Guthrie 2001.

Study characteristics
Methods	Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Equivalence design: 2‐sided confidence interval Open‐label
Participants	N recruited = 13,100 N randomised = 13,100 (2765 control, 10335 intervention) N reported outcomes = 4548 (3635 in intervention group, 913 in control group) ‐ returned 6‐month patient survey forms Mean age 57.9 years (intervention group), 58.3 years (control group) INCLUSION CRITERIA "Patients with risk scores ~4 on a scale of ‐1 to +16 for men and ‐1 to +17 for women on the First Heart Attack Risk Test were considered to be at increased risk for a first MI and suitable for enrollment in the registry program. An elevated total cholesterol level despite dietary interventions was an additional inclusion criterion." EXCLUSION CRITERIA "Previous MI, current therapy with a 3‐hydroxy‐3‐methylglutaryl coenzyme A reductase inhibitor (i.e., statin), as well as membership in a federally funded health care program (except Medicare or plans for federal employees) constituted exclusion criteria. Medicaid patients were excluded in accordance with federal regulations prohibiting participation of such patients in programs involving prescription writing. Women of childbearing potential were similarly excluded from participation in the registry." COUNTRY/SETTING: USA STUDY PERIOD: December 1997 to December 1998
Interventions	Number of study centres: 2708 physicians INTERVENTION GROUP "Individuals randomized to the intervention group received telephone reminders at weeks 2 and 8, as well as reminder postcards at week 4, to reinforce these messages about coronary risk reduction. Each of these communications stressed the importance of following the physician’s instructions and taking medications as prescribed. These reminders were issued by a national program‐coordinating center. Reminder postcards were also mailed to both groups at 4 and 5 months after enrollment. Physicians completed follow‐up evaluation forms after patient visits, which were scheduled according to their normal practices." CONTROL GROUP Usual care
Outcomes	TIME OF OUTCOME MEASUREMENTS "At 3 and 6 months or study discontinuation, registry participants completed patient‐survey forms concerning compliance with care and mailed these to the program‐coordinating center." PRIMARY OUTCOME: compliance SECONDARY OUTCOME: lifestyle modifications
Notes	Commercial funding/non‐commercial funding/other funding: "This registry was funded by Bristol‐Myers Squibb Co, Princeton, New Jersey." "For professional services and administrative activities conducted in association with the First MI Risk Reduction Program, each participating physician received an honorarium of $500 from the registry sponsor." Stated aim for study: "The purpose of the First Myocardial Infarction (MI) Risk Reduction Program, an open‐label drug registry involving mainly primary‐care patients at increased risk of a first MI, was to examine the effects of postal and telephone reminders, as well as demographic and other baseline characteristics, on patient self‐reported compliance with pravastatin treatment."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Unblinded "open‐label" study
Incomplete outcome data (attrition bias) All outcomes	High risk	"‐35% of the total number of patients enrolled who returned patient survey forms to the national program coordinating center at 6 months"
Selective reporting (reporting bias)	Low risk	All outcomes reported