Clinical trial NCT01655667: Comorbidities and Healthcare Utilisation: Indicators for Improving COPD Diagnosis
Official title: Improving Diagnosis of COPD Through Characterisation of Comorbidities Present at, and Healthcare Utilisation Prior to, Diagnosis of COPD in UK. A Retrospective Primary Care Database.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Diagnosis
Primary Care
Comorbidities
Healthcare utilisation
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Department of Health, United Kingdom
First posted: 2012-08-02
Enrollment: 38859
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged 40 years or older, with an electronically coded diagnosis of COPD made between 1990 and 2009, a minimum of three years continuous practice data including two years prior to and one year post diagnosis to ensure patients recieved COPD therapy post diagnosis (defined as two or more prescriptions for COPD therapies in the 12 months post diagnosis year 1). COPD therapies included short- and long-acting bronchodilators, inhaled corticosteroids, theophylline and leukotriene receptor antagonists.

Brief summary: To characterise and understand the current UK COPD population including demographics, active comorbidities and missed opportunities for COPD diagnosis in the years previous to diagnosis

Detailed description: Using real-world primary care clinical databases, ascertain whether 1) trends in respiratory resource utilisation prior to COPD diagnosis (including lower respiratory tract infections \[LRTIs\], consultations and hospitalisations) could be used as 'flags' to aid earlier diagnosis, and 2) characterize comorbid conditions present at the time of COPD diagnosis, and evaluate the relationship to COPD disease severity and age at diagnosis.

Eligibility criteria: Inclusion Criteria:

* Aged 40 years or older
* Electronically coded diagnosis of COPD made between 1990 and 2009
* A minimum of three years continuous practice data including two years prior to and one year post diagnosis to ensure patients recieved COPD therapy post diagnosis
* Recieved two or more prescriptions for COPD therapies in the 12 months post diagnosis year 1.

Exclusion Criteria:

* Aged less than 40 years
* No diagnosis of COPD between 1990 and 2009
* Less than three years continuous practice data including two years prior to and one year post diagnosis
* Less than two prescriptions for COPD therapies in the 12 months post diagnosis year 1.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Research in Real Life Ltd
state: Cambridgeshire
Study officials:
affiliation: Research in Real-Life Ltd
name: David B Price, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: Dermot Ryan, MBBS
role: STUDY_DIRECTOR
affiliation: Peninsula College of Medinicne and Dentistry
name: Rupert Jones, MBBS
role: STUDY_DIRECTOR
affiliation: University of Cape Town
name: Eric Bateman, MD
role: STUDY_DIRECTOR
affiliation: Department of Health, United Kingdom
name: Matt Kearney, MPH
role: STUDY_DIRECTOR
References:
citation: Jones RC, Price D, Ryan D, Sims EJ, von Ziegenweidt J, Mascarenhas L, Burden A, Halpin DM, Winter R, Hill S, Kearney M, Holton K, Moger A, Freeman D, Chisholm A, Bateman ED; Respiratory Effectiveness Group. Opportunities to diagnose chronic obstructive pulmonary disease in routine care in the UK: a retrospective study of a clinical cohort. Lancet Respir Med. 2014 Apr;2(4):267-76. doi: 10.1016/S2213-2600(14)70008-6. Epub 2014 Feb 13.