By LOUISE RADNOFSKY
The Wall Street Journal
Originally posted on May 22, 2013
More than half of U.S. doctors have switched to electronic health records and are using them to manage patients' basic medical information and prescriptions, according to federal data set to be released Wednesday.
The Department of Health and Human Services says it has reached a tipping point as it seeks to steer medical providers away from paper records. Advocates for electronic health records say they have the potential to make medical care safer and more efficient. In 2015, the federal government will start penalizing providers that haven't begun using electronic health records in reimbursements they get for treating patients.
But some doctors have been cautious about changing long-standing practice, saying that typing into a computer while talking with patients requires more attention than taking notes by hand. Others are concerned that electronic systems don't allow for enough family history or fail to highlight the important parts of a patient's medical record. Some critics also cite privacy concerns.
The entire story is here.
Tuesday, June 4, 2013
Monday, June 3, 2013
Experts propose overhaul of ethics oversight of research
The Hastings Center
Press Release
Originally released January 2013
Hastings Center Special Report aims to 'provoke a national conversation'
The longstanding ethical framework for protecting human volunteers in medical research needs to be replaced because it is outdated and can impede efforts to improve health care quality, assert leaders in bioethics, medicine, and health policy in two companion articles in a Hastings Center Report special report, "Ethical Oversight of Learning Health Care Systems." One of the authors calling for a new approach is the main architect of the current ethical framework.
Seven commentaries in the publication, written by leaders with national responsibility for ethical oversight of medical research and efforts to improve health care quality, find areas of agreement and offer critiques.
In an accompanying editorial, co-guest editors Mildred Z. Solomon, President of The Hastings Center and Ann C. Bonham, Chief Scientific Officer at the American Association of Medical Colleges, wrote that by inviting these commentaries, they aimed to "provoke a national conversation." According to Solomon, "The challenge is to design oversight that adequately protects patients without impeding the kinds of data collection activities we need to improve health care quality, reduce disparities, and bring down our rate of medical errors." (See video of Dr. Solomon on the importance of this debate.)
For nearly four decades, protection of human participants in medical research has been based on the premise that there is a clear line between medical research and medical treatment. But, the two feature articles argue, that distinction has become blurred now that health care systems across the country are beginning to collect data from patients when they come in for treatment or follow-up. The Institute of Medicine has recommended that health care organizations do this kind of research, calling on them to become "learning health care systems."
In particular, the articles challenge the prevailing view that participating in medical research is inherently riskier and provides less benefit than receiving medical care. They point out that more than half of medical treatments lack evidence of effectiveness, putting patients at risk of harm. On the other hand, some kinds of clinical research are no riskier than clinical care and are potentially more beneficial; an example is comparative effectiveness research to find out which of two or more widely used interventions for a particular condition works best for which patients.
"Relying on this faulty research-practice distinction as the criterion that triggers ethical oversight has resulted in two major problems," the authors write. First, it has led to "delays, confusion, and frustrations in the regulatory environment" when institutional review boards, which are responsible for the ethical oversight of research with human subjects, have difficulty distinguishing between research and clinical practice. Second, it has "resulted in a morally questionable public policy in which many patients are either underprotected from clinical practice risks (when exposed to interventions of unproven effectiveness or to risks of medical error) or overprotected from learning activities that are of low risk . . . and that stand to contribute to improving health care safety, effectiveness, and value."
The authors call for a new ethical framework that "is commensurate with the risk and burden in both realms." Their second article outlines such a framework for determining the type and level of oversight needed for a learning health care system. The basic structure consists of seven obligations: 1) to respect the rights and dignity of patients; 2) to respect the clinical judgment of clinicians; 3) to provide optimal care to each patient; 4) to avoid imposing nonclinical risks and burdens on patients; 5) to reduce health inequalities among populations; 6) to conduct responsible activities that foster learning from clinical care and clinical information; and 7) to contribute to the common purpose of improving the quality and value of clinical care and the health system. The first six obligations would be the responsibility of researchers, clinicians, health care systems administrators, payers, and purchasers. The seventh obligation would be borne by patients.
Authors of the feature articles are Nancy E. Kass, deputy director for public health in the Johns Hopkins Berman Institute of Bioethics; Ruth R. Faden, director of the Johns Hopkins Berman Institute of Bioethics; Steven N. Goodman, associate dean for clinical and translational research at the Stanford University School of Medicine; Peter Pronovost, director of the Armstrong Institute for Patient Safety and Quality at Johns Hopkins; Sean Tunis, founder, president, and chief executive officer of the Center for Medical Technology Policy in Baltimore; and Tom L. Beauchamp, a professor of philosophy at Georgetown University and a senior research scholar at the Kennedy Institute of Ethics. Beauchamp was a chief architect of the Belmont Report, which established the existing research ethics framework in the United States.
The commentaries on the articles find common cause with the need to update clinical oversight for learning health care systems, but offer important critiques of the proposed framework. In particular, some hold that the research-treatment distinction is still useful and are concerned that the obligation for patients to participate in quality improvement efforts would exempt too many studies from voluntary informed consent and IRB protections.
Press Release
Originally released January 2013
Hastings Center Special Report aims to 'provoke a national conversation'
The longstanding ethical framework for protecting human volunteers in medical research needs to be replaced because it is outdated and can impede efforts to improve health care quality, assert leaders in bioethics, medicine, and health policy in two companion articles in a Hastings Center Report special report, "Ethical Oversight of Learning Health Care Systems." One of the authors calling for a new approach is the main architect of the current ethical framework.
Seven commentaries in the publication, written by leaders with national responsibility for ethical oversight of medical research and efforts to improve health care quality, find areas of agreement and offer critiques.
In an accompanying editorial, co-guest editors Mildred Z. Solomon, President of The Hastings Center and Ann C. Bonham, Chief Scientific Officer at the American Association of Medical Colleges, wrote that by inviting these commentaries, they aimed to "provoke a national conversation." According to Solomon, "The challenge is to design oversight that adequately protects patients without impeding the kinds of data collection activities we need to improve health care quality, reduce disparities, and bring down our rate of medical errors." (See video of Dr. Solomon on the importance of this debate.)
For nearly four decades, protection of human participants in medical research has been based on the premise that there is a clear line between medical research and medical treatment. But, the two feature articles argue, that distinction has become blurred now that health care systems across the country are beginning to collect data from patients when they come in for treatment or follow-up. The Institute of Medicine has recommended that health care organizations do this kind of research, calling on them to become "learning health care systems."
In particular, the articles challenge the prevailing view that participating in medical research is inherently riskier and provides less benefit than receiving medical care. They point out that more than half of medical treatments lack evidence of effectiveness, putting patients at risk of harm. On the other hand, some kinds of clinical research are no riskier than clinical care and are potentially more beneficial; an example is comparative effectiveness research to find out which of two or more widely used interventions for a particular condition works best for which patients.
"Relying on this faulty research-practice distinction as the criterion that triggers ethical oversight has resulted in two major problems," the authors write. First, it has led to "delays, confusion, and frustrations in the regulatory environment" when institutional review boards, which are responsible for the ethical oversight of research with human subjects, have difficulty distinguishing between research and clinical practice. Second, it has "resulted in a morally questionable public policy in which many patients are either underprotected from clinical practice risks (when exposed to interventions of unproven effectiveness or to risks of medical error) or overprotected from learning activities that are of low risk . . . and that stand to contribute to improving health care safety, effectiveness, and value."
The authors call for a new ethical framework that "is commensurate with the risk and burden in both realms." Their second article outlines such a framework for determining the type and level of oversight needed for a learning health care system. The basic structure consists of seven obligations: 1) to respect the rights and dignity of patients; 2) to respect the clinical judgment of clinicians; 3) to provide optimal care to each patient; 4) to avoid imposing nonclinical risks and burdens on patients; 5) to reduce health inequalities among populations; 6) to conduct responsible activities that foster learning from clinical care and clinical information; and 7) to contribute to the common purpose of improving the quality and value of clinical care and the health system. The first six obligations would be the responsibility of researchers, clinicians, health care systems administrators, payers, and purchasers. The seventh obligation would be borne by patients.
Authors of the feature articles are Nancy E. Kass, deputy director for public health in the Johns Hopkins Berman Institute of Bioethics; Ruth R. Faden, director of the Johns Hopkins Berman Institute of Bioethics; Steven N. Goodman, associate dean for clinical and translational research at the Stanford University School of Medicine; Peter Pronovost, director of the Armstrong Institute for Patient Safety and Quality at Johns Hopkins; Sean Tunis, founder, president, and chief executive officer of the Center for Medical Technology Policy in Baltimore; and Tom L. Beauchamp, a professor of philosophy at Georgetown University and a senior research scholar at the Kennedy Institute of Ethics. Beauchamp was a chief architect of the Belmont Report, which established the existing research ethics framework in the United States.
The commentaries on the articles find common cause with the need to update clinical oversight for learning health care systems, but offer important critiques of the proposed framework. In particular, some hold that the research-treatment distinction is still useful and are concerned that the obligation for patients to participate in quality improvement efforts would exempt too many studies from voluntary informed consent and IRB protections.
Ista Pharmaceuticals To Pay $33.5 Million To Settle Claims Company Paid Doctors To Push Drug
By Jonathan Stempel
Reuters
Originally published May 24, 2013
Ista Pharmaceuticals Inc pleaded guilty on Friday to charges it used kickbacks and improper marketing to boost sales of a drug meant to treat eye pain and agreed to pay $33.5 million to settle criminal and civil liability, the U.S. Department of Justice said.
The unit of eye care company Bausch & Lomb pleaded guilty to conspiracy to offer kickbacks to induce physicians to prescribe Xibrom, a drug meant to treat pain after cataract surgery, and conspiracy to promote that drug for unapproved uses, including after Lasik and glaucoma surgeries.
Ista agreed as part of a criminal settlement to a $16.63 million fine and an $1.85 million asset forfeiture. It also agreed to a $15 million civil settlement to resolve allegations that its marketing of Xibrom caused false claims to be submitted to government health care programs.
As part of the settlement, Ista will be barred from participating in Medicare and Medicaid, and Bausch & Lomb agreed to strengthen its compliance and ethics procedures.
The entire story is here.
Reuters
Originally published May 24, 2013
Ista Pharmaceuticals Inc pleaded guilty on Friday to charges it used kickbacks and improper marketing to boost sales of a drug meant to treat eye pain and agreed to pay $33.5 million to settle criminal and civil liability, the U.S. Department of Justice said.
The unit of eye care company Bausch & Lomb pleaded guilty to conspiracy to offer kickbacks to induce physicians to prescribe Xibrom, a drug meant to treat pain after cataract surgery, and conspiracy to promote that drug for unapproved uses, including after Lasik and glaucoma surgeries.
Ista agreed as part of a criminal settlement to a $16.63 million fine and an $1.85 million asset forfeiture. It also agreed to a $15 million civil settlement to resolve allegations that its marketing of Xibrom caused false claims to be submitted to government health care programs.
As part of the settlement, Ista will be barred from participating in Medicare and Medicaid, and Bausch & Lomb agreed to strengthen its compliance and ethics procedures.
The entire story is here.
Sunday, June 2, 2013
Relationship Between Sleep Duration And Suicidal Thoughts In People With Insomnia
Medical News Today
Originally published May 17, 2013
Results of a new study show that every one-hour increase in sleep duration was associated with a 72 percent decrease in the likelihood of moderate or high suicide risk, in comparison with low risk. Data were adjusted for age, gender, race/ethnicity, education and age of onset of sleep difficulties.
"We were surprised by the strength of the association between sleep duration and suicide risk," said primary author Linden Oliver, MA, clinical research coordinator for the University of Pennsylvania Behavioral Sleep Medicine Research Program in Philadelphia, Pa. "A 72 percent decrease in the likelihood of moderate or high suicide risk with a one-hour increase in sleep is interesting given the small sample size."
The research abstract was published recently in an online supplement of the journal SLEEP, and Oliver will present the findings Tuesday, June 4, in Baltimore, Md., at SLEEP 2013, the 27th annual meeting of the Associated Professional Sleep Societies LLC.
The entire story is here.
Originally published May 17, 2013
Results of a new study show that every one-hour increase in sleep duration was associated with a 72 percent decrease in the likelihood of moderate or high suicide risk, in comparison with low risk. Data were adjusted for age, gender, race/ethnicity, education and age of onset of sleep difficulties.
"We were surprised by the strength of the association between sleep duration and suicide risk," said primary author Linden Oliver, MA, clinical research coordinator for the University of Pennsylvania Behavioral Sleep Medicine Research Program in Philadelphia, Pa. "A 72 percent decrease in the likelihood of moderate or high suicide risk with a one-hour increase in sleep is interesting given the small sample size."
The research abstract was published recently in an online supplement of the journal SLEEP, and Oliver will present the findings Tuesday, June 4, in Baltimore, Md., at SLEEP 2013, the 27th annual meeting of the Associated Professional Sleep Societies LLC.
The entire story is here.
Schoolmates of suicide victims at higher risk
By Kathryn Doyle
Reuters
Originally published May 21, 2013
Teens who have a classmate die of suicide are more likely to consider taking, or attempt to take, their own lives, according to a new study.
The idea that suicide might be "contagious" has been around for centuries, senior author Dr. Ian Colman, who studies mental health at the University of Ottawa, told Reuters Health.
Past studies supported the idea, but none had looked at such a large body of students, he said.
"There were a lot of surprising things about this study, we were surprised that the effect lasted so long and just how strong it was," Colman said.
Colman and his colleagues used data from a long-running national survey of more than 8,000 Canadian kids aged 12 to 17 years old. Students were asked about suicides of schoolmates, friends and their own thoughts of suicide, and researchers checked in with the kids two years later.
By the age of 17, one in four kids had a schoolmate who had committed suicide, and one in five knew the deceased personally, according to results published in the Canadian Medical Association Journal.
The entire article is here.
Source Article: Association between exposure to suicide and suicidality outcomes in youth
CMAJ 2013. DOI:10.1503/cmaj.121377
Abstract
Background: Ecological studies support the hypothesis that suicide may be "contagious" (i.e., exposure to suicide may increase the risk of suicide and related outcomes). However, this association has not been adequately assessed in prospective studies. We sought to determine the association between exposure to suicide and suicidality outcomes in Canadian youth.
Methods: We used baseline information from the Canadian National Longitudinal Survey of Children and Youth between 1998/99 and 2006/07 with follow-up assessments 2 years later. We included all respondents aged 12–17 years in cycles 3–7 with reported measures of exposure to suicide.
Results: We included 8766 youth aged 12–13 years, 7802 aged 14–15 years and 5496 aged 16–17 years. Exposure to a schoolmate's suicide was associated with ideation at baseline among respondents aged 12–13 years (odds ratio [OR] 5.06, 95% confidence interval [CI] 3.04–8.40), 14–15 years (OR 2.93, 95% CI 2.02–4.24) and 16–17 years (OR 2.23, 95% CI 1.43–3.48). Such exposure was associated with attempts among respondents aged 12–13 years (OR 4.57, 95% CI 2.39–8.71), 14–15 years (OR 3.99, 95% CI 2.46–6.45) and 16–17 years (OR 3.22, 95% CI 1.62–6.41). Personally knowing someone who died by suicide was associated with suicidality outcomes for all age groups. We also assessed 2-year outcomes among respondents aged 12–15 years: a schoolmate's suicide predicted suicide attempts among participants aged 12–13 years (OR 3.07, 95% CI 1.05–8.96) and 14–15 years (OR 2.72, 95% CI 1.47–5.04). Among those who reported a schoolmate's suicide, personally knowing the decedent did not alter the risk of suicidality.
Interpretation: We found that exposure to suicide predicts suicide ideation and attempts. Our results support school-wide interventions over current targeted interventions, particularly over strategies that target interventions toward children closest to the decedent.
The source article is here.
Reuters
Originally published May 21, 2013
Teens who have a classmate die of suicide are more likely to consider taking, or attempt to take, their own lives, according to a new study.
The idea that suicide might be "contagious" has been around for centuries, senior author Dr. Ian Colman, who studies mental health at the University of Ottawa, told Reuters Health.
Past studies supported the idea, but none had looked at such a large body of students, he said.
"There were a lot of surprising things about this study, we were surprised that the effect lasted so long and just how strong it was," Colman said.
Colman and his colleagues used data from a long-running national survey of more than 8,000 Canadian kids aged 12 to 17 years old. Students were asked about suicides of schoolmates, friends and their own thoughts of suicide, and researchers checked in with the kids two years later.
By the age of 17, one in four kids had a schoolmate who had committed suicide, and one in five knew the deceased personally, according to results published in the Canadian Medical Association Journal.
The entire article is here.
Source Article: Association between exposure to suicide and suicidality outcomes in youth
CMAJ 2013. DOI:10.1503/cmaj.121377
Abstract
Background: Ecological studies support the hypothesis that suicide may be "contagious" (i.e., exposure to suicide may increase the risk of suicide and related outcomes). However, this association has not been adequately assessed in prospective studies. We sought to determine the association between exposure to suicide and suicidality outcomes in Canadian youth.
Methods: We used baseline information from the Canadian National Longitudinal Survey of Children and Youth between 1998/99 and 2006/07 with follow-up assessments 2 years later. We included all respondents aged 12–17 years in cycles 3–7 with reported measures of exposure to suicide.
Results: We included 8766 youth aged 12–13 years, 7802 aged 14–15 years and 5496 aged 16–17 years. Exposure to a schoolmate's suicide was associated with ideation at baseline among respondents aged 12–13 years (odds ratio [OR] 5.06, 95% confidence interval [CI] 3.04–8.40), 14–15 years (OR 2.93, 95% CI 2.02–4.24) and 16–17 years (OR 2.23, 95% CI 1.43–3.48). Such exposure was associated with attempts among respondents aged 12–13 years (OR 4.57, 95% CI 2.39–8.71), 14–15 years (OR 3.99, 95% CI 2.46–6.45) and 16–17 years (OR 3.22, 95% CI 1.62–6.41). Personally knowing someone who died by suicide was associated with suicidality outcomes for all age groups. We also assessed 2-year outcomes among respondents aged 12–15 years: a schoolmate's suicide predicted suicide attempts among participants aged 12–13 years (OR 3.07, 95% CI 1.05–8.96) and 14–15 years (OR 2.72, 95% CI 1.47–5.04). Among those who reported a schoolmate's suicide, personally knowing the decedent did not alter the risk of suicidality.
Interpretation: We found that exposure to suicide predicts suicide ideation and attempts. Our results support school-wide interventions over current targeted interventions, particularly over strategies that target interventions toward children closest to the decedent.
The source article is here.
Saturday, June 1, 2013
Anti-Gay Bullying Tied to Teen Depression, Suicide
By Randy Dotinga
HealthDay Reporter
Originally published May 16, 2013
Students targeted because they're believed to be gay -- as many as one in seven young teens -- are much more likely than others to be suicidal and depressed, a new survey finds.
More than 10 percent of eighth-grade boys and girls reported that they're victimized because of perceived sexual orientation, according to a large survey of students in Washington state.
"It has a profound impact on their quality of life and the way they think of themselves," said Donald Patrick, a professor of health services at the University of Washington in Seattle. "Those in eighth grade are in a particularly vulnerable position."
These children "feel alone in life, that they don't feel as good as other people and their self-esteem is highly affected," Patrick said.
The survey results, published online May 16 in the American Journal of Public Health, don't offer insight into whether bullying contributes to depression and suicidal thoughts in its victims. It's possible that kids with existing mental illnesses may be more likely to be bullied and perceived as gay.
The entire story is here.
HealthDay Reporter
Originally published May 16, 2013
Students targeted because they're believed to be gay -- as many as one in seven young teens -- are much more likely than others to be suicidal and depressed, a new survey finds.
More than 10 percent of eighth-grade boys and girls reported that they're victimized because of perceived sexual orientation, according to a large survey of students in Washington state.
"It has a profound impact on their quality of life and the way they think of themselves," said Donald Patrick, a professor of health services at the University of Washington in Seattle. "Those in eighth grade are in a particularly vulnerable position."
These children "feel alone in life, that they don't feel as good as other people and their self-esteem is highly affected," Patrick said.
The survey results, published online May 16 in the American Journal of Public Health, don't offer insight into whether bullying contributes to depression and suicidal thoughts in its victims. It's possible that kids with existing mental illnesses may be more likely to be bullied and perceived as gay.
The entire story is here.
Friday, May 31, 2013
Not robots: children's perspectives on authenticity, moral agency and stimulant drug treatments
By Ilina Singh
J Med Ethics 2013;39:359-366 doi:10.1136/medethics-2011-100224
Abstract
In this article, I examine children's reported experiences with stimulant drug treatments for attention deficit hyperactivity disorder in light of bioethical arguments about the potential threats of psychotropic drugs to authenticity and moral agency. Drawing on a study that involved over 150 families in the USA and the UK, I show that children are able to report threats to authenticity, but that the majority of children are not concerned with such threats. On balance, children report that stimulants improve their capacity for moral agency, and they associate this capacity with an ability to meet normative expectations. I argue that although under certain conditions stimulant drug treatment may increase the risk of a threat to authenticity, there are ways to minimise this risk and to maximise the benefits of stimulant drug treatment. Medical professionals in particular should help children to flourish with stimulant drug treatments, in good and in bad conditions.
The entire article is here.
J Med Ethics 2013;39:359-366 doi:10.1136/medethics-2011-100224
Abstract
In this article, I examine children's reported experiences with stimulant drug treatments for attention deficit hyperactivity disorder in light of bioethical arguments about the potential threats of psychotropic drugs to authenticity and moral agency. Drawing on a study that involved over 150 families in the USA and the UK, I show that children are able to report threats to authenticity, but that the majority of children are not concerned with such threats. On balance, children report that stimulants improve their capacity for moral agency, and they associate this capacity with an ability to meet normative expectations. I argue that although under certain conditions stimulant drug treatment may increase the risk of a threat to authenticity, there are ways to minimise this risk and to maximise the benefits of stimulant drug treatment. Medical professionals in particular should help children to flourish with stimulant drug treatments, in good and in bad conditions.
The entire article is here.
1 in 5 U.S. Kids Has a Mental Health Disorder: CDC
By Brenda Goodman
HealthDay Reporter
Originally published May 16, 2013
As many as one in five American children under the age of 17 has a diagnosable mental disorder in a given year, according to a new federal report.
Released Thursday, the report represents the government's first comprehensive look at mental disorders in children. It focuses on diagnoses in six areas: attention-deficit/hyperactivity disorder (ADHD), behavioral or conduct disorders, mood and anxiety disorders, autism spectrum disorders, substance abuse, and Tourette syndrome.
The most common mental disorder among children aged 3 through 17 is ADHD. Nearly 7 percent -- about one in 15 children -- in that age group have a current diagnosis, according to the report from the U.S. Centers for Disease Control and Prevention.
The entire story is here.
HealthDay Reporter
Originally published May 16, 2013
As many as one in five American children under the age of 17 has a diagnosable mental disorder in a given year, according to a new federal report.
Released Thursday, the report represents the government's first comprehensive look at mental disorders in children. It focuses on diagnoses in six areas: attention-deficit/hyperactivity disorder (ADHD), behavioral or conduct disorders, mood and anxiety disorders, autism spectrum disorders, substance abuse, and Tourette syndrome.
The most common mental disorder among children aged 3 through 17 is ADHD. Nearly 7 percent -- about one in 15 children -- in that age group have a current diagnosis, according to the report from the U.S. Centers for Disease Control and Prevention.
The entire story is here.
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