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预测工具在膝关节骨关节炎患者中的使用和手术意愿:一项随机临床试验。

Predictive Tool Use and Willingness for Surgery in Patients With Knee Osteoarthritis: A Randomized Clinical Trial.

机构信息

Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.

Department of Orthopaedic Surgery, St Vincent's Hospital, Melbourne, Victoria, Australia.

出版信息

JAMA Netw Open. 2024 Mar 4;7(3):e240890. doi: 10.1001/jamanetworkopen.2024.0890.

Abstract

IMPORTANCE

Despite the increasing number of tools available to predict the outcomes of total knee arthroplasty (TKA), the effect of these predictive tools on patient decision-making remains uncertain.

OBJECTIVE

To assess the effect of an online predictive tool on patient-reported willingness to undergo TKA.

DESIGN, SETTING, AND PARTICIPANTS: This parallel, double-masked, 2-arm randomized clinical trial compared predictive tool use with treatment as usual (TAU). The study was conducted between June 30, 2022, and July 31, 2023. Participants were followed up for 6 months after enrollment. Participants were recruited from a major Australian private health insurance company and from the surgical waiting list for publicly funded TKA at a tertiary hospital. Eligible participants had unilateral knee osteoarthritis, were contemplating TKA, and had previously tried nonsurgical interventions, such as lifestyle modifications, physiotherapy, and pain medications.

INTERVENTION

The intervention group was provided access to an online predictive tool at the beginning of the study. This tool offered information regarding the likelihood of improvement in quality of life if patients chose to undergo TKA. The predictions were based on the patient's age, sex, and baseline symptoms. Conversely, the control group received TAU without access to the predictive tool.

MAIN OUTCOMES AND MEASURES

The primary outcome measure was the reduction in participants' willingness to undergo surgery at 6 months after tool use as measured by binomial logistic regression. Secondary outcome measures included participant treatment preference and the quality of their decision-making process as measured by the Knee Decision Quality Instrument.

RESULTS

Of 211 randomized participants (mean [SD] age, 65.8 [8.3] years; 118 female [55.9%]), 105 were allocated to the predictive tool group and 106 to the TAU group. After adjusting for baseline differences in willingness for surgery, the predictive tool did not significantly reduce the primary outcome of willingness for surgery at 6 months (adjusted odds ratio, 0.85; 95% CI, 0.42-1.71; P = .64).

CONCLUSIONS AND RELEVANCE

Despite the absence of treatment effect on willingness for TKA, predictive tools might still enhance health outcomes of patients with knee osteoarthritis. Additional research is needed to optimize the design and implementation of predictive tools, address limitations, and fully understand their effect on the decision-making process in TKA.

TRIAL REGISTRATION

ANZCTR.org.au Identifier: ACTRN12622000072718.

摘要

重要性

尽管有越来越多的工具可用于预测全膝关节置换术(TKA)的结果,但这些预测工具对患者决策的影响仍不确定。

目的

评估在线预测工具对患者接受 TKA 的意愿的影响。

设计、设置和参与者:这项平行、双盲、2 臂随机临床试验比较了预测工具的使用与常规治疗(TAU)。该研究于 2022 年 6 月 30 日至 2023 年 7 月 31 日进行。参与者在入组后随访 6 个月。参与者从澳大利亚一家主要的私人医疗保险公司和一家三级医院的公共资金 TKA 手术等候名单中招募。符合条件的参与者患有单侧膝骨关节炎,正在考虑 TKA,并且之前尝试过非手术干预,例如生活方式改变、物理治疗和止痛药物。

干预措施

干预组在研究开始时获得了在线预测工具的使用权。该工具提供了有关患者选择接受 TKA 后生活质量改善可能性的信息。这些预测是基于患者的年龄、性别和基线症状。相比之下,对照组在没有使用预测工具的情况下接受 TAU。

主要结局和测量指标

主要结局测量指标是在工具使用后 6 个月时参与者接受手术意愿的降低,通过二项逻辑回归进行测量。次要结局测量指标包括参与者的治疗偏好和他们的决策过程质量,通过膝关节决策质量工具进行测量。

结果

在 211 名随机参与者中(平均[SD]年龄 65.8[8.3]岁;118 名女性[55.9%]),105 名被分配到预测工具组,106 名被分配到 TAU 组。在调整了手术意愿的基线差异后,预测工具并没有显著降低 6 个月时手术意愿的主要结局(调整后的优势比,0.85;95%CI,0.42-1.71;P=0.64)。

结论和相关性

尽管预测工具对 TKA 的意愿没有治疗效果,但它们仍然可以提高膝关节骨关节炎患者的健康结果。需要进一步研究来优化预测工具的设计和实施,解决其局限性,并充分了解其对 TKA 决策过程的影响。

试验注册

ANZCTR.org.au 标识符:ACTRN12622000072718。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66a5/10924247/698b8ea4a093/jamanetwopen-e240890-g001.jpg

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