Hospital for Special Surgery, 535 E. 70th St, New York, NY, USA.
Hospital for Special Surgery, 535 E. 70th St, New York, NY, USA; Weill Cornell Medical College, 407 E 61st St, New York, NY, USA.
Spine J. 2020 Mar;20(3):409-416. doi: 10.1016/j.spinee.2019.10.017. Epub 2019 Oct 31.
BACKGROUND CONTEXT: As the focus in spine surgery has shifted from radiographic to patient-centric outcome, patient-reported outcomes measures (PROMs) are becoming increasingly important. They are linked to patient satisfaction, and are used to assess healthcare expenditure, determine compensation and evaluate cost-effectiveness. Thus, PROMs are important to various stakeholders, including patients, physicians, payers, and healthcare institutions. Thus, it is vital to establish methods to interpret and evaluate these outcome measures. PURPOSE: To evaluate the correlation between Neck Disability Index (NDI), Patient Reported Outcome Measurement Information System Physical Function (PROMIS-PF) and Short Form-12 Physical Health Score (SF-12 PHS) in cervical spinal surgery in order to determine the validity of PROMIS-PF in these patients. STUDY DESIGN/SETTING: Retrospective review of prospectively collected data. PATIENT SAMPLE: Consecutive patients who underwent cervical surgery for degenerative spinal pathology with a minimum of 3 months follow-up. OUTCOME MEASURES: Self-reported measures that is, PROMs including NDI, PROMIS-PF, and SF-12 PHS. METHODS: No funding was received for this study. The authors report no relevant conflict of interest. PROM collected preoperatively and at each follow-up were analyzed using Pearson product-moment correlation. RESULTS: Of the 121 patients included, 66 underwent anterior cervical discectomy and fusion, 42 cervical disc replacement, 13 posterior cervical decompression with or without fusion. A statistically significant improvement was achieved in all PROMs by 6 weeks and maintained at 1 year. Furthermore, the percentage of patients achieving an improvement greater than minimum clinically important difference was similar for NDI and PROMIS-PF, particularly at a follow-up of 3 months or more. A statistically significant negative correlation was seen between NDI and PROMIS-PF, which was moderate preoperatively and in the early postoperative period (r=-0.565 to -0.600), and strong at 3 months or longer follow-up (r=-0.622 to -0.705). A statistically significant, negative correlation was also seen between SF-12 PHS and NDI, which was moderate preoperatively and at 6 weeks (r=-0.5551 to -0.566); and strong at all other time-points (r=-0.678 to -0.749). There was a statistically significant positive correlation between SF-12 PHS and PROMIS-PF, which was strong to very-strong at all time-points (r=0.644-0.822), except at 2 weeks (r=0.570). CONCLUSIONS: Although NDI and SF-12 have been used for several years, PROMIS is a new outcome measure that is increasingly being implemented. The results of our study demonstrate the convergent and discriminant validity of PROMIS-PF, supported by the strong correlation between SF-12 PHS and PROMIS-PF at all time-points and the moderate correlation between NDI and PROMIS-PF preoperatively and in the early postoperative period, respectively. Thus, while PROMIS-PF may not be a good surrogate for disease-specific outcome measures, it may extend value as a precise and efficient general health tool.
背景:随着脊柱外科的重点从影像学转移到以患者为中心的结果,患者报告的结果测量(PROMs)变得越来越重要。它们与患者满意度相关,并用于评估医疗保健支出、确定赔偿和评估成本效益。因此,PROMs 对各种利益相关者都很重要,包括患者、医生、支付者和医疗机构。因此,建立解释和评估这些结果测量的方法至关重要。
目的:评估颈椎脊柱手术中 Neck Disability Index(NDI)、患者报告的结果测量信息系统物理功能(PROMIS-PF)和简化 12 项健康调查量表物理健康评分(SF-12 PHS)之间的相关性,以确定 PROMIS-PF 在这些患者中的有效性。
研究设计/设置:前瞻性收集数据的回顾性研究。
患者样本:连续接受颈椎手术治疗退行性脊柱病变的患者,随访时间至少 3 个月。
结果测量:自我报告的措施,即包括 NDI、PROMIS-PF 和 SF-12 PHS 的 PROMs。
方法:本研究未获得任何资金支持。作者报告无相关利益冲突。使用 Pearson 积矩相关分析术前和每次随访时收集的 PROM。
结果:在 121 例患者中,66 例接受了前路颈椎间盘切除术和融合术,42 例接受了颈椎间盘置换术,13 例接受了后路颈椎减压术,无论是否融合。所有 PROM 在 6 周时均取得了显著改善,并在 1 年时保持稳定。此外,在 3 个月或更长时间的随访中,NDI 和 PROMIS-PF 达到最小临床重要差异改善的患者比例相似。NDI 和 PROMIS-PF 之间存在统计学上显著的负相关,术前和术后早期为中度(r=-0.565 至-0.600),3 个月或更长时间的随访时为强(r=-0.622 至-0.705)。SF-12 PHS 和 NDI 之间也存在统计学上显著的负相关,术前和 6 周时为中度(r=-0.5551 至-0.566),而所有其他时间点均为强(r=-0.678 至-0.749)。SF-12 PHS 和 PROMIS-PF 之间存在统计学上显著的正相关,所有时间点均为强至极强相关(r=0.644-0.822),除了 2 周时为 r=0.570。
结论:尽管 NDI 和 SF-12 已经使用了多年,但 PROMIS 是一种新的结果测量方法,正在越来越多地实施。我们的研究结果证明了 PROMIS-PF 的收敛和判别有效性,这得到了 SF-12 PHS 和 PROMIS-PF 在所有时间点之间的强相关性以及 NDI 和 PROMIS-PF 术前和术后早期之间的中度相关性的支持。因此,虽然 PROMIS-PF 可能不是疾病特异性结果测量的良好替代物,但它可能作为一种精确和高效的一般健康工具而具有价值。
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