Medication Monitoring in a Nurse-Led Respiratory Outpatient Clinic: Pragmatic Randomised Trial of the West Wales Adverse Drug Reaction Profile

Objective
To assess the clinical effect of medication monitoring using the West Wales Adverse Drug Reaction (ADR) Profile for Respiratory Medicine.
Design
Single-site parallel-arm pragmatic trial using stratified randomisation.
Setting
Nurse-led respiratory outpatient clinic in general hospital in South Wales.
Participants
54 patients with chronic respiratory disease receiving bronchodilators, corticosteroids or leukotriene receptor antagonists.
Intervention
Following initial observation of usual nursing care, we allocated participants at random to receive at follow up: either the West Wales ADR Profile for Respiratory Medicine in addition to usual care (‘intervention arm’ with 26 participants); or usual care alone (‘control arm’ with 28 participants).
Main Outcome Measures
Problems reported and actions taken.
Results
We followed up all randomised participants, and analysed data in accordance with treatment allocated. The increase in numbers of problems per participant identified at follow up was significantly higher in the intervention arm, where the median increase was 20.5 [inter-quartile range (IQR) 13–26], while that in the control arm was −1 [−3 to +2] [Mann-Whitney U test: z = 6.28, p<0.001]. The increase in numbers of actions per participant taken at follow up was also significantly higher in the intervention arm, where the median increase was 2.5 [1]–[4] while that in the control arm was 0 [−1.75 to +1] [Mann-Whitney U test: z = 4.40, p<0.001].
Conclusion
When added to usual nursing care, the West Wales ADR Profile identified more problems and prompted more nursing actions. Our ADR Profile warrants further investigation as a strategy to optimise medication management.
Trial Registration
Controlled-trials.com ISRCTN10386209

研究目的：评估采用西威尔士呼吸科药品不良反应（Adverse Drug Reaction, ADR）量表开展用药监测的临床效果。
研究设计：采用分层随机化的单中心平行对照实用性临床试验。
研究场景：南威尔士某综合医院内由护士主导的呼吸科门诊。
研究对象：54名患有慢性呼吸系统疾病、接受支气管扩张剂、糖皮质激素或白三烯受体拮抗剂治疗的患者。
干预措施：在完成常规护理的初步评估后，于随访阶段将受试者随机分为两组：一组接受西威尔士呼吸科ADR量表评估联合常规护理（干预组，共26名受试者）；另一组仅接受常规护理（对照组，共28名受试者）。
主要结局指标：报告的不良反应相关问题及采取的应对措施。
研究结果：本研究对所有随机分配的受试者完成了随访，并按照随机分组方案开展数据分析。随访阶段，干预组受试者识别出的人均问题数增幅显著高于对照组：干预组中位数增幅为20.5 [四分位距（inter-quartile range, IQR）13~26]，对照组中位数增幅为-1 [-3~+2] [曼-惠特尼U检验：z=6.28，p<0.001]。同时，干预组受试者人均采取的处置措施数增幅亦显著高于对照组：干预组中位数增幅为2.5 [1~4]，对照组中位数增幅为0 [-1.75~+1] [曼-惠特尼U检验：z=4.40，p<0.001]。
研究结论：在常规护理基础上附加西威尔士呼吸科ADR量表评估，可识别出更多用药相关不良反应问题并促使更多护理处置措施的实施。本ADR量表作为优化用药管理的策略，值得进一步开展研究验证。
临床试验注册：Controlled-trials.com ISRCTN10386209