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.

[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.

[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.

[Cost and Revenue Relationship in Orthopaedic and Trauma Surgery Patients in Relation to Body Mass Index]. / Kosten-Erlös-Verhältnis orthopädisch-unfallchirurgischer Patienten in Abhängigkeit vom Body-Mass-Index.

BACKGROUND: Growing numbers of patients in orthopaedic and trauma surgery are obese. The risks involved are e.g. surgical complications, higher costs for longer hospital stays or special operating tables. It is a moot point whether revenues in the German DRG system cover the individual costs in relation to patients' body mass index (BMI) and in which area of hospital care potentially higher costs occur. MATERIAL AND METHODS: Data related to BMI, individual costs and revenues were extracted from the hospital information system for 13,833 patients of a large hospital who were operated in 2007 to 2010 on their upper or lower extremities. We analysed differences in cost revenue relations dependent on patients' BMI and surgical site, and differences in the distribution of hospital cost areas in relation to patients' BMI by t and U tests. RESULTS: Individual costs of morbidly obese (BMI ≥ 40) and underweight patients (BMI < 18.5) significantly (p < 0.05) exceeded individual DRG revenues. Significantly higher cost revenue relations were detected for all operations on the lower and upper extremities except for ankle joint surgeries in which arthroscopical procedures predominate. Most of the incremental costs resulted from higher spending for nursing care, medication and special appliances. Costs for doctors and medical ancillary staff did not increase in relation to patients' BMI. CONCLUSION: To avoid BMI related patient discrimination, supplementary fees to cover extra costs for morbidly obese or underweight patients with upper or lower extremities operations should raise DRG revenues. Moreover, hospitals should be organisationally prepared for these patients.

[Integrative and person-centred health care from a health system perspective]. / Integrative und personenzentrierte Gesundheitsversorgung aus der Perspektive des Gesundheitssystems.

OBJECTIVE: Many health-care systems are confronted on the one hand side with the challenge to meet care demands of a continuously aging population that suffers from multiple and chronic diseases and, on the other hand side, to adapt health-care services to the preferences of the population. We analyse whether the German health-care system already pursues the objective to deliver integrated, person-centred, interdisciplinary and interprofessional health-care services and which prospects 'integrated and person-centred health care' offers. METHOD: We performed a selective literature analysis. RESULTS: Different from the World Health Organisation or the Institute of Medicine, the German Social Code Book V does not pursue the objective of delivering person-centred health care. However, the introduction of integrated health-care services is explicitly enabled. Yet until now, only 10% of the population are encompassed by such health-care delivery concepts. Clear chances for integrated and person-centred health care exist, e. g., in reducing repeat diagnostic procedures, overcoming failures in communication and information exchange, and encouraging interprofessional health care delivery that up to now often encounter resistance of physicians. CONCLUSION: Legal provisions to reform the German health-care system in the direction of more integrative and person-centred health-care services are already partly in place. What is lacking is a broad implementation and evaluation of such a concept of health-care delivery that is advantageous for the system and preferred by the population.

[Quality management in implementing specialist pediatric palliative home care in Lower Saxony, Germany]. / Qualitätsmanagement bei der Einführung der Spezialisierten Ambulanten Pädiatrischen Palliativversorgung in Niedersachsen.

BACKGROUND: To provide comprehensive high-quality health care is a great challenge in the context of high specialisation and intensive costs. This problem becomes further aggravated in service areas with low patient numbers and low numbers of specialists. Therefore, a multidimensional approach to quality development was chosen in order to optimise the care of children and adolescents with life-limiting conditions in Lower Saxony, a German federal state with a predominantly rural infrastructure. METHODS: Different service structures were implemented and a classification of service provider's specialisation was defined on the basis of existing references of professional associations. Measures to optimise care were implemented in a process-oriented manner. RESULTS: High-quality health care can be facilitated by carefully worded requirements concerning the quality of structures combined with optimally designed processes. Parts of the newly implemented paediatric palliative care structures are funded by the statutory health insurance.

Placebo effect sizes in homeopathic compared to conventional drugs - a systematic review of randomised controlled trials.

BACKGROUND: It has been hypothesised that randomised, placebo-controlled clinical trials (RCTs) of classical (individualised) homeopathy often fail because placebo effects are substantially higher than in conventional medicine. OBJECTIVES: To compare placebo effects in clinical trials on homeopathy to placebo effects on trials of conventional medicines. METHODS: We performed a systematic literature analysis on placebo-controlled double-blind RCTs on classical homeopathy. Each trial was matched to three placebo-controlled double-blind RCTs from conventional medicine (mainly pharmacological interventions) involving the same diagnosis. Matching criteria included severity of complaints, choice of outcome parameter, and treatment duration. Outcome was measured as the percentage change of symptom scores from baseline to end of treatment in the placebo group. 35 RCTs on classical homeopathy were identified. 10 were excluded because no relevant data could be extracted, or less than three matching conventional trials could be located. RESULTS: In 13 matched sets the placebo effect in the homeopathic trials was larger than the average placebo effect of the conventional trials, in 12 matched sets it was lower (P=0.39). Additionally, no subgroup analysis yielded any significant difference. CONCLUSIONS: Placebo effects in RCTs on classical homeopathy did not appear to be larger than placebo effects in conventional medicine.

[The German program for disease management guidelines: evaluation by use of quality indicators]. / Nationale VersorgungsLeitlinien--Evaluation durch Qualitätsindikatoren.

The Program for National Disease Management Guidelines (German DM-CPG Program) in Germany aims at the implementation of best-practice recommendations for prevention, acute care, rehabilitation and chronic care in the setting of disease management programs and integrated health-care systems. Like other guidelines, DM-CPG need to be assessed regarding their influence on structures, processes and outcomes of care. However, quality assessment in integrated health-care systems is challenging. On the one hand, a multitude of potential domains for measurement, actors and perspectives need to be considered. On the other hand, measures need to be identified that assess the function of the diagnostic and therapeutic chain in terms of cooperation and coordination of care. The article reviews methods and use of quality indicators in the context of the German DM-CPG Program.