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are still professionals and companies with genuine commitment to patients with rare diseases such as phenylketonuria. A strong movement is working towards centres of expertise for the treatment of patients with rare diseases, and opportunities exist to allow new and existing pharmaceutical companies to develop orphan drugs. Such developments will further improve treatment and outcomes in future generations of patients, although the risk remains that drug development might lead to a monopoly situation for any successfully developed products. *Francjan J van Spronsen, Terry G J Derks Section of Metabolic Diseases, Beatrix Children’s Hospital, University Medical Center Groningen, University of Groningen, 9700 RB Groningen, Netherlands [email protected]
FJvS has received research grants and consultancy and speaker’s fees from Merck Serono and Danone Nutricia. He is a member of the scientific advisory board of Merck Serono and chair of the scientific advisory board of Danone Nutricia. TGJD has received speaker’s fees from Danone Nutricia and Vitaflo, research fees from Sigma Tau and Vitaflo, and training support from Sigma Tau and Genzyme. 1
Blau N, van Spronsen FJ, Levy HL. Phenylketonuria. Lancet 2010; 376: 1417–27.
Muntau AC, Roschinger W, Habich M, et al. Tetrahydrobiopterin as an alternative treatment for mild phenylketonuria. N Engl J Med 2002; 347: 2122–32. 3 Kure S, Hou DC, Ohura T, et al. Tetrahydrobiopterin-responsive phenylalanine hydroxylase deficiency. J Pediatr 1999; 135: 375–78. 4 Enns GM, Koch R, Brumm V, Blakely E, Suter R, Jurecki E. Suboptimal outcomes in patients with PKU treated early with diet alone: revisiting the evidence. Mol Genet Metab 2010; 101: 99–109. 5 Longo N, Harding CO, Burton BK, et al. Single-dose, subcutaneous recombinant phenylalanine ammonia lyase conjugated with polyethylene glycol in adult patients with phenylketonuria: an open-label, multicentre, phase 1 dose-escalation trial. Lancet 2014; published online April 15. http://dx.doi.org/10.1016/S0140-6736(13)61841-3. 6 Leuzzi V, Pansini M, Sechi E, et al. Executive function impairment in early-treated PKU subjects with normal mental development. J Inherit Metab Dis 2004; 27: 115–25. 7 van Spronsen FJ, Burgard P. The truth of treating patients with phenylketonuria after childhood: the need for a new guideline. J Inherit Metab Dis 2008; 31: 673–79. 8 Hagenfeldt L, Bjerkenstedt L, Edman G, Sedvall G, Wiesel FA. Amino acids in plasma and CSF and monoamine metabolites in CSF: interrelationship in healthy subjects. J Neurochem 1984; 42: 833–37. 9 Jahja R, Huijbregts SC, de Sonneville LM, van der Meere JJ, van Spronsen FJ. Neurocognitive evidence for revision of treatment targets and guidelines for phenylketonuria. J Pediatr 2014; published online Jan 30. DOI:10.1016/j. jpeds.2013.12.015. 10 Weglage J, Fromm J, van Teeffelen-Heithoff A, et al. Neurocognitive functioning in adults with phenylketonuria: results of a long term study. Mol Genet Metab 2013; 110 (suppl): S44–48. 11 Okano Y, Nagasaka H. Optimal serum phenylalanine for adult patients with phenylketonuria. Mol Genet Metab 2013; 110: 424–30. 12 Hoskins JA, Jack G, Wade HE, et al. Enzymatic control of phenylalanine intake in phenylketonuria. Lancet 1980; 315: 392–94.
Adoption of electronic health records in UK hospitals: lessons from the USA The UK–US Government Memorandum of Understanding on health information technology signed earlier this year could be the first sign that the UK will finally develop a sustainable strategy to promote the adoption of hospital electronic health records (EHRs).1,2 This digital infrastructure is important to help hospitals deliver safer, more patient-centred, and efficient care, and also to support audit, quality improvement initiatives, public health, health-service planning, and research. Although the UK and US have different health systems, the success of the Health Information Technology for Economic and Clinical Health (HITECH) Act in making information technology an integral part of US health care offers the UK important, transferable lessons.3,4 Shortly after the UK Government launched the illfated National Programme for Information Technology (NPfIT),5 then President George W Bush promised in his 2004 State of the Union Address that most Americans would have EHRs within 10 years.6 Although that seemed ambitious at the time, this goal has largely been 8
achieved.7 The focus of efforts in the USA has now shifted from getting technology adopted, to how EHRs can be used to drive clinical and economic returns.8 By contrast— and despite being the first mover on health information technology—the UK is still struggling with laying the foundations for hospital EHRs.9 What explains these contrasting experiences? A key factor is that the UK pursued a top-down implementation strategy, in which central Government signed substantial contracts with a handful of EHR vendors,9 whereas the USA pursued a more bottom-up strategy, in which hospitals and health professionals were given choice of which EHRs to procure and then were incentivised to make their own choices. In the USA, the phased “meaningful use” strategy used the idea of an escalator to move from data capture (stage 1) to clinical processes (stage 2) to improved outcomes (stage 3);8 US hospitals that do not make the conversion receive lower reimbursements from federal payers, which incentivises even the slow adopters to move. www.thelancet.com Vol 384 July 5, 2014
What lessons might the UK learn from these US experiences? Foremost, the UK needs a detailed strategy for health information technology to fill the current post-NPfIT policy void. This strategy needs four key components. First, the need to devolve as much of the decision making process about which health information technology systems to procure to the front-line in hospitals; trusting health hospital management and health professionals will help achieve buy-in, promote engagement, and charge them with the responsibility to succeed. Second, the UK central Government can promote this transition through moderate financial incentives of the kind recently started through NHS England’s Integrated Digital Care Technology Fund.10 In the USA, the cost of incentives to hospitals is a small fraction of the total costs of the information technology systems, but is enough, especially when tied to promises of penalties later for non-adoption, to move hospitals along.8 Third, the UK Government needs to play a part in setting the wider rules of engagement—for example, establishing certification criteria and standards for interoperability—to ensure that the information technology meets basic safety thresholds and that data can be shared across NHS providers. Finally, there needs to be the equivalent of the US Office of the National Coordinator for Health Information Technology that is charged with spearheading this agenda at the national level to ensure that it remains atop the policy agenda. Financing such a strategy is obviously challenging, but the return on investment is likely to justify it in the long run. The up-front costs will be substantial and wild promises—like those made previously by UK politicians about achieving improvements in life expectancy or dramatic cost savings early on—should be avoided.5 We know from UK general practice, which went electronic two decades ago, that a digitised infrastructure can increase the efficiency with which quality assessment, epidemiological research, evaluations of public health evaluations, and clinical trials can be undertaken.11 Furthermore, having a comprehensive cradle-to-grave EHR infrastructure would substantially increase the appeal of the UK to industry, since such research cannot easily be undertaken on scale in the fragmented delivery model that characterises the USA.3 The UK led in implementation of health information technology in primary care, but its efforts in implementing
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EHRs in secondary care have not yet succeeded. The UK should learn from the successes in health information technology in the USA. The stakes in this policy game are high, and it is vital to learn from trans-Atlantic experiences to leverage the new digitised infrastructure to deliver more patient-centred, equitable, and costeffective health care.3 *Aziz Sheikh, Ashish Jha, Kathrin Cresswell, Felix Greaves, David W Bates eHealth Research Group, Centre for Population Health Sciences, Medical School, University of Edinburgh, Edinburgh EH8 9AG, UK (AS); Harvard Medical School, Boston, MA, USA (AS, DWB); Department of Health Policy and Management, Harvard School of Public Health, Boston, MA, USA (AJ, FG, DWB); School of Health in Social Science, University of Edinburgh, Edinburgh, UK (KC); and Division of General Internal Medicine and Primary Care, Brigham and Women’s Hospital, Boston, MA, USA (AS, DWB) [email protected]
AS and FG are supported by The Commonwealth Fund. AS led several of the independent national evaluations of the UK’s National Programme for Information Technology, including the evaluation of the implementation and adoption of NHS Care Records Service into NHS hospitals. KC was the project co-ordinator for evaluating the implementation and adoption of NHS Care Records Service into NHS hospitals. DWB chaired the Independent Project Steering Committee of the evaluation of the NHS Care Records Service into NHS hospitals and is a member of the Health Information Technology Policy Committee of HITECH. 1
US Department of Health and Human Services. US and UK working to strengthen use of health IT for better patient care. Jan 23, 2014. http://www. hhs.gov/news/press/2014pres/01/20140123a.html ( accessed June 2, 2014). 2 The Lancet. The NHS IT nightmare. Lancet 2011; 378: 542. 3 Blumenthal D, Dixon J. Health-care reforms in the USA and England: areas for useful learning. Lancet 2012; 380: 1352–57. 4 Blumenthal D. Wiring the health system—origins and provisions of a new federal program. N Engl J Med 2011; 365: 2323–29. 5 Department of Health. Delivering 21st century IT support for the NHS: national strategic programme. London: Department of Health, 2002. http:// webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov. uk/en/Publicationsandstatistics/Publications/ PublicationsPolicyAndGuidance/DH_4008227 (accessed June 20, 2014). 6 The White House. Transforming Health Care: The President’s Health Information Technology Plan. Jan 20, 2004. http://georgewbushwhitehouse.archives.gov/infocus/technology/economic_policy200404/ chap3.html (accessedJune 2, 2014). 7 DesRoches CM, Charles D, Furukawa MF, et al. Adoption of electronic health records grows rapidly, but fewer than half of US hospitals had at least a basic system in 2012. Health Aff (Millwood) 2013; 32: 1478–85. 8 Blumenthal D, Tavenner M. The “meaningful use” regulation for electronic health records. N Engl J Med 2010; 363: 501–04. 9 Sheikh A, Cornford T, Barber N, Avery A, Takian A, Lichtner V. Implementation and adoption of nationwide electronic health records in secondary care in England: final qualitative results from a prospective national evaluation in “early adopter” hospitals. BMJ 2011; 343: d6054. 10 NHS England. The Integrated Digital Care Technology Fund. 2014. http:// www.england.nhs.uk/ourwork/tsd/sst/tech-fund/ (accessed June 2, 2014). 11 Avery AJ, Rodgers S, Cantrill JA, et al. A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis. Lancet 2012; 379: 1310–19.