Dataset Information

Regional variation in HIV clinical trials participation in the United States.

ABSTRACT: To ensure generalizability of clinical research results, it is important to enroll a heterogeneous population that is representative of the target clinical population. Earlier studies have found regional variation in participation in human immunodeficiency virus (HIV) clinical trials, with the lowest rates seen in the southern United States. Rates of new HIV diagnoses are highest in the South, highlighting the need for in-depth understanding of disparities in clinical trial participation. We evaluated whether regional variation in study participation remains, and describe factors that facilitate or prevent HIV clinical trial participation by region.A one-time, anonymous, bilingual, self-administered survey was conducted among HIV-infected adults receiving HIV care at all 47 domestic AIDS Clinical Trials Group clinical research sites, with a goal of completing 50 surveys per site. ?(2) tests were used to evaluate differences in knowledge of and participation in HIV clinical trials by region, including Northeast, Midwest, South, and West regions. Multivariable logistic regression was used to estimate odds ratios and 95% confidence intervals (CIs) for the effect of region on knowledge of and participation in HIV clinical trials.Of 2263 completed surveys, 2125 were included in this analysis. The proportion of respondents in the South who reported knowledge of studies (66%) was significantly lower than in the Northeast (76%), Midwest (77%), and West (73%) (P = 0.001). Respondents in the South also were the least likely group to report ever having tried to or having participated in a research study (51%) compared with respondents in the Northeast (60%), Midwest (57%), and West (69%; P < 0.001). After adjusting for age, sex, education, race/ethnicity, tobacco use, and alcohol use, the odds ratio for knowledge of and participation in clinical trials for the Northeast (1.36; 95% CI 1.07-1.72) and West (1.85; 95% CI 1.39-2.45) remained significant compared with the South. African American respondents in the South were the most likely population group to report not understanding research studies (15%) as a reason for not participating, compared with the Northeast (9%), Midwest (8%), and West (6%; P < 0.001).Significant regional variations in knowledge of and participation in HIV clinical trials exist. Our results suggest that increasing awareness and understanding of research studies, particularly among African Americans in the South, may facilitate HIV clinical trial participation that is more representative of the HIV-infected population across the United States.

SUBMITTER: Heumann C

PROVIDER: S-EPMC4356522 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Regional variation in HIV clinical trials participation in the United States.

Heumann Christine C Cohn Susan E SE Krishnan Supriya S Castillo-Mancilla Jose R JR Cespedes Michelle M Floris-Moore Michelle M Smith Kimberly Y KY

Southern medical journal 20150201 2

<h4>Objectives</h4>To ensure generalizability of clinical research results, it is important to enroll a heterogeneous population that is representative of the target clinical population. Earlier studies have found regional variation in participation in human immunodeficiency virus (HIV) clinical trials, with the lowest rates seen in the southern United States. Rates of new HIV diagnoses are highest in the South, highlighting the need for in-depth understanding of disparities in clinical trial pa ...[more]

PMID: 25688896

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Project description:Background and aimsThere are currently several recruitment challenges in randomized controlled trials (RCTs) for inflammatory bowel disease (IBD), which prolong the drug approval process and affect the generalizability of study results. The purpose of this study is to characterize individuals who participate in IBD RCTs and identify factors that could influence future recruitment strategies.MethodsWe performed a cross-sectional study within the IBD Partners cohort comparing patients with current or prior participation in an RCT of medical therapy for IBD to those without any RCT participation. Bivariate statistics were used to compare RCT participation by IBD subtype and by other demographic and disease characteristics, and predictive modeling was used to identify factors predictive of RCT participation. We calculated the percent of the cohort that participated in an RCT during each calendar year from 2011 to 2018 and accessed Clinicaltrials.gov to determine the number of active RCTs for IBD therapies per year during that same period.ResultsA total of 14,747 patients with IBD were included in the analysis and 1116 (7.6%) reported RCT participation at any time. Demographic factors predictive of RCT participation included following at an academic institution [odds ratio (OR) = 1.8; 95% confidence interval (CI) 1.51-2.04) and age 36-75 (OR = 1.7; 95% CI 1.46-1.92). Patients with Crohn's disease were more likely to participate than those with ulcerative colitis (OR = 1.5; 95% CI 1.35-1.77). Patients with more severe disease were more likely to participate, including those with prior IBD-related hospitalization (OR = 2.6; 95% CI 2.19-2.99), IBD-related surgery (OR = 2.5; 95% CI 2.24-2.87), biologic exposure (OR = 3.2; 95% CI 2.76-3.65), and "Poor" or worse quality of life (OR = 1.7; 95% CI 1.45-1.93). Steroid-free remission was associated with a lower likelihood of RCT participation (OR = 0.6; 95% CI 0.53-0.70). Although the number of active RCTs for IBD more than doubled between 2011 and 2018, RCT participation rates during that same time period decreased from 1.1% to 0.7% of the cohort.ConclusionsRCT participation declined within this cohort. Groups underrepresented in RCTs for IBD included younger patients, patients followed in community settings, and patients with more mild disease. The non-RCT group had mean disease activity scores that did not meet remission thresholds, demonstrating populations in need of alternate therapies for whom clinical trials could be an option. Given anti-tumor necrosis factor (TNF) exposure rates in this national cohort, studies should focus on anti-TNF failure populations. Investigators should make every effort to offer RCTs to all patients and network with community providers to increase awareness of RCTs.

Project description:The aim of this study is to assess for regional variation in the incidence of postoperative myocardial infarction (POMI) following nonemergent vascular surgery across the United States to identify potential areas for quality improvement initiatives.We evaluated POMI rates across 17 regional Vascular Quality Initiative (VQI) groups that comprised 243 centers with 1,343 surgeons who performed 75,057 vascular operations from 2010 to 2014. Four procedures were included in the analysis: carotid endarterectomy (CEA, n = 39,118), endovascular abdominal aortic aneurysm (AAA) repair (EVAR, n = 15,106), infrainguinal bypass (INFRA, n = 17,176), and open infrarenal AAA repair (OAAA, n = 3,657). POMI was categorized by the method of diagnosis as troponin-only or clinical/ECG and rates were investigated in regions with ?100 consecutive cases. Regions with significantly different POMI rates were defined as those >1.5 interquartile lengths beyond the 75th percentile of the distribution. Risk-adjusted rates of POMI were assessed using the VQI Cardiac Risk Index all-procedures prediction model to compare the observed versus expected rates for each region.Overall rates of POMI varied by procedure type: CEA 0.8%, EVAR 1.1%, INFRA 2.7%, and OAAA 4.2% (P < 0.001). Significant variation in POMI rates was observed between regions, resulting in differing ranges of POMI rates for each procedure: CEA 0.5-2.0% (P = 0.001), EVAR 0.3-3.1% (P < 0.001), INFRA 1.1-4.8% (P < 0.001), and OAAA 2.2-10.0% (P < 0.001). A single region in 3 of the 4 procedure-specific datasets was identified as a statistical outlier with a significantly higher POMI rate after CEA, EVAR, and OAAA; this region was identical for the EVAR and OAAA datasets but was a different region for the CEA dataset. No significant variation in POMI was noted between regions after INFRA. Procedure-specific clinical POMI rates (mean; range) were significantly different between regions for EVAR (0.4%; 0-1.1%, P = 0.01) and INFRA (1.4%; 0.5-2.9%, P = 0.01), but not for CEA (0.4%; 0-0.8%, P = 0.53) or OAAA (1.6%; 0-3.8%, P = 0.23). Procedure-specific troponin-only POMI rates (mean; range) were significantly different between regions for all procedures: CEA (0.4%; 0.1-1.2%, P < 0.001), EVAR (0.7%; 0-2.1%, P < 0.001), INFRA (1.3%; 0.4-2.5%, P = 0.001), and OAAA (2.5%; 0-8.5%, P < 0.001). After risk adjustment, regional variation was again noted with 3 regions having higher and 4 regions having lower than expected rates of POMI.Significant variation in POMI rates following major vascular surgery exists across VQI regions even after risk adjustment. These findings may present an opportunity for focused regional quality improvement efforts.

Project description:ImportanceWhile computed tomography (CT) represents a tremendous advance in diagnostic imaging, it also creates the problem of incidental detection-the identification of tumors unrelated to the clinical symptoms that initiate the test.ObjectiveTo determine the geographic variation in the United States in CT imaging and the corresponding association with one of the most consequential sequelae of incidental detection: nephrectomy.Design, setting, and participantsThis study is a cross-sectional analysis of age-, sex-, and race-adjusted Medicare data (January 2010-December 2014) from 306 hospital referral regions (HRRs) in the United States and includes information from 15 million fee-for-service Medicare beneficiaries age 65 to 85 years.ExposuresRegional CT risk (ie, the proportion of the population receiving either a chest or abdominal CT over 5 years).Main outcomes and measuresFive-year risk of nephrectomy (partial or total).ResultsData from 15 million fee-for-service Medicare beneficiaries age 65 to 85 years were gathered and illustrate that 43% of Medicare beneficiaries age 65 to 85 years received either a chest or abdominal CT from January 2010 to December 2014. This risk varied across the HRRs, ranging from 31% in Santa Cruz, California, to 52% in Sun City, Arizona. Increased regional CT risk was associated with a higher nephrectomy risk (r = 0.38; 95% CI, 0.28-0.47), particularly among HRRs with more than 50 000 beneficiaries (r = 0.47; 95% CI, 0.31-0.61). After controlling for HRR adult smoking rates, imaging an additional 1000 beneficiaries was associated with 4 additional nephrectomies (95% CI, 3-5). Case-fatality rates for those who underwent nephrectomy were 2.1% at 30 days and 4.3% at 90 days.Conclusions and relevanceFee-for-service Medicare beneficiaries are commonly exposed to CT imaging. Those residing in high-scanning regions face a higher risk of nephrectomy, presumably reflecting the incidental detection of renal masses. Additional surgery should be considered one of the risks of excessive CT imaging.

Project description:BackgroundThe prescription stimulants methylphenidate, amphetamine, and lisdexamfetamine are sympathomimetic drugs with therapeutic use. They are designated in the United States as Schedule II substances, defined by the 1970 Controlled Substances Act as having a "high potential for abuse". Changing criteria for the diagnosis of Attention Deficit Hyperactivity Disorder in 2013 and the approval of lisdexamfetamine for binge eating disorder in 2015 may have impacted usage patterns. This report compared the pharmacoepidemiology of these stimulants in the United States from 2010-2017.MethodsDistribution of amphetamine, methylphenidate, lisdexamfetamine were examined via weights extracted from the Drug Enforcement Administration's (DEA) Automated Reports and Consolidated Ordering System (ARCOS). Median stimulant Daily Dosage per patient was determined for a regional analysis. The percent of cost and prescriptions attributable to each stimulant and atomoxetine in Medicaid from the "Drug Utilization 2018 - National Total" from the Centers for Medicare and Medicaid was determined.ResultsThere was a rise in amphetamine (+67.5%) and lisdexamfetamine (+76.7%) from 2010-2017. The change in methylphenidate (-3.0%) was modest. Persons/day stimulant usage was lower in the West than in other US regions from 2014-2017. There was a negative correlation (r(48) = -0.43 to -0.65, p < .05) between the percent Hispanic population per state and the Daily Dosage/population per stimulant. Methylphenidate formulations accounted for over half (51.7%) of the $3.8 billion reimbursed by Medicaid and the plurality (45.4%) of the 22.0 million prescriptions. Amphetamine was responsible for less than one-fifth (18.4%) of cost but one-third of prescriptions (33.6%). Lisdexamfetamine's cost (26.0%) exceeded prescriptions (16.3%).ConclusionThe rising amphetamine and lisdexamfetamine distribution may correspond with a rise in adult ADHD diagnoses. Regional analysis indicates that stimulant distribution in the West may be distinct from that in other regions. The lower stimulant distribution in areas with greater Hispanic populations may warrant further study.

Project description:ImportanceRepresentative enrollment in clinical trials is critical to ensure equitable and effective translation of research to practice, yet disparities in clinical trial enrollment persist.ObjectiveTo examine person-level factors associated with invitation to and participation in clinical trials.Design, setting, and participantsThis cross-sectional study analyzed responses from 3689 US adults who participated in the nationally representative Health Information National Trends Survey, collected February through June 2020 via mailed questionnaires.ExposuresDemographic, clinical, and health behavior-related characteristics.Main outcomes and measuresHistory of invitation to and participation in a clinical trial, primary information sources, trust in information sources, and motives for participation in clinical trials were described. Respondent characteristics are presented as absolute numbers and weighted percentages. Associations between respondent demographic, clinical, and health behavior-related characteristics and clinical trial invitation and participation were estimated using survey-weighted logistic regression models.ResultsThe median (IQR) age of the 3689 respondents was 48 (33-61) years, and most were non-Hispanic White individuals (2063 [59%]; non-Hispanic Black, 452 [10%]; Hispanic, 521 [14%]), had more than a high school degree (2656 [68%]), were employed (1809 [58%]), and had at least 1 medical condition (2535 [61%]). Overall, 439 respondents (9%) had been invited to participate in any clinical trial. Respondents with increased odds of invitation were non-Hispanic Black compared with non-Hispanic White (adjusted odds ratio [aOR], 1.85; 95% CI, 1.13-3.02), had greater than a high school education compared with less than high school education (eg, ≥college degree: aOR, 4.84; 95% CI, 1.89-12.39), were single compared with married or living as married (aOR, 1.68; 95% CI, 1.04-2.73), and had at least 1 medical condition compared to none (eg, 1 medical condition: aOR, 2.25; 95% CI, 1.32-3.82). Respondents residing in rural vs urban areas had 77% decreased odds of invitation to a clinical trial (aOR 0.33; 95% CI 0.17-0.65). Of invited respondents, 199 (47%) participated. Compared with non-Hispanic White respondents, non-Hispanic Black respondents had 72% decreased odds of clinical trial participation (aOR, 0.28; 95% CI, 0.09-0.87). Respondents most frequently reported "health care providers" as the first and most trusted source of clinical trial information (first source: 2297 [59%]; most trusted source: 2597 [70%]). The most frequently reported motives for clinical trials participation were "wanting to get better" (2294 [66%]) and the standard of care not being covered by insurance (1448 [41%]).Conclusions and relevanceThe findings of this study suggest that invitation to and participation in clinical trials may differ by person-level demographic and clinical characteristics. Strategies toward increasing trial invitation and participation rates across diverse patient populations warrant further research to ensure equitable translation of clinical benefits from research to practice.

Dataset Information

Regional variation in HIV clinical trials participation in the United States.

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Regional variation in HIV clinical trials participation in the United States.

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