MacMillan 2009.
| Methods | Study design: randomised controlled trial Randomisation method: a table for each day/shift of the week was created for an 8‐week period and a random number table was used to determine the order of weeks 1 through 8 in the cells Power calculation: yes Study dates: from July 2005 to December 2006. Individual women were each followed up for 18 months, starting in July 2005 and ending in July 2008 |
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| Participants | Setting: 12 primary care sites (family practices and community health centres), 11 acute care sites (EDs) and 3 speciality care sites (obstetrics/gynaecology) Country: Canada Inclusion criteria: women aged 18 to 64 years, had a male partner at some time in the last 12 months, presented for their own healthcare visit, able to separate themselves from individuals who accompanied them, were living with 120 km of the site, were able to speak and read English, and able to provide informed consent Exclusion criteria: too ill to participate Number (%) of eligible recruited: 6743/8293 (81.3%) Numbers assigned: 6743; intervention group 3271, control group 3472 Number (%) of assigned that completed all healthcare visit questionnaires: 5681/6743 (84.3%); intervention group 2733, control group 2948 Number (%) with positive results and followed up: 707 (12.4%); intervention group 347, control group 360 Number of dropouts: intervention group 48, control group 148 Numbers analysed (and % with positive result) 411; intervention group 199 (57%), control group 212 (59%) *Age: intervention group mean 33.8 years (SD 10.8), control group mean 33.9 years (SD 10.7) Marital status: single/never married 41% Ethnicity: born outside Canada 11% Employment: working full‐ or part‐time 52% Income: annual income < CAD 25,000 47% Education: intervention group mean 13.7 years (SD 2.8), control group mean 13.5 years (SD 2.8) Children: ≥ 1 child at home 52% |
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| Interventions | Intervention group
Control group
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| Outcomes | Primary outcomes
Timing of measurement: followed up baseline (< 14 days), 6, 12, 18 months post‐intervention (collected through self report by women) We obtained clarification about the number of participants who discussed abuse with their provider (MacMillan 2015 [pers comm]) |
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| Notes | *Characteristics of participants are provided for the 707 women who had positive results for IPV in last 12 months. Age and education details for the group were obtained through personal communication (MacMillan 2011 [pers comm]) Funding: the Ontario Women's Health Council (Ontario Ministry of Health and Long‐Term Care) with investigator grants from Canadian Institutes of Health Research. Author Boyle held a Canada Research Chair in the Social Determinants of Child Health |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was by day or shift. "A table for each day of the week was created for an 8‐week period, and a random number table was used to determine the order of weeks 1 through 8 in the cells." This suggests there was balance across shifts and days of the week, and that systematic differences in presentation by day or shift were avoided |
| Allocation concealment (selection bias) | High risk | "The research coordinator created monthly calendars showing shift allocations for site coordinators." There is, therefore, a risk that advance awareness of shift/day allocations may have introduced selection bias in intervention assignment by not protecting the allocation sequence before and until assignment. For example, recruiters would likely have had knowledge of the allocation prior to inviting individuals into the study, which could have influenced their behaviours differentially |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | It was not possible to protect the allocation sequence after assignment given that participants "were told that they might be asked questions about their relationships by completing a form that may be passed on during this visit to the clinician, who might discuss their situation in more detail." Thus, participants may have had awareness that they were receiving an intervention (or not), which could have affected their performance. It was also not feasible to blind personnel to the allocation following assignment as they would have been prompted by the questionnaire placed in the patient record |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Interviewers blinded to group assignment met with women within 14 days of the index visit to conduct a baseline interview and again at 6, 12, and 18 months" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "Participant loss to follow‐up was high but evenly balanced: 43% (148/347) in screened women and 41% (148/360) in non‐screened women" over 18 months making a true ITT analysis difficult. It was noted by authors that women in the screened group who were LTFU reported higher scores on the WAST and CAS. Such differences between retained and lost were not observed in the non‐screened group. Thus, there is a possibility that the observed effect estimate is biased. In contrast, there were no group differences in proportions lost, or reasons for dropout, although those LTFU in the intervention group were more likely to be more severely abused. To deal with missing data, average growth measures were estimated from 5 complete files generated through multiple imputation to test the robustness of the observed findings for all enrolled women |
| Selective reporting (reporting bias) | Low risk | All outcomes for all time points reported. Trial was registered (NCT00182468) |
| Other bias | High risk | Protection against contamination: sites involved both screening (intervention group) and non‐screening (control group) shifts/days and therefore there is a risk that those who were in the control group could have received care that was influenced by physicians' prior experience of delivering the intervention |