Summary of the selection process of the core outcomes from the longlist
| COPD exacerbation outcomes considered | Delphi survey results | Consensus meeting | |||
| Patients and patient representatives | Health professionals | Researchers | Patients and patient representatives | Health professionals and researchers | |
| Death outcomes | |||||
| Death from COPD exacerbation | 81.8 | 94.5 | 96.9 | ||
| Death from any cause | 68.5 | 74.8 | 84.0 | 100 | 100 |
| Clinical and physiological outcomes | |||||
| Anxiety | 35.5 | 27.0 | 28.3 | ||
| Breathlessness | 79.3 | 93.3 | 94.9 | ||
| Chest discomfort | 15.8 | 5.8 | 8.2 | ||
| Fatigue | 54.2 | 46.3 | 44.7 | ||
| Cough | 49.3 | 54.3 | 53.6 | ||
| Coughing up blood (haemoptysis) | 62.1 | 58.3 | 46.8 | ||
| Production of dark-coloured sputum | 56.7 | 58.5 | 53.6 | ||
| Sputum amount | 38.4 | 42.0 | 35.5 | ||
| Sputum thickness (ease of expectoration) | 40.4 | 41.8 | 29.0 | ||
| Wheeze | 39.4 | 46.8 | 35.2 | ||
| Appetite | 24.6 | 17.5 | 14.0 | ||
| Change in weight | 33.5 | 25.8 | 23.9 | ||
| Respiratory muscle strength | 65.5 | 58.8 | 47.8 | ||
| Low mood/depression | 41.9 | 35.5 | 40.6 | ||
| Sleep quality | 51.7 | 38.3 | 35.5 | ||
| Early-morning symptoms | 36.5 | 32.0 | 25.6 | ||
| Night-time symptoms | 45.8 | 50.3 | 41.3 | ||
| Treatment success (or failure) | 80.3 | 87.8 | 89.1 | ||
| Worsening of symptoms after the initial treatment | 71.9 | 78.5 | 77.1 | ||
| Disease progression | 83.7 | 88.8 | 86.7 | ||
| Future exacerbations | 75.9 | 89.3 | 90.4 | ||
| Lung function during and immediately after the exacerbation | 71.4 | 54.3 | 43.0 | 7.7 | 11.1 |
| Permanent deterioration in lung function | 87.7 | 88.5 | 82.3 | ||
| Levels of oxygen and carbon dioxide in the blood (arterial blood gases) | 76.4 | 80.3 | 75.4 | ||
| Development of pneumonia | 76.4 | 86.8 | 83.6 | ||
| Development of resistant bacteria | 73.4 | 80.8 | 70.6 | ||
| Damage of lung cells and lung tissue | 81.3 | 71.5 | 57.3 | 38.5 | 22.2 |
| Infection by bacteria (bugs) or viruses | 72.4 | 68.0 | 64.8 | 92.9 | 68.4 |
| Inflammation in the lungs/airways | 73.4 | 61.5 | 49.1 | 50.0 | 27.8 |
| Adverse event outcomes | |||||
| Adverse events of treatments | 60.6 | 58.3 | 65.9 | ||
| Serious adverse events from treatments | 76.8 | 89.5 | 93.5 | ||
| Development and/or progression of other diseases (e.g. heart attack) | 67.5 | 69.5 | 69.6 | ||
| Resource use outcomes | |||||
| Need for hospital admission for the presenting exacerbation | 69.0 | 84.6 | 90.8 | 100 | 100 |
| Length of hospital stay for the exacerbation | 45.3 | 62.3 | 68.3 | ||
| Future hospital admissions | 52.2 | 70.5 | 76.5 | 71.4 | 77.8 |
| Need for NIV use for the exacerbation | 64.0 | 83.5 | 81.9 | 61.5 | 78.6 |
| Length of NIV use for the exacerbation | 58.1 | 60.25 | 57.0 | ||
| Need for admission to the ICU for the exacerbation | 71.9 | 86.8 | 88.7 | ||
| Length of stay in the ICU for the exacerbation | 63.1 | 72.8 | 71.0 | 38.5 | 50 |
| Need for additional medications to achieve symptom control | 64.5 | 59.5 | 57.3 | ||
| Need for long-term administration of supplemental oxygen after the exacerbation | 58.6 | 62.8 | 66.9 | ||
| Need for long-term use of NIV after the exacerbation | 55.7 | 69.5 | 65.5 | ||
| Life-impact outcomes | |||||
| Ability to exercise | 57.6 | 51.0 | 60.4 | ||
| Physical strength | 48.8 | 38.3 | 35.5 | ||
| Walking distance | 57.6 | 67.3 | 68.3 | ||
| Activities of daily living | 70.4 | 82.5 | 84.6 | ||
| Health-related quality of life | 75.4 | 82.5 | 87.7 | ||
| Social engagement/isolation | 54.2 | 50.5 | 50.5 | ||
| Treatment adherence | 72.4 | 83.8 | 84.6 | ||
| Impact on family members and caregivers | 56.7 | 50.3 | 47.4 | ||
| Impact on sexual function | 36.0 | 36.3 | 37.5 | ||
| Sources of outcomes | Outcome selection results | ||||
| ▪ Methodological systematic reviews | ▪ Included | ||||
| ▪ Qualitative interviews | ▪ Inconclusive | ||||
| ▪ Delphi survey (round 1) | ▪ Excluded | ||||
Data are presented %. Percentages refer to the proportion of participants who consider a particular outcome critical. NIV: noninvasive ventilation; ICU: intensive care unit.