Thoracic Surgery News (Archived)

The issue of scientific reproducibility has come to the fore in the past several years, driven by noteworthy failures to replicate critical findings in several much-publicized reports coupled to a series of scandals calling into question the role of journals and granting agencies in maintaining quality and oversight.

In a special Nature online collection, the journal assembled articles and perspectives from 2011 to the present dealing with this issue of research reproducibility in science and medicine. These articles were supplemented with current editorial comment.

Seeing these broad spectrum concerns pulled together in one place makes it difficult not to be pessimistic about the current state of research investigations across the board. The saving grace, however, is that these same reports show that a lot of people realize that there is a problem – people who are trying to make changes and who are in a position to be effective.

According to the reports presented in the collection, the problems in research accountability and reproducibility have grown to an alarming extent. In one estimate, irreproducibility ends up costing biomedical research some $28 billion wasted dollars per year (Nature. 2015 Jun 9. doi: 10.1038/nature.2015.17711).

A litany of concerns

In 2012, scientists at AMGEN (Thousand Oaks, Calif.) reported that, even cooperating closely with the original investigators, they were able to reproduce only 6 of 53 studies considered to be benchmarks of cancer research (Nature. 2016 Feb 4. doi: 10.1038/nature.2016.19269).

Scientists at Bayer HealthCare reported in Nature Reviews Drug Discovery that they could successfully reproduce results in only a quarter of 67 so-called seminal studies (2011 Sep. doi: 10.1038/nrd3439-c1).

According to a 2013 report in The Economist, Dr. John Ioannidis, an expert in the field of scientific reproducibility, argued that in his field, “epidemiology, you might expect one in ten hypotheses to be true. In exploratory disciplines like genomics, which rely on combing through vast troves of data about genes and proteins for interesting relationships, you might expect just one in a thousand to prove correct.”

This increasing litany of irreproducibility has raised alarm in the scientific community and has led to a search for answers, as so many preclinical studies form the precursor data for eventual human trials.

Despite the concerns raised, human clinical trials seem to be less at risk for irreproducibility, according to an editorial by Dr. Francis S. Collins, director, and Dr. Lawrence A. Tabak, principal deputy director of the U.S. National Institutes of Health, “because they are already governed by various regulations that stipulate rigorous design and independent oversight – including randomization, blinding, power estimates, pre-registration of outcome measures in standardized, public databases such as ClinicalTrials.gov and oversight by institutional review boards and data safety monitoring boards. Furthermore, the clinical trials community has taken important steps toward adopting standard reporting elements,” (Nature. 2014 Jan. doi: 10.1038/505612a).

The paucity of P

Today, the P-value, .05 or less, is all too often considered the sine qua non of scientific proof. “Most statisticians consider this appalling, as the P value was never intended to be used as a strong indicator of certainty as it too often is today. Most scientists would look at [a] P value of .01 and say that there was just a 1% chance of [the] result being a false alarm. But they would be wrong.” The 2014 report goes on to state how, according to one widely used calculation by authentic statisticians, a P value of .01 corresponds to a false-alarm probability of at least 11%, depending on the underlying probability that there is a true effect; a P value of .05 raises that chance of a false alarm to at least 29% (Nature. 2014 Feb. doi: 10.1038/506150a).

Beyond this assessment problem, P values may allow for considerable researcher bias, conscious and unconscious, even to the extent of encouraging “P-hacking”: one of the few statistical terms to ever make it into the Urban Dictionary. “P-hacking is trying multiple things until you get the desired result” – even unconsciously, according to one researcher quoted.

In addition, “unless statistical power is very high (and much higher than in most experiments), the P value should be interpreted tentatively at best” (Nat Methods. 2015 Feb 26. doi: 10.1038/nmeth.3288).

So bad is the problem that “misuse of the P value – a common test for judging the strength of scientific evidence – is contributing to the number of research findings that cannot be reproduced,” the American Statistical Association warns in a statement released in March, adding that the P value cannot be used to determine whether a hypothesis is true or even whether results are important (Nature. 2016 Mar 7. doi: 10.1038/nature.2016.19503).

And none of this even remotely addresses those instances where researchers report findings that “trend towards significance” when they can’t even meet the magical P threshold.

A muddling of mice (and more)

Fundamental to biological research is the vast array of preliminary animal studies that must be performed before clinical testing can begin.

Animal-based research has been under intense scrutiny due to a variety of perceived flaws and omissions that have been found to be all too common. For example, in a report in PLoS Biology, Dr. Ulrich Dirnagl of the Charité Medical University in Berlin reviewed 100 reports published between 2000 and 2013, which included 522 experiments using rodents to test cancer and stroke treatments. Around two-thirds of the experiments did not report whether any animals had been dropped from the final analysis, and of the 30% that did report rodents dropped from analysis, only 14 explained why (2016 Jan 4. doi: 10.1371/journal.pbio.1002331). Similarly, Dr. John Ioannidis and his colleagues assessed a random sample of 268 biomedical papers listed in PubMed published between 2000 and 2014 and found that only one contained sufficient details to replicate the work (Nature. 2016 Jan 5. doi: 10.1038/nature.2015.19101).

A multitude of genetic and environmental factors have also been found influential in animal research. For example, the gut microbiome (which has been found to influence many aspects of mouse health and metabolism) varies widely in the same species of mice fed on different diets or obtained from different vendors. And there can be differences in physiology and behavior based on circadian rhythms, and even variations in cage design (Nature. 2016 Feb 16. doi: 10.1038/530254a).

But things are looking brighter. By the beginning of 2016, more than 600 journals had signed up for the voluntary ARRIVE (Animals in Research: Reporting of In Vivo Experiments) guidelines designed to improve the reporting of animal experiments. The guidelines include a checklist of elements to be included in any reporting of animal research, including animal strain, sex, and adverse events (Nature. 2016 Feb 1. doi: 10.1038/nature.2016.19274).

Problems have also been reported in the use of cell lines and antibodies in biomedical research. For example, a report in Nature indicated that too many biomedical researchers are lax in checking for impostor cell lines when they perform their research (Nature. 2015 Oct 12. doi: 10.1038/nature.2015.18544). And recent studies have shown that improper or misused antibodies are a significant source of false findings and irreproducibility in the modern literature (Nature. 2015 May 19. doi: 10.1038/521274a).

Reviewer, view thyself

The editorial in The Economist also discussed some of the failures of the peer-reviewed scientific literature, usually considered the final gateway of quality control, to provide appropriate review and correction of research errors. The editorial cites a damning test of lower-tier research publications by Dr. John Bohannon, a biologist at Harvard, who submitted a pseudonymous paper on the effects of a chemical derived from lichen cells to 304 journals describing themselves as using peer review. The paper was concocted wholesale with manifold and obvious errors in study design, analysis, and interpretation of results, according to Dr. Bohannon. This fictitious paper from a fictitious researcher based at a fictitious university was accepted for publication by an alarming 147 of the journals.

The problem is not new. In 1998, Dr. Fiona Godlee, editor of the British Medical Journal, sent an article with eight deliberate mistakes in study design, analysis, and interpretation to more than 200 of the journal’s regular reviewers. None of the reviewers found all the mistakes, and on average, they spotted fewer than two. And another study by the BMJ showed that experience was an issue, not in improving quality of reviewers, but quite the opposite. Over a 14-year period assessed, 1,500 referees, as rated by editors at leading journals, showed a slow but steady drop in their scores.

Such studies prompted a profound reassessment by the journals, in part pushed by some major granting agencies, including the National Institutes of Health.

Not taking grants for granted

The National Institutes for Health are advancing efforts to expand scientific rigor and reproducibility in their grants projects.

“As part of an increasing drive to boost the reliability of research, the NIH will require applicants to explain the scientific premise behind their proposals and defend the quality of their experimental designs. They must also account for biological variables (for example, by including both male and female mice in planned studies) and describe how they will authenticate experimental materials such as cell lines and antibodies.”

Whether current efforts by scientists, societies, granting organizations, and journals can lead to authentic reform and a vast and relatively quick improvement in reproducibility of scientific results is still an open question. In discussing a 2015 report on the subject by the biomedical research community in the United Kingdom, neurophysiologist Dr. Dorothy Bishop had this to say: “I feel quite upbeat about it. ... Now that we’re aware of it, we have all sorts of ideas about how to deal with it. These are doable things. I feel that the mood is one of making science a much better thing. It might lead to slightly slower science. That could be better” (Nature. 2015 Oct 29. doi: 10.1038/nature.2015.18684).

[email protected]

The issue of scientific reproducibility has come to the fore in the past several years, driven by noteworthy failures to replicate critical findings in several much-publicized reports coupled to a series of scandals calling into question the role of journals and granting agencies in maintaining quality and oversight.

In a special Nature online collection, the journal assembled articles and perspectives from 2011 to the present dealing with this issue of research reproducibility in science and medicine. These articles were supplemented with current editorial comment.

Seeing these broad spectrum concerns pulled together in one place makes it difficult not to be pessimistic about the current state of research investigations across the board. The saving grace, however, is that these same reports show that a lot of people realize that there is a problem – people who are trying to make changes and who are in a position to be effective.

According to the reports presented in the collection, the problems in research accountability and reproducibility have grown to an alarming extent. In one estimate, irreproducibility ends up costing biomedical research some $28 billion wasted dollars per year (Nature. 2015 Jun 9. doi: 10.1038/nature.2015.17711).

A litany of concerns

In 2012, scientists at AMGEN (Thousand Oaks, Calif.) reported that, even cooperating closely with the original investigators, they were able to reproduce only 6 of 53 studies considered to be benchmarks of cancer research (Nature. 2016 Feb 4. doi: 10.1038/nature.2016.19269).

Scientists at Bayer HealthCare reported in Nature Reviews Drug Discovery that they could successfully reproduce results in only a quarter of 67 so-called seminal studies (2011 Sep. doi: 10.1038/nrd3439-c1).

According to a 2013 report in The Economist, Dr. John Ioannidis, an expert in the field of scientific reproducibility, argued that in his field, “epidemiology, you might expect one in ten hypotheses to be true. In exploratory disciplines like genomics, which rely on combing through vast troves of data about genes and proteins for interesting relationships, you might expect just one in a thousand to prove correct.”

This increasing litany of irreproducibility has raised alarm in the scientific community and has led to a search for answers, as so many preclinical studies form the precursor data for eventual human trials.

Despite the concerns raised, human clinical trials seem to be less at risk for irreproducibility, according to an editorial by Dr. Francis S. Collins, director, and Dr. Lawrence A. Tabak, principal deputy director of the U.S. National Institutes of Health, “because they are already governed by various regulations that stipulate rigorous design and independent oversight – including randomization, blinding, power estimates, pre-registration of outcome measures in standardized, public databases such as ClinicalTrials.gov and oversight by institutional review boards and data safety monitoring boards. Furthermore, the clinical trials community has taken important steps toward adopting standard reporting elements,” (Nature. 2014 Jan. doi: 10.1038/505612a).

The paucity of P

Today, the P-value, .05 or less, is all too often considered the sine qua non of scientific proof. “Most statisticians consider this appalling, as the P value was never intended to be used as a strong indicator of certainty as it too often is today. Most scientists would look at [a] P value of .01 and say that there was just a 1% chance of [the] result being a false alarm. But they would be wrong.” The 2014 report goes on to state how, according to one widely used calculation by authentic statisticians, a P value of .01 corresponds to a false-alarm probability of at least 11%, depending on the underlying probability that there is a true effect; a P value of .05 raises that chance of a false alarm to at least 29% (Nature. 2014 Feb. doi: 10.1038/506150a).

Beyond this assessment problem, P values may allow for considerable researcher bias, conscious and unconscious, even to the extent of encouraging “P-hacking”: one of the few statistical terms to ever make it into the Urban Dictionary. “P-hacking is trying multiple things until you get the desired result” – even unconsciously, according to one researcher quoted.

In addition, “unless statistical power is very high (and much higher than in most experiments), the P value should be interpreted tentatively at best” (Nat Methods. 2015 Feb 26. doi: 10.1038/nmeth.3288).

So bad is the problem that “misuse of the P value – a common test for judging the strength of scientific evidence – is contributing to the number of research findings that cannot be reproduced,” the American Statistical Association warns in a statement released in March, adding that the P value cannot be used to determine whether a hypothesis is true or even whether results are important (Nature. 2016 Mar 7. doi: 10.1038/nature.2016.19503).

And none of this even remotely addresses those instances where researchers report findings that “trend towards significance” when they can’t even meet the magical P threshold.

A muddling of mice (and more)

Fundamental to biological research is the vast array of preliminary animal studies that must be performed before clinical testing can begin.

Animal-based research has been under intense scrutiny due to a variety of perceived flaws and omissions that have been found to be all too common. For example, in a report in PLoS Biology, Dr. Ulrich Dirnagl of the Charité Medical University in Berlin reviewed 100 reports published between 2000 and 2013, which included 522 experiments using rodents to test cancer and stroke treatments. Around two-thirds of the experiments did not report whether any animals had been dropped from the final analysis, and of the 30% that did report rodents dropped from analysis, only 14 explained why (2016 Jan 4. doi: 10.1371/journal.pbio.1002331). Similarly, Dr. John Ioannidis and his colleagues assessed a random sample of 268 biomedical papers listed in PubMed published between 2000 and 2014 and found that only one contained sufficient details to replicate the work (Nature. 2016 Jan 5. doi: 10.1038/nature.2015.19101).

A multitude of genetic and environmental factors have also been found influential in animal research. For example, the gut microbiome (which has been found to influence many aspects of mouse health and metabolism) varies widely in the same species of mice fed on different diets or obtained from different vendors. And there can be differences in physiology and behavior based on circadian rhythms, and even variations in cage design (Nature. 2016 Feb 16. doi: 10.1038/530254a).

But things are looking brighter. By the beginning of 2016, more than 600 journals had signed up for the voluntary ARRIVE (Animals in Research: Reporting of In Vivo Experiments) guidelines designed to improve the reporting of animal experiments. The guidelines include a checklist of elements to be included in any reporting of animal research, including animal strain, sex, and adverse events (Nature. 2016 Feb 1. doi: 10.1038/nature.2016.19274).

Problems have also been reported in the use of cell lines and antibodies in biomedical research. For example, a report in Nature indicated that too many biomedical researchers are lax in checking for impostor cell lines when they perform their research (Nature. 2015 Oct 12. doi: 10.1038/nature.2015.18544). And recent studies have shown that improper or misused antibodies are a significant source of false findings and irreproducibility in the modern literature (Nature. 2015 May 19. doi: 10.1038/521274a).

Reviewer, view thyself

The editorial in The Economist also discussed some of the failures of the peer-reviewed scientific literature, usually considered the final gateway of quality control, to provide appropriate review and correction of research errors. The editorial cites a damning test of lower-tier research publications by Dr. John Bohannon, a biologist at Harvard, who submitted a pseudonymous paper on the effects of a chemical derived from lichen cells to 304 journals describing themselves as using peer review. The paper was concocted wholesale with manifold and obvious errors in study design, analysis, and interpretation of results, according to Dr. Bohannon. This fictitious paper from a fictitious researcher based at a fictitious university was accepted for publication by an alarming 147 of the journals.

The problem is not new. In 1998, Dr. Fiona Godlee, editor of the British Medical Journal, sent an article with eight deliberate mistakes in study design, analysis, and interpretation to more than 200 of the journal’s regular reviewers. None of the reviewers found all the mistakes, and on average, they spotted fewer than two. And another study by the BMJ showed that experience was an issue, not in improving quality of reviewers, but quite the opposite. Over a 14-year period assessed, 1,500 referees, as rated by editors at leading journals, showed a slow but steady drop in their scores.

Such studies prompted a profound reassessment by the journals, in part pushed by some major granting agencies, including the National Institutes of Health.

Not taking grants for granted

The National Institutes for Health are advancing efforts to expand scientific rigor and reproducibility in their grants projects.

“As part of an increasing drive to boost the reliability of research, the NIH will require applicants to explain the scientific premise behind their proposals and defend the quality of their experimental designs. They must also account for biological variables (for example, by including both male and female mice in planned studies) and describe how they will authenticate experimental materials such as cell lines and antibodies.”

Whether current efforts by scientists, societies, granting organizations, and journals can lead to authentic reform and a vast and relatively quick improvement in reproducibility of scientific results is still an open question. In discussing a 2015 report on the subject by the biomedical research community in the United Kingdom, neurophysiologist Dr. Dorothy Bishop had this to say: “I feel quite upbeat about it. ... Now that we’re aware of it, we have all sorts of ideas about how to deal with it. These are doable things. I feel that the mood is one of making science a much better thing. It might lead to slightly slower science. That could be better” (Nature. 2015 Oct 29. doi: 10.1038/nature.2015.18684).

[email protected]

The issue of scientific reproducibility has come to the fore in the past several years, driven by noteworthy failures to replicate critical findings in several much-publicized reports coupled to a series of scandals calling into question the role of journals and granting agencies in maintaining quality and oversight.

In a special Nature online collection, the journal assembled articles and perspectives from 2011 to the present dealing with this issue of research reproducibility in science and medicine. These articles were supplemented with current editorial comment.

Seeing these broad spectrum concerns pulled together in one place makes it difficult not to be pessimistic about the current state of research investigations across the board. The saving grace, however, is that these same reports show that a lot of people realize that there is a problem – people who are trying to make changes and who are in a position to be effective.

According to the reports presented in the collection, the problems in research accountability and reproducibility have grown to an alarming extent. In one estimate, irreproducibility ends up costing biomedical research some $28 billion wasted dollars per year (Nature. 2015 Jun 9. doi: 10.1038/nature.2015.17711).

A litany of concerns

In 2012, scientists at AMGEN (Thousand Oaks, Calif.) reported that, even cooperating closely with the original investigators, they were able to reproduce only 6 of 53 studies considered to be benchmarks of cancer research (Nature. 2016 Feb 4. doi: 10.1038/nature.2016.19269).

Scientists at Bayer HealthCare reported in Nature Reviews Drug Discovery that they could successfully reproduce results in only a quarter of 67 so-called seminal studies (2011 Sep. doi: 10.1038/nrd3439-c1).

According to a 2013 report in The Economist, Dr. John Ioannidis, an expert in the field of scientific reproducibility, argued that in his field, “epidemiology, you might expect one in ten hypotheses to be true. In exploratory disciplines like genomics, which rely on combing through vast troves of data about genes and proteins for interesting relationships, you might expect just one in a thousand to prove correct.”

This increasing litany of irreproducibility has raised alarm in the scientific community and has led to a search for answers, as so many preclinical studies form the precursor data for eventual human trials.

Despite the concerns raised, human clinical trials seem to be less at risk for irreproducibility, according to an editorial by Dr. Francis S. Collins, director, and Dr. Lawrence A. Tabak, principal deputy director of the U.S. National Institutes of Health, “because they are already governed by various regulations that stipulate rigorous design and independent oversight – including randomization, blinding, power estimates, pre-registration of outcome measures in standardized, public databases such as ClinicalTrials.gov and oversight by institutional review boards and data safety monitoring boards. Furthermore, the clinical trials community has taken important steps toward adopting standard reporting elements,” (Nature. 2014 Jan. doi: 10.1038/505612a).

The paucity of P

Today, the P-value, .05 or less, is all too often considered the sine qua non of scientific proof. “Most statisticians consider this appalling, as the P value was never intended to be used as a strong indicator of certainty as it too often is today. Most scientists would look at [a] P value of .01 and say that there was just a 1% chance of [the] result being a false alarm. But they would be wrong.” The 2014 report goes on to state how, according to one widely used calculation by authentic statisticians, a P value of .01 corresponds to a false-alarm probability of at least 11%, depending on the underlying probability that there is a true effect; a P value of .05 raises that chance of a false alarm to at least 29% (Nature. 2014 Feb. doi: 10.1038/506150a).

Beyond this assessment problem, P values may allow for considerable researcher bias, conscious and unconscious, even to the extent of encouraging “P-hacking”: one of the few statistical terms to ever make it into the Urban Dictionary. “P-hacking is trying multiple things until you get the desired result” – even unconsciously, according to one researcher quoted.

In addition, “unless statistical power is very high (and much higher than in most experiments), the P value should be interpreted tentatively at best” (Nat Methods. 2015 Feb 26. doi: 10.1038/nmeth.3288).

So bad is the problem that “misuse of the P value – a common test for judging the strength of scientific evidence – is contributing to the number of research findings that cannot be reproduced,” the American Statistical Association warns in a statement released in March, adding that the P value cannot be used to determine whether a hypothesis is true or even whether results are important (Nature. 2016 Mar 7. doi: 10.1038/nature.2016.19503).

And none of this even remotely addresses those instances where researchers report findings that “trend towards significance” when they can’t even meet the magical P threshold.

A muddling of mice (and more)

Fundamental to biological research is the vast array of preliminary animal studies that must be performed before clinical testing can begin.

Animal-based research has been under intense scrutiny due to a variety of perceived flaws and omissions that have been found to be all too common. For example, in a report in PLoS Biology, Dr. Ulrich Dirnagl of the Charité Medical University in Berlin reviewed 100 reports published between 2000 and 2013, which included 522 experiments using rodents to test cancer and stroke treatments. Around two-thirds of the experiments did not report whether any animals had been dropped from the final analysis, and of the 30% that did report rodents dropped from analysis, only 14 explained why (2016 Jan 4. doi: 10.1371/journal.pbio.1002331). Similarly, Dr. John Ioannidis and his colleagues assessed a random sample of 268 biomedical papers listed in PubMed published between 2000 and 2014 and found that only one contained sufficient details to replicate the work (Nature. 2016 Jan 5. doi: 10.1038/nature.2015.19101).

A multitude of genetic and environmental factors have also been found influential in animal research. For example, the gut microbiome (which has been found to influence many aspects of mouse health and metabolism) varies widely in the same species of mice fed on different diets or obtained from different vendors. And there can be differences in physiology and behavior based on circadian rhythms, and even variations in cage design (Nature. 2016 Feb 16. doi: 10.1038/530254a).

But things are looking brighter. By the beginning of 2016, more than 600 journals had signed up for the voluntary ARRIVE (Animals in Research: Reporting of In Vivo Experiments) guidelines designed to improve the reporting of animal experiments. The guidelines include a checklist of elements to be included in any reporting of animal research, including animal strain, sex, and adverse events (Nature. 2016 Feb 1. doi: 10.1038/nature.2016.19274).

Problems have also been reported in the use of cell lines and antibodies in biomedical research. For example, a report in Nature indicated that too many biomedical researchers are lax in checking for impostor cell lines when they perform their research (Nature. 2015 Oct 12. doi: 10.1038/nature.2015.18544). And recent studies have shown that improper or misused antibodies are a significant source of false findings and irreproducibility in the modern literature (Nature. 2015 May 19. doi: 10.1038/521274a).

Reviewer, view thyself

The editorial in The Economist also discussed some of the failures of the peer-reviewed scientific literature, usually considered the final gateway of quality control, to provide appropriate review and correction of research errors. The editorial cites a damning test of lower-tier research publications by Dr. John Bohannon, a biologist at Harvard, who submitted a pseudonymous paper on the effects of a chemical derived from lichen cells to 304 journals describing themselves as using peer review. The paper was concocted wholesale with manifold and obvious errors in study design, analysis, and interpretation of results, according to Dr. Bohannon. This fictitious paper from a fictitious researcher based at a fictitious university was accepted for publication by an alarming 147 of the journals.

The problem is not new. In 1998, Dr. Fiona Godlee, editor of the British Medical Journal, sent an article with eight deliberate mistakes in study design, analysis, and interpretation to more than 200 of the journal’s regular reviewers. None of the reviewers found all the mistakes, and on average, they spotted fewer than two. And another study by the BMJ showed that experience was an issue, not in improving quality of reviewers, but quite the opposite. Over a 14-year period assessed, 1,500 referees, as rated by editors at leading journals, showed a slow but steady drop in their scores.

Such studies prompted a profound reassessment by the journals, in part pushed by some major granting agencies, including the National Institutes of Health.

Not taking grants for granted

The National Institutes for Health are advancing efforts to expand scientific rigor and reproducibility in their grants projects.

“As part of an increasing drive to boost the reliability of research, the NIH will require applicants to explain the scientific premise behind their proposals and defend the quality of their experimental designs. They must also account for biological variables (for example, by including both male and female mice in planned studies) and describe how they will authenticate experimental materials such as cell lines and antibodies.”

Whether current efforts by scientists, societies, granting organizations, and journals can lead to authentic reform and a vast and relatively quick improvement in reproducibility of scientific results is still an open question. In discussing a 2015 report on the subject by the biomedical research community in the United Kingdom, neurophysiologist Dr. Dorothy Bishop had this to say: “I feel quite upbeat about it. ... Now that we’re aware of it, we have all sorts of ideas about how to deal with it. These are doable things. I feel that the mood is one of making science a much better thing. It might lead to slightly slower science. That could be better” (Nature. 2015 Oct 29. doi: 10.1038/nature.2015.18684).

[email protected]

The Food and Drug Administration has proposed a ban on most powdered gloves used during surgery and for patient examination, and on absorbable powder used for lubricating surgeons’ gloves.

Aerosolized glove powder on natural rubber latex gloves can cause respiratory allergic reactions, and while powdered synthetic gloves don’t present the risk of allergic reactions, all powdered gloves have been associated with numerous potentially serious adverse events, including severe airway inflammation, wound inflammation, and postsurgical adhesions, according to an FDA statement.

The proposed ban would not apply to powdered radiographic protection gloves; the agency is not aware of any such gloves that are currently on the market. The ban also would not affect non-powdered gloves.

The decision to move forward with the proposed ban was based on a determination that the affected products “are dangerous and present an unreasonable and substantial risk,” according to the statement.

In making this determination, the FDA considered the available evidence, including a literature review and the 285 comments received on a February 2011 Federal Register Notice.

That notice announced the establishment of a public docket to receive comments related to powdered gloves and followed the FDA’s receipt of two citizen petitions requesting a ban on such gloves because of the adverse health effects associated with use of the gloves. The comments overwhelmingly supported a warning or ban.

The FDA determined that the risks associated with powdered gloves cannot be corrected through new or updated labeling, and thus moved forward with the proposed ban.

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health said in the statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

In fact, should this ban be put into place, it would be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit. The benefits cited for powdered gloves were almost entirely related to greater ease of putting the gloves on and taking them off, Eric Pahon of the FDA said in an interview.

A ban on the gloves was not proposed sooner in part because when concerns were first raised about the risks associated with powdered gloves, a ban would have created a shortage, and the risks of a glove shortage outweighed the benefits of banning the gloves, Mr. Pahon said.

However, a recent economic analysis conducted by the FDA because of the critical role medical gloves play in protecting patients and health care providers showed that a powdered glove ban would not cause a glove shortage or have a significant economic impact, and that a ban would not be likely to affect medical practice since numerous non-powdered gloves options are now available, the agency noted.

The proposed rule will be available online March 22 at the Federal Register, and is open for public comment for 90 days.

If finalized, the powdered gloves and absorbable powder used for lubricating surgeons’ gloves would be removed from the marketplace.

[email protected]

The Food and Drug Administration has proposed a ban on most powdered gloves used during surgery and for patient examination, and on absorbable powder used for lubricating surgeons’ gloves.

Aerosolized glove powder on natural rubber latex gloves can cause respiratory allergic reactions, and while powdered synthetic gloves don’t present the risk of allergic reactions, all powdered gloves have been associated with numerous potentially serious adverse events, including severe airway inflammation, wound inflammation, and postsurgical adhesions, according to an FDA statement.

The proposed ban would not apply to powdered radiographic protection gloves; the agency is not aware of any such gloves that are currently on the market. The ban also would not affect non-powdered gloves.

The decision to move forward with the proposed ban was based on a determination that the affected products “are dangerous and present an unreasonable and substantial risk,” according to the statement.

In making this determination, the FDA considered the available evidence, including a literature review and the 285 comments received on a February 2011 Federal Register Notice.

That notice announced the establishment of a public docket to receive comments related to powdered gloves and followed the FDA’s receipt of two citizen petitions requesting a ban on such gloves because of the adverse health effects associated with use of the gloves. The comments overwhelmingly supported a warning or ban.

The FDA determined that the risks associated with powdered gloves cannot be corrected through new or updated labeling, and thus moved forward with the proposed ban.

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health said in the statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

In fact, should this ban be put into place, it would be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit. The benefits cited for powdered gloves were almost entirely related to greater ease of putting the gloves on and taking them off, Eric Pahon of the FDA said in an interview.

A ban on the gloves was not proposed sooner in part because when concerns were first raised about the risks associated with powdered gloves, a ban would have created a shortage, and the risks of a glove shortage outweighed the benefits of banning the gloves, Mr. Pahon said.

However, a recent economic analysis conducted by the FDA because of the critical role medical gloves play in protecting patients and health care providers showed that a powdered glove ban would not cause a glove shortage or have a significant economic impact, and that a ban would not be likely to affect medical practice since numerous non-powdered gloves options are now available, the agency noted.

The proposed rule will be available online March 22 at the Federal Register, and is open for public comment for 90 days.

If finalized, the powdered gloves and absorbable powder used for lubricating surgeons’ gloves would be removed from the marketplace.

[email protected]

The Food and Drug Administration has proposed a ban on most powdered gloves used during surgery and for patient examination, and on absorbable powder used for lubricating surgeons’ gloves.

Aerosolized glove powder on natural rubber latex gloves can cause respiratory allergic reactions, and while powdered synthetic gloves don’t present the risk of allergic reactions, all powdered gloves have been associated with numerous potentially serious adverse events, including severe airway inflammation, wound inflammation, and postsurgical adhesions, according to an FDA statement.

The proposed ban would not apply to powdered radiographic protection gloves; the agency is not aware of any such gloves that are currently on the market. The ban also would not affect non-powdered gloves.

The decision to move forward with the proposed ban was based on a determination that the affected products “are dangerous and present an unreasonable and substantial risk,” according to the statement.

In making this determination, the FDA considered the available evidence, including a literature review and the 285 comments received on a February 2011 Federal Register Notice.

That notice announced the establishment of a public docket to receive comments related to powdered gloves and followed the FDA’s receipt of two citizen petitions requesting a ban on such gloves because of the adverse health effects associated with use of the gloves. The comments overwhelmingly supported a warning or ban.

The FDA determined that the risks associated with powdered gloves cannot be corrected through new or updated labeling, and thus moved forward with the proposed ban.

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health said in the statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

In fact, should this ban be put into place, it would be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit. The benefits cited for powdered gloves were almost entirely related to greater ease of putting the gloves on and taking them off, Eric Pahon of the FDA said in an interview.

A ban on the gloves was not proposed sooner in part because when concerns were first raised about the risks associated with powdered gloves, a ban would have created a shortage, and the risks of a glove shortage outweighed the benefits of banning the gloves, Mr. Pahon said.

However, a recent economic analysis conducted by the FDA because of the critical role medical gloves play in protecting patients and health care providers showed that a powdered glove ban would not cause a glove shortage or have a significant economic impact, and that a ban would not be likely to affect medical practice since numerous non-powdered gloves options are now available, the agency noted.

The proposed rule will be available online March 22 at the Federal Register, and is open for public comment for 90 days.

If finalized, the powdered gloves and absorbable powder used for lubricating surgeons’ gloves would be removed from the marketplace.

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The federal government has launched the second phase of its HIPAA Audit Program and will soon be identifying health providers it plans to target.

For the 2016 Phase 2 HIPAA Audit Program, auditors will review policies and procedures enacted by covered entities and their business associates to meet selected standards of the Privacy, Security, and Breach Notification Rules, according to a March 21 announcement by the Department of Health & Human Services Office for Civil Rights (OCR).

©zimmytws/Thinkstock.com

Physicians and other covered entities can expect an email at some point this year requesting that updated contact information be provided to the OCR. The office will then send health providers a pre-audit questionnaire to gather data about the practice’s size, type, and operations, according to the announcement. The government will use the data as well as other information to create audit subject pools. If an entity does not respond to the OCR’s contact request or the pre-audit questionnaire, the agency will use publicly available information about the practice.

Every covered entity and business associate is eligible for an audit, the OCR noted. For Phase 2, the government plans to identify health providers and business associates that represent a wide range of health care providers, health plans, health care clearinghouses and business associates to access HIPAA compliance across the industry. Sampling criteria for auditee selection will include size of the entity, affiliation with other health care organizations, whether an organization is public or private, geographic factors, and present enforcement activity with OCR. Entities with open complaints or that are currently undergoing investigations will not be chosen.

The first set of audits will be desk audits of covered entities followed by a second round of desk audits of business associates, OCR stated. OCR plans to complete all desk audits by December 2016. A third set of audits will be on site and will examine a broader scope of requirements under the HIPAA rules. Some desk auditees may be subject to a subsequent on-site audit, the government noted.

A list of frequently asked questions about the 2016 Phase 2 HIPAA Audit Program can be found on the OCR’s website.

Round 2 of the HIPAA audits follows a pilot program launched in 2011 and 2012 by OCR that assessed HIPAA controls and processes implemented by 115 covered entities. The second phase will draw on the results and experiences learned from the pilot program, according to OCR.

[email protected]

On Twitter @legal_med

The federal government has launched the second phase of its HIPAA Audit Program and will soon be identifying health providers it plans to target.

For the 2016 Phase 2 HIPAA Audit Program, auditors will review policies and procedures enacted by covered entities and their business associates to meet selected standards of the Privacy, Security, and Breach Notification Rules, according to a March 21 announcement by the Department of Health & Human Services Office for Civil Rights (OCR).

©zimmytws/Thinkstock.com

Physicians and other covered entities can expect an email at some point this year requesting that updated contact information be provided to the OCR. The office will then send health providers a pre-audit questionnaire to gather data about the practice’s size, type, and operations, according to the announcement. The government will use the data as well as other information to create audit subject pools. If an entity does not respond to the OCR’s contact request or the pre-audit questionnaire, the agency will use publicly available information about the practice.

Every covered entity and business associate is eligible for an audit, the OCR noted. For Phase 2, the government plans to identify health providers and business associates that represent a wide range of health care providers, health plans, health care clearinghouses and business associates to access HIPAA compliance across the industry. Sampling criteria for auditee selection will include size of the entity, affiliation with other health care organizations, whether an organization is public or private, geographic factors, and present enforcement activity with OCR. Entities with open complaints or that are currently undergoing investigations will not be chosen.

The first set of audits will be desk audits of covered entities followed by a second round of desk audits of business associates, OCR stated. OCR plans to complete all desk audits by December 2016. A third set of audits will be on site and will examine a broader scope of requirements under the HIPAA rules. Some desk auditees may be subject to a subsequent on-site audit, the government noted.

A list of frequently asked questions about the 2016 Phase 2 HIPAA Audit Program can be found on the OCR’s website.

Round 2 of the HIPAA audits follows a pilot program launched in 2011 and 2012 by OCR that assessed HIPAA controls and processes implemented by 115 covered entities. The second phase will draw on the results and experiences learned from the pilot program, according to OCR.

[email protected]

On Twitter @legal_med

The federal government has launched the second phase of its HIPAA Audit Program and will soon be identifying health providers it plans to target.

For the 2016 Phase 2 HIPAA Audit Program, auditors will review policies and procedures enacted by covered entities and their business associates to meet selected standards of the Privacy, Security, and Breach Notification Rules, according to a March 21 announcement by the Department of Health & Human Services Office for Civil Rights (OCR).

©zimmytws/Thinkstock.com

Physicians and other covered entities can expect an email at some point this year requesting that updated contact information be provided to the OCR. The office will then send health providers a pre-audit questionnaire to gather data about the practice’s size, type, and operations, according to the announcement. The government will use the data as well as other information to create audit subject pools. If an entity does not respond to the OCR’s contact request or the pre-audit questionnaire, the agency will use publicly available information about the practice.

Every covered entity and business associate is eligible for an audit, the OCR noted. For Phase 2, the government plans to identify health providers and business associates that represent a wide range of health care providers, health plans, health care clearinghouses and business associates to access HIPAA compliance across the industry. Sampling criteria for auditee selection will include size of the entity, affiliation with other health care organizations, whether an organization is public or private, geographic factors, and present enforcement activity with OCR. Entities with open complaints or that are currently undergoing investigations will not be chosen.

The first set of audits will be desk audits of covered entities followed by a second round of desk audits of business associates, OCR stated. OCR plans to complete all desk audits by December 2016. A third set of audits will be on site and will examine a broader scope of requirements under the HIPAA rules. Some desk auditees may be subject to a subsequent on-site audit, the government noted.

A list of frequently asked questions about the 2016 Phase 2 HIPAA Audit Program can be found on the OCR’s website.

Round 2 of the HIPAA audits follows a pilot program launched in 2011 and 2012 by OCR that assessed HIPAA controls and processes implemented by 115 covered entities. The second phase will draw on the results and experiences learned from the pilot program, according to OCR.

[email protected]

On Twitter @legal_med

The first North American experience with a sutureless bioprosthetic aortic valve that has been available in Europe since 2005 and is well suited for minimally invasive surgery has underscored the utility of the device as an alternative to conventional aortic valve replacement (AVR) in higher-risk patients, investigators from McGill University Health Center in Montreal reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:735-742).

The investigators, led by Dr. Benoir de Varennes, reported on their experience implanting the Enable valve (Medtronic, Minneapolis) in 63 patients between August 2012 and October 2014. “The enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients,” Dr. de Varennes and colleagues said. “The early hemodynamic performance seems favorable.” Their findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available.

The Enable valve has been the subject of four European studies with 429 patients. It received its CE Mark in Europe in 2009, but is not yet commercially approved in the United States.

In the McGill study, one patient died within 30 days of receiving the valve and two died after 30 days, but none of the deaths were valve related. Four patients (6.3%) required revision during the implantation operation, and one patient required reoperation for early migration. Peak and mean gradients after surgery were 17 mm Hg and 9 mm Hg, respectively. Three patients had reported complications: Two (3.1%) required a pacemaker and one (1.6%) had a heart attack. Mean follow-up was 10 months.

Patient ages ranged from 57 to 89 years, with an average age of 80. Before surgery, all patients had calcific aortic stenosis, 43 (68%) had some degree of associated aortic regurgitation, and 46 (73%) were in New York Heart Association (NYHA) class III or IV. At the last follow-up after surgery, 61 patients (97%) were in NYHA class I.

The investigators implanted the valve through a full sternotomy or a partial upper sternotomy into the fourth intercostal space, and they used perioperative transesophageal echocardiography in all patients. They performed high-transverse aortotomy and completely excised the native valve.

The average cross-clamp time for the 30 patients who had isolated AVR was 44 minutes and 77 minutes for the 33 patients who had combined procedures. Dr. de Varennes and colleagues acknowledged the cross-clamp time for isolated AVR is “similar” to European series but “not very different” from recent reports on sutured AVR (J. Thorac. Cardiovasc. Surg. 2015;149:451-460). “This may be explained partly by the learning period of all three surgeons and the aggressive debridement of the annulus in all cases,” they said. “We think that, as further experience is gained, the clamp time will be further reduced, and this will benefit mostly higher-risk patients or those requiring concomitant procedures.”

They noted that some patients received the Enable prosthesis because of “hostile” aortas with extensive root calcification.

Dr. de Varennes disclosed he is a consultant for Medtronic and a proctor for Enable training. The coauthors had no relationships to disclose.

The first North American experience with a sutureless bioprosthetic aortic valve that has been available in Europe since 2005 and is well suited for minimally invasive surgery has underscored the utility of the device as an alternative to conventional aortic valve replacement (AVR) in higher-risk patients, investigators from McGill University Health Center in Montreal reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:735-742).

The investigators, led by Dr. Benoir de Varennes, reported on their experience implanting the Enable valve (Medtronic, Minneapolis) in 63 patients between August 2012 and October 2014. “The enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients,” Dr. de Varennes and colleagues said. “The early hemodynamic performance seems favorable.” Their findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available.

The Enable valve has been the subject of four European studies with 429 patients. It received its CE Mark in Europe in 2009, but is not yet commercially approved in the United States.

In the McGill study, one patient died within 30 days of receiving the valve and two died after 30 days, but none of the deaths were valve related. Four patients (6.3%) required revision during the implantation operation, and one patient required reoperation for early migration. Peak and mean gradients after surgery were 17 mm Hg and 9 mm Hg, respectively. Three patients had reported complications: Two (3.1%) required a pacemaker and one (1.6%) had a heart attack. Mean follow-up was 10 months.

Patient ages ranged from 57 to 89 years, with an average age of 80. Before surgery, all patients had calcific aortic stenosis, 43 (68%) had some degree of associated aortic regurgitation, and 46 (73%) were in New York Heart Association (NYHA) class III or IV. At the last follow-up after surgery, 61 patients (97%) were in NYHA class I.

The investigators implanted the valve through a full sternotomy or a partial upper sternotomy into the fourth intercostal space, and they used perioperative transesophageal echocardiography in all patients. They performed high-transverse aortotomy and completely excised the native valve.

The average cross-clamp time for the 30 patients who had isolated AVR was 44 minutes and 77 minutes for the 33 patients who had combined procedures. Dr. de Varennes and colleagues acknowledged the cross-clamp time for isolated AVR is “similar” to European series but “not very different” from recent reports on sutured AVR (J. Thorac. Cardiovasc. Surg. 2015;149:451-460). “This may be explained partly by the learning period of all three surgeons and the aggressive debridement of the annulus in all cases,” they said. “We think that, as further experience is gained, the clamp time will be further reduced, and this will benefit mostly higher-risk patients or those requiring concomitant procedures.”

They noted that some patients received the Enable prosthesis because of “hostile” aortas with extensive root calcification.

Dr. de Varennes disclosed he is a consultant for Medtronic and a proctor for Enable training. The coauthors had no relationships to disclose.

The first North American experience with a sutureless bioprosthetic aortic valve that has been available in Europe since 2005 and is well suited for minimally invasive surgery has underscored the utility of the device as an alternative to conventional aortic valve replacement (AVR) in higher-risk patients, investigators from McGill University Health Center in Montreal reported in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:735-742).

The investigators, led by Dr. Benoir de Varennes, reported on their experience implanting the Enable valve (Medtronic, Minneapolis) in 63 patients between August 2012 and October 2014. “The enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients,” Dr. de Varennes and colleagues said. “The early hemodynamic performance seems favorable.” Their findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available.

The Enable valve has been the subject of four European studies with 429 patients. It received its CE Mark in Europe in 2009, but is not yet commercially approved in the United States.

In the McGill study, one patient died within 30 days of receiving the valve and two died after 30 days, but none of the deaths were valve related. Four patients (6.3%) required revision during the implantation operation, and one patient required reoperation for early migration. Peak and mean gradients after surgery were 17 mm Hg and 9 mm Hg, respectively. Three patients had reported complications: Two (3.1%) required a pacemaker and one (1.6%) had a heart attack. Mean follow-up was 10 months.

Patient ages ranged from 57 to 89 years, with an average age of 80. Before surgery, all patients had calcific aortic stenosis, 43 (68%) had some degree of associated aortic regurgitation, and 46 (73%) were in New York Heart Association (NYHA) class III or IV. At the last follow-up after surgery, 61 patients (97%) were in NYHA class I.

The investigators implanted the valve through a full sternotomy or a partial upper sternotomy into the fourth intercostal space, and they used perioperative transesophageal echocardiography in all patients. They performed high-transverse aortotomy and completely excised the native valve.

The average cross-clamp time for the 30 patients who had isolated AVR was 44 minutes and 77 minutes for the 33 patients who had combined procedures. Dr. de Varennes and colleagues acknowledged the cross-clamp time for isolated AVR is “similar” to European series but “not very different” from recent reports on sutured AVR (J. Thorac. Cardiovasc. Surg. 2015;149:451-460). “This may be explained partly by the learning period of all three surgeons and the aggressive debridement of the annulus in all cases,” they said. “We think that, as further experience is gained, the clamp time will be further reduced, and this will benefit mostly higher-risk patients or those requiring concomitant procedures.”

They noted that some patients received the Enable prosthesis because of “hostile” aortas with extensive root calcification.

Dr. de Varennes disclosed he is a consultant for Medtronic and a proctor for Enable training. The coauthors had no relationships to disclose.