Table 1.
Quality assessment domains-Prospective trials RCT/non RCT | ||
Participation bias | Yes | No |
Population of interest is adequately described for key characteristics | ||
Study setting and geographic location is adequately described | ||
Baseline sample is adequately described for key characteristics | ||
Inclusion and exclusion criteria are adequately described | ||
Patients were balanced in all aspects except the intervention | ||
Attrition bias | Yes | No |
Follow-up is sufficiently long for outcome to occur (≥6 months) | ||
Proportion of sample completing the study is adequate (≥80%) | ||
Description of withdrawal (incomplete outcome data) is provided | ||
Characteristics of drop-outs versus completers is provided | ||
Outcome measurement | ||
Definition of outcome is provided a priori | ||
Objective definition of outcome is provided | ||
Data analysis and reporting | Yes | No |
Alpha error and/or beta error is specified a priori | ||
Data analysis was based on intention-to-treat analysis principle | ||
Frequencies of most important data (for example, outcomes) are presented | ||
Quality assessment domains – Retrospective studies | ||
Data | Yes | No |
Were treatment and/or important details of treatment exposure adequately recorded for the study purpose in the data source? | ||
Were the primary outcomes adequately recorded for the study purpose (e.g., available in sufficient detail through data source | ||
Was the primary clinical outcome(s) measured objectively rather than subject to clinical judgment (e.g., opinion about whether the patient's condition has improved | ||
Were primary outcomes validated, adjudicated, or otherwise known to be valid in a similar population? | ||
Was the primary outcome(s) measured or identified in an equivalent manner between the treatment/intervention group and the comparison group(s)? | ||
Were important covariates that may be known confounders or effect modifiers available and recorded? | ||
Methods | Yes | No |
Was the study (or analysis) population restricted to new initiators of treatment or those starting a new course of treatment? | ||
If one or more comparison groups were used, were they concurrent comparators? If not, did the authors justify the use of historical comparisons group(s)? | ||
Were important covariates, confounding and effect modifying variables taken into account in the design and/or analysis? | ||
Is the classification of exposed and unexposed person-time free of “immortal time bias”? | ||
Were any meaningful analyses conducted to test key assumptions on which primary results are based? |
RCT, randomized controlled trial.