Non-sedation—Does it improve health-related quality of life after critical illness? A 3-month follow-up sub-study of the NONSEDA trial

Background: Critical illness is associated with severely impaired health-related quality of life (HRQoL) for years following discharge. The NONSEDA trial was a multicenter randomized trial on non-sedation versus sedation with a daily wake-up trial in critically ill, mechanically ventilated patients in Scandinavia. The aim of this sub-study was to assess the effect of non-sedation on HRQoL and degree of independence in activities in daily living (ADL) 3 months post-ICU. Methods: All survivors were asked to complete the Medical Outcomes Study Short-Form 36 questionnaire (SF-36) and the Barthel Index 3 months post-ICU. To limit missing data, reminders were sent. If unsuccessful, telephone interviews could be used. Outcomes were the level of HRQoL and ADL-function in each group. All outcomes were assessed blinded. Results: Of the 700 patients included 412 survived to follow-up. A total of 344 survivors participated (82%). Baseline data were equal between the two groups. Mean SF-36 scores for the non-sedated vs sedated patients were as follows: Physical Function 45 vs 40, P =.69, Bodily Pain: 61 vs 52, P =.81, General Health: 50 vs 50, P =.84, Vitality: 42 vs 44, P =.85, Social Function: 75 vs 63, P =.85, Role Emotional: 58 vs 50, P =.82, Mental Health: 70 vs 70, P =.89, Role Physical: 25 vs 28, P =.32, Physical Component Score: 38 vs 37, P =.81, Mental Component Score: 48 vs 46, P =.94, Barthel Index: 20 vs 20, P =.74. Conclusion: Randomization to non-sedation neither improved nor impaired health-related quality of life or degree of independence in activities in daily living 3 months post-ICU discharge.