Bispebjerg and Frederiksberg Hospital, The Parker Institute, Frederiksberg, Copenhagen, Denmark
Bispebjerg and Frederiksberg Hospital, The Parker Institute, Frederiksberg, Copenhagen, Denmark.
RMD Open. 2023 Oct;9(4). doi: 10.1136/rmdopen-2023-003414.
To compare illness perception (IP), pain, functional level and health-related quality of life (HR-QoL) between patients with musculoskeletal pain who participate versus those who do not participate in clinical research projects.
Data were collected between 1 January 2019 and 31 December 2021 in patients visiting the Outpatient Osteoarthritis Clinic at Frederiksberg Hospital, Copenhagen, as part of either clinical research or regular treatment. Questionnaires were collected at baseline and after 10-18 months. Major outcome measure was the change from baseline to follow-up in the Brief Pain Inventory - Short Form (BPI-SF) item 'Average pain'. Secondary outcome measures included The Brief Illness Perception Questionnaire (B-IPQ), measured only at baseline, the EuroQol (EQ-5D-3L), the Health Assessment Questionnaire Disability Index and PainDETECT.
1495 patients were included with 358 (24%) categorised as research participants (exposed) and 1137 (76%) being non-participants (unexposed). The baseline B-IPQ item scores were generally more favourable in the exposed group with statistically significant standardised differences (SD) of 0.2-0.3. Similarly, an SD of 0.3 on the EQ-5D-3L score indicated a better HR-QoL in the exposed group. At follow-up, 24% in the exposed group and 27% in the unexposed group, completed the questionnaires. The mean BPI-sf Average pain between-group difference was: -0.01 points (95% CI: -0.6 to 0.6). Similar clinically irrelevant differences were seen in the other outcomes.
Among musculoskeletal pain patients, research participants report more positive IP and better HR-QoL than non-participants. No additional effect of research participation was found in any outcome over time.
NCT03785561.
比较参与和不参与临床研究项目的肌肉骨骼疼痛患者的疾病感知（IP）、疼痛、功能水平和健康相关生活质量（HR-QoL）。
数据收集于 2019 年 1 月 1 日至 2021 年 12 月 31 日期间，在哥本哈根弗雷德里克斯堡医院的门诊骨关节炎诊所就诊的患者中，这些患者参与了临床研究或常规治疗。在基线和 10-18 个月后收集问卷。主要观察指标是从基线到随访时Brief Pain Inventory-Short Form（BPI-SF）项目“平均疼痛”的变化。次要观察指标包括仅在基线时测量的Brief Illness Perception Questionnaire（B-IPQ）、EuroQol（EQ-5D-3L）、健康评估问卷残疾指数和 PainDETECT。
共纳入 1495 例患者，其中 358 例（24%）被归类为研究参与者（暴露组），1137 例（76%）为非参与者（非暴露组）。暴露组的基线 B-IPQ 项目评分通常更为有利，具有统计学意义的标准化差异（SD）为 0.2-0.3。同样，EQ-5D-3L 评分的 SD 为 0.3，表明暴露组的 HR-QoL 更好。在随访时，暴露组中有 24%，非暴露组中有 27%的患者完成了问卷。两组间 BPI-sf 平均疼痛的差异为：-0.01 分（95%置信区间：-0.6 至 0.6）。在其他结局中也观察到类似的无临床意义差异。
在肌肉骨骼疼痛患者中，与非参与者相比，研究参与者报告的疾病感知和健康相关生活质量更为积极。在任何结局中，研究参与在任何时间都没有发现额外的效果。
NCT03785561。
