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Patients and Surgeons Diverge on Disclosures

A total of 63% of patients thought it essential to know the number of times a surgeon had performed a particular procedure.
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Patients and Surgeons Diverge on Disclosures

SAN FRANCISCO – Recent surveys of patients and attending surgeons show differing views on disclosures, Dr. Susan Lee Char said at the clinical congress of the American College of Surgeons.

She and her associates surveyed 353 adult patients at their first postoperative clinic visit and 85 attending surgeons at hospitals affiliated with the University of California, San Francisco. The survey presented a hypothetical case of a patient’s undergoing elective partial hepatectomy and asked respondents to rate the importance of receiving or conveying various items of information on a 6-point Likert scale.

In all, 79% of patients said it’s essential to know if their surgeon would be doing a procedure for the first time on them, but only 55% of attending surgeons felt this was important information to disclose. A total of 63% of patients considered it essential to know the number of times a surgeon had performed a particular procedure and the outcomes in those cases, compared with just 25% and 20% of surgeons, respectively.

"The data suggest that surgeons do have an ethical obligation to disclose volumes and outcomes and if it’s the first time [they’re] doing a procedure," said Dr. Char, a surgical resident at the university who is also a lawyer. "This has possible legal implications."

The main barrier to surgeons’ disclosure may be a practical one, she added. Surgeons often don’t have data on the volumes and outcomes of their procedures.

Patients’ and attending surgeons’ perceptions of the importance of other types of information also differed significantly. A general description of the procedure was rated as important by 65% of patients vs. 58% of surgeons, and technical details of the procedure were important to 48% of patients and 13% of surgeons. Disclosure of risks and benefits of the procedure were deemed essential by 77% and 71% of patients, respectively, compared with 72% and 65% of surgeons, respectively. A total of 41% of patients and 5% of surgeons said the patient should be told the number of times the procedure has been done by other surgeons, and 44% of patients and 20% of surgeons said other surgeons’ outcomes should be disclosed.

A total of 64% of patients and 31% of surgeons believed it was important to discuss any special training by the surgeon doing the procedure. Some 64% of patients said they would want to be informed about the surgeon’s special training for a standard procedure, compared with 68% for a laparoscopic procedure and 71% for a robotic procedure.

Technological innovation made a difference in whether patients deemed certain information essential. Patients scheduled for a laparoscopic or robotic procedure were significantly more likely to want information than those undergoing a standard operation.

In all, 63% of patients said they would want to know the number of times that a standard procedure had been done by their surgeon. That percentage rose to 66% for a laparoscopic procedure and to 68% for a robotic procedure. Outcomes information was considered important by 63% of patients for a standard procedure, 66% for a laparoscopic procedure, and 67% for a robotic procedure. And 24% of patients, compared with 6% of surgeons, said the patient should be told if the surgeon planned to publish an article including the case. Disclosing whether a surgeon is a paid consultant was less important to patients (5%) than to surgeons (40%).

Dr. Char had no conflicts of interest.

References

Body

This study is an important one for all practicing surgeons. Informed consent is central to the practice of surgery, and disclosure of information is a cornerstone of the consent process. Nevertheless, as Dr. Char’s study so dramatically illustrates, surgeons and patients frequently disagree on which items must be disclosed in order to obtain informed consent.

A few important areas of discrepancy are revealed. For example, patients considered disclosure of how many times a surgeon had performed a specific procedure more important than did surgeons. Similarly, only 55% of surgeons thought it was important to disclose to patients whether they were performing an operation for the first time, whereas 79% of patients said that such information was essential. On the other hand, despite the national movement to disclose financial conflicts of interest, only 5% of patients wanted to know if their surgeon was a paid consultant to industry compared with 40% of surgeons who felt that this is important to disclose.

What conclusions should we draw from these discrepancies between what patients say they want to know and what surgeons say is important to disclose in the informed consent process? Most important, surgeons should realize the difficulties we have in accurately predicting what information will be important to our patients. If we assume that we know how much information our patients want, we will almost certainly guess incorrectly. As a result, a different strategy should be adopted. Surgeons should tailor their disclosure in the consent process to the specific information needs of the individual patient. This can readily be accomplished by asking, "What additional questions do you have?" or "What information do you need in order to feel comfortable consenting to this operation?" If surgeons were to be guided by their patients when tailoring the nature and amount of information they disclose, patients would more likely be satisfied with that disclosure and the consent process would be improved.

Dr. Peter Angelos is an ACS Fellow, professor of surgery, and associate director, MacLean Center for Clinical Medical Ethics, University of Chicago.

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This study is an important one for all practicing surgeons. Informed consent is central to the practice of surgery, and disclosure of information is a cornerstone of the consent process. Nevertheless, as Dr. Char’s study so dramatically illustrates, surgeons and patients frequently disagree on which items must be disclosed in order to obtain informed consent.

A few important areas of discrepancy are revealed. For example, patients considered disclosure of how many times a surgeon had performed a specific procedure more important than did surgeons. Similarly, only 55% of surgeons thought it was important to disclose to patients whether they were performing an operation for the first time, whereas 79% of patients said that such information was essential. On the other hand, despite the national movement to disclose financial conflicts of interest, only 5% of patients wanted to know if their surgeon was a paid consultant to industry compared with 40% of surgeons who felt that this is important to disclose.

What conclusions should we draw from these discrepancies between what patients say they want to know and what surgeons say is important to disclose in the informed consent process? Most important, surgeons should realize the difficulties we have in accurately predicting what information will be important to our patients. If we assume that we know how much information our patients want, we will almost certainly guess incorrectly. As a result, a different strategy should be adopted. Surgeons should tailor their disclosure in the consent process to the specific information needs of the individual patient. This can readily be accomplished by asking, "What additional questions do you have?" or "What information do you need in order to feel comfortable consenting to this operation?" If surgeons were to be guided by their patients when tailoring the nature and amount of information they disclose, patients would more likely be satisfied with that disclosure and the consent process would be improved.

Dr. Peter Angelos is an ACS Fellow, professor of surgery, and associate director, MacLean Center for Clinical Medical Ethics, University of Chicago.

Body

This study is an important one for all practicing surgeons. Informed consent is central to the practice of surgery, and disclosure of information is a cornerstone of the consent process. Nevertheless, as Dr. Char’s study so dramatically illustrates, surgeons and patients frequently disagree on which items must be disclosed in order to obtain informed consent.

A few important areas of discrepancy are revealed. For example, patients considered disclosure of how many times a surgeon had performed a specific procedure more important than did surgeons. Similarly, only 55% of surgeons thought it was important to disclose to patients whether they were performing an operation for the first time, whereas 79% of patients said that such information was essential. On the other hand, despite the national movement to disclose financial conflicts of interest, only 5% of patients wanted to know if their surgeon was a paid consultant to industry compared with 40% of surgeons who felt that this is important to disclose.

What conclusions should we draw from these discrepancies between what patients say they want to know and what surgeons say is important to disclose in the informed consent process? Most important, surgeons should realize the difficulties we have in accurately predicting what information will be important to our patients. If we assume that we know how much information our patients want, we will almost certainly guess incorrectly. As a result, a different strategy should be adopted. Surgeons should tailor their disclosure in the consent process to the specific information needs of the individual patient. This can readily be accomplished by asking, "What additional questions do you have?" or "What information do you need in order to feel comfortable consenting to this operation?" If surgeons were to be guided by their patients when tailoring the nature and amount of information they disclose, patients would more likely be satisfied with that disclosure and the consent process would be improved.

Dr. Peter Angelos is an ACS Fellow, professor of surgery, and associate director, MacLean Center for Clinical Medical Ethics, University of Chicago.

Title
A total of 63% of patients thought it essential to know the number of times a surgeon had performed a particular procedure.
A total of 63% of patients thought it essential to know the number of times a surgeon had performed a particular procedure.

SAN FRANCISCO – Recent surveys of patients and attending surgeons show differing views on disclosures, Dr. Susan Lee Char said at the clinical congress of the American College of Surgeons.

She and her associates surveyed 353 adult patients at their first postoperative clinic visit and 85 attending surgeons at hospitals affiliated with the University of California, San Francisco. The survey presented a hypothetical case of a patient’s undergoing elective partial hepatectomy and asked respondents to rate the importance of receiving or conveying various items of information on a 6-point Likert scale.

In all, 79% of patients said it’s essential to know if their surgeon would be doing a procedure for the first time on them, but only 55% of attending surgeons felt this was important information to disclose. A total of 63% of patients considered it essential to know the number of times a surgeon had performed a particular procedure and the outcomes in those cases, compared with just 25% and 20% of surgeons, respectively.

"The data suggest that surgeons do have an ethical obligation to disclose volumes and outcomes and if it’s the first time [they’re] doing a procedure," said Dr. Char, a surgical resident at the university who is also a lawyer. "This has possible legal implications."

The main barrier to surgeons’ disclosure may be a practical one, she added. Surgeons often don’t have data on the volumes and outcomes of their procedures.

Patients’ and attending surgeons’ perceptions of the importance of other types of information also differed significantly. A general description of the procedure was rated as important by 65% of patients vs. 58% of surgeons, and technical details of the procedure were important to 48% of patients and 13% of surgeons. Disclosure of risks and benefits of the procedure were deemed essential by 77% and 71% of patients, respectively, compared with 72% and 65% of surgeons, respectively. A total of 41% of patients and 5% of surgeons said the patient should be told the number of times the procedure has been done by other surgeons, and 44% of patients and 20% of surgeons said other surgeons’ outcomes should be disclosed.

A total of 64% of patients and 31% of surgeons believed it was important to discuss any special training by the surgeon doing the procedure. Some 64% of patients said they would want to be informed about the surgeon’s special training for a standard procedure, compared with 68% for a laparoscopic procedure and 71% for a robotic procedure.

Technological innovation made a difference in whether patients deemed certain information essential. Patients scheduled for a laparoscopic or robotic procedure were significantly more likely to want information than those undergoing a standard operation.

In all, 63% of patients said they would want to know the number of times that a standard procedure had been done by their surgeon. That percentage rose to 66% for a laparoscopic procedure and to 68% for a robotic procedure. Outcomes information was considered important by 63% of patients for a standard procedure, 66% for a laparoscopic procedure, and 67% for a robotic procedure. And 24% of patients, compared with 6% of surgeons, said the patient should be told if the surgeon planned to publish an article including the case. Disclosing whether a surgeon is a paid consultant was less important to patients (5%) than to surgeons (40%).

Dr. Char had no conflicts of interest.

SAN FRANCISCO – Recent surveys of patients and attending surgeons show differing views on disclosures, Dr. Susan Lee Char said at the clinical congress of the American College of Surgeons.

She and her associates surveyed 353 adult patients at their first postoperative clinic visit and 85 attending surgeons at hospitals affiliated with the University of California, San Francisco. The survey presented a hypothetical case of a patient’s undergoing elective partial hepatectomy and asked respondents to rate the importance of receiving or conveying various items of information on a 6-point Likert scale.

In all, 79% of patients said it’s essential to know if their surgeon would be doing a procedure for the first time on them, but only 55% of attending surgeons felt this was important information to disclose. A total of 63% of patients considered it essential to know the number of times a surgeon had performed a particular procedure and the outcomes in those cases, compared with just 25% and 20% of surgeons, respectively.

"The data suggest that surgeons do have an ethical obligation to disclose volumes and outcomes and if it’s the first time [they’re] doing a procedure," said Dr. Char, a surgical resident at the university who is also a lawyer. "This has possible legal implications."

The main barrier to surgeons’ disclosure may be a practical one, she added. Surgeons often don’t have data on the volumes and outcomes of their procedures.

Patients’ and attending surgeons’ perceptions of the importance of other types of information also differed significantly. A general description of the procedure was rated as important by 65% of patients vs. 58% of surgeons, and technical details of the procedure were important to 48% of patients and 13% of surgeons. Disclosure of risks and benefits of the procedure were deemed essential by 77% and 71% of patients, respectively, compared with 72% and 65% of surgeons, respectively. A total of 41% of patients and 5% of surgeons said the patient should be told the number of times the procedure has been done by other surgeons, and 44% of patients and 20% of surgeons said other surgeons’ outcomes should be disclosed.

A total of 64% of patients and 31% of surgeons believed it was important to discuss any special training by the surgeon doing the procedure. Some 64% of patients said they would want to be informed about the surgeon’s special training for a standard procedure, compared with 68% for a laparoscopic procedure and 71% for a robotic procedure.

Technological innovation made a difference in whether patients deemed certain information essential. Patients scheduled for a laparoscopic or robotic procedure were significantly more likely to want information than those undergoing a standard operation.

In all, 63% of patients said they would want to know the number of times that a standard procedure had been done by their surgeon. That percentage rose to 66% for a laparoscopic procedure and to 68% for a robotic procedure. Outcomes information was considered important by 63% of patients for a standard procedure, 66% for a laparoscopic procedure, and 67% for a robotic procedure. And 24% of patients, compared with 6% of surgeons, said the patient should be told if the surgeon planned to publish an article including the case. Disclosing whether a surgeon is a paid consultant was less important to patients (5%) than to surgeons (40%).

Dr. Char had no conflicts of interest.

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Patients and Surgeons Diverge on Disclosures
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Major Finding: Only 55% of surgeons believed they should disclose that they would be doing a surgery for the first time on a patient when getting informed consent, compared with 79% of patients.

Data Source: Surveys presenting a hypothetical case to 353 patients at postoperative clinic visits, and to 85 attending surgeons.

Disclosures: Dr. Char said she has no relevant conflicts of interest.

Patients and Surgeons Diverge on Disclosures

A total of 63% of patients thought it essential to know the number of times a surgeon had performed a particular procedure.
Article Type
Changed
Display Headline
Patients and Surgeons Diverge on Disclosures

SAN FRANCISCO – Recent surveys of patients and attending surgeons show differing views on disclosures, Dr. Susan Lee Char said at the clinical congress of the American College of Surgeons.

She and her associates surveyed 353 adult patients at their first postoperative clinic visit and 85 attending surgeons at hospitals affiliated with the University of California, San Francisco. The survey presented a hypothetical case of a patient’s undergoing elective partial hepatectomy and asked respondents to rate the importance of receiving or conveying various items of information on a 6-point Likert scale.

In all, 79% of patients said it’s essential to know if their surgeon would be doing a procedure for the first time on them, but only 55% of attending surgeons felt this was important information to disclose. A total of 63% of patients considered it essential to know the number of times a surgeon had performed a particular procedure and the outcomes in those cases, compared with just 25% and 20% of surgeons, respectively.

"The data suggest that surgeons do have an ethical obligation to disclose volumes and outcomes and if it’s the first time [they’re] doing a procedure," said Dr. Char, a surgical resident at the university who is also a lawyer. "This has possible legal implications."

The main barrier to surgeons’ disclosure may be a practical one, she added. Surgeons often don’t have data on the volumes and outcomes of their procedures.

Patients’ and attending surgeons’ perceptions of the importance of other types of information also differed significantly. A general description of the procedure was rated as important by 65% of patients vs. 58% of surgeons, and technical details of the procedure were important to 48% of patients and 13% of surgeons. Disclosure of risks and benefits of the procedure were deemed essential by 77% and 71% of patients, respectively, compared with 72% and 65% of surgeons, respectively. A total of 41% of patients and 5% of surgeons said the patient should be told the number of times the procedure has been done by other surgeons, and 44% of patients and 20% of surgeons said other surgeons’ outcomes should be disclosed.

A total of 64% of patients and 31% of surgeons believed it was important to discuss any special training by the surgeon doing the procedure. Some 64% of patients said they would want to be informed about the surgeon’s special training for a standard procedure, compared with 68% for a laparoscopic procedure and 71% for a robotic procedure.

Technological innovation made a difference in whether patients deemed certain information essential. Patients scheduled for a laparoscopic or robotic procedure were significantly more likely to want information than those undergoing a standard operation.

In all, 63% of patients said they would want to know the number of times that a standard procedure had been done by their surgeon. That percentage rose to 66% for a laparoscopic procedure and to 68% for a robotic procedure. Outcomes information was considered important by 63% of patients for a standard procedure, 66% for a laparoscopic procedure, and 67% for a robotic procedure. And 24% of patients, compared with 6% of surgeons, said the patient should be told if the surgeon planned to publish an article including the case. Disclosing whether a surgeon is a paid consultant was less important to patients (5%) than to surgeons (40%).

Dr. Char had no conflicts of interest.

References

Body

This study is an important one for all practicing surgeons. Informed consent is central to the practice of surgery, and disclosure of information is a cornerstone of the consent process. Nevertheless, as Dr. Char’s study so dramatically illustrates, surgeons and patients frequently disagree on which items must be disclosed in order to obtain informed consent.

A few important areas of discrepancy are revealed. For example, patients considered disclosure of how many times a surgeon had performed a specific procedure more important than did surgeons. Similarly, only 55% of surgeons thought it was important to disclose to patients whether they were performing an operation for the first time, whereas 79% of patients said that such information was essential. On the other hand, despite the national movement to disclose financial conflicts of interest, only 5% of patients wanted to know if their surgeon was a paid consultant to industry compared with 40% of surgeons who felt that this is important to disclose.

What conclusions should we draw from these discrepancies between what patients say they want to know and what surgeons say is important to disclose in the informed consent process? Most important, surgeons should realize the difficulties we have in accurately predicting what information will be important to our patients. If we assume that we know how much information our patients want, we will almost certainly guess incorrectly. As a result, a different strategy should be adopted. Surgeons should tailor their disclosure in the consent process to the specific information needs of the individual patient. This can readily be accomplished by asking, "What additional questions do you have?" or "What information do you need in order to feel comfortable consenting to this operation?" If surgeons were to be guided by their patients when tailoring the nature and amount of information they disclose, patients would more likely be satisfied with that disclosure and the consent process would be improved.

Dr. Peter Angelos is an ACS Fellow, professor of surgery, and associate director, MacLean Center for Clinical Medical Ethics, University of Chicago.

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Body

This study is an important one for all practicing surgeons. Informed consent is central to the practice of surgery, and disclosure of information is a cornerstone of the consent process. Nevertheless, as Dr. Char’s study so dramatically illustrates, surgeons and patients frequently disagree on which items must be disclosed in order to obtain informed consent.

A few important areas of discrepancy are revealed. For example, patients considered disclosure of how many times a surgeon had performed a specific procedure more important than did surgeons. Similarly, only 55% of surgeons thought it was important to disclose to patients whether they were performing an operation for the first time, whereas 79% of patients said that such information was essential. On the other hand, despite the national movement to disclose financial conflicts of interest, only 5% of patients wanted to know if their surgeon was a paid consultant to industry compared with 40% of surgeons who felt that this is important to disclose.

What conclusions should we draw from these discrepancies between what patients say they want to know and what surgeons say is important to disclose in the informed consent process? Most important, surgeons should realize the difficulties we have in accurately predicting what information will be important to our patients. If we assume that we know how much information our patients want, we will almost certainly guess incorrectly. As a result, a different strategy should be adopted. Surgeons should tailor their disclosure in the consent process to the specific information needs of the individual patient. This can readily be accomplished by asking, "What additional questions do you have?" or "What information do you need in order to feel comfortable consenting to this operation?" If surgeons were to be guided by their patients when tailoring the nature and amount of information they disclose, patients would more likely be satisfied with that disclosure and the consent process would be improved.

Dr. Peter Angelos is an ACS Fellow, professor of surgery, and associate director, MacLean Center for Clinical Medical Ethics, University of Chicago.

Body

This study is an important one for all practicing surgeons. Informed consent is central to the practice of surgery, and disclosure of information is a cornerstone of the consent process. Nevertheless, as Dr. Char’s study so dramatically illustrates, surgeons and patients frequently disagree on which items must be disclosed in order to obtain informed consent.

A few important areas of discrepancy are revealed. For example, patients considered disclosure of how many times a surgeon had performed a specific procedure more important than did surgeons. Similarly, only 55% of surgeons thought it was important to disclose to patients whether they were performing an operation for the first time, whereas 79% of patients said that such information was essential. On the other hand, despite the national movement to disclose financial conflicts of interest, only 5% of patients wanted to know if their surgeon was a paid consultant to industry compared with 40% of surgeons who felt that this is important to disclose.

What conclusions should we draw from these discrepancies between what patients say they want to know and what surgeons say is important to disclose in the informed consent process? Most important, surgeons should realize the difficulties we have in accurately predicting what information will be important to our patients. If we assume that we know how much information our patients want, we will almost certainly guess incorrectly. As a result, a different strategy should be adopted. Surgeons should tailor their disclosure in the consent process to the specific information needs of the individual patient. This can readily be accomplished by asking, "What additional questions do you have?" or "What information do you need in order to feel comfortable consenting to this operation?" If surgeons were to be guided by their patients when tailoring the nature and amount of information they disclose, patients would more likely be satisfied with that disclosure and the consent process would be improved.

Dr. Peter Angelos is an ACS Fellow, professor of surgery, and associate director, MacLean Center for Clinical Medical Ethics, University of Chicago.

Title
A total of 63% of patients thought it essential to know the number of times a surgeon had performed a particular procedure.
A total of 63% of patients thought it essential to know the number of times a surgeon had performed a particular procedure.

SAN FRANCISCO – Recent surveys of patients and attending surgeons show differing views on disclosures, Dr. Susan Lee Char said at the clinical congress of the American College of Surgeons.

She and her associates surveyed 353 adult patients at their first postoperative clinic visit and 85 attending surgeons at hospitals affiliated with the University of California, San Francisco. The survey presented a hypothetical case of a patient’s undergoing elective partial hepatectomy and asked respondents to rate the importance of receiving or conveying various items of information on a 6-point Likert scale.

In all, 79% of patients said it’s essential to know if their surgeon would be doing a procedure for the first time on them, but only 55% of attending surgeons felt this was important information to disclose. A total of 63% of patients considered it essential to know the number of times a surgeon had performed a particular procedure and the outcomes in those cases, compared with just 25% and 20% of surgeons, respectively.

"The data suggest that surgeons do have an ethical obligation to disclose volumes and outcomes and if it’s the first time [they’re] doing a procedure," said Dr. Char, a surgical resident at the university who is also a lawyer. "This has possible legal implications."

The main barrier to surgeons’ disclosure may be a practical one, she added. Surgeons often don’t have data on the volumes and outcomes of their procedures.

Patients’ and attending surgeons’ perceptions of the importance of other types of information also differed significantly. A general description of the procedure was rated as important by 65% of patients vs. 58% of surgeons, and technical details of the procedure were important to 48% of patients and 13% of surgeons. Disclosure of risks and benefits of the procedure were deemed essential by 77% and 71% of patients, respectively, compared with 72% and 65% of surgeons, respectively. A total of 41% of patients and 5% of surgeons said the patient should be told the number of times the procedure has been done by other surgeons, and 44% of patients and 20% of surgeons said other surgeons’ outcomes should be disclosed.

A total of 64% of patients and 31% of surgeons believed it was important to discuss any special training by the surgeon doing the procedure. Some 64% of patients said they would want to be informed about the surgeon’s special training for a standard procedure, compared with 68% for a laparoscopic procedure and 71% for a robotic procedure.

Technological innovation made a difference in whether patients deemed certain information essential. Patients scheduled for a laparoscopic or robotic procedure were significantly more likely to want information than those undergoing a standard operation.

In all, 63% of patients said they would want to know the number of times that a standard procedure had been done by their surgeon. That percentage rose to 66% for a laparoscopic procedure and to 68% for a robotic procedure. Outcomes information was considered important by 63% of patients for a standard procedure, 66% for a laparoscopic procedure, and 67% for a robotic procedure. And 24% of patients, compared with 6% of surgeons, said the patient should be told if the surgeon planned to publish an article including the case. Disclosing whether a surgeon is a paid consultant was less important to patients (5%) than to surgeons (40%).

Dr. Char had no conflicts of interest.

SAN FRANCISCO – Recent surveys of patients and attending surgeons show differing views on disclosures, Dr. Susan Lee Char said at the clinical congress of the American College of Surgeons.

She and her associates surveyed 353 adult patients at their first postoperative clinic visit and 85 attending surgeons at hospitals affiliated with the University of California, San Francisco. The survey presented a hypothetical case of a patient’s undergoing elective partial hepatectomy and asked respondents to rate the importance of receiving or conveying various items of information on a 6-point Likert scale.

In all, 79% of patients said it’s essential to know if their surgeon would be doing a procedure for the first time on them, but only 55% of attending surgeons felt this was important information to disclose. A total of 63% of patients considered it essential to know the number of times a surgeon had performed a particular procedure and the outcomes in those cases, compared with just 25% and 20% of surgeons, respectively.

"The data suggest that surgeons do have an ethical obligation to disclose volumes and outcomes and if it’s the first time [they’re] doing a procedure," said Dr. Char, a surgical resident at the university who is also a lawyer. "This has possible legal implications."

The main barrier to surgeons’ disclosure may be a practical one, she added. Surgeons often don’t have data on the volumes and outcomes of their procedures.

Patients’ and attending surgeons’ perceptions of the importance of other types of information also differed significantly. A general description of the procedure was rated as important by 65% of patients vs. 58% of surgeons, and technical details of the procedure were important to 48% of patients and 13% of surgeons. Disclosure of risks and benefits of the procedure were deemed essential by 77% and 71% of patients, respectively, compared with 72% and 65% of surgeons, respectively. A total of 41% of patients and 5% of surgeons said the patient should be told the number of times the procedure has been done by other surgeons, and 44% of patients and 20% of surgeons said other surgeons’ outcomes should be disclosed.

A total of 64% of patients and 31% of surgeons believed it was important to discuss any special training by the surgeon doing the procedure. Some 64% of patients said they would want to be informed about the surgeon’s special training for a standard procedure, compared with 68% for a laparoscopic procedure and 71% for a robotic procedure.

Technological innovation made a difference in whether patients deemed certain information essential. Patients scheduled for a laparoscopic or robotic procedure were significantly more likely to want information than those undergoing a standard operation.

In all, 63% of patients said they would want to know the number of times that a standard procedure had been done by their surgeon. That percentage rose to 66% for a laparoscopic procedure and to 68% for a robotic procedure. Outcomes information was considered important by 63% of patients for a standard procedure, 66% for a laparoscopic procedure, and 67% for a robotic procedure. And 24% of patients, compared with 6% of surgeons, said the patient should be told if the surgeon planned to publish an article including the case. Disclosing whether a surgeon is a paid consultant was less important to patients (5%) than to surgeons (40%).

Dr. Char had no conflicts of interest.

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Patients and Surgeons Diverge on Disclosures
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Inside the Article

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Major Finding: Only 55% of surgeons believed they should disclose that they would be doing a surgery for the first time on a patient when getting informed consent, compared with 79% of patients.

Data Source: Surveys presenting a hypothetical case to 353 patients at postoperative clinic visits, and to 85 attending surgeons.

Disclosures: Dr. Char said she has no relevant conflicts of interest.

Predicting Esophagogastric Cancer Therapy Response

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Predicting Esophagogastric Cancer Therapy Response

SAN FRANCISCO – A new 86-gene signature may add to metabolic imaging in guiding early treatment decisions for esophagogastric junction cancer, researchers reported.

The leptin gene, among others, stood out as having the potential to become a clinically useful biomarker in analyses that were presented at the meeting.

Dr. Russell Petty of the University of Aberdeen (Scotland) and colleagues studied 182 patients with locally advanced or metastatic disease. The investigators performed FDG-PET (18fluorodeoxyglucose–positron emission tomography) imaging and CT imaging, as well as gene expression profiling, and immunohistochemistry of pretreatment tumor tissue.

Results showed that among a subgroup of 14 patients who had a PET metabolic response to the first cycle of neoadjuvant chemotherapy, a set of 86 genes in pretreatment tumor tissue distinguished those who had a radiologic response on CT after completing all cycles of that chemotherapy, compared with those who did not respond. In a variety of predictive models, this gene signature correctly predicted radiologic response in all cases.

"We have shown that gene expression profiling can subclassify FDG-PET metabolic responders into those patients that will and will not subsequently go on to have a [radiologic] response. We have also shown that combining molecular biomarkers and FDG-PET allows an optimization of response prediction," Dr. Petty said at a meeting on gastrointestinal cancer sponosored by the American Society of Clinical Oncology.

This is key, as PET alone has a poor positive predictive value in this setting, with only half of PET responders to neoadjuvant chemotherapy eventually showing a histopathologic response.

"While I suppose there is little doubt that if we used PET in this way to make treatment decisions, we would have a system that would be better than unstratified empirical treatment, what it still means is that quite significant proportions of our patients will go on to receive ineffective and intensely toxic therapy," he commented.

A subsequent gene enrichment and pathway analysis identified a half-dozen pathways that provided potential mechanistic explanations for the different tumor behavior.

"Within the pathways identified, the adipocytokine-signaling pathway immediately caught our attention because of the strong known [epidemiologic] link between obesity and body weight, and esophagogastric adenocarcinoma," Dr. Petty noted.

Additional analyses specifically fingered the leptin gene (among others) and showed that among PET responders, leptin expression was higher in radiologic nonresponders than in responders (P = .026).

Yet, immunohistochemistry in an independent group of 154 patients showed that strong leptin staining was also associated with better survival (P = .021), an association that held up in multivariate analysis (hazard ratio, 0.85; P = .04).

In stratified analyses, patients with leptin-positive tumors derived little survival benefit from neoadjuvant chemotherapy, whereas those with leptin-negative tumors fared considerably better if they received this therapy (indeed, about as well as the positive group).

"Leptin in particular may be a molecular biomarker that is useful to combine with PET," Dr. Petty commented.

"Leptin expression is associated with chemoresistance, but at the same time is also a favorable therapy-independent biomarker, so this combination of predictive and therapy-independent prognostic impacts mean that leptin has the potential to be a clinically useful biomarker."

"I really think that this is groundbreaking. ... The real future is here" when it comes to predicting treatment response in this cancer, as suggested by this study and others," session cochair Dr. Mark Krasna of the St. Joseph Medical Center in Towson, Md., commented in an interview.

"The question now is, are we ready for prime time to adopt that throughout?"

At present, more research is needed, according to Dr. Krasna, such as the ongoing validation of the 86-gene signature and from trials like CALGB (Cancer and Leukemia Group B) 80803 exploring response-adaptive treatment in this cancer.

"I think those are the important things we can do today. We are ready for that," he concluded.

Dr. Petty and Dr. Krasna reported that they had no relevant financial conflicts of interest.

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SAN FRANCISCO – A new 86-gene signature may add to metabolic imaging in guiding early treatment decisions for esophagogastric junction cancer, researchers reported.

The leptin gene, among others, stood out as having the potential to become a clinically useful biomarker in analyses that were presented at the meeting.

Dr. Russell Petty of the University of Aberdeen (Scotland) and colleagues studied 182 patients with locally advanced or metastatic disease. The investigators performed FDG-PET (18fluorodeoxyglucose–positron emission tomography) imaging and CT imaging, as well as gene expression profiling, and immunohistochemistry of pretreatment tumor tissue.

Results showed that among a subgroup of 14 patients who had a PET metabolic response to the first cycle of neoadjuvant chemotherapy, a set of 86 genes in pretreatment tumor tissue distinguished those who had a radiologic response on CT after completing all cycles of that chemotherapy, compared with those who did not respond. In a variety of predictive models, this gene signature correctly predicted radiologic response in all cases.

"We have shown that gene expression profiling can subclassify FDG-PET metabolic responders into those patients that will and will not subsequently go on to have a [radiologic] response. We have also shown that combining molecular biomarkers and FDG-PET allows an optimization of response prediction," Dr. Petty said at a meeting on gastrointestinal cancer sponosored by the American Society of Clinical Oncology.

This is key, as PET alone has a poor positive predictive value in this setting, with only half of PET responders to neoadjuvant chemotherapy eventually showing a histopathologic response.

"While I suppose there is little doubt that if we used PET in this way to make treatment decisions, we would have a system that would be better than unstratified empirical treatment, what it still means is that quite significant proportions of our patients will go on to receive ineffective and intensely toxic therapy," he commented.

A subsequent gene enrichment and pathway analysis identified a half-dozen pathways that provided potential mechanistic explanations for the different tumor behavior.

"Within the pathways identified, the adipocytokine-signaling pathway immediately caught our attention because of the strong known [epidemiologic] link between obesity and body weight, and esophagogastric adenocarcinoma," Dr. Petty noted.

Additional analyses specifically fingered the leptin gene (among others) and showed that among PET responders, leptin expression was higher in radiologic nonresponders than in responders (P = .026).

Yet, immunohistochemistry in an independent group of 154 patients showed that strong leptin staining was also associated with better survival (P = .021), an association that held up in multivariate analysis (hazard ratio, 0.85; P = .04).

In stratified analyses, patients with leptin-positive tumors derived little survival benefit from neoadjuvant chemotherapy, whereas those with leptin-negative tumors fared considerably better if they received this therapy (indeed, about as well as the positive group).

"Leptin in particular may be a molecular biomarker that is useful to combine with PET," Dr. Petty commented.

"Leptin expression is associated with chemoresistance, but at the same time is also a favorable therapy-independent biomarker, so this combination of predictive and therapy-independent prognostic impacts mean that leptin has the potential to be a clinically useful biomarker."

"I really think that this is groundbreaking. ... The real future is here" when it comes to predicting treatment response in this cancer, as suggested by this study and others," session cochair Dr. Mark Krasna of the St. Joseph Medical Center in Towson, Md., commented in an interview.

"The question now is, are we ready for prime time to adopt that throughout?"

At present, more research is needed, according to Dr. Krasna, such as the ongoing validation of the 86-gene signature and from trials like CALGB (Cancer and Leukemia Group B) 80803 exploring response-adaptive treatment in this cancer.

"I think those are the important things we can do today. We are ready for that," he concluded.

Dr. Petty and Dr. Krasna reported that they had no relevant financial conflicts of interest.

SAN FRANCISCO – A new 86-gene signature may add to metabolic imaging in guiding early treatment decisions for esophagogastric junction cancer, researchers reported.

The leptin gene, among others, stood out as having the potential to become a clinically useful biomarker in analyses that were presented at the meeting.

Dr. Russell Petty of the University of Aberdeen (Scotland) and colleagues studied 182 patients with locally advanced or metastatic disease. The investigators performed FDG-PET (18fluorodeoxyglucose–positron emission tomography) imaging and CT imaging, as well as gene expression profiling, and immunohistochemistry of pretreatment tumor tissue.

Results showed that among a subgroup of 14 patients who had a PET metabolic response to the first cycle of neoadjuvant chemotherapy, a set of 86 genes in pretreatment tumor tissue distinguished those who had a radiologic response on CT after completing all cycles of that chemotherapy, compared with those who did not respond. In a variety of predictive models, this gene signature correctly predicted radiologic response in all cases.

"We have shown that gene expression profiling can subclassify FDG-PET metabolic responders into those patients that will and will not subsequently go on to have a [radiologic] response. We have also shown that combining molecular biomarkers and FDG-PET allows an optimization of response prediction," Dr. Petty said at a meeting on gastrointestinal cancer sponosored by the American Society of Clinical Oncology.

This is key, as PET alone has a poor positive predictive value in this setting, with only half of PET responders to neoadjuvant chemotherapy eventually showing a histopathologic response.

"While I suppose there is little doubt that if we used PET in this way to make treatment decisions, we would have a system that would be better than unstratified empirical treatment, what it still means is that quite significant proportions of our patients will go on to receive ineffective and intensely toxic therapy," he commented.

A subsequent gene enrichment and pathway analysis identified a half-dozen pathways that provided potential mechanistic explanations for the different tumor behavior.

"Within the pathways identified, the adipocytokine-signaling pathway immediately caught our attention because of the strong known [epidemiologic] link between obesity and body weight, and esophagogastric adenocarcinoma," Dr. Petty noted.

Additional analyses specifically fingered the leptin gene (among others) and showed that among PET responders, leptin expression was higher in radiologic nonresponders than in responders (P = .026).

Yet, immunohistochemistry in an independent group of 154 patients showed that strong leptin staining was also associated with better survival (P = .021), an association that held up in multivariate analysis (hazard ratio, 0.85; P = .04).

In stratified analyses, patients with leptin-positive tumors derived little survival benefit from neoadjuvant chemotherapy, whereas those with leptin-negative tumors fared considerably better if they received this therapy (indeed, about as well as the positive group).

"Leptin in particular may be a molecular biomarker that is useful to combine with PET," Dr. Petty commented.

"Leptin expression is associated with chemoresistance, but at the same time is also a favorable therapy-independent biomarker, so this combination of predictive and therapy-independent prognostic impacts mean that leptin has the potential to be a clinically useful biomarker."

"I really think that this is groundbreaking. ... The real future is here" when it comes to predicting treatment response in this cancer, as suggested by this study and others," session cochair Dr. Mark Krasna of the St. Joseph Medical Center in Towson, Md., commented in an interview.

"The question now is, are we ready for prime time to adopt that throughout?"

At present, more research is needed, according to Dr. Krasna, such as the ongoing validation of the 86-gene signature and from trials like CALGB (Cancer and Leukemia Group B) 80803 exploring response-adaptive treatment in this cancer.

"I think those are the important things we can do today. We are ready for that," he concluded.

Dr. Petty and Dr. Krasna reported that they had no relevant financial conflicts of interest.

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Major Finding: An 86-gene signature in pretreatment tumor tissue discriminated between early PET responders who had a radiologic response at the end of neoadjuvant chemotherapy vs. those who did not.

Data Source: An observational study of esophagogastric junction adenocarcinoma involving gene expression profile analysis in 28 patients and immunohistochemical and outcome analysis in 154 patients.

Disclosures: Dr. Petty and Dr. Krasna reported they had no relevant conflicts of interest.

Breath Markers May Improve Lung Cancer Screening

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Breath Markers May Improve Lung Cancer Screening

New noninvasive screening technologies are poised to improve the diagnostic yield of advanced imaging in lung cancer and, by so doing, improve patient outcomes. A blood test for detecting genetic mutations in circulating tumor cells of lung cancer specimens and a colorimetric sensor array that identifies cancerous compounds in exhaled human breath are among the technologies that could lead to earlier diagnosis and treatment, said Dr. Paul A. Bunn, executive director of the International Association for the Study of Lung Cancer (IASLC).

Lung cancer treatment has been hampered in the past by late diagnoses, typically achieved using invasive procedures only after symptoms have presented, said Dr. Bunn, the James Dudley Professor of Lung Cancer Research at the University of Colorado at Denver.

"Major breakthroughs are leading to interventions that make a huge difference and make it an exciting time for lung cancer," he said.

In particular, a test identifying lung cancer biomarkers through exhaled breath may also help clinicians and researchers identify which patients with abnormal CT scans need more aggressive follow-up. Dr. Nir Peled of Tel Hashomer, Israel, presented data from a comparative survey using breath analyses, in which investigators captured the "metabolic biosignatures" – the pattern of volatile organic compounds (VOCs) – of 74 patients with solitary pulmonary nodules to determine the VOC profiles for malignant and benign lung nodules.

"On analysis, two [VOCs] in patients’ exhaled breath showed statistically significant differences in concentration for benign and malignant lung nodules, and the sensor array distinguished between the corresponding collective VOC patterns with nearly 90% accuracy," Dr. Peled said in an interview.

Further, looking specifically at the malignant nodules, "the sensor array distinguished between small and non–small cell lung cancer with an accuracy approaching 94% and between early and advanced disease with nearly 90% accuracy."

Dr. Peled reported no disclosures.

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New noninvasive screening technologies are poised to improve the diagnostic yield of advanced imaging in lung cancer and, by so doing, improve patient outcomes. A blood test for detecting genetic mutations in circulating tumor cells of lung cancer specimens and a colorimetric sensor array that identifies cancerous compounds in exhaled human breath are among the technologies that could lead to earlier diagnosis and treatment, said Dr. Paul A. Bunn, executive director of the International Association for the Study of Lung Cancer (IASLC).

Lung cancer treatment has been hampered in the past by late diagnoses, typically achieved using invasive procedures only after symptoms have presented, said Dr. Bunn, the James Dudley Professor of Lung Cancer Research at the University of Colorado at Denver.

"Major breakthroughs are leading to interventions that make a huge difference and make it an exciting time for lung cancer," he said.

In particular, a test identifying lung cancer biomarkers through exhaled breath may also help clinicians and researchers identify which patients with abnormal CT scans need more aggressive follow-up. Dr. Nir Peled of Tel Hashomer, Israel, presented data from a comparative survey using breath analyses, in which investigators captured the "metabolic biosignatures" – the pattern of volatile organic compounds (VOCs) – of 74 patients with solitary pulmonary nodules to determine the VOC profiles for malignant and benign lung nodules.

"On analysis, two [VOCs] in patients’ exhaled breath showed statistically significant differences in concentration for benign and malignant lung nodules, and the sensor array distinguished between the corresponding collective VOC patterns with nearly 90% accuracy," Dr. Peled said in an interview.

Further, looking specifically at the malignant nodules, "the sensor array distinguished between small and non–small cell lung cancer with an accuracy approaching 94% and between early and advanced disease with nearly 90% accuracy."

Dr. Peled reported no disclosures.

New noninvasive screening technologies are poised to improve the diagnostic yield of advanced imaging in lung cancer and, by so doing, improve patient outcomes. A blood test for detecting genetic mutations in circulating tumor cells of lung cancer specimens and a colorimetric sensor array that identifies cancerous compounds in exhaled human breath are among the technologies that could lead to earlier diagnosis and treatment, said Dr. Paul A. Bunn, executive director of the International Association for the Study of Lung Cancer (IASLC).

Lung cancer treatment has been hampered in the past by late diagnoses, typically achieved using invasive procedures only after symptoms have presented, said Dr. Bunn, the James Dudley Professor of Lung Cancer Research at the University of Colorado at Denver.

"Major breakthroughs are leading to interventions that make a huge difference and make it an exciting time for lung cancer," he said.

In particular, a test identifying lung cancer biomarkers through exhaled breath may also help clinicians and researchers identify which patients with abnormal CT scans need more aggressive follow-up. Dr. Nir Peled of Tel Hashomer, Israel, presented data from a comparative survey using breath analyses, in which investigators captured the "metabolic biosignatures" – the pattern of volatile organic compounds (VOCs) – of 74 patients with solitary pulmonary nodules to determine the VOC profiles for malignant and benign lung nodules.

"On analysis, two [VOCs] in patients’ exhaled breath showed statistically significant differences in concentration for benign and malignant lung nodules, and the sensor array distinguished between the corresponding collective VOC patterns with nearly 90% accuracy," Dr. Peled said in an interview.

Further, looking specifically at the malignant nodules, "the sensor array distinguished between small and non–small cell lung cancer with an accuracy approaching 94% and between early and advanced disease with nearly 90% accuracy."

Dr. Peled reported no disclosures.

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Predicting Esophagogastric Cancer Therapy Response

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Predicting Esophagogastric Cancer Therapy Response

SAN FRANCISCO – A new 86-gene signature may add to metabolic imaging in guiding early treatment decisions for esophagogastric junction cancer, researchers reported.

The leptin gene, among others, stood out as having the potential to become a clinically useful biomarker in analyses that were presented at the meeting.

Dr. Russell Petty of the University of Aberdeen (Scotland) and colleagues studied 182 patients with locally advanced or metastatic disease. The investigators performed FDG-PET (18fluorodeoxyglucose–positron emission tomography) imaging and CT imaging, as well as gene expression profiling, and immunohistochemistry of pretreatment tumor tissue.

Results showed that among a subgroup of 14 patients who had a PET metabolic response to the first cycle of neoadjuvant chemotherapy, a set of 86 genes in pretreatment tumor tissue distinguished those who had a radiologic response on CT after completing all cycles of that chemotherapy, compared with those who did not respond. In a variety of predictive models, this gene signature correctly predicted radiologic response in all cases.

"We have shown that gene expression profiling can subclassify FDG-PET metabolic responders into those patients that will and will not subsequently go on to have a [radiologic] response. We have also shown that combining molecular biomarkers and FDG-PET allows an optimization of response prediction," Dr. Petty said at a meeting on gastrointestinal cancer sponosored by the American Society of Clinical Oncology.

This is key, as PET alone has a poor positive predictive value in this setting, with only half of PET responders to neoadjuvant chemotherapy eventually showing a histopathologic response.

"While I suppose there is little doubt that if we used PET in this way to make treatment decisions, we would have a system that would be better than unstratified empirical treatment, what it still means is that quite significant proportions of our patients will go on to receive ineffective and intensely toxic therapy," he commented.

A subsequent gene enrichment and pathway analysis identified a half-dozen pathways that provided potential mechanistic explanations for the different tumor behavior.

"Within the pathways identified, the adipocytokine-signaling pathway immediately caught our attention because of the strong known [epidemiologic] link between obesity and body weight, and esophagogastric adenocarcinoma," Dr. Petty noted.

Additional analyses specifically fingered the leptin gene (among others) and showed that among PET responders, leptin expression was higher in radiologic nonresponders than in responders (P = .026).

Yet, immunohistochemistry in an independent group of 154 patients showed that strong leptin staining was also associated with better survival (P = .021), an association that held up in multivariate analysis (hazard ratio, 0.85; P = .04).

In stratified analyses, patients with leptin-positive tumors derived little survival benefit from neoadjuvant chemotherapy, whereas those with leptin-negative tumors fared considerably better if they received this therapy (indeed, about as well as the positive group).

"Leptin in particular may be a molecular biomarker that is useful to combine with PET," Dr. Petty commented.

"Leptin expression is associated with chemoresistance, but at the same time is also a favorable therapy-independent biomarker, so this combination of predictive and therapy-independent prognostic impacts mean that leptin has the potential to be a clinically useful biomarker."

"I really think that this is groundbreaking. ... The real future is here" when it comes to predicting treatment response in this cancer, as suggested by this study and others," session cochair Dr. Mark Krasna of the St. Joseph Medical Center in Towson, Md., commented in an interview.

"The question now is, are we ready for prime time to adopt that throughout?"

At present, more research is needed, according to Dr. Krasna, such as the ongoing validation of the 86-gene signature and from trials like CALGB (Cancer and Leukemia Group B) 80803 exploring response-adaptive treatment in this cancer.

"I think those are the important things we can do today. We are ready for that," he concluded.

Dr. Petty and Dr. Krasna reported that they had no relevant financial conflicts of interest.

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SAN FRANCISCO – A new 86-gene signature may add to metabolic imaging in guiding early treatment decisions for esophagogastric junction cancer, researchers reported.

The leptin gene, among others, stood out as having the potential to become a clinically useful biomarker in analyses that were presented at the meeting.

Dr. Russell Petty of the University of Aberdeen (Scotland) and colleagues studied 182 patients with locally advanced or metastatic disease. The investigators performed FDG-PET (18fluorodeoxyglucose–positron emission tomography) imaging and CT imaging, as well as gene expression profiling, and immunohistochemistry of pretreatment tumor tissue.

Results showed that among a subgroup of 14 patients who had a PET metabolic response to the first cycle of neoadjuvant chemotherapy, a set of 86 genes in pretreatment tumor tissue distinguished those who had a radiologic response on CT after completing all cycles of that chemotherapy, compared with those who did not respond. In a variety of predictive models, this gene signature correctly predicted radiologic response in all cases.

"We have shown that gene expression profiling can subclassify FDG-PET metabolic responders into those patients that will and will not subsequently go on to have a [radiologic] response. We have also shown that combining molecular biomarkers and FDG-PET allows an optimization of response prediction," Dr. Petty said at a meeting on gastrointestinal cancer sponosored by the American Society of Clinical Oncology.

This is key, as PET alone has a poor positive predictive value in this setting, with only half of PET responders to neoadjuvant chemotherapy eventually showing a histopathologic response.

"While I suppose there is little doubt that if we used PET in this way to make treatment decisions, we would have a system that would be better than unstratified empirical treatment, what it still means is that quite significant proportions of our patients will go on to receive ineffective and intensely toxic therapy," he commented.

A subsequent gene enrichment and pathway analysis identified a half-dozen pathways that provided potential mechanistic explanations for the different tumor behavior.

"Within the pathways identified, the adipocytokine-signaling pathway immediately caught our attention because of the strong known [epidemiologic] link between obesity and body weight, and esophagogastric adenocarcinoma," Dr. Petty noted.

Additional analyses specifically fingered the leptin gene (among others) and showed that among PET responders, leptin expression was higher in radiologic nonresponders than in responders (P = .026).

Yet, immunohistochemistry in an independent group of 154 patients showed that strong leptin staining was also associated with better survival (P = .021), an association that held up in multivariate analysis (hazard ratio, 0.85; P = .04).

In stratified analyses, patients with leptin-positive tumors derived little survival benefit from neoadjuvant chemotherapy, whereas those with leptin-negative tumors fared considerably better if they received this therapy (indeed, about as well as the positive group).

"Leptin in particular may be a molecular biomarker that is useful to combine with PET," Dr. Petty commented.

"Leptin expression is associated with chemoresistance, but at the same time is also a favorable therapy-independent biomarker, so this combination of predictive and therapy-independent prognostic impacts mean that leptin has the potential to be a clinically useful biomarker."

"I really think that this is groundbreaking. ... The real future is here" when it comes to predicting treatment response in this cancer, as suggested by this study and others," session cochair Dr. Mark Krasna of the St. Joseph Medical Center in Towson, Md., commented in an interview.

"The question now is, are we ready for prime time to adopt that throughout?"

At present, more research is needed, according to Dr. Krasna, such as the ongoing validation of the 86-gene signature and from trials like CALGB (Cancer and Leukemia Group B) 80803 exploring response-adaptive treatment in this cancer.

"I think those are the important things we can do today. We are ready for that," he concluded.

Dr. Petty and Dr. Krasna reported that they had no relevant financial conflicts of interest.

SAN FRANCISCO – A new 86-gene signature may add to metabolic imaging in guiding early treatment decisions for esophagogastric junction cancer, researchers reported.

The leptin gene, among others, stood out as having the potential to become a clinically useful biomarker in analyses that were presented at the meeting.

Dr. Russell Petty of the University of Aberdeen (Scotland) and colleagues studied 182 patients with locally advanced or metastatic disease. The investigators performed FDG-PET (18fluorodeoxyglucose–positron emission tomography) imaging and CT imaging, as well as gene expression profiling, and immunohistochemistry of pretreatment tumor tissue.

Results showed that among a subgroup of 14 patients who had a PET metabolic response to the first cycle of neoadjuvant chemotherapy, a set of 86 genes in pretreatment tumor tissue distinguished those who had a radiologic response on CT after completing all cycles of that chemotherapy, compared with those who did not respond. In a variety of predictive models, this gene signature correctly predicted radiologic response in all cases.

"We have shown that gene expression profiling can subclassify FDG-PET metabolic responders into those patients that will and will not subsequently go on to have a [radiologic] response. We have also shown that combining molecular biomarkers and FDG-PET allows an optimization of response prediction," Dr. Petty said at a meeting on gastrointestinal cancer sponosored by the American Society of Clinical Oncology.

This is key, as PET alone has a poor positive predictive value in this setting, with only half of PET responders to neoadjuvant chemotherapy eventually showing a histopathologic response.

"While I suppose there is little doubt that if we used PET in this way to make treatment decisions, we would have a system that would be better than unstratified empirical treatment, what it still means is that quite significant proportions of our patients will go on to receive ineffective and intensely toxic therapy," he commented.

A subsequent gene enrichment and pathway analysis identified a half-dozen pathways that provided potential mechanistic explanations for the different tumor behavior.

"Within the pathways identified, the adipocytokine-signaling pathway immediately caught our attention because of the strong known [epidemiologic] link between obesity and body weight, and esophagogastric adenocarcinoma," Dr. Petty noted.

Additional analyses specifically fingered the leptin gene (among others) and showed that among PET responders, leptin expression was higher in radiologic nonresponders than in responders (P = .026).

Yet, immunohistochemistry in an independent group of 154 patients showed that strong leptin staining was also associated with better survival (P = .021), an association that held up in multivariate analysis (hazard ratio, 0.85; P = .04).

In stratified analyses, patients with leptin-positive tumors derived little survival benefit from neoadjuvant chemotherapy, whereas those with leptin-negative tumors fared considerably better if they received this therapy (indeed, about as well as the positive group).

"Leptin in particular may be a molecular biomarker that is useful to combine with PET," Dr. Petty commented.

"Leptin expression is associated with chemoresistance, but at the same time is also a favorable therapy-independent biomarker, so this combination of predictive and therapy-independent prognostic impacts mean that leptin has the potential to be a clinically useful biomarker."

"I really think that this is groundbreaking. ... The real future is here" when it comes to predicting treatment response in this cancer, as suggested by this study and others," session cochair Dr. Mark Krasna of the St. Joseph Medical Center in Towson, Md., commented in an interview.

"The question now is, are we ready for prime time to adopt that throughout?"

At present, more research is needed, according to Dr. Krasna, such as the ongoing validation of the 86-gene signature and from trials like CALGB (Cancer and Leukemia Group B) 80803 exploring response-adaptive treatment in this cancer.

"I think those are the important things we can do today. We are ready for that," he concluded.

Dr. Petty and Dr. Krasna reported that they had no relevant financial conflicts of interest.

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Predicting Esophagogastric Cancer Therapy Response
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Major Finding: An 86-gene signature in pretreatment tumor tissue discriminated between early PET responders who had a radiologic response at the end of neoadjuvant chemotherapy vs. those who did not.

Data Source: An observational study of esophagogastric junction adenocarcinoma involving gene expression profile analysis in 28 patients and immunohistochemical and outcome analysis in 154 patients.

Disclosures: Dr. Petty and Dr. Krasna reported they had no relevant conflicts of interest.

Breath Markers May Improve Lung Cancer Screening

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Breath Markers May Improve Lung Cancer Screening

New noninvasive screening technologies are poised to improve the diagnostic yield of advanced imaging in lung cancer and, by so doing, improve patient outcomes. A blood test for detecting genetic mutations in circulating tumor cells of lung cancer specimens and a colorimetric sensor array that identifies cancerous compounds in exhaled human breath are among the technologies that could lead to earlier diagnosis and treatment, said Dr. Paul A. Bunn, executive director of the International Association for the Study of Lung Cancer (IASLC).

Lung cancer treatment has been hampered in the past by late diagnoses, typically achieved using invasive procedures only after symptoms have presented, said Dr. Bunn, the James Dudley Professor of Lung Cancer Research at the University of Colorado at Denver.

"Major breakthroughs are leading to interventions that make a huge difference and make it an exciting time for lung cancer," he said.

In particular, a test identifying lung cancer biomarkers through exhaled breath may also help clinicians and researchers identify which patients with abnormal CT scans need more aggressive follow-up. Dr. Nir Peled of Tel Hashomer, Israel, presented data from a comparative survey using breath analyses, in which investigators captured the "metabolic biosignatures" – the pattern of volatile organic compounds (VOCs) – of 74 patients with solitary pulmonary nodules to determine the VOC profiles for malignant and benign lung nodules.

"On analysis, two [VOCs] in patients’ exhaled breath showed statistically significant differences in concentration for benign and malignant lung nodules, and the sensor array distinguished between the corresponding collective VOC patterns with nearly 90% accuracy," Dr. Peled said in an interview.

Further, looking specifically at the malignant nodules, "the sensor array distinguished between small and non–small cell lung cancer with an accuracy approaching 94% and between early and advanced disease with nearly 90% accuracy."

Dr. Peled reported no disclosures.

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New noninvasive screening technologies are poised to improve the diagnostic yield of advanced imaging in lung cancer and, by so doing, improve patient outcomes. A blood test for detecting genetic mutations in circulating tumor cells of lung cancer specimens and a colorimetric sensor array that identifies cancerous compounds in exhaled human breath are among the technologies that could lead to earlier diagnosis and treatment, said Dr. Paul A. Bunn, executive director of the International Association for the Study of Lung Cancer (IASLC).

Lung cancer treatment has been hampered in the past by late diagnoses, typically achieved using invasive procedures only after symptoms have presented, said Dr. Bunn, the James Dudley Professor of Lung Cancer Research at the University of Colorado at Denver.

"Major breakthroughs are leading to interventions that make a huge difference and make it an exciting time for lung cancer," he said.

In particular, a test identifying lung cancer biomarkers through exhaled breath may also help clinicians and researchers identify which patients with abnormal CT scans need more aggressive follow-up. Dr. Nir Peled of Tel Hashomer, Israel, presented data from a comparative survey using breath analyses, in which investigators captured the "metabolic biosignatures" – the pattern of volatile organic compounds (VOCs) – of 74 patients with solitary pulmonary nodules to determine the VOC profiles for malignant and benign lung nodules.

"On analysis, two [VOCs] in patients’ exhaled breath showed statistically significant differences in concentration for benign and malignant lung nodules, and the sensor array distinguished between the corresponding collective VOC patterns with nearly 90% accuracy," Dr. Peled said in an interview.

Further, looking specifically at the malignant nodules, "the sensor array distinguished between small and non–small cell lung cancer with an accuracy approaching 94% and between early and advanced disease with nearly 90% accuracy."

Dr. Peled reported no disclosures.

New noninvasive screening technologies are poised to improve the diagnostic yield of advanced imaging in lung cancer and, by so doing, improve patient outcomes. A blood test for detecting genetic mutations in circulating tumor cells of lung cancer specimens and a colorimetric sensor array that identifies cancerous compounds in exhaled human breath are among the technologies that could lead to earlier diagnosis and treatment, said Dr. Paul A. Bunn, executive director of the International Association for the Study of Lung Cancer (IASLC).

Lung cancer treatment has been hampered in the past by late diagnoses, typically achieved using invasive procedures only after symptoms have presented, said Dr. Bunn, the James Dudley Professor of Lung Cancer Research at the University of Colorado at Denver.

"Major breakthroughs are leading to interventions that make a huge difference and make it an exciting time for lung cancer," he said.

In particular, a test identifying lung cancer biomarkers through exhaled breath may also help clinicians and researchers identify which patients with abnormal CT scans need more aggressive follow-up. Dr. Nir Peled of Tel Hashomer, Israel, presented data from a comparative survey using breath analyses, in which investigators captured the "metabolic biosignatures" – the pattern of volatile organic compounds (VOCs) – of 74 patients with solitary pulmonary nodules to determine the VOC profiles for malignant and benign lung nodules.

"On analysis, two [VOCs] in patients’ exhaled breath showed statistically significant differences in concentration for benign and malignant lung nodules, and the sensor array distinguished between the corresponding collective VOC patterns with nearly 90% accuracy," Dr. Peled said in an interview.

Further, looking specifically at the malignant nodules, "the sensor array distinguished between small and non–small cell lung cancer with an accuracy approaching 94% and between early and advanced disease with nearly 90% accuracy."

Dr. Peled reported no disclosures.

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Feeding Regimen Moot For Critical ALI Patients?

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HOUSTON – Restricting the amount of initial enteral intake in mechanically ventilated patients who have acute lung injury neither reduces the duration of mechanical ventilation nor improves mortality relative to full enteral feeding, but the nutritional strategy may be slightly easier on the stomach, according to a study reported at the annual congress of the Society of Critical Care Medicine.

The importance of nutrition support in critically ill patients with acute lung injury (ALI) is well accepted as a means of maintaining gut integrity, modulating both stress and the systemic immune response, and attenuating disease severity, but conflicting data regarding the timing, formulation, and amount of enteral nutrition have contributed to uncertainty about the optimal feeding protocol, according to Dr. Todd W. Rice of Vanderbilt University Medical Center in Nashville, Tenn.

"How much nutrition we need to promote the protective benefits, we don’t know. Providing a little bit of nutrition (called trophic feeding) has been shown to decrease intestinal intolerances, compared with full-calorie feeds, but it may do so at the risk of malnutrition, worse immune function, and loss of muscle strength," he said. Full-calorie feeding, on the other hand, may lead to more intolerances, may cause hyperglycemia and other imbalances, may increase septic complications, and may fuel the inflammatory fire, he added.

In the current study, which was published simultaneously in JAMA, Dr. Rice and colleagues in the EDEN (Early vs. Delayed Enteral Nutrition in ALI) trial sought to examine the relative advantages of restricting the amount of initial enteral intake in mechanically ventilated ALI patients. Specifically, the prospective, randomized, open-label trial compared the effect on clinical outcomes and survival of initial trophic enteral feeding – approximately 25% of the full target feeding – with initial full-calorie feeding for the first 6 days of mechanical ventilation in ALI patients. "We hypothesized that reduced trophic feeding during the first [6 days] would increase ventilator-free days and reduce instances of gastrointestinal intolerances compared with the conventional full enteral nutrition strategy," he said.

The study’s primary end point was ventilator-free days through day 28; secondary end points were daily percentage of goal enteral feeding, frequency of gastrointestinal intolerances, 60-day mortality before hospital discharge with unassisted breathing, ICU- and organ failure–free days, and new infections (JAMA 2012 Feb. 5[doi:10.1001/jama2012.137]).

The multicenter study population comprised 1,000 patients, from January 2008 through mid-April 2011, who were initiated on mechanical ventilation within 48 hours of developing ALI. Within 6 hours of randomization, enteric nutrition was initiated in 508 patients assigned to trophic nutrition and 492 assigned to full feeding, and was continued until death, extubation, or day 6, Dr. Rice explained. Per standard protocol, enteral nutrition in the full-feeding group began at 25 mL/hr and advanced to goal weights (25-30 kcal/day of nonprotein calories and 1.2-1.6 g/kg per day of protein) as quickly as possible; gastric residual volumes were checked every 6 hours while enteral feeding was increased. In the trophic group, enteral feeding was initiated at 10-20 kcal/hr and gastric residual volumes were checked every 12 hours. After 6 days, patients in the trophic group who still required mechanical ventilation were advanced to the full-energy feeding rates, he said.

Baseline characteristics of the two groups were similar, Dr. Rice noted. "The primary etiologies of lung injury in both groups of patients were pneumonia and sepsis, and the average APACHE III [Acute Physiology and Chronic Health Evaluation III] score was approximately 92. These were sick patients," he said. For the first 6 days, the full- and trophic feeding groups received 1,300 kcal/day and 400 kcal/day, respectively.

With respect to the primary end point (28 days), the average number of ventilator-free days in both groups was similar, at 14.9 in the trophic group and 15.0 in the full-feeding group. "There were also no differences in 60-day mortality, organ failure–free days, ICU-free days, or the incidence of infection between groups," he said. Similarly, with respect to body mass index category or lung injury severity, "there were no between-group differences in ventilator free days or survival."

The full-feeding group did have a higher number of gastrointestinal intolerances on any one day, and statistically significant increase on days 2 and 3, but the overall percentages of intolerances were low, Dr. Rice said. There were no differences in albumin and protein levels between the groups over the first 7 days, he said.

Regarding the immediate clinical relevance of the findings, Dr. Rice stressed that the study wasn’t designed as an equivalence trial, "so I can’t tell you both feeding strategies are similar, but you can look at the results." In fact, he said, although the study did not show a benefit other than improved gastrointestinal tolerance, his group has moved toward trophic feeds because of the ease of administration

 

 

Dr. Rice had no financial conflicts.

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HOUSTON – Restricting the amount of initial enteral intake in mechanically ventilated patients who have acute lung injury neither reduces the duration of mechanical ventilation nor improves mortality relative to full enteral feeding, but the nutritional strategy may be slightly easier on the stomach, according to a study reported at the annual congress of the Society of Critical Care Medicine.

The importance of nutrition support in critically ill patients with acute lung injury (ALI) is well accepted as a means of maintaining gut integrity, modulating both stress and the systemic immune response, and attenuating disease severity, but conflicting data regarding the timing, formulation, and amount of enteral nutrition have contributed to uncertainty about the optimal feeding protocol, according to Dr. Todd W. Rice of Vanderbilt University Medical Center in Nashville, Tenn.

"How much nutrition we need to promote the protective benefits, we don’t know. Providing a little bit of nutrition (called trophic feeding) has been shown to decrease intestinal intolerances, compared with full-calorie feeds, but it may do so at the risk of malnutrition, worse immune function, and loss of muscle strength," he said. Full-calorie feeding, on the other hand, may lead to more intolerances, may cause hyperglycemia and other imbalances, may increase septic complications, and may fuel the inflammatory fire, he added.

In the current study, which was published simultaneously in JAMA, Dr. Rice and colleagues in the EDEN (Early vs. Delayed Enteral Nutrition in ALI) trial sought to examine the relative advantages of restricting the amount of initial enteral intake in mechanically ventilated ALI patients. Specifically, the prospective, randomized, open-label trial compared the effect on clinical outcomes and survival of initial trophic enteral feeding – approximately 25% of the full target feeding – with initial full-calorie feeding for the first 6 days of mechanical ventilation in ALI patients. "We hypothesized that reduced trophic feeding during the first [6 days] would increase ventilator-free days and reduce instances of gastrointestinal intolerances compared with the conventional full enteral nutrition strategy," he said.

The study’s primary end point was ventilator-free days through day 28; secondary end points were daily percentage of goal enteral feeding, frequency of gastrointestinal intolerances, 60-day mortality before hospital discharge with unassisted breathing, ICU- and organ failure–free days, and new infections (JAMA 2012 Feb. 5[doi:10.1001/jama2012.137]).

The multicenter study population comprised 1,000 patients, from January 2008 through mid-April 2011, who were initiated on mechanical ventilation within 48 hours of developing ALI. Within 6 hours of randomization, enteric nutrition was initiated in 508 patients assigned to trophic nutrition and 492 assigned to full feeding, and was continued until death, extubation, or day 6, Dr. Rice explained. Per standard protocol, enteral nutrition in the full-feeding group began at 25 mL/hr and advanced to goal weights (25-30 kcal/day of nonprotein calories and 1.2-1.6 g/kg per day of protein) as quickly as possible; gastric residual volumes were checked every 6 hours while enteral feeding was increased. In the trophic group, enteral feeding was initiated at 10-20 kcal/hr and gastric residual volumes were checked every 12 hours. After 6 days, patients in the trophic group who still required mechanical ventilation were advanced to the full-energy feeding rates, he said.

Baseline characteristics of the two groups were similar, Dr. Rice noted. "The primary etiologies of lung injury in both groups of patients were pneumonia and sepsis, and the average APACHE III [Acute Physiology and Chronic Health Evaluation III] score was approximately 92. These were sick patients," he said. For the first 6 days, the full- and trophic feeding groups received 1,300 kcal/day and 400 kcal/day, respectively.

With respect to the primary end point (28 days), the average number of ventilator-free days in both groups was similar, at 14.9 in the trophic group and 15.0 in the full-feeding group. "There were also no differences in 60-day mortality, organ failure–free days, ICU-free days, or the incidence of infection between groups," he said. Similarly, with respect to body mass index category or lung injury severity, "there were no between-group differences in ventilator free days or survival."

The full-feeding group did have a higher number of gastrointestinal intolerances on any one day, and statistically significant increase on days 2 and 3, but the overall percentages of intolerances were low, Dr. Rice said. There were no differences in albumin and protein levels between the groups over the first 7 days, he said.

Regarding the immediate clinical relevance of the findings, Dr. Rice stressed that the study wasn’t designed as an equivalence trial, "so I can’t tell you both feeding strategies are similar, but you can look at the results." In fact, he said, although the study did not show a benefit other than improved gastrointestinal tolerance, his group has moved toward trophic feeds because of the ease of administration

 

 

Dr. Rice had no financial conflicts.

HOUSTON – Restricting the amount of initial enteral intake in mechanically ventilated patients who have acute lung injury neither reduces the duration of mechanical ventilation nor improves mortality relative to full enteral feeding, but the nutritional strategy may be slightly easier on the stomach, according to a study reported at the annual congress of the Society of Critical Care Medicine.

The importance of nutrition support in critically ill patients with acute lung injury (ALI) is well accepted as a means of maintaining gut integrity, modulating both stress and the systemic immune response, and attenuating disease severity, but conflicting data regarding the timing, formulation, and amount of enteral nutrition have contributed to uncertainty about the optimal feeding protocol, according to Dr. Todd W. Rice of Vanderbilt University Medical Center in Nashville, Tenn.

"How much nutrition we need to promote the protective benefits, we don’t know. Providing a little bit of nutrition (called trophic feeding) has been shown to decrease intestinal intolerances, compared with full-calorie feeds, but it may do so at the risk of malnutrition, worse immune function, and loss of muscle strength," he said. Full-calorie feeding, on the other hand, may lead to more intolerances, may cause hyperglycemia and other imbalances, may increase septic complications, and may fuel the inflammatory fire, he added.

In the current study, which was published simultaneously in JAMA, Dr. Rice and colleagues in the EDEN (Early vs. Delayed Enteral Nutrition in ALI) trial sought to examine the relative advantages of restricting the amount of initial enteral intake in mechanically ventilated ALI patients. Specifically, the prospective, randomized, open-label trial compared the effect on clinical outcomes and survival of initial trophic enteral feeding – approximately 25% of the full target feeding – with initial full-calorie feeding for the first 6 days of mechanical ventilation in ALI patients. "We hypothesized that reduced trophic feeding during the first [6 days] would increase ventilator-free days and reduce instances of gastrointestinal intolerances compared with the conventional full enteral nutrition strategy," he said.

The study’s primary end point was ventilator-free days through day 28; secondary end points were daily percentage of goal enteral feeding, frequency of gastrointestinal intolerances, 60-day mortality before hospital discharge with unassisted breathing, ICU- and organ failure–free days, and new infections (JAMA 2012 Feb. 5[doi:10.1001/jama2012.137]).

The multicenter study population comprised 1,000 patients, from January 2008 through mid-April 2011, who were initiated on mechanical ventilation within 48 hours of developing ALI. Within 6 hours of randomization, enteric nutrition was initiated in 508 patients assigned to trophic nutrition and 492 assigned to full feeding, and was continued until death, extubation, or day 6, Dr. Rice explained. Per standard protocol, enteral nutrition in the full-feeding group began at 25 mL/hr and advanced to goal weights (25-30 kcal/day of nonprotein calories and 1.2-1.6 g/kg per day of protein) as quickly as possible; gastric residual volumes were checked every 6 hours while enteral feeding was increased. In the trophic group, enteral feeding was initiated at 10-20 kcal/hr and gastric residual volumes were checked every 12 hours. After 6 days, patients in the trophic group who still required mechanical ventilation were advanced to the full-energy feeding rates, he said.

Baseline characteristics of the two groups were similar, Dr. Rice noted. "The primary etiologies of lung injury in both groups of patients were pneumonia and sepsis, and the average APACHE III [Acute Physiology and Chronic Health Evaluation III] score was approximately 92. These were sick patients," he said. For the first 6 days, the full- and trophic feeding groups received 1,300 kcal/day and 400 kcal/day, respectively.

With respect to the primary end point (28 days), the average number of ventilator-free days in both groups was similar, at 14.9 in the trophic group and 15.0 in the full-feeding group. "There were also no differences in 60-day mortality, organ failure–free days, ICU-free days, or the incidence of infection between groups," he said. Similarly, with respect to body mass index category or lung injury severity, "there were no between-group differences in ventilator free days or survival."

The full-feeding group did have a higher number of gastrointestinal intolerances on any one day, and statistically significant increase on days 2 and 3, but the overall percentages of intolerances were low, Dr. Rice said. There were no differences in albumin and protein levels between the groups over the first 7 days, he said.

Regarding the immediate clinical relevance of the findings, Dr. Rice stressed that the study wasn’t designed as an equivalence trial, "so I can’t tell you both feeding strategies are similar, but you can look at the results." In fact, he said, although the study did not show a benefit other than improved gastrointestinal tolerance, his group has moved toward trophic feeds because of the ease of administration

 

 

Dr. Rice had no financial conflicts.

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Major Finding: At day 28, the average number of ventilator-free days in ALI patients who had been mechanically ventilated was 14.9 among those who received trophic enteral feeding for the first 6 days, followed by full-calorie feeding, and was 15.0 days among those who received full calorie enteral feeding from the outset.

Data Source: This was a multicenter, randomized, prospective, open-label trial comprising 1,000 mechanically ventilated ALI patients that was designed to assess the effect on clinical outcomes and survival of initial trophic enteral feeding, compared with full-calorie feeding, for the first 6 days of mechanical ventilation.

Disclosures: Dr. Rice and his fellow researchers disclosed having no financial conflicts of interest.

Feeding Regimen Moot For Critical ALI Patients?

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HOUSTON – Restricting the amount of initial enteral intake in mechanically ventilated patients who have acute lung injury neither reduces the duration of mechanical ventilation nor improves mortality relative to full enteral feeding, but the nutritional strategy may be slightly easier on the stomach, according to a study reported at the annual congress of the Society of Critical Care Medicine.

The importance of nutrition support in critically ill patients with acute lung injury (ALI) is well accepted as a means of maintaining gut integrity, modulating both stress and the systemic immune response, and attenuating disease severity, but conflicting data regarding the timing, formulation, and amount of enteral nutrition have contributed to uncertainty about the optimal feeding protocol, according to Dr. Todd W. Rice of Vanderbilt University Medical Center in Nashville, Tenn.

"How much nutrition we need to promote the protective benefits, we don’t know. Providing a little bit of nutrition (called trophic feeding) has been shown to decrease intestinal intolerances, compared with full-calorie feeds, but it may do so at the risk of malnutrition, worse immune function, and loss of muscle strength," he said. Full-calorie feeding, on the other hand, may lead to more intolerances, may cause hyperglycemia and other imbalances, may increase septic complications, and may fuel the inflammatory fire, he added.

In the current study, which was published simultaneously in JAMA, Dr. Rice and colleagues in the EDEN (Early vs. Delayed Enteral Nutrition in ALI) trial sought to examine the relative advantages of restricting the amount of initial enteral intake in mechanically ventilated ALI patients. Specifically, the prospective, randomized, open-label trial compared the effect on clinical outcomes and survival of initial trophic enteral feeding – approximately 25% of the full target feeding – with initial full-calorie feeding for the first 6 days of mechanical ventilation in ALI patients. "We hypothesized that reduced trophic feeding during the first [6 days] would increase ventilator-free days and reduce instances of gastrointestinal intolerances compared with the conventional full enteral nutrition strategy," he said.

The study’s primary end point was ventilator-free days through day 28; secondary end points were daily percentage of goal enteral feeding, frequency of gastrointestinal intolerances, 60-day mortality before hospital discharge with unassisted breathing, ICU- and organ failure–free days, and new infections (JAMA 2012 Feb. 5[doi:10.1001/jama2012.137]).

The multicenter study population comprised 1,000 patients, from January 2008 through mid-April 2011, who were initiated on mechanical ventilation within 48 hours of developing ALI. Within 6 hours of randomization, enteric nutrition was initiated in 508 patients assigned to trophic nutrition and 492 assigned to full feeding, and was continued until death, extubation, or day 6, Dr. Rice explained. Per standard protocol, enteral nutrition in the full-feeding group began at 25 mL/hr and advanced to goal weights (25-30 kcal/day of nonprotein calories and 1.2-1.6 g/kg per day of protein) as quickly as possible; gastric residual volumes were checked every 6 hours while enteral feeding was increased. In the trophic group, enteral feeding was initiated at 10-20 kcal/hr and gastric residual volumes were checked every 12 hours. After 6 days, patients in the trophic group who still required mechanical ventilation were advanced to the full-energy feeding rates, he said.

Baseline characteristics of the two groups were similar, Dr. Rice noted. "The primary etiologies of lung injury in both groups of patients were pneumonia and sepsis, and the average APACHE III [Acute Physiology and Chronic Health Evaluation III] score was approximately 92. These were sick patients," he said. For the first 6 days, the full- and trophic feeding groups received 1,300 kcal/day and 400 kcal/day, respectively.

With respect to the primary end point (28 days), the average number of ventilator-free days in both groups was similar, at 14.9 in the trophic group and 15.0 in the full-feeding group. "There were also no differences in 60-day mortality, organ failure–free days, ICU-free days, or the incidence of infection between groups," he said. Similarly, with respect to body mass index category or lung injury severity, "there were no between-group differences in ventilator free days or survival."

The full-feeding group did have a higher number of gastrointestinal intolerances on any one day, and statistically significant increase on days 2 and 3, but the overall percentages of intolerances were low, Dr. Rice said. There were no differences in albumin and protein levels between the groups over the first 7 days, he said.

Regarding the immediate clinical relevance of the findings, Dr. Rice stressed that the study wasn’t designed as an equivalence trial, "so I can’t tell you both feeding strategies are similar, but you can look at the results." In fact, he said, although the study did not show a benefit other than improved gastrointestinal tolerance, his group has moved toward trophic feeds because of the ease of administration

 

 

Dr. Rice had no financial conflicts.

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HOUSTON – Restricting the amount of initial enteral intake in mechanically ventilated patients who have acute lung injury neither reduces the duration of mechanical ventilation nor improves mortality relative to full enteral feeding, but the nutritional strategy may be slightly easier on the stomach, according to a study reported at the annual congress of the Society of Critical Care Medicine.

The importance of nutrition support in critically ill patients with acute lung injury (ALI) is well accepted as a means of maintaining gut integrity, modulating both stress and the systemic immune response, and attenuating disease severity, but conflicting data regarding the timing, formulation, and amount of enteral nutrition have contributed to uncertainty about the optimal feeding protocol, according to Dr. Todd W. Rice of Vanderbilt University Medical Center in Nashville, Tenn.

"How much nutrition we need to promote the protective benefits, we don’t know. Providing a little bit of nutrition (called trophic feeding) has been shown to decrease intestinal intolerances, compared with full-calorie feeds, but it may do so at the risk of malnutrition, worse immune function, and loss of muscle strength," he said. Full-calorie feeding, on the other hand, may lead to more intolerances, may cause hyperglycemia and other imbalances, may increase septic complications, and may fuel the inflammatory fire, he added.

In the current study, which was published simultaneously in JAMA, Dr. Rice and colleagues in the EDEN (Early vs. Delayed Enteral Nutrition in ALI) trial sought to examine the relative advantages of restricting the amount of initial enteral intake in mechanically ventilated ALI patients. Specifically, the prospective, randomized, open-label trial compared the effect on clinical outcomes and survival of initial trophic enteral feeding – approximately 25% of the full target feeding – with initial full-calorie feeding for the first 6 days of mechanical ventilation in ALI patients. "We hypothesized that reduced trophic feeding during the first [6 days] would increase ventilator-free days and reduce instances of gastrointestinal intolerances compared with the conventional full enteral nutrition strategy," he said.

The study’s primary end point was ventilator-free days through day 28; secondary end points were daily percentage of goal enteral feeding, frequency of gastrointestinal intolerances, 60-day mortality before hospital discharge with unassisted breathing, ICU- and organ failure–free days, and new infections (JAMA 2012 Feb. 5[doi:10.1001/jama2012.137]).

The multicenter study population comprised 1,000 patients, from January 2008 through mid-April 2011, who were initiated on mechanical ventilation within 48 hours of developing ALI. Within 6 hours of randomization, enteric nutrition was initiated in 508 patients assigned to trophic nutrition and 492 assigned to full feeding, and was continued until death, extubation, or day 6, Dr. Rice explained. Per standard protocol, enteral nutrition in the full-feeding group began at 25 mL/hr and advanced to goal weights (25-30 kcal/day of nonprotein calories and 1.2-1.6 g/kg per day of protein) as quickly as possible; gastric residual volumes were checked every 6 hours while enteral feeding was increased. In the trophic group, enteral feeding was initiated at 10-20 kcal/hr and gastric residual volumes were checked every 12 hours. After 6 days, patients in the trophic group who still required mechanical ventilation were advanced to the full-energy feeding rates, he said.

Baseline characteristics of the two groups were similar, Dr. Rice noted. "The primary etiologies of lung injury in both groups of patients were pneumonia and sepsis, and the average APACHE III [Acute Physiology and Chronic Health Evaluation III] score was approximately 92. These were sick patients," he said. For the first 6 days, the full- and trophic feeding groups received 1,300 kcal/day and 400 kcal/day, respectively.

With respect to the primary end point (28 days), the average number of ventilator-free days in both groups was similar, at 14.9 in the trophic group and 15.0 in the full-feeding group. "There were also no differences in 60-day mortality, organ failure–free days, ICU-free days, or the incidence of infection between groups," he said. Similarly, with respect to body mass index category or lung injury severity, "there were no between-group differences in ventilator free days or survival."

The full-feeding group did have a higher number of gastrointestinal intolerances on any one day, and statistically significant increase on days 2 and 3, but the overall percentages of intolerances were low, Dr. Rice said. There were no differences in albumin and protein levels between the groups over the first 7 days, he said.

Regarding the immediate clinical relevance of the findings, Dr. Rice stressed that the study wasn’t designed as an equivalence trial, "so I can’t tell you both feeding strategies are similar, but you can look at the results." In fact, he said, although the study did not show a benefit other than improved gastrointestinal tolerance, his group has moved toward trophic feeds because of the ease of administration

 

 

Dr. Rice had no financial conflicts.

HOUSTON – Restricting the amount of initial enteral intake in mechanically ventilated patients who have acute lung injury neither reduces the duration of mechanical ventilation nor improves mortality relative to full enteral feeding, but the nutritional strategy may be slightly easier on the stomach, according to a study reported at the annual congress of the Society of Critical Care Medicine.

The importance of nutrition support in critically ill patients with acute lung injury (ALI) is well accepted as a means of maintaining gut integrity, modulating both stress and the systemic immune response, and attenuating disease severity, but conflicting data regarding the timing, formulation, and amount of enteral nutrition have contributed to uncertainty about the optimal feeding protocol, according to Dr. Todd W. Rice of Vanderbilt University Medical Center in Nashville, Tenn.

"How much nutrition we need to promote the protective benefits, we don’t know. Providing a little bit of nutrition (called trophic feeding) has been shown to decrease intestinal intolerances, compared with full-calorie feeds, but it may do so at the risk of malnutrition, worse immune function, and loss of muscle strength," he said. Full-calorie feeding, on the other hand, may lead to more intolerances, may cause hyperglycemia and other imbalances, may increase septic complications, and may fuel the inflammatory fire, he added.

In the current study, which was published simultaneously in JAMA, Dr. Rice and colleagues in the EDEN (Early vs. Delayed Enteral Nutrition in ALI) trial sought to examine the relative advantages of restricting the amount of initial enteral intake in mechanically ventilated ALI patients. Specifically, the prospective, randomized, open-label trial compared the effect on clinical outcomes and survival of initial trophic enteral feeding – approximately 25% of the full target feeding – with initial full-calorie feeding for the first 6 days of mechanical ventilation in ALI patients. "We hypothesized that reduced trophic feeding during the first [6 days] would increase ventilator-free days and reduce instances of gastrointestinal intolerances compared with the conventional full enteral nutrition strategy," he said.

The study’s primary end point was ventilator-free days through day 28; secondary end points were daily percentage of goal enteral feeding, frequency of gastrointestinal intolerances, 60-day mortality before hospital discharge with unassisted breathing, ICU- and organ failure–free days, and new infections (JAMA 2012 Feb. 5[doi:10.1001/jama2012.137]).

The multicenter study population comprised 1,000 patients, from January 2008 through mid-April 2011, who were initiated on mechanical ventilation within 48 hours of developing ALI. Within 6 hours of randomization, enteric nutrition was initiated in 508 patients assigned to trophic nutrition and 492 assigned to full feeding, and was continued until death, extubation, or day 6, Dr. Rice explained. Per standard protocol, enteral nutrition in the full-feeding group began at 25 mL/hr and advanced to goal weights (25-30 kcal/day of nonprotein calories and 1.2-1.6 g/kg per day of protein) as quickly as possible; gastric residual volumes were checked every 6 hours while enteral feeding was increased. In the trophic group, enteral feeding was initiated at 10-20 kcal/hr and gastric residual volumes were checked every 12 hours. After 6 days, patients in the trophic group who still required mechanical ventilation were advanced to the full-energy feeding rates, he said.

Baseline characteristics of the two groups were similar, Dr. Rice noted. "The primary etiologies of lung injury in both groups of patients were pneumonia and sepsis, and the average APACHE III [Acute Physiology and Chronic Health Evaluation III] score was approximately 92. These were sick patients," he said. For the first 6 days, the full- and trophic feeding groups received 1,300 kcal/day and 400 kcal/day, respectively.

With respect to the primary end point (28 days), the average number of ventilator-free days in both groups was similar, at 14.9 in the trophic group and 15.0 in the full-feeding group. "There were also no differences in 60-day mortality, organ failure–free days, ICU-free days, or the incidence of infection between groups," he said. Similarly, with respect to body mass index category or lung injury severity, "there were no between-group differences in ventilator free days or survival."

The full-feeding group did have a higher number of gastrointestinal intolerances on any one day, and statistically significant increase on days 2 and 3, but the overall percentages of intolerances were low, Dr. Rice said. There were no differences in albumin and protein levels between the groups over the first 7 days, he said.

Regarding the immediate clinical relevance of the findings, Dr. Rice stressed that the study wasn’t designed as an equivalence trial, "so I can’t tell you both feeding strategies are similar, but you can look at the results." In fact, he said, although the study did not show a benefit other than improved gastrointestinal tolerance, his group has moved toward trophic feeds because of the ease of administration

 

 

Dr. Rice had no financial conflicts.

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Major Finding: At day 28, the average number of ventilator-free days in ALI patients who had been mechanically ventilated was 14.9 among those who received trophic enteral feeding for the first 6 days, followed by full-calorie feeding, and was 15.0 days among those who received full calorie enteral feeding from the outset.

Data Source: This was a multicenter, randomized, prospective, open-label trial comprising 1,000 mechanically ventilated ALI patients that was designed to assess the effect on clinical outcomes and survival of initial trophic enteral feeding, compared with full-calorie feeding, for the first 6 days of mechanical ventilation.

Disclosures: Dr. Rice and his fellow researchers disclosed having no financial conflicts of interest.

Vascular Training May Serve as Model for Other Programs

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The first graduates of the integrated 0-5 vascular surgery residency programs will hit the workforce in July, providing an early glimpse into whether trainees in this new paradigm are as prepared to handle the rigors of practice as those who spent more time in residency.

"I suppose time will tell, Dr. Richard P. Cambria, current Society for Vascular Surgery (SVS) president told an audience of thoracic surgeons.

Dr. Cambria

Dr. Cambria, who is also chief of the division of vascular and endovascular surgery and codirector of the Thoracic Aortic Center at Massachusetts General Hospital in Boston, discussed the evolution of vascular surgery training over the last 5 years during in a special session at the Society of Thoracic Surgeons (STS) annual meeting that addressed mutual issues between cardiothoracic surgery and vascular surgery.

The 0-5 program was inaugurated in 2007 and arose from a variety of concerns. The scope of vascular surgery was rapidly changing with the rise of endovascular techniques, and there became a consensus feeling that this required more time for residents to be dedicated to specific vascular training. In addition there was a general dissatisfaction with the growing diffuseness of general surgery education with its tendencey to train surgeons in an ever-increasing variety of techniques, many of which had no pertinence to vascular surgerons. The session was part of a larger "STS/AATS/SVS: What’s New in Peripheral Vascular Disease Management" collaborative program.

According to Dr. Cambria, the 0-5 vascular surgery residency program allows candidates for vascular surgery residencies to match directly out of medical school into a 5-year vascular surgery residency, bypassing 2 years of general surgery residency.

Over the next 5 years, the performance of the programs’ first graduates will be assessed based on how they score on their vascular surgery board exams, if they are able to meet board certification requirements for the number of surgical cases performed, and where they get hired, he said.

But if the success of the 0-5 training program is measured only in terms of popularity, then it has already succeeded, Dr. Cambria said. Today, there are about 38 vascular surgery residency training programs open using the 0-5 pathway and there are many more applicants than available positions. The 0-5 vascular surgery residency program isn’t just the most popular option for vascular surgeons in training, it’s one of the most popular surgery training programs offered by Accreditation Council for Graduate Medical Education (ACGME)-accredited fellowship or residency programs, Dr. Cambria said.

Meanwhile, the traditional 5+2 programs, which include 2 years of general surgery residency followed by 5 years of vascular surgery residency, have a "healthy" applicant pool but are generally not oversubscribed, he said.

The roll out of the 0-5 vascular surgery training programs nationwide could hold lessons for the cardiothoracic surgery community, which has struggled with an inadequate applicant pool for their training programs.

One solution, according to Dr. Cambria, could be to expand their own 0-6 residency programs, which are akin to the 0-5 vascular surgery residency pathway.

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The 0-5 vascular surgery training program is one of themost popular offered by ACGME-accredited programs.Dr. Cambria
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The 0-5 vascular surgery training program is one of themost popular offered by ACGME-accredited programs.Dr. Cambria

The first graduates of the integrated 0-5 vascular surgery residency programs will hit the workforce in July, providing an early glimpse into whether trainees in this new paradigm are as prepared to handle the rigors of practice as those who spent more time in residency.

"I suppose time will tell, Dr. Richard P. Cambria, current Society for Vascular Surgery (SVS) president told an audience of thoracic surgeons.

Dr. Cambria

Dr. Cambria, who is also chief of the division of vascular and endovascular surgery and codirector of the Thoracic Aortic Center at Massachusetts General Hospital in Boston, discussed the evolution of vascular surgery training over the last 5 years during in a special session at the Society of Thoracic Surgeons (STS) annual meeting that addressed mutual issues between cardiothoracic surgery and vascular surgery.

The 0-5 program was inaugurated in 2007 and arose from a variety of concerns. The scope of vascular surgery was rapidly changing with the rise of endovascular techniques, and there became a consensus feeling that this required more time for residents to be dedicated to specific vascular training. In addition there was a general dissatisfaction with the growing diffuseness of general surgery education with its tendencey to train surgeons in an ever-increasing variety of techniques, many of which had no pertinence to vascular surgerons. The session was part of a larger "STS/AATS/SVS: What’s New in Peripheral Vascular Disease Management" collaborative program.

According to Dr. Cambria, the 0-5 vascular surgery residency program allows candidates for vascular surgery residencies to match directly out of medical school into a 5-year vascular surgery residency, bypassing 2 years of general surgery residency.

Over the next 5 years, the performance of the programs’ first graduates will be assessed based on how they score on their vascular surgery board exams, if they are able to meet board certification requirements for the number of surgical cases performed, and where they get hired, he said.

But if the success of the 0-5 training program is measured only in terms of popularity, then it has already succeeded, Dr. Cambria said. Today, there are about 38 vascular surgery residency training programs open using the 0-5 pathway and there are many more applicants than available positions. The 0-5 vascular surgery residency program isn’t just the most popular option for vascular surgeons in training, it’s one of the most popular surgery training programs offered by Accreditation Council for Graduate Medical Education (ACGME)-accredited fellowship or residency programs, Dr. Cambria said.

Meanwhile, the traditional 5+2 programs, which include 2 years of general surgery residency followed by 5 years of vascular surgery residency, have a "healthy" applicant pool but are generally not oversubscribed, he said.

The roll out of the 0-5 vascular surgery training programs nationwide could hold lessons for the cardiothoracic surgery community, which has struggled with an inadequate applicant pool for their training programs.

One solution, according to Dr. Cambria, could be to expand their own 0-6 residency programs, which are akin to the 0-5 vascular surgery residency pathway.

The first graduates of the integrated 0-5 vascular surgery residency programs will hit the workforce in July, providing an early glimpse into whether trainees in this new paradigm are as prepared to handle the rigors of practice as those who spent more time in residency.

"I suppose time will tell, Dr. Richard P. Cambria, current Society for Vascular Surgery (SVS) president told an audience of thoracic surgeons.

Dr. Cambria

Dr. Cambria, who is also chief of the division of vascular and endovascular surgery and codirector of the Thoracic Aortic Center at Massachusetts General Hospital in Boston, discussed the evolution of vascular surgery training over the last 5 years during in a special session at the Society of Thoracic Surgeons (STS) annual meeting that addressed mutual issues between cardiothoracic surgery and vascular surgery.

The 0-5 program was inaugurated in 2007 and arose from a variety of concerns. The scope of vascular surgery was rapidly changing with the rise of endovascular techniques, and there became a consensus feeling that this required more time for residents to be dedicated to specific vascular training. In addition there was a general dissatisfaction with the growing diffuseness of general surgery education with its tendencey to train surgeons in an ever-increasing variety of techniques, many of which had no pertinence to vascular surgerons. The session was part of a larger "STS/AATS/SVS: What’s New in Peripheral Vascular Disease Management" collaborative program.

According to Dr. Cambria, the 0-5 vascular surgery residency program allows candidates for vascular surgery residencies to match directly out of medical school into a 5-year vascular surgery residency, bypassing 2 years of general surgery residency.

Over the next 5 years, the performance of the programs’ first graduates will be assessed based on how they score on their vascular surgery board exams, if they are able to meet board certification requirements for the number of surgical cases performed, and where they get hired, he said.

But if the success of the 0-5 training program is measured only in terms of popularity, then it has already succeeded, Dr. Cambria said. Today, there are about 38 vascular surgery residency training programs open using the 0-5 pathway and there are many more applicants than available positions. The 0-5 vascular surgery residency program isn’t just the most popular option for vascular surgeons in training, it’s one of the most popular surgery training programs offered by Accreditation Council for Graduate Medical Education (ACGME)-accredited fellowship or residency programs, Dr. Cambria said.

Meanwhile, the traditional 5+2 programs, which include 2 years of general surgery residency followed by 5 years of vascular surgery residency, have a "healthy" applicant pool but are generally not oversubscribed, he said.

The roll out of the 0-5 vascular surgery training programs nationwide could hold lessons for the cardiothoracic surgery community, which has struggled with an inadequate applicant pool for their training programs.

One solution, according to Dr. Cambria, could be to expand their own 0-6 residency programs, which are akin to the 0-5 vascular surgery residency pathway.

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AATS Resident Resources: www.aats.org/TSR/index.html

CTSNET Residents Section: www.ctsnet.org/sections/residents

Thoracic Surgery Directors Association: www.tsda.org

Thoracic Surgery News: www.thoracicsurgerynews.com

Thoracic Surgery Residents Association: www.tsranet.org

Thoracic Surgery Foundation for Research and Education: www.tsfre.org

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AATS Resident Resources: www.aats.org/TSR/index.html

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Thoracic Surgery Directors Association: www.tsda.org

Thoracic Surgery News: www.thoracicsurgerynews.com

Thoracic Surgery Residents Association: www.tsranet.org

Thoracic Surgery Foundation for Research and Education: www.tsfre.org

AATS Resident Resources: www.aats.org/TSR/index.html

CTSNET Residents Section: www.ctsnet.org/sections/residents

Thoracic Surgery Directors Association: www.tsda.org

Thoracic Surgery News: www.thoracicsurgerynews.com

Thoracic Surgery Residents Association: www.tsranet.org

Thoracic Surgery Foundation for Research and Education: www.tsfre.org

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