CONTENT: NEWS IN PRO PRO TRANSLATIONS NEWS IN HEALTH... NEWS IN EPIDEMIOLOGY NEWS OF COPERA CURRENT RESEARCH...		Delivering excellence in Patient Reported Outcomes, Health Economics, and Epidemiology from offices in Oxford, Bethesda and Vancouver. NEWS IN PATIENT REPORTED OUTCOMES: Our PRO team in Bethesda, MD The Oxford Outcomes office in Bethesda is in its second year of operation. The Bethesda office currently has a team of six staff, led by Kathy Beusterien. This team specialises in PRO research to support strategy and trial design, measure selection, measure development and validation, analysis and interpretation of PRO data, and research to support labelling and marketing claims. The team has extensive experience of performing patient preference studies and utility assessments to inform inputs into cost-effectiveness models. In addition, the team has applied conjoint analysis to assess the tradeoffs patients are willing to make among various product features and identifying those features that are most influential in choosing selected products. Given the breadth of our experience in both PROs and health economics, we are able to perform comprehensive literature reviews in outcomes research and clearly identify respective unmet needs for target conditions. Our PRO services include: PRO questionnaire development FDA PRO dossiers Patient preference/utility assessments Conjoint analysis (e.g., discrete choice experiments) Literature reviews/meta-analyses We move into new offices in January in order to allow expansion. Our new contact details will be: Oxford Outcomes Inc. Air Rights Center, West Bldg, Ste 250 7315 Wisconsin Ave. Bethesda, MD 20814 tel: +1 (301) 659-4305 fax: +1 (202) 280-1019 Contact Kathy Beusterien for more information. PRO training courses We have recently launched a series of PRO training modules that are geared towards the differing needs of a range of audiences. We have developed introductory courses for clinical and marketing teams, as well as advanced courses for outcomes research teams. These courses take full account of recent FDA draft guidance and findings from recent FDA decisions, taking advantage of Oxford Outcomes' experience and expertise. PRO TRANSLATIONS: ISPOR contributions in Patient Reported Outcomes Diane Wild is leader of the ISPOR taskforce for Translation and Linguistic Validation. This team is tackling key issues related to the translation and linguistic validation of PRO measures including: Developing country-specific language versions of PRO measures Rationale and methods for psychometric validation of translated measures. Oxford Outcomes' Translation and Linguistic Validation Team also has an ongoing program of research to support the work of the ISPOR task force covering: Cultural specificity of response scales Use of the “universal approach” in developing single language translations for multiple countries (especially relevant in the development of Spanish, French, English, and Chinese for multiple countries). NEWS IN HEALTH ECONOMICS: Neil Hawkins joined Oxford Outcomes in February 2007. He adds to our expertise in evidence synthesis techniques for health technology assessment and has research interests in value-of-information analysis in development portfolio management and incorporating individual patient variation in cost-effectiveness analyses of treatment sequences for chronic diseases. More details on our capabilities in mixed treatment comparisons are presented elsewhere in this newsletter. Other senior staff in health economics include Andy Briggs, Mark Sculpher, Maggie Tabberer, David Scott, and Andy Davies. Richard Pitman, based in our Oxford office, is taking the lead in developing our capability in transmission modeling for infectious diseases, an expertise that we believe is unique to Oxford Outcomes. Richard has experience in this area having worked previously at the UK Health Protection Agency, modeling the impacts of a range of healthcare interventions on pandemic influenza, tuberculosis and SARS. Alison Davie joined Oxford Outcomes' Vancouver office as a health economist from i3 Innovus in April 2007. Alison gained her masters degree in Economic Evaluation in Healthcare from City University, London. Alison has five years experience in incorporating decision analytic modeling and probabilistic sensitivity analysis into a number of cost-effectiveness studies. She has worked in a wide range of therapeutic areas, including: respiratory disease, spasticity, oncology, gastroenterology, opioid dependence, and infectious disease. She has prepared submissions to NICE (UK), the SMC (Scotland), and the PBAC (Australia). In addition, Alison has produced value dossiers as aids for reimbursement and pricing in several European countries. Stuart Mealing joined Oxford Outcomes' Oxford office in September 2007 from the Peninsular Technology Assessment Group (PenTAG), University of Exeter where he had worked on a variety of modeling and health technology assessment (HTA) projects; being directly responsible for two HTA models for NICE in the United Kingdom. During his time with PenTAG Stuart gained experience of the technology appraisal of medical devices as well as pharmaceuticals. Stuart is a confirmed Bayesian and as such his primary methodological interest is statistical decision theory in general and value of information in particular. Other areas of interest include survival analysis and the modeling of uncertainty. Following in the successful footsteps of Beth Woods, who joined us in 2006, Maureen Watt has joined our graduate trainee programme and has joined the MSc programme at City University, London. Previously, Maureen was employed as a statistician at the Scottish Executive. Our health economics workshops continue to be in demand. In addition to our off-the-shelf modules, recently commissioned workshops have covered a variety of subjects at differing levels, from introductory health economics and health technology assessment courses, to advanced methods for economic evaluation. We also provide update courses for a number of companies as an ongoing service. NEWS IN EPIDEMIOLOGY: Our Epidemiological portfolio continues to grow with our team led out of Vancouver by Adrian Levy, with support from Shelagh Szabo, Kathy Beusterien, and Neil Hawkins. Developments in database analysis Health information is increasingly being centralized in various forms of computer databases, including disease and treatment registries, administrative records (e.g., prescription claims, hospitalizations, and physician billing), and clinical trial reporting. These databases often present an ideal substrate on which to estimate the efficacy, adherence, and safety of a medication or healthcare interventions. Developing tractable questions and unbiased answers using such databases requires a conceptual understanding of: the development of health databases, data collection methods, database management and analysis, statistical modeling, different understanding between experts, contextualization, and central coordination. Oxford Outcomes has continuously-broadening experience of a wide range of health databases for clinical and observational epidemiology, health services research and economic evaluation. We can help develop answerable questions related to a specific topic of interest and have extensive experience publishing the methods and answers in peer-reviewed literature. We can advise on the feasibility of using health databases to address specific questions or broader areas of interest, seek alternative solutions, develop the research question and objectives, and execute analysis plans. NEWS OF COPERA: an international network for market access, health economics, patient reported outcomes, and epidemiology Oxford Outcomes is a member of the international network: COPERA. This consultant grouping is in its second year of formal operation and provides multi-disciplinary expertise in market access, health economics, patient-reported outcomes, and epidemiology across key countries including: US (Oxford Outcomes), Canada (Oxford Outcomes), UK (Oxford Outcomes), Germany (Neos Health), France (JNBD), Norway, Sweden, Denmark and Finland (PharmEcon), Spain (3-D Research), and Italy (Charta). COPERA members are currently working successfully together on a range of multi-national projects. For more information: www.copera.com or contact: Paul Quarterman. CURRENT RESEARCH INTERESTS: Developing the science of endpoint models, conceptual models and conceptual frameworks Oxford Outcomes has developed a workshop on the development and validation of Conceptual Models, Conceptual Frameworks and Endpoint Models for PRO Research. These are essential research tools used by PRO researchers. However, there is considerable lack of agreement regarding their definition, development and validation approach, and utilisation. The workshop clarifies the role of these tools in light of the draft FDA PRO guidance. Exploring the cultural applicability of Visual Analogue Scales The issue of cultural appropriateness of response scales on PRO measures, as well as the items and the scale as a whole, is becoming increasingly important as clinical trials are more likely to be conducted outside of Western Europe and North America, where cultures are more diverse. Through its fieldwork, Oxford Outcomes has become aware of difficulties associated with the use of the Visual Analogue Scales (VAS) in some non-Western countries and is therefore conducting research into the cultural applicability of the VAS, as well as other types of response scale. Anecdotal evidence suggests that the use of VAS scales in India can be particularly problematic and that a numerical scale is often preferred. A literature search revealed a paucity of literature in this area. However, published research revealed that Peruvian and Mexican Americans had difficulties with VAS scales (Lang 2002) but that a sample of Japanese did not (Ueki et al 1999). A few measures have been developed with response options specifically tailored to suit non-Western populations. For example, a scale for use in rural Burkina Faso, gave residents 6cm wooden blocks to line up in order to value differing health states, with 10 blocks representing the worst imaginable health state and 0 the best (Baltussen 2002). Oxford Outcomes continues its work in reviewing the literature in this area and is planning a small primary data collection study in coming months to explore these issues. Developing the Science of Network Meta Analysis It is essential to compare all treatment options when assessing the relative effectiveness and cost-effectiveness of healthcare technologies. Traditional meta-analysis techniques, which focus on individual pair-wise comparisons, do not provide decision-makers with the information required to choose between multiple treatment options.  Network meta-analysis is an extension of traditional meta-analysis in which all treatment options are simultaneously compared, providing information of direct relevance to decision-makers. Oxford Outcomes has developed expertise in network meta-analyses to provide decision-makers with the information they need to make difficult treatment decisions. Oxford Outcomes has extensive experience of network meta-analyses and Bayesian modeling techniques, with recent experience in a wide range of clinical areas including epilepsy, psoriasis and pain relief. These analyses have utilised a variety of data types including continuous, binary, ordinal, and survival endpoints. Developing the Science in Infectious Disease Modeling Some healthcare interventions, such as vaccines and anti-virals, can alter the transmission of disease within the wider population as well as providing protection/benefit for individuals. To fully capture the value of these interventions, cost-effectiveness models must take into account transmission dynamics across populations. Transmission dynamics are often non-linear, counter intuitive and complex in nature; a rich diversity of behavior that is both fascinating and challenging. Modeling these types of systems, and the impact specific interventions may have on them, requires specialized techniques and knowledge ranging from virology, microbiology and immunology through to demography and national public health policy. ^ TOP All contents copyright © 2007 Oxford Outcomes. All rights reserved. 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