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Genetics and Mainstream Medicine Genetics and mainstream medicine Service development and integration March 2011 Author: Hilary Burton Acknowledgements The author would like to acknowledge with thanks the expert guidance and support of Dr Ron Zimmern and Dr Peter Farndon. The initial work was funded by the UK Genetic Testing Network. However, this final report is published independently by the PHG Foundation. This report can be downloaded from our website: www.phgfoundation.org Published by PHG Foundation 2 Worts Causeway Cambridge CB1 8RN UK Tel: +44 (0) 1223 740200 Fax: +44 (0) 1223 740892 © 2011 PHG Foundation ISBN 978-1-907198-07-6 Correspondence to the author: [email protected] How to reference this report: Genetics and mainstream medicine. PHG Foundation (2011) ISBN 978-1-907198-07-6 The PHG Foundation is the working name of the Foundation for Genomics and Population Health, an independent charitable organisation (registered in England and Wales, charity No. 1118664 company No. 5823194), which works with partners to achieve better health through the responsible and evidence-based application of biomedical science. Genetics and mainstream medicine – service development and integration Table of Contents Key policy points ...............................................................................3 1 Introduction ..............................................................................7 2 Background ...............................................................................9 3 Methods ................................................................................. 11 4 Emerging health needs for genetics in mainstream medicine ............... 13 4.1 A focus on inherited or heritable conditions .................................................13 4.2 Wide range and total prevalence of genetic conditions throughout clinical medicine ...........................................................................................13 4.3 Increased diagnosis through screening, family tracing (cascade testing) and good clinical practice ............................................................................14 4.4 Complexity of clinical and laboratory assessment and management .....................15 4.5 Increase in capability for diagnostic testing to deal with increased volume and complexity ...................................................................................16 4.6 Wider utility of genetic testing .................................................................17 4.7 Implications of evolving health needs .........................................................19 5 Policy response to expanding genetic ‘need’ .................................... 21 5.1 Development of commissioning capability and capacity ...................................22 5.2 Development of high quality, specialised and equitable services for inherited conditions ..............................................................................24 5.3 Development of mechanisms (such as clinical networks) to support developing services ............................................................................................25 5.4 Review of genetic test provision ...............................................................26 5.5 Increasing skills and developing capacity in genetics in the health professional workforce ..........................................................................29 5.6 Developing and evaluating methods for family record keeping and cascade testing that can be used within or accessed from mainstream medicine ...............30 5.7 Development and evaluation of models for integration of genetics in other clinical specialties ................................................................................31 5.8 Building audit and research programmes to evaluate effectiveness and cost effectiveness of services ........................................................................33 6 Discussion and conclusions .......................................................... 35 7 References .............................................................................. 38 1 2 Genetics and mainstream medicine – service development and integration Key policy points The development of genetics in mainstream medicine was one of the key themes of the 2003 Genetics White Paper, Our Inheritance, Our Future. Experience during the last seven years, together with the exponential development of technologies as set out in the House of Lords Genomic Medicine Report provide increasing evidence of the challenges of integrating genomic knowledge into clinical medicine. In this paper we provide analysis and recommendations for a strategic response relevant mainly to the management of inherited or heritable disorders. Based on detailed strategic needs assessments in ophthalmology and cardiovascular disease and in consultation with interested organisations, genetic services and individuals we suggest a strategy to strengthen and integrate genetics in relevant clinical specialties. Central to this is the concept that, rather than specialist genetics ‘moving into mainstream medicine’, the clinical specialties should develop and expand to bring a set of new genomic technologies within their specialist remit. This will involve sub-specialisation in inherited conditions within the specialty and development of pathways for appropriate referral from more generalist ‘mainstream’ services as well as appropriate support from specialist genetics. Though the axis of clinical responsibility may shift, regional genetics services are and will remain an essential element of this paradigm. It will thus be vital to maintain the high quality, capacity and integrity of regional genetics services. The current pattern of ‘joint clinics’ in which specialties work side by side with genetic services to provide care for patients with inherited disorders is highly regarded by patients and families. However, provision of such services is not realised equitably across the UK even now and will become increasingly difficult with further expansion of genetics in other clinical services. Further, our detailed policy work with a wide range of stakeholders in these fields leads us to suggest that it is time for the specialties (and those responsible for commissioning them) to include inherited disease within their own remit and appropriately integrate the necessary specialist clinical and laboratory genetic expertise. A strategic response is required to move towards this integrated, specialty led pattern of care. Underpinning this response is the vital role of specialist clinical and laboratory genetics to continue to provide the necessary tertiary and quaternary services, support those providing care for people with heritable disorders in other specialties and help to lead policy development. The strategy will need to be developmental and will take place over a number of years, requiring continuing investment and commitment to service reconfiguration. 3 Evidence of increasing need for genetic aspects of mainstream medicine includes the following: 1. High numbers of patients and families due to greater knowledge of the prevalence of the conditions 2. Further patients identified from population screening programmes and systematic cascade testing 3. New diagnostic methods and treatment options, which can make a significant difference to outcome by enhanced and targeted health surveillance 4. Recognition of complexity of inherited conditions which requires input from both mainstream specialist and geneticists 5. Increasing capability for diagnostic testing with development for higher throughput of testing 6. Wider utility of genetic testing to include reduction in morbidity and mortality, information provision, assisting with reproductive decision making and improving care pathway. We recommend the following prime elements for the strategic response: Comprehensive engagement of specialised commissioners and provision of support to all commissioners in clinical areas where there are substantial elements of inherited disease. Such support should include, on a national basis, the development of commissioning guidance and agreeing clinical pathways involving primary, secondary and specialist elements of care. A programme to reduce the current inequities that exist across the UK in access to high quality services for inherited disease within the various clinical specialties. The response will require increased overall capacity and some service reorganisation to ensure critical mass. The development and strengthening of mechanisms such as clinical networks to support specialised inherited conditions services and to ensure rapid translation of advances and most efficient use of available expertise and experience. There should be a review of genetic test provision to respond effectively and efficiently to increasing demand, rapidly developing capabilities and changing technologies. This should be undertaken in the context of national pathology modernisation and should include how laboratories can best respond to increased demand for testing, how to maintain quality in NHS services, appropriate gate-keeping and the development of mechanisms for requesting, funding and providing genetic tests and how genetic tests should be evaluated and regulated. An increase in the sub-specialist workforce able to provide the specialised elements of services for inherited diseases. This must be accompanied by continuing work to develop competencies in genetics in the health professional workforce with development
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