Author Contributions: Drs Calvert and Brundage had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: All authors.
Drafting of the manuscript: All authors.
Critical revision of the manuscript for important intellectual content: All authors.
Obtained funding: Calvert, Blazeby,Revicki, Moher, Brundage.
Study supervision: Calvert, Blazeby, Revicki, and Brundage.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Calvert reported that she has served as a consultant to Amgen. No other disclosures were reported.
The CONSORT PRO Group Contributors to CONSORT PRO Extension/Elaboration 2012: ISOQOL Reporting Guidelines Task Force: Dr Brundage, Queen's University, Kingston, Ontario, Canada (chair): Dr Calvert, University of Birmingham, England; Dr Blazeby, University of Bristol, England; Dr Moher, Ottawa Hospital Research Institute, Ontario; Dr Revicki, Outcomes Research, United Biosource Corp, Bethesda, Maryland; Jane Scott, Patient Reported Outcomes, Janssen Global Services, Manchester, England; Dr Fabio Efficace, GIMEMA, Rome, Italy; Henrica de Vet, PhD, Vrije Universeit Medical Center, the Netherlands; Susan Yount, PhD, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Claire Snyder, PhD, The Johns Hopkins School of Medicine, Baltimore, Maryland; Madeleine King, PhD, University of Sydney, Australia; Cindy Lam, PhD, The University of Hong Kong; Helen Duffy, BA(Hons), University of Birmingham, England; and Brenda Bass, MBA, Queen's University, Kingston, Ontario, Canada.
Funding/Support: This work was supported by the UK Medical Research Council Hubs for Trials Methodology Research and the Canadian Institutes of Health Research. Dr Moher is funded, in part, through a University of Ottawa Research Chair. Dr Altman is supported by grant C5529 from Cancer Research UK. Dr Brundage is supported by a Cancer Care Ontario Research Chair award.
Role of the Sponsor: None of the sponsors had any involvement in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Disclaimer: Robert M. Golub, MD, JAMA Deputy Editor, participated in the CONSORT PRO meeting in London but was not involved in the JAMA editorial evaluation of or decision to publish this article.
Additional Contributions: Members of the CONSORT PRO Group attended the meeting, except for those noted below, and provided input on and review of the revised checklist and text of this article. Dr Altman, Centre for Statistics in Medicine, University of Oxford, Oxford, England; Ethan Basch, MD, Memorial Sloan-Kettering Cancer Center, New York, New York; Peter Davidson, MD, Health Technology Assessment, National Institute for Health Research Evaluation, Trials and Studies Coordination Centre, University of Southampton, England; Michael Drummond, MD, Value in Health, Lawrenceville, NJ; Martin Eccles, MD, School of Population and Health Sciences, Newcastle University, England; Cynthia J. Girman, MD, Department of Epidemiology, University of North Carolina, and Merck Research Laboratories, Chapel Hill; Robert M. Golub, MD, JAMA, Chicago, Illinois; Paul B. Jacobsen, PhD, Journal of Clinical Oncology, Boston, Massachusetts; Astrid James, MD, Lancet, London, England; Xavier Luria, MD, Safety and Efficacy of Medicines, European Medicines Agency, London, England; Donald Patrick, PhD, MSPH, International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville, NJ; Richard Stephens, patient representative, England; Andrew Stevens, National Institute for Health and Clinical Excellence appraisals committee, London, England; Sharon Straus, MD, Knowledge Translation Program, Li Ka Shing, Knowledge Institute, St Michael's Hospital, Toronto, Ontario; Emma Veitch, MD, PLoS Medicine, London, England; Rosalie Viney, MD, Centre for Health Economics Research and Evaluation, University of Technology Sydney, Australia; Deborah Watkins Bruner, MD, Emory University, Atlanta, Georgia. Contributors to CONSORT PRO Extension/Elaboration 2012 who did not attend the London meeting: Trish Groves, MD, BMJ open access, BMJ, London, England; Maria Von Hildebrand, Carer Representative, England.