EDITORIAL 1 . CAHTA PROJECTS 2

New Evidence-Based Clinical Practice Guidelines 2 Perception of

school bullying in children and adolescents 2 Shared Clinical Record in Catalonia 3 Amotosalen for

. RESEARCH 5 Minority diseases, the target of . TODAY THE DISCUSSION IS… 6 . INTERVIEW Carlos Sisternas, from Fenin 8

inactivation of pathogens 4 Ischemic cardiopathy 4 the 2009 TV3 Telethon 5

Diagnostic imaging techniques: benefits and uncertainties It has been a long time since we have addressed the issue of technologies, those technologies understood to be “geniuses” at the service of disease diagnosis and treatment. And now, the time has come to address this issue again, since important changes have taken place in some fields. We believe that diagnostic imaging techniques should be highlighted, as they are in part the reason why the CAHTA was created. The use of new engineering solutions and reduced space and energy requirements, among others, have made this sector boom again, giving rise to fascinating solutions such as the construction of 3D images, 4D ultrasound, or PET/CT. Nevertheless, some points still remain to be further discussed and examined. Firstly, we believe that the assessment of these advances is not sufficiently adequate. Diagnostic sensitivity, negative predictive value and specificity have all been improved upon dramatically; however, assessments should be carried out simultaneously in order to decide whether all these improvements in the diagnostic field have also translated into therapeutic improvements or into new protocols. Secondly, no analysis has been made on the capacity of these technologies to improve productivity. That is, we know that they are better for diagnosis, but we do not know whether in addition to that they allow us to work better and with enhanced performance and accessibility. One thing is certain, and that is the higher cost of these technologies. Hence, a thorough review of their cost-effectiveness

profile is needed (as well as utility, if that is the case) and depending on the results a new planning might then be called for. And last but not least, radiation exposure and its noxious effects should be openly discussed. This is a concept that often goes unnoticed, except for the professionals directly involved, and which is not taken into account that often. Digital processing of images clearly improves the profile of radiation exposure and the combination of technologies (for instance, PET+CT) allows for improved efficiency in this regard. The duplication of tests may become unnecessary when patient image repositories are available but one must also think about decision-making help tools such as the ones we have recently developed here at the CAHTA for the diagnosis of lumbalgia following the model from the American College of Radiology (ACR). Not only that, but we should also think about setting up the radiological card (not necessarily in a physical format, but rather designed for use within the context of the shared clinical record) which would enable the clinician to assess and validate each radiological test before it is performed. In conclusion, we welcome such technological progress and improved diagnostic capacity but we must keep in mind that such advances should be accompanied by improved therapeutics, improved productivity, and improved levels of exposure to ionising radiations and, that the later, should, perhaps, be assessed on a more regular basis.

Agència d’Avaluació de Tecnologia i Recerca Mèdiques CATALAN AGENCY FOR HEALTH TECHNOLOGY ASSESSMENT AND RESEARCH

SEPTEMBER’09

C ATA L A N A G E N C Y F O R H E A LT H T E C H N O L O G Y A S S E S S M E N T A N D R E S E A R C H

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PROJECTS New evidence-based clinical practice guidelines for the management of stroke, schizophrenia and eating disorders are now available The CAHTA has published three clinical practice guidelines for the integral approach to three pathologies that represent a great challenge in public healthcare. Stroke is a health problem of high prevalence which, in addition, can cause serious disabilities and deterioration of the quality of life. Schizophrenia and other forms of psychosis severely affect the psychological and social development of the affected individuals and their family and social surroundings; whilst eating disorders, anorexia and bulimia nervosa, are disorders that in the last decades have become serious health problems for public health. The three clinical practice guidelines are the result of a thorough extensive review of the literature and an assessment of scientific evidence to issue recommendations for clinical practice. The work has been carried out by teams of professionals from different settings and disciplines, whom have made a considerable effort in the elaboration of these recommendations which are expected to help improve health care. Several different scientific societies and patient associations directly involved in these health problems have actively collaborated in the final revision process of the documents.

Full text available at: www.aatrm.net

www.guiasalud.es

The three documents are part of the GuiaSalud Project (Health Guide Project), the objective of which is to improve the scientific-evidence based decision making and has taken place within the collaborative framework foreseen in the Quality Plan of the National Health System. The guides are presented in different formats and versions including a complete version, a short version and a quick reference guide with action algorithms. All documents also include an information section aimed at patients and family members. Title of the publications and contact persons:



CPG on the Primary and Secondary Prevention of Stroke

CPG on Schizophrenia and Incipient Psychotic Disorder

David Rigau . Iberoamerican Cochrane Centre [email protected]

Imma Guillamón [email protected]

CPG on Eating Disorders Maria-Dolors Estrada [email protected]

Dolors Benítez [email protected]

Perception of school bullying in children and adolescents in 11 European countries The KIDSCREEN European project was designed to develop a health-related quality of life questionnaire in children and adolescents 8 to 18 years old. Bullying has been defined as a repeated and intentional behaviour of physical and/or psychological harassment and this project has made it possible to study the school bullying phenomenon in the participating countries.

Title of the publication: Being bullied: associated factors in children and adolescents 8 to 18 years old in 11 European countries”. Pediatrics 2009; 123(2):569-77. For further information: www.kidscreen.org

The study concludes that the likelihood to perceive school bullying was more frequent among younger children and those who suffer from physical health problems such as obesity or mental health problems, lack of social support, or an unfavourable family socioeconomic situation. In addition, the frequency of the phenomenon has varied amongst analysed countries. The profile of the individual that feels bullied in this study could be useful in the future to identify potential cases among the group of children and adolescents at the highest risk. Finally, the study shows the need to use an interdisciplinary approach in the prevention and early detection of the problem, both from the perspective of the schools and the health services, the family, the media, and society in general.

Contact Person: Luis Rajmil [email protected]

PROJECTS The Shared Clinical Record has consolidated in Catalonia

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Shared medical records improve and facilitate the work of healthcare professionals by enabling them to use available patient information in the different healthcare centres in Catalonia.

The implantation of Information Technology and Communication (ITC) in the Catalan health service offers an unprecedented opportunity aimed at improving healthcare and the efficient management of health centres. In this sense, computerisation of the medical record, meant to include the set of documents that contain data, information and assessments on the patient´s condition and clinical progress, and the health activity that is generated, is one of the fields that might benefit the most from the potential offered by ITC. In Catalonia, the Department of Health has started a project entitled Shared Clinical Record (HC3) aimed at enabling access to the most relevant information necessary to offer adequate health care, while respecting the clinical record models previously used and pre-existing information systems at each health institution. HC3 is not a centralised model resulting from the addition of clinical records but a single model that gains access to information registries from different clinical information systems with exhaustive traceability and the necessary safety guarantees. At present, HC3 enables the user to have access to data from primary care centres (such as diagnoses, prescribed medication, immunizations), data from specialised care centres and hospitals (discharge reports, reports from emergency departments, and specialised out-patient care) and data from diagnostic and therapeutic procedures from health care centres or from the Minimum Basic Data Set (MBDS) such as laboratory reports, diagnostic imaging, or other diagnostic tests. The HC3 project is currently being unfolded. Access can be gained to the records of 6,468,810 people and to over 9,200,000 clinical documents pertaining to the Catalan Health Institute, the Maresme and la Selva

areas Health Corporation and to the Health and Social Network of the Santa Tecla area. The objective for 2009 is to set up the HC3 in 367 primary care centres and 52 hospital care centres, which amounts to 86% of primary care and hospital care centres of the Catalan public use network (XHUP). Among the next objectives to be reached the following stand out: 1) the access of citizens to their personal records through the Personal Health File, for which a pilot project in being carried out in a simple of citizens; 2) integration of digital imaging into the HC3; and 3) access to the information of clinical records in other autonomous communities.

In summary, the HC3 project aims to improve the health of citizens through the use of a tool designed to improve and facilitate the work of health professionals, enabling them to share the available information on the citizens and patients in Catalan health care centres. With this initiative, the Department of Health aims to progressively increase de number of services available to health professionals and to citizens. Contact Person: Cristina Garcia [email protected]

PROJECTS Amotosalen, a further degree of safety in transfusional therapy? 4

At present, there are transfusion centres in the Spanish state and in the European Union where amotosalen for inactivation of pathogens is already being used, especially in platelets.

Title of the publication: Amotosalen for inactivation of pathogens for transfusional therapy Full text available at: www.aatrm.net

In the last years, safety measures have stepped up to reduce the risk associated with the transfusion of blood or any of its components. These measures include the use of amotosalen and ultraviolet light (Intercept®) for inactivation of pathogens (virus, bacteria, and protozoa) in plasma and platelets. There has been a sharp decrease in the number of transfusiontransmitted diseases although there is always a residual risk of infection by viruses, for which there are screening tests, or by pathogens, for which no tests are available or are not performed on a routine basis. In these cases, amotosalen may help reduce the residual risk of infection. According to the results of the systematic review, the use of amotosalen for inactivation of pathogens in plasma and platelets for transfusional use is effective and safe. Moreover, hemosurveillance reports subsequent to its commercialization showed good patient tolerance (adults and paediatric) in a total of 14,493 transfusions of platelet concentrates treated with amotosalen in the different states of the European Union. Contact Person: Laura Navarro [email protected]

Would it be advisable to introduce a screening programme for cardiovascular disease in asymptomatic diabetic patients?

Early detection of ischemic cardiopathy in asymptomatic diabetic patients This is the main question to which the report published by the CAHTA is trying to respond. This document is based on the assumption that a screening programme has to meet three basic conditions before it can be assessed. The first assumption is that diagnostic tests should be able to detect the target condition in an early phase before it becomes symptomatic. The second assumption is that they should have sufficient accuracy to avoid a large number of false positives and false negatives. Finally, the treatment of patients with early disease would have to show improved results as compared to delayed treatment in the same symptomatic patients.

Among the main conclusions and recommendations, it must be pointed out that the review of the literature shows no concluding evidence indicating that a screening strategy for coronary disease in asymptomatic diabetic patients*, in combination with coronagraphy and revascularisation, offers improved results in patients with appropriate coronary lesions. Additionally, in diabetic patients who already present signs of cardiovascular involvement, such as those who are candidates to a renal transplant or to cardiovascular surgery of the lower limbs or carotid surgery, it is advisable to assess in detail any coronary involvement prior to surgery. Treatment of cardiovascular risk factors present in diabetic patients should be performed and intensified regardless of the presence of silent myocardial ischemia. * Early detection of silent myocardial ischemia, generally through nuclear medicine testing.

Contact Person: Joan MV Pons [email protected]

Title of the publication: Early detection of ischemic cardiopathy in asymptomatic diabetic patients: examination under the screening principles Full text available at: www.aatrm.net

RESEARCH

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Minority diseases, the target of the 2009 TV3 Telethon “It is estimated that between 3 and 4% of newborns are affected by Minority diseases with an estimated incidence in the European countries between 6 and 8%” Minority diseases encompass a large and diverse group of serious pathologies that affect a maximum of 5 out of each 10,000 inhabitants and that are caused by molecular, biochemical or cellular alterations. It is estimated that between 3 and 4% of newborns are affected by these diseases with an estimated incidence in the European countries between 6 and 8%. The number of individuals affected by each minority For further information: www.fundaciomaratotv3.cat

disease is low, but the group of patients with these pathologies as a whole makes up a numerous group that in Catalonia

CAHTA newsletter will no longer be available in printed format

accounts for approximately 400,000 affected individuals. The TV3 Marathon Foundation has decided that the 2009 edition be dedicated to the procurement of funds to conduct research work in minority diseases. The objectives of the TV3 Marathon are to make people aware of and to disseminate information on a group of pathologies that are not known and are often forgotten due to their low prevalence. We expect to meet this objective by procuring the necessary resources for biomedical research in an area with scanty effective treatments.

After sixteen years, forty four issues and a circulation of 10,000 copies throughout the world, CAHTA’s newsletter will no longer be available in its printed format. CAHTA maintains its commitment to keep you informed of everything that is related to the assessment of health technology with continue publishing in Catalan, Spanish and English. But in pace with modern times, this commitment will be met by making good use of Information Technology and Communication. In one word, we want you to continue enjoying our regular newsletter, and because of that we kindly ask you to provide us with your contact details so that we may continue sending you via electronic mail the table of contents of CAHTA’s newsletter and the link to access the full text. To make this transition easier for you, we have created a questionnaire available on line at www.cahta.net that you are welcome to fill in conveniently and rapidly and where you will see the pop up question “Do you want to receive CAHTA’s newsletter? Subscribe now”. Thanks a lot for your cooperation!!

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TODAY THE DISCUSSION IS... HTA Database exceeds 8,000 entries The Health Technology Assessment -HTA- documentary database is increasingly becoming a key information source to retrieve reports and data on-going projects from other agencies all over the world. In addition, it just accomplished its highest entry score with 8,000 entries, featuring assessment reports, systematic reviews, and financial analyses, the majority of which can be retrieved in full text and free of charge. How to Access the database? - CRD Databases: www.crd.york.ac.uk/crdweb - Health Technology Assessment Database (HTA), through the Cochrane Library www.bibliotecacochrane.net - Metabuscadores Excelencia Clínica www.excelenciaclinica.net and Metasearch TripDatabase www.tripdatabase.com

CAHTA promotes health technology assessment in hospital centres CAHTA offers, free of charge, the possibility to attend 4 hour long in-classroom-practicum courses at different Catalan hospitals with the intention to show the benefits that a discipline such as the assessment of health technologies may provide through methodologies such as systematic reviews, economic assessment, decision analysis, or the evidencebased clinical practice guidelines. By means of these actions, the CAHTA wishes to expand an “assessment culture” among healthcare professionals and the management boards of Catalan hospital centres and, especially, among those professionals who are members of or who participate in commissions or assessment groups on the incorporation or assessment of new health technologies. For further information, please contact Mr. Antoni Parada at: [email protected]

When and how to update a clinical practice guideline? Actualización de Guías de Práctica Clínica en el Sistema Nacional de Salud. Manual Metodológico

This is a question often faced by the groups in charge of developing clinical practice guidelines (CPG). In order to clarify this and other subjects, the CPG Programme of the National Health System (NHS) has published a methodology manual on “Updating GPCs in the NHS”. This new publications accompanies and completes the manual entitled “Elaboration of CPGs in the NHGS”. Both publications are accessible by logging onto: www.guiasalud.es/egpc/manuales.html

GUÍAS DE PRÁCTICA CLÍNICA EN EL SNS MINISTERIO DE SANIDAD Y CONSUMO

Reports and technical queries at CAHTA - Pharmacological treatment of people with Alzheimer´s disease: state of the knowledge - Head X-ray in head injury sustained in children - Is biomedical investment a good investment? Assessing the impact of research on health

Quality Plan for the National Health System - Analysis of the current state of telemedicine services aimed at assessing the viability of a telerehabilitation programme in patients with neurological disability. - Long-term effectiveness of radical prostatectomy, brachytherapy and 3D external conformational radiotherapy in organ-confined prostate cancer. - Analysis of the potential impact resulting from the application of the Bologna framework and the implementation of the official specialties of nursing in this professional group, the institutions where they work, and the health system in Catalonia. - Comparative analysis of tools for the assessment of the competition. Assessing clinical competition: Comparative analysis of two tools (ECOE versus Portafolio)

6th International G-I-N Conference. - The congress will take place from the 1st to 4th November 2009 in Lisbon, Portugal.

PUBLICATIONS OF INTEREST

For further information, please log onto: www.gin2009.net

CONGRESSES

PUBLICATIONS AATRM

- Amotosalen (Intercept®) for inactivation of pathogens in plasma and platelets: use in Spain

- Costs and benefits of Health Technology Information: An updated systematic review. World Health Organization (WHO) - How can the impact of Health Technology Assessments be enhanced? Health Evidence Network (HEN – Health Evidence Network)

CAHTA’S newsletter is a periodical publication distributed without charge. Its aims are the diffusion of the CAHTA’s assessment, research and teaching activities, and to contribute to the dissemination of health technology assessment results. The Agency has the copyright of this document, which can be replayed, distributed and communicated publicly, totally or partially, for any means, whenever a commercial use is not made and its authorship and origin is quoted explicitly.

Please contact the following address if you wish to be given clearance: Catalan Agency for Health Technology Assessment and Research © Agència d’Avaluació de Tecnologia i Recerca Mèdiques ISSN 1697-0438 Legal diposit: B-13011-96

Roc Boronat, 81-95 (second floor) 08005 Barcelona (Spain) Tel: 00 34 93 551 38 88 Fax: 00 34 93 551 75 10 [email protected] www.aatrm.net

COORDINATION Antoni Parada, Carolina Sorribas EDITORIAL COMMITTEE Oriol Solà-Morales, Antoni Parada, Carolina Sorribas, Isabel Parada DESIGN Joana López Corduente

The personal information available to us for the delivery of the CAHTA Newsletter are part of an anonymous file of the Catalan Agency for Health Technology Assessment and Research, named Activity. In accordance to the Organic Law 15/1999, of December 13, regarding the protection of personal data (Official National Bulletin, no. 298, 14/12/1999), and in order to facilitate the updating of your personal data contained in the file, and the right to access, amend or cancel your data, we provide you with a personal data checking and modification system.

INTERVIEW

Carlos Sisternas

Director of Fenin Catalunya

The absence of desirable evidence should not lead to decisions that postpone the incorporation of Health Technologies that are beneficial to society

The Federation has a Commission for the Development and Incorporation of Health Technologies, the primary objective of which is to establish communication channels with health technology assessment agencies. What is the relationship between Fenin and the Spanish Health Technology Assessment Agencies? Fenin represents the sector of health technology in Spain and as such, interacts with the different agents that make up the health system, being among these, Health Assessment Agencies, always in a professional, objective and objective communication manner. How could this relationship be increased and strengthened? Our mission is to provide support to agencies in our role of strategic partners of the National Health System. We firmly believe that a closer collaboration between industryagencies and more information on the working plans is needed in order to achieve a more effective interaction. Closer collaboration links between both entities would enable us for instance to create unified information systems aimed at assessing the efficacy of these innovations. Should companies become involved in the assessment process? Should Fenin become a regular contact interface? Yes, they should. Companies as well as Fenin should become more

involved in the assessment process. Such process should foster the participation of the interested parties in all stages, including health professionals, planning managers/ paying agents of the healthcare services, scientific societies, and patient associations. This measure would decisively contribute to the fast access of patients to effective, reliable and safe technologies. Do you think that a more effective dialogue between the agencies and Fenin would be beneficial to foster R+D? Absolutely. The assessment of health technologies introduces new significant challenges to access the market. This may have a repercussion on the rhythm of innovation in the health technology sector and can therefore have an impact on the consolidation of the industrial tissue capable of promoting productive R+D. As a result, a transparent collaboration in the development of processes and assessment methodologies tailored cut for the characteristics of the products is decisive for a fast dissemination of the technology and for those patients that may have Access to effective, reliable and safe technologies. It must not be forgotten that Fenin Catalunya, within the scope of its territory, has made a positive contribution towards a better understanding between the industry and the administration, and has facilitated the implantation of essential regulatory mechanisms.

and agencies would be to try and determine the optimal time at which to carry out the assessment. In addition, it should be taken into account that companies are capable of generating clinical evidence based from the very early phases of the life cycle of a certain technology, which can no doubt be of great help. How and in which way does Fenin support the implantation of Information Technology and Communication (ITC) in the Spanish health system? Fenin is present in different forums showing the landmark of its collaborative spirit. Probably, ITCs are a type of technology that is progressing tremendously in the health sector. Here at Fenin we are aware of the value that ITC provides and firmly believe that its implantation will play a determining role to increase the productivity and quality in our sector. Finally, and from your perspective, what would you ask of a Health Technology Assessment Agency?

Could Fenin contribute to a faster or earlier evaluation of some products?

In our opinion, a greater coordination among the different agencies that exist in our country would be needed. The standardisation of methodologies is another relevant aspect as it is important to define what parameters and criteria must be followed at the level of the national health system and at the level of all autonomous communities in order to appraise whether a technology is truly innovative and what added value it provides, thus allowing to meet equity and access criteria whilst ensuring the best health care to all citizens.

An assessment process should be completed within a time framework that is accordant to the pace of evolution of health technologies. Precisely, one of the characteristics of these technologies is that they are short-lived, meaning a short life cycle (normally up to 18 months in the market). One of the objectives of communication between companies

In one word, what is required is transparency and pragmatism above all. The absence of desirable evidence (a frequent occurrence due to a number of reasons, one of these being the impossibility for this methodology to reach the market) should not lead to decisions that postpone the incorporation of health technologies that are beneficial to society.

Opinions expressed in the interview are not necessarily shared by CAHTA’s Newsletter

What is the mission and role of Fenin? Fenin is a nationwide organisation with over 500 members (independent companies, associations and collaborating companies), whose main line of work is the manufacturing and distribution of healthcare products, excluding drugs, supplying mainly the Spanish health system. The main role of our federation is to coordinate, represent, manage, foster and defend the general and common interests of our associate members.