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. 2014 Nov 12;2014(11):CD009414. doi: 10.1002/14651858.CD009414.pub3

McFarlane 2000.

Methods 3‐arm trial. Quasi‐randomisation (clinics rotated through different interventions; “monthly sequential assignment.
Participants Setting: 2 prenatal clinics in SW USA. Each clinic served 2000‐3000 pregnant women each year and 97% were Hispanic.
Inclusion criteria: women who reported abuse in the year prior to or during current pregnancy by current or former male partner (mean gestational age at recruitment 18 weeks).
Exclusion criteria: not described.
Interventions 335 women agreed to participate. 96% women Hispanic – and only results for these 329 women are reported in this paper.
3 interventions:
  1. Brief intervention (control). Women were provided with a card with phone numbers for community resources to help with DV and information about personal safety planning. (No other counselling or education routinely offered) (n = 113).

  2. Counselling intervention group: unlimited access to counsellor with expertise in DV. Women could drop in to the maternity clinic or arrange appointments with the counsellor or reach the counsellor by phone or pager. The counsellor gave advice and support and assisted women in accessing other services. Counselling from recruitment in pregnancy up until delivery (n = 98).

  3. Outreach intervention: same counselling intervention as group 2 plus trained lay mentor who offered support and assistance in accessing services. The mentor was available to visit or by phone. The intervention was from recruitment in pregnancy up until delivery (n = 118).

Outcomes Follow‐up at 2, 6, 12 and 18 months post‐intervention (i.e. after delivery). Outcomes were reported abuse and use of resources. Abuse on Severity of Violence against Women Scale (SVAWS) a 46 item scale; 19 items on threats of violence and 21 items on physical violence and 6 items on sexual violence with 4 point response re how often the behaviour occurred – never (1) to many times (4). Possible scores 19‐76 on threats and 27‐108 on violence.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Women were allocated by clinic.
Allocation concealment (selection bias) High risk Women were allocated by clinic; it is possible that women attending the different clinics were different and the order in which staff delivered the interventions may have had an effect.  
Incomplete outcome data (attrition bias) 
 All outcomes High risk Results only reported for Hispanic women in the sample.
Results by intervention group were available for 259/329  women (79%) (> 20% missing data).
Selective reporting (reporting bias) Unclear risk Results in this paper for Hispanic women only – while they were 96% of the population it is not clear why other women were excluded or whether they were balanced across groups. Results are reported by gestational age at recruitment and over time – so there were a large number of possible correlations.   
Other bias Low risk Groups were described as similar at baseline. Other bias not apparent.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No mention of blinding; lack of blinding may have affected responses and other aspects of care.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No mention of blinding; lack of blinding may have affected responses and other aspects of care.