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一项用于确定股骨头骨骺滑脱发病率和临床结局的全国多中心前瞻性监测队列及嵌套同意队列研究方案。

A protocol for a nationwide multicentre, prospective surveillance cohort and nested-consented cohort to determine the incidence and clinical outcomes of slipped capital femoral epiphysis.

作者信息

Perry Daniel C, Arch Barbara, Appelbe Duncan, Francis Priya, Spowart Catherine, Knight Marian

机构信息

University of Liverpool, Institute of Translational Medicine, Alder Hey Hospital, Liverpool, UK.

NDORMS, University of Oxford, Kadoorie Centre, John Radcliffe Hospital, Oxford, UK.

出版信息

Bone Jt Open. 2020 Mar 18;1(3):35-40. doi: 10.1302/2633-1462.13.BJO-2020-0002. eCollection 2020 Mar.

Abstract

AIMS

Slipped capital femoral epiphysis (SCFE) is one of the most common hip diseases of adolescence that can cause marked disability, yet there is little robust evidence to guide treatment. Fundamental aspects of the disease, such as frequency, are unknown and consequently the desire of clinicians to undertake robust intervention studies is somewhat prohibited by a lack of fundamental knowledge.

METHODS

The study is an anonymized nationwide comprehensive cohort study with nested consented within the mechanism of the British Orthopaedic Surgery Surveillance (BOSS) Study. All relevant hospitals treating SCFE in England, Scotland, and Wales will contribute anonymized case details. Potential missing cases will be cross-checked against two independent external sources of data (the national administrative data and independent trainee data). Patients will be invited to enrich the data collected by supplementing anonymized case data with patient-reported outcome measures. In line with recommendations of the IDEAL Collaboration, the study will primarily seek to determine incidence, describe case mix and variations in surgical interventions, and explore the relationships between baseline factors (patients and types of interventions) and two-year outcomes.

DISCUSSION

This is the first disease to be investigated using the BOSS Study infrastructure. It provides a robust method to determine the disease frequency, and a large unbiased sample of cases from which treatment strategies can be investigated. It may form the basis for definitive robust intervention studies or, where these are demonstrated not to be feasible, this may be the most robust cohort study.

摘要

目的

股骨头骨骺滑脱(SCFE)是青少年最常见的髋关节疾病之一,可导致显著残疾,但几乎没有有力证据指导治疗。该疾病的一些基本情况,如发病率,尚不清楚,因此临床医生开展有力干预研究的愿望在一定程度上因缺乏基础知识而受阻。

方法

本研究是一项匿名的全国性综合队列研究,嵌套于英国骨科手术监测(BOSS)研究机制中并获得了同意。英格兰、苏格兰和威尔士所有治疗SCFE的相关医院将提供匿名病例详细信息。潜在的漏报病例将与两个独立的外部数据源(国家行政数据和独立实习生数据)进行交叉核对。将邀请患者通过补充患者报告的结局指标来丰富所收集的数据,以补充匿名病例数据。根据理想合作组织的建议,该研究主要旨在确定发病率,描述病例组合和手术干预的差异,并探索基线因素(患者和干预类型)与两年结局之间的关系。

讨论

这是首次利用BOSS研究基础设施进行调查的疾病。它提供了一种确定疾病发病率的有力方法,以及一个可用于研究治疗策略的大型无偏倚病例样本。它可能成为确定性有力干预研究的基础,或者,如果证明这些研究不可行,这可能是最有力的队列研究。

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