Reporting Standards for Patient-Reported Outcomes in Clinical Trial Protocols and Publications

被引:8
作者
Basch, Ethan [1 ]
Leahy, Allison Barz [2 ]
机构
[1] Univ N Carolina, Lineberger Comprehens Canc Ctr, Canc Outcomes Res Program, Chapel Hill, NC 27515 USA
[2] Childrens Hosp Philadelphia, Div Oncol, Philadelphia, PA 19104 USA
来源
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE | 2019年 / 111卷 / 11期
关键词
D O I
10.1093/jnci/djz047
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
引用
收藏
页码:1116 / 1117
页数:2
相关论文
共 8 条
[1]   High Compliance Rates With Patient-Reported Outcomes in Oncology Trials Submitted to the US Food and Drug Administration [J].
Basch, Ethan .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2019, 111 (05) :437-439
[2]   Methodological Standards and Patient-Centeredness in Comparative Effectiveness Research The PCORI Perspective [J].
Basch, Ethan ;
Aronson, Naomi ;
Berg, Alfred ;
Flum, David ;
Gabriel, Sherine ;
Goodman, Steven N. ;
Helfand, Mark ;
Ioannidis, John P. A. ;
Lauer, Michael ;
Meltzer, David ;
Mittman, Brian ;
Newhouse, Robin ;
Normand, Sharon-Lise ;
Schneeweiss, Sebastian ;
Slutsky, Jean ;
Tinetti, Mary ;
Yancy, Clyde .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2012, 307 (15) :1636-1640
[3]   Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials [J].
Bottomley, Andrew ;
Pe, Madeline ;
Sloan, Jeff ;
Basch, Ethan ;
Bonnetain, Franck ;
Calvert, Melanie ;
Campbell, Alicyn ;
Cleeland, Charles ;
Cocks, Kim ;
Collette, Laurence ;
Dueck, Amylou C. ;
Devlin, Nancy ;
Flechtner, Hans-Henning ;
Gotay, Carolyn ;
Greimel, Eva ;
Griebsch, Ingolf ;
Groenvold, Mogens ;
Hamel, Jean-Francois ;
King, Madeleine ;
Kluetz, Paul G. ;
Koller, Michael ;
Malone, Daniel C. ;
Martinelli, Francesca ;
Mitchell, Sandra A. ;
Moinpour, Carol M. ;
Musoro, Jammbe Z. ;
O'Connor, Daniel ;
Oliver, Kathy ;
Piault-Louis, Elisabeth ;
Piccart, Martine ;
Pimentel, Francisco L. ;
Quinten, Chantal ;
Reijneveld, Jaap C. ;
Schuermann, Christoph ;
Smith, Ashley Wilder ;
Soltys, Katherine M. ;
Sridhara, Rajeshwari ;
Taphoorn, Martin J. B. ;
Velikova, Galina ;
Coens, Corneel .
CLINICAL TRIALS, 2018, 15 (06) :624-630
[4]   Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols The SPIRIT-PRO Extension [J].
Calvert, Melanie ;
Kyte, Derek ;
Mercieca-Bebber, Rebecca ;
Slade, Anita ;
Chan, An-Wen ;
King, Madeleine T. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2018, 319 (05) :483-494
[5]   Reporting of Patient-Reported Outcomes in Randomized Trials The CONSORT PRO Extension [J].
Calvert, Melanie ;
Blazeby, Jane ;
Altman, Douglas G. ;
Revicki, Dennis A. ;
Moher, David ;
Brundage, Michael D. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2013, 309 (08) :814-822
[6]   Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials [J].
Efficace, Fabio ;
Fayers, Peter ;
Pusic, Andrea ;
Cemal, Yeliz ;
Yanagawa, Jane ;
Jacobs, Marc ;
la Sala, Andrea ;
Cafaro, Valentina ;
Whale, Katie ;
Rees, Jonathan ;
Blazeby, Jane .
CANCER, 2015, 121 (18) :3335-3342
[7]   Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms [J].
Kluetz, Paul G. ;
Slagle, Ashley ;
Papadopoulos, Elektra J. ;
Johnson, Laura Lee ;
Donoghue, Martha ;
Kwitkowski, Virginia E. ;
Chen, Wen-Hung ;
Sridhara, Rajeshwari ;
Farrell, Ann T. ;
Keegan, Patricia ;
Kim, Geoffrey ;
Pazdur, Richard .
CLINICAL CANCER RESEARCH, 2016, 22 (07) :1553-1558
[8]   Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials [J].
Kyte, Derek ;
Retzer, Ameeta ;
Ahmed, Khaled ;
Keeley, Thomas ;
Armes, Jo ;
Brown, Julia M. ;
Calman, Lynn ;
Gavin, Anna ;
Glaser, Adam W. ;
Greenfield, Diana M. ;
Lanceley, Anne ;
Taylor, Rachel M. ;
Velikova, Galina ;
Brundage, Michael ;
Efficace, Fabio ;
Mercieca-Bebber, Rebecca ;
King, Madeleine T. ;
Turner, Grace ;
Calvert, Melanie .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2019, 111 (11) :1170-1178