康复与长期照护部门中口咽性吞咽困难的早期检测：EDOR-Care横断面研究方案

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中文摘要

引言： 口咽性吞咽困难（OD），即吞咽困难，是一种常见但常被漏诊的疾病，可导致严重并发症、生活质量下降和医疗费用增加。因此，早期识别高危患者至关重要。尽管诸如容积-黏度吞咽试验（V-VST）等筛查工具被广泛使用，但它们仍然耗时、需要经过培训的工作人员，并且往往仅在特定人群中得到验证（例如卒中后患者）。本研究旨在：第一，确定康复和长期照护单元中OD风险的患病率；第二，量化床边护士与经过专门培训的护士使用相同机构筛查工具之间的一致性；第三，评估两种更省时、更易使用的机构工具相对于作为对照标准的V-VST的校标效度。将识别与OD相关的临床危险因素和患者特征，以开发一种简单、快速且可靠的预测风险评分。该工具设计用于非专科工作人员在入院时使用，应有助于早期检测并优化不同照护环境中的资源配置。
方法： 本横断面研究将对入住临床神经科学系和康复与老年医学系康复单元及长期照护部门的所有成年住院患者进行OD筛查，即预计连续且无遗漏地招募457-487名患者，不采用随机抽样。主要结局是OD的患病率，将与已发表的估计值进行比较。次要结局将包括识别危险因素和临床特征、评估床边护士与经过专门培训的护士之间的一致性、验证两种机构筛查工具相对于V-VST的效度，以及开发用于入院时早期检测的预测风险评分。分析将包括比例及95%置信区间、多变量logistic回归、百分比一致性和Cohen's kappa、敏感性、特异性、预测值和似然比，以及开发基于评分的风险评分并通过自举法进行内部验证。
伦理与传播： 本研究已获得伦理委员会批准（2025-00401）。本手稿报告的是研究方案：在提交时，尚未筛查任何参与者，也未收集任何数据。计划纳入时间为2027年1月4日至2027年6月30日。研究结果将通过同行评审的科学期刊和会议进行传播。如果经过内部验证，该预测评分可在研究机构内有助于早期识别有OD风险的患者；任何更广泛的临床使用都需要独立的外部验证，并遵守适用的医疗器械法规。

英文摘要

INTRODUCTION: Oropharyngeal dysphagia (OD), or difficulty swallowing, is a common yet frequently underdiagnosed condition that can lead to serious complications, reduced quality of life and increased healthcare costs. Early identification of at-risk patients is therefore essential. Although screening tools such as the Volume-Viscosity Swallow Test (V-VST) are widely used, they remain time-consuming, require trained staff and are often validated only in specific populations (eg, patients who had a post-stroke). This study aims first to establish the prevalence of OD risk in rehabilitation and long-term care units; second, to quantify the agreement between bedside nurses and specially trained nurses using the same institutional screening tools; and third, to estimate the criterion validity of two institutional tools less time-consuming and easier to use against the V-VST, used as the comparator standard. Clinical risk factors and patient characteristics associated with OD will be identified to develop a simple, rapid and reliable predictive risk score. Designed for use by non-specialised staff at admission, this tool should support early detection and optimise resource allocation across diverse care settings.
METHODS AND ANALYSIS: This cross-sectional study will screen for OD all adult inpatients admitted to rehabilitation units and long-term care sectors of the Departments of Clinical Neurosciences and Rehabilitation & Geriatrics, that is, an expected total of 457-487 patients recruited consecutively and exhaustively without random sampling. The primary outcome is the prevalence of OD, which will be compared with published estimates. Secondary outcomes will include identifying risk factors and clinical characteristics, assessing the agreement between bedside nurses and specially trained nurses, validating two institutional screening tools against the V-VST and developing a predictive risk score for early detection at admission. Analyses will comprise proportions with 95% CIs, multivariable logistic regression, percentage agreement and Cohen's kappa, sensitivity, specificity, predictive values and likelihood ratios, and development of a points-based risk score with internal validation by bootstrapping.
ETHICS AND DISSEMINATION: The study has received ethics committee approval (2025-00401). This manuscript reports the study protocol: at the time of submission, no participant had been screened, and no data had been collected. Inclusions are planned from 4 January 2027 to 30 June 2027. Findings will be disseminated through peer-reviewed scientific journals and conferences. If internally validated, the predictive score could inform early identification of patients at risk of OD within the study institution; any broader clinical use would require independent external validation and compliance with the applicable medical device regulations.