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Quality of Life Research

Erschienen in:

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

verfasst von: Carol M. Moinpour, Gary W. Donaldson, Yoshio Nakamura

Erschienen in: Quality of Life Research | Ausgabe 2/2009

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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.

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.

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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
verfasst von: Carol M. Moinpour
Gary W. Donaldson
Yoshio Nakamura
Publikationsdatum: 01.03.2009
Verlag: Springer Netherlands
Erschienen in: Quality of Life Research / Ausgabe 2/2009
Print ISSN: 0962-9343
Elektronische ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-008-9433-3

Springer Medizin

Abstract

Purpose

Methods

Results

Conclusions

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