Welcome to the homepage of LBI-HTA !
The LBI-HTA is an acadmic non-profit institute and belongs to the Ludwig Boltzmann Society. At our website we wish to present our research and give support for health care decision-making. Here all of our reports are available for free. For further information please contact the LBI-HTA team.
Wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk
Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. In Europe, there are about 350 000 out of hospital SCAs per year. Mostly, ventricular tachycardia and ventricular fibrillation are the underlying aetiology of SCA, which is claimed to be successfully treated by a novel defibrillation therapy, a wearable cardioverter defibrillator (WCD).
This assessment, performed within the „European Network for Health Technology Assessment“ (EUnetHTA) Joint Action 3, aimed to provide valid data on clinical effectiveness and safety of the WCD. Furthermore, the project intended to elicit patients’ views on aspects regarding their cardiac disease and the WCD therapy as well as to identify neglected outcomes.
According to the published data, no statement can be made about the device effectiveness – further research is needed. Studies suggest that the WCD could be a relatively safe intervention in the short to medium term. However, more data and more adequate reporting of (serious) adverse events are needed in order to establish the device safety. In particular, more data is needed for specific risk stratification of high risk patients in order to further narrow down the wide range of indications for WCD use.
Publication: Decision Support Document No. 103: http://eprints.hta.lbg.ac.at/1109/
Contact: Sabine Ettinger
In addition to the results of the prospective multicentre cohort study on the effectiveness of the outpatient cardiac phase III rehabilitation programme (see part VI), the aim of this report was to compare the costs that occur due to the treatment of cardiovascular diseases of patients who underwent an outpatient cardiac phase III rehabilitation programme (intervention group) and patients who did not receive this phase III (control group).
The data of a total of 164 patients was analysed for this report. On average, the total costs that occurred for patients in the control group were 2,900 euros per patient and 5,099 euros per patient in the intervention group.
Publication: LBI-HTA Project report No. 89: http://eprints.hta.lbg.ac.at/1102/
Contact: Stefan Fischer
In recent years, the European collaboration in health technology assessments (HTAs) on (high-risk) medical devices and procedures has become a major issue of consideration due to weak market authorization and efficacy/safety concerns. This research sought to explore and synthesize the critical points and challenges in the assessment of medical devices in Europe discussed in publications and to analyze a number a selected European HTA reports.
The issues discussed in the recent literature can be summarized in five major critical points. The analyses of HTA reports on 10 selected high-risk medical devices revealed the amount of the redundancies in European HTA production: the number of reports per technology ranged between 5 and 22 reports over a time-span of 10-12 years; ranging between 1-6 reports of the same technology within the same year, sometimes even within the same country (language).
The results strongly support the assumption that the resources of HTA institutes can be used more efficiently. The knowledge gained contributes to the conclusion that there is a need not only to collaborate across borders within the same year but also to build on each other´s assessments of the same technologies over years by using the same format, method, language.
Publication: Rapid Assessment No. 12: http://eprints.hta.lbg.ac.at/1108/
Contact: Claudia Wild
In the last few years, payments from the pharmaceutical industry to physicians and medical institutions are increasingly critically questioned, since evidence suggests that those payments are influencing the the medical profession (e.g. in prescribing). To promote trust, the European Federation of Pharmaceutical Industries and Associations (EFPIA) responded with directives and regulations. The "Transparency Initiative" calls on member companies to disclose "monetary benefits to members of the professional circles and institutions" in year 2015. This information should be accessible to the general public at the respective websites of the pharmaceutical companies. The question that underlies this project report is the following: To what extent were Austrian physicians and medical institutions supported by pharmaceutical companies in 2015 and how transparent are they in the disclosure of the financial benefits? In a systematic analysis, the websites of all PHARMIG member companies (115) were searched for information on financial allocations to Austrian physicians and medical institutions in 2015. For a total of 69 out of 115 PHARMIG member companies, cash-based benefits were found in 2015. 20 pharmaceutical companies stated that they had not made any financial contributions; the rest of the companies did not provide feedback on request. A total of 104.1 million euros from PHARMIG member companies to doctors and medical institutions as well as to clinical research and application observations were made in Austria in 2015. Of this, clinical and post-marketing studies were financed with around 54 million euros (52% of the total financial expenditures), medical institutions and organizations received 27 million euros (26%) and medical doctors 22 million euros (22%). The results also show that Austrian pharmaceutical companies invested approximately 30 million euros in events (conferences, meetings), including the support of the events themselves, conference and participation fees as well as travel and accommodation costs. A total of 14 million euros was spent on services and advisory fees (e.g. lectures from doctors) and about 6 million euros for donations and funding. The disclosure of payments by pharmaceutical companies to doctors and medical institutions in Austria is an important step towards greater transparency, but is still at an initial stage. The evaluation of the data from 2015 shows that the actual willingness to disclose financial grants, especially from physicians, is low and the individual disclosure rate (name of the nominee) was only at an average of 21.9%. In contrast, the willingness to disclose payments from medical institutions by name (institutional) was significantly higher at 50.2%.
Contact: Philipp Petersen
We are pleased to introduce our two new HSO reports.
Health care personnel regularly carrying out invasive procedures have a higher risk for exposure with HCV positive blood through needle stick injuries The aim of this study was to analyse the appropriateness of preoperative/preinterventional HCV testing in patients using available data on the prevalence and transmission risk and in comparison to international guideline recommendations.
Recent national and international reports were retrieved for estimates of HCV prevalence and incidence in Austria. Data on hepatitis C as an occupational disease were provided by the AUVA. We defined the factors influencing the patient- provider transmission risk and systematically searched the literature for studies on transmission risk and guidelines with recommendations on HCV screening or transmission prevention.
The effectiveness of HCV-tests in patients to prevent infections in HCW or even reduced needle-stick injuries is not supported by evidence. Current guidelines recommend to universally apply precautions to minimise needle stick injuries. Recommendations on preoperative HCV screening prior to elective surgeries are based on expert consensus: no clinical studies could be identified that analysed the effectiveness of the testing on infection prevention.
Publication: Decision Support Document No. 102: http://eprints.hta.lbg.ac.at/1103/
Contact: Agnes Kisser
Outpatient cardiac rehabilitation part VI: prospective multi-centre cohort study (comparing patients with and without phase III)
In 2012, we published the study protocol of a prospective multi-centre cohort study (http://eprints.hta.lbg.ac.at/971/) that aimed at comparing patients who attended an outpatient phase III cardiac rehabilitation after phase II with patients who did not. We defined the mean between group difference of risk factors out of the target range at the end of the observation period as the primary outcome. Now, we report on the results: 16 months after Phase II Rehabilitation, this (adjusted) mean difference was -0,06 [-0.7; 0.6] (non-significant). Roughly spoken, about one out of twenty IG patients (6 of 100) of the sample showed one risk factor out of the target range less than a KG patient. In secondary endpoints, only the change in the exercise stress test (percental increase) and the frequency of inpatient re-rehabilitation showed a statistically significant group difference in favour of the intervention. The higher than expected drop-out should be considered when interpreting the results.
Publication: LBI-HTA Project report No. 90: http://eprints.hta.lbg.ac.at/1101/
Contact: Brigitte Piso