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IntroductionMen diagnosed with localized prostate cancer must navigate a highly preference-sensitive decision between treatment options with varying adverse outcome profiles. We evaluated whether use of a decision support tool previously shown to decrease decisional conflict also impacted the secondary outcome of post-treatment decision regret.MethodsParticipants were randomized to receive personalized decision support via the Personal Patient Profile-Prostate or usual care prior to a final treatment decision. Symptoms were measured just before randomization and 6 months later; decision regret was measured at 6 months along with records review to ascertain treatment choices. Regression modeling explored associations between baseline variables including race and D`Amico risk, study group, and 6-month variables regret, choice, and symptoms.ResultsAt 6 months, 287 of 392 (73%) men returned questionnaires of which 257 (89%) had made a treatment choice. Of that group, 201 of 257 (78%) completely answered the regret scale. Regret was not significantly different between participants randomized to the P3P intervention compared to the control group (P = 0.360). In univariate analyses, we found that Black men, men with hormonal symptoms, and men with bowel symptoms reported significantly higher decision regret (all P < 0.01). Significant interactions were detected between race and study group (intervention vs. usual care) in the multivariable model; use of the Personal Patient Profile-Prostate was associated with significantly decreased decisional regret among Black men (P = 0.037). Interactions between regret, symptoms and treatment revealed that (1) men choosing definitive treatment and reporting no hormonal symptoms reported lower regret compared to all others; and (2) men choosing active surveillance and reporting bowel symptoms had higher regret compared to all others.ConclusionThe Personal Patient Profile-Prostate decision support tool may be most beneficial in minimizing decisional regret for Black men considering treatment options for newly-diagnosed prostate cancer.Trial registrationNCT01844999.

Background: Hematopoietic cell transplant (HCT) survivorship care includes recommendations for post‐HCT revaccination to restore immunity to vaccine‐preventable diseases (VPDs). However, not all survivors agree to be vaccinated. No existing studies have comprehensively reported barriers and facilitators to adult HCT survivors completing revaccination. Methods: A cross‐sectional survey of 194 adult HCT survivors was analyzed using convergent mixed methods. The analysis used various statistical methods to determine the prevalence of barriers and facilitators and the association between revaccination and the number and specific type of barriers and facilitators. Content analysis was applied to open‐ended item responses. Integrated analysis merged quantitative and qualitative findings. Results: The most frequent barriers included the inability to receive live vaccines because of immunosuppression, identifying a suitable community location for administering childhood vaccines to adults, and delayed immune recovery. The most frequent facilitators were having healthcare insurance and a clear calendar of the revaccination schedule. Complete revaccination rates were lower with each additional reported barrier (OR = 0.58; 95% CI 0.459–0.722) and higher with each additional reported facilitator (OR = 1.31; 95% CI 1.05–1.63). Content analysis suggested that most barriers were practical issues. One significant facilitator highlighted by respondents was for the transplant center to coordinate and serve as the vaccination location for revaccination services. Merged analysis indicated convergence between quantitative and qualitative data. Conclusion: Practical barriers and facilitators played a consequential role in revaccination uptake, and survivors would like to be revaccinated at the transplant center. [ABSTRACT FROM AUTHOR]

PurposeWe evaluated the efficacy of the web based P3P (Personal Patient Profile-Prostate) decision aid vs usual care with regard to decisional conflict in men with localized prostate cancer.Materials and methodsA randomized (1:1), controlled, parallel group, nonblinded trial was performed in 4 regions of the United States. Eligible men had clinically localized prostate cancer and an upcoming consultation, and they spoke and read English or Spanish. Participants answered questionnaires to report decision making stage, personal characteristics, concerns and preferences plus baseline symptoms and decisional conflict. A randomization algorithm allocated participants to receive tailored education and communication coaching, generic teaching sheets and external websites plus a 1-page summary to clinicians (intervention) or the links plus materials provided in clinic (usual care). Conflict outcomes and the number of consultations were measured at 1 month. Univariate and multivariable models were used to analyze outcomes.ResultsA total of 392 men were randomized, including 198 to intervention and 194 to usual care, of whom 152 and 153, respectively, returned 1-month outcomes. The mean ± SD 1-month decisional conflict scale (score range 0 to 100) was 10.9 ± 16.7 for intervention and 9.9 ± 18.0 for usual care. The multivariable model revealed significantly reduced conflict in the intervention group (-5.00, 95% CI -9.40--0.59). Other predictors of conflict included income, marital or partner status, decision status, number of consultations, clinical site and D'Amico risk classification.ConclusionsIn this multicenter trial the decision aid significantly reduced decisional conflict. Other variables impacted conflict and modified the effect of the decision aid, notably risk classification, consultations and resources. P3P is an effective adjunct for shared decision making in men with localized prostate cancer.

BackgroundPictographs (or pictograms) have been widely utilized to convey medication related messages and to address nonadherence among patients with low health literacy. Yet, patients do not always interpret the intended messages on commonly used pictographs correctly and there are questions how they may be delivered on mobile devices.ObjectiveOur objectives are to refine a set of pictographs to use as medication reminders and to establish preliminary steps for delivery via smart phones.MethodsCard sorting was used to identify existing pictographs that focus group members found "not easy" to understand. Participants then explored improvements to these pictographs while iterations were sketched in real-time by a graphic artist. Feedback was also solicited on how selected pictographs might be delivered via smart phones in a sequential reminder message. The study was conducted at a community learning center that provides literacy services to underserved populations in Seattle, WA. Participants aged 18 years and older who met the criteria for low health literacy using S-TOFHLA were recruited.ResultsAmong the 45 participants screened for health literacy, 29 were eligible and consented to participate. Across four focus group sessions, participants examined 91 commonly used pictographs, 20 of these were ultimately refined to improve comprehensibility using participatory design approaches. All participants in the fifth focus group owned and used cell phones and provided feedback on preferred sequencing of pictographs to represent medication messages.ConclusionLow literacy adults found a substantial number of common medication label pictographs difficult to understand. Participative design processes helped generate new pictographs, as well as feedback on the sequencing of messages on cell phones, that may be evaluated in future research.

BackgroundCastration resistance occurs in most patients with metastatic hormone-sensitive prostate cancer who are receiving androgen-deprivation therapy. Replacing androgens before progression of the disease is hypothesized to prolong androgen dependence.MethodsMen with newly diagnosed, metastatic, hormone-sensitive prostate cancer, a performance status of 0 to 2, and a prostate-specific antigen (PSA) level of 5 ng per milliliter or higher received a luteinizing hormone-releasing hormone analogue and an antiandrogen agent for 7 months. We then randomly assigned patients in whom the PSA level fell to 4 ng per milliliter or lower to continuous or intermittent androgen deprivation, with patients stratified according to prior or no prior hormonal therapy, performance status, and extent of disease (minimal or extensive). The coprimary objectives were to assess whether intermittent therapy was noninferior to continuous therapy with respect to survival, with a one-sided test with an upper boundary of the hazard ratio of 1.20, and whether quality of life differed between the groups 3 months after randomization.ResultsA total of 3040 patients were enrolled, of whom 1535 were included in the analysis: 765 randomly assigned to continuous androgen deprivation and 770 assigned to intermittent androgen deprivation. The median follow-up period was 9.8 years. Median survival was 5.8 years in the continuous-therapy group and 5.1 years in the intermittent-therapy group (hazard ratio for death with intermittent therapy, 1.10; 90% confidence interval, 0.99 to 1.23). Intermittent therapy was associated with better erectile function and mental health (P

BackgroundRecruitment of health research participants through social media is becoming more common. In the United States, 80% of adults use at least one social media platform. Social media platforms may allow researchers to reach potential participants efficiently. However, online research methods may be associated with unique threats to sample validity and data integrity. Limited research has described issues of data quality and authenticity associated with the recruitment of health research participants through social media, and sources of low-quality and fraudulent data in this context are poorly understood. ObjectiveThe goal of the research was to describe and explain threats to sample validity and data integrity following recruitment of health research participants through social media and summarize recommended strategies to mitigate these threats. Our experience designing and implementing a research study using social media recruitment and online data collection serves as a case study. MethodsUsing published strategies to preserve data integrity, we recruited participants to complete an online survey through the social media platforms Twitter and Facebook. Participants were to receive $15 upon survey completion. Prior to manually issuing remuneration, we reviewed completed surveys for indicators of fraudulent or low-quality data. Indicators attributable to respondent error were labeled suspicious, while those suggesting misrepresentation were labeled fraudulent. We planned to remove cases with 1 fraudulent indicator or at least 3 suspicious indicators. ResultsWithin 7 hours of survey activation, we received 271 completed surveys. We classified 94.5% (256/271) of cases as fraudulent and 5.5% (15/271) as suspicious. In total, 86.7% (235/271) provided inconsistent responses to verifiable items and 16.2% (44/271) exhibited evidence of bot automation. Of the fraudulent cases, 53.9% (138/256) provided a duplicate or unusual response to one or more open-ended items and 52.0% (133/256) exhibited evidence of inattention. ConclusionsResearch findings from several disciplines suggest studies in which research participants are recruited through social media are susceptible to data quality issues. Opportunistic individuals who use virtual private servers to fraudulently complete research surveys for profit may contribute to low-quality data. Strategies to preserve data integrity following research participant recruitment through social media are limited. Development and testing of novel strategies to prevent and detect fraud is a research priority.