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老年人群药物不良反应(ADAPT)研究方案:一项关于老年患者药物不良反应相关住院情况的横断面和前瞻性队列研究。

Adverse Drug reactions in an Ageing PopulaTion (ADAPT) study protocol: a cross-sectional and prospective cohort study of hospital admissions related to adverse drug reactions in older patients.

作者信息

Cahir Caitriona, Curran Carmel, Byrne Catherine, Walsh Caroline, Hickey Anne, Williams David J, Bennett Kathleen

机构信息

Division of Population Health Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.

Department of Geriatric and Stroke Medicine, Royal College of Surgeons in Ireland and Beaumont Hospital, Dublin, Ireland.

出版信息

BMJ Open. 2017 Jun 9;7(6):e017322. doi: 10.1136/bmjopen-2017-017322.

Abstract

INTRODUCTION

Older people experience greater morbidity with a corresponding increase in medication use resulting in a potentially higher risk of adverse drug reactions (ADRs). The aim of this study is to determine the prevalence and characteristics of ADR-related hospital admissions among older patients (≥65 years) and their associated health and cost outcomes.

METHODS AND ANALYSIS

The proposed study will include a cross-sectional study of ADR prevalence in all patients aged ≥65 years admitted acutely to a large tertiary referral hospital in Ireland over a 9-month period (2016-2017) and a prospective cohort study of patient-reported health outcomes and costs associated with ADR-related hospital admissions. All acute medical admissions will be screened for a suspected ADR-related hospital admission. A number of validated algorithms will be applied to assess the type, causative medications, preventability and severity of each ADR. ADRs will be determined, using a consensus method, by an expert panel. Patients who provide consent will be followed up 3 months post-discharge to establish patient-reported health outcomes (health service use, health-related quality of life, adherence) and costs associated with ADR-related hospital admissions. A random sample of patients admitted to hospital without a suspected ADR will be invited to take part in the study as a control group.

ETHICS AND DISSEMINATION

Ethical approval was obtained from Beaumont Hospital Ethics Committee. Findings will be disseminated through presentations and peer-reviewed publications.

摘要

引言

老年人发病率更高,用药量相应增加,导致药物不良反应(ADR)风险可能更高。本研究的目的是确定老年患者(≥65岁)中与ADR相关的住院患病率及特征,以及其相关的健康和成本结果。

方法与分析

拟开展的研究将包括一项横断面研究,以确定2016 - 2017年9个月期间急性入住爱尔兰一家大型三级转诊医院的所有≥65岁患者的ADR患病率,以及一项前瞻性队列研究,以调查患者报告的与ADR相关住院的健康结果和成本。所有急性内科住院患者都将接受筛查,以确定是否为疑似与ADR相关的住院。将应用多种经过验证的算法来评估每种ADR的类型、致病药物、可预防性和严重程度。ADR将由一个专家小组采用共识方法确定。获得同意的患者将在出院后3个月进行随访,以确定患者报告的健康结果(医疗服务使用情况、健康相关生活质量、依从性)以及与ADR相关住院的成本。将邀请随机抽取的未疑似发生ADR的住院患者作为对照组参与研究。

伦理与传播

已获得博蒙特医院伦理委员会的伦理批准。研究结果将通过报告和同行评审出版物进行传播。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6049/5726049/453dcb38394c/bmjopen-2017-017322f01.jpg

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