The Effectiveness of Using a Clinical Support Tool in Managing Adolescents with Non-Traumatic Knee Pain (MAP-Knee): protocol for a cluster-randomised superiority trial with delayed intervention and embedded realist evaluation

Henrik Riel, Simon Kristoffer Johansen, Erika Maria Andersen, Malene Kjær Bruun, Niels Henrik Bruun, Chris Djurtoft, Simon Doessing, Tina Heyckendorff-Diebold, Per Hölmich, Martin Bach Jensen, Søren Kaalund, Niels-Christian Kaldau, Tommy Frisgaard Oehlenschlaeger, Charlotte Overgaard, Ole Rahbek, Dorthe Brøndum Rasmussen, Susanne Olesen Schaarup, Thomas Sørensen, Louise Lund Holm Thomsen, Michael Skovdal Rathleff
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Abstract

Background Knee pain affects one in three adolescents, which makes it one of the most common pain sites. Guideline recommendations about the clinical selection of patients likely to benefit from interventions are unclear, which leads to treatment heterogeneity and the potential of wasted resources among adolescents with a good prognosis. In contrast, adolescents with a poorer prognosis may not receive sufficient care. A newly developed clinical decision-support tool (The MAP-Knee Tool) intends to support clinicians in engaging with patients and adjusting the clinicians’ evidence-based practices to accommodate patient preferences and treatment needs via a shared decision-making process. The aims of this trial are 1) to investigate the effectiveness of using a clinical decision-support tool (The MAP-Knee Tool) compared with usual care in adolescents with non-traumatic knee pain in reducing pain measured by KOOS-Child Pain after 12 weeks and 2) to investigate how the intervention worked, for whom, why and under which circumstances applying realist evaluation methodology.
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使用临床支持工具管理青少年非创伤性膝关节疼痛(MAP-Knee)的有效性:采用延迟干预和嵌入式现实主义评估的分组随机优越性试验方案
背景 膝关节疼痛影响着三分之一的青少年,是最常见的疼痛部位之一。有关临床选择可能从干预措施中受益的患者的指南建议尚不明确,这导致了治疗的异质性,并有可能在预后良好的青少年中造成资源浪费。相反,预后较差的青少年可能得不到足够的治疗。新开发的临床决策支持工具(MAP-Knee 工具)旨在支持临床医生与患者进行沟通,并通过共同决策过程调整临床医生的循证实践,以适应患者的偏好和治疗需求。本试验的目的是:1)研究在非创伤性膝关节疼痛的青少年患者中,使用临床决策支持工具(MAP-膝关节工具)与常规护理相比,在 12 周后通过 KOOS 儿童疼痛测量法减轻疼痛的效果;2)采用现实主义评估方法,研究干预的效果如何、对谁有效、为什么有效以及在什么情况下有效。
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