Putting All Guidelines Into Perspective

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.