Critical Appraisal Checklist: Diagnostic Test Study

For clinicians to use a diagnostic test in clinical practice, they need to know how well the test distinguishes between those who have the suspected disease or
condition and those who do not. Diagnostic test studies evaluate a test for diagnosing a disease.

What did they do? (Methods) What was the answer? (Results) What did they say about the What do I do with this
answer? (Conclusion) information?

1. Was there an independent,
blind comparison with
reference to a “gold”
standard?
2. Was the test evaluated in an
appropriate spectrum of
patients (like those in whom
we would use it in practice)?
3. Was the reference standard
ascertained regardless of the
diagnostic test result?
1. What likelihood ratios are
associated with the range of
possible test results?
1. Do the results of the study
support the author/s
conclusions?
2. Does the conclusion reflect
the discussion?
3. Are there study limitations,
and do these impact the
conclusions?
4. Are potential discrepancies
Mentioned?
1. Will the reproducibility of the
test result and its
interpretation be satisfactory
in my setting?
2. Are the results applicable to
my patient?
3. Will the results change my
management?
4. Will patients be better off as
a result of the test?

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 Critical Appraisal Checklist: Differential Diagnosis
Differential Diagnosis involves the process of weighing the probability that one disease rather than another disease accounts for a patient’s illness. The Differential
Diagnosis Study tries to sort out what proportion of the patients with a single sign or symptom has various diseases.

What did they do? (Methods) What was the answer? (Results) What did they say about the What do I do with this
answer? (Conclusion) information?

1. Did the investigators enroll
the right patients?
2. Was the patient sample
representative of those with
the clinical problem?
3. Was the definitive diagnostic
standard appropriate?
4. Was the diagnostic process
credible?
5. For initially undiagnosed
patients, was follow-up
sufficiently long and
complete?
1. What were the diagnoses and
their probabilities?
2. How precise are these
estimates of disease
probability?
1. Do the results of the study
support the author/s
conclusions?
2. Does the conclusion reflect
the discussion?
3. Are there study limitations,
and do these impact the
conclusions?
4. Are potential discrepancies
mentioned?
1. Are the study patients similar
to my own?
2. Is it unlikely that the disease
possibilities or probabilities
have changed since this
evidence was gathered?

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An economic analysis can provide accurate values to assess the cost of disease and the cost-benefit of interventions.
What did they do? (Methods)
1. Did the analysis provide a full
economic comparison of
health care strategies?
2. Were the costs and outcomes
properly measured and
valued?
3. Was appropriate allowance
made for uncertainties in the
analysis?
4. Are estimates of costs and
outcomes related to the
baseline risk in the treatment
population?
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Critical Appraisal Checklist: Economic Analysis
What was the answer? (Results)
1. What were the incremental
costs and outcomes of each
strategy?
2. Do incremental costs and
outcomes differ between
subgroups?
3. How much does allowance for
uncertainty change the
results?
What did they say about the What do I do with this
answer? (Conclusion) information?
1. Do the results of the study 1. Are the treatment benefits
support the author/s worth the harms and costs?
conclusions? 2. Could my patients expect
2. Does the conclusion reflect similar health outcomes?
the discussion? 3. Could I expect similar costs?
3. Are there study limitations,
and do these impact the
conclusions?
4. Are potential discrepancies
mentioned?
 Critical Appraisal Checklist: Harm / Etiology
A Harm/Etiology study addresses how to identify causes for disease (including iatrogenic forms – ie caused by the healthcare system)

What did they do? (Methods) What was the answer? (Results) What did they say about the What do I do with this
answer? (Conclusion) information?

1. Were there clearly defined 1. How strong is the association 1. Do the results of the study 1. Were the study patients
groups of patients, similar in between exposure and support the author/s similar to the patient in my
all important ways other than outcome? conclusions? practice?
exposure to the treatment or 2. How precise is the estimate of 2. Does the conclusion reflect 2. Was the duration of follow-up
other cause? risk? the discussion? adequate?
2. Were the 3. Are there study limitations, 3. What was the magnitude of
treatments/exposures and and do these impact the the risk?
clinical outcomes measured in conclusions? 4. Should I attempt to stop the
the same ways in both 4. Are potential discrepancies exposure?
groups? (Was the assessment mentioned?
of outcomes either objective
or blinded to exposure?
3. Was the follow-up of the
study patients sufficiently long
(for the outcome to occur)
and complete?
4. Do the results of the harm
study fulfill some of the
diagnostic tests for causation?
5. Were the outcomes and
exposures measured in the
same way in the groups being
compared?

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A prognostic study addresses how to estimate the patient’s likely clinical course over time and anticipate likely complications of disease.
What did they do? (Methods)
1. Was the sample of patients
representative?
2. Were the patients significantly
homogeneous with respect to
prognostic risk?
3. Was follow-up complete?
4. Were objective and unbiased
outcome criteria used?
5. If subgroups with different
prognoses are identified:
was there adjustment for
important prognostic factors?
was there vadidation in an
independent group of "test-
set" patients?
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Critical Appraisal Checklist: Prognostic
What was the answer? (Results)
1. How likely are the outcomes
over time?
2. How precise are the estimates
of likelihood?
What did they say about the
answer? (Conclusion)
1. Do the results of the study
support the author/s
conclusions?
2. Does the conclusion reflect
the discussion?
3. Are there study limitations,
and do these impact the
conclusions?
4. Are potential discrepancies
mentioned?
What do I do with this
information?
1. Were the study patients and
their management similar to
those in my practice?
2. Was the follow-up sufficiently
long?
3. Can I use the results in the
management of patients in
my practice?

A practice guideline study is a systematically developed statement on medical practice that assists a practitioner and a patient in making decisions about appropriate
health care for specific medical conditions.
What did they do? (Methods)
1. Did the recommendations
consider all relevant patient
groups, management options,
and possible outcomes?
2. Is there a systematic review of
evidence linking options to
outcomes for each relevant
question?
3. Is each of its recommendations
both tagged by the level of
evidence upon which it is based
and linked to a specific citation?
4. Do the authors indicate the
strength of their
recommendations?
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Critical Appraisal Checklist: Practice Guideline
What was the answer? (Results)
1. What are the key
recommendations?
What did they say about the What do I do with this
answer? (Conclusion) information?
1. Do the results of the study 1. Do the recommendations
support the author/s make sense in my practice
setting?
conclusions?
2. Does the conclusion reflect
the discussion?
3. Are there study limitations,
and do these impact the
conclusions?
4. Are potential discrepancies
mentioned?

A qualitative study deals with phenomena that are difficult or impossible to quantify mathematically, such as beliefs, meanings, attributes, and symbols.
What did they do? (Methods)
1. Was the choice of participants
explicit and comprehensive?
2. Was data collection
sufficiently comprehensive
and detailed?
3. Were the data analyzed
appropriately and the findings
corroborated adequately?
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Critical Appraisal Checklist: Qualitative
What was the answer? (Results)
1. What are the results of the
study?
What did they say about the
answer? (Conclusion)
1. Does the study offer helpful
theoretical conclusions?
2. Does the conclusion reflect
the discussion?
3. Are there study limitations,
and do these impact the
conclusions?
4. Are potential discrepancies
mentioned?
What do I do with this
information?
1. Does the study help me
understand the context of my
practice?
2. Does the study help me to
understand my relationships
with patients and their
families?
 Critical Appraisal Checklist: Systematic Review
A systematic review is a literature review focused on a single question that tries to identify, appraise, select and synthesize all high quality research evidence relevant
to that question. A meta-analysis is a survey in which the results of all of the included studies are similar enough statistically that the results are combined and
analyzed as if they were one study.

What did they do? (Methods) What was the answer? (Results) What did they say about the What do I do with this
answer? (Conclusion) information?

1. Did the review explicitly
address a sensible question?
2. Was the search for relevant
studies detailed and
exhaustive?
3. Were the primary studies of
high methodologic quality?
4. Were the assessments of
included studies
reproducible?
1. What are the overall results of
the review?
2. Were the results similar from
study to study?
1. Do the results of the study
support the author/s
conclusions?
2. Does the conclusion reflect
the discussion?
3. Are there study limitations,
and do these impact the
conclusions?
4. Are potential discrepancies
mentioned?
1. How can I best interpret the
results to apply them to the
care of patients in my
practice?
2. Were all patient important
outcomes considered?
3. Are the benefits worth the
potential costs and risks?

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 Critical Appraisal Checklist: Therapy
A therapy study addresses how to select treatments to offer patients that do more good than harm and that are worth the efforts and costs of using them.

What did they do? (Methods) What was the answer? (Results) What did they say about the What do I do with this
answer? (Conclusion) information?

1. Were patients randomized? 1. How large was the treatment 1. Do the results of the study 1. Were the study patients
2. Was randomization effect? support the author/s similar to my patients?
concealed? 2. How precise was the estimate conclusions? 2. Were all patient important
3. Were patients analyzed in the of the treatment effect? outcomes considered?
2. Does the conclusion reflect
groups to which they were 3. Are the likely benefits worth
randomized? the discussion? the potential harms and
4. Were patients in the 3. Are there study limitations, costs?
treatment and control groups and do these impact the
similar with respect to known conclusions?
prognostic factors? 4. Are potential discrepancies
5. Were 5 important groups mentioned?
(patients, caregivers,
collectors of outcome data,
adjudicators of outcome, data
analysts) aware of group
allocation?
6. Aside from the experimental
intervention, were the groups
treated equally?
7. Was follow-up complete?

Adapted from: Duke University Medical Center & Archives, Evidence Based Practice
http://guides.mclibrary.duke.edu/content.php?pid=274373&sid=2262324