Kanyini GAP 2014.

Methods	"randomized, open‐label trial"
Participants	623 participants (311 polypill, 312 comparator) from 33 centres (12 Aboriginal Medical Services); target = 1000 participants in Australia Mean (SD) age: 63.4 (12.5) years intervention; 63.7 (12.7) years comparator Women: 37% intervention; 37% comparator Indigenous: 51% overall (not reported by group) CVD: 59% intervention; 63% comparator CHD: 52% intervention; 54% comparator CM: 60% intervention; 55% comparator Inclusion criteria: "18 years or over and able to give informed consent, have a history of coronary heart disease (myocardial infarction, stable or unstable angina pectoris, or coronary revascularization procedure), and/ or ischaemic cerebrovascular disease, and/or peripheral vascular disease; or a calculated 5‐year CVD risk of 15% or greater*...Each participant had to have, in their doctor’s view, indications for all and no contraindications to any component of at least one of two polypills" *including a 5% increment for Aboriginal or Torres Strait Islander identification Exclusion criteria: “Participants were excluded if it was felt clinically inappropriate to alter medications.”
Interventions	Intervention Aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg, atenolol 50 mg Aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg Comparator: "usual care" "Out‐of‐pocket expenses for the polypill were incurred identically to those for any other drug listed in the Pharmaceutical Benefits Scheme, which is the government subsidy programme through which most drugs are obtained in Australia."
Outcomes	Primary Self‐reported use of all medications was assessed at each visit, recorded as the number of days on which medication was taken in the immediately preceding week… antiplatelet, statin and >2 BP lowering therapies for >4 of the previous seven days)” Blood pressure (SBP, DBP) Lipids (total cholesterol, LDL cholesterol) Secondary Barriers to adherence Health‐related quality of life (EQ‐5D questionnaire) Cardiovascular, renal and other serious adverse events Reasons for stopping cardiovascular medications Time points measured: baseline, 1 month, and q6 month through 24 months Follow‐up: intervention: median 20.7 months, comparator: median 18.1 months
Notes	Comparator: usual care
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Central, computer‐based randomization to polypill‐based strategy or usual care was stratified by primary healthcare centre, type of indication (established CVD versus high risk), Indigenous identification and level of preventive treatment at baseline.”
Allocation concealment (selection bias)	Low risk	“Central, computer‐based randomization to polypill‐based strategy or usual care was stratified by primary healthcare centre, type of indication (established CVD versus high risk), Indigenous identification and level of preventive treatment at baseline.”
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open label trial
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Adherence: high risk of bias because it was self reported SBP/TC/events: low risk of bias because these are objective measures, and the latter was adjudicated by a blinded outcome assessment committee
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low rates of losses to follow‐up and missingness, with rates balanced between the groups
Selective reporting (reporting bias)	Low risk	No differences between primary reports and protocol
Other bias	Unclear risk	Small study bias for events but low risk of bias for adherence and change in risk factors