Background
The term “guideline” needs to be defined before any meaningful discussion can occur about their need and more importantly, interpretation. “Guideline” was originally defined as “a cord or rope to aid a passer over a difficult point or to permit retracing a course.” In medicine a guideline is a document that should influence decisions and provide criteria regarding diagnosis, management, and treatment in specific areas of health care. Such documents have been in use over the entire history of medicine. However, in contrast to previous approaches, often based on tradition or authority, modern medical guidelines are based on an examination of current evidence within the paradigm of evidence-based medicine.
Modern clinical guidelines identify, summarize, and evaluate the highest quality evidence and most current data about prevention, diagnosis, prognosis, therapy including dosage of medications, risk/benefit, and cost-effectiveness. Prior and some current guidelines include consensus statements on best practice for a given disease, like hypertension, where evidence is lacking in some areas. Some recent guideline committees like the Expert Panel Report, also known as the JNC 8 (Eighth Joint National Committee) were instructed to stick purely to evidence and minimize expert opinion when designing the latest, now former NIH (National Institutes of Health) guidelines. This approach leads to other shortcomings as will be noted later in the chapter. A health care provider is expected to know the medical guidelines for his or her area of medicine, and decide whether the recommendations are appropriate for an individual patient.
Additional objectives of clinical guidelines are to standardize medical care, raise quality of care, and reduce several kinds of risk (to the patient, health care provider, medical insurers, and health plans or government). Put simply, “what is the most cost-effective way of getting the correct diagnosis or treatment for the patient and payer?”
Guidelines are usually produced at national or international levels by medical associations or governmental bodies, such as the United States Agency for Healthcare Research and Quality or formally the National Institute of Health Heart Lung and Blood Institute now given to the American Heart Association/American College of Cardiology Societies (ACC/AHA guidelines). In the United Kingdom the National Institute for Health and Care Excellence (NICE) carries out guideline development across all areas of medicine and the European Society of Hypertension (ESH) has its own set of guidelines as do most individual nations around the world.
Although guidelines are useful in many settings, recently some payers in the United States and certain government agencies have established them more as “edicts of performance” rather than true guidelines. Guidelines change based on the most recent evidence, as is illustrated by changes in blood pressure goals since the inception of blood pressure guidelines in 1977 ( Fig. 51.1 ). Certain insurers provide grades and basically elevate guidelines to some ‘holy grail’ status of practice, in a way not justified or expected by anyone who has written such guidance. Thus, what was meant as a meaningful informative guide for physicians is increasingly used to mandate performance and judge outcomes.
This edict of exclusively evidence-based guidelines emerged around 2008 in the United States when the American Heart Association produced a report noting that there was a 48% increase in the number of recommendations, however, the majority had class 2 level of evidence. Only 9% (245/2711) were based on the highest standard of evidence, that is class I and level A evidence. Thus, it was concluded by almost all guideline development groups that recommendations should be restricted to those supported by high quality evidence. Unfortunately, in some important areas of medicine, rigid application of this policy would severely limit recommendations needed in routine clinical practice.
Guideline developers are aware of this limitation and try to balance the high quality evidence with common sense, experience and pragmatism. As a result, guidelines may have both methodological problems and limitations based on the limitations of the evidence. Another concern has been potential conflicts of interest. It has been concluded, without good justification, that guideline developers must always be unduly influenced by pharmaceutical companies to bias statements favoring certain products. In many cases intellectual conflicts of interest, more than industry-based conflicts, are apparent among guideline development groups Hence, it is impossible to eliminate conflicts of interest based only on monetary remuneration. This and other partially unjustified edicts have resulted in guidelines that have a very limited scope, as a result of lack of evidence in key areas and committee members who have limited experience in the areas under discussion.
The key is to publish clear methodology for guideline development so that readers have a clear understanding of the process of how the evidence has been used to frame the recommendations. Thus, guidelines from countries that require evidence-based guidelines interpreted by professionals who are experienced clinicians in a respective area may be more reasonable as compared with the more draconian approach where people with knowledge of methodology but no experience in the topic area in question or who lack patient interaction experience are interpreting the evidence.
Some simple clinical practice guidelines are not routinely followed to the extent they might be and that providing a nurse or other health care professional with a checklist of recommended procedures can result in the attending physician being reminded, in a timely manner, regarding procedures that might have been overlooked. This illustrates that a team approach is needed for guideline implementation and translation to improved medical care.
This chapter will focus on the development of hypertension guidelines through the years in the United States, United Kingdom, and Europe and provide a perspective on where we came from and where we are today.
United States Guidelines
The major organization producing guidelines for management of hypertension until 2011 was the Heart Lung and Blood Institute of the NIH. This is the group that produced the Joint National Committee Reports I-7 and commissioned what is known as the Expert Panel Report ( Fig. 51.1 ). This effort started shortly after some of the first Framingham data were published in the 1960s. The Framingham Heart Study, a longitudinal study begun in 1949, reported a strong correlation between elevated blood pressure (BP) and heart attacks, heart failure, stroke, and kidney damage. In addition to this data, one of the first clinical outcome trials, developed by Ed Freis, the Veterans Administration (VA) Cooperative Study was published in 1970. This trial demonstrated that lowering BP with the available medications in male patients with severe hypertension dramatically improved their outcome when compared with placebo.
Based on epidemiological and treatment data available, the National High Blood Pressure Education Program was born in 1973, with the goal of enlightening health care professionals and the public on the dangers of hypertension and the lifesaving benefits of treatment. It was apparent that the Federal Government, industry, organized medicine, volunteer groups, physicians, nurses, and other professionals could work together effectively with a Coordinating Committee of the National High Blood Pressure Education Program to control a major disease.
In 1977, the First Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure established guidelines for management and introduced the stepped-care approach to hypertension treatment. Since then, guidelines have been revised approximately every 4 to 5 years in 1980, 1984, 1988, 1993, 1997, 2003 ( Fig. 51.1 ). The exception to this was the Expert Panel Report (JNC 8), which was commissioned in 2008 but published 11 years after JNC 7.
The guideline committees that originally consisted of 10 individuals chosen from national organizations by the National Heart, Lung and Blood Institute (NHLBI) to review and evaluate available data on diagnostic and treatment approaches and to publish their conclusions, had grown to 50 consultants from a diverse group of organizations ( Box 51.1 ). These organizations approved all JNC reports except JNC 8, a document reviewed by only 25 national experts.
American Society of Health-System Pharmacists
American Society of Hypertension
American Society of Nephrology
Association of Black Cardiologists
Citizens for Public Action on High Blood Pressure and Cholesterol, Inc.
Hypertension Education Foundation, Inc.
International Society on Hypertension in Blacks
National Black Nurses Association, Inc.
National Hypertension Association, Inc.
National Kidney Foundation, Inc.
National Medical Association
National Optometric Association
National Stroke Association
NHLBI Ad Hoc Committee on Minority Populations
Society for Nutrition Education
The Society of Geriatric Cardiology
American Academy of Family Physicians
American Academy of Neurology
American Academy of Ophthalmology
American Academy of Physician Assistants
American Association of Occupational Health Nurses
American College of Cardiology
American College of Chest Physicians
American College of Occupational and Environmental Medicine
American College of Physicians—American Society of Internal Medicine
American College of Preventive Medicine
American Dental Association
American Diabetes Association
American Dietetic Association
American Heart Association
American Hospital Association
American Medical Association
American Nurses Association
American Optometric Association
American Osteopathic Association
American Pharmaceutical Association
American Podiatric Medical Association
American Public Health Association
American Red Cross
Federal Agencies
Agency for Healthcare Research and Quality
Centers for Medicare & Medicaid Services
Department of Veterans Affairs
Health Resources and Services Administration
National Center for Health Statistics
National Heart, Lung, and Blood Institute
National Institute of Diabetes and Digestive and Kidney Diseases
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