Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

BMJ Open

Volumn 6, Issue 9, 2016, Pages

  Ahmed, Khaled ^a   Kyte, Derek ^a   Keeley, Thomas ^a   Efficace, Fabio ^b   Armes, Jo ^c   Brown, Julia M ^d   Calman, Lynn ^e   Copland, Chris ^f   Gavin, Anna ^g   Glaser, Adam ^h   Greenfield, Diana M ⁱ   Lanceley, Anne ^j   Taylor, Rachel ^k   Velikova, Galina ^d   Brundage, Michael ^l   Mercieca Bebber, Rebecca ^a,m   King, Madeleine T ^m   Calvert, Melanie ^a  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b Health Outcome Research Unit   (Italy)

^c KING'S COLLEGE LONDON   (United Kingdom)

^d UNIVERSITY OF LEEDS   (United Kingdom)

^e UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^f NCRI Psychosocial Oncology and Survivorship CSG   (United Kingdom)

^g QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

^h UNIVERSITY OF LEEDS   (United Kingdom)

ⁱ SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^j UNIVERSITY COLLEGE LONDON   (United Kingdom)

^k UNIVERSITY COLLEGE LONDON HOSPITALS   (United Kingdom)

^l QUEEN S UNIVERSITY   (Canada)

^m UNIVERSITY OF SYDNEY   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CANCER MODEL; CLINICAL RESEARCH; FEMALE; GROUPS BY AGE; HUMAN; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PATIENT-REPORTED OUTCOME; PROFESSIONAL STANDARD; SOCIAL MEDIA;

EID: 85020131107     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/BMJOPEN-2016-012863     Document Type: Article

References (31)

1. Dawson J, Doll H, Fitzpatrick R, et al. The routine use of patient reported outcome measures in healthcare settings. BMJ 2010;340: c186.
2. Ahmed S, Berzon RA, Revicki DA, et al. The use of patient-reported outcomes (PRO) within comparative effectiveness research: implications for clinical practice and health care policy. Med Care 2012;50:1060-70.
3. DoH. Equity and excellence: liberating the NHS. UK: Department of Health, 2011.
4. Ouwens M, Hermens R, Hulscher M, et al. Development of indicators for patient-centred cancer care. Support Care Cancer 2010;18:121-30.
5. FDA. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. 2009. http://wwwfdagov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM193282pdf
6. Higginson IJ, Carr AJ. Measuring quality of life: using quality of life measures in the clinical setting. BMJ 2001;322:1297-300.
7. NICE. Guidance on the use of trastuzumab for the treatment of advanced breast cancer. National Institute for health and care excellence. Technology appraisal guidance [TA34] Published date: 15 March 2002. https://www.nice.org.uk/guidance/ta34
8. EMA. Reflection paper on the use of patient reported outcome (PRO) measures in oncology studies (Draft). European Medicines Agency 2014; Oncology Working Party; Doc. ref. EMA/CHMP/292464/2014.
9. Brundage M, Leis A, Bezjak A, et al. Cancer patients' preferences for communicating clinical trial quality of life information: a qualitative study. Qual Life Res 2003;12:395-404.
10. Davidson BJ, Goldenberg SL, Gleave ME, et al. Provision of individualized information to men and their partners to facilitate treatment decision making in prostate cancer. Oncol Nurs Forum 2003;30:107-14.
11. Au HJ, Ringash J, Brundage M, et al. Added value of health-related quality of life measurement in cancer clinical trials: the experience of the NCIC CTG. Expert Rev Pharmacoecon Outcomes Res 2010;10:119-28.
12. Basch E. Toward patient-centered drug development in oncology. N Engl J Med 2013;369:397-400.
13. Blazeby JM, Avery K, Sprangers M, et al. Health-related quality of life measurement in randomized clinical trials in surgical oncology. J Clin Oncol 2006;24:3178-86.
14. Ford HE, Marshall A, Bridgewater JA, et al. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. Lancet Oncol 2014;15:78-86.
15. Dutton SJ, Ferry DR, Blazeby JM, et al. Gefitinib for oesophageal cancer progressing after chemotherapy (COG): a phase 3, multicentre, double-blind, placebo-controlled randomised trial. Lancet Oncol 2014;15:894-904.
16. Calvert M, Thwaites R, Kyte D, et al. Putting patient-reported outcomes on the 'Big Data Road Map'. J R Soc Med 2015;108:299-303.
17. Chan A, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
18. Brundage M, Bass B, Davidson J, et al. 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;20:653-64.
19. Kyte D, Duffy H, Fletcher B, et al. Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols. PLoS One 2014;9:e110229.
20. Kyte D, Ives J, Draper H, et al. Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists. PLoS One 2013;8:e76625.
21. Schandelmaier S, Conen K, von Elm E, et al. Planning and reporting of quality-of-life outcomes in cancer trials. Ann Oncol 2015;26:1966-73.
22. Efficace F, Fayers P, Pusic A, et al. On behalf of EORTC Quality of Life Group. PROMOTION Registry. Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT PRO extension: a pooled analysis of 557 Trials. Cancer 2015;121:3335-42.
23. Chalmers I, Bracken MB, Djulbegovic B, et al. How to increase value and reduce waste when research priorities are set. Lancet 2014;383:156-65.
24. Nisula S, Yang R, Poukkanen M, et al. Predictive value of urine interleukin-18 in the evolution and outcome of acute kidney injury in critically ill adult patients. Br J Anaesth 2015;114:460-8.
25. PROMOTION. Patient-Reported Outcomes Measurements Over Time In ONcology Fondazione Gimema. 2016 http://promotion.gimema.it/ (accessed Apr 2016).
26. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200-7.
27. Calvert M, Blazeby J, Altman DG, et al. Reporting of patient reported outcomes in randomised trials: the CONSORT PRO extension. JAMA 2013;309:814-22.
28. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med 2010;7:e1000251.
29. Smyth RM, Kirkham JJ, Jacoby A, et al. Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ 2011;342:c7153..
30. Brundage M, Blazeby J, Revicki D, et al. Patient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standards. Qual Life Res 2013;22:1161-75.
31. Babyak MA. What you see may not be what you get: a brief, nontechnical introduction to overfitting in regression-type models. Psychosom Med 2004;66:411-21.