The impact of explicit values clarification exercises in a patient decision aid emerges after the decision is actually made: evidence from a randomized controlled trial.

PURPOSE: To determine if particular values clarification exercises included in a patient decision aid had discernible impact on postdecisional regret in patients with early-stage prostate cancer. METHODS: A multicenter randomized controlled trial compared 2 versions of a computerized patient decision aid: only structured information compared to the structured information plus values clarification exercises. Assessments were conducted during the decision aid visit; telephone follow-up interviews were conducted when patients made their decisions with their physician, 3 months after completing treatment, and >1 year later (per a mailing). Outcome measures included the Decisional Conflict Scale, the Preparation for Decision Making Scale, and the Decision Regret Scale. RESULTS: A total of 156 patients participated, 75 provided information only and 81 provided information plus values clarification exercises. The groups did not differ significantly on any outcome evaluated at the decision aid visit; in both groups, decisional conflict decreased immediately after using the decision aid. Between-group differences emerged after the decision was actually made. The values clarification exercises group reported higher Preparation for Decision Making Scale scores at the decision follow-up and at the >1-year follow-up. Regret did not differ significantly between groups at the 3-month follow-up but was lower for the values clarification exercises group than for the information group at the >1-year follow-up. CONCLUSION: The results suggest that the values clarification exercises led to better preparation for decision making and to less regret. The impact, however, only emerged after the decision was made.

A randomized controlled trial comparing two educational booklets on prostate cancer.

PURPOSE: To compare the helpfulness of two educational aids or booklets on early-stage prostate cancer. METHOD: Participating consecutive patients and a family member, in three centres, received one of two booklets, one produced by AstraZeneca (AZ), the other produced by us (CCE); the patient and family shared a booklet but were separate study participants. The primary outcome was the Purpose-based Information Assessment completed after participants read their booklet; they rated the importance (4-point Likert scale) of six potential purposes for the information: to help organize their thoughts, understand their situations, decide on treatment, plan, provide emotional support to others, and discuss issues. Each participant then rated how helpful their booklet was (4-point Likert scale) in addressing each purpose they had rated above the lowest importance category. Participants mailed in their responses. RESULTS: Complete data were received from 308 (81%) of those who consented to the study: 152 in the CCE group and 156 in the AZ group. The CCE booklet was read for a longer time [chi(2) = 28.61, p = 0.00] but was easier to find information in chi(2) = 7.6, p = 0.05]. Although for each purpose, most readers rated each booklet in one of the top two (of four) helpfulness categories, the CCE booklet was rated more helpful for: organizing [chi(2) = 30.49, p = 0.00], understanding [chi(2) = 12.07, p = .007], deciding [chi(2) = 9.96, p = 0.02] and planning [chi(2) = 18.67, p = 0.00]. CONCLUSIONS: High helpfulness ratings of both booklets suggest that patients benefit from education aids while differences in the booklet ratings suggest that aids are not equally helpful. The CCE booklet, the more helpful booklet of this study, is a systematically developed education aid available to urologists in Canada.

Evaluation of a question-and-answer booklet on early-stage prostate-cancer.

A question-and-answer booklet about early-stage prostate-cancer was created for patients and their family members. Two sequential studies were conducted to determine if the single source of information would be useful to both patients and their families. The first study used 1:1 interviews with 11 readers (6 patients and 5 family members) to identify features of the booklet that may be problematic. In all, six features were identified as either irrelevant or problematic in their design. The second study was a survey of 54 patients (79% response rate) and 33 family members (49% response rate); the study was designed to obtain an overall evaluation of the booklet, to clarify the proportion of readers for whom the features identified in the first study were problematic, to provide insight into how and why readers were reading the booklet, and to determine if patients and family differed on any of the outcomes. Results showed that 85% of readers liked the booklet; most (81.6%) read it from beginning to end. Most readers in both groups wanted the information to help them understand (85.2% patients; 87.9% family); more patients than family wanted it for treatment decision making (44.4% patients; 27.3% family) and for planning (35.2% patients; 9.1% family); more family (42.4%) than patients (20.4%) wanted the information to help them provide support. We conclude that even though patients and family differ in why they want information, the booklet appears to be considered useful by both groups.