Component | Becker et al. [30] | Rubak et al. [31] |
---|---|---|
Selection Bias 1. Are the individuals selected to participate likely to be representative of the target populations? | Can’t tell = 4 | Can’t tell = 4 |
Selection Bias 2. What percentage of the selected individuals agreed to participate? | Less than 60% agreement = 3 | Can’t tell = 5 |
SELECTION BIAS RATING | WEAK | WEAK |
Study design | Randomized control trial = 1 | Randomized control trial = 1 |
Was the study described as randomized? | Yes | Yes |
Was the method of randomization described? | Yes | Yes |
Was the randomization process appropriate? | Yes | Yes |
Study design rating | Strong | Strong |
Were there important differences between groups prior to the intervention? | No = 2 | No = 2 |
What percentage of relevant confounders were controlled? | N/A | N/A |
Confounders rating | Strong | Strong |
Were the outcome assessors aware of the intervention status of participants? | Can’t tell = 3 | Can’t tell = 3 |
Were the participants aware of the research question? | No = 2 | No = 2 |
Blinding rating | Moderate | Moderate |
Were data collection tools shown to be valid? | Yes = 1 | Yes = 1 |
Were data collections tools shown to be reliable? | Yes = 1 | Yes = 1 |
Data collection rating | Strong | Strong |
Were withdrawals and drop-outs reported in terms of numbers/reasons? | Yes = 1 | Yes = 1 |
Percentage of participants completing the study | 80 = − 100% = 1 | 80 = −100% = 1 |
Withdrawals and drop outs rating | Strong | Strong |
Intervention Integrity: What percentage of participants received the allocated intervention? | 80 = −100% = 1 | 80 = − 100% = 1 |
Was the consistency of the intervention measured | Can’t tell = 3 | Can’t tell = 3 |
Is it likely that subjects received an unintended intervention that may influence results? | No = 5 | No = 5 |
Analyses: Unit of allocation | Practice | Practice |
Unit of analysis | Individual | Individual |
Are the statistical methods appropriate for the study design? | Yes = 1 | Yes = 1 |
Is the analysis performed by intervention allocation status (ITT) rather than actual intervention received? | Yes = 1 | Yes = 1 |