Wu 2012.

Methods	Randomized controlled trial
Participants	The study location was a southern state, USA 27 participants were randomized to the theory‐based intervention plus MEMS (PLUS) group, 27 participants were randomized to the theory‐based intervention only (LITE) group and 28 participants were randomized to the control group The inclusion criteria were 1) having a diagnosis of chronic heart failure (HF); 2) undergoing evaluation of HF by a cardiologist and optimization of medical therapy; and 3) being able to read and speak English The exclusion criteria were 1) impaired cognition; 2) a coexisting imminently terminal illness such as cancer or chronic renal failure requiring dialysis; 3) a myocardial infarction within the past 3 months; or 4) a history of cerebral vascular accident within the past 3 months or with major sequelae
Interventions	Intervention: LITE The intervention was delivered by a cardiovascular nurse expert in delivery of the education and counseling intervention. Patients received the counseling intervention individually every other week for a total of 4 sessions. The first and third sessions were face‐to‐face education and counseling lasting 1 hour. The second and 4th sessions were delivered by telephone and lasted 20 minutes each. The intervention was designed to influence medication adherence by creating a more positive attitude toward medication adherence, incorporating significant others into the patient education and counseling sessions to build a positive subjective norm, and providing needed information and skills to overcome barriers to adherence to increase the patient's perceived behavioral control Intervention: PLUS In addition to what was received by the LITE group, participants received feedback on their medication taking behavior from the MEMS at each of the 2 face‐to‐face sessions. MEMS feedback was used to show the patients their own medication taking behavior and identify problematic areas. A visual display was shared by the nurse with the participant Control: USUAL CARE Received usual care. Participants completed a baseline survey, were contacted monthly to collect outcome, and completed a 9‐month questionnaire. In addition their MEMS data were downloaded at 1, 2, and 9 months
Outcomes	The adherence measure was MEMS, used to collect information on one heart failure medication. Patients were given a diary to record unscheduled cap openings, such as those to refill the bottle, and those unscheduled events unrelated to adherence were removed from analysis. Participants were given the bottles at the start of the study by a trained nurse, including written and verbal instructions on how to use it. After 1 month, a research nurse downloaded the MEMS data. Patients used the bottle during the study and returned it at 9 months The patient outcomes were cardiac event‐free survival and quality of life. Cardiac event‐free survival was the composite endpoint. This endpoint consisted of cardiac‐related emergency department (ED) visit, cardiac‐related hospitalization, or cardiac death. Monthly follow‐up phone calls to patients collected these data, with confirmation via hospital records. Date and cause of death were collected from interviews with family members and physicians and confirmed by review of medical records and death certificates. Quality of life was measured using the Minnesota Living with Heart Failure Questionnaire (LHFQ). It consists of 21 questions rated on a scale from 0 (no effect) to 5 (very much). Item ratings are summed for a total score that can range from 0 to 105. Higher scores reflect worse quality of life. Questions concern a variety of physical and psychologic aspects of living with HF and include activities of daily living, economic issues, ability to work, enjoyment of leisure time activities, relations with family and friends, sexual activity, side effects from medications, depression, and impact of HF symptoms
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomization was not described in detail. "This study was a randomized controlled trial to determine the effect of a theory‐based intervention on medication adherence and cardiac event‐free survival in patients with HF. All patients were randomly assigned to theory‐based intervention plus feedback of medication‐taking behavior from the MEMS (the PLUS group), theory‐based intervention only (LITE), or usual care (control)." (pg 2)
Allocation concealment (selection bias)	Unclear risk	No information was provided about how allocation was handled
Selective reporting (reporting bias)	Unclear 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 seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ MEMS is an objective measure of adherence
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) CARDIAC EVENT‐FREE SURVIVAL ‐ Objective data; unlikely to be biased. Patients were followed monthly by phone to obtain their hospitalization data by a research associate blind to group assignment from baseline to the end of the study
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) MEMS ‐ Although MEMS is an objective measure of adherence, it does not indicate if patients were blind to study purpose. Patients were asked to record unscheduled cap openings
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) CARDIAC EVENT‐FREE SURVIVAL ‐ Participants were not blinded to the study but information was collected from the patients were confirmed with medical records and death certificates
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) MEMS ‐ No details on blinding are given, and the authors indicate that adjustments were made to the MEMS data based on patient self report record. Patients were given a MEMS diary to record unscheduled cap openings, such as those to refill the bottle, so that those unscheduled events unrelated to adherence were removed from analysis
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) CARDIAC EVENT‐FREE SURVIVAL ‐ Insufficient information about blinding to permit judgment of 'Low risk' or 'High risk'
Incomplete outcome data (attrition bias) Adherence measure	Unclear risk	(PRIMARY) MEMS ‐ There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) CARDIAC EVENT‐FREE SURVIVAL ‐ Insufficient reporting of attrition/exclusions to permit judgment of 'Low risk' or 'High risk'