National standards ("frameworks") that essentially define access to and eligibility for specified types of care and services are formulated by the National Service Frameworks (NSFs) body. Typically, the NSFs set up one new framework per year. While frameworks have some resemblance to clinical pathways, they are less detailed. In their annual process called the Annual Health Check, the Health Care Commissions serve as the system regulators. The commissions evaluate the system's performance against the core standards that apply to existing performance and the developmental standards that reflect the capacity to improve. The role of the National Institute for Health and Clinical Excellence (NICE) is to develop the working guidelines that will be followed by National Health Service (NHS) provider organizations in complying with the frameworks.
The present (2007) agency is an outgrowth of the National Institute for Clinical Excellence (also known as NICE) with an expanded role and mission. In 2005, the functions of the NHS's Health Development Agency (HDA) were transferred to NICE.
The Department of Health, a subdivision of the NHS, commissions NICE to develop guidelines applying to clinical practice, public health, and health care technology. NICE guidelines reflect and embody the principles of evidence-based medicine as well as of cost-effectiveness. Guidelines on a particular subject are developed in response to needs as perceived and articulated by the public, the health care community, and professional and technology-oriented organizations, and proposed by them to NICE for action. NHS providers to whom a NICE guideline, or "guidance" as they are called, applies are then expected to follow this guideline in their practice, taking it "fully into account when deciding what treatments to give people" (A Guide to NICE, 2005, p. 9).
In one sense, the NICE guidances show a superficial resemblance to the advisories published by the US Agency for Healthcare Research and Quality (AHRQ), although NICE publishes specific implementation templates to support its guidances, listing the steps in the implementation process. NICE guidance does not apply uniformly to the entire United Kingdom. Its guidance on health technologies and clinical practice applies to England and Wales. Its guidance on the safety and efficacy of interventional procedures applies to England, Wales, and Scotland. The NICE guidances on public health practices apply to England alone.
QMHC: Dr Leng, how and when did NICE get started?
GL: NICE came into being on April 1, 1999, as part of an initiative designed to eliminate the inequities that existed in access to the best in medical care. The new Labor Government had just been elected, and inequitable access to good health care was an issue. We had a history in the United Kingdom of inconsistent access to high-quality health care. While one provider was getting good results by using a state of the art procedure in treating some diagnosis, the provider next door might be using an outdated, ineffective approach with less satisfactory results. It was important to develop some way to standardize treatment approaches at the highest levels among NHS providers in order to try to ensure uniformly good care. We had to eliminate what was sometimes referred to as the "health care lottery."
Last year-April 1, 2005-we brought another NHS agency, the HDA, into NICE. This meant that our scope was expanded to include public health. We now provide guidance on a whole range of public health projects.
QMHC: Did these changes involve a shift in your focus?
GL: Yes, they did. My responsibilities changed from essentially research and planning to implementation.
QMHC: That must give your agency a great deal of power. Last night I heard a television commentator talking about NICE issuing an endorsement or guidance involving the use of some medication. The implication was that NICE has enormous power to control medications used in the NHS provider organizations.
GL: Well, the media may be giving an exaggerated impression of NICE's power. However, when NICE issues a guideline, called a "guidance," covering a treatment measure addressed in a core standard, the funding needed to support practitioner and provider compliance with that guidance must be in place within three months. In the case of a guidance reflecting a developmental standard, provider organizations are allowed more than three months for implementation.
QMHC: Would you describe NICE's organizational and governance structure?
GL: Well, we report to the NHS. We are governed by a fifteen-member board. The board's standing committees are the Audit Committee, the Citizen's Council Committee, and the Remuneration and Terms of Service Committee. In addition, NICE calls upon the expertise of the NHS and the broad health care community to assist in its work. We rely on several independent advisory committees, including those on Interventional Procedures, Public Health Interventions, Research and Development, and Technology Appraisal.
QMHC: How does NICE goes about developing guidances?
GL: We work with a wide variety of consultative and advisory bodies. We also work with several independent academic centers representing universities and other academic groups in evaluating technology and technological approaches. In developing clinical guidelines, the royal medical and nursing colleges, professional bodies, and patient carer [provider] organizations work with NICE. When more information is needed before guidance can be developed on an interventional procedure, we convene an advisory committee composed of experts in the aspect of care being studied. A great deal of research is done. NICE doesn't make these decisions unilaterally. It does take quite a long time. It's not the quick process you might assume. We don't always get unanimous agreement with our decisions. You can't please all of the interested parties.
QMHC: Are these guidance statements published together in a single manual, or in some other form?
GL: They are published as separate documents at various dates, as they are developed.
QMHC: Which NHS branch funds this activity?
GL: The Department of Health. This funding arrangement is quite an important mechanism in making things work.
QMHC: That's interesting. You have a lot of power, whether you like it or not. In the United States, while The Joint Commission has tremendous power to influence the quality of hospital care, it does not have legal authority, bestowed by a legislative or governmental body, to enforce adherence to its guidelines, or standards. Its power stems from the fact that the Centers for Medicare & Medicaid Services (CMS) and the private insurers rely in large part on demonstrated compliance with The Joint Commission standards and patient care policies in evaluating and paying for hospital care. How does the NHS assess compliance with the NICE guidances?
GL: The Healthcare Commissions are the bodies that inspect performance against the guidance. They also review costing guides. To assist providers in complying with guidances, we provide spreadsheets and analytical tools as well. Often the tasks involved in complying are difficult for the provider- not the costs per se. It's the planning that presents difficulty.
QMHC: Does your purview extend beyond hospitals? GL: Yes, it extends to all NHS providers. Providers that do not belong to the NHS generally meet the standards and guidances, as well, although they are not required to do so.
QMHC: As you probably know, for the past few months, the US health care system and the media have been giving a lot of attention to the prevalence of obesity and the associated health problems. Now, this week, I'm seeing a comparable amount of coverage of these topics in the British media. From what I read and hear, it appears that the obesity problem is as serious in the United Kingdom as it is in the United States. What is NICE's take on this subject?
GL: We have quite a lot of research to draw on. We've found a statistically significant higher incidence of obesity in the North and in Yorkshire, for example. Why is this the case? Who knows? There may be some cultural influences at work. Lower activity levels are contributing to the weight gains we're seeing, particularly in children. The prevalence of computers, computer games, and television probably is playing a part. We have recently issued a new guidance requiring practitioners to give appropriate programs and recommendations to patients at risk for weight problems. There's no magic bullet.We have to use an array of approaches.
QMHC: What did you do before joining NICE?
GL: I ama medical doctor, formerly in general practice. My special interest area is in vascular problems. I was part of the Cochrane Peripheral Vascular Disease group at Edinburgh. I used to run NICE's clinical guideline program. But-handling implementation and its issues-that's an entirely different thing.
QMHC: Would you say that you're an agent of change?
GL: Yes, I would.
QMHC: It doesn't sound as if you have much time in your life for hobbies and leisure interests. Do you have any hobbies? GL: No formal hobbies such as fishing or golf. I have two teenage children, and I spend time with them. A couple of years ago we bought a house in Bedfordshire-quite a rural setting. Our garden is large but untidy.
QMHC: Speaking of country houses and hobbies, a couple of years ago a hospital official whom I was interviewing told me that she had bought an old farmhouse that was reputed to be haunted. So she began researching ghosts.
GL: We don't have ghosts, but we do have lots of chickens. Chickens seem to be popular around our place.