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针对考虑全膝关节置换术患者的决策辅助工具及外科医生偏好报告:一项随机对照试验试点研究

Decision aid for patients considering total knee arthroplasty with preference report for surgeons: a pilot randomized controlled trial.

作者信息

Stacey Dawn, Hawker Gillian, Dervin Geoffrey, Tugwell Peter, Boland Laura, Pomey Marie-Pascale, O'Connor Annette M, Taljaard Monica

机构信息

University of Ottawa, 451 Smyth Road, Ottawa, ON K1H 8M5, Canada.

出版信息

BMC Musculoskelet Disord. 2014 Feb 24;15:54. doi: 10.1186/1471-2474-15-54.

DOI:10.1186/1471-2474-15-54
PMID:24564877
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3937455/
Abstract

BACKGROUND

To evaluate feasibility and potential effectiveness of a patient decision aid (PtDA) for patients and a preference report for surgeons to reduce wait times and improve decision quality in patients with osteoarthritis considering total knee replacement.

METHODS

A prospective two-arm pilot randomized controlled trial. Patients with osteoarthritis were eligible if they understood English and were referred for surgical consultation about an initial total knee arthroplasty at a Canadian orthopaedic joint assessment clinic. Patients were randomized to the PtDA intervention or usual education. The intervention was an osteoarthritis PtDA for patients and a one-page preference report summarizing patients' clinical and decisional data for their surgeon. The main feasibility outcomes were rates of recruitment and questionnaire completion; the preliminary effectiveness outcomes were wait times and decision quality.

RESULTS

Of 180 patients eligible for surgical consultation, 142 (79%) were recruited and randomized to the PtDA intervention (n = 71) or usual education (n = 71). Data collection yielded a 93% questionnaire completion rate with less than 1% missing items. After one year, 13% of patients remained on the surgical wait list. The median time from referral to being off the wait list (censored using survival analysis techniques) was 33.4 weeks for the PtDA group (n = 69, 95% CI: 26.0, 41.4) and 33.0 weeks for usual education (n = 71, 95% CI: 26.1, 39.9). Patients exposed to the PtDA had higher decision quality based on knowledge (71% versus 47%; p < 0.0001) and quality decision being an informed choice that is consistent with their values for option outcomes (56.4% versus 25.0%; p < 0.001).

CONCLUSIONS

Recruitment of patients with osteoarthritis considering surgery and data collection were feasible. As some patients remained on the surgical waiting list after one year, follow-up should be extended to two years. Patients exposed to the PtDA achieved higher decision quality compared to those receiving usual education but there was no difference in wait for surgery.

TRIALS REGISTRATION

ClinicalTrials.Gov NCT00743951.

摘要

背景

评估患者决策辅助工具(PtDA)对患者的可行性和潜在有效性,以及为外科医生提供的偏好报告,以减少骨关节炎患者考虑全膝关节置换时的等待时间并提高决策质量。

方法

一项前瞻性双臂试点随机对照试验。骨关节炎患者若懂英语且被转介至加拿大骨科关节评估诊所进行初次全膝关节置换手术咨询,则符合条件。患者被随机分为PtDA干预组或常规教育组。干预措施是为患者提供骨关节炎PtDA,以及为外科医生提供一份总结患者临床和决策数据的单页偏好报告。主要可行性结果是招募率和问卷完成率;初步有效性结果是等待时间和决策质量。

结果

在180名符合手术咨询条件的患者中,142名(79%)被招募并随机分为PtDA干预组(n = 71)或常规教育组(n = 71)。数据收集的问卷完成率为93%,缺失项目少于1%。一年后,13%的患者仍在手术等待名单上。使用生存分析技术进行删失处理后,PtDA组(n = 69,95% CI:26.0,41.4)从转诊到从等待名单上移除的中位时间为33.4周,常规教育组(n = 71,95% CI:26.1,39.9)为33.0周。基于知识,接受PtDA的患者决策质量更高(71%对47%;p < 0.0001),且高质量决策是基于与他们对选项结果的价值观一致的明智选择(56.4%对25.0%;p < 0.001)。

结论

招募考虑手术的骨关节炎患者并进行数据收集是可行的。由于一年后仍有一些患者在手术等待名单上,随访应延长至两年。与接受常规教育的患者相比,接受PtDA的患者决策质量更高,但手术等待时间没有差异。

试验注册

ClinicalTrials.Gov NCT00743951。

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