| Methods |
Randomized controlled trial: consenting patients were randomized to the ED (intervention) or pharmacy (control) group |
| Participants |
The study was conducted from November 2001 to May 2002. During the 6‐month study period, all adult patients (> 18 years old) presenting to the ED for whom an outpatient prescription for a macrolide antibiotic was being considered in discharge planning were eligible for the study. The need for outpatient treatment with an antibiotic was determined by the attending Emergency Physician who was primarily responsible for the patient. Patients who were unwilling or unable to give informed consent or were unavailable for telephone follow‐up were excluded from the study. In addition, all females of childbearing potential were given urine pregnancy tests, and pregnant or breast‐feeding females were excluded. 77 patients were recruited |
| Interventions |
Patients in the ED group were provided a full course of azithromycin (6 x 250 mg) at no charge and given instructions on the proper dose and frequency before discharge from the ED. Patients in the pharmacy group received a written prescription for a full course of azithromycin before discharge from the ED. To minimize the potential for economic bias, the patients were able to fill their prescriptions free of charge at a 24‐hour pharmacy located 8 blocks from the hospital |
| Outcomes |
The primary outcome was compliance of obtaining medication as determined by pharmacy records. A secondary outcome was compliance in completing the course of medication as determined by a telephone survey
Measurement of clinical health outcomes: return visits to the ED and hospitalization |
| Notes |
The prescription filling rate for the control group is based on the assumption that control patients used a participating pharmacy 8 blocks away that provided the drug free of charge and patients were apparently not asked if they filled their prescription elsewhere. The prescription filling rates could have been clarified for the control group. The "course completed" rate is based on self report on a telephone call and there was no indication that interviewers were blinded to group or if the exact question given. Technically, this study qualified for the review, but the reliability and credibility of these measures is suspect. This intervention may be impractical in any setting where giving drugs out for free is not possible |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Author's note: patients were randomized by random sequence generation through pharmacy who opened the envelope to determine if the subject was in the intervention or control group |
| Allocation concealment (selection bias) |
Unclear risk |
No mention of allocation concealment. (pg 313) "Patients who were enrolled in the study were randomized into the ED (intervention) or pharmacy (control) group." |
| Selective reporting (reporting bias) |
Low risk |
Author's note: We reported all outcomes that we measured: compliance by self report, compliance by pharmacy records, return ED visits, or hospitalization within 2 weeks |
| Other bias |
Unclear risk |
Limitations in discussion note other risks of bias. (pg 315) "The most important limitation of this study is the poor reliability of patient self reported compliance. This makes it difficult to draw conclusions on patient compliance beyond filling the prescription. Another limitation was the choice of a study medication, which is often prescribed for relatively benign, self limiting conditions, because spontaneous improvement in the patient's condition could further decrease compliance. The benign nature of disease in this population could have also limited the ability to find differences in patient morbidity and use of hospital resources as a result of noncompliance. Finally, small sample size and our urban setting limit the ability to generalize the results to larger populations or other ED settings." Author note: these limitations present an unclear risk of bias |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) PHARMACY RECORD ‐ No mention of blinding of outcome assessors ‐ not possible given the groups in this study (only one group received medicine from the pharmacy). (pg 313) "Pharmacy records were reviewed to determine whether patients in the pharmacy group had filled their prescriptions". No mention of other details like whether the records were electronic or paper‐based |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) RETURN VISIT TO ED/HOSPITAL ADMISSION ‐ No mention of blinding of outcome assessors, though this is unlikely to impact this outcome given its objective nature. (pg 313‐4) "The hospital's computerized record system was searched to identify enrolled patients who returned to the ED or were admitted to the hospital within 2 weeks of the index visit....as well as return visits to the ED and hospital admissions within 2 weeks of the index visit." |
| Blinding of participants (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) PHARMACY RECORD ‐ No explicit statement on blinding. Pharmacy group patients were required to fill their prescriptions at a pharmacy 8 blocks away and ED patients from ED itself. It is not known whether the fact that some of the patients were obtaining medicines from ED was concealed from the pharmacy group, a fact which could alter the outcome; hence unclear |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) RETURN VISIT TO ED/HOSPITAL ADMISSION ‐ No mention of blinding of outcome assessors, though this is unlikely to impact this outcome given its objective nature |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) PHARMACY RECORD ‐ True blinding impossible because medicines were dispensed from 2 different sites. There is no statement regarding the blinding; hence adjudged uncertain |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) RETURN VISIT TO ED/HOSPITAL ADMISSION ‐ No mention of blinding of outcome assessors, though this is unlikely to impact this outcome given its objective nature |
| Incomplete outcome data (attrition bias)
Adherence measure |
Low risk |
(PRIMARY) PHARMACY RECORD ‐ Incomplete data is evenly spread across the groups ‐ 4 in the ED group and 3 in the pharmacy group |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) RETURN VISIT TO ED/HOSPITAL ADMISSION ‐ Incomplete data is evenly spread across the groups ‐ 4 in the ED group and 3 in the pharmacy group |
