| 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) |
| Upshur 2016 |
Some concerns |
Method used to generate random sequence is not fully adequate (i.e., unclear how the statistician selected the intervention site), while method used to conceal allocation is adequate: "One center was chosen randomly to implement the intervention integrated with usual prenatal care, the other site continued usual prenatal care only, which included prenatal advocate visits and services, routine prenatal care visits, and referral to on‐site mental health services if a woman screened positive for depression or PTSD...by a statistician unfamiliar with the project"
Significant differences reported between groups: "Intervention women tended to be younger, and were significantly more likely to speak English, more likely to be born in the USA, more likely to have had an abortion, more likely to report negative coping strategies, and more likely to report current tobacco use and drug use in the previous year" |
Low risk of bias |
Participants and people delivering the interventions would have likely been aware of their group allocation due to design of cluster RCT: "Women were not blinded to condition"
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 |
Some concerns |
8‐15% dropout from each cluster but outcome data available for both clusters
No evidence that the result was not biased by missing outcome data.
Reasons for dropout not reported. |
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
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 |
High risk of bias |
Overall high risk of bias due to bias in the timing of identification/recruitment of participants in the cluster RCT (individuals not identified/recruited before cluster randomization, participant selection may have been affected by knowledge of the intervention assigned to each cluster, some baseline imbalances), and additional concerns due to missing outcome data (moderate dropout) and potential bias in the measurement of outcome (self‐report) |
