Can our experience with surveillance for inherited pancreatic cancer help to identify early pancreatic cancer in the general population?

Screening of the general population for cancer is a matter of primary prevention reducing the burden of disease. Whilst this is successful for several cancers including breast, colon and prostate, the situation to screen and hence prevent pancreatic cancer is different. The organ is not as accessible to simple physical exam or biological samples (fecal or blood test). Neither exists a blood test such as PSA that is cost-effective. Reviewing the evidence from screening risk groups for pancreatic cancer, one must conclude that there is no rational at present to screen the general population, for a lack of appropriate tests.

Validation of overall survival extrapolations made by TLV in the assessment of cost-effectiveness of oncology drugs in Sweden - A pilot study comparing extrapolated and observed life-years gained.

AIM: The aim of the study is to assess the accuracy of overall survival (OS) extrapolations in cost-effectiveness analysis made by the Dental and Pharmaceutical Benefits Agency (TLV) to decide on the reimbursement and use of oncology drugs in Sweden. MATERIAL AND METHODS: TLV appraisals for oncology drugs were identified during a 5-year period (2013-2017). To be included each appraisal and health economic model must include a TLV base case extrapolation of OS. Further, Kaplan-Meier (KM) estimates on OS from the original and follow-up clinical trials must be available. Potential follow-up trials on OS were identified in ClinicalTrials.gov and the Lund University Libraries databases, and in the Swedish Medical Products Agency (MPA) and the European Medicines Agency (EMA) databases. In cases where the KM estimates were not available, data points from figures published in TLV's appraisals were extracted using the semi-automated tools Digitizelt and WebPlotDigitizer. The accuracy of survival extrapolations was assessed by comparing extrapolated and observed life-years (LYs), using three different measures: 1) difference in LYs between the treatment and control group; 2) LYs in the treatment group, 3) LYs in the control group. RESULTS: We study TLV's preferred OS extrapolations and show that on average they overestimate the observed mean gain in LYs by 24%, and underestimate observed LYs by 3% and 11% in the treatment and control group, respectively. CONCLUSIONS: We conclude that it is feasible to validate OS extrapolations by comparing extrapolated and observed life-years. Even if survival extrapolations are reasonably accurate for the treatment group, this may still imply that extrapolations of LYs gained deviates to a larger extent. Follow-up studies on OS should be carried out to an increased extent to be able to validate, update and improve OS extrapolations in cost-effectiveness analysis of oncology drugs.

Association between pulse width and health-related quality of life after electroconvulsive therapy in patients with unipolar or bipolar depression: an observational register-based study.

AIMS: To examine the association between pulse width and HRQoL measured within one week after electroconvulsive therapy (ECT) and at six-month follow-up in patients with unipolar or bipolar depression. METHODS: This was an observational register study using data from the Swedish National Quality Registry for ECT (2011-2019). Inclusion criteria were: age ≥18 years; index treatment for unipolar/bipolar depression; unilateral electrode placement; information on pulse width; EQ-5D measurements before and after ECT. Multiple linear regressions were performed to investigate the association between pulse width (<0.5 ms; 0.5 ms; >0.5 ms) and HRQoL (EQ-5D-3L index; EQ VAS) one week after ECT (primary outcome) and six months after ECT (secondary outcome). RESULTS: The sample included 5,046 patients with unipolar (82%) or bipolar (18%) depression. At first ECT session, 741 patients (14.7%) had pulse width <0.5 ms, 3,639 (72.1%) had 0.5 ms, and 666 (13.2%) had >0.5 ms. There were no statistically significant associations between pulse width and HRQoL one week after ECT. In the subsample of patients with an EQ-5D index recorded six months after ECT (n = 730), patients receiving 0.5 ms had significantly lower HRQoL (-0.089) compared to <0.5 ms, after adjusting for demographic and clinical characteristics (p = .011). The corresponding analysis for EQ VAS did not show any statistically significant associations. CONCLUSION: No robust associations were observed between pulse width and HRQoL after ECT. On average, significant improvements in HRQoL were observed one week and six months after ECT for patients with unipolar or bipolar disease, independent of the pulse width received.

Real-world outcomes in spinal cord stimulation: predictors of reported effect and explantation using a comprehensive registry-based approach.

Introduction: Despite advancements in implanted hardware and development of novel stimulation paradigms in Spinal Cord Stimulation (SCS), real world evidence suggests a large variation in patient reported outcomes and a proportion of patients are later explanted due to loss of analgesia. Possible predictors for outcome have been explored in smaller short-term evaluations, but few clinically applicable robust measures for long term outcome have emerged. Methods: We performed a comprehensive retrospective study based on an assembled patient-level aggregated database from multiple local and national registries in Sweden. Variables associated with risk of explantation (due to insufficient analgesia) and analgesic effect was analyzed using a Cox regression analysis and an ordered logit regression model, respectively. Results: We found the accumulated risk of explantation due to loss of analgesia to be 10% and 21% at two and ten years follow up, respectively. The use of 10 kHz spinal cord stimulation (compared with Tonic waveform; p = 0.003), and being 60 years or older (reference 18-40 years; p = 0.003) were associated with an increased risk of explantation.At a mean follow up at 1 year, 48% of patients reported a pain intensity reduction from baseline of at least 30%. Secondary (p = 0.030) and post-secondary (p = 0.001) education (compared with primary education) was associated with an increased probability of successful patient reported outcomes. Conclusion: This study suggests that a higher educational level and being employed are associated with successful treatment outcome in patients with chronic pain treated with SCS in Sweden.

Impact of spinal cord stimulation on sick leave and disability pension in patients with chronic neuropathic pain: a real-world evidence study in Sweden.

ABSTRACT: Current research indicates that spinal cord stimulation (SCS) has a positive short-term impact on outcomes, such as quality of life, pain, and productivity in patients with chronic neuropathic pain. However, there is a need for studies on larger population samples. This study used data from Swedish national registers to analyze change and predictors of sick leave and disability pension 2 years before and after SCS treatment. Patients with SCS implanted between 2006 and 2017, and a reference group consisting of 5 individuals matched to each SCS patient without replacement with respect to age, sex, and region of residence, were included. A difference-in-difference approach was used to compare the average change (2 years after treatment vs 2 years before treatment) in net disability days and indirect cost related to disability days for the SCS group, compared with the average change for the reference group. The results showed that SCS treatment in Sweden is associated with a decrease of 21 disability days and consequent decrease in indirect cost of €4127 in working age patients. Large work loss prior to index date was also demonstrated (average 214 days before 1 year), indicating a significant burden on the patient, employers, and the society at large. The number of disability days varied considerably depending on age, sex, socioeconomic variables, and comorbidities; however, the effect of SCS seemed to have little association with patient characteristics. This economic benefit needs to be considered, as well as the clinical outcome, when evaluating the full societal value of SCS.

Health-related quality of life in patients with lower limb amputation - an assessment of the measurement properties of EQ-5D-3L and EQ-5D-5L using data from the Swedish Amputation and Prosthetics Registry.

PURPOSE: To assess the measurement properties of EQ-5D-3L and EQ-5D-5L in patients with a major lower limb amputation (LLA). METHODS: This was a retrospective register-based study using data from the Swedish Amputation and Prosthetics Registry (SwedeAmp). Patients with a six-months follow-up (including either EQ-5D-3L or EQ-5D-5L) after a major unilateral LLA were included. The measurement properties of EQ-5D-3L and EQ-5D-5L were compared in terms of feasibility, response patterns, informativity, and convergent and known-group validity. RESULTS: The sample included 700 patients with below-knee amputation (76%), above-knee amputation (18%), or knee disarticulation (7%). Responses to EQ-5D-3L and -5L were similar regarding feasibility (98% completion rate) and the proportion reporting no problems (7% and 6%). Compared to EQ-5D-3L, EQ-5D-5L showed higher absolute and relative informativity in all dimensions, with the largest improvement in the mobility dimension. In the analyses of convergent validity, the EQ-5D-5L generally showed stronger correlations with disease-specific measures. Only EQ-5D-5L was able to discriminate between subgroups with different amputation levels. CONCLUSION: The findings support the use of EQ-5D-5L over EQ-5D-3L in patients with an LLA, mainly due to improved informativity and improved convergent and known-group validity.Implications for rehabilitationThe measurement properties of two EQ-5D versions, EQ-5D-3L and EQ-5D-5L, has so far not been evaluated in patients with a lower limb amputation (LLA)The results support the use of EQ-5D-5L over the use of EQ-5D-3L, mainly due to improved informativity and stronger correlations with disease-specific patient-reported outcome measuresThe five-level version of EQ-5D is recommended for future applications of EQ-5D in clinical outcome studies, health economic evaluations, and in the routine follow-up of patients with a major LLAIn the early rehabilitation process six months after an LLA, the majority of patients reported problems with mobility, pain/discomfort, and usual activities.

Health care costs associated with clinic visits for prevention of mother-to-child transmission of HIV in Dar es Salaam, Tanzania.

ABSTRACT: Early and appropriate antenatal care (ANC) is key for the effectiveness of prevention of mother-to-child transmission (PMTCT) of human immunodeficiency virus (HIV). We evaluated the importance of ANC visits and related service costs for women receiving option B+ to prevent mother-to-child transmission (MTCT) of HIV in Tanzania.A cost analysis from a health care sector perspective was conducted using routine data of 2224 pregnant women newly diagnosed with HIV who gave birth between August 2014 and May 2016 in Dar es Salaam, Tanzania. We evaluated risk of infant HIV infection at 12 weeks postnatally in relation to ANC visits (<4 vs ≥4 visits). Costs for service utilisation were estimated through empirical observations and the World Health Organisation Global Price Reporting Mechanism.Mean gestational age at first ANC visit was 22 (±7) weeks. The average number of ANC/prevention of MTCT visits among the 2224 pregnant women in our sample was 3.6 (95% confidence interval [CI] 3.6-3.7), and 57.3% made ≥4 visits. At 12 weeks postnatally, 2.7% (95% CI 2.2-3.6) of HIV exposed infants had been infected. The risk of MTCT decreased with the number of ANC visits: 4.8% (95% CI 3.6-6.4) if the mother had <4 visits, and 1.0% (95% CI 0.5-1.7) at ≥4. The adjusted MTCT rates decreased by 51% (odds ratio 0.49, 95% CI 0.31-0.77) for each additional ANC visit made. The potential cost-saving was 2.2 US$ per woman at ≥4 visits (84.8 US$) compared to <4 visits (87.0 US$), mainly due to less defaulter tracing.Most pregnant women living with HIV in Dar es Salaam initiated ANC late and >40% failed to adhere to the recommended minimum of 4 visits. Improved ANC attendance would likely lead to fewer HIV-infected infants and reduce both short and long-term health care costs due to less spending on defaulter tracing and future treatment costs for the children.

Observational study of the implementation of telephone advice nursing in Sweden: did callers follow recommendations and did the rate of healthcare visits change?

OBJECTIVES: Telephone advice nursing is introduced in many countries with one key aim being a reduction of avoidable healthcare visits. The aim of this study was to explore whether callers to a telephone advice nursing service followed the telenurses' recommendations, and whether there was a change in the level and trend of the rate of healthcare visits after the introduction of telephone advice nursing. DESIGN: Observational study. SETTING: Primary and secondary care in Jönköping Region, Sweden. PARTICIPANTS: Telephone advice nursing calls, 6:00-23:00, 2014-2015 (n=185 994) and outpatient healthcare visits 2012-2015 (n=6 877 266). PRIMARY OUTCOME: Proportion of callers who visited healthcare within the time period advised by the telenurse. SECONDARY OUTCOME: Change in level or trend of the overall rate of healthcare visits per 1000 persons and 4-week period after the introduction of telephone advice nursing, with subgroup analysis for primary and secondary care. RESULTS: 77% of callers who were recommended either to visit healthcare within 24 hours or to 'wait and see' followed the recommendations. There was no significant change in level (-5.15; 95% CI -15.80 to 5.50; p=0.349) or trend (-0.24; 95% CI -0.86 to 0.38; p=0.448) of the overall rate of visits per 1000 persons and 4-week period after the introduction of telephone advice nursing. For the rate of primary care visits, an increase in level (8.01; 95% CI 6.36 to 9.66; p<0.001) and trend (1.28; 95% CI 1.17 to 1.39; p<0.001) were observed. For the rate of secondary care visits, a decrease in level (-8.77, 95% CI -14.41 to -3.13; p=0.004) and trend (-1.03, 95% CI -1.35 to -0.71; p<0.001) were observed. CONCLUSIONS: The introduction of telephone advice nursing may have contributed to a shift in the rate of healthcare visits from secondary to primary care.

Productivity losses among people with back pain and among population-based references: a register-based study in Sweden.

OBJECTIVE: Back pain is the leading cause for years lived with disability globally and among the main reasons for sickness absence (SA) and disability pension (DP). The objective of this study was to explore the occurrence of SA and DP and to estimate productivity losses among individuals with back pain compared with among matched population-based references. DESIGN: Explorative prospective cohort study using register microdata. PARTICIPANTS AND SETTING: A total of 23 176 people, aged 19-60 years, with a first visit to inpatient or specialised outpatient healthcare for back pain (International Statistical Classification of Diseases and Related Health Problems code M54) in 2010 in Sweden and a matched population-based reference group (n=115 880). OUTCOMES: Long-term SA (in SA spells >14 days) and DP and productivity losses, measured in € (2018 prices) by multiplying the SA and DP net days by the societal cost of each such day. RESULTS: In the back-pain group, 42% had SA or DP days; in the reference group, the corresponding proportion was 15%. Productivity loss per patient with back pain was €8928 during the 12-month follow-up period; in the reference group, it was €3499 (p<0.0001). CONCLUSIONS: SA and DP, leading to excess productivity losses among people with back pain, reflect the challenges these patients are facing to maintain their work capacity. Interventions to promote that individuals with back pain remain in paid work should be a priority in order to address the high costs.

Economic Costs of Myasthenia Gravis: A Systematic Review.

OBJECTIVES: The objective of our study was to conduct a systematic literature review of economic costs (henceforth costs) associated with myasthenia gravis (MG). METHODS: We searched MEDLINE (through PubMed), CINAHL, Embase, PsycINFO, and Web of Science for studies reporting costs of MG published from inception up until March 18, 2020, without language restrictions. Two reviewers independently screened records for eligibility, extracted the data, and assessed included studies for risk of bias using the Newcastle-Ottawa Scale. Costs were inflated and converted to 2018 United States dollars ($). RESULTS: The search identified 16 articles for data extraction and synthesis. Estimates of costs of MG were found for samples from eight countries spanning four continents (Europe, North America, South America, and Asia). Across studies, the mean per-patient annual direct medical cost of illness was estimated at between $760 and $28,780, and cost per hospitalization between $2550 and $164,730. The indirect cost of illness was estimated at $80 and $3550. Costs varied considerably by patient characteristics, and drivers of the direct medical cost of illness included intravenous immunoglobulin and plasma exchange, myasthenic crisis, mechanical ventilatory support, and hospitalizations. CONCLUSIONS: We show that the current body of literature of costs of MG is sparse, limited to a few geographical settings and resource categories, mostly dated, and subject to non-trivial variability, both within and between countries. Our synthesis will help researchers and decision-makers identify gaps in the local health economic context of MG and inform future cost studies and economic evaluations in this patient population.

The digit ratio (2D:4D) and economic preferences: no robust associations in a sample of 330 women.

Many studies report on the association between 2D:4D, a putative marker for prenatal testosterone exposure, and economic preferences. However, most of these studies have limited sample sizes and test multiple hypotheses (without preregistration). In this study we mainly replicate the common specifications found in the literature for the association between the 2D:4D ratio and risk taking, the willingness to compete, and dictator game giving separately. In a sample of 330 women we find no robust associations between any of these economic preferences and 2D:4D. We find no evidence of a statistically significant relation for 16 of the 18 total regressions we run. The two regression specifications which are statistically significant have not previously been reported and the associations are not in the expected direction, and therefore they are unlikely to represent a real effect.

Standardized Questionnaire for the Measurement, Valuation, and Estimation of Costs of Informal Care Based on the Opportunity Cost and Proxy Good Method.

Costs of informal care account for a significant component of total societal costs for many chronic and disabling illnesses. Yet, costs associated with the provision of informal care is seldom included in economic evaluations of new health technologies, increasing the risk of suboptimal decisions on the allocation of resources from the perspective of society. Our objective was to propose a standardized questionnaire for the measurement, valuation, and estimation of caregiver indirect (productivity) and informal care costs as separate mutually exclusive subsets of total costs in cost-of-illness studies and as an input to economic evaluations from the societal perspective. We developed a questionnaire for data collection and step-by-step analysis procedures for resource valuation and cost estimation. Data concerning absenteeism from work and time devoted to informal care were recorded using the recall method. Indirect (productivity) and paid informal care costs were valued and estimated according to the human-capital approach as the loss of production. Unpaid informal care costs were valued and estimated as the loss of leisure time quantified using the opportunity cost and proxy good method. The new questionnaire, titled the Caregiver Indirect and Informal Care Cost Assessment Questionnaire, contains 13 questions regarding caregiver current and previous work status, productivity, and the provision of informal care (stratified by time devoted to household activities, personal care, practical support, and emotional support). The proposed questionnaire should be helpful to inform the design, implementation, and execution of future cost-of-illness studies and economic evaluations from the perspective of society.

Cost-effectiveness of an adherence-enhancing intervention for gout based on real-world data.

AIM: Medication non-adherence influences outcomes of therapies for chronic diseases. Allopurinol is a cornerstone therapy for patients with gout; however, non-adherence to allopurinol is prevalent in Singapore and limits its effectiveness. Between 2008-2010, an adherence-enhancing program was implemented at the rheumatology division of a public tertiary hospital. The cost-effectiveness of this program has not been fully evaluated. With healthcare resources being finite, the value of investing in adherence-enhancing interventions should be ascertained. This study aims to evaluate the cost-effectiveness of this adherence-enhancing program to inform optimal resource allocation toward better gout management. METHOD: Adopting a real-world data approach, we utilized patient clinical and financial records generated in their course of routine care. Intervention and control groups were identified in a standing database and matched on nine risk factors through propensity score matching. Cost and effect data were followed through 1-2 years. A decision tree was developed in TreeAge using a societal perspective. Deterministic and probabilistic sensitivity analyses were performed to assess parameter uncertainty. RESULTS: At an assumed willingness-to-pay threshold of $50 000 USD ($70 000 SGD) per quality-adjusted life year (QALY), the intervention had an 85% probability of being cost-effective compared to routine care. The incremental cost-effectiveness ratio was $12 866 USD per QALY for the base case and ranged from $4 139 to $21 593 USD per QALY in sensitivity analyses. CONCLUSION: The intervention is cost-effective in the short-term, although its long-term cost-effectiveness remains to be evaluated.

Economic Evaluation of PRIMROSE-A Trial-Based Analysis of an Early Childhood Intervention to Prevent Obesity.

BACKGROUND: Childhood obesity is a major clinical and economic health concern. Alongside the clinical understanding of obesity, there is a growing interest in designing and implementing interventions that are worth their money given the scarce resources in the health care sector. This study is one of the first efforts to provide evidence by assessing the effects and costs of a population-based primary prevention intervention targeting pre-school children attending child health centers in Sweden. METHODS: The economic evaluation is based on the PRIMROSE cluster-randomized controlled trial aiming to establish healthy eating and physical activity among pre-school children (9-48 months of age) through motivational interviewing applied by trained nurses at child health centers. The cost-effectiveness is assessed over the trial period from a societal perspective. The primary outcome was BMI at age 4. Cost data was prospectively collected alongside the trial. Scenario analyses were carried out to identify uncertainty. RESULTS: The estimated additional mean total costs of the PRIMROSE intervention were 342 Euro (95% CI: 334; 348) per child. During pre-school years direct costs mainly consist of training costs and costs for the additional time used by nurses to implement the intervention compared to usual care. Early indirect costs mainly consist of parents' absence from work due to their participation in the intervention. The incremental cost-effectiveness ratio in the base case analysis was 3,109 Euro per 1 BMI unit prevented. CONCLUSION: We cannot provide evidence that the PRIMROSE intervention is cost-effective, given the uncertainty in the effect measure. Until further evidence is provided, we recommend resources to be spent elsewhere within the field of obesity prevention. Furthermore, to achieve valid and reliable cost-effectiveness results, the economic evaluation of obesity prevention programs in early childhood should incorporate the life time impact to capture all relevant costs and benefits.

Effectiveness, costs and cost-effectiveness of chiropractic care and physiotherapy compared with information and advice in the treatment of non-specific chronic low back pain: study protocol for a randomised controlled trial.

BACKGROUND: Low back pain is a global public health problem and a leading cause of disability all over the world. The lifetime prevalence of low back pain is 70-80% and a significant proportion of people affected develop chronic low back pain (CLBP). Besides a severe negative impact on people's health and health-related quality of life, CLBP is associated with substantial costs for society. Medical costs for the management of CLBP and costs for production losses due to absenteeism from work are sizeable. Pharmaceuticals, physical activity, manipulation, and multidisciplinary rehabilitation interventions are examples of widely used treatments for CLBP. However, the scientific basis to recommend the use of one treatment over another is limited and more research is needed to study the effects, costs and cost-effectiveness of treatments for CLBP in clinical practice. The aim of the study is to evaluate the effectiveness (back pain-related functional limitation, back pain intensity, general health, health-related quality of life, and working status), costs (medical costs and costs for production losses) and cost-effectiveness of chiropractic care and physiotherapy when added to information and advice in the treatment of patients with non-specific CLBP in Sweden. METHODS/DESIGN: This is a pragmatic randomised controlled trial, where participants are recruited through six primary care rehabilitation units (PCRUs) in Stockholm County Council, Sweden. Individuals with non-specific CLBP are individually randomised to one of four treatment groups: 'information and advice'; 'physiotherapy, and information and advice'; 'chiropractic care, and information and advice'; or 'chiropractic care, physiotherapy, and information and advice'. A sample size of 600 participants will be recruited during a period of 33 months. A computer-based questionnaire is used to collect data on back pain-related functional limitation (Oswestry Disability Index), pain intensity (Numeric Rating Scale), general health (self-rated health), health-related quality of life (EQ-5D-3L), and working status (measured as percentage of full-time work). Data will be collected at baseline, and at 3, 6, and 12 months after baseline. DISCUSSION: The results from our study should be considered when producing evidence-based guidelines and recommendations on which treatment strategies to use for CLBP. TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN15830360 . Registered prospectively on 2 February 2017.

A first-choice combined oral contraceptive influences general well-being in healthy women: a double-blind, randomized, placebo-controlled trial.

OBJECTIVE: To determine whether there is a causal effect of oral contraceptive (OC) treatment on general well-being and depressed mood in healthy women. DESIGN: Double-blind, randomized, and placebo-controlled trial. SETTING: University hospital. PATIENT(S): Three hundred and forty healthy women aged 18-35 years randomized to treatment, of whom 332 completed the data collection at follow-up evaluation. INTERVENTION(S): A combined OC (150 µg levonorgestrel and 30 µg ethinylestradiol) or placebo for 3 months of treatment. MAIN OUTCOME MEASURE(S): Primary outcome measures: global score of Psychological General Well-Being Index (PGWBI) and the Beck Depression Inventory (BDI); secondary outcome measures: six separate dimensions of the PGWBI. RESULT(S): The OC treatment statistically significantly decreased general well-being compared with placebo -4.12 (95% CI, -7.18 to -1.06). Furthermore, OC decreased the following PGWBI dimensions compared with placebo: positive well-being -3.90 (95% CI, -7.78 to -0.01), self-control -6.63 (95% CI, -11.20 to -2.06), and vitality -6.84 (95% CI, -10.80 to -2.88). The effect of OC on depressive symptoms and on the PGWBI dimension depressed mood were not statistically significant. CONCLUSION(S): This study demonstrates a statistically significant reduction in general well-being by a first-choice OC in comparison with placebo in healthy women. We found no statistically significant effects on depressive symptoms. A reduction in general well-being should be of clinical importance.

Combined Oral Contraceptives and Sexual Function in Women-a Double-Blind, Randomized, Placebo-Controlled Trial.

CONTEXT: There is a lack of knowledge about how oral contraceptives may affect sexual function. OBJECTIVE: To determine whether there is a causal effect of oral contraceptives on sexuality. We hypothesized that a widely used pill impairs sexuality. DESIGN: A double-blind, randomized, placebo-controlled trial. Enrollment began in February 2012 and was completed in August 2015. SETTING: Karolinska University Hospital, Stockholm, Sweden. PARTICIPANTS: A total of 340 healthy women, aged 18-35 years, were randomized to treatment, and 332 completed the study. INTERVENTIONS: A combined oral contraceptive (150 µg levonorgestrel and 30 µg ethinylestradiol) or placebo for 3 months of treatment. MAIN OUTCOME MEASURES: The primary outcome was the aggregate score on the Profile of Female Sexual Function (PFSF). Secondary outcomes were the seven domains of the PFSF, the Sexual Activity Log, and the Personal Distress Scale. RESULTS: Overall sexual function was similar in women in the oral contraceptive and placebo groups. The PFSF domains desire (-4.4; 95% confidence interval [CI], -8.49 to -0.38; P = .032), arousal (-5.1; 95% CI, -9.63 to -0.48; P = .030), and pleasure (-5.1; 95% CI, -9.97 to -0.32; P = .036) were significantly reduced in comparison to placebo, whereas orgasm, concern, responsiveness, and self-image were similar between groups. The mean frequency of satisfying sexual episodes and personal distress were also similar between groups. CONCLUSIONS: This study shows no negative impact of a levonorgestrel-containing oral contraceptive on overall sexual function, although three of seven sexual function domains were adversely affected.

Cost-effectiveness of case-based training for primary care physicians in evidence-based medicine of patients with coronary heart disease.

BACKGROUND: We have shown that a case-based training programme for general practitioners, aimed to implement evidence-based care of patients at very high risk of coronary death, was associated with decreased mortality. In the present study we assessed long-term cost-effectiveness of this programme. DESIGN: Registry-based long-term cost-effectiveness analysis on a clinical trial. METHODS: Costs of the programme, health care, drugs and added years of life were included. Costs were adjusted to 2012 level and discounted by 3%. Life-years gained were estimated as the difference between the survival curves of the trial. The effectiveness measure, quality adjusted life-years (QALYs), was constructed by multiplying each life-year with a quality of life weight corresponding to the health status of that year. QALYs were also discounted by 3%. Incremental cost-effectiveness ratio (ICER) was estimated as the incremental cost per QALY gained. RESULTS: The number of undiscounted life-years gained was 365 days in the intervention group as compared to control (p = 0.02). The number of discounted QALYs gained was 0.66. The net increase in total costs was estimated as 17,862 € when costs of added years of life were included and 4621 € exclusive of these costs. This implied an ICER of 27,063 € per gained QALY. This ICER is well below commonly used threshold values of the societal willingness to pay for a QALY. CONCLUSIONS: The results show that a case-based training programme of general practitioners is a cost-effective way to save years of life in patients with very high risk of coronary death.

Cost of Preventing, Managing, and Treating Human Papillomavirus (HPV)-Related Diseases in Sweden before the Introduction of Quadrivalent HPV Vaccination.

OBJECTIVE: Costs associated with HPV-related diseases such as cervical dysplasia, cervical cancer, and genital warts have not been evaluated in Sweden. These costs must be estimated in order to determine the potential savings if these diseases were eradicated and to assess the combined cost-effectiveness of HPV vaccination and cervical cancer screening. The present study aimed to estimate prevention, management, and treatment costs associated with cervical dysplasia, cervical cancer, and genital warts from a societal perspective in Sweden in 2009, 1 year before the quadrivalent HPV vaccination program was implemented. METHODS AND MATERIALS: Data from the Swedish cervical cancer screening program was used to calculate the costs associated with prevention (cytological cervical cancer screening), management (colposcopy and biopsy following inadequate/abnormal cytological results), and treatment of CIN. Swedish official statistics were used to estimate treatment costs associated with cervical cancer. Published epidemiological data were used to estimate the number of incident, recurrent, and persistent cases of genital warts; a clinical expert panel assessed management and treatment procedures. Estimated visits, procedures, and use of medications were used to calculate the annual cost associated with genital warts. RESULTS: From a societal perspective, total estimated costs associated with cervical cancer and genital warts in 2009 were €106.6 million, of which €81.4 million (76%) were direct medical costs. Costs associated with prevention, management, and treatment of CIN were €74 million; screening and management costs for women with normal and inadequate cytology alone accounted for 76% of this sum. The treatment costs associated with incident and prevalent cervical cancer and palliative care were €23 million. Estimated costs for incident, recurrent and persistent cases of genital warts were €9.8 million. CONCLUSION: Prevention, management, and treatment costs associated with cervical dysplasia, cervical cancer, and genital warts are substantial. Defining these costs is important for future cost-effectiveness analyses of the quadrivalent HPV vaccination program in Sweden.