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

Author:

Efficace Fabio1,Fayers Peter2,Pusic Andrea3,Cemal Yeliz3,Yanagawa Jane4,Jacobs Marc5,la Sala Andrea6,Cafaro Valentina1,Whale Katie7,Rees Jonathan7,Blazeby Jane7,

Affiliation:

1. Data Center and Health Outcomes Research Unit; Italian Group for Adult Hematologic Diseases; Rome Italy

2. Institute of Applied Health Sciences; University of Aberdeen; Aberdeen United Kingdom

3. Department of Surgery; Memorial Sloan Kettering Cancer Center; New York New York

4. Department of Surgery; David Geffen School of Medicine, University of California Los Angeles; Los Angeles California

5. Department of Medical Psychology; Academic Medical Center/University of Amsterdam; Amsterdam The Netherlands

6. Laboratory of Molecular and Cellular Immunology; Scientific Hospitalization and Care Institution San Raffaele Pisana; Rome Italy

7. Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol; Bristol United Kingdom

Funder

European Organisation for Research and Treatment of Cancer (EORTC), Quality of Life Group

Publisher

Wiley

Subject

Cancer Research,Oncology

Reference24 articles.

1. Clinical Cancer Advances 2013: annual report on progress against cancer from the American Society of Clinical Oncology;Patel;J Clin Oncol.,2014

2. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation;Moher;JAMA.,2001

3. Improving the quality of reporting of randomized controlled trials. The CONSORT statement;Begg;JAMA.,1996

4. Consolidated Standards of Reporting Trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals;Turner;Cochrane Database Syst Rev.,2012

5. US Food and Drug Administration Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf

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