Hearing Loss, Hearing Aid Use, and Risk of Dementia in Older Adults.

Importance: Hearing loss has been suggested as a risk factor for dementia, but there is still a need for high-quality research to better understand the association between these 2 conditions and the underlying causal mechanisms and treatment benefits using larger cohorts and detailed data. Objective: To investigate the association between hearing loss and incident dementia, as well as how hearing aid use contributes to this association. Design, Setting, and Participants: This population-based cohort study was conducted in Southern Denmark between January 2003 and December 2017 and included all residents 50 years and older. We excluded all persons with dementia before baseline as well as those who did not live in the region 5 years before baseline, with incomplete address history, or who had missing covariate information. Exposures: Individual hearing status based on the Hearing Examinations in Southern Denmark database, which contains data on all pure-tone audiometry examinations performed at public hearing rehabilitation clinics in Southern Denmark. Main Outcomes and Measures: Incident cases of dementia and Alzheimer disease as identified from national registries. Results: The study population comprised 573 088 persons (298 006 women [52%]; mean [SD] age, 60.8 [11.3] years) with 23 023 cases of dementia and mean (SD) follow-up of 8.6 (4.3) years. Having a hearing loss was associated with an increased risk of dementia, with an adjusted hazard ratio (HR) of 1.07 (95% CI, 1.04-1.11) compared with having no hearing loss. Severe hearing loss in the better and worse ear was associated with a higher dementia risk, with an HR of 1.20 (95% CI, 1.09-1.32) and 1.13 (95% CI, 1.06-1.20), respectively, compared with having no hearing loss in the corresponding ear. Compared with people without hearing loss, the risk of dementia was higher among people with hearing loss who were not using hearing aids than those who had hearing loss and were using hearing aids, with HRs of 1.20 (95% CI, 1.13-1.27) and 1.06 (95% CI, 1.01-1.10), respectively. Conclusions and Relevance: The results of this cohort study suggest that hearing loss was associated with increased dementia risk, especially among people not using hearing aids, suggesting that hearing aids might prevent or delay the onset and progression of dementia. The risk estimates were lower than in previous studies, highlighting the need for more high-quality longitudinal studies.

The Danish EQ-5D-5L Value Set: A Hybrid Model Using cTTO and DCE Data.

OBJECTIVES: Quality-adjusted life-years (QALYs) are expected to be used for priority setting of hospital-dispensed medicines in Denmark from 2021. The aim of this study was to develop the first Danish value set for the EQ-5D-5L based on interviews with a representative sample of the Danish adult population. METHODS: A nationally representative sample based on age (> 18 years), gender, education, and geographical region was recruited using data provided by Statistics Denmark. Computer-assisted personal interviews were carried out using the EQ-VT 2.1. Respondents each valued ten health states using composite time trade-off (cTTO) and seven health states using discrete-choice experiment (DCE). Different predictive models were explored using cTTO and DCE data alone or in combination as hybrid models. Model performance was assessed using logical consistency. RESULTS: A total of 1014 interviews were included in the analyses. The sample was representative of the Danish adult population, though the sample contained slightly more respondents with higher education than in the general population. Only the heteroscedastic censored hybrid model combining cTTO and DCE data yielded consistent results, and hence was chosen for modelling the final Danish value set. The predicted values ranged from - 0.757 to 1, and anxiety/depression was the dimension assigned most value by respondents. CONCLUSIONS: This study established the Danish EQ-5D-5L value set, which represents the preferences of the Danish general population, and is expected to provide key input for healthcare decision-making in a Danish context.

Test-retest reliability of ICECAP-A in the adult Danish population.

PURPOSE: To investigate the test-retest reliability of Investigating Choice Experiments Capability measure for Adults (ICECAP-A) in the adult Danish population. METHODS: The original English ICECAP-A was translated into Danish by forward-backwards translation using the guidelines by Beaton et al. Three hundred and-thirty-two participants with mean age of 57 years participated in a Web-based study. Data concerning relative and absolute agreement were analysed by the intra-class correlation coefficient and Bland-Altman plot with limits of agreement. The overall and item consistency was investigated by weighted kappa statistics from baseline to 2-week follow-up. Logistic regression was used to study the effect of the sociodemographic characteristics with inconsistent responses as the dependent binary variable. The independent variables were age, sex, education, income, and region of residence at baseline. RESULTS: The baseline ICECAP-A preference-based index score was 0.84, and at follow-up, 0.83. The ICC was 0.86 (95% CI 0.826-0.884), and limits of agreement were 0.164 and - 0.151. The kappa coefficient ranges from 45 to 65%, between random and perfect agreement. The logistic regression to analyse inconsistent responses showed no significant association between the overall index score and sociodemographic characteristics, and no clear pattern was found concerning the individual item inconsistency. CONCLUSIONS: Evidence regarding the reliability of the Danish version of ICECAP-A is satisfactory for both the index score agreement and the individual item consistency and is a reliable measure to be used in a Danish context and future health economic evaluations.

A qualitative exploration of early assessment of innovative medical technologies.

BACKGROUND: Hospitals increasingly make decisions about early development of and investment in innovative medical technologies (IMTs), but at present often without an early assessment of their potential to ensure selection of the most promising candidates for further development. This paper explores how early assessment is carried out in different health organisations and then discusses relevant learning points for hospitals. METHODS: A qualitative study design with a structured interview guide covering four themes was used. Content analyses of interview notes were performed covering four predetermined themes: context, basis for decision-making, process and structure, and perceptions. A fifth theme, handling cognitive bias, was identified during data analysis. RESULTS: A total of 11 organisations participated; eight from the private health industry and three public hospitals. The interviews identified four areas in which early assessment is performed in similar manner across the studied organisations and four areas where differences exist between public hospitals and private organisations. Public hospitals indicate a lower degree of formalised early assessment and less satisfaction with how early assessment is performed, compared to private organisations. Based on the above findings, two learning points may carry promise for hospitals. First, having dedicated prioritising committees for IMTs making stop/go decisions. This committee is separate from the IMT development processes and involved staff. Secondly, the committee should base decisions on a transparent early assessment decision-support tool, which include a broad set of domains, is iterative, describes uncertainty, and minimise cognitive biases. CONCLUSIONS: Similarities and differences in the way early assessment is done in different health organisations were identified. These findings suggest promising learning points for the development of an early assessment model for hospitals.

Examining the Heterogeneity and Cost Effectiveness of a Complex Intervention by Segmentation of Patients with Chronic Obstructive Pulmonary Disease.

OBJECTIVES: To examine the heterogeneity in cost-effectiveness analyses of patient-tailored complex interventions. METHODS: Latent class analysis (LCA) was performed on data from a randomized controlled trial evaluating a patient-tailored case management strategy for patients suffering from chronic obstructive pulmonary disease (COPD). LCA was conducted on detailed process variables representing service variation in the intervention group. Features of the identified latent classes were compared for consistency with baseline demographic, clinical, and economic characteristics for each class. Classes for the control group, corresponding to the identified latent classes for the intervention group, were identified using multinomial logistic regression. Cost-utility analyses were then conducted at the class level, and uncertainty surrounding the point estimates was assessed by probabilistic sensitivity analysis. RESULTS: The LCA identified three distinct classes: the psychologically care class, the extensive COPD care class, and the limited COPD care class. Patient baseline characteristics were in line with the features identified in the LCA. Evaluation of cost-effectiveness revealed highly disparate results, and case management for only the extensive COPD care class appeared cost-effective with an incremental cost-effectiveness ratio of £26,986 per quality-adjusted life-year gained using the threshold value set by the National Institute of Health and Care Excellence. CONCLUSIONS: Findings indicate that researchers evaluating patient-tailored complex interventions need to address both supply-side variation and demand-side heterogeneity to link findings with outcome. The article specifically proposes the use of LCA because it is believed to have the potential to enable more appropriate targeting of complex care strategies.

Cost-effectiveness of telemonitoring of diabetic foot ulcer patients.

This study compared the cost-effectiveness of telemonitoring with standard monitoring for patients with diabetic foot ulcers. The economic evaluation was nested within a pragmatic randomised controlled trial. A total of 374 patients were randomised to either telemonitoring or standard monitoring. Telemonitoring consisted of two tele-consultations in the patient's own home and one consultation at the outpatient clinic; standard monitoring consisted of three outpatient clinic consultations. Total healthcare costs were estimated over a 6-month period at individual patient level, from a healthcare sector perspective. The bootstrap method was used to calculate the incremental cost-effectiveness ratio, and one-way sensitivity analyses were performed. Telemonitoring costs were found to be €2039 less per patient compared to standard monitoring; however, this difference was not statistically significant. Amputation rate was similar in the two groups. In conclusion, a telemonitoring service in this form had similar costs and effects as standard monitoring.

How is defensive medicine understood and experienced in a primary care setting? A qualitative focus group study among Danish general practitioners.

OBJECTIVES: Recent years have witnessed a progressive increase in defensive medicine (DM) in several Western welfare countries. In Danish primary and secondary care, documentation on the extent of DM is lacking. Before investigating the extent of DM, we wanted to explore how the phenomenon is understood and experienced in the context of general practice in Denmark. The objective of the study was to describe the phenomenon of DM as understood and experienced by Danish general practitioners (GPs). DESIGN: A qualitative methodology was employed and data were generated through six focus group interviews with three to eight GPs per group (n=28) recruited from the Region of Southern Denmark. Data were analysed using a thematic content analysis inspired by a hermeneutic-phenomenological focus on understanding and meaning. RESULTS: DM is understood as unnecessary and meaningless medical actions, carried out mainly because of external demands that run counter to the GP's professionalism. Several sources of pressure to act defensively were identified by the GPs: the system's pressure to meet external regulations, demands from consumerist patients and a culture among GPs and peers of infallibility and zero-risk tolerance. CONCLUSIONS: GPs understand DM as unnecessary and meaningless actions driven by external demands instead of a focus on the patient's problem. GPs consider defensive actions to be carried out as a result of succumbing to various sources of pressure deriving from the system, the patients, the GPs themselves and peers.

Review of early assessment models of innovative medical technologies.

INTRODUCTION: Hospitals increasingly make decisions regarding the early development of and investment in technologies, but a formal evaluation model for assisting hospitals early on in assessing the potential of innovative medical technologies is lacking. This article provides an overview of models for early assessment in different health organisations and discusses which models hold most promise for hospital decision makers. METHODS: A scoping review of published studies between 1996 and 2015 was performed using nine databases. The following information was collected: decision context, decision problem, and a description of the early assessment model. RESULTS: 2362 articles were identified and 12 studies fulfilled the inclusion criteria. An additional 12 studies were identified and included in the review by searching reference lists. The majority of the 24 early assessment studies were variants of traditional cost-effectiveness analysis. Around one fourth of the studies presented an evaluation model with a broader focus than cost-effectiveness. Uncertainty was mostly handled by simple sensitivity or scenario analysis. DISCUSSION AND CONCLUSIONS: This review shows that evaluation models using known methods assessing cost-effectiveness are most prevalent in early assessment, but seems ill-suited for early assessment in hospitals. Four models provided some usable elements for the development of a hospital-based model.

General practitioners' attitudes towards and experiences with referrals due to supplemental health insurance.

Background: Supplemental health insurances (SHI) cover 38% of the Danish population. SHI can give faster access to, and additional treatment from, private health providers. However, this is contingent on a referral from the general practitioner (GP), further complicating clinical decision-making. Objectives: To describe GPs' attitudes to SHI and their experiences with patients holding SHI. Moreover, we analysed associations between different GP characteristics; e.g. gender, age, practice type, own SHI status and their attitudes to and experiences with SHI. Methods: A questionnaire was mailed to 3321 GPs focusing on three issues: (i) Attitudes towards the public health care system. (ii) Perceptions of the impact of SHI. (iii) Experiences with patients holding SHIs. Results: The response rate was 64%. Overall, GPs found that SHIs contribute to inequality (83%) and overtreatment (90%). However, 46% often feel under pressure to refer SHI patients to specialist care, even though not medically indicated, while 11% always or often refer SHI patients unconditionally. Both groups perceive SHI patients more insistent on getting referrals than patients without SHI. Conclusion: Even though a majority of GPs associate SHI with overtreatment and inequality in health, many GPs feel under pressure to refer patients holding SHI for treatments or examinations that are not medically warranted. Some GPs even refer these patients without further examination or questioning. Insistent SHI patients may partly explain this paradox. Future research should illuminate SHI patients' courses in the private as well as the public healthcare system with regards to medical indications and health outcome measures focusing on inequality and overtreatment.

Economic evaluation of an implementation strategy for the management of low back pain in general practice.

In connection with the publication of a clinical practice guideline on the management of low back pain (LBP) in general practice in Denmark, a cluster randomised controlled trial was conducted. In this trial, a multifaceted guideline implementation strategy to improve general practitioners' treatment of patients with LBP was compared with a usual implementation strategy. The aim was to determine whether the multifaceted strategy was cost effective, as compared with the usual implementation strategy. The economic evaluation was conducted as a cost-utility analysis where cost collected from a societal perspective and quality-adjusted life years were used as outcome measures. The analysis was conducted as a within-trial analysis with a 12-month time horizon consistent with the follow-up period of the clinical trial. To adjust for a priori selected covariates, generalised linear models with a gamma family were used to estimate incremental costs and quality-adjusted life years. Furthermore, both deterministic and probabilistic sensitivity analyses were conducted. Results showed that costs associated with primary health care were higher, whereas secondary health care costs were lower for the intervention group when compared with the control group. When adjusting for covariates, the intervention was less costly, and there was no significant difference in effect between the 2 groups. Sensitivity analyses showed that results were sensitive to uncertainty. In conclusion, the multifaceted implementation strategy was cost saving when compared with the usual strategy for implementing LBP clinical practice guidelines in general practice. Furthermore, there was no significant difference in effect, and the estimate was sensitive to uncertainty.

Economic Evaluation of Community-Based Case Management of Patients Suffering From Chronic Obstructive Pulmonary Disease.

OBJECTIVES: To analyse the cost effectiveness of community-based case management for patients suffering from chronic obstructive pulmonary disease (COPD). METHODS: The study took place in the third largest municipality in Denmark and was conducted as a randomised controlled trial with 12 months of follow-up. A total of 150 patients with COPD were randomised into two groups receiving usual care and case management in addition to usual care. Case management included among other things self care proficiency, medicine compliance, and care coordination. Outcome measure for the analysis was the incremental cost-effectiveness ratio (ICER) as cost per quality-adjusted life year (QALY) from the perspective of the healthcare sector. Costs were valued in British Pounds (£) at price level 2016. Scenario analyses and probabilistic sensitivity analyses were conducted in order to assess uncertainty of the ICER estimate. RESULTS: The intervention resulted in a QALY improvement of 0.0146 (95% CI -0.0216; 0.0585), and a cost increase of £494 (95% CI -1778; 2766) per patient. No statistically significant difference was observed either in costs or effects. The ICER was £33,865 per QALY gained. Scenario analyses confirmed the robustness of the result and revealed slightly lower ICERs of £28,100-£31,340 per QALY. CONCLUSIONS: Analysis revealed that case management led to a positive incremental QALY, but were more costly than usual care. The highly uncertain ICER somewhat exceeds for instance the threshold value used by the National Institute of Health and Care Excellence (NICE). No formally established Danish threshold value exists. ClinicalTrials.gov Identifier: NCT01512836.

Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial.

BACKGROUND: In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation. METHODS/DESIGN: The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon. DISCUSSION: It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes, thereby rendering the extended implementation strategy cost-effective. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01699256.

Economies of scale and scope in the Danish hospital sector prior to radical restructuring plans.

OBJECTIVE: The Danish hospital sector faces a significant rebuilding program driven by recent regional reform and guidelines for acute admission hospitals. Within the next 5-10 years, the number of public hospitals offering acute admission will be reduced from 35 to approximately 20 larger hospitals. As the administrative data may be biased during the middle of a restructuring process our objective was to analyze whether the configuration of Danish public hospitals was subject to economies of scale and scope prior to the restructuring plans. METHODS: We estimated a quadratic cost function using panel data on the total costs for somatic treatment, casemix adjusted DRG-production values, and other cost drivers for the three years before the 2007 reforms. A short-run cost function was used to derive estimates of a long-run cost function by applying the envelope condition. Next, we estimated economies of scale and scope. RESULTS: We identified moderate-to-significant economies of scale and scope. This indicates that the Danish hospital sector was characterized by unexploited gains from consolidation. CONCLUSIONS: Our results suggest that the proposed plans have the potential to result in hospitals that are more efficient. However, post-restructuring studies elsewhere show that the strategy of horizontal integration has failed.

General practice and primary health care in Denmark.

General practice is the corner stone of Danish primary health care. General practitioners (GPs) are similar to family physicians in the United States. On average, all Danes have 6.9 contacts per year with their GP (in-person, telephone, or E-mail consultation). General practice is characterized by 5 key components: (1) a list system, with an average of close to 1600 persons on the list of a typical GP; (2) the GP as gatekeeper and first-line provider in the sense that a referral from a GP is required for most office-based specialists and always for in- and outpatient hospital treatment; (3) an after-hours system staffed by GPs on a rota basis; (4) a mixed capitation and fee-for-service system; and (5) GPs are self-employed, working on contract for the public funder based on a national agreement that details not only services and reimbursement but also opening hours and required postgraduate education. The contract is (re)negotiated every 2 years. General practice is embedded in a universal tax-funded health care system in which GP and hospital services are free at the point of use. The current system has evolved over the past century and has shown an ability to adapt flexibly to new challenges. Practice units are fairly small: close to 2 GPs per unit plus nurses and secretaries. The units are fully computerized, that is, with computer-based patient records and submission of prescriptions digitally to pharmacies etc. Over the past few years a decrease in solo practices has been seen and is expected to accelerate, in part because of the GP age structure, with many GPs retiring and new GPs not wanting to practice alone. This latter workforce trend is pointing toward a new model with employed GPs, particularly in rural areas.

Use of evidence in local public health work in Denmark.

OBJECTIVE: The aim was to investigate how and on which level evidence is used in policy processes related to local public health work in Denmark. METHOD: A survey was carried out in municipalities in Denmark (n = 98, response rate 81%) with health managers as respondents. RESULTS: A large variation in understanding of the concept of evidence was found. Less than half of the health managers expressed that evidence is used at a high level. The health managers' emphasis on use of evidence, political desire for use of evidence and evidence capacity were associated with the actual use. The health managers' educational background and size of municipalities had no association to this. A request for more use of evidence was found. Barriers for this were conditions connected to time and competences. Increased collaboration between municipalities, collaboration with research units, and guidelines for evidence use were suggested as facilitators. CONCLUSION: There is a need for development and dissemination of methods for working with evidence-based public health in Danish municipalities.

Danish EQ-5D population norms.

BACKGROUND: The EQ-5D is a widely used generic health-related quality of life instrument that has been used to describe population health and health outcomes in clinical trials and health economic evaluations. AIMS: To generate Danish population norms for the EQ-5D index score, stratified by age and gender. METHODS: The EQ-5D data from three population health surveys were pooled, thus providing EQ-5D profile data for 15,700 individuals aged 20-79 years. The Danish TTO scoring algorithm was used to weight each respondent's profile data to derive a single index score. Mean values were computed by gender and 10-year age groups, and educational groups. RESULTS: In a random sample from the general Danish population, the mean EQ-5D index score ranged between 0.93 for 20-29 year-olds and 0.83 for 70-79 year-olds. Men had a significantly higher score than women in all age groups. Longer education was associated with higher EQ-5D index score in most age groups. CONCLUSIONS: The calculated mean values for the EQ-5D index score may be used as reference values for comparative purposes in future Danish population health and evaluative studies.

[Economic evaluation of a tablet-based vaccination against hay fever in Denmark]. / Økonomisk evaluering af tabletbaseret vaccine mod høfeber i Danmark.

INTRODUCTION: Hay fever (allergic rhinoconjunctivitis) is a frequent disease and 12% of the Danish adult population suffer from grass-pollen induced hay fever. Symptomatic medication is the traditional treatment, while immunotherapy with sustained effect is an alternative. Grazax (Phleum pratense, ALK-Abelló) is a new tablet-based vaccination against grass-pollen induced hay fever. The aim was to investigate the cost-effectiveness of the tablet-based vaccination of grass-pollen induced hay fever in Denmark. MATERIALS AND METHODS: Based on a prospective collection of data as part of a clinical trial cost and quality of life (QALY) data for 493 patients, the tablet-based vaccine (Grazax) was compared in a cost-utility analysis (societal perspective) with symptomatic treatment. The analysis was based on three years of immunotherapy followed by six years of sustained effect. RESULTS: Significant more QALYs were gained from using the tablet-based vaccine (0.9799) compared with traditional symptomatic treatment (0.9567), which with a nine-year time horizon corresponds to 0.19 extra QALYs. The costs of vaccination against hay fever were DKK 34,498. With a nine-year time horizon, the cost per extra QALY from using the tablet-based vaccine was DKK 52,646 or DKK 134,105, focussing on direct costs alone. These results are below the unofficial thresholds for what the costs of a QALY should be. CONCLUSION: The analysis has shown that tablet-based immunotherapy (Grazax) for the treatment of hay fever results in an improved quality of life and that it is a cost-effective choice.

[Costs attributed to hospital-acquired infections]. / Hospitalsinfektioner--en samfundsøkonomisk udfordring.

The literature on costs associated with hospital-acquired infections is critically evaluated and exemplified. There are considerable added costs attributed to hospital infections. Two types of analyses are discussed: cost-of-illness studies, COIs, typically without a societal cost perspective, and cost-effectiveness studies. It is a mistake to think that costs calculated in COIs can be used as estimates of potential savings in cost-effectiveness analyses. As a general rule, this is not the case. The calculation of unit costs and marginal costs are common weaknesses in most studies.