Content validity of CASA-Q cough domains and UCSD-SOBQ for use in patients with Idiopathic Pulmonary Fibrosis

Katharine Suzanne Gries, Dirk Esser, Ingela Wiklund, Katharine Suzanne Gries, Dirk Esser, Ingela Wiklund

Abstract

Purpose: The study objective was to assess the content validity of the Cough and Sputum Assessment Questionnaire (CASA-Q) cough domains and the UCSD Shortness of Breath Questionnaire (SOBQ) for use in patients with Idiopathic Pulmonary Fibrosis (IPF).

Methods: Cross-sectional, qualitative study with cognitive interviews in patients with IPF. Study outcomes included relevance, comprehension of item meaning, understanding of the instructions, recall period, response options, and concept saturation.

Results: Interviews were conducted with 18 IPF patients. The mean age was 68.9 years (SD 11.9), 77.8% were male, and 88.9% were Caucasian. The intended meaning of the CASA-Q cough domain items was clearly understood by most of the participants (89-100%). All participants understood the CASA-Q instructions; the correct recall period was reported by 89% of the patients, and the response options were understood by 76%. The intended meaning of the UCSD-SOBQ items was relevant and clearly understood by all participants. Participants understood the instructions (83%) and all patients understood the response options (100%). The reported recall period varied based on the type of activity performed. No concepts were missing, suggesting that saturation was demonstrated for both measures.

Conclusions: This study provides evidence for content validity for the CASA-Q cough domains and the UCSD-SOBQ for patients with IPF. Items of both questionnaires were understood and perceived as relevant to measure the key symptoms of IPF. The results of this study support the use of these instruments in IPF clinical trials as well as further studies of their psychometric properties.

Figures

Figure 1
Figure 1
Participants’ ability to understand and explain the meaning of each CASA-Q item (n=18)
Figure 2
Figure 2
Participants who reported the CASA-Q item was relevant for their IPF experience (n=18)
Figure 3
Figure 3
Participants’ ability to understand and explain the meaning of each UCSD-SOBQ item (n=18)
Figure 4
Figure 4
Participants who reported the UCSD-SOBQ item was relevant for their IPF experience (n=18)

References

    1. American Thoracic Society. Idiopathic pulmonary fibrosis: Diagnosis and treatment. International consensus statement. American Thoracic Society (ATS), and the European Respiratory Society (ERS) Am J Respir Crit Care Med. 2000;161(2):646–664.
    1. Baumgartner K. B, Samet J. M, Stidley C. A, Colby T. V, Waldron J. A. Cigarette smoking: A risk factor for idiopathic fulmonary fibrosis. Am J Respir Crit Care Med. 1997;155(1):242–248.
    1. Birring S. S, Prudon B, Carr A. J, Singh S. J, Morgan M. D, Pavord I. D. Development of a symptom specific health status measure for patients with chronic cough: Leicester cough questionnaire (LCQ) Thorax. 2003;58(4):339–343.
    1. Crawford B, Monz B, Hohlfeld J, Roche N, Rubin B, Magnussen H, Tetzlaff K. Development and validation of a cough and sputum assessment questionnaire. Respir Med. 2008;102(11):1545–1555. .
    1. Eakin E. G, Resnikoff P. M, Prewitt L. M, Ries A. L, Kaplan R. M. Validation of a new dyspnea measure: The UCSD shortness of breath questionnaire. University of California, San Diego. Chest. 1998;113(3):619–624.
    1. Fabbri L. M, Calverley P. M, Izquierdo-Alonso J. L, Bundschuh D. S, Brose M, Martinez F. J, Rabe K. F. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: Two randomised clinical trials. Lancet. 2009;374(9691):695–703. .
    1. Food and Drug Administration. Guidance for industry patient-reported outcome measures: Use in medical product development to support labeling claims. 2009
    1. French C. T, Irwin R. S, Fletcher K. E, Adams T. M. Evaluation of a cough-specific quality-of-life questionnaire. Chest. 2002;121(4):1123–1131.
    1. Giardino N. D, Curtis J. L, Andrei A. C, Fan V. S, Benditt J. O, Lyubkin M. Anxiety is associated with diminished exercise performance and quality of life in severe emphysema: A cross-sectional study. Respir Res. 2010;11:29. Nett Research Group. .
    1. Gribbin J, Hubbard R, Smith C. Role of diabetes mellitus and gastro-oesophageal reflux in the aetiology of idiopathic pulmonary fibrosis. Respir Med. 2009;103(6):927–931.
    1. Kupferberg D, Kaplan R. M, Slymen D. J, Ries A. L. Minimal clinically important difference for the UCSD shortness of breath questionnaire. J Cardiopulm Rehabil. 2005;24:370–377.
    1. Lechtzin N, Hilliard M. E, Horton M. R. Validation of the cough quality of life questionnaire in patients with idiopathic pulmonary fibrosis. Chest. 2013. .
    1. Martinez T. Y, Pereira C. A. C, dos Santos M. L, Ciconelli R. M, Guimaraes S. M, Martinez J. A. B. Evaluation of the short-form 36-item questionnaire to measure health-related quality of life in patients with idiopathic pulmonary fibrosis. Chest. 2000;117:1627–1632.
    1. Meek P. M, Lareau S. C. Critical outcomes in pulmonary rehabilitation: Assessment and evaluation of dyspnea and fatigue. J Rehabil Res Dev. 2003;40(5 Suppl 2):13–24.
    1. Monz B. U, Sachs P, McDonald J, Crawford B, Nivens M. C, Tetzlaff K. Responsiveness of the cough and sputum assessment questionnaire in exacerbations of COPD and chronic bronchitis. Respir Med. 2010;104(4):534–541. .
    1. Muhr T. User’s manual for atlas. Ti 5.0. Berlin: Scientific Development GmbH; 2004.
    1. Noble P. W, Albera C, Bradford W. Z, Costabel U, Glassberg M, Kardatzke D, du Bois R. M. Pirfenidone in patient with idiopathic pulmonary fibrosis (capacity): Two randomised trials. Lancet. 2011;377:1760–1769.
    1. Patel A. S, Siegert R. J, Brignall K, Gordon P, Steer S, Desai S. R, Birring S. S. The development and validation of the King’s Brief Interstitial Lung Disease (K-BILD) health status questionnaire. Thorax. 2012;67(9):804–810. .
    1. Patrick D. L, Burke L. B, Gwaltney C. J, Leidy N. K, Martin M. L, Molsen E, Ring L. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR pro good research practices task force report: Part 2--assessing respondent understanding. Value Health. 2011a;14(8):978–988. .
    1. Patrick D. L, Burke L. B, Gwaltney C. J, Leidy N. K, Martin M. L, Molsen E, Ring L. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR pro good research practices task force report: Part 1--eliciting concepts for a new pro instrument. Value Health. 2011b;14(8):967–977. .
    1. Raghu G, Collard H.R, Egan J.J, Martinez F.J, Behr J, Brown K.K, Schunemann H.J. An official ats/ers/jrs/alat committee on idiopathic pulmonary fibrosis. Am J Respir Care Med. 2011;183(6):788–824.
    1. Ries A. L. Impact of chronic obstructive pulmonary disease on quality of life: The role of dyspnea. Am J Med. 2006;119(10 Suppl 1):12–20. .
    1. Swigris J. J, Fairclough D. Patient-reported outcomes in idiopathic pulmonary fibrosis research. Chest. 2012;142(2):291–297. .
    1. Swigris J. J, Han M, Vij R, Noth I, Eisenstein E. L, Anstrom K. J, Fairclough D. The UCSD shortness of breath questionnaire has longitudinal construct validity in idiopathic pulmonary fibrosis. Respir Med. 2012;106(10):1447–1455. .
    1. Swigris J. J, Kuschner W. G, Jacobs S. S, Wilson S. R, Gould M. K. Health-related quality of life in patients with idiopathic pulmonary fibrosis: A systematic review. Thorax. 2005;60(7):588–594. .
    1. Swigris J. J, Stewart A. L, Gould M. K, Wilson S. R. Patients’ perspectives on how idiopathic pulmonary fibrosis affects the quality of their lives. Health Qual Life Outcomes. 2005;3:61. .
    1. Swigris J. J, Wilson S. R, Green K. E, Sprunger D. B, Brown K. K, Wamboldt F. S. Development of the ATAQ-IPF: A tool to assess quality of life in IPF. Health Qual Life Outcomes. 2010;8:77. .
    1. Taskar V. S, Coultas D. B. Is idiopathic pulmonary fibrosis an environmental disease? Proc Am Thorac Soc. 2006;3(4):293–298.
    1. Tzilas V, Koti A, Papandrinopoulou D, Tsoukalas G. Prognostic factors in idiopathic pulmonary fibrosis. Am J Med Sci. 2009;338(6):481–485.
    1. Verrill D, Barton C, Beasley W, Lippard W. M. The effects of short-term and long-term pulmonary rehabilitation on functional capacity, perceived dyspnea, and quality of life. Chest. 2005;128(2):673–683. .
    1. Wild D, Eremenco S, Mear I, Martin M, Houchin C, Gawlicki M, Molsen E. Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: The ISPOR patient-reported outcomes translation and linguistic validation good research practices task force report. Value Health. 2009;12(4):430–440. .
    1. Yorke J, Jones P. W, Swigris J. J. Development and validity testing of an IPF-specific version of the St. George’s respiratory questionnaire. Thorax. 2010;65(10):921–926. .

Source: PubMed

3
Tilaa