Cost of non-communicable diseases in people living with HIV in the Central Denmark Region.

OBJECTIVE: To estimate the economic burden of non-communicable diseases (NCDs) in people living with HIV (PLWH) in Denmark. METHODS: We conducted a cohort study using population-based Danish medical registries including all adult residents of the Central Denmark Region registered with a first-time HIV-diagnosis during the period 2006-2017. For each PLWH, we matched 10 persons without HIV from the background population by birth year, sex and municipality of residence. Information on healthcare utilization and costs for the PLWH and non-HIV cohorts was retrieved from register data. For each cohort, we estimated the annual costs for major disease categories (HIV care, other somatic care, and psychiatric care) in the period from 3 years before to 9 years after diagnosis/matching date. RESULTS: We identified 407 PLWH and 4070 persons from the background population. The total healthcare costs during the study period were approximately three times higher for PLWH compared to the non-HIV cohort (€76 198 vs. €23 692). Average annual cost of hospital care, primary care and selected prescription medicine was estimated to be €6987 per year in the years after the diagnosis compared to €2083 per year in the non-HIV cohort. In PLWH, the cost of NCDs and psychiatric care was approximately two times higher than the cost of HIV care. CONCLUSION: PLWH have higher healthcare costs stemming from three areas: excess cost due to the HIV infection, the treatment of NCDs, and psychiatric care.

Does a corticosteroid injection plus exercise or exercise alone add to the effect of patient advice and a heel cup for patients with plantar fasciopathy? A randomised clinical trial.

OBJECTIVE: To compare the effectiveness of patient advice plus heel cup alone (PA) versus PA and lower limb exercise (PAX) versus PAX plus corticosteroid injection (PAXI) to improve self-reported pain in patients with plantar fasciopathy. METHODS: We recruited 180 adults with plantar fasciopathy confirmed by ultrasonography for this prospectively registered three-armed, randomised, single-blinded superiority trial. Patients were randomly allocated to PA (n=62), PA plus self-dosed lower limb heavy-slow resistance training consisting of heel raises (PAX) (n=59), or PAX plus an ultrasound-guided injection of 1 mL triamcinolone 20 mg/mL (PAXI) (n=59). The primary outcome was changed in the pain domain of the Foot Health Status Questionnaire (ranging from 0 'worst' to 100 'best') from baseline to the 12-week follow-up. The minimal important difference in the pain domain is 14.1 points. The outcome was collected at baseline and at 4, 12, 26, and 52 weeks. RESULTS: The primary analysis found a statistically significant difference between PA and PAXI after 12 weeks favouring PAXI (adjusted mean difference: -9.1 (95% CI -16.8 to -1.3; p=0.023)) and over 52 weeks (adjusted mean difference: -5.2 (95% CI -10.4 to -0.1; p=0.045)). At no follow-up did the mean difference between groups exceed the pre-specified minimal important difference. No statistically significant difference was found between PAX and PAXI or between PA and PAX at any time. CONCLUSION: No clinically relevant between-group differences were found after 12 weeks. The results indicate that combining a corticosteroid injection with exercise is not superior to exercise or no exercise. TRIAL REGISTRATION NUMBER: NCT03804008.

The Clinical Effectiveness of Blended Cognitive Behavioral Therapy Compared With Face-to-Face Cognitive Behavioral Therapy for Adult Depression: Randomized Controlled Noninferiority Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (FtF) consultations in a blended format may produce a new treatment format (B-CBT) with multiple benefits from both traditional CBT and iCBT, such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation. OBJECTIVE: The primary aim of this study is to compare directly the clinical effectiveness of B-CBT with FtF-CBT for adult major depressive disorder. METHODS: A 2-arm randomized controlled noninferiority trial compared B-CBT for adult depression with treatment as usual (TAU). The trial was researcher blinded (unblinded for participants and clinicians). B-CBT comprised 6 sessions of FtF-CBT alternated with 6-8 web-based CBT self-help modules. TAU comprised 12 sessions of FtF-CBT. All participants were aged 18 or older and met the diagnostic criteria for major depressive disorder and were recruited via a national iCBT clinic. The primary outcome was change in depression severity on the 9-item Patient Health Questionnaire (PHQ-9). Secondary analyses included client satisfaction (8-item Client Satisfaction Questionnaire [CSQ-8]), patient expectancy (Credibility and Expectancy Questionnaire [CEQ]), and working (Working Alliance Inventory [WAI] and Technical Alliance Inventory [TAI]). The primary outcome was analyzed by a mixed effects model including all available data from baseline, weekly measures, 3-, 6, and 12-month follow-up. RESULTS: A total of 76 individuals were randomized, with 38 allocated to each treatment group. Age ranged from 18 to 71 years (SD 13.96) with 56 (74%) females. Attrition rate was 20% (n=15), which was less in the FtF-CBT group (n=6, 16%) than in the B-CBT group (n=9, 24%). As many as 53 (70%) completed 9 or more sessions almost equally distributed between the groups (nFtF-CBT=27, 71%; nB-CBT=26, 68%). PHQ-9 reduced 11.38 points in the FtF-CBT group and 8.10 in the B-CBT group. At 6 months, the mean difference was a mere 0.17 points. The primary analyses confirmed large and significant within-group reductions in both groups (FtF-CBT: ß=-.03; standard error [SE] 0.00; P<.001 and B-CBT: ß=-.02; SE 0.00; P<.001). A small but significant interaction effect was observed between groups (ß=.01; SE 0.00; P=.03). Employment status influenced the outcome differently between groups, where the B-CBT group was seen to profit more from not being full-time employed than the FtF group. CONCLUSIONS: With large within-group effects in both treatment arms, the study demonstrated feasibility of B-CBT in Denmark. At 6 months' follow-up, there appeared to be no difference between the 2 treatment formats, with a small but nonsignificant difference at 12 months. The study seems to demonstrate that B-CBT is capable of producing treatment effects that are close to FtF-CBT and that completion rates and satisfaction rates were comparable between groups. However, the study was limited by small sample size and should be interpreted with caution. TRIAL REGISTRATION: ClinicalTrials.gov NCT02796573; https://clinicaltrials.gov/ct2/show/NCT02796573. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-016-1140-y.

Mobile Diary App Versus Paper-Based Diary Cards for Patients With Borderline Personality Disorder: Economic Evaluation.

BACKGROUND: The cost-effectiveness of using a mobile diary app as an adjunct in dialectical behavior therapy (DBT) in patients with borderline personality disorder is unknown. OBJECTIVE: This study aims to perform an economic evaluation of a mobile diary app compared with paper-based diary cards in DBT treatment for patients with borderline personality disorder in a psychiatric outpatient facility. METHODS: This study was conducted alongside a pragmatic, multicenter, randomized controlled trial. The participants were recruited at 5 Danish psychiatric outpatient facilities and were randomized to register the emotions, urges, and skills used in a mobile diary app or on paper-based diary cards. The participants in both groups received DBT delivered by the therapists. A cost-consequence analysis with a time horizon of 12 months was performed. Consequences included quality-adjusted life years (QALYs), depression severity, borderline severity, suicidal behavior, health care use, treatment compliance, and system usability. All relevant costs were included. Focus group interviews were conducted with patients, therapists, researchers, and industry representatives to discuss the potential advantages and disadvantages of using a mobile diary app. RESULTS: A total of 78 participants were included in the analysis. An insignificantly higher number of participants in the paper group dropped out before the start of treatment (P=.07). Of those starting treatment, participants in the app group had an average of 37.1 (SE 27.55) more days of treatment and recorded an average of 3.16 (SE 5.10) more skills per week than participants in the paper group. Participants in both groups had a QALY gain and a decrease in depression severity, borderline severity, and suicidal behavior. Significant differences were found in favor of the paper group for both QALY gain (adjusted difference -0.054; SE 0.03) and reduction in depression severity (adjusted difference -1.11; SE 1.57). The between-group difference in total costs ranged from US $107.37 to US $322.10 per participant during the 12 months. The use of services in the health care sector was similar across both time points and groups (difference: psychiatric hospitalization <5 and <5; general practice -1.32; SE 3.68 and 2.02; SE 3.19). Overall, the patients showed high acceptability and considered the app as being easy to use. Therapists worried about potential negative influences on the therapist-patient interaction from new work tasks accompanying the introduction of the new technology but pointed at innovation potential from digital database registrations. CONCLUSIONS: This study suggests both positive and negative consequences of mobile diary apps as adjuncts to DBT compared with paper diary cards. More research is needed to draw conclusions regarding its cost-effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov NCT03191565; http://clinicaltrials.gov/ct2/show/NCT03191565. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/17737.

Can quality improvement improve the quality of care? A systematic review of reported effects and methodological rigor in plan-do-study-act projects.

BACKGROUND: The Plan-Do-Study-Act (PDSA) method is widely used in quality improvement (QI) strategies. However, previous studies have indicated that methodological problems are frequent in PDSA-based QI projects. Furthermore, it has been difficult to establish an association between the use of PDSA and improvements in clinical practices and patient outcomes. The aim of this systematic review was to examine whether recently published PDSA-based QI projects show self-reported effects and are conducted according to key features of the method. METHODS: A systematic literature search was performed in the PubMed, Embase and CINAHL databases. QI projects using PDSA published in peer-reviewed journals in 2015 and 2016 were included. Projects were assessed to determine the reported effects and the use of the following key methodological features; iterative cyclic method, continuous data collection, small-scale testing and use of a theoretical rationale. RESULTS: Of the 120 QI projects included, almost all reported improvement (98%). However, only 32 (27%) described a specific, quantitative aim and reached it. A total of 72 projects (60%) documented PDSA cycles sufficiently for inclusion in a full analysis of key features. Of these only three (4%) adhered to all four key methodological features. CONCLUSION: Even though a majority of the QI projects reported improvements, the widespread challenges with low adherence to key methodological features in the individual projects pose a challenge for the legitimacy of PDSA-based QI. This review indicates that there is a continued need for improvement in quality improvement methodology.

Implementing patient-reported outcomes in clinical decision-making within knee and hip osteoarthritis: an explorative review.

BACKGROUND: In the past few decades, there has been an increasing focus on the importance of patient involvement in the health care system. Patient participation executed through patient-reported outcomes (PROs) and the integration of such into clinical practice has been framed as positive for patients, care providers, and the health care system as a whole. This review aims to elucidate and discuss the current and future use of PROs in clinical practice and to identify the most common types of PRO measures (PROMs) used for patients with hip or knee osteoarthritis in different treatment settings. METHODS: The following databases were searched: PubMed, Embase, CINAHL, Scopus, the Cochrane Library, and EconLit. For inclusion in the study, studies had to cover either knee or hip osteoarthritis and report on PROs. The type of PROM, treatment setting, and study design of each included study were extracted from their respective abstracts. Additionally, the full text of studies concerning PROs as an integrated part of clinical practice was examined and information on the year of publication, study design, topic, and use of PROMs was extracted. RESULTS: It was found that only two pilot studies reported on the use of PROs as an integrated part of patient treatment within hip or knee osteoarthritis. In 349 studies, a total of 38 different PROMs relevant for patients with either hip or knee osteoarthritis were identified. The EQ-5D, WOMAC, and VAS questionnaires were the most commonly reported generic, disease-specific, and domain-specific PROMs, respectively. However, a large variation in the use of different PROMs both within and between surgical and nonsurgical settings was found. CONCLUSION: Limited evidence on the use of PROs as an integrated part of clinical practice for patients with hip and knee osteoarthritis was found. Further research is necessary to clarify the effects on patient outcomes of using PROs in clinical practice. In addition, there is limited agreement on a joint standard for the use of PROMs both within and across the sectorial boarders. Further exploration of PROMs to generate future standardisation is suggested.

Attitudes towards accreditation among hospital employees in Denmark: a cross-sectional survey.

OBJECTIVE: To evaluate attitudes towards accreditation and the Danish Quality Model (DDKM) among hospital employees in Denmark. Negative attitudes led the Danish Government to abolish accreditation in 2015. DESIGN: A cross-sectional survey was carried out via web-based questionnaire. SETTING: All hospital managers, quality improvement staff (quality managers and employees), and hospital surveyors in Denmark; and clinicians (doctors and nurses) within nine selected specialties. PARTICIPANTS: Overall response rate was 29% with 5055 of 17 646 valid responses included in the data analysis. The response rate was 82% (5055/6188) among respondents who clicked on the link in the mail containing the questionnaire. METHODS: A short questionnaire was designed using a 7-point Likert scale ranging from 1 'strongly disagree' to 7 'strongly agree'. To compare mean values between respondent groups, regression analysis using dummy coding of respondent groups and calculation of standardized mean difference effect sizes were performed. RESULTS: Overall attitudes were supportive, with physicians more skeptical. There were different patterns of attitudes in the five Danish regions and between medical professions. A small group of physicians was extremely negative. CONCLUSION: Clinical attitudes are important, and can affect Government decisions. On the basis of our study, future attention should be paid to attitudes towards accreditation (and attitudes towards other means of quality improvement). Attitudes may reflect political agendas and impede the take-up of improvement programs, cause their demise, or reduce their effectiveness.

Unannounced versus announced hospital surveys: a nationwide cluster-randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of unannounced versus announced surveys in detecting non-compliance with accreditation standards in public hospitals. DESIGN: A nationwide cluster-randomized controlled trial. SETTING AND PARTICIPANTS: All public hospitals in Denmark were invited. Twenty-three hospitals (77%) (3 university hospitals, 5 psychiatric hospitals and 15 general hospitals) agreed to participate. INTERVENTION: Twelve hospitals were randomized to receive unannounced surveys (intervention group) and eleven hospitals to receive announced surveys (control group). We hypothesized that the hospitals receiving the unannounced surveys would reveal a higher degree of non-compliance with accreditation standards than the hospitals receiving announced surveys. Nine surveyors trained and employed by the Danish Institute for Quality and Accreditation in Healthcare (IKAS) were randomized into teams and conducted all surveys. MAIN OUTCOME MEASURE: The outcome was the surveyors' assessment of the hospitals' level of compliance with 113 performance indicators-an abbreviated set of the Danish Healthcare Quality Programme (DDKM) version 2, covering organizational standards, patient pathway standards and patient safety standards. Compliance with performance indicators was analyzed using binomial regression analysis with bootstrapped robust standard errors. RESULTS: In all, 16 202 measurements were acceptable for data analysis. The risk of observing non-compliance with performance indicators for the intervention group compared with the control group was statistically insignificant (risk difference (RD) = -0.6 percentage points [-2.51-1.31], P = 0.54). A converged analysis of the six patient safety critical standards, requiring 100% compliance to gain accreditation status revealed no statistically significant difference (RD = -0.78 percentage points [-4.01-2.44], P = 0.99). CONCLUSIONS: Unannounced hospital surveys were not more effective than announced surveys in detecting quality problems in Danish hospitals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02348567, https://clinicaltrials.gov/ct2/show/NCT02348567?term=NCT02348567.

Implementing teleophthalmology services to improve cost-effectiveness of the national eye care system.

BACKGROUND AND PURPOSE: Optometrist-assisted and teleophthalmology-enabled referral pathway (OTRP) for community optometry referrals has the potential to improve the capacity and efficiency of eye care delivery systems through risk stratification and limiting the number of improved referrals. This study investigates the expected future costs and benefits of implementing OTRP under various possible organizational set-ups relevant to a Danish context. METHODS: A decision-analytic model (decision tree) with a one-year time horizon was constructed to portray alternative future patient referral pathways for people examined in optometry stores for suspected ocular posterior segment eye disease. The main outcomes were total healthcare costs per patient, average waiting time from eye examination in store until the start of treatment or end of referral pathway, and quality-adjusted life-years (QALY) gained. The economic evaluation compares the general ophthalmologist referral pathway (GO-RP) with a potential reimbursement model for the optometrist-assisted teleophthalmology referral pathways (R-OTRP) and a procurement model for the optometrist-assisted teleophthalmology referral pathways (P-OTRP). RESULTS: The cost per individual with suspected ocular posterior segment eye disease was estimated to be £116 for GO-RP and £75 and £94 for P-OTRP and R-OTRP respectively. The average waiting time for diagnosis or end of referral pathway was 25 weeks for GO-RP and 5.8 and 5.7 for P-OTPR and R-OTPR respectively. QALY gain was 0.15 for P-OTRP/R-OTRP compared to 0.06 for GO-RP. CONCLUSION: OTRP is effective in reducing unnecessary referrals and waiting times, increasing patients' HRQoL, and decreasing the costs of diagnosing individuals with suspected ocular posterior segment eye disease.

OPCAB surgery is cost-effective for elderly patients.

OBJECTIVE: To determine the cost-effective operative strategy for coronary artery bypass surgery in patients above 70 years. DESIGN: Randomized, controlled trial of 900 patients above 70 years of age subjected to coronary artery bypass surgery. Patients were randomized to either on-pump or off-pump coronary artery bypass surgery. Data on direct and indirect costs were prospectively collected. Preoperatively and six months postoperatively, quality of life was assessed using EuroQol-5D questionnaires. Perioperative in-hospital costs and costs of re-intervention were included. RESULTS: The Summary Score of EuroQol-5D increased in both groups between preoperatively and postoperatively. In the on-pump group, it increased from 0.75 (0.16) (mean (SD)) to 0.84 (0.17), while the increase in the off-pump group was from 0.75 (0.15) to 0.84 (0.18). The difference between the groups was 0.0016 QALY and not significantly different. The mean costs were 148.940 D.Kr (CI, 130.623 D.Kr-167.252 D.Kr) for an on-pump patient and 138.693 D.Kr (CI, 123.167 D.Kr-154.220 D.Kr) for an off-pump patient. The ICER base-case point estimate was 6,829,999 D.Kr/QALY. The cost-effectiveness acceptability curve showed 89% probability of off-pump being cost-effective at a threshold value of 269,400 D.Kr/QALY. CONCLUSIONS: Off-pump surgery tends to be more cost-effective than on-pump surgery. Long-term comparisons are warranted.

A Systematic Review of Cost-Effectiveness Studies of Newer Non-Insulin Antidiabetic Drugs: Trends in Decision-Analytical Models for Modelling of Type 2 Diabetes Mellitus.

BACKGROUND: We performed a systematic overview of the cost-effectiveness analyses (CEAs) comparing Non-insulin antidiabetic drugs (NIADs) with other NIADs for the treatment of type 2 diabetes mellitus (T2DM), using decision-analytical modelling (DAM), focusing on both the economic results and the underlying methodological choices. METHODS: Eligible studies were CEAs using DAM to compare NIADs within the glucagon-like peptide-1 (GLP1) receptor agonists, sodium-glucose cotransporter-2 (SGLT2) inhibitors, or dipeptidyl peptidase-4 (DPP4) inhibitor classes with other NIADs within those classes for the treatment of T2DM. The PubMed, Embase and Econlit databases were searched from 1 January 2018 to 15 November 2022. Two reviewers screened the studies for relevance by titles and abstracts and then for eligibility via full-text screening, extracted the data from the full texts and appendices, and then stored the data in a spreadsheet. RESULTS: The search yielded 890 records and 50 studies were eligible for inclusion. The studies were mainly based on a European setting (60%). Industry sponsorship was found in 82% of studies. The CORE diabetes model was used in 48% of the studies. GLP1 and SGLT2 products were the main comparators in 31 and 16 studies, respectively, while one study had DPP4 and two had no easily discernible main comparator. Direct comparison between SGLT2 and GLP1 occurred in 19 studies. At a class level, SGLT2 dominated GLP1 in six studies and was cost effective against GLP1 once as part of a treatment pathway. GLP1 was cost effective in nine studies and not cost effective against SGLT2 in three studies. At a product level, oral and injectable semaglutide, and empagliflozin, were cost effective against other within-class products. Injectable and oral semaglutide were more frequently found cost effective in these comparisons, with some conflicting results. Most of the modelled cohorts and treatment effects were sourced from randomised controlled trials. The following model assumptions varied depending on the class of the main comparator: choice of and reasoning behind risk equations, the time until the treatment switch, and how often the comparators were discontinued. Diabetes-related complications were emphasised on par with quality-adjusted life-years as model outputs. The main quality issues were regarding the description of alternatives, the perspective of analysis, the measurement of costs and consequences, and patient subgroups. CONCLUSION: The included CEAs using DAMs have limitations that hinder their ability to inform decision makers on the cost-effective choice: lack of updated reasoning behind the choice of key model assumptions, over-reliance on risk equations based on older treatment practices, and sponsorship bias. The question of which NIAD is cost effective for the treatment of which T2DM patient is a pressing one and the answer remains unclear.

Cost-effectiveness of targeted treatment vs chemoimmunotherapy in treatment-naive unfit CLL without TP53 aberrations.

Several targeted treatments, such as venetoclax + obinutuzumab (VenO) and ibrutinib, have been developed to treat patients with treatment-naive chronic lymphocytic leukemia (CLL) and have been shown to improve progression-free survival compared with chlorambucil + obinutuzumab (ClbO). However, novel targeted agents are associated with a significant cost investment. The objective of this study was to investigate the cost-effectiveness of VenO compared with ClbO and ibrutinib in treatment-naive CLL without del17p/TP53 mutation in Denmark. We used a decision-analytic modeling approach to simulate hypothetical cohorts of patients with CLL from the initiation of first-line treatment to death, including the full treatment pathway and second-line therapy. VenO, ClbO, or ibrutinib was included as first-line therapy followed by either Ven + rituximab or ibrutinib. Model outcomes were expected quality-adjusted life years (QALYs), life years (LYs), and cost per patient, which were used to calculate incremental cost-effectiveness ratios (ICERs) with a willingness to pay from €23 600 to €35 600 per QALY. Compared with ClbO, VenO was associated with a QALY gain of 1.30 (1.42 LYs) over a lifetime. The incremental cost was €12 360, resulting in an ICER of €9491 per QALY gained, indicating that VenO is cost-effective. Compared with VenO, ibrutinib was associated with a QALY gain of 0.82 (1.74 LYs) but at a substantially increased incremental cost of €247 488 over a lifetime horizon. The ICER was €302 156 per QALY, indicating that ibrutinib in first-line treatment would not be considered cost-effective in Danish health care, compared with VenO. Future analyses in fit patients with CLL are needed to determine the cost-effectiveness of VenO.

Healthcare Costs at the End of Life for Patients with Non-cancer Diseases and Cancer in Denmark.

OBJECTIVES: To examine costs of care from a healthcare sector perspective within 1 year before death in patients with non-cancer diseases and patients with cancer. METHODS: This nationwide registry-based study identified all Danish citizens dying from major non-cancer diseases or cancer in 2010-2016. Applying the cost-of-illness method, we included costs of somatic hospitals, including hospital-based specialist palliative care, primary care, prescription medicine and hospice expressed in 2022 euros. Costs of patients with non-cancer diseases and cancer were compared using regression analyses adjusting for sex, age, comorbidity, residential region, marital/cohabitation status and income level. RESULTS: Within 1 year before death, mean total healthcare costs were €27,185 [95% confidence interval (CI) €26,970-27,401] per patient with non-cancer disease (n = 109,723) and €51,348 (95% CI €51,098-51,597) per patient with cancer (n = 108,889). The adjusted relative total healthcare costs, i.e. the ratio of the mean costs, of patients with non-cancer diseases was 0.64 (95% CI 0.63-0.66) at 12 months before death and 0.91 (95% CI 0.90-0.92) within 30 days before death compared with patients with cancer. Mean costs of hospital-based specialist palliative care and hospice in the year leading up to death were €17 (95% CI €13-20) and €90 (95% CI €77-102) per patient with non-cancer disease but €1552 (95% CI €1506-1598) and €3411 (95% CI €3342-3480) per patient with cancer. CONCLUSIONS: Within 1 year before death, total healthcare costs, mainly driven by hospital costs, were substantially lower for patients with non-cancer diseases compared with patients with cancer. Moreover, the costs of hospital-based specialist palliative care and hospice were minimal for patients with non-cancer diseases.

Higher stroke unit volume associated with improved quality of early stroke care and reduced length of stay.

BACKGROUND AND PURPOSE: Specialized stroke unit care improves outcome among patients with stroke, but it is unclear whether there are any scale advantages in costs and clinical outcome from treating a larger number of patients. We examined whether the case volume in stroke units was associated with quality of early stroke care, mortality, and hospital bed-day use. METHODS: In a nationwide population-based cohort study, we identified 63 995 patients admitted to stroke units in Denmark between 2003 and 2009. Data on exposure, outcome, and covariates were collected prospectively. Comparisons were clustered within stroke units and adjusted for patient and hospital characteristics. RESULTS: Patients in high-volume stroke units overall had a better prognostic profile than patients in low-volume stroke units. Patients in high-volume stroke units also received more processes of care in the early phase of stroke compared with patients in low-volume stroke units (unadjusted difference, 9.84 percentage points; 95% CI, 3.98-15.70). High stroke unit volume was associated with shorter length of the initial hospital stay (adjusted ratio, 0.49; 95% CI, 0.41-0.59) and reduced bed-day use in the first year after stroke (adjusted ratio, 0.79; 95% CI, 0.70-0.87). No association between volume and mortality was found. CONCLUSIONS: Patients admitted to high-volume stroke units received a higher quality of early stroke care and spent fewer days in the hospital compared with patients in low-volume units. We observed no association between volume and mortality.

Competitive tenders on analogue hospital pharmaceuticals in Denmark 2017-2020.

BACKGROUND: Competitive tenders on pharmaceuticals are one of the most effective cost-containment instruments in healthcare systems. Its effectiveness has been demonstrated, among other things, in markets for generic medicine and biosimilars. In Denmark, an internationally unique model for competitive tenders on analogue substitutable pharmaceuticals has been developed and implemented for all public hospitals. METHODS: We obtained data on all analogue competitive tenders carried out by the Danish Medicines Council from its foundation on January 1, 2017, to October 9, 2020. We calculated univariate descriptive statistics, pairwise correlations and made a multiple regression analysis on tender savings. RESULTS: Average annual saving on hospital pharmaceutical purchase prices was 44.1% ranging from 0.4% to 92.8% between therapeutic areas and areas of indication. There was a significant positive correlation between tender savings and the number of competitors participating in the tender, and a significant negative correlation between tender savings and the number of days since market authorization. CONCLUSIONS: This study finds analogue tenders to be similar in effect and mechanism to competitive tenders in markets for generic medicine and biosimilars. It supports the increasing number of empirical findings that competitive tendering has a high potential to generate substantial savings on healthcare budgets.

The analogue substitution model: Introducing competition in the absence of generic substitution in Danish hospitals.

Increasingly advanced medicines have created monopolies in treatment areas with no viable options for generic substitution due to patent protection. As health care systems are increasingly under pressure to deliver health care improvements, costs become prohibitive as budgets are under pressure. To create financial flexibility, Danish regional authorities have over the period from 2009 until today developed, implemented, and gradually increased the use of a new model for analogue medicine substitution. The model introduces competitive tenders among patented medicines by declaring these medicines therapeutically equivalent in the treatment of specific diseases and thereby creating new opportunities for reducing annual medicine expenses. The model is based on enhanced collaboration among the health technology assessment (HTA) body, the procurement body, and the hospital owner, and it effectively covers medicine expenditure and cost-effectiveness while ensuring standardized treatments across hospitals and regions. The model is internationally unique in integrating several healthcare stakeholders and balancing their respective agendas to generate optimized outcomes for the healthcare system as a whole. However, some challenges persist, as the HTA process is resource and time consuming. Future research can show whether there are other challenges connected with the model.

Cost Effectiveness of Patient Self-Managed Warfarin Compared with Direct Oral Anticoagulants in Atrial Fibrillation: An Economic Evaluation in a Danish Healthcare Sector Setting.

BACKGROUND: Patient self-managed anticoagulant treatment with warfarin (PSM) has been proposed as an alternative to direct oral anticoagulants (DOACs) in patients with non-valvular atrial fibrillation (NVAF); however, direct evidence on the cost effectiveness of PSM compared with DOACs is lacking. We aimed to evaluate the cost effectiveness of PSM versus DOACs for NVAF patients in the Danish healthcare setting using a model-based cost-utility analysis. METHODS: A cost-utility analysis was performed using a decision-analytic model including two treatment alternatives: continuous PSM and DOACs. The analysis was performed from an extended Danish healthcare sector perspective, including patient-paid costs of medication related to the anticoagulant treatment, with a lifetime horizon. Inputs for the model comprised of probabilities of events, costs in Danish estimates, when possible, and effect in utilities. The probabilities of events are primarily based on real-life data from a direct comparison of PSM and DOACs. The results are presented as the incremental cost-effectiveness ratio (ICER) with an assumed cost-effectiveness threshold of £20,000/quality-adjusted life-year (QALY). Both deterministic and probabilistic sensitivity analyses were performed to investigate the robustness of the results. RESULTS: The base-analysis showed that PSM was dominant, with a decreased cost of £8495 and an increased QALY accumulation of 0.23 per patient (ICER = -£36,935/QALY). All deterministic sensitivity analyses indicated that PSM was dominant or at least cost effective. The probabilistic sensitivity analysis showed that 95% of the iterations were cost effective. CONCLUSIONS: The present study found that PSM is dominant (i.e., both more effective and cost saving) compared with DOACs, adding to the scarce evidence of the comparative cost effectiveness of PSM and DOACs in NVAF.

Quality of care and patient outcome in stroke units: is medical specialty of importance?

BACKGROUND: Specialized stroke unit care improves outcome in stroke patients. However, it is uncertain whether the units should be placed in a neurological or non-neurological (eg, internal medicine or geriatric) setting. OBJECTIVES: To assess whether stroke unit setting (neurological/non-neurological) is associated with quality of care and outcome among patients with stroke, and whether these associations depend on the severity of comorbidity. METHODS: In a nationwide population-based follow-up study, we identified 45,521 patients admitted to stroke units in Denmark between 2003 and 2008. Outcomes were quality of care (whether patients received evidence-based processes of acute stroke care), mortality, length of stay, and readmission. Charlson comorbidity index was used to assess comorbidity, and comparisons were adjusted for patient and hospital characteristics. RESULTS: Patients admitted to stroke units in neurological settings had higher odds for early antiplatelet therapy (odds ratio, 1.68; 95% confidence interval, 1.10-2.56) and early computed tomographic scan or magnetic resonance imaging (odds ratio, 1.77; 95% confidence interval, 1.29-2.45) compared with patients in non-neurological settings. No other differences were found when studying quality of care and patient outcomes. However, patients with moderate comorbidity admitted to stroke units in neurological settings had higher odds for 1-year mortality, but comparisons across strata of comorbidity were not statistical significant. CONCLUSIONS: Except for early antiplatelet therapy and early computed tomographic scan or magnetic resonance imaging, the medical setting was not associated with differences in processes of acute stroke care and patient outcome. No medical setting related differences were found according to comorbidity, although indications of a worse outcome in patients with moderate comorbidity in neurological settings warrant further investigation.

Health economic evaluations comparing faecal microbiota transplantation with antibiotics for treatment of recurrent Clostridioides difficile infection: a systematic review.

BACKGROUND: Faecal microbiota transplantation (FMT) is increasingly being used in the treatment of recurrent Clostridioides difficile infection (rCDI). Health economic evaluations may support decision-making regarding the implementation of FMT in clinical practice. Previous reviews have highlighted several methodological concerns in published health economic evaluations examining FMT. However, the impact of these concerns on the conclusions of the studies remains unclear. AIMS: To present an overview and assess the methodological quality of health economic evaluations that compare FMT with antibiotics for treatment of rCDI. Furthermore, we aimed to evaluate the degree to which any methodological concerns would affect conclusions about the cost-effectiveness of FMT. METHODS: We conducted a systematic literature review based on a search in seven medical databases up to 16 July 2020. We included research articles reporting on full health economic evaluations comparing FMT with antibiotic treatment for rCDI. General study characteristics and input estimates for costs, effectiveness and utilities were extracted from the articles. The quality of the studies was assessed by two authors using the Drummonds ten-point checklist. RESULTS: We identified seven cost-utility analyses. All studies applied decision-analytic modelling and compared various FMT delivery methods with vancomycin, fidaxomicin, metronidazole or a combination of vancomycin and bezlotoxumab. The time horizons used in the analyses varied from 78 days to lifelong, and the perspectives differed between a societal, a healthcare system or a third-party payer perspective. The applied willingness-to-pay threshold ranged from 20,000 to 68,000 Great Britain pound sterling (GBP) per quality-adjusted life-year (QALY). FMT was considered the most cost-effective alternative in all studies. In five of the health economic evaluations, FMT was both more effective and cost saving than antibiotic treatment alternatives. The quality of the articles varied, and we identified several methodological concerns. CONCLUSIONS: Economic evaluations consistently reported that FMT is a cost-effective and potentially cost-saving treatment for rCDI. Based on a comparison with recent evidence within the area, the multiple methodological concerns seem not to change this conclusion. Therefore, implementing FMT for rCDI in clinical practice should be strongly considered.

The Cost-Effectiveness of Empagliflozin Versus Liraglutide Treatment in People with Type 2 Diabetes and Established Cardiovascular Disease.

INTRODUCTION: The increasing financial burden associated with diabetes treatment presents a challenge to healthcare systems worldwide. Recently, clinical guidelines have focussed on patients with type 2 diabetes (T2D) and established cardiovascular disease (CVD) and recommend a sodium-glucose co-transporter 2 (SGLT2) inhibitor or a glucagon-like peptide 1 (GLP-1) receptor agonist as second-line treatment after metformin or independently of baseline glycated haemogloblin A1c (HbA1c). In Danish clinical guidelines, empagliflozin and liraglutide are highlighted owing to their positive impact on mortality. Thus, this study aimed to assess the cost-effectiveness of empagliflozin plus standard of care (SoC) versus liraglutide plus SoC in Danish patients with T2D and established CVD using a lifetime and 5-year horizon. METHODS: The IQVIA Core Diabetes Model (CDM) was calibrated to reproduce the clinical event rates observed in the cardiovascular outcome trial EMPA-REG OUTCOME. Network meta-analysis provided the relative risks for cardiovascular outcomes with empagliflozin versus liraglutide. Microvascular outcomes were predicted by standard CDM risk equations. The relative treatment effect was assumed for 9 years after which treatment was switched to basal-bolus therapy. The CDM was populated with Danish costs of events and drug costs at price-level 2019. Discounting of 4% was applied. RESULTS: Over a lifetime horizon, CDM projected 9.858 and 9.667 life years, 6.162 and 5.976 quality-adjusted life years (QALY) and DKK 478,026 (€64,079) and DKK 500,025 (€67,027) in total costs for empagliflozin plus SoC and liraglutide plus SoC, respectively. For a 5-year horizon, the results were 4.189 and 4.140 life years, 2.746 and 2.655 QALY, as well as DKK 123,413 (€16,543) and DKK 161,783 (€21,687), respectively. Empagliflozin was the dominant treatment alternative. Sensitivity analyses showed the robustness of these results. CONCLUSION: The cost-effectiveness analysis suggests that empagliflozin plus SoC is dominant compared to liraglutide plus SoC in Denmark over both lifetime and 5-year horizons.