Figures
- FIGURE 1
NOVELTY study design. COPD: chronic obstructive pulmonary disease; eCRF: electronic case report form; EMR: electronic medical record; HCU: healthcare utilisation; HRQoL: health-related quality of life; PRO: patient-reported outcome.
Tables
- TABLE 1
Patient demographics and characteristics to be measured in NOVELTY
Variable Collection# Baseline Every 3 months Yearly Physician-reported Patient-reported Patient-reported Physician-reported Patient-reported Informed consent ✓ Demographics Age, ethnicity, gender, socioeconomic status, income (USA only), insurance status/payee (USA only), history of respiratory interventional trials participation ✓ Occupation ✓ ✓ Characteristics Height (post-baseline for adolescents only), weight, BMI, waist circumference, heart rate, pregnancy status ✓ ✓ Risk factors for development of obstructive lung disease Smoking status and history, environmental and occupational exposure to pollutants, allergens ✓ ✓ BMI: body mass index; NOVELTY: a NOVEL observational longiTudinal studY. #: 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.
- TABLE 2
Disease-related variables to be measured in NOVELTY
Variable Collection# Baseline Every 3 months Yearly Physician-reported Patient-reported Patient-reported Physician-reported Patient-reported Asthma/COPD information Physician-reported diagnosis and severity ✓ Age at diagnosis, personal and family history of asthma/COPD and allergies ✓ Comorbidities ✓ ✓ Asthma/COPD complications, recent respiratory diseases (e.g. RTI) ✓ ✓ ✓ ✓ ✓ Exacerbations ✓ ✓ ✓ ✓ ✓ Symptom assessments: CAAT¶, RSQ ✓ ✓ ✓ Symptom assessments: ACT+, SGRQ ✓ ✓ mMRC dyspnoea score ✓ CAPTURE screening tool ✓ Lung function measurements (FEV1, FVC, PEF, FEF25–75%, IC, calculated FEV1/FVC ratio, calculated FEV1% predicted)§ ✓ ✓ Bronchodilator reversibility test ✓ FeNO ✓ Biomarkers (with specific consent)ƒ Blood: differential white blood cell count ✓ ✓ Blood: serum and plasma## for biomarker, metabolomic and proteomic analysis ✓ ✓ Blood: DNA and RNA, for genomic and transcriptomic analysis ✓ Urine sample ✓ ACT: asthma control test; CAAT: chronic airways assessment test; CAPTURE: COPD Foundation Primary Care Tool for Undiagnosed Respiratory Disease and Exacerbation Risk; COPD: chronic obstructive pulmonary disease; FEF25–75%: forced expiratory flow at 25–75% of the forced vital capacity; FeNO: fractional exhaled nitric oxide; FEV1: forced expiratory volume over 1 s; FVC: forced vital capacity; IC: inspiratory capacity; mMRC: modified Medical Research Council; NOVELTY: a NOVEL observational longiTudinal studY; PEF: peak expiratory flow; RSQ: Respiratory Symptoms Questionnaire; RTI: respiratory tract infection; SGRQ: St George's Respiratory Questionnaire. #: 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. ¶: the CAAT is a modified form of the validated COPD assessment test (CAT), which, with consent of the copyright holder (GlaxoSmithKline, Brentford, UK), excludes specific references to COPD in order to also assess patients without a COPD diagnosis; a small subset of patients with COPD will complete both the CAAT and CAT at baseline and year 1, to evaluate the equivalence of the two tests. +: only for patients with an asthma diagnosis, for comparison with the CAAT. §: for sites where spirometers are provided and data collected centrally, quality control/over-read and Best Test Review will be performed at baseline. ƒ: in Brazil, no samples will be collected; in China and Denmark, only samples for haematology will be collected; in Italy, no samples for DNA or RNA analysis will be collected; samples will be collected at each yearly visit in Australia, Canada, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, the UK and the USA, and at year 1 only in other countries. ##: plasma will not be collected from adolescent patients.
- TABLE 3
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.
Supplementary Material
Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.
Supplementary material 00036-2018_supp
