Application of a Telecolposcopy Program in Rural Settings.

BACKGROUND: Individuals in rural areas are often restricted by the amount of physicians' availability, thus limiting access to healthcare in those settings. INTRODUCTION: While Pap smear screening has increased across the United States, the rural South still reports high rates of cervical cancer and mortality. One solution to improve patient outcomes related to cervical cancer in rural settings is telecolposcopy. MATERIALS AND METHODS: Women with abnormal Pap results or an abnormal visual examination needing an evaluation by colposcopy were referred to a hospital-based telecolposcopy program. Descriptive data are provided that include patients' access to care based on travel time and transportation costs. RESULTS: Over a 15-month time period, 940 unique patients were seen using telecolposcopy. Telecolposcopy was done at eight spoke sites across Arkansas representing patients from 72 of the 75 counties. Data for risk factors that include smoking, first sexual experience, and number of sexual partners in past 12 months and in a lifetime are discussed. Pap results and impression are provided. In addition, avoided transportation costs and travel time have been calculated and included. DISCUSSION: Cervical cancer is important public health concern especially for women residing in rural areas. We were able to demonstrate that our telecolposcopy program has provided sustainability statewide since its inception and that patients are willing to participate. In addition to providing increased access to care, the program also reduced travel time and costs associated with a face-to-face visit. CONCLUSION: Telecolposcopy should be further explored and utilized in rural settings as a way to reduce patient costs and improve cervical cancer outcomes.

A phase I dose-escalation clinical trial of a peptide-based human papillomavirus therapeutic vaccine with Candida skin test reagent as a novel vaccine adjuvant for treating women with biopsy-proven cervical intraepithelial neoplasia 2/3.

PURPOSE: Non-surgical treatments for cervical intraepithelial neoplasia 2/3 (CIN2/3) are needed as surgical treatments have been shown to double preterm delivery rate. The goal of this study was to demonstrate safety of a human papillomavirus (HPV) therapeutic vaccine called PepCan, which consists of four current good-manufacturing production-grade peptides covering the HPV type 16 E6 protein and Candida skin test reagent as a novel adjuvant. PATIENTS AND METHODS: The study was a single-arm, single-institution, dose-escalation phase I clinical trial, and the patients (n = 24) were women with biopsy-proven CIN2/3. Four injections were administered intradermally every 3 weeks in limbs. Loop electrical excision procedure (LEEP) was performed 12 weeks after the last injection for treatment and histological analysis. Six subjects each were enrolled (50, 100, 250, and 500 µg per peptide). RESULTS: The most common adverse events (AEs) were injection site reactions, and none of the patients experienced dose-limiting toxicities. The best histological response was seen at the 50 µg dose level with a regression rate of 83% (n = 6), and the overall rate was 52% (n = 23). Vaccine-induced immune responses to E6 were detected in 65% of recipients (significantly in 43%). Systemic T-helper type 1 (Th1) cells were significantly increased after four vaccinations (P = 0.02). CONCLUSION: This study demonstrated that PepCan is safe. A significantly increased systemic level of Th1 cells suggests that Candida, which induces interleukin-12 (IL-12) in vitro, may have a Th1 promoting effect. A phase II clinical trial to assess the full effect of this vaccine is warranted.

A novel use of a statewide telecolposcopy network for recruitment of participants in a Phase I clinical trial of a human papillomavirus therapeutic vaccine.

BACKGROUND: Historically, recruitment and retention of young women in intervention-based clinical trials have been challenging. In August 2012, enrollment for a clinical trial testing of an investigational human papillomavirus therapeutic vaccine called PepCan was opened at our institution. This study was an open-label, single-arm, single-institution, dose-escalation Phase I clinical trial. Women with recent Papanicolaou smear results showing high-grade squamous intraepithelial lesions or results that could not rule out high-grade squamous intraepithelial lesion were eligible to enroll. Patients with biopsy-confirmed high-grade squamous intraepithelial lesion were also eligible. Colposcopy was performed at the screening visit, and participants became eligible for vaccination when the diagnosis of high-grade squamous intraepithelial lesion was confirmed with biopsy and other inclusion criteria were met. The aim of this study was to identify strategies and factors effective in recruitment and retention of study participants. METHODS: Potential vaccine candidates were recruited through direct advertisement as well as referrals, including referrals through the Arkansas telecolposcopy network. The network is a federally funded program, administered by physicians and advanced practice nurses. The network telemedically links rural health sites and allows physician-guided colposcopy and biopsies to be conducted by advanced practice nurses. A variety of strategies were employed to assure good retention, including face-to-face contact with the study coordinator at the time of consent and most of study visits; frequent contact using text messaging, phone calls, and e-mails; and creation of a private Facebook page to improve communication among research staff and study participants. A questionnaire, inquiring about motivation for joining the study, occupation, education, household income, number of children, and number of sexual partners, was administered at the screening visit with the intent of identifying factor(s) associated with recruitment and retention. RESULTS: A total of 37 participants were enrolled between September 2012 and March 2014. The largest proportion of participants (46%) was enrolled from the telecolposcopy network. Others were enrolled through outside institutions (43%), in-house referrals (8%), or direct advertisement (3%). Most participants were motivated to join the study to take care of their health issues. Only two participants joined the Facebook private page. Of the 24 participants who qualified for vaccination, only 1 terminated early due to an unanticipated move. CONCLUSION: The availability of a large number of potential participants from the telecolposcopy network increased recruitment to this clinical trial by 85% over other traditional means of recruitment. The telecolposcopy network is not only a means of providing a gynecological service to women who otherwise would forego care but also a novel and valuable resource in recruiting participants for a clinical trial.

Paintings from the Cushing/Whitney Library of Yale University: the Eleventh Kenneth Fitzpatrick Russell Memorial Lecture - 2012.

In the early years of the introduction of Christianity into China, one American medical missionary distinguished himself by his kindness and generosity towards the Chinese people, and also by his surgical prowess. Peter Parker (1804-1888) was a graduate from the Yale University Medical School and was also an ordained minister. He came to the south China city of Canton (now called Guangzhou) in 1834, built a hospital, treated the patients without charge and also groomed medical apprentices to help him in his work. He so impressed a Chinese artist, Lam Qua (1801-1860) that Lam offered to paint in oil, without charge, some of the unusual patients of Parker. Parker stayed in China until 1857. Altogether, there are about 109 paintings. More than 80 of them are in the Harvey Cushing/John Hay Whitney Medical Historical Library of the Yale University Medical School, New Haven, and 23 of them are in Guy's Hospital, London. A description of some of the paintings, together with accounts of Parker and Lam are discussed.

Telemedical cervical cancer screening to bridge medicaid service care gap for rural women.

BACKGROUND: The Arkansas Medicaid program for low-income women provides cervical cancer screening, in the form of Pap smears, and treatment but no diagnostic means of bridging the two, such as a procedure called "colposcopy." Telemedicine offers a viable means to bridging this gap. Previously telecolposcopy has been used in small demonstration projects as a means to deliver colposcopy services to at-risk rural populations at a comparable quality to in-person colposcopy. SUBJECTS AND METHODS: The University of Arkansas for Medical Sciences' Antenatal & Neonatal Guidelines, Education and Learning System Program and Center for Distance Health developed an innovative collaborative telemedicine pilot program with the Arkansas Department of Health that used both specialty physician oversight and nurse examiners. Underserved rural patients from the Department of Health were provided with colposcopy services via interactive telemedicine at four separate spoke sites. During each weekly 3-h clinic, an advanced practice nurse/nurse practitioner at each of the spoke sites performed the exams and collected biopsy specimens under the real-time, interactive supervision of an experienced faculty member at the hub site. RESULTS: Between January 1, 2010 and June 21, 2011, the program scheduled 1,812 visits, involving 1,504 unduplicated patient referrals from 68 of Arkansas's 75 counties, and performed 1,298 telecolposcopic exams. CONCLUSIONS: This project provides complex specialty gynecological services using telemedicine technology to overcome geographic barriers to care while producing results comparable to traditional examinations. It is cost-effective and well received by patients and can be used as a model for improving access to care among vulnerable populations.

The relationship between 'wild' and 'building' isolates of the dry rot fungus Serpula lacrymans.

Molecular and morphological parameters of Serpula lacrymans isolates from various sites in the built environment in Europe and Australia were compared to similar parameters of 'wild' isolates from India, the Sumava Mountains (Czech Republic) and Mount Shasta (USA). The Indian, Czech Republic and all of the building isolates bar one showed identity in both molecular and morphological features. The Australian and the USA isolates (BF-050 and USA'94 respectively) showed specific morphological differences and could be separated on the basis of randomly amplified polymorphic deoxyribonucleic acid polymerase chain reaction (RAPD PCR) with the USA isolate being least closely related to the S. lacrymans type strain of FPRL12C. ITS sequence data revealed two base differences between FPRL12C and BF-050 in the 673 sequenced, nine differences between FPRL12C and USA'94 and 16 differences between USA'94 and the closely related organism Serpula himantioides. The possible evolutionary relationships between the various isolates are discussed along with suggestions for the origin of S. lacrymans as a scourge of the built environment in many temperate areas of the world.