Clinical Trials: Benefits, Risks, and Safety

 

You may ask yourself, “Why should I try something that researchers are not sure will work?” That is a good question. Being part of a clinical trial may have risks, but it may also have benefits.Older couple listening about the benefits, risks, and safety protections of clinical trials

Benefits of a Clinical Trial

  • You may get a new treatment for a disease before it is available to everyone.
  • You play a more active role in your own health care.
  • Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
  • You may have the chance to help others get a better treatment for their health problems in the future.
  • You may be able to get information about support groups and resources.

Risks of a Clinical Trial

  • The new treatment may cause serious side effects.
  • The new treatment may not work or it may not be better than the standard treatment.
  • You may NOT be part of the treatment group (or experimental group) that gets the new treatment—for example, a new drug or device. Instead, you may be part of the control group, which means you get the standard treatment or a no-treatment placebo.
  • The clinical trial could inconvenience you. For example, medical appointments could take a lot of time or you might be required to stay overnight or a few days in the hospital.

How Will My Safety Be Protected?

This is a very important question. The history of clinical research is not perfect. Based on many years of experience and learning, Congress has passed laws to protect study participants. Today, every clinical investigator is required to monitor and make sure that every participant is safe. These safeguards are an essential part of the research. Research abuses like the Tuskegee Syphilis Experiment, which began in 1932, before safeguards were in place, will NOT happen again.

Researchers are required to follow strict rules to make sure that participants are safe. These rules are enforced by the Federal Government. Each clinical trial also follows a careful study plan or protocol that describes what the researchers will do. The principal investigator, or head researcher, is responsible for making sure that the protocol is followed.

An Institutional Review Board, or IRB, at each study site must approve every clinical trial in the United States. The IRB is made up of doctors, scientists, and lay people, like yourself, who are dedicated to making sure that the study participants are not exposed to unnecessary risks. The people on the IRB regularly review the study and its results. They make sure that risks (or potential harm) to participants are as low as possible.

Along with the IRB, many clinical trials are closely supervised by a Data and Safety Monitoring Committee. The Committee is made up of experts in your condition who periodically look at the results of the study as it is in progress. If they find that the experimental treatment is not working or is harming participants, they will stop the trial right away.

The informed consent process also helps protect participants. Before joining a clinical trial, you will be told what to expect as a participant and all the things that might happen. For example, someone from the research team will explain possible side effects or other risks of the treatment. As part of the informed consent process, you will have a chance to ask questions about the trial. The clinical trial coordinator will be happy to answer your questions.

After getting all this information, you can think about whether or not you want to participate. If you decide to join the trial, you will be given an informed consent form to sign. By signing the form, you show that you have been told all the details and want to be part of the study. The informed consent form is NOT a contract. You can leave the trial at any time and for any reason without being judged or put in a difficult position regarding your medical care. Researchers must keep health and personal information private.

Source link

Here comes the sun, and kid sun safety

(HealthDay)—Summer sun brings childhood fun, but experts warn it also brings skin cancer dangers, even for kids.

“Don’t assume children cannot get skin cancer because of their age,” said Dr. Alberto Pappo, director of the solid tumor division at St. Jude Children’s Research Hospital in Memphis, Tenn. “Unlike other cancers, the conventional melanoma that we see mostly in adolescents behaves the same as it does in adults.”

His advice: “Children are not immune from extreme sun damage, and parents should start sun protection early and make it a habit for life.”

So, this and every summer, parents should take steps to shield kids from the sun’s harmful UV rays.

Those steps include:

* Avoid exposure. Infants and children younger than 6 months old should avoid sun exposure entirely, Pappo advised. If these babies are outside or on the beach this summer, they should be covered up with hats and appropriate clothing. It’s also a good idea to avoid being outside when UV rays are at their peak, between 10 a.m. and 2 p.m.

* Use sunscreen. It’s important to apply a broad-spectrum sunscreen to children’s exposed skin. Choose one with at least SPF15 that protects against both UVA and UVB rays. Pappo cautioned that sunscreen needs to be reapplied every couple of hours and after swimming—even if the label says it is “water-resistant.”

However, sunscreen should not be used on infants younger than 6 months old because their exposure to the chemicals in these products would be too high, he noted.

* Keep kids away from tanning beds. Melanoma rates are rising among teenagers, partly due to their use of indoor tanning beds. Use of tanning beds by people younger than 30 boosts their risk for this deadly form of cancer by 75 percent, according to the International Agency for Research on Cancer.

* Get children screened. Early detection of melanoma is key to increasing patients’ odds of survival. Children with suspicious moles or skin lesions should be seen by a doctor as soon as possible, Pappo advised. Removing melanoma in its early stages also increases the chances of avoiding more invasive surgical procedures later on, he added.

More information: There are more sun-safety tips at the Skin Cancer Foundation.

Teen Suicide Prevention

In this video created by Mayo Clinic, teens describe common signs that a teen is considering suicide and provide encouragement for communicating directly and immediately for support and safety. It also Includes suggestions for what to say to a teen who may be at risk for suicide and ways to keep them safe. Things can get better.

For more information-
Call: 1-800-273-TALK, 1-800-273-8255
Visit: http://www.suicidepreventionlifeline.org/

source


About HealthLynked

Improving healthcare is the mission of HealthLynked. HealthLynked focuses on improving healthcare services for patients as well as physicians. Our technology shortens wait time with online scheduling of appointments, Real-time appointments by local providers and provides easy access to yours as well as your family’s updated medical records.

Appointments can be comfortably made online and providing your healthcare provider access to your medical files. The website also makes it possible to link together family members and provide access to critical information in case of an emergency

Download APP Now

Future of HealthCare

14 Bolts of Inside[r] Info on Lightning | National Safety News

This weekend, for Father’s Day, I had the opportunity to celebrate early with my oldest, her husband and their newborn.  They asked me what I wanted to do, and I volunteered a boat ride to a distant restaurant on the lake we all love.  I say this, but I know my wife, wisely, does not always enjoy the ride, mostly because of the wicked weather that often kicks up on the warm afternoons where we live.

We always check the satellite and motored out after seeing we were clear for the rest of the day.  After dinner, we checked again before shoving off to see a few storms were popping up about 45 miles away.  NO threat to our return leg.

As we headed home, a cloud to the east, where we were headed, started to take on a more ominous shape and started spitting a little rain.  Then, it deeply darkened, and streaks of lightning shot to earth underneath.

We skirted the storm for 30 minutes and headed to a place we knew we could find shelter.  We hunkered down for about an hour, then headed home, a little more tired but safe after the slight scare.  While we did a lot of things right, I recognize now, we also were at significant risk.  The wide eyed look of my granddaughter will always remind me of this.

Summertime across the country means barbecues, festivals, sporting events, boating, hitting the beach, camping, and many other recreational activities. In short, summertime means a lot more people are spending a lot more time in the great outdoors.

We always look forward to the outdoor adventuring this time of the year brings, but it is also the peak season for one of the nation’s deadliest weather phenomena — lightning. Lightning typically receives less attention than other storm-related killers because it does not result in mass destruction or mass casualties like tornadoes, floods, tsunamis or hurricanes often do.

Consider these lightning statistics:

  • About 25 million cloud-to-ground lightning strikes occur in the United States each year. Around the globe, there are about 100 strikes every second!
  • Over the last 30 years, the U.S. has averaged 51 lightning fatalities per year. The great news:  2017 was the least lethal year since we started recording the stats in 1940, with only 16 deaths.  This is most likely due to increasing awareness.
  • Only about 10% of people struck by lightning are actually killed. The other 90% must cope with varying degrees of discomfort and disability, sometimes for the rest of their lives.
  • People struck by lightning are not electrified! They will need your immediate medical attention or first aid.  Help them immediately.
  • Typically, the vast majority of lightning victims each year are male (in 261 instances from 2006-2013, 81% of lightning fatalities were male and 19% were female).

The purpose of Lightning Safety Awareness Week is to educate and raise awareness about the hazards of lightning in order to lower the number of deaths and injuries caused by lightning strikes. Remember, lightning makes every single thunderstorm a potential killer, whether the storm produces one single bolt or ten thousand bolts. 

 Lightning Fatality Statistics

From 2006 through 2017, 376 people were struck and killed by lightning in the United States.  Almost two thirds of the deaths occurred to people who had been enjoying outdoor leisure activities.  The common belief that golfers are responsible for the greatest number of lightning deaths was shown to be a myth.  During this 12-year period fishermen accounted for more than three times as many fatalities as golfers, while beach activities and camping each accounted for about twice as many deaths as golf.  From 2006 to 2017, there were a total of 34 fishing deaths, 22 beach deaths, 19 camping deaths, and 17 boating deaths.

Of the sports activities, soccer saw the greatest number of deaths with 12, as compared to golf with 10.  Around the home, yard work (including mowing the lawn) accounted for 14 fatalities.  For work-related activities, ranching/farming topped the list with 17 deaths.

Males accounted for 80% of all fatalities, and more than 90% of the deaths in the fishing, sports and work categories.  Females had comparatively fewer deaths than men in every category, with their highest percentages in the boating-related activities (35%) and routine daily/weekly activities (34%).

June, July, and August are the peak months for lightning activity across the United States and the peak months for outdoor summer activities.  As a result, more than 70% of the lightning deaths occurred in the months of June, July, and August, with Fridays, Saturdays, and Sundays having slightly more deaths than other days of the week.

Ages of the victims varied from young children to older adults with the greatest number of fatalities between the ages of 10 and 60.  Within that age range, there was a relative minimum in deaths for people in their 30s, possibly due to parents of young children being less involved in vulnerable activities.

Based on the media reports of the fatal incidents, many victims were either headed to safety at the time of the fatal strike or were just steps away from safety.  Continued efforts are needed to convince people to get inside a safe place before the lightning threat becomes significant.  For many activities, situational awareness and proper planning are essential to safety.

To put this all into perspective, while you are more likely to be struck TWICE  by lightning than win the lottery, you are TWICE as likely to be killed by a dog attack than lightning.  Some small comfort.

Lightning Myths and Facts

 

Myth: A lightning victim is electrified. If you touch him, you’ll risk being electrocuted.
Fact: The human body does not store electricity, and lightning victims require immediate medical attention. It is perfectly safe to touch a lightning victim in order to give them first aid. Call 911 for help.

Myth: If it’s not raining or there aren’t any clouds overhead, you’re safe from lightning.
Fact: Lightning often strikes several miles from the center of a thunderstorm, far outside the rain or thunderstorm cloud. In fact, “bolts from the blue” can strike as far as 25 miles out from the parent thunderstorm. That’s why it’s important to seek shelter at the first indication of a thunderstorm and stay there until 30 minutes after the last clap of thunder.

Myth: The rubber soles of shoes or rubber tires on a car will protect you from a lightning strike.
Fact: Rubber-soled shoes and rubber tires provide NO protection from lightning, but most vehicles with metal tops and sides do provide adequate shelter from lightning because the charge travels through the metal frame and eventually into the ground. Just be sure to avoid contact with anything inside the vehicle that conducts electricity. Remember, convertibles, motorcycles, bicycles, open-shelled outdoor recreational vehicles and cars with fiberglass shells offer no protection from lightning.

Myth: “Heat Lightning” occurs after very hot summer days and poses no threat.
Fact: Many people incorrectly think that “heat lightning” is a specific type of lightning. Actually, it is just lightning from a thunderstorm that is too far away for any thunder to be heard (thunder is seldom heard beyond 10 miles under ideal conditions). If the storm approaches, the same lightning safety guidelines above should be followed.

Myth: Lightning never strikes the same place twice.
Fact: Lightning often strikes the same place or object repeatedly, especially if it’s tall, pointy, and isolated. The Empire State Building is struck by lightning nearly 100 times each year.

Myth: If caught outside during a thunderstorm, you should seek shelter under a tree.
Fact: Seeking shelter under a tree is one of the leading causes of lightning related fatalities. Remember, NO PLACE outside is safe when thunderstorms are in the area. If you are caught outside in a thunderstorm, keep moving toward a safe shelter.

Myth: Metal structures or metal on the body (jewelry, watches, etc.) attract lightning.
Fact: The presence of metal has no bearing on where lightning will strike. Mountains are made of rock but get struck by lightning many times a year. Rather, an object’s height, shape, and isolation are the dominant factors that affect its likelihood of being struck by lightning. While metal does not attract lightning, it obviously does conduct electricity, so stay away from metal fences, railings, bleachers, etc. during a thunderstorm.

Myth: If caught outside during a thunderstorm, you should lie flat on the ground.
Fact: NO PLACE outside is safe when thunderstorms are in the area. If you are caught outside in a thunderstorm, keep moving toward a safe shelter.

 Lightning Safety Guidelines

Lightning is one of the most erratic and unpredictable characteristics of a thunderstorm. Because of this, no one can guarantee an individual or group absolute protection from lightning. However, knowing and following proven lightning safety guidelines can greatly reduce the risk of injury or death.

Most lightning victims are not struck during the worst of a thunderstorm but rather before or after the storm reaches its greatest intensity. This is because many people are unaware that lightning can strike as far as 25 miles away from its parent thunderstorm – much farther out from the area of rainfall within the storm!  “Blue sky” lightning is common at 10 miles from an area storm.

Therefore, if you can hear thunder, you are within striking distance. Seek safe shelter immediately. Remember this lightning safety rule: WHEN THUNDER ROARS, GO INDOORS…and stay there until 30 minutes after the last clap of thunder. Do not wait for the rain to start before you decide to seek shelter, and do not leave shelter just because the rain has ended.

The best way to protect yourself and your family from the dangers of thunderstorms is to be prepared. If you have outdoor plans, be sure to familiarize yourself with the latest weather forecast before heading out. Upon arriving on-site, determine where you will seek shelter in the event of a thunderstorm and how long it would take to reach that shelter. A sturdy, enclosed structure with plumbing and electrical wiring is safest, but if one is not available most enclosed metal vehicles are safe alternatives.

Cancel or postpone outdoor activities if thunderstorms develop.  During your outdoor activities, keep an eye to the sky for developing thunderstorms. If thunder is heard, if lightning is seen, or even if thunderclouds are developing, get to your place of shelter without delay! Have a lightning safety plan.

WHERE NOT TO GO:

Not all types of buildings or vehicles are safe during thunderstorms. Buildings with exposed sides are NOT safe(even if they are “grounded”). These include beach shacks, metal sheds, picnic shelters/pavilions, carports, and baseball dugouts. Porches are dangerous as well.

Convertible vehicles offer no safety from lightning, even if the top is up. Other vehicles which are NOT safe during thunderstorms are those with open cabs, such as golf carts, tractors, and construction equipment.

WHERE TO GO:

The safest location during a thunderstorm is inside a large enclosed structure with plumbing and electrical wiring. These include shopping centers, schools, office buildings, and private residences. If lightning strikes the building, the plumbing and wiring will conduct the electricity and eventually direct it into the ground.

If no substantial buildings are available, then an enclosed metal vehicle such as an automobile, van, or school bus would be a suitable alternative.

While being inside a house or other building with electrical wiring and plumbing is your safest option during a thunderstorm, it does not guarantee you will be 100% safe from lightning. There are still some lightning safety guidelines you must follow while inside a place of shelter to keep yourself safe.

  • Don’t use corded phones:  Using a corded phone during a thunderstorm is one of the leading causes of indoor lightning injuries. However, it IS safe to use cordless or cell phones as long as they are not being charged.
  • Stay away from windows and doors:Sitting on an open porch to watch a thunderstorm is also dangerous. It is best to be in an interior room during a thunderstorm.
  • Don’t touch electrical equipment or cords:  Any device that uses electricity (e.g. computers, televisions, household appliances, etc.) is susceptible to a lightning strike. Electrical surges caused by lightning can damage electronics (even at some distance from the actual strike), and a typical surge protector will do little to protect the device (or the person using it) if lightning should strike. So, consider unplugging certain appliances or electronics, but for your own safety do this BEFORE the storm arrives.
  • Avoid plumbing:  Metal plumbing and the water inside are both very good conductors of electricity. Therefore, do not wash your hands or dishes, take a shower or bath, do laundry, etc. during a thunderstorm.
  • Refrain from touching concrete surfaces:Lightning can travel through the metal wires or bars in concrete walls and flooring, such as in the basement or garage.
  • If inside a vehicle:  Roll the windows up and avoid contact with any conducting paths leading to the outside of the vehicle (e.g. metal surfaces, ignition, portable electronic devices plugged in for charging, etc.).

While we won’t be there to warn you of an impending strike, we will always be there with Ready medical Information if you ever need to call for emergency services.  With HealthLynked, you are able to compile and safely collate all of your medical information in one convenient place should you ever need to access it fast.

Come in out of the rain and steer clear of the storm of finding a physician just right for you.  Go to HealthLynked.com today to sign up for Free and take comfort knowing your health information is with you wherever you may go….

Stay safe!

Sources:

weather.gov

nationalgeographic.com