CDC Parenting Essentials: Discipline

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CDC Parenting Essentials: Discipline

As part of its “Essentials for Parenting Toddlers and Preschoolers” series, the Centers for Disease Control and Prevention has released some recommendations for parents on how to use discipline and consequences to address unwanted behavior in young children.

What happens immediately after a child’s behaviors – whether good or bad – can make the action more or less likely to occur in the future, according to the CDC. This is why appropriate consequences are so important.

© BananaStock/Thinkstock
What happens immediately after a child does something will influence the likelihood of the child repeating that same action, according to the CDC.

While praise and other types of positive consequences may be used to reward desired behavior, parents should also know when to use different types of discipline, or negative consequences, when a child has misbehaved in some way.

The CDC suggests that following negative consequences be used to discipline bad behavior and make those behaviors less likely to happen again:

1. Ignoring. Taking attention away from a child who is whining or throwing a tantrum can decrease the likelihood of the behavior continuing. When using ignoring as a form of discipline, avoid all eye contact, conversation, and attempts to get your attention.

2. Distraction. Using distractions such as games and toys can stop unwanted behaviors by redirecting the child’s focus elsewhere.

3. Natural consequences. In some situations, the negative consequences that naturally occur as the result of a bad behavior may serve as punishment in itself. For instance, if a child repeatedly bangs a toy and it breaks, the child has learned from his or her mistakes by seeing the consequence firsthand. The only caveat to allowing natural consequences to happen is to be careful that this does not put the child in danger.

4. Delay of a privilege. This method may involve taking away toys that are not handled carefully or not allowing the child to play outside until they have cleaned up their toys. This teaches the child about logical consequences that are directly related to their actions.

5. Time-Out. This involves removing the child from anything that may be distracting or hold his or her attention.

To learn more about effective discipline, visit the CDC website. To view examples of how to use discipline with toddlers, watch the video “How to Use Discipline and Consequences.”

[email protected]

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As part of its “Essentials for Parenting Toddlers and Preschoolers” series, the Centers for Disease Control and Prevention has released some recommendations for parents on how to use discipline and consequences to address unwanted behavior in young children.

What happens immediately after a child’s behaviors – whether good or bad – can make the action more or less likely to occur in the future, according to the CDC. This is why appropriate consequences are so important.

© BananaStock/Thinkstock
What happens immediately after a child does something will influence the likelihood of the child repeating that same action, according to the CDC.

While praise and other types of positive consequences may be used to reward desired behavior, parents should also know when to use different types of discipline, or negative consequences, when a child has misbehaved in some way.

The CDC suggests that following negative consequences be used to discipline bad behavior and make those behaviors less likely to happen again:

1. Ignoring. Taking attention away from a child who is whining or throwing a tantrum can decrease the likelihood of the behavior continuing. When using ignoring as a form of discipline, avoid all eye contact, conversation, and attempts to get your attention.

2. Distraction. Using distractions such as games and toys can stop unwanted behaviors by redirecting the child’s focus elsewhere.

3. Natural consequences. In some situations, the negative consequences that naturally occur as the result of a bad behavior may serve as punishment in itself. For instance, if a child repeatedly bangs a toy and it breaks, the child has learned from his or her mistakes by seeing the consequence firsthand. The only caveat to allowing natural consequences to happen is to be careful that this does not put the child in danger.

4. Delay of a privilege. This method may involve taking away toys that are not handled carefully or not allowing the child to play outside until they have cleaned up their toys. This teaches the child about logical consequences that are directly related to their actions.

5. Time-Out. This involves removing the child from anything that may be distracting or hold his or her attention.

To learn more about effective discipline, visit the CDC website. To view examples of how to use discipline with toddlers, watch the video “How to Use Discipline and Consequences.”

[email protected]

As part of its “Essentials for Parenting Toddlers and Preschoolers” series, the Centers for Disease Control and Prevention has released some recommendations for parents on how to use discipline and consequences to address unwanted behavior in young children.

What happens immediately after a child’s behaviors – whether good or bad – can make the action more or less likely to occur in the future, according to the CDC. This is why appropriate consequences are so important.

© BananaStock/Thinkstock
What happens immediately after a child does something will influence the likelihood of the child repeating that same action, according to the CDC.

While praise and other types of positive consequences may be used to reward desired behavior, parents should also know when to use different types of discipline, or negative consequences, when a child has misbehaved in some way.

The CDC suggests that following negative consequences be used to discipline bad behavior and make those behaviors less likely to happen again:

1. Ignoring. Taking attention away from a child who is whining or throwing a tantrum can decrease the likelihood of the behavior continuing. When using ignoring as a form of discipline, avoid all eye contact, conversation, and attempts to get your attention.

2. Distraction. Using distractions such as games and toys can stop unwanted behaviors by redirecting the child’s focus elsewhere.

3. Natural consequences. In some situations, the negative consequences that naturally occur as the result of a bad behavior may serve as punishment in itself. For instance, if a child repeatedly bangs a toy and it breaks, the child has learned from his or her mistakes by seeing the consequence firsthand. The only caveat to allowing natural consequences to happen is to be careful that this does not put the child in danger.

4. Delay of a privilege. This method may involve taking away toys that are not handled carefully or not allowing the child to play outside until they have cleaned up their toys. This teaches the child about logical consequences that are directly related to their actions.

5. Time-Out. This involves removing the child from anything that may be distracting or hold his or her attention.

To learn more about effective discipline, visit the CDC website. To view examples of how to use discipline with toddlers, watch the video “How to Use Discipline and Consequences.”

[email protected]

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CDC Parenting Essentials: Time-Out

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CDC Parenting Essentials: Time-Out

The last portion of the Centers for Disease Control and Prevention’s online resource, “Essentials for Parenting Toddlers and Preschoolers,” focuses on using time-out as a form of discipline, and offers guidance on how and when this method should be used with young children.

When used correctly, time-out can be very effective in stopping undesired behavior, because children dislike being bored, and time-out removes the child from all sources of fun, activity, and attention.

© Comstock/Thinkstock
When used properly, time-outs can be an effective form of discipline for young children, says the CDC.

So when should a parent use time-out?

The CDC recommends using time-out in the following situations:

1. The child has done something dangerous, such as running in the street.

2. The child has done something harmful to another child, such as fighting or biting.

3. The child has broken a family rule.

4. The child continues the misbehavior after a warning.

A warning can be used the first time the child misbehaves, and the time-out may be carried out if the child continues the unwanted behavior. CDC offers the following steps parents can take when using time-out:

1. Give a warning. Let the child know what he has done wrong, and that if he does not stop, he or she will be put in a time-out.

2. Explain why. Calmly tell the child why they are in time-out. Do not argue, scold, or talk to your child when they are sitting in time out.

3. Administer the time-out. If the child repeatedly moves or leaves the time-out space, you may need to be persistent in putting him or her back in the time-out space. Limit your interaction as much as possible when doing this.

4. End time-out. A good rule of thumb is to have the child sit in time-out for 1 minute per year of his or her age. For instance, a 4-year-old would sit in time-out for 4 minutes. Make sure your child has been quiet for at least 5 seconds at the end of time-out, and remind them what behavior you expect.

5. Praise the next good behavior the child does. This gives him or her a chance to follow directions properly.

For more information on using time out, visit the CDC website. To view examples of how to use this form of discipline, watch the video “How to Use Time-Out.”

[email protected]

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The last portion of the Centers for Disease Control and Prevention’s online resource, “Essentials for Parenting Toddlers and Preschoolers,” focuses on using time-out as a form of discipline, and offers guidance on how and when this method should be used with young children.

When used correctly, time-out can be very effective in stopping undesired behavior, because children dislike being bored, and time-out removes the child from all sources of fun, activity, and attention.

© Comstock/Thinkstock
When used properly, time-outs can be an effective form of discipline for young children, says the CDC.

So when should a parent use time-out?

The CDC recommends using time-out in the following situations:

1. The child has done something dangerous, such as running in the street.

2. The child has done something harmful to another child, such as fighting or biting.

3. The child has broken a family rule.

4. The child continues the misbehavior after a warning.

A warning can be used the first time the child misbehaves, and the time-out may be carried out if the child continues the unwanted behavior. CDC offers the following steps parents can take when using time-out:

1. Give a warning. Let the child know what he has done wrong, and that if he does not stop, he or she will be put in a time-out.

2. Explain why. Calmly tell the child why they are in time-out. Do not argue, scold, or talk to your child when they are sitting in time out.

3. Administer the time-out. If the child repeatedly moves or leaves the time-out space, you may need to be persistent in putting him or her back in the time-out space. Limit your interaction as much as possible when doing this.

4. End time-out. A good rule of thumb is to have the child sit in time-out for 1 minute per year of his or her age. For instance, a 4-year-old would sit in time-out for 4 minutes. Make sure your child has been quiet for at least 5 seconds at the end of time-out, and remind them what behavior you expect.

5. Praise the next good behavior the child does. This gives him or her a chance to follow directions properly.

For more information on using time out, visit the CDC website. To view examples of how to use this form of discipline, watch the video “How to Use Time-Out.”

[email protected]

The last portion of the Centers for Disease Control and Prevention’s online resource, “Essentials for Parenting Toddlers and Preschoolers,” focuses on using time-out as a form of discipline, and offers guidance on how and when this method should be used with young children.

When used correctly, time-out can be very effective in stopping undesired behavior, because children dislike being bored, and time-out removes the child from all sources of fun, activity, and attention.

© Comstock/Thinkstock
When used properly, time-outs can be an effective form of discipline for young children, says the CDC.

So when should a parent use time-out?

The CDC recommends using time-out in the following situations:

1. The child has done something dangerous, such as running in the street.

2. The child has done something harmful to another child, such as fighting or biting.

3. The child has broken a family rule.

4. The child continues the misbehavior after a warning.

A warning can be used the first time the child misbehaves, and the time-out may be carried out if the child continues the unwanted behavior. CDC offers the following steps parents can take when using time-out:

1. Give a warning. Let the child know what he has done wrong, and that if he does not stop, he or she will be put in a time-out.

2. Explain why. Calmly tell the child why they are in time-out. Do not argue, scold, or talk to your child when they are sitting in time out.

3. Administer the time-out. If the child repeatedly moves or leaves the time-out space, you may need to be persistent in putting him or her back in the time-out space. Limit your interaction as much as possible when doing this.

4. End time-out. A good rule of thumb is to have the child sit in time-out for 1 minute per year of his or her age. For instance, a 4-year-old would sit in time-out for 4 minutes. Make sure your child has been quiet for at least 5 seconds at the end of time-out, and remind them what behavior you expect.

5. Praise the next good behavior the child does. This gives him or her a chance to follow directions properly.

For more information on using time out, visit the CDC website. To view examples of how to use this form of discipline, watch the video “How to Use Time-Out.”

[email protected]

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LAW & MEDICINE: ‘Defective and unreasonably dangerous’

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Question: After statins had been in use for several years, data began to accumulate purporting to show that they increase the risk of diabetes. When Mrs. Smith learned that her recent diagnosis of diabetes might have something to do with the drug, she consulted a lawyer who began advertising for similar cases to consolidate them into a class action lawsuit. The legal theory (theories) seeking to prove product liability will be based on:

A. Contract law and breach of warranty.

B. Negligence in tort law.

C. Strict liability without requiring proof of fault.

D. A defective product that is unreasonably dangerous.

E. All of the above.

Answer:E. Should a prescription drug lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. The law of products liability governs this cause of action, wherein recovery is based on a number of legal theories, specifically negligence, breach of warranty, and strict liability. The latter is the most favored, as there is no need to prove fault or warranty. Products liability law also covers defective medical devices. The recent multimillion-dollar settlements and jury verdicts with Endo, Johnson & Johnson, Bard, and other manufacturers over their vaginal mesh devices are good examples.

In products liability, injured plaintiffs frequently claim a failure to warn of known risks, such as cardiovascular deaths caused by Vioxx, a nonsteroidal anti-inflammatory drug that was withdrawn in 2004. Merck, its manufacturer, has thus far won 11 and lost 3 of the cases that have gone to trial. Some of these judgments are under appeal; most notably, a Texas Court of Appeals recently reversed a $253 million award initially won by plaintiff Robert Ernst in the very first trial. However, the company has proposed $4.85 billion to settle tens of thousands of similar pending lawsuits. Other recent examples alleging failure to warn are heart attacks linked to the diabetes drug rosiglitazone and bladder cancer associated with the diabetes drug pioglitazone.

In 1963, the California Supreme Court bypassed the law of contracts and warranty in a seminal case of product-related injury, and introduced the notion of strict liability, which goes beyond simple negligence (Greenman v Yuba Power Products Inc., 377 P.2d 897 [Cal. 1963]). The strict liability approach centers on whether a product is defective and unreasonably dangerous, and it has now been adopted in virtually all jurisdictions.

The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Statins, which are powerful HMG-CoA reductase inhibitors widely used to treat hypercholesterolemia, are currently at the center of pharmaceutical products litigation.

Pfizer, the manufacturer of Lipitor (atorvastatin) has become the target of numerous lawsuits alleging that the drug causes diabetes. Lipitor is the best-selling prescription drug ever, with sales reaching $130 billion since it was approved in 1996. In the United States alone, more than 29 million people have been prescribed this medication. The drug is highly effective in lowering serum cholesterol and is proven to reduce cardiovascular deaths.

A meta-analysis in 2010 revealed an increased risk of diabetes in patients taking statins (Lancet 2010;375:735-42). Statin therapy was associated with a 9% increased risk for incident diabetes; it was calculated that treatment of 255 patients with statins for 4 years resulted in 1 extra case of diabetes. An earlier smaller study had rejected this conclusion, but other studies were in support.

In 2012, the Food and Drug Administration (FDA) required the revision of the package insert of Lipitor and other statins to warn that their use had been linked to a small increased risk of diabetes.

In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) and simvastatin (hazard ratio, 1.10). This population-based cohort study involved nondiabetic patients age 66 years or older who started statins between 1997 and 2010 (BMJ 2013;346:f2610).

These and other results, coupled with the FDA-mandated revised labeling, have spawned the filing of nearly 1,000 lawsuits by patients who developed diabetes while taking statins, especially postmenopausal women. The rapid increase in the number of lawsuits may be related to the recent decision of a federal judicial panel on multidistrict litigation to consolidate all Lipitor diabetes lawsuits into a single federal courtroom in Charleston, S.C., as a class-action suit. The first case has yet to go to trial, but is expected to do so in 2015.

 

 

Previous products liability cases implicating statins have famously involved cerivastatin (Baycol), a one-time rival to Lipitor, for causing rhabdomyolysis. The drug was pulled from the market in 2001 after it reportedly caused 31 deaths. Bayer, its manufacturer, paid about $1 billion in 2005 to settle some 3,000 cases. An example of a medication causing diabetes is quetiapine (Seroquel), an antipsychotic drug manufactured by AstraZeneca, which in 2011 agreed to pay $647 million to settle more than 28,000 lawsuits.

However, the upcoming Lipitor litigation may be more difficult for the plaintiffs to win. Among some of the medico-legal questions to be addressed are:

1) Was there prior company knowledge of the risk and a failure to warn?

2) Were the patients harmed by the drug, given that diabetes is a very common disease and may be linked more to genetics and/or an underlying metabolic syndrome in those who are hyperlipidemic, hypertensive, or obese – the very same patients likely to be on a statin?

3) Is Lipitor a defective product, and is it unreasonably dangerous?

Despite the FDA-directed change in labeling, a number of scientists and the FDA itself have emphasized that the cardiac benefits of a statin drug are greater than any small increased risk of developing diabetes.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

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Question: After statins had been in use for several years, data began to accumulate purporting to show that they increase the risk of diabetes. When Mrs. Smith learned that her recent diagnosis of diabetes might have something to do with the drug, she consulted a lawyer who began advertising for similar cases to consolidate them into a class action lawsuit. The legal theory (theories) seeking to prove product liability will be based on:

A. Contract law and breach of warranty.

B. Negligence in tort law.

C. Strict liability without requiring proof of fault.

D. A defective product that is unreasonably dangerous.

E. All of the above.

Answer:E. Should a prescription drug lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. The law of products liability governs this cause of action, wherein recovery is based on a number of legal theories, specifically negligence, breach of warranty, and strict liability. The latter is the most favored, as there is no need to prove fault or warranty. Products liability law also covers defective medical devices. The recent multimillion-dollar settlements and jury verdicts with Endo, Johnson & Johnson, Bard, and other manufacturers over their vaginal mesh devices are good examples.

In products liability, injured plaintiffs frequently claim a failure to warn of known risks, such as cardiovascular deaths caused by Vioxx, a nonsteroidal anti-inflammatory drug that was withdrawn in 2004. Merck, its manufacturer, has thus far won 11 and lost 3 of the cases that have gone to trial. Some of these judgments are under appeal; most notably, a Texas Court of Appeals recently reversed a $253 million award initially won by plaintiff Robert Ernst in the very first trial. However, the company has proposed $4.85 billion to settle tens of thousands of similar pending lawsuits. Other recent examples alleging failure to warn are heart attacks linked to the diabetes drug rosiglitazone and bladder cancer associated with the diabetes drug pioglitazone.

In 1963, the California Supreme Court bypassed the law of contracts and warranty in a seminal case of product-related injury, and introduced the notion of strict liability, which goes beyond simple negligence (Greenman v Yuba Power Products Inc., 377 P.2d 897 [Cal. 1963]). The strict liability approach centers on whether a product is defective and unreasonably dangerous, and it has now been adopted in virtually all jurisdictions.

The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Statins, which are powerful HMG-CoA reductase inhibitors widely used to treat hypercholesterolemia, are currently at the center of pharmaceutical products litigation.

Pfizer, the manufacturer of Lipitor (atorvastatin) has become the target of numerous lawsuits alleging that the drug causes diabetes. Lipitor is the best-selling prescription drug ever, with sales reaching $130 billion since it was approved in 1996. In the United States alone, more than 29 million people have been prescribed this medication. The drug is highly effective in lowering serum cholesterol and is proven to reduce cardiovascular deaths.

A meta-analysis in 2010 revealed an increased risk of diabetes in patients taking statins (Lancet 2010;375:735-42). Statin therapy was associated with a 9% increased risk for incident diabetes; it was calculated that treatment of 255 patients with statins for 4 years resulted in 1 extra case of diabetes. An earlier smaller study had rejected this conclusion, but other studies were in support.

In 2012, the Food and Drug Administration (FDA) required the revision of the package insert of Lipitor and other statins to warn that their use had been linked to a small increased risk of diabetes.

In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) and simvastatin (hazard ratio, 1.10). This population-based cohort study involved nondiabetic patients age 66 years or older who started statins between 1997 and 2010 (BMJ 2013;346:f2610).

These and other results, coupled with the FDA-mandated revised labeling, have spawned the filing of nearly 1,000 lawsuits by patients who developed diabetes while taking statins, especially postmenopausal women. The rapid increase in the number of lawsuits may be related to the recent decision of a federal judicial panel on multidistrict litigation to consolidate all Lipitor diabetes lawsuits into a single federal courtroom in Charleston, S.C., as a class-action suit. The first case has yet to go to trial, but is expected to do so in 2015.

 

 

Previous products liability cases implicating statins have famously involved cerivastatin (Baycol), a one-time rival to Lipitor, for causing rhabdomyolysis. The drug was pulled from the market in 2001 after it reportedly caused 31 deaths. Bayer, its manufacturer, paid about $1 billion in 2005 to settle some 3,000 cases. An example of a medication causing diabetes is quetiapine (Seroquel), an antipsychotic drug manufactured by AstraZeneca, which in 2011 agreed to pay $647 million to settle more than 28,000 lawsuits.

However, the upcoming Lipitor litigation may be more difficult for the plaintiffs to win. Among some of the medico-legal questions to be addressed are:

1) Was there prior company knowledge of the risk and a failure to warn?

2) Were the patients harmed by the drug, given that diabetes is a very common disease and may be linked more to genetics and/or an underlying metabolic syndrome in those who are hyperlipidemic, hypertensive, or obese – the very same patients likely to be on a statin?

3) Is Lipitor a defective product, and is it unreasonably dangerous?

Despite the FDA-directed change in labeling, a number of scientists and the FDA itself have emphasized that the cardiac benefits of a statin drug are greater than any small increased risk of developing diabetes.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: After statins had been in use for several years, data began to accumulate purporting to show that they increase the risk of diabetes. When Mrs. Smith learned that her recent diagnosis of diabetes might have something to do with the drug, she consulted a lawyer who began advertising for similar cases to consolidate them into a class action lawsuit. The legal theory (theories) seeking to prove product liability will be based on:

A. Contract law and breach of warranty.

B. Negligence in tort law.

C. Strict liability without requiring proof of fault.

D. A defective product that is unreasonably dangerous.

E. All of the above.

Answer:E. Should a prescription drug lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. The law of products liability governs this cause of action, wherein recovery is based on a number of legal theories, specifically negligence, breach of warranty, and strict liability. The latter is the most favored, as there is no need to prove fault or warranty. Products liability law also covers defective medical devices. The recent multimillion-dollar settlements and jury verdicts with Endo, Johnson & Johnson, Bard, and other manufacturers over their vaginal mesh devices are good examples.

In products liability, injured plaintiffs frequently claim a failure to warn of known risks, such as cardiovascular deaths caused by Vioxx, a nonsteroidal anti-inflammatory drug that was withdrawn in 2004. Merck, its manufacturer, has thus far won 11 and lost 3 of the cases that have gone to trial. Some of these judgments are under appeal; most notably, a Texas Court of Appeals recently reversed a $253 million award initially won by plaintiff Robert Ernst in the very first trial. However, the company has proposed $4.85 billion to settle tens of thousands of similar pending lawsuits. Other recent examples alleging failure to warn are heart attacks linked to the diabetes drug rosiglitazone and bladder cancer associated with the diabetes drug pioglitazone.

In 1963, the California Supreme Court bypassed the law of contracts and warranty in a seminal case of product-related injury, and introduced the notion of strict liability, which goes beyond simple negligence (Greenman v Yuba Power Products Inc., 377 P.2d 897 [Cal. 1963]). The strict liability approach centers on whether a product is defective and unreasonably dangerous, and it has now been adopted in virtually all jurisdictions.

The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Statins, which are powerful HMG-CoA reductase inhibitors widely used to treat hypercholesterolemia, are currently at the center of pharmaceutical products litigation.

Pfizer, the manufacturer of Lipitor (atorvastatin) has become the target of numerous lawsuits alleging that the drug causes diabetes. Lipitor is the best-selling prescription drug ever, with sales reaching $130 billion since it was approved in 1996. In the United States alone, more than 29 million people have been prescribed this medication. The drug is highly effective in lowering serum cholesterol and is proven to reduce cardiovascular deaths.

A meta-analysis in 2010 revealed an increased risk of diabetes in patients taking statins (Lancet 2010;375:735-42). Statin therapy was associated with a 9% increased risk for incident diabetes; it was calculated that treatment of 255 patients with statins for 4 years resulted in 1 extra case of diabetes. An earlier smaller study had rejected this conclusion, but other studies were in support.

In 2012, the Food and Drug Administration (FDA) required the revision of the package insert of Lipitor and other statins to warn that their use had been linked to a small increased risk of diabetes.

In 2013, a large Canadian study confirmed the increased incidence of new-onset diabetes in patients taking atorvastatin (hazard ratio, 1.22) and simvastatin (hazard ratio, 1.10). This population-based cohort study involved nondiabetic patients age 66 years or older who started statins between 1997 and 2010 (BMJ 2013;346:f2610).

These and other results, coupled with the FDA-mandated revised labeling, have spawned the filing of nearly 1,000 lawsuits by patients who developed diabetes while taking statins, especially postmenopausal women. The rapid increase in the number of lawsuits may be related to the recent decision of a federal judicial panel on multidistrict litigation to consolidate all Lipitor diabetes lawsuits into a single federal courtroom in Charleston, S.C., as a class-action suit. The first case has yet to go to trial, but is expected to do so in 2015.

 

 

Previous products liability cases implicating statins have famously involved cerivastatin (Baycol), a one-time rival to Lipitor, for causing rhabdomyolysis. The drug was pulled from the market in 2001 after it reportedly caused 31 deaths. Bayer, its manufacturer, paid about $1 billion in 2005 to settle some 3,000 cases. An example of a medication causing diabetes is quetiapine (Seroquel), an antipsychotic drug manufactured by AstraZeneca, which in 2011 agreed to pay $647 million to settle more than 28,000 lawsuits.

However, the upcoming Lipitor litigation may be more difficult for the plaintiffs to win. Among some of the medico-legal questions to be addressed are:

1) Was there prior company knowledge of the risk and a failure to warn?

2) Were the patients harmed by the drug, given that diabetes is a very common disease and may be linked more to genetics and/or an underlying metabolic syndrome in those who are hyperlipidemic, hypertensive, or obese – the very same patients likely to be on a statin?

3) Is Lipitor a defective product, and is it unreasonably dangerous?

Despite the FDA-directed change in labeling, a number of scientists and the FDA itself have emphasized that the cardiac benefits of a statin drug are greater than any small increased risk of developing diabetes.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

References

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LAW & MEDICINE: ‘Defective and unreasonably dangerous’
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Room for Improvement in Identifying, Treating Sepsis

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Despite huge strides in the treatment of heart failure, pneumonia and myocardial infarction, hospitals have a long way to go in improving care for patients with sepsis, say the authors of a recent commentary published online in JAMA.

In a related study published in July in JAMA, sepsis was found to contribute to one in every two to three hospital deaths based on mortality results from two independent patient cohorts measured between 2010 and 2012. Additionally, most instances of sepsis were present upon admission, the report notes.

For their part, hospitalists should focus on identifying the signs and symptoms of sepsis early, according to study authors Colin R. Cooke, MD, MSc, MS, and Theodore J. Iwashyna, MD, PhD, of the division of pulmonary and critical care medicine at the University of Michigan in Ann Arbor.

"When patients are admitted for an illness such as pneumonia, we put them in a bin where we know how to treat patients with pneumonia, but we may fail to recognize when they meet the criteria for sepsis," Dr. Cooke says. "If we can recognize a patient has sepsis, then we can get on top of the illness faster by delivering antibiotics and also ensuring the patient gets fluid resuscitation early in the course of the disease."

In their JAMA article, Dr. Cooke and Dr. Iwashyna call on the Centers for Medicare & Medicaid Services to develop quality mandates that would encourage hospitals to share best practices in treating sepsis. The mandates, however, shouldn't include financial penalties, which the authors say "would create perverse incentives to not report delayed diagnosis of sepsis rather than address the problem."

Visit our website for more information on identifying sepsis in hospitalized patients.

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Despite huge strides in the treatment of heart failure, pneumonia and myocardial infarction, hospitals have a long way to go in improving care for patients with sepsis, say the authors of a recent commentary published online in JAMA.

In a related study published in July in JAMA, sepsis was found to contribute to one in every two to three hospital deaths based on mortality results from two independent patient cohorts measured between 2010 and 2012. Additionally, most instances of sepsis were present upon admission, the report notes.

For their part, hospitalists should focus on identifying the signs and symptoms of sepsis early, according to study authors Colin R. Cooke, MD, MSc, MS, and Theodore J. Iwashyna, MD, PhD, of the division of pulmonary and critical care medicine at the University of Michigan in Ann Arbor.

"When patients are admitted for an illness such as pneumonia, we put them in a bin where we know how to treat patients with pneumonia, but we may fail to recognize when they meet the criteria for sepsis," Dr. Cooke says. "If we can recognize a patient has sepsis, then we can get on top of the illness faster by delivering antibiotics and also ensuring the patient gets fluid resuscitation early in the course of the disease."

In their JAMA article, Dr. Cooke and Dr. Iwashyna call on the Centers for Medicare & Medicaid Services to develop quality mandates that would encourage hospitals to share best practices in treating sepsis. The mandates, however, shouldn't include financial penalties, which the authors say "would create perverse incentives to not report delayed diagnosis of sepsis rather than address the problem."

Visit our website for more information on identifying sepsis in hospitalized patients.

Despite huge strides in the treatment of heart failure, pneumonia and myocardial infarction, hospitals have a long way to go in improving care for patients with sepsis, say the authors of a recent commentary published online in JAMA.

In a related study published in July in JAMA, sepsis was found to contribute to one in every two to three hospital deaths based on mortality results from two independent patient cohorts measured between 2010 and 2012. Additionally, most instances of sepsis were present upon admission, the report notes.

For their part, hospitalists should focus on identifying the signs and symptoms of sepsis early, according to study authors Colin R. Cooke, MD, MSc, MS, and Theodore J. Iwashyna, MD, PhD, of the division of pulmonary and critical care medicine at the University of Michigan in Ann Arbor.

"When patients are admitted for an illness such as pneumonia, we put them in a bin where we know how to treat patients with pneumonia, but we may fail to recognize when they meet the criteria for sepsis," Dr. Cooke says. "If we can recognize a patient has sepsis, then we can get on top of the illness faster by delivering antibiotics and also ensuring the patient gets fluid resuscitation early in the course of the disease."

In their JAMA article, Dr. Cooke and Dr. Iwashyna call on the Centers for Medicare & Medicaid Services to develop quality mandates that would encourage hospitals to share best practices in treating sepsis. The mandates, however, shouldn't include financial penalties, which the authors say "would create perverse incentives to not report delayed diagnosis of sepsis rather than address the problem."

Visit our website for more information on identifying sepsis in hospitalized patients.

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PEARCE-INGS: The right questions

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During an adolescent visit, we all can agree that getting answers to even the simplest of questions can be a day’s work. Despite the reason for the visit, it always is important to ask a few basic questions in hopes that it might unveil a less obvious condition, or one that potentially could cause harm later. Asking the right questions is as important as getting the right answer to make a correct diagnosis. Questions that are too general usually yield zero information for diagnostic purposes. Adolescents are concrete thinkers; therefore, if we don’t ask the question in several different ways, we are likely not to get the right answers, or any at all.

Two questions that I feel must be asked at every female-patient visit are, “When was your last period?” and “How often does your period come?” Answers to these two questions can assist in diagnosing several medical conditions that otherwise might have gone unnoticed.

Dr. Francine Pearce

Amenorrhea, or absence of menses, is established if a female has never had a period by age 15 years (primary) or has gone 6 months or greater without one (secondary). Primary amenorrhea is generally caused by genetic or anatomic abnormalities, and commonly is identified at an earlier age. But if the presentation of the genetic disorder is not classic, such as in Turner’s syndrome, it may go unnoticed and the first clue may be amenorrhea.

Pregnancy is an obvious consideration with amenorrhea. But the picture is a little less clear when light or irregular periods are present. Postmenarche menstrual cycles are commonly irregular and not without risk of pregnancy if the adolescent becomes sexually active. Also, a patient with an ectopic pregnancy tends to have oligomenorrhea before the amenorrhea. Therefore, regardless of age, if the periods are abnormal, a pregnancy test should be done.

Early polycystic ovarian syndrome (PCOS) also can present as irregular/ infrequent periods. Many of the common signs such as hirsutism or acne may be minor and not convincing. In an age where obesity is so common, a clear picture is less likely, so PCOS may not be considered. PCOS is the No. 1 cause of infertility in women, and if suspected should be worked up.

Anovulation or dysfunctional ovaries, as seen in PCOS, may not be obvious early on. As stated, oligomenorrhea is very common in the first few years following menarche, but persistent oligomenorrhea is not normal. General guidelines state that oligomenorrhea post menarche is likely to be a sign of anovulation if 1 year post menarche, less than four menstrual cycles; 2 years post menarche, less than six menstrual cycles; 3-5 years post menarche, less than eight menstrual cycles; and greater than 5 years post menarche, less than nine menstrual cycles. Heavy bleeding occurring less than every 21 days is also a sign.

Thyroid dysfunction is a common consideration when the menstrual cycle is abnormal, and we normally attribute heavy periods to hypothyroidism and amenorrhea or irregular periods to hyperthyroidism. The truth is thyroid dysfunction – regardless of whether the hormone is high or low – can present in either fashion. Other endocrine disorders – such as adrenal hyperplasia, prolactinomas, or metabolic syndromes – also disrupt the menstrual cycle, but initial presentations can be vague and only the prudent investigator will identify the disorder.

If the patient appears underweight, careful evaluation for anorexia should be done. Irregular periods present with caloric deprivation. Questions should be asked about body image to determine if this is a concern.

Once it is established that there is a menstrual dysfunction, a careful physical exam should follow. Screening labs and a pelvic ultrasound will help identify the dysfunction, but a referral to an endocrinologist still should follow if the results are equivocal or unclear.

As demonstrated, those two simple questions have the potential to unveil so many disorders that likely would go unnoticed for months to years. Every encounter is an opportunity to obtain information regardless of the chief complaint. Posing questions in several different ways lessens the likelihood that the question will be misunderstood and compensates for varied levels of intellect.

Remember, you have to ask the right question to get the right answer!

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

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During an adolescent visit, we all can agree that getting answers to even the simplest of questions can be a day’s work. Despite the reason for the visit, it always is important to ask a few basic questions in hopes that it might unveil a less obvious condition, or one that potentially could cause harm later. Asking the right questions is as important as getting the right answer to make a correct diagnosis. Questions that are too general usually yield zero information for diagnostic purposes. Adolescents are concrete thinkers; therefore, if we don’t ask the question in several different ways, we are likely not to get the right answers, or any at all.

Two questions that I feel must be asked at every female-patient visit are, “When was your last period?” and “How often does your period come?” Answers to these two questions can assist in diagnosing several medical conditions that otherwise might have gone unnoticed.

Dr. Francine Pearce

Amenorrhea, or absence of menses, is established if a female has never had a period by age 15 years (primary) or has gone 6 months or greater without one (secondary). Primary amenorrhea is generally caused by genetic or anatomic abnormalities, and commonly is identified at an earlier age. But if the presentation of the genetic disorder is not classic, such as in Turner’s syndrome, it may go unnoticed and the first clue may be amenorrhea.

Pregnancy is an obvious consideration with amenorrhea. But the picture is a little less clear when light or irregular periods are present. Postmenarche menstrual cycles are commonly irregular and not without risk of pregnancy if the adolescent becomes sexually active. Also, a patient with an ectopic pregnancy tends to have oligomenorrhea before the amenorrhea. Therefore, regardless of age, if the periods are abnormal, a pregnancy test should be done.

Early polycystic ovarian syndrome (PCOS) also can present as irregular/ infrequent periods. Many of the common signs such as hirsutism or acne may be minor and not convincing. In an age where obesity is so common, a clear picture is less likely, so PCOS may not be considered. PCOS is the No. 1 cause of infertility in women, and if suspected should be worked up.

Anovulation or dysfunctional ovaries, as seen in PCOS, may not be obvious early on. As stated, oligomenorrhea is very common in the first few years following menarche, but persistent oligomenorrhea is not normal. General guidelines state that oligomenorrhea post menarche is likely to be a sign of anovulation if 1 year post menarche, less than four menstrual cycles; 2 years post menarche, less than six menstrual cycles; 3-5 years post menarche, less than eight menstrual cycles; and greater than 5 years post menarche, less than nine menstrual cycles. Heavy bleeding occurring less than every 21 days is also a sign.

Thyroid dysfunction is a common consideration when the menstrual cycle is abnormal, and we normally attribute heavy periods to hypothyroidism and amenorrhea or irregular periods to hyperthyroidism. The truth is thyroid dysfunction – regardless of whether the hormone is high or low – can present in either fashion. Other endocrine disorders – such as adrenal hyperplasia, prolactinomas, or metabolic syndromes – also disrupt the menstrual cycle, but initial presentations can be vague and only the prudent investigator will identify the disorder.

If the patient appears underweight, careful evaluation for anorexia should be done. Irregular periods present with caloric deprivation. Questions should be asked about body image to determine if this is a concern.

Once it is established that there is a menstrual dysfunction, a careful physical exam should follow. Screening labs and a pelvic ultrasound will help identify the dysfunction, but a referral to an endocrinologist still should follow if the results are equivocal or unclear.

As demonstrated, those two simple questions have the potential to unveil so many disorders that likely would go unnoticed for months to years. Every encounter is an opportunity to obtain information regardless of the chief complaint. Posing questions in several different ways lessens the likelihood that the question will be misunderstood and compensates for varied levels of intellect.

Remember, you have to ask the right question to get the right answer!

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

During an adolescent visit, we all can agree that getting answers to even the simplest of questions can be a day’s work. Despite the reason for the visit, it always is important to ask a few basic questions in hopes that it might unveil a less obvious condition, or one that potentially could cause harm later. Asking the right questions is as important as getting the right answer to make a correct diagnosis. Questions that are too general usually yield zero information for diagnostic purposes. Adolescents are concrete thinkers; therefore, if we don’t ask the question in several different ways, we are likely not to get the right answers, or any at all.

Two questions that I feel must be asked at every female-patient visit are, “When was your last period?” and “How often does your period come?” Answers to these two questions can assist in diagnosing several medical conditions that otherwise might have gone unnoticed.

Dr. Francine Pearce

Amenorrhea, or absence of menses, is established if a female has never had a period by age 15 years (primary) or has gone 6 months or greater without one (secondary). Primary amenorrhea is generally caused by genetic or anatomic abnormalities, and commonly is identified at an earlier age. But if the presentation of the genetic disorder is not classic, such as in Turner’s syndrome, it may go unnoticed and the first clue may be amenorrhea.

Pregnancy is an obvious consideration with amenorrhea. But the picture is a little less clear when light or irregular periods are present. Postmenarche menstrual cycles are commonly irregular and not without risk of pregnancy if the adolescent becomes sexually active. Also, a patient with an ectopic pregnancy tends to have oligomenorrhea before the amenorrhea. Therefore, regardless of age, if the periods are abnormal, a pregnancy test should be done.

Early polycystic ovarian syndrome (PCOS) also can present as irregular/ infrequent periods. Many of the common signs such as hirsutism or acne may be minor and not convincing. In an age where obesity is so common, a clear picture is less likely, so PCOS may not be considered. PCOS is the No. 1 cause of infertility in women, and if suspected should be worked up.

Anovulation or dysfunctional ovaries, as seen in PCOS, may not be obvious early on. As stated, oligomenorrhea is very common in the first few years following menarche, but persistent oligomenorrhea is not normal. General guidelines state that oligomenorrhea post menarche is likely to be a sign of anovulation if 1 year post menarche, less than four menstrual cycles; 2 years post menarche, less than six menstrual cycles; 3-5 years post menarche, less than eight menstrual cycles; and greater than 5 years post menarche, less than nine menstrual cycles. Heavy bleeding occurring less than every 21 days is also a sign.

Thyroid dysfunction is a common consideration when the menstrual cycle is abnormal, and we normally attribute heavy periods to hypothyroidism and amenorrhea or irregular periods to hyperthyroidism. The truth is thyroid dysfunction – regardless of whether the hormone is high or low – can present in either fashion. Other endocrine disorders – such as adrenal hyperplasia, prolactinomas, or metabolic syndromes – also disrupt the menstrual cycle, but initial presentations can be vague and only the prudent investigator will identify the disorder.

If the patient appears underweight, careful evaluation for anorexia should be done. Irregular periods present with caloric deprivation. Questions should be asked about body image to determine if this is a concern.

Once it is established that there is a menstrual dysfunction, a careful physical exam should follow. Screening labs and a pelvic ultrasound will help identify the dysfunction, but a referral to an endocrinologist still should follow if the results are equivocal or unclear.

As demonstrated, those two simple questions have the potential to unveil so many disorders that likely would go unnoticed for months to years. Every encounter is an opportunity to obtain information regardless of the chief complaint. Posing questions in several different ways lessens the likelihood that the question will be misunderstood and compensates for varied levels of intellect.

Remember, you have to ask the right question to get the right answer!

Dr. Pearce is a pediatrician in Frankfort, Ill. E-mail her at [email protected].

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Primary-Care Physicians Weigh in on Quality of Care Transitions

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A new study on transitions of care gives hospitalists a view from the other side.

Published recently online in the Journal of Hospital Medicine, the authors surveyed 22 primary-care physician leaders in California-based post-discharge clinics and asked them about ways to improve care transitions.

Physicians' responses focused on several areas that need work, most notably aligned financial incentives, regulations to standardize interoperability among electronic health records (EHR) and data sharing, and more opportunities for professional networking, the authors note.

Although the qualitative study takes a broad view of the healthcare system, its lead author says hospitalists should view "systems change" as a long-term goal achievable via incremental improvements that can start now.

"National policy change is needed to move the needle for the whole health system," says hospitalist Oanh Kieu Nguyen, MD, MAS, of the University of Texas Southwestern Medical Center in Dallas. "But locally, you can innovate within these domains and start to make changes to improve practice settings more immediately. National policy to align financial incentives and improve EHR interoperability will be key to helping local changes take hold and spread across systems. Otherwise, there will continue to be a lot of variability and fragmentation around care transitions on a national level."

Dr. Nguyen, who has practiced as both a hospitalist and PCP, says that because policies and studies on post-discharge care transitions primarily have focused on the hospital perspective, it is important to gain an understanding of the primary-care point of view.

"As a hospitalist, it's really easy to get caught up in just wanting to get patients teed up and sent home. Once they're out, we think they're no longer really our problem," Dr. Nguyen adds. "It's easy to forget that primary care is an important part of the other side of the equation. The way our healthcare system is designed doesn't really give physicians an incentive to look at the whole picture of a patient across all the environments they're in."

Many hospitalists are sharing their challenges and successes in care transitions through HMX. Join the conversation now.

Visit our website for more information on transitions of care.
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A new study on transitions of care gives hospitalists a view from the other side.

Published recently online in the Journal of Hospital Medicine, the authors surveyed 22 primary-care physician leaders in California-based post-discharge clinics and asked them about ways to improve care transitions.

Physicians' responses focused on several areas that need work, most notably aligned financial incentives, regulations to standardize interoperability among electronic health records (EHR) and data sharing, and more opportunities for professional networking, the authors note.

Although the qualitative study takes a broad view of the healthcare system, its lead author says hospitalists should view "systems change" as a long-term goal achievable via incremental improvements that can start now.

"National policy change is needed to move the needle for the whole health system," says hospitalist Oanh Kieu Nguyen, MD, MAS, of the University of Texas Southwestern Medical Center in Dallas. "But locally, you can innovate within these domains and start to make changes to improve practice settings more immediately. National policy to align financial incentives and improve EHR interoperability will be key to helping local changes take hold and spread across systems. Otherwise, there will continue to be a lot of variability and fragmentation around care transitions on a national level."

Dr. Nguyen, who has practiced as both a hospitalist and PCP, says that because policies and studies on post-discharge care transitions primarily have focused on the hospital perspective, it is important to gain an understanding of the primary-care point of view.

"As a hospitalist, it's really easy to get caught up in just wanting to get patients teed up and sent home. Once they're out, we think they're no longer really our problem," Dr. Nguyen adds. "It's easy to forget that primary care is an important part of the other side of the equation. The way our healthcare system is designed doesn't really give physicians an incentive to look at the whole picture of a patient across all the environments they're in."

Many hospitalists are sharing their challenges and successes in care transitions through HMX. Join the conversation now.

Visit our website for more information on transitions of care.

A new study on transitions of care gives hospitalists a view from the other side.

Published recently online in the Journal of Hospital Medicine, the authors surveyed 22 primary-care physician leaders in California-based post-discharge clinics and asked them about ways to improve care transitions.

Physicians' responses focused on several areas that need work, most notably aligned financial incentives, regulations to standardize interoperability among electronic health records (EHR) and data sharing, and more opportunities for professional networking, the authors note.

Although the qualitative study takes a broad view of the healthcare system, its lead author says hospitalists should view "systems change" as a long-term goal achievable via incremental improvements that can start now.

"National policy change is needed to move the needle for the whole health system," says hospitalist Oanh Kieu Nguyen, MD, MAS, of the University of Texas Southwestern Medical Center in Dallas. "But locally, you can innovate within these domains and start to make changes to improve practice settings more immediately. National policy to align financial incentives and improve EHR interoperability will be key to helping local changes take hold and spread across systems. Otherwise, there will continue to be a lot of variability and fragmentation around care transitions on a national level."

Dr. Nguyen, who has practiced as both a hospitalist and PCP, says that because policies and studies on post-discharge care transitions primarily have focused on the hospital perspective, it is important to gain an understanding of the primary-care point of view.

"As a hospitalist, it's really easy to get caught up in just wanting to get patients teed up and sent home. Once they're out, we think they're no longer really our problem," Dr. Nguyen adds. "It's easy to forget that primary care is an important part of the other side of the equation. The way our healthcare system is designed doesn't really give physicians an incentive to look at the whole picture of a patient across all the environments they're in."

Many hospitalists are sharing their challenges and successes in care transitions through HMX. Join the conversation now.

Visit our website for more information on transitions of care.
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Gaining control over fecal incontinence

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Fecal incontinence is a devastating and isolating condition. Sales of adult diapers are a $7 billion global market and the fastest-growing household products business. Which is where a lot of our patients with this condition remain – at home.

Fecal incontinence (FI) is a condition characterized by continuous or recurrent uncontrolled passage of fecal material. The prevalence may be as high as 15%. Risk factors include physical disabilities, dementia, diabetes, urinary incontinence, chronic diarrhea, and multiparity. One-third of patients will talk to us about it. Which for some of us may be suitable, given our inability to offer good treatments.

If patients do mention it, evaluation involves taking a good history. We need to differentiate incontinence from fecal urgency and frequency. Anorectal examination should look for a bilateral anal wink (absence suggests nerve damage). Some form of endoscopic examination should be performed in most patients. Further evaluation/referral will be based upon findings.

Treatment includes improving stool consistency (e.g., fiber for loose stool) and reducing frequency (e.g., loperamide for diarrhea), and this is generally where I start. Hyoscyamine may be helpful for post-meal leakage. Scheduled defecation and amitriptyline may be of benefit to some patients.

Dr. Henri Damon of Hospices Civils de Lyon, France, and his colleagues conducted a multicenter study of perineal retraining for FI (Dig. Liver Dis. 2014;46:237-42). The intervention included perineal retraining and biofeedback. The protocol was based upon 20 sessions of 30 minutes performed within a 4-month period. The intervention was standardized. Eighty patients were included in the control group, with 77 in the biofeedback group.

The success rate was significantly higher in the biofeedback group (57% vs. 37%; P < .021). Stool frequency, leakage, and urgency significantly decreased. Perineal retraining was significantly associated with a higher chance of self-rated improvement.

The take-home message is that perineal retraining is an effective component of FI treatment. Combining it with improved perianal skin hygiene, bowel habit ritualization, and the addition of fiber as a bulking agent and loperamide for diarrhea offers the greatest hope for patients suffering from this challenging condition.

Our job is to figure out where and how our patients can access the level of expertise needed to do the training.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.

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Fecal incontinence is a devastating and isolating condition. Sales of adult diapers are a $7 billion global market and the fastest-growing household products business. Which is where a lot of our patients with this condition remain – at home.

Fecal incontinence (FI) is a condition characterized by continuous or recurrent uncontrolled passage of fecal material. The prevalence may be as high as 15%. Risk factors include physical disabilities, dementia, diabetes, urinary incontinence, chronic diarrhea, and multiparity. One-third of patients will talk to us about it. Which for some of us may be suitable, given our inability to offer good treatments.

If patients do mention it, evaluation involves taking a good history. We need to differentiate incontinence from fecal urgency and frequency. Anorectal examination should look for a bilateral anal wink (absence suggests nerve damage). Some form of endoscopic examination should be performed in most patients. Further evaluation/referral will be based upon findings.

Treatment includes improving stool consistency (e.g., fiber for loose stool) and reducing frequency (e.g., loperamide for diarrhea), and this is generally where I start. Hyoscyamine may be helpful for post-meal leakage. Scheduled defecation and amitriptyline may be of benefit to some patients.

Dr. Henri Damon of Hospices Civils de Lyon, France, and his colleagues conducted a multicenter study of perineal retraining for FI (Dig. Liver Dis. 2014;46:237-42). The intervention included perineal retraining and biofeedback. The protocol was based upon 20 sessions of 30 minutes performed within a 4-month period. The intervention was standardized. Eighty patients were included in the control group, with 77 in the biofeedback group.

The success rate was significantly higher in the biofeedback group (57% vs. 37%; P < .021). Stool frequency, leakage, and urgency significantly decreased. Perineal retraining was significantly associated with a higher chance of self-rated improvement.

The take-home message is that perineal retraining is an effective component of FI treatment. Combining it with improved perianal skin hygiene, bowel habit ritualization, and the addition of fiber as a bulking agent and loperamide for diarrhea offers the greatest hope for patients suffering from this challenging condition.

Our job is to figure out where and how our patients can access the level of expertise needed to do the training.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.

Fecal incontinence is a devastating and isolating condition. Sales of adult diapers are a $7 billion global market and the fastest-growing household products business. Which is where a lot of our patients with this condition remain – at home.

Fecal incontinence (FI) is a condition characterized by continuous or recurrent uncontrolled passage of fecal material. The prevalence may be as high as 15%. Risk factors include physical disabilities, dementia, diabetes, urinary incontinence, chronic diarrhea, and multiparity. One-third of patients will talk to us about it. Which for some of us may be suitable, given our inability to offer good treatments.

If patients do mention it, evaluation involves taking a good history. We need to differentiate incontinence from fecal urgency and frequency. Anorectal examination should look for a bilateral anal wink (absence suggests nerve damage). Some form of endoscopic examination should be performed in most patients. Further evaluation/referral will be based upon findings.

Treatment includes improving stool consistency (e.g., fiber for loose stool) and reducing frequency (e.g., loperamide for diarrhea), and this is generally where I start. Hyoscyamine may be helpful for post-meal leakage. Scheduled defecation and amitriptyline may be of benefit to some patients.

Dr. Henri Damon of Hospices Civils de Lyon, France, and his colleagues conducted a multicenter study of perineal retraining for FI (Dig. Liver Dis. 2014;46:237-42). The intervention included perineal retraining and biofeedback. The protocol was based upon 20 sessions of 30 minutes performed within a 4-month period. The intervention was standardized. Eighty patients were included in the control group, with 77 in the biofeedback group.

The success rate was significantly higher in the biofeedback group (57% vs. 37%; P < .021). Stool frequency, leakage, and urgency significantly decreased. Perineal retraining was significantly associated with a higher chance of self-rated improvement.

The take-home message is that perineal retraining is an effective component of FI treatment. Combining it with improved perianal skin hygiene, bowel habit ritualization, and the addition of fiber as a bulking agent and loperamide for diarrhea offers the greatest hope for patients suffering from this challenging condition.

Our job is to figure out where and how our patients can access the level of expertise needed to do the training.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician.

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In defense of the lowly case report

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A few months ago, a nephrologist called me about a young, previously healthy health care worker who presented with an altered mental status, rapidly progressive renal failure, and rhabdomyolysis. It was an unusual combination of symptoms, and he had already ruled out the first things that came to my mind: drug toxicity, illicit drug use, thrombotic thrombocytopenic purpura-hemolytic-uremic syndrome. He wanted to know if I’d ever seen myositis present in this manner. I had not and could not think of ever having come across this as a possibility.

After powwowing with my bosses and coming up empty handed, I did what I do in these circumstances: I went to PubMed. Apart from illicit drug use, it seemed this constellation of symptoms was quite unusual. But there was one case report in an obscure emergency medicine journal from the 1980s, or perhaps it was the 1970s, of a patient that presented in just this manner and turned out to have Legionnaires’ disease.

I called the nephrologist back and told him about the case report. Although the patient had not reported a cough, he ran the test, and it came back positive.

Randomized, controlled trials are the philosopher’s stone of the scientific method, turning individual anecdotes into generalizable information, useful for large numbers of patients. But when doctors see unusual cases, we are often left with nothing but our own store of medical knowledge, informed by experience, imagination, and inquisitiveness. Intelligent speculation, to be sure, but hardly comforting to patient and physician alike.

It can be reassuring to know that other people have come across such unusual cases, just as it can be gratifying to know that our peers are interested in hearing our stories as well.

Counterfactuals are hard to come by in medicine, and we will never know what would have happened to the patient had I not seen that case report on PubMed. But the bias against case reports is such that it is probable that many illnesses remain undiagnosed simply because similar cases were deemed unworthy of publication.

There ought to be a repository of well-curated case reports. We are, all of us, made up of stories after all. And the stories that we tell are the art that temper this science we call Medicine.

Dr. Chan is a rheumatologist in Pawtucket, R.I.

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A few months ago, a nephrologist called me about a young, previously healthy health care worker who presented with an altered mental status, rapidly progressive renal failure, and rhabdomyolysis. It was an unusual combination of symptoms, and he had already ruled out the first things that came to my mind: drug toxicity, illicit drug use, thrombotic thrombocytopenic purpura-hemolytic-uremic syndrome. He wanted to know if I’d ever seen myositis present in this manner. I had not and could not think of ever having come across this as a possibility.

After powwowing with my bosses and coming up empty handed, I did what I do in these circumstances: I went to PubMed. Apart from illicit drug use, it seemed this constellation of symptoms was quite unusual. But there was one case report in an obscure emergency medicine journal from the 1980s, or perhaps it was the 1970s, of a patient that presented in just this manner and turned out to have Legionnaires’ disease.

I called the nephrologist back and told him about the case report. Although the patient had not reported a cough, he ran the test, and it came back positive.

Randomized, controlled trials are the philosopher’s stone of the scientific method, turning individual anecdotes into generalizable information, useful for large numbers of patients. But when doctors see unusual cases, we are often left with nothing but our own store of medical knowledge, informed by experience, imagination, and inquisitiveness. Intelligent speculation, to be sure, but hardly comforting to patient and physician alike.

It can be reassuring to know that other people have come across such unusual cases, just as it can be gratifying to know that our peers are interested in hearing our stories as well.

Counterfactuals are hard to come by in medicine, and we will never know what would have happened to the patient had I not seen that case report on PubMed. But the bias against case reports is such that it is probable that many illnesses remain undiagnosed simply because similar cases were deemed unworthy of publication.

There ought to be a repository of well-curated case reports. We are, all of us, made up of stories after all. And the stories that we tell are the art that temper this science we call Medicine.

Dr. Chan is a rheumatologist in Pawtucket, R.I.

A few months ago, a nephrologist called me about a young, previously healthy health care worker who presented with an altered mental status, rapidly progressive renal failure, and rhabdomyolysis. It was an unusual combination of symptoms, and he had already ruled out the first things that came to my mind: drug toxicity, illicit drug use, thrombotic thrombocytopenic purpura-hemolytic-uremic syndrome. He wanted to know if I’d ever seen myositis present in this manner. I had not and could not think of ever having come across this as a possibility.

After powwowing with my bosses and coming up empty handed, I did what I do in these circumstances: I went to PubMed. Apart from illicit drug use, it seemed this constellation of symptoms was quite unusual. But there was one case report in an obscure emergency medicine journal from the 1980s, or perhaps it was the 1970s, of a patient that presented in just this manner and turned out to have Legionnaires’ disease.

I called the nephrologist back and told him about the case report. Although the patient had not reported a cough, he ran the test, and it came back positive.

Randomized, controlled trials are the philosopher’s stone of the scientific method, turning individual anecdotes into generalizable information, useful for large numbers of patients. But when doctors see unusual cases, we are often left with nothing but our own store of medical knowledge, informed by experience, imagination, and inquisitiveness. Intelligent speculation, to be sure, but hardly comforting to patient and physician alike.

It can be reassuring to know that other people have come across such unusual cases, just as it can be gratifying to know that our peers are interested in hearing our stories as well.

Counterfactuals are hard to come by in medicine, and we will never know what would have happened to the patient had I not seen that case report on PubMed. But the bias against case reports is such that it is probable that many illnesses remain undiagnosed simply because similar cases were deemed unworthy of publication.

There ought to be a repository of well-curated case reports. We are, all of us, made up of stories after all. And the stories that we tell are the art that temper this science we call Medicine.

Dr. Chan is a rheumatologist in Pawtucket, R.I.

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RECESS suggests RBC age doesn’t affect outcomes

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Blood for transfusion

Credit: UAB Hospital

PHILADELPHIA—As the medical community continues to debate whether transfusing older blood has a negative outcome on patients, results of the RECESS trial add fuel to the fire.

The study showed no significant differences in clinical outcomes between cardiac surgery patients who received newer red blood cells (RBCs) and those who received older RBCs.

There were no differences in multi-organ dysfunction scores (MODS), mortality rates, or the incidence of serious adverse events.

Marie E. Stein, MD, of the University of Minnesota in Minneapolis, presented the results of RECESS at the AABB Annual Meeting 2014 (abstract P2-020A).

The findings contradict results from another recent study presented at the Canadian Cardiovascular Congress.

“There are many studies of the effects of red blood cell storage duration on clinical outcomes, most of which are observational and include only a few randomized trials to date,” Dr Stein noted. “When studying cardiac surgery patients, some studies have found significant adverse outcomes of subjects who are transfused with red cells stored for a longer duration compared to shorter duration, and other studies have not.”

“Based on this equipoise, the primary hypothesis for RECESS was that there would be an important difference between the effect of transfusing shorter-storage-age-duration red cells compared to transfusing longer-storage-age-duration red cells on clinical outcomes in cardiac surgery patients.”

Patient characteristics

Dr Stein and her colleagues enrolled 1481 patients who were 12 years of age and older, weighed 40 kg or more, were undergoing complex cardiac surgery, and were considered “highly likely” to be transfused. They had to have a TRUST score of 3 or greater if they were older than 18 years of age, but this was not required for children.

Patients were split into two groups: those set to receive RBCs stored for 10 days or fewer and those set to receive RBCs stored for 21 days or more. Patients were stratified by age (those 12 to 17 years vs patients 18 and older) and according to whether they were in the intensive care unit prior to surgery. They were balanced by site as well.

In all, there were 538 subjects evaluable for the newer RBC arm and 560 subjects evaluable for the older RBC arm. (Subjects were evaluable if they underwent surgery and received at least 1 RBC unit.) The median patient age was 73 and 72 years, respectively, and males made up 42% and 44% of the patients, respectively.

The same percentage of patients in each arm—96%—underwent cardiopulmonary bypass, and 23% of patients in each arm underwent coronary artery bypass grafting. Seventeen percent of patients in the newer RBC arm and 14% in the older RBC arm underwent valve surgery only.

“Red cells were leukoreduced, stored in additive solution, and provided according to storage duration arm assignment for all pre-op, post-op, and intra-operative transfusions through day 28, discharge, or death, whichever occurred first,” Dr Stein noted.

The number of RBC units did not differ significantly between the two arms (P=0.80), and there was a comparable number of highly transfused subjects in each arm (P=0.81).

Eighty-seven percent of patients in the newer RBC arm and 89% in the older RBC arm received all their RBC units as assigned (P=0.35).

Six percent and 8%, respectively, received 1 or more unit aged 11 to 20 days but none belonging to the opposite arm to which they were assigned. Five percent and 4%, respectively, received 1 or more RBC unit from the opposite arm to which they were assigned.

“There was a 20-day difference in the mean storage duration between the two arms: 8 vs 28 days,” Dr Stein pointed out.

 

 

Outcomes

The study’s primary outcome was the change in multi-organ dysfunction score (ΔMODS) at 7 days. The MODS system includes assessments of respiratory, renal, hepatic, cardiovascular, hematologic, and neurologic function.

“The MODS system was chosen as the primary endpoint because the data elements are objective and readily available,” Dr Stein said. “MODS also incorporates organ dysfunction and not just frank organ failure. It correlates with mortality, with length of stay, and does incorporate death. MODS has been validated in other studies and has been used in other transfusion trials, including TRICC.”

To calculate 7-day ΔMODS, the researchers identified the worst score for each organ system through day 7 after surgery, discharge, or death. The 7-day MODS was the sum of the worst score for each organ system, and the 7-day ΔMODS was the pre-surgery MODS subtracted from the 7-day MODS.

Secondary outcomes were the 28-day ΔMODS, 28-day mortality, and the incidence of serious adverse events.

There was no significant difference between the arms with regard to 7-day or 28-day ΔMODS.

For the 7-day ΔMODS, the mean was 8.5±3.6 in the newer RBC arm and 8.7±3.6 in the older RBC arm. The unadjusted difference and the difference adjusted for baseline MODS were both -0.02.

For the 28-day ΔMODS, the mean was 8.7±4.0 in the newer RBC arm and 9.1±4.2 in the older RBC arm. The unadjusted difference and the difference adjusted for baseline MODS were both -0.3.

There was no significant difference between the arms in time to death (P=0.50), 7-day mortality (P=0.43), or 28-day mortality (P=0.57). The rate of 7-day mortality was 2.8% in the newer RBC arm and 2.0% in the older RBC arm. The 28-day mortality was 4.4% and 5.3%, respectively.

There was no significant difference in the percentage of subjects with 1 or more serious adverse events. The rate was 53% in the newer RBC arm and 51% in the older RBC arm (P=0.72).

Taking these results together, Dr Stein concluded that differences in the storage duration of RBCs did not translate to significant differences in “key clinical outcomes.”

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Blood for transfusion

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PHILADELPHIA—As the medical community continues to debate whether transfusing older blood has a negative outcome on patients, results of the RECESS trial add fuel to the fire.

The study showed no significant differences in clinical outcomes between cardiac surgery patients who received newer red blood cells (RBCs) and those who received older RBCs.

There were no differences in multi-organ dysfunction scores (MODS), mortality rates, or the incidence of serious adverse events.

Marie E. Stein, MD, of the University of Minnesota in Minneapolis, presented the results of RECESS at the AABB Annual Meeting 2014 (abstract P2-020A).

The findings contradict results from another recent study presented at the Canadian Cardiovascular Congress.

“There are many studies of the effects of red blood cell storage duration on clinical outcomes, most of which are observational and include only a few randomized trials to date,” Dr Stein noted. “When studying cardiac surgery patients, some studies have found significant adverse outcomes of subjects who are transfused with red cells stored for a longer duration compared to shorter duration, and other studies have not.”

“Based on this equipoise, the primary hypothesis for RECESS was that there would be an important difference between the effect of transfusing shorter-storage-age-duration red cells compared to transfusing longer-storage-age-duration red cells on clinical outcomes in cardiac surgery patients.”

Patient characteristics

Dr Stein and her colleagues enrolled 1481 patients who were 12 years of age and older, weighed 40 kg or more, were undergoing complex cardiac surgery, and were considered “highly likely” to be transfused. They had to have a TRUST score of 3 or greater if they were older than 18 years of age, but this was not required for children.

Patients were split into two groups: those set to receive RBCs stored for 10 days or fewer and those set to receive RBCs stored for 21 days or more. Patients were stratified by age (those 12 to 17 years vs patients 18 and older) and according to whether they were in the intensive care unit prior to surgery. They were balanced by site as well.

In all, there were 538 subjects evaluable for the newer RBC arm and 560 subjects evaluable for the older RBC arm. (Subjects were evaluable if they underwent surgery and received at least 1 RBC unit.) The median patient age was 73 and 72 years, respectively, and males made up 42% and 44% of the patients, respectively.

The same percentage of patients in each arm—96%—underwent cardiopulmonary bypass, and 23% of patients in each arm underwent coronary artery bypass grafting. Seventeen percent of patients in the newer RBC arm and 14% in the older RBC arm underwent valve surgery only.

“Red cells were leukoreduced, stored in additive solution, and provided according to storage duration arm assignment for all pre-op, post-op, and intra-operative transfusions through day 28, discharge, or death, whichever occurred first,” Dr Stein noted.

The number of RBC units did not differ significantly between the two arms (P=0.80), and there was a comparable number of highly transfused subjects in each arm (P=0.81).

Eighty-seven percent of patients in the newer RBC arm and 89% in the older RBC arm received all their RBC units as assigned (P=0.35).

Six percent and 8%, respectively, received 1 or more unit aged 11 to 20 days but none belonging to the opposite arm to which they were assigned. Five percent and 4%, respectively, received 1 or more RBC unit from the opposite arm to which they were assigned.

“There was a 20-day difference in the mean storage duration between the two arms: 8 vs 28 days,” Dr Stein pointed out.

 

 

Outcomes

The study’s primary outcome was the change in multi-organ dysfunction score (ΔMODS) at 7 days. The MODS system includes assessments of respiratory, renal, hepatic, cardiovascular, hematologic, and neurologic function.

“The MODS system was chosen as the primary endpoint because the data elements are objective and readily available,” Dr Stein said. “MODS also incorporates organ dysfunction and not just frank organ failure. It correlates with mortality, with length of stay, and does incorporate death. MODS has been validated in other studies and has been used in other transfusion trials, including TRICC.”

To calculate 7-day ΔMODS, the researchers identified the worst score for each organ system through day 7 after surgery, discharge, or death. The 7-day MODS was the sum of the worst score for each organ system, and the 7-day ΔMODS was the pre-surgery MODS subtracted from the 7-day MODS.

Secondary outcomes were the 28-day ΔMODS, 28-day mortality, and the incidence of serious adverse events.

There was no significant difference between the arms with regard to 7-day or 28-day ΔMODS.

For the 7-day ΔMODS, the mean was 8.5±3.6 in the newer RBC arm and 8.7±3.6 in the older RBC arm. The unadjusted difference and the difference adjusted for baseline MODS were both -0.02.

For the 28-day ΔMODS, the mean was 8.7±4.0 in the newer RBC arm and 9.1±4.2 in the older RBC arm. The unadjusted difference and the difference adjusted for baseline MODS were both -0.3.

There was no significant difference between the arms in time to death (P=0.50), 7-day mortality (P=0.43), or 28-day mortality (P=0.57). The rate of 7-day mortality was 2.8% in the newer RBC arm and 2.0% in the older RBC arm. The 28-day mortality was 4.4% and 5.3%, respectively.

There was no significant difference in the percentage of subjects with 1 or more serious adverse events. The rate was 53% in the newer RBC arm and 51% in the older RBC arm (P=0.72).

Taking these results together, Dr Stein concluded that differences in the storage duration of RBCs did not translate to significant differences in “key clinical outcomes.”

Blood for transfusion

Credit: UAB Hospital

PHILADELPHIA—As the medical community continues to debate whether transfusing older blood has a negative outcome on patients, results of the RECESS trial add fuel to the fire.

The study showed no significant differences in clinical outcomes between cardiac surgery patients who received newer red blood cells (RBCs) and those who received older RBCs.

There were no differences in multi-organ dysfunction scores (MODS), mortality rates, or the incidence of serious adverse events.

Marie E. Stein, MD, of the University of Minnesota in Minneapolis, presented the results of RECESS at the AABB Annual Meeting 2014 (abstract P2-020A).

The findings contradict results from another recent study presented at the Canadian Cardiovascular Congress.

“There are many studies of the effects of red blood cell storage duration on clinical outcomes, most of which are observational and include only a few randomized trials to date,” Dr Stein noted. “When studying cardiac surgery patients, some studies have found significant adverse outcomes of subjects who are transfused with red cells stored for a longer duration compared to shorter duration, and other studies have not.”

“Based on this equipoise, the primary hypothesis for RECESS was that there would be an important difference between the effect of transfusing shorter-storage-age-duration red cells compared to transfusing longer-storage-age-duration red cells on clinical outcomes in cardiac surgery patients.”

Patient characteristics

Dr Stein and her colleagues enrolled 1481 patients who were 12 years of age and older, weighed 40 kg or more, were undergoing complex cardiac surgery, and were considered “highly likely” to be transfused. They had to have a TRUST score of 3 or greater if they were older than 18 years of age, but this was not required for children.

Patients were split into two groups: those set to receive RBCs stored for 10 days or fewer and those set to receive RBCs stored for 21 days or more. Patients were stratified by age (those 12 to 17 years vs patients 18 and older) and according to whether they were in the intensive care unit prior to surgery. They were balanced by site as well.

In all, there were 538 subjects evaluable for the newer RBC arm and 560 subjects evaluable for the older RBC arm. (Subjects were evaluable if they underwent surgery and received at least 1 RBC unit.) The median patient age was 73 and 72 years, respectively, and males made up 42% and 44% of the patients, respectively.

The same percentage of patients in each arm—96%—underwent cardiopulmonary bypass, and 23% of patients in each arm underwent coronary artery bypass grafting. Seventeen percent of patients in the newer RBC arm and 14% in the older RBC arm underwent valve surgery only.

“Red cells were leukoreduced, stored in additive solution, and provided according to storage duration arm assignment for all pre-op, post-op, and intra-operative transfusions through day 28, discharge, or death, whichever occurred first,” Dr Stein noted.

The number of RBC units did not differ significantly between the two arms (P=0.80), and there was a comparable number of highly transfused subjects in each arm (P=0.81).

Eighty-seven percent of patients in the newer RBC arm and 89% in the older RBC arm received all their RBC units as assigned (P=0.35).

Six percent and 8%, respectively, received 1 or more unit aged 11 to 20 days but none belonging to the opposite arm to which they were assigned. Five percent and 4%, respectively, received 1 or more RBC unit from the opposite arm to which they were assigned.

“There was a 20-day difference in the mean storage duration between the two arms: 8 vs 28 days,” Dr Stein pointed out.

 

 

Outcomes

The study’s primary outcome was the change in multi-organ dysfunction score (ΔMODS) at 7 days. The MODS system includes assessments of respiratory, renal, hepatic, cardiovascular, hematologic, and neurologic function.

“The MODS system was chosen as the primary endpoint because the data elements are objective and readily available,” Dr Stein said. “MODS also incorporates organ dysfunction and not just frank organ failure. It correlates with mortality, with length of stay, and does incorporate death. MODS has been validated in other studies and has been used in other transfusion trials, including TRICC.”

To calculate 7-day ΔMODS, the researchers identified the worst score for each organ system through day 7 after surgery, discharge, or death. The 7-day MODS was the sum of the worst score for each organ system, and the 7-day ΔMODS was the pre-surgery MODS subtracted from the 7-day MODS.

Secondary outcomes were the 28-day ΔMODS, 28-day mortality, and the incidence of serious adverse events.

There was no significant difference between the arms with regard to 7-day or 28-day ΔMODS.

For the 7-day ΔMODS, the mean was 8.5±3.6 in the newer RBC arm and 8.7±3.6 in the older RBC arm. The unadjusted difference and the difference adjusted for baseline MODS were both -0.02.

For the 28-day ΔMODS, the mean was 8.7±4.0 in the newer RBC arm and 9.1±4.2 in the older RBC arm. The unadjusted difference and the difference adjusted for baseline MODS were both -0.3.

There was no significant difference between the arms in time to death (P=0.50), 7-day mortality (P=0.43), or 28-day mortality (P=0.57). The rate of 7-day mortality was 2.8% in the newer RBC arm and 2.0% in the older RBC arm. The 28-day mortality was 4.4% and 5.3%, respectively.

There was no significant difference in the percentage of subjects with 1 or more serious adverse events. The rate was 53% in the newer RBC arm and 51% in the older RBC arm (P=0.72).

Taking these results together, Dr Stein concluded that differences in the storage duration of RBCs did not translate to significant differences in “key clinical outcomes.”

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Banning Smoking in Tribal Casinos

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In American Indian (AI) communities that have casinos, health is improving, thanks to more employment and less poverty. But it is not all good news because casino workers (of whom 1 in 4 is an AI) and patrons are still exposed to secondhand smoke in many casinos, say researchers from the Great Lakes Inter-Tribal Council (GLITC) in Lac du Flambeau (LDF), Wisconsin; Northwest Portland Area Indian Health Board, in Oregon; and the University of Oklahoma in Tulsa. Tribal casinos are exempt from statewide bans on smoking because of tribal sovereignty. However, though smoking has declined in other segments of the population, it has not among AIs, where the incidence is 40%—more than twice that of the general U.S. population. Moreover, the tobacco industry has increasingly targeted tribal casinos, the researchers add.

Only 6 of 237 tribes operating casinos have voluntarily implemented casino-wide smoking bans. The tribal community is aiming to do something about that, though. The GLITC, a consortium of 12 member tribes in Wisconsin and Upper Michigan, and the LDF tribal nation, a member of GLITC, collaborated with the Lake of the Torches Resort Casino in northern Wisconsin to survey casino patrons to find out whether a smoking ban could get passed.

The project team’s analysis was based on survey responses from 957 casino patrons who were questioned about their opinions on smoking, secondhand smoke, and smoking bans. Most respondents were white and nonsmokers. A majority (69%) were bothered to some extent by smoke in the casino, and 81% believed secondhand smoke is harmful. Those who preferred a smoke-free casino were older, white, and gambled less. Over half (54%) said they were likely to visit more often, 28% said they were indifferent to a smoke-free casino, and 18% said they would visit less if the casino were smoke free. 

The researchers cite other studies that have found that only 20% of casino patrons smoke. They also say smoking bans are not cited as reasons people visit casinos less, and smoking bans do not result in revenue loss for casinos.

This is the first study to employ a community-based and tribally led approach. The access would not have been possible without the “significant trust” between GLITC and the LDF tribal nation, the researchers say. The casino, owned and operated by the tribal nation whose members indirectly benefit from casino revenue, was responsive to community concerns about secondhand smoke, they add. This suggests that tribal communities may be “uniquely suited…to play a leadership role in a smoke-free casino movement.”

Source
Brokenleg IS, Barber TK, Bennett NL, Peart Boyce S, Blue Bird Jernigan V. Am J Prev Med. 2014;47(3):290-299.
doi: 10.1016/j.amepre.2014.04.006.

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In American Indian (AI) communities that have casinos, health is improving, thanks to more employment and less poverty. But it is not all good news because casino workers (of whom 1 in 4 is an AI) and patrons are still exposed to secondhand smoke in many casinos, say researchers from the Great Lakes Inter-Tribal Council (GLITC) in Lac du Flambeau (LDF), Wisconsin; Northwest Portland Area Indian Health Board, in Oregon; and the University of Oklahoma in Tulsa. Tribal casinos are exempt from statewide bans on smoking because of tribal sovereignty. However, though smoking has declined in other segments of the population, it has not among AIs, where the incidence is 40%—more than twice that of the general U.S. population. Moreover, the tobacco industry has increasingly targeted tribal casinos, the researchers add.

Only 6 of 237 tribes operating casinos have voluntarily implemented casino-wide smoking bans. The tribal community is aiming to do something about that, though. The GLITC, a consortium of 12 member tribes in Wisconsin and Upper Michigan, and the LDF tribal nation, a member of GLITC, collaborated with the Lake of the Torches Resort Casino in northern Wisconsin to survey casino patrons to find out whether a smoking ban could get passed.

The project team’s analysis was based on survey responses from 957 casino patrons who were questioned about their opinions on smoking, secondhand smoke, and smoking bans. Most respondents were white and nonsmokers. A majority (69%) were bothered to some extent by smoke in the casino, and 81% believed secondhand smoke is harmful. Those who preferred a smoke-free casino were older, white, and gambled less. Over half (54%) said they were likely to visit more often, 28% said they were indifferent to a smoke-free casino, and 18% said they would visit less if the casino were smoke free. 

The researchers cite other studies that have found that only 20% of casino patrons smoke. They also say smoking bans are not cited as reasons people visit casinos less, and smoking bans do not result in revenue loss for casinos.

This is the first study to employ a community-based and tribally led approach. The access would not have been possible without the “significant trust” between GLITC and the LDF tribal nation, the researchers say. The casino, owned and operated by the tribal nation whose members indirectly benefit from casino revenue, was responsive to community concerns about secondhand smoke, they add. This suggests that tribal communities may be “uniquely suited…to play a leadership role in a smoke-free casino movement.”

Source
Brokenleg IS, Barber TK, Bennett NL, Peart Boyce S, Blue Bird Jernigan V. Am J Prev Med. 2014;47(3):290-299.
doi: 10.1016/j.amepre.2014.04.006.

In American Indian (AI) communities that have casinos, health is improving, thanks to more employment and less poverty. But it is not all good news because casino workers (of whom 1 in 4 is an AI) and patrons are still exposed to secondhand smoke in many casinos, say researchers from the Great Lakes Inter-Tribal Council (GLITC) in Lac du Flambeau (LDF), Wisconsin; Northwest Portland Area Indian Health Board, in Oregon; and the University of Oklahoma in Tulsa. Tribal casinos are exempt from statewide bans on smoking because of tribal sovereignty. However, though smoking has declined in other segments of the population, it has not among AIs, where the incidence is 40%—more than twice that of the general U.S. population. Moreover, the tobacco industry has increasingly targeted tribal casinos, the researchers add.

Only 6 of 237 tribes operating casinos have voluntarily implemented casino-wide smoking bans. The tribal community is aiming to do something about that, though. The GLITC, a consortium of 12 member tribes in Wisconsin and Upper Michigan, and the LDF tribal nation, a member of GLITC, collaborated with the Lake of the Torches Resort Casino in northern Wisconsin to survey casino patrons to find out whether a smoking ban could get passed.

The project team’s analysis was based on survey responses from 957 casino patrons who were questioned about their opinions on smoking, secondhand smoke, and smoking bans. Most respondents were white and nonsmokers. A majority (69%) were bothered to some extent by smoke in the casino, and 81% believed secondhand smoke is harmful. Those who preferred a smoke-free casino were older, white, and gambled less. Over half (54%) said they were likely to visit more often, 28% said they were indifferent to a smoke-free casino, and 18% said they would visit less if the casino were smoke free. 

The researchers cite other studies that have found that only 20% of casino patrons smoke. They also say smoking bans are not cited as reasons people visit casinos less, and smoking bans do not result in revenue loss for casinos.

This is the first study to employ a community-based and tribally led approach. The access would not have been possible without the “significant trust” between GLITC and the LDF tribal nation, the researchers say. The casino, owned and operated by the tribal nation whose members indirectly benefit from casino revenue, was responsive to community concerns about secondhand smoke, they add. This suggests that tribal communities may be “uniquely suited…to play a leadership role in a smoke-free casino movement.”

Source
Brokenleg IS, Barber TK, Bennett NL, Peart Boyce S, Blue Bird Jernigan V. Am J Prev Med. 2014;47(3):290-299.
doi: 10.1016/j.amepre.2014.04.006.

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