Effects of a clinical medication review focused on personal goals, quality of life, and health problems in older persons with polypharmacy: A randomised controlled trial (DREAMeR-study)

BackgroundClinical medication reviews (CMRs) are increasingly performed in older persons with multimorbidity and polypharmacy to reduce drug-related problems (DRPs). However, there is limited evidence that a CMR can improve clinical outcomes. Little attention has been paid to patients’ preferences and needs. The aim of this study was to investigate the effect of a patient-centred CMR, focused on personal goals, on health-related quality of life (HR-QoL), and on number of health problems.Methods and findingsThis study was a randomised controlled trial (RCT) performed in 35 community pharmacies and cooperating general practices in the Netherlands. Community-dwelling older persons (≥70 years) with polypharmacy (≥7 long-term medications) were randomly assigned to usual care or to receive a CMR. Randomisation was performed at the patient level per pharmacy using block randomisation. The primary outcomes were HR-QoL (assessed with EuroQol [EQ]-5D-5L and EQ-Visual Analogue Scale [VAS]) and number of health problems (such as pain or dizziness), after 3 and 6 months. Health problems were measured with a self-developed written questionnaire as the total number of health problems and number of health problems with a moderate to severe impact on daily life. Between April 2016 and February 2017, we recruited 629 participants (54% females, median age 79 years) and randomly assigned them to receive the intervention (n = 315) or usual care (n = 314). Over 6 months, in the intervention group, HR-QoL measured with EQ-VAS increased by 3.4 points (95% confidence interval [CI] 0.94 to 5.8; p = 0.006), and the number of health problems with impact on daily life decreased by 12% (difference at 6 months −0.34; 95% CI −0.62 to −0.044; p = 0.024) as compared with the control group. There was no significant difference between the intervention group and control group for HR-QoL measured with EQ-5D-5L (difference at 6 months = −0.0022; 95% CI −0.024 to 0.020; p = 0.85) or total number of health problems (difference at 6 months = −0.30; 95% CI −0.64 to 0.054; p = 0.099). The main study limitations include the risk of bias due to the lack of blinding and difficulties in demonstrating which part of this complex intervention (for example, goal setting, extra attention to patients, reducing health problems, drug changes) contributed to the effects that we observed.ConclusionsIn this study, we observed that a CMR focused on personal goals improved older patients’ lives and wellbeing by increasing quality of life measured with EQ-VAS and decreasing the number of health problems with impact on daily life, although it did not significantly affect quality of life measured with the EQ-5D. Including the patient’s personal goals and preferences in a medication review may help to establish these effects on outcomes that are relevant to older patients’ lives.Trial registrationNetherlands Trial Register; NTR5713背景 临床药物审查（Clinical medication reviews, CMRs）在合并多种疾病且多重用药的老年人群中应用日益广泛，旨在减少药物相关问题（drug-related problems, DRPs）。然而，目前仅有有限证据表明CMR可改善临床结局，且对患者偏好与需求的关注尚且不足。本研究旨在探讨以患者为中心、聚焦个人目标的CMR对健康相关生活质量（health-related quality of life, HR-QoL）以及健康问题数量的影响。 方法与结果 本研究为一项随机对照试验（randomised controlled trial, RCT），在荷兰35家社区药房及合作全科诊所开展。研究对象为年龄≥70岁、存在多重用药（服用≥7种长期处方药物）的社区居住老年受试者，按患者个体水平在各药房内采用区组随机化方法，将其随机分配至常规护理组或CMR干预组。主要结局指标为干预后3个月和6个月时的HR-QoL以及健康问题数量（如疼痛、眩晕等）；其中HR-QoL采用欧洲五维健康量表5级版（EuroQol EQ-5D-5L）与EQ视觉模拟评分法（EQ-Visual Analogue Scale, EQ-VAS）进行评估。健康问题通过自制书面问卷进行测量，统计指标包括健康问题总数，以及对日常生活存在中重度影响的健康问题数量。2016年4月至2017年2月期间，本研究共招募629名受试者（54%为女性，中位年龄79岁），并将其随机分配至干预组（n=315）或常规护理组（n=314）。随访6个月后，与对照组相比，干预组患者经EQ-VAS评分测得的HR-QoL提升了3.4分（95%置信区间[confidence interval, CI] 0.94~5.8；p=0.006），对日常生活存在影响的健康问题数量减少了12%（6个月时组间差异为-0.34；95%CI -0.62~-0.044；p=0.024）。而两组在EQ-5D-5L评分测得的HR-QoL（6个月时组间差异为-0.0022；95%CI -0.024~0.020；p=0.85）以及健康问题总数（6个月时组间差异为-0.30；95%CI -0.64~0.054；p=0.099）方面均无显著统计学差异。本研究的主要局限性包括：因未设盲带来的偏倚风险，以及难以明确该复杂干预措施中的哪些组成部分（例如目标设定、对患者的额外关注、健康问题干预、药物调整）促成了观测到的干预效果。 结论 本研究结果显示，以个人目标为导向的CMR可通过提升EQ-VAS评分所衡量的生活质量、减少对日常生活存在影响的健康问题数量，改善老年受试者的生活与健康状况，尽管其对EQ-5D量表所评估的生活质量无显著影响。在药物审查过程中纳入患者的个人目标与偏好，或有助于实现与老年患者生活密切相关的结局改善。 试验注册 荷兰试验注册库（Netherlands Trial Register）；NTR5713