Practice Guidelines for Ocular Telehealth-Diabetic Retinopathy, Third Edition.

Contributors The following document and appendices represent the third edition of the Practice Guidelines for Ocular Telehealth-Diabetic Retinopathy. These guidelines were developed by the Diabetic Retinopathy Telehealth Practice Guidelines Working Group. This working group consisted of a large number of subject matter experts in clinical applications for telehealth in ophthalmology. The editorial committee consisted of Mark B. Horton, OD, MD, who served as working group chair and Christopher J. Brady, MD, MHS, and Jerry Cavallerano, OD, PhD, who served as cochairs. The writing committees were separated into seven different categories. They are as follows: 1.Clinical/operational: Jerry Cavallerano, OD, PhD (Chair), Gail Barker, PhD, MBA, Christopher J. Brady, MD, MHS, Yao Liu, MD, MS, Siddarth Rathi, MD, MBA, Veeral Sheth, MD, MBA, Paolo Silva, MD, and Ingrid Zimmer-Galler, MD. 2.Equipment: Veeral Sheth, MD (Chair), Mark B. Horton, OD, MD, Siddarth Rathi, MD, MBA, Paolo Silva, MD, and Kristen Stebbins, MSPH. 3.Quality assurance: Mark B. Horton, OD, MD (Chair), Seema Garg, MD, PhD, Yao Liu, MD, MS, and Ingrid Zimmer-Galler, MD. 4.Glaucoma: Yao Liu, MD, MS (Chair) and Siddarth Rathi, MD, MBA. 5.Retinopathy of prematurity: Christopher J. Brady, MD, MHS (Chair) and Ingrid Zimmer-Galler, MD. 6.Age-related macular degeneration: Christopher J. Brady, MD, MHS (Chair) and Ingrid Zimmer-Galler, MD. 7.Autonomous and computer assisted detection, classification and diagnosis of diabetic retinopathy: Michael Abramoff, MD, PhD (Chair), Michael F. Chiang, MD, and Paolo Silva, MD.

A "Pathology Explanation Clinic (PEC)" for Patient-Centered Laboratory Medicine Test Results.

This concept paper addresses communication issues arising between physicians and their patients. To facilitate the communication of essential diagnostic pathology information to patients, and address their questions and concerns, we propose that "Pathology Explanation Clinics" be created. The Pathology Explanation Clinics would provide a channel for direct communications between pathologists and patients. Pathologists would receive special training as "Certified Pathologist Navigators" in preparation for this role. The goal of Pathology Explanation Clinics would be to help fill gaps in communication of information contained in laboratory reports to patients, further explain its relevance, and improve patient understanding of the meaning of such information and its impact on their health and health-care choices. Effort would be made to ensure that Certified Pathologist Navigators work within the overall coordination of care by the health-care team.

Second Flexner Century: The Democratization of Medical Knowledge: Repurposing a General Pathology Course Into Multigrade-Level "Gateway" Courses.

Starting in 1910, the "Flexner Revolution" in medical education catalyzed the transformation of the US medical education enterprise from a proprietary medical school dominated system into a university-based medical school system. In the 21st century, what we refer to as the "Second Flexner Century" shifts focus from the education of medical students to the education of the general population in the "4 health literacies." Compared with the remarkable success of the first Flexner Revolution, retrofitting medical science education into the US general population today, starting with K-12 students, is a more daunting task. The stakes are high. The emergence of the patient-centered medical home as a health-care delivery model and the revelation that medical errors are the third leading cause of adult deaths in the United States are drivers of population education reform. In this century, patients will be expected to assume far greater responsibility for their own health care as full members of health-care teams. For us, this process began in the run-up to the "Second Flexner Century" with the creation and testing of a general pathology course, repurposed as a series of "gateway" courses on mechanisms of diseases, suitable for introduction at multiple insertion points in the US education continuum. In this article, we describe nomenclature for these gateway courses and a "top-down" strategy for creating pathology coursework for nonmedical students. Finally, we list opportunities for academic pathology departments to engage in a national "Democratization of Medical Knowledge" initiative.

Flexner 3.0-Democratization of Medical Knowledge for the 21st Century: Teaching Medical Science Using K-12 General Pathology as a Gateway Course.

A medical school general pathology course has been reformatted into a K-12 general pathology course. This new course has been implemented at a series of 7 to 12 grade levels and the student outcomes compared. Typically, topics covered mirrored those in a medical school general pathology course serving as an introduction to the mechanisms of diseases. Assessment of student performance was based on their score on a multiple-choice final examination modeled after an examination given to medical students. Two Tucson area schools, in a charter school network, participated in the study. Statistical analysis of examination performances showed that there were no significant differences as a function of school (F = 0.258, P = .6128), with students at school A having an average test scores of 87.03 (standard deviation = 8.99) and school B 86.00 (standard deviation = 8.18; F = 0.258, P = .6128). Analysis of variance was also conducted on the test scores as a function of gender and class grade. There were no significant differences as a function of gender (F = 0.608, P = .4382), with females having an average score of 87.18 (standard deviation = 7.24) and males 85.61 (standard deviation = 9.85). There were also no significant differences as a function of grade level (F = 0.627, P = .6003), with 7th graders having an average of 85.10 (standard deviation = 8.90), 8th graders 86.00 (standard deviation = 9.95), 9th graders 89.67 (standard deviation = 5.52), and 12th graders 86.90 (standard deviation = 7.52). The results demonstrated that middle and upper school students performed equally well in K-12 general pathology. Student course evaluations showed that the course met the student's expectations. One class voted K-12 general pathology their "elective course-of-the-year."

Telemedicine, telehealth, and mobile health applications that work: opportunities and barriers.

There has been a spike in interest and use of telehealth, catalyzed recently by the anticipated implementation of the Affordable Care Act, which rewards efficiency in healthcare delivery. Advances in telehealth services are in many areas, including gap service coverage (eg, night-time radiology coverage), urgent services (eg, telestroke services and teleburn services), mandated services (eg, the delivery of health care services to prison inmates), and the proliferation of video-enabled multisite group chart rounds (eg, Extension for Community Healthcare Outcomes programs). Progress has been made in confronting traditional barriers to the proliferation of telehealth. Reimbursement by third-party payers has been addressed in 19 states that passed parity legislation to guarantee payment for telehealth services. Medicare lags behind Medicaid, in some states, in reimbursement. Interstate medical licensure rules remain problematic. Mobile health is currently undergoing explosive growth and could be a disruptive innovation that will change the face of healthcare in the future.

Testing a top-down strategy for establishing a sustainable telemedicine program in a developing country: the Arizona telemedicine program-US Army-Republic of Panama Initiative.

OBJECTIVE: Many developing countries have shown interest in embracing telemedicine and incorporating it into their healthcare systems. In 2000, the U.S. Army Yuma Proving Ground (YPG) initiated a program to assist the Republic of Panama in establishing a demonstration Panamanian rural telemedicine program. YPG engaged the Arizona Telemedicine Program (ATP) to participate in the development and implementation of the program. MATERIALS AND METHODS: The ATP recommended adoption of a "top-down" strategy for creating the program. Early buy-in of the Panamanian Ministry of Health and academic leaders was regarded as critical to the achievement of long-term success. RESULTS: High-level meetings with the Minister of Health and the Rectors (i.e., Presidents) of the national universities gained early program support. A telemedicine demonstration project was established on a mountainous Indian reservation 230 miles west of Panama City. Today, three rural telemedicine clinics are linked to a regional Ministry of Health hospital for teleconsultations. Real-time bidirectional videoconferencing utilizes videophones connected over Internet protocol networks at a data rate of 768 kilobits per second to the San Felix Hospital. Telepediatrics, tele-obstetrics, telepulmonology, teledermatology, and tele-emergency medicine services became available. Telemedicine services were provided to the three sites for a total of 1,013 cases, with numbers of cases increasing each year. These three demonstration sites remained in operation after discontinuation of the U.S. involvement in September 2009 and serve as a model program for other telemedicine initiatives in Panama. CONCLUSIONS: Access to the assets of a partner-nation was invaluable in the establishment of the first model telemedicine demonstration program in Panama. After 3 years, the Panamanian Telemedicine and Telehealth Program (PTTP) became self-sufficient. The successful achievement of sustainability of the PTTP after disengagement by the United States fits the Latifi-Weinstein model for establishing telemedicine programs in developing countries.

T-piece resuscitator versus self-inflating bag for preterm resuscitation: an institutional experience.

BACKGROUND: Manual ventilation in the delivery room is provided with devices such as self-inflating bags (SIBs), flow-inflating bags, and T-piece resuscitators. OBJECTIVE: To compare the effect of type of manual ventilation device on overall response to resuscitation among preterm neonates born at < 35 weeks gestation. METHODS: Retrospective data were collected in 2 time periods. Primary outcome was overall response to resuscitation, as measured by Apgar score. Secondary outcomes were incidence of air leaks, need for chest compressions/epinephrine, need for intubation, and surfactant use. RESULTS: We identified 294 resuscitations requiring ventilation. SIB was used for 135 neonates, and T-piece was used for 159 neonates. There was no significant difference between the 1-min and 5-min Apgar scores between SIB and T-piece (P = .77 and P = .11, respectively), nor were there significant differences in secondary outcomes. The rate of rise of Apgar score was higher, by 0.47, with T-piece, compared to SIB (95% CI 0.08-0.87, P = .02). CONCLUSIONS: Although some manikin studies favor T-piece for providing reliable and consistent pressures, our experience did not indicate significant differences in effectiveness of resuscitation between the T-piece and SIB in preterm resuscitations.

Long-term effect of resistant starch on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial.

BACKGROUND: Observational studies report that higher intake of dietary fibre (a heterogeneous mix including non-starch polysaccharides and resistant starches) is associated with reduced risk of colorectal cancer, but no randomised trials with prevention of colorectal cancer as a primary endpoint have been done. We assessed the effect of resistant starch on the incidence of colorectal cancer. METHODS: In the CAPP2 study, individuals with Lynch syndrome were randomly assigned in a two-by-two factorial design to receive 600 mg aspirin or aspirin placebo or 30 g resistant starch or starch placebo, for up to 4 years. Randomisation was done with a block size of 16. Post-intervention, patients entered into double-blind follow-up; participants and investigators were masked to treatment allocation. The primary endpoint for this analysis was development of colorectal cancer in participants randomly assigned to resistant starch or resistant-starch placebo with both intention-to-treat and per-protocol analyses. This study is registered, ISRCTN 59521990. FINDINGS: 463 patients were randomly assigned to receive resistant starch and 455 to receive resistant-starch placebo. At a median follow-up 52·7 months (IQR 28·9-78·4), 53 participants developed 61 primary colorectal cancers (27 of 463 participants randomly assigned to resistant starch, 26 of 455 participants assigned to resistant-starch placebo). Intention-to-treat analysis of time to first colorectal cancer showed a hazard ratio (HR) of 1·40 (95% CI 0·78-2·56; p=0·26) and Poisson regression accounting for multiple primary events gave an incidence rate ratio (IRR) of 1·15 (95% CI 0·66-2·00; p=0·61). For those completing 2 years of intervention, per-protocol analysis yielded a HR of 1·09 (0·55-2·19, p=0·80) and an IRR of 0·98 (0·51-1·88, p=0·95). No information on adverse events was gathered during post-intervention follow-up. INTERPRETATION: Resistant starch had no detectable effect on cancer development in carriers of hereditary colorectal cancer. Dietary supplementation with resistant starch does not emulate the apparently protective effect of diets rich in dietary fibre against colorectal cancer. FUNDING: European Union, Cancer Research UK, Bayer Corporation, National Starch and Chemical Co, UK Medical Research Council, Newcastle Hospitals Trustees, Cancer Council of Victoria Australia, THRIPP South Africa, The Finnish Cancer Foundation, SIAK Switzerland, and Bayer Pharma.

Reconciliation of diverse telepathology system designs. Historic issues and implications for emerging markets and new applications.

Telepathology, the distant service component of digital pathology, is a growth industry. The word "telepathology" was introduced into the English Language in 1986. Initially, two different, competing imaging modalities were used for telepathology. These were dynamic (real time) robotic telepathology and static image (store-and-forward) telepathology. In 1989, a hybrid dynamic robotic/static image telepathology system was developed in Norway. This hybrid imaging system bundled these two primary pathology imaging modalities into a single multi-modality pathology imaging system. Similar hybrid systems were subsequently developed and marketed in other countries as well. It is noteworthy that hybrid dynamic robotic/static image telepathology systems provided the infrastructure for the first truly sustainable telepathology services. Since then, impressive progress has been made in developing another telepathology technology, so-called "virtual microscopy" telepathology (also called "whole slide image" telepathology or "WSI" telepathology). Over the past decade, WSI has appeared to be emerging as the preferred digital telepathology digital imaging modality. However, recently, there has been a re-emergence of interest in dynamic-robotic telepathology driven, in part, by concerns over the lack of a means for up-and-down focusing (i.e., Z-axis focusing) using early WSI processors. In 2010, the initial two U.S. patents for robotic telepathology (issued in 1993 and 1994) expired enabling many digital pathology equipment companies to incorporate dynamic-robotic telepathology modules into their WSI products for the first time. The dynamic-robotic telepathology module provided a solution to the up-and-down focusing issue. WSI and dynamic robotic telepathology are now, rapidly, being bundled into a new class of telepathology/digital pathology imaging system, the "WSI-enhanced dynamic robotic telepathology system". To date, six major WSI processor equipment companies have embraced the approach and developed WSI-enhanced dynamic-robotic digital telepathology systems, marketed under a variety of labels. Successful commercialization of such systems could help overcome the current resistance of some pathologists to incorporate digital pathology, and telepathology, into their routine and esoteric laboratory services. Also, WSI-enhanced dynamic robotic telepathology could be useful for providing general pathology and subspecialty pathology services to many of the world's underserved populations in the decades ahead. This could become an important enabler for the delivery of patient-centered healthcare in the future.

Long-term effect of aspirin on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial.

BACKGROUND: Observational studies report reduced colorectal cancer in regular aspirin consumers. Randomised controlled trials have shown reduced risk of adenomas but none have employed prevention of colorectal cancer as a primary endpoint. The CAPP2 trial aimed to investigate the antineoplastic effects of aspirin and a resistant starch in carriers of Lynch syndrome, the major form of hereditary colorectal cancer; we now report long-term follow-up of participants randomly assigned to aspirin or placebo. METHODS: In the CAPP2 randomised trial, carriers of Lynch syndrome were randomly assigned in a two-by-two factorial design to 600 mg aspirin or aspirin placebo or 30 g resistant starch or starch placebo, for up to 4 years. Randomisation was in blocks of 16 with provision for optional single-agent randomisation and extended postintervention double-blind follow-up; participants and investigators were masked to treatment allocation. The primary endpoint was development of colorectal cancer. Analysis was by intention to treat and per protocol. This trial is registered, ISRCTN59521990. RESULTS: 861 participants were randomly assigned to aspirin or aspirin placebo. At a mean follow-up of 55·7 months, 48 participants had developed 53 primary colorectal cancers (18 of 427 randomly assigned to aspirin, 30 of 434 to aspirin placebo). Intention-to-treat analysis of time to first colorectal cancer showed a hazard ratio (HR) of 0·63 (95% CI 0·35-1·13, p=0·12). Poisson regression taking account of multiple primary events gave an incidence rate ratio (IRR) of 0·56 (95% CI 0·32-0·99, p=0·05). For participants completing 2 years of intervention (258 aspirin, 250 aspirin placebo), per-protocol analysis yielded an HR of 0·41 (0·19-0·86, p=0·02) and an IRR of 0·37 (0·18-0·78, p=0·008). No data for adverse events were available postintervention; during the intervention, adverse events did not differ between aspirin and placebo groups. INTERPRETATION: 600 mg aspirin per day for a mean of 25 months substantially reduced cancer incidence after 55·7 months in carriers of hereditary colorectal cancer. Further studies are needed to establish the optimum dose and duration of aspirin treatment. FUNDING: European Union; Cancer Research UK; Bayer Corporation; National Starch and Chemical Co; UK Medical Research Council; Newcastle Hospitals trustees; Cancer Council of Victoria Australia; THRIPP South Africa; The Finnish Cancer Foundation; SIAK Switzerland; Bayer Pharma.

Technologies for interprofessional education: the interprofessional education-distributed "e-Classroom-of-the-Future".

Communications strategies are central to the planning and execution of interprofessional education (IPE) programs. The diversity of telecommunications-based tools and platforms available for IPE is rapidly expanding. Each tool and platform has a potentially important role to play. The selection, testing, and embedding of tools, such as social networking platforms, within education programs can be very challenging. The goal was to create, in Phoenix, a "command-and-control" video conferencing center (the T-Health Amphitheater or Telehealth Amphitheater) in which tele-consultation patients, located physically at one of the affiliated tele-clinics around the state, could be presented electronically to interprofessional teams of faculty members from the University of Arizona Colleges of Medicine, Nursing, Pharmacy, and Public Health, as well as those from the allied health colleges of other universities in Arizona, for interprofessional team training in a virtual classroom setting. The T-Health video conferencing facility was designed and built. Early assessments show that its novel learning environment is student- and faculty-friendly. T-Health Amphitheater's pair of innovative visible social networking platforms (eStacks™ and eSwaps™) may help break down some of the traditional communications barriers encountered in healthcare IPE and medical practices.

Overview of telepathology, virtual microscopy, and whole slide imaging: prospects for the future.

Telepathology, the practice of pathology at a long distance, has advanced continuously since 1986. Today, fourth-generation telepathology systems, so-called virtual slide telepathology systems, are being used for education applications. Both conventional and innovative surgical pathology diagnostic services are being designed and implemented as well. The technology has been commercialized by more than 30 companies in Asia, the United States, and Europe. Early adopters of telepathology have been laboratories with special challenges in providing anatomic pathology services, ranging from the need to provide anatomic pathology services at great distances to the use of the technology to increase efficiency of services between hospitals less than a mile apart. As to what often happens in medicine, early adopters of new technologies are professionals who create model programs that are successful and then stimulate the creation of infrastructure (ie, reimbursement, telecommunications, information technologies, and so on) that forms the platforms for entry of later, mainstream, adopters. The trend at medical schools, in the United States, is to go entirely digital for their pathology courses, discarding their student light microscopes, and building virtual slide laboratories. This may create a generation of pathology trainees who prefer digital pathology imaging over the traditional hands-on light microscopy. The creation of standards for virtual slide telepathology is early in its development but accelerating. The field of telepathology has now reached a tipping point at which major corporations now investing in the technology will insist that standards be created for pathology digital imaging as a value added business proposition. A key to success in teleradiology, already a growth industry, has been the implementation of standards for digital radiology imaging. Telepathology is already the enabling technology for new, innovative laboratory services. Examples include STAT QA surgical pathology second opinions at a distance and a telehealth-enabled rapid breast care service. The innovative bundling of telemammography, telepathology, and teleoncology services may represent a new paradigm in breast care that helps address the serious issue of fragmentation of breast cancer care in the United States and elsewhere. Legal and regulatory issues in telepathology are being addressed and are regarded as a potential catalyst for the next wave of telepathology advances, applications, and implementations.

Virtual slide telepathology enables an innovative telehealth rapid breast care clinic.

An innovative telemedicine-enabled rapid breast care service is described that bundles telemammography, telepathology, and teleoncology services into a single day process. The service is called the UltraClinics Process. Because the core services are at 4 different physical locations, a challenge has been to obtain stat second opinion readouts on newly diagnosed breast cancer cases. To provide same day quality assurance rereview of breast surgical pathology cases, a DMetrix DX-40 ultrarapid virtual slide scanner (DMetrix Inc, Tucson, AZ) was installed at the participating laboratory. Glass slides of breast cancer and breast hyperplasia cases were scanned the same day the slides were produced by the University Physicians Healthcare Hospital histology laboratory. Virtual slide telepathology was used for stat quality assurance readouts at University Medical Center, 6 miles away. There was complete concurrence with the primary diagnosis in 139 (90.3%) of cases. There were 4 (2.3%) major discrepancies, which would have resulted in a different therapy and 3 (1.9%) minor discrepancies. Three cases (1.9%) were deferred for immunohistochemistry. In 2 cases (1.3%), the case was deferred for examination of the glass slides by the reviewing pathologists at University Medical Center. We conclude that the virtual slide telepathology quality assurance program found a small number of significant diagnostic discrepancies. The virtual slide telepathology program service increased the job satisfaction of subspecialty pathologists without special training in breast pathology, assigned to cover the general surgical pathology service at a small satellite university hospital.

Virtual slide telepathology for an academic teaching hospital surgical pathology quality assurance program.

Virtual slide telepathology is an important potential tool for providing re-review of surgical pathology cases as part of a quality assurance program. The University of Arizona pathology faculty has implemented a quality assurance program between 2 university hospitals located 6 miles apart. The flagship hospital, University Medical Center (UMC), in Tucson, AZ, handles approximately 20 000 surgical pathology specimens per year. University Physicians Healthcare Hospital (UPHH) at Kino Campus has one tenth the volume of surgical pathology cases. Whereas UMC is staffed by 10 surgical pathologists, UPHH is staffed daily by a single part-time pathologist on a rotating basis. To provide same-day quality assurance re-reviews of cases, a DMetrix DX-40 ultrarapid virtual slide scanner (DMetrix, Inc, Tucson, AZ) was installed at the UPHH in 2005. Since then, glass slides of new cases of cancer and other difficult cases have been scanned the same day the slides are produced by the UPHH histology laboratory. The pathologist at UPHH generates a provisional written report based on light microscopic examination of the glass slides. At 2:00 pm each day, completed cases from UPHH are re-reviewed by staff pathologists, pathology residents, and medical students at the UMC using the DMetrix Iris virtual slide viewer. The virtual slides are viewed on a 50-in plasma monitor. Results are communicated with the UPHH laboratory by fax. We have analyzed the results of the first 329 consecutive quality assurance cases. There was complete concordance with the original UPHH diagnosis in 302 (91.8%) cases. There were 5 (1.5%) major discrepancies, which would have resulted in different therapy and/or management, and 10 (3.0%) minor discrepancies. In 6 cases (1.8%), the diagnosis was deferred for examination of the glass slides by the reviewing pathologists at UMC, and the diagnosis of another 6 (1.8%) cases were deferred pending additional testing, usually immunohistochemistry. Thus, the quality assurance program found a small number of significant diagnostic discrepancies. We also found that implementation of a virtual slide telepathology quality assurance service improved the job satisfaction of academic subspecialty pathologists assigned to cover on-site surgical pathology services at a small, affiliated university hospital on a rotating part-time basis. These findings should be applicable to some community hospital group practices as well.

Virtual slide telepathology enables an innovative telehealth rapid breast care clinic.

An innovative telemedicine-enabled rapid breast care service is described that bundles telemammography, telepathology, and teleoncology services into a single day process. The service is called the UltraClinics Process. Since the core services are at four different physical locations a challenge has been to obtain STAT second opinion readouts on newly diagnosed breast cancer cases. In order to provide same day QA re-review of breast surgical pathology cases, a DMetrix DX-40 ultrarapid virtual slide scanner (DMetrix, Inc., Tucson, AZ) was installed at the participating laboratory. Glass slides of breast cancer and breast hyperplasia cases were scanned the same day the slides were produced by the University Physicians Healthcare Hospital histology laboratory. Virtual slide telepathology was used for STAT quality assurance readouts at University Medical Center, 6 miles away. There was complete concurrence with the primary diagnosis in 139 (90.3%) of cases. There were 4 (2.3%) major discrepancies, which would have resulted in a different therapy and 3 (1.9%) minor discrepancies. Three cases (1.9%) were deferred for immunohistochemistry. In 2 cases (1.3%), the case was deferred for examination of the glass slides by the reviewing pathologists at University Medical Center. We conclude that the virtual slide telepathology QA program found a small number of significant diagnostic discrepancies. The virtual slide telepathology program service increased the job satisfaction of subspecialty pathologists without special training in breast pathology, assigned to cover the general surgical pathology service at a small satellite university hospital.

Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch syndrome.

BACKGROUND: Observational and epidemiologic data indicate that the use of aspirin reduces the risk of colorectal neoplasia; however, the effects of aspirin in the Lynch syndrome (hereditary nonpolyposis colon cancer) are not known. Resistant starch has been associated with an antineoplastic effect on the colon. METHODS: In a randomized, placebo-controlled trial, we used a two-by-two design to investigate the effects of aspirin, at a dose of 600 mg per day, and resistant starch (Novelose), at a dose of 30 g per day, in reducing the risk of adenoma and carcinoma among persons with the Lynch syndrome. RESULTS: Among 1071 persons in 43 centers, 62 were ineligible to participate in the study, 72 did not enter the study, and 191 withdrew from the study. These three categories were equally distributed across the study groups. Over a mean period of 29 months (range, 7 to 74), colonic adenoma or carcinoma developed in 141 participants. Of 693 participants randomly assigned to receive aspirin or placebo, neoplasia developed in 66 participants receiving aspirin (18.9%), as compared with 65 receiving placebo (19.0%) (relative risk, 1.0; 95% confidence interval [CI], 0.7 to 1.4). There were no significant differences between the two groups with respect to the development of advanced neoplasia (7.4% and 9.9%, respectively; P=0.33). Among the 727 participants receiving resistant starch or placebo, neoplasia developed in 67 participants receiving starch (18.7%), as compared with 68 receiving placebo (18.4%) (relative risk, 1.0; 95% CI, 0.7 to 1.4). Advanced adenomas and colorectal cancers were evenly distributed in the two groups. The prevalence of serious adverse events was low, and the events were evenly distributed. CONCLUSIONS: The use of aspirin, resistant starch, or both for up to 4 years has no effect on the incidence of colorectal adenoma or carcinoma among carriers of the Lynch syndrome. (Current Controlled Trials number, ISRCTN59521990.)

Prevalence of adenomas and hyperplastic polyps in mismatch repair mutation carriers among CAPP2 participants: report by the colorectal adenoma/carcinoma prevention programme 2.

PURPOSE: To determine the prevalence of adenomatous and hyperplastic polyps in a large cohort of individuals with a germline mutation in a mismatch repair (MMR) gene, the major genetic determinant of hereditary nonpolyposis colorectal cancer (HNPCC). These prevalences have been estimated previously in smaller studies, and the results have been found to be variable. PATIENTS AND METHODS: Colorectal Adenoma/Carcinoma Prevention Programme 2 trial is a chemoprevention trial in people classified as having HNPCC. The 695 patients with a proven germline MMR mutation and documented screening history before the chemoprevention study were the focus of this study. The number, histology, size, and location of polyps found at the participants' first ever colonoscopy were analyzed in a cross-sectional study. RESULTS: Seventy-four patients (10.6%) were found to have at least one adenoma at first colonoscopy, whereas 37 (5.3%) had at least one hyperplastic polyp. The frequency of an adenoma at first colonoscopy increased from 5.0% (95% CI, 2.8% to 8.3%) in patients younger than 35 years old to 18.9% (95% CI, 9.4% to 32.0%) in patients age at least 55 years (P = .0001 for trend). No such trend was observed for hyperplastic polyps. No sex differences were found for either type of polyp. A marginal association was found between the co-occurrence of adenomas and hyperplastic polyps. Adenomas tended to be more proximally distributed through the colon, whereas hyperplastic polyps tended to be located in the distal colon. CONCLUSION: Adenoma prevalence increases with age among MMR mutation carriers, whereas hyperplastic polyp prevalence is consistent. No sex differences were observed for either type of lesion.

Integrating telemedicine and telehealth: putting it all together.

Telemedicine and telehealth programs are inherently complex compared with their traditional on-site health care delivery counterparts. Relatively few organizations have developed sustainable, multi-specialty telemedicine programs, although single service programs, such as teleradiology and telepsychiatry programs, are common. A number of factors are barriers to the development of sustainable telemedicine and telehealth programs. First, starting programs is often challenging since relatively few organizations have, in house, a critical mass of individuals with the skill sets required to organize and manage a telemedicine program. Therefore, it is necessary to "boot strap" many of the start-up activities using available personnel. Another challenge is to assemble a management team that has time to champion telemedicine and telehealth while dealing with the broad range of issues that often confront telemedicine programs. Telemedicine programs housed within a single health care delivery system have advantages over programs that serve as umbrella telehealth organizations for multiple health care systems. Planning a telemedicine program can involve developing a shared vision among the participants, including the parent organizations, management, customers and the public. Developing shared visions can be a time-consuming, iterative process. Part of planning includes having the partnering organizations and their management teams reach a consensus on the initial program goals, priorities, strategies, and implementation plans. Staffing requirements of telemedicine and telehealth programs may be met by sharing existent resources, hiring additional personnel, or outsourcing activities. Business models, such as the Application Service Provider (ASP) model used by the Arizona Telemedicine Program, are designed to provide staffing flexibility by offering a combination of in-house and out-sourced services, depending on the needs of the individual participating health care organizations. Telemedicine programs should perform ongoing assessments of activities, ranging from service usage to quality of service assessments, to ongoing analyses of financial performance. The financial assessments should include evaluations of costs and benefits, coding issues, reimbursement, account receivables, bad debt and network utilization. Long-range strategic planning for a telemedicine and telehealth program should be carried out on an on-going basis and should include the program's governing board. This planning process should include goal setting and the periodic updating of the program's vision and mission statements. There can be additional special issues for multi-organization telemedicine and telehealth programs. For example, authority management can require the use of innovative approaches tailored to the realities of the organizational structures of the participating members. Inter-institutional relations may introduce additional issues when competing health care organizations are utilizing shared resources. Branding issues are preferably addressed during the initial planning of a multi-organizational telemedicine and telehealth program. Ideally, public policy regarding telemedicine and telehealth within a service region will complement the objectives of telemedicine and telehealth programs within that service area.

Arizona Telemedicine Program Interprofessional Learning Center: facility design and curriculum development.

The Institute for Advanced Telemedicine and Telehealth (i.e., T-Health Institute), a division of the state-wide Arizona Telemedicine Program (ATP), specializes in the creation of innovative health care education programs. This paper describes a first-of-a-kind video amphitheater specifically designed to promote communication within heterogeneous student groups training in the various health care professions. The amphitheater has an audio-video system that facilitates the assembly of ad hoc "in-the-room" electronic interdisciplinary student groups. Off-site faculty members and students can be inserted into groups by video conferencing. When fully implemented, every student will have a personal video camera trained on them, a head phone/microphone, and a personal voice channel. A command and control system will manage the video inputs of the individual participant's head-and-shoulder video images. An audio mixer will manage the separate voice channels of the individual participants and mix them into individual group-specific voice channels for use by the groups' participants. The audio-video system facilitates the easy reconfiguration of the interprofessional electronic groups, viewed on the video wall, without the individual participants in the electronic groups leaving their seats. The amphitheater will serve as a classroom as well as a unique education research laboratory.

Dexamethasone dosing, mechanical ventilation and the risk of cerebral palsy.

OBJECTIVE: Risk factors for cerebral palsy (CP) in premature infants include duration of mechanical ventilation and exposure to postnatal dexamethasone (DEX). Since DEX can reduce the duration of mechanical ventilation, limited DEX exposure could be beneficial. METHODS: This was a retrospective, cohort study of infants of less than 1500 g birth weight surviving to discharge between 1 January 1996 and 30 June 2001 who received postnatal dexamethasone. DEX administration was based only on the need for O2 and/or mechanical ventilation. CP was diagnosed at over 10 months post-conceptional age. Univariate and multivariate analyses were used to determine significant risk factors and the relative contribution of these factors to overall risk of CP. RESULTS: Of 218 eligible infants 162 were followed-up (74%). The CP rate was 27.3%. Significant risk factors for CP included gestational age, ventilator duration, DEX dose, presence of periventricular leukomalacia (PVL), seizures, diagnosis of retinopathy of prematurity (ROP) and use of vasopressors. By multiple logistic regression, ventilator duration, PVL, grade III/IV intraventricular hemorrhage (IVH) and DEX dose were significantly related to CP. By stepwise multiple regression, grade III/IV IVH and ventilator duration were the strongest risk factors, but DEX dose continued to be a significant risk factor. CONCLUSIONS: The risk of CP was significantly related to the total cumulative dose of DEX. This could be due to a smaller exposure to DEX or to a reduced need for mechanical ventilation.