Cited by 435Meta-analysis and systematic reviewsClinical practice guidelines implementationHealth Sciences Research and Education

Extending an evidence hierarchy to include topics other than treatment: revising the Australian 'levels of evidence'

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Merlin, Tracy, Weston, Adele, Tooher, Rebecca·2009·BMC Medical Research Methodology

Abstract

BACKGROUND: In 1999 a four-level hierarchy of evidence was promoted by the National Health and Medical Research Council in Australia. The primary purpose of this hierarchy was to assist with clinical practice guideline development, although it was co-opted for use in systematic literature reviews and health technology assessments. In this hierarchy interventional study designs were ranked according to the likelihood that bias had been eliminated and thus it was not ideal to assess studies that addressed other types of clinical questions. This paper reports on the revision and extension of this evidence hierarchy to enable broader use within existing evidence assessment systems. METHODS: A working party identified and assessed empirical evidence, and used a commissioned review of existing evidence assessment schema, to support decision-making regarding revision of the hierarchy. The aim was to retain the existing evidence levels I-IV but increase their relevance for assessing the quality of individual diagnostic accuracy, prognostic, aetiologic and screening studies. Comprehensive public consultation was undertaken and the revised hierarchy was piloted by individual health technology assessment agencies and clinical practice guideline developers. After two and a half years, the hierarchy was again revised and commenced a further 18 month pilot period. RESULTS: A suitable framework was identified upon which to model the revision. Consistency was maintained in the hierarchy of "levels of evidence" across all types of clinical questions; empirical evidence was used to support the relationship between study design and ranking in the hierarchy wherever possible; and systematic reviews of lower level studies were themselves ascribed a ranking. The impact of ethics on the hierarchy of study designs was acknowledged in the framework, along with a consideration of how harms should be assessed. CONCLUSION: The revised evidence hierarchy is now widely used and provides a common standard against which to initially judge the likelihood of bias in individual studies evaluating interventional, diagnostic accuracy, prognostic, aetiologic or screening topics. Detailed quality appraisal of these individual studies, as well as grading of the body of evidence to answer each clinical, research or policy question, can then be undertaken as required.

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Research works printed but not linked: 2

  1. Merlin T Weston A Tooher R Revising a national standard: redevelopment of the Australian NHMRC evidence hierarchy Italian Journal of Public Health (Supplement 1) 2005 2 2 156
  2. Phillips B Ball C Sackett D Badenoch D Straus S Haynes B Dawes M Oxford Centre for Evidence-Based Medicine Levels of Evidence (May 2001) 2001 Oxford: Centre for Evidence-Based Medicine

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Authors
Merlin, T., Weston, A., & Tooher, R.
Affiliations
The University of Adelaide (AU)
Corresponding author
Merlin, Tracy
Venue
BMC Medical Research Methodology
Published
2009-06-11
Volume
9
Issue
1
Pages
34-34
ISSN
1471-2288 (ISSN-L)
OpenAlex
W2044921283
Cited by
435
References
41
Citations by year
2026: 9 · 2025: 23 · 2024: 16 · 2023: 39 · 2022: 41 · 2021: 41 · 2020: 33 · 2019: 35 · 2018: 37 · 2017: 27 · 2016: 24 · 2015: 17 · 2014: 22 · 2013: 28 · 2012: 10
FWCI
17.82
Type
journal article
Language
en
Open access
Locations
  • BMC Medical Research Methodology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
National Health and Medical Research Council
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
  • Health Sciences › Health Professions › General Health Professions › Health Sciences Research and Education
Keywords
level of evidence, evidence hierarchy, bias assessment, diagnostic accuracy studies, prognostic studies, screening studies, health technology assessment, systematic reviews, evidence appraisal, research ethics
MeSH terms
Clinical Trials as Topic, Decision Support Techniques, Humans, Evidence-Based Medicine

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