Quality Criteria Checklist: Primary Research
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Relevance Questions
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1. |
Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) |
Yes
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2. |
Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? |
Yes
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3. |
Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? |
Yes
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4. |
Is the intervention or procedure feasible? (NA for some epidemiological studies) |
Yes
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Validity Questions
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1. |
Was the research question clearly stated? |
Yes
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1.1. |
Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? |
Yes
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1.2. |
Was (were) the outcome(s) [dependent variable(s)] clearly indicated? |
Yes
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1.3. |
Were the target population and setting specified? |
Yes
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2. |
Was the selection of study subjects/patients free from bias? |
Yes
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2.1. |
Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? |
Yes
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2.2. |
Were criteria applied equally to all study groups? |
Yes
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2.3. |
Were health, demographics, and other characteristics of subjects described? |
Yes
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2.4. |
Were the subjects/patients a representative sample of the relevant population? |
No
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3. |
Were study groups comparable? |
Yes
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3.1. |
Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) |
Yes
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3.2. |
Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? |
Yes
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3.3. |
Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) |
Yes
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3.4. |
If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? |
N/A
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3.5. |
If case control study, were potential confounding factors comparable for cases and controls?
(If case series or trial with subjects serving as own control, this criterion is not applicable.) |
N/A
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3.6. |
If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? |
Yes
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4. |
Was method of handling withdrawals described? |
Yes
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4.1. |
Were follow-up methods described and the same for all groups? |
Yes
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4.2. |
Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) |
Yes
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4.3. |
Were all enrolled subjects/patients (in the original sample) accounted for? |
Yes
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4.4. |
Were reasons for withdrawals similar across groups? |
Yes
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4.5. |
If diagnostic test, was decision to perform reference test not dependent on results of test under study? |
Yes
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5. |
Was blinding used to prevent introduction of bias? |
Yes
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5.1. |
In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? |
Yes
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5.2. |
Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) |
Yes
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5.3. |
In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? |
N/A
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5.4. |
In case control study, was case definition explicit and case ascertainment not influenced by exposure status? |
N/A
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5.5. |
In diagnostic study, were test results blinded to patient history and other test results? |
Yes
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6. |
Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? |
Yes
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6.1. |
In RCT or other intervention trial, were protocols described for all regimens studied? |
Yes
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6.2. |
In observational study, were interventions, study settings, and clinicians/provider described? |
N/A
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6.3. |
Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? |
Yes
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6.4. |
Was the amount of exposure and, if relevant, subject/patient compliance measured? |
Yes
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6.5. |
Were co-interventions (e.g., ancillary treatments, other therapies) described? |
Yes
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6.6. |
Were extra or unplanned treatments described? |
Yes
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6.7. |
Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? |
Yes
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6.8. |
In diagnostic study, were details of test administration and replication sufficient? |
Yes
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7. |
Were outcomes clearly defined and the measurements valid and reliable? |
Yes
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7.1. |
Were primary and secondary endpoints described and relevant to the question? |
Yes
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7.2. |
Were nutrition measures appropriate to question and outcomes of concern? |
Yes
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7.3. |
Was the period of follow-up long enough for important outcome(s) to occur? |
Yes
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7.4. |
Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? |
Yes
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7.5. |
Was the measurement of effect at an appropriate level of precision? |
Yes
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7.6. |
Were other factors accounted for (measured) that could affect outcomes? |
Yes
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7.7. |
Were the measurements conducted consistently across groups? |
Yes
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8. |
Was the statistical analysis appropriate for the study design and type of outcome indicators? |
Yes
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8.1. |
Were statistical analyses adequately described and the results reported appropriately? |
Yes
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8.2. |
Were correct statistical tests used and assumptions of test not violated? |
Yes
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8.3. |
Were statistics reported with levels of significance and/or confidence intervals? |
Yes
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8.4. |
Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? |
Yes
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8.5. |
Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? |
Yes
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8.6. |
Was clinical significance as well as statistical significance reported? |
Yes
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8.7. |
If negative findings, was a power calculation reported to address type 2 error? |
Yes
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9. |
Are conclusions supported by results with biases and limitations taken into consideration? |
Yes
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9.1. |
Is there a discussion of findings? |
Yes
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9.2. |
Are biases and study limitations identified and discussed? |
Yes
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10. |
Is bias due to study's funding or sponsorship unlikely? |
Yes
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10.1. |
Were sources of funding and investigators' affiliations described? |
Yes
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10.2. |
Was the study free from apparent conflict of interest? |
Yes
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