).
结论:在肿瘤学中,有多种患者和护理人员报告的措施。该档案可以指导研究人员和从业人员选择最合适的措施,并在临床试验中培养以患者为中心的方法,临床实践,和监管活动。
BACKGROUND: Choosing the most adequate measure of patient-reported outcomes (PROs) for a specific medical condition is not straightforward. This study aimed to develop a comprehensive archive of patient-reported outcome measures (PROMs), observer-reported outcome measures (ObsROMs) and caregiver-reported outcome measures (CROMs) in oncology and identify their main characteristics and target outcome domains.
METHODS: As part of the Italian PRO4All Project, we retrieved questionnaires through an extensive search of online databases. We developed a data extraction form to collect information on cancer type, questionnaire variant(s), recall period, and scoring system. We performed a content analysis of the questionnaires to assign each item a specific outcome domain according to a predefined 38-item taxonomy.
RESULTS: A total of 386 PROMs (n = 356), ObsROMs (n = 13) and CROMs (n = 17) were identified and described; of these, 358 were also analyzed in their content. 47.3 % of the instruments were cancer type-specific, 45.1 % were generic for cancer and 7.9 % were developed for the general population but also recommended in oncology. The great majority (92.2 %) were patient-reported. In 50.3 % the recall period was \"last week\". The mean number of items per questionnaire was 22.0 (range: 1-130). 7794 items were assigned an outcome domain, the most frequent being emotional functioning/wellbeing (22 %), physical functioning (15.7 %), general outcomes (10.1 %) and delivery of care (8.9 %).
CONCLUSIONS: There are a variety of patient and caregiver-reported measures in oncology. This archive can guide researchers and practitioners in selecting the most suitable measures and fostering a patient-centered approach in clinical trials, clinical practice, and regulatory activities.