Adaptation of the US-American pediatric Patient-Reported Outcome Measurement Information System (PROMIS) for the German speaking area

在过去的几年里，对患者自身主观观点的评估在医学和健康研究中越来越重要。这些所谓的以患者为导向的结果（PRO）不仅是临床领域和各种研究背景中的重要结果，而且可以用作医疗保健研究和医疗保健利用的指标。为了满足对PRO日益增长的需求，PROMIS（患者报告结果测量信息系统）网络于2004年在美国建立。PROMIS旨在制定标准化、可靠和有效的问卷，用于评估儿童和成人的健康状况，并在日常护理中实施。为此，国际可比的项目银行的开发，可用于集成静态纸笔问卷以及动态计算机自适应测试（CAT）到日常护理的长期运行。本研究建议的目的是将六个儿科美国PROMIS项目库翻译成通用德语版本并进行语言验证。翻译遵循通用方法，目标是获得适用于德语地区的通用德语版本。82个项目的前向翻译为三种语文版本。在对前向翻译进行协调后，产生了第一个通用德语版本，然后将其翻译成英语。这一回译的结果反馈到第一个通用德语版本。然后对60名儿童和青少年进行测试，以确保正确理解这些项目，并确定任何理解困难。焦点小组访谈进行了与家长的孩子，以测试代理版本。与美国PROMIS项目的合作不仅确保了标准化的方法和比较，而且为实施德国项目库提供了各种机会，例如作为CAT方案编制的基础。计算机辅助诊断不仅能够更好和更准确地评估个人健康状况，而且还有助于更可靠地估计儿童和青少年的保健服务和治疗需求。从长远来看，这也可以加强儿童及其家庭的参与和解放，这反过来又可以改善患者与医生的沟通，甚至患者的依从性。将在一项针对门诊、半住院和全住院儿童和青少年的多中心评价研究中测试CAT在常规护理中的有效性。预计这一方法最终将改善对儿童和青少年疾病负担的评估。

Over the past years, the assessment of the patient`s own subjective perspective has gained increasing importance in medicine and health research. These so called patient-oriented outcomes (PROs) are not only an important outcome in the clinical field and in various research contexts, but they can be used as indicators for health care research and health care utilization. To address the growing need for PROs, the PROMIS (Patient Reported Outcome Measurement Information System) network was established in the USA in 2004. PROMIS aims to develop standardized, reliable and valid questionnaires for the assessment of health in children and adults, and to implement these in routine care. For this purpose, internationally comparable item banks are developed, which can be used to integrate static paper-and-pencil questionnaires as well as dynamic computer-adaptive tests (CATs) into routine care in the long run. The objective of the present research proposal is the translation and linguistic validation of six pediatric US-American PROMIS item banks into a universal German version. The translation follows the universal approach with the goal to obtain a universal German version which is applicable in the German speaking area. The forward translation of 82 items occurs into three language versions. After the reconciliation of the forward translations, a first universal German version is produced which is then back-translated into English. Findings from this back-translation feed back to the first universal German version. This modified version is then tested on 60 children and adolescents to ensure that the items are understood correctly and to identify any comprehension difficulties. Focus group interviews are performed with the parents of the children to test the proxy-version. Collaboration with the US-American PROMIS project assures not only a standardized approach and comparison, but also opens diverse opportunities for the implementation of German item banks, e.g. as the basis for the programming of CATs. CATs not only enable a better and more precise assessment of the individual health status, but can furthermore contribute towards a more reliable estimate of the health provision and treatment needs of children and adolescents. In the long run, this can also strengthen the participation and emancipation of children and their families, which in turn can improve the patient-physician communication and even patient compliance. The effectiveness of CATs in routine care will be tested in a multicenter evaluation study on children and adolescents in outpatient, semi- and fully-inpatient care. It is to be expected that ultimately this approach will improve the assessment of disease burden in children and adolescents.