Tools for Grading Evidence: strengths

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Tools for Grading Evidence: strengths,
weaknesses, and the impact on
effective knowledge translation
Relevant conference theme: Concepts and methods
Translating Research Into Practice – Dementia and
Public Health (TRIP-DPH)
Michelle Irving, Nic Cherbuin, Ranmalee Eramudugolla, Peter Butterworth, Lily O'Donoughue Jenkins,
Kaarin Anstey
Rating evidence and knowledge translation:
Could grading tools be selling us short?
• Knowledge Translation is defined by the World Health Organization
as “the synthesis, exchange, and application of knowledge by
relevant stakeholders to accelerate the benefits of global and local
innovation in strengthening health systems and improving people’s
health” (WHO, 2005).
• This objective is compromised when a body of research is
oversimplified, graded incorrectly, or not fully understood by those
relying on flawed grading systems to inform their decision making.
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Translating Research into Practice –
Dementia and Public Health (TRIP-DPH)
TRIP-DPH is an ARC Linkage collaboration between the Australian National University, ACT
Health and Alzheimer‟s Australia. The project is examining multiple barriers to effective
knowledge translation and what can be done to make improvements.
One of the barriers identified pertains to the vast quantities of research that decision makers
are confronted with and the issues that arise from trying to evaluate the quality of such
evidence. How do those working outside the research world distinguish strong evidence from
weak evidence?
This well known problem has broadly been addressed through the development of hundreds
of grading instruments for evaluating individual studies and systematic reviews
If these tools are flawed, over-reliance on them may lead to miscommunication and incorrect
assessments of the evidence base, compromising knowledge translation
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What is grading?
• Grading instruments provide a metric to „quantify‟ the quality of
evidence from either an individual study or from a body of evidence
• Typically, they comprise a list of criteria and instructions for
application of these criteria in order to achieve a quality rating or
„grade‟
• Ratings for scales and checklists are frequently presented as a
whole score or fraction (e.g. 18/20) while ratings that are applied to
bodies of evidence are usually grade A, B, C etc.
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Examples of grading instruments
Grading a body of evidence
Grading individual studies
Grading of Recommendations Assessment,
Development and Evaluation (GRADE)
Critical Appraisal Skills Program (CASP)
National Health and Medical Research
Council - FORM (NHMRC-FORM)
Graphic Appraisal Tool for Epidemiology
(GATE)
Scottish Intercollegiate Guidelines Network
(SIGN)
Downs and Black Checklist
National Service Framework for Long Term
Conditions (NSF-LTC)
Newcastle-Ottawa Scale (NOS)
Strength of Recommendations Taxonomy
(SORT)
Risk of Bias Assessment Tool for
Nonrandomized Studies (RoBANS)
National Institute for Clinical Evidence
(NICE) Guidelines
Jadad Scale (aka Oxford Quality Scoring
System)
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What types of criteria are included?
While these tools vary, typically the criteria used to rate evidence
includes some or all of the below:
Precision
Quantity
Coherence
Directness
Consistency
Strength of
Evidence
Doseresponse
relationship
Publication
Bias
Magnitude
of Effect
Bias
Hierarchy
of study
design
Plausible
Confounding
Evidence can be rated
up or down depending
on how well it meets
criteria in any one of
these domains.
Different grading
systems place less or
more emphasis on
different components.
Coleman, C. I., R. Talati, et al. (2009). A Clinician's Perspective on Rating the
Strength of Evidence in a Systematic Review. Pharmacotherapy, 29(9), 1017-1029.
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Why is grading evidence a good idea?
Objective
Systematic approach
Time effective
Can minimise bias in
assessments
Instruments often facilitate
quick assessments
Not reliant on author(s)‟s view
of the strength of their
research
Accessible
Clear
High Impact
Once studies have been
graded the results are usually
broadly available for others to
see and use
Grades are a straightforward
way to communicate to those
who are not necessarily
equipped to evaluate research
Grades of systematic reviews
are often used to address real
world problems (e.g. clinical
guidelines)
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What are the problems?
Lack of validation and
poor reliability
Highly subjective - low
interrater reliability
Create false sense of
trust or over-reliance on
grading outcomes
Overly complicated,
unclear instructions and
little or no training –
mistakes made
Biased in favour of
certain types of studies
(e.g. randomised control
trials) and against others
(e.g. observational)
Grading of evidence may
not be applicable to local
settings
(Bagshaw & Bellomo, 2008; Baker et al., 2011; Baker et al., 2010; Barbui et al., 2010; Brouwers et al., 2005; Calderón et al., 2006; Colle et al., 2002; Gugiu &
Gugiu, 2010; Hartline et al. 2012; Ibargoyen-Roteta et al., 2010; Juni et al., 1999; Katrak et al., 2004; Kavanagh, 2009; Persaud & Mamdani, 2006)
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Why should policy makers, practitioners and
other decision makers care?
• Even if you don‟t directly use one of these instruments, chances are
that you have relied on research that is evaluated by them:
e.g. NHMRC guidelines, Cochrane Collaboration reviews, WHO
recommendations, NIH reports
• This research may have been graded in ways that do not accurately
represent the strength of the evidence, leading to flawed
conclusions
• Decisions made on the basis of erroneous evidence could lead to
resources being misdirected to less worthy causes or away from
more worthy causes
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Example: Smoking as a risk factor for
Alzheimer‟s Disease
• In 2010 the US Department of Health and Human Services National
Institutes of Health (NIH) released a report, “Preventing Alzheimer‟s
Disease and Cognitive Decline” (Williams et al., 2010). It aimed to,
„help clinicians, employers, policymakers, and others make informed
decisions about the provision of health care services.‟
• In this report a systematic review by Anstey et al. (2007) on the
effects of smoking on Alzheimer‟s Disease was given a „low‟ quality
rating, as assessed using the GRADE approach. There are at least
two major problems with this rating:
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Example: Smoking as a risk factor for
Alzheimer‟s Disease
1. The systematic review was downgraded because it relied on
observational studies rather than using randomised control trials.
However in research on smoking it is not ethical to perform
randomised control trials, as such observational studies were the
strongest possible form of evidence available.
2. Grading failed to take into account additional sources of evidence
that fall outside the scope of GRADE‟s rating criteria. This includes
a convergence of evidence from other research areas, such as
animal studies that have also linked smoking and cognitive decline.
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Potential outcome of flawed grading
If the strongest possible evidence is graded as „low‟ due to
ineffective use of grading systems it is possible that health
practitioners and policy makers may conclude that there
are no grounds to recommend reduction or cessation of
smoking as a preventative means of decreasing dementia.
Smokers themselves may also directly interpret such
information as reassurance that their use of tobacco is not
linked with increased risk. Such an outcome has the
potential to maintain the prevalence of this costly disease
at higher levels.
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Where to from here?
1. At a minimum researchers, policy makers and practitioners should
be aware of the shortcomings of grading instruments. Critical
evaluation of their conclusions is necessary before relying on
grades as a form of evidence for decision making
2. There should be greater emphasis on applying the correct grading
system to the type of evidence
3. Options include creating a new instrument, having multiple
instruments that are more targeted for specific types of research, or
modifying existing instruments to address criticisms
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References
Anstey, K. J., von Sanden, C., Salim, A., & O'Kearney, R. (2007). Smoking as a risk factor for dementia and cognitive decline: a meta-analysis of prospective studies. American
Journal of Epidemiology, 166(4), 367-78
Bagshaw, S. M. and R. Bellomo (2008). The need to reform our assessment of evidence from clinical trials: A commentary. Philosophy, Ethics, and Humanities in Medicine, 3(1), 23
Baker, A., J. Potter, et al. (2011). The applicability of grading systems for guidelines. Journal of Evaluation in Clinical Practice, 17(4), 758-762
Baker, A., K. Young, et al. (2010). A review of grading systems for evidence-based guidelines produced by medical specialties. Clinical medicine, 10(4), 358-363
Barbui, C., T. Dua, et al. (2010). Challenges in Developing Evidence-Based Recommendations Using the GRADE Approach: The Case of Mental, Neurological, and Substance Use
Disorders. PLOS Medicine, 7(8)
Brouwers, M. C., M. E. Johnston, et al. (2005). Evaluating the role of quality assessment of primary studies in systematic reviews of cancer practice guidelines." BMC Medical
Research Methodology, 5(1), 8
Calderón, C., R. Rotaeche, et al. (2006). Gaining insight into the Clinical Practice Guideline development processes: qualitative study in a workshop to implement the GRADE
proposal in Spain. BMC Health Services Research, 6(1), 138
Coleman, C. I., R. Talati, et al. (2009). A Clinician's Perspective on Rating the Strength of Evidence in a Systematic Review. Pharmacotherapy, 29(9), 1017-1029
Colle, F., F. Rannou, et al. (2002). Impact of quality scales on levels of evidence inferred from a systematic review of exercise therapy and low back pain. Archives of Physical
Medicine and Rehabilitation, 83(12), 1745-1752
Gugiu, P. C. & M. R. Gugiu (2010). A Critical Appraisal of Standard Guidelines for Grading Levels of Evidence. Evaluation & the Health Professions, 33(3), 233-255
Hartling, L., R. M. Fernandes, et al. (2012). From the trenches: a cross-sectional study applying the GRADE tool in systematic reviews of healthcare interventions. PloS One, 7(4),
e34697
Ibargoyen-Roteta, N., I. Gutiérrez-Ibarluzea, et al. (2010). The GRADE approach for assessing new technologies as applied to apheresis devices in ulcerative colitis. Implementation
Science, 5(1), 48
Jüni, P., A. Witschi, et al. (1999). The Hazards of Scoring the Quality of Clinical Trials for Meta-analysis. Journal of the American Medical Association, 282(11), 1054-1060
Katrak, P., A. Bialocerkowski, et al. (2004). A systematic review of the content of critical appraisal tools. BMC Medical Research Methodology, 4(1), 22
Kavanagh, B. P. (2009). The GRADE system for rating clinical guidelines. PLoS Medicine, 6(9), e1000094
Persaud, N. & M. M. Mamdani (2006). External validity: the neglected dimension in evidence ranking. Journal of Evaluation in Clinical Practice, 12(4), 450-453
Williams, J.W., Plassman, B.L., Burke, J., Holsinger, T., Benjamin, S. (2010). Preventing Alzheimer‟s Disease and Cognitive Decline. Evidence Report/Technology Assessment No.
193. AHRQ Publication No. 10-E005. Rockville, MD: Agency for Healthcare Research and Quality.
World Health Organization (2005). Bridging the “Know–Do” gap: Meeting on knowledge translation in global health. Retrieved from
http://www.who.int/kms/WHO_EIP_KMS_2006_2.pdf
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Grading Instrument References
CASP: Details available at the Critical Appraisal Skills Program website: http://www.casp-uk.net/
Downs & Black Checklist: Downs, S. H., & Black, N. (1998). The feasibility of creating a checklist for the assessment of the methodological quality both of
randomised and non-randomised studies of health care interventions. Journal of Epidemiology and Community Health, 52(6), 377-384.
GATE: Jackson, R., Ameratunga, S., Broad, J., Connor, J., Lethaby, A., Robb, G., ... & Heneghan, C. (2006). The GATE frame: critical appraisal with pictures.
Evidence Based Medicine, 11(2), 35-38
GRADE: Details available at the Grading of Recommendations, Assessment, Development and Evaluations Working Group website:
http://www.gradeworkinggroup.org/
JADAD: Jadad, A. R., Moore, R. A., Carroll, D., Jenkinson, C., Reynolds, D. J. M., Gavaghan, D. J., & McQuay, H. J. (1996). Assessing the quality of reports
of randomized clinical trials: is blinding necessary?. Controlled clinical trials, 17(1), 1-12.
NHMRC-FORM: Hillier, S., Grimmer-Somers, K., Merlin, T., Middleton, P., Salisbury, J., Tooher, R., & Weston, A. (2011). FORM: An Australian method for
formulating and grading recommendations in evidence-based clinical guidelines. BMC medical research methodology, 11(1), 23
NICE: Details available at National Institute for Health and Clinical Effectiveness website:
http://www.nice.org.uk:80/aboutnice/howwework/developingniceclinicalguidelines/clinicalguidelinedevelopmentmethods/clinical_guideline_development_metho
ds.jsp
NOS: Wells, G. A., Shea, B., O‟connell, D., Peterson, J., Welch, V., Losos, M., & Tugwell, P. (2000). The Newcastle-Ottawa Scale (NOS) for assessing the
quality of nonrandomised studies in meta-analyses. Details available at: http://www.medicine.mcgill.ca/rtamblyn/Readings/The%20Newcastle%20%20Scale%20for%20assessing%20the%20quality%20of%20nonrandomised%20studies%20in%20meta-analyses.pdf
NSF-LTC: Turner-Stokes, L., Harding, R., Sergeant, J., Lupton, C., & McPherson, K. (2006). Generating the evidence base for the National Service Framework
for Long Term Conditions: a new research typology. Clinical medicine, 6(1), 91-97.
RoBANS: Park, J., Lee, Y., Seo, H., Jang, B., Son, H., & Kim, S. Y. (2011). Risk of bias assessment tool for non-randomized studies (RoBANS): development
and validation of a new instrument. In Proceedings of the 19th Cochrane Colloquium (pp. 19-22).
SIGN: Scottish Intercollegiate Guidelines Network methodology available at: http://www.sign.ac.uk/guidelines/fulltext/50/index.html
SORT: Ebell, M.H., Siwek, J., Weiss, B.D., Woolf, S.H., et al. (2004). Strength of Recommendation Taxonomy (SORT): a patient-centered approach to grading
evidence in the medical literature. American Family Physician, 69, 549-57.
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Contact author
Michelle Irving
Centre for Research on Ageing, Health and Wellbeing
Australian National University
michelle.irving@anu.edu.au
www.crahw.anu.edu.au
The First Global Conference on Research Integration and Implementation,
http://www.I2Sconference.org/
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