Assessment of Treatment Satisfaction in Psoriasis

银屑病治疗满意度评估

• 批准号: 10657012
• 负责人: April W Armstrong
• 金额: $ 20.03万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2023-07-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10657012
• 关键词: Adherence; Adverse effects; Affect; Behavior; California; Chronic small plaque psoriasis; Client satisfaction; Clinical; Clinical Trials; Clinical Trials Design; Consensus; Dermatologic; Dermatology; Development; Effectiveness; Evaluation; Flare; Future; Generations; Goals; International; Interview; Measurement; Measures; Methodology; Outcome; Outcome Measure; Patient Outcomes Assessments; Patient-Centered Care; Patients; Pharmaceutical Preparations; Prediction of Response to Therapy; Process; Psoriasis; Reporting; Research; Research Personnel; Sampling; Signs and Symptoms; Skin; Structure; Testing; Therapeutic Studies; Treatment Protocols; Treatment outcome; United States National Institutes of Health; Work; care delivery; clinical decision-making; clinical practice; cohort; design; experience; improved; instrument; medication compliance; novel; optimal treatments; patient population; prospective; recruit; satisfaction; shared decision making; side effect; success; systematic review; therapeutic candidate; treatment adherence; treatment pattern

PROJECT SUMMARY / ABSTRACT Treatments for plaque psoriasis vary substantially in effectiveness and side effects. It is often difficult to determine the optimal treatment during a patient-centric, shared decision-making process between the clinician and patient. The NIH and other stakeholders consider patient-reported outcomes (PROs) crucial for the support of patient-centered care because PROs reflect the patients’ perspective and offer important information to improve clinical decision-making and care delivery. Treatment satisfaction is a key PRO that represents the patient’s experience with the process and outcome of the treatment. Patient satisfaction with their treatment is critical because it affects patients’ treatment- related behaviors, such as the likelihood of continuing to use their medication, to use the medication correctly, and to adhere to prescribed treatment regimens. These treatment-related behaviors, in turn, substantially impact the success of treatment outcomes. The overarching goal of this study is to validate a patient-reported, dermatology-specific treatment satisfaction instrument (DermSat). In this study, we plan to achieve two aims. In Aim 1, we will validate DermSat for longitudinal assessment of patient satisfaction with psoriasis treatments during stable psoriasis and flares. We will also determine if DermSat will confer good reliability. We will study this aim in a prospective, observational cohort and recruit from a diverse psoriasis patient population in southern California. In Aim 2, we will determine whether DermSat predicts medication adherence and treatment changes. Specifically, we will evaluate the predictive validity of DermSat by examining the relationship between DermSat and subsequent assessment of adherence and treatment changes. A measure with excellent predictive validity will enable clinicians to identify treatment dissatisfaction and intervene earlier to minimize the long-term impact of psoriasis. The successful completion of this research will lead to the first valid and reliable dermatology-specific treatment satisfaction instrument. The study findings will have a marked impact on future clinical trial design. DermSat will address the critical need to capture patients’ treatment experience in studies for both approved and investigative dermatological therapies. Valid assessment of patients’ treatment satisfaction will also help inform shared decision-making between clinicians and patients in clinical practice, predict treatment adherence, and improve the likelihood of long-term treatment success.

项目摘要 /摘要 斑块牛皮癣的处理在有效性和副作用方面有很大差异。通常很难 确定以患者为中心的，共享决策过程的最佳治疗 临床和患者。 NIH和其他利益相关者认为对患者报告的结果（PRO）至关重要 以患者为中心的护理的支持是因为专业人士反映了患者的观点并提供了重要 信息以改善临床决策和护理提供。 治疗满意度是一个关键专业人士，代表患者在过程和结果中的体验 治疗。患者对治疗的满意至关重要，因为它会影响患者的治疗 - 相关行为，例如继续使用药物的可能性 正确地遵守规定的治疗方案。这些与治疗相关的行为反过来 实质上影响治疗结果的成功。 这项研究的总体目标是验证患者报告的，皮肤科特定的治疗 满意仪器（Dermsat）。在这项研究中，我们计划实现两个目标。在AIM 1中，我们将验证 皮肤化在稳定的牛皮癣期间对患者对牛皮癣治疗的纵向评估 和耀斑。我们还将确定Dermsat是否会赋予良好的可靠性。我们将研究这个目标 来自南部的潜水牛皮癣患者的前瞻性，观察队列和招募 加利福尼亚。 在AIM 2中，我们将确定DERMSAT是否可以预测药物依从性和治疗变化。 具体而言，我们将通过检查DERMSAT的预测有效性来检查 皮肤和随后评估依从性和治疗变化。一个极好的措施 预测有效性将使临床医生能够确定治疗不满并较早进行干预以最大程度地减少 牛皮癣的长期影响。 这项研究的成功完成将导致第一个有效且可靠的皮肤病学特定于皮肤病学 治疗满意度工具。研究结果将对未来的临床试验产生明显影响 设计。 Dermsat将解决捕获患者在研究方面的治疗经验的关键需求 批准和调查性皮肤病学疗法。有效评估患者的治疗满意度 还将帮助临床实践中的临床医生与患者之间的共同决策，预测 治疗依从性，并提高长期治疗成功的可能性。