Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials. Issue 5 (24th December 2013)

• Record Type: Journal Article
• Authors: Saketkoo, Lesley Ann; Mittoo, Shikha; Huscher, Dörte; Khanna, Dinesh; Dellaripa, Paul F; Distler, Oliver; Flaherty, Kevin R; Frankel, Sid; Oddis, Chester V; Denton, Christopher P; Fischer, Aryeh; Kowal-Bielecka, Otylia M; LeSage, Daphne; Merkel, Peter A; Phillips, Kristine; Pittrow, David; Swigris, Jeffrey; Antoniou, Katerina; Baughman, Robert P; Castelino, Flavia V; Christmann, Romy B; Christopher-Stine, Lisa; Collard, Harold R; Cottin, Vincent; Danoff, Sonye; Highland, Kristin B; Hummers, Laura; Shah, Ami A; Kim, Dong Soon; Lynch, David A; Miller, Frederick W; Proudman, Susanna M; Richeldi, Luca; Ryu, Jay H; Sandorfi, Nora; Sarver, Catherine; Wells, Athol U; Strand, Vibeke; Matteson, Eric L; Brown, Kevin K; Seibold, James R;
• Other Names: Aggarwal* Rohit author non-byline.; Ainslie Gillian author non-byline.; Alkassab Firas author non-byline.; Allanore Yannick author non-byline.; Descartes Paris author non-byline.; Anderson Marina E author non-byline.; Andonopoulos Andrew P author non-byline.; Antin-Ozerkis Danielle author non-byline.; Arrobas Ana author non-byline.; Ascherman* Dana P author non-byline.; Assassi Shervin author non-byline.; Baron Murray author non-byline.; Bathon* Joan M author non-byline.; Behr Juergen author non-byline.; Beretta Lorenzo author non-byline.; Bingham Clifton O author non-byline.; Binnie Matthew author non-byline.; Birring Surinder S author non-byline.; Boin Francesco author non-byline.; Bongartz* Tim author non-byline.; Bourdin Arnaud author non-byline.; Bouros Demosthenes author non-byline.; Brasington Richard author non-byline.; Bresser Paul author non-byline.; Buch Maya H author non-byline.; Burge P Sherwood author non-byline.; Carmona Loreto author non-byline.; Carreira Patricia E author non-byline.; Carvalho Carlos RR author non-byline.; Catoggio Luis J author non-byline.; Chan Kevin M author non-byline.; Chapman Jeffrey author non-byline.; Chatterjee Soumya author non-byline.; Chua* Felix author non-byline.; Chung Lorinda author non-byline.; Conron Matthew author non-byline.; Corte Tamera author non-byline.; Cosgrove Gregory author non-byline.; Costabel Ulrich author non-byline.; Cox Gerard author non-byline.; Crestani Bruno author non-byline.; Crofford Leslie J author non-byline.; Csuka Mary E author non-byline.; Curbelo Pablo author non-byline.; László Czirják author non-byline.; Daniil Zoe author non-byline.; D'Arsigny Christine L author non-byline.; Davis Gerald S author non-byline.; de Andrade Joao A author non-byline.; De Vuyst Paul author non-byline.; Dempsey Owen J author non-byline.; Derk Chris T author non-byline.; Distler Jörg author non-byline.; Dixon* William G author non-byline.; Downey Gregory author non-byline.; Doyle Mittie K author non-byline.; Drent Marjolein author non-byline.; Durairaj Lakshmi author non-byline.; Emery Paul author non-byline.; Espinoza Luis R author non-byline.; Farge Dominique author non-byline.; Fathi Maryam author non-byline.; Fell Charlene D author non-byline.; Fessler Barri J author non-byline.; Fitzgerald John E author non-byline.; Fox George A author non-byline.; Foeldvari Ivan author non-byline.; Frech Tracy M author non-byline.; Freitas Sara author non-byline.; Furst* Daniel E author non-byline.; Gabrielli Armando author non-byline.; García-Vicuña Rosario author non-byline.; Georgiev Ognian B author non-byline.; Gerbino Anthony author non-byline.; Gillisen Adrian author non-byline.; Gladman Dafna D author non-byline.; Glassberg Marilyn author non-byline.; Gochuico Bernadette R author non-byline.; Gogali Athena author non-byline.; Goh* Nicole S author non-byline.; Goldberg Avram author non-byline.; Goldberg Hilary J author non-byline.; Gourley* Mark F author non-byline.; Griffing Leroy author non-byline.; Grutters Jan C author non-byline.; Gunnarsson Ragnar author non-byline.; Hachulla Eric author non-byline.; Hall Frances C author non-byline.; Harari Sergio author non-byline.; Herrick Ariane L author non-byline.; Herzog Erica L author non-byline.; Hesselstrand Roger author non-byline.; Hirani Nikhil author non-byline.; Hodgson Ulla author non-byline.; Hollingsworth Helen M author non-byline.; Homer Robert J author non-byline.; Hoyles Rachel K author non-byline.; Hsu Vivien M author non-byline.; Hubbard Richard B author non-byline.; Hunzelmann Nicolas author non-byline.; Isasi Maria Eloisa author non-byline.; Isasi Elida Susana author non-byline.; Sergio A Jimenez Jacobsen Soren author non-byline.; Johnson Sindhu R author non-byline.; Jones Christine H author non-byline.; Kahaleh Bashar author non-byline.; Kairalla Ronaldo A author non-byline.; Kalluri Meena author non-byline.; Kalra Sanjay author non-byline.; Kaner Robert J author non-byline.; Kinder Brent W author non-byline.; Klingsberg Ross C author non-byline.; Kokosi Maria author non-byline.; RJ Kolb Martin author non-byline.; Kur-Zalewska Joanna author non-byline.; Kuwana* Masataka author non-byline.; Lake Fiona R author non-byline.; Lally Edward V author non-byline.; Lasky Joseph A author non-byline.; Laurindo Ileda M author non-byline.; Able Lawrence author non-byline.; Lee Peter author non-byline.; Leonard Colm T author non-byline.; Lien Dale C author non-byline.; Limper Andrew H author non-byline.; Liossis Stamatis-Nick C author non-byline.; Lohr Kristine M author non-byline.; Loyd James E author non-byline.; Lundberg* Ingrid E author non-byline.; Mageto Yolanda N author non-byline.; Maher Toby M author non-byline.; Mahmud Tafazzul H author non-byline.; Manganas Helene author non-byline.; Marie Isabelle author non-byline.; Marras Theodore K author non-byline.; Antônio Baddini Martinez José author non-byline.; Martinez Fernando J author non-byline.; Mathieu Alessandro author non-byline.; Matucci-Cerinic* Marco author non-byline.; Mayes* Maureen D author non-byline.; McKown Kevin M author non-byline.; Medsger Thomas A author non-byline.; Meehan Richard T author non-byline.; Cristina Mendes Ana author non-byline.; Meyer Keith C author non-byline.; Millar Ann B author non-byline.; Moğulkoç Nesrin author non-byline.; Molitor Jerry A author non-byline.; Morais António author non-byline.; Luc Mouthon Portugal author non-byline.; Müller Veronika author non-byline.; Müller-Quernheim Joachim author non-byline.; Nadashkevich Oleg author non-byline.; Nador Roland author non-byline.; Nash Peter author non-byline.; Nathan Steven D author non-byline.; Navarro Carmen author non-byline.; Neves Sofia author non-byline.; Noth Imre author non-byline.; Nunes Hilario author non-byline.; Olson Amy L. author non-byline.; Opitz Christian F author non-byline.; Padilla Maria author non-byline.; Pappas Dimitrios author non-byline.; Parfrey Helen author non-byline.; Pego-Reigosa José M author non-byline.; AC Pereira Carlos author non-byline.; Perez Rafael author non-byline.; Pope* Janet E author non-byline.; Porter Joanna C. author non-byline.; Renzoni Elisabeth A author non-byline.; Riemekasten Gabriela author non-byline.; Riley David J author non-byline.; Rischmueller Maureen author non-byline.; Rodriguez-Reyna Tatiana S author non-byline.; Rojas-Serrano author non-byline.; Romam Jesse author non-byline.; Rosen Glenn D author non-byline.; Rossman Milton author non-byline.; Rothfield Naomi author non-byline.; Sahn Steven A author non-byline.; Sanduzzi Alessandro author non-byline.; Scholand Mary Beth author non-byline.; Selman Moises author non-byline.; Senécal Jean-Luc author non-byline.; Seo Philip author non-byline.; Silver* Richard M author non-byline.; Solomon Joshua J author non-byline.; Steen* Virginia author non-byline.; Stevens Wendy author non-byline.; Strange Charlie author non-byline.; Sussman Robert author non-byline.; Sutton Evelyn D author non-byline.; Sweiss Nadera J author non-byline.; Tornling Göran author non-byline.; Tzelepis George E author non-byline.; Undurraga Alvaro author non-byline.; Vacca Allessandra author non-byline.; Vancheri Carlo author non-byline.; Varga Janos author non-byline.; Veale Douglas J author non-byline.; Volkov Suncica author non-byline.; Walker Ulrich A author non-byline.; Wencel Mark author non-byline.; Wesselius Lewis J author non-byline.; Wickremasinghe Melissa author non-byline.; Wilcox Pearce author non-byline.; Wilsher Margaret L author non-byline.; Wollheim Frank A author non-byline.; Wuyts Wim A author non-byline.; Yung Gordon author non-byline.; Zanon Pietro author non-byline.; Zappala Christopher J author non-byline.; Groshong Steve D author non-byline.; Leslie Kevin O author non-byline.; Myers Jeffrey L author non-byline.; Padera Robert F author non-byline.; R Desai Sujal author non-byline.; Goldin Jonathan author non-byline.; Kazerooni Ella A author non-byline.; Klein Jeffrey S author non-byline.; Lynch David A author non-byline.; Keen Kevin J author non-byline.;
• Is Part Of: Thorax. Volume 69:Issue 5(2014)
• Page Start: 436
• Page End: 444
• Publication Date: 2013-12-24
• Subjects: Connective tissue disease associated lung disease -- Interstitial Fibrosis -- Idiopathic pulmonary fibrosis -- Rheumatoid lung disease -- Systemic disease and lungs; Chest -- Diseases -- Periodicals; Thorax; Chest -- Diseases; Periodicals; Periodicals; 617.54
• DOI: 10.1136/thoraxjnl-2013-204202
• Languages: English
• ISSNs: 0040-6376

Abstract

Abstract : Rationale: Clinical trial design in interstitial lung diseases (ILDs) has been hampered by lack of consensus on appropriate outcome measures for reliably assessing treatment response. In the setting of connective tissue diseases (CTDs), some measures of ILD disease activity and severity may be confounded by non-pulmonary comorbidities. Methods: The Connective Tissue Disease associated Interstitial Lung Disease (CTD-ILD) working group of Outcome Measures in Rheumatology—a non-profit international organisation dedicated to consensus methodology in identification of outcome measures—conducted a series of investigations which included a Delphi process including >248 ILD medical experts as well as patient focus groups culminating in a nominal group panel of ILD experts and patients. The goal was to define and develop a consensus on the status of outcome measure candidates for use in randomised controlled trials in CTD-ILD and idiopathic pulmonary fibrosis (IPF). Results: A core set comprising specific measures in the domains of lung physiology, lung imaging, survival, dyspnoea, cough and health-related quality of life is proposed as appropriate for consideration for use in a hypothetical 1-year multicentre clinical trial for either CTD-ILD or IPF. As many widely used instruments were found to lack full validation, an agenda for future research is proposed. Conclusion: Identification of consensus preliminary domains and instruments to measure them was attained and is a major advance anticipated to facilitate multicentre RCTs in the field.