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Clinical Research

Clinical research is a systematic approach to finding out what clinical approaches do and do not work and then using this gained knowledge in to advance and improve clinical decision making. There are many kinds of research, but in the US, about 59% of research focuses on drug research. At any one point in time the FDA has approximately 9-11 thousand clinical trials registered and these trials are seeking 2.8- 3 million subjects. Clinical trial investigative work is conducted in every disease state. Currently, a great deal of research is ongoing in cancer, cardiovascular, Neurology, and anti-infectives.

Bringing a drug to market in the US is a long (10-15 years) and expensive endeavor as about 90% of drug trials do not make it past the first phase of clinical trials. High quality results, timeliness and actionable evidence remain key indicators for a clinical trial. There are four phases of drug trials. Phase I involves safety testing in small numbers of patients. Phase II tests the drug in larger patient populations who have conditions or diseases the drug is meant to treat. Phase III is a pre-approval round where large populations of subjects with affiliated health issues test the new drug as compared to standard treatment. Roughly, 2/3 of Phase III clinical trials are approved by the FDA. Phase IV trials are post- FDA approval trials to explore additional adverse events, performance vs. competitive drugs and additional possible uses.

Patients often enroll in clinical trials with the belief that their experience may be of benefit to future patients. Clinical trial management is highly regulated with involvement and monitoring from many agencies. Informed consent is required. Most consumers and clinicians think of clinical trial research as being performed in large academic medical centers. However, there are many community level models that are available to extend participation and the quality of the research across populations as we are finding that drug response may vary more than previously expected due to each person’s unique pharmacogenomics.

Tune in to this segment to learn about clinical trial research in general and for more information about unique and highly successful community based models of research occurring in GA and the Southeast. Dr. Jeff Kingsley, a clinical research veteran at the national level and his associates will lend their expertise in the field of drug clinical trial research. Listeners can also obtain more information on www.serrg.com and the FDA’s research site at www.clinicaltrials.gov.

 

Dr. Jeff Kingsley

  • Medical training at Philadelphia College of Osteopathic Medicine
  • Completed residency in Family Practice at Columbus Regional Medical Ctr
  • MBA from Emory University
  • CEO/Founder of Southeastern Regional Research Group

 

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Winter Allergies Triggers and Treatment

The CDC reports that over 50 million Americans suffer annually from allergies and that globally, the number of people that suffer from allergies is on the rise. They estimate that in the US, over $18 billion is spent annually on allergy related health care. Although, it may not seem that allergies are a serious problem at first blush, allergy problems can greatly affect quality of life in terms of sleep, work and school productivity and even the quality of our relationships. The same allergens that trigger a response in the spring’s high allergy season – pet dander, mold and mildew, can be intensified with increased exposure as we move indoors during the winter months. Colds are also common during winter months , but many people do not know how to distinguish between a cold flare and allergies. Climate changes can also affect allergic responses.

The most common signs and symptoms of allergies during this time of year include sniffling, sneezing, watery eyes and nasal congestion. Treatments include avoidance of allergens, lifestyle changes and both over the counter and prescribed medications. Desensitization treatments are also now an option that saves time over the long run. In this segment, Dr. David Redding, a board certified allergist, who has been featured on The Weather Channel and TLC will join us to discuss the triggers and treatments of winter allergies. Listeners can also obtain more information on www.reddingallergyatl.com and www.cdc.gov/niosh/topics/asthma.

 

Dr. David Redding

  • MD training at Medical College of GA in Augusta
  • Double Board-Certified in Internal Medicine and Pediatric and Adult Allergy
  • Residency at University of South Carolina
  • Fellowship completed at University of Texas Medical Branch
  • Featured on The Weather Channel and TLC

 

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Patient Healthcare Literacy and Advocacy

Medicine is not “one size fits all” and medicine involves making decisions- many of them. Traditionally, patients have relied on their health care providers thinking that “the doctor knows best” in the areas of medicine, treatments, procedures, surgery and hospitalizations. However, some of the most important and potentially life altering healthcare decisions are not the clinicians’ alone to make. Many believe that with shared medical decision making- when the provider brings evidenced based medical expertise and the patient brings their preferences and values, benefits soar such as: a focus on prevention, an increased ability to manage chronic conditions, increased patient satisfaction and decreased costs. Examples of common healthcare decisions include: elder care, end of life decisions, management of chronic back pain, charting a cancer treatment course, elective surgery and maternity care.

Health literacy also is a component of making better healthcare decisions as many providers overestimate the health literacy of their patients. Patient may lack the fundamental tools to understand what is happening in their bodies and what to do about it. They may not have been brought into the decision making by their provider, know how to work within the medical system, understand the right questions to ask or believe they have power to help heal themselves.

In this segment, Dr. Joseph Pinzone, a double board-certified physician who specializes in endocrinology and the provision of care through the concierge model, has written a new book titled, “Fireballs in My Eucharist” (which was a patient’s description of fibroids in her uterus!). He will discuss the book and how patients can get educated, obtain tools to help in their decision making and help better heal themselves and be an active participant in their healthcare. Listeners can visit www.medamai.com and www.informedmedicaldecisions.org for more information.

 

Dr. Joseph Pinzone

  • MD training at NYU in New York
  • Double Board-Certified in Internal Medicine and Endocrinology
  • Private practice in Santa Monica, CA
  • Author of the new book, “Fireballs in My Eucharist”

 

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Diabetes and Eye Disease

November is Diabetes Awareness month. Did you know that diabetic retinopathy is the leading cause of new, irreversible blindness in adults from industrialized nations for people aged 20-74? Globally, 93 million people suffer from Diabetic Retinopathy alone. Four primary eye diseases are linked to diabetes: cataracts, glaucoma, macular edema and the most common- diabetic retinopathy. Duration of diabetes, poor glycemic control and hypertension are the highest risk factors for diabetic eye disease. Diabetes affects the eye in specific ways.

First, high blood sugar can cause swelling in the lens of the eye. This can be a temporary condition. Over time, diabetes damages the tiny blood vessels in the retina and can cause blind spots, blurred and double vision, “flashing lights”, floating spots and decreased vision. Visual acuity can also fluctuate. Decreased vision, however affects daily living. There are four stages of Diabetic Retinopathy and eye exams for diabetics include more specialized test than a routine annual comprehensive eye exam. There are no treatments available to restore lost vision. However, there are treatments that can minimize further damage and aid in coping with the damage including: lasers, medicine, surgery and vision-related rehabilitation.

In this segment and as part of Diabetes Awareness Month, Dr. Janelle Davison, a local optometrist that specializes in clinically complex eye care will provide a general overview of how diabetes affects the eye, diabetic eye diseases, treatments and preventive strategies for diabetic patients to maintain their vision. Listeners can visit: www.brillianteyesmarietta.com, www.visionaware.org or www.diabetes.org for more information.

 

Dr. Janelle Davison

  • BS in Biology from Xavier University in LA
  • Doctor of Optometry from Pennsylvania College of Optometry
  • Specialist in clinically complex eye disease
  • Currently in private practice at Brilliant Eye Vision Center in Marietta, GA

 

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Alzheimer’s Disease

November is National Alzheimer’s Disease Awareness month and unfortunately, the US ranks first in the increasing number of deaths associated with neurological disease, including Alzheimer’s Disease (dementia). Today, over 5.4M Americans suffer from some degree of Alzheimer’s and this number is expected to double between now and 2030. Did you know that Alzheimer’s affects twice as many patients as heart disease and three times as many patients as cancer in the US? Estimated annual expenditures for 2010 for Alzheimer related treatments were $200B. Yet- this disease, for which there is no cure or proven treatments to delay or stop the disease is almost absent from mainstream media-perhaps because there are not many profitable remedies.

Alzheimer’s is a neurological disease that disrupts the way electricity passes through our brain and also affects the activity of neurotransmitters in the brain. Over time, the brain, quite literally, shrinks due to nerve cell death. Risk factors for Alzheimer’s include: age, family history, genetics, head trauma and some lifestyle factors. The primary symptoms for Alzheimer’s is memory loss that disrupts daily life (this is different than normal aging memory changes). Diagnosis is made through a complete medical assessment that may include a physical exam, neurological tests, mental status tests, blood work and brain imaging. There are several stages of Alzheimer’s and patients do not all progress at the same rate. There is no cure for Alzheimer’s Disease and no treatments that have proven to delay or stop the progression. Treatments focus on symptom management for sleep disturbances and memory loss.

Most distressing to families of patients with Alzheimer’s are behavior changes such as irritability, depression, anxiety, sleep changes, verbal outbursts and delusions. There are also many “myths” surrounding Alzheimer’s like- do flu shots, aluminum or Aspartame lead to the development of Alzheimer’s? Can only older people get Alzheimer’s?

In this segment, Dr. Monica Parker, a board certified family medicine physician and gerontology specialist and Ms. Suzette Binford, the Program Director of the Atlanta Chapter of the Alzheimer Foundation, will provide a general overview of Alzheimer’s Disease and some tips on “life after a diagnosis of Alzheimer’s Disease. Listeners can visit: www.emoryhealthcare.com and www.alzfdn.org for more information.

 

Dr. Monica Parker

  • MD obtained from University of Nebraska
  • Residency completed at University of Mississippi
  • Board-Certified in Family Medicine, Gerontologist
  • Assistant Professor, Dept. of Medicine, Div. of Geriatric Medicine at Emory University

 

Suzette Binford

  • Master’s Degree in Clinical Counseling from The Citadel
  • Program Director, Alzheimer’s Foundation, ATL Chapter

 

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Specialized Dentistry: Hospital, Special Needs Kids, Dental Trauma

Most of us think of dentistry as routine: teeth cleaning, period Xrays for cavities, fillings and the occasional crown or root canal. However, there is an a very specialized area of dentistry that handles such issues as hospital dentistry, dentistry for special needs children (autism, Down’s Syndrome and developmental delays) and dental trauma. These skilled dentists receive rigorous additional training in oral-maxillofacial surgery. It is rarely thought of until it is needed. Many of these procedures are performed in a hospital setting to care for medically compromised patient or patients with adjunct and compiled medical conditions. They treat patients requiring reconstructive surgery, implants, injuries to the head, face and neck.

Please join us as Dr. Albert Baawo educates us about the world of “specialized” dentistry! Listeners can learn more at www.tooth11.com.

Dr. Albert Baawo (DMD)

  • DMD obtained at Medical College of GA
  • Served as VP of N. GA Dental Society
  • Internship at Emory University (Oral and Maxillofacial Surgery)
  • Private practice in Buckhead

 

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An Overview of Male Infertility

The male role in contraception has been thought of as relatively simple, when in fact, it is actually quite complicated. The Mayo Clinic estimates that 15% of couples are infertile (frequent , unprotected sex of childbearing age with no pregnancy in one year). Research estimates show that 7.5-10% of all males of reproductive age are infertile. Male infertility is a major cause of no conception in 50% of childless couples. Male infertility can be defined as abnormalities in sperm production, maturity or delivery that impedes the establishment of pregnancy.

The male reproductive cycle involves testosterone secretion that is the common link between the pituitary gland and the testes. To achieve a pregnancy from the male component the following is needed: 1) healthy sperm 2) enough sperm is carried to the semen 3) the sperm is correctly shaped for motility and 4) no ejaculation problems. Causes for male infertility include varioceles (swelling of veins that drain the testes-42%), obstruction, infection, chromosome abnormalities, hormone imbalances, tumors, ejaculation problems, anti-sperm antibodies, sperm duct defects, some chronic diseases, environmental causes (exposures) and lifestyle causes (weight, stress, smoking and drug use). Male infertility evaluation often includes a semen analysis, an extensive medical history, a physical exam, lab testing and ultrasound examination.

Treatment of male infertility usually focuses on correction of the underlying problem or using treatments to help with the infertility. Possible treatments include: surgery, medications and assisted reproductive technologies such as sperm retrieval, sperm donation and cryopreservation. The process of identifying and treating male infertility can be stressful for the individual and couple. Costs can be high and this treatment is typically not covered by health insurance. The outcome is often unknown for some time period and stress can be high. There are many coping strategies and support groups for psychosocial support.

In this segment, Dr. Michael Witt, a board certified urologist and male infertility specialist (one of the few in the southeast) will discuss the a general overview of male infertility. Listeners can visit: www.rba-online.com and www.resolve.org for more information.

 

Dr. Michael Witt

  • MD obtained from Oregon Health Science University
  • Completed residency in urology at Boston University Hospital
  • Fellowship in male infertility completed at Baylor College of Medicine in TX
  • Board-certified in urology
  • Featured on CNN, The Learning Channel, named one of Atlanta’s Top Doctors
  • Now in private practice at Reproductive Biology Associates in Atlanta

 

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Year End Planning for Medical Practices

The healthcare environment changes daily and physicians often struggle to keep up with regulatory changes, competition and reimbursement changes. There are many challenges looming: Obamacare, ICD-10 and Meaningful Use. Providers must spend time working on their practices as well as in their Atlanta Business Radio practices to thrive and not just survive. However, practices do not have to stay in a reactive mode. Taking time to plan can put a practice in a proactive mode to be able to anticipate and appropriate respond to opportunities, changes and challenges.

Quarter 4 is the perfect time to take action to minimize tax burden, maximize retirement plans, reconcile inventory, create the coming year’s budget and evaluate the coming year’s capital needs. Taking inventory, updating depreciation schedules, retirement planning, fee schedule analysis, A/R cleanup, tax planning, productivity and compensation evaluation are just some of the year end financial activities that can really make a difference in achieving solid financial performance.

Planning for retention of market share and growth is key to future practice viability yet how many practices have a formal, annual marketing plan. Marketing is often viewed as an expense vs. an investment yet new patients are a critical piece of revenue generation for every practice. The same marketing plans often do not yield different results and how providers reach, communicate with and message to current and potential patients is changing. Year end is a great time to acknowledge referral sources and examine the ROI of existing marketing efforts, brand cohesiveness, content relevancy and process, social media effectiveness and to make adjustments as needed. In a recent poll, 51% of patients said that digital communications would make them feel more valued as a patient and 41% said social media would affect their choice of healthcare providers. Is your practice keeping up with the interactive“new word of mouth” ?

An overall strategic plan can be the differentiating for success. Yet, many providers either don’t know how or feel they don’t need it. Yet, evaluation of Key Performance Indicators (KPI’s) to show the current standing of a practice, a SWOT analysis, a competitive overview and then making and implementing a strategic plan will help all businesses be positioned to recognize and capitalize on growth opportunities, assist in overcoming challenges and help protect market share for any business. Why should the business of medical practices be different?

In this segment of The Doctor’s Roundtable, three industry subject matter experts will weigh in on tips, strategies and considerations for year end planning for 2014 for medical practice success. Join Sharon Allred of LW Consulting ( a healthcare strategic planning expert), Beth McCauley of McCauley Marketing and Mark Estroff, CPA and medical practice tax expert as they share their best advice for positioning your practice for success in 2014. Listeners can visit: www.lw-consulting.com , www.mccauleyadvertising.com and www.pyagatesmoore.com for more information.

 

Mark Estroff

  • CPA, PYA GatesMoore

Beth McCauley

  • Founder, McCauley Marketing Services

Sharon Allred

  • Principal, LW Consulting

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Venous Reflux Disease

Veins have valves to promote sufficient blood return from the lower extremities to the heart. However, when veins in the lower extremities don’t function properly, the blood flows backwards (reflux) and can pool in our legs, ankles and feet. Over time and left untreated, this condition (also called chronic venous insufficiency) can cause spider and varicose veins, swelling, aching, leg cramps, discoloration, restlessness and can lead to venous hypertention. On the mild side, this condition causes veins on the surface that are cosmetic but harmless. On the serious side, it can lead to disability and venous hypertension. Both sexes can be affected by this condition, but women appear to more affected than men. It can also have genetic implications. Gravity, standing on your feet for long periods of time and sedentary lifestyles can exacerbate the conditions. It is a global problem with serious health and economic implications. Approx. 10% of the population or roughly 40 million Americans are reported to have some form of venous reflux disease.

Old treatment of venous reflux disease often involved surgery and saphenous vein “stripping.” With the advent of lasers and imaging technology to measure valve function, newer treatments are often non-invasive and employ thermal energy or injections. Conservative treatments involve compression stockings and lifestyle changes (weight loss, feet elevation, increasing movement). Newer and promising treatments on the horizon include genetic links (Restless Leg Syndrome) and nutraceuticals.

In this segment, Dr. Darelll Caudill, a board certified cardiovascular surgeon and Medical Director of VeinInnovations and his team will discuss the venous reflux disease spectrum, diagnosis, signs and symptoms and treatments. Listeners can visit: www.veininnovations.com, www.rls.org and www.phlebology.com for more information.

 

Darrell Caudill, MD, FACS

David Martin, CRNFA

Frank Ferrier, MD, FACS

Alexander Park, MD, FACS

David Park, MD, FACS

 

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Pediatric Food Allergies

Approximately 15 million people have food allergies and about 6 million of them are children. Food allergy occurs when the body’s immune system identifies a specific food as a foreign substance and produces an allergy antibody (IgE) to respond to the substance. Compounding this response is the fact that the most common foods people are allergic to, such as peanut, wheat, soy, eggs are frequently in our diet! Food allergies can be mild to severe and in rare cases, life threatening if they stimulate an anaphylactic reaction.

There are two types of food allergies: fixed (immediate response) and cyclic (delayed). Signs and symptoms of food allergies include: itching in mouth, swelling, GI symptoms (vomiting and diarrhea), hives, tightness in the throat and difficulty breathing. Food allergies should be distinguished from intolerances and sensitivities to food (non immune reactions). Diagnosis may involve: extensive history, nutrition evaluation, lab testing, food challenges, elimination diets and skin testing. Food allergies can also be connected to other allergies. There is no known curative treatment for food allergies at present but treatment involves: strict elimination, education (food labels, meal prep, high risk situation avoidance), emergency planning and availability of emergency medications. There is promising new research in this field- sublingual immunotherapy.

In this segment, Dr. Lakshmi Reddy, a local Atlanta physician that is board certified in adult and pediatric allergy, immunology and asthma will discuss the basics of pediatric food allergy signs/symptoms, diagnosis and treatment. Listeners can visit: www.reddyallergy.com and www.aaaai.org for more information.

Dr. Lakshmi Reddy

  • Medical School at Meharry Medical College
  • Residency completed at Washington University in St. Louis
  • Fellowship in Allergy and Immunology at Medical College of GA
  • Board certified in allergy, immunology and asthma
  • In private practice in Johns Creek, GA

 

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