| Methods |
Patients (n = 255) were randomly assigned to (1) Pharmacist telephone follow‐up intervention (PTFI; n = 126) or (2) usual pharmacist intervention (UPI; n = 129). Randomization was stratified by pharmacy in balanced blocks of 10 patients (1:1 ratio) using a computer‐generated random number table and provided to the pharmacist investigators in sealed envelopes identified by patient number. Patients were randomized sequentially by patient number |
| Participants |
Patients had an expected duration of antibiotic treatment of 5 to 14 days, spoke French or English, were able to converse over the telephone, and were available for a telephone call during and at the expected end of antibiotic treatment and for up to 48 hours thereafter. Patients were excluded from the trial if they were initiating prophylactic antibiotic treatment, were not self managing their medication, were already participating in a clinical trial, in the opinion of the pharmacist, required intense clinical follow‐up, or would benefit from more intensive follow‐up in a special medical hospital clinic |
| Interventions |
Pharmacist telephone follow‐up intervention (PTFI) patients received a telephone call from a pharmacist on day 3 of their antibiotic treatment. The pharmacist documented the patient's general condition, checked for adverse effects and the patient's understanding of the dosage, stressed the importance of adherence to treatment, and offered encouragement. Patients were invited to ask questions and to contact their pharmacist if needed. At the initial pharmacy visit, Usual Pharmacist Intervention (UPI) patients were invited to contact their pharmacist if needed. They received no telephone calls during their treatment |
| Outcomes |
Compliance was measured by patients reporting the number of antibiotic tablets or capsules left. Compliance was defined as the percentage of tablets consumed of the total number of tablets provided. Patients receiving azithromycin treatment and those who had a change in antibiotics during their treatment were excluded from this analysis. The clinical outcomes of patients were measured by asking for the number of infectious symptoms and their descriptions; in addition, a 5‐point Likert scale was used to evaluate the severity of the infections. This was measured at baseline and upon completion of the treatment |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Low bias because "Randomization was stratified by pharmacy in balanced blocks of 10 patients (1:1 ratio) using a computer‐generated random‐number table and provided to the pharmacist investigators in sealed envelopes identified by patient number. Patients were randomized sequentially by patient number." (pg 558) |
| Allocation concealment (selection bias) |
Low risk |
Allocation concealment detailed and appropriate. (pg 558) "... using a computer‐generated random‐number table and provided to the pharmacist investigators in sealed envelopes identified by patient number. Patients were randomized sequentially by patient number." |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
Unclear risk |
Some limitations noted in discussion ‐ (pg 562) "because the access to clinical data was limited, the main study outcome consisted of a patient's subjective evaluation rather than microbiological cultures... Moreover, a significant proportion of the patients included in the study were probably suffering from viral infections. Because antibiotics are not efficacious against such infections, it is unlikely that optimizing antibiotic treatment would affect the symptoms of these patients. Indeed, in a secondary analysis, by excluding patients suffering from upper‐ or lower‐respiratory tract infections (the patients most likely to have viral infections), we observed a larger reduction in the number of infectious symptoms among PTFI patients." |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ The pharmacist that contacted patients to discuss adherence were blinded to group (pg 559) "The final evaluation was conducted over the telephone by a pharmacist blinded to the patient's assignment group." |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) NUMBER OF INFECTIOUS SYMPTOMS ‐ Pharmacist collecting data blinded to patient group (pg 559) "The final evaluation was conducted over the telephone by a pharmacist blinded to the patient's assignment group. The interview was scheduled for the expected last day of antibiotic treatment, except for patients on azithromycin treatment for five days, who were contacted on day 10; due to long tissue half‐life and large volume of distribution, therapeutic concentrations are maintained over a 10‐day period. 15 of the patient could not be reached, additional telephone calls were made at least three times a day for up to three days. To maintain blinding, the pharmacist who performed the final evaluation was different from the recruiting pharmacist and had access only to the patient's name and telephone number and the name and dosage of his or her antibiotic treatment. At the end of the interview, the pharmacist was asked if, in her opinion, blinding was maintained. If a DRP was identified at the final evaluation, the patient was referred to his or her treating pharmacist. The number of infectious symptoms and the infection severity score were evaluated as in the initial evaluation. The interviewing pharmacist did not have access to the initial evaluation and was unaware of the patient's diagnosis". |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Open‐label trial and self report of adherence is highly subjective |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) NUMBER OF INFECTIOUS SYMPTOMS ‐ Patient symptom severity and number of symptoms is subjective and patients were likely aware of their study group allocation |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No mention of blinding of study personnel |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) NUMBER OF INFECTIOUS SYMPTOMS ‐ No mention of blinding of other study personnel |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ 21 patients had missing data across the 2 groups. 7 and 15 each in intervention and control groups. Reasons for missing data not reported individually for 2 groups. Unable to predict if it would have made a difference. Hence, marked unclear |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) NUMBER OF INFECTIOUS SYMPTOMS ‐ The reasons for dropouts are unclear |
