| Methods |
A total of 77 patients were randomized, with 34 in the usual care group and 43 in the pharmacist‐provider intervention group |
| Participants |
Eligible patients included all adults at least 18 years of age and older with type 2 diabetes, taking at least 1 oral diabetes medication, with a glycosylated hemoglobin (HbA1c) result > or = to 9%. Non‐English speaking subjects, those with unstable psychiatric conditions, or patients with a terminal prognosis within 6 months were not eligible |
| Interventions |
The pharmacist intervention entailed the development of a diabetes care plan (DCP), regular pharmacist‐patient communication on diabetes care progress, and pharmacist‐provider communication on the subject's diabetes care progress. Medication‐related problems requiring intervention were identified as part of the DCP. The pharmacist intervention was initiated 1 week after the baseline interview with an in‐person appointment to develop the DCP that was then communicated to the primary care provider using electronic notation in the medical record. The pharmacist maintained regular contact with the subjects with weekly in‐person or telephone meetings. Once the patient and pharmacist determined that the diabetes care needs were progressing as outlined in the DCP, follow‐up phone call frequency was reduced to monthly through the 6‐month intervention period. Patients in the usual care group were instructed to continue normal care with their primary care provider |
| Outcomes |
HbA1c was used as the clinical endpoint and assessed at baseline, 6 months, and 12 months. Diabetes knowledge and quality of life with diabetes were assessed using a brief sample of questions used for identifying opportunities for diabetes care support and developing the DCP. Diabetes care history, adherence challenges, self management skills, and diabetes knowledge were assessed at baseline during an in‐person interview. Medication appropriateness of all prescribed drugs was assessed from the medical record by the Medication Appropriateness Index (MAI). Adherence was assessed at baseline, 6 months, and 12 months using a self reported, 2‐question recall technique. Medication use history was collected at baseline, 6 months, and 12 months |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization was not described in detail. "Subjects were enrolled in blocks of 4 from each of the 8 clinics until achievement of the target sample." (pg 434) |
| Allocation concealment (selection bias) |
Unclear risk |
No information was provided about how allocation was handled |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias |
Low risk |
The study seems to be free of other types of bias |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ The authors do not report who conducted the questionnaire interview. "A pharmacist trained in the use of the MAI and not working directly with the study subjects assessed the MAI at baseline and 6 months (end of the intervention), with follow‐up evaluation by the intervention pharmacist at 12 months" (pg 434) |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) HBA1C ‐ This is an objective measure of outcome |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Patients unblinded due to the nature of the intervention; this is a subjective measure |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) HBA1C ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ intervention pharmacist maintained regular contact with the subjects and with the primary care physicians; therefore, both were not blinded |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) HBA1C ‐ This is an objective measure of outcome |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ At 6 months missing data equal across groups, imbalance at 12 months. ITT using GEE (generalized estimating equations) was used. "The GEE method does not require imputation of missing data" (pg 435) |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) HBA1C ‐ There is not enough information given on the reasons for dropouts |
