jane blazebyProfessional title: Professor of Surgery

Date of primary qualification: 1988

Current institution: University of Bristol, UK

Title of invited presentation:
The need for consensus, consistency and core outcome sets in clinical trials

Learning objectives:
The overall aim of this presentation is to demonstrate the need for the use of core outcome sets in clinical trials. The problems associated with outcome reporting in trials will be described, including inconsistent selection of measures which limits data synthesis and comparison and problems with selective outcome reporting leading to outcome reporting bias and incorrect estimates of treatment effect. A solution to these problems will be presented, with the recommendation for the development and wide spread use of core outcome sets in clinical trials. Core outcome sets are an agreed set of outcomes to be reported as a minimum in all trials of particular clinical conditions. Methods to develop core outcome sets will be presented and this will all be illustrated with examples from surgical oncology.


Summary of clinical/research background

Jane Blazeby is Professor of Surgery at the University of Bristol and an Honorary Consultant Upper GI Surgeon at University Hospitals Bristol NHS Foundation Trust. She studied Medicine at Bristol University and undertook higher surgical training in the South West of England before gaining a honorary consultant post and a prestigious MRC Clinician Scientist award in 2000.

Jane has led many methodological research projects to improve the evaluation of surgical interventions from the perspective of the patient as well as the surgeon. She directs a UK MRC Hub for Trials Methodology Research, the new Royal College of Surgeons of England Bristol Surgical Trials Centre and is the chief investigator of three RCTs in surgery. She believes that effective collaboration between surgeons and methodologists will improve the design and conduct of research in surgery which will contribute to raising standards of surgical practice world wide.

Relevant peer reviewed publications within last 5 years

Jane has published over 130 peer reviewed papers. Key recent ones are listed below.

  • Gujral S, Avery K, Blazeby JM. Quality of life after surgery for colorectal cancer: clinical implications of results from randomised trials. Support Care Cancer. 2008, Feb; 16(2): 127-132. Epub 2007, Nov 20. (doi:10.1007/s00520-007-0356-2). (ISSN: 0941-4355). (IRIS No. 113189). (PMID: 18026999).
  • King PM, Blazeby JM, Ewings P, Kenndy RH. Detailed evaluation of functional recovery following laparoscopic or open surgery for colorectal cancer within an enhanced recovery programme. Int J Colorectal Dis. 2008, Aug; 23(8): 795-800. Epub 2008, May 9. (doi:10.1007/s00384-008-0478-0). (ISSN: 0179-1958). (IRIS No. 113649). (PMID: 18465136).
  • Wood JJ, Metcalfe C, Paes A, Sylvester P, Durdey P, Thomas MG, Blazeby JM. An evaluation of treatment decisions at a colorectal cancer multi-disciplinary team. Colorectal Dis. 2008, Oct; 10: 769-772 (doi: 10.1111/j.1463-1318.2007.01464.x). (ISSN: 14628910). (IRIS No. 113187). (PMID: 18215197).
  • Blazeby JM, Fayers P, Conroy T, Sezer O, Ramage J, Rees M on behalf of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Group. Validation of the European Organisation for Research and Treatment of Cancer QLQ-LMC21 questionnaire for assessment of patient-reported outcomes during treatment of colorectal liver metastases. Br J Surg. 2009, Mar; 96: 291-298 (IRIS No. 122838). (PMID: 19224519).
  • Ergina PL, Cook JA, Blazeby JM, et al. Challenges in evaluating surgical innovation. Lancet. 2009, 26 Sep; 374(9695):1097-104. (doi:10.1016/S0140-6736(09)61086-2).
  • Green CJ, Maxwell R, Verne J, Martin RM, Blazeby JM. The Influence of NICE guidance on the uptake of laparoscopic surgery for colorectal surgery. J Public Health (Oxf). 2009, Dec; 31(4): 541-5. Epub 2009, 25 Mar. (doi:10.109, fdp027). (ISSN: 1741-3842). (IRIS No. 122834). (PMID: 19321518).
  • Rutegård M, Hughes R, Lagergren P, Blazeby JM. Determinants of global quality of life before and after major cancer surgery: an exploratory study. Qual Life Res. 2009, Nov; 18(9):1131-6. Epub 2009, Sep 10. (doi:10.1007/s11136-009-9534-7). (ISSN: 0962-9343). (PMID: 19757188).
  • Whistance RN, Conroy T, Chie W, Costantini A, Sezer O, Koller M, Johnson CD, Pilkington SA, Arraras J, Ben-Josef E, Pullyblank AM, Fayers P, Blazeby JM. European Organisation for the Research and Treatment of Cancer Quality of Life Group. Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer. 2009, Nov; 45(17):3017-26. Epub 2009 Sep 16. (doi:10.1016/j.ejca.2009.08.014). (ISSN: 09598049). (IRIS No. 122830). (PMID: 19765978).
  • Blazeby JM, Soulsby M, Winstone K, King PM, Bulley S, Kennedy RH. A qualitative evaluation of patients' experiences of an enhanced recovery programme for colorectal cancer. Colorectal Dis. 2010 Oct; 12(10 Online):e236-42. (doi:10.1111/j.1463-1318.2009.02104.x). (ISSN: 14628910). (IRIS No. 123588). (PMID: 19888959).
  • Davis CR, McNair AG, Brigic A, Clarke MG, Brookes ST, Thomas MG, Blazeby JM. Optimising methods for communicating survival data to patients undergoing cancer surgery. Eur J Cancer. 2010, Dec; 46(18):3192-9. Epub 2010, Aug 19. (doi:10.1016/j.ejca.2010.07.030). (ISSN: 09598045). (IRIS No. 127491). (PMID: 20728342).
  • McNair AG, Brookes ST, Davis CR, Argyropoulos M, Blazeby JM. Communicating the results of randomised clinical trials: do patients understand multi-dimensional patient-reported outcomes? J Clin Oncol. 2010, 10 Feb; 28(5):738-43. Epub 2010, Jan 11. (IRIS No. 122819). (PMID: 20065187).
  • Whistance RN, Gilbert R, Fayers P, Longman RJ, Pullyblank A, Thomas M, Blazeby JM. Assessment of body image in patients undergoing surgery for colorectal cancer. Int J Colorectal Dis. 2010, Mar; 25(3):369-74. Epub 2009, Dec 2. (doi:10.1007/s00384-009-0851-7). (ISSN: 0179-1958). (IRIS No. 123586). (PMID: 19953257).
  • Kennedy RH, Francis A, Dutton S, Love S, Pearson S, Blazeby JM, Quirke P, Franks PJ, Kerr DJ. EnROL: A multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme. BMC Cancer. 2012 May 16;12(1):181. [Epub ahead of print] (PMID: 22591460).
  • Rees JR, Blazeby JM, Fayers P, Friend EA, Welsh FK, John TG, Rees M. Patient-reported outcomes after hepatic resection of colorectal cancer metastases. J Clin Oncol. 2012 Apr 20;30(12):1364-70.
  • Law CW, Roslani AC, Moy FM, Blazeby JM, Sagap I, Zakaria J. Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol. BMC Cancer. 2012 Sep 3;12(1):384. [Epub ahead of print] (PMID: 22937765).
  • Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD; CONSORT PRO Group. JAMA. 2013 Feb 27;309(8):814-22. doi: 10.1001/jama.2013.879.
  • Feasibility study of analgesia via epidural versus continuous wound infusion after laparoscopic colorectal resection. Boulind CE, Ewings P, Bulley SH, Reid JM, Jenkins JT, Blazeby JM, Francis NK. Br J Surg. 2013 Feb;100(3):395-402. doi: 10.1002/bjs.8999. Epub 2012 Dec 19.
  • Integration of clinical and patient-reported outcomes in surgical oncology. Macefield RC, Avery KN, Blazeby JM. Br J Surg. 2013 Jan;100(1):28-37. doi: 10.1002/bjs.8989. Epub 2012 Nov 20. Review.
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