| 1. |
- Hao, Shuang, et al.
(författare)
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Influence of elicitation procedure and phrasing on health state valuations in experience-based time trade-off tasks among diabetes patients in China
- 2020
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Ingår i: Quality of Life Research. - : SPRINGER. - 0962-9343 .- 1573-2649. ; 29:1, s. 289-301
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Tidskriftsartikel (refereegranskat)abstract
- Purpose Open-ended and iteration-based time trade-off (TTO) tasks can both be used for valuation of health states. It has so far not been examined how the elicitation procedure affects the valuation of experience-based health states. The purpose of this study is to investigate the influence of elicitation procedure on experience-based health state values elicited by the TTO method. Methods 156 Chinese adults with type 2 diabetes participated in face-to-face interviews with an open-ended or an iteration-based TTO task. The association between the type of TTO task and the valuation of health states was investigated through multiple linear regression analyses. A modified open-ended TTO task was also developed (n = 33) to test whether different phrasings of open-ended TTO tasks influence TTO values. Results Higher TTO values were observed in the original open-ended TTO task compared to the iteration-based task, which indicates that the elicitation procedure influences the valuation of health states. When the modified open-ended task was introduced, the difference between the two elicitation procedures was no longer statistically significant, suggesting that the phrasing and/or visual presentation of the TTO task may influence the valuation of health states. Conclusions The choice of elicitation procedure as well as the description of experience-based TTO tasks may influence the valuation of health states. Further research is warranted, also in other cultural contexts, to further explore these findings.
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| 2. |
- Hofmann, Robin, et al.
(författare)
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Avoiding Routine Oxygen Therapy in Patients With Myocardial Infarction Saves Significant Expenditure for the Health Care System—Insights From the Randomized DETO2X-AMI Trial
- 2022
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Ingår i: Frontiers In Public Health. - Lausanne, Switzerland : Frontiers Media SA. - 2296-2565. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- Background: Myocardial infarction (MI) occurs frequently and requires considerable health care resources. It is important to ensure that the treatments which are provided are both clinically effective and economically justifiable. Based on recent new evidence, routine oxygen therapy is no longer recommended in MI patients without hypoxemia. By using data from a nationwide randomized clinical trial, we estimated oxygen therapy related cost savings in this important clinical setting. Methods: The DETermination of the role of Oxygen in suspected Acute Myocardial Infarction (DETO2X-AMI) trial randomized 6,629 patients from 35 hospitals across Sweden to oxygen at 6 L/min for 6–12 h or ambient air. Costs for drug and medical supplies, and labor were calculated per patient, for the whole study population, and for the total annual care episodes for MI in Sweden (N = 16,100) with 10 million inhabitants. Results: Per patient, costs were estimated to 36 USD, summing up to a total cost of 119,832 USD for the whole study population allocated to oxygen treatment. Applied to the annual care episodes for MI in Sweden, costs sum up to between 514,060 and 604,777 USD. In the trial, 62 (2%) patients assigned to oxygen and 254 (8%) patients assigned to ambient air developed hypoxemia. A threshold analysis suggested that up to a cut-off of 624 USD spent for hypoxemia treatment related costs per patient, avoiding routine oxygen therapy remains cost saving. Conclusions: Avoiding routine oxygen therapy in patients with suspected or confirmed MI without hypoxemia at baseline saves significant expenditure for the health care system both with regards to medical and human resources. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT01787110. Copyright © 2022 Hofmann, Abebe, Herlitz, James, Erlinge, Alfredsson, Jernberg, Kellerth, Ravn-Fischer, Lindahl, Langenskiöld and DETO2X-SWEDEHEART Investigators.
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| 3. |
- Hofmann, R., et al.
(författare)
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Routine Oxygen Therapy Does Not Improve Health-Related Quality of Life in Patients With Acute Myocardial Infarction—Insights From the Randomized DETO2X-AMI Trial
- 2021
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Ingår i: Frontiers in Cardiovascular Medicine. - : Frontiers Media S.A.. - 2297-055X. ; 8
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Tidskriftsartikel (refereegranskat)abstract
- Background: After decades of ubiquitous oxygen therapy in all patients with acute myocardial infarction (MI), recent guidelines are more restrictive based on lack of efficacy in contemporary trials evaluating hard clinical outcomes in patients without hypoxemia at baseline. However, no evidence regarding treatment effects on health-related quality of life (HRQoL) exists. In this study, we investigated the impact of routine oxygen supplementation on HRQoL 6–8 weeks after hospitalization with acute MI. Secondary objectives included analyses of MI subtypes, further adjustment for infarct size, and oxygen saturation at baseline and 1-year follow-up.Methods: In the DETermination of the role of Oxygen in suspected Acute Myocardial Infarction (DETO2X-AMI) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 L/min for 6–12 h or ambient air. In this prespecified analysis, patients younger than 75 years of age with confirmed MI who had available HRQoL data by European Quality of Life Five Dimensions questionnaire (EQ-5D) in the national registry were included. Primary endpoint was the EQ-5D index assessed by multivariate linear regression at 6–10 weeks after MI occurrence.Results: A total of 3,086 patients (median age 64, 22% female) were eligible, 1,518 allocated to oxygen and 1,568 to ambient air. We found no statistically significant effect of oxygen therapy on EQ-5D index (−0.01; 95% CI: −0.03–0.01; p = 0.23) or EQ-VAS score (−0.57; 95% CI: −1.88–0.75; p = 0.40) compared to ambient air after 6–10 weeks. Furthermore, no significant difference was observed between the treatment groups in EQ-5D dimensions. Results remained consistent across MI subtypes and at 1-year follow-up, including further adjustment for infarct size or oxygen saturation at baseline.Conclusions: Routine oxygen therapy provided to normoxemic patients with acute MI did not improve HRQoL up to 1 year after MI occurrence. Clinical Trial Registration: ClinicalTrials.gov number, NCT01787110.
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| 4. |
- Johansson, Per, et al.
(författare)
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Causal inferences and real-world evidence : A comparative effectiveness evaluation of abiraterone acetate against enzalutamide
- 2023
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Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 18:10
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Tidskriftsartikel (refereegranskat)abstract
- Regulatory authorities are recognizing the need for real-world evidence (RWE) as a complement to randomized controlled trials in the approval of drugs. However, RWE needs to be fit for regulatory purposes. There is an ongoing discussion regarding whether pre-publication of a protocol on appropriate repositories, e.g. ClinicalTrials.gov, would increase the quality of RWE or not. This paper illustrates that an observational study based on a pre-published protocol can entail the same level of detail as a protocol for a randomized experiment. The strategy is exemplified by designing a comparative effectiveness evaluation of abiraterone acetate against enzalutamide in clinical practice. These two cancer drugs are prescribed to patients with advanced prostate cancer. Two complementary designs, including pre-analysis plans, were published before data on outcomes and proxy-outcomes were obtained. The underlying assumptions are assessed and both analyses show an increased mortality risk from being prescribed abiraterone acetate compared to enzalutamide.
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| 5. |
- Johansson, Per, et al.
(författare)
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Study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide : a longitudinal study based on Swedish administrative registers
- 2021
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 11:10
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Tidskriftsartikel (refereegranskat)abstract
- Introduction This paper presents a study protocol for a comparative effectiveness evaluation of abiraterone acetate against enzalutamide in clinical practice, two cancer drugs given to patients suffering from advanced prostate cancer.Method and analysis The protocol designs a comparative-effectiveness analysis of abiraterone acetate against enzalutamide. With the substantial number of covariates a two-step procedure is suggested in choosing relevant covariates in the matching design. In the first step, an exploratory factor analysis reduces the dimension of a large set of continuous covariates to nine factors. In the second step, we reduce the dimension of the covariates, interactions and second order terms for the continuous covariates using propensity score estimation. The final design makes use of a genetic matching algorithm. The study protocol provides a detailed statistical analysis plan of the analysis sample derived from the matching design. The analysis will make use of linear regression and robust inference adjusted for multisignificance testing.Discussion As in a randomised experiment the focus is on the design of the assignment to treatment. This allows the publication of this preanalysis plan before having access to outcome data. This means that the p values will be correct if the maintained assumption of uncounfoundedness is valid. Given that is p-hacking is substantial problem in empirical research, this is a substantial strength of this study. However, while design yields, balance on the observed covariates one cannot discard the possibility that unobserved confounders are not balanced. For that reason, sensitivity tests for the maintained assumption of uncounfoundedness are presented.Ethics and dissemination The study was approved by the Regional Ethical Review Board in Uppsala, Sweden (Dnr 2017/482). Results will be published in a peer-reviewed journal and distributed to relevant stakeholders in healthcare.
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| 6. |
- Jonéus, Paulina, et al.
(författare)
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Novel hormonal therapy versus standard of care : a registry-based comparative effectiveness evaluation for mCRPC-patients
- 2024
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Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 19:2
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundThis paper presents results from one of the few comparative effectiveness evaluations of novel antiandrogen medications (NHT) against standard of care (SoC) for patients suffering from metastatic castrate-resistant prostate cancer (mCRPC).MethodsThe design and the analysis are published in a protocol before accessing outcome data. Two groups of patients are balanced on hundreds of important covariates measured before the prostate cancer diagnosis and up to the date of the prescription. While the design yields balance on the observed covariates, one cannot discard the possibility that unobserved confounders are not balanced. The unconfoundedness assumption is assessed by estimating placebo regressions on two health measures, not included in the design but added together with the outcome data after protocol publication.ResultsWe find a substantial (64 percent) increase in mortality for patients prescribed with NHT rather than SoC. However, based on the results from one of the two placebo regressions, we cannot rule out that the difference in mortality may be due to confounding. Using a bounding strategy of the effect, we can, however, rule out that NHT reduces mortality compared to SoC. Under an empirical valid assumption that most mCRPC patients who die suffer from bone metastases, we have a strong indication of increased skeleton-related events in patients if prescribed NHT against SoC.ConclusionsGenerally, the SoC for this group of patients is docetaxel. Given the substantially higher costs of many of the NHT, the finding of no positive effects from NHT on both mortality and SRE is important. More comparative studies, including studies analysing quality of life outcomes, are thus needed.
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| 7. |
- Sakari, Thorbjörn, et al.
(författare)
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Economic Consequences of Surgery for Adhesive Small Bowel Obstruction : A Population-Based Study
- 2023
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Ingår i: Gastroenterology Research and Practice. - : Hindawi Publishing Corporation. - 1687-6121 .- 1687-630X. ; 2023
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Tidskriftsartikel (refereegranskat)abstract
- Background and Aims. Most patients develop adhesions after abdominal surgery, some will be hospitalized with small bowel obstruction (SBO), and some also require surgery. The operations and follow-up are expensive, but recent data of costs are scarce. The aim of this study was to describe the direct costs of SBO-surgery and follow-up, in a population-based setting. The association between cost of SBO and peri- and postoperative data was also studied.Methods. In a retrospective cohort study, all patients (n = 402) operated for adhesive SBO in Gävleborg and Uppsala counties (2007–2012) were studied. The median follow-up was 8 years. Costs were calculated according to the pricelist of Uppsala University Hospital, Uppsala, Sweden.Results. Overall total costs were €16.267 million, corresponding to a mean total cost per patient of €40,467 during the studied period. Diffuse adhesions and postoperative complications were associated with increased costs for SBO in a multivariable analysis (P < 0.001). Most costs, about €14 million (85%), arouse in conjunction with the SBO-index surgery period. In-hospital stay was the dominating cost, accounting for 70% of the total costs.Conclusion. Surgery for SBO generates substantial economic burden for healthcare systems. Measures that reduce the incidence of SBO, the frequency of postoperative complication, or the length of stay have the potential to reduce this economic burden. The cost estimates from this study may be valuable for future cost–benefit analyses in intervention studies.
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| 8. |
- Ssegonja, Richard, et al.
(författare)
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Cost-effectiveness of an indicated preventive intervention for depression in adolescents: a model to support decision making
- 2020
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Ingår i: Journal of Affective Disorders. - : Elsevier. - 0165-0327 .- 1573-2517. ; 277, s. 789-799
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Tidskriftsartikel (refereegranskat)abstract
- Background: Adolescent depression has negative health and economic outcomes in the shortand long-term. Indicated preventive interventions, in particular group based cognitive behavioural therapy (GB-CBT), are ef-fective in preventing depression in adolescents with subsyndromal depression. However, little is known about the cost-effectiveness of these interventions. Methods: A Markov cohort model was used to conduct cost-effectiveness analyses comparing a GB-CBT indicated preventive intervention for depression, to a no-intervention option in a Swedish setting. Taking a time horizon of 5and 10 years, incremental differences in societal costs and health benefits expressed as differences in the proportion of cases of depression prevented, and as quality adjusted life years (QALYs) gained were estimated. Through univariate and probabilistic sensitivity analyses, the robustness of the results was explored. Costs, presented in 2018 USD, and effects were discounted at a yearly rate of 3%. Results: The base-case analysis showed that GB-CBT indicated preventive intervention incurred lower costs, prevented a larger proportion of cases of depression and generated higher QALYs compared to the no -intervention option for both time horizons. Offering the intervention was even a cost saving strategy and demonstrated a probability of being cost-effective of over 95%. In the sensitivity analyses, these results were robust to the modelling assumptions. Limitations: The study considered a homogeneous cohort and assumed a constant annual decay rate of the relative treatment effect. Conclusions: GB-CBT indicated preventive interventions for depression in adolescence can generate good value for money compared to leaving adolescents with subsyndromal depression untreated.
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| 9. |
- Ssegonja, Richard
(författare)
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Effectiveness and cost-effectiveness of indicated preventive interventions for depression in adolescents : An application of health economics methods
- 2020
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Unipolar depressive disorders are commonly encountered conditions in clinical practice with about 25% reporting their first episode during adolescence. Longitudinal studies show adolescent depression to be associated with an increased risk of mental illness in adulthood, healthcare usage, poor educational outcomes, unemployment, and dependency on welfare recipiency. Therefore, adolescent depression contributes a high disease burden and impinges a considerable financial strain on society’s limited resources.Several preventive interventions have been developed to prevent adolescent depression. Of these interventions, group-based cognitive behavioural therapy (GB-CBT) indicated preventive interventions for depression are well studied and accepted. However, evaluations of their effectiveness and cost effectiveness have yielded conflicting and incomplete results mainly due to methodological limitations.Therefore, the overarching aim of this thesis was to investigate the effectiveness and cost-effectiveness of GB-CBT indicated preventive interventions for depression in children and adolescents, and estimate the additional healthcare costs and welfare burden in early to mid-adulthood associated with adolescent depression.In study I, GB-CBT indicated preventive interventions for depression in children and adolescents were protective against developing a depressive disorder and also reduced depressive symptoms. The intervention relative effect was noted to decay over time. Study II revealed that adolescent depression was associated with considerable increased healthcare consumption in mid-adulthood compared to the non-depressed peers at a population level. This finding was more pronounced in females with persistent depressive disorder (PDD). Study III showed adolescent depression to be associated with all the forms of social transfer payments (welfare) especially in individuals with PDD and those with early comorbid psychopathologies.Study IV demonstrated that GB-CBT indicated preventive interventions for adolescent depression are not only effective but also have the potential to be cost-effective compared to leaving adolescents with subsyndromal depression unattended.Findings from studies II and III, emphasized the large financial burden to society in terms of additional healthcare costs and welfare expenditure associated with adolescent depression. Whereas, study I and IV bring forward the message that it is possible to change the course of subsyndromal depression by offering GB-CBT indicated preventive interventions to adolescents with subsyndromal depression. Such an initiative was not only cost-effective compared to not intervening, but also largely cost-saving. Therefore, GB-CBT indicated preventive interventions could be used as part of a stepped care program linking into more specialized care services. The results of this thesis will be useful in decision-making concerning the resource allocation related to adoption and implementation of such preventive measures.
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