Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management.

Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management.
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DOI:
10.1186/1471-2474-15-413
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发表时间:
2014-12-06
影响因子:
2.3
通讯作者:
Dolor RJ
Dolor RJ
中科院分区:
医学3区
文献类型:
--
作者:
Allen KD;Bosworth HB;Chatterjee R;Coffman CJ;Corsino L;Jeffreys AS;Oddone EZ;Stanwyck C;Yancy WS Jr;Dolor RJ

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初级保健中管理骨关节炎 (OA) 的患者和提供者干预措施 (PRIMO) 研究是多站点初级保健网络中针对 OA 的首批卫生服务试验之一。这种多站点方法对于评估干预措施的普遍性非常重要。这些分析描述了 PRIMO 研究诊所的诊所和患者特征以及招募指标的异质性。基线数据来自 PRIMO 研究,该研究招募了来自 10 个杜克初级保健诊所的 537 名患者。通过描述性统计对各个诊所进行了以下项目检查:(1)实践特征,包括初级保健专业、提供者的数量和专业、55岁以上患者的数量、城乡位置和县贫困程度; (2) 招募指标,包括合格率、拒绝率和随机化率; (3) 参与者的特征,包括人口统计和临床数据(一般数据和 OA 相关数据); (4) 参与者自我报告的 OA 治疗使用情况,包括药物和非药物治疗。计算参与者特征和 OA 治疗使用的组内相关系数 (ICC),以描述诊所之间的差异。研究诊所在所有指标上差异很大,其中 55 岁以上患者数量(1,507-5,400 人)、城市/乡村位置(从“农村”到“小城市”)以及贫困线以下的县城家庭比例(12%-26%)存在显着差异。在审查的所有病历中,19% 的患者最初符合资格(各诊所为 10%-31%),其中 17% 被随机纳入研究(各诊所为 13%-21%)。根据 ICC 的测量,以下患者特征和 OA 治疗使用变量存在相当大的临床间差异:年龄(平均:60.4-66.1 岁)、性别(66%-88% 女性)、种族(16%-61% 非白人)、低收入状况(5%-27%)、存在髋关节 OA(26%-68%)、同时存在膝关节和髋关节 OA (23%-61%)、膝骨关节炎 (24%-61%) 和髋关节骨关节炎 (0%-71%) 的物理治疗,以及使用带金属支撑的护膝 (0%-18%)。尽管 PRIMO 研究中心是一个医疗保健系统中一个初级保健实践网络的一部分,但诊所和患者的特征差异很大,骨关节炎治疗的使用也是如此。这种异质性说明了在膝关节和髋关节 OA 试验中纳入多个不同部位的重要性,以增强普遍性并评估现实世界实施的潜力。临床试验注册号:NCT 01435109 本文的在线版本 (doi:10.1186/1471-2474-15-413) 包含补充材料,可供授权用户使用。
The Patient and PRovider Interventions for Managing Osteoarthritis (OA) in Primary Care (PRIMO) study is one of the first health services trials targeting OA in a multi-site, primary care network. This multi-site approach is important for assessing generalizability of the interventions. These analyses describe heterogeneity in clinic and patient characteristics, as well as recruitment metrics, across PRIMO study clinics. Baseline data were obtained from the PRIMO study, which enrolled n = 537 patients from ten Duke Primary Care practices. The following items were examined across clinics with descriptive statistics: (1) Practice Characteristics, including primary care specialty, numbers and specialties of providers, numbers of patients age 55+, urban/rural location and county poverty level; (2) Recruitment Metrics, including rates of eligibility, refusal and randomization; (3) Participants’ Characteristics, including demographic and clinical data (general and OA-related); and (4) Participants’ Self-Reported OA Treatment Use, including pharmacological and non-pharmacological therapies. Intraclass correlation coefficients (ICCs) were computed for participant characteristics and OA treatment use to describe between-clinic variation. Study clinics varied considerably across all measures, with notable differences in numbers of patients age 55+ (1,507-5,400), urban/rural location (ranging from “rural” to “small city”), and proportion of county households below poverty level (12%-26%). Among all medical records reviewed, 19% of patients were initially eligible (10%-31% across clinics), and among these, 17% were randomized into the study (13%-21% across clinics). There was considerable between-clinic variation, as measured by the ICC (>0.01), for the following patient characteristics and OA treatment use variables: age (means: 60.4-66.1 years), gender (66%-88% female), race (16%-61% non-white), low income status (5%-27%), presence of hip OA (26%-68%), presence both knee and hip OA (23%-61%), physical therapy for knee OA (24%-61%) and hip OA (0%-71%), and use of knee brace with metal supports (0%-18%). Although PRIMO study sites were part of one primary care practice network in one health care system, clinic and patient characteristics varied considerably, as did OA treatment use. This heterogeneity illustrates the importance of including multiple, diverse sites in trials for knee and hip OA, to enhance the generalizability and evaluate potential for real-world implementation. Clinical Trial Registration Number: NCT 01435109 The online version of this article (doi:10.1186/1471-2474-15-413) contains supplementary material, which is available to authorized users.
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