Sand-Svartrud Anne-Lene, Kjeken Ingvild, Skardal Renate Foss, Gjerset Gunhild M, Johnsen Tonje Jossie, Lyken Anne Dorte, Dagfinrud Hanne, Moe Rikke Helene
Health Services Research and Innovation Unit, and Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Sørlandet Rehabilitation Center, Eiken, Norway.
BMC Health Serv Res. 2024 Dec 24;24(1):1648. doi: 10.1186/s12913-024-12103-8.
Data collection through patient-reported outcome measures (PROMs) is essential for the purpose of rehabilitation research and registries. Existing problems with incomplete PROM data may relate to the patient burden and data set length. This study aimed to analyse response patterns and degree of data completeness in systematic outcome assessments conducted within a clinical study in a multidisciplinary rehabilitation setting, comparing completeness of a brief and a longer set of PROMs.
The Norwegian RehabNytte Cohort was developed to monitor patients' long-term benefit of rehabilitation and progress on PROMs. Adults admitted to one of 17 institutions providing mostly inpatient rehabilitation in secondary healthcare were included between January 2019 and March 2020, and followed for one year. For the purpose of the current randomized controlled trial, the Cohort-patients in 16/17 institutions were randomized to complete either a brief or a longer set of PROMs at admission, discharge, and after 3, 6 and 12 months. The brief set comprised the EQ-5D-5L and additional generic PROMs commonly used in rehabilitation settings. The longer data set expanded upon the brief set by including the Patient-Specific Functional Scale and the 29-item version of the PROMIS Profile instruments. Completeness was measured as the extent of present applicable PROM data at each time point. In addition, we assessed response patterns in terms of dropout rates and intermittently missed assessment events. The RehabNytte study is registered under ClinicalTrial.gov (NCT03764982, first posted 05.12.2018).
Of the 2904 patients included, 1455 were assigned to the brief data set and 1449 to the longer data set. The majority of patients were referred to rehabilitation for rheumatic and musculoskeletal diseases (39.3%) or cancer (26.9%). The data set completeness was significantly higher in the brief set compared to the longer (p < 0.001). From admission to 12 months follow-up, differences in completeness between groups ranged from 6.5 to 12.6 percentage points, consistently favouring the brief set. Completeness was highest at admission, reaching 96.8% (95% CI 0.96-0.98) for the brief set and 84.2% (95% CI 0.82-0.86) for the longer set. The lowest completeness was observed at discharge, with 46.0% (95% CI 0.43-0.49) for the brief set and 39.5% (95% CI 0.37-0.42) for the longer one. Discharge was the only time point without automatic reminders to non-responders from the digital data collection system. Patients responding to the longer data set exhibited the highest dropout rates, while degree of intermittent missing data was comparable between groups. In both groups, only one-third of patients provided complete or partly responses at all five time points.
This study demonstrated that a brief set of PROMs achieved higher data completeness compared to a longer set, when used for repeated measurements in a rehabilitation research setting.
通过患者报告结局量表（PROMs）收集数据对于康复研究和登记至关重要。PROM数据不完整的现有问题可能与患者负担和数据集长度有关。本研究旨在分析在多学科康复环境中的一项临床研究中进行的系统结局评估中的应答模式和数据完整性程度，比较一组简短和一组较长的PROMs的完整性。
挪威RehabNytte队列旨在监测患者的长期康复益处和PROMs进展。2019年1月至2020年3月期间，纳入了在17家主要提供二级医疗住院康复服务的机构之一住院的成年人，并随访一年。出于当前随机对照试验的目的，16/17家机构中的队列患者被随机分配在入院、出院时以及3、6和12个月后完成一组简短或一组较长的PROMs。简短组包括EQ-5D-5L和康复环境中常用的其他通用PROMs。较长的数据集在简短组的基础上进行了扩展，纳入了患者特定功能量表和PROMIS Profile工具的29项版本。完整性通过每个时间点现有适用PROM数据的程度来衡量。此外，我们根据脱落率和间歇性错过评估事件评估了应答模式。RehabNytte研究已在ClinicalTrial.gov注册（NCT03764982，首次发布于2018年12月5日）。
在纳入的2904例患者中，1455例被分配到简短数据集，1449例被分配到较长数据集。大多数患者因风湿性和肌肉骨骼疾病（39.3%）或癌症（26.9%）而接受康复治疗。与较长组相比，简短组的数据集完整性显著更高（p<0.001）。从入院到12个月随访，两组之间的完整性差异在6.5至12.6个百分点之间，始终有利于简短组。入院时完整性最高，简短组达到96.8%（95%CI 0.96-0.98），较长组达到84.2%（95%CI 0.82-0.86）。出院时观察到的完整性最低，简短组为46.0%（95%CI 0.43-0.49），较长组为39.5%（95%CI 0.37-0.42）。出院是唯一没有数字数据收集系统自动提醒未应答者的时间点。对较长数据集作出应答的患者脱落率最高，而两组之间的间歇性缺失数据程度相当。在两组中，只有三分之一的患者在所有五个时间点都提供了完整或部分应答。
本研究表明，在康复研究环境中用于重复测量时，一组简短的PROMs比一组较长的PROMs具有更高的数据完整性。
