The idiopathic pulmonary fibrosis clinical research network (IPFnet)

Diagnostic and adjudication processes

Joao De Andrade, Marvin Schwarz, Harold R. Collard, Tedryl Gentry-Bumpass, Thomas Colby, David Lynch, Robert J. Kaner, M. Schwarz, D. A. Zisman, J. Chapman, M. Olman, S. Lubell, L. D. Morrison, M. P. Steele, T. Haram, J. Roman, R. Perez, T. Perez, J. H. Ryu, J. P. Utz & 335 others A. H. Limper, C. E. Daniels, K. Meiras, S. Walsh, K. K. Brown, M. Schwarz, C. Bair, D. Kervitsky, J. A. Lasky, S. Ditta, J. DeAndrade, V. J. Thannickal, M. Stewart, D. A. Zisman, J. Lynch, E. Calahan, P. Lopez, T. E. King, H. R. Collard, J. A. Golden, P. J. Wolters, R. Jeffrey, I. Noth, D. K. Hogarth, N. Sandbo, M. E. Strek, S. R. White, C. Brown, I. Garic, S. Maleckar, F. J. Martinez, K. R. Flaherty, M. Han, B. Moore, G. B. Toews, D. Dahlgren, G. Raghu, J. Hayes, M. Snyder, J. E. Loyd, L. Lancaster, W. Lawson, R. Greer, W. Mason, R. J. Kaner, V. Monroy, M. Wang, D. A. Lynch, K. J. Anstrom, R. C. Becker, E. L. Eisenstein, N. R. MacIntyre, L. D. Morrison, J. Rochon, M. P. Steele, J. S. Sundy, L. Davidson-Ray, P. Dignacco, R. Edwards, R. Anderson, R. Beci, S. Calvert, K. Cain, T. Gentry-Bumpass, D. Hill, M. Ingham, E. Kagan, J. Kaur, C. Matti, J. McClelland, A. Meredith, T. Nguyen, J. Pesarchick, R. S. Roberts, W. Tate, T. Thomas, J. Walker, D. Whelan, J. Winsor, Q. Yang, E. Yow, H. Y. Reynolds, X. Tian, J. Kiley, M. Olman, G. B. Toews, G. Hunninghake, D. A. Culver, J. Chapman, M. Olman, S. Lubell, R. Wehrmann, L. D. Morrison, M. P. Steele, T. Haram, R. Kidd, M. Kallay, E. Lyda, J. H. Ryu, J. P. Utz, A. H. Limper, C. E. Daniels, K. Meiras, S. Walsh, S. Sahn, N. O'Banner, F. Stokes, K. K. Brown, C. Bair, D. Kervitsky, N. A. Ettinger, S. Merli, J. De Andrade, V. J. Thannickal, M. Stewart, J. Belperio, J. P. Lynch, E. Calahan, P. Lopez, T. E. King, H. R. Collard, J. Golden, P. Wolters, A. Eller, I. Noth, D. K. Hogarth, N. Sandbo, M. E. Strek, S. Maleckar, G. Rahimova, L. Sardin, J. Roman, R. Perez, T. Perez, M. Glassberg, E. Simonet, F. J. Martinez, K. Baumann, K. Chan, A. Chughtai, B. Gross, K. R. Flaherty, M. L. Han, R. Hyzy, E. Kazerooni, B. Moore, J. Myers, G. B. Toews, E. White, D. Dahlgren, M. Rossman, M. Kreider, K. Le, J. Fitzgerald, C. Glazer, M. B. Scholand, L. Brewster, A. Johnson, G. Raghu, P. Berry-Bell, A. Snydsman, J. E. Loyd, L. Lancaster, W. Lawson, R. Greer, K. Kinser, R. Richardson, W. Mason, R. J. Kaner, K. Bandong, D. Antin-Ozerkis, C. Holm, J. Estrom, D. A. Lynch, T. Colby, K. J. Anstrom, E. L. Eisenstein, J. S. Sundy, L. Davidson-Ray, P. Dignacco, R. Edwards, R. Beci, S. Calvert, T. Gentry-Bumpass, D. Hill, P. V. Hofmann, K. Hwang, J. Kaur, C. Matti, A. Meredith, J. Pesarchick, S. Ramey, R. S. Roberts, A. Sharlow, J. Winsor, Q. Yang, E. Yow, G. G. Weinmann, H. Reynolds, B. Schmetter, X. Tian, J. Kiley, F. J. Martinez, G. Raghu, M. Schwarz, G. B. Toews, J. Zibrak, A. Demersky, M. Vey, I. O. Rosas, P. Debrosse, D. A. Culver, J. Chapman, M. Olman, S. Lubell, R. Wehrmann, L. D. Morrison, M. P. Steele, T. Haram, R. Kidd, M. Kallay, E. Lyda, J. H. Ryu, J. P. Utz, A. H. Limper, C. E. Daniels, K. Meiras, S. Walsh, S. Sahn, N. O'Banner, F. Stokes, M. Padilla, G. Berhanu, K. K. Brown, C. Bair, D. Kervitsky, N. A. Ettinger, S. Merli, G. J. Criner, I. Q. Swift, A. Satti, F. Cordova, N. Patel, K. West, G. Jones, J. A. Lasky, S. Ditta, J. De Andrade, V. J. Thannickal, M. Stewart, J. Belperio, J. P. Lynch, E. Calahan, P. Lopez, T. E. King, H. R. Collard, J. Golden, P. Wolters, A. Eller, I. Noth, D. K. Hogarth, N. Sandbo, M. E. Strek, S. Maleckar, G. Rahimova, L. Sardin, J. Roman, R. Perez, T. Perez, M. Glassberg, E. Simonet, F. J. Martinez, K. Baumann, K. Chan, A. Chughtai, B. Gross, K. R. Flaherty, M. L. Han, R. Hyzy, E. Kazerooni, B. Moore, J. Myers, G. B. Toews, E. White, D. Dahlgren, M. Rossman, M. Kreider, K. Le, J. Fitzgerald, C. Glazer, M. B. Scholand, L. Brewster, A. Johnson, G. Raghu, P. Berry-Bell, A. Snydsman, J. E. Loyd, L. Lancaster, W. Lawson, R. Greer, W. Mason, R. J. Kaner, K. Bandong, D. Antin-Ozerkis, C. Holm, J. Estrom, D. A. Lynch, T. Colby, K. J. Anstrom, R. C. Becker, E. L. Eisenstein, J. S. Sundy, L. Davidson-Ray, P. Dignacco, R. Edwards, R. Beci, S. Calvert, K. Cain, T. Gentry-Bumpass, D. Hill, K. Huang, J. Kaur, C. Matti, A. Meredith, J. Pesarchick, S. Ramey, R. S. Roberts, A. Sharlow, J. Winsor, E. Yow, G. G. Weinmann, H. Reynolds, B. Schmetter, X. Tian, J. Kiley

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Background: The National Heart, Lung, and Blood Institute-sponsored IPF Clinical Research Network (IPFnet) studies enrolled subjects with idiopathic pulmonary fibrosis (IPF) to evaluate drug therapies in treatment trials. An adjudication committee (AC) provided a structured review of cases in which there was uncertainty or disagreement regarding diagnosis or clinical event classification. This article describes the diagnosis and adjudication processes. Methods: The diagnostic process was based on review of clinical data and high-resolution CT scans with central review of lung biopsies when available. The AC worked closely with the data coordinating center to obtain clinical, radiologic, and histologic data and to communicate with the clinical centers. The AC used a multidisciplinary discussion model with four clinicians, one radiologist, and one pathologist to adjudicate diagnosis and outcome measures. Results: The IPFnet trials screened 1,015 subjects; of these, 23 cases required review by the AC to establish eligibility. The most common diagnosis for exclusion was suspected chronic hypersensitivity pneumonitis. The AC reviewed 88 suspected acute exacerbations (AExs), 93 nonelective hospitalizations, and 16 cases of bleeding. Determination of AEx presented practical challenges to adjudicators, as necessary clinical data were oft en not collected, particularly when subjects were evaluated outside of the primary study site. Conclusions: The IPFnet diagnostic process was generally efficient, but a multidisciplinary adjudication committee was critical to assure correct phenotype for study enrollment. The AC was key in adjudicating all adverse outcomes in two IPFnet studies terminated early because of safety issues. Future clinical trials in IPF should consider logistical and cost issues as theyincorporate AExs and hospitalizations as outcome measures.

Original languageEnglish (US)
Pages (from-to)1034-1042
Number of pages9
JournalChest
Volume148
Issue number4
DOIs
StatePublished - Oct 1 2015

Fingerprint

Idiopathic Pulmonary Fibrosis
Research
Hospitalization
Outcome Assessment (Health Care)
National Heart, Lung, and Blood Institute (U.S.)
Extrinsic Allergic Alveolitis
Advisory Committees
Uncertainty
Clinical Trials
Hemorrhage
Phenotype
Biopsy
Safety
Costs and Cost Analysis
Drug Therapy
Lung

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

De Andrade, J., Schwarz, M., Collard, H. R., Gentry-Bumpass, T., Colby, T., Lynch, D., ... Kiley, J. (2015). The idiopathic pulmonary fibrosis clinical research network (IPFnet): Diagnostic and adjudication processes. Chest, 148(4), 1034-1042. https://doi.org/10.1378/chest.14-2889

The idiopathic pulmonary fibrosis clinical research network (IPFnet) : Diagnostic and adjudication processes. / De Andrade, Joao; Schwarz, Marvin; Collard, Harold R.; Gentry-Bumpass, Tedryl; Colby, Thomas; Lynch, David; Kaner, Robert J.; Schwarz, M.; Zisman, D. A.; Chapman, J.; Olman, M.; Lubell, S.; Morrison, L. D.; Steele, M. P.; Haram, T.; Roman, J.; Perez, R.; Perez, T.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Brown, K. K.; Schwarz, M.; Bair, C.; Kervitsky, D.; Lasky, J. A.; Ditta, S.; DeAndrade, J.; Thannickal, V. J.; Stewart, M.; Zisman, D. A.; Lynch, J.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J. A.; Wolters, P. J.; Jeffrey, R.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; White, S. R.; Brown, C.; Garic, I.; Maleckar, S.; Martinez, F. J.; Flaherty, K. R.; Han, M.; Moore, B.; Toews, G. B.; Dahlgren, D.; Raghu, G.; Hayes, J.; Snyder, M.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Mason, W.; Kaner, R. J.; Monroy, V.; Wang, M.; Lynch, D. A.; Anstrom, K. J.; Becker, R. C.; Eisenstein, E. L.; MacIntyre, N. R.; Morrison, L. D.; Rochon, J.; Steele, M. P.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Anderson, R.; Beci, R.; Calvert, S.; Cain, K.; Gentry-Bumpass, T.; Hill, D.; Ingham, M.; Kagan, E.; Kaur, J.; Matti, C.; McClelland, J.; Meredith, A.; Nguyen, T.; Pesarchick, J.; Roberts, R. S.; Tate, W.; Thomas, T.; Walker, J.; Whelan, D.; Winsor, J.; Yang, Q.; Yow, E.; Reynolds, H. Y.; Tian, X.; Kiley, J.; Olman, M.; Toews, G. B.; Hunninghake, G.; Culver, D. A.; Chapman, J.; Olman, M.; Lubell, S.; Wehrmann, R.; Morrison, L. D.; Steele, M. P.; Haram, T.; Kidd, R.; Kallay, M.; Lyda, E.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Sahn, S.; O'Banner, N.; Stokes, F.; Brown, K. K.; Bair, C.; Kervitsky, D.; Ettinger, N. A.; Merli, S.; De Andrade, J.; Thannickal, V. J.; Stewart, M.; Belperio, J.; Lynch, J. P.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J.; Wolters, P.; Eller, A.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; Maleckar, S.; Rahimova, G.; Sardin, L.; Roman, J.; Perez, R.; Perez, T.; Glassberg, M.; Simonet, E.; Martinez, F. J.; Baumann, K.; Chan, K.; Chughtai, A.; Gross, B.; Flaherty, K. R.; Han, M. L.; Hyzy, R.; Kazerooni, E.; Moore, B.; Myers, J.; Toews, G. B.; White, E.; Dahlgren, D.; Rossman, M.; Kreider, M.; Le, K.; Fitzgerald, J.; Glazer, C.; Scholand, M. B.; Brewster, L.; Johnson, A.; Raghu, G.; Berry-Bell, P.; Snydsman, A.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Kinser, K.; Richardson, R.; Mason, W.; Kaner, R. J.; Bandong, K.; Antin-Ozerkis, D.; Holm, C.; Estrom, J.; Lynch, D. A.; Colby, T.; Anstrom, K. J.; Eisenstein, E. L.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Beci, R.; Calvert, S.; Gentry-Bumpass, T.; Hill, D.; Hofmann, P. V.; Hwang, K.; Kaur, J.; Matti, C.; Meredith, A.; Pesarchick, J.; Ramey, S.; Roberts, R. S.; Sharlow, A.; Winsor, J.; Yang, Q.; Yow, E.; Weinmann, G. G.; Reynolds, H.; Schmetter, B.; Tian, X.; Kiley, J.; Martinez, F. J.; Raghu, G.; Schwarz, M.; Toews, G. B.; Zibrak, J.; Demersky, A.; Vey, M.; Rosas, I. O.; Debrosse, P.; Culver, D. A.; Chapman, J.; Olman, M.; Lubell, S.; Wehrmann, R.; Morrison, L. D.; Steele, M. P.; Haram, T.; Kidd, R.; Kallay, M.; Lyda, E.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Sahn, S.; O'Banner, N.; Stokes, F.; Padilla, M.; Berhanu, G.; Brown, K. K.; Bair, C.; Kervitsky, D.; Ettinger, N. A.; Merli, S.; Criner, G. J.; Swift, I. Q.; Satti, A.; Cordova, F.; Patel, N.; West, K.; Jones, G.; Lasky, J. A.; Ditta, S.; De Andrade, J.; Thannickal, V. J.; Stewart, M.; Belperio, J.; Lynch, J. P.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J.; Wolters, P.; Eller, A.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; Maleckar, S.; Rahimova, G.; Sardin, L.; Roman, J.; Perez, R.; Perez, T.; Glassberg, M.; Simonet, E.; Martinez, F. J.; Baumann, K.; Chan, K.; Chughtai, A.; Gross, B.; Flaherty, K. R.; Han, M. L.; Hyzy, R.; Kazerooni, E.; Moore, B.; Myers, J.; Toews, G. B.; White, E.; Dahlgren, D.; Rossman, M.; Kreider, M.; Le, K.; Fitzgerald, J.; Glazer, C.; Scholand, M. B.; Brewster, L.; Johnson, A.; Raghu, G.; Berry-Bell, P.; Snydsman, A.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Mason, W.; Kaner, R. J.; Bandong, K.; Antin-Ozerkis, D.; Holm, C.; Estrom, J.; Lynch, D. A.; Colby, T.; Anstrom, K. J.; Becker, R. C.; Eisenstein, E. L.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Beci, R.; Calvert, S.; Cain, K.; Gentry-Bumpass, T.; Hill, D.; Huang, K.; Kaur, J.; Matti, C.; Meredith, A.; Pesarchick, J.; Ramey, S.; Roberts, R. S.; Sharlow, A.; Winsor, J.; Yow, E.; Weinmann, G. G.; Reynolds, H.; Schmetter, B.; Tian, X.; Kiley, J.

In: Chest, Vol. 148, No. 4, 01.10.2015, p. 1034-1042.

Research output: Contribution to journalArticle

De Andrade, J, Schwarz, M, Collard, HR, Gentry-Bumpass, T, Colby, T, Lynch, D, Kaner, RJ, Schwarz, M, Zisman, DA, Chapman, J, Olman, M, Lubell, S, Morrison, LD, Steele, MP, Haram, T, Roman, J, Perez, R, Perez, T, Ryu, JH, Utz, JP, Limper, AH, Daniels, CE, Meiras, K, Walsh, S, Brown, KK, Schwarz, M, Bair, C, Kervitsky, D, Lasky, JA, Ditta, S, DeAndrade, J, Thannickal, VJ, Stewart, M, Zisman, DA, Lynch, J, Calahan, E, Lopez, P, King, TE, Collard, HR, Golden, JA, Wolters, PJ, Jeffrey, R, Noth, I, Hogarth, DK, Sandbo, N, Strek, ME, White, SR, Brown, C, Garic, I, Maleckar, S, Martinez, FJ, Flaherty, KR, Han, M, Moore, B, Toews, GB, Dahlgren, D, Raghu, G, Hayes, J, Snyder, M, Loyd, JE, Lancaster, L, Lawson, W, Greer, R, Mason, W, Kaner, RJ, Monroy, V, Wang, M, Lynch, DA, Anstrom, KJ, Becker, RC, Eisenstein, EL, MacIntyre, NR, Morrison, LD, Rochon, J, Steele, MP, Sundy, JS, Davidson-Ray, L, Dignacco, P, Edwards, R, Anderson, R, Beci, R, Calvert, S, Cain, K, Gentry-Bumpass, T, Hill, D, Ingham, M, Kagan, E, Kaur, J, Matti, C, McClelland, J, Meredith, A, Nguyen, T, Pesarchick, J, Roberts, RS, Tate, W, Thomas, T, Walker, J, Whelan, D, Winsor, J, Yang, Q, Yow, E, Reynolds, HY, Tian, X, Kiley, J, Olman, M, Toews, GB, Hunninghake, G, Culver, DA, Chapman, J, Olman, M, Lubell, S, Wehrmann, R, Morrison, LD, Steele, MP, Haram, T, Kidd, R, Kallay, M, Lyda, E, Ryu, JH, Utz, JP, Limper, AH, Daniels, CE, Meiras, K, Walsh, S, Sahn, S, O'Banner, N, Stokes, F, Brown, KK, Bair, C, Kervitsky, D, Ettinger, NA, Merli, S, De Andrade, J, Thannickal, VJ, Stewart, M, Belperio, J, Lynch, JP, Calahan, E, Lopez, P, King, TE, Collard, HR, Golden, J, Wolters, P, Eller, A, Noth, I, Hogarth, DK, Sandbo, N, Strek, ME, Maleckar, S, Rahimova, G, Sardin, L, Roman, J, Perez, R, Perez, T, Glassberg, M, Simonet, E, Martinez, FJ, Baumann, K, Chan, K, Chughtai, A, Gross, B, Flaherty, KR, Han, ML, Hyzy, R, Kazerooni, E, Moore, B, Myers, J, Toews, GB, White, E, Dahlgren, D, Rossman, M, Kreider, M, Le, K, Fitzgerald, J, Glazer, C, Scholand, MB, Brewster, L, Johnson, A, Raghu, G, Berry-Bell, P, Snydsman, A, Loyd, JE, Lancaster, L, Lawson, W, Greer, R, Kinser, K, Richardson, R, Mason, W, Kaner, RJ, Bandong, K, Antin-Ozerkis, D, Holm, C, Estrom, J, Lynch, DA, Colby, T, Anstrom, KJ, Eisenstein, EL, Sundy, JS, Davidson-Ray, L, Dignacco, P, Edwards, R, Beci, R, Calvert, S, Gentry-Bumpass, T, Hill, D, Hofmann, PV, Hwang, K, Kaur, J, Matti, C, Meredith, A, Pesarchick, J, Ramey, S, Roberts, RS, Sharlow, A, Winsor, J, Yang, Q, Yow, E, Weinmann, GG, Reynolds, H, Schmetter, B, Tian, X, Kiley, J, Martinez, FJ, Raghu, G, Schwarz, M, Toews, GB, Zibrak, J, Demersky, A, Vey, M, Rosas, IO, Debrosse, P, Culver, DA, Chapman, J, Olman, M, Lubell, S, Wehrmann, R, Morrison, LD, Steele, MP, Haram, T, Kidd, R, Kallay, M, Lyda, E, Ryu, JH, Utz, JP, Limper, AH, Daniels, CE, Meiras, K, Walsh, S, Sahn, S, O'Banner, N, Stokes, F, Padilla, M, Berhanu, G, Brown, KK, Bair, C, Kervitsky, D, Ettinger, NA, Merli, S, Criner, GJ, Swift, IQ, Satti, A, Cordova, F, Patel, N, West, K, Jones, G, Lasky, JA, Ditta, S, De Andrade, J, Thannickal, VJ, Stewart, M, Belperio, J, Lynch, JP, Calahan, E, Lopez, P, King, TE, Collard, HR, Golden, J, Wolters, P, Eller, A, Noth, I, Hogarth, DK, Sandbo, N, Strek, ME, Maleckar, S, Rahimova, G, Sardin, L, Roman, J, Perez, R, Perez, T, Glassberg, M, Simonet, E, Martinez, FJ, Baumann, K, Chan, K, Chughtai, A, Gross, B, Flaherty, KR, Han, ML, Hyzy, R, Kazerooni, E, Moore, B, Myers, J, Toews, GB, White, E, Dahlgren, D, Rossman, M, Kreider, M, Le, K, Fitzgerald, J, Glazer, C, Scholand, MB, Brewster, L, Johnson, A, Raghu, G, Berry-Bell, P, Snydsman, A, Loyd, JE, Lancaster, L, Lawson, W, Greer, R, Mason, W, Kaner, RJ, Bandong, K, Antin-Ozerkis, D, Holm, C, Estrom, J, Lynch, DA, Colby, T, Anstrom, KJ, Becker, RC, Eisenstein, EL, Sundy, JS, Davidson-Ray, L, Dignacco, P, Edwards, R, Beci, R, Calvert, S, Cain, K, Gentry-Bumpass, T, Hill, D, Huang, K, Kaur, J, Matti, C, Meredith, A, Pesarchick, J, Ramey, S, Roberts, RS, Sharlow, A, Winsor, J, Yow, E, Weinmann, GG, Reynolds, H, Schmetter, B, Tian, X & Kiley, J 2015, 'The idiopathic pulmonary fibrosis clinical research network (IPFnet): Diagnostic and adjudication processes', Chest, vol. 148, no. 4, pp. 1034-1042. https://doi.org/10.1378/chest.14-2889
De Andrade J, Schwarz M, Collard HR, Gentry-Bumpass T, Colby T, Lynch D et al. The idiopathic pulmonary fibrosis clinical research network (IPFnet): Diagnostic and adjudication processes. Chest. 2015 Oct 1;148(4):1034-1042. https://doi.org/10.1378/chest.14-2889
De Andrade, Joao ; Schwarz, Marvin ; Collard, Harold R. ; Gentry-Bumpass, Tedryl ; Colby, Thomas ; Lynch, David ; Kaner, Robert J. ; Schwarz, M. ; Zisman, D. A. ; Chapman, J. ; Olman, M. ; Lubell, S. ; Morrison, L. D. ; Steele, M. P. ; Haram, T. ; Roman, J. ; Perez, R. ; Perez, T. ; Ryu, J. H. ; Utz, J. P. ; Limper, A. H. ; Daniels, C. E. ; Meiras, K. ; Walsh, S. ; Brown, K. K. ; Schwarz, M. ; Bair, C. ; Kervitsky, D. ; Lasky, J. A. ; Ditta, S. ; DeAndrade, J. ; Thannickal, V. J. ; Stewart, M. ; Zisman, D. A. ; Lynch, J. ; Calahan, E. ; Lopez, P. ; King, T. E. ; Collard, H. R. ; Golden, J. A. ; Wolters, P. J. ; Jeffrey, R. ; Noth, I. ; Hogarth, D. K. ; Sandbo, N. ; Strek, M. E. ; White, S. R. ; Brown, C. ; Garic, I. ; Maleckar, S. ; Martinez, F. J. ; Flaherty, K. R. ; Han, M. ; Moore, B. ; Toews, G. B. ; Dahlgren, D. ; Raghu, G. ; Hayes, J. ; Snyder, M. ; Loyd, J. E. ; Lancaster, L. ; Lawson, W. ; Greer, R. ; Mason, W. ; Kaner, R. J. ; Monroy, V. ; Wang, M. ; Lynch, D. A. ; Anstrom, K. J. ; Becker, R. C. ; Eisenstein, E. L. ; MacIntyre, N. R. ; Morrison, L. D. ; Rochon, J. ; Steele, M. P. ; Sundy, J. S. ; Davidson-Ray, L. ; Dignacco, P. ; Edwards, R. ; Anderson, R. ; Beci, R. ; Calvert, S. ; Cain, K. ; Gentry-Bumpass, T. ; Hill, D. ; Ingham, M. ; Kagan, E. ; Kaur, J. ; Matti, C. ; McClelland, J. ; Meredith, A. ; Nguyen, T. ; Pesarchick, J. ; Roberts, R. S. ; Tate, W. ; Thomas, T. ; Walker, J. ; Whelan, D. ; Winsor, J. ; Yang, Q. ; Yow, E. ; Reynolds, H. Y. ; Tian, X. ; Kiley, J. ; Olman, M. ; Toews, G. B. ; Hunninghake, G. ; Culver, D. A. ; Chapman, J. ; Olman, M. ; Lubell, S. ; Wehrmann, R. ; Morrison, L. D. ; Steele, M. P. ; Haram, T. ; Kidd, R. ; Kallay, M. ; Lyda, E. ; Ryu, J. H. ; Utz, J. P. ; Limper, A. H. ; Daniels, C. E. ; Meiras, K. ; Walsh, S. ; Sahn, S. ; O'Banner, N. ; Stokes, F. ; Brown, K. K. ; Bair, C. ; Kervitsky, D. ; Ettinger, N. A. ; Merli, S. ; De Andrade, J. ; Thannickal, V. J. ; Stewart, M. ; Belperio, J. ; Lynch, J. P. ; Calahan, E. ; Lopez, P. ; King, T. E. ; Collard, H. R. ; Golden, J. ; Wolters, P. ; Eller, A. ; Noth, I. ; Hogarth, D. K. ; Sandbo, N. ; Strek, M. E. ; Maleckar, S. ; Rahimova, G. ; Sardin, L. ; Roman, J. ; Perez, R. ; Perez, T. ; Glassberg, M. ; Simonet, E. ; Martinez, F. J. ; Baumann, K. ; Chan, K. ; Chughtai, A. ; Gross, B. ; Flaherty, K. R. ; Han, M. L. ; Hyzy, R. ; Kazerooni, E. ; Moore, B. ; Myers, J. ; Toews, G. B. ; White, E. ; Dahlgren, D. ; Rossman, M. ; Kreider, M. ; Le, K. ; Fitzgerald, J. ; Glazer, C. ; Scholand, M. B. ; Brewster, L. ; Johnson, A. ; Raghu, G. ; Berry-Bell, P. ; Snydsman, A. ; Loyd, J. E. ; Lancaster, L. ; Lawson, W. ; Greer, R. ; Kinser, K. ; Richardson, R. ; Mason, W. ; Kaner, R. J. ; Bandong, K. ; Antin-Ozerkis, D. ; Holm, C. ; Estrom, J. ; Lynch, D. A. ; Colby, T. ; Anstrom, K. J. ; Eisenstein, E. L. ; Sundy, J. S. ; Davidson-Ray, L. ; Dignacco, P. ; Edwards, R. ; Beci, R. ; Calvert, S. ; Gentry-Bumpass, T. ; Hill, D. ; Hofmann, P. V. ; Hwang, K. ; Kaur, J. ; Matti, C. ; Meredith, A. ; Pesarchick, J. ; Ramey, S. ; Roberts, R. S. ; Sharlow, A. ; Winsor, J. ; Yang, Q. ; Yow, E. ; Weinmann, G. G. ; Reynolds, H. ; Schmetter, B. ; Tian, X. ; Kiley, J. ; Martinez, F. J. ; Raghu, G. ; Schwarz, M. ; Toews, G. B. ; Zibrak, J. ; Demersky, A. ; Vey, M. ; Rosas, I. O. ; Debrosse, P. ; Culver, D. A. ; Chapman, J. ; Olman, M. ; Lubell, S. ; Wehrmann, R. ; Morrison, L. D. ; Steele, M. P. ; Haram, T. ; Kidd, R. ; Kallay, M. ; Lyda, E. ; Ryu, J. H. ; Utz, J. P. ; Limper, A. H. ; Daniels, C. E. ; Meiras, K. ; Walsh, S. ; Sahn, S. ; O'Banner, N. ; Stokes, F. ; Padilla, M. ; Berhanu, G. ; Brown, K. K. ; Bair, C. ; Kervitsky, D. ; Ettinger, N. A. ; Merli, S. ; Criner, G. J. ; Swift, I. Q. ; Satti, A. ; Cordova, F. ; Patel, N. ; West, K. ; Jones, G. ; Lasky, J. A. ; Ditta, S. ; De Andrade, J. ; Thannickal, V. J. ; Stewart, M. ; Belperio, J. ; Lynch, J. P. ; Calahan, E. ; Lopez, P. ; King, T. E. ; Collard, H. R. ; Golden, J. ; Wolters, P. ; Eller, A. ; Noth, I. ; Hogarth, D. K. ; Sandbo, N. ; Strek, M. E. ; Maleckar, S. ; Rahimova, G. ; Sardin, L. ; Roman, J. ; Perez, R. ; Perez, T. ; Glassberg, M. ; Simonet, E. ; Martinez, F. J. ; Baumann, K. ; Chan, K. ; Chughtai, A. ; Gross, B. ; Flaherty, K. R. ; Han, M. L. ; Hyzy, R. ; Kazerooni, E. ; Moore, B. ; Myers, J. ; Toews, G. B. ; White, E. ; Dahlgren, D. ; Rossman, M. ; Kreider, M. ; Le, K. ; Fitzgerald, J. ; Glazer, C. ; Scholand, M. B. ; Brewster, L. ; Johnson, A. ; Raghu, G. ; Berry-Bell, P. ; Snydsman, A. ; Loyd, J. E. ; Lancaster, L. ; Lawson, W. ; Greer, R. ; Mason, W. ; Kaner, R. J. ; Bandong, K. ; Antin-Ozerkis, D. ; Holm, C. ; Estrom, J. ; Lynch, D. A. ; Colby, T. ; Anstrom, K. J. ; Becker, R. C. ; Eisenstein, E. L. ; Sundy, J. S. ; Davidson-Ray, L. ; Dignacco, P. ; Edwards, R. ; Beci, R. ; Calvert, S. ; Cain, K. ; Gentry-Bumpass, T. ; Hill, D. ; Huang, K. ; Kaur, J. ; Matti, C. ; Meredith, A. ; Pesarchick, J. ; Ramey, S. ; Roberts, R. S. ; Sharlow, A. ; Winsor, J. ; Yow, E. ; Weinmann, G. G. ; Reynolds, H. ; Schmetter, B. ; Tian, X. ; Kiley, J. / The idiopathic pulmonary fibrosis clinical research network (IPFnet) : Diagnostic and adjudication processes. In: Chest. 2015 ; Vol. 148, No. 4. pp. 1034-1042.
@article{4a030d1110394862801ed7a0348a32fd,
title = "The idiopathic pulmonary fibrosis clinical research network (IPFnet): Diagnostic and adjudication processes",
abstract = "Background: The National Heart, Lung, and Blood Institute-sponsored IPF Clinical Research Network (IPFnet) studies enrolled subjects with idiopathic pulmonary fibrosis (IPF) to evaluate drug therapies in treatment trials. An adjudication committee (AC) provided a structured review of cases in which there was uncertainty or disagreement regarding diagnosis or clinical event classification. This article describes the diagnosis and adjudication processes. Methods: The diagnostic process was based on review of clinical data and high-resolution CT scans with central review of lung biopsies when available. The AC worked closely with the data coordinating center to obtain clinical, radiologic, and histologic data and to communicate with the clinical centers. The AC used a multidisciplinary discussion model with four clinicians, one radiologist, and one pathologist to adjudicate diagnosis and outcome measures. Results: The IPFnet trials screened 1,015 subjects; of these, 23 cases required review by the AC to establish eligibility. The most common diagnosis for exclusion was suspected chronic hypersensitivity pneumonitis. The AC reviewed 88 suspected acute exacerbations (AExs), 93 nonelective hospitalizations, and 16 cases of bleeding. Determination of AEx presented practical challenges to adjudicators, as necessary clinical data were oft en not collected, particularly when subjects were evaluated outside of the primary study site. Conclusions: The IPFnet diagnostic process was generally efficient, but a multidisciplinary adjudication committee was critical to assure correct phenotype for study enrollment. The AC was key in adjudicating all adverse outcomes in two IPFnet studies terminated early because of safety issues. Future clinical trials in IPF should consider logistical and cost issues as theyincorporate AExs and hospitalizations as outcome measures.",
author = "{De Andrade}, Joao and Marvin Schwarz and Collard, {Harold R.} and Tedryl Gentry-Bumpass and Thomas Colby and David Lynch and Kaner, {Robert J.} and M. Schwarz and Zisman, {D. A.} and J. Chapman and M. Olman and S. Lubell and Morrison, {L. D.} and Steele, {M. P.} and T. Haram and J. Roman and R. Perez and T. Perez and Ryu, {J. H.} and Utz, {J. P.} and Limper, {A. H.} and Daniels, {C. E.} and K. Meiras and S. Walsh and Brown, {K. K.} and M. Schwarz and C. Bair and D. Kervitsky and Lasky, {J. A.} and S. Ditta and J. DeAndrade and Thannickal, {V. J.} and M. Stewart and Zisman, {D. A.} and J. Lynch and E. Calahan and P. Lopez and King, {T. E.} and Collard, {H. R.} and Golden, {J. A.} and Wolters, {P. J.} and R. Jeffrey and I. Noth and Hogarth, {D. K.} and N. Sandbo and Strek, {M. E.} and White, {S. R.} and C. Brown and I. Garic and S. Maleckar and Martinez, {F. J.} and Flaherty, {K. R.} and M. Han and B. Moore and Toews, {G. B.} and D. Dahlgren and G. Raghu and J. Hayes and M. Snyder and Loyd, {J. E.} and L. Lancaster and W. Lawson and R. Greer and W. Mason and Kaner, {R. J.} and V. Monroy and M. Wang and Lynch, {D. A.} and Anstrom, {K. J.} and Becker, {R. C.} and Eisenstein, {E. L.} and MacIntyre, {N. R.} and Morrison, {L. D.} and J. Rochon and Steele, {M. P.} and Sundy, {J. S.} and L. Davidson-Ray and P. Dignacco and R. Edwards and R. Anderson and R. Beci and S. Calvert and K. Cain and T. Gentry-Bumpass and D. Hill and M. Ingham and E. Kagan and J. Kaur and C. Matti and J. McClelland and A. Meredith and T. Nguyen and J. Pesarchick and Roberts, {R. S.} and W. Tate and T. Thomas and J. Walker and D. Whelan and J. Winsor and Q. Yang and E. Yow and Reynolds, {H. Y.} and X. Tian and J. Kiley and M. Olman and Toews, {G. B.} and G. Hunninghake and Culver, {D. A.} and J. Chapman and M. Olman and S. Lubell and R. Wehrmann and Morrison, {L. D.} and Steele, {M. P.} and T. Haram and R. Kidd and M. Kallay and E. Lyda and Ryu, {J. H.} and Utz, {J. P.} and Limper, {A. H.} and Daniels, {C. E.} and K. Meiras and S. Walsh and S. Sahn and N. O'Banner and F. Stokes and Brown, {K. K.} and C. Bair and D. Kervitsky and Ettinger, {N. A.} and S. Merli and {De Andrade}, J. and Thannickal, {V. J.} and M. Stewart and J. Belperio and Lynch, {J. P.} and E. Calahan and P. Lopez and King, {T. E.} and Collard, {H. R.} and J. Golden and P. Wolters and A. Eller and I. Noth and Hogarth, {D. K.} and N. Sandbo and Strek, {M. E.} and S. Maleckar and G. Rahimova and L. Sardin and J. Roman and R. Perez and T. Perez and M. Glassberg and E. Simonet and Martinez, {F. J.} and K. Baumann and K. Chan and A. Chughtai and B. Gross and Flaherty, {K. R.} and Han, {M. L.} and R. Hyzy and E. Kazerooni and B. Moore and J. Myers and Toews, {G. B.} and E. White and D. Dahlgren and M. Rossman and M. Kreider and K. Le and J. Fitzgerald and C. Glazer and Scholand, {M. B.} and L. Brewster and A. Johnson and G. Raghu and P. Berry-Bell and A. Snydsman and Loyd, {J. E.} and L. Lancaster and W. Lawson and R. Greer and K. Kinser and R. Richardson and W. Mason and Kaner, {R. J.} and K. Bandong and D. Antin-Ozerkis and C. Holm and J. Estrom and Lynch, {D. A.} and T. Colby and Anstrom, {K. J.} and Eisenstein, {E. L.} and Sundy, {J. S.} and L. Davidson-Ray and P. Dignacco and R. Edwards and R. Beci and S. Calvert and T. Gentry-Bumpass and D. Hill and Hofmann, {P. V.} and K. Hwang and J. Kaur and C. Matti and A. Meredith and J. Pesarchick and S. Ramey and Roberts, {R. S.} and A. Sharlow and J. Winsor and Q. Yang and E. Yow and Weinmann, {G. G.} and H. Reynolds and B. Schmetter and X. Tian and J. Kiley and Martinez, {F. J.} and G. Raghu and M. Schwarz and Toews, {G. B.} and J. Zibrak and A. Demersky and M. Vey and Rosas, {I. O.} and P. Debrosse and Culver, {D. A.} and J. Chapman and M. Olman and S. Lubell and R. Wehrmann and Morrison, {L. D.} and Steele, {M. P.} and T. Haram and R. Kidd and M. Kallay and E. Lyda and Ryu, {J. H.} and Utz, {J. P.} and Limper, {A. H.} and Daniels, {C. E.} and K. Meiras and S. Walsh and S. Sahn and N. O'Banner and F. Stokes and M. Padilla and G. Berhanu and Brown, {K. K.} and C. Bair and D. Kervitsky and Ettinger, {N. A.} and S. Merli and Criner, {G. J.} and Swift, {I. Q.} and A. Satti and F. Cordova and N. Patel and K. West and G. Jones and Lasky, {J. A.} and S. Ditta and {De Andrade}, J. and Thannickal, {V. J.} and M. Stewart and J. Belperio and Lynch, {J. P.} and E. Calahan and P. Lopez and King, {T. E.} and Collard, {H. R.} and J. Golden and P. Wolters and A. Eller and I. Noth and Hogarth, {D. K.} and N. Sandbo and Strek, {M. E.} and S. Maleckar and G. Rahimova and L. Sardin and J. Roman and R. Perez and T. Perez and M. Glassberg and E. Simonet and Martinez, {F. J.} and K. Baumann and K. Chan and A. Chughtai and B. Gross and Flaherty, {K. R.} and Han, {M. L.} and R. Hyzy and E. Kazerooni and B. Moore and J. Myers and Toews, {G. B.} and E. White and D. Dahlgren and M. Rossman and M. Kreider and K. Le and J. Fitzgerald and C. Glazer and Scholand, {M. B.} and L. Brewster and A. Johnson and G. Raghu and P. Berry-Bell and A. Snydsman and Loyd, {J. E.} and L. Lancaster and W. Lawson and R. Greer and W. Mason and Kaner, {R. J.} and K. Bandong and D. Antin-Ozerkis and C. Holm and J. Estrom and Lynch, {D. A.} and T. Colby and Anstrom, {K. J.} and Becker, {R. C.} and Eisenstein, {E. L.} and Sundy, {J. S.} and L. Davidson-Ray and P. Dignacco and R. Edwards and R. Beci and S. Calvert and K. Cain and T. Gentry-Bumpass and D. Hill and K. Huang and J. Kaur and C. Matti and A. Meredith and J. Pesarchick and S. Ramey and Roberts, {R. S.} and A. Sharlow and J. Winsor and E. Yow and Weinmann, {G. G.} and H. Reynolds and B. Schmetter and X. Tian and J. Kiley",
year = "2015",
month = "10",
day = "1",
doi = "10.1378/chest.14-2889",
language = "English (US)",
volume = "148",
pages = "1034--1042",
journal = "Chest",
issn = "0012-3692",
publisher = "American College of Chest Physicians",
number = "4",

}

TY - JOUR

T1 - The idiopathic pulmonary fibrosis clinical research network (IPFnet)

T2 - Diagnostic and adjudication processes

AU - De Andrade, Joao

AU - Schwarz, Marvin

AU - Collard, Harold R.

AU - Gentry-Bumpass, Tedryl

AU - Colby, Thomas

AU - Lynch, David

AU - Kaner, Robert J.

AU - Schwarz, M.

AU - Zisman, D. A.

AU - Chapman, J.

AU - Olman, M.

AU - Lubell, S.

AU - Morrison, L. D.

AU - Steele, M. P.

AU - Haram, T.

AU - Roman, J.

AU - Perez, R.

AU - Perez, T.

AU - Ryu, J. H.

AU - Utz, J. P.

AU - Limper, A. H.

AU - Daniels, C. E.

AU - Meiras, K.

AU - Walsh, S.

AU - Brown, K. K.

AU - Schwarz, M.

AU - Bair, C.

AU - Kervitsky, D.

AU - Lasky, J. A.

AU - Ditta, S.

AU - DeAndrade, J.

AU - Thannickal, V. J.

AU - Stewart, M.

AU - Zisman, D. A.

AU - Lynch, J.

AU - Calahan, E.

AU - Lopez, P.

AU - King, T. E.

AU - Collard, H. R.

AU - Golden, J. A.

AU - Wolters, P. J.

AU - Jeffrey, R.

AU - Noth, I.

AU - Hogarth, D. K.

AU - Sandbo, N.

AU - Strek, M. E.

AU - White, S. R.

AU - Brown, C.

AU - Garic, I.

AU - Maleckar, S.

AU - Martinez, F. J.

AU - Flaherty, K. R.

AU - Han, M.

AU - Moore, B.

AU - Toews, G. B.

AU - Dahlgren, D.

AU - Raghu, G.

AU - Hayes, J.

AU - Snyder, M.

AU - Loyd, J. E.

AU - Lancaster, L.

AU - Lawson, W.

AU - Greer, R.

AU - Mason, W.

AU - Kaner, R. J.

AU - Monroy, V.

AU - Wang, M.

AU - Lynch, D. A.

AU - Anstrom, K. J.

AU - Becker, R. C.

AU - Eisenstein, E. L.

AU - MacIntyre, N. R.

AU - Morrison, L. D.

AU - Rochon, J.

AU - Steele, M. P.

AU - Sundy, J. S.

AU - Davidson-Ray, L.

AU - Dignacco, P.

AU - Edwards, R.

AU - Anderson, R.

AU - Beci, R.

AU - Calvert, S.

AU - Cain, K.

AU - Gentry-Bumpass, T.

AU - Hill, D.

AU - Ingham, M.

AU - Kagan, E.

AU - Kaur, J.

AU - Matti, C.

AU - McClelland, J.

AU - Meredith, A.

AU - Nguyen, T.

AU - Pesarchick, J.

AU - Roberts, R. S.

AU - Tate, W.

AU - Thomas, T.

AU - Walker, J.

AU - Whelan, D.

AU - Winsor, J.

AU - Yang, Q.

AU - Yow, E.

AU - Reynolds, H. Y.

AU - Tian, X.

AU - Kiley, J.

AU - Olman, M.

AU - Toews, G. B.

AU - Hunninghake, G.

AU - Culver, D. A.

AU - Chapman, J.

AU - Olman, M.

AU - Lubell, S.

AU - Wehrmann, R.

AU - Morrison, L. D.

AU - Steele, M. P.

AU - Haram, T.

AU - Kidd, R.

AU - Kallay, M.

AU - Lyda, E.

AU - Ryu, J. H.

AU - Utz, J. P.

AU - Limper, A. H.

AU - Daniels, C. E.

AU - Meiras, K.

AU - Walsh, S.

AU - Sahn, S.

AU - O'Banner, N.

AU - Stokes, F.

AU - Brown, K. K.

AU - Bair, C.

AU - Kervitsky, D.

AU - Ettinger, N. A.

AU - Merli, S.

AU - De Andrade, J.

AU - Thannickal, V. J.

AU - Stewart, M.

AU - Belperio, J.

AU - Lynch, J. P.

AU - Calahan, E.

AU - Lopez, P.

AU - King, T. E.

AU - Collard, H. R.

AU - Golden, J.

AU - Wolters, P.

AU - Eller, A.

AU - Noth, I.

AU - Hogarth, D. K.

AU - Sandbo, N.

AU - Strek, M. E.

AU - Maleckar, S.

AU - Rahimova, G.

AU - Sardin, L.

AU - Roman, J.

AU - Perez, R.

AU - Perez, T.

AU - Glassberg, M.

AU - Simonet, E.

AU - Martinez, F. J.

AU - Baumann, K.

AU - Chan, K.

AU - Chughtai, A.

AU - Gross, B.

AU - Flaherty, K. R.

AU - Han, M. L.

AU - Hyzy, R.

AU - Kazerooni, E.

AU - Moore, B.

AU - Myers, J.

AU - Toews, G. B.

AU - White, E.

AU - Dahlgren, D.

AU - Rossman, M.

AU - Kreider, M.

AU - Le, K.

AU - Fitzgerald, J.

AU - Glazer, C.

AU - Scholand, M. B.

AU - Brewster, L.

AU - Johnson, A.

AU - Raghu, G.

AU - Berry-Bell, P.

AU - Snydsman, A.

AU - Loyd, J. E.

AU - Lancaster, L.

AU - Lawson, W.

AU - Greer, R.

AU - Kinser, K.

AU - Richardson, R.

AU - Mason, W.

AU - Kaner, R. J.

AU - Bandong, K.

AU - Antin-Ozerkis, D.

AU - Holm, C.

AU - Estrom, J.

AU - Lynch, D. A.

AU - Colby, T.

AU - Anstrom, K. J.

AU - Eisenstein, E. L.

AU - Sundy, J. S.

AU - Davidson-Ray, L.

AU - Dignacco, P.

AU - Edwards, R.

AU - Beci, R.

AU - Calvert, S.

AU - Gentry-Bumpass, T.

AU - Hill, D.

AU - Hofmann, P. V.

AU - Hwang, K.

AU - Kaur, J.

AU - Matti, C.

AU - Meredith, A.

AU - Pesarchick, J.

AU - Ramey, S.

AU - Roberts, R. S.

AU - Sharlow, A.

AU - Winsor, J.

AU - Yang, Q.

AU - Yow, E.

AU - Weinmann, G. G.

AU - Reynolds, H.

AU - Schmetter, B.

AU - Tian, X.

AU - Kiley, J.

AU - Martinez, F. J.

AU - Raghu, G.

AU - Schwarz, M.

AU - Toews, G. B.

AU - Zibrak, J.

AU - Demersky, A.

AU - Vey, M.

AU - Rosas, I. O.

AU - Debrosse, P.

AU - Culver, D. A.

AU - Chapman, J.

AU - Olman, M.

AU - Lubell, S.

AU - Wehrmann, R.

AU - Morrison, L. D.

AU - Steele, M. P.

AU - Haram, T.

AU - Kidd, R.

AU - Kallay, M.

AU - Lyda, E.

AU - Ryu, J. H.

AU - Utz, J. P.

AU - Limper, A. H.

AU - Daniels, C. E.

AU - Meiras, K.

AU - Walsh, S.

AU - Sahn, S.

AU - O'Banner, N.

AU - Stokes, F.

AU - Padilla, M.

AU - Berhanu, G.

AU - Brown, K. K.

AU - Bair, C.

AU - Kervitsky, D.

AU - Ettinger, N. A.

AU - Merli, S.

AU - Criner, G. J.

AU - Swift, I. Q.

AU - Satti, A.

AU - Cordova, F.

AU - Patel, N.

AU - West, K.

AU - Jones, G.

AU - Lasky, J. A.

AU - Ditta, S.

AU - De Andrade, J.

AU - Thannickal, V. J.

AU - Stewart, M.

AU - Belperio, J.

AU - Lynch, J. P.

AU - Calahan, E.

AU - Lopez, P.

AU - King, T. E.

AU - Collard, H. R.

AU - Golden, J.

AU - Wolters, P.

AU - Eller, A.

AU - Noth, I.

AU - Hogarth, D. K.

AU - Sandbo, N.

AU - Strek, M. E.

AU - Maleckar, S.

AU - Rahimova, G.

AU - Sardin, L.

AU - Roman, J.

AU - Perez, R.

AU - Perez, T.

AU - Glassberg, M.

AU - Simonet, E.

AU - Martinez, F. J.

AU - Baumann, K.

AU - Chan, K.

AU - Chughtai, A.

AU - Gross, B.

AU - Flaherty, K. R.

AU - Han, M. L.

AU - Hyzy, R.

AU - Kazerooni, E.

AU - Moore, B.

AU - Myers, J.

AU - Toews, G. B.

AU - White, E.

AU - Dahlgren, D.

AU - Rossman, M.

AU - Kreider, M.

AU - Le, K.

AU - Fitzgerald, J.

AU - Glazer, C.

AU - Scholand, M. B.

AU - Brewster, L.

AU - Johnson, A.

AU - Raghu, G.

AU - Berry-Bell, P.

AU - Snydsman, A.

AU - Loyd, J. E.

AU - Lancaster, L.

AU - Lawson, W.

AU - Greer, R.

AU - Mason, W.

AU - Kaner, R. J.

AU - Bandong, K.

AU - Antin-Ozerkis, D.

AU - Holm, C.

AU - Estrom, J.

AU - Lynch, D. A.

AU - Colby, T.

AU - Anstrom, K. J.

AU - Becker, R. C.

AU - Eisenstein, E. L.

AU - Sundy, J. S.

AU - Davidson-Ray, L.

AU - Dignacco, P.

AU - Edwards, R.

AU - Beci, R.

AU - Calvert, S.

AU - Cain, K.

AU - Gentry-Bumpass, T.

AU - Hill, D.

AU - Huang, K.

AU - Kaur, J.

AU - Matti, C.

AU - Meredith, A.

AU - Pesarchick, J.

AU - Ramey, S.

AU - Roberts, R. S.

AU - Sharlow, A.

AU - Winsor, J.

AU - Yow, E.

AU - Weinmann, G. G.

AU - Reynolds, H.

AU - Schmetter, B.

AU - Tian, X.

AU - Kiley, J.

PY - 2015/10/1

Y1 - 2015/10/1

N2 - Background: The National Heart, Lung, and Blood Institute-sponsored IPF Clinical Research Network (IPFnet) studies enrolled subjects with idiopathic pulmonary fibrosis (IPF) to evaluate drug therapies in treatment trials. An adjudication committee (AC) provided a structured review of cases in which there was uncertainty or disagreement regarding diagnosis or clinical event classification. This article describes the diagnosis and adjudication processes. Methods: The diagnostic process was based on review of clinical data and high-resolution CT scans with central review of lung biopsies when available. The AC worked closely with the data coordinating center to obtain clinical, radiologic, and histologic data and to communicate with the clinical centers. The AC used a multidisciplinary discussion model with four clinicians, one radiologist, and one pathologist to adjudicate diagnosis and outcome measures. Results: The IPFnet trials screened 1,015 subjects; of these, 23 cases required review by the AC to establish eligibility. The most common diagnosis for exclusion was suspected chronic hypersensitivity pneumonitis. The AC reviewed 88 suspected acute exacerbations (AExs), 93 nonelective hospitalizations, and 16 cases of bleeding. Determination of AEx presented practical challenges to adjudicators, as necessary clinical data were oft en not collected, particularly when subjects were evaluated outside of the primary study site. Conclusions: The IPFnet diagnostic process was generally efficient, but a multidisciplinary adjudication committee was critical to assure correct phenotype for study enrollment. The AC was key in adjudicating all adverse outcomes in two IPFnet studies terminated early because of safety issues. Future clinical trials in IPF should consider logistical and cost issues as theyincorporate AExs and hospitalizations as outcome measures.

AB - Background: The National Heart, Lung, and Blood Institute-sponsored IPF Clinical Research Network (IPFnet) studies enrolled subjects with idiopathic pulmonary fibrosis (IPF) to evaluate drug therapies in treatment trials. An adjudication committee (AC) provided a structured review of cases in which there was uncertainty or disagreement regarding diagnosis or clinical event classification. This article describes the diagnosis and adjudication processes. Methods: The diagnostic process was based on review of clinical data and high-resolution CT scans with central review of lung biopsies when available. The AC worked closely with the data coordinating center to obtain clinical, radiologic, and histologic data and to communicate with the clinical centers. The AC used a multidisciplinary discussion model with four clinicians, one radiologist, and one pathologist to adjudicate diagnosis and outcome measures. Results: The IPFnet trials screened 1,015 subjects; of these, 23 cases required review by the AC to establish eligibility. The most common diagnosis for exclusion was suspected chronic hypersensitivity pneumonitis. The AC reviewed 88 suspected acute exacerbations (AExs), 93 nonelective hospitalizations, and 16 cases of bleeding. Determination of AEx presented practical challenges to adjudicators, as necessary clinical data were oft en not collected, particularly when subjects were evaluated outside of the primary study site. Conclusions: The IPFnet diagnostic process was generally efficient, but a multidisciplinary adjudication committee was critical to assure correct phenotype for study enrollment. The AC was key in adjudicating all adverse outcomes in two IPFnet studies terminated early because of safety issues. Future clinical trials in IPF should consider logistical and cost issues as theyincorporate AExs and hospitalizations as outcome measures.

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U2 - 10.1378/chest.14-2889

DO - 10.1378/chest.14-2889

M3 - Article

VL - 148

SP - 1034

EP - 1042

JO - Chest

JF - Chest

SN - 0012-3692

IS - 4

ER -