Rural health care centers provide low-cost care

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Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

To get dental services she can afford, 73-year-old Juanita Jenkins has one of her sons drive her 16 miles from her home in the Duval neighborhood in northeast Gainesville to the Alachua County Organization for Rural Needs (ACORN) Clinic in Brooker. The 32-mile round trip is worth it, she says.

Jenkins is one of thousands of people in Alachua County and surrounding counties who need the inexpensive services provided by nonprofit organizations, such as ACORN, which was established in 1974 to serve area migrant workers.

“I started coming here last year and I’ve been here to the dentist about four or five times,” said Jenkins, after getting fitted for dentures. “They take good care of you here, and I would recommend their services to anybody.”

Thursday is National Rural Health Day, created to recognize rural health workers for their efforts and their collaborations that address the unique challenges faced in rural communities.

Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

ACORN has grown from a singlewide trailer on a sandy lot of land to several modular buildings that house dental, medical and administrative offices at 23320 N. State Road 235 in Brooker.

The clinic provides a range of medical, dental and mental health care services, referrals to other health services and social services and professional education and training, King said.

Like ACORN, Archer Family Healthcare, an arm of the University of Florida College of Nursing, started out in a small building before moving into a larger building to better serve its patients. According to Joan Newell-Walker, manager of the clinic, retired Dr. Dee Williams lobbied to establish the clinic after being urged to do so by Archer residents. Williams’ efforts led to the clinic opening in 2001, and it has grown from an approximately 1,000-square-foot, two-story bungalow to a more than 5,000-square-foot facility composed of six modular buildings that were built in downtown Archer in 2007.

“We have grown to accommodate approximately 5,000 patient visits annually,” Newell-Walker said.

Patients visit the Archer clinic for a variety of reasons, including chronic diseases like diabetes, hypertension, chronic obstructive pulmonary disease, as well as prenatal care, medication consultations, health education and disease prevention, immunizations, physical exams and more, Newell-Walker said.

The clinic in Archer was established to meet the needs of residents who live in the rural community in southwest Alachua County who didn’t have a health care facility before the clinic opened. But it’s grown to serve patients from throughout North Central Florida, Newell-Walker said.

The clinic’s funding comes from local, state and federal sources, and it’s run by advanced registered nurse practitioners, Newell-Walker said.

The nurse practitioners provide expert care for patients and are supported by other health care professionals, including a case manager, community health nurses and a consulting physician, Newell-Walker said.

At ACORN, a wide variety of dental, medical and mental health care services are provided, including disease management education, general medical care, reduced cost X-rays, women’s health care, dental exams and X-rays, extractions, orthodontics, root canals and more.

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Innovation in education looks to cure doctor shortage

Business News | 20 hours ago |

Arizona has a serious doctor shortage. The state is a “Designated Health Professional Shortage Area” and according to the latest numbers from the Health Resources & Services Administration, the department that makes these designations, slightly less than half of Arizona’s primary care health professional needs are met.

Video by Jesse A. Millard

Since only 49 percent of the state’s needs are met, Arizona residents, particularly those in the rural parts of the state, are subject to long wait times for regular checkups because of the doctor shortage.

Arizona needs to add 520 physicians in order to lose its “shortage” designation. These doctors won’t appear out of thin air, but Arizona does have a great pool to reel new doctors from — its growing medical schools.

Midwestern University’s Arizona campus in Glendale sees an estimated 40 percent of its graduates residing and practicing in Arizona, says Dr. Kathleen H. Goeppinger, president and CEO of Midwestern University.

The University of Arizona College of Medicine in Phoenix offers a pipeline to local communities. The efforts include Saturday Scrubs and Summer Scrubs, where those interested in the medical field are welcomed into simulation labs to watch students care for mannequins — or faux patients. The hope is the program will spark the interest in those considering a career in the medical field.

And Mayo Clinic welcomed its first class of about 50 students to the Valley this year, making Arizona the third state to receive a Mayo Medical school, behind Minnesota and Florida.

The Mayo Clinic School of Medicine has created a curriculum that is designed to not only teach students how to do certain medical procedures, but also teach them the ins and outs of the healthcare delivery system.

“We want to prepare physicians to meet the needs and challenges of the healthcare system,” says Michele Halyard, MD, dean of the Mayo Clinic School of Medicine’s Arizona campus. “We are hoping that many of the students will wind up staying in Arizona for their residency and ultimately becoming a physician within the Arizona community.”

Class act

In late September, several medical groups in the state formed an alliance that will work to increase the number of doctors and healthcare professionals in Arizona and ease the doctor shortage.

Maricopa Integrated Health System, Creighton University School of Medicine, Dignity Health’s St. Joseph’s Hospital and Medical Center and District Medical Group will work together as the Creighton University Arizona Health Education Alliance to expand Arizona’s offerings of healthcare education programs.

“With this alliance, we have the opportunity to continue to strengthen Arizona’s reputation as the home of some of the best medicine in the nation,” says Patty White, president and CEO of St. Joseph’s. “The affiliation will enable us to increase the numbers of doctors and other healthcare professionals who will want to make Arizona their home.”

Arizona is also on the cutting edge of medical education, training and creating doctors who will be prepared to deliver care in a modern healthcare setting.

This is being done through various medical simulation centers in the state. Simulation is still fairly new in medical training and preparation. However, many medical schools across Arizona are adopting this new practice in hopes of producing better trained physicians.

Simulation centers vary from facility to facility, but they typically involve mannequins that enable students, practitioners and residents to learn how to deal with many different aspects of medical care and treatment.

Innovation abounds

The Banner Simulation Medical Center’s 55,000-square-foot simulation center is one of the largest simulation centers in Arizona, where trainees can fully experience a hospital-like atmosphere.

The center is nestled in a decommissioned, hospital where students can immerse themselves in simulations at an intensive care unit, surgery center, operating rooms and training labs. Students learn how to take blood samples, utilize proper sanitary measures and more, says Karen Josey, senior director of simulation at Banner Health.

“Simulation is all about patient safety,” Josey says. “Simulation goes from simple training such as putting in an IV, to the more complex tasks and scenarios, such as a chest tube insertion.”

The center also offers a day in the life of a nurse, where students are assigned a number of patients that they must watch, prioritize and care for throughout the day. This is followed by hours of debriefing on what needs to be improved and what was done correctly.

The University of Arizona currently has two simulation labs. One located in Tucson — which will open in May of 2018 — and one in Phoenix.

The Phoenix simulation center consists of three wings, 14 hospital rooms, two surgical stations, nine debriefing rooms, six onsite training rooms, three scrub sinks, ultrasound machines, 3-D models of the brain and eyes and a virtual reality simulation.

All of this is in hopes of accomplishing the UA’s “mission of providing the best training to students, residents and fellows, but it also helps recruit and expand our pipeline of students who might consider entering careers in medical fields,” says Guy Reed, dean of the University of Arizona College of Medicine – Phoenix.

Midwestern University is also home to a simulation lab. Its lab is made up of 19 exam rooms and extends to seven veterinary-based exam rooms. Also, there’s an ICU, emergency/trauma room, a pediatric floor, maternal fetal simulator, operating rooms and more.

Arizona is filled with simulation labs, including two more with Mayo Clinic. Mayo’s facility contains about six fully equipped exam rooms that are identical to those in the Mayo Clinic Cancer Center, and another simulation center within its hospital.

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Women’s Forum panel addresses women’s health, education challenges

nsWGLFNotecard-CourtesyWGLF

 

Health and education challenges that women face were the center of a panel discussion which took place Monday morning as part of the Women’s Global Leadership Forum.

Courtesy Women’s Global Leadership Forum

 

A panel addressing health and education challenges facing women took place Monday morning as part of the Women’s Global Leadership Forum. The discussion was facilitated by Rebecca Dillingham, director of the University’s Center for Global Health, and was comprised of of women who gave their global perspectives on the issues.

Newcomb Ballroom was packed with an audience that included high schoolers, University students, alumni and faculty members.

Vivian Pinn, the first full-time director of the Office of Research on Women’s Health at the National Institutes of Health, spoke briefly about being the first African-American female graduate from the University Medical School.

“I went into that first morning class in the fall of 1963 thinking that when I looked around the room and saw only white men — that the other women and people of color must just be late getting there,” Pinn said. “Then I realized that I was it. It was me and my classmates.”

Pinn said one of her main priorities she has pursued throughout her life is trying to ensure the medical world listens to women and discusses women’s health.

“I have focused on things that have been important to me my whole life,” Pinn said. “That is — What about the health of girls and women? What about girls getting careers in medicine? I couldn’t think of a better time to focus my energy on women’s health.”

The panel centralized their conversation on the importance of enabling education at a young level to facilitate greater gender equality amongst leadership roles.

Maya Ajmera, president and CEO of the Society for Science and the Public, spoke about her trip to India in which she saw train platform schools. The trip inspired her Global Fund for Children which works on behalf of vulnerable children. Ajmera said in the future she wants to focus on empowering local, grassroots organizations to enact change.

“Grassroot entrepreneurs …  They are the ones that resources really need to get put into because I think they’ve been starved,” Ajmera said. “I think they’ve been starved in this country, but I also see that starvation globally. So if we’re going to reach people, it’s through the grassroots.”

Ajmera also said one of her main priorities is to ensure that girls continue their education beyond primary school.

“We have to get the education of girls at the secondary level globally up,” Ajmera said. “The development goals of the U.N. have achieved great success in getting primary school admissions very high. But secondary school really has to be an emphasis.”

Abinet Sitotaw, a gender and nutrition advisor for nonprofit organization CARE-Ethiopia also said education was important in promoting women and girl’s empowerment. Speaking of her own personal mission and the Mandela Washington Fellowship, Sitotaw said her priorities involved getting girls into safe educational institutions.

“It’s going to be a leadership academy whereby I manage to bring a group of young girls who cannot attend secondary schools to the city,” Sitotaw said. “I want to give them a boarding school whereby they can get a state of the art education and also leadership skills.”

 

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It is important for non-statisticians to become familiar with biostatistics

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Statistics is extremely useful as a decision-making tool in the clinical research arena. In areas such as working in a field where a p-value can determine the next steps on development of a drug or procedure, it is very handy, because of which it is imperative for decision makers to understand the theory and application of statistics.

Many statistical software applications have now been developed and made available to professionals. It needs to be borne in mind that these software applications were developed for statisticians, because of which its use can baffle non-statisticians. Their confusions could be as basic as pressing the right key, let alone performing the best test.

A full learning session on biostatistics for the non-statistician

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A seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will throw light on the importance of biostatistics for the non-statistician.

Elaine Eisenbeisz, a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California, who has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations to start-up companies and individual researchers; will be the Director of this seminar.

Want to understand the importance of biostatistics for the non-statistician? Then, please enrol for this seminar by visiting It is important for non-statisticians to become familiar with biostatistics. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Statistical concepts in clinical research

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Designed essentially for non-statisticians; this seminar provides a non-mathematical introduction to biostatistics. It will be of high value to professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

Elaine will equip participants of this seminar with the information and skills necessary to understand statistical concepts and findings as they relate to clinical research. With this information, they will be able to confidently communicate with people with whom they need to.

Elaine will place emphasis on the actual statistical concepts, application, and interpretation. She will not go into the areas of mathematical formulas or actual data analysis. A basic understanding of statistics is desired from the participants, but is not necessary.

This course on biostatistics for the non-statistician will help professionals involved in this area, such as Physicians, Clinical Research Associates, and Clinical Project Managers/Leaders, Sponsors, Regulatory Professionals who use statistical concepts/terminology in reporting, and Medical Writers who need to interpret statistical reports.

Elaine’s agenda for this two-day seminar will consist of the following:

Why Statistics?

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  • Do we really need statistical tests?
  • Sample vs. Population
  • I’m a statistician not a magician! What statistics can and can’t do
  • Descriptive statistics and measures of variability

The many ways of interpretation

  • Confidence intervals
  • p-values
  • effect sizes
  • Clinical vs. meaningful significance

Common Statistical Tests

  • Comparative tests
  • Regression analysis
  • Non-parametric techniques

Bayesian Logic

  • A different way of thinking
  • Bayesian methods and statistical significance
  • Bayesian applications to diagnostics testing
  • Bayesian applications to genetics

Interpreting Statistics – Team Exercise

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  • Team Exercise: Review a scientific paper and learn how to
    • Interpret statistical jargon
    • Look for reproducibility, transparency, bias, and limitations
    • Convey information coherently to non-statisticians

Study power and sample size

  • Review of p-value, significance level, effect size
  • Formulas, software, and other resources for computing a sample size

Developing a Statistical Analysis Plan

Specialized topics/Closing Comments/Q&A

  • Comparing Survival Curves
  • Pharmacokinetics/Pharmacodynamics (PK/PD)
  • Taking a holistic view to study design and interpretation
  • Question and Answer session.

 

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Lonza news Tolvaptan identified as a treatment for autosomal dominant polycystic kidney disease

A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with polycystic kidney disease…

Tolvaptan identified

A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with the most common form of polycystic kidney disease, a condition with no cure.

This is the first treatment that targets a mechanism that directly contributes to the development and growth of the kidney cysts in autosomal dominant polycystic kidney disease

The results of the trial demonstrated tolvaptan’s ability to intervene in a way that slows kidney function decline in this population.

“This is the first treatment that targets a mechanism that directly contributes to the development and growth of the kidney cysts in autosomal dominant polycystic kidney disease,” says Dr Vicente Torres, director of Mayo Clinic’s Translational Polycystic Kidney Disease Center. “This in effect means it may delay the need for a kidney transplant or dialysis in patients with this disease.”

Autosomal dominant polycystic kidney disease is an inherited condition that affects 1 in every 500 to 1,000 individuals in the U.S. This disease is found in all races and sexes. Autosomal dominant polycystic kidney disease, which is the fourth most common cause of end-stage kidney disease, requires dialysis or a kidney transplant.

The disease causes a slow but relentless growth of cysts that damage the kidneys. In addition to negatively affecting the quality of life, the condition also causes hypertension and painful complications. The cysts, which can damage kidneys with their size, can develop in other organs, especially the liver.

Approximately half of individuals with autosomal dominant polycystic kidney disease eventually will require dialysis or kidney transplant by age 60.

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Murj wants to give data collection from implantable medical devices an upgrade

Murj, a new company backed by $4.5 million in new venture financing, is looking to make data collection from implantable heart monitoring and management devices easier and more manageable.

The company was founded by a former Medtronic sales rep who’d previously worked as a product manager on Apple’s iPads. After a few years in sales, Murj founder Todd Butka began thinking about ways to make the data collected by cardiac technologies more easily available to physicians and diagnosticians.

Now the company is coming to market with backing from True Ventures and Social Capital.

Unlike existing technologies that deliver data in static .pdf documents, Murj collects the data and stores it in its own off-premise data warehouses. Using dashboards and other visualization tools doctors can get a better read on what’s going on with their patients’ heart health, Butka claims.

“The information comes from the devices to the implantable devices’ servers… We ping the servers,” Butka explained.

The Murj launch wraps up three years of work developing the technology, which was founded in 2014 and raised its first money in 2015.

The company, based in Santa Cruz, brought on Chris Irving as its lead designer and Patrick Beaulieu, an 18 year veteran of the medical device business, as its chief technical officer.

I think of the company as sort of an Apple Healthkit for implantable devices. If it can expand its scope beyond pacemakers and heart monitors to a broader range of implantables, it could be a pretty big business.

As the population ages, and technologies improve, demand for more persistent diagnostic tools will grow.

In a sense this is part of a number of companies that are trying to provide better tools to manage the data coming off of the sensors that we’ve got all around us.

 

Read More: http://snip.ly/kvqol#https://techcrunch.com/2017/04/18/murj-wants-to-give-data-collection-from-wearable-devices-an-upgrade/

Testing GxP system that is FDA-compliant

Testing GxP system that is FDA-compliant

Process validation is the method of using data from stages ranging from the process design stage to production, to ensure that the process that is being used can deliver consistently high-quality products. Companies that come under the life sciences must comply with GxP regulations to ensure that their processes meet the regulatory guidelines to be GxP compliant. Computer Systems Validation is the method of ensuring that all computer systems used that go into the production of products in the life sciences industry comply with set regulations and meet the specifications relating to quality.

For the FDA, CSV is more than just hardware and software. It also includes any instruments that are linked to the computer system or are part of it, as well as staff that operate the computer system under set SOPs. The FDA considers GxP as being much broader, as it includes static and dynamic testing.

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Testing and verifying of computerized systems is a crucial aspect of GxP systems. It is a means for showing that a computer system meets the intended requirements. Carrying out testing properly and appropriately is a major regulatory expectation, whose scope and nature have been defined by many regulations from the FDA, the EU’s GMP Annex 11 and other documents.

So, any regulated company has to demonstrate compliance with GxP regulations and show how fit these products are for their intended use. The criterion for the effectiveness of testing is its ability to show compliance with regulatory requirements. This is a means to ensuring the following:

  • Patient safety
  • Product quality
  • Data integrity as a result of controlling identified risks.

The guarantee that systems perform as intended for their use shortens the overall lifecycle of implementing and operating the system. It also prevents delays to the use of the system that could have happened because of the time taken to make corrections to the system.

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At the other end, not carrying out testing adequately or appropriately could result in issues that could surface later on in the lifecycle. Detecting and fixing them at that point is very expensive, cumbersome and very time consuming. Not only do such systems fail to meet intended requirements; they also incur exorbitant costs into corrections, maintenance and support.

Not only these; not adequately and appropriately carrying out test functions adversely impacts in any or all of these:

  • Patient safety
  • Product quality
  • Data integrity
  • Regulatory compliance requirements
  • Ability to meet intended use of the system.
  • Stringent actions from the regulatory agencies, which could include citations and other penalties
  • The business bottom line and the company’s credibility.

A thorough guidance session

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As can be seen from all these; testing of the GxP systems is an area in which no company can afford to be lax. The means of doing this in the right manner that meets the regulatory expectations and help avoid all of the undesirable effects listed above will be taught at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

Angela Bazigos, a seasoned executive with 40 years of experience in the life sciences & healthcare industries, who is CEO, Touchstone Technologies Silicon Valley, will be the Director at this seminar. Please log on to Testing GxP system that is FDA-compliant to enroll for this seminar and gain from the experience that Angela brings into life sciences. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All areas and aspects of GxP testing

The various GxP testing methods and their varieties should be based on risk, complexity and novelty of the software. The aim is to confirm that system specifications have been met. The company may have to carry out multiple stages of review and testing depending on the type of system, the development method applied and the use of computerized system. The testing being of such a complex nature; companies should have the ability to justify the method chosen and the sufficiency of their testing approach.

The use of a scientific Quality Management System such as ICH Q9 to determine the appropriate level of verification and documentation goes a long way in making the testing process effective.  Demonstrating that all required risk controls are in place is one of the purposes of designing tests. Whenever changes are proposed to the system, they should be followed by an impact analysis to determine the extent of any reverification, including any regression testing required. These changes to the system should be made only in accordance with a predefined change control procedure, which should include provision for proposing, approving and/or backing out of the change.

Angela will explain all these in detail at this session. In the process of this explanation, she will cover the following areas:

  • How does testing fit into GaMP5 lifecycle?
  • Risk based methodology for testing
  • How do I leverage supplier testing?
  • What should I test?
  • How much testing is enough?
  • How should I conduct the tests?
  • How should I document my testing?
  • How do I maintain the testing integrity of my system?
  • Testing related 483s and Warning Letters
  • Case Studies.

 

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