A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare. Such documents have been in use for thousands of years during the entire history of medicine. However, in contrast to previous approaches, which were often based on tradition or authority, modern medical guidelines are based on an examination of current evidence within the paradigm of evidence-based medicine. [1] [2] [3] They usually include summarized consensus statements on best practice in healthcare. A healthcare provider is obliged to know the medical guidelines of their profession, and has to decide whether to follow the recommendations of a guideline for an individual treatment. [4]
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. Then they define the most important questions related to clinical practice and identify all possible decision options and their outcomes. Some guidelines contain decision or computation algorithms to be followed. Thus, they integrate the identified decision points and respective courses of action with the clinical judgement and experience of practitioners. Many guidelines place the treatment alternatives into classes to help providers in deciding which treatment to use.
Additional objectives of clinical guidelines are to standardize medical care, to raise quality of care, to reduce several kinds of risk (to the patient, to the healthcare provider, to medical insurers and health plans) and to achieve the best balance between cost and medical parameters such as effectiveness, specificity, sensitivity, resoluteness, etc. It has been demonstrated repeatedly that the use of guidelines by healthcare providers such as hospitals is an effective way of achieving the objectives listed above, although they are not the only ones.
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. Local healthcare providers may produce their own set of guidelines or adapt them from existing top-level guidelines. Healthcare payers such as insurers practicing utilization management also publish guidelines. [5]
Special computer software packages known as guideline execution engines have been developed to facilitate the use of medical guidelines in concert with an electronic medical record system. The Guideline Interchange Format (GLIF) is a computer representation format for clinical guidelines that can be used with such engines. [6]
The US and other countries maintain medical guideline clearinghouses. In the US, the National Guideline Clearinghouse maintains a catalog of high-quality guidelines published by various health and medical associations. In the United Kingdom, clinical practice guidelines are published primarily by the National Institute for Health and Care Excellence (NICE). In The Netherlands, two bodies—the Institute for Healthcare Improvement (CBO) and College of General Practitioners (NHG)—have published specialist and primary care guidelines, respectively. In Germany, the German Agency for Quality in Medicine (ÄZQ) coordinates a national program for disease management guidelines. All these organisations are now members of the Guidelines International Network (G-I-N), an international network of organisations and individuals involved in clinical practice guidelines.
Checklists have been used in medical practice to attempt to ensure that clinical practice guidelines are followed. An example is the Surgical Safety Checklist developed for the World Health Organization by Dr. Atul Gawande. [7] According to a meta-analysis after introduction of the checklist mortality dropped by 23% and all complications by 40%, but further high-quality studies are required to make the meta-analysis more robust. [8] In the UK, a study on the implementation of a checklist for provision of medical care to elderly patients admitting to hospital found that the checklist highlighted limitations with frailty assessment in acute care and motivated teams to review routine practices, but that work is needed to understand whether and how checklists can be embedded in complex multidisciplinary care. [9]
Guidelines may lose their clinical relevance as they age and newer research emerges. [10] Even 20% of strong recommendations, especially when based on opinion rather than trials, from practice guidelines may be retracted. [11]
The New York Times reported in 2004 that some simple clinical practice guidelines are not routinely followed to the extent they might be. [12] It has been found that providing a nurse or other medical assistant 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.
Guidelines may have both methodological problems and conflict of interest. [13] As such, the quality of guidelines may vary substantially, especially for guidelines that are published on-line and have not had to follow methodological reporting standards often required by reputable clearinghouses. [14] Patients and caregivers are frequently excluded from clinical guidelines development, in part because there is a lack of guidance for how to include them in the process. [15]
Guidelines may make recommendations that are stronger than the supporting evidence. [16]
In response to many of these problems with traditional guidelines, the BMJ created a new series of trustworthy guidelines focused on the most pressing medical issues called BMJ Rapid Recommendations. [17]
Evidence-based medicine (EBM) is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients." The aim of EBM is to integrate the experience of the clinician, the values of the patient, and the best available scientific information to guide decision-making about clinical management. The term was originally used to describe an approach to teaching the practice of medicine and improving decisions by individual physicians about individual patients.
A randomized controlled trial is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments.
In a physical examination, medical examination, or clinical examination, a medical practitioner examines a patient for any possible medical signs or symptoms of a medical condition. It generally consists of a series of questions about the patient's medical history followed by an examination based on the reported symptoms. Together, the medical history and the physical examination help to determine a diagnosis and devise the treatment plan. These data then become part of the medical record.
A medical error is a preventable adverse effect of care ("iatrogenesis"), whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome, behavior, infection, or other ailment.
A systematic review is a scholarly synthesis of the evidence on a clearly presented topic using critical methods to identify, define and assess research on the topic. A systematic review extracts and interprets data from published studies on the topic, then analyzes, describes, critically appraises and summarizes interpretations into a refined evidence-based conclusion. For example, a systematic review of randomized controlled trials is a way of summarizing and implementing evidence-based medicine.
Gordon Henry Guyatt is a Canadian physician who is Distinguished University Professor in the Departments of Health Research Methods, Evidence and Impact and Medicine at McMaster University in Hamilton, Ontario. He is known for his leadership in evidence-based medicine, a term that first appeared in a single-author paper he published in 1991. Subsequently, a 1992 JAMA article that Guyatt led proved instrumental in bringing the concept of evidence-based medicine to the world's attention.[2] In 2007, The BMJ launched an international election for the most important contributions to healthcare. Evidence-based medicine came 7th, ahead of the computer and medical imaging. [3][4] Guyatt's concerns with the role of the medical system, social justice, and medical reform remain central issues that he promoted in tandem with his medical work. On October 9, 2015, he was named to the Canadian Medical Hall of Fame.
Pharmacotherapy, also known as pharmacological therapy or drug therapy, is defined as medical treatment that utilizes one or more pharmaceutical drugs to improve on-going symptoms, treat the underlying condition, or act as a prevention for other diseases (prophylaxis).
A hierarchy of evidence, comprising levels of evidence (LOEs), that is, evidence levels (ELs), is a heuristic used to rank the relative strength of results obtained from experimental research, especially medical research. There is broad agreement on the relative strength of large-scale, epidemiological studies. More than 80 different hierarchies have been proposed for assessing medical evidence. The design of the study and the endpoints measured affect the strength of the evidence. In clinical research, the best evidence for treatment efficacy is mainly from meta-analyses of randomized controlled trials (RCTs). Systematic reviews of completed, high-quality randomized controlled trials – such as those published by the Cochrane Collaboration – rank the same as systematic review of completed high-quality observational studies in regard to the study of side effects. Evidence hierarchies are often applied in evidence-based practices and are integral to evidence-based medicine (EBM).
Defensive medicine, also called defensive medical decision making, refers to the practice of recommending a diagnostic test or medical treatment that is not necessarily the best option for the patient, but mainly serves to protect the physician against the patient as potential plaintiff. Defensive medicine is a reaction to the rising costs of malpractice insurance premiums and patients’ biases on suing for missed or delayed diagnosis or treatment but not for being overdiagnosed.
Patient safety is a discipline that emphasizes safety in health care through the prevention, reduction, reporting and analysis of error and other types of unnecessary harm that often lead to adverse patient events. The frequency and magnitude of avoidable adverse events, often known as patient safety incidents, experienced by patients was not well known until the 1990s, when multiple countries reported significant numbers of patients harmed and killed by medical errors. Recognizing that healthcare errors impact 1 in every 10 patients around the world, the World Health Organization (WHO) calls patient safety an endemic concern. Indeed, patient safety has emerged as a distinct healthcare discipline supported by an immature yet developing scientific framework. There is a significant transdisciplinary body of theoretical and research literature that informs the science of patient safety with mobile health apps being a growing area of research.
David Lawrence Sackett was an American-Canadian physician and a pioneer in evidence-based medicine. He is known as one of the fathers of Evidence-Based Medicine. He founded the first department of clinical epidemiology in Canada at McMaster University, and the Oxford Centre for Evidence-Based Medicine. He is well known for his textbooks Clinical Epidemiology and Evidence-Based Medicine.
The Users’ Guides to the Medical Literature is a series of articles originally published in the Journal of the American Medical Association, later rewritten and compiled in a textbook, now in its third edition. The guides provide practical, clinician-friendly advice on all aspects of evidence-based medicine.
Health information technology (HIT) is health technology, particularly information technology, applied to health and health care. It supports health information management across computerized systems and the secure exchange of health information between consumers, providers, payers, and quality monitors. Based on a 2008 report on a small series of studies conducted at four sites that provide ambulatory care – three U.S. medical centers and one in the Netherlands, the use of electronic health records (EHRs) was viewed as the most promising tool for improving the overall quality, safety and efficiency of the health delivery system.
In economics, supplier induced demand (SID) may occur when asymmetry of information exists between supplier and consumer. The supplier can use superior information to encourage an individual to demand a greater quantity of the good or service they supply than the Pareto efficient level, should asymmetric information not exist. The result of this is a welfare loss.
Shared decision-making in medicine (SDM) is a process in which both the patient and physician contribute to the medical decision-making process and agree on treatment decisions. Health care providers explain treatments and alternatives to patients and help them choose the treatment option that best aligns with their preferences as well as their unique cultural and personal beliefs.
David M. Eddy is an American physician, mathematician, and healthcare analyst who has done seminal work in mathematical modeling of diseases, clinical practice guidelines, and evidence-based medicine. Four highlights of his career have been summarized by the Institute of Medicine of the National Academy of Sciences: "more than 25 years ago, Eddy wrote the seminal paper on the role of guidelines in medical decision-making, the first Markov model applied to clinical problems, and the original criteria for coverage decisions; he was the first to use and publish the term 'evidence-based'."
Alessandro Liberati was an Italian healthcare researcher and clinical epidemiologist, and founder of the Italian Cochrane Centre.
Choosing Wisely is a United States-based health educational campaign, led by the ABIM Foundation, about unnecessary health care.
Health care quality is a level of value provided by any health care resource, as determined by some measurement. As with quality in other fields, it is an assessment of whether something is good enough and whether it is suitable for its purpose. The goal of health care is to provide medical resources of high quality to all who need them; that is, to ensure good quality of life, cure illnesses when possible, to extend life expectancy, and so on. Researchers use a variety of quality measures to attempt to determine health care quality, including counts of a therapy's reduction or lessening of diseases identified by medical diagnosis, a decrease in the number of risk factors which people have following preventive care, or a survey of health indicators in a population who are accessing certain kinds of care.
The GRADE approach is a method of assessing the certainty in evidence and the strength of recommendations in health care. It provides a structured and transparent evaluation of the importance of outcomes of alternative management strategies, acknowledgment of patients and the public values and preferences, and comprehensive criteria for downgrading and upgrading certainty in evidence. It has important implications for those summarizing evidence for systematic reviews, health technology assessments, and clinical practice guidelines as well as other decision makers.