The cost-effectiveness of home phototherapy for hyperbilirubinemia in neonates: results from a randomized controlled trial.

This study aimed to establish the cost-effectiveness of home phototherapy versus hospital phototherapy treating hyperbilirubinemia in neonates more than 36 weeks. Based on clinical results from a randomised controlled trial showing that home phototherapy for hyperbilirubinemia in term neonates is as effective as hospital phototherapy, we performed a cost-minimisation analysis to identify the most cost-effective alternative. We included costs for health care resource use as well as costs for transportation in connection with re-visits. The cost per patient was €337 for home phototherapy compared with €1156 for the hospital alternative indicating average cost savings of €819 (95% confidence interval €613-1025) or 71% per patient. Transportation and outpatient costs were higher in the home treatment group and hospital care costs were higher in the hospital group. Sensitivity analysis shows that results are robust also when allowing for uncertainty. Home phototherapy for neonates more than 36 weeks costs less than in-hospital phototherapy while being equally effective, meaning that home phototherapy is a cost-effective alternative to hospital treatment for infants with neonatal hyperbilirubinemia.Trial registration NCT03536078 . Date of registration: 24/05/2018.

Mapping the World Health Organization Disability Assessment Schedule (WHODAS 2.0) onto SF-6D Using Swedish General Population Data.

BACKGROUND AND OBJECTIVE: Mapping algorithms can be used for estimating quality-adjusted life years (QALYs) when studies apply non-preference-based instruments. In this study, we estimate a regression-based algorithm for mapping between the World Health Organization Disability Assessment Schedule (WHODAS 2.0) and the preference-based instrument SF-6D to obtain preference estimates usable in health economic evaluations. This was done separately for the working and non-working populations, as WHODAS 2.0 discriminates between these groups when estimating scores. METHODS: Using a dataset including 2258 participants from the general Swedish population, we estimated the statistical relationship between SF-6D and WHODAS 2.0. We applied three regression methods, i.e., ordinary least squares (OLS), generalized linear models (GLM), and Tobit, in mapping onto SF-6D from WHODAS 2.0 at the overall-score and domain levels. Root mean squared error (RMSE) and mean absolute error (MAE) were used for validation of the models; R2 was used to assess model fit. RESULTS: The best-performing models for both the working and non-working populations were GLM models with RMSE ranging from 0.084 to 0.088, MAE ranging from 0.068 to 0.071, and R2 ranging from 0.503 to 0.608. When mapping from the WHODAS 2.0 overall score, the preferred model also included sex for both the working and non-working populations. When mapping from the WHODAS 2.0 domain level, the preferred model for the working population included the domains mobility, household activities, work/study activities, and sex. For the non-working population, the domain-level model included the domains mobility, household activities, participation, and education. CONCLUSIONS: It is possible to apply the derived mapping algorithms for health economic evaluations in studies using WHODAS 2.0. As conceptual overlap is incomplete, we recommend using the domain-based algorithms over the overall score. Different algorithms must be applied depending on whether the population is working or non-working, due to the characteristics of WHODAS 2.0.

Cost-Effectiveness of Prolonged Physical Activity on Prescription in Previously Non-Complying Patients: Impact of Physical Activity Mediators.

In Sweden, physical activity on prescription (PAP) is used to support patients in increasing their levels of physical activity (PA). The role of healthcare professionals in supporting PA behavior change requires optimization in terms of knowledge, quality and organization. This study aims to evaluate the cost-effectiveness of support from a physiotherapist (PT) compared to continued PAP at a healthcare center (HCC) for patients who remained insufficiently active after 6-month PAP treatment at the HCC. The PT strategy was constituted by a higher follow-up frequency as well as by aerobic physical fitness tests. The analysis was based on an RCT with a three-year time horizon, including 190 patients aged 27-77 with metabolic risk factors. The cost per QALY for the PT strategy compared to the HCC strategy was USD 16,771 with a societal perspective (including individual PA expenses, production loss and time cost for exercise, as well as healthcare resource use) and USD 33,450 with a healthcare perspective (including only costs related to healthcare resource use). Assuming a willingness-to-pay of USD 57,000 for a QALY, the probability of cost-effectiveness for the PT strategy was 0.5 for the societal perspective and 0.6 for the healthcare perspective. Subgroup analyses on cost-effectiveness based on individual characteristics regarding enjoyment, expectations and confidence indicated potential in identifying cost-effective strategies based on mediating factors. However, this needs to be further explored. In conclusion, both PT and HCC interventions are similar from a cost-effectiveness perspective, indicating that both strategies are equally valuable in healthcare's range of treatments.

The Cost-Effectiveness of a Dance and Yoga Intervention for Girls with Functional Abdominal Pain Disorders.

BACKGROUND: Functional abdominal pain disorders (FAPDs) affect children worldwide, being more prevalent among girls. The individual and societal burdens of the disease are substantial, and evidence-based interventions are needed. Non-pharmacological treatments have generally produced promising results, with dance and yoga specifically having potential as an effective treatment option. Beside efficacy, the cost-effectiveness of interventions is important when prioritizing and allocating public resources. OBJECTIVE: This study evaluated the cost-effectiveness of an 8-month dance and yoga intervention for girls with functional abdominal pain or irritable bowel syndrome, based on a randomized control trial called 'Just in TIME'. METHODS: The intervention, performed in Sweden, was studied using a decision analysis tool, i.e., a decision tree within the trial followed by a Markov model with a time horizon of 10 years. The base case considered healthcare costs as well as productivity losses, measuring the effects in gained quality-adjusted life-years (QALYs) and presenting an incremental cost-effectiveness ratio (ICER). RESULTS: The base case results show that the intervention, compared with current practice, was the dominant strategy from both the 12-month and long-term perspectives. The sensitivity analyses indicated that the long-term, but not the short-term, findings were robust for different assumptions and changes in parameter estimates, resulting in ICERs similar to those of the base case scenario. CONCLUSIONS: Offering dance and yoga to young girls with FAPDs generates small QALY gains and monetary savings compared with standard healthcare and is likely cost-effective. These findings make a valuable contribution to an area where evidence-based and cost-effective treatment interventions are needed. CLINICAL TRIALS REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT02920268; Name: Just in TIME-Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain.

Effectiveness and costs of an implemented primary HPV cervical screening programme in Sweden - A population based cohort study.

Swedish guidelines recommend cervical screening with primary HPV for women ≥ 30 years of age. The aim of this study was to compare an implemented HPV cervical screening programme in the Region of Örebro County from September 1, 2016, with the former cytology-based screening programme. The clinical effectiveness by means of number of high-grade squamous intraepithelial lesions (HSILs) and cervical cancer cases detected in histology within 12 months after the screening test, together with cost implications were the main outcomes. Data were retrieved from the Swedish National Cervical Screening Registry between the years 2014-2015 (cytology based screening) and 2017-2018(HPV based screening), including screening information such as invitations and cytology and histology diagnoses. The detection rate of HSIL + among women ≥ 30 years of age was 1.2 times higher with HPV screening, but data revealed an increase in direct colposcopy referral rate by 54% and a higher percentage of irrelevant findings (≤LSIL). Screening based on HPV for women ≥ 30 has increased yearly cost from 1 to 1.3 million EUR, while increasing the number of HSIL + identified. Two thirds of the total costs are from visits for screening samples in the programme. HPV screening detected more cases of HSIL + compared to cytology screening among women ≥ 30 although high colposcopy rate, high rate of clinical irrelevant findings and higher costs were shown in the HPV-based screening programme, which implies that alterations in the screening programme in the future are important to consider.

Open and closed surgical exposure of palatally displaced canines: a cost-minimization analysis of a multicentre, randomized controlled trial.

OBJECTIVE: To evaluate the costs of open and closed surgical exposure and subsequent orthodontic treatment for the correction of palatally displaced canines (PDCs). TRIAL DESIGN: A multicentre, two-arm parallel group randomized controlled trial. METHODS: One hundred twenty adolescents between 9 and 16 years of age, from three orthodontic specialist centres, were randomized to one of the two surgical exposure interventions. The randomization was conducted according to a two-arm parallel group 1:1 allocation ratio, using computerized lists with block randomization. In both the surgical techniques, whole mucoperiosteal flaps were raised, and bone covering the PDCs was removed. In the open technique, glass ionomer was built up on the PDC crown - reaching above the mucosa through a hole punched in the flap - to allow the canine to erupt autonomously. After eruption, the canine was orthodontically moved above the mucosa. In the closed technique, an eyelet was bonded onto the PDC, the flap was repositioned and the canine was orthodontically moved beyond the mucosa. The trial ended when the PDC was successfully aligned in the dental arch.Cost analysis was performed including costs for surgery, orthodontic treatment, emergency visits, and material, as well as costs for transports and time spent in connection with every appointment. BLINDING: Patients and caregivers could not be blinded due to obvious limitations of the clinical setting, while outcome assessors and data analysts were blinded. RESULTS: A cost-minimization analysis was performed since both exposure groups succeeded equally well in terms of treatment effects. The two different surgical exposures and following orthodontic treatments did not differ significantly in terms of costs. GENERALIZABILITY AND LIMITATIONS: Costs are estimated in the Swedish setting, which needs to be considered if applying the results in other settings. Calculations of total cost do not include finishing, debonding, retention, and follow-up. CONCLUSION: There is no significant difference in costs between closed and open surgical exposure with following orthodontic treatments in PDCs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02186548.

Changing diagnostic criteria for gestational diabetes in Sweden - a stepped wedge national cluster randomised controlled trial - the CDC4G study protocol.

BACKGROUND: The optimal criteria to diagnose gestational diabetes mellitus (GDM) remain contested. The Swedish National Board of Health introduced the 2013 WHO criteria in 2015 as a recommendation for initiation of treatment for hyperglycaemia during pregnancy. With variation in GDM screening and diagnostic practice across the country, it was agreed that the shift to new guidelines should be in a scientific and structured way. The aim of the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) in Sweden ( www.cdc4g.se/en ) is to evaluate the clinical and health economic impacts of changing diagnostic criteria for GDM in Sweden and to create a prospective cohort to compare the many long-term outcomes in mother and baby under the old and new diagnostic approaches. METHODS: This is a stepped wedge cluster randomised controlled trial, comparing pregnancy outcomes before and after the switch in GDM criteria across 11 centres in a randomised manner. The trial includes all pregnant women screened for GDM across the participating centres during January-December 2018, approximately two thirds of all pregnancies in Sweden in a year. Women with pre-existing diabetes will be excluded. Data will be collected through the national Swedish Pregnancy register and for follow up studies other health registers will be included. DISCUSSION: The stepped wedge RCT was chosen to be the best study design for evaluating the shift from old to new diagnostic criteria of GDM in Sweden. The national quality registers provide data on the whole pregnant population and gives a possibility for follow up studies of both mother and child. The health economic analysis from the study will give a solid evidence base for future changes in order to improve immediate pregnancy, as well as long term, outcomes for mother and child. TRIAL REGISTRATION: CDC4G is listed on the ISRCTN registry with study ID ISRCTN41918550 (15/12/2017).

From loss of life to loss of years: a different view on the burden of injury fatalities in Sweden 1972-2014.

Background: Worldwide, about 5.8 million people die each year due to injuries. In Sweden, the corresponding number amounts to 3000. There are large differences among injury types regarding the age-profile of the fatalities and as most of them occur in older age groups, counting the absolute number of injury fatalities does not fully reflect the size of the burden of injury. Methods: Using age- and sex-specific life expectancy tables in combination with data on external causes of injury, the number of injury fatalities in Sweden for the time period 1972-2014 is converted to a sum of potential years of life lost (PYLL). We then fit cause and group-specific spline regression models to the data to estimate temporal trends in both fatality counts and PYLL. Results: There has been a steady reduction in the number of injury fatalities and in the sum of PYLL from the early 1970s to around the year 2000. Since then, there has been an increase in the number of injury fatalities and in the sum of PYLL. The upward trend is mainly explained by an increasing number of deaths due to poisonings and suicide, specifically among younger men. Conclusions: The increases in suicide and poisoning mortality offset the reductions in downward trending causes of injury mortality during the last decades. The share of PYLL is larger than the share of fatalities for both suicides and poisonings implying that an aging population does not cause the increase.

Modelling the cost-effectiveness of impact-absorbing flooring in Swedish residential care facilities.

OBJECTIVE: Fall-related injuries among the elderly, specifically hip fractures, cause significant morbidity and mortality as well as imposing a substantial financial cost on the health care system. Impact-absorbing flooring has been advocated as an effective method for preventing hip fractures resulting from falls. This study identifies the cost-effectiveness of impact-absorbing flooring compared to standard flooring in residential care facilities for the elderly in a Swedish setting. METHOD: An incremental cost-effectiveness analysis was performed comparing impact-absorbing flooring to standard flooring using a Markov decision model. A societal perspective was adopted and incremental costs were compared to incremental gains in quality-adjusted life years (QALYs). Data on costs, probability transitions and health-related quality of life measures were retrieved from the published literature and from Swedish register data. Probabilistic sensitivity analysis was performed through a Monte Carlo simulation. RESULTS: The base-case analysis indicates that the impact-absorbing flooring reduces costs and increases QALYs. When allowing for uncertainty we find that 60% of the simulations indicate that impact-absorbing flooring is cost-saving compared to standard flooring and an additional 20% that it has a cost per QALY below a commonly used threshold value CONCLUSIONS: : Using a modelling approach, we find that impact-absorbing flooring is a dominant strategy at the societal level considering that it can save resources and improve health in a vulnerable population.

The Willingness to Pay for a Quality Adjusted Life Year: A Review of the Empirical Literature.

There has been a rapid increase in the use of cost-effectiveness analysis, with quality adjusted life years (QALYs) as an outcome measure, in evaluating both medical technologies and public health interventions. Alongside, there is a growing literature on the monetary value of a QALY based on estimates of the willingness to pay (WTP). This paper conducts a review of the literature on the WTP for a QALY. In total, 24 studies containing 383 unique estimates of the WTP for a QALY are identified. Trimmed mean and median estimates amount to 74,159 and 24,226 Euros (2010 price level), respectively. In regression analyses, the results indicate that the WTP for a QALY is significantly higher if the QALY gain comes from life extension rather than quality of life improvements. The results also show that the WTP for a QALY is dependent on the size of the QALY gain valued. Copyright © 2014 John Wiley & Sons, Ltd.

Are national injury prevention and research efforts matching the distribution of injuries across sectors?

In 2011, 88% of all unintentional injury fatalities occurred in home and leisure environments in Sweden, while transportation fatalities accounted for 10% and work/school injuries for 2%. The corresponding proportions among non-fatal injuries were 75, 12 and 13%, respectively. However, 83% of the national governmental expenditure on unintentional injury prevention in 2011 was allocated to transportation safety, 7% to home and leisure, and 10% to the work sector including schools. Likewise, around 85% of the governmental research budget aimed for unintentional injury research was allocated to the transportation sector, 9% to home and leisure environments, and 6% to the work and school sector. Our results reveal a striking lack of correspondence between problem profile and governmental countermeasures.

Is Sweden still a role model for safety? An overview of unintentional injury data over the past two decades.

This study investigates injury-related mortality and hospitalisations, during 1987-2007 in Sweden. Injuries were classified according to International Classification of Diseases (ICD)--8 for pre-1987 injuries, ICD-9 for 1987-1996 injuries and ICD-10 for injuries occurring in 1997 and later. Data on mortality from injuries during 1987-2007 were collected from Sweden's national Cause-of-Death Register, while data concerning injury diagnoses leading to hospitalisation stays of at least 24 h, occurring during 1987-2007, were obtained from the national Patient Register. Crude rates were derived for injury-related deaths and injury-related hospitalisations for age-gender groups, using population data from Statistics Sweden. Our results showed a mixed picture of injury-related hospitalisations and deaths over the study period. Absolute numbers of injury-related deaths and injury-related hospitalisations decreased over time for the population as a whole and for many, but not all, age-gender groups. When assessing crude injury-related death rates and crude injury-related hospitalisation rates over time, as categorised by gender and age groupings, we also found unchanging or increased risks for injury-related deaths and/or hospitalisations for several age-gender groups. While Sweden has made remarkable progress in reducing injury-related deaths and hospitalisations, there are clear differences in risk that remain.

Effectiveness of community-based injury prevention. Long-term injury rate levels, changes, and trends for 14 Swedish WHO-designated Safe Communities.

This study investigates the injury rate levels, changes, and trends between 1987 and 2002 for the 14 Swedish municipalities designated as WHO Safe Communities. The injury rate was defined as the number of injured patients discharged from hospital per 1000 persons. Injury rates were age standardised. Each municipality was compared with its respective municipality group, according to a classification of Sweden's 288 municipalities into nine groups based on numerous structural parameters. The average injury rate levels for the 14 WHO-designated Safe Community municipalities ranged from 11.54 to 19.09 per 1000 population during the study period, which was defined as the time period during which a municipality's injury prevention program has been operational. Eleven of 14 municipalities had higher levels than their corresponding municipality groups. Five of the 14 municipalities "outperformed" their respective municipality groups and achieved a greater relative injury rate decrease during the study period. The trends for the 14 municipalities in relation to their municipality groups showed an inconsistent pattern, with only four municipalities exhibiting overall favourable trends for the study period.