| Study |
Bias |
| Randomisation process |
Deviations from intended interventions |
Missing outcome data |
Measurement of the outcome |
Selection of the reported results |
Overall |
| Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
| Berry 2021 |
Some concerns |
Method used to generate random sequence is adequate, however allocation is unclear as it appears to have been conducted by the psychologist who delivered the intervention.: "...the clinical psychologist who informed them of their treatment group assignment as dictated by a computer‐generated random assignment schedule".
No significant differences reported between groups: "Of the overall dataset (N = 109), those randomized to PREPP did not differ from those to ETAU on CM status, baseline demographic factors, or mood measures" |
Low risk of bias |
Participants and people delivering the interventions would have likely been aware of their group allocation due to differences in the interventions
No deviation from intended intervention specified, unlikely that the outcome would be impacted by lack of blinding
Modified ITT excluding participants with missing outcome data |
Low risk of bias |
Data available for all participants, although 55% dropout in total sample, only < 5% dropout based on unpublished subgroup data provided by authors |
Low risk of bias |
Validated outcome measure used
Same measurement and assessment time points used for all participants
Outcome assessors were blinded to treatment condition: "Maternal depressive symptoms were measured by a trained interviewer blind to the participants’ group assignment" |
Low risk of bias |
No published protocol, however outcomes in methods section align with those in the results
While two depression measures were used (one self‐report, one clinician rated) authors have provided clinician‐rated data, unlikely this was selected based on results but more likely as it is a less biased measure as assessors were blinded to group allocation
All reported results correspond to intended analyses |
Some concerns |
Overall some concerns due to no information about allocation concealment |
| Grote 2012 |
Some concerns |
Method used to generate random sequence is adequate: "Using a permuted block design stratified by race, we randomly assigned participants to receive either enhanced IPT‐B or UC"
Methods used to conceal allocation not described
No significant differences reported between groups: "Analyses show that participants in the IPT‐B and UC groups did not differ significantly on any of the baseline demographic or clinical characteristics" Note group size in total sample across IPT‐B and UC is equal, however group size is unequal when looking only at 'more exposure' (i.e., n = 6 in IPT‐B, n = 18 in UC). However, it would be more problematic if larger sample size was in IPT‐B group, as could indicate that preference was given to putting pts in the intervention group |
Low risk of bias |
Participants and people delivering the interventions would have likely been aware of their group allocation due to differences in the interventions
No deviation from intended intervention specified, unlikely that the outcome would be impacted by lack of blinding
Modified ITT excluding single participant with missing outcome data |
Low risk of bias |
Data available for almost all participants (data seems to be missing from one participant only) |
Some concerns |
Validated outcome measure used
Same measurement and assessment timepoints used for all participants
Measurement tool is self‐report so participants are assessors and cannot be blinded. Also states in limitation section: "raters may have been able to determine intervention due to differences in ease on contact to conduct follow up assessment"
The outcome assessment could be potentially influenced by the knowledge of the intervention received. It is unlikely that the reporting was influenced by the treatment received |
Low risk of bias |
No published protocol, however outcomes in methods section align with those in the results
All reported results correspond to intended outcome measurements
All reported results correspond to intended analyses |
Some concerns |
Overall some concerns due to no information about allocation concealment and potential bias in the measurement of outcome (self‐report) |
