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Hierarchy of evidence

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description of the intervention. This protocol does not consider the nature of any comparison group, the effect of confounding variables, the nature of the statistical analysis, or a number of other criteria. Interventions are assessed as belonging to Category 1, well-supported, efficacious treatments, if there are two or more randomized controlled outcome studies comparing the target treatment to an appropriate alternative treatment and showing a significant advantage to the target treatment. Interventions are assigned to Category 2, supported and probably efficacious treatment, based on positive outcomes of nonrandomized designs with some form of control, which may involve a non-treatment group. Category 3, supported and acceptable treatment, includes interventions supported by one controlled or uncontrolled study, or by a series of single-subject studies, or by work with a different population than the one of interest. Category 4, promising and acceptable treatment, includes interventions that have no support except general acceptance and clinical anecdotal literature; however, any evidence of possible harm excludes treatments from this category. Category 5, innovative and novel treatment, includes interventions that are not thought to be harmful, but are not widely used or discussed in the literature. Category 6, concerning treatment, is the classification for treatments that have the possibility of doing harm, as well as having unknown or inappropriate theoretical foundations.
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protocol noted that such designs were useful only if they met demanding criteria, such as true randomization and concealment of the assigned treatment group from the client and from others, including the individuals assessing the outcome. The Khan et al. protocol emphasized the need to make comparisons on the basis of "intention to treat" in order to avoid problems related to greater attrition in one group. The Khan et al. protocol also presented demanding criteria for nonrandomized studies, including matching of groups on potential confounding variables and adequate descriptions of groups and treatments at every stage, and concealment of treatment choice from persons assessing the outcomes. This protocol did not provide a classification of levels of evidence, but included or excluded treatments from classification as evidence-based depending on whether the research met the stated standards.
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survive previous philosophical criticism, he argues that modest interpretations are so weak they are unhelpful for clinical practice. For example, "GRADE and similar conditional models omit clinically relevant information, such as information about variation in treatments' effects and the causes of different responses to therapy; and that heuristic approaches lack the necessary empirical support". Blunt further concludes that "hierarchies are a poor basis for the application of evidence in clinical practice", since the core assumptions behind hierarchies of evidence, that "information about average treatment effects backed by high-quality evidence can justify strong recommendations", is untenable, and hence the evidence from individuals studies should be appraised in isolation.
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published in a peer-reviewed journal or an evaluation report, and if documentation such as training materials has been made available. The NREPP evaluation, which assigns quality ratings from 0 to 4 to certain criteria, examines reliability and validity of outcome measures used in the research, evidence for intervention fidelity (predictable use of the treatment in the same way every time), levels of missing data and attrition, potential confounding variables, and the appropriateness of statistical handling, including sample size.
310: 749: 589:(CEBM) Levels of Evidence published its guidelines for 'Levels' of evidence regarding claims about prognosis, diagnosis, treatment benefits, treatment harms, and screening. It not only addressed therapy and prevention, but also diagnostic tests, prognostic markers, or harm. The original CEBM Levels was first released for Evidence-Based On Call to make the process of finding evidence feasible and its results explicit. As published in 2009 they are: 2886: 366:, the UK National Institute for Health and Care Excellence (NICE), the Canadian Task Force for Preventive Health Care, the Colombian Ministry of Health, among others) have endorsed and/or are using GRADE to evaluate the quality of evidence and strength of health care recommendations. (See examples of clinical practice guidelines using GRADE online). 644:
In 2011, an international team redesigned the Oxford CEBM Levels to make it more understandable and to take into account recent developments in evidence ranking schemes. The Levels have been used by patients, clinicians and also to develop clinical guidelines including recommendations for the optimal
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A large number of hierarchies of evidence have been proposed. Similar protocols for evaluation of research quality are still in development. So far, the available protocols pay relatively little attention to whether outcome research is relevant to efficacy (the outcome of a treatment performed under
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Atkins, D; Best, D; Briss, P. A; Eccles, M; Falck-Ytter, Y; Flottorp, S; Guyatt, G. H; Harbour, R. T; Haugh, M. C; Henry, D; Hill, S; Jaeschke, R; Leng, G; Liberati, A; Magrini, N; Mason, J; Middleton, P; Mrukowicz, J; O'Connell, D; Oxman, A. D; Phillips, B; Schünemann, H. J; Edejer, T; Varonen, H;
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In his 2015 PhD Thesis dedicated to the study of the various hierarchies of evidence in medicine, Christopher J Blunt concludes that although modest interpretations such as those offered by La Caze's model, conditional hierarchies like GRADE, and heuristic approaches as defended by Howick et al all
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A protocol suggested by Saunders et al. assigns research reports to six categories, on the basis of research design, theoretical background, evidence of possible harm, and general acceptance. To be classified under this protocol, there must be descriptive publications, including a manual or similar
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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. The GRADE began in the year 2000 as a collaboration of
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In 2014, Jacob Stegenga defined a hierarchy of evidence as "rank-ordering of kinds of methods according to the potential for that method to suffer from systematic bias". At the top of the hierarchy is a method with the most freedom from systemic bias or best internal validity relative to the tested
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Concato said in 2004, that it allowed RCTs too much authority and that not all research questions could be answered through RCTs, either because of practical or because of ethical issues. Even when evidence is available from high-quality RCTs, evidence from other study types may still be relevant.
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The CTF graded their recommendations into a 5-point A–E scale: A: Good level of evidence for the recommendation to consider a condition, B: Fair level of evidence for the recommendation to consider a condition, C: Poor level of evidence for the recommendation to consider a condition, D: Fair level
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A protocol for evaluation of research quality was suggested by a report from the Centre for Reviews and Dissemination, prepared by Khan et al. and intended as a general method for assessing both medical and psychosocial interventions. While strongly encouraging the use of randomized designs, this
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An assessment protocol has been developed by the U.S. National Registry of Evidence-Based Practices and Programs (NREPP). Evaluation under this protocol occurs only if an intervention has already had one or more positive outcomes, with a probability of less than .05, reported, if these have been
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note, that EBM limits the ability of research results to inform the care of individual patients, and that to understand the causes of diseases both population-level and laboratory research are necessary. EBM hierarchy of evidence does not take into account research on the safety and efficacy of
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The term was first used in a 1979 report by the "Canadian Task Force on the Periodic Health Examination" (CTF) to "grade the effectiveness of an intervention according to the quality of evidence obtained". The task force used three levels, subdividing level II:
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The hierarchy of evidence produced by a study design has been questioned, because guidelines have "failed to properly define key terms, weight the merits of certain non-randomized controlled trials, and employ a comprehensive list of study design limitations".
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In 2011, a systematic review of the critical literature found three kinds of criticism: procedural aspects of EBM (especially from Cartwright, Worrall and Howick), greater than expected fallibility of EBM (Ioaanidis and others), and EBM being incomplete as a
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medical interventions. RCTs should be designed "to elucidate within-group variability, which can only be done if the hierarchy of evidence is replaced by a network that takes into account the relationship between epidemiological and laboratory research"
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Lim, Stephen S; Vos, Theo; Flaxman, Abraham D; Danaei, Goodarz; Shibuya, Kenji; Adair-Rohani, Heather; Almazroa, Mohammad A; Amann, Markus; Anderson, H Ross; Andrews, Kathryn G; Aryee, Martin; Atkinson, Charles; Bacchus, Loraine J; Bahalim, Adil N;
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Wilson, Mark C (1995). "Users' guides to the medical literature. VIII. How to use clinical practice guidelines. B. what are the recommendations and will they help you in caring for your patients? The evidence-based medicine working group".
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Stegenga has criticized specifically that meta-analyses are placed at the top of such hierarchies. The assumption that RCTs ought to be necessarily near the top of such hierarchies has been criticized by Worrall and Cartwright.
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Guyatt GH, Sackett DL, Sinclair JC, Hayward R, Cook DJ, Cook RJ (December 1995). "Users' guides to the medical literature. IX. A method for grading health care recommendations. Evidence-Based Medicine Working Group".
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Paul, C.; Gallini, A.; Archier, E.; et al. (2012). "Evidence-Based Recommendations on Topical Treatment and Phototherapy of Psoriasis: Systematic Review and Expert Opinion of a Panel of Dermatologists".
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evidence for the recommendation to exclude the condition, and E: Good level of evidence for the recommendation to exclude condition from consideration. The CTF updated their report in 1984, in 1986 and 1987.
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Khan, K.S., et al. (2001). CRD Report 4. Stage II. Conducting the review. phase 5. Study quality assessment. York, UK: Centre for Reviews and Dissemination, University of York. Retrieved July 20, 2007 from
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medical intervention's hypothesized efficacy. In 1997, Greenhalgh suggested it was "the relative weight carried by the different types of primary study when making decisions about clinical interventions".
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1c: All or none (when all patients died before the treatment became available, but some now survive on it; or when some patients died before the treatment became available, but none now die on it.)
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World Cancer Research Fund AICR. Food, Nutrition, and Physical Activity, and the Prevention of Cancer: A Global Perspective. American Institute for Cancer Research, Washington, DC; 2007
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There 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.
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RCTs with non-definitive results (a point estimate that suggests a clinically significant effect but with confidence intervals overlapping the threshold for this effect)
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Gugiu, PC; Westine, CD; Coryn, CL; Hobson, KA (3 April 2012). "An application of a new evidence grading system to research on the chronic care model".
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Saunders, B., Berliner, L., & Hanson, R. (2004). Child physical and sexual abuse: Guidelines for treatments. Retrieved September 15, 2006, from
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justify them, but that "medical researchers should pay closer attention to social mechanisms for managing pervasive biases". La Caze noted that
1139:; Best, D; Vist, G; Oxman, AD (2003). "Letters, numbers, symbols, and words: How best to communicate grades of evidence and recommendations?". 901:"Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview" 1429:
Canadian Task Force on the Periodic Health Examination (15 May 1986). "Task Force Report: The periodic health examination. 3. 1986 update".
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There is very little confidence in the estimated effect: The true effect is likely to be substantially different from the estimated effect.
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Hadorn, David C; Baker, David; Hodges, James S; Hicks, Nicholas (1996). "Rating the quality of evidence for clinical practice guidelines".
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Stegenga opined that evidence assessment schemes are unreasonably constraining and less informative than other schemes now available.
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In 1995 Wilson et al., in 1996 Hadorn et al. and in 1996 Atkins et al. have described and defended various types of grading systems.
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resides on the lower tiers of EBM though it "plays a role in specifying experiments, but also analysing and interpreting the data."
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designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
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Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
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There is limited confidence in the estimated effect: The true effect might be substantially different from the estimated effect.
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Level III: Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees.
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methodologists, guideline developers, biostatisticians, clinicians, public health scientists and other interested members.
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Shafee, Thomas; Masukume, Gwinyai; Kipersztok, Lisa; Das, Diptanshu; Häggström, Mikael; Heilman, James (28 August 2017).
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National Registry of Evidence-Based Practices and Programs (2007). NREPP Review Criteria. Retrieved March 10, 2008 from
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ideal conditions) or to effectiveness (the outcome of the treatment performed under ordinary, expectable conditions).
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RCTs with definitive results (confidence intervals that do not overlap the threshold clinically significant effect)
2457: 537:(USPSTF) came out with its guidelines based on the CTF using the same three levels, further subdividing level II. 2232: 793: 2901: 2247: 2193: 1974: 666: 2586: 84: 1205:; Oxman, AD; Kunz, R; Brozek, J; Vist, GE; Falck-Ytter, Y; Meerpohl, J; Norris, S; Guyatt, GH (April 2011). 2716: 2680: 2675: 2551: 1922: 542: 500: 249: 233: 112: 1247: 2932: 2611: 2571: 662: 142: 122: 2626: 2621: 2581: 2546: 2184:(Autumn 2005). "Looking for rules in a world of exceptions: reflections on evidence-based practice". 2026: 721:
Borgerson in 2009 wrote that the justifications for the hierarchy levels are not absolute and do not
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said that EBM claims to be a normative guide to being a better physician, but is not a philosophical
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grading system described 4 levels: Convincing, probable, possible and insufficient evidence. All
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2b: Individual cohort study or low quality randomized controlled trials (e.g. <80% follow-up)
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There is a lot of confidence that the true effect lies close to that of the estimated effect.
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of completed, high-quality randomized controlled trials – such as those published by the
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Guide to clinical preventive services: report of the U.S. Preventive Services Task Force
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Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU)
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The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach
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Golder, Su; Loke, Yoon K.; Bland, Martin (2011-05-03). Vandenbroucke, Jan P. (ed.).
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and guidelines for the use of the BCLC staging system for diagnosing and monitoring
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La Caze A (January 2011). "The role of basic science in evidence-based medicine".
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have used it to evaluate epidemiologic evidence supporting causal relationships.
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without explicit critical appraisal, or based on physiology, bench research or "
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Level II2: Comparisons between times and places with or without the intervention
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Systematic database of 195 hierarchies of evidence in medicine up to 08/10/2020
1860: 1008:"How to read a paper. Getting your bearings (deciding what the paper is about)" 754: 633: 436: 309: 289: 285: 2304: 2233:"Valuing evidence: bias and the evidence hierarchy of evidence-based medicine" 2159: 1884: 1801: 978: 221:. More than 80 different hierarchies have been proposed for assessing medical 2911: 2742: 2737: 2665: 2035: 1545:"Oxford Centre for Evidence-based Medicine – Levels of Evidence (March 2009)" 1158: 1023: 926: 842: 834: 726: 549: 424: 245: 2469: 2347: 416:
Greenhalgh put the different types of primary study in the following order:
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Level II-1: Evidence obtained from well-designed controlled trials without
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Canadian Task Force on the Periodic Health Examination (3 November 1979).
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analytic studies, preferably from more than one center or research group.
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Canadian Task Force on the Periodic Health Examination (1 April 1988).
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Canadian Task Force on the Periodic Health Examination (15 May 1984).
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Vist, G. E; Williams Jr, J. W; Zaza, S; GRADE Working Group (2004).
1450:"Task Force Report: The periodic health examination. 2. 1987 update" 1390:"Task Force Report: The periodic health examination. 2. 1984 update" 962: 878:(3rd ed.). Edinburgh: Churchill Livingstone. pp. 102–105. 819:"Evolution of Knowledge's medical content: past, present and future" 217:. There is broad agreement on the relative strength of large-scale, 2117: 2104:
Worrall, John (2002). "What Evidence in Evidence-Based Medicine?".
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Burns, Patricia B.; Rohrich, Rod J.; Chung, Kevin C. (July 2011).
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3a: Systematic review (with homogeneity) of case-control studies
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In 1995, Guyatt and Sackett published the first such hierarchy.
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Level I: Evidence obtained from at least one properly designed
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U.S. National Registry of Evidence-Based Practices and Programs
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Journal of the European Academy of Dermatology and Venereology
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Over the years many more grading systems have been described.
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Canadian Agency for Drugs and Technologies in Health (CADTH)
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2a: Systematic reviews (with homogeneity) of cohort studies
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used to describe the strength of the results measured in a
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1b: Individual randomized controlled trials (with narrow
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National Institute for Health and Care Excellence (NICE)
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Straus SE, Richardson WS, Glasziou P, Haynes RB (2005).
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Evidence-based Medicine: How to Practice and Teach EBM
2067:"Is meta-analysis the platinum standard of evidence?" 1782: 1349:"Task Force Report: The periodic health examination" 1057:"NCI Dictionary of Cancer Terms: Levels of evidence" 744: 506:
Level II1: Evidence from at least one well designed
1649: 1582:OCEBM Levels of Evidence Working Group (May 2016). 1482: 2382:Hierarchies of evidence in evidence-based medicine 1596: 629:(and poor quality cohort and case-control studies) 597:(with homogeneity) of randomized controlled trials 236:) and the endpoints measured (such as survival or 2807:Agency for Healthcare Research and Quality (AHRQ) 2460:– entry in the Centre for Evidence-Based Medicine 1519:"Levels of evidence and analyzing the literature" 911:(5). Public Library of Science (PLoS): e1001026. 555:Level II-2: Evidence obtained from well-designed 2909: 2602:Evidence-based pharmacy in developing countries 2577:Evidence-based library and information practice 1333:http://www.nrepp.samsha.gov/review-criteria.htm 1321:http://www.york.ac.uk/inst/crd/pdf/crd_4ph5.pdf 898: 209:the relative strength of results obtained from 2837:WHO Evidence-Informed Policy Network (EVIPNet) 2491: 1832: 1071: 369:GRADES rates quality of evidence as follows: 162: 2822:German Agency for Quality in Medicine (AEZQ) 2372: 1489:U.S. Preventive Services Task Force (1989). 823:Journal of Epidemiology and Community Health 566:Level II-3: Evidence obtained from multiple 535:United States Preventive Services Task Force 331:Canadian Association of Pharmacy in Oncology 2505: 2404: 1569: 645:use of phototherapy and topical therapy in 616:2c: "Outcomes" Research; ecological studies 337:Example hierarchies of evidence in medicine 2498: 2484: 2472:by Christopher J Blunt for his PhD Thesis. 2138: 1869:European Journal for Philosophy of Science 1002: 956: 954: 240:) affect the strength of the evidence. 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The design of the study (such as a 2853:Centre for Reviews and Dissemination 2240:Perspectives in Biology and Medicine 2186:Perspectives in Biology and Medicine 1967:Perspectives in Biology and Medicine 1141:Canadian Medical Association Journal 1100: 993: 499:Level I: Evidence from at least one 1246:Reed Siemieniuk and Gordon Guyatt. 585:In September 2000, the Oxford (UK) 24: 2412:Plastic and Reconstructive Surgery 1584:"The Oxford Levels of Evidence 2'" 1549:Centre for Evidence-Based Medicine 1495:. 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The 266:evidence-based medicine 219:epidemiological studies 2891:public domain material 2791:Science-Based Medicine 2786:Campbell Collaboration 2781:Cochrane Collaboration 2597:Evidence-based nursing 258:Cochrane Collaboration 2617:Evidence-based policy 2562:Evidence-based design 2526:Hierarchy of evidence 2202:10.1353/pbm.2005.0098 2106:Philosophy of Science 1983:10.1353/pbm.2005.0082 1653:Balakrishnan, Kalpana 688:philosophy of science 213:research, especially 183:hierarchy of evidence 2065:Stegenga, J (2011). 442:Case–control studies 316:Procter & Gamble 264:and are integral to 2776:James Lind Alliance 1667:(9859): 2224–2260. 1118:on 21 February 2016 602:confidence interval 294:design of the study 2542:Effective altruism 2256:10.1353/pbm.0.0086 1083:www.dentalcare.com 595:Systematic reviews 512:case control study 421:Systematic reviews 409:Guyatt and Sackett 254:Systematic reviews 187:levels of evidence 18:Levels of evidence 2933:Clinical research 2881: 2880: 2877: 2876: 2701:Spaced repetition 2661:Systematic review 1915:Clinical Medicine 1909:(December 2008). 1846:978-1-4443-4266-6 1713:(20): 1630–1632. 1606:(Suppl 3): 1–10. 1400:(10): 1278–1285. 1280:(22): 1800–1804. 1252:BMJ Best Practice 1018:(7102): 243–246. 406: 405: 242:clinical research 179: 178: 16:(Redirected from 2940: 2905: 2888: 2887: 2766: 2765: 2500: 2493: 2486: 2477: 2476: 2446: 2436: 2391: 2390: 2376: 2370: 2369: 2359: 2323: 2317: 2316: 2282: 2276: 2275: 2237: 2228: 2222: 2221: 2178: 2172: 2171: 2145: 2136: 2130: 2129: 2101: 2095: 2094: 2062: 2056: 2055: 2029: 2027:10.1.1.1016.5990 2014:Eval Health Prof 2009: 2003: 2002: 1959: 1953: 1952: 1942: 1903: 1897: 1896: 1863:(October 2011). 1857: 1851: 1850: 1830: 1824: 1823: 1813: 1780: 1774: 1773: 1745: 1739: 1738: 1701: 1695: 1694: 1684: 1647: 1641: 1638: 1632: 1631: 1594: 1588: 1587: 1579: 1573: 1570:Burns el al 2011 1567: 1561: 1560: 1558: 1556: 1541: 1535: 1534: 1532: 1530: 1525:on 31 March 2016 1514: 1508: 1506: 1486: 1480: 1479: 1469: 1445: 1439: 1438: 1426: 1420: 1419: 1409: 1385: 1379: 1378: 1368: 1359:(9): 1193–1254. 1344: 1335: 1329: 1323: 1316: 1310: 1304: 1298: 1297: 1268: 1262: 1261: 1259: 1258: 1248:"What is GRADE?" 1243: 1237: 1236: 1226: 1198: 1192: 1191: 1186:. 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2182:Upshur RE 2168:145592046 2154:: 11–20. 2052:206452088 2022:CiteSeerX 1907:Rawlins M 1893:170193949 1861:Solomon M 1168:16 August 987:109929514 927:1549-1676 843:0143-005X 710:In 2005, 681:Criticism 647:psoriasis 203:heuristic 118:Education 80:Dentistry 2928:Research 2918:Evidence 2846:Academic 2817:EUnetHTA 2443:21701348 2366:15717036 2340:Springer 2297:Springer 2272:38324417 2264:19395821 2218:36678226 2210:16227661 2126:55078796 2091:22035723 2044:22473325 1991:16227665 1949:19149278 1877:Springer 1820:15205295 1691:23245609 1628:36103291 1620:22512675 1555:25 March 1233:21208779 945:21559325 861:28847845 741:See also 716:doctrine 399:Very low 383:Moderate 300:Examples 252:(RCTs). 223:evidence 205:used to 201:), is a 138:Policing 100:Pharmacy 90:Medicine 67:Research 35:a series 33:Part of 2647:Methods 2434:3124652 2332:NeuroRx 1999:1156284 1963:Bluhm R 1940:4954394 1770:8691224 1735:8593521 1727:7474251 1682:4156511 1476:3355931 1467:1267740 1416:6722691 1407:1483525 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Index

Levels of evidence
a series
Evidence-based practices
Assessment
Design
Management
Research
Scheduling
Dentistry
Medical ethics
Medicine
Nursing
Pharmacy
Toxicology
Conservation
Education
Legislation
Library and information practice
Policy
Policing
Prosecution
v
t
e
heuristic
rank
experimental
medical research
epidemiological studies
evidence

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