ATME-Needs, requirements and cross-sectoral patient journeys of patients with out-of-hospital mechanical ventilation and intensive care in outpatient settings: study protocol for an observational study.

INTRODUCTION: An increasing number of tracheotomised and/or ventilated patients with high-cost out-of-hospital intensive care needs and, at the same time, a decreasing number of healthcare professionals inevitably lead to challenges in the care of this patient population. In addition, little is known about this population, their health restrictions, needs, patient journeys, care structures and processes. The project 'Needs, requirements and cross-sectoral care pathways of out-of-hospital ventilated intensive care patients' (ATME) aims to analyse these aspects and explore current care structures to inform further development of care in line with patients' needs and requirements. METHODS AND ANALYSIS: Qualitative and quantitative methods will be used. In preparation of a semistandardised survey, exploratory interviews will be conducted with tracheotomised and/or ventilated patients with out-of-hospital intensive care needs (TVPOI) (n=15), nursing care providers (n=30), outpatient medical centres, as well as outpatient medical, medical technology and therapeutic care providers (n=35). Three semistandardised survey questionnaires for TVPOI (n=2,000) will be developed and conducted with nursing care facilities (n=250) and outpatient medical centres for mechanical ventilation (n=25). Content analyses will be conducted for qualitative data; survey data will be analysed descriptively. In addition, healthcare claims data will be analysed descriptively to provide information on patient journeys. Three result workshops and one consensus conference will be carried out with representatives of the relevant target groups to analyse the suitability of care structures and to develop recommendations for action to improve TVPOI. ETHICS AND DISSEMINATION: The ATME study received a positive vote from the Ethics Committee of the Osnabrück University of Applied Sciences and is registered in 'Deutsches Register Klinischer Studien (DRKS)' (registration number: DRKS00030891). The study results will be presented at national conferences and in relevant peer-reviewed journals. Additionally, study results will be published by the funding institution (the Innovation Committee of the Federal Joint Committee) on their website.

[What is a public health intervention? Results of a Delphi process in German-speaking countries]. / Was wird unter einer Public-Health-Intervention verstanden? Ergebnisse eines Delphi-Prozesses im deutschsprachigen Raum.

BACKGROUND: Internationally, a variety of definitions for public health interventions (PHI) exist. In the German-speaking countries, however, a definition is still outstanding. Therefore, the aim of this study was to derive consensus criteria for the definition of PHI from the expert perspective of science and practice. METHODS: A Delphi survey with two online rounds was conducted from December 2022 to February 2023. Six criteria were formulated by a working group and posed for consensus: 1) the intention of the intervention, 2) potential conflicts of interest of the initiators of the intervention, 3) primary vs. secondary/tertiary prevention, 4) costs, 5) targeting, and 6) the reach of the intervention. In both Delphi rounds, experts from academia and practice were recruited through relevant networks and associations throughout the German-speaking world. The judgments were asked about standardized rating scales with the possibility of open justification. RESULTS: In the first Delphi round, n = 52 and in the second round n = 43 experts from research, care and administration/management in health care participated. Consensus was reached on four of the six criteria after the second Delphi round: the intention of the intervention, possible conflicts of interest of the initiators of the intervention, primary vs. secondary/tertiary prevention, and the scope of the intervention. From the perspective of the experts interviewed, these are the criteria that distinguish PHI. DISCUSSION AND CONCLUSION: Based on the consensus criteria, PHI can be defined more concretely. Thus, the results contribute to a better inter- and transdisciplinary understanding. Ideally, the criteria will make it easier to assign interventions to the public health sector in the future, even if a precise examination will be necessary in individual cases, among other things because the experts disagreed on the criteria of costs and how to address the target group.

Compliance and patient satisfaction with treatment settings recommended by the medical on-call service 116117 in Germany using computer-assisted structured initial assessment: a cross-sectional observational study accompanying the demand intervention.

OBJECTIVES: In order to reduce the use of emergency departments, computer-assisted initial assessment was implemented at the medical on-call service 116117. Our study assessed compliance and patient satisfaction. DESIGN: Cross-sectional observational postal survey. SETTING: Medical on-call service 116117 by eight Associations of Statutory Health Insurance Physicians in Germany. PARTICIPANTS: The intervention was observed between January 2020 and March 2021. Minors and patients with invalid contact data were excluded. A random sample of eligible patients received standardised questionnaires by mail. OUTCOME MEASURES: We analysed associations of sociodemographic data, health status, previous service use, health literacy, and recommended settings with compliance and patient satisfaction by multivariable, multilevel logistic regression. INTERVENTIONS: Based on symptoms and context factors, the computer software suggested service levels. Staff and patient discussed if higher levels were indicated, services were available and self-transport was possible. They then agreed on recommendations for treatment settings. RESULTS: Of 9473 contacted eligible patients, 1756 patients (18.5%) participated. Median age was 66 years (IQR=50-79), and 986 (59.0%) were women. At least one recommended setting was used by 1397 patients (85.4%). General practitioner (GP) practices were used by 143 patients (68.4%). Generally, better compliance was associated with lower depression levels (OR 1.59, 95% CI 1.17 to 2.17, p=0.003), fewer previous hospital stays (OR 2.02, 95% CI 1.27 to 3.23, p=0.003) and recommendations for any setting other than GP practices (OR 0.13, 95% CI 0.06 to 0.29, p<0001, to OR 0.37, 95% CI 0.19 to 0.72, p=0.003). A total of 606 patients (50.7%) were completely satisfied. Patient satisfaction was associated with higher age (OR 1.30, 95% CI 1.13 to 1.49, p<0.001), better self-rated health (OR 1.30, 95% CI 1.10 to 1.53, p=0.002), not having musculoskeletal disorders (OR 0.68, 95% CI 0.49 to 0.94, p=0.021), better health literacy (OR 0.69, 95% CI 0.54 to 0.89, p=0.005, and OR 0.49, 95% CI 0.36 to 0.67, p<0.001) and receiving no recommendation for GP practices (OR 0.61, 95% CI 0.43 to 0.87, p=0.006). CONCLUSIONS: Most patients were compliant and satisfied. Lowest compliance and satisfaction were found in GP practices, but nonetheless, two of three patients with respective recommendations were willing to use this setting. TRIAL REGISTRATION NUMBER: German Clinical Trials Register DRKS00017014.

[Methodological Standard for the Development of Quality Indicators within Clinical Practice Guidelines - Results of a structured consensus process]. / Methodischer Standard für die Entwicklung von Qualitätsindikatoren im Rahmen von S3-Leitlinien ­ Ergebnisse einer strukturierten Konsensfindung.

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.

Health Technology Assessment of Public Health Interventions Published 2012 to 2016: An Analysis of Characteristics and Comparison of Methods.

OBJECTIVES: The aim of this study was to provide an overview of the methodological characteristics and compare the assessment methods applied in health technology assessments (HTAs) of public health interventions (PHIs). METHODS: We defined a PHI as a population-based intervention on health promotion or for primary prevention of chronic or nonchronic diseases. HTAs on PHIs were identified by systematically searching the Web pages of members of international HTA networks. We included only full HTA reports published between 2012 and 2016. Two reviewers extracted data on the methods used to assess effectiveness/safety, as well as on economic, social, cultural, ethical, and legal aspects using a-priori standardized tables. RESULTS: We included ten HTAs provided by four different organizations. Of these, all reports assessed the effectiveness of the interventions and conducted economic evaluations, seven investigated social/cultural aspects, and four each considered legal and ethical aspects, respectively. Some reports addressed applicability, context/setting, and intervention fidelity issues in different ways. We found that most HTAs adapted their methods to some extent, for example, by including nonrandomized studies, expanding the search strategy, involving stakeholders, or applying a framework to guide the HTA process. CONCLUSIONS: Our analysis provides a comprehensive overview of methods applied in HTAs on public health interventions. We found that a heterogeneous set of approaches is used to deal with the challenges of evaluating complex public health interventions.

Health technology assessment of public health interventions: an analysis of characteristics and comparison of methods-study protocol.

BACKGROUND: Conducting a health technology assessment (HTA) of public health interventions (PHIs) poses some challenges. PHIs are often complex interventions, which affect the number and degree of interactions of the aspects to be assessed. Randomized controlled trials on PHIs are rare as they are difficult to conduct because of ethical or feasibility issues. The aim of this study is to provide an overview of the methodological characteristics and to compare the applied assessment methods in HTAs on PHIs. METHODS: We will systematically search HTA agencies for HTAs on PHIs published between 2012 and 2016. We will identify the HTAs by screening the webpages of members of international HTA organizations. One reviewer will screen the list of HTAs on the webpages of members of international HTA organization, and a second review will double-check the excluded records. For this methodological review, we define a PHI as a population-based intervention on health promotion or for primary prevention of chronic or non-chronic diseases. Only full HTA reports will be included. At maximum, we will include a sample of 100 HTAs. In the case that we identify more than 100 relevant HTAs, we will perform a random selection. We will extract data on effectiveness, safety and economic as well as on social, cultural, ethical and legal aspects in a priori piloted standardized tables. We will not assess the risk of bias as we focus on exploring methodological features. Data extraction will be performed by one reviewer and verified by a second. We will synthesize data using tables and in a structured narrative way. DISCUSSION: Our analysis will provide a comprehensive and current overview of methods applied in HTAs on PHIs. We will discuss approaches that may be promising to overcome the challenges of evaluating PHIs.

Development of indicators for a nationwide cross-sectoral quality assurance procedure for mental health care of patients with schizophrenia, schizotypal and delusional disorders in Germany.

PURPOSE: This paper describes the development of quality indicators for an external statutory and cross-sectoral quality assurance (QA) procedure in the context of the German health care system for adult patients suffering from schizophrenia, schizotypal and delusional disorders (F20-F29). METHODS: Indicators were developed by a modified RAND/UCLA Appropriateness Method with 1) the compilation of an indicator register based on a systematic literature search and analyses of health care claims data, 2) the selection of indicators by an expert panel that rated them for relevance and for feasibility regarding implementation. Indicators rated positive for both relevance and feasibility formed the final indicator set. RESULTS: 847 indicators were identified by different searches. Out of these, 56 were selected for the indicator register. During the formal consensus process the expert panel recommended another 45 indicators so that a total of 101 indicators needed to be considered by the panel. Of these, 27 indicators rated both relevant and feasible were included in the final set of indicators: this set included 4 indicators addressing structures, 19 indicators addressing processes and 4 indicators addressing outcomes. 17 indicators of the set will be reported by hospitals and 8 by psychiatric outpatient facilities. Two indicators considered to be cross-sectoral will be reported by both sectors. DISCUSSION: F20-F29 and its treatment show some specific features which so far have not been addressed by any procedure within the statutory QA program of the German health care system. These features include: Schizophrenia and related disorders a) are potentially chronic conditions, b) are mainly treated in outpatient settings, c) require a multi-professional treatment approach and d) are treated regionally in catchment areas. These specific features in combination with the peculiarities of some legal, political and organizational characteristics of the German health care system and its statutory QA program have strongly influenced the development of indicators. The result was a seemingly "imbalanced" set of indicators with a greater number of indicators for inpatient than for outpatient care despite the fact that clinical reality is otherwise. CONCLUSIONS: The circumstances of the German health care system that restricted the development of this cross-sectoral QA procedure addressing care for F20-F29 are also most likely to emerge with the development of cross-sectoral QA procedures for other (potentially) chronic conditions that are mainly treated in the outpatient setting by multi-professional teams or by networks of different providers. In order to be able to develop a QA procedure that mirrors the reality of service provision for (potentially) chronic diseases such as F20-F29 we need to explore further current and new data sources, diminish sectoral borders, and implement health care responsibility on the level of catchment areas.

Quality indicators for the use of systemic antibiotics in dentistry.

BACKGROUND: Risks resulted from using systemic antibiotics such as increasing rates of bacterial resistance, allergy and side effects should be always weighed individually for each patient against any potential benefits. Routine antibiotic prescribing must be therefore discouraged. The Federal Joint Committee ("Gemeinsamer Bundesauschuss", G-BA) commissioned the AQUA-Institute with the development of an external quality assurance procedure, examining systemic antibiotic use in periodontal, conservative and surgical treatments in ambulatory dental health care. The aim of the procedure was to increase patient safety through rational use of systemic antibiotics and increasing the use of first line medications. MATERIAL AND METHODS: The process of developing the quality indicators included searching for relevant literature and quality indicators, analyzing dental claims data (2013) and antibiotic prescriptions, and finally evaluating the proposed quality indicators in an expert panel. The analysis examined patients who received dental treatments and a prescription for systemic antibiotics. The indicator set consisted of three indicators: usage of systemic antibiotics in dental treatments without indication for antibiotics, the percentage of penicillin prescriptions in dental treatments and the percentage of clindamycin prescriptions in dental treatments. RESULTS: The analysis showed that about 574 million claims on conservative and surgical treatments were made for about 60 million patients. In total, about 4.7 million systemic antibiotics prescriptions were issued for 3.5 million patients with dental treatments. The percentage of patients given a systemic antibiotic as an adjunct to dental treatments, usually without indication, was 3.4 %. The percentage of penicillin prescriptions (as a whole therapeutic/pharmacological subgroup) of the total systemic antibiotic use in dental treatments was 46.3 %; for clindamycin it was 47.0 %. CONCLUSION: Clindamycin is preferred by German dentists, and its overprescription represents an inappropriate use of antibiotics. Optimizing antibiotics prescriptions in dental care through rational use decreases bacterial resistance, increases patient safety and the overall quality of dental care. Future analysis and reporting of the indicators will draw a clear picture of dental antibiotic use, i.e. using a risk adjustment for the first indicator and the implementation of a consistent identification system for dentists in the statutory health insurance (SHI). This will enable a direct connection between dentists and their respective antibiotic prescriptions (causal relationship) and thus highlight areas of need for quality improvement. As such targeted educational activities can be developed on an individual basis.

[Topic identification for cross-sectoral quality assurance in stroke and TIA treatment]. / Themenerschließung für die sektorenübergreifende Qualitätssicherung der Versorgung bei Schlaganfall und TIA.

The development of cross-sectoral quality assurance programs usually requires extensive topic identification. Illustrated by the complex processes of care for stroke and transient ischemic attacks (TIAs), a method for comprehensive topic identification is presented. The first step involves a thorough literature search in terms of systematic reviews, health technology assessments, guidelines, studies into healthcare delivery and the use of specific instruments. Routine data as well as epidemiologic studies are used to analyze the reality of service provision. In addition, experts are consulted to gain expertise concerning deficits of care, approaches to quality assurance and experience with existing quality assurance programs. Furthermore individual patient experiences are collected to add the patients' perceptions of care. Because of the limitation on the regulatory scope of Book V of the German Social Code, which, in this case, was necessary, another source of information was the legal framework and its impact on rescue chain, acute treatment and rehabilitation. Existent quality management systems, accreditations and quality assurance programs in prevention, acute treatment and rehabilitation have been searched in order to avoid any overlap with existing measures. After identifying a total of 71 quality targets according to deficits of care, recommendations for care and expert opinions in primary and secondary prevention, rescue chain, acute treatment, rehabilitation and supply of assistive equipment and therapies, respectively, the usability of instruments was tested. These instruments included case documentation, patient surveys and routine data. 14 quality targets proved to be reproducible by these instruments and were included in the recommendations for a cross-sectoral quality assurance program for stroke and TIA.

Developing cross-sectoral quality assurance for cataract surgery in the statutory quality assurance program of the German health care system: Experiences and lessons learned.

Since 2001, statutory external quality assurance (QA) for hospital care has been in place in the German health system. In 2009, the decision was taken to expand it to cross-sectoral procedures. This novel and unprecedented form of national QA aims at (1) making the quality procedures comparable that are provided both in inpatient and outpatient care, (2) following-up outcomes of hospital care after patients' discharge and (3) measuring the quality of complex treatment chains across interfaces. As a pioneer procedure a QA procedure in cataract surgery QA was developed. Using this as an example, challenges of cross-sectoral QA are highlighted. These challenges relate, in particular, to three technical problems: triggering cases for documentation, following-up patients' after hospital discharge, and the burden of documentation in outpatient care. These problems resulted finally in the haltering of the development of the QA procedure. However, the experiences gained with this first development of cross-sectoral QA inspired the reorientation and further development of the field in Germany. Future cross-sectoral QA will rigorously aim at keeping burden of documentation small. It will draw data for QA mainly at three sources: routine data, patient surveys and peer reviews using indicators. Policy implications of this reorientation are discussed.

[Quality measurement using administrative data in mandatory quality assurance]. / Qualitätsmessung mit Routinedaten in der gesetzlichen Qualitätssicherung am Beispiel Dekubitusprophylaxe.

For several years, the use of administrative data in mandatory quality measurement has been requested by several stakeholders in Germany. Main advantages of using administrative data include the reduction of documentary expenditures and the possibility to perform longitudinal quality analyses across different healthcare units. After a short introduction, a brief overview of the current use of administrative data for mandatory quality assurance as well as current developments is given, which will then be further exemplified by decubital ulcer prophylaxis. By using administrative data coding expenditures in this clinical area could be reduced by nine million data fields. At the same time the population analysed was expanded resulting in a more than tenfold increase in potentially quality-relevant events. Finally, perspectives, further developments, possibilities as well as limits of quality measurement with administrative data are discussed.

[Current challenges of external quality assurance in the German healthcare system]. / Aktuelle Herausforderungen der externen Qualitätssicherung im deutschen Gesundheitswesen.

External quality assurance has three main aims: to make service provision in medicine and nursing comparable, to systematically identify deficits in service quality and to support the introduction of measures for quality improvement. This article reflects on three major developments in mandatory external quality assurance in the German healthcare system that took place during the last five years. These developments include the implementation of cross-sectoral quality assurance, the utilisation of new data sources and a new focus on quality deficits and practicability. The article highlights the challenges that come along with these developments.