Outcome measures between baseline and 3 months
| Outcome | Measurement |
|---|---|
| Primary | |
| Cost-effectiveness | Standard treatment costs and health service utilisation ΔHealth-related quality of life (SRI14 15 questionnaire and EQ-5D) |
| Clinical effectiveness | ΔPaCO2 between baseline and 3 months |
| Secondary | |
| Patient-centred | |
| Symptoms | Medical Research Council dyspnoea score;16 Epworth sleepiness score;17 HAD score18 |
| Proxy healthcare-related quality of life | EQ-5D-5 L by partner and/or carer |
| Body composition | Weight Loss, BMI, fat mass, fat-free mass, fat-free mass index, neck circumference (cm), chest circumference (cm), waist circumference (cm), hip circumference (cm), waist-to-hip ratio |
| Non-invasive ventilation adherence | Hours per night use |
| Physician-centred | |
| Daytime gas exchange | PaO2, PaCO2, pH, HCO3−, packed cell volume of haemoglobin |
| Spirometry | Forced expiratory volume in 1 s, forced vital capacity |
| Exercise capacity | 6MWT |
| Limited overnight polygraphy | Outpatient SpO2 and HR; inpatient SpO2, TcCO2 and HR |
| Sleep quality | 14-day actigraphy* |
| Physical activity | 14-day actigraphy* |
| Cardiovascular | Blood pressure and HR |
| Healthcare organisation-centred | |
| Health economics | Healthcare utilisation (total bed days, premium and standard nurse-interaction time, premium and standard doctor-interaction time, staff time for non-invasive ventilation set-up, frequency of setting changes, premium and standard nurse technical and nursing support postdischarge, outpatient appointments, outpatient reviews, telephone consultations, GP consultations, emergency care attendances costed as per standard treatment costs, equipment cost, hospital admissions) |
*Measured using Philips Actiwatch spectrum.
6MWT, 6 min walk test; BMI, body mass index; EQ-5D, EuroQol-5 dimensions; GP, general practitioner; HAD, hospital anxiety and depression; HCO3−, arterial bicarbonate level; HR, heart rate; PaCO2, arterial partial pressure of carbon dioxide; PaO2, arterial partial pressure of oxygen; SpO2, oxygen saturation; SRI, severe respiratory insufficiency questionnaire; TcCO2, transcutaneous carbon dioxide level.