Pfund 2001.
Methods |
Study design: parallel RCT Recruitment: continuously employed patients (≤ 60 years) after successful coronary catheter revascularisation; March1998‐December 1999 Allocation: not reported Blinding: not reported Randomisation: no method described Follow‐up(s): 4 months Description: intervention group received a RTW consultation regarding RTW including a proposed date for RTW in the 1st week after the intervention |
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Participants |
Baseline characteristics Intervention group
Control group
Inclusion criteria
Exclusion criteria
Baseline imbalances: ‐ Recruitment Methods: Physically demanding work: unknown Severity of CHD: less severe |
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Interventions |
Intervention characteristics
Control group
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Outcomes | Proportion at work at < 6 months (short term): 4 months Duration of sick leave EuroQOL (only baseline reported) |
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Identification |
Sponsorship source: Ernst und Berta‐Grimmke‐Stiftung, Düsseldorf Country: Germany Setting: multi‐centred: medical clinic III of the University of Cologne and the joint practice Haubrichhof, Cologne; inpatient Possible conflicts of interest: no information provided Ethics committee approval: not reported |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of sequence generation is not described. |
Allocation concealment (selection bias) | Unclear risk | No method of allocation concealment is described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of the study participants was not mentioned. The hospital personnel and study researchers would have been aware of the group allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding of outcome assessors is mentioned, and RTW was assessed with an interview. No additional checks of work status with external sources is mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Overall there were 104 patients included in the study (intention‐to‐treat) of which 100 (96%) were interviewed after 4 months." Unclear what happened to the 4 dropouts and how they were allocated |
Selective reporting (reporting bias) | Unclear risk | No study protocol was available. Although the intervention did not result in a statistically significant difference in short‐term (4‐month) RTW rates, the results were reported. However, the statistically significant differences between RTW among private vs pubically insured participants (which did not directly address the study aims) are overemphasised |
Other bias | Unclear risk | None identified |