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 language | English (US) |
|---|---|
| Pages (from-to) | 1034-1042 |
| Number of pages | 9 |
| Journal | CHEST |
| Volume | 148 |
| Issue number | 4 |
| DOIs | |
| State | Published - Oct 1 2015 |
| Externally published | Yes |
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Critical Care and Intensive Care Medicine
- Cardiology and Cardiovascular Medicine
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In: CHEST, Vol. 148, No. 4, 01.10.2015, p. 1034-1042.
Research output: Contribution to journal › Article › peer-review
}
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 - 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 - 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 - 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 - 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 - 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 - 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.
N1 - Funding Information: FUNDING/SUPPORT: The IPFnet was funded by the National Heart, Lung, and Blood Institute [Grants U10HL80513 (data coordinating center), U10HL80413, U10HL80274, U10HL80370, U10HL80371, U10HL80383, U10HL80411, U10HL80509, U10HL80510, U10HL80543, U10HL80571, and U10HL80685 (clinical centers)] and The Cowlin Family Fund at the Chicago Community Trust. Funding Information: Conflict of interest: J. d. A. has received grant support from the National Institutes of Health/National Heart, Lung, and Blood Institute; InterMune, Inc; Boehringer Ingelheim GmbH; Genentech, Inc; and Gilead, and has served as consultant for ImmuneWorks; InterMune, Inc; Genentech, Inc; and Boehringer Ingelheim GmbH. H. R. C. is a consultant to the following companies: AstraZeneca/MedImmune LLC; Bayer AG; Biogen Idec; FibroGen, Inc; Genentech, Inc; Genoa Pharmaceuticals; Gilead; GlaxoSmithKline; Mesoblast Ltd; Moerae Matrix; PatientsLikeMe; Pfizer Inc; Promedior, Inc; and ProMetic Life Sciences Inc. H. R. C. has a research contract with Boehringer Ingelheim GmbH. D. L.'s institution and laboratory receives research support from the National Heart, Lung, and Blood Institute; Siemens Corporation; Veracyte, Inc; and PAREXEL. D. L. is a consultant to PAREXEL; Boehringer Ingelheim GmbH; Genentech, Inc; Gilead; and InterMune, Inc. R. J. K. is a consultant to the following companies: AstraZeneca/Medimmune LLC, Boehringer Ingelheim GmbH, Genentech, Inc, Gilead, and Janssen. None declared (M. S., T. G.-B., T. C.). Publisher Copyright: © 2015 American College of Chest Physicians.
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.
UR - http://www.scopus.com/inward/record.url?scp=84943396651&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84943396651&partnerID=8YFLogxK
U2 - 10.1378/chest.14-2889
DO - 10.1378/chest.14-2889
M3 - Article
C2 - 26111071
AN - SCOPUS:84943396651
SN - 0012-3692
VL - 148
SP - 1034
EP - 1042
JO - CHEST
JF - CHEST
IS - 4
ER -