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

Andersson 2010.

Methods Study design: parallel RCT
Recruitment: AMI, CABG, PCI patients recruited from April 1997‐October 2000
Allocation: envelope
Blinding: not blinded
Randomisation: no Information provided
Follow‐up(s): yearly up to 5 years
Description: combined inpatient rehabilitation programme for women
Participants Baseline characteristics
Intervention group
  • Mean age (SD): 52.5 (6.2)

  • Sex (male %): 0

  • Number of participants randomised: 69

  • Working before CHD: 54


Control group
  • Mean age (SD): 54.3 (6.1)

  • Sex (male %): 0

  • Number of participants randomised: 61

  • Working before CHD: 42


Inclusion criteria
  • Female

  • < 65 years of age, working age

  • Resident of Stockholm

  • CHD: hospitalised for AMI, CABG or PCI


Exclusion criteria
  • Non‐Swedish speaking

  • Heart failure

  • Unstable angina pectoris

  • Other disabling diseases including drug abuse


Baseline imbalances:
Physically demanding work (i.e. white‐ vs blue‐collar): unknown
Severity of CHD: less
Interventions Intervention characteristics
Group programme (6‐10 women) aimed at promoting and maintain lifestyle changes
  • 2‐week residential course

  • 5 inpatient days after 2 months

  • 2 follow‐ups per year, each requiring 2 inpatient days

  • Group activities included:

    • seminar/discussions (group and individual counselling with a cardiologist, psychologist, psychiatrist, dietician, physiotherapist)

    • practical activities: e.g. healthy cooking

    • physical activities: walking, aerobics, Yoga, Qi Gong, water‐aerobics

    • daily relaxation techniques: breathing exercises, meditation

    • activities with friends and families on weekend

    • psychosocial intervention: an interactive, self‐instructional programme “Stress as an Opportunity”.

  • Duration of intervention: 5 years

  • Providers: trained personnel


Control group
  • Conventional post‐hospitalisation care varied by hospital, e.g. physiotherapy twice per week for 4 weeks

  • information on healthy food and adverse effects of nicotine

Outcomes Proportion at work at 6–12 months (medium term): 12 months
Proportion at work at > 12 months to < 5 years (long term): 3 years
Proportion at work at 5 years (extended long term): 5 years
Number of participants at work calculated from proportions provided and number of participants working at baseline
Becks Depression Inventory, Gothenburg QoL Inventory (only baseline results reported)
Adverse events (mortality, emergency room visits)
Identification Sponsorship source: supported by Swedish Research Council, Swedish Heart & Lung Foundation, regional agreement on medical training & clinical research (ALF), Stockholm County Council, Saltsjöbaden Hospital and the Dept. of Cardiology at the Karolinska Univ. Hospital
Country: Sweden
Setting: single‐centre: Saltsjöbaden Hospital near Stockholm; inpatient
Possible conflicts of interest: none reported
Ethics committee approval: approved by the Karolinska Hospital Ethics Committee and all participants gave informed written consent.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “The randomisation was not stratified as the number of eligible patients was presumed to be too small for a stratified randomisation.” No further information provided.
Allocation concealment (selection bias) Low risk Quote: “All baseline examinations were performed before randomisation… Patients were logged into the study and then called to baseline examination. After that, a biomedical scientist, not involved in the study, opened the envelope that revealed the group allocation.”
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 No blinding mentioned
Incomplete outcome data (attrition bias) 
 All outcomes High risk Results only given as the proportion (%) employed, on sick leave or with disability pension (not mutually exclusive) for year 1, 3 and 5 after study onset. No information regarding the actual number of study participants employed at the 1‐, 3‐ or 5‐year follow‐ups were reported or how many study participants were followed at each of the follow‐up time points (loss‐to‐follow‐up). Study authors contacted, no further information provided. No information about how the drop‐outs (n = 19) were distributed across the groups ⇢ imbalanced group sizes (I: n = 69; C: n = 61)
Selective reporting (reporting bias) Low risk No study protocol available, however no difference in proportion of employed study participants was detected and still was reported, suggesting there was no reporting bias (towards only reporting statistically significant results).
Other bias Unclear risk None identified