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.

[Association between Safety Culture and Risk of Burnout: A Survey of Non-Medical Rescue Workers]. / Der Zusammenhang zwischen Sicherheitskultur und Burnout-Risiko: Eine Befragung nicht-ärztlicher Mitarbeiter im Rettungsdienst.

BACKGROUND: Stressors such as safety culture in organizations that increase the risk of burnout have been studied in nursing and inpatient care settings. However, investigations in the setting of preclinical emergency medical services (EMS) are still limited. The study aims at (1) investigating burnout in health care workers in preclinical EMS and their perceived safety culture, and (2) analyzing the association between the two. METHODS: Using the Maslach Burnout Inventory (MBI) and the Emergency Medical Services - Safety Attitudes Questionnaire (EMS-SAQ), an online survey was conducted with non-medical health care workers in preclinical EMS. Descriptive analyses were performed using frequencies, mean values, percentages and the Pearson correlation coefficient. A logistic regression model was used to determine the relationship between safety culture and the risk of burnout. RESULTS: A total of 1,101 questionnaires was considered for analysis. Most of the participants were male (86.2%) and younger than 40 years (73.2%). A high risk of burnout for participants was found for the dimensions of emotional exhaustion and depersonalization (EE 26.3% and DP 40.2%). In the context of measuring safety culture, especially management, working conditions, and safety climate were negatively perceived by the participants. Furthermore, high stress recognition (EE: OR=3.317, p<0.01; DP: OR=1.910, p<0.01), negative job satisfaction (EE: OR=0.297, p<0.01; DP: OR=0.576, p<0.01) and negatively perceived working conditions (EE: OR 0.598, p<0.05; DP: 0.937, p<0.05) were significantly associated with a high risk of burnout. CONCLUSION: This is the first large scale study investigating burnout among non-medical health care workers in preclinical EMS and their perceived safety culture in Germany as well as the association between the two. The results show the necessity to focus on perceived dimensions of safety culture in organizations, to develop measures reducing stress and improve job satisfaction and working conditions. In the context of increasing skills shortage, this is especially relevant with regard to the challenges of patient safety and quality of outcomes in care.

Physicians' Decision Making on Adoption of New Technologies and Role of Coverage with Evidence Development: A Qualitative Study.

OBJECTIVES: To foster value-based pricing and coverage with evidence development in Germany, certain new diagnostic and treatment methods have been subject to a benefit assessment since 2016 to determine their reimbursement. Although this is a paradigm shift, the German approach is limited to some few specific technologies for which reimbursement is requested. As physicians encounter this regulatory instrument, the aim of the study was to understand physicians' decision making regarding the adoption of new medical technologies and to identify their perspectives on the evidence base and financing with additional reimbursement systems. METHODS: From April to August 2017, semistructured interviews with chief and senior physicians of vascular surgery and cardiology in inpatient care in Germany were conducted (N = 23). The interviews were carried out by one researcher in one-to-one appointments or via telephone. Data were analyzed inductively to identify factors and generate thematic categories using qualitative content analysis. RESULTS: We identified 52 factors in eight categories influencing physicians' adoption of new technologies. The evidence base for new technologies was criticized (e.g., lack of available studies). Physicians' knowledge of the regulation of market approval and innovation payments varied. They recommended the utilization of new technologies in certain specialist centers and the facilitation of observational studies. CONCLUSIONS: Physicians saw the need for the new approach and supported its aim. However, its design and implementation appeared to be questionable from their medical perspective. The provision of summarized information on the benefit of technologies might be a possibility to assist physicians' decision making.

Burnout and safety outcomes - a cross-sectional nationwide survey of EMS-workers in Germany.

BACKGROUND: The association between burnout and patient safety has been analyzed in many studies for nurses, physicians, and residents. However, studies concerning prehospital emergency medical services (EMS) workers are limited, although they are particularly under risk for emotional stress. This study aims to descriptively analyze the overall degree of burnout among EMS-workers, and potential adverse events that might harm patients as well as the relationship between burnout and perceived safety outcomes for EMS-workers in Germany. METHODS: EMS-workers were recruited via German EMS-journals, social media and a professional association to participate in an online survey. The questionnaire includes the ´Maslach Burnout Inventory´ (MBI), the 'Emergency Medical Services Safety Inventory' (EMS-SI), and items about job satisfaction and the individual person. Data was descriptively analyzed by calculating frequencies, means, percentages and Pearson correlation coefficients. The association between burnout and patient safety was analyzed using linear and logistic regression models. RESULTS: A total of n = 1101 questionnaires were considered for data analysis. The vast majority of participants were male, younger than 40 years old, and full-time employees with an EMS-experience of 12 years on average. Between 19.9 and 40% of the participants showed a high degree of burnout in one of the burnout dimensions. Safety compromising behavior was the outcome measure with the highest percentage of participants reporting a negative outcome measure. The dimensions emotional exhaustion and depersonalization were positively associated with the safety outcomes injury and safety compromising behavior. Additionally, experiences, job satisfaction and the intention to leave the current job were significantly associated with the outcome measures. CONCLUSION: This is the first study that examines the association between the degree of burnout and patient safety for EMS-workers. The results suggest that an expansion of psychological support for EMS-workers should be considered. Further research should concentrate on the complex relations between working conditions, burnout and patient safety.

Patients' preferences in dental care: A discrete-choice experiment and an analysis of willingness-to-pay.

INTRODUCTION: Dental diseases are a major problem worldwide. Costs are a burden on healthcare systems and patients. Missed treatments can have health and financial consequences. Compared to other health services, dental treatments are only covered in parts by statutory health insurance (SHI). Using the example of dental crowns for a cost-intensive treatment, our study aims to investigate whether (1) certain treatment attributes determine patients' treatment choice, and (2) out-of-pocket payments represent a barrier to access dental care. METHODS: We conducted a discrete-choice-experiment by mailing questionnaires to 10,752 people in Germany. In presented scenarios the participants could choose between treatment options (A, B, or none) composed of treatment attribute levels (e.g., color of teeth) for posterior (PT) and anterior teeth (AT). Considering interaction effects, we used a D-efficient fractional factorial design. Choice analysis was performed using different models. Furthermore, we analyzed willingness-to-pay (WTP), preference of choosing no and SHI standard care treatment, and influence of socioeconomic characteristics on individual WTP. RESULTS: Out of n = 762 returned questionnaires (response rate of r = 7.1), n = 380 were included in the analysis. Most of the participants are in age group "50 to 59 years" (n = 103, 27.1%) and female (n = 249, 65.5%). The participants' benefit allocations varied across treatment attributes. Aesthetics and durability of dental crowns play most important roles in decision-making. WTP regarding natural color teeth is higher than standard SHI out-of-pocket payment. Estimations for AT dominate. For both tooth areas, "no treatment" was a frequent choice (PT: 25.7%, AT: 37.2%). Especially for AT, treatment beyond SHI standard care was often chosen (49.8%, PT: 31.3%). Age, gender, and incentive measures (bonus booklet) influenced WTP per participant. CONCLUSION: This study provides important insights into patient preferences for dental crown treatment in Germany. For our participants, aesthetic for AT and PT as well as out-of-pocket payments for PT play an important role in decision-making. Overall, they are willing to pay more than the current out-of-pockt payments for what they consider to be better crown treatments. Findings may be valuable for policy makers in developing measures that better match patient preferences.

Reasons for (not) choosing dental treatments-A qualitative study based on patients' perspective.

Oral health is increasingly seen as a public health challenge due to the remarkable prevalence of oral diseases worldwide, the impact on general health, and health consequences that can arise for individuals. Compared to other health services, oral health services are usually not fully covered by statutory health insurance, which is seen as one reason in decision-making on dental treatments. Nevertheless, patients' reasons for treatment decisions are not well understood although they can provide valuable insights. The objective of this study was to identify reasons of choice for dental treatments and to explore patients' view on cost coverage in Germany. We conducted four focus group interviews with a total of 27 participants. The interviews were audiotaped and transcribed verbatim. Data was analyzed performing conventional content analysis. As part of a qualitative analysis, subcategories and categories were formed from identified reasons using an inductive approach. Our study supports and expands research in exploring patients' decision-making on dental treatments. It highlights a variety of 53 reasons of choice for dental treatments from patients' perspective, split in two categories "health care service", and "dentist & dental office". First category includes reasons regarding dental care performance (subcategories: "preconditions", "treatment", "costs", and "outcomes"). Second category demonstrates reasons regarding dentists, office structures and processes (subcategories: "professional skills", "social skills", "office staff & equipment", and "office processes"). Reasons named "most important" by the participants are out-of-pocket payments, dentists' training, and a relationship of trust between patient and dentist. Although the participants use incentive measures to lower financial burden, several perceived challenges exist. Identified reasons for choosing dental treatments provide a basis for further studies to quantify the relevance of these reasons from patients' perspective. Based on this, the various reasons identified can be considered in future policies to improve patients' utilization behavior, which can range from improved information sources to increased incentive measures.

Implementation of innovative medical technologies in German inpatient care: patterns of utilization and evidence development.

BACKGROUND: Innovative medical technologies are commonly associated with positive expectations. At the time of their introduction into care, there is often little evidence available regarding their benefits and harms. Accordingly, some innovative medical technologies with a lack of evidence are used widely until or even though findings of adverse events emerge, while others with study results supporting their safety and effectiveness remain underused. This study aims at examining the diffusion patterns of innovative medical technologies in German inpatient care between 2005 and 2017 while simultaneously considering evidence development. METHODS: Based on a qualitatively derived typology and a quantitative clustering of the adoption curves, a representative sample of 21 technologies was selected for further evaluation. Published scientific evidence on efficacy/effectiveness and safety of the technologies was identified and extracted in a systematic approach. Derived from a two-dimensional classification according to the degree of utilization and availability of supportive evidence, the diffusion patterns were then assigned to the categories "Success" (widespread/positive), "Hazard" (widespread/negative), "Overadoption" (widespread/limited or none), "Underadoption" (cautious/positive), "Vigilance" (cautious/negative), and "Prudence" (cautious/limited or none). RESULTS: Overall, we found limited evidence on the examined technologies regarding both the quantity and quality of published randomized controlled trials. Thus, the categories "Prudence" and "Overadoption" together account for nearly three-quarters of the years evaluated, followed by "Success" with 17%. Even when evidence is available, the transfer of knowledge into practice appears to be inhibited. CONCLUSIONS: The successful implementation of safe and effective innovative medical technologies into practice requires substantial further efforts by policymakers to strengthen systematic knowledge generation and translation. Creating an environment that encourages the conduct of rigorous studies, promotes knowledge translation, and rewards innovative medical technologies according to their added value is a prerequisite for the diffusion of valuable health care.

[Jurisdictions on the reimbursement of new medical technologies by public health insurance: A systematic review]. / Rechtsprechungen zur Kostenerstattung von neuen Gesundheitstechnologien in der GKV: Eine systematische Übersicht.

BACKGROUND: In Germany reimbursement for new medical technologies is often enforced before a social court. It is likely that these judicial decisions also affect the sickness funds' decisions on requests for reimbursement and thus patient access to new technologies in general. OBJECTIVES: The aim of this study was to identify the technologies that have repeatedly generated court actions and whether these actions have been successful. The focus was on differences between sectors, technology groups and indications. Based on this, we analysed in a case study whether judicial decisions on the reimbursement of the same technologies vary across the years. MATERIAL AND METHODS: Based on a systematic review, we identified judicial decisions of German social courts on new technologies for the years 2011 to 2016. The analysis included social court decisions on reimbursements for technologies used in the treatment of individual patients. RESULTS: 284 judicial decisions on new technologies were considered in the analysis. In one third of the cases, the sickness funds were required to reimburse the costs, with a higher percentage in inpatient than in outpatient care. Technologies used in treatment of diseases of the eyes and the ears were granted most frequently. In cases involving similar circumstances the social courts sometimes came to conflicting decisions; these decisions are, in part, contradictory to subsequent assessments by the Joint Federal Committee (G-BA). CONCLUSIONS: Decisions as to whether reimbursement for new technologies is granted or not do not appear to follow a systematic approach. In the context of the seemingly innovation-friendly policy in inpatient care, there is uncertainty with regard to the "generally accepted state of medical knowledge." It is problematic for both patients and their treating physicians that over a number of years legal proceedings are being initiated for technologies that have not been subjected to a systematic assessment of their benefit.