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!




May is Global Employee Health and Fitness Month

Whether you punch a time clock or work from home, your health is important to your workplace productivity and happiness. May is Global Employee Health and Fitness Awareness Month (GEHFM).  According to the GEHFM and Health.gov, the goal of this month’s awareness program is to “to promote the benefits of a healthy lifestyle to employers and their employees through worksite health promotion activities and environments”.  Throughout this month there are programs designed to help employers and employees improve their health.

The success of these programs depends on the support and dedication that comes from the employers and executive leaders. According to Health.gov, when executive leadership creates a culture of physical activity, employees are more likely to participate in wellness programs, and become more active. The National Coalition for Promoting Physical Activity (NCPPA) has developed a CEO pledge for executive leaders to utilize as an effort to establish a culture of health and wellness.

Benefits of the CEO Pledge are:

  • Employees will be healthier
  • Employees will be happier and more engaged
  • The organization will increase productivity
  • The organization will be better positioned to recruit and retain top talent
  • The organization will be publicly recognized as a forward-thinking employer and thought leader

The pledge calls for CEOs to implement at least six strategies that fall within three categories. These categories consist of policies that address behavioral, educational, and environmental/policy support.

  • Behavioral Support
    • “Healthy meetings” which involve walking, stretching, or other physical activity during the meeting
    • Inspirational programs such as recognition/rewards and individual or team competitions
    • Buddy systems
    • Sponsored walk/run events
  • Educational Support
    • Provide information
    • Invite speakers
    • Promote benefits of getting up and moving often
  • Environmental/Policy Support
    • Provide fitness classes onsite
    • Offer reimbursement/incentives for exercise expenses
    • Bike share discounts
    • Longer break time
    • Provide areas that support physical activity, such as showers, bike racks, clean and safe stairways, onsite fitness areas, walking paths, and “active office” furniture.
    • Allow work out friendly attire
    • Brief activity breaks

Once an organization’s health and wellness goals are established, there are great desk and office stretching exercises and activities that can help promote a healthy workplace.  Standing desks are becoming more popular in the workplace. This desk allows either sitting or standing to work at a computer or flat surface. Sitting for long periods of time without standing, stretching, or moving is unhealthy and contributes to a sedentary lifestyle.

Long hours of sitting are linked with a higher risk of:

  • Obesity
  • Diabetes
  • Cardiovascular disease
  • Cancer
  • Premature death

There are many benefits to a standing desk:

  • Comfort: standing can alleviate pressure on back, neck, and legs
  • Improved focus
  • Collaboration: it is easier for two people to view the computer
  • Versatility: divide time between standing and sitting

Whether you are an employer or an employee, it is important to have a happy, healthy work environment. Encourage executives and co-workers to implement and utilize physical activity and wellness programs in your workplace. May is the time to start during Global Employee Health and Fitness Month.  




CLINICAL QUALITY ANNOUNCEMENT: DAN BECK IS PROMOTED TO DIRECTOR OF CLINICAL QUALITY

HCC Staff update

We are very excited to announce the creation of the Director of Clinical Quality Assurance (CQA) position here at HCC and the promotion of Mr. Dan Beck into that role.  Jim Hart, President and CEO of HCC, says this of the expansion,” I am very excited to have Dan lead HCC’s Clinical Quality team.   Dan has an impressive resume of study monitoring and auditing that supports his understanding of industry regulations and compliance.   Along with this expertise, he possesses exceptional interpersonal and communication skills, which are critical to implementation and execution of quality methods and operations.”

Dan joined HCC in 2016 after serving in clinical director roles for three different medical device companies, including Advanced Stent Technologies, Inc. Thoratec Corporation, and KeraVision, Inc. Early in his career Dan worked as a CVT technician in the cardiovascular lab at St. John’s Regional Health Center in Springfield, MO.  In addition to his clinical and clinical research background, Dan brings experience from multi-functional areas of regulatory, manufacturing, R & D, and quality assurance.

This newly created position will encompass oversight of HCC’s clinical quality management system and will bring added resources to the already effective HCC Clinical Quality team.  The Director will work hand-in-hand with HCC colleagues to support clinical quality across all service areas. Per ICH-GCP E6(R2), clinical quality assurance must be an integral part of any clinical project; the Director of CQA position aligns with the current landscape to ensure that quality assurance and control provisions are paramount for HCC clients’ clinical projects.

Mr. Beck said this about the expansion of clinical quality at HCC, “I am personally excited about this role because it provides me with an opportunity to enhance the quality services of an already high-quality team, where I can apply nearly three decades of clinical research experience to a growing, dynamic company. As part of the wider HCC team, it is rewarding to contribute to the delivery of clinical quality assurance to our clients”.

 HCC’s goal is to provide the highest level of service to our clients – based on HCC people – supported by HCC systems. We at HCC strive to sustain peace-of-mind for our customers in their decision to join with Hart Clinical Consultants. Peace-of-mind knowing they can consistently expect, and receive, high-level performance with high quality assurance…

…across all pillars of service.

We are blessed to have Dan as part of our HCC family. Please help us congratulate him on his new role as Director of CQA.




STAFF SPOTLIGHT: BEN DOWN UNDER

Staff Spotlight:  Ben Down Under

By Ben Blaylock

All photos copyrighted Ben Blaylock, © 2017 Ben Blaylock.

On December 9, 2017, I left San Antonio, Texas, for a work trip to New Zealand.  Once the work was done, I tagged an additional 10 days on to my trip, rented a car, and set out on an adventure. Over those 10 days, I drove 3088 km, or 1918 miles exploring the North and South islands. That’s 200 miles further than San Antonio to San Francisco!!  This country has some of the most breathtaking scenery in the world… it was a truly memorable experience I won’t soon forget.

New Zealand

My formal destination was Tauranga, NZ, where I was set to monitor data for one of the trials we are working on at HCC. 

It took two days to get there–all in all close to 30 hours of travel time.  After a one-night layover in Brisbane, AU on December 10th, I arrived in Auckland, NZ on the afternoon of Monday, Dec 11th. It was then another 2.5hr drive from Auckland to Tauranga.

I worked from Tuesday through Thursday, Dec 12-14th, and had from Dec 15 – 24th of personal time to get out and explore.  Most of the trip was spent in NZ (10 days, Dec 11 – 21).   Our winter is their summer, so long daylight hours meant I could get out and explore after work until about 9 pm or so when the sun went down, so even though I had to work the first 3 days, there was plenty to explore in and around Tauranga until I was officially done with work on the afternoon of Thursday, Dec 14th.

I did a sea kayaking trip to Cathedral Cove, NZ.  They say it’s the most photographed spot in New Zealand and is the shooting location of the Prince Caspian Narnia movie.

Visited the Hobbiton movie set in Waikato NZ, filming location for the Lord of the Rings film trilogy and The Hobbit film series.  The Shire was truly spectacular. It’s like walking into Middle Earth… they have over 14 acres dedicated to the movie set alone, with 40 hobbit houses, each unique, meticulously decorated, and designed to reflect life and personality of the hobbit that lives there. So much detail…… just like out of the movies.

Went spelunking in the Waitomo caves in Waitomo, NZ, which is about 2 hours southwest of Tauranga,

One of my travel days was 17 hours long, which surprisingly, was one of the highlights of the trip.  On this particular day, I woke up at 4 am in Wellington, NZ and took a 3-hour car ferry across the Cook Strait from the North to the South Island to Picton, NZ.  From there I drove 10 hours southwest to Mount Cook, the tallest point in New Zealand. On the way, I saw beautiful flora. These are Lupine beside a creek near Mount Cook, NZ.

Mount Cook and Tasman Lake, nestled in the Southern Alps

Mount Cook is an international dark-sky reserve and has some of the darkest skies on the planet… and I had an observatory tour and time with the telescope booked that night.  Before making the drive, I learned they had canceled the night sky tour the last 5 nights in a row because of cloudy weather. They couldn’t make any promises that the tour would happen that night, but I had to try… Turns out it was a beautiful, clear night, the tour was on, and the sky was spectacular!!  Even with a few clouds, you could see the stars right through them, the sky is so dark there. Here’s some of what I saw through the telescope:

  • Seven Sisters (Pleiades) open star cluster
  • Five diamonds – star cluster. Had a couple of Red giants! 
  • Orion Nebula – beautiful! No clouds over Orion, very clear and sharp
  • 47 Tucanae – oldest star system – 11 billion years old – through a telescope just a  cluster. So beautiful!!
  • Small Magellanic cloud- 200 million light years away
  • Large Magellanic Cloud – 160 million light years. 3rd closest galaxy to the Milky Way. It contains tarantula nebula, we looked at it through the telescope 
  • and of course: the Geminid meteor shower!! It was mostly over, but because it was so dark there, I saw a good dozen or so shooting stars over Gemini… so bright!! No telescope needed.

Such a rare treat to see a part of the sky we just don’t see on this side of the world…. The southern cross wasn’t visible through the telescope, but I stayed up late until it crested just above the mountains about 1 am… and with the sky so bright, it was a sight to see.  

Australia

It’s not often I’m on this side of the planet, so the last three days of my trip I took the opportunity to visit Cairns, Australia and check off a bucket list item: dive the Great Barrier Reef.  It was my first dive ever, and I’m sure I’ve spoiled diving forever.  The water was crystal blue, the coral was alive and vibrant, and the sea creatures bigger than life.  Well worth the trip!

Found Nemo

School of Bumphead Parrotfish.  Each of these massive fish was about the size of a small human

I ended my trip in Sydney, Australia for one last look at the Southern sky 

Sunset from the Sydney Observatory

One of the biggest challenges driving in New Zealand was roundabouts! Just when I got comfortable driving on the left side of the road, I’d come to one, and usually got the horn from other drivers, or have to jam on my brakes to avoid a catastrophe. That definitely kept me alert and on my toes!  

The odd thing about driving on the left side of the road, though, was that for the first few days, I had to keep telling myself over and over, “Keep left, keep left, keep left.” There was even a big sticker on the dash that said those words in big bold red letters, which helped.  But after a week or so, driving on the left started to really make sense… we read from left to right, right?  When we’re scanning the horizon, our eyes naturally start on the left… so driving on the left started to really make sense.  So much so that when I got home, driving on the right felt weird, unnatural even. Thankfully, I quickly adapted back to driving on the right, but I still think about that sometimes and how we may be the ones who are driving on the “wrong” side of the road….

Tips for travelers

CRA work provides an amazing opportunity to get out and see the world. Even when I take trips in the US, I always try to make time to leave the hotel room and see what’s around.  Sometimes that means arriving earlier in the day or staying an extra day to see some sights.  

Tip #1: Stay at hostels when extending a work trip or traveling for fun. They’re usually situated right in the action, within walking distance to major sights and activity, bus/rail lines, etc.  Many hostels are in older historic buildings as well, with a great history.  Hostels are also much better than hotels for getting the low-down on walking tours in your area, sights to see, talking to fellow travelers, etc.  In addition to shared rooms for really cheap, most hostels have private rooms available as well, for much cheaper than a hotel.

Tip #2: For extended trips, mail your souvenirs or gifts home, rather than lugging them around your entire trip.  It’s a great way to lighten your load–and make room for more stuff!

I’m so excited and grateful for the chance to explore Australia and New Zealand and that my role with HCC provides diverse opportunities around the world. 

As always, thanks for tuning into the HCC blog!! 

 




ESSENTIAL DOCUMENTS DEEP DIVE: MONITORING REPORTS

Essential documents Deep Dive:  Monitoring Reports

Hart’s 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,  advertisements, and agreements.  Now we will look at some key documents required once a clinical trial begins. Our first installment in this phase will be on monitoring reports.

To learn more about the monitoring process go here.  The Good Clinical Practice (GCP)  guideline, ICH E6 R2, defines a monitoring report as “A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs”.

The monitoring report should document a study’s progress and compliance with GCP guidelines, and should record any problems at the site, including both minor and major items.  Minor findings may be documents with errors or that need to be filed in the study trial file, while major findings could include findings related to safety or informed consent. In either case, the report documents the initial finding and tracks resolution of each finding.

The written monitoring report should be submitted to the sponsor after each trial site visit and should include, at a minimum:

  • Date of visit
  • Name of monitor
  • Name of the site and investigator or other personnel
  • A summary of what was reviewed, including statements regarding:
    • significant findings/facts
    • deviations/deficiencies
    • conclusions
    • actions taken or recommended to be taken

A sponsor representative should review and follow-up with any outstanding actions documented in the report, and reports should be signed by the sponsor as final once complete.

GCP indicates that “results of monitoring activities should be documented in sufficient detail to allow verification of compliance with the monitoring plan”, which is a plan for how monitoring will be conducted and who is responsible for given monitoring tasks.  

Sufficient detail means that not only should negative findings be reported with enough detail for follow-up and resolution to occur, but also that positive compliance should be detailed. For example, patients for whom the informed consent process was completed satisfactorily should be documented as such, not left blank. Omission of such detail is not an indication of compliance, but is rather a lack of detail that should be included to adequately document compliance.

Monitoring reports are a key tool used in conducting a clinical trial. Sponsors and CROs usually have operating procedures for how monitoring should be conducted and how the reports are to be written.  Some additional sources for monitoring and reports can be found here, here, and here.

Thank you for reading HCC’s glossary series and happy monitoring to you!

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HART’S HEALTHY NEW YEAR TIPS

HART’S HEALTHY NEW YEAR TIPS

By Dana Fletcher and guest author, Jodi Fletcher

Whether you make ‘resolutions’ or not, you can still start the New Year right with a few heart-healthy lifestyle changes.  There is no better time to start making healthy lifestyle choices than right now.

Sometimes, we can feel overwhelmed by the many things we could or should do to improve our health.  To combat that, try picking just ONE thing to change and stick to it. Kirsti Dyer from Columbia College suggests that making simple, reasonable goals is one way to successfully achieve them. 

We challenge you to pick one small thing from the lists below and try to stick to it.

The National Heart, Lung, and Blood Institute suggest heart-healthy lifestyle goals should include heart-healthy eating, physical activity, stress management techniques, healthy weight goals, and quitting smoking.

Many people know they should eat better, exercise more, quit smoking, and take time to relax. But how do we start?   Let’s break it down into simple steps that are achievable by anyone.

Heart-healthy eating:

  • Eat vegetables, fruits, whole grains, low-fat dairy, lean meats, poultry, eggs, nuts, seeds, legumes, soy products. This could mean that if you eat one piece of fruit per week, try to increase that to two or switch from full-fat milk to 2% fat. Keep it simple.
  • Learn what your calorie intake should be based on your sex, age, and activity level (for more information go here).
  • Limit sodium, saturated and trans fats, added sugars, and alcohol. Try drinking a glass of water in between alcoholic beverages to limit intake and the effects of alcohol and to stay hydrated.

Physical activity:

  • Helps with lowering health risks, weight loss and stress management.
  • Consult your doctor. This is one of the first things to do if you haven’t been active previously to know if you have any limitations on your activity levels.
  • A good goal is to shoot for at least 30 minutes per day, 5 days a week. If you haven’t been doing that, start slow. Start with 2 or 3 days a week for 5 minutes and slowly build up your time and days over a period of months.  Take the stairs instead of the elevator or park farther away from the grocery store door.  Take it slow and don’t try to increase too much too soon.  Just try to be a little bit more active each week and it will make an impact.
  • Break up sitting time. If you work at a desk, set an alarm so you get up at least every 30 minutes, get up and walk around, refill your water cup, or even just stretch at your desk.  Experts say you should try to break up sitting with more active tasks.

Stress management techniques:

  • There are many classes, videos and audio meditations readily available. One easy way to start is just to sit for 1-5 minutes and focus on breathing deeply and slowly. You don’t have to sit for an hour in deep contemplation to get benefits from meditation.

  • Physical activity. Activity, especially outside is a great way to de-stress.
  • Relaxation therapy. This could include yoga, creative imagery, breathwork, massage, or many other modalities to help you relax and release stress.
  • Talk it out. Find a friend, family member, counselor, or group to talk through stressful situations.
  • Seek professional help if you can’t reduce your stress on your own.
  • For more information go here

Healthy weight goals:

  • A loss of just 3-5% of current body weight lowers triglycerides and glucose levels.
  • Consult your doctor on any weight loss plan to make sure it is safe and appropriate for you.
  • A good place to start is to review the Body Mass Index (BMI) to find out whether you need to lose weight, but remember, you can have a BMI in the normal range and still be unhealthy if you aren’t active and eating healthy.
  • Healthy eating habits, physical activity, and managing stress are key components of any healthy weight loss plan. Focus on improving those areas of your life, and achieving your weight goals will be much easier.

And of course, quit smoking. 

Most of us know that smoking increases the risk of heart disease. The AHA recommends that people seeking to stop smoking should find professional help in the form of their doctors, support groups, or other counseling services. Quitting is tough, but the first step is finding the support you need to make it happen. They also recommend:

  • Set a quit date
  • Choose your quit method
  • Decide if you will need medicine to help you quit
  • Plan your quit day
  • Do not smoke starting on your quit day
  • For more information go here and here

So, take our challenge and pick one thing to do in January to start down the path to a healthier heart!  Let us know in the comments section what you do!

Happy New Year and have a heart-healthy 2018, and beyond!

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MESSAGE FROM THE PRESIDENT: LOOKING BACK TO LOOK FORWARD

MESSAGE FROM THE PRESIDENT: LOOKING BACK TO LOOK FORWARD

Last year at this time, alongside the visions of sugarplums dancing in my head were thoughts of gratitude. As 2017 has progressed and now comes to a close, I am struck by what those visions have meant for me this year.  Marcus Lemonis, CEO of Camping World, and host of the television show, The Profit, is famous for saying that products and processes can be improved, but that:

“People are the most important thing.”

This is what I’d like to share with you today. In our business, it is truly the people that make all the difference and I am grateful for the people I work with and the relationships HCC has cultivated around the world. Our theme this year was indeed about people and relationships.

In 2017, we added staff to allow for growth of our infrastructure and improvement of our processes. Our team has infused new, fresh ideas to our business and for this, I am so very thankful.  In 2018, we hope to continue to grow and build our capabilities by relying on the talents and skills of the HCC team. By building on our strengths, we will be adding new functionalities to the services we offer.

I often see companies like ours grow at rates that are unsustainable, where growth outpaces the companies’ ability to provide high-quality services. It is our goal for 2018 to continue to grow HCC, but to grow at a deliberate pace such that we can continue to provide the highest quality service, where we continue to strive to do the right things and to do right by our team.  Or, as Ivan Chouinard, CEO of Patagonia, author of Let My People go Surfing: The Education of a Reluctant Businessman and famed climber has said, 

How you climb a mountain is more important than reaching the top.”

 

Wishing you and yours a blessed holiday season, with joy, love, and success in the coming new year

From all of us at HCC

Jim Hart




STAFF SPOTLIGHT – PATTI LAWRENCE IS PROMOTED TO SENIOR CRA

STAFF SPOTLIGHT 

PATTI LAWRENCE IS PROMOTED TO SENIOR CRA

Four years ago, a voice from Patti Lawrence’s past called her cellphone. Jim Hart, Chief Executive Officer of Hart Clinical Consultants, needed someone with clinical experience working in a cardiac cath lab. From that one phone call, Patti began a new phase in her professional career as a Clinical Research Associate, initially filling device proctoring roles, but diligently training as a clinical monitor. For the difference between the two roles, click here.

Since those days in 2013, Patti has worked on nine medical device trials with HCC, as both proctor and monitor. When she first joined HCC, she had very little monitoring experience, so she read everything she could about it while she was mentored by Jim and Stan Reaves, HCC’s Chief Operating Officer. Certification as a Clinical Research Professional (CRP) requires a minimum of two years’ experience in the field. In October of this year, Patti took and passed the SOCRA CRP certification exam.

Please help us congratulate Patti on her earning the CCRP certification and on her recent promotion to Senior Clinical Research Associate. 

Patti’s continued commitment and contributions to HCC, shine through her with her obvious love for her work. According to Stan Reaves, among her many accolades is a vast knowledge of cardiac and vascular anatomy and physiology. This knowledge and many years in the cath lab translates to client appreciation for her ability to teach difficult topics with simplicity, great analogies, and examples that lead to a thorough understanding by the learner. Stan provided this story that exemplifies Patti’s contribution to HCC, “Patti saw a need for education of team members for a stroke intervention trial and put together a presentation to teach the folks working on the project. She has also recently taken on the lead role for a seminal peripheral vascular device study, for which she has developed a strategy for training 40 study sites as part of her responsibility for coordinating site coverage.” A can-do attitude, perseverance, and an aptitude for adapting to most personality profiles enables Patti to develop strong working relationships with even the most demanding individuals for the long game.

Medical Device Executive Eric Knuteson had this to say about working with Patti to support clinical trials at Osprey Medical (Minnetonka, MN), “She exemplifies professionalism beyond reproach and is a calm pro who is able to navigate any customer situation with intuitive approaches to details and challenging requirements. She sacrifices her personal schedule to meet any clinical last-minute need, like booking last-minute travel on a Sunday afternoon.”

Patti says she could not be happier than she is right now working for HCC. “I truly enjoy working with and meeting new people” she says of the job, and enjoys the travel associated with it.  She is planning to use some of the travel perks she’s been collecting to go experience the Aurora Borealis up close by standing underneath, listening to the hissing and crackling of this natural phenomenon.

We are blessed to have Patti as part of our HCC family. Thank you, Patti, for being a key player and for your continued commitment to excellence in all you do!

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Experience managing all phases of clinical trials

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

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

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




HART HEALTHY TIPS: THE GREAT AMERICAN SMOKEOUT

HART HEALTHY TIPS:

THE GREAT AMERICAN SMOKEOUT

Save the date Thursday, November 16th! The American Cancer Society holds a very important event that day, which can be the first day towards quitting smoking for many people.

It’s The Great American Smokeout!

According to the Centers for Disease Control and Prevention, approximately 36.5 million Americans (15.1% of all adults) smoke cigarettes. Smoking causes several life-threatening diseases such as cancer, stroke, lung and heart diseases, diabetes, emphysema, and chronic bronchitis. Over 16 million Americans have diseases caused by smoking. In the United States alone, cigarette smoking causes more than 480,000 deaths per year. The financial costs of smoking are significant with a $300 billion price tag in the United States, and direct medical costs of over $170 billion. Despite these costs, quitting can be difficult.

Many smokers want to quit, but don’t know where to start. According to a government study nearly 70% of adult smokers want to quit, but only 6 % could stop smoking. Withdrawal symptoms such as irritability, anxiety, having trouble focusing, feeling angry, cravings for tobacco products, and weight gain can make it hard to stick to a plan.  If a smoker can make it through these symptoms, the health implications are significant.

                                                                                                   *2015 Centers For Disease Control and Prevention

Health benefits begin within 20 minutes of quitting by lowering heart rate and blood pressure. After 1 year the risk of coronary heart disease is cut in half and after 5 years the risk of stroke is reduced to that of a nonsmoker. The risk of coronary heart disease returns to that of a nonsmoker 15 years after quitting. The sooner a person quits the better, too. Quitting at age 30 can add approximately 10 years of life expectancy compared to waiting until age 60 to quit, which only adds 3 years. A good plan can help reach goals of quitting.

The Great American Smokeout event is dedicated to increasing awareness of the importance of quitting and urges smokers to not only to quit for the day, but to make a plan to quit for good.  

Steps to a good plan for quitting:

  • Make the decision to quit
  • Pick a quit date and mark it on the calendar
  • Inform friends and family for support
  • Purge all cigarettes
  • Practice saying, “No thank you, I don’t smoke.”
  • Review support options such as nicotine replacement therapy, prescription drugs, support programs, acupuncture, herbal supplements, and mind-body practices

On your quit day, be sure to not smoke at all. Staying busy will help keep urges away. Be sure to drink plenty of water, start any nicotine replacement therapy chosen, and avoid situations where smoking is prevalent. If the urge to smoke arises, use the 4 D’s to help fight the urge: delay, deep breathe, drink water, and do something else.

So, take the challenge to invite a smoker in your life to the save the date, Thursday, November 16th, the first day to life without smoking.           

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

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Experience managing all phases of clinical trials

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

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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.

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

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

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