Colorectal Cancer Awareness Month good time to talk about screening guidelines

COLUMBIA, Md. /PRNewswire/ — March is National Colorectal Cancer Awareness Month and a new survey conducted by MedStar Health shows people need more education when it comes to colon cancer screening.

Colorectal cancers are the fourth-leading cause of cancer-related deaths in the U.S., according to the Centers for Disease Control and Prevention. The best way to prevent those deaths is through early detection. 

The survey of 1000 American adults found: 

• 59% are concerned about getting colorectal cancer.
• Just 22% identified the correct age for a first colonoscopy. 
• Only 11% knew the regular schedule to receive colonoscopies for people with normal risk. 
• Only 21% of people over 45 got their first colonoscopy according to the recommendation.

“These important guidelines have been out for three years now, and we hope people are getting the message,” said Joseph Jennings, MD, MedStar Health gastroenterologist. “In 2020, the recommendations changed so people with average risk for colon cancer, meaning no family history and no symptoms, should start at age 45. The exceptions are for people with known family history of colon cancer or have certain genetic syndromes that would mean they should start earlier.”

With only 21% of those surveyed reporting they had a colonoscopy according to the 2020 guidelines, Dr. Jennings suspects they just haven’t heard about the new recommendations or they’re anxious about the preparation involved. Fortunately, he says the days of drinking liters and liters of a white chalky liquid for colonoscopy prep are over.

“Now we have smaller volumes, down to a couple of milliliters of fluid to drink, or even pills that can be taken with water and sports drinks that make the necessary prep much more palatable.  The cleaner the colon the safer and more effective the colonoscopy is. It’s still not fun, but the preparation has gotten much easier,” Dr. Jennings said.

Dr. Jennings says colonoscopy is the only test available that allows physicians to find the smallest of polyps that can become cancer and remove them at the same time.

“This age guideline of 45 can help us find the polyps when they are smaller and easier to remove and, in the end, save lives,” said Dr. Jennings.

Colorectal cancer does not always have symptoms, but they can include a change in bowel habits, blood in stool, diarrhea, constipation, abdominal pain, or unexplained weight loss.

SOURCE MedStar Health

https://stmdailynews.com/category/lifestyle/

More than 90% say youth coaches should be trained in concussion protocols

COLUMBIA, Md. /PRNewswire/ — A new survey from MedStar Health is highlighting significant injury concerns heading into the spring youth sports season. Following a series of highly publicized injuries in professional sports over the past year, prioritizing concussion safety is now top of mind for parents.

According to parent respondents, 93% have concerns about concussions and 91% percent believe youth sports coaches should be trained concussion protocols and CPR. This compares to a 2019 study of parents, which found that only slightly more than half of parents were worried about concussions.

“Parents are realizing that regardless of age, returning to a sport with concussion symptoms can lead to a more serious injury,” said Karen Laugel, MD, medical director of MedStar Health Concussion Clinics. “Youth sports coaches are often called upon to evaluate an injured athlete on the field and know when to refer them for medical care. Later, coaches may be asked to help supervise athletes through a ‘Return to Play’ protocol. No athlete should be allowed to return to contact sports without written medical clearance.”

Despite the increased concerns of parents, respondents show an inconsistent knowledge of current concussion protocols. The survey found that:

• 89% believe a person suffering from a concussion must stay awake, which is an outdated guideline — in general, sleep is healing.
• 65% believe helmets prevent concussions and almost half believe concussions can only occur from a direct hit to the head. Although helmets do not prevent concussions, they lower the risk of skull fracture and of loss of consciousness and are recommended if fitted properly.
• 13% believe an athlete can continue to play after a head injury as long as they don’t lose consciousness — yet, the majority of concussions do not involve loss of consciousness.

“If athletes aren’t aware of their concussion symptoms after a body blow, fall, or hit to the head, they may think it’s safe to return to play. It’s critical that coaches, athletic trainers, and parents discuss concussion symptoms with athletes before the season starts and encourage them to report symptoms and remove themselves from play. It’s difficult to come out of a game, and parents and coaches can support their athletes by showing them it’s the right thing to do.”

According to Laugel, the majority of injured athletes who are removed from play experience temporary symptoms. However, if an injured child is showing progressive symptoms like worsening headache, frequent vomiting, slurred speech, worsening imbalance, or increased confusion, parents or coaches should call 911 for transport to an emergency department. If symptoms are milder, they can seek treatment from an urgent care clinic or primary care provider. If necessary, the athlete can also be referred to a concussion clinic, like the MedStar Health Clinic for Concussion Traumatic Brain Injury, for continued care.

MedStar Health’s survey included responses from 1,000 U.S. adults collected in Feb. 2022.

SOURCE MedStar Health

https://stmdailynews.com/category/lifestyle/

The U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications. The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints likely to predict clinical benefit.

“The FDA’s accelerated approval program has provided patients with cancer earlier access to novel treatments that can be practice changing,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “Today’s draft guidance provides recommendations to sponsors for designing clinical trials to support accelerated approval. Building quality and efficiency into the design of oncology clinical trials is a crucial component in providing maximum benefit to those living with cancer.”

The draft guidance discusses the design of clinical trials, and ways to improve the data available at the time of accelerated approval and reduce clinical uncertainty for patients by initiating postmarketing confirmatory studies in a timely manner. Specifically, the draft guidance addresses the design, conduct and analysis of data through two randomized clinical trial approaches – conducting two separate randomized controlled clinical trials or using one trial for both accelerated approval and to verify clinical benefit. The draft guidance also provides considerations for sponsors to determine the adequacy of single-arm studies to support an application.
  
For drugs granted accelerated approval, postmarketing confirmatory trials have been required to verify and describe the anticipated clinical benefit. The draft guidance discusses a potential advantage of randomized clinical trials–compared to single-arm trials–by highlighting that use of the one-trial approach, in appropriate cases, may not require separate clinical trials because longer term follow-up in the same trial could fulfill a postmarketing requirement to verify clinical benefit. Moreover, confirmatory trials that are in progress at the time of accelerated approval are more likely to result in a timely verification of clinical benefit, therefore minimizing the period of uncertainty for patients.

In a commentary in the New England Journal of Medicine in 2022External Link Disclaimer, Oncology Center of Excellence staff outlined the concepts included and expanded upon in the draft guidance. The Oncology Center of Excellence has also launched Project Confirm, as an initiative that promotes the transparency of outcomes related to accelerated approval for oncology indications and  fosters discussion and research on the accelerated approval program. The project developed a searchable database with information on the status of all oncology accelerated approvals, a model that was then adopted by FDA’s Center for Drug Evaluation and Research for all accelerated approvals.

Related Information

• Oncology Center of Excellence Guidance Documents
• Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics Guidance for Industry 
• Accelerated Approval Program
• Project Confirm

Source: FDA