[Does the Innovation Fund Improve Healthcare Provision? A Critical Assessment of the Status of Implementing Successful Innovation Fund Projects into Healthcare Practice]. / Verbessert der Innovationsfonds die Versorgung? Eine kritische Bestandsaufnahme zum Stand der Implementierung erfolgreicher Innovationsfondsprojekte in die Versorgungspraxis.

INTRODUCTION: Since 2015, the Federal Joint Committee (G-BA)'s Innovation Fund has been supporting projects in health services research and new health service models ("Neue Versorgungsformen", NVF). By the end of 2022, 211 projects in the NVF category had been funded. A key objective is the transfer of successful projects into standard care. This article analyzes previous projects regarding their incorporation into routine care based on transfer recommendations of the Innovation Fund Committee ("Innovationsausschuss" IA). METHOD: Descriptive analysis of all projects completed by August 1, 2023 with transfer recommendations in the "NVF" funding stream. Presentation by topic, project duration, time until IA transfer decision, categorization, and number of institutions and organizations (recipients) addressed per project, their feedback published on the G-BA website, response rates per recipient group, and a content classification and interpretation of exemplary feedback. Recommendations based on the results and their discussion in an expert workshop. RESULTS: Out of 57 NVF projects, 17 had a transfer recommendation. A total of 57 feedback responses were received from a total of 431 recipients addressed by the IA across these projects. Response rates varied significantly. One-third of inquiries to the G-BA and its member organizations received a response (31%), while only every fifth inquiry to federal states (18%) and professional societies (18%) got a response. Less than one in ten inquiries to the Federal Ministry of Health (8%), administrative bodies (6%), and the German Medical Association (0%) received a response. Project-specific feedback within a recipient group was often contradictory or limited to regional scope. DISCUSSION AND CONCLUSION: The transfer process reveals significant structural and procedural obstacles regarding the incorporation of projects evaluated as successful into routine health care. To ensure that funding from the innovation fund is most effectively used, there needs to be a realistic chance of successful transfer of positive project outcomes into routine care. The DNVF recommends stronger involvement of rule-competent institutions, mandatory publication of responses, structured moderation of the transfer process, expanding types of selective contracts, financing of implementation phases and of studies drawing on results across successful NVF projects.

Association between continuity of care and treatment outcomes in psychiatric patients in Germany: a prospective cohort study.

BACKGROUND: Continuity of care is considered an important treatment aspect of psychiatric disorders, as it often involves long-lasting or recurrent episodes with psychosocial treatment aspects. We investigated in two psychiatric hospitals in Germany whether the positive effects of relational continuity of care on symptom severity, social functioning, and quality of life, which have been demonstrated in different countries, can also be achieved in German psychiatric care. METHODS: Prospective cohort study with a 20-months observation period comparing 158 patients with higher and 165 Patients with lower degree of continuity of care of two psychiatric hospitals. Patients were surveyed at three points in time (10 and 20 months after baseline) using validated questionnaires (CGI Clinical Global Impression rating scales, GAF Global Assessment of Functioning scale, EQ-VAS Euro Quality of Life) and patient clinical record data. Statistical analyses with analyses of variance with repeated measurements of 162 patients for the association between the patient- (EQ-VAS) or observer-rated (CGI, GAF) outcome measures and continuity of care as between-subject factor controlling for age, sex, migration background, main psychiatric diagnosis group, duration of disease, and hospital as independent variables. RESULTS: Higher continuity of care reduced significantly the symptom severity with a medium effect size (p 0.036, eta 0.064) and increased significantly social functioning with a medium effect size (p 0.023, eta 0.076) and quality of life but not significantly and with only a small effect size (p 0.092, eta 0.022). The analyses of variance suggest a time-independent effect of continuity of care. The duration of psychiatric disease, a migration background, and the hospital affected the outcome measures independent of continuity of care. CONCLUSION: Our results support continuity of care as a favorable clinical aspect in psychiatric patient treatment and encourage mental health care services to consider health service delivery structures that increase continuity of care in the psychiatric patient treatment course. In psychiatric health care services research patients' motives as well as methodological reasons for non-participation remain considerable potential sources for bias. TRIAL REGISTRATION: This prospective cohort study was not registered as a clinical intervention study because no intervention was part of the study, neither on the patient level nor the system level.

COVID-19 risks in private equity nursing homes in Hesse, Germany - a retrospective cohort study.

BACKGROUND: Private-equity-owned nursing homes (PENH) represent the strongest form of profit orientation in the nursing care market. Private equity firms aim to increase the profitability of nursing care facilities, which often leads to cost-cutting measures and the use of less qualified staff. Our study aims to fill the existing knowledge gap by examining the association between private equity ownership and COVID-19 related infections and deaths among residents and staff during the COVID-19 pandemic. METHODS: We analyzed outbreak and mortality data for the period from 20/03/2020 to 05/01/2022 from 32 long-term care facilities in the Federal State of Hesse, Germany, which included 16 PENH that were propensity score matched on regional population density and number of beds with 16 non-PENH. We used logistic regression to determine the odds ratios (OR) for above-median values for the independent variables of PENH-status, number of beds, proportion of single rooms, registered nurses' ratio, and copayments. RESULTS: PENH had substantially fewer outbreaks in number, but longer and larger outbreaks among nursing home residents, as well as a markedly increased proportion of deceased residents. The odds of the outcome "infections & deaths" were 5.38 (p <. 05) times higher among PENH compared to non-PENH. CONCLUSIONS: The study indicates a need for further research into the quality of care in PENH to inform evidence-based policy decisions, given the higher infection and death rates. Improved documentation and public visibility of PENH is also recommended, in line with existing practices for for-profit and non-profit nursing homes in Germany. Given our findings, regulatory bodies should closely observe PENH operational practices.

Potential determinants of the quantity and duration of COVID-19 outbreaks in geriatric long-term care facilities.

BACKGROUND: We analyzed potential factors for the number and duration of COVID-19 outbreaks in nursing homes based on routine and structural data. METHODS: All outbreaks during 03/2020-01/2022 in N = 687 of a total of 879 geriatric long-term care facilities (LTCFs) in the Federal State of Hesse, Germany were analyzed using t-tests and logistic regressions in a retrospective cohort study. RESULTS: Larger LTCFs have more (+ 1.57, p = .009) and longer outbreaks (+ 10.04 days, p > .001). A higher proportion of registered nurses reduces the number (-0.1, p = .036) and duration (-6.02 days, p > .001) of outbreaks. Single-bed rooms provide less duration of outbreaks (-4.5, p = .004). A higher proportion of infected residents (+ 24.26 days, p < .001) and staff (+ 22.98 days, p < .001) prolong outbreaks the most. LTCFs in areas with intermediate population density have an increased risk of prolonged outbreaks (OR: 1.537, p = .036). CONCLUSIONS: To prevent outbreaks and shorten their duration, LTCFs should increase the proportion of registered nurses and single-bed rooms, and control staff infections.

[Specialization of Acute Stroke Care in Germany: Structural Changes During 2006-2017]. / Spezialisierung der Schlaganfallversorgung in Deutschland: Strukturveränderungen im Zeitraum von 2006­2017.

HINTERGRUND: Um die Schlaganfallversorgung zu optimieren, wurden in Deutschland in den letzten Jahren verschiedene qualitätsfördernde Maßnahmen (qfM) in regional unterschiedlichem Maß eingeführt. Ob sich diese Maßnahmen über die Jahre flächendeckend etabliert haben, ist unklar. METHODE: Für die strukturbezogenen Analysen der Schlaganfallversorgung in Deutschland wurden alle relevanten dokumentierten Schlaganfälle (ICD-10) aus den Qualitätsberichten (QB) deutscher Krankenhäuser und eine repräsentative Stichprobe von Krankenversicherungsdaten (AOK) im Zeitraum von 2006 (QB)/2007 (AOK) bis 2017 verwendet. Diese Informationen wurden u. a. durch Angaben zu zertifizierten Stroke Units der Deutschen Schlaganfall-Gesellschaft (DSG) und Daten zur Führung von regionalen Schlaganfall-Registern der Arbeitsgemeinschaft Deutschsprachiger Schlaganfall-Register (ADSR) ergänzt. Zur Verfolgung der Veränderungen des Versor-gungsgeschehens im deutschen Bundesgebiet wurden die Daten mit geografischen Daten (Bundesamt für Kartographie und Geodäsie) verknüpft. Es erfolgten univariate Analysen der Daten und eine Trend-Analyse der verschiedenen qfM im Jahresverlauf (Konkordanzkoeffizient nach Kendall). ERGEBNISSE: Die QB Analysen zeigten einen Anstieg kodierter Schlaganfälle in Krankenhäusern mit qfM um 14-20%. In 2006 wurden 80% der Schlaganfälle (QB) in einem Krankenhaus mit min. einer qfM kodiert, in 2017 95%. Diese Entwicklungen spiegelten sich auch in den AOK-Routinedaten wider, wobei in 2007 89% und in 2017 97% der Patient:innen unter mindestens einer qfM behandelt wurden. Dabei waren in 2007 bei 55% der behandelnden Krankenhäuser qfM vorhanden, in 2017 bei 72%. SCHLUSSFOLGERUNG: Patient:innen werden inzwischen signifikant häufiger in Krankenhäusern mit Spezialisierung auf die Schlaganfallversorgung behandelt. Auch die verschiedenen qfM haben sich im Laufe der Jahre im gesamten Bundesgebet verbreitet, jedoch existieren noch Versorgungslücken, die geschlossen werden sollten, damit in Zukunft alle Patient:innen qualitativ hochwertig behandelt werden können. BACKGROUND: In order to optimize stroke care, various quality-enhancing measures (qfM) have been introduced in Germany in recent years to varying degrees across regions, with the aim of achieving the best possible quality of care. It is unclear whether these measures have become established nationwide over the years. METHOD: For the structural analyses of stroke care in Germany, all relevant documented strokes (ICD-10) from the quality reports (QB) of German hospitals and a representative sample of health insurance data (AOK) for the period from 2006 (QB)/2007 (AOK) to 2017 were used. This information was supplemented by data on certified stroke units from the German Stroke Society (DSG) and data on the maintenance of regional stroke registries from the Working Group of German-Speaking Stroke Registers (ADSR), among others. To track changes in patterns of care in Germany, the data were linked with geographic data (Federal Agency for Cartography and Geodesy). Univariate analyses of the data and a trend analysis of the different qfM over the year (Kendall concordance coefficient) were performed. RESULTS: The analyses (QB) showed an increase in coded strokes in hospitals with qfM between 14-20%. In 2006, 80% of strokes (QB) were coded in hospitals with at least one qfM and 95% in 2017. Comparing years, AOK data showed similar trends: in 2007, 89% of patients were treated in hospitals with at least one qfM and 97% in 2017. In 2007, 55% of treating hospitals had qfM and 72% in 2017. CONCLUSION: Meanwhile, patients are more often treated in hospitals that specialise in stroke care. In addition, the various qfM have spread across the nation over the years, but there are still gaps in care that should be addressed to ensure quality care for all patients in the future.

[Routine Practice Data for Health Care Analyses: Part 3 of the Manual]. / Versorgungsnahe Daten für Versorgungsanalysen ­ Teil 3 des Manuals.

Analyses of health and health care (hereafter referred to as "health care analyses") usually aim to make transparent the structures, processes, results and interrelationships of health care and to record the degree to which health care systems and their actors have achieved their goals. Health care-related data are an indispensable source of data for many health care analyses. A prerequisite for the examination of a degree of goal achievement is first of all an agreement on those goals that are to be achieved by the system and its substructures, as well as the identification of the determinants of the achievement of the objectives. Primarily it must be examined how safely, effectively and patient-centred systems, facilities and service providers are operating. It also addresses issues of need, accessibility, utilisation, timeliness, appropriateness, patient safety, coordination, continuity, and health economic efficiency and equity of health care. The results of health care include system services (outputs), on the one hand, and results (outcomes), on the other, whereby the results (patient-reported outcomes) and experiences (patient-reported experiences) reported are of particular importance. Health care analyses answer basic questions of health care research: who does what, when, how, why and with which resources and effects in routine health care. Health care analyses thus provide the necessary findings and key figures to further develop health care in order to improve the quality of health care. The applications range from capacity analyses to following innovations up to the concept of regional and supra-regional monitoring of the quality of care given to the population. Given the progress of digitalisation in Health Care, direct data from the care processes will be increasingly available for health care research. This can support care givers significantly if the findings of the studies are applied precisely and correctly within an adequate methodological frame. This can lead to measurable improved health care quality for patients. Data from the process of health care provision have a high potential. Their use needs the same scientific scrutiny as in all other scientific studies.

Associations between structure- and process-orientated measures and stroke long term mortality - an observational study based on routine data.

OBJECTIVES: Various measures are used to improve the quality of stroke care. In Germany, these include concentrating treatment in specialized facilities (stroke units), mandatory quality comparisons of hospitals in some German states, and treatment according to prespecified structure and process specifications (neurological complex treatment 8-981 or 8-98b). These measures have previously only been analyzed individually and regarding short-term patient outcomes. This study analyzes these measures in combination, considering patients' comorbidities as well as stroke severity in a longitudinal perspective. MATERIALS/METHODS: Analyses were based on data from 243,415 insurees of Germany's biggest health insurance (AOK) admitted to hospitals between 2007 and 2017 with cerebral infarction. Mortality risk was calculated using Cox regressions adjusted for various covariates. Kaplan-Meier analyses were differentiated by treatment site (stroke unit/external quality assurance/ Federal State Consortium of Quality Assurance Hesse - LAGQH) were performed, followed by log-rank tests and p-value adjustment. Trend analyses were performed for treatment types in combination with treatment sites. RESULTS: All analyses showed significant advantages for patients who received Neurological Complex Treatment, especially when the treatment was performed under external quality assurance conditions and/or in stroke units. There was an increasing frequency of specialized stroke treatment. CONCLUSIONS: Quality-enhancing structures and processes are associated with a lower mortality risk after stroke. There appears to be evidence of a cascading benefit from the implementation of neurological complex treatment, external quality assurance, and ultimately, stroke units. Consecutively, care should be concentrated in hospitals that meet these specifications. However, since measures are often applied in combination, it remains unclear which specific measures are crucial for patient outcome.

[How do Surgical Patients Choose their Hospital? A Cross-sectional Study]. / Wie wählen chirurgische Patienten ihr Krankenhaus? Eine Querschnittstudie // How do surgical patients choose their hospital? A cross-sectional study.

BACKGROUND: Free hospital choice is promoted in health policy through public quality reporting. Previous studies on hospital choice mostly survey patients for specific elective procedures. This study examines all full inpatient surgical patients and compares them to those in other specialties. Research questions are: How many patients make their own decisions about the hospital? How much time do they have before admission? Where do they obtain information and what are their important decision criteria? MATERIALS AND METHODS: This study evaluates cross-sectional primary data on hospital choice collected by questionnaire from 1925 consecutively hospitalised patients from 11 medical specialties and 3 levels of care, including 438 surgical patients from 6 general surgery departments. RESULTS: Three quarters of surgical patients decide on the hospital themselves. Their own previous experience with the hospital is an important source of information and decision-making criterion for a good half of the patients, along with relatives and outpatient treatment providers as well as the hospital reputation. CONCLUSION: Many surgical patients decide in favour of a hospital because of the trust they have built up through previous treatment in the hospital, which they experience as satisfactory. The professional quality of treatment is thus the greatest impact factor on patients, their relatives and outpatient treatment providers. It is important to actively and specifically address and clarify possible dissatisfaction on the part of the patient before discharge.

[People with intellectual disabilities (ID) in outpatient medical care: barriers to access and treatment process]. / Menschen mit geistiger Behinderung (MmgB) in der ambulanten medizinischen Versorgung: Barrieren beim Zugang und im Untersuchungsablauf.

BACKGROUND AND AIM: People with intellectual disabilities (ID) show an increased morbidity. Their access to healthcare could be a contributing factor, but there is little data on this in Germany. This paper addresses the question of what barriers and facilitators exist in the use of medical outpatient healthcare for people with ID, considering their own perspective and the perspectives of their accompanying relatives and their general practitioners (GPs). METHODS: In this cross-sectional study, people with ID in three sheltered workshops, their relatives and their GPs were interviewed by means of questionnaires. The data were evaluated descriptively, and a statistical comparison of the perspectives of the people with ID and their relatives was performed. The content structure follows Cantrell's pathway model (identifying need, accessing services and interaction during a consultation). RESULTS: People with ID communicate complaints to their relatives, who usually accompany them to medical appointments. There are more organisational than spatial barriers. The treatment is sometimes impeded by fears, restlessness or not allowing examinations. It is difficult to find experienced health professionals, which is why a list of such practices and, structurally, medical centres for people with ID would be beneficial. The views of people with ID and their relatives show hardly any differences. GPs cite increased treatment effort, desire for further training and appropriate remuneration. CONCLUSIONS: Relatives play an important role in the medical care of people with ID. Difficulties in care can arise from the specific, more complex requirements in treating people with ID, which present as organisational difficulties but also require an active readiness for inclusion.

Long-term outcomes of stroke unit care in older stroke patients: a retrospective cohort study.

BACKGROUND: older patients are less frequently treated in stroke units (SUs). Clinicians do not seem convinced that older patients benefit from specialised treatment in SU similarly to younger patients. OBJECTIVE: our study aimed to compare older patients' long-term outcomes with and without SU treatment. METHODS: this study used routinely collected health data of 232,447 patients admitted to hospitals in Germany between 2007 and 2017 who were diagnosed with ischaemic stroke (ICD 10 I63). The sample included 29,885 patients aged ≥90 years. The outcomes analysed were 10-, 30- and 90-day, and 1-, 3- and 5-year mortality and the combinations of death or recurrence, inpatient treatment and increase in long-term care needs. Bivariate chi-square tests and multivariable logistic regression analyses were used, adjusting for the covariates age, sex, co-morbidity, long-term care needs before stroke and socioeconomic status of the patients' region of origin. RESULTS: between 2007 and 2017, 57.1% of patients aged <90 years and 49.6% of those aged ≥90 years were treated in a SU. The 1-year mortality rate of ≥90-year-olds was 56.9 and 61.9% with and without SU treatment, respectively. The multivariable-adjusted risk of death in ≥90-year-olds with SU treatment was odds ratio (OR) = 0.67 (95% confidence interval [CI] = 0.62-0.73) 10 days after the initial event and OR = 0.76 (95% CI = 0.71-0.82) 3 years after stroke. CONCLUSIONS: even very old patients with stroke benefit from SU treatment in the short and long term. Therefore, SU treatment should be the norm even in older patients.

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.

[Association of Structural Variables with Quality of Care in German Hospitals]. / Assoziation von Strukturvariablen mit der Versorgungsqualität der Krankenhäuser in Deutschland.

BACKGROUND: The Hospital sector in Germany is undergoing uncoordinated structural changes for financial reasons. At the same time, quality-oriented control measures are used to ensure and improve the quality of treatment. It is unclear whether the right structures, namely those that guarantee positive results, will be maintained. OBJECTIVE: Investigation of the association between different structural hospital characteristics with quality of care. METHODS: In a secondary data analysis, the association of quality of care and the structural characteristics of hospital size, type of ownership, region, teaching status and case mix index (CMI) were compared based on hospital quality reports. Quality indices were calculated for each hospital using selected quality indicators of external quality assurance (eQA). First, the associations were examined univariately using the Mann-Whitney U test or Kruskal-Wallis test and then using multiple linear regression analysis, taking into account the interaction effects of the independent variables. FINDINGS: About 90% of the indices examined showed significant associations between structural hospital characteristics and the quality of care. Positive associations with the quality of care were found in the structural characteristics of hospital size of less than 100 beds, private ownership, no teaching hospital and a low CMI. Negative associations were observed in the structural variables hospital size more than 500 beds, public ownership, teaching-status and higher CMI. CONCLUSION: According to the results of this study, small hospitals seem to provide the best quality of care. This counterintuitive result suggests that the examined eQA quality indicators used in the index calculation may not be sufficiently risk-adjusted or scientifically evaluated, and their use as quality management tools is not recommended.

[Health Care Use by Intellectually Disabled People: A Cross-Sectional Study in three Sheltered Workshops]. / Inanspruchnahme der gesundheitlichen Versorgung von Menschen mit geistiger Behinderung, eine Querschnittstudie in 3 Werkstätten.

STUDY OBJECTIVE: People with intellectual disabilities have a lower life expectancy and more frequent comorbidities than the general population and have unmet health needs. Insufficient medical care is suspected to be one reason, for which little data is available in Germany. The study therefore focuses on the question of how people with intellectual disabilities make use of medical care, including screening and preventive measures. METHOD: In a cross-sectional study in 3 workshops for people with intellectual disabilities, the use of health care was surveyed by means of questionnaires from their relatives. The evaluation was carried out descriptively and by means of inferential statistics comparing participants with the general population as well as within the group of participants for socio-demographic differences. RESULTS: Almost all 181 participants (participation rate 19.3%) had a family doctor. In comparison to the general population, the participants made more frequent use of the services of general practitioners and the care provided by numerous other specialist areas. They made less frequent use of screening for colon, breast, cervix and prostate and more frequent use for skin cancer and general check-up. Dental check-ups and preventive measures showed no difference. Participants living in institutional settings made more use of the regular services than those living with relatives or alone. Participants with a migration background were less aware of care services. CONCLUSIONS: The results do not show any indications of a general undersupply of health care. Participation in cancer screening with more complex examinations should be encouraged, especially for people with mental disabilities living alone or with relatives. Those with a migration background and their families should be specifically informed.

[Effects of statutory quality assurance in acute inpatient care]. / Effekte der gesetzlichen Qualitätssicherung in der akutstationären Versorgung.

BACKGROUND: Statutory quality assurance (QA) serves to ensure and further develop the quality of service provision. Particularly prominent in Germany's acute inpatient care are mandatory quality reports (QRs) and participation in external quality assessments (eQAs). Their effects have not yet been comprehensively evaluated. OBJECTIVES: What are the effects of eQAs and QRs on the quality of care? MATERIALS AND METHODS: Based on a selective literature review, international evidence on the effects of QA was compiled. This was supplemented by analyses of the quality reports of the Federal Office for Quality Assurance (BQS), the Institute for Applied Quality Improvement and Research in Health Care (AQUA), and the Institute for Quality Assurance and Transparency in Healthcare (IQTIG), which have been responsible for eQAs since 2001. RESULTS: According to international literature, at most weak effects of these measures can be expected, especially on process quality. Studies from Germany mostly observe only uncontrolled temporal trends and partly show improved quality indicators. Only one controlled study each was able to show weak positive effects on outcome and process quality for eQAs and QRs, respectively. CONCLUSIONS: There are no convincing evaluation results for either the QRs or the eQAs. Deficiencies in the addressee-oriented design of the QRs and the reported indicator results in terms of their validity, risk adjustment, and temporal availability can be cited as potential causes. Statutory QA should be revised by paying more attention to the prerequisites for successful performance feedback and by again creating room for an intrinsically motivated assessment of one's own quality of care.

[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.

[Characteristics of Innovation Fund-supported Intervention Studies: Review and Document Analysis of Study Protocols, Publications and Final Reports]. / Charakteristika von durch den Innovationsfonds geförderten Interventionsstudien: Review und Dokumentenanalyse von Studienprotokollen, Publikationen und Abschlussberichten.

This prospectively registered review characterizes 50 intervention studies from the 1st wave of the Innovation Fund based on study protocols or original articles, among other sources. The mainly (randomized) controlled intervention studies included predominantly adults/seniors in ambulatory care without a regional focus and analyzed treatment processes, clinical and patient outcomes as outcomes. The substantial lack of study protocols and methodological details (e. g., sample size planning) reveals (avoidable) methodological problems regarding the scientific quality of the funded studies.

Impact of suspending minimum volume requirements for knee arthroplasty on hospitals in Germany: an uncontrolled before-after study.

BACKGROUND: In 2004, the Federal Joint Committee, supreme decision-making body in German healthcare, introduced minimum volume requirements (MVRQs) as a quality instrument. Since then, MVRQs were implemented for seven hospital procedures. This study evaluates the effect of a system-wide intermission of MVRQ for total knee arthroplasty (TKA), demanding 50 annual cases per hospital. METHODS: An uncontrolled before-after study based on federal-level data including the number of hospitals performing TKA, and TKA cases from the external hospital quality assurance programme in Germany (2004-2017). Bi- and multivariate analyses based on hospital-level secondary data of TKA cases and TKA quality indicators extracted from hospital quality reports in Germany (2006-2014). RESULTS: The number of TKAs performed in Germany decreased by 11% after suspending the TKA-MVRQ in 2011, and rose by 13% after its reintroduction in 2015. The number of hospitals with less than 50 cases rose from 10 to 25% and their case share from 2 to 5.5% during suspension. Change in hospital volume after the suspension of TKA-MVRQ was not associated with hospital size, ownership, or region. All four evaluable quality indicators increased significantly in the year after their first public reporting. Compared to hospitals meeting the TKA-MVRQ, three indicators show slight but statistically significant better quality in hospitals below the TKA-MVRQ. CONCLUSIONS: In Germany, TKA-MVRQs seem to induce in-hospital caseload adjustments rather than foster regional inter-hospital case transfers as intended.

[Manual for Methods and Use of Routine Practice Data for Knowledge Generation]. / Manual für Methoden und Nutzung versorgungsnaher Daten zur Wissensgenerierung.

" There are more and more good reasons for using existing care data, with the focus in particular on the use of register data. The associated, clearly structured methodological procedure has so far been insufficiently combined, prepared and presented transparently. The German Network for Health Services Research (DNVF) has therefore set up an ad hoc commission for the use of routine practice data (RWE/RWD). The rapid report prepared by IQWiG on the scientific development of concepts for "generation of care-related data and their evaluation for the purpose of benefit assessment of medicinal products according to § 35a SGB V" is an essential step for the use of register data for the generation of evidence. The "Memorandum Register - Update 2019" published by DNVF 2020 also describes the requirements and methodological foundations of registers. Best practice examples from oncology, which are based on the uniform oncological basic data set for clinical cancer registration (§ 65c SGB V), show, for example, that guidelines can be checked and recommendations for guidelines and necessary interventions can be derived in the sense of knowledge-generating health services research using register data. At the same time, however, there are no clear quality requirements and structured formal and content-related procedures in the areas of data consolidation, data verification and the use of specific methods depending on the question at hand. The previously inconsistent requirements are to be revised and a method guide for the use of suited data is to be developed and published. The first chapter of the manual on methods of care-related data explains the objective and structure of the manual. It explains why the use of the term "routine practice data" is more effective than the use of the terms Real Word Data (RWD) and Real World Evidence (RWE). By avoiding the term "real world" it should be emphasized in particular that high-quality research can also be based on routine practice data (e. g. register-based comparative studies).

Feasibility testing of the Core set of quality Indicators for Paediatric Primary Care in Europe, COSI-PPC-EU.

There is a need to measure and improve the quality of paediatric primary care in Europe where major differences in the delivery and outcomes of child health care exist. A collaborative panel of paediatric senior experts developed a Core Set of Indicators for Paediatric Primary Care in Europe by compiling 42 quality indicators in a modified consensus process following the RAND/UCLA appropriateness method. The aim of this study was to explore the feasibility of the quality indicator set in European paediatric primary care practices. Seventy-nine practices from eight countries participated in a detailed online interview. The practices rated the applicability, relevance, reliability and acceptance of the 42 quality indicator as well as the availability, technical feasibility and effort to retrieve the needed data from their medical records. Most quality indicators were considered applicable, available, reliable, acceptable and relevant for monitoring quality of care in paediatric primary care. Respondents rated feasibility and effort to retrieve the data lowest because of difficulties collecting the data from the medical records.Conclusion: European paediatric primary care practices generally agree with the proposed quality indicator set. They document most of the parameters. However, the collection of specific needed values from available routine patient-data is considered technically difficult and time-consuming. What is Known? • Paediatric primary care systems in Europe show striking differences in their performance. Pre-existing sets of quality indicators are predominantly limited to national populations, specific diseases and hospital care. • A Core Set of 42 quality indicators for paediatric primary care in Europe was developed by European paediatricians using a systematic literature review and a consensus process following a modified RAND/UCLA appropriateness method. What is New? • Paediatric primary care providers in Europe agree with the idea to use COSI-PPC-EU to monitor and improve the quality of care. The set was considered applicable, available, reliable, acceptable, and relevant for quality improvement. • The score for feasibility and effort to retrieve the data was low, because of technical reasons; the electronical or paper-based medical documentation in most cases does not allow convenient access to all necessary data.

Development of a core set of quality indicators for paediatric primary care practices in Europe, COSI-PPC-EU.

Paediatric ambulatory healthcare systems in Europe are, because of historical reasons, diverse and show strikingly different outcomes. All across Europe, the benchmarking of structures, processes and outcomes could reveal opportunities for improving Paediatric Primary Care (PPC). The aim of this study was to develop a set of Quality Indicators (QIs) to assess and monitor PPC in Europe. In a three-step process, we used the available external evidence and European expert consensus in a modified RAND/UCLA Appropriateness Method (RAM) to develop an indicator set. (1) A broad literature and online research of published QI and guidelines yielded an inventory of 1516 QI. (2) A collaborative panel of paediatric senior experts from the European Academy of Paediatrics (EAP) and the European Confederation of Primary Care Paediatricians (ECPCP) from 15 European countries participated in a first consensus process to reduce the initial indicator inventory by eliminating not PPC-focused indicators and duplicates. (3) In a second consensus process, the panel rated the QI regarding validity and feasibility. The final QI set "COSI-PPC-EU" consists of 42 indicators in five categories of PPC: (A) health promotion/prevention/screening (13 QI), (B) acute care (9 QI), (C) chronic care (8 QI), (D) practice management (3 QI) and (E) patient safety (9 QI). CONCLUSION: COSI-PPC-EU represents a consented set of a limited number of valid quality indicators for the application in paediatric primary care in different healthcare systems throughout Europe. What is Known: • Paediatric ambulatory healthcare systems in Europe are diverse and show strikingly different outcomes. • There are known gaps in quality performance measures of paediatric primary care in Europe. Pre-existing sets of quality indicators are predominantly limited to national populations, specific diseases and hospital care. What is New: • A set of 42 quality indicators for primary paediatric care in Europe was developed in a multi-country collaborative effort. The method combined a systematic literature review and a consensus process among European paediatric experts. • The quality indicator set can facilitate quality improvement of PPC. After studying the feasibility, providers can use COSI-PPC-EU to monitor, compare and improve performance of practices, regions and countries.