US Healthcare Settings Research Articles

Cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) in chronic and treatment-resistant post-traumatic stress disorder of moderate or higher severity: A health-economic model.

To explore the cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) compared to placebo with therapy (PT) in US healthcare settings. A health state-transition model was used to analyze the cost-effectiveness of MDMA-AT for treating patients with chronic PTSD of moderate or higher severity. Both treatment arms consisted of 3 preparation (90-min), 3 interventional (8-h), and 9 integration (90-min) sessions, lasting ~4 months total. All sessions included psychotherapy, with interventional also including MDMA or placebo. After receiving treatment, patients were distributed across health states of No PTSD (not meeting PTSD diagnostic criteria), Non-Severe PTSD (treatment responders), Severe PTSD (treatment non-responders), and death. Each state had unique healthcare costs and utilities sourced from real-world data analysis and patient data from MDMA-AT clinical trials (including long-term follow-up). The base-case analysis considered the payer's perspective with a 5-year horizon, 3.5% annual cost and effect discounts, and an assumed MDMA medication price of $12,000 per session. Trial-derived utilities and US life tables mortality data were used to calculate quality-adjusted life years (QALY). The main outcome was an incremental cost-effectiveness ratio (ICER) with a $150,000 willingness-to-pay (WTP) threshold. The base-case ICER was $83,845 per QALY. Total direct costs were $64,745 in the MDMA-AT and $33,132 in the PT arms ($31,613 increment). The costs of intervention were $48,376 for MDMA-AT and $12,376 for PT. The highest MDMA medication cost to fit under the WTP threshold was $20,314 per session. Costs related to PTSD healthcare visits and other PTSD treatments were lower with MDMA-AT than PT (-$2,511 and -$1,877 increments, respectively). Utility benefits were higher in MDMA-AT than PT, with 3.691 and 3.314 QALYs generated over 5 years, respectively (0.377 QALY increment). These data suggest MDMA-AT may be a cost-effective treatment compared to PT for patients with chronic PTSD of moderate or higher severity.

Characterizing Long COVID in Children and Adolescents

Most research to understand postacute sequelae of SARS-CoV-2 infection (PASC), or long COVID, has focused on adults, with less known about this complex condition in children. Research is needed to characterize pediatric PASC to enable studies of underlying mechanisms that will guide future treatment. To identify the most common prolonged symptoms experienced by children (aged 6 to 17 years) after SARS-CoV-2 infection, how these symptoms differ by age (school-age [6-11 years] vs adolescents [12-17 years]), how they cluster into distinct phenotypes, and what symptoms in combination could be used as an empirically derived index to assist researchers to study the likely presence of PASC. Multicenter longitudinal observational cohort study with participants recruited from more than 60 US health care and community settings between March 2022 and December 2023, including school-age children and adolescents with and without SARS-CoV-2 infection history. SARS-CoV-2 infection. PASC and 89 prolonged symptoms across 9 symptom domains. A total of 898 school-age children (751 with previous SARS-CoV-2 infection [referred to as infected] and 147 without [referred to as uninfected]; mean age, 8.6 years; 49% female; 11% were Black or African American, 34% were Hispanic, Latino, or Spanish, and 60% were White) and 4469 adolescents (3109 infected and 1360 uninfected; mean age, 14.8 years; 48% female; 13% were Black or African American, 21% were Hispanic, Latino, or Spanish, and 73% were White) were included. Median time between first infection and symptom survey was 506 days for school-age children and 556 days for adolescents. In models adjusted for sex and race and ethnicity, 14 symptoms in both school-age children and adolescents were more common in those with SARS-CoV-2 infection history compared with those without infection history, with 4 additional symptoms in school-age children only and 3 in adolescents only. These symptoms affected almost every organ system. Combinations of symptoms most associated with infection history were identified to form a PASC research index for each age group; these indices correlated with poorer overall health and quality of life. The index emphasizes neurocognitive, pain, and gastrointestinal symptoms in school-age children but change or loss in smell or taste, pain, and fatigue/malaise-related symptoms in adolescents. Clustering analyses identified 4 PASC symptom phenotypes in school-age children and 3 in adolescents. This study developed research indices for characterizing PASC in children and adolescents. Symptom patterns were similar but distinguishable between the 2 groups, highlighting the importance of characterizing PASC separately for these age ranges.

Factors Associated with Poor Clinical and Microbiologic Outcomes in C. auris Bloodstream Infection: A Multicenter Retrospective Cohort Study.

C. auris has become a growing concern worldwide due to increases in incidence of colonization and reports of invasive infections. There are limited data on clinical factors associated with poor outcomes in patients with C. auris bloodstream infection (BSI). We assembled a multicenter retrospective cohort of patients with C. auris BSI from two geographics areas in US healthcare settings. We collected data on demographic, clinical, and microbiologic characteristics to describe the cohort and constructed multivariate logistic regression models to understand risk factors for two clinical outcomes, all-cause mortality during facility admission, and blood culture clearance. Our cohort consisted of 187 patients with C. auris BSI (56.1% male, 55.6% age >65 years); 54.6% died by facility discharge and 66.9% (of 142 with available data) experienced blood culture clearance. Pitt bacteremia score at infection onset was associated with mortality (odds-ratio [95% confidence interval]: 1.19 [1.01,1.40] per 1-point increase). Hemodialysis was associated with a reduced odds of microbiologic clearance (0.15 [0.05,0.43]) and with mortality (3.08 [1.27,7.50]). The Pitt bacteremia score at the onset of C. auris BSI may be a useful tool in identifying patients at risk for mortality. Targeted infection prevention practices in patients receiving hemodialysis may be useful to limit poor outcomes.

Adapting and testing measures of organizational context in primary care clinics in KwaZulu-Natal, South Africa

BackgroundImplementation science frameworks situate intervention implementation and sustainment within the context of the implementing organization and system. Aspects of organizational context such as leadership have been defined and measured largely within US health care settings characterized by decentralization and individual autonomy. The relevance of these constructs in other settings may be limited by differences like collectivist orientation, resource constraints, and hierarchical power structures. We aimed to adapt measures of organizational context in South African primary care clinics.MethodsWe convened a panel of South African experts in social science and HIV care delivery and presented implementation domains informed by existing frameworks and prior work in South Africa. Based on panel input, we selected contextual domains and adapted candidate items. We conducted cognitive interviews with 25 providers in KwaZulu-Natal Province to refine measures. We then conducted a cross-sectional survey of 16 clinics with 5–20 providers per clinic (N = 186). We assessed reliability using Cronbach’s alpha and calculated interrater agreement (awg) and intraclass correlation coefficient (ICC) at the clinic level. Within clinics with moderate agreement, we calculated correlation of clinic-level measures with each other and with hypothesized predictors – staff continuity and infrastructure – and a clinical outcome, patient retention on antiretroviral therapy.ResultsPanelists emphasized contextual factors; we therefore focused on elements of clinic leadership, stress, cohesion, and collective problem solving (critical consciousness). Cognitive interviews confirmed salience of the domains and improved item clarity. After excluding items related to leaders’ coordination abilities due to missingness and low agreement, all other scales demonstrated individual-level reliability and at least moderate interrater agreement in most facilities. ICC was low for most leadership measures and moderate for others. Measures tended to correlate within facility, and higher stress was significantly correlated with lower staff continuity. Organizational context was generally more positively rated in facilities that showed consistent agreement.ConclusionsAs theorized, organizational context is important in understanding program implementation within the South African health system. Most adapted measures show good reliability at individual and clinic levels. Additional revision of existing frameworks to suit this context and further testing in high and low performing clinics is warranted.

Assessing Management of Abnormal Cervical Cancer Screening Results and Concordance with Guideline Recommendations in Three US Healthcare Settings.

Follow-up of abnormal results is essential to cervical cancer screening, but data on adherence to follow-up are limited. We describe patterns of follow-up after screening abnormalities and identify predictors of guideline-concordant follow-up. We identified the index screening abnormality (positive human papillomavirus test or atypical squamous cells of undetermined significance or more severe cytology) among women of ages 25 to 65 years at three US healthcare systems during 2010 to 2019. We estimated the cumulative incidence of surveillance testing, colposcopy, or treatment after the index abnormality and initial colposcopy. Logistic regressions were fit to identify predictors of guideline-concordant follow-up according to contemporaneous guidelines. Among 43,007 patients with an index abnormality, the cumulative incidence of any follow-up was 49.6% by 4 years for those with atypical squamous cells of undetermined significance/human papillomavirus-negative and higher for abnormalities warranting immediate colposcopy. The 1-year cumulative incidence of any follow-up after colposcopy was 70% for patients with normal results or cervical intraepithelial neoplasia I and 90% for patients with cervical intraepithelial neoplasia II+. Rates of concordant follow-up after screening and colposcopy were 52% and 47%, respectively. Discordant follow-up was associated with factors including age, race/ethnicity, overweight/obese body mass index, and specific types of public payor coverage or being uninsured. Adherence to the recommended follow-up of cytologic and histopathologic abnormalities is inconsistent in clinical practice. Concordance was poor for mild abnormalities and improved, although suboptimal, for more severe abnormalities. There remain gaps in the cervical cancer screening process in clinical practice. Further study is needed to understand the barriers to the appropriate management of cervical abnormalities.

Statins exposure and acute pancreatitis: a retrospective cohort study using a large national insurance database

ObjectivesThe association between the use of statins and the incidence of acute pancreatitis (AP) has yielded inconsistent findings. While statins have been implicated as an aetiology for drug-induced pancreatitis, more...

Assessing Implementation of Social Screening Within US Health Care Settings: A Systematic Scoping Review.

Though a growing crop of health care reforms aims to encourage health care-based social screening, no literature has synthesized existing social screening implementation research to inform screening practice and policymaking. Systematic scoping review of peer-reviewed literature on social screening implementation published 1/1/2011-2/17/2022. We applied a 2-concept search (health care-based screening; social risk factors) to PubMed and Embase. Studies had to explore the implementation of health care-based multi-domain social screening and describe 1+ outcome related to the reach, adoption, implementation, and/or maintenance of screening. Two reviewers extracted data related to key study elements, including sample, setting, and implementation outcomes. Forty-two articles met inclusion criteria. Reach (n = 7): We found differences in screening rates by patient race/ethnicity; findings varied across studies. Patients who preferred Spanish had lower screening rates than English-preferring patients. Adoption (n = 13): Workforce education and dedicated quality improvement projects increased screening adoption. Implementation (n = 32): Time was the most cited barrier to screening; administration time differed by tool/workforce/modality. Use of standardized screening tools/workflows improved screening integration. Use of community health workers and/or technology improved risk disclosure and facilitated screening in resource-limited settings. Maintenance (n = 1): Only 1 study reported on maintenance; results showed a drop in screening over 21 months. Critical evidence gaps in social screening implementation persist. These include gaps in knowledge about effective strategies for integrating social screening into clinical workflows and ways to maximize screening equity. Future research should leverage the rapidly increasing number of screening initiatives to elevate and scale best practices.

Factors influencing the transition of foreign-educated nurses to the US healthcare setting: A systematic review.

This literature review examined the impact of the orientation or onboarding programs on the transition of foreign-educated nurses to a US healthcare setting and factors influencing their transition. Recruitment of foreign-educated nurses has been a solution to the ongoing nursing workforce shortage in the United States. However, they face various challenges in their transition to employment in the United States. Adequate orientation and continued support are needed for the successful transition of foreign-educated nurses. A systematic literature search was conducted in 2022 across PubMed, CINAHL, Academic Search Complete, Google Scholar, and MEDLINE databases. This review selected only articles published between 2015 and 2022 in English that addressed foreign-educated nurses' transition issues in US healthcare settings. The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The quality of the articles was appraised using the John Hopkins Evidence-based Practice tool. This review of 14 articles revealed that the quality of orientation and organizational support were positively associated with foreign-educated nurses' job satisfaction and turnover. Factors influencing foreign-educated nurses' transition included peer support, job assignment and workload, credentialing, communication and cultural adjustment, psychological factors, safety perceptions, work environment, and coping strategies. There was a lack of literature that evaluated orientation or onboarding programs for foreign-educated nurses. Further research is needed to explore the effectiveness of supportive programs in promoting their smooth transition. Efficient onboarding or orientation programs and policies for foreign-educated nurses are crucial, considering the factors influencing their transition. Good programs and policies that prioritize the support, integration, and professional development of FENs will help maximize their contributions to health care.

Stakeholder perspectives on social screening in US healthcare settings

BackgroundEvidence on the health impacts of social conditions has led US healthcare systems to consider identifying and addressing social adversity—e.g. food, housing, and transportation insecurity—in care delivery settings. Social screening is one strategy being used to gather patient information about social circumstances at the point of care. While several recent studies describe the rapid proliferation of social screening activities, little work has explored either why or how to implement social screening in clinical settings. Our study objectives were to assess diverse healthcare stakeholder perspectives on both the rationale for social screening and evidence needed to inform practice and policy-relevant implementation decisions.MethodsWe convened five focus groups with US experts representing different stakeholder groups: patient advocates, community-based organizations, healthcare professionals, payers, and policymakers. In total, 39 experts participated in approximately 90-minute long focus groups conducted between January-March 2021. A inductive thematic analysis approach was used to analyze discussions.ResultsThree themes emerged from focus groups, each reflecting the tension between the national enthusiasm for screening and existing evidence on the effectiveness and implementation of screening in clinical settings: (1) ambiguity about the rationale for social screening; (2) concerns about the relavence of screening tools and approaches, particularly for historically marginalized populations; (3) lack of clarity around the resources needed for implementation and scaling.ConclusionWhile participants across groups described potential benefits of social screening, they also highlighted knowledge gaps that interfered with realizing these benefits. Efforts to minimize and ideally resolve these knowledge gaps will advance future social screening practice and policy.

Cost-effectiveness of an insertable cardiac monitor in a high-risk population in the US

BackgroundInsertable cardiac monitors (ICMs) are a clinically effective means of detecting atrial fibrillation (AF) in high-risk patients, and guiding the initiation of non-vitamin K oral anticoagulants (NOACs). Their cost-effectiveness from a US clinical payer perspective is not yet known. The objective of this study was to evaluate the cost-effectiveness of ICMs compared to standard of care (SoC) for detecting AF in patients at high risk of stroke (CHADS2 ≥ 2), in the US.MethodsUsing patient data from the REVEAL AF trial (n = 393, average CHADS2 score = 2.9), a Markov model estimated the lifetime costs and benefits of detecting AF with an ICM or with SoC (specifically intermittent use of electrocardiograms and 24-h Holter monitors). Ischemic and hemorrhagic strokes, intra- and extra-cranial hemorrhages, and minor bleeds were modelled. Diagnostic and device costs, costs of treating stroke and bleeding events and medical therapy—specifically costs of NOACs were included. Costs and health outcomes, measured as quality-adjusted life years (QALYs), were discounted at 3% per annum, in line with standard practice in the US setting. One-way deterministic and probabilistic sensitivity analyses (PSA) were undertaken.ResultsLifetime per-patient cost for ICM was $31,116 versus $25,330 for SoC. ICMs generated a total of 7.75 QALYs versus 7.59 for SoC, with 34 fewer strokes projected per 1000 patients. The model estimates a number needed to treat of 29 per stroke avoided. The incremental cost-effectiveness ratio was $35,528 per QALY gained. ICMs were cost-effective in 75% of PSA simulations, using a $50,000 per QALY threshold, and a 100% probability of being cost-effective at a WTP threshold of $150,000 per QALY.ConclusionsThe use of ICMs to identify AF in a high-risk population is likely to be cost-effective in the US healthcare setting.

1192. Containment of Sustained Transmission of Drug-resistant Acinetobacter baumannii by Pulsed-Xenon Ultraviolet Disinfection of the Patient Room in the Intensive Care Unit

Abstract Background No-touch environmental disinfection has been highlighted in the last decade to control transmission of multidrug-resistant Gram-positive organisms including MRSA and VRE, but its effectiveness to control gram-negative bacteria has not been well examined. Also, its effectiveness outside the US healthcare setting is seldom reported. Methods This study was conducted in the intensive care unit (ICU) of Yamagata University Hospital, a 637-bed tertiary referral hospital. Sporadic acquisition of two drug-resistant Acinetobacter baumannii (2DRA) began in late 2013. Despite various infection control practices including hand hygiene promotion and intensified manual terminal cleaning, transmission of this pathogen continued. In February 2018, pulsed-xenon ultraviolet (PX-UV) disinfection was added. The study periods were defined as follows: the baseline period (August 2016 to January 2018, intensified manual cleaning) and the intervention period (February 2018 to December 2021, addition of PX-UV). Throughout the study periods, all patients were regularly screened for 2DRA to detect acquisition of those pathogens in the ICU. Results The incidence of newly acquired 2DRA significantly declined over time (4.45 per 1,000 patient days in the baseline period to 1.20 in the intervention period, relative risk (RR): 0.27, 95% confidence interval: 0.12-0.61). Notably, horizontal transmission of 2DRA was completely contained, not only in the ICU but also throughout the hospital (Figure). Newly acquired 2DRA events (all wards, monthly) Conclusion Adding PX-UV after through manual terminal cleaning is effective in controlling acquisition of 2DRA in the ICU patients and led to termination of transmission of 2DRA in our hospital. The effectiveness of PX-UV in controlling gram-negative MDROs in the non-US healthcare settings is suggested. Disclosures All Authors: No reported disclosures.

1288. US Healthcare Provider Perspectives on the initiation of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world study (BEYOND)

Abstract Background CAB+RPV LA is a complete regimen for treatment of virologically suppressed people with HIV (PWH). As an injectable therapeutic administered by a healthcare provider (HCP), CAB+RPV LA may alleviate challenges with adherence to daily oral therapy and reduce fear of HIV status disclosure with oral treatment. Real world perspectives from HCPs and PWH are needed to enable successful delivery of this treatment in US healthcare settings. Methods BEYOND is a 2 year prospective, observational, real-world study of utilization, outcomes, and experience of PWH initiating CAB+RPV LA across 30 US sites. HCPs at participating sites (treaters, injectors, drug acquisition/reimbursement staff) completed surveys at site activation (Sep 2021-Feb 2022; with follow-up surveys planned at 6, 12, 24 months) evaluating experiences to date with implementation of CAB+RPV LA at their sites. Results HCPs from 24 sites responded to the initial survey (Table 1). 75% of HCPs estimated that ≥25% of their PWH are eligible for CAB+RPV LA, and 71% of sites are proactively discussing the regimen with ≥25% of PWH. The majority (79%) of treaters reported they were extremely/very positive about administering CAB+RPV LA. Over 90% of injectors reported a positive overall opinion about administering CAB+RPV LA, and 86% reported the injections were easy to administer. Most (87%) HCPs reported injection visits taking ≤45 minutes, including waiting time. Over 95% of sites have patient reminder systems; 86% will manually identify missed injections and all reported manual follow up by site staff. All sites utilizing the injection education video on the external HCP website (n=15/15) found it helpful and 94% (n=16/17) utilizing reimbursement specialists found them to be helpful. In their experience to date, most clinics reported only needing to increase coordination with the pharmacy team and add injection training to implement CAB+RPV LA. The most frequently reported benefits of implementing CAB+RPV LA by HCPs included assurance of patient adherence and patient engagement in their HIV treatment (Table 2). Conclusion Early real-world data from US HCPs in this study indicates interest in and anticipated uptake of CAB+RPV LA at their sites, positive overall opinion, and multiple benefits of administering the CAB+RPV LA regimen to PWH. Disclosures Ricky K. Hsu, MD, Gilead: Honoraria|Merck: Honoraria|ViiV: Advisor/Consultant|ViiV: Grant/Research Support|ViiV: Honoraria John Phoenix, MSN, APRN, FNP-C, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Honoraria|Gilead Sciences: speaker bureau, research funding|Janssen Pharmaceutical: Advisor/Consultant|Janssen Pharmaceutical: Honoraria|Lupin Pharmaceuticals: Advisor/Consultant|Lupin Pharmaceuticals: Honoraria|Napo pharmaceutical: Honoraria|Napo pharmaceutical: speaker bureau|Scinexis: Advisor/Consultant|Scinexis: Honoraria|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Honoraria|ViiV Healthcare: speaker bureau, clinical research funding Gary I. Sinclair, MD, ABBVIE: Grant/Research Support|Gilead: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Janssen: Honoraria|Merck: Grant/Research Support|Thera: Grant/Research Support|Thera: Honoraria|ViiV/GSK: Advisor/Consultant|ViiV/GSK: Grant/Research Support|ViiV/GSK: Honoraria Samir K. Gupta, MD, Gilead Sciences: Advisor/Consultant|GSK/ViiV: Advisor/Consultant|GSK/ViiV: Grant/Research Support Ana Puga, MD, FAAP, AAHIVS, Care Resource: Healthcare provider (HCP)|ViiV Healthcare: Stocks/Bonds Kaitlin Nguyen, PharmD, AAHIVE, ViiV Healthcare: Stocks/Bonds Catherine K. Schubert, PharmD, ViiV Healthcare: Stocks/Bonds Deanna Merrill, PharmD, MBA, AAHIVP, ViiV Healthcare: Salaried employee|ViiV Healthcare: Stocks/Bonds David Richardson, BA, ViiV Healthcare: ViiV provided funding to RTI for the development of the study materials, the conduct of the study, and analysis & interpretation of study results. Kate Nelson, M.Ed, ViIV: ViiV provided funding to RTI for the development of the study materials, the conduct of the study, and analysis & interpretation of study results. Maria Reynolds, MStat, ViiV Healthcare: Viiv provided funding to RTI for the development of the study materials, the conduct of the study, and analysis & interpretation of study results. Laurie Zografos, BS, Viiv: ViiV provided funding to RTI for the development of the study materials, the conduct of the study, and analysis & interpretation of study results. Ashley Jean-Louis, MPH, ViiV Healthcare: (ViiV provided funding to RTI for the development of the study materials, the conduct of the study, and analysis & interpretation of study results.) Cindy Garris, MS, ViiV Healthcare: Employee|ViiV Healthcare: Stocks/Bonds.

Post-Colonoscopy Colorectal Cancer Etiologies in a Large Integrated US Health Care Setting

Post-Colonoscopy Colorectal Cancer Etiologies in a Large Integrated US Health Care Setting

Racial and ethnic disparities in the cervical cancer screening cascade in three U.S. health care settings.

109 Background: There are wide disparities in cervical cancer incidence and mortality in the US by race and ethnicity. Our objective was to characterize racial and ethnic differences in routine cervical cancer screening and follow-up of abnormal findings across three US healthcare settings. Methods: We used 2016 to 2019 data from three sites participating in the METRICS research center, part of the PROSPR II consortium. We evaluated screening among average risk, screen-eligible patients receiving care at participating sites, by race and ethnicity as captured in the EHR. Among patients with a high-risk abnormal finding, we evaluated the proportion receiving colposcopy or biopsy within six months. We conducted multivariate regression to assess the extent to which clinical, socioeconomic, and structural characteristics mediate observed differences in screening. Results: We identified 188,415 eligible patients; 74.6% received cervical cancer screening during the 3-year study window. Screening use was lower among non-Hispanic Black (66.8%) patients and higher among Hispanic (82.5%), Asian/Pacific Islander (75.8%) patients, and those who identified as multi-racial or “other” race (75.8%) compared to non-Hispanic White (71.4%) patients. In multivariate regression, most differences were explained by the distribution of patients across sites, with the lowest screening rate observed at the site caring for the majority of both Black and Hispanic patients. However, Hispanic patients remained more likely to be screened even after controlling for a variety of clinical and sociodemographic factors (Risk Ratio: 1.14 [1.12, 1.16]). Among those receiving a screening test, Black and Hispanic patients were more likely to receive Pap-only testing (vs. HPV DNA co-testing) compared to non-Hispanic White patients and were more likely to have abnormal findings. Follow-up from abnormal results within six months was low for all groups (68.7%) but highest among Hispanic participants (77.7%). Conclusions: In a large cohort of patients receiving care in three community settings, cervical cancer screening and follow-up were lower than national targets. Lower screening for Black women is strongly driven by insurance and site of care, underscoring the value of addressing systemic inequity. More research is needed to characterize the relatively higher screening for Hispanic women, which is not explained by observed individual or systemic factors. Additionally, it is crucial to focus on follow-up after abnormalities are identified, which is low for all populations.

Use of ICD-10 Codes for Human Trafficking: Analysis of Data From a Large, Multisite Clinical Database in the United States.

People experiencing trafficking often seek health care but are not identified. Although the Centers for Disease Control and Prevention added new International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes specific to human trafficking (hereinafter, HT ICD-10-CM codes) that could systematize the identification and documentation of human trafficking in US health care settings, the extent of their use is unknown. The objectives of this study were to investigate (1) the frequency of HT ICD-10-CM code use in US health care organizations (HCOs) and (2) demographic data associated with HT ICD-10-CM codes using a large clinical database. This retrospective study used deidentified data collected from October 1, 2018, through March 30, 2021, from a clinical database (N = 69 740 144 patients) network (TriNetX) of 48 collaborating US HCOs. Data included number of patients with ≥1 HT ICD-10-CM code, diagnoses, and demographic characteristics (age, sex, race, ethnicity, and region). HT ICD-10-CM codes were associated with 298 patients in US HCOs, most of whom were young (mean [SD] age, 26 [16] y), White (53.0%; n = 158), and female (87.9%; n = 262). Thirty-seven of 48 (77.1%) participating HCOs used ≥1 HT ICD-10-CM code. The most frequently used HT ICD-10-CM codes were "forced sexual exploitation, suspected" (32.2%; n = 96) and "personal history of forced labor or sexual exploitation" (27.1%; n = 81). Labor trafficking codes were noted in approximately 3.7% of cases. HT ICD-10-CM codes are being used by health care professionals, as confirmed by large databases. Further research is needed to understand variation in code use and risk factors associated with human trafficking.

Primary care providers' experiences treating low back pain.

Our original work addresses the biological sex impact on low back pain (LBP) management and prognosis in primary care settings. To our knowledge, our study is the first in the United States to evaluate the differences in clinicians' approaches to LBP in the ambulatory setting specifically based on patient gender. Our findings suggest that there is a knowledge gap among primary care providers (PCPs) toward the potential impact of biological sex on LBP and a bias toward gender roles when counseling patients for home chores or occupational tasks. Further evaluation of this knowledge gap and its impact on LBP management and prognosis is recommended in US healthcare settings. This study aims to explore PCP experiences and practice patterns regarding LBP in females compared to males in US healthcare settings. We utilized a cross-sectional study design and convenience sampling. Data were collected anonymously utilizing a 27-item online survey sent periodically via email to PCPs working in Ohio. We had 58 responses for analysis; data were analyzed utilizing bivariate and multivariate analyses. On average, approximately 9 out of 10 responding clinicians reported experiencing LBP. PCPs were not in agreement that LBP is different in women than men. Clinicians with a women's health, osteopathic, or sport's medicine background were more likely to agree that LBP is different in women than in men. PCPs were more likely to counsel female patients about pelvic floor exercises; however, their intake of present pelvic symptoms in LBP female patients is suboptimal. PCPs were more likely to counsel females for home chores than males, which is aligned with the perceived traditional gender roles among PCPs. There may be a knowledge gap among PCPs toward the potential impact of biological sex on LBP and a bias toward gender roles when counseling patients for home chores or occupational tasks. Further investigation of this knowledge gap and counseling approaches is recommended to better bridge the gender disparity.

Home-Based Hematopoietic Cell Transplantation in the United States

Patients undergoing allogeneic (allo) and autologous (auto) hematopoietic cell transplantation (HCT) require extensive hospitalizations or daily clinic visits for the duration of their transplantation. Home HCT, wherein patients live at home and providers make daily trips to the patient's residence to perform assessments and deliver any necessary interventions, may enhance patient quality of life and improve outcomes. We conducted the first study of home HCT in the United States to evaluate this model in the US healthcare setting and to determine the effect on clinical outcomes and quality of life. This case-control study evaluated patients who received home HCT at Duke University in Durham, North Carolina, from November 2012 to March 2018. Each home HCT patient was matched with 2 controls from the same institution who had received standard treatment based on age, disease, and type of transplant for outcomes comparison. Clinical outcomes were abstracted from electronic health records, and quality of life was assessed via Functional Assessment of Cancer Therapy-Bone Marrow Transplant. Clinical outcomes were compared with Student's t-test or Fisher's exact test (continuous variables) or chi-square test (categorical variables). Quality of life scores were compared using the Student t-test. All analyses used a significance threshold of 0.05. Twenty-five patients received home HCT, including 8 allos and 17 autos. Clinical outcomes were not significantly different between the home HCT patients and their matched controls; home HCT patients had decreased incidence of relapse within 1 year of transplantation. Pre-HCT quality of life was well preserved for autologous home HCT patients. This Phase I study demonstrated that home HCT can be successfully implemented in the United States. There was no evidence that home HCT outcomes were inferior to standard-of-care treatment, and patients undergoing autologous home HCT were able to maintain their quality of life. A Phase II randomized trial of home versus standard HCT is currently underway to better compare outcomes and costs.

Colonoscopy Following an Abnormal Fecal Test Result from an Annual Colorectal Cancer Screening Program in a Federally Qualified Health Center.

Individuals with an abnormal fecal immunochemical test (FIT) result have an elevated risk of colorectal cancer, and the risk increases if the follow-up colonoscopy is delayed. Of note, rates of follow-up colonoscopy are alarmingly low in federally qualified health centers (FQHCs), US health care settings that serve a majority racial and ethnic minority patient population. We assessed factors associated with colonoscopy after an abnormal FIT result and used chart-abstracted data to assess reasons (including process measures) for lack of follow-up as part of an annual, mailed-FIT outreach program within a large, Latino-serving FQHC. As part of the National Institutes of Health-funded PROMPT study, we identified patients with an abnormal FIT result and used logistic regression to assess associations between patient demographics and receipt of follow-up colonoscopy, controlling for patients' preferred language. We report on time (days) to referral and time to colonoscopy. For charts with an abnormal FIT result but no evidence of colonoscopy, we performed a manual abstraction and obtained the reason for the absence of colonoscopy. When there was no evidence of colonoscopy in a patient's electronic health record (EHR), we performed an automated query of the administrative claims database to identify colonoscopy outcomes. We identified 324 patients with abnormal FIT results from July to October 2018. These patients were mostly publicly insured (Medicaid 53.1%, Medicare 14.5%), 81.8% were aged 50 to 64 years, 55.3% were female, 80.3% were Hispanic/Latino, and 67.3% preferred to speak Spanish. We found that 108/324 (33.3%) patients completed colonoscopy within 12 months, and the median time to colonoscopy was 94 days (IQR: 68-176). Common barriers to colonoscopy completion, obtained from chart-abstracted data, were: no documentation following referral to gastrointestinal (GI) specialist or GI consultation (41.6%), no referral to GI specialist following abnormal fecal test (34.2%), and absence of a valid insurance authorization (6.5%). Multi-level strategies are needed to provide optimal care across the cancer continuum for FQHC patients. In order to reduce the risk of CRC and realize the return on fecal testing investment, concerted system-level efforts are urgently needed to improve rates of follow-up colonoscopy among FQHC patients and redress racial and ethnic disparities in CRC screening outcomes.

Cost-effectiveness and budget impact of dolutegravir/lamivudine for treatment of human immunodeficiency virus (HIV-1) infection in the United States.

BACKGROUND: Dolutegravir(DTG)/lamivudine(3TC) is the first 2-drug regimen recommended as an initial treatment for people living with HIV (PLHIV). OBJECTIVE: To assess the cost-effectiveness and potential budget impact of DTG/3TC in the US healthcare setting. METHODS: A previously published hybrid decision-tree and Markov cohort state transition model was adapted to estimate the incremental costs and health outcome benefits over a patients' lifetime. DTG/3TC was compared with current standard of care in treatment naive and treatment experienced virologically suppressed PLHIV. Health states included in the model were based upon virologic response and CD4 cell count, with death as an absorbing state. Clinical data was informed by the Phase III GEMINI 1 and 2 clinical trials, a published network meta-analysis (NMA) in treatment-naive patients and the Phase III TANGO clinical trial in treatment experienced patients. Costs and utilities were informed by published data and discounted annually at a rate of 3%. A separate 5-year budget impact analysis was conducted assuming 5%-15% uptake in eligible treatment naive and 10%-30% uptake in eligible treatment experienced patients. RESULTS: In the treatment naive analyses based on GEMINI 1 and 2, DTG/3TC dominated, i.e., was less costly and more effective, than all comparators. DTG/3TC resulted in 0.083 incremental quality-adjusted life-years (QALYs) at a cost saving of $199,166 compared with the DTG + tenofovir disoproxil(TDF)/emtricitabine(FTC) comparator arm. The incremental QALY and cost savings for DTG/3TC compared with DTG/abacavir(ABC)/3TC, cobicistat-boosted darunavir(DRV/c)/tenofovir alafenamide(TAF)/FTC, and bictegravir (BIC)/TAF/FTC, based on NMA results were 0.465, 0.142, and 0.698, and $42,948, $122,846, and $44,962, respectively. In the analyses of treatment-experienced virologically suppressed patients based on TANGO, DTG/3TC offered slightly lower QALYs (-0.037) with an estimated savings of $78,730 when compared with continuation of TAF-based regimen (TBR). Sensitivity analyses demonstrated that these conclusions were relatively insensitive to alternative parameter estimates. The budget impact analysis estimated that by 5th year a total of 70,240 treatment naive patients and 1,340,480 treatment experienced patients could be eligible to be prescribed DTG/3TC. The estimated budget savings over 5 years ranged from $1.12b to $3.35b (corresponding to 27,512 to 82,536 on DTG/3TC by year 5) in the lowest and highest uptake scenarios, respectively. CONCLUSION: In conclusion, DTG/3TC with its comparable efficacy and lower drug acquisition costs, has the potential to offer significant cost savings to US healthcare payers for the initial treatment of treatment naive patients and as a treatment switching option for virologically suppressed patients. DISCLOSURES: This study was funded in full by ViiV healthcare, Brentford, UK. Medical writing to support this study was also funded in full by ViiV Healthcare, Brentford, UK. Butler, Hayward, and Jacob are employees of HEOR Ltd, the company performing this study funded by ViiV Healthcare. Anderson is an employee of GlaxoSmithKline and owns shares in the company. Punekar, Evitt, and Oglesby are employees of ViiV Healthcare and own stocks in GlaxoSmithKline.

A Typology of Existing Machine Learning-Based Predictive Analytic Tools Focused on Reducing Costs and Improving Quality in Health Care: Systematic Search and Content Analysis.

BackgroundConsiderable effort has been devoted to the development of artificial intelligence, including machine learning–based predictive analytics (MLPA) for use in health care settings. The growth of MLPA could be fueled by payment reforms that hold health care organizations responsible for providing high-quality, cost-effective care. Policy analysts, ethicists, and computer scientists have identified unique ethical and regulatory challenges from the use of MLPA in health care. However, little is known about the types of MLPA health care products available on the market today or their stated goals.ObjectiveThis study aims to better characterize available MLPA health care products, identifying and characterizing claims about products recently or currently in use in US health care settings that are marketed as tools to improve health care efficiency by improving quality of care while reducing costs.MethodsWe conducted systematic database searches of relevant business news and academic research to identify MLPA products for health care efficiency meeting our inclusion and exclusion criteria. We used content analysis to generate MLPA product categories and characterize the organizations marketing the products.ResultsWe identified 106 products and characterized them based on publicly available information in terms of the types of predictions made and the size, type, and clinical training of the leadership of the companies marketing them. We identified 5 categories of predictions made by MLPA products based on publicly available product marketing materials: disease onset and progression, treatment, cost and utilization, admissions and readmissions, and decompensation and adverse events.ConclusionsOur findings provide a foundational reference to inform the analysis of specific ethical and regulatory challenges arising from the use of MLPA to improve health care efficiency.