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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 | Year: 2014

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.


Kisser A.,Ludwig Boltzmann Institute for Health Technology Assessment | Zechmeister-Koss I.,Ludwig Boltzmann Institute for Health Technology Assessment
BJOG: An International Journal of Obstetrics and Gynaecology | Year: 2015

Background Screening for cervical cancer precursors by Papanicolaou cytology is a public health success story; however, its low sensitivity entails unnecessary referrals to colposcopy of healthy women with equivocal (ASCUS) or mild dysplasia (LSIL) cytology. Objective We assessed the accuracy of p16/Ki-67 immuno-testing for triage of low grade cervical cytology. Search strategy We systematically searched Medline, Embase, CRD and Cochrane databases, and handsearched key references. Selection criteria Eligible studies included women with ASCUS or LSIL cervical cytology who had undergone p16/Ki-67 testing and subsequent verification by colposcopy-directed biopsies and histologic analysis. Data collection and analysis We extracted data on patient characteristics and test conduct, diagnostic accuracy measures and assessed the methodological quality of the studies. R software was used to perform a bivariate analysis of test performance data. Main results Five eligible studies were identified. Four of the studies had high risk of bias. In the LSIL subgroup, the sensitivity of p16/Ki-67 testing ranged from 0.86 to 0.98, compared with 0.92-0.96 of high-risk HPV testing (hrHPV); specificity ranged from 0.43 to 0.68 versus 0.19 to 0.37, respectively. In the ASCUS subgroup, sensitivity ranged from 0.64 to 0.92 (p16/Ki67 test) versus 0.91 to 0.97 (hrHPV); specificity ranged from 0.53 to 0.81 versus 0.26 to 0.44, respectively. Authors' conclusions p16/Ki-67 testing cannot be recommended for triage women with ASCUS or LSIL cytology due to insufficient high-quality evidence. Further studies on test performance and the impact of p16/Ki-67-based triage on health outcomes are needed for a definitive evaluation of its clinical utility. © 2014 Royal College of Obstetricians and Gynaecologists.


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 | Year: 2013

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.


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 | Year: 2010

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.


Wild C.,Ludwig Boltzmann Institute for Health Technology Assessment | Patera N.,Ludwig Boltzmann Institute for Health Technology Assessment
European Journal of Cancer Care | Year: 2013

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.


Warmuth M.,Ludwig Boltzmann Institute for Health Technology Assessment | Mad P.,Ludwig Boltzmann Institute for Health Technology Assessment | Wild C.,Ludwig Boltzmann Institute for Health Technology Assessment
Acta Anaesthesiologica Scandinavica | Year: 2012

Background A sufficient plasma level of fibrinogen is critical for the formation of a fibrin clot and haemostasis in both the perioperative setting and in massive haemorrhage. We assessed the efficacy and safety of fibrinogen concentrate substitution in the perioperative setting and in massive haemorrhage. Methods We conducted a systematic literature search for studies conducted on humans and published in either English or German in several databases from 1985 to 2010. In addition, we screened several web sites for assessments on fibrinogen concentrate substitution and conducted a hand search using Scopus. In terms of efficacy, we included all prospective, controlled studies. Concerning safety, we included all prospective studies. Results We identified two randomised controlled trials and two non-randomised controlled studies, which included a total of 74 patients. The studies indicate that the administration of fibrinogen concentrate is associated with improved clot firmness and reduction in the substitution of other blood products such as red blood cells, fresh frozen plasma and platelet concentrates, as well as decreased post-operative bleeding and drainage volume. In addition, fibrinogen concentrate administration has been reported to be safe with regard to thrombosis and thromboembolic complications, as well as mortality. However, the studies identified were of poor quality. Conclusion In conclusion, the results of the available controlled trials suggest that the administration of fibrinogen concentrate was effective and safe. However, because all studies identified were of inadequate quality, these findings need to be confirmed by randomised controlled trials of sufficient size and long-term follow-up. © 2011 Ludwig Boltzmann Institute for Health Technology Assessment Acta Anaesthesiologica Scandinavica.


Zechmeister-Koss I.,Ludwig Boltzmann Institute for Health Technology Assessment | Huic M.,Agency for Quality and Accreditation in Health
British Journal of Ophthalmology | Year: 2012

Background and research question: The authors address the question of whether vascular endothelial growth factor inhibitors (anti-VEGF) lead to better clinical outcomes than current treatments in patients with clinically manifest diabetic macular oedema (DMO), which is the leading cause of vision loss in the working age population in developed countries. Methods: The authors performed a systematic literature search in common databases and compiled the evidence according to the GRADE methodology. The authors analysed clinically relevant improvement of visual acuity, vision-related quality of life and local or systemic adverse events. Results: In a proportion of patients (on average 25%), VEGF inhibitors result in better visual acuity (≥15 ETDRS letters or equivalent) than in patients treated with laser photocoagulation or sham injection. The number of injections required for long-termimprovement aswell as the general long-term efficacy is unknown. The evidence is not sufficient to confirm safety of the products in patients with DMO and does not suggest superiority of a single product. Conclusion: For some patients with DMO, VEGF inhibitors seem to be more effective as a short-term treatment option than alternative therapies. The evidence is not of sufficient quality to confirm safety. Decisions on financing should take into account the high price difference between the products and ongoing research.


Zechmeister I.,Ludwig Boltzmann Institute for Health Technology Assessment | Winkler R.,Ludwig Boltzmann Institute for Health Technology Assessment | Mad P.,Ludwig Boltzmann Institute for Health Technology Assessment
European Spine Journal | Year: 2011

Cervical total disc replacement (CTDR) has been increasingly used as an alternative to fusion surgery in patients with pain or neurological symptoms in the cervical spine who do not respond to non-surgical treatment. A systematic literature review has been conducted to evaluate whether CTDR is more efficacious and safer than fusion or non-surgical treatment. Published evidence up to date is summarised qualitatively according to the GRADE methodology. After 2 years of follow-up, studies demonstrated statistically significant non-inferiority of CTDR versus fusion with respect to the composite outcome 'overall success'. Single patient relevant endpoints such as pain, disability or quality of life improved in both groups with no superiority of CTDR. Both technologies showed similar complication rates. No evidence is available for the comparison between CTDR and non-surgical treatment. In the long run improvement of health outcomes seems to be similar in CTDR and fusion, however, the study quality is often severely limited. After both interventions, many patients still face problems. A difficulty per se is the correct diagnosis and indication for surgical interventions in the cervical spine. CTDR is no better than fusion in alleviating symptoms related to disc degeneration in the cervical spine. In the context of limited resources, a net cost comparison may be sensible. So far, CTDR is not recommended for routine use. As many trials are ongoing, re-evaluation at a later date will be required. Future research needs to address the relative effectiveness between CTDR and conservative treatment. © Springer-Verlag 2010.


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 | Year: 2014

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.


Johansson T.,Ludwig Boltzmann Institute for Health Technology Assessment | Wild C.,Ludwig Boltzmann Institute for Health Technology Assessment
Journal of Telemedicine and Telecare | Year: 2011

We conducted a systematic review of telerehabilitation interventions in stroke care. The following databases were searched: Medline, Embase, DARE-NHSEED-HTA (INAHTA) and the Cochrane Library. Nine studies, all published after 2000, were included in the review. A wide variety of telemedicine interventions in post-stroke rehabilitation care was identified. Four studies had been carried out in the USA, two in the Netherlands, two in Italy and one in China. There were four randomized controlled trials and one qualitative analysis. Four studies used an observational study design/case series. Home-based telerehabilitation interventions showed promising results in improving the health of stroke patients and in supporting caregivers. Telemedicine systems based on a virtual environment for upper extremity exercise can improve the physical health of stroke patients. Health professionals and participants reported high levels of satisfaction and acceptance of telerehabilitation interventions. There was no evidence regarding the effects on resource utilization or cost-effectiveness. Most studies showed promising results, although overall, the quality of the evidence on telerehabilitation in post-stroke care was low.

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