Patient-Centered Preference Assessment to Improve Satisfaction With Care Among Patients With Localized Prostate Cancer: A Randomized Controlled Trial.

PURPOSE: To study the effectiveness of the Patient Preferences for Prostate Cancer Care (PreProCare) intervention in improving the primary outcome of satisfaction with care and secondary outcomes of satisfaction with decision, decision regret, and treatment choice among patients with localized prostate cancer. METHODS: In this multicenter randomized controlled study, we randomly assigned patients with localized prostate cancer to the PreProCare intervention or usual care. Outcomes were satisfaction with care, satisfaction with decision, decision regret, and treatment choice. Assessments were performed at baseline and at 3, 6, 12, and 24 months, and were analyzed using repeated measures. We compared treatment choice across intervention groups by prostate cancer risk categories. RESULTS: Between January 2014 and March 2015, 743 patients with localized prostate cancer were recruited and randomly assigned to receive PreProCare (n = 372) or usual care (n = 371). For the general satisfaction subscale, improvement at 24 months from baseline was significantly different between groups (P < .001). For the intervention group, mean scores at 24 months improved by 0.44 (SE, 0.06; P < .001) from baseline. This improvement was 0.5 standard deviation, which was clinically significant. The proportion reporting satisfaction with decision and no regret increased over time and was higher for the intervention group, compared with the usual care group at 24 months (P < .05). Among low-risk patients, a higher proportion of the intervention group was receiving active surveillance, compared with the usual care group (P < .001). CONCLUSION: Our patient-centered PreProCare intervention improved satisfaction with care, satisfaction with decision, reduced regrets, and aligned treatment choice with risk category. The majority of our participants had a high income, with implications for generalizability. Additional studies can evaluate the effectiveness of PreProCare as a mechanism for improving clinical and patient-reported outcomes in different settings.

Surgical Consultation as Social Process: Implications for Shared Decision Making.

OBJECTIVE: This qualitative study examines surgical consultation as a social process and assesses its alignment with assumptions of the shared decision-making (SDM) model. SUMMARY OF BACKGROUND DATA: SDM stresses the importance of patient preferences and rigorous discussion of therapeutic risks/benefits based on these preferences. However, empirical studies have highlighted discrepancies between SDM and realities of surgical decision making. Qualitative research can inform understanding of the decision-making process and allow for granular assessment of the nature and causes of these discrepancies. METHODS: We observed consultations between 3 general surgeons and 45 patients considering undergoing 1 of 2 preference-sensitive elective operations: (1) hernia repair, or (2) cholecystectomy. These patients and surgeons also participated in semi-structured interviews. RESULTS: By the time of the consultation, patients and surgeons were predisposed toward certain decisions by preceding events occurring elsewhere. During the visit, surgeons had differential ability to arbitrate surgical intervention and construct the severity of patients' conditions. These upstream dynamics frequently displaced the centrality of the risk/benefit-based consent discussion. CONCLUSION: The influence of events preceding consultation suggests that decision-making models should account for broader spatiotemporal spans. Given surgeons' authority to define patients' conditions and control service provision, SDM may be premised on an overestimation of patients' power to alter the course of decision making once in a specialist's office. Considering the subordinate role of the risk/benefit discussion in many surgical decisions, it will be important to study if and how the social process of decision making is altered by SDM-oriented decision aids that foreground this discussion.

Impact of Cost Sharing on Therapeutic Substitution: The Story of Statins in 2006.

BACKGROUND: Cost sharing is widely used to encourage therapeutic substitution. This study aimed to examine the impact of increases in patient cost-sharing differentials for brand name and generic drugs on statin utilization on entry into the Medicare Part D coverage gap. METHOD AND RESULTS: Using 5% Medicare Chronic Condition Warehouse files from 2006, this quasi-experimental study examined patients with hyperlipidemia who filled prescriptions for atorvastatin or rosuvastatin between January and March 2006. Propensity score matching and difference-in-difference regressions were used to compare changes in statin utilization for the study group (patients who were not eligible for low-income subsidies [non-LIS] and had generic-only gap coverage) to those of a control group (LIS patients who faced the same cost sharing before and during the Part D coverage gap). In the final sample, 801 patients in the study group were matched to 801 patients in the control group. We found that, compared to the control group, the study group had a larger decline in any monthly brand-name statin use (-0.24 30-day fills, P<0.001). This was only partially offset by increased monthly generic statin use (+0.06 30-day fill, P<0.001), with an overall drop in any monthly statin use (-0.18 30-day fills, P<0.001). Overall adherence with statins declined (OR 0.81, P<0.001), and statin discontinuation increased (OR 1.62, P<0.001) in the study group as compared to the control group. CONCLUSIONS: Increases in cost-sharing differentials for brand name and generic drugs on coverage gap entry were associated with discontinuation of statins in Medicare Part D patients with hyperlipidemia.

Validity of utility measures for women with urge, stress, and mixed urinary incontinence.

OBJECTIVE: We sought to evaluate the construct validity of 3 health status classification system instruments-Health Utilities Index Mark 3 (HUI-3), EuroQol (EQ-5D), and Short Form 6D (SF-6D)-and a visual analog scale (VAS) for measuring utility scores in women with urge, stress, and mixed urinary incontinence. STUDY DESIGN: Utility scores were measured in 202 women with urinary incontinence. Pelvic floor symptom severity and quality of life were measured using the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire, respectively. Construct, discriminant, and concurrent validity were evaluated. RESULTS: Significant correlations were noted between utility scores and the Pelvic Floor Distress Inventory (r = -0.22 to -0.42, P < .05) and the Pelvic Floor Impact Questionnaire (r = -0.32 to -0.50, P < .05). Mean utility scores were significantly lower for women with urge or mixed incontinence compared to stress incontinence for the EQ-5D (0.71 ± 0.23, 0.73 ± 0.26, and 0.81 ± 0.16, respectively, P = .02) and the SF-6D (0.76 ± 0.12, 0.74 ± 0.12, and 0.81 ± 0.11, respectively, P = .02) but not the HUI-3 or the VAS. There was a clinically important difference in utility scores (>0.03) between women with urge or mixed incontinence as compared to stress incontinence for the HUI-3, EQ-5D, and SF-6D but not the VAS. Utility preference scores were significantly lower for women with combined urinary and fecal incontinence (0.69-0.73) than urinary incontinence alone (0.77-0.84, P < .01). CONCLUSION: The HUI-3, EQ-5D, and SF-6D, but not the VAS, provide valid measurements for utility scores in women with stress, urge, and mixed urinary incontinence.