Impact of response shift on longitudinal quality-of-life assessment in cancer clinical trials

References

• Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J. Clin. Epidemiol.56(5), 395–407 (2003).
   PubMed Web of Science ®Google Scholar
• Ubel PA, Peeters Y, Smith D. Abandoning the language of “response shift”: a plea for conceptual clarity in distinguishing scale recalibration from true changes in quality of life. Qual. Life Res.19(4), 465–471 (2010).
   PubMedGoogle Scholar
• Sprangers MA, Schwartz CE. Integrating response shift into health related quality of life research: a theoretical model. Soc. Sci. Med.48, 1507–1515 (1999).
   PubMed Web of Science ®Google Scholar
• Schwartz CE, Sprangers MA. Methodological approaches for assessing response shift in longitudinal health related quality of life research. Soc. Sci. Med.48, 1531–1548 (1999).
   PubMed Web of Science ®Google Scholar
• Gibbons FX. Social comparison as a mediator of response shift. Soc. Sci. Med.48, 1517–1530 (1999).
   PubMed Web of Science ®Google Scholar
• Wilson IB. Clinical understanding and clinical implications of response shift. Soc. Sci. Med.48, 1577–1588 (1999).
   PubMed Web of Science ®Google Scholar
• Schwartz C, Bode R, Repucci N, Becker J, Sprangers M, Fayers P. The clinical significance of adaptation to changing health: a meta-analysis of response shift. Qual. Life Res.15, 1533–1550 (2006).
   PubMed Web of Science ®Google Scholar
• Osborne RH, Hawkins M, Sprangers MA. Change of perspective: a measurable and desired outcome of chronic disease self-management intervention programs that violates the premise of preintervention/postintervention assessment. Arthritis Rheum.55(3), 458–465 (2006).
   PubMed Web of Science ®Google Scholar
• Constitution of the World Health Organisation. World Health Organisation, Geneva, Switzerland (1946).
   Google Scholar
• Gill TM, Feinstein AR. A critical appraisal of the quality-of-life measurements. JAMA272, 619–626 (1994).
   PubMed Web of Science ®Google Scholar
• Kaplan RM, Bush JW. Health-related quality of life measurement for evaluation research and policy analysis. Health Psychology1, 61–80 (1982).
   Google Scholar
• Testa MA, Simonson DC. Assessment of quality-of-life outcomes. N. Engl. J. Med.334(13), 835–840 (1996).
   PubMed Web of Science ®Google Scholar
• Karnofsky D, Burchenal J. The clinical evaluation of chemotherapeutic agents. In: Evaluation of Chemotherapeutic Agents. Maclead C (Ed.). Columbia University Press, NY, USA, 191–205 (1949).
   Google Scholar
• Johnson JR, Temple R. Food and Drug Administration requirements for approval of new anticancer drugs. Cancer Treat. Rep.69(10), 1155–1159 (1985).
   PubMedGoogle Scholar
• Gotay CC, Moore TD. Assessing quality of life in head and neck cancer. Qual. Life Res.1(1), 5–17 (1992).
   PubMedGoogle Scholar
• Carr AJ, Gibson B, Robinson PG. Is quality of life determined by expectations or experience? BMJ322, 1240–1243 (2001).
   PubMed Web of Science ®Google Scholar
• Allison PJ, Locker D, Feine JS. Quality of life: a dynamic construct. Soc. Sci. Med.45(2), 221–230 (1997).
   PubMed Web of Science ®Google Scholar
• Calman KC. Quality of life in cancer patients – an hypothesis. J. Med. Ethics10(3), 124–127 (1984).
   PubMed Web of Science ®Google Scholar
• Diener E. Subjective well-being. Psychol. Bull.95(3), 542–575 (1984).
   PubMed Web of Science ®Google Scholar
• Englert JS, Ahrens B, Gebhardt R et al. Implications of the concepts “coping” and “quality of life” for criteria of course and outcome. Pharmacopsychiatry27(Suppl. 1), 34–36 (1994).
   PubMedGoogle Scholar
• Howard GS, Ralph KM, Gulanick NA, Maxwell SE, Nance SW, Gerber SK. Internal invalidity in pre-test-posttest self-report evaluations and a re-evaluation of retrospective pre-tests. Appl. Psychol. Meas.3, 1–23 (1979).
   Google Scholar
• Howard GS, Dailey PR, Gulanick NA. The feasibility of informed pre-tests in attenuating response-shift bias. Appl. Psychol. Meas.3, 481–494 (1979).
   Google Scholar
• Howard GS, Millham J, Slaten S, O’Donnell L. Influence of subject response style effects on retrospective measures. Appl. Psychol. Meas.5, 89–100 (1981).
   Web of Science ®Google Scholar
• Howard GS, Schmeck RR, Bray JH. Internal invalidity in studies employing self-report instruments. A suggested remedy. J. Ed. Meas.16, 129–135 (1979).
   Web of Science ®Google Scholar
• Howard GS, Dailey PR. Response shift bias: a source of contamination of self-report measures. Appl. Psychol. Meas.64, 144–150 (1979).
   Google Scholar
• Golembiewski RT, Billingsley K, Yeager S. Measuring change and persistence in human affairs: types of change generated by OLD designs. JAB12, 133–157 (1976).
   Google Scholar
• Barclay-Goddard R, Epstein JD, Mayo NE. Response shift: a brief overview and proposed research priorities. Qual. Life Res.18(3), 335–346 (2009).
   PubMed Web of Science ®Google Scholar
• Rapkin BD, Schwartz CE. Toward a theoretical model of quality-of-life appraisal: implications of findings from studies of response shift. Health Qual. Life Outcomes2, 14 (2004).
   PubMedGoogle Scholar
• Ahmed S, Mayo NE, Wood-Dauphinee S, Hanley JA, Cohen SR. Response shift influenced estimates of change in health-related quality of life poststroke. J. Clin. Epidemiol.57(6), 561–570 (2004).
   PubMed Web of Science ®Google Scholar
• Razmjou H, Yee A, Ford M, Finkelstein JA. Response shift in outcome assessment in patients undergoing total knee arthroplasty. J. Bone Joint Surg. Am.88(12), 2590–2595 (2006).
   PubMed Web of Science ®Google Scholar
• Ring L, Höfer S, Heuston F, Harris D, O’Boyle CA. Response shift masks the treatment impact on patient reported outcomes (PROs): the example of individual quality of life in edentulous patients. Health Qual. Life Outcomes3, 55 (2005).
   PubMedGoogle Scholar
• Bernhard J, Hürny C, Maibach R, Herrmann R, Laffer U. Quality of life as subjective experience: reframing of perception in patients with colon cancer undergoing radical resection with or without adjuvant chemotherapy. Swiss Group for Clinical Cancer Research (SAKK). Ann. Oncol.10(7), 775–782 (1999).
   PubMed Web of Science ®Google Scholar
• Bonnetain F, Bouché O, Michel P et al. A comparative longitudinal quality of life study using the Spitzer quality of life index in a randomized multicenter Phase III trial (FFCD 9102): chemoradiation followed by surgery compared with chemoradiation alone in locally advanced squamous resectable thoracic esophageal cancer. Ann. Oncol.17(5), 827–834 (2006).
   PubMed Web of Science ®Google Scholar
• Sprangers MA. Disregarding clinical trial-based patient-reported outcomes is unwarranted: five advances to substantiate the scientific stringency of quality-of-life measurement. Acta Oncol.49(2), 155–163 (2010).
   PubMed Web of Science ®Google Scholar
• Schwartz CE, Sprangers MA. Guidelines for improving the stringency of response shift research using the thentest. Qual. Life Res.19(4), 455–464 (2010).
   PubMed Web of Science ®Google Scholar
• Nolte S, Elsworth GR, Sinclair AJ, Osborne RH. Tests of measurement invariance failed to support the application of the ‘then-test’. J. Clin. Epidemiol.62(11), 1173–1180 (2009).
   PubMed Web of Science ®Google Scholar
• McPhail S, Haines T. Response shift, recall bias and their effect on measuring change in health-related quality of life amongst older hospital patients. Health Qual. Life Outcomes8, 65 (2010).
   PubMed Web of Science ®Google Scholar
• Visser MR, Smets EM, Sprangers MA, de Haes HJ. How response shift may affect the measurement of change in fatigue. J. Pain Symptom Manage.20, 12–18 (2000).
   PubMed Web of Science ®Google Scholar
• Terborg JR, Maxwell SE, Howard GS. On the measurement and control of β change: problems with the Bedeian, Armenakis, and Gibson technique. Academy of Management7, 292–295 (1982).
   Google Scholar
• Terborg JR, Maxwell SE, Howard GS. Evaluating planned organizational change: a method for assessing α, β and γ change. Academy of Management5, 109–121 (1980).
   Google Scholar
• Schmitt N, Pulakos E, Lieblein A. Comparison of three techniques to assess group-level β and γ change. App. Psychol. Meas.8, 249–260 (1984).
   Web of Science ®Google Scholar
• Powell C. Quality of life measurement. J. Med. Ethics12, 222–223 (1987).
   Google Scholar
• Visser MR, Oort FJ, Sprangers MA. Methods to detect response shift in quality of life data: a convergent validity study. Qual. Life Res.14(3), 629–639 (2005).
   PubMed Web of Science ®Google Scholar
• Bernheim JL, Buyse M. The Anamnestic Comparative Self-Assessment for measuring the subjective quality of life of cancer patients. J. Psychosocial Oncol.1, 25–38 (1983).
   Google Scholar
• Bonnetain F, Conroy T, Velten M et al. Impact of response shift (RS) in longitudinal post-operative quality of life (QoL) analysis among breast cancer (BC) patients: a randomized multicenter cohort study. Presented at: 17th Annual Conference of the International Society for Quality of Life Research. London, UK, 27–30 October 2010.
   Google Scholar
• O’Boyle CA, McGee H, Hickey A, O’Malley K, Joyce CR. Individual quality of life in patients undergoing hip replacement. Lancet339(8801), 1088–1091 (1992).
   PubMed Web of Science ®Google Scholar
• Hickey AM, Bury G, O’Boyle CA, Bradley F, O’Kelly FD, Shannon W. A new short form individual quality of life measure (SEIQoL-DW): application in a cohort of individuals with HIV/AIDS. BMJ313(7048), 29–33 (1996).
   PubMed Web of Science ®Google Scholar
• Korfage IJ, de Koning HJ, Essink-Bot ML. Response shift due to diagnosis and primary treatment of localized prostate cancer: a then-test and a vignette study. Qual. Life Res.10, 1627–1634 (2007).
   Google Scholar
• Ahmed S, Mayo NE, Wood-Dauphinee S, Hanley JA, Cohen SR. The structural equation modeling technique did not show a response shift, contrary to the results of the then test and the individualized approaches. J. Clin. Epidemiol.58(11), 1125–1133 (2005).
   PubMed Web of Science ®Google Scholar
• Schmitt N. The use of analysis of covariance structures to assess β and γ change. Multivariate Behavioural Research17, 343–358 (1982).
   PubMed Web of Science ®Google Scholar
• Oort FJ. Using structural equation modeling to detect response shifts and true change. Qual. Life Res.14(3), 587–598 (2005).
   PubMed Web of Science ®Google Scholar
• Andrykowski MA, Donovan KA, Jacobsen PB. Magnitude and correlates of response shift in fatigue ratings in women undergoing adjuvant therapy for breast cancer. J. Pain Symptom Manage.37, 341–351 (2009).
   PubMed Web of Science ®Google Scholar
• Sprangers MAG, van Dam FSAM, Broersen J et al. Revealing response shift in longitudinal research on fatigue: the use of the then-test approach. Acta Oncol.38, 709–718 (1999).
   PubMed Web of Science ®Google Scholar
• Schwartz CE, Feinberg RG, Jilinskaia E, Applegate JC. An evaluation of a psychosocial intervention for survivors of childhood cancer: paradoxical effects of response shift over time. Psycho-Oncology8, 344–354 (1999).
   PubMed Web of Science ®Google Scholar
• Oort FJ, Visser MR, Sprangers MA. An application of structural equation modeling to detect response shifts and true change in quality of life data from cancer patients undergoing invasive surgery. Qual. Life Res.14(3), 599–609 (2005).
   PubMed Web of Science ®Google Scholar
• Hagedoorn M, Sneeuw KC, Aaronson NK. Changes in physical functioning and quality of life in patients with cancer: response shift and relative evaluation of one’s condition. J. Clin. Epidemiol.55, 176–183 (2002).
   PubMed Web of Science ®Google Scholar
• Bernhard J, Lowy A, Maibach R, Hürny C; Swiss Group for Clinical Cancer Research (SAKK) and the Swiss Institute for Applied Cancer Research (SIAK). Response shift in the perception of health for utility evaluation. An explorative investigation. Eur. J. Cancer37(14), 1729–1735 (2001).
   PubMedGoogle Scholar
• Kvam AK, Wisløff F, Fayers PM. Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma. Health Qual. Life Outcomes3(8), 79 (2010).
   Google Scholar
• Reeve BB. An opportunity to refine our understanding of “response shift” and to educate researchers on designing quality research studies: response to Ubel, Peeters, and Smith. Qual. Life Res.19(4), 473–475 (2010).
   PubMedGoogle Scholar
• Eisenhauer EA, Therasse P, Bogaerts J et al.New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur. J. Cancer45(2), 228–247 (2009).
   PubMed Web of Science ®Google Scholar
• Bonnetain F, Dahan L, Maillard E et al. Time until definitive quality of life score deterioration as a means of longitudinal analysis for treatment trials in patients with metastatic pancreatic adenocarcinoma. Eur. J. Cancer46(15), 2753–2762 (2010).
   PubMed Web of Science ®Google Scholar
• Hamidou Z, Dabakuyo TS, Mercier M et al. Time to deterioration in quality of life score as a modality of longitudinal analysis in patients with breast cancer. Presented at: 17th Annual Conference of the International Society for Quality of Life Research. London, UK, 27–30 October 2010.
   Google Scholar