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
Control group
Inclusion criteria
Exclusion criteria
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
Control group
|
|
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 |