IntroductionThe project “INTEGRAL−10-year evaluation of the population-based integrated health care model ‘Gesundes Kinzigtal’ (Healthy Kinzigtal)” (ICM-GK) is funded by the Innovation Committee of the Federal Joint Committee (G-BA) (grant no. 01VSF16002). The evaluation is to be based on a set of indicators that can be captured in routine data. On the one hand, they can be used to assess ICM-GK programs that are program-specific and geared towards prevention and disease management. On the other hand, possible negative side effects of the ICM-GK, which is designed as a “shared savings contract”, are to be examined by also observing care needs not covered by the ICM-GK contract. Since an indicator set for the evaluation of regional integrated care (IC) programs in Germany is not yet available, a suitable indicator set should be developed. Methods1.Defining a methodological framework for the development of indicators based on concepts from the literature2.Searching for potential quality indicators (QIs) a) in the literature (PubMed, Web of Science, Cochrane, Embase) and b) in indicator databases3.Conducting document analysis of the ICM-GK programs4.Conducting focus groups with patients, doctors and ICM-GK stakeholders5.Merging QIs from the various sources, removing duplicates, comparing the indicators with the data basis of routine statutory health insurance data6.Allocating indicators to disease categories, care needs and quality dimensions according to OECD and Donabedian7.Evaluating and consenting the indicators by a multidisciplinary group of experts using the modified RAND-UCLA Appropriateness Method (RAM) based on the relevance and feasibility of the indicators ResultsThe methodological framework links the OECD concept for quality assessment of health systems with Kessner's tracer methodology. Disease groups with a high prevalence (“common diseases”), prevention potential and potential for improvement through IC were selected as tracers. The literature search resulted in 239 QIs and the QI database search in 293 QIs, which were supplemented by 21 QIs from the focus groups. Out of a total of 553 QIs, 251 QIs remained after removal of duplicates and comparison with the data basis. This preliminary QI set was reduced to 101 QIs by consensus. In addition, 48 health reporting indicators were supplemented which serve to classify regional quality results. The final QI set maps the following 19 disease categories/tracers: heart failure (16 QIs), myocardial infarction (4 QIs), CHD (10 QIs), stroke (6 QIs), metabolic syndrome (7 QIs of which 5 were diabetes-related), COPD (6 QIs), asthma (3 QIs), chronic pain (5 QIs), back pain (3 QIs), geriatrics (7 QIs), dementia (8 QIs), osteoporosis (3 QIs), rheumatism (3 QIs), multiple sclerosis (2 QIs), depression (4 QIs), antibiotic therapy (3 QIs), drug safety (1 QI), child care (5 QIs), early detection/prevention (5 QIs). 33 of these QIs are dedicated to five tracers that are not explicitly ICM-GK programs. Most QIs assess aspects of the effectiveness of care for the chronically ill and measure process quality. DiscussionThe set of indicators initially enables the quality assessment of regional, cross-indication care quality in the population-based integrated health care model ‘Gesundes Kinzigtal’ on the basis of routine data. Although the QI set focuses on effectiveness and process quality, it also includes QIs for preventive and acute care, coordination of care, patient orientation and safety, and outcomes. In contrast to other QI sets, both primary care and specialist health care and integrated, cross-sectoral and cross-professional care aspects have been considered. The benefits of the QI set for comparisons of regional quality and the evaluation of different IC programs remain to be tested. ConclusionOn the basis of a broadly based research and participatory development process, a set of indicators has been developed that enables comprehensive evaluation of the regional quality of care of cross-indication, integrated care models focusing on common diseases. In order to be able to increasingly evaluate aspects of care coordination and patient orientation, health promotion as well as nursing, palliative and emergency care in the future, it would be helpful if routine data were collected or made accessible in these areas as well.