Latest Research

July 6, 2007

A summary of the "must-read" articles from the journals in that pile on your desk.

Small Family Size Should Be Factor in BRCA Testing

Study shows limited family structure increases risk for BRCA mutation by 2.8-fold

Women without a family history of breast cancer but who have a limited family structure may need to be considered for genetic testing, according to a report in the June 20 issue of the Journal of the American Medical Association.

Jeffrey Weitzel, M.D., of City of Hope in Duarte, Calif., and colleagues analyzed prospectively collected data from 1,543 women seen at high-risk clinics for BRCA gene testing and genetic cancer risk assessment. The researchers determined if BRCA mutations were more prevalent in single cases of early onset disease in families with limited family structure, defined as fewer than two first- or second-degree female relatives surviving beyond 45 years, than among those with adequate family structure.

BRCA mutations were found in 13.7 percent of limited family structure cases, which represented half of the cohort, versus 5.2 percent of those with adequate family structure. Those with limited family structure had a 2.8-fold increased risk for harboring a BRCA mutation.

"Studies such as that by Weitzel and colleagues that highlight the limitations of these predictive tools are critical to understand how best to incorporate quantitative models more effectively into the practice of genetic risk assessment and preventive medicine," write Noah Kauff, M.D. and Kenneth Offit, M.D., of Memorial Sloan-Kettering Cancer Center in New York City, in an accompanying editorial.

AbstractFull TextEditorial

Handful of Drugs Widely Covered in Medicare Part D

Study findings may assist clinicians in choosing affordable drugs for most patients

A review of Medicare Part D drug plans has identified a handful of widely covered prescription drugs in seven common drug classes that have low co-payments, according to a report in the June 20 issue of the Journal of the American Medical Association. Not all generic drugs and few brand-name drugs are widely covered by insurance plans (median co-payment of $53) so physicians should check before prescribing, the authors suggest.

Due to the growing diversity of Medicare Part D plans, Chien-Wen Tseng, M.D., of Pacific Health Research Institute in Honolulu, Hawaii, and colleagues reviewed 72 California and 43 Hawaii Part D formularies to identify widely covered, affordable drugs in eight drug classes: angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers, calcium channel blockers, loop diuretics, selective serotonin reuptake inhibitors, statins, and thiazide diuretics.

Seven of the eight classes had at least one widely covered drug, defined as those covered by at least 90 percent of formularies with a co-payment of $35 or less. For example, four ACE inhibitors (benazepril, captopril, enalapril and lisinopril) were covered by 96 percent of plans. Using more stringent criteria of at least 95 percent coverage and a maximum $15 co-payment, at least one drug was still included in the seven classes. Coverage for drugs in California formularies ranged from 7 percent to 100 percent overall while 73 percent of generic drugs and 6 percent of brand-name drugs were widely covered.

"Knowing which drugs are widely covered would assist clinicians in prescribing, since not all generic drugs were widely covered," the authors write. "Clinicians should know that few brand-name drugs are widely covered and check coverage before prescribing."

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Therapy for Malaria Still Effective Despite Resistance

Study shows two-dose sulfadoxine-pyrimethamine reduces malaria in pregnant women in endemic regions

In malaria-endemic regions where resistance to sulfadoxine-pyrimethamine is growing, a two-dose intermittent preventive therapy (IPT) program continues to provide substantial clinical benefit in terms of preventing malaria in HIV-negative pregnant women, according to a systematic review of the literature in the June 20 issue of the Journal of the American Medical Association.

Feiko O. ter Kuile, M.D., Ph.D., of Liverpool School of Tropical Medicine in Liverpool, England, and colleagues identified nine trials of IPT with sulfadoxine-pyrimethamine during pregnancy in Africa and matched those by year and location to treatment studies of sulfadoxine-pyrimethamine among symptomatic children to determine the effect of IPT in this population. Pregnant women and children carry most of the malaria burden in endemic countries.

IPT was found to reduce placental malaria by 52 percent in women during their first or second pregnancy, according to four trials comparing IPT to case management or placebo. Anemia and low birth weight pregnancies were also lower. Among HIV-positive women, monthly IPT reduced placental malaria by 66 percent compared with the single two-dose regimen, suggesting that more frequent dosing is required in this group.

"Reserving the use of sulfadoxine-pyrimethamine for IPT during pregnancy and for infants may reduce drug pressure and may prolong longevity of this valuable drug," the authors write. Since most countries are taking this course, future research may require the use of molecular markers to monitor sulfadoxine-pyrimethamine.

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Consent to Therapy Affected by How Benefits Presented

Patients presented with number needed to treat information more likely to consent to therapy

The way the potential benefits of a drug are presented to a patient can have a significant impact on their willingness to begin therapy, researchers report in the June 19 issue of the Annals of Internal Medicine. The number needed to treat (NNT) method seems to result in higher consent rates.

Peder Halvorsen, M.D., from the University of Southern Denmark in Odense, Denmark, and colleagues sought to test the hypothesis that laypersons understand a drug's potential benefit as postponement of an adverse event better than the concept of NNT. In this cross-sectional, random allocation survey, subjects responded to hypothetical scenarios involving drug regimens to reduce heart attacks or hip fractures given real data from clinical trials but presented differently.

Overall, patients who reported that they understood the treatment effect were more likely to consent to therapy. In the heart attack scenario, 93 percent of respondents presented with NNT outcome consented to treatment as did 82 percent who were presented with benefits as a large postponement for some patients, and 69 percent who were presented with short postponements for all patients. For hip fracture scenarios, the consenting percentages were 74, 56 and 34 percent, respectively.

The findings "remind us about framing effects and show how they could affect decisions about preventive interventions," according to Harold Sox, M.D., of the American College of Physicians, in an accompanying editorial. "Talking time is more than a pleasurable exercise of clinical skills. It can change people's lives. As such, we must pay attention to its nuances."

AbstractFull TextEditorial

Erythema Migrans Can Vary, Making Diagnosis Difficult

Symptoms and sources of early sign of Lyme disease vary widely

Erythema migrans, one of the most common early signs of Lyme disease, can be a tricky diagnosis as patients often don't recall a tick bite and can present with multiple lesions or rashes without central clearing, researchers report in the June 20 issue of the Journal of the American Medical Association.

Carrie D. Tibbles, M.D., and Jonathan A. Edlow, M.D., of Beth Israel Deaconess Medical Center in Boston, report on their search of articles on erythema migrans published since 1966, including 8,493 patients from 32 European studies, 20 U.S. studies, and one from both regions.

Overall, few patients recalled being bitten by a tick. While a solitary bite was the most common presentation (81 percent U.S.; 88 percent Europe), some patients had multiple lesions. The extent of central clearing varied. Asian and European cases of the disease tended to have larger lesions than in the United States, and symptoms were more chronic and less systemic. In non-endemic southern states of the United States, patients were more likely to have a shorter incubation period, central clearing and a history of tick bites.

The authors detailed 12 diagnostic mimics of erythema migrans including contact dermatitis, spider bites and tinea. "There is no single element in the history or physical examination that is highly sensitive by itself for the diagnosis of erythema migrans," the authors conclude.

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Hepatitis B Drug Can Block HIV-1 Replication

Entecavir monotherapy can generate viruses resistant to HIV-1 drugs in co-infected patients

Contrary to previous evidence, the hepatitis B drug entecavir can block the replication of HIV-1 in patients infected with both viruses, and monotherapy can generate HIV variants that are resistant to antiretroviral drugs, such as lamivudine, according to study findings published in the June 21 issue of the New England Journal of Medicine.

Chloe L. Thio, M.D., from Johns Hopkins University School of Medicine in Baltimore, and colleagues describe the cases of three individuals co-infected with HIV-1 and hepatitis B virus (HBV) who were treated with entecavir for HBV.

The researchers found that entecavir consistently reduced HIV-1 RNA levels by 10-fold and could partially inhibit HIV-1 replication in vitro. One patient who was treated with entecavir alone accumulated HIV-1 variants with the lamivudine-resistant mutation M184V, which in vitro studies showed also conferred resistance to entecavir.

"Until more is known about HIV-1-resistance patterns and their selection by entecavir, caution is needed with the use of entecavir in persons with HIV-1 and HBV co-infection who are not receiving fully suppressive antiretroviral regimens," Thio and colleagues conclude.

AbstractFull TextEditorial

Estrogen Reduces Calcium in Coronary Artery Plaque

Still, hormone-replacement therapy should not be used to prevent heart disease in women, experts say

Relatively young postmenopausal women in their 50s who receive estrogens after a hysterectomy have less calcified plaque in their coronary arteries than those who take a placebo, according to the results of a randomized trial in the June 21 issue of the New England Journal of Medicine.

JoAnn E. Manson, M.D., from Brigham and Women's Hospital, Harvard Medical School in Boston, and colleagues randomized 1,064 hysterectomy patients (aged 50 to 59) to placebo or 0.625 mg conjugated equine estrogens per day. Coronary artery calcium was measured by computed tomography of the heart after a mean of 7.4 years of treatment and a mean of 1.3 years after the trial was completed.

The researchers found that women who had taken estrogen had significantly less coronary artery calcium. An intention-to-treat analysis showed that estrogen reduced coronary calcium by 42 percent, with a reduction of 61 percent in women who were at least 80 percent adherent to their estrogen treatment.

The study "should prove somewhat reassuring to women who have recently undergone menopause and are considering hormone-replacement therapy for relief of symptoms," Michael E. Mendelsohn, M.D., and Richard H. Karas, M.D. Ph.D., from Tufts University School of Medicine in Boston, write in an accompanying editorial. "It remains important, however, to continue to emphasize that hormone-replacement therapy should not be considered as a strategy to prevent cardiovascular disease in women."

AbstractFull TextEditorial

MS Progression Slower in Children Than Adults

But childhood-onset patients irreversibly disabled at a younger age

Childhood-onset multiple sclerosis progresses more slowly than adult-onset disease, but childhood-onset patients become irreversibly impaired at a younger age, researchers report in the June 21 issue of the New England Journal of Medicine.

Christian Confavreux, M.D., of the Hopital Neurologique Pierre Wertheimer in Lyon-Bron, France, and colleagues compared data on 394 patients who developed multiple sclerosis at or before age 16 with 1,775 patients diagnosed after 16.

On a scale from 0 to 10, disability level was pegged at 7 for walking up to 10 meters without resting, 6 for walking up to 100 meters with help, and 4 for walking more than 500 meters without support.

The researchers estimated 28 years between onset to secondary progression (at median age 41) in childhood-onset multiple sclerosis patients. Median time between onset and disability scores of 7, 6 and 4 were 37.0, 28.9, and 20 years. More women than men had childhood-onset disease, which took a decade longer to become irreversible, but occurred in patients a decade younger.

"Patients with childhood-onset multiple sclerosis take longer to reach states of irreversible disability but do so at a younger age than patients with adult-onset multiple sclerosis," the authors conclude.

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In 21 U.S. States, Medical Standards Locally Determined

Rule dating back to 1880 allows standard of care to be decided by what is the local norm

In contrast to medical school training, licensing and board certification, which are determined according to national requirements, standards of medical practice are locally determined in 21 U.S. states, creating uncertainty over what constitutes medical malpractice, according to a commentary published in the June 20 issue of the Journal of the American Medical Association.

Michelle Huckaby Lewis, M.D., J.D., of the Johns Hopkins Berman Institute of Bioethics in Baltimore, and colleagues explain that the locality rule was created in the 1880s, and arose from the lack of educational opportunities for rural doctors compared to their urban counterparts. In small communities with only one or two doctors, the law in effect created immunity from malpractice suits.

The authors argue that in the context of modern medical education and practice, the locality rule is becoming harder to justify because it allows substandard doctors to set the level of acceptable care, education is now standardized and all physicians can upgrade their knowledge using modern technology.

"Whereas this rule protected rural physicians in the 1800s who didn't have access to the kind of medicine available in larger cities, it now works to create uncertainty for physicians, especially those who practice in more than one legal jurisdiction, which can translate to less than adequate patient care," said Huckaby Lewis, in a statement.

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Mixed Results from Studies of Acupuncture for Knee Pain

Clinical benefits differ depending on comparator

Acupuncture may have real benefits on pain and function in patients with knee osteoarthritis, some of which may be due to placebo effects, according to a meta-analysis in the June 19 issue of the Annals of Internal Medicine.

Eric Manheimer, M.S., from the University of Maryland School of Medicine in Baltimore, and colleagues combined data from nine randomized trials of acupuncture versus sham or waiting-list control groups that lasted six weeks or longer.

The investigators found that, compared with a sham control, acupuncture resulted in clinically irrelevant improvements in pain and function in both the short and long term. However, trial results were heterogeneous. Compared with waiting-list controls or standard-care groups, acupuncture patients reported clinically relevant short-term improvements in pain and function.

"Our findings of no or minimal clinically relevant effects of acupuncture compared with sham but marked clinically relevant effects of acupuncture compared with a waiting-list or usual-care control group suggest that placebo effects or the elicitation of the meaning response are largely responsible for the effects of acupuncture," the authors conclude. The short-term improvements in pain and function compared with sham suggest that acupuncture does have some biological effect, they add.

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Risk Factors for Myeloma Progression Identified

Time since diagnosis, proportion of bone marrow plasma cells, serum monoclonal protein important

The risk of smoldering (asymptomatic) multiple myeloma progressing to symptomatic disease is influenced by the time since diagnosis as well as the proportion of bone marrow plasma cells and level of serum monoclonal protein at diagnosis, according to a report in the June 21 issue of the New England Journal of Medicine.

Robert A. Kyle, M.D., and colleagues from the Mayo Clinic in Rochester, Minn., retrospectively examined prognostic factors and outcomes in 276 patients with smoldering multiple myeloma seen at their institution over a 26-year period.

The researchers found that 59 percent of patients developed symptomatic multiple myeloma or amyloidosis after 2,131 cumulative person-years of follow-up. The risk of progression was highest during the first five years after diagnosis at 10 percent per year and decreased with time, with a cumulative probability of 73 percent after 15 years. The risk of progression was associated with the proportion of bone marrow plasma cells and level of serum monoclonal protein at diagnosis, which were used to stratify patients into three risk groups.

"Our study shows that the overall risk of progression in smoldering multiple myeloma is greatly influenced by the time elapsed since diagnosis," Kyle and colleagues conclude. "The risk of progression from smoldering multiple myeloma to symptomatic disease is related to the proportion of bone marrow plasma cells and the serum monoclonal protein level at diagnosis."

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Age at Implant Affects Defibrillator Patient Outcome

Some non-cardiac conditions hike risk after ICD implantation

Increased age at implantation and non-cardiac comorbidities affect the risk of mortality in patients with an implantable cardioverter-defibrillator (ICD), researchers report in the June 26 issue of the Journal of the American College of Cardiology.

Douglas Lee, M.D., Ph.D., of St. Michael's Hospital in Toronto, Canada, and colleagues investigated three years of medical data on comorbidities among 2,467 Canadians who died up to five years after receiving ICDs. Mean age at implant was 59.8 for 523 women and 63.2 for 1,944 men.

The researchers found death rates of 7.8 percent one year after implant and 14 percent at two years. Several common non-cardiac conditions including peripheral vascular disease, renal disease and pulmonary disease increased the death risk. Mortality risk increased with age at implant. Gender was not a factor.

In an accompanying editorial, Sumeet Chugh, M.D., of Oregon Health & Science University in Portland, Ore., and colleagues note that the "findings emphasize the need for a strong consideration of non-cardiac comorbidities in the care of a burgeoning and likely aging ICD population."

AbstractFull Text (subscription or payment may be required)Editorial

Home-Visit Program Has Some Benefits for Teen Mothers

Program leads to better parenting skills, greater likelihood of staying in school

A community-based home-visiting program for adolescent mothers may help improve their parenting skills and increase their odds of staying in school. However, it doesn't improve other outcome measures, such as repeat pregnancy, according to study findings published in the May/June issue of the Annals of Family Medicine.

Beth Barnet, M.D., of the University of Maryland School of Medicine in Baltimore, and colleagues randomly assigned 84 low-income black adolescent mothers, aged 12 to 18, to be part of a home-visit group or a control group. Of these, 83 percent completed year one or year two follow-up assessments, or both.

The researchers found that the home-visit group scored an average of 5.5 points higher than the control group on the Adult-Adolescent Parenting Inventory and that the home-visit group was 3.5 times more likely to continue to attend school. They also found that there were no significant group differences for repeat pregnancy, depression or linkage with primary care.

"It is possible that other important outcomes, such as repeat pregnancy and depression, could be altered with greater coordination of care," the authors conclude. "Community-based home-visiting programs and primary care practices may achieve greater benefits if they work together to develop and test explicit mechanisms and implementation systems that coordinate care for high-risk adolescents."

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American Heart Association Issues Hypertension Guidelines

Statement rounds up best practice on treatment and blood pressure reduction

The American Heart Association has issued new guidelines for the treatment of hypertension to prevent coronary artery disease based on the best available data for diastolic and systolic targets, comorbidities and antihypertensive drugs. The guidelines are published in the May 29 issue of Circulation: Journal of the American Heart Association.

Clive Rosendorff, M.D., Ph.D., chair of the American Heart Association in Dallas, Texas, and colleagues note that aggressive blood pressure lowering is appropriate for the primary prevention of heart disease in patients with diabetes, chronic renal disease or other heart disease risk factors, with a target of less than 130/80 mm Hg.

However, in patients with elevated diastolic blood pressure, heart disease and signs of myocardial ischemia, more caution is needed and pressure should be lowered slowly, according to the guidelines. The choice of drugs is controversial, but most patients will need two medications to achieve their target. If pressure is greater than 20/10 mm Hg above goal at the outset, patients can be started on two drugs.

"Studies have shown equivalence of benefit of angiotensin converting enzyme inhibitors and the angiotensin II receptor blockers candesartan or valsartan in heart failure. Either class of agents is effective in lowering blood pressure," the authors write.

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No Advantage to High-Dose Vitamin A Supplementation

In vitamin A-deficient areas, the current WHO protocol does not need to be changed

The current World Health Organization protocol on the administration of vitamin A supplements in areas with moderate vitamin A deficiency does not need to be changed in favor of high-dose supplementation, according to a report published in the June 23 issue of The Lancet.

Andrew M. Prentice, Ph.D., of the London School of Hygiene and Tropical Medicine in London, U.K., and colleagues conducted a randomized, controlled trial of 220 mother-infant pairs in rural Gambia who were given either the high dosage recommended by the International Vitamin A Consultative Group or the dose recommended by the WHO.

At the 12-month follow-up stage, both doses produced the same results in terms of maternal and infant plasma vitamin A, H pylori infection, pneumococcal carriage and gut epithelial integrity. The high-dose group produced more clinic attendances in the first six months.

"Our results do not lend support to the proposal to increase the existing WHO standard dosing schedule for vitamin A in areas of moderate vitamin A deficiency," the authors conclude. "Caution is urged for future studies because trials have shown possible adverse effects of higher doses of vitamin A, and potential negative interactions with the expanded program on immunization vaccines."

AbstractFull Text (subscription or payment may be required)Editorial

Gene Therapy for Parkinson's Completes Phase I Trial

Delivery of glutamic acid decarboxylase gene suggested to be safe and well tolerated

Gene therapy for Parkinson disease using an adeno-associated virus-borne glutamic acid decarboxylase gene was safe and well tolerated in a phase I trial, and shows promise as a treatment for neurodegenerative disease, according to study findings published in the June 23 issue of The Lancet.

Matthew J. During, M.D., of the Ohio State University School of Medicine in Columbus, and colleagues conducted a trial enrolling 11 men and one woman with Parkinson disease, who were given glutamic acid decarboxylase gene via the adeno-associated virus. High, medium and low doses were given to four patients each.

Clinical assessments were conducted at baseline and after one, three, six and 12 months. Three months after gene therapy, patients showed significant improvements in motor Unified Parkinson's Disease Rating Scale scores, which persisted for up to a year. Thalamic metabolism was reduced in the treated hemisphere. There were no deaths, adverse events or drop-outs associated with the therapy.

"The promise of gene therapy has yet to be fulfilled; however, the ability to alter cellular function genetically remains a powerful potential opportunity for treatment of various devastating diseases," the authors write. "Our results show that adeno-associated virus-mediated gene transfer can be done safely in the human brain, with no evidence of substantial toxic effects or adverse events," they conclude.

AbstractFull Text (subscription or payment may be required)Editorial

Steroid Worsens Amiodarone-Linked Thyroid Dysfunction

Prednisone associated with worse outcomes

Thyroid dysfunction associated with the anti-arrhythmia drug amiodarone is linked to serious complications in the long term, with worse outcomes in patients who are treated with prednisone, according to a report in the June 19 issue of the Journal of the American College of Cardiology.

Stefan Osswald, M.D., and colleagues from University Hospital in Basel, Switzerland, retrospectively examined the clinical course and predictors of outcome in 84 patients with amiodarone-induced thyrotoxicosis (AIT), of whom 27 were treated with prednisone.

The researchers found that prednisone had no effect on the time to normalization of free thyroxine levels. Morbidity and mortality were high after a median follow-up of 50 months, with 56 percent of patients experiencing complications such as death, heart transplantation, hospitalization, myocardial infarction or stroke. Outcomes were significantly worse in patients treated with prednisone, although problems were not observed until as late as 12 months after diagnosis.

"Patients with AIT have a high event rate during follow-up," Osswald and colleagues conclude. "Importantly, AIT-related problems must be expected late, at a time when thyroid function is under control."

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Antidepressant Linked to Bone Density Loss

Selective serotonin reuptake inhibitors linked to loss of bone density

A popular class of medications used to treat depression in older men and women has been linked to bone density loss that can result in hip fractures and falls, according to two studies published in the June 25 issue of the Archives of Internal Medicine.

Susan Diem, M.D., of the University of Minnesota in Minneapolis, and colleagues sampled the bone mineral density of 2,722 women with an average age of 78.5 of which 198 used selective serotonin reuptake inhibitors (SSRI) for depression. The investigators found an average bone mineral density decrease of 0.82 percent in hip bones of women taking SSRIs, nearly double the 0.47 percent bone loss for those taking tricyclic antidepressants or no medication.

In similar research by Elizabeth Haney, M.D., of Oregon Health & Science University in Portland, Ore., and colleagues, bone density was measured in 5,995 men aged 65 and older, including 160 who used SSRIs, 99 who took tricyclic and 52 who used trazodone antidepressants. The researchers found hip and lumbar spine bone mineral density to be 3.9 percent and 5.9 percent lower, respectively, for SSRI users than for the rest of the cohort group.

An accompanying editorial by Kenneth Saag, M.D., of the University of Alabama at Birmingham, notes that the two studies strengthen previous research pointing to a causal relationship between SSRI use and bone health that should signal caution to physicians prescribing antidepressants. "Analogous to the necessity for using glucocorticoids in persons with certain serious inflammatory disorders, those who truly need SSRIs should continue to receive them despite potential bone concerns," according to the editorial.

The authors disclose that they have received research support from several pharmaceutical companies.

Abstract - DiemFull Text (subscription or payment may be required)Abstract - HaneyFull Text (subscription or payment may be required)Editorial

Doctors' Personal Disclosures May Disrupt Treatment

Recent study suggests more than three-quarters of disclosures deemed useless to patients

Eleven percent of personal disclosures by primary care physicians disrupt patient treatment, and 85 percent are of no use to patients, researchers report in the June 25 issue of the Archives of Internal Medicine. The personal disclosures range from discussing their families, relationships, experiences and emotions, to personal feelings about the patient's diagnosis, and more.

Susan McDaniel, Ph.D., of the University of Rochester School of Medicine and Dentistry in Rochester, N.Y., and colleagues analyzed discreetly recorded transcripts of 113 primary care patient visits.

The researchers found that physician self-disclosures occurred during 34 percent of visits. Some 14 percent of disclosures were answers to a patient inquiry. Almost two-thirds (60 percent) occurred after discussing a patient's feelings, family or symptoms; 40 percent were unrelated. The researchers deemed 85 percent useless to patients; the disclosures were considered disruptive in 11 percent of cases.

"Practicing primary care physicians disclosed information about themselves or their families in 34 percent of new visits with unannounced, undetected, standardized patients," the authors write. "There was no evidence of positive effect of [physician] self-disclosures; some appeared disruptive. Primary care physicians should consider when self-disclosing whether other behaviors such as empathy might accomplish their goals more effectively."

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Survivors of Epidemics Stressed by Lack of Support

Experiences of SARS survivors show need for public health strategies to help people cope with epidemics

Survivors of the severe acute respiratory syndrome (SARS) epidemic in 2003 regained much of their physical health within a year of hospitalization, but showed significant mental stress from being isolated and stigmatized by the unknown disease, according to the results of a study published in the June 25 issue of the Archives of Internal Medicine.

Catherine M. Tansey, M.Sc., of the University Health Network in Toronto, Canada, and colleagues evaluated 117 SARS survivors in a prospective and observational study to determine one-year outcomes of patients and the effects on their informal caregivers. SARS survivors, 67 percent of whom were women with a median age of 42, were interviewed and given a physical exam at three-, six- and 12-month intervals after discharge while caregivers were surveyed at one year on the personal impact of caring for someone with SARS.

The Canadian researchers found that 37 percent of the SARS patients who underwent acute care hospitalization were still reporting such physical health symptoms as fatigue, shortness of breath and inability to sleep one year after discharge, and 33 percent showed significant mental distress from the stigma of having the disease. Caregivers didn't suffer physically but reported high emotional stress and isolation from caring for a family member with SARS. The results point to the need for effective public health strategies to help people cope with epidemics, the study notes.

"Early on in the SARS outbreak, the mode of transmission of the disease was unknown, and all person-to-person contact was minimized," the authors write. "However, some patients reported that health care workers insisted on spending time with and giving emotional support to them, and this helped to ameliorate their feelings of fear, anxiety and isolation."

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Portion Plates Help Obese Patients Shed Pounds

Measuring meal sizes is an effective way for obese patients to manage calories and reduce weight

Obese diabetic patients using portion control tools to measure the amount of carbohydrates, protein and fat consumed at each meal may shed enough weight over six months to reduce some medication usage, according to study findings published in the June 25 issue of the Archives of Internal Medicine.

Sue Pedersen, M.D., of the University of Calgary in Alberta, Canada, and colleagues performed a randomized study involving 130 obese patients with type 2 diabetes who visited a diabetes clinic or were referred by their physicians. Participants were divided into two groups: a control group that received "usual" dietary and weight loss counseling or an intervention group given portion control plates that reduced daily caloric intake by measuring the portion size of food allowed per meal.

The researchers found 16.9 percent of those using portion plates achieved at least 5 percent weight loss at the six-month mark, compared to 4.6 percent in the control group, with similar results in comparing subgroups of patients taking insulin. In addition, 26.2 percent of the intervention group experienced a decrease in use of hypoglycemic medication to control blood sugar, compared to 10.8 percent in the control group.

"Compared with usual care, the portion control tool studied was effective in inducing weight loss," the authors write. "The portion control plate also enabled patients with diabetes mellitus to decrease their hypoglycemic medications without sacrificing glycemic control."

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Terminally Ill Children Dying at Home More Often

Racial differences exist for place of death, however

Children with terminal complex chronic conditions are more frequently spending their last days at home, according to a report in the June 27 issue of the Journal of the American Medical Association. Some racial disparities seem to exist for the place of death, however.

Chris Feudtner, M.D., Ph.D., of The Children's Hospital of Philadelphia, and colleagues used data from the National Center for Health Statistics' Multiple Cause of Death Files to determine if children with complex chronic conditions are dying at home more frequently and to examine if the place of death differs by race.

The investigators found that the proportion of children younger than 19 years of age dying at home from complex conditions increased from 4.9 percent in 1989 to 7.3 percent in 2003. Overall, the odds of dying at home have increased on a yearly basis but the odds for black or Hispanic children dying at home is about 50 percent less than that for white children.

"Medical and other concerned professionals need to ensure that all patients have access to necessary care and that all dialogue and interactions regarding decisions about care -- whether curative, life-extending or palliative -- are built on mutual understanding, trust and respect," the authors write.

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Whites Have Highest Type 1 Diabetes Rates Among Youth

Adolescent minorities have highest type 2 diabetes rates

A nationwide study of diabetes mellitus incidence rates among U.S. youth shows that whites are more likely to have type 1 diabetes while adolescent minority populations are more likely have type 2 diabetes, according to study findings published in the June 27 issue of the Journal of the American Medical Association.

Dana Dabelea, M.D., Ph.D., from the University of Colorado Health Sciences Center in Denver, and members of the SEARCH for Diabetes in Youth Study Group conducted a multiethnic, population-based study of 2,435 U.S. youth (younger than age 20) with newly diagnosed, non-secondary diabetes mellitus, to measure the incidence of disease according to racial background and disease type.

While the overall incidence of diabetes mellitus was found to be 24.3 per 100,000 person-years, the rates for type 1 disease was highest among whites and ranged from 18.6 in the 0-4 year age group to 32.9 for the 10-14 age group. Type 2 diabetes was less frequent but was highest in the 15- to 19-year-old minority groups and ranged from 17.0 to 49.4 per 100,000 person-years.

"There is an urgent need to go beyond studies such as this one by implementing a coordinated approach for childhood diabetes surveillance (i.e., mandated case-reporting)," writes Rebecca B. Lipton, Ph.D., from the University of Chicago, in an accompanying editorial. "Only then can society respond effectively to the serious and increasing challenge of diabetes in youth."

AbstractFull Text (subscription or payment may be required)Editorial

Child Cancer Survivors May Have Adverse Outcomes Later

Radiotherapy associated with highest rate of adverse events

Many childhood survivors of cancer go on to experience significant adverse health effects, especially those who received radiotherapy as part of their treatment, according to a report in the June 27 issue of the Journal of the American Medical Association.

Huib N. Caron, M.D., Ph.D., of Emma Children's Hospital/Academic Medical Center in Amsterdam, the Netherlands, and colleagues conducted a retrospective cohort study of 1,362 five-year survivors of childhood cancer treated between 1966 and 1996 to assess the total burden of adverse health outcomes.

Nearly 75 percent of survivors had at least one adverse outcome during follow-up, with 25 percent having five or more adverse outcomes, many of which were severe. In fact, 40 percent of survivors had at least one severe or life-threatening adverse event. Fifty-five percent of patients receiving radiotherapy reported an adverse event compared with 15 percent of survivors treated with chemotherapy only. Psychosocial/cognitive and orthopedic problems were some of the most common adverse outcomes.

The study provides "provocative data highlighting the excessive and severe morbidity that follows therapy for childhood cancer," write Kevin Oeffinger, M.D., of Memorial Sloan-Kettering Cancer Center in New York City, and a colleague in an accompanying editorial. "It is critically important for physicians to recognize these risks, facilitate risk-based health care, and strive to improve therapy that not only improves cure rates but also reduces long-term morbidity."

AbstractFull Text (subscription or payment may be required)Editorial

Bright Bodies Program Helps Overweight Kids Cut Fat

Program also shows positive benefits on insulin sensitivity

The Bright Bodies Weight Management program may help overweight children reduce body fat and control insulin sensitivity, according to a report in the June 27 issue of the Journal of the American Medical Association.

Mary Savoye, R.D., of Yale University School of Medicine in New Haven, Conn., and colleagues randomized 209 overweight children aged 8 to 16 years, with a body mass index greater than the 95th percentile for age and sex, to either a control group or to the weight management program. Bright Bodies is an intensive, family-based program incorporating exercise, nutrition and behavioral modification.

Children assigned to the weight management program, who received biweekly interventions for six months and then bimonthly thereafter, showed stable overall weight for up to 12 months while reducing their body mass index and total fat composition compared with the control group. The Bright Bodies program also helped reduce homeostasis model assessment of insulin resistance scores.

"The success of the Bright Bodies program undoubtedly relates, in part, to the frequent contacts between families and the professional staff," the authors write. Since the program is associated with substantial expenses, the group intends to perform a cost-benefit analysis next.

AbstractFull Text

SSRIs Are Not Major Teratogens When Taken in First Trimester

Studies show a small increase in absolute risk for some defects and with certain drugs

As a group, selective serotonin reuptake inhibitors (SSRIs) taken during the first trimester of pregnancy do not increase the risk of most birth defects, according to two studies published in the June 28 issue of the New England Journal of Medicine. There may be possible exceptions for particular SSRIs and some rare birth defects, but the absolute risks are small.

In the first study, Carol Louik, Sc.D., from the Slone Epidemiology Center at Boston University, and colleagues examined the association between maternal SSRI use during the first trimester and birth defects in 9,849 infants with birth defects and 5,860 infants without birth defects. The investigators found that there were no significant increases in the risks of craniosynostosis, omphalocele or heart defects associated with SSRIs as a group, although individual SSRIs increased the risk of certain rare birth defects but with a low absolute risk.

In the second study, Jennita Reefhuis, Ph.D., from the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues examined the association between maternal SSRI use during the first trimester and birth defects in 9,622 infants with major birth defects and 4,092 infants without birth defects. The researchers found no increased risk of most birth defects associated with SSRIs as a group, apart from an increased risk of anencephaly, craniosynostosis and omphalocele, though the absolute risks were small, the authors conclude.

"A survey of the aggregate data now available -- positive, negative and equivocal -- makes it clear that neither SSRIs as a group nor individual SSRIs are major teratogens on the order of thalidomide or isotretinoin," Michael F. Greene, M.D., from Massachusetts General Hospital in Boston, writes in an accompanying editorial.

Abstract - LouikFull TextAbstract - ReefhuisFull TextEditorial

Permanent Makeup Can Cause Serious Adverse Reactions

Ink brand associated with most reactions has been recalled

Permanent makeup can result in serious long-term adverse reactions, although the ink brand associated with most of the reactions has since been recalled, according to a letter to the editor in the June 28 issue of the New England Journal of Medicine.

Masja Straetemans, Ph.D., from the U.S. Centers for Disease Control and Prevention in Chamblee, Ga., and colleagues conducted telephone interviews with 92 individuals who had reported inflammation for more than a week after permanent makeup procedures in 2002-2004.

The researchers found that 95 percent of patients reported tenderness, 91 percent reported swelling, 88 percent reported itching and 83 percent reported bumps. Symptoms lasted for 5.5 months to three years. Healing occurred more quickly in patients without a self-reported history of allergy, which in some cases was confirmed through medical records. The percentage of sites with adverse reactions varied depending on the ink brand.

"Our findings show that application of permanent makeup can result in serious, long-term disfiguring reactions," Straetemans and colleagues conclude. "The product line of ink associated with most of the reactions was recalled on September 27, 2004."

AbstractFull Text

Needlestick Injuries Common During Surgeon Training

Injuries often involve high-risk patients and are not reported

Nearly all surgeons in training have had a needlestick injury by their final year of residency. Many of these injuries involve high-risk patients and go unreported, researchers report in the June 28 issue of the New England Journal of Medicine.

Martin A. Makary, M.D., from Johns Hopkins University in Baltimore, and colleagues surveyed 699 surgeons in training at 17 medical centers in the United States about previous needlestick injuries.

The researchers found that 83 percent of surgeons overall reported having had a needlestick injury, with the mean number of injuries increasing from 1.5 in the first year of residency to 7.7 in the fifth year. By the fifth year, 99 percent reported having had an injury, and 53 percent of those involved a high-risk patient. About half of the most recent injuries were not reported to an employee health service, including 16 percent of injuries involving high-risk patients. Lack of time was cited as the reason injuries were not reported in 42 percent of cases.

"Needlestick injuries are common among surgeons in training and are often not reported," Makary and colleagues conclude.

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Prepared jointly by the editors of Medical Economics and HealthDay's Physicians' Briefing (www.physicianbriefing.com)

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