Surgery
Volume 145, Issue 6 , Pages 622-626 , June 2009

The importance of determining quality of life in clinical trials

  • Larissa Temple, MD

      Affiliations

    • Corresponding Author InformationReprint requests: Larissa Temple, MD, Colorectal Service, Department of surgery, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, Room C-1079, New York, NY 10065.
  • ,
  • Sarah Fuzesi, BA
  • ,
  • Sujata Patil, PhD

,Accepted 1 November 2008.

References 

  1. Efficace F, Kemmler G, Vignetti M, Mandelli F, Molica S, Holzner B. Health-related quality of life assessment and reported outcomes in leukaemia randomised controlled trials—a systematic review to evaluate the added value in supporting clinical decision making. Eur J Cancer. 2008;44:1497–1506
  2. Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, et al. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004;22:714–724
  3. World Health Organization. Constitution of the World Health Organization. Geneva: WHO, 1948 [cited 2008 Mar 15]. Available from: http://www.searo.who.int/LinkFiles/About_SEARO_const.pdf.
  4. Gotay CC, Korn EL, McCabe MS, Moore TD, Cheson BD. Quality-of-life assessment in cancer treatment protocols: research issues in protocol development. J Natl Cancer Inst. 1992;84:575–579
  5. Camilleri-Brennan J, Steele RJ. Quality of life after treatment for rectal cancer. Br J Surg. 1998;85:1036–1043
  6. Olschewski M, Schulgen G, Schumacher M, Altman DG. Quality of life assessment in clinical cancer research. Br J Cancer. 1994;70:1–5
  7. Aday LA. Designing and conducting health surveys. 2nd ed.. San Francisco: Jossey-Bass; 1996;
  8. Vickers AJ. Statistical considerations for use of composite health-related quality-of-life scores in randomized trials. Qual Life Res. 2004;13:717–723
  9. Neuman HB, Schrag D, Cabral C, Weiser MR, Paty PB, Guillem JG, et al. Can differences in bowel function after surgery for rectal cancer be identified by the European Organization for Research and Treatment of Cancer quality of life instrument?. Ann Surg Oncol. 2007;14:1727–1734
  10. Temple LK, Bacik J, Savatta SG, Gottesman L, Paty PB, Weiser MR, et al. The development of a validated instrument to evaluate bowel function after sphincter-preserving surgery for rectal cancer. Dis Colon Rectum. 2005;48:1353–1365
  11. Whalen GF, Ferrans CE. Quality of life as an outcome in clinical trials and cancer care: a primer for surgeons. J Surg Onc. 2001;77:270–276
  12. Sprangers MAG, Moinpour CM, Moynihan TJ, Patrick DL, Revicki DA. and the Clinical Significance Consensus Meeting Group. Assessing meaningful change in quality of life over time: a users' guide for clinicians. Mayo Clin Proc. 2002;77:561–571
  13. Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998;16:139–144
  14. Dueck A, Novotny PJ, Sloan JA. Dealing with multiple endpoints. Curr Probl Cancer. 2006;30:298–306
  15. Salant P, Dillman DA. How to conduct your own survey. New York: John Wiley & Sons; 1994;
  16. Oh HL, Scheuren F. Weighting adjustments for unit nonresponse. In:  Madow WG,  Olkin I,  Rubin DB editor. Incomplete data in sample surveys, vol. 2: Theory and bibliographies. New York/London: Academic Press; 1983;p. 143–184
  17. Kalton G. Compensating for missing survey data. Ann Arbor: University of Michigan Institute for Social Research Survey Research Center; 1983;
  18. Little RJA. Survey nonresponse adjustments for estimates of means. Int Stat Rev. 1986;54:137–139

PII: S0039-6060(09)00111-1

doi: 10.1016/j.surg.2008.11.012

Surgery
Volume 145, Issue 6 , Pages 622-626 , June 2009