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马里兰骨科注册中心(MOR):前瞻性注册中心的设计与基线特征

The Maryland Orthopaedic Registry (MOR): Design and baseline characteristics of a prospective registry.

作者信息

Henn R Frank, Dubina Andrew G, Jauregui Julio J, Smuda Michael P, Tracy J Kathleen

机构信息

Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, MD, United States.

Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, United States.

出版信息

J Clin Orthop Trauma. 2017 Oct-Dec;8(4):301-307. doi: 10.1016/j.jcot.2017.04.003. Epub 2017 Apr 22.

Abstract

BACKGROUND

Utilization of patient-reported outcome tools allows a more accurate assessment of the efficacy of treatment, which is critical to comparative effectiveness research.

OBJECTIVES

The Maryland Orthopaedic Registry (MOR) was established to assess post-surgical outcomes related to patients' pain, functional status, met expectations, and satisfaction using an electronic data collection system. Secondary aims of the registry include assessment of patient expectations of treatment, activity level, and general health status.

METHODS

Adult patients enrolled in this prospective observational study completed self-report measures assessing pre-operative pain, function, treatment expectations, and activity levels during the perioperative period. MOR utilizes the Patient-Reported Outcomes Measurement Information System (PROMIS)'computer adaptive testing for physical function, pain interference, fatigue, social satisfaction, anxiety, and depression. Perioperative data is extracted from the medical record.

RESULTS

300 patients (40% of eligible) have been enrolled into the initial cohort. Most patients (94.1%) were aged 18-65, and 57% were male. Fifty-seven percent of enrollees were White, 33% Black, and 4% Asian. PROMIS physical function and social satisfaction were both more than half a standard deviation below the population mean. Participants reported PROMIS anxiety scores that were half a standard deviation above the population mean and pain interference scores that were more than a standard deviation above the mean. Physical function scores were significantly worse among participants with lower extremity orthopaedic issues, but scores on other measures were similar between participants undergoing lower or upper extremity surgery.

CONCLUSIONS

MOR provides a comprehensive assessment of patients undergoing orthopaedic surgery. The utilization of electronic clinical assessment tools as well as computer adaptive testing allows for time-efficient data collection. The diverse population is a particular strength of MOR.

摘要

背景

使用患者报告结局工具能够更准确地评估治疗效果,这对比较效果研究至关重要。

目的

建立马里兰骨科注册中心(MOR),使用电子数据收集系统评估与患者疼痛、功能状态、达到预期情况和满意度相关的术后结局。该注册中心的次要目标包括评估患者的治疗期望、活动水平和总体健康状况。

方法

参与这项前瞻性观察性研究的成年患者完成了自我报告测量,评估围手术期的术前疼痛、功能、治疗期望和活动水平。MOR利用患者报告结局测量信息系统(PROMIS)的计算机自适应测试来评估身体功能、疼痛干扰、疲劳、社会满意度、焦虑和抑郁。围手术期数据从病历中提取。

结果

300名患者(占符合条件者的40%)被纳入初始队列。大多数患者(94.1%)年龄在18至65岁之间,57%为男性。57%的登记者为白人,33%为黑人,4%为亚洲人。PROMIS身体功能和社会满意度均比总体均值低超过半个标准差。参与者报告的PROMIS焦虑得分比总体均值高半个标准差,疼痛干扰得分比均值高超过一个标准差。下肢骨科问题患者的身体功能得分明显更差,但下肢或上肢手术参与者在其他测量指标上的得分相似。

结论

MOR对接受骨科手术的患者进行了全面评估。电子临床评估工具以及计算机自适应测试的使用实现了高效的数据收集。多样化的人群是MOR的一个特别优势。

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