| Quality Criteria Checklist: Primary Research Validity Questions |
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EVIDENCE WORKSHEET SCORE: _________ |
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| Journal Article Title ___________________________________________________ |
| Journal Article First Author _________________________________________________ |
| Publication Year: __________________________________________ |
| Journal Published: _______________________________________________________ |
| Name of Primary Reviewer: _________________________________________________ |
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| Directions for Reviewers. For each Journal Article included in the systematic reviews, use one checklist. There are 30 questions |
| related to the quality of the study. Check Yes, No, Unclear or (N/A) for each question. Then score yes responses as 1. |
| No and unclear responses are scored with 0. N/A is not scored. Sum the responses and divide by the total number of questions answered. |
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YES |
NO |
UNCLEAR |
N/A |
| 1. Research question |
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1.1 Was the research question clearly stated? |
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1.2 Was the authors' alternative hypothesis clear? |
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1.3 Was the target population and setting specified and appropriate? |
| 2. Selection of study subjects |
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2.1 Were the inclusion/exclusion criteria specified with sufficient detail? |
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2.3 Did the exclusion criteria NOT pertain to the main exposure or the main outcome? |
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2.4 Was the study sample representative of the target population? |
| 3. Response Rate |
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3.1 Were the response rates described? |
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3.2 Did response rates NOT differ by characteristics associated with the disease or exposure? |
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3.3 Did authors attempt to characterize the portion that did not participate? |
| 4. Was the method for handling withdrawals described? |
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4.1 Were follow-up methods described with sufficient detail? |
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4.2 Was lost to follow-up NOT differential between the diseased groups? |
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4.3 Were lost to follow-up NOT related to the main exposure? |
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YES |
NO |
UNCLEAR |
N/A |
| 5. Was blinding used to prevent the introduction of bias? |
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5.1 For intervention studies, were subjects and others blinded to treatment groups? |
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5.2 Were the methods for assigning subject to groups described as randomly assigned? |
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5.3 Was there NO evidence of non-compliance? |
| 6. Can causation be observed by the investigator? |
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6.1 Does the study design allow the investigator to infer causality? |
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6.2 Is the length of follow-up sufficient to produce an effect? |
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6.3 Did the exposure precede the disease? |
| 7. Exposure and outcomes |
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7.1 Were primary outcomes and exposures described and relevant to the question? |
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7.2 Were the exposure measurements based on valid data collection instruments? |
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7.5 Was there NO potential for misclassification of the exposure? |
| 8. Confounders |
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8.1 Were other factors (confounders) related to the disease and exposure identified? |
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8.2 Were appropriate methods used to control for confounders? |
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8.3 Did authors discuss residual confounding? |
| 9. Statistical analysis |
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9.1 Were statistical analyses adequately described? |
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9.2 Were measures of effects reported with levels of significance or confidence intervals? |
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9.3 Was clinical significance as well as statistical significance reported? |
| 10. Conclusions |
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10.1 Are the conclusions adequately supported by findings in tables and figures? |
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10.2 Are biases and limitations adequately discussed? |
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10.3 Were there no apparent conflicts of interest? |
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| RIGOR WORKSHEET SCORING EVALUATION |
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80-100% is a rigorous study |
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70-80% is a marginally rigorous study *as long as 6.1, 6.2 and 6.3 are yes. |
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70% or lower is not a rigorous study |
