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Digital transformation of healthcare is the dominating discussion topic for all healthcare stakeholders. Digital transformation encompasses all areas of healthcare and is far more than digital healthcare applications (DiGA), digital care applications (DiPA), telemedicine applications, telematics infrastructure activities, and applications from the fields of eHealth, mHealth, or Telehealth. All existing care processes and structures in the healthcare system are undergoing an inventory in order to transfer analog components of care into a digital context. The digital transformation is not taking place exclusively in economic sectors such as healthcare, but is a process of change throughout society in the collection, use, provision, linking and evaluation of information (=data). For the healthcare sector, it is clear that different technical concepts are used, while digital healthcare takes place in different places and at different times, may include different user (groups) and retains, expands or changes the healthcare context. Established healthcare functions such as diagnostics, therapy, documentation and the management of healthcare services are retained and transferred to a digital context. In addition, new application areas will emerge, such as the overarching access to health data by different actors, real-time-driven monitoring systems of holistic health data, (clinical) decision systems, or the provision of data for health services. Even if the majority of the digital transformation has not yet taken place, it is assumed that these functions and application areas of healthcare will serve to sustainably improve the quality of care and benefit the well-being of all (future) patients. For the transfer of existing processes into a digital context and the establishment of new application areas, there are prerequisites for healthcare institutions and the healthcare system itself.

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INTRODUCTION: Digital transformation includes, among other things, the project planning and implementation of digital applications, technologies, and measures and currently represents the day-to-day business of all organizations and institutions in the healthcare sector. In this article, the current activities of digital transformation in healthcare facilities from the perspective of quality management are presented. METHODS: A Germany-wide survey among 141 members of the Society for Quality Management in Healthcare (physicians in private practice, hospitals, health insurers, and other healthcare institutions) was conducted on all fields of digital technologies, existing projects, and digital technologies that are currently being implemented. Based on six thematic modules, the participants evaluated the chronological sequence and the relevance of the content for their organization. RESULTS: Of the survey participants, 82% stated that digital transformation influences or changes their everyday workplace. The most frequent projects include topics from process and interface management (53%) and improving patient safety (52%). The most frequent concrete projects are electronic patient files and topics that were commissioned as part of the Krankenhauszukunftsgesetz. DISCUSSION: According to the respondents, digital transformation is changing the structures and processes of healthcare facilities and requires additional competencies so that digital technologies can be implemented in a targeted and sustainable manner. A structured coordination of the competencies of all professions in a healthcare facility is required to anchor digital technologies in the everyday life of healthcare facilities.

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BACKGROUND: Recommendations of evidence- and formally consensus-based clinical practice guidelines (CPGs) represent a valuable source of quality indicators (QIs). Nevertheless, a standardized methodological procedure for developing QIs in the context of CPGs does not yet exist in Germany for all CPGs. For this reason, a methodological standard for the guideline-based development of QIs (QI Standard) was developed based on a structured consensus process involving multiple key stakeholders. METHODS: The proposed content of the QI Standard was derived from evidence, drawing upon results of reviews and qualitative studies, and considered German manuals for guideline-based QI development of two guideline programs. A multi-perspective consensus panel, broadly representing key stakeholders from the German healthcare system with expertise in CPGs and/or quality management, was nominated to vote on recommendations for guideline-based development of QIs. The iterative, structured consensus process included a two-stage online survey based on the Delphi method ("preliminary voting") and a moderated final stakeholder conference where all those recommendations were definitely included in the QI Standard that received approval of more than 75 % (consensus criterion) of the consensus panel. RESULTS: Based on the agreed QI Standard, the QI development process starts with a criteria-based selection of "potential" QIs which - in case of adoption - are published in CPGs as "preliminary" QIs and can achieve the status "final" after successful testing. The QI Standard is composed of a total of 30 recommendations, which are allocated to six areas: A) preparatory work steps for the guideline-based recommendation of QIs, B) QI development group and cooperation with the CPG group, C) development of potential QIs, D) critical appraisal of potential QIs, E) formal adoption and publication as well as F) piloting/testing of preliminary QIs and conversion into final QIs. DISCUSSION: Before the QI Standard can be recommended for implementation in future CPGs, it should have been successfully tested in selected German CPG projects. In addition to methodological requirements for the QI development, it must be ensured that guideline groups have adequate resources for the implementation of the QI Standard. CONCLUSION: By using the QI Standard, scientifically sound and healthcare-relevant QIs can be expected.

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BACKGROUND: Close, continuous and efficient collaboration between different professions and sectors of care is necessary to provide patient-centered care for individuals with mental disorders. The lack of structured collaboration between in- and outpatient care constitutes a limitation of the German health care system. Since 2012, a new law in Germany (§64b Social code book (SGB) V) has enabled the establishment of cross-sectoral and patient-centered treatment models in psychiatry. Such model projects follow a capitation budget, i.e. a total per patient budget of inpatient and outpatient care in psychiatric clinics. Providers are able to choose the treatment form and adapt the treatment to the needs of the patients. The present study (EVA64) will investigate the effectiveness, costs and efficiency of almost all model projects established in Germany between 2013 and 2016. METHODS/DESIGN: A health insurance data-based controlled cohort study is used. Data from up to 89 statutory health insurance (SHI) funds, i.e. 79% of all SHI funds in Germany (May 2017), on inpatient and outpatient care, pharmaceutical and non-pharmaceutical treatments and sick leave for a period of 7 years will be analyzed. All patients insured by any of the participating SHI funds and treated in one of the model hospitals for any of 16 pre-defined mental disorders will be compared with patients in routine care. Sick leave (primary outcome), utilization of inpatient care (primary outcome), utilization of outpatient care, continuity of contacts in (psychiatric) care, physician and hospital hopping, re-admission rate, comorbidity, mortality, disease progression, and guideline adherence will be analyzed. Cost and effectivity of model and routine care will be estimated using cost-effectiveness analyses. Up to 10 control hospitals for each of the 18 model hospitals will be selected according to a pre-defined algorithm. DISCUSSION: The evaluation of complex interventions is an important main task of health services research and constitutes the basis of evidence-guided advancement in health care. The study will yield important new evidence to guide the future provision of routine care for mentally ill patients in Germany and possibly beyond. TRIAL REGISTRATION: This study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713 ).

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We conducted a systematic review of clinical guidelines (CGs) to examine the methodological approaches of quality indicator derivation in CGs, the frequency of quality indicators to check CG recommendations in routine care, and clinimetric properties of quality indicators. We analyzed the publicly available CG databases of the Association of the Scientific Medical Societies in Germany (AWMF) and National Institute for Health and Care Excellence (NICE). Data on the methodology of subsequent quality indicator derivation, the content and definition of recommended quality indicators, and clinimetric properties of measurement instruments were extracted. In Germany, no explicit methodological guidance exists, but 3 different approaches are used. For NICE, a general approach is used for the derivation of quality indicators out of quality standards. Quality indicators were defined in 34 out of 87 CGs (39%) in Germany and for 58 out of 133 (43%) NICE CGs. Statements regarding measurement properties of instruments for quality indicator assessment were missing in German and NICE documents. Thirteen pairs of CGs (32%) have associated quality indicators. Thirty-four quality indicators refer to the same aspect of the quality of care, which corresponds to 27% of the German and 7% of NICE quality indicators. The development of a standardized and internationally accepted methodology for the derivation of quality indicators relevant to CGs is needed to measure and compare quality of care in health care systems.

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BACKGROUND: Analysis of the regional development of spine surgery in Germany between 2005 and 2014. MATERIAL AND METHODS: A secondary data analysis of inpatient data from the Scientific Institute of the AOK (WIdO) was carried out for the period 2005 to 2014. The number of spinal procedures was determined on the basis of 14 defined intervention groups (procedures according to OPS codes). The regional numbers of spine surgery procedures in the 402 districts in Germany and the regional age- and gender-standardised distribution are displayed as healthcare utilisation charts. RESULTS: 796,870 AOK-insured individuals received inpatient spinal surgery during the observation period. The relative increase in the 10-year period was 82%, with 51,053 interventions in 2005 and 91,971 interventions in 2014. The increase in spine surgery cases occurred mainly between 2005 and 2011. An increase in the number of operations was observed in all intervention groups except "excision of intervertebral discs and bones". It was different in different spinal procedures, with the greatest increases in "bone decompression" (280% increase). Regional differences were found in all intervention groups. In 2014, the number of interventions varied between 109 and 729 interventions per 100,000 AOK-insured individuals in the districts. CONCLUSION: The significant increases of more than 80% in 10 years cannot be explained solely by sociodemographic changes. The pronounced regional differences alone do not allow firm conclusions on the existence of regional underuse, overuse or misuse. The results, however, emphasise the need for further health services research on the quality of the medical indication and the determinants of regional variation.

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BACKGROUND: Inclusion of patient-reported outcomes (PROs) in routine cancer care is of key importance for individualized treatment, shared decision making and patient satisfaction. OBJECTIVE: To describe the implementation under routine conditions of an electronic self-administered PRO assessment and comparison of PROs before and after inpatient treatment in oncologic care. METHODS: In a tablet-based survey PROs on symptom burden, global health status/ quality of life (QoL) and health utility were collected twice (at hospital admission and discharge) in an inpatient oncological setting over a 17-month period using the EORTC QLQ-C30 and EQ-5D questionnaires. Data were linked to the hospital information system (HIS). Patient acceptability, recruitment rates, symptom burden, and clinically meaningful changes in PROs over time were analyzed. RESULTS: From a total of 384 hospitalized patients invited to participate at admission 371 (96.6 %) participated. At discharge, 195 patients were approached for a follow-up assessment, and 192 patients (98.5 %) participated. Despite strong acceptance among patients, recruitment rates were decreasing over time. During the hospital stay clinically meaningful improvements were observed for health utility (33.3 %, n = 64) and global health status/QoL (43.2 %, n = 83). Patients reported a variety of symptoms at admission and discharge. CONCLUSIONS: Implementation of PRO assessment in routine care and data integration into the HIS provides valuable information for the entire medical staff as symptom burden is present during the entire hospital stay. IMPLICATIONS FOR PRACTICE: Long-term maintenance of PRO assessment in a clinical setting as a prerequisite of value-based healthcare requires continuous involvement of the nursing team, which can only be achieved by allocating resources to this task.

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BACKGROUND: Falls are a relevant issue of inpatient treatment. Epidemiological analysis concerning incidence, risk factors for falls and the quality of risk assessments are missing. METHODS: In a routine data-based cross-sectional study all patients hospitalized in the University Hospital Dresden, Germany, during 2012 and 2013 were analyzed according to fall incidence and risk factors (items of Dresden fall risk assessment [Dresden-FRA], age, sex, severity of disease, and length of stay. Fall risk and associated risk factors were determined using descriptive methods and logistic regression models. In addition, the quality of the fall risk assessment was evaluated. RESULTS: The risk of falling during the observation period was 1.6 %. Differences exist between the medical disciplines (risk of falling 0.1 % to 9.8 %). The fall rate was 2.9/1,000 days of treatment. Higher age, longer inpatient stay, and a higher level of disease severity were significant predictors of falls. Less serious consequences of falls were more frequently documented (84 %) than consequences of falls requiring treatment (16 %). All nine items of the Dresden-FRA were significant risk factors. The sensitivity and specificity of the Dresden-FRA were 69.9 % and 71.4 %, respectively. CONCLUSION: Patients at an older age and with more severe disease have a higher risk of falling. The validated assessment of the individual risk of falling is an important tool of medical quality management and risk management. The present study can help to raise awareness about the quality of risk assessments, to further improve fall risk assessment, and to increase patient safety in acute care.

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PURPOSE: Cancer patients suffer from a variety of symptoms, but little is known about changes during hospitalization and symptom burden at discharge. We implemented an electronic quality of life (QoL) assessment used by the nursing team in routine inpatient care. Feasibility, acceptance, and the course of QoL were investigated. METHODS: A self-administered electronic questionnaire based on the EQ-5D and the EORTC QLQ-C30 was applied in clinical routine. Cancer patients were approached by the nursing staff to complete the QoL assessment twice, at admission and at the day of discharge. Both the feedback of the nursing staff as well as characteristics of participants were used to evaluate the electronic assessment. RESULTS: Out of 210 patients from an oncologic ward, 85 patients (40 %) were invited to participate, 95 % of whom (n = 81) agreed to participate. Participation rate depended on the day of admission, the presence of the coordinating nurse, the overall morbidity assessed by patient clinical complexity level, and the patient age. Forty-six patients (56 %) asked for assistance in completing the questionnaire. Patients older than 53 years and male patients were more likely to need assistance. Twenty-two percent of the nursing staff (n = 5) use the information assessed for individual patient care. Fifty-two percent (n = 12) rated the additional workload as very little or little and 68 % (n = 15) agreed that handling for the patient was easy. Global QoL improved during the stay. Most severe symptoms at admission included fatigue, pain, appetite loss, and insomnia. CONCLUSIONS: The results of this study indicate that it is feasible to implement and use an electronic QoL assessment by the nursing staff in routine inpatient cancer care. Obstacles and worries of staff members have to be considered when further developing this program.

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BACKGROUND: Joint replacement surgery is one of the most often performed routine procedures for the treatment of knee osteoarthritis in Germany. Currently, there is no consensus on indication criteria for total knee arthroplasty (TKA). OBJECTIVES: The topic indication for TKA was processed using six guiding questions concerning: 1) Common practice in determining the indication for TKA; 2) Inclusion criteria in clinical trials; 3) Treatment goals/goal criteria; 4) Predictors for goal attainment; 5) Economic aspects of determining a TKA indication; 6) Guidelines of the "Working Group of Scientific Medical Societies" (AWMF) in other areas. METHODS: The evidence mapping was conducted by systematically searching Medline via Ovid, the Cochrane Library, through hand searching national guidelines and selected journals as well as the AWMF guideline portal. RESULTS OF THE GUIDING QUESTIONS: 1) In Germany there is currently no consented guideline regarding indications for TKA surgery. 2) Indication criteria for clinical trials are: diagnosed osteoarthritis of the knee, limitations of age and BMI. The most common criteria for exclusion include rheumatoid/inflammatory arthritis, secondary diagnoses and allergies. 3) As yet, no international initiatives have been identified which, by involving all relevant stakeholders, have reached consensus regarding the indication criteria for TKA. 4) A variety of predictors were identified with effects on individual treatment goals acting in different directions. 5) Very few studies were identified concerning economic aspects of determining TKA indication. 6) Comparable AWMF guidelines are currently not available. CONCLUSION: The findings of this study suggest that specific systematic reviews are needed to explore the following questions: What are the treatment goals of a TKA intervention? For whom are these relevant? And how are they measured? Continuous analyses are recommended in the field of predictors for a positive TKA outcome.

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OBJECTIVE: Peer review focuses on critical self-reflection, especially of physicians in direct contact and dialogue with other disciplines and professional groups. The main purpose of the peer review is the principle of self-determination, the intention to learn from each other more effectively, and a commitment to quality improvement. During the past five years the Quality in Medicine Initiative (IQM) has successfully promotes peer reviewing in German-speaking areas. The aim of this study is to investigate all records of IQM peer reviews and to outline the results in the course of development. The major focuses include medical aspects for improvement, information concerning organizational processes and the satisfaction of the visited hospitals. METHOD: A systematic descriptive analysis of all records as well as feedback sheets was conducted between 2010 and 2014. RESULTS: 294 of 304 planned peer reviews were considered, involving among different hospital owners and different clinical conditions. The identified potential for improvement of the peer team was higher than that of the physicians of the hospitals visited. The assessment of the medical review criteria illustrates the following different trends: a positive development occurred concerning the appropriate and timely diagnostic and treatment; a clear potential for improvement could be established concerning a complete and conclusive documentation. Regarding the clinical conditions, anomalies were identified which are important for all IQM hospitals. As regards sustainability, first results from so-called re-reviews were available and provided important information pointing in the direction of structure and process improvement. The satisfaction of the visited physicians increased continuously within these five years. CONCLUSION: In the light of all data records and satisfaction sheets, the IQM peer review has become well-established over the last five years. Possible reasons are a well-defined framework, clear structures and different kinds of support. The success of the cooperation of the German Medical Association and IQM is illustrated by the development of the curriculum peer review. Re-reviews provide impulses for sustainability. At any rate, there is a need for scientific evaluation of the peer review method in order to generate evidence for this important tool of quality improvement.

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Process management (PM) is a valuable method for the systematic analysis and structural optimisation of the quality and safety of clinical treatment. PM requires a high motivation and willingness to implement changes of both employees and management. Definition of quality indicators is required to systematically measure the quality of the specified processes. One way to represent comparable quality results is the use of quality indicators of the external quality assurance in accordance with Sect. 137 SGB V­a method which the Federal Joint Committee (GBA) and the institutions commissioned by the GBA have employed and consistently enhanced for more than ten years. Information on the quality of inpatient treatment is available for 30 defined subjects throughout Germany. The combination of specified processes with quality indicators is beneficial for the information of employees. A process-based indicator dashboard provides essential information about the treatment process. These can be used for process analysis. In a continuous consideration of these indicator results values can be determined and errors will be remedied quickly. If due consideration is given to these indicators, they can be used for benchmarking to identify potential process improvements.

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The assessment of the health state in patients and changes in their health state for the purpose of diagnosis, prognosis and monitoring of treatment response plays a central role in clinical practice. Quality criteria for measurements in medicine include validity, reliability, responsiveness, interpretability, and feasibility. High-quality measurement instruments are a prerequisite for evidence-based medicine. Therefore, international outcomes research groups have developed methods for quality assurance and for the standardisation of measurement instruments. Quality indicators are instruments to measure the quality of care. Due to the increasing relevance of quality assessment for all stakeholders in healthcare and due to the political intention to draw relevant conclusions from the assessment of the quality of care, quality indicators must at least meet the same high standards that are required for clinical trial end points. However, independent researchers and clinicians do not engage in the validation and standardisation of quality indicators in Germany; currently, only the AQUA institute (as assigned by the German GBA) deals with this important issue. Current activities concerning the validation of quality indicators do not meet the requirements of evidence-based healthcare. This is a critical barrier to achieving the political goals of quality medicine. Therefore, the authors propose a multi-step, multi-professional, evidence-driven and evidence-generating consensus process on the basis of established methods of outcomes research for the advancement of quality assessment with quality indicators in Germany. All relevant stakeholders should participate in this process.

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BACKGROUND: Obligatory external quality assurance is an established method used to ensure the quality of inpatient care in Germany. The comprehensive approach is unique in international comparison. In addition to the statutory requirement, the health insurance funds require this form of external quality control in order to foster quality-based competition between hospitals. Ever since its introduction, healthcare providers have scrutinised the effects of the mandatory use of this survey. METHOD AND MATERIALS: The study was based on all patients in the University Hospital Dresden, for whom a quality assurance sheet (n = 45,639) had to be recorded between 2003 and 2011. The documentation of these sheets was carried out by specially trained personnel. For each performance area, the duration of the documentation quality sheets was assessed, and a descriptive analysis of all quality assurance sheets was conducted. In the presence of statistical significance the so-called "Structured Dialogues" were analysed. RESULTS: Over the whole period, 167 statistically noticeable problems occurred. Nine of these have been rated as noticeable problems in medical quality by the specialised working groups of the project office quality assurance (PGSQS) at the Saxon State Medical Association (SLÄK). The remaining 158 statistical anomalies included 25 documentation errors; 96 were classified as statistically significant, and only 37 were marked to indicate that re-observation by the PGSQS was required. The total effort estimate for the documentation of quality assurance sheets was approximately 1,420 working days in the observation period. DISCUSSION: As far as the quality of patient care is concerned, the results can be considered positive because only a small number of quality indicators indicate noticeable qualitative problems. This statement is based primarily on the comparison of the groups of Saxony and Germany, which are included in the quality report of external quality assurance in accordance with sect. 137 SGB V. The majority of noticeable statistical problems were due to documentation errors. Other noticeable statistical problems that are medically indicated, but without effect on the extramural care to patients, recurrently occur with the respective quality indicators. Examples include the postoperative mobility indicators of the implementation of endoprostheses which cannot be used to draw conclusions about patient outcomes. Information on the quality of life as well as the post-hospital course of disease would be important in this context, but is still lacking. The use of external quality assurance data in accordance with sect. 137 SGB V for evaluation research has so far been handled quite restrictively. Thus, in-depth analyses on the quality of treatment cannot be derived.

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