Sherrard 2009.

Methods	Randomized controlled trial
Participants	The study location was University of Ottawa Heart Institute (UOHI), Ontario, Canada 164 participants were randomized to the intervention group and 167 participants were randomized to the control group The inclusion criteria were over the age of 18, discharged from the UOHI, underwent coronary artery bypass grafts and/or valvular surgery, had telephone service to their home, and spoke either English or French The exclusion criteria were: underwent other surgeries such as cardiac transplantation and/or they were discharged to a care facility or other institution
Interventions	Intervention: INTERACTIVE VOICE RESPONSE (IVR) Patients in the IVR follow‐up group received automated telephone calls for 6 months, at 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 weeks after discharge. The telephone interview contained an algorithm of 11 questions addressing medication compliance, reporting of adverse events, providing information on common medications, and offering general medication safety tips. The intent of the IVR algorithm was to provide early identification of issues permitting timely intervention, provide a mechanism for tracking medication compliance, and provide medication information at the time deemed most valuable by the patient at his or her request and to provide longer term follow‐up as the patient transitioned from hospital to home. Patients were asked questions about medication compliance such as, "Did you fill the prescriptions given to you at discharge?" and were offered additional information on 8 common medications prescribed to cardiac surgical patients on discharge. The answers to the questions were captured in a database. Depending on the response, a colored flag appears in the database next to the question indicating no action is needed, the call was not answered, or alerting the nurse to intervene by calling the patient to provide education and counseling Control: USUAL CARE Patients in the control group received the standard of care provided to all patients discharged from post‐cardiac surgery. This included receiving an IVR call on day 3 and 10 after discharge to screen common symptoms. This current surgical follow‐up algorithm does not contain questions or information on medications. They were contacted at 6 months to answer questions on medication compliance and outcomes
Outcomes	The measure of adherence was contacting of patients at 6 months via telephone to answer questions on medication compliance The patient outcomes were hospitalizations and emergency room visits, assessed via questionnaire during IVR follow‐up
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomization was not described in detail. "Allocation to the treatment group was blinded by using a sealed envelope identified by study number and containing the random allocation. Randomization occurred once consent to participate was obtained." (pg 11)
Allocation concealment (selection bias)	Unclear risk	Allocation concealed through use of sealed envelopes but there is no mention of opaque envelopes. "Allocation to the treatment group was blinded by using a sealed envelope identified by study number and containing the random allocation. Randomization occurred once consent to participate was obtained." (pg 11)
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	Unclear risk	There are limitations to this study. "The six month surveys were conducted by telephone interview by the research nurse coordinator who had intervened with the patients during the study. The lack of anonymity may have caused a favorable response bias. Recall was required for questions on emergency visits and hospitalization. The interview schedule was not pre‐tested. Close‐ended, forced choice dichotomous questions limited the potential responses of the patients." (pg 15)
Blinding of outcome assessment (detection bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ "The six‐month surveys were conducted by telephone interview by the research nurse coordinator who had intervened with the patients during the study" (pg 15)
Blinding of outcome assessment (detection bias) Patient outcome	High risk	(PRIMARY) COMPOSITE OUTCOME (HOSPITALIZATIONS, ER VISITS) ‐ "The six‐month surveys were conducted by telephone interview by the research nurse coordinator who had intervened with the patients during the study."
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding
Blinding of participants (performance bias) Patient outcome	Unclear risk	(PRIMARY) COMPOSITE OUTCOME (HOSPITALIZATIONS, ER VISITS) ‐ No mention of patient blinding; it is unclear if blinding might impact outcome reporting
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) COMPOSITE OUTCOME (HOSPITALIZATIONS, ER VISITS) ‐ 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	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ The survey response rates were 84% and 86% for the IVR and UC group respectively. The response rate is balanced across both groups but not reasons given for missing data
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) COMPOSITE OUTCOME (HOSPITALIZATIONS, ER VISITS) ‐ The survey response rates were 84% and 86% for the IVR and UC group respectively. The numbers are balanced across the groups but no reason for missing data is given