Mehuys 2011.
Methods | Randomized controlled trial | |
Participants | The study location was 66 community pharmacies located in Flanders, Belgium 35 pharmacies and 153 participants were randomized to the intervention group and 31 pharmacies and 135 participants were randomized to the control group The inclusion criteria were: have a prescription for oral hypoglycemic medication, age between 45 years and 75 years, BMI over 25 kg/m2, treatment with oral hypoglycemic medication for at least 12 months, and a regular visitor of the pharmacy The exclusion criteria were age above 45, solely on insulin (no oral hypoglycemic) |
|
Interventions | Intervention: COMMUNITY PHARMACIST INTERVENTION
Patients in the intervention group received pharmacist‐led, individual education about type 2 diabetes and its complications, education about the correct use of oral hypoglycemic agents, facilitation of medication adherence, healthy lifestyle education (diet, physical exercise and smoking cessation), and reminders about annual eye and foot examinations. These elements were implemented at the first visit and at each prescription‐refill visit of the patient during the 6‐month intervention period Control: USUAL PHARMACIST CARE Patients in the control group received usual pharmacist care |
|
Outcomes | The measures of adherence were prescription refill rate used to calculated adherence rate (%) using the following formula: (total days supplied during the study ‐ days of last supply in the study) divided by (last claim date in the study ‐ first claim date in the study) x 100. Self reported adherence was assessed at the end of the study by asking patients: How often do you not take your oral hypoglycemic medication as prescribed? with permitted answers of (i) never, (ii) 1 to 2 times/year, (iii) 1 to 2 times/month, (iv) 1 to 2 times/week, or (v) daily The patient outcomes were (1) Fasting plasma glucose (FPG) based an average of 3 days' glucose day curve (i.e. 4 FPG measurements/day for 3 days, which was then averaged), at the start and at the end (24 weeks) of the study for control participants and at the start, 6, 12, 18, and 24 weeks for the intervention participants. (2) Glycosylated hemoglobin (HbA1c) provided by the participant's GP for the previous 6 to 9 months |
|
Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was performed at the pharmacy level. Each participating pharmacy was randomly assigned to either the control group or the intervention group. The sequence of allocation to control or intervention group was predetermined by the investigators based on a randomization table generated using SPSS 14.0 software (pg 603) |
Allocation concealment (selection bias) | Unclear risk | The sequence of allocation to control or intervention group was predetermined by the investigators based on a randomization table generated using SPSS 14.0 software (pg 603) |
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 | Low risk | (PRIMARY) PRESCRIPTION REFILL RATES ‐ This is an objective measure of outcome |
Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) FASTING BLOOD GLUCOSE ‐ This is an objective measure of outcome |
Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) HBA1C ‐ Objective measure not likely to be influenced by lack of blinding |
Blinding of participants (performance bias) Adherence measure | Low risk | (PRIMARY) PRESCRIPTION REFILL RATES ‐ This is an objective measure of outcome |
Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) FASTING BLOOD GLUCOSE ‐ Objective measure not likely to be influenced by lack of blinding |
Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) HBA1C ‐ Objective measure not likely to be influenced by lack of blinding |
Blinding of personnel (performance bias) Adherence measure | Low risk | (PRIMARY) PRESCRIPTION REFILL RATES ‐ This is an objective measure of outcome |
Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) HBA1C ‐ Objective measure not likely to be influenced by lack of blinding |
Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) FASTING BLOOD GLUCOSE ‐ This is an objective measure of outcome |
Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) PRESCRIPTION REFILL RATES ‐ Very few missing outcome data are provided |
Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) FASTING BLOOD GLUCOSE ‐ Reasons for non‐completion were: hospitalization (2), cancer diagnosis (1), cardiovascular accident (1), objection of the GP (1), patient no longer motivated (1) and lost to follow‐up (2) |
Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) HBA1C ‐ Low levels of complete data for each group, baseline and final HbA1c values for 51.5% of the control patients and 38.7% of the intervention patients (see 2.5) |