Margolius 2012.

Methods	Randomized controlled trial
Participants	The study location was the Family Health Center in San Francisco General Hospital, San Francisco, USA 129 participants were randomized to the intervention group and 108 participants were randomized to the control group The inclusion criteria were patients with blood pressures of at least 145 systolic or at least 90 diastolic mmHg, measured by the medical assistant at the enrollment visit and at least 1 previous visit in the last 12 months (based on chart review) The exclusion criteria were an age of younger than 30 years; not speaking English, Spanish, Cantonese, or Vietnamese; a creatinine level of greater than 1.5 mg/dl; New York Heart Association class III or IV heart failure; a life expectancy of less than 1 year; or being identified by one's primary care clinician as unable to follow instructions because of physical or cognitive disability, psychiatric illness, or other reasons
Interventions	Intervention: HOME TITRATION GROUP Clinicians of patients in the home‐titration arm completed an algorithm of antihypertensive medication adjustments. Health coaches made weekly telephone calls to participants in both study arms to discuss overall well‐being, adherence to action plans, and blood pressure values. Patients in the home‐titration arm who reported blood pressure greater than 140 mmHg systolic or greater than 90 mmHg diastolic and excellent medication adherence could choose to increase their antihypertensive medication regimen according to the algorithm without a clinician appointment. In those cases, health coaches notified a physician investigator to fax the prescription to the pharmacy. Clinicians were notified of medication changes by e‐mail, and health coaches entered the change in the electronic health record. The duration of the intervention was 6 months Control: NO HOME TITRATION Home monitoring and health coaching alone (no home‐titration arm), included health coaches made weekly telephone calls to participants in both study arms to discuss overall well‐being, adherence to action plans, and blood pressure values. The duration of the intervention was 6 months
Outcomes	The measures of adherence were self reported medication adherence. Health coaches recorded the number of days in the past week patient reported having missed taking a blood pressure medication. 6 months after study completion, patients' electronic health records were reviewed for the number of blood pressure medications at enrollment and at 6 months The patient outcomes were blood pressure and number of visits at primary care office. Systolic blood pressure was the primary outcome. Blood pressure was measured at baseline and 6 months. Patients were asked to come to the clinic, and blood pressure was measured by the medical assistant using the standard procedures: patients were seated at the nurse station for at least 5 minutes before blood pressures were measured with an automated machine on 1 arm. Electronic records were used to obtain information about the number of primary care visits made by each patient in the 6 month before, during and after the study.
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Unclear method of randomization ‐ (pg 200) "Study arm assignments were randomly ordered and enclosed in sealed, consecutively numbered envelopes. After enrollment, participants were assigned to one of the study arms by opening the next sealed envelope."
Allocation concealment (selection bias)	Low risk	Low bias method of allocation concealment ‐ (pg 200) "Study arm assignments were randomly ordered and enclosed in sealed, consecutively numbered envelopes. After enrollment, participants were assigned to one of the study arms by opening the next sealed envelope."
Selective reporting (reporting bias)	Unclear risk	In the protocol most outcomes other than adherence measure were mentioned (ref 20 ‐ Bennett H, Laird K, Margolius D, Ngo V, Thom DH, Bodenheimer T. BMC Public Health 2009;9:456‐61). The effectiveness of health coaching, home blood pressure monitoring, and home‐titration in controlling hypertension among low‐income patients: protocol for a randomized controlled trial
Other bias	High risk	The authors note the following limitations: the use of control, outcome measurement noted as limitations. (pg 204) "This study had several limitations. A usual‐care arm would have been helpful to further substantiate the improvement in SBP found in both intervention arms. In recent studies involving patients with elevated baseline SBP levels, however, levels dropped by 2, 6, 7, 10, 12, and 14 mm Hg with usual care, reductions considerably smaller than the approximately 20‐mm Hg SBP reduction in both groups of our study. In an effort to pattern our study intervention to standard clinical care, we used blood pressures measured by medical assistants at the office visit. This approach may have introduced more random error creating a bias toward not finding a difference between study arms. It is unlikely that it affected the result to the point of masking a true significant difference, however. The potential impact on the before‐after analysis would be toward the null hypothesis, making our results a conservative estimate of actual change from baseline to 6 months. The association between number of coaching encounters and SBP reduction, while supportive of a true effect of health coaching, relied on observational data and could reflect confounding by unmeasured variables. Although we expected health coaching to improve medication adherence, self reported adherence decreased over the course of the study. Two factors may explain this seemingly paradoxic finding. First, on the basis of coaches' reports, many patients at baseline did not know their medications well enough to accurately report adherence. Second, patients may have become more truthful as they developed trusting relationships with their coaches. Also, self reported adherence correlates poorly with more objective adherence measures."
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ The outcome was self reported by the participants. The outcome was not likely to be affected by the lack of blinding of data collectors
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) BLOOD PRESSURE ‐ No mention of blinding of outcome assessors but objective outcome ‐ "...blood pressures were measured with an automated machine on 1 arm."
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Subjective outcome; no mention of blinding of patients
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) BLOOD PRESSURE ‐ No mention of blinding but objective outcome ‐ "...blood pressures were measured with an automated machine on 1 arm."
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No mention of blinding or of role of other study personnel in outcome assessment
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) BLOOD PRESSURE ‐ No mention of blinding of outcome assessors but objective outcome ‐ "...blood pressures were measured with an automated machine on 1 arm."
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ There were no significant differences in attrition rates between the 2 groups. Patients who dropped out or were lost to follow‐up did not differ significantly from patients who completed the study
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) BLOOD PRESSURE ‐ There were no significant differences in attrition rates between the 2 groups. Patients who dropped out or were lost to follow‐up did not differ significantly from patients who completed the study