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. |
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Interventions | 335 women agreed to participate. 96% women Hispanic – and only results for these 329 women are reported in this paper. 3 interventions:
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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. |