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）：并存的高血压和跌倒风险是老年人的两种常见病症，说明了在面对相互竞争的发病情况时，在最能满足患者优先事项的治疗决策方面的知识差距。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。面对竞争性条件的临床决策应依赖于患者对优先事项的阐述，并根据这些优先事项调整治疗，这是以患者为中心的护理和共同决策的标志。不幸的是，目前几乎没有随机对照试验证据来指导这一决策。拟议的调查路线的最终目标（本次探索性研究是第一步）是设计试验，评估针对参与者在共存竞争条件下的结果优先事项量身定制的干预措施的有效性。除了表明患有竞争性条件的老年人的结果优先级存在差异（这本身就是一个重要目标）之外，拟议的研究还将通过阐明在设计试验和选择定制干预组的子组时需要考虑的结果优先级来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患有高血压和跌倒风险（定义为过去 6 个月内跌倒或自我报告或观察到的平衡或步态困难）的老年人（70 岁以上）中，优化心血管与跌倒和药物症状相关结局的优先顺序是否存在个体差异。第二个目标是确定结果优先事项与社会人口和健康相关特征之间的关联。 我们将采用整群抽样设计，招募 232 名 70 岁以上患有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大约一小时的访问期间进行。成果优先事项将通过自适应联合分析获得，这是一种经过充分验证的可靠方法，可在面临竞争风险时得出健康成果优先事项。 3 个优先结局选项包括： 1) 最大程度地减少 CVD 结局、可能出现抗高血压药物症状、最大程度地增加严重跌倒受伤的风险； 2) CVD结局风险中度降低，无抗高血压药物症状，严重跌倒损伤风险中度增加； 3) CVD结果没有减少，没有抗高血压药物症状，严重跌倒受伤的风险没有增加。 尽管对患有危及生命的疾病的人的研究表明，面对相互竞争的疾病，结果的优先顺序会有所不同，但这一假设尚未得到检验。拟议的研究将检验这一假设。