Al Mazroui 2009.

Methods	Randomized controlled trial
Participants	The study location was Zayed Military Hospital, United Arab Emirates 120 participants were randomized to the intervention group and 120 participants were randomized to the control group The inclusion criteria were diagnosis of type 2 diabetes mellitus, receiving oral hypoglycemic therapy, hospital consultant consented to patient entering trial, patient provided written informed consent to their participation in the research The exclusion criteria were secondary forms of hypertension, serum creatinine > 184 mmol l‐1, macroalbuminuria > 300 mg 24 h‐1, history of cerebrovascular accidents, convulsive disorder, diabetic proliferative retinopathy or diabetic autonomic neuropathy
Interventions	Intervention: PHARMACIST CARE INTERVENTION For all patients randomized to the intervention group, the research pharmacist had discussions with their physicians regarding drug therapy and, if necessary, treatment modification was recommended, e.g. more intensive management of hypertension or simplification of dosage regimens if deemed appropriate, taking account of the latest American Diabetes Association (ADA) recommendations. Patients who were randomized to the intervention group were educated on their illness and their medication in a structured fashion, including discussion on risk of diabetes complications, proper dosage, side effects and storage of medications, healthy lifestyle and management of diabetes mellitus signs and symptoms through self monitoring. A printed leaflet to assist with the education program was developed and the patient was given a copy to take home. Supplementary leaflets containing information about hypertension and hyperlipidemia were also given to the patients if they suffered from these conditions. The educational advice was reinforced when patients came to the hospital pharmacy to collect their prescribed medicines on their monthly schedule. In addition, behavioral modification aspects of the Pharmacist Care intervention involved advice on the following: self monitoring of glycemic control (patients were encouraged to monitor their blood glucose levels 3 times per day, to record these values and bring a record book to all subsequent appointments); physical exercise (this involved initiation of an exercise plan that could be incorporated into the patient's daily schedule, after taking into consideration their level of fitness, e.g. 1‐hour walk daily; diet (the patient was assisted with the identification of dietary behavior that adversely influences blood glucose control, lipid levels, weight management, and of the times of day when the patient was most vulnerable to overeating, and given improved understanding of the relative effects of certain food choices on blood glucose control); medication adherence (patients were asked about any problems that they had encountered with regard to taking their medication and were offered education and practical help to encourage them to take the medicines prescribed for them by their physician); and smoking cessation (patients were encouraged to stop smoking by advising them about the danger of smoking to health, with emphasis on the increased dangers of smoking in diabetic patients) Control: USUAL CARE Control group participants received normal care from medical and nursing staff. They did not receive any pharmacy clinical service but received advice on self monitoring their blood glucose by medical or nursing staff
Outcomes	The measures of adherence were self report. Adherence was measured at baseline and 12 months using a standard protocol for questionnaire administration to reduce potential bias. Patients who reported forgetting doses, intentionally missing or taking extra doses were classed as non‐adherent. No account was taken of intelligent non‐adherence, i.e. when a patient decides for good reason, for example, to take an extra dose or miss a dose The patient outcomes were BMI, fasting blood glucose, HbA1c, blood pressure, cholesterol, health‐related QoL, and 10‐year risk assessments. BMI, blood work, and QoL scores were collected by the research pharmacist and/or clinical pharmacy staff at baseline and then every 4 months until the study was completed (12 months). 10‐year risk assessments were done at the end of the study using British National Formulary (BNF) prediction charts and the Framingham scoring method. These methodologies take account of age, gender, smoking status, total cholesterol, HDL, and systolic blood pressure
Notes	It is unclear what information was gathered at the face to face interview and what was gathered from a review of the medical charts
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information about the process of randomization: "After recruitment, patients were randomly assigned to one of two groups: intervention group or control group. The group allocations were carried out using restricted randomization with both groups being matched as closely as possible for gender and presence of hypertension i.e. diastolic blood pressure > = 90 mmHg (hypertensive) or < 90 mmHg (normotensive)" (pg 548)
Allocation concealment (selection bias)	Unclear risk	Insufficient information about the allocation process: "After recruitment, patients were randomly assigned to one of two groups: intervention group or control group. The group allocations were carried out using restricted randomization with both groups being matched as closely as possible for gender and presence of hypertension i.e. diastolic blood pressure > = 90 mmHg (hypertensive) or < 90 mmHg (normotensive)" (pg 548)
Selective reporting (reporting bias)	Unclear risk	No protocol available
Other bias	Unclear risk	No limitations are given
Blinding of outcome assessment (detection bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Insufficient information to permit judgment of 'Low risk' or 'High risk' of bias. No information about the blinding of data collectors is given
Blinding of outcome assessment (detection bias) Patient outcome	Unclear risk	(PRIMARY) BMI AND BLOOD TESTS CHART REVIEW ‐ Outcomes collected through a chart review. Unclear if staff extracting the data were blind
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Patient self report ‐ subject to bias. No mention of patient blinding
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) BMI AND BLOOD TESTS CHART REVIEW ‐ The lack of blinding of the study participant is not likely to affect this outcome
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Insufficient information to permit judgment of 'Low risk' or 'High risk' of bias. No indication of blinding of key study personnel
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) BMI AND BLOOD TESTS CHART REVIEW ‐ Outcomes collected through a chart review. Unclear if study personnel were blind
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Few dropouts; evenly across groups
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) BMI AND BLOOD TESTS CHART REVIEW ‐ Few dropouts; evenly distributed across groups