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).

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.

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.

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.

[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.

Cost-effectiveness of the MitraClip device in German heart failure patients with secondary mitral regurgitation.

AIM: To evaluate the cost-effectiveness of the MitraClip device (MitraClip) in addition to optimal medical therapy (OMT) in patients with heart failure and secondary mitral regurgitation in Germany. METHODS AND RESULTS: A model-based economic evaluation was performed to estimate the incremental cost per quality-adjusted life-years (QALYs) for patients with a moderate-to-severe or severe secondary mitral regurgitation receiving MitraClip plus OMT compared with OMT alone from the statutory health insurance (SHI) perspective. Transition probabilities, data on survival rates, and hospitalization rates were obtained from the COAPT trial, a randomized-controlled multicenter trial. Data on health utility and costs were taken from published evidence. To assess parameter uncertainty, several deterministic and probabilistic sensitivity analyses were performed. The incremental costs per QALY gained were € 59,728 (costs/incremental life years gained: € 42,360). The results were most sensitive to the transition probabilities and the hospitalization rates. The probabilistic sensitivity analysis showed that the MitraClip strategy was cost-effective with a probability of 80% at a willingness-to-pay threshold of € 67,000/QALY. CONCLUSIONS: Depending on the willingness-to-pay threshold, for patients with heart failure and a moderate-to-severe or severe secondary mitral regurgitation the MitraClip can be cost-effective from the perspective of the German SHI.

Hemodialysis and Peritoneal Dialysis in Germany from a Health Economic View-A Propensity Score Matched Analysis.

BACKGROUND: Hemodialysis (HD) and peritoneal dialysis (PD) are deemed medically equivalent for therapy of end-stage renal disease (ESRD) and reimbursed by the German statutory health insurance (SHI). However, although the home dialysis modality PD is associated with higher patient autonomy than HD, for unknown reasons, PD uptake is low in Germany. Hence, we compared HD with PD regarding health economic outcomes, particularly costs, as potentially relevant factors for the predominance of HD. METHODS: Claims data from two German health insurance funds were analysed in a retrospective cohort study regarding the prevalence of HD and PD in 2013-2016. Propensity score matching created comparable HD and PD groups (n = 436 each). Direct annual health care costs were compared. A sensitivity analysis included a comparison of different matching techniques and consideration of transportation costs. Additionally, hospitalisation and survival were investigated using Poisson regression and Kaplan-Meier curves. RESULTS: Total direct annual average costs were higher for HD (€47,501) than for PD (€46,235), but not significantly (p = 0.557). The additional consideration of transportation costs revealed an annual cost advantage of €7000 for PD. HD and PD differed non-significantly in terms of hospitalisation and survival rates (p = 0.610/p = 0.207). CONCLUSIONS: PD has a slight non-significant cost advantage over HD, especially when considering transportation costs.

Early economic modeling of magnetic resonance image-guided high intensity focused ultrasound compared to radiotherapy for pain palliation of bone metastases.

Introduction: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) is a non-invasive treatment option for palliative patients with painful bone metastases. Early evidence suggests that MR-HIFU is associated with similar overall treatment response, but more rapid pain palliation compared to external beam radiotherapy (EBRT). This modelling study aimed to assess the cost-effectiveness of MR-HIFU as an alternative treatment option for painful bone metastases from the perspective of the German Statutory Health Insurance (SHI). Materials and methods: A microsimulation model with lifelong time horizon and one-month cycle length was developed. To calculate the incremental cost-effectiveness ratio (ICER), strategy A (MR-HIFU as first-line treatment or as retreatment option in case of persistent pain or only partial pain relief after EBRT) was compared to strategy B (EBRT alone) for patients with bone metastases due to breast, prostate, or lung cancer. Input parameters used for the model were extracted from the literature. Results were expressed as EUR per quality-adjusted life years (QALYs) and EUR per pain response (i.e., months spent with complete or partial pain response). Deterministic and probabilistic sensitivity analyses (PSA) were performed to test the robustness of results, and a value of information analysis was conducted. Results: Compared to strategy B, strategy A resulted in additional costs (EUR 399) and benefits (0.02 QALYs and 0.95 months with pain response). In the base case, the resulting ICERs (strategy A vs. strategy B) are EUR 19,845/QALY and EUR 421 per pain response. Offering all patients MR-HIFU as first-line treatment would increase the ICER by 50% (31,048 EUR/QALY). PSA showed that at a (hypothetical) willingness to pay of EUR 20,000/QALY, the probability of MR-HIFU being cost-effective was 52%. The expected value of perfect information (EVPI) for the benefit population in Germany is approximately EUR 190 Mio. Conclusion: Although there is considerable uncertainty, the results demonstrate that introducing MR-HIFU as a treatment alternative for painful bone metastases might be cost-effective for the German SHI. The high EVPI indicate that further studies to reduce uncertainty would be worthwhile.

Uptake Rates of Risk-Reducing Surgeries for Women at Increased Risk of Hereditary Breast and Ovarian Cancer Applied to Cost-Effectiveness Analyses: A Scoping Systematic Review.

The cost-effectiveness of genetic screen-and-treat strategies for women at increased risk for breast and ovarian cancer often depends on the women's willingness to make use of risk-reducing mastectomy (RRM) or salpingo-oophorectomy (RRSO). To explore the uptake rates of RRM and RRSO applied in health economic modeling studies and the impact of uptake rates on the incremental cost-effectiveness ratios (ICER), we conducted a scoping literature review. In addition, using our own model, we conducted a value of information (VOI) analysis. Among the 19 models included in the review, the uptake rates of RRM ranged from 6% to 47% (RRSO: 10% to 88%). Fifty-seven percent of the models applied retrospective data obtained from registries, hospital records, or questionnaires. According to the models' deterministic sensitivity analyses, there is a clear trend that a lower uptake rate increased the ICER and vice versa. Our VOI analysis showed high decision uncertainty associated with the uptake rates. In the future, uptake rates should be given more attention in the conceptualization of health economic modeling studies. Prospective studies are recommended to reflect regional and national variations in women's preferences for preventive surgery.

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.

Expectations for the Development of Health Technology Assessment in Brazil.

The implementation of health technology assessment (HTA) in emerging countries depends on the characteristics of the health care system and the needs of public health care. The objective of this survey was to investigate experts' expectations for the development of HTA in Brazil and to derive measures to strengthen the impact of HTA in Brazil on health care decisions. Based on a scoping literature review, a questionnaire was developed proposing eight theses for seven domains of HTA: (i) capacity building, (ii) public involvement, (iii) role of cost-effectiveness analysis (CEA), (iv) institutional framework, (v) scope of HTA studies, (vi) methodology of HTA, and (vii) HTA as the basis for jurisdiction. Thirty experts responded in full to the survey and agreed to five of the eight theses proposed. Experts suggested several measures to promote HTA within the scope of each domain, thus addressing capacity building related to HTA, availability, and reliability of population data, and legal endowment of the HTA system. Finally, HTA processes in Brazil should also address public health issues (e.g., appraisal of interventions directed at chronic diseases).

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.

Data on Utility in Cost-Utility Analyses of Genetic Screen-and-Treat Strategies for Breast and Ovarian Cancer.

Genetic screen-and-treat strategies for the risk-reduction of breast cancer (BC) and ovarian cancer (OC) are often evaluated by cost-utility analyses (CUAs). This analysis compares data on health preferences (i.e., utility values) in CUAs of targeted genetic testing for BC and OC. Based on utilities applied in fourteen CUAs, data on utility including related assumptions were extracted for the health states: (i) genetic test, (ii) risk-reducing surgeries, (iii) BC/OC and (iv) post cancer. In addition, information about the sources of utility and the impact on the cost-effectiveness was extracted. Utility for CUAs relied on heterogeneous data and assumptions for all health states. The utility values ranged from 0.68 to 0.97 for risk-reducing surgeries, 0.6 to 0.85 for BC and 0.5 to 0.82 for OC. In two out of nine studies, considering the impact of the test result strongly affected the cost-effectiveness ratio. While in general utilities seem not to affect the cost-utility ratio, in future modeling studies the impact of a positive/negative test on utility should be considered mandatory. Women's health preferences, which may have changed as a result of improved oncologic care and genetic counselling, should be re-evaluated.

[Prospects for the implementation of the Innovation Fund project GeMuKi - a cross sectional study on attitudes of health care providers regarding preventive lifestyle counselling in routine prenatal visits and infant check-ups]. / Perspektiven für die Implementierung des Innovationsfondsprojekt GeMuKi: Eine Querschnittserhebung der Einstellungen von Leistungserbringern zu einer präventiven Lebensstilberatung in den Schwangerschafts- und Kindervorsorgeuntersuchungen.

INTRODUCTION: Overweight and obesity are major public health concerns in Germany. As patients can easily be accessed via physicians' offices, this setting provides a high potential for prevention. However, the limited implementation of prevention and health promotion interventions in physicians' offices so far indicates that barriers to implementation exist. This study therefore addresses how obesity prevention interventions should be designed and implemented so that health care providers perceive them as appropriate and are willing to adopt them in their daily practice. The study is performed by taking the Innovation Fund project "GeMuKi" as an example. METHODS: A mixed-methods study was conducted. Data collection took place within the context of the GeMuKi training session that health care providers complete in preparation for implementing the intervention. Gynecologists, pediatricians, midwives, and medical assistants completed a questionnaire. The questions covered the implementation outcomes "appropriateness" and "adoption". Text entry fields were used to obtain information on feasibility as well as anticipated facilitating and hindering factors. In addition, observation protocols were prepared for each training session by the project team. The questionnaire was analyzed descriptively. Text entry fields and protocols were evaluated using qualitative content analysis. RESULTS: Four hundred and one (n=401) training participants completed the questionnaire. Almost three quarters (73 %) of the health care providers indicate that they are motivated to implement the intervention. At the same time, concerns are expressed about organizational feasibility in everyday practice. Nevertheless, 72 % expect their care to improve as a result of the project. CONCLUSION: The health care providers surveyed are positive about the implementation of the project in everyday practice. By documenting concerns about the implementation, the barriers identified can be addressed during the project course.

Health literacy among pregnant women in a lifestyle intervention trial: protocol for an explorative study on the role of health literacy in the perinatal health service setting.

INTRODUCTION: Pregnancy is a vulnerable period that affects long-term health of pregnant women and their unborn infants. Health literacy plays a crucial role in promoting healthy behaviour and thereby maintaining good health. This study explores the role of health literacy in the GeMuKi (acronym for 'Gemeinsam Gesund: Vorsorge plus für Mutter und Kind'-Strengthening health promotion: enhanced check-up visits for mother and child) Project. It will assess the ability of the GeMuKi lifestyle intervention to positively affect health literacy levels through active participation in preventive counselling. The study also explores associations between health literacy, health outcomes, health service use and effectiveness of the intervention. METHODS AND ANALYSIS: The GeMuKi trial has a hybrid effectiveness-implementation design and is carried out in routine prenatal health service settings in Germany. Women (n=1860) are recruited by their gynaecologist during routine check-up visits before 12 weeks of gestation. Trained healthcare providers carry out counselling using motivational interviewing techniques to positively affect health literacy and lifestyle-related risk factors. Healthcare providers (gynaecologists and midwives) and women jointly agree on Specific, Measurable, Achievable Reasonable, Time-Bound goals. Women will be invited to fill in questionnaires at two time points (at recruitment and 37th-40th week of gestation) using an app. Health literacy is measured using the German version of the Health Literacy Survey-16 and the Brief Health Literacy Screener. Lifestyle is measured with questions on physical activity, nutrition, alcohol and drug use. Health outcomes of both mother and child, including gestational weight gain (GWG) will be documented at each routine visit. Health service use will be assessed using social health insurance claims data. Data analyses will be conducted using IBM SPSS Statistics, version 26.0. These include descriptive statistics, tests and regression models. A mediation model will be conducted to answer the question whether health behaviour mediates the association between health literacy and GWG. ETHICS AND DISSEMINATION: The study was approved by the University Hospital of Cologne Research Ethics Committee (ID: 18-163) and the State Chamber of Physicians in Baden-Wuerttemberg (ID: B-F-2018-100). Study results will be disseminated through (poster) presentations at conferences, publications in peer-reviewed journals and press releases. TRAIL REGISTRATION: German Clinical Trials Register (DRKS00013173). Registered pre-results, 3rd of January 2019, https://www.drks.de.

Resource dependency and strategy in healthcare organizations during a time of scarce resources: evidence from the metropolitan area of cologne.

PURPOSE: Healthcare systems are under pressure to improve their performance, while at the same time facing severe resource constraints, particularly workforce shortages. By applying resource-dependency-theory (RDT), we explore how healthcare organizations in different settings perceive pressure arising from uncertain access to resources and examine organizational strategies they deploy to secure resources. DESIGN/METHODOLOGY/APPROACH: A cross-sectional survey of key decision-makers in different healthcare settings in the metropolitan area of Cologne, Germany, on perceptions of pressure arising from the environment and respective strategies was conducted. For comparisons between settings radar charts, Kruskal-Wallis test and Fisher-Yates test were applied. Additionally, correlation analyses were conducted. FINDINGS: A sample of n = 237(13%) key informants participated and reported high pressure caused by bureaucracy, time constraints and recruiting qualified staff. Hospitals, inpatient and outpatient nursing care organizations felt most pressurized. As suggested by RDT, organizations in highly pressurized settings deployed the most vociferous strategies to secure resources, particularly in relation to personnel development. ORIGINALITY/VALUE: This study is one of the few studies that focuses on the environment's impact on healthcare organizations across a variety of settings. RDT is a helpful theoretical foundation for understanding the environment's impact on organizational strategies. The substantial variations found between healthcare settings indicate that those settings potentially require specific strategies when seeking to address scarce resources and high demands. The results draw attention to the high level of pressure on healthcare organizations which presumably is passed down to managers, healthcare professionals, patients and relatives.

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.

The development and validation of a resource consumption score of an emergency department consultation.

BACKGROUND: Emergency Department (ED) visits and health care costs are increasing globally, but little is known about contributing factors of ED resource consumption. This study aims to analyse and to predict the total ED resource consumption out of the patient and consultation characteristics in order to execute performance analysis and evaluate quality improvements. METHODS: Characteristics of ED visits of a large Swiss university hospital were summarized according to acute patient condition factors (e.g. chief complaint, resuscitation bay use, vital parameter deviations), chronic patient conditions (e.g. age, comorbidities, drug intake), and contextual factors (e.g. night-time admission). Univariable and multivariable linear regression analyses were conducted with the total ED resource consumption as the dependent variable. RESULTS: In total, 164,729 visits were included in the analysis. Physician resources accounted for the largest proportion (54.8%), followed by radiology (19.2%), and laboratory work-up (16.2%). In the multivariable final model, chief complaint had the highest impact on the total ED resource consumption, followed by resuscitation bay use and admission by ambulance. The impact of age group was small. The multivariable final model was validated (R2 of 0.54) and a scoring system was derived out of the predictors. CONCLUSIONS: More than half of the variation in total ED resource consumption can be predicted by our suggested model in the internal validation, but further studies are needed for external validation. The score developed can be used to calculate benchmarks of an ED and provides leaders in emergency care with a tool that allows them to evaluate resource decisions and to estimate effects of organizational changes.

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.