Table 1

The patient outcomes measured in the trial

Method of assessmentOutcomeMeasurement tool (where appropriate)
Primary outcomeResearch coordinator blinded to group allocationPhysical functionRivermead Mobility Index 3 months postrandomisation
Secondary outcomes
HospitalResearch coordinators
  • Length of stay

  • ICU readmission rate

  • Survival to hospital discharge

  • Weekly physical function

  • Weekly levels of fatigue, breathlessness, appetite, pain and joint stiffness

  • Weekly presence of delirium

  • Weekly hand grip strength

  • Rivermead Mobility Index

  • Visual analogue scores

  • Confusion-Agitation Method for ICU

  • Hand grip dynamometry

3 monthsResearch coordinator blinded to group allocation
  • HRQoL

  • Levels of fatigue, breathlessness, appetite, pain and joint stiffness, patient satisfaction*, healthcare resource use, anxiety and depression

  • Nutritional status (subjective global assessment of nutrition), weight/BMI, hand grip strength, physical mobility, post-traumatic stress disorder symptomatology

  • Total, Physical Component Score and Mental Component Score SF-12 score, Visual analogue score

  • Patient satisfaction measure, Health Economic Questionnaire, Hospital Anxiety and Depression (HAD) Questionnaire

  • Physical component of the Subjective Global Assessment of Nutrition tool

  • Hand grip dynamometry, 2 m timed up-and-go time, Davidson's Trauma Scale Score (DTS)

6 monthsPostal questionnaires
  • Survival, physical function

  • HRQoL

  • Levels of fatigue, breathlessness; appetite; pain and joint stiffness, Healthcare resource use, Anxiety and depression

  • Post-traumatic stress disorder symptomatology

  • Rivermead Mobility Index, Total, Physical Component Score, and Mental Component Score SF-12 score, Visual analogue score

  • Health economic questionnaire, Hospital Anxiety and Depression (HAD) Questionnaire

  • Davidson's Trauma Scale Score (DTS)

12 monthsPostal questionnaires
  • Survival, Physical function

  • HRQoL

  • Levels of fatigue, breathlessness, appetite, pain and joint stiffness

  • Healthcare resource use, anxiety and depression

  • Post-traumatic stress disorder symptomatology

  • Rivermead Mobility Index, Total, Physical Component Score, and Mental Component Score SF-12 score, Visual analogue score

  • Health Economic Questionnaire, HAD Questionnaire

  • Davidson's Trauma Scale Score (DTS)

  • * The patient satisfaction measure used in the trial was derived based on data obtained in the pretrial work, especially the qualitative research in reference14. The tool is available on the RECOVER page of the ECTU website (http://www.clinicaltrials.ed.ac.uk).

  • HRQoL, health-related quality of life; ICU, intensive care unit.