| 1. |
- Björnerstedt, Jonas, et al.
(author)
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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
- 2024
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In: Journal of Medical Economics. - : Taylor & Francis. - 1369-6998 .- 1941-837X. ; 27:1, s. 193-200
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Journal article (peer-reviewed)abstract
- 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 17%, and underestimate observed LYs by 5% and 1% 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 and control group, respectively, 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.
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| 2. |
- Ernstsson, Olivia, et al.
(author)
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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
- 2024
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In: Nordic Journal of Psychiatry. - : Taylor & Francis. - 0803-9488 .- 1502-4725. ; 78:2, s. 137-145
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Journal article (peer-reviewed)abstract
- 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.
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| 3. |
- Löhr, J.-Matthias, et al.
(author)
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Can our experience with surveillance for inherited pancreatic cancer help to identify early pancreatic cancer in the general population?
- 2024
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In: Familial Cancer. - : Springer Nature. - 1389-9600 .- 1573-7292.
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Research review (peer-reviewed)abstract
- 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.
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| 4. |
- Kirketeig, Terje, et al.
(author)
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Real-world outcomes in spinal cord stimulation : predictors of reported effect and explantation using a comprehensive registry-based approach
- 2023
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In: Pain Reports. - : Lippincott Williams & Wilkins. - 2471-2531. ; 8:6
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Journal article (peer-reviewed)abstract
- 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.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.
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| 5. |
- Söreskog, Emma, et al.
(author)
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Impact of spinal cord stimulation on sick leave and disability pension in patients with chronic neuropathic pain : a real-world evidence study in Sweden
- 2023
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In: Pain. - : Lippincott Williams & Wilkins. - 0304-3959 .- 1872-6623. ; 164:3, s. 666-673
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Journal article (peer-reviewed)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 euro4127 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.
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| 6. |
- Parslow, Elle, et al.
(author)
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The digit ratio (2D:4D) and economic preferences: no robust associations in a sample of 330 women
- 2019
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In: Journal of the Economic Science Association. - : Springer Science and Business Media LLC. - 2199-6784 .- 2199-6776. ; 5:2
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Journal article (peer-reviewed)abstract
- 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 an effect for sixteen of the eighteen total regressions we run. The two regression specifications which are 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.
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| 7. |
- Döring, Nora, et al.
(author)
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Economic evaluation of primrose-a trial-based analysis of an early childhood intervention to prevent obesity
- 2018
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In: Frontiers in Endocrinology. - : Frontiers Media SA. - 1664-2392. ; 9:MAR
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Journal article (peer-reviewed)abstract
- 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.
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| 8. |
- Ranehill, Eva, et al.
(author)
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Hormonal Contraceptives Do Not Impact Economic Preferences: Evidence from a Randomized Trial
- 2018
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In: Management science. - : Institute for Operations Research and the Management Sciences (INFORMS). - 0025-1909 .- 1526-5501. ; 64:10, s. 4471-4965
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Journal article (peer-reviewed)abstract
- A growing body of correlational studies suggests that sex hormones such as those contained in, or affected by, oral contraceptives (OCs) may impact economic behavior. However, despite widespread use of OCs among women in Western countries, little is known about their potential behavioral effects. The present study investigates whether OCs causally influence economic preferences. We randomly allocate 340 women aged 18–35 to three months of a widely used OC or placebo treatment. At the end of treatment, we conduct an economic experiment measuring altruism, financial risk taking, and willingness to compete. The statistical power is 80% to detect an effect size equal to a Cohen’s d of 0.30 at the 5% level. We find no significant effects of OCs on any of the measured preferences, indicating that this widely used OC treatment, commonly used throughout the world, does not significantly affect the measured economic preferences. Further, we find no relation between menstrual cycle phase and economic preferences in the placebo group.
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| 9. |
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| 10. |
- Johannesson, Magnus, et al.
(author)
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Combined Oral Contraceptives and Sexual Function in Women-a Double-Blind, Randomized, Placebo-Controlled Trial
- 2016
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In: Journal of Clinical Endocrinology and Metabolism. - : Oxford University Press (OUP): Policy B - Oxford Open Option A. - 0021-972X .- 1945-7197. ; 101:11, s. 4046-4053
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Journal article (peer-reviewed)abstract
- 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 mu g levonorgestrel and 30 mu g 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.
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