Ogedegbe 2012.

Methods	Randomized controlled trial
Participants	The study location was a primary care practice within the ambulatory care network of New York Presbyterian Hospital, New York, New York, USA 125 participants were randomized to the intervention group and 131 participants were randomized to the control group The inclusion criteria were self identification as African American or black, fluency in the English language, a diagnosis of hypertension, and the use of at least 1 antihypertensive medication The exclusion criteria were (i) had a diagnosis of cognitive impairment or serious medical condition as determined by their primary care physician, (ii) were unable to provide informed consent, or (iii) refused to participate
Interventions	Intervention: POSITIVE AFFECT INTERVENTION Patients in the Positive Education (PE) control group received a culturally tailored educational workbook designed (1) to enhance patients' knowledge about hypertension, (2) to improve self management behaviors, and (3) to support goal‐setting. Patients randomized to the Positive Affect (PA) intervention group were given the same workbook as those in the PE group but with an additional chapter that addresses the benefits of positive moments in overcoming obstacles to medication adherence. Also, these patients received 2 forms of PA during bimonthly telephone calls. First, they were asked to identify small things in their lives that invoke positive feelings in them and were then instructed to incorporate these positive thoughts into their daily routine. The positive thoughts were further reinforced during subsequent bimonthly telephone calls. Second, the patients received unexpected small gifts mailed to them before each telephone call. This strategy was based on the potential of the receipt of unexpected gifts to induce positive feelings. For self affirmation induction, the patients were asked to remember their core values and proud moments in their lives whenever they encounter situations that make it difficult for them to take their medications Control: PATIENT EDUCATION Patient Education (PE) control group received a culturally tailored educational workbook designed (1) to enhance patients' knowledge about hypertension, (2) to improve self management behaviors, and (3) to support goal‐setting. On receipt of the workbook, trained Research Assistants (RAs) reviewed each chapter with the patients and then asked them to sign a behavioral contract that asked them to make a commitment to taking their medications as prescribed. Subsequent to this session, each patient received bimonthly telephone calls, during which the RAs assessed the patient's behavioral contract and confidence to take their medications as prescribed. These assessments served as the basis for reviewing and counseling the patient on perceived barriers to medication adherence. The intervention lasted for 12 months
Outcomes	The measures of adherence were self report questionnaire for baseline adherence measurement and an electronic pill monitor. Patients taking more than 1 medication could select the medication they wanted to put in the monitor. Monitors were returned to research assistants to have data downloaded or were sent in for downloading at 12 months. Electronic pill monitors are the accepted gold standard for adherence assessment The patient outcomes were change in blood pressure (BP) from baseline to 12 months. BP data were extracted from patients' electronic medical records log of office BP readings taken by nurses or certified medical assistants using standard mercury sphygmomanometers. Blood pressure control was defined as a BP greater than 130/80 mm Hg for patients with diabetes or chronic kidney disease and a BP less than 140/90 mm Hg for all other patients
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Used a computer random‐number generator. "Separate randomization schedules were developed from a computerized random‐number generator, balanced at set intervals, using permutated blocks in order to assure equal numbers in each arm. Randomization assignment was carried out by the study statistician using sealed envelopes. Upon randomization, each patient was entered into the study and included in the intention‐to‐treat analysis. A total of 95 patients were randomly assigned to each study group. As is typical for most behavioral interventions, neither the patient nor the RA delivering the motivational interviewing could be blinded to the intervention assignment. However, the primary‐care physician did not know the randomization group to which his or her patient belonged." (pg 172s)
Allocation concealment (selection bias)	Unclear risk	There is no mention of sequential allocation but opaque and sealed envelopes used. "On completion of the baseline assessments, the study biostatistician randomly assigned patients to either the PE control group or the PA intervention group in a 1:1 ratio. Patient assignments were placed in sealed opaque envelopes. As is typical for most behavioral interventions, neither the patients nor the RAs were blinded to the intervention. The primary care providers did not know their patients' group assignment." (pg 323)
Selective reporting (reporting bias)	Low risk	The same measures were noted in the protocol. "Study measures included the Morisky self‐report medication adherence questionnaire, the CES‐D measure of depression, the Duke Social Support and Stress Scale (DUSOCS), the Charlson comorbidity index, the medication adherence self‐efficacy scale (MASES), and the Treatment Self‐Regulation questionnaire (TSRQ) measure of intrinsic motivation." (pg 173)
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) ELECTRONIC PILL MONITOR ‐ This is an objective measure of outcome
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) BLOOD PRESSURE MEASUREMENT ‐ "The primary care providers did not know their patients' group assignments." (pg 323)
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) ELECTRONIC PILL MONITOR ‐ No patient blinding but blinding may have been broken due to the nature of the intervention
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) BLOOD PRESSURE MEASUREMENT ‐ The lack of blinding is not likely to affect the outcome. Information is also taken from patient records
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) ELECTRONIC PILL MONITOR ‐ This is an objective measure of outcome
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) BLOOD PRESSURE MEASUREMENT ‐ 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) ELECTRONIC PILL MONITOR ‐ After randomization, 2 withdrew, 7 were unavailable to follow‐up, and 3 died from the positive affect group, therefore 113 completed the trial from the intervention group. From the control group, 11 withdrew, and 5 were unavailable for follow‐up. 115 completed the trial at 12 months from the control group. Refer to Figure, CONSORT diagram. Approximately same number of missing information is there from both groups and the follow‐up at 12 months is greater than 80%
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) BLOOD PRESSURE MEASUREMENT ‐ After randomization, 2 withdrew, 7 were unavailable to follow‐up, and 3 died from the positive affect group, therefore 113 completed the trial from the intervention group. From the control group, 11 withdrew, and 5 were unavailable for follow‐up. 115 completed the trial at 12 months from the control group. Refer to Figure, CONSORT diagram. Approximately same number of missing information is there from both groups and the follow‐up at 12 months is greater than 80%