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. 2015 Jul 22;2015(7):CD007007. doi: 10.1002/14651858.CD007007.pub3

MacMillan 2006.

Methods Study design: quasi‐randomised controlled trial
Randomisation method: randomised clinic days or shifts
Power calculation: yes
Study dates: from May 2004 to January 2005
Participants Setting: 2 EDs, family practices, and women's health clinics
Country: Canada
Inclusion criteria: women were eligible for participation if they were: (1) 18 to 64 years old, (2) at the site for their own healthcare visit, (3) able to separate themselves from individuals who accompanied them, (4) able to speak and read English, (5) able to provide informed consent
Exclusion criteria: too ill to participate
Number (%) of eligible recruited: 2461/2602 (94.4%)
Numbers assigned: 2461 intervention group 853, control group one 769, control group two 839
Number of dropouts (varied by screening tool): intervention group 3.7% to 5.2%, control group one 3.5% to 5.7%, control group two 1.5% to 3.0%
Numbers analysed (varied by screening tool): intervention group 788, control group one 741, control group two 810 (CAS); intervention group 404, control group one 725, control group two 814 (PVS); intervention group 411, control group one 742, control group two 826 (WAST)
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: achieved education > 14 years 52%
Children: ≥ 1 child at home 52%
Interventions Intervention group
  • Face‐to‐face screening by the HCP using 1 of the 2 screening instruments randomly determined. Any disclosure became part of the clinical encounter and women were offered usual care


Control groups
  • Control group one: computer‐based self completed screening using the PVS and the WAST randomly ordered

  • Control group two: written self completed screening using the PVS and the WAST randomly ordered

Outcomes Primary outcomes
  • Identification (12‐month prevalence based on instrument compared to CAS)

  • Extent of missing data

  • Women's preference for screening approach

Notes Funding: the Ontario Women's Health Council (Ontario Ministry of Health and Long‐term Care). Authors MacMillan and Wathen held Canadian Institutes of Health Research grants/fellowships; Dr Boyle held a Canada Research Chair in the Social Determinants of Child Health
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A random number table was used to assign clinic shifts
Allocation concealment (selection bias) High risk "The research coordinator created calendars that informed site coordinators of the assignments." 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 appear to 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 The study did not specify a control condition and it was not feasible to blind participants from the method of screening they would receive. While any impact of non‐blinding on performance was likely to have been distributed similarly across the written and computerised groups (who were told their HCPs would be unaware of their responses), it may have influenced the performance of participants in the face‐to‐face arm since their providers conducted the screening and therefore "would necessarily be aware of women's responses." In this arm, it was also not feasible to blind personnel to the allocation following assignment as they would have been informed by the recruiter of the woman's participation
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Outcome assessment was unable to be blinded and based on women's responses to the screening instruments, self completion of the CAS, and their evaluation of the method. It was therefore subjective, although the extent of any systematic differences in responses is likely to be randomly distributed
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Data collection was conducted immediately following the treatment. Although there was slightly higher attrition (4%) in the face‐to‐face arm of the trial, overall attrition was low at 5%. Reasons for missing data were not supplied
Selective reporting (reporting bias) Low risk All specified outcomes reported. Trial was registered (NCT00336297)
Other bias High risk A higher proportion of women in the computer group were from the lowest income quintile and may have been more likely to both be abused and to disclose by computer