Hirsch 2014.
Methods | Randomised trial | |
Participants | 667 participants with hypertension (intervention 339; control 328) University general internal medicine clinic California USA Year of study: July 2010 to June 2012. |
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Interventions | Quote "Intervention patients received 4 x 30‐minute pharmacist visits (baseline, 3, 6, and 9 months). The pharmacist assessed the patient’s knowledge of hypertension, current treatment and treatment goals, self‐monitoring behavior, medical and medication history, and current medications. The pharmacist helped the patient to set individual BP goals, reviewed and/or ordered laboratory tests, made adjustments to the antihypertensive‐medication regimen. Each visit was documented. During subsequent visits, the pharmacist reviewed progress laboratory values, adherence, and self‐monitoring behavior and continued to make changes to the antihypertensive‐medication regimen as needed. A physician was always present in the practice and available for consultation as needed." Duration: 9 months |
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Outcomes | % achieving target blood pressure Systolic blood pressure (BP) Diastolic BP |
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Notes | Funding source:This research was funded by National Institutes of Health (NIH)/National Heart, Lung and Blood Institute grant no. 1RC2HL101811‐01 and by NIH grant nos. UL RR031980 and UL1TR000100. Conflict of interest: None stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Eligible patients were randomly assigned, by a computer‐generated random sequence, to either the intervention group or the usual‐care group. |
Allocation concealment (selection bias) | High risk | Intervention group participants were randomised before being invited to participate. Control participants were not contacted as no additional care/measurement took place. Many intervention participants declined to participate, creating significant potential for bias. |
Blinding of participants and personnel (performance bias) All Outcomes/Outcome 1 | Low risk | Unlikely to affect, objective outcomes |
Blinding of outcome assessment (detection bias) All Outcomes/Outcome 1 | High risk | Quote: "In the PharmD‐PCP MTM [intervention] group, the pharmacist measured the blood pressure (BP) at the beginning of each study visit, as was standard practice for all internal medicine clinic patients, whereas the nursing staff measured BP in the usual‐care patients." Systematic differences in measurement likely to create detection bias |
Incomplete outcome data (attrition bias) All outcomes | High risk | Between group attrition > 30%. |
Selective reporting (reporting bias) | Low risk | All reported |
Other bias | High risk | Additional inclusion criteria were applied to the intervention group after randomisation. Quote: "An additional inclusion criterion of having had a clinic visit in the 6‐month period before screening was applied to ensure that data from only patients who continued to receive primary care pharmacist care for at least 9 months after the index visit were included." |