Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University, 125 S 9th St, Suite 1000, Philadelphia, PA, 19107, USA.
Eur Spine J. 2023 Oct;32(10):3333-3351. doi: 10.1007/s00586-023-07896-x. Epub 2023 Aug 29.
PURPOSE: While patient reported outcome measures (PROMs) define value in spine surgery, several values such as minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptom state (PASS) help guide the interpretation of PROMs and identify thresholds of clinical significance. Significant variation exists in reported values and their calculation, so the primary objective of this study was to systematically review the spine surgery literature for metrics of clinical significance derived from PROMs. METHODS: We conducted a query of PubMed/MEDLINE and Scopus databases from inception to January 1, 2023, for studies that derived quantitative metrics (e.g., SCB, MCID, PASS) from PROMs in the setting of spine surgery with minimum 1-year follow-up. Details regarding the specific PROMs were collected including which PROM was measured, whether anchor- or distribution-based methods were utilized, the specific calculations, and the recommended value for a given PROM based on all evaluated calculations. RESULTS: Thirty-seven studies of 21,780 patients were included. The most commonly evaluated PROM-derived value was the MCID (n = 28), followed by PASS (n = 6) and SCB (n = 4). Twenty-one studies only utilized anchor-based calculations, 15 utilized both anchor-based and distribution-based methods, and one only utilized distribution-based calculations. The most commonly evaluated legacy PROMs were the Oswestry Disability Index (ODI) (N = 11, MCID range 4-20) and visual analog scale back pain (N = 5, MCID range 0.5-4.6). All 10 studies that derived SCB or PASS utilized the receiver operating characteristic methods. Among the six studies deriving a PASS value, four only evaluated ODI, identifying PASS ranging from 5 to 22. CONCLUSION: While calculated measures of clinical significance such as MCID, PASS, and SCB exist, significant heterogeneity exists in the current literature. Current shortcomings include a wide variability of reported value thresholds across the literature, and limited applicability to more heterogenous patient populations than the targeted cohorts included in published investigations. Continued investigations that apply these methods to heterogenous, large-scale populations can help increase generalizability and validity of these measures. LEVEL OF EVIDENCE: III.
目的:虽然患者报告的结局测量(PROMs)定义了脊柱手术的价值,但一些值,如最小临床重要差异(MCID)、实质性临床获益(SCB)和患者可接受的症状状态(PASS),有助于指导 PROMs 的解释并确定临床意义的阈值。报告的值及其计算方法存在显著差异,因此本研究的主要目的是系统地回顾脊柱外科文献中源自 PROMs 的临床意义指标。
方法:我们对 PubMed/MEDLINE 和 Scopus 数据库进行了查询,检索时间从建库到 2023 年 1 月 1 日,纳入了至少有 1 年随访的基于脊柱外科、源自 PROMs 的并具有定量指标(如 SCB、MCID、PASS)的研究。收集了有关特定 PROM 的详细信息,包括测量的 PROM 是什么,是否使用了基于锚定或分布的方法,具体的计算方法,以及基于所有评估计算得出的特定 PROM 的推荐值。
结果:纳入了 37 项研究,共 21780 例患者。评估最多的 PROM 衍生值是 MCID(n=28),其次是 PASS(n=6)和 SCB(n=4)。21 项研究仅使用了基于锚定的计算方法,15 项研究同时使用了基于锚定和分布的方法,1 项研究仅使用了基于分布的计算方法。评估最多的传统 PROM 是 Oswestry 残疾指数(ODI)(n=11,MCID 范围为 4-20)和视觉模拟量表腰痛(n=5,MCID 范围为 0.5-4.6)。所有 10 项评估 SCB 或 PASS 的研究都使用了受试者工作特征方法。在确定 PASS 值的 6 项研究中,有 4 项仅评估了 ODI,确定 PASS 值为 5 至 22。
结论:虽然存在 MCID、PASS 和 SCB 等计算得出的临床意义指标,但目前的文献中存在显著的异质性。目前的不足之处包括文献中报告的阈值值差异很大,以及与已发表研究中纳入的目标队列相比,这些方法的适用性有限,适用于更异质的患者群体。继续应用这些方法对异质、大规模人群进行研究,可以帮助提高这些指标的通用性和有效性。
证据水平:III 级。
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