Minimal Clinically Important Changes in Digitally Delivered Osteoarthritis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11,708
- 试验地点
- 1
- 主要终点
- Treatment failed (TF)
研究概览
简要总结
To assess minimal clinically important change, cut-offs for treatment failure and patient acceptable symptom state for pain and patient-reported function and quality of life in persons with hip or knee osteoarthritis, participating in digitally delivered first-line education and exercise treatment.
详细描述
Patient-reported outcome measures (PROMs) are consistently recommended as the primary end-point in clinical trials evaluating treatment effects in different medical conditions. For a meaningful interpretation of the PROMs used, three different approaches have been proposed; The Minimal Important Change (MIC), which is the smallest change in scores that represents an important improvement for the patient, i.e., the patient is feeling better, the Patient Acceptable Symptom State (PASS), which represents patients that consider their current status as acceptable, i.e., the patient is feeling good and Treatment Failure (TF), which represents patients that consider their state so unsatisfactory that they think the treatment has failed, all based on relevant anchor questions. Previous research in patients with anterior cruciate ligament (ACL) injury and femoroacetabular impingement reveals that feeling better is not necessarily the same as feeling good and reporting only the MIC (or mean change) may overestimate the results, stressing the need for including different measures of improvement to evaluate treatment effects on PROMs. The MIC, PASS and TF for persons undergoing digital treatment for hip or knee osteoarthritis are not yet determined. In this retrospective register-based study we will define MIC, PASS and TF in pain and patient-reported function and quality of life, using anchor-based questions, for persons participating in digital first-line treatment for hip and knee OA. In addition, we will use these thresholds to establish the proportion of patients reaching MIC and/or PASS or reporting TF, separate for persons with hip and knee OA.
Statistical analysis
For MIC calculations, participants will be categorized as "importantly improved" if they answered "Better an important improvement" or "Somewhat better but enough to be an important improvement" to the anchor questions for KOOS/HOOS and NRS. MIC for an important improvement will then be calculated using the predictive modeling method (MICpred), adjusting for the proportion of improved patients.
The MICpred method will also be used to calculate the post score (i.e., 3, 6, 9 and 12 months) for KOOS/HOOS-scores and NRS-scores for participants that have responded "Yes" to the PASS or TF anchor question, respectively. The proportion of participants reaching the cut-offs of MIC, PASS and TF for the KOOS/HOOS and NRS, will then be calculated separately for participants with knee and hip OA.
Subgroup analyses on the effect of sex, age and baseline symptoms (depending on data distribution to ensure we will have an adequated sample size also in subgroups) on MIC, PASS and TF will also be performed using the MICpred method
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Treatment failed (TF)
时间窗: 3 - 12 months
The following question will be asked (yes/no): If you answered "No" to the previous question, would you consider your current function as being so unsatisfactory that you think the treatment has failed?
Joint pain
时间窗: 3 - 12 months
Joint pain will be measured with the NRS-scale. NRS comprises an 11-point scale where 0 indicates no pain and 10 indicates the worst possible pain during the last week
KOOS/HOOS-12
时间窗: 3-12 months
The Knee injury and Osteoarthritis Outcome Score (KOOS-12)(knee OA) and the Hip injury and Outcome Score (HOOS)(hip OA) will be used for evaluating knee/hip function and quality of life. The KOOS/HOOS-12 are short versions of the original KOOS/HOOS questionnaires and includes 12 items measuring knee/hip pain, physical function and knee/hip-related quality of life. All items are scored from 0-4. The scores will then be normalized to a score from 0-100 for each domain (pain, function and quality of life) as well as a total score of all three domains where 0 indicates extreme problems and 100 indicates no problems.
Patient acceptable symtom state (PASS)
时间窗: 3 - 12 months
The following question will be asked (yes/no); Considering your knee/hip function, do you feel that your current state is satisfactory? You should take all activities during your daily life, sport and recreational activities, your level of pain and other symptoms, and also your knee/hip- related quality of life into account.
MIC
时间窗: 3 - 12 months
The MIC associated with KOOS/HOOS-12/NRS scores will be calculated using domain specific anchor questions; NRS and KOOS/HOOS pain: How is your joint pain now compared with prior to your participation in the treatment? KOOS/HOOS function: How is your ability to perform daily activities now, compared with prior to your participation in the treatment? (sitting, standing, walking, stairs, putting on/taking off socks, household work)? KOOS/HOOS QoL: How is your quality of life in relation to your knee now, compared with prior to your participation in the treatment? (trust in knee, lifestyle, how often you think of your knee)? With the following response option; Better, an important improvement/ Somewhat better but enough to be an important improvement/ Very small change, not enough to be an important improvement/About the same/Very small change, not enough to be an important deterioration/Somewhat worse, but enough to be an important deterioration/Worse, an important deterioration
次要结局
未报告次要终点