How redesigning AD clinical trials might increase study partners' willingness to participate.
How redesigning AD clinical trials might increase study partners' willingness to participate.
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DOI：
10.1212/01.wnl.0000336652.05779.ea
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发表时间：
2008-12-02
期刊：
影响因子：
9.9
通讯作者：
Tenhave T
中科院分区：
文献类型：
--
作者：
Karlawish J;Cary MS;Rubright J;Tenhave T
及时招募和留住参与者进入AD临床试验是一项挑战。我们使用联合分析来确定临床试验设计属性的改变如何提高参与意愿：风险，家访，汽车服务或接受干预的机会增加。108名极轻度至重度AD患者的研究伙伴评估了允许其亲属参加8项临床试验的意愿，这些临床试验改变了四种属性的组合。效用最高的是家访（0.89），基本上弥补了高风险的负效用（-0.85）。家访和汽车服务的结合是多余的，与单独的家访相比，几乎没有增加效用。17%的人愿意参加没有便利设施的试验;增加家访将预测的参与意愿提高到27%;低风险、家访和更高的积极治疗机会将预测的参与意愿提高到60%。减少旅行烦恼的价值与AD严重程度的测量值相关良好（ADL r=0.41，p<0.001; BADL r=0.38，p<0.001; NPIQ严重程度p=0.24，p=0.01; NPIQ困扰r=0.23，p<0.02）。研究伴侣的负担程度与愿意忍受干预风险之间没有关联。减少旅行不便的临床试验可能会抵消研究特征（如干预风险）的抑制作用，也可能会增加参与意愿。重新设计试验也可能有助于招募更严重的AD患者。缩短征聘期和提高留用率可抵消这些变化的费用。
Timely recruiting and retaining participants into AD clinical trials is a challenge. We used conjoint analysis to identify how alterations in attributes of clinical trial design improve willingness to participate: risk, home visits, car service, or increased chance of receiving intervention. 108 study partners of very mild to severe stage AD patients rated willingness to allow their relative to participate in 8 clinical trials that varied combinations of the four attributes. The highest utility was for home visits (0.89) which essentially compensated for the disutility of high risk (−0.85). The combination of home visits and car service was redundant, with almost no increase in utility over home visits alone. Seventeen percent were willing to participate in a trial with no amenities; the addition of home visits increased predicted willingness to participate to 27%; low risk, home visits, and higher chance of active treatment increased predicted willingness to 60%. The value of reducing the hassles of travel correlated well with measures of AD severity (ADL r=0.41, p<0.001; BADL r=0.38, p<0.001; NPIQ severity p=0.24, p=0.01; NPIQ distress r=0.23, p<0.02). No association was found between degree of study partner burden and willingness to tolerate risk of an intervention. Clinical trials that reduce travel inconvenience may offset the disincentive of study features such as the risk of intervention and may also increase willingness to participate. Redesigning trials may also help recruit patients with more severe AD. Shorter recruitment periods and increased retention rates may offset costs of these changes.
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DOI：
10.1198/016214502388618410
发表时间：
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影响因子：
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