Category : Uncategorized

image_pdfimage_print
Screen Shot 2018-08-14 at 2.07.04 PM

Back to School, Back to Health Tips for a Healthy School Year

Back to School, Back to Health Tips for a Healthy School Year

By Jodi Fletcher

Summer is almost over and that means kids will be going back to school. Healthy kids are happy kids. There are some ways to ensure kids go back to school healthy and happy.

Yearly physical

Other than the occasional cold or flu, children don’t visit the doctor’s office often. A yearly physical examination enables the doctor to assess a child’s overall health. Back to school time is a perfect time to schedule these important screenings. The doctor will address important developmental concerns. They will also check the child’s heart and lungs. They may suggest nutritional and physical activity plans, as well as offering advice for children entering adolescence.

Nutrition

Since kids spend six to eight hours at school, what they are eating is important. According to the American Academy of Pediatrics (AAP), children consume 35% to 40% of their daily calories during the school day. Starting the day with a nutritious breakfast that includes protein can help a child focus better on their school activities. Some schools do provide breakfast for students. Not every child likes everything the school’s cafeteria offers. Luckily most schools provide parents with daily menus, so if a child does not like what is offered on a given day, a packed lunch can be planned. Lunches should consist of heart-healthy foods such as fruits and vegetables and lean protein. Foods high in sodium should be avoided. Soft drinks should also be avoided due to the high level of sugar and calories, which increase the risk of obesity, type 2 diabetes, and heart disease. Water, juice, or low-fat dairy products offer a healthier alternative. Schools offer different payment options for lunches, including free lunches to those who qualify. Every child should get enough to eat during their time at school.

Physical activity

Kids do plenty of sitting during the school day. That is why it is important to incorporate some physical activities into their day. According to the Centers for Disease Control and Prevention (CDC), children should participate in a minimum of 60 minutes of physical activity every day. This physical activity decreases the risk of obesity, type 2 diabetes, and heart disease.  Physical activity improves mental health, reducing stress and anxiety. The CDC breaks this recommendation down into three categories.

  • Moderate to vigorous intensity aerobic activity should make up most of the 60 minutes every day, with vigorous intensity activities 3 days per week.
    • On a scale of 0-10, moderate intensity activities are 5-6 and cause the heart to beat faster than normal. Vigorous intensity activities are 7-8 and cause the heart to beat even faster.
  • Muscle strengthening, such as gymnastics or push-ups, at least 3 days per week.
  • Bone strengthening, such as running, at least 3 days per week.

During the school day, children can participate in physical education, recess, and other classroom activities. After school, they can join athletic groups, playgroups, or participate in their favorite physical activity.

Sleep

 For many kids, summer is a time for staying up late and sleeping in. The days are longer and there is so much to do. However, as back to school approaches, kids need to get back into a better sleep schedule. Children who do not get enough sleep have a more difficult time concentrating and learning. Younger children need 10-12 hours of sleep, and getting up on time for school means getting to bed earlier than during the summer. According to the National Sleep Foundation and the Harvard Health Publishing, adolescents who don’t get enough sleep have an increased risk for higher cholesterol levels, higher body mass index, higher blood pressure, and hypertension. Limiting evening activities will help a child shift to use that time to do homework and study. A shift towards a consistent bedtime and wake time should begin at least a week before the start of school. This shift should also include limiting screen time. The AAP recommends that all devices should be removed from a child’s room at night and stop screen time at least one hour before bedtime.

Starting the new school year happy and healthy improves children’s ability to focus and learn. For more information about how to help with a child’s first day back to school go here.

WHAT SHOULD MONEY BUY? THE ETHICS OF ORGANS FOR SALE.

By Jodi Fletcher

How is value calculated? Webster Dictionary defines value as “the monetary worth of something” or “a fair return or equivalent in goods, services, or money for something exchanged” Should everything have a monetary worth? When it comes to how much a living organ is worth, there are factors that need to be considered. Is the organ worth more to the recipient, or to the donor? This is an ethical question that is hard to answer, but is a question in debate. 

There are multiple ethical facets to organ donation:

  1. First, do no harm:
    1. The donor has no medical need for surgery.
    2. There is a risk/benefit balance that needs to be considered. The organ recipient reaps disproportionate benefits compared to the donor.
  2. Informed consent: (for more information on informed consent go here)
    1. The donor must be competent and capable of understanding the risks involved.
    2. Must do so without any form of coercion.
  3. Regarding the question of financial compensation, vulnerable populations must be considered where a donor may lack the capacity to make an autonomous, voluntary decision to agree to donate an organ.

There is a shortage of organs for patients in need of transplants. According to U.S. Department of Health & Human Services there is a continuing decline in available donors. There is a question on how to obtain more organ donations. Proponents for selling organs are suggesting suspending or revoking the prohibitions of the National Organ Transplant Act of 1984 (NOTA). National Organ Transplant Act prohibits the sale of organs based on the idea of valuable consideration. According to the NOTA “The term “valuable consideration” does not include the reasonable payments associated with the removal, transplantation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of human organ in connection with the donation of the organ”. Current arguments for and against the selling of organs consider and evaluate several ethical questions.

Current arguments in favor of financial compensation for organs:

  1. Because demand for organs outpaces supply, it is believed that donation rates would increase if financial incentives were permitted.
  2. Organ donors are the only participants that receive no tangible benefits.
  3. Polls indicate societal support of compensation.
  4. Legal compensation of semen, hair, and plasma suggests the right of a person to use body parts as they wish.

Current arguments against compensation for organs:

  1. Potential abuse of vulnerable populations, such as those in a lower socioeconomic bracket.
  2. Reduction of altruistic donors who feel that compensation weakens their donations.
  3. Reduced donor disclosure due to motives based on compensation rather than altruism.
  4. Financial neutrality is a more ethical alternative.

For living organ donations such as kidney and liver transplants, the costs can add up for the donor. Travel, housing, and lost wages are all expenses that a living donor can incur. According to Warren, et. al.,  donors can incur an average of $6,000 in additional expenses. The goal of financial neutrality or at least the removal of “disincentives” is considered a more ethical approach to obtaining more donors.  

Proponents of financial neutrality suggest the coverage of:

  • Direct medical expenses: all pre and post donation costs related to the procedure
  • Direct nonmedical expenses: travel, housing, food, etc.
  • Indirect expenses: recovery time, lost wages

The recipient’s insurance may cover these expenses; however if it does not, there are organizations available to help. The National Living Donor Assistance Center (NLDAC) works to lessen the financial burden on donors through federal government grant funding.

            Although some countries allow the selling of organs, the theory of supply and demand may not be the best or most ethical motive. There are many other factors to consider.

Let us know your thoughts about the ethics of organ donation in the comments section. We’d love to hear from you!

Thanks for tuning in to the Hart Clinical Consultants Ethics Series!

JUNE IS MEN’S HEALTH MONTH – WEAR BLUE!

By Jodi Fletcher

Summer is a great time to ramp up those New Year’s health goals. The good weather and longer days don’t leave any room for excuses not to get healthy. The month of June has not only Father’s Day in it, but is dedicated as Men’s Health Month. That means time for men of all ages to take a closer look at their health. According to Menshealthmonth.org, the purpose of this month is “to heighten the awareness of preventable health problems and encourage early detection and treatment of disease among men and boys.” Federal, state, and local governments have declared the month of June as Men’s Health Month: to see your state’s proclamation go here. Awareness programs, activities, social media attention, and Men’s Health Week are just a few of the methods designed to encourage men to seek out information about their health. Family involvement is also an important factor in ensuring the men in our lives get the help they need towards longer, healthier lives.        

            Men’s health facts:

  • On average, men live 5 years less than women
  • 1 in 2 will develop cancer
  • Men have a higher death rate than women for most leading causes
  • Approximately 30,000 men in the U.S die yearly from prostate cancer
  • Men see the doctor half as much as women for preventative care
  • More men are uninsured than women

Common men’s health issues are managing chronic diseases such as diabetes, obesity, hypertension, heart disease, and high cholesterol. Other issues that affect health and quality of life are low testosterone and depression. Low testosterone affects sexual health, mood, memory, and energy. Low testosterone increases the risk of other chronic conditions as well. Prostate health problems are common in men, especially over the age of 50, although younger men can experience problems too. 

Prostate health issues:

  • BHP: benign prostatic hyperplasia is an enlarged prostate
    • Not cancerous
    • Most common in men over 50
    • Half of men age 50-60 and 90% by age 80
    • Causes discomfort and frequent, difficult urination
  • Prostate cancer
    • Most common
    • 2nd leading cancer resulting in death
    • No known prevention
  • Prostatitis
    • Inflammation possibly caused by infection
    • Most common in men under age 50

The American Cancer Society recommends that men with average risk factors for prostate cancer get regular screening at age 50. Risk factors include age, race/ethnicity, geography, family history and genetic mutations. Early detection is crucial for treatment. There are two main screening tests used for early detection. One is a blood test that determines the prostate-specific antigen (PSA) levels. The other test is a digital rectal exam (DRE) that checks the prostate.

Steps to improve health and stay healthy:

  • Eat healthy, include fruits and vegetables, and limit salt, sugar, and alcohol.
  • Participate in at least 2.5 hours of physical activity every week.
  • Quit smoking, for more information go here.
  • Reduce stress, try meditation or yoga.
  • Get regular checkups and preventative tests and screenings.
  • Know the signs and get help:
    • Heart attack: chest pain, weakness, pain in the arm/shoulder or neck/back, shortness of breath
    • Depression: sadness, grumpiness, hopelessness, fatigue, thoughts of suicide

Friday June, 15th is “Wear Blue Day” as a reminder of the importance of men’s health, but any day can be designated for group awareness building activities. Wear something blue to show your support, plan events, or create a fundraiser.   

Although the month of June is dedicated to men’s health, its message is important for the whole year. Join us in learning more about men’s health this month by going here  for more information.

Thanks for tuning in to Hart’s Healthy Tips!

conference

HCC NEWS: THE VERMONT CARDIAC NETWORK CONFERENCE

HCC NEWS: THE VERMONT CARDIAC NETWORK CONFERENCE

On September 28, 2017, HCC staff members Cheryl Calhoun and Stan Reaves attended the Vermont Cardiac Network (VCN) Conference held in picturesque Woodstock, Vermont. VCN was established in 1984 to assure cardiac health status of Vermonters and other nearby residents. It is a group of physicians and nurses committed to providing quality educational programs in cardiac care and networking for the healthcare communities within Vermont and western New Hampshire.  More information can be found about the organization here.  VCN holds three conferences each year and this year approximately 100 people attended this Fall conference.

Stan Reaves presented “Late-Breaking Cardiac Clinical Trials Update” to the group. Stan presented introductory materials on the evolution of clinical trials, emphasizing the key elements of patient safety, informed consent, and ethics.  By illustrating mistakes made in the past, he drove home the message of safety and ethics; capitalizing on the importance of patient advocacy in all that we do.  Stan also reviewed recent drug and device clinical trials relative to cardiac care with the premise of using clinical trials to “build a better pump, better pipes, or better valves”.

Stan’s presentation was well-received by the group, garnering positive comments on the evaluation form, such as:

As a result of this presentation, …

  • I will look into nursing research as a career; better understanding of symptom control, and when to make referrals.
  • I will be more careful to spend extra time with patients describing procedures to ensure they make informed decisions, i.e., consents. 
  • I will better walk patients through explanation of the informed consent process.

Other presentations included:

“Sleep Disorders and the Impact on the Heart” by David Alsobrook, MD (North Country Hospital, Newport VT), which addressed the normal sleep cycle, where in the cycle certain sleep disorders interfere, and the structural changes that occur in the heart and circulatory system as a result of prolonged periods of increased intrathoracic pressures and hypoxia.

“The Structural Heart Journey-Learning to walk, to running the Marathon” by Faye Straight RN, BSN CRCC (University of Vermont Medical Center, Burlington VT), which presented the evolution of the Structural Heart Program at UVMC, from their start with the Medtronic CoreValve Evolut R trial for high risk (high STS scores) aortic stenosis subjects to their current program on target to treat 200 patients with severe aortic stenosis by Transcatheter Aortic Valve replacement (TAVR) this year.

Hats off to VCN for their fabulous work for the people of Vermont and New Hampshire!  Check them out here.

Many thanks to Chery, who has served on VCN’s Board of Directors since 2012, and who provided excellent feedback on the conference for this post, and to Stan Reaves who gave an engaging and informative talk at this year’s Fall VCN Conference.

Hart_MAP_Locations-r2

Our CRAs are located across the US, allowing for regional coverage of your project

banner1

Experience managing all phases of clinical trials

banner3

Extensive on-site monitoring experience using a variety of data collection processes

shutterstock_73949041

Experts at implementing FDA GCP regulations and ICH guidelines for clinical trials

banner4

Cath lab professionals with extensive proctoring experience…HCC works with you

Essential documents Deep Dive: Agreements

Good Clinical Practice glossary series

Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents that are typically generated before the clinical phase of the trial begins. We have looked specifically at the Investigator brochure,  clinical protocol/protocol amendments, informed consent tracking,  and the use of advertisements.  Today we will be reviewing financial documents and insurance required prior to beginning a clinical trial.

The Good Clinical Practice (GCP)  guideline, ICH E6 R2, doesn’t go into great detail regarding how financial agreement should be arranged, but it does state that it should be addressed.  The guideline states that financial aspects of a trial should be documented in an agreement between the sponsor and the investigator or institution (page 19), and defines a contract as a “written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters” (page 3).

Many research institutions have checklists for what should be included in a contract between a study sponsor and the institution.  Things that may be required to address in your agreements yet may be overlooked include:

  • Agreement that procedures will be used to protect research participants
  • Dissemination of findings—roles that investigators and sponsors will play in publications, presentations, or other disclosure of results to the medical community, regulatory bodies, and patients
  • Responsibility for medical care for research-related injuries
  • Agreements for sponsor reporting of safety issues to the institution
  • Handling of intellectual property
  • Indemnification or insurance

If required by the applicable regulatory requirements, the sponsor should provide insurance or should indemnify the investigator or institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence (page25). In years past, it was virtually unheard of for sponsors in the United States to be required to purchase this type of insurance for U.S. -located studies. However, in recent years, the trend is growing for large institutions to require such a policy.

Generally, it is good business practice to have written agreements for each area that could be of value to the parties, such as intellectual property, for each area of potential liability, such as payments for research-related injuries, and for potential areas of disagreement, like dissemination of information.  It is no different for a clinical trial and the ICH E6 R2 GCP guidelines speak to the importance of having these documents in place without dictating exactly how they should be implemented.

Thank you for reading HCC’s glossary series!

unnamed-2

Local Athlete Donates $2,000 to Operation Homefront

San Antonio (March 9, 2016) – Ben Blaylock, clinical research associate (CRA) for Hart Clinical Consultants (HCC) – a national clinical research organization (CRO) – donated $2,000 to Operation Homefront this week, a local charity providing emergency assistance to service members’ families and wounded vets. Ben received this money as a prize for earning first place in the “Hart Healthy Challenge,” an initiative by HCC during Heart Month (February) to support healthy lifestyles and give back to the communities HCC serves. Using Jawbone UP24 devices to track their steps, the team members attempted to reach and surpass daily step goals.

“The charity is near and dear to my heart, since many of my family members currently serve or have served in the military,” said Ben.

The competition not only gave Ben the opportunity to give back to his local community, but it also helped him achieve a personal goal of training for the “Alamo 13.1 Half Series” – a San Antonio half-marathon scheduled for March. Between training for the half-marathon and aiming to win the Hart Healthy Challenge, Ben lost 20 pounds in just a few weeks.

“This wouldn’t have happened without the challenge,” Ben said. “Seeing the rest of the team’s activity motivated me to surpass the step goal every day. All the walking strengthened my legs, making a huge difference in my training.”

HCC takes a personal interest in their staff and was thrilled when the team achieved a total of 3.4 million steps together. According to a study released in June 2015 by the Society for Human Resource Management, 70 percent of U.S. employers now offer some kind of employee wellness program. The trend of walking-based challenges like the “Hart Healthy Challenge” will continue to be popular in 2016, and HCC plans to organize another competition later this year.

“Everyone won something this past month by increasing their daily steps and fitness goals,” said HCC Chief Executive Officer Jim Hart. “We value the health and happiness of our employees. It was amazing to see how the competition sparked their motivation and excitement. We hope we inspired other companies to do the same.”

To learn more about HCC’s national team of medical professionals and innovative services, visit www.hartclinicalconsultants.com

# # #

About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive clinical research organization (CRO), providing staff augmentation and leadership throughout all phases of medical device and pharma/IND clinical trials. HCC has an industry leading staff of senior clinical research consultants and specialists across the country that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Juventas, CardioDx and Integrium. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com.