Changes over Time in Patient Stated Values and Treatment Preferences Regarding Aggressive Therapies: Insights from the DECIDE-LVAD Trial.

BACKGROUND: Patient-centered care includes matching treatments to patient values and preferences. This assumes clarity and consistency of values and preferences relevant to major medical decisions. We sought to describe stability of patient-reported values regarding aggressiveness of care and preferences for left ventricular assist devices (LVADs) for advanced heart failure. METHODS AND RESULTS: We conducted a secondary analysis of patients undergoing LVAD evaluation at 6 US centers. Surveys at baseline, 1 month, and 6 months included a single 10-point scale on the value of aggressive care (score 1 = "do everything," 10 = "live with whatever time I have left") and treatment preference (LVAD, unsure, no LVAD). Data were captured for 232 patients, of whom 196 were ultimately deemed medically eligible for LVAD, and 161 were surgically implanted by 1 month. Values at baseline favored aggressive care (mean [SD], 2.49 [2.63]), trending toward less aggressive over time (1 month, 2.63 [2.05]; 6 months, 3.22 [2.70]). Between baseline and 1 month, values scores changed by ≥2 points in 28% (50/176), as did treatment preferences for 18% (29/161) of patients. Values score changes over time were associated with lower illness acceptance, depression, and eventual LVAD ineligibility. Treatment preference change was associated with values score change. CONCLUSION: Most patients considering LVAD were stable in their values and treatment preferences. This stability, as well as the association between unstable treatment preferences and changes to stated values, highlighted the clinical utility of the values scale of aggressiveness. However, a substantial minority reported significant changes over time that may complicate the process of shared decision making. Improved methods to elicit and clarify values, including support to those with depression and low illness acceptance, is critical for patient-centered care.[Box: see text].

Comparison of weekly and daily recall of pain as an endpoint in a randomized phase 3 trial of cabozantinib for metastatic castration-resistant prostate cancer.

INTRODUCTION: Scant evidence reveals whether the use of weekly versus daily pain ratings leads to meaningful differences when measuring pain as a clinical trial outcome. We compared the ability of weekly ratings and descriptors of daily ratings to evaluate pain as an endpoint in a randomized phase 3 drug trial. METHODS: Participants (n = 119) with metastatic castration-resistant prostate cancer were randomized to treatment arms and rated their pain on the average and at its worst during a baseline week and at weeks 3, 6, and 12 of study treatment. For each reporting period, participants rated their pain daily for 7 days. On day 7, participants rated their pain over the prior 7 days. We estimated mean differences and intraclass correlation coefficients of the weekly ratings and the mean and the maximum daily ratings. We compared the ability of the weekly ratings and the daily rating descriptors to detect change in pain and evaluated the agreement of the weekly rating and the mean daily rating of pain at its worst to detect treatment response. RESULTS: For both pain constructs, the weekly rating was consistently higher than the mean daily rating and lower than the maximum daily rating yet was moderately to highly correlated with both daily rating descriptors (intraclass correlation coefficient range = 0.55-0.94). The weekly rating and the daily rating descriptors consistently detected change in pain for the study sample and participant subgroups. Substantial agreement existed between the weekly rating and the mean daily rating of pain at its worst when used with trial protocol opioid criteria to detect treatment response (Cohen's κ = 0.71). CONCLUSION: Use of daily over weekly ratings delivered no added benefit in evaluating pain in this clinical trial. This study is the first to compare weekly and daily recall to measure pain as an endpoint in a randomized phase 3 drug trial, and the pattern of differences in ratings that we observed is consistent with other recent evaluations of weekly and daily symptom reporting.

Planning prompts to promote uptake of HIV services among men: a randomised trial in rural Uganda.

INTRODUCTION: Interventions informed by behavioural economics, such as planning prompts, have the potential to increase HIV testing at minimal or no cost. Planning prompts have not been previously evaluated for HIV testing uptake. We conducted a randomised clinical trial to evaluate the effectiveness of low-cost planning prompts to promote HIV testing among men. METHODS: We randomised adult men in rural Ugandan parishes to receive a calendar planning prompt that gave them the opportunity to make a plan to get tested for HIV at health campaigns held in their communities. Participants received either a calendar showing the dates when the community health campaign would be held (control group) or a calendar showing the dates and prompting them to select a date and time when they planned to attend (planning prompt group). Participants were not required to select a date and time or to share their selection with study staff. The primary outcome was HIV testing uptake at the community health campaign. RESULTS: Among 2362 participants, 1796 (76%) participants tested for HIV. Men who received a planning prompt were 2.2 percentage points more likely to test than the control group, although the difference was not statistically significant (77.1% vs 74.9%; 95% CI -1.2 to 5.7 percentage points, p=0.20). The planning prompt was more effective among men enrolled ≤40 days before the campaigns (3.6 percentage-point increase in testing; 95% CI -2.9 to 10.1, p=0.27) than among men enrolled >40 days before the campaigns (1.8 percentage-point increase; 95% CI -2.3 to 5.8, p=0.39), although the effects within the subgroups were not significant. CONCLUSION: These findings suggest that planning prompts may be an effective behavioural intervention to promote HIV testing at minimal or no cost. Large-scale studies should further assess the impact and cost-effectiveness of such interventions.

Promoting HIV Testing by Men: A Discrete Choice Experiment to Elicit Preferences and Predict Uptake of Community-based Testing in Uganda.

BACKGROUND AND OBJECTIVES: HIV testing is essential to access HIV treatment and care and plays a critical role in preventing transmission. Despite this, testing coverage is low among men in sub-Saharan Africa. Community-based testing has demonstrated potential to expand male testing coverage, yet scant evidence reveals how community-based services can be designed to optimize testing uptake. We conducted a discrete choice experiment (DCE) to elicit preferences and predict uptake of community-based testing by men in Uganda. METHODS: Hypothetical choices between alternative community-based testing services and the option to opt-out of testing were presented to a random, population-based sample of 203 adult male residents. The testing alternatives varied by service delivery model (community health campaign, counselor-administered home-based testing, distribution of HIV self-test kits at local pharmacies), availability of multi-disease testing, access to antiretroviral therapy (ART), and provision of a US$0.85 incentive. We estimated preferences using a random parameters logit model and explored whether preferences varied by participant characteristics through subgroup analyses. We simulated uptake when a single and when two community-based testing services are made available, using reference values of observed uptake to calibrate predictions. RESULTS: The share of the adult male population predicted to test for HIV ranged from 0.15 to 0.91 when a single community-based testing service is made available and from 0.50 to 0.96 when two community-based services are provided concurrently. ART access was the strongest driver of choices (relative importance [RI] = 3.01, 95% confidence interval [CI]: 1.74-4.29), followed by the service delivery model (RI = 1.27, 95% CI 0.72-1.82) and availability of multi-disease testing (RI = 1.27, 95% CI 0.09-2.45). A US$0.85 incentive had the least yet still significant influence on choices (RI = 0.77, 95% CI 0.06-1.49). Men who perceived their risk of having HIV to be relatively elevated had higher predicted uptake of HIV self-test kits at local pharmacies, as did young adult men compared to men aged ≥ 30 years. Men who earned ≤ the daily median income had higher predicted uptake of all community-based testing services versus men who earned above the daily median income. CONCLUSION: Substantial opportunity exists to optimize the delivery of HIV testing to expand uptake by men; using an innovative DCE, we deliver timely, actionable guidance for promoting community-based testing by men in Uganda. We advance the stated preference literature methodologically by describing how we constructed and evaluated a pragmatic experimental design, used interaction terms to conduct subgroup analyses, and harnessed participant-specific preference estimates to predict and calibrate testing uptake.

Comparative effectiveness of novel nonmonetary incentives to promote HIV testing.

OBJECTIVE: To assess the comparative effectiveness of alternative incentive-based interventions to promote HIV testing among men. DESIGN: Randomized clinical trial. METHODS: We enumerated four Ugandan parishes and enrolled men at least 18 years. Participants were randomized to six groups that received incentives of varying type and amount for HIV testing at a 13-day community health campaign. Incentive types were: gain-framed (control): participants were told they would receive a prize for testing; loss-framed: participants were told they had won a prize, shown several prizes, asked to select one, then told they would lose the prize if they did not test; lotteries: those who tested had a chance to win larger prizes. Each incentive type had a low and high amount (∼US$1 and US$5/participant). The primary outcome was HIV-testing uptake at the community health campaign. RESULTS: Of 2532 participants, 1924 (76%) tested for HIV; 7.6% of those tested were HIV-positive. There was no significant difference in testing uptake in the two lottery groups (78%; P = 0.076) or two loss-framed groups (77%; P = 0.235) vs. two gain-framed groups (74%). Across incentive types, testing did not differ significantly in high-cost (76%) vs. low-cost (75%; P = 0.416) groups. Within low-cost groups, testing uptake was significantly higher in the lottery (80%) vs. gain-framed (72%; P = 0.009) group. CONCLUSION: Overall, neither offering incentives via lotteries nor framing incentives as losses resulted in significant increases in HIV testing compared with standard gain-framed incentives. However, when offering low-cost incentives to promote HIV testing, providing lottery-based rewards may be a better strategy than gain-framed incentives.

Adding bevacizumab to single agent chemotherapy for the treatment of platinum-resistant recurrent ovarian cancer: A cost effectiveness analysis of the AURELIA trial.

OBJECTIVE: AURELIA, a randomized phase III trial of adding bevacizumab (B) to single agent chemotherapy (CT) for the treatment of platinum-resistant recurrent ovarian cancer, demonstrated improved progression free survival (PFS) in the B+CT arm compared to CT alone. We aimed to evaluate the cost effectiveness of adding B to CT in the treatment of platinum-resistant recurrent ovarian cancer. METHODS: A decision tree model was constructed to evaluate the cost effectiveness of adding bevacizumab (B) to single agent chemotherapy (CT) based on the arms of the AURELIA trial. Costs, quality-adjusted life years (QALYs), and progression free survival (PFS) were modeled over fifteen months. Model inputs were extracted from published literature and public sources. Incremental cost effectiveness ratios (ICERs) per QALY gained and ICERs per progression free life year saved (PF-LYS) were calculated. One-way sensitivity analyses were performed to evaluate the robustness of results. RESULTS: The ICER associated with B+CT is $410,455 per QALY gained and $217,080 per PF-LYS. At a willingness to pay (WTP) threshold of $50,000/QALY, adding B to single agent CT is not cost effective for this patient population. Even at a WTP threshold of $100,000/QALY, B+CT is not cost effective. These findings are robust to sensitivity analyses. CONCLUSIONS: Despite gains in QALY and PFS, the addition of B to single agent CT for treatment of platinum-resistant recurrent ovarian cancer is not cost effective. Benefits, risks, and costs associated with treatment should be taken into consideration when prescribing chemotherapy for this patient population.