Provide a general summary of the paper that is being critiqued, such as primary objective or hypothesis of the study, number of participants enrolled, and primary findings.

PAPER OUTLINE
Title:
Your title is not the same as the title of the paper being critiqued but may include the paper’s
title. Place quotation marks around article titles and underline the titles of the journal.
Ex.
A Critique of M Makrides’ “Effect of DHA Supplementation During Pregnancy on Maternal
Depression and Neurodevelopment of Young Children: a Randomized Controlled Trial”,
JAMA, 2010, Vol 304, No 15.
Author: Your Name
1. Introduction (1 – 2 pages)
a. Provide a clear introduction to the topic.
b. Specify which paper is being critiqued.
c. Provide a general summary of the paper that is being critiqued, such as primary
objective or hypothesis of the study, number of participants enrolled, and primary
findings.
2. Study design & Bias (1 – 2 pages)
a. Study design:
 Briefly describe the type of study design (RCT, case-control, cohort, or crosssectional).
 Evaluate the strengths and limitations of this study design for the stated objective
of the study. In other words, was this an appropriate type of study to answer the
research question?
b. Inclusion and exclusion criteria:
 Describe the study population and recruitment methods.
 How generalizable is this population? Does the study have selective sample?
c. Data collection methods for exposure and outcome.
 Describe the methods of data collection on the exposure and the outcome.
 Provide a critique of these methods—how valid do you consider the methods to be?
Are there any limitations of these methods (ex. Self-report data might be susceptible
to bias or error in recall)?
d. Risk of bias
 Please use Table 1 (for RCT) and Table 2 (for cross-sectional, case-control and
cohort studies) to discuss the potential bias.
 Describe how serious you think the bias is in the study (not serious, serious, or very
serious).
Table 1: Bias in randomized controlled trials

Bias	Explanation
Lack of allocation concealment	Those enrolling study participants are aware of the group to which the next enrolled participant will be allocated.
Lack of blinding	Research participants, investigators, caregivers, or data analysts are aware of the arm to which patients are allocated.

 

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Incomplete accounting of participants and outcome events	High losses to follow-up—more than 20% of the baseline sample is lost-to-follow-up Differential loss-to-follow-up—there are differences in loss-to follow-up between intervention and control groups.
Selective outcome reporting	Incomplete or absent reporting of some outcomes and not others.
Other limitations	Examples: Stopping trial early for no reason. Low adherence to the intervention. Poor quality data on adherence. Study population is not generalizable.

Table 2: Bias in observational studies

Bias	Explanation
Failure to develop and apply appropriate eligibility criteria	 Under- or over-matching in case-control studies  Selection of exposed and unexposed from different populations in cohort studies.
Flawed measurement of both exposure and outcome	 Differences in measurement of exposure (e.g. recall bias in case-control studies).  Differential surveillance for outcome in exposed and unexposed in cohort studies.
Failure to adequately control confounding	 Failure to accurately measure all known confounders.  Failure to match for potential confounders or make adjustment for confounding in statistical analysis.
Incomplete or inadequately short follow-up	High losses to follow-up—more than 20% of the baseline sample is lost-to-follow-up Differential loss-to-follow-up—there are differences in loss-to-follow-up between intervention and control groups.

3. Results (1-2 paragraphs)
a. Summarize the study findings and highlight the statistically significant results.
4. Criteria for deriving causal inference (1-2 pages)
Consider each of the criteria described in class and discuss how well the authors addressed
each one:
a. Consistency of results: Did the authors compare their study results with other existing
studies? If the study results are inconsistent with previous studies, did the author explain
why?
b. Strength of the association:
 How strong of an association is there between the exposure and the outcome.
Stronger associations provide stronger evidence of causality.
 Use Table 3 to determine if the magnitude of the effect is large or very large.
Table 3:Definitions of large and very large effect

Magnitude of Effect	Definition
Large	RR/OR >2 or <0.5
Very large	RR/OR >5 or <0.2

c. Biologic plausibility: Did the offers present any description of potential biologic
mechanisms that may explain the observed relationship?

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d. Dose-response gradient: Did the authors present any evidence that there may be a
dose-response relationship?
e. Temporality: Did the measurement of the exposure occur before the measurement of
the outcome?
f. Alternative explanations: How well did the authors address concerns about
confounding or bias in the study? Are there other factors that they did not address that
could explain the observed relationship?
5. Importance of the results (a paragraph)
 Is the outcome important? Are the authors solving an important question?
6. Conclusion (a paragraph)
 Summary of your paper critique. Overall, how would you rate the quality of the
evidence presented in this pap

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