Jarab 2012 a.
| Methods | Randomized controlled trial | |
| Participants | The study location was an outpatient diabetes clinic at Royal Medical Services Hospital, Amman, Jordan 85 participants were randomized to the intervention group and 86 participants were randomized to the control group The inclusion criteria were 18 years of age or older, treated at RMS Hospital and diagnosed with type 2 diabetes at least 1 year previously, took at least 1 prescribed medication for diabetes, and had an A1c level exceeding 7.5% The exclusion criteria were diagnosed with convulsive disorder, diabetic proliferative retinopathy, or diabetic neuropathy as reported in their medical files |
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| Interventions | Intervention: PHARMACIST INTERVENTION
Patients in the pharmacist intervention group received structured patient education and discussion about type 2 diabetes, risks and complications from diabetes, the prescribed drug therapy, proper dosage, side effects, and the importance of medication adherence. The pharmacist also emphasized lifestyle management (changing unhealthy dietary habits that affect blood glucose, blood pressure and lipid levels; regular physical activity; and monitoring and record blood glucose levels). Smokers were referred to a hospital‐run smoking cessation program. A special booklet on diabetes and lifestyle changes was given to each patient. 8 weekly telephone calls were made by the pharmacist to discuss and review prescribed therapy, emphasize the importance of adherence, and to answer patient questions or address concerns. Each call average 20 minutes Control: USUAL CARE Control patients (n = 85) received usual care by medical and nursing staff (patient assessment; 3‐ or 6‐month blood glucose and blood pressure measurements; advice on self monitoring blood glucose, and nutrition counseling) |
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| Outcomes | The measures of adherence were self reported, as measured by Morisky Scale. This simple, validated 4‐question survey assessed the likelihood that patients take their medications as prescribed. To score the questionnaire, each "yes" response is given a score of 1, and each "no" response is given a score of 0 (range 0 to 4). According to the Morisky classification, adherence is divided into 3 groups: high for those scoring 0, medium for those scoring 1 or 2, and low for those scoring 3 or 4, when scoring one point for each "yes" answer. For the purpose of the present analysis, the patients were divided into 2 groups: those scoring 0 were considered adherent, and those scoring 1 to 4 were deemed non‐adherent The patient outcome was A1c and the secondary outcomes were systolic and diastolic blood pressure, lipid values, and BMI as measured by the patient's physician at 6‐month follow‐up |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patients were randomly assigned to intervention and control groups via a minimization technique using Minim software (available for free download)." (pg 518) This software helps to minimize imbalances between intervention and control groups |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described. "Study participants were randomly assigned to intervention and control groups via a minimization technique using Minim software (available for free download). The patients were recruited over a period of 4 months from January through April 2011, and the last follow‐up was performed on October 27, 2011. The study received approval from the Institutional Review Board, King Hussein Hospital, Royal Medical Services, Jordan." (pg 518) |
| Selective reporting (reporting bias) | Unclear risk | No protocol and study objective (pg 518) is vague regarding what outcomes were sought: "The objective of the present study was to evaluate the impact of a clinical pharmacist‐led pharmaceutical care program on different clinical outcomes and self management behavior in outpatients with type 2 diabetes in Jordan." |
| Other bias | Unclear risk | Limitations noted by the authors: First, this study used a patient‐reported measure of medical adherence, and the results may be affected by social desirability and recall bias. Second, although the study outcomes were statistically more favorable in the intervention group compared with usual care, the study was underpowered because the trial enrolled a small number of patients due to limited availability of a single investigator |
| Blinding of outcome assessment (detection bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Insufficient information about blinding of data collectors to permit judgment of 'Low risk' or 'High risk' of bias |
| Blinding of outcome assessment (detection bias) Patient outcome | Unclear risk | (PRIMARY) A1C ‐ Blinding not mentioned |
| Blinding of participants (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Insufficient information about blinding of participants to permit judgment of 'Low risk' or 'High risk' of bias |
| Blinding of participants (performance bias) Patient outcome | Unclear risk | (PRIMARY) A1C ‐ Blinding not mentioned |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Insufficient information about blinding of key personnel to permit judgment of 'Low risk' or 'High risk' of bias |
| Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) A1C ‐ Blinding not mentioned |
| Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) A1C ‐ Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups |