Logan Vera, Bamsey Alexander, Carter Neil, Hughes David, Turner Adam, Jordan Sue
Faculty of Medicine, Health and Life Sciences, Swansea University, Singleton Park, Swansea SA2 8PP, UK.
Mount Surgery, Swansea Bay University Health Board, Port Talbot SA13 2BN, UK.
Pharmacy (Basel). 2022 Apr 28;10(3):52. doi: 10.3390/pharmacy10030052.
(1) Aims: Adverse drug reactions (ADRs) particularly affect older people prescribed multiple medicines. The professional bodies of nursing, medicine and pharmacy have issued guidelines on identification and management of ADRs; however, ADRs continue to account for ~10% unplanned hospital admissions in the UK. Current methods of ADR identification and management could be improved by multidisciplinary collaboration involving nurses. The aim of this study is to examine the impact of implementing the nurse-led Adverse Drug Reaction (ADRe) Profile in UK primary care. (2) Design: A pragmatic cluster-randomised controlled trial (RCT) followed by qualitative interviews in a sequential mixed-methods study. (3) Methods: For the cluster RCT, 60 patients aged ≥65 prescribed ≥5 regular medicines for long-term conditions will be recruited, 10 in each of 6 general practices. The intervention arm ( = 30) will complete the ADRe Profile, whilst the control participants ( = 30) continue to receive usual, standard care. Primary outcomes will include clinical impact on patients, benefit and prescription changes. On completion of the RCT, participants will be invited to semi-structured qualitative interviews, to evaluate the impact of the ADRe Profile from stakeholders' perspectives, and to describe the contextual factors relevant to ADRe implementation. (4) Results: The findings of this study will evaluate the effectiveness of the ADRe Profile in identifying and resolving potential ADRs in primary care. Trial registration: This study was registered in ClinicalTrials.gov, registration number NCT04663360, date of registration-29 November 2021 (date of initial registration: 26 November 2020), protocol version 2, dated 8 January 2021.
（1）目的：药物不良反应（ADR）对服用多种药物的老年人影响尤为显著。护理、医学和药学专业机构已发布关于ADR识别与管理的指南；然而，在英国，ADR仍占非计划住院人数的约10%。当前ADR识别与管理方法可通过护士参与的多学科协作加以改进。本研究旨在探讨在英国初级医疗中实施由护士主导的药物不良反应（ADRe）概况的影响。（2）设计：一项实用的整群随机对照试验（RCT），随后在一项序贯混合方法研究中进行定性访谈。（3）方法：对于整群RCT，将招募60名年龄≥65岁、因长期病症服用≥5种常规药物的患者，在6家全科诊所中每家招募10名。干预组（n = 30）将完成ADRe概况，而对照组参与者（n = 30）继续接受常规标准护理。主要结局将包括对患者的临床影响、益处和处方变化。RCT完成后，将邀请参与者参加半结构化定性访谈，从利益相关者的角度评估ADRe概况的影响，并描述与ADRe实施相关的背景因素。（4）结果：本研究结果将评估ADRe概况在识别和解决初级医疗中潜在ADR方面的有效性。试验注册：本研究已在ClinicalTrials.gov注册，注册号为NCT04663360，注册日期为2021年11月29日（初始注册日期：2020年11月26日），方案版本2，日期为2021年1月8日。
