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Law & Medicine: Discovery rule and statute of limitations

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Question: In July 2002, a patient in California underwent surgery for a herniated T8-9 disk, but the surgeon instead removed the T6-7 and T7-8 disks. On Sept. 11, 2002, the surgeon discussed with the patient the MRI findings showing his mistake. On Sept. 17, 2003, the patient filed a malpractice lawsuit, just 6 days beyond California’s 1-year limitations period. California subscribes to the discovery rule, that is, a cause of action accrues only when a claimant discovers or should have discovered injury was the result of negligence.

Which of the following choices is best?

A. The lawsuit filed Sept. 17, 2003, is time barred, as the negligent surgery took place in July 2002.

B. On its face, the lawsuit was filed too late, being 1 year and 6 days after the Sept. 11, 2002, discussion date.

C. The lawsuit was timely filed, so long as the claimant can prove he was out of town for more than 6 days of that year.

D. The patient should sue as an action in battery, which has a longer statute of limitations.

E. All choices except A are correct.

Answer: E. At common law, there was no time limit that barred a plaintiff from bringing a claim, although an equitable doctrine of laches existed to foreclose an action that had long lapsed. Statutory changes in the law now require that lawsuits be brought in a timely manner so that the evidence remains fresh, accurate, and reliable.

Dr. S.Y. Tan

Another reason is to provide repose to the wrongdoer, that is, relief from worrying for an indefinite period of time whether a lawsuit will be brought. This time period, during which a lawsuit must be filed or it will be barred, is termed the statute of limitations. It is 2 years for the tort of negligence in most jurisdictions, with states such as California and Tennessee placing a 1-year limit on medical malpractice claims. In California, the running of the statute is tolled (temporarily halted) for the days a claimant is out of state.

The above case scenario is taken from Kaplan v. Mamelak,1 where the plaintiff’s lawsuit was not barred to allow him to identify the number of days he was out of town. The court also permitted a cause of action in battery, which is covered under a longer statute of limitations, as well as one sounding in malpractice.

Patients who are injured from malpractice may not always be aware that a negligent act had taken place, and some injuries may remain latent for a long period. Recognizing this, statutes of limitation emphasize the date when the plaintiff first discovered that the injury resulted from negligence. This is termed the discovery rule.

Stated more formally, the limitations period commences at the time the cause of action (negligence or other wrongs) accrues, and this usually means when the claimant knew (actual knowledge) or should have known (constructive knowledge).

The rule, in the words of one court, is meant to balance the need for “prompt assertion of claims” against a policy “favoring adjudication of claims on the merits and ensuring that a party with a valid claim will be given an opportunity to present it.”

As is typical of other jurisdictions, Hawaii sought to clarify the discovery rule in a series of court cases, beginning with Yoshizaki v. Hilo Hospital,2 where the court deemed a cause of action “does not begin to run until the plaintiff knew or should have known of the defendant’s negligence.”

Subsequently, Hawaii’s Intermediate Court of Appeals explained that the state’s 2-year limitations statute commences when the plaintiff discovers, or through the use of reasonable diligence should have discovered, 1) the damage; 2) the violation of the duty; and 3) the causal connection between the violation of the duty and the damage.3

The court subsequently held that the rule prevents the running of the limitations period until “the plaintiff [has] knowledge of those facts which are necessary for an actionable claim.”4 In 1999, the Hawaii Supreme Court clarified that it was “factual knowledge,” rather than “legal knowledge,” that starts the clock running, and that legal knowledge of a defendant’s negligence was not required.5

More recently, litigation over the time barring of claims was evident in Moon v. Rhode,6 where Dr. Clarissa Rhode and Central Illinois Radiological Associates were sued for negligently misreading a patient’s CT scans.

The 90-year-old patient, Kathryn Moon, was admitted to Proctor Hospital May 18, 2009, and died 11 days later following surgery and complications of fluid overload and a pneumoperitoneum. Dr. Rhode, a radiologist, interpreted two CT scans, which an independent expert in 2013 determined were negligently misread. A lawsuit was then brought against Dr. Rhode, who was not a named defendant when the plaintiff had timely filed a medical negligence action back in 2011 against the surgeon and the attending doctor.

 

 

The court of appeals held that the discovery rule can be applied to wrongful death and survival actions, and that the statute of limitations begins to run when the plaintiff knows or should have known that the death was “wrongfully caused.” However, this did not necessarily mean knowledge of a specific defendant’s negligent conduct or knowledge of the existence of a cause of action.

The court stated: “Plaintiff filed his complaint long after he became possessed with sufficient information, which put him on inquiry to determine whether actionable conduct was involved.” The court ruled that the relevant inquiry was not when the plaintiff became aware that Dr. Rhode may have committed medical negligence, but when any defendant may have committed medical negligence against the patient Kathryn. The case is currently on appeal to the Supreme Court of Illinois.

In addition to the discovery rule, other situations may toll the limitations period. One example is fraudulent concealment of a right of action, where the statute may be tolled during the period of concealment. And in all jurisdictions, the running of the time period is halted in malpractice complaints involving treatment of a minor until that minor reaches a certain age, such as age of majority, or after a stipulated number of years, for example, 6 years.

Occasionally, a health care provider may overlook an important tolling provision. California, for example, has a rule that any “payment” made to an injured party must be accompanied by a written statement regarding the applicable statute of limitations.

In the recent Coastal Surgical Institute v. Blevins case,7 the defendant surgeon made a payment of $4,118.23 for medical expenses incurred by an unrepresented plaintiff, but had neglected to attach a release or a written notice regarding the statute of limitations. The plaintiff subsequently decided to file a lawsuit, even though more than a year – the statutory period – had lapsed.

Under the facts, the limitation period was tolled, and the trial court allowed the case to go forward, ultimately finding liability and awarding damages of $500,000, later reduced to $285,114. The court of appeals affirmed the decision.

This case has prompted MIEC, a malpractice insurance carrier, to emphasize putting in writing the restrictions imposed by the limitations statute to any unrepresented patient. MIEC also warned that the term “payment” might be construed liberally, citing case examples that include a free counseling session and the provision of specialized care for a student injured by a school’s gym equipment.

References

1. Kaplan v. Mamelak, 162 Cal. App. 4th 637 (2008).

2. Yoshizaki v. Hilo Hospital, 433 P.2d 220 (1967).

3. Jacoby v. Kaiser Foundation Hospital, 622 P.2d 613 (1981).

4. Yamaguchi v. Queen’s Medical Center, 648 P.2d 689 (1982).

5. Buck v. Miles, 971 P.2d 717 (1999).

6. Moon v. Rhode, IL. 2015 App. 3d 130613.

7. Coastal Surgical Institute v. Blevins, 232 Cal. App. 4th 1321 (2015).

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at [email protected].

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Question: In July 2002, a patient in California underwent surgery for a herniated T8-9 disk, but the surgeon instead removed the T6-7 and T7-8 disks. On Sept. 11, 2002, the surgeon discussed with the patient the MRI findings showing his mistake. On Sept. 17, 2003, the patient filed a malpractice lawsuit, just 6 days beyond California’s 1-year limitations period. California subscribes to the discovery rule, that is, a cause of action accrues only when a claimant discovers or should have discovered injury was the result of negligence.

Which of the following choices is best?

A. The lawsuit filed Sept. 17, 2003, is time barred, as the negligent surgery took place in July 2002.

B. On its face, the lawsuit was filed too late, being 1 year and 6 days after the Sept. 11, 2002, discussion date.

C. The lawsuit was timely filed, so long as the claimant can prove he was out of town for more than 6 days of that year.

D. The patient should sue as an action in battery, which has a longer statute of limitations.

E. All choices except A are correct.

Answer: E. At common law, there was no time limit that barred a plaintiff from bringing a claim, although an equitable doctrine of laches existed to foreclose an action that had long lapsed. Statutory changes in the law now require that lawsuits be brought in a timely manner so that the evidence remains fresh, accurate, and reliable.

Dr. S.Y. Tan

Another reason is to provide repose to the wrongdoer, that is, relief from worrying for an indefinite period of time whether a lawsuit will be brought. This time period, during which a lawsuit must be filed or it will be barred, is termed the statute of limitations. It is 2 years for the tort of negligence in most jurisdictions, with states such as California and Tennessee placing a 1-year limit on medical malpractice claims. In California, the running of the statute is tolled (temporarily halted) for the days a claimant is out of state.

The above case scenario is taken from Kaplan v. Mamelak,1 where the plaintiff’s lawsuit was not barred to allow him to identify the number of days he was out of town. The court also permitted a cause of action in battery, which is covered under a longer statute of limitations, as well as one sounding in malpractice.

Patients who are injured from malpractice may not always be aware that a negligent act had taken place, and some injuries may remain latent for a long period. Recognizing this, statutes of limitation emphasize the date when the plaintiff first discovered that the injury resulted from negligence. This is termed the discovery rule.

Stated more formally, the limitations period commences at the time the cause of action (negligence or other wrongs) accrues, and this usually means when the claimant knew (actual knowledge) or should have known (constructive knowledge).

The rule, in the words of one court, is meant to balance the need for “prompt assertion of claims” against a policy “favoring adjudication of claims on the merits and ensuring that a party with a valid claim will be given an opportunity to present it.”

As is typical of other jurisdictions, Hawaii sought to clarify the discovery rule in a series of court cases, beginning with Yoshizaki v. Hilo Hospital,2 where the court deemed a cause of action “does not begin to run until the plaintiff knew or should have known of the defendant’s negligence.”

Subsequently, Hawaii’s Intermediate Court of Appeals explained that the state’s 2-year limitations statute commences when the plaintiff discovers, or through the use of reasonable diligence should have discovered, 1) the damage; 2) the violation of the duty; and 3) the causal connection between the violation of the duty and the damage.3

The court subsequently held that the rule prevents the running of the limitations period until “the plaintiff [has] knowledge of those facts which are necessary for an actionable claim.”4 In 1999, the Hawaii Supreme Court clarified that it was “factual knowledge,” rather than “legal knowledge,” that starts the clock running, and that legal knowledge of a defendant’s negligence was not required.5

More recently, litigation over the time barring of claims was evident in Moon v. Rhode,6 where Dr. Clarissa Rhode and Central Illinois Radiological Associates were sued for negligently misreading a patient’s CT scans.

The 90-year-old patient, Kathryn Moon, was admitted to Proctor Hospital May 18, 2009, and died 11 days later following surgery and complications of fluid overload and a pneumoperitoneum. Dr. Rhode, a radiologist, interpreted two CT scans, which an independent expert in 2013 determined were negligently misread. A lawsuit was then brought against Dr. Rhode, who was not a named defendant when the plaintiff had timely filed a medical negligence action back in 2011 against the surgeon and the attending doctor.

 

 

The court of appeals held that the discovery rule can be applied to wrongful death and survival actions, and that the statute of limitations begins to run when the plaintiff knows or should have known that the death was “wrongfully caused.” However, this did not necessarily mean knowledge of a specific defendant’s negligent conduct or knowledge of the existence of a cause of action.

The court stated: “Plaintiff filed his complaint long after he became possessed with sufficient information, which put him on inquiry to determine whether actionable conduct was involved.” The court ruled that the relevant inquiry was not when the plaintiff became aware that Dr. Rhode may have committed medical negligence, but when any defendant may have committed medical negligence against the patient Kathryn. The case is currently on appeal to the Supreme Court of Illinois.

In addition to the discovery rule, other situations may toll the limitations period. One example is fraudulent concealment of a right of action, where the statute may be tolled during the period of concealment. And in all jurisdictions, the running of the time period is halted in malpractice complaints involving treatment of a minor until that minor reaches a certain age, such as age of majority, or after a stipulated number of years, for example, 6 years.

Occasionally, a health care provider may overlook an important tolling provision. California, for example, has a rule that any “payment” made to an injured party must be accompanied by a written statement regarding the applicable statute of limitations.

In the recent Coastal Surgical Institute v. Blevins case,7 the defendant surgeon made a payment of $4,118.23 for medical expenses incurred by an unrepresented plaintiff, but had neglected to attach a release or a written notice regarding the statute of limitations. The plaintiff subsequently decided to file a lawsuit, even though more than a year – the statutory period – had lapsed.

Under the facts, the limitation period was tolled, and the trial court allowed the case to go forward, ultimately finding liability and awarding damages of $500,000, later reduced to $285,114. The court of appeals affirmed the decision.

This case has prompted MIEC, a malpractice insurance carrier, to emphasize putting in writing the restrictions imposed by the limitations statute to any unrepresented patient. MIEC also warned that the term “payment” might be construed liberally, citing case examples that include a free counseling session and the provision of specialized care for a student injured by a school’s gym equipment.

References

1. Kaplan v. Mamelak, 162 Cal. App. 4th 637 (2008).

2. Yoshizaki v. Hilo Hospital, 433 P.2d 220 (1967).

3. Jacoby v. Kaiser Foundation Hospital, 622 P.2d 613 (1981).

4. Yamaguchi v. Queen’s Medical Center, 648 P.2d 689 (1982).

5. Buck v. Miles, 971 P.2d 717 (1999).

6. Moon v. Rhode, IL. 2015 App. 3d 130613.

7. Coastal Surgical Institute v. Blevins, 232 Cal. App. 4th 1321 (2015).

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at [email protected].

Question: In July 2002, a patient in California underwent surgery for a herniated T8-9 disk, but the surgeon instead removed the T6-7 and T7-8 disks. On Sept. 11, 2002, the surgeon discussed with the patient the MRI findings showing his mistake. On Sept. 17, 2003, the patient filed a malpractice lawsuit, just 6 days beyond California’s 1-year limitations period. California subscribes to the discovery rule, that is, a cause of action accrues only when a claimant discovers or should have discovered injury was the result of negligence.

Which of the following choices is best?

A. The lawsuit filed Sept. 17, 2003, is time barred, as the negligent surgery took place in July 2002.

B. On its face, the lawsuit was filed too late, being 1 year and 6 days after the Sept. 11, 2002, discussion date.

C. The lawsuit was timely filed, so long as the claimant can prove he was out of town for more than 6 days of that year.

D. The patient should sue as an action in battery, which has a longer statute of limitations.

E. All choices except A are correct.

Answer: E. At common law, there was no time limit that barred a plaintiff from bringing a claim, although an equitable doctrine of laches existed to foreclose an action that had long lapsed. Statutory changes in the law now require that lawsuits be brought in a timely manner so that the evidence remains fresh, accurate, and reliable.

Dr. S.Y. Tan

Another reason is to provide repose to the wrongdoer, that is, relief from worrying for an indefinite period of time whether a lawsuit will be brought. This time period, during which a lawsuit must be filed or it will be barred, is termed the statute of limitations. It is 2 years for the tort of negligence in most jurisdictions, with states such as California and Tennessee placing a 1-year limit on medical malpractice claims. In California, the running of the statute is tolled (temporarily halted) for the days a claimant is out of state.

The above case scenario is taken from Kaplan v. Mamelak,1 where the plaintiff’s lawsuit was not barred to allow him to identify the number of days he was out of town. The court also permitted a cause of action in battery, which is covered under a longer statute of limitations, as well as one sounding in malpractice.

Patients who are injured from malpractice may not always be aware that a negligent act had taken place, and some injuries may remain latent for a long period. Recognizing this, statutes of limitation emphasize the date when the plaintiff first discovered that the injury resulted from negligence. This is termed the discovery rule.

Stated more formally, the limitations period commences at the time the cause of action (negligence or other wrongs) accrues, and this usually means when the claimant knew (actual knowledge) or should have known (constructive knowledge).

The rule, in the words of one court, is meant to balance the need for “prompt assertion of claims” against a policy “favoring adjudication of claims on the merits and ensuring that a party with a valid claim will be given an opportunity to present it.”

As is typical of other jurisdictions, Hawaii sought to clarify the discovery rule in a series of court cases, beginning with Yoshizaki v. Hilo Hospital,2 where the court deemed a cause of action “does not begin to run until the plaintiff knew or should have known of the defendant’s negligence.”

Subsequently, Hawaii’s Intermediate Court of Appeals explained that the state’s 2-year limitations statute commences when the plaintiff discovers, or through the use of reasonable diligence should have discovered, 1) the damage; 2) the violation of the duty; and 3) the causal connection between the violation of the duty and the damage.3

The court subsequently held that the rule prevents the running of the limitations period until “the plaintiff [has] knowledge of those facts which are necessary for an actionable claim.”4 In 1999, the Hawaii Supreme Court clarified that it was “factual knowledge,” rather than “legal knowledge,” that starts the clock running, and that legal knowledge of a defendant’s negligence was not required.5

More recently, litigation over the time barring of claims was evident in Moon v. Rhode,6 where Dr. Clarissa Rhode and Central Illinois Radiological Associates were sued for negligently misreading a patient’s CT scans.

The 90-year-old patient, Kathryn Moon, was admitted to Proctor Hospital May 18, 2009, and died 11 days later following surgery and complications of fluid overload and a pneumoperitoneum. Dr. Rhode, a radiologist, interpreted two CT scans, which an independent expert in 2013 determined were negligently misread. A lawsuit was then brought against Dr. Rhode, who was not a named defendant when the plaintiff had timely filed a medical negligence action back in 2011 against the surgeon and the attending doctor.

 

 

The court of appeals held that the discovery rule can be applied to wrongful death and survival actions, and that the statute of limitations begins to run when the plaintiff knows or should have known that the death was “wrongfully caused.” However, this did not necessarily mean knowledge of a specific defendant’s negligent conduct or knowledge of the existence of a cause of action.

The court stated: “Plaintiff filed his complaint long after he became possessed with sufficient information, which put him on inquiry to determine whether actionable conduct was involved.” The court ruled that the relevant inquiry was not when the plaintiff became aware that Dr. Rhode may have committed medical negligence, but when any defendant may have committed medical negligence against the patient Kathryn. The case is currently on appeal to the Supreme Court of Illinois.

In addition to the discovery rule, other situations may toll the limitations period. One example is fraudulent concealment of a right of action, where the statute may be tolled during the period of concealment. And in all jurisdictions, the running of the time period is halted in malpractice complaints involving treatment of a minor until that minor reaches a certain age, such as age of majority, or after a stipulated number of years, for example, 6 years.

Occasionally, a health care provider may overlook an important tolling provision. California, for example, has a rule that any “payment” made to an injured party must be accompanied by a written statement regarding the applicable statute of limitations.

In the recent Coastal Surgical Institute v. Blevins case,7 the defendant surgeon made a payment of $4,118.23 for medical expenses incurred by an unrepresented plaintiff, but had neglected to attach a release or a written notice regarding the statute of limitations. The plaintiff subsequently decided to file a lawsuit, even though more than a year – the statutory period – had lapsed.

Under the facts, the limitation period was tolled, and the trial court allowed the case to go forward, ultimately finding liability and awarding damages of $500,000, later reduced to $285,114. The court of appeals affirmed the decision.

This case has prompted MIEC, a malpractice insurance carrier, to emphasize putting in writing the restrictions imposed by the limitations statute to any unrepresented patient. MIEC also warned that the term “payment” might be construed liberally, citing case examples that include a free counseling session and the provision of specialized care for a student injured by a school’s gym equipment.

References

1. Kaplan v. Mamelak, 162 Cal. App. 4th 637 (2008).

2. Yoshizaki v. Hilo Hospital, 433 P.2d 220 (1967).

3. Jacoby v. Kaiser Foundation Hospital, 622 P.2d 613 (1981).

4. Yamaguchi v. Queen’s Medical Center, 648 P.2d 689 (1982).

5. Buck v. Miles, 971 P.2d 717 (1999).

6. Moon v. Rhode, IL. 2015 App. 3d 130613.

7. Coastal Surgical Institute v. Blevins, 232 Cal. App. 4th 1321 (2015).

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at [email protected].

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Choosing the transaxillary or supraclavicular approach for neurogenic TOS

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The transaxillary approach has its advantages

I began my vascular fellowship at UCLA on July 1, 1986 – the previous day I was a chief surgery resident running a VA general surgery service where my last emergency case that evening was an abdominal peroneal resection for perforated rectal cancer! I was delighted to begin my fellowship, and learned that on Tuesdays I would be operating with Herb Machleder, MD – the expert on thoracic outlet syndrome (TOS) who perfected the transaxillary approach. I remembered his service from when I was an intern holding the patient arm up by cradling it my arms while he and the fellow removed the rib and identified each structure—subclavius tendon, subclavian vein, anterior scalene muscle, subclavian artery brachial plexus and any other abnormal band or structure present. The rib was removed in entirety to ensure an excellent outcome and to prevent any possibility of recurrence from scarring to the brachial plexus to a portion of retained rib. Dr. Machleder then went on to design a rib retractor to better support the arm and afford superb visibility.

As I began my career, I included transaxillary first rib resection as part of my practice for all forms of TOS, except when we needed to replace the subclavian artery because of an aneurysm or thrombosis. In those instances, we would employ the supraclavicular approach with an infraclavicular incision when necessary. In my 5 years as chief of the division of vascular surgery at UCLA (1998-2003), we saw many patients with TOS thanks to the legacy and practice of Dr. Machleder. We performed approximately 300 such operations between three of us and saw probably three to four times as many patients in clinic who did not need surgery to treat their TOS or other conditions.

Dr. Julie A. Freischlag

When I arrived at Johns Hopkins as department chair in 2003, a robust thoracic outlet program did not exist there, so we began one. By the time I left in 2014, we were seeing 5-7 new patients per week and were operating on 125 per year, of which half were neurogenic. Ying Wei Lum, MD, and Maggie Arnold, MD, are continuing that practice at Johns Hopkins today.

The most important point about the “approach” for neurogenic thoracic outlet syndrome is whether or not you should operate. At Johns Hopkins, we only operated on about a third of those who presented to us with neurogenic symptoms, as 60%-70% will get better with a thoracic outlet–focused physical therapy regimen. We developed a protocol for this, which we actually handed to the patients as the prescription as they came from all over for our opinion on their conditions. We are doing the same at UC Davis.

We have published a great deal about patients who do not do as well with the surgical approach to neurogenic TOS. These patients include those over the age of 40 and those who have had symptoms for more than 10 years, as they tend to be quite debilitated and never quite recover fully from the operation.1 A scalene block with lidocaine can predict success in patients with the operation, and I use it in older patients or those with multiple complaints.2 At UC Davis, our pain service can perform the block with ultrasound guidance, which is easier for the patient.

Other patients who do not do well with the surgical approach to neurogenic TOS include those with other comorbidities such as cervical spine disease and shoulder abnormalities or injuries, as well as those with a severe dependence on pain medication due to such medical issues as complex pain syndrome or myofasciitis caused by comorbid diseases.3

These patients cannot adequately perform the requisite postoperative physical therapy to completely improve, and some can take up to a year to get range of motion and strength back. We also found that patients who smoke get recurrent disease due to scarring.

At both UC Davis and Johns Hopkins, we created a YouTube video for patients to educate them on the procedure and expected results. The need for postoperative physical therapy should be emphasized in all patients. Some require more therapy than others, which means taking time off from work to focus on the therapy and not performing other activities until the pain and discomfort are gone and strength is back. In another study we performed, we found that if patients did improve the first year, they were more likely to stay symptom free over many years.

While we were doing a transaxillary rib resection case at UC Davis, my team, which includes my partner Misty Humphries, MD, created a list of the top 10 reasons that the transaxillary approach is preferred for neurogenic thoracic outlet syndrome:

 

 

1. The scar is less noticeable and painful for the patient than the scar in the supraclavicular fossa, allowing the patient to start physical therapy 2 weeks after surgery.

2. The Machleder retractor makes visualization easy and stable, and allows all members of the team to see the anatomy.

3. The brachial plexus does not have to be retracted and is out of harm’s way, so no temporary palsies are seen in the postoperative period.

4. The subclavius tendon can be seen in entirety and the anterior portion of the rib is easy to completely remove.

5. The subclavian vein can be seen in entirety and defines the anterior portion of the dissection.

6. Once the anterior scalenectomy muscle is cut, the subclavian artery naturally retracts cephalad and is no longer near the rib when it is to be removed.

7. The posterior portion of the rib can be completely removed by readjusting the retraction and a second cut can be done safely with either the rib cutter or the first rib rongeur. It is essential to remove the rib posteriorly behind the nerve root so the arm is adducted and the nerve does not come in contact with the remaining rib, as we feel that leads to increased recurrences.

8. Two operating surgeons can address the rib from their side of the table and completely resect the rib, depending on the patient’s soft bony anatomy, by angling the instruments from either side.

9. Even large muscular or obese patients can be safely approached from the axilla utilizing the Machleder retractor and a lighted retractor.

10. The transaxillary approach can be taught through the teaching video we have made and through the ability for both surgeons to see because of the retractor.

Some of my favorite memories as a vascular surgeon were operating on Tuesdays with Dr. Machleder – similar to Tuesdays with Morrie.4 Not only did we remove ribs safely and completely, but he also taught me philosophy of surgery and of life. I hope I am doing the same with my team as we remove ribs now on Thursday – “Thursdays with Freischlag” – at UC Davis.

Dr. Freischlag is vice chancellor for human health sciences and dean of the school of medicine at the University of California, Davis. She had no relevant disclosures.

References

1. J Vasc Surg. 2012;55(5):1370-5.

2. Curr Treat Options Cardiovasc Med. 2009;11(2):176-83.

3. J Vasc Surg. 2012;56(4):1061-7.

4. Albom M. Tuesdays with Morrie: An old man, a young man, and life’s greatest lesson. New York: Doubleday; 1997.

Use a supraclavicular approach: My way is best!

The best sense we have of the pathophysiology of neurogenic (NTOS) is that the scalene triangle is “too tight” with regard to what it contains – the brachial plexus and the subclavian artery. Whether this is due to the triangle being too small or the nerves being “too large” (inflammation) is unknown. Supporting the former theory are observations that the anterior scalene muscle is frequently inflamed and/or chronically injured.1 but others have suggested that the first rib is abnormally located or elevated.2 In addition, some have suggested that inflammatory tissue surrounding the plexus contributes to the process, at least for chronic cases.3

Given the fact that at least two of the three parts of the triangle, plus tissue surrounding the plexus itself, have all been implicated in the disease process, why not choose an approach that allows correction of all potential causes? The transaxillary approach has been used for decades for this condition, but can only decompress the base of the triangle (first rib) and, to varying degrees, only part of the anterior scalene. It does not allow thorough exploration of the nerves. The supraclavicular approach (and the supraclavicular half of paraclavicular excision) addresses these concerns. First, the anterior scalene muscle is essentially entirely removed. With proper technique it is completely visible from the scalene tubercle to its origin at the spine. This approach also allows removal of all muscular and associated tissue medially, completely clearing the parietal pleura at the apex of the lung, at least theoretically reducing the chances of scar tissue arising from residual tissue here.

Dr. Karl A. Illig

Second, although no research has yet implicated the middle scalene (scalenus medius, which does not translate perfectly), many patients have impressively bulky musculature at this site. The middle scalene is also completely resected while approaching the first rib; perhaps removing this as well contributes to the excellent results we see today.

Third, the entire portion of the rib involved in NTOS (and the entire rib altogether if a paraclavicular approach is used) is very easily removed using this approach, as are any cervical ribs or Roos bands. Everything is seen, and everything can be evaluated and resected. Finally, many consider full neurolysis of the brachial plexus in this area an important part of the procedure. This is based on low-grade evidence only,3 but in the author’s experience, the incidence of improvement or cure seems to be higher, and recurrence rates lower, than with less-complete operations.

 

 

Parenthetically, related to this issue is that of visualization and education. The primary goal is ensuring the best outcome for the patient. Visualization is, by far, best if a supraclavicular approach is used. This is beneficial clinically by ensuring the most complete decompression of the nerves and avoidance of complications, but also is extremely helpful with regard to educating residents and fellows, learning the anatomy, identifying aberrant structures, and so on. Even with the best techniques (including a head- or retractor-mounted camera), no one can see what’s going on during a transaxillary approach except for the operator.

If the supraclavicular approach allows better access to and removal of all the potentially involved components causing NTOS, why doesn’t everyone use it? One answer is that the potential complication rate may be higher. Both the long thoracic and phrenic nerves are very much more at risk using this approach than using the transaxillary approach, and, on the left side, the risk of thoracic duct injury is higher. It must be conceded that published results, in general, do not show significant differences in outcomes between the two approaches.4 However, many would interpret this as a type II error, combined with the “fuzziness” of diagnosis and evaluation of outcomes this field has labored under. However, the opposite interpretation should be considered – there are no definitive data showing any higher complication rate between the two approaches. This debate likely is answerable in the same fashion as many other such debates in our field – someone who is good at the transaxillary approach will do a better job than someone who is not, and someone who is good at the supraclavicular approach will do a better job than someone who is not.

Is a prospective trial indicated? In theory, yes. However, the relative rarity of this condition, the fact that most surgeons follow almost exclusively one or the other technique, and the categorical nature of the outcome variable make such a trial relatively impractical. Pending this, the best suggestion is obviously to pick the best TOS surgeon you can find and have him or her fix the problem in the way they are most experienced!

Dr. Illig is professor of surgery and director, division of vascular surgery, and associate chair, faculty development and mentoring, University of South Florida, Morsani College of Medicine, Tampa, Fla. He had no relevant disclosures.

References

1. Arch Surg 1986;121:1141-4.

2. Thoracic Outlet Syndrome. London: Springer 2013; 319-21.

3. Vasc Endovasc Surg 2003;37:253-7.

4. Thoracic Outlet Syndrome. London: Springer 2013; 315-7.

References

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The transaxillary approach has its advantages

I began my vascular fellowship at UCLA on July 1, 1986 – the previous day I was a chief surgery resident running a VA general surgery service where my last emergency case that evening was an abdominal peroneal resection for perforated rectal cancer! I was delighted to begin my fellowship, and learned that on Tuesdays I would be operating with Herb Machleder, MD – the expert on thoracic outlet syndrome (TOS) who perfected the transaxillary approach. I remembered his service from when I was an intern holding the patient arm up by cradling it my arms while he and the fellow removed the rib and identified each structure—subclavius tendon, subclavian vein, anterior scalene muscle, subclavian artery brachial plexus and any other abnormal band or structure present. The rib was removed in entirety to ensure an excellent outcome and to prevent any possibility of recurrence from scarring to the brachial plexus to a portion of retained rib. Dr. Machleder then went on to design a rib retractor to better support the arm and afford superb visibility.

As I began my career, I included transaxillary first rib resection as part of my practice for all forms of TOS, except when we needed to replace the subclavian artery because of an aneurysm or thrombosis. In those instances, we would employ the supraclavicular approach with an infraclavicular incision when necessary. In my 5 years as chief of the division of vascular surgery at UCLA (1998-2003), we saw many patients with TOS thanks to the legacy and practice of Dr. Machleder. We performed approximately 300 such operations between three of us and saw probably three to four times as many patients in clinic who did not need surgery to treat their TOS or other conditions.

Dr. Julie A. Freischlag

When I arrived at Johns Hopkins as department chair in 2003, a robust thoracic outlet program did not exist there, so we began one. By the time I left in 2014, we were seeing 5-7 new patients per week and were operating on 125 per year, of which half were neurogenic. Ying Wei Lum, MD, and Maggie Arnold, MD, are continuing that practice at Johns Hopkins today.

The most important point about the “approach” for neurogenic thoracic outlet syndrome is whether or not you should operate. At Johns Hopkins, we only operated on about a third of those who presented to us with neurogenic symptoms, as 60%-70% will get better with a thoracic outlet–focused physical therapy regimen. We developed a protocol for this, which we actually handed to the patients as the prescription as they came from all over for our opinion on their conditions. We are doing the same at UC Davis.

We have published a great deal about patients who do not do as well with the surgical approach to neurogenic TOS. These patients include those over the age of 40 and those who have had symptoms for more than 10 years, as they tend to be quite debilitated and never quite recover fully from the operation.1 A scalene block with lidocaine can predict success in patients with the operation, and I use it in older patients or those with multiple complaints.2 At UC Davis, our pain service can perform the block with ultrasound guidance, which is easier for the patient.

Other patients who do not do well with the surgical approach to neurogenic TOS include those with other comorbidities such as cervical spine disease and shoulder abnormalities or injuries, as well as those with a severe dependence on pain medication due to such medical issues as complex pain syndrome or myofasciitis caused by comorbid diseases.3

These patients cannot adequately perform the requisite postoperative physical therapy to completely improve, and some can take up to a year to get range of motion and strength back. We also found that patients who smoke get recurrent disease due to scarring.

At both UC Davis and Johns Hopkins, we created a YouTube video for patients to educate them on the procedure and expected results. The need for postoperative physical therapy should be emphasized in all patients. Some require more therapy than others, which means taking time off from work to focus on the therapy and not performing other activities until the pain and discomfort are gone and strength is back. In another study we performed, we found that if patients did improve the first year, they were more likely to stay symptom free over many years.

While we were doing a transaxillary rib resection case at UC Davis, my team, which includes my partner Misty Humphries, MD, created a list of the top 10 reasons that the transaxillary approach is preferred for neurogenic thoracic outlet syndrome:

 

 

1. The scar is less noticeable and painful for the patient than the scar in the supraclavicular fossa, allowing the patient to start physical therapy 2 weeks after surgery.

2. The Machleder retractor makes visualization easy and stable, and allows all members of the team to see the anatomy.

3. The brachial plexus does not have to be retracted and is out of harm’s way, so no temporary palsies are seen in the postoperative period.

4. The subclavius tendon can be seen in entirety and the anterior portion of the rib is easy to completely remove.

5. The subclavian vein can be seen in entirety and defines the anterior portion of the dissection.

6. Once the anterior scalenectomy muscle is cut, the subclavian artery naturally retracts cephalad and is no longer near the rib when it is to be removed.

7. The posterior portion of the rib can be completely removed by readjusting the retraction and a second cut can be done safely with either the rib cutter or the first rib rongeur. It is essential to remove the rib posteriorly behind the nerve root so the arm is adducted and the nerve does not come in contact with the remaining rib, as we feel that leads to increased recurrences.

8. Two operating surgeons can address the rib from their side of the table and completely resect the rib, depending on the patient’s soft bony anatomy, by angling the instruments from either side.

9. Even large muscular or obese patients can be safely approached from the axilla utilizing the Machleder retractor and a lighted retractor.

10. The transaxillary approach can be taught through the teaching video we have made and through the ability for both surgeons to see because of the retractor.

Some of my favorite memories as a vascular surgeon were operating on Tuesdays with Dr. Machleder – similar to Tuesdays with Morrie.4 Not only did we remove ribs safely and completely, but he also taught me philosophy of surgery and of life. I hope I am doing the same with my team as we remove ribs now on Thursday – “Thursdays with Freischlag” – at UC Davis.

Dr. Freischlag is vice chancellor for human health sciences and dean of the school of medicine at the University of California, Davis. She had no relevant disclosures.

References

1. J Vasc Surg. 2012;55(5):1370-5.

2. Curr Treat Options Cardiovasc Med. 2009;11(2):176-83.

3. J Vasc Surg. 2012;56(4):1061-7.

4. Albom M. Tuesdays with Morrie: An old man, a young man, and life’s greatest lesson. New York: Doubleday; 1997.

Use a supraclavicular approach: My way is best!

The best sense we have of the pathophysiology of neurogenic (NTOS) is that the scalene triangle is “too tight” with regard to what it contains – the brachial plexus and the subclavian artery. Whether this is due to the triangle being too small or the nerves being “too large” (inflammation) is unknown. Supporting the former theory are observations that the anterior scalene muscle is frequently inflamed and/or chronically injured.1 but others have suggested that the first rib is abnormally located or elevated.2 In addition, some have suggested that inflammatory tissue surrounding the plexus contributes to the process, at least for chronic cases.3

Given the fact that at least two of the three parts of the triangle, plus tissue surrounding the plexus itself, have all been implicated in the disease process, why not choose an approach that allows correction of all potential causes? The transaxillary approach has been used for decades for this condition, but can only decompress the base of the triangle (first rib) and, to varying degrees, only part of the anterior scalene. It does not allow thorough exploration of the nerves. The supraclavicular approach (and the supraclavicular half of paraclavicular excision) addresses these concerns. First, the anterior scalene muscle is essentially entirely removed. With proper technique it is completely visible from the scalene tubercle to its origin at the spine. This approach also allows removal of all muscular and associated tissue medially, completely clearing the parietal pleura at the apex of the lung, at least theoretically reducing the chances of scar tissue arising from residual tissue here.

Dr. Karl A. Illig

Second, although no research has yet implicated the middle scalene (scalenus medius, which does not translate perfectly), many patients have impressively bulky musculature at this site. The middle scalene is also completely resected while approaching the first rib; perhaps removing this as well contributes to the excellent results we see today.

Third, the entire portion of the rib involved in NTOS (and the entire rib altogether if a paraclavicular approach is used) is very easily removed using this approach, as are any cervical ribs or Roos bands. Everything is seen, and everything can be evaluated and resected. Finally, many consider full neurolysis of the brachial plexus in this area an important part of the procedure. This is based on low-grade evidence only,3 but in the author’s experience, the incidence of improvement or cure seems to be higher, and recurrence rates lower, than with less-complete operations.

 

 

Parenthetically, related to this issue is that of visualization and education. The primary goal is ensuring the best outcome for the patient. Visualization is, by far, best if a supraclavicular approach is used. This is beneficial clinically by ensuring the most complete decompression of the nerves and avoidance of complications, but also is extremely helpful with regard to educating residents and fellows, learning the anatomy, identifying aberrant structures, and so on. Even with the best techniques (including a head- or retractor-mounted camera), no one can see what’s going on during a transaxillary approach except for the operator.

If the supraclavicular approach allows better access to and removal of all the potentially involved components causing NTOS, why doesn’t everyone use it? One answer is that the potential complication rate may be higher. Both the long thoracic and phrenic nerves are very much more at risk using this approach than using the transaxillary approach, and, on the left side, the risk of thoracic duct injury is higher. It must be conceded that published results, in general, do not show significant differences in outcomes between the two approaches.4 However, many would interpret this as a type II error, combined with the “fuzziness” of diagnosis and evaluation of outcomes this field has labored under. However, the opposite interpretation should be considered – there are no definitive data showing any higher complication rate between the two approaches. This debate likely is answerable in the same fashion as many other such debates in our field – someone who is good at the transaxillary approach will do a better job than someone who is not, and someone who is good at the supraclavicular approach will do a better job than someone who is not.

Is a prospective trial indicated? In theory, yes. However, the relative rarity of this condition, the fact that most surgeons follow almost exclusively one or the other technique, and the categorical nature of the outcome variable make such a trial relatively impractical. Pending this, the best suggestion is obviously to pick the best TOS surgeon you can find and have him or her fix the problem in the way they are most experienced!

Dr. Illig is professor of surgery and director, division of vascular surgery, and associate chair, faculty development and mentoring, University of South Florida, Morsani College of Medicine, Tampa, Fla. He had no relevant disclosures.

References

1. Arch Surg 1986;121:1141-4.

2. Thoracic Outlet Syndrome. London: Springer 2013; 319-21.

3. Vasc Endovasc Surg 2003;37:253-7.

4. Thoracic Outlet Syndrome. London: Springer 2013; 315-7.

The transaxillary approach has its advantages

I began my vascular fellowship at UCLA on July 1, 1986 – the previous day I was a chief surgery resident running a VA general surgery service where my last emergency case that evening was an abdominal peroneal resection for perforated rectal cancer! I was delighted to begin my fellowship, and learned that on Tuesdays I would be operating with Herb Machleder, MD – the expert on thoracic outlet syndrome (TOS) who perfected the transaxillary approach. I remembered his service from when I was an intern holding the patient arm up by cradling it my arms while he and the fellow removed the rib and identified each structure—subclavius tendon, subclavian vein, anterior scalene muscle, subclavian artery brachial plexus and any other abnormal band or structure present. The rib was removed in entirety to ensure an excellent outcome and to prevent any possibility of recurrence from scarring to the brachial plexus to a portion of retained rib. Dr. Machleder then went on to design a rib retractor to better support the arm and afford superb visibility.

As I began my career, I included transaxillary first rib resection as part of my practice for all forms of TOS, except when we needed to replace the subclavian artery because of an aneurysm or thrombosis. In those instances, we would employ the supraclavicular approach with an infraclavicular incision when necessary. In my 5 years as chief of the division of vascular surgery at UCLA (1998-2003), we saw many patients with TOS thanks to the legacy and practice of Dr. Machleder. We performed approximately 300 such operations between three of us and saw probably three to four times as many patients in clinic who did not need surgery to treat their TOS or other conditions.

Dr. Julie A. Freischlag

When I arrived at Johns Hopkins as department chair in 2003, a robust thoracic outlet program did not exist there, so we began one. By the time I left in 2014, we were seeing 5-7 new patients per week and were operating on 125 per year, of which half were neurogenic. Ying Wei Lum, MD, and Maggie Arnold, MD, are continuing that practice at Johns Hopkins today.

The most important point about the “approach” for neurogenic thoracic outlet syndrome is whether or not you should operate. At Johns Hopkins, we only operated on about a third of those who presented to us with neurogenic symptoms, as 60%-70% will get better with a thoracic outlet–focused physical therapy regimen. We developed a protocol for this, which we actually handed to the patients as the prescription as they came from all over for our opinion on their conditions. We are doing the same at UC Davis.

We have published a great deal about patients who do not do as well with the surgical approach to neurogenic TOS. These patients include those over the age of 40 and those who have had symptoms for more than 10 years, as they tend to be quite debilitated and never quite recover fully from the operation.1 A scalene block with lidocaine can predict success in patients with the operation, and I use it in older patients or those with multiple complaints.2 At UC Davis, our pain service can perform the block with ultrasound guidance, which is easier for the patient.

Other patients who do not do well with the surgical approach to neurogenic TOS include those with other comorbidities such as cervical spine disease and shoulder abnormalities or injuries, as well as those with a severe dependence on pain medication due to such medical issues as complex pain syndrome or myofasciitis caused by comorbid diseases.3

These patients cannot adequately perform the requisite postoperative physical therapy to completely improve, and some can take up to a year to get range of motion and strength back. We also found that patients who smoke get recurrent disease due to scarring.

At both UC Davis and Johns Hopkins, we created a YouTube video for patients to educate them on the procedure and expected results. The need for postoperative physical therapy should be emphasized in all patients. Some require more therapy than others, which means taking time off from work to focus on the therapy and not performing other activities until the pain and discomfort are gone and strength is back. In another study we performed, we found that if patients did improve the first year, they were more likely to stay symptom free over many years.

While we were doing a transaxillary rib resection case at UC Davis, my team, which includes my partner Misty Humphries, MD, created a list of the top 10 reasons that the transaxillary approach is preferred for neurogenic thoracic outlet syndrome:

 

 

1. The scar is less noticeable and painful for the patient than the scar in the supraclavicular fossa, allowing the patient to start physical therapy 2 weeks after surgery.

2. The Machleder retractor makes visualization easy and stable, and allows all members of the team to see the anatomy.

3. The brachial plexus does not have to be retracted and is out of harm’s way, so no temporary palsies are seen in the postoperative period.

4. The subclavius tendon can be seen in entirety and the anterior portion of the rib is easy to completely remove.

5. The subclavian vein can be seen in entirety and defines the anterior portion of the dissection.

6. Once the anterior scalenectomy muscle is cut, the subclavian artery naturally retracts cephalad and is no longer near the rib when it is to be removed.

7. The posterior portion of the rib can be completely removed by readjusting the retraction and a second cut can be done safely with either the rib cutter or the first rib rongeur. It is essential to remove the rib posteriorly behind the nerve root so the arm is adducted and the nerve does not come in contact with the remaining rib, as we feel that leads to increased recurrences.

8. Two operating surgeons can address the rib from their side of the table and completely resect the rib, depending on the patient’s soft bony anatomy, by angling the instruments from either side.

9. Even large muscular or obese patients can be safely approached from the axilla utilizing the Machleder retractor and a lighted retractor.

10. The transaxillary approach can be taught through the teaching video we have made and through the ability for both surgeons to see because of the retractor.

Some of my favorite memories as a vascular surgeon were operating on Tuesdays with Dr. Machleder – similar to Tuesdays with Morrie.4 Not only did we remove ribs safely and completely, but he also taught me philosophy of surgery and of life. I hope I am doing the same with my team as we remove ribs now on Thursday – “Thursdays with Freischlag” – at UC Davis.

Dr. Freischlag is vice chancellor for human health sciences and dean of the school of medicine at the University of California, Davis. She had no relevant disclosures.

References

1. J Vasc Surg. 2012;55(5):1370-5.

2. Curr Treat Options Cardiovasc Med. 2009;11(2):176-83.

3. J Vasc Surg. 2012;56(4):1061-7.

4. Albom M. Tuesdays with Morrie: An old man, a young man, and life’s greatest lesson. New York: Doubleday; 1997.

Use a supraclavicular approach: My way is best!

The best sense we have of the pathophysiology of neurogenic (NTOS) is that the scalene triangle is “too tight” with regard to what it contains – the brachial plexus and the subclavian artery. Whether this is due to the triangle being too small or the nerves being “too large” (inflammation) is unknown. Supporting the former theory are observations that the anterior scalene muscle is frequently inflamed and/or chronically injured.1 but others have suggested that the first rib is abnormally located or elevated.2 In addition, some have suggested that inflammatory tissue surrounding the plexus contributes to the process, at least for chronic cases.3

Given the fact that at least two of the three parts of the triangle, plus tissue surrounding the plexus itself, have all been implicated in the disease process, why not choose an approach that allows correction of all potential causes? The transaxillary approach has been used for decades for this condition, but can only decompress the base of the triangle (first rib) and, to varying degrees, only part of the anterior scalene. It does not allow thorough exploration of the nerves. The supraclavicular approach (and the supraclavicular half of paraclavicular excision) addresses these concerns. First, the anterior scalene muscle is essentially entirely removed. With proper technique it is completely visible from the scalene tubercle to its origin at the spine. This approach also allows removal of all muscular and associated tissue medially, completely clearing the parietal pleura at the apex of the lung, at least theoretically reducing the chances of scar tissue arising from residual tissue here.

Dr. Karl A. Illig

Second, although no research has yet implicated the middle scalene (scalenus medius, which does not translate perfectly), many patients have impressively bulky musculature at this site. The middle scalene is also completely resected while approaching the first rib; perhaps removing this as well contributes to the excellent results we see today.

Third, the entire portion of the rib involved in NTOS (and the entire rib altogether if a paraclavicular approach is used) is very easily removed using this approach, as are any cervical ribs or Roos bands. Everything is seen, and everything can be evaluated and resected. Finally, many consider full neurolysis of the brachial plexus in this area an important part of the procedure. This is based on low-grade evidence only,3 but in the author’s experience, the incidence of improvement or cure seems to be higher, and recurrence rates lower, than with less-complete operations.

 

 

Parenthetically, related to this issue is that of visualization and education. The primary goal is ensuring the best outcome for the patient. Visualization is, by far, best if a supraclavicular approach is used. This is beneficial clinically by ensuring the most complete decompression of the nerves and avoidance of complications, but also is extremely helpful with regard to educating residents and fellows, learning the anatomy, identifying aberrant structures, and so on. Even with the best techniques (including a head- or retractor-mounted camera), no one can see what’s going on during a transaxillary approach except for the operator.

If the supraclavicular approach allows better access to and removal of all the potentially involved components causing NTOS, why doesn’t everyone use it? One answer is that the potential complication rate may be higher. Both the long thoracic and phrenic nerves are very much more at risk using this approach than using the transaxillary approach, and, on the left side, the risk of thoracic duct injury is higher. It must be conceded that published results, in general, do not show significant differences in outcomes between the two approaches.4 However, many would interpret this as a type II error, combined with the “fuzziness” of diagnosis and evaluation of outcomes this field has labored under. However, the opposite interpretation should be considered – there are no definitive data showing any higher complication rate between the two approaches. This debate likely is answerable in the same fashion as many other such debates in our field – someone who is good at the transaxillary approach will do a better job than someone who is not, and someone who is good at the supraclavicular approach will do a better job than someone who is not.

Is a prospective trial indicated? In theory, yes. However, the relative rarity of this condition, the fact that most surgeons follow almost exclusively one or the other technique, and the categorical nature of the outcome variable make such a trial relatively impractical. Pending this, the best suggestion is obviously to pick the best TOS surgeon you can find and have him or her fix the problem in the way they are most experienced!

Dr. Illig is professor of surgery and director, division of vascular surgery, and associate chair, faculty development and mentoring, University of South Florida, Morsani College of Medicine, Tampa, Fla. He had no relevant disclosures.

References

1. Arch Surg 1986;121:1141-4.

2. Thoracic Outlet Syndrome. London: Springer 2013; 319-21.

3. Vasc Endovasc Surg 2003;37:253-7.

4. Thoracic Outlet Syndrome. London: Springer 2013; 315-7.

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AAN recommends against routine closure of patent foramen ovale for secondary stroke prevention

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AAN recommends against routine closure of patent foramen ovale for secondary stroke prevention

An updated practice advisory from the American Academy of Neurology does not recommend the routine use of catheter-based closure of patent foramen ovale in patients with a history of cryptogenic ischemic stroke.

“Because of the limitations of the efficacy evidence and the potential for serious adverse effects, we judge the risk-benefit trade-offs of PFO [patent foramen ovale] closure by either the STARFlex or AMPLATZER PFO Occluder to be uncertain,” wrote Steven Messé, MD, associate professor of neurology at the University of Pennsylvania, Philadelphia, and his associates. “In rare circumstances, such as recurrent strokes despite adequate medical therapy with no other mechanism identified, clinicians may offer the AMPLATZER PFO Occluder if it is available,” they noted.

Ridofranz/Thinkstock

They also supported antiplatelet agents over anticoagulants unless patients have another indication for blood thinners, noting “the uncertainty surrounding the benefit of anticoagulation in the setting of PFO, and anticoagulation’s well-known harm profile.”

PFO affects about one in four individuals overall and up to half of cryptogenic stroke patients. The previous (2004) version of this practice advisory cited insufficient evidence to guide optimal therapy for secondary stroke prevention in these patients (Neurology. 2004;Apr 13;62[7]:1042-50). To update the guideline, Dr. Messé and his associates searched the literature for relevant randomized studies, excluding transient ischemic attacks when feasible because of their subjective nature, and focusing on intention-to-treat analyses to reduce bias (Neurology. 2016 Jul 27;doi: 10.1212/WNL.0000000000002961).

Among 809 initial articles, 5 were considered relevant – a randomized, open-label, multicenter study of the STARFlex device (CLOSURE I), two randomized, controlled trials of the AMPLATZER PFO Occluder (PC Trial and RESPECT), and two randomized studies of warfarin versus aspirin in cryptogenic stroke patients, the experts said.

Percutaneous PFO closure with the STARFlex device did not appear to prevent secondary stroke, compared with medical therapy alone, based on a small positive estimated difference in risk of about 0.1%, and a 95% confidence interval that crossed zero (–2.2% to 2.0%). In contrast, the AMPLATZER PFO Occluder decreased the risk of secondary stroke by about 1.7% (95% CI, –3.2% to –0.2%), but upped the risk of procedural complications by more than 3%, and also slightly increased the risk of new-onset atrial fibrillation (1.6%; 95% CI, 0.1% to 3.2%).

Efficacy data were insufficient to clearly support anticoagulants over antiplatelet therapy for recurrent stroke prevention, the experts concluded. Compared with antiplatelet therapy, anticoagulation was associated with a 2% increase in risk of recurrent stroke, but the 95% confidence interval for this estimate was wide and crossed zero. “In the absence of another indication for anticoagulation, clinicians may routinely offer antiplatelet medications instead of anticoagulation to patients with cryptogenic stroke and PFO,” they wrote. “In rare circumstances, such as stroke that recurs while a patient is undergoing antiplatelet therapy, clinicians may offer anticoagulation to patients with cryptogenic stroke and PFO.”

Their strongest recommendation was to counsel patients who are considering percutaneous PFO closure “that having a PFO is common; it occurs in about 1 in 4 people; it is impossible to determine with certainty whether their PFOs caused their strokes or TIAs; the effectiveness of the procedure for reducing stroke risk remains uncertain; and the procedure is associated with relatively uncommon, yet potentially serious, complications.”

The practice advisory was supported by the American Academy of Neurology. Dr. Messé disclosed ties to GlaxoSmithKline and WL Gore & Associates and has been an investigator for the REDUCE and CLOSURE-I trials. Five of his coauthors have been investigators for RESPECT, CLOSURE-I, and REDUCE, have been editors for Neurology, and have received compensation from Genentech, Pfizer, Gilead Sciences, and other pharmaceutical companies. One coauthor had no disclosures.

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An updated practice advisory from the American Academy of Neurology does not recommend the routine use of catheter-based closure of patent foramen ovale in patients with a history of cryptogenic ischemic stroke.

“Because of the limitations of the efficacy evidence and the potential for serious adverse effects, we judge the risk-benefit trade-offs of PFO [patent foramen ovale] closure by either the STARFlex or AMPLATZER PFO Occluder to be uncertain,” wrote Steven Messé, MD, associate professor of neurology at the University of Pennsylvania, Philadelphia, and his associates. “In rare circumstances, such as recurrent strokes despite adequate medical therapy with no other mechanism identified, clinicians may offer the AMPLATZER PFO Occluder if it is available,” they noted.

Ridofranz/Thinkstock

They also supported antiplatelet agents over anticoagulants unless patients have another indication for blood thinners, noting “the uncertainty surrounding the benefit of anticoagulation in the setting of PFO, and anticoagulation’s well-known harm profile.”

PFO affects about one in four individuals overall and up to half of cryptogenic stroke patients. The previous (2004) version of this practice advisory cited insufficient evidence to guide optimal therapy for secondary stroke prevention in these patients (Neurology. 2004;Apr 13;62[7]:1042-50). To update the guideline, Dr. Messé and his associates searched the literature for relevant randomized studies, excluding transient ischemic attacks when feasible because of their subjective nature, and focusing on intention-to-treat analyses to reduce bias (Neurology. 2016 Jul 27;doi: 10.1212/WNL.0000000000002961).

Among 809 initial articles, 5 were considered relevant – a randomized, open-label, multicenter study of the STARFlex device (CLOSURE I), two randomized, controlled trials of the AMPLATZER PFO Occluder (PC Trial and RESPECT), and two randomized studies of warfarin versus aspirin in cryptogenic stroke patients, the experts said.

Percutaneous PFO closure with the STARFlex device did not appear to prevent secondary stroke, compared with medical therapy alone, based on a small positive estimated difference in risk of about 0.1%, and a 95% confidence interval that crossed zero (–2.2% to 2.0%). In contrast, the AMPLATZER PFO Occluder decreased the risk of secondary stroke by about 1.7% (95% CI, –3.2% to –0.2%), but upped the risk of procedural complications by more than 3%, and also slightly increased the risk of new-onset atrial fibrillation (1.6%; 95% CI, 0.1% to 3.2%).

Efficacy data were insufficient to clearly support anticoagulants over antiplatelet therapy for recurrent stroke prevention, the experts concluded. Compared with antiplatelet therapy, anticoagulation was associated with a 2% increase in risk of recurrent stroke, but the 95% confidence interval for this estimate was wide and crossed zero. “In the absence of another indication for anticoagulation, clinicians may routinely offer antiplatelet medications instead of anticoagulation to patients with cryptogenic stroke and PFO,” they wrote. “In rare circumstances, such as stroke that recurs while a patient is undergoing antiplatelet therapy, clinicians may offer anticoagulation to patients with cryptogenic stroke and PFO.”

Their strongest recommendation was to counsel patients who are considering percutaneous PFO closure “that having a PFO is common; it occurs in about 1 in 4 people; it is impossible to determine with certainty whether their PFOs caused their strokes or TIAs; the effectiveness of the procedure for reducing stroke risk remains uncertain; and the procedure is associated with relatively uncommon, yet potentially serious, complications.”

The practice advisory was supported by the American Academy of Neurology. Dr. Messé disclosed ties to GlaxoSmithKline and WL Gore & Associates and has been an investigator for the REDUCE and CLOSURE-I trials. Five of his coauthors have been investigators for RESPECT, CLOSURE-I, and REDUCE, have been editors for Neurology, and have received compensation from Genentech, Pfizer, Gilead Sciences, and other pharmaceutical companies. One coauthor had no disclosures.

An updated practice advisory from the American Academy of Neurology does not recommend the routine use of catheter-based closure of patent foramen ovale in patients with a history of cryptogenic ischemic stroke.

“Because of the limitations of the efficacy evidence and the potential for serious adverse effects, we judge the risk-benefit trade-offs of PFO [patent foramen ovale] closure by either the STARFlex or AMPLATZER PFO Occluder to be uncertain,” wrote Steven Messé, MD, associate professor of neurology at the University of Pennsylvania, Philadelphia, and his associates. “In rare circumstances, such as recurrent strokes despite adequate medical therapy with no other mechanism identified, clinicians may offer the AMPLATZER PFO Occluder if it is available,” they noted.

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They also supported antiplatelet agents over anticoagulants unless patients have another indication for blood thinners, noting “the uncertainty surrounding the benefit of anticoagulation in the setting of PFO, and anticoagulation’s well-known harm profile.”

PFO affects about one in four individuals overall and up to half of cryptogenic stroke patients. The previous (2004) version of this practice advisory cited insufficient evidence to guide optimal therapy for secondary stroke prevention in these patients (Neurology. 2004;Apr 13;62[7]:1042-50). To update the guideline, Dr. Messé and his associates searched the literature for relevant randomized studies, excluding transient ischemic attacks when feasible because of their subjective nature, and focusing on intention-to-treat analyses to reduce bias (Neurology. 2016 Jul 27;doi: 10.1212/WNL.0000000000002961).

Among 809 initial articles, 5 were considered relevant – a randomized, open-label, multicenter study of the STARFlex device (CLOSURE I), two randomized, controlled trials of the AMPLATZER PFO Occluder (PC Trial and RESPECT), and two randomized studies of warfarin versus aspirin in cryptogenic stroke patients, the experts said.

Percutaneous PFO closure with the STARFlex device did not appear to prevent secondary stroke, compared with medical therapy alone, based on a small positive estimated difference in risk of about 0.1%, and a 95% confidence interval that crossed zero (–2.2% to 2.0%). In contrast, the AMPLATZER PFO Occluder decreased the risk of secondary stroke by about 1.7% (95% CI, –3.2% to –0.2%), but upped the risk of procedural complications by more than 3%, and also slightly increased the risk of new-onset atrial fibrillation (1.6%; 95% CI, 0.1% to 3.2%).

Efficacy data were insufficient to clearly support anticoagulants over antiplatelet therapy for recurrent stroke prevention, the experts concluded. Compared with antiplatelet therapy, anticoagulation was associated with a 2% increase in risk of recurrent stroke, but the 95% confidence interval for this estimate was wide and crossed zero. “In the absence of another indication for anticoagulation, clinicians may routinely offer antiplatelet medications instead of anticoagulation to patients with cryptogenic stroke and PFO,” they wrote. “In rare circumstances, such as stroke that recurs while a patient is undergoing antiplatelet therapy, clinicians may offer anticoagulation to patients with cryptogenic stroke and PFO.”

Their strongest recommendation was to counsel patients who are considering percutaneous PFO closure “that having a PFO is common; it occurs in about 1 in 4 people; it is impossible to determine with certainty whether their PFOs caused their strokes or TIAs; the effectiveness of the procedure for reducing stroke risk remains uncertain; and the procedure is associated with relatively uncommon, yet potentially serious, complications.”

The practice advisory was supported by the American Academy of Neurology. Dr. Messé disclosed ties to GlaxoSmithKline and WL Gore & Associates and has been an investigator for the REDUCE and CLOSURE-I trials. Five of his coauthors have been investigators for RESPECT, CLOSURE-I, and REDUCE, have been editors for Neurology, and have received compensation from Genentech, Pfizer, Gilead Sciences, and other pharmaceutical companies. One coauthor had no disclosures.

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Clinical value of costly ER/PR testing of ductal carcinoma biopsies questioned

Hormone testing for DCIS still needed
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Limiting hormone receptor testing of diagnostic core biopisies containing ductal carcinoma in situ (DCIS) could save up to $35 million in associated health care costs every year in the United States.

The results of a cost analysis conducted by researchers at Johns Hopkins University were so striking that the hospital has now eliminated reflex testing of core needle biopsies for DCIS, Christopher J. VandenBussche, MD, and his colleagues wrote in the American Journal of Surgical Pathology (2016;40:1090-9).

“We suggest that reflex [hormone receptor] testing of core needle biopsy specimens harboring DCIS should not be performed, as the results do not guide the next step in therapy,” wrote Dr. VandenBussche of Johns Hopkins University, Baltimore. “On the basis of this study, we have convinced our clinicians and no longer reflexively perform estrogen- and progesterone-receptor [ER/PR] testing on core needle biopsy specimens with DCIS at Hopkins and encourage other institutions to follow suit.”

Conducting expensive hormone receptor testing of these biopsy samples before surgery doesn’t make clinical or financial sense, for several reasons, the team said:

• Hormone receptor status at biopsy has no effect on the next treatment step, as DCIS patients always progress first to surgical excision, not neoadjuvant hormone therapy.

• Surgery sometimes reveals extensive breast cancer in patents with pure DCIS, and these cancers will always need ER/PR testing, rendering irrelevant biopsy testing.

• Because ER and PR labeling are often heterogeneous in DCIS, negative results for ER/PR on small core needle biopsy specimens would have to be repeated anyway on surgical excision specimens with larger amounts of DCIS, to be sure that the result is truly negative.

• Hormone therapy for DCIS does decrease recurrence, but it doesn’t impact survival – and it does carry significant adverse effects. Therefore, many women refuse hormone therapy if they do have ER/PR-positive tumors.

• The independent role of PR status in DCIS is unproven, so testing for it is not supported by clinical evidence.

To examine the costs associated with reflexive ER/PR testing, the investigators reviewed 58 core needle biopsies of pure DCIS followed by surgical excision. None of the patients had neoadjuvant hormone therapy. Of the 58 tumors, 76% were pure DCIS, and 16% were DCIS with invasive breast cancer. Most of the DCIS (47) tumors were ER+/PR+; 6 were ER-/PR-; and 5 were ER+/PR-.

The team reviewed the records of 49 patients who underwent surgical excision and ended up with a diagnosis of pure DCIS. These included 46 ER-positive cases, and 3 that were ER-negative in both biopsy and excision.

The findings suggested that ER/PR results from either the biopsy and the surgical excision samples were relevant to therapy in only a portion of these patients.

“We found that the ER/PR results after surgical excision impacted therapy in at most only 16 of 49 cases (33%),” they said. These included the 3 ER-/PR-negative cases, which would, in any case, not have triggered hormone therapy; 10 patients who chose hormone therapy despite a Hopkins oncologist’s neutral recommendation; 1 of 2 who took hormone therapy on a Hopkins oncologist’s recommendation; and 2 of 3 who took it after seeing a non-Hopkins oncologist.

“In contrast,” the authors wrote, “in 33 of the cases (67%), the ER/PR result of the DCIS after surgical excision did not impact therapy.” All of these were ER-positive cases, including 4 patients who opted for bilateral mastectomies (no subsequent role for neoadjuvant therapy), 8 who declined to meet with an oncologist, 1 for whom hormone therapy was contraindicated, 8 (of 8) who declined hormone therapy when their Hopkins oncologist did not recommend it, 10 (of 20) who declined hormone therapy when their Hopkins oncologist was neutral about its risk/benefit ratio, 1 (of 2) who declined hormone therapy when the Hopkins oncologist recommended it, and the 1 patient (of 3) who declined hormone therapy after visiting a non-Hopkins oncologist.

After reviewing the costs associated with these cases, “we found that ER testing … costing $20,685.72 ($357 per patient) had been performed unnecessarily,” the investigators said. In addition, if the PR testing – which has never been proven clinically important in DCIS – had been eliminated, there would have been an additional $86.46 savings per patient, a total savings of $5,014.

“Extrapolating the increased cost of $583 per DCIS diagnosis on core needle biopsy to 60,000 new cases of DCIS in the United States each year, reflex core needle biopsy ER/PR testing unnecessarily increases costs by approximately $35 million,” the authors said. “We recommend that ER/PR not be reflexively ordered on core needle biopsy specimens or surgical excision specimens containing DCIS, but instead that ER alone be performed on surgical excision specimens only when hormone therapy is a serious consideration after medical oncology consultation.”

 

 

The group noted that this total reflects the total amount billed, not typical reimbursement. “Regardless,” they said, “the cost of this testing is staggering.”

The authors did not mention the study’s funding source. They had no relevant financial disclosures.

[email protected]

On Twitter @Alz_Gal

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It is important to note that the authors are not recommending hormone receptor testing be completely abandoned for ductal carcinoma in situ. They are simply suggesting that the testing should be deferred to being performed on the surgical resection specimen rather than the diagnostic core needle biopsy tissue.

The sample size used (58 cases) is clearly extremely small and cannot be used as the basis for sweeping recommendations for the many thousands of DCIS cases that are diagnosed in the United States annually. This study is from a major academic program; other programs may run the risk of patients not having the ER testing done at all if it is no longer a routine component of pathology testing on DCIS tissue.

The case is probably stronger for abandoning PR testing in DCIS, since this value is very unlikely to influence management decisions on its own.

Dr. Lisa Newman

Other institutions should be encouraged to perform their own analyses to monitor the cost-effectiveness of ER/PR testing on core needle biopsies revealing DCIS. A study of this type should also be considered for large, multisite data sets, such as the American College of Surgeons’ National Cancer Database.

Lisa Newman, MD, FACS, is director of the breast oncology program for the Henry Ford Health System, and medical director for the Henry Ford International Center for the Study of Breast Cancer Subtypes, both in Detroit. She also serves as adjunct professor of health management and policy at the University of Michigan School of Public Health, Detroit. She has no relevant financial disclosures.

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Body

It is important to note that the authors are not recommending hormone receptor testing be completely abandoned for ductal carcinoma in situ. They are simply suggesting that the testing should be deferred to being performed on the surgical resection specimen rather than the diagnostic core needle biopsy tissue.

The sample size used (58 cases) is clearly extremely small and cannot be used as the basis for sweeping recommendations for the many thousands of DCIS cases that are diagnosed in the United States annually. This study is from a major academic program; other programs may run the risk of patients not having the ER testing done at all if it is no longer a routine component of pathology testing on DCIS tissue.

The case is probably stronger for abandoning PR testing in DCIS, since this value is very unlikely to influence management decisions on its own.

Dr. Lisa Newman

Other institutions should be encouraged to perform their own analyses to monitor the cost-effectiveness of ER/PR testing on core needle biopsies revealing DCIS. A study of this type should also be considered for large, multisite data sets, such as the American College of Surgeons’ National Cancer Database.

Lisa Newman, MD, FACS, is director of the breast oncology program for the Henry Ford Health System, and medical director for the Henry Ford International Center for the Study of Breast Cancer Subtypes, both in Detroit. She also serves as adjunct professor of health management and policy at the University of Michigan School of Public Health, Detroit. She has no relevant financial disclosures.

Body

It is important to note that the authors are not recommending hormone receptor testing be completely abandoned for ductal carcinoma in situ. They are simply suggesting that the testing should be deferred to being performed on the surgical resection specimen rather than the diagnostic core needle biopsy tissue.

The sample size used (58 cases) is clearly extremely small and cannot be used as the basis for sweeping recommendations for the many thousands of DCIS cases that are diagnosed in the United States annually. This study is from a major academic program; other programs may run the risk of patients not having the ER testing done at all if it is no longer a routine component of pathology testing on DCIS tissue.

The case is probably stronger for abandoning PR testing in DCIS, since this value is very unlikely to influence management decisions on its own.

Dr. Lisa Newman

Other institutions should be encouraged to perform their own analyses to monitor the cost-effectiveness of ER/PR testing on core needle biopsies revealing DCIS. A study of this type should also be considered for large, multisite data sets, such as the American College of Surgeons’ National Cancer Database.

Lisa Newman, MD, FACS, is director of the breast oncology program for the Henry Ford Health System, and medical director for the Henry Ford International Center for the Study of Breast Cancer Subtypes, both in Detroit. She also serves as adjunct professor of health management and policy at the University of Michigan School of Public Health, Detroit. She has no relevant financial disclosures.

Title
Hormone testing for DCIS still needed
Hormone testing for DCIS still needed

Limiting hormone receptor testing of diagnostic core biopisies containing ductal carcinoma in situ (DCIS) could save up to $35 million in associated health care costs every year in the United States.

The results of a cost analysis conducted by researchers at Johns Hopkins University were so striking that the hospital has now eliminated reflex testing of core needle biopsies for DCIS, Christopher J. VandenBussche, MD, and his colleagues wrote in the American Journal of Surgical Pathology (2016;40:1090-9).

“We suggest that reflex [hormone receptor] testing of core needle biopsy specimens harboring DCIS should not be performed, as the results do not guide the next step in therapy,” wrote Dr. VandenBussche of Johns Hopkins University, Baltimore. “On the basis of this study, we have convinced our clinicians and no longer reflexively perform estrogen- and progesterone-receptor [ER/PR] testing on core needle biopsy specimens with DCIS at Hopkins and encourage other institutions to follow suit.”

Conducting expensive hormone receptor testing of these biopsy samples before surgery doesn’t make clinical or financial sense, for several reasons, the team said:

• Hormone receptor status at biopsy has no effect on the next treatment step, as DCIS patients always progress first to surgical excision, not neoadjuvant hormone therapy.

• Surgery sometimes reveals extensive breast cancer in patents with pure DCIS, and these cancers will always need ER/PR testing, rendering irrelevant biopsy testing.

• Because ER and PR labeling are often heterogeneous in DCIS, negative results for ER/PR on small core needle biopsy specimens would have to be repeated anyway on surgical excision specimens with larger amounts of DCIS, to be sure that the result is truly negative.

• Hormone therapy for DCIS does decrease recurrence, but it doesn’t impact survival – and it does carry significant adverse effects. Therefore, many women refuse hormone therapy if they do have ER/PR-positive tumors.

• The independent role of PR status in DCIS is unproven, so testing for it is not supported by clinical evidence.

To examine the costs associated with reflexive ER/PR testing, the investigators reviewed 58 core needle biopsies of pure DCIS followed by surgical excision. None of the patients had neoadjuvant hormone therapy. Of the 58 tumors, 76% were pure DCIS, and 16% were DCIS with invasive breast cancer. Most of the DCIS (47) tumors were ER+/PR+; 6 were ER-/PR-; and 5 were ER+/PR-.

The team reviewed the records of 49 patients who underwent surgical excision and ended up with a diagnosis of pure DCIS. These included 46 ER-positive cases, and 3 that were ER-negative in both biopsy and excision.

The findings suggested that ER/PR results from either the biopsy and the surgical excision samples were relevant to therapy in only a portion of these patients.

“We found that the ER/PR results after surgical excision impacted therapy in at most only 16 of 49 cases (33%),” they said. These included the 3 ER-/PR-negative cases, which would, in any case, not have triggered hormone therapy; 10 patients who chose hormone therapy despite a Hopkins oncologist’s neutral recommendation; 1 of 2 who took hormone therapy on a Hopkins oncologist’s recommendation; and 2 of 3 who took it after seeing a non-Hopkins oncologist.

“In contrast,” the authors wrote, “in 33 of the cases (67%), the ER/PR result of the DCIS after surgical excision did not impact therapy.” All of these were ER-positive cases, including 4 patients who opted for bilateral mastectomies (no subsequent role for neoadjuvant therapy), 8 who declined to meet with an oncologist, 1 for whom hormone therapy was contraindicated, 8 (of 8) who declined hormone therapy when their Hopkins oncologist did not recommend it, 10 (of 20) who declined hormone therapy when their Hopkins oncologist was neutral about its risk/benefit ratio, 1 (of 2) who declined hormone therapy when the Hopkins oncologist recommended it, and the 1 patient (of 3) who declined hormone therapy after visiting a non-Hopkins oncologist.

After reviewing the costs associated with these cases, “we found that ER testing … costing $20,685.72 ($357 per patient) had been performed unnecessarily,” the investigators said. In addition, if the PR testing – which has never been proven clinically important in DCIS – had been eliminated, there would have been an additional $86.46 savings per patient, a total savings of $5,014.

“Extrapolating the increased cost of $583 per DCIS diagnosis on core needle biopsy to 60,000 new cases of DCIS in the United States each year, reflex core needle biopsy ER/PR testing unnecessarily increases costs by approximately $35 million,” the authors said. “We recommend that ER/PR not be reflexively ordered on core needle biopsy specimens or surgical excision specimens containing DCIS, but instead that ER alone be performed on surgical excision specimens only when hormone therapy is a serious consideration after medical oncology consultation.”

 

 

The group noted that this total reflects the total amount billed, not typical reimbursement. “Regardless,” they said, “the cost of this testing is staggering.”

The authors did not mention the study’s funding source. They had no relevant financial disclosures.

[email protected]

On Twitter @Alz_Gal

Limiting hormone receptor testing of diagnostic core biopisies containing ductal carcinoma in situ (DCIS) could save up to $35 million in associated health care costs every year in the United States.

The results of a cost analysis conducted by researchers at Johns Hopkins University were so striking that the hospital has now eliminated reflex testing of core needle biopsies for DCIS, Christopher J. VandenBussche, MD, and his colleagues wrote in the American Journal of Surgical Pathology (2016;40:1090-9).

“We suggest that reflex [hormone receptor] testing of core needle biopsy specimens harboring DCIS should not be performed, as the results do not guide the next step in therapy,” wrote Dr. VandenBussche of Johns Hopkins University, Baltimore. “On the basis of this study, we have convinced our clinicians and no longer reflexively perform estrogen- and progesterone-receptor [ER/PR] testing on core needle biopsy specimens with DCIS at Hopkins and encourage other institutions to follow suit.”

Conducting expensive hormone receptor testing of these biopsy samples before surgery doesn’t make clinical or financial sense, for several reasons, the team said:

• Hormone receptor status at biopsy has no effect on the next treatment step, as DCIS patients always progress first to surgical excision, not neoadjuvant hormone therapy.

• Surgery sometimes reveals extensive breast cancer in patents with pure DCIS, and these cancers will always need ER/PR testing, rendering irrelevant biopsy testing.

• Because ER and PR labeling are often heterogeneous in DCIS, negative results for ER/PR on small core needle biopsy specimens would have to be repeated anyway on surgical excision specimens with larger amounts of DCIS, to be sure that the result is truly negative.

• Hormone therapy for DCIS does decrease recurrence, but it doesn’t impact survival – and it does carry significant adverse effects. Therefore, many women refuse hormone therapy if they do have ER/PR-positive tumors.

• The independent role of PR status in DCIS is unproven, so testing for it is not supported by clinical evidence.

To examine the costs associated with reflexive ER/PR testing, the investigators reviewed 58 core needle biopsies of pure DCIS followed by surgical excision. None of the patients had neoadjuvant hormone therapy. Of the 58 tumors, 76% were pure DCIS, and 16% were DCIS with invasive breast cancer. Most of the DCIS (47) tumors were ER+/PR+; 6 were ER-/PR-; and 5 were ER+/PR-.

The team reviewed the records of 49 patients who underwent surgical excision and ended up with a diagnosis of pure DCIS. These included 46 ER-positive cases, and 3 that were ER-negative in both biopsy and excision.

The findings suggested that ER/PR results from either the biopsy and the surgical excision samples were relevant to therapy in only a portion of these patients.

“We found that the ER/PR results after surgical excision impacted therapy in at most only 16 of 49 cases (33%),” they said. These included the 3 ER-/PR-negative cases, which would, in any case, not have triggered hormone therapy; 10 patients who chose hormone therapy despite a Hopkins oncologist’s neutral recommendation; 1 of 2 who took hormone therapy on a Hopkins oncologist’s recommendation; and 2 of 3 who took it after seeing a non-Hopkins oncologist.

“In contrast,” the authors wrote, “in 33 of the cases (67%), the ER/PR result of the DCIS after surgical excision did not impact therapy.” All of these were ER-positive cases, including 4 patients who opted for bilateral mastectomies (no subsequent role for neoadjuvant therapy), 8 who declined to meet with an oncologist, 1 for whom hormone therapy was contraindicated, 8 (of 8) who declined hormone therapy when their Hopkins oncologist did not recommend it, 10 (of 20) who declined hormone therapy when their Hopkins oncologist was neutral about its risk/benefit ratio, 1 (of 2) who declined hormone therapy when the Hopkins oncologist recommended it, and the 1 patient (of 3) who declined hormone therapy after visiting a non-Hopkins oncologist.

After reviewing the costs associated with these cases, “we found that ER testing … costing $20,685.72 ($357 per patient) had been performed unnecessarily,” the investigators said. In addition, if the PR testing – which has never been proven clinically important in DCIS – had been eliminated, there would have been an additional $86.46 savings per patient, a total savings of $5,014.

“Extrapolating the increased cost of $583 per DCIS diagnosis on core needle biopsy to 60,000 new cases of DCIS in the United States each year, reflex core needle biopsy ER/PR testing unnecessarily increases costs by approximately $35 million,” the authors said. “We recommend that ER/PR not be reflexively ordered on core needle biopsy specimens or surgical excision specimens containing DCIS, but instead that ER alone be performed on surgical excision specimens only when hormone therapy is a serious consideration after medical oncology consultation.”

 

 

The group noted that this total reflects the total amount billed, not typical reimbursement. “Regardless,” they said, “the cost of this testing is staggering.”

The authors did not mention the study’s funding source. They had no relevant financial disclosures.

[email protected]

On Twitter @Alz_Gal

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Key clinical point: Hormone receptor testing of diagnostic core needle biopsies should not be automatic.

Major finding: Limiting testing to excised surgical section specimens could save up to $35 million a year in the United States.

Data source: The cost analysis examined testing and treatment of 58 patients with ductal carcinoma in situ.

Disclosures: The authors had no relevant financial disclosures.

Different approaches can combat negative online reviews

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Different approaches can combat negative online reviews

Like most physicians, Dr. Susan Hardwick-Smith was used to receiving the occasional negative online review about her practice. But a biting post from several years ago was so wrenching that it nearly drove the Houston ob.gyn. out of medicine for good.

The patient blasted Dr. Hardwick-Smith on a popular review site about her care during a delivery and accused the doctor of attempting to force an unnecessary C-section. The account was inaccurate, but privacy laws prevented Dr. Hardwick-Smith from defending herself online or sharing details of the actual encounter, she said.

Dr. Susan Hardwick-Smith

“She wrote this very detailed account of what a terrible doctor I was, and in my version of reality, I had saved her baby’s life,” said Dr. Hardwick-Smith. “I felt extremely powerless. I lost a lot of sleep over it, and I was considering giving up delivering babies. It was a real turning point for me.”

Rather than hanging up her white coat, Dr. Hardwick-Smith began working with an online reputation company – eMerit – that works to dilute negative reviews by soliciting a greater number of reviews from patients. The offensive post is now buried under hundreds of other reviews that are primarily positive, she said.

Hiring a reputation management company is one strategy for coping with negative online reviews. But cyberlaw experts stress that removing negative posts altogether is no easy feat. The best move to take often depends on the post, the patient, and the circumstance.

By now, it’s no secret that negative online reviews can significantly impact a medical practice, from influencing patient recruitment to affecting practice revenue to ruining a reputation. A 2015 survey of 2,354 consumers by search marketing firm BrightLocal found that 92% of consumers read online reviews – up from 67% in 2010 – and 40% of consumers had formed an opinion by reading just one to three reviews. Of 2,137 patients who viewed online reviews, 35% selected a physician based on positive reviews, while 37% avoided doctors with negative reviews, according to a 2014 study in JAMA (doi:10.1001/jama.2013.283194).

Peter Yelkovac

Reviews have become a strong force in the health care industry, said Peter Yelkovac, an online defamation attorney in Northern Indiana.

“Online reviews have really replaced the common ‘word of mouth’ that used to be the primary source for doctors referrals,” Mr. Yelkovac said in an interview. “Now, [patients] go online. Anyone can type anything they want, whether it’s truthful, untruthful, positive, indifferent, or negative.”

Doctor vs. website

In some cases, contacting a website administrator and requesting a review be removed can end the dilemma, said Michael J. Sacopulos, a medical malpractice defense attorney based in Terre Haute, Ind.

Rating sites generally have “terms of use,” and posts that violate the terms usually will be taken down by site administrators with some nudging, Mr. Sacopulos said in an interview. Other sites have “strike policies,” where a reviewee can request that one or two negative reviews be removed.

Michael J. Sacopulos

Still other sites are not as accommodating. Amazon, for instance, has immunity against content posted on the site, Mr. Sacopulos said. Under the Communications Decency Act, interactive computer services, such as a consumer review website, cannot be liable for content independently created or developed by third-party users. Such sites are hardly motivated to remove negative comments when racy posts can drive traffic to the site, he said.

Eric M. Joseph, MD, a facial plastic surgeon in West Orange, N.J., learned this lesson firsthand when he attempted to have a video removed from YouTube. A poster had uploaded copyright-protected before and after photos from Dr. Joseph’s practice onto YouTube and made disparaging comments about the patients in a video that went viral. Dr. Joseph and the patient both flagged the video for removal, but to no avail.

“It was impossible to [talk to] a human being at Google,” Dr, Joseph said. “It almost didn’t come down, and we were in conversations about suing Google. It took months and a cyberattorney who specializes in copyright infringement.”

Dr. Eric M. Joseph

The video finally was removed, but not before Dr. Joseph spent $6,000 in legal fees and experienced significant distress from the incident. Although most reviews about his practice are positive, he said, it’s difficult not to be affected by negative posts.

“From a psychological standpoint, it stings,” he said. “The burn of a negative review outweighs the sweetness of a positive review 100 times.”

Reputation companies to the rescue?

Like Dr. Hardwick-Smith, Dr. Joseph has utilized the online reputation management company eMerit to improve his online presence. The company gathers reviews from patients at the point of service and posts them to dominate review sites.

 

 

The solution to pollution is dilution, which means counterbalancing negative reviews with more representative reviews,” said Jeffrey Segal, MD, a neurosurgeon and attorney, and the founder of eMerit. “The next step is to deescalate conflict if you know who the patient is – to see if the patient problem can be resolved. Typically a patient is pleasantly surprised that you took the effort to call. Because the bar is so low, it’s very easy to exceed it.”

Dr. Jeffrey Segal

Physicians subscribe to eMerit on a month-to-month basis, paying $100-$600 a month, depending on the practice’s needs, Dr. Segal said. He touted a greater than 90% renewal rate, and said eMerit has captured and uploaded more than 150,000 patient reviews since its inception.

For the online reputation management company Reputation.com, health care providers have become one of the its most frequent clients, said Michael Fertik, company founder. Reputation.com solicits reviews from patients after appointments and ensures their visibility on top review sites. The platform also integrates reviews from general and health care review sites to help providers address patient feedback and receive alerts when negative reviews are posted. Rates start at $50 a month.

Mr. Fertik noted that more reviews not only overtake negative posts, but they make physicians easier to find by patients.

“If you have more than 10-15 reviews, you have a higher chance of getting a new patient because the search engine is going to favor doctors that have more reviews,” he said. “Doctors that have a small number of reviews don’t exist as far as search engines are concerned.”

However, all online reputation management firms are not equal, Mr. Sacopulos warned. Some are unfamiliar with the health care space, while others are unclear on health care privacy regulations. Mr. Sacopulos learned of a company that was sending patients texts to request reviews, which was likely a privacy violation and a violation of the Telecommunications Act, he said.

““Some [companies] are much more credible, and they understand health care law more than others,” he said. “Some have the technological capabilities to do things, but don’t understand the legal environment, so you need to be very careful [about whom] you pick.”

Time to sue?

Litigation is generally the last resort to fighting unfavorable online reviews. If a doctor believes a review is unfair or defamatory, and all other efforts have been exhausted, a lawyer may be able to help, Mr. Yelkovac said.

“When someone says, ‘I want to sue,’ that’s a possibility, but that’s typically far down the road,” he said. “Lawsuits are expensive. Lawsuits have an unknown outcome, and I would say, many times when you do sue for defamation, [the poster] may or may not have a lot of money, so you may end up spending a lot of money and you don’t recover anything from the patient.”

The majority of the lawsuits Mr. Yelkovac handles related to online reviews seek to unmask the poster with the aid of subpoenas and at times computer forensics, he said. From there, doctors can decide which action to take, such as contacting the poster and asking to have the comment removed.

“Sometimes it’s a surprise,” he said. “Sometimes it’s an ex-employee. Sometimes it’s a family member, or it could potentially be a competitor. Many times it’s not even a patient, and sometimes it’s a patient [who] the doctor never thought would post a review.”

Reviews and malpractice risk

Remember that not all unfavorable reviews are necessarily negative for physicians, said Brant Avondet, founder of Searchlight Enterprises, a malpractice risk prediction and online physician ratings research company.

Brant Avondet

A pattern of reviews that express the same concerns or frustrations by patients can be used to address and change internal policies and problems, such as multiple complaints about long wait times or a crowded parking lot, he said. Perhaps the front desk staff is repeatedly unfriendly to patients. Taking steps to correct these concerns could help in the long run, Mr. Avondet said.

Searchlight Enterprises recently presented study findings about a suggested link between online ratings and legal risk for physicians at a national medical insurance conference. Mr. Avondet and his colleagues evaluated claims data for 4,000 Florida physicians from the Florida Healthcare Practitioner Data Portal from 2000 to 2016 and studied online physician reviews from top rating sites. Doctors were grouped into three categories: surgical, ob.gyn., and “other” specialties. Findings showed the bottom 10% of surgeons studied (those with the worst online reviews) had 150% as many claims as the average for all surgeons. Surgeons in the top 20% (doctors with the best online reviews) had roughly half of the risk of a claim, compared with the average surgeon. Similar results were found for ob.gyns. and other specialties.

 

 

“Low and behold, there’s a huge correlation,” Mr. Avondet said. “There’s no shadow of a doubt that there’s something there that predicts your malpractice risk based on how nice or mean you are in the eyes of the patient.”

Mr. Avondet said he encourages physicians to use online reviews to make improvements, thus lowering their liability.

“Look at these reviews as a lens into your practice and things you might need to correct,” he said. “Use it as [insight] for how you can improve your practice and decrease the risk of getting sued.”

[email protected]

On Twitter @legal_med

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Like most physicians, Dr. Susan Hardwick-Smith was used to receiving the occasional negative online review about her practice. But a biting post from several years ago was so wrenching that it nearly drove the Houston ob.gyn. out of medicine for good.

The patient blasted Dr. Hardwick-Smith on a popular review site about her care during a delivery and accused the doctor of attempting to force an unnecessary C-section. The account was inaccurate, but privacy laws prevented Dr. Hardwick-Smith from defending herself online or sharing details of the actual encounter, she said.

Dr. Susan Hardwick-Smith

“She wrote this very detailed account of what a terrible doctor I was, and in my version of reality, I had saved her baby’s life,” said Dr. Hardwick-Smith. “I felt extremely powerless. I lost a lot of sleep over it, and I was considering giving up delivering babies. It was a real turning point for me.”

Rather than hanging up her white coat, Dr. Hardwick-Smith began working with an online reputation company – eMerit – that works to dilute negative reviews by soliciting a greater number of reviews from patients. The offensive post is now buried under hundreds of other reviews that are primarily positive, she said.

Hiring a reputation management company is one strategy for coping with negative online reviews. But cyberlaw experts stress that removing negative posts altogether is no easy feat. The best move to take often depends on the post, the patient, and the circumstance.

By now, it’s no secret that negative online reviews can significantly impact a medical practice, from influencing patient recruitment to affecting practice revenue to ruining a reputation. A 2015 survey of 2,354 consumers by search marketing firm BrightLocal found that 92% of consumers read online reviews – up from 67% in 2010 – and 40% of consumers had formed an opinion by reading just one to three reviews. Of 2,137 patients who viewed online reviews, 35% selected a physician based on positive reviews, while 37% avoided doctors with negative reviews, according to a 2014 study in JAMA (doi:10.1001/jama.2013.283194).

Peter Yelkovac

Reviews have become a strong force in the health care industry, said Peter Yelkovac, an online defamation attorney in Northern Indiana.

“Online reviews have really replaced the common ‘word of mouth’ that used to be the primary source for doctors referrals,” Mr. Yelkovac said in an interview. “Now, [patients] go online. Anyone can type anything they want, whether it’s truthful, untruthful, positive, indifferent, or negative.”

Doctor vs. website

In some cases, contacting a website administrator and requesting a review be removed can end the dilemma, said Michael J. Sacopulos, a medical malpractice defense attorney based in Terre Haute, Ind.

Rating sites generally have “terms of use,” and posts that violate the terms usually will be taken down by site administrators with some nudging, Mr. Sacopulos said in an interview. Other sites have “strike policies,” where a reviewee can request that one or two negative reviews be removed.

Michael J. Sacopulos

Still other sites are not as accommodating. Amazon, for instance, has immunity against content posted on the site, Mr. Sacopulos said. Under the Communications Decency Act, interactive computer services, such as a consumer review website, cannot be liable for content independently created or developed by third-party users. Such sites are hardly motivated to remove negative comments when racy posts can drive traffic to the site, he said.

Eric M. Joseph, MD, a facial plastic surgeon in West Orange, N.J., learned this lesson firsthand when he attempted to have a video removed from YouTube. A poster had uploaded copyright-protected before and after photos from Dr. Joseph’s practice onto YouTube and made disparaging comments about the patients in a video that went viral. Dr. Joseph and the patient both flagged the video for removal, but to no avail.

“It was impossible to [talk to] a human being at Google,” Dr, Joseph said. “It almost didn’t come down, and we were in conversations about suing Google. It took months and a cyberattorney who specializes in copyright infringement.”

Dr. Eric M. Joseph

The video finally was removed, but not before Dr. Joseph spent $6,000 in legal fees and experienced significant distress from the incident. Although most reviews about his practice are positive, he said, it’s difficult not to be affected by negative posts.

“From a psychological standpoint, it stings,” he said. “The burn of a negative review outweighs the sweetness of a positive review 100 times.”

Reputation companies to the rescue?

Like Dr. Hardwick-Smith, Dr. Joseph has utilized the online reputation management company eMerit to improve his online presence. The company gathers reviews from patients at the point of service and posts them to dominate review sites.

 

 

The solution to pollution is dilution, which means counterbalancing negative reviews with more representative reviews,” said Jeffrey Segal, MD, a neurosurgeon and attorney, and the founder of eMerit. “The next step is to deescalate conflict if you know who the patient is – to see if the patient problem can be resolved. Typically a patient is pleasantly surprised that you took the effort to call. Because the bar is so low, it’s very easy to exceed it.”

Dr. Jeffrey Segal

Physicians subscribe to eMerit on a month-to-month basis, paying $100-$600 a month, depending on the practice’s needs, Dr. Segal said. He touted a greater than 90% renewal rate, and said eMerit has captured and uploaded more than 150,000 patient reviews since its inception.

For the online reputation management company Reputation.com, health care providers have become one of the its most frequent clients, said Michael Fertik, company founder. Reputation.com solicits reviews from patients after appointments and ensures their visibility on top review sites. The platform also integrates reviews from general and health care review sites to help providers address patient feedback and receive alerts when negative reviews are posted. Rates start at $50 a month.

Mr. Fertik noted that more reviews not only overtake negative posts, but they make physicians easier to find by patients.

“If you have more than 10-15 reviews, you have a higher chance of getting a new patient because the search engine is going to favor doctors that have more reviews,” he said. “Doctors that have a small number of reviews don’t exist as far as search engines are concerned.”

However, all online reputation management firms are not equal, Mr. Sacopulos warned. Some are unfamiliar with the health care space, while others are unclear on health care privacy regulations. Mr. Sacopulos learned of a company that was sending patients texts to request reviews, which was likely a privacy violation and a violation of the Telecommunications Act, he said.

““Some [companies] are much more credible, and they understand health care law more than others,” he said. “Some have the technological capabilities to do things, but don’t understand the legal environment, so you need to be very careful [about whom] you pick.”

Time to sue?

Litigation is generally the last resort to fighting unfavorable online reviews. If a doctor believes a review is unfair or defamatory, and all other efforts have been exhausted, a lawyer may be able to help, Mr. Yelkovac said.

“When someone says, ‘I want to sue,’ that’s a possibility, but that’s typically far down the road,” he said. “Lawsuits are expensive. Lawsuits have an unknown outcome, and I would say, many times when you do sue for defamation, [the poster] may or may not have a lot of money, so you may end up spending a lot of money and you don’t recover anything from the patient.”

The majority of the lawsuits Mr. Yelkovac handles related to online reviews seek to unmask the poster with the aid of subpoenas and at times computer forensics, he said. From there, doctors can decide which action to take, such as contacting the poster and asking to have the comment removed.

“Sometimes it’s a surprise,” he said. “Sometimes it’s an ex-employee. Sometimes it’s a family member, or it could potentially be a competitor. Many times it’s not even a patient, and sometimes it’s a patient [who] the doctor never thought would post a review.”

Reviews and malpractice risk

Remember that not all unfavorable reviews are necessarily negative for physicians, said Brant Avondet, founder of Searchlight Enterprises, a malpractice risk prediction and online physician ratings research company.

Brant Avondet

A pattern of reviews that express the same concerns or frustrations by patients can be used to address and change internal policies and problems, such as multiple complaints about long wait times or a crowded parking lot, he said. Perhaps the front desk staff is repeatedly unfriendly to patients. Taking steps to correct these concerns could help in the long run, Mr. Avondet said.

Searchlight Enterprises recently presented study findings about a suggested link between online ratings and legal risk for physicians at a national medical insurance conference. Mr. Avondet and his colleagues evaluated claims data for 4,000 Florida physicians from the Florida Healthcare Practitioner Data Portal from 2000 to 2016 and studied online physician reviews from top rating sites. Doctors were grouped into three categories: surgical, ob.gyn., and “other” specialties. Findings showed the bottom 10% of surgeons studied (those with the worst online reviews) had 150% as many claims as the average for all surgeons. Surgeons in the top 20% (doctors with the best online reviews) had roughly half of the risk of a claim, compared with the average surgeon. Similar results were found for ob.gyns. and other specialties.

 

 

“Low and behold, there’s a huge correlation,” Mr. Avondet said. “There’s no shadow of a doubt that there’s something there that predicts your malpractice risk based on how nice or mean you are in the eyes of the patient.”

Mr. Avondet said he encourages physicians to use online reviews to make improvements, thus lowering their liability.

“Look at these reviews as a lens into your practice and things you might need to correct,” he said. “Use it as [insight] for how you can improve your practice and decrease the risk of getting sued.”

[email protected]

On Twitter @legal_med

Like most physicians, Dr. Susan Hardwick-Smith was used to receiving the occasional negative online review about her practice. But a biting post from several years ago was so wrenching that it nearly drove the Houston ob.gyn. out of medicine for good.

The patient blasted Dr. Hardwick-Smith on a popular review site about her care during a delivery and accused the doctor of attempting to force an unnecessary C-section. The account was inaccurate, but privacy laws prevented Dr. Hardwick-Smith from defending herself online or sharing details of the actual encounter, she said.

Dr. Susan Hardwick-Smith

“She wrote this very detailed account of what a terrible doctor I was, and in my version of reality, I had saved her baby’s life,” said Dr. Hardwick-Smith. “I felt extremely powerless. I lost a lot of sleep over it, and I was considering giving up delivering babies. It was a real turning point for me.”

Rather than hanging up her white coat, Dr. Hardwick-Smith began working with an online reputation company – eMerit – that works to dilute negative reviews by soliciting a greater number of reviews from patients. The offensive post is now buried under hundreds of other reviews that are primarily positive, she said.

Hiring a reputation management company is one strategy for coping with negative online reviews. But cyberlaw experts stress that removing negative posts altogether is no easy feat. The best move to take often depends on the post, the patient, and the circumstance.

By now, it’s no secret that negative online reviews can significantly impact a medical practice, from influencing patient recruitment to affecting practice revenue to ruining a reputation. A 2015 survey of 2,354 consumers by search marketing firm BrightLocal found that 92% of consumers read online reviews – up from 67% in 2010 – and 40% of consumers had formed an opinion by reading just one to three reviews. Of 2,137 patients who viewed online reviews, 35% selected a physician based on positive reviews, while 37% avoided doctors with negative reviews, according to a 2014 study in JAMA (doi:10.1001/jama.2013.283194).

Peter Yelkovac

Reviews have become a strong force in the health care industry, said Peter Yelkovac, an online defamation attorney in Northern Indiana.

“Online reviews have really replaced the common ‘word of mouth’ that used to be the primary source for doctors referrals,” Mr. Yelkovac said in an interview. “Now, [patients] go online. Anyone can type anything they want, whether it’s truthful, untruthful, positive, indifferent, or negative.”

Doctor vs. website

In some cases, contacting a website administrator and requesting a review be removed can end the dilemma, said Michael J. Sacopulos, a medical malpractice defense attorney based in Terre Haute, Ind.

Rating sites generally have “terms of use,” and posts that violate the terms usually will be taken down by site administrators with some nudging, Mr. Sacopulos said in an interview. Other sites have “strike policies,” where a reviewee can request that one or two negative reviews be removed.

Michael J. Sacopulos

Still other sites are not as accommodating. Amazon, for instance, has immunity against content posted on the site, Mr. Sacopulos said. Under the Communications Decency Act, interactive computer services, such as a consumer review website, cannot be liable for content independently created or developed by third-party users. Such sites are hardly motivated to remove negative comments when racy posts can drive traffic to the site, he said.

Eric M. Joseph, MD, a facial plastic surgeon in West Orange, N.J., learned this lesson firsthand when he attempted to have a video removed from YouTube. A poster had uploaded copyright-protected before and after photos from Dr. Joseph’s practice onto YouTube and made disparaging comments about the patients in a video that went viral. Dr. Joseph and the patient both flagged the video for removal, but to no avail.

“It was impossible to [talk to] a human being at Google,” Dr, Joseph said. “It almost didn’t come down, and we were in conversations about suing Google. It took months and a cyberattorney who specializes in copyright infringement.”

Dr. Eric M. Joseph

The video finally was removed, but not before Dr. Joseph spent $6,000 in legal fees and experienced significant distress from the incident. Although most reviews about his practice are positive, he said, it’s difficult not to be affected by negative posts.

“From a psychological standpoint, it stings,” he said. “The burn of a negative review outweighs the sweetness of a positive review 100 times.”

Reputation companies to the rescue?

Like Dr. Hardwick-Smith, Dr. Joseph has utilized the online reputation management company eMerit to improve his online presence. The company gathers reviews from patients at the point of service and posts them to dominate review sites.

 

 

The solution to pollution is dilution, which means counterbalancing negative reviews with more representative reviews,” said Jeffrey Segal, MD, a neurosurgeon and attorney, and the founder of eMerit. “The next step is to deescalate conflict if you know who the patient is – to see if the patient problem can be resolved. Typically a patient is pleasantly surprised that you took the effort to call. Because the bar is so low, it’s very easy to exceed it.”

Dr. Jeffrey Segal

Physicians subscribe to eMerit on a month-to-month basis, paying $100-$600 a month, depending on the practice’s needs, Dr. Segal said. He touted a greater than 90% renewal rate, and said eMerit has captured and uploaded more than 150,000 patient reviews since its inception.

For the online reputation management company Reputation.com, health care providers have become one of the its most frequent clients, said Michael Fertik, company founder. Reputation.com solicits reviews from patients after appointments and ensures their visibility on top review sites. The platform also integrates reviews from general and health care review sites to help providers address patient feedback and receive alerts when negative reviews are posted. Rates start at $50 a month.

Mr. Fertik noted that more reviews not only overtake negative posts, but they make physicians easier to find by patients.

“If you have more than 10-15 reviews, you have a higher chance of getting a new patient because the search engine is going to favor doctors that have more reviews,” he said. “Doctors that have a small number of reviews don’t exist as far as search engines are concerned.”

However, all online reputation management firms are not equal, Mr. Sacopulos warned. Some are unfamiliar with the health care space, while others are unclear on health care privacy regulations. Mr. Sacopulos learned of a company that was sending patients texts to request reviews, which was likely a privacy violation and a violation of the Telecommunications Act, he said.

““Some [companies] are much more credible, and they understand health care law more than others,” he said. “Some have the technological capabilities to do things, but don’t understand the legal environment, so you need to be very careful [about whom] you pick.”

Time to sue?

Litigation is generally the last resort to fighting unfavorable online reviews. If a doctor believes a review is unfair or defamatory, and all other efforts have been exhausted, a lawyer may be able to help, Mr. Yelkovac said.

“When someone says, ‘I want to sue,’ that’s a possibility, but that’s typically far down the road,” he said. “Lawsuits are expensive. Lawsuits have an unknown outcome, and I would say, many times when you do sue for defamation, [the poster] may or may not have a lot of money, so you may end up spending a lot of money and you don’t recover anything from the patient.”

The majority of the lawsuits Mr. Yelkovac handles related to online reviews seek to unmask the poster with the aid of subpoenas and at times computer forensics, he said. From there, doctors can decide which action to take, such as contacting the poster and asking to have the comment removed.

“Sometimes it’s a surprise,” he said. “Sometimes it’s an ex-employee. Sometimes it’s a family member, or it could potentially be a competitor. Many times it’s not even a patient, and sometimes it’s a patient [who] the doctor never thought would post a review.”

Reviews and malpractice risk

Remember that not all unfavorable reviews are necessarily negative for physicians, said Brant Avondet, founder of Searchlight Enterprises, a malpractice risk prediction and online physician ratings research company.

Brant Avondet

A pattern of reviews that express the same concerns or frustrations by patients can be used to address and change internal policies and problems, such as multiple complaints about long wait times or a crowded parking lot, he said. Perhaps the front desk staff is repeatedly unfriendly to patients. Taking steps to correct these concerns could help in the long run, Mr. Avondet said.

Searchlight Enterprises recently presented study findings about a suggested link between online ratings and legal risk for physicians at a national medical insurance conference. Mr. Avondet and his colleagues evaluated claims data for 4,000 Florida physicians from the Florida Healthcare Practitioner Data Portal from 2000 to 2016 and studied online physician reviews from top rating sites. Doctors were grouped into three categories: surgical, ob.gyn., and “other” specialties. Findings showed the bottom 10% of surgeons studied (those with the worst online reviews) had 150% as many claims as the average for all surgeons. Surgeons in the top 20% (doctors with the best online reviews) had roughly half of the risk of a claim, compared with the average surgeon. Similar results were found for ob.gyns. and other specialties.

 

 

“Low and behold, there’s a huge correlation,” Mr. Avondet said. “There’s no shadow of a doubt that there’s something there that predicts your malpractice risk based on how nice or mean you are in the eyes of the patient.”

Mr. Avondet said he encourages physicians to use online reviews to make improvements, thus lowering their liability.

“Look at these reviews as a lens into your practice and things you might need to correct,” he said. “Use it as [insight] for how you can improve your practice and decrease the risk of getting sued.”

[email protected]

On Twitter @legal_med

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No one-size-fits-all approach for reducing hospital readmissions

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SAN DIEGO – Despite advances in the way surgeons practice their craft and measure outcomes in a meaningful way, the rate of hospital readmissions remains unacceptably high, according to an Emory University surgeon who has studied the readmission patterns.

“Readmission is a problem, not only from a cost and penalties standpoint but also from the rates of readmission affecting patients’ lives and expectations,” Jyotirmay Sharma, MD, said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

Dr. Jyotirmay Sharma

Dr. Sharma, director of thyroid and endocrine surgery at Emory University Hospital, Atlanta, cited recent federal data estimating that among Medicare patients discharged from a hospital, 20% are rehospitalized within 30 days, and 34% are rehospitalized within 90 days. In 2013 alone, the Centers for Medicare & Medicaid Services levied readmission penalties against 2,213 hospitals to the tune of $280 million. “So clearly it’s a major issue,” he said.

In a study conducted by one of Dr. Sharma’s associates, researchers evaluated the risk factors for 30-day hospital readmission among general surgery patients treated at Emory University Hospital (J Am Coll Surg. 2012 Sep;215[3]:322-30). Pancreatectomy accounted for 18% of readmissions, followed by colectomy/colostomy (13%), small bowel resection (12%), and gastrectomy and ventral hernia repair (both 11%).

An unrelated analysis of a 498,875 operations found that lower extremity vascular bypass procedures accounted for 16% of readmissions, followed by colectomy or proctectomy (11%), bariatric surgery (5%), and ventral hernia repair (4%). In addition, the readmission rates were 6% among patients with no complications, 16% among those with one complications such as surgical site infections (SSIs), bleeding, and ileus, 37% among those with two or more complications, and 29% among those with three or more complications (JAMA 2015;313[3]:483-95). The most common complication overall was SSI (20%), followed by ileus (10%).

When the Emory study researchers drilled down on their data, they found that the following preexisting conditions were associated with readmissions among colectomy patients: steroid use, hypertension, readmission, cancer, COPD, smoking, poor functional status, and diabetes. At the same time, preexisting conditions associated with readmissions among vascular patients were diabetes and renal failure. The only preexisting condition associated with readmissions among thyroidectomy was renal failure. When the researchers evaluated the association between readmission risk and system-wide complications, they found that vascular surgery and urinary surgery conferred the highest risks (sixfold and fivefold, respectively).

“Just looking at your semiannual report quickly can give you a sense of which complications are associated with that readmission,” Dr. Sharma said. “There are many areas of potential intervention.” Preoperatively, he recommends screening surgery patients for obstructive sleep apnea, hypertension, and diabetes. “Looking at preexisting comorbid dyspnea, cancer, and renal failure can give you those target populations very quickly,” he said.

Intraoperatively, “it’s all about reduction of complications,” he said. These include using the WHO checklist, employing SSI prevention practices and considering certain anesthesia techniques such as low tidal volume ventilation and fluid limitation, control of hyperglycemia, and enhanced recovery after surgery protocols (ERAS).

Postoperative strategies to reduce readmission risk include ERAS for multimodal analgesia, fluid restriction, oral intake, and ambulation, and being aggressive about follow-up with high-risk populations and discharge planning. “The strategies for readmission reduction should be based on the preoperative assessment and the ability to identify high-risk populations,” Dr. Sharma said. “At Emory, we found that ileostomy patients had the highest risk of readmission. This made sense from a dehydration standpoint. So a colorectal surgeon led the creation of an Emory-wide protocol for teaching patients and their families, giving them signs of dehydration, what to look for, direct access to a dedicated nurse for follow-up, and an arrangement with the infusion center for rehydration as needed.”

He concluded by noting that there is no one-size-fits-all approach to reducing hospital readmissions. “I think an overarching readmission improvement process is not the way to go, unless you’re talking about a preoperative assessment area,” he said. “Identifying high-risk patients and giving them a lifeline where they can call so you can intervene and avoid that readmission, is better.”

Dr. Sharma reported having no relevant disclosures.

[email protected]

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SAN DIEGO – Despite advances in the way surgeons practice their craft and measure outcomes in a meaningful way, the rate of hospital readmissions remains unacceptably high, according to an Emory University surgeon who has studied the readmission patterns.

“Readmission is a problem, not only from a cost and penalties standpoint but also from the rates of readmission affecting patients’ lives and expectations,” Jyotirmay Sharma, MD, said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

Dr. Jyotirmay Sharma

Dr. Sharma, director of thyroid and endocrine surgery at Emory University Hospital, Atlanta, cited recent federal data estimating that among Medicare patients discharged from a hospital, 20% are rehospitalized within 30 days, and 34% are rehospitalized within 90 days. In 2013 alone, the Centers for Medicare & Medicaid Services levied readmission penalties against 2,213 hospitals to the tune of $280 million. “So clearly it’s a major issue,” he said.

In a study conducted by one of Dr. Sharma’s associates, researchers evaluated the risk factors for 30-day hospital readmission among general surgery patients treated at Emory University Hospital (J Am Coll Surg. 2012 Sep;215[3]:322-30). Pancreatectomy accounted for 18% of readmissions, followed by colectomy/colostomy (13%), small bowel resection (12%), and gastrectomy and ventral hernia repair (both 11%).

An unrelated analysis of a 498,875 operations found that lower extremity vascular bypass procedures accounted for 16% of readmissions, followed by colectomy or proctectomy (11%), bariatric surgery (5%), and ventral hernia repair (4%). In addition, the readmission rates were 6% among patients with no complications, 16% among those with one complications such as surgical site infections (SSIs), bleeding, and ileus, 37% among those with two or more complications, and 29% among those with three or more complications (JAMA 2015;313[3]:483-95). The most common complication overall was SSI (20%), followed by ileus (10%).

When the Emory study researchers drilled down on their data, they found that the following preexisting conditions were associated with readmissions among colectomy patients: steroid use, hypertension, readmission, cancer, COPD, smoking, poor functional status, and diabetes. At the same time, preexisting conditions associated with readmissions among vascular patients were diabetes and renal failure. The only preexisting condition associated with readmissions among thyroidectomy was renal failure. When the researchers evaluated the association between readmission risk and system-wide complications, they found that vascular surgery and urinary surgery conferred the highest risks (sixfold and fivefold, respectively).

“Just looking at your semiannual report quickly can give you a sense of which complications are associated with that readmission,” Dr. Sharma said. “There are many areas of potential intervention.” Preoperatively, he recommends screening surgery patients for obstructive sleep apnea, hypertension, and diabetes. “Looking at preexisting comorbid dyspnea, cancer, and renal failure can give you those target populations very quickly,” he said.

Intraoperatively, “it’s all about reduction of complications,” he said. These include using the WHO checklist, employing SSI prevention practices and considering certain anesthesia techniques such as low tidal volume ventilation and fluid limitation, control of hyperglycemia, and enhanced recovery after surgery protocols (ERAS).

Postoperative strategies to reduce readmission risk include ERAS for multimodal analgesia, fluid restriction, oral intake, and ambulation, and being aggressive about follow-up with high-risk populations and discharge planning. “The strategies for readmission reduction should be based on the preoperative assessment and the ability to identify high-risk populations,” Dr. Sharma said. “At Emory, we found that ileostomy patients had the highest risk of readmission. This made sense from a dehydration standpoint. So a colorectal surgeon led the creation of an Emory-wide protocol for teaching patients and their families, giving them signs of dehydration, what to look for, direct access to a dedicated nurse for follow-up, and an arrangement with the infusion center for rehydration as needed.”

He concluded by noting that there is no one-size-fits-all approach to reducing hospital readmissions. “I think an overarching readmission improvement process is not the way to go, unless you’re talking about a preoperative assessment area,” he said. “Identifying high-risk patients and giving them a lifeline where they can call so you can intervene and avoid that readmission, is better.”

Dr. Sharma reported having no relevant disclosures.

[email protected]

SAN DIEGO – Despite advances in the way surgeons practice their craft and measure outcomes in a meaningful way, the rate of hospital readmissions remains unacceptably high, according to an Emory University surgeon who has studied the readmission patterns.

“Readmission is a problem, not only from a cost and penalties standpoint but also from the rates of readmission affecting patients’ lives and expectations,” Jyotirmay Sharma, MD, said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

Dr. Jyotirmay Sharma

Dr. Sharma, director of thyroid and endocrine surgery at Emory University Hospital, Atlanta, cited recent federal data estimating that among Medicare patients discharged from a hospital, 20% are rehospitalized within 30 days, and 34% are rehospitalized within 90 days. In 2013 alone, the Centers for Medicare & Medicaid Services levied readmission penalties against 2,213 hospitals to the tune of $280 million. “So clearly it’s a major issue,” he said.

In a study conducted by one of Dr. Sharma’s associates, researchers evaluated the risk factors for 30-day hospital readmission among general surgery patients treated at Emory University Hospital (J Am Coll Surg. 2012 Sep;215[3]:322-30). Pancreatectomy accounted for 18% of readmissions, followed by colectomy/colostomy (13%), small bowel resection (12%), and gastrectomy and ventral hernia repair (both 11%).

An unrelated analysis of a 498,875 operations found that lower extremity vascular bypass procedures accounted for 16% of readmissions, followed by colectomy or proctectomy (11%), bariatric surgery (5%), and ventral hernia repair (4%). In addition, the readmission rates were 6% among patients with no complications, 16% among those with one complications such as surgical site infections (SSIs), bleeding, and ileus, 37% among those with two or more complications, and 29% among those with three or more complications (JAMA 2015;313[3]:483-95). The most common complication overall was SSI (20%), followed by ileus (10%).

When the Emory study researchers drilled down on their data, they found that the following preexisting conditions were associated with readmissions among colectomy patients: steroid use, hypertension, readmission, cancer, COPD, smoking, poor functional status, and diabetes. At the same time, preexisting conditions associated with readmissions among vascular patients were diabetes and renal failure. The only preexisting condition associated with readmissions among thyroidectomy was renal failure. When the researchers evaluated the association between readmission risk and system-wide complications, they found that vascular surgery and urinary surgery conferred the highest risks (sixfold and fivefold, respectively).

“Just looking at your semiannual report quickly can give you a sense of which complications are associated with that readmission,” Dr. Sharma said. “There are many areas of potential intervention.” Preoperatively, he recommends screening surgery patients for obstructive sleep apnea, hypertension, and diabetes. “Looking at preexisting comorbid dyspnea, cancer, and renal failure can give you those target populations very quickly,” he said.

Intraoperatively, “it’s all about reduction of complications,” he said. These include using the WHO checklist, employing SSI prevention practices and considering certain anesthesia techniques such as low tidal volume ventilation and fluid limitation, control of hyperglycemia, and enhanced recovery after surgery protocols (ERAS).

Postoperative strategies to reduce readmission risk include ERAS for multimodal analgesia, fluid restriction, oral intake, and ambulation, and being aggressive about follow-up with high-risk populations and discharge planning. “The strategies for readmission reduction should be based on the preoperative assessment and the ability to identify high-risk populations,” Dr. Sharma said. “At Emory, we found that ileostomy patients had the highest risk of readmission. This made sense from a dehydration standpoint. So a colorectal surgeon led the creation of an Emory-wide protocol for teaching patients and their families, giving them signs of dehydration, what to look for, direct access to a dedicated nurse for follow-up, and an arrangement with the infusion center for rehydration as needed.”

He concluded by noting that there is no one-size-fits-all approach to reducing hospital readmissions. “I think an overarching readmission improvement process is not the way to go, unless you’re talking about a preoperative assessment area,” he said. “Identifying high-risk patients and giving them a lifeline where they can call so you can intervene and avoid that readmission, is better.”

Dr. Sharma reported having no relevant disclosures.

[email protected]

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FDA updates warning label for systemic fluoroquinolones

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The Food and Drug Administration has amended the boxed warning on labels for fluoroquinolone antibiotics, taken either orally or by injection, to reflect recent findings of the drugs’ alarming potential adverse events.

“These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient,” the FDA stated in its Safety Announcement.

As a result, health care providers should reserve systemic fluoroquinolones for patients who have no other treatment options for any of the following conditions: acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTIs). The FDA also said that, for some serious bacterial infections, the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients taking fluoroquinolones must also be vigilant and let their provider know immediately if they begin suffering from any new pain in their joints, tendons, or muscles. Additionally, if patients begin feeling any numbness in their arms and legs, a prickling or “pins and needles” sensation, or confusion and hallucinations, they should contact their health care provider right away so that they may be switched onto a nonfluoroquinolone antibacterial drug for the remainder of their treatment regimen.

Avelox; Cipro, both standard and extended release; Factive; Levaquin; and ofloxacin are the fluoroquinolones currently approved by the FDA for systemic use. Their active ingredients are moxifloxacin, ciprofloxacin, gemifloxacin, levofloxacin, and ofloxacin, respectively.

Additional side effects for patients taking fluoroquinolones could include tendinitis, tendon rupture, and joint swelling. Central nervous system afflictions could include depression and thoughts of suicide. Fluoroquinolones could also bring about skin rashes, sunburn, arrhythmia, diarrhea, as well as aggravate myasthenia gravis in patients who suffer from it. Warnings regarding these conditions are already included on the drugs’ existing boxed warning.

“In addition to updating information in the Boxed Warning, we are also including information about these safety issues in the Warnings and Precautions section of the label,” the FDA stated. “The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for ABS, ABECB, and uncomplicated UTIs.”

The FDA also added that it will continue to monitor and assess safety issues associated with fluoroquinolones and will issue any further updates if necessary.

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The Food and Drug Administration has amended the boxed warning on labels for fluoroquinolone antibiotics, taken either orally or by injection, to reflect recent findings of the drugs’ alarming potential adverse events.

“These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient,” the FDA stated in its Safety Announcement.

As a result, health care providers should reserve systemic fluoroquinolones for patients who have no other treatment options for any of the following conditions: acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTIs). The FDA also said that, for some serious bacterial infections, the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients taking fluoroquinolones must also be vigilant and let their provider know immediately if they begin suffering from any new pain in their joints, tendons, or muscles. Additionally, if patients begin feeling any numbness in their arms and legs, a prickling or “pins and needles” sensation, or confusion and hallucinations, they should contact their health care provider right away so that they may be switched onto a nonfluoroquinolone antibacterial drug for the remainder of their treatment regimen.

Avelox; Cipro, both standard and extended release; Factive; Levaquin; and ofloxacin are the fluoroquinolones currently approved by the FDA for systemic use. Their active ingredients are moxifloxacin, ciprofloxacin, gemifloxacin, levofloxacin, and ofloxacin, respectively.

Additional side effects for patients taking fluoroquinolones could include tendinitis, tendon rupture, and joint swelling. Central nervous system afflictions could include depression and thoughts of suicide. Fluoroquinolones could also bring about skin rashes, sunburn, arrhythmia, diarrhea, as well as aggravate myasthenia gravis in patients who suffer from it. Warnings regarding these conditions are already included on the drugs’ existing boxed warning.

“In addition to updating information in the Boxed Warning, we are also including information about these safety issues in the Warnings and Precautions section of the label,” the FDA stated. “The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for ABS, ABECB, and uncomplicated UTIs.”

The FDA also added that it will continue to monitor and assess safety issues associated with fluoroquinolones and will issue any further updates if necessary.

[email protected]

The Food and Drug Administration has amended the boxed warning on labels for fluoroquinolone antibiotics, taken either orally or by injection, to reflect recent findings of the drugs’ alarming potential adverse events.

“These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient,” the FDA stated in its Safety Announcement.

As a result, health care providers should reserve systemic fluoroquinolones for patients who have no other treatment options for any of the following conditions: acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTIs). The FDA also said that, for some serious bacterial infections, the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients taking fluoroquinolones must also be vigilant and let their provider know immediately if they begin suffering from any new pain in their joints, tendons, or muscles. Additionally, if patients begin feeling any numbness in their arms and legs, a prickling or “pins and needles” sensation, or confusion and hallucinations, they should contact their health care provider right away so that they may be switched onto a nonfluoroquinolone antibacterial drug for the remainder of their treatment regimen.

Avelox; Cipro, both standard and extended release; Factive; Levaquin; and ofloxacin are the fluoroquinolones currently approved by the FDA for systemic use. Their active ingredients are moxifloxacin, ciprofloxacin, gemifloxacin, levofloxacin, and ofloxacin, respectively.

Additional side effects for patients taking fluoroquinolones could include tendinitis, tendon rupture, and joint swelling. Central nervous system afflictions could include depression and thoughts of suicide. Fluoroquinolones could also bring about skin rashes, sunburn, arrhythmia, diarrhea, as well as aggravate myasthenia gravis in patients who suffer from it. Warnings regarding these conditions are already included on the drugs’ existing boxed warning.

“In addition to updating information in the Boxed Warning, we are also including information about these safety issues in the Warnings and Precautions section of the label,” the FDA stated. “The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for ABS, ABECB, and uncomplicated UTIs.”

The FDA also added that it will continue to monitor and assess safety issues associated with fluoroquinolones and will issue any further updates if necessary.

[email protected]

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CMS proposes bundled payments for AMI, CABG

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The Centers for Medicare & Medicaid Services is proposing new bundled payment models for acute myocardial infarction and coronary artery bypass grafting, and a separate payment to incentivize the use of cardiac rehabilitation.

As part of the proposal, CMS also is developing a pathway that would allow the bundle to be recognized as an advanced alternative payment model under the Medicare Access and CHIP Reauthorization Act and qualify the physicians and clinicians being paid through the model for the 5% incentive payment.

Dr. Patrick Conway

The proposed bundled payment model would place patient care accountability for 90 days after discharge on the hospital where acute myocardial infarction care or coronary artery bypass grafting occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas would be placed under this model and monitored for a 5-year period to test whether the model leads to improved outcomes and generates cost savings.

The proposed rule can be seen here and an advanced notice is expected to be published on the Federal Register website on July 26. CMS will be accepting comments on the proposal for 60 days following official publication in the Federal Register.

“In 2014, more than 200,000 Medicare beneficiaries were hospitalized for heart attack treatment or underwent bypass surgery, costing Medicare over $6 billion. But the cost of treating patients varied by 50% across hospitals, and the share of patients readmitted to the hospitals within 30 days varied by more than 50%. And patient experience also varies,” CMS Acting Principal Deputy Administrator and Chief Medical Officer Patrick Conway, MD, said during a July 25 press teleconference introducing the proposal. “In some cases, hospitals, doctors, and rehabilitation facilities work together to support a patient from heart attack or surgery all the way through recovery. But in other cases, coordination breaks down, especially when a patient leaves the hospital. By structuring a payment around a patient’s total experience of care, bundled payments support better care coordination and ultimately better outcomes for patients.”

The hospital would be paid a fixed target price for each care episode, with hospitals delivering higher-quality care receiving a higher target price. The hospital would either keep the savings achieved or, if the costs exceeded the target pricing, have to repay Medicare the difference.

Target prices will be based on historical cost data beginning with hospitalization and extending out 90 days following discharge and adjusted based on the complexity of treatment required. For the 18 months of the program (July 1, 2017, through Dec. 31, 2018) target prices would be based on a blend of two-thirds participant-specific data and one-third regional data. In the third performance year (2019), the mix would move to one-third participant data and two-thirds regional data. Beginning in 2020, only regional data would be used to set target prices.

For heart attacks, the following quality measures are being proposed: Hospital 30-day, all-cause, risk-standardized mortality following acute myocardial infarction hospitalization; excess days in acute care after hospitalization for acute myocardial infarction; Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey scores; and voluntary hybrid hospital 30-day, all-cause, risk-standardized mortality eMeasure data submission.

For bypass surgery, the quality measures will be the hospital 30-day all-cause, risk-standardized mortality rate following coronary artery bypass graft; and HCAHPS survey scores.

“CMS’s evaluation ... will examine quality during the episode period, after the episode period ends, and for longer durations such as 1-year mortality rates,” the agency said in a fact sheet describing the proposal. “CMS will examine outcomes and patient experience measures such as mortality, readmissions, complications, and other clinically relevant outcomes.”

Separately, the agency is proposing to test a cardiac rehabilitation incentive payment. The two-part cardiac rehabilitation incentive payment would be paid retrospectively based on the total cardiac rehabilitation use of beneficiaries attributable to participant hospitals.

“Currently, only 15% of heart attack patients receive cardiac rehabilitation, even though completing a rehabilitation program can lower the risk of the second heart attack or death,” Dr. Conway said. “Patients who receive cardiac rehabilitation are assigned a team of health care professionals such as cardiologists, dietitians, and physical therapists who help the patient to recover and regain cardiovascular fitness.”

The initial payment would be $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare during the 90-day care period for a heart attack or bypass surgery. After 11 services, the payment would increase to $175 during the care period.

The number of sessions would be limited to two 1-hour sessions per day up to 36 sessions over up to 36 weeks, with the option for an additional 36 sessions over an extended period if approved by the local Medicare contractor. Intensive cardiac rehabilitation program sessions would be limited to 72 1-hour sessions, up to six sessions per day, over 18 weeks.

 

 

While officials from the American College of Cardiology said that the organization supports the concepts of value-based care, “it is important that bundled care models be carried out in such a way that clinicians are given the time and tools to truly impact patient care in the best ways possible. Changes in payment structures in health care can pose significant challenges to clinicians and must be driven by clinical practices that improve patient outcomes,” ACC  President Richard A. Chazal, MD, said in a statement. “We are optimistic that CMS will listen to comments, incorporate feedback from clinicians, and provide ample time for implementation of these new payment models. Our ultimate goal is to improve patient care and to improve heart health.”

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The Centers for Medicare & Medicaid Services is proposing new bundled payment models for acute myocardial infarction and coronary artery bypass grafting, and a separate payment to incentivize the use of cardiac rehabilitation.

As part of the proposal, CMS also is developing a pathway that would allow the bundle to be recognized as an advanced alternative payment model under the Medicare Access and CHIP Reauthorization Act and qualify the physicians and clinicians being paid through the model for the 5% incentive payment.

Dr. Patrick Conway

The proposed bundled payment model would place patient care accountability for 90 days after discharge on the hospital where acute myocardial infarction care or coronary artery bypass grafting occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas would be placed under this model and monitored for a 5-year period to test whether the model leads to improved outcomes and generates cost savings.

The proposed rule can be seen here and an advanced notice is expected to be published on the Federal Register website on July 26. CMS will be accepting comments on the proposal for 60 days following official publication in the Federal Register.

“In 2014, more than 200,000 Medicare beneficiaries were hospitalized for heart attack treatment or underwent bypass surgery, costing Medicare over $6 billion. But the cost of treating patients varied by 50% across hospitals, and the share of patients readmitted to the hospitals within 30 days varied by more than 50%. And patient experience also varies,” CMS Acting Principal Deputy Administrator and Chief Medical Officer Patrick Conway, MD, said during a July 25 press teleconference introducing the proposal. “In some cases, hospitals, doctors, and rehabilitation facilities work together to support a patient from heart attack or surgery all the way through recovery. But in other cases, coordination breaks down, especially when a patient leaves the hospital. By structuring a payment around a patient’s total experience of care, bundled payments support better care coordination and ultimately better outcomes for patients.”

The hospital would be paid a fixed target price for each care episode, with hospitals delivering higher-quality care receiving a higher target price. The hospital would either keep the savings achieved or, if the costs exceeded the target pricing, have to repay Medicare the difference.

Target prices will be based on historical cost data beginning with hospitalization and extending out 90 days following discharge and adjusted based on the complexity of treatment required. For the 18 months of the program (July 1, 2017, through Dec. 31, 2018) target prices would be based on a blend of two-thirds participant-specific data and one-third regional data. In the third performance year (2019), the mix would move to one-third participant data and two-thirds regional data. Beginning in 2020, only regional data would be used to set target prices.

For heart attacks, the following quality measures are being proposed: Hospital 30-day, all-cause, risk-standardized mortality following acute myocardial infarction hospitalization; excess days in acute care after hospitalization for acute myocardial infarction; Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey scores; and voluntary hybrid hospital 30-day, all-cause, risk-standardized mortality eMeasure data submission.

For bypass surgery, the quality measures will be the hospital 30-day all-cause, risk-standardized mortality rate following coronary artery bypass graft; and HCAHPS survey scores.

“CMS’s evaluation ... will examine quality during the episode period, after the episode period ends, and for longer durations such as 1-year mortality rates,” the agency said in a fact sheet describing the proposal. “CMS will examine outcomes and patient experience measures such as mortality, readmissions, complications, and other clinically relevant outcomes.”

Separately, the agency is proposing to test a cardiac rehabilitation incentive payment. The two-part cardiac rehabilitation incentive payment would be paid retrospectively based on the total cardiac rehabilitation use of beneficiaries attributable to participant hospitals.

“Currently, only 15% of heart attack patients receive cardiac rehabilitation, even though completing a rehabilitation program can lower the risk of the second heart attack or death,” Dr. Conway said. “Patients who receive cardiac rehabilitation are assigned a team of health care professionals such as cardiologists, dietitians, and physical therapists who help the patient to recover and regain cardiovascular fitness.”

The initial payment would be $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare during the 90-day care period for a heart attack or bypass surgery. After 11 services, the payment would increase to $175 during the care period.

The number of sessions would be limited to two 1-hour sessions per day up to 36 sessions over up to 36 weeks, with the option for an additional 36 sessions over an extended period if approved by the local Medicare contractor. Intensive cardiac rehabilitation program sessions would be limited to 72 1-hour sessions, up to six sessions per day, over 18 weeks.

 

 

While officials from the American College of Cardiology said that the organization supports the concepts of value-based care, “it is important that bundled care models be carried out in such a way that clinicians are given the time and tools to truly impact patient care in the best ways possible. Changes in payment structures in health care can pose significant challenges to clinicians and must be driven by clinical practices that improve patient outcomes,” ACC  President Richard A. Chazal, MD, said in a statement. “We are optimistic that CMS will listen to comments, incorporate feedback from clinicians, and provide ample time for implementation of these new payment models. Our ultimate goal is to improve patient care and to improve heart health.”

[email protected]

The Centers for Medicare & Medicaid Services is proposing new bundled payment models for acute myocardial infarction and coronary artery bypass grafting, and a separate payment to incentivize the use of cardiac rehabilitation.

As part of the proposal, CMS also is developing a pathway that would allow the bundle to be recognized as an advanced alternative payment model under the Medicare Access and CHIP Reauthorization Act and qualify the physicians and clinicians being paid through the model for the 5% incentive payment.

Dr. Patrick Conway

The proposed bundled payment model would place patient care accountability for 90 days after discharge on the hospital where acute myocardial infarction care or coronary artery bypass grafting occurred. Beginning July 1, 2017, hospitals in 98 randomly selected metropolitan statistical areas would be placed under this model and monitored for a 5-year period to test whether the model leads to improved outcomes and generates cost savings.

The proposed rule can be seen here and an advanced notice is expected to be published on the Federal Register website on July 26. CMS will be accepting comments on the proposal for 60 days following official publication in the Federal Register.

“In 2014, more than 200,000 Medicare beneficiaries were hospitalized for heart attack treatment or underwent bypass surgery, costing Medicare over $6 billion. But the cost of treating patients varied by 50% across hospitals, and the share of patients readmitted to the hospitals within 30 days varied by more than 50%. And patient experience also varies,” CMS Acting Principal Deputy Administrator and Chief Medical Officer Patrick Conway, MD, said during a July 25 press teleconference introducing the proposal. “In some cases, hospitals, doctors, and rehabilitation facilities work together to support a patient from heart attack or surgery all the way through recovery. But in other cases, coordination breaks down, especially when a patient leaves the hospital. By structuring a payment around a patient’s total experience of care, bundled payments support better care coordination and ultimately better outcomes for patients.”

The hospital would be paid a fixed target price for each care episode, with hospitals delivering higher-quality care receiving a higher target price. The hospital would either keep the savings achieved or, if the costs exceeded the target pricing, have to repay Medicare the difference.

Target prices will be based on historical cost data beginning with hospitalization and extending out 90 days following discharge and adjusted based on the complexity of treatment required. For the 18 months of the program (July 1, 2017, through Dec. 31, 2018) target prices would be based on a blend of two-thirds participant-specific data and one-third regional data. In the third performance year (2019), the mix would move to one-third participant data and two-thirds regional data. Beginning in 2020, only regional data would be used to set target prices.

For heart attacks, the following quality measures are being proposed: Hospital 30-day, all-cause, risk-standardized mortality following acute myocardial infarction hospitalization; excess days in acute care after hospitalization for acute myocardial infarction; Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey scores; and voluntary hybrid hospital 30-day, all-cause, risk-standardized mortality eMeasure data submission.

For bypass surgery, the quality measures will be the hospital 30-day all-cause, risk-standardized mortality rate following coronary artery bypass graft; and HCAHPS survey scores.

“CMS’s evaluation ... will examine quality during the episode period, after the episode period ends, and for longer durations such as 1-year mortality rates,” the agency said in a fact sheet describing the proposal. “CMS will examine outcomes and patient experience measures such as mortality, readmissions, complications, and other clinically relevant outcomes.”

Separately, the agency is proposing to test a cardiac rehabilitation incentive payment. The two-part cardiac rehabilitation incentive payment would be paid retrospectively based on the total cardiac rehabilitation use of beneficiaries attributable to participant hospitals.

“Currently, only 15% of heart attack patients receive cardiac rehabilitation, even though completing a rehabilitation program can lower the risk of the second heart attack or death,” Dr. Conway said. “Patients who receive cardiac rehabilitation are assigned a team of health care professionals such as cardiologists, dietitians, and physical therapists who help the patient to recover and regain cardiovascular fitness.”

The initial payment would be $25 per cardiac rehabilitation service for each of the first 11 services paid for by Medicare during the 90-day care period for a heart attack or bypass surgery. After 11 services, the payment would increase to $175 during the care period.

The number of sessions would be limited to two 1-hour sessions per day up to 36 sessions over up to 36 weeks, with the option for an additional 36 sessions over an extended period if approved by the local Medicare contractor. Intensive cardiac rehabilitation program sessions would be limited to 72 1-hour sessions, up to six sessions per day, over 18 weeks.

 

 

While officials from the American College of Cardiology said that the organization supports the concepts of value-based care, “it is important that bundled care models be carried out in such a way that clinicians are given the time and tools to truly impact patient care in the best ways possible. Changes in payment structures in health care can pose significant challenges to clinicians and must be driven by clinical practices that improve patient outcomes,” ACC  President Richard A. Chazal, MD, said in a statement. “We are optimistic that CMS will listen to comments, incorporate feedback from clinicians, and provide ample time for implementation of these new payment models. Our ultimate goal is to improve patient care and to improve heart health.”

[email protected]

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The drive to cut readmissions after bariatric surgery continues with DROP project

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SAN DIEGO – John Morton, MD, started his bariatric surgery career about the same time that demand for gastric bypass and other bariatric procedures began to skyrocket. But a troubling trend emerged.

“About 10-15 years ago, bariatric surgery had a problem when it came to mortality,” Dr. Morton said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. “You can’t move forward without looking back.”

Whitney McKnight/Frontline Medical News
Dr. John Morton

A 2005 study of early mortality among Medicare beneficiaries undergoing bariatric procedures found a 30-day mortality of 9% and a 1-year mortality of 21% (JAMA 2005 Oct. 19;294[15]:1903-8). Such data prompted Dr. Morton and other leaders in the field to push for accreditation in the field. In 2012, the ACS Bariatric Surgery Center Network program and the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Centers of Excellence program were extended accreditation in the joint Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). As a result, the mortality rate among patients undergoing bariatric procedures has dropped nearly 10-fold and now stands at 1 out of 1,000, said Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. “That’s been a real success story for us,” he said. “Part of it has been the accreditation program, having the resources in place to accomplish those goals.”

Of the 802 participating centers in MBSAQIP, 647 are accredited. “One of the reasons we see such good results at accredited centers is the fact that they work as a multidisciplinary team, where you have the nutritionist, the psychologist, the internist, and the anesthesiologist working together,” said Dr. Morton, immediate past president of the American Society for Metabolic and Bariatric Surgery. “When you have that team, it allows you to marshal your resources, do appropriate risk assessment, and get those processes in place to have the very best outcomes.”

In an effort to reduce hospital readmissions among bariatric surgery patients, MBSAQIP launched a national project called Decreasing Readmissions through Opportunities Provided (DROP), which currently has 129 participating hospitals. “If you drill down on the reasons for bariatric surgery readmissions, many are preventable: dehydration, nausea, medication side effects, and patient expectations,” Dr. Morton said. “I have a formula called the Morton Formula: happiness equals reality divided by expectations. If you set expectations accordingly, you’ll get a happier patient. If my patients know they’re going to be discharged in 1 day, they can plan accordingly.”

These concepts were adopted from a study that Dr. Morton and his associates carried out at Stanford Health Care in an effort to reduce readmissions for complications within 30 days to below the national average. It involved “straightforward” strategy including improving patient education, discharge planning, and giving patients a direct phone number to call. “Anybody who has called a health center and has had to go through that phone tree knows how difficult that can be, so we provide a direct number,” he said. “The postop phone call is critical, because that’s a way to nip readmissions in the bud. We do same-day appointments so they come and see us in the clinic rather than going to the ER and getting the enormous workup. Infusion centers are our best friend, because many of these patients come in dehydrated.”

After implementing these strategies, the rate of readmission for complications at Stanford fell from 8% to 2.5%. This led to the creation of a readmission bundle for the DROP project with steps for preoperative, intraoperative, and postoperative aspects of care. For example, preoperatively, “we make sure that they have a postop appointment made [and] rather than waiting to give them a prescription when they get discharged, we make sure that they have those prescriptions earlier at the preoperative visit,” he said. “They are provided the clinic phone number and patients watch video vignettes from all members of the team: surgeon, nurse, nutritionist, pharmacist, and psychologist. Rather than the education being dependent on [the surgeon’s schedule], they can get the same dose of education and even watch these over and over again if they want to.”

Surgeons who participate in the DROP project also stratify high-risk patients by consulting with their primary care physicians and case managers to achieve optimal outcomes. They address modifiable risk factors. “Weight gain prior to bariatric surgery is not ideal, so we want to address that, and have a hemoglobin A1c of less than 10%,” Dr. Morton said. Patients receive a “HELP” card, which instructs them to contact the treating clinic if they have abdominal pain, dehydration, nausea and vomiting, diarrhea, and fatigue.

 

 

The inpatient part of the bundle includes a “clinical roadmap” with a fixed length of stay. “There are expectations every single day about what’s going to happen to their care,” Dr. Morton said. “We give them a water bottle with the logo of the hospital. It’s a reminder for them to stay hydrated. They have a nutritional consult and they go through a checklist before they get discharged.”

The postoperative component of the DROP bundle includes a phone call to the patient following discharge. “They also get an appointment with a nutritionist within a month of surgery,” he said. “We treat readmissions seriously, like a complication.”

Data from a study of 18,296 primary bariatric surgery patients gleaned from 2012 ACS-NSQIP Participant Use Data Files found a 30-day readmission rate of 5.2% (Am J Surg 2016 Jul;212[1]:76-80). Compared with the patients’ counterparts who did not require readmission within 30 days, risk factors for those who did included body mass index greater than 50 kg/m2 (30.2% vs. 24.6%, respectively; P = .001); longer operative time (132 vs. 115 minutes; P = .001); length of stay greater than 4 days (9.57% vs. 3.36%; P = .001); surgical site infection (15.5% vs. 1.15%; P less than .001); urinary tract infection (3.15% vs. .65%; P less than .001), and deep vein thrombosis (3.58% vs. .13%; P less than .001). Common reasons for readmissions were GI-related (45%), dietary (33.5%), and bleeding (6.57%). Dr. Morton went on to report preliminary findings from 19,648 cases included in the DROP project, which began collecting data in March 2015 and has a yearlong goal of reducing national admission rates by 20%. The preintervention readmission rate was 4.79%. By the end of October 2015 the readmission rate had dropped to 4.30%. “One of the things we realized is that the hospitals with the higher readmission rates were the ones who had the greatest improvement,” Dr. Morton said. “They went from about 8% down to about 5.51%. We anticipate that for each quarter that we do this, we’ll continue to see improvement.”

Individual center results were made available in late January 2016 and reviewed with mentors. “They also received aggregated reports to see how they stacked up others as a benchmark,” Dr. Morton said.

Final results from DROP are expected to be released later in 2016.

Dr. Morton reported having no financial disclosures.

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SAN DIEGO – John Morton, MD, started his bariatric surgery career about the same time that demand for gastric bypass and other bariatric procedures began to skyrocket. But a troubling trend emerged.

“About 10-15 years ago, bariatric surgery had a problem when it came to mortality,” Dr. Morton said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. “You can’t move forward without looking back.”

Whitney McKnight/Frontline Medical News
Dr. John Morton

A 2005 study of early mortality among Medicare beneficiaries undergoing bariatric procedures found a 30-day mortality of 9% and a 1-year mortality of 21% (JAMA 2005 Oct. 19;294[15]:1903-8). Such data prompted Dr. Morton and other leaders in the field to push for accreditation in the field. In 2012, the ACS Bariatric Surgery Center Network program and the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Centers of Excellence program were extended accreditation in the joint Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). As a result, the mortality rate among patients undergoing bariatric procedures has dropped nearly 10-fold and now stands at 1 out of 1,000, said Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. “That’s been a real success story for us,” he said. “Part of it has been the accreditation program, having the resources in place to accomplish those goals.”

Of the 802 participating centers in MBSAQIP, 647 are accredited. “One of the reasons we see such good results at accredited centers is the fact that they work as a multidisciplinary team, where you have the nutritionist, the psychologist, the internist, and the anesthesiologist working together,” said Dr. Morton, immediate past president of the American Society for Metabolic and Bariatric Surgery. “When you have that team, it allows you to marshal your resources, do appropriate risk assessment, and get those processes in place to have the very best outcomes.”

In an effort to reduce hospital readmissions among bariatric surgery patients, MBSAQIP launched a national project called Decreasing Readmissions through Opportunities Provided (DROP), which currently has 129 participating hospitals. “If you drill down on the reasons for bariatric surgery readmissions, many are preventable: dehydration, nausea, medication side effects, and patient expectations,” Dr. Morton said. “I have a formula called the Morton Formula: happiness equals reality divided by expectations. If you set expectations accordingly, you’ll get a happier patient. If my patients know they’re going to be discharged in 1 day, they can plan accordingly.”

These concepts were adopted from a study that Dr. Morton and his associates carried out at Stanford Health Care in an effort to reduce readmissions for complications within 30 days to below the national average. It involved “straightforward” strategy including improving patient education, discharge planning, and giving patients a direct phone number to call. “Anybody who has called a health center and has had to go through that phone tree knows how difficult that can be, so we provide a direct number,” he said. “The postop phone call is critical, because that’s a way to nip readmissions in the bud. We do same-day appointments so they come and see us in the clinic rather than going to the ER and getting the enormous workup. Infusion centers are our best friend, because many of these patients come in dehydrated.”

After implementing these strategies, the rate of readmission for complications at Stanford fell from 8% to 2.5%. This led to the creation of a readmission bundle for the DROP project with steps for preoperative, intraoperative, and postoperative aspects of care. For example, preoperatively, “we make sure that they have a postop appointment made [and] rather than waiting to give them a prescription when they get discharged, we make sure that they have those prescriptions earlier at the preoperative visit,” he said. “They are provided the clinic phone number and patients watch video vignettes from all members of the team: surgeon, nurse, nutritionist, pharmacist, and psychologist. Rather than the education being dependent on [the surgeon’s schedule], they can get the same dose of education and even watch these over and over again if they want to.”

Surgeons who participate in the DROP project also stratify high-risk patients by consulting with their primary care physicians and case managers to achieve optimal outcomes. They address modifiable risk factors. “Weight gain prior to bariatric surgery is not ideal, so we want to address that, and have a hemoglobin A1c of less than 10%,” Dr. Morton said. Patients receive a “HELP” card, which instructs them to contact the treating clinic if they have abdominal pain, dehydration, nausea and vomiting, diarrhea, and fatigue.

 

 

The inpatient part of the bundle includes a “clinical roadmap” with a fixed length of stay. “There are expectations every single day about what’s going to happen to their care,” Dr. Morton said. “We give them a water bottle with the logo of the hospital. It’s a reminder for them to stay hydrated. They have a nutritional consult and they go through a checklist before they get discharged.”

The postoperative component of the DROP bundle includes a phone call to the patient following discharge. “They also get an appointment with a nutritionist within a month of surgery,” he said. “We treat readmissions seriously, like a complication.”

Data from a study of 18,296 primary bariatric surgery patients gleaned from 2012 ACS-NSQIP Participant Use Data Files found a 30-day readmission rate of 5.2% (Am J Surg 2016 Jul;212[1]:76-80). Compared with the patients’ counterparts who did not require readmission within 30 days, risk factors for those who did included body mass index greater than 50 kg/m2 (30.2% vs. 24.6%, respectively; P = .001); longer operative time (132 vs. 115 minutes; P = .001); length of stay greater than 4 days (9.57% vs. 3.36%; P = .001); surgical site infection (15.5% vs. 1.15%; P less than .001); urinary tract infection (3.15% vs. .65%; P less than .001), and deep vein thrombosis (3.58% vs. .13%; P less than .001). Common reasons for readmissions were GI-related (45%), dietary (33.5%), and bleeding (6.57%). Dr. Morton went on to report preliminary findings from 19,648 cases included in the DROP project, which began collecting data in March 2015 and has a yearlong goal of reducing national admission rates by 20%. The preintervention readmission rate was 4.79%. By the end of October 2015 the readmission rate had dropped to 4.30%. “One of the things we realized is that the hospitals with the higher readmission rates were the ones who had the greatest improvement,” Dr. Morton said. “They went from about 8% down to about 5.51%. We anticipate that for each quarter that we do this, we’ll continue to see improvement.”

Individual center results were made available in late January 2016 and reviewed with mentors. “They also received aggregated reports to see how they stacked up others as a benchmark,” Dr. Morton said.

Final results from DROP are expected to be released later in 2016.

Dr. Morton reported having no financial disclosures.

[email protected]

SAN DIEGO – John Morton, MD, started his bariatric surgery career about the same time that demand for gastric bypass and other bariatric procedures began to skyrocket. But a troubling trend emerged.

“About 10-15 years ago, bariatric surgery had a problem when it came to mortality,” Dr. Morton said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. “You can’t move forward without looking back.”

Whitney McKnight/Frontline Medical News
Dr. John Morton

A 2005 study of early mortality among Medicare beneficiaries undergoing bariatric procedures found a 30-day mortality of 9% and a 1-year mortality of 21% (JAMA 2005 Oct. 19;294[15]:1903-8). Such data prompted Dr. Morton and other leaders in the field to push for accreditation in the field. In 2012, the ACS Bariatric Surgery Center Network program and the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Centers of Excellence program were extended accreditation in the joint Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). As a result, the mortality rate among patients undergoing bariatric procedures has dropped nearly 10-fold and now stands at 1 out of 1,000, said Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University. “That’s been a real success story for us,” he said. “Part of it has been the accreditation program, having the resources in place to accomplish those goals.”

Of the 802 participating centers in MBSAQIP, 647 are accredited. “One of the reasons we see such good results at accredited centers is the fact that they work as a multidisciplinary team, where you have the nutritionist, the psychologist, the internist, and the anesthesiologist working together,” said Dr. Morton, immediate past president of the American Society for Metabolic and Bariatric Surgery. “When you have that team, it allows you to marshal your resources, do appropriate risk assessment, and get those processes in place to have the very best outcomes.”

In an effort to reduce hospital readmissions among bariatric surgery patients, MBSAQIP launched a national project called Decreasing Readmissions through Opportunities Provided (DROP), which currently has 129 participating hospitals. “If you drill down on the reasons for bariatric surgery readmissions, many are preventable: dehydration, nausea, medication side effects, and patient expectations,” Dr. Morton said. “I have a formula called the Morton Formula: happiness equals reality divided by expectations. If you set expectations accordingly, you’ll get a happier patient. If my patients know they’re going to be discharged in 1 day, they can plan accordingly.”

These concepts were adopted from a study that Dr. Morton and his associates carried out at Stanford Health Care in an effort to reduce readmissions for complications within 30 days to below the national average. It involved “straightforward” strategy including improving patient education, discharge planning, and giving patients a direct phone number to call. “Anybody who has called a health center and has had to go through that phone tree knows how difficult that can be, so we provide a direct number,” he said. “The postop phone call is critical, because that’s a way to nip readmissions in the bud. We do same-day appointments so they come and see us in the clinic rather than going to the ER and getting the enormous workup. Infusion centers are our best friend, because many of these patients come in dehydrated.”

After implementing these strategies, the rate of readmission for complications at Stanford fell from 8% to 2.5%. This led to the creation of a readmission bundle for the DROP project with steps for preoperative, intraoperative, and postoperative aspects of care. For example, preoperatively, “we make sure that they have a postop appointment made [and] rather than waiting to give them a prescription when they get discharged, we make sure that they have those prescriptions earlier at the preoperative visit,” he said. “They are provided the clinic phone number and patients watch video vignettes from all members of the team: surgeon, nurse, nutritionist, pharmacist, and psychologist. Rather than the education being dependent on [the surgeon’s schedule], they can get the same dose of education and even watch these over and over again if they want to.”

Surgeons who participate in the DROP project also stratify high-risk patients by consulting with their primary care physicians and case managers to achieve optimal outcomes. They address modifiable risk factors. “Weight gain prior to bariatric surgery is not ideal, so we want to address that, and have a hemoglobin A1c of less than 10%,” Dr. Morton said. Patients receive a “HELP” card, which instructs them to contact the treating clinic if they have abdominal pain, dehydration, nausea and vomiting, diarrhea, and fatigue.

 

 

The inpatient part of the bundle includes a “clinical roadmap” with a fixed length of stay. “There are expectations every single day about what’s going to happen to their care,” Dr. Morton said. “We give them a water bottle with the logo of the hospital. It’s a reminder for them to stay hydrated. They have a nutritional consult and they go through a checklist before they get discharged.”

The postoperative component of the DROP bundle includes a phone call to the patient following discharge. “They also get an appointment with a nutritionist within a month of surgery,” he said. “We treat readmissions seriously, like a complication.”

Data from a study of 18,296 primary bariatric surgery patients gleaned from 2012 ACS-NSQIP Participant Use Data Files found a 30-day readmission rate of 5.2% (Am J Surg 2016 Jul;212[1]:76-80). Compared with the patients’ counterparts who did not require readmission within 30 days, risk factors for those who did included body mass index greater than 50 kg/m2 (30.2% vs. 24.6%, respectively; P = .001); longer operative time (132 vs. 115 minutes; P = .001); length of stay greater than 4 days (9.57% vs. 3.36%; P = .001); surgical site infection (15.5% vs. 1.15%; P less than .001); urinary tract infection (3.15% vs. .65%; P less than .001), and deep vein thrombosis (3.58% vs. .13%; P less than .001). Common reasons for readmissions were GI-related (45%), dietary (33.5%), and bleeding (6.57%). Dr. Morton went on to report preliminary findings from 19,648 cases included in the DROP project, which began collecting data in March 2015 and has a yearlong goal of reducing national admission rates by 20%. The preintervention readmission rate was 4.79%. By the end of October 2015 the readmission rate had dropped to 4.30%. “One of the things we realized is that the hospitals with the higher readmission rates were the ones who had the greatest improvement,” Dr. Morton said. “They went from about 8% down to about 5.51%. We anticipate that for each quarter that we do this, we’ll continue to see improvement.”

Individual center results were made available in late January 2016 and reviewed with mentors. “They also received aggregated reports to see how they stacked up others as a benchmark,” Dr. Morton said.

Final results from DROP are expected to be released later in 2016.

Dr. Morton reported having no financial disclosures.

[email protected]

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Blood management strategy leads to cost savings, less waste

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SAN DIEGO – A process intended to optimize blood management led to a 30% reduction in blood use and a savings of $2 million, results from a single-center study showed.

“Blood is a limited resource and we have a responsibility as a health care provider to optimize the use of a resource that is difficult to get and only available through altruistic donations,” lead study author Barbara J. Martin, RN, said in a press release. The study was presented in a poster session at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

ksena32/ThinkStock

In an effort to evaluate how they could implement evidence-based guidelines around restrictive transfusion, Ms. Martin and her colleagues at Vanderbilt University Medical Center, Nashville, Tenn., first changed provider orders to support a single unit order and then follow-up order for more blood if necessary. The previous process was to order two units of blood, which was at times more blood than was needed. “The data on restrictive transfusion has been out for years documenting that patients have better outcomes with a more restrictive transfusion strategy,” Ms. Martin, of the Vanderbilt Center for Clinical Improvement, said in the press release. “We were looking at whether we could guide providers to treat symptomatic anemia with a single unit of blood rather than the usual two units.”

The researchers enhanced the Computerized Provider Order Entry (CPOE) system to allow blood ordering practices to be based on a specific assessment of each case rather than on a standard order of two units. As a result, red blood cell transfusions at Vanderbilt declined from 675 units per 1,000 discharges in 2011 to 432 units per 1,000 discharges in 2015, a decrease of more than 30%.

In an effort to reduce inefficiencies in the way blood is ordered, transported, and stored, Ms. Martin and her multidisciplinary team developed the following guidelines for perioperative handling:

• When more than one unit of blood is ordered, it is sent in a cooler rather than the pneumatic tube.

• Coolers are reconfigured to optimize temperature management.

• A specific staff member is tasked with “ownership” of the blood products, including returning unused product to the blood bank.

• Individual unit wastage is reported to clinical leaders for review; aggregate data are reported monthly.

After implementation of these practices, fewer than 80 units of blood were wasted at Vanderbilt in 2015, a drop from 300 in 2011. Collectively, the blood management strategies resulted in a savings of $2 million. Ms. Martin said that such guidelines can be implemented at other medical centers, but “you have to prioritize what your initiatives are. At Vanderbilt we had a lot of opportunities with blood transfusion and blood wastage and we made huge gains. Any incremental improvement would take additional resources.”

The researchers reported having no relevant disclosures.

[email protected]

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SAN DIEGO – A process intended to optimize blood management led to a 30% reduction in blood use and a savings of $2 million, results from a single-center study showed.

“Blood is a limited resource and we have a responsibility as a health care provider to optimize the use of a resource that is difficult to get and only available through altruistic donations,” lead study author Barbara J. Martin, RN, said in a press release. The study was presented in a poster session at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

ksena32/ThinkStock

In an effort to evaluate how they could implement evidence-based guidelines around restrictive transfusion, Ms. Martin and her colleagues at Vanderbilt University Medical Center, Nashville, Tenn., first changed provider orders to support a single unit order and then follow-up order for more blood if necessary. The previous process was to order two units of blood, which was at times more blood than was needed. “The data on restrictive transfusion has been out for years documenting that patients have better outcomes with a more restrictive transfusion strategy,” Ms. Martin, of the Vanderbilt Center for Clinical Improvement, said in the press release. “We were looking at whether we could guide providers to treat symptomatic anemia with a single unit of blood rather than the usual two units.”

The researchers enhanced the Computerized Provider Order Entry (CPOE) system to allow blood ordering practices to be based on a specific assessment of each case rather than on a standard order of two units. As a result, red blood cell transfusions at Vanderbilt declined from 675 units per 1,000 discharges in 2011 to 432 units per 1,000 discharges in 2015, a decrease of more than 30%.

In an effort to reduce inefficiencies in the way blood is ordered, transported, and stored, Ms. Martin and her multidisciplinary team developed the following guidelines for perioperative handling:

• When more than one unit of blood is ordered, it is sent in a cooler rather than the pneumatic tube.

• Coolers are reconfigured to optimize temperature management.

• A specific staff member is tasked with “ownership” of the blood products, including returning unused product to the blood bank.

• Individual unit wastage is reported to clinical leaders for review; aggregate data are reported monthly.

After implementation of these practices, fewer than 80 units of blood were wasted at Vanderbilt in 2015, a drop from 300 in 2011. Collectively, the blood management strategies resulted in a savings of $2 million. Ms. Martin said that such guidelines can be implemented at other medical centers, but “you have to prioritize what your initiatives are. At Vanderbilt we had a lot of opportunities with blood transfusion and blood wastage and we made huge gains. Any incremental improvement would take additional resources.”

The researchers reported having no relevant disclosures.

[email protected]

SAN DIEGO – A process intended to optimize blood management led to a 30% reduction in blood use and a savings of $2 million, results from a single-center study showed.

“Blood is a limited resource and we have a responsibility as a health care provider to optimize the use of a resource that is difficult to get and only available through altruistic donations,” lead study author Barbara J. Martin, RN, said in a press release. The study was presented in a poster session at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

ksena32/ThinkStock

In an effort to evaluate how they could implement evidence-based guidelines around restrictive transfusion, Ms. Martin and her colleagues at Vanderbilt University Medical Center, Nashville, Tenn., first changed provider orders to support a single unit order and then follow-up order for more blood if necessary. The previous process was to order two units of blood, which was at times more blood than was needed. “The data on restrictive transfusion has been out for years documenting that patients have better outcomes with a more restrictive transfusion strategy,” Ms. Martin, of the Vanderbilt Center for Clinical Improvement, said in the press release. “We were looking at whether we could guide providers to treat symptomatic anemia with a single unit of blood rather than the usual two units.”

The researchers enhanced the Computerized Provider Order Entry (CPOE) system to allow blood ordering practices to be based on a specific assessment of each case rather than on a standard order of two units. As a result, red blood cell transfusions at Vanderbilt declined from 675 units per 1,000 discharges in 2011 to 432 units per 1,000 discharges in 2015, a decrease of more than 30%.

In an effort to reduce inefficiencies in the way blood is ordered, transported, and stored, Ms. Martin and her multidisciplinary team developed the following guidelines for perioperative handling:

• When more than one unit of blood is ordered, it is sent in a cooler rather than the pneumatic tube.

• Coolers are reconfigured to optimize temperature management.

• A specific staff member is tasked with “ownership” of the blood products, including returning unused product to the blood bank.

• Individual unit wastage is reported to clinical leaders for review; aggregate data are reported monthly.

After implementation of these practices, fewer than 80 units of blood were wasted at Vanderbilt in 2015, a drop from 300 in 2011. Collectively, the blood management strategies resulted in a savings of $2 million. Ms. Martin said that such guidelines can be implemented at other medical centers, but “you have to prioritize what your initiatives are. At Vanderbilt we had a lot of opportunities with blood transfusion and blood wastage and we made huge gains. Any incremental improvement would take additional resources.”

The researchers reported having no relevant disclosures.

[email protected]

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Key clinical point: A multidisciplinary effort to improve the process of blood product management led to a significantly reduced use of blood products.

Major finding: Red blood cell transfusions declined from 675 units per 1,000 discharges in 2011 to 432 units per 1,000 discharges in 2015, a decrease of more than 30%.

Data source: An alteration of the Computerized Provider Order Entry (CPOE) system at Vanderbilt University Medical Center to allow blood ordering practices to be based on a specific assessment of each case rather than on a standard order of two units.

Disclosures: The researchers reported having no financial disclosures.