GRADE approach

Last updated

The GRADE approach (Grading of Recommendations Assessment, Development and Evaluation) is a method of assessing the certainty in evidence (also known as quality of evidence or confidence in effect estimates) and the strength of recommendations in health care. [1] 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. [2]

Contents

Background and history

The GRADE began in the year 2000 as a collaboration of methodologists, guideline developers, biostatisticians, clinicians, public health scientists and other interested members. GRADE developed and implemented a common, transparent and sensible approach to grading the quality of evidence (also known as certainty in evidence or confidence in effect estimates) and strength of recommendations in healthcare. [3] [4]

GRADE components

The GRADE approach separates recommendations following from an evaluation of the evidence as strong or weak. A recommendation to use, or not use an option (e.g. an intervention), should be based on the trade-offs between desirable consequences of following a recommendation on the one hand, and undesirable consequences on the other. If desirable consequences outweigh undesirable consequences, decision makers will recommend an option and vice versa. The uncertainty associated with the trade-off between the desirable and undesirable consequences will determine the strength of recommendations. [5] The criteria that determine this balance of consequences are listed in Table 2. Furthermore, it provides decision-makers (e.g. clinicians, other health care providers, patients and policy makers) with a guide to using those recommendations in clinical practice, public health and policy. To achieve simplicity, the GRADE approach classifies the quality of evidence in one of four levels—high, moderate, low, and very low:

Quality of evidence

GRADE rates quality of evidence as follows: [6] [7]

HighThere is a lot of confidence that the true effect lies close to that of the estimated effect.
ModerateThere is moderate confidence in the estimated effect: The true effect is likely to be close to the estimated effect, but there is a possibility that it is substantially different.
LowThere is limited confidence in the estimated effect: The true effect might be substantially different from the estimated effect.
Very lowThere is very little confidence in the estimated effect: The true effect is likely to be substantially different from the estimated effect.

The GRADE working group has developed a software application that facilitates the use of the approach, allows the development of summary tables and contains the GRADE handbook. The software is free for non-profit organizations and is available online. [8] The GRADE approach to assess the certainty in evidence is widely applicable, including to questions about diagnosis, [9] [10] prognosis, [11] [12] network meta-analysis [13] and public health. [14]

Strength of recommendation

Factors and criteria that determine the direction and strength of a recommendation:

Factor and criteria*How the factor influences the direction and strength of a recommendation
Problem

This factor can be integrated with the balance of the benefits and harms and burden.

The problem is determined by the importance and frequency of the health care issue that is addressed (burden of disease, prevalence or baseline risk). If the problem is of great importance a strong recommendation is more likely.
Values and preferencesThis describes how important health outcomes are to those affected, how variable they are and if there is uncertainty about this. The less variability or uncertainty there is about values and preferences for the critical or important outcomes, the more likely is a strong recommendation.
Quality of the evidenceThe confidence in any estimate of the criteria determining the direction and strength of the recommendation will determine if a strong or conditional recommendation is offered. However, the overall quality that is assigned to the recommendation is that of the evidence about effects on population-important outcomes. The higher the quality of evidence the more likely is a strong recommendation.
Benefits and harms and burdenThis requires an evaluation of the absolute effects of both the benefits and harms and their importance. The greater the net benefit or net harm the more likely is a strong recommendation for or against the option.
Resource implicationsThis describes how resource intense an option is, if it is cost-effective and if there is incremental benefit. The more advantageous or clearly disadvantageous these resource implications are the more likely is a strong recommendation.
Equity

This factor is often addressed under values preferences, and frequently also includes resource considerations

The greater the likelihood to reduce inequities or increase equity and the more accessible an option is, the more likely is a strong recommendation.
Acceptability

This factor can be integrated with the balance of the benefits and harms and burden.

The greater the acceptability of an option to all or most stakeholders, the more likely is a strong recommendation.
Feasibility

This factor includes considerations about values and preferences, and resource implications.

The greater the acceptability of an option to all or most stakeholders, the more likely is a strong recommendation.

Usage

Over 100 organizations (including the World Health Organization, [15] the UK National Institute for Health and Care Excellence (NICE), the Canadian Task Force for Preventive Health Care, the Colombian Ministry of Health and Social Protection,[ citation needed ] and the Saudi Arabian Ministry of Health [16] ) have endorsed and/or are using GRADE to evaluate the quality of evidence and strength of health care recommendations.[ citation needed ]

Criticism

When used to summarize evidence from nutritional science, dietary, lifestyle, and environmental exposure, the use of the GRADE approach has been criticized. That is because the GRADE system only allows for randomized controlled trials (RCT) to be rated as high evidence and rates all observational studies as low evidence because of their potential for confounding. This dismisses the strength of observational studies when it comes to long-term effects of dietary and lifestyle factors and does not reflect the key limitations that RCTs have when it comes to long-term effects. [17] [18] One example of a slowly progressing disease that should preferably be studied with observational studies but not RCTs is atherosclerosis. [19]

Related Research Articles

Evidence-based medicine (EBM) is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. ... [It] means integrating individual clinical expertise with the best available external clinical evidence from systematic research." 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.

<span class="mw-page-title-main">Arthroscopy</span> Examination of a joint via small surgical incision

Arthroscopy is a minimally invasive surgical procedure on a joint in which an examination and sometimes treatment of damage is performed using an arthroscope, an endoscope that is inserted into the joint through a small incision. Arthroscopic procedures can be performed during ACL reconstruction.

<span class="mw-page-title-main">Sore throat</span> Medical condition

Sore throat, also known as throat pain, is pain or irritation of the throat. Usually, causes of sore throat include:

<span class="mw-page-title-main">Medical guideline</span> Document with the aim of guiding decisions and criteria in healthcare

A medical 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. 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.

<span class="mw-page-title-main">Systematic review</span> Comprehensive review of research literature using systematic methods

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.

<span class="mw-page-title-main">Gordon Guyatt</span> Canadian physician

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.

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).

In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases. Case reports are professional narratives that provide feedback on clinical practice guidelines and offer a framework for early signals of effectiveness, adverse events, and cost. They can be shared for medical, scientific, or educational purposes.

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.

Consolidated Standards of Reporting Trials (CONSORT) encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials. It is part of the larger EQUATOR Network initiative to enhance the transparency and accuracy of reporting in research.

<i>Users Guides to the Medical Literature</i> Book by Gordon Guyatt and Drummond Rennie

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.

Critical appraisal in evidence based medicine, is the use of explicit, transparent methods to assess the data in published research, applying the rules of evidence to factors such as internal validity, adherence to reporting standards, conclusions, generalizability and risk-of-bias. Critical appraisal methods form a central part of the systematic review process. They are used in evidence synthesis to assist clinical decision-making, and are increasingly used in evidence-based social care and education provision.

The Bradford Hill criteria, otherwise known as Hill's criteria for causation, are a group of nine principles that can be useful in establishing epidemiologic evidence of a causal relationship between a presumed cause and an observed effect and have been widely used in public health research. They were established in 1965 by the English epidemiologist Sir Austin Bradford Hill.

Evidence-based dentistry (EBD) is the dental part of the more general movement toward evidence-based medicine and other evidence-based practices. The pervasive access to information on the internet includes different aspects of dentistry for both the dentists and patients. This has created a need to ensure that evidence referenced to are valid, reliable and of good quality.

Alessandro Liberati was an Italian healthcare researcher and clinical epidemiologist, and founder of the Italian Cochrane Centre.

The minimal important difference (MID) or minimal clinically important difference (MCID) is the smallest change in a treatment outcome that an individual patient would identify as important and which would indicate a change in the patient's management.

Holger Jens Schünemann is a physician and professor of Preventive Medicine and Public Health and professor emeritus of medicine and Clinical epidemiology. Since 1 December 2023 he is Director of the Clinical Epidemiology and Research Center (CERC) at Humanitas University. From 1 February 2009 to 30 June 2019 he was the chair of the Department of Health Research Methods, Evidence, and Impact at McMaster University in Hamilton, Canada, where he now works as full professor.

A fact box is a simplified display format that presents evidence based data about the benefits and harms of medical treatments, screenings or interventions.

Benjamin Djulbegovic is an American physician-scientist whose academic and research focus revolves around optimizing clinical research and the practice of medicine by comprehending the nature of medical evidence and decision-making. In his work, he has integrated concepts from evidence-based medicine (EBM), predictive analytics, health outcomes research, and the decision sciences.

References

  1. ↑ Schünemann, HJ; Best, D; Vist, G; Oxman, AD (2003). "Letters, numbers, symbols, and words: How best to communicate grades of evidence and recommendations?". Canadian Medical Association Journal. 169 (7): 677–80.
  2. ↑ Guyatt, GH; Oxman, AD; Vist, GE; Kunz, R; Falck-Ytter, Y; Alonso-Coello, P; Schünemann, HJ (2008). "GRADE: an emerging consensus on rating quality of evidence and strength of recommendation". BMJ. 336 (7650): 924–26. doi:10.1136/bmj.39489.470347.ad. PMC   2335261 . PMID   18436948.
  3. ↑ Guyatt, GH; Oxman, AD; Schünemann, HJ; Tugwell, P; Knotterus, A (2011). "GRADE guidelines: A new series of articles in the Journal of Clinical Epidemiology". Journal of Clinical Epidemiology. 64 (4): 380–382. doi:10.1016/j.jclinepi.2010.09.011. PMID   21185693.
  4. ↑ "GRADE home". Gradeworkinggroup.org. Retrieved 16 August 2019.
  5. ↑ Andrews, J; Guyatt, GH; Oxman, AD; Alderson, P; Dahm, P; Falck-Ytter, Y; Nasser, M; Meerpohl, J; Post, PN; Kunz, R; Brozek, J; Vist, G; Rind, D; Akl, EA; Schünemann, HJ (2013). "GRADE guidelines: 15. Going from evidence to recommendations: the significance and presentation of recommendations". Journal of Clinical Epidemiology. 66 (7): 719–725. doi:10.1016/j.jclinepi.2012.03.013. PMID   23312392.
  6. ↑ Balshem, H; Helfand, M; Schünemann, HJ; Oxman, AD; Kunz, R; Brozek, J; Vist, GE; Falck-Ytter, Y; Meerpohl, J; Norris, S; Guyatt, GH (April 2011). "GRADE guidelines 3: rating the quality of evidence - introduction". Journal of Clinical Epidemiology. 64 (4): 401–406. doi: 10.1016/j.jclinepi.2010.07.015 . PMID   21208779.
  7. ↑ Reed Siemieniuk and Gordon Guyatt. "What is GRADE?". BMJ Best Practice. Retrieved 2020-07-02.
  8. ↑ "GRADEpro". Gradepro.org. Retrieved 16 August 2019.
  9. ↑ Schünemann, HJ; Oxman, AD; Brozek, J; Glasziou, P; Jaeschke, R; Vist, G; Williams, J; Kunz, R; Craig, J; Montori, V; Bossuyt, P; Guyatt, GH (2008). "GRADEing the quality of evidence and strength of recommendations for diagnostic tests and strategies". BMJ. 336 (7653): 1106–1110. doi:10.1136/bmj.39500.677199.ae. PMC   2386626 . PMID   18483053.
  10. ↑ Brozek, JL; Akl, EA; Jaeschke, R; Lang, DM; Bossuyt, P; Glasziou, P; Helfand, M; Ueffing, E; Alonso-Coello, P; Meerpohl, J; Phillips, B; Horvath, AR; Bousquet, J; Guyatt, GH; Schünemann, HJ (2009). "Grading quality of evidence and strength of recommendations in clinical practice guidelines: part 2 of 3. The GRADE approach to grading quality of evidence about diagnostic tests and strategies". Allergy. 64 (8): 1109–16. doi: 10.1111/j.1398-9995.2009.02083.x . PMID   19489757. S2CID   8865010.
  11. ↑ Iorio, A; Spencer, FA; Falavigna, M; Alba, C; Lang, E; Burnand, B; McGinn, T; Hayden, J; Williams, K; Shea, B; Wolff, R; Kujpers, T; Perel, P; Vandvik, PO; Glasziou, P; Schünemann, H; Guyatt, G (2015). "Use of GRADE for assessment of evidence about prognosis: rating confidence in estimates of event rates in broad categories of patients". BMJ. 350: h870. doi: 10.1136/bmj.h870 . PMID   25775931.
  12. ↑ Spencer, FA; Iorio, A; You, J; Murad, MH; Schünemann, HJ; Vandvik, PO; Crowther, MA; Pottie, K; Lang, ES; Meerpohl, JJ; Falck-Ytter, Y; Alonso-Coello, P; Guyatt, GH (2012). "Uncertainties in baseline risk estimates and confidence in treatment effects". BMJ. 14: 345. doi: 10.1136/bmj.e7401 . PMID   23152569.
  13. ↑ Puhan, MA; Schünemann, HJ; Murad, MH; Li, T; Brignardello-Petersen, R; Singh, JA; Kessels, AG; Guyatt, GH (2014). "A GRADE Working Group approach for rating the quality of treatment effect estimates from network meta-analysis". BMJ. 24: 349. doi: 10.1136/bmj.g5630 . PMID   25252733.
  14. ↑ Burford, BJ; Rehfuess, E; Schünemann, HJ; Akl, EA; Waters, E; Armstrong, R; Thomson, H; Doyle, J; Pettman, T (2012). "Assessing evidence in public health: the added value of GRADE". J Public Health. 34 (4): 631–5. doi: 10.1093/pubmed/fds092 . PMID   23175858.
  15. ↑ "GRADEpro". Gradepro.org. Retrieved 16 August 2019.
  16. ↑ "The Saudi Center for Evidence Based Healthcare (EBHC) - Clinical Practice Guidelines". 2016-02-25. Archived from the original on 2016-02-25. Retrieved 2021-02-19.
  17. ↑ Qian, Frank; Riddle, Matthew C.; Wylie-Rosett, Judith; Hu, Frank B. (2020-01-13). "Red and Processed Meats and Health Risks: How Strong Is the Evidence?". Diabetes Care. 43 (2): 265–271. doi:10.2337/dci19-0063. ISSN   0149-5992. PMC   6971786 . S2CID   210841441.
  18. ↑ Parker-Pope, Tara; O’Connor, Anahad (2019-10-04). "Scientist Who Discredited Meat Guidelines Didn't Report Past Food Industry Ties". The New York Times. ISSN   0362-4331 . Retrieved 2022-01-05.
  19. ↑ Gan, Zuo Hua; Cheong, Huey Chiat; Tu, Yu-Kang; Kuo, Po-Hsiu (2021-11-05). "Association between Plant-Based Dietary Patterns and Risk of Cardiovascular Disease: A Systematic Review and Meta-Analysis of Prospective Cohort Studies". Nutrients. 13 (11): 3952. doi: 10.3390/nu13113952 . ISSN   2072-6643. PMC   8624676 . PMID   34836208.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.