Assessment of the patient perspective in children and adolescents with acne – Development of the Patient Benefit Index in Acne Youth (PBI-AY)

该项目旨在开发一种工具，用于评估青少年寻常痤疮患者相关的治疗目标和获益。寻常痤疮主要表现在12-18岁的年龄。在德国，它的患病率超过80%，是最常见的皮肤病。 40%的患者表现为慢性病程，具有长期炎症模式，需要临床治疗。重要的是，受影响者的心理和社会损害相当严重。这些可以持续多年，超过疾病的实际存在。关于对这些损害的完整评估，除了对疾病严重程度的客观评估之外，还需要从患者的角度对治疗目标和益处进行主观评估。为了对患者的观点进行标准化评估，需要心理测量测试仪器。因此，制定了患者受益指数（PBI）。PBI评估患者定义的治疗目标和获益。治疗前，患者完成标准化的“患者需求问卷”，了解不同治疗目标的个体重要性。在治疗过程中，患者使用“患者获益问卷”评定治疗目标的实现程度。通过根据其对个体患者的重要性对所实现的获益进行加权，计算每例患者的总体价值。最初的版本被开发用于各种皮肤疾病，并被验证用于其他疾病（也用于患有痤疮的成年人）。然而，对于青少年寻常痤疮，患者相关的目标和效益评估的工具仍然缺乏。因此，我们的目标是为12 - 18岁的青少年寻常痤疮患者制定PBI，并根据国际仪器开发指南进行开发。首先，将制定项目和应对方案。将对12至18岁的寻常痤疮青少年进行单独访谈（n=18）和小组讨论（n=24），了解他们的障碍和需求。将对数据进行定性分析。根据评估结果，将在一次协商一致会议上制定项目和应对方案，然后对试点版本进行可理解性和相关性测试。这将在与受影响者（n=32）的访谈中进行调查。将对访谈进行定性分析，必要时将对试点版本进行修订。在随后的研究中，将对该工具进行横截面和纵向验证。如果它被证明是有效和可行的，它可以用于未来的临床研究和实践中，以确定患者的利益。

This project aims to develop an instrument for the assessment of patient-relevant treatment goals and benefit in adolescents with acne vulgaris. Acne vulgaris manifests primarily at the age of 12-18 years. With a prevalence of more than 80% it is the most common skin disease in Germany. 40% of the patients show a chronic course with long-term inflammatory patterns and a clinical need for treatment. Of importance are the considerable psychological and social impairments of those affected. These can last for many years beyond the actual presence of the disease. With regard to a complete assessment of these impairments, next to an objective assessment of the disease severity, a subjective assessment of the treatment goals and benefits from the patient's perspective is needed. For a standardized assessment of the patient’s perspective, psychometrically tested instruments are needed. Therefore, the Patient Benefit Index (PBI) was developed. The PBI assesses patient-defined treatment goals and benefits. Before treatment, the patient completes the standardized “Patient Needs Questionnaire” on the individual importance of different treatment goals. During the course of treatment, the patient rates the extent to which the treatment goals have been achieved using the "Patient Benefit Questionnaire". An overall value is calculated for each patient by weighting the benefits achieved according to their importance for the individual patient. The original version was developed for use in various skin diseases and was validated for other diseases (also for use in adults with acne). For adolescents with acne vulgaris, however, an instrument for patient-related goal and benefit assessment is still lacking. Therefore, the aim is to develop a PBI for adolescents with acne vulgaris aged 12 to 18 years.The development will be performed according to international guidelines of instrument development. First, items and response options will be developed. Adolescents with acne vulgaris between the ages of 12 and 18 years will be interviewed individually (n=18) and in group discussions (n=24) about their impairments and needs. The data will be analyzed qualitatively. Based on the results, items and response options will be formulated within a consensus meeting.This will be followed by a comprehensibility and relevance testing of the pilot version. This will be investigated in interviews with those affected (n=32). The interviews will be analyzed qualitatively and the pilot version will be revised if needed. In a subsequent study, the instrument will be validated cross-sectional and longitudinally. If it proves to be valid and feasible, it can be used in future clinical studies and in practice to determine the benefit for patients.