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@article{Saketkoo:2013:10.1136/thoraxjnl-2013-204202,
author = {Saketkoo, LA and Mittoo, S and Huscher, D and Khanna, D and Dellaripa, PF and Distler, O and Flaherty, KR and Frankel, S and Oddis, CV and Denton, CP and Fischer, A and Kowal-Bielecka, OM and LeSage, D and Merkel, PA and Phillips, K and Pittrow, D and Swigris, J and Antoniou, K and Baughman, RP and Castelino, FV and Christmann, RB and Christopher-Stine, L and Collard, HR and Cottin, V and Danoff, S and Highland, KB and Hummers, L and Shah, AA and Kim, DS and Lynch, DA and Miller, FW and Proudman, SM and Richeldi, L and Ryu, JH and Sandorfi, N and Sarver, C and Wells, AU and Strand, V and Matteson, EL and Brown, KK and Seibold, JR},
doi = {10.1136/thoraxjnl-2013-204202},
journal = {Thorax},
pages = {428--436},
title = {Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials},
url = {http://dx.doi.org/10.1136/thoraxjnl-2013-204202},
volume = {69},
year = {2013}
}

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TY  - JOUR
AB  - 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.
AU  - Saketkoo,LA
AU  - Mittoo,S
AU  - Huscher,D
AU  - Khanna,D
AU  - Dellaripa,PF
AU  - Distler,O
AU  - Flaherty,KR
AU  - Frankel,S
AU  - Oddis,CV
AU  - Denton,CP
AU  - Fischer,A
AU  - Kowal-Bielecka,OM
AU  - LeSage,D
AU  - Merkel,PA
AU  - Phillips,K
AU  - Pittrow,D
AU  - Swigris,J
AU  - Antoniou,K
AU  - Baughman,RP
AU  - Castelino,FV
AU  - Christmann,RB
AU  - Christopher-Stine,L
AU  - Collard,HR
AU  - Cottin,V
AU  - Danoff,S
AU  - Highland,KB
AU  - Hummers,L
AU  - Shah,AA
AU  - Kim,DS
AU  - Lynch,DA
AU  - Miller,FW
AU  - Proudman,SM
AU  - Richeldi,L
AU  - Ryu,JH
AU  - Sandorfi,N
AU  - Sarver,C
AU  - Wells,AU
AU  - Strand,V
AU  - Matteson,EL
AU  - Brown,KK
AU  - Seibold,JR
DO  - 10.1136/thoraxjnl-2013-204202
EP  - 436
PY  - 2013///
SN  - 0040-6376
SP  - 428
TI  - Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials
T2  - Thorax
UR  - http://dx.doi.org/10.1136/thoraxjnl-2013-204202
UR  - http://hdl.handle.net/10044/1/40949
VL  - 69
ER  -

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