| Methods |
Random allocation without an indication of concealment |
| Participants |
All children (aged 1 to 15) presenting to a pediatric outpatient clinic with streptococcal pharyngitis were included except those known to have received previous antimicrobial therapy of any type during the previous month, or those known to be allergic to penicillin |
| Interventions |
The parents of the 'normally informed' group were given instructions that the penicillin was to be taken 3 times per day for 10 days, and any questions that they had were answered. Parents of the 'optimally informed' group received specific counseling stressing the necessity that the penicillin be taken for the full 10 days in order to achieve the best cure/prevent relapse, and further, were given written instructions |
| Outcomes |
There was a single measurement of adherence: Sarcina lutea growth inhibition by urine (a test for the presence of antimicrobial activity). Throat cultures were obtained at 9 days, 3, and 6 weeks post‐treatment. In addition, the incidence of relapse was estimated in the various patient groups |
| Notes |
There was no indication of blinding of the outcome measures |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No mention of method of randomization. (pg 657) "...during this period were randomly assigned to one of three treatment groups." |
| Allocation concealment (selection bias) |
Unclear risk |
No mention of allocation concealment |
| Selective reporting (reporting bias) |
Low risk |
Clear the studies report all prestated outcomes; although, protocol is not available. (Study is from 1972) |
| Other bias |
Low risk |
No obvious other types of bias |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) URINE DRUG CONCENTRATION ‐ Not enough information in the article to assess blinding, but assessment is unlikely to be affected by lack of blinding |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) FAILURE AND RELAPSES ‐ Not enough information in the article to assess blinding, but assessment is unlikely to be affected by lack of blinding |
| Blinding of participants (performance bias)
Adherence measure |
Low risk |
(PRIMARY) URINE DRUG CONCENTRATION ‐ Not blinded, but assessment is unlikely to be affected by lack of blinding |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) FAILURE AND RELAPSES ‐ No blinding, but assessment is unlikely to be affected by lack of blinding |
| Blinding of personnel (performance bias)
Adherence measure |
Low risk |
(PRIMARY) URINE DRUG CONCENTRATION ‐ Not enough information in the article to assess blinding, but assessment is unlikely to be affected by lack of blinding |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) FAILURE AND RELAPSES ‐ Not enough information in the article to assess blinding, but assessment is unlikely to be affected by lack of blinding |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) URINE DRUG CONCENTRATION ‐ Reasons and losses to follow‐up not described |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) FAILURE AND RELAPSES ‐ We do not know to which study arms the dropouts belong |
