验证患者报告结局测量信息系统（PROMIS）在腰椎管狭窄症手术治疗中的计算机自适应测试（CAT）。
Validation of Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Tests (CATs) in the Surgical Treatment of Lumbar Spinal Stenosis.
机构信息
Department of Orthopaedic Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Department of Orthopaedic Surgery, University of Texas - Houston, Houston, Texas.
出版信息
Spine (Phila Pa 1976). 2018 Nov 1;43(21):1521-1528. doi: 10.1097/BRS.0000000000002648.
STUDY DESIGN
Prospective, cohort study.
OBJECTIVE
Demonstrate validity of Patient reported outcomes measurement information system (PROMIS) physical function, pain interference, and pain behavior computer adaptive tests (CATs) in surgically treated lumbar stenosis patients.
SUMMARY OF BACKGROUND DATA
There has been increasing attention given to patient reported outcomes associated with spinal interventions. Historical patient outcome measures have inadequate validation, demonstrate floor/ceiling effects, and infrequently used due to time constraints. PROMIS is an adaptive, responsive National Institutes of Health (NIH) assessment tool that measures patient-reported health status.
METHODS
Ninety-eight consecutive patients were surgically treated for lumbar spinal stenosis and were assessed using PROMIS CATs, Oswestry disability index (ODI), Zurich Claudication Questionnaire (ZCQ), and Short-Form 12 (SF-12). Prior lumbar surgery, history of scoliosis, cancer, trauma, or infection were excluded. Completion time, preoperative assessment, 6 weeks and 3 months postoperative scores were collected.
RESULTS
At baseline, 49%, 79%, and 81% of patients had PROMIS pain behavior (PB), pain interference (PI), and physical function (PF) scores greater than 1 standard deviation (SD) worse than the general population. 50.6% were categorized as severely disabled, crippled, or bed bound by ODI. PROMIS CATs demonstrated convergent validity through moderate to high correlations with legacy measures (r = 0.35-0.73). PROMIS CATs demonstrated known groups validity when stratified by ODI levels of disability. ODI improvements of at least 10 points on average had changes in PROMIS scores in the expected direction (PI = -12.98, PB = -9.74, PF = 7.53). PROMIS CATs demonstrated comparable responsiveness to change when evaluated against legacy measures. PROMIS PB and PI decreased 6.66 and 9.62 and PROMIS PF increased 6.8 points between baseline and 3-months post-op (P < 0.001). Completion time for the PROMIS CATs (2.6 min) compares favorably to ODI, ZCQ, and SF-12 scores (3.1, 3.6, and 3.0 min).
CONCLUSION
PROMIS CATs demonstrate convergent validity, known groups validity, and responsiveness for surgically treated patients with lumbar stenosis to detect change over time and are more efficient than legacy instruments.
LEVEL OF EVIDENCE
研究设计
前瞻性队列研究。
目的
证明患者报告的结局测量信息系统（PROMIS）躯体功能、疼痛干扰和疼痛行为计算机自适应测试（CAT）在接受手术治疗的腰椎狭窄症患者中的有效性。
背景资料概述
人们越来越关注与脊柱干预相关的患者报告结局。历史上的患者结局测量方法验证不足，表现出地板/天花板效应，并且由于时间限制，很少使用。PROMIS 是一种适应性的、反应灵敏的美国国立卫生研究院（NIH）评估工具，用于测量患者报告的健康状况。
方法
98 例连续接受腰椎脊柱狭窄手术治疗的患者使用 PROMIS CATs、Oswestry 残疾指数（ODI）、苏黎世跛行问卷（ZCQ）和简短形式 12 项健康调查（SF-12）进行评估。排除既往腰椎手术、脊柱侧凸、癌症、创伤或感染史。收集术前、术后 6 周和 3 个月的完成时间和评分。
结果
基线时，49%、79%和 81%的患者的 PROMIS 疼痛行为（PB）、疼痛干扰（PI）和躯体功能（PF）评分比一般人群差 1 个标准差（SD）以上。50.6%的患者根据 ODI 被归类为严重残疾、跛行或卧床不起。PROMIS CAT 通过与传统测量方法的中度至高度相关性（r=0.35-0.73）显示出收敛效度。根据 ODI 残疾程度对 PROMIS CAT 进行分层，显示出已知组别的有效性。ODI 平均至少改善 10 分，PROMIS 评分的变化方向符合预期（PI=-12.98，PB=-9.74，PF=7.53）。与传统测量方法相比，PROMIS CAT 在评估变化时表现出相当的反应性。PROMIS PB 和 PI 在基线和术后 3 个月分别下降了 6.66 和 9.62，PROMIS PF 增加了 6.8 分（P<0.001）。PROMIS CAT 的完成时间（2.6 分钟）优于 ODI、ZCQ 和 SF-12 评分（3.1、3.6 和 3.0 分钟）。
结论
PROMIS CAT 为接受腰椎狭窄手术治疗的患者提供了收敛效度、已知组别的有效性和反应性，可用于检测随时间的变化，并且比传统工具更有效。
证据水平
2 级。
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