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电子 PROMs 的使用在脊柱手术注册研究中提供了与纸质版相同的结果。一项前瞻性队列研究的结果。

The use of electronic PROMs provides same outcomes as paper version in a spine surgery registry. Results from a prospective cohort study.

机构信息

IRCCS Istituto Ortopedico Galeazzi, Milano, Italy.

Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.

出版信息

Eur Spine J. 2021 Sep;30(9):2645-2653. doi: 10.1007/s00586-021-06834-z. Epub 2021 May 10.

DOI:10.1007/s00586-021-06834-z
PMID:33970326
Abstract

BACKGROUND AND PURPOSE

Patient-Reported Measured Outcomes (PROMs) are essential to gain a full understanding of a patient's condition, and in spine surgery, these questionnaires are of help when tailoring a surgical strategy. Electronic registries allow for a systematic collection and storage of PROMs, making them readily available for clinical and research purposes. This study aimed to investigate the reliability between the electronic and paper form of ODI (Oswestry Disability Index), SF-36 (Short Form Health Survey 36) and COMI-back (Core Outcome Measures Index for the back) questionnaires.

METHODS

A prospective analysis was performed of ODI, SF-36 and COMI-back questionnaires collected in paper and electronic format in two patients' groups: Pre-Operatively (PO) or at follow-up (FU). All patients, in both groups, completed the three questionnaires in paper and electronic form. The correlation between both methods was assessed with the Intraclass Correlation Coefficients (ICC).

RESULTS

The data from 100 non-consecutive, volunteer patients with a mean age of 55.6 ± 15.0 years were analysed. For all of the three PROMs, the reliability between paper and electronic questionnaires results was excellent (ICC: ODI = 0.96; COMI = 0.98; SF36-MCS = 0.98; SF36-PCS = 0.98. For all p < 0.001).

CONCLUSIONS

This study proved an excellent reliability between the electronic and paper versions of ODI, SF-36 and COMI-back questionnaires collected using a spine registry. This validation paves the way for stronger widespread use of electronic PROMs. They offer numerous advantages in terms of accessibility, storage, and data analysis compared to paper questionnaires.

摘要

背景与目的

患者报告的测量结果(PROMs)对于全面了解患者的病情至关重要,在脊柱外科中,这些问卷在制定手术策略时很有帮助。电子登记册允许系统地收集和存储 PROMs,使其便于临床和研究使用。本研究旨在调查 ODI(Oswestry 残疾指数)、SF-36(健康调查 36 短表)和 COMI-back(背部核心结局测量指标)问卷的电子和纸质形式之间的可靠性。

方法

对术前(PO)或随访时(FU)收集的纸质和电子格式的 ODI、SF-36 和 COMI-back 问卷进行前瞻性分析。两组患者均以纸质和电子形式完成了这三个问卷。使用组内相关系数(ICC)评估两种方法之间的相关性。

结果

分析了 100 名非连续、志愿患者的数据,平均年龄为 55.6±15.0 岁。对于所有三种 PROMs,纸质和电子问卷结果之间的可靠性均为极好(ICC:ODI=0.96;COMI=0.98;SF36-MCS=0.98;SF36-PCS=0.98。所有 p<0.001)。

结论

本研究证明了使用脊柱登记处收集的 ODI、SF-36 和 COMI-back 问卷的电子和纸质版本之间具有极好的可靠性。这种验证为更广泛地使用电子 PROMs 铺平了道路。与纸质问卷相比,它们在可及性、存储和数据分析方面具有许多优势。

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