COMPARABILITY OF POPULATION DEFINITIONS WITHIN & BETWEEN GLOBAL DATABASES – DEVELOPING TOOLS FOR OBSERVATIONAL RESEARCH (ACO Population Definitions)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational, historical database study

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

  Asthma

  Asthma-chronic obstructive pulmonary disease overlap syndrome

Population studied

• Short description of the study population:
  Chronic obstructive pulmonary disease, Asthma, and Asthma-chronic obstructive pulmonary disease overlap syndrome patients
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  To inform standardised methods for future ACO observational research, the study aims to: test various smoking-related ACO population definitions (based on previous evidence), evaluating their respective prevalence and agreement (i) within and (ii) between a number of national and international research quality databases
• Outcomes:
  The primary outcomes of the study are the prevalence of subpopulations B and C, relative to A within each of the parent population series (COPD, ACOS, Asthma, Control) and the agreement within each database between the most selective subpopulations’ definitions within each parent series (i.e. subpopulation C) and between different databases
• Data analysis plan:
  Evaluation of:1. Outcome 1 (total number of patients) will require absolute count of patient numbers.2. Outcome 2 (population prevalence) will require evaluation of the percent prevalence within different Parent Series.3. Outcomes 3 & 4 (agreement across different population definitions: 1C vs 2C vs 3C vs 4C) will use the kappa statistic (k) or suitable alternatives (e.g. Chi-squared)