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决策辅助工具对膝骨关节炎黑人患者全膝关节置换术可及性的影响:一项随机临床试验

Effect of a Decision Aid on Access to Total Knee Replacement for Black Patients With Osteoarthritis of the Knee: A Randomized Clinical Trial.

作者信息

Ibrahim Said A, Blum Marissa, Lee Gwo-Chin, Mooar Pekka, Medvedeva Elina, Collier Aliya, Richardson Diane

机构信息

Division of General Internal Medicine, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania2Center for Health Equity Research and Promotion, Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania.

Department of Medicine, Temple University School of Medicine, Philadelphia, Pennsylvania.

出版信息

JAMA Surg. 2017 Jan 18;152(1):e164225. doi: 10.1001/jamasurg.2016.4225.

Abstract

IMPORTANCE

Black patients with advanced osteoarthritis (OA) of the knee are significantly less likely than white patients to undergo surgery. No strategies have been proved to improve access to surgery for black patients with end-stage OA of the knee.

OBJECTIVE

To assess whether a decision aid improves access to total knee replacement (TKR) surgery for black patients with OA of the knee.

DESIGN, SETTING, AND PARTICIPANTS: In a randomized clinical trial, 336 eligible participants who self-identified as black and 50 years or older with chronic and frequent knee pain, a Western Ontario McMaster Universities Osteoarthritis Index score of at least 39, and radiographic evidence of OA of the knee were recruited from December 1, 2010, to May 31, 2014, at 3 medical centers. Exclusion criteria were history of major joint replacement, terminal illness, inflammatory arthritis, prosthetic leg, cognitive impairment, lack of a telephone, or contraindications to elective replacement surgery. Data were analyzed on a per-protocol and intention-to-treat (ITT) basis.

EXPOSURE

Access to a decision aid for OA of the knee, a 40-minute video that describes the risks and benefits of TKR surgery.

MAIN OUTCOMES AND MEASURES

Receipt of TKR surgery within 12 months and/or a recommendation for TKR surgery from an orthopedic surgeon within 6 months after the intervention.

RESULTS

Among 336 patients (101 men [30.1%]; 235 women [69.9%]; mean [SD] age, 59.1 [7.2] years) randomized to the intervention or control group, 13 of 168 controls (7.7%) and 25 of 168 intervention patients (14.9%) underwent TKR within 12 months (P = .04). These changes represent a 70% increase in the TKR rate, which increased by 86% (11 of 154 [7.1%] vs 23 of 150 [15.3%]; P = .02) in the per-protocol sample. Twenty-six controls (15.5%) and 34 intervention patients (20.2%) in the ITT analysis received a recommendation for surgery within 6 months (P = .25). The difference in the surgery recommendation rate between the controls (24 of 154 [15.6%]) and the intervention group (31 of 150 [20.7%]) in the per-protocol analysis also was not statistically significant (P = .25). Adjustment for study site yielded similar results: for receipt of TKR at 12 months, adjusted ORs were 2.10 (95% CI, 1.04-4.27) for the ITT analysis and 2.39 (95% CI, 1.12-5.10) for the per-protocol analysis; for recommendation of TKR at 6 months, 1.39 (95% CI, 0.79-2.44) and 1.41 (95% CI, 0.78-2.55).

CONCLUSIONS AND RELEVANCE

A decision aid increased rates of TKR among black patients. However, rates of recommendation for surgery did not differ significantly. A patient-centered counseling and educational intervention may help to address racial variations in the use of TKR for the management of end-stage OA of the knee.

TRIAL REGISTRATION

clinicaltrials.gov Identifer: NCT01851785.

摘要

重要性

患有晚期膝骨关节炎(OA)的黑人患者接受手术的可能性明显低于白人患者。尚无策略被证明可改善患有终末期膝OA的黑人患者获得手术的机会。

目的

评估决策辅助工具是否能改善患有膝OA的黑人患者接受全膝关节置换术(TKR)的机会。

设计、地点和参与者:在一项随机临床试验中,从2010年12月1日至2014年5月31日,在3个医疗中心招募了336名符合条件的参与者,他们自我认定为黑人,年龄在50岁及以上,患有慢性且频繁的膝关节疼痛,西安大略麦克马斯特大学骨关节炎指数评分至少为39,并有膝关节OA的影像学证据。排除标准包括重大关节置换史、晚期疾病、炎性关节炎、假肢、认知障碍、没有电话或存在择期置换手术的禁忌症。数据按符合方案集和意向性分析(ITT)进行分析。

暴露

获得膝OA决策辅助工具,这是一个40分钟的视频,描述了TKR手术的风险和益处。

主要结局和测量指标

在干预后12个月内接受TKR手术和/或在6个月内从骨科医生处获得TKR手术推荐。

结果

在336例随机分为干预组或对照组的患者中(101例男性[30.1%];235例女性[69.9%];平均[标准差]年龄,59.1[7.2]岁),168例对照组中有13例(7.7%)和168例干预组患者中有25例(14.9%)在12个月内接受了TKR手术(P = 0.04)。这些变化代表TKR率增加了70%,在符合方案集样本中增加了86%(154例中的11例[7.1%]对150例中的23例[15.3%];P = 0.02)。在ITT分析中,26例对照组患者(15.5%)和34例干预组患者(20.2%)在6个月内获得了手术推荐(P = 0.25)。在符合方案分析中,对照组(154例中的24例[15.6%])和干预组(150例中的31例[20.7%])之间的手术推荐率差异也无统计学意义(P = 0.25)。对研究地点进行调整后得到类似结果:对于12个月时接受TKR手术,ITT分析的调整后比值比为2.10(95%CI,1.04 - 4.27),符合方案分析为2.39(95%CI,1.12 - 5.10);对于6个月时TKR手术的推荐,分别为1.39(95%CI,0.79 - 2.44)和1.41(95%CI,0.78 - 2.55)。

结论和相关性

决策辅助工具提高了黑人患者的TKR率。然而,手术推荐率差异无统计学意义。以患者为中心的咨询和教育干预可能有助于解决在终末期膝OA的管理中使用TKR方面的种族差异。

试验注册

clinicaltrials.gov标识符:NCT01851785。

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