Morgado 2011.

Methods	Randomized controlled trial
Participants	The study location was University Hospital of Cova da Beira, Covilha, Portugal 98 participants were randomized to the intervention group and 99 participants were randomized to the control group The inclusion criteria were all adults of 18 years or more with established diagnosis and under treatment for arterial hypertension regardless of BP control The exclusion criteria were dementia, pregnancy, and breastfeeding
Interventions	Intervention: PHARMACIST INTERVENTION PROGRAM In sessions at baseline (30 minutes) and 3 and 6 months follow‐up (20 minutes) the clinical pharmacist thoroughly interviewed the patient to identify problems with medication adherence, provided patient education and counseling, and provided advice to physicians regarding pharmaceutical care. Pharmacists could schedule additional visits as needed, and patients were encouraged to bring all empty medication blisters and boxes to visits Control: USUAL CARE Control group patients received usual care through the hospital clinic. Pharmacists were not involved in their care
Outcomes	The measures of adherence were a validated 5‐item adherence scale, derived from the Morisky 4‐item scale, which was measured at baseline and end of study (9 months) by clinical pharmacists (not blinded to study allocation). Low adherence was defined as answering Yes to at least 3 of the 5 questions The patient outcomes were the proportion of patients achieving blood pressure control according to the JNC 7 guidelines, reduction in systolic blood pressure, and reduction in diastolic blood pressure at 9 months. These outcomes were based on the mean of 2 consecutive measurements, measured by trained nurses blinded to group allocation, according to the published guidelines on proper blood pressure measurement issued by the Portuguese Society of Hipertension using a validated automatic blood pressure measuring devices (Omron M4‐I) and appropriate cuffs. Patient knowledge of target BP values and of hypertension risks were also evaluated. Patients were considered knowledgeable of target BP values if they knew both target BP figures (140/90 mm Hg for hypertensive patients without diabetes and CKD and 130/80 mm Hg for hypertensive patients with diabetes or CKD). They were considered knowledgeable of the negative impacts of hypertension to health if they mentioned at least 2 potential major negative consequences of uncontrolled hypertension to health
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random numbers were used. "Participants were allocated following simple randomisation procedures (equal allocation and without restrictions) using a computer‐ generated list of random numbers." (pg 133)
Allocation concealment (selection bias)	Low risk	The allocation sequence was concealed from the clinical pharmacist enrolling and assessing participants in sequentially numbered, opaque, sealed envelopes. The computer‐generated the allocation sequence and the envelopes were prepared by a researcher with no clinical involvement in the trial
Selective reporting (reporting bias)	Low risk	The primary outcome measures with respect to pharmaceutical care efficacy were the proportion of patients achieving BP control and reduction in baseline SBP and DBP. The secondary outcome measure was antihypertensive medication adherence, which was determined in both arms by a pharmacist using a validated 5‐item adherence scale, derived from the 4‐item scale developed by Morisky et al
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	High risk	(PRIMARY) 5‐ITEM VALIDATED QUESTIONNAIRE ‐ The pharmacist was not blinded. "Pharmacists and physicians were aware of the patient allocated arm". (pg 133)
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) PROPORTION OF PATIENTS WITH CONTROLLED BP ‐ Nurses who were measuring blood pressure were blinded to group allocation
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) 5‐ITEM VALIDATED QUESTIONNAIRE ‐ "Based on the nature of the intervention, it is not feasible to blind hypertensive patients in pharmaceutical intervention models. Thus, whereas patients, pharmacists and physicians were aware of the patient allocated arm, nurses assessing BP were kept blinded to the allocation." (pg 133)
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) PROPORTION OF PATIENTS WITH CONTROLLED BP ‐ Lack of patient blinding unlikely to affect this outcome
Blinding of personnel (performance bias) Adherence measure	High risk	(PRIMARY) 5‐ITEM VALIDATED QUESTIONNAIRE ‐ The pharmacist was not blinded. "Pharmacists and physicians were aware of the patient allocated arm". (pg 133)
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) PROPORTION OF PATIENTS WITH CONTROLLED BP ‐ All personnel except nurses were unblinded. "Based on the nature of the intervention, it is not feasible to blind hypertensive patients in pharmaceutical intervention models. Thus, whereas patients, pharmacists and physicians were aware of the patient allocated arm, nurses assessing BP were kept blinded to the allocation." (pg 133)
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) 5‐ITEM VALIDATED QUESTIONNAIRE ‐ Analysis with most 'pessimistic' outcome values for patients dropping out was done, conclusions did not change
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) PROPORTION OF PATIENTS WITH CONTROLLED BP ‐ Only 3.6% of patients dropped out; intention‐to‐treat analyses did not change conclusions based on on‐treatment analyses