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 斑块型牛皮癣的治疗在有效性和副作用方面存在很大差异。通常很难做到 在以患者为中心的共同决策过程中确定最佳治疗方案 临床医生和病人。NIH和其他利益相关者认为患者报告的结果(PRO)对 支持以患者为中心的护理，因为专业人员反映了患者的观点，并提供了重要的 改善临床决策和护理提供的信息。 治疗满意度是代表患者对治疗过程和结果的体验的关键指标 对治疗的影响。患者对治疗的满意度至关重要，因为这会影响患者的治疗- 相关行为，如继续使用药物的可能性，使用药物的可能性 正确，并坚持规定的治疗方案。这些与治疗相关的行为，反过来， 在很大程度上影响治疗结果的成功。 这项研究的首要目标是验证患者报告的皮肤病特异性治疗。 满意度测定仪(DemSat)。在这项研究中，我们计划实现两个目标。在目标1中，我们将验证 用于纵向评估稳定期银屑病患者对银屑病治疗满意度的皮肤卫星 还有照明弹。我们还将确定真皮卫星是否具有良好的可靠性。我们将对这一目标进行研究 从南部不同的银屑病患者人群中进行前瞻性、观察性队列和招募 加利福尼亚。 在目标2中，我们将确定真皮卫星是否可以预测药物依从性和治疗变化。 具体地说，我们将通过检查以下两者之间的关系来评估DermSat的预测有效性 DemSat和随后的依从性评估和治疗变化。一项极好的措施 预测效度将使临床医生能够识别治疗不满并及早干预以将其降至最低 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和可靠的皮肤病专科研究 治疗满意度测定仪。这项研究结果将对未来的临床试验产生显著影响 设计。DermSat将解决在这两项研究中获取患者治疗经验的关键需求 批准和研究的皮肤病疗法。患者治疗满意度的有效测评 还将有助于在临床实践中为临床医生和患者之间的共享决策提供信息， 治疗依从性，提高长期治疗成功的可能性。