LOOK IT UP: Clinical Guidelines Explained (Part 1)
By Rick Rader, MD, FAAIDD, FAADM, DHL (hon) | Editor in Chief, HELEN Journal
Growing up in 1950s America, most of us had one thing in common. A stately collection of books sat in a bookcase in nearly everyone’s living room — it was the Encyclopedia Britannica.
Knowledge was as our fingertips, like never before. It was a revolutionary!
An army of door-to-door encyclopedia salesmen turned our homes into research centers – with volumes of bound encyclopedias. Prior to this, our only research option was the public library, usually miles away.
Before encyclopedias, public libraries were the only option for research.
Parents also had a new catchphrase for constant cries of “but why?” and “but how?” from their children. It didn’t matter what the subject. When children asked about The Magna Carta, carbon atoms or the Crusades, there was a universal chant from parents: “Look it up.”
And we did.
In fact, this catchphrase went viral before “going viral” was a thing. During ward rounds, when medical students, interns and residents wanted to know (or were quizzed) what the recommended dosage of moxifloxacin was, or the differential diagnosis of right hypochondriac pain, or what the current thinking on fecal transplants were, they certainly heard the battle cry, “Look it up.” Back in the 1980’s, we had our clinic coat pockets full of spiral bound manuals and index cards, all of which served to look it up on the run. Now our hand-held devices accomplish it in nanoseconds.
Over the years, when it came to the big picture of identifying and initiating complete treatment plans, we needed something more than hastily written notes on the back of envelopes. We needed guidance, instructions, navigation, direction and evidence of what was best, what was needed, and what was called for. Typically, medical care is based on the culture of where you received your training. How they treated diabetes in children was different at Duke, Hopkins, Miami and Rochester. It was influenced by the department chiefs, chairs, professors and how “they” were taught. And for the most part, it worked and contributed to the high level of medical care that made American medicine the envy of the world.
Pharmacy students pictured at North Carolina Area Health Education Center program in the 1980s.
Over time, many of these diverse approaches to medical treatment were challenged. The emergence of “evidence-based” medicine took hold and there was a push for more standardized treatment and practice that all patients could expect, regardless of the “zip code” of care.
This led to the development, implementation and support of “clinical practice guidelines.”
“Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”(Institute of Medicine, 1990)
Issued by third-party organizations, these guidelines define the role of specific diagnostic and treatment modalities in the diagnosis and management of patients. The statements contain recommendations that are based on evidence from a rigorous systematic review and synthesis of the published medical literature.
These guidelines are not fixed protocols that must be followed, but are intended for health care professionals and providers to consider. While they identify and describe generally recommended courses of intervention, they are not presented as a substitute for the advice of a physician or other knowledgeable health care professional or provider.
What are clinical practice guidelines?
Clinical practice guidelines (or simply “clinical guidelines”) are recommendations on how to diagnose and treat a medical condition. They are mainly written for doctors, but also for nurses and other health care professionals.
Clinical guidelines are meant to help ensure that patients receive appropriate treatment and care. For instance, the guidelines on cervical cancer include recommendations on the diagnosis and treatment, as well as recommendations concerning psychosocial support, rehabilitation and follow-up care.
Guidelines summarize the current medical knowledge, weigh the benefits and harms of diagnostic procedures and treatments, and give specific recommendations based on this information. They should also provide information about the scientific evidence supporting those recommendations. Clinical practice guidelines must be updated regularly.
Unlike directives, guidelines aren’t legally binding. In other words, doctors don’t have to follow the recommendations if they don’t think they are suitable for certain patients. But deviations from guidelines must be justified.
How are clinical practice guidelines developed?
Ideally, clinical guidelines should be developed systematically – in other words, following a certain procedure:
First a guideline committee is formed, including specialists to cover all the important aspects of the medical condition in question. The committee is usually led by a member of the medical association responsible for the medical condition.
It collects as much information as possible from different sources and assesses the information based on predetermined criteria. The various assessments and opinions of the committee members are discussed and taken into consideration when writing the guidelines. In other words, the recommendations are "consensus-based."
The committee members have to declare any conflicts of interest. For instance, they have to say whether they have worked for a pharmaceutical company that makes medication to treat the medical condition that the clinical guidelines are being written about.
How can you recognize good clinical guidelines?
Good clinical guidelines should be based on up-to-date scientific knowledge, and it should be possible to follow the recommendations in daily medical practice. International uniform standards are now used worldwide for the assessment of clinical guidelines. In Germany, the Association of the Scientific Medical Societies (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, or AWMF) coordinates the development of clinical guidelines. It divides guidelines into four categories:
S1 guidelines: These guidelines summarize the recommendations of experts. They do not systematically compile and assess the medical knowledge in the area in question. So, the recommendations made in S1 guidelines aren’t very reliable.
S2K guidelines: S2K guidelines are developed by a committee of specialists in the medical field in question. The recommendations made are consensus-based. Because medical information isn’t systematically collected and assessed here either, the information that the recommendations are based on isn’t very reliable.
S2e guidelines: Here, the guideline committee systematically compiles the medical knowledge from different sources. But if the members of the committee disagree, they do not use a consensus-based approach to develop the guidelines.
S3 guidelines: This is the only category of guidelines that meets all of the following requirements: The guideline committee includes experts representing various areas of the field in question, and the medical knowledge is systematically collected and assessed. What’s more, if different members of the committee have different views, a specific procedure is followed in order to develop consensus-based recommendations.
S3 guidelines are the most reliable kind of guidelines, but they also involve the most effort: It can take several years to develop them. When S3 guidelines are developed for doctors and health care professionals, patient guidelines are usually developed too.
Resource: Institute for Quality and Efficiency in Health Care, National Institutes of Health, National Center for Complementary and Integrative Health