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.

项目总结/摘要 治疗斑块型银屑病的有效性和副作用差异很大。往往很难 在以患者为中心的共享决策过程中确定最佳治疗， 临床医生和患者。NIH和其他利益相关者认为患者报告的结果（PRO）对于 支持以病人为中心的护理，因为PRO反映了病人的观点， 信息，以改善临床决策和护理服务。 治疗满意度是一个关键的PRO，代表了患者对过程和结果的体验 的治疗。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，例如继续使用药物的可能性，使用药物 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， 对治疗结果的成功有很大影响。 本研究的首要目标是验证患者报告的皮肤科特异性治疗 满意度测量仪（DermSat）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 DermSat用于银屑病稳定期患者对银屑病治疗满意度的纵向评估 和照明弹。我们还将确定DermSat是否具有良好的可靠性。我们将在一个 前瞻性、观察性队列研究，并从南方不同银屑病患者人群中招募 加州。 在目标2中，我们将确定DermSat是否能预测药物依从性和治疗变化。 具体来说，我们将通过检查以下因素之间的关系来评估DermSat的预测有效性： DermSat和随后的依从性和治疗变化评估。一个很好的衡量标准， 预测有效性将使临床医生能够识别治疗不满意，并尽早干预，以最大限度地减少 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和可靠的皮肤科特异性 治疗满意度量表研究结果将对未来的临床试验产生显著影响 设计DermSat将满足在研究中获取患者治疗经验的关键需求， 批准和研究性皮肤病治疗。患者治疗满意度的有效评估 还将有助于在临床实践中告知临床医生和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。