Medical Decision MakingDecision preparation, satisfaction and regret in a multi-center sample of men with newly diagnosed localized prostate cancer☆
Introduction
Men with localized prostate cancer (LPC) face a treatment decision for which there are multiple options with varying side effect profiles, yet no demonstrable survival advantage for the majority of men diagnosed as low-risk. Despite a myriad of lay and professional patient education sources, direct clinician facilitation of such a treatment decision can be truncated or compromised due to shortened face-to-face clinic visits and the complexity of medical factors intertwined with patients’ personal factors. Moreover, standard counseling, as studies across medical settings have shown [1], may focus more on information giving than elaboration and consideration of patient preferences and expectations.
At a 2011 National Cancer Institute, state-of-the-science conference addressing active surveillance for LPC, experts recommended research in “methods to support shared decision making, including participation of non-physician health care providers and the use of decision support tools” as well as “methods to improve patient satisfaction and reduce regret.” [2, p. 7]. The authors of a 2009 Cochrane review [3] concluded that health care decision aids generally were effective with regard to patients’ involvement in the decision and promoting informed, values-based decisions. In the Ottawa Decision Support Framework (ODSF) [4], [5] the goal of a decision support intervention is to prepare patients for decisions where there is uncertainty about the best approach, outcomes are unpredictable, and individual values, expectations and preferences are relevant. A high quality decision in this framework is one in which the patient has been informed, personal preferences and values honored and the patient is satisfied with the process. Common outcomes in trials of decision support interventions for LPC include the actual choice made, knowledge, decisional conflict, satisfaction with decision making, decisional regret and anxiety [6], [7]. Quality of life outcomes relevant to symptoms and side effects of LPC and its treatment are known to affect satisfaction and may have important relationships with other outcomes [8].
The Personal Patient Profile-Prostate (P3P) intervention [9] was developed to provide tailored decision support to men recently diagnosed with LPC, addressing the complex scenario of medical and personal factors that influence a treatment decision. The Web-based P3P has been shown to significantly decrease decisional conflict over six months, measured at baseline, one and six months, in a multi-center randomized trial [10]. We now report additional outcomes of the P3P trial measured only at one or six months: preparation for decision making, satisfaction with decision, and decision regret. We hypothesized that use of the P3P decision support system would be associated with perceived preparation for decision making, satisfaction with the decision, and lower decisional regret.
Section snippets
Methods
A prospective, randomized clinical trial enrolled 494 of 724 (68%) eligible patients with recent diagnoses of LPC, pre-treatment, to test a decision support system for treatment decision making [10]. Eligible men had T1 or T2, histologically proven LPC, spoke English or Spanish, were consulting with specialists who identified participants as candidates for at least two treatment options, and had not begun therapy. Participants were enrolled at six clinical sites in four American cities, with
Results
At 1 month, 450 of 494 (91.1%) men returned questionnaires or submitted responses on line. Of these, 393 participants reported a treatment preference and/or decision. At 6 months, 436 (88.3%) responded, with 401 having expressed a treatment preference and/or decision. Table 1 displays the demographic characteristics of the sample for each time point. No significant differences in baseline characteristic were found between the participants included in the analyses for 1 month and 6 months and
Discussion
While use of the P3P decision support intervention, in addition to usual preparatory conditions, did not predict significantly higher perceived preparation for decision making or satisfaction and did not significantly lower decisional regret, our findings reveal important associations among these outcomes, interesting baseline characteristics and several mutable variables that can be tested in future trials for enhancing the quality of a LPC treatment decision.
Men who perceived higher
Funding source
This work was funded by National Institutes of Health, National Institute of Nursing Research, R01NR009692.
This material is the result of work supported with resources and use of facilities at the Charlie Norwood VA Medical Center, Augusta, GA, VA Puget Sound Healthcare System, Seattle, WA, and the South Texas Veterans Health Care System, San Antonio, TX.
Conflict of interest
There are no financial disclosures from any authors.
Acknowledgements
The authors acknowledge the contributions of the study participants and skilled research and administrative staff.
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2021, Urologic Oncology: Seminars and Original InvestigationsCitation Excerpt :Clinicians and researchers have been interested in documenting and addressing decision regret that men may experience once a management option is completed or ongoing, as with active surveillance. Registry [5–7] and retrospective survey [8,9] studies, as well as prospective, longitudinal [10,11] and randomized trials [12,13] all conducted between 2008 and 2018 yielded mainly consistent results. Younger age at diagnosis and post-management symptoms were associated with higher regret.
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RCT registration: NCT00692653.