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

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
Participants Baseline characteristics
Intervention group
  • Mean age (SD): 53 ± 5

  • Sex (male %): ‐

  • Number of participants randomised: 48

  • Working before CHD: 48


Control group
  • Mean age (SD): 52 ± 7

  • Sex (male %): ‐

  • Number of participants randomised: 52

  • Working before CHD: 52


Inclusion criteria
  • Successful coronary catheter revascularisation

  • Working patients


Exclusion criteria
  • MI in the last 4 weeks

  • Medical contraindications:

    • unstable angina pectoris

    • cardiac insufficiency (ejection fraction < 50%)

    • haemodynamically relevant valvular defect

    • severe co‐morbidities (chronic obstructive pulmonary disease, tumours, apoplexy etc.)

  • Planned retirement

  • Housewives (difficulties to specify when their working day begins)


Baseline imbalances:
Recruitment Methods:
Physically demanding work: unknown
Severity of CHD: less severe
Interventions Intervention characteristics
  • RTW consultation

    • Participants and their family doctors were provided with information about RTW

    • Participants were verbally briefed by the investigator and the clinic to acquire general information about RTW

    • Family doctor received information via medical reports

    • Information session for all participants and their family doctors during the 1st week

    • Control‐and‐workload ECG test (if there was an ischaemia or a clinically suspected restenosis found, there was another ECG appointment)

  • Duration of intervention: not reported

  • Providers: study investigator, physician, family doctor


Control group
  • No specific information about RTW

Outcomes Proportion at work at < 6 months (short term): 4 months
Duration of sick leave
EuroQOL (only baseline reported)
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
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