health care technology in the united kingdom 8

Health CareTechnology in

the United Kingdomby Jackie Spiby 8

OVERVIEW OF THE UNITED KINGDOM

The United Kingdom, with a total population of 48.2 mil-lion in 1992, consists of four countries: England, Wales,Scotland, and Northern Ireland. Geographically, it con-sists of one large island and numerous smaller islands

covering 94,500 square miles. Although physically small, itsposition at the northwest coast of Europe has meant that it hasbeen able to maintain independence as an island and establishclose relationships with Europe and with North America. TheUnited Kingdom is essentially an industrial and trading nation;most of its working population is engaged in manufacturing andcommerce.

Government and Political StructureThe United Kingdom has a constitutional monarchy, and one sov-ereign body governs all four countries. The central governmenttakes its authority from the two-tiered Parliament (the House ofCommons and the House of Lords). The Prime Minister is theleader of the party with the majority of Members in the House ofCommons. Government departments and ministries are headedby Secretaries of State or Ministers, a subset of whom form theCabinet. All departments and ministries are led by individualsfrom the majority party in Parliament, so there is no separation ofthe executive and legislative branches of government. The de-partments and ministries also have permanent secretaries and oth-er executives who assist these Secretaries and Ministers.

Northern Ireland has regional independence but not a federalrelationship. Wales and Scotland have a degree of administrativedevolution that is of limited significance, although it has led to—some differences in how health services are organized. 241

.

242 I Health Care Technology and Its Assessment in Eight Countries

HEALTH STATUS OF THE POPULATIONDespite an increasing emphasis on prevention, theUnited Kingdom continues to compare poorly inhealth status to most of its European neighbors.Death rates for ischemic heart disease in Englandand Wales are just over 300 per 100,000 male pop-ulation aged 45 to 64; in contrast, West Germanyhas a rate of approximately 250 and France, 100.The rates of Scotland and Northern Ireland areeven higher than those of England at 450 and 400,respectively. This pattern is similar for breast can-cer.

The main causes of death in the United King-dom have remained stable, with the major burdenresulting from coronary heart disease (CHD) andcancer. Stroke is also a major health problem, ac-counting for 6 percent of health service spending.The health of newborns has been continually im-proving; the infant mortality rate fell from over 10per 1,000 live births in 1982 to 6.5 in 1992. Al-though the progress is encouraging, infant mortal-ity is still higher than it is in several Europeancountries, such as Sweden and Denmark.

Smoking remains the single most importantcause of preventable disease and premature deathin England, but some trends are improving. Adultsmoking rates are falling; in men, this is reflectedin a reduction in lung cancer. The epidemic inwomen (who have generally taken up smokingmore recently) is still rising. Rates of smokingamong children are not falling quickly enough,and efforts are being made to stop children fromsmoking.

Sexual health has also become a focus of na-tional and public health policy, with two primaryareas of concern. First is the rising level of concep-tions, especially among young teenagers. Secondis the increase in AIDS cases, mostly in andaround London and mainly homosexual men.However, the highest proportional rise in AIDScases is among heterosexuals.

Britain remains low in the level of expenditureon health services. In Europe it ranks only aboveGreece, Portugal, Spain, and Ireland in the level ofexpenditure per person.

National Targets for lmproving HealthA white paper entitled “The Health of the Nation,”published in 1992, set forth the government’sstrategy for improving health (18). It establishedthe following targets for CHD and stroke:

●

●

●

to reduce death rates for both CHD and strokein people under 65 by at least 40 percent by theyear 2000 (baseline 1990),to reduce the death rate for CHD in people aged65 to 74 by at least 30 percent by the year 2000(baseline 1990), andto reduce the death rate for stroke in people aged65 to 74 by at least 40 percent by the year 2000(baseline 1990).

For cancers:

to reduce the death rate from breast cancer in thepopulation,to reduce the incidence of invasive cervical can-cer by at least 20 percent by the year 2000(baseline 1990),to reduce the death rate for lung cancer in peopleunder the age of 75 by at least 30 percent formen and by at least 15 percent for women by2010 (baseline 1990), andto halve the annual increase in the incidence ofskin cancer by 2005.

For mental illness:

to improve significantly the health and socialfunctioning of mentally ill people,

● to reduce the overall suicide rate by at least 15percent by the year 2000 (baseline 1990), and

● to reduce the suicide rate of severely mentallyill people by at least 33 percent by the year 2000(baseline 2000).

For HIV/AIDS and sexual health:

to reduce the incidence of gonorrhea by at least20 percent by 1995 (baseline 1990) as an indi-cator of HIV/AIDS trends, andto reduce by at least 50 percent the rate of con-ceptions among the under- 16 population by theyear 2000 (baseline 1989).

Chapter 8 Health Care Technology in the United Kingdom 1243

For accidents:

■ to reduce the death rate for accidents amongchildren under 15 by at least 33 percent by 2005(baseline 1990),

■ to reduce the death rate for accidents amongyoung people aged 15 to 24 by at least 25 per-cent by 2005 (baseline 1990), and

■ to reduce the death rate for accidents amongpeople aged 65 and over by at least 33 percentby 2005 (baseline 1990).

The Patient’s CharterThe Patient’s Charter, published in 1991 by theDepartment of Health, articulates numerous rightsand standards, many of which have existed sincethe establishment of the National Health Service(NHS) (15). The Patient’s Charter provides ayardstick against which performance is based. Itgives patients the right to:

receive health care on the basis of clinical need,regardless of ability to pay;be registered with a general practitioner (GP);receive emergency medical care at any timethrough a GP or through the emergency ambu-lance service and hospital accident and emer-gency department;be referred to a consultant (acceptable to the pa-tient), when a GP deems this necessary and tobe referred for a second opinion if the patientand GP agree that this is desirable;be given a clear explanation of any treatmentproposed, including any risks and alternatives;have access to health records and know thatthose working for the NHS have a legal duty tokeep the contents confidential;choose whether to take part in medical researchor medical student training;be given detailed information on local healthservices, including quality standards and maxi-mum waiting times;

Source 0/0 of totalNational Exchequer (general taxation) 83

National Insurance Fund 14

Other sources (charges, land sales,etc.) 3

SOURCE C Ham, The NHS—A Guide /or Members and DirectorsO(Health Authorities and Trusts (Birmingham National Association of

Health Authorties and Trusts, 1993)

be guaranteed admission for treatment by a spe-cific date no later than two years from the daywhen the patient is placed on a waiting list; andhave any complaint about NHS services inves-tigated and receive a full, prompt, written replyfrom the chief executive or general manager.

One of the most important elements of the driveto improve the quality of care has been the policyof reducing waiting times for treatment. No pa-tients wait more than two years for treatment. In1993 a guarantee was introduced that no oneshould wait more than 18 months for a hip or kneereplacement or a cataract operation.

THE BRITISH HEALTH CARE SYSTEMIntroduced in 1948 by the Labor Party, the NHS isbased on the principle that everyone is entitled toany kind of medical treatment for any condition,free of charge. The NHS is not insurance-basedbut is funded primarily from general revenues (seetable 8-1 and figure 8-l).

There are nearly 980,000 staff employed in thedelivery of health services. In the fiscal year April1993 to March 1994, the total expenditure was setat 29.9 billion. 1

In England the Secretary of State for Health isresponsible to Parliament for the provision ofhealth services. In Scotland, Wales, and NorthernIreland, the respective secretaries of state assumethe responsibility. The relationship between the

1 Exchange rate in mid. 1994: $US 1.4410 1.00.

.


Department of Health Policy BoardNHS Management Executive

I

Special health Regional health NHSME outpostsauthorities authorities

District health / Family healthauthorities service authorities

I I - LDMUS (directly I Imanaged units) GPs GPFHs Trusts

II

Community health councils

SOURCE J Spiby, 1994

Department of Health and the NHS has its originin a series of acts, starting with the NationalHealth Services Act (1946) and consolidated inthe National Health Service Act (1977) and theNHS and Community Care Act (1990) (13,14).

EnglandIn England the secretary of state is assisted by theexecutive at the Department of Health. The PolicyBoard sets the NHS’S strategic direction. Chairedby the Secretary of State, it has these members:

health ministers,the Chief Executive of the NHS ManagementExecutive,the Permanent Secretary of the Department ofHealth,key individuals from outside the Department,including two regional chairpersons and topbusiness people, andthe Chief Medical Officer and Chief NursingOfficer.

The NHS Management Executive (NHSME) isresponsible for achieving the strategic goals set by

●

the Policy Board It is chaired by the Chief Execu-tive of the NHS, and its members, drawn fromNHS and business, lead various directorates. Boththe Secretary of State and the Chief Executive areaccountable for the prudent administration offunds to the Public Accounts Committee, whichoversees public expenditures of Parliament.

The Department of Health is staffed by perma-nent civil servants (of whom the permanent secre-tary is the head) and many other staff drawn fromwithin the ranks of health care professionals, par-ticularly doctors and nurses (about 4,500 staff inall). The Department provides:

■

●

advice to the Secretary of State and answers toquestions of Members of Parliament on all as-pects of the NHS, with a particular emphasis onpolitical considerations, anda range of professional advice to the Secretaryof State to guide policy development with ref-erence to national and international issues andtaking into account broad political consider-ations.

Department of Health officials and NHSMEstaff have both formal and informal arrangementsto ensure complementary activities. Day-to-dayactivity is managed by a range of agencies on theirbehalf (as shown in figure 8-1).

Wales, Scotland, and Northern IrelandResponsibility for health care in these three coun-tries rests with the Welsh Office, Scottish Office,and Northern Ireland Office, respectively. InWales the Secretary of State is assisted by theHealth and Personal Social Services Policy Boardand the Executive Committee. There are nine dis-trict health authorities and eight family health ser-vices authorities that increasingly work together.

In Scotland the Secretary of State operatesthrough the Scottish Home and Health Depart-ment and a Chief Executive. There are 15 healthboards responsible for family health services aswell as hospital and community services. InNorthern Ireland there are four health and socialservices boards covering social services as well ashealth care.


Health PolicyThe Department of Health is concerned with bothhealth and health care. Policies for improving thequality of health care are centered on the PatientCharter, which is part of a wider governmental ini-tiative to raise the standards of public services.The Department is also responsible for social careand seeks to improve services through policies setforth in a 1990 white paper entitled “Caring forPeople” (12). Local authorities are the lead agen-cies for community care (often used as a synonymfor social care) and are expected to work closelywith NHS authorities to ensure that a comprehen-sive range of services is available. One of the aimsof policy in this area is to shift the provision of ser-vices away from residential care to supportingpeople in their own homes.

The three key priorities for NHS in 1994 and1995 include:

implementing “The Health of the Nation, ”■ developing the Patient’s Charter at national and

local levels, and■ ensuring high-quality social care.

A fourth priority is to achieve greater healthcare efficiency and effectiveness through sounduse of resources and development of effective or-ganizations.

The Health Care Purchaser-ProviderRelationship

Since April 1991 and the introduction of the NHSand Community Care Act, there has been a philo-sophical and practical change in the way NHS ismanaged (14). Health authorities have been givenspecific responsibility for identifying their popu-lation’s health needs and for using public moneyto buy services under a specific contract so as tomeet those needs. Responsibility for providingservices rests with hospitals, GPs, and other pro-viders, such as community units. Providers cannow obtain funds only by contracting with pur-chasers.

The purchaser-provider separation has acceler-ated changes that were already under way and hasstimulated new changes, including:

greater accountability for service provision, asthe required service is more carefully specified;more emphasis on quality issues and on pa-tients’ rights, including the introduction of au-dit systems;more involvement of patients in specifying re-quirements; anda degree of competition between providers andthe use of outside agencies to provide certainservices, particularly in nonmedical areas.

The Purchasing ChainThe Regional Health Authority is a statutory bodyresponsible for strategic planning and monitoringof the activity of purchasers as well as for allocat-ing resources on the basis of an agreed-on formu-la. It also has a range of other enabling functions.

The District Health Authority (DHA) is a statu-tory body whose main function is to assess thehealth needs of the resident population and to pur-chase services to meet those needs. In England itskey priorities for 1993/94 were as follows:

■ to embrace a wider role as champions of healthin the local community,to develop strong alliances with other agencies(e.g., social service departments, FamilyHealth Service Authorities (FHSAs)), andto set an example as an employer by looking af-ter the health of its staff.

Top priorities for action include implementingthe “Health of the Nation,” ensuring high-qualityhealth and social care in partnership with local au-thorities, and developing the Patient’s Charter.

FHSAs are statutory authorities that continueto plan and manage the development of servicesprovided by GPs, family dentists. retail pharma-cists, and opticians, all of whom are independentpractitioners. In some places DHAs and FHSASare forming health commissions for joint purchas-ing. A formal merger of the two organizationswould require legislative change, which is ex-pected in 1996.

GP Fundholders are larger GP practices—those with 7,000 or more patients. They may be-come purchasers for a 1imited range of services(11 ). They may purchase all investigative ser-


vices, community nursing and community psy-chiatric nursing, some outpatient and therapeuticservices, and, most notably, a limited range of spe-cified acute procedures (costing no more than5,000).

DHAs and GP Fundholders place contractswith providers to deliver service, containing de-tails on the volume and quality of service to be de-livered for a price. DHAs and GP fundholdersmay place contracts where they choose. A contractmay be with any trust, private or voluntary provid-er, or other directly managed units; however, thesewill take into consideration historic patterns of re-ferral, access to services, and the wishes of GPsand patients. It is therefore the responsibility ofpurchasers to decide (within their financial alloca-tion) what services patients will receive.

TrustsTrusts are accountable to the Secretary of Stateand vary in the range of services they provide.Their performance is monitored (although notmanaged) by the NHSME via one of seven out-posts. Most outposts span two regions and are sep-arate from the regional function.

NHS trusts are self-governing units with theirown boards of directors, and they are operational-ly independent of the district health authorities.They make decisions on how to deliver service toachieve the highest quality. The trusts are free todetermine their own management structure, toemploy their own staff, and to set their own termsand conditions of service. They are also free to ac-quire and sell their own assets, to retain surpluses,and to borrow money subject to annual limits.

Each trust is required to prepare an annual busi-ness plan articulating its proposals for service de-velopment and capital investment, and showingsupport from purchasers for the development.Each trust also prepares and publishes an annualreport and accounts.

Contracts or Service AgreementsAll providers now work on contract. As the trustsare completely financially independent. they cansurvive only if they undertake procedures for

which they have a contract. (As these are not legal-ly binding, they are officially termed “serviceagreements,” but are commonly referred to as con-tracts.) If trusts undertake work for which theyhave no contract, they will not normally receivepayment. This is of particular importance in non-emergency surgery, where the maximum numberof operations is usually stipulated.

Most trusts obtain the majority of their workfrom the local DHA by which they were previous-ly managed. However, there is no rule stipulatinglocales from which their patients should come,and DHAs are free to place contracts where theylike. Certain historic patterns of patient referralare being broken down, particularly those involv-ing referrals to inner London teaching hospitalsfor relatively routine conditions. Providers (ifthey have extra capacity) may try to persuade dis-tant purchasers to buy their services, but cannot al-ways generate extra business because purchaserstend to have little uncommitted money.

NHS Management Reforms Plannedfor 1994 to 1996

A series of changes in the NHS management inEngland were announced in October 1993 by theSecretary of State for Health. Subject to consulta-tion, the new structure will be put into place by1996; some preliminary changes were due for im-plementation by April 1994 (21).

Initially, mergers will reduce the number ofRHAs from 14 to eight. Legislation will then beintroduced to abolish the RHAs altogether, replac-ing them with eight corresponding regional of-fices of the NHS Management Executive. Anotheraim is to enable DHAs and FHSAs to merge,creating stronger localquires legislation.

Provision of FundsPublic expenditures on

purchasers; this, too, re-

the NHS are determinedby the Public Expenditure Survey Committee, onwhich the NHS is represented by the Departmentof Health. The process begins each summer, andfinal figures for the next financial year are agreedon in the fall.


Patient group orservice type f million 0/0 of totalAcute care hospital 6,717 45Elderly 1,868 13

Other hospital 1,764 12

Mentally III 1,133 8

Maternity 816 6

Other community 927 6

Admlnistratlon 775 5

People with learningdisabilities 746 5

SOURCE C Ham, The NHS- A Guide for Members and Directors ofHealth Authorities and Trusts (Birmigham National Association ofHealth Authorities and Trusts, 1993)

In 1993/94 spending on the NHS was set at29.9 billion, or 12.25 percent of total govern-ment expenditures. Although this proportion hasincreased over the years, at 6 percent of the UnitedKingdom’s gross domestic product, health carestill accounts for a smaller part of the economythan it does in most developed countries. The pri-mary source of NHS funding is general taxation.

Salaries are the biggest single budgetary itemin a service with 980,000 staff members, includ-ing 500,000 nurses and midwives, 53,000 doctorsand dentists, 160,000 administrative and clericalstaff, and 145,000 ancillary workers (1992 fig-ures). Workers in primary care who are self-employed, including 30,000 GPs and 15,000dentists, are covered separately.

The NHS produces an annual report on expen-ditures. Table 8-2 shows the proportions of expen-ditures on hospital and community services bypatient group in 1990/91, indicating the prioritygiven to acute care and the importance of servicesfor the elderly.

Distribution of FundsSpending on health services in different parts ofthe country has historically been unequal. Fromthe mid- 1970s until 1991 a formula was used toredistribute resources gradually. The main change

has been the movement of resources from thesoutheast, particularly London, toward the northand, in each region, away from the large teachinghospitals and conurbations.

Funding is now allocated on the basis of the res-ident population of a health authority and not, asbefore, on the catchment population (i.e., patientswho come to be treated in the district hospitals).This is called resident/capitation-based funding.Health authorities are allocated resources on thebasis of a formula that takes into account the sizeand structure of the population, the pattern of ill-ness, the number of elderly people, and certaingeographical considerations. Consideration isnow being given to including so-called social de-privation factors, which will give some districtsmore money for growth and development.

Sources of Funds for ProvidersMost of the funds for activities in a provider unitcome from the Exchequer through contracts withDHAs and GP fundholders (11). Most capitalfunds are obtained as part of the business planningprocess and according to agreed-on external fi-nancing limits for each trust. Although trusts canin theory borrow money on the open market, theinterest rates are always higher than those avail-able from the central government. Partnershipswith private companies are encouraged for somecapital projects.

Private patients provide a small but importantpart of the income of units. For these patients,units are free to price services as they like. Theyare able to offer private patients treatment and fa-cilities in any part of the hospital but are increas-ingly developing separate rooms and sometimeswhole buildings for them. In 1992, private pa-tients generated 12,771 million in revenue.

Almost all hospitals have some charitabletrusts, usually accumulated over many years fromdonations. In long-established hospitals, particu-larly those with a famous name, these funds can besizable, and special trustees are usually appointedto administer them. Such funds area useful sourceof money for staff facilities, research, and equip-ment.


Public OrganizationsCommunity health councils (CHCS) are chargedwith representing the local community’s interestin the health service. They are an important sourceof public information and a channel for consulta-tion, representation, and complaint. There is usu-ally one CHC in each district, made up of 18 to 24lay members, a chairperson, and a paid officer (orsecretary).

The basic duty of each CHC is to review the op-eration of the health service in its district and makerecommendations on such matters as the Councilthinks fit. The CHC’S main functions are to con-sider complaints, visit NHS premises, serve as aforum for consultation on the planning of localhealth services, provide information on local ser-vices, and monitor the quality of services throughsurveys and other means.

Consumer interests are also represented bycommunity health councils in Wales. They arerepresented by the local health councils in Scot-land and by the health and social services councilsin Northern Ireland.

Although not directly concerned with individu-al patients, two influential bodies outside the NHScarry out audits of its performance:

The National Audit Office carries out studies,particularly ones concentrating on value formoney, which are regularly used by the PublicAccounts Committee when investigating theNHS’S performance.The Audit Commission, established in 1982,looks at local government activity. Its powerswere extended in 1990 to cover the NHS, andits governing body includes ministers. TheCommission appoints auditors to look at areasin which there is significant variation in perfor-mance. It attempts to spread good practice andhas produced a number of influential reports.

Impact of the ReformsOne of the key changes that has resulted from theseparation of purchaser and provider roles is thatGPs have started to work much more closely withthe DHAs. With GPs responsible for referring pa-

tients to hospitals and DHAs responsible for plac-ing contracts, it is essential that there be acontinuing dialogue between the DHAs and thephysicians on which hospital and communityhealth services should be purchased and wherecontracts should be placed.

As a result of this developing dialogue, serviceprovision has shifted toward primary care. Therehas also been a change in the balance of power be-tween GPs and hospital consultants, which hasforced hospital doctors to pay greater attention toGPs and to be more responsive to their demands.Consultants in some districts now hold their out-patient clinics in GP offices rather than in hospi-tals.

Some of the most significant changes resultingfrom the reforms have been pioneered by GPfundholders. The first wave of fundholders in-cluded many of the best-organized GP practices,and these GPs have used their new powers to im-prove the services they deliver. The result has beena shift in favor of GPs and greater accountabilityof hospital doctors to purchasers.

The NHS trusts have also used their freedom toimprove the quality of care, including steps to re-duce waiting times, provide greater flexibility inclinic hours, and improve arrangements for pa-tient appointments. Of particular importance hasbeen the ability of trusts to run their own affairsand make decisions more quickly than in the past.

No national blueprint for reform has been setforth by the Department of Health and to a largeextent implementation has been characterized by“learning by doing.” In this sense the develop-ment of NHS as an organization depends on actualimplementation experience and cannot be pre-dicted in advance. This observation applies partic-ularly to the evolution of the internal market.There was little competition in the first year of thereforms, as the main emphasis was on laying thebasic building blocks of change. In 1992/93 pur-chasers were more active in switching to altern-ative providers, and such switches caused financialproblems in a number of hospitals, especially inLondon. (The future of health services in Londonhas been the subject of a special inquiry (45).)


It is not clear how ministers will respond to theemergence of losers in the internal market. Thelogic of the reforms is that competitive incentivesshould be used to reward providers who are effi-cient and to penalize those who are not. The diffi-culty with this approach is that the NHS’Sfounding principles, such as access and equity,may be undermined if people have to travel furtherfor treatment as a result of the closure of hospitalsthat fail to compete successfully. Ensuring thatpeople who have the poorest health receive thetreatment they need remains a continuing chal-lenge. For this reason the market must be managedto diminish the risk of gaps in service provision orunplanned interventions.

CONTROLLING HEALTH CARETECHNOLOGYThere is no overriding legislation to control thepurchase and use of health care technology in theUnited Kingdom. The regions, districts, andFHSAS are allocated budgets annually. The re-gions maintain some control over major capitalschemes or purchases, whereas the trusts and GPscontrol decisions at the local level—in collabora-tion, at varying levels, with the DHAs andFHSAS. The Department of Health is often in-volved in the development of new technologies atan early stage, but its involvement is variable, as isits level of control. Pharmaceuticals are the onlyarea in which there is a clear process for control-ling introduction; otherwise, the mechanisms ofcontrol vary considerably.

In recent years the need to control the introduc-tion of new technologies has become more widelyappreciated. This is due mainly to the fact that thehealth care budget is already under heavy pressurefrom the growing elderly population, and also toan increased awareness of the need to ensure thathealth care technology is effective and offers justi-fiable additional health gains and minimal sideeffects.

Development of a National PolicyIn 1988 the House of Lords Select Committee onScience and Technology. in its “Priorities in Med-

ical Research,” stated that coherent arrangementswere lacking by which the NHS could articulateits research needs and ensure that the benefits ofresearch were translated systematically and effec-tively into service. The Committee was particular-ly critical of the way in which public healthresearch and operational research (i.e., research onthe organization and management of health ser-vices) had been relatively neglected. It suggesteda marked increase in funding for this area.

In response the government created a seniorpost of director of research and development tohead the NHS Research and Development Divi-sion and to sit on the NHSME ( 16). A research anddevelopment strategy was launched in April 1991as the first stage in creating an R&D program inthe NHS. This R&D program emphasizes evalua-tion of the quality, effectiveness, and cost of healthcare methods and research into the delivery andcontent of health care. It also seeks to influencebiomedical research not only by expecting NHSpriorities to be taken into account when planningfuture programs but also by expecting the practi-cal implications of major research discoveries tobe anticipated early.

To ensure integration of R&D with NHS com-missioning, the regions were given responsibilityto commission and manage regional R&D pro-grams and also to help ensure that 1 ) the results ofgood research are used to full effect, and 2) the re-gions promote a dialogue between the local re-search community and purchasers. During 1992the regions developed their own R&D plans andappointed staff to oversee their programs. In thefirst round, the staff were mainly clinicians; there-fore, some of the impact on NHS activity (as op-posed to biomedical research) has been lost.However, to ensure that the strategy is close toNHS’S R&D needs, a Central Research and De-velopment Committee (CRDC) was set up to re-view R&D of relevance to NHS’S work and toidentify areas where further work would be of val-ue. The committee brings together senior NhSmanagers, leading research workers from univer-sities and elsewhere, lay members, and otherswith experience in industry. The work that it iden-tifies as a priority will either be funded centrally or


by the regional health authorities and postgradu-ate hospitals.

The lack of real controls on medical technologyand the role of technology assessment became ap-parent during the development of the R&D strate-gy. Early on, the Department of Health’s directorof R&D set up a health technology group to pre-pare a report on methods for assessing the effectsof health technologies. Among the main points ofthe report are:

the range of possible outcome measures bywhich health technology effects might be as-sessed should always be considered explicitly;existing evidence on the effects of health tech-nologies should be reviewed systematicallyand the results disseminated in forms that awide range of decisionmakers, including pa-tients, can understand. If the evidence is strong,means should be used to ensure that it in-fluences practice;there should be a systematic information sys-tem for disseminating the results of technologyassessments;every effort should be made to assess the effectsof new technologies before decisions are madeon whether they should be used within thehealth service;multidisciplinary research centers, each focus-ing on a priority area, should be established toassess the effects of health technologies; andthere should be training and a career structurefor those who wish to specialize in technologyassessment (17).

The report was considered by the CRDC, and inFebruary 1993 a Standing Group on HealthTechnology was established. This StandingGroup established six advisory panels to considerprimary and community care; acute care; pharma-ceuticals; diagnostic and imaging technology;population screening; and R&D methods. Fol-lowing consultation with NHS and other inter-ested bodies, each panel put together a list of itstop 20 priorities, which was published in Decem-ber 1993.

The Standing Group’s key tasks are to:

identify and rank technologies in need of as-sessment;identify and rank the need for R&D of technolo-gy assessment methods, especially in caseswhere diffusion of a technology must be con-trolled until more information becomes avail-able; andidentify emerging technologies likely to havemajor implications for the NHS.

The R&D strategy, the Standing Group andassociated infrastructures are major steps toward arigorous national process. To date, however,technology assessment has been seen mainly as asource for R&D monies rather than a means offinding answers that will actually inform clini-cians or managers. To address the ongoing needfor practical information for short-term use, threeunits have been set up to handle existing researchdata. The Cochrane Centre was established in Ox-ford to undertake systematic analysis of clinicaltrials; a center in York will commission expert re-search reviews; and health care effectiveness bul-letins, produced from Leeds, are already offeringuseful overviews of technology assessments (38).The York unit will also concentrate on the system-atic transfer of this and other research informationto users and will help develop skills for transfer-ring research information to decisionmakers.

Figure 8-2 shows how a technology assessmentproblem is “managed” such that useful informa-tion is provided to NHS.

Regulation of PharmaceuticalsThe pharmaceutical industry, often depicted as abastion of the free market, is in fact heavily regu-lated. A maze of rules has been created by sepa-rate, often isolated, government departments. Thefinance division pursues policies separate fromthose of its pharmaceutical price regulationscheme (PPRS) colleagues and often, it seems,with little liaison with officials of the Departmentof Trade and Industry, which pursues its own anti-trust and balance of trade goals.


I Problem I

IFilter:

known solutions to problem

Filter:solutions sought through

research in progress

Problems presented toMedical Research Council,

Economic and Social ResearchCouncil, charities

Research commissioned byDepartment of Health,

NHS, or both

I New R&D work I

I

I Information transfer I

Information vehicles

E&cl 9 “Contracts Patient information

I Routine use

1

Measurement of results

SOURCE M Peckham, 1994, in R Smith, “Filling the Lacuna Between Research and Practice An Interview with Michael Peckham, ” Br. Med. J.3071403-1409, 1993


Safety and EfficacyIn the United Kingdom, voluntary regulations forpharmaceuticals emerged in the 1950s. Followingthe failure to prevent the teratogenic effects of tha-lidomide taken by pregnant women in the early1960s, the 1968 Medicines Act created the Com-mittee on the Safety of Medicine (CSM), whichadvises on the safety, quality, and efficacy of newmedicines. This act also established the Commit-tee on the Review of Medicines (CRM) to reviewthe safety, quality, and efficacy of existing prod-ucts. A licensing system was created to regulateclinical trials, marketing, the manufacture and dis-tribution of products, and advertising and promo-tion.

The process of licensing a New Chemical Enti-ty (NCE) has become long and expensive. Animaltoxicity tests, if acceptable, are followed by clini-cal trials on human subjects. The company canthen apply for a product license, without which theNCE cannot be marketed. This process may take10 to 12 years from the time that the compound ispatented.

If a new drug has potential breakthrough effects(e.g., for treating AIDS), a fast-track route can befound; however, this is rare.

Patent legislation rewards producers of innova-tive drugs by giving them monopoly power; with-out this incentive, R&D investment wouldprobably be reduced. The legislation governingNCES has eroded patent protection and reducedthe duration of monopoly power (hence profits).In addition, the licensing rules raise costs, and to-gether these factors may well diminish drug com-panies’ R&D investments.

Regulating Prices and ProfitsSince 1957 the prices and profits of the U.K. phar-maceutical industry have been regulated by thegovernment and the PPRS. Each year, the Depart-ment of Health assesses firms’ profitability inrelation to targets set to ensure that costs, profits,and prices are reasonable—that is, in the range of17to21 percent. If a firm’s return exceeds this fig-ure, it may be required to repay money to the De-partment. If returns are less, applications can be

made for a price increase. The Department alsolimits aggregate expenditures on sales promotionto 9 percent of total sales revenue.

PPRS is a voluntary agreement that the Houseof Commons Public Accounts Committee re-views irregularly and for which there is no otherpublic review. The scheme is directly affected bycost containment mechanisms. If cost-reducingactivities are successful within NHS, a firm maybe allowed a price rise via PPRS.

User ChargesPrescription charges were abolished in 1965 butreintroduced in 1968 (with extensive exemp-tions). Since then the charge per item has risenfrom 13 per item in 1968 to 4.75 in 1994. Thisis well over five times the general price level in-crease; however, the revenue obtained has de-creased as a result of increasing numbers of peoplewho are exempted from payment (52 percent wereexempt in 1969, 85 percent in 1991).

Generic PrescribingPrescribing of generic alternatives to brand-namedrugs becomes possible when an NCE goes out ofpatent. Generic prescribing is strongly encour-aged, and recently several campaigns and officialreports have put pressure on GPs and FHSAS toincrease the level of generic prescribing. In 1979,approximately 29 percent of prescriptions weregeneric; this had risen to 40 percent by 1990, and atarget of at least 50 percent has been set in manyregions. An educational program for the generalpublic is under way to explain why the gover-nment promotes generic prescribing.

Limited ListIn 1985 the range of drugs prescribable underNHS was limited by the Department of Health. Nolonger prescribable were medicines for whichover-the-counter alternatives were widely avail-able. The government claimed that in the firstyear, 275 million was saved by this mechanism.The aim of the limited list is to force consumers ofall ages to pay for some medicines and to ensurethat expensive drugs are not prescribed unneces-


sarily. The limited list was extended in 1994 to in-clude drugs such as those for hay fever andduodenal ulcers.

Prescribing Analysis and Cost Data (PACT)PACT and similar systems used in Scotland andNorthern Ireland are an attempt by the Departmentof Health to disseminate information on prescrib-ing behavior to GPs to increase their awareness ofcosts. The feedback system began in 1988; sincethen, there have been some changes in prescribingpatterns, although it is difficult to know whetherthey are due to PACT. Capacity to use the data hasbeen increasing; all FHSAS are directly on line tothe Prescription Pricing Authority, which down-loads PACT data monthly.

Indicative Prescribing BudgetsThe indicative prescribing scheme, introduced in1991, aims to build on the PACT system to im-prove prescribing and reduce drug expenditures(10). RHAs receive an annual block allocation tocover the cost of all prescriptions dispensed with-in their FHSAS. Initial allocations reflected histor-ical spending patterns but are increasingly movingtoward a weighted cavitation basis. FHSAS thenset indicative prescribing amounts for each GPpractice based on factors such as existing costs,number and age of patients, local social and epide-miological factors, morbidity, and special circum-stances. If a GP overspends the indicative budget,the FHSA medical and/or pharmaceutical adviseroffers advice on how costs might be reduced. Thebudget is not a firm cap however, and FSHAS haveno executive powers to penalize GPs. In the wakeof a recent Audit Commission report, it is antici-pated that the budgets soon will be cash limited.

Regulation of Medical EquipmentIn comparison with pharmaceuticals, the controlof medical equipment is minimal. In the Depart-ment of Health a fairly complex set of machinerysupports and tracks new developments and ad-vises scientific and supplies officers; this is not,however, the same as control. In certain extremesituations, a warning hazard note can be produced

by the Department, and particular equipment is re-moved. The scientific and technical division ofthe Department is mainly responsible for produc-ing this information. Its work covers technicalquality (i.e., whether the equipment does what themanufacturer says it will do), reliability, and me-chanical and electrical safety for the patient andoperator. This work rarely includes analysis ofcost-effectiveness or an understanding of the im-pact of the equipment on organizations.

The Department of Health also regulates theintroduction of equipment through its role in fi-nancing high-cost technology. These so-calledpump-priming funds are used to support an indus-try introducing equipment that is deemed neces-sary by the NHS. Two or three items might bepurchased to help the sales take off, especially ifthe Department has previously supported this de-velopment through its R&D program.

In the past there was a clear procedure for thepurchase of new equipment: it was purchased withfunds from a regional capital budget againstwhich districts bid for their local hospitals. Manyregions devolved a portion of this budget to dis-tricts in order to purchase smaller pieces of equip-ment.

Eighty percent of this equipment budget is usu-ally required for replacement purposes, and onlythe remainder is available for new developments.The key decisionmakers in both the district andthe region are managers and clinical advisorycommittees. The system tends to be somewhat ar-bitrary and is frequently based on a “he whoshouts loudest” principle rather than a systematicanalysis of need.

With the introduction of the split between pur-chasers and providers, the relationship for capitaldevelopment is purely a matter to be worked outbetween the provider and region or NSME out-post. The use of non-NHS monies for capital is ex-pected to extend as the trusts become morefamiliar with the use of private financing mecha-nisms.

At present, trusts make bids to the region oroutposts in their annual business plans for specificcapital development. The control of large piecesof equipment and the implications of developing


new technology have become more apparent toproviders as these costs are included in their fullcosts and called “capital charges.” These chargesare passed on to the purchasers; institutions withexcessive building capital or equipment thus havehigher costs within their contracts.

NHS Supplies AuthorityIn 1991 the Department of Health reversed its pre-vious policy of devolving the purchase of medicalsupplies (ranging from catering to expensivescientific equipment) and established a centralNHS Supplies Authority. This change resultedfrom a report by the National Audit Office thatwas critical of NHS buying. It stated that the con-siderable bulk buying power of the NHS was notbeing fully utilized because of lack of coordina-tion and that many opportunities for more cost-ef-fective purchasing were being missed. The mainfocus of the report was more cost-effective buy-ing.

The Supplies Authority provides a central,coordinated policy for buying supplies. It has sixdivisions, with the national headquarters concen-trating on key commodities such as food con-tracts, medical and surgical items, and x-rayequipment. The Authority also undertakes re-search into market requirements and has a smallR&D program. This new development is rather atodds, however, with the establishment of trustsand the independence of providers. At present, itis expected that the trusts will be encouraged, butnot required, to use the purchasing power of theAuthority.

Control of Provider LocationsIn the past the Department of Health and theRHAs had strong control over the placement ofproviders through a regional planning tier or spe-cific, centrally promulgated regulations, concer-ning where GP practices could be sited. With theintroduction of the internal market, it was antici-pated that this regulatory planning function wouldbe removed, and placement of providers would besubject to market forces.

It has become clear, however, that at present thegovernment is uncomfortable with allowing trusthospitals to close merely because of marketforces. The mode of control or “market manage-ment” is still under discussion. Theoretically, ifpurchasers do not place a sufficient number ofcontracts with a provider to ensure its continuedexistence that provider should close. In reality,while some are closing or unifying with adjacentunits, no major hospital has yet closed.

In central London the government has deter-mined that it is unhappy letting the market controlthe siting of providers. It has chosen to set up acentral review body (the Tomlinson Review) thathas clearly identified where teaching hospitalsshould be merged or where specific providersshould close. These decisions have been much de-bated, and considerable lobbying has been under-taken. Some, though not all decisions have beenoverturned by the Secretary of State.

Regulating the Placement of ServicesThe role of districts in purchasing health carebased on assessed needs provides a major impetusfor technology assessment. For the first time,managers and public health physicians are work-ing together to assess the literature on effective-ness of health care procedures, includingcost-effectiveness.

The Department of Health has responded bycommissioning a series of bulletins on the effec-tiveness of health service interventions for deci-sionmakers; the first editions were published inJanuary 1992. These bulletins are specifically ori-ented toward health authorities rather than clini-cians.

The need to purchase effective health carepackages is also promoting interest in serviceevaluation, and research on local health services isincreasing rapidly. At present the main effect ofdistricts as purchasers is to reduce support for ex-pensive technologies with little proven effective-ness. This potential conflict between teachinghospitals and their clinicians and the purchasershas not been resolved, nor have explicit mecha-nisms of control been established.


Districts are increasingly including GPs in thisprocess as part of the advisory mechanism for pur-chasing services. This is a new role for GPs; somerelish it, but others find it unacceptable either be-cause they do not consider it is a good use of theirtime or because they have qualms about taking oneven greater responsibility y for what they considerto be management.

The role of the DHAs in determining where re-sources are allocated has become increasingly ex-plicit, as they have lost their direct managementrole. This explicitness, inevitable with the NHSreforms, is proving difficult politically; previous-ly, the long waiting list dealt implicitly with ex-cess demand. Consumer expectations have alsorisen, and the conflicts between resource avail-ability and patient need and demand are makingthe role of the DHA purchasers increasingly diffi-cult.

Control of UseWithin the new purchaser/provider system, use isdetermined through the contract between theDHAs and their providers. The level of refinementof this contract is very limited at present, and uti-lization is measured by numbers of consultant epi-sodes, which means that the emphasis is oninpatient activity and events rather than on indi-vidual patients. This is obviously not adequate,and better information systems are being devel-oped (though not quickly enough for current re-quirements).

On the whole, most districts are signing con-tracts with providers which aim to reduce the levelof activity in acute hospitals, either because oflimited funds or because of policies that aim toshift activity from hospitals to the community.Demand is continuing to rise, and hospitals areseeing an annual increase of 2 to 5 percent in activ-ity. This conflict between increased patient de-mand and reduction of activity levels in purchasercontracts can be seen clearly in districts in thesouth of England, where budgets on the whole arebeing decreased. In some hospitals, only urgentwork is done near the end of the financial year toensure that activity is kept within the agreed con-

tract and that budgets are not exceeded. Such re-strictions are not acceptable to the government,however, and providers are being required to pacetheir activities throughout the year.

Utilization and Quality ControlThe contracts set with providers by DHAs covernot only activity and finance but also aim to iden-tify key quality measures. At present, the mainemphasis in contracting is on activity and money.(This is due to the newness of the system ratherthan to a policy decision.) The level of detail andtype of quality measures to be identified by thedistricts still are being developed. Clearly, the em-phasis should be on outcome measures and ex-pectations for the health of the population. Asthese are frequently difficult to identify and mea-sure, process and structural measures probablywill be used.

The Role of the Private Sector andConsumers

The private sector accounts for a small percentageof health care spending in the United Kingdom,most of which is funded through health insurancecompanies. There are clear rules as to whichtechnologies are paid for under which policies; forexample, cosmetic plastic surgery is not reimburs-able. There is no published information on howthese guidelines are determined. With increasingmedical care costs, insurance companies areintroducing cheaper policies that limit what can beprovided.

A major part of the NHS reforms was a com-mitment to the role of the consumer in decision-making. The 1991 Patient’s Charter sets outclearly, for the first time, the public’s right tohealth care and to national and local charter stan-dards, which the government intends to seeachieved. This greater emphasis on the role of theconsumer will no doubt increase actual patientquestioning of medical practice, as well as interestin consumers’ views by policy makers and others.The growing role of the consumer in technologyassessment can be glimpsed in the inclusion ofconsumers in the planning of a few major random-


ized controlled trials (e.g., trial of chorionic villussampling).

HEALTH CARE TECHNOLOGYASSESSMENTThe United Kingdom has along history in some ofthe methods of technology assessment, such asrandomized controlled trials and the developmentof health economics, but this has not been in acoordinated policy context. Interest in technologyassessment has been slowly increasing because ofpressures resulting from the costs of new technol-ogies, increasing recognition of the potential dan-gers of new developments, and perceptions ofmore organized activity abroad. Originally, themain pressure for technology assessment camefrom those parts of the research community under-taking this work, including the King’s Fund (acharitable health policy organization), healtheconomists, the media, and some parts of the med-ical profession. More recently, however, pressurehas come from NHS managers (including doc-tors), public health medicine, and purchasing au-thorities.

Raised within the context of the national R&Dstrategy, research dissemination and organiza-tional issues (e.g., linkages between research andclinical practice) have become very significant.The report of the Standing Group also outlined theneed for a career structure to encourage individu-als in technology assessment. Problems in recruit-ing and retaining personnel had been a particularproblem in health service research. The report ar-gued for health technology assessment to befunded from public monies and coordinated by thenational R&D strategy; to this end the fundingmechanism itself was said to need clarification.The report also identified problems in organizingmulticenter studies of major diseases. Finally, thereport identified problems in undertaking properrandomized assessments resulting from litigationwith regard to informed consent, corporate indem-nity, and costs of treatment. These obstacles,stated the report, must be acknowledged more ex-plicitly and overcome. The full impact of theStanding Group has yet to be fully felt, but it is

clear that the importance and relevance of technol-ogy assessment to the NHS has been firmly estab-lished. Outside the research community, this is notyet the case.

Technology Assessment Entities

The Medical Research Council (MRC) and theStanding Medical Advisory CommitteesThe Medical Research Council plays a key role inBritish medical research activities. It has beendominated by biomedical research and has beenless interested in health services research or in thewider issues related to medical technology. Afterthe publication of the House of Lords report, theappointment of a Director of Research and Devel-opment at the Department of Health, and a newSecretary at the MRC, change has accelerated.There appears to be a more positive attitude to-ward health services research and applied clinicalresearch, as evidenced by the new board structure,which includes a fourth board for health servicesresearch, public health, and epidemiology.

Relations between the MRC and the Depart-ment are governed by a concordat that acknowl-edges the strong role of the latter in health servicesresearch. A report is also being considered by theMRC board that proposes that the MRC take amore active role in evaluating procedures (includ-ing consideration of economic, quality-of-life,and psycho-social issues).

Questions on such developments as neural tubedefect screening or heart transplants are likely toarise in discussions between the Chief MedicalOfficer (CMO) and the medical profession. TheCMO may then seek advice from the StandingMedical Advisory Committee (SMAC). For ma-jor issues a specialist SMAC subcommittee maybe set up on an ad hoc basis to study the subject.Once the subcommittee has prepared a report andits recommendations are accepted by SMAC, aHealth Circular on the subject may be sent out toNHS management. Such circulars provide adviceon whether, to what degree, and how a serviceshould be provided. In the final analysis, however,decisions are made by regions and districts. In


some circumstances, such as heart transplants,some central funds may be provided, but this oc-curs only for quite exceptional developments.

The Audit CommissionThe Audit Commission is an independent bodythat audits the public sector. It has recently devel-oped its work in health matters and has reviewedservices such as those for day surgery, AIDS pre-vention, and bed utilization. Because it has accessto all health authorities, it could potentially have aconsiderable impact on the use of medicaltechnology.

King’s FundOne of the main proponents of technology assess-ment in Great Britain during the 1980s was theKing’s Fund, both behind the scenes and in the de-velopment of the U.K. Consensus DevelopmentProgramme. The latter has now ceased, but as dis-tricts and RHAs authorities have come to recog-nize their need for assessment data, the methodhas been adapted to local circumstances.

Clinical Standards Advisory GroupThe Clinical Standards Advisory Group (CSAG)was established in 1991 as part of the NHS Act toadvise the health ministers or health care bodieson standards of clinical care, and access and avail-ability of services to NHS patients. Most of themembers are nominated by the Royal Collegesand faculties relating to medicine, nursing anddentistry, although the CSAG is funded by the De-partment of Health. Its initial work has coveredthe following:

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access to and availability of selected NHS spe-cialist services,clinical standards for women in normal labor,standards of clinical care for patients admittedto hospital urgently or as emergencies. andstandards of care for people with diabetes.

This body represents anew venture in develop-ing and assessing clinical standards, and its suc-cess is still not assured-especially as it isadvisory rather than mandatory. It produced a se-ries of reports in March 1993 covering neonatalintensive care, cystic fibrosis, childhood leuke-mia, coronary artery bypass grafting, and angio-plasty. There was no consistency in the methods oruse of objective data in these reports. Their effectsare difficult to assess but generally appear limited(4,5,6,7).

Medical AuditA key part of the NHS reforms is encouraging alldoctors to undertake medical audit, which in-cludes the “systematic, critical analysis of qualityof medical care and treatment, the use of re-sources, and the resulting outcome and quality oflife for the patient.” New monies have been re-leased by the Department of Health for the devel-opment of medical audit, and in the fourth year ofthis initiative, a large number of clinicians are in-volved at some 1evel. Much of the activity is fo-cused on collecting data, but in some centersclinicians are now looking more critically at theirwork and judging it against agreed-on standards.This initiative, along with management changesthat are encouraging doctors to be more involvedin management issues, is forcing the professionsto consider evidence on the costs and effective-ness of clinical procedures.


TREATMENTS FOR CORONARYARTERY DISEASECoronary artery bypass grafting (CABG) was de-veloped in the United States in the late 1960s butwas not introduced in the United Kingdom untilthe mid-1 970s, probably because of financialconstraints. Percutaneous transluminal coronaryangioplasty (PTCA) was introduced in the early1980s.

Because CABG requires relatively expensiveequipment, it developed at the teaching institu-tions where capital monies were more accessibleand medical staff sought to be at the forefront ofmedical expertise. The most well-endowed re-gions tended to be those in the London area; theyhad the greatest number of teaching and postgrad-uate institutions.

By 1982 the CABG rate was 107 per millionpopulation. This overall rate disguised a 12-foldvariation among regions, from 21 to 263 per mil-lion. The rate of CABG rose steadily to 212 permillion in 1986 and 278 per million in 1990. Theextent of inter-regional difference fell, but thereremained a fivefold difference: 97 to 466 per mil-lion in 1990. The most active regions were consis-tently in the southeast and in areas with aconcentration of teaching hospitals. This increasein surgery was accompanied by a slow increase incardiothoracic surgeons.

The differences among regions are mirrored byvariation in utilization rates among districts with-in regions, most marked at the earlier stages of dif-fusion. Not surprisingly, uptake has been higher indistricts with hospitals that provide the service, orwhere a local cardiologist is associated with asurgical unit, and not necessarily those with thegreatest need. As this variance became well docu-mented, attempts were made to redress the bal-ance. However, change was limited until the NHS

reforms in 1990 when districts were funded ac-cording to their population size and characteristicsrather than the facilities available in them. Morerecently, a further inequality has been reported:women have been shown to be less likely to re-ceive surgery than men (32). Lower rates of sur-gery in the United Kingdom compared with theUnited States reflect a higher threshold for surgi-cal intervention and greater dependence on medi-cal treatments (based on a review of a region in theMidlands). This difference in threshold alsoserves to reduce demand in regions where levelsof service provision are lower.

Funding Mechanisms andChanges in Control

Before the 1991 NHS reforms, CABG and PTCAwere designated “regional specialities” and werefunded by means of top-sliced allocations from re-gions. Now that districts have become responsiblefor purchasing these services, those districts withhigh levels of activity are beginning to questiontheir spending levels and the relative efficiency ofthe service. Although the purchasing function isstill relatively new, providers are beginning to seethe impact of the reforms and to perceive the mar-ket as a form of regulation. It is unlikely that therewill be a strong increase in CABG and PTCA ac-tivity unless it is achieved through an increase inefficiency. More emphasis will be put, however,on developing protocols and agreeing on criteriato establish appropriate use of these procedures.This process began with a report in a series of epi-demiologically based needs assessments commis-sioned by the Department that stated:

. the use of CABG for disabling angina not re-sponding to medical treatment is based on evi-dence derived from sound RCTS,

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the use of CABG for other indications and an-gioplasty for disabling angina not respondingto medical treatment is based on fair evidencebased on the opinions of experts and indirectevidence, andthe use of CABG or angioplasty for other in-dications is based on poor evidence derivedfrom opinions and indirect evidence (26).

Services in LondonThe Department of Health’s “Report of an Inde-pendent Review of Specialist Services in London”(19) is part of a fundamental review of health carein London. The report suggests that the “idealmodel of tertiary cardiac services consists of threeequally important and interrelated parts,” highquality clinical, diagnostic, treatment, and rehabi-litation services; R&D to improve cardiac ser-vices and their delivery; and staff teaching toensure current knowledge.

It was felt that none of the 14 London centersproviding adult tertiary cardiac services met thesecriteria in all respects. There was a clear case forrationalization to create fewer, larger and strongercenters. The report proposed that nine units are re-quired in London, with additional units elsewherein the southeast and further afield.

The changes proposed are being hotly debatedby each center and are unlikely to happen withoutpolitical commitment. If they do, the likely out-come will be a more equitable distribution of ser-vices rather than any major increase in overallactivity.

Department of Health TargetsIn 1984 the King’s Fund held its first consensusconference in London on CABG. It concluded thatin the United Kingdom a realistic target for CABGshould be 300 operations per million people. De-spite various criticisms of the process, this targetwas endorsed in 1986 during a ministerial an-nouncement at a Tory- sponsored conference bythe government; it later found its way into centralplanning guidelines. The setting of such a clearguideline is unusual and reflects the influence of

the consensus conference and the evidence pub-lished by a health economist from York Universitywho showed that CABG is a cost-effective proce-dure when analyzed according to the concept ofquality-adjusted life years (QUALYS) (47). Al-though this methodology has since been severelycriticized, it still plays a strong role in priority set-ting. This conference also established the credibil-ity of CABG as an effective procedure.

The Department of Health monitors the level ofCABG procedures but has not enforced a limit onthem. Uptake of CABG and PTCA initially re-flected the willingness of teaching hospitals andregions to invest in capital and staff to supportthem. Suggested appropriate levels of CABG andPTCA have had only a limited impact on activity.The Department is currently reviewing whethernumerical targets are the best way to improvequality and quantity. Consideration is also beinggiven to setting up a comprehensive, randomizedstudy to identify which patients are most appropri-ate for CABG, PCTA, or medical treatment.

Clinical Standards Advisory GroupA review was conducted in 1993 by a workingparty of CSAG which concluded that “regionalutilization rates are associated with the availibil-it y of consultant and nonconsultant staff in region-al centres,” and are also affected by varyingpatient expectations. In contrast, district utiliza-tion rates “are associated with the availability of alocal cardiologist and the proximity of a regionalcenter, and inversely associated with the mortalityfrom coronary heart disease” (4).

The review expressed concern about long wait-ing times (particularly for CABG) resulting fromlack of funds. CSAG’S report recommended thatevery district conform to national targets and aimto achieve a minimum level of 300 CABG proce-dures per million population within the next threeyears, with a review of the target possibly byanother consensus conference. The report alsoproposed that a target for PTCA be set. To date,these recommendations have not been followed.


PTCA UpdateBy 1985, 15 hospitals had performed about 1,600PTCA procedures, a rate of 29 per million popula-tion. At that point there was some questioning ofthe clinical effectiveness of the procedure, but asclinicians became more experienced, its routineuse became established. The use of the procedurespread rapidly during the late 1980s so that by1991, 53 (44 NHS and 9 private) centers hadtreated 9,933 patients (a rate of 174 per millionpopulation). This rapid rise has been enabled bythe relatively low capital outlay required forPTCA equipment. In some regions debate hasbeen heated as to whether angioplasty should beundertaken in hospitals without backup cardio-thoracic surgery facilities because of the risk ofperforated blood vessels during angioplasty. Theincrease in rates also reflects a 43 percent increasein the number of consultant cardiovascular physi-cians, from 223 in 1980 to 323 in 1990-againwith a preponderance in the southeast. A greaterproportion of these physicians are able to performPTCA as younger staff trained in the new technol-ogies become consultants. A recent report of theRoyal Colleges of Physicians and Surgeons hasrecommended a level of 300 angioplasties permillion population.

MEDICAL IMAGING (CT AND MRI)

Computed Tomography (CT)The first clinically useful CT scanner was devel-oped at EMI’s Central Research Laboratory inBritain in the late 1960s, with funding from theDepartment of Health. The advantages of thisbrain scanner were quickly recognized; the com-peting technologies of cerebral angiography,pneumo-encephalography, and isotope scanningwere more invasive, riskier, and more uncomfort-able for the patient. Early evaluations were mainlyclinically based. During the mid- 1970s, the De-partment of Health formulated a policy that everyregion should have a least one brain scanner lo-cated in a neuroradiology center. By mid-1977there were 30 brain scanners in the United King-dom, and others were on order (41). Here, clearly,

at least in the initial phase, the Department con-trolled the introduction of the technology.

As the use of brain scanners increased through-out the NHS, EMI and others in the field were pro-ceeding with the development of whole bodyscanners. Interestingly, the clinical evaluation ofwhole body scanning took a different path fromthat of the brain scanner. In the case of the latter,the Department maintained a high degree of con-trol over the initial evaluation, and additional ma-chines were not bought until the Department wassatisfied (although as the clinical advantage wasquickly recognized this process was not particu-larly delaying). With the body scanner, evaluationwas much more complex because so many differ-ent organs were involved, other acceptable tech-niques were available for use in diagnosis, and theeffect on patient management and on the final out-come was not obvious. Even more difficult wasthe ever-developing state of other technologiesagainst which whole body scanners would need tobe compared.

A reduction in the Department budget made itimpracticable to buy enough scanners for a thor-ough exploration. Very early on, various philan-thropists and private institutions had purchasedbody scanners for the NHS or for use in privatehospitals, and these were not subject to the De-partment’s control (41).

The Department decided to evaluate the scan-ner by bringing together all the users to discusstheir studies. This mechanism proved unwieldyand was soon superseded by a committee of ex-perts that aimed to analyze all the available datafrom users in Great Britain and abroad in an at-tempt to 1) determine the scanner’s emergingplace in medical care and 2) encourage researchwhere there were gaps in evaluation. No major,randomized controlled trials were initiated, how-ever. In retrospect, the committee’s impact waslimited (42).

The Role of Charitable Fundsand Clinicians

The diffusion of CT scanners occurred exception-ally quickly, especially considering the initial


high cost of each machine. Although Britain wasthe country of origin of the technology and had thefirst brain scanner in action, the first commercialscanner was installed in the United States. ByApril 1977, 11 EMI whole body scanners wereinstalled or on order in the United Kingdom (41),only 3 of which were bought with NHS funds. Theothers were donated by rich individuals, charities,or endowment funds.

Early on, fundraising events for scanners be-came common. The prime movers were consul-tant radiologists, but they rapidly involved thepublic, encouraging support for this “high-techmagic machine.” The manufacturers also playedtheir part in ensuring that radiologists were awareof the developments. The collaboration of inter-ested c1inicians and the public proved to be a pow-erful agent for diffusion.

When diffusion results from non-NHS fundingwithout central controls, machines are sited ac-cording to resources, not clinical need or capacity.And non-NHS funding also means that ongoingmaintenance of the equipment may not be fundedthrough private donations. Today, institutions arewary of such gifts. In the 1970s, however, hospi-tals had yet to experience decades of reducingbudgets. The first time this problem was discussedpublicly was in Leeds, where the CHC questionedthe Area Health Authority for accepting a bodyscanner from a group of businessmen. As withmost other technologies, most early scanners wereplaced in the south of England, particularly in theLondon area.

UtilizationCT scanners are now available in almost all radio-logical departments. As they are relatively inex-pensive (no more costly than other major pieces ofequipment) and funding is through the hospitalmajor capital budget, acquiring them is relativelyeasy. They are also considered by most managersto be an essential part of any hospital diagnosticcapacity. Numerous evaluations of their use forparticular conditions have been done, but in gen-eral use is widespread among all specialties withlittle consideration of appropriateness or cost ef-

fectiveness. One area of particular debate has beenthe use of brain scans for patients with stroke. The1988 King’s Fund Consensus Statement sug-gested that CT be used for limited indications;more widespread use would have considerable re-source implications.

In 1985, a review of the use of CT in the man-agement of cancer concluded that despite a pauci-ty of information “reported studies [of CT inpatient management in oncology] indicate that CTdirectly alters clinical decisions in 14-30% of pa-tients” (24). There has been no coordinated na-tional evaluation or technology assessmentfollowing the Department’s initial control of—and involvement in the evaluation of—brain scan-ners.

The University of York Centre for Health Eco-nomics (one of the major health economics de-partments in the country) produced a user-guidefor individuals and groups concerned with plan-ning for, and management of a CT scanner in aDistrict General Hospital in 1987 (25). It raiseskey questions such as, “Will CT replace existingforms of examination?” and “What impact willCT have on the demand for other related servicesin the hospital?” However, as it is not a standardDH document but emerges from a research orga-nization, its impact and subsequent use has beenlimited.

Magnetic Resonance Imaging (MRI)The dissemination of MRI, like CT, depended pri-marily on the availability of resources. The initialseven units were supported by the Department ofHealth and MRC. Trials were set up to evaluateMRI’s clinical applications and the Department ofHealth/MRC Coordinating Committee on Clini-cal Application of NMR Imaging commissioned acost-benefit study that also included collection ofdata on costs and throughput at other centers in anattempt to forecast likely implications of the adop-tion of MRI for the NHS. This part of the workproved to be of limited success; several units de-clined to be involved, which was inevitable in anenvironment where management research is con-sidered to be a hindrance.

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Published in January 1990 (48), the commit-tee’s report held that for the applications studied,“MRI is no more cost-effective than existing diag-nostic techniques.” It also stated that the perceiveddiagnostic and therapeutic impact of MRI doesnot necessarily imply a positive effect on the finaloutcomes for patients:

Direct cost of MRI is much greater than thatof CT. This is partly due to higher initial capitalcost, but mainly due to lower throughput of pa-tients in MRI. MRI is more cost effective if usedas the first investigation of choice. Howeverwhere CT is the only scanning modality there isno strong case for investing in MRI.

At the same time, a significant study was beingundertaken within the West Midlands RegionalHealth Authority, funded by its Health ServicesResearch Committee (43). As the service was al-ready up and running, it was not possible to do arandomized controlled study. The report pub-lished in December 1990 determined that MRI didconfer additional benefits in terms of diagnosticimpact, mainly by turning a provisional diagnosisinto a “diagnosis unknown.” MRI also proved tobe excellent at improving the accuracy of the siteor location of an already diagnosed condition. Interms of value or benefit to the patient, however,the results were less obvious. This report furtherconcluded that MRI was an additional cost to eachpatient and that it tended to be used as an addition-al means of investigation rather than to replace ex-isting modes. When introducing such expensiveservices, clinical audit should be established toensure maximum cost-effectiveness.

Neither of these reports was adopted by the De-partment of Health, and both were published byresearch units rather than by the Department orany organization with authority; thus, they havehad little effect on controlling diffusion. The WestMidlands work does not appear to have had anyimpact on policy (44). MRI adoption has beenlimited, mainly due to resource constraints ratherthan determination of need, especially as the NHSreforms have introduced capital changes thatmean that the cost of expensive equipment is to beincluded in providers’ prices to purchasers. Amore recent review of clinical uses of MRI com-

pletely ignores the two earlier studies and is gener-ally positive about MRI’s success for a range ofclinical conditions (l).

A report produced by the Royal College of Ra-diologists in 1992 identified 90 MRI units (37).This report advised that MRI be available to allteaching and district general hospitals withapproximately four MRI units per million popula-tion, or 225 units in total. This considerable in-crease is unlikely to occur on grounds of costrather than appropriateness.

LAPAROSCOPIC SURGERYBecause of the range of technologies encom-passed in this category, the introduction of laparo-scopic surgery provides different examples of thefactors that help and hinder the diffusion of newtechnologies. The development of laparoscopictechniques in the United Kingdom is generally un-stoppable; it is occurring across most medical spe-cialties. Laparoscopic surgery has blurred thedifferences between surgeons, physicians, and ra-diologists; has supported reductions in lengths ofhospital stay and requirements for hospital beds;and has made surgical treatment for many patientsa short-term and relatively pain- and scar-free ex-perience.

Early DiffusionThe early introduction of laparoscopic surgery oc-curred because of a few product champions that,like their first wave of followers, were sited ingeneral hospitals, not only in teaching or academ-ic centers. This is because most of the techniquesdid not require particularly expensive capital out-lay, and in surgery, innovation occurs equally innonteaching and teaching centers.

Laparoscopic cholecystectomy has diffusedquickly throughout many surgical units within thelast three years (box 8-1 ). Uptake has depended onlocal factors, and without any centralized plan-ning there is wide variation in availability.

The private sector has been more easily ablethan the public sector to respond to the potentialsavings of laparoscopic surgery through shorterlengths of stay and increased patient satisfaction.


Laparoscopic treatment of endometriosis and removal of ovarian cysts

● Used and developing, evidence on cost-effectiveness and outcomes insufficient.

■ Diffusion via a small number of enthusiasts.

● No central support, attractive to consumers.

■ Not in position to replace conventional treatments.

Laparoscopic appendectomy

Not routine; routinely used by only one surgeon.

Laparoscopic cholecystectomy

Since 1991, actively supported by surgeons and patients.

● Extends operation time and queries as to outcomes, especially among inexperienced practitioners.

■ Diffusion well en route.

Arthroscopic knee surgery

● Accepted practice but therapeutic application unevenly spread.

● No national policy, but national conferences have played key role in diffusion.

● Underfunding of orthopedics has led to shortage of equipment and facilities.

■ Value of arthroscopy as diagnostic procedure accepted, but use as treatment resisted, especially by older

surgeons (33).

SOURCE J Spiby, 1994

More recently, however, several private insurancecompanies have become concerned about the out-comes of certain procedures (e.g., laparoscopicuterine removal, laparoscopic cholecystectomy)and have banned activity until the results of longerterm studies are available. Within the NHS thishas not happened, as currently there are very lim-ited mechanisms (except for peer pressure) to pre-vent surgeons from undertaking differenttechniques.

Cost Pressures and PolicyOne of the main forces for the development of la-paroscopic procedures has been increasing pres-sure on health care spending. Reduced lengths ofstay in surgery has been seen as essential. Therehas also been considerable political impetus to re-duce waiting lists, which has led NHS managers

to concentrate on supporting initiatives that ap-pear to reduce the need for costly overnight stays.

The assumption that laparoscopic surgery willachieve cost reductions is not, however, well sup-ported by research evidence; in general, the costsand benefits have been poorly studied. Early re-sults of studies of long-term outcomes of some la-paroscopic procedures show, in some cases, thatlaparoscopic procedures delay rather than avertopen surgery, and some have higher levels of com-plications. Some procedures takes two or threetimes longer to perform than conventional surgery(2).

The Department of Health has been noticeablefor its lag in developing policy on laparoscopicsurgery (33). The Department appears to haveconsidered developments within the NHS to bewell ahead of central thinking and policy.


However, concern about the lack of evidenceon efficacy and cost-effectiveness have led to sup-port for several RCTS funded through the nationalR&D strategy. The results of these trials may ormay not be timely enough to influence the diffu-sion of the more popular technologies.

Continued DiffusionPatient preference has played a strong part in thedevelopment of laparoscopic surgery, as patientsare able to return to normal life so much morequickly and suffer considerably less pain (33).More recently, however, concerns have been ex-pressed by GPs about the relentless push to dis-charge patients early after surgery and the lack ofbackup for complications. This problem will needto be addressed if laparoscopic surgery becomesthe norm.

In general, the product champions and early in-novators have been younger surgeons at the begin-ning of their careers and possess the necessaryskills for laparoscopic surgery. For the next stageof innovation, older surgeons and those who areless innovative will have to develop the necessaryskills. This problem has not been addressed untilrecently, and most hospitals have had to rely on re-tirement to achieve change. Some older surgeonswere willing to consider the new techniques, butthey have found it difficult to obtain training, andthey are unlikely to acquire the skills from juniorcolleagues.

In November 1992 the Department’s Manage-ment Executive announced that in collaborationwith the Wolfson Foundation, it was funding threeminimally invasive surgical procedures units.Centers in Scotland, Leeds, and London havebeen designated as training centers, and surgeonswill start to undergo “retraining” shortly. This is aunique initiative, as the need for acquiring newskills to cope with new technologies has been fre-quently discussed but never positively addressedbefore.

TREATMENTS FOR END-STAGERENAL DISEASE (ESRD)Despite the fact that it is a relatively uncommoncondition, ESRD and its different forms of treat-ment were extensively (and often emotionally)discussed in the United Kingdom during the1980s and early 1990s. This attention results fromthe fact that untreated patients die and treatmentcosts are high, particularly as patients need treat-ment for the rest of their lives. Patient survival forall age groups has improved consistently over thelast 15 years, as have levels of service.

International ComparisonsThe United Kingdom has long been regarded as alaggard in its level of treatment of ESRD, evenwhen compared with countries with similar percapita health expenditures; however, far more pa-tients are being treated than 10 years ago. None-theless, compared with Europe and the UnitedStates, relatively fewer elderly patients are ac-cepted, reflecting the lower priority accorded toESRD in the Britain.

Pattern of DiffusionThe United Kingdom has one of the lowestnephrologist to population ratios in developedcountries (20). This is also reflected in the numberof hospital centers for renal replacement therapy(RRT). Many of the existing centers were setupthrough a system of central planning in the 1960s(3). In the 1970s NHS established a few new cen-ters at a time when facilities were mushrooming inother parts of Europe. British centers tend to becentralized in teaching hospitals.

Between 1980 and 1987 the number of UKRRT patients doubled from 128.6 per million pop-ulation to 267.6, but the gap between the UnitedKingdom and other countries narrowed onlyslightly (see table 8-3). This low level of provisionreflects the low level of spending generally onhealth care and the tight constraints that centralcontrol have placed on capital spending on newunits and ongoing expenditures for a high-cost


Year United Kingdom Germany (FRG) France Italy—1980 24.9 46.7 41.6 37,7

1983 33.4 55.8 44.3 45,5

1985 43,1 59.4 42,9 46,8

1987 50.8 84.9 58.1 48.8

SOURCE N B Mays, Management and Resource Allocation m End Stage Failure Units, A Review of Current Issues (London King’s Fund, 1990)

treatment. Spending has been low despite the rela-tively high level of public discussion and relative-ly well-organized lobbies both of patients andprofessionals.

Selection of PatientsA result of the low level of service available is thecareful selection of patients for ESRD treatment.In general, rationing is achieved by preferentiallytreating younger, fitter patients with dependentchildren. Diabetic patients are also less likely toreceive treatment because of the reduced successin their outcomes. This selection appears to be dueto some level of gatekeeping by GPs. In a 1984study, GPs were more likely than hospital physi-cians and nephrologists to assume that treatmentwas not appropriate for the elderly and other high-er risk patients and did not refer such patients,instead treating them conservatively (3). The re-duction in referrals to treatment is also relatedto the low level of nephrologists, who are sitedmainly in the renal units rather than in district gen-eral hospitals.

Despite increases in the numbers of patients re-ceiving ESRD in the 1980s, a survey in 1990 con-cluded that there was still under-referral ofpatients suitable for treatment (20). The authors ofthe survey estimated that the incidence of ESRD is78 per million population, and that only 55 permillion were being treated.

Variations in Treatment RatesWithin the United Kingdom there is a markedvariation in ESRD treatment rates between re-gions (see table 8-4), due primarily to the avail-ability y of facilities. This variation can also be seen

within regions where the uptake is higher by thepopulations living closest to the units (8). In theNorth West Thames region a new peripheral unitwas established to provide a local service forpeople not close to a teaching hospital. Even then,within a few years the population closest to theunit was more likely to receive care than those fur-ther away.

Regional differences can also be seen amongthe different treatment modalities favored byunits. East Anglia’s renal replacement therapyprogram has long been dominated by renal trans-plantation at Cambridge, and continuous ambula-tory percutaneous dialysis (CAPD) has been littleneeded. However, in the Oxford region, trans-plantation has grown more slowly, and home he-modialysis has played a major role, heading othermethods of dialysis. These differences reflect anumber of interacting factors: the preexisting pat-tern of dialysis provision, treatment, and selectionpolicies of individual units and consultants;policy decisions of the RHAs; the degree of popu-lation dispersal; and the availability of differenttypes of resources, including the domestic cir-cumstances of patients (which affect their abilityto cope with different modalities).

Cost-Effectiveness of DifferentTreatments

Care of ESRD is significantly more expensive perpatient than many other diseases. Dialysis is ex-pensive primarily because it is needed for a longperiod of time. The most cost-effective option is asuccessful transplant, but the costs of a graft thatfails in the first year are considerable and compa-rable to the costs of hospital hemodialysis.


Region 1984 1988‘Northern 40.6 58.5

Yorkshire 34.2 44.2

Trent 40,4 49.1

East Anglia 40,5 65.0

NW. Thames 30.6 49.7

NE. Thames 30.3 61.1

S.E. Thames 47.5 76.1

SW. Thames 25.3 23.3

Wessex 27.9 44.8

Oxford 37.5 50.4

South Western 32.6 51.2

West Midlands 26.3 52.0

Mersey 31.3 34.6

North Western 31.5 83.8

Wales 34.3 66.4

Scotland 38.2 62.8

Northern Ireland 20.1 42.5

Isle of Man 33.3 40.0

United Kingdom (total) 33.8 55.0

SOURCE N B Mays Management and Resource A/location in EndStage Failure Units, A Review of Current Issues (London King’sFund, 1990)

In 1990 the Department of Health estimatedthat the first year of hospital hemodialysis coststhe NHS 16,500; home dialysis, 13,000; andCAPD, &14,000. In general the United Kingdomhas a pattern of modalities that reflects a policy toinvest its limited resources for ESRD (approxi-mately 0.6 percent of the annual budget of a typi-cal RHA) by giving greater priority to homedialysis and, recently, to CAPD than do many oth-er countries. This was not necessarily a plannedstrategy was compelled by the strict control exer-cised in the NHS over the opening of new renalunits. Heavy emphasis has also been placed onachieving a high level of transplantation, not onlybecause it is a low-cost option but because it sodramatically achieves a better quality of life.Much work has been done to increase the harvest-ing of cadaver kidneys by developing increasedawareness in medical staff of the need to requestthe use of organs, and by appointing regional

nurses who are responsible for ensuring that hos-pitals are prepared to maximize the availability oforgans.

During the 1980s, in the absence of major capi-tal schemes for renal services in many regions,units responded in a variety of ways to increaseddemands. These include:

■

■

■

development of minimal care dialysis withshorter treatment times and more shifts;setting up satellite units, managed by a parentunit;growth of CAPD, generally considered a cheap-er form of treatment, with the advantage thatpatients can quickly and easily be trained totreat themselves at home; andan increase in transplant rates, which has great-ly helped reduce the required increase of dialy-sis programs.

CAPD has released units from the existingphysical space constraints in the hospital and hasallowed revenue to be converted directly intoadditional patient acceptances. With respect totransplants, minimal care and satellite units wereoften set up because of physical space constraintsas well as the desire to improve geographical ac-cessibility for distant patients. The service is pri-marily concentrated in regional centers; however,despite the fact that satellite units have proved tobe a cost-effective means of providing dialysis,they have not developed as quickly as might havebeen expected.

Erythropoietin (EPO)Erythropoietin for renal patients arrived at a timewhen the increase in demand and the lack of addi-tional resources for ESRD services were posingmajor problems. EPO’S efficacy has been general-ly accepted, but what has been challenged is thelevel of effectiveness for the considerable cost.Health economists have led the debate, question-ing the widespread use of the drug. Units limitedin their resources have had to ration its use to thosemost at risk of anemia due to contraindications totransfusion. More recently, units have found afunding loophole and have asked GPs to prescribe


the drug, as well as other dialysis-associated drugsand consumables, from the budget for primarycare drugs, which is separate from hospital bud-gets and at present is not cash limited. Many GPshave felt unhappy about taking clinical responsi-bility for a drug with which they are unfamiliar,but faced with a patient who will not receive treat-ment if they do not prescribe, most have reluctant-ly agreed to do so. However, it is expected that thefunding mechanism will be changed in 1994 andsuch off-loading will not be possible, thereby in-creasing the pressure on renal units budgets.

Role of the Private SectorThe development of renal services has been as-sisted by the private sector since the mid- 1980s.Commercial companies moved from supplyingdialysis units and, in some cases, helping unitswith financial information and stock managementto directly providing dialysis treatment. The firstprivate dialysis units were set up in Wales in 1985as part of a program to increase the supply of dial-ysis services. Main renal units remain solely onNHS, but subsidiary care centers were contractedto the private sector. The experience has been suc-cessful, but surprisingly (considering the generalchanges in NHS), subsidiary care units have notdeveloped to any major degree elsewhere.

NEONATAL INTENSIVE CAREServices for neonatal care received their first offi-cial support in the United Kingdom in 1961, whenthe Joint Subcommittee and Standing Maternityand Midwifery Advisory Committee recom-mended the creation of a comprehensive programfor the care of neonates. In the same year the Cen-tral Health Services Council argued that specialcare facilities would reduce neonatal mortality.Before 1961, services had developed mainlywhere there were enthusiasts in teaching hospi-tals. The development of the service was pro-moted by professionals, and there was littlescientific evidence for their claims that neonatalmortality would be reduced or that reductionsseen at that time were related to spec ial care facili-ties.

In 1971 the Sheldon report advocated a two-tiersystem of service provision, with 1 ) special careunits in each district for low-birthweight babiesand those with illnesses unique to the newborn,and 2) neonatal intensive care units (NICUs) thatwould provide higher level care at specialistteaching hospitals (39). As well as centralizing ex-pert care, the latter were regarded as a prerequisitefor training doctors and nurses in the special carerequired by the sickest neonates. There was at thetime some suggestion that such centralizationwould increase the risk of infection or the possi-bility of over-aggressive treatment, but this wasnot investigated in any serious manner—probablybecause those doing research in the area weremainly proponents of the service. The consensuswas that each region should have one to three NI-CUS: these should be sited where the high-risk ob-stetric service was sited and where specificexpertise in neonatal intensive care existed.

Three reports of the Social Services Committeeduring the 1980s (5) recommended the addition ofa third tier to neonatal services, such that all dis-tricts would provide short-term care backed up bysubregional facilities at larger maternity units anda regional specialist perinatal center. The serviceby then was well established, although in most re-gions the actual distribution of services and levelof expertise available depended on local circum-stance rather than careful planning. Two explana-tions for this can be put forward: first, the lack ofhard evidence on the service; and second (andmore likely), the establishment by younger pedia-tricians of one or two cots in smaller hospitals inorder to create a local service and provide an extraprofessional challenge for themselves and otherstaff. Several regions produced planning guide-lines that they backed up with resources, but sub-sequent reviews found that small local serviceswith one or two cots were being set up by clini-cians despite these guidelines (29).

Policies and DiffusionDuring the 1980s the main policy thrust was to-ward improvement in neonatal services. Theseservices were singled out by the Royal College of


Physicians in 1988 and the National Audit Officein 1990 as an area for improvement, and theNHS’S Chief Executive made it a priority in 1990for regions and districts to review their maternityand neonatal services with a view to further reduc-tions in mortality (31 ,36).

In England between 1980 and 1986, the num-ber of cots for neonatal intensive care more thandoubled, and birthweight-specific perinatal andneonatal mortality fell in all categories of birth-weight. There were, however, a few skeptics whohad reservations about the rapid growth in neona-tal services, doubting that neonatal intensive carewas a determinant in the reduction in neonatalmortality. Concern was also expressed about thehigh cost of these services and the long-termhealth outcomes. By this time it was deemed un-ethical to undertake a randomized trial, and advo-cates of NICUs cited experience abroad and expertopinion rather than data. Typically, the discussioncentered on the lack of services and problems inobtaining a cot for all the babies who required thislevel of care.

In an attempt to address these criticisms, oneregion, Trent, undertook a prospective study ex-amining the short-term outcome (survival to dis-charge) of all infants who required admission to ababy care unit. They showed that infants of 28weeks’ gestation or less who received all their per-inatal care in one of five large centers (each pro-viding more than 600 ventilator-days per year)had significantly better survival than infantstreated throughout their entire course at one of 12smaller units (22). These differences occurred de-spite the elective transfer of many of the sickest in-fants from smaller to larger units. Differences insurvival between more mature infants were notsignificant.

The National Perinatal Epidemiology Unit inOxford, which has been central in developing anunderstanding of technology assessment and therelative valid it y of different types of c1in icaltrials,raised questions regarding the interpretation of theresults and implications for policy (30). It sug-gested that biases may have affected the results,and that the differences in mortality might havebeen in part the result of differences in unmea-

sured risk factors; moreover, a decision to transferall babies might not reduce mortality but insteadincrease the mortal it y rate for admissions to the re-ferral units as they take in higher risk babies. Theoutcome was that the case for regional NICUS wasnot made, but policy continued to support them.

Throughout the development of neonatal inten-sive care, the argument for it has been that it re-duces neonatal mortality. Little or no referencehas been made to its impact on morbidity. Con-cern has been expressed about the possibility of anincreased level of severely mentally and physical-ly handicapped children, but little epidemiologic-al evidence has been forthcoming. Recent workindicates that increasing numbers of preterm in-fants survive without (major) handicaps but withmore subtle long-term problems, such as learningdifficulties and lower school grades. The chief im-plication of such information is the need to pressfor better obstetric care so as avoid the necessity ofneonatal intensive care.

Financing NICUS and the NHS ReformsUntil the 1990 NHS reforms, the responsibility forfinancing and developing neonatal intensive carehad belonged primarily to RHAs. The NHS re-forms aimed to devolve responsibility to the dis-tricts for such services so that their relativeimportance would be assessed against the totalneeds of the population. This change created ma-jor concern among those involved in the service,who feared that centralization would be eroded(34). It was felt that the reforms might encouragethe establishment of small, less well-equipped NI-CUS, with few if any effective constraints or con-trols over those providing neonatal care. Thisconcern was reiterated in a House of CommonsHealth Committee report in 1992, which statedthat “we are not persuaded that the establishmentof contracts for regional services for perinatal andneonatal intensive care can be left to market forcesand audit. ”

The service became one of the first to be re-viewed by the Clinical Advisory Group set up bythe Secretary of State. Its report on neonatal inten-sive care concentrated primarily on access, as had


so many of’ the previous official reports on this ser-vice. Overall. it was felt that contracting had notsignificantly affected the service. There was stillconsiderable variation across the country in theservice provided, and in some regions the servicewas under considerable pressure. However, it ap-peared that purchasers were intending to move anincreased proportion of intensive care to localunits (probably for financial rather than clinicalreasons). and this might have a deleterious effecton the viability of the larger training institutionsand on quality of care. The report noted that fewconsistent measures of quality existed and that apopulation-based audit of outcome in terms ofmortality and disability was required.

Extracorporeal Membrane Oxygenation(ECMO)

The well-controlled introduction of ECMO to theUnited Kingdom is due largely to the influence ofthe perinatal research unit in Oxford. ECMO wasintroduced unevaluated in Leicester in 1991. Be-fore any other units were installed, planning by re-searchers at Oxford University began for arandomized controlled trial to cover the entireUnited Kingdom. Recruitment started in January1993: to date, more than 80 babies have been in-cluded, making it by far the biggest controlledtrial of ECMO in the world. Results are expectedin 1996.

SCREENING FOR BREAST CANCERInterest in screening for breast cancer developedslowly in the 1970s mainly in the form of speciallyfunded projects or adjuncts to symptomatic mam-mography services. During the early 1980s, a con-siderable lobby developed; it consisted ofsurgeons who specialized in breast cancer treat-ment and women’s groups. In 1985 the healthminister announced that a committee would be setup to:

● consider the information now available onbreast cancer screening by mammography:

■ the extent to which the literature suggests nec-essary changes in policy on the provision of

mammographic facilities and the screening ofsymptomless women;suggest a range of policy options and assess the

benefits and costs associated with them; andidentify the service, planning, labor, financial,and other implications of implementing suchoptions.

Forrest ReportThe committee reported in November 1986 in adocument known as the Forrest report (9). On thebasis of evidence from randomized trials in NewYork and Sweden and two studies in the Nether-lands, the committee concluded that “screeningcan reduce mortality from breast cancer, althoughthe reduction varies with the age of the womenscreened. ” Despite the existence of a large, seven-year, multicenter, population-based trial that wasbeing conducted and was due to report in 1988, thecommittee recommended the introduction of a na-tional breast screening service for women be-tween the ages of 50 and 64, with the expectationof reducing deaths from breast cancer by a third ormore. The key screening test was to be one-view,high-quality, medio-lateral oblique-view mam-mography. The program was to include a personalinvitation to all eligible women, arrangements toensure that positive results were followed up, aspecialist team to assess detected abnormalities, acall-and-recall system, quality control, and a des-ignated person responsible for managing localscreening services.

This report was fully implemented because thegovernment, on announcing its acceptance of therecommendations, also agreed to finance thescreening program in full. Over &50 million na-tionally was invested of new funds to the NHSprovided by the Treasury. By 1991 there was 77screening programs covering the 190 health au-thorities.

On a more practical level, the Forrest reportclearly acknowledged that “the development ofany national programme will require careful plan-ning not only of the basic screening services butalso to ensure the availability of the necessary as-


sessment, diagnostic and treatment services forscreen-detected abnormalities.”

Results of the U.K. TrialsIn 1990 the Scottish arm of the U.K. Trial for theEarly Detection of Breast Cancer reported a non-significant reduction in mortal it y after seven yearswith an initial attendance rate of 61 percent (35).The net result of the trial was to emphasize that ahigh level of reduction in mortality could beachieved only with high participation rate inscreening (46). The service was set up with a well-structured call-and-recall system, but it becameclear that although uptakes of 80 to 90 percentwere possible in areas of high socioeconomic sta-tus, such rates were not achievable in inner-cityareas and among those populations that tradition-ally do not use preventive services (28).

During this period the results of the U.K. trialled to criticism of the Forrest report. It was sug-gested that the expectation of a 30 percent reduc-tion in mortality was too ambitious; that thedisadvantages of screening had not been ade-quately measured, especially in view of the num-ber of false positives; and that the group had beenbiased and should have considered selectivescreening to ensure proper use of resources.

The National Screening ProgramFollowing the Forrest report, major new evidencewas reviewed by Forrest and a group of experts.This evidence consisted of the U.K. trial, furtherevidence from Malmo (Sweden) and New York,and the Edinburgh randomized trial. This reviewconcluded that “the original evidence that screen-ing for breast cancer can reduce breast cancermortality is supported by additional results fromrecent evidence. The expected impact after about10 years was that roughly 1,250 deaths attribut-able to breast cancer would be prevented each yearin the United Kingdom.

Concerns about translating trial results into na-tional experience have focused on three main is-sues: population coverage, skills development,and proper introduction of the program. Adequatepopulation coverage is clearly challenging insome parts of the country. The Forrest review ac-knowledged this and identified difficulties withthe population denominator register used for con-tacting women about attending their screening.Certain sectors of the population are unlikely toattend even if contacted, however—a problemthat is being addressed locally with a range of ini-tiatives.

It was reported that the development of skillsthrough training centers had been sufficient totrain the required staff in three years. In fact, thetraining program had initially lagged but eventu-ally came to play an ongoing role in supportingcontinuing education.

The U.K. Cancer Coordinating CommitteeBreast Screening Sub-Committee set up threetrials looking at the interval between screeningepisodes, the number of views, and the effect ofscreening women under the age of 50. The Sub-Committee also coordinates research on accept-ability and economics. This high level of centralcontrol reflects the program’s unusual commit-ment to centralization and uniformity.

Impact of the NHS ReformsThe NHS reforms at present have not affected thescreening service in any major way. At present,the funding for breast screening and the central-ized style of service provision have been pro-tected, but this will not necessarily continue to bethe case.

Breast screening has been given additional im-petus by virtue of its inclusion in the nationalhealth strategy. The proposed target is to reducethe death rate for breast cancer in the populationinvited for screening by at least 25 percent.

Chapter 8 Health Care Technology in the United Kingdom | 271

CHAPTER SUMMARYThe picture painted above shows a varied patternof influences on the introduction of health caretechnologies in the United Kingdom and little evi-dence of a coherent policy for technology devel-opment until very recently.

In the past, the constant requirement to limit theavailability y of care has been met primarily by gen-eral practitioners who act as gatekeepers and bythe acceptance of waiting lists for nonemergencycare. This system of priorities has become politi-cally unacceptable over the last decade, however,as shown by the Department of Health’s waitinglist initiative. Patients have been encouraged bythe Patients’ Charter to demand their “rights.”Consequently, without any major increase in re-sources, different mechanisms for the control ofspending have had to be developed.

To date, limiting development by constrainingresources has resulted in a haphazard control oftechnological development based on cost consid-erations rather than on effectiveness. Those whohave found it easiest to obtain new resources (pri-marily the main teaching hospitals) have been themost successful in introducing new technologiesand those who live closest to such facilities aremore likely to receive care.

Looking at the way in which different technolo-gies have developed in the United Kingdom, it isclear that the government has had little control oftechnological development except in the case ofbreast cancer screening, where specific fundingwas provided to fund a new national program.With other technologies, the government has triedto influence development by more indirect routes,such as identifying expected service levels orplanning norms. Yet without any real method ofenforcement, such means appear to have had littleinfluence.

The most important factor in technology diffu-sion has been product champions: individual cli-nicians or members of key regional or districtmanagement teams who have found appropriate

ways of obtaining resources (public, private, orcharitable), and ushering in the introduction ofnew developments. Such champions have beenfound mainly in teaching institutions, where theenvironment is more encouraging (both in termsof availability of resources and tolerance of moremaverick personalities). That this is not alwaystrue is illustrated by the development of local re-nal dialysis units, minimally invasive surgery, andneonatal units.

Over the past decade, awareness of the con-cepts of appropriateness, effectiveness, and cost-benefit analysis have moved to center stage on theagenda of purchasers and the NHS ManagementExecutive. Ten years ago, few managers or politi-cians were aware of the level of inappropriate useof technology or of new developments that wereabout to occur—and of how to assess their useful-ness. Clinicians continued to battle for resourcesfor their particular specialities but were rarelychallenged on the effectiveness of their activities.

The main challenge today is finding ways of us-ing the NHS reforms to implement technologyassessment results so as to ensure the most cost-effective use of resources. The creation and ap-pointment of a national Director of Research andDevelopment and the commitment of this entirestructure to technology assessment is a major stepforward. At present, however, there appears to bemore discussion and publication of strategies thanfunding of useful research or use of previous workto effect change. Little new money is available,and at regional levels, R&D directors are finding itdifficult to obtain realistic budgets.

Some regions have also had difficulties findingappropriately qualified candidates. Most seniorclinicians with a research background who are ac-ceptable to the medical fraternity are knowledge-able only about their own specialties; they do nothave an overview of the whole of health care, norare they experienced in working within health ser-vice management. It is hoped that these problemswill be resolved and that the real power of the post-


holders will be felt. Unfortunately, this will inevit-ably be delayed by the structural reorganization ofthe regional health authorities and potential dis-location of this function.

Possibly more effective in achieving changewill be the purchasing authorities. In theory, theyplay a powerful role in identifying what they wishto purchase and ensuring through contracts thatdesired patterns of health care are provided. Inreality, however, difficulties arise in identifyingexactly what is required and in using the contractprocess effectively.

In summary, although the United Kingdom didnot become systematically involved in technolo-gy assessment until recently, the field has recentlybeen much publicized and discussed. It is ironicthat the randomized clinical trials and cost-effec-tiveness studies undertaken in British researchunits have had relatively little impact on healthcare and its management up to now. The increas-ing necessity for making choices, along with theincreasing availability of research from healthcare technology assessment, makes this problemunlikely to persist.

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