TABLE 3

Variables relating to the impact of disease, treatment and healthcare utilisation to be collected in NOVELTY

VariableCollection#
BaselineEvery 3 monthsYearly
Physician-reportedPatient-reportedPatient-reportedPhysician-reportedPatient-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.