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. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4

Powers 2011.

Methods Randomized controlled trial
Participants The study location was Durham, North Carolina, USA
45 participants were randomized to the intervention group and 44 participants were randomized to the control group
The inclusion criteria were enrolled in primary care for at least 1 year; age = 55 years; had a diagnosis of hypertension based on International Classification of Diseases 401.0, 401.1, or 401.9; received a prescription for hypertensive medication in the previous year; had systolic blood pressure N140 or diastolic blood pressure N90 based on their most recent blood pressure measurement within the last 12 months; and had an electrocardiogram within the last 5 years to evaluate the absence or presence of left ventricular hypertrophy
The exclusion criteria were hospitalized for a myocardial infarction or coronary artery revascularization or had a diagnosis of metastatic cancer in the past 6 months; had a history of stroke; had active diagnosis of psychosis or dementia documented in medical record; were participating in another chronic disease self management study; were resident of a nursing home; or did not have access to a telephone
Interventions Intervention: PERSONALIZED RISK COMMUNICATION
 Patients in the personalized risk communication arm received standard risk factor education (control) as well as personalized information based on their Framingham CHD and stroke risk score, presented verbally and in graphic form as vertical bar charts. Patients' average and optimal CHD and stroke risks based on published estimates for their 5‐year age group were also presented in graphical form alongside their estimated risk. To achieve optimal risk, patients were presented with potential strategies to improve their risk through risk factor modification such as medication and patient lifestyle factors. A copy of the patient's personal risk information was also provided to the primary care provider
Control: STANDARD RISK FACTOR EDUCATION
 Control patients received written patient education materials from the American Heart Association/American Stroke Association entitled "Are You at Risk of Heart Attack or Stroke?", which reviewed risk factors and how these factors can be improved but did not provide personalized estimates of individual risk. The research assistant verbally reviewed the information with all patients and answered any questions at the initial visit
Outcomes The measures of adherence were measured at baseline and 3 months by means of the Morisky test. The questionnaire was administered by research assistants
The patient outcome was knowledge of cardiovascular risk factors and measured by asking patients to name as many risk factors as they could. Results are reported as the number of correctly identified risk factors. Patients were masked to their calculated risk scores and asked to estimate their 10‐year stroke risk, 10‐year risk for a CHD event, as well as their level of worry for each type of event on a continuous scale ranging from 1 to 100. The interview was conducted by research assistants at baseline and 3 months postintervention. The patient outcomes were risk factor knowledge, perceived stroke risk, perceived CHD risk, stroke worry, CHD worry SBP and DBP, 10‐year CHD risk estimate, 10‐year stroke risk estimate. All the measurements were conducted by research assistants at baseline and 3 months post intervention. Patients' resting blood pressure was measured twice using a digital blood pressure monitor, and the mean was used for the longitudinal analysis. A patient's Framingham stroke and CHD risk estimates were calculated at baseline and 3 months postintervention based on their risk factors with the most recent clinic blood pressure and cholesterol measurements used for communication
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of random sequence generation not described
Allocation concealment (selection bias) Unclear risk No information was provided about how allocation was handled
Selective reporting (reporting bias) Low risk No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol
Other bias Low risk The study appears to be free of other sources of bias
Blinding of outcome assessment (detection bias) 
 Adherence measure High risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Blinding of outcome assessors not described. The study is an open‐label trial, however. This is a subjective measure
Blinding of outcome assessment (detection bias) 
 Patient outcome Unclear risk (PRIMARY) BLOOD PRESSURE ‐ it is unclear if a computerized method was used to take blood pressure
Blinding of participants (performance bias) 
 Adherence measure High risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Blinding of outcome assessors not described. The study is an open‐label trial, however. This is a subjective measure
Blinding of participants (performance bias) 
 Patient outcome Low risk (PRIMARY) BLOOD PRESSURE ‐ Outcome measurement not likely influenced by lack of blinding
Blinding of personnel (performance bias) 
 Adherence measure High risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Blinding of outcome assessors not described. The study is an open‐label trial, however. This is a subjective measure
Blinding of personnel (performance bias) 
 Patient outcome Unclear risk (PRIMARY) BLOOD PRESSURE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Incomplete outcome data (attrition bias) 
 Adherence measure Low risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No missing outcome data
Incomplete outcome data (attrition bias) 
 Patient outcome Low risk (PRIMARY) BLOOD PRESSURE ‐ No missing data