[Position Paper of The AG Digital Health DNVF on Digital Health Applications: Framework Conditions For Use in Health Care, Structural Development and Science]. / Digitale Gesundheitsanwendungen ­ Rahmenbedingungen zur Nutzung in Versorgung, Strukturentwicklung und Wissenschaft ­ Positionspapier der AG Digital Health des DNVF.

The term "digital health" is currently the most comprehensive term that includes all information and communication technologies in healthcare, including e-health, mobile health, telemedicine, big data, health apps and others. Digital health can be seen as a good example of the use of the concept and methodology of health services research in the interaction between complex interventions and complex contexts. The position paper deals with 1) digital health as the subject of health services research; 2) digital health as a methodological and ethical challenge for health services research. The often-postulated benefits of digital health interventions should be demonstrated with good studies. First systematic evaluations of apps for "treatment support" show that risks are higher than benefits. The need for a rigorous proof applies even more to big data-assisted interventions that support decision-making in the treatment process with the support of artificial intelligence. Of course, from the point of view of health services research, it is worth participating as much as possible in data access available through digital health and "big data". However, there is the risk that a noncritical application of digital health and big data will lead to a return to a linear understanding of biomedical research, which, at best, accepts complex conditions assuming multivariate models but does not take complex facts into account. It is not just a matter of scientific ethical requirements in health services care research, for instance, better research instead of unnecessary research ("reducing waste"), but it is primarily a matter of anticipating the social consequences (system level) of scientific analysis and evaluation. This is both a challenge and an attractive option for health services research to present itself as a mature and responsible scientific discipline.

[Memorandum III, Part 3: Quality of Care and Patient Safety Research Methods]. / DNVF-Memorandum III "Methoden für die Versorgungsforschung", Teil 3: Methoden der Qualitäts- und Patientensicherheitsforschung.

The German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e.V. (DNVF)] fosters the methodological quality of health services research studies by memoranda and other initiatives. Quality of care and patient safety research (QCPSR) form core areas of health services research. The present memorandum explicates principal QCPSR questions and methods. Based on the issues' particular relevance for health policy, the memorandum exemplifies methods for developing and testing indicators, risk adjustment techniques, methods for collecting patient safety data, tools to analyse patient safety incidents and methods for evaluating often complex and multicomponent QCPS interventions. Furthermore, we point out urgent research topics.

Are administrative data valid when measuring patient safety in hospitals? A comparison of data collection methods using a chart review and administrative data.

OBJECTIVE: To evaluate the validity and reliability of German Diagnosis Related Group administrative data to measure indicators of patient safety in comparison to clinical records. DESIGN: A cross-sectional study was conducted using chart review (CR) as gold standard and screening of associated administrative data based on DRG coding. SETTING: Three German somatic acute care hospitals for adults. PARTICIPANTS: A total of 3000 cases treated between May and December, 2010. MAIN OUTCOME MEASURES: Eight indicators were used to analyse the incidence of associated adverse events (AEs): pressure ulcers, catheter-related infections, respiratory failure, deep vein thromboses, hospital-acquired pneumonia, acute renal failure, acute myocardial infarction and wound infections. We calculated sensitivity, specificity, positive predictive value (PPV) and Cohen's Kappa with 95% confidence intervals. RESULTS: Screening of administrative data identified 171 AEs and 456 were identified by CR. A number of 135 identical events were identified by both methods. Sensitivities for the detection of AEs using administrative data ranged from 6 to 100%. Specificities ranged from 99 to 100%. PPV were 33 to 100% and reliabilities were 12 to 85%. CONCLUSIONS: Indicators based on German administrative data deviate widely from indicators based on clinical data. Therefore, hospitals should be cautious to use indicators based on administrative data for quality assurance. However, some might be useful for case findings and quality improvement. The precision of the evaluated indicators needs further development to detect AEs by the valid use of administrative data.

[Patient safety: a topic of the future, the future of the topic]. / Patientensicherheit : Ein Thema mit Zukunft, die Zukunft des Themas.

Almost 10 years ago, the German Coalition for Patient Safety (Aktionsbündnis Patientensicherheit) was founded as a cooperation covering most institutions of the German health care system. As in other countries facing the issue of patient safety, methods for the analysis of "never events" have been developed, instruments for the identification of the "unknown unknowns" have been established (e.g., CIRS), and the paradigm of individual blame has been replaced by organizational, team and management factors. After these first steps, further developments can only be achieved in so far as patient safety is understood as a system property, which leads to specific implications for the further evolution of the healthccare system. The "patient safety movement" has to participate in this discussion in order to avoid misuse of the patient safety concept as a defensive means, merely confined to overcome the adverse events of payment and structural incentives (e.g., diagnosis related groups in the inpatient sector). Because the dominant requirements for the future healthcare system consist of care for an elderly population with chronic and multiple diseases, the focus has to be shifted away from acute and surgical procedures and diseases, as given in the present quality assurance programs in Germany, to prevention and coordination of chronic care. Efforts to improve drug and medication safety of elderly people can be regarded as perfect examples, but other efforts are still missing. Second, the structural problems as the sector-associated optimization of care should be addressed, because typical safety issues are not limited to single sectors but represent problems of missing integration and suboptimal population care (e.g., MRSA). In the third line, the perspectives of society and institutions on safety (and quality of care) must urgently be enlarged to the perspectives of patients on the one hand and the benefit of treatments (e.g., overuse) on the other hand. All these issues are only to be implemented as far as the general societal attitude supportings further improvement of patient safety and is ready to regard it as a major aim for future developments. Cost arguments alone - costs of suboptimal safety can be estimated to around 1 billion in Germany per year - are considered as insufficient to guarantee further improvements because other issues in the healthcare system show similar magnitudes. As a consequence, ethical implications remain as major arguments for ongoing professional and public discussions.

[Clean hands campaign: no chance for healthcare associated infections]. / Krankenhaushygiene--"AKTION Saubere Hände": Keine Chance den Krankenhausinfektionen!

About 500,000 healthcare associated infections can be observed each year in Germany, about 20-30 %, that means 100,000 to 150,000 cases, are avoidable. Healthcare associated infections lead to increased mortality and prolongation of stay. The average prolongation of stay are 4 days, therefore about 2 Million additional hospital days can be determined. In other words about 6 hospitals with 1000 beds each are only caring for patients with healthcare associated infections. Experts agree that careful hand disinfection is the most important procedure to avoid transmission of pathogens. Studies demonstrate that an increasing compliance to hand disinfection leads to a reduction of healthcare associated infections. The clean hands campaign is a joint effort of the National Reference Centre for Surveillance of Nosocomial Infections, the German Society for Quality Management in Healthcare and the Patient Safety Campaign has the objective to achieve a significant improvement of hand hygiene.

Assessment of Patient and Occupational Safety Culture in Hospitals: Development of a Questionnaire with Comparable Dimensions and Results of a Feasibility Study in a German University Hospital.

(1) Background: Both patient and occupational safety cultures should be considered when promoting safety culture. To our knowledge, there are no studies that capture patient safety culture (PSC) and occupational safety culture (OSC) in hospitals while using a common questionnaire. The aim of this feasibility study in a German university hospital was to develop a questionnaire to assess both issues analogously. In addition to feasibility outcomes, we report results of PSC-OSC comparisons. (2) Methods: To assess PSC, we used the existing Hospital Survey on Patient Safety Culture (HSPSC) questionnaire. Developing new OSC "twin items" for certain parts of the HSPSC was supported by a previous literature review. Additionally, we developed multiple choice questions to examine knowledge and competencies regarding specific PS/OS aspects. (3) Results: Developing and implementing a combined PSC and OSC assessment instrument was feasible. The overall response rate was 33% (407 nurses, 140 physicians). In general, the statistical reliability of almost all scales was sufficient. Positive PSC perceptions (agreement rates 46⁻87%) were found in 16 out of 18 scales. Of the four twin scales, the PSC values were significantly better. Individual PS- and OS-related knowledge and competencies were lower than expected. (4) Conclusion: The comparative investigation of patient and occupational safety in a large hospital is a promising approach and can be recommended for further studies. We used our experiences that are presented here in an ongoing bicentric study on the associations between working conditions, occupational safety culture, patient safety culture, and patient safety outcomes (WorkSafeMed).

[Medical centers--methods, purpose and benefits]. / Medizinische Zentren--Systematik und Nutzen.

The German hospital sector is characterized by a profound deficit in organizational integration. The implementation of centers as one way to improve the situation is complicated by the heterogeneity of the concept and understanding of the term "center". The author proposes to distinguish between functional, divisional and process-oriented centers. In German hospitals where the transition from functional to divisional organization is under way matrix elements can be expected to be introduced into organizational practice. Process-oriented centers like breast centers represent matrix components by simultaneously applying functional and process-oriented perspectives. Matrix components map the complexity of clinical structures, but increase coordination and management load and should be applied only to a limited number of care processes.

[A guide to the critical reflection of health services research studies]. / Studien zur Versorgungsforschung. Eine Hilfe zur kritischen Rezeption.

Proponents of evidence-based medicine have developed a framework for the critical appraisal of clinical studies. Though this framework is generally accepted, a universal standard for health services research is not yet available. While clinical research evaluates the efficacy and effectiveness of medical interventions, the remit of health services research is to investigate the actual delivery of care in a given health care system. Here, we propose six criteria for the critical appraisal of work published in the field of health services research: the research question, the validity of the study design, the indicators used, the data source, the audience being addressed and the interests behind a study should all be considered when discussing health services research studies. Ideally, health services research should be an integral part of research efforts including basic as well as clinical research.

[Health services research: innovation transfer in clinical research]. / Versorgungsforschung: Innovationstransfer in der Klinischen Forschung.

Clinical research in Germany suffers from a structural crisis caused by inappropriate input, suboptimal output and low efficiency. The situation is aggravated by fixed DRG-based payments, fix charges for education and research and reductions in governmental funding. Both healthcare system and clinical research in Germany are characterized by a profound sectorization, followed by resource competition between basic science and patient-oriented research. Basic biomedical research in Germany is widely accepted in the international context, but there is a lack of research on the transfer of basic science to clinical trials and everyday healthcare. According to international examples, the 1999 systematology of the Deutsche Forschungs-Gemeinschaft (DFG), a German research foundation, has to be expanded to the dimension of innovation transfer. Clinical translational research focuses on the transfer of basic science to clinical trials, and outcomes research, also known as health services research, describes the transfer of results from clinical trials (efficacy) to clinical application (effectiveness). Outcomes research is interdisciplinary, multiprofessional and patient-oriented. The so-called effectiveness gap between efficacy and effectiveness is determined by patient-sided, professional, organizational and system factors. Outcomes research provides university-based medical research centers with the opportunity to join other stakeholders of the healthcare system and to integrate the universities' scientific standard with its own further development. It is suggested that this widened perspective plays a key role in settling the crisis of clinical research in Germany.

[Patient safety and risk management]. / Patientensicherheit und Risikomanagement.

Patient safety is the latest issue in the present stage of the German health care system, characterized by costs and quality both resulting in value of care. Patient safety defined as "absence of adverse events" represents an important problem, because 10% of in-house patients experience an adverse event, which in nearly 50% of the cases is due to an error (preventable adverse event). Threats and near misses are errors without a consecutive adverse event, much more common and better to integrate in the concept of risk management, which is based on thorough analysis and prevention of errors in medicine. Chart reviews show adverse events in between 3% and 11% of hospital patients, studies with direct observation result in higher estimates (17.7%). Nosocomial infections occur in 3-5%, adverse drug events in 0.17-6.5%, and adverse medical device events in up to 8% of patients. Medication errors (ordering, dosing, distribution) are present in up to 50% of all drug applications. Adverse drug events are important reasons for hospital admissions (3.2-10.8% of all admitted patients), other consequences of adverse drug events are severe disability and death. Mortality of adverse drug events is estimated between 0.04% and 0.95% of all patients. The introduction of risk management in the German health care system is one option to prevent a malpractice crisis similar to the situation in the US health care system in the 1990s. Errors are not to be considered only individual but also organizational failures. Critical incident report systems (CIRS) can help to increase the knowledge about errors, near misses and adverse events, so that prevention of errors can take place. On the organizational level, it is an issue of leaderchip to convince the members of the organization that prevention of errors has a higher priority than punishing and blaming. The medical and other professions, on the other side, have to change their self-understanding from the zero mistake philosophy to accepting errors as common events. This understanding is a prerequisite that analysis can be performed. The participation of patients should be strengthened, because public disclosure is an important issue, although the scientific evidence for real improvement in health care resulting from public disclosure is still inconclusive.

[The hospital perspective: disease management and integrated health care]. / Die Krankenhaus-Perspektive: Disease Management und sektorale Schnittstellen.

Disease Management is a transsectoral, population-based form of health care, which addresses groups of patients with particular clinical entities and risk factors. It refers both to an evidence-based knowledge base and corresponding guidelines, evaluates outcome as a continuous quality improvement process and usually includes active participation of patients. In Germany, the implementation of disease management is associated with financial transactions for risk adjustment between health care assurances [para. 137 f, Book V of Social Code (SGB V)] and represents the second kind of transsectoral care, besides a program designed as integrated health care according to para. 140 a ff f of Book V of Social Code. While in the USA and other countries disease management programs are made available by several institutions involved in health care, in Germany these programs are offered by health care insurers. Assessment of disease management from the hospital perspective will have to consider three questions: How large is the risk to compensate inadequate quality in outpatient care? Are there synergies in internal organisational development? Can the risk of inadequate funding of the global "integrated" budget be tolerated? Transsectoral quality assurance by valid performance indicators and implementation of a quality improvement process are essential. Internal organisational changes can be supported, particularly in the case of DRG introduction. The economic risk and financial output depends on the kind of disease being focussed by the disease management program. In assessing the underlying scientific evidence of their cost effectiveness, societal costs will have to be precisely differentiated from hospital-associated costs.

[Risk Management: concepts and chances for public health]. / Risk Management: Konzepte und Chancen für das Gesundheitswesen.

BACKGROUND: Errors are a common problem in medicine and occur as a result of a complex process involving many contributing factors. Medical errors significantly reduce the safety margin for the patient and contribute additional costs in health care delivery. SYSTEM APPROACH: In most cases adverse events cannot be attributed to a single underlying cause. Therefore an effective risk management strategy must follow a system approach, which is based on counting and analysis of near misses. The development of defenses against the undesired effects of errors should be the main focus rather than asking the question "Who blundered?". Analysis of near misses (which in this context can be compared to indicators) offers several methodological advantages as compared to the analysis of errors and adverse events. Risk management is an integral element of quality management.

[Transferability of patient safety indicators to the German hospital setting: results of a Delphi survey]. / Übertragbarkeit krankenhausbezogener Patientensicherheitsindikatoren für Deutschland: Ergebnis einer Delphi-Befragung.

AIM: To assess the transferability of 14 evidence-based patient safety indicators (PSI) to the German hospital system. METHODS: A two-staged modified multidisciplinary Delphi process was used, applying the scientific criteria of the QUALIFY instrument. RESULTS: Eleven of the 14 PSI were judged to be transferable to and feasible in the German hospital setting. CONCLUSIONS: The consented PSI are potentially suitable for German quality assurance measurement. Prior to implementation, further operationalisation and empirical validation is recommended.

Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors.

OBJECTIVES: To perform a systematic review of the frequency of (preventable) adverse events (AE/PAE) and to analyse contributing factors, such as sample size, settings, type of events, terminology, methods of collecting data and characteristics of study populations. REVIEW METHODS: Search of Medline and Embase from 1995 to 2007. Included were original papers with data on the frequency of AE or PAE, explicit definition of study population and information about methods of assessment. Results were included with percentages of patients having one or more AE/PAE. Extracted data enclosed contributing factors. Data were abstracted and analysed by two researchers independently. RESULTS: 156 studies in 152 publications met our inclusion criteria. 144/156 studies reported AE, 55 PAE (43 both). Sample sizes ranged from 60 to 8,493,876 patients (median: 1361 patients). The reported results for AE varied from 0.1% to 65.4%, and for PAE from 0.1% to 33.9%. Variation clearly decreased with increasing sample size. Estimates did not differ according to setting, type of event or terminology. In studies with fewer than 1000 patients, chart review prevailed, whereas surveys with more than 100,000 patients were based mainly on administrative data. No effect of patient characteristics was found. CONCLUSIONS: The funnel-shaped distribution of AE and PAE rates with sample size is a probable consequence of variation and can be taken as an indirect indicator of study validity. A contributing factor may be the method of data assessment. Further research is needed to explain the results when analysing data by types of event or terminology.

[Leadership in the hospital]. / Führung im Krankenhaus.

Current concepts in leadership and governance on the level of supervisory board, management and departments are often considered as insufficient to cope with the profound structural change which actually takes place in the German health care system. While vertical and horizontal disconnecting is typical of the professional bureaucracy of hospitals, transition from functional to divisional structure further increases this risk. Accordingly, medical experts are oriented towards their professional peers and patient care on the one side; on the other side the management gets isolated and looses operative and strategic control. Several studies provide evidence for the relevance of role models to serve as agents of change, which are now developed into the concept of "Clinical Governance": evidence-based medicine, guidelines, continuous quality improvement, safety culture, resource accountability and organisational learning. The present situation makes it necessary to extend this conception, which focuses on the departmental level in an organisation with divisional features, to one of "Clinical Corporate Governance". This term, which also includes supervisory structures and the management board and is relevant for the total hospital and company, respectively, is based on the corporate governance concept. Inside the hospital, the management and the heads of the departments have to agree that (1) experts really need to be integrated into the decision process, and that (2) the outcomes of the entire hospital have to be regarded as equal or superior to the aims of a single department. The public image of the hospital should be one of a strong and reliable partner in health care and health care business on a local, regional and national level. Members of the supervisory board should clearly put corporate aspects above political and other implications and pay attention to personal independence from the leaders of the medical departments.