Health-related quality of life after fast-track treatment results from a randomized controlled clinical equivalence trial

Ghislaine A. P. G. van Mastrigt*, Manuela A. Joore, Fred H. M. Nieman, Johan L. Severens, Jos G. Maessen

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Purpose This randomized clinical equivalence trial was designed to evaluate health-related quality of life (HRQoL) after fast-track treatment for low-risk coronary artery bypass (CABG) patients. Methods Four hundred and ten CABG patients were randomly assigned to undergo either short-stay intensive care treatment (SSIC, 8 h of intensive care stay) or control treatment (care as usual, overnight intensive care stay). HRQoL was measured at baseline and 1 month, and one year after surgery using the multidimensional index of life quality (MILQ), the EQ-5D, the Beck Depression Inventory and the State-Trait Anxiety Inventory. Results At one month after surgery, no statistically significant difference in overall HRQoL was found (MILQ-score P-value = .508, overall MILQ-index P-value = .543, EQ-5D VAS P-value = .593). The scores on the MILQ-domains, physical, and social functioning were significantly higher at one month postoperatively in the SSIC group compared to the control group (P-value = .049; 95% CI: 0.01-2.50 and P-value =.014, 95% CI:0.24-2.06, respectively). However, these differences were no longer observed at long-term follow-up. Conclusions According to our definition of clinical equivalence, the HRQoL of SSIC patients is similar to patients receiving care as usual. Since safety and the financial benefits of this intervention were demonstrated in a previously reported analysis, SSIC can be considered as an adequate fast-track intensive care treatment option for low-risk CABG patients.
Original languageEnglish
Pages (from-to)631-642
JournalQuality of Life Research
Issue number5
Publication statusPublished - Jun 2010


  • Quality of life
  • Intensive care
  • Coronary artery bypass grafting
  • Randomized controlled trial


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