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，用于评估与患者相关的治疗目标和青少年寻常痤疮的益处。寻常型痤疮主要表现在12-18岁。它的患病率超过80%，是德国最常见的皮肤病。40%的患者表现为慢性病程，有长期的炎症模式，并有临床治疗需求。重要的是受影响者的相当大的心理和社会损伤。在疾病实际存在之后，这些症状可能会持续很多年。对于这些损害的全面评估，除了对疾病严重程度的客观评估外，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，需要心理测量学测试工具。因此，患者福利指数(PBI)应运而生。PBI评估患者定义的治疗目标和好处。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“患者利益问卷”对治疗目标的实现程度进行评分。每个患者的总价值是通过根据他们对个别患者的重要性来权衡所获得的好处来计算的。最初的版本是为各种皮肤病开发的，并经过验证可用于其他疾病(也可用于成人痤疮)。然而，对于患有寻常痤疮的青少年，仍然缺乏与患者相关的目标和益处评估的工具。因此，目的是为12至18岁的寻常痤疮青少年开发一种PBI。该开发将根据国际仪器开发指南进行。首先，将制定项目和回应选项。12至18岁患有寻常痤疮的青少年将接受单独(n=18)和小组讨论(n=24)的采访，了解他们的缺陷和需求。将对数据进行定性分析。根据结果，将在协商一致的会议上拟订项目和应对办法，随后将对试行版本进行可理解性和相关性测试。这将在与受影响者(n=32)的面谈中进行调查。访谈将进行定性分析，如有必要，将对试行版本进行修改。在随后的研究中，将对该仪器进行横断面和纵向验证。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，以确定对患者的好处。

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.