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Informational needs during active surveillance for prostate cancer: A qualitative study
Loeb, Stacy; Curnyn, Caitlin; Fagerlin, Angela; Braithwaite, R Scott; Schwartz, Mark D; Lepor, Herbert; Carter, H Ballentine; Ciprut, Shannon; Sedlander, Erica
OBJECTIVE:To understand the informational needs during active surveillance (AS) for prostate cancer from the perspectives of patients and providers. METHODS:We conducted seven focus groups with 37 AS patients in two urban clinical settings, and 24 semi-structured interviews with a national sample of providers. Transcripts were analyzed using applied thematic analysis, and themes were organized using descriptive matrix analyses. RESULTS:We identified six themes related to informational needs during AS: 1) more information on prostate cancer (biopsy features, prognosis), 2) more information on active surveillance (difference from watchful waiting, testing protocol), 3) more information on alternative management options (complementary medicine, lifestyle modification), 4) greater variety of resources (multiple formats, targeting different audiences), 5) more social support and interaction, and 6) verified integrity of information (trusted, multidisciplinary and secure). CONCLUSIONS:Patients and providers described numerous drawbacks to existing prostate cancer resources and a variety of unmet needs including information on prognosis, AS testing protocols, and lifestyle modification. They also expressed a need for different types of resources, including interaction and unbiased information. PRACTICAL IMPLICATIONS/CONCLUSIONS:These results are useful to inform the design of future resources for men undergoing AS.
PMCID:5808852
PMID: 28886974
ISSN: 1873-5134
CID: 2888782
A Randomized Study of Patient Risk Perception for Incidental Renal Findings on Diagnostic Imaging Tests
Kang, Stella K; Scherer, Laura D; Megibow, Alec J; Higuita, Leslie J; Kim, Nathanael; Braithwaite, R Scott; Fagerlin, Angela
OBJECTIVE: The purpose of this study is to assess differences in patient distress, risk perception, and treatment preferences for incidental renal findings with descriptive versus combined descriptive and numeric graphical risk information. MATERIALS AND METHODS: A randomized survey study was conducted for adult patients about to undergo outpatient imaging studies at a large urban academic institution. Two survey arms contained either descriptive or a combination of descriptive and numeric graphical risk information about three hypothetical incidental renal findings at CT: 2-cm (low risk) and 5-cm (high risk) renal tumors and a 2-cm (low risk) renal artery aneurysm. The main outcomes were patient distress, perceived risk (qualitative and quantitative), treatment preference, and valuation of lesion discovery. RESULTS: Of 374 patients, 299 participated (79.9% response rate). With inclusion of numeric and graphical, rather than only descriptive, risk information about disease progression for a 2-cm renal tumor, patients reported less worry (3.56 vs 4.12 on a 5-point scale; p < 0.001) and favored surgical consultation less often (29.3% vs 46.9%; p = 0.003). The proportion choosing surgical consultation for the 2-cm renal tumor decreased to a similar level as for the renal artery aneurysm with numeric risk information (29.3% [95% CI, 21.7-36.8%] and 27.9% [95% CI, 20.5-35.3%], respectively). Patients overestimated the absolute risk of adverse events regardless of risk information type, but significantly more so when given descriptive information only, and valued the discovery of lesions regardless of risk information type (range, 4.41-4.81 on a 5-point scale). CONCLUSION: Numeric graphical risk communication for patients about incidental renal lesions may facilitate accurate risk comprehension and support patients in informed decision making.
PMCID:5876026
PMID: 29140116
ISSN: 1546-3141
CID: 2785282
Cost-Effectiveness Of Peer- Versus Venue-Based Approaches For Detecting Undiagnosed Hiv Among Heterosexuals In High-Risk New York City Neighborhoods
Stevens, Elizabeth R; Nucifora, Kimberly; Zhou, Qinlian; Braithwaite, R Scott; Cleland, Charles M; Ritchie, Amanda S; Kutnick, Alexandra H; Gwadz, Marya V
INTRODUCTION: We used a computer simulation of HIV progression and transmission to evaluate the cost-effectiveness of a scale-up of three strategies to seek out and test individuals with undiagnosed HIV in New York City (NYC). SETTING: Hypothetical NYC population METHODS:: We incorporated the observed effects and costs of the three "seek and test" strategies in a computer simulation of HIV in NYC, comparing a scenario in which the strategies were scaled up with a one-year implementation or a long-term implementation with a counterfactual scenario with no scale-up. The simulation combined a deterministic compartmental model of HIV transmission with a stochastic microsimulation of HIV progression, calibrated to NYC epidemiological data from 2003 to 2015. The three approaches were respondent driven sampling (RDS) with anonymous HIV testing ("RDS-A"), RDS with a two-session confidential HIV testing approach ("RDS-C"), and venue-based sampling ("VBS"). RESULTS: RDS-A was the most cost-effective strategy tested. When implemented for only one year and then stopped thereafter, using a societal perspective, the cost per quality-adjusted life-year (QALY) gained versus no intervention was $812/QALY, $18,110/QALY, and $20,362/QALY for RDS-A, RDS-C, and VBS, respectively. When interventions were implemented long-term, the cost per QALY gained versus no intervention was cost-saving, $31,773/QALY, and $35,148/QALY for RDS-A, RDS-C, and VBS, respectively. When compared to RDS-A the incremental cost effectiveness ratios (ICERs) for both VBS and RDS-C were dominated. CONCLUSION: The expansion of the RDS-A strategy would substantially reduce HIV-related deaths and new HIV infections in NYC, and would be either cost-saving or have favorable cost-effectiveness.
PMCID:5762425
PMID: 29135654
ISSN: 1944-7884
CID: 2785342
Active Surveillance Versus Watchful Waiting for Localized Prostate Cancer: A Model to Inform Decisions
Loeb, Stacy; Zhou, Qinlian; Siebert, Uwe; Rochau, Ursula; Jahn, Beate; Mühlberger, Nikolai; Carter, H Ballentine; Lepor, Herbert; Braithwaite, R Scott
BACKGROUND:An increasing proportion of prostate cancer is being managed conservatively. However, there are no randomized trials or consensus regarding the optimal follow-up strategy. OBJECTIVE:To compare life expectancy and quality of life between watchful waiting (WW) versus different strategies of active surveillance (AS). DESIGN, SETTING, AND PARTICIPANTS/METHODS:A Markov model was created for US men starting at age 50, diagnosed with localized prostate cancer who chose conservative management by WW or AS using different testing protocols (prostate-specific antigen every 3-6 mo, biopsy every 1-5 yr, or magnetic resonance imaging based). Transition probabilities and utilities were obtained from the literature. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS/UNASSIGNED:Primary outcomes were life years and quality-adjusted life years (QALYs). Secondary outcomes include radical treatment, metastasis, and prostate cancer death. RESULTS AND LIMITATIONS/CONCLUSIONS:All AS strategies yielded more life years compared with WW. Lifetime risks of prostate cancer death and metastasis were, respectively, 5.42% and 6.40% with AS versus 8.72% and 10.30% with WW. AS yielded more QALYs than WW except in cohorts age >65 yr at diagnosis, or when treatment-related complications were long term. The preferred follow-up strategy was also sensitive to whether people value short-term over long-term benefits (time preference). Depending on the AS protocol, 30-41% underwent radical treatment within 10 yr. Extending the surveillance biopsy interval from 1 to 5 yr reduced life years slightly, with a 0.26 difference in QALYs. CONCLUSIONS:AS extends life more than WW, particularly for men with higher-risk features, but this is partly offset by the decrement in quality of life since many men eventually receive treatment. PATIENT SUMMARY/UNASSIGNED:More intensive active surveillance protocols extend life more than watchful waiting, but this is partly offset by decrements in quality of life from subsequent treatment.
PMCID:5694372
PMID: 28844371
ISSN: 1873-7560
CID: 3070402
Effects of naloxone distribution alone or in combination with addiction treatment with or without pre-exposure prophylaxis for HIV prevention in people who inject drugs: a cost-effectiveness modelling study
Uyei, Jennifer; Fiellin, David A; Buchelli, Marianne; Rodriguez-Santana, Ramon; Braithwaite, R Scott
BACKGROUND:In the USA, an epidemic of opioid overdose deaths is occurring, many of which are from heroin. Combining naloxone distribution with linkage to addiction treatment or pre-exposure prophylaxis (PrEP) for HIV prevention through syringe service programmes has the potential to save lives and be cost-effective. We estimated the outcomes and cost-effectiveness of five alternative strategies: no additional intervention, naloxone distribution, naloxone distribution plus linkage to addiction treatment, naloxone distribution plus PrEP, and naloxone distribution plus linkage to addiction treatment and PrEP. METHODS:We developed a decision analytical Markov model to simulate opioid overdose, HIV incidence, overdose-related deaths, and HIV-related deaths in people who inject drugs in Connecticut, USA. Model input parameters were derived from published sources. We compared each strategy with no intervention, as well as simultaneously considering all strategies. Sensitivity analysis was done for all variables. Linkage to addiction treatment was referral to an opioid treatment programme for methadone. Endpoints were survival, life expectancy, quality-adjusted life-years (QALYs), number and percentage of overdose deaths averted, number of HIV-related deaths averted, total costs (in 2015 US$) associated with each strategy, and incremental cost per QALY gained. FINDINGS/RESULTS:In the base-case analysis, compared with no additional intervention, the naloxone distribution strategy yielded an incremental cost-effectiveness ratio (ICER) of $323 per QALY, and naloxone distribution plus linkage to addiction treatment was cost saving compared with no additional intervention (greater effectiveness and less expensive). The most efficient strategies (ie, those conferring the greatest health benefit for a particular budget) were naloxone distribution combined with linkage to addiction treatment (cost saving), and naloxone distribution combined with PrEP and linkage to addiction treatment (ICER $95 337 per QALY) at a willingness-to-pay threshold of $100 000. In probabilistic sensitivity analysis, the combination of naloxone distribution, PrEP, and linkage to addiction treatment was the optimal strategy in 37% of iterations and the combination of naloxone distribution and linkage to addiction treatment was the optimal strategy in 34% of iterations. INTERPRETATION/CONCLUSIONS:Naloxone distribution through syringe service programmes is cost-effective compared with syringe distribution alone, but when combined with linkage to addiction treatment is cost saving compared with no additional services. A strategy that combines naloxone distribution, PrEP, and linkage to addiction treatment results in greater health benefits in people who inject drugs and is also cost-effective. FUNDING/BACKGROUND:State of Connecticut Department of Public Health and the National Institute of Mental Health.
PMID: 29253386
ISSN: 2468-2667
CID: 2892592
Is more research always needed? Estimating optimal sample sizes for trials of retention in care interventions for HIV-positive East Africans
Uyei, Jennifer; Li, Lingfeng; Braithwaite, R Scott
INTRODUCTION: Given the serious health consequences of discontinuing antiretroviral therapy, randomised control trials of interventions to improve retention in care may be warranted. As funding for global HIV research is finite, it may be argued that choices about sample size should be tied to maximising health. METHODS: For an East African setting, we calculated expected value of sample information and expected net benefit of sampling to identify the optimal sample size (greatest return on investment) and to quantify net health gains associated with research. Two hypothetical interventions were analysed: (1) one aimed at reducing disengagement from HIV care and (2) another aimed at finding/relinking disengaged patients. RESULTS: When the willingness to pay (WTP) threshold was within a plausible range (1-3 x GDP; US$1377-4130/QALY), the optimal sample size was zero for both interventions, meaning that no further research was recommended because the pre-research probability of an intervention's effectiveness and value was sufficient to support a decision on whether to adopt the intervention and any new information gained from additional research would likely not change that decision. In threshold analyses, at a higher WTP of $5200 the optimal sample size for testing a risk reduction intervention was 2750 per arm. For the outreach intervention, the optimal sample size remained zero across a wide range of WTP thresholds and was insensitive to variation. Limitations, including not varying all inputs in the model, may have led to an underestimation of the value of investing in new research. CONCLUSION: In summary, more research is not always needed, particularly when there is moderately robust prestudy belief about intervention effectiveness and little uncertainty about the value (cost-effectiveness) of the intervention. Users can test their own assumptions at http://torchresearch.org.
PMCID:5656134
PMID: 29081993
ISSN: 2059-7908
CID: 2765132
Potential return on investment of a family-centered early childhood intervention: a cost-effectiveness analysis
Hajizadeh, Negin; Stevens, Elizabeth R; Applegate, Melanie; Huang, Keng-Yen; Kamboukos, Dimitra; Braithwaite, R Scott; Brotman, Laurie M
BACKGROUND: ParentCorps is a family-centered enhancement to pre-kindergarten programming in elementary schools and early education centers. When implemented in high-poverty, urban elementary schools serving primarily Black and Latino children, it has been found to yield benefits in childhood across domains of academic achievement, behavior problems, and obesity. However, its long-term cost-effectiveness is unknown. METHODS: We determined the cost-effectiveness of ParentCorps in high-poverty, urban schools using a Markov Model projecting the long-term impact of ParentCorps compared to standard pre-kindergarten programming. We measured costs and quality adjusted life years (QALYs) resulting from the development of three disease states (i.e., drug abuse, obesity, and diabetes); from the health sequelae of these disease states; from graduation from high school; from interaction with the judiciary system; and opportunity costs of unemployment with a lifetime time horizon. The model was built, and analyses were performed in 2015-2016. RESULTS: ParentCorps was estimated to save $4387 per individual and increase each individual's quality adjusted life expectancy by 0.27 QALYs. These benefits were primarily due to the impact of ParentCorps on childhood obesity and the subsequent predicted prevention of diabetes, and ParentCorps' impact on childhood behavior problems and the subsequent predicted prevention of interaction with the judiciary system and unemployment. Results were robust on sensitivity analyses, with ParentCorps remaining cost saving and health generating under nearly all assumptions, except when schools had very small pre-kindergarten programs. CONCLUSIONS: Effective family-centered interventions early in life such as ParentCorps that impact academic, behavioral and health outcomes among children attending high-poverty, urban schools have the potential to result in longer-term health benefits and substantial cost savings.
PMCID:5635549
PMID: 29017527
ISSN: 1471-2458
CID: 2731682
Observational Study of the Effect of Patient Outreach on Return to Care: The Earlier the Better
Rebeiro, Peter F; Bakoyannis, Giorgos; Musick, Beverly S; Braithwaite, Ronald S; Wools-Kaloustian, Kara K; Nyandiko, Winstone; Some, Fatma; Braitstein, Paula; Yiannoutsos, Constantin T
BACKGROUND: The burden of HIV remains heaviest in resource-limited settings, where problems of losses to care, silent transfers, gaps in care, and incomplete mortality ascertainment have been recognized. METHODS: Patients in care at Academic Model Providing Access to Healthcare (AMPATH) clinics from 2001-2011 were included in this retrospective observational study. Patients missing an appointment were traced by trained staff; those found alive were counseled to return to care (RTC). Relative hazards of RTC were estimated among those having a true gap: missing a clinic appointment and confirmed as neither dead nor receiving care elsewhere. Sample-based multiple imputation accounted for missing vital status. RESULTS: Among 34,522 patients lost to clinic, 15,331 (44.4%) had a true gap per outreach, 2754 (8.0%) were deceased, and 837 (2.4%) had documented transfers. Of 15,600 (45.2%) remaining without active ascertainment, 8762 (56.2%) with later RTC were assumed to have a true gap. Adjusted cause-specific hazard ratios (aHRs) showed early outreach (a =8-day window, defined by grid-search approach) had twice the hazard for RTC vs. those without (aHR = 2.06; P < 0.001). HRs for RTC were lower the later the outreach effort after disengagement (aHR = 0.86 per unit increase in time; P < 0.001). Older age, female sex (vs. male), antiretroviral therapy use (vs. none), and HIV status disclosure (vs. none) were also associated with greater likelihood of RTC, and higher enrollment CD4 count with lower likelihood of RTC. CONCLUSION: Patient outreach efforts have a positive impact on patient RTC, regardless of when undertaken, but particularly soon after the patient misses an appointment.
PMCID:5597469
PMID: 28604501
ISSN: 1944-7884
CID: 2701762
Betting on the fastest horse: Using computer simulation to design a combination HIV intervention for future projects in Maharashtra, India
Ruggles, Kelly V; Patel, Anik R; Schensul, Stephen; Schensul, Jean; Nucifora, Kimberly; Zhou, Qinlian; Bryant, Kendall; Braithwaite, R Scott
OBJECTIVE: To inform the design of a combination intervention strategy targeting HIV-infected unhealthy alcohol users in Maharashtra, India, that could be tested in future randomized control trials. METHODS: Using probabilistic compartmental simulation modeling we compared intervention strategies targeting HIV-infected unhealthy alcohol users on antiretroviral therapy (ART) in Maharashtra, India. We tested interventions targeting four behaviors (unhealthy alcohol consumption, risky sexual behavior, depression and antiretroviral adherence), in three formats (individual, group based, community) and two durations (shorter versus longer). A total of 5,386 possible intervention combinations were tested across the population for a 20-year time horizon and intervention bundles were narrowed down based on incremental cost-effectiveness analysis using a two-step probabilistic uncertainty analysis approach. RESULTS: Taking into account uncertainty in transmission variables and intervention cost and effectiveness values, we were able to reduce the number of possible intervention combinations to be used in a randomized control trial from over 5,000 to less than 5. The most robust intervention bundle identified was a combination of three interventions: long individual alcohol counseling; weekly Short Message Service (SMS) adherence counseling; and brief sex risk group counseling. CONCLUSIONS: In addition to guiding policy design, simulation modeling of HIV transmission can be used as a preparatory step to trial design, offering a method for intervention pre-selection at a reduced cost.
PMCID:5584966
PMID: 28873452
ISSN: 1932-6203
CID: 2687672
Community-Based, Preclinical Patient Navigation for Colorectal Cancer Screening Among Older Black Men Recruited From Barbershops: The MISTER B Trial
Cole, Helen; Thompson, Hayley S; White, Marilyn; Browne, Ruth; Trinh-Shevrin, Chau; Braithwaite, Scott; Fiscella, Kevin; Boutin-Foster, Carla; Ravenell, Joseph
OBJECTIVES: To test the effectiveness of a preclinical, telephone-based patient navigation intervention to encourage colorectal cancer (CRC) screening among older Black men. METHODS: We conducted a 3-parallel-arm, randomized trial among 731 self-identified Black men recruited at barbershops between 2010 and 2013 in New York City. Participants had to be aged 50 years or older, not be up-to-date on CRC screening, have uncontrolled high blood pressure, and have a working telephone. We randomized participants to 1 of 3 groups: (1) patient navigation by a community health worker for CRC screening (PN), (2) motivational interviewing for blood pressure control by a trained counselor (MINT), or (3) both interventions (PLUS). We assessed CRC screening completion at 6-month follow-up. RESULTS: Intent-to-treat analysis revealed that participants in the navigation interventions were significantly more likely than those in the MINT-only group to be screened for CRC during the 6-month study period (17.5% of participants in PN, 17.8% in PLUS, 8.4% in MINT; P < .01). CONCLUSIONS: Telephone-based preclinical patient navigation has the potential to be effective for older Black men. Our results indicate the importance of community-based health interventions for improving health among minority men. (Am J Public Health. Published online ahead of print July 20, 2017: e1-e8. doi:10.2105/AJPH.2017.303885).
PMCID:5551599
PMID: 28727540
ISSN: 1541-0048
CID: 2640252