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National Health Service History
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| Background | Year | NHS Events |
| Gordon Brown PM Global financial crisis Burma cyclone/Chinese Earthquake Beijing Olympics Russian/Georgian conflict | 2008 | Alan Johnson SOS Regional (Darzi) reviews Final Darzi Review Report, High Quality Care for All |
| Israeli invasion of Gaza strip Barack Obama President of USA Parliamentary/MP financial scandals UK Population 61 million Copenhagen climate conference | 2009 | NHS Constitution Mid-Staffs Report on poor quality health care Care Quality Commission takes over from Healthcare Commission Andy Burnham Secretary of State for Health Financial stringency Swine flu concern and mass immunisation Prime Minister's Nursing Commission |
| Haiti earthquake Obama's historic US healthcare plan Election - LibDem/Conservative coalition, David Cameron PM Gulf of Mexico BP Oil spill IPad launched | 2010 | Andrew Lansley SOS Equity and Excellence, liberating the NHS Healthy Lives, Healthy People - public health White Paper Royal Centre for Defence Medicine (Birmingham) replaces military hospitals |
| "Arab Spring" uprisings in Tunisia, Egypt, Yemen, Syria and Libya Japanese earthquake/tsunami/nuclear power station problems Widespread riots in English cities Euro/Greek financial crisis | 2011 | Health and Social Care Bill "20 Trusts with major cash problems" |
| London Olympics | 2012 | |
| 2013 | ||
| 2014 | ||
| 2015 | ||
| 2016 | ||
| 2017 | ||
The decade opened with a world wide financial problem that rapidly escalated. A crisis in the USA caused by "sub-prime" mortgage loans, repackaged as 'derivatives' on which there was default, escalated into global economic recession. Tax revenues fell and social security payments rose. The housing market was depressed and unemployment rose, particularly among the young. The technological new generation did not establish themselves or start a family as early as their parents. The wave of British immigration slowed in 2008 as the country became less attractive to migrants, although future estimates of population suggested a significant continuing rise. Public sector workers took strike action. The United Nations eight millennium development goals, for example combating hunger, child mortality and AIDS, were unlikely to be met as rising food prices and the cost of oil pushed millions more into poverty. Conflict in Iraq subsided, in Afghanistan increased and in 2011 uprisings against autocratic regimes in Tunisia, Egypt, Libya and Syria followed each other. Natural disasters like the earthquake in Haiti with 200,000 dead stretched aid agencies. The election of a new US president in 2008, Barrack Obama did not solve financial problems or those of the middle east or terrorism. However a historic decision under Obama set in train a continuing process of extending coverage to almost all of the legally resident USA population, and created incentives to contain the unaffordable growth of US health care costs. .
Labour's control of the NHS throughout the previous decade ended. The economy was the major issue and in May 2010 Labour polled far fewer seats than the Conservatives who, in coalition with the Liberal Democrats, formed the new government. All agreed that the deficit should be reduced. Social attitudes were changing; there should be "no more something for nothing". Public satisfaction with the NHS was, however, increasing. The National Centre for Social Research had conducted annual surveys since 1983. When Labour entered office in 1997, only a third of people (34%) were satisfied with the NHS. By 2009, satisfaction stood at 64%, the highest level since the survey began. The reduction in waiting times for hospital inpatient and outpatient services was primarily responsible and the increased allocations to the NHS had probably helped.
Health services internationally were hit by a perfect storm. Money was tight but people's expectations were increasing in a "me too" society. Technology was providing a growing number of expensive treatments, radiotherapy was far more precise and effective, imaging of a quality unbelievable only years previously and some forty new drugs for cancer were in the offing, each costing some £2-3,000 a month. The population was aging, bringing increased costs, and death was seen as optional, to be postponed if enough money was spent. How could one pay for the triumph of medicine?
In 2010 the Royal Mail issued a "medical breakthroughs" stamp set, using medical imagery to illustrate six advances: beta-blockers, penicillin, hip replacements, artificial lens implants, malaria parasites and CT scanners.
The anniversary in 2008 was widely commemorated. Health Service Journal listed the 60 people considered most influential, Bevan being the winner. Few publications celebrated clinical developments or the improving service to patients. Most dealt with macro issues of politics and funding. The House Magazine (of Parliament) produced a supplement on the Secretaries of State of the last 30 years and articles by them. Frank Dobson attacked the health policies of his party and its accent on the market place. Alan Milburn believed that devolution had not proceeded far enough and suggested that the better local authorities might undertake health service purchasing. The King's Fund produced an analysis of changing workload, finance and waiting times over 60 years. The Nuffield Trust published Rejuvenate or Retire, views of the NHS at 60 in which senior figures mused on the past performance and future possibilities. All agreed that it should remain taxpayer-funded & free at the point of use. Even those believing in the insurance model did not think it would happen. When radical alterations had been raised 20 years previously with Mrs. Thatcher, Sir Kenneth Stowe then Permanent Secretary, recalled her saying "There is no constituency for change." Most agreed with the purchaser-provider split, that the private sector offered important competitor services within the NHS, and that more decisions should be taken locally.
The four UK Health Ministers restated the principles of the NHS.
A comprehensive service available to all
Access to services based on clinical needs and not on the ability to pay
Aspiration to high standards of excellence and professionalism
NHS services must reflect the needs and preferences of patients, their families and their carers
Working across organisational boundaries with other organisations in the interests of patients, communities and the wider population
Commitment to the best value for taxpayers' money, making the most effective and fair use of finite resources
Accountability to the public, communities and patients that it serves.
The Conservatives' Patient's Charter enshrining patients' rights was followed by a Labour 'constitution' for the NHS, pulling together existing rights, responsibilities and pledges, the right to make choices about their care, including choosing their general practice and expressing a preference for a particular doctor and the right to drugs and treatment recommended by NICE, if approved by the patient’s doctor, and "to expect local decisions on funding of other drugs and treatments to be made rationally following proper consideration of the evidence." When published in January 2009 the response was lethargic. Financial storms were gathering; the Chief Executive's report for 2008-9 said that "we will need to release unprecedented levels of efficiency savings between 2011 and 2014 – between £15 billion and £20 billion across the service over the three years."
A new emergency phone number, 111, was introduced in the north east in 2010 to improve access to non-emergency services , to be rolled out over the country replacing the NHS Direct telephone number. Staffed by call advisers supported by nurses, needs would be assessed so they received the right service as quickly as possible, guiding patients to a locally available service or advice and information. It would be used when help was needed fast, but not for life threatening problems, perhaps outside of GP surgery hours and for people away from home. Calls would be automatically routed to a centre with local information. Call advisers would be reliant on a computer decision system, NHS Pathways. The clinical content was governed through a national clinical reference group chaired by the Royal College of General Practitioners. It ensured that callers had their needs assessed consistently. People were then given advice and the handler might be able to book some services directly, or deploy an ambulance.
Internet was now a major source of health information. Patients had reliable information from the NHS Choices. There was health advice and information and assistance in choosing healthcare providers, a self help guide which might lead one to consult a doctor and health encyclopaedia. 'Dr Foster' launched its own hospital and consultant guide that had far more specific information on hospitals and individual consultants. Because so many people used Wikipedia, for example to explore the options for treating cancer, it became important to maintain its accuracy and Cancer Research UK undertook to edit and update articles. Even 19th Century archive material, such as the British Medical Journal and the Lancet, was available online and at PubMed.
Pressure for change of the NHS IT programme increased with reports from the Audit Commission and the Public Accounts Committee. Hospital trusts could now install their own system if compatible with the national network. Suppliers and the government were locked in contractual disputes and the philosophy and ambitions of the programme were questioned. In 2009 the first Summary Care Records (a secure electronic summary of key health information derived initially from the patient’s GP record began to be rolled out across the country. In the 2010 Pre-Budget Report the programme was scaled back. Money would be saved by abandoning uniform software if hospitals already had a system fit for purpose. The successes, NHSmail, PACS and Choose and Book, were overshadowed by the now admitted failure of the core innovation, a standard centrally procured electronic records system across secondary care. However few other countries had been more successful in the introduction of a national system. In October 2010 the Department consulted on new proposals, Liberating the NHS - an Information Revolution. .Progress remained slow and the Audit Commission (2011) doubted if the centralised top-down system could ever be made to work at justifiable cost. In August 2011 the Public Accounts Committee examined the delivery of care records systems under the National Programme for IT and said that the central spine and e-record for all patients was unworkable, that major parts of the NHS were already using local and effective systems of intercommunication not compatible with other systems, and ambitions should be curtailed to prevent waste of money. The cost, up to March 2011, had been £2.7 billion. The Cabinet Office’s Major Projects Authority said that the National Programme for IT had not and could not deliver its original intent. The dismantling of the programme would be accelerated and be replaced by cheaper regional systems, the Board managing it abolished, and control returned to the Department.
| Alan Johnson 2007- 2009 (Labour) |  | |
| Andy Burnham June 2009-May 2010 (Labour) | NHS 2010–2015: from good to great. preventative, people-centred, productive. (Operating framework 2010). |  |
| Andrew Lansley May 2010 (Conservative/LibDem coalition) | Equity and Excellence, liberating the NHS (July 2010) Healthy Lives, Healthy People (November 2010) Health and Social Care Bill (2011) |  |
Liberal/Conservative health policy - Equity and Excellence, liberating the NHS
Labour had introduced four important innovations, foundation trusts, greater NHS use of the independent sector, patient choice and payment by results. R G Bevan wrote that 'healthcare systems had three main goals, to control total costs, to achieve equity in access by need and to achieve excellence in performance (short waiting times, satisfied patients, and good outcomes). BMJ 2008;337:a935. To achieve this incentives were needed. Since 1976 the NHS had controlled costs with a cash limited budget and sought equity by distributing funds to populations in relation to their needs. The problem was improving the performance of providers. Before 1991 the NHS had a hierarchical integrated model in which the same organisations were responsible for meeting the needs of their populations and for running providers. Such organisations could be funded equitably for their populations or for the performance of providers, but not both. The internal market with a purchaser-provider split, in which purchasers were funded for their populations and contracted with independent providers, was an attempt at an answer. England had tried four variations of this model to try to improve provider performance, competition between 1991 and 1997; partnership between 1997 and 2000; publishing performance in "star ratings" between 2001 and 2005; and again competition from 2006, changing the methods of payment.
In June 2008 the Audit Commission published "Is the Treatment Working". The development of foundation trusts and patient choice was behind schedule and the scale of independent sector treatment centres was limited. Scotland, Wales and Northern Ireland had different approaches. In 2009 Nuffield reviewed their experiences, suggesting that England was comparatively more efficient, spent less on healthcare and had fewer doctors, nurses and managers per head of population and was making better use of the resources it had in terms of higher levels of activity, crude productivity of its staff, and lower waiting times. The King's Fund, in Understanding New Labour's Market Reforms (2011), (summary) felt that they had gone much further in introducing market competition than the Conservatives in the 1990s and the fears voiced were largely not realised, but their impact was also more limited than their proponents had hoped. The NHS "was still some distance away from functioning as a fully fledged provider market for publicly financed care. The system continued to be run by a closely managed hierarchy, while operating in a more market-like way in specific respects." Hawkes said that the reforms had emerged piecemeal, for while there were policy statements, a clearly articulated plan was never put before parliament or the electorate, in part because it avoided a showdown in the Labour Party ranks, not least between Blair and Brown. 'The reforms worked but the politics of the reforms was a disaster.'
In May 2008 Darzi published ‘Leading Local Change’ (The Next Stage Review) and his final report, High Quality Care for all, appeared at the time of the 60th anniversary. It was followed by separate strategies on primary and community care, workforce issues (A High Quality Workforce), and informatics. A major effect of the clinical slant of the Darzi proposals was to modify the way hospital (and community) health services might be organised. The King's Fund summarised High quality care for all - the final report of the Darzi review
London Darzi reports | National Darzi Reports |
| The Case for Change (2006) | |
| Saws and Scalpels (2007) -clinical change | Interim Report (October 2007) |
| A Framework for Action (July 2007) | Leading Local Change (the Next Stage review May 2008) |
| A local hospital model for London (November 2008) | High Quality Care for All - The Next Stages final report (June 2008) |
| Stroke & Trauma consultation (February 2009) | An immense number of working papers were also produced, not listed here |
Andy Burnham who became Secretary of State in 2009 was a cast-back to Frank Dobson and the old left. Different parts of the Department of Health did not seem to speak to each other and policies seemed increasingly chaotic. The use of competition to drive innovation, quality and choice as espoused by Paul Corrigan, an architect of the Blair reforms, was now unappealing to No 10. Speaking to the King's Fund in September 2009, Burnham said that the NHS not the independent sector, was the 'preferred provider'. Unite, Britain's biggest union and a major funder of the Labour Party, had petitioned the government to "roll back the privatisation of the NHS", & seemed to have influenced the Secretary of State and claimed a major victory. Andy Burnham argued that reform meant working to improve existing services where they were 'good enough'. The voluntary sectors appealed to the Cooperation and Competition Panel. When the election came, Labour made little capital out of its undoubted successes in the health service.
The 2010 election led to a Conservative/Liberal Democrat coalition with an agreed policy. The appointment of Andrew Lansley as Secretary of State, who had shadowed health for many years in opposition, was welcomed by professional organisations. Lansley, a man of broad concepts rather than fine detail and an impressive record in achieving his goals, arrived with a draft White Paper in his pocket. His proposals had been trailed heavily when the Conservatives published NHS Autonomy and Accountability - proposals for legislation in 2007. When this was cut and pasted into the White Paper, those that had not been paying attention were shocked by their scale. So began perhaps the messiest reorganisation the NHS had ever undergone, although the two green papers and white paper of 1968-72 prior to NHS Reorganisation (1974) was a close second.
Lansley said that government 'would not let the sick pay for Labour's debt crisis' and the health service budget would be ring-fenced. NHS finances would be tight and management costs had to be reduced. Less stress would be based on targets some of which were soon modified, reducing the management effort required. One of his first actions was to reassess the Darzi-inspired London NHS restructuring, criticised by GPs who objected to the central role it gave to new polyclinics and by acute trusts that questioned the estimates of huge reductions in acute activity as care was shifted out of hospitals. The Chair of NHS London resigned in protest at bringing to a halt much useful work. His vision of the future of London's NHS differed from that of the Secretary of State who outlined new criteria for decisions on service changes, support from GP commissioners, strengthened public and patient engagement, clarity on the clinical evidence base and consistency with current and prospective patient choice.
In July 2010 Andrew Lansley published his White Paper; Equity and Excellence, liberating the NHS. The major themes of the Coalition strategy built on the internal/social market model. The Conservative administration in 1990 had been in power for ten years before it started substantial reform, and Labour six years before it had done so in 2002. Now, the Chief Executive of the NHS said 'nothing in the system is left untouched' (speech 6 October 2010 to FTGA). The Coalition had taken 50 days and there had been no warning in speeches, manifestos or even the coalition agreement of the scale of the changes though Autonomy and Accountability had contained many of them. The changes were criticised by some as creating unnecessary turbulence, for their potential costs, and the delay that might be imposed on desirable developments already in hand. Opinion was unconventionally split, with ex Labour advisers supporting the proposals and right wing think tanks opposing them.
The Bill's stated aims were to
The 'vision' was a service delivering good outcomes and devolving decision making to the front line. Some feared that the encouragement of "any willing or qualified provider" presaged more "privatisation" of the health service. National and regional specialist services would be commissioned by a new NHS Commissioning Board taking over many SHA functions. SHAs and primary care trusts would be abolished. On the commissioner side, 500-600 consortia of GPs would take responsibility for most of the NHS budget, transferred from PCTs. The Royal College of General Practitioners approved of this in principal. No other country had placed such emphasis on GP purchasing. Lansley's 2007 paper had said "We support the return of powerful, clinician-led commissioning in primary care – like that engendered by GP fundholding in the 1990s." On the provider side, NHS foundation trusts would have greater autonomy and independent sector providers will be encouraged to compete for patients. There would be no cap on the income NHS trusts could generate from private practice. The operation of the market would be overseen by an economic regulator, a new role for Monitor. Its would promote competition, regulate the prices paid to providers and ensure continuity of service provision. Public health functions would move to Local Authorities who would employ a director of public health & have a ring fenced public health budget to allocate. Local authorities would also be given control over local health improvement budgets and the power to agree local strategies to bring together the NHS, public health, and social care. Council-based public health teams would be well placed to provide GP commissioning consortia with information, evidence, needs assessment, and the quality improvement support they will need to commission high-quality, integrated health services. Local authorities would establish Health and Wellbeing Boards, intended to lead on improving the strategic coordination of commissioning across NHS, social care and related children’s and public health services.
Patients would get more choice and control, backed by a information, so that services
were more responsive to patients and designed around them. They would be able to choose their GP practice regardless of where they lived, and choose between consultant-led teams. More comprehensive and transparent information would help them make these choices together with healthcare professionals. Management costs would be reduced so that as much resource as possible supports frontline services. The NHS would aim for outcome measures of quality rather than process measures or targets, GPs and hospitals having to publish detailed outcomes of their care, including medical errors. A new set of outcome measures for A & E units were soon published and the 4-hour standard was abandoned.
Sir David Nicholson, the NHS Chief Executive, outlined the steps to ensure a smooth transition.(July, September) PCTs could be merged, perhaps if staff began to move. Separate commissioning and provider functions were established within the Department and within the SHAs to guide implementation.
The King's Fund the speed and extent of reforms were ambitious and risky and its Chief Executive, Chris Ham, writing that the changes took forward reforms set out by Labour in 2002 and developed by Ara Darzi in 2008. Following consultation on the White Paper, a number of modest changes were made to the proposals, more details were fleshed out and the Bill was published in January 2011. It was long and complex, in its essentialsmodifying previous legislation. Critics thought the changes were going too far and too fast; but delaying the establishment of a new structure when the old was rapidly disappearing as staff left, might not improve matters. Labour, health trade unions including the BMA and the RCM were strident in their comments. The Royal College of General Practitioners supported the placement of GPs at the centre of commissioning but was concerned at the loss of existing expertise. In April 2011 the all-party Commons Health Select Committee, in a thoughtful review, demanded significant changes to accountability and that places commissioning bodies 'should 'reflect the range of other (clinical and non-clinical) considerations' including nurses and secondary care doctors. Commissioners must be able to facilitate necessary service reconfigurations. The reforms lacked a 'strong narrative about why the inevitable upheaval they involve will be worthwhile. The arguments often seemed either highly complex and technocratic or vague. Reducing bureaucracy is a popular idea, but it is not strong enough and the argument that the NHS has poor outcomes has often unravelled. The government had not made the case that this particular set of reforms is the answer.
Key proposals in the government’s white papersource British Medical JournalAll GPs to join a local commissioning consortium |
During 2011 an increasing wave of opposition to the proposals, a report of the Select Committee and the views of the Liberal Democrats, led Andrew Lansely and David Cameron to promise to "pause, listen and engage". A "NHS Future Forum" was appointed under Stephen Field to examine the proposals. Key issues were widening the membership of local commissioning bodies, its accountability; and the proposed role of Monitor as a body to encourage competition rather than cooperation and integration. After LibDem reversals at election in May 2011, opposition heightened on the risk that the Bill opened the way to competition which would make an integrated and comprehensive service difficult. The process was becoming messy and increasingly many in the service felt that Andrew Lansley, attempting major reorganisation at the time of financial crisis, was living in a parallel universe (la la land). In June 2011 the Prime Minister made pledges to involve doctors other than GPs and nurses in commissioning, and give Monitor a duty to promote integration. Greater competition would only be introduced when it benefits patient care and choice.
The Forum reported in June 2011 with "deep seated concern", making it clear that the Secretary of State was ultimately responsible for the NHS, that commissioning consortia should include hospital doctors and nurses, that they should have a board with meetings open to the public and stress should be placed upon providing an integrated service. The Forum also doubted whether the correct place for Public Health in England was within the Department of Health. Ministers responded in a Command Paper (CM 8113) accepting many of the suggestions. In an acrimonious debate the right suggested that easing back on competition made it harder to achieve efficiency, and the left that the earlier proposals had been ill-conceived. Alan Milburn, the reforming erstwhile Labour Secretary of State, saw the changes as unfortunate. The Times thought that the creation of clinical senates, health and wellbeing boards and other new machinery represented a victory for bureaucratic process and would slow change, rather than open the way to more efficient care.(Editorial 15th June 2011). Some 180 amendments were made to the Health and Social Care Bill, many being referred back to Parliament for reconsideration. The LibDems, having achieved many changes, asked for more. Doctors wrote to the media; the House of Lords debated the measure. The Future Forum remained in existence, considering education and training, public health, information and integration and the British Medical Journal outlined the main controversial issues such as privatisation, the role of Monitor and the responsibilities of the Secretary of State. Lansley wished to reduce the number of targets but improve outcomes, so indicators of outcome were introduced, a verbal rather than practical distinction.
By January 2012 medical and nursing professional organisations were implacably opposed to the NHS Bill, mainly because of the increased role competition would play, but also because of the turmoil engendered when management effort was needed to handle major financial problems. Changes in NHS pension schemes were also significant. "The upheaval had been unnecessary, poorly conceived, badly communicated, and a dangerous distraction at a time when the NHS was required to make unprecedented savings."
The previous Labour administration had been responsible for repeated changes in organisational structure. The Coalition was similarly active. The Times (20 January 2011) provided a diagram of the initial proposals. Progressive revisions increased the number of bureaucratic bodies. SHAs were clustered between October 2011 and April 2013, and PCTs were grouped similarly. In December 2010 Andrew Lansley appointed the Sir David Nicholson, Chief Executive of the NHS to the new post of Chief Executive of the NHS Commissioning Board. Moving from one role to another, Sir David would be able to ensure close alignment of policies.
A simple diagram derived from a Skills for Health External Briefing
The Guardian published a chart in August 2011 which showed a greater level of detail and complexity.
NHS Commissioning Board, Primary care trusts, Clinical commissioning groups, Foundation Trusts, Monitor,
While the Bill was the subject of a year's wrangling, radical reform was underway with rapid transition to clinician-led commissioning.
The relationships between the Department of Health and the NHS often changed and the White Paper proposed an independent and accountable NHS Commissioning Board. While the Secretary of State said the reforms would limit his power some thought this an abdication of responsibility and at the re-launch the duty to promote a comprehensive health service was restated including the maintenance a system for professional education and training . The establishment of the Commissioning Board reduced the role of the Department, which was slimmed down. Strategic Health Authorities would be phased out in April 2013 and were grouped into 4 clusters.
The Board would be sizeable with some 3,500 staff, taking on many of the functions of the Department of Health and the SHAs. It was established as a special health authority in October 2011 with Professor Malcolm Grant as its chair. It would design the new clinical commissioning system and have substantial powers over the commissioning consortia - including guidance and setting standards for their creation. The board would be able to hire and fire their accountable officers and have extensive leeway to bail consortia out. There would be tiers of management, including four sub national commissioning sectors, for London, the North (North West, North East and Yorkshire and the Humber), a South cluster of South Central, South West and South East Coast, and the Midlands cluster which would merge East and West Midlands and East of England. A more peripheral tier based on PCT clusters might be formed.. (Nicholson letter June 2011)
Mergers reduced the number of PCTs in England to 151 by 2010, mostly coterminous with local authorities. Overseen regionally by strategic health authorities, they were responsible for managing around 80 per cent of the NHS budget. They covered an average population of 340,000, but sizes ranged from 100,000 to 1.3 million.
Many PCTs rebranded themselves - City and Hackney PCT became "NHS City and Hackney". Doubts about their abilities as commissioners led to the introduction of "World Class Commissioning", with targets by which the trusts were judged. PCTs were told to divest themselves of community services and in roughly equal numbers these were merged or amalgamated with acute hospital trusts, mental health trusts or aspirant community foundation trusts.
The white paper, Equity and Excellence, liberating the NHS (2011) proposed PCT abolition initially by 2012. Andrew Lansley said: “We’ve been down the route of PCTs. I remember that whole process of fundholding moving to locality groups, turning to primary care groups, turning to primary care trusts....The process it has become more bureaucratic, more centralised and frankly less effective."
By early 2012 PCTs were wound down and clustered into 50 groups with a single management team. In London the 31 merged into the 6. Clusters of PCTs were seen as a peripheral arm of the future NHS Commissioning Board.
Several hundred consortia of general practitioners covering all England were envisaged to arrange for the provision of services and consult new Health and Wellbeing Boards in developing their services. They would be responsible for “the great majority” of NHS services for their patients. Budgets would be calculated on a practice-level and the new NHS commissioning board would have the final say in determining the membership and size of GP consortia. While PCTs had been responsible for all residents in a geographical area, CCGs would be responsible only for patients registered at practices within that group.
At the re-launch in June 2011 at least one nurse and one specialist doctor and at least two lay members (one with a role in championing public and patient involvement, and one overseeing governance, audit and remuneration) would be on the board which would meet in public and be supported by advisory clinical networks. They would have a duty to promote integrated health and social care around the needs of users. Ideally they would be coterminous with local authorities.
There were already examples; in Northamptonshire GPs in 76 practices with 650.000 patients had established a not-for-profit social enterprise company in 2007 to undertake practice based commissioning. It operated independently of the PCT as a GP led organisation with a substantial management structure. The country’s first GP commissioning consortium was launched in Cambridgeshire in October 2010 and was handed control of around a quarter of NHS Cambridgeshire’s £870m budget to decide commissioning except those covered by specialised commissioning arrangements. By 2012 257 'pathfinder' groups, early-adopters, covered 97% of the country generally with populations of 150-200,000, sometimes much larger. In many cases the consortia boundaries were those of the previous PCT. The National Commissioning Board would determine when the CCGs were ready to take on part or full commissioning and the extent to which they might need support and by April 2013 they would be fully authorised, or authorised with conditions, or remain as shadow CCGs in which case the NHS Commissioning Board or its local arms would commission on their behalf. The budget for management made groups with less than 100,000 population impracticable, and groups merged often creating one coterminous with a borough. CCGs would be able to turn to commissioning support units, descended from PCT clusters, particularly where equipment procurement and back office functions were concerned.
By May 2010, five years after the concept was launched, 130 Foundation trusts had been established, 46% of all acute trusts and 54% of mental health trusts. Monitor gave a diagram of the process and a map of their presence There remained 74 acute, 16 mental health, 11 ambulance and 16 community services trusts. Labour had set a deadline for the achievement of foundation status (2010) - missed - and the Coalition government confirmed the policy. William Moyes, the executive chairman of Monitor, felt that their performance had been impressive. A small élite were now exploring the full limits of their potential, with a handful aspiring to be truly world class. Foundation trusts had performed significantly better than other trusts in league tables though it could be argued that this was because they were the best managed already.
The Department thought achieving FT status was 'vital and urgent' but where this proved impossible the Department would break them up or force takeovers. Remaining NHS trusts signed an agreement (TFA) with the Department and their strategic health authority outlining the timeline and steps they would take to achieve FT status on their own, with an existing FT or in another organisational form. The NHS Trust Development Authority would be established in 2013, as a special health authority accountable to the Department, responsible for those unable to achieve foundation status, appointing their non-executive directors, managing their performance, and overseeing the pipeline towards FT status. The Bill set out details of failure regimes to ensure continuity of services. In 2012-13 the foundation trust pipeline had 45 trusts aiming to apply but in 2010-11 Monitor had received only 11 applications and approved only seven of them. Monitor stressed that “the bar would remain high”. Mid-Staffs prompted questions such as “How do we get comfortable about board capability and the strength of governance? Do we need more assurance from the CQC before we authorise?" The June 2011 revision of the Bill provided some breathing space; all NHS trusts would be expected to be authorised as FTs by April 2014 and “as soon as is clinically feasible”, with an agreed deadline for each trust. There would be no blanket deadline for the abolition of trusts as a legal entity. Monitor's stringent tests would remain, and while governors built their capability to hold their boards to account, the transitional period during which Monitor retained oversight powers would be extended to 2014.
Imperial was among trusts with massive financial difficulties and many non-FTs (such as the Royal London/Barts) had problems, big debts, mediocre management or poor services. In April 2011 the Department of Health listed 22 that would not meet the financial criteria for foundation status by the target dates. Most had major Private Finance Initiative problems and all trusts faced the difficulty of tariff reductions. The Department commissioned an assessment of whether the 22 needed national help, help at an SHA level, or whether local measures would suffice to solve the problem.(see Finance)
In financial year 2011/2 fifty trusts asked for at least £352m in “transitional support” and other assistance to help them meet regulator Monitor’s financial requirements for authorisation. The biggest demand, for £93.5m, came from a grouping of Barts and the London, Whipps Cross and Newham trusts. Andrew Lansley said applicant trusts would have to demonstrate their problem was: “exceptional and beyond those faced by other organisations”; “historic and that they have a clear plan to manage their resources in the future”; “that they were delivering high levels of annual productivity savings”; and that “they delivered clinically viable, high quality services - including delivering low waiting times and other performance measures”.The Health and Social Care Bill changed the title of the board of governors to the council of governors, and enabled any organisation specified in the in the constitution to appoint one or more governors which would help FTs strengthen their council. Boards would meet in public. Governors were given a duty to hold non-executives to account for the board’s performance and to represent the interests of FT members and the public. Governors could require one or more directors to attend a meeting to provide information on the directors’ performance of their duties, and annual reports must include information on any occasions where this power has been exercised. FTs would also have a duty to ensure that governors have the skills and knowledge to carry out their role. A failure regime would deal with FTs unable to meet their bills.
Hospital mergers were nothing new - as far back as the 19th Century they had been encouraged by the Prince of Wales' Fund (King's Fund). Done right, they were a valuable tool to drive better clinical and financial outcomes. But unlike the commercial field, health mergers were often politically mandated rather than organically initiated, and decisions that should have been taken before merger were approached during implementation. In May 2009 the East of England SHA had offered the first trust for merger or acquisition, the Bedfordshire and Luton Mental Health and Social Care Partnership trust. Trafford approached the Central Manchester FT. But the Heart of England FT had difficulty absorbing the Good Hope Hospital, and FTs were wary of the risks involved. What trust wished to jeopardise its reputation by taking on near insuperable financial problems? Easier was the combination with community services from PCTs, creating "vertical integration" of services. The level of debt made it important to consider staffing levels, as saving money on nurses might lead to poor patient care.
KPMG, in a global study, concluded that "due diligence" was often skimped in mergers enforced from the top which were less likely to succeed, timescales were often far longer than had been thought, differences in organisational culture were critical, and that mergers between weak organisations rarely worked. (Taking the Pulse, KPMG June 2011 & Times, 18 August 2011). Debt might have to be restructured and successful FTs should be incentivised to acquire others. Obtaining savings often took 3-5 years. A study by Bristol University (2011) showed that mergers were unlikely to be the most effective way of dealing with poorly performing NHS hospitals. The wave of hospital consolidation in the late 1990s and early 2000s – in which around half the acute hospitals in England were involved in a merger – brought few benefits. Poor financial performance typically continued, with hospitals that merged recording larger deficits post-merger than pre-merger. The length of time people had to wait for elective treatment rose after the mergers. There was also no increase in activity per staff member employed in merged hospitals, and few indications of improvements in clinical quality.
Sometimes trusts that had not obtained foundation status and had severe financial and managerial problems, considered merger as a solution. Mergers creating hospital giants seemed possible, for example
Barts, Whipps Cross and Newham Hospitals £1.1bn turnover
North Cumbria University Hospital + Newcastle University Hospitals + Cumbria Partnership £1.1bn
Imperial and West Middlesex University Hospital £1bn
North Bristol and University Hospitals Bristol £956m
In December 2011 the Commons public accounts committee questioned whether such reconfigurations would solve the difficulties of the worst performing trusts and predicted “some form of further intervention” would be needed. The committee said it was “already clear” that it would be “extremely difficult” for the remaining 113 non FT trusts to become foundation trusts by the government’s intended target date of April 2014. London was singled out for especial concern. "We remain to be convinced that combining struggling hospitals into larger trusts – as with South London – will somehow produce viable organisations offering good quality, accessible healthcare".
Monitor's traditional role had been to authorise foundation trusts, ensure compliance with their terms of authorization, and to aid "provider development" Lansley's plan was a change of role to 'protect and promote the interests of people who use health care services by promoting competition where appropriate, and through regulation where necessary'. In its new role Monitor would not be providing the existing level of support. There would be a special administration regime available for failing trusts. To simplify authorisation procedures, the Care Quality Commission and Monitor would integrate their requirements. Monitor would promote competition absorbing the current Competition Panel and guard against anti-competitive behaviour both by commissioners and providers and the Department would have powers to direct Monitor should the need arise. Where competition between providers was impracticable, as in the case of community and mental health services, competition might exist to provide the service, rather than to provide a second and competitive one. Monitor would continue to guarantee the provision of essential services if providers failed under a more competitive regime. (Times, 3 September 2010, p25).
Following the revision of proposals in June 2011 Monitor's core duty expanded tobecome a regulator for all NHS funded providors, not just FTs, regulating prices for NHS services and preventing anticompetitive behaviour against patients' inerestes.
Health and Wellbeing boards, new bodies to coordinate care, were to improve the coordination of commissioning across NHS, social care, and related children’s and public health services. They would have a role in authorising clinical commissioning groups. Their make-up was outlined in the Health Bill, the core membership was defined and the Department of Health left it to local authorities to decide how they are going to establish the boards. They would be public health oriented, developing their own statistical basis. Over a hundred "early implementers" explored how they might be structured and work together with the many providers and organisations whose cooperation was necessary.
The Panel was established in 2008 chaired by Lord Carter of Coles to consider potential breaches of the principles of co-operation and competition for example by looking at proposed mergers to ensure that a monopoly situation did not arise, and the way health services were promoted and advertised. Competition could be a spur to efficiency, but some rationalisation was often necessary. When primary care trusts were told to give up the management of community health services, the proposed mergers with other trusts were reviewed and proposals to merge trusts were examined to see whether alternatives existed within 30-40 minutes driving time.
When the NHS was established in 1948 Bevan established a Central Health Services Council to advise the Ministry of Health. Consisting of the great and the good, it met seldom though its subcommittees were influential. Later other high level strategic advisory committees were established, none of which persisted long. Following the final report of Lord Darzi’s Next Stage Review a new National Leadership Council was formed in 2009 to develop leadership across healthcare with a particular focus on standards, certification and the development of the right curricula and assurance). Following the change in administration in 2010 it underwent a "refresh exercise".
Liberating the NHS, Report of the Arms Length Bodies Review (DH, 2010) reviewed the functions of many bodies and the existence of some was confirmed, for example Monitor and the Care Quality Commission, others were scheduled for run-down. The Human Fertilisation and Embryology Authority and the Human Tissue Authority would have functions transferred and the Health Protection Agency and the National Treatment Agency would no longer be statutory bodies. Their functions would be transferred to health secretary and the new public health service would be established within the Department of Health, as Public Health England subsuming existing health improvement and protection bodies and their functions, Placing public health within a government department was challenged by the Field review and it was decided that Public Health England would be established as an executive agency of the Department of Health. It would be a distinct organisation headed by a chief executive with accountability for carrying out its functions.
annex B of the review provides a chart of the changes in arms length bodies and the changes
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Each year the Department of Health states the resources for the NHS and national priorities in the Operating Framework. Allocations were based on a complex formula involving population, needs, targets and the distance from targets. An Advisory Committee on Resource Allocation (ACRA) keeps the formula under review to ensure equal opportunity of access to health care for people at equal risk and to try to reduce health inequalities. As better population data becomes available these are incorporated (see 2010 letter). The proposal to move to consortia of GPs as commissioners made it appropriate to use GP registered populations, rather than PCT ones.
The 1991 market reforms were based on the purchaser-provider split. It was thought that, whereas in the past providers, usually hospital doctors, had largely determined what services would be provided, now commissioning bodies would act on behalf of patients to purchase the services which were really needed. Initially "purchasers" (health authorities and some family doctors) were given budgets to buy health care from "providers" (acute hospitals, and organisations providing care for people.) This split between purchaser and provider underwent several changes over the next 20 years but in essentials remained the same. It led to an increase in transaction costs, notably management and administration costs. Research commissioned by the DH but not published estimated these to be as high as 14% of total NHS costs. (See Parliamentary Committee 2010.) Commissioning was undertaken at different levels, dependant upon the scarcity of the condition. Specialised commissioning had long been required at national level and in 2007 a National Specialised Commissioning Group (NSCG), a National Commissioning Group (NCG) and 10 Specialised Commissioning Groups (SCGs) were formed. The complex arrangements were simplified in 2010 when NHS Specialised Services was supported by the Advisory Group for National Specialised Services (AGNSS). |  |
| Source: National Specialised Commissioning Group website |
Both Labour and the Conservatives looked at the tariff system for l savings. Tariffs had been based on average national costs; should they be based instead on the lower costs of the most cost-effective centres? Primary care trusts were allowed to link payments to local quality improvement goals by commissioning for "quality and innovation" A proportion of providers’ income would be conditional on quality and innovation, through the Commissioning for Quality and Innovation (CQUIN) payment framework.
Financial crisis was recurrent. The projected rise in the NHS budget in real terms from 2008/9 to 2010/11 had been 1.9% a year but as the 2008 financial crisis bit, and billions were poured into banks, projections were reduced to 1.2% between 2011/12 and 2013/14. Public debt would overhang services for ten years or more. The 2009 budget included large reductions in public service expenditure. In his Annual Report the NHS Chief Executive, David Nicholson, warned that “We need to move away from the NHS being built for growth to being able to sustain itself in a prolonged limitation on resources. We’ve had one or two years that were difficult. We’ve never had three or four years.” In 2009 four chief executives in the London area resigned for financial reasons within a week, including the Royal London and West Middlesex hospitals. Monitor saw the recession would slow the progress towards Foundation status.
A report for the Department of Health from McKinsey in March 2009 was leaked to Health Services Journal in September and ultimately published by the Conservative/LibDem government in June 2010 McKinsey implied that to achieve its planned £20bn savings by 2014 the NHS in England would need to slash its workforce by 10%, 137,000. The report revealed the brutal reality of the cost to the NHS of the collapse of the banking system. It recommended a range of “potential actions in the next six months” including a recruitment freeze, an immediate reduction in medical school places to avoid oversupply and an early programme to encourage older GPs and community nurses to make way for “new blood/talent". Acute services would take the brunt of the cuts. Some savings could come from clinical efficiencies, but not enough. Though all political parties had said that NHS finances would be protected, the report clearly had the Department of Health's support and had been shared with SHAs and senior management. When leaked, the Department did not question its accuracy, but attempted to disown the recommendations. Andy Burnham, the Secretary of State said “The McKinsey work… is not in any sense an NHS plan of action. They are just making some suggestions which will be looked at with many other ideas" Some calculations of the scale of cutbacks - over 50% of London acute hospital work - seemed completely infeasible. Some individual hospitals had historic difficulties in balancing their books and this put the quality of care in jeopardy. Over 5 years almost a billion pounds was spent keeping some 18 trusts afloat. One trust, Hinchingbrooke, a district general hospital in Cambridgeshire with a £40 million deficit, was offered by tender to private or NHS management. No NHS organisation would take on the risk and managerial effort. In November 2011 the the contract - the first to run an entire hospital - went to Circle Health, a John Lewis style partnership already running independent treatment centres.. | SummaryMcKinsey & Company ▪ The next spending review may well result in significantly lower rates of growth in NHS spending than has been the case for the last 8 years, resulting in a possible funding gap of £10-15bn in 2013/14 or ~ 10% of spend.▪ The NHS in England could potentially capture efficiencies in health and healthcare services by between 15 and 22% of current spend, or £13–20bn, over the next 3-5 years.▪ This reduction could come from– technical efficiency savings of £6.0 - 9.2bn found from provider costs – allocative efficiency savings of £4.7 - 6.6bn due to no longer commissioning low value added healthcare interventions and ensuring compliance with commissioners’ standards – savings of £2.7 - 4.1bn from a shift in the management of care away from hospitals towards more cost effective out-of-hospital alternatives. ▪ Further savings could come from a greater focus on prevention resulting in lower demand for healthcare services but this would likely not be realised within the next 3-5 years.▪ Achieving a step change in spend on health and healthcare services will require a compelling case for change; the use of formal mechanisms to drive through efficiency gains; deployment of WCC structures and processes; removal of national barriers to change; introduction of incentives schemes; and an increase in skills and capabilities to drive out costs.▪ We recommend a nationally-enabled programme delivered through the SHAs and PCTs to drive through efficiency savings. The DH should take direct actions to capture some opportunities e.g. lowering tariffs. And should enable delivery by creating a compelling story, removing barriers, developing frameworks/tools and embedding the drive for efficiency gains within existing mechanisms e.g. WCC. |
Some believed, without much evidence, that massive savings could be achieved by the transfer of care from hospital into the community, polyclinics or federated practices. The Department of Health made small sums available to support the Transforming Community Services (TCS) programme. The operating framework for 2010 required a 30% reduction in management costs in PCTs and SHAs, and acute trusts would be paid only 30% of tariff costs above the agreed activity level of the previous years. Tariffs would not be increased for inflation. Gloucestershire Hospitals FT needed to make savings of between £27m and £30m and as part of wide ranging measures it considered a phased plan to close 150-200 beds A health minister, Mr O’Brien told parliament in March 2010 that blaming the economic situation for the cuts was “nonsense”. A manager wrote that "Ministers say you must save £20 billion. Ministers then get upset when the NHS puts forward plans to save £20 billion because it involves shutting beds and reducing staff numbers. How else does one save substantial sums of money in a labour intensive industry? We could of course keep all the beds open and just cut staff -but only if they want a Mid Staffs to pop up every other week."
The King's Fund and the Institute for Fiscal Studies produced an analysis, How cold will it be? in July 2009. For 20 years Jack Wennburg, in the USA, had suggested that reduction in the variations in service provision would save money - though there was little sign of major success in altering the differences even in his home states. The Dartmouth Health Atlas identified conditions where the rate of surgery differed greatly. If there was a £20 billion shortfall, in a labour intensive service what was the answer? The BMJ published a special issue on 20 March 2010 on savings that could be made without harming services. A pay-freeze for consultants, GPs and senior managers was imposed in 2010. | Ten Common Conditions with Widely Varying Use of Discretionary Surgery • Early Stage Cancer of the Prostate An Agenda for Change |
The proposed North Tees Hospital was cancelled. In June 2010 the Government appointed an Independent Challenge Group (ICG) of civil service leaders and external experts, to examine the spending review process. In September the group warned that NHS savings might not be achievable and Government might face either a growth in waiting times or the need to inject billions more into the NHS. Following the Spending Review in October 2010 it was announced that the NHS budget would rise in real terms by 0.1%, keeping the promise to protect the NHS budget, (just). Several billion pounds under spending from previous years would be lost to the NHS. PCTs needed to reduce their spending and increasingly began to impose control on the elective admissions for which they would pay. Lancashire PCTs reviewed more than 70 procedures including the usual cosmetic ones, such as baldness, tattoo removal and breast augmentation, including after mastectomy. Some were more about life choices than improving health, such as IVF and reversal of sterilisation and vasectomy. And more controversially, endoscopic procedures of the knee joint, lumbar spine procedures for back pain, removal of breast implants breast reduction to relieve symptoms, and removal of anal skin tags.(Health Service Journal 16 November 2010) If the starting point was evidence that something worked safely and provided value for money for society and the individual, where did that leave complimentary medicine? The UK's only professor of complementary medicine wrote that some within that field were ready to resort to intimidation and legal action in a way that was downright scary.
The tariff for 2011/12 was cut by 1.5% and there was no longer money to reduce waiting lists, indeed lists might have to be "pushed out" to save money - PCTs sometimes imposed minimum waiting list times - rather than maximum. Most acute trusts saw their budgets fall by 7-9% and many predicted the loss of a substantial number of posts. Whipps Cross in east London, facing a £4.5m deficit, needed to take "extraordinary financial measures". The hospital urged staff to "sacrifice" some of their annual leave or do unpaid work to save money. Consultants were asked to do extra clinical sessions. (BBC 6.10.2011) The tariff price for NHS services was cut again, by another 1.5%, in 2012/13 to drive increased efficiency.
To have any chance of staying within budgets, significant reconfiguration was needed. In London more than half a dozen hospitals, such as Chase Farm needed to change moving from an acute role to elective work, often with the closure of A and E. However, the temporary embargo placed on reconfiguration by Andrew Lansley, political pressure from MPs and public objections made change near impossible. The trusts with the greatest financial problems were often those most at risk of poor clinical performance. (The Times 17 June 2011). The Department accepted that hospitals with large PFI debts might never repay them. and in October 2011 the government has identified 20 trusts whose “clinical and financial stability was at risk” because of “cash-flow shortages” and legacy debt. Andrew Lansley said trusts in question had told the Department of Health they would “need help to become sustainable for the long term”. Trusts facing high PFI repayments might need bail-outs. Indeed the Barts and the London trust were seeking £22 million annually to manage their PFI debt. McKinseys assessed which trusts would need support to enable them to reach foundation trust status; NHS London believed that only a third (6) of its acute non foundation trusts were financially viable even after major efficiency programmes, and in February 2012 the Department of Health placed the cost of bailing out seven trusts with PFI problems at 1.6 billion pounds - St Helens and Knowsley, North Cumbria, Dartford & Gravesham, South London Healthcare Trust, Barking, Havering & Redbridge and Maidstone & Tunbridge Wells.
The 13th Report of the Parliamentary Health Committee in January 2012 said that fundamental change was necessary to save the sums on money envisaged, £20 billion. Long term restructuring of services, closer coordination of health and social services rather than short term savings, was required. The distraction of a major reorganisation did not help.Hospital standardised mortalities and patient reported outcomes
Healthcare Commission & Care Quality Commission
Council for Healthcare Regulatory Excellence
National Institute for Clinical Excellence
Quality was now high not only on clinicians' agenda but on that of the NHS organisation. Lord Darzi said in 2008 in High Care Quality for All, that "Quality will be the organizing principle of the NHS." The final Darzi report in 2008 also placed emphasised quality as "at the heart of everything we do". Following the Next Stage Review healthcare providers had to publish ‘Quality Accounts’ just like financial accounts. A standard form of account was set out but analysing a sample of the reports for 2009/10 the King's Fund said they were extremely varied in choice of measures, the presentation, variation in coding quality, participation in national clinical audits & confidential enquiries and the extent of local involvement.. It was not possible to assess quality of care of providers from the quality accounts. The aims of quality accounts and the intended audience were vague - the Fund thought the audience ought to be the general public. The fundamental tension at the heart of quality accounts was between requiring content that enabled comparability between trusts, and allowing providers local flexibility in the information chosen. | Required content of quality accounts in 2010Quality accounts should include: · a statement from the chief executive · priorities for quality improvement and why they have been chosen · a review of the quality of services, using selected quality indicators chosen by the provider but aiming to be representative of quality across all the services provided · a standardised set of statements on data quality, participation in clinical audits and confidential enquiries, participation in research, Commissioning for Quality and Innovation (CQUIN) schemes and Care Quality Commission assessments · a description of who has been involved and engaged to determine the content and priorities · external comments provided by the lead commissioning primary care trust (PCT) and the LINk and HOSC, if they choose to provide it, to ensure that there is some external assurance and scrutiny of the content. |
For over twenty years organisations had wrestled with the problem of "how to contract for quality". The introduction of tariff payments was partly based on the view that if all providers charged the same, those "purchasing" services would do so on the basis of quality. On the principle that if you cannot measure something, its existence is questionable, a new industry developed in "metrics" - what was quality, how did one recognise it and how was it measured? Structure, process and outcome had long been recognised as facets of quality, now effectiveness, safety and patient experience were seen as groupings for assessment.
Over 60 organisations in the UK had some claim to inspection or regulation and continuous improvement of quality of health care was an international movement. In 2008 a National Quality Board was established for the NHS. Very much a body of the great and the good, it brought together the Department of Health, the Care Quality Commission, Monitor, NICE and expert and lay members from Royal Colleges and consumer organisations so the many regulators came together in one room. Its aim was to bring together senior people interested in improving quality, to align and agree the NHS quality goals, whilst respecting the independent status of participating organisations. At a more local level, the Department of Health’s first publication on quality for 2009-10 designated 24 hospital and four ambulance trusts as having their “performance under review”.
As part of the review of Arms Length Bodies, the four Confidential Enquiries were examined and their structure, approach and management reviewed. From September 2011, the Healthcare Quality Improvement Programme (HQIP) became responsible for their management and commissioning, previously the responsibility of the National Patient Safety Agency (NPSA). HQIP was established in April 2008 to promote quality in healthcare and iincrease the impact that clinical audit had on healthcare quality. It was led by a consortium of the Academy of Medical Royal Colleges, the Royal College of Nursing and National Voices (formerly the Long-term Conditions Alliance).
The US remained in the lead in quality developments. Its Joint Commission introduced patient reports on the safety of care and examined patient care pathways, alongside its 50 year old accreditation programme. Its annual report showed steady improvements. The expansion of clinical knowledge made it essential not only to work in teams, but to accept that medicine's complexity had overwhelmed the ability of individuals to manage it, however expert and specialised. As a result, basic steps were missed and patients died. In aviation, simple pre-flight check lists had saved many planes. The introduction of a surgical check list in 8 hospitals world-wide showed a reduction of death rate from 1.5% before the checklist was introduced to 0.8% afterwards. 19 checks before anaesthesia, before skin incision and before the patient left theatre showed that gaps in teamwork and safety practices were substantial in countries both rich and poor.
Don Berwick said "you need policemen even in heaven". That existing mechanisms could not be relied upon was demonstrated at Mid Staffordshire Foundation Trust. In March 2009 the Health Care Commission published a swingeing report into substandard care at the trust which, having a large financial deficit had new management and had corrected this in part by staff reductions, including nursing. The financial problems were solved but at the cost of a failure to address quality which had been a longstanding issue. Mortality data from Dr Foster had suggested problems subsequently confirmed. That foundation status had been granted in 2008 when problems were already being investigated, made clear the lack of communication between Monitor, the SHA and the Healthcare Commission. The regulatory organisations blamed each other. Theoretically, because of excess mortality at the hospitals, as many as 400 people might have died over a period of years when there had been "appalling" emergency care in understaffed departments inadequately skilled, with deficiencies in ward staffing, equipment and management. Professor Sir George Alberti, national clinical director for urgent and emergency care, began a review of the trust's accident and emergency services and in July 2009 the Secretary of State (Andy Burnham) asked Robert Francis QC
to investigate any individual case relating to the care that ... causes concern and to the extent that it considers appropriate;
to consider what additional action is necessary for the new hospital management..
Robert Francis' report, The Mid Staffordshire NHS Foundation Trust Inquiry, (February 2010) said the board showed a lack of urgency and relied on data systems rather than patient experience. The Board tended to restrict itself to strategic issues and had too little contact with operational matters. The overwhelming problems seemed to be the provision of basic nursing care. "The experience of listening to so many accounts of bad care, denials of dignity and unnecessary suffering made an impact of an entirely different order to that made by reading written accounts." Targets seemed to come before quality, and compassionate care was often lacking. There was a reluctance by staff at all levels to persist in raising concerns. The report contained three key recommendations, accepted by the government -
A further public enquiry was established in 2010 by Mr Francis who would look at what went wrong at outside organisations, regulators and strategic authorities, which allowed the situation to develop. Daily, the evidence of senior figures appeared on the enquiry website.
Four patients died at Stepping Hill Hospital, near Stockport, in 2011 and 11 patients survived the effects of deliberate contamination of saline solution. Insulin was found in a batch of 36 saline ampoules in a storeroom close to ward A1 of the hospital
For 40 years workers in the USA led by Jack Wennberg had found major differences in the provision and usage of services such as hysterectomy and prostate surgery often unrelated to population need. In 'effective care' the benefits outweigh the risks and the right rate of treatment is 100%. In 'preference sensitive care' there is more than one generally accepted treatment, informed patient choice is called for, but rates vary extensively because of differences in professional opinion. 'Supply sensitive care' depends more on the capacity of local facilities than on clinical need. [see Wennberg article] The Dartmouth Health Atlas had showed conditions where the rate of surgery differed greatly. The idea of an atlas was taken up in England in 2010, overseen by Sir Muir Gray and Philip DaSilva, who acknowledged the 'inspirational publication' of Wennberg's atlas (1998), and his vision in first charting this territory. There were many US sound-bites - "doing the right things and doing things right."
The English version was created within the Department of Health's quality, innovation, productivity and prevention programme (QIPP). The NHS Atlas of Variation in Healthcare showed dramatic differences in wellbeing, health outcomes, spending and service provision across England, much inexplicable by health need. Some variations highlighted shortcomings in the quality and value of services for under provision can be as much a problem as overprovision.. A function of the atlas was to encourage commissioners to look at the unwarranted variations some of which seemed examples of Julian Tudor Hart's "inverse care law" - the greater the need, the poorer the access. Thirty four maps covered different conditions, for example asthma, diabetic amputation and asthma. There was a more than a 10-fold variation in the proportion of high risk transient ischaemic attack cases treated within 24 hours.
Standardised hospital mortality ratios (HSMRs), published on the NHS website, were only a blunt indicator of quality. A concept developed earlier in the USA, the indicators had critics but were welcomed by patient organisations. The UK HMSR was derived from Jarman's work with Dr Foster, an independent organisation, collecting data from hospitals on a voluntary basis, (see chapter 6). It was a statistical calculation that measured the overall rate of deaths within a hospital or trust, it compared it with a national average. However the HSMR focused on the medical conditions associated with 80% - not all - of deaths in hospitals. It did not adjust for the many patients admitted specifically to provide care near the end of life. HSMRs were increasingly criticised because of variations in coding practice and the extent to which multiple morbidities, which increased death rates, might or might not be coded. Unjust criticism of a hospital could destroy morale and create inappropriate criticisms. Some findings were of great interest, for example Dr Foster showed that mortality rose slightly in the first week of August when new doctors took up their posts; a similar effect was seen in the USA in July when the same thing happened. As the national mortality rates fell, individual hospitals that had improved but less than their peers, found that their rates were higher. It was said that if HSMRs had not been used to make heroes or villains, they were perhaps one of the best measures we had. Dr Foster's annual hospital guide in 2009 gave hospitals a safety index, and while it was to be expected that hospitals low on the list would challenge the methodology, some criticism came from eminent independent statisticians and public health physicians. Media comment, including The Times, made Dr Foster's data a matter of public interest. | Mortality rates: a history
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The DH and regulators became engulfed in the row because the ratings contradicted trusts’ performance. Sometimes a low rate was associated with clear clinical shortcomings. Sometimes it was not. There was an increasing number of organisations in the quality assessment field and after a tendering process in 2010 during which 8 organisations submitted bids, the contract to provide HSMRs passed to IMS, "a premier source of global pharmaceutical marketing intelligence".
To resolve the concern that different systems produced different results assessments, the NHS medical director Sir Bruce Keogh established a group to agree a method for calculating hospital mortalities. The indicators would be standard, open and published by the NHS Information Centre, to ensure parity of use and interpretation by all including the public. In the US the National Quality Forum was also seeking measures of hospital quality, by specialty and overall. A Massachusetts study compared the results from four different, commercial, hospital-wide mortality "products" including Dr Foster. They were all presented with exactly the same state database. The results from the four vendors differed markedly, and in some cases hospitals identified as above average performers by one commercial product were classified as below average by others, and visa versa. The study concluded that “without clear consensus on a methodology, public release of hospital mortality results can potentially create patient distrust and confusion among consumers”.
Mounting evidence that outcomes were poorer at the weekend led to calls for hospitals to move to seven day working and consultant cover.
Since 2009 providers had to collect patient competed summaries, health status and quality of life information before and after hip and knee replacements, varicose vein and inguinal hernia surgery. The first results were published in September 2010 by the Information Centre and showed that those undergoing joint surgery experienced improvement in 80-90% of occasions, varicose vein and hernia surgery patients showing less improvement.
In October 2008 the Commission published its third and last health check assessment. Annual improvement was evident, there was roughly a 10 percentage point increase in both the proportion of trusts scoring excellent for quality of services, and the proportion of trusts scoring excellent for use of resources.
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Waiting times for cancer treatment, a significant problem for the NHS, had come down. Ambulances were responding faster. MRSA rates were falling, though not all trusts were improving as they should. Problems remained in primary care, such as access to GPs and the provision of choice. Regionally, performance in most areas had improved, less so in London. Sir Ian Kennedy, in a letter to staff, regretted that relationships between the Commission and the Department of Health had been fraught. "Given the highly politicised nature of any discussion of the NHS, government both saw the need for the regulator and at the same time felt uncomfortable about it, particularly when it brought bad news." Sir Ian said. "Regulation was sometimes seen as part of the problem rather than part of the solution". At the end of its existence (2004-2009) the Commission produced a legacy report. It believed that it had played an important part in the improvement of quality of care, a view shared by the majority of trusts that thought that the annual health checks had improved quality. Investigations into serious failings had improved safety. The handover from the Healthcare Commission to the Care Quality Commission was not smooth.
The Care Quality Commission was established in April 2009, merging the Healthcare Commission, the Commission for Social Care Inspection and the Mental Health Act Commission. Baroness (Barbara) Young, the Chair, resigned within a year. The CQC had enforcement powers and could close an organisation which the Healthcare Commission could not directly do so. Outcomes would be a major focus. There would be "periodic reviews" of commissioners and providers. As it united health and social services, assessment of local authorities and primary care trusts would be aligned. Six groups of issues would be assessed, involvement and information
The CQC would look at boundary issues and problems, how health and social care worked together, and at care pathways The CQC used information from a variety of sources (declarations, audit, views of patients and staff and its own inspection programmes) to provide rolling quality and risk profiling to identify which providers it needed attention and hopefully to involve service users in the course of inspection. It was sponsored by, paid for by and accountable to the Department of Health, though some money came from those regulated. The fines it could levy were comparatively small and were there to attract attention and achieve publicity and embarrassment rather than as punishment in financial terms. The Commission wanted to encourage good practice, not merely discourage bad practice. There were dozens of bodies and organisations also involved in quality, and the CQC wished to work with them, and not create duplication. A new body, the National Quality Board, was created in the hope that some alignment of all these organisations could be achieved.
The 2009 hospital assessments, based on the CQC system, showed a number of trusts' performance to be poor. A spot check at Basildon and Thurrock showed major problems of hygiene and higher than expected death rates. There were concerns about the Colchester Foundation Trust whose chairman was summarily removed by Monitor.The Department asked the CQC to check all trusts for problems and the CQC chair, Barbara Young, retired unexpectedly. She seemed to have lost confidence in the government’s health check approach to assessing hospital performance and perhaps wanted a greater ability to influence matters. The complexity, overlapping contributions and arguments both academic and political about how inspection, regulation and assessment should work, made the whole issue too hot to handle effectively.
The CQC registered all 338 trusts, but made 21 subject to conditions for inadequate infection control. In its first assessments in October 2009 the CQC raised concerns about the 20 trusts rated “weak” on Quality and a further 27 that had not been higher than “fair” for Quality and Financial Management in the last four years and which faced a tough challenge to meet requirements of the new registration system. It was "clear that many have significant work to do to and a short time in which to do it. From January 2010, all trusts in England, were legally bound to be registered with the Commission and from 2011 this included NHS primary care providers, including GPs and dentists, who had not previously been subject to regulation by the Healthcare Commission. The sheer number of providers of health and social care made this a massive undertaking, not least because the CQC budget fell by a third. (King's Fund Brief on regulation) As full registrations were issued, Mid Staffordshire NHS Foundation Trust and Milton Keynes Hospital NHS Foundation Trust were told their registration with the Commission was conditional on them improving the safety and quality of their care and maternity services, and a further ten trusts were given only conditional registration shortly after.
The White Paper, Equity and Excellence, removed the role of inspecting 'commissioners' to focus solely on the safety and quality of providers. Working with Monitor, it would operate a joint licensing regime. It would host the central component of HealthWatch - an "independent consumer champion." A new Chair, Dame Jo Williams, previously of MENCAP, was appointed to carry the work forward.
The Commission had problems - its role was wider and its staff fewer. It did not have the staff for frequent inspections and was found wanting at Winterbourne View, a private hostel providing for 24 residents with severe learning disabilities. It did not react to information from a whistle blower about serious abuse until a Panorama programme in 2011 led to arrests and a Ministerial call for a report into the performance of the CQC and local authorities. The abuses were reminiscent of the scandals in the much larger hospitals of the 1970s. In response a programme of spot checks began. In its report (October 2011) of the findings of 100 unannounced inspections of NHS acute hospitals between March and June, which looked at whether the essential standards of dignity and nutrition were being met on wards caring for older people, the CQC found around half of the hospitals needed to do more to ensure that they were meeting people’s needs – with twenty of the hospitals visited failing to meet essential standards required by law. Shocking examples of bad care were exposed and the CQC called for a system-wide response to combat the failings. The CQC came under attack from the National Audit Office for failure to give value for money, concentration on registration procedures and reducing the number of inspections, undermining patient safety.
Council for Healthcare Regulatory Excellence
The Council for Healthcare Regulatory Excellence (CHRE) is the overarching, independent body overseeing the regulatory work of nine regulatory bodies
The Royal Pharmaceutical Society of
In 2009 the General Medial Council introduced the license to practice, required for all practicing UK doctors in addition to their registration. Licensing was the first step towards the introduction of revalidation to give patients assurance that doctors were up to date and fit to practise. Revalidation was likely to include appraisals, assessments and specialty standards. The Department of Health’s Arm’s Length Bodies review decided that CHRE was to continue and its role was to be reformed and extended to include quality assurance of voluntary registers.
In 2009 NICE reached ten years of age. Controversial from the outset, survival alone was something to celebrate. It remained under challenge. The threshold for deciding which drugs were cost-effective enough to use was arbitrary, was it too low or too high? NICE did not stop the use of less cost-effective interventions already in use. How should drugs be handled when companies chose to submit no evidence? In the absence of an inquiry by NICE they continued to be used. Its unpopularity with the drugs industry was contrasted with its popularity with governments around the world.
Decisions might be revised as in the approval of ranibizumab (Lucentis) for age-related wet macular degeneration. Sometimes patients wishing to receive life aiding drugs found that they were denied them by NICE guidance. When with the support of their doctors they tried to purchase them they were sometimes denied NHS treatment as government did not wish to see a difference between those who could pay, and those who could not. Public outcry at the refusal to let people spend their own money on their health led to the commissioning of a review. In 2008 draft guidance by NICE that four drugs, which could prolong life but not cure, should be denied on cost effectiveness grounds rarer cancers was criticised by oncologists who felt that any restriction of prescribing on the grounds of cost was reprehensible and the Conservative opposition agreed. Other commentators believed that there had to be some limit to the costs the NHS was expected to pick up. In fact of 102 uses of drugs for cancer, examined by NICE between 2002-2010, 73% were approved. Of 372 assessments of all drugs, 83% were accepted. (Financial Times 11 October 2010)
The Chair of NICE, Sir Michael Rawlins, wrote "It really is time that some of my clinical colleagues woke up to the realities confronting all healthcare systems. An ageing society, technological advances and public expectations are placing demands that all countries are struggling to meet. Countries do not have infinite sums of money to spend on health and the amount they can afford is largely governed by their wealth as reflected by their gross domestic products. The debate is not about whether - but how - healthcare budgets can be most fairly shared out among a country's citizenry."(HSJ 18 August 2008) He thought that the prices charged by drug companies were excessive - so others - in support of the pharmaceutical industry - replied with some justification that only an industry with the profit incentive would produce new drugs, quoting the steadily appearance of drugs for AIDS.
NICE was caught, inevitably, in a media storm. Firm implementation of national guidelines might ensure a consistent deal for patients across England, if not in Scotland, Wales and Northern Ireland. But the consistency might be refusal for, as NICE had to take account of all who depend on the NHS (not just patients suitable for treatment by the drugs it considered).
One issue was the time it took before NICE published its assessments. The Labour government proposed a faster system for referring drugs and healthcare technologies to NICE, a new NICE committee to increase its capacity to assess new drugs, more "horizon scanning" to help identify new drugs and issues early; and guidance for PCTs on how to deal with requests for drugs not yet assessed by NICE. In 2010 the Conservative/LibDem coalition proposed a special £200 million fund to pay for significant but expensive cancer drugs. Andrew Lansley said ."It is unacceptable that we should be one of the leading countries in western Europe for cancer research ... yet sometimes it’s our patients .. who find that they don’t have access to the latest new cancer medicines.”.
In 2009 NICE was commissioned by the Department of Health to manage the process of developing independent quality standards, a consistent set of measures which might be used in commissioning and inspection. Topics were selected by the National Quality Board that had been created in 2009, which submitted its final report in July 2010, and NICE worked with other organisations and to test the quality standards. The first of 150 standards dealt with the quality of care in stroke, venous embolism and dementia. For example it said that patients who had had a stroke should be offered at least 45 minutes of active therapy five days a week.
NICE expanded into a new field, nutrition. It recommended that to reduce deaths from cardiovascular disease, sugar, salt and trans fats should be phased out of food in 2010. It was also discouraged from pursuing some work in the public health sector.
A new system to encourage patient participation, LINks, was introduced in 2008. Each local LINk related to a matching local authority that provided social services, the LINk covering both health and social services. It was a network of local individuals, groups and organisations covering all aspects of publicly-funded health and social care .Built on existing networks & community activity it was independently funded and supported by a ‘Host’ organisation (appointed by the local authority. LINks had the right to be consulted about services and, in many instances, to enter premises and inspect services. Where they had concerns, they could ask organisations to respond to their anxieties. The establishment of these new organisations was halting LINks varied widely in their attitudes, some believing in cooperative working with local trusts, others being intrusive and run by people with long standing grievances, special interests, or political views, often critical of the NHS in general and their local services in particular.
The White Paper Equity and Excellence, liberating the NHS proposed that within the Care Quality Commission there would be a new independent consumer champion, HealthWatch England, to which LINKs would relate as local branches. Local groups would be funded by and accountable to local authorities. They might be commissioned to provide advocacy and support, and help individuals who wanted to make a complaint. They would support people who lacked the means or capacity to make choices, for example of a general practitioner.
In the 1950s Professor Sir Max Rosenheim, at UCH, laughingly defined a fit person as one who had been inadequately investigated. Fifty years later long standing concern about "medicalisation" led to worry that the definition of common conditions had been broadened so much that the entire elderly population had at least one chronic disease. The diagnosis of pre-hypertension, irritable bowel syndrome, ADHD, bipolar disorder, gestational diabetes and other conditions was widened so people with mild problems at modest risk were exposed to the harms and costs of treatment of little or no benefit. New diagnoses were as dangerous as new drugs. Often members of panels considering the definition of disease had significant links with the pharmaceutical industry. Experts tended to loath the idea of missing a potential patient and in the US, the FDA discouraged doctors with major financial conflicts from taking part in advisory panels on the approval of drugs.
Diagnostic technology was forever improving. The miniaturisation of electronics, seen for example in the ever more sophisticated mobile phones, began to find clinical applications. Newly developed, a 'Band-Aid' patch could transmit ECGs, oxygen saturation and pulse to monitors without complex equipment.
The framework for the provision of clinical services was increasingly set on a national basis by clinical strategies proposed by the National Clinical Directors, discussed locally within the framework of service commissioning, and associated with re-configuration of local hospital services. Quality became the touchstone as services such as those for trauma and stroke were planned on a regional or sector basis.
The goal of the WHO declaration in 1978 on Healthcare for All, with its accent on primary health care, was not achieved. In 2008 a new report appeared from the same city, Alma Ata now known as Almaty, Now more than ever. The evidence was robust that better outcomes for the population at lower cost were achieved in systems that distributed resources according to health care needs, eliminated co-payments, assumed responsibility for funding and provided a broad range of services within primary care. The goals of 1978 had not been achieved, but now at least more was known about how to handle the challenges. The election of President Obama in 2010 led to a review of the US contribution to global health aid, with a new accent on outcomes, particularly as far as maternal and child mortality was concerned.
Alan Johnson, as Secretary of State, made the narrowing of 'health inequalities' a priority for the NHS, attending the launch of Health Inequalities; progress and next steps (June 2008) supported by Sir Michael Marmot, he made clear his commitment. He described the drop in life expectancy by one year at every tube station going east on the Jubilee line from Westminster to Canning Town. While the health of the poorest had improved significantly, the health gap remained. National targets were set to reduce inequalities in health outcomes by 10 per cent as measured by infant mortality and life expectancy at birth by 2010. There would be restriction of TV advertising before 9 p.m. of high calorie junk foods and provision within primary care health of education on lifestyle. Reliance was sometimes placed on self-regulation by industry. PCTs in the more deprived areas would receive extra money to pilot such initiatives as health trainers (local people advising others on healthy living).
In February 2009 the Parliamentary Health Committee reported that while health in the UK was improving, over the last ten years health inequalities between the social classes had widened - by 4% amongst men and by 11% amongst women. The NHS atlas of variations in health care illustrated the changes in life-expectancy graphically.
The Marmot ReportA review of health inequalities was announced in November 2008 by the Prime Minister at an international health inequalities conference and commissioned from Professor Sir Michael Marmot to help government's health inequalities strategies and set objectives for future action in England. Examining existing work (including that from groups chaired by Sir Michael and WHO information) e.g. Tackling Health Inequalities: 10 Years On (DH, 2009). Fair Society, Healthy Lives was published in February 2010 and was an analysis of health inequalities in England. The review advocated the improvement of health and well being for all and the reduction of health inequalities. It wanted a focus on the early years of life, (early child development programmes, safe neighbourhoods, decent housing) social justice, health and sustainability to be at the centre of public policy for all major aspects of society were key determinants of health, not just the health services. The Guardian said 'The Marmot report has made it clear – for better social wellbeing we must slash disparities in education, income and health.' Nevertheless life expectancy in England was at record levels and the disparity across social groups was narrowing. | Six policy recommendations to reduce health inequalities
Source : BMJ 2010;340:c684 13 February 2010 |
The Coalition White Paper, published in November 2010, a response to the Marmot Report, contained few surprises but was welcomed by Marmot. A new public health service would be established within the Department of Health, at its centre the Health Protection Agency. Public health responsibilities would be transferred to local government from April 2013, with ring-fenced budgets probably of the order of £4 billion, and a Director of Public Health accountable to the local authority and advising on commissioning. Detailed documents on major hazards such as obesity would follow on tackling causes of premature death and illness and reducing health inequalities. The Department set targets for the reduction of deaths in the major groups such as cancer, circulatory diseases, suicide and undetermined injury, and accidents. Throughout the developed world death rates were falling, and in most cases they were doing so in England.
Sir Michael was appointed as director of a new UCL Institute of Health Equity, established with Departmental funding in 2011 that aimed to reduce health inequalities through action on the social determinants
The geographical pattern of mortality in
A "Mediterranean diet" had consistently been shown to be associated with longevity. The dominant components seemed to be moderate consumption of alcohol, low meat consumption, and a high consumption of vegetables, fruit, nuts olive oil and legumes. Faced with the 'epidemic of obesity' and pressing to reduce health inequalities, the use of financial incentives to achieve healthy behaviour was high on the agenda. Disincentives in the form of alcohol and tobacco tax were known to affect behaviour. The effect of positive incentives was less clear cut. In 2009 government launched Change4Life, a 'society-wide movement' aiming to prevent people from becoming overweight by encouraging them to make changes to their diet and levels of activity. Other campaigns related to lowering alcohol consumption, and the use of sun beds by those under 18 in the light of the rising number of cases of skin cancer.
Alcohol misuse posed a huge clinical and public health problem throughout Europe. Those who had campaigned against smoking had a new target. In the UK alcohol consumption had risen at the same time as its costs, in real terms, had steadily fallen. In 2009 England's CMO, Liam Donaldson, had called for a minimum price for alcohol. The BMA, the Royal College of Physicians, and the Faculty of Public Health added their voices to the demand, believing that the serious effects on health and society could best be mitigated through legislation on price and marketing. In 2010 NICE also argued for a minimum price per unit of alcohol to reduce consumption.
Drug therapy was converting fatal diseases into chronic ones, to be controlled if not cured. A new chapter was opening for medicine, cancer probably being in the lead although other specialties were following. Though many drugs had emerged before the molecular basis of their activity was understood, unless that was known they might be used inappropriately - for example only a quarter of patients with breast cancer benefitted from Herceptin. Drugs that hit a particular DNA segment might, in fact, be usable in several diseases. If the money spent on drugs was to be made to count, better diagnostic systems were needed (although there were few financial incentives for their development.) Biological markers of effectiveness were required, molecular level signatures of response, so that treatment could be personalised and money was not wasted on people who were not benefiting. If non-responders could be identified, some of the rising costs could be avoided.
The development rate of new drugs slowed. To assist this, and to make the country a more attractive base for the pharmaceutical industry, it was decided to open up the fantastic research resource of the NHS so that anonymised data could be used..
People were increasingly given greater access to medicines, sometimes by increasing the range of trained professionals allowed to prescribe (nurses, pharmacists), by allowing people who met specific criteria to obtain certain medicines automatically, or by making prescription drugs available over he counter if considered safe. Some 60 had recently been reclassified from prescription only to pharmacy only, for example simvastatin, (statin), griseofulvin (antifungal) and hydrocortisone and nystatin ointment. Professionals were particularly concerned when antibiotics were proposed for reclassification because of fears of growing antibiotic resistance.
The right to write prescriptions - once the doctor's prerogative, had been extended over ten years, particularly to nurses. Out of 690,000 nurses in 2009, 40,000 could prescribe, the majority in general practice. The process had gone smoothly, nurses being cautions, many having "supplementary" rights (prescribing within a care management plan agreed in advance with a doctor. "Independent" prescribers could prescribe any medicine for any condition that fell within their area of competence. Where nurses were leading, other professions were following, for example pharmacists.
The drug treatment of obesity had not lived up to its promise - two of the three drugs released earlier were withdrawn because of clinical trial data pointing to an increased risk for stroke and heart attack. Roughly 100,000 people in the United States were taking sibutramine at the time.. Perhaps we should just learn to live with obesity and its hazards, or aim for surgery. The diabetes drug rosiglitazone (Avandia) for type 2 diabetes had been licensed 10 years before and lowered glycated haemoglobin. Controlling blood sugar was assumed to mean that the vascular complications of diabetes would be reduced. There had been only limited evidence of its safety, and over time it appeared to increase the rather than reduce the incidence of heart disease. The BMJ thought it should never have been licensed and should now be withdrawn which happened shortly afterwards. The information needed for licensing was likely to be reviewed, with a greater requirement for robust evidence on benefits and harms. Some drug companies, when presenting the results of clinical trials to regulators, might suppress information from those that showed no benefit - or indeed harmful effects. Meta-studies might mislead if, as had sometimes been the case, half the information available was not presented.
Drug warnings became common. In 2010 alone there was a caution that off-label use of quinine for leg cramps could result in serious and life-threatening hematologic adverse effects. Long-acting beta agonists were associated with an increased risk for muscle destruction; the opioid tramadol iwas linked to increased suicide risk; bisphosphonates used to treat osteoporosis had a possible increased risk for atypical femur fractures; and tigecycline was linked to an increased risk for death in patients with certain severe infections.
Some new drugs were costly and extended the life of those with an incurable disease, but did not affect the outcome. NICE, applying the criteria of cost effectiveness, might not approve them for NHS use. Patients faced with death which might be delayed by therapy not available within the NHS sometimes bought them personally, perhaps at the cost of thousands of pounds. However this might debar them from receiving normal NHS care at the same time and protests led the Secretary of State to commission an enquiry. In November 2008 Professor Mike Richards recommended that the Government, NICE and the pharmaceutical industry should act to ensure that more drugs were available for NHS patients on the NHS, but that those few that still wished to buy additional private care should not lose their entitlement to NHS care if the private element could be delivered separately from NHS care. The speed with which such drugs were referred for assessment by NICE should also be increased. Government accepted these recommendations.
The demand for imaging grew steadily. The results of treatment might be assessed by repeated imaging; the array of imaging tests increased. Over ten years the use of computed tomography scans had doubled. However radiological investigations, particularly if they were repeated, or in pregnant women or children, could lead cumulatively to a high dose and increase the risk of cancer. One estimate was that such radiation might be responsible for 2,000 cancers a year in the UK.
The technology available to radiologists had changed dramatically with IT, affordable high performance computers, digital imaging and picture archiving and communication systems (PACTS).(BMJ 2008: 337: a785) As a result, imaging and interpretation were no longer confined to one site. Remote assessment, already frequent in the USA, became more prevalent in the UK. Complex imaging procedures were frequently required in accident departments around the clock. Out-sourcing of interpretation was one way of dealing with increased demand coupled with a shortage of radiologists. Some English hospitals outsourced part of their work into Europe, as far away as Barcelona. Teleradiology and outsourcing had, however, their problems. Access to other test results or previous images was seldom possible, nor the easy communication with other specialties.
The steady improvement of imaging and nuclear medicine equipment provided better images and increasingly smaller radiation doses. The combination of CAT and positron emission (PET) scanning improved the diagnosis of heart disease and cancer. As the quality of imaging improved, unexpected findings were increasingly encountered, often of clinical relevance and unrelated to the purpose of the imaging. MRIs were usually requested to solve a specific clinical problem, but other small lesions, such as meningiomas, might be found. A new imaging system, laser based optical tomography, provided a new way of looking at the skin to a depth of 1mm.
From the 1930s to 1960s 14 classes of antibiotics were introduced. In the past thirty years only two novel classes of antibiotics had entered the market, oxazolidinones and cyclic lipopeptides, both used against Gram-positive bacterial infections. No new drugs against Gram-negative bacteria such as E. coli and K. pneumoniae had been marketed. Few were now under development - the profit on drugs used once, effectively, was lower than those for chronic conditions. The resurgence of life-threatening bacteria could cause a crisis, prompting leading bacteriologists to urge government, charities and industry to invest in research in this field. (Times 5 November 2011, WHO).. | Seven resistant bacteria: annual data collected in 27 EU countries, European Centre for Disease Prevention and Control |
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Methicillin resistant staphylococcus aureus (MRSA) first appeared in 1961 (methicillin was developed in 1951) but it was several decades before it became a problem. In the 1992 the number of strains that were resistant in hospital practice reached some 50% Now similar strains became more common in the community, in young fit people, sometimes with sports and soft tissue injury. Clinicians outside hospitals now had to be aware of this increasing hazard.
Septic shock was a major cause of death and one of the main reasons for admission to hospital intensive care units. Rapid recognition and immediate treatment was crucial to survival. The national imposition of systematic cleaning of hospitals and wards was associated with a reduction in the number of cases of MRSA and C. difficile. From 2008 onwards a new threat emerged, New Delhi metallo-lactamase 1 or NDM1. This was an enzyme that could live in different bacteria, which were then resistant to most antibiotics. Fifty cases in the UK were reported (and many more in India and Pakistan) in The Lancet, including E. Coli and Klebsiella pneumoniae, with some deaths. NDM-1 was becoming more common in Bangladesh, India and Pakistan and was starting to be imported back to Britain in patients returning from these countries. The main antibiotics for the treatment of gram-negative infections, β-lactams, fluoroquinolones and aminoglycosides - were no longer useful in these cases.
Easy travel and migration led to the re-emergence of tuberculosis as a public health problem. In 2009, 9040 cases of active disease were notified, a 75% increase over 20 years. Most occurred in people born outside the UK, often several years after arrival. Often presenting late and in marginalised populations, these groups were poor at adhering to treatment and were often highly infectious. Patients often originated in countries with a high prevalence of tuberculosis, and indeed of multiple drug resistance.
Annual numbers of HIV diagnoses in the UK doubled between 2000 and 2005 and had remained above 7,000 in each year until 2009. However highly active anti retroviral therapies2 (HAARTs) delayed the progression of HIV to AIDS, reducing HIV-associated morbidity and mortality. It was estimated that there were some 100,000 cases of infection in the UK, 20% undiagnosed, and late diagnosis was a major cause of treatment failure. "Get tested" was the message.
By the beginning of the decade there were more than 25 antiviral drugs from 6 therapeutic classes available for the treatment of AIDS. In developed countries multiple drug regimes were normal and most people who took medication achieved durable viral suppression. A new issue emerged, an increased incidence of disease in long term survivors. Classic AIDS related conditions were becoming less common but compared with a normal population "non-AIDS related" conditions were more prevalent. Heart disease, cancer and liver disease and conditions related to aging appeared most likely when treatment did not restore cell counts to the normal range. The care of patients with AIDS was becoming more complex.
In the 1970s many haemophiliacs had been infected by HIV as a result of substandard blood products. Lord Archer had reported on this in 2008 (Chapter 4) and in May 2009 the government expressed regret and increased financial compensation.
The number of new cases of variant CJD continued to decline, with one reported in 2008 and 3 in 2009 and 2010 with a total of 174 proven or probable deaths.
Even though malaria is not endemic in the UK, in 2009 there were 1,495 cases in those returning to or arriving in the UK, mostly in people who had travelled to or from African countries but a substantial number in people who had travelled to or from Asia, Far East, and South East Asia.
The risk of pandemic influenza had led to warnings of disaster for years, though neither severe acute respiratory syndrome (SARS) nor the small outbreaks of 'bird flu' in the Far East had affected Europe significantly. The threat of an epidemic had been the subject of detailed planning and concern about the ability of the NHS to keep the service running at a time of mass illness. In 2009 an outbreak of Swine flu (H1N1) with many deaths in Mexico created world wide anxiety. CDC Atlanta said it was probably impossible to contain it and its advice was designed to slow spread, not to contain it. Some countries reacted incoherently, for example slaughtering pigs en masse. Within weeks dozens of countries had cases, but they were most mild in nature. Indeed the normal victims of flu,. the over 65s, were less likely to contract the disease because of pre-existing immunity. The US Federal Government and manufacturers rapidly began to develop a vaccine against the novel H1N1 flu virus. In England antivirals such as Tamiflu (oseltamivir) were initially used prophylactically for contacts but this strategy of containment failed and the number of cases slowly increased, mostly in the young. Deaths occurred particularly in those with lowered resistance because of other diseases. Pregnant women and young children seemed particularly at risk but while the number of cases was much the same as those in a "normal" year, deaths did occur. In July 2009 the Chief Medical Officer, Liam Donaldson, spoke of a worst case scenario of 65,000 deaths. Fuelled by government and the media, public anxiety and the pressures on primary care grew. In July 2009 100,000 cases were recorded in a week. A National Pandemic Flu Service was launched (GPs were taken out of the equation) and a phone line and web site were established - less than one in twenty callers actually had the disease. 44 million doses of the newly developed vaccine were eventually purchased (more were initially ordered) and in October 2009 vaccination began. The take-up was understandably low. The service made antiviral drugs available directly to the public if they gave a history suggestive of infection . Comparatively few picked up the drugs for which they had asked. A revised assessment by the Cochrane collaboration threw doubt on the ability of oseltamivir to reduce complications in otherwise healthy adults. Serious illness other than influenza might be misdiagnosed and some undoubtedly suffered because diagnosis of their real illness was delayed
While the Secretary of State, Andy Burnham, said England had come through the epidemic because of the strength of plans, this was clearly not so. Nobody seemed to have thought of a pandemic so mild that it would cost fewer lives than normal seasonal flu. In January 2010 the weekly case rate was below 5,000. Only a third of the vaccine purchased was used, and attempts were made to dispose of the surplus. Post-mortems began; had public health doctors over-reacted? Had the pharmaceutical industry created a panic to increase the sales of their vaccines? Had money been wasted? Would anyone believe predictions again? It was hard to say any one decision was wrong, but once the concern was there, one step followed another with grim inevitability. (Hawkes N, BMJ 2010;340c:789) The Social, Health and Family Affairs Committee of the Council of Europe, reporting in June 2010, criticised WHO, national governments and the EU agencies for the handling of the epidemic, "a pandemic that never was" and a waste of large sums of public money. There had been lack of transparency about how decisions had been taken and possible conflicts of interest. One commentator said that "money spent in stockpiling antivirals with hypothetical effectiveness against a hypothetical pandemic is not available for health care, or for education or for any other important human need." The swine flu pandemic cost Britain more than £1.2bn despite being much less severe than feared, a government-commissioned review found. The actual death toll during the outbreak was 457, not 65,000. The report by a public health colleague of the CMO believed that the response had been "proportionate and effective" though not all agreed.
The following year, 2010/11, influenza appeared and swine flu infections were again apparent. Though the death rate was not high, the disease affected an unusually high proportion of young people. The facilities for extra-corporeal membrane ventilation were increased, to cover the number of people in intensive care with breathing problems.
E. Coli
A significant outbreak of Escherichia coli 0157 in September 2009 started in a Surrey farm open to the public, where animals could be fed and petted. Ninety three people were involved, 76 children under ten. Some became seriously ill, requiring renal dialysis. An enquiry concluded that laboratory closure over a bank holiday weekend, incorrect advice and delay in restricting access to the farm - fundamental failings in the handling of the outbreak - increased the number of cases. Found on almost 40% of cattle farms, risks might be minimised but could not be eliminated.
An far more serious outbreak occurred in Germany in May 2011, difficult to trace but ultimately linked to bean sprouts from an organic farm in Lower Saxony. More than 4100 people in 12 countries including France and the UK were infected, all of whom had travelled to Germany, and 49 deaths. The new strain, enterohaemorrhagic E. coli (EHEC ) was an aggressive hybrid toxic to humans and not previously linked to food poisoning. Its source was hard to determine, and first bean shoots grown on an organic farm in Germany and then fenugreek seeds imported from Egypt were blamed. In over 700 patients it led to haemolytic-uraemic syndrome (HUS), with kidney failure. Instead of affecting many children, a lot of patients were adult women, well educated, and food conscious. Restaurants were part of the chain.
As a result of lower levels of immunisation against measles, the numbers of cases continued to rise peaking at more than 1000 in 2008. Immunisation programmes were introduced to deal with local outbreaks. The level of infections fell.
Immunisation against human papillomavirus (HPV), a virus that causes cervical cancer, was offered to 12-13 year old girls from September 2008, and before long 70 per cent of 12-13 year olds had had their first of three vaccinations, a high rate of uptake. It was decided to to cover 13-17 year old girls more rapidly.
Changing demand for surgical procedures brought forth new subspecialties. Bariatric surgery increased rapidly year on year, so that by 2008 some 10.000 such operations were being carried out annually, mainly in the NHS but also in the private sector. People were increasingly aware of the possibility of an operation and might even eat to gain a weight that would qualify for health service care. The incidence of diabetes type 2, heart disease and health generally improved after surgery and the operation paid for itself in reduced costs to the NHS over a few years.
Cosmetic surgery was increasing rapidly, 90% in women and often in the private sector as a lifestyle choice. There was little regulation and a grey area between cosmetic surgery by fully trained professionals, and cosmetic procedures undertaken in beauty salons where staff might have little training and use of injectable fillers of uncertain origin. The revelation that a major producer of breast implants, that went out of business, had used substandard silicone gel in prostheses with a high rupture rate led to calls for regulation and better record keeping.
Two new minimal access techniques were under development. Natural orifice endoscopy used a natural cavity such as the rectum or vagina for access, avoiding the need for an external scar. Single port laparoscopy involved, instead of several stab incisions providing surgical access, only one at the umbilicus, again avoiding scaring. Appendicectomy, cholecystectomy and even partial colostomy were possible in this way which its protagonists thought was safe in well trained hands, virtually scar less, and of reasonable cost..
The scope of tissue transplantation was widening. Over the previous ten years intestinal transplants moved from an experimental to a more regular procedure, usually performed for people with a short gut as a result of Crohn's disease or the removal of tumours. In intestinal failure, the intestines can't digest food or absorb the fluids, electrolytes and nutrients essential for life. Patients with intestinal failure who developed life-threatening complications from total parenteral nutrition (nutrition into a vein) could now be considered for gut transplantation with or without other organs such as the pancreas and liver, with a good chance of 5 year survival.
A pioneering biomedical engineering operation allowed the implantation of tissue grown outside the body. After many years careful laboratory, immunological and animal work, a joint team from Bristol, Spain and Italy collaborated in the removal of a main bronchus largely blocked by tuberculosis that had led to lung collapse, and its replacement with a new piece, without the need to use drugs to suppress tissue rejection. They began with a 7 cm segment of trachea from a 51 year old woman who had died of a brain haemorrhage. After stripping the trachea of all its potentially antigenic cells, the scientists reseeded the cartilage scaffold with cells from the recipient—a culture of epithelial cells from her own right bronchus for the inside of the graft and chondrocytes transformed from her own stem cells for the outside. They grew both types of cell in specially adapted cultures before being transferred to the graft over four days in a newly developed bioreactor. Many months after surgery she remained in good health. In a further development a nanocomposite polymer was produced at the Royal Free Hospital which then acted as a scaffold for the patient's own bone marrow cells, which was then transplanted in Sweden.
The demand for transplants continued to exceed the supply of organs. With a waiting list of 10,000, three people died in the UK every day because of the lack of a suitable organ. NHS Blood and Transplant accepted the growing practice of offering patients organs that were less than ideal, for example lungs from heavy smokers or livers from people who had died in their seventies, the choice being death while waiting or a high chance of survival..
An increasing understanding of how important it was to the very severely injured to be treated in a major trauma unit handling many such cases, led to reorganisation of the service. According to a National Audit Office report the UK death rate was 20% higher than in the US. London established a metropolitan wide trauma service based on four major trauma centres, The Royal London Hospital, Whitechapel, King’s College Hospital, St George’s Hospital, Tooting and St Mary’s Hospital, Paddington to which ambulances would preferentially take such cases.
The conflicts in Iraq and Afghanistan had been accompanied by the development of new forms of weaponry, in particular improvised explosive devices. These led to severe injuries often characterised by severe blast damage, flying debris, crush injuries and major burns. Blast injuries to the brain were common and military surgery techniques developed rapidly to deal with these problems. The effectiveness of the medical care was such that 90% of those seriously injured now lived, albeit often with horrendous injuries. In Germany there was a tertiary care hospital and to this injured soldiers were rapidly evacuated.
The earthquake near Port-au-Prince in Haiti in January 2010 showed how a disaster, if it decapitated a country by removing its centre of government, health service, police and transport facilities, could create vast difficulties for international relief effort. Organisations such as Médecins Sans Frontièrs (MSF) struggled to provide aid in a country with no functional port and minimal airport facilities, in the face of some 200,000 deaths and vast numbers of crush injuries. This was in contrast to the coordinated response in Japan to the earthquake, tsunami and nuclear power station problems of 2011.
Hip replacement was perhaps the most successful orthopaedic operation ever and 70,000 are performed annually in the UK. A variety of operations are performed.
Metal-on-Polyethylene: The ball is made of metal and the socket is made of plastic (polyethylene) or has a plastic lining.
Ceramic-on-Polyethylene: The ball is made of ceramic and the socket is made of plastic (polyethylene) or has a plastic lining.
Metal-on-Metal: The ball and socket are both made of metal.
Ceramic-on-Ceramic: The ball is made of ceramic and the socket has a ceramic lining.
hip joint resurfacing
The conventional metal on polyethylene hips do not last for ever; wear means that revision is required particularly in younger active patients. In search of a more durable option, metal on metal replacements were developed, increasingly accurately machined. However there was increasing concern about these replacements. Because the metal ball and the metal cup slide against each other during walking or running, some tiny metal particles may wear off and enter into the space around the implant. Some of the metal ions from the metal implant or from the metal particles may even get into the bloodstream. As a result patients could develop pain, swelling and permanent disability. Revision operations were needed and problems became particularly apparent with the DePuy ASR, introduced in 2003 and withdrawn by the manufacturer in 2010 when some 93,000 had been produced. The process of approving and monitoring medical devices seemed in need of improvement..
For some 20 years coronary angioplasty had been available and increasingly used in the acute phase of a heart attack. In 2008 the Department of Health recommended that primary angioplasty should take over from thrombolytic drugs as the first line treatment for myocardial infarction, as it was associated with lower mortality and better long term outlook if carried out within 3 hours of onset. Ambulance services collaborate closely with their receiving hospitals and networks, the focus shifting from provision of early thrombolytic treatment outside hospital to identifying those patients with a heart attack who might benefit from primary angioplasty and rapid admission. Cardiac Networks (also known as 'heart and stroke networks' since they facilitate improvements in stroke care) were made up of clinicians, managers, commissioners and patients who work together to coordinate every aspect of patient care .
Steady progress was made with total implantable artificial hearts. The Jarvic 7 (first used in 1982) was joined by the CardioWest™ Total Artificial Heart, developed in Tucson Arizona. By 2009 this had been used in over 800 patients. Often used to buy time in a seriously ill patient while a heart transplant match was found, it was used at the Cleveland Clinic early in 2009 for the world's first Total Artificial Heart to double heart and liver transplant. This artificial heart transplant was successful 4 times out of five, and the subsequent success of heart transplantation was one-year and five-year survival rates of 86 and 64 percent.
Once a sub-specialty of general surgery with a surgeon undertaking vascular arterial procedures for part of his or her time, (repair of abdominal aortic aneurysms, carotid stenosis and surgery on arteries in the leg), vascular surgery emerged as a specialty in its own right. Clinical evidence showed that patients achieved the best outcomes following surgery at a high volume hospital, by a vascular specialist team including surgeons and radiologists.. In London 75% of surgery took place in six hospitals and 25% is spread across another 12. To improve outcomes, it was planned to concentrate surgery in London at fewer centres.
Patients with significant narrowing of their carotid arteries are at increased risk of stroke. Those with transient symptoms have the highest risk of stroke in the period immediately following the ons
et of symptoms. There is much evidence
showing that the greatest benefit from carotid operation is seen if the
procedure carried out quickly following onset of symptoms. Both NICE and the
National Stroke Strategy have set targets for the time from symptoms to
intervention but access to immediate assessment and surgery varied widely, being
worst in small volume units and best where services were linked to a large
centre always able to provide urgent care, as in London where a few hyperacute
stroke centres were created.. In skilled hands the risk of stroke and
death from operation was no more than 3%. Clinical trials of stents showed
that the short term hazards were not as good as after surgery, with more
ischaemic events. Results were improving, but open operation was still
safest.
Technological improvements led to the development of better diagnostic equipment, for example simpler equipment to test for glaucoma, or to image the retina. Multifocal lenses were tried in the treatment of cataract, but did not prove wholly satisfactory. Drugs for the treatment of glaucoma, Avastin and Lucentis, were approved for general use by NICE and success was reported in the use of stem cells in the treatment of a rare form of inherited blindness, Leber's congenital amaurosis.
Age related macular degeneration, earlier treated by laser, was increasingly managed with an anti-vascular endothelial growth factor drug (administered into the vitreous), representing the era of biological medicines for the management of neovascular disease. Stem cell treatment was also under development.
Survival in the UK from cancer still lagged behind other European countries, with 250,000 diagnoses annually in England, and 130,000 deaths. Earlier diagnosis was an aim - a quarter of cases were first diagnosed in an emergency situation.
Photodynamic therapy (PDT) was added to the classic treatments, radiotherapy, surgery and drugs. It was increasingly used at major centres, e.g. University College Hospitals London, and the Christie. A drug, called a photosensitiser and a specific wavelength of light produced a form of oxygen that killed nearby cells. A photosensitising agent was injected into the bloodstream, absorbed by cells all over the body but stayed in cancer cells longer than in normal cells. Approximately 24 to 72 hours after injection, when most of the agent had left normal cells but remained in cancer cells, the tumour was exposed to laser light. In addition to directly killing cancer cells, PDT appeared to shrink or destroy tumours in two other ways. The photosensitiser can damage blood vessels in the tumour, preventing the cancer from receiving necessary nutrients, and it may activate the immune system to attack the tumour cells. Because the light can only pass a short distance through tissue, it is predominantly used for the treatment of cancers of the skin and of linings of internal organs. Research studies were evaluating PDT for cancers of the brain, skin, prostate, cervix and the peritoneal cavity, and the development of photosensitisers that are more powerful, more specifically target cancer cells and are activated by light that can penetrate tissue and treat deep or large tumours.
High energy proton beam therapy, which could deliver high doses accurately localised and manage some tumours not otherwise treatable, had been available in several US centres and elsewhere, but not in the UK. Some patients were sent to the US for treatment. Bids for equipment were encouraged from suitable centres in this country.
To the hundred or more drugs already in use for cancer, some 40 more were heading towards a licence, mostly effective and all expensive. Most derived from new knowledge of how cancer cells worked, and it became essential to develop new tests of effectiveness. In 2008 the American Society of Clinical Oncology in its annual report listed many advances in that year, often small but in total increasing the chance of a favourable outcome. They included
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Malignant melanoma of the skin was now the most common cancer in young women, increasing significantly over the previous ten years. The increase seemed associated with tanning and sun beds, and warnings of the health risks did not seem to be taken seriously by the young. The BMA had campaigned for controls on their use, and a private members bill was introduced in 2010 to restrict their use by those under 18 years of age.
Screening for bowel cancer by testing faeces for blood was introduced in the UK in 2007 and was scheduled to cover the whole country by the end of 2009. Computer simulation suggested that it might save 2500 lives annually in the UK. However one-off 5 minute screening by flexible sigmoidoscopy, (colonoscopy was already widely accepted on a five yearly basis in the USA for those over 55yrs), was shown in a prospective trial by workers at Imperial College to reduce mortality by 43% compared with controls, as it offered the chance to remove polyps that might be pre-cancerous.(Atkin S et al, Lancet Online 28 April 2010) For every 400 patients screened, one life would be saved.
Mammographic screening was more contentious. There was increasing concern about the damage from unnecessary operations following screening, particularly as the public information leaflets seemed to underplay the risk. In both Canada and the USA, taskforce guidelines discouraged routine mammography before the age of 50, and suggested screening at wider intervals, 2-3 years.
Radiotherapy techniques advanced, and proton beam therapy became available at Clatterbridge Hospital, Wirral. Other hospitals were invited to bid for funds for it. Proton Beam Therapy (2009), then being used at a dozen centres in the USA, could cure tumours without damaging vital organs. Because of their relatively large mass, protons do not scatter much in the tissue; the beam does not broaden much and stays focused on the tumour shape without much damage to surrounding tissue. All protons of a given energy have a certain range; no proton penetrates beyond that distance. Although applicable to comparatively few patients, some, especially children, with highly specific types of cancer that occur in the retina, base of the skull and near the spine, this form of treatment could be better than conventional radiotherapy as it targets the tumour precisely, giving better dose distribution and not harming vital organs.
Medical genetics was coming of age and there was pressure for increased investment by the NHS. For twenty years knowledge had increased of the genetic causation of some diseases, opening the path for the development of treatment and leading to therapies that altered the patient's genetic structure, as in eye disease.
When a child had an unexplained congenital disorder, its genome could be compared with its parents, to spot the difference.
Genetic testing of a tumour could identify mutations that might be targeted by "smart" drugs.
The genome of bacteria cold be "fingerprinted" to trace and eliminate the source of outbreaks.
Human embryonic stem cells, first grown in 1998, could now be developed to the point of differentiation into different tissues in sufficient quantities for use in animal trials. In 2010 surgeons in Atlanta, in a hospital specialising in brain and spinal cord injury, injected a spinal cord injury patient with human embryonic stem cells in a federally approved trial to determine safety and the following year a trial of stem cells in multiple sclerosis began.
In 2009 the mapping of the genome of two patients with cancer (lung and malignant melanoma) showed that each had tens of thousands of abnormal mutations. Which were related to the cancer was not clear, though it was calculated that there was a mutation for every 15 cigarettes smoked. It was however likely that as more patients were mapped, relevant mutations would be identified, opening a route to the development of new drugs and better treatment.
Women with a BRCA1 mutation have an 80% chance of developing breast cancer and a 60% chance of developing ovarian cancer during their lifetime. In 2009 the first baby was born in the UK as a result of pre-implantation genetic diagnosis and in vitro fertilisation, as a result of which not only would she be likely to avoid these diseases, but she would not pass the increased risk on to her own children.
Flexible endoscopes and colonoscopes had made it possible to examine perhaps half of the gastro-intestinal tract, but the procedure was uncomfortable and usually required sedation. A new test became possible with the development of a PillCam that could be swallowed. It combined a camera that could take 5-30 photos a second, with LED lighting, batteries and a radio transmitter. Organ-specific PillCams were developed for the oesophagus (which could look forwards and backwards), the small bowel, and the colon. The device was particularly useful in diagnosing bleeding of obscure origin, and cancer of the colon in people who refused conventional colonoscopy.
Until the 1990s patients with this disease were treated with aspirin or non steroidal anti-inflammatory drugs and.modifying anti-rheumatic drugs such as methotrexate were only introduced when the disease had progressed. As a result there was substantial permanent joint damage. Many new drugs now became available, most being "biologicals", developed and produced in live cell systems. With better control and assessment, these drugs were now used much earlier to retard the progression of the disease but had significant side effects.
Guidelines promoted the use of the haemoglobin A1c (A1c) as a faster, easier diagnostic test that could help reduce the number of undiagnosed patients and better identify patients with prediabetes. A1c measures average blood glucose levels for a period of up to 3 months. Previously it was used only to evaluate diabetes control with time, but because it doesn't require fasting, A1c testing encourages more people to get tested, leading to treatments and lifestyle changes that could prevent the worst effects of the disease
Hopes of better treatment for multiple sclerosis, a serious and disabling disease of the brain, were raised in 2008-10 by trials of monoclonal antibodies, e.g. Alemtuzumab, that target CD52 on lymphocytes and monocytes. 3 large randomized trials of 2 new oral medications for relapsing-remitting multiple sclerosis (MS) showed they reduced the risk of sustained accumulation of disability compared with a previous drug, but had dangerous side effects. Adverse effects were in some cases serious, even lethal. Herpetic infections were seen with both drugs and resulted in 2 deaths in the trials and thrombocytopenic purpura developed in three patients.
Stroke services became a national priority. Extra stroke physicians were funded and all hospitals created a stroke unit though many did not offer an immediate scan, and while the aim was to admit all patients to the unit, this often did not happen. If patients with symptoms of stroke were to receive the rapid imaging necessary within half an hour of admission before thrombolysis was considered, reorganisation of services was necessary. In London, eight hyperacute stroke units were established to which all patients were admitted rather than the nearest hospital. Diagnosis by ambulance personnel proved highly accurate and virtually every patient needing thrombolysis got it, some 18% of admissions. Mortality from stroke fell 20-30%. These units were supported by stroke recovery units and transient ischaemic attack services for possible minor strokes. Outside the conurbations, this model was harder to apply and while nationally stroke mortality fell somewhat, perhaps only one in three of those who would benefit from thombolysis got it.
The care of the elderly in hospital, when assessed by regulators, was frequently found wanting. The defects became coupled in the public mind with deficiencies in nurse training.
There had been a major drive to ensure that all dying patients, and their relatives and carers, received a high standard of care in the last days of their lives. The Specialist Palliative Care Team at the Royal Liverpool University Hospitals and the Marie Curie Hospice, Liverpool developed the Liverpool Care Pathway for the Dying, (LCP). The LCP was recognised as a model of best practice and recommended in the NICE guidance on supportive and palliative care for patients with cancer (2004) as a way of identifying and meeting the needs of dying patients. It prompted staff to consider the continued need for invasive procedures and whether current medications really were conferring benefit. The clinician has the opportunity to follow the LCP guidance or to record the reason for decisions to determine a plan of care that deviated from this. It required regular assessment and involves continuous reflection, challenge, critical decision-making and clinical skill. The LCP, though widely welcomed, was criticised in some quarters.
"Organised scepticism", the requirement that scientific claims be exposed to critical scrutiny before they are accepted, had never appealed greatly to proponents of alternative medicine. Some of them believed that scientific principles just could not be applied to forms of therapy that were intensely individual, though others were keen to accept the trappings of tradition, the white coat and the appellation "doctor". Promotional materials were quick to reference studies that, when examined, proved either to be poor in quality or to be selectively or inaccurately quoted. Occasionally people whose scientific claims were questioned turned to the law to attempt to silence critics, rather than engaging in scientific debate. Sometimes they succeeded, but not always. The editor of the New Zealand Medical Journal , when chiropractors threatened to sue over an article asked them to 'provide evidence, not your legal muscle.' A US judge dismissed a device manufacturer's law suit by saying that the dispute should take place in the pages of the journal, not in a Court.
Government, consulted in 2009 on proposals for statutory regulation of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems. In 2010 the House of Commons Science and Technology Committee reported that as there was so little evidence for homeopathic treatment, the Government should stop allowing the funding it on the NHS, and the funding of homeopathic hospitals - hospitals that specialise in the administration of placebos- should not continue. The Royal London Homeopathic Hospital changed its name to the Royal London Hospital for Integrated Medicine, as only a minority received homeopathic treatment.
Proponents of alternative medicine frequently argued for "more research" while being loath to accept results when they were forthcoming. An assessment of good trials for chondoitin and glucosamine in osteoarthritis showed that they did not reduce joint pain or have an impact on narrowing of joint space, while apparently having no ill effects. Yet these products were widely advertised, for example on the back of busses, and widely sold. Sometimes they were prescribed on the NHS. Why?
The Confidential Enquiry into Maternal and Child Health became one four Clinical Outcome Review Programmes commissioned by the Healthcare Quality Improvement Partnership on behalf of government departments.
The Clinical Outcome Review Programmes which now encompass Confidential Enquiries are designed to help assess the quality of healthcare, and stimulate improvement in safety and effectiveness by systematically enabling clinicians, managers and policy makers to learn from adverse events and other relevant data. The programme aims to complement and contribute to the work of other agencies such as NICE; CQC, the Royal Colleges and academic research studies with the aim of supporting changes that can help improve the quality and safety of healthcare delivery.
There are of the Department of Health, England, NHSSPS Northern Ireland, NHS Scotland and NHS Wales, the Channel Islands and the Isle of Man.
Service provider contracts for these programmes were awarded in March 2011 to the following suppliers:
The pattern of maternity care was changing. Fifty years previously maternity had been the bed-rock of general practice - if one looked after a mother one gained the family and obstetric qualifications were valued in a new partner. Over half deliveries were at home. As hospital services expanded, "shared care" became the aim, GPs doing much antenatal and postnatal care with midwives attached to their practices. However over the years as the number of deliveries at home and in local units fell, GPs became less involved, less expert and - in medical school - less well trained. They became reluctant to be involved in care during labour sensing their inadequate experience and being less available outside normal hours. Under the 2004 contract GP maternity services were no longer paid for separately but as part of the global income, removing the incentive to involvement. Government and NICE policy documents now hardly mentioned GPs as participants in care. The King's Fund reported that midwives were now the main health care providers for ‘low risk’ pregnancies. Mothers could no longer turn to their doctor in the same way and there was a risk of failure to ensure relevant information was shared among GPs, midwives and hospitals. Pregnant women wanted continuity of care and post-natal support which was in danger of being lost.
Childbirth had never been safer and as the results of Caesarean section improved, NICE controversially proposed that mothers be offered the choice of type of delivery and allowed to have a section as long as they were counselled about the risks. Antenatal care was reviewed, additional screening tests added and complex systems introduced to monitor antenatal and intrapartum care. However technology was used not only to improve health care but to avoid legal claims. All babies had to be perfect, so caesarean section rates remained high. Recordings of babies' hearts were kept indefinitely by some units, as in their absence a future claim by parents of a handicapped child would be hard to defend. Babies had electronic tags to make abduction difficult. In a society characterised by some as "me too", patients would complain if their requirements had to wait while others received attention.
The rise in the number of births strained maternity services. In 2010 there were 723.165 babies born in England and Wales. The number of births has increased each year since a dip in 2001, when there were 594,634 babies born. Increases in births were being driven by two main factors – increasing fertility rates among women born in the UK many of whom had delayed child bearing, and the increasing population of non-UK born women of childbearing age. Probably because of the increasing number of pregnancies in older mothers, the number of cases of Down's syndrome was increasing - from 1,075 diagnoses in 1990 to 1,843 by 2008 in England and Wales. Because of improved antenatal screening more Down's pregnancies were spotted and more abortions took place. About 180,000 abortions were performed annually in England and Wales, roughly 17 per thousand women aged 15-44 years. Virtually all were paid for by the NHS, roughly half being carried out under contract in the private sector. In some hospitals it was the commonest day surgical procedure. |
Source: Office of National Statistics website |
More babies needed neonatal care because of:
The survival of small babies imroved as the details of care, monitoring and biochemistry were better understood. Below 23 weeks gestation the outlook was poor, but after that with each succeeding week results were better. At 26 weeks babies stood an excellent chance of survival, particularly if they were delivered in, or rapidly transferred to, a large and experienced intensive neonatal care unit. Such units might have 4 or more neonatologists (spending more than half their time on the specialty and ventilating perhaps 8 or more babies at a time) but had significantly better results than the smaller more numerous paediatric intensive treatment units. Transfer before delivery was best when a mother went into premature labour, but the capacity of labour wards sometimes made this difficult. In 2009 the Department of Health issued a "tool kit" of recommendations aimed at developing clinical networks and increasing the quality of care.
Screening of the newborn for metabolic disease has started in the 1960s with tests for PKU (phenylketonuria). Additions were soon made and the list expanded in England to include congenital hypothyroidism, cystic fibrosis, sickle cell disease, and Medium Chain Acyl CoA Dehydrogenase Deficiency. It was also easy to screen for galactosaemia and in North America the list of conditions for which screening was undertaken could be far larger, including biotinidase deficiency, congenital adrenal hyperplasia, homocystinuria, maple syrup urine disease and tyrosinemia. One private clinic would test for 20 different conditions, and genetic testing added to the possibilities.
How many beds? Between 1955 and 1995 the number of beds for mental illness and learning disability fell from 150,000 to fewer than 55,000. Over the next ten years there was a further reduction of 30%, care increasingly being delivered by community based teams. While the number of admissions (perhaps for depression or dementia) fell, the number of those admitted 'involuntarily' increased by 20%, particularly for drug and alcohol problems. Admissions for psychosis remained roughly constant. The case-mix of inpatient facilities was changing as the number of beds continued to fall, and increased use was made of private facilities contracted to the NHS. BMJ 2008;337:a1837
Mental health policy had been based on the national service framework for mental health (1999), centrally agreed standards and a uniform model of care, home treatment, assertive outreach and early intervention teams. In 2009 the Secretary of State Andy Burnham published New Horizons, a shared vision for mental health, which grouped actions under a number of key themes:
In 2011 this was superseded by a Coalition strategy, No Health without Mental Health. Its objectives were that more people should have good mental health and more of those that did not would recover, those with problems would have good physical health, would have a positive experience of care, fewer would suffer avoidable harm, stigma or discrimination. There was a commitment to improve access to psychological treatment and early intervention. The pressure on financial resources meant that the strategy did not include costly action plans.
The steady rise in the number of people with dementia, the costs incurred and the doubts about the effectiveness of treatment led in 2009 to the publication of a national dementia strategy, Living well with dementia. It aimed to ensure better knowledge and earlier diagnosis of dementia, and to improve care. Better and more coordinated local services, including memory clinics, were required. Little advance, however had been made in the prevention or treatment of the condition. Pressure groups commissioned studies showing that there were far more patients than had been estimated, perhaps some 800,000, and called for more research into the increasing problem.
The way care was provided was changing. GPs were more involved in health promotion and the care of long term illnesses, but far less in maternity services, now largely the province of midwives and the hospital services. Continuity of care suffered with longer surgery hours and more part time working. In 2007 the Royal College of General Practitioners, considering how primary care might be delivered in the future, published a "Road Map" the key idea being that doctors and their practices might come together in "federations" to deliver better services in a more cooperative way. Federations might strengthen the capacity of practices to develop new services out of hospital, form an organisation that could tender for services, make efficiency savings/economies of scale, for example in back office functions, improve local service integration across practices and other providers, strengthen clinical governance, improve the quality and safety of services, and develop training and education capacity. Many practices began to develop networks or federations, to try to improve care, commission or provide services or both. The Coalition White Paper with its proposals for GP commissioning groups added a new impulse. The RCGP, with Nuffield and the King's Fund, published a toolkit to assist practices to develop new structures and learn from others' experience. The Coalition, believing that PCT commissioning had failed, planned to establish 5-600 GP consortia to take over this task, being directly responsible to a new Independent NHS board, and contracting directly with providers. (see organisational change)
Government continued to press for increased community based services, e.g. the 2008 Transforming Community Services (TCS) programmes and in London, where accommodation was often poor, the polyclinic concept in Darzi's reports became a two year programme for 20-30 polyclinics across London by 2012. While never tightly defined, polyclinics aimed to combine GP and some elements of hospital care with a range of health and support services such as benefits support and housing advice. General practices, a walk in clinic, investigations such as breast cancer screening and consultant sessions in for example cardiology and ophthalmology, might be co-located. Services such as X-rays and blood tests would be available. They were open from 8am to 8pm every day including at weekends and available to people even if they were not registered there.
The subsequent financial crisis and a change of administration compromised the ability of primary care trusts to redesign their systems. Projects identified as polyclinics differed because of local patient needs, priorities and physical and organisational legacies. No two were alike and there was difficult reconciling local realities and imposed policy expectations. Some were developed around existing systems. Others were new, for example Heart of Hounslow, and the Loxford Clinic in Redbridge, opened in 2009 providing the premises for a practice, consulting rooms for specialties such as dermatology and ophthalmology, modest imaging facilities - but no parking. Few examples of polysystems achieved the goal of community nursing and social service integration. With a capital cost of £6.5 million and £2.5 million on equipment whether this was an effective use of resources was unclear. An evaluation of polyclinics was commissioned financial stringency reduced the pressure to implement the policy.
In 2008 the Public Accounts Committee delivered a damning report on GP pay and the earlier contractual negotiations. Pay had risen an eye-watering 58% but targets had been set too low and the 2003/4 contract had failed to live up to expectations. Gordon Brown, the Prime Minister, made extended surgery opening a priority. After acrimonious negotiation general practices accepted the changes to the contract for 2008/09, which would give GPs financial incentives to provide longer opening hours. [How GPs are paid]
Over 10-20 years the number of salaried doctors steadily increased until, in 2009, probably some 40% were on a salary. Salaried practice often suited young doctors and large and business-like partnerships might take advantage of the situation. While the British Medical Association had a model contract, only a third of salaried doctors used this. Primary care trusts (PCTs) were having an increasing influence on practices. A practice might find the PCT willing to fund new staff members in the practice team, for example a physiotherapist providing open access to patients or a psychotherapist. The PCT could bring pressure on practices to extend their hours of opening as well as use the quality and outcomes framework as an incentive.
The Alterative Provider Medical Services Contract (APMS) allowed primary care trusts to contract services from groups outside the NHS, including commercial and voluntary organisations. PCTs were slow to do so, mainly using the system to fill specific requirements but by 2008 some 100 practices were being run by alternative providers and it was GP-led companies that had been most successful in bidding for these contracts. Corporate providers and social enterprises had been successful in a minority of cases. GPs had an inbuilt advantage in that while they might be strangers to the complex process of tendering, they had local knowledge and the financial advantage of remaining within the NHS pension scheme. Some supported this development as encouraging innovation and challenging the existing pattern of delivery; other saw it as an aggressive commercial take-over of general practice. The policy risked spending money on services in places where they were not really needed, or destabilising local practices providing a good service.
The Department of Health invested most of the £250 million spent, but many centres were imposed on PCTs where they were not required. By the the election in 2010 12 had opened, 7 in London. Andrew Lansley saw the programme as a 'top down, one size fits all' approach and the policy began to unravel. One centre in Stockport, labeled as unnecessary and costly duplication, was closed. Others would probably continue where they had been put in the right place and were fulfilling a genuine need, although they seemed to have no effect on reducing hospital attendances. Similarly, Walk-in Centres did not have proven advantages in a time of retrenchment, and some closed.
Concern continued over the provision of services out of hours since NHS GPs had transferred their responsibilities to primary care trusts. Running the services proved difficult; a few went out of business suddenly. Complaints increased substantially. Because it was hard to recruit local doctors, PCTs and the organisations with whom they contracted might look far and wide for staff, often to Europe. Reports suggested that at best only one in four of people requesting a visit got one; it might be far fewer and "telephone diagnosis" was common. The population covered by an out of hours deputy might vary from 30,000 in some areas to 300,000 in others and PCT spending on services varied widely.
It was hardly surprising that failures of the system might be dramatic and attract national interest. The death of a patient given ten times the normal dose of heroin by a German locum led the Care Quality Commission to investigate the arrangements in 5 PCTs and, recognising a wider problem, to "encouraged PCTs across the country to scrutinize in more detail the out-of-hours services they commissioned". The Times (4 February 2009) described the out of hours service as a disaster and an avoidable one, as a result of the way the Department of Health had, during contractual negotiations, allowed out of hours care to move from GPs to PCTs at minimal cost to the doctors. A review by the Department of Health and the RCGP (strangely described as 'independent') laid the responsibility on SHAs and Primary Care Trusts, largely absolving GPs from responsibility. A memorandum by the Department of Health to the House of Commons Health Committee (2010) about overseas doctors contained information about their numbers, credentials and quality control issues. The Conservatives believed that re-negotiation was called for, to return responsibility for out of hours care to local doctors.
From 2009-2011 the King's Fund commissioned research and assessed expert opinions, because though much activity took place in general practice, most research is within the acute services. In its Inquiry into the Improving the Quality of care in General Practice, the Fund said that while standards and quality were generally good, there was room for improvement. The lengthy report provided an important reference source. Variations, sometimes unacceptable, were found in quality of diagnosis (for example cancer) and prescribing. Referral rates also varied, with little relationship to patient outcomes. Patients were might be unable to see their preferred doctor rapidly, preferring to wait for him or her, and continuity of care and its coordination might be lacking. There was a lack of data, and of transparency about what was being done. Doctors needed to adapt more to the changing world, technology and patients' expectations. Without much supporting evidence, the inquiry thought that a move from isolated practices to federated networks was required and radical change was needed, a new deal for patients, and a change from the practice as a gatekeeper to a navigator within the NHS. The inquiry wished to find new measures of quality in primary care, "a task we were unable to complete." [See BMJ review by Nigel Hawkes]
The Quality and Outcomes Framework (QOF), introduced in 2004 and accounting for some 15% of primary care costs and up to a third of a practice's income, was improving the process of care as far as the conditions covered by the framework though possibly other aspects such as personal and continuity of care were sacrificed in the process. A system of financial incentives, it covered clinical care, organisation, patient experience and additional services. Consistent improvements were recorded for intermediate outcomes such as blood pressure and cholesterol, and secondary prevention was promoted. Significantly, practices in deprived areas achieved similar levels of cover to practices in more affluent areas and was seen as a way of reducing inequalities of care. The framework was altered regularly, seven times by 2010. It was supervised by primary care academics, overseen by the RCGP and lay representatives, and from 2009 incorporated advice from NICE. The challenge was discarding less effective components, introducing new ideas and considering value for money. From a focus on structure and process in common chronic conditions, it increasingly took account of disease prevention and outcomes.
Most GPs did not take their own phone calls out of surgery hours and there was a reliance on systems of triage. Studies suggested that the decisions taken by "triagists" varied and that a substantial proportion of decisions were wrong. Outcome studies did not reveal many problems as a result, possibly because most calls were only about trivial matters. Advice was given after asking too few questions, and without properly interpreting the answers. There were significant dangers to patients and the protocols used were hard to assess because they were not publicised, nor available on-line allowing them to be studied.(BMJ 2008:337: a1167) The Healthcare Commission, reporting on emergency and urgent service in September 2008, found gaps and variation in performance. In 65% of areas, out-of-hours GP services met the requirement that they started telephone assessments within 20 minutes of a patient’s initial contact if a patient’s needs were urgent, and within 60 minutes otherwise. In some areas, less than 80% of assessments are started within these timescales. NHS Direct exceeded the target for starting telephone-based assessments within 20 minutes for urgent calls (priority 1) and 60 minutes for other urgent calls (priority 2) in 95% of cases. It achieved this for 98% of priority one, and 99% of priority 2 calls. The Commission suggested the piloting of a single telephone number for urgent care services which had the potential to ensure fewer people attend the wrong services. The delay patients experienced, in general greater than in earlier times when the GP or his deputy immediately picked up the phone, was a possible cause of increased strain on A & E Departments.
Substitution of nurses for doctors in primary care might be cost effective and outcome studies suggested no great differences between the two types of practitioners in fields such as the follow up of patients with long term illnesses. Nevertheless the characteristics of GPs and nurses differed,. Doctors, said a BMJ editorial, needed to deal with uncertainties and take risks, while nurses were more attuned to following protocols and providing hands on care.
As a result of the devolution of health service management to the four nations of the UK, marked differences were emerging in hospital services. It was not just differences in the money available to spend. Policies led to different incentives. In England targets to improve performance, payment by results and the increasing emphasis on the provider/commissioner split and patient focus had driven change. Scotland had abolished the internal market and had integrated boards, purchasing and providing primary and secondary care, Wales did not separate purchasers and providers either and was looking at the Scottish model, and Northern Ireland continued with its integration of health and social services. Compared with the others, England had shorter waits in A and E in part because the reduction of waiting times seemed associated with a greater rise in attendances than elsewhere. Proportionately more patients were discharged rapidly, within a day of admission, in England.
The NHS Plan (2000) had announced a major building programme, largely funded by PFI, to replace and modernise the aging NHS estate, half of which dated from before 1948. Capital stock was now better. It was now down to 20 percent with 100 schemes completed and many others underway at a cost of £12 billion. Department of Health (and Scottish) guidance suggested that new hospital wards should contain at least 50% of accommodation in single rooms. Maidstone and Tunbridge Wells trust replaced its ageing Pembury Hospital with the NHS's first all single room acute hospital, a 230 million PFI scheme to open in 2011. The new hospital provided all patients - except those in the special care baby unit - with their own en suite room. This was welcomed by patients' organisations and might help to reduce cross infection rates.
Independent sector treatment centres were failing to provide value for money. Though paid above tariff levels, few seemed likely to deliver more than 90% of the services for which they were paid during the first 5 years of the contracts. Some waiting list work from NHS units was sometimes transferred, but it seemed unlikely that all ISTCs would justify renewal of contracts or succeed when payments moved to tariff. levels. The Department agreed to meet the buy-back costs of residual assets were a centre to close.
The financial crisis made credit hard to obtain and this affected PFI. In 2009 the Treasury announced plans to lend to recession hit PFI schemes The buildings and facilities of some 15 independent treatment centres were purchased by the NHS. Costing some £200 million, some contracts with the private sector might be renewed, the NHS acting as landlord. Some schemes in Nottingham and Merseyside would cost £40 million each.
Of 22 hospital schemes planned in England in 2007, two years later only eleven were being pursued, because of the credit crunch and because PFI was now recognised to lock hospitals into decades of fixed overheads, just when policy was to encourage a shift to care outside the hospital. In some cases up to 15% of trust revenue was predicated in this way. Now it was agreed that PFI schemes were far more expensive than paying from public funds, and in November 2011 n in depth review of PFI was announced, so that any future contracts were less of a drain on funds.
The Secretary of State thought the financial stability of many trusts was threatened by PFI but hospitals would not be closed for reasons of debt. Trusts with major debts from PFI included
St Helens and Knowsley (LIVERPOOL) £338m | Oxford Radcliffe and NOC £298m | Buckinghamshire Healthcare £92m | Mid Essex Hospital £163m |
| South London Healthcare £214m | Barts and the London £1,149m | West Middlesex University Hospital £60m | Maidstone and Tunbridge Wells £228m |
| University Hospitals Coventry and Warwickshire £379m | University Hospitals of North Staffordshire £274m | Mid Yorkshire Hospitals £311m | Sandwell and West Birmingham £377m Royal National Orthopaedic Hospital £61m |
| Wye Valley (HEREFORD) £ 64m | Dartford and Gravesham £94m | Walsall Hospitals £170m | |
| Barking, Havering and Redbridge £238m | North Cumbria University Hospitals £67m | North Middlesex £144m | |
| Worcester Acute Hospitals £87m | Portsmouth Hospitals £236m | North Bristol £430m | |
TOTAL £5,474m | |||
Over the previous decade the the need to base reconfiguration on clinical outcomes had become paramount. Looking to the future, there was uncertainty about who within the new system will drive forward strategic reconfiguration plans. An already complex and bureaucratic process seemed likely to become more complex and potentially confusing. The procedure was, in any case, complex and lengthy.
There were several drivers for reconfiguration. 
First there was patient safety and outcome. Fourteen senior doctors including College Presidents wrote to The Guardian in April 2010. "There has been a wealth of clinical evidence for many years that specialist clinical services, such as stroke, trauma and heart surgery, should be concentrated in fewer centres. This would allow the latest equipment to be sited with a critical mass of expert clinicians who regularly manage these challenging clinical problems, and are backed by the most up-to-date research. The greater volumes of patients mean doctors are better at spotting problems and treating them quickly. Survival and recovery rates would improve markedly with many lives saved. As techniques and technology have developed over recent years, speciality rather than proximity has become the key for patient safety. So increased patient safety and improved care must be the major drivers of any reconfiguration." Unpopular closures would be needed and simply condemning changes as bad and defending the status quo was not in patients' interests. Political rhetoric however suggested that public opinion should be a key factor in reconfiguration, and many people and most MPs felt the proximity of a service was more important than clinical outcomes. Conflict was inevitable but a few examples existed of delivering complex care in the home (domiciliary chemotherapy for cancer) or at a local hospital rather than a specialised centres (later care of stroke).
Reconfiguring a service did not necessarily mean reconfiguring the organisational structure of hospitals by merger. Cost was seen as a driver of merger but unfortunately, there was little evidence to guide health planners on the ‘optimal’ size of hospital services, not least because hospitals contain a collection of services, each with their own efficiency drivers. One of the most comprehensive assessments of hospital efficiency from the NHS Centre for Reviews and Dissemination (Aletras 1997 CRD Report no 8, part II. York: NHS Centre for Reviews and Dissemination, University of York.) suggested that optimal hospital size lay between 200 and 600 beds. Normand (1998 Journal of Public Health, vol 20, no 2, pp 129–32.) suggested that there is no good evidence to demonstrate that closing small hospitals saves money but that merger of particular services (e.g., intensive care, accident and emergency (A&E) services, cardiac surgery) could improve quality and save money. More important were workforce issues, the impossibility of providing complex staff skills 24/7 in more than a few places - but again, this might require service reconfiguration but not hospital merger.
Darzi's reports had stimulated action in the ten strategic health authorities with London a year in advance. Healthcare for London, a programme run by the London PCTs published substantive proposals in November 2008. Maintaining the district general hospital pattern of the 1960s was no longer relevant because of the development of community services (e.g. polyclinics) and the need for treatments such as for heart attacks and strokes to be centralised, it said that
"A local hospital, serving a population of around 250,000 would include a 24-hour accident and emergency (A&E) department, paediatric assessment unit, maternity unit, and provide inpatient emergency care alongside critical care services. In addition to other clinical services, it could also include a 24/7 polyclinic at its front door, treating non-urgent cases and providing direct access to diagnostics tests and outpatients. This will prevent many unnecessary trips to A&E departments. There is not a one-size fits all local hospital as the range of clinical services must be driven by local need."
It suggested how urgent or more routine illnesses might pass involve community services, a polyclinic, a local hospital or a major one. It produced financial models that indicated how the income of hospitals might change as the pattern of work altered. There was a belief that substantial savings could be made if care could be moved into the community. Polyclinics were seen as central to a reduction of the demand for, and the cost of, hospital services - particularly in London. The London School of Hygiene and Tropical Medicine was commissioned to undertake a two year evaluation of the early polyclinics but with a change in administration the polyclinic policy was largely forgotten..
Content of a local hospital | |
A&E department (24 hours) | Critical care facilities, level 3 (managing patients that require ventilation) |
Paediatric assessment unit | Outpatient services |
Urgent care centre (treating minor illness and injury) | Maternity services with a special care baby unit |
Emergency surgery for non-complex cases (12 to 16 hours a day e.g. abscesses, internal bleeding, bowel obstruction) | Diagnostics (including X-ray, ultrasound, CT scans) |
Medical cases requiring a hospital stay (e.g. pneumonia, heart failure, liver disease) | Pathology (blood tests, etc) |
Following the change of administration in 2011 Andrew Lansley slowed down the process of reconfiguration making it harder to rationalise services and save money. The NHS Chief Executive indicated four key tests to be met
This decision led to the resignation of the London SHA chairman and some of the non-executive directors, who were committed to proposals at an advanced stage. There was more than a year of limbo as action was delayed and money was spent keeping troubled hospitals afloat. Political expediency made it near impossible to close hospitals where necessary to reconfigure services, as in the case of Chase Farm where the same MP protesting its closure was vehement in his support for national change. The polyclinic concept died a death, although NHS management continued the development of resource centres for primary care where these were needed.
London was in advance in service reconfiguration, and London NHS (the Strategic Health Authority) hosted Healthcare for London, a10-year programme to transform healthcare and standards of health in the capital, established and paid for by the London Primary Care Trusts. This sought to improve PCT commissioning primarily be examining types of care where outcomes cold be improved by reorganising provision. In February 2009 it issued a consultative document making the case for 4 trauma units and 10 hyperacute stroke units in February 2009, ambulance services triaging patients. In July 2009 after consultation the PCTs agreed major service changes. London's Trauma system, went live in April 2010, critically injured patients being taken directly to one of four major trauma centres. The predominant type of injury is caused by a road traffic collision followed by stabbing injuries and falls from a height. Stroke services followed and cardiac services had already been reconfigured so patients went immediately to hospitals with 24 hour cardiac surgical facilities.
Four Major Trauma Centres | Eight Hyper Acute Stroke Units | Eight Cardiac units |
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Two to three years later regions followed London’s example by concentrating services into a smaller number of specialist units establishing networks of services for hyper-acute stroke care, major trauma and vascular surgery.
Reconfiguration by merger under financial pressures and risks to quality of care, made it imperative to consider south east London, where two whole hospital PFI sites (Bromley and Queen Elizabeth Hospital) had insuperable financial problems. It seemed impossible to make the savings needed without risking patient safety. In 2009, after a major exercise lasting five years (A Picture of Health), the scheme was approved to close emergency admissions with a large reduction in medical and acute bed capacity at the Queen Mary’s, Sidcup site. This affected 284 acute beds with a corresponding reduction in medical, nursing and non-clinical staff headcount. There were many lessons to be learned from the exercise; the ease of cost-savings was not one of them.
Paediatric cardiac surgery was examined after the problems in Bristol. In the 1970s when Guy's started heart surgery on children, the Department of Health doubted whether London needed a third unit in addition to the Brompton and Great Ormond Street. Nevertheless the unit was established and its results were good. A series of expert reviews over ten years had recommended that the eleven units carrying out heart surgery nationally on children should be reduced in number. A review was launched in 2008 by Sir Bruce Keogh, the NHS medical director. Some 3000 operations a year were carried some in rather small units. The evidence was that outcomes were better in larger and more active units. In a report published in February 2011 it was suggested that four should restrict themselves to paediatric cardiology, not surgery, Oxford, Leicester, Leeds and the Brompton. The Brompton, however, met all the criteria and had excellent outcomes, and took the proposals to judicial review where the consultation process was held to be flawed.
Networking specialist services was another option. Moorfield's Foundation Trust opened off-site units of which there were 11 by 2008. Hospitals would approach Moorfield's for assistance in maintaining a viable ophthalmic services, both sides benefiting. Clinical networks developed at a professional level with little management involvement.
Under the leadership of Professor Dame Sally Davies, the Department of Health's Director General of Research and Development and Chief Sci
entific Adviser and later CMO, continuing efforts were made to establish a consistent policy and framework to embed research within the NHS. The National Institute for Health Research worked in partnership with strategic health authorities and trusts, and NICE. Its goals were to establish the NHS as an internationally recognised centre for research excellence, attract, develop and retain the best research professionals to conduct people-based research, commission research focused on improving health and social care, strengthen and streamline systems for research management and governance, and act as sound custodians of public money for public good
Academic Health Science Centres, proven to be effective in the US for many years, had been supported in the Department of Health's Next Stages review. Following peer review by an international panel of experts the Health Secretary announced in 2009 the successful Academic Health Science Centres (AHSCs), designated for 5 years and subject to review, Cambridge University Health Partners, Imperial College, King's Health Partners, Manchester AHSC and UCL Partners. The concept was partnership between Universities and NHS organisations to take new discoveries and promote their application in the NHS and across the world. Such centres would have the potential to compete globally with established centres in the United States, Canada, Singapore, Sweden and the Netherlands: An international panel chaired by Sir Ian Kennedy selected the organisations allowing the government to identify the university and NHS partnerships best able to make the most of the synergies between research, education and health services to translate research into better care, increasing the speed at which research was taken "from bench to bedside and back again". Imperial College Health Care Trust, early in the field, thought that the UK was losing its position as a leader in biomedical research, in part for want of government support. Imperial thought the NHS had been poor in translating research into service and patient outcomes & lagged far behind other western countries. It saw academic health science centres as key to the future of the NHS, and that it was itself pre-eminent in this field, the only organisation in the UK likely to be able to compete on a global scale. The Medical Research Council had major commitments to all the centres. London centres received a third of MRC grants but Scotland as a whole got 13% and planned to cluster all its research and teaching hospitals into a single Health Science Centre.
| Links within this page |
Concern over the development of medical education internationally led to the establishment of a Commission by The Lancet, supported by the Bill & Melinda Gates Foundation, the Rockefeller Foundation, and the China Medical Board. The problem was stated as follows.
Medical schools in England (24), by region, (with hyperlinks)
Source: Medical Schools Council 2010
A growing number of medical schools offered a four-year fast track course for applicants who already have a degree. These courses has an important role to play in widening access routes into medicine - for example, for those who may not have aspired to a medical degree earlier or for people from a wider social and ethnic background. In 2009 the General Medical Council updated Tomorrow's Doctors, its guidance on the undergraduate medical curriculum. The British Medical Association also updated its 2004 study on medical school entry and considered that access to a professional career in the UK had become more and more inflexible over time. The majority of medical school students were still drawn from professional and managerial backgrounds. The age, ethnicity and gender profile of medical school students raised questions about the structure of medical education and about the future composition of the profession.
The costs for medical training (including related clinical placement costs allocated to the NHS) are high so any expansion of places is centrally planned and financed with co-operation between the BIS, DH and HEFCE to meet NHS needs. Intake to English medical schools increased from 3,749 in 1997-98 to 6,369 in the academic year 2010-2011. There was a total of 28,329 total medical (clinical and pre-clinical) full-time undergraduates in 2008-09. This resulted in an increase to the number of doctors graduating to around 5,684 in 2008-09.(source HEFCE and its website)
The additional costs that medical education imposed on teaching hospitals had been recognised for thirty years by the Service Increment for Teaching (SIFT). Significant for all medical schools and hospitals providing clinical placements, in the older medical schools SIFT could be considerable, £25 million to a teaching hospital. There had been little or no auditing of these sums and the money passing to the central teaching hospital could be substantially higher than that going to other hospitals with substantial teaching commitments. As part of the allocation system the NHS changed the way SIFT (and MADEL the levy for junior doctor training) worked, planning to set a sum for each student for each week in placement, to make the system more transparent and more fair across the country. The cost of a medical education to the students themselves was reviewed, and in 2011 it was decided that support would provide new students with a non-means tested grant of £1000, a means tested bursary of up to £6,000 varying on income, location and whether the student lived at home, and a reduced rate non-means-tested loan.
Changes were affecting service delivery. In August 2009 the European Working Time Directive came into force limiting the average hours worked by junior doctors to 48 per week. Concerns soon emerged including the running of the service, patient safety and the reduction in training experience. The Presidents of the Royal Colleges expressed anxiety about patient care as the teams that were rostered took over from each other. As doctor succeeded doctor on shift systems, patients had to repeat their histories. With restricted hours and and increased commitments to education rather than service, who kept the service running? Would competence be acquired under the new system? "Surgery is a body-contact sport, there is no question about it. You can’t be a good armchair surgeon". Bosk CL. Forgive and remember. University of Chicago Press, 1979 Nor did juniors always have the skills of their predecessors; when medical students no longer delivered babies, a new house officer who had never done so or stitched a tear was not a great help. Increasing concern by doctors and patients' organisations, led Andrew Lansley to make renegotiation of the directive a priority.
Responding to Sir John Tooke's inquiry into Modernising Medical Careers (MMC) the Department of Health responded and set up a new advisory body. NHS Medical Education England (MEE), was established in January 2009 to provide advice on training and education for doctors, dentists, health care scientists and pharmacists. It was a non departmental public body supported by a secretariat from the Department of Health. Not quite the body proposed by Sir John Took in his report, it would be concerned with postgraduate training and would relate to the GMC which took over the responsibilities of the Postgraduate Medical Education and Training Board in April 2010. The Secretary of State asked MME to review the effect of the European Working Time Directive on the training of junior doctors and the concern that the introduction of a 48-hour working week might have a detrimental effect. MEE asked Professor John Collins, visiting professor in Oxford University's Nuffield Department of Surgery to evaluate the medical foundation programme. The report in October 2010 showed it to have strengths and failings. Some trainees were asked to practise beyond their level of competence and without adequate supervision, placing patients at risk and giving the trainee the the impression that suboptimal care was condoned. Further, the system meant that more locums had to be employed to fill gaps at a cost of hundreds of millions of pounds.
Balancing the numbers in training and job opportunities had been a problem since the start of the NHS. The King's Fund published a detailed review of its history and problems in 2009. The aim of self sufficiency, to avoid the need of the NHS for overseas graduates, had been achieved by the increase in medical school entry, but medical unemployment once more became a possibility with the influx of overseas and European trained doctors and changes in clinical practice with nurses and others undertaking some traditional medical roles. (See 2010 Memorandum). Hospitals were increasingly employing nurse practitioners and staff grade (sub-consultant) doctors.
The longstanding aim of "a consultant led service" remained a distant prospect. More juniors were being employed as The European Working Time Directive came fully into force in 2009. While for 15 years the number of consultants had expanded at 4-5% annually this would not be enough not least because of financial constraints. The prospect of widespread use of a sub-consultant grade remained. Or because hospitals had previously received virtually all the salary of junior staff in training who required almost continuous supervision the money hospitals received in this way fell. With their shorter hours and educational commitments they might not represent value for money compared with other ways of providing care and trusts might not be so keen to have so many junior staff in the future
The increasing number of women entering the medical profession, set to form the majority within ten years, made it important to consider the effect on the NHS, and of the employment opportunities in the NHS for on women. The Royal College of Physicians published a report in 2009 on Women in Medicine - the future - the report stating that
However the preferences of women doctors, as with male doctors, might not match with career opportunities. With an increasing output from medical schools, the ability of doctors from overseas to compete on level terms with those trained in the UK, and the probability that the economic down-turn would limit the expansion of medical staffing in the NHS, the labour market for doctors looked set to become much harsher. BMJ 2009; 338: 1397
Links | Nurse education and staffing |
Nursing practice | |
Nursing administration |
In 2009 Gordon Brown established a Nursing Commission, chaired by Ann Keen MP, a Minister and a nurse, to review nursing. He said to the Royal College of Nursing "Nursing has become even more central to the future of both healthcare and all our fabric of social life in our country. Nurses are now performing operations ...are now prescribing .... running services,... as managers, nurse consultants, nurse practitioners, and ... we want nurses to be more involved and more central and more in control of what happens in the health service in the future." The Commission would "look at all the trends and all the changes and all the forces at work that are going to change our society and also change nursing in the years to come....and take the next steps to enhancing... and improving the status of nursing in our country for years to come."
Ann Keen (Department of Health) said, 37 years after the Briggs Report, that the Commission aimed to usher in a new era that locates nursing, midwifery and care issues in a central position in policymaking and management. "We will tell a new story about the future nurse and midwife, to create a modern, realistic but inspiring public image." Anne Marie Rafferty, Dean of Nursing and Midwifery, King’s College London, wrote "We need to raise the bar in nursing and midwifery education, practice and research, rooting out poor performance and standing up for standards". What was less clear whether the problems in nursing would be addressed by the Commission whose vision was. "that all nursing and midwifery staff fulfil their potential to help people who use NHS services, families and communities achieve the best possible health and well being......"
The report recommended protection of the title “nurse”, with only those registered by the Nursing and Midwifery Council (NMC) allowed to use it - even though much if not most nursing was now undertaken by healthcare assistants including such tasks as blood pressure checks. They, though not "nurses", should be more carefully regulated. It recommended a new pledge for all nurses and midwives stating their commitment to, and accountability for, high quality and continuously improving care. The report also stressed the importance of skilled midwifery to meet the challenges of a rising birth rate and persistent health inequalities. | Recommendations of Front Line Care
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In November 2007 the government and the Nursing and Midwifery Council (NMC) launched a Review of pre-registration nursing education to ensure that all nurses of the future were equipped to work in a modern healthcare environment. The consultation was based on a set of draft standards that set out what nursing students must demonstrate to be fit for practice at the point of registration. Some were standards for competence, the knowledge, skills and attitudes that graduate nurses needed to demonstrate at the point of registration. Others were standards for education that pre-registration nursing programmes must meet, relating to the teaching, learning and assessment of nursing students.
In 2009 government, in agreement with the NHS and the nursing professions, said that from 2011 all nursing students would undertake degree courses meeting new standards to be developed by the NMC, The Royal College of Nursing thought this as "an important and historic development." The intention was that a new syllabus would be introduced in 2012. Whether it would make nursing more or less attractive as a profession was hard to say. Few hospitals knew the proportion of their present nursing workforce with a degree though nationally about a quarter of nurses had. The huge NHS nursing force required a substantial proportion of each year's cohort of young people who had many other careers open to them. Recruitment was hard and many student nurses were in their late twenties. Project 2000 had aimed to professionalise nursing by encouraging greater academic involvement with university diploma courses and degree courses. It was increasingly criticised. The aims of nursing education that included the development of nurses as people with enquiring minds might conflict with the needs of the service and the requirement for compassionate and consistent care. University nursing courses varied significantly in their quality of their intakes and in the percentage finishing their course. At one London course only 8% completed training. NHS London, the SHA, launched new, higher-quality standards for the training, reduced the number of student places and chose eight preferred universities eligible for the £61 million training contracts with the aim of improving. the quality of care given to patients.
"Second tier nurses" (for example the old State Enrolled Nurses) had always been important, and might be more so in the future. For every 4 registered nurses with either a diploma or a degree (315,410 whole time equivalents in 2008) there was at least one health care assistant (HCA). When student nurses ceased to be part of the ward team, being 'supernumerary', and the abolition of the previous State Enrolled Nurse (SEN) training system, the gap was filled by HCAs - there were roughly 250,000 HCAs. A suggested ratio of 60% trained to 40% HCAs was sometimes reversed. Because HCAs were not registered, there was no central mechanism to deal with complaints against individuals. Many regretted the drive towards an all graduate workforce and the elimination of the SENs though some hospitals tried to train up good health care assistants for it was likely the demand for a second tier nurse would grow and much basic nursing would continue to fall on their shoulders.
A new generation of nurses arose who had far more technology to cope with, but who had perhaps spent too much time in the class room and seemed incapable of caring. Some hospitals withdrew nurse student placements from courses where the support to students was poor and some nursing colleges did not prepare staff to care for patients. In 2011 Peter Carter, chief executive of the Royal College of Nursing, said 'many new nurses arrive in hospital incapable of caring for patients because they have spent too much time in the classroom and not enough on the wards....the NHS was becoming increasingly reliant on unregulated and untrained healthcare assistants to do basic nursing.' (The Times 22 September 2011). A hospital in the Midlands explored whether it would be possible to bring back a hospital based nurse training school.
2004 | 2005 | 2006 | 2007 | 2008 |
15,862 | 16,146 | 16,848 | 17,270 | 17,538 |
Year | EU countries | Other countries | Other countries including EU |
2000/2001 | 1,291 | 8,403 | 9,694 |
2003/4 | 1030 | 14,122 | 15,152 |
2005/6 | 1,753 | 8,709 | 10,472 |
| 2007/8 | 1,872 | 2,309 | 4,191 |
With pressure on healthcare costs world-wide, senior nurses in the US wrote in the New England Journal of Medicine that it was essential to use all "health care providers" to the maximum of their capabilities. A growing shortage of primary care providers seemed to ensure that nurses (nurse practitioners) would ultimately be required to practice to their fullest capacity. Evidence from many studies indicated that services, such as wellness and prevention, diagnosis and management of many common uncomplicated acute illnesses, and management of chronic diseases such as diabetes could be provided by nurse practitioners at least as safely and effectively as by physicians. In many states independent practice and prescribing was permitted though there was opposition from some medical organisations.
In line with the attempt to measure the quality of care, stressed in the Darzi reports, Alan Johnson (the Health Secretary) suggested that in the nursing field treating patients with compassion, reducing the number of falls on wards and good hand-washing were the indicators that could be used to measure the quality of nursing care in the NHS. Safety could encompass indicatorssuch as the number of falls on a ward or infection rates. Compassionate care - whether patients are treated with compassion and whether they are fully kept informed of what is happening with their treatment - and effectiveness including the nutritional state of patients, minimisation of pain and results of hand-washing audits all needed to be monitored.
The 2009 Report from the Patients' Association, Patients not numbers, People not Statistics, showed how far the NHS had to go. In February 2011, the Health Service Ombudsman Ann Abraham reported that the NHS was failing to treat older people with care, compassion, dignity and respect. The report, Care and compassion?, based on the findings of ten independent investigations into complaints about NHS care for people over the age of 65 across England illuminated the gulf between the principles and values of the NHS Constitution and the reality of being an older person in the care of the NHS in England. How far was this a problem arising from the educational system?
In January 2012 David Cameron, the Prime Minister, unveiled a package of measures designed to tackle "the real problem" with standards of nursing care. Nurses would be told to do regular ward rounds and patients encouraged to carry out inspections as part of a drive to improve standards. Central to the plan was the Time to Care initiative, to improve efficiency and reduce paper work so that more time was spent with patients and a new quality forum would be established.
