Skip to main content
Log in

Quality of Life Assessment in Surgical Oncology Trials

  • Published:
World Journal of Surgery Aims and scope Submit manuscript

Abstract

Integrating health-related quality of life (HRQOL) as an endpoint for randomized surgical trials provides valuable insight into the patients’ perspective on treatment outcome. Health related quality of life data also play a role in ensuring fully informed consent, determining treatment options and informing treatment decision making. However, few randomized surgical trials have been conducted that meet the minimum requirements for rigorous HRQL assessment and, despite increasing efforts to improve the reporting of randomized trials, many are still not adequately performed. Such methodologic limitations may influence trial findings for HRQL outcomes and undermine the ability of the data collected to inform clinical practice. This review describes key methodological aspects of HRQL assessment that are required in randomized trials to ensure that data are robust. This includes choice of HRQL instrument, the method and timing of assessments and data analysis and presentation. The review also makes recommendations for future research in this area.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. JAMA 2001;285:1987–1991

    Article  PubMed  CAS  Google Scholar 

  2. Russell I. Evaluating new surgical procedures. Br Med J 1995;311:1243–1244

    CAS  Google Scholar 

  3. Donovan J, Mills N, Smith M, et al. Quality improvement report: improving design and conduct of randomized trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ 2002;325:766–770

    Article  PubMed  Google Scholar 

  4. Roberts C, Sibbald B. Understanding controlled trials. Randomising groups of patients. Br Med J 1998;316:1898–1900

    CAS  Google Scholar 

  5. The American Society of Clinical Oncology. Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol 1996;14:671–679

    Google Scholar 

  6. Hofmann B, Haheim LL, Soreide JA. Ethics of palliative surgery in patients with cancer. Br J Surg 2005;92:802–809

    Article  PubMed  CAS  Google Scholar 

  7. Efficace F, Bottomley A, Osoba D, et al. 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

    Article  PubMed  Google Scholar 

  8. Goodwin PJ, Black JT, Bordeleau LJ, et al. Health-related quality-of-life measurement in randomized clinical trials in breast cancer—taking stock. J Natl Cancer Inst 2003;95:263

    Article  PubMed  Google Scholar 

  9. Efficace F, Bottomley A, Vanvoorden V, et al. Methodological issues in assessing health-related quality of life of colorectal cancer patients in randomized controlled trials. Eur J Cancer 2004;40:187–197

    Article  PubMed  CAS  Google Scholar 

  10. Bottomley A, Efficace F, Thomas R, et al. Health-related quality of life in non-small-cell lung cancer: methodologic issues in randomized controlled trials. J Clin Oncol 2003;21:2982–2992

    Article  PubMed  Google Scholar 

  11. de Haes JC, Welvaart K. Quality of life after breast cancer surgery. J Surg Oncol 1985;28:123–125

    PubMed  Google Scholar 

  12. De Haes JCJM, Van Oostrom MA, Welvaart K. The effect of radical and conserving surgery on the quality of life of early breast cancer patients. Eur J Surg Oncol 1986;12:337–342

    PubMed  Google Scholar 

  13. Kemeny MM, Wellisch DK, Schain WS. Psychosocial outcome in a randomized surgical trial for treatment of primary breast cancer. Cancer 1988;62:1231–1237

    Article  PubMed  CAS  Google Scholar 

  14. Levy SM, Herberman RB, Lee JK, et al. Breast conservation versus mastectomy: distress sequelae as a function of choice. J Clin Oncol 1989;7:367–375

    PubMed  CAS  Google Scholar 

  15. Poulson B, Graversen HP, Beckmann J, et al. A comparative study of post-operative psychosocial function in women with primary operable breast cancer randomized to breast conservation therapy or mastectomy. Eur J Surg Oncol 1997;23:327–334

    Article  Google Scholar 

  16. Curran D, van Dongen JP, Aaronson NK, et al. Quality of life of early-stage breast cancer patients treated with radical mastectomy or breast-conserving procedures: results of EORTC Trial 10801. The European Organization for Research and Treatment of Cancer (EORTC), Breast Cancer Co-operative Group (BCCG). Eur J Cancer 1998;34:307–314

    Article  PubMed  CAS  Google Scholar 

  17. Fossa SD, Curran D, Aaronson NK, et al. Quality of life of patients with newly diagnosed poor prognosis M1 prostate cancer undergoing orchiectomy without or with mitomycin C. Results from the EORTC Phase-III trial 30893. Eur Urol 2000;37:541–551

    Article  PubMed  CAS  Google Scholar 

  18. Akakura K, Isaka S, Akimoto S, et al. Long-term results of a randomized trial for the treatment of stages B2 and C prostate cancer: radical prostatectomy versus external beam radiation therapy with a common endocrine therapy in both modalities. Urology 1999;54:313–318

    Article  PubMed  CAS  Google Scholar 

  19. Tyrrell CJ, Kaisary AV, Iversen P, et al. A randomized comparison of ‘Casodex’ (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol 1998;33:447–456

    Article  PubMed  CAS  Google Scholar 

  20. Steineck G, Helgesen F, Adolfsson J, et al. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med 2002;347:790–796

    Article  PubMed  Google Scholar 

  21. Avery KNL, Metcalfe C, Nicklin J, et al. Satisfaction with care: an independent outcome measure in surgical oncology. Ann Surg Oncology. 2006;13:817–822

    Article  Google Scholar 

  22. Sanders C, Egger M, Donovan JL, et al. Reporting on quality of life in randomized controlled trials: bibliographic study. Br Med J 1998;317:1191–1194

    CAS  Google Scholar 

  23. Lee CW, Chi KN. The standard of reporting of health-related quality of life in clinical cancer trials. J Clin Epidemiol 2000;53:451–458

    Article  PubMed  CAS  Google Scholar 

  24. Fitzpatrick R, Davey C, Buxton M, et al. Executive summary: evaluating patient-based outcome measures for use in clinical trials. Health Technology Assessment NHS R&D HTA Progamme 14, 1998

  25. Cella D. FACIT Manual, Vol. 4, Chicago, IL, Evanston Northwestern Healthcare, 1997

    Google Scholar 

  26. Aaronson NK, Ahmedzai S, Bergman B, 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;85:365–376

    PubMed  CAS  Google Scholar 

  27. Fallowfield LJ. Quality of quality of life data. The Lancet 1996;348:421

    Article  CAS  Google Scholar 

  28. Blazeby JM, Williams MH, Alderson D, et al. Observer variation in assessment of quality of life in patients with oesophageal cancer. Br J Surg 1995;82:1200–1203

    PubMed  CAS  Google Scholar 

  29. Hjermstad MJ, Fayers PM, Bjordal K, et al. Using reference data on quality of life—the importance of adjusting for age and gender, exemplified by the EORTC QLQ-C30 (+3). Eur J Cancer 1998;34:1381–1389

    Article  PubMed  CAS  Google Scholar 

  30. Patrick D, Martin M, Bushnell D, et al. Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL). Urology 1999;53:71–76

    Article  PubMed  CAS  Google Scholar 

  31. Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol 1993;46:1417–1432

    Article  PubMed  CAS  Google Scholar 

  32. Kirkwood BR, Sterne JAC. Essential Medical Statistics, 2nd Ed, Oxford, Blackwell Science, 2003;351–354

    Google Scholar 

  33. Fayers PM, Machin D. Quality of Life: Assessment, Analysis and Interpretation, 1st Ed, Chichester, New York, Weinheim, Brisbane, Singapore, Toronto, John Wiley & Sons Ltd, 2000

    Google Scholar 

  34. Machin D, Fayers PM. Sample sizes for randomized trials measuring quality of life. In Staquet MJ, Hays RD, Fayers PM, editors, Quality of Life Assessment in Clinical Trials. Methods and Practice, 1st Ed, Oxford, Oxford University Press, 1998;37–50

    Google Scholar 

  35. De Haes JCJM, Curran D, Young T, et al. Quality of life evaluation in oncological clinical trials-the EORTC model. Eur J Cancer 2000;36:821–825

    Article  PubMed  Google Scholar 

  36. Efficace F, Therasse P, Piccart MJ, et al. Health-related quality of life parameters as prognostic factors in a nonmetastatic breast cancer population: an international multicenter study. J Clin Oncol 2004;22:3381–3388

    Article  PubMed  Google Scholar 

  37. Blazeby JM, Brookes ST, Alderson D. The prognostic value of quality of life scores during treatment for oesophageal cancer. Gut 2001;49:227–230

    Article  PubMed  CAS  Google Scholar 

  38. Young T, de Haes D, Curran P, et al. Guidelines for Assessing Quality of Life in EORTC Clinical Trials. The EORTC Quality of Life Group & EORTC Quality of Life Unit, version 2.0. Brussels, EORTC Publications, 2002

  39. Fayers P, Hays R, editors. Assessing Quality of Life in Clinical Trials: Methods and Practice, 2nd edn. New York, Oxford University Press, 2005

    Google Scholar 

  40. Blazeby JM, Nicklin J, Brookes ST, et al. The feasibility of quality of life assessment in patients with upper gastrointestinal tract cancer. Br J Cancer 2003;89:497–501

    Article  PubMed  CAS  Google Scholar 

  41. Curran D, Molenberghs G, Fayers PM, et al. Incomplete quality of life data in randomized trials: missing forms. Stat Med 1998;17:697–709

    Article  PubMed  CAS  Google Scholar 

  42. Donaldson GW, Moinpour CM. Learning to live with missing quality-of-life data in advanced-stage disease trials. J Clin Oncol 2005;23:7380–7384

    Article  PubMed  Google Scholar 

  43. Revicki D, Fairclough D. Preventing missing data. In Fayers P, Hays R, editors, Assessing Quality of Life in Clinical Trials: Methodsand Practice, 2nd edn. New York, Oxford University Press, 2005;167–178

    Google Scholar 

  44. Fairclough D. Analysing studies with missing data. In Fayers P, Hays R, editors, Assessing Quality of Life in Clinical Trials: Methodsand Practice, 2nd edn. New York, Oxford University Press, 2005;179–194

    Google Scholar 

  45. de Boer AGEM, van Lanschot JJB, van Sandick JW, et al. Quality of life after transhiatal compared with extended transthoracic resection for adenocarcinoma of the esophagus. J Clin Oncol 2004;22:4202–4208

    Article  PubMed  Google Scholar 

  46. Hallbook O, Hass U, Wanstrom A, et al. Quality of life measurement after rectal excision for cancer. Comparison between straight and colonic J-pouch anastomosis. Scand J Gastroenterol 1997;32:490–493

    Article  PubMed  CAS  Google Scholar 

  47. Svedlund J, Sullivan M, Liedman B, et al. Quality of life after gastrectomy for gastric carcinoma: a controlled study of reconstructive procedures. World J Surg 1997;21:422–433

    Article  PubMed  CAS  Google Scholar 

  48. Svedlund J, Sullivan M, Liedman B, et al. Long term consequences of gastrectomy for patient’s quality of life: the impact of reconstructive techniques. Am J Gastroenterol 1999;94:438–445

    Article  PubMed  CAS  Google Scholar 

  49. Brandberg Y, Malm M, Blomqvist L. A prospective and randomized study, “SVEA,” comparing effects of three methods for delayed breast reconstruction on quality of life, patient-defined problem areas of life, and cosmetic result. Plast Reconstr Surg 2000;105:66–74

    PubMed  CAS  Google Scholar 

  50. Furst A, Burghofer K, Hutzel L, et al. Neorectal reservoir is not the functional principle of the colonic J- pouch: the volume of a short colonic J-pouch does not differ from a straight coloanal anastomosis. Dis Colon Rectum 2002;45:660–667

    Article  PubMed  Google Scholar 

  51. Hoksch B, Ablassmaier B, Zieren J, et al. Quality of life after gastrectomy: Longmire’s reconstruction alone compared with additional pouch reconstruction. World J Surg 2002;26:335–341

    Article  PubMed  Google Scholar 

  52. Sailer M, Fuchs KH, Fein M, et al. Randomized clinical trial comparing quality of life after straight and pouch coloanal reconstruction. Br J Surg 2002;89:1108–1117

    Article  PubMed  CAS  Google Scholar 

  53. Weeks JC, Nelson H, Gelber S, et al. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. JAMA 2002;287:321–328

    Article  PubMed  Google Scholar 

  54. Newton-Bishop JA, Nolan C, Turner F, et al. A quality-of-life study in high-risk (thickness ≥ or 2 mm) cutaneous melanoma patients in a randomized trial of 1-cm versus 3-cm surgical excision margins. J Invest Dermatol Symp Proc 2004;9:152–159

    Article  Google Scholar 

  55. Seiler CA, Wagner M, Bachmann T, et al. Randomized clinical trial of pylorus-preserving duodenopancreatectomy versus classical Whipple resection-long term results. Br J Surg 2005;92:547–556

    Article  PubMed  CAS  Google Scholar 

  56. Blazeby J, Avery K, Sprangers M, et al. Role of health-related quality of life in randomised trials in surgical oncology. J Clin Oncol. In press 2006

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Jane M. Blazeby MSc, MD.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Avery, K., Blazeby, J.M. Quality of Life Assessment in Surgical Oncology Trials. World J. Surg. 30, 1163–1172 (2006). https://doi.org/10.1007/s00268-006-0075-8

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00268-006-0075-8

Keywords

Navigation