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P138 An innovative approach to study design: using electronic medical records to inform the feasibility and design of the novelty study (a novel observational longitudinal study on patients with asthma and/or COPD)
  1. HK Reddel1,
  2. M Gerhardsson de Verdier2,
  3. A Agustí3,
  4. R Beasley4,
  5. EH Bel5,
  6. C Janson6,
  7. B Make7,
  8. RJ Martin7,
  9. I Pavord8,
  10. D Postma9,
  11. D Price10,
  12. C Keen2,
  13. A Gardev2,
  14. S Rennard2,
  15. A Sveréus2,
  16. AT Bansal11,
  17. L Brannman2,
  18. N Karlsson2,
  19. J Nuevo2,
  20. F Nyberg2,
  21. S Young2,
  22. J Vestbo12
  1. 1Woolcock Institute of Medical Research, Sydney, Australia
  2. 2AstraZeneca, Madrid, Spain
  3. 3Hospital Clinic University of Barcelona, Barcelona, Spain
  4. 4Medical Research Institute of New Zealand, Wellington, New Zealand
  5. 5Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands
  6. 6Uppsala University, Uppsala, Sweden
  7. 7National Jewish Health and University of Colorado, Denver, USA
  8. 8University of Oxford, Oxford, UK
  9. 9University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands
  10. 10Research in Real-Life, Singapore, Singapore
  11. 11Acclarogen Ltd, Cambridge, UK
  12. 12The University of Manchester, Manchester, UK

Abstract

Introduction Asthma and COPD have traditionally been viewed as distinct diseases. While they have overlapping biological mechanisms, past studies often focused on specific aspects of each disease based on a single diagnostic label, and many clinical trial populations were defined by strict enrolment criteria with limited generalisability. NOVELTY is a prospective, multinational, observational, longitudinal cohort study aiming to enrol 14,800 patients aged ≥12 years with a diagnosis or suspected diagnosis of asthma and/or COPD. In this population, the objectives of NOVELTY are to: (i) describe patient characteristics, treatment patterns and burden of illness over time in clinical practice; and (ii) use biomarkers and clinical parameters to identify phenotypes and endotypes associated with differential outcomes for symptom burden, clinical evolution and healthcare utilisation.

Aim This feasibility analysis of electronic medical records (EMRs) aimed to understand the potential study population, assess patient numbers across disease severities and evaluate EMRs as a data source for NOVELTY.

Methods EMRs from patients with asthma and/or COPD were identified from national databases covering primary and specialist care in 11 countries (Table). Disease severity was classified using treatment- and/or lung function-based algorithms for asthma and COPD. EMR variable coverage and completeness were assessed for standardised clinical, laboratory and physiological data and patient-reported outcomes (PROs).

Results EMRs for 921,888 patients with asthma, 958,945 with COPD and 117,893 with both diagnoses were identified. EMRs routinely documented patient demographics and characteristics, but many disease- and treatment-related data, and PROs/symptoms required for evaluation of disease severity and clinical outcomes were frequently missing (not collected or not documented; Table). Disease severity could not be classified in 561,837 patients (asthma) and 355,743 patients (COPD), representing 22−100% and 7−85% of patients across countries.

Conclusions EMR analysis revealed numbers of patients per country potentially eligible for NOVELTY. Many variables required to meet NOVELTY objectives were missing in EMRs (e.g. lung function and PRO/symptoms); therefore, variables in NOVELTY will primarily be documented in electronic case report forms, not EMRs. The lack of lung function data in many countries suggested divergences in diagnosis of asthma/COPD between clinical guidelines (which include lung function tests) and clinical practice.

Abstract P138 Table 1

Range of proportions of patients with asthma and/or COPD for whom EMRs contained any of selected variables

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    BMJ Publishing Group Ltd and British Thoracic Society