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. 2019 Mar 14;2019(3):CD010748. doi: 10.1002/14651858.CD010748.pub2

WHO 1983.

Methods Study design: multi‐centre, RCT
Recruitment: 24 centres; hospitalised AMI patients from June 1973‐October 1975
Allocation: not reported
Blinding: not reported
Randomisation: random numbers table (some centres applied cluster‐randomisation or a non‐randomised control group)
Follow‐up(s): 3, 6, 12 months, 2 and 3 years
Description: combined rehabilitation programme
Participants Baseline characteristics
Intervention group (rehabilitation)
  • Age (%): 38% < 50 years; 41% 50‐59 years; 21% 60‐65 years

  • Sex (male %): 100

  • Number of participants randomised: 1655

  • Working before CHD: ‐


Control group
  • Mean age (SD): 34% < 50 years; 39% 50‐59 years; 28% 60‐65 years

  • Sex (male %): 100

  • Number of participants randomised: 1529

  • Working before CHD: ‐


Inclusion criteria
  • Diagnosed with AMI and treated in hospital

  • Male

  • Aged < 66 at AMI


Exclusion criteria
Baseline imbalances:
Physically demanding work: unknown
Severity of CHD: severe
Interventions Intervention characteristics
  • Each centre developed their own combined rehabilitation programme. The programmes' goals were to improve health by addressing the following.

    • Treatment of underlying conditions and relevant co‐morbidities (e.g. heart failure, diabetes, etc.)

    • Risk factors (e.g. weight and serum lipid level reduction, smoking cessation, reduction of alcohol consumption, etc)

    • Increase physical working capacity

    • "Psychological, social and vocational sequelae of AMI had to be identified and corrected as far as possible"

    • Physical training (optional)

  • Duration of intervention: ‐

  • Providers: ‐


Control group
  • Usual care according to the region of the centre

Outcomes Proportion at work at < 6 months (short term): 3 months
Proportion at work at 6–12 months (medium term): 12 months
Proportion at work at > 12 months to < 5 years (long term): 3 years
Adverse events (mortality, reinfarctions, non‐fatal reinfarctions)
Identification Sponsorship source: WHO
Country: international
Setting:
Possible conflicts of interest: no information provided
Ethics committee approval: not reported
Notes The results of the individual centres were often published separately and the number of people included in the RTW results were not reported, therefore this study is not included in the meta‐analyses.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Although the study protocol called for the randomisation of participants according to random number tables, some study centres applied cluster‐randomisation or a selected a non‐randomised control group (i.e. control hospital). Also the study authors write, "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 None described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Due to the nature of the study, blinding of participants was not possible.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk None described
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "By 1 April 1970 data on follow‐up over a three‐year period were available for about 78% of all patients initially enrolled in the study."
Overall 22% loss to follow‐up
Selective reporting (reporting bias) Low risk All of the results' proposed analyses seem to have been reported.
Other bias Unclear risk None identified