title: A novel approach to studying the relationship between subjective and objective measures of cough.
abstract: BACKGROUND
  Currently, no data are available on the relationship between changes in objective and subjective measures of cough, the magnitude of change in cough frequency perceived by patients as clinically meaningful, or the sample sizes required to show significant changes in cough therapeutic trials. Because patients anecdotally report reductions in cough severity while undergoing esophageal testing, we aimed to address these issues by assessing objective and subjective measures of cough with and without an esophageal catheter.
  
  
  METHODS
  Twenty-four-hour cough monitoring was performed on two occasions, with and without esophageal impedance/pH monitoring in 62 patients with chronic cough (mean age 56.8 years [SD±10.8]; 43 women; median cough duration 3.3 years [interquartile range (IQR), 2.0-10.0]). Cough was assessed objectively measuring coughs per hour and subjectively using a numerical cough score and a visual analog scale (VAS), scored separately for day and night, and then averaged to represent each 24-h period.
  
  
  RESULTS
  Objective cough frequency was reduced by a median of 33.3% (IQR, -68.8% to -13.0%; P<.001) with the catheter. The averaged day and night cough scores and VAS scores also significantly decreased, but changes in these did not correlate with decreases in cough frequency. Sample-size calculations suggested that crossover designs using objective cough frequency may be preferable in therapeutic trials.
  
  
  CONCLUSIONS
  These observations provide useful information on the reduction in objective cough frequency scored as an improvement by patients with chronic cough and offer guidance for the design and powering of future therapeutic trials.
  
  
  BACKGROUND
  ISRCTN; No.: ISRCTN62337037; URL: http://www.controlled-trials.com.
authors.affiliation: Respiratory Research Group, University of Manchester, NHS Foundation Trust, Manchester, England; North West Lung Centre, University Hospital of South Manchester, NHS Foundation Trust, Manchester, England.
authors.forename: Angela
authors.initials: A
authors.lastname: Kelsall
authors.affiliation: Neurogastroenterology Unit, University of Manchester, NHS Foundation Trust, Manchester, England.
authors.forename: Lesley A
authors.initials: LA
authors.lastname: Houghton
authors.affiliation: Respiratory Research Group, University of Manchester, NHS Foundation Trust, Manchester, England; Neurogastroenterology Unit, University of Manchester, NHS Foundation Trust, Manchester, England.
authors.forename: Helen
authors.initials: H
authors.lastname: Jones
authors.affiliation: Respiratory Research Group, University of Manchester, NHS Foundation Trust, Manchester, England.
authors.forename: Samantha
authors.initials: S
authors.lastname: Decalmer
authors.affiliation: Respiratory Research Group, University of Manchester, NHS Foundation Trust, Manchester, England; North West Lung Centre, University Hospital of South Manchester, NHS Foundation Trust, Manchester, England.
authors.forename: Kevin
authors.initials: K
authors.lastname: McGuinness
authors.affiliation: Respiratory Research Group, University of Manchester, NHS Foundation Trust, Manchester, England. Electronic address: jacky.smith@manchester.ac.uk.
authors.forename: Jaclyn A
authors.initials: JA
authors.lastname: Smith
mesh_terms: D000368:Aged; D057785:Catheters; D002908:Chronic Disease; D002940:Circadian Rhythm / Q000502:physiology; D003371:Cough / Q000453:epidemiology* / Q000503:physiopathology*; D050782:Esophageal pH Monitoring; D006801:Humans; D015994:Incidence; D008297:Male; D008365:Manometry; D008875:Middle Aged; D010147:Pain Measurement; D012720:Severity of Illness Index