User login
Official Newspaper of the American College of Surgeons
Pain scores point to hospital quality in colorectal surgery
Post-surgical pain scores may be an overlooked quality indicator among hospitals, according to new research linking patient-reported pain scores with institutional pain management practices and also surgical outcomes.
A retrospective cohort study of patient-reported pain scores after colorectal resections at 52 Michigan hospitals, published in Annals of Surgery (2016 Jan 7; epub ahead of print; doi: 10.1097/SLA.0000000000001541), found that patients treated at the best-performing hospitals for postoperative pain scores were more likely to have received patient-controlled analgesia, compared with those in the worst-performing ones (56.5% vs. 22.8%; P less than .001).
For their research, Dr. Scott E. Regenbogen of the University of Michigan, Ann Arbor, and his colleagues looked at patient-reported pain scores on the first morning post-surgery for 7,221 colorectal operations between 2012 and 2014. The participating hospitals were part of a statewide collaborative that collects data on surgery patients with the aim of improving quality.
Dr. Regenbogen and his colleagues found that patients in the quartile of hospitals with the best pain scores stayed fewer days (6.5 vs. 7.9, P less than .007) and had fewer post-surgical complications (20.3% vs. 26.4%; P less than .001), compared with those in the worst-performing quartile of hospitals.
In addition, Dr. Regenbogen and his colleagues found postoperative emergency department visits, readmissions, and pulmonary complications to be significantly lower in the quartile of hospitals with the best pain scores. The fewer pulmonary complications seen linked with better pain control “could be an indicator of better pulmonary toilet or lesser respiratory depression,” they noted.
The correlation between surgical outcomes and pain scores, the investigators wrote, suggests “consistency in the overall quality performance across both clinical and patient-reported outcomes for colectomy.”
Mean self-rated pain scores, in which patients characterize the intensity of their pain on a scale of 0 to 10, ranged from 4 to 6 across the hospitals in the study, with 5.1 (standard deviation 2.44) reported for the cohort as a whole. The type of surgery also affected pain scores, with minimally invasive procedures associated with lower scores, compared with open or converted procedures. The type of anesthesia used (local or epidural) also significantly affected scores.
Hospitals with better pain scores tended to be somewhat larger than those with poor scores, and performed more colorectal resections per year, the investigators found.
The researchers noted that while a previous meta-analysis showed that patient-controlled analgesia post-surgery provided superior pain control, compared with intermittent treatment (Cochrane Database Syst Rev. 2006 Oct 18;18:CD003348), the hospitals in this study varied widely in their approaches, with 89% of the poorly performing quartile of hospitals using intermittent parenteral narcotics, compared with 66% in the best-performing quartile.
Dr. Regenbogen and his colleagues noted in their analysis that it was possible that the association between pain control and clinical outcomes such as readmissions and complications was driven by case or patient complexity differences among institutions. The 52 hospitals in the study varied in size and type, with community and academic hospitals as well as rural and urban institutions represented.
However, they wrote, it is more likely that “both pain scores and clinical outcomes reflect … global features of the quality of care in hospitals’ surgical performance. Thus, hospitals with the most streamlined, high-quality perioperative care pathways experience the best pain scores, as well as improved clinical outcomes.”
The findings, they concluded, “reveal systematic clinical care variation that could be reduced to improve patients’ experience of pain after colorectal resections.”
The researchers noted as a limitation of the study its reliance on patient-reported pain measures, and that it did not include data on patients’ pain history, opioid use prior to admission, or the administration of pre-emptive analgesia before surgery. The study was funded by the Michigan Surgical Quality Collaborative, which receives support from Blue Cross Blue Shield. None of the study authors declared conflicts of interest.
Post-surgical pain scores may be an overlooked quality indicator among hospitals, according to new research linking patient-reported pain scores with institutional pain management practices and also surgical outcomes.
A retrospective cohort study of patient-reported pain scores after colorectal resections at 52 Michigan hospitals, published in Annals of Surgery (2016 Jan 7; epub ahead of print; doi: 10.1097/SLA.0000000000001541), found that patients treated at the best-performing hospitals for postoperative pain scores were more likely to have received patient-controlled analgesia, compared with those in the worst-performing ones (56.5% vs. 22.8%; P less than .001).
For their research, Dr. Scott E. Regenbogen of the University of Michigan, Ann Arbor, and his colleagues looked at patient-reported pain scores on the first morning post-surgery for 7,221 colorectal operations between 2012 and 2014. The participating hospitals were part of a statewide collaborative that collects data on surgery patients with the aim of improving quality.
Dr. Regenbogen and his colleagues found that patients in the quartile of hospitals with the best pain scores stayed fewer days (6.5 vs. 7.9, P less than .007) and had fewer post-surgical complications (20.3% vs. 26.4%; P less than .001), compared with those in the worst-performing quartile of hospitals.
In addition, Dr. Regenbogen and his colleagues found postoperative emergency department visits, readmissions, and pulmonary complications to be significantly lower in the quartile of hospitals with the best pain scores. The fewer pulmonary complications seen linked with better pain control “could be an indicator of better pulmonary toilet or lesser respiratory depression,” they noted.
The correlation between surgical outcomes and pain scores, the investigators wrote, suggests “consistency in the overall quality performance across both clinical and patient-reported outcomes for colectomy.”
Mean self-rated pain scores, in which patients characterize the intensity of their pain on a scale of 0 to 10, ranged from 4 to 6 across the hospitals in the study, with 5.1 (standard deviation 2.44) reported for the cohort as a whole. The type of surgery also affected pain scores, with minimally invasive procedures associated with lower scores, compared with open or converted procedures. The type of anesthesia used (local or epidural) also significantly affected scores.
Hospitals with better pain scores tended to be somewhat larger than those with poor scores, and performed more colorectal resections per year, the investigators found.
The researchers noted that while a previous meta-analysis showed that patient-controlled analgesia post-surgery provided superior pain control, compared with intermittent treatment (Cochrane Database Syst Rev. 2006 Oct 18;18:CD003348), the hospitals in this study varied widely in their approaches, with 89% of the poorly performing quartile of hospitals using intermittent parenteral narcotics, compared with 66% in the best-performing quartile.
Dr. Regenbogen and his colleagues noted in their analysis that it was possible that the association between pain control and clinical outcomes such as readmissions and complications was driven by case or patient complexity differences among institutions. The 52 hospitals in the study varied in size and type, with community and academic hospitals as well as rural and urban institutions represented.
However, they wrote, it is more likely that “both pain scores and clinical outcomes reflect … global features of the quality of care in hospitals’ surgical performance. Thus, hospitals with the most streamlined, high-quality perioperative care pathways experience the best pain scores, as well as improved clinical outcomes.”
The findings, they concluded, “reveal systematic clinical care variation that could be reduced to improve patients’ experience of pain after colorectal resections.”
The researchers noted as a limitation of the study its reliance on patient-reported pain measures, and that it did not include data on patients’ pain history, opioid use prior to admission, or the administration of pre-emptive analgesia before surgery. The study was funded by the Michigan Surgical Quality Collaborative, which receives support from Blue Cross Blue Shield. None of the study authors declared conflicts of interest.
Post-surgical pain scores may be an overlooked quality indicator among hospitals, according to new research linking patient-reported pain scores with institutional pain management practices and also surgical outcomes.
A retrospective cohort study of patient-reported pain scores after colorectal resections at 52 Michigan hospitals, published in Annals of Surgery (2016 Jan 7; epub ahead of print; doi: 10.1097/SLA.0000000000001541), found that patients treated at the best-performing hospitals for postoperative pain scores were more likely to have received patient-controlled analgesia, compared with those in the worst-performing ones (56.5% vs. 22.8%; P less than .001).
For their research, Dr. Scott E. Regenbogen of the University of Michigan, Ann Arbor, and his colleagues looked at patient-reported pain scores on the first morning post-surgery for 7,221 colorectal operations between 2012 and 2014. The participating hospitals were part of a statewide collaborative that collects data on surgery patients with the aim of improving quality.
Dr. Regenbogen and his colleagues found that patients in the quartile of hospitals with the best pain scores stayed fewer days (6.5 vs. 7.9, P less than .007) and had fewer post-surgical complications (20.3% vs. 26.4%; P less than .001), compared with those in the worst-performing quartile of hospitals.
In addition, Dr. Regenbogen and his colleagues found postoperative emergency department visits, readmissions, and pulmonary complications to be significantly lower in the quartile of hospitals with the best pain scores. The fewer pulmonary complications seen linked with better pain control “could be an indicator of better pulmonary toilet or lesser respiratory depression,” they noted.
The correlation between surgical outcomes and pain scores, the investigators wrote, suggests “consistency in the overall quality performance across both clinical and patient-reported outcomes for colectomy.”
Mean self-rated pain scores, in which patients characterize the intensity of their pain on a scale of 0 to 10, ranged from 4 to 6 across the hospitals in the study, with 5.1 (standard deviation 2.44) reported for the cohort as a whole. The type of surgery also affected pain scores, with minimally invasive procedures associated with lower scores, compared with open or converted procedures. The type of anesthesia used (local or epidural) also significantly affected scores.
Hospitals with better pain scores tended to be somewhat larger than those with poor scores, and performed more colorectal resections per year, the investigators found.
The researchers noted that while a previous meta-analysis showed that patient-controlled analgesia post-surgery provided superior pain control, compared with intermittent treatment (Cochrane Database Syst Rev. 2006 Oct 18;18:CD003348), the hospitals in this study varied widely in their approaches, with 89% of the poorly performing quartile of hospitals using intermittent parenteral narcotics, compared with 66% in the best-performing quartile.
Dr. Regenbogen and his colleagues noted in their analysis that it was possible that the association between pain control and clinical outcomes such as readmissions and complications was driven by case or patient complexity differences among institutions. The 52 hospitals in the study varied in size and type, with community and academic hospitals as well as rural and urban institutions represented.
However, they wrote, it is more likely that “both pain scores and clinical outcomes reflect … global features of the quality of care in hospitals’ surgical performance. Thus, hospitals with the most streamlined, high-quality perioperative care pathways experience the best pain scores, as well as improved clinical outcomes.”
The findings, they concluded, “reveal systematic clinical care variation that could be reduced to improve patients’ experience of pain after colorectal resections.”
The researchers noted as a limitation of the study its reliance on patient-reported pain measures, and that it did not include data on patients’ pain history, opioid use prior to admission, or the administration of pre-emptive analgesia before surgery. The study was funded by the Michigan Surgical Quality Collaborative, which receives support from Blue Cross Blue Shield. None of the study authors declared conflicts of interest.
FROM ANNALS OF SURGERY
Key clinical point: Hospitals delivering better patient-reported pain control after colorectal resection also saw better surgical outcomes.
Major finding: Patients in the quartile of hospitals with the best pain scores stayed fewer days (6.5 vs. 7.9, P less than .007) and had fewer post-surgical complications (20.3% vs. 26.4%; P less than .001), compared with those in the worst-performing quartile of hospitals.
Data source: A retrospective cohort study reviewing more than 7,000 colorectal resections at 52 Michigan hospitals between 2012 and 2014.
Disclosures: The Michigan Surgical Quality Collaborative, funded by Blue Cross Blue Shield, sponsored the study. Investigators declared no conflicts of interest.
Majority of state exchanges exclude bariatric coverage
The majority of state exchanges are not covering bariatric surgery for 2015-2016, but one state is set to make the switch to limited coverage in 2017, according to the American Society for Metabolic and Bariatric Surgery.
There are currently 28 states with benchmark plans on their insurance exchanges that exclude coverage of bariatric surgery, but Colorado will add coverage for bariatric surgery when it replaces the state’s current essential health benefits benchmark for 2017, the ASMBS reported.
Among the states not covering bariatric surgery are Texas, Florida, Ohio, and Pennsylvania. Those that do have coverage on their state exchanges include California, New York, and Illinois, the ASMBS noted. Four states – California, New Mexico, Massachusetts, and Michigan – and the District of Columbia have benchmark plans that cover weight-loss programs.
The ASMBS said that “state health exchange plans continue to utilize blanket exclusions for weight loss programs or any obesity management services [even though] such blanket exclusions for these services are contradictory to ACA-mandated coverage for [U.S. Preventive Services Task Force] recommended preventive services.”
Meanwhile, the society added, the U.S. Department of Health & Human Services “continues to sidestep its oversight authority in favor of letting states work out these issues – instructing advocates to contact state insurance commissioners for any kind of recourse.”
The majority of state exchanges are not covering bariatric surgery for 2015-2016, but one state is set to make the switch to limited coverage in 2017, according to the American Society for Metabolic and Bariatric Surgery.
There are currently 28 states with benchmark plans on their insurance exchanges that exclude coverage of bariatric surgery, but Colorado will add coverage for bariatric surgery when it replaces the state’s current essential health benefits benchmark for 2017, the ASMBS reported.
Among the states not covering bariatric surgery are Texas, Florida, Ohio, and Pennsylvania. Those that do have coverage on their state exchanges include California, New York, and Illinois, the ASMBS noted. Four states – California, New Mexico, Massachusetts, and Michigan – and the District of Columbia have benchmark plans that cover weight-loss programs.
The ASMBS said that “state health exchange plans continue to utilize blanket exclusions for weight loss programs or any obesity management services [even though] such blanket exclusions for these services are contradictory to ACA-mandated coverage for [U.S. Preventive Services Task Force] recommended preventive services.”
Meanwhile, the society added, the U.S. Department of Health & Human Services “continues to sidestep its oversight authority in favor of letting states work out these issues – instructing advocates to contact state insurance commissioners for any kind of recourse.”
The majority of state exchanges are not covering bariatric surgery for 2015-2016, but one state is set to make the switch to limited coverage in 2017, according to the American Society for Metabolic and Bariatric Surgery.
There are currently 28 states with benchmark plans on their insurance exchanges that exclude coverage of bariatric surgery, but Colorado will add coverage for bariatric surgery when it replaces the state’s current essential health benefits benchmark for 2017, the ASMBS reported.
Among the states not covering bariatric surgery are Texas, Florida, Ohio, and Pennsylvania. Those that do have coverage on their state exchanges include California, New York, and Illinois, the ASMBS noted. Four states – California, New Mexico, Massachusetts, and Michigan – and the District of Columbia have benchmark plans that cover weight-loss programs.
The ASMBS said that “state health exchange plans continue to utilize blanket exclusions for weight loss programs or any obesity management services [even though] such blanket exclusions for these services are contradictory to ACA-mandated coverage for [U.S. Preventive Services Task Force] recommended preventive services.”
Meanwhile, the society added, the U.S. Department of Health & Human Services “continues to sidestep its oversight authority in favor of letting states work out these issues – instructing advocates to contact state insurance commissioners for any kind of recourse.”
Study: Pay one malpractice claim, expect second
If you pay a medical malpractice claim once, chances are you’ll pay a second claim in the future, according to a study published Jan. 28 in the New England Journal of Medicine (doi: 10.1056/NEJMsa1506137).
David M. Studdert Sc.D., of Stanford (Calif.) University and his colleagues analyzed 66,426 malpractice claims from the National Practitioner Data Bank that were paid against 54,099 physicians between 2005 through 2014. Investigators calculated the cumulative distribution of paid claims in two physician populations: U.S. doctors with one or more paid claims and all active U.S. physicians.
Of all paid claims, 82% involved male physicians. The specialists with the most paid claims were internists (15%), ob.gyns. (13%), general surgeons (12%), and family physicians (11%). Only 3% of the lawsuits were paid through trial verdicts. The remaining claims were paid by out-of-court settlements. The mean payment amount for claims was $371,054, while the median was $204,750.
When using all 915,564 active U.S. physicians as a denominator, only 6% of physicians had a paid claim against them and about 1% had at least two paid claims against them. When looking at physicians with at least one paid claim, 84% had only one paid claim over the study period, accounting for 68% of all paid claims. However, 16% (8,846 physicians) had at least two paid claims, accounting for 32% of all claims. A total of 4% of doctors (2,160 physicians) had at least three paid claims and accounted for 12% of all claims, and 1% (722 physicians) had at least four paid claims and accounted for 5% of all claims.
Specialties had a marked impact on the risk of future paid claims. Compared with internists, the risk of recurrence was double among neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, and ob.gyns. Psychiatrists and pediatricians had the lowest risks of recurrence.
Mr. Studdert said that the investigators were surprised to learn the degree to which past paid claims predicted future claims.
“I think if you ask most people who work in the liability insurance industry, they would tell you that’s probably true,” he said in an interview. “But I don’ t think we’ve seen – at least not on this scale – research finding just how sharply claim risk rises with malpractice history. It does suggest for those multiclaim physicians, that there is something going on that is predisposing them to be the subject of malpractice litigation.”
He noted the analysis suggests that it is feasible to predict which physicians are at higher risk for future claims. The information could then be used to develop interventions to address malpractice claims.
“These multiclaim physicians do appear to have some distinctive characteristics, and that gives us some optimism that it might be possible to predict who is going to [become] a multiclaim physician,” Mr. Studdert said. “More work is needed to make sure that’s technically feasible, but if it is, that opens up a lot of possibilities for liability insurers, hospitals ,medical boards, and other regulators to use this information proactively rather than just reacting to events after they happen.”
On Twitter @legal_med
If you pay a medical malpractice claim once, chances are you’ll pay a second claim in the future, according to a study published Jan. 28 in the New England Journal of Medicine (doi: 10.1056/NEJMsa1506137).
David M. Studdert Sc.D., of Stanford (Calif.) University and his colleagues analyzed 66,426 malpractice claims from the National Practitioner Data Bank that were paid against 54,099 physicians between 2005 through 2014. Investigators calculated the cumulative distribution of paid claims in two physician populations: U.S. doctors with one or more paid claims and all active U.S. physicians.
Of all paid claims, 82% involved male physicians. The specialists with the most paid claims were internists (15%), ob.gyns. (13%), general surgeons (12%), and family physicians (11%). Only 3% of the lawsuits were paid through trial verdicts. The remaining claims were paid by out-of-court settlements. The mean payment amount for claims was $371,054, while the median was $204,750.
When using all 915,564 active U.S. physicians as a denominator, only 6% of physicians had a paid claim against them and about 1% had at least two paid claims against them. When looking at physicians with at least one paid claim, 84% had only one paid claim over the study period, accounting for 68% of all paid claims. However, 16% (8,846 physicians) had at least two paid claims, accounting for 32% of all claims. A total of 4% of doctors (2,160 physicians) had at least three paid claims and accounted for 12% of all claims, and 1% (722 physicians) had at least four paid claims and accounted for 5% of all claims.
Specialties had a marked impact on the risk of future paid claims. Compared with internists, the risk of recurrence was double among neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, and ob.gyns. Psychiatrists and pediatricians had the lowest risks of recurrence.
Mr. Studdert said that the investigators were surprised to learn the degree to which past paid claims predicted future claims.
“I think if you ask most people who work in the liability insurance industry, they would tell you that’s probably true,” he said in an interview. “But I don’ t think we’ve seen – at least not on this scale – research finding just how sharply claim risk rises with malpractice history. It does suggest for those multiclaim physicians, that there is something going on that is predisposing them to be the subject of malpractice litigation.”
He noted the analysis suggests that it is feasible to predict which physicians are at higher risk for future claims. The information could then be used to develop interventions to address malpractice claims.
“These multiclaim physicians do appear to have some distinctive characteristics, and that gives us some optimism that it might be possible to predict who is going to [become] a multiclaim physician,” Mr. Studdert said. “More work is needed to make sure that’s technically feasible, but if it is, that opens up a lot of possibilities for liability insurers, hospitals ,medical boards, and other regulators to use this information proactively rather than just reacting to events after they happen.”
On Twitter @legal_med
If you pay a medical malpractice claim once, chances are you’ll pay a second claim in the future, according to a study published Jan. 28 in the New England Journal of Medicine (doi: 10.1056/NEJMsa1506137).
David M. Studdert Sc.D., of Stanford (Calif.) University and his colleagues analyzed 66,426 malpractice claims from the National Practitioner Data Bank that were paid against 54,099 physicians between 2005 through 2014. Investigators calculated the cumulative distribution of paid claims in two physician populations: U.S. doctors with one or more paid claims and all active U.S. physicians.
Of all paid claims, 82% involved male physicians. The specialists with the most paid claims were internists (15%), ob.gyns. (13%), general surgeons (12%), and family physicians (11%). Only 3% of the lawsuits were paid through trial verdicts. The remaining claims were paid by out-of-court settlements. The mean payment amount for claims was $371,054, while the median was $204,750.
When using all 915,564 active U.S. physicians as a denominator, only 6% of physicians had a paid claim against them and about 1% had at least two paid claims against them. When looking at physicians with at least one paid claim, 84% had only one paid claim over the study period, accounting for 68% of all paid claims. However, 16% (8,846 physicians) had at least two paid claims, accounting for 32% of all claims. A total of 4% of doctors (2,160 physicians) had at least three paid claims and accounted for 12% of all claims, and 1% (722 physicians) had at least four paid claims and accounted for 5% of all claims.
Specialties had a marked impact on the risk of future paid claims. Compared with internists, the risk of recurrence was double among neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, and ob.gyns. Psychiatrists and pediatricians had the lowest risks of recurrence.
Mr. Studdert said that the investigators were surprised to learn the degree to which past paid claims predicted future claims.
“I think if you ask most people who work in the liability insurance industry, they would tell you that’s probably true,” he said in an interview. “But I don’ t think we’ve seen – at least not on this scale – research finding just how sharply claim risk rises with malpractice history. It does suggest for those multiclaim physicians, that there is something going on that is predisposing them to be the subject of malpractice litigation.”
He noted the analysis suggests that it is feasible to predict which physicians are at higher risk for future claims. The information could then be used to develop interventions to address malpractice claims.
“These multiclaim physicians do appear to have some distinctive characteristics, and that gives us some optimism that it might be possible to predict who is going to [become] a multiclaim physician,” Mr. Studdert said. “More work is needed to make sure that’s technically feasible, but if it is, that opens up a lot of possibilities for liability insurers, hospitals ,medical boards, and other regulators to use this information proactively rather than just reacting to events after they happen.”
On Twitter @legal_med
Key clinical point: Doctors with one paid medical malpractice claim have a greater chance of future paid claims.
Major finding: Of 54,099 physicians with at least one paid claim,16% had at least two paid claims. Physicians with two paid claims had almost twice the risk of having another paid claim compared with doctors who had only one paid claim against them.
Data source: Analysis of the National Practitioner Data Bank.
Disclosures: David Studdert, Sc.D., and Michelle Mello, Ph.D., reported grant support from the Risk Authority outside of this study.
Hernia repair: Studies don’t support use of higher-cost biological mesh
The jury is still out on the costs and efficacy of biological mesh implants for abdominal wall hernia repair, according to a systematic review of the literature.
Of 20 articles that met search criteria, only 3 were comparative studies and none was a randomized clinical trial. In fact, most were case series involving convenience samples of patients at single institutions, Dr. Sergio Huerta of the University of Texas Southwestern Medical Center, Dallas, and his colleagues reported online Jan. 27 in JAMA Surgery.
The authors used multiple electronic databases to identify articles published between 1948 and June 30, 2015, on the use of biological mesh materials for reinforcement of the abdominal wall for hernia repair. Included were 14 articles that described outcomes with human acellular dermal matrix, 2 that reported results for porcine collagen intestinal submucosa derivatives, 3 that reported on porcine acelluar collagen skin derivatives, and 1 that described results for bovine pericardium.
Several problems were noted with respect to the studies, including widely varying follow-up time, operative technique, types of mesh used, and patient selection criteria. Also, outcome measures were not reported consistently across studies.
In addition, 16 of the 20 studies that met search criteria did not report investigator conflicts of interest, the authors reported (JAMA Surg. 2016 Jan 27. doi: 10.10001/jamasurg.2015.5234).
Notably, all the meshes used in the studies were approved by the Food and Drug Administration and were considered to be comparable to a group of nonbiological predicate devices, which cost up to 25% less than the biological equivalents, they noted.
“We were unable to find any evidence that supported the use of expensive biological material relative to low-cost synthetic mesh. In fact, with one exception, the biological materials became commercially available by showing that these materials were equivalent to low-cost established synthetic mesh material in an FDA 510(k) approval process. This process does not require phase 0 through IV clinical trials as required for drugs or biological agents,” they wrote, noting that the one material that bypassed the 510(k) process (Alloderm) was not required to demonstrate equivalence because it was classified as human transplanted tissue.
Biological mesh materials were introduced in the 1990s to minimize the risk of complications commonly seen with the use of synthetic mesh for abdominal wall hernia repair – one of the most common procedures performed by general surgeons, the authors explained.
“Because the outcomes for biological mesh material are perceived to be better than those for polymer-based prosthetic mesh replacement materials, the use of biological grafts increased exponentially without clear clinical evidence of efficacy,” they wrote.
The current review suggests that the evidence remains insufficient to determine whether cost and clinical benefits exist.
“It is generally assumed that FDA-approved drug or biological agents have been rigorously evaluated and that there is demonstrable safety and efficacy. This is not the case for 510(k) medical devices. Before using a new medical device, physicians should know the approval basis for the device and recognize that if it is a 510(k) device neither safety nor efficacy is ensured,” they said, adding that physicians should assume such devices are no better than predicate devices to which they are equivalent, and that “there can be no justification for purchasing a more expensive device when a lower-cost predicate device, which is equivalent, is available.”
Though limited by certain factors such as lack of access to detailed FDA information such as the specific criteria used to determine equivalence, and a lack of published literature on the full market penetration of biological mesh materials vs. nonbiological counterparts, the authors maintained that until evidence demonstrates superiority of biological materials, the expense associated with their use cannot be justified.
This study was supported by the Hudson-Penn Endowment fund at the University of Texas Southwestern Medical Center. The authors reported having no relevant financial disclosures.
Balancing the need for innovation against the practicalities of demonstrating clinical benefit for novel ideas is a fundamental problem in surgery – a problem highlighted by Heurta et al., Dr. Benjamin K. Poulose and his colleagues said in an editorial.
“This issue is particularly timely given an unsustainable trajectory of health care spending in the United States,” they wrote (JAMA Surg 2016 Jan 27. doi: 10.1001/jamasurg2015.5236).
Like the authors of the literature review, the editorial authors stressed the importance of understanding the limitations of the 510(k) process, and noted that surgeons should consider that the FDA sees them as “the group responsible for understanding and evaluating the data before using expensive medical devices.
“Understanding who is in charge of making sure that the devices that we use during surgery are safe and effective is critical. Likely, it will require a collaborative effort of the FDA, medical device companies, and physicians,” they wrote. Establishing a more formal system of postmarketing surveillance for higher-risk medical devices will benefit patients, they added. Current efforts suffer from reliance on self-reporting and lack of standardized data collection.
Postmarketing surveillance can be greatly improved by directly linking medical device approval with the support of high-quality registries, and the end result should provide transparent data for monitoring effectiveness and safety to drive value-based care and maintain innovation, they said.
Dr. Poulose is with Vanderbilt University Medical Center, Nashville, Tenn. Dr. Poulose reported receiving personal fees from Ariste Medical for consulting work, and research grants from Bard-Davol outside the submitted work.
Balancing the need for innovation against the practicalities of demonstrating clinical benefit for novel ideas is a fundamental problem in surgery – a problem highlighted by Heurta et al., Dr. Benjamin K. Poulose and his colleagues said in an editorial.
“This issue is particularly timely given an unsustainable trajectory of health care spending in the United States,” they wrote (JAMA Surg 2016 Jan 27. doi: 10.1001/jamasurg2015.5236).
Like the authors of the literature review, the editorial authors stressed the importance of understanding the limitations of the 510(k) process, and noted that surgeons should consider that the FDA sees them as “the group responsible for understanding and evaluating the data before using expensive medical devices.
“Understanding who is in charge of making sure that the devices that we use during surgery are safe and effective is critical. Likely, it will require a collaborative effort of the FDA, medical device companies, and physicians,” they wrote. Establishing a more formal system of postmarketing surveillance for higher-risk medical devices will benefit patients, they added. Current efforts suffer from reliance on self-reporting and lack of standardized data collection.
Postmarketing surveillance can be greatly improved by directly linking medical device approval with the support of high-quality registries, and the end result should provide transparent data for monitoring effectiveness and safety to drive value-based care and maintain innovation, they said.
Dr. Poulose is with Vanderbilt University Medical Center, Nashville, Tenn. Dr. Poulose reported receiving personal fees from Ariste Medical for consulting work, and research grants from Bard-Davol outside the submitted work.
Balancing the need for innovation against the practicalities of demonstrating clinical benefit for novel ideas is a fundamental problem in surgery – a problem highlighted by Heurta et al., Dr. Benjamin K. Poulose and his colleagues said in an editorial.
“This issue is particularly timely given an unsustainable trajectory of health care spending in the United States,” they wrote (JAMA Surg 2016 Jan 27. doi: 10.1001/jamasurg2015.5236).
Like the authors of the literature review, the editorial authors stressed the importance of understanding the limitations of the 510(k) process, and noted that surgeons should consider that the FDA sees them as “the group responsible for understanding and evaluating the data before using expensive medical devices.
“Understanding who is in charge of making sure that the devices that we use during surgery are safe and effective is critical. Likely, it will require a collaborative effort of the FDA, medical device companies, and physicians,” they wrote. Establishing a more formal system of postmarketing surveillance for higher-risk medical devices will benefit patients, they added. Current efforts suffer from reliance on self-reporting and lack of standardized data collection.
Postmarketing surveillance can be greatly improved by directly linking medical device approval with the support of high-quality registries, and the end result should provide transparent data for monitoring effectiveness and safety to drive value-based care and maintain innovation, they said.
Dr. Poulose is with Vanderbilt University Medical Center, Nashville, Tenn. Dr. Poulose reported receiving personal fees from Ariste Medical for consulting work, and research grants from Bard-Davol outside the submitted work.
The jury is still out on the costs and efficacy of biological mesh implants for abdominal wall hernia repair, according to a systematic review of the literature.
Of 20 articles that met search criteria, only 3 were comparative studies and none was a randomized clinical trial. In fact, most were case series involving convenience samples of patients at single institutions, Dr. Sergio Huerta of the University of Texas Southwestern Medical Center, Dallas, and his colleagues reported online Jan. 27 in JAMA Surgery.
The authors used multiple electronic databases to identify articles published between 1948 and June 30, 2015, on the use of biological mesh materials for reinforcement of the abdominal wall for hernia repair. Included were 14 articles that described outcomes with human acellular dermal matrix, 2 that reported results for porcine collagen intestinal submucosa derivatives, 3 that reported on porcine acelluar collagen skin derivatives, and 1 that described results for bovine pericardium.
Several problems were noted with respect to the studies, including widely varying follow-up time, operative technique, types of mesh used, and patient selection criteria. Also, outcome measures were not reported consistently across studies.
In addition, 16 of the 20 studies that met search criteria did not report investigator conflicts of interest, the authors reported (JAMA Surg. 2016 Jan 27. doi: 10.10001/jamasurg.2015.5234).
Notably, all the meshes used in the studies were approved by the Food and Drug Administration and were considered to be comparable to a group of nonbiological predicate devices, which cost up to 25% less than the biological equivalents, they noted.
“We were unable to find any evidence that supported the use of expensive biological material relative to low-cost synthetic mesh. In fact, with one exception, the biological materials became commercially available by showing that these materials were equivalent to low-cost established synthetic mesh material in an FDA 510(k) approval process. This process does not require phase 0 through IV clinical trials as required for drugs or biological agents,” they wrote, noting that the one material that bypassed the 510(k) process (Alloderm) was not required to demonstrate equivalence because it was classified as human transplanted tissue.
Biological mesh materials were introduced in the 1990s to minimize the risk of complications commonly seen with the use of synthetic mesh for abdominal wall hernia repair – one of the most common procedures performed by general surgeons, the authors explained.
“Because the outcomes for biological mesh material are perceived to be better than those for polymer-based prosthetic mesh replacement materials, the use of biological grafts increased exponentially without clear clinical evidence of efficacy,” they wrote.
The current review suggests that the evidence remains insufficient to determine whether cost and clinical benefits exist.
“It is generally assumed that FDA-approved drug or biological agents have been rigorously evaluated and that there is demonstrable safety and efficacy. This is not the case for 510(k) medical devices. Before using a new medical device, physicians should know the approval basis for the device and recognize that if it is a 510(k) device neither safety nor efficacy is ensured,” they said, adding that physicians should assume such devices are no better than predicate devices to which they are equivalent, and that “there can be no justification for purchasing a more expensive device when a lower-cost predicate device, which is equivalent, is available.”
Though limited by certain factors such as lack of access to detailed FDA information such as the specific criteria used to determine equivalence, and a lack of published literature on the full market penetration of biological mesh materials vs. nonbiological counterparts, the authors maintained that until evidence demonstrates superiority of biological materials, the expense associated with their use cannot be justified.
This study was supported by the Hudson-Penn Endowment fund at the University of Texas Southwestern Medical Center. The authors reported having no relevant financial disclosures.
The jury is still out on the costs and efficacy of biological mesh implants for abdominal wall hernia repair, according to a systematic review of the literature.
Of 20 articles that met search criteria, only 3 were comparative studies and none was a randomized clinical trial. In fact, most were case series involving convenience samples of patients at single institutions, Dr. Sergio Huerta of the University of Texas Southwestern Medical Center, Dallas, and his colleagues reported online Jan. 27 in JAMA Surgery.
The authors used multiple electronic databases to identify articles published between 1948 and June 30, 2015, on the use of biological mesh materials for reinforcement of the abdominal wall for hernia repair. Included were 14 articles that described outcomes with human acellular dermal matrix, 2 that reported results for porcine collagen intestinal submucosa derivatives, 3 that reported on porcine acelluar collagen skin derivatives, and 1 that described results for bovine pericardium.
Several problems were noted with respect to the studies, including widely varying follow-up time, operative technique, types of mesh used, and patient selection criteria. Also, outcome measures were not reported consistently across studies.
In addition, 16 of the 20 studies that met search criteria did not report investigator conflicts of interest, the authors reported (JAMA Surg. 2016 Jan 27. doi: 10.10001/jamasurg.2015.5234).
Notably, all the meshes used in the studies were approved by the Food and Drug Administration and were considered to be comparable to a group of nonbiological predicate devices, which cost up to 25% less than the biological equivalents, they noted.
“We were unable to find any evidence that supported the use of expensive biological material relative to low-cost synthetic mesh. In fact, with one exception, the biological materials became commercially available by showing that these materials were equivalent to low-cost established synthetic mesh material in an FDA 510(k) approval process. This process does not require phase 0 through IV clinical trials as required for drugs or biological agents,” they wrote, noting that the one material that bypassed the 510(k) process (Alloderm) was not required to demonstrate equivalence because it was classified as human transplanted tissue.
Biological mesh materials were introduced in the 1990s to minimize the risk of complications commonly seen with the use of synthetic mesh for abdominal wall hernia repair – one of the most common procedures performed by general surgeons, the authors explained.
“Because the outcomes for biological mesh material are perceived to be better than those for polymer-based prosthetic mesh replacement materials, the use of biological grafts increased exponentially without clear clinical evidence of efficacy,” they wrote.
The current review suggests that the evidence remains insufficient to determine whether cost and clinical benefits exist.
“It is generally assumed that FDA-approved drug or biological agents have been rigorously evaluated and that there is demonstrable safety and efficacy. This is not the case for 510(k) medical devices. Before using a new medical device, physicians should know the approval basis for the device and recognize that if it is a 510(k) device neither safety nor efficacy is ensured,” they said, adding that physicians should assume such devices are no better than predicate devices to which they are equivalent, and that “there can be no justification for purchasing a more expensive device when a lower-cost predicate device, which is equivalent, is available.”
Though limited by certain factors such as lack of access to detailed FDA information such as the specific criteria used to determine equivalence, and a lack of published literature on the full market penetration of biological mesh materials vs. nonbiological counterparts, the authors maintained that until evidence demonstrates superiority of biological materials, the expense associated with their use cannot be justified.
This study was supported by the Hudson-Penn Endowment fund at the University of Texas Southwestern Medical Center. The authors reported having no relevant financial disclosures.
FROM JAMA SURGERY
Key clinical point: The jury is still out on the costs and efficacy of biological mesh implants for abdominal wall hernia repair, and the expense associated with their use cannot be justified at this time, a systematic review of the literature suggested.
Major finding: Available evidence remains insufficient to determine whether cost and clinical benefits exist with the use of biological mesh for abdominal wall hernia repair.
Data source: A systematic review of the literature, yielding 20 eligible studies.
Disclosures: This study was supported by the Hudson-Penn Endowment fund at University of Texas Southwestern Medical Center. The authors reported having no relevant financial disclosures.
Level 1 activation reduces LOS, mortality in geriatric trauma
SAN ANTONIO – Automatically bumping elderly Level 2 trauma patients to Level 1 status reduced mortality and emergency department lengths of stay at Indiana University Health Methodist Hospital, Indianapolis.
Like trauma services elsewhere, the Methodist team is trying to figure out how best to handle the coming increase in elderly patients as the Baby Boom generation ages. It’s known that older trauma patients tend to be undertriaged. To improve the situation, “we need to respond quickly with a lot of resources up front so we don’t delay diagnosis” and treatment, said investigator Dr. Peter Hammer, assistant professor of surgery at Indiana University, Indianapolis.
The solution Methodist has tried since October 2013 is a Level 1 response to any patient aged 70 years or older who meets Level 2 criteria, regardless of vital sign stability or injury mechanism. With Level 1, trauma attendings, residents, respiratory therapists, clinical pharmacists, and others are at the bedside within 15 minutes and CT services and operating rooms are on standby, among other measures. Compared with the 1,271 patients aged 70 years or older treated in the almost 2 years before the change, the 998 treated in the year and a half afterwards were, after controlling for age, comorbidities, and injury severity scores (ISS), more likely to leave the ED in less than 2 hours (odds ratio, 1.614; 95% confidence interval, 1.088-2.394) and less likely to die (OR, 0.689, 95% CI, 0.484-0.979).
The before and after groups were similar, with a mean age of 81 years, a mean ISS of 12.2, a high comorbidity burden, and, for most, a blunt injury: 8.3% died in the before group, versus 7.6% in the after group. The shorter ED stays occurred despite a nursing staff reduction in 2014. Patients who went into cardiac arrest before arrival or died in the ED were excluded from the analysis.
“A simple, focused intervention of a higher level of trauma activation can decrease ED length of stay and in-hospital mortality in elderly trauma patients,” Dr. Hammer said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
Among many initiatives as many trauma centers gear up for aging baby boomers, others are trying age as a criteria for higher activation, too, and recent guidelines from EAST recommend a lower threshold for trauma activation for patients 65 years or older, among other steps.
With more expertise and resources to brought to bear, it’s not surprising that Level 1 patients left the ED sooner, but it’s unclear what role that played in reducing mortality. “I wouldn’t hazard [to say] that shorter lengths of stay necessarily” saved lives, Dr. Hammer said.
Before the intervention, just 4.8% of geriatric patients left the ED within 2 hours, versus 6.5% afterwards. The numbers are low because, “as in most hospitals, there are more trauma patients than beds. [Reducing ED] length or stay [remains] an ongoing project” at Methodist, and not just for the elderly. “The ED is always overcrowded come afternoon and into the evening,” Dr. Hammer said.
That’s one of the reasons management supported the project. “They like the concept of getting patients moved through quickly. We have a lot of resources in the ED, so there doesn’t seem to be much of a slowdown” with increased Level 1 activation. It probably costs more up front, “but the hope is we’ll save money on the back end with lower mortality and shorter ED stays,” he said.
The investigators had no disclosures.
SAN ANTONIO – Automatically bumping elderly Level 2 trauma patients to Level 1 status reduced mortality and emergency department lengths of stay at Indiana University Health Methodist Hospital, Indianapolis.
Like trauma services elsewhere, the Methodist team is trying to figure out how best to handle the coming increase in elderly patients as the Baby Boom generation ages. It’s known that older trauma patients tend to be undertriaged. To improve the situation, “we need to respond quickly with a lot of resources up front so we don’t delay diagnosis” and treatment, said investigator Dr. Peter Hammer, assistant professor of surgery at Indiana University, Indianapolis.
The solution Methodist has tried since October 2013 is a Level 1 response to any patient aged 70 years or older who meets Level 2 criteria, regardless of vital sign stability or injury mechanism. With Level 1, trauma attendings, residents, respiratory therapists, clinical pharmacists, and others are at the bedside within 15 minutes and CT services and operating rooms are on standby, among other measures. Compared with the 1,271 patients aged 70 years or older treated in the almost 2 years before the change, the 998 treated in the year and a half afterwards were, after controlling for age, comorbidities, and injury severity scores (ISS), more likely to leave the ED in less than 2 hours (odds ratio, 1.614; 95% confidence interval, 1.088-2.394) and less likely to die (OR, 0.689, 95% CI, 0.484-0.979).
The before and after groups were similar, with a mean age of 81 years, a mean ISS of 12.2, a high comorbidity burden, and, for most, a blunt injury: 8.3% died in the before group, versus 7.6% in the after group. The shorter ED stays occurred despite a nursing staff reduction in 2014. Patients who went into cardiac arrest before arrival or died in the ED were excluded from the analysis.
“A simple, focused intervention of a higher level of trauma activation can decrease ED length of stay and in-hospital mortality in elderly trauma patients,” Dr. Hammer said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
Among many initiatives as many trauma centers gear up for aging baby boomers, others are trying age as a criteria for higher activation, too, and recent guidelines from EAST recommend a lower threshold for trauma activation for patients 65 years or older, among other steps.
With more expertise and resources to brought to bear, it’s not surprising that Level 1 patients left the ED sooner, but it’s unclear what role that played in reducing mortality. “I wouldn’t hazard [to say] that shorter lengths of stay necessarily” saved lives, Dr. Hammer said.
Before the intervention, just 4.8% of geriatric patients left the ED within 2 hours, versus 6.5% afterwards. The numbers are low because, “as in most hospitals, there are more trauma patients than beds. [Reducing ED] length or stay [remains] an ongoing project” at Methodist, and not just for the elderly. “The ED is always overcrowded come afternoon and into the evening,” Dr. Hammer said.
That’s one of the reasons management supported the project. “They like the concept of getting patients moved through quickly. We have a lot of resources in the ED, so there doesn’t seem to be much of a slowdown” with increased Level 1 activation. It probably costs more up front, “but the hope is we’ll save money on the back end with lower mortality and shorter ED stays,” he said.
The investigators had no disclosures.
SAN ANTONIO – Automatically bumping elderly Level 2 trauma patients to Level 1 status reduced mortality and emergency department lengths of stay at Indiana University Health Methodist Hospital, Indianapolis.
Like trauma services elsewhere, the Methodist team is trying to figure out how best to handle the coming increase in elderly patients as the Baby Boom generation ages. It’s known that older trauma patients tend to be undertriaged. To improve the situation, “we need to respond quickly with a lot of resources up front so we don’t delay diagnosis” and treatment, said investigator Dr. Peter Hammer, assistant professor of surgery at Indiana University, Indianapolis.
The solution Methodist has tried since October 2013 is a Level 1 response to any patient aged 70 years or older who meets Level 2 criteria, regardless of vital sign stability or injury mechanism. With Level 1, trauma attendings, residents, respiratory therapists, clinical pharmacists, and others are at the bedside within 15 minutes and CT services and operating rooms are on standby, among other measures. Compared with the 1,271 patients aged 70 years or older treated in the almost 2 years before the change, the 998 treated in the year and a half afterwards were, after controlling for age, comorbidities, and injury severity scores (ISS), more likely to leave the ED in less than 2 hours (odds ratio, 1.614; 95% confidence interval, 1.088-2.394) and less likely to die (OR, 0.689, 95% CI, 0.484-0.979).
The before and after groups were similar, with a mean age of 81 years, a mean ISS of 12.2, a high comorbidity burden, and, for most, a blunt injury: 8.3% died in the before group, versus 7.6% in the after group. The shorter ED stays occurred despite a nursing staff reduction in 2014. Patients who went into cardiac arrest before arrival or died in the ED were excluded from the analysis.
“A simple, focused intervention of a higher level of trauma activation can decrease ED length of stay and in-hospital mortality in elderly trauma patients,” Dr. Hammer said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
Among many initiatives as many trauma centers gear up for aging baby boomers, others are trying age as a criteria for higher activation, too, and recent guidelines from EAST recommend a lower threshold for trauma activation for patients 65 years or older, among other steps.
With more expertise and resources to brought to bear, it’s not surprising that Level 1 patients left the ED sooner, but it’s unclear what role that played in reducing mortality. “I wouldn’t hazard [to say] that shorter lengths of stay necessarily” saved lives, Dr. Hammer said.
Before the intervention, just 4.8% of geriatric patients left the ED within 2 hours, versus 6.5% afterwards. The numbers are low because, “as in most hospitals, there are more trauma patients than beds. [Reducing ED] length or stay [remains] an ongoing project” at Methodist, and not just for the elderly. “The ED is always overcrowded come afternoon and into the evening,” Dr. Hammer said.
That’s one of the reasons management supported the project. “They like the concept of getting patients moved through quickly. We have a lot of resources in the ED, so there doesn’t seem to be much of a slowdown” with increased Level 1 activation. It probably costs more up front, “but the hope is we’ll save money on the back end with lower mortality and shorter ED stays,” he said.
The investigators had no disclosures.
AT THE EAST SCIENTIFIC ASSEMBLY
Key clinical point: Consider treating Level 2 elderly trauma patients at Level 1 status.
Major finding: The 998 Level 2 elderly trauma patients treated as Level 1, after controlling for age, comorbidities, and injury severity scores, were more likely to leave the ED in less than 2 hours and were less likely to die, compared with patients treated in the previous 2 years.
Data source: More than 2,000 trauma patients aged 70 years or older.
Disclosures: The investigators had no disclosures.
Poor adherence to quality indicators found for NSCLC surgery
PHOENIX – National adherence to quality indicators for surgery in stage I non–small cell lung cancer is suboptimal, results from a large analysis of national data suggest.
“Compliance with such guidelines is a strong predictor of long-term survival, and vigorous efforts should be instituted at the level of national societies to improve such adherence,” researchers led by Dr. Pamela P. Samson wrote in an abstract presented at the annual meeting of the Society of Thoracic Surgeons. “National organizations, including American College of Chest Physicians, the National Comprehensive Cancer Network, and the American College of Surgeons Commission on Cancer, have recommended quality standards for surgery in early-stage non–small cell lung cancer (NSCLC). The determinants and outcomes of adherence to these guidelines for early-stage lung cancer patients are largely unknown.”
Dr. Samson, a general surgery resident at Washington University in St. Louis, and her associates used the National Cancer Data Base to evaluate data from 146,908 patients undergoing surgery for clinical stage I NSCLC between 2004 and 2013. They selected the following four quality measures for evaluation: performing an anatomical pulmonary resection, surgery within 8 weeks of diagnosis, R0 resection, and evaluation of 10 or more lymph nodes. Next, the researchers fitted multivariate models to identify variables independently associated with adherence to quality measures, and created a Cox multivariate model to evaluate long-term overall survival.
Dr. Varun Puri, senior author of the study, presented the findings at the STS meeting on behalf of Dr. Samson, and discussed the findings in a video interview. The researchers found that between 2004 and 2013, nearly 100% of patients met at least one of the four recommended criteria, 95% met two, 69% met three, and 22% met all four. Sampling of 10 or more lymph nodes was the least frequently met measure, occurring in only 31% of surgical patients. Patient factors associated with a greater likelihood of receiving all four quality measures included average income in ZIP code of at least $38,000 (odds ratio, 1.20), private insurance (OR, 1.22), or having Medicare (OR, 1.16). Institutional factors associated with a greater likelihood of meeting all four quality measures included higher-volume centers, defined as treating at least 38 cases per year (OR, 1.18), or being an academic institution (OR, 1.31).
At the same time, factors associated with a lower likelihood of recommended surgical care included increasing age (per year increase, OR, 0.99) and a higher Charlson/Deyo comorbidity score (OR, 0.90 for a score of 1 and OR, 0.82 for a score of 2 or more). The strongest determinant of long-term overall survival included pathologic upstaging (HR 1.84) and meeting all four quality indicators (HR 0.39). Every additional quality met was associated with a significant reduction in overall mortality.
“We believe this study can be a starting point to draw attention to institution- and surgeon-specific practice patterns that may vary widely,” Dr. Samson said in an interview prior to the meeting. “At our own institution, we are working to decrease time to surgery, as well as implementing quality improvement measures to increase nodal sampling rates. Improving these trends nationally must start at the local level, with a tailored approach.”
Dr. Samson is currently supported by a T32 NIH training grant for research fellows in cardiothoracic surgery. Study coauthor Dr. Bryan Meyers, has received honoraria from Varian Medical Systems and is a consultant/advisory board member of Ethicon. Senior author Dr. Varun Puri is supported by NIH career awards.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
PHOENIX – National adherence to quality indicators for surgery in stage I non–small cell lung cancer is suboptimal, results from a large analysis of national data suggest.
“Compliance with such guidelines is a strong predictor of long-term survival, and vigorous efforts should be instituted at the level of national societies to improve such adherence,” researchers led by Dr. Pamela P. Samson wrote in an abstract presented at the annual meeting of the Society of Thoracic Surgeons. “National organizations, including American College of Chest Physicians, the National Comprehensive Cancer Network, and the American College of Surgeons Commission on Cancer, have recommended quality standards for surgery in early-stage non–small cell lung cancer (NSCLC). The determinants and outcomes of adherence to these guidelines for early-stage lung cancer patients are largely unknown.”
Dr. Samson, a general surgery resident at Washington University in St. Louis, and her associates used the National Cancer Data Base to evaluate data from 146,908 patients undergoing surgery for clinical stage I NSCLC between 2004 and 2013. They selected the following four quality measures for evaluation: performing an anatomical pulmonary resection, surgery within 8 weeks of diagnosis, R0 resection, and evaluation of 10 or more lymph nodes. Next, the researchers fitted multivariate models to identify variables independently associated with adherence to quality measures, and created a Cox multivariate model to evaluate long-term overall survival.
Dr. Varun Puri, senior author of the study, presented the findings at the STS meeting on behalf of Dr. Samson, and discussed the findings in a video interview. The researchers found that between 2004 and 2013, nearly 100% of patients met at least one of the four recommended criteria, 95% met two, 69% met three, and 22% met all four. Sampling of 10 or more lymph nodes was the least frequently met measure, occurring in only 31% of surgical patients. Patient factors associated with a greater likelihood of receiving all four quality measures included average income in ZIP code of at least $38,000 (odds ratio, 1.20), private insurance (OR, 1.22), or having Medicare (OR, 1.16). Institutional factors associated with a greater likelihood of meeting all four quality measures included higher-volume centers, defined as treating at least 38 cases per year (OR, 1.18), or being an academic institution (OR, 1.31).
At the same time, factors associated with a lower likelihood of recommended surgical care included increasing age (per year increase, OR, 0.99) and a higher Charlson/Deyo comorbidity score (OR, 0.90 for a score of 1 and OR, 0.82 for a score of 2 or more). The strongest determinant of long-term overall survival included pathologic upstaging (HR 1.84) and meeting all four quality indicators (HR 0.39). Every additional quality met was associated with a significant reduction in overall mortality.
“We believe this study can be a starting point to draw attention to institution- and surgeon-specific practice patterns that may vary widely,” Dr. Samson said in an interview prior to the meeting. “At our own institution, we are working to decrease time to surgery, as well as implementing quality improvement measures to increase nodal sampling rates. Improving these trends nationally must start at the local level, with a tailored approach.”
Dr. Samson is currently supported by a T32 NIH training grant for research fellows in cardiothoracic surgery. Study coauthor Dr. Bryan Meyers, has received honoraria from Varian Medical Systems and is a consultant/advisory board member of Ethicon. Senior author Dr. Varun Puri is supported by NIH career awards.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
PHOENIX – National adherence to quality indicators for surgery in stage I non–small cell lung cancer is suboptimal, results from a large analysis of national data suggest.
“Compliance with such guidelines is a strong predictor of long-term survival, and vigorous efforts should be instituted at the level of national societies to improve such adherence,” researchers led by Dr. Pamela P. Samson wrote in an abstract presented at the annual meeting of the Society of Thoracic Surgeons. “National organizations, including American College of Chest Physicians, the National Comprehensive Cancer Network, and the American College of Surgeons Commission on Cancer, have recommended quality standards for surgery in early-stage non–small cell lung cancer (NSCLC). The determinants and outcomes of adherence to these guidelines for early-stage lung cancer patients are largely unknown.”
Dr. Samson, a general surgery resident at Washington University in St. Louis, and her associates used the National Cancer Data Base to evaluate data from 146,908 patients undergoing surgery for clinical stage I NSCLC between 2004 and 2013. They selected the following four quality measures for evaluation: performing an anatomical pulmonary resection, surgery within 8 weeks of diagnosis, R0 resection, and evaluation of 10 or more lymph nodes. Next, the researchers fitted multivariate models to identify variables independently associated with adherence to quality measures, and created a Cox multivariate model to evaluate long-term overall survival.
Dr. Varun Puri, senior author of the study, presented the findings at the STS meeting on behalf of Dr. Samson, and discussed the findings in a video interview. The researchers found that between 2004 and 2013, nearly 100% of patients met at least one of the four recommended criteria, 95% met two, 69% met three, and 22% met all four. Sampling of 10 or more lymph nodes was the least frequently met measure, occurring in only 31% of surgical patients. Patient factors associated with a greater likelihood of receiving all four quality measures included average income in ZIP code of at least $38,000 (odds ratio, 1.20), private insurance (OR, 1.22), or having Medicare (OR, 1.16). Institutional factors associated with a greater likelihood of meeting all four quality measures included higher-volume centers, defined as treating at least 38 cases per year (OR, 1.18), or being an academic institution (OR, 1.31).
At the same time, factors associated with a lower likelihood of recommended surgical care included increasing age (per year increase, OR, 0.99) and a higher Charlson/Deyo comorbidity score (OR, 0.90 for a score of 1 and OR, 0.82 for a score of 2 or more). The strongest determinant of long-term overall survival included pathologic upstaging (HR 1.84) and meeting all four quality indicators (HR 0.39). Every additional quality met was associated with a significant reduction in overall mortality.
“We believe this study can be a starting point to draw attention to institution- and surgeon-specific practice patterns that may vary widely,” Dr. Samson said in an interview prior to the meeting. “At our own institution, we are working to decrease time to surgery, as well as implementing quality improvement measures to increase nodal sampling rates. Improving these trends nationally must start at the local level, with a tailored approach.”
Dr. Samson is currently supported by a T32 NIH training grant for research fellows in cardiothoracic surgery. Study coauthor Dr. Bryan Meyers, has received honoraria from Varian Medical Systems and is a consultant/advisory board member of Ethicon. Senior author Dr. Varun Puri is supported by NIH career awards.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE STS ANNUAL MEETING
Key clinical point: At the national level, compliance with core indicators for surgery in stage I NSCLC is poor.
Major finding: Between 2004 and 2013, nearly 100% of patients met at least one of four recommended criteria for evaluation of stage I NSCLC, 95% met two, 69% met three, and 22% met all four.
Data source: An analysis of 146,908 patients undergoing surgery for clinical stage I NSCLC between 2004 and 2013.
Disclosures: Dr. Samson is currently supported by a T32 NIH training grant for research fellows in cardiothoracic surgery. Study coauthor Dr. Bryan Meyers, has received honoraria from Varian Medical Systems and is a consultant/advisory board member of Ethicon. Senior author Dr. Varun Puri is supported by NIH career awards.
VIDEO: Expert discusses VATS thymectomy for myasthenia gravis
PHOENIX – In the clinical experience of Dr. Joshua R. Sonett, VATS thymectomy for myasthenia gravis is best performed in a bilateral thoracoscopic fashion.
In this approach, surgeons do about 95% of the operation on the left side to form a maximal thymectomy, “and finish taking out the specimen on the right side, making sure we can see both phrenic nerves in their entirety,” Dr. Sonett, chief of general thoracic surgery at Columbia University Medical Center, New York, said in a video interview at the annual meeting of the Society of Thoracic Surgeons.
Although there is no proof to date that thymectomy improves long-term outcomes for patients with myasthenia gravis, results from a large, international trial sponsored by the National Institutes of Health are expected to inform clinical practice about this topic, said Dr. Sonett, who is also director of the university’s high-risk lung assessment program.
Dr. Sonett reported having no relevant financial conflicts.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
PHOENIX – In the clinical experience of Dr. Joshua R. Sonett, VATS thymectomy for myasthenia gravis is best performed in a bilateral thoracoscopic fashion.
In this approach, surgeons do about 95% of the operation on the left side to form a maximal thymectomy, “and finish taking out the specimen on the right side, making sure we can see both phrenic nerves in their entirety,” Dr. Sonett, chief of general thoracic surgery at Columbia University Medical Center, New York, said in a video interview at the annual meeting of the Society of Thoracic Surgeons.
Although there is no proof to date that thymectomy improves long-term outcomes for patients with myasthenia gravis, results from a large, international trial sponsored by the National Institutes of Health are expected to inform clinical practice about this topic, said Dr. Sonett, who is also director of the university’s high-risk lung assessment program.
Dr. Sonett reported having no relevant financial conflicts.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
PHOENIX – In the clinical experience of Dr. Joshua R. Sonett, VATS thymectomy for myasthenia gravis is best performed in a bilateral thoracoscopic fashion.
In this approach, surgeons do about 95% of the operation on the left side to form a maximal thymectomy, “and finish taking out the specimen on the right side, making sure we can see both phrenic nerves in their entirety,” Dr. Sonett, chief of general thoracic surgery at Columbia University Medical Center, New York, said in a video interview at the annual meeting of the Society of Thoracic Surgeons.
Although there is no proof to date that thymectomy improves long-term outcomes for patients with myasthenia gravis, results from a large, international trial sponsored by the National Institutes of Health are expected to inform clinical practice about this topic, said Dr. Sonett, who is also director of the university’s high-risk lung assessment program.
Dr. Sonett reported having no relevant financial conflicts.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYIS FROM THE STS ANNUAL MEETING
STS: Planning for mass casualties builds on routine trauma care
PHOENIX – Surgeons are the logical choice for taking the lead in formulating a hospital plan for dealing with mass casualties, and when doing so they should use their usual trauma-management practices as the cornerstone, Dr. Kenneth L. Mattox recommended at the annual meeting of the Society of Thoracic Surgeons.
“The disaster plan is built on the trauma plan, and surgeons are at the heart of it,” said Dr. Mattox, chief of staff and surgeon in chief at Ben Taub Hospital in Houston, during a session on disaster preparedness and mass casualties. “When it’s not built on the trauma plan, it can be a nightmare,” he warned.
“Disasters are local. One size [of disaster response] does not fit all. A hurricane in Miami is not like an earthquake in San Francisco or a shooter in Colorado,” which is why each hospital and community needs to devise its own, localized plan. “Surgeons know their community’s organization,” and the vast majority of mass casualty events result in no more patients and are not more daunting than a busy Friday night of injuries at urban trauma centers, Dr. Mattox said. It’s also critical that a hospital leader be in charge at the center and recognize that the hospital’s resources will need to suffice to meet a mass-casualty challenge.
“The ‘cavalry’ will not come over the hill, and even if the cavalry were to arrive, they won’t be credentialed in your state, they won’t know how to deal with your crisis, and they won’t know your local resources. You are the boss.”
Dr. Mattox recommended that interested surgeons get involved with their community’s disaster plan and set up their mass-casualty protocols in advance, but he warned against trying to come up with anything special. “Treat it like you do the Friday night crisis,” he suggested. “Use your routine triage criteria, the way you handle trauma patients all the time, and don’t try to do anything special. If you try to do something special, it always comes back to bite you.”
Although the idea of a disaster and mass casualties may sound daunting, Dr. Mattox noted that history has repeatedly supported the 10% rule: Only 10% of the survivors of a mass-casualty event need hospitalization, and of that 10%, it is only another 10% (1% of the starting population) who need attention in the operating room or ICU. That puts a premium on accurate and effective triage, which initially can be handled by nurses or emergency personnel, and then ultimately by surgeons to identify the small number of patients who truly need immediate surgical attention.
Recent world developments have shown that hospitals handling mass casualties must also think about and guard against a new challenge: the terrorist or shooter who targets the hospital itself. As a consequence, mass-casualty drills at hospitals should include practicing steps to better safeguard the surgical wing at a hospital from attack. This could be as simple as shoving door stops under doors to help keep them securely closed, said Dr. Mattox, who is also a distinguished service professor at Baylor College of Medicine in Houston. He recommended that surgical units rehearse their disaster drills often enough to refine their approaches and make them automatic, but not so often as to numb the staff to an actual event.
Dr. Mattox and his colleagues conduct an annual, 1-day course on medical disaster response.
He had no disclosures aside from serving as program director for an annual course on medical disaster response.
On Twitter @mitchelzoler
PHOENIX – Surgeons are the logical choice for taking the lead in formulating a hospital plan for dealing with mass casualties, and when doing so they should use their usual trauma-management practices as the cornerstone, Dr. Kenneth L. Mattox recommended at the annual meeting of the Society of Thoracic Surgeons.
“The disaster plan is built on the trauma plan, and surgeons are at the heart of it,” said Dr. Mattox, chief of staff and surgeon in chief at Ben Taub Hospital in Houston, during a session on disaster preparedness and mass casualties. “When it’s not built on the trauma plan, it can be a nightmare,” he warned.
“Disasters are local. One size [of disaster response] does not fit all. A hurricane in Miami is not like an earthquake in San Francisco or a shooter in Colorado,” which is why each hospital and community needs to devise its own, localized plan. “Surgeons know their community’s organization,” and the vast majority of mass casualty events result in no more patients and are not more daunting than a busy Friday night of injuries at urban trauma centers, Dr. Mattox said. It’s also critical that a hospital leader be in charge at the center and recognize that the hospital’s resources will need to suffice to meet a mass-casualty challenge.
“The ‘cavalry’ will not come over the hill, and even if the cavalry were to arrive, they won’t be credentialed in your state, they won’t know how to deal with your crisis, and they won’t know your local resources. You are the boss.”
Dr. Mattox recommended that interested surgeons get involved with their community’s disaster plan and set up their mass-casualty protocols in advance, but he warned against trying to come up with anything special. “Treat it like you do the Friday night crisis,” he suggested. “Use your routine triage criteria, the way you handle trauma patients all the time, and don’t try to do anything special. If you try to do something special, it always comes back to bite you.”
Although the idea of a disaster and mass casualties may sound daunting, Dr. Mattox noted that history has repeatedly supported the 10% rule: Only 10% of the survivors of a mass-casualty event need hospitalization, and of that 10%, it is only another 10% (1% of the starting population) who need attention in the operating room or ICU. That puts a premium on accurate and effective triage, which initially can be handled by nurses or emergency personnel, and then ultimately by surgeons to identify the small number of patients who truly need immediate surgical attention.
Recent world developments have shown that hospitals handling mass casualties must also think about and guard against a new challenge: the terrorist or shooter who targets the hospital itself. As a consequence, mass-casualty drills at hospitals should include practicing steps to better safeguard the surgical wing at a hospital from attack. This could be as simple as shoving door stops under doors to help keep them securely closed, said Dr. Mattox, who is also a distinguished service professor at Baylor College of Medicine in Houston. He recommended that surgical units rehearse their disaster drills often enough to refine their approaches and make them automatic, but not so often as to numb the staff to an actual event.
Dr. Mattox and his colleagues conduct an annual, 1-day course on medical disaster response.
He had no disclosures aside from serving as program director for an annual course on medical disaster response.
On Twitter @mitchelzoler
PHOENIX – Surgeons are the logical choice for taking the lead in formulating a hospital plan for dealing with mass casualties, and when doing so they should use their usual trauma-management practices as the cornerstone, Dr. Kenneth L. Mattox recommended at the annual meeting of the Society of Thoracic Surgeons.
“The disaster plan is built on the trauma plan, and surgeons are at the heart of it,” said Dr. Mattox, chief of staff and surgeon in chief at Ben Taub Hospital in Houston, during a session on disaster preparedness and mass casualties. “When it’s not built on the trauma plan, it can be a nightmare,” he warned.
“Disasters are local. One size [of disaster response] does not fit all. A hurricane in Miami is not like an earthquake in San Francisco or a shooter in Colorado,” which is why each hospital and community needs to devise its own, localized plan. “Surgeons know their community’s organization,” and the vast majority of mass casualty events result in no more patients and are not more daunting than a busy Friday night of injuries at urban trauma centers, Dr. Mattox said. It’s also critical that a hospital leader be in charge at the center and recognize that the hospital’s resources will need to suffice to meet a mass-casualty challenge.
“The ‘cavalry’ will not come over the hill, and even if the cavalry were to arrive, they won’t be credentialed in your state, they won’t know how to deal with your crisis, and they won’t know your local resources. You are the boss.”
Dr. Mattox recommended that interested surgeons get involved with their community’s disaster plan and set up their mass-casualty protocols in advance, but he warned against trying to come up with anything special. “Treat it like you do the Friday night crisis,” he suggested. “Use your routine triage criteria, the way you handle trauma patients all the time, and don’t try to do anything special. If you try to do something special, it always comes back to bite you.”
Although the idea of a disaster and mass casualties may sound daunting, Dr. Mattox noted that history has repeatedly supported the 10% rule: Only 10% of the survivors of a mass-casualty event need hospitalization, and of that 10%, it is only another 10% (1% of the starting population) who need attention in the operating room or ICU. That puts a premium on accurate and effective triage, which initially can be handled by nurses or emergency personnel, and then ultimately by surgeons to identify the small number of patients who truly need immediate surgical attention.
Recent world developments have shown that hospitals handling mass casualties must also think about and guard against a new challenge: the terrorist or shooter who targets the hospital itself. As a consequence, mass-casualty drills at hospitals should include practicing steps to better safeguard the surgical wing at a hospital from attack. This could be as simple as shoving door stops under doors to help keep them securely closed, said Dr. Mattox, who is also a distinguished service professor at Baylor College of Medicine in Houston. He recommended that surgical units rehearse their disaster drills often enough to refine their approaches and make them automatic, but not so often as to numb the staff to an actual event.
Dr. Mattox and his colleagues conduct an annual, 1-day course on medical disaster response.
He had no disclosures aside from serving as program director for an annual course on medical disaster response.
On Twitter @mitchelzoler
AT THE STS ANNUAL MEETING
AAP says newborn pain management plans essential for all providers
Repeated exposure to physical pain can have both short-term and long-term adverse effects in newborns, yet providers too inconsistently assess and adequately manage pain in neonates, the American Academy of Pediatrics said in an updated policy statement on preventing and managing procedural pain in these infants.
“Neonates are frequently subjected to painful procedures, with the most immature infants receiving the highest number of painful events,” wrote the AAP Committee on Fetus and Newborn and the AAP Section on Anesthesiology and Pain Medicine. Premature infants also are at the highest risk for long-term sequelae, the committees noted. “These sequelae include physiologic instability; altered brain development; and abnormal neurodevelopment, somatosensory, and stress response systems, which can persist into childhood” (Pediatrics. 2016 Jan 25. doi: 10.1542/peds.2015-4271).
The statement nicely summarizes current evidence on the evaluation and management of pain in neonates, as well as potential short-term and long-term negative effects, said Dr. Clay T. Jones, a neonatal hospitalist at Newton-Wellesley Hospital in Newton, Mass., who was not involved in drafting the statement.
“It is a nice testament to how far we’ve come since the days of performing major surgeries in newborns without the use of analgesic medications, but there is still considerable room for improvement,” Dr. Jones said in an interview. “Although we’ve learned a lot about pain in this population over the past few decades, the authors go to great lengths to make it clear that the optimal way to treat pain hasn’t been established yet, and that the evaluation of risk versus benefit in regards to management using pharmaceutical agents is ongoing.”
The statement described the challenges of effective pain management, including foremost the newborn’s inability to communicate and the dearth of information about effective pain assessments and management in this population.
“Contextual factors such as gestational age and behavioral state may play a significant role in pain assessment and are beginning to be included in some assessment tools,” the committees wrote. “New and emerging technologies to measure pain responses, such as near-infrared spectroscopy, amplitude-integrated electroencephalography, functional MRI, skin conductance, and heart rate variability assessment, are being investigated.”
In the meantime, however, all facilities caring for newborns should implement a pain prevention program that takes advantage of what pain management strategies do exist. In addition to reviewing these strategies, the statement recommended all providers implement and use pain assessment and management plans that include both pharmacologic and nonpharmacologic therapies for major procedures and routine minor interventions that might still cause pain.
“Where this report might have the largest impact is in the outpatient offices of pediatric medical providers and in newborn nurseries,” Dr. Jones said. “It is not uncommon for young infants to undergo painful medical procedures, such as heel sticks and circumcisions, without a systematic approach to pain evaluation and inconsistent efforts to prevent or reduce pain.”
Yet there is no excuse for this lack of a consistent approach, he said.
“Nonpharmaceutical interventions are safe, easy to implement, [and] inexpensive, and there is good evidence that they reduce physiologic surrogate markers for pain such as blood pressure, heart rate, and respiratory rate,” Dr. Jones said.
The statement’s first recommendation is that all institutions have written guidelines for a stepwise plan of pain prevention and treatment in newborns. This plan also should include use of currently available and validated neonatal assessment tools “before, during, and after painful procedures to monitor the effectiveness of pain relief interventions.”
Another recommendation urged pediatricians and other neonatal health care providers and family members to receive ongoing education about recognizing and assessing pain in newborns and then managing it as much as current knowledge and evidence allow. The committees called for more research into pain assessment tools and pain prevention and amelioration strategies, including pharmacologic options.
The nonpharmacologic strategies shown to be effective for reducing pain during short-term mild or moderately painful procedures include facilitated tucking, sensorial stimulation, nonnutritive sucking, and breastfeeding or providing expressed human milk.
“Anything we can do to ease pain will improve a baby’s quality of life,” said Dr. Nathan Boonstra of Blank Children’s Hospital pediatric clinic in Des Moines, Iowa, who was not involved in writing the statement.
“Pediatricians should always be judicious when deciding to draw blood, but when we need to, we should reflexively think about what can keep the procedure’s pain at a minimum,” he said in an interview. “Many of my patients’ mothers instinctively want to breastfeed to help their newborns through something painful, and their instinct serves them well.”
The policy statement mentioned oral sucrose and/or glucose solutions as effective analgesic options for mild to moderately painful procedures, but recommended these be prescribed and tracked as medication.
This strategy carries risks and other drawbacks, however, Dr. Thomas M Seman, a pediatrician in group practice in Danvers, Mass., said in an interview
“Having sucrose or glucose solutions in the office can be dangerous because of the risk of overuse and hyperglycemia as well as the cost of these items,” said Dr. Seman, who was not involved with drafting the AAP statement. His office policy primarily focuses on the parents holding their children and talking, singing, or humming to them during procedures, followed by feeding and/or acetaminophen, he said.
“The other medications used are prohibitive for a number of reasons,” said Dr. Seman, although he added that most of the procedures described in the statement are performed on premature infants in a NICU with only a few done in private practices.
For example, opioids such as fentanyl and morphine are most frequently used for persistent pain, yet the data on appropriate dosing and long-term effects in the newborn period are “woefully lacking and/or conflicting,” the statement noted. The evidence for benzodiazepines, often used for sedation in the neonatal intensive care, shows little additional analgesic benefit, but these agents can potentiate the risk of respiratory depression and hypotension associated with opioid use. Caution should particularly be exercised before using methadone, ketamine, propofol, and dexmedetomidine because so little is known about safe and effective dosing of these medications in neonates. They also carry various potential risks ranging from neurotoxicity to bradycardia, desaturations, and prolonged hypotension.
While NSAIDs are not recommended at this young age, oral or intravenous acetaminophen has sufficient preliminary safety and efficacy to be considered for postoperative pain relief, according to the statement.
The AAP did not report disclosures for committee members. Dr. Boonstra, Dr. Jones, and Dr. Seman had no relevant financial disclosures.
Repeated exposure to physical pain can have both short-term and long-term adverse effects in newborns, yet providers too inconsistently assess and adequately manage pain in neonates, the American Academy of Pediatrics said in an updated policy statement on preventing and managing procedural pain in these infants.
“Neonates are frequently subjected to painful procedures, with the most immature infants receiving the highest number of painful events,” wrote the AAP Committee on Fetus and Newborn and the AAP Section on Anesthesiology and Pain Medicine. Premature infants also are at the highest risk for long-term sequelae, the committees noted. “These sequelae include physiologic instability; altered brain development; and abnormal neurodevelopment, somatosensory, and stress response systems, which can persist into childhood” (Pediatrics. 2016 Jan 25. doi: 10.1542/peds.2015-4271).
The statement nicely summarizes current evidence on the evaluation and management of pain in neonates, as well as potential short-term and long-term negative effects, said Dr. Clay T. Jones, a neonatal hospitalist at Newton-Wellesley Hospital in Newton, Mass., who was not involved in drafting the statement.
“It is a nice testament to how far we’ve come since the days of performing major surgeries in newborns without the use of analgesic medications, but there is still considerable room for improvement,” Dr. Jones said in an interview. “Although we’ve learned a lot about pain in this population over the past few decades, the authors go to great lengths to make it clear that the optimal way to treat pain hasn’t been established yet, and that the evaluation of risk versus benefit in regards to management using pharmaceutical agents is ongoing.”
The statement described the challenges of effective pain management, including foremost the newborn’s inability to communicate and the dearth of information about effective pain assessments and management in this population.
“Contextual factors such as gestational age and behavioral state may play a significant role in pain assessment and are beginning to be included in some assessment tools,” the committees wrote. “New and emerging technologies to measure pain responses, such as near-infrared spectroscopy, amplitude-integrated electroencephalography, functional MRI, skin conductance, and heart rate variability assessment, are being investigated.”
In the meantime, however, all facilities caring for newborns should implement a pain prevention program that takes advantage of what pain management strategies do exist. In addition to reviewing these strategies, the statement recommended all providers implement and use pain assessment and management plans that include both pharmacologic and nonpharmacologic therapies for major procedures and routine minor interventions that might still cause pain.
“Where this report might have the largest impact is in the outpatient offices of pediatric medical providers and in newborn nurseries,” Dr. Jones said. “It is not uncommon for young infants to undergo painful medical procedures, such as heel sticks and circumcisions, without a systematic approach to pain evaluation and inconsistent efforts to prevent or reduce pain.”
Yet there is no excuse for this lack of a consistent approach, he said.
“Nonpharmaceutical interventions are safe, easy to implement, [and] inexpensive, and there is good evidence that they reduce physiologic surrogate markers for pain such as blood pressure, heart rate, and respiratory rate,” Dr. Jones said.
The statement’s first recommendation is that all institutions have written guidelines for a stepwise plan of pain prevention and treatment in newborns. This plan also should include use of currently available and validated neonatal assessment tools “before, during, and after painful procedures to monitor the effectiveness of pain relief interventions.”
Another recommendation urged pediatricians and other neonatal health care providers and family members to receive ongoing education about recognizing and assessing pain in newborns and then managing it as much as current knowledge and evidence allow. The committees called for more research into pain assessment tools and pain prevention and amelioration strategies, including pharmacologic options.
The nonpharmacologic strategies shown to be effective for reducing pain during short-term mild or moderately painful procedures include facilitated tucking, sensorial stimulation, nonnutritive sucking, and breastfeeding or providing expressed human milk.
“Anything we can do to ease pain will improve a baby’s quality of life,” said Dr. Nathan Boonstra of Blank Children’s Hospital pediatric clinic in Des Moines, Iowa, who was not involved in writing the statement.
“Pediatricians should always be judicious when deciding to draw blood, but when we need to, we should reflexively think about what can keep the procedure’s pain at a minimum,” he said in an interview. “Many of my patients’ mothers instinctively want to breastfeed to help their newborns through something painful, and their instinct serves them well.”
The policy statement mentioned oral sucrose and/or glucose solutions as effective analgesic options for mild to moderately painful procedures, but recommended these be prescribed and tracked as medication.
This strategy carries risks and other drawbacks, however, Dr. Thomas M Seman, a pediatrician in group practice in Danvers, Mass., said in an interview
“Having sucrose or glucose solutions in the office can be dangerous because of the risk of overuse and hyperglycemia as well as the cost of these items,” said Dr. Seman, who was not involved with drafting the AAP statement. His office policy primarily focuses on the parents holding their children and talking, singing, or humming to them during procedures, followed by feeding and/or acetaminophen, he said.
“The other medications used are prohibitive for a number of reasons,” said Dr. Seman, although he added that most of the procedures described in the statement are performed on premature infants in a NICU with only a few done in private practices.
For example, opioids such as fentanyl and morphine are most frequently used for persistent pain, yet the data on appropriate dosing and long-term effects in the newborn period are “woefully lacking and/or conflicting,” the statement noted. The evidence for benzodiazepines, often used for sedation in the neonatal intensive care, shows little additional analgesic benefit, but these agents can potentiate the risk of respiratory depression and hypotension associated with opioid use. Caution should particularly be exercised before using methadone, ketamine, propofol, and dexmedetomidine because so little is known about safe and effective dosing of these medications in neonates. They also carry various potential risks ranging from neurotoxicity to bradycardia, desaturations, and prolonged hypotension.
While NSAIDs are not recommended at this young age, oral or intravenous acetaminophen has sufficient preliminary safety and efficacy to be considered for postoperative pain relief, according to the statement.
The AAP did not report disclosures for committee members. Dr. Boonstra, Dr. Jones, and Dr. Seman had no relevant financial disclosures.
Repeated exposure to physical pain can have both short-term and long-term adverse effects in newborns, yet providers too inconsistently assess and adequately manage pain in neonates, the American Academy of Pediatrics said in an updated policy statement on preventing and managing procedural pain in these infants.
“Neonates are frequently subjected to painful procedures, with the most immature infants receiving the highest number of painful events,” wrote the AAP Committee on Fetus and Newborn and the AAP Section on Anesthesiology and Pain Medicine. Premature infants also are at the highest risk for long-term sequelae, the committees noted. “These sequelae include physiologic instability; altered brain development; and abnormal neurodevelopment, somatosensory, and stress response systems, which can persist into childhood” (Pediatrics. 2016 Jan 25. doi: 10.1542/peds.2015-4271).
The statement nicely summarizes current evidence on the evaluation and management of pain in neonates, as well as potential short-term and long-term negative effects, said Dr. Clay T. Jones, a neonatal hospitalist at Newton-Wellesley Hospital in Newton, Mass., who was not involved in drafting the statement.
“It is a nice testament to how far we’ve come since the days of performing major surgeries in newborns without the use of analgesic medications, but there is still considerable room for improvement,” Dr. Jones said in an interview. “Although we’ve learned a lot about pain in this population over the past few decades, the authors go to great lengths to make it clear that the optimal way to treat pain hasn’t been established yet, and that the evaluation of risk versus benefit in regards to management using pharmaceutical agents is ongoing.”
The statement described the challenges of effective pain management, including foremost the newborn’s inability to communicate and the dearth of information about effective pain assessments and management in this population.
“Contextual factors such as gestational age and behavioral state may play a significant role in pain assessment and are beginning to be included in some assessment tools,” the committees wrote. “New and emerging technologies to measure pain responses, such as near-infrared spectroscopy, amplitude-integrated electroencephalography, functional MRI, skin conductance, and heart rate variability assessment, are being investigated.”
In the meantime, however, all facilities caring for newborns should implement a pain prevention program that takes advantage of what pain management strategies do exist. In addition to reviewing these strategies, the statement recommended all providers implement and use pain assessment and management plans that include both pharmacologic and nonpharmacologic therapies for major procedures and routine minor interventions that might still cause pain.
“Where this report might have the largest impact is in the outpatient offices of pediatric medical providers and in newborn nurseries,” Dr. Jones said. “It is not uncommon for young infants to undergo painful medical procedures, such as heel sticks and circumcisions, without a systematic approach to pain evaluation and inconsistent efforts to prevent or reduce pain.”
Yet there is no excuse for this lack of a consistent approach, he said.
“Nonpharmaceutical interventions are safe, easy to implement, [and] inexpensive, and there is good evidence that they reduce physiologic surrogate markers for pain such as blood pressure, heart rate, and respiratory rate,” Dr. Jones said.
The statement’s first recommendation is that all institutions have written guidelines for a stepwise plan of pain prevention and treatment in newborns. This plan also should include use of currently available and validated neonatal assessment tools “before, during, and after painful procedures to monitor the effectiveness of pain relief interventions.”
Another recommendation urged pediatricians and other neonatal health care providers and family members to receive ongoing education about recognizing and assessing pain in newborns and then managing it as much as current knowledge and evidence allow. The committees called for more research into pain assessment tools and pain prevention and amelioration strategies, including pharmacologic options.
The nonpharmacologic strategies shown to be effective for reducing pain during short-term mild or moderately painful procedures include facilitated tucking, sensorial stimulation, nonnutritive sucking, and breastfeeding or providing expressed human milk.
“Anything we can do to ease pain will improve a baby’s quality of life,” said Dr. Nathan Boonstra of Blank Children’s Hospital pediatric clinic in Des Moines, Iowa, who was not involved in writing the statement.
“Pediatricians should always be judicious when deciding to draw blood, but when we need to, we should reflexively think about what can keep the procedure’s pain at a minimum,” he said in an interview. “Many of my patients’ mothers instinctively want to breastfeed to help their newborns through something painful, and their instinct serves them well.”
The policy statement mentioned oral sucrose and/or glucose solutions as effective analgesic options for mild to moderately painful procedures, but recommended these be prescribed and tracked as medication.
This strategy carries risks and other drawbacks, however, Dr. Thomas M Seman, a pediatrician in group practice in Danvers, Mass., said in an interview
“Having sucrose or glucose solutions in the office can be dangerous because of the risk of overuse and hyperglycemia as well as the cost of these items,” said Dr. Seman, who was not involved with drafting the AAP statement. His office policy primarily focuses on the parents holding their children and talking, singing, or humming to them during procedures, followed by feeding and/or acetaminophen, he said.
“The other medications used are prohibitive for a number of reasons,” said Dr. Seman, although he added that most of the procedures described in the statement are performed on premature infants in a NICU with only a few done in private practices.
For example, opioids such as fentanyl and morphine are most frequently used for persistent pain, yet the data on appropriate dosing and long-term effects in the newborn period are “woefully lacking and/or conflicting,” the statement noted. The evidence for benzodiazepines, often used for sedation in the neonatal intensive care, shows little additional analgesic benefit, but these agents can potentiate the risk of respiratory depression and hypotension associated with opioid use. Caution should particularly be exercised before using methadone, ketamine, propofol, and dexmedetomidine because so little is known about safe and effective dosing of these medications in neonates. They also carry various potential risks ranging from neurotoxicity to bradycardia, desaturations, and prolonged hypotension.
While NSAIDs are not recommended at this young age, oral or intravenous acetaminophen has sufficient preliminary safety and efficacy to be considered for postoperative pain relief, according to the statement.
The AAP did not report disclosures for committee members. Dr. Boonstra, Dr. Jones, and Dr. Seman had no relevant financial disclosures.
FROM PEDIATRICS
STS: BMI impacts risk for complications after lung resection
PHOENIX – Being underweight is associated with a substantially increased risk of complications following lung resection for cancer, results from a large database study found.
“This is not generally known among surgeons or their patients,” Dr. Trevor Williams said in an interview before the annual meeting of the Society of Thoracic Surgeons. “Studies are conflicting about the relationship of BMI [body mass index] to surgical outcomes. Most of the previous studies simply categorize BMI as overweight or not. We’ve stratified based on World Health Organization categories to get a more precise look at BMI.”
Dr. Williams, a surgeon at the University of Chicago Medical Center, and his associates evaluated 41,446 patients in the STS General Thoracic Surgery Database who underwent elective anatomic lung resection for cancer between 2009 and 2014. Their mean age was 68 years, and 53% were female. The researchers performed multivariable analysis after adjusting for validated STS risk model covariates, including gender and spirometry.
According to WHO criteria for BMI, 3% were underweight (less than 18.5 kg/m2); 33.5% were normal weight (18.5-24.9 kg/m2); 35.4% were overweight (25-29.9 kg/m2); 18.1% were obese I (30-34.9 kg/m2); 6.4% were obese II (35-39.9 kg/m2), and 3.6% were obese III (40 kg/m2 or greater). Dr. Williams and his associates observed that women were more often underweight, compared with men (4.1% vs. 1.8%, respectively; P less than .001), and underweight patients more often had chronic obstructive pulmonary disease (51.7% vs. 35.2%; P less than .001). Pulmonary complication rates were higher among underweight and obese III patients (P less than .001), while being underweight was also associated with higher rates of infections and any surgical complications.
Multivariable analysis revealed that pulmonary and any postoperative complications were more common among underweight patients (odds ratio, 1.44 and OR, 1.41, respectively), while any major complication was more common among obese III patients (OR, 1.18). Overweight and obese I-II patients were less likely to have any postoperative and pulmonary complications, compared with patients who had a normal BMI. “The finding of underweight patients being such a high-risk patient population is suggested in the literature but not demonstrated as clearly as in this study,” Dr. Williams said. “A truly surprising finding was that obese patients actually have a lower risk of pulmonary and overall complications than ‘normal’-BMI patients.”
He concluded that according to the current analysis, “careful risk assessment is appropriate when considering operating on underweight patients. Whether there are interventions that could be instituted to improve an individual’s risk profile has not been determined. Any preconceived notions about not operating on obese patients due to elevated risk appear to be unfounded.”
Dr. Williams reported having no financial disclosures.
PHOENIX – Being underweight is associated with a substantially increased risk of complications following lung resection for cancer, results from a large database study found.
“This is not generally known among surgeons or their patients,” Dr. Trevor Williams said in an interview before the annual meeting of the Society of Thoracic Surgeons. “Studies are conflicting about the relationship of BMI [body mass index] to surgical outcomes. Most of the previous studies simply categorize BMI as overweight or not. We’ve stratified based on World Health Organization categories to get a more precise look at BMI.”
Dr. Williams, a surgeon at the University of Chicago Medical Center, and his associates evaluated 41,446 patients in the STS General Thoracic Surgery Database who underwent elective anatomic lung resection for cancer between 2009 and 2014. Their mean age was 68 years, and 53% were female. The researchers performed multivariable analysis after adjusting for validated STS risk model covariates, including gender and spirometry.
According to WHO criteria for BMI, 3% were underweight (less than 18.5 kg/m2); 33.5% were normal weight (18.5-24.9 kg/m2); 35.4% were overweight (25-29.9 kg/m2); 18.1% were obese I (30-34.9 kg/m2); 6.4% were obese II (35-39.9 kg/m2), and 3.6% were obese III (40 kg/m2 or greater). Dr. Williams and his associates observed that women were more often underweight, compared with men (4.1% vs. 1.8%, respectively; P less than .001), and underweight patients more often had chronic obstructive pulmonary disease (51.7% vs. 35.2%; P less than .001). Pulmonary complication rates were higher among underweight and obese III patients (P less than .001), while being underweight was also associated with higher rates of infections and any surgical complications.
Multivariable analysis revealed that pulmonary and any postoperative complications were more common among underweight patients (odds ratio, 1.44 and OR, 1.41, respectively), while any major complication was more common among obese III patients (OR, 1.18). Overweight and obese I-II patients were less likely to have any postoperative and pulmonary complications, compared with patients who had a normal BMI. “The finding of underweight patients being such a high-risk patient population is suggested in the literature but not demonstrated as clearly as in this study,” Dr. Williams said. “A truly surprising finding was that obese patients actually have a lower risk of pulmonary and overall complications than ‘normal’-BMI patients.”
He concluded that according to the current analysis, “careful risk assessment is appropriate when considering operating on underweight patients. Whether there are interventions that could be instituted to improve an individual’s risk profile has not been determined. Any preconceived notions about not operating on obese patients due to elevated risk appear to be unfounded.”
Dr. Williams reported having no financial disclosures.
PHOENIX – Being underweight is associated with a substantially increased risk of complications following lung resection for cancer, results from a large database study found.
“This is not generally known among surgeons or their patients,” Dr. Trevor Williams said in an interview before the annual meeting of the Society of Thoracic Surgeons. “Studies are conflicting about the relationship of BMI [body mass index] to surgical outcomes. Most of the previous studies simply categorize BMI as overweight or not. We’ve stratified based on World Health Organization categories to get a more precise look at BMI.”
Dr. Williams, a surgeon at the University of Chicago Medical Center, and his associates evaluated 41,446 patients in the STS General Thoracic Surgery Database who underwent elective anatomic lung resection for cancer between 2009 and 2014. Their mean age was 68 years, and 53% were female. The researchers performed multivariable analysis after adjusting for validated STS risk model covariates, including gender and spirometry.
According to WHO criteria for BMI, 3% were underweight (less than 18.5 kg/m2); 33.5% were normal weight (18.5-24.9 kg/m2); 35.4% were overweight (25-29.9 kg/m2); 18.1% were obese I (30-34.9 kg/m2); 6.4% were obese II (35-39.9 kg/m2), and 3.6% were obese III (40 kg/m2 or greater). Dr. Williams and his associates observed that women were more often underweight, compared with men (4.1% vs. 1.8%, respectively; P less than .001), and underweight patients more often had chronic obstructive pulmonary disease (51.7% vs. 35.2%; P less than .001). Pulmonary complication rates were higher among underweight and obese III patients (P less than .001), while being underweight was also associated with higher rates of infections and any surgical complications.
Multivariable analysis revealed that pulmonary and any postoperative complications were more common among underweight patients (odds ratio, 1.44 and OR, 1.41, respectively), while any major complication was more common among obese III patients (OR, 1.18). Overweight and obese I-II patients were less likely to have any postoperative and pulmonary complications, compared with patients who had a normal BMI. “The finding of underweight patients being such a high-risk patient population is suggested in the literature but not demonstrated as clearly as in this study,” Dr. Williams said. “A truly surprising finding was that obese patients actually have a lower risk of pulmonary and overall complications than ‘normal’-BMI patients.”
He concluded that according to the current analysis, “careful risk assessment is appropriate when considering operating on underweight patients. Whether there are interventions that could be instituted to improve an individual’s risk profile has not been determined. Any preconceived notions about not operating on obese patients due to elevated risk appear to be unfounded.”
Dr. Williams reported having no financial disclosures.
AT THE STS ANNUAL MEETING
Key clinical point: Careful risk assessment is appropriate when considering performing lung resection on underweight patients.
Major finding: Multivariable analysis revealed that pulmonary and any postoperative complications were more common among underweight patients (OR, 1.44 and OR, 1.41, respectively), while any major complication was more common among obese III patients (OR, 1.18).
Data source: An analysis of 41,446 patients in the STS General Thoracic Surgery Database who underwent elective lung resection for cancer between 2009 and 2014.
Disclosures: Dr. Williams reported having no financial disclosures.
