Health economic evaluation of blended collaborative care for older multimorbid heart failure patients: study protocol.

BACKGROUND: Integrated care, in particular the 'Blended Collaborative Care (BCC)' strategy, may have the potential to improve health-related quality of life (HRQoL) in multimorbid patients with heart failure (HF) and psychosocial burden at no or low additional cost. The ESCAPE trial is a randomised controlled trial for the evaluation of a BCC approach in five European countries. For the economic evaluation of alongside this trial, the four main objectives were: (i) to document the costs of delivering the intervention, (ii) to assess the running costs across study sites, (iii) to evaluate short-term cost-effectiveness and cost-utility compared to providers' usual care, and (iv) to examine the budgetary implications. METHODS: The trial-based economic analyses will include cross-country cost-effectiveness and cost-utility assessments from a payer perspective. The cost-utility analysis will calculate quality-adjusted life years (QALYs) using the EQ-5D-5L and national value sets. Cost-effectiveness will include the cost per hospital admission avoided and the cost per depression-free days (DFD). Resource use will be measured from different sources, including electronic medical health records, standardised questionnaires, patient receipts and a care manager survey. Uncertainty will be addressed using bootstrapping. DISCUSSION: The various methods and approaches used for data acquisition should provide insights into the potential benefits and cost-effectiveness of a BCC intervention. Providing the economic evaluation of ESCAPE will contribute to a country-based structural and organisational planning of BCC (e.g., the number of patients that may benefit, how many care managers are needed). Improved care is expected to enhance health-related quality of life at little or no extra cost. TRIAL REGISTRATION: The study follows CHEERS2022 and is registered at the German Clinical Trials Register (DRKS00025120).

Developing quality indicators for cross-sectoral psycho-oncology in Germany: combining the RAND/UCLA appropriateness method with a Delphi technique.

BACKGROUND: Internationally, the need for appropriately structured, high-quality care in psycho-oncology is more and more recognized and quality-oriented care is to be established. Quality indicators are becoming increasingly important for a systematic development and improvement of the quality of care. The aim of this study was to develop a set of quality indicators for a new form of care, a cross-sectoral psycho-oncological care program in the German health care system. METHODS: The widely established RAND/UCLA Appropriateness Method was combined with a modified Delphi technique. A systematic literature review was conducted to identify existing indicators. All identified indicators were evaluated and rated in a two-round Delphi process. Expert panels embedded in the Delphi process assessed the indicators in terms of relevance, data availability and feasibility. An indicator was accepted by consensus if at least 75% of the ratings corresponded to category 4 or 5 on a five-point Likert scale. RESULTS: Of the 88 potential indicators derived from a systematic literature review and other sources, 29 were deemed relevant in the first Delphi round. After the first expert panel, 28 of the dissented indicators were re-rated and added. Of these 57 indicators, 45 were found to be feasible in terms of data availability by the second round of expert panel. In total, 22 indicators were transferred into a quality report, implemented and tested within the care networks for participatory quality improvement. In the second Delphi round, the embedded indicators were tested for their practicability. The final set includes 16 indicators that were operationalized in care practice and rated by the expert panel as relevant, comprehensible, and suitable for care practice. CONCLUSION: The developed set of quality indicators has proven in practical testing to be a valid quality assurance tool for internal and external quality management. The study findings could contribute to traceable high quality in cross-sectoral psycho-oncology by providing a valid and comprehensive set of quality indicators. TRIAL REGISTRATION: "Entwicklung eines Qualitätsmanagementsystems in der integrierten, sektorenübergreifenden Psychoonkologie-AP "Qualitätsmanagement und Versorgungsmanagement" zur Studie "integrierte, sektorenübergreifende Psychoonkologie (isPO)" a sub-project of the "integrierte, sektorenübergreifende Psychoonkologie (isPO)", was registered in the German Clinical Trials Register (DRKS) (DRKS-ID: DRKS00021515) on 3rd September 2020. The main project was registered on 30th October 2018 (DRKS-ID: DRKS00015326).

Factors influencing adherence to clinical practice guidelines in patients with suspected chronic coronary syndrome: a qualitative interview study in the ambulatory care sector in Germany.

BACKGROUND: Chronic coronary syndrome (CCS) is a potentially progressive clinical presentation of coronary artery disease (CAD). Clinical practice guidelines (CPGs) are available for prevention, diagnosis, and treatment. Embedded in the "ENLIGHT-KHK" healthcare project, a qualitative study was conducted to identify factors that influence guideline adherence from the perspective of general practitioners (GPs) and cardiologists (CA) in the ambulatory care sector in Germany. METHODS: GPs and CAs were surveyed via telephone using an interview guide. The respondents were first asked about their individual approach to caring for patients with suspected CCS. Subsequently, the accordance of their approach with guideline recommendations was addressed. Finally, potential measures for assisting with guideline adherence were discussed. The semi-structured interviews were transcribed verbatim and analysed using a qualitative content analysis in accordance with Kuckartz and Rädiker. Factors influencing adherence to CPGs were categorised by assessing whether they (i) inhibited or facilitated guideline adherence, (ii) played a role in patients at risk of CCS or with suspected or known CCS, (iii) were mentioned in implicit or explicit thematic reference to CPGs, and (iv) were declared a practical problem. RESULTS: Based on interviews with ten GPs and five CAs, 35 potential influencing factors were identified. These emerged at four levels: patients, healthcare providers, CPGs, and the healthcare system. The most commonly cited barrier to guideline adherence among the respondents was structural aspects at the system level, including reachability of providers and services, waiting times, reimbursement through statutory health insurance (SHI) providers, and contract offers. There was a strong emphasis on interdependencies between factors acting at different levels. For instance, poor reachability of providers and services at the system level may result in inexpedience of guideline recommendations at the CPG level. Likewise, poor reachability of providers and services at the system level may be aggravated or alleviated by factors such as diagnostic preferences at the patient level or collaborations at the provider level. CONCLUSIONS: To assist with adherence to CPGs regarding CCS, promoting measures may be needed that account for interdependencies between barriers and facilitators at various healthcare levels. Respective measures should consider medically justified deviations from guideline recommendations in individual cases. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00015638; Universal Trial Number (UTN): U1111-1227-8055.

Patient Portals as Facilitators of Engagement in Patients With Diabetes and Chronic Heart Disease: Scoping Review of Usage and Usability.

BACKGROUND: Patient portals have the potential to improve care for chronically ill patients by engaging them in their treatment. These platforms can work, for example, as a standalone self-management intervention or a tethered link to treatment providers in routine care. Many different types of portals are available for different patient groups, providing various features. OBJECTIVE: This scoping review aims to summarize the current literature on patient portals for patients with diabetes mellitus and chronic heart disease regarding usage behavior and usability. METHODS: We conducted this review according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement for scoping reviews. We performed database searches using PubMed, PsycInfo, and CINAHL, as well as additional searches in reviews and reference lists. We restricted our search to 2010. Qualitative and quantitative studies, and studies using both approaches that analyzed usage behavior or usability of patient portals were eligible. We mapped portal features according to broad thematic categories and summarized the results of the included studies separately according to outcome and research design. RESULTS: After screening, we finally included 85 studies. Most studies were about patients with diabetes, included patients younger than 65 years, and were conducted in the United States. Portal features were categorized into educational/general information, reminder, monitoring, interactivity, personal health information, electronic/personal health record, and communication. Portals mostly provided educational, monitoring, and communication-related features. Studies reported on usage behavior including associated variables, usability dimensions, and suggestions for improvement. Various ways of reporting usage frequency were identified. A noticeable decline in portal usage over time was reported frequently. Age was most frequently studied in association with portal use, followed by gender, education, and eHealth literacy. Younger age and higher education were often associated with higher portal use. In two-thirds of studies reporting on portal usability, the portals were rated as user friendly and comprehensible, although measurement and reporting were heterogeneous. Portals were considered helpful for self-management through positive influences on motivation, health awareness, and behavioral changes. Helpful features for self-management were educational/general information and monitoring. Barriers to portal use were general (eg, aspects of design or general usability), related to specific situations during portal use (eg, login procedure), or not portal specific (eg, user skills and preferences). Frequent themes were aspects of design, usability, and technology. Suggestions for improvement were mainly related to technical issues and need for support. CONCLUSIONS: The current state of research emphasizes the importance of involving patients in the development and evaluation of patient portals. The consideration of various research designs in a scoping review is helpful for a deeper understanding of usage behavior and usability. Future research should focus on the role of disease burden, and usage behavior and usability among older patients.

Effectiveness of evidence-based decision aids for women with pathogenic BRCA1 or BRCA2 variants in the german health care context: results from a randomized controlled trial.

BACKGROUND: Women with pathogenic BRCA1 or BRCA2 variants are at high risk for breast and ovarian cancer. Preventive options include risk-reducing breast and ovarian surgeries and intensified breast surveillance. However, individual decision-making is often associated with decisional conflicts. Two evidence-based decision aids have recently been developed for these women (healthy or with unilateral breast cancer) for the German context to support them in their decision-making process. This study evaluated their effectiveness. METHODS: In a randomized controlled study, women (aged 18-70 years) with pathogenic BRCA1 or BRCA2 variants were randomly assigned 1:1 to the intervention (IG, n = 230) or control (CG, n = 220) group. All participants received usual care. After baseline survey (t0), IG participants additionally received the DAs. Follow-up surveys were at three (t1) and six (t2) months. Primary outcome was decisional conflict at t1. Secondary analyses included decision status, decision regret, knowledge on risks and preventive options, self-reported psychological symptoms, acceptability of DAs, and preparation for decision-making. RESULTS: Of 450 women recruited, 417 completed t0, 398 completed t1 and 386 completed t2. Compared to CG, IG participants had lower decisional conflict scores at t1 (p = 0.049) and t2 (p = 0.006) and higher scores for knowledge (p = 0.004), acceptability (p = 0.000), and preparation for decision-making (p < 0.01). CONCLUSIONS: These DAs can help improve key parameters of decision-making in women with pathogenic BRCA1 and BRCA2 variants and, thus, provide a useful add-on to the current counseling and care concept for these women in Germany. TRIAL REGISTRATION: German Clinical Trials Register, DRKS-ID: DRKS00015823, retrospectively registered 14/06/2019.

[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.

Characteristics of desirable ambulatory health and oral healthcare from the perspective of community-dwelling people aged 80 and over-a qualitative examination.

BACKGROUND: people aged 80 and over frequently have diverse and complex health trajectories, which has been well studied. But their oral health is seldom included in care models. To realise comprehensive healthcare, both general and oral ambulatory (i.e. outpatient) healthcare need to be explored and conceptualised equally. OBJECTIVE: to elicit what matters to very old people regarding ambulatory health and oral healthcare. METHODS: interviews were conducted with non-institutionalised people aged 80 and over living in the area of Cologne, Germany. They were interviewed regarding their experiences of and views on ambulatory healthcare and oral healthcare care, respectively. Thematic analysis was performed to understand their motives and elicit relevant characteristics of desirable health services. RESULTS: from the interviews with 22 participants, 16 characteristics of good healthcare were described. These were generally similar for both general and oral healthcare and had a particular focus on patient-provider interaction and the organisation of care. However, regarding oral healthcare, the participants focused more strongly on the technical-medical skills of professionals and the perceptible treatment results and were more concerned about costs. It was noticeable that older people had the urge to differentiate themselves from 'others unnecessarily using health services'. They were unaware of possible future oral health deterioration and the resulting future needs. CONCLUSIONS: characteristics of good health and oral healthcare from the perspective of older people should be incorporated to ensure patient-centredness in care models. Older patients, as well as healthcare providers, need to be sensitised to their oral health needs to realise comprehensive healthcare.

A time-driven activity-based costing approach of magnetic resonance-guided high-intensity focused ultrasound for cancer-induced bone pain.

OBJECTIVE: To determine resource consumption and total costs for providing magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) treatment to a patient with cancer-induced bone pain (CIBP). METHODS: We conducted a time-driven activity-based costing (TD-ABC) of MR-HIFU treatments for CIBP from a hospital perspective. A European care-pathway (including a macro-, meso-, and micro-level) was designed to incorporate the care-delivery value chain. Time estimates were obtained from medical records and from prospective direct observations. To calculate the capacity cost rate, data from the controlling department of a German university hospital were allocated to the modules of the care pathway. Best- and worst-case scenarios were calculated by applying lower and upper bounds of time measurements. RESULTS: The macro-level care pathway consisted of eight modules (i.e., outpatient consultations, pretreatment imaging, preparation, optimization, sonication, post-treatment, recovery, and anesthesia). The total cost of an MR-HIFU treatment amounted to €5147 per patient. Best- and worst-case scenarios yielded a total cost of €4092 and to €5876. According to cost categories, costs due to equipment accounted for 41% of total costs, followed by costs with personnel (32%), overhead (16%) and materials (11%). CONCLUSION: MR-HIFU is an emerging noninvasive treatment for alleviating CIBP, with increasing evidence on treatment efficacy. This costing study can support MR-HIFU reimbursement negotiations and facilitate the adoption of MR-HIFU as first-line treatment for CIBP. The present TD-ABC model creates the opportunity of benchmarking the provision of MR-HIFU to bone tumor.Key pointsMagnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) is an emerging noninvasive treatment modality for alleviating cancer-induced bone pain (CIBP).From a hospital perspective, the total cost of MR-HIFU amounted to €5147 per treatment.This time-driven activity-based costing model creates the opportunity of benchmarking the provision of MR-HIFU to bone tumor.

Which features of ambulatory healthcare are preferred by people aged 80 and over? Findings from a systematic review of qualitative studies and appraisal of confidence using GRADE-CERQual.

BACKGROUND: Despite healthcare providers' goal of patient-centeredness, current models for the ambulatory (i.e., outpatient) care of older people have not as yet systematically incorporated their views. Moreover, there is no systematic overview of the preferable features of ambulatory care from the perspective of people aged 80 and over. Therefore, the aim of this study was to summarize their specific wishes and preferences regarding ambulatory care from qualitative studies. METHODS: The study was based on qualitative studies identified in a prior systematic review. Firstly, the findings of the qualitative studies were meta-summarized, following Sandelowski and Barroso. Secondly, a list of preferred features of care from the perspective of older people was derived from the included studies' findings through inductive coding. Thirdly, the review findings were appraised using the GRADE-CERQual tool to determine the level of confidence in the qualitative evidence. The appraisal comprised four domains: methodological limitations, coherence, data adequacy, and data relevance. Two reviewers independently evaluated every review finding in each domain. The final appraisals were discussed and ultimately summarized for the respective review finding (high, moderate, low, or very low confidence). RESULTS: The 22 qualitative studies included in the systematic review were mainly conducted in Northern and Western Europe (n = 15). In total, the studies comprised a sample of 330 participants (n = 5 to n = 42) with a mean or median age of 80 and over. From the studies' findings, 23 preferred features of ambulatory care were identified. Eight features concerned care relationships (e.g., "Older people wish to receive personal attention"), and 15 features concerned healthcare structures (e.g., "Older want more time for their care"). The findings emphasized that older people wish to build strong relationships with their care providers. The majority of the review findings reached a moderate or high confidence appraisal. CONCLUSIONS: While the listed features of healthcare structures are common elements of care models for older people (e.g., Geriatric Care Model), aspects of care relationships are somewhat underrepresented or are not addressed explicitly at all. Future research should further explore the identified preferred features and their impact on patient and care outcomes.

Quality of care in the last year of life: adaptation and validation of the German "Views of Informal Carers' Evaluation of Services - Last Year of Life - Cologne".

BACKGROUND: To inform quality improvement and strengthen services provided in the last year of life, measuring quality of care is essential. For Germany, data on care experiences in the last year of life that go beyond diagnoses and care settings are still rare. The aim of this study was to develop and validate a German version of the 'Views of Informal Carers' Evaluation of Services - Short Form (VOICES-SF)' suitable to assess the quality of care and services received across settings and healthcare providers in the German setting in the last year of life (VOICES-LYOL-Cologne). METHODS: VOICES-SF was adapted and translated following the 'TRAPD' team approach. Data collected in a retrospective cross-sectional survey with bereaved relatives in the region of Cologne, Germany were used to assess validity and reliability. RESULTS: Data from 351 bereaved relatives of adult decedents were analysed. The VOICES-LYOL-Cologne demonstrated construct validity in performing according to expected patterns, i.e. correlation of scores to care experiences and significant variability based on care settings. It further correlated with the PACIC-S9 Proxy, indicating good criterion validity. The newly added scale "subjective experiences of process and outcome of care in the last year of life" showed good internal consistency for each given care setting, except for the homecare setting. Test-retest analyses revealed no significant differences in satisfaction ratings according to the length of time since the patient's death. Overall, our data demonstrated the feasibility of collecting patient care experiences reported by proxy-respondents across multiple care settings. CONCLUSION: VOICES-LYOL-Cologne is the first German instrument to analyse care experiences in the last year of life in a comprehensive manner and encourages further research in German-speaking countries. This instrument enables the comparison of quality of care between settings and may be used to inform local and national quality improvement activities. TRIAL REGISTRATION: This study was registered in the German Clinical Trials Register (DRKS00011925; Date of registration: 13/06/2017).

Integrated, cross-sectoral psycho-oncology (isPO): a new form of care for newly diagnosed cancer patients in Germany.

BACKGROUND: The annual incidence of new cancer cases has been increasing worldwide for many years, and is likely to continue to rise. In Germany, the number of new cancer cases is expected to increase by 20% until 2030. Half of all cancer patients experience significant emotional and psychosocial distress along the continuum of their disease, treatment, and aftercare, and also as long-term survivors. Consequently, in many countries, psycho-oncological programs have been developed to address this added burden at both the individual and population level. These programs promote the active engagement of patients in their cancer therapy, aftercare and survivorship planning and aim to improve the patients' quality of life. In Germany, the "new form of care isPO" ("nFC-isPO"; integrated, cross-sectoral psycho-oncology/integrierte, sektorenübergreifende Psycho-Onkologie) is currently being developed, implemented and evaluated. This approach strives to accomplish the goals devised in the National Cancer Plan by providing psycho-oncological care to all cancer patients according to their individual healthcare needs. The term "new form of care" is defined by the Innovation Fund (IF) of Germany's Federal Joint Committee as "a structured and legally binding cooperation between different professional groups and/or institutions in medical and non-medical care". The nFC-isPO is part of the isPO project funded by the IF. It is implemented in four local cancer centres and is currently undergoing a continuous quality improvement process. As part of the isPO project the nFC-isPO is being evaluated by an independent institution: the Institute for Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), University of Cologne, Germany. The four-year isPO project was selected by the IF to be eligible for funding because it meets the requirements of the federal government's National Cancer Plan (NCP), in particular, the "further development of the oncological care structures and quality assurance" in the psycho-oncological domain. An independent evaluation is required by the IF to verify if the new form of care leads to an improvement in cross-sectoral care and to explore its potential for permanent integration into the German health care system. METHODS: The nFC-isPO consists of six components: a concept of care (C1), care pathways (C2), a psycho-oncological care network (C3), a care process organization plan (C4), an IT-supported documentation and assistance system (C5) and a quality management system (C6). The two components concept of care (C1) and care pathways (C2) represent the isPO clinical care program, according to which the individual cancer patients are offered psycho-oncological services within a period of 12 months after program enrolment following the diagnosis of cancer. The remaining components (C3-C6) represent the formal-administrative aspects of the nFC-isPO that are intended to meet the legally binding requirements of patient care in the German health care system. With the aim of systematic development of the nFC-isPO while at the same time enabling the external evaluators to examine its quality, effectiveness and efficiency under conditions of routine care, the project partners took into consideration approaches from translational psycho-oncology, practice-based health care research and program theory. In order to develop a structured, population-based isPO care program, reference was made to a specific program theory, to the stepped-care approach, and also to evidence-based guideline recommendations. RESULTS: The basic version, nFC-isPO, was created over the first year after the start of the isPO project in October 2017, and has since been subject to a continuous quality improvement process. In 2019, the nFC-isPO was implemented at four local psycho-oncological care networks in the federal state North Rhine-Westphalia, in Germany. The legal basis of the implementation is a contract for "special care" with the German statutory health insurance funds according to state law (§ 140a SCB V; Social Code Book V for the statutory health insurance funds). Besides the accompanying external evaluation by the IMVR, the nFC-isPO is subjected to quarterly internal and cross-network quality assurance and improvement measures (internal evaluation) in order to ensure continuous quality improvement process. These quality management measures are developed and tested in the isPO project and are to be retained in order to ensure the sustainability of the quality of nFC-isPO for later dissemination into the German health care system. DISCUSSION: Demands on quality, effectiveness and cost-effectiveness of in the German health care system are increasing, whereas financial resources are declining, especially for psychosocial services. At the same time, knowledge about evidence-based screening, assessment and intervention in cancer patients and about the provision of psychosocial oncological services is growing continuously. Due to the legal framework of the statutory health insurance in Germany, it has taken years to put sound psycho-oncological findings from research into practice. Ensuring the adequate and sustainable financing of a needs-oriented, psycho-oncological care approach for all newly diagnosed cancer patients, as required by the NCP, may still require many additional years. The aim of the isPO project is to develop a new form of psycho-oncological care for the individual and the population suffering from cancer, and to provide those responsible for German health policy with a sound basis for decision-making on the timely dissemination of psycho-oncological services in the German health care system. TRIAL REGISTRATION: The study was pre-registered at the German Clinical Trials Register (https://www.drks.de/DRKS00015326) under the following trial registration number: DRKS00015326 ; Date of registration: October 30, 2018.

Medical knowledge and information needs among women with pathogenic variants in moderate-risk genes for hereditary breast cancer attending genetic counseling at an academic hospital in Germany-A qualitative approach.

With 69,000 newly diagnosed cases every year, breast cancer (BC) is the most frequent cancer disease among women in Germany. Familial clustering is seen in about 30% of newly diagnosed cases. Besides the high-risk genes BRCA1/2, there are also moderate-risk BC genes (MBCG) that are associated with a 20%-50% risk of BC, such as CHEK2, ATM, and PALB2. In Germany, carriers of pathogenic variants in MBCG receive specific information on their test results, individual risks, and preventive options during genetic counseling for the disclosure of the results in a specialized center. Little is known about the medical knowledge that women have after attending counseling. This study aims to identify the medical knowledge, further information needs, and the possible impact of a lack of information on dealing with everyday life for women with pathogenic variants in MBCG who have attended genetic counseling at an academic hospital in Germany. Problem-centered, guided, individual interviews were conducted with twelve women carrying pathogenic variants in MBCG. The interview guide was developed based on the methods of the problem-centered interview according to Witzel. The interview analysis was based on Mayring's qualitative content analysis. The women were between 29 and 59 years old and carried pathogenic variants in the risk genes CHEK2 (n = 8), ATM (n = 1), or PALB2 (n = 3). Several medical uncertainties and information needs emerged from the data, concerning (a) medical terms, (b) risk perception, (c) BC therapy for hereditary BC, (d) lifestyle advice and risk factors, and (e) family planning and risk-reducing mastectomy. Women with pathogenic variants in MBCG might develop their own conceptions regarding the onset of disease and inheritance. In order to meet the need for information and address the uncertainties that may still exist after genetic counseling, structured, evidence-based and comprehensible written information in German should be developed for this group.

[DNVF Memorandum Health Literacy (Part 2) - Operationalisation and Measuring of Health Literacy from a Health Services Research Perspective]. / DNVF Memorandum Gesundheitskompetenz (Teil II) ­ Operationalisierung und Messung von Gesundheitskompetenz aus Sicht der Versorgungsforschung.

The "DNVF Memorandum Health Literacy (Part 2): Operationalization and Measurement of Health Literacy from the Perspective of Health Services Research" of the German Network for Health Services Research represents the continuation of the memorandum "DNVF Memorandum Health Literacy (Part 1): Background, Subject and Issues in Health Services Research". In addition to the general requirements for the measurement of health literacy, this memorandum also deals with the specific requirements, such as the differentiation of health literacy from related constructs, the differences between performance-based and self-assessment methods, the differences between generic and specific instruments, the use of screening instruments, and the measurement of health literacy in special populations. Furthermore, special considerations about the measurement of digital health literacy, potentials of qualitative and participatory research approaches as well as research ethics in the measurement of health literacy will be elaborated on. A special emphasis is placed on practical relevance for health services researchers. Finally, the authors will give an outlook on challenges and research desiderata in connection with the measurement of health literacy in the context of health services research.

Nurse-led decision coaching by specialized nurses for healthy BRCA1/2 gene mutation carriers - adaptation and pilot testing of a curriculum for nurses: a qualitative study.

BACKGROUND: Women with BRCA1/2 mutations are at high risk to develop breast and ovarian cancer. To support these women to participate in shared decision-making, structured nurse-led decision coaching combined with an evidence-based decision aid may be employed. In preparation of the interprofessional randomized controlled trial to evaluate a decision coaching program to support preventive decisions of healthy female BRCA 1/2 gene mutation carriers (EDCP-BRCA), we adapted and piloted an existing training program for specialized nurses and included elements from an existing physician communication training. METHODS: The training was adapted according to the six-step-approach for medical curriculum development. The educational design is based on experience- and problem-based learning. Subsequently, we conducted a qualitative pilot study. Nurses were recruited from six German centers for familial breast and ovarian cancer. The acceptability and feasibility were assessed by structured class observations, field notes and participants' feedback. Data were analyzed using qualitative content analysis. The training was revised according to the results. Due to the COVID-19 pandemic, the patient intervention was adapted as a virtual coaching and a brief additional training for nurses was added. RESULTS: The training consists of two modules (2 + 1 day) that teach competences in evidence-based medicine and patient information, (risk) communication and decision coaching. One pilot test was conducted with six nurses of which three were specialized and experienced in patient counselling. A final set of eight main categories was derived from the data: framework conditions; interaction; schedule, transparency of goals, content, methods, materials and practical relevance and feasibility. Overall, the training was feasible and comprehensible. Decision coaching materials were awkward to handle and decision coaching role plays were set too short. Therefore, materials will be sent out in advance and the training was extended. CONCLUSIONS: Specialized nurses are rarely available and nurse-led counselling is not routinely implemented in the centers of familial breast and ovarian cancer. However, training of less qualified nurses seems feasible. Decision coaching in a virtual format seems to be a promising approach. Further research is needed to evaluate its feasibility, acceptability and effectiveness. TRIAL REGISTRATION: The main trial is registered under DRKS-ID: DRKS00015527 .

Cost-Effectiveness of Targeted Genetic Testing for Breast and Ovarian Cancer: A Systematic Review.

BACKGROUND: Targeted genetic testing is a tool to identify women at increased risk of gynaecological cancer. OBJECTIVE: This systematic review evaluates the results and quality of cost-effectiveness modeling studies that assessed targeted genetic-based screen-and-treat strategies to prevent breast and ovarian cancer. METHODS: Using MEDLINE and databases of the Centre for Reviews and Dissemination, we searched for health economic modeling evaluations of targeted genetic-based screen-and-treat strategies to prevent inheritable breast and ovarian cancer (until August 2020). The incremental cost-effectiveness ratios (ICERs) were compared. Methodological variations were addressed by evaluating the model conceptualizations, the modeling techniques, parameter estimation and uncertainty, and transparency and validation of the models. Additionally, the reporting quality of each study was assessed. RESULTS: Eighteen studies met our inclusion criteria. From a payer perspective, the ICERs of (1) BRCA screening for high-risk women without cancer ranged from dominating the no test strategy to an ICER of $21 700/quality-adjusted life years (QALY). In studies that evaluated (2) BRCA cascade screening (ie, screening of women with cancer plus their unaffected relatives) compared with no test, the ICERs were between $6500/QALY and $50 200/QALY. Compared with BRCA alone, (3) multigene testing in women without cancer had an ICER of $51 800/QALY (one study), while for (4) multigene-cascade screening the ICERs were $15 600/QALY, $56.500/QALY, and $69 600/QALY for women in the United Kingdom, Norway, and the United States, respectively (2 studies). More recently published studies showed a higher methodological and reporting quality. CONCLUSIONS: Targeted BRCA or multiple gene screening is likely to be cost-effective. Methodological variations could be decreased by the development of a reference model, which may serve as a tool for validation of present and future cost-effectiveness models.

Cost-effectiveness of group-based exercise to prevent falls in elderly community-dwelling people.

BACKGROUND: Clinical studies indicate that strength-balance training for active fall prevention can prevent fractures in older people. The present modelling study evaluates the cost-effectiveness of fall prevention exercise (FPE) provided to independently living older people compared to no intervention in Germany. METHOD: We designed a Markov model to evaluate the cost-effectiveness of a group-based FPE-program provided to independently living people ≥75 years from the perspective of the German statutory health insurance (SHI). Input data was obtained from public databases, clinical trials and official statistics. The incremental cost-effectiveness ratio (ICER) was presented as costs per avoided hip fracture. Additionally, we performed deterministic and probabilistic sensitivity analyses and, estimated monetary consequences for the SHI in a budget impact analysis (BIA). RESULTS: For women, the costs per hip fracture avoided amounted to €52,864 (men: €169,805). Results of deterministic and probabilistic sensitivity analyses confirmed the robustness of the results. According to the BIA, for the reimbursement of FPE additional costs of €3.0 million (women) and €7.8 million (men) are expected for the SHI. CONCLUSIONS: Group-based FPE appears to be no cost-effective option to prevent fall-related hip fractures in independently living elderly. To allow a more comprehensive statement on the cost effectiveness of FPE fracture types other than hip should be increasingly evaluated in clinical trials.

Methodological issues in economic evaluations of disease prevention and health promotion: an overview of systematic and scoping reviews.

BACKGROUND: We aimed to provide a comprehensive overview of methodological challenges in economic evaluations of disease prevention and health promotion (DPHP)-measures. METHODS: We conducted an overview of reviews searching MEDLINE, EMBASE, NHS Economic Evaluation Database, Database of Promoting Health Effectiveness Reviews, Cochrane Database of Systematic Reviews (CDSR) and Database of Promoting Health Effectiveness Reviews (DOPHER) (from their inception to October 2021). We included both systematic and scoping reviews of economic evaluations in DPHP addressing following methodological aspects: (i) attribution of effects, (ii) outcomes, (iii) inter-sectoral (accruing to non-health sectors of society) costs and consequences and (iv) equity. Data were extracted according to the associated sub-criteria of the four methodological aspects including study design economic evaluation (e.g. model-based), type/scope of the outcomes (e.g. outcomes beyond health), perspective, cost categories related to non-health sectors of society, and consideration of equity (method of inclusion). Two reviewers independently screened all citations, full-text articles, and extracted data. A narrative synthesis without a meta-analysis or other statistical synthesis methods was conducted. RESULTS: The reviewing process resulted in ten systematic and one scoping review summarizing 494 health economic evaluations. A lifelong time horizon was adopted in about 23% of DPHP evaluations, while 64% of trial-based evaluations had a time horizon up to 2 years. Preference-based outcomes (36%) and non-health outcomes (8%) were only applied in a minority of studies. Although the inclusion of inter-sectoral costs (i.e. costs accruing to non-health sectors of society) has increased in recent years, these were often neglected (between 6 and 23% depending on the cost category). Consideration to equity was barely given in economic evaluations, and only addressed in six of the eleven reviews. CONCLUSIONS: Economic evaluations of DPHP measures give only little attention to the specific methodological challenges related to this area. For future economic DPHP evaluations a tool with structured guidance should be developed. This overview of reviews was not registered and a published protocol does not exist.

A cross-sectional analysis of health literacy: patient- versus family doctor-reported and associations with self-efficacy and chronic disease.

BACKGROUND: Adequate health literacy (HL) levels contribute to good health outcomes and successful disease self-management in patients with chronic disease. Hence, it is essential that family doctors recognize patients with inadequate HL in need of additional support. This study had two aims: (1) to assess and compare patient self-reported versus family doctor-rated HL estimates, and (2) to explore associations between patient-reported HL, self-efficacy and chronic diseases. METHODS: Participants in this cross-sectional survey were recruited through general practices in North Rhine-Westphalia, Germany. Patient self-reported HL was measured using the European Health Literacy Survey-16. Family doctor-rated HL was measured with an adapted version of this instrument. Using crosstabulations patient-reported and family doctor-rated HL estimates were compared for 346 patient-family doctor pairs. Associations between HL, self-efficacy and chronic disease were investigated using regression analyses. RESULTS: Patient-reported and family doctor-rated HL estimates were concordant in 38% of all cases. On average family doctors rated their patients' HL lower than patients rated their own HL. The lower average family doctor ratings were more pronounced when patients were older, male and had more than one chronic disease. Female family doctors rated HL of male patients lower than their male colleagues. Patient reported HL had a significant positive association with self-efficacy. Mediation analysis provided support that self-efficacy acts as mediator between HL and the number of chronic diseases. CONCLUSIONS: Our study findings indicate a significant discrepancy between patients' self-reported HL and externally rated HL by family doctors. A more systematic utilization of HL screeners might help reduce this discrepancy. At the same time, consideration should be given to enhancing communication training for family doctors and addressing critical HL skills in patient education.

Development of decision aids for female BRCA1 and BRCA2 mutation carriers in Germany to support preference-sensitive decision-making.

BACKGROUND: Women with pathogenic BRCA1 and BRCA2 mutations possess a high risk of developing breast and ovarian cancer. They face difficult choices when considering preventive options. This study presents the development process of the first decision aids to support this complex decision-making process in the German healthcare system. METHODS: A six-step development process based on the International Patient Decision Aid Standards was used, including a systematic literature review of existing decision aids, a topical medical literature review, preparation of the decision aids, focus group discussions with women with BRCA1/2 mutations, internal and external reviews by clinical and self-help experts, and user tests. All reviews were followed by iterative revisions. RESULTS: No existing decision aids were transferable to the German setting. The medical research revealed a need to develop separate decision aids for women with BRCA1/2 mutations (A) without a history of cancer (previvors) and (B) with a history of unilateral breast cancer (survivors). The focus group discussions confirmed a high level of approval for the decision aids from both target groups. Additionally, previvors requested more information on risk-reducing breast surgery, risk-reducing removal of both ovaries and Fallopian tubes, and psychological aspects; survivors especially wanted more information on breast cancer on the affected side (e.g. biological parameters, treatment, and risk of recurrence). CONCLUSIONS: In a structured process, two target-group-specific DAs for previvors/survivors with BRCA1/2 mutations were developed to support decision-making on risk-adapted preventive options. These patient-oriented tools offer an important addition to existing specialist medical care in Germany.

Health literacy, mental disorders and fear of progression and their association with a need for psycho-oncological care over the course of a breast cancer treatment.

This studyinvestigates the need for psycho-oncological care over the course of a breast cancer treatment and possible associated factors to develop such a need. The PIAT-Study was a longitudinal postal survey study conducted in Germany (2013 to 2014) with breast cancer patients (BCPs). Patients received a questionnaire at three-time points (T1: few days after surgery, T2: after 10 weeks; T3: after 40 weeks). This study considers information about patients' needs for psycho-oncological care, their breast cancer disease, social support, anxiety, health literacy (HL) and sociodemographic information. Data were analysed with descriptive statistics and logistic regression modelling to estimate the association between a need for psycho-oncological treatment and patient characteristics. N = 927 breast cancer patients reported their psycho-oncological need. 35.2% of patients report at least at one measuring point to be in need for psycho-oncological care. In a multiple logistic regression, noticeable determinants for developing such a need are an inadequateHL(OR = 1.97), fear of progression (FoP) (OR = 2.08) and psychological comorbidities (OR = 8.15) as well as certain age groups. BCPs with a low HL, suffering from a dysfunctional level of FoP or mental disorders are more likely to develop a need for psycho-oncological care.