Need for tailored clinical trials: hypertension and fall risk

需要量身定制的临床试验：高血压和跌倒风险

• 批准号: 7140603
• 负责人: MARY E TINETTI
• 金额: $ 16.36万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7140603
• 关键词: accidental falls; antihypertensive agents; balance; cardiovascular disorder; clinical trials; comorbidity; disease /disorder proneness /risk; experimental designs; gait; human old age (65+); human subject; hypertension; interview; outcomes research; pharmacokinetics; sign /symptom

DESCRIPTION (provided by applicant): Co-existing hypertension and fall risk, two common conditions in elderly persons, illustrate the gaps in knowledge regarding therapeutic decisions that best meet patients' priorities in the face of competing morbidities. Evidence suggests that anti-hypertensive medications improve cardiovascular, but worsen fall- related, outcomes. Clinical decision-making in the face of competing conditions should rely on patients' articulations of priorities and on tailoring therapy to meet these priorities, hallmarks of patient-centered care and shared decision-making. Unfortunately, there is currently little RCT evidence to guide this decision- making. The ultimate goal of the proposed line of investigation, of which this exploratory study is the first step, is to design trials that assess the effectiveness of interventions tailored to participants' outcome priorities in the face of coexisting competing conditions. In addition to showing that there is variability in outcome priorities in older persons with competing conditions - an important aim in itself - the proposed study will inform the future clinical trial by articulating the outcome priorities that need to be considered in designing the trial and in selecting the subarms of the tailored intervention arm. The primary aim of this exploratory study is to determine whether there is inter-individual variability in the priority given to optimizing cardiovascular versus fall- and medication symptom-related outcomes among elderly (70+years) persons with coexisting hypertension and fall risk, defined as a fall within the last 6 months or self-reported or observed difficulty with balance or gait. The secondary aim will be to determine the association between outcome priorities and sociodemographic and health-related characteristics. We will use a cluster sampling design to enroll 232 community-living persons 70+ years with coexisting hypertension and fall risk. All data collection will take place during a single approximately one- hour visit in participants' homes. Outcome priorities will be obtained with Adaptive Conjoint Analysis, a well- validated, reliable approach to eliciting health outcome priorities in the face of competing risks. The 3 priority outcome options include: 1) Maximum reduction of CVD outcomes, possible presence of anti-hypertensive medication symptoms, maximum increase in the risk of serious fall injury; 2) Moderate decrease in the risk of CVD outcomes, absence of anti-hypertensive medication symptoms, moderate increase in the risk of serious fall injury; and 3) No decrease in CVD outcomes, absence of anti-hypertensive medication symptoms, no increase in the risk of serious fall injury. Although studies of persons with life-threatening illness suggest that prioritization of outcomes in the face of competing morbidities will be variable, this hypothesis has not been examined. The proposed study will test this hypothesis.

描述(由申请人提供)：高血压和跌倒风险并存，这是老年人中的两种常见疾病，说明在面对相互竞争的疾病时，关于最符合患者优先事项的治疗决定的知识差距。有证据表明，抗高血压药物可以改善心血管疾病，但会恶化与跌倒相关的结果。面对相互竞争的情况，临床决策应该依赖于患者对优先事项的阐明，并依靠量身定制的治疗来满足这些优先事项，这些优先事项是以患者为中心的护理和共享决策的标志。不幸的是，目前几乎没有随机对照试验的证据来指导这一决策。这项探索性研究是第一步，拟议的调查路线的最终目标是设计试验，评估在共存的竞争条件下，根据参与者的结果优先顺序量身定做的干预措施的有效性。除了表明患有竞争性疾病的老年人的结果优先顺序存在差异--这本身就是一个重要的目标--之外，拟议的研究还将通过阐明在设计试验和选择量身定制的干预臂的亚臂时需要考虑的结果优先顺序，为未来的临床试验提供信息。 这项探索性研究的主要目的是确定在老年(70岁以上)合并高血压和跌倒风险(定义为在过去6个月内跌倒或自我报告或观察到平衡或步态困难)的老年人中，在优化心血管与跌倒症状相关结果方面是否存在个体间的差异。次要目标将是确定结果优先事项与社会人口和健康相关特征之间的联系。 我们将采用整群抽样设计，纳入232名70岁以上合并高血压和跌倒风险的社区居民。所有数据收集将在参与者家中进行一次约一小时的访问。将通过自适应联合分析获得结果优先级，这是一种在面对竞争风险时得出健康结果优先级的经过充分验证的可靠方法。这3个优先结果选项包括：1)最大限度地减少心血管疾病结局，可能存在抗高血压药物症状，严重坠落伤害的风险最大程度增加；2)适度降低心血管结局风险，没有抗高血压药物症状，严重坠落伤害风险适度增加；以及3)心血管疾病结局没有下降，没有抗高血压药物症状，严重坠落伤害风险没有增加。 尽管对危及生命的疾病患者的研究表明，在面对相互竞争的疾病时，结果的优先顺序将是可变的，但这一假设尚未得到检验。这项拟议的研究将检验这一假设。