Showing posts with label life. Show all posts
Showing posts with label life. Show all posts

Thursday, December 9, 2010

Oncologists Value Survival Over Quality of Life, Study Finds

For oncologists, drugs that help cancer patients live longer are worth more than drugs that help patients live well, according to research from Duke University's Fuqua School of Business and several health-related centers.

On average, oncologists were willing to prescribe treatments that cost about $245,000 to prolong life for one year, but the cost threshold dropped to about $119,000 per year for treatments that improve quality of life without prolonging patients' lives.

"Oncologists are understandably focused on survival, but they need to pay equal attention to the quality of life people experience during and after treatment," said senior author Peter Ubel, M.D., the John O. Blackburn professor of business administration at Fuqua.

The researchers found a wide range in what cancer doctors considered reasonable treatment costs. The threshold varied from $10,000 to $5 million per quality adjusted life year (QALY), a standard for assessing the cost-effectiveness of medical interventions. The spending thresholds assessed in the study were also measured in QALYs.

The research can be found on Medical Decision Making's website: http://bit.ly/fBIYBP.

The results highlight a critical problem in the struggle to control health care costs, Ubel said. Increasingly, doctors are being asked to consider whether very expensive cancer drugs -- some of which offer only small gains in survival -- are worth prescribing. But according to Ubel, the data on cost-effectiveness comes without guidelines for determining appropriate financial value in cancer care.

"Currently, individual oncologists are left to decide whether the benefits of expensive new drugs justify their costs," said Ubel. "Cancer care spending is unlikely to drop when there is such a broad range in what oncologists consider reasonable."

"The fact that these highly trained, wonderful doctors are confused about the issue suggests we as a society should discuss the cost of cancer care more explicitly. With health care spending emptying patients' pocketbooks, and bankrupting state and federal governments, we need to decide how much we should spend for small improvements in the quantity or quality of patients' lives."

The study results are based on a survey sent to members of the American Society of Clinical Oncology. The 768 physicians who responded considered two hypothetical scenarios involving a patient with metastatic cancer and a year to live.

The first scenario asked the doctor how much benefit, in months of survival gained, a new drug would need to provide for them to prescribe it. The new drug cost $75,000 more than standard treatment. The second scenario asked the doctor to indicate the highest cost at which they would prescribe a medication to improve the quality of life without prolonging survival.

The respondents consistently chose to spend more on life-prolonging treatments than on quality-enhancing treatments.

Additional authors of the study include Michael A. Kozminski and Aleksandra Jankovic of the Center for Behavioral and Decision Sciences in Medicine, University of Michigan Medical School in Ann Arbor, Mich.; Peter J. Neuman of the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center in Boston; and Eric S. Nadler of the Charles Sammons Cancer Center, Baylor University Medical Center in Dallas.

The study was funded by grants from the California Healthcare Foundation and the Tufts Medical Center.

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Thursday, October 15, 2009

FDA Announces Plans for LASIK Quality of Life Project

The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.

The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.

Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.

Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.

Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.

The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.

“This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure,” said Dr. Jeffrey Shuren, acting director of the FDA’s Center for Devices and Radiological Health.

The FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.

Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.

The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.

“Many people in the U.S. undergo LASIK procedures,” said Shuren. “Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law. Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements.”

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Wednesday, August 19, 2009

Life Expectancy at All Time High; Death Rates Reach New Low, New Report Shows

U.S. life expectancy reached nearly 78 years (77.9), and the age-adjusted death rate dropped to 760.3 deaths per 100,000 population, both records, according to the latest mortality statistics from the Centers for Disease Control and Prevention (CDC).

The report, "Deaths: Preliminary Data for 2007," was issued today by CDC's National Center for Health Statistics. The data are based on nearly 90 percent of death certificates in the United States.

The 2007 increase in life expectancy - up from 77.7 in 2006 -- represents a continuation of a trend. Over a decade, life expectancy has increased 1.4 years from 76.5 years in 1997 to 77.9 in 2007.

Other findings:

* Record high life expectancy was recorded for both males and females (75.3 years and 80.4 years, respectively). While the gap between male and female life expectancy has narrowed since the peak gap of 7.8 years in 1979, the 5.1 year difference in 2007 is the same as in 2006.

* For the first time, life expectancy for black males reached 70 years.

* The U.S. mortality rate fell for the eighth straight year to an all-time low of 760.3 deaths per 100,000 population in 2007 -- 2.1 percent lower than the 2006 rate of 776.5. The 2007 mortality rate is half of what it was 60 years ago (1532 per 100,000 in 1947.)

* The preliminary number of deaths in the United States in 2007 was 2,423,995, a 2,269 decrease from the 2006 total.

* Heart disease and cancer, the two leading causes of death, accounted for nearly half (48.5 percent) of all deaths in 2007.

* Between 2006 and 2007, mortality rates declined significantly for eight of the 15 leading causes of death. Declines were observed for influenza and pneumonia (8.4 percent), homicide (6.5 percent), accidents (5 percent), heart disease (4.7 percent), stroke (4.6 percent), diabetes (3.9 percent), hypertension (2.7 percent), and cancer (1.8 percent).

* The death rate for the fourth leading cause of death, chronic lower respiratory diseases, increased by 1.7 percent. Preliminary death rates also increased for Parkinson's disease, chronic liver disease and cirrhosis, and Alzheimer's, but these gains are not statistically significant.

* There were an estimated 11,061 deaths from HIV/AIDS in 2007, and mortality rates from the disease declined 10 percent from 2006, the biggest one-year decline since 1998. HIV remains the sixth leading cause of death among 25-44 year-olds.

* The preliminary infant mortality rate for 2007 was 6.77 infant deaths per 1,000 live births, a 1.2 percent increase from the 2006 rate of 6.69, though not considered statistically significant. Birth defects were the leading cause of infant death in 2007, followed by disorders related to preterm birth and low birthweight. Sudden infant death syndrome (SIDS) was the third leading cause of infant death in the United States.

The full report is available at www.cdc.gov/nchs.
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