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Enhanced recovery initiative improved bariatric length of stay
ORLANDO – Adopting a 28-point significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative. 
Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).
The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.
“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.
Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.
ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.
The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.
Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.
The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.
Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.
Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.
Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.
Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.
Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.
The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.
ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.
“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “
Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
ORLANDO – Adopting a 28-point significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative.
Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).
The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.
“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.
Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.
ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.
The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.
Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.
The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.
Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.
Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.
Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.
Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.
Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.
The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.
ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.
“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “
Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
ORLANDO – Adopting a 28-point significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative.
Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).
The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.
“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.
Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.
ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.
The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.
Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.
The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.
Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.
Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.
Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.
Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.
Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.
The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.
ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.
“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “
Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
REPORTING FROM ACSQSC 2018
Key clinical point: An evidence-based enhanced recovery protocol reduced length of stay for bariatric surgery patients.
Major finding: Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers.
Study details: Data on 36 bariatric surgery centers and 4,700 patients who underwent procedures in the first 6 months of the data collection period.
Disclosures: Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.
How to prescribe effectively for opioid use disorder
NEW ORLEANS – Physicians committed to fighting the national opioid epidemic really need to take the 8-hour training course on addiction treatment required to obtain a Drug Enforcement Administration ‘X’ number, because it will enable them to prescribe buprenorphine, a drug with unique advantages for many affected patients, Ellie Grossman, MD, asserted at the annual meeting of the American College of Physicians.
Buprenorphine (Subutex) is one of the three medications approved for treatment of opioid use disorder (OUD), along with methadone and naltrexone (Revia). And for certain patients, it’s clearly the best choice, according to Dr. Grossman, a general internist at Harvard Medical School, Boston, and the primary care lead for behavioral health integration at the Cambridge (Mass.) Health Alliance.
The DEA X number certification process, which entails obtaining a waiver through SAMHSA – the Substance Abuse and Mental Health Services Administration – is bureaucratic. It’s unpopular with many physicians. But it’s well worth 8 hours of an internist’s time to get the waiver and gain the ability to prescribe buprenorphine.
“The requirement is admittedly clunky, and many people have strong feelings about whether this is a regulation that should exist,” according to Dr. Grossman. “I myself didn’t need to have special training to prescribe methadone, a full opioid agonist that my patients could easily die from. But I did have to undergo an 8-hour training to prescribe buprenorphine, and it’s much harder to die from that drug.”
She addressed which of the three medications for OUD is the best fit in a given patient, the appropriate treatment duration, and the role of adjunctive counseling, which – spoiler alert – has been cast into question by the results of a major government-funded randomized trial.
Dr. Grossman’s overriding message: “You are saving lives by getting people on medication.”
Indeed, studies have shown that patients with OUD who receive no treatment have a sixfold increase in the standardized mortality ratio, compared with the general population. Contrast that with the less than 2-fold increased risk with medication-assisted treatment and roughly a 2.5-fold increased risk when medication is given short term to cover withdrawal and then tapered and discontinued.
Other documented benefits of long-term medication-assisted treatment of patients with OUD as described in a 2014 Cochrane review include reductions in injection drug use, crime days, HIV-related risk behaviors and seroconversion, and improved health and social functioning.
Of note, those well-documented benefits apply only to methadone, a full opioid agonist, and buprenorphine, a partial agonist, because those two drugs have been around long enough to generate long-term outcome data. Naltrexone, which has a completely different mechanism of action – it’s a full opioid antagonist – has not as of yet.
Individualizing medical therapy for OUD
Physicians can’t write a prescription for methadone. The drug must be administered at a certified opioid treatment program, or OTP, otherwise known as a methadone clinic. Those clinics are highly regulated at both the federal and state levels, with lots of minutia involved. Patient counseling and drug screening are required.
In contrast, a physician with a DEA X number can write a prescription for buprenorphine and have a patient fill it at a pharmacy. There is inherently less structure surrounding buprenorphine therapy than that of methadone, Dr. Grossman noted. There are no hard and fast rules about how often a physician has to see the patient or do drug screens or counseling. Buprenorphine is available as once-daily oral sublingual therapy and, more recently, in long-acting injectable and implantable formulations, although Dr. Grossman believes the jury is still out about how these nonoral agents are best utilized.
“I’m often asked, ‘Which is better, methadone or buprenorphine?’ Really, the answer is they’re both pretty darn good,” according to Dr. Grossman.
The Cochrane review concluded that, in the studies that have used real-world dosing – that is, higher doses than in the initial studies – high-dose buprenorphine and high-dose methadone have similar rates of retention in treatment.
“What I tell patients is that a lot hinges on the structure of the treatment delivery system,” Dr. Grossman said. “If it’s methadone, they’re going to the OTP every day. Some people need more structure; they need a set of eyes on them every day. Or if they are at high risk for medication diversion – for example, someone else in their household might want to steal their medications – going to a methadone program gets around that. Also, when somebody has been on methadone in the past and did well on it and wants to go on it again, I’m likely to say, ‘That sounds like a good fit.’”
Buprenorphine is a good option for patients who don’t require close, structured supervision. It has fewer drug interactions than does methadone and is less prone to cause QTc prolongation. Also, it’s a more realistic option for patients who live so far from an OTP that daily attendance is impractical. And ob.gyns increasingly favor buprenorphine, because the problem of neonatal abstinence syndrome is less severe than when mothers are on methadone.
As for extended-release naltrexone (Vivitrol), the pivotal double-blind Russian trial that won FDA approval for treatment of OUD showed a dramatic improvement in opioid-free weeks (Lancet. 2011 Apr 30;377[9776]:1506-13).
More recently, the 24-week, multicenter, open-label X:BOT trial randomized 570 U.S. patients with OUD to once-monthly extended-release naltrexone or daily sublingual buprenorphine-naloxone (Suboxone). The dropout rate was higher in the extended-release naltrexone arm because patients had to be opioid free for 2 weeks before starting on the opioid antagonist. As a practical matter, that can be difficult to achieve unless a patient has just been released from jail or prison. But the per-protocol relapse rates were similar (Lancet. 2018 Jan 27;391[10118]:309-18).
“Many people interpret this study as saying, with the right patient who can get into an opioid-free state or, if you inherit an opioid-free state, the choice between extended-release naltrexone and buprenorphine-naloxone may be a bit of a wash in terms of clinical effectiveness, as best we can detect,” Dr. Grossman explained. “That said, they’re very different experiences: One is a shot in your butt once a month, the other is something you put in your mouth once a day. Patients typically have a strong point of view regarding what they’re up for.”
Extended-release naltrexone doesn’t require a DEA waiver or attendance at an OTP. But it costs roughly $800 per injection, although many insurers do cover it after additional paperwork is completed. While Dr. Grossman does use extended-release naltrexone in her own practice, it comes with some baggage. The drug comes in a powder, which is mixed with a diluent in the office, creating a thick, frothy substance that’s slow to inject. It has to be kept refrigerated, then warmed up in time for the patient visit.
“If you live somewhere where there’s no OTP and you don’t have a DEA X number, and you have a patient with OUD who’s interested in extended-release naltrexone, it’s not crazy to think about,” she noted.
Duration of medical therapy
Study after study demonstrates that, when treatment stops, the risk of relapse goes up.
“We as health care providers are used to the mentality of chronic diseases, like diabetes, where you’re probably on medicine for the rest of your life,” Dr. Grossman said. “OUD is another chronic disease where you might have a patient on medication for the rest of their life, although you may not want to drum that into their head right up front. It’s kind of scary. I don’t usually talk that way with my diabetic patients when I give them their diagnosis. So, I don’t push it.
“But the reality is, to give them the best chance of health, they should be on medication for a good long time,” she added. “And that’s true for all of the OUD medications.”
The role of counseling
The best evidence of the utility of adjunctive counseling in the treatment of OUD comes from the landmark Prescription Opioid Addiction Treatment Study (POATS), a 653-patient multicenter trial conducted by the National Drug Abuse Treatment Network and funded by the National Institute on Drug Abuse. Participants were randomized to standard medical management including medication and a meeting with a physician every 1-2 weeks, or to standard therapy plus individual counseling with a trained substance use counselor.
To the surprise of many, given that SAMHSA guidance strongly recommends counseling and other forms of behavioral therapy, there was no difference in outcomes between the two groups (Drug Alcohol Depend. 2015 May 1;150:112-9).
Subsequent parsing of the POATS data showed that the subgroup of people who were using heroin rather than prescription pills and who actually attended at least 60% of their counseling sessions did better than if they were randomized to no counseling.
“There’s still room for quibbling about the study, but many people would say, ‘You know, it’s not a slam dunk that everybody needs counseling,’ ” the internist commented.
“So, how do we pick the right treatment for our patients with OUD? It’s what feels right for them,” Dr. Grossman cautioned. “This gets back to what we do every day in managing chronic diseases: We nudge, we encourage, we use our motivational interviewing skills to help people figure out how they can change their lives and get healthier. There’s a long list of things going on in our patients’ lives that are going to help guide that decision.
“The message here: Medication is better than no medication, but it’s not a slam dunk which medication or how,” she concluded.
NEW ORLEANS – Physicians committed to fighting the national opioid epidemic really need to take the 8-hour training course on addiction treatment required to obtain a Drug Enforcement Administration ‘X’ number, because it will enable them to prescribe buprenorphine, a drug with unique advantages for many affected patients, Ellie Grossman, MD, asserted at the annual meeting of the American College of Physicians.
Buprenorphine (Subutex) is one of the three medications approved for treatment of opioid use disorder (OUD), along with methadone and naltrexone (Revia). And for certain patients, it’s clearly the best choice, according to Dr. Grossman, a general internist at Harvard Medical School, Boston, and the primary care lead for behavioral health integration at the Cambridge (Mass.) Health Alliance.
The DEA X number certification process, which entails obtaining a waiver through SAMHSA – the Substance Abuse and Mental Health Services Administration – is bureaucratic. It’s unpopular with many physicians. But it’s well worth 8 hours of an internist’s time to get the waiver and gain the ability to prescribe buprenorphine.
“The requirement is admittedly clunky, and many people have strong feelings about whether this is a regulation that should exist,” according to Dr. Grossman. “I myself didn’t need to have special training to prescribe methadone, a full opioid agonist that my patients could easily die from. But I did have to undergo an 8-hour training to prescribe buprenorphine, and it’s much harder to die from that drug.”
She addressed which of the three medications for OUD is the best fit in a given patient, the appropriate treatment duration, and the role of adjunctive counseling, which – spoiler alert – has been cast into question by the results of a major government-funded randomized trial.
Dr. Grossman’s overriding message: “You are saving lives by getting people on medication.”
Indeed, studies have shown that patients with OUD who receive no treatment have a sixfold increase in the standardized mortality ratio, compared with the general population. Contrast that with the less than 2-fold increased risk with medication-assisted treatment and roughly a 2.5-fold increased risk when medication is given short term to cover withdrawal and then tapered and discontinued.
Other documented benefits of long-term medication-assisted treatment of patients with OUD as described in a 2014 Cochrane review include reductions in injection drug use, crime days, HIV-related risk behaviors and seroconversion, and improved health and social functioning.
Of note, those well-documented benefits apply only to methadone, a full opioid agonist, and buprenorphine, a partial agonist, because those two drugs have been around long enough to generate long-term outcome data. Naltrexone, which has a completely different mechanism of action – it’s a full opioid antagonist – has not as of yet.
Individualizing medical therapy for OUD
Physicians can’t write a prescription for methadone. The drug must be administered at a certified opioid treatment program, or OTP, otherwise known as a methadone clinic. Those clinics are highly regulated at both the federal and state levels, with lots of minutia involved. Patient counseling and drug screening are required.
In contrast, a physician with a DEA X number can write a prescription for buprenorphine and have a patient fill it at a pharmacy. There is inherently less structure surrounding buprenorphine therapy than that of methadone, Dr. Grossman noted. There are no hard and fast rules about how often a physician has to see the patient or do drug screens or counseling. Buprenorphine is available as once-daily oral sublingual therapy and, more recently, in long-acting injectable and implantable formulations, although Dr. Grossman believes the jury is still out about how these nonoral agents are best utilized.
“I’m often asked, ‘Which is better, methadone or buprenorphine?’ Really, the answer is they’re both pretty darn good,” according to Dr. Grossman.
The Cochrane review concluded that, in the studies that have used real-world dosing – that is, higher doses than in the initial studies – high-dose buprenorphine and high-dose methadone have similar rates of retention in treatment.
“What I tell patients is that a lot hinges on the structure of the treatment delivery system,” Dr. Grossman said. “If it’s methadone, they’re going to the OTP every day. Some people need more structure; they need a set of eyes on them every day. Or if they are at high risk for medication diversion – for example, someone else in their household might want to steal their medications – going to a methadone program gets around that. Also, when somebody has been on methadone in the past and did well on it and wants to go on it again, I’m likely to say, ‘That sounds like a good fit.’”
Buprenorphine is a good option for patients who don’t require close, structured supervision. It has fewer drug interactions than does methadone and is less prone to cause QTc prolongation. Also, it’s a more realistic option for patients who live so far from an OTP that daily attendance is impractical. And ob.gyns increasingly favor buprenorphine, because the problem of neonatal abstinence syndrome is less severe than when mothers are on methadone.
As for extended-release naltrexone (Vivitrol), the pivotal double-blind Russian trial that won FDA approval for treatment of OUD showed a dramatic improvement in opioid-free weeks (Lancet. 2011 Apr 30;377[9776]:1506-13).
More recently, the 24-week, multicenter, open-label X:BOT trial randomized 570 U.S. patients with OUD to once-monthly extended-release naltrexone or daily sublingual buprenorphine-naloxone (Suboxone). The dropout rate was higher in the extended-release naltrexone arm because patients had to be opioid free for 2 weeks before starting on the opioid antagonist. As a practical matter, that can be difficult to achieve unless a patient has just been released from jail or prison. But the per-protocol relapse rates were similar (Lancet. 2018 Jan 27;391[10118]:309-18).
“Many people interpret this study as saying, with the right patient who can get into an opioid-free state or, if you inherit an opioid-free state, the choice between extended-release naltrexone and buprenorphine-naloxone may be a bit of a wash in terms of clinical effectiveness, as best we can detect,” Dr. Grossman explained. “That said, they’re very different experiences: One is a shot in your butt once a month, the other is something you put in your mouth once a day. Patients typically have a strong point of view regarding what they’re up for.”
Extended-release naltrexone doesn’t require a DEA waiver or attendance at an OTP. But it costs roughly $800 per injection, although many insurers do cover it after additional paperwork is completed. While Dr. Grossman does use extended-release naltrexone in her own practice, it comes with some baggage. The drug comes in a powder, which is mixed with a diluent in the office, creating a thick, frothy substance that’s slow to inject. It has to be kept refrigerated, then warmed up in time for the patient visit.
“If you live somewhere where there’s no OTP and you don’t have a DEA X number, and you have a patient with OUD who’s interested in extended-release naltrexone, it’s not crazy to think about,” she noted.
Duration of medical therapy
Study after study demonstrates that, when treatment stops, the risk of relapse goes up.
“We as health care providers are used to the mentality of chronic diseases, like diabetes, where you’re probably on medicine for the rest of your life,” Dr. Grossman said. “OUD is another chronic disease where you might have a patient on medication for the rest of their life, although you may not want to drum that into their head right up front. It’s kind of scary. I don’t usually talk that way with my diabetic patients when I give them their diagnosis. So, I don’t push it.
“But the reality is, to give them the best chance of health, they should be on medication for a good long time,” she added. “And that’s true for all of the OUD medications.”
The role of counseling
The best evidence of the utility of adjunctive counseling in the treatment of OUD comes from the landmark Prescription Opioid Addiction Treatment Study (POATS), a 653-patient multicenter trial conducted by the National Drug Abuse Treatment Network and funded by the National Institute on Drug Abuse. Participants were randomized to standard medical management including medication and a meeting with a physician every 1-2 weeks, or to standard therapy plus individual counseling with a trained substance use counselor.
To the surprise of many, given that SAMHSA guidance strongly recommends counseling and other forms of behavioral therapy, there was no difference in outcomes between the two groups (Drug Alcohol Depend. 2015 May 1;150:112-9).
Subsequent parsing of the POATS data showed that the subgroup of people who were using heroin rather than prescription pills and who actually attended at least 60% of their counseling sessions did better than if they were randomized to no counseling.
“There’s still room for quibbling about the study, but many people would say, ‘You know, it’s not a slam dunk that everybody needs counseling,’ ” the internist commented.
“So, how do we pick the right treatment for our patients with OUD? It’s what feels right for them,” Dr. Grossman cautioned. “This gets back to what we do every day in managing chronic diseases: We nudge, we encourage, we use our motivational interviewing skills to help people figure out how they can change their lives and get healthier. There’s a long list of things going on in our patients’ lives that are going to help guide that decision.
“The message here: Medication is better than no medication, but it’s not a slam dunk which medication or how,” she concluded.
NEW ORLEANS – Physicians committed to fighting the national opioid epidemic really need to take the 8-hour training course on addiction treatment required to obtain a Drug Enforcement Administration ‘X’ number, because it will enable them to prescribe buprenorphine, a drug with unique advantages for many affected patients, Ellie Grossman, MD, asserted at the annual meeting of the American College of Physicians.
Buprenorphine (Subutex) is one of the three medications approved for treatment of opioid use disorder (OUD), along with methadone and naltrexone (Revia). And for certain patients, it’s clearly the best choice, according to Dr. Grossman, a general internist at Harvard Medical School, Boston, and the primary care lead for behavioral health integration at the Cambridge (Mass.) Health Alliance.
The DEA X number certification process, which entails obtaining a waiver through SAMHSA – the Substance Abuse and Mental Health Services Administration – is bureaucratic. It’s unpopular with many physicians. But it’s well worth 8 hours of an internist’s time to get the waiver and gain the ability to prescribe buprenorphine.
“The requirement is admittedly clunky, and many people have strong feelings about whether this is a regulation that should exist,” according to Dr. Grossman. “I myself didn’t need to have special training to prescribe methadone, a full opioid agonist that my patients could easily die from. But I did have to undergo an 8-hour training to prescribe buprenorphine, and it’s much harder to die from that drug.”
She addressed which of the three medications for OUD is the best fit in a given patient, the appropriate treatment duration, and the role of adjunctive counseling, which – spoiler alert – has been cast into question by the results of a major government-funded randomized trial.
Dr. Grossman’s overriding message: “You are saving lives by getting people on medication.”
Indeed, studies have shown that patients with OUD who receive no treatment have a sixfold increase in the standardized mortality ratio, compared with the general population. Contrast that with the less than 2-fold increased risk with medication-assisted treatment and roughly a 2.5-fold increased risk when medication is given short term to cover withdrawal and then tapered and discontinued.
Other documented benefits of long-term medication-assisted treatment of patients with OUD as described in a 2014 Cochrane review include reductions in injection drug use, crime days, HIV-related risk behaviors and seroconversion, and improved health and social functioning.
Of note, those well-documented benefits apply only to methadone, a full opioid agonist, and buprenorphine, a partial agonist, because those two drugs have been around long enough to generate long-term outcome data. Naltrexone, which has a completely different mechanism of action – it’s a full opioid antagonist – has not as of yet.
Individualizing medical therapy for OUD
Physicians can’t write a prescription for methadone. The drug must be administered at a certified opioid treatment program, or OTP, otherwise known as a methadone clinic. Those clinics are highly regulated at both the federal and state levels, with lots of minutia involved. Patient counseling and drug screening are required.
In contrast, a physician with a DEA X number can write a prescription for buprenorphine and have a patient fill it at a pharmacy. There is inherently less structure surrounding buprenorphine therapy than that of methadone, Dr. Grossman noted. There are no hard and fast rules about how often a physician has to see the patient or do drug screens or counseling. Buprenorphine is available as once-daily oral sublingual therapy and, more recently, in long-acting injectable and implantable formulations, although Dr. Grossman believes the jury is still out about how these nonoral agents are best utilized.
“I’m often asked, ‘Which is better, methadone or buprenorphine?’ Really, the answer is they’re both pretty darn good,” according to Dr. Grossman.
The Cochrane review concluded that, in the studies that have used real-world dosing – that is, higher doses than in the initial studies – high-dose buprenorphine and high-dose methadone have similar rates of retention in treatment.
“What I tell patients is that a lot hinges on the structure of the treatment delivery system,” Dr. Grossman said. “If it’s methadone, they’re going to the OTP every day. Some people need more structure; they need a set of eyes on them every day. Or if they are at high risk for medication diversion – for example, someone else in their household might want to steal their medications – going to a methadone program gets around that. Also, when somebody has been on methadone in the past and did well on it and wants to go on it again, I’m likely to say, ‘That sounds like a good fit.’”
Buprenorphine is a good option for patients who don’t require close, structured supervision. It has fewer drug interactions than does methadone and is less prone to cause QTc prolongation. Also, it’s a more realistic option for patients who live so far from an OTP that daily attendance is impractical. And ob.gyns increasingly favor buprenorphine, because the problem of neonatal abstinence syndrome is less severe than when mothers are on methadone.
As for extended-release naltrexone (Vivitrol), the pivotal double-blind Russian trial that won FDA approval for treatment of OUD showed a dramatic improvement in opioid-free weeks (Lancet. 2011 Apr 30;377[9776]:1506-13).
More recently, the 24-week, multicenter, open-label X:BOT trial randomized 570 U.S. patients with OUD to once-monthly extended-release naltrexone or daily sublingual buprenorphine-naloxone (Suboxone). The dropout rate was higher in the extended-release naltrexone arm because patients had to be opioid free for 2 weeks before starting on the opioid antagonist. As a practical matter, that can be difficult to achieve unless a patient has just been released from jail or prison. But the per-protocol relapse rates were similar (Lancet. 2018 Jan 27;391[10118]:309-18).
“Many people interpret this study as saying, with the right patient who can get into an opioid-free state or, if you inherit an opioid-free state, the choice between extended-release naltrexone and buprenorphine-naloxone may be a bit of a wash in terms of clinical effectiveness, as best we can detect,” Dr. Grossman explained. “That said, they’re very different experiences: One is a shot in your butt once a month, the other is something you put in your mouth once a day. Patients typically have a strong point of view regarding what they’re up for.”
Extended-release naltrexone doesn’t require a DEA waiver or attendance at an OTP. But it costs roughly $800 per injection, although many insurers do cover it after additional paperwork is completed. While Dr. Grossman does use extended-release naltrexone in her own practice, it comes with some baggage. The drug comes in a powder, which is mixed with a diluent in the office, creating a thick, frothy substance that’s slow to inject. It has to be kept refrigerated, then warmed up in time for the patient visit.
“If you live somewhere where there’s no OTP and you don’t have a DEA X number, and you have a patient with OUD who’s interested in extended-release naltrexone, it’s not crazy to think about,” she noted.
Duration of medical therapy
Study after study demonstrates that, when treatment stops, the risk of relapse goes up.
“We as health care providers are used to the mentality of chronic diseases, like diabetes, where you’re probably on medicine for the rest of your life,” Dr. Grossman said. “OUD is another chronic disease where you might have a patient on medication for the rest of their life, although you may not want to drum that into their head right up front. It’s kind of scary. I don’t usually talk that way with my diabetic patients when I give them their diagnosis. So, I don’t push it.
“But the reality is, to give them the best chance of health, they should be on medication for a good long time,” she added. “And that’s true for all of the OUD medications.”
The role of counseling
The best evidence of the utility of adjunctive counseling in the treatment of OUD comes from the landmark Prescription Opioid Addiction Treatment Study (POATS), a 653-patient multicenter trial conducted by the National Drug Abuse Treatment Network and funded by the National Institute on Drug Abuse. Participants were randomized to standard medical management including medication and a meeting with a physician every 1-2 weeks, or to standard therapy plus individual counseling with a trained substance use counselor.
To the surprise of many, given that SAMHSA guidance strongly recommends counseling and other forms of behavioral therapy, there was no difference in outcomes between the two groups (Drug Alcohol Depend. 2015 May 1;150:112-9).
Subsequent parsing of the POATS data showed that the subgroup of people who were using heroin rather than prescription pills and who actually attended at least 60% of their counseling sessions did better than if they were randomized to no counseling.
“There’s still room for quibbling about the study, but many people would say, ‘You know, it’s not a slam dunk that everybody needs counseling,’ ” the internist commented.
“So, how do we pick the right treatment for our patients with OUD? It’s what feels right for them,” Dr. Grossman cautioned. “This gets back to what we do every day in managing chronic diseases: We nudge, we encourage, we use our motivational interviewing skills to help people figure out how they can change their lives and get healthier. There’s a long list of things going on in our patients’ lives that are going to help guide that decision.
“The message here: Medication is better than no medication, but it’s not a slam dunk which medication or how,” she concluded.
REPORTING FROM ACP INTERNAL MEDICINE
Mandated 1-hour sepsis care protocol lowers mortality in children
A bundle of blood cultures, broad-spectrum antibiotics, and intravenous fluid replacement reduces risk of in-hospital mortality among children with sepsis if all three forms of management are initiated within an hour, according to a cohort study published in JAMA.
Although published guidelines already recommend prompt initiation of these three elements of care, a mandate created in New York in 2013 called for these interventions to be initiated in children within 1 hour of sepsis recognition. The newly published cohort study shows a mortality benefit when this is done.
In the study, which evaluated the impact of the bundle as well as each of the components in 1,179 pediatric patients with sepsis treated at 54 hospitals, the risk-adjusted odds ratio of in-hospital mortality was 0.59 (P = .02) among patients receiving the mandated protocol, compared with those who did not.
When provided within 1 hour, none of the individual components of the bundles were associated with a significant reduction of risk-adjusted, in-hospital mortality by themselves. However, there were trends for benefit with blood cultures (OR, 0.73; P = .1) and broad-spectrum antibiotics (OR, 0.78; P = .18). There was no trend for administration of intravenous fluids (OR, 0.88; P = .56), for which the mandate specified 20 mL/kg.
Although 46.5% of patients received intravenous fluids, 62.8% received broad-spectrum antibiotics, and blood cultures were obtained in 67.7% of the children within 1 hour, only 24.9% were managed with the entire sepsis bundle. Across hospitals, the proportion of children completing the bundle ranged from 7.3% to 46.1%.
Bundle completion was more common in hospitals already treating a relatively high volume of pediatric patients and in those with pediatric specialty services, but the study authors noted that this was not a linear relationship. Rather, they called this association “hypothesis generating” and speculated that other factors might also be important.
The children in this cohort ranged in age from under 1 month to 17 years. Slightly more than half were aged 6 years or older and nearly one-third were older than 12 years. Nearly 45% had no comorbidities. Slightly more than one-third had a malignancy or were immunosuppressed.
None of the study authors reported any relevant financial relationships with industry.
SOURCE: Evans IVR et al. JAMA. 2018 Jul 24. doi:10.1001/jama.2018.9071.
The data published by Evans et al support a protocol approach to sepsis management in children as well as prompt delivery of the components outlined in the New York state mandate, according to an accompanying editorial written by Robert J. Vinci, MD, of Boston Medical Center, and Elliot Melendez, MD, of Johns Hopkins All Children’s Hospital, St. Petersburg, Fla. However, it cannot be determined from this study whether it is prompt delivery of these three mandated components or a more rigorous approach to pediatric sepsis management that deserves the most credit for the mortality benefit.
“Organizations that undertake quality improvement initiatives may have systems of care that promote the bundle completion, which then leads to improved outcomes,” they wrote. As a result, bundle completion may be a marker of expertise in managing critically ill children. They agreed that the data support the tested protocol, but they questioned whether this is sufficient.
“Organizations should be cautious about merely adopting a bundle of care without ensuring they have a universal culture of safety and quality that is adopted and supported from front-line clinical caregivers to organizational leaders and administrators,” they stated.
Dr. Vinci and Dr. Melendez had no disclosures to report.
SOURCE: JAMA. 2018;320(4):345-346. doi:10.1001/jama.2018.9183.
The data published by Evans et al support a protocol approach to sepsis management in children as well as prompt delivery of the components outlined in the New York state mandate, according to an accompanying editorial written by Robert J. Vinci, MD, of Boston Medical Center, and Elliot Melendez, MD, of Johns Hopkins All Children’s Hospital, St. Petersburg, Fla. However, it cannot be determined from this study whether it is prompt delivery of these three mandated components or a more rigorous approach to pediatric sepsis management that deserves the most credit for the mortality benefit.
“Organizations that undertake quality improvement initiatives may have systems of care that promote the bundle completion, which then leads to improved outcomes,” they wrote. As a result, bundle completion may be a marker of expertise in managing critically ill children. They agreed that the data support the tested protocol, but they questioned whether this is sufficient.
“Organizations should be cautious about merely adopting a bundle of care without ensuring they have a universal culture of safety and quality that is adopted and supported from front-line clinical caregivers to organizational leaders and administrators,” they stated.
Dr. Vinci and Dr. Melendez had no disclosures to report.
SOURCE: JAMA. 2018;320(4):345-346. doi:10.1001/jama.2018.9183.
The data published by Evans et al support a protocol approach to sepsis management in children as well as prompt delivery of the components outlined in the New York state mandate, according to an accompanying editorial written by Robert J. Vinci, MD, of Boston Medical Center, and Elliot Melendez, MD, of Johns Hopkins All Children’s Hospital, St. Petersburg, Fla. However, it cannot be determined from this study whether it is prompt delivery of these three mandated components or a more rigorous approach to pediatric sepsis management that deserves the most credit for the mortality benefit.
“Organizations that undertake quality improvement initiatives may have systems of care that promote the bundle completion, which then leads to improved outcomes,” they wrote. As a result, bundle completion may be a marker of expertise in managing critically ill children. They agreed that the data support the tested protocol, but they questioned whether this is sufficient.
“Organizations should be cautious about merely adopting a bundle of care without ensuring they have a universal culture of safety and quality that is adopted and supported from front-line clinical caregivers to organizational leaders and administrators,” they stated.
Dr. Vinci and Dr. Melendez had no disclosures to report.
SOURCE: JAMA. 2018;320(4):345-346. doi:10.1001/jama.2018.9183.
A bundle of blood cultures, broad-spectrum antibiotics, and intravenous fluid replacement reduces risk of in-hospital mortality among children with sepsis if all three forms of management are initiated within an hour, according to a cohort study published in JAMA.
Although published guidelines already recommend prompt initiation of these three elements of care, a mandate created in New York in 2013 called for these interventions to be initiated in children within 1 hour of sepsis recognition. The newly published cohort study shows a mortality benefit when this is done.
In the study, which evaluated the impact of the bundle as well as each of the components in 1,179 pediatric patients with sepsis treated at 54 hospitals, the risk-adjusted odds ratio of in-hospital mortality was 0.59 (P = .02) among patients receiving the mandated protocol, compared with those who did not.
When provided within 1 hour, none of the individual components of the bundles were associated with a significant reduction of risk-adjusted, in-hospital mortality by themselves. However, there were trends for benefit with blood cultures (OR, 0.73; P = .1) and broad-spectrum antibiotics (OR, 0.78; P = .18). There was no trend for administration of intravenous fluids (OR, 0.88; P = .56), for which the mandate specified 20 mL/kg.
Although 46.5% of patients received intravenous fluids, 62.8% received broad-spectrum antibiotics, and blood cultures were obtained in 67.7% of the children within 1 hour, only 24.9% were managed with the entire sepsis bundle. Across hospitals, the proportion of children completing the bundle ranged from 7.3% to 46.1%.
Bundle completion was more common in hospitals already treating a relatively high volume of pediatric patients and in those with pediatric specialty services, but the study authors noted that this was not a linear relationship. Rather, they called this association “hypothesis generating” and speculated that other factors might also be important.
The children in this cohort ranged in age from under 1 month to 17 years. Slightly more than half were aged 6 years or older and nearly one-third were older than 12 years. Nearly 45% had no comorbidities. Slightly more than one-third had a malignancy or were immunosuppressed.
None of the study authors reported any relevant financial relationships with industry.
SOURCE: Evans IVR et al. JAMA. 2018 Jul 24. doi:10.1001/jama.2018.9071.
A bundle of blood cultures, broad-spectrum antibiotics, and intravenous fluid replacement reduces risk of in-hospital mortality among children with sepsis if all three forms of management are initiated within an hour, according to a cohort study published in JAMA.
Although published guidelines already recommend prompt initiation of these three elements of care, a mandate created in New York in 2013 called for these interventions to be initiated in children within 1 hour of sepsis recognition. The newly published cohort study shows a mortality benefit when this is done.
In the study, which evaluated the impact of the bundle as well as each of the components in 1,179 pediatric patients with sepsis treated at 54 hospitals, the risk-adjusted odds ratio of in-hospital mortality was 0.59 (P = .02) among patients receiving the mandated protocol, compared with those who did not.
When provided within 1 hour, none of the individual components of the bundles were associated with a significant reduction of risk-adjusted, in-hospital mortality by themselves. However, there were trends for benefit with blood cultures (OR, 0.73; P = .1) and broad-spectrum antibiotics (OR, 0.78; P = .18). There was no trend for administration of intravenous fluids (OR, 0.88; P = .56), for which the mandate specified 20 mL/kg.
Although 46.5% of patients received intravenous fluids, 62.8% received broad-spectrum antibiotics, and blood cultures were obtained in 67.7% of the children within 1 hour, only 24.9% were managed with the entire sepsis bundle. Across hospitals, the proportion of children completing the bundle ranged from 7.3% to 46.1%.
Bundle completion was more common in hospitals already treating a relatively high volume of pediatric patients and in those with pediatric specialty services, but the study authors noted that this was not a linear relationship. Rather, they called this association “hypothesis generating” and speculated that other factors might also be important.
The children in this cohort ranged in age from under 1 month to 17 years. Slightly more than half were aged 6 years or older and nearly one-third were older than 12 years. Nearly 45% had no comorbidities. Slightly more than one-third had a malignancy or were immunosuppressed.
None of the study authors reported any relevant financial relationships with industry.
SOURCE: Evans IVR et al. JAMA. 2018 Jul 24. doi:10.1001/jama.2018.9071.
FROM JAMA
Key clinical point: Delivery of all three parts of the bundled pediatric sepsis management protocol was required for a mortality benefit.
Major finding: With timely delivery of the complete bundle, the odds ratio for in-hospital mortality was reduced 41% (OR, 0.59; P = .02).
Study details: A cohort study including 1,179 pediatric patients with sepsis at 54 New York hospitals.
Disclosures: None of the study authors reported any relevant financial relationships with industry.
Source: Evans IVR et al. JAMA. 2018 Jul 24. doi:10.1001/jama.2018.9071.
Internist comanagement of orthopedic inpatients boosts outcomes
NEW ORLEANS – Comanagement of orthopedic inpatients by an internist or hospitalist can improve outcomes in myriad ways, Mary Anderson Wallace, MD, said at the annual meeting of the American College of Physicians.
She focused on patients undergoing total hip or knee arthroplasty (THA/TKA). In 2014, there were 400,000 of them under Medicare alone, accounting for $7 billion in hospitalization costs and nearly as much again in the cost of related postdischarge care.
So, changes in management that improve key outcomes in this population by even a small increment reap huge benefits when spread across this enormous patient population, noted Dr. Wallace, an internist and hospitalist at the University of Colorado, Denver.
Among the examples she highlighted where comanagement can have a favorable impact were optimization of perioperative pain management pathways; how to handle the use of disease-modifying antirheumatic drugs (DMARDs) in patients undergoing THA/TKA; the latest thinking on the appropriateness of low-dose aspirin for deep vein thrombosis (DVT) prophylaxis; a simple way to predict postop delirium in older individuals without known dementia; how to decide which postoperative fevers warrant a costly infectious disease workup; and the optimal wait time from arrival at the hospital with a fractured hip and THA.
These are all issues where a well-informed internist/hospitalist can be of enormous assistance to a busy orthopedic surgeon in providing high-value care, she explained.
Optimizing perioperative pain management pathways
As of 2015, orthopedists ranked as the third highest prescribers of opioids. Impressively, a retrospective cohort study of 641,941 opioid-naive, privately insured patients undergoing 1 of 11 types of surgery demonstrated that TKA was associated with a 5.1-fold increased risk for subsequent chronic opioid use in the first year after surgery, compared with 18 million opioid-naive nonsurgical controls. Indeed, TKA was the highest-risk of the 11 surgical procedures examined (JAMA Intern Med. 2016 Sep 1;176[9]:1286-93).
Another study that points to a need to develop best practices for opioid prescribing in orthopedic surgery – and other types of surgery as well – was a systematic review of six studies of patients who received prescription opioid analgesics in conjunction with seven types of surgery.
Opioid oversupply was identified as a clear problem: 67%-92% of patients in the six studies reported unused opioids. Up to 71% of opioid tablets went unused, mainly because patients felt they’d achieved adequate pain control and didn’t need them. Rates of safe disposal of unused opioids were in the single digits, suggesting that overprescribing provides a large potential reservoir of opioids that can be diverted to nonmedical use (JAMA Surg. 2017 Nov 1;152[11]:1066-71).
Moreover, a recent retrospective study of more than 1 million opioid-naive patients undergoing surgery showed that 56% of them received postoperative opioids. And each additional week of use was associated with a 44% increase in the relative risk of the composite endpoint of opioid dependence, abuse, or overdose. Duration of opioid use was a stronger predictor of this adverse outcome than was dosage (BMJ. 2018 Jan 17;360:j5790).
Other studies have shown that multimodal analgesia is utilized in only 25%-50% of surgical patients, even though it is considered the standard of care. Only 20% of patients undergoing THA/TKA receive peripheral nerve and neuraxial blocks. So, there is an opportunity for optimization of perioperative pain management pathways in orthopedic surgery patients, including avoidance of unnecessary p.r.n. prescribing, to favorably impact the national opioid epidemic, Dr. Wallace observed.
A surprise benefit of multimodal pain management that includes acetaminophen and a nonsteroidal anti-inflammatory agent is that it markedly reduces the incidence of postoperative fevers after total joint arthroplasty, compared with opioid-based pain management.
That was demonstrated in a retrospective study of 2,417 THA/TKAs in which multimodal pain management was used, and 1,484 procedures that relied on opioid-based pain relief. All of the operations were performed by the same three orthopedic surgeons. Only 5% of patients in the multimodal pain management group developed a fever greater than 38.5 degrees Celsius during the first 5 postoperative days, compared with 25% of those in the opioid-based analgesia group.
Moreover, an infectious disease workup was ordered in 2% of the multimodal analgesia group, versus 10% in the opioid-based pain management cohort, with no difference in the positive workup rates between the two groups (Clin Orthop Relat Res. 2014 May;472[5]:1489-95).
“It’s interesting that multimodal pain management has the side effect of putting you in a better position to practice high-value care, with less fever and fewer infectious disease workups,” Dr. Wallace said.
Perioperative management of DMARDs
Recent joint guidelines from the American College of Rheumatology and American Association of Hip and Knee Surgeons specifically address this issue in patients undergoing elective joint replacement (Arthritis Rheumatol. 2017 Aug;69[8]:1538-51).
“The quality of evidence isn’t high, but at least it’s a starting point,” Dr. Wallace said.
Patients with rheumatoid arthritis, systemic lupus erythematosus, spondyloarthropathies, and other rheumatic diseases who are on methotrexate or other nonbiologic DMARDs should be maintained on their current dose, according to the guidelines.
In contrast, all biologic agents should be withheld prior to surgery, which should be scheduled to coincide with the end of the dosing cycle for that specific biologic. The biologic agent should be resumed only once adequate wound healing has occurred, typically about 14 days post-THA/TKA.
Patients on daily glucocorticoids should continue on their current dose; supraphysiologic stress dosing is to be avoided.
Low-dose aspirin for VTE prophylaxis
“It seems like nothing has been such an enduring controversy in the comanagement literature as the question of whether aspirin is an effective prophylactic agent for prevention of DVT post THA/TKA,” according to Dr. Wallace.
She noted that in the space of just 4 years between the eighth and ninth editions of the American College of Chest Physician guidelines, that organization underwent a 180-degree reversal on the issue – whipsawing from a grade 1A recommendation against aspirin in 2008 to a 1B recommendation for it in 2012.
The literature is increasingly supportive of the use of aspirin for venous thromboembolism (VTE) prophylaxis in low-risk THA/TKA patients. Separate guidelines from the American Academy of Orthopaedic Surgeons (AAOS) and the Surgical Care Improvement Project, as well as the chest physicians, support the practice.
The hitch is that there is as yet no single validated risk-stratification protocol. AAOS recommends 325 mg of aspirin twice daily for 6 weeks. But a prospective crossover study of more than 4,600 total joint arthroplasty patients conducted by investigators at Thomas Jefferson University in Philadelphia showed that 81 mg BID for 4 weeks was just as effective as was 325 mg b.i.d., albeit with an incidence of GI bleeding that to their surprise wasn’t significantly lower (J Bone Joint Surg Am. 2017 Jan 18;99[2]:91-8).
Dr. Wallace anticipates definitive answers on VTE prophylaxis to come from the ongoing Patient-Centered Outcomes Research Institute-supported PEPPER (Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement) trial. In that study, roughly 25,000 patients undergoing THA/TKA are being randomized to prophylactic aspirin at 81 mg b.i.d., warfarin at an International Normalized Ratio of 2.0, or rivaroxaban (Xarelto). Endpoints include mortality, VTE, and bleeding. Results are expected in 2021.
Preoperative prediction of postop delirium
Unrecognized preoperative cognitive impairment in older patients without dementia who are undergoing THA/TKA is a common and powerful risk factor for postop delirium and other complications, as demonstrated recently by investigators at Harvard University and affiliated hospitals.
They had 211 patients aged 65 or older, none with known dementia, take the Mini-Cog screening test prior to their surgery. Fully 24% had probable cognitive impairment as reflected in a score of 2 or less out of a possible 5 points on this simple test, which consists of a three-word recall and clock drawing.
“I was very surprised at this high rate. These are patients who are at risk for delirium in the hospital when you’re taking care of them,” Dr. Wallace observed.
In the Harvard study, the incidence of postop delirium was 21% in patients with a Mini-Cog score of 2 or less, compared with 7% who scored 3-5, for an odds ratio of 4.5 in an age-adjusted multivariate analysis. Moreover, 67% of the low scorers were discharged somewhere other than home, in contrast to 34% of patients with a preop Mini-Cog score of 3-5, for an adjusted 3.9-fold increased risk. The group with a Mini-Cog score of 2 or less also had a significantly longer hospital length of stay (Anesthesiology. 2017 Nov;127[5]:765-74).
Perioperative gabapentin is often added to the medication regimen of older surgical patients to reduce postop delirium. The latest evidence indicates that doesn’t work, as demonstrated in a recent 697-patient randomized trial. The incidence of delirium during the first 3 days post surgery as measured by the Confusion Assessment Method was 22.4% in patients randomized to 900 mg of gabapentin per day, and 20.8% with placebo. Nearly 200 participants had THA or TKA, and in that subgroup, there was an even stronger – albeit still not statistically significant – trend for a higher delirium rate with gabapentin than with placebo (Anesthesiology. 2017 Oct.127[4]:633-44).
“Think twice about adding gabapentin to the pain regimen for THA/TKA/spine patients for the purpose of preventing postop delirium,” she advised.
When is postop fever a concern?
Up to half of patients develop fever early after THA/TKA. In most cases, this is a self-limited ancillary effect of cytokine release, with the temperature peaking on postop day 1-2.
Three strong predictors of a positive infectious disease workup are fever after postop day 3, with an associated 23.3-fold increased risk; multiple days of fever, with an odds ratio of 8.6; and a maximum temperature greater than 39.0 degrees Celsius, with a 2.4-fold increased risk. In this 7-year-old study, the cost of infectious disease workup per change in patient management was a hefty $8,209 (J Arthroplasty. 2010 Sep;25[6 Suppl]:43-8).
A retrospective study of nearly 125,000 THA/TKA patients in the American College of Surgeons National Surgical Quality Improvement Program database has important implications for clinical surveillance for postop adverse events. Stroke occurred early, on median postop day 1. The median time of acute MI and pulmonary embolism was postop day 3, and pneumonia day 4.
The key take-home message was that the median time to DVT was postop day 6, by which point most patients had been discharged. Thus, 60% of postoperative DVTs occurred after discharge. And the time to diagnosis of DVT differed markedly by surgical procedure: The median day of diagnosis was day 5 in TKA patients, compared with day 13 for THA patients. Sixty-eight percent of urinary tract infections occurred post discharge. Sepsis occurred on median day 10 post surgery, surgical site infections on day 17 (Clin Orthop Relat Res. 2017 Dec;475[12]:2952-9).
In light of ever-shortening hospital lengths of stay, Dr. Wallace noted, the findings underscore the importance of comprehensive predischarge patient counseling.
Optimal time window for hip fracture surgery
AAOS guidelines recommend that hip fracture surgery should take place within 48 hours, assuming medical comorbidities are stabilized, because complication rates go up with longer wait times.
But that is controversial. A University of Toronto retrospective cohort study of 42,430 adults with hip fracture treated at 72 Canadian hospitals during 2009-2014 found that the inflection point was 24 hours. Among 13,731 patients whose elapsed time from hospital arrival to surgery was 24 hours or less, 30-day mortality was 5.8%, significantly less than the 6.5% rate in an equal number of propensity score–matched patients with a longer wait time.
The 90- and 365-day mortality rates in the patients who received surgery within 24 hours were 10.7% and 19.3%, both significantly lower than the 12.0% and 21.6% figures in patients with longer wait times.
For the 30-day composite outcome of death, myocardial infarction, pulmonary embolism, DVT, or pneumonia, the rates were 10.1% and 12.2% – again, statistically significant and clinically meaningful. The 90- and 365-day composite outcomes followed suit (JAMA. 2017 Nov 28;318[20]:1994-2003).
But the Canadian study won’t be the final word. The ongoing international multicenter HIP ATTACK (Hip Fracture Accelerated Surgical Treatment and Care Track) trial is comparing outcomes in 3,000 patients randomized to hip fracture surgery within 6 hours versus 24 hours. Endpoints include mortality, myocardial infarction, pulmonary embolism, pneumonia, stroke, sepsis, and life-threatening and major bleeding.
Dr. Wallace reported having no financial conflicts regarding her presentation.
NEW ORLEANS – Comanagement of orthopedic inpatients by an internist or hospitalist can improve outcomes in myriad ways, Mary Anderson Wallace, MD, said at the annual meeting of the American College of Physicians.
She focused on patients undergoing total hip or knee arthroplasty (THA/TKA). In 2014, there were 400,000 of them under Medicare alone, accounting for $7 billion in hospitalization costs and nearly as much again in the cost of related postdischarge care.
So, changes in management that improve key outcomes in this population by even a small increment reap huge benefits when spread across this enormous patient population, noted Dr. Wallace, an internist and hospitalist at the University of Colorado, Denver.
Among the examples she highlighted where comanagement can have a favorable impact were optimization of perioperative pain management pathways; how to handle the use of disease-modifying antirheumatic drugs (DMARDs) in patients undergoing THA/TKA; the latest thinking on the appropriateness of low-dose aspirin for deep vein thrombosis (DVT) prophylaxis; a simple way to predict postop delirium in older individuals without known dementia; how to decide which postoperative fevers warrant a costly infectious disease workup; and the optimal wait time from arrival at the hospital with a fractured hip and THA.
These are all issues where a well-informed internist/hospitalist can be of enormous assistance to a busy orthopedic surgeon in providing high-value care, she explained.
Optimizing perioperative pain management pathways
As of 2015, orthopedists ranked as the third highest prescribers of opioids. Impressively, a retrospective cohort study of 641,941 opioid-naive, privately insured patients undergoing 1 of 11 types of surgery demonstrated that TKA was associated with a 5.1-fold increased risk for subsequent chronic opioid use in the first year after surgery, compared with 18 million opioid-naive nonsurgical controls. Indeed, TKA was the highest-risk of the 11 surgical procedures examined (JAMA Intern Med. 2016 Sep 1;176[9]:1286-93).
Another study that points to a need to develop best practices for opioid prescribing in orthopedic surgery – and other types of surgery as well – was a systematic review of six studies of patients who received prescription opioid analgesics in conjunction with seven types of surgery.
Opioid oversupply was identified as a clear problem: 67%-92% of patients in the six studies reported unused opioids. Up to 71% of opioid tablets went unused, mainly because patients felt they’d achieved adequate pain control and didn’t need them. Rates of safe disposal of unused opioids were in the single digits, suggesting that overprescribing provides a large potential reservoir of opioids that can be diverted to nonmedical use (JAMA Surg. 2017 Nov 1;152[11]:1066-71).
Moreover, a recent retrospective study of more than 1 million opioid-naive patients undergoing surgery showed that 56% of them received postoperative opioids. And each additional week of use was associated with a 44% increase in the relative risk of the composite endpoint of opioid dependence, abuse, or overdose. Duration of opioid use was a stronger predictor of this adverse outcome than was dosage (BMJ. 2018 Jan 17;360:j5790).
Other studies have shown that multimodal analgesia is utilized in only 25%-50% of surgical patients, even though it is considered the standard of care. Only 20% of patients undergoing THA/TKA receive peripheral nerve and neuraxial blocks. So, there is an opportunity for optimization of perioperative pain management pathways in orthopedic surgery patients, including avoidance of unnecessary p.r.n. prescribing, to favorably impact the national opioid epidemic, Dr. Wallace observed.
A surprise benefit of multimodal pain management that includes acetaminophen and a nonsteroidal anti-inflammatory agent is that it markedly reduces the incidence of postoperative fevers after total joint arthroplasty, compared with opioid-based pain management.
That was demonstrated in a retrospective study of 2,417 THA/TKAs in which multimodal pain management was used, and 1,484 procedures that relied on opioid-based pain relief. All of the operations were performed by the same three orthopedic surgeons. Only 5% of patients in the multimodal pain management group developed a fever greater than 38.5 degrees Celsius during the first 5 postoperative days, compared with 25% of those in the opioid-based analgesia group.
Moreover, an infectious disease workup was ordered in 2% of the multimodal analgesia group, versus 10% in the opioid-based pain management cohort, with no difference in the positive workup rates between the two groups (Clin Orthop Relat Res. 2014 May;472[5]:1489-95).
“It’s interesting that multimodal pain management has the side effect of putting you in a better position to practice high-value care, with less fever and fewer infectious disease workups,” Dr. Wallace said.
Perioperative management of DMARDs
Recent joint guidelines from the American College of Rheumatology and American Association of Hip and Knee Surgeons specifically address this issue in patients undergoing elective joint replacement (Arthritis Rheumatol. 2017 Aug;69[8]:1538-51).
“The quality of evidence isn’t high, but at least it’s a starting point,” Dr. Wallace said.
Patients with rheumatoid arthritis, systemic lupus erythematosus, spondyloarthropathies, and other rheumatic diseases who are on methotrexate or other nonbiologic DMARDs should be maintained on their current dose, according to the guidelines.
In contrast, all biologic agents should be withheld prior to surgery, which should be scheduled to coincide with the end of the dosing cycle for that specific biologic. The biologic agent should be resumed only once adequate wound healing has occurred, typically about 14 days post-THA/TKA.
Patients on daily glucocorticoids should continue on their current dose; supraphysiologic stress dosing is to be avoided.
Low-dose aspirin for VTE prophylaxis
“It seems like nothing has been such an enduring controversy in the comanagement literature as the question of whether aspirin is an effective prophylactic agent for prevention of DVT post THA/TKA,” according to Dr. Wallace.
She noted that in the space of just 4 years between the eighth and ninth editions of the American College of Chest Physician guidelines, that organization underwent a 180-degree reversal on the issue – whipsawing from a grade 1A recommendation against aspirin in 2008 to a 1B recommendation for it in 2012.
The literature is increasingly supportive of the use of aspirin for venous thromboembolism (VTE) prophylaxis in low-risk THA/TKA patients. Separate guidelines from the American Academy of Orthopaedic Surgeons (AAOS) and the Surgical Care Improvement Project, as well as the chest physicians, support the practice.
The hitch is that there is as yet no single validated risk-stratification protocol. AAOS recommends 325 mg of aspirin twice daily for 6 weeks. But a prospective crossover study of more than 4,600 total joint arthroplasty patients conducted by investigators at Thomas Jefferson University in Philadelphia showed that 81 mg BID for 4 weeks was just as effective as was 325 mg b.i.d., albeit with an incidence of GI bleeding that to their surprise wasn’t significantly lower (J Bone Joint Surg Am. 2017 Jan 18;99[2]:91-8).
Dr. Wallace anticipates definitive answers on VTE prophylaxis to come from the ongoing Patient-Centered Outcomes Research Institute-supported PEPPER (Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement) trial. In that study, roughly 25,000 patients undergoing THA/TKA are being randomized to prophylactic aspirin at 81 mg b.i.d., warfarin at an International Normalized Ratio of 2.0, or rivaroxaban (Xarelto). Endpoints include mortality, VTE, and bleeding. Results are expected in 2021.
Preoperative prediction of postop delirium
Unrecognized preoperative cognitive impairment in older patients without dementia who are undergoing THA/TKA is a common and powerful risk factor for postop delirium and other complications, as demonstrated recently by investigators at Harvard University and affiliated hospitals.
They had 211 patients aged 65 or older, none with known dementia, take the Mini-Cog screening test prior to their surgery. Fully 24% had probable cognitive impairment as reflected in a score of 2 or less out of a possible 5 points on this simple test, which consists of a three-word recall and clock drawing.
“I was very surprised at this high rate. These are patients who are at risk for delirium in the hospital when you’re taking care of them,” Dr. Wallace observed.
In the Harvard study, the incidence of postop delirium was 21% in patients with a Mini-Cog score of 2 or less, compared with 7% who scored 3-5, for an odds ratio of 4.5 in an age-adjusted multivariate analysis. Moreover, 67% of the low scorers were discharged somewhere other than home, in contrast to 34% of patients with a preop Mini-Cog score of 3-5, for an adjusted 3.9-fold increased risk. The group with a Mini-Cog score of 2 or less also had a significantly longer hospital length of stay (Anesthesiology. 2017 Nov;127[5]:765-74).
Perioperative gabapentin is often added to the medication regimen of older surgical patients to reduce postop delirium. The latest evidence indicates that doesn’t work, as demonstrated in a recent 697-patient randomized trial. The incidence of delirium during the first 3 days post surgery as measured by the Confusion Assessment Method was 22.4% in patients randomized to 900 mg of gabapentin per day, and 20.8% with placebo. Nearly 200 participants had THA or TKA, and in that subgroup, there was an even stronger – albeit still not statistically significant – trend for a higher delirium rate with gabapentin than with placebo (Anesthesiology. 2017 Oct.127[4]:633-44).
“Think twice about adding gabapentin to the pain regimen for THA/TKA/spine patients for the purpose of preventing postop delirium,” she advised.
When is postop fever a concern?
Up to half of patients develop fever early after THA/TKA. In most cases, this is a self-limited ancillary effect of cytokine release, with the temperature peaking on postop day 1-2.
Three strong predictors of a positive infectious disease workup are fever after postop day 3, with an associated 23.3-fold increased risk; multiple days of fever, with an odds ratio of 8.6; and a maximum temperature greater than 39.0 degrees Celsius, with a 2.4-fold increased risk. In this 7-year-old study, the cost of infectious disease workup per change in patient management was a hefty $8,209 (J Arthroplasty. 2010 Sep;25[6 Suppl]:43-8).
A retrospective study of nearly 125,000 THA/TKA patients in the American College of Surgeons National Surgical Quality Improvement Program database has important implications for clinical surveillance for postop adverse events. Stroke occurred early, on median postop day 1. The median time of acute MI and pulmonary embolism was postop day 3, and pneumonia day 4.
The key take-home message was that the median time to DVT was postop day 6, by which point most patients had been discharged. Thus, 60% of postoperative DVTs occurred after discharge. And the time to diagnosis of DVT differed markedly by surgical procedure: The median day of diagnosis was day 5 in TKA patients, compared with day 13 for THA patients. Sixty-eight percent of urinary tract infections occurred post discharge. Sepsis occurred on median day 10 post surgery, surgical site infections on day 17 (Clin Orthop Relat Res. 2017 Dec;475[12]:2952-9).
In light of ever-shortening hospital lengths of stay, Dr. Wallace noted, the findings underscore the importance of comprehensive predischarge patient counseling.
Optimal time window for hip fracture surgery
AAOS guidelines recommend that hip fracture surgery should take place within 48 hours, assuming medical comorbidities are stabilized, because complication rates go up with longer wait times.
But that is controversial. A University of Toronto retrospective cohort study of 42,430 adults with hip fracture treated at 72 Canadian hospitals during 2009-2014 found that the inflection point was 24 hours. Among 13,731 patients whose elapsed time from hospital arrival to surgery was 24 hours or less, 30-day mortality was 5.8%, significantly less than the 6.5% rate in an equal number of propensity score–matched patients with a longer wait time.
The 90- and 365-day mortality rates in the patients who received surgery within 24 hours were 10.7% and 19.3%, both significantly lower than the 12.0% and 21.6% figures in patients with longer wait times.
For the 30-day composite outcome of death, myocardial infarction, pulmonary embolism, DVT, or pneumonia, the rates were 10.1% and 12.2% – again, statistically significant and clinically meaningful. The 90- and 365-day composite outcomes followed suit (JAMA. 2017 Nov 28;318[20]:1994-2003).
But the Canadian study won’t be the final word. The ongoing international multicenter HIP ATTACK (Hip Fracture Accelerated Surgical Treatment and Care Track) trial is comparing outcomes in 3,000 patients randomized to hip fracture surgery within 6 hours versus 24 hours. Endpoints include mortality, myocardial infarction, pulmonary embolism, pneumonia, stroke, sepsis, and life-threatening and major bleeding.
Dr. Wallace reported having no financial conflicts regarding her presentation.
NEW ORLEANS – Comanagement of orthopedic inpatients by an internist or hospitalist can improve outcomes in myriad ways, Mary Anderson Wallace, MD, said at the annual meeting of the American College of Physicians.
She focused on patients undergoing total hip or knee arthroplasty (THA/TKA). In 2014, there were 400,000 of them under Medicare alone, accounting for $7 billion in hospitalization costs and nearly as much again in the cost of related postdischarge care.
So, changes in management that improve key outcomes in this population by even a small increment reap huge benefits when spread across this enormous patient population, noted Dr. Wallace, an internist and hospitalist at the University of Colorado, Denver.
Among the examples she highlighted where comanagement can have a favorable impact were optimization of perioperative pain management pathways; how to handle the use of disease-modifying antirheumatic drugs (DMARDs) in patients undergoing THA/TKA; the latest thinking on the appropriateness of low-dose aspirin for deep vein thrombosis (DVT) prophylaxis; a simple way to predict postop delirium in older individuals without known dementia; how to decide which postoperative fevers warrant a costly infectious disease workup; and the optimal wait time from arrival at the hospital with a fractured hip and THA.
These are all issues where a well-informed internist/hospitalist can be of enormous assistance to a busy orthopedic surgeon in providing high-value care, she explained.
Optimizing perioperative pain management pathways
As of 2015, orthopedists ranked as the third highest prescribers of opioids. Impressively, a retrospective cohort study of 641,941 opioid-naive, privately insured patients undergoing 1 of 11 types of surgery demonstrated that TKA was associated with a 5.1-fold increased risk for subsequent chronic opioid use in the first year after surgery, compared with 18 million opioid-naive nonsurgical controls. Indeed, TKA was the highest-risk of the 11 surgical procedures examined (JAMA Intern Med. 2016 Sep 1;176[9]:1286-93).
Another study that points to a need to develop best practices for opioid prescribing in orthopedic surgery – and other types of surgery as well – was a systematic review of six studies of patients who received prescription opioid analgesics in conjunction with seven types of surgery.
Opioid oversupply was identified as a clear problem: 67%-92% of patients in the six studies reported unused opioids. Up to 71% of opioid tablets went unused, mainly because patients felt they’d achieved adequate pain control and didn’t need them. Rates of safe disposal of unused opioids were in the single digits, suggesting that overprescribing provides a large potential reservoir of opioids that can be diverted to nonmedical use (JAMA Surg. 2017 Nov 1;152[11]:1066-71).
Moreover, a recent retrospective study of more than 1 million opioid-naive patients undergoing surgery showed that 56% of them received postoperative opioids. And each additional week of use was associated with a 44% increase in the relative risk of the composite endpoint of opioid dependence, abuse, or overdose. Duration of opioid use was a stronger predictor of this adverse outcome than was dosage (BMJ. 2018 Jan 17;360:j5790).
Other studies have shown that multimodal analgesia is utilized in only 25%-50% of surgical patients, even though it is considered the standard of care. Only 20% of patients undergoing THA/TKA receive peripheral nerve and neuraxial blocks. So, there is an opportunity for optimization of perioperative pain management pathways in orthopedic surgery patients, including avoidance of unnecessary p.r.n. prescribing, to favorably impact the national opioid epidemic, Dr. Wallace observed.
A surprise benefit of multimodal pain management that includes acetaminophen and a nonsteroidal anti-inflammatory agent is that it markedly reduces the incidence of postoperative fevers after total joint arthroplasty, compared with opioid-based pain management.
That was demonstrated in a retrospective study of 2,417 THA/TKAs in which multimodal pain management was used, and 1,484 procedures that relied on opioid-based pain relief. All of the operations were performed by the same three orthopedic surgeons. Only 5% of patients in the multimodal pain management group developed a fever greater than 38.5 degrees Celsius during the first 5 postoperative days, compared with 25% of those in the opioid-based analgesia group.
Moreover, an infectious disease workup was ordered in 2% of the multimodal analgesia group, versus 10% in the opioid-based pain management cohort, with no difference in the positive workup rates between the two groups (Clin Orthop Relat Res. 2014 May;472[5]:1489-95).
“It’s interesting that multimodal pain management has the side effect of putting you in a better position to practice high-value care, with less fever and fewer infectious disease workups,” Dr. Wallace said.
Perioperative management of DMARDs
Recent joint guidelines from the American College of Rheumatology and American Association of Hip and Knee Surgeons specifically address this issue in patients undergoing elective joint replacement (Arthritis Rheumatol. 2017 Aug;69[8]:1538-51).
“The quality of evidence isn’t high, but at least it’s a starting point,” Dr. Wallace said.
Patients with rheumatoid arthritis, systemic lupus erythematosus, spondyloarthropathies, and other rheumatic diseases who are on methotrexate or other nonbiologic DMARDs should be maintained on their current dose, according to the guidelines.
In contrast, all biologic agents should be withheld prior to surgery, which should be scheduled to coincide with the end of the dosing cycle for that specific biologic. The biologic agent should be resumed only once adequate wound healing has occurred, typically about 14 days post-THA/TKA.
Patients on daily glucocorticoids should continue on their current dose; supraphysiologic stress dosing is to be avoided.
Low-dose aspirin for VTE prophylaxis
“It seems like nothing has been such an enduring controversy in the comanagement literature as the question of whether aspirin is an effective prophylactic agent for prevention of DVT post THA/TKA,” according to Dr. Wallace.
She noted that in the space of just 4 years between the eighth and ninth editions of the American College of Chest Physician guidelines, that organization underwent a 180-degree reversal on the issue – whipsawing from a grade 1A recommendation against aspirin in 2008 to a 1B recommendation for it in 2012.
The literature is increasingly supportive of the use of aspirin for venous thromboembolism (VTE) prophylaxis in low-risk THA/TKA patients. Separate guidelines from the American Academy of Orthopaedic Surgeons (AAOS) and the Surgical Care Improvement Project, as well as the chest physicians, support the practice.
The hitch is that there is as yet no single validated risk-stratification protocol. AAOS recommends 325 mg of aspirin twice daily for 6 weeks. But a prospective crossover study of more than 4,600 total joint arthroplasty patients conducted by investigators at Thomas Jefferson University in Philadelphia showed that 81 mg BID for 4 weeks was just as effective as was 325 mg b.i.d., albeit with an incidence of GI bleeding that to their surprise wasn’t significantly lower (J Bone Joint Surg Am. 2017 Jan 18;99[2]:91-8).
Dr. Wallace anticipates definitive answers on VTE prophylaxis to come from the ongoing Patient-Centered Outcomes Research Institute-supported PEPPER (Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement) trial. In that study, roughly 25,000 patients undergoing THA/TKA are being randomized to prophylactic aspirin at 81 mg b.i.d., warfarin at an International Normalized Ratio of 2.0, or rivaroxaban (Xarelto). Endpoints include mortality, VTE, and bleeding. Results are expected in 2021.
Preoperative prediction of postop delirium
Unrecognized preoperative cognitive impairment in older patients without dementia who are undergoing THA/TKA is a common and powerful risk factor for postop delirium and other complications, as demonstrated recently by investigators at Harvard University and affiliated hospitals.
They had 211 patients aged 65 or older, none with known dementia, take the Mini-Cog screening test prior to their surgery. Fully 24% had probable cognitive impairment as reflected in a score of 2 or less out of a possible 5 points on this simple test, which consists of a three-word recall and clock drawing.
“I was very surprised at this high rate. These are patients who are at risk for delirium in the hospital when you’re taking care of them,” Dr. Wallace observed.
In the Harvard study, the incidence of postop delirium was 21% in patients with a Mini-Cog score of 2 or less, compared with 7% who scored 3-5, for an odds ratio of 4.5 in an age-adjusted multivariate analysis. Moreover, 67% of the low scorers were discharged somewhere other than home, in contrast to 34% of patients with a preop Mini-Cog score of 3-5, for an adjusted 3.9-fold increased risk. The group with a Mini-Cog score of 2 or less also had a significantly longer hospital length of stay (Anesthesiology. 2017 Nov;127[5]:765-74).
Perioperative gabapentin is often added to the medication regimen of older surgical patients to reduce postop delirium. The latest evidence indicates that doesn’t work, as demonstrated in a recent 697-patient randomized trial. The incidence of delirium during the first 3 days post surgery as measured by the Confusion Assessment Method was 22.4% in patients randomized to 900 mg of gabapentin per day, and 20.8% with placebo. Nearly 200 participants had THA or TKA, and in that subgroup, there was an even stronger – albeit still not statistically significant – trend for a higher delirium rate with gabapentin than with placebo (Anesthesiology. 2017 Oct.127[4]:633-44).
“Think twice about adding gabapentin to the pain regimen for THA/TKA/spine patients for the purpose of preventing postop delirium,” she advised.
When is postop fever a concern?
Up to half of patients develop fever early after THA/TKA. In most cases, this is a self-limited ancillary effect of cytokine release, with the temperature peaking on postop day 1-2.
Three strong predictors of a positive infectious disease workup are fever after postop day 3, with an associated 23.3-fold increased risk; multiple days of fever, with an odds ratio of 8.6; and a maximum temperature greater than 39.0 degrees Celsius, with a 2.4-fold increased risk. In this 7-year-old study, the cost of infectious disease workup per change in patient management was a hefty $8,209 (J Arthroplasty. 2010 Sep;25[6 Suppl]:43-8).
A retrospective study of nearly 125,000 THA/TKA patients in the American College of Surgeons National Surgical Quality Improvement Program database has important implications for clinical surveillance for postop adverse events. Stroke occurred early, on median postop day 1. The median time of acute MI and pulmonary embolism was postop day 3, and pneumonia day 4.
The key take-home message was that the median time to DVT was postop day 6, by which point most patients had been discharged. Thus, 60% of postoperative DVTs occurred after discharge. And the time to diagnosis of DVT differed markedly by surgical procedure: The median day of diagnosis was day 5 in TKA patients, compared with day 13 for THA patients. Sixty-eight percent of urinary tract infections occurred post discharge. Sepsis occurred on median day 10 post surgery, surgical site infections on day 17 (Clin Orthop Relat Res. 2017 Dec;475[12]:2952-9).
In light of ever-shortening hospital lengths of stay, Dr. Wallace noted, the findings underscore the importance of comprehensive predischarge patient counseling.
Optimal time window for hip fracture surgery
AAOS guidelines recommend that hip fracture surgery should take place within 48 hours, assuming medical comorbidities are stabilized, because complication rates go up with longer wait times.
But that is controversial. A University of Toronto retrospective cohort study of 42,430 adults with hip fracture treated at 72 Canadian hospitals during 2009-2014 found that the inflection point was 24 hours. Among 13,731 patients whose elapsed time from hospital arrival to surgery was 24 hours or less, 30-day mortality was 5.8%, significantly less than the 6.5% rate in an equal number of propensity score–matched patients with a longer wait time.
The 90- and 365-day mortality rates in the patients who received surgery within 24 hours were 10.7% and 19.3%, both significantly lower than the 12.0% and 21.6% figures in patients with longer wait times.
For the 30-day composite outcome of death, myocardial infarction, pulmonary embolism, DVT, or pneumonia, the rates were 10.1% and 12.2% – again, statistically significant and clinically meaningful. The 90- and 365-day composite outcomes followed suit (JAMA. 2017 Nov 28;318[20]:1994-2003).
But the Canadian study won’t be the final word. The ongoing international multicenter HIP ATTACK (Hip Fracture Accelerated Surgical Treatment and Care Track) trial is comparing outcomes in 3,000 patients randomized to hip fracture surgery within 6 hours versus 24 hours. Endpoints include mortality, myocardial infarction, pulmonary embolism, pneumonia, stroke, sepsis, and life-threatening and major bleeding.
Dr. Wallace reported having no financial conflicts regarding her presentation.
REPORTING FROM ACP INTERNAL MEDICINE
Epinephrine for cardiac arrest: Better survival, more brain damage
Using epinephrine for cardiac arrest improves 30-day survival by less than 1%, and nearly doubles the risk of severe brain damage among survivors, according to PARAMEDIC2, a randomized, double-blind trial in more than 8,000 patients in Great Britain.
It’s clear what patients want. “Our own work with patients and the public before starting the trial identified survival without brain damage [as] more important to patients than survival alone. The findings of this trial will require careful consideration by the wider community and those responsible for clinical practice guidelines for cardiac arrest,” lead investigator Gavin D. Perkins, MD, professor of critical care medicine at the University of Warwick, Coventry, England, and lead author of the study published in the New England Journal of Medicine, wrote in a statement.
In PARAMEDIC2, after initial attempts with CPR and defibrillation failed, 4,012 patients were given epinephrine 1 mg by intravenous or intraosseous infusion every 3-5 minutes for a maximum of 10 doses, and 3,995 were given a saline placebo in the same fashion. The median time from emergency call to ambulance arrival was just over 6 minutes in both groups, with a further 14 minutes until drug administration.
The heart restarted in a higher proportion of epinephrine patients (36.3% vs. 11.7%), and 3.2% of epinephrine patients were alive at 30 days, versus 2.4% in the placebo arm, a 39% increase.
However, that slight benefit came at a significant cost. Of the 126 epinephrine patients who survived to hospital discharge, 39 (31%) had severe brain damage, compared with 16 (17.8%) among the 90 placebo survivors. Severe brain damage meant inability to walk and tend to bodily functions, or a persistent vegetative state (modified Rankin scale grade 4 or 5).
The trial addresses a long-standing question in resuscitation medicine, the role of epinephrine in cardiac arrest. It’s a devil’s bargain: Epinephrine increases blood flow to the heart, so helps with resuscitation, but it also reduces blood flow in the brain’s microvasculature, increasing the risk of brain damage.
“The benefit of epinephrine on survival demonstrated in this trial should be considered in comparison with other treatments in the chain of survival.” Early cardiac arrest recognition saves 1 in every 11 patients, bystander CPR saves 1 in every 15, and early defibrillation saves 1 in 5, the investigators noted.
The trial did not collect data on prearrest neurologic status, but the number of subjects with impaired function was probably very small and balanced between the groups, according to the report.
On average, patients were aged just under 70 years, 65% were men, and bystander CPR was performed in about 60% in both groups. They were enrolled by five ambulance services in England and Wales. Informed consent was obtained, when possible, after resuscitation.
The trial was funded by the U.K. National Institute for Health Research. The researchers had no relevant disclosures to report.
SOURCE: Perkins GD et al. N Engl J Med. 2018 Jul 18. doi:10.1056/NEJMoa1806842.
Epinephrine has been used in resuscitation efforts since the 1960s, yet no reliable evidence on the practice has been collected. Now, PARAMEDIC2 provides the most rigorous data on patient-centered outcomes with respect to epinephrine to date.
Epinephrine increased 30-day survival in patients with nonshockable rhythms by more than 100%, but the benefit was less clear in those with shockable rhythms. Shockable rhythms are more likely to occur in patients with cardiac or cardiovascular causes of arrest, which epinephrine may exacerbate. The results underscore the principle that drug administration should not compete with or delay defibrillation, and that epinephrine may have different effects in patients with different ECG rhythms.
The PARAMEDIC2 results leave us with several questions: Could other, additional treatments after a return of spontaneous circulation improve functional recovery, should drug use differ on the basis of cardiac rhythm, and would lower doses of epinephrine be superior to higher doses among patients with out-of-hospital cardiac arrest?
Clifton W. Callaway, MD, PhD, of the University of Pittsburgh, and Michael W. Donnino, MD, of Beth Israel Deaconess Medical Center, Boston, made these comments in an accompanying editorial (N Engl J Med. 2018 Jul 18. doi: 10.1056/NEJMe1808255). They had no relevant disclosures.
Epinephrine has been used in resuscitation efforts since the 1960s, yet no reliable evidence on the practice has been collected. Now, PARAMEDIC2 provides the most rigorous data on patient-centered outcomes with respect to epinephrine to date.
Epinephrine increased 30-day survival in patients with nonshockable rhythms by more than 100%, but the benefit was less clear in those with shockable rhythms. Shockable rhythms are more likely to occur in patients with cardiac or cardiovascular causes of arrest, which epinephrine may exacerbate. The results underscore the principle that drug administration should not compete with or delay defibrillation, and that epinephrine may have different effects in patients with different ECG rhythms.
The PARAMEDIC2 results leave us with several questions: Could other, additional treatments after a return of spontaneous circulation improve functional recovery, should drug use differ on the basis of cardiac rhythm, and would lower doses of epinephrine be superior to higher doses among patients with out-of-hospital cardiac arrest?
Clifton W. Callaway, MD, PhD, of the University of Pittsburgh, and Michael W. Donnino, MD, of Beth Israel Deaconess Medical Center, Boston, made these comments in an accompanying editorial (N Engl J Med. 2018 Jul 18. doi: 10.1056/NEJMe1808255). They had no relevant disclosures.
Epinephrine has been used in resuscitation efforts since the 1960s, yet no reliable evidence on the practice has been collected. Now, PARAMEDIC2 provides the most rigorous data on patient-centered outcomes with respect to epinephrine to date.
Epinephrine increased 30-day survival in patients with nonshockable rhythms by more than 100%, but the benefit was less clear in those with shockable rhythms. Shockable rhythms are more likely to occur in patients with cardiac or cardiovascular causes of arrest, which epinephrine may exacerbate. The results underscore the principle that drug administration should not compete with or delay defibrillation, and that epinephrine may have different effects in patients with different ECG rhythms.
The PARAMEDIC2 results leave us with several questions: Could other, additional treatments after a return of spontaneous circulation improve functional recovery, should drug use differ on the basis of cardiac rhythm, and would lower doses of epinephrine be superior to higher doses among patients with out-of-hospital cardiac arrest?
Clifton W. Callaway, MD, PhD, of the University of Pittsburgh, and Michael W. Donnino, MD, of Beth Israel Deaconess Medical Center, Boston, made these comments in an accompanying editorial (N Engl J Med. 2018 Jul 18. doi: 10.1056/NEJMe1808255). They had no relevant disclosures.
Using epinephrine for cardiac arrest improves 30-day survival by less than 1%, and nearly doubles the risk of severe brain damage among survivors, according to PARAMEDIC2, a randomized, double-blind trial in more than 8,000 patients in Great Britain.
It’s clear what patients want. “Our own work with patients and the public before starting the trial identified survival without brain damage [as] more important to patients than survival alone. The findings of this trial will require careful consideration by the wider community and those responsible for clinical practice guidelines for cardiac arrest,” lead investigator Gavin D. Perkins, MD, professor of critical care medicine at the University of Warwick, Coventry, England, and lead author of the study published in the New England Journal of Medicine, wrote in a statement.
In PARAMEDIC2, after initial attempts with CPR and defibrillation failed, 4,012 patients were given epinephrine 1 mg by intravenous or intraosseous infusion every 3-5 minutes for a maximum of 10 doses, and 3,995 were given a saline placebo in the same fashion. The median time from emergency call to ambulance arrival was just over 6 minutes in both groups, with a further 14 minutes until drug administration.
The heart restarted in a higher proportion of epinephrine patients (36.3% vs. 11.7%), and 3.2% of epinephrine patients were alive at 30 days, versus 2.4% in the placebo arm, a 39% increase.
However, that slight benefit came at a significant cost. Of the 126 epinephrine patients who survived to hospital discharge, 39 (31%) had severe brain damage, compared with 16 (17.8%) among the 90 placebo survivors. Severe brain damage meant inability to walk and tend to bodily functions, or a persistent vegetative state (modified Rankin scale grade 4 or 5).
The trial addresses a long-standing question in resuscitation medicine, the role of epinephrine in cardiac arrest. It’s a devil’s bargain: Epinephrine increases blood flow to the heart, so helps with resuscitation, but it also reduces blood flow in the brain’s microvasculature, increasing the risk of brain damage.
“The benefit of epinephrine on survival demonstrated in this trial should be considered in comparison with other treatments in the chain of survival.” Early cardiac arrest recognition saves 1 in every 11 patients, bystander CPR saves 1 in every 15, and early defibrillation saves 1 in 5, the investigators noted.
The trial did not collect data on prearrest neurologic status, but the number of subjects with impaired function was probably very small and balanced between the groups, according to the report.
On average, patients were aged just under 70 years, 65% were men, and bystander CPR was performed in about 60% in both groups. They were enrolled by five ambulance services in England and Wales. Informed consent was obtained, when possible, after resuscitation.
The trial was funded by the U.K. National Institute for Health Research. The researchers had no relevant disclosures to report.
SOURCE: Perkins GD et al. N Engl J Med. 2018 Jul 18. doi:10.1056/NEJMoa1806842.
Using epinephrine for cardiac arrest improves 30-day survival by less than 1%, and nearly doubles the risk of severe brain damage among survivors, according to PARAMEDIC2, a randomized, double-blind trial in more than 8,000 patients in Great Britain.
It’s clear what patients want. “Our own work with patients and the public before starting the trial identified survival without brain damage [as] more important to patients than survival alone. The findings of this trial will require careful consideration by the wider community and those responsible for clinical practice guidelines for cardiac arrest,” lead investigator Gavin D. Perkins, MD, professor of critical care medicine at the University of Warwick, Coventry, England, and lead author of the study published in the New England Journal of Medicine, wrote in a statement.
In PARAMEDIC2, after initial attempts with CPR and defibrillation failed, 4,012 patients were given epinephrine 1 mg by intravenous or intraosseous infusion every 3-5 minutes for a maximum of 10 doses, and 3,995 were given a saline placebo in the same fashion. The median time from emergency call to ambulance arrival was just over 6 minutes in both groups, with a further 14 minutes until drug administration.
The heart restarted in a higher proportion of epinephrine patients (36.3% vs. 11.7%), and 3.2% of epinephrine patients were alive at 30 days, versus 2.4% in the placebo arm, a 39% increase.
However, that slight benefit came at a significant cost. Of the 126 epinephrine patients who survived to hospital discharge, 39 (31%) had severe brain damage, compared with 16 (17.8%) among the 90 placebo survivors. Severe brain damage meant inability to walk and tend to bodily functions, or a persistent vegetative state (modified Rankin scale grade 4 or 5).
The trial addresses a long-standing question in resuscitation medicine, the role of epinephrine in cardiac arrest. It’s a devil’s bargain: Epinephrine increases blood flow to the heart, so helps with resuscitation, but it also reduces blood flow in the brain’s microvasculature, increasing the risk of brain damage.
“The benefit of epinephrine on survival demonstrated in this trial should be considered in comparison with other treatments in the chain of survival.” Early cardiac arrest recognition saves 1 in every 11 patients, bystander CPR saves 1 in every 15, and early defibrillation saves 1 in 5, the investigators noted.
The trial did not collect data on prearrest neurologic status, but the number of subjects with impaired function was probably very small and balanced between the groups, according to the report.
On average, patients were aged just under 70 years, 65% were men, and bystander CPR was performed in about 60% in both groups. They were enrolled by five ambulance services in England and Wales. Informed consent was obtained, when possible, after resuscitation.
The trial was funded by the U.K. National Institute for Health Research. The researchers had no relevant disclosures to report.
SOURCE: Perkins GD et al. N Engl J Med. 2018 Jul 18. doi:10.1056/NEJMoa1806842.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: Of the 128 epinephrine patients who survived to hospital discharge, 39 (30.1%) had severe brain damage, compared with 16 (18.7%) among the 91 placebo survivors.
Study details: A randomized, double-blind trial of over 8,000 U.K. patients experiencing an out-of-hospital cardiac arrest.
Disclosures: The trial was funded by the U.K. National Institute for Health Research. The researchers had no relevant disclosures to report.
Source: Perkins GD et al. N Engl J Med. 2018 Jul 18. doi:10.1056/NEJMoa1806842.
National Academies issues 5-step plan to address infections linked to opioid use disorder
Widespread opioid use disorder (OUD) has spawned new epidemics of hepatitis C virus (HCV) and HIV infections as well as increased hospitalizations for bacteremia, endocarditis, skin and soft tissue infections, and osteomyelitis, according to a report arising from a National Academies of Science, Engineering and Medicine (NASEM) workshop titled Integrating Infectious Disease Considerations with Response to the Opioid Epidemic.
Optimal treatment of these infections is often impeded by untreated OUD, Sandra A. Springer, MD, and her colleagues wrote in an article published online in the Annals of Internal Medicine. Failing to address OUD can result in longer hospital stays; frequent readmissions because of a lack of adherence to antibiotic regimens; or reinfection, morbidity, and high costs. “Medical settings that manage such infections offer a potential means of engaging people in treatment of OUD; however, few providers and hospitals treating such infections have the needed resources and capabilities,” Dr. Springer, director, infectious disease outpatient clinic, Veterans Administration, Newington, and of Yale University, New Haven, both in Conn., and her colleagues wrote.
The authors outlined five action steps resulting from the NASEM workshop:
- Implement screening for OUD in all relevant health care settings.
- For patients with positive screening results, immediately prescribe effective medication for OUD and/or opioid withdrawal symptoms.
- Develop hospital-based protocols that facilitate OUD treatment initiation and linkage to community-based treatment upon discharge.
- Hospitals, medical schools, physician assistant schools, nursing schools, and residency programs should increase training to identify and treat OUD.
- Increase access to addiction care and funding to states to provide effective medications to treat OUD.
Opioid withdrawal and pain syndromes should be addressed with opioid agonist therapies to optimize infectious disease (ID) treatment and relieve pain, according to Dr. Springer and her colleagues. In addition, “Because ID specialists are likely to be consulted for anyone requiring long-term antibiotic therapy or patients with HIV and HCV infection, OUD screening should be a standard part of an ID consult assessment,” the authors wrote.
“All health care providers have a role in combating the OUD epidemic and its ID consequences. Those who treat infectious complications of OUD are well suited to screen for OUD and begin treatment with effective FDA-approved medications,” the authors concluded.
The workshop was held in March 2018 in Washington and videos and slide presentations from the meeting are available.
Dr. Springer and her colleagues reported grant funding from the National Institutes of Health, but no commercial conflicts.
SOURCE: Springer SA et al. Ann Intern Med. 2018 Jul 13. doi: 10.7326/M18-1203.
Widespread opioid use disorder (OUD) has spawned new epidemics of hepatitis C virus (HCV) and HIV infections as well as increased hospitalizations for bacteremia, endocarditis, skin and soft tissue infections, and osteomyelitis, according to a report arising from a National Academies of Science, Engineering and Medicine (NASEM) workshop titled Integrating Infectious Disease Considerations with Response to the Opioid Epidemic.
Optimal treatment of these infections is often impeded by untreated OUD, Sandra A. Springer, MD, and her colleagues wrote in an article published online in the Annals of Internal Medicine. Failing to address OUD can result in longer hospital stays; frequent readmissions because of a lack of adherence to antibiotic regimens; or reinfection, morbidity, and high costs. “Medical settings that manage such infections offer a potential means of engaging people in treatment of OUD; however, few providers and hospitals treating such infections have the needed resources and capabilities,” Dr. Springer, director, infectious disease outpatient clinic, Veterans Administration, Newington, and of Yale University, New Haven, both in Conn., and her colleagues wrote.
The authors outlined five action steps resulting from the NASEM workshop:
- Implement screening for OUD in all relevant health care settings.
- For patients with positive screening results, immediately prescribe effective medication for OUD and/or opioid withdrawal symptoms.
- Develop hospital-based protocols that facilitate OUD treatment initiation and linkage to community-based treatment upon discharge.
- Hospitals, medical schools, physician assistant schools, nursing schools, and residency programs should increase training to identify and treat OUD.
- Increase access to addiction care and funding to states to provide effective medications to treat OUD.
Opioid withdrawal and pain syndromes should be addressed with opioid agonist therapies to optimize infectious disease (ID) treatment and relieve pain, according to Dr. Springer and her colleagues. In addition, “Because ID specialists are likely to be consulted for anyone requiring long-term antibiotic therapy or patients with HIV and HCV infection, OUD screening should be a standard part of an ID consult assessment,” the authors wrote.
“All health care providers have a role in combating the OUD epidemic and its ID consequences. Those who treat infectious complications of OUD are well suited to screen for OUD and begin treatment with effective FDA-approved medications,” the authors concluded.
The workshop was held in March 2018 in Washington and videos and slide presentations from the meeting are available.
Dr. Springer and her colleagues reported grant funding from the National Institutes of Health, but no commercial conflicts.
SOURCE: Springer SA et al. Ann Intern Med. 2018 Jul 13. doi: 10.7326/M18-1203.
Widespread opioid use disorder (OUD) has spawned new epidemics of hepatitis C virus (HCV) and HIV infections as well as increased hospitalizations for bacteremia, endocarditis, skin and soft tissue infections, and osteomyelitis, according to a report arising from a National Academies of Science, Engineering and Medicine (NASEM) workshop titled Integrating Infectious Disease Considerations with Response to the Opioid Epidemic.
Optimal treatment of these infections is often impeded by untreated OUD, Sandra A. Springer, MD, and her colleagues wrote in an article published online in the Annals of Internal Medicine. Failing to address OUD can result in longer hospital stays; frequent readmissions because of a lack of adherence to antibiotic regimens; or reinfection, morbidity, and high costs. “Medical settings that manage such infections offer a potential means of engaging people in treatment of OUD; however, few providers and hospitals treating such infections have the needed resources and capabilities,” Dr. Springer, director, infectious disease outpatient clinic, Veterans Administration, Newington, and of Yale University, New Haven, both in Conn., and her colleagues wrote.
The authors outlined five action steps resulting from the NASEM workshop:
- Implement screening for OUD in all relevant health care settings.
- For patients with positive screening results, immediately prescribe effective medication for OUD and/or opioid withdrawal symptoms.
- Develop hospital-based protocols that facilitate OUD treatment initiation and linkage to community-based treatment upon discharge.
- Hospitals, medical schools, physician assistant schools, nursing schools, and residency programs should increase training to identify and treat OUD.
- Increase access to addiction care and funding to states to provide effective medications to treat OUD.
Opioid withdrawal and pain syndromes should be addressed with opioid agonist therapies to optimize infectious disease (ID) treatment and relieve pain, according to Dr. Springer and her colleagues. In addition, “Because ID specialists are likely to be consulted for anyone requiring long-term antibiotic therapy or patients with HIV and HCV infection, OUD screening should be a standard part of an ID consult assessment,” the authors wrote.
“All health care providers have a role in combating the OUD epidemic and its ID consequences. Those who treat infectious complications of OUD are well suited to screen for OUD and begin treatment with effective FDA-approved medications,” the authors concluded.
The workshop was held in March 2018 in Washington and videos and slide presentations from the meeting are available.
Dr. Springer and her colleagues reported grant funding from the National Institutes of Health, but no commercial conflicts.
SOURCE: Springer SA et al. Ann Intern Med. 2018 Jul 13. doi: 10.7326/M18-1203.
FROM ANNALS OF INTERNAL MEDICINE
HM18: ‘Things we do for no reason’
Be aware of low value care practices
Presenter
Leonard Feldman, MD, SFHM
Session summary
In the current climate of increasing national health care expenditures, the Journal of Hospital Medicine continues to expand its series “Things We Do for No Reason” to shed light on areas for improvement in the delivery of high-value care. Physicians, however, continue to practice low value care because of practice habits and lack of cost transparency. In keeping with the spirit of the journal’s series, three low-value practices were highlighted in this HM18 session, including the benefits of high-flow nasal cannula (HFNC) oxygen therapy, the value of serum albumin and prealbumin in malnutrition, and the use of nebulized versus inhaler albuterol.
HFNC oxygen therapy has become a widespread practice internationally, with large variations in implementation across all age ranges. In bronchiolitic infants, variations in time of implementation, duration of therapy, weaning policies, and outcome measures have yielded mixed results to date. Many studies are still underway, but current literature has not shown significant benefits of starting HFNC early in the illness process, and infants receiving HFNC have not had better outcomes than those who received standard therapy (low-flow nasal cannula).
Serum albumin and prealbumin are often cited as markers of malnutrition. In patients on tube feeds, such as those with cerebral palsy and complex medical conditions, current literature shows no benefit in the use of these lab markers for screening or for following to assess improvement. In addition, patients with eating disorders do not have significant correlation of their nutritive status with these markers. Therefore, the use of these labs for screening of malnutrition is of little if any value.
Finally, when comparing albuterol delivery systems, there has been no proof that nebulized albuterol is any better than metered dose inhalers (MDI) in its effect. As long as appropriate dosing of MDIs is done, the benefits are the same. In addition, side effects are fewer, and the length of stay in the ED is shorter. The more a family uses MDI inhalers, the better their technique. Studies have shown it takes approximately three attempts at using an MDI to get the technique correct, so inpatient MDI use would also decrease user error in the outpatient setting.
Key takeaways for HM
- Practice habits, lack of transparency of costs, and regional training lead to low value care practices.
- Early introduction of high-flow nasal cannula in hospitalization of an infant with bronchiolitis has not been shown to decrease length of stay or severity outcomes, according to currently available data.
- Serum albumin and prealbumin have little to no benefit in screening of malnutrition.
- Nebulized albuterol has not been proven to be more beneficial that MDI albuterol at appropriate doses.
- Repeat MDI administration has been shown to positively affect user administration techniques.
- MDI albuterol use has fewer side effects and decreased ED length of stay, compared with nebulized albuterol.
Dr. Schwenk is an associate professor of pediatrics at the University of Louisville (Ky.) and a pediatric hospitalist at Norton Children’s Hospital, Louisville.
Be aware of low value care practices
Be aware of low value care practices
Presenter
Leonard Feldman, MD, SFHM
Session summary
In the current climate of increasing national health care expenditures, the Journal of Hospital Medicine continues to expand its series “Things We Do for No Reason” to shed light on areas for improvement in the delivery of high-value care. Physicians, however, continue to practice low value care because of practice habits and lack of cost transparency. In keeping with the spirit of the journal’s series, three low-value practices were highlighted in this HM18 session, including the benefits of high-flow nasal cannula (HFNC) oxygen therapy, the value of serum albumin and prealbumin in malnutrition, and the use of nebulized versus inhaler albuterol.
HFNC oxygen therapy has become a widespread practice internationally, with large variations in implementation across all age ranges. In bronchiolitic infants, variations in time of implementation, duration of therapy, weaning policies, and outcome measures have yielded mixed results to date. Many studies are still underway, but current literature has not shown significant benefits of starting HFNC early in the illness process, and infants receiving HFNC have not had better outcomes than those who received standard therapy (low-flow nasal cannula).
Serum albumin and prealbumin are often cited as markers of malnutrition. In patients on tube feeds, such as those with cerebral palsy and complex medical conditions, current literature shows no benefit in the use of these lab markers for screening or for following to assess improvement. In addition, patients with eating disorders do not have significant correlation of their nutritive status with these markers. Therefore, the use of these labs for screening of malnutrition is of little if any value.
Finally, when comparing albuterol delivery systems, there has been no proof that nebulized albuterol is any better than metered dose inhalers (MDI) in its effect. As long as appropriate dosing of MDIs is done, the benefits are the same. In addition, side effects are fewer, and the length of stay in the ED is shorter. The more a family uses MDI inhalers, the better their technique. Studies have shown it takes approximately three attempts at using an MDI to get the technique correct, so inpatient MDI use would also decrease user error in the outpatient setting.
Key takeaways for HM
- Practice habits, lack of transparency of costs, and regional training lead to low value care practices.
- Early introduction of high-flow nasal cannula in hospitalization of an infant with bronchiolitis has not been shown to decrease length of stay or severity outcomes, according to currently available data.
- Serum albumin and prealbumin have little to no benefit in screening of malnutrition.
- Nebulized albuterol has not been proven to be more beneficial that MDI albuterol at appropriate doses.
- Repeat MDI administration has been shown to positively affect user administration techniques.
- MDI albuterol use has fewer side effects and decreased ED length of stay, compared with nebulized albuterol.
Dr. Schwenk is an associate professor of pediatrics at the University of Louisville (Ky.) and a pediatric hospitalist at Norton Children’s Hospital, Louisville.
Presenter
Leonard Feldman, MD, SFHM
Session summary
In the current climate of increasing national health care expenditures, the Journal of Hospital Medicine continues to expand its series “Things We Do for No Reason” to shed light on areas for improvement in the delivery of high-value care. Physicians, however, continue to practice low value care because of practice habits and lack of cost transparency. In keeping with the spirit of the journal’s series, three low-value practices were highlighted in this HM18 session, including the benefits of high-flow nasal cannula (HFNC) oxygen therapy, the value of serum albumin and prealbumin in malnutrition, and the use of nebulized versus inhaler albuterol.
HFNC oxygen therapy has become a widespread practice internationally, with large variations in implementation across all age ranges. In bronchiolitic infants, variations in time of implementation, duration of therapy, weaning policies, and outcome measures have yielded mixed results to date. Many studies are still underway, but current literature has not shown significant benefits of starting HFNC early in the illness process, and infants receiving HFNC have not had better outcomes than those who received standard therapy (low-flow nasal cannula).
Serum albumin and prealbumin are often cited as markers of malnutrition. In patients on tube feeds, such as those with cerebral palsy and complex medical conditions, current literature shows no benefit in the use of these lab markers for screening or for following to assess improvement. In addition, patients with eating disorders do not have significant correlation of their nutritive status with these markers. Therefore, the use of these labs for screening of malnutrition is of little if any value.
Finally, when comparing albuterol delivery systems, there has been no proof that nebulized albuterol is any better than metered dose inhalers (MDI) in its effect. As long as appropriate dosing of MDIs is done, the benefits are the same. In addition, side effects are fewer, and the length of stay in the ED is shorter. The more a family uses MDI inhalers, the better their technique. Studies have shown it takes approximately three attempts at using an MDI to get the technique correct, so inpatient MDI use would also decrease user error in the outpatient setting.
Key takeaways for HM
- Practice habits, lack of transparency of costs, and regional training lead to low value care practices.
- Early introduction of high-flow nasal cannula in hospitalization of an infant with bronchiolitis has not been shown to decrease length of stay or severity outcomes, according to currently available data.
- Serum albumin and prealbumin have little to no benefit in screening of malnutrition.
- Nebulized albuterol has not been proven to be more beneficial that MDI albuterol at appropriate doses.
- Repeat MDI administration has been shown to positively affect user administration techniques.
- MDI albuterol use has fewer side effects and decreased ED length of stay, compared with nebulized albuterol.
Dr. Schwenk is an associate professor of pediatrics at the University of Louisville (Ky.) and a pediatric hospitalist at Norton Children’s Hospital, Louisville.
Hospitalist movers and shakers – July 2018
Steven Pantilat, MD, MHM, has been named the first chief of the newly established division of palliative medicine at University of California, San Francisco Health. Dr. Pantilat’s new role commenced on May 1st, with the division launch anticipated for July 1st.
Dr. Pantilat is a Master of the Society of Hospital Medicine and a former president of the society (2005-2006).
Gary J. Carver, MD, recently was named the chief medical officer at Coshocton (Ohio) Regional Medical Center. Dr. Carver has been the hospital’s director of hospital medicine since 2013 and will continue in that role in addition to his duties as CMO.
In his new position, Dr. Carver joins Coshocton Medical Center’s senior leadership team, providing medical oversight, as well as clinical direction and leadership as the facility seeks accreditation, quality improvement, and service line development.
Lisa Shah, MD, has been hired by Sound Physicians as the group’s chief innovation officer. Dr. Shah had been working as senior vice president of Evolent Health’s clinical operations and network. With Sound Physicians, Dr. Shah will lead clinical innovation and transformation for the nationwide organization of physicians providing emergency medical, critical care, and hospital medicine services at more than 180 hospitals.
Dr. Shah will be tasked with developing innovative care models, tech-centered clinical workflows, and telemedicine strategies. She brings a robust hospital medicine background, having served in a 2-year Hospitalist Scholars Fellowship at the University of Chicago, while simultaneously earning a master’s degree in public health.
BUSINESS MOVES
The University of Mississippi Medical Center Children’s of Mississippi, Hattiesburg, branch is joining forces with Memorial Hospital at Gulfport (Miss.) to provide care throughout southern Mississippi.
The highlight of the merger is the acquisition of six pediatric clinics into the UMMC family, with UMMC assuming control of the pediatric hospitalist program at each of the locations. The acquired clinics all have been branded as Children’s of Mississippi as of March 26th.
Sound Physicians’ parent company Fresenius Medical Care, which has held a controlling interest in Sound since 2014, has sold that interest to Germany-based Summit Partners for a reported $2.15 billion. The acquisition is expected to be finalized later this calendar year.
Sound, which reported revenues of approximately $1.5 billion in 2017, is optimistic that it can tap into new markets while under the Summit umbrella.
The Ob Hospitalist Group, Greenville, S.C., the nation’s largest Ob/Gyn hospitalist organization, recently announced the rollout of its CARE (Clinician Assistance, Recovery, and Encourage) program. CARE uses peer support to assist clinicians facing psychological and emotional impacts from adverse Ob events.
CARE peer counseling focuses on confidentiality, empathy, trust, and respect for colleagues suffering from a negative patient-care event. The program is available to more than 600 Ob hospitalist clinicians at more than 120 hospitals nationwide.
Steven Pantilat, MD, MHM, has been named the first chief of the newly established division of palliative medicine at University of California, San Francisco Health. Dr. Pantilat’s new role commenced on May 1st, with the division launch anticipated for July 1st.
Dr. Pantilat is a Master of the Society of Hospital Medicine and a former president of the society (2005-2006).
Gary J. Carver, MD, recently was named the chief medical officer at Coshocton (Ohio) Regional Medical Center. Dr. Carver has been the hospital’s director of hospital medicine since 2013 and will continue in that role in addition to his duties as CMO.
In his new position, Dr. Carver joins Coshocton Medical Center’s senior leadership team, providing medical oversight, as well as clinical direction and leadership as the facility seeks accreditation, quality improvement, and service line development.
Lisa Shah, MD, has been hired by Sound Physicians as the group’s chief innovation officer. Dr. Shah had been working as senior vice president of Evolent Health’s clinical operations and network. With Sound Physicians, Dr. Shah will lead clinical innovation and transformation for the nationwide organization of physicians providing emergency medical, critical care, and hospital medicine services at more than 180 hospitals.
Dr. Shah will be tasked with developing innovative care models, tech-centered clinical workflows, and telemedicine strategies. She brings a robust hospital medicine background, having served in a 2-year Hospitalist Scholars Fellowship at the University of Chicago, while simultaneously earning a master’s degree in public health.
BUSINESS MOVES
The University of Mississippi Medical Center Children’s of Mississippi, Hattiesburg, branch is joining forces with Memorial Hospital at Gulfport (Miss.) to provide care throughout southern Mississippi.
The highlight of the merger is the acquisition of six pediatric clinics into the UMMC family, with UMMC assuming control of the pediatric hospitalist program at each of the locations. The acquired clinics all have been branded as Children’s of Mississippi as of March 26th.
Sound Physicians’ parent company Fresenius Medical Care, which has held a controlling interest in Sound since 2014, has sold that interest to Germany-based Summit Partners for a reported $2.15 billion. The acquisition is expected to be finalized later this calendar year.
Sound, which reported revenues of approximately $1.5 billion in 2017, is optimistic that it can tap into new markets while under the Summit umbrella.
The Ob Hospitalist Group, Greenville, S.C., the nation’s largest Ob/Gyn hospitalist organization, recently announced the rollout of its CARE (Clinician Assistance, Recovery, and Encourage) program. CARE uses peer support to assist clinicians facing psychological and emotional impacts from adverse Ob events.
CARE peer counseling focuses on confidentiality, empathy, trust, and respect for colleagues suffering from a negative patient-care event. The program is available to more than 600 Ob hospitalist clinicians at more than 120 hospitals nationwide.
Steven Pantilat, MD, MHM, has been named the first chief of the newly established division of palliative medicine at University of California, San Francisco Health. Dr. Pantilat’s new role commenced on May 1st, with the division launch anticipated for July 1st.
Dr. Pantilat is a Master of the Society of Hospital Medicine and a former president of the society (2005-2006).
Gary J. Carver, MD, recently was named the chief medical officer at Coshocton (Ohio) Regional Medical Center. Dr. Carver has been the hospital’s director of hospital medicine since 2013 and will continue in that role in addition to his duties as CMO.
In his new position, Dr. Carver joins Coshocton Medical Center’s senior leadership team, providing medical oversight, as well as clinical direction and leadership as the facility seeks accreditation, quality improvement, and service line development.
Lisa Shah, MD, has been hired by Sound Physicians as the group’s chief innovation officer. Dr. Shah had been working as senior vice president of Evolent Health’s clinical operations and network. With Sound Physicians, Dr. Shah will lead clinical innovation and transformation for the nationwide organization of physicians providing emergency medical, critical care, and hospital medicine services at more than 180 hospitals.
Dr. Shah will be tasked with developing innovative care models, tech-centered clinical workflows, and telemedicine strategies. She brings a robust hospital medicine background, having served in a 2-year Hospitalist Scholars Fellowship at the University of Chicago, while simultaneously earning a master’s degree in public health.
BUSINESS MOVES
The University of Mississippi Medical Center Children’s of Mississippi, Hattiesburg, branch is joining forces with Memorial Hospital at Gulfport (Miss.) to provide care throughout southern Mississippi.
The highlight of the merger is the acquisition of six pediatric clinics into the UMMC family, with UMMC assuming control of the pediatric hospitalist program at each of the locations. The acquired clinics all have been branded as Children’s of Mississippi as of March 26th.
Sound Physicians’ parent company Fresenius Medical Care, which has held a controlling interest in Sound since 2014, has sold that interest to Germany-based Summit Partners for a reported $2.15 billion. The acquisition is expected to be finalized later this calendar year.
Sound, which reported revenues of approximately $1.5 billion in 2017, is optimistic that it can tap into new markets while under the Summit umbrella.
The Ob Hospitalist Group, Greenville, S.C., the nation’s largest Ob/Gyn hospitalist organization, recently announced the rollout of its CARE (Clinician Assistance, Recovery, and Encourage) program. CARE uses peer support to assist clinicians facing psychological and emotional impacts from adverse Ob events.
CARE peer counseling focuses on confidentiality, empathy, trust, and respect for colleagues suffering from a negative patient-care event. The program is available to more than 600 Ob hospitalist clinicians at more than 120 hospitals nationwide.
Nearly one-quarter of presurgery patients already using opioids
at a large academic medical center, a cross-sectional observational study has determined.
Prescription or illegal opioid use can have profound implications for surgical outcomes and continued postoperative medication abuse. “Preoperative opioid use was associated with a greater burden of comorbid disease and multiple risk factors for poor recovery. ... Opioid-tolerant patients are at risk for opioid-associated adverse events and are less likely to discontinue opioid-based therapy after their surgery,” wrote Paul E. Hilliard, MD, and a team of researchers at the University of Michigan Health System. Although the question of preoperative opioid use has been examined and the Michigan findings are consistent with earlier estimates of prevalence (Ann Surg. 2017;265[4]:695-701), this study sought a more detailed profile of both the characteristics of these patients and the types of procedures correlated with opioid use.
Patient data were derived primarily from two ongoing institutional registries, the Michigan Genomics Initiative and the Analgesic Outcomes Study. Each of these projects involved recruiting nonemergency surgery patients to participate and self-report on pain and affect issues. Opioid use data were extracted from the preop anesthesia history and from physical examination. A total of 34,186 patients were recruited for this study; 54.2% were women, 89.1% were white, and the mean age was 53.1 years. Overall, 23.1% of these patients were taking opioids of various kinds, mostly by prescription along with nonprescription opioids and illegal drugs of other kinds.
The most common opioids found in this patient sample were hydrocodone bitartrate (59.4%), tramadol hydrochloride (21.2%) and oxycodone hydrochloride (18.5%), although the duration or frequency of use was not determined.
“In our experience, in surveys like this patients are pretty honest. [The data do not] track to their medical record, but was done privately for research. That having been said, I am sure there is significant underreporting,” study coauthor Michael J. Englesbe, MD, FACS, said in an interview. In addition to some nondisclosure by study participants, the exclusion of patients admitted to surgery from the ED could mean that 23.1% is a conservative estimate, he noted.
Patient characteristics included in the study (tobacco use, alcohol use, sleep apnea, pain, life satisfaction, depression, anxiety) were self-reported and validated using tools such as the Brief Pain Inventory, the Fibromyalgia Survey, and the Hospital Anxiety and Depression Scale. Procedural data were derived from patient records and ICD-10 data and rated via the ASA score and Charlson Comorbidity Index.
A multivariate analysis of patient characteristics found that age between 31 and 40, tobacco use, heavy alcohol use, pain score, depression, comorbidities reflected in a higher ASA score, and Charlson Comorbidity Score were all significant risk factors for presurgical opiate use.
Patients who were scheduled for surgical procedures involving lower extremities (adjusted odds ratio 3.61, 95% confidence interval, 2.81-4.64) were at the highest risk for opioid use, followed by pelvis surgery, excluding hip (aOR, 3.09, 95% CI, 1.88-5.08), upper arm or elbow (aOR, 3.07, 95% CI, 2.12-4.45), and spine surgery (aOR, 2.68, 95% CI, 2.15-3.32).
The study also broke out the data by presurgery opioid usage and surgery service. Of patients having spine neurosurgery, 55.1% were already taking opioids, and among those having orthopedic spine surgery, 65.1% were taking opioids. General surgery patients were not among those mostly likely to be using opioids (gastrointestinal surgery, 19.3% and endocrine surgery 14.3%). “Certain surgical services may be more likely to encounter patients with high comorbidities for opioid use, and more targeted opioid education strategies aimed at those services may help to mitigate risk in the postoperative period,” the authors wrote.
“All surgeons should take a preop pain history. They should ask about current pain and previous pain experiences. They should also ask about a history of substance use disorder. This should lead into a discussion of the pain expectations from the procedure. Patients should expect to be in pain, that is normal. Pain-free surgery is rare. If a patient has a complex pain history or takes chronic opioids, the surgeon should consider referring them to anesthesia for formal preop pain management planning and potentially weaning of opioid dose prior to elective surgery,” noted Dr. Englesbe, the Cyrenus G. Darling Sr., MD and Cyrenus G Darling Jr., MD Professor of Surgery, and faculty at the Center for Healthcare Outcomes & Policy, University of Michigan, Ann Arbor.
Surgeons are likely to see patients with a past history of opioid dependence or who are recovering from substance abuse. “Every effort should be made to avoid opioids in these patients. We have developed a Pain Optimization Pathway which facilitates no postoperative opioids for these and other patients. These patients are at high risk to relapse and surgeons must know who these patients are so they can provide optimal care,” Dr. Englesbe added.The limitations of this study as reported by the authors include the single-center design, the nondiverse racial makeup of the sample, and the difficulty of ascertaining the dosing and duration of opioid use, both prescription and illegal.
The investigators reported no disclosures relevant to this study. This study was supported by the National Institute on Drug Abuse, National Institutes of Health, the American College of Surgeons, and other noncommercial sources.
SOURCE: Hilliard PE et al. JAMA Surg. 2018 Jul 11. doi: 10.1001/jamasurg.2018.2102.
at a large academic medical center, a cross-sectional observational study has determined.
Prescription or illegal opioid use can have profound implications for surgical outcomes and continued postoperative medication abuse. “Preoperative opioid use was associated with a greater burden of comorbid disease and multiple risk factors for poor recovery. ... Opioid-tolerant patients are at risk for opioid-associated adverse events and are less likely to discontinue opioid-based therapy after their surgery,” wrote Paul E. Hilliard, MD, and a team of researchers at the University of Michigan Health System. Although the question of preoperative opioid use has been examined and the Michigan findings are consistent with earlier estimates of prevalence (Ann Surg. 2017;265[4]:695-701), this study sought a more detailed profile of both the characteristics of these patients and the types of procedures correlated with opioid use.
Patient data were derived primarily from two ongoing institutional registries, the Michigan Genomics Initiative and the Analgesic Outcomes Study. Each of these projects involved recruiting nonemergency surgery patients to participate and self-report on pain and affect issues. Opioid use data were extracted from the preop anesthesia history and from physical examination. A total of 34,186 patients were recruited for this study; 54.2% were women, 89.1% were white, and the mean age was 53.1 years. Overall, 23.1% of these patients were taking opioids of various kinds, mostly by prescription along with nonprescription opioids and illegal drugs of other kinds.
The most common opioids found in this patient sample were hydrocodone bitartrate (59.4%), tramadol hydrochloride (21.2%) and oxycodone hydrochloride (18.5%), although the duration or frequency of use was not determined.
“In our experience, in surveys like this patients are pretty honest. [The data do not] track to their medical record, but was done privately for research. That having been said, I am sure there is significant underreporting,” study coauthor Michael J. Englesbe, MD, FACS, said in an interview. In addition to some nondisclosure by study participants, the exclusion of patients admitted to surgery from the ED could mean that 23.1% is a conservative estimate, he noted.
Patient characteristics included in the study (tobacco use, alcohol use, sleep apnea, pain, life satisfaction, depression, anxiety) were self-reported and validated using tools such as the Brief Pain Inventory, the Fibromyalgia Survey, and the Hospital Anxiety and Depression Scale. Procedural data were derived from patient records and ICD-10 data and rated via the ASA score and Charlson Comorbidity Index.
A multivariate analysis of patient characteristics found that age between 31 and 40, tobacco use, heavy alcohol use, pain score, depression, comorbidities reflected in a higher ASA score, and Charlson Comorbidity Score were all significant risk factors for presurgical opiate use.
Patients who were scheduled for surgical procedures involving lower extremities (adjusted odds ratio 3.61, 95% confidence interval, 2.81-4.64) were at the highest risk for opioid use, followed by pelvis surgery, excluding hip (aOR, 3.09, 95% CI, 1.88-5.08), upper arm or elbow (aOR, 3.07, 95% CI, 2.12-4.45), and spine surgery (aOR, 2.68, 95% CI, 2.15-3.32).
The study also broke out the data by presurgery opioid usage and surgery service. Of patients having spine neurosurgery, 55.1% were already taking opioids, and among those having orthopedic spine surgery, 65.1% were taking opioids. General surgery patients were not among those mostly likely to be using opioids (gastrointestinal surgery, 19.3% and endocrine surgery 14.3%). “Certain surgical services may be more likely to encounter patients with high comorbidities for opioid use, and more targeted opioid education strategies aimed at those services may help to mitigate risk in the postoperative period,” the authors wrote.
“All surgeons should take a preop pain history. They should ask about current pain and previous pain experiences. They should also ask about a history of substance use disorder. This should lead into a discussion of the pain expectations from the procedure. Patients should expect to be in pain, that is normal. Pain-free surgery is rare. If a patient has a complex pain history or takes chronic opioids, the surgeon should consider referring them to anesthesia for formal preop pain management planning and potentially weaning of opioid dose prior to elective surgery,” noted Dr. Englesbe, the Cyrenus G. Darling Sr., MD and Cyrenus G Darling Jr., MD Professor of Surgery, and faculty at the Center for Healthcare Outcomes & Policy, University of Michigan, Ann Arbor.
Surgeons are likely to see patients with a past history of opioid dependence or who are recovering from substance abuse. “Every effort should be made to avoid opioids in these patients. We have developed a Pain Optimization Pathway which facilitates no postoperative opioids for these and other patients. These patients are at high risk to relapse and surgeons must know who these patients are so they can provide optimal care,” Dr. Englesbe added.The limitations of this study as reported by the authors include the single-center design, the nondiverse racial makeup of the sample, and the difficulty of ascertaining the dosing and duration of opioid use, both prescription and illegal.
The investigators reported no disclosures relevant to this study. This study was supported by the National Institute on Drug Abuse, National Institutes of Health, the American College of Surgeons, and other noncommercial sources.
SOURCE: Hilliard PE et al. JAMA Surg. 2018 Jul 11. doi: 10.1001/jamasurg.2018.2102.
at a large academic medical center, a cross-sectional observational study has determined.
Prescription or illegal opioid use can have profound implications for surgical outcomes and continued postoperative medication abuse. “Preoperative opioid use was associated with a greater burden of comorbid disease and multiple risk factors for poor recovery. ... Opioid-tolerant patients are at risk for opioid-associated adverse events and are less likely to discontinue opioid-based therapy after their surgery,” wrote Paul E. Hilliard, MD, and a team of researchers at the University of Michigan Health System. Although the question of preoperative opioid use has been examined and the Michigan findings are consistent with earlier estimates of prevalence (Ann Surg. 2017;265[4]:695-701), this study sought a more detailed profile of both the characteristics of these patients and the types of procedures correlated with opioid use.
Patient data were derived primarily from two ongoing institutional registries, the Michigan Genomics Initiative and the Analgesic Outcomes Study. Each of these projects involved recruiting nonemergency surgery patients to participate and self-report on pain and affect issues. Opioid use data were extracted from the preop anesthesia history and from physical examination. A total of 34,186 patients were recruited for this study; 54.2% were women, 89.1% were white, and the mean age was 53.1 years. Overall, 23.1% of these patients were taking opioids of various kinds, mostly by prescription along with nonprescription opioids and illegal drugs of other kinds.
The most common opioids found in this patient sample were hydrocodone bitartrate (59.4%), tramadol hydrochloride (21.2%) and oxycodone hydrochloride (18.5%), although the duration or frequency of use was not determined.
“In our experience, in surveys like this patients are pretty honest. [The data do not] track to their medical record, but was done privately for research. That having been said, I am sure there is significant underreporting,” study coauthor Michael J. Englesbe, MD, FACS, said in an interview. In addition to some nondisclosure by study participants, the exclusion of patients admitted to surgery from the ED could mean that 23.1% is a conservative estimate, he noted.
Patient characteristics included in the study (tobacco use, alcohol use, sleep apnea, pain, life satisfaction, depression, anxiety) were self-reported and validated using tools such as the Brief Pain Inventory, the Fibromyalgia Survey, and the Hospital Anxiety and Depression Scale. Procedural data were derived from patient records and ICD-10 data and rated via the ASA score and Charlson Comorbidity Index.
A multivariate analysis of patient characteristics found that age between 31 and 40, tobacco use, heavy alcohol use, pain score, depression, comorbidities reflected in a higher ASA score, and Charlson Comorbidity Score were all significant risk factors for presurgical opiate use.
Patients who were scheduled for surgical procedures involving lower extremities (adjusted odds ratio 3.61, 95% confidence interval, 2.81-4.64) were at the highest risk for opioid use, followed by pelvis surgery, excluding hip (aOR, 3.09, 95% CI, 1.88-5.08), upper arm or elbow (aOR, 3.07, 95% CI, 2.12-4.45), and spine surgery (aOR, 2.68, 95% CI, 2.15-3.32).
The study also broke out the data by presurgery opioid usage and surgery service. Of patients having spine neurosurgery, 55.1% were already taking opioids, and among those having orthopedic spine surgery, 65.1% were taking opioids. General surgery patients were not among those mostly likely to be using opioids (gastrointestinal surgery, 19.3% and endocrine surgery 14.3%). “Certain surgical services may be more likely to encounter patients with high comorbidities for opioid use, and more targeted opioid education strategies aimed at those services may help to mitigate risk in the postoperative period,” the authors wrote.
“All surgeons should take a preop pain history. They should ask about current pain and previous pain experiences. They should also ask about a history of substance use disorder. This should lead into a discussion of the pain expectations from the procedure. Patients should expect to be in pain, that is normal. Pain-free surgery is rare. If a patient has a complex pain history or takes chronic opioids, the surgeon should consider referring them to anesthesia for formal preop pain management planning and potentially weaning of opioid dose prior to elective surgery,” noted Dr. Englesbe, the Cyrenus G. Darling Sr., MD and Cyrenus G Darling Jr., MD Professor of Surgery, and faculty at the Center for Healthcare Outcomes & Policy, University of Michigan, Ann Arbor.
Surgeons are likely to see patients with a past history of opioid dependence or who are recovering from substance abuse. “Every effort should be made to avoid opioids in these patients. We have developed a Pain Optimization Pathway which facilitates no postoperative opioids for these and other patients. These patients are at high risk to relapse and surgeons must know who these patients are so they can provide optimal care,” Dr. Englesbe added.The limitations of this study as reported by the authors include the single-center design, the nondiverse racial makeup of the sample, and the difficulty of ascertaining the dosing and duration of opioid use, both prescription and illegal.
The investigators reported no disclosures relevant to this study. This study was supported by the National Institute on Drug Abuse, National Institutes of Health, the American College of Surgeons, and other noncommercial sources.
SOURCE: Hilliard PE et al. JAMA Surg. 2018 Jul 11. doi: 10.1001/jamasurg.2018.2102.
FROM JAMA SURGERY
Key clinical point: Preoperative opioid use is prevalent in patients who are having spinal surgery and have depression.
Major finding:
Study details: An observational study of 34,186 surgical patients in the University of Michigan Health system.
Disclosures: The investigators reported no disclosures relevant to this study. This study was supported by the National Institute on Drug Abuse, National Institutes of Health, the American College of Surgeons, and other noncommercial sources.
Source: Hilliard P E et al. JAMA Surg. 2018 Jul 11;. doi:10.1001/jamasurg.2018.2102.
CMS considers expanding telemedicine payments
Payment for more telemedicine services could be in store for physicians and other health providers if new proposals in the latest fee schedule from the Centers for Medicare & Medicaid Services are finalized.
Under the proposed physician fee schedule, announced July 12, the CMS would expand services that qualify for telemedicine payments and add reimbursement for virtual check-ins by phone or other technologies, such as Skype. Telemedicine clinicians would also be paid for time spent reviewing patient photos sent by text or e-mail under the suggested changes.
Such telehealth services would aid patients who have transportation difficulties by creating more opportunities for them to access personalized care, said CMS Administrator Seema Verma.
“CMS is committed to modernizing the Medicare program by leveraging technologies, such as audio/video applications or patient-facing health portals, that will help beneficiaries access high-quality services in a convenient manner,” Ms. Verma said in a statement.
Under the proposal, physicians could bill separately for brief, non–face-to-face patient check-ins with patients via communication technology beginning January 2019. In addition, the proposed rule carves out payments for the remote professional evaluation of patient-transmitted information conducted via prerecorded “store and forward” video or image technology. Doctors could use both services to determine whether an office visit or other service is warranted, according to the proposed rule.
The services would have limitations on when they could be separately billed. In cases where the brief communication technology–based service originated from a related evaluation and management (E/M) service provided within the previous 7 days by the same physician or other qualified health care professional, the service would be considered “bundled” into that previous E/M service and could not be billed separately. Similarly, a photo evaluation could not be separately billed if it stemmed from a related E/M service provided within the previous 7 days by the same physician, or if the evaluation results in an in-person E/M office visit with the same doctor.
Under the proposal, health providers could perform the newly covered telehealth services only with established patients, but the CMS is seeking comments as to whether in certain cases, such as dermatological or ophthalmological instances, it might be appropriate for a new patient to receive the services. Agency officials also want to know what types of communication technology are used by physicians in furnishing check-in services, including whether audio-only telephone interactions are sufficient, compared with interactions that are enhanced with video. The CMS is asking physicians whether it would be clinically appropriate to apply a frequency limitation on the use of the proposed telehealth services by the same physician.
Latoya Thomas, director of the American Telemedicine Association’s State Policy Resource Center, said the proposal is exciting because it acknowledges the pervasive growth, accessibility, and acceptance of technology advances.
“In expanding reimbursement to providers for more modality-neutral and site-neutral virtual care, such as store-and-forward and remote patient monitoring, [the rules] address longstanding barriers to broader dissemination of telehealth,” Ms. Thomas said in an interview. “By making available ‘virtual check ins’ to every Medicare beneficiary, it can improve patient engagement and reduce unnecessary trips back to their provider’s office.”
James P. Marcin, MD, a telemedicine physician and director of the Center for Health and Technology at UC Davis Children’s Hospital in Sacramento, Calif., said he was pleased with the proposed telehealth changes, but he noted that more work remains to address further telemedicine challenges.
“The needle is finally moving, albeit too slowly for some of us,” Dr. Marcin said in an interview. “There are still some areas users of telemedicine and organizations supporting the use of telemedicine want to address, including the need for verbal informed consent, the requirements for established relationships with patients, and of course, rate valuations for the remote patient monitoring and professional codes. But again, this is good news for patients.”
Public comments on the proposed rule are due by Sept. 10, 2018. Comments can be submitted to regulations.gov.
Payment for more telemedicine services could be in store for physicians and other health providers if new proposals in the latest fee schedule from the Centers for Medicare & Medicaid Services are finalized.
Under the proposed physician fee schedule, announced July 12, the CMS would expand services that qualify for telemedicine payments and add reimbursement for virtual check-ins by phone or other technologies, such as Skype. Telemedicine clinicians would also be paid for time spent reviewing patient photos sent by text or e-mail under the suggested changes.
Such telehealth services would aid patients who have transportation difficulties by creating more opportunities for them to access personalized care, said CMS Administrator Seema Verma.
“CMS is committed to modernizing the Medicare program by leveraging technologies, such as audio/video applications or patient-facing health portals, that will help beneficiaries access high-quality services in a convenient manner,” Ms. Verma said in a statement.
Under the proposal, physicians could bill separately for brief, non–face-to-face patient check-ins with patients via communication technology beginning January 2019. In addition, the proposed rule carves out payments for the remote professional evaluation of patient-transmitted information conducted via prerecorded “store and forward” video or image technology. Doctors could use both services to determine whether an office visit or other service is warranted, according to the proposed rule.
The services would have limitations on when they could be separately billed. In cases where the brief communication technology–based service originated from a related evaluation and management (E/M) service provided within the previous 7 days by the same physician or other qualified health care professional, the service would be considered “bundled” into that previous E/M service and could not be billed separately. Similarly, a photo evaluation could not be separately billed if it stemmed from a related E/M service provided within the previous 7 days by the same physician, or if the evaluation results in an in-person E/M office visit with the same doctor.
Under the proposal, health providers could perform the newly covered telehealth services only with established patients, but the CMS is seeking comments as to whether in certain cases, such as dermatological or ophthalmological instances, it might be appropriate for a new patient to receive the services. Agency officials also want to know what types of communication technology are used by physicians in furnishing check-in services, including whether audio-only telephone interactions are sufficient, compared with interactions that are enhanced with video. The CMS is asking physicians whether it would be clinically appropriate to apply a frequency limitation on the use of the proposed telehealth services by the same physician.
Latoya Thomas, director of the American Telemedicine Association’s State Policy Resource Center, said the proposal is exciting because it acknowledges the pervasive growth, accessibility, and acceptance of technology advances.
“In expanding reimbursement to providers for more modality-neutral and site-neutral virtual care, such as store-and-forward and remote patient monitoring, [the rules] address longstanding barriers to broader dissemination of telehealth,” Ms. Thomas said in an interview. “By making available ‘virtual check ins’ to every Medicare beneficiary, it can improve patient engagement and reduce unnecessary trips back to their provider’s office.”
James P. Marcin, MD, a telemedicine physician and director of the Center for Health and Technology at UC Davis Children’s Hospital in Sacramento, Calif., said he was pleased with the proposed telehealth changes, but he noted that more work remains to address further telemedicine challenges.
“The needle is finally moving, albeit too slowly for some of us,” Dr. Marcin said in an interview. “There are still some areas users of telemedicine and organizations supporting the use of telemedicine want to address, including the need for verbal informed consent, the requirements for established relationships with patients, and of course, rate valuations for the remote patient monitoring and professional codes. But again, this is good news for patients.”
Public comments on the proposed rule are due by Sept. 10, 2018. Comments can be submitted to regulations.gov.
Payment for more telemedicine services could be in store for physicians and other health providers if new proposals in the latest fee schedule from the Centers for Medicare & Medicaid Services are finalized.
Under the proposed physician fee schedule, announced July 12, the CMS would expand services that qualify for telemedicine payments and add reimbursement for virtual check-ins by phone or other technologies, such as Skype. Telemedicine clinicians would also be paid for time spent reviewing patient photos sent by text or e-mail under the suggested changes.
Such telehealth services would aid patients who have transportation difficulties by creating more opportunities for them to access personalized care, said CMS Administrator Seema Verma.
“CMS is committed to modernizing the Medicare program by leveraging technologies, such as audio/video applications or patient-facing health portals, that will help beneficiaries access high-quality services in a convenient manner,” Ms. Verma said in a statement.
Under the proposal, physicians could bill separately for brief, non–face-to-face patient check-ins with patients via communication technology beginning January 2019. In addition, the proposed rule carves out payments for the remote professional evaluation of patient-transmitted information conducted via prerecorded “store and forward” video or image technology. Doctors could use both services to determine whether an office visit or other service is warranted, according to the proposed rule.
The services would have limitations on when they could be separately billed. In cases where the brief communication technology–based service originated from a related evaluation and management (E/M) service provided within the previous 7 days by the same physician or other qualified health care professional, the service would be considered “bundled” into that previous E/M service and could not be billed separately. Similarly, a photo evaluation could not be separately billed if it stemmed from a related E/M service provided within the previous 7 days by the same physician, or if the evaluation results in an in-person E/M office visit with the same doctor.
Under the proposal, health providers could perform the newly covered telehealth services only with established patients, but the CMS is seeking comments as to whether in certain cases, such as dermatological or ophthalmological instances, it might be appropriate for a new patient to receive the services. Agency officials also want to know what types of communication technology are used by physicians in furnishing check-in services, including whether audio-only telephone interactions are sufficient, compared with interactions that are enhanced with video. The CMS is asking physicians whether it would be clinically appropriate to apply a frequency limitation on the use of the proposed telehealth services by the same physician.
Latoya Thomas, director of the American Telemedicine Association’s State Policy Resource Center, said the proposal is exciting because it acknowledges the pervasive growth, accessibility, and acceptance of technology advances.
“In expanding reimbursement to providers for more modality-neutral and site-neutral virtual care, such as store-and-forward and remote patient monitoring, [the rules] address longstanding barriers to broader dissemination of telehealth,” Ms. Thomas said in an interview. “By making available ‘virtual check ins’ to every Medicare beneficiary, it can improve patient engagement and reduce unnecessary trips back to their provider’s office.”
James P. Marcin, MD, a telemedicine physician and director of the Center for Health and Technology at UC Davis Children’s Hospital in Sacramento, Calif., said he was pleased with the proposed telehealth changes, but he noted that more work remains to address further telemedicine challenges.
“The needle is finally moving, albeit too slowly for some of us,” Dr. Marcin said in an interview. “There are still some areas users of telemedicine and organizations supporting the use of telemedicine want to address, including the need for verbal informed consent, the requirements for established relationships with patients, and of course, rate valuations for the remote patient monitoring and professional codes. But again, this is good news for patients.”
Public comments on the proposed rule are due by Sept. 10, 2018. Comments can be submitted to regulations.gov.