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Zechmeister-Koss I.,Ludwig Boltzmann Institute for Health Technology Assessment | Schnell-Inderst P.,University of Medical Sciences and Technology | Zauner G.,DWH Simulation Services
Medical Decision Making

Background. An increasing number of evidence sources are relevant for populating decision analytic models. What is needed is detailed methodological advice on which type of data is to be used for what type of model parameter. Purpose. We aim to identify standards in health technology assessment manuals and economic (modeling) guidelines on appropriate evidence sources and on the role different types of data play within a model. Methods. Documents were identified via a call among members of the International Network of Agencies for Health Technology Assessment and by hand search. We included documents from Europe, the United States, Canada, Australia, and New Zealand as well as transnational guidelines written in English or German. We systematically summarized in a narrative manner information on appropriate evidence sources for model parameters, their advantages and limitations, data identification methods, and data quality issues. Results. A large variety of evidence sources for populating models are mentioned in the 28 documents included. They comprise research- and non-research-based sources. Valid and less appropriate sources are identified for informing different types of model parameters, such as clinical effect size, natural history of disease, resource use, unit costs, and health state utility values. Guidelines do not provide structured and detailed advice on this issue. Limitations. The article does not include information from guidelines in languages other than English or German, and the information is not tailored to specific modeling techniques. Conclusions. The usability of guidelines and manuals for modeling could be improved by addressing the issue of evidence sources in a more structured and comprehensive format. © The Author(s) 2013. Source

Zechmeister-Koss I.,Ludwig Boltzmann Institute for Health Technology Assessment | Huic M.,Agency for Quality and Accreditation in Health Care and Social Welfare | Fischer S.,Ludwig Boltzmann Institute for Health Technology Assessment
Obesity Surgery

This systematic literature review applies the GRADE approach to evaluate the efficacy and safety of the duodenal-jejunal bypass liner (DJBL) for the treatment of (a) patients with obesity ≥ grade II (with comorbidities) and (b) patients with type 2 diabetes mellitus + obesity ≥ grade I. We included ten studies with a total of 342 patients that primarily investigated a prototype of the DJBL. In high-grade obese patients, short-term excess weight loss was observed. For the remaining patient-relevant endpoints and patient populations, evidence was either not available or ambiguous. Complications (mostly minor) occurred in 64-100 % of DJBL patients compared to 0-27 % in the control groups. Gastrointestinal bleeding was observed in 4 % of patients. We do not yet recommend the device for routine use. © 2013 Springer Science+Business Media New York. Source

Schumacher I.,Ludwig Boltzmann Institute for Health Technology Assessment | Zechmeister I.,Ludwig Boltzmann Institute for Health Technology Assessment
International Journal of Technology Assessment in Health Care

Objectives: In Austria, research in health technology assessment (HTA) has been conducted since the 1990s. The aim of this study is to analyze whether the HTA research program of the Institute of Technology Assessment (ITA) and the Ludwig Boltzmann Institute for HTA (LBI-HTA) have had an impact on the Austrian healthcare system. Methods: We applied qualitative and quantitative empirical research methods, such as interviewing, download analysis, questionnaire, retrospective routine data analysis, and media analysis. Data were analyzed according to a conceptual framework, considering seven impact categories (awareness, acceptance, process, decision, practice, final outcomes, enlightenment) and different target groups. Results: A rising number of downloads and single HTA reports with high media interest were identified. Interviews showed that HTA reports have increasingly been used for investment and reimbursement decisions, as well as for the preparation of negotiations. Economic impact was indicated by decreased expenditures due to HTA recommendations. Overall, knowledge about evidence-based medicine increased and, in places, an HTA culture can be recognized. Yet, several decision-making processes occur at all levels without the use of HTA. Conclusions: The analysis demonstrated an impact within all predefined categories; however, it depends on the system level and its target groups. HTA reports are primarily used by hospital management, (social) insurances, and the Austrian Ministry of Health. Nevertheless, there is still potential to increase the impact of HTA. Therefore, the inclusion of HTA in decision-making processes in Austria needs to move from a voluntary basis to a mandatory one. © Cambridge University Press 2012. Source

Wild C.,Ludwig Boltzmann Institute for Health Technology Assessment | Patera N.,Ludwig Boltzmann Institute for Health Technology Assessment
European Journal of Cancer Care

To inform the Austrian National Cancer Plan on possible generic quality indicators that might be derived from routine data a systematic literature search in three databases, followed by extensive hand-searching to locate initiatives and their publications was carried out in spring 2011. Twenty-one initiatives that developed indicators for measuring quality of cancer care were identified: longer standing and decentralised initiatives are characteristics of the USA. The Canadian province of Ontario publishes the Cancer System Quality Index, centralised audit and peer review programmes are undertaken in the National Health Service in the UK. Methodologically sound cancer type-specific pilot projects in Belgium have been implemented, the Netherlands and Denmark are running national initiatives. Germany recently started quality measurement activities, too. Generic indicators often focus on end-of-life care, multidisciplinarity, advance care planning and documentation. Indicators measuring the quality of care during an entire episode of cancer are rare, as are those for less common cancers and for care in the outpatient setting. Access, equity and the patient's perspective are only beginning to be incorporated into indicators. After having identified a range of candidate indicators that can be implemented with routinely collected data alone, piloting them in Austria would be the next step to go. © 2013 John Wiley & Sons Ltd. Source

Warmuth M.,Ludwig Boltzmann Institute for Health Technology Assessment | Johansson T.,Paracelsus Medical University | Mad P.,Ludwig Boltzmann Institute for Health Technology Assessment
European Urology

Context: High-intensity focussed ultrasound (HIFU) is an emerging minimally invasive treatment option for prostate cancer. Objective: Our aim was to assess the efficacy and safety of HIFU in both primary treatment of men with localised and locally advanced prostate cancer as well as salvage treatment of men with recurrent prostate cancer following treatment failure of radical prostatectomy or external-beam radiation therapy. Evidence acquisition: We conducted a systematic literature search for studies conducted on humans and published in either English or German in several databases from 2000 to 2010. In addition, we screened several Web sites for assessments on HIFU in prostate cancer and contacted the manufacturers of the two currently available HIFU devices for supplemental information on HIFU. We included all prospective studies with >50 study participants and assessed their quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Evidence synthesis: We identified 20 uncontrolled prospective case series, each of which treated between 58 and 517 patients. These studies were all conducted within the past decade. In total, 3018 patients were treated with HIFU, 93% for primary therapy and 7% for salvage HIFU. For all HIFU procedures, the biochemical disease-free survival rate at 1, 5, and 7 yr, respectively, was 78-84%, 45-84%, and 69%. The negative biopsy rate was 86% at 3 mo and 80% at 15 mo. Overall survival rates and prostate cancer-specific survival rates were 90% and 100% at 5 yr and 83% and 98% at 8 yr, respectively. Adverse events concerned the urinary tract (1-58%), potency (1-77%), the rectum (0-15%), and pain (1-6%). Quality-of-life assessment yielded controversial results. Conclusions: Applying the GRADE approach, the available evidence on efficacy and safety of HIFU in prostate cancer is of very low quality, mainly due to study designs that lack control groups. More research is needed to explore the use of HIFU in prostate cancer. © 2010 European Association of Urology. Source

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