Variables relating to the impact of disease, treatment and healthcare utilisation to be collected in NOVELTY
Variable | Collection# | ||||
Baseline | Every 3 months | Yearly | |||
Physician-reported | Patient-reported | Patient-reported | Physician-reported | Patient-reported | |
Impact on daily activity and quality of life | |||||
HRQoL | |||||
SGRQ | ✓ | ✓ | |||
EQ-5D-5L | ✓ | ✓ | ✓ | ||
WPAI | ✓ | ✓ | |||
Treatment(s) during previous 12 months | |||||
Asthma/COPD treatments | ✓ | ✓ | ✓ | ✓ | ✓ |
Treatment duration and frequency | ✓ | ✓ | ✓ | ✓ | ✓ |
Posology | ✓ | ✓ | |||
Patterns of use and treatment adherence for asthma/COPD treatments | ✓ | ✓ | ✓ | ✓ | |
Burden of out-of-pocket asthma/COPD treatment expenses¶ | ✓ | ✓ | |||
Reasons for switching/ interruptions/discontinuations of each asthma or COPD treatment | ✓ | ✓ | ✓ | ✓ | |
Asthma/COPD treatment satisfaction | ✓ | ✓ | ✓ | ||
Concomitant medications | ✓ | ✓ | |||
Healthcare utilisation during previous 12 months (eCRF) or previous 3 months (PROs) | |||||
Medications, emergency and nonemergency physician visits | ✓ | ✓ | ✓ | ✓ | ✓ |
Respiratory and nonrespiratory hospitalisations | ✓ | ✓ | ✓ | ✓ | ✓ |
Out-of-pocket expenses (USA only) | ✓ | ✓ | |||
Exacerbations, emergency department visits, hospitalisations, days in ICU | ✓ | ✓ | ✓ | ✓ | ✓ |
Tests performed during exacerbations | ✓ | ✓ |
COPD: chronic obstructive pulmonary disease; eCRF: electronic case report form; EQ-5D-5L: EuroQol 5 dimensions 5 levels health questionnaire; HRQoL: health-related quality of life; ICU: intensive care unit; NOVELTY: a NOVEL observational longiTudinal studY; PRO: patient-reported outcome; SGRQ: St George's Respiratory Questionnaire; WPAI: work productivity and activity impairment. #: baseline and yearly data will be collected from healthcare professionals during clinical visits, while 3-monthly data will be collected directly from the patient via follow up by web-based platform or telephone, and in conjunction with their yearly clinical visits. ¶: patients will be asked to consider the burden of out-of-pocket expenses in the 12 months prior to visit.