When study site contributes to outcomes in a multi-center randomized trial: a secondary analysis of decisional conflict in men with localized prostate cancer

Health and Quality of Life Outcomes

Donna L Berry¹  Fangxin Hong²  Meghan L Underhill¹ 

[1] The Phyllis F. Cantor Center for Research in Nursing & Patient Care Services, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston 02115, MA, USA;Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute and Harvard School of Public Health, 450 Brookline Ave, CLSB-11017, Boston 02215, Massachusetts, USA

关键词: Decision-making;    Decisional conflict;    Localized prostate cancer;   

Others  :  1164508
DOI  :  10.1186/s12955-014-0159-3

 received in 2014-05-07, accepted in 2014-10-09,  发布年份 2014

【 摘 要 】

Purpose

Evaluate baseline factors that may explain the influence of study site on decisional conflict (DC) in men from the Personal Patient Profile: Prostate (P3P) randomized trial.

Materials and methods

476 cases from 5 P3P sites were included. Participants completed baseline demographic assessments, 4 subscales of the DC scale at baseline (uncertainty, informed, values clarity, and support), the Expanded Prostate Cancer Index Composite (short form) and the State-Trait Anxiety Inventory. Site data regarding typical practices were collected. Linear regressions were used to model the relation between baseline DC scores and study site adjusting for the list of variables.

Results

Baseline decisional uncertainly (p?=?0.001) and informed (p?=?0.03) subscales were significantly different across sites. Participant demographic and baseline measures were significantly different (p?uncertainty and values clarity subscales: a preferred treatment choice at study entry, whether the study program was accessed at home vs. in clinic, number of doctors consulted pre-study, working status, state anxiety, information from the media or a health care provider, and perceived knowledge level. State anxiety was associated with higher DC across all subscales.

Conclusions

Individual characteristics of men seeking consultation for LPC were associated with DC at baseline, not the site alone; anxiety contributed to higher conflict. These findings will inform future development and implementation of the P3P and other decision support interventions.

Trial registration

NCT00692653 webcite.

【 授权许可】

   
2014 Underhill et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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