Change in Patient Reported Outcomes and Wish for Joint Surgery
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
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.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
Skåne
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Malmö、Skåne、スウェーデン
- Joint Academy
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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- Consent to the use of the data at the moment of enrolment (not withdrawn during the study period)
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Wish for surgery at baseline
時間枠：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).
|
0 months
|
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Wish for surgery at 3 months
時間枠：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).
|
3 months
|
|
Wish for surgery at 6 months
時間枠：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).
|
6 months
|
|
Wish for surgery at 9 months
時間枠：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).
|
9 months
|
|
Wish for surgery at 12 months
時間枠：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).
|
12 months
|
協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。