Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension - PubMed (original) (raw)
Guideline
. 2013 Feb 27;309(8):814-22.
doi: 10.1001/jama.2013.879.
Collaborators, Affiliations
- PMID: 23443445
- DOI: 10.1001/jama.2013.879
Guideline
Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension
Melanie Calvert et al. JAMA. 2013.
Abstract
The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the reporting of randomized controlled trials (RCTs); however, it lacks guidance on the reporting of patient-reported outcomes (PROs), which are often inadequately reported in trials, thus limiting the value of these data. In this article, we describe the development of the CONSORT PRO extension based on the methodological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network. Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points. These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract, that a description of the hypothesis of the PROs and relevant domains be provided (ie, if a multidimensional PRO tool has been used), that evidence of the PRO instrument's validity and reliability be provided or cited, that the statistical approaches for dealing with missing data be explicitly stated, and that PRO-specific limitations of study findings and generalizability of results to other populations and clinical practice be discussed. Examples and an updated CONSORT flow diagram with PRO items are provided. It is recommended that the CONSORT PRO guidance supplement the standard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes. Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care.
Comment in
- Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.
Patrick D. Patrick D. Value Health. 2013 Jun;16(4):455-6. doi: 10.1016/j.jval.2013.04.001. Value Health. 2013. PMID: 23796277 No abstract available.
Similar articles
- Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension.
Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, Moher D; CONSORT-SPI Group. Montgomery P, et al. Trials. 2018 Jul 31;19(1):407. doi: 10.1186/s13063-018-2733-1. Trials. 2018. PMID: 30060754 Free PMC article. - 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.
Efficace F, Fayers P, Pusic A, Cemal Y, Yanagawa J, Jacobs M, la Sala A, Cafaro V, Whale K, Rees J, Blazeby J; European Organization for Research and Treatment of Cancer Quality-of-Life Group (Patient-Reported Outcome Measurements Over Time in Oncology Registry). Efficace F, et al. Cancer. 2015 Sep 15;121(18):3335-42. doi: 10.1002/cncr.29489. Epub 2015 Jun 16. Cancer. 2015. PMID: 26079197 Free PMC article. - CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials.
Grant S, Mayo-Wilson E, Montgomery P, Macdonald G, Michie S, Hopewell S, Moher D; , on behalf of the CONSORT-SPI Group. Grant S, et al. Trials. 2018 Jul 31;19(1):406. doi: 10.1186/s13063-018-2735-z. Trials. 2018. PMID: 30060763 Free PMC article. - Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement.
Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Piaggio G, et al. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802. JAMA. 2012. PMID: 23268518 - Quality of patient-reported outcome reporting according to the CONSORT statement in randomized controlled trials with glioblastoma patients.
Garnier L, Charton E, Falcoz A, Paget-Bailly S, Vernerey D, Jary M, Ducray F, Curtit E. Garnier L, et al. Neurooncol Pract. 2020 Nov 11;8(2):148-159. doi: 10.1093/nop/npaa074. eCollection 2021 Apr. Neurooncol Pract. 2020. PMID: 33898048 Free PMC article.
Cited by
- Translation and cultural adaptation of the COVID-19 Yorkshire Rehabilitation Scale into German.
Sperl L, Stamm T, Mosor E, Ritschl V, Sivan M, Hoffmann K, Gantschnig B. Sperl L, et al. Front Med (Lausanne). 2024 Aug 30;11:1401491. doi: 10.3389/fmed.2024.1401491. eCollection 2024. Front Med (Lausanne). 2024. PMID: 39296896 Free PMC article. - Nutritional assessment and medical dietary therapy for management of obesity in patients with non-dialysis chronic kidney disease: a practical guide for endocrinologist, nutritionists and nephrologists. A consensus statement from the Italian society of endocrinology (SIE), working group of the club nutrition-hormones and metabolism; the Italian society of nutraceuticals (SINut), club ketodiets and nutraceuticals "KetoNut-SINut"; and the Italian society of nephrology (SIN).
Annunziata G, Caprio M, Verde L, Carella AM, Camajani E, Benvenuto A, Paolini B, De Nicola L, Aucella F, Bellizzi V, Barberi S, Grassi D, Fogacci F, Colao A, Cicero AFG, Prodam F, Aimaretti G, Muscogiuri G, Barrea L. Annunziata G, et al. J Endocrinol Invest. 2024 Sep 18. doi: 10.1007/s40618-024-02446-8. Online ahead of print. J Endocrinol Invest. 2024. PMID: 39292364 - Efficacy of Food Supplement Based on Monacolins, γ-Oryzanol, and γ-Aminobutyric Acid in Mild Dyslipidemia: A Randomized, Double-Blind, Parallel-Armed, Placebo-Controlled Clinical Trial.
De Lellis LF, Morone MV, Buccato DG, Cordara M, Larsen DS, Ullah H, Piccinocchi R, Piccinocchi G, Balaji P, Baldi A, Di Minno A, El-Seedi HR, Sacchi R, Daglia M. De Lellis LF, et al. Nutrients. 2024 Sep 4;16(17):2983. doi: 10.3390/nu16172983. Nutrients. 2024. PMID: 39275298 Free PMC article. Clinical Trial. - Data collection methods for patient-reported outcome measures in cancer randomised controlled trials: a protocol for a rapid scoping review.
Lehmann J, Krepper D, Pe M, Kuliś D, Giesinger JM, Sztankay M, Kern S, Fitzsimmons D, Holzner B; EORTC Quality of Life Group. Lehmann J, et al. BMJ Open. 2024 Sep 10;14(9):e084935. doi: 10.1136/bmjopen-2024-084935. BMJ Open. 2024. PMID: 39260865 Free PMC article. - Methodology for the selection and evaluation of outcomes for Chinese herbal injection in acute exacerbation of chronic obstructive pulmonary disease (AECOPD): a comprehensive study.
Kong Z, Yang SH, Zhao H, Hao XW, Zhang TW, Lu Y. Kong Z, et al. Ann Med. 2024 Dec;56(1):2396567. doi: 10.1080/07853890.2024.2396567. Epub 2024 Sep 10. Ann Med. 2024. PMID: 39253851 Free PMC article. Review.
Publication types
MeSH terms
Grants and funding
- G0800808/MRC_/Medical Research Council/United Kingdom
- MR/J004871/1/MRC_/Medical Research Council/United Kingdom
- C5529/CRUK_/Cancer Research UK/United Kingdom
- CAPMC/ CIHR/Canada
LinkOut - more resources
Full Text Sources
Other Literature Sources
Miscellaneous