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).

Decision Coaching for Healthy Women With BRCA1/2 Pathogenic Variants­Findings of the Randomized Controlled EDCP-BRCA Trial.

BACKGROUND: Women with BRCA1/2 pathogenic variants (PVs) have a choice of preventive options. To help these women decide for themselves, we developed and implemented a decision coaching (DC) program and evaluated it for congruence between the participants' desired and actual roles in decision-making. METHODS: Healthy BRCA1/2 PV carriers (from 25 to 60 years of age) were recruited at six centers in Germany. Those returning baseline T1-questionnaires were randomly assigned to the intervention group (IG) or the control group (CG). The IG attended a nurse-led DC program. The primary outcome was congruence between the participants' desired and actual roles in decision-making. The secondary outcomes included an active role, satisfaction, decisional conflict, and knowledge. Follow-up data were obtained by questionnaire at 12 weeks (T2) and 6 months (T3). RESULTS: Of the 413 women who were recruited, 389 returned baseline T1 questionnaires. At T2, the IG and CG groups did not differ significantly in congruence between their desired and actual roles in decision-making (0.12 [95% confidence interval -0.03; 0.28], p=0.128), with a slightly higher congruence in the CG. Women in both groups were more active at T2 than their stated preference at T1, with a notably higher percentage in the IG (IG: 40%, CG: 24.4%; [-25.1; -6.1]). IG participants were more satisfied with the role that they had assumed and had less decisional conflict and greater knowledge. CONCLUSION: These findings imply that this DC program can help women with BRCA1/2 PVs participate actively in decision-making with regard to preventive measures.

Predictors of knowledge and knowledge gain after decision aid use among women with BRCA1/2 pathogenic variants.

OBJECTIVE: To identify factors contributing to baseline knowledge in women with BRCA1/2 pathogenic variants (PVs) and knowledge gain after decision aid (DA) use. METHODS: Women with PVs in BRCA1 or BRCA2 genes were randomly assigned to an intervention group (IG) receiving DAs or a control group (CG). Of the total sample, 417 completed the baseline survey and were included in this analysis. Two multiple regression analyses were conducted: baseline data on socio-demographic, medical, decision-related and psychological variables were used to identify predictors for (1) baseline knowledge within the total group and (2) knowledge gain within the IG after DA use three months post study inclusion. RESULTS: At baseline, higher education status, no breast cancer history, and lower decisional conflict related to higher knowledge within the total group. After DA use within the IG, higher baseline scores for decisional conflict predicted higher knowledge gain, and higher baseline scores for depression and intrusion predicted lower knowledge gain. CONCLUSIONS: This study identified predictors of baseline knowledge and knowledge gain after DA use in women with BRCA1/2 PVs. PRACTICE IMPLICATIONS: Awareness of facilitating and hindering factors on these women's knowledge can improve understanding of their health literacy and enable further targeted support interventions.

Personalized, interdisciplinary patient pathway for cross-sector care of multimorbid patients (eliPfad trial): study protocol for a randomized controlled trial.

BACKGROUND: Multimorbid and frail elderly patients often carry a high burden of treatment. Hospitalization due to the onset of an acute illness can disrupt the fragile balance, resulting in further readmissions after hospital discharge. Current models of care in Germany do not meet the needs of this patient group. Rather lack of coordination and integration of care combined with a lack of interdisciplinary approaches result in fragmented and inadequate care and increase the burden of treatment even more. METHODS: eliPfad is a randomized controlled trial conducted in 6 hospitals in Germany. Multimorbid elderly patients aged 55 or older are randomly assigned to the intervention or control group. Patients in the intervention group receive the eliPfad intervention additional to standard care. The core components of eliPfad are: Early assessment of patients' individual treatment burden and support through a specially trained case manager Involvement of the patient's general practitioner (GP) right from the beginning of the hospital stay Preparation of an individual, cross-sectoral treatment plan through the interdisciplinary hospital team with the involvement of the patient's GP Establishment of a cross-sectoral electronic patient record (e-ePA) for documentation and cross-sectoral exchange Support/Promote patient adherence Tailored early rehabilitation during the hospital stay, which is continued at home Close-tele-monitoring of medically meaningful vital parameters through the use of tablets, digital devices, and personal contacts in the home environment The intervention period begins in the hospital and continues 6 weeks after discharge. Patients in the control group will be treated according to standard clinical care and discharged according to current discharge management. The primary aim is the prevention/reduction of readmissions in the first 6 months after discharge. In addition, the impact on health-related quality of life, the burden of treatment, survival, self-management, medication prescription, health literacy, patient-centered care, cost-effectiveness, and process evaluation will be examined. Nine hundred forty-eight patients will be randomized 1:1 to intervention and control group. DISCUSSION: If eliPfad leads to fewer readmissions, proves (cost-)effective, and lowers the treatment burden, it should be introduced as a new standard of care in the German healthcare system. TRIAL REGISTRATION: The trial was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) on 08/14/2023 under the ID DRKS00031500 .

Cost-Effectiveness Analyses of Non-Pharmacological and Non-Surgical Interventions in Idiopathic Parkinson's Disease: A Systematic Review.

Background: Interest in non-pharmacological/non-surgical interventions to treat Parkinson's disease (PD) has substantially increased. Although a few health-economic studies have been conducted, summary information on the cost-effectiveness is still scarce. Objective: To give an overview of cost-effectiveness analyses (CEA) focusing on non-pharmacological/non-surgical interventions in PD patients. Methods: A systematic literature search was conducted in five databases. Studies were included that provided cost-effectiveness analysis (CEA) or cost-utility analysis (CUA) of non-pharmacological/non-surgical interventions in PD patients. Study quality was assessed with the Drummond and CHEERS 2022 checklists respectively, for economic evaluation. Results: N = 9 studies published between 2012-2023 were identified. Most studies undertook a CUA (n = 5); n = 3 reported a combination of CEA and CUA, and n = 1 a pure CEA. Most studies (n = 6) examined physical exercise. The CEA studies identified additional costs of 170€ -660€  for the improvement of one single unit of a clinical outcome and savings of 18.40€ -22.80€  per score gained as measured with established instruments. The four studies that found significant quality of life benefits show large variations in the incremental cost effectiveness ratio (ICER) of 3,220€ -214,226€  per quality-adjusted life year (QALY); notably interventions were heterogenous regarding content and intensity. Conclusions: Despite increasing numbers of non-pharmacological/non-surgical intervention trials in PD patients, health-economic evaluations are rare. The examined intervention types and health-economic results vary greatly. Together with the heterogeneity of the health-economic studies these factors limit the conclusions that can be drawn. Further research and a standardization of methods is needed to allow decision makers to make meaningful interpretations, and to allocate scarce resources.

Health economic consequences of optimal vs. observed guideline adherence of coronary angiography in patients with suspected obstructive stable coronary artery in Germany: a microsimulation model.

AIMS: While the number of patients with stable coronary artery disease (SCAD) is similar across European countries, Germany has the highest per capita volume of coronary angiographies (CA). This study evaluated the health economic consequences of guideline-non-adherent use of CA in patients with SCAD. METHODS AND RESULTS: As part of the ENLIGHT-KHK trial, a prospective observational study, this microsimulation model compared the number of major adverse cardiac events (MACE) and the costs of real-world use of CA with those of (assumed) complete guideline-adherent use (according to the German National Disease Management Guideline 2019). The model considered non-invasive testing, CA, revascularization, MACE (30 days after CA), and medical costs. Model inputs were obtained from the ENLIGHT-KHK trial (i.e. patients' records, a patient questionnaire, and claims data). Incremental cost-effectiveness ratios were calculated by comparing the differences in costs and MACE avoided from the perspective of the Statutory Health Insurance (SHI). Independent on pre-test probability (PTP) of SCAD, complete guideline adherence for usage of CA would result in a slightly lower rate of MACE (-0.0017) and less cost (€-807) per person compared with real-world guideline adherence. While cost savings were shown for moderate and low PTP (€901 and €502, respectively), for a high PTP, a guideline-adherent process results in slightly higher costs (€78) compared with real-world guideline adherence. Sensitivity analyses confirmed the results. CONCLUSION: Our analysis indicates that improving guideline adherence in clinical practice by reducing the amount of CAs in patients with SCAD would lead to cost savings for the German SHI.

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.

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.

Testing a single item screener to support family doctors in identifying patients with limited health literacy: convergent validity of the SILS and the HLS-EU-Q16.

BACKGROUND: Low health literacy (HL) is associated with reduced disease self-management skills, worse health outcomes, an increased number of hospitalizations, more frequent use of the emergency room and less utilization of preventive services. To support patients with low HL it is crucial to identify affected patients. HL is a multidimensional construct, which covers different skills and abilities to make informed health decisions. Validated brief screening tools to assess health-literacy-related skills or abilities in primary care settings are currently not available in German. This study aimed to validate a single item screener developed in the US for the German primary care setting. METHODS: Our study used cross-sectional data from a survey among mainly chronically ill patients (n = 346) conducted in family practices in the state of North Rhine-Westphalia. We explored the convergent validity between a single item literacy screener (SILS) and the HLS-EU-Q16. The SILS measures functional HL by asking patients about their need for help when reading information materials. The HLS-EU-Q16 is a multidimensional HL measure frequently used for research purposes in Germany. Associations between the two instruments were examined using Spearman's correlations and regression analyses. The diagnostic performance of the SILS relative to the HLS-EU-Q16 was assessed using receiver operator curves (ROC). RESULTS: The SILS had a statistically significant correlation with the HLS-EU-Q16 (Spearman ρ: 0.35) and explained 26% of its total variance. Stratified analyses of the convergent validity between both instruments by age, sex, migration background, education level and chronic disease status showed moderate statistically significant correlations in all subgroups (range: 0.223 to 0.428). With an area under the curve of 0.66, the receiver operator curve indicated a satisfactory diagnostic performance of the SILS relative to the HLS-EU-Q16. CONCLUSIONS: The SILS provided an acceptable initial assessment of HL limitations among a heterogeneous population of mainly chronically ill patients in a primary care setting. With only one item, the SILS can be a short and effective tool for routine use in primary care and specialized care settings. Future research should test the SILS in other populations and pilot applications of the SILS in routine care.

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).

Cost-effectiveness of WEB Embolization, Coiling and Stent-assisted Coiling for the Treatment of Unruptured Intracranial Aneurysms.

PURPOSE: Information about the cost-effectiveness of a certain treatment is relevant for decision-making and healthcare providers. This study compares the cost-effectiveness of the novel Woven Endobridge (WEB) for intracranial aneurysm treatment with conventional coiling and stent-assisted coiling (SAC) from the perspective of the German Statutory Health Insurance. METHODS: A patient-level simulation was constructed to simulate 55-year-old patients with an unruptured middle cerebral artery aneurysm (size: 3-11 mm) considering WEB treatment, coiling or SAC in terms of morbidity, angiographic outcome, retreatment, procedural and rehabilitation costs and rupture rates. Incremental cost-effectiveness ratios (ICERs) were calculated as costs per quality-adjusted life years (QALYs) and costs per year with neurologic morbidity avoided. Uncertainty was explored with deterministic and probabilistic sensitivity analyses. The majority of data were obtained from prospective multi-center studies and meta-analyses of non-randomized studies. RESULTS: In the base case, lifetime QALYs were 13.24 for the WEB, 12.92 for SAC and 12.68 for coiling. Lifetime costs were 20,440 € for the WEB, 23,167 € for SAC, and 8200 € for coiling. Compared to coiling, the ICER for the WEB was 21,826 €/QALY, while SAC was absolutely dominated by WEB. Probabilistic sensitivity analysis revealed that at a willingness-to-pay of ≥ 30,000 €/QALY, WEB was the preferred treatment. Deterministic sampling showed that the discount rate, material costs and retreatment rates had the largest impact on the ICERs. CONCLUSION: The novel WEB showed at least comparable cost-effectiveness to SAC for treatment of broad-based unruptured aneurysms. Considering all three modalities, coiling had the least costs; however this modality is often not appropriate for the treatment of wide-necked aneurysms.

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.

Assessing Psychological Morbidity in Cancer-Unaffected BRCA1/2 Pathogenic Variant Carriers: A Systematic Review.

Female BRCA1/2 pathogenic variant carriers have an increased lifetime risk for breast and ovarian cancer. Cancer-unaffected women who are newly diagnosed with this pathogenic variant may experience psychological distress because of imminent health threat. No comprehensible review on psychological morbidity in cancer-unaffected BRCA1/2 pathogenic variant carriers is currently available. This review aims to give an overview about all available the studies in which psychological outcomes have been assessed in cancer-unaffected BRCA1/2 pathogenic variant carriers, whether as a primary outcome or secondary measurement. A systematic search across four databases (Web of Science, PubMed, ScienceDirect, and EBSCO) was conducted. Studies had to report on cancer-unaffected pathogenic variant carriers (exclusively or separately) and use a validated measure of psychological morbidity to be eligible. Measures were only included if they were used in at least three studies. The final review consisted of 45 studies from 13 countries. Distress measures, including anxiety and cancer worry, were most often assessed. Most studies found a peak of distress immediately after genetic test result disclosure, with a subsequent decline over the following months. Only some studies found elevated distress in carriers compared to non-carriers in longer follow-ups. Depression was frequently investigated but largely not found to be of clinical significance. Quality of life seemed to be largely unaffected by a positive genetic test result, although there was some evidence that younger women, especially, were less satisfied with their role functioning in life. Body image has been infrequently assessed so far, but the evidence suggested that there may be a decrease in body image after genetic test result disclosure that may decrease further for women who opt for a prophylactic mastectomy. Across all the outcomes, various versions of instruments were used, often limiting the comparability among the studies. Hence, future research should consider using frequently used instruments, as outlined by this review. Finally, while many studies included cancer-unaffected carriers, they were often not reported on separately, which made it difficult to draw specific conclusions about this population.

Transforming Health Care Delivery towards Value-Based Health Care in Germany: A Delphi Survey among Stakeholders.

Value-based healthcare (VBC) represents one strategy to meet growing challenges in healthcare systems. To date, VBC is not implemented broadly in the German healthcare system. A Delphi survey was conducted to explore stakeholders' perspectives on the relevance and feasibility of actions and practices related to the implementation of VBC in the German healthcare system. Panellists were selected using purposive sampling. Two iterative online survey rounds were conducted which were preceded by a literature search and semi-structured interviews. After two survey rounds, a consensus was reached on 95% of the items in terms of relevance and on 89% of the items regarding feasibility. The expert panels' responses were in favor of the presented actions and practices of VBC in 98% of items for which consensus was found (n = 101). Opposition was present regarding the relevance of health care being provided preferably in one location for each indication. Additionally, the panel considered inter-sectoral joint budgets contingent on treatment outcomes achieved as not feasible. When planning the next steps in moving towards a value-based healthcare system, policymakers should take into account this study's results on stakeholders' perceptions of the relative importance and feasibility of VBC components. This ensures that regulatory changes are aligned with stakeholder values, facilitating greater acceptance and more successful implementation.

Effect of opioids for breathlessness in heart failure: a systematic review and meta-analysis.

BACKGROUND: For the treatment of breathlessness in heart failure (HF), most textbooks advocate the use of opioids. Yet, meta-analyses are lacking. METHODS: A systematic review was performed for randomised controlled trials (RCTs) assessing effects of opioids on breathlessness (primary outcome) in patients with HF. Key secondary outcomes were quality of life (QoL), mortality and adverse effects. Cochrane Central Register of Controlled Trials, MEDLINE and Embase were searched in July 2021. Risk of bias (RoB) and certainty of evidence were assessed by the Cochrane RoB 2 Tool and Grading of Recommendations Assessment, Development and Evaluation criteria, respectively. The random-effects model was used as primary analysis in all meta-analyses. RESULTS: After removal of duplicates, 1180 records were screened. We identified eight RCTs with 271 randomised patients. Seven RCTs could be included in the meta-analysis for the primary endpoint breathlessness with a standardised mean difference of 0.03 (95% CI -0.21 to 0.28). No study found statistically significant differences between the intervention and placebo. Several key secondary outcomes favoured placebo: risk ratio of 3.13 (95% CI 0.70 to 14.07) for nausea, 4.29 (95% CI 1.15 to 16.01) for vomiting, 4.77 (95% CI 1.98 to 11.53) for constipation and 4.42 (95% CI 0.79 to 24.87) for study withdrawal. All meta-analyses revealed low heterogeneity (I2 in all these meta-analyses was <8%). CONCLUSION: Opioids for treating breathlessness in HF are questionable and may only be the very last option if other options have failed or in case of an emergency. PROSPERO REGISTRATION NUMBER: CRD42021252201.

Integrated care for older multimorbid heart failure patients: protocol for the ESCAPE randomized trial and cohort study.

ESCAPE: Evaluation of a patient-centred biopsychosocial blended collaborative care pathway for the treatment of multimorbid elderly patients. THERAPEUTIC AREA: Healthcare interventions for the management of older patients with multiple morbidities. AIMS: Multi-morbidity treatment is an increasing challenge for healthcare systems in ageing societies. This comprehensive cohort study with embedded randomized controlled trial tests an integrated biopsychosocial care model for multimorbid elderly patients. HYPOTHESIS: A holistic, patient-centred pro-active 9-month intervention based on the blended collaborative care (BCC) approach and enhanced by information and communication technologies can improve health-related quality of life (HRQoL) and disease outcomes as compared with usual care at 9 months. METHODS: Across six European countries, ESCAPE is recruiting patients with heart failure, mental distress/disorder plus ≥2 medical co-morbidities into an observational cohort study. Within the cohort study, 300 patients will be included in a randomized controlled assessor-blinded two-arm parallel group interventional clinical trial (RCT). In the intervention, trained care managers (CMs) regularly support patients and informal carers in managing their multiple health problems. Supervised by a clinical specialist team, CMs remotely support patients in implementing the treatment plan-customized to the patients' individual needs and preferences-into their daily lives and liaise with patients' healthcare providers. An eHealth platform with an integrated patient registry guides the intervention and helps to empower patients and informal carers. HRQoL measured with the EQ-5D-5L as primary endpoint, and secondary outcomes, that is, medical and patient-reported outcomes, healthcare costs, cost-effectiveness, and informal carer burden, will be assessed at 9 and ≥18 months. CONCLUSIONS: If proven effective, the ESCAPE BCC intervention can be implemented in routine care for older patients with multiple morbidities across the participating countries and beyond.

Methods for assessing guideline adherence for invasive procedures in the care of chronic coronary artery disease: a scoping review.

OBJECTIVES: In the care of coronary artery disease (CAD), evidence questions the adequate application of guidelines for cardiovascular procedures, particularly coronary angiographies (CA) and myocardial revascularisation. This review aims to examine how care providers' guideline adherence for CA and myocardial revascularisation in the care of chronic CAD was assessed in the literature. DESIGN: Scoping review. DATA SOURCES: PubMed and EMBASE were searched through in June 2021 (rerun in September 2022). ELIGIBILITY CRITERIA: We included studies assessing care providers' adherence to evidence-based guidelines for CA or myocardial revascularisation in the care of chronic CAD. Studies had to list the evaluation of guideline adherence as study objective, describe the evaluation methods used and report the underlying guidelines and recommendations. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers used standardised forms to extract study characteristics, methodological aspects such as data sources and variables, definitions of guideline adherence and quantification methods and the extent of guideline adherence. To elucidate the measurement of guideline adherence, the main steps were described. RESULTS: Twelve studies (311 869 participants) were included, which evaluated guideline adherence by (1) defining guideline adherence, (2) specifying the study population, (3) assigning (classes of) recommendations and (4) quantifying adherence. Thereby, primarily secondary data were used. Studies differed in their definitions of guideline adherence, where six studies each considered only recommendation class I/grade A/strong recommendations as adherent or additionally recommendation classes IIa/IIb. Furthermore, some of the studies reported a priori definitions and allocation rules for the assignment of recommendation classes. Guideline adherence results ranged from 10% for percutaneous coronary intervention with prior heart team discussion to 98% for coronary artery bypass grafting. CONCLUSION: Due to remarkable inconsistencies in the assessment, a cautious interpretation of the guideline adherence results is required. Future efforts should endeavour to establish a consistent understanding of the concept of guideline adherence.

Coping Self-Efficacy and Its Relationship with Psychological Morbidity after Genetic Test Result Disclosure: Results from Cancer-Unaffected BRCA1/2 Mutation Carriers.

Women who are found to carry a BRCA1/2 pathogenic variant experience psychological distress due to an increased risk of breast and ovarian cancer. They may decide between different preventive options. In this secondary analysis of data collected alongside a larger randomized controlled trial, we are looking at 130 newly found BRCA1/2 pathogenic variant carriers and how their coping self-efficacy immediately after genetic test result disclosure is related to their psychological burden and status of preventive decision making. Participants received the Coping Self-Efficacy Scale, the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the Decisional Conflict Scale, and the Stage of Decision-Making Scale after positive genetic test result disclosure. We found that women with higher coping self-efficacy showed fewer symptoms of anxiety or depression and were less affected by receiving the genetic test result in terms of post-traumatic stress. However, coping self-efficacy had no relationship with any decision-related criteria, such as decisional conflict or stage of decision making. This shows that despite its buffering capacity on psychological burden, possessing coping self-efficacy does not lead to more decisiveness in preference-sensitive decisions.

Factors Influencing the Adoption of Magnetic Resonance-Guided High-Intensity Focused Ultrasound for Painful Bone Metastases in Europe, A Group Concept Mapping Study.

Magnetic resonance imaging-guided high-intensity focused ultrasound (MR-HIFU) is an innovative treatment for patients with painful bone metastases. The adoption of MR-HIFU will be influenced by several factors beyond its effectiveness. To identify contextual factors affecting the adoption of MR-HIFU, we conducted a group concept mapping (GCM) study in four European countries. The GCM was conducted in two phases. First, the participants brainstormed statements guided by the focus prompt "One factor that may influence the uptake of MR-HIFU in clinical practice is...". Second, the participants sorted statements into categories and rated the statements according to their importance and changeability. To generate a concept map, multidimensional scaling and cluster analysis were conducted, and average ratings for each (cluster of) factors were calculated. Forty-five participants contributed to phase I and/or II (56% overall participation rate). The resulting concept map comprises 49 factors, organized in 12 clusters: "competitive treatments", "physicians' attitudes", "alignment of resources", "logistics and workflow", "technical disadvantages", "radiotherapy as first-line therapy", "aggregating knowledge and improving awareness", "clinical effectiveness", "patients' preferences", "reimbursement", "cost-effectiveness" and "hospital costs". The factors identified echo those from the literature, but their relevance and interrelationship are case-specific. Besides evidence on clinical effectiveness, contextual factors from 10 other clusters should be addressed to support adoption of MR-HIFU.

[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.