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Rounding up the usual suspects: confirmation bias in epidemiological research

Braithwaite, R Scott; Ban, Kaoon Francois; Stevens, Elizabeth R; Caniglia, Ellen C
PMID: 33928375
ISSN: 1464-3685
CID: 4873822

When does nonadherence indicate a deviation from patient-centered care?

Langford, Aisha T; Kang, Stella K; Braithwaite, R Scott
Patient-centered care, defined as "providing care that is respectful of, and responsive to, individual patient preferences, needs and values, and ensuring that patient values guide all clinical decisions," is advocated by clinicians and professional organizations and is part of a composite criterion for augmented reimbursement for various health care settings, including patient-centered medical homes. Despite general agreement that patient-centered care is a good idea and worthy of incentivization, patient-centered care is difficult to assess accurately, scalably, and feasibly. In this commentary, we suggest that assessment of patient-centered care may be improved by identifying circumstances that indicate its probable absence-in particular, by flagging probable discordance between a patient's preferences and their treatment care plan. One potential marker of this discordance is persistent lack of control of a comorbid condition that is easily controllable by existing therapies and where existing therapies are sufficiently diverse to be compatible with a wide range of patient preferences (eg, stage 1 hypertension, type 2 diabetes with glycated hemoglobin < 8.5%). We outline how this approach may be tested, validated, and harmonized with existing quality improvement activities.
PMID: 34002964
ISSN: 1936-2692
CID: 4876932

Project ACTIVE: a Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care in an Urban Safety-Net Setting

Applegate, Melanie; Scott, Ebony; Taksler, Glen B; Sanchez, Mirtala; Duong, Nguyet; Mark, Laurie; Caniglia, Ellen; Wallach, Andrew; Braithwaite, R Scott
BACKGROUND:Evidence-based preventive care in the USA is underutilized, diminishing population health and worsening health disparities. We developed Project ACTIVE, a program to improve adherence with preventive care goals through personalized and patient-centered care. OBJECTIVE:To determine whether Project ACTIVE improved utilization of preventive care and/or estimated life expectancy compared to usual care. DESIGN/METHODS:Single-site randomized controlled trial. PARTICIPANTS/METHODS:Cluster-randomized 140 English or Spanish speaking adult patients in primary care with at least one of twelve unfulfilled preventive care goals based on USPSTF grade A and B recommendations. INTERVENTION/METHODS:Project ACTIVE employs a validated mathematical model to predict and rank individualized estimates of health benefit that would arise from improved adherence to different preventive care guidelines. Clinical staff engaged the participant in a shared medical decision-making (SMD) process to identify highest priority unfulfilled clinical goals, and health coaching staff engaged the participant to develop and monitor action steps to reach those goals. MAIN MEASURES/METHODS:Change in number of unfulfilled preventive care goals from USPSTF grade A and B recommendations and change in overall gain in estimated life expectancy. KEY RESULTS/RESULTS:In an intent-to-treat analysis, Project ACTIVE increased the average number of fulfilled preventive care goals out of 12 by 0.68 in the intervention arm compared with 0.15 in the control arm (mean difference [95% CI] 0.53 [0.19-0.86]), yielding a gain in estimated life expectancy of 8.8 months (3.8, 14.2). In a per-protocol analysis, Project ACTIVE increased fulfilled preventive care goals by 0.80 in the intervention arm compared with 0.16 in the control arm (mean difference [95% CI], 0.65 [0.25-1.04]), yielding a gain in estimated life expectancy of 13.7 months (6.2, 21.2). Among the 12 preventive care goals, more improvement occurred for alcohol use, hypertension, hyperlipidemia, depression, and smoking. CONCLUSIONS:Project ACTIVE improved unfulfilled preventive care goals and improved estimated life expectancy. CLINICAL TRIAL REGISTRATION NUMBER/BACKGROUND:NCT04211883.
PMID: 33443695
ISSN: 1525-1497
CID: 4747142

Are Discount Rates Too High? Population Health and Intergenerational Equity

Braithwaite, R Scott; Roberts, Mark S
Increasing attention is being paid to policy decisions in which shorter-term benefits may be eclipsed by longer-term harms, such as environmental damage. Health policy decisions have largely been spared this scrutiny, even though they too may contribute to longer-term harms. Any healthy population or society must sustain itself through reproduction, and therefore, transgenerational outcomes should be of intrinsic importance from a societal perspective. Yet, the discount rates typically employed in cost-effectiveness analyses have the effect of minimizing the importance of transgenerational health outcomes. We argue that, because cost-effectiveness analysis is based on foundational axioms of decision theory, it should value transgenerational outcomes consistently with those axioms, which require discount rates substantially lower than 3%. We discuss why such lower rates may not violate the Cretin-Keeler paradox.
PMID: 33435827
ISSN: 1552-681x
CID: 4771452

Which Health Systems Provide the Most Health?

Braithwaite, R Scott
PMID: 31913754
ISSN: 1942-7905
CID: 4257422

Does Reducing Drinking in Patients with Unhealthy Alcohol Use Improve Pain Interference, Use of Other Substances, and Psychiatric Symptoms?

Caniglia, Ellen C; Stevens, Elizabeth R; Khan, Maria; Young, Kailyn E; Ban, Kaoon; Marshall, Brandon D L; Chichetto, Natalie E; Gaither, Julie R; Crystal, Stephen; Edelman, Eva Jennifer; Fiellin, David A; Gordon, Adam J; Bryant, Kendall J; Tate, Janet; Justice, Amy C; Braithwaite, Ronald Scott
BACKGROUND:We aimed to investigate the impact of reducing drinking in patients with unhealthy alcohol use on improvement of chronic pain interference, substance use, and psychiatric symptoms. METHODS:We analyzed longitudinal data from 2003 to 2015 in the Veterans Aging Cohort Study, a prospective, multisite observational study of US veterans, by emulating a hypothetical randomized trial (a target trial). Alcohol use was assessed using the AUDIT questionnaire, and outcome conditions were assessed via validated survey items. Individuals were followed from the first time their AUDIT score was ≥ 8 (baseline), a threshold consistent with unhealthy alcohol use. We compared individuals who reduced drinking (AUDIT < 8) at the next follow-up visit with individuals who did not (AUDIT ≥ 8). We fit separate logistic regression models to estimate odds ratios for improvement of each condition 2 years postbaseline among individuals who had that condition at baseline: moderate or severe pain interference symptoms, tobacco smoking, cannabis use, cocaine use, depressive symptoms, and anxiety symptoms. Inverse probability weighting was used to account for potential selection bias and confounding. RESULTS:Adjusted 2-year odds ratios (95% confidence intervals) for associations between reducing drinking and improvement or resolution of each condition were as follows: 1.49 (0.91, 2.42) for pain interference symptoms, 1.57 (0.93, 2.63) for tobacco smoking, 1.65 (0.92, 2.95) for cannabis use, 1.83 (1.03, 3.27) for cocaine use, 1.11 (0.64, 1.92) for depressive symptoms, and 1.33 (0.80, 2.22) for anxiety symptoms. CONCLUSIONS:We found some evidence for improvement of pain interference symptoms and substance use after reducing drinking among US veterans with unhealthy alcohol use, but confidence intervals were wide.
PMID: 33030753
ISSN: 1530-0277
CID: 4627062

Cost-effectiveness of direct anti-viral agents for hepatitis C virus infection and a combined intervention of syringe access and medication assisted therapy for opioid use disorders in an injection drug use population

Stevens, Elizabeth R; Nucifora, Kimberly A; Hagan, Holly; Jordan, Ashly E; Uyei, Jennifer; Khan, Bilal; Dombrowski, Kirk; des Jarlais, Don; Braithwaite, R Scott
BACKGROUND:There are too many plausible permutations and scale-up scenarios of combination hepatitis C (HCV) interventions for exhaustive testing in experimental trials. Therefore, we used computer simulation to project the health and economic impact of alternative combination intervention scenarios for people who inject drugs (PWID), focusing on direct anti-viral agents (DAA) and medication-assisted treatment combined with syringe access programs (MAT+). METHODS:We performed an allocative efficiency study using a mathematical model simulating the progression of HCV in PWID and its related consequences. Two previously validated simulations were combined to estimate the cost-effectiveness of intervention strategies that included a range of coverage levels. Analyses were performed from a health sector and societal perspective with a 15-year time horizon and a discount rate of 3%. RESULTS:From a health-sector perspective (excluding criminal justice system-related costs), four potential strategies fell on the cost-efficiency frontier. DAA at 20% coverage had an ICER of $27,251/QALY. Combinations of DAA 20% with MAT+ at 20%, 40%, and 80% coverage had ICERs of $165,985/QALY, $325,860/QALY, and $399,189/QALY, respectively. When analyzed from a societal perspective (including criminal justice system-related costs), DAA 20% with MAT+ 80% was most effective and was cost saving. While DAA 20% with MAT+ 80% was more expensive (e.g., less cost-saving) than MAT+ 80% alone without DAA, it offered favorable value compared to MAT+ 80% alone ($23,932/QALY). CONCLUSION/CONCLUSIONS:When considering health sector costs alone, DAA alone was the most cost-effective intervention. However, with criminal justice system-related costs, DAA and MAT+ implemented together become the most cost-effective interventions.
PMID: 31400755
ISSN: 1537-6591
CID: 4034552

Impact along the HIV pre-exposure prophylaxis "cascade of prevention" in western Kenya: a mathematical modelling study

Bershteyn, Anna; Sharma, Monisha; Akullian, Adam N; Peebles, Kathryn; Sarkar, Supriya; Braithwaite, R Scott; Mudimu, Edinah
INTRODUCTION/BACKGROUND:Over one hundred implementation studies of HIV pre-exposure prophylaxis (PrEP) are completed, underway or planned. We synthesized evidence from these studies to inform mathematical modelling of the prevention cascade for oral and long-acting PrEP in the setting of western Kenya, one of the world's most heavily HIV-affected regions. METHODS:We incorporated steps of the PrEP prevention cascade - uptake, adherence, retention and re-engagement after discontinuation - into EMOD-HIV, an open-source transmission model calibrated to the demography and HIV epidemic patterns of western Kenya. Early PrEP implementation research from East Africa was used to parameterize prevention cascades for oral PrEP as currently implemented, delivery innovations for oral PrEP, and future long-acting PrEP. We compared infections averted by PrEP at the population level for different cascade assumptions and sub-populations on PrEP. Analyses were conducted over the 2020 to 2040 time horizon, with additional sensitivity analyses for the time horizon of analysis and the time when long-acting PrEP becomes available. RESULTS:The maximum impact of oral PrEP diminished by over 98% across all prevention cascades, with the exception of long-acting PrEP under optimistic assumptions about uptake and re-engagement after discontinuation. Long-acting PrEP had the highest population-level impact, even after accounting for possible delays in product availability, primarily because its effectiveness does not depend on drug adherence. Retention was the most significant cascade step reducing the potential impact of long-acting PrEP. These results were robust to assumptions about the sub-populations receiving PrEP, but were highly influenced by assumptions about re-initiation of PrEP after discontinuation, about which evidence was sparse. CONCLUSIONS:Implementation challenges along the prevention cascade compound to diminish the population-level impact of oral PrEP. Long-acting PrEP is expected to be less impacted by user uptake and adherence, but it is instead dependent on product availability in the short term and retention in the long term. To maximize the impact of long-acting PrEP, ensuring timely product approval and rollout is critical. Research is needed on strategies to improve retention and patterns of PrEP re-initiation.
PMCID:7325506
PMID: 32602669
ISSN: 1758-2652
CID: 4504042

EBM's Six Dangerous Words

Braithwaite, R Scott
PMID: 32369132
ISSN: 1538-3598
CID: 4439132

Insights Provided by Depression Screening Regarding Pain, Anxiety, and Substance use in a Veteran Population

Stevens, Elizabeth R; Mazumdar, Medha; Caniglia, Ellen C; Khan, Maria R; Young, Kailyn E; Edelman, E Jennifer; Gordon, Adam J; Fiellin, David A; Maisto, Stephen A; Chichetto, Natalie E; Crystal, Stephan; Gaither, Julie R; Justice, Amy C; Braithwaite, R Scott
OBJECTIVE/UNASSIGNED:We sought to quantify the extent to which a depression screening instrument commonly used in primary care settings provides additional information regarding pain interference symptoms, anxiety, and substance use. METHODS/UNASSIGNED:Veterans Aging Cohort Study (VACS) data collected from 2003 through 2015 was used to calculate odds ratios (OR) for associations between positive depression screening result cutoffs and clustering conditions. We assessed the test performance characteristics (likelihood ratio value, positive predictive value, and the percentage of individuals correctly classified) of a positive Patient Health Questionnaire (PHQ-9 & PHQ-2) depression screen for the identification of pain interference symptoms, anxiety, and substance use. RESULTS/UNASSIGNED:A total 7731 participants were included in the analyses. The median age was 50 years. The PHQ-9 threshold of ≥20 was strongly associated with pain interference symptoms (OR 21.6, 95% CI 17.5-26.7) and anxiety (OR 72.1, 95% CI 52.8-99.0) and yielded likelihood ratio values of 7.5 for pain interference symptoms and 21.8 for anxiety and positive predictive values (PPV) of 84% and 95%, respectively. A PHQ-9 score of ≥10 still showed significant associations with pain interference symptoms (OR 6.1, 95% CI 5.4-6.9) and symptoms of anxiety (OR 11.3, 95% CI 9.7-13.1) and yet yielded lower likelihood ratio values (4.36 & 8.24, respectively). The PHQ-9 was less strongly associated with various forms of substance use. CONCLUSION/UNASSIGNED:Depression screening provides substantial additional information regarding the likelihood of pain interference symptoms and anxiety and should trigger diagnostic assessments for these other conditions.
PMCID:7418233
PMID: 32772883
ISSN: 2150-1327
CID: 4576332