Duke University, Duke Clinical Research Institute, 2400 Pratt Street Durham, Durham, NC, 27705, USA.
Patient. 2018 Jun;11(3):285-300. doi: 10.1007/s40271-017-0295-z.
Stated-preference methods have been widely used to evaluate patient-relative preferences for the benefits and potential harms of psoriasis treatments. However, risk tolerance measures for treatment-related harms, a corollary of preferences, are rare despite their critical role in shared decision making and regulatory benefit-risk evaluations. This article presents a method to enhance information on patient risk tolerance through previously published preference results.
The objective of this article was to conduct the first meta-analysis of preferences to characterize the distribution of patients' maximum acceptable risk of harms associated with psoriasis treatments.
Maximum acceptable risks for treatment-related adverse events were extracted or derived from preference results published between 2011 and 2017.
Four different analyses were conducted to evaluate maximum acceptable risk information across studies: (1) listing of maximum acceptable risk values, (2) naïve aggregation of maximum acceptable risks, (3) estimation of maximum acceptable risk mother distribution, and (4) random-effect regression analysis of maximum acceptable risks.
Nine publications with maximum acceptable risk results, or with enough information to derive maximum acceptable risks, were identified from the search and screening of preference studies. The most commonly evaluated treatment benefits were duration of benefits, percentage and probability of improvement, and reductions in the coverage of lesions. The adverse-event risks most often included in the publications were those commonly associated with biologics, such as serious infections and malignancies. As expected, maximum acceptable risks changed with treatment benefits and treatment-related adverse events.
The results confirm the feasibility of using previously published preference information to characterize patient risk tolerance. The estimated distributions of maximum acceptable risk provide a benchmark against which future results can be compared, and signal gaps in our understanding of risk tolerance for specific health outcomes.
偏好评估法已被广泛用于评估患者对银屑病治疗获益和潜在危害的相对偏好。然而，尽管在共同决策和监管获益-风险评估中具有关键作用，但治疗相关危害风险容忍度的衡量标准（偏好的推论）却很少见。本文提出了一种通过已发表的偏好结果来增强有关患者风险容忍度信息的方法。
本文旨在进行首次偏好荟萃分析，以描述与银屑病治疗相关的危害最大可接受风险的患者分布情况。
从 2011 年至 2017 年发表的偏好研究中提取或推导了与治疗相关不良事件相关的最大可接受风险。
对研究间的最大可接受风险信息进行了四项不同的分析：（1）列出最大可接受风险值，（2）简单地汇总最大可接受风险，（3）估计最大可接受风险母分布，（4）对最大可接受风险进行随机效应回归分析。
通过偏好研究的检索和筛选，确定了 9 篇发表的具有最大可接受风险结果或具有足够信息来推导最大可接受风险的出版物。最常评估的治疗获益是获益持续时间、改善的百分比和概率以及皮损覆盖率的降低。最常包括在出版物中的不良事件风险是那些通常与生物制剂相关的风险，如严重感染和恶性肿瘤。正如预期的那样，最大可接受风险随治疗获益和治疗相关不良事件而变化。
结果证实了使用先前发表的偏好信息来描述患者风险容忍度的可行性。最大可接受风险的估计分布提供了一个基准，可以将未来的结果与之进行比较，并提示了我们对特定健康结果的风险容忍度的理解存在差距。
