SEARCH

SEARCH BY CITATION

References

  • 1
    US Department of Health and Human Services Food and Drug Administration. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims; 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM193282.pdf [accessed 24 August 2012].
  • 2
    Sneeuw KCA, Sprangers MA, Aaronson NK. The role of health care providers and significant others in evaluating the quality of life of patients with chronic disease. J Clin Epidemiol 2002; 55: 11301143.
  • 3
    National Cancer Institute of Canada Clinical Trials Group. http://www.ctg.queensu.ca [accessed 21 August 2012].
  • 4
    European Organization for Research and Treatment of Cancer. http://www.eortc.org [accessed 24 August 2012].
  • 5
    UK Medical Research Council. http://www.mrc.ac.uk/index.htm [accessed 24 August 2012].
  • 6
    Sanderson T, Morris M, Calnan M, Richards P, Hewlett S. What outcomes from pharmacologic treatments are important to people with rheumatoid arthritis? Creating the basis of a patient core set. Arthritis Care Res (Hoboken) 2010; 62: 640646.
  • 7
    Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365376.
  • 8
    Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality-of-life. Ann Intern Med 1993; 118: 622629.
  • 9
    Blazeby JM, Avery K, Sprangers M, Pikhart H, Fayers P, Donovan J. Health-related quality of life measurement in randomized clinical trials in surgical oncology. J Clin Oncol 2006; 24: 31783186.
  • 10
    Macefield RC, McNair GK, Blencowe NS, Brookes ST, Blazeby JM. Incorporating patient reported outcomes (PROs) in gastro-intestinal (GI) cancer randomised controlled trials (RCTs): the need for adequate rationale and integrated reporting. Trials 2011; 12(Suppl 1): A76.
  • 11
    Somani BK, Gimlin D, Fayers P, N'Dow J. Quality of life and body image for bladder cancer patients undergoing radical cystectomy and urinary diversion—a prospective cohort study with a systematic review of literature. Urology 2009; 74: 11381143.
  • 12
    Lemieux J, Goodwin PJ, Bordeleau LJ, Lauzier S, Théberge V. Quality-of-life measurement in randomized clinical trials in breast cancer: an updated systematic review (2001–2009). J Natl Cancer Inst 2011; 103: 178231.
  • 13
    Goodwin PJ, Black JT, Bordeleau LJ, Ganz PA. Health-related quality-of-life measurement in randomized clinical trials in breast cancer—taking stock. J Natl Cancer Inst 2003; 95: 263281.
  • 14
    Winters ZE, Benson JR, Pusic AL. A systematic review of the clinical evidence to guide treatment recommendations in breast reconstruction based on patient-reported outcome measures and health-related quality of life. Ann Surg 2010; 252: 929942.
  • 15
    Lee C, Sunu C, Pignone M. Patient-reported outcomes of breast reconstruction after mastectomy: a systematic review. J Am Coll Surg 2009; 209: 123133.
  • 16
    Sanoff HK, Goldberg RM, Pignone MP. A systematic review of the use of quality of life measures in colorectal cancer research with attention to outcomes in elderly patients. Clin Colorectal Cancer 2007; 6: 700709.
  • 17
    Efficace F, Bottomley A, Vanvoorden V, Blazeby JM. Methodological issues in assessing health-related quality of life of colorectal cancer patients in randomised controlled trials. Eur J Cancer 2004; 40: 187197.
  • 18
    Bartels SA, Vlug MS, Ubbink DT, Bemelman WA. Quality of life after laparoscopic and open colorectal surgery: a systematic review. World J Gastroenterol 2010; 16: 50355041.
  • 19
    Jansen L, Koch L, Brenner H, Arndt V. Quality of life among long-term (≥ 5 years) colorectal cancer survivors—systematic review. Eur J Cancer 2010; 46: 28792888.
  • 20
    Gujral S, Avery KN, Blazeby JM. Quality of life after surgery for colorectal cancer: clinical implications of results from randomised trials. Support Care Cancer 2008; 16: 127132.
  • 21
    Parameswaran R, McNair A, Avery KN, Berrisford RG, Wajed SA, Sprangers MA et al. The role of health-related quality of life outcomes in clinical decision making in surgery for esophageal cancer: a systematic review. Ann Surg Oncol 2008; 15: 23722379.
  • 22
    Scarpa M, Valente S, Alfieri R, Cagol M, Diamantis G, Ancona E et al. Systematic review of health-related quality of life after esophagectomy for esophageal cancer. World J Gastroenterol 2011; 17: 46604674.
  • 23
    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: 377388.
  • 24
    Pachler J, Wille-Jorgensen P. Quality of life after rectal resection for cancer, with or without permanent colostomy. Cochrane Database Syst Rev 2005; (2)CD004323.
  • 25
    Whistance RN, Blazeby JM. Systematic review: quality of life after treatment for upper gastrointestinal cancer. Curr Opin Support Palliat Care 2011; 5: 3746.
  • 26
    Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 2004; 350: 20502059.
  • 27
    Weeks JC, Nelson H, Gelber S, Sargent D, Schroeder G; Clinical Outcomes of Surgical Therapy (COST) Study Group. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. JAMA 2002; 287: 321328.
  • 28
    Mansel RE, Fallowfield L, Kissin M, Goyal A, Newcombe RG, Dixon JM et al. Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: The ALMANAC trial. J Natl Cancer Inst 2006; 98: 599609.
  • 29
    International Breast Cancer Study Group, Rudenstam CM, Zahrieh D, Forbes JF, Crivellari D, Holmberg SB et al. Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: first results of International Breast Cancer Study Group Trial 10-93. J Clin Oncol 2006; 24: 337344.
  • 30
    Newell C. Involving the public in NHS, public health, and social care research: briefing notes for researchers (2nd edition). Health Expect 2005; 8: 9192.
  • 31
    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; 18: 11311136.
  • 32
    Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30: 473483.
  • 33
    Blazeby JM, Conroy T, Hammerlid E, Fayers P, Sezer O, Koller M et al.; European Organisation for Research and Treatement of Cancer Gastrointestinal and Quality of Life Groups. Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer. Eur J Cancer 2003; 39: 13841394.
  • 34
    Smets EMA, Garssen B, Bonke B, Dehaes JCJM. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res 1995; 39: 315325.
  • 35
    Patient-Reported Outcome and Quality of Life Database. http://www.proqolid.org [assessed 15 August 2012].
  • 36
    Blazeby JM, Nicklin J, Barham CP, Falk SJ, Alderson D. Clinical and quality-of-life outcomes during tri-modality treatment for oesophageal cancer. Br J Surg 2002; 89(Suppl 1): 6364.
  • 37
    Homs MYV, Essink-Bot ML, Borsboom GJJM, Steyerberg EW, Siersema PD; Dutch SIREC Study Group. Quality of life after palliative treatment for oesophageal carcinoma—a prospective comparison between stent placement and single dose brachytherapy. Eur J Cancer 2004; 40: 18621871.
  • 38
    Avery K, Blazeby JM. Quality of life assessment in surgical oncology trials. World J Surg 2006; 30: 11631172.
  • 39
    Sprangers MAG, Cull A, Bjordal K, Groenvold M, Aaronson NK. The European Organization for Research and Treatment of Cancer. Approach to quality of life assessment: guidelines for developing questionnaire modules. EORTC Study Group on Quality of Life. Qual Life Res 1993; 2: 287295.
  • 40
    Doward LC, Gnanasakthy A, Baker MG. Patient reported outcomes: looking beyond the label claim. Health Qual Life Outcomes 2010; 8: 89.
  • 41
    Rutten LJF, Arora NK, Bakos AD, Aziz N, Rowland J. Information needs and sources of information among cancer patients: a systematic review of research (1980–2003). Patient Educ Couns 2005; 57: 250261.
  • 42
    Rees JR, Blazeby JM, Fayers P, Friend EA, Welsh FK, John TG et al. Patient-reported outcomes after hepatic resection of colorectal cancer metastases. J Clin Oncol 2012; 30: 13641370.
  • 43
    Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T et al. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med 2001; 345: 638646.
  • 44
    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: 979985.
  • 45
    King MT, Fayers PM. Making quality-of-life results more meaningful for clinicians. Lancet 2008; 371: 709710.
  • 46
    Brundage M, Feldman-Stewart D, Leis A, Bezjak A, Degner L, Velji K et al. Communicating quality of life information to cancer patients: a study of six presentation formats. J Clin Oncol 2005; 23: 69496956.
  • 47
    Mcnair AGK, Brookes ST, Davis CR, Argyropoulos M, Blazeby JM. Communicating the results of randomized clinical trials: do patients understand multidimensional patient-reported outcomes? J Clin Oncol 2010; 28: 738743.
  • 48
    Ahmed H, Naik G, Willoughby H, Edwards AG. Communicating risk. BMJ 2012; 344: e3996.
  • 49
    Davis C, McNair A, Brigic A, Clarke M, Brookes S, Thomas M et al. Optimising methods for communicating survival data to patients undergoing cancer surgery. Eur J Cancer 2010; 46: 31923199.
  • 50
    Department of Health. The NHS Cancer Plan: a Plan for Investment, a Plan for Reform. Department of Health: London, 2000.
  • 51
    Department of Health. Cancer Reform Strategy. Department of Health: London, 2007.
  • 52
    Tripathy D. Multidisciplinary care for breast cancer: barriers and solutions. Breast J 2003; 9: 6063.
  • 53
    Zorbas H, Barraclough B, Rainbird K, Luxford K, Redman S. Multidisciplinary care for women with early breast cancer in the Australian context: what does it mean? Med J Aust 2003; 179: 528531.
  • 54
    Valdagni R, Salvioni R, Nicolai N, Villa S, Bedini N, Bajetta E et al. In regard to Kagan: ‘The multidisciplinary clinic’ (Int J Radiat Oncol Biol Phys 2005; 61: 967–968). Int J Radiat Oncol Biol Phys 2005; 63: 309310.
  • 55
    Kidger J, Murdoch J, Donovan JL, Blazeby JM. Clinical decision-making in a multidisciplinary gynaecological cancer team: a qualitative study. BJOG 2009; 116: 511517.
  • 56
    National Institute for Health and Clinical Excellence. http://www.nice.org.uk [accessed 24 August 2012].
  • 57
    Core Outcomes Measures in Effectiveness Trials. http://www.comet-initiative.org [accessed 24 August 2012].
  • 58
    Blencowe NS, Strong S, McNair AG, Brookes ST, Crosby T, Griffin SM et al. Reporting of short-term clinical outcomes after esophagectomy a systematic review. Ann Surg 2012; 255: 658666.
  • 59
    Potter S, Brigic A, Whiting P, Cawthorn S, Avery K, Donovan J et al. Reporting clinical outcomes of breast reconstruction: a systematic review. J Natl Cancer Inst 2011; 103: 3146.
  • 60
    Potter S, Harcourt D, Cawthorn S, Warr R, Mills N, Havercroft D et al. Assessment of cosmesis after breast reconstruction surgery: a systematic review. Ann Surg Oncol 2011; 18: 813823.
  • 61
    Whistance R, Blencowe N, Blazeby J. The need for standardised outcome reporting in colorectal surgery. Gut 2012; 61: 472.
  • 62
    Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med 2011; 8: e1000393.
  • 63
    Calvert M, Blazeby J, Revicki D, Moher D, Brundage M. Reporting quality of life in clinical trials: a CONSORT extension. Lancet 2011; 378: 16841685.