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

Rahe 1979.

Methods Study design: parallel RCT
Recruitment: October 1971‐June 1972 (January‐July1973 17 additional post‐MI patients were referred for treatment)
Allocation: not reported
Blinding: not reported
Randomisation: no method described
Follow‐up(s): 18 months, 3‐4 years
Description: a randomised treatment group and a non‐randomised group of volunteers (not included in the meta‐analysis) received group therapy
Participants Baseline characteristics
Intervention group 1 (randomised)
  • Mean age (SD): 50.9

  • Sex (male %): 85

  • Number of participants randomised: 22

  • Working before CHD: 17


Intervention group 2 (non‐randomised volunteers, not included in the analysis)
  • Mean age (SD): 51.5

  • Sex (male %): 100

  • Number of participants: 17

  • Working before CHD: 13


Control group (CG)
  • Mean age (SD): 55.2

  • Sex (male %): 94

  • Number of participants randomised: 22

  • Working before CHD: 12


Inclusion criteria
  • MI survivors

  • First MI (unequivocally documented)

  • < 60 years

  • Patients eligible to return to work

  • Resided in the San Diego area and planned to remain there for at least 3 years


Exclusion criteria: not reported
Baseline imbalances: average age: intervention group 1 50.9 years; control group 55.2 years
Physically demanding work: unknown
Severity of CHD: severe
Interventions Intervention characteristics
  • 6 group therapy sessions once every 2 weeks, beginning 1 month following hospital discharge

  • Spouses were invited to attend the 2nd session (topic: the contribution of physical and psychological risk factors to CHD)

  • The progression of material:

    • life stress and the onset of MI

    • the contribution of physical and psychological risk factors to CHD

    • coronary‐prone behaviour

    • home problems

    • RTW

    • the beginning of each session often included a didactic presentation of educational material; followed by an active discussion where participants were encouraged to report their experiences with the topic

  • Duration of intervention: 6 sessions; period not clear

  • Providers: the senior study author, with training in both psychiatry and internal medicine, first‐year residents in internal medicine, two hospital corpsmen, one medical student, chief cardiologist


Control group
  • The control participants received a regular outpatient medical treatment for post‐MI participants.

Outcomes Proportion at work at < 6 months (short term): 3 months
Proportion at work at 6–12 months (medium term): 6, 12 months
Participants working full‐time after > 12 months to < 5 years: 4 years
Clinical anxiety (general and cardiac‐specific)
Adverse events (mortality, reinfarction, bypass)
Identification Sponsorship source: by the Naval Medical Research and Development Command, Department of the Navy, under Research Work Unit ZF 51.524.002.‐5020
Country: USA
Setting: Naval Regional Medical Centre/US Naval Hospital
Possible conflicts of interest: no information provided
Ethics committee approval: not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Twenty‐two patients were randomly assigned to the treatment group and 22 to the control group." No further information provided
Allocation concealment (selection bias) High risk No allocation concealment was described, and the study authors report that, "17 additional post‐MI patients who met the research criteria were referred for treatment."
Although these participants should have been randomly allocated to the study arms, the study authors explain that these participants joined the study expecting the intervention (and examined as a separate treatment group). The results of these non‐randomised people are nevertheless excluded from the quantitative synthesis of results.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Due to the nature of the intervention (group therapy), blinding of participants and personnel would not have been possible.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No blinding of outcome assessors is described, and it is unclear how exactly RTW was assessed. The study authors state that standardised interviews and research questionnaires were used at the follow‐ups. However, no validated questionnaire or validation with independent (unbiased) occupational records is described.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Loss to follow‐up was low across all groups. Three people died before the 3‐4‐year follow‐up, but the study authors do not describe to which of the three study groups these participants were allocated.
Selective reporting (reporting bias) Unclear risk Although the study authors do mention a study protocol, it does not appear to have been published.
Other bias Unclear risk None identified