Humphreys 2011.

Methods	Study design: randomised controlled trial Randomisation method: women reporting risks for smoking, alcohol, drug use, and IPV were stratified by risk combination and randomly assigned by the computer (on which they completed a risk assessment) to intervention or usual care Power calculation: none reported Study dates: from June 2006 to June 2007
Participants	Setting: 5 antenatal clinics in San Francisco Country: USA Inclusion criteria: females aged 18 years and over, English speaking, < 26 weeks pregnant, receiving antenatal care at one of the participating clinics, and not presenting for first antenatal visit Exclusion criteria: none stated Numbers recruited/assessed for IPV risk: 410 Numbers randomised: 50; intervention group 25, control group 25 Number dropouts at exit interview: intervention group 3, control group 1 Numbers analysed (% recruited) at exit interview: intervention group 22 (88%), control group 24 (96%) Number dropouts at second interview: intervention group 5, control group 8 Numbers analysed (and % recruited) at second interview: 20 intervention group (80%), control group 17 (68%) Numbers analysed (sensitivity analysis): 50; intervention group 25, control group 25 Age: mean 27.7 years (SD 7.1), range 18 to 43 years Marital status: married/living with partner 38%, never married 46%, divorced/separated 16% Ethnicity: Latino 34%, Black 22%, White 30%, Other 14% Education: < high school 22%, high school 36%, some college 28%, college degree 12%
Interventions	Intervention group Computer‐based assessment (to check eligibility based on Abuse Assessment Screen and randomise women) was followed by video doctor plus provider cueing prior to antenatal consultation Control group Computer‐based assessment (to check eligibility based on Abuse Assessment Screen and randomise women) was not followed by the video doctor/provider cueing sheet; women simply proceeded to their antenatal appointment
Outcomes	Primary outcomes Patient‐provider discussion of IPV Helpfulness of IPV discussion Timing of measurement: short‐term assessment of outcomes (immediately after the intervention and again following antenatal visit 1 month later; data collected from women)
Notes	Analysis: no adjustment for clustering Funding: US Department of Health and Human Services National Institute on Drug Abuse (R01 DA 15597). The preparation of this manuscript was supported, in part, by a NIDA Center grant (P50 DA 009253)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Women were randomly assigned by the computer (on which they completed a risk assessment) to the intervention or control group: "Women reporting risks were stratified by risk combination and randomly assigned by the computer to intervention or usual care groups"
Allocation concealment (selection bias)	Low risk	Allocation was adequately concealed as only the computer had knowledge of the assignment and there was no opportunity to influence what groups women went into as the computer did the allocation immediately
Blinding of participants and personnel (performance bias) All outcomes	High risk	While some personnel may have become aware of the participant allocation (e.g. in order to place computer reports in medical records), the review authors judged that the outcome is not likely to be influenced by this lack of blinding. However, the printed report would have alerted physicians to the status of the woman in the intervention group and may have enhanced performance above and beyond how they might otherwise perform if they were to observe such a report but not be part of a research study
Blinding of outcome assessment (detection bias) All outcomes	High risk	During post‐visit interviews at baseline and 1‐month follow‐up, participants were asked "Did you talk about domestic violence with your doctor today?" which was used to indicate that a patient–provider discussion of IPV occurred. We were not given information on the level of blinding of the research assistant and, in any case, the allocation of the woman could very easily have been revealed during the outcome evaluation potentially biasing the research assistant's observations
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Of the 25 women in the intervention group, 3 (12%) did not provide baseline data and 5 (20%) did not provide data at 1‐month follow‐up. Of the 25 women in the control group, 1 (4%) did not provide baseline data and 8 (32%) did not provide data at 1‐month follow‐up. The sensitivity of the results to LTFU was assessed "by making the assumption that in the absence of outcome data, no discussion occurred." Reasons for dropout were not provided and it is therefore difficult to judge if there was a differential dropout across the groups
Selective reporting (reporting bias)	High risk	There were differences between the outcomes as reported in the trial registry (NCT00540319) and those reported here
Other bias	High risk	Protection against contamination: women assigned to the control group could have received an 'enhanced' usual care given that providers were consulting with women from both the intervention and control groups