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前瞻性诊断准确性研究:一般实践中成人眩晕患者的问诊和体格检查:研究方案。

Prospective diagnostic accuracy study of history taking and physical examination for adults with vertigo in general practice: study protocol.

机构信息

Department of General Practice, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands.

Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.

出版信息

BMJ Open. 2024 Apr 2;14(4):e085715. doi: 10.1136/bmjopen-2024-085715.

Abstract

INTRODUCTION

Vertigo is a prevalent and burdensome symptom. More than 80% of patients with vertigo are primarily treated by their general practitioner (GP) and are never referred to a medical specialist. Despite this therapeutic responsibility, the GP's diagnostic toolkit has serious limitations. All recommended tests lack empirical evidence, because a diagnostic accuracy study on vestibular disorders ('How well does test x discriminate between patients with or without target condition y?') has never been performed in general practice. The VERtigo DIagnosis study aims to fill this gap.

METHODS AND ANALYSIS

We will perform a diagnostic accuracy study on vertigo of primary vestibular origin in general practice to assess the discriminative ability of history taking and physical examination. We will compare all index tests with a respective reference standard. We will focus on five target conditions that account for more than 95% of vertigo diagnoses in general practice: (1) benign paroxysmal positional vertigo, (2) vestibular neuritis, (3) Ménière's disease, (4) vestibular migraine (VM) and (5) central causes other than VM. As these five target conditions have a different pathophysiology and lack one generally accepted gold standard, we will use consensus diagnosis as a construct reference standard. Data for each patient, including history, physical examination and additional tests as recommended by experts in an international Delphi procedure, will be recorded on a standardised form and independently reviewed by a neurologist and otorhinolaryngologist. For each patient, the reviewers have to decide about the presence/absence of each target condition. We will calculate sensitivity, specificity, predictive values, likelihood ratios and diagnostic ORs, followed by decision rules for each target condition.

ETHICS AND DISSEMINATION

The study obtained approval from the Vrije Universiteit Medical Center Medical Ethical Review Committee (reference: 2022.0817-NL83111.029.22). We will publish our findings in peer-reviewed international journals.

TRIAL REGISTRATION NUMBER

ISRCTN97250704.

摘要

简介

眩晕是一种普遍且令人困扰的症状。超过 80%的眩晕患者主要由全科医生(GP)治疗,从未转诊给医学专家。尽管 GP 承担着治疗责任,但他们的诊断工具存在严重的局限性。所有推荐的检查都缺乏经验证据,因为在全科实践中从未进行过针对前庭障碍的诊断准确性研究(“测试 x 在区分患有或不患有目标病症 y 的患者方面的准确性如何?”)。VERtigo DIagnosis 研究旨在填补这一空白。

方法和分析

我们将在全科实践中针对原发性前庭源性眩晕进行一项诊断准确性研究,以评估病史采集和体格检查的鉴别能力。我们将比较所有的索引测试与各自的参考标准。我们将重点关注占全科实践中眩晕诊断 95%以上的五种目标病症:(1)良性阵发性位置性眩晕,(2)前庭神经炎,(3)梅尼埃病,(4)前庭性偏头痛(VM)和(5)除 VM 以外的中枢性病因。由于这五种目标病症具有不同的病理生理学,且缺乏普遍接受的金标准,我们将使用共识诊断作为结构参考标准。每位患者的数据,包括病史、体格检查以及国际 Delphi 程序中专家推荐的其他检查,将记录在标准化表格上,并由神经病学家和耳鼻喉科医生独立审查。对于每位患者,审查者必须决定是否存在每个目标病症。我们将计算每个目标病症的敏感性、特异性、预测值、似然比和诊断优势比,并随后制定每个目标病症的决策规则。

伦理和传播

该研究已获得 Vrije Universiteit Medical Center 医学伦理审查委员会的批准(参考号:2022.0817-NL83111.029.22)。我们将在同行评议的国际期刊上发表我们的研究结果。

试验注册号

ISRCTN97250704。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/295f/10989125/6d1bacf513cb/bmjopen-2024-085715f01.jpg

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