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Quality of Life Research

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01-03-2009

Chemotherapeutic impact on pain and global health-related quality of life in hormone-refractory prostate cancer: Dynamically Modified Outcomes (DYNAMO) analysis of a randomized controlled trial

Auteurs: Carol M. Moinpour, Gary W. Donaldson, Yoshio Nakamura

Gepubliceerd in: Quality of Life Research | Uitgave 2/2009

Abstract

Purpose

This paper applies the Dynamically Modified Outcomes (DYNAMO) model to a clinical trial of two chemotherapeutic regimens on global health-related quality of life (GHRQL) in hormone-refractory prostate cancer.

Methods

DYNAMO identifies the causal influences operating in a clinical trial and their mediation, moderation, and modulation by uncontrolled variables. The Southwest Oncology Group trial S9916 randomized assignment to mitoxantrone plus prednisone (M + P) versus docetaxel plus estramustine (D + E) treatments. In this application, we examine baseline-adjusted impacts of worst pain (McGill Pain Questionnaire) on GHRQL (EORTC Quality of Life Questionnaire-C30) at 10 weeks.

Results

The average treatment levels of pain did not differ, hence, the average mediated effect of treatment on GHRQL was zero. Nonetheless, M + P reduced the impact (the relational outcome) of pain on GHRQL by 54% relative to D + E. Individual variation in the relational outcome (modulation) was of the same magnitude as the average difference between the groups. Performance status moderated the direct effects of treatment, with D + E being more effective in good, but not poor, performance strata.

Conclusions

The DYNAMO approach comprehensively accounted for treatment effects. Rather than a single average effect, there were three distinct treatment effects: one direct effect for each performance status level and a direct effect on the relationship between pain and GHRQL.

vorige artikel Mediators, moderators, and modulators of causal effects in clinical trials––Dynamically Modified Outcomes (DYNAMO) in health-related quality of life

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These standard adjustments have no effect on the interpretation of the key features of the model, but merely condition responses on baseline values.

In this and all statements drawn from Figs. 3 and 4, the conclusions about therapeutic impact pertain to receiving one therapy instead of the other. The attributed causal impacts are relative, not absolute.

Donaldson, G. W. (2003). General linear contrasts on latent variable means: Structural equation hypothesis tests for multivariate clinical trials. Statistics in Medicine, 22, 2893–2917. doi:10.1002/sim.1558.PubMedCrossRef

Donaldson, G. W., & Moinpour, C. M. (2002). Individual differences in quality-of-life treatment response. Medical Care, 40(6 Suppl), III39–III53. doi:10.1097/00005650-200206001-00007.PubMed

Moinpour, C. M., Donaldson, G. W., & Redman, M. W. (2007). Do general dimensions of quality of life add clinical value to symptom data? Journal of the National Cancer Institute. Monographs, 37, 31–38. doi:10.1093/jncimonographs/lgm007.PubMedCrossRef

Petrylak, D. P., Tangen, C. M., Hussein, M. H. A., Lara, P. N., Jr., Jones, J. A., Taplin, M. E., et al. (2004). Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. The New England Journal of Medicine, 351(15), 1513–1520. doi:10.1056/NEJMoa041318.PubMedCrossRef

Berry, D. L., Moinpour, C. M., Jiang, C. S., Ankerst, D. P., Petrylak, D. P., Vinson, L. V., et al. (2006). Quality of life and pain in advanced stage prostate cancer: Results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone. Journal of Clinical Oncology, 24(18), 2828–2835. doi:10.1200/JCO.2005.04.8207.PubMedCrossRef

Laird, N. M., & Ware, J. H. (1982). Random-effects models for longitudinal data. Biometrics, 38, 963–974.PubMedCrossRef

Curran, P. J., & Hussong, A. M. (2003). The use of latent trajectory models in psychopathology research. Journal of Abnormal Psychology, 112(4), 526–544. doi:10.1037/0021-843X.112.4.526.PubMedCrossRef

Singer, J. D., & Willett, J. B. (2003). Applied longitudinal data analysis: Modeling changes and event occurrence. New York: Oxford University Press.

Kline, R. B. (2005). Principles and practice of structural equation modeling. New York: Guilford Press.

10.

Sinibaldi, V. J., Carducci, M. A., Moore-Cooper, S., Laufer, M., Zahurak, M., & Eisenberger, M. A. (2002). Phase II evaluation of docetaxel plus one-day oral estramustine phosphate in the treatment of patients with androgen independent prostate carcinoma. Cancer, 94(5), 1457–1465. doi:10.1002/cncr.10350.PubMedCrossRef

11.

Tannock, I. F., Osoba, D., Stockler, M. R., Ernst, D. S., Neville, A. J., Moore, M. J., et al. (1996). Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: A Canadian randomized trial with palliative end points. Journal of Clinical Oncology, 14(6), 1756–1764.PubMed

12.

Melzack, R. (1987). The short-form McGill pain questionnaire. Pain, 30, 191–197. doi:10.1016/0304-3959(87)91074-8.PubMedCrossRef

13.

Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., et al. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376. doi:10.1093/jnci/85.5.365.PubMedCrossRef

14.

Fayers, P. M., Aaronson, N. K., Bjordal, K., Groenvold, M., Curran, D., Bottomley, A., et al. (2001). EORTC QLQ-C30 scoring manual. Brussels: EORTC.

15.

Borghede, G., & Sullivan, M. (1996). Measurement of quality of life in localized prostatic cancer patients treated with radiotherapy. Development of a prostate cancer-specific module supplementing the EORTC QLQ-C30. Quality of Life Research, 5, 212–222. doi:10.1007/BF00434743.PubMedCrossRef

16.

Muthén, L. K., & Muthén, B. (1998–2005). Mplus user’s guide. Los Angeles: Muthén & Muthén.

17.

Pearl, J. (2000). Causality: Models, reasoning, and inference. Cambridge: Cambridge University Press.

18.

Baron, R. M., & Kenny, D. A. (1986). The moderator–mediator variable distinction in social psychological research: Conceptual, strategic, and statistical considerations. Journal of Personality and Social Psychology, 51, 1173–1182. doi:10.1037/0022-3514.51.6.1173.PubMedCrossRef

19.

Judd, C. M., & Kenny, D. A. (1981). Process analysis: Estimating mediation in treatment evaluations. Evaluation Review, 9, 602–618. doi:10.1177/0193841X8100500502.CrossRef

20.

MacKinnon, D. P., Fairchild, A. J., & Fritz, M. S. (2007). Mediation analysis. Annual Review of Psychology, 58, 593–614. doi:10.1146/annurev.psych.58.110405.085542.PubMedCrossRef

21.

Albert, J. M. (2008). Mediation analysis via potential outcomes models. Statistics in Medicine, 27(8), 1282–1304. doi:10.1002/sim.3016.PubMedCrossRef

22.

Kraemer, H. C., Wilson, G. T., Fairburn, C. G., & Agras, W. S. (2002). Mediators and moderators of treatment effects in randomized clinical trials. Archives of General Psychiatry, 59(10), 877–883. doi:10.1001/archpsyc.59.10.877.PubMedCrossRef

23.

Kraemer, H. C., Lowe, K. K., & Kupfer, D. J. (2005). To your health: How to understand what research tells us about risk. New York: Oxford University Press.

24.

Kraemer, H. C., Stice, E., Kazdin, A., Offord, D., & Kupfer, D. (2001). How do risk factors work together? Mediators, moderators, and independent, overlapping, and proxy risk factors. The American Journal of Psychiatry, 158(6), 848–856. doi:10.1176/appi.ajp.158.6.848.PubMedCrossRef

25.

Edwards, D. (1995). Introduction to graphical modeling. New York: Springer-Verlag.

26.

Edwards, D. (1995). MIM release 3.2. Boston: Free Software Foundation.

Titel: Chemotherapeutic impact on pain and global health-related quality of life in hormone-refractory prostate cancer: Dynamically Modified Outcomes (DYNAMO) analysis of a randomized controlled trial
Auteurs: Carol M. Moinpour
Gary W. Donaldson
Yoshio Nakamura
Publicatiedatum: 01-03-2009
Uitgeverij: Springer Netherlands
Gepubliceerd in: Quality of Life Research / Uitgave 2/2009
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-008-9433-3

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Abstract

Purpose

Methods

Results

Conclusions

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