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: 7009156
• 负责人: MARY E TINETTI
• 金额: $ 19.95万
• 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/7009156
• 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）：共存的高血压和跌倒风险，这是老年人的两个常见条件，说明了有关治疗决定的知识差距，这些决策在面对竞争性病态时最能满足患者优先事项的治疗决定。有证据表明，抗高血压药物可改善心血管，但相关的结果恶化。面对竞争条件的临床决策应依靠患者的优先事项表达和调整治疗来满足这些优先事项，以患者为中心的护理和共同的决策。不幸的是，目前几乎没有RCT证据可以指导这一决策。拟议的调查系列的最终目标是，这项探索性研究是第一步，是设计试验，以评估面对共存竞争条件的参与者成果优先级的干预措施的有效性。除了表明具有竞争条件的老年人的结果优先级（本身就是一个重要的目标）外，该研究的结果优先级还将为未来的临床试验提供信息，通过阐明在设计试验时需要考虑的结果优先级并选择量身定制干预部门的副臂。 这项探索性研究的主要目的是确定优先级别的人间差异是在优化心血管与跌倒和药物症状相关的结果的优先级中是否存在相关性（70多年）患有共存高血压和跌倒风险的人之间的差异，并在过去6个月内定义为在过去6个月内定义为在过去6个月内跌倒或自我报道或与平衡的困难或衡量的困难。次要目的是确定结果优先级与社会人口统计学和与健康相关的特征之间的关联。 我们将使用群集抽样设计来招募232名社区生活70多年的社区生活，并共存高血压和跌倒风险。所有数据收集都将在参与者家中大约一小时访问中进行。将通过自适应联合分析获得结果优先级，这是一种良好的，可靠的方法，可在面对竞争风险的情况下引起健康结果优先级。这3种优先级结果选项包括：1）最大减少CVD结局，可能存在抗高血压药物症状，最大程度地增加严重跌倒损伤的风险； 2）在CVD结局的风险，缺乏抗高血压药物症状，严重跌倒损伤风险中等增加的风险中，中度降低； 3）CVD结局没有减少，缺乏抗高血压药物症状，严重跌倒损伤的风险没有增加。 尽管对威胁生命的疾病的人的研究表明，面对竞争性病的结果的优先次序将是可变的，但尚未研究该假设。拟议的研究将检验这一假设。