Perelman School of Medicine
Perelman School of Medicine's mission is to advance knowledge and improve health through research, patient care, and the education of trainees in an inclusive culture that embraces diversity, fosters innovation, stimulates critical thinking, supports lifelong learning, and sustains our legacy of excellence.
- Center for Public Health Initiatives
- Department of Biostatistics, Epidemiology and Informatics
- Department of Family Medicine and Community Health
- Department of Medical Ethics and Health Policy
- Department of Microbiology Papers
- Department of Obstetrics and Gynecology
- Department of Psychiatry
- Department of Systems Pharmacology and Translational Therapeutics
- Botswana-UPenn Partnership
- Center for Cognitive Neuroscience
- Global Health Programs
- Medical Physics Programs
A Pragmatic Analysis of the Regulation of Consumer Transcranial Direct Current Stimulation (TDCS) Devices in the United States
2015-10-01, Wexler, Anna
Several recent articles have called for the regulation of consumer transcranial direct current stimulation (tDCS) devices, which provide low levels of electrical current to the brain. However, most of the discussion to-date has focused on ethical or normative considerations; there has been a notable absence of scholarship regarding the actual legal framework in the United States. This article aims to fill that gap by providing a pragmatic analysis of the consumer tDCS market and relevant laws and regulations. In the five main sections of this manuscript, I take into account (a) the history of the do-it-yourself tDCS movement and the subsequent emergence of direct-to-consumer devices; (b) the statutory language of the Federal Food, Drug and Cosmetic Act and how the definition of a medical device—which focuses on the intended use of the device rather than its mechanism of action—is of paramount importance for discussions of consumer tDCS device regulation; (c) how both the Food and Drug Administration (FDA) and courts have understood the FDA's jurisdiction over medical devices in cases where the meaning of ‘intended use’ has been challenged; (d) an analysis of consumer tDCS regulatory enforcement action to-date; and (e) the multiple US authorities, other than the FDA, that can regulate consumer brain stimulation devices. Taken together, this paper demonstrates that rather than a ‘regulatory gap,’ there are multiple, distinct pathways by which consumer tDCS can be regulated in the United States.
Epidemiology of Methicillin‐Resistant Staphylococcus aureus Bacteremia in Gaborone, Botswana
2009-08-01, Wood, Sarah, Shah, Samir S, Bafana, Maragaret, Ratner, Adam J, Meaney, Peter A, Malefho, Kolaatamo C.S, Steenhoff, Andrew P
This cross‐sectional study at a tertiary‐care hospital in Botswana from 2000 to 2007 was performed to determine the epidemiologic characteristics of Staphylococcus aureus bacteremia. We identified a high prevalence (11.2% of bacteremia cases) of methicillin‐resistant S. aureus (MRSA) bacteremia. MRSA isolates had higher proportions of resistance to commonly used antimicrobials than did methicillin‐susceptible isolates, emphasizing the need to revise empiric prescribing practices in Botswana.
Outcomes in HIV-Infected Adults With Tuberculosis at Clinics With and Without Co-Located HIV Clinics in Botswana
2013-10-01, Schwartz, Adam B, Tamuhla, Neo, Steenhoff, Andrew P, Nkakana, Kelebogile, Letlhogile, Rona, Chadborn, Tim R, Kestler, Mary, Zetola, Nicola M, Ravimohan, Shruthi, Bisson, Gregory P
SETTING Gaborone, Botswana. OBJECTIVE To determine if starting anti-tuberculosis treatment at clinics in Gaborone without co-located human immunodeficiency virus (HIV) clinics would delay time to highly active antiretroviral therapy (HAART) initiation and be associated with lower survival compared to starting anti-tuberculosis treatment at clinics with on-site HIV clinics. DESIGN Retrospective cohort study. Subjects were HAART-naïve, aged ≥21 years with pulmonary tuberculosis (TB), HIV and CD4 counts ≤250 cells/mm3 initiating anti-tuberculosis treatment between 2005 and 2010. Survival at completion of anti-tuberculosis treatment or at 6 months post-treatment initiation and time to HAART after anti-tuberculosis treatment initiation were compared by clinic type. RESULTS Respectively 259 and 80 patients from clinics without and with on-site HIV facilities qualified for the study. Age, sex, CD4, baseline sputum smears and loss to follow-up rate were similar by clinic type. Mortality did not differ between clinics without or with on-site HIV clinics (20/250, 8.0% vs. 8/79, 10.1%, relative risk 0.79, 95%CI 0.36–1.72), nor did median time to HAART initiation (respectively 63 and 66 days, P = 0.53). CONCLUSION In urban areas where TB and HIV programs are separate, geographic co-location alone without further integration may not reduce mortality or time to HAART initiation among co-infected patients.
Tear Osmolarity and Dry Eye Symptoms in Women Using Oral Contraception and Contact Lenses
2013-01-01, Chen, Sarah P, Massaro-Giordano, Giacomina, Pistilli, Maxwell, Schreiber, Courtney A, Bunya, Vatinee Y
Purpose—To examine the relationship between oral contraceptive pill (OCP) use, contact lens wear, and dry eye signs and symptoms in healthy young females. Methods—Fifty-two women using OCPs and forty-five women not using any form of hormonal contraception were enrolled. Medical, menstrual, and contact lens histories were obtained and dry eye symptoms were assessed using the Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE) questionnaires. Tear osmolarity testing was performed using the TearLab™ Osmolarity System. Results—Mean age of all subjects was 26.0 ± 3.7 years. There were no significant differences in any of the measurements between the follicular and luteal phases. While SANDE scores were significantly higher in subjects with OCP and recent contact lens use (p<0.01), there were no significant differences in OSDI and tear osmolarity amongst the same subject groups. Subjects who reported both OCP and recent contact lens use had significantly higher OSDI and SANDE scores (p=0.015 and p<0.001, respectively). Conclusions—There were no differences between the phases of the menstrual cycle. Tear osmolarity was not affected by OCP or contact lens use in young females. However, the combination of OCP use and contact lens wear may increase the severity of dry eye symptoms.
Use of Mobile Telemedicine for Cervical Cancer Screening
2011-06-01, Quinley, Kelly E, Gormley, Rachel H, Ratcliffe, Sarah, Shih, Ting, Szep, Zsofia, Steiner, Ann, Ramogola-Masire, Doreen, Kovarik, Carrie
Visual inspection of the cervix with application of 4% acetic acid (VIA) is an inexpensive alternative to cytology-based screening in areas where resources are limited, such as in many developing countries. We have examined the diagnostic agreement between off-site (remote) expert diagnosis using photographs of the cervix (photographic inspection with acetic acid, PIA) and in-person VIA. The images for remote evaluation were taken with a mobile phone and transmitted by MMS. The study population consisted of 95 HIV-positive women in Gaborone, Botswana. An expert gynaecologist made a definitive positive or negative reading on the PIA results of 64 out of the 95 women whose PIA images were also read by the nurse midwives. The remaining 31 PIA images were deemed insufficient in quality for a reading by the expert gynaecologist. The positive nurse PIA readings were concordant with the positive expert PIA readings in 82% of cases, and the negative PIA readings between the two groups were fully concordant in 89% of cases. These results suggest that mobile telemedicine may be useful to improve access of women in remote areas to cervical cancer screening utilizing the VIA `see-andtreat' method.
Study Protocol: Implementation of a Computer-Assisted Intervention for Autism in Schools: A Hybrid Type II Cluster Randomized Effectiveness-Implementation Trial
2016-01-01, Pellecchia, Melanie, Beidas, Rinad S, Marcus, Steven C, Fishman, Jessica, Kimberly, John R., Cannuscio, Carolyn C, Reisinger, Erica M, Rump, Keiran, Mandell, David S
Background: The number of children diagnosed with autism has rapidly outpaced the capacities of many public school systems to serve them, especially under-resourced, urban school districts. The intensive nature of evidence-based autism interventions, which rely heavily on one-to-one delivery, has caused schools to turn to computer-assisted interventions (CAI). There is little evidence regarding the feasibility, effectiveness, and implementation of CAI in public schools. While CAI has the potential to increase instructional time for students with autism, it may also result in unintended consequences such as reduction in the amount of interpersonal (as opposed to computerized) instruction students receive. The purpose of this study is to test the effectiveness of one such CAI—TeachTown—its implementation, and its effects on teachers’ use of other evidence-based practices. Methods:This study protocol describes a type II hybrid cluster randomized effectiveness-implementation trial. We will train and coach 70 teachers in autism support classrooms in one large school district in the use of evidence-based practices for students with autism. Half of the teachers then will be randomly selected to receive training and access to TeachTown: Basics, a CAI for students with autism, for the students in their classrooms. The study examines: (1) the effectiveness of TeachTown for students with autism; (2) the extent to which teachers implement TeachTown the way it was designed (i.e., fidelity); and (3) whether its uptake increases or reduces the use of other evidence-based practices. Discussion: This study will examine the implementation of new technology for children with ASD in public schools and will be the first to measure the effectiveness of CAI. As importantly, the study will investigate whether adding a new technology on top of existing practices increases or decreases their use. This study presents a unique method to studying both the implementation and exnovation of evidence-based practices for children with autism in school settings. Trial registration: NCT02695693. Retrospectively registered on July 8, 2016.
Guatemala & the University of Pennsylvania: Meeting in the Middle
2013-01-01, Barg, Frances K, Weiss, Eve, Branas, Charles
The GUATEMALA-PENN relationship is a partnership that is borne from more than a century of research, service and scholarship. Our goal, with this book and with our programs, is to grow this partnership based upon the reciprocal needs of our Guatemalan stakeholders and the mission of the university. Guatemala is only one country away from the US. Our shared heritage and joint economic and social interests make it critical to foster a strong and mutually beneficial relationship between our two countries. Our connections have evolved over time in response to new knowledge gained about each other. This book is a testament to our collective past, present and future. For more information or to donate visit: http://www.med.upenn.edu/globalhealth/guatemalapartners.shtml
Diabetes Mellitus in HIV-Infected Patients Receiving Antiretroviral Therapy
2013-10-11, Moyo, D, Tanthuma, G, Mushisha, O, Kwadiba, G, Chikuse, F, Cary, Mark S, Steenhoff, Andrew P, Reid, Michael J. A
Background. There is little in the literature on HIV and diabetes mellitus (DM) in sub-Saharan Africa. Objective. To assess the characteristics of HIV and DM in patients receiving antiretroviral therapy (ART) in Botswana. Methods. A retrospective case-control study was conducted at 4 sites. Each HIV-infected patient with DM (n=48) was matched with 2 HIV-infected controls (n=108) by age (±2 years) and sex. Primary analysis was conditional logistic regression to estimate univariate odds and 95% confidence intervals (CIs) for each characteristic. Results. There was no significant association between co-morbid diseases, tuberculosis, hypertension or cancer and risk of diabetes. DM patients were more likely to have higher pre-ART weight (odds ratio (OR) 1.09; 95% CI 1.04 - 1.14). HIV-infected adults >70 kg were significantly more likely to have DM (OR 12.30; 95% CI 1.40 - 107.98). Participants receiving efavirenz (OR 4.58; 95% CI 1.44 - 14.57) or protease inhibitor therapy (OR 20.7; 95% CI 1.79 - 240.02) were more likely to have DM. Neither mean pre-ART CD4 cell count (OR 1.0; 95% CI 0.99 - 1.01) nor pre-ART viral load >100 000 copies/ml (OR 0.71; 95% CI 0.21 - 2.43) were associated with a significant risk of diabetes. Conclusions. These findings suggest a complex interrelation among traditional host factors and treatment-related metabolic changes in the pathogenesis of DM inpatients receiving ART. Notably, pre-ART weight, particularly if >70 kg, is associated with the diagnosis of diabetes in HIV-infected patients in Botswana.
Cognitive-Behavioral Treatment of Anxious Youth with Comorbid School Refusal: Clinical Presentation and Treatment Response
2010-01-01, Beidas, Rinad S, Crawley, Sarah A, Mychailyszyn, Matthew P, Comer, Jonathan S, Kendall, Phillip C
The present study investigated the effectiveness of cognitive-behavioral therapy in youth (N = 27) diagnosed with a principal anxiety disorder and school refusal (SR; denial to attend school or difficulty remaining in school). Scant research examines the effectiveness of cognitive-behavioral therapy for treatment-seeking youth with a primary anxiety disorder and comorbid SR. Effects for youth who completed treatment (N = 12) ranged from d = .61 to 2.27 based on youth- and parent-reported anxiety and depressive symptoms, as well as independently rated global functioning. A discussion of treatment drop-out, a case illustration, and treatment recommendations are provided.