Patient-reported outcomes essential to comparative effectiveness research

The Human Body — Cancer (Photo credit: n0cturbulous)

 

From the 16 October 2012 article at EurekAlert

 

Patient perspective key to adequate evaluation of cancer treatment

Chapel Hill, NC – Patient-reported outcomes should be a standard part of evaluating the comparative effectiveness of cancer treatments, according to recommendations put forward by a multi-institution research group.

In an early release article published this week online in the Journal of Clinical Oncology, a research group led by Ethan Basch, MD, Director of the Cancer Outcomes Research Program at UNC Lineberger Comprehensive Cancer Center, recommends that patient-reported symptoms and health-related quality of life measures should be assessed in comparative effectiveness studies designed to generate new evidence about cancer treatment. The article was written on behalf of the Center for Medical Technology Policy in Baltimore, MD.

Comparative effectiveness research is designed to inform health-care decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options. The evidence is generated from research studies that compare drugs, medical devices, tests, surgeries, or ways to deliver health care.

“Comparative effectiveness research looks at how treatment options perform in a real-world setting, and is particularly important in cancer treatment, where patients are not only fighting their disease but also enduring treatments that may have a significant impact on their ability to function and their quality of life,” said Basch.

“There is no way to adequately assess a treatment’s impact on the patient without including their point of view, gleaned directly from asking about their experience in a consistent and scientifically-validated manner. Without this information, stakeholders – including patients, physicians and nurses, payers, researchers and regulators – have incomplete information for decision making about a given treatment.”

The group recommends evaluation of a set of twelve core symptoms in studies in advanced or metastatic cancers, use of standard, validated measurements for patient-reported outcomes, to identify specific symptoms that may be relevant in studies of treatment for particular forms of cancer, and methods to gather the relevant data efficiently and effectively.

 

 

 

 

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Scientists to EPA: Include Women in Reproductive Health Research

Oncofertility Consortium Logo (Photo credit: Wikipedia)

 

From the Northwestern University press release (October 17, 2012)

 

Northwestern scientists to meet with EPA to request important changes in guidelines

October 16, 2012 | by Marla Paul

CHICAGO — A team of Northwestern University scientists will meet with Environmental Protection Agency (EPA) administrators in Washington D.C. Oct. 18 to advocate for important changes in the agency’s guidelines for reproductive health research.

“The problem is current research assessing the risk of toxins on reproductive health is not being uniformly investigated in both sexes and across the lifespan,” said Kate Timmerman, program director of the Oncofertility Consortium of Northwestern University, who will be one of the scientists meeting with the EPA. The reproductive health guidelines have not been updated since 1996 and need to be revised to reflect new research findings.

The Northwestern team will ask the EPA to expand the definition of reproductive health beyond pregnancy to include the lifespan of an individual.

“Reproductive health is important across the entire lifespan because your endocrine system affects your bone health, cardiovascular health and other systems in the body,” Timmerman said. Endocrine disrupters, sometimes triggered by environmental factors, can lead to increased risk for stroke and heart attack as well as osteoporosis.

The Northwestern scientists also will request that all EPA-sponsored research require appropriate testing in both sexes. Currently many toxicity studies are only conducted in male animal models with the assumption that females are affected the same way, but that isn’t necessarily true.

“What happens now is if researchers don’t see an effect in males, they won’t look in females,” Timmerman said. “But we know certain toxins in the environment can have a significant effect on females and not males and vice versa.”

Timmerman and colleagues will present a white paper to the EPA on how to improve and update the guidelines.

In addition to Timmerman, other Northwestern scientists meeting with the EPA

include Kimberly Gray, professor of civil and environmental engineering at Northwestern’s  McCormick School of Engineering and Applied Science; Mary Ellen Pavone, M.D., assistant

professor of obstetrics and gynecology at Northwestern’s Feinberg School of Medicine and a physician at Northwestern Memorial Hospital; and Francesca Duncan, reproductive scientist/research associate in the lab of Teresa Woodruff, chief of fertility preservation at the Feinberg School and director of the Oncofertility Consortium. Woodruff also is a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

 

 

 

Related articles

• Scientists to EPA: Include women in reproductive health research (sciencedaily.com)

 

In Clinical Trials About Half Of New Treatments Perform Better Than Existing Treatments

the-cochrane-library (Photo credit: Wiley Asia Blog)

 

From the 18 October 2012 article at Medical News Today

 

On average, new treatments perform better in clinical trials only slightly more often than existing treatments, according to a new systematic review published in The Cochrane Library. The fact that experimental treatments are not more effective may seem disappointing, but the authors of the review say their findings satisfy an important ethical requirement for clinical trials.

Randomised trials compare the effects of one treatment to another. In a randomised trial patients are randomly allocated to different treatment groups to ensure that like will be compared with like. When a new treatment is being tested, it is hoped or even expected that it will be better than the established treatment with which it is being compared. These expectations lead to an ethical dilemma. If the researchers already know that one treatment is better, they would be knowingly allocating some people to an inferior treatment. If randomised trials are to be ethical, therefore, only half of new treatments should turn out to be better than existing ones.

 

Related Resources

 

• Cochrane Reviews
  

 

Cochrane Reviews are systematic reviews of primary research in human health care and health policy, and are internationally recognised as the highest standard in evidence-based health care. They investigate the effects of interventions for prevention, treatment and rehabilitation. They also assess the accuracy of a diagnostic test for a given condition in a specific patient group and setting. They are published online in The Cochrane Library.

 

• Browse Free Summaries

  Looking for the full text of these Cochrane Reviews? They may be available at your local public, academic, and medical libraries.  Call ahead and ask for a reference librarian. Many academic and medical libraries do serve the public, providing at least some basic services.

• ClinicalTrials.gov

 

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

• How to find results of studies

 

 

 

 

 

 

 

Related articles

• Clinical trials: Around half of new treatments perform better than existing treatments (medicalxpress.com)
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• Clinical Trials (cancerwhattodoorsay.wordpress.com)
• Clinical trials better than before (wlfi.com)

 

Plant-Based Diets Can Remedy Chronic Diseases

From the 17 October article at ScienceNewsDaily

According to the World Health Organization (WHO), 63 percent of the deaths that occurred in 2008 were attributed to non-communicable chronic diseases such as cardiovascular disease, certain cancers, Type 2 diabetes and obesity — for which poor diets are contributing factors. Yet people that live in societies that eat healthy, plant-based diets rarely fall victim to these ailments. Research studies have long indicated that a high consumption of plant foods is associated with lower incidents of chronic disease. In the October issue of Food Technology magazine, Senior Writer/Editor Toni Tarver discusses recent discoveries in nutritional genomics that explain how plant-based diets are effective at warding off disease.

The article indicates that bioactive compounds in plant foods play a role in controlling genetic and other biological factors that lead to chronic disease. For example, antioxidants in plant foods counter free radicals that can cause chronic inflammation and damage cells. And other plant compounds help control a gene linked to cardiovascular disease and plaque buildup in arteries and the genes and other cellular components responsible for forming and sustaining tumors…

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Does True Love Wait? Age of First Sexual Experience Predicts Romantic Outcomes in Adulthood

Please read the entire article, there are many factors that need to be “teased out” in future studies (as the author emphasizes).
A fascinating read, nonetheless.

From the 17 October 2012 article at ScienceNewsDaily

It’s a common lament among parents: Kids are growing up too fast these days. Parents worry about their kids getting involved in all kinds of risky behavior, but they worry especially about their kids’ forays into sexual relationships. And research suggests that there may be cause for concern, as timing of sexual development can have significant immediate consequences for adolescents’ physical and mental health.

But what about long-term outcomes? How might early sexual initiation affect romantic relationships in adulthood?

Psychological scientist Paige Harden of the University of Texas at Austin wanted to investigate whether the timing of sexual initiation in adolescence might predict romantic outcomes — such as whether people get married or live with their partners, how many romantic partners they’ve had, and whether they’re satisfied with their relationship — later in adulthood…

Read the entire article here

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Why clinical decision making in psychiatry is difficult

English: medications (Photo credit: Wikipedia)

 

From the post by JULIA FRANK, MD on October 17th, 2012 at KevinMD.com

 

All psychiatrists do is push drugs!”

I have heard this repeatedly, from students, wary patients, even family members who don’t pick up on a carefully worded hint that they just might benefit from getting help.  For some reason, no one makes the same complaint about infectious disease specialists, or oncologists, though I wager that the success rates of our drug treatments are roughly equivalent.

 

As a psychiatrist, I try to treat people with diseases, not diseases that happen to occur in people, but combining drugs with other modes of therapy requires a daily, even hourly balancing act. Add the effects of pharmaceutical marketing, especially direct to consumer advertising (followed by direct potential litigant recruitment)–some days I don’t want to get out of bed.

Beyond a general temptation to rely on drugs as the primary mode of treatment, psychiatrists feel particularly pressed to use the newest, most expensive drug. Many psychiatric patients receive their care in publicly funded clinics, under excruciatingly tight budgets. Having free samples to distribute allows us to provide a few patients with high end drugs. Clinical decision making in psychiatry is difficult because of our lack of objective measures of response. Newer psychotropic medicines do sometimes work where older ones have failed. The side effects of newer medications typically differ from those of older ones, though the overall burden of adverse consequences is arguably the same. These background forces are invisible. In the clinical moment, the selection of a particular remedy is often based more on nonmedical influences—the patient’s response to advertising, the clinic’s necessary concern with costs—than upon the prescribing professional’s careful assessment and detailed discussion with a patient.

Aggressive pharmaceutical marketing has exacerbated the problem of responsible prescribing…

..

Although radical reform is still a long way off, section 6002 of the Patient Protection Affordable Care Act requires manufacturers of drugs, devices, supplies and biological materials that are covered under various federal health programs to disclose on an annual basis the payments (of various kinds) they have made to physicians and teaching hospitals.

 

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October is Children’s Health Month

Child Development (Photo credit: Wikipedia)

From an email recently received from USA.gov

October is Children’s Health Month. If you are a parent or caregiver, check out these resources to help promote your child’s good health:

• Vaccines — Vaccination is one of the best ways to protect children from several potentially serious diseases. Get recommended vaccine information based on your child’s age group.
• Nutrition Resources and 10 Kid-Friendly Veggies and Fruits (pdf) — Encourage children to eat vegetables and fruits by making it fun. Get ideas for healthy snacks and meals.
• Child Development — Get the basics about healthy development; learn about specific conditions that affect development; get parenting tips; and more.
  
• Developmental Milestones — Skills such as crawling, walking, and waving are developmental milestones. Check out milestones for children between the ages of two months and five years.
• Oral Health — Find out what you can do to help prevent tooth decay and other oral diseases.
  
• Child Safety — Get resources to help keep your child safe during different stages of development.
  
• Physical Activity — Children need 60 minutes of play with moderate to vigorous activity every day. Get ideas for steps you can take to increase your child’s level of activity.
  

Many elements contribute to a child’s good health and overall well-being. Find additional topics on children’s health.

Related articles

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