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失访是否会导致治疗成功率的高估?来自超过 15000 名患者的脊柱手术登记处的发现。

Does loss to follow-up lead to an overestimation of treatment success? Findings from a spine surgery registry of over 15,000 patients.

机构信息

Department of Teaching, Research and Development, Spine Center Division, Schulthess Klinik, Lengghalde 2, 8008, Zurich, Switzerland.

Department of Spine Surgery and Neurosurgery, Schulthess Klinik, Zurich, Switzerland.

出版信息

Eur Spine J. 2023 Mar;32(3):813-823. doi: 10.1007/s00586-023-07541-7. Epub 2023 Jan 29.

DOI:10.1007/s00586-023-07541-7
PMID:36709245
Abstract

PURPOSE

Patient-reported outcome measures (PROMs) are integral to the assessment of treatment success, but loss to follow-up (attrition) may lead to bias in the results reported. We sought to evaluate the extent, nature and implications of attrition in a long-established, single-centre spine registry.

METHODS

The registry contained the data of 15,264 consecutive spine surgery patients. PROMs included the Core Outcome Measures Index (COMI) and a rating of the Global Treatment Outcome (GTO) and Satisfaction with Care. Baseline characteristics associated with returning a 12-month PROM (= "responder") were analysed (logistic regression). The 3-month outcomes of 12-month responders versus 12-month non-responders were compared (ANOVA and Chi-square).

RESULTS

In total, 14,758/15,264 (97%) patients (60 ± 17y; 46% men) had consented to the use of their registry data for research. Preoperative, 3-month post-operative and 12-month post-operative PROMs were returned by 91, 90 and 86%, respectively. Factors associated with being a 12-month responder included: greater age, born in the country of the study, no private/semi-private insurance, better baseline status (lower COMI score), fewer previous surgeries, less comorbidity and no perioperative medical complications. 12-month non-responders had shown significantly worse outcomes in their 3-month PROMs than had 12-month responders (respectively, 66% vs 80% good GTO ("treatment helped/helped a lot"); 77% vs 88% satisfied/very satisfied; and 49% vs 63% achieved MCIC on COMI).

CONCLUSION

Although attrition in this cohort was relatively low, 12-month non-responders displayed distinctive characteristics and their early outcomes were significantly worse than those of 12-month responders. If loss to follow-up is not addressed, treatment success will likely be overestimated, with erroneously optimistic results being reported.

摘要

目的

患者报告的结局测量(PROMs)是评估治疗成功的重要组成部分,但随访丢失(流失)可能导致报告结果出现偏差。我们旨在评估一个历史悠久的单一中心脊柱登记处中流失的程度、性质和影响。

方法

该登记处包含了 15264 例连续脊柱手术患者的数据。PROMs 包括核心结局测量指数(COMI)和全球治疗结果(GTO)和护理满意度评分。分析了与返回 12 个月 PROM(=“应答者”)相关的基线特征(逻辑回归)。比较了 12 个月应答者与 12 个月未应答者的 3 个月结局(方差分析和卡方检验)。

结果

共有 14758/15264(97%)名患者(60±17 岁;46%为男性)同意将其登记处数据用于研究。分别有 91%、90%和 86%的患者返回了术前、术后 3 个月和术后 12 个月的 PROM。与成为 12 个月应答者相关的因素包括:年龄较大、出生于研究所在国、无私人/半私人保险、基线状态较好(COMI 评分较低)、手术次数较少、合并症较少且无围手术期医疗并发症。12 个月未应答者的 3 个月 PROM 结果明显差于 12 个月应答者(分别为 66%对 80%的 GTO 良好(“治疗有帮助/帮助很大”);77%对 88%的满意度/非常满意;以及 49%对 63%的 COMI 达到 MCIC)。

结论

尽管该队列的流失率相对较低,但 12 个月未应答者表现出独特的特征,他们的早期结局明显差于 12 个月应答者。如果不解决随访丢失问题,治疗成功可能会被高估,从而报告出错误的乐观结果。

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