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. 2011 Sep 7;2011(9):CD006413. doi: 10.1002/14651858.CD006413.pub2

Trap 2001.

Methods Study design: CBA study (if comparing intervention groups 1 or 2 with the non‐random control group); Cluster RCT (if comparing intervention groups 1 and 2 with each other).
Duration of study: July 1996 to August 1997
Unit of allocation: Province (4 intervention, 3 control)
Method of allocation: Random allocation using balanced block design
Unit of analysis: Health facilities (48 intervention, 18 control)
Sampling: Multi‐stage: 8 districts randomly selected from intervention provinces and 48 intervention facilities randomly selected from these. From the 3 control provinces, 24 health facilities were selected from 6 districts. Intervention facilities were paired according to 'performance' at baseline and each facility in the pair randomly allocated to either Intervention 1 or Intervention 2. Also, 30 patients register from each clinic.
Participants Country: Zimbabwe
Income classification: Low‐income
Geographical scope: 7 provinces out of 8 provinces in the country
Rural/urban: Not stated
Setting: Health facilities
Supervisees: Health facility workers
Supervisors: Trained pharmacy technicians (n = 8) and pharmacists (n = 2)
Patients/clients: Patient records for each condition (acute respiratory infection, diarrhoea without blood, male urethral discharge, genital ulcer)
Interventions Stated purpose: Test the impact of supervision by specially trained pharmacy staff on stock management and adherence to standard treatment guidelines in health facilities
Description intervention 1: Supervisory visits by trained supervisors on stock management
Description intervention 2: Supervisory visits by trained supervisors on adherence to treatment guidelines
Control: No supervision
Training: National drug management supervisory programme (2‐week national training course for supervisors, followed by field work and 2‐day follow‐up course). Also national training programme on sexually transmitted infections being undertaken at same time.
Frequency of supervisory visits: Two supervisory visits, approximately 6 to 9 months after the baseline assessment in the intervention group
Co‐interventions: None
Outcomes Primary outcomes: Performance indicators on drug stock management and scores for adherence to standard treatment guidelines
Secondary outcomes: None
Time points when outcomes measured: 6 to 8 months after last supervision
Notes Funding: WHO Drug Action Programme, the International Network for Rational Drug Use and DANIDA.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk No if comparing intervention groups 1 or 2 with the non‐random control group. Yes if comparing intervention groups 1 and 2. “randomisation of health facilities using a balanced block design”
Allocation concealment (selection bias) High risk No if comparing intervention groups 1 and 2 with non‐random control ‐ as study design is CBA
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk No details provided
Incomplete outcome data (attrition bias) 
 All outcomes High risk Baseline: n = 24 for each study arm. Follow‐up: n = 23 (standard treatment guidelines), n = 21 (stock management), n = 18 (control)
Selective reporting (reporting bias) Low risk All outcome measures reported on
Other bias Unclear risk No mention on taking into account the multi‐stage sampling technique in the statistical analysis.
Baseline outcome measurements similar? High risk “When the pre‐intervention scores on both stock management and adherence to Standard Treatment Guidelines (STG) for the intervention, control and comparison facilities were compared there were no significant differences”. However, the baseline scores between the intervention group 2 (adherence to treatment guidelines) and the control are large: 19 point difference where the maximum scores are 100.
Baseline characteristics similar? Unclear risk Baseline characteristics not stated
Protection against contamination? High risk “Supervisors were asked not to discuss issues concerning the converse area of interest [i.e. stock management if supervising only adherence to treatment guidelines, and vice versa].
“At the same time as this supervisory activity was being undertaken, a national training programme on sexually transmitted infections (STI) was being undertaken, funded by the World Bank. As will be seen, this has a confounding effect on the results of the supervisory intervention.” “In addition, the effect of extraneous factors could not be taken into account. The stock management system was originally implemented with the primary aim of improving drug availability, but drug availability is strongly influenced by the supply performance of the central procurement office, which is the only supplier of drugs to the primary healthcare level. The possibility of private sector procurement did not exist. Overall drug availability from the central procurement office remained almost constant during the intervention and significant changes in this indicator did not occur”.
“Improved adherence to STG for genital ulcer disease was seen in all three groups.  This may have been achieved by other activities undertaken nationwide by the World Bank supported STI project and related to the new ZEDAP STD‐modules”.