Clinical question: Does ciprofloxacin administered once weekly prevent spontaneous bacterial peritonitis (SBP) as effectively as daily norfloxacin?

Background: Studies have shown that daily administration of norfloxacin is effective for primary prophylaxis as well as secondary prevention of SBP in patients with cirrhosis and ascites. Prior studies have demonstrated efficacy of weekly ciprofloxacin, but no previous studies have compared the two antibiotics.

Study design: Investigator initiated open-label randomized, controlled trial.

Setting: Seven tertiary hospitals in South Korea.

Dr. Angeli is an assistant professor in the division of hospital medicine, University of New Mexico.

Clinical question: Does ciprofloxacin administered once weekly prevent spontaneous bacterial peritonitis (SBP) as effectively as daily norfloxacin?

Background: Studies have shown that daily administration of norfloxacin is effective for primary prophylaxis as well as secondary prevention of SBP in patients with cirrhosis and ascites. Prior studies have demonstrated efficacy of weekly ciprofloxacin, but no previous studies have compared the two antibiotics.

Study design: Investigator initiated open-label randomized, controlled trial.

Setting: Seven tertiary hospitals in South Korea.

Dr. Angeli is an assistant professor in the division of hospital medicine, University of New Mexico.

Clinical question: Does ciprofloxacin administered once weekly prevent spontaneous bacterial peritonitis (SBP) as effectively as daily norfloxacin?

Background: Studies have shown that daily administration of norfloxacin is effective for primary prophylaxis as well as secondary prevention of SBP in patients with cirrhosis and ascites. Prior studies have demonstrated efficacy of weekly ciprofloxacin, but no previous studies have compared the two antibiotics.

Study design: Investigator initiated open-label randomized, controlled trial.

Setting: Seven tertiary hospitals in South Korea.

Dr. Angeli is an assistant professor in the division of hospital medicine, University of New Mexico.

To provide better “culturally responsive” care, the IHS and American College of Obstetricians and Gynecologists (ACOG) have announced new clinical recommendations for health care providers (HCPs) who treat Native American pregnant woman and women of childbearing age with opioid use disorder (OUD).

There are no current comprehensive guidelines to manage the care of pregnant women with opioid dependence who live in rural or remote communities, ACOG acknowledges. That absence, in addition to a lack of resources, lack of training in treating substance use disorder in pregnancy, and providers’ discomfort with opioid agonist therapy in pregnancy, has contributed to “wide variation in the quality of care these women receive.”

Disparities are particularly extreme for American Indian and Alaska Native women (AI/AN), ACOG notes. They have the highest risk of dying of prescription opioid overdose, and they face specific barriers to accessing treatment. For instance, there are few opioid treatment programs offering methadone treatment on tribal lands.

The new recommendations were developed in partnership with tribes and ACOG’s Committee on American Indian and Alaska Native Women’s Health, based on critical feedback from listening sessions and tribal consultations in the past year. The specific guidelines are tailored for Native women.

 The committee recognizes, it says, the “necessary wide-ranging scope of treatment for OUD, especially among AI/AN childbearing women.” Key recommendations include strategies to avoid or minimize the use of opioids for pain management and encourage alternative pain therapies, such as physical therapy, acupuncture, and mindfulness-based therapy. In pregnancy, ACOG recommends that obstetric providers perform universal screening and brief intervention using a validated tool as early in prenatal care as possible.

Treatment may require management of co-occurring polysubstance use disorders; concomitant alcohol and methamphetamine use predominate in many tribal areas. HCPs also may need to offer personalized care that “acknowledges the contributions of intergenerational and personal trauma,” the guidelines say. Trauma-informed interdisciplinary approaches to posttraumatic stress disorder that engage tribal resources, social structures, and assets are “crucial to impactful care of opioid use disorder.”

The postpartum period is associated with a high rate of relapse, ACOG says. Histories of trauma, for instance, can exacerbate mood disorders. Moreover, substance use and overdose are increasingly being recognized as key contributors to pregnancy-associated death in the US; a disproportionate share of deaths are postpartum. Infants of untreated, depressed mothers demonstrate poor outcomes, including impaired motor adaptation and self-regulation, developmental delay, and higher arousal scores. The guidelines advise treating mothers and infants as dyads to improve the course of neonatal opioid withdrawal syndrome (NOWS). The proportion of infants with NOWS who need pharmacologic treatment has risen dramatically, the committee notes.

 “[I]t is clear from our site visits and clinical experience,” the committee members note, “that adaptation of systems for integration and reach in rural settings is necessary, with potentially different needs and assets in Native and rural populations.” Native culture and traditions, they add, offer opportunities for community engagement and support that can be integrated into medical care for the women and their infants.

To provide better “culturally responsive” care, the IHS and American College of Obstetricians and Gynecologists (ACOG) have announced new clinical recommendations for health care providers (HCPs) who treat Native American pregnant woman and women of childbearing age with opioid use disorder (OUD).

There are no current comprehensive guidelines to manage the care of pregnant women with opioid dependence who live in rural or remote communities, ACOG acknowledges. That absence, in addition to a lack of resources, lack of training in treating substance use disorder in pregnancy, and providers’ discomfort with opioid agonist therapy in pregnancy, has contributed to “wide variation in the quality of care these women receive.”

Disparities are particularly extreme for American Indian and Alaska Native women (AI/AN), ACOG notes. They have the highest risk of dying of prescription opioid overdose, and they face specific barriers to accessing treatment. For instance, there are few opioid treatment programs offering methadone treatment on tribal lands.

The new recommendations were developed in partnership with tribes and ACOG’s Committee on American Indian and Alaska Native Women’s Health, based on critical feedback from listening sessions and tribal consultations in the past year. The specific guidelines are tailored for Native women.

 The committee recognizes, it says, the “necessary wide-ranging scope of treatment for OUD, especially among AI/AN childbearing women.” Key recommendations include strategies to avoid or minimize the use of opioids for pain management and encourage alternative pain therapies, such as physical therapy, acupuncture, and mindfulness-based therapy. In pregnancy, ACOG recommends that obstetric providers perform universal screening and brief intervention using a validated tool as early in prenatal care as possible.

Treatment may require management of co-occurring polysubstance use disorders; concomitant alcohol and methamphetamine use predominate in many tribal areas. HCPs also may need to offer personalized care that “acknowledges the contributions of intergenerational and personal trauma,” the guidelines say. Trauma-informed interdisciplinary approaches to posttraumatic stress disorder that engage tribal resources, social structures, and assets are “crucial to impactful care of opioid use disorder.”

The postpartum period is associated with a high rate of relapse, ACOG says. Histories of trauma, for instance, can exacerbate mood disorders. Moreover, substance use and overdose are increasingly being recognized as key contributors to pregnancy-associated death in the US; a disproportionate share of deaths are postpartum. Infants of untreated, depressed mothers demonstrate poor outcomes, including impaired motor adaptation and self-regulation, developmental delay, and higher arousal scores. The guidelines advise treating mothers and infants as dyads to improve the course of neonatal opioid withdrawal syndrome (NOWS). The proportion of infants with NOWS who need pharmacologic treatment has risen dramatically, the committee notes.

 “[I]t is clear from our site visits and clinical experience,” the committee members note, “that adaptation of systems for integration and reach in rural settings is necessary, with potentially different needs and assets in Native and rural populations.” Native culture and traditions, they add, offer opportunities for community engagement and support that can be integrated into medical care for the women and their infants.

To provide better “culturally responsive” care, the IHS and American College of Obstetricians and Gynecologists (ACOG) have announced new clinical recommendations for health care providers (HCPs) who treat Native American pregnant woman and women of childbearing age with opioid use disorder (OUD).

There are no current comprehensive guidelines to manage the care of pregnant women with opioid dependence who live in rural or remote communities, ACOG acknowledges. That absence, in addition to a lack of resources, lack of training in treating substance use disorder in pregnancy, and providers’ discomfort with opioid agonist therapy in pregnancy, has contributed to “wide variation in the quality of care these women receive.”

Disparities are particularly extreme for American Indian and Alaska Native women (AI/AN), ACOG notes. They have the highest risk of dying of prescription opioid overdose, and they face specific barriers to accessing treatment. For instance, there are few opioid treatment programs offering methadone treatment on tribal lands.

The new recommendations were developed in partnership with tribes and ACOG’s Committee on American Indian and Alaska Native Women’s Health, based on critical feedback from listening sessions and tribal consultations in the past year. The specific guidelines are tailored for Native women.

 The committee recognizes, it says, the “necessary wide-ranging scope of treatment for OUD, especially among AI/AN childbearing women.” Key recommendations include strategies to avoid or minimize the use of opioids for pain management and encourage alternative pain therapies, such as physical therapy, acupuncture, and mindfulness-based therapy. In pregnancy, ACOG recommends that obstetric providers perform universal screening and brief intervention using a validated tool as early in prenatal care as possible.

Treatment may require management of co-occurring polysubstance use disorders; concomitant alcohol and methamphetamine use predominate in many tribal areas. HCPs also may need to offer personalized care that “acknowledges the contributions of intergenerational and personal trauma,” the guidelines say. Trauma-informed interdisciplinary approaches to posttraumatic stress disorder that engage tribal resources, social structures, and assets are “crucial to impactful care of opioid use disorder.”

The postpartum period is associated with a high rate of relapse, ACOG says. Histories of trauma, for instance, can exacerbate mood disorders. Moreover, substance use and overdose are increasingly being recognized as key contributors to pregnancy-associated death in the US; a disproportionate share of deaths are postpartum. Infants of untreated, depressed mothers demonstrate poor outcomes, including impaired motor adaptation and self-regulation, developmental delay, and higher arousal scores. The guidelines advise treating mothers and infants as dyads to improve the course of neonatal opioid withdrawal syndrome (NOWS). The proportion of infants with NOWS who need pharmacologic treatment has risen dramatically, the committee notes.

 “[I]t is clear from our site visits and clinical experience,” the committee members note, “that adaptation of systems for integration and reach in rural settings is necessary, with potentially different needs and assets in Native and rural populations.” Native culture and traditions, they add, offer opportunities for community engagement and support that can be integrated into medical care for the women and their infants.

NASHVILLE, TENN. – Biopsy isn’t usually the first step in evaluating the endometrium of a reproductive-age woman who presents with abnormal uterine bleeding, but that’s not always the case, according to James M. Shwayder, MD.

Vidyard Video

“If we have young women come in, generally speaking, we don’t think much about doing biopsies, but there are those patients who really require a biopsy very early on: If they are obese and if they have long histories of oligomenorrhea ... they are at significantly greater risk for either endometrial hyperplasia or cancer, so in those patients I recommend biopsy very early on,” Dr. Shwayder said in this video interview about his presentation entitled “Modern Evaluation of the Endometrium: When to Use Ultrasound, When to Biopsy,” as presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Conversely, in some cases when biopsy is typically considered the first-line step in evaluation, ultrasound may actually be better, he argued.

“[ACOG] recommends that women over 45 ... should have a biopsy done as their first-line evaluation. I kind of take issue with that a little bit,” said Dr. Shwayder, a professor at the University of Mississippi Medical Center, Jackson, and president and chief executive officer of Shwayder Consulting in Venice, Fla.

Data suggest that a “blind biopsy” could miss up to 18% of cases involving either a submucous myoma or a polyp and that one-third to one-fourth of patients have a structural defect such as a polyp or fibroid that can’t be diagnosed with a biopsy, he explained, noting that sonohysterography is best for preoperative evaluation in such case.

Ultrasound also has utility for evaluating other abnormalities, and it can be a very simple way to evaluate the patient and decide whether they need further evaluation or further treatment, he said.

Dr. Shwayder also discussed evidence for making a choice between biopsy and ultrasound for initial evaluation in postmenopausal women and for assessing women with asymptomatic thickened endometrium.

Dr. Shwayder is a consultant for GE Ultrasound.

[email protected]

NASHVILLE, TENN. – Biopsy isn’t usually the first step in evaluating the endometrium of a reproductive-age woman who presents with abnormal uterine bleeding, but that’s not always the case, according to James M. Shwayder, MD.

Vidyard Video

“If we have young women come in, generally speaking, we don’t think much about doing biopsies, but there are those patients who really require a biopsy very early on: If they are obese and if they have long histories of oligomenorrhea ... they are at significantly greater risk for either endometrial hyperplasia or cancer, so in those patients I recommend biopsy very early on,” Dr. Shwayder said in this video interview about his presentation entitled “Modern Evaluation of the Endometrium: When to Use Ultrasound, When to Biopsy,” as presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Conversely, in some cases when biopsy is typically considered the first-line step in evaluation, ultrasound may actually be better, he argued.

“[ACOG] recommends that women over 45 ... should have a biopsy done as their first-line evaluation. I kind of take issue with that a little bit,” said Dr. Shwayder, a professor at the University of Mississippi Medical Center, Jackson, and president and chief executive officer of Shwayder Consulting in Venice, Fla.

Data suggest that a “blind biopsy” could miss up to 18% of cases involving either a submucous myoma or a polyp and that one-third to one-fourth of patients have a structural defect such as a polyp or fibroid that can’t be diagnosed with a biopsy, he explained, noting that sonohysterography is best for preoperative evaluation in such case.

Ultrasound also has utility for evaluating other abnormalities, and it can be a very simple way to evaluate the patient and decide whether they need further evaluation or further treatment, he said.

Dr. Shwayder also discussed evidence for making a choice between biopsy and ultrasound for initial evaluation in postmenopausal women and for assessing women with asymptomatic thickened endometrium.

Dr. Shwayder is a consultant for GE Ultrasound.

[email protected]

NASHVILLE, TENN. – Biopsy isn’t usually the first step in evaluating the endometrium of a reproductive-age woman who presents with abnormal uterine bleeding, but that’s not always the case, according to James M. Shwayder, MD.

Vidyard Video

“If we have young women come in, generally speaking, we don’t think much about doing biopsies, but there are those patients who really require a biopsy very early on: If they are obese and if they have long histories of oligomenorrhea ... they are at significantly greater risk for either endometrial hyperplasia or cancer, so in those patients I recommend biopsy very early on,” Dr. Shwayder said in this video interview about his presentation entitled “Modern Evaluation of the Endometrium: When to Use Ultrasound, When to Biopsy,” as presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Conversely, in some cases when biopsy is typically considered the first-line step in evaluation, ultrasound may actually be better, he argued.

“[ACOG] recommends that women over 45 ... should have a biopsy done as their first-line evaluation. I kind of take issue with that a little bit,” said Dr. Shwayder, a professor at the University of Mississippi Medical Center, Jackson, and president and chief executive officer of Shwayder Consulting in Venice, Fla.

Data suggest that a “blind biopsy” could miss up to 18% of cases involving either a submucous myoma or a polyp and that one-third to one-fourth of patients have a structural defect such as a polyp or fibroid that can’t be diagnosed with a biopsy, he explained, noting that sonohysterography is best for preoperative evaluation in such case.

Ultrasound also has utility for evaluating other abnormalities, and it can be a very simple way to evaluate the patient and decide whether they need further evaluation or further treatment, he said.

Dr. Shwayder also discussed evidence for making a choice between biopsy and ultrasound for initial evaluation in postmenopausal women and for assessing women with asymptomatic thickened endometrium.

Dr. Shwayder is a consultant for GE Ultrasound.

[email protected]

NASHVILLE, TENN. – Immediate postpartum insertion of an intrauterine device (IUD) is highly cost effective despite an expulsion rate of 10%-30%, according to Eve Espey, MD.

“I think [the rate] is going to settle out at around 15%-20%, but good cost-effectiveness studies show that, even if it were that high, it is still highly cost effective,” she said during an update on contraceptives at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Immediate postpartum long-acting reversible contraception (LARC), including an IUD or implant, may reduce rapid-repeat pregnancy, she added, noting, however, that while Medicaid is covering it in many states, “it turns out that payment models are very cumbersome; they actually don’t work very well.”

At the University of New Mexico (UNM) in Albuquerque, where Dr .Espey is a professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship, immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases.

It took about 4 years of persistent effort to make that happen, she said, adding that the UNM Hospital still is the only one in the state offering the service, although efforts are underway to help other hospitals “troubleshoot the issues.”

Another challenge is the lack of private insurance coverage for immediate postpartum LARC, she said.

“I was super enthusiastic about this a few years ago, and I remain super enthusiastic about it, but I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen.”

In this video interview, Dr. Espey discusses the “agony and ecstasy” of immediate postpartum LARC, summarizing the main points regarding its benefits and challenges as presented during an “EdTalk” she gave at the meeting.

Dr. Espey reported having no relevant financial disclosures.

[email protected]

NASHVILLE, TENN. – Immediate postpartum insertion of an intrauterine device (IUD) is highly cost effective despite an expulsion rate of 10%-30%, according to Eve Espey, MD.

“I think [the rate] is going to settle out at around 15%-20%, but good cost-effectiveness studies show that, even if it were that high, it is still highly cost effective,” she said during an update on contraceptives at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Immediate postpartum long-acting reversible contraception (LARC), including an IUD or implant, may reduce rapid-repeat pregnancy, she added, noting, however, that while Medicaid is covering it in many states, “it turns out that payment models are very cumbersome; they actually don’t work very well.”

At the University of New Mexico (UNM) in Albuquerque, where Dr .Espey is a professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship, immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases.

It took about 4 years of persistent effort to make that happen, she said, adding that the UNM Hospital still is the only one in the state offering the service, although efforts are underway to help other hospitals “troubleshoot the issues.”

Another challenge is the lack of private insurance coverage for immediate postpartum LARC, she said.

“I was super enthusiastic about this a few years ago, and I remain super enthusiastic about it, but I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen.”

In this video interview, Dr. Espey discusses the “agony and ecstasy” of immediate postpartum LARC, summarizing the main points regarding its benefits and challenges as presented during an “EdTalk” she gave at the meeting.

Dr. Espey reported having no relevant financial disclosures.

[email protected]

NASHVILLE, TENN. – Immediate postpartum insertion of an intrauterine device (IUD) is highly cost effective despite an expulsion rate of 10%-30%, according to Eve Espey, MD.

“I think [the rate] is going to settle out at around 15%-20%, but good cost-effectiveness studies show that, even if it were that high, it is still highly cost effective,” she said during an update on contraceptives at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Immediate postpartum long-acting reversible contraception (LARC), including an IUD or implant, may reduce rapid-repeat pregnancy, she added, noting, however, that while Medicaid is covering it in many states, “it turns out that payment models are very cumbersome; they actually don’t work very well.”

At the University of New Mexico (UNM) in Albuquerque, where Dr .Espey is a professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship, immediate postpartum LARC is offered to women with Medicaid coverage, and payment is received in about 97% of cases.

It took about 4 years of persistent effort to make that happen, she said, adding that the UNM Hospital still is the only one in the state offering the service, although efforts are underway to help other hospitals “troubleshoot the issues.”

Another challenge is the lack of private insurance coverage for immediate postpartum LARC, she said.

“I was super enthusiastic about this a few years ago, and I remain super enthusiastic about it, but I think it’s going to take another 5 years or so [for better coverage], and honestly I think what we really need is an inpatient LARC CPT code to make this happen.”

In this video interview, Dr. Espey discusses the “agony and ecstasy” of immediate postpartum LARC, summarizing the main points regarding its benefits and challenges as presented during an “EdTalk” she gave at the meeting.

Dr. Espey reported having no relevant financial disclosures.

[email protected]

Background: Most large studies of magnesium sulfate for assistance with rate control in AF occurred in the postoperative setting. This study compared rate control in the ED using magnesium sulfate at high (9 g) and low (4.5 g) doses vs. placebo in combination with usual treatment with atrioventricular nodal-blocking agents.

Rate control was achieved at 4 hours in 64% of patients with low-dose magnesium, 59% with high-dose magnesium, and 43% with placebo. At 24 hours, reduction in rate was controlled for 97% of patients on the low dose, 94% on the high dose, and 83% on placebo. Adverse events were mostly flushing, which occurred more frequently with the high dose than the low dose. Major limitations of the study included a lack of statistical assessment regarding baseline similarity between the two groups and that generalizability was limited by a preference for digoxin as the AV nodal agent.

Bottom line: This trial demonstrated that 4.5 g of magnesium sulfate was a useful addition to AV nodal blockers in achieving faster rate control for atrial fibrillation with rapid ventricular response in selected ED patients.

Citation: Bouida W et al. Low-dose magnesium sulfate versus high dose in the early management of rapid atrial fibrillation: Randomized controlled double blind study. Acad Emerg Med. 2018 Jul 19. doi: 10.1111/acem.13522.

Dr. Scott is an assistant professor in the division of hospital medicine, University of New Mexico.

Background: Most large studies of magnesium sulfate for assistance with rate control in AF occurred in the postoperative setting. This study compared rate control in the ED using magnesium sulfate at high (9 g) and low (4.5 g) doses vs. placebo in combination with usual treatment with atrioventricular nodal-blocking agents.

Rate control was achieved at 4 hours in 64% of patients with low-dose magnesium, 59% with high-dose magnesium, and 43% with placebo. At 24 hours, reduction in rate was controlled for 97% of patients on the low dose, 94% on the high dose, and 83% on placebo. Adverse events were mostly flushing, which occurred more frequently with the high dose than the low dose. Major limitations of the study included a lack of statistical assessment regarding baseline similarity between the two groups and that generalizability was limited by a preference for digoxin as the AV nodal agent.

Bottom line: This trial demonstrated that 4.5 g of magnesium sulfate was a useful addition to AV nodal blockers in achieving faster rate control for atrial fibrillation with rapid ventricular response in selected ED patients.

Citation: Bouida W et al. Low-dose magnesium sulfate versus high dose in the early management of rapid atrial fibrillation: Randomized controlled double blind study. Acad Emerg Med. 2018 Jul 19. doi: 10.1111/acem.13522.

Dr. Scott is an assistant professor in the division of hospital medicine, University of New Mexico.

Background: Most large studies of magnesium sulfate for assistance with rate control in AF occurred in the postoperative setting. This study compared rate control in the ED using magnesium sulfate at high (9 g) and low (4.5 g) doses vs. placebo in combination with usual treatment with atrioventricular nodal-blocking agents.

Rate control was achieved at 4 hours in 64% of patients with low-dose magnesium, 59% with high-dose magnesium, and 43% with placebo. At 24 hours, reduction in rate was controlled for 97% of patients on the low dose, 94% on the high dose, and 83% on placebo. Adverse events were mostly flushing, which occurred more frequently with the high dose than the low dose. Major limitations of the study included a lack of statistical assessment regarding baseline similarity between the two groups and that generalizability was limited by a preference for digoxin as the AV nodal agent.

Bottom line: This trial demonstrated that 4.5 g of magnesium sulfate was a useful addition to AV nodal blockers in achieving faster rate control for atrial fibrillation with rapid ventricular response in selected ED patients.

Citation: Bouida W et al. Low-dose magnesium sulfate versus high dose in the early management of rapid atrial fibrillation: Randomized controlled double blind study. Acad Emerg Med. 2018 Jul 19. doi: 10.1111/acem.13522.

Dr. Scott is an assistant professor in the division of hospital medicine, University of New Mexico.

Lenalidomide can reduce the risk of progression from smoldering multiple myeloma (SMM) to multiple myeloma (MM), according to a phase 2/3 trial.

At 3 years, the rate of progression-free survival (PFS) was 91% in SMM patients randomized to lenalidomide and 66% in those randomized to observation.

However, more than half of patients randomized to lenalidomide discontinued treatment because of toxicity.

These results are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.

Sagar Lonial, MD, of Winship Cancer Institute, Emory University, Atlanta, discussed the results in a press briefing in advance of the meeting.

A prior trial suggested that lenalidomide plus dexamethasone can improve time to MM development and overall survival in patients with high-risk SMM (Mateos MV et al. NEJM 2013). However, inferior imaging was used in this trial, and the addition of dexamethasone hindered researchers’ ability to isolate the effects of lenalidomide, Dr. Lonial said.

With their trial (NCT01169337), Dr. Lonial and colleagues tested lenalidomide alone and screened patients using magnetic resonance imaging.

The trial enrolled patients with intermediate or high-risk SMM in two phases. In phase 2, all 44 patients received lenalidomide at 25 mg daily on days 1-21 of a 28-day cycle. They also received aspirin at 325 mg on days 1-28.

In the phase 3 portion of the trial, 182 patients were randomized to observation or lenalidomide and aspirin at the aforementioned dose and schedule. Patients were stratified according to time since SMM diagnosis – 1 year or less vs. more than 1 year.

Safety

Dr. Lonial said, in general, lenalidomide was “very well tolerated.” However, 80% of patients in phase 2 and 51% in phase 3 discontinued lenalidomide due to toxicity.

The rates of treatment-related adverse events (AEs) in the phase 2 portion were 34.1% for grade 3 AEs, 11.4% for grade 4, and 4.5% for grade 5. In the phase 3 portion, 35.2% of patients had grade 3 treatment-related AEs, and 5.7% had grade 4 treatment-related AEs.

Common AEs in phase 3 were grade 4 neutrophil count decrease (4.5%) and grade 3 infections (20.5%), hypertension (9.1%), fatigue (6.8%), skin AEs (5.7%), dyspnea (5.7%), and hypokalemia (3.4%).
 

Efficacy

“It is worth noting that about 50% of patients had an objective response to lenalidomide in both the phase 2 and the phase 3 trial,” Dr. Lonial said. “I think it’s also important to realize that, in the phase 2 portion of this study, of the 44 patients enrolled, 78% of them did not progress to myeloma with a median follow-up of over 5 years.”

In phase 2, PFS was 98% at 1 year, 87% at 3 years, and 78% at 5 years.

In phase 3, PFS was 98% in the lenalidomide arm and 89% in the observation arm at 1 year. At 2 years, PFS was 93% in the lenalidomide arm and 76% in the observation arm. At 3 years, PFS was 91% in the lenalidomide arm and 66% in the observation arm.

“What’s really quite interesting is that each [risk] group appeared to benefit almost equally from the early intervention of lenalidomide as a single agent,” Dr. Lonial said. “[W]hile the high-risk group may be the target now, this may be a fertile area for investigation in the intermediate-risk group as well.”

Dr. Lonial has relationships with AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen Oncology, Juno Therapeutics, Merck, Novartis, and Takeda. The trial was funded by the National Institutes of Health.

[email protected]

SOURCE: Lonial S et al. ASCO 2019. Abstract 8001.

Lenalidomide can reduce the risk of progression from smoldering multiple myeloma (SMM) to multiple myeloma (MM), according to a phase 2/3 trial.

At 3 years, the rate of progression-free survival (PFS) was 91% in SMM patients randomized to lenalidomide and 66% in those randomized to observation.

However, more than half of patients randomized to lenalidomide discontinued treatment because of toxicity.

These results are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.

Sagar Lonial, MD, of Winship Cancer Institute, Emory University, Atlanta, discussed the results in a press briefing in advance of the meeting.

A prior trial suggested that lenalidomide plus dexamethasone can improve time to MM development and overall survival in patients with high-risk SMM (Mateos MV et al. NEJM 2013). However, inferior imaging was used in this trial, and the addition of dexamethasone hindered researchers’ ability to isolate the effects of lenalidomide, Dr. Lonial said.

With their trial (NCT01169337), Dr. Lonial and colleagues tested lenalidomide alone and screened patients using magnetic resonance imaging.

The trial enrolled patients with intermediate or high-risk SMM in two phases. In phase 2, all 44 patients received lenalidomide at 25 mg daily on days 1-21 of a 28-day cycle. They also received aspirin at 325 mg on days 1-28.

In the phase 3 portion of the trial, 182 patients were randomized to observation or lenalidomide and aspirin at the aforementioned dose and schedule. Patients were stratified according to time since SMM diagnosis – 1 year or less vs. more than 1 year.

Safety

Dr. Lonial said, in general, lenalidomide was “very well tolerated.” However, 80% of patients in phase 2 and 51% in phase 3 discontinued lenalidomide due to toxicity.

The rates of treatment-related adverse events (AEs) in the phase 2 portion were 34.1% for grade 3 AEs, 11.4% for grade 4, and 4.5% for grade 5. In the phase 3 portion, 35.2% of patients had grade 3 treatment-related AEs, and 5.7% had grade 4 treatment-related AEs.

Common AEs in phase 3 were grade 4 neutrophil count decrease (4.5%) and grade 3 infections (20.5%), hypertension (9.1%), fatigue (6.8%), skin AEs (5.7%), dyspnea (5.7%), and hypokalemia (3.4%).
 

Efficacy

“It is worth noting that about 50% of patients had an objective response to lenalidomide in both the phase 2 and the phase 3 trial,” Dr. Lonial said. “I think it’s also important to realize that, in the phase 2 portion of this study, of the 44 patients enrolled, 78% of them did not progress to myeloma with a median follow-up of over 5 years.”

In phase 2, PFS was 98% at 1 year, 87% at 3 years, and 78% at 5 years.

In phase 3, PFS was 98% in the lenalidomide arm and 89% in the observation arm at 1 year. At 2 years, PFS was 93% in the lenalidomide arm and 76% in the observation arm. At 3 years, PFS was 91% in the lenalidomide arm and 66% in the observation arm.

“What’s really quite interesting is that each [risk] group appeared to benefit almost equally from the early intervention of lenalidomide as a single agent,” Dr. Lonial said. “[W]hile the high-risk group may be the target now, this may be a fertile area for investigation in the intermediate-risk group as well.”

Dr. Lonial has relationships with AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen Oncology, Juno Therapeutics, Merck, Novartis, and Takeda. The trial was funded by the National Institutes of Health.

[email protected]

SOURCE: Lonial S et al. ASCO 2019. Abstract 8001.

Lenalidomide can reduce the risk of progression from smoldering multiple myeloma (SMM) to multiple myeloma (MM), according to a phase 2/3 trial.

At 3 years, the rate of progression-free survival (PFS) was 91% in SMM patients randomized to lenalidomide and 66% in those randomized to observation.

However, more than half of patients randomized to lenalidomide discontinued treatment because of toxicity.

These results are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.

Sagar Lonial, MD, of Winship Cancer Institute, Emory University, Atlanta, discussed the results in a press briefing in advance of the meeting.

A prior trial suggested that lenalidomide plus dexamethasone can improve time to MM development and overall survival in patients with high-risk SMM (Mateos MV et al. NEJM 2013). However, inferior imaging was used in this trial, and the addition of dexamethasone hindered researchers’ ability to isolate the effects of lenalidomide, Dr. Lonial said.

With their trial (NCT01169337), Dr. Lonial and colleagues tested lenalidomide alone and screened patients using magnetic resonance imaging.

The trial enrolled patients with intermediate or high-risk SMM in two phases. In phase 2, all 44 patients received lenalidomide at 25 mg daily on days 1-21 of a 28-day cycle. They also received aspirin at 325 mg on days 1-28.

In the phase 3 portion of the trial, 182 patients were randomized to observation or lenalidomide and aspirin at the aforementioned dose and schedule. Patients were stratified according to time since SMM diagnosis – 1 year or less vs. more than 1 year.

Safety

Dr. Lonial said, in general, lenalidomide was “very well tolerated.” However, 80% of patients in phase 2 and 51% in phase 3 discontinued lenalidomide due to toxicity.

The rates of treatment-related adverse events (AEs) in the phase 2 portion were 34.1% for grade 3 AEs, 11.4% for grade 4, and 4.5% for grade 5. In the phase 3 portion, 35.2% of patients had grade 3 treatment-related AEs, and 5.7% had grade 4 treatment-related AEs.

Common AEs in phase 3 were grade 4 neutrophil count decrease (4.5%) and grade 3 infections (20.5%), hypertension (9.1%), fatigue (6.8%), skin AEs (5.7%), dyspnea (5.7%), and hypokalemia (3.4%).
 

Efficacy

“It is worth noting that about 50% of patients had an objective response to lenalidomide in both the phase 2 and the phase 3 trial,” Dr. Lonial said. “I think it’s also important to realize that, in the phase 2 portion of this study, of the 44 patients enrolled, 78% of them did not progress to myeloma with a median follow-up of over 5 years.”

In phase 2, PFS was 98% at 1 year, 87% at 3 years, and 78% at 5 years.

In phase 3, PFS was 98% in the lenalidomide arm and 89% in the observation arm at 1 year. At 2 years, PFS was 93% in the lenalidomide arm and 76% in the observation arm. At 3 years, PFS was 91% in the lenalidomide arm and 66% in the observation arm.

“What’s really quite interesting is that each [risk] group appeared to benefit almost equally from the early intervention of lenalidomide as a single agent,” Dr. Lonial said. “[W]hile the high-risk group may be the target now, this may be a fertile area for investigation in the intermediate-risk group as well.”

Dr. Lonial has relationships with AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen Oncology, Juno Therapeutics, Merck, Novartis, and Takeda. The trial was funded by the National Institutes of Health.

[email protected]

SOURCE: Lonial S et al. ASCO 2019. Abstract 8001.

TORONTO – High-intensity statin therapy was associated with markedly reduced rates of knee and hip replacement surgery for osteoarthritis or rheumatoid arthritis in a longitudinal cohort study comparing nearly 180,000 statin users with an equal number of propensity-matched nonusers, Jie Wei, PhD, reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

Less intensive statin therapy was associated with significantly less need for joint replacement surgery in rheumatoid arthritis patients, but not in those with osteoarthritis, she said at the meeting, sponsored by the Osteoarthritis Research Society International.

“In summary, statins may reduce the risk of joint replacement, especially when given at high strength and in people with rheumatoid arthritis,” said Dr. Wei, an epidemiologist at Massachusetts General Hospital, Boston, and Central South University in Changsha, Hunan, China.

She was quick to note that this study can’t be considered the final, definitive word on the topic, since other investigators’ studies of the relationship between statin usage and joint replacement surgery for arthritis have yielded conflicting results. However, given the thoroughly established super-favorable risk/benefit ratio of statins for the prevention of cardiovascular morbidity and mortality, the possibility of a prospective, randomized, controlled trial addressing the joint surgery issue is for ethical reasons a train that’s left the station.

Dr. Wei presented an analysis drawn from the U.K. Clinical Practice Research Datalink for the years 1989 through mid-2017. The initial sample included the medical records of 17.1 million patients, or 26% of the total U.K. population. From that massive pool, she and her coinvestigators zeroed in on 178,467 statin users and an equal number of non–statin-user controls under the care of 718 primary care physicians, with the pairs propensity score-matched on the basis of age, gender, locality, comorbid conditions, nonstatin medications, lifestyle factors, and duration of rheumatoid arthritis or osteoarthritis. The mean age of the matched pairs was 62 years, 52% were women, and the mean prospective follow-up was 6.5 years.

The use of high-intensity statin therapy – for example, atorvastatin at 40-80 mg/day or rosuvastatin (Crestor) at 20-40 mg/day – was independently associated with a 21% reduction in the risk of knee or hip replacement surgery for osteoarthritis and a 90% reduction for rheumatoid arthritis, compared with statin nonusers. Notably, joint replacement surgery for osteoarthritis was roughly 25-fold more common than for rheumatoid arthritis.

Statin therapy overall, including the more widely prescribed low- and intermediate-intensity regimens, was associated with a 23% reduction in joint replacement surgery for rheumatoid arthritis, compared with statin nonusers, but had no significant impact on surgery for the osteoarthritis population.

A couple of distinguished American rheumatologists in the audience rose to voice reluctance about drawing broad conclusions from this study.

“Bias, as you’ve said yourself, is a bit of a concern,” said David T. Felson, MD, professor of medicine and public health and director of clinical epidemiology at Boston University.

He was troubled that the study design was such that anyone who filled as few as two statin prescriptions during the more than 6-year study period was categorized as a statin user. That, he said, muddies the waters. Does the database contain information on duration of statin therapy, and whether joint replacement surgery was more likely to occur when patients were on or off statin therapy? he asked.

It does, Dr. Wei replied, adding that she will take that suggestion for additional analysis back to her international team of coinvestigators.

“It seems to me,” said Jeffrey N. Katz, MD, “that the major risk of potential bias is that people who were provided high-intensity statins were prescribed that because they were at risk for or had cardiac disease.”

That high cardiovascular risk might have curbed orthopedic surgeons’ enthusiasm to operate. Thus, it would be helpful to learn whether patients who underwent joint replacement were less likely to have undergone coronary revascularization or other cardiac interventions than were those without joint replacement, according to Dr. Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.

Dr. Wei agreed that confounding by indication is always a possibility in an observational study such as this. Identification of a plausible mechanism by which statins might reduce the risk of joint replacement surgery in rheumatoid arthritis – something that hasn’t happened yet – would help counter such concerns.

She noted that a separate recent analysis of the U.K. Clinical Practice Research Datalink by other investigators concluded that statin therapy started up to 5 years following total hip or knee replacement was associated with a significantly reduced risk of revision arthroplasty. Moreover, the benefit was treatment duration-dependent: Patients on statin therapy for more than 5 years were 26% less likely to undergo revision arthroplasty than were those on a statin for less than 1 year (J Rheumatol. 2019 Mar 15. doi: 10.3899/jrheum.180574).

On the other hand, Swedish investigators found that statin use wasn’t associated with a reduced risk of consultation or surgery for osteoarthritis in a pooled analysis of four cohort studies totaling more than 132,000 Swedes followed for 7.5 years (Osteoarthritis Cartilage. 2017 Nov;25[11]:1804-13).

Dr. Wei reported having no financial conflicts regarding the study, which was supported by the National Clinical Research Center of Geriatric Disorders in Hunan, China, and several British universities.

[email protected]

SOURCE: Sarmanova A et al. Osteoarthritis cartilage. 2019 Apr;27[suppl 1]:S78-S79. Abstract 77.

TORONTO – High-intensity statin therapy was associated with markedly reduced rates of knee and hip replacement surgery for osteoarthritis or rheumatoid arthritis in a longitudinal cohort study comparing nearly 180,000 statin users with an equal number of propensity-matched nonusers, Jie Wei, PhD, reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

Less intensive statin therapy was associated with significantly less need for joint replacement surgery in rheumatoid arthritis patients, but not in those with osteoarthritis, she said at the meeting, sponsored by the Osteoarthritis Research Society International.

“In summary, statins may reduce the risk of joint replacement, especially when given at high strength and in people with rheumatoid arthritis,” said Dr. Wei, an epidemiologist at Massachusetts General Hospital, Boston, and Central South University in Changsha, Hunan, China.

She was quick to note that this study can’t be considered the final, definitive word on the topic, since other investigators’ studies of the relationship between statin usage and joint replacement surgery for arthritis have yielded conflicting results. However, given the thoroughly established super-favorable risk/benefit ratio of statins for the prevention of cardiovascular morbidity and mortality, the possibility of a prospective, randomized, controlled trial addressing the joint surgery issue is for ethical reasons a train that’s left the station.

Dr. Wei presented an analysis drawn from the U.K. Clinical Practice Research Datalink for the years 1989 through mid-2017. The initial sample included the medical records of 17.1 million patients, or 26% of the total U.K. population. From that massive pool, she and her coinvestigators zeroed in on 178,467 statin users and an equal number of non–statin-user controls under the care of 718 primary care physicians, with the pairs propensity score-matched on the basis of age, gender, locality, comorbid conditions, nonstatin medications, lifestyle factors, and duration of rheumatoid arthritis or osteoarthritis. The mean age of the matched pairs was 62 years, 52% were women, and the mean prospective follow-up was 6.5 years.

The use of high-intensity statin therapy – for example, atorvastatin at 40-80 mg/day or rosuvastatin (Crestor) at 20-40 mg/day – was independently associated with a 21% reduction in the risk of knee or hip replacement surgery for osteoarthritis and a 90% reduction for rheumatoid arthritis, compared with statin nonusers. Notably, joint replacement surgery for osteoarthritis was roughly 25-fold more common than for rheumatoid arthritis.

Statin therapy overall, including the more widely prescribed low- and intermediate-intensity regimens, was associated with a 23% reduction in joint replacement surgery for rheumatoid arthritis, compared with statin nonusers, but had no significant impact on surgery for the osteoarthritis population.

A couple of distinguished American rheumatologists in the audience rose to voice reluctance about drawing broad conclusions from this study.

“Bias, as you’ve said yourself, is a bit of a concern,” said David T. Felson, MD, professor of medicine and public health and director of clinical epidemiology at Boston University.

He was troubled that the study design was such that anyone who filled as few as two statin prescriptions during the more than 6-year study period was categorized as a statin user. That, he said, muddies the waters. Does the database contain information on duration of statin therapy, and whether joint replacement surgery was more likely to occur when patients were on or off statin therapy? he asked.

It does, Dr. Wei replied, adding that she will take that suggestion for additional analysis back to her international team of coinvestigators.

“It seems to me,” said Jeffrey N. Katz, MD, “that the major risk of potential bias is that people who were provided high-intensity statins were prescribed that because they were at risk for or had cardiac disease.”

That high cardiovascular risk might have curbed orthopedic surgeons’ enthusiasm to operate. Thus, it would be helpful to learn whether patients who underwent joint replacement were less likely to have undergone coronary revascularization or other cardiac interventions than were those without joint replacement, according to Dr. Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.

Dr. Wei agreed that confounding by indication is always a possibility in an observational study such as this. Identification of a plausible mechanism by which statins might reduce the risk of joint replacement surgery in rheumatoid arthritis – something that hasn’t happened yet – would help counter such concerns.

She noted that a separate recent analysis of the U.K. Clinical Practice Research Datalink by other investigators concluded that statin therapy started up to 5 years following total hip or knee replacement was associated with a significantly reduced risk of revision arthroplasty. Moreover, the benefit was treatment duration-dependent: Patients on statin therapy for more than 5 years were 26% less likely to undergo revision arthroplasty than were those on a statin for less than 1 year (J Rheumatol. 2019 Mar 15. doi: 10.3899/jrheum.180574).

On the other hand, Swedish investigators found that statin use wasn’t associated with a reduced risk of consultation or surgery for osteoarthritis in a pooled analysis of four cohort studies totaling more than 132,000 Swedes followed for 7.5 years (Osteoarthritis Cartilage. 2017 Nov;25[11]:1804-13).

Dr. Wei reported having no financial conflicts regarding the study, which was supported by the National Clinical Research Center of Geriatric Disorders in Hunan, China, and several British universities.

[email protected]

SOURCE: Sarmanova A et al. Osteoarthritis cartilage. 2019 Apr;27[suppl 1]:S78-S79. Abstract 77.

TORONTO – High-intensity statin therapy was associated with markedly reduced rates of knee and hip replacement surgery for osteoarthritis or rheumatoid arthritis in a longitudinal cohort study comparing nearly 180,000 statin users with an equal number of propensity-matched nonusers, Jie Wei, PhD, reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

Less intensive statin therapy was associated with significantly less need for joint replacement surgery in rheumatoid arthritis patients, but not in those with osteoarthritis, she said at the meeting, sponsored by the Osteoarthritis Research Society International.

“In summary, statins may reduce the risk of joint replacement, especially when given at high strength and in people with rheumatoid arthritis,” said Dr. Wei, an epidemiologist at Massachusetts General Hospital, Boston, and Central South University in Changsha, Hunan, China.

She was quick to note that this study can’t be considered the final, definitive word on the topic, since other investigators’ studies of the relationship between statin usage and joint replacement surgery for arthritis have yielded conflicting results. However, given the thoroughly established super-favorable risk/benefit ratio of statins for the prevention of cardiovascular morbidity and mortality, the possibility of a prospective, randomized, controlled trial addressing the joint surgery issue is for ethical reasons a train that’s left the station.

Dr. Wei presented an analysis drawn from the U.K. Clinical Practice Research Datalink for the years 1989 through mid-2017. The initial sample included the medical records of 17.1 million patients, or 26% of the total U.K. population. From that massive pool, she and her coinvestigators zeroed in on 178,467 statin users and an equal number of non–statin-user controls under the care of 718 primary care physicians, with the pairs propensity score-matched on the basis of age, gender, locality, comorbid conditions, nonstatin medications, lifestyle factors, and duration of rheumatoid arthritis or osteoarthritis. The mean age of the matched pairs was 62 years, 52% were women, and the mean prospective follow-up was 6.5 years.

The use of high-intensity statin therapy – for example, atorvastatin at 40-80 mg/day or rosuvastatin (Crestor) at 20-40 mg/day – was independently associated with a 21% reduction in the risk of knee or hip replacement surgery for osteoarthritis and a 90% reduction for rheumatoid arthritis, compared with statin nonusers. Notably, joint replacement surgery for osteoarthritis was roughly 25-fold more common than for rheumatoid arthritis.

Statin therapy overall, including the more widely prescribed low- and intermediate-intensity regimens, was associated with a 23% reduction in joint replacement surgery for rheumatoid arthritis, compared with statin nonusers, but had no significant impact on surgery for the osteoarthritis population.

A couple of distinguished American rheumatologists in the audience rose to voice reluctance about drawing broad conclusions from this study.

“Bias, as you’ve said yourself, is a bit of a concern,” said David T. Felson, MD, professor of medicine and public health and director of clinical epidemiology at Boston University.

He was troubled that the study design was such that anyone who filled as few as two statin prescriptions during the more than 6-year study period was categorized as a statin user. That, he said, muddies the waters. Does the database contain information on duration of statin therapy, and whether joint replacement surgery was more likely to occur when patients were on or off statin therapy? he asked.

It does, Dr. Wei replied, adding that she will take that suggestion for additional analysis back to her international team of coinvestigators.

“It seems to me,” said Jeffrey N. Katz, MD, “that the major risk of potential bias is that people who were provided high-intensity statins were prescribed that because they were at risk for or had cardiac disease.”

That high cardiovascular risk might have curbed orthopedic surgeons’ enthusiasm to operate. Thus, it would be helpful to learn whether patients who underwent joint replacement were less likely to have undergone coronary revascularization or other cardiac interventions than were those without joint replacement, according to Dr. Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.

Dr. Wei agreed that confounding by indication is always a possibility in an observational study such as this. Identification of a plausible mechanism by which statins might reduce the risk of joint replacement surgery in rheumatoid arthritis – something that hasn’t happened yet – would help counter such concerns.

She noted that a separate recent analysis of the U.K. Clinical Practice Research Datalink by other investigators concluded that statin therapy started up to 5 years following total hip or knee replacement was associated with a significantly reduced risk of revision arthroplasty. Moreover, the benefit was treatment duration-dependent: Patients on statin therapy for more than 5 years were 26% less likely to undergo revision arthroplasty than were those on a statin for less than 1 year (J Rheumatol. 2019 Mar 15. doi: 10.3899/jrheum.180574).

On the other hand, Swedish investigators found that statin use wasn’t associated with a reduced risk of consultation or surgery for osteoarthritis in a pooled analysis of four cohort studies totaling more than 132,000 Swedes followed for 7.5 years (Osteoarthritis Cartilage. 2017 Nov;25[11]:1804-13).

Dr. Wei reported having no financial conflicts regarding the study, which was supported by the National Clinical Research Center of Geriatric Disorders in Hunan, China, and several British universities.

[email protected]

SOURCE: Sarmanova A et al. Osteoarthritis cartilage. 2019 Apr;27[suppl 1]:S78-S79. Abstract 77.

U.S. health care personnel no longer need to undergo routine tuberculosis testing in the absence of known exposure, according to new screening guidelines from the National Tuberculosis Controllers Association and CDC.

The revised guidelines on tuberculosis screening, testing, and treatment of U.S. health care personnel, published in Morbidity and Mortality Weekly Report, are the first update since 2005. The new recommendations reflect a reduction in concern about U.S. health care personnel’s risk of occupational exposure to latent and active tuberculosis infection.

Lynn E. Sosa, MD, from the Connecticut Department of Public Health and National Tuberculosis Controllers Association, and coauthors wrote that rates of tuberculosis infection in the United States have declined by 73% since 1991, from 10.4/100,000 population in 1991 to 2.8/100,000 in 2017. This has been matched by similar declines among health care workers, which the authors said raised questions about the cost-effectiveness of the previously recommended routine serial occupational testing.

“In addition, a recent retrospective cohort study of approximately 40,000 health care personnel at a tertiary U.S. medical center in a low TB-incidence state found an extremely low rate of TST conversion (0.3%) during 1998-2014, with a limited proportion attributable to occupational exposure,” they wrote.

The new guidelines recommend health care personnel undergo baseline or preplacement tuberculosis testing with an interferon-gamma release assay (IGRA) or a tuberculin skin test (TST), as well as individual risk assessment and symptom evaluation.

The individual risk assessment considers whether the person has lived in a country with a high tuberculosis rate, whether they are immunosuppressed, or whether they have had close contact with someone with infectious tuberculosis.

This risk assessment can help decide how to interpret an initial positive test result, the authors said.

“For example, health care personnel with a positive test who are asymptomatic, unlikely to be infected with M. [Mycobacterium] tuberculosis, and at low risk for progression on the basis of their risk assessment should have a second test (either an IGRA or a TST) as recommended in the 2017 TB diagnostic guidelines of the American Thoracic Society, Infectious Diseases Society of America, and CDC,” they wrote. “In this example, the health care personnel should be considered infected with M. tuberculosis only if both the first and second tests are positive.”

After that baseline testing, personnel do not need to undergo routine serial testing except in the case of known exposure or ongoing transmission. The guideline authors suggested serial screening might be considered for health care workers whose work puts them at greater risk – for example, pulmonologists or respiratory therapists – or for those working in settings in which transmission has happened in the past.

For personnel with latent tuberculosis infection, the guidelines recommend “encouragement of treatment” unless it is contraindicated, and annual symptom screening in those not undergoing treatment.

The guideline committee also advocated for annual tuberculosis education for all health care workers.

The new recommendations were based on a systematic review of 36 studies of tuberculosis screening and testing among health care per­sonnel, 16 of which were performed in the United States, and all but two of which were conducted in a hospital setting.

The authors stressed that recommendations from the 2005 CDC guidelines – which do not pertain to health care personnel screening, testing, treatment and education – remain unchanged.

One author declared personal fees from the National Tuberculosis Controllers Association during the conduct of the study. Two others reported unrelated grants and personal fees from private industry. No other conflicts of interest were disclosed.

SOURCE: Sosa L et al. MMWR. 2019;68:439-43.

U.S. health care personnel no longer need to undergo routine tuberculosis testing in the absence of known exposure, according to new screening guidelines from the National Tuberculosis Controllers Association and CDC.

The revised guidelines on tuberculosis screening, testing, and treatment of U.S. health care personnel, published in Morbidity and Mortality Weekly Report, are the first update since 2005. The new recommendations reflect a reduction in concern about U.S. health care personnel’s risk of occupational exposure to latent and active tuberculosis infection.

Lynn E. Sosa, MD, from the Connecticut Department of Public Health and National Tuberculosis Controllers Association, and coauthors wrote that rates of tuberculosis infection in the United States have declined by 73% since 1991, from 10.4/100,000 population in 1991 to 2.8/100,000 in 2017. This has been matched by similar declines among health care workers, which the authors said raised questions about the cost-effectiveness of the previously recommended routine serial occupational testing.

“In addition, a recent retrospective cohort study of approximately 40,000 health care personnel at a tertiary U.S. medical center in a low TB-incidence state found an extremely low rate of TST conversion (0.3%) during 1998-2014, with a limited proportion attributable to occupational exposure,” they wrote.

The new guidelines recommend health care personnel undergo baseline or preplacement tuberculosis testing with an interferon-gamma release assay (IGRA) or a tuberculin skin test (TST), as well as individual risk assessment and symptom evaluation.

The individual risk assessment considers whether the person has lived in a country with a high tuberculosis rate, whether they are immunosuppressed, or whether they have had close contact with someone with infectious tuberculosis.

This risk assessment can help decide how to interpret an initial positive test result, the authors said.

“For example, health care personnel with a positive test who are asymptomatic, unlikely to be infected with M. [Mycobacterium] tuberculosis, and at low risk for progression on the basis of their risk assessment should have a second test (either an IGRA or a TST) as recommended in the 2017 TB diagnostic guidelines of the American Thoracic Society, Infectious Diseases Society of America, and CDC,” they wrote. “In this example, the health care personnel should be considered infected with M. tuberculosis only if both the first and second tests are positive.”

After that baseline testing, personnel do not need to undergo routine serial testing except in the case of known exposure or ongoing transmission. The guideline authors suggested serial screening might be considered for health care workers whose work puts them at greater risk – for example, pulmonologists or respiratory therapists – or for those working in settings in which transmission has happened in the past.

For personnel with latent tuberculosis infection, the guidelines recommend “encouragement of treatment” unless it is contraindicated, and annual symptom screening in those not undergoing treatment.

The guideline committee also advocated for annual tuberculosis education for all health care workers.

The new recommendations were based on a systematic review of 36 studies of tuberculosis screening and testing among health care per­sonnel, 16 of which were performed in the United States, and all but two of which were conducted in a hospital setting.

The authors stressed that recommendations from the 2005 CDC guidelines – which do not pertain to health care personnel screening, testing, treatment and education – remain unchanged.

One author declared personal fees from the National Tuberculosis Controllers Association during the conduct of the study. Two others reported unrelated grants and personal fees from private industry. No other conflicts of interest were disclosed.

SOURCE: Sosa L et al. MMWR. 2019;68:439-43.

U.S. health care personnel no longer need to undergo routine tuberculosis testing in the absence of known exposure, according to new screening guidelines from the National Tuberculosis Controllers Association and CDC.

The revised guidelines on tuberculosis screening, testing, and treatment of U.S. health care personnel, published in Morbidity and Mortality Weekly Report, are the first update since 2005. The new recommendations reflect a reduction in concern about U.S. health care personnel’s risk of occupational exposure to latent and active tuberculosis infection.

Lynn E. Sosa, MD, from the Connecticut Department of Public Health and National Tuberculosis Controllers Association, and coauthors wrote that rates of tuberculosis infection in the United States have declined by 73% since 1991, from 10.4/100,000 population in 1991 to 2.8/100,000 in 2017. This has been matched by similar declines among health care workers, which the authors said raised questions about the cost-effectiveness of the previously recommended routine serial occupational testing.

“In addition, a recent retrospective cohort study of approximately 40,000 health care personnel at a tertiary U.S. medical center in a low TB-incidence state found an extremely low rate of TST conversion (0.3%) during 1998-2014, with a limited proportion attributable to occupational exposure,” they wrote.

The new guidelines recommend health care personnel undergo baseline or preplacement tuberculosis testing with an interferon-gamma release assay (IGRA) or a tuberculin skin test (TST), as well as individual risk assessment and symptom evaluation.

The individual risk assessment considers whether the person has lived in a country with a high tuberculosis rate, whether they are immunosuppressed, or whether they have had close contact with someone with infectious tuberculosis.

This risk assessment can help decide how to interpret an initial positive test result, the authors said.

“For example, health care personnel with a positive test who are asymptomatic, unlikely to be infected with M. [Mycobacterium] tuberculosis, and at low risk for progression on the basis of their risk assessment should have a second test (either an IGRA or a TST) as recommended in the 2017 TB diagnostic guidelines of the American Thoracic Society, Infectious Diseases Society of America, and CDC,” they wrote. “In this example, the health care personnel should be considered infected with M. tuberculosis only if both the first and second tests are positive.”

After that baseline testing, personnel do not need to undergo routine serial testing except in the case of known exposure or ongoing transmission. The guideline authors suggested serial screening might be considered for health care workers whose work puts them at greater risk – for example, pulmonologists or respiratory therapists – or for those working in settings in which transmission has happened in the past.

For personnel with latent tuberculosis infection, the guidelines recommend “encouragement of treatment” unless it is contraindicated, and annual symptom screening in those not undergoing treatment.

The guideline committee also advocated for annual tuberculosis education for all health care workers.

The new recommendations were based on a systematic review of 36 studies of tuberculosis screening and testing among health care per­sonnel, 16 of which were performed in the United States, and all but two of which were conducted in a hospital setting.

The authors stressed that recommendations from the 2005 CDC guidelines – which do not pertain to health care personnel screening, testing, treatment and education – remain unchanged.

One author declared personal fees from the National Tuberculosis Controllers Association during the conduct of the study. Two others reported unrelated grants and personal fees from private industry. No other conflicts of interest were disclosed.

SOURCE: Sosa L et al. MMWR. 2019;68:439-43.

Effective EHRs, supportive leadership, and robust physician-patient communication are key elements to successful implementation of the Center for Medicare & Medicaid Services’ Oncology Care Model (OCM), according to a summary of experiences published in the Journal of the National Cancer Institute.

Lead author Ronald M. Kline, MD, of the Center for Medicare and Medicaid Innovation and colleagues interviewed three practices and one network of practices that have employed the agency’s OCM, which uses an episode-based payment structure and aims to enhance care quality, boost high-value care, and reduce costs. The model uses a two-part payment approach, which includes monthly care management payments and potential retrospective, performance-based payments based on lowering episodes’ total cost of care. Institutions interviewed for the summary were the Clearview Cancer Institute, based in Huntsville, Ala.; the Lancaster General Medical Group, based in Lancaster, Pa.; the University of Texas, Dallas; and the U.S. Oncology Network – McKesson Specialty Health, which operates across 25 states. Representatives from each institution answered questions about their successes and challenges with the model, including how the OCM has impacted work flow and patient care.

A central theme that emerged during the interviews was the importance of communication improvements among health care teams and within patient relationships to effectively implement OCM. For example, the Clearview Cancer Institute reported that, from the top down, communication has been a key factor in transforming patient care under the model. Weekly and monthly feedback reports for Clearview clinical employees paired with active efforts to improve communications between administrative and clinical staff have boosted collaboration among teams and ensured that OCM requirements are met, according to the interview summary. As part of OCM, participants must enact certain communication enhancements, including physician-patient discussion of treatment risks and goals through structured communications, such as the Institute of Medicine (IOM) Care Management Plan. Clearview officials reported that, before model implementation, about 2% of its patients had their advance care status documented in the EHR, compared with more than 90% of patients who now have such information documented.

For the Lancaster General Medical Group, revamping how and what type of information was documented in its EHR vastly improved its practice work flow and allowed staff to make more informed decisions as part of its OCM efforts. For example, the model’s requirement for the IOM care plan inspired Lancaster leaders to redesign its informed consent process with a sharper focus on shared decision making, advance care planning, and anticancer treatment education for patients, according to the summary. Lancaster also changed its process for starting an office visit in its EHR so that physicians and staff must review or perform important care management tasks associated with OCM implementation. The “rooming tool” developed for this goal became so beneficial that Lancaster’s EHR vendor will soon be making the tool available nationally.

However, for the University of Texas, Dallas, technology deficiencies within its EHR have posed challenges for instituting elements of the OCM. Program administrators underestimated the effort required to tailor systems to meet OCM metrics across its two participating institutions, university officials reported in the summary. A number of key activities required for OCM transformation have been delayed as the institution attempts to align work flows with its technology, including harmonization of triage scripts, mechanisms of nurse triage documentation, consistent use of staging and oncology history modules, and implementation of a clinical pathways program. Efficient use of technology remains the university’s biggest challenge to the model, according to program administrators.

Meanwhile, the U.S. Oncology Network emphasized the value of designating physician leaders responsible for driving change at each of its OCM-participating sites. Network officials reported that physician champions at each site share information about OCM claims data with colleagues and identify opportunities for improvement. For example, data regarding outliers in hospitalization rates, ED visits, treatment plans, quality metric documentation, and advance care planning. U.S. Oncology Network leaders stressed that OCM program success cannot be achieved without strong physician leadership and engagement.

Dr. Kline and colleagues concluded that there is not a single path to patient-centered, high-value care, writing that the CMS made OCM flexible so that practices may discover their own paths to practice transformation.

“Regardless of structure, however, participation in OCM and other similar value-based models is an acknowledgment of anticipated future health system changes in the U.S. and a desire to gain experience in this new paradigm earlier in the process,” Dr. Kline wrote in the summary. “As these practices have described, the path is sometimes challenging, but is intended to ultimately lead to improved patient engagement and care.”

CMS’ Oncology Care Model started in July 2016 and the performance period ends in June 2021. Participants include 176 practices and 10 payers. For more information on the model, visit the CMS website.

Two coauthors are employees of CMS. Other coauthors are employees or partners in OCM practices or their management companies, which receive payments from CMS for their participation in OCM.

SOURCE: Kline RM et al. J Natl Cancer Inst. 2019 May 3. doi: 10.1093/jnci/djz072.

Effective EHRs, supportive leadership, and robust physician-patient communication are key elements to successful implementation of the Center for Medicare & Medicaid Services’ Oncology Care Model (OCM), according to a summary of experiences published in the Journal of the National Cancer Institute.

Lead author Ronald M. Kline, MD, of the Center for Medicare and Medicaid Innovation and colleagues interviewed three practices and one network of practices that have employed the agency’s OCM, which uses an episode-based payment structure and aims to enhance care quality, boost high-value care, and reduce costs. The model uses a two-part payment approach, which includes monthly care management payments and potential retrospective, performance-based payments based on lowering episodes’ total cost of care. Institutions interviewed for the summary were the Clearview Cancer Institute, based in Huntsville, Ala.; the Lancaster General Medical Group, based in Lancaster, Pa.; the University of Texas, Dallas; and the U.S. Oncology Network – McKesson Specialty Health, which operates across 25 states. Representatives from each institution answered questions about their successes and challenges with the model, including how the OCM has impacted work flow and patient care.

A central theme that emerged during the interviews was the importance of communication improvements among health care teams and within patient relationships to effectively implement OCM. For example, the Clearview Cancer Institute reported that, from the top down, communication has been a key factor in transforming patient care under the model. Weekly and monthly feedback reports for Clearview clinical employees paired with active efforts to improve communications between administrative and clinical staff have boosted collaboration among teams and ensured that OCM requirements are met, according to the interview summary. As part of OCM, participants must enact certain communication enhancements, including physician-patient discussion of treatment risks and goals through structured communications, such as the Institute of Medicine (IOM) Care Management Plan. Clearview officials reported that, before model implementation, about 2% of its patients had their advance care status documented in the EHR, compared with more than 90% of patients who now have such information documented.

For the Lancaster General Medical Group, revamping how and what type of information was documented in its EHR vastly improved its practice work flow and allowed staff to make more informed decisions as part of its OCM efforts. For example, the model’s requirement for the IOM care plan inspired Lancaster leaders to redesign its informed consent process with a sharper focus on shared decision making, advance care planning, and anticancer treatment education for patients, according to the summary. Lancaster also changed its process for starting an office visit in its EHR so that physicians and staff must review or perform important care management tasks associated with OCM implementation. The “rooming tool” developed for this goal became so beneficial that Lancaster’s EHR vendor will soon be making the tool available nationally.

However, for the University of Texas, Dallas, technology deficiencies within its EHR have posed challenges for instituting elements of the OCM. Program administrators underestimated the effort required to tailor systems to meet OCM metrics across its two participating institutions, university officials reported in the summary. A number of key activities required for OCM transformation have been delayed as the institution attempts to align work flows with its technology, including harmonization of triage scripts, mechanisms of nurse triage documentation, consistent use of staging and oncology history modules, and implementation of a clinical pathways program. Efficient use of technology remains the university’s biggest challenge to the model, according to program administrators.

Meanwhile, the U.S. Oncology Network emphasized the value of designating physician leaders responsible for driving change at each of its OCM-participating sites. Network officials reported that physician champions at each site share information about OCM claims data with colleagues and identify opportunities for improvement. For example, data regarding outliers in hospitalization rates, ED visits, treatment plans, quality metric documentation, and advance care planning. U.S. Oncology Network leaders stressed that OCM program success cannot be achieved without strong physician leadership and engagement.

Dr. Kline and colleagues concluded that there is not a single path to patient-centered, high-value care, writing that the CMS made OCM flexible so that practices may discover their own paths to practice transformation.

“Regardless of structure, however, participation in OCM and other similar value-based models is an acknowledgment of anticipated future health system changes in the U.S. and a desire to gain experience in this new paradigm earlier in the process,” Dr. Kline wrote in the summary. “As these practices have described, the path is sometimes challenging, but is intended to ultimately lead to improved patient engagement and care.”

CMS’ Oncology Care Model started in July 2016 and the performance period ends in June 2021. Participants include 176 practices and 10 payers. For more information on the model, visit the CMS website.

Two coauthors are employees of CMS. Other coauthors are employees or partners in OCM practices or their management companies, which receive payments from CMS for their participation in OCM.

SOURCE: Kline RM et al. J Natl Cancer Inst. 2019 May 3. doi: 10.1093/jnci/djz072.

Effective EHRs, supportive leadership, and robust physician-patient communication are key elements to successful implementation of the Center for Medicare & Medicaid Services’ Oncology Care Model (OCM), according to a summary of experiences published in the Journal of the National Cancer Institute.

Lead author Ronald M. Kline, MD, of the Center for Medicare and Medicaid Innovation and colleagues interviewed three practices and one network of practices that have employed the agency’s OCM, which uses an episode-based payment structure and aims to enhance care quality, boost high-value care, and reduce costs. The model uses a two-part payment approach, which includes monthly care management payments and potential retrospective, performance-based payments based on lowering episodes’ total cost of care. Institutions interviewed for the summary were the Clearview Cancer Institute, based in Huntsville, Ala.; the Lancaster General Medical Group, based in Lancaster, Pa.; the University of Texas, Dallas; and the U.S. Oncology Network – McKesson Specialty Health, which operates across 25 states. Representatives from each institution answered questions about their successes and challenges with the model, including how the OCM has impacted work flow and patient care.

A central theme that emerged during the interviews was the importance of communication improvements among health care teams and within patient relationships to effectively implement OCM. For example, the Clearview Cancer Institute reported that, from the top down, communication has been a key factor in transforming patient care under the model. Weekly and monthly feedback reports for Clearview clinical employees paired with active efforts to improve communications between administrative and clinical staff have boosted collaboration among teams and ensured that OCM requirements are met, according to the interview summary. As part of OCM, participants must enact certain communication enhancements, including physician-patient discussion of treatment risks and goals through structured communications, such as the Institute of Medicine (IOM) Care Management Plan. Clearview officials reported that, before model implementation, about 2% of its patients had their advance care status documented in the EHR, compared with more than 90% of patients who now have such information documented.

For the Lancaster General Medical Group, revamping how and what type of information was documented in its EHR vastly improved its practice work flow and allowed staff to make more informed decisions as part of its OCM efforts. For example, the model’s requirement for the IOM care plan inspired Lancaster leaders to redesign its informed consent process with a sharper focus on shared decision making, advance care planning, and anticancer treatment education for patients, according to the summary. Lancaster also changed its process for starting an office visit in its EHR so that physicians and staff must review or perform important care management tasks associated with OCM implementation. The “rooming tool” developed for this goal became so beneficial that Lancaster’s EHR vendor will soon be making the tool available nationally.

However, for the University of Texas, Dallas, technology deficiencies within its EHR have posed challenges for instituting elements of the OCM. Program administrators underestimated the effort required to tailor systems to meet OCM metrics across its two participating institutions, university officials reported in the summary. A number of key activities required for OCM transformation have been delayed as the institution attempts to align work flows with its technology, including harmonization of triage scripts, mechanisms of nurse triage documentation, consistent use of staging and oncology history modules, and implementation of a clinical pathways program. Efficient use of technology remains the university’s biggest challenge to the model, according to program administrators.

Meanwhile, the U.S. Oncology Network emphasized the value of designating physician leaders responsible for driving change at each of its OCM-participating sites. Network officials reported that physician champions at each site share information about OCM claims data with colleagues and identify opportunities for improvement. For example, data regarding outliers in hospitalization rates, ED visits, treatment plans, quality metric documentation, and advance care planning. U.S. Oncology Network leaders stressed that OCM program success cannot be achieved without strong physician leadership and engagement.

Dr. Kline and colleagues concluded that there is not a single path to patient-centered, high-value care, writing that the CMS made OCM flexible so that practices may discover their own paths to practice transformation.

“Regardless of structure, however, participation in OCM and other similar value-based models is an acknowledgment of anticipated future health system changes in the U.S. and a desire to gain experience in this new paradigm earlier in the process,” Dr. Kline wrote in the summary. “As these practices have described, the path is sometimes challenging, but is intended to ultimately lead to improved patient engagement and care.”

CMS’ Oncology Care Model started in July 2016 and the performance period ends in June 2021. Participants include 176 practices and 10 payers. For more information on the model, visit the CMS website.

Two coauthors are employees of CMS. Other coauthors are employees or partners in OCM practices or their management companies, which receive payments from CMS for their participation in OCM.

SOURCE: Kline RM et al. J Natl Cancer Inst. 2019 May 3. doi: 10.1093/jnci/djz072.