Health and Medical News and Resources

General interest items edited by Janice Flahiff

Assessing positive outcomes of phase III trials

From the December 3, 2010 Eureka news item

Randomized phase III studies should be designed to find out whether a new drug or treatment makes a meaningful difference in patients’ survival or quality of life, according to a commentary published online December 3rd in The Journal of the National Cancer Institute***. Instead, most trials now are designed to detect a statistically significant difference between treatment and control groups, which may not be clinically meaningful, write Alberto Ocana, M.D., Ph.D. and Ian F. Tannock, M.D., Ph.D., of Princess Margaret Hospital in Toronto.

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) approve drugs usually based on statistically significant results of randomized phase III trials comparing a new, investigational drug with standard treatment. Ocana and Tannock note that pharmaceutical companies have typically sponsored clinical trials that are large enough to detect statistically significant differences in survival. But these differences are often trivial, they say. For instance, the trial that led to approval of erlotinib (Tarceva) for pancreatic cancer found that patients who took the drug had a median survival just 10 days longer than patients in the control group. However, the difference was statistically significant, and the drug was approved.

The authors write that pharmaceutical companies look for a difference in survival outcome between two groups of a trial that is “not usually the minimal difference in overall survival or progression-free survival that is clinically important, but more likely the minimal difference that is feasible to detect, considering the limits on the sample size and hence the cost of the trial.”

The authors argue for another approach: “Ideally, trials should be designed [to detect] the minimum clinically important difference, taking into account the tolerability and toxicity of the new treatment, that would persuade oncologists to adopt the news treatment in place of the standard treatment” and investigators should try to reach at least a clinically important difference that was specified in the protocol.

They also suggest that the FDA and EMEA “should define what constitute a positive trial based on the concept of establishing a meaningful clinical benefit for patients similar to those included in any given trial.”

In an accompanying editorial, J. Jack Lee, Ph.D., of the M.D. Anderson Cancer Center, writes that this “excellent commentary” calls for a new drug approval paradigm and challenges both the medical and statistical communities to find a better way to assessing whether a drug really works.

Lee goes on to argue for the adoption of the Bayesian approach in contrast to the more conventional frequentist approach. “Statistics in medicine has passed through its infancy and childhood. As it moves into its adolescence, the growing pains of reconciling frequentist and Bayesian views continue,” he writes. In his view, though, the “roadblocks” of the Bayesian approach, namely the notion of subjectivity and computation difficulty, have been overcome.

“The Bayesian approach is complementary to and can provide a superior alternative to the frequentist paradigm,” Lee writes. “I encourage medical researchers to have an open mind, learn more about Bayesian methods, and apply them to provide a more accurate statistical assessment of the results in clinical trials.”

 

** Please go here for suggestions on how to get this commentary for free or low cost

December 4, 2010 Posted by | Uncategorized | Leave a comment

The gene-environment enigma & personalized medicine

From the December 3, 2010 news item

Personalized medicine centers on being able to predict the risk of disease or response to a drug based on a person’s genetic makeup. But a study by scientists at Washington University School of Medicine in St. Louis suggests that, for most common diseases, genes alone only tell part of the story.

That’s because the environment interacts with DNA in ways that are difficult to predict, even in simple organisms like single-celled yeast, their research shows.

“The effects of a person’s genes – and, therefore, their risk of disease – are greatly influenced by their environment,” says senior author Barak Cohen, PhD, a geneticist at Washington University School of Medicine. “So, if personalized medicine is going to work, we need to find a way to measure a human’s environment.”

The research is available online in PLoS Genetics….

….

The new research raises many questions: what is a human’s environment and how can it be measured? Is the environment a person lived in during childhood important or the environment he lives in now?

Cohen suspects that any environment that matters is likely to leave a measurable molecular signature. For example, eating a lot of fatty foods raises triglycerides; smoking raises nicotine levels; and eating high-fat, high-sugar foods raises blood sugar levels, which increases the risk of diabetes. The key, he says, is to figure out what are good metabolic readouts of the environment and factor those into statistical models that assess genetic susceptibility to disease or response to medication.

“Measuring the environment becomes crucial when we try to understand how it interacts with genetics,” Cohen says. “Having a particular genetic variant may not have much of an effect but combined with a person’s environment, it may have a huge effect.”

Cohen says he’s not hopeless when it comes to personalized medicine. As scientists conduct ever-larger studies to identify rare and common variants underlying diseases such as cancer, diabetes and schizophrenia, they will be more likely to uncover variants that have larger effects on disease. Even then, however, a person’s environment will be important, he adds.

 

 

December 4, 2010 Posted by | Consumer Health, Health News Items | , , , , , | Leave a comment

Preventing physician medication mix-ups by reporting them

From the December 3, 2010 Eurkeka news alert

INDIANAPOLIS – The most frequent contributors to medication errors and adverse drug events in busy primary care practice offices are communication problems and lack of knowledge, according to a study of a prototype web-based medication error and adverse drug event reporting system.

Research on the use of MEADERS (Medication Error and Adverse Drug Event Reporting System), developed by investigators from the Regenstrief Institute and Indiana University School of Medicine led by Atif Zafar, M.D., appears in the November/December 2010 issue of the Annals of Family Medicine.

“We as physicians have a responsibility to make good decisions and to translate those decisions into safe and effective care. If we make a mistake we need to learn from the mistake and prevent it from reoccurring. We found this first generation reporting system to be popular with physicians and others in their offices, in spite of time pressures and a culture that does not support admitting mistakes,” said William M. Tierney, M.D., president and CEO of the Regenstrief Institute. Dr. Tierney, who is also associate dean for clinical effectiveness research at the IU School of Medicine, is a co-developer of MEADERS and is the senior author of the Annals of Family Medicine study.

Urban, suburban and rural primary care practices in California, Connecticut, Oregon and Texas used MEADERS for 10 weeks, submitting 507 confidential event reports. The average time spent reporting an event was a little over four minutes. Seventy percent of reports included medication errors only. Only two percent included both medication errors and adverse drug events.

“Our study has created what is now the largest database of medication errors in primary care,” said Dr. Tierney. “It taught us many real world lessons that we are applying to the next generation reporting system currently under development. It also informed the practices of problems encountered by the doctors, practices and patients in the safe and effective use of drugs. Only by uncovering such problems can they be dealt with to prevent future events. MEADERS allowed a safe and secure means whereby the practices can report such problems.”

Medications used for cardiovascular, central nervous system (including pain killers), endocrine diseases (mainly diabetes), and antibiotics were most often associated with the events reported in MEADERS.

Medication errors were equally divided among ordering medications, implementing prescription orders, errors by patients receiving the medications and documentation errors. There was no harm in two-thirds of the patients, documented harm in 11 percent, and nothing mentioned for 20 percent.

“We demonstrated that it is feasible to deploy a web-based medication event reporting system that clinicians and staff can understand and use in busy primary care practices. The real challenge is to demonstrate that event reporting is sustainable and that the data from event reporting can be used in an ongoing way to identify and to correct systems problems to reduce medication errors, adverse drug events, hospital admissions and patient harm,” said Dr. Tierney.

###

Co-authors of the study in addition to Dr. Tierney and Dr. Zafar are John Hickner, M.D., M.Sc., of the Cleveland Clinic; Grace M. Kuo, PharmD, MPH, of the University of California San Diego; Lyle J. Fagnan, M.D., of the Oregon Health & Science University; Samuel N. Forjuoh, M.D., MPH, DrPH, of Texas A&M Health Science Center; Lyndee M. Knox, Ph.D., of LA Net, A Project of Community Partners; John T. Lynch, MPH, of the Connecticut Center for Primary Care; Brian Kelly Stevens, B.S., formerly of IU School of Medicine; Wilson D. Pace, M.D., of the University of Colorado Health Sciences Center; Benjamin N. Hamlin, MPH, of the National Committee for Quality Assurance (NCQA); Hilary Scherer, B.A., and Caitlin Carroll Oppenheimer, MPH, of NORC at the University of Chicago, and Brenda L. Hudson, M.S., of the IU School of Medicine.

The study was funded by the Agency for Healthcare Research and Quality.

December 4, 2010 Posted by | Consumer Health, Health News Items | | Leave a comment

What Parents Can Do to Create a Positive Youth Sports Experience

From the American Academy of Pediatricians Healthy Children Web Page

What Parents Can Do to Create a Positive Youth Sports Experience

  • Support for your child must be unconditional.
  • Be patient for the process, and enjoy it.
  • Understand how the developmental progression works for sports skills.
  • Be knowledgeable that many of the developmental milestones for sports skills cannot be accelerated beyond their natural limit.
  • Realize that physical, chemical, and mental development all affect ability and all progress along different timetables.
  • Support achievements as they occur. This will reduce pressure to achieve skills that are not quite ready.
  • Remember, your child has his or her own likes and dislikes and should be able to participate without pressure to choose a certain activity.
  • Remember that there are developmental patterns for chemical changes that allow your child to be able to progress in training intensity when it is time.
  • Understand the extra changes that occur in the puberty transition from child to teenager.
  • Don’t overreact to normal developmental processes and changes that occur during puberty and may temporarily affect ability.
  • Understand the profound developmental effect of a firm positive foundation of self-esteem on future performance and ability to handle competitive pressure.
  • Redefine success and make sure performance disappointments are not seen as failures that the child might take personally.
  • Teach your child that winning means a lot more than a gold medal (you first have to believe that yourself).
  • Encourage your child any way you can.
  • Find more things your child is doing right than things to criticize.
  • Support by being visible at their events.
  • Keep your comments positive without a lot of addenda or stipulations.
  • Help your children take some responsibilities for their sport without making them feel overwhelmed with duties.
  • Watch for warning signs of burnout or avoidance.
  • Remember your child is a child, not a child-sized adult.
  • Help your child set realistic goals (not your goals).
  • Allow changes in sports, and encourage exposure to different sports.
  • Instill a sense of value in exercise and fitness regardless of structured competition.
  • Communicate sincerely and often with your child about his or her desires.
  • Help your child build a strong sense of self-worth and identity that is not dependent on the sport itself or level of achievement.
  • Provide positive momentum by celebrating reality successes as often as possible.

 

Author
Paul R. Stricker, MD, FAAP
Last Updated
6/9/2010
Source
Sports Success Rx! Your Child’s Prescription for the Best Experience: How to Maximize Potential AND Minimize Pressure

 

December 4, 2010 Posted by | Health News Items | , , | Leave a comment

10 Tips to Get Your Kids to Eat Vegetables and Fruits

From the American Heart Association Web page

In a new study, children who ate the most vegetables and fruits had significantly healthier arteries as adults than children who ate the fewest.  Here are 10 tips to encourage your children to eat more vegetables and fruits.

1.   Make fruit and vegetable shopping fun: Visit your local green market and/or grocery store with your kids, and show them how to select ripe fruits and fresh vegetables. This is also a good opportunity to explain which fruits and vegetables are available by season and how some come from countries with different climates.

2.   Involve kids in meal prep: Find a healthy dish your kids enjoy and invite them to help you prepare it. Younger kids can help with measuring, crumbling, holding and handing some of the ingredients to you. Older kids can help by setting the table. Make sure you praise them for their help, so they feel proud of what they’ve done.

3.   Be a role model: If you’re eating a wide range of fruits and vegetables — and enjoying them — your child may want to taste. If you aren’t eating junk food or keeping it in your home, your kids won’t be eating junk food at home either.

4.   Create fun snacks: Schedule snack times — most kids like routines. Healthy between-meal snacks are a great opportunity to offer fruits and vegetables. Kids like to pick up foods, so give them finger foods they can handle. Cut up a fruit and arrange it on an attractive plate. Make a smoothie or freeze a smoothie in ice cube trays. Create a smiley face from cut-up vegetables and serve with a small portion of low-fat salad dressing, hummus or plain low-fat yogurt. A positive experience with food is important. Never force your child to eat something, or use food as a punishment or reward.

5.   Give kids choices — within limits: Too many choices can overwhelm a small child. It’s too open ended to ask, “What would you like for lunch?” It may start a mealtime meltdown. Instead, offer them limited healthy choices, such as choosing between a banana or strawberries with their cereal, or carrots or broccoli with dinner.

6.   Eat together as a family: If your schedules permit, family dining is a great time to help your kids develop healthy attitudes about food and the social aspects of eating with others.  Make sure you are eating vegetables in front of your children. Even if they aren’t eating certain vegetables yet, they will model your behavior.

7.   Expect pushback: As your kids are exposed to other families’ eating habits, they may start to reject some of your healthy offerings. Without making a disparaging remark about their friends’ diet, let your children know that fruits and vegetables come first in your family.

8.   Grow it: Start from the ground up — create a kitchen garden with your child and let them plant tomatoes and herbs, such as basil and oregano in window boxes. If you have space for a garden, help them cultivate their own plot and choose plants that grow quickly, such as beans, cherry tomatoes, snow peas and radishes. Provide child-size gardening tools appropriate to their age.

9.   Covert operations: You may have tried everything in this list and more, yet your child’s lips remain zipped when offered a fruit or vegetable. Try sneaking grated or pureed carrots or zucchini into pasta or pizza sauces. Casseroles are also a good place to hide pureed vegetables. You can also add fruits and vegetables to foods they already enjoy, such as pancakes with blueberries, carrot muffins or fruit slices added to cereal. On occasions when you serve dessert, include diced fruit as an option.

10. Be patient: Changes in your child’s food preferences will happen slowly. They may prefer sweet fruits, such as strawberries, apples and bananas, before they attempt vegetables. Eventually, your child may start trying the new vegetable. Many kids need to see and taste a new food a dozen times before they know whether they truly like it. Try putting a small amount of the new food — one or two broccoli florets — on their plate every day for two weeks; but don’t draw attention to it.

December 4, 2010 Posted by | Nutrition | , , , , , , , , | Leave a comment

Healthy People 2020 sets health promotion, disease prevention agenda for the nation

Healthy People.gova mother and her child

From the Healthy People about page

Healthy People provides science-based, 10-year national objectives for improving the health of all Americans. For 3 decades, Healthy People has established benchmarks and monitored progress over time in order to:

  • Encourage collaborations across sectors.
  • Guide individuals toward making informed health decisions.
  • Measure the impact of prevention activities.

Healthy People 2020 strives to:

  • Identify nationwide health improvement priorities.
  • Increase public awareness and understanding of the determinants of health, disease, and disability and the opportunities for progress.
  • Provide measurable objectives and goals that are applicable at the national, State, and local levels.
  • Engage multiple sectors to take actions to strengthen policies and improve practices that are driven by the best available evidence and knowledge.
  • Identify critical research, evaluation, and data collection needs.

The 40+  2020 topics and objectives include

December 4, 2010 Posted by | Educational Resources (High School/Early College(, Librarian Resources, Professional Health Care Resources, Public Health | , , , | Leave a comment

   

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