Minimizing diagnostic error in medicine is an essential component of safe patient care, a theme to be explored by the physicians, medical scientists, safety officers, risk managers, and educators who will convene at the 2nd Annual Diagnostic Error in Medicine Conference, to be held at the Renaissance Hollywood Hotel on October 2122 in Los Angeles. The conference reviews current research in diagnostic error, emerging ideas on reducing error, and considers how to teach clinical reasoning.

The meeting is cohosted by Stony Brook University Medical Center, Stony Brook, N.Y., and Brigham and Womens Hospital in Boston. It is also sponsored by the Society for Medical Decision Making and the Agency for Healthcare Research and Quality.

“The healthcare community is just starting to address the problem of diagnostic error, despite the enormous harm these mistakes can cause,” says Mark L. Graber, M.D., Professor and Associate Chair, Department of Medicine, Stony Brook University Medical Center, and Chief, Medical Service, Northport VA Medical Center, and chair of the conference. Dr. Graber has researched diagnostic error in medicine and related issues for the past 10 years. He started Patient Safety Awareness Week in 2002 and chaired the first national conference on diagnostic error in 2008.

“There is a job for everyone in reducing diagnostic error physicians, who should lead the charge, the healthcare system, and patients and each group needs to understand key steps they can take to reduce error,” he adds.

Physicians, Dr. Graber explains, should recognize their propensity to err, understand the causes of diagnostic error, work with the healthcare system to fix as many flaws as possible, and encourage second opinions from colleagues or specialists. Healthcare organizations need to make sure expertise is available when needed for all cases, optimize coordination of care, and facilitate reliable communication. Patients can take a more active role in safety by simply being a good historian of their symptoms and speaking up when it comes to communication with their physicians.

The conference will reinforce these concepts through lectures and educational sessions with the following topics Approaches of leading healthcare organizations to reduce diagnostic error; overview of research to reduce diagnostic error; understanding the root causes of diagnostic error; diagnostic error in emergency and critical care medicine, in primary and ambulatory care, and in perceptual fields (radiology); and developing a national consensus curriculum for clinical reasoning and errorpreventive strategies.

Featured speakers include Jerome P. Kassirer, M.D., Distinguished Professor, Tufts University School of Medicine, and former EditorinChief of the New England Journal of Medicine, who will discuss “Clinical Reasoning Lessons for the 21st Century”; Pat Croskerry, M.D., Ph.D., of Dalhousie University, Nova Scotia, Canada, who will detail “Lessons from the Dual Process Model of Reasoning,” and Wolfgang Gaissmaier, Ph.D., Chief Research Scientist at The Harding Center for Risk Literacy at the Max Planck Institute for Human Development, who will present “Fast and Frugal Decisions Can they be Improved?”

Mental Illness Awareness Week (MIAW) is Oct. 410, 2009 and as part of its observance, the National Alliance on Mental Illness (NAMI) is calling attention to a program now airing on PBS, Minds on the Edge Facing Mental Illness.

Observed annually the first full week in October, Congress established MIAW as a time to raise public awareness of serious mental illnesses such as major depression, bipolar disorder and schizophrenia. Other diagnoses include posttraumatic stress disorder (PTSD) and anxiety disorders, including obsessivecompulsive disorder and borderline personality disorder.

About 60 million Americans experience mental health problems in any given year. One in 17 lives with the most serious conditions. Less than onethird get treatment.

Onehalf of all lifetime cases begin by age 14, but 10 or more years may pass between onset of symptoms and getting help.

“The first step in combating mental illness is education,” said NAMI Executive Director Michael J. Fitzpatrick.

Learn about symptoms that are warning signs.
Learn about different diagnoses and courses of treatment.
Discuss any concerns with a doctor.

Early identification is often the key to recovery. Treatment may involve combinations of medication, cognitive behavioral therapy, interpersonal therapy (”talk therapy”), peer support groups or community services. Diet, exercise, sleep and social support networks also play a role.

“As a society, we also need to strengthen the mental health care system and put an end to the stigma,” Fitzpatrick said.

Many PBS stations nationwide will begin airing Minds on the Edge, produced by Fred Friendly Seminars, Inc., during MIAW. The program explores the medical, legal and personal dimensions of that broader challenge.

Check Local Listings

“Minds on the Edge is perfect for public education,” said Fitzpatrick. “The program brings together some of the best minds in the nation for a fastpaced, lively discussion. It includes realistic scenarios of what can happen to anyone at any time.”

Treating pregnant women for mild gestational diabetes resulted in fewer cesarean sections and other serious birthing problems associated with larger than average babies, according to a study conducted in part at the University of North Carolina at Chapel Hill.

This study is important because it clearly indicates the value to mothers and their newborns of screening for and treatment of diabeteslike conditions provoked by pregnancy,” said John M. Thorp, M.D., McAllister distinguished professor of obstetrics and gynecology at the UNC School of Medicine and a coauthor of the study.

“Our work resolves a 40year controversy in womens health and should be immediately helpful to both pregnant women and the clinicians caring for them.”

The study is published in the Oct. 1 issue of the New England Journal of Medicine. The lead author and principal investigator is Mark B. Landon, M.D. of Ohio State University. It was conducted at 14 sites that are part of the Eunice Kennedy Shriver National Institute of Child Health and Human Development MaternalFetal Medicine Units (MFMU) Network.

About 4 percent of all pregnant women in the U.S. develop gestational diabetes, resulting in about 135,000 cases each year, Thorp said. Because these women have high blood sugar levels, their babies receive more blood glucose than they need, and the extra energy is stored as fat. These babies tend to be larger and fatter than average at birth and thus are more likely to be affected by problems associated with larger babies, such as the need for cesarean delivery, damage to their shoulders during birth and a greater risk of becoming obese as children and developing type 2 diabetes as adults.

There has been a longstanding controversy among physicians on the question of whether treating pregnant women with gestational diabetes for their high blood sugar levels would provide worthwhile benefits. Several professional organizations advocate screening, but the 2008 guidelines of the U.S. Preventive Services Task Force concluded there is insufficient evidence to support screening for and treatment of gestational diabetes.

Against this background, the MFMU Network launched a clinical trial to determine if treating mothers for mild gestational diabetes would reduce infant deaths and birthrelated complications. A total of 958 women between 24 and 31 weeks of pregnancy were randomized, with 485 receiving treatment (including dietary changes, self blood glucose monitoring and insulin if necessary) and 473 in the untreated group.

There were no infant deaths in the study and no significant differences between the two groups in terms of babies born with problems such as hypoglycemia, hyperbilirubinemia, neonatal hyperinsulinemia and birth trauma.

However, there were significantly fewer babies in the treatment group to experience unusually large size (7.1 percent vs. 14.5 percent), high birth weight (5.9 percent vs. 14.3 percent), shoulder damage during birth (1.5 percent vs. 4.0 percent) or to require cesarean delivery (26.9 percent vs. 33.8 percent).

In addition, Thorp said, “Its especially intriguing that mothers in the treatment arm gained less weight during pregnancy, experienced fewer preterm births and had fewer cases of preeclampsia than mothers in the untreated group.” Preeclampsia is a syndrome marked by a sudden increase in the blood pressure of a pregnant woman after the 20th week of pregnancy, which can be fatal or lead to longterm health problems for mother and baby.

The study concludes that “these findings confirm a benefit to the identification and treatment of women with mild carbohydrate intolerance during pregnancy.”

People with dementia, carers and doctors are not getting the support they need to deal with the ethical issues they facea new report from the Nuffield Council on Bioethics reveals.

The authors call for better training for doctors, nurses and professional carers and emphasise the responsibility we all have to support people with dementia to live well.

The report highlights that its not just the big decisions but also the ordinary things that cause distress, such as whether people with dementia should be given the freedom to carry on with potentially risky activities like cooking or driving. The report also looked at the acceptability of lying to people with dementia if it is seen to be for their benefit.

Neil Hunt, Chief Executive, Alzheimers Society says,

This report provides compelling evidence of the need for better public understanding of dementia, more support and greater investment in research.

Families, carers and professionals face a range of complex and distressing ethical issues when caring for a person with dementia. Decisions can be hugely emotional and there are no right or wrong answers. The Nuffield council recognises the need to combat stigma and emphasises how important it is to value the person with dementia and treat families as partners in care.

One in three people over 65 will die with dementia. We need to ensure that carers are supported in making difficult ethical decisions and people with dementia are involved in this process wherever possible.

Sue Baker, who has a father with Alzheimers disease has faced her own ethical dilemmas.

As a carer its pretty normal to have to make difficult choices on a regular basis but that doesnt make it any easier. When Dad was diagnosed with bowel cancer we chose not to tell him as having Alzheimers disease was already more than enough for him to deal with and it would only have caused unnecessary pain. You have to look at your individual situation and act with the best interests of the person with dementia in mind.

The report was released following a years work involving consultations with experts, including Alzheimers Society. Alzheimers Society worked with its members to feed the experiences and views of people with dementia and their carers into this process.

Notes

Summary of key points from the report

Dementia is a medical condition but dementia services are often classed as social and not made available until a crisis point occurs. People with cancer would not be expected to wait for a crisis point and neither should people with dementia.

People should have access to good quality assessment and support from the moment they or their families become concerned about symptoms

Families should be treated as partners in care by professionals.

Risk assessments should be replaced by riskbenefit assessments that take into account the quality of life of the person with dementia.

The Equality & Human Rights Commission should highlight the legal duties of shops and restaurants to ensure people with dementia can use their services.

Greater guidance is needed on how to apply mental capacity legislation and the process of appointing a welfare attorney should be easy and free.

There should be more funding for dementia research, including research into how people with dementia can be supported to live well.

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Less than half of men and women in Ontario who may be suffering from depression see a doctor to treat their potentially debilitating condition, according to a new womens health study by researchers at St. Michaels Hospital and the Institute for Clinical Evaluative Sciences (ICES). Whats more, many hospitalized for severe depression fail to see a doctor for followup care within 30 days of being discharged, and many head to hospital emergency departments for care. The findings suggest the need for a comprehensive care model involving a multidisciplinary team of healthcare professionals, including family doctors and mental health specialists, to help women and men and better manage depression and improve their quality of life.

“As a leading cause of diseaserelated disability among women and men, depression puts a tremendous emotional and financial burden on people, their families and our healthcare system,” says Dr. Arlene Bierman, a physician at St. Michaels Hospital and principal investigator of the study Project for an Ontario Womens Health EvidenceBased Report (POWER). “Many Ontarians with depression are not treated for their condition and those who are often receive less than desired care. While there is a lot that is known about how to improve depression, we need to apply this to our work with patients if we want to improve the diagnosis and management of depression. “This involves better coordination among primary care and mental healthcare professionals in both community and hospital settings,” added Dr. Bierman, a researcher at ICES.

Nearly half a million Ontarians, aged 15 and older, suffer from depression. Worldwide, an estimated 154 million people are afflicted by the condition, which is responsible for lost productivity, increased disability claims and greater use of healthcare services.

Key findings of the POWER study released today include Less than 50% of men and women with depression visited a doctor for care for their condition

33% of men and women discharged from hospital for severe depression did not see a doctor for a followup visit within 30 days

17% visited a hospital emergency room within 30 days of discharge from hospital while about 8% were readmitted to hospital

Many older adults started on antidepressant medication did not receive the recommended number of followup visits to manage their condition.

The lack of coordinated care for patients suggests the need for a collaborative caremodel involving a team of healthcare professionals, including mental health professionals and primary care providers. “Research shows that patients cared for using a collaborative model are more likely to see improvement in symptoms, are able to better manage their depression and avoid multiple visits for emergency care,” said Dr. Elizabeth Lin, lead author of the chapter and a research scientist at the Centre for Addiction and Mental Health (CAMH). A study by CAMH released earlier this year also found collaborative care to be a less costly and more effective way of providing mental health treatments for people on shortterm disability leave for a psychiatric disorder.

The study titled POWER (the Project for an Ontario Womens Health EvidenceBased Report), is funded by Echo Improving Womens Health in Ontario, an agency of the Ontario Ministry of Health and LongTerm Care. It is the first study in the province to provide a comprehensive overview of womens health in relation to gender, income, education, ethnicity and geography. The findings are detailed in the report titled Depression the third to be released this year as part of the study. Findings can be used by policymakers and healthcare providers to improve access, quality and outcomes of care for Ontario women.

“The findings clearly support the need to reevaluate the treatment of depression in Ontario,” says Pat Campbell, CEO, Echo Improving Womens Health in Ontario. “We need to provide better access and delivery of more appropriate and effective courses of care. The POWER Study makes a strong case for the adoption of collaborative care models a key finding that can help inform system planning, program planning and policy development.”

For more information on the POWER Study and its partners visit powerstudy.ca. Other findings from the study will be released later this year.

Dr. Arlene Bierman is a researcher in the Keenan Research Centre at the Li Ka Shing Knowledge Institute of St. Michaels Hospital, a scientist at ICES and Echos Ontario Womens Health Council Chair in Womens Health at St. Michaels Hospital and the University of Toronto (Lawrence S. Bloomberg Faculty of Nursing).

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Julie Saccone

Children born to women taking antidepressants in early pregnancy have a small but important increased risk of septal heart defects (a defect in the wall dividing the right side of the heart from the left side), concludes research published on bmj.com today.

Depression affects up to 20% of pregnant women and the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy is common and increasing. However, medical treatment must balance the health of the mother with potential adverse effects to the developing baby.

Until 2005, most studies of SSRIs found no link with major malformations, but recent studies have indicated an increased prevalence of congenital heart defects. This led to a warning by the US Food and Drug Administration in 2005 about the use of the drug paroxetine during pregnancy.

So a team of researchers investigated the association between SSRIs taken in the first trimester of pregnancy and major malformations in over 400,000 children born in Denmark between 1996 and 2003.

Potential confounding factors, including maternal age and smoking, were taken into account.

However, an increased risk of septal heart malformations was found for children of women who used the drugs sertraline and citalopram, but not fluoxetine.

Exposure to more than one type of SSRI was associated with a fourfold increase in septal heart defects, suggesting that simultaneous use of different SSRIs or a change in type of SSRI during early pregnancy may be problematic, say the authors.

Putting these figures into context, the authors show that the absolute differences in heart defects were low. For example, septal heart defects occurred in 2,315 (0.5%) of unexposed children, 12 (0.9%) of SSRI exposed children, and 4 (2.1%) of children exposed to more than one type of SSRI.

The number needed to harm was 246 for women using one type of SSRI in early pregnancy. In other words, one child for every 246 children exposed was likely to suffer a septal heart defect. The corresponding number needed to harm for children of women using more than one type of SSRI was 62.

Future studies, with much larger sample sizes, are needed to further investigate potential associations with more severe malformations, conclude the authors.

These results suggest that the absolute risk for individual pregnant women is very low, says Professor Christina Chambers from the University of California San Diego, USA, in an accompanying editorial. She urges both doctors and patients to carefully weighup the small risks associated with SSRIs against those linked with undertreatment or no treatment.

Link to paper
Link to editorial

The EPA must acknowledge the full extent of the uncertainty in its estimation of biofuels lifecycle greenhouse gas emissions and ensure that biofuel technologies are not preemptively disqualified from participation in the Renewable Fuel Standard program. The Biotechnology Industry Organization (BIO) released official comments on the Environmental Protection Agencys (EPA) proposed rule and draft regulatory impact analysis for the Renewable Fuel Standard.

Brent Erickson, executive vice president of BIOs Industrial & Environmental Section, stated, “EPAs proposed methodology yields highly uncertain estimates of biofuels affect on international land use change, due in part to starting assumptions about future crops productivity and land constraint, causality, and the role of other countries land use policies. EPA must acknowledge the limitations of the current state of the science of estimating international land use change and not preemptively disqualify biofuels from the program unless they are clearly demonstrated to exceed the greenhouse gas emission thresholds set in the law. Because of the high degree of uncertainty in the model and the embryonic state of the emerging science, EPA should expressly disclaim any intent to establish precedent in this rulemaking for how international land use change may be measured under a different regulatory program.

“Technology innovation is occurring at a rapid rate across the biofuels industry, even as petroleum exploration pursues more environmentally questionable sources of oil. EPA has already recognized the contributions biotechnology makes to a “best case scenario” for future conventional biofuel production. The agency should also recognize the contributions biotechnology can make in continuing to increase crop yields, decrease fertilizer inputs, increase drought tolerance and lower the overall carbon footprint of biofuel feedstocks.

“EPAs framework for categorizing biofuel production technologies is too inflexible. A better approach would be to allow biofuel producers to estimate the carbon footprint for their plant based on specific data plugged into a flexible, technology neutral analysis tool that can account for future improvement and innovation.

“Because commercial development of advanced biofuels has been slowed by the current recession as investment in new technologies has declined in all sectors of the economy rapid implementation of the rule, increased transparency of the methodology, and expedited consideration of new pathways is vital. Finally, EPA should take great care in implementing the cellulosic biofuel waiver and associated credits or allowances. Cellulosic volumes under the RFS should be set prudently and allowances should not displace volumetric requirements for blending all biofuels, since the purpose of the renewable fuel standard is to increase blending of renewable fuel. Failure to effectively use the waiver provision and structure the RIN allowances correctly will lead to market instability.”

A new study of New York State data finds that the number of women opting for surgery to remove the healthy breast after a cancer diagnosis in one breast is rising, despite a lack of evidence that the surgery can improve survival. The study also finds that despite extensive press coverage of women who choose to have both breasts removed because of a strong family history of cancer, the rate of this surgery is relatively low and has changed little in the last decade. The study appears in Cancer, a peerreviewed journal of the American Cancer Society.

Prophylactic mastectomy, the removal of a noncancerous breast, is one method for reducing a womans risk of developing breast cancer; however, there is little information available on the prevalence of prophylactic mastectomies for preventing breast cancer among highrisk women or on the prevalence of the surgery to prevent tumors in the healthy breast among women whose cancer is limited to one breast.

Researchers led by Stephen B. Edge, M.D., FACS, of the Roswell Park Cancer Institute in Buffalo, NY, examined the frequency of prophylactic mastectomies in New York State between 1995 and 2005 using mandated statewide hospital discharge data combined with data from the state cancer registry. They identified 6,275 female New York residents who underwent prophylactic mastectomies. Eightyone percent of the women had been diagnosed with cancer in one breast, while 19 percent had no personal history of breast cancer.

The researchers found that the number of prophylactic mastectomies increased during the time period, particularly among women with cancer in one breast. Over the 11year study period, the prevalence of these contralateral mastectomies more than doubled. The prevalence of bilateral prophylactic mastectomies among women with no personal history of breast cancer increased only slightly.

“These data from New York are the only data on a large population of women that examine the use of bilateral prophylactic mastectomy,” said Dr. Edge. “These data demonstrate that prophylactic mastectomy is an uncommon procedure that is performed most commonly on women with a personal history of breast cancer. Although the total number of prophylactic mastectomies performed per year was small, it appears that the use of the surgery is increasing.” In addition, he noted that women with breast cancer should have careful counseling regarding benefits and risks before proceeding with prophylactic mastectomy of the other breast.

Article “Surveillance of prophylactic mastectomy Trends in Use from 19952005.” Colleen C. McLaughlin, Patricia P. Lillquist, and Stephen B. Edge. Cancer; Published Online September 28, 2009 (DOI 10.1002/cncr.24623); Print Issue Date December 1, 2009.

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David Sampson

After 56 years of discomfort, embarrassment, and even pain, Maureen Dillon was finally able to go out in public with only one layer of makeup on. She felt beautiful for the first time since adolescence. She jumped in a pool without worrying about her makeup washing off and revealing a strawberrycolored cheek and nose.

Dillon had lived with port wine stains since birth, and they became darker and brought more distress as the years went on.

After dealing with blood vessel clusters and papules, swelling and infections, Dillons family doctor sent her to see Jeffrey Orringer, M.D., director of the Cosmetic Dermatology and Laser Center at the University of Michigan Health System. Orringer used lasers that, over eight treatments, removed Dillons port wine stains.

Three of every 1,000 children born has a port wine stain, which is made up of numerous dilated vessels in a localized part of the skin. They can occur anywhere on the body, but most laser treatment patients have port wine stains on the face or neck.

“There are lots of theories about why port wine stains develop, but the truth is that no one really knows why a child is born with a port wine stain,” Orringer says.

Even though he cannot explain why Dillon or anyone else gets the vascular birthmark, he has good odds of making them better with the laser therapy 75 percent to 80 percent of patients have their port wine stain lightened by at least 50 percent, and the mark disappears completely in 15 percent to 20 percent of patients.

“When this type of laser therapy is performed by an experienced physician, risks are really very low,” Orringer says. The combination of stateoftheart lasers with experienced anesthesia doctors makes the treatments essentially painfree for children undergoing the procedure, he added. Adults generally tolerate the treatments in the clinic setting without the need for anesthesia.

Treatments typically take just a few minutes. The patient reclines in a chair, wearing goggles to protect the eyes, while the doctor uses the laser in small circles to reach the entire surface of the port wine stain. Bruising occurs for up to two days after each treatment. Dillon said the look reminded her of black currant jelly. When the bruising wears off, the strawberrycolored port wine stain is not there either.

“It was just amazing,” Dillon said. She no longer requires the antibiotics or prednisone that she needed for infections and swelling from the birthmark.

Orringer recommends that those with port wine stains seek treatment early in life as they normally worsen over time; however, he has also treated older patients with great results.

Resources

Port wine stains in children
Cosmetic Dermatology and laser center site

Teva Pharmaceutical Industries Ltd. (Nasdaq TEVA) announced that the U.S. District Court for the Southern District of Indiana has issued a decision invalidating two patents listed in the FDAs Orange Book for Eli Lillys Evista® (raloxifene hydrochloride) Tablets in litigation concerning Tevas abbreviated new drug application to market a generic version. The court found these patents to be invalid for lack of written description.

In the same opinion, the Court rejected Tevas challenges to four earlier expiring patents, which claim the use of raloxifene for the prevention or treatment of osteoporosis and the dosages of raloxifene for such treatment, and found that Tevas generic raloxifene tablets infringe those other patents. Based on this ruling, the Court enjoined Teva from commencing the commercial launch of generic raloxifene hydrochloride tablets prior to the expiration date of those patents.

Teva plans to appeal the decision, which if affirmed, would prevent Teva from launching its product until March 2, 2014.

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