Validation of the IPF-specific version of St. George's Respiratory Questionnaire

Thomas Skovhus Prior, Nils Hoyer, Saher Burhan Shaker, Jesper Rømhild Davidsen, Janelle Yorke, Ole Hilberg, Elisabeth Bendstrup, Thomas Skovhus Prior, Nils Hoyer, Saher Burhan Shaker, Jesper Rømhild Davidsen, Janelle Yorke, Ole Hilberg, Elisabeth Bendstrup

Abstract

Background: Patients with idiopathic pulmonary fibrosis (IPF) have impaired health-related quality of life (HRQL). To measure HRQL, an IPF-specific version of the St. George's Respiratory Questionnaire (SGRQ-I) was developed, but not sufficiently validated. This study aimed to assess the validity (i.a. known-groups validity and concurrent validity) and test-retest reliability of SGRQ-I in IPF patients with different disease durations.

Methods: Patients with IPF were consecutively recruited and completed SGRQ, SGRQ-I, King's Brief Interstitial Lung Disease questionnaire (K-BILD), University of California, San Diego Shortness of Breath Questionnaire (SOBQ) and Short Form-36 (SF-36) along with pulmonary function tests and a 6-min walk test (6MWT) at baseline. After two weeks, SGRQ-I and Global Rating of Change Scales (GRCS) were completed.

Results: At baseline and after two weeks, 150 and 134 patients completed the questionnaires, respectively. The internal consistency of SGRQ-I was high (Cronbach's α = 0.92). Good concurrent validity was demonstrated by high intraclass correlation coefficients (ICC = 0.97), Bland-Altman plots and moderate to strong correlations to K-BILD, SOBQ and SF-36 (r = - 0.46 to 0.80). High ICC (0.92) and a Bland-Altman plot indicated good test-retest reliability. SGRQ-I was good at discriminating between patients with different stages of disease (Δscore > 18.1, effect sizes > 0.10). Validity was similar across groups of different disease duration.

Conclusions: SGRQ-I proved to be valid at distinguishing between different disease severities, valid compared to other HRQL instruments, applicable across different disease durations and reliable upon repetition. SGRQ-I is a valid option for measuring HRQL in patients with IPF.

Trial registration: The study was registered at clinicaltrials.org ( NCT02818712 ) on 15 June 2016.

Keywords: Health-related quality of life; IPF-specific version of the St. George’s respiratory questionnaire; Idiopathic pulmonary fibrosis; Interstitial lung disease; K-BILD; Quality of life; SGRQ; SGRQ-I.

Conflict of interest statement

JY developed the SGRQ-I and has nothing else to disclose. TSP, OH and EB have received an unrestricted grant from Boehringer Ingelheim for the current work. Outside the current work, TSP reports personal fees from Boehringer Ingelheim and Roche, NH reports and unrestricted grant from Roche, SBS reports personal fees from Boehringer Ingelheim, Roche and AstraZeneca, JRD reports an unrestricted grant from Boehringer Ingelheim and an unrestricted grant and personal fees from Roche, OH reports an unrestricted grant from Roche and an unrestricted grant and personal fees from Boehringer Ingelheim, EB reports unrestricted grants and personal fees from Boehringer Ingelheim, Roche, Novartis and AstraZeneca.

Figures

Fig. 1
Fig. 1
Bland-Altman plot of the agreement between SGRQ-I and SGRQ for all patients. The solid line is the mean difference, while the dashed lines are the 95% limits of agreement. SGRQ-I: IPF-specific version of the St. George’s Respiratory Questionnaire; SGRQ: St. George’s Respiratory Questionnaire
Fig. 2
Fig. 2
Bland-Altman plot of the repeatability of SGRQ-I in all stable patients. The solid line is the mean difference, while the dashed lines are the 95% limits of agreement. SGRQ-I: IPF-specific version of the St. George’s Respiratory Questionnaire
Fig. 3
Fig. 3
SGRQ-I total score in (a) the lower and upper quartile of FVC % predicted, (b) the lower and upper quartile of DLCO % predicted, (c) long-term oxygen therapy and (d) GAP index. The midlines in the boxes are the median values and the boundaries are the 25th and 75th percentiles; the whiskers are the upper adjacent values (1.5 interquartile range above the 75th percentile) and lower adjacent values (1.5 interquartile range below the 25th percentile). The dots are outlying values. SGRQ-I: IPF-specific version of the St. George’s Respiratory Questionnaire. FVC: Forced vital capacity; DLCO: Diffusing capacity of the lung for carbon monoxide; LTOT: Long-term oxygen therapy; GAP: Gender, age, physiology

References

    1. Raghu G, Chen S-Y, Yeh W-S, Maroni B, Li Q, Lee Y-C, et al. Idiopathic pulmonary fibrosis in US Medicare beneficiaries aged 65 years and older: incidence, prevalence, and survival, 2001–11. Lancet Respir Med [Internet]. 2014;2600(14):1–7. Available from: .
    1. Belkin A, Swigris JJ. Health-related quality of life in idiopathic pulmonary fibrosis: where are we now? Curr Opin Pulm Med [Internet]. 2013 Sep [cited 2015 Nov 29];19(5):474–479. Available from: .
    1. Richeldi L, Cottin V, du Bois RM, Selman M, Kimura T, Bailes Z, et al. Nintedanib in patients with idiopathic pulmonary fibrosis: combined evidence from the TOMORROW and INPULSIS® trials. Respir Med [Internet] 2016; Available from: .
    1. Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet (London, England) [Internet] 2011 May 21 [cited 2016 Feb 21];377(9779):1760–1769. Available from: .
    1. Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med [Internet]. 1993 Apr 15 [cited 2015 Oct 15];118(8):622–629. Available from: .
    1. King Talmadge E., Bradford Williamson Z., Castro-Bernardini Socorro, Fagan Elizabeth A., Glaspole Ian, Glassberg Marilyn K., Gorina Eduard, Hopkins Peter M., Kardatzke David, Lancaster Lisa, Lederer David J., Nathan Steven D., Pereira Carlos A., Sahn Steven A., Sussman Robert, Swigris Jeffrey J., Noble Paul W. A Phase 3 Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. New England Journal of Medicine. 2014;370(22):2083–2092. doi: 10.1056/NEJMoa1402582.
    1. Swigris JJ, Esser D, Conoscenti CS, Brown KK. The psychometric properties of the St George’s respiratory questionnaire (SGRQ) in patients with idiopathic pulmonary fibrosis: a literature review. Health Qual Life Outcomes [Internet] 2014;12(1):124. Available from: .
    1. Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George’s respiratory questionnaire. Am Rev Respir Dis [Internet]. 1992 Jun [cited 2018 Jun 8];145(6):1321–1327. Available from: .
    1. Yorke J, Jones PW, Swigris JJ. Development and validity testing of an IPF-specific version of the St George’s respiratory questionnaire. Thorax [Internet]. 2010;65(10):921–926. Available from: .
    1. Swigris JJ, Han M, Vij R, Noth I, Eisenstein EL, Anstrom KJ, et al. The UCSD shortness of breath questionnaire has longitudinal construct validity in idiopathic pulmonary fibrosis. Respir Med [Internet]. 2012 Oct [cited 2015 Dec 15];106(10):1447–1455. Available from: .
    1. Gries KS, Esser D, Wiklund I. Content validity of CASA-Q cough domains and UCSD-SOBQ for use in patients with Idiopathic Pulmonary Fibrosis. Glob J Health Sci [Internet]. 2013 Nov [cited 2016 Mar 7];5(6):131–141. Available from:
    1. Patel Amit S, Siegert Richard J, Brignall Katherine, Gordon Patrick, Steer Sophia, Desai Sujal R, Maher Toby M, Renzoni Elisabetta A, Wells Athol U, Higginson Irene J, Birring Surinder S. The development and validation of the King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire. Thorax. 2012;67(9):804–810. doi: 10.1136/thoraxjnl-2012-201581.
    1. Capparelli I, Fernandez M, Saadia Otero M, Steimberg J, Brassesco M, Campobasso A, et al. Traducción al español y validación del cuestionario Saint George específico para fibrosis pulmonar idiopática. Arch Bronconeumol [Internet]. 2018 Nov 1 [cited 2017 Nov 9];54(2):68–73. Available from: .
    1. WHO | WHO Definition of Palliative Care. WHO [Internet]. 2012 [cited 2018 Oct 16]; Available from: .
    1. Kreuter Michael, Bendstrup Elisabeth, Russell Anne-Marie, Bajwah Sabrina, Lindell Kathleen, Adir Yochai, Brown Crystal E, Calligaro Greg, Cassidy Nicola, Corte Tamera J, Geissler Klaus, Hassan Azza Adel, Johannson Kerri A, Kairalla Ronaldo, Kolb Martin, Kondoh Yasuhiro, Quadrelli Sylvia, Swigris Jeff, Udwadia Zarir, Wells Athol, Wijsenbeek Marlies. Palliative care in interstitial lung disease: living well. The Lancet Respiratory Medicine. 2017;5(12):968–980. doi: 10.1016/S2213-2600(17)30383-1.
    1. Beaton DE, Bombardier C, Guillemin F, Ferraz MB, D.E. B, C. B, et al. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976) [Internet]. 2000 Dec;25(24):3186–3191. Available from: .
    1. Wild Diane, Grove Alyson, Martin Mona, Eremenco Sonya, McElroy Sandra, Verjee-Lorenz Aneesa, Erikson Pennifer. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation. Value in Health. 2005;8(2):94–104. doi: 10.1111/j.1524-4733.2005.04054.x.
    1. Wells AU, Hirani N, Egan JJ, Greaves MS, Hansell DM, Harrison NK, et al. Interstitial lung disease guideline: the British Thoracic Society in collaboration with the Thoracic Society of Australia and new Zealand and the Irish thoracic society. Thorax [Internet] 2008 Sep 1 [cited 2019 Mar 29];63(Supplement 5):v1–58. Available from: .
    1. Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, et al. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med [Internet]. 2011 Mar 15 [cited 2019 Feb 19];183(6):788–824. Available from: .
    1. Ley Brett, Ryerson Christopher J., Vittinghoff Eric, Ryu Jay H., Tomassetti Sara, Lee Joyce S., Poletti Venerino, Buccioli Matteo, Elicker Brett M., Jones Kirk D., King Talmadge E., Collard Harold R. A Multidimensional Index and Staging System for Idiopathic Pulmonary Fibrosis. Annals of Internal Medicine. 2012;156(10):684. doi: 10.7326/0003-4819-156-10-201205150-00004.
    1. Eakin EG, Resnikoff PM, Prewitt LM, Ries AL, Kaplan RM. Validation of a new dyspnea measure: the UCSD Shortness of Breath Questionnaire. University of California, San Diego. Chest [Internet]. 1998 Mar [cited 2016 Jan 9];113(3):619–624. Available from: .
    1. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care [Internet]. 1992 Jun [cited 2014 Jul 17];30(6):473–483. Available from: .
    1. Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther [Internet] 2009;17(3):163–170. doi: 10.1179/jmt.2009.17.3.163.
    1. Swigris Jeffrey J, Wilson Hilary, Esser Dirk, Conoscenti Craig S, Stansen Wibke, Kline Leidy Nancy, Brown Kevin K. Psychometric properties of the St George’s Respiratory Questionnaire in patients with idiopathic pulmonary fibrosis: insights from the INPULSIS trials. BMJ Open Respiratory Research. 2018;5(1):e000278. doi: 10.1136/bmjresp-2018-000278.
    1. Terwee CB, Bot SDM, de Boer MR, van der Windt DAWM, Knol DL, Dekker J, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60(1):34–42. doi: 10.1016/j.jclinepi.2006.03.012.
    1. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed: Lawrence Erlbaum Associates; 1988.
    1. McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res [Internet]. 1995 Aug [cited 2019 Aug 5];4(4):293–307. Available from: .
    1. Tzanakis Nikolaos, Samiou Maria, Lambiri Irini, Antoniou Katerina, Siafakas Nikolaos, Bouros Demosthenes. Evaluation of health-related quality-of-life and dyspnea scales in patients with idiopathic pulmonary fibrosis. Correlation with pulmonary function tests. European Journal of Internal Medicine. 2005;16(2):105–112. doi: 10.1016/j.ejim.2004.09.013.
    1. Swigris JJ, Wilson SR, Green KE, Sprunger DB, Brown KK, Wamboldt FS. Development of the ATAQ-IPF: a tool to assess quality of life in IPF. rcj [Internet]. 2010 Jan [cited 2015 Dec 18];8:77. Available from: .
    1. Matsuda Toshiaki, Taniguchi Hiroyuki, Ando Masahiko, Kondoh Yasuhiro, Kimura Tomoki, Kataoka Kensuke, Sakamoto Koji, Suzuki Atsushi, Furukawa Taiki, Hasegawa Yoshinori. COPD Assessment Test for measurement of health status in patients with idiopathic pulmonary fibrosis: A cross-sectional study. Respirology. 2016;22(4):721–727. doi: 10.1111/resp.12936.
    1. NAGATA KAZUMA, TOMII KEISUKE, OTSUKA KOJIRO, TACHIKAWA RYO, OTSUKA KYOKO, TAKESHITA JUNPEI, TANAKA KOSUKE, MATSUMOTO TAKESHI, MONDEN KAZUYA. Evaluation of the chronic obstructive pulmonary disease assessment test for measurement of health-related quality of life in patients with interstitial lung disease. Respirology. 2012;17(3):506–512. doi: 10.1111/j.1440-1843.2012.02131.x.
    1. Grufstedt Heidi Kjeldgaard, Shaker Saher Burhan, Konradsen Hanne. Validation of the COPD Assessment Test (CAT) in patients with idiopathic pulmonary fibrosis. European Clinical Respiratory Journal. 2018;5(1):1530028. doi: 10.1080/20018525.2018.1530028.

Source: PubMed

3
Sottoscrivi