Chest
Original ResearchSigns and Symptoms of Chest DiseasesValidation of the Cough Quality-of-Life Questionnaire in Patients With Idiopathic Pulmonary Fibrosis
Section snippets
Materials and Methods
This study was performed within the context of a randomized clinical trial of thalidomide to treat cough in IPF.10 It was approved by the Johns Hopkins Medicine Institutional Review Board (Approval # NA 00007590). The trial was a double-blinded, two-treatment, two-period crossover study with two 12-week treatment periods separated by a 2-week drug-free washout period. Participants were recruited between February 2008 and March 2011. All participants provided written informed consent.
Results
Ninety-eight individuals inquired about the study between February 2008 and March 2011. Of the 25 participants who signed informed consent, 24 were eligible for the trial and were randomized. Of the 24 randomized participants, 23 were treated (one left the study because of lack of interest), and 20 completed both treatment periods (three dropped out because of worsening health). The demographic characteristics of participants are shown in Table 1, and further details about the study population
Discussion
Cough is a frequent, disabling symptom in patients with IPF,5 and it is important to be able to precisely quantify the impact of cough-specific quality of life in clinical trials and in the clinical care of patients with IPF.13 The current study demonstrates the validity and reliability of the CQLQ for individuals with IPF.
Construct analysis of the CQLQ showed good internal consistency for the total score and most of the subscales (Table 3). However, the extreme physical complaints and personal
Acknowledgments
Author contributions: Dr Lechtzin had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Dr Lechtzin: contributed to the study conception and design; data acquisition, analysis, and interpretation; drafting of the manuscript; critical revision of the manuscript for important intellectual content; and approval of the final version.
Dr Hilliard: contributed to the study conception and design; data acquisition,
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Funding/Support: The Celgene Corporation provided support for the initial clinical trial from which these data were obtained.
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