| Methods |
319 patients were randomized by the researchers after giving informed consent. 165 patients were in the mentoring group and 154 in the control group. Eligible patients were stratified by sex, disease modality (myocardial infarction or angina), and location (5 areas identified) |
| Participants |
Patients aged 60 or over that had been either admitted to hospital, or had attended the outpatient department, with a clinical diagnosis of ischemic heart disease (IHD). Exclusion criteria were terminal illness, an abbreviated mental health test score < 8, inability to complete 3 minutes of Bruce Protocol exercise tolerance testing, awaiting angioplasty or coronary artery bypass grafting, participation in another clinical study involving coronary risk factor modification or at the request of their consultant or general practitioner |
| Interventions |
Intervention consisted of participation in a mentor‐led group, through attending monthly 2‐hour‐long meetings in community facilities over a 1‐year period. There was an average of 10 patients per group, each led by 2 mentors. Both intervention and control groups continued to receive standard care. The core activities covered in the program were lifestyle risk factors of smoking, diet and exercise; blood pressure and cholesterol; understanding of and ability to cope with IHD; and drug concordance. Each mentored group was also encouraged to develop its own agenda. Input was provided from a pharmacist, cardiac rehabilitation specialist nurse, dietician, welfare benefits advisor, and Recreation Services. Volunteer lay health mentors, aged 54 to 74 recruited from the local community, led the groups |
| Outcomes |
Perceived change in taking of medication was measured using a 5‐point Likert scale in the exit questionnaire. Outcome measures were changes in blood pressure, cholesterol and medication, and cardiovascular events; non‐medical support requirement, health status and psychological functioning, and social inclusion |
| Notes |
This is self reported concordance and there was no attempt to standardize the regimens, so this may be explained by differences in medications, insensitive/biased measure of adherence, or low power |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomization was done appropriately. (pg 350) "Patients were randomised by the researchers after giving informed consent. Eligible patients were stratified by sex, disease modality (myocardial infarction or angina) and location (five areas identified). They were allocated using computer‐generated sealed envelopes supplied by the University of Edinburgh Medical Statistics Unit." |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment via sealed envelopes but unclear if opaque or ordered. (pg 350) "...They were allocated using computer‐generated sealed envelopes supplied by the University of Edinburgh Medical Statistics Unit." |
| Selective reporting (reporting bias) |
Unclear risk |
No reporting bias detected but protocol not available |
| Other bias |
High risk |
Some major limitations were noted in discussion. (pg 353) "We recognise limitations of our study due to potential referral bias introduced by focussing on fitter individuals who could complete exercise testing. The inclusion of food and physical activity diaries was open to recall bias but changes were biologically consistent in a beneficial direction. The widespread community interest in this study and subsequent increased awareness of risk factors for coronary heart disease may have diluted the effect of mentoring. Our study was not sufficiently powered to elicit differences in clinical events and mortality. We also recognise that a small number of our significant results may be explained by multiple testing." |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Outcome assessors were blinded. (pg 349) "Exit evaluation was blinded." |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) HEALTH QUESTIONNAIRES ‐ (pg 349) "Exit assessments were by blinded staff". Health status and food data were collected separately; no mention about blinding |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No mention of patient blinding and interviews are subjective. Likely high risk due to the nature of the intervention |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) HEALTH QUESTIONNAIRES ‐ Likely high risk due to the nature of the intervention. No mention of blinding of patients and subjective interviews |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No mention of study personnel blinding |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) HEALTH QUESTIONNAIRES ‐ No mention of blinding of other study personnel |
| Incomplete outcome data (attrition bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Balanced dropouts and reasons provided |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) HEALTH QUESTIONNAIRES ‐ Low rate of completion for food diary but likely to be low bias for other outcomes in the questionnaire list |
