Table 3.
Overview of assessments by stage of study
| Stage 0 | Stage 1 | Stage 2 | Stage 3 | Stage 4 | End | |||
| Time point | Eligibility | Baseline | End of week 1* |
End of week 2 |
End of week 3 |
End of 3 months | Withdrawal or completion | |
| History and demographics | Demographics | ✓ | ||||||
| Physical examination | ✓ | |||||||
| Medicines Hx and LTOT | ✓ | ✓ | ||||||
| Smoking Hx | ✓ | |||||||
| Height/Weight | ✓ | |||||||
| 6-month weight Hx | ✓ | |||||||
| Investigations | LFT, FBC, Elec, CC | ✓ | ||||||
| Serum testosterone | ✓ | |||||||
| FEV1/FVC | ✓ | |||||||
| End-tidal CO2 | ✓ | ✓ | ✓ | ✓ | ||||
| Pulse oximetry | ✓ | ✓ | ✓ | ✓ | ||||
| Vital signs | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| Activity Fitbit monitor | ✓ | ✓ | ✓ | |||||
| Participant mediated | Diary entries | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| HADS | ✓ | ✓ | ✓ | |||||
| CAT | ✓ | ✓ | ✓ | ✓ | ||||
| CRQ-DS and CRQ-M | ✓ | ✓ | ✓ | |||||
| EQ-5D-5L | ✓ | ✓ | ✓ | ✓ | ||||
| Epworth SS | ✓ | ✓ | ✓ | |||||
| LSQ | ✓ | ✓ | ✓ | |||||
| KSS | ✓ | ✓ | ||||||
| ESAS | ✓ | ✓ | ✓ | |||||
| Blinded preference | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| SOWS | ✓ | |||||||
| Research team mediated | AKPS | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| mMRC | ✓ | ✓ | ✓ | ✓ | ||||
| GIC | ✓ | ✓ | ✓ | ✓ | ✓ | |||
| Barthel Index | ✓ | ✓ | ||||||
| Blinded preference | ✓ | ✓ | ✓ | |||||
| Side effects | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| CCI | ✓ | |||||||
| SLUMS | ✓ | |||||||
| Compliance | ✓ | ✓ | ✓ | ✓ | ||||
| Economic | Inpatient stay days | ✓ | ✓ | ✓ | ✓ | |||
| ED visits | ✓ | ✓ | ✓ | ✓ | ||||
| Med/health visits | ✓ | ✓ | ✓ | ✓ | ||||
| Date of death | ✓ | |||||||
| Substudies | ZCBS | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| 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).