Clinical guidelines advise healthcare professionals about the most appropriate treatment or care for people with a particular condition such as lower back pain or cancer. Informally, clinical practice guidelines have been a fundamental component of medicine since healers first discussed how best to manage patients.
The first known formal clinical guidelines may have been written by Hippocrates. Credited with advancing the systematic study of clinical medicine, he summed up medical knowledge and prescribing practices for physicians in the Hippocratic Corpus, works written for both specialists and lay people, sometimes from opposing viewpoints. This library of medical text written between the sixth and fourth centuries BCE probably contained the earliest clinical guidelines.
The modern age of guidelines began with a 1992 Institute of Medicine (IOM) report, which defines guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances.” Now there are numerous guidelines produced by medical societies (such as the American College of Cardiology) or governmental bodies (such as the Agency for Healthcare Research and Quality).
Who Participates in Clinical Guideline Groups?
The individuals appointed to devise—or update—clinical guidelines include healthcare professionals, researchers, patients and caregivers. All have specific knowledge of the clinical domain. In addition, this collaborative approach to guideline development ensures that best practices from a variety of settings and viewpoints are incorporated to produce the best outcomes for patients.
The initial development of guidelines typically includes the following steps:
- Identify and delineate the subject area (e.g., cancer, back pain)
- Convene and lead a guideline development group made up of subject-matter experts
- Assess evidence about the clinical question or condition
- Translate evidence into a recommendation
- According to the Institute of Medicine Standards for Developing Trustworthy Clinical Practice Guidelines, for each recommendation, the following should be provided:
- An explanation of the reasoning
- A rating of the level of confidence in the evidence underpinning the recommendation
- A rating of the strength of the recommendation by utilizing a scale such as the one developed by the American Academy of Family Physicians
- A description and analysis around any differing opinions regarding the recommendation
- Review the guideline by utilizing systematic reviews approved by the Institute of Medicine Committee’s Systematic Reviews of Comparative Effectiveness Research.
Guideline development groups (GDG) must have the time, resources, and skills to scrutinize evidence and make objective value judgments based on their expertise, clinical studies on the subject matter, and analysis of the medical evidence available to them. Group members must be free of conflicts of interest, and are required to declare all interests and activities resulting in any potential conflicts of interest by written disclosure to those convening the GDG. Some ideal characteristics of groups that author these clinical guidelines are that they are multidisciplinary, and gender and geographically-balanced.
The group will appoint a writer as well as a chair, who should be an expert facilitator. Many groups include a methodologist, an expert in guideline development process to ensure that the standardized articulation of recommendation is met, and an economist, who can advise on economic benefits and drawbacks of recommendations.
What Do Guidelines Include?
Guidelines include various clinical support content, such as the risk factors for conditions; diagnostic criteria; prognostics with and without treatment; the benefit and harm of various treatment options; resources associated with different diagnostic or treatment options; and patients’ experiences of the options.
The 1992 IOM report suggested that every set of clinical guidelines also include information on the cost implications of alternative, preventative, diagnostic, and management strategies for each clinical situation.
Guidelines are required to use clear language. Vague or nonspecific wording should be avoided, as clinicians may have difficulty knowing the precise contextual meaning of phrases such as “clinically appropriate” or “if necessary.” The manner in which guidelines are developed and funded must also be transparent and publicly available. As each new guideline is developed, it is important to ensure that all relevant external stakeholders have reviewed the guidelines prior to publishing.
Additionally, guidelines, created to improve patient care, must be updated as new research emerges so they do not lose their clinical relevance.