Within-person Change in Patient-reported Outcomes and Their Association With the Wish to Undergo Joint Surgery During a Digital First-line Intervention for Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14,018
- 试验地点
- 1
- 主要终点
- Wish for surgery at 12 months
研究概览
简要总结
Aim To investigate associations between within-person change in patient reported outcomes (PROMs) and wish for joint surgery during up to 12-month participation in a digital first-line intervention for knee and hip osteoarthritis (OA) comprising exercise and education.
Methods Retrospective observational registry data. All participants enrolling between June 1st 2018 and September 30th 2021 with follow-up data and with a change in their wish for surgery (dichotomous, becoming wishing or unwishing) were included. Analysed PROMS comprised pain (numeric rating scale (NRS), 0-10), 5 level EuroQol - 5-dimension (EQ5D-5L, 0.243-0.976), overall health (NRS, 0-10), activity impairment (NRS, 0-10), walking difficulties (yes/no), fear of movement (yes/no), function and quality of life subscales of Knee/Hip injury and Osteoarthritis Outcome Score 12 Items (KOOS-12/HOOS-12, both 0-100). To capture effects of changes in PROMs over time on probability of wish for surgery, the investigators used fixed effect (conditional) logistic regressions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of knee or hip osteoarthritis
- •Date of enrolment between June 1st 2018 and September 30th 2021 (study period)
- •Consent to the use of the data at the moment of enrolment (not withdrawn during the study period)
排除标准
- •No follow-up data
- •No change in wish for surgery (participants remained either wishing or not wishing to undergo surgery for the whole treatment period). This exclusion was due to the focus of the present study on within-person relationships between PROMs and wish for surgery. In this scenario, those with no change in their wish for surgery do not provide any information to the analysis.
结局指标
主要结局
Wish for surgery at 12 months
时间窗: 12 months
Wish for surgery was monitored by asking the participants 'Are your symptoms so severe that you wish to undergo surgery in your \[knee/hip\]?' (dichotomous reply, yes/no).
Wish for surgery at baseline
时间窗: 0 months
Wish for surgery was monitored by asking the participants 'Are your symptoms so severe that you wish to undergo surgery in your \[knee/hip\]?' (dichotomous reply, yes/no).
Wish for surgery at 9 months
时间窗: 9 months
Wish for surgery was monitored by asking the participants 'Are your symptoms so severe that you wish to undergo surgery in your \[knee/hip\]?' (dichotomous reply, yes/no).
Wish for surgery at 3 months
时间窗: 3 months
Wish for surgery was monitored by asking the participants 'Are your symptoms so severe that you wish to undergo surgery in your \[knee/hip\]?' (dichotomous reply, yes/no).
Wish for surgery at 6 months
时间窗: 6 months
Wish for surgery was monitored by asking the participants 'Are your symptoms so severe that you wish to undergo surgery in your \[knee/hip\]?' (dichotomous reply, yes/no).
次要结局
未报告次要终点