Faulkner 2000.

Methods	DETAILS OF STUDY AIM OF INTERVENTION: To enhance compliance and improve outcomes. AIM OF STUDY: To evaluate the impact of personalized telephone follow‐up on compliance rates in high‐risk hypercholesteraemic patients receiving combination drug therapy. STUDY DESIGN: RCT. METHODS OF RECRUITMENT OF PARTICIPANTS: During a 7 month period patients who had undergone CABG surgery or percutaneous transluminal coronary angioplasty were eligible; patients were recruited from the coronary care unit. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: CABG or PTCA patients/ baseline fasting LDL above 130 mg/dl/ able to read, understand and speak English/ have telephone at home EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: serum transaminase level twice above normal/concomitant therapy with cyclosporine, warfarin or erythromycin/history of gastrointestinal disease. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? unclear. FUNDING: unclear. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: unclear. EPOC‐ QUALITY CRITERIA 2002: C. high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: a computer generated list of random numbers. METHOD OF CONCEALMENT OF ALLOCATION: unclear. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: no. INTENTION TO TREAT ANALYSIS: not stated. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: yes. STATISTICAL METHODS AND THEIR APPROPRIATENESS: chi‐square/t‐test. CONSUMER INVOLVEMENT: not stated.
Participants	DESCRIPTION : surgery patients / cardiac patients. GEOGRAPHIC LOCATION: USA. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 30. RANDOMISED TO INTERVENTION: 15. RANDOMISED TO CONTROL: 15. INCLUDED IN ANALYSIS INTERVENTION GROUP: 15. INCLUDED IN ANALYSIS CONTROL GROUP: 15. AGE: RANGE OR MEAN (SD): 62.5 (12). GENDER (% MALE): 57. ETHNICITY: 70% Caucasian. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: cardiovascular disease. OTHER HEALTH PROBLEM/S: hypercholesterolaemia. TREATMENT RECEIVED/RECEIVING: CABG (20x)/PTCA(10). OTHER SOCIAL/DEMOGRAPHIC DETAILS:
Interventions	DETAILS OF INTERVENTION: A pharmacist telephoned patients at their home every week for 12 weeks. To ensure consistency, the same pharmacist was involved in each patient contact and a standard set of questions was asked. Emphasis was placed on the importance of therapy in reducing the risk of recurrent cardiac events. Patients were questioned about when and where prescriptions were filled, how they paid their prescriptions, potential side‐effects, overall well‐being, and specific reasons for non‐compliance when applicable. DETAILS OF CONTROL: usual care. CO‐INTERVENTION? yes. DETAILS OF CO‐INTERVENTIONS: in hospital all patients were extensively counseled on the appropriate use of the drugs and all patients received dietary instructions. DELIVERY OF INTERVENTION Frequency: 12. First time at day 7 after discharge. Period: 12 weeks. PROVIDERS: pharmacist. INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: unclear.
Outcomes	NUMBER OF OUTCOMES: 2 OUTCOME / TOOL / TOOL VALIDATED / METHOD OF ASSESSMENT / TIME OF ASSESSMENT A.Psycho‐social health of patients (uncertainty, anxiety, informational needs, mood, coping, quality of life, social activity, ..): B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): C.Other consumer oriented outcomes (e.g. treatment adherence, knowledge, adverse events, ..): Compliance / pill count / no / pill count at the clinic visit / 6 and 12 weeks after discharge and at 1 and 2 years. Lipid‐profiles / blood sample / unclear / blood analysis / 6 and 12 weeks after discharge. D. Health service delivery oriented outcomes (e.g. hospital readmission, health services utilization, ..):
Notes	·CHANGES IN TRIAL PROTOCOL NB: for the review only outcomes at 6 and 12 weeks were analyzed ·CONTACT WITH AUTHOR ·POWER CALCULATION? yes. ·RECORD IF THE STUDY WAS TRANSLATED FROM A LANGUAGE OTHER THAN English. ·RECORD IF THE STUDY WAS A DUPLICATE PUBLICATION.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear