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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2013

Open Access 01-12-2013 | Review

The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice

Authors: Melanie Calvert, Michael Brundage, Paul B Jacobsen, Holger J Schünemann, Fabio Efficace

Published in: Health and Quality of Life Outcomes | Issue 1/2013

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Abstract

To inform clinical guidelines and patient care we need high quality evidence on the relative benefits and harms of intervention. Patient reported outcome (PRO) data from clinical trials can “empower patients to make decisions based on their values” and “level the playing field between physician and patient”. While clinicians have a good understanding of the concept of health-related quality of life and other PROs, evidence suggests that many do not feel comfortable in using the data from trials to inform discussions with patients and clinical practice. This may in part reflect concerns over the integrity of the data and difficulties in interpreting the results arising from poor reporting.
The new CONSORT PRO extension aims to improve the reporting of PROs in trials to facilitate the use of results to inform clinical practice and health policy. While the CONSORT PRO extension is an important first step in the process, we need broader engagement with the guidance to facilitate optimal reporting and maximize use of PRO data in a clinical setting. Endorsement by journal editors, authors and peer reviewers are crucial steps. Improved design, implementation and transparent reporting of PROs in clinical trials are necessary to provide high quality evidence to inform evidence synthesis and clinical practice guidelines.
Appendix
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Literature
1.
Sanders C, Egger M, Donovan J, Tallon D, Frankel S: Reporting on quality of life in randomised controlled trials: bibliographic study. BMJ 1998, 317: 1191–1194. 10.1136/bmj.317.7167.1191PubMedCentralPubMedCrossRef
2.
US Food and Drug Administration: Guidance for Industry: Patient-reported outcome measures: use in medical product development to support labeling claims. U.S. Department of health and human services food and drug administration. 2009.
3.
Till JE, Osoba D, Pater JL, Young JR: Research on health-related quality of life: dissemination into practical applications. Qual Life Res 1994, 3: 279–283. 10.1007/BF00434902PubMedCrossRef
4.
Chassany O, Sagnier P, Marquis P, Fullerton S, Aaronson N: Patient-reported outcomes: the example of health related quality of life-a European guidance document for the improved integration of health related quality of life assessment in the drug regulatory process. Drug Inf J 2002, 36: 209–238. 10.1177/009286150203600127CrossRef
5.
Brundage M, Bass B, Jolie R, Foley K: A knowledge translation challenge: clinical use of quality of life data from cancer clinical trials. Qual Life Res 2011, 20: 979–985. 10.1007/s11136-011-9848-0PubMedCrossRef
6.
Efficace F, Osoba D, Gotay C, Sprangers M, Coens C, Bottomley A: Has the quality of health-related quality of life reporting in cancer clinical trials improved over time? Towards bridging the gap with clinical decision making. Ann Oncol 2007, 18: 775–781.PubMedCrossRef
7.
Brundage M, Bass B, Davidson J, Queenan J, Bezjak A, Ringash J, Wilkinson A, Feldman-Stewart D: Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers. Qual Life Res 2011, 20: 653–664. 10.1007/s11136-010-9793-3PubMedCrossRef
8.
Efficace F, Bottomley A, Osoba D, Gotay C, Flechtner H, D’Haese S, Zurlo A: Beyond the development of health-related quality-of-life (HRQOL) measures: a checklist for evaluating HRQOL outcomes in cancer clinical trials–does HRQOL evaluation in prostate cancer research inform clinical decision making? J Clin Oncol 2003, 21: 3502–3511. 10.1200/JCO.2003.12.121PubMedCrossRef
9.
Bottomley A, Therasse P: Quality of life in patients undergoing systemic therapy for advanced breast cancer. Lancet Oncol 2002, 3: 620–628. 10.1016/S1470-2045(02)00876-8PubMedCrossRef
10.
Efficace F, Bottomley A, van Andel G: Health related quality of life in prostate carcinoma patients: a systematic review of randomized controlled trials. Cancer 2003, 97: 377–388. 10.1002/cncr.11065PubMedCrossRef
11.
Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD: Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 2013, 309: 814–822. 10.1001/jama.2013.879PubMedCrossRef
12.
Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, Dias S, Schulz KF, Plint AC, Moher D: Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev 2012., 11: MR000030
13.
14.
15.
Brundage M, Blazeby J, Revicki D, Bass B, de Vet H, Duffy H, Efficace F, King M, Lam CL, Moher D, et al.: Patient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standards. Qual Life Res 2013, 22: 1161–1175. 10.1007/s11136-012-0252-1PubMedCentralPubMedCrossRef
16.
Hopewell S, Altman DG, Moher D, Schulz KF: Endorsement of the CONSORT statement by high impact factor medical journals: a survey of journal editors and journal ‘Instructions to Authors’. Trials 2008, 9: 20. 10.1186/1745-6215-9-20PubMedCentralPubMedCrossRef
17.
Hopewell S, Ravaud P, Baron G, Boutron I: Effect of editors’ implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis. BMJ 2012, 344: e4178. 10.1136/bmj.e4178PubMedCentralPubMedCrossRef
18.
Kerner JF, Guirguis-Blake J, Hennessy KD, Brounstein PJ, Vinson C, Schwartz RH, Myers BA, Briss P: Translating research into improved outcomes in comprehensive cancer control. Cancer Causes Control 2005,16(Suppl 1):27–40.PubMedCrossRef
19.
Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD: Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR good research practices for evaluating and documenting content validity for the Use of existing instruments and their modification PRO task force report. Value Health 2009, 12: 1075–1083. 10.1111/j.1524-4733.2009.00603.xPubMedCrossRef
20.
Efficace F, Feuerstein M, Fayers P, Cafaro V, Eastham J, Pusic A, Blazeby J, EORTC Quality of Life Group (Patient Reported Outcome Measurements Over Time In ONcology-PROMOTION Project): Patient-reported outcomes in randomized controlled trials of prostate cancer: methodological quality and impact on clinical-decision-making. Eur Urol 2013. in press
21.
Fayers P, Hays R: Assessing quality of life in clinical trials. New York: Oxford University Press; 2005.
22.
Al-Marzouki S, Roberts I, Evans S, Marshall T: Selective reporting in clinical trials: analysis of trial protocols accepted by the lancet. Lancet 2008, 372: 201.PubMedCrossRef
23.
World health organization. Guidelines for development of WHO guidelines 2003.
24.
Atkins D, Eccles M, Flottorp S, Guyatt GH, Henry D, Hill S, Liberati A, O’Connell D, Oxman AD, Phillips B, et al.: Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches the GRADE working group. BMC Health Serv Res 2004, 4: 38. 10.1186/1472-6963-4-38PubMedCentralPubMedCrossRef
25.
Guyatt GH, Oxman AD, Kunz R, Falck-Ytter Y, Vist GE, Liberati A, Schünemann HJ, GRADE Working Group: Rating quality of evidence and strength of recommendations: going from evidence to recommendations. BMJ 2008, 336: 1049–1051. 10.1136/bmj.39493.646875.AEPubMedCentralPubMedCrossRef
26.
Qaseem A, Forland F, Macbeth F, Ollenschlager G, Phillips S, van der Wees P: Guidelines international network: toward international standards for clinical practice guidelines. Ann Intern Med 2012, 156: 525–531. 10.7326/0003-4819-156-7-201204030-00009PubMedCrossRef
27.
IOM (Institute-of-Medicine): Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press; 2011.
Metadata
Title
The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice
Authors
Melanie Calvert
Michael Brundage
Paul B Jacobsen
Holger J Schünemann
Fabio Efficace
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2013
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-11-184

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