Table 2

Key secondary outcomes

Domain/outcomeTimepointMeasurement instrument
All-cause mortalityUp to 6 months after index ICU admissionNumber of deaths from any cause including in-hospital mortality (using hospital administrative records, electronic medical records, municipal personal records database and the 3-month and 6-month follow-up with surrogates)
Mental health condition
Subdomains: anxiety and depression
At month 3 and 6Patient-reported symptom burden on anxiety and depression assessed by the paper-based Patient Health Questionnaire-4 (screening tool). Higher scores indicate higher impairment60
Mental health condition
Subdomain: post-traumatic stress disorder (PTSD)
At month 6Patient-reported symptom burden on PTSD assessed by the paper-based questionnaire Impact of Event Scale—Revised. Higher scores indicate greater distress61
Subdomains: memory, visuospatial and visuoconstructional skills
At month 3 and 6Functional outcome assessed by the MiniCog test (two tests: three-item recall task; clock-drawing task). Higher scores indicate better cognitive functioning62 63
Subdomain: verbal fluency
At month 3 and 6Functional outcome assessed by the Animal Naming Test. Higher scores indicate better cognitive functioning64
Physical function
Subdomain: mobility
At month 3 and 6Patient’s walking ability and risk of fall assessed by the Timed Up and Go Test. Higher scores indicate higher impairment65
Physical function
Subdomain: muscle strength
At month 3 and 6Patient’s muscle and nerve function assessed by the Hand-Grip-Strength Test measured with a dynamometer (average strength (in kg) of three trials for the dominant hand)66
Health-related quality of life (HRQoL)At month 3 and 6Patient’s self-reported HRQoL assessed by the EuroQol—5 dimensions—5 level descriptive system (items: mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and the Visual Analogue Scale, a thermometer-like rating scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate better HRQoL67 68
Organ dysfunctionAt month 3 and 6Number of patients with organ dysfunction as assessed by general practitioner or study personnel/ investigator
Pulmonary function and symptoms—dyspnoeaAt month 6Self-perceived breathlessness during daily activities graded by the Modified British Medical Research Council Dyspnea Scale (range 0–4). Higher score indicate higher impairment69 70
Outpatient ventilationUp to 6 months after index ICU dischargeTotal duration (in days) of mechanical ventilation
Functioning and disabilityAt month 6Patient-reported General Disability Score, as measured by the WHO Disability Assessment Schedule V.2.0 for activity limitation and participation restriction, 12-item short version, self-administered questionnaire. The raw score is calculated by summing the values for each item. Higher scores indicate greater disability71 72
ICU and hospital length of stayAt month 6Total number of days spent at ICU, and in hospital
Employment statusAt month 3 and 6Return to work, or change in employment status
  • ICU, intensive care unit.