LBI Health Technology Assessment

Horizon Scanning in Oncology: Decision Support Document No. 36 online (13.06.2013)

Within the scope of the Horizon Scanning in Oncology project, the LBI-HTA periodically publishes assessments on novel cancer drugs with a likely therapeutical and/or financial outcome. These assessments serve as decision aids for funding agencies and the decision-making network "HTA in hospitals " alike.

June 2013:
Trastuzumab emtansine (KadcylaTM) for previously treated patients with
HER2-positive advanced/ metastatic breast cancer New!

Horizon Scanning in Oncology: Decision Support Document No. 37 online (10.06.2013)

June 2013:
Enzalutamide (Xtandi®) for patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy New!

Re-orientation of the Austrian parent-child preventive care programme. Part IX: Recommendations from evidence-based guidelines for screening measures during pregnancy and early childhood (0-6 yrs.) (14.05.2013)

Part IX of the project “Re-orientiation of the Austrian parent-child preventive care programme“ provides a comprehensive, systematic review of screening recommendations from evidence-based guidelines during pregnancy, puerperium and early childhood.
A systematic search in 2 guideline databases was supplemented by a comprehensive hand search on the web pages of international institutions that develop evidence-based guidelines. The inclusion criteria particularly focused on the methodological quality of the guidelines.
We included a total of 138 guidelines and extracted recommendations concerning 92 health threats.
The screening recommendations of the institutions (in their original wording) were complemented by additional information from the guidelines (concerning screening methods, treatment options and potential harm). All included guideline recommendations were consequently assigned to 5 categories.
The guideline synopsis (“assessment“) can be used as decision support for the re-orientiation of the parent-child preventive care programme in Austria. The policy decision on the implementation of new measures, respectively, the adaptation of existing approaches, requires the “appraisal“ of the provided evidence-base that has to take account of the limitations outlined in the report.

LBI-HTA Projectreport No. 62: http://eprints.hta.lbg.ac.at/996/

Contact: Brigitte Piso

Hybrid operating room (18.04.2013)

A hybrid operating room is a surgical theatre that is equipped with advanced medical imaging devices such as fixed computertomography/CT, Magnetresonancetomography/MRT and angiography. Hybrid operating rooms are currently used mainly in cardiac, vascular and neuro-surgery, but could be suitable for a number of other surgical disciplines. The actual use of (highly expensive) hybrid operating room is very much defined by the mandate of its use and is characterized by the interdisciplinary culture and work-organisation of a clinic.

Rapid Assessment No. 06: http://eprints.hta.lbg.ac.at/995

Contact: Claudia Wild

Horizon Scanning in Oncology: Decision Support Document No. 35 online (21.03.2013)

March 2013:
Crizotinib (Xalkori®) for the treatment of anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) New!

Marketing Authorisations under Exceptional Circumstances for Oncology Drugs (20.02.2013)

This report aims to provide insight into the authorisation under exceptional circumstances of oncology drugs.
Clinical data used by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for granting exceptional circumstances and additional requirements to be fulfilled by the marketing authorisation holder were identified via EMA’s homepage. For any additional data which had become available on the originally licenced indication after market authorization a literature search on MEDLINE was performed and decisions of selected reimbursement agencies on drugs licensed under exceptional circumstances were elicited from the respective agencies’ homepage.
Four oncologic drugs are currently licensed under exceptional circumstances; clofarabine, nelarabine, trabectedin and histamine dihydrochloride. Histamine dihydrochloride was the only drug tested in a phase III trial. For clofarabine, nelarabine and trabectedin the justification for the authorisation under exceptional circumstances was the small size of the patient population. For histamine dihydrochloride it was unclear. Most of the additional requirements by the CHMP considered safety measures and additional requirements were not always completed within the set time-frame.
The methods of the reimbursement assessments varied. One patient access scheme was identified for trabectedin in England. Some drugs were not accessible in some countries and for others it was unclear.
To successfully develop drugs for very rare conditions, it is important that industry, EMA and reimbursement agencies intensify the collaboration. On introduction these drugs cannot always prove their cost-effectiveness, therefore conditional coverage with evidence development, preferably on an international level, should be encouraged and facilitated.

LBI-HTA Projektbericht Nr. 65: http://eprints.hta.lbg.ac.at/992/

Kontakt: Anna Nachtnebel

Screening for Colorectal Cancer. Part 3: Status screening-activities and quality assurance of screening-colonoscopy (18.02.2013)

Colorectal cancer/CRC-Screening has the potential for both early detection and prevention. Colonoscopy is a possible first-line test and the final common pathway of all screening-strategies.
For this report guidelines and position papers on quality assurance in CRC-screening with a particular focus on screening-colonoscopies were searched and the major stakeholders in Austria contacted.
Organized CRC-screening programs in Australia, England, Finland, France, Italy, Poland, Scotland and Slovenia are briefly presented. Participation rates effectively observed in real life CRC-screening programs vary considerably. They tend to be higher with FOBT (gFOBT 37-66%, iFOBT 17-48%) than with flexible sigmoidoscopy (24%) and colonoscopy (18-24%).
For quality assurance of screening-colonoscopy an established range of quality measures is available. The comprehensiveness of indicators and the defined target ranges of measures endorsed by national and international institutions vary, though.
Even if quality assurance is made mandatory in the context of opportunistic screening, it cannot match the stringent and comprehensive quality focus of organized screening-programs. Examples of how to plan and organize quality assurance in population-based CRC-screening programs is available. Interesting models to learn from can for instance be found in England, in the Netherlands and in Norway.

LBI-HTA Project Report No. 41c: http://eprints.hta.lbg.ac.at/983

Contact: Nikolaus Patera

Job vacancy at the LBI-HTA (25.01.2013)

The text of this advertisement is only available in German because a very good knowledge of the German language is prerequisite for fulfilling the job requirements.

Avastin for Age-related Macular-Degeneration. Evidence synthesis after CATT, IVAN, MANTA (22.01.2013)

The objective of the rapid assessment was to summarize once again the synthesis of evidence on the efficacy and safety of Bevacizumab: Avastin is currently the best examined off-label drug in the world. 132 prospective cohort studies on the intravitreal application of Avastin were published up to July 2010 alone; since the publication of now three head-to-head, randomized clinical studies / RCTs (CATT, IVAN, MANTA), evidence meeting the highest methodological requirements is available. The efficacy is regarded – not least by these RCTs – as proven.

As Avastin for AMD is an off-label use, the reactions of the authorities of the European Member States pursuant to the legislation are very homogeneous, as the legal interpretation is referred to. Less homogeneous is the legal interpretation and the – in the EU Member States very different – dealing with off-label applications: In Holland the Health Ministry even suggested recently (August 2012) (based on CATT and IVAN findings, as well as a national health economic assessment) to completely do without the approved Lucentis in the benefits catalog, resp., to keep Lucentis only as a derivative drug for those patients who react to Avastin with intolerances. A decision remains to be made here.

Rapid Assessment Nr. 05. 2012: http://eprints.hta.lbg.ac.at/989/

Contact: Claudia Wild

Health status and access to health care of homeless people: A literature review (14.01.2013)

The poor living conditions of homeless people result in increased risk of illness. At the same time, medical care is assumed to be inadequate. The aim of the project was to systematically analyse the published literature on the health status, barriers to health care and utilisation patterns of homeless people in urban areas. The extensive amount of literature shows that homeless people suffer from a broad spectrum of diseases. Apart from a disproportionally high prevalence of mental disorders, a number of somatic problems (lead by infectious diseases and low oral health) exist, resulting in long-term ill-health and other consequences (e.g., premature death). Homeless people have frequently contact with the health care system, however, they tend to receive inadequate services and treatment. Utilisation of health services is dependent on type of health care system, sex and type of homelessness. Often, they are confronted with formal or informal barriers to access. This on the one hand demonstrates the need for needs-based services at the primary care level that are organised in an interdisciplinary manner. On the other hand strategies which both tackle the causes of ill-health and focus on health determinants are required.

LBI-HTA Project Report No. 63: http://eprints.hta.lbg.ac.at/980/

Contact: Ingrid Zechmeister-Koss

Horizon Scanning in Oncology: Decision Support Document No. 34 online (11.01.2013)

January 201:
Trametinib for advanced or metastatic BRAF V600 mutation-positive melanoma Neu!

Efficacy of Hyperthermia treatment in combination with radio- or chemotherapy in Breast-, Bladder-, Cervix carcinoma and Soft tissue sarcoma patients (10.01.2013)

The objective of this review was to synthesize the evidence on efficacy of hyperthermia in combination with radio- or chemotherapy in breast-, bladder-, cervix carcinoma and soft tissue sarcoma patients. The report is based on 2 previous systematic reviews a systematic literature search in 4 databases with identical search terms was carried out in order to find randomized clinical trials. 2 RCTs for breast cancer, 2 RCTs for bladder cancer, 3 RCTs for cervix carcinoma, 1 RCT for bladder and cervix and 1 RCT for soft tissue sarcoma were found. Overall, of the 1265 patients 656 were allocated to receive treatment with hyperthermia in combination with radio- or chemotherapy. Where CR or PR was assessed (in 6 from 9 trials) hyperthermia showed statistical significant outcomes. Some of the trials assessed DFS (3/9) or PFS (2/9): all of them show superiority of the hyperthermia arm. Of the 9 publications providing OS data only 1 shows a statistical significant improvement in overall survival, thus proposing that the surrogate endpoints do not translate into a survival benefit and hyperthermia leads to temporal effects only. QoL was not assessed in any of the trials. The reporting of safety data was consistent across the studies showing a trend towards an inferior safety profile within the hyperthermia arms.

DSD Nr. 36/Update 2012: http://eprints.hta.lbg.ac.at/986/

Contact: Claudia Wild

Day Surgery (10.01.2013)

The present report provides an overview of the landscape of day surgery in Austria and the best available evidence of effectiveness and safety for eleven different day surgical operations. The analysed interventions were: cataract surgery, curettage, arthroscopic operations of knee, vein ligation, cholecystectomy, adenoidectomy, paracentesis, decompression of median nerve, repair of inguinal or femoral hernia, removal of implanted devices of bones and appendectomy. We identified 35 relevant studies through a systematic literature search that was complemented by an unsystematic hand search. On the basis of the studies summarised, we conclude that six out of the eleven operations can be done safely (and effectively) in both a day surgery as well as an inpatient setting in those patients who fulfil the eligibility criteria for day surgery. For the other five interventions more studies with a higher level of evidence are required, even though these operations are already undertaken in a day surgery setting in many countries.

HTA Project Report Nr. 64: http://eprints.hta.lbg.ac.at/987

Contact: Stefan Fischer

Therapeutic hypothermia (TH) (23.11.2012)

The present report provides an overview of the best available evidence of therapeutic hypothermia for eleven different indications in adults, including cardiac arrest, stroke, traumatic brain injury, spinal cord injury, cardiogenic shock, refractory fever, sepsis, meningitis/meningoencephalitis, convulsive status epilepticus, acute liver failure and acute renal failure. We identified 14 relevant studies through a systematic literature search that was complemented by an unsystematic hand search and a search in study registries. While the evidence indicates that therapeutic hypothermia is efficacious and safe in one of eleven indications (cardiac arrest), it appears to be safe in stroke but efficacy remains to be shown. For all other indications both the efficacy and safety remain to be proven. Therapeutic hypothermia represents a dynamic field of research, which can be seen in the great amount of finished or ongoing clinical studies. Hence, the evidence base may change for a couple of indications in the near future. The routine use of therapeutic hypothermia outside of clinical trials is not recommended.

DSD Nr. 63: http://eprints.hta.lbg.ac.at/985/

Contact: Marisa Warmuth

Horizon Scanning in Oncology: Decision Support Document No. 33 online (08.11.2012)

November 2012:
Lenalidomide (Revlimid®) for the first-line therapy of transplant-ineligible patients with multiple myeloma New!

Screening for Colorectal Cancer (31.10.2012)

Part 1: Screening Tests and Program Design
(3. updated edition)

Four randomized controlled trials on screening for faecal occult blood (gFOBT) as a first-line test showed a relative risk reduction of 15% for disease-specific CRC-mortality. Three large non-population based randomized controlled trial on flexible sigmoidoscopy as a first-line screening-test showed a relative risk reduction of 31%, 26% and (statistically not significant) 22% for disease-specific CRC-mortality. Two randomized studies on screening with either colonoscopy or iFOBT as a first-line test will yield results ten years from now. The ideal test strategy in CRC-screening is uncertain, the evidence base evolving.

LBI-HTA Project Report No. 41a: http://eprints.hta.lbg.ac.at/981

Contact: Nikolaus Patera

Part 2: Health economic evaluations and
cost dynamics (2. updated edition)

This report summarizes the results of economic evaluations of cost-effectiveness of CRC-screening (5 systematic reviews, 31 primary economic evaluation studies). The incremental cost-effectiveness ratios (ICERs) of below € 20.000.- per life year gained found for most screening strategies are acceptable compared to the alternative of “no screening”. From this perspective the introduction of CRC-screening for people 50-74 years of age with average risk for CRC is justifiable as long as screening is systematically quality assured.

LBI-HTA Project Report No. 41b: http://eprints.hta.lbg.ac.at/982

Contact: Nikolaus Patera

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Universal HIV-Testing. International Recommendations and actual risk of HIV-Infections for Healthcare-Workers (05.10.2012)

Austria has the highest HIV-test rate per 1,000 inhabitants in the European Union: 99 tests per 1,000 inhabitants compared to the EU-average of 45.3 in 2010. This may be related to beliefs held by the health care personnel that knowledge of the HIV-status of a patient (e.g. via routine pre-operative testing) serves as a protective measure against occupational transmission of HIV.
In order to identify national and international guidelines on universal HIV-testing as well as literature on the actual infection risks for health care personnel, websites and databases were hand-searched.
International guidelines tend to recommend universal screening for HIV in all health-care settings only when the undiagnosed prevalence of HIV is >0.1%. Pre-operative screening is either not mentioned or explicitly not recommended.
HIV poses a small but real risk to health-care personnel. Since the beginning of counting until 2002, 106 cases of occupational HIV-infections have been documented worldwide: in Austria there have been 4 cases of occupational HIV-infection between 1996 and 2011. There is no convincing evidence that knowledge of the serostatus of a patient leads to changes in the behaviour of health-care workers.
With an HIV-prevalence of about 0.1%, Austria is considered to be a low-prevalence country. Based on international guidelines, universal HIV-testing is not advisable in Austria.

Decision Support Document No. 61: http://eprints.hta.lbg.ac.at/979

Contact: Claudia Wild

Horizon Scanning in Oncology: Decision Support Document No. 31 online (26.09.2012)

September 2012:
Pertuzumab (Omnitarg/Perjeta®) for the first-line therapy of metastatic HER2 positive breast cancer New!

Horizon Scanning in Oncology: Decision Support Document No. 32 online (24.09.2012)

September 2012:
Everolimus (Afinitor® or Votubia®) in Kombination mit Exemestan zur Therapie des Hormonrezeptor-positiven, HER2/neu-negativen, fortgeschrittenen Mammakarzinoms bei postmenopausalen Frauen, nach Rezidiv oder Progression nach Letrozol oder Anastrozol Neu!

Horizon Scanning in Oncology: Decision Support Document No. 29 online (12.09.2012)

September 2012:
Bortezomib (Velcade®) as consolidation or maintenance therapy after autologous stem-cell transplantation in patients with newly diagnosed multiple myeloma New!

Occupational therapy Part I Status quo in Austria and Part II: Occupational therapy for rheumatoid arthritis (11.09.2012)

Part I:
Part I gives an overview of the current situation of occupational therapy in Austria:
We identified different definitions of “occupational therapy”. The differentiation between occupational therapy services and other therapeutic services, e.g., physiotherapy, is challenging due to its numerous indications and different therapeutic measures.
The education in Austria takes place at universities and is standardised according to international standards.
There is no mandatory registration for occupational therapists in Austria. Hence, the overall number of therapists is estimated by the “MTD–Dachverband” on 1.446 therapists.

Part II:
The systematic review is based on the latest Cochrane Review “Occupational therapy for rheumatoid arthritis” published in 2004. We added the results of RCTs published since 2003 to the previous Cochrane results. A systematic literature search in various databases (Cochrane, CRD, Embase, Medline, OT Seeker) was supplemented by a non-systematic hand search. We included RCTs in English and German.
We identified 197 references (years 2003-2011). In addition to the Cochrane Review, 8 RCTs were included in the review.
There is strong to limited evidence for the effectiveness of occupational therapy on the outcomes of functional ability, pain, and grip strength. There is a lack of evidence concerning other outcomes and categories of occupational measures.

LBI-HTA Project Report No. 56: http://eprints.hta.lbg.ac.at/972/

Contact: Brigitte Piso

Occupational Therapy Part III. Occupational therapy for patients after stroke (11.09.2012)

Stroke is the third leading cause of death in Austria after cardiovascular diseases and cancer, and often leads to functional and cognitive impairment and chronic disability in survivors. Approximately one-third of the patients surviving a stroke remain dependent on their caregivers. The central aim of occupational therapy for stroke patients is to achieve the maximum degree of autonomy, above all by improving activities of daily living (ADL) and participation in social life.
Part III of the project on occupational therapy analysed the efficacy of occupational therapy interventions with the focus on activities of daily living and on cognitive impairments for patients after stroke, compared to no intervention or routine care.
The systematic review is based on 2 Cochrane Reviews published in 2006 and 2010 respectively, and added results from recent RCTs identified through a systematic literature search and a hand search. A total of 4 RCTs could be identified that fulfilled the inclusion criteria.
Despite the lack of evidence for some outcomes and for interventions focused on cognitive impairments, the results indicate that occupational therapy focused on ADL training leads to a significant improvement of several outcomes in patients after strokes.

LBI-HTA Project Report No. 59: http://eprints.hta.lbg.ac.at/973/

Contact: Inanna Reinsperger

Occupational Therapy Part IV for Dementia and Part V for Depression (11.09.2012)

Part IV analyzes evidence for the effectiveness of occupational therapy for patients suffering from dementia. A (single) recent and comprehensive review of the evidence for occupational therapy’s effectiveness for patients with Alzheimer and related dementias was available. Most of the evidence on occupational therapy is from the inpatient sector and shows that certain occupational therapy interventions may tend to have certain positive effects on patients and their (family) caregivers. It is unclear which occupational therapy interventions are the most effective and how often they have to be performed in order to achieve a given effect.

Part V analyzes the evidence on the effectiveness of occupational therapy interventions for depressed patients. There is only scant high level evidence on the effectiveness of occupational therapy on depression. In answer to our research question all three included systematic reviews refer to one identical RCT. This RCT on severe depression at the workplace is small but of good methodological quality. It shows no improvement of depression through occupational therapy interventions but finds a faster return to the workplace in the intervention group. This appears to be quite straight forward evidence for a positive effect of an occupational therapy program. In addition a feasibility study for an RCT with aged inhabitants of nursing homes finds no significant differences in depression, dependence on caregivers and quality of life. This result needs to be viewed with caution due to the poor quality of the study. Available evidence is too little, too specific and of insufficient methodological quality to justify more general conclusions on the effectiveness of occupational therapy with persons with depression.

Project Report Nr. 60: http://eprints.hta.lbg.ac.at/974

Contact: Nikolaus Patera

Outpatient cardiac rehabilitation. Part V: Study protocol Multi-centre, prospective cohort study with two control groups (with/ without phase III) (10.09.2012)

Six- to twelve-month outpatient cardiac phase III rehabilitation following phase II is currently provided at a few sites in Austria. Eight outpatient cardiac rehabilitation centres currently have temporary contracts with the Association of Austrian Health Insurance Providers. Based upon preliminary work (Outpatient cardiac rehabilitation parts I-IV) a multi-centre, prospective cohort study with two control groups (with/ without phase III) will be conducted. The primary research question of the study is: Do patients with disadvantageous risk profile who attend an additional phase III program after phase II have at mean less risk factors out of the target area compared to patients without phase III 18 months after end of phase II? A total of 450 patients will be included. In addition to clinical parameters a patient questionnaire will be handed out. 18 month after the end of phase II all patients will receive a patient questionnaire again as well as a doctor´s questionnaire. This questionnaire will be filled in by the internal specialist of each patient (alternative by an internal specialist of an outpatient clinic owned by sickness funds). The total study duration will be approximately three years.

Decision Support Document No. 50: http://eprints.hta.lbg.ac.at/971

Contact: Brigitte Piso

Extracorporeal shock wave therapy (ESWT) in non-union or delayed union of fractures (09.09.2012)

Extracorporeal shock wave therapy (ESWT) was introduced in 1980 for the non-invasive disintegration of kidney stones. Since the early 1990s, it has been used for the treatment of delayed union and non-union of fractures. This systematic review aims at summarising the evidence concerning the efficacy and safety of this treatment option in delayed union or non-union of fractures.

In terms of efficacy, currently the evidence is based on one randomised controlled trial. However, concerning safety, we identified another nine prospective, uncontrolled case-series. Besides efficacy outcomes, such as union rate, time to fracture union, function, pain and quality of life, we report safety outcomes like major and minor adverse events.

In conclusion, there is a lack of evidence, particularly in terms of efficacy of ESWT for the treatment of delayed union or non-union of fractures. It is recommended to conduct prospective, (randomised) controlled trials and take into consideration some aspects that will be further discussed in in this review.

Decision Support Document No. 62: http://eprints.hta.lbg.ac.at/975

Contact: Marisa Warmuth

Horizon Scanning in Oncology: Decision Support Document No. 30 online (31.07.2012)

July 2012:
Ipilimumab (Yervoy®) for the first-line therapy of advanced/metastatic cutaneous melanoma New!

June 2012:
Romidepsin (Istodax®) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) after prior systemic therapy  New!
Brentuximab (Adcetris®) for the treatment of relapsed Hodgkin’s lymphoma (HL) or relapsed systemic anaplastic large cell lymphoma (sALCL)  New!
Lenalidomide (Revlimid®) for the treatment of low /intermediate-1 risk myelodysplastic syndrome with chromosome 5q deletion   New!

Evaluation of individual medical services 2012 (27.07.2012)

Each year, the Austrian Ministry of Health receives suggestions for numerous new medical interventions to get reimbursed. The aim of this project is to evaluate the efficacy and safety of interventions, suggested to be included into the MEL (German for: individual medical services) catalogue. Themes (interventions) were prioritized by the Ministry of Health and contracted out to the LBI-HTA. The assessments are based on systematic reviews for each intervention and a summary of the scientific evidence according to the GRADE scheme. Since 2009 there is a cooperation with the german NUB process, which also appraises with the same method for both countries relevant new medical interventions at the same time.

8 Decision Support Documents 2012:

DSD 53: Radiofrequency ablation of tumors of the lung and mediastinal lymph nodes
http://eprints.hta.lbg.ac.at/957/
DSD 54: Radiofrequency ablation of bone tumors (osteoid-osteoma and osseous metastases)
http://eprints.hta.lbg.ac.at/958/
DSD 55: Radiofrequency Ablation for Treatment of Head and Neck Cancer
http://eprints.hta.lbg.ac.at/959/
DSD 56: Radiofrequency Ablation for Treatment of Benign and Malignant Lesions of Endocrine Organs (Thyroid and Adrenal Gland)
http://eprints.hta.lbg.ac.at/960/
DSD 57: Radiofrequency Ablation for Treatment of Breast Cancer
http://eprints.hta.lbg.ac.at/961/
DSD 58: Radiofrequency ablation of primary tumors of the gastrointestinal tract (colorectal and pancreatic cancer)
http://eprints.hta.lbg.ac.at/962/
DSD 59: Radiofrequency Ablation for Treatment of Tumors of the Urogenital Tract (Renal Cell Carcinoma, Prostate Cancer and Uterine Leiomyoma)
http://eprints.hta.lbg.ac.at/963/
DSD 60: Sling suspension in male urinary incontinence
http://eprints.hta.lbg.ac.at/964/

+ 4 Updates:

DSD 06/ Update 2012: Cell therapy for urinary stress incontinence
http://eprints.hta.lbg.ac.at/965/
DSD 23/ Update 2012: Intraoperative radiotherapy for primary breast cancer
http://eprints.hta.lbg.ac.at/966/
DSD 41/ Update 2012: Percutaneous repair of mitral regurgitation with the MitraClip
http://eprints.hta.lbg.ac.at/967/
DSD 45/ Update 2012: Renal denervation in patients with essential hypertension
http://eprints.hta.lbg.ac.at/968/

Contact: Claudia Wild

Horizon Scanning in Oncology Impact- und Umfeldanalyse (27.07.2012)

The programme “Horizon Scanning in Oncology” (HSO) evaluates anti-cancer therapies prior to their routine introduction into clinical practice in order to inform decision-makers.
The objective of this report is to evaluate the impact of this programme using a download analysis and an online survey and to conduct an environmental analysis.
In general there are indications for an impact of HSO: the reports are increasingly downloaded and are considered as a relevant, timely and high-quality information source. The environmental analysis showed that the LBI-HTA is with its early assessments of anti-cancer drugs amongst the earliest institutes publishing reports, on average, within 4 months after the European Medicines Agency approval. Nevertheless, several questions remain unanswered, as, for example, do the HSO documents actually have an influence on decisions or why do clinicians use this source less often?

LBI-HTA Project Report No. 61: http://eprints.hta.lbg.ac.at/969/

Contact: Anna Nachtnebel

Re-orientation of the Austrian parent-child preventive care programme: Update Part I and IV (incl. Addendum) (26.07.2012)

Since the publication of project reports, "Re-orientation of the Austrian parent-child preventive care programme new," Parts I and IV in March 2011, there was evidence of missing especially Austrian data regarding the frequency of specific health threats. Additional data was compiled by a questionnaire send out in December 2011 in which experts had the opportunity to indicate additional references and Austrian data sources.
We received additional information concerning seven health threats. Accordingly, the following chapters of Part I were revised or supplemented: Fetal tobacco syndrome, toxoplasmosis, cerebral palsy, metabolic disorders, hip dysplasia, developmental language disorders and diabetes mellitus. The frequency tables at the end of the chapter and the "ranking" of health threats in Part IV have been also revised accordingly.

The update, however, relates exclusively to the aforementioned chapter, all other parts of the report are unchanged and the final state of the first publication (March 2011).

Horizon Scanning in Oncology: Decision Support Documents No. 25, 26 & 28 online (13.06.2012)

June 2012:
Romidepsin (Istodax®) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) after prior systemic therapy New!
Brentuximab (Adcetris®) for the treatment of relapsed Hodgkin’s lymphoma (HL) or relapsed systemic anaplastic large cell lymphoma (sALCL) New!
Lenalidomide (Revlimid®) for the treatment of low /intermediate-1 risk myelodysplastic syndrome with chromosome 5q deletion New!

Quality Appraisal of Written Consumer Health Information for Patients with Chronic Myeloid Leukaemia (CML) (25.05.2012)

This LBI-HTA project report addresses the quality appraisal of existing written consumer health information (CHI) materials for patients suffering from chronic myeloid leukaemia (CML). Freely available and easily accessible (e.g. via the internet) written consumer health information (CHI) plays an increasingly important role in the treatment decision process between patients and their health-care professionals. Criteria describing the quality of CHI have already been defined. However, there is criticism that they are not yet comprehensively addressed within existing CHI. This study aims at assessing the quality of written CHI about treatment options for chronic myeloid leukaemia (CML). The included patient information materials was assessed with the standardised quality appraisal instrument DISCERN. The results confirm that available CHI does not sufficiently meet existing quality criteria for patient information. Especially materials offered by commercial organisations have significantly lower DISCERN ratings than those offered by non-profit organisations. Astonishingly, materials of providers approved by quality labels such as Health-on-the-Net (HON), which claim to set apart trustworthy from non-trustworthy websites (e.g. potential for commercial influence), do not demonstrate higher quality than materials by providers without any quality labels.

LBI-HTA Project Report No. 052: http://eprints.hta.lbg.ac.at/953
Contact: Katharina Hintringer

Horizon Scanning in Oncology: Decision Support Document No. 27 online (24.05.2012)

May 2012:
Bevacizumab (Avastin®) in combination with chemotherapy in previously treated metastatic breast cancer New!

Re-orientation of the Austrian parent-child preventive care programme, Part VI: Health visiting services in the context of health care programmes for pregnant women, parents and children (22.05.2012)

Within the context of the LBI-HTA project ‘Re-orientation of the Austrian parent-child preventive care programme’, this report dealt with outreach services for expectant mothers, parents and children. The goal of this study was to give a selected country overview of training, advanced training and professional profiles of outreach services, to provide evidence of the efficacy of outreach services along target group-relevant outcomes for expectant mothers, parents and children, and to illustrate a status quo survey of outreach offers in Austria. Concerning the training options for outreach services, it turned out that there are particular modules preparing for the work with socially deprived target groups in Germany and Austria, whereas there are more general training options in Great Britain, Denmark and Sweden. The literature overview (based on 6 reviews) dealing with the efficacy of outreach services showed evidence for a positive influence on the physical and mental health of children and mothers. In addition, a positive impact of outreach services was also stated regarding mother/parent-child interactions and the number of child accidents. The survey on outreach services in Austria showed that the main tasks of health visitors focus on parents’ counselling and support. Furthermore, most outreach programmes target socially deprived families. Social workers, psychologists and certified health care personnel were the groups most often mentioned by the survey participants.

HTA Project report No. 053: http://eprints.hta.lbg.ac.at/947
Contact: Roman Winkler

Re-orientation of the Austrian parent-child preventive care programme, Part VII: Potential of an electronic implementation (22.05.2012)

Aim of part VII was to identify international, electronically-realised initiatives and to analyse the feasibility of an electronic parent-child initiatives (EKVI) as an Austrian electronic health record (ELGA) application. Nearly all (paper-based or electronic) EKVI follow four objectives: health care provision, administration of health care provision, quality through equal access and structured health care provision, processing of benefits payments. Beyond that, electronic EKVIs enable health services research and planning, evaluations, as well as decision-making support for appropriate levels of care. In practice, the path from local (surgery or hospital) systems to integrated, contact point-spanning health records/ ELGA for maternity and infancy appears to still not be fully developed everywhere. Several core aspects could be identified from the first reports as best practice recommendations for a successful planning and implementation of eEKVIs. The analysis of concrete application cases based on the current Mother-Child-Pass showed that - under the preconditions of a functioning framework architecture of ÖELGA, a secured legal situation and a consensus (resp. a legal obligation) of the actors to participate- the realisation in ÖELGA is technically solvable. The substantive reorientation of an ÖMKP is to be initially discussed irrespective of the type of personal health record (electronic or paper-based). Once a broad-based consensus on new objectives (e.g.: universal vs. risk group-specific health care provision offers) exists, the next step would be to develop a suitable form of implementation. The electronic implementation should thereby be an action field in the “Austrian e-Health Strategy”. An implementation of an Austrian eMKP should be planned in realistic time frames, field-tested in the form of regional pilot projects with the involvement of the users, and developed with the possibility for subsequent optimisations.

HTA Project report No. 054: http://eprints.hta.lbg.ac.at/948
Contact: Claudia Wild

Re-orientation of the Austrian parent-child preventive care programme. Part VIII: Review of economic evaluations and budget impact analysis of measures to reduce premature birth and outreach services (22.05.2012)

Within the context of the LBI-HTA project ‚Re-orientation of the Austrian parent-child preventive care programme’, this report (part VIII) dealt with the immediate financial consequences for public payers (budget impact) that are associated with the introduction of measures to reduce premature births and outreach services in Austria.
Depending on the type of programme, programme costs for measures to reduce preterm births varied between < 50,000 € and 2 Mio. €. In the majority of scenarios analysed, potential cost-savings outweigh expected programme costs. From an efficiency perspective, the “cervix screening + progesterone” and the “vaginal infection screening” programmes appear superior to the “progesterone injection”, “fish oil” and “smoking cessation” programmes.
Similarly, cost-savings in the hospital sector due to outreach services following early discharge after normal birth seem to outweigh programme costs. Outreach services in early childhood are most expensive with a lower likelihood for (economic) benefits. However, among all programmes analysed they are the only ones that primarily tackle health inequalities.

HTA Project report No. 055: http://eprints.hta.lbg.ac.at/949
Contact: Ingrid Zechmeister-Koss

Generic indicators for process quality in oncological care: A compendium (24.02.2012)

LBI-HTA published the report “Quality of care in oncology and its measurement” in 2011 where international efforts in indicator development are discussed. Therein 17 indicator sets for measuring quality in oncological care were presented as examples. In order to give clinical practice a hands on tool book in the area of cancer care quality indicators, this compendium provides details about generic (i.e. not cancer type specific) process indicators (i.e. not structure or outcome) from this pool of 17 oncological indicator sets.

The focus of this compendium lies on processes after a confirmed diagnosis of cancer. Therefore indicators for preventive care including screening are not covered. Five of the 17 indicator sets did not contain any generic process indicators. All generic process indicators found are listed. 31 generic process indicators that were found in at least two of the 17 indicator sets are described in greater detail in this compendium.

HTA-Project report No. 049b: http://eprints.hta.lbg.ac.at/946
Contact: Nikolaus Patera

Horizon Scanning in Oncology: Decision Support Document No. 21 online (17.02.2012)

February 2012:
Axitinib (AG013736, Inlyta®) for the second-line treatment of metastatic renal cell carcinoma (mRCC) New!
Erlotinib (Tarceva®) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations
Everolimus (Afinitor®) for the treatment of unresectable or metastatic neuroendocrine tumours of pancreatic origin

LBI-HTA Annual Report 2011 (13.02.2012)

The LBI-HTA presents its sixth annual report. Besides the detailed description of the Institute in regard to its budget, institutional partners and committees, this report also includes an overview of LBI-HTA's completed and newly launched research projects in 2011. Moreover, the annual report provides key aspects of the Institute’s activities, such as publications of LBI-HTA researchers, their participation in scientific conferences, trainings, teaching and review activities as well as national and international scientific cooperations.

Highlights and challenges in 2011 included the active participation in the EU project "EUnetHTA Joint Action (1) 2010 to 2012" (as lead partner of work package 7B) and the development of a database of all planned and ongoing assessments of the EUnetHTA partner organisations (POP database), application and approval of a further EU-project “Joint Action (2) EUnetHTA 10/2012 to 09/2015” in which the LBI-HTA will again take on a prominent position, namely as a WP co-leader, the successful piloting of several international cooperation projects within the Horizon Scanning in Oncology program and within the annually performed evaluations of hospital intervention, the successful continuation of the German-Austrian cooperation with the Medical Service of the Central Association of Health Insurance Funds / MDS in the area of “NUB / New Examination and Treatment Methods” (GER) and “MEL / Assessment of Individual Medical Services” (AUT). Last but not least we had to celebrate: the five-year anniversary of the Institute and the 100th edition of the HTA-Newsletter (September).

LBI-HTA Annual Reports
Contact: Smiljana Blagojevic

Horizon Scanning in Oncology: Decision Support Document No. 22 & No. 24 online (07.02.2012)

February 2012:
Erlotinib (Tarceva®) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations New!
Everolimus (Afinitor®) for the treatment of unresectable or metastatic neuroendocrine tumours of pancreatic origin New!

Horizon Scanning in Oncology: Decision Support Document No. 23 online (23.01.2012)

January 2012:
Vemurafenib for patients with BRAF V600E mutation positive advanced/metastatic melanoma New!

Reorientation of the Austrian parent-child preventive care programme. Part V: Measures to reduce preterm birth (18.01.2012)

During the first year of our project on the ´reorientation of the Austrian parent-child preventive care programme´, we identified preterm birth as highly relevant health topic. Aim of this project part V was to identify suitable primary and secondary preventive measures as well as screening methods to reduce the number of preterm births. Based on a systematic literature search we included 56 systematic reviews published since the year 2000 for qualitative analysis. For a few of the measures analysed we couldn´t find any relevant information, for almost half of the measures we found no between group differences in preterm birth outcomes. Nevertheless we identified some single interventions especially for well-defined subgroups of pregnant women, which tend to show a positive effect on preterm birth. Before implementing these “promising” measures into a parent-child preventive care program, it will be necessary to take the strengths of association between risk or protective factors with preterm birth and the prevalence of these factors in the population into account. Finally, potential “structural” causes of the, compared to other European countries, high Austrian preterm birth rate should be considered (e.g. heterogeneous definitions, influences of assisted reproductive technologies or caesarean sections).

HTA Project Report No. 050: to be available on http://eprints.hta.lbg.ac.at/939
Contact: Brigitte Piso

Centralisation of high-tech medicine: initiative / activities in Switzerland / discussion for Austria (27.12.2011)

Tuesday, 27. March 2012

15:30 - 17:30

Location:

Gesellschaft d. Ärzte

Frankgasse 8

1090 Vienna

Library

Horizon Scanning in Oncology: Decision Support Document No. 20 online (22.12.2011)

December 2011:
Abiraterone acetate (Zytiga^TM) as 2nd-line therapy for the treatment of metastatic castration-resistant prostate cancer after docetaxel therapy New!
Rituximab (Rituxan®/MabThera®) for the first- and second-line treatment of chronic lymphocytic leukaemia – 1st Update 2011

Horizon Scanning in Oncology: Decision Support Documents No. 19, No. 04/Update 2011, No. 06/Update 2011 & No. 11/Update 2011 online (05.12.2011)

December 2011:
Rituximab (Rituxan®/MabThera®) for the first- and second-line treatment of chronic lymphocytic leukaemia – 1st Update 2011 New!

November 2011:
Panitumumab (Vectibix®) as 1st-line combination therapy for the treatment of WT KRAS metastatic colorectal cancer
Gefitinib (Iressa®) for the 1st-line treatment of non-small cell lung cancer – 1st Update 2011

September 2011:
S-1 (TeysunoTM) as first-line therapy for patients with advanced non-small cell lung cancer

Job vacancy at LBI-HTA (03.11.2011)

The LBI for Health Technology Assessment works with an interdisciplinary team of scientists from the field of medicine, health economics, pharmacy, communication science and with numerous clinical and public health experts.

Currently the following position has been advertised (Dec/ Jan):

Scientific Assistant to the Director with an interest in science communication
(Vacancy - in German only)

In addition to the professional requirements, the ability of working systematically, independency, good written and spoken English skills, an interest in IT, the willingness for interdisciplinary working, international communication and the capacity for teamwork are required.

Please send your application by November 30, 2011 to the institute's director, PD Dr. Claudia Wild

Quality in oncology and its measurement (21.10.2011)

The spectrum of conditions classified under the term “cancer” poses particular challenges for quality measurement because of its complexity and multimodal treatment. To inform the ongoing development of the Austrian National Cancer Plan, this report addressed study questions around high quality oncological care and quality indicator systems to measure it. The focus is put on ongoing activities and initiatives in the area of quality measurement in cancer care. 22 of these from seven countries are presented. Further development efforts are in particular needed for quality indicators that compare subgroups, indicators for less frequent cancers, indicators that take psychosocial elements into account, address quality of life or incorporate patients’ perspectives and for end-of-life care quality indicators. Apart from the obviously required narrower know-how for indicator development and the necessary establishment of an efficient electronic data collection infrastructure, knowledge about and experience with the development of clinical guidelines and patient pathways are crucial for establishing a quality system for cancer care. In order to actually improve quality of care at the point of delivery to patients data analysis and feed-back skills are important and a sense of ownership for the quality improvement process needs to be fostered among stakeholders.

HTA Project report No. 049: http://eprints.hta.lbg.ac.at/934
Contact: Nikolaus Patera

Radiofrequency ablation for hepatocellular carcinoma and colorectal liver metastases (20.10.2011)

In Austria, the incidence of liver malignancies, such as hepatocellular carcinoma (HCC) and colorectal liver metastases (CRLM), is about 6 per 100.000 and is three times higher in men than in women. Of the various treatment options for liver malignancies, the only curative therapeutic option is liver transplantation, however, due to a lack of transplants it cannot be routinely offered. Hence, surgical resection (SRS) continues to be the gold standard in the treatment of liver malignancies but is often limited by the co-existing liver cirrhosis. Radiofrequency ablation (RFA) has recently evolved as an alternative to surgical resection. It destroys tumor tissue by applying heat delivered through electrodes (percutaneous, laparoscopic or open), resulting in coagulation necrosis and ablation of the tumor. The LBI-HTA conducted a systematic review and identified eight studies in total. Of these, five studies assessed the efficacy and safety of RFA compared to SRS for the treatment of HCC, two studies evaluated the efficacy of RFA compared to SRS for the treatment of CRLM and two studies illuminated the efficacy of single-arm RFA for the treatment of CRLM. In terms of efficacy, the available evidence indicates that SRS is superior to RFA for the treatment of both HCC and CRLM (5-year-survival, recurrence rate). However, RFA appears to be safer than SRS (overall complication rate, intervention-associated mortality) for the treatment of HCC. Due to a lack of evidence, no conclusion can be drawn about the safety of RFA for the treatment of CRLM.

Decision Support Document No. 049: http://eprints.hta.lbg.ac.at/933
Contact: Marisa Warmuth

5-year anniversary LBI-HTA (03.09.2011)

Treatment options for varicose veins (02.09.2011)

Varicose veins are the most common venous disease in German-speaking countries. Choosing an adequate therapy depends on the localisation, the size and the extent of varicose veins as well as on the presence of venous reflux. The aim of this systematic review is to evaluate the evidence concerning efficacy and safety of various treatment options for varicose veins. Therefore, we compared conservative therapy, surgery, sclerotherapy and endovenous thermal interventions, such as laser therapy and radiofrequency ablation, to one another. Additionally we tried to define a boarder between medically necessary versus cosmetically desired interventions. In total, we conducted nine comparisons of various therapeutic options with regard to pre-defined outcomes in terms of efficacy and safety. We could not draw definite conclusions for some outcomes due to the absence or lack of evidence as well as inconclusive or controversial results. Overall, the evidence indicates that minimally-invasive thermal therapies are not inferior to surgery in terms of efficacy and safety. Moreover, endovenous laser therapy and endovenous radiofrequency ablation appear to be comparable concerning efficacy and safety outcomes. However, a standardised procedure and a minimum quantity of procedures performed per surgeon need to be established. Based on this review, it is not possible to define a border between medically necessary (invasive or minimally-invasive) versus cosmetically desired (invasive or minimally-invasive) interventions.

HTA Project report No. 51: http://eprints.hta.lbg.ac.at/930
Contact: Marisa Warmuth

Outpatient cardiac rehabilitation. Part IV: Options für a prospective study (22.08.2011)

After the completion of the retrospective cohort study in June 2010 the Association of Austrian Health Insurance Providers (HVB) suggested, that the LBI-HTA should prepare options for a prospective study to assess the effectiveness of phase III cardiac rehabilitation. We discussed e.g. study aims and the organisational framework of a study in numerous meetings with representatives of HVB, pension and health insurance and AGAKAR. We did sample size calculation for all potential primary endpoints based on data from the previous retrospective study and literature. As a result we suggested a prospective, non-randomised controlled observational study with two parallel groups (with/ without phase III rehabilitation).

Decision Support Document No. 48: http://eprints.hta.lbg.ac.at/928
Contact: Brigitte Piso

Disinvestment. Overview of disinvestment experiences and challenges in selected countries (01.08.2011)

During the last decade, disinvestment has started gaining attention as a policy approach for a more efficient use of healthcare resources. Disinvestment refers to the evaluation of technologies in the last stage of their lifecycle, when they have been superseded by available alternative technologies or have been demonstrated to be ineffective/harmful. The aim of this project was to provide an overview on disinvestment activities of selected countries and to summarize challenges associated with the implementation of disinvestment policies. A systematic literature review was conducted and four countries – Australia, England, Canada and Spain - were chosen for further investigation. Concepts of identification and prioritization, as well as methods used for assessing potentially obsolete technologies and strategies for dissemination were investigated. Efforts to introduce disinvestment policies were identified in all four countries but at different levels. Lack of dedicated resources, absence of methodological frameworks and lack of comprehensive evidence for assessment purposes were identified as main challenges, together with challenges of effort duplication and potential influences from different players. Thus, as long as methods and, foremost, the impact of disinvestment strategies have not been evaluated, best practice models cannot be determined yet.

HTA Project report No. 57: http://eprints.hta.lbg.ac.at/926
Contact: Anna Nachtnebel

Horizon Scanning in Oncology: Decision Support Document No. 18 online (11.07.2011)

July 2011:
Eribulin (Halaven®) as third- or late- line mono-therapy for advanced/metastatic breast cancer

April 2011:
Second-line chemotherapy with cabazitaxel (Jevtana®) for the treatment of castration-resistant metastatic prostate cancer
Dasatinib (Sprycel®) for the 1st-line treatment of Philadelphia-chromosome positive chronic myeloid leukemia in the chronic phase

Sacral Nerve Stimulation for Fecal Incontinence (04.07.2011)

Fecal Incontinence is defined as the disability to hold the stool. The most common reason for that is an amyasthenia of the pelvic floor. There are different ways to treat this kind of incontinence. One treatment is sacral nerve stimulation, where a low voltage electrical current applies to sacral nerves via an implanted electrode to strengthen the pelvic floor muscles. For evaluating efficacy and safety of this therapy, seven relevant publications were identified. The result of the analyzed literature is that sacral nerve stimulation seems to be an effective and safe intervention to treat fecal incontinence for a selected group of patients. Belonging to the poor designs of the reviewed studies, this result is subject to considerable uncertainties.

Rapid Assessment No. 004: http://eprints.hta.lbg.ac.at/925
Contact: Ingrid Zechmeister

Reorientation of the Austrian parent-child preventive care programme (02.05.2011)

The mother-child pass examination programme was introduced in Austria for the first time in 1974. Since then, there has been a gradual increase in the number of examinations and also a steady broadening of their range. However, a systematic evaluation of the programme was never carried out, and therefore the present programme may not reflect changing needs. The primary aim of the first project year was to support decision-making processes towards a needs-based re-orientation of the Austrian parent-child preventive care programme. Based on epidemiological data, Part I of this project discussed risk factors and the frequency of diseases during the pregnancy period and early childhood years. Part II looked at the routine international screening policies of other countries and their experiences with at-risk groups within the populations of pregnant women and families with children. Part III focussed on examining the economic provisions and financial incentives as well as on costs and expenditures of the current (actual) Austrian “mother-child screenings” (provided by the Austrian “Mutter-Kind Pass” as well as by other preventative measures for pregnant women, newborns and toddlers). Against the backdrop of Parts I-III, Part IV resulted in the critical and analytical formulation of the general demand for prevention measures and screening services for pregnant women and families with children.

Contact: Brigitte Piso

Publications:
Reorientation of the Austrian parent-child preventive care programme.
Part I: Epidemiology - Frequency of risk factors and disease during pregnancy and early childhood. HTA Project Report 045a
Part II: International policies, concepts and screening strategies focusing on “normal” and “high-risk” development processes during pregnancy and early childhood until school entry. HTA Project Report 045b
Part III: Financing structures of services and public transfers for parents and young children. HTA Project Report 045c
Part IV: Synthesis of parts I-III, recommendations. HTA Project Report 045c

There is the possibility to add relevant data sources and publications that were not covered by the reports by using this form. Deadline for submission is July 31, 2011 (office@hta.lbg.ac.at). All additions are subsequently collected and will be published as Addendum on the LBI-HTA repository.

Horizon Scanning in Oncology: Decision Support Document No. 16 & 17 online (12.04.2011)

January 2011:
Ipilimumab for pre-treated patients with advanced/ metastatic melanoma
Nilotinib (Tasigna®) for the 1st-line treatment of Philadelphia chromosome positive chronic myeloid leukemia in the chronic phase

Book recommendation: (28.03.2011)

Strüngmann Forum Reports:
Better Doctors, Better Patients, Better Decisions - Envisioning Health Care 2020
Gerd Gigerenzer & J.A. Muir Gray (Ed.)

The MIT Press, April 2011

404 pages, English
ISBN-10: 0262016036
ISBN-13: 978-0262016032
Amazon

BMJ blog: Doc2Doc

LBI-HTA Annual Report 2010 (17.03.2011)

The LBI-HTA presents its fifth annual report. Besides the detailed description of the Institute in regard to its budget, institutional partners and committees, its office infrastructure and the staffing development, this report also includes an overview of LBI-HTA's completed and launched research projects in 2010. Moreover, the annual report provides key aspects of the Institute’s activities, such as publications of LBI-HTA researchers, their participation in scientific conferences, trainings, teaching and review activities as well as national and international scientific cooperation.

Highlights and challenges in 2010 included the active participation in the EU project "EUnetHTA Joint Action" (as the lead partner of work package 7B), the successful piloting of several international cooperation projects within the Horizon Scanning in Oncology program and within the annually performed MEL (single medical intervention) evaluations, the participation in the EBM congress in Salzburg (February), the publication of the Institute’s book “Zahlenspiele in der Medizin – Eine kritische Analyse” [Number games in medicine] (March), the internal research programme planning day at the Tulbingerkogel (April), the attendance of the HTAi conference in Dublin (June), the participation in the “Wien Energie Business Run“ (September), the celebration of the 50th anniversary of the Ludwig Boltzmann Society “LBG Meet Science!” (October), the Institute’s Christmas party (December), two weddings of team members and the birth of the LBI-HTA baby 2010: Valentin Eugen Ferdinand.

The annual report 2010 ends with the director’s visions and prospects for 2011, and with information regarding the development of a strategy for the Institute’s continuation beyond the year 2013.

LBI-HTA Annual Reports
Contact: Gerda Hinterreiter

Strengthening the knowledge base for a better health system. Inspirations from good practice for capacity building in health services research and public health research (21.02.2011)

To stimulate the debate on enablers of high-quality health services research and public health research, LBI-HTA initiated a project on their organization and governance. The report includes organizational examples of good practice from the Netherlands, Denmark, Norway and the UK.

Transparent processes of prioritizing research, of communicating results and of evaluating research implementation are necessary to establish a research system positively impacting the practice of political decision making. Trust between decision makers and researchers, characterized by intensive interaction along the entire research process, is a prerequisite for the user relevance of research. Scientific competence of research organizations needs to be coupled with the ability to actively communicate with decision makers and with network building skills. This can be enhanced by organizational structures in research commissioning, academia and independent research organizations. Political will, organizational leadership and sustainable funding commitments are necessary to build capacity. In addition, time is required for a culture of problem solving in mutual respect between decision makers and researchers to develop. A perspective on research that takes organizational and systemic perspectives on board, that understands the production of evidence as a shared process and that is sensitive to context offers the most promising way forward.

HTA Project report No. 48: http://eprints.hta.lbg.ac.at/908
Contact: Nikolaus Patera

Impact from HTA-research for the Austrian health care system. Part 2: Results of the empirical survey (03.02.2011)

The aim of Health Technology Assessment (HTA) is to produce independent scientific support for decision makers which should result in an improved health care system and in better population health. For legitimizing further research resources, for prioritizing future HTA research and guaranteeing its value, HTA research itself needs to undergo evaluation. On the basis of the existing framework (part 1), the empirical analysis was conducted in part 2 of the project. The impact regarding the categories awareness, acceptance, policy process, decision making, practice, final outcomes and "enlightenment" was analyzed using a combination of qualitative and quantitative methods. Due to the different methods employed, such as questionnaires, discourse analysis, economic analysis, interviews and download analysis, it was possible to detect both the impact within the different levels of the health system and the various effects arising from HTA research. The impact of HTA can be detected in all levels of the health care system. Research results are mainly used for decisions at the meso- (hospital associations) and microlevel (government) of the health care system. A multi-dimensional impact of HTA within all categories can be confirmed, which is still expandable.

Part 1: HTA Project report No. 37a: http://eprints.hta.lbg.ac.at/877
Part 2: HTA Project report No. 37b: http://eprints.hta.lbg.ac.at/907

Contact: Ingrid Zechmeister

Radiosurgery: Gamma Knife versus adapted linear accelerator (06.10.2010)

Radiosurgery (precise, high dose radiation) is used to devitalise tissue with small diameters (few mm to 3 cm). This study compares clinical efficacy (indications: brain tumours, brain metastases and 6 other indications) and cost aspects of the two application forms. The search revealed 3 HTAs with appropriate study questions resulting in indices on equality (low evidence quality), but no primary studies with a high evidence levels. Besides, indices of equality come from studies with low evidence level. Some indications (according to technical studies and expert questionnaires) seem to be treated more efficient by GK, some by aLIN indicating to use the devices according to their strength. Cost components differ (GK: higher acquisition cost but longer lifetime; radiation sources must be renewed every 7 years, but lower maintenance cost; aLIN: usable also for extracranial indications) but in combination both application forms perform with similar yearly cost. Local variables (configuration, case numbers, etc.) should therefore be evaluated for decisions on the equipment. Indications should be evaluated by means of currently available options.

HTA Project report No. 47: http://eprints.hta.lbg.ac.at/901
Contact: Stefan Mathis-Edenhofer

Kyphoplasty and vertebroplasty for the treatment of osteoporotic vertebral compression fractures - observational study (24.09.2010)

Kyphoplasty (KP) and vertebroplasty (VP) are minimal invasive procedures for the treatment of painful osteoporotic vertebral compression fractures (VCF). Aim of this observational study was to determine the longterm effectiveness of both procedures under routine care conditions. Additionally safety data (e.g. subsequent adjacent fractures, cement leakages) were collected.
Post-interventional pain reduction (KP: 67 vs. VP: 61 VAS-points) and the improvement in the Oswestry Disability Index (ODI) -Score (KP: 50 vs. VP: 37 points) were sustained with minimal losses until the end of the observation period after two years. We observed cement leakages in both groups, but none of them required further interventions. Because of between group differences in baseline characteristics (e.g. spontaneous vs. traumatic fracture, differences in ODI- Scores), direct comparison of outcomes was not feasible. We therefore conducted a descriptive analysis only. Interpretation of study results is limited because of low data quality and because the expected sample size was not reached. Nevertheless, effectiveness results of this observational study are in line with results of other non-randomised clinical trials.

HTA Project report No. 25: http://eprints.hta.lbg.ac.at/900
Contact: Brigitte Piso

Evaluation of diagnostics (09.09.2010)

For the evaluation of diagnostic technologies from a decision-makers perspective, it is crucial to assess the impact of the test on patient relevant outcomes. Even though the basic processes are comparable to those for evaluating interventions, some differences exist. This project therefore summarizes specific methodological challenges associated with the evaluation of tests and describes differences and similarities of selected institutions (MSAC, IQWiG, EUnetHTA, NICE). Based on these findings, a checklist was developed as an aid for decision-makers to structure questions on benefits, harms and costs of a test in order to facilitate the assessment of diagnostic technologies.

HTA Project report No. 36: http://eprints.hta.lbg.ac.at/898
Contact: Anna Nachtnebel

Hyperthermia (13.07.2010)

Hyperthermia is used to optimise chemotherapy or radiotherapy. A report from 2005 (ordered by the Federal Joint Committee of the German Health System) revealed no net benefit for patients. In a recent LBI-HTA report, a systematic literature search was perfomed and relevant studies selected. Those studies were critically appraised and summarised regarding to outcomes. Based on these results LBI-HTA made a recommendation.

The systematic review included 6 RCTs as well as 1 long time result. One study (rectal carcinomas) showed no advantages of hyperthermia. 2 studies (breast cancer and superficial tumours) showed no survival benefit but an effect on local control. For cervical cancer a long-term result is beneficial, but another (more recent) study failed to show any benefits. For anal cancer partial advantages are drawn in one study. All studies report more adverse events when hyperthermia is added. In none of the studies an advantage in survival or quality of life could be shown. In some studies there is an effect in surrogate measures but the clinical meaning is unclear. Side effects are more common in hyperthermia. Therefore no net benefit can be concluded from the available evidence. As a result, hyperthermia should not be used in routine care (exceptionally in clinical studies).

Decision Support Document No. 36: http://eprints.hta.lbg.ac.at/883
Contact: Stefan Mathis-Edenhofer

Screening for Colorectal Cancer. Part 1: Screening-Tests and Project Design (19.05.2010)

Colonoscopy is the final common pathway of all screening for colorectal cancer (CRC). For a screening-test in the (healthy) general population, colonoscopy is invasive and prone to serious complications. Screening-yield and rates of complications are strongly dependent on the individual operator. No data is currently available on the impact of CRC-screening on all-cause mortality. When considering first-line screening-tests on which to base an organized program, the test’s impact on participation is more important than its test-sensitivity. CT-colonoscopy, capsule endoscopy and new molecular tests are not yet viable alternatives for use in population-based mass-screening.

HTA project report No. 41a: http://eprints.hta.lbg.ac.at/873
Contact: Nikolaus Patera

Screening for Colorectal Cancer. Part 2: Health economic evaluations and developments of costs (18.05.2010)

Together with report 41a this study is a decision support document on the introduction of a colon cancer screening. The systematic review analyses available relevant evidence of systematic reviews and single studies on health economic evaluations and gives an overview on cost-offset, cost structures and mutual dependency of cost elements in colon cancer screening programs. With amounts of about €10.000,- to €20.000,- per life year gained cost-effectiveness-ratios of the considered screening strategies (colonoscopy, flexible sigmoidoscopy and fecal occult blood tests) seem to be acceptable compared to no screening. Some unrealistic assumptions about rates of adherence or sensitivity and specificity are most important limitations. Cost planning in screenings mostly are done in three phases. Depending on the screening in questions there are certain key factors described that have important impacts on development of overall costs. Based on the evidence available the implantation of a colon cancer screening for an average risk population older than 50 years seems justified under a cost-effectiveness-perspective, as long as a quality assurance is guaranteed.

HTA project report No. 41b: http://eprints.hta.lbg.ac.at/874
Contact: Philipp Radlberger

Classification of disease severity for neuro- and trauma rehabilitation Part 3: Status quo in Austria (03.05.2010)

Based on the first parts of the project “Classifying disease severity in patients with neurologic or trauma rehabilitation” (Part 1: Instruments for stroke and traumatic brain injury. HTA Project report 023a; Part 2: International experiences with quality / performance assessments and reimbursement. HTA Project report 023b) we aimed at collecting status quo data to the usage of generic and specific instruments and at identifying pilot projects in Austrian rehabilitation institutions (HTA Project report 023c). Additionally we wanted to assess opinions about the potentials and constraints of generic instruments. For data collection we developed a questionnaire and sent it to 20 Austrian rehabilitation centres via email (response rate 50%). The results show that recommendations of the Austrian Society of Neuroradiology (ÖGNR) lead to a homogenisation of used instruments. However, a standardized base documentation does not exist and there is still a variety of used measurement instruments. Pilot projects point at increasing interests in quality management and comparison between institutions.

Publications:
HTA Project report 23a (Part 1, Dez 09): http://eprints.hta.lbg.ac.at/866
HTA Project report 23b (Part 2, Dez 09): http://eprints.hta.lbg.ac.at/867
HTA Project report 23c (Part 3, May 10): http://eprints.hta.lbg.ac.at/879

Contact: Brigitte Piso

Horizon Scanning in Oncology: Decision Support Document No. 8 online (21.04.2010)

April 2010:
Plerixafor (Mozobil®) for autologous stem cell transplantation in patients with lymphoma & multiple myeloma

January 2010:
Gefitinib (Iressa®) for the first-line treatment of non-small cell lung cancer
Trabectedin (Yondelis®) for second-line recurrent platinum-sensitive ovarian cancer

October 2009:
Azacitidine (Vidaza®) for the treatment of myelodysplastic syndromes
Cetuximab (Erbitux®) in EGFR-expressing Non-Small Cell Lung Cancer
Everolimus (Afinitor®) for the treatment of advanced/metastatic kidney cancer
Rituximab (Rituxan®/MabThera®) for the first- and second-line treatment of chronic lymphocytic leukaemia
Ibritumomab tiuxetan (Zevalin®) as consolidation therapy after first remission in patients with follicular lymphoma

Contact: Anna Nachtnebel, Sabine Geiger-Gritsch

Impact of HTA-research in Austria for the health care system. Part 1: Overview - Update (19.04.2010)

Research in Health Technology Assessment (HTA) aims at supporting an adequate and efficient use of health care resources. Its objectives are providing independent information for decision makers, supporting the health care system in improving its structures, processes and outcomes as well as improving population health in Austria. For legitimizing further research resources and for prioritizing future HTA research and guaranteeing value of future research, HTA research needs itself to undergo evaluation.

On the basis of the existing literature both a definition of the term impact as well as appropriate indicators and instruments for measuring impact are presented. A systematic literature research identified 19 relevant articles to update an existing review. For further research of HTA-impact in Austria a tool kit with appropriate instruments and an evaluation design was developed. The design considers different categories of impact such as: awareness, acceptance, policy process, policy decision, practice, final outcomes and “enlightenment “. In a first step both target groups on different levels (micro-, meso-, macrolevel) and the expected impact should be identified. Qualitative and quantitative research methods which were identified in the literature will be combined to evaluate the impact from HTA empirically. This should, at the same time, guarantee validity.

Publication: HTA Project report No. 37a: http://eprints.hta.lbg.ac.at/877
Contact: Ingrid Zechmeister

LBI-HTA recent book (08.03.2010)

Zahlenspiele in der Medizin -
Eine kritische Analyse

Ed.: Claudia Wild & Brigitte Piso

ORAC, March 2010

ISBN: 978-3-7015-0523-4

Available at your nearest book store and via Amazon.de
Publisher's announcement

Haemocomplettan® P and Fibrogammin® P in acquired hypofibrinogenemia (05.02.2010)

In Austria, national transfusion guidelines do not exist, which leads to a considerable variability in the substitution of blood products among different institutions. The aim of this systematic review is, to assess the evidence concerning the efficacy and safety of two commercially available clotting factor concentrates, namely Haemocomplettan® P (fibrinogen concentrate) and Fibrogammin® P (factor XIII concentrate), which have been licensed in Austria since 1994 and 2000, respectively. These two clotting factor concentrates are mainly being used in acquired clotting factor deficiencies due to a range of underlying clinical conditions. Their consumption as well as costs have been increasing steadily for years, despite a lack of evidence proving their efficacy and safety. In addition, ROTEM® rotational thrombelastometry, a recently developed, not validated method, is being increasingly employed in estimating fibrinogen level and clot strength in order to guide the substitution of blood products. In conclusion, demanding thorough documentation of the use of Haemocomplettan® P and Fibrogammin® P, along with the development of evidence-based, national transfusion guidelines will be of utmost importance to prevent inappropriate use of blood products.

HTA Project report No. 39: http://eprints.hta.lbg.ac.at/870
Contact: Marisa Warmuth

Horizon Scanning in Oncology: Decision Support Documents No. 6-7 online (01.02.2010)

New publication series since October 2009 (English):

No.1	Azacitidine (Vidaza®) for the treatment of myelodysplastic syndromes
No 2	Cetuximab (Erbitux®) in EGFR-expressing Non-Small Cell Lung Cancer
No 3	Everolimus (Afinitor®) for the treatment of advanced/metastatic kidney cancer
No 4	Rituximab (Rituxan®/MabThera®) for the first- and second-line treatment of chronic lymphocytic leukaemia
No 5	Ibritumomab tiuxetan (Zevalin®) as consolidation therapy after first remission in patients with follicular lymphoma

January 2010:

No 6	Gefitinib (Iressa®) for the first-line treatment of non-small cell lung cancer
No 7	Trabectedin (Yondelis®) for second-line recurrent platinum-sensitive ovarian cancer

Contact: Anna Nachtnebel, Sabine Geiger-Gritsch

Acquisition Processes of Certain Product Groups in Hospitals - Orthopaedic and Cardiac Implants (11.01.2010)

Increasing cost pressure due to demographic change of society as well as new and innovative developments also affect Austrian hospitals. It is essential to utilize resources in a humane and economic efficiently way. Especially the product group implants, tends to challenge the supply management. The thesis presents a cross section of procurement of orthopaedic and cardiac implants in Austrian hospitals. Furthermore, several aspects strongly connected to the overall concept of efficient supply management are surveyed. Used methods were a literature review on procurement of implants as well as guideline-based expert interviews. The interviewed experts were key players of selected organisations who were asked about organization, product choice and procurement strategies.The results showed that procurement strategies in Austrian hospitals are changing right now. However there is no common strategy which is implemented in all of the surveyed hospitals and networks. Processes, grown over the years are only slowly being refined and so the optimization potential is not yet utilized. Already by EU-wide tendering, price reductions of about a double-digit percentage for implants seem to be achievable.

HTA Project report No. 38: http://eprints.hta.lbg.ac.at/864
Contact: Bernhard Fleischner

Status quo mammography screening: evaluation results from organised programs (15.12.2009)

Providing an overview of evaluation results from organised screening-programs, this report informs quality management of new programs and supports benchmarking efforts. In an internet search for evaluation reports of organised screening programs published in either German or English seven countries were identified: Ger, Aus, Ire, Ita, Can, NZ, UK. Evaluation results were extracted, analysed and compared.

All programs are successful in detecting small invasive cancers. Aimed for participation rates are not met by programs – except for Ireland and the United Kingdom. Program specific process results show considerable variation. Recall rates – influencing detection and false positives – vary widely. Time needed for diagnosis of screening-mammography and waiting time until recall appointment differ. Information for invited women to enable the decision against or for taking part in screening is not provided independently of program institutions (funders, service providers, management). Program evaluation is only rarely conducted independently of program institutions. Both fields require action.

HTA Project report No. 35: http://eprints.hta.lbg.ac.at/863
Contact: Nikolaus Patera

Autologous Chondrocyte Implantation (13.12.2009)

Since 1987, when (M)ACI was first mentioned, the technique has been used all over the world to treat osteochondral lesions in the knee. Nevertheless, the actual effectiveness of this relatively new treatment option is under question: clinical evidence based on controlled trials and long-term follow-up is still missing. For these reasons (M)ACI is being reimbursed in most countries only under research conditions.
The effectiveness analysis is based on 9 comparative clinical trials and 6 systematic reviews. Within the trials all together 566 patients were treated with mosaicplasty vs. ACI, microfracture vs. ACI, and ACI vs. ACI. The results show consistency and confirm earlier (international) reviews. There is no evidence that ACI or MACI leads to better outcomes in the treatment of osteochondral lesions than any of the alternative treatments. ACI is not superior; at best equal, at much higher cost. The short term (1-2 years) and mid-term (5 years) non-inferiority in highly selected active patients is proven. Long-term data are lacking.
(M)ACI methods must be considered – though often applied - as experimental techniques. The risks of cultivated chondrocyts cannot be ignored and should be given more attention.

Decision Support Document No. 34: http://eprints.hta.lbg.ac.at/865
Contact: Claudia Wild

New influenza (swine flu) data & facts for decision support (02.09.2009)

Decisions for extensive public health interventions must be made based on information without any influence by lobbies, mainly because those decisions are affecting many (also healthy) people and normally require a huge amount of public funding. The current estival swine flu scare therefore prompted the LBI-HTA to help decision makers currently working on the national pandemic plan make objective decisions, by providing key data and facts about the „new influenza“.

Concerning the classification of the World Health Organization (WHO), the dimension of the „new influenza“ spread has been set at level 6 (of 8). In contrast, the Center for Disease Control (CDC), who assesses the risk using the „Pandemic Severity Index (PSI) - which refers to lethality (the number of deaths in relation to the number of infected people) – rates the disease at level 2 (of 5). The WHO classification is a life cycle model, based on the global dispersion of the virus. According to the CDC’s calculations, the annual seasonal influenza causes up to 1 death per 1000 patients (0,10%), which equals a PSI of 1. In the United Kingdom (the country registering the most „new influenza“ cases in Europe at present) the lethality of the „new flu“ is about 0,14% (PSI 2 = 0,11-0,5%). Due to many harmless and unapparent courses of the „new influenza“, the real dimension of its expansion is at risk of being UNDERestimated and thus the actual mortality rate in danger of being OVERvalued.

Decision Support Document No. 35: http://eprints.hta.lbg.ac.at/845
Contact: Claudia Wild

Evaluations of child and adolescent psychiatry (01.09.2009)

Against the backdrop of increasing evaluation requirements relating to medical and therapeutic treatment programmes, this literature overview concerns the area of child and adolescent psychiatry. The importance of this issue derives from the fact that there is only little evaluation research concerning child and adolescent psychiatry. Furthermore, treatment programmes for mentally impaired children and young people also pursue the goal to prevent or at least mitigate mental problems in the adulthood as far as possible. Hence, evaluations in this field also contribute to the quality assurance and the sustainability of treatments for this particular target group.

Basically, this analysis deals with “global assessments“ of therapies and it does not focus on special disorders children and adolescents may suffer from. This report refers to evaluation dimensions, indicators and instruments that have been internationally documented and applied. The “therapeutic outcome”, the “treatment satisfaction” and questions on “quality of life” represent core aspects of evaluation processes. The “clinical symptomatology” is a major indicator for the identification and the scope of the principal “therapeutic outcome”. Indicators clarifying the “treatment satisfaction” and “quality of life” issues involve quality measurements describing the treatment process, the willingness to co-operate and the communication culture amongst actors (patients; parents; medical and therapeutic staff). In regards to evaluation instruments for testing the proposed indicators, numerous tools have been identified and described in detail in this report. Health economic evaluations of child and adolescent psychiatry will be discussed in a separate LBI:HTA report.

HTA Project Report No. 27: http://eprints.hta.lbg.ac.at/846
Contact: Roman Winkler

Evidence supported health services planning (31.08.2009)

Health services planning must consider aspects of demand and aspects of supply. Additionally, social aspects must be taken into account. This project report aims to identify ways of increasing scientific support and evidence based practice in the process of planning. Therefore research questions were defined, a literature search was performed and publications were selected. Finally five methods were described and steps in planning compared. Essential steps and the potential for using an evidence based approach to planning came under discussion. The comparative analysis of those five methods also highlighted ways of intensifying the use of evidence and evidence based practice. However, planning steps should be transparent. By using the core elements of planning and by acting evidence based, one can analyse one’s own planning. We recommend evidence based planning; therefore Health Technology Assessment may be applied in identifying objective need (by assessing net benefit) and might be very useful in other aspects of planning.

HTA Project Report No. 21: http://eprints.hta.lbg.ac.at/843
Contact: Stefan Mathis

Telemedicine in Stroke Management (31.08.2009)

Stroke is the third largest cause of death after cardiovascular disease and cancer in industrial countries and a major factor in permanent disability. Acute stroke care requires rapid assessment, including patients ‘medical history and accurate diagnostics: “time is brain”. The putative advantages of telemedicine are improvements in the quality of stroke care and increased use of tPA, which is associated with better health outcomes. The objective of this report is to assess the feasibility, acceptability, and treatment delivery reliability of telemedicine systems in acute stroke management. A secondary aim is to explore the feasibility and acceptability of telerehabilitation interventions in stroke management. Telestroke interventions can bring therapeutic benefits, which are currently mainly available in specialized stroke centers. Telemedicine associations were associated with an increased delivery of systemic tPA, which improved patients’ health outcomes.

Economic studies on telemedicine interventions in stroke management are lacking. Studies of higher methodological quality are needed to explore the potential cost-effectiveness of telemedicine technologies in stroke management. It is difficult to draw conclusions from the small sample of telerehabilitation studies included in this report. The few identified articles show promising results in terms of improving stroke patients’ and/or caregivers’ well-being. More research is necessary to determine the impact of telerehabilitation services. Several programs have been identified as being at the forefront of telestroke. The lack of standardized measuring and reporting of resources and health outcomes constrain comparisons between telestroke networks and the determination of best practices. More research is needed to accurately measure the clinical and economic impact of telemedicine technologies in stroke management to support policy makers in making informed decisions. Quality indicators for evaluation of telestroke projects are proposed.

HTA Project Report No. 29: http://eprints.hta.lbg.ac.at/844
Contact: Tim Johansson

Evaluation of individual medical services (MEL) 2009 (15.07.2009)

Each year, the Austrian Ministry of Health receives suggestions for numerous new medical interventions to get reimbursed. The aim is to evaluate the efficacy and safety of interventions, suggested to be included into the MEL (German for: individual medical services) catalogue. Themes (interventions) were prioritized by the Ministry of Health and contracted out to the LBI-HTA. The assessments are based on systematic reviews for each intervention and a summary of the scientific evidence according to the GRADE scheme.

For the very first time in 2009, there was a cooperation with the german NUB (German for: new diagnosis and treatment procedures) process, which also appraised with the same method for both countries relevant new medical interventions at the same time.

9 MEL Interventions 2009:

1. Chemo-nucleolysis and intradiscal electrotherapy (IDET)
These minimally invasive surgical procedures provide alternatives treatment to surgery. This review investigates the efficacy and safety of both procedures. Presently the chemonucleolysis seems to be at least as effective as other inventions but the conduction of a placebo controlled study is recommended. For the IDET the results for efficacy were more ambiguous. The occurrence of side effects in the studies included was 0% - 15%.
DSD 21a available at: http://eprints.hta.lbg.ac.at/828

Decision aid on HPV vaccination online (15.06.2009)

The LBI-HTA developed an evidence-based online information on HPV-vaccination as well as on (dis)advantages of cervical cancer screening for young girls and their parents.

To ensure the completeness while avoiding an excess of information, we chose a “multi-level design” for the online decision aid. The two main parts, “disease” and “vaccine”, consist of eight main pages each and up to 26 supplementary pages. Based on this information, individuals can make an informed judgement as to whether or not they are in favour of HPV vaccination. Our decision aid cannot and should not replace expert advice, but will hopefully encourage shared decision making.

Online available at: www.aok.de/hpv-entscheidungshilfe or www.hpv-entscheidungshilfe.de
Contact: Brigitte Piso

International comparison of antenatal care in pregnant women (08.06.2009)

Antenatal care has been offered by national programmes in Austria since the 1970s. Subsequently, the number of examinations has been increased continuously. However, medical progress requires constant adaptation of the programme.

The report aims at an international comparison of antenatal care, which is organised very heterogeneously in different countries. Type and number of examinations are only partly evidence based. One specific examination in Austria – the internal examination – is not offered elsewhere and such a programme is also not addressed in evaluations of antenatal programmes. Hence, the additional benefit from this examination is unknown.

Decision Support Document No. 33: http://eprints.hta.lbg.ac.at/826
Contact: Ingrid Zechmeister

Tocolysis in preterm labour (03.06.2009)

Premature birth before the end of the 37th week of gestation is associated with an increased risk of morbidity and mortality in newborns. The most frequent causes of early labour are infections, diseases of the uterus and the placenta, as well as fetal causes such as malformation. Using drugs to sup-press labour (tocolysis) does not prevent the causes of imminent premature birth, in most cases the birth can merely be temporarily delayed.

In Austria, the drugs used in tocolysis are the betamimetic Hexoprenalin, a low cost drug which often leads to cardiovascular side effects, and the oxyto-cin receptor blocker Atosiban, which has fewer side effects but is more costly. The aims of the systematic review were to summarise (1) existing evidence-based guidelines for the treatment of imminent premature birth, (2) existing studies on the effectiveness and safety of tocolysis and, (3) health economic evaluations of the tocolysis drugs currently authorised in Austria.

HTA Project Report No. 30: http://eprints.hta.lbg.ac.at/825
Contact: Philipp Mad

Folic acid fortification of flour in Austria - Risks and benefits (01.06.2009)

Folic acid, as a water-soluble B-vitamin, is very important for women of childbearing age because of its key-role in many metabolic processes, particularly in cell growth and cell regeneration. A folic acid deficiency in the early stages of pregnancy could lead to defects of the spinal column, so-called neural tube defects. In contrast to adolescents and adults, who normally need about 400 microgram folate equivalents a day, pregnant and breastfeeding women are in need of 600 microgram. German-speaking countries document about 1 neural tube defect per 1000 births. In the case of recurrence, the risk is about 3% and after a second occurrence about 10%. On average, between 300.000 and 400.000 children are affected by these defects world-wide. In Austria the frequency ranges from 60 to 64 cases per year. Recent studies have shown that the prevalence of neural tube defects can be reduced by the administration of folic acid before conception.

The aim of the project is to describe the recent evidence on benefits and risks, as well as efficacy and safety of potential flour enrichment with folic acid. Efficacy was analysed with regard to the decrease of neural tube defects and other birth deformities, the risk of aborts and twin births, the prevalence of cardiovascular diseases, breast cancer, colorectal carcinoma, and also the safety regarding masking of a vitamin B 12-deficiency and anti-epileptic drug therapy.

HTA Project Report No. 20: http://eprints.hta.lbg.ac.at/847
Contact: Claudia Wild

Annual Report 2008 (15.03.2009)

The Ludwig Boltzmann Institute for Health Technology Assessment presents its third annual report. Besides the presentation of the institute in regard to its budget, institutional partners and committees, its office infrastructure and staffing development, this report also contains an overview of hte LBI-HTA's completed and ongoing research projects in 2008. Moreover, the annual report includes key aspects of the institute’s activities, such as publications of LBI-HTA researchers, their participation in scientific conferences, trainings as well as national and international scientific cooperations.

Highlights and challenges in 2008 included a substantial staff expansion (from 10 to 16 persons), intensified activities in public relations matters, web presence and media coverage, the EU project “EUnetHTA" (and the preparation of its continuation in 2009+), the start of a MEL-NUB cooperation with the German “Medical Service of the Central Association of Health Insurance Funds” (MDS) and last but not least the reinforcement of already existing national collaborations with UMIT* and DUK**.
The annual report 2008 ends with the director’s visions and prospects for 2009 in respect of emphases and possible challenges, as well as the forthcoming evaluation of the institute in May.

LBI-HTA Annual Reports

* Private University for Health Sciences, Medical Informatics and Technology; Institute of Public Health, Medical Decision Making and HTA
** Danube-University Krems; Department for Evidence-based Medicine and Clinical Epidemiology

Coverage with Evidence Development - Experiences from selected countries (02.02.2009)

In order to allocate scarce resources effectively, reimbursement decisions for health technologies should be evidence-based. However, decision-makers are often confronted with the problem that study results are either not applicable to clinical routine or that high quality data is not available at all. Possible consequences of decisions under uncertainty could be high opportunity costs in terms of wasting limited resources or increased risks for patients. The concept of Coverage with Evidence Development has already been employed in the USA, England and Australia. Despite differences in the terms used, the underlying principle is identical: Reimburse-ment of technologies is tied to the condition of further evidence generation. While providing an opportunity to influence study-designs and outcomes, decision-makers should be enabled to obtain data specifically tailored to meet their needs without restricting access to promising technologies.

Results of the HTA report are: Although some differences can be found in the use of Coverage with Evidence Development in the USA, England and Australia, several common factors seem to determine the success of this decision-making tool. Suitable technologies and adequate study-designs should be identified in a clear and transparent process which includes all relevant stakeholders. If, additionally, appropriate funding mechanisms for further evidence generation are in place, Coverage with Evidence Development will prove a valuable means for reimbursement decisions.

Project Report available at: http://eprints.hta.lbg.ac.at/818/
Contact: Anna Nachtnebel

Clavicular Fractures - A systematic review of efficacy and safety of different treatment options (27.01.2009)

Clavicular fractures are common injuries and represent 10-15% of fractures in adults and 20-25% of fractures in children. They are usually regarded as non-complicated injuries. Incidence ranges from 30-60 fractures per 100.000 inhabitants and year. The goals of treatment are to restore normal anatomy, limit pain, and promote a quick return to activity or play. Different non-operative and operative treatment approaches are described in the literature and in practical use. Conservative (non-operative) management is the most common approach and includes immobilization in a figure-of-eight bandage or simple sling. Operative management includes reduction with plate fixation or different techniques of intramedullary fixation.

The objective of this HTA report is to summarise the current evidence of efficacy and safety for the various treatment options, taking into account fracture type and other variables. We searched for systematic reviews and controlled studies, published between 1998 and 2008.

The HTA report presents evidence-based algorithms that may be useful for therapy decisions in clinical routine, as well as high-quality studies that are being conducted and whose results may have an important effect on the reevaluation of the different treatment modalities in the near future.

Project Report available at http://eprints.hta.lbg.ac.at/816
Contact: Rosemarie Felder-Puig

Reimbursement processes an analysis of international practice models for maintaining the health benefit baskets of solidly financed health care systems (19.12.2008)

In view of increasing health care costs and budgetary problems, a systematic reimbursement decision process for medical technologies becomes an important instrument of allocation. Coverage decisions have a monetary impact on patients and service providers, and at the same time they implicitly decide whether a technology is implemented and more evidence can be gained. In Austria an overall catalogue of outpatient medical care has been developed on and will require a consistent process for maintenance and further development. Within this context, international practice models of reimbursement processes and their features are analysed so that critical success factors can be derived. Via hand search on websites and in databases, completed by a systematic literature search, application processes for reimbursement of medical interventions and associated literature has been identified. The criterion for including a country/process was the availability of English, German, or French templates/guidelines for external application. The templates were categorized according to the information domains of the EUnetHTA core model, the funding processes were analyzed regarding to phases and characteristics.

The following processes have been analyzed:
Australia (MSAC), Denmark (mini-HTA), Spain (GANT), Germany (G-BA, KBV innovation service), England (NICE single technology appraisal), France (HAS application form for medical procedures), Switzerland (BAG) and Austria (MEL, OÖGKK). From the 8 identified and specified country models, Germany, France and Switzerland, which are to some degree comparable to the Austrian health care system, and additionally the Austrian pharmaceutical funding process, have been analyzed according to the process phases (topic selection, assessment, appraisal, decision, implementation) and –aspects (structures, decision criteria, dealing with evidence, stakeholder involvement, communication of results, etc.).

Projekt Report available at: http://eprints.hta.lbg.ac.at/817
Contact: Elisabeth Breyer

Enzym Replacement Therapy for Lysosomal Storage Diseases (23.11.2008)

Lysosomal storage diseases (LSD) are a group of more than 40 inborn errors of metabolism. Each of them encompasses a unique spectrum and process of disease. Because of their low prevalence (cumulative prevalence of 1:8000) they belong to the group of “rare diseases”.

Therapy of LSD consisted mainly of symptom and palliative treatment until the development of enzyme replacement therapies (ERT). Due to the low number of affected patients research and development for new treatment possibilities are very complex and expensive, which significantly increases drug prices. Consequently decision makers put an effort on establishing treatment guidelines concerning when to start/discontinue the therapy and for disease and patient management. Currently there are only limited guidelines available. The main issues of treating LSD are the complexity due to the unique spectrum and process of each disease and the low prevalence, which makes it difficult to carry out all encompassing studies. As a result of approval of ERT drugs and positive results of the therapy several disease related registries (MPS I registry, HOS, Fabry registry, FOS, Gaucher registry und Pompe registry), sponsored by pharmaceutical companies were established in Europe. The idea of these registries is to facilitate and enhance communication and exchange of information between the physicians and metabolic centres.

The aim of this assessment was to give an overview of the, with ERT treatable, LSD and to summarize guidelines for diagnosis, treatment and disease management.

Decision Support Document available at http://eprints.hta.lbg.ac.at/812/
Contact: Claudia Wild

Economic aspects of clinical effective and efficient models of health services in alcohol addiction treatment - Part 1: International models and approaches of outcome measurement (22.11.2008)

In the field of addiction therapy standardised treatment strategies are often difficult to establish. The specific group of alcohol dependent patients is highly inhomogeneous in degree and character of addiction attitude. Alcohol addicts also differ in motivation, therapy adherence and social environment. It can be difficult to identify their characteristics for assign them right to groups of patients. In various ways different countries and their institutions try to handle these problems. Regional and national authorities are searching for ways to optimise strategies and programmes of treatment. Until now we cannot say to what degree such attempts are successful. Some few pharmaceutical treatments as well as psychotherapeutic treatment are widely seen as promising options. Apart from that there is a wide range of different approaches which all have in common that there is very few evidence existing about efficiency and effectiveness. From a clinical as well as from an economic perspective, establishing a consistent system of alcohol therapy is an enormous challenge.

With the method of a systematic review, literature and data analysis, structures of services in the region of Salzburg were compared with international approaches as well as real designs of alcohol therapy institutions. Research and evaluation of international evidence on organisation and cost-effectiveness of models of therapy for people addicted to alcohol.

Project Report (Part I) available at: http://eprints.hta.lbg.ac.at/813/
Contact: Philipp Radlberger

Statins: A comparison between predicted and actual effects on population health in Austria (part 2 + 3) (21.10.2008)

Since the 1990s, statins (cholesterol lowering drugs) have been increasingly used to prevent cardiovascular diseases. The Federation of Austrian Social Insurance Funds commissioned a project in which the potential health gains from statins that could be expected in Austria based on clinical studies were estimated. It was evaluated whether the expectations were met. Moreover, cost-utility ratios from statin treatment compared to non-medical lipid lowering therapy were evaluated for the Austrian health care system context.

Results are now available in the form of two reports. They complement the first report from the project (http://eprints.hta.lbg.ac.at/588/) that contains a systematic review of international economic evaluations, which was published in 2006.
Contact: Ingrid Zechmeister

Projekt Report (Part 2) available at: http://eprints.hta.lbg.ac.at/803/
Project Report (Part 3) available at: http://eprints.hta.lbg.ac.at/804/

Clinical applications of tissue engineering: An outline of the field of research, Austrian aspects and critical analysis of selected approaches (20.10.2008)

In recent years, important innovations have been made in biomedical and (molecular-) biology research by combining cell biology techniques for the selective generation of tissue. The term "Tissue Engineering" (TE) was created for these applications, which beside of basic research interests are of clinical relevance. Concerning the high costs, critics demand valid proof of the many promises made. Chosen method for the generation of thisreport is a systematic literature review with special regard to "Grey Literature". Examples for clinical TE application include chondrocyte implantation, skin substitutes, repair of bone defects and cell seeding of cardiovascular stents. Objective of the report is a summary of the state of the art of TE research with attention to clinical relevance, the documentation of Austrian research clusters and biobanks. Furthermore an evaluation of selected fields of applications regarding risks and benefits for patients is made.

Project Report available at: http://eprints.hta.lbg.ac.at/807/

Awards:

Poster Award of the Society for Basic Research (DGOC e.V.) and the German Society for Trauma Surgery, German Congress for Orthopaedics and Trauma Surgery Hannover 2008: `Tissue Engineering from Bench to Bedside – Transplantsimulation via HET-CAM Test' (Erwin Falkner as Co-Author)

Science Award- Scoliosis Research Society Worldwide Programme on `Spinal Deformity: Current Concepts´, New Dehli 2008: `Tissue Engineering & Scoliosis: Influence of Scoliotic Deformities on Cell Characteristics In Vitro' (Erwin Falkner as Co-Author)

Clinical pathways: Systematic review of outcome parameters and effectiveness (10.09.2008)

In recent years clinical pathways have been increasingly introduced in western countries as instruments for quality assurance. A survey among users of clinical pathways in 23 countries found that clinical pathways are mainly perceived as tools for improving multidisciplinary approaches to enhance quality and evidence based care. These days, clinical pathways are primarily applied in acute health care settings. Despite worldwide increased implementation of clinical pathways many questions remain on their actual impact: on the one hand there are uncertainties about their exact definition, scope and profile in contrast to other instruments of quality assurance. On the other hand, their intention, value and measurable benefit is not entirely clear. The objective of this assessment was to look closely at the potential to evaluate the impact of clinical pathways in general and to identify outcome-indicators on the basis of previous evaluations, and to give an overview of the effectiveness of clinical pathways as measured by these outcome-indicators

The appraisal orientated itself along the methodology developed by the propositions of the Cochrane Effective Practice and Organisation of Care (EPOC) Group for measuring the impact of organisational, regulative, educative and financial interventions in health.

Project Report available at: http://eprints.hta.lbg.ac.at/801

Contact: Philipp Mad

Outpatient Cardiac Rehabilitation (04.09.2008)

Cardiac rehabilitation is an essential therapeutic step in ensuring patient reintegration into work-, social- and family life following acute cardiac incidents or cardiac surgical procedures. Currently in Austria, the Phase II cardiac rehabilitation that follows the inpatient Phase I cardiac rehabilitation conducted after an acute incident, is performed mainly in inpatient rehabilitation centers. A small portion of cardiac patients in Austria participate in outpatient rehabilitation programs; internationally the routine form of care of Phase II cardiac rehabilitation is outpatient. The objective of the first part of this report, on the one hand, is to identify indicators which are suitable for the formative and summative evaluation of outpatient cardiac rehabilitation, and on the other hand, to analyze appropriate methods or instruments to measure the processes and results.

The objective of the second part of the report is the comparative analysis of various rehabilitation models of Phase II as well as an analysis of the efficacy of Phase III interventions.

Project Report available at: http://eprints.hta.lbg.ac.at/800/

Horizon Scanning in Oncology Concept Development for the Preparation of a Horizon Scanning System in Austria (03.09.2008)

The development of new therapy modalities in oncology, the so-called "targeted therapies” such as e.g. monoclonal antibodies, has resulted in swift increases in medicine costs in hospitals. The fast and, to some extent, uncontrolled implementation of these expensive cancer medicines has affected Austrian hospital drug budgets.

The development of a Horizon Scanning System (HSS) which aims at identifying and evaluating new drug therapies in oncology early on, i.e. before their routine introduction for cancer treatment, could prepare Austrian hospitals (hospital administrators and drug commissions respectively) for new anticancer medicines, and could contribute to making rational decisions and planning prospective budgets. The main components of such a Horizon Scanning System are the determination of relevant information sources for the systematic identification of emerging anticancer drugs, the establishment of a useful filtering and prioritisation instrument, the set up of a network of Austrian oncologists involved in the Horizon Scanning process and the definition of the parameters and the format of early assessment.

This project was performed in order to develop a concept for the preparation of a HSS for anticancer drugs in Austria and to test the two important steps of identification and priority setting within a first feasibility study.

Project Report available at: http://eprints.hta.lbg.ac.at/798/

HTA-report on non-specific back pain (03.08.2008)

Back pain, and particularly non-specific low back pain, is a common reason for physician visits in all Western industrialized countries. A large list of treatment approaches is available. Patients receiving these treatments and managed by health care providers from different specialities appear to have similar outcomes, although the cost of care often differs substantially both between and within specialities. The availability of evidence-based data and guidelines has greatly improved the knowledge of what does and does not work for back pain, and there is widespread agreement and some evidence that adherence to evidence-based practice can help improve back pain patient outcomes and reduce arbitrary variations in care. Despite these advances, the best available evidence often does not inform everyday clinical decisions. A new HTA-report discusses this problem and summarizes possible strategies of how to improve the care for patients and overcome structural barriers in Austria.

Project Report available at: http://eprints.hta.lbg.ac.at/794/

Published: "Clinical and health economic registries in the field of cardiovascular, spinal and neurologic diseases. Application and Good Practice Strategies. HTA project report" (30.07.2008)

The report describes the current use of registries and how register projects can be characterised. Furthermore it presents strategies for successfully establishing and maintaining registry projects. Chapters 4 and 5 present basic principles and further literature about registries, chapter 6 introduces a scheme for characterising registries and chapter 8 contains a collection of Good Practice Strategies for working with registries. The evidence for the report stems from two systematic literature reviews as well as structured interviews with experts.
The report is available online in german only.

Job vacancy at the LBI-HTA (22.05.2008)

information only available in German language

Rapid assessment: Rational vaccination policies (06.02.2008)

Accompanying the LBI-HTA HPV-assessment an additional document to support vaccination decisions in the future was carried out. Its intention is to support health policy by providing a standardized basis for rational decision making on vaccine introduction. A most comprehensive framework is described and a stepwise procedure is suggested. Comments, examples and caveats are given for each step and therefore provide a basis for further discussions. The document is supposed to enforce international discussion.

Project report: Economic evaluation of HPV vaccination in Austria (29.01.2008)

Various epidemiological observations have shown a correlation between infections with certain human papilloma viruses and the development of cervical carcinoma, respectable carcinoma in its early stages. Recently, though only secondary to the successful screening programmes for early detection (pap smear tests), immunization against some high-risk HPV types became possible. Based on a health economic model long term effects and costs of vaccination compared to current screening have been analysed for the Austrian population. The results are now available.

HTA course of the LBI-HTA (09.01.2008)

The LBI-HTA will be holding a HTA course at the Danube-University in Krems. The course will include an introduction to HTA and health policy, an introduction to its methodology and the presentation of practical examples. The HTA course will be held from May 5th to May 10th 2008, and due to high demand, from November 3rd to November 11th 2008. The second course is for students of the university's Health Services Research (MBA) course, while the first is open to external participants. Both courses are already fully booked.

Job vacancy at the LBI-HTA (03.01.2008)

To enlarge our team of researchers with different scientific background and an information specialist we look for a medical doctor. Candidates with profound knowledge in epidemiology and EBM and are invited to apply for the job.

Rapid assessment: Avastin® (22.10.2007)

The incidence of neovascular age-related macular degeneration (AMD) rapidly increases with age. The FDA and EMEA have approved the monoclonal antibodies Pegaptanib (Macugen®) and Ranibizumab (Lucentis®) for intravitreal therapy. A third drug, Bevacizumab (Avastin®), has not been approved for this indication, however, because it is 30 times less expensive than Lucentis it is used „off-label" much more in clinical settings than the approved drug Lucentis®. Chemically, Ranibizumab, is a fragment of the Bevacizumab protein; both substances have been developed by Genentech laboratories and show similar pharmacodynamics. Due to demographic changes, AMD is becoming an increasingly important cost factor. Health care policy-makers face the challenge of making sure that the resources available for AMD-patients are used in the most efficient way possible. The aim of this Rapid Assessment LBI-HTA is to clarify the safety risks for AMD-patients treated with Avastin® and to estimate the liability risks for the providing physicians and institutions.

New projects at the LBI-HTA (30.08.2007)

Within the last weeks 9 new research projects have started at the LBI-HTA. Each of the projects will be worked on for between four months and one year. The topics for the projects were decided by means of a two-step topic-finding and priority setting process during a board meeting in April 2007, at which institutional partners, the institute's director and the researchers were present. Subsequently, structured "protocols" were developed by the relevant researchers. These included details of project designs, aims of the projects, methodology, time planning, and the possible inclusion of external experts.

Project report: Evaluation of quality assured, mammography-based breast cancer screening programmes (21.08.2007)

In Austria several pilot projects about mammography-based breast cancer screening are currently being initiated and implemented to different degrees. In light of this, it seems appropriate to look in more detail at the evaluation of such quality assured screenings. This report has been requested by the regional government of Salzburg, and summarises the current situation of mammography screening in Austria, before describing in detail international evidence about methods of evaluation of existing mammography-screening programmes. In the context of each of the programmes, fields of activities are defined and outlined using different quality indicators and the degrees of attainment of defined target values. The next part deals with different ways of systematising programmes and constructing frameworks, and the evaluation of mammography-screenings is analysed from a broad HTA-perspective. The report is intended to be an evidence-based aid to programme evaluation. It should also help quality assurance and evaluation of Austrian mammography screening programmes to be implemented on the basis of international evidence-based high quality criteria from the outset.

Job vacancy (08.08.2007)

The Review Centre for Evidence-based Medicine in Graz looks for a medical doctor. Candidates with training in EBM and biometrics are invited to apply for the job. For further details please read this text.

Project report: Testing for HER2 Positive Breast Cancer (08.08.2007)

With regard to the availability of a targeted monoclonal antibody therapy for HER2 positive breast cancer, a report about the accurate detection of HER2 status was implemented by the LBI-HTA. The identification of patients that benefit from trastuzumab should be prioritized for clinical and cost reasons. The main focus was directed at the two also in Austria most commonly used methods, IHC and FISH. Increased efforts in accurate testing with rarely false-positive or false-negative outcomes will positively influence effects and costs for therapy. Based on the results from recent studies, there seem to be less HER2 positive women than generally reported. Because of variations in tests, inter-observer and inter-laboratory variabilities, recommendations concern primarily the use of standardized and approved tests, improvement of logistics, preference of more experienced centres, external evaluation and national and international exchange of experiences.

Anniversary celebration of the LBI-HTA (24.05.2007)

On May 22th 2007 the one year old existence of the LBI-HTA was celebrated in the presence of partners and friends. The team thanked the director of the institute, Dr. Claudia Wild, with cinematic impressions of the institute´s life. Then the editor in chief of the ÖKZ, Mag. Andrea Fried, appreciated the work of the last year and wished a long life for the LBI-HTA. Supported by the trio TJO it became an evening in a cheerful mood.

First meeting with the scientific council (22.05.2007)

On May 4th 2007 the LBI-HTA had a visit from the the scientific council that consists of Univ. Prof. Dr. Norman Waugh (University of Aberdeen's Department of Public Health), Univ. Prof. Dr. Alistair Gray (Health Economics Centre at the University of Oxford), Univ. Prof. Dr. Finn Borlum Kristensen (Danish Centre for Evaluation and Health Technology Assessment), Univ. Prof. Dr. Jürgen Windeler (Medizinischer Dienst der Spitzenverbände der Krankenkassen) and Dr. Dagmar Lühmann (Institute for Public Health at the University of Lübeck). First Prof. Kristensen was elected chairman. Then the members of the scientific council met the staff of the LBI-HTA. Various possibilities of cooperating and transferring know-how were discussed. That way the scientific council carries out a supporting role that should contribute to the further success of the LBI-HTA.

Project report: Role and positioning of university outpatient departments (17.04.2007)

Under increased budgetary and capacity constraints, out-patient services as well as in-patient care provision in university hospitals have to concentrate on specialized services not covered elsewhere. An assessment aimed at answering the question "How can the services of outpatient clinics of university hospitals be defined in contrast to health care services offered by specialised physicians and/or outpatient clinics in peripheral hospitals?" A systematic literature review complemented by a survey of the management of university hospitals, summarizes the state of the discussion. A methodology to empirically analyse the data on the performed services was developed as a prototype and probed. A matrix for systematically categorising the performed services according to their ‘depth of care' was developed.

Internal manual of the LBI-HTA (31.03.2007)

In order to make our methods and processes transparent, we, the LBI-HTA, worked out a methods manual. The first part (External manual) was published in January, the second part is available to the public from now on. This internal manual is intended to make the routes to the results reproducible. The standardisation of processes and of terminology, and of supporting research with toolkits such as templates for the external and internal validity of studies, evidence tables, classification schemes etc. is aim of this part of the methods manual.

Project report: Neonatal care of low-risk newborns (29.03.2007)

The health outcome of newborns is not only influenced by obstetric care but also by neonatal care immediately after birth. A recently published assessment addresses the relation between different neonatal care strategies (24h on site paediatrician or visiting consultants with on call duties) and outcome of newborns to inform health care planning in Styria. Via conventional database searches no studies for answering the question could be identified. Hence, Styrian health care data, international guidelines and information concerning current standards of neonatal care were used for informing evidence based care planning. High quality care for newborns primarily requires quick and adequate action in the case of adaptation problems by highly experienced medical personnel. Hence, the question was primarily discussed in context with centralisation and regionalisation.

Rapid assessment: Drug eluting stents (26.02.2007)

On the occasion of the debate on the long-term safety of drug-eluting stents (DES) the Ludwig Boltzmann Institute of Health Technology Assessment carried out a rapid assessment: in the course of the year 2006 several studies on the safety of DES were presented and discussed at different congresses for cardiologists. The controversial debates led to uncertainties and a reduced use of DES in several countries, esp. Sweden where data from a registry enforced the observations of increased rates of late stent thrombosis. Already earlier assessments presented no difference in mortality between DES and bare metal stents (BMS), more recent analysis showed increased rates of stent-thrombosis esp. in patient with complex conditions and after discontinuation of co-medication.

Annual report 2006 (16.01.2007)

The Ludwig Boltzmann Institute of Health Technology Assessment was founded in April 2006: the
first annual report can be downloaded. The challenge of the first half year of the institute´s existence was - next to setting up the institute, to organizing the infrastructure and to recruiting the staff - to start and accomplish already the full research programme. This was not an easy task, since naturally organisational and communicational procedures and with it the institute´s culture had to be shaped and set up from the scratch as well.

Vienna Science and Technology Fund: Project ideas can be submitted (15.01.2007)

The Vienna Science and Technology Fund (WWTF) is currently exploring the possibility of a call for innovative clinical research 2007 within its Life Sciences programme. The programme wants to support independent, non-commercial basic research projects that have a clear goal for clinical application. In this 1st stage the WWTF asks for an Expression of Interest till February 20th. The actual call will take place in spring 2007.

Methods manual (05.01.2007)

In this "external" manual (part 1) the conceptions and processes of the LBI-HTA are portrayed, in order to present - in a transparent manner - our scientific basis. Part 2 ("internal") of the manual will be published in february and will deal with methodology, to illustrate - following international standards - the pathways to the results and to make them traceable.

Effectiveness of intensified physician-patient communication (07.12.2006)

The research project that dealt with the effectiveness of intensified physician-patient communication was finished in October 2006. The outcome parameters were attainment of therapeutic goals, patients´ compliance, patients´ participation, patients´ self-management and satisfaction as well as a reduction of additional health care costs. Further details can be taken from the project report.

Horizon Scanning System (27.11.2006)

Within the project "EU newsletter on emerging technologies" the first results are yielded. The project report Horizon Scanning System (HSS). An Overview is available from now on. The function of horizon scanning systems is to support policy makers with timely information on new health technologies so that their adoption and diffusion can be controlled. The available report sheds light on the basic processes of horizon scanning as well as the differences between horizon scanning systems that already exist.

Official opening ceremony (31.10.2006)

In the presence of about 140 invited guests the LBI-HTA was inaugurated by Dr. Ferdinand Maier, vice-president of the Ludwig Boltzmann Society, on October 13th. Prof. Dr. Peter Sawicki, director of the IQWiG, took the audience along in his official speech on a travel through time that illustrated how difficult it is to accept research results which do not follow the current trends in science. Then the director of the LBI-HTA, Dr. Claudia Wild, presented the newly founded institute. The musical programme of the evening came from the Trio Kohelet that started with an ironic comment by performing the song “Wir leben ewig”, i. e. “We live eternally”.

Job vacancy at the LBI-HTA (17.10.2006)

To enlarge our team of researchers with different scientific background (Psychology, Health Economics, Medicine, Communication Science) and an information specialist we look for a medical doctor. Candidates with training in EBM and experience in Health Service Research are invited to apply for the job.

LBI Health Technology Assessment

Horizon Scanning in Oncology: Decision Support Document No. 36 online (13.06.2013)

Horizon Scanning in Oncology: Decision Support Document No. 37 online (10.06.2013)

Re-orientation of the Austrian parent-child preventive care programme. Part IX: Recommendations from evidence-based guidelines for screening measures during pregnancy and early childhood (0-6 yrs.) (14.05.2013)

Hybrid operating room (18.04.2013)

Horizon Scanning in Oncology: Decision Support Document No. 35 online (21.03.2013)

Marketing Authorisations under Exceptional Circumstances for Oncology Drugs (20.02.2013)

Screening for Colorectal Cancer. Part 3: Status screening-activities and quality assurance of screening-colonoscopy (18.02.2013)

Job vacancy at the LBI-HTA (25.01.2013)

Avastin for Age-related Macular-Degeneration. Evidence synthesis after CATT, IVAN, MANTA (22.01.2013)

Health status and access to health care of homeless people: A literature review (14.01.2013)

Horizon Scanning in Oncology: Decision Support Document No. 34 online (11.01.2013)

Efficacy of Hyperthermia treatment in combination with radio- or chemotherapy in Breast-, Bladder-, Cervix carcinoma and Soft tissue sarcoma patients (10.01.2013)

Day Surgery (10.01.2013)

Therapeutic hypothermia (TH) (23.11.2012)

Horizon Scanning in Oncology: Decision Support Document No. 33 online (08.11.2012)

Screening for Colorectal Cancer (31.10.2012)

Universal HIV-Testing. International Recommendations and actual risk of HIV-Infections for Healthcare-Workers (05.10.2012)

Horizon Scanning in Oncology: Decision Support Document No. 31 online (26.09.2012)

Horizon Scanning in Oncology: Decision Support Document No. 32 online (24.09.2012)

Horizon Scanning in Oncology: Decision Support Document No. 29 online (12.09.2012)

Occupational therapy Part I  Status quo in Austria and Part II: Occupational therapy for rheumatoid arthritis (11.09.2012)

Occupational Therapy Part III. Occupational therapy for patients after stroke (11.09.2012)

Occupational Therapy Part IV for Dementia and Part V for Depression (11.09.2012)

Outpatient cardiac rehabilitation. Part V: Study protocol  Multi-centre, prospective cohort study with two control groups (with/ without phase III) (10.09.2012)

Extracorporeal shock wave therapy (ESWT) in non-union or delayed union of fractures (09.09.2012)

Horizon Scanning in Oncology: Decision Support Document No. 30 online (31.07.2012)

Evaluation of individual medical services 2012 (27.07.2012)

Horizon Scanning in Oncology  Impact- und Umfeldanalyse (27.07.2012)

Re-orientation of the Austrian parent-child preventive care programme: Update Part I and IV (incl. Addendum) (26.07.2012)

Horizon Scanning in Oncology: Decision Support Documents No. 25, 26 & 28 online (13.06.2012)

Quality Appraisal of Written Consumer Health Information for Patients with Chronic Myeloid Leukaemia (CML) (25.05.2012)

Horizon Scanning in Oncology: Decision Support Document No. 27 online (24.05.2012)

Re-orientation of the Austrian parent-child preventive care programme, Part VI: Health visiting services in the context of health care programmes for pregnant women, parents and children (22.05.2012)

Re-orientation of the Austrian parent-child preventive care programme, Part VII: Potential of an electronic implementation (22.05.2012)

Re-orientation of the Austrian parent-child preventive care programme. Part VIII: Review of economic evaluations and budget impact analysis of measures to reduce premature birth and outreach services (22.05.2012)

Generic indicators for process quality in oncological care: A compendium (24.02.2012)

Horizon Scanning in Oncology: Decision Support Document No. 21 online (17.02.2012)

LBI-HTA Annual Report 2011 (13.02.2012)

Horizon Scanning in Oncology: Decision Support Document No. 22 & No. 24 online (07.02.2012)

Horizon Scanning in Oncology: Decision Support Document No. 23 online (23.01.2012)

Reorientation of the Austrian parent-child preventive care programme. Part V: Measures to reduce preterm birth (18.01.2012)

Centralisation of high-tech medicine: initiative / activities in Switzerland / discussion for Austria (27.12.2011)

Horizon Scanning in Oncology: Decision Support Document No. 20 online (22.12.2011)

Horizon Scanning in Oncology: Decision Support Documents No. 19, No. 04/Update 2011, No. 06/Update 2011 & No. 11/Update 2011 online (05.12.2011)

Job vacancy at LBI-HTA (03.11.2011)

Quality in oncology and its measurement (21.10.2011)

Radiofrequency ablation for hepatocellular carcinoma and colorectal liver metastases (20.10.2011)

5-year anniversary LBI-HTA (03.09.2011)

Treatment options for varicose veins (02.09.2011)

Outpatient cardiac rehabilitation. Part IV: Options für a prospective study (22.08.2011)

Disinvestment. Overview of disinvestment experiences and challenges in selected countries (01.08.2011)

Horizon Scanning in Oncology: Decision Support Document No. 18 online (11.07.2011)

Sacral Nerve Stimulation for Fecal Incontinence (04.07.2011)

Reorientation of the Austrian parent-child preventive care programme (02.05.2011)

Horizon Scanning in Oncology: Decision Support Document No. 16 & 17 online (12.04.2011)

Book recommendation: (28.03.2011)

LBI-HTA Annual Report 2010 (17.03.2011)

Strengthening the knowledge base for a better health system. Inspirations from good practice for capacity building in health services research and public health research (21.02.2011)

Impact from HTA-research for the Austrian health care system. Part 2: Results of the empirical survey (03.02.2011)

Radiosurgery: Gamma Knife versus adapted linear accelerator (06.10.2010)

Kyphoplasty and vertebroplasty for the treatment of osteoporotic vertebral compression fractures - observational study (24.09.2010)

Evaluation of diagnostics (09.09.2010)

Hyperthermia (13.07.2010)

Screening for Colorectal Cancer. Part 1: Screening-Tests and Project Design (19.05.2010)

Screening for Colorectal Cancer. Part 2: Health economic evaluations and developments of costs (18.05.2010)

Classification of disease severity for neuro- and trauma rehabilitation Part 3: Status quo in Austria (03.05.2010)

Horizon Scanning in Oncology: Decision Support Document No. 8 online (21.04.2010)

Impact of HTA-research in Austria for the health care system. Part 1: Overview - Update (19.04.2010)

LBI-HTA recent book (08.03.2010)

Haemocomplettan® P and Fibrogammin® P in acquired hypofibrinogenemia (05.02.2010)

Horizon Scanning in Oncology: Decision Support Documents No. 6-7 online (01.02.2010)

Acquisition Processes of Certain Product Groups in Hospitals - Orthopaedic and Cardiac Implants (11.01.2010)

Status quo mammography screening: evaluation results from organised programs (15.12.2009)

Autologous Chondrocyte Implantation (13.12.2009)

New influenza (swine flu)  data & facts for decision support (02.09.2009)

Evaluations of child and adolescent psychiatry (01.09.2009)

Evidence supported health services planning (31.08.2009)

Telemedicine in Stroke Management (31.08.2009)

Evaluation of individual medical services (MEL) 2009 (15.07.2009)

Occupational therapy Part I Status quo in Austria and Part II: Occupational therapy for rheumatoid arthritis (11.09.2012)

Outpatient cardiac rehabilitation. Part V: Study protocol Multi-centre, prospective cohort study with two control groups (with/ without phase III) (10.09.2012)

Horizon Scanning in Oncology Impact- und Umfeldanalyse (27.07.2012)

New influenza (swine flu) data & facts for decision support (02.09.2009)

Reimbursement processes an analysis of international practice models for maintaining the health benefit baskets of solidly financed health care systems (19.12.2008)

Horizon Scanning in Oncology Concept Development for the Preparation of a Horizon Scanning System in Austria (03.09.2008)