Lumley 2006.
| Methods | Cluster‐randomised trial of 3 years. Collaborating partners Lead agency: Local authority. Strategic involvement (policy making and service planning): Primary and secondary health care, health promotion, social services, environmental public protection services. Commissioning (implementing strategy taking account of resources available): No evidence of additional collaboration at this level. Operational (providing services directly): Primary and secondary health care, health promotion, social services, environmental public protection services, sport and leisure services, voluntary agencies. Set in Australia. |
|
| Participants | 16 out of 33 eligible local government authority areas in Victoria were matched into pairs. Women giving birth in these areas between 7 February 2000 and 5 August 2001 were sent postal questionnaires six months after the birth. Mothers whose infants had died were excluded. Questionnaires were returned by 6248 mothers in intervention states (out of 10,471 mailed, 61.6% response rate) and 5057 mothers in control states (out of 8722 mailed, 60.1% response rate). Age range: Intervention group (%) Control group (%) >20 yrs 1.6 1.1 20 ‐ 24 9.2 7.6 25 ‐ 29 27.8 26.3 30 ‐ 34 37.9 39.4 >34 21.5 23.8 Missing 2.0 1.8 |
|
| Interventions | The trial followed the PRISM (Program of Resources, Information and Support for Mothers) approach. A small steering committee of key stakeholders (local government, GPs, Maternal and Child Health Nurses, community and consumer organisations) was locally appointed to coordinate the implementation of the intervention, supported by a community development officer (CDO) in each intervention community. Ideas were shared between the intervention states through newsletters and other communications. Clinical audits were conducted. The intervention consisted of two components, one directed to primary care, the other to community services (local government and community agencies). Interventions were varied but included: Education and training programmes for maternal and child health nurses and general practitioners Local co‐ordination Mothers' Information Kits and vouchers Booklet developed by fathers for fathers Making environments more mother‐and‐baby friendly Befriending strategies for mothers through breaking down isolation and increasing opportunities to meet and make friends. |
|
| Outcomes | EPDS, a 10‐item scale for use in the postnatal period in which a score > 12 identifies probable depression SF36 physical and mental component scores at 6 months |
|
| Notes | Power calculations suggested 2337 participants were needed in each arm but this was adjusted upwards to account for cluster randomisation design. Aimed to invite 9600 women to participate in each arm and achieved this for the intervention arm but not for the control arm, despite prolonging the recruitment period. Additional resource requirements included employment and training of Community Development Officers and the production and distribution of information packs. Overall risk of bias was low. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | Individual consent to participate was not requested so population (intervention group and control group) was not aware of the trial |
| Blinding (performance bias and detection bias) All outcomes | High risk | There was no blinding but outcome was not influenced by this. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Participant flow diagram given |
| Selective reporting (reporting bias) | Low risk | Results presented in full |
| Other bias | Low risk | |
| Randomisation adequately described/protected? | Low risk | Local government authorities were stratified into rural and metropolitan areas and all possible pair matches were identified. From these possible pair matches in each stratum one set of eight pairs of areas was randomly selected. |
| Protection against contamination? | Low risk | Some in the comparison group received the information packs given to mothers in the intervention group but the relative impact of this would be small as the intervention included many other components. |
| Follow‐up rate adequate? | Low risk | Follow‐up rate of women > 60% and balanced in both arms. No clusters were lost from the study. |
| Reliable primary outcome measure? | Low risk | Validated measures used. |
| Groups measured at baseline? | Low risk | Sociodemographic profiles of intervention and control communities were presented (Table 1). |
| Appropriate choice of controls (CBA studies only)? | Unclear risk | Not applicable |
| Contemporaneous data collection (CBA studies only)? | Unclear risk | Not applicable |
| IS THE STUDY AT LOW RISK OF BIAS? | Low risk | OVERALL RISK OF BIAS WAS LOW |