Scientific Report 2013
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Scientific Report 2013 Ente Ospedaliero Cantonale Index Preface 5 4. Swiss Clinical Trial Organization 87 4.1 EOC Clinical Trial Unit (CTU-EOC) 88 1. Oncology Institute of Southern Switzerland (IOSI) 9 1.1 Medical Oncology Service 12 5. Scientific Research Advisory Board (ABREOC) 91 1.2 Radiation Oncology Service 13 1.3 Medical Physics Unit of the Radiation Oncology Service 15 6. The new Federal Act on research involving humans (HRA) and General 95 1.4 Nuclear Medicine Service and PET/CT Centre 16 Authorization for research studies granted to the EOC by the Berne 1.5 Palliative Care Service 18 Panel of Experts on Professional Confidentiality in Medical Research 1.6 Haematology Service 20 1.7 Research Division 22 7. Publications in 2013 99 1.8 IOSI Nursing Service 30 Publications in peer-reviewed journals in 2013 101 Publications in non-peer-reviewed journals in 2013 124 2. Neurocenter of Southern Switzerland (NSI) 33 Publications of medical congress abstracts in 2013 124 2.1 Multiple Sclerosis Centre 34 Publications in books in 2013 140 2.2 Sleep and Epilepsy group 37 2.3 Movement Disorders 41 8. Appendices 143 2.4 Stroke Center 43 Appendix 1 - Research projects funded by ABREOC in 2008 144 2.5 Neuropsychology 44 Appendix 2 - Research projects funded by ABREOC in 2009 146 2.6 Neurosurgery 45 Appendix 3 - Research projects funded by ABREOC in 2010 148 2.7 Neuroradiology 46 Appendix 4 - Research projects funded by ABREOC in 2011 150 2.8 Neuroanaesthesia 47 Appendix 5 - Research projects funded by ABREOC in 2012 - 2013 152 2.9 Experimental laboratory 49 Appendix 6 - EOC Projects 2013 subject to General Authorisation (AG) 152 3. EOC Multisite Departments and Services 55 3.1 EOC Department of Surgery 56 3.2 EOC Department of Internal Medicine 61 3.3 EOC Department of Intensive Care Medicine 69 3.4 Paediatric Department of Southern Switzerland 72 3.5 EOC Department of Laboratory Medicine 78 3.6 Anaesthesiology Services 78 3.7 Geriatric Service 79 3.8 Gynaecology and Obstetrics Services 80 3.9 Radiology Services 81 Together for a better care Preface Preface Let me start by referring to an unequivocal figure: the two features which are essential to ensure In particular, the Act contains provisions relating Medical Research on 7th May 2012, will remain + 26% in only one year. I am talking about the safe and quality treatments. This positive develop- to the use of biological material and personal data valid until the expiration date of May 2017. increasing number of EOC's peer-reviewed scien- ment in the gradual growth of scientific research of patients for research purposes. tific publications in just 12 months (2012: 194 produced within the EOC is - along with the One of these provisions specifically authorizes Finally, I wish to express my gratitude to all those vs. 2013: 244 peer-reviewed publications), many increasing consolidation of the Clinical Trial Unit their use, as stated in Article 321bis of the who - once more and with great dedication, com- of which are the result of multicenter studies and basic and translational research - the best Criminal Code, in case it is not possible to obtain mitment and passion - contributed to a further mainly based in Ticino Canton, with both national basis and one of the fundamental pillars within the consent of the patients or it is not feasible to growth of knowledge produced by scientific re- and international important collaborations. As a the newly-established Human Medicine Master of provide them with the necessary information on search in the clinical field in order to put it quickly result, the number of journals with good impact the future Department of Biomedical Sciences, the right of opposition. at the disposal of our patients who resort to our factor, where these studies were published, also Università della Svizzera Italiana. services. increased. In addition, if we include the publica- The Act invests the cantonal ethics committees tion of 12 books or chapters in books, 12 original The Federal Act on research involving humans with powers to grant permission for research. Until quite recently, we have taken particular care articles published in non-peer-reviewed scientific (HRA), approved by the Federal Parlament on Therefore, the Federal Commission of Experts on to add "time to life", while nowadays - as we are journals and 175 communications at national and 30th September 2011, and its associated Professional Confidentiality in Medical Research able to offer effective, quality and safe treatments international conferences, we can immediately ordinances, and namely: the Ordinance on human of Bern, terminated the task with the entry into - it becomes increasingly important to ensure that appreciate the dynamism with which everyone is research (HRO), the Ordinance on clinical trials force of the Human Research Act. Regarding the these treatments can really add "life to time". We working in the scientific research field within our in human research (ClinO) and the Ordinance on authorizations issued by 31st December 2013, sincerely hope that research development will be institutes and therefore, the EOC's services. Such organizational aspects of the Human Research the transitional provision of the Act states that all effectively oriented towards meeting the require- a growing development of scientific research is Act (OrgO-HRA), entered into force on 1st Janu- (special and general) authorizations to disclose ments and practical needs of our patients. the best basis to ensure our patients to receive ary 2014. These new regulatory provisions sub- professional secrecy for clinical research studies increasingly updated and timely treatments, stantially represent the development, as legally will remain valid until they expire. Therefore, the thanks to the prompt transfer of the most recent required, of instruments which are necessary general authorization to disclose professional Fabrizio Barazzoni MD MPH knowledge from this sector to patients. Further- to carry out scientific research in our Country in secrecy for research studies carried out at the FMH Prevention and Public Health Head of the Medical Area of the EOC Head Office more, if we add our inter-and multidisciplinary order to meet challenges that increasingly arise EOC's institutes and granted by the Bern Commis- Chairman of the Scientific Research Advisory Board Bellinzona, July 2014 approach to patient care, then we are faced with in this area. sion of Experts on Professional Confidentiality in 6 Scientific Report 2013 Preface 7 1 Oncology Institute of Southern Switzerland (IOSI) 1. Oncology Institute of Southern Switzerland (IOSI) Introduction in Biomedicine (IRB) are part of the Institute of On- of malignant lymphomas, the current database Giovanni) – or through studies carried out within The IOSI includes all the specializations dealing with cology Research (IOR) and are run by the "Fondazi- includes more than 2,300 patients treated since the IOSI, as in the case of the International Breast oncology within the EOC in a single organizational one ticinese per la ricerca e la cura dei linfomi" (Ti- 1980, for whom all the diseased tissue has been Cancer Study Group. The IOSI has always been one structure. The IOSI has been devised on the basis cino Foundation for the research and treatment of re-examined by the same team of pathologists. of the most active centres in Switzerland for the of the North American model of "comprehensive lymphomas), although functionally, they are part of Moreover, we are merging our lymphoma da- assessment of new oncological drugs. cancer centres", but has its own particular struc- the IOSI’s research division. tabase with the one of the University of Novara, This requires laboratory research (pharmacog- ture, as it has a horizontal structure throughout which has been built up based on our template. enomics, pharmacokinetics and pharmacodynam- the EOC. Research These databases are essential for the develop- ics) and structures for clinical coordination which Research is a strategic sector for the IOSI, which ment of new research ideas and also for a quality can, where necessary, carry out Phase I and II tri- The IOSI is, therefore, intended to be an all-inclusive allocates more than 15% of its annual budget to control of the results achieved. als independently. The Trial Unit Sponsor of the structure, containing all the specializations that this sector. IOSI has been integrated into the CTU-EOC. deal with the diagnosis, treatment and research in From the very beginning the IOSI has focused on Another specific feature of the research carried At a national level most of the clinical studies are the field of tumour diseases. three main areas of research: out by the IOSI is constantly to try to link clinical carried out within the structures of the Swiss • malignant lymphomas, studies to laboratory research, which is carried Group for Clinical Cancer Research (Schweizer- The IOSI has six Services: medical oncology, radi- • new drugs, out in the structures of the IOR. In the field of clini- ische Arbeitsgruppe für klinische Krebsforschung, ooncology, haematology, nuclear medicine, pallia- • breast cancer. cal research, the ties with international research SAKK). tive care and research. Each service has its own In the last years another important area of re- groups are of particular importance, either directly research program coordinated by the IOSI’s Sci- search, developed by the division of nuclear medi- managed by the IOSI – as in the case of lympho- The IOSI has spent around 7 million Swiss francs entific Board, which meets once every two months cine, is represented by thyroid cancer. mas with the International Extranodal Lymphoma on research during 2013. Two thirds of this sum and decides on common research guidelines. The For every research topic, the IOSI has a database Study Group (IELSG) whose "operational office" is has been spent on laboratory research while one research laboratories of the Institute for Research containing the records of all patients.