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一项正在进行的通过强化药学服务预防跌倒的随机对照试验的方法学

Methodology of an ongoing, randomized controlled trial to prevent falls through enhanced pharmaceutical care.

作者信息

Ferreri Stefanie, Roth Mary T, Casteel Carri, Demby Karen B, Blalock Susan J

机构信息

Division of Pharmacy Practice and Experiential Education, School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7360, USA.

出版信息

Am J Geriatr Pharmacother. 2008 Jun;6(2):61-81. doi: 10.1016/j.amjopharm.2008.06.005.

DOI:10.1016/j.amjopharm.2008.06.005
PMID:18675765
Abstract

BACKGROUND

Falls are the leading cause of both fatal and nonfatal injuries among adults aged > or =65 years in the United States. Past research suggests that individuals taking multiple medications are at increased risk of falls. Central nervous system-active drugs in particular have been associated with increased risk.

OBJECTIVE

The goal of this research was to describe the design of a study evaluating the effectiveness of a community pharmacy-based falls prevention program. Also presented are the algorithms used to identify high-risk patients based on their prescription profile records and to deliver the experimental intervention.

METHODS

The study is a randomized controlled trial. The target population was community-dwelling older adults (aged > or =65 years) at high risk for future falls because: (1) they had experienced > or =1 fall within the 12-month period preceding study enrollment; (2) they were currently using > or =4 chronic prescription medications; and (3) they were taking > or =1 of the high-risk medications targeted by the intervention. Participants were recruited using pharmacy prescription profile records. Individuals in the intervention group received a face-to-face medication consultation provided by a community pharmacy resident. Identification of drug therapy problems and therapeutic recommendations was guided by a series of algorithms developed for this study. All participants were followed up for 24 months. The primary study end points were: (1) time to first fall; and (2) proportion of participants who experienced > or =1 fall during the first year of follow-up.

RESULTS

Participant enrollment began in September 2005 and was completed in August 2007. A total of 186 individuals were enrolled in the study (mean [SD] age, 74.8 [6.9] years; 132 women, 54 men), and 67 have completed the first year of follow-up.

CONCLUSIONS

The study is using a rigorous randomized controlled research design, which will enhance the internal validity of its findings. Results of the study, which will be reported after the completion of follow-up data collection activities, will enable us to assess the effects of the intervention on both medication use and the incidence of falls. If the intervention is found to be effective, it will provide a resource for community pharmacists working with older adults at high risk of medication-related falls.

摘要

背景

在美国,跌倒 是65岁及以上成年人致命和非致命伤害的主要原因。过去的研究表明,服用多种药物的个体跌倒风险增加。特别是中枢神经系统活性药物与风险增加有关。

目的

本研究的目的是描述一项评估基于社区药房的跌倒预防计划有效性的研究设计。还介绍了用于根据患者处方记录识别高危患者并实施实验性干预的算法。

方法

该研究为随机对照试验。目标人群是社区居住的老年人(65岁及以上),他们未来跌倒风险较高,原因如下:(1)在研究入组前12个月内经历过1次或以上跌倒;(2)目前正在使用4种或以上慢性处方药;(3)正在服用干预针对的1种或以上高危药物。通过药房处方记录招募参与者。干预组的个体接受社区药房住院医师提供的面对面用药咨询。药物治疗问题的识别和治疗建议由为本研究开发的一系列算法指导。所有参与者随访24个月。主要研究终点为:(1)首次跌倒时间;(2)随访第一年中经历1次或以上跌倒的参与者比例。

结果

参与者招募于2005年9月开始,2007年8月完成。共有186人纳入研究(平均[标准差]年龄,74.8[6.9]岁;女性132人,男性54人),67人完成了第一年随访。

结论

该研究采用了严格的随机对照研究设计,这将提高其研究结果的内部效度。随访数据收集活动完成后将报告研究结果,这将使我们能够评估干预对药物使用和跌倒发生率的影响。如果发现干预有效,将为与药物相关跌倒高危老年人合作的社区药剂师提供一种资源。

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