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- Eckard, Nathalie, 1973-
(författare)
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The matter of economic evaluations in health policy decision-making : The case of the Swedish national guidelines for heart diseases
- 2015
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Economic evaluations are used to inform decision makers about the efficient allocation of scarce healthcare resources and are generated with the direct intent to support decisions in healthcare. Producing guidelines is a complex process and the inclusion of health-economic aspects in the formulation of the Swedish national guidelines as a basis for the written recommendations (priority gradings), distinguishes them from their European counterparts. Despite the increased use of cost-effectiveness data in decision-making, little is known about the actual use of such data. This thesis covers issues concerning how economic evaluations matter in health policy decision-making. The thesis includes four papers based on the Swedish national guidelines for heart diseases, one of the most prominent examples in Sweden of following the notion of evidence-based policy (EBP), in order to inform explicit priority setting.Both Papers I and II followed a qualitative case study design, based on the same data set. Paper I explored how a specific working group, the Priority Setting Group (PSG), handled the various forms of evidence and values when producing the national guidelines. Two themes were identified in reaching collective agreement in priority gradings; group facilitation activities and avoiding deadlock in the discussion. The work process involved disagreement and negotiation as part of that task. Paper I contributes to the theoretical and practical debate on EBP. Paper II focused on the use of cost-effectiveness data as decision support in the PSG work process. The paper addressed availability of cost-effectiveness data, evidence understanding, interpretation difficulties, and the reliance on evidence. Three themes were identified. The paper contributes to knowledge on how cost-effectiveness evidence was used in actual decision-making. The use of cost-effectiveness evidence was one of many tools employed to avoid deadlock in discussion and to reach a priority grading, when the overall evidence base was weak, in times of uncertainty and on the introduction of new expensive medical technologies.Quantitative research methods were used for both Papers III and IV. Paper III explored how the PSG was presented with cost-effectiveness evidence as decision support and as a basis for their priority gradings. Cost-effectiveness ratios (ICERs) were provided, based on a systematic literature review, as well as how the results may be conveyed and communicated, for the treatment of heart diseases using a cost-effectiveness ranking or league and providing valid information within a limited space, aiding decision makers on the allocation of healthcare resources. The thesis also includes decision support in the form of cost-effectiveness analysis on catheter ablation treatment. Paper IV provides an example of presenting evidence in the form of a decision-analytic model. The modelling approach provides an analytic framework for decision-making, specifically under conditions of uncertainty as in the introduction of new medical technology. Catheter ablation was associated with reduced cost and an incremental gain in quality adjusted life years (QALYs), and was considered a cost-effective treatment strategy compared to the medical treatment strategy in a lifetime perspective.
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- Janzon, Magnus, 1961-
(författare)
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Treatment strategies in unstable coronary artery disease : economic and quality of life evaluations
- 2003
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- During the past few decades two treatment strategies have evolved for patients with unstable coronary artery disease (UCAD). The non-invasive strategy uses clinical investigations and non-invasive stress tests to identify patients who need diagnostic catheterisation. The early invasive strategy uses coronary catheterisation as the diagnostic instrument. The new technologies have consequences not only for the clinical endpoints of death or myocardial infarction (MI), but also in terms of health-related quality of life and costs. The economic evaluations are of great importance due to the high incidence of the disease and high short-term costs of the invasive strategy. The early costly intervention may prevent later complications and thereby partly or completely offset the higher initial treatment costs. Even if longterm costs remain higher, they can be justified by improved survival or quality of life. Such clinical effects in the long-term follow-up need to be seen in relation to the cost of the strategy. In a prospective Scandinavian multi centre trial we examined 3489 patients with UCAD. The purpose of this thesis was to study the treatment strategies in UCAD with respect to cost-effectiveness and patients' health-related quality of life. This purpose was divided into four aims:The first aim was to evaluate the cost-effectiveness of extended treatment with the low-molecular-weight heparin dalteparin. 2267 patients were randomised. The incremental cost-effectiveness ratio for administering dalteparin treatment for one month was SEK 30,300 per avoided death or MI. Since the resources for early intervention are limited in many countries, extended dalteparin treatment for up to one month is a cost-effective bridge to invasive intervention.The second aim was to evaluate the short-term costs and cost-effectiveness of the invasive strategy compared to the non-invasive strategy. A total of 2457 patients were randomised. The results were analysed in a societal perspective. The difference in mean total costs after one year was SEK 23,900 (p < 0.001), favouring the non-invasive strategy. The incremental cost-effectiveness ratio for choosing the invasive instead of the non-invasive strategy was SEK 645,000 per avoided death or MI. The high cost at the beginning of the invasive strategy was substantial. For policy discussions concerning implementing the invasive strategy, these positive results should be balanced against the cost-consequences of the strategy.The third aim was to evaluate the patients' health-related quality of life with respect to the strategies. We used two questionnaires, the generic Short Form 36 (SF-36) and the disease-specific Angina Pectoris Quality of Life Questionnaire (APQLQ), at randomisation and after three, six and 12 months of followup. The invasively treated group showed a significantly better health-related quality of life at the threeand six-month follow-ups (p < 0.01) than the non-invasively treated group. These differences remained at the 12-month follow-up. The disease-specific quality of life results were similar.The fourth aim was to evaluate the long-term cost-effectiveness and cost-utility of these strategies. Results were analysed in both a societal and a health care provider perspective. The difference in mean total cost SEK 11,400 was not statistically significant. The estimated cost per quality adjusted life year (QALY) gained for the invasive strategy, based on within trial results and projected life expectancy, was SEK 22,900. These results were consistent in most subgroups. The estimated cost per life year gained was SEK 57,700. Compared to other accepted treatments in the cardiovascular field, the cost per QALY gained is very low.In summary, this thesis shows that the early invasive treatment strategy for patients with UCAD promotes health-related quality of life and is highly cost-effective when compared to many other interventions in the cardiovascular field and should therefore be recommended.
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- Johannesen, Kasper, 1982-
(författare)
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The value of evaluating and implementing pharmaceuticals
- 2021
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Pharmaceuticals are a central part of high-quality health care and a resource for improving population health. However, high prices set by private companies who develop and own the rights to new pharmaceuticals question the value that they contribute to the health care system. Publicly funded health care systems need to get the most from limited health care resources, which has become even more apparent in recent years with ageing populations, rapid technological development, and more recently the impact of COVID-19. Reducing pharmaceutical prices increase the current value that they offer to health care systems, but price reduction also decreases incentives to develop future treatments. Hence, the health care systems must balance the objective of improving the value from the treatments available today and incentivising the development of future treatments. Governments and health care decision makers use a variety of policies to control prices and use of pharmaceuticals. However, these policies are rarely the focus of formal analysis and their effect on short- and long-term population health is often unclear. The aim of this thesis was to investigate how policies that control pharmaceutical prices and implementation impact population health and incentives for pharmaceutical research and development (R&D). The first study in this thesis outlines a framework for assessing the effect of pharmaceutical policies on population health and pharmaceutical earnings and shows that price reducing policies can increase the current value of pharmaceuticals to health care systems while lowering R&D incentives. The design of specific policies determines the impact as well as the distribution of the gains of lower prices across patients, health care providers, pharmacies, and other affected parties. The second study analyses the trade-off between accuracy and cost of the cost-effectiveness appraisals for pharmaceuticals by viewing it as a diagnostic test that aims to identify costeffective treatments. The study identifies some policy relevant conclusions, including that the process should be flexible over time and depend on characteristics of the treatment undergoing assessment. Study three, investigating the impact of regional implementation variation of the antiplatelet ticagrelor, found that an additional 1,100 Quality Adjusted Life Years (QALYs) could have been gained from achieving equal implementation across health care regions. This represents a value of SEK 285 million from avoiding regional implementation variation of ticagrelor (given a value of SEK 250,000 per QALY). The study also shows that avoiding delays due to sequential decisions on reimbursement, treatment guidelines, and funding could have significant value. Finally, the fourth study investigates the comparative effectiveness of ticagrelor using observational data collected as part of routine clinical care in the SWEDEHEART registry. The study finds similar reduction in mortality as observed in the pivotal randomised clinical trial of ticagrelor, the PLATO trial. Furthermore, the importance of appropriate methods for observational research on comparative effectiveness are demonstrated, highlighting the importance of using appropriate methods when investigating the effectiveness of treatments used in clinical practice. In conclusion, this thesis shows the importance of analysing and understanding the effect of policies that control price and implementation of pharmaceuticals, whether the goal is to maximise the value from currently available pharmaceuticals or to also incentivise the development of new pharmaceuticals. Although the value of improving implementation may not be as obvious or tangible as savings from lowering pharmaceutical prices, improving implementation may contribute more to population health than reinvesting potential savings from price reductions.
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- Sandstedt, Mårten, 1972-
(författare)
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Computed Tomography of the Coronary Arteries : Developmental and Prognostic Investigations
- 2020
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Computed tomography (CT) is an increasingly used modality for investigations of patients with suspected coronary artery disease (CAD). Technical advances could improve diagnostic accuracy and lead to clinical workflow improvements. Also, more prognostic information can optimize clinical follow-up strategies and treatments.The general aim of this thesis was to explore the use of CT for CAD investigations. Three studies aimed to examine new technologies, including the evaluation of an on-site, computed tomography-based fractional flow reserve (CT-FFR) software (study I), the evaluation of an AI-based, calcium scoring computed tomography (CSCT) software (study III), and the evaluation of an photon-counting detector (PCD)-CT (study IV). One study aimed to evaluate the long-term prognostic value of coronary computed tomography angiography (CCTA) in symptomatic patients with no history of CAD (study II).The software evaluation studies (study I and III) and the prognostic study (study II) utilized CT data from clinical patients, while the PCD-CT evaluation study (study IV) used CT data from cadaveric specimens. The performances of both software programs were compared with standard references, being represented by fractional flow reserve (FFR) measurements (study I), and coronary artery calcification (CAC) scores from a semi-automatic software (study III), respectively. The PCD-CT performance on CAC quantification was compared with corresponding results from an energy integrating detector (EID)-CT, using micro-CT as the standard reference (study IV). The prognostic study merged registries to identify major adverse cardiac events (MACE), having a follow-up time of up to 7.5 years (study II).The CT-FFR and CSCT software correlation and agreement to corresponding standard references were good and excellent, respectively. Also, both software programs had time-saving potential (study I and III). The CAC quantification was more accurate using PCD-CT than EID-CT (study IV). The prognosis was excellent in patients with normal coronary arteries, and progressively impaired in non-obstructive and obstructive CAD (study II).The results in this thesis convey developmental, technical CT technology advances for CAD investigations. In addition, prognostic follow-up data is communicated. The results may benefit patients by an increased accuracy in the CT evaluation of CAD and can contribute to improve clinical follow-up strategies. Furthermore, the results suggest possibilities to improve the workflow in clinical radiology, which potentially could impact health care costs.
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- Tödt, Tim, 1964-
(författare)
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Strategies to improve outcome in patients with ST elevation myocardial infarction treated with primary PCI
- 2012
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background: ST elevation myocardial infarction (STEMI) caused by a ruptured atherosclerotic plaque with overlying thrombosis leads to ischemia and progressively to the death of the myocardial cells supplied by the affected coronary artery. Rapid reperfusion with primary Percutaneous Coronary Intervention (PCI) in an experienced centre is the preferred therapy for these patients. The aim of the research program on which this thesis is based was to study the effect of antiplatelet therapy with abciximab on coronary patency when administered early to an unselected cohort of patients with STEMI intended for primary PCI, to study the impact of health care delay time on infarct size measured with contrast enhanced Magnetic Resonance Imaging (ceMRI), and to evaluate if time delays could be reduced through reorganisation of logistics and personal feedback to staff involved in the care of STEMI patients. Finally measures of wall motion on cine MRI were evaluated to elucidate if functional measurements of the left ventricular wall could detect scar tissue visualised on ceMRI in a post-acute phase of primary PCI.Material and results: In paper I we report on a study of all consecutive patients who sustained a STEMI in 2005 in the county of Östergötland and who were to be treated with primary PCI. Abciximab given as pretreatment before (n=133) or at the cath-lab after a diagnostic angiography (n=109) was associated with a patent Infarct Related Artery (IRA), i.e. Thrombolysis in Myocardial Infarction (TIMI) flow 2-3, in 45.9% of patients in the early group versus 20.2% in the cath-lab group, p=0.0001. There were no statistically significant differences in bleeding or mortality rate during the initial hospital stay, nor were there any significant differences between the groups during one-year follow up regarding a Major Adverse Cardiac Event (MACE).Paper II is based on an examination of 30 patients in a stable clinical condition with ceMRI 4-8 weeks after they had been treated with primary PCI because of STEMI. Patients were selected on the presence of extensive myocardial scar in the anteroseptal segments (n=17) or no scar visible at all in this area or in any other part of the myocardium (n=13). The purpose of the study was to evaluate the ability of a new feature tracking software to measure functional parameters of the heart. The left ventricular wall was divided into 18 segments and myocardial contraction was measured with velocity, displacement and strain in the longitudinal and radial direction. The software calculated a mean value for the 18 segments for each parameter. Receiver-operatorcharacteristics curves (ROC) were constructed. The best area-under-curve (AUC) was for radial strain where a cut-off value of 38.8% had 80% sensitivity and 86% specificity to detect segments with scar>50%.The impact of health care delay was examined in paper III based on a study in which 89 STEMI patients treated with primary PCI had their infarct size measured with ceMRI in the post-acute phase. Time from First Medical Contact (FMC) to a patent artery correlated weakly with infarct size, r=0.27, p=0.01. However, multivariable analysis showed the LAD as the Infarct Related Artery (IRA), active smoking and occlusion of the IRA at the time of the diagnostic angiogram were correlated with infarct size and that time from FMC to patent artery was not so correlated.Finally, in the study leading to paper IV, extensive measurements on time delays were performed on 67 consecutive patients with STEMI treated with primary PCI. Through collaboration with different stakeholders in the treatment of STEMI in the catchment area the following types of targeted refining of logistics were done; 1. Ambulance staff prioritise ECG recording, 2. Central evaluation of ECG in all patients with suspected STEMI, and 3. PCI team is ready to accept the patient when two out of three members are on site. Moreover, personal feedback on time delays for each STEMI patient was given to all staff involved in the treatment of the patient. Thereafter, all the time delays for a similar group of consecutive STEMI patients (n=89) were analysed and compared with the delays for the former group. Improvements seen in the post-intervention group were a reduction in time from ECG to cath-lab arrival by 11 minutes, p=0.02 and a non-significant decrease of FMC to a patent artery by six minutes. The main part of this improvement could probably be ascribed to the decision to see to it that an attending cardiologist was present 24/7 and to central evaluation of ECG.Conclusion: Abciximab given as pre-treatment to patients with STEMI intended for primary PCI was associated with a patent artery in 46% of patients. Moreover, we demonstrated a relationship between health care delay time and infarct size. This delay time could be reduced by a reorganisation of logistics and personal feedback on time delays. Finally, feature tracking analysis of cine MR images could detect segments with extensive myocardial scar in anterior infarction with 80% sensitivity and 86% specificity.
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