Rowe 2009.
Methods |
Study design: Cluster RCT Duration of study: July‐October 1999 to July‐October 2004 Unit of allocation: Geographical area (1 intervention, 1 control) Method of allocation: Random Unit of analysis: Ill‐child consultation (288 at baseline; numbers in intervention and control group not specified) Sampling: Public and private licensed health facilities providing IMCI ‐level outpatient services to children |
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Participants |
Country: Benin Income classification: Low‐income Geographical scope: South‐eastern Benin Rural/urban: Mixed ‐ rural and urban Setting: Health facilities Supervisees: Nurses, nurse aides and physicians Supervisors: 8 Physicians Patients/clients: Children up to 5 years |
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Interventions |
Stated purpose: Improve adherence to IMCI guidelines Description intervention: Multi‐faceted intervention: Training of health workers in IMCI plus an enhanced package of follow‐up support, including: 1) 5‐day workshop for the protocol (training of supervisors, supervisory visits, checklist and supervision of supervisors. 2) Printed job aides: patients registers and counselling guide. 3) Half‐day training for health workers on use of job aides and supervision checklist. 4) Non‐financial incentives (framed certificates, publicity for best performing health worker). 5) When realised that very little supervision was occurring, 1‐ to 3‐day workshops every 3 months to present supervision results. Control: Training of health workers in IMCI plus usual package of support 1) Supervision (training of supervisors, supervisory visits) 2) Printed job aides (IMCI recording forms) Training: Training on IMCI for health workers. Courses of 24 to 25 participants: participant‐to‐trainer ratio 4:1. Course held in 2001, 2002, 2004 and 2004. 5‐day training of supervisors Frequency of supervisory visits: Recommended 2 supervisory visits every 3 months, but only 29% of scheduled visits occurred Co‐interventions: 5 vehicles for supervision, process of decentralisation where supervisors given some control over budgets and sharing of results of surveys at least annually |
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Outcomes |
Primary outcomes: 1) % of children receiving recommended care. 2) % of children receiving recommended or adequate care. 3) % of needed IMCI tasks that were performed Secondary outcomes: None Time points when outcomes measured: Baseline ‐ 1999. Follow‐up 2001, 2002 and 2004 |
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Notes |
Funding: USAID's Africa Integrated Malaria Initiative Problems noted in the study: Only 29% of supervisory visits actually took place and there was a slow implementation of IMCI training of health workers Supervision protocol:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "We randomly chose a slip of paper from a bag to assign [each area to the study arms]" |
Allocation concealment (selection bias) | Low risk | Allocation performed at start of the study |
Blinding (performance bias and detection bias) All outcomes | High risk | “The study was unblinded because it was impossible to conceal the study supports from health workers and surveyors” |
Incomplete outcome data (attrition bias) All outcomes | High risk | Greater loss to follow‐up in intervention area (Table 2): only 54/72 health facilities surveyed in intervention area in 2004 compared to 46/58 in control area. |
Selective reporting (reporting bias) | Low risk | All outcomes stated in methods section reported on |
Other bias | High risk | Does not meet EPOC inclusion criteria of minimum of 2 intervention and 2 control sites “Our study had other potential limitations. First, observation of consultations could have influenced health worker practices, perhaps overestimating quality somewhat; this influence would likely have affected all study groups similarly. Second, prescriptions were sometimes incomplete, which probably led to the underestimation of quality for some consultations. Our sensitivity analysis suggested some bias effect sizes, but overall conclusions were not affected” |
Baseline outcome measurements similar? | Low risk | On ITT analysis (Figure 2), the control area had 6 percentage points more children receiving recommended care. All other outcomes similar. |
Baseline characteristics similar? | Low risk | "Characteristics of the study groups were similar, except that children in control areas were more significantly more often seen by a IMCI trained health worker in the follow‐up period (P = 0.003)" |
Protection against contamination? | Low risk | Control group unlikely to have received the intervention |