From: Bone health in phenylketonuria: a systematic review and meta-analysis
Relevance questions | |
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1. | Would implementing the studied intervention procedures (if found successful) result in improved outcomes for the patients/clients/population group? (N/A for some Epidemiological studies) |
2. | Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? |
3. | Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dietetics practice? |
4. | Is the intervention or procedure feasible? (N/A for some Epidemiological studies) |
Validity questions | |
1. | Was the research question clearly stated? |
1.1 | Was the specific intervention(s) or procedure (independent variable(s)) identified? |
1.2 | Was the outcome(s) (dependent variable(s)) clearly indicated? |
1.3 | Were the target population and setting specified? |
2. | Was the selection of study subjects/patients free from bias? |
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? |
2.2 | Were criteria applied equally to all study groups and/or all subjects? |
2.3 | Were health, demographics, and other characteristics of subjects described? |
2.4 | Were the subjects/patients a representative sample of the relevant population? |
3 | Were study groups comparable? |
3.1 | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if Randomized Controlled Trial (RCT)) |
3.2 | Was the distribution of disease status, prognostic factors, and other factors (e.g. demographics) at baseline similar across study groups (original or created post hoc)? |
3.3 | Were concurrent controls used? (Concurrent preferred over historical controls.) |
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? (Criterion may not be applicable in some cross-sectional studies.) |
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.) |
3.6 | If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., “gold standard”)? |
4. | Was method of handling withdrawals described? |
4.1 | Were follow-up methods described and the same for all groups and/or all subjects? |
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%) |
4.3 | Were all enrolled subjects/patients (in the original sample) accounted for? |
4.4 | Were reasons for withdrawals similar across groups? |
4.5 | If diagnostic test, was decision to perform reference test not dependent on results of test under study? |
5. | Was blinding used to prevent introduction of bias? |
5.1 | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? |
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.) |
5.3 | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? |
5.4 | In case control study, was case definition explicit and case ascertainment not influenced by exposure status? |
5.5 | In diagnostic study, were test results blinded to patient history and other test results? |
6. | Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were intervening factors described? |
6.1 | In RCT or other intervention trial, were protocols described for all regiments studied? |
6.2 | In observational study, were interventions, study settings, and clinicians/provider described? |
6.3 | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? |
6.4 | Was the amount of exposure and, if relevant, subject/patient compliance measured? |
6.5 | Were co-interventions (e.g., ancillary treatments, other therapies) described? |
6.6 | Were extra or unplanned treatments described? |
6.7 | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? |
6.8 | In diagnostic study, were details of test administration and replication sufficient? |
7. | Were outcomes clearly defined and the measurements valid and reliable? |
7.1 | Were primary and secondary endpoints described and relevant to the question? |
7.2 | Were nutrition measures appropriate to question and outcomes of concern? |
7.3 | Was the period of follow-up long enough for important outcome(s) to occur? |
7.4 | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? |
7.5 | Was the measurement of effect at an appropriate level of precision? |
7.6 | Were other factors accounted for (measured) that could affect outcomes? |
7.7 | Were the measurements conducted consistently across groups? |
8.0 | Was the statistical analysis appropriate for the study design and type of outcome indicators? |
8.1 | Were statistical analyses adequately described the results reported appropriately? |
8.2 | Were correct statistical tests used and assumptions of test not violated? |
8.3 | Were statistics reported with levels of significance and/or confidence intervals? |
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)? |
8.5 | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? |
8.6 | Was clinical significance as well as statistical significance reported? |
8.7 | If negative findings, was a power calculation reported to address type 2 error? |
9. | Are conclusions supported by results with biases and limitations taken into consideration? |
9.1 | Is there a discussion of findings? |
9.2 | Are biases and study limitations identified and discussed? |
10. | Is bias due to study’s funding or sponsorship unlikely? |
10.1 | Were sources of funding and investigators’ affiliations described? |
10.2 | Was there no apparent conflict of interest? |