title: TargetCOPD: a pragmatic randomised controlled trial of targeted case finding for COPD versus routine practice in primary care: protocol.
abstract: BACKGROUND
  Many people with clinically significant chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. There are a number of small studies which have examined possible methods of case finding through primary care, but no large RCTs that have adequately assessed the most cost-effective approach.
  
  
  METHODS
  In this study, using a cluster randomised controlled trial (RCT) in 56 general practices in the West Midlands, we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice. Using an individual patient RCT nested in the Targeted arm, we plan also to compare the effectiveness and cost-effectiveness of Active case finding using a postal questionnaire (with supplementary opportunistic questionnaires), and Opportunistic-only case finding during routine surgery consultations.All ever-smoking patients aged 40-79 years, without a current diagnosis of COPD and registered with participating practices will be eligible. Patients in the Targeted arm who report positive respiratory symptoms (chronic cough or phlegm, wheeze or dyspnoea) using a brief questionnaire will be invited for further spirometric assessment to ascertain whether they have COPD or not. Post-bronchodilator spirometry will be conducted to ATS standards using an Easy One spirometer by trained research assistants.The primary outcomes will be new cases of COPD and cost per new case identified, comparing targeted case finding with routine care, and two types of targeted case finding (active versus opportunistic). A multilevel logistic regression model will be used to model the probability of detecting a new case of COPD for each treatment arm, with clustering of patients (by practice and household) accounted for using a multi-level structure.A trial-based analysis will be undertaken using costs and outcomes collected during the trial. Secondary outcomes include the feasibility, efficiency, long-term cost-effectiveness, patient and primary care staff views of each approach.
  
  
  CONCLUSIONS
  This will be the largest RCT of its kind, and should inform how best to identify undiagnosed patients with COPD in the UK and other similar healthcare systems. Sensitivity analyses will help local policy-makers decide which sub-groups of the population to target first.
  
  
  BACKGROUND
  Current controlled trials ISRCTN14930255.
authors.forename: Rachel E
authors.initials: RE
authors.lastname: Jordan
authors.affiliation: School of Health and Populations Sciences, University of Birmingham, Birmingham, UK. p.adab@bham.ac.uk.
authors.forename: Peymané
authors.initials: P
authors.lastname: Adab
authors.forename: Sue
authors.initials: S
authors.lastname: Jowett
authors.forename: Jen L
authors.initials: JL
authors.lastname: Marsh
authors.forename: Richard D
authors.initials: RD
authors.lastname: Riley
authors.forename: Alexandra
authors.initials: A
authors.lastname: Enocson
authors.forename: Martin R
authors.initials: MR
authors.lastname: Miller
authors.forename: Brendan G
authors.initials: BG
authors.lastname: Cooper
authors.forename: Alice M
authors.initials: AM
authors.lastname: Turner
authors.forename: Jon G
authors.initials: JG
authors.lastname: Ayres
authors.forename: Kar Keung
authors.initials: KK
authors.lastname: Cheng
authors.forename: Kate
authors.initials: K
authors.lastname: Jolly
authors.forename: Robert A
authors.initials: RA
authors.lastname: Stockley
authors.forename: Sheila
authors.initials: S
authors.lastname: Greenfield
authors.forename: Stanley
authors.initials: S
authors.lastname: Siebert
authors.forename: Amanda
authors.initials: A
authors.lastname: Daley
authors.forename: David A
authors.initials: DA
authors.lastname: Fitzmaurice
mesh_terms: D000328:Adult; D000368:Aged; D001291:Attitude of Health Personnel; D003362:Cost-Benefit Analysis; D003371:Cough / Q000209:etiology; D004417:Dyspnea / Q000209:etiology; D058006:General Practice / Q000191:economics / Q000379:methods*; D017048:Health Care Costs; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D011320:Primary Health Care / Q000191:economics / Q000379:methods*; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis*; D012107:Research Design; D012135:Respiratory Sounds / Q000209:etiology; D012907:Smoking; D013147:Spirometry; D013183:Sputum; D011795:Surveys and Questionnaires