[Development of an indicator set for the evaluation of the quality of routine ambulatory health care for common disorders in children and adolescents]. / Entwicklung eines Indikatorensets zur Evaluation der Versorgungsqualität in der ambulanten Routineversorgung häufiger Erkrankungen des Kindes- und Jugendalters.

BACKGROUND: In Germany, no consented quality indicator set (QI set) exists to date that can be used to assess the quality of pediatric care. Therefore, the aim of the project "Assessment of the quality of routine ambulatory health care for common disorders in children and adolescents" (QualiPäd) funded by the Innovation Committee of the Federal Joint Committee (grant no.: 01VSF19035) was to develop a QI set for the diseases asthma, atopic eczema, otitis media, tonsillitis, attention-deficit hyperactivity disorder (ADHD), depression and conduct disorder. METHODS: For the observation period 2018/2019, quality indicators (QIs) were searched in indicator databases, guidelines and literature databases and complemented in part by newly formulated QIs (e.g., derived from guideline recommendations). The QIs were then assigned to content categories and dimensions according to Donabedian and OECD and reduced by removing duplicates. Finally, a panel of experts consulted the QIs using the modified RAND-UCLA Appropriateness Method (RAM). RESULTS: The search resulted in a preliminary QI set of 2324 QIs. After the reduction steps and the evaluation of the experts, 282 QIs were included in the QI set (asthma: 72 QIs, atopic eczema: 25 QIs, otitis media: 31 QIs, tonsillitis: 12 QIs, ADHD: 53 QIs, depression: 43 QIs, conduct disorder: 46 QIs). The QIs are distributed among the following different categories: Therapy (138 QIs), Diagnostics (95 QIs), Patient-reported outcome measures/Patient-reported experience measures (PROM/PREM) (45 QIs), Practice management (31 QIs), and Health reporting (4 QIs). In the Donabedian model, 89% of the QIs capture process quality, 9% outcome quality, and 2% structural quality; according to the OECD classification, 61% measure effectiveness, 23% patient-centeredness, and 16% safety of care. CONCLUSION: The consented QI set is currently being tested and can subsequently be used (possibly modified) to measure the quality of routine outpatient care for children and adolescents in Germany, in order to indicate the status quo and potential areas for improvement in outpatient care.

Process over outcome quality in paediatrics? An analysis of outpatient healthcare quality indicators for seven common diseases.

PURPOSE: The purpose of this study was to examine the scope, quality dimensions and treatment aspects covered by existing quality indicators (QIs) for the somatic diseases bronchial asthma, atopic eczema, otitis media and tonsillitis as well as the psychiatric disorders attention deficit hyperactivity disorder (ADHD), depression and conduct disorder in paediatrics. METHODS: QIs were identified through an analysis of the guidelines and a systematic search of literature and indicator databases. Subsequently, two researchers independently assigned the QIs to the quality dimensions according to Donabedian and Organisation for Economic Cooperation and Development (OECD) and to the content categories covering the treatment process. RESULTS: We found 1268 QIs for bronchial asthma, 335 QIs for depression, 199 QIs for ADHD, 115 QIs for otitis media, 72 QIs for conduct disorder, 52 QIs for tonsillitis and 50 QIs for atopic eczema. Of these, 78% focused on process quality, 20% on outcome quality and 2% on structural quality. Using OECD criteria, 72% of the QIs were assigned to effectiveness, 17% to patient-centredness, 11% to patient safety and 1% to efficiency. The QIs covered the following categories: diagnostics (30%), therapy (38%), patient-reported outcome measures/ observer-reported outcome measures/patient-reported experience measures (in sum 11%), health monitoring (11%) and office management (11%). CONCLUSION: Most QIs focused on the dimensions of effectiveness and process quality, and on the categories of diagnostics and therapy, with outcome-focused and patient-focused QIs being under-represented. Possible reasons for this striking imbalance could be the easier measurability and clearer assignment of accountability in comparison to the QIs of outcome quality, patient-centredness and patient safety. To produce a more balanced picture of the quality of healthcare, the future development of QIs should prioritise the currently under-represented dimensions.

Assessing the effect of a regional integrated care model over ten years using quality indicators based on claims data - the basic statistical methodology of the INTEGRAL project.

BACKGROUND: The regional integrated health care model "Healthy Kinzigtal" started in 2006 with the goal of optimizing health care and economic efficiency. The INTEGRAL project aimed at evaluating the effect of this model on the quality of care over the first 10 years. METHODS: This methodological protocol supplements the study protocol and the main publication of the project. Comparing quality indicators based on claims data between the intervention region and 13 structurally similar control regions constitutes the basic scientific approach. Methodological key issues in performing such a comparison are identified and solutions are presented. RESULTS: A key step in the analysis is the assessment of a potential trend in prevalence for a single quality indicator over time in the intervention region compared to the corresponding trends in the control regions. This step has to take into account that there may be a common - not necessarily linear - trend in the indicator over time and that trends can also appear by chance. Conceptual and statistical approaches were developed to handle this key step and to assess in addition the overall evidence for an intervention effect across all indicators. The methodology can be extended in several directions of interest. CONCLUSIONS: We believe that our approach can handle the major statistical challenges: population differences are addressed by standardization; we offer transparency with respect to the derivation of the key figures; global time trends and structural changes do not invalidate the analyses; the regional variation in time trends is taken into account. Overall, the project demanded substantial efforts to ensure adequateness, validity and transparency.

Assessment of the quality of routine ambulatory healthcare for common disorders in children and adolescents in Germany: study protocol for a retrospective medical record review (QualiPäd).

INTRODUCTION: The quality of healthcare in childhood and adolescence is of key importance, in order to foster a healthy development and to avoid chronic health problems. Yet, data for Germany regarding the quality of healthcare for this patient group are lacking. The QualiPäd research project aims to estimate the quality of outpatient healthcare for children and adolescents in Germany, focusing on common psychiatric and physical disorders. METHODS AND ANALYSIS: Quality indicators for seven common physical and mental childhood and adolescent clinical conditions (attention deficit/hyperactivity disorder, asthma, atopic dermatitis, depression, otitis media, conduct disorder/oppositional defiant disorder, tonsillitis) will be developed and ratified by experts, using the RAND/UCLA Appropriateness Method.Initially, 1400 medical records of children and adolescents with one of the aforementioned clinical conditions will then be randomly drawn from 40 outpatient practices in the German federal state of Hessen. The records will then be assessed regarding their adherence to the respective quality indicators. Based on this, the percentage of appropriate and inappropriate (eg, wasteful) healthcare of all clinical conditions (primary endpoint) will be estimated. Additionally, possible factors influencing the quality of care (eg, patient characteristics, type of condition, type of practice) will be identified using generalised estimation equation models. ETHICS AND DISSEMINATION: This study will show for which of the studied clinical conditions and/or patients improvement of quality of care is necessary within the German health system. Also, the quality indicators designed for the study can afterwards be implemented in regular care and thus enable regular reporting of the outpatient care of this target group. The authors plan to disseminate their findings through international, peer-reviewed scientific publications, and through presentations at national and international paediatric and child psychiatric conferences. TRIAL REGISTRATION NUMBER: DRKS00022408.

[Operationalization of Quality Indicators with Routine Data Using the Example of the Evaluation of "Integrated Care Healthy Kinzigtal"]. / Operationalisierung von Qualitätsindikatoren mittels Routinedaten am Beispiel der Evaluation der "Integrierten Versorgung Gesundes Kinzigtal".

AIM: As part of the 10-year evaluation of Gesundes Kinzigtal Integrated Care (IVGK, Innovation Fund Project 01VSF16002), a multidisciplinary group of experts agreed on 101 quality indicators (QI) to evaluate the quality of regionally integrated care with its focus on health and prevention programs. One criterion was that the selected QI should in principle be suitable for mapping using routine data. The aim of the study was to investigate how many and in what way the QI developed can actually be mapped in Germany with routine data and for what reasons operationalization was restricted or not possible. MATERIAL AND METHODS: The operationalization of the QIs was performed using pseudonymized billing data of the AOK Baden-Württemberg from 2006 to 2015, which the Scientific Institute of the AOK (WIdO) provided to the evaluation team. All operationalized indicators were binary coded (criterion fulfilled yes/no). The diagnoses, procedures, or drugs named in the numerator and denominator definitions were operationalized using ICD-10 codes (inclusion and exclusion diagnoses), EBM codes, OPS codes, ATC codes. Indicator prevalences were examined over time to check for abnormalities as an indication of possible misscoding. RESULTS: Ninety of the 101 indicators were operationalizable with routine data. Fourteen of the 90 indicators could only be operationalized with restrictions, as corresponding service codes were only introduced or existing codes were changed during the observation period. Seventy-six of 90 indicators could be operationalized without restrictions. In this context, 15 of these 76 indicators required pre- and follow-up periods, which meant that they could not be presented for all years. Eleven of 101 QIs could not be operationalized because EBM codes were only introduced after 2015 or were not recorded as individual services for all physician groups (e. g., spirometry and long-term ECG). Striking trends in indicator prevalences could be explained. CONCLUSION: Routine data enable resource-saving quality monitoring. A change in the data basis during the observation period, for example through the introduction or deletion of billing codes, makes the longitudinal, routine data-based quality assessment more difficult, but enables further or new indicators to be operationalized for later periods.

Ten-Year Evaluation of the Population-Based Integrated Health Care System "Gesundes Kinzigtal".

BACKGROUND: The population-based integrated health care system called "Gesundes Kinzigtal" (Integrierte Versorgung Gesundes Kinzigtal, IVGK) was initiated more than 10 years ago in the Kinzig River Valley region, which is located in the Black Forest in the German state of Baden-Württemberg. IVGK is intended to optimize health care while maximizing cost-effectiveness. It consists of programs for promoting health and for enabling cooperation among service providers, as well as of a shared-savings contract that has enabled resources to be saved every year. The goal of the present study was to investigate trends in the quality of care provided by IVGK over the past ten years in comparison to conventional care. METHODS: This is a non-randomized observational study with a control-group design (Kinzig River Valley versus 13 structurally comparable control regions), employing data collected by AOK, a large statutory health-insurance provider in Germany, over the period 2006-2015. Quality assessment was conducted with the aid of a set of indicators, developed by the authors, that was based exclusively on claims data. The statistical analysis of the trends in these indicators over time was conducted with preset criteria for the relevance of any observed changes, as well as preset mechanisms of controlling for confounding factors. RESULTS: For 88 of the 101 evaluable indicators, no relevant difference was seen between the trend over time in the region of the intervention and the average trend in the control regions. Relevant differences in favor of the IVGK were observed for six indicators, and negatively divergent trends compared to the controls were observed for seven indicators. In the main summarizing statistical analysis, no positive or negative difference was found between the Kinzig River Valley and the other regions with respect to trends in the health-care indicators over time. CONCLUSION: An evaluation based on 101 indicators derived from health-insurance data did not reveal any improvement of the quality of care by IVGK and the totality of the programs that were implemented under it. However, under the conditions of the shared-savings contract, no relevant diminution in the quality of care was observed over a period of 10 years either, compared with structurally similar control regions without an integrated care model.

[Patient safety in ambulatory care: Development and application of a CATI questionnaire (PSP-AMB) to capture patient safety problems from the perspective of patients aged 40 years and older]. / Patientensicherheit in der ambulanten Versorgung - Entwicklung und Anwendung eines CATI-Fragebogens (PSP-AMB) zur Erfassung patientensicherheitsrelevanter Probleme aus der Perspektive von Patient*innen ≥40 Jahre.

BACKGROUND: The epidemiology of patient safety problems (PSPs) in the German ambulatory care sector is largely unknown. So far, there has been a lack of appropriate survey instruments. OBJECTIVE: Development and application of a questionnaire (PSP-AMB), which records the epidemiology of PSP in the ambulatory care sector from the patient's perspective by using computer-assisted telephone interviews (CATI) on a population sample of ≥40-year-olds. METHODS: The questionnaire items were developed by means of a literature search and guided interviews with ambulatory care physicians (N=10) and patients (N=20). The conversion to CATI and its application in the field was carried out by a survey institute. Qualitative (N=20) and quantitative (N=110) pretests were conducted before going into the field. The sample was generated via randomly generated fixed and mobile telephone numbers. RESULTS: PSP-AMB collects 32 PSPs in seven areas of medical treatment, from medical history-taking to practice organisation, and surveys all PSPs from the last 12 months (PSP-one-year incidence), PSPs with harm since the age of 40 (PSP-40+-prevalence), as well as PSPs resulting in death or severe need for care via proxy survey of the participants' parents and children. Detailed questions record the consequences and handling of PSPs and participants' socio-demographic data. Between May and October 2018, a total of 10,037 citizens (participation rate: 12.4%) were interviewed. The drop-out rate was 8.3%. The sample represents the German population aged 40 years or older. DISCUSSION: PSP-AMB is suitable for systematically recording PSPs in the ambulatory care sector from the patient's perspective. Thus, PSP-AMB meets the international demand to actively involve patients as a valuable source of information to improve patient safety.

[Implementation of Continuity of Care in Everyday Care - A Comparison Between two Psychiatric Hospitals]. / Umsetzung von Behandlungskontinuität im Versorgungsalltag ­ ein Vergleich zwischen zwei psychiatrischen Kliniken 1.

OBJECTIVE: The rigid separation of outpatient and inpatient care in the German health care system prevents continuity of care, although it has been shown to be of great importance for psychiatric patients. This study analyzes continuity of care of a model hospital with a global treatment budget according to §â€Š64b SGB V and constant treatment staff across all settings in comparison to a control hospital with regular financing without such a team. METHODS: In a prospective cohort study with a 20-month observation period, we collected data on continuity of care of 220 model and 215 control clinic patients. RESULTS: The model clinic achieved significant higher continuity of care than the control clinic, both during inpatient treatment at the time of recruitment and across all settings during the observation period. CONCLUSION: A global treatment budget can create the necessary conditions for more flexible psychiatric care and better implementation of continuity of care.

[Development of an indicator set for the evaluation of the population-based integrated healthcare model 'Gesundes Kinzigtal' (Healthy Kinzigtal)]. / Entwicklung eines Indikatorensets zur Evaluation der Integrierten Versorgung Gesundes Kinzigtal.

INTRODUCTION: The 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. METHODS: RESULTS: The 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. DISCUSSION: The 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. CONCLUSION: On 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.

Study protocol for a quasi-experimental claims-based study evaluating 10-year results of the population-based integrated healthcare model 'Gesundes Kinzigtal' (Healthy Kinzigtal): the INTEGRAL study.

INTRODUCTION: Patients often experience interface problems when treated by different specialists and in different healthcare sectors. Integrated care concepts aim to reduce these problems. While most integrated healthcare models focus on individual diseases, the integrated care model 'Gesundes Kinzigtal' applies a population-based approach and addresses the full spectrum of morbidities for a population defined by area of residence-the Kinzigtal. A special feature of the model is the joint savings contract between the regional management company and the statutory health insurers. The INTEGRAL study aims at assessing the effectiveness of 'Gesundes Kinzigtal' under routine conditions in comparison to conventional care over a period of 10 years in order to understand the benefits but also the potential for (unintended) harms. METHODS AND ANALYSIS: Database Claims data from statutory health insurance funds 2005-2015. The evaluation consists of a quasi-experimental study, with Kinzigtal as intervention region, at least 10 further regions with a similar population and healthcare infrastructure as primary controls and an additional random sample of insurees from the federal state of Baden-Württemberg as secondary controls. Model-specific and 'non-specific' indicators adopted from the literature and enriched by focus group interviews will be used to evaluate the model's effectiveness and potential unintended consequences by analysing healthcare utilisation in general. Temporal trends per indicator in the intervention region will be compared with those in each control region. The overall variation in trends for the indicators across all regions provides information about the potential to modify an indicator due to local differences in the healthcare system. ETHICS AND DISSEMINATION: Ethic Commission of the Faculty of Medicine, Philipps-University Marburg (ek_mr_geraedts_131117). Results will be discussed in workshops, submitted for publication in peer-review journals and presented at conferences. TRIAL REGISTRATION NUMBER: DRKS00012804.