Characterizing Direct-to-Consumer Stem Cell Businesses in the Southwest United States.
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ABSTRACT:
SUBMITTER: Frow EK
PROVIDER: S-EPMC6700498 | biostudies-literature | 2019 Aug
REPOSITORIES: biostudies-literature
Publications
Characterizing Direct-to-Consumer Stem Cell Businesses in the Southwest United States.
Frow Emma K EK Brafman David A DA Muldoon Anna A Krum Logan L Williams Paige P Becker Bryson B Nelson John P JP Pritchett Ashley A
Stem cell reports 20190801 2
There are currently hundreds of businesses across the United States offering direct-to-consumer stem cell treatments that have not been through regulatory approval by the Food and Drug Administration (FDA). Here, we provide a detailed characterization of nearly 170 stem cell businesses operating in the Southwest United States. We draw specific attention to two as-yet understudied facets of these businesses. First, we identify differences in the degree to which a given business focuses their prac ...[more]
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Project description:The value of direct-to-consumer advertising (DTCA) of prescription drugs is widely debated, as is the effect of DTCA on prescription sales and health care utilization.We examined the association between DTCA intensity for statin medications and prescription sales and cholesterol-related health care utilization.We conducted an ecological study for 75 designated market areas from 2005 to 2009 in the United States using linked data regarding televised DTCA volume, non-DTCA marketing and promotion, retail, mail order and long-term care prescription drug sales, prescription drug and ambulatory care health care utilization, and contextual factors such as health care density and socioeconomic status. Main outcomes and measures were volume of sales, number of dispensed prescriptions, and high cholesterol-related outpatient visits. Analyses were conducted in 2016.The intensity of rosuvastatin and atorvastatin ad exposures per household varied substantially across designated market areas. After adjustment for socioeconomic, demographic, and clinical characteristics, each 100-unit increase in advertisement viewership was associated with a 2.22% [95% confidence interval (CI), 0.30%-4.19%] increase in statin sales. Similar patterns were observed between DTCA and statin dispensing among the commercially insured. DTCA was associated with increases in high cholesterol-related outpatient visits among adults 18-45 years of age (3.15% increase in visits per 100-unit increase in viewership, 95% CI, 0.98%-5.37%) but not among those 46-65 years of age (0.51%, 95% CI, -1.49% to 2.55%).DTCA for statins is associated with increases in statin utilization and hyperlipidemia-related outpatient visits, especially for young adults.
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Project description:BackgroundThe Total Worker Health® (TWH) approach is a best practice method to protect and promote worker safety, health, and well-being. Central to this approach is leadership support and health and safety climates that support day-to-day use of health and safety policies and programs. There is some research that supports these relationships, but there is limited research amongst small businesses. Furthermore, it remains to be shown what role TWH business strategies, as reflected by organizational policies and programs, play in this process. The purpose of this study is to characterize small businesses by their organizations' TWH approach and assess the relationship of these approaches to employee health and safety behaviors.MethodsWe utilized cross-sectional data from 97 businesses participating in the Small+Safe+Well study. We collected data using a business assessment tool, Healthy Workplace Assessment™, and an employee assessment tool, Employee Health and Safety Culture Survey. We used latent profile analysis at the business level to identify subgroups of businesses based on a set of characteristics from these assessments. Linear regression analysis at the employee level was used to determine profile association with employee safety and health behaviors.ResultsThere were two profiles characterized by the lowest (33% of all businesses) and highest (9%) levels of the indicators. There were also two profiles with higher scores on two of the different foci on either TWH business strategies (27%) or leadership and climate (31%). Employees working for a business with a profile that focused on leadership and climate, in addition to having a business strategy, reported the best safety and health behaviors.ConclusionsOur study demonstrates that employee engagement in TWH will be highest when businesses have a strategy for how they implement a TWH approach and when they demonstrate leadership commitment to these strategies and foster positive safety and health climates. Our results offer suggestions on how to use TWH assessments to develop interventions for small businesses. More research is needed to understand whether small businesses can improve upon their profile overtime, whether these changes depend on contextual factors, and whether TWH interventions can help them improve their profile.
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| S-EPMC5471355 | biostudies-literature
Project description:The role of gut microbiomes as important regulators of mammalian health is increasingly recognized, although feline and canine gut microbiomes remain poorly characterized. In this proof-of-concept study, we assessed the utility of a direct-to-consumer approach to executing pet microbiome studies. We characterized the gut microbiomes of 238 pets (46 cats and 192 dogs) by generating ~11 million merged reads that were mapped to the V4 region of 16S ribosomal RNA gene at a sequencing depth of 45,806 (±22,325) reads per sample. Analyses of these reads revealed that both feline and canine gut microbiomes are dominated by three major phyla, namely Firmicutes, Proteobacteria, and Bacteroides and that alpha diversity is higher in the feline gut. In addition to interspecies differences between the feline and canine gut, we also detected appreciable intraspecies bacterial variation within the canine population. While the dogs in this dataset could be assigned to three distinct clusters based on their gut microbiome, no clustering was observed within the feline population. Integration of additional data obtained from survey questionnaires revealed that geography and body weight may be associated with canine gut microbiome composition. Furthermore, we found that both the inter and intraspecies differences are more pronounced at finer taxonomic levels, indicating that strain-level investigations may be necessary in the future. This study demonstrates that the direct-to-consumer approach overcomes existing limitations in pet microbiome research, for example, it allows collection of large numbers of pet samples. The direct-to-consumer approach has proven successful in human genomics as well as human microbiomics and this study demonstrates that by building partnerships with an engaged general public this approach can also propel the field of pet microbiomics forward.
| S-EPMC7032713 | biostudies-literature
Project description:IntroductionTelevised direct-to-consumer advertising (DTCA) for prescription drugs is controversial, especially for tobacco cessation products such as varenicline, given safety concerns that arose only after its market approval. We aim to quantify the extent to which DTCA influenced varenicline use.MethodsWe linked monthly DTCA television ratings with monthly prescription data from IMS Health's National Prescription Audit across top 75 media markets in 2006-2009. We used Poisson models with Generalized Estimating Equations to analyze effects of exposures to DTCA for both varenicline and nicotine replacement therapies on rate of dispensed varenicline prescriptions among smokers, controlling for population characteristics and varenicline-related events.ResultsVarenicline prescriptions increased dramatically following DTCA launch and declined sharply after safety risks were publicized and US Food and Drug Administration (FDA) issued an advisory. DTCA had significant impact on new prescription dispensing in the subsequent month: before the FDA advisory, one additional exposure to varenicline DTCA was associated with a 1.8% (rate ratio [RR] = 1.018 [1.015-1.021]) higher rate of new prescriptions; no effect was observed after the advisory (RR = 1.000 [0.997-1.003]). Prior to the advisory, cross-product effects of nicotine replacement therapy advertising on varenicline prescribing were negligible (RR = 1.002 [0.999-1.004]); after the advisory, effects were positive (RR = 1.015 [1.012-1.019]).ConclusionsDTCA for varenicline had a significant impact on varenicline prescribing when the drug's safety profile was not well characterized, supporting arguments to limit DTCA for newly approved products whose real-world safety is unclear.ImplicationsWe examined the fluctuations in varenicline use in association with DTCA for varenicline and other tobacco cessation aids. To our knowledge this is the first study to quantify the effects of televised DTCA for varenicline and other tobacco cessation aids on varenicline prescription dispensing. We believe that understanding these relationships is critical for formulating effective public health policy and interventions.
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Project description:BackgroundClinically, human immunodeficiency virus type 1 (HIV-1) pol sequences are used to evaluate for drug resistance. These data can also be used to evaluate transmission networks and help describe factors associated with transmission risk.MethodsHIV-1 pol sequences from participants at 5 sites in the CFAR Network of Integrated Clinical Systems (CNICS) cohort from 2000-2009 were analyzed for genetic relatedness. Only the first available sequence per participant was included. Inferred transmission networks ("clusters") were defined as ?2 sequences with ?1.5% genetic distance. Clusters including ?3 patients ("networks") were evaluated for clinical and demographic associations.ResultsOf 3697 sequences, 24% fell into inferred clusters: 155 clusters of 2 individuals ("dyads"), 54 clusters that included 3-14 individuals ("networks"), and 1 large cluster that included 336 individuals across all study sites. In multivariable analyses, factors associated with being in a cluster included not using antiretroviral (ARV) drugs at time of sampling (P < .001), sequence collected after 2004 (P < .001), CD4 cell count >350 cells/mL (P < .01), and viral load 10,000-100,000 copies/mL (P < .001) or >100,000 copies/mL (P < .001). In networks, women were more likely to cluster with other women (P < .001), and African Americans with other African Americans (P < .001).ConclusionsMolecular epidemiology can be applied to study HIV transmission networks in geographically and demographically diverse cohorts. Clustering was associated with lack of ARV use and higher viral load, implying transmission may be interrupted by earlier diagnosis and treatment. Observed female and African American networks reinforce the importance of diagnosis and prevention efforts targeted by sex and race.
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Project description:Norovirus is the leading cause of acute gastroenteritis outbreaks in the United States. We estimated the basic (R0) and effective (Re) reproduction numbers for 7,094 norovirus outbreaks reported to the National Outbreak Reporting System (NORS) during 2009-2017 and used regression models to assess whether transmission varied by outbreak setting. The median R0 was 2.75 (interquartile range [IQR] 2.38-3.65), and median Re was 1.29 (IQR 1.12-1.74). Long-term care and assisted living facilities had an R0 of 3.35 (95% CI 3.26-3.45), but R0 did not differ substantially for outbreaks in other settings, except for outbreaks in schools, colleges, and universities, which had an R0 of 2.92 (95% CI 2.82-3.03). Seasonally, R0 was lowest (3.11 [95% CI 2.97-3.25]) in summer and peaked in fall and winter. Overall, we saw little variability in transmission across different outbreaks settings in the United States.
| S-EPMC7392428 | biostudies-literature
Project description:Kissing bugs readily enter homes in the Sonoran Desert and bite the residents. Their saliva is highly antigenic, causing local and systemic skin reactions and life-threatening anaphylaxis. We attempted to determine what characteristics of homesites may have contributed to home intrusion by kissing bugs. Extensive and detailed information about the homes and the home environment was collected from 78 homeowners in Tucson who suffered kissing bug intrusions. Homeowners collected 298 Triatoma rubida in and around their homes. Of the homes entered by kissing bugs, 29 of 46 (63%) contained bugs harboring Trypanosoma cruzi. Although in the aggregate, homeowners were bitten > 2200 times, no individual tested positive for Chagas disease (N = 116). Although yearly intrusion likely occurs in some homes, T. rubida does not domiciliate within homesites in the Desert Southwest. We conclude there is little risk to homeowners for Chagas disease given the current behavior of resident kissing bugs and absent ingesting kissing bug fecal matter.
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Project description:Involvement of clinical pharmacists in the ICU attenuates costs, avoids adverse drug events, and reduces morbidity and mortality. This survey assessed services and activities of ICU pharmacists.DesignA 27-question, pretested survey.Setting1,220 U.S. institutions.SubjectsCritical care pharmacists.InterventionsElectronic questionnaire of pharmacy services and activities across clinical practice, education, scholarship, and administration.Measurements and main resultsA total of 401 (response rate of 35.4%) surveys representing 493 ICUs were completed. Median daily ICU census was 12 (interquartile range, 6-20) beds with 1 (interquartile range, 1-1.5) pharmacist full-time equivalent per ICU. Direct clinical ICU pharmacy services were available in 70.8% of ICUs. Pharmacists attended rounds 5 days (interquartile range, 4-5 d) per week with a median patient-to-pharmacist ratio of 17 (interquartile range, 12-26). The typical workweek consisted of 50% (interquartile range, 40-60%) direct ICU patient care, 10% (interquartile range, 8-16%) teaching, 8% (interquartile range, 5-18%) order processing, 5% (interquartile range, 0-20%) direct non-ICU patient care, 5% (interquartile range, 2-10%) administration, 5% (interquartile range, 0-10%) scholarship, and 0% (interquartile range, 0-5%) drug distribution. Common clinical activities as a percentage of the workweek were reviewing drug histories (28.5%); assessing adverse events (27.6%); and evaluating (26.1%), monitoring (23.8%), and managing (21.4%) drug therapies. Services were less likely to occur overnight or on weekends. Telemedicine was rarely employed. Dependent prescriptive authority (per protocol or via practice agreements) was available to 51.1% of pharmacists and independent prescriptive authority was provided by 13.4% of pharmacists. Educational services most frequently provided were inservices (97.6%) and experiential training of students or residents (89%). Education of ICU healthcare members was provided at a median of 5 times/mo (interquartile range, 3-15 times/mo). Most respondents were involved with ICU or departmental policies/guidelines (84-86.8%) and 65.7% conducted some form of scholarship.ConclusionsICU pharmacists have diverse and versatile responsibilities and provide several key clinical and nonclinical services. Initiatives to increase the availability of services are warranted.
| S-EPMC7803868 | biostudies-literature