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.” |
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Interventions | Intervention
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." |
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Outcomes | Primary
Secondary
Time points measured: baseline, 1 month, and q6 month through 24 months Follow‐up: intervention: median 20.7 months, comparator: median 18.1 months |
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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 |