| Methods |
If children coming in on Monday received pre‐packed tablets, those who came in on Tuesday received syrup. The formulation assigned to a particular day changed from week to week. 155 received pre‐packed chloroquine tablets, and 146 received syrup |
| Participants |
Children aged 0 to 5 years diagnosed with malaria at the clinic over a 6‐week period received either pre‐packed tablets or syrup by random assignment (n = 301) |
| Interventions |
Chloroquine tablets were dispensed in polythene packages divided into 3 parts each containing the daily dose. The brand of tablets used for this study easily dissolved in water to form a homogenous suspension. Caregivers were advised at the dispensary to crush the tablets and to add a little honey or sugar to the mixture to mask its bitter taste. Staff of the health centers pre‐packed the chloroquine on a weekly basis. Packages were available for 8 treatment regimes based on weight. The other group got chloroquine syrup |
| Outcomes |
The measure used to dispense the medication (in the case of syrups), frequency, and duration of administration. A standard graded measuring syringe was used to assess the volume of the implement used for measuring the dose at home, and then compared adherence to treatment and its cost between the 2 groups |
| Notes |
The investigators varied which day of the week was assigned to which intervention, making this trial closer in methodology to a cluster‐randomized trial |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization based on day of the week. (pg 497) "All caregivers visiting the two health centres over a 6‐week period whose children had malaria received either pre‐packed chloroquine tablets or chloroquine syrup by random assignment..... Thus if children coming in on Monday received pre‐packed tablets, those who came in on Tuesday received syrup. The formulation assigned to a particular day changed from week to week." |
| Allocation concealment (selection bias) |
Unclear risk |
(pg 497) "Thus if children coming in on Monday received pre‐packed tablets, those who came in on Tuesday received syrup. The formulation assigned to a particular day changed from week to week." |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
Unclear risk |
Insufficient information provided |
| Blinding of outcome assessment (detection bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No blinding of staff and personnel |
| Blinding of outcome assessment (detection bias)
Patient outcome |
High risk |
(PRIMARY) RECOVERY ‐ No mention of blinding of data collectors |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Patients could not be blinded due to the intervention |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) RECOVERY ‐ Patients were not blinded to study groups |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No blinding of key study personnel |
| Blinding of personnel (performance bias)
Patient outcome |
High risk |
(PRIMARY) RECOVERY ‐ No mention of blinding of study staff |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Insufficient information provided |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) RECOVERY ‐ No reasons given for missing outcome data |
