| Methods |
Method of randomization not stated. The physician educating the patients was not blinded, whereas the office nurse questioning patients in the follow‐up period was blinded as to which patient was in which group |
| Participants |
All patients over 18 years treated with erythromycin for an acute illness were included, while patients with a history of allergy/intolerance to erythromycin were excluded |
| Interventions |
Informed patients were told of 6 possible side effects of treatment with erythromycin, while control (uninformed) patients were not made aware of potential side effects of treatment |
| Outcomes |
The occurrence of side effects both before and after treatment |
| Notes |
Adherence was measured using the following methods: the mean number of erythromycin pills taken per day, patients reporting that they missed at least one pill, and the mean number of pills taken out of 40 pills |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization process not described. (pg 62) "Patients were randomized to informed (study) and UP informed (control) groups." |
| Allocation concealment (selection bias) |
Unclear risk |
No mention of allocation concealment. (pg 62) "Patients were randomized to informed (study) and UP informed (control) groups." |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
Unclear risk |
Hawthorne effect possible. Physician not blinded. Small sample size. However, unclear |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Outcome assessor was blind. (pg 63) "The nurse did not know the identity of informed and uninformed patients." |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) SIDE EFFECTS ‐ Outcome assessor was blind. (pg 63) "The nurse did not know the identity of informed and uninformed patients." |
| Blinding of participants (performance bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Patients were blinded to group. Author's note: "To prevent bias, patients were blinded regarding the study. This was felt to be reasonable, as treatment decisions were not affected by inclusion, and all patients were treated within generally accepted standards of care." |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) SIDE EFFECTS ‐ Patients were blinded to group. Authors report that: "To prevent bias, patients were blinded regarding the study. This was felt to be reasonable, as treatment decisions were not affected by inclusion, and all patients were treated within generally accepted standards of care." |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Physician was not blind (pg 64) |
| Blinding of personnel (performance bias)
Patient outcome |
High risk |
(PRIMARY) SIDE EFFECTS ‐ Physician not blind. All the patients in the study were seen by the same physician |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Low rate of missing data. However, the distribution is not known, therefore uncertain |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) SIDE EFFECTS ‐ Low rate of missing data. However, the distribution is not known, therefore uncertain |
