Economic Evaluation of a Mobile Stroke Unit Service in Germany.

BACKGROUND: Lower global disability and higher quality of life among ischemic stroke patients was found to be associated with the dispatch of mobile stroke units (MSUs) among patients eligible for recanalizing treatments in the Berlin_Prehospital Or Usual Delivery of stroke care (B_PROUD) study. The current study assessed the cost-utility and cost-effectiveness of additional MSU dispatch using data from this prospective, controlled, intervention study. METHODS: Outcomes considered in the economic evaluation included quality-adjusted life years (QALYs) derived from the 3-level version of EQ-5D (EQ-5D-3L) and modified Rankin Scale (mRS) scores for functional outcomes 3-months after stroke. Costs were prospectively collected during the study by the MSU provider (Berlin Fire Brigade) and the B_PROUD research team. We focus our results on the societal perspective. As we aimed to determine the economic consequences of the intervention beyond the study's follow-up period, both care costs and QALYs were extrapolated over 5 years. RESULTS: The additional MSU dispatch resulted in an incremental €40,984 per QALY. The best-case scenario and the worst-case scenario yielded additional costs of, respectively, €24,470.76 and €61,690.88 per QALY. In the cost-effectiveness analysis, MSU dispatch resulted in incremental costs of €81,491 per survival without disability. The best-case scenario and the worst-case scenario yielded additional costs of, respectively, €44,455.30 and €116,491.15 per survival without disability. INTERPRETATION: Among patients eligible for recanalizing treatments in ischemic stroke, MSU dispatch was associated with both higher QALYs and higher costs and is cost-effective when considering internationally accepted thresholds ranging from an additional €40,000 to €80,000 per QALY. ANN NEUROL 2023;93:942-951.

Patient-Reported Outcome Measures as an Intervention: A Comprehensive Overview of Systematic Reviews on the Effects of Feedback.

OBJECTIVES: Patient-reported outcome measures (PROMs) have emerged as a promising approach to involve patients in their treatment process. Beyond serving as outcome measures, PROMs can be applied to provide feedback to healthcare providers and patients, thereby offering valuable insights that can improve health outcomes and care processes. This overview offers a comprehensive synthesis of the effects of PROM feedback, contributing to the evidence-based discussion on PROMs' potential to enhance patient care. METHODS: Following Cochrane Collaboration recommendations, this overview included literature reviews across diverse treatment areas, investigating the impact of PROM feedback on patient health outcomes (including quality of life, symptoms, or survival) and care process outcomes (including communication, symptom identification, or clinical practice). The methodological quality of the evidence was assessed with a modified version of A Measurement Tool to Assess Systematic Reviews 2, and the potential overlap of primary studies was quantified. Results were narratively synthesized. RESULTS: Forty reviews grouped into 4 categories of treatment areas were included. Overall, their methodological quality was low. The overall overlap of primary studies was 2.2%, reaching up to 15.7% within specific treatment areas. The results indicate that PROM feedback may enhance the quality-of-care processes, whereas its effects on patient health outcomes remained less conclusive. CONCLUSIONS: PROM feedback positively influences the interaction between physicians and patients across the included treatment areas. Further research is needed to comprehend the trickle-down effects of PROM feedback and how to enhance its potential in yielding health benefits for patients.

Gender health gap pre- and post-joint arthroplasty: identifying affected patient-reported health domains.

BACKGROUND: As patient-reported outcomes (PROs) gain prominence in hip and knee arthroplasty (HA and KA), studies indicate PRO variations between genders. Research on the specific health domains particularly impacted is lacking. Hence, we aim to quantify the gender health gap in PROs for HA/KA patients, differentiating between general health, health-related quality of life (HrQoL), physical functioning, pain, fatigue, and depression. METHODS: The study included 3,693 HA patients (1,627 men, 2,066 women) and 3,110 KA patients (1,430 men, 1,680 women) receiving surgery between 2020 to 2021 in nine German hospitals, followed up until March 2022. Questionnaires used were: EQ-VAS, EQ-5D-5L, HOOS-PS, KOOS-PS, PROMIS-F-SF, PROMIS-D-SF, and a joint-specific numeric pain scale. PROs at admission, discharge, 12-months post-surgery, and the change from admission to 12-months (PRO-improvement) were compared by gender, tested for differences, and assessed using multivariate linear regressions. To enable comparability, PROs were transformed into z-scores (standard deviations from the mean). RESULTS: Observed differences between genders were small in all health domains and differences reduced over time. Men reported significantly better health versus women pre-HA (KA), with a difference of 0.252 (0.224) standard deviations from the mean for pain, 0.353 (0.243) for fatigue (PROMIS-F-SF), 0.327 (0.310) for depression (PROMIS-D-SF), 0.336 (0.273) for functionality (H/KOOS-PS), 0.177 (0.186) for general health (EQ-VAS) and 0.266 (0.196) for HrQoL (EQ-5D-5L). At discharge, the gender health gap reduced and even disappeared for some health dimensions since women improved in health to a greater extent than men. No gender health gap was observed in most PRO-improvements and at month 12. CONCLUSIONS: Men experiencing slightly better health than women in all health dimensions before surgery while experiencing similar health benefits 12-months post-surgery, might be an indicator of men receiving surgery inappropriately early, women unnecessarily late or both. As studies often investigate the PRO-improvement, they miss pre-surgery gender differences, which could be an important target for improvement initiatives in patient-centric care. Moreover, future research on cutoffs for meaningful between-group PRO differences per measurement time would aid the interpretation of gender health disparities. TRIAL REGISTRATION: German Register for Clinical Trials, DRKS00019916, 26 November 2019.

Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care - Protocol for a health economic evaluation alongside a randomized controlled trial.

BACKGROUND: Prehabilitation aims to improve patients' functional capacity before surgery to reduce perioperative complications, promote recovery and decrease probability of disability. The planned economic evaluation is performed alongside a large German multi-centre pragmatic, two-arm parallel-group, randomized controlled trial on prehabilitation for frail elderly patients before elective surgery compared to standard care (PRAEP-GO RCT). The aim is to determine the cost-effectiveness and cost-utility of prehabilitation for frail elderly before an elective surgery. METHODS: The planned health economic evaluation comprises cost-effectiveness, and cost-utility analyses. Analyses are conducted in the German context from different perspectives including the payer perspective, i.e. the statutory health insurance, the societal perspective and the health care provider perspective. Data on outcomes and costs, are collected alongside the ongoing PRAEP-GO RCT. The trial population includes frail or pre-frail patients aged ≥70 years with planned elective surgery. The intervention consists of frailty screening (Fried phenotype), a shared decision-making conference determining modality (physiotherapy and unsupervised physical exercises, nutrition counselling, etc.) and setting (inpatient, day care, outpatient etc.) of a 3-week individual multimodal prehabilitation prior to surgery. The control group receives standard preoperative care. Costs include the intervention costs, the costs of the index hospital stay for surgery, and health care resources consumed during a 12-month follow-up. Clinical effectiveness outcomes included in the economic evaluation are the level of care dependency, the degree of disability as measured by the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), quality-adjusted life years (QALY) derived from the EQ-5D-5L and the German utility set, and complications occurring during the index hospital stay. Each adopted perspective considers different types of costs and outcomes as outlined in the protocol. All analyses will feature Intention-To-Treat analysis. To explore methodological and parametric uncertainties, we will conduct probabilistic and deterministic sensitivity analyses. Subgroup analyses will be performed as secondary analyses. DISCUSSION: The health economic evaluation will provide insights into the cost-effectiveness of prehabilitation in older frail populations, informing decision-making processes and contributing to the evidence base in this field. Potential limitation includes a highly heterogeneous trial population. TRIAL REGISTRATION: PRAEP-GO RCT: NCT04418271; economic evaluation: OSF ( https://osf.io/ecm74 ).

Impact of early death recording on international comparison of acute myocardial infarction mortality - administrative hospital data study using the example of Germany and the United States.

BACKGROUND: In-hospital mortality from acute myocardial infarction (AMI) is widely used in international comparisons as an indicator of health system performance. Because of the high risk of early death after AMI, international comparisons may be biased by differences in the recording of early death cases in hospital inpatient data. This study examined whether differences in the recording of early deaths affect international comparisons of AMI in-hospital mortality by using the example of Germany and the United States, and explored approaches to address this issue. METHODS: The German Diagnosis-Related Groups Statistics (DRG Statistics), the U.S. National Inpatient Sample (NIS) and the U.S. Nationwide Emergency Department Sample (NEDS) were analysed from 2014 to 2019. Cases with treatment for AMI were identified in German and U.S. inpatient data. AMI deaths occurring in the emergency department (ED) without inpatient admission were extracted from NEDS data. 30-day in-hospital mortality figures were calculated according to the OECD indicator definition (unlinked data) and modified by including ED deaths, or excluding all same-day cases. RESULTS: German age-and-sex standardized 30-day in-hospital mortality was substantially higher compared to the U.S. (in 2019, 7.3% vs. 4.6%). The ratio of German vs. U.S. mortality was 1.6. After inclusion of ED deaths in U.S. data this ratio declined to 1.4. Exclusion of same-day cases in German and U.S. data led to a similar ratio. CONCLUSIONS: While short-duration treatments due to early death are generally recorded in German inpatient data, in U.S. inpatient data those cases are partially missing. Excluding cases with short-duration treatment from the calculation of mortality indicators could be a feasible approach to account for differences in the recording of early deaths, that might be existent in other countries as well.

Who Benefits From Hip Arthroplasty or Knee Arthroplasty? Preoperative Patient-reported Outcome Thresholds Predict Meaningful Improvement.

BACKGROUND: Hip arthroplasty (HA) and knee arthroplasty (KA) are high-volume procedures. However, there is a debate about the quality of indication; that is, whether surgery is truly indicated in all patients. Patient-reported outcome measures (PROMs) may be used to determine preoperative thresholds to differentiate patients who will likely benefit from surgery from those who will not. QUESTIONS/PURPOSES: (1) What were the minimum clinically important differences (MCIDs) for three commonly used PROMs in a large population of patients undergoing HA or KA treated in a general orthopaedic practice? (2) Do patients who reach the MCID differ in important ways from those who do not? (3) What preoperative PROM score thresholds best distinguish patients who achieve a meaningful improvement 12 months postsurgery from those who do not? (4) Do patients with preoperative PROM scores below thresholds still experience gains after surgery? METHODS: Between October 1, 2019, and December 31, 2020, 4182 patients undergoing HA and 3645 patients undergoing KA agreed to be part of the PROMoting Quality study and were hence included by study nurses in one of nine participating German hospitals. From a selected group of 1843 patients with HA and 1546 with KA, we derived MCIDs using the anchor-based change difference method to determine meaningful improvements. Second, we estimated which preoperative PROM score thresholds best distinguish patients who achieve an MCID from those who do not, using the preoperative PROM scores that maximized the Youden index. PROMs were Hip Disability and Osteoarthritis Outcome Score-Physical Function short form (HOOS-PS) (scored 0 to 100 points; lower indicates better health), Knee Injury and Osteoarthritis Outcome Score-Physical Function short form (KOOS-PS) (scored 0 to 100 points; lower indicates better health), EuroQol 5-Dimension 5-level (EQ-5D-5L) (scored -0.661 to 1 points; higher indicates better health), and a 10-point VAS for pain (perceived pain in the joint under consideration for surgery within the past 7 days) (scored 0 to 10 points; lower indicates better health). The performance of derived thresholds is reported using the Youden index, sensitivity, specificity, F1 score, geometric mean as a measure of central tendency, and area under the receiver operating characteristic curve. RESULTS: MCIDs for the EQ-5D-5L were 0.2 for HA and 0.2 for KA, with a maximum of 1 point, where higher values represented better health-related quality of life. For the pain scale, they were -0.9 for HA and -0.7 for KA, of 10 points (maximum), where lower scores represent lower pain. For the HOOS-PS, the MCID was -10, and for the KOOS-PS it was -5 of 100 points, where lower scores represent better functioning. Patients who reached the MCID differed from patients who did not reach the MCID with respect to baseline PROM scores across the evaluated PROMs and for both HA and KA. Patients who reached an MCID versus those who did not also differed regarding other aspects including education and comorbidities, but this was not consistent across PROMs and arthroplasty type. Preoperative PROM score thresholds for HA were 0.7 for EQ-5D-5L (Youden index: 0.55), 42 for HOOS-PS (Youden index: 0.27), and 3.5 for the pain scale (Youden index: 0.47). For KA, the thresholds were 0.6 for EQ-5D-5L (Youden index: 0.57), 39 for KOOS-PS (Youden index: 0.25), and 6.5 for the pain scale (Youden index: 0.40). A higher Youden index for EQ-5D-5L than for the other PROMs indicates that the thresholds for EQ-5D-5L were better for distinguishing patients who reached a meaningful improvement from those who did not. Patients who did not reach the thresholds could still achieve MCIDs, especially for functionality and the pain scale. CONCLUSION: We found that patients who experienced meaningful improvements (MCIDs) mainly differed from those who did not regarding their preoperative PROM scores. We further identified that patients undergoing HA or KA with a score above 0.7 or 0.6, respectively, on the EQ-5D-5L, below 42 or 39 on the HOOS-PS or KOOS-PS, or below 3.5 or 6.5 on a 10-point joint-specific pain scale presurgery had no meaningful benefit from surgery. The thresholds can support clinical decision-making. For example, when thresholds indicate that a meaningful improvement is not likely to be achieved after surgery, other treatment options may be prioritized. Although the thresholds can be used as support, patient preferences and medical expertise must supplement the decision. Future studies might evaluate the utility of using these thresholds in practice, examine how different thresholds can be combined as a multidimensional decision tool, and derive presurgery thresholds based on additional PROMs used in practice. CLINICAL RELEVANCE: Preoperative PROM score thresholds in this study will support clinicians in decision-making through objective measures that can improve the quality of the recommendation for surgery.

The role of consumer choice in out-of-pocket spending on health.

BACKGROUND: Analyses of out-of-pocket healthcare spending often suffer from an inability to distinguish necessary from optional spending in the data without making further assumptions. We propose a two-dimensional rating of the spending categories often available in household budget survey data where we consider the requirement to pay for necessary healthcare as one dimension and the incentive to pay extra for additional services, higher quality options or more convenience as a second dimension to assess the distortionary potential of higher spending for additional healthcare or higher quality options. METHODS: We use three waves of a large German Household Budget Survey and decompose the Kakwani-index of total out-of-pocket healthcare spending into contributions of the eleven spending categories available in our data, across which user charge regulations vary considerably. We compute and decompose Kakwani-indexes for the different spending categories to compare the degrees of regressiveness across them. RESULTS: The results suggest that categories with higher incentives for additional spending exhibit smaller contributions to the overall regressive effect of total out-of-pocket spending than categories where spending is presumably mostly on necessary and effective care. CONCLUSIONS: Assessing the consumer choice potential of different spending categories is important because extra spending among the better-off may outweigh necessary spending in aggregate expenditure data, and may also hint at potential inequalities in the quality of provided healthcare.

A composite measure for patient-reported outcomes in orthopedic care: design principles and validity checks.

BACKGROUND: The complex, multidimensional nature of healthcare quality makes provider and treatment decisions based on quality difficult. Patient-reported outcome (PRO) measures can enhance patient centricity and involvement. The proliferation of PRO measures, however, requires a simplification to improve comprehensibility. Composite measures can simplify complex data without sacrificing the underlying information. OBJECTIVE AND METHODS: We propose a five-step development approach to combine different PRO into one composite measure (PRO-CM): (i) theoretical framework and metric selection, (ii) initial data analysis, (iii) rescaling, (iv) weighting and aggregation, and (v) sensitivity and uncertainty analysis. We evaluate different rescaling, weighting, and aggregation methods by utilizing data of 3145 hip and 2605 knee replacement patients, to identify the most advantageous development approach for a PRO-CM that reflects quality variations from a patient perspective. RESULTS: The comparison of different methods within steps (iii) and (iv) reveals the following methods as most advantageous: (iii) rescaling via z-score standardization and (iv) applying differential weights and additive aggregation. The resulting PRO-CM is most sensitive to variations in physical health. Changing weighting schemes impacts the PRO-CM most directly, while it proves more robust towards different rescaling and aggregation approaches. CONCLUSION: Combining multiple PRO provides a holistic picture of patients' health improvement. The PRO-CM can enhance patient understanding and simplify reporting and monitoring of PRO. However, the development methodology of a PRO-CM needs to be justified and transparent to ensure that it is comprehensible and replicable. This is essential to address the well-known problems associated with composites, such as misinterpretation and lack of trust.

Applying a data-driven population segmentation approach in German claims data.

BACKGROUND: Segmenting the population into homogenous groups according to their healthcare needs may help to understand the population's demand for healthcare services and thus support health systems to properly allocate healthcare resources and plan interventions. It may also help to reduce the fragmented provision of healthcare services. The aim of this study was to apply a data-driven utilisation-based cluster analysis to segment a defined population in the south of Germany. METHODS: Based on claims data of one big German health insurance a two-stage clustering approach was applied to group the population into segments. A hierarchical method (Ward's linkage) was performed to determine the optimal number of clusters, followed by a k-means cluster analysis using age and healthcare utilisation data in 2019. The resulting segments were described in terms of their morbidity, costs and demographic characteristics. RESULTS: The 126,046 patients were divided into six distinct population segments. Healthcare utilisation, morbidity and demographic characteristics differed significantly across the segments. The segment "High overall care use" comprised the smallest share of patients (2.03%) but accounted for 24.04% of total cost. The overall utilisation of services was higher than the population average. In contrast, the segment "Low overall care use" included 42.89% of the study population, accounting for 9.94% of total cost. Utilisation of services by patients in this segment was lower than population average. CONCLUSION: Population segmentation offers the opportunity to identify patient groups with similar healthcare utilisation patterns, patient demographics and morbidity. Thereby, healthcare services could be tailored for groups of patients with similar healthcare needs.

Utilization of innovative medical technologies in German inpatient care: does evidence matter?

BACKGROUND: The reimbursement of new technologies in inpatient care is not always linked to a requirement for evidence-based evaluation of patient benefit. In Germany, every new technology approved for market was until recently eligible for reimbursement in inpatient care unless explicitly excluded. The aim of this work was (1) to investigate the type of evidence that was available at the time of introduction of 25 innovative technologies and how this evidence evolved over time, and (2) to explore the relationship between clinical evidence and utilization for these technologies in German inpatient care. METHODS: This study combined different methods. A systematic search for evidence published between 2003 and 2017 was conducted in four bibliographic databases, clinical trial registries, resources for clinical guidelines, and health technology assessment-databases. Information was also collected on funding mechanisms and safety notices. Utilization was measured by hospital procedures captured in claims data. The body of evidence, funding and safety notices per technology were analyzed descriptively. The relationship between utilization and evidence was explored empirically using a multilevel regression analysis. RESULTS: The number of included publications per technology ranges from two to 498. For all technologies, non-comparative studies form the bulk of the evidence. The number of randomized controlled clinical trials per technology ranges from zero to 19. Some technologies were utilized for several years without an adequate evidence base. A relationship between evidence and utilization could be shown for several but not all technologies. CONCLUSIONS: This study reveals a mixed picture regarding the evidence available for new technologies, and the relationship between the development of evidence and the use of technologies over time. Although the influence of funding and safety notices requires further investigation, these results re-emphasize the need for strengthening market approval standards and HTA pathways as well as approaches such as coverage with evidence development.

[Recording Trauma Care in German Hospital Discharge Data: Services Provided by Hospitals Owned by Workers' Compensation Funds and Financed through Statutory Accidental Insurance]. / Erfassung der Verletztenversorgung in Krankenhausabrechnungsdaten: Leistungen der BG Kliniken zu Lasten der Gesetzlichen Unfallversicherung.

BACKGROUND: In Germany, the Diagnosis-Related Group Statistics (DRG Statistics) represent an almost complete discharge data-based registry of inpatient services in acute care hospitals. However, services of hospitals owned by workers' compensation funds and financed through the statutory insurance for occupational accidents are excluded from the obligation of submitting hospital discharge data. Hence, the DRG statistics might be incomplete regarding inpatient services for trauma care. METHODS: In order to illustrate trauma and post-trauma care in acute care hospitals, groups of specific inpatient services were defined. Numbers of cases according to these groups were identified in the microdata of the DRG statistics, as well as in the inpatient data of all nine workers' compensation funds hospitals in Germany. By dividing cases financed through the statutory insurance for occupational accidents from cases financed through other payers, the overlap of both databases as well as the share of cases not recorded in the DRG statistics were quantified. The analysis comprised data of 2016-2018. RESULTS: Depending on the type of service, the share of cases not recorded in the DRG statistics varied between 0.1% and more than 60% (accumulated 2016 to 2018). There was under-recording of early-stage rehabilitation for traumatic brain injury (61%), treatment for traumatic paraplegia (14% for initial treatment and 23% for subsequent treatment), treatment for amputation injury (13%) and treatment for severe hand injury (5%). CONCLUSION: Regarding inpatient services that are not covered by the statutory insurance for occupational accidents, the microdata of the DRG statistics can be considered as virtually complete. However, inpatient services for trauma care are not completely recorded because discharge data are not submitted by hospitals run by workers' compensation funds when services are financed through the statutory insurance for occupational accidents. Analyses of trauma care can only be complete if data of hospitals financed by workers' compensation funds are included.

[Specialised treatment of colorectal cancer in certified cancer centres: Do patients really have to travel further?] / Spezialisierte Behandlung von Darmkrebs in zertifizierten Krebszentren: Müssen Patient*innen wirklich weitere Wege auf sich nehmen?

INTRODUCTION: In Germany, many cancer patients are treated outside of cancer centres certified by the German Cancer Society (DKG) resulting in underuse of these facilities and inferior oncological treatment. One way to address this issue would be to restructure the healthcare landscape by following the Danish approach that limits cancer treatment to specialized hospitals. Such an approach would have an impact on the travelling times to treatment centers. The present study determines the impact on patient travel times using the example of colorectal cancer. METHODS: For the present analysis, data from structured quality reports (sQB) and from patients insured with the AOK who underwent resection of the colon or rectum during 2018 were used. In addition, data from the DKG regarding an existing certification of a colorectal cance centre were used. Travel time was defined as the time patients spent in an average car with average traffic from the midpoint of the ZIP code of their residence to the coordinates of the hospital. The coordinates of the hospitals and the midpoints of the ZIP codes were obtained by querying the Google API. Travel times were calculated with a local Open Routing Machine server. The statistical programs R and Stata were used for analyses and cartographic representations. RESULTS: In 2018, nearly half of all patients with colon cancer were treated at the hospital nearest to their place of residence, of whom approximately 40% were treated at a certified colorectal cancer centre. Overall, only about 47% of all treatments took place at a certified colorectal cancer centre. Travel time to the chosen treatment site averaged 20 minutes. It was minimally shorter (18 minutes) if no certified centre was chosen and minimally longer (21 minutes) for those whose treatment took place in a certified colorectal cancer centre. Modeling of redistributions of all patients to certified centres resulted on an average travel time of 29 minutes. CONCLUSION: Even if treatment were limited to specialized hospitals, treatment close to home would still be guaranteed. Regardless of certification, parallel structures can be identified, especially in metropolitan areas, which indicate a potential for restructuring.

[Slow demographic change and neurological rehabilitation-Part 2: what we can do]. / Schleichender demografischer Wandel und neurologische Rehabilitation ­ Teil 2: Handlungsmöglichkeiten.

In its current state the German healthcare system will not be able to adequately care for a growing proportion of older patients with a decreasing healthcare work force. This is particularly so in the postacute care of severely ill patients. In a second of two parts we discuss the perspectives and options at hand. A major conclusion is that substantial gains could be obtained by regulatory adjustments that better align acute care and rehabilitative measures.

[Slow demographic change and neurological rehabilitation-Part 1: state of affairs]. / Schleichender demografischer Wandel und neurologische Rehabilitation ­ Teil 1: Situationsbeschreibung.

In the next two decades the aging baby boomers in Germany will gradually be leaving the work force. They are being followed by the much less numerous, "baby bust" generation who now need to finance and staff healthcare for the growing number of old people in society. In order to care for more needy persons with a smaller working population, the healthcare system must be restructured; however, despite these worrisome prospects, the awareness of the problem is still low in many areas. Here we focus on the area in the healthcare system that is growing particularly rapidly and additionally has the greatest need of personnel per patient: the care of the critically ill and functionally impaired patients. The lack of coordination of hospitals, rehabilitation centers and nursing institution is historical in origin. It promotes the tendency to discharge functionally impaired patients to nursing facilities without giving them a chance for recovery of functional autonomy. As the demographic change progresses, this tendency threatens to increase. In a first of two parts, we attempt to describe the present situation.

Toward System-Wide Implementation of Patient-Reported Outcome Measures: A Framework for Countries, States, and Regions.

OBJECTIVES: This study aimed to develop a framework facilitating (1) the maturity assessment of healthcare systems regarding patient-reported outcome measure (PROM) implementation and (2) the comparison of different healthcare systems' PROM implementation levels to guide discussions and derive lessons for regional, state-level, and national PROM initiatives. METHODS: Guided by the grounded theory methodology, a PROM healthcare system implementation framework was developed following multiple steps. Based on interviews with 28 experts from 12 countries and a literature review, a framework was drafted and refined through 29 additional validation interviews. RESULTS: The resulting framework comprises 5 implementation stages along 7 dimensions. Implementation stages range from "first experimentation" to "system-wide adoption and a vibrant ecosystem." The dimensions are grouped into patient-reported outcome (PRO) measurement and PRO utilization, the former with the dimensions "scope and condition coverage," "metric and process standardization," and "tools and information technology-based solutions" and the latter with "patient empowerment and clinical decision support," "reporting and quality improvement," and "rewarding and contracting." The "culture and stakeholder involvement" dimension connects both groups. Although a concerted implementation approach across dimensions can be observed in advanced countries, others show a more uneven adoption. CONCLUSIONS: The framework and its preliminary application to different healthcare systems demonstrate (1) the importance of coherent progress across complementing dimensions and (2) the relevance of PROM integration across clinical specialties and care sectors to strengthen patient-centered care. Overall, the framework can facilitate dialogues between stakeholders to analyze the current PROM implementation status and strategies to advance it.

Health care patterns and policies in 18 European countries during the first wave of the COVID-19 pandemic: an observational study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has developed into an unprecedented global challenge. Differences between countries in testing strategies, hospitalization protocols as well as ensuring and managing ICU capacities can illustrate initial responses to a major health system shock, and steer future preparedness activities. METHODS: Publicly available daily data for 18 European countries were retrieved manually from official sources and documented in an Excel table (March-July 2020). The ratio of tests to cases, the share of hospitalizations out of all cases and the share of ICU admissions out of all hospitalizations were computed using 7-day rolling averages per 100 000 population. Information on country policies was collected from the COVID-19 Health System Response Monitor of the European Observatory on Health Systems and Policies. Information on health care capacities, expenditure and utilization was extracted from the Eurostat health database. RESULTS: There was substantial variation across countries for all studied variables. In all countries, the ratio of tests to cases increased over time, albeit to varying degrees, while the shares of hospitalizations and ICU admissions stabilized, reflecting the evolution of testing strategies and the adaptation of COVID-19 health care delivery pathways, respectively. Health care patterns for COVID-19 at the outset of the pandemic did not necessarily follow the usual health service delivery pattern of each health system. CONCLUSIONS: This study enables a general understanding of how the early evolution of the pandemic influenced and was influenced by country responses and clearly demonstrates the immense potential for cross-country learning.

Reimbursement decisions for medical services in Austria: an analysis of influencing factors for the hospital individual services catalogue between 2008 and 2020.

OBJECTIVES: To (1) describe the (evidence-based) reimbursement process of hospital individual services, (2) evaluate the accordance between evidence-based recommendations and reimbursement decision of individual services and (3) elaborate potential aspects that play a role in the decision-making process in Austria. METHOD: The reimbursement process is described based on selected relevant sources such as official documents. Evidence-based recommendations and subsequent reimbursement decisions for the annual maintenance of the hospital individual service catalogue in Austria between 2008 and 2020 were analysed using a mixed methods approach, encompassing descriptive statistics and a focus group with Austrian decision makers. RESULTS: 118 evidence-based recommendations were analysed. There were 93 (78.8%) negative and 25 (21.2%) positive evidence-based recommendations. In total, 107 out of 118 evidence-based recommendations (90.1%) did not lead to a deviating reimbursement decision. We identified six aspects that may have played a role in the decision-making process for the annual maintenance of the hospital individual service catalogue, with clinical evidence being the most notable. Further aspects included quality assurance/organisational aspects (i.e., structural quality assurance), costs (if comparable to already existing medical services, not: cost-effectiveness), procedural aspects (e.g., if certain criteria for adoption have not been met formally through the proposals), "other countries" (i.e., taking into account how other countries decided) and situational aspects (such as the COVID-19 pandemic). CONCLUSIONS: There is good accordance between evidence-based recommendations and reimbursement decisions regarding hospital individual services in Austria. Beyond clinical evidence, organisational aspects seem to be considered often with regard to quality assurance but costs do not appear to play a major role. The Austrian system has mechanisms in place that can restrict widespread adoption of novel hospital individual services with uncertain clinical benefits. Future studies could investigate how well these mechanisms work and how they compare to other health systems in Europe.

Digital health applications and the fast-track pathway to public health coverage in Germany: challenges and opportunities based on first results.

OBJECTIVES: Evidence-based decision-making is the sine qua non for safe and effective patient care and the long-term functioning of health systems. Since 2020 Digital Health Applications (DiHA) in Germany have been undergoing a systematic pathway to be reimbursed by statutory health insurance (SHI) which is attracting attention in other European countries. We therefore investigate coverage decisions on DiHA and the underlying evidence on health care effects, which legally include both medical outcomes and patient-centred structural and procedural outcomes. METHODS: Based on publicly available data of the Institute for Medicines and Medical Devices searched between 08/2021 and 02/2022, all DiHA listed in the corresponding registry and thus reimbursable by the SHI were systematically investigated and presented descriptively on the basis of predefined criteria, such as clinical condition, and costs. The clinical trials on DiHA permanently included in the registry were reviewed with regard to their study design, endpoints investigated, the survey instruments used, and whether an intention-to-treat analysis was performed. Risk of bias was assessed using the ROB II tool. RESULTS: By February 2022, 30 DiHA had been included in the DiHA registry, one third of them permanently and two thirds conditionally. Most DiHA were therapeutic applications for mental illness based on cognitive behavioural therapy. For all permanently included DiHA, randomised controlled trials were conducted to demonstrate the impact on health care effects. While medical outcomes were investigated for all of these DiHA, patient-centred structural and procedural outcomes were rarely investigated. The majority of clinical trials showed a high risk of bias, mainly due to insufficient reporting quality. Overall, the prices for DiHA covered by SHI are on average around € 150 per month (min. € 40; max. € 248). CONCLUSIONS: Evidence-based decision-making on coverage of DiHA leaves room for improvements both in terms of reporting-quality and the use of patient-centred structural and procedural outcomes in addition to medical outcomes. With appropriate evidence, DiHA can offer an opportunity as an adjunct to existing therapy while currently the high risk of bias of the trials raises doubts about the justification of its high costs.

Drivers of patient perceptions of health system responsiveness in Germany.

BACKGROUND: Health system responsiveness (HSR)-the ability of a health system to meet the non-medical legitimate expectations of patients-is a key to patient-centred health systems. Although responsiveness is essential to provide equitable and accountable health care, little is known about patient-side drivers of HSR. This study aims to narrow this gap. METHODS: A survey among 20,000 Germans with substitutive private health insurance included questions on HSR and patient characteristics such as health literacy (HL), experienced discrimination, and sociodemographic information. Survey data were linked to patient-level claims data. Logistic regression was applied to assess the association between HSR and patient characteristics. RESULTS: The sample (age 54.0 ± 16.1; 60.5% male) contains 2951 respondents with outpatient physician care in the past year. Of the nine HSR items, eight are rated as (very) good (74.4%-94.3%), except for coordination between providers (60.2%). Patient characteristics highly influence HSR: patients with high HL, for instance, are more likely to assess responsiveness as (very) good (e.g., clear explanations from physicians: OR 4.17). Poor assessment of responsiveness is seen among users who experienced discrimination. CONCLUSION: This study revealed new associations between HSR and patient characteristics. Incorporating this knowledge in practice would help strengthen patient-centred health services by considering patient experiences and expectations. This highlights that HSR can be used as a tool to evaluate and promote patient-centred health services. Future research should investigate additional drivers of HSR, both on the patient and the provider sides.

Assessment of health system performance in Germany: Survey-based insights into the perspective of people with private health insurance.

INTRODUCTION: The World Health Organization (WHO) defined intermediate and overall goals to assess the performance of health systems. As the population perspective becomes more important for improving health systems, the aim of this study was to gain insights into the perspective of people with private health insurance (PHI) in Germany along the predefined WHO goals. METHODS: A cross-sectional survey was conducted in 2018 among people with PHI in Germany. The questionnaire included items on all intermediate (access, coverage, quality, and safety) and overall WHO goals (improved health, responsiveness, social and financial risk protection, and improved efficiency). Descriptive analyses were conducted for the total sample and subgroups (gender, age, income, and health status). RESULTS: In total, 3601 respondents (age 58.5 ± 14.6; 64.7% male) assessed the German health system. For example, 3.3%-7.5% of the respondents with subjective needs reported forgone care in the past 12 months due to waiting time, distance, or financial reasons and 14.4% suspected medical errors in their care. During the last physician visit 94.2% experienced respectful treatment but only 60.6% perceived coordination of care as good. Unnecessary health services were perceived by 24.2%. For many items significant subgroup differences were found, particularly for age groups (18-64 vs. 65+). CONCLUSION: Conducting a health system performance assessment from the population perspective gained new and unique insights into the perception of people with PHI in Germany. Areas to improve the health system were seen in, for example, coordination of care, financial risk protection, and quality of care, and inequalities between subgroups were identified.