Table 3

Overview of assessments by stage of study

Stage 0Stage 1Stage 2Stage 3Stage 4End
Time pointEligibilityBaselineEnd of week
End of week
End of week
End of 3 monthsWithdrawal or completion
History and demographicsDemographics
 Physical examination
 Medicines Hx and LTOT
 Smoking Hx
 6-month weight Hx
InvestigationsLFT, FBC, Elec, CC
 Serum testosterone
 End-tidal CO2
 Pulse oximetry
 Vital signs
 Activity Fitbit monitor
Participant mediatedDiary entries
 Epworth SS
 Blinded preference
Research team mediatedAKPS
 Barthel Index
 Blinded preference
 Side effects
EconomicInpatient stay days
 ED visits
 Med/health visits
 Date of death
 PG blood sample
 PK and PD blood sample
 Home sleep study
 Laboratory sleep study
 Driving simulation
 Qualitative interview
 Serum testosterone
  • *Primary endpoint.

  • AKPS, Australian-modified Karnofsky Performance Status; CAT, COPD Assessment Test; CC, creatinine clearance; CCI, Charlson Comorbidity Index; COPD, chronic obstructive pulmonary disease; CO2, carbon dioxide; CRQ-DS, Chronic Respiratory Questionnaire—Dyspnoea Subscale; CRQ-M, Chronic Respiratory Questionnaire—Mastery; ED, emergency department; Elec, electrolytes; Epworth SS, Epworth Sleepiness Scale; ESAS, Edmonton Symptom Assessment Scale; EQ-5D-5L, Five-Level EuroQol five dimensions questionnaire; FEV1/FVC, forced expiratory volume in 1 s over forced expiratory volume; FBC, full blood count; GIC, Global Impression of Change; HADS, Hospital Anxiety and Depression Scale; Hx, history; KSS, Karolinska Sleepiness Scale; LFT, Liver Function Tests; LSQ, Leeds Sleep Questionnaire; LTOT, long-term oxygen therapy; Med, medical; mMRC, Modified Medical Research Council Dyspnoea Scale; PD, pharmacodynamic; PG, pharmacogenetic; PK, pharmacokinetic; SLUMS, St Louis University Mental State Examination; SOWS, Subjective Opioid Withdrawal Scale; ZCBS, Zarit Caregiver Burden Scale (short form).