WHO 1983.
Study characteristics | ||
Methods |
Study design: Multicentre RCT (24 sites; 12 centres accepted for meta analysis.) Country: Multiple European countries Dates participants recruited: 1972 to 1974 Maximum follow‐up: 3 years Participants randomised on discharge from hospital. |
|
Participants |
Inclusion criteria: Men < 65 years with first or consecutive MI. Exclusion criteria: NR N randomised: total: 3184; intervention: 1655; comparator: 1529 Diagnosis (% of participants): MI: 100% Age (years): intervention: 52.3; comparator:53.5 Percentage male: intervention: 100%; comparator: 100% Ethnicity: NR |
|
Interventions |
Intervention: Comprehensive programme dependent on local provision. Physical training was not compulsory but was strongly recommended. Components: exercise, education and psychosocial support. Setting: centre. Exercise programme modality: NR Length of session: NR Frequency: NR Intensity: NR Resistance training included? NR Total duration: 6 weeks. Co‐interventions: The intervention had to be at the highest possible level available locally. It had to be comprehensive, with the aim of improving health and reducing IHD risk. It comprised treatment of heath failure, arterial hypertension etc, risk factor modification, weight loss and improving physical working capacity. Comparator: usual care. Co‐interventions: none described. |
|
Outcomes | Total mortality, CVD, CHD & sudden death. Fatal & non‐fatal re‐infarction. | |
Source of funding | WHO Regional Office for Europe and the Ministries of Health of the participating member states. | |
Conflicts of interest | ||
Notes | Methodological problems with the execution of the study allowed only death and re‐infarction to be successfully used as end points. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "Patients were randomised at admission.....by means of random number tables". However, only "12 centres out of the 24 seemed to have achieved proper randomisation in their groups of R and C patients” |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No description of withdrawals or dropouts. Varied greatly from site to site. |
Selective reporting (reporting bias) | Low risk | All clinical endpoints were reported for 12, 24 and 36 month follow‐ups. |