Journal article

Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: The SPIRIT-PRO Extension

Abstract:: Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for ... Expand abstract
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Publication status:: Published

Peer review status:: Peer reviewed

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APA Style

Calvert, M., Kyte, D., Mercieca-Bebber, R., Slade, A., Chan, A., King, M., & the SPIRIT-PRO Group. (2018). Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: The SPIRIT-PRO Extension. Journal of the American Medical Association, 319(5), 483–494.

MLA Style

Calvert, M., et al. “Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.” Journal of the American Medical Association, vol. 319, no. 5, American Medical Association, 2018, pp. 483–94.

Chicago Style

Calvert, M, D Kyte, R Mercieca-Bebber, A Slade, A Chan, M King, and the SPIRIT-PRO Group. 2018. “Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.” Journal of the American Medical Association 319 (5): 483–94.
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Publisher copy:: 10.1001/jama.2017.21903

Authors

+ Calvert, M More by this author

Role:: Author

+ Kyte, D More by this author

Role:: Author

+ Mercieca-Bebber, R More by this author

Role:: Author

+ Slade, A More by this author

Role:: Author

+ Chan, A More by this author

Role:: Author

More authors...

Contributors

Institution:: University of Oxford
Division:: MSD
Department:: NDORMS
Sub department:: Centre for Statistics in Medicine
Role:: Contributor

+ Macmillan Cancer Support More from this funder

Grant:: 5592105

+ University of Birmingham More from this funder

Publisher:: American Medical Association
Journal:: Journal of the American Medical Association More from this journal
Volume:: 319
Issue:: 5
Pages:: 483-494
Publication date:: 2018-02-06
Acceptance date:: 2018-01-03
DOI:: 10.1001/jama.2017.21903
EISSN:: 1538-3598
ISSN:: 0098-7484

Pubs id:: pubs:819314
UUID:: uuid:e87d611a-1cd6-4aa5-8b82-6f45accf42f6
Local pid:: pubs:819314
Source identifiers:: 819314
Deposit date:: 2018-01-12

Terms of use

Copyright holder:: American Medical Association
Copyright date:: 2018
Notes:: Copyright © 2018 American Medical Association.

Licence:: Terms and Conditions of Use for Oxford University Research Archive

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