Carter 2008.
| Methods | Randomised trial | |
| Participants | 243 hypertension patients (intervention 127; control 116) 5 primary care clinics (intervention 2; control 3). Iowa, USA Year of study: January 2004 to October 2006. |
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| Interventions | Intervention to address suboptimal medication regimens and poor medication adherence; through strategy planning, adherence aids, and home monitoring. Encouraged to attend 4 clinic meetings on top of baseline interview over 8‐month period, with optional additional visits or phone support | |
| Outcomes | Systolic and diastolic blood pressure (BP) at 4 and 9 months | |
| Notes | Funding source: National Heart, Lung, and Blood Institute (HL069801). Dr Carter supported by the Center for Research in Implementation in Innovative Strategies in Practice (CRIISP), Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service (HFP 04–149). Conflict of interest: Not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation of clinics was performed using a table of random numbers. |
| Allocation concealment (selection bias) | Unclear risk | No information relevant to concealment of allocation provided. |
| Blinding of participants and personnel (performance bias) All Outcomes/Outcome 1 | High risk | Neither participants nor personnel were blinded. This may have led to extra intervention changes. |
| Blinding of outcome assessment (detection bias) All Outcomes/Outcome 1 | Low risk | Quote: "Two different research nurses were dedicated to patients in either control sites or intervention sites to minimize contamination.", "Individual data elements were double‐entered into a database by a blinded data management team that included data technicians, the data manager, and the biostatistician" and "The 24‐hour results were used as a blinded objective outcome and were not made available to either the patient’s physician or the clinical pharmacist until the patient completed the trial". |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis |
| Selective reporting (reporting bias) | Low risk | Typical/planned BP measures reported |
| Other bias | Low risk | None identified |