Forced vital capacity in patients with idiopathic pulmonary fibrosis: Test properties and minimal clinically important difference

American Journal of Respiratory and Critical Care Medicine

Volumn 184, Issue 12, 2011, Pages 1382-1389

  Du Bois, Roland M ^a   Weycker, Derek ^b   Albera, Carlo ^c   Bradford, Williamson Z ^d   Costabel, Ulrich ^e   Kartashov, Alex ^b   King Jr , Talmadge E ^f   Lancaster, Lisa ^g   Noble, Paul W ^h   Sahn, Steven A ⁱ   Thomeer, Michiel ^j   Valeyre, Dominique ^k   Wells, Athol U ^l  

^a IMPERIAL COLLEGE LONDON   (United Kingdom)

^b POLICY ANALYSIS INC PAI   (United States)

^c UNIVERSITY OF TURIN   (Italy)

^d InterMune Inc   (United States)

^e UNIVERSITY OF DUISBURG ESSEN   (Germany)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^h DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^j UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^k AVICENNE HOSPITAL   (France)

^l ROYAL BROMPTON HOSPITAL   (United Kingdom)

more..

Author keywords

Forced vital capacity; Idiopathic pulmonary fibrosis; Interstitial lung disease; Minimal clinically important difference; Mortality prediction

Indexed keywords

CARBON MONOXIDE; GAMMA1B INTERFERON; PLACEBO;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; FEMALE; FIBROSING ALVEOLITIS; FORCED VITAL CAPACITY; FUNCTIONAL STATUS; HUMAN; LUNG DIFFUSION CAPACITY; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; MEASUREMENT; MINIMAL CLINICALLY IMPORTANT DIFFERENCE; MORTALITY; OUTCOME ASSESSMENT; PREDICTOR VARIABLE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RELIABILITY; RISK FACTOR; SCREENING TEST; VALIDITY;

AGED; FEMALE; HUMANS; IDIOPATHIC PULMONARY FIBROSIS; MALE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; PROGNOSIS; REPRODUCIBILITY OF RESULTS; VITAL CAPACITY;

EID: 84455168726     PISSN: 1073449X     EISSN: 15354970     Source Type: Journal    
DOI: 10.1164/rccm.201105-0840OC     Document Type: Article

References (32)

1. King TE Jr, Tooze JA, Schwarz MI, Brown K, Cherniack RM. Predicting survival in idiopathic pulmonary fibrosis. Scoring system and survival model. Am J Respir Crit Care Med 2001;164:1171-1181. (Pubitemid 33052246)
2. Latsi PI, du Bois RM, Nicholson AG, Colby TV, Bisirtzoglou D, Nikolakopoulou A, Veeraraghavan S, Hansell DM, Wells AU. Fibrotic idiopathic interstitial pneumonia: the prognostic value of longitudinal functional trends. Am J Respir Crit Care Med 2003;168: 531-537. (Pubitemid 37088594)
3. Ley B, Collard HR, King TE Jr. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2011;183:431-440.
4. American Thoracic Society, European Respiratory Society. Idiopathic pulmonary fibrosis: diagnosis and treatment. International consensus statement. Am J Respir Crit Care Med 2000;161:646-664.
5. Azuma A, Nukiwa T, Tsuboi E, Suga M, Abe S, Nakata K, Taguchi Y, Nagai S, Itoh H, Ohi M, et al. Double-blind, placebo-controlled, trial of pirfenidone in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2005;171:1040-1047. (Pubitemid 40616955)
6. Demedts M, Behr J, Buhl R, Costabel U, Dekhuijzen R, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, et al. High-dose acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med 2005; 353:2229-2242. (Pubitemid 41697286)
7. Taniguchi H, Ebina M, Kondoh Y, Azuma A, Ogura T, Taguchi Y, Suga M, Takahashi H, Nakata K, Sato A, et al. Pirfenidone in idiopathic pulmonary fibrosis: a phase III clinical trial in Japan. Eur Respir J 2010;35:821-829.
8. Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, King TE Jr, Lancaster L, Sahn SA, Szwarcberg J, et al. The CAPACITY Program: two randomised, double-blind, placebo controlled trials of pirfenidone in patients with idiopathic pulmonary fibrosis. Lancet 2011;377:1760-1769.
9. Collard HR, King TE Jr, Bartelson BB, Vourlekis JS, Schwarz MI, Brown KK. Changes in clinical and physiologic variables predict survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2003;168:538-542. (Pubitemid 37088595)
10. Flaherty KR, Mumford JA, Murray S, Kazerooni EA, Gross BH, Colby TV, Travis WD, Flint A, Toews GB, Lynch JP, et al. Prognostic implications of physiologic and radiographic changes in idiopathic interstitial pneumonia. Am J Respir Crit Care Med 2003; 168:543-548. (Pubitemid 37088596)
11. Jegal Y, Kim DS, Shim TS, Lim CM, Do Lee S, Koh Y, Kim WS, Kim WD, Lee JS, Travis WD, et al. Physiology is a stronger predictor of survival than pathology in fibrotic interstitial pneumonia. Am J Respir Crit Care Med 2005;171:639-644. (Pubitemid 40365421)
12. King TE Jr, Safrin S, Starko KM, Brown KK, Noble PW, Raghu G, Schwartz DA. Analyses of efficacy end points in a controlled trial of interferon gamma-1b for idiopathic pulmonary fibrosis. Chest 2005; 127:171-177. (Pubitemid 41724573)
13. Zappala CJ, Latsi PI, Nicholson AG, Colby TV, Cramer D, Renzoni EA, Hansell DM, du Bois RM, Wells AU. Marginal decline in FVC is associated with a poor outcome in idiopathic pulmonary fibrosis. Eur Respir J 2009;35:830-836.
14. du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, Lancaster L, Noble PW, Raghu G, Sahn SA, et al. Ascertainment of individual risk of mortality for patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2011;184: 459-466.
15. Guyatt GH, Osoba D, Wu AW, Wyrich KW, Norman GR. Methods to explain the clinical significance of health measures. Mayo Clin Proc 2002;77:371-383. (Pubitemid 34260746)
16. Holland AE, Hill CJ, Conron M, Munro P, McDonald CF. Small changes in six-minute walk distance are important in diffuse parenchymal lung disease. Respir Med 2009;103:1430-1435.
17. Man-Son-Hing M, Laupacis A, O'Rourke K, Molnar FJ, Mahon J, Chan KB, Wells G. Determination of the clinical importance of study results. J Gen Intern Med 2002;17:469-476. (Pubitemid 34989015)
18. Schunemann HJ, Guyatt GH. Commentary-goodbye M(C)ID! hello MID, where do you come from? Health Serv Res 2005;40: 593-597. (Pubitemid 40470710)
19. du Bois RM, Albera C, Bradford WZ, Costabel U, Kartashov A, Noble PW, Szwarcberg J, Thomeer M, Valeyre D, Weycker D, et al. Percent predicted forced vital capacity is a reliable, valid, and responsive measure of clinical status in patients with idiopathic pulmonary fibrosis [abstract]. European Respiratory Society Annual Congress 2010. Barcelona, Spain, September 18-22. A3632.
20. Raghu G, Brown KK, Bradford WZ, Starko K, Noble PW, Schwartz DA, King TE Jr. A placebo-controlled trial of interferon gamma-1b in patients with idiopathic pulmonary fibrosis. N Engl J Med 2004;350: 125-133. (Pubitemid 38056223)
21. King TE Jr, Albera C, BradfordWZ, Costabel U, Hormel P, Lancaster L, Noble PW, Sahn SA, Szwarcberg J, Thomeer M, et al. Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE): a multicentre, randomised, placebo-controlled trial. Lancet 2009;374:222-228.
22. Eakin EG, Resnikoff PM, Prewitt LM, Ries AL, Kaplan RM. Validation of a new dyspnoea measure: the UCSD shortness of breath questionnaire. University of California, San Diego. Chest 1998;113: 619-624. (Pubitemid 28130933)
23. Chang JA, Curtis JR, Patrick DL, Raghu G. Assessment of health-related quality of life in patients with interstitial lung disease. Chest 1999;116:1175-1182. (Pubitemid 29535966)
24. Cohen J. Statistical power analysis for behavioral sciences, 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.
25. Allison PD. Survival analysis using the SAS System: a practical guide. Cary, NC: SAS Institute Inc., 1995. pp. 292.
26. Wyrwich KW, Nienaber NA, Tierney WM, Wolinsky FD. Linking clinical relevance and statistical significance in evaluating intraindividual changes in health-related quality of life. Med Care 1999; 37:469-478.
27. Wyrwich KW, Tierney WM, Wolinsky FD. Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol 1999;52: 861-873. (Pubitemid 29385600)
28. Ries AL. Minimally clinically important difference for the UCSD Shortness of Breath Questionnaire, Borg Scale, and Visual Analog Scale. COPD 2005;2:105-110. (Pubitemid 40776230)
29. Nichol MB, Epstein JD. Separating gains and losses in health when calculating the minimum important difference for mapped utility values. Qual Life Res 2008;17:955-961.
30. Yost KJ, Eton DT. Combining distribution- and anchor-based approaches to determine minimally important differences. Eval Health Prof 2005;28:172-191 (Pubitemid 40628906)
31. Walters SJ, Brazier JE. What is the relationship between the minimally important difference and health state utility values? The case of the SF-6D. Health Qual Life Outcomes 2003;1:4.
32. du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, Lancaster L, Noble PW, Sahn SA, Szwarcberg J, et al. Six-minute walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference. Am J Respir Crit Care Med 2011;183:1231-1237.