Quality Component | Assessment Criteria |
---|---|
Selection Bias | Degree to which participants are representative of target population Percentage of study candidates who agreed to participate |
Design | Study design Description of randomization process Appropriate randomization sequence |
Confounders | Controlling of confounders via design Baseline balance as to confounders |
Blinding | Outcome assessors Participants |
Data Collection | Reliability and validity of assessment tools/methods |
Withdrawals and Drop-Outs | Reporting of withdrawal numbers and reasons Percentage of participants completing the study |
Intervention Integrity | Percentage of participants receiving intended intervention Measurement of consistency of intervention administration Contamination/unintended intervention |
Analysis Appropriate to Question | Level of allocation and analyses Appropriateness of statistical methods to study design Analyses for intention-to-treat |
Global Quality Rating | Strong = 4 strong ratings and 0 weak ratings Moderate = less than 4 strong ratings and 1 weak rating Weak = 2+ weak ratings |