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被遗忘的脊柱评分:腰椎融合手术中一种以患者为中心的新型疗效指标的研究方案。

The forgotten spine score: study protocol for a novel patient-centered outcome measure in lumbar spine fusion surgery.

作者信息

Ambrosio Luca, Schol Jordy, Otani Yuto, Petrucci Giorgia, de Rinaldis Elisabetta, Tamagawa Shota, Russo Fabrizio, Papalia Rocco, Sakai Daisuke, Vadalà Gianluca, Denaro Vincenzo

机构信息

Operative Research Unit of Orthopaedic and Trauma Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy.

Research Unit of Orthopaedic and Trauma Surgery, Department of Medicine and Surgery, Università Campus, Bio-Medico di Roma, Rome, Italy.

出版信息

Front Surg. 2025 May 22;12:1547829. doi: 10.3389/fsurg.2025.1547829. eCollection 2025.

Abstract

Lumbar spine fusion (LSF) surgeries have increased due to the rising prevalence of degenerative spine disorders and advancements in surgical techniques. However, the success of these procedures should be evaluated from the patient's perspective, emphasizing the need for effective patient-reported outcome measures (PROMs). Existing PROMs often focus on symptoms and lack specific validation for surgical patients undergoing LSF. Inspired by the Forgotten Joint Score used in joint replacement surgery, here we introduce the Forgotten Spine Score (FSS), a new patient-centered PROM designed to assess the extent to which patients "forget" about the operated spinal segment(s) in their daily lives. This study protocol outlines our approach to develop and validate the FSS as a reliable tool for evaluating outcomes in LSF patients, focusing on their perception of surgery's impact on daily life and well-being. This multi-institutional cross-sectional study will involve a pilot phase to refine the newly designed 18-item FSS survey in Italian and Japanese, followed by a validation phase to assess the adjusted survey in the respective populations. Eligible participants will include adults who have undergone LSF for degenerative disorders at varying follow-up times. The FSS will be administered alongside the Oswestry Disability Index (ODI). Statistical analyses will assess internal consistency, reliability and validity, with significance set at  < 0.05. The survey will be assessed based on its correlation with the ODI, potential for enhanced sensitivity, and overall appreciation among LSF patients. By improving our understanding of patient-centered outcomes, the FSS has the potential to inform clinical decision-making and patient care.

摘要

由于退行性脊柱疾病的患病率上升以及手术技术的进步,腰椎融合术(LSF)手术有所增加。然而,这些手术的成功与否应从患者的角度进行评估,这凸显了有效患者报告结局测量指标(PROMs)的必要性。现有的PROMs通常侧重于症状,并且缺乏对接受LSF手术患者的具体验证。受关节置换手术中使用的遗忘关节评分的启发,在此我们引入遗忘脊柱评分(FSS),这是一种新的以患者为中心的PROM,旨在评估患者在日常生活中“遗忘”手术脊柱节段的程度。本研究方案概述了我们开发和验证FSS作为评估LSF患者结局的可靠工具的方法,重点关注他们对手术对日常生活和幸福感影响的认知。这项多机构横断面研究将包括一个试点阶段,以完善新设计的18项意大利语和日语FSS调查问卷,随后是一个验证阶段,以评估在各自人群中调整后的调查问卷。符合条件的参与者将包括在不同随访时间因退行性疾病接受LSF手术的成年人。FSS将与奥斯威斯残疾指数(ODI)一起使用。统计分析将评估内部一致性、可靠性和有效性,显著性设定为<0.05。该调查问卷将根据其与ODI的相关性、提高敏感性的潜力以及LSF患者的总体评价进行评估。通过增进我们对以患者为中心的结局的理解,FSS有可能为临床决策和患者护理提供参考。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/03b2/12231350/0c4ba4dffc1d/fsurg-12-1547829-g001.jpg

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