Muniz 2010.

Methods	Randomized controlled trial
Participants	The study location was 64 hospitals throughout Spain 867 participants were randomized to the intervention group and 890 participants were randomized to the control group The inclusion criteria were male and female patients admitted for acute coronary syndrome with or without ST‐segment elevation, discharged with a diagnosis of Q‐wave or non‐Q‐wave acute myocardial infarction (AMI) or unstable angina with sufficient cultural level to be able to understand the intervention and the ability to fulfill the schedule of proposed further visits (at 2 and 6 months) The exclusion criteria were under 18 or above 80 years of age, those presenting accompanying illnesses which would cause unfavorable prognosis in the following months or which would prevent their participation
Interventions	Intervention: POST DISCHARGE EDUCATIONAL INTERVENTION Intervention is an educational intervention consisting of a signed agreement between patient and physician on the objectives to be reached. The intervention includes a personalized interview at discharge with patient and nearest next‐of‐kin, in which physician and patient discuss and sign an agreement with the patient‐specific secondary prevention procedures and therapeutic aims. Both physician and patient keep a copy of the signed agreement. Written back‐up information (about heart attack, controlling cholesterol, body weight, and blood pressure, and effects of smoking) and a phone number as to where to call in case of questions were given. Intervention also included an interview with the patient 2 months after discharge in order to review the agreement, adapt treatment if needed and reinforce the intervention. Informative materials are given once again.The visits took an average of 30 to 40 minutes each Control: USUAL CARE Control group participants received usual care. Follow‐up was at 6 months
Outcomes	The measures of adherence were self report at baseline and at 6 months The patient outcomes were blood pressure, BMI, and lipid levels measured at baseline and 6 months. Lipid levels were sourced from hospital data
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"1,757 patients were assigned to the Intervention Group (n = 867) or the Control Group (n = 890) by means of stratified randomization by centre and with concealment of allocation sequence. The unit of randomization was the patient and the stratification by centre was done to remove the effect of the hospital by obtaining groups of equal size (intervention and control) in every hospital." (pg 2)
Allocation concealment (selection bias)	Low risk	The author notes that very center had a sequence prepared for 30 patients. Every sequence was hospital‐specific and randomly ordered
Selective reporting (reporting bias)	Low risk	The author has provided the protocol
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ This is a subjective measure; there is no information on blinding. This is an open‐label study
Blinding of outcome assessment (detection bias) Patient outcome	Unclear risk	(PRIMARY) BLOOD PRESSURE ‐ This is an open‐label study. No information on whether the method of taking blood pressure was computerized. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ The study was open‐labeled. This is a subjective measure of adherence
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) BLOOD PRESSURE ‐ Although this is an open‐label study, the outcome is objective. Therefore lack of blinding is not likely to affect the outcome
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ The author notes that there were no "key study personnel" who might have affected data quality
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 ‐ INTERVIEW ‐ The author notes that the absolute proportion of those who refused to come to the final visit is equal in the 2 groups (4%) (figure 1)
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) BLOOD PRESSURE ‐ The author notes that the absolute proportion of those who refused to come to the final visit is equal in the 2 groups (4%) (figure 1)