Hoddinott 2012.
Methods | Pilot RCT, 2 arms with individual randomisation. | |
Participants | Setting: 69 women admitted to a maternity hospital in Scotland between July and October 2010. Inclusion criteria: women living in the 3 most disadvantaged postcode areas served by the hospital and giving the baby some breast milk at hospital discharge. Exclusion criteria: women under 16 or with serious medical or psychiatric problems or insufficient English to communicate by telephone. |
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Interventions | Intervention group: (35 women) proactive phone calls from hospital discharge up to 14 days by a member of the feeding team. The median number of calls per women was 8 calls and the median length was 3 minutes. The calls were to provide support. Women could also initiate calls themselves. Control group: (34 women) reactive phone calls made by women up to 14 days pp. Only 1 woman called for advice. |
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Outcomes | Breastfeeding or exclusive breastfeeding at 6‐8 weeks. Satisfaction with care. Cost of intervention and service utilisation. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by Internet randomisation sequence service set up by an independent statistician. Stratified by parity. |
Allocation concealment (selection bias) | Low risk | By independent statistician. Women were only aware of allocation if they received calls. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Women would be aware of calls and staff providing care may have been informed by women if they received calls. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Follow‐up at 6 weeks by researcher who was reported to be blind of study allocation and had no other contact with the women. Effect on outcomes of partial blinding unclear. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 69 women were randomised and 11 lost to follow‐up. It was stated that an ITT analysis was carried out for women with complete data at follow‐up. |
Selective reporting (reporting bias) | Unclear risk | Pilot study. Assessment from published study report. |
Other bias | Unclear risk | Women in the intervention group were on average 1 year older and more likely to be living in the most disadvantaged areas and hospital stays were slightly longer, otherwise groups were comparable. |