Dr. Scott Krugman, Chair of Pediatrics and Director of Medical Education at MedStar Franklin Square Medical Center in Baltimore, and Dr. Miguel Villagra, Medical Director of the Hospitalist Department at White River Medical Center in Batesville, AR talk about how residents and early career MDs process that decision.

Dr. Scott Krugman, Chair of Pediatrics and Director of Medical Education at MedStar Franklin Square Medical Center in Baltimore, and Dr. Miguel Villagra, Medical Director of the Hospitalist Department at White River Medical Center in Batesville, AR talk about how residents and early career MDs process that decision.

Dr. Scott Krugman, Chair of Pediatrics and Director of Medical Education at MedStar Franklin Square Medical Center in Baltimore, and Dr. Miguel Villagra, Medical Director of the Hospitalist Department at White River Medical Center in Batesville, AR talk about how residents and early career MDs process that decision.

The number of pregnant women with laboratory evidence of Zika virus infection jumped by 189 during the week ending Aug. 11, with most of the increase coming in the U.S. territories, according to the Centers for Disease Control and Prevention.

The territories reported 170 new cases of Zika infection for that week, while the 50 states and the District of Columbia had 19 new cases in pregnant women. There have been 1,220 cases in pregnant women in the United States so far: 691 in the territories and 529 in the states and D.C. Among all Americans, there have been 10,295 cases of Zika: 8,035 in the territories and 2,260 in the states/D.C., the CDC reported.

The number of Zika-related poor outcomes did not change during the week ending Aug. 11. The number of liveborn infants born with birth defects stayed at 16 in the states/D.C. and 1 in the territories, and the number of pregnancy losses with birth defects held at 5 in the states/D.C. and 1 in the territories, the CDC said. State- or territorial-level data are not being reported to protect the privacy of affected women and children.

The figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.

Zika virus–related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.

[email protected]

The number of pregnant women with laboratory evidence of Zika virus infection jumped by 189 during the week ending Aug. 11, with most of the increase coming in the U.S. territories, according to the Centers for Disease Control and Prevention.

The territories reported 170 new cases of Zika infection for that week, while the 50 states and the District of Columbia had 19 new cases in pregnant women. There have been 1,220 cases in pregnant women in the United States so far: 691 in the territories and 529 in the states and D.C. Among all Americans, there have been 10,295 cases of Zika: 8,035 in the territories and 2,260 in the states/D.C., the CDC reported.

The number of Zika-related poor outcomes did not change during the week ending Aug. 11. The number of liveborn infants born with birth defects stayed at 16 in the states/D.C. and 1 in the territories, and the number of pregnancy losses with birth defects held at 5 in the states/D.C. and 1 in the territories, the CDC said. State- or territorial-level data are not being reported to protect the privacy of affected women and children.

The figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.

Zika virus–related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.

[email protected]

The number of pregnant women with laboratory evidence of Zika virus infection jumped by 189 during the week ending Aug. 11, with most of the increase coming in the U.S. territories, according to the Centers for Disease Control and Prevention.

The territories reported 170 new cases of Zika infection for that week, while the 50 states and the District of Columbia had 19 new cases in pregnant women. There have been 1,220 cases in pregnant women in the United States so far: 691 in the territories and 529 in the states and D.C. Among all Americans, there have been 10,295 cases of Zika: 8,035 in the territories and 2,260 in the states/D.C., the CDC reported.

The number of Zika-related poor outcomes did not change during the week ending Aug. 11. The number of liveborn infants born with birth defects stayed at 16 in the states/D.C. and 1 in the territories, and the number of pregnancy losses with birth defects held at 5 in the states/D.C. and 1 in the territories, the CDC said. State- or territorial-level data are not being reported to protect the privacy of affected women and children.

The figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.

Zika virus–related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.

[email protected]

DURBAN, SOUTH AFRICA – Screening for anal cancer in HIV-infected men or women should not be part of routine clinical practice at this time, Andrew Grulich, MBBS, PhD, declared at the 21st International AIDS Conference.

Some experts recommend anal cytologic screening or high-resolution anoscopy for HIV-positive men and women, but it’s worth noting that strategy hasn’t been incorporated into any national practice guidelines.

Bruce Jancin/Frontline Medical News

“And for very good reason: When we have a condition with a prevalence that’s so high and a treatment with recurrence rates that are so high, I think we need to question our approach,” said Dr. Grulich, professor of medicine and head of the HIV epidemiology and prevention program at the University of New South Wales in Sydney, Australia.

Screening proponents point to the high incidence of anal cancer in persons with HIV infection. It’s the fourth most common cancer in HIV patients in the United States, behind the AIDS-defining cancers and lung cancer. Indeed, the anal cancer rate is 10-fold greater in HIV-positive women, heterosexual men, and injection drug users than in the HIV-negative general population, and 50-fold higher in HIV-positive gay and bisexual men. Screening proponents also draw an analogy between anal cancer screening and the screening and treatment of cervical intraepithelial neoplasia (CIN), which has been enormously successful in preventing cervical cancer. But Dr. Grulich said he believes the cervical cancer screening analogy is faulty.

Colposcopy has a mean 90% specificity for diagnosis of HPV-related high-grade squamous intraepithelial lesions (HSIL) or cervical cancer, while high-resolution anoscopy as a diagnostic test has a specificity as low as 37% in HIV-positive persons. The prevalence of HSIL is 30%-40% in anal samples from HIV-infected homosexual men, compared with 1%-2% in cervical samples from HIV-negative women.

The rate of progression from CIN-3 to cervical cancer in women in the general population is about 1 in 80 per year. In contrast, the rate of progression from anal intraepithelial neoplasia (AIN)-2 or AIN-3 to anal cancer in HIV-infected homosexual men is estimated at only 1 in 400-600 per year, probably because regression of anal lesions is quite common.

Moreover, while a single treatment of high-grade CIN is typically curative and entails little morbidity, destruction of AIN by means of heat, cold, or electricity has a 70% failure rate, carries substantial morbidity, and is not supported by any evidence that it actually reduces the incidence of anal cancer, he continued.

“We’re in a bit of a quandary regarding what to do about anal cancer prevention. We really need research in order to move this field forward,” Dr. Grulich said.

He added that it’s worth keeping an eye on two ongoing studies addressing key questions surrounding anal cancer in HIV-positive persons. The U.S. National Cancer Institute–funded randomized ANCHOR trial is examining ablative therapy versus watchful waiting in HIV-infected patients with anal HSIL lesions; however, results of this large study aren’t expected until 2022 or 2023. And Dr. Grulich heads the Study of the Prevention of Anal Cancer, aimed at identifying biomarkers that predict persistence of HSIL as a marker of anal cancer risk.

A study he would very much like to see funded is a randomized, placebo-controlled, adequately powered trial of the 9-valent HPV vaccine in HIV-infected gay or bisexual men over age 26. At the 2016 meeting of the Conference on Retroviruses and Opportunistic Infections (CROI), Timothy J. Wilkin, MD, of Cornell University, New York, presented the results of the phase III ACTG A5298 trial of the quadrivalent HPV vaccine in HIV-infected adults over age 26. The vaccine group had a 27% reduction in risk of persistent anal HPV compared with placebo, which wasn’t statistically significant because of the small study size. The 9-valent vaccine would prevent a broader range of oncogenic HPV types.

Dr. Grulich reported receiving research funding from CSL Australia, Gilead Sciences, Viiv, and Hologic.

[email protected]

DURBAN, SOUTH AFRICA – Screening for anal cancer in HIV-infected men or women should not be part of routine clinical practice at this time, Andrew Grulich, MBBS, PhD, declared at the 21st International AIDS Conference.

Some experts recommend anal cytologic screening or high-resolution anoscopy for HIV-positive men and women, but it’s worth noting that strategy hasn’t been incorporated into any national practice guidelines.

Bruce Jancin/Frontline Medical News

“And for very good reason: When we have a condition with a prevalence that’s so high and a treatment with recurrence rates that are so high, I think we need to question our approach,” said Dr. Grulich, professor of medicine and head of the HIV epidemiology and prevention program at the University of New South Wales in Sydney, Australia.

Screening proponents point to the high incidence of anal cancer in persons with HIV infection. It’s the fourth most common cancer in HIV patients in the United States, behind the AIDS-defining cancers and lung cancer. Indeed, the anal cancer rate is 10-fold greater in HIV-positive women, heterosexual men, and injection drug users than in the HIV-negative general population, and 50-fold higher in HIV-positive gay and bisexual men. Screening proponents also draw an analogy between anal cancer screening and the screening and treatment of cervical intraepithelial neoplasia (CIN), which has been enormously successful in preventing cervical cancer. But Dr. Grulich said he believes the cervical cancer screening analogy is faulty.

Colposcopy has a mean 90% specificity for diagnosis of HPV-related high-grade squamous intraepithelial lesions (HSIL) or cervical cancer, while high-resolution anoscopy as a diagnostic test has a specificity as low as 37% in HIV-positive persons. The prevalence of HSIL is 30%-40% in anal samples from HIV-infected homosexual men, compared with 1%-2% in cervical samples from HIV-negative women.

The rate of progression from CIN-3 to cervical cancer in women in the general population is about 1 in 80 per year. In contrast, the rate of progression from anal intraepithelial neoplasia (AIN)-2 or AIN-3 to anal cancer in HIV-infected homosexual men is estimated at only 1 in 400-600 per year, probably because regression of anal lesions is quite common.

Moreover, while a single treatment of high-grade CIN is typically curative and entails little morbidity, destruction of AIN by means of heat, cold, or electricity has a 70% failure rate, carries substantial morbidity, and is not supported by any evidence that it actually reduces the incidence of anal cancer, he continued.

“We’re in a bit of a quandary regarding what to do about anal cancer prevention. We really need research in order to move this field forward,” Dr. Grulich said.

He added that it’s worth keeping an eye on two ongoing studies addressing key questions surrounding anal cancer in HIV-positive persons. The U.S. National Cancer Institute–funded randomized ANCHOR trial is examining ablative therapy versus watchful waiting in HIV-infected patients with anal HSIL lesions; however, results of this large study aren’t expected until 2022 or 2023. And Dr. Grulich heads the Study of the Prevention of Anal Cancer, aimed at identifying biomarkers that predict persistence of HSIL as a marker of anal cancer risk.

A study he would very much like to see funded is a randomized, placebo-controlled, adequately powered trial of the 9-valent HPV vaccine in HIV-infected gay or bisexual men over age 26. At the 2016 meeting of the Conference on Retroviruses and Opportunistic Infections (CROI), Timothy J. Wilkin, MD, of Cornell University, New York, presented the results of the phase III ACTG A5298 trial of the quadrivalent HPV vaccine in HIV-infected adults over age 26. The vaccine group had a 27% reduction in risk of persistent anal HPV compared with placebo, which wasn’t statistically significant because of the small study size. The 9-valent vaccine would prevent a broader range of oncogenic HPV types.

Dr. Grulich reported receiving research funding from CSL Australia, Gilead Sciences, Viiv, and Hologic.

[email protected]

DURBAN, SOUTH AFRICA – Screening for anal cancer in HIV-infected men or women should not be part of routine clinical practice at this time, Andrew Grulich, MBBS, PhD, declared at the 21st International AIDS Conference.

Some experts recommend anal cytologic screening or high-resolution anoscopy for HIV-positive men and women, but it’s worth noting that strategy hasn’t been incorporated into any national practice guidelines.

Bruce Jancin/Frontline Medical News

“And for very good reason: When we have a condition with a prevalence that’s so high and a treatment with recurrence rates that are so high, I think we need to question our approach,” said Dr. Grulich, professor of medicine and head of the HIV epidemiology and prevention program at the University of New South Wales in Sydney, Australia.

Screening proponents point to the high incidence of anal cancer in persons with HIV infection. It’s the fourth most common cancer in HIV patients in the United States, behind the AIDS-defining cancers and lung cancer. Indeed, the anal cancer rate is 10-fold greater in HIV-positive women, heterosexual men, and injection drug users than in the HIV-negative general population, and 50-fold higher in HIV-positive gay and bisexual men. Screening proponents also draw an analogy between anal cancer screening and the screening and treatment of cervical intraepithelial neoplasia (CIN), which has been enormously successful in preventing cervical cancer. But Dr. Grulich said he believes the cervical cancer screening analogy is faulty.

Colposcopy has a mean 90% specificity for diagnosis of HPV-related high-grade squamous intraepithelial lesions (HSIL) or cervical cancer, while high-resolution anoscopy as a diagnostic test has a specificity as low as 37% in HIV-positive persons. The prevalence of HSIL is 30%-40% in anal samples from HIV-infected homosexual men, compared with 1%-2% in cervical samples from HIV-negative women.

The rate of progression from CIN-3 to cervical cancer in women in the general population is about 1 in 80 per year. In contrast, the rate of progression from anal intraepithelial neoplasia (AIN)-2 or AIN-3 to anal cancer in HIV-infected homosexual men is estimated at only 1 in 400-600 per year, probably because regression of anal lesions is quite common.

Moreover, while a single treatment of high-grade CIN is typically curative and entails little morbidity, destruction of AIN by means of heat, cold, or electricity has a 70% failure rate, carries substantial morbidity, and is not supported by any evidence that it actually reduces the incidence of anal cancer, he continued.

“We’re in a bit of a quandary regarding what to do about anal cancer prevention. We really need research in order to move this field forward,” Dr. Grulich said.

He added that it’s worth keeping an eye on two ongoing studies addressing key questions surrounding anal cancer in HIV-positive persons. The U.S. National Cancer Institute–funded randomized ANCHOR trial is examining ablative therapy versus watchful waiting in HIV-infected patients with anal HSIL lesions; however, results of this large study aren’t expected until 2022 or 2023. And Dr. Grulich heads the Study of the Prevention of Anal Cancer, aimed at identifying biomarkers that predict persistence of HSIL as a marker of anal cancer risk.

A study he would very much like to see funded is a randomized, placebo-controlled, adequately powered trial of the 9-valent HPV vaccine in HIV-infected gay or bisexual men over age 26. At the 2016 meeting of the Conference on Retroviruses and Opportunistic Infections (CROI), Timothy J. Wilkin, MD, of Cornell University, New York, presented the results of the phase III ACTG A5298 trial of the quadrivalent HPV vaccine in HIV-infected adults over age 26. The vaccine group had a 27% reduction in risk of persistent anal HPV compared with placebo, which wasn’t statistically significant because of the small study size. The 9-valent vaccine would prevent a broader range of oncogenic HPV types.

Dr. Grulich reported receiving research funding from CSL Australia, Gilead Sciences, Viiv, and Hologic.

[email protected]

 

 

Follicular lymphoma

 

Results of the phase 3 GADOLIN trial have revealed a new treatment option for patients with relapsed/refractory non-Hodgkin lymphoma (NHL), according to researchers.

The trial showed that obinutuzumab plus bendamustine, followed by obinutuzumab maintenance, can ward off disease progression in NHL patients who have relapsed after rituximab-based

therapy or stopped responding to it.

The obinutuzumab regimen significantly improved progression-free survival (PFS) when compared to bendamustine alone (without maintenance).

However, there was no significant difference between the 2 treatment arms with regard to overall survival (OS).

Still, the trial was stopped before its protocol-specified final analysis because of the PFS benefit in the obinutuzumab arm.

Laurie Sehn, MD, of the BC Cancer Agency in Vancouver, British Columbia, Canada, and her colleagues reported the results of this trial in The Lancet. The research was funded by F. Hoffmann-La Roche Ltd.

Patients and treatment

GADOLIN enrolled patients with relapsed/refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), and Waldenstrom’s macroglobulinemia (WM).

The patients were randomized to receive one of the following treatments:

• bendamustine alone (120 mg/m²/day on days 1 and 2 for up to six 28-day cycles)
• bendamustine (90 mg/m²/day on days 1 and 2 for up to six 28-day cycles) plus obinutuzumab (1000 mg on days 1, 8, and 15 for cycle 1, followed by 1 dose for up to six 28-day cycles), followed by obinutuzumab maintenance (1000 mg every 2 months for 2 years or until progression).

The investigators said baseline characteristics were well-balanced between the treatment arms. Patients in both arms had received a median of 2 prior treatments, and the median time from last treatment was about 4 months.

Of the 194 patients randomized to the obinutuzumab arm, 155 had FL, 27 had MZL, and 12 had SLL. Of the 202 patients randomized to the bendamustine (control) arm, 166 had FL, 19 had MZL, 16 had SLL, and 1 had WM.

Ultimately, 156 patients completed induction in the obinutuzumab arm, as did 129 patients in the control arm. Thirty-six patients completed maintenance with obinutuzumab, and 46 were still receiving maintenance at the time of analysis.

The median follow-up was 21.9 months in the obinutuzumab arm and 20.3 months in the control arm.

Safety

Nearly all patients in both arms experienced at least 1 adverse event (AE).

Grade 3-5 AEs occurred in 68% of patients in the obinutuzumab arm and 62% in the control arm. The most frequent of these were neutropenia (33% vs 26%), thrombocytopenia (11% vs 16%), anemia (8% vs 10%), and infusion-related reactions (11% vs 6%).

Serious AEs occurred in 38% of patients in the obinutuzumab arm and 33% in the control arm. The most common were febrile neutropenia (4% vs 3%), infusion-related reactions (4% vs 2%), and pneumonia (3% vs 5%).

Response

According to an independent review committee, the overall response rate at the end of induction was 69% in the obinutuzumab arm and 63% in the control arm. The complete response rates were 11% and 12%, respectively.

The median duration of response was not reached in the obinutuzumab arm and was 13.2 months in the control arm.

Survival

The median PFS was not reached in the obinutuzumab arm and was 14.9 months in the control arm (P=0.0001), according to the independent review committee.

According to investigators, the median PFS was 29.2 months and 14 months, respectively (P<0.0001).

At last follow-up, the median OS had not been reached in either arm (P=0.40).

There were 34 deaths in the obinutuzumab arm and 41 in the control arm (18% and 20%, respectively). Most patients died of disease progression (65% and 71%, respectively).

Twelve patients in each arm (6%) died of AEs. Three of these deaths were treatment-related in the obinutuzumab arm (acute myeloid leukemia, vascular pseudoaneurysm, and pseudomonal sepsis).

Five of the 12 AE deaths in the control arm were treatment-related (sepsis, 2 cases of leukemia, and 2 cases of Pneumocystis jirovecii pneumonia).

Taking these results together, the investigators said the obinutuzumab regimen had a manageable toxicity profile, and it produced a “clinically meaningful and significant” improvement in PFS when compared to bendamustine alone.

 

 

Follicular lymphoma

 

Results of the phase 3 GADOLIN trial have revealed a new treatment option for patients with relapsed/refractory non-Hodgkin lymphoma (NHL), according to researchers.

The trial showed that obinutuzumab plus bendamustine, followed by obinutuzumab maintenance, can ward off disease progression in NHL patients who have relapsed after rituximab-based

therapy or stopped responding to it.

The obinutuzumab regimen significantly improved progression-free survival (PFS) when compared to bendamustine alone (without maintenance).

However, there was no significant difference between the 2 treatment arms with regard to overall survival (OS).

Still, the trial was stopped before its protocol-specified final analysis because of the PFS benefit in the obinutuzumab arm.

Laurie Sehn, MD, of the BC Cancer Agency in Vancouver, British Columbia, Canada, and her colleagues reported the results of this trial in The Lancet. The research was funded by F. Hoffmann-La Roche Ltd.

Patients and treatment

GADOLIN enrolled patients with relapsed/refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), and Waldenstrom’s macroglobulinemia (WM).

The patients were randomized to receive one of the following treatments:

• bendamustine alone (120 mg/m²/day on days 1 and 2 for up to six 28-day cycles)
• bendamustine (90 mg/m²/day on days 1 and 2 for up to six 28-day cycles) plus obinutuzumab (1000 mg on days 1, 8, and 15 for cycle 1, followed by 1 dose for up to six 28-day cycles), followed by obinutuzumab maintenance (1000 mg every 2 months for 2 years or until progression).

The investigators said baseline characteristics were well-balanced between the treatment arms. Patients in both arms had received a median of 2 prior treatments, and the median time from last treatment was about 4 months.

Of the 194 patients randomized to the obinutuzumab arm, 155 had FL, 27 had MZL, and 12 had SLL. Of the 202 patients randomized to the bendamustine (control) arm, 166 had FL, 19 had MZL, 16 had SLL, and 1 had WM.

Ultimately, 156 patients completed induction in the obinutuzumab arm, as did 129 patients in the control arm. Thirty-six patients completed maintenance with obinutuzumab, and 46 were still receiving maintenance at the time of analysis.

The median follow-up was 21.9 months in the obinutuzumab arm and 20.3 months in the control arm.

Safety

Nearly all patients in both arms experienced at least 1 adverse event (AE).

Grade 3-5 AEs occurred in 68% of patients in the obinutuzumab arm and 62% in the control arm. The most frequent of these were neutropenia (33% vs 26%), thrombocytopenia (11% vs 16%), anemia (8% vs 10%), and infusion-related reactions (11% vs 6%).

Serious AEs occurred in 38% of patients in the obinutuzumab arm and 33% in the control arm. The most common were febrile neutropenia (4% vs 3%), infusion-related reactions (4% vs 2%), and pneumonia (3% vs 5%).

Response

According to an independent review committee, the overall response rate at the end of induction was 69% in the obinutuzumab arm and 63% in the control arm. The complete response rates were 11% and 12%, respectively.

The median duration of response was not reached in the obinutuzumab arm and was 13.2 months in the control arm.

Survival

The median PFS was not reached in the obinutuzumab arm and was 14.9 months in the control arm (P=0.0001), according to the independent review committee.

According to investigators, the median PFS was 29.2 months and 14 months, respectively (P<0.0001).

At last follow-up, the median OS had not been reached in either arm (P=0.40).

There were 34 deaths in the obinutuzumab arm and 41 in the control arm (18% and 20%, respectively). Most patients died of disease progression (65% and 71%, respectively).

Twelve patients in each arm (6%) died of AEs. Three of these deaths were treatment-related in the obinutuzumab arm (acute myeloid leukemia, vascular pseudoaneurysm, and pseudomonal sepsis).

Five of the 12 AE deaths in the control arm were treatment-related (sepsis, 2 cases of leukemia, and 2 cases of Pneumocystis jirovecii pneumonia).

Taking these results together, the investigators said the obinutuzumab regimen had a manageable toxicity profile, and it produced a “clinically meaningful and significant” improvement in PFS when compared to bendamustine alone.

 

 

Follicular lymphoma

 

Results of the phase 3 GADOLIN trial have revealed a new treatment option for patients with relapsed/refractory non-Hodgkin lymphoma (NHL), according to researchers.

The trial showed that obinutuzumab plus bendamustine, followed by obinutuzumab maintenance, can ward off disease progression in NHL patients who have relapsed after rituximab-based

therapy or stopped responding to it.

The obinutuzumab regimen significantly improved progression-free survival (PFS) when compared to bendamustine alone (without maintenance).

However, there was no significant difference between the 2 treatment arms with regard to overall survival (OS).

Still, the trial was stopped before its protocol-specified final analysis because of the PFS benefit in the obinutuzumab arm.

Laurie Sehn, MD, of the BC Cancer Agency in Vancouver, British Columbia, Canada, and her colleagues reported the results of this trial in The Lancet. The research was funded by F. Hoffmann-La Roche Ltd.

Patients and treatment

GADOLIN enrolled patients with relapsed/refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), and Waldenstrom’s macroglobulinemia (WM).

The patients were randomized to receive one of the following treatments:

• bendamustine alone (120 mg/m²/day on days 1 and 2 for up to six 28-day cycles)
• bendamustine (90 mg/m²/day on days 1 and 2 for up to six 28-day cycles) plus obinutuzumab (1000 mg on days 1, 8, and 15 for cycle 1, followed by 1 dose for up to six 28-day cycles), followed by obinutuzumab maintenance (1000 mg every 2 months for 2 years or until progression).

The investigators said baseline characteristics were well-balanced between the treatment arms. Patients in both arms had received a median of 2 prior treatments, and the median time from last treatment was about 4 months.

Of the 194 patients randomized to the obinutuzumab arm, 155 had FL, 27 had MZL, and 12 had SLL. Of the 202 patients randomized to the bendamustine (control) arm, 166 had FL, 19 had MZL, 16 had SLL, and 1 had WM.

Ultimately, 156 patients completed induction in the obinutuzumab arm, as did 129 patients in the control arm. Thirty-six patients completed maintenance with obinutuzumab, and 46 were still receiving maintenance at the time of analysis.

The median follow-up was 21.9 months in the obinutuzumab arm and 20.3 months in the control arm.

Safety

Nearly all patients in both arms experienced at least 1 adverse event (AE).

Grade 3-5 AEs occurred in 68% of patients in the obinutuzumab arm and 62% in the control arm. The most frequent of these were neutropenia (33% vs 26%), thrombocytopenia (11% vs 16%), anemia (8% vs 10%), and infusion-related reactions (11% vs 6%).

Serious AEs occurred in 38% of patients in the obinutuzumab arm and 33% in the control arm. The most common were febrile neutropenia (4% vs 3%), infusion-related reactions (4% vs 2%), and pneumonia (3% vs 5%).

Response

According to an independent review committee, the overall response rate at the end of induction was 69% in the obinutuzumab arm and 63% in the control arm. The complete response rates were 11% and 12%, respectively.

The median duration of response was not reached in the obinutuzumab arm and was 13.2 months in the control arm.

Survival

The median PFS was not reached in the obinutuzumab arm and was 14.9 months in the control arm (P=0.0001), according to the independent review committee.

According to investigators, the median PFS was 29.2 months and 14 months, respectively (P<0.0001).

At last follow-up, the median OS had not been reached in either arm (P=0.40).

There were 34 deaths in the obinutuzumab arm and 41 in the control arm (18% and 20%, respectively). Most patients died of disease progression (65% and 71%, respectively).

Twelve patients in each arm (6%) died of AEs. Three of these deaths were treatment-related in the obinutuzumab arm (acute myeloid leukemia, vascular pseudoaneurysm, and pseudomonal sepsis).

Five of the 12 AE deaths in the control arm were treatment-related (sepsis, 2 cases of leukemia, and 2 cases of Pneumocystis jirovecii pneumonia).

Taking these results together, the investigators said the obinutuzumab regimen had a manageable toxicity profile, and it produced a “clinically meaningful and significant” improvement in PFS when compared to bendamustine alone.

Apixaban (Eliquis)

Photo courtesy of Pfizer

and Bristol-Myers Squibb

The US Food and Drug Administration (FDA) has issued a complete response letter regarding the biologics license application for andexanet alfa (AndexXa™).

Andexanet alfa is being developed as a reversal agent for the factor Xa inhibitors apixaban, rivaroxaban, edoxaban, and enoxaparin.

The agent is intended to be used when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

In the complete response letter, the FDA requested that Portola Pharmaceuticals Inc., the company developing andexanet alfa, provide additional information related to manufacturing.

Portola said it could not provide many details on this request but stressed that the FDA did not question the company’s ability to manufacture the drug.

The FDA also asked Portola for additional data to support the inclusion of edoxaban and enoxaparin on andexanet alfa’s label.

The completed phase 3 studies of andexanet alfa were designed to assess the drug’s ability to reverse the effects of apixaban and rivaroxaban—but not edoxaban or enoxaparin—in healthy volunteers. Andexanet alfa’s effects on edoxaban and enoxaparin have been investigated in phase 2 studies, however.

Portola had assumed these studies would be sufficient because, overall, the research suggests andexanet alfa has broad activity against factor Xa inhibitors, according to Bill Lis, chief executive officer of Portola.

Lis also noted that the primary use of andexanet alfa, once approved, would be in patients receiving rivaroxaban or apixaban because fewer patients take edoxaban and enoxaparin.

The final issue the FDA mentioned in the complete response letter was the need to finalize its review of the clinical amendments to Portola’s post-marketing commitments.

“Because AndexXa addresses an urgent unmet medical need, we and the FDA are committed to resolving the outstanding questions and determining appropriate next steps,” Lis said.

“Portola’s goal is to define the most expedient path to approval so we can meet the needs of these patients who have no alternative. We plan to meet with the FDA as soon as possible.”

About andexanet alfa

Andexanet alfa is a modified human factor Xa molecule that acts as a decoy to target and sequester both oral and injectable factor Xa inhibitors in the blood. Once bound, the factor Xa inhibitors are unable to bind to and inhibit native factor Xa, thus potentially allowing for the restoration of normal hemostatic processes.

The FDA granted andexanet alfa orphan drug designation last year and breakthrough therapy designation in 2013.

Portola’s biologics license application for andexanet alfa was based on data from a pair of phase 3 studies of healthy volunteers—ANNEXA-A and ANNEXA-R.

In the ANNEXA-R trial, andexanet alfa successfully reversed the anticoagulant activity of rivaroxaban. In the ANNEXA-A trial, andexanet alfa reversed the anticoagulant activity of apixaban.

Results from these studies were published in NEJM last year.

The biologics license application also included limited adjudicated efficacy and safety data from initial patients enrolled in the ongoing ANNEXA-4 study.

In this phase 3b/4 study, researchers are evaluating andexanet alfa in patients receiving apixaban, rivaroxaban, edoxaban, or enoxaparin who present with an acute major bleed.

Apixaban (Eliquis)

Photo courtesy of Pfizer

and Bristol-Myers Squibb

The US Food and Drug Administration (FDA) has issued a complete response letter regarding the biologics license application for andexanet alfa (AndexXa™).

Andexanet alfa is being developed as a reversal agent for the factor Xa inhibitors apixaban, rivaroxaban, edoxaban, and enoxaparin.

The agent is intended to be used when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

In the complete response letter, the FDA requested that Portola Pharmaceuticals Inc., the company developing andexanet alfa, provide additional information related to manufacturing.

Portola said it could not provide many details on this request but stressed that the FDA did not question the company’s ability to manufacture the drug.

The FDA also asked Portola for additional data to support the inclusion of edoxaban and enoxaparin on andexanet alfa’s label.

The completed phase 3 studies of andexanet alfa were designed to assess the drug’s ability to reverse the effects of apixaban and rivaroxaban—but not edoxaban or enoxaparin—in healthy volunteers. Andexanet alfa’s effects on edoxaban and enoxaparin have been investigated in phase 2 studies, however.

Portola had assumed these studies would be sufficient because, overall, the research suggests andexanet alfa has broad activity against factor Xa inhibitors, according to Bill Lis, chief executive officer of Portola.

Lis also noted that the primary use of andexanet alfa, once approved, would be in patients receiving rivaroxaban or apixaban because fewer patients take edoxaban and enoxaparin.

The final issue the FDA mentioned in the complete response letter was the need to finalize its review of the clinical amendments to Portola’s post-marketing commitments.

“Because AndexXa addresses an urgent unmet medical need, we and the FDA are committed to resolving the outstanding questions and determining appropriate next steps,” Lis said.

“Portola’s goal is to define the most expedient path to approval so we can meet the needs of these patients who have no alternative. We plan to meet with the FDA as soon as possible.”

About andexanet alfa

Andexanet alfa is a modified human factor Xa molecule that acts as a decoy to target and sequester both oral and injectable factor Xa inhibitors in the blood. Once bound, the factor Xa inhibitors are unable to bind to and inhibit native factor Xa, thus potentially allowing for the restoration of normal hemostatic processes.

The FDA granted andexanet alfa orphan drug designation last year and breakthrough therapy designation in 2013.

Portola’s biologics license application for andexanet alfa was based on data from a pair of phase 3 studies of healthy volunteers—ANNEXA-A and ANNEXA-R.

In the ANNEXA-R trial, andexanet alfa successfully reversed the anticoagulant activity of rivaroxaban. In the ANNEXA-A trial, andexanet alfa reversed the anticoagulant activity of apixaban.

Results from these studies were published in NEJM last year.

The biologics license application also included limited adjudicated efficacy and safety data from initial patients enrolled in the ongoing ANNEXA-4 study.

In this phase 3b/4 study, researchers are evaluating andexanet alfa in patients receiving apixaban, rivaroxaban, edoxaban, or enoxaparin who present with an acute major bleed.

Apixaban (Eliquis)

Photo courtesy of Pfizer

and Bristol-Myers Squibb

The US Food and Drug Administration (FDA) has issued a complete response letter regarding the biologics license application for andexanet alfa (AndexXa™).

Andexanet alfa is being developed as a reversal agent for the factor Xa inhibitors apixaban, rivaroxaban, edoxaban, and enoxaparin.

The agent is intended to be used when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

In the complete response letter, the FDA requested that Portola Pharmaceuticals Inc., the company developing andexanet alfa, provide additional information related to manufacturing.

Portola said it could not provide many details on this request but stressed that the FDA did not question the company’s ability to manufacture the drug.

The FDA also asked Portola for additional data to support the inclusion of edoxaban and enoxaparin on andexanet alfa’s label.

The completed phase 3 studies of andexanet alfa were designed to assess the drug’s ability to reverse the effects of apixaban and rivaroxaban—but not edoxaban or enoxaparin—in healthy volunteers. Andexanet alfa’s effects on edoxaban and enoxaparin have been investigated in phase 2 studies, however.

Portola had assumed these studies would be sufficient because, overall, the research suggests andexanet alfa has broad activity against factor Xa inhibitors, according to Bill Lis, chief executive officer of Portola.

Lis also noted that the primary use of andexanet alfa, once approved, would be in patients receiving rivaroxaban or apixaban because fewer patients take edoxaban and enoxaparin.

The final issue the FDA mentioned in the complete response letter was the need to finalize its review of the clinical amendments to Portola’s post-marketing commitments.

“Because AndexXa addresses an urgent unmet medical need, we and the FDA are committed to resolving the outstanding questions and determining appropriate next steps,” Lis said.

“Portola’s goal is to define the most expedient path to approval so we can meet the needs of these patients who have no alternative. We plan to meet with the FDA as soon as possible.”

About andexanet alfa

Andexanet alfa is a modified human factor Xa molecule that acts as a decoy to target and sequester both oral and injectable factor Xa inhibitors in the blood. Once bound, the factor Xa inhibitors are unable to bind to and inhibit native factor Xa, thus potentially allowing for the restoration of normal hemostatic processes.

The FDA granted andexanet alfa orphan drug designation last year and breakthrough therapy designation in 2013.

Portola’s biologics license application for andexanet alfa was based on data from a pair of phase 3 studies of healthy volunteers—ANNEXA-A and ANNEXA-R.

In the ANNEXA-R trial, andexanet alfa successfully reversed the anticoagulant activity of rivaroxaban. In the ANNEXA-A trial, andexanet alfa reversed the anticoagulant activity of apixaban.

Results from these studies were published in NEJM last year.

The biologics license application also included limited adjudicated efficacy and safety data from initial patients enrolled in the ongoing ANNEXA-4 study.

In this phase 3b/4 study, researchers are evaluating andexanet alfa in patients receiving apixaban, rivaroxaban, edoxaban, or enoxaparin who present with an acute major bleed.

Diffuse large B-cell lymphoma

The histone deacetylase inhibitor panobinostat can produce durable responses in certain patients with relapsed diffuse large B-cell lymphoma (DLBCL), according to a phase 2 trial.

Though less than 30% of the patients in this trial responded to treatment, the median duration of response was 14.5 months, and the longest ongoing response has lasted more than 3.5 years.

In addition, researchers found the presence of mutations in MEF2B and levels of circulating tumor DNA (ctDNA) could be used to predict response.

Sarit Assouline, MD, of Jewish General Hospital in Montreal, Quebec, Canada, and her colleagues reported these findings in Blood.

“DLBCL is one of the more common forms of lymphoma and is highly aggressive,” Dr Assouline noted. “Following relapse, there are no effective standards of treatment, and life expectancy averages 6 months.”

“Our challenge is to identify new biomarkers and target specific mutations in order to improve the prognosis. While many clinical trials simply report on how patients respond to a therapy, we devised this study to reveal the mechanisms on which the therapy works in order to understand which patients would benefit.”

The trial enrolled 40 patients with relapsed or refractory de novo (n=27) or transformed (n=13) DLBCL. The patients’ median age was 59.8 (range, 28.9-78.6). They received a median of 3 prior therapies (range, 1-9), and 75% of patients (n=30) were refractory to their most recent therapy.

The patients received panobinostat at 30 mg three times a week, with rituximab (n=19) or without (n=21).

Adverse events

The most common grade 3 or higher adverse events (AEs) that were thought to be related to panobinostat (with and without rituximab, respectively) were thrombocytopenia (68% and 71%) and neutropenia (11% and 24%).

Twenty-three patients (58%) required dose reductions, and 22 (55%) required dose interruptions. All of these were due to AEs, and there was no difference between patients who received rituximab and those who did not.

All 19 serious AEs were a result of disease progression.

Response

Twenty-eight percent of the patients (11/40) responded to treatment, and receiving rituximab did not increase the likelihood of response. Six patients (29%) responded to panobinostat alone, and 5 (26%) responded to panobinostat and rituximab.

There were 7 complete responses—5 of them among patients who received panobinostat alone. And there were 4 partial responses—3 among the patients who received panobinostat plus rituximab.

The median duration of response was 14.5 months overall, 9.4 months among patients who received panobinostat plus rituximab, and it was not reached among patients who received panobinostat alone.

At the data cutoff, 6 of the 11 responders had not progressed. The longest response had lasted more than 43 months and was ongoing at the cutoff point.

Predicting response

The researchers performed genome and exome sequencing in relapsed tumor biopsies and quantified ctDNA in serial plasma samples.

They found that mutations in MEF2B were significantly associated with response to panobinostat. The likelihood ratio for response was 3.67 for patients with MEF2B mutations.

On the other hand, increased levels of ctDNA were strongly associated with treatment failure. A significant increase in ctDNA at day 15 after treatment initiation could predict a lack of response with a sensitivity of 71.4% and a specificity of 100%.

“This trial has generated considerable data regarding methodology for processing samples from a clinical study, the genetic mutations associated with DLBCL and how they evolve over time, on ctDNA, and mechanisms of resistance to histone deacetylase inhibitors,” Dr Assouline concluded.

Novartis provided panobinostat and financial support for this trial, and Hoffman-LaRoche supplied rituximab.

Diffuse large B-cell lymphoma

The histone deacetylase inhibitor panobinostat can produce durable responses in certain patients with relapsed diffuse large B-cell lymphoma (DLBCL), according to a phase 2 trial.

Though less than 30% of the patients in this trial responded to treatment, the median duration of response was 14.5 months, and the longest ongoing response has lasted more than 3.5 years.

In addition, researchers found the presence of mutations in MEF2B and levels of circulating tumor DNA (ctDNA) could be used to predict response.

Sarit Assouline, MD, of Jewish General Hospital in Montreal, Quebec, Canada, and her colleagues reported these findings in Blood.

“DLBCL is one of the more common forms of lymphoma and is highly aggressive,” Dr Assouline noted. “Following relapse, there are no effective standards of treatment, and life expectancy averages 6 months.”

“Our challenge is to identify new biomarkers and target specific mutations in order to improve the prognosis. While many clinical trials simply report on how patients respond to a therapy, we devised this study to reveal the mechanisms on which the therapy works in order to understand which patients would benefit.”

The trial enrolled 40 patients with relapsed or refractory de novo (n=27) or transformed (n=13) DLBCL. The patients’ median age was 59.8 (range, 28.9-78.6). They received a median of 3 prior therapies (range, 1-9), and 75% of patients (n=30) were refractory to their most recent therapy.

The patients received panobinostat at 30 mg three times a week, with rituximab (n=19) or without (n=21).

Adverse events

The most common grade 3 or higher adverse events (AEs) that were thought to be related to panobinostat (with and without rituximab, respectively) were thrombocytopenia (68% and 71%) and neutropenia (11% and 24%).

Twenty-three patients (58%) required dose reductions, and 22 (55%) required dose interruptions. All of these were due to AEs, and there was no difference between patients who received rituximab and those who did not.

All 19 serious AEs were a result of disease progression.

Response

Twenty-eight percent of the patients (11/40) responded to treatment, and receiving rituximab did not increase the likelihood of response. Six patients (29%) responded to panobinostat alone, and 5 (26%) responded to panobinostat and rituximab.

There were 7 complete responses—5 of them among patients who received panobinostat alone. And there were 4 partial responses—3 among the patients who received panobinostat plus rituximab.

The median duration of response was 14.5 months overall, 9.4 months among patients who received panobinostat plus rituximab, and it was not reached among patients who received panobinostat alone.

At the data cutoff, 6 of the 11 responders had not progressed. The longest response had lasted more than 43 months and was ongoing at the cutoff point.

Predicting response

The researchers performed genome and exome sequencing in relapsed tumor biopsies and quantified ctDNA in serial plasma samples.

They found that mutations in MEF2B were significantly associated with response to panobinostat. The likelihood ratio for response was 3.67 for patients with MEF2B mutations.

On the other hand, increased levels of ctDNA were strongly associated with treatment failure. A significant increase in ctDNA at day 15 after treatment initiation could predict a lack of response with a sensitivity of 71.4% and a specificity of 100%.

“This trial has generated considerable data regarding methodology for processing samples from a clinical study, the genetic mutations associated with DLBCL and how they evolve over time, on ctDNA, and mechanisms of resistance to histone deacetylase inhibitors,” Dr Assouline concluded.

Novartis provided panobinostat and financial support for this trial, and Hoffman-LaRoche supplied rituximab.

Diffuse large B-cell lymphoma

The histone deacetylase inhibitor panobinostat can produce durable responses in certain patients with relapsed diffuse large B-cell lymphoma (DLBCL), according to a phase 2 trial.

Though less than 30% of the patients in this trial responded to treatment, the median duration of response was 14.5 months, and the longest ongoing response has lasted more than 3.5 years.

In addition, researchers found the presence of mutations in MEF2B and levels of circulating tumor DNA (ctDNA) could be used to predict response.

Sarit Assouline, MD, of Jewish General Hospital in Montreal, Quebec, Canada, and her colleagues reported these findings in Blood.

“DLBCL is one of the more common forms of lymphoma and is highly aggressive,” Dr Assouline noted. “Following relapse, there are no effective standards of treatment, and life expectancy averages 6 months.”

“Our challenge is to identify new biomarkers and target specific mutations in order to improve the prognosis. While many clinical trials simply report on how patients respond to a therapy, we devised this study to reveal the mechanisms on which the therapy works in order to understand which patients would benefit.”

The trial enrolled 40 patients with relapsed or refractory de novo (n=27) or transformed (n=13) DLBCL. The patients’ median age was 59.8 (range, 28.9-78.6). They received a median of 3 prior therapies (range, 1-9), and 75% of patients (n=30) were refractory to their most recent therapy.

The patients received panobinostat at 30 mg three times a week, with rituximab (n=19) or without (n=21).

Adverse events

The most common grade 3 or higher adverse events (AEs) that were thought to be related to panobinostat (with and without rituximab, respectively) were thrombocytopenia (68% and 71%) and neutropenia (11% and 24%).

Twenty-three patients (58%) required dose reductions, and 22 (55%) required dose interruptions. All of these were due to AEs, and there was no difference between patients who received rituximab and those who did not.

All 19 serious AEs were a result of disease progression.

Response

Twenty-eight percent of the patients (11/40) responded to treatment, and receiving rituximab did not increase the likelihood of response. Six patients (29%) responded to panobinostat alone, and 5 (26%) responded to panobinostat and rituximab.

There were 7 complete responses—5 of them among patients who received panobinostat alone. And there were 4 partial responses—3 among the patients who received panobinostat plus rituximab.

The median duration of response was 14.5 months overall, 9.4 months among patients who received panobinostat plus rituximab, and it was not reached among patients who received panobinostat alone.

At the data cutoff, 6 of the 11 responders had not progressed. The longest response had lasted more than 43 months and was ongoing at the cutoff point.

Predicting response

The researchers performed genome and exome sequencing in relapsed tumor biopsies and quantified ctDNA in serial plasma samples.

They found that mutations in MEF2B were significantly associated with response to panobinostat. The likelihood ratio for response was 3.67 for patients with MEF2B mutations.

On the other hand, increased levels of ctDNA were strongly associated with treatment failure. A significant increase in ctDNA at day 15 after treatment initiation could predict a lack of response with a sensitivity of 71.4% and a specificity of 100%.

“This trial has generated considerable data regarding methodology for processing samples from a clinical study, the genetic mutations associated with DLBCL and how they evolve over time, on ctDNA, and mechanisms of resistance to histone deacetylase inhibitors,” Dr Assouline concluded.

Novartis provided panobinostat and financial support for this trial, and Hoffman-LaRoche supplied rituximab.

Background: The Centers for Medicare & Medicaid Services (CMS) tracks 30-day all-cause readmission rates as a quality measure. Prior studies have looked at various hospital factors associated with lower readmission rates but have not looked at hospitalist staffing levels, level of physician integration with the hospital, and the adoption of a medical home model.

Study design: Retrospective cohort study.

Setting: Private hospitals.

Synopsis: Using the American Hospital Association Annual Survey of Hospitals, CMS Hospital Compare, and Area Health Resources File of private hospitals with no missing data, the study reviewed data from 1,756 hospitals and found the median 30-day all-cause readmission rate to be 16%, with the middle 50% of hospitals’ readmission rate between 15.2% and 16.5%. All hospitals used hospitalists to provide care. Fifty-one percent of hospitals reported fully integrated, or employed, physicians. Twenty-nine percent reported establishment of a medical home.

The study found that higher hospitalist staffing levels were associated with significantly lower readmission rates. Fully integrated hospitals had a lower readmission rate than not fully integrated (15.86% versus 15.93%). Also, physician-owned hospitals had a lower readmission rate than non-physician-owned hospitals, and hospitals that had adopted a medical home model had significantly lower readmission rates. Readmission rates were significantly higher for major teaching hospitals (16.9% versus 15.76% minor teaching versus 15.83% nonteaching).

Bottom line: High hospitalist staffing levels, full integration of the hospitalists, and physician-owned hospitals were associated with lower 30-day all-cause readmission rates for private hospitals.

Citation: Al-Amin M. Hospital characteristics and 30-day all-cause readmission rates [published online ahead of print May 17, 2016]. J Hosp Med. doi:10.1002/jhm.2606

Background: The Centers for Medicare & Medicaid Services (CMS) tracks 30-day all-cause readmission rates as a quality measure. Prior studies have looked at various hospital factors associated with lower readmission rates but have not looked at hospitalist staffing levels, level of physician integration with the hospital, and the adoption of a medical home model.

Study design: Retrospective cohort study.

Setting: Private hospitals.

Synopsis: Using the American Hospital Association Annual Survey of Hospitals, CMS Hospital Compare, and Area Health Resources File of private hospitals with no missing data, the study reviewed data from 1,756 hospitals and found the median 30-day all-cause readmission rate to be 16%, with the middle 50% of hospitals’ readmission rate between 15.2% and 16.5%. All hospitals used hospitalists to provide care. Fifty-one percent of hospitals reported fully integrated, or employed, physicians. Twenty-nine percent reported establishment of a medical home.

The study found that higher hospitalist staffing levels were associated with significantly lower readmission rates. Fully integrated hospitals had a lower readmission rate than not fully integrated (15.86% versus 15.93%). Also, physician-owned hospitals had a lower readmission rate than non-physician-owned hospitals, and hospitals that had adopted a medical home model had significantly lower readmission rates. Readmission rates were significantly higher for major teaching hospitals (16.9% versus 15.76% minor teaching versus 15.83% nonteaching).

Bottom line: High hospitalist staffing levels, full integration of the hospitalists, and physician-owned hospitals were associated with lower 30-day all-cause readmission rates for private hospitals.

Citation: Al-Amin M. Hospital characteristics and 30-day all-cause readmission rates [published online ahead of print May 17, 2016]. J Hosp Med. doi:10.1002/jhm.2606

Background: The Centers for Medicare & Medicaid Services (CMS) tracks 30-day all-cause readmission rates as a quality measure. Prior studies have looked at various hospital factors associated with lower readmission rates but have not looked at hospitalist staffing levels, level of physician integration with the hospital, and the adoption of a medical home model.

Study design: Retrospective cohort study.

Setting: Private hospitals.

Synopsis: Using the American Hospital Association Annual Survey of Hospitals, CMS Hospital Compare, and Area Health Resources File of private hospitals with no missing data, the study reviewed data from 1,756 hospitals and found the median 30-day all-cause readmission rate to be 16%, with the middle 50% of hospitals’ readmission rate between 15.2% and 16.5%. All hospitals used hospitalists to provide care. Fifty-one percent of hospitals reported fully integrated, or employed, physicians. Twenty-nine percent reported establishment of a medical home.

The study found that higher hospitalist staffing levels were associated with significantly lower readmission rates. Fully integrated hospitals had a lower readmission rate than not fully integrated (15.86% versus 15.93%). Also, physician-owned hospitals had a lower readmission rate than non-physician-owned hospitals, and hospitals that had adopted a medical home model had significantly lower readmission rates. Readmission rates were significantly higher for major teaching hospitals (16.9% versus 15.76% minor teaching versus 15.83% nonteaching).

Bottom line: High hospitalist staffing levels, full integration of the hospitalists, and physician-owned hospitals were associated with lower 30-day all-cause readmission rates for private hospitals.

Citation: Al-Amin M. Hospital characteristics and 30-day all-cause readmission rates [published online ahead of print May 17, 2016]. J Hosp Med. doi:10.1002/jhm.2606

Background: Treating infective endocarditis with four to six weeks of intravenous antibiotics carries a high cost. There are data to support oral antibiotics for right-sided endocarditis due to methicillin-sensitive Staphylococcus aureus (with ciprofloxacin and rifampicin), but experience in using oral antibiotics for infective endocarditis is limited.

Study design: Cohort study.

Setting: Large academic hospital in France.

Synopsis: The researchers included 426 patients with definitive or probable endocarditis by Duke criteria. After an initial period of treatment with intravenous (IV) antibiotics, 50% of the identified group was transitioned to oral antibiotics (amoxicillin alone in 50% and combinations of fluoroquinolones, rifampicin, amoxicillin, and clindamycin in the others).

The risk of death was not increased in the group treated with oral antibiotics when adjusted for the four biggest predictors of death (age >65, type 1 diabetes mellitus, disinsertion of prosthetic valve, and endocarditis due to S. aureus). Nine patients treated with IV antibiotics experienced relapsed endocarditis compared to two patients treated with oral antibiotics.

Patients selected for treatment with oral antibiotics were less likely to have severe disease, significant comorbidities, or infection with S. aureus. The length of treatment with IV antibiotics before switching to oral antibiotics varied widely.

Bottom line: It’s possible low-risk patients with infective endocarditis may be treated with oral antibiotics, but more data are needed.

Citation: Mzabi A, Kernéis S, Richaud C, Podglajen I, Fernandez-Gerlinger MP, Mainardi, JL. Switch to oral antibiotics in the treatment of infective endocarditis is not associated with increased risk of mortality in non-severely ill patients [published online ahead of print April 16, 2016]. Clin Microbiol Infect. doi:10.1016/j.cmi.2016.04.003.

Background: Treating infective endocarditis with four to six weeks of intravenous antibiotics carries a high cost. There are data to support oral antibiotics for right-sided endocarditis due to methicillin-sensitive Staphylococcus aureus (with ciprofloxacin and rifampicin), but experience in using oral antibiotics for infective endocarditis is limited.

Study design: Cohort study.

Setting: Large academic hospital in France.

Synopsis: The researchers included 426 patients with definitive or probable endocarditis by Duke criteria. After an initial period of treatment with intravenous (IV) antibiotics, 50% of the identified group was transitioned to oral antibiotics (amoxicillin alone in 50% and combinations of fluoroquinolones, rifampicin, amoxicillin, and clindamycin in the others).

The risk of death was not increased in the group treated with oral antibiotics when adjusted for the four biggest predictors of death (age >65, type 1 diabetes mellitus, disinsertion of prosthetic valve, and endocarditis due to S. aureus). Nine patients treated with IV antibiotics experienced relapsed endocarditis compared to two patients treated with oral antibiotics.

Patients selected for treatment with oral antibiotics were less likely to have severe disease, significant comorbidities, or infection with S. aureus. The length of treatment with IV antibiotics before switching to oral antibiotics varied widely.

Bottom line: It’s possible low-risk patients with infective endocarditis may be treated with oral antibiotics, but more data are needed.

Citation: Mzabi A, Kernéis S, Richaud C, Podglajen I, Fernandez-Gerlinger MP, Mainardi, JL. Switch to oral antibiotics in the treatment of infective endocarditis is not associated with increased risk of mortality in non-severely ill patients [published online ahead of print April 16, 2016]. Clin Microbiol Infect. doi:10.1016/j.cmi.2016.04.003.

Background: Treating infective endocarditis with four to six weeks of intravenous antibiotics carries a high cost. There are data to support oral antibiotics for right-sided endocarditis due to methicillin-sensitive Staphylococcus aureus (with ciprofloxacin and rifampicin), but experience in using oral antibiotics for infective endocarditis is limited.

Study design: Cohort study.

Setting: Large academic hospital in France.

Synopsis: The researchers included 426 patients with definitive or probable endocarditis by Duke criteria. After an initial period of treatment with intravenous (IV) antibiotics, 50% of the identified group was transitioned to oral antibiotics (amoxicillin alone in 50% and combinations of fluoroquinolones, rifampicin, amoxicillin, and clindamycin in the others).

The risk of death was not increased in the group treated with oral antibiotics when adjusted for the four biggest predictors of death (age >65, type 1 diabetes mellitus, disinsertion of prosthetic valve, and endocarditis due to S. aureus). Nine patients treated with IV antibiotics experienced relapsed endocarditis compared to two patients treated with oral antibiotics.

Patients selected for treatment with oral antibiotics were less likely to have severe disease, significant comorbidities, or infection with S. aureus. The length of treatment with IV antibiotics before switching to oral antibiotics varied widely.

Bottom line: It’s possible low-risk patients with infective endocarditis may be treated with oral antibiotics, but more data are needed.

Citation: Mzabi A, Kernéis S, Richaud C, Podglajen I, Fernandez-Gerlinger MP, Mainardi, JL. Switch to oral antibiotics in the treatment of infective endocarditis is not associated with increased risk of mortality in non-severely ill patients [published online ahead of print April 16, 2016]. Clin Microbiol Infect. doi:10.1016/j.cmi.2016.04.003.

Fluorescence microscope

Researchers say they have developed a fluorescence microscopy technique that improves image resolution by acquiring 3 views of a sample at the same time.

The team applied their technique in 2 microscopy modes and used it to image several types of biological samples.

For both modes, the technique demonstrated a volumetric resolution of up to 235 by 235 by 340 nanometers, double the volumetric resolution of traditional methods.

The researchers believe this technique will prove particularly useful for watching the dynamics of biological processes, which can provide insights into the workings of healthy and diseased cells.

They described the technique in the journal Optica.

The researchers noted that most fluorescence microscopy methods fail to capture much of the fluorescence emitted from a sample, which represents lost information and reduces image resolution.

“In our work, we captured this previously neglected fluorescence and fused it with the traditional views used in conventional microscopy,” said study author Yicong Wu, PhD, of the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health in Bethesda, Maryland.

“This increases resolution without compromising either temporal resolution or adding additional light to the sample.”

Adding a third objective lens

The new multi-view approach helps improve a technique the researchers previously developed called dual-view plane illumination microscopy (diSPIM). Scientists around the world employ commercial versions of diSPIM, which uses a thin sheet of light and 2 objective lenses to excite and detect fluorescence.

“The main motivation of this new research was that the resolution in diSPIM was limited by the numerical aperture of the upper lenses, and fluorescence emitted in the direction of the coverslip is not captured,” explained study author Hari Shroff, PhD, also of the National Institute of Biomedical Imaging and Bioengineering.

“We reasoned that if we could simultaneously image this neglected signal by adding a higher numerical aperture lens that acquired the bottom view, then we could boost the lateral resolution.”

In the improved diSPIM microscopy technique, each light sheet is tilted at a 45-degree angle relative to an additional lower objective lens.

In its current design, the researchers swept the lower objective’s plane of focus through the sample to image the previously unused fluorescence, but this mechanical scanning could be replaced with a passive optic in future versions of the microscope.

Using the multi-view approach improved the lateral, or horizontal, resolution of diSPIM to about 235 nm.

The researchers also implemented the new technique in wide-field mode by scanning the 3 objectives through a sample simultaneously to produce 3 individual 3D views. With this mode, the multi-view method improved axial, or Z-axis, resolution, to about 340 nm, an increase of 45%.

Merging 3 views into 1

Whether acquired in wide-field or light-sheet mode, the 3 views must be precisely aligned and also cleaned up with an image processing technique known as deconvolution.

“One helpful trick was to deconvolve each view first to increase image quality, contrast, and so forth, which then allowed accurate registration of the 3 views,” Dr Wu said. “In wide-field mode, we further aided registration of the images by adding fluorescent beads to the samples as point of reference.”

The researchers demonstrated the multi-view technique by imaging biological samples and were able to see detailed features not typically observable.

For example, the wide-field multi-view microscope clearly resolved the spherical protein shell present when Bacillus subtilis forms a spore and also allowed the researchers to observe the dynamics of organelles inside cells.

In light-sheet mode, the team clearly saw the 3D dynamic nature of tiny protrusions on living white blood cells when they acquired 150 triple-view images over 40 minutes.

Although other methods have been used to capture multiple views sequentially, the researchers said this new method improves spatial resolution without introducing additional illumination or compromising temporal resolution relative to conventional imaging.

This is important because additional light can be damaging and even deadly to living cells, and the temporal resolution is needed to capture fast processes.

The researchers are now exploring additional biological applications for the new system and are working to extend the method to other microscope modalities, such as confocal microscopy.

Fluorescence microscope

Researchers say they have developed a fluorescence microscopy technique that improves image resolution by acquiring 3 views of a sample at the same time.

The team applied their technique in 2 microscopy modes and used it to image several types of biological samples.

For both modes, the technique demonstrated a volumetric resolution of up to 235 by 235 by 340 nanometers, double the volumetric resolution of traditional methods.

The researchers believe this technique will prove particularly useful for watching the dynamics of biological processes, which can provide insights into the workings of healthy and diseased cells.

They described the technique in the journal Optica.

The researchers noted that most fluorescence microscopy methods fail to capture much of the fluorescence emitted from a sample, which represents lost information and reduces image resolution.

“In our work, we captured this previously neglected fluorescence and fused it with the traditional views used in conventional microscopy,” said study author Yicong Wu, PhD, of the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health in Bethesda, Maryland.

“This increases resolution without compromising either temporal resolution or adding additional light to the sample.”

Adding a third objective lens

The new multi-view approach helps improve a technique the researchers previously developed called dual-view plane illumination microscopy (diSPIM). Scientists around the world employ commercial versions of diSPIM, which uses a thin sheet of light and 2 objective lenses to excite and detect fluorescence.

“The main motivation of this new research was that the resolution in diSPIM was limited by the numerical aperture of the upper lenses, and fluorescence emitted in the direction of the coverslip is not captured,” explained study author Hari Shroff, PhD, also of the National Institute of Biomedical Imaging and Bioengineering.

“We reasoned that if we could simultaneously image this neglected signal by adding a higher numerical aperture lens that acquired the bottom view, then we could boost the lateral resolution.”

In the improved diSPIM microscopy technique, each light sheet is tilted at a 45-degree angle relative to an additional lower objective lens.

In its current design, the researchers swept the lower objective’s plane of focus through the sample to image the previously unused fluorescence, but this mechanical scanning could be replaced with a passive optic in future versions of the microscope.

Using the multi-view approach improved the lateral, or horizontal, resolution of diSPIM to about 235 nm.

The researchers also implemented the new technique in wide-field mode by scanning the 3 objectives through a sample simultaneously to produce 3 individual 3D views. With this mode, the multi-view method improved axial, or Z-axis, resolution, to about 340 nm, an increase of 45%.

Merging 3 views into 1

Whether acquired in wide-field or light-sheet mode, the 3 views must be precisely aligned and also cleaned up with an image processing technique known as deconvolution.

“One helpful trick was to deconvolve each view first to increase image quality, contrast, and so forth, which then allowed accurate registration of the 3 views,” Dr Wu said. “In wide-field mode, we further aided registration of the images by adding fluorescent beads to the samples as point of reference.”

The researchers demonstrated the multi-view technique by imaging biological samples and were able to see detailed features not typically observable.

For example, the wide-field multi-view microscope clearly resolved the spherical protein shell present when Bacillus subtilis forms a spore and also allowed the researchers to observe the dynamics of organelles inside cells.

In light-sheet mode, the team clearly saw the 3D dynamic nature of tiny protrusions on living white blood cells when they acquired 150 triple-view images over 40 minutes.

Although other methods have been used to capture multiple views sequentially, the researchers said this new method improves spatial resolution without introducing additional illumination or compromising temporal resolution relative to conventional imaging.

This is important because additional light can be damaging and even deadly to living cells, and the temporal resolution is needed to capture fast processes.

The researchers are now exploring additional biological applications for the new system and are working to extend the method to other microscope modalities, such as confocal microscopy.

Fluorescence microscope

Researchers say they have developed a fluorescence microscopy technique that improves image resolution by acquiring 3 views of a sample at the same time.

The team applied their technique in 2 microscopy modes and used it to image several types of biological samples.

For both modes, the technique demonstrated a volumetric resolution of up to 235 by 235 by 340 nanometers, double the volumetric resolution of traditional methods.

The researchers believe this technique will prove particularly useful for watching the dynamics of biological processes, which can provide insights into the workings of healthy and diseased cells.

They described the technique in the journal Optica.

The researchers noted that most fluorescence microscopy methods fail to capture much of the fluorescence emitted from a sample, which represents lost information and reduces image resolution.

“In our work, we captured this previously neglected fluorescence and fused it with the traditional views used in conventional microscopy,” said study author Yicong Wu, PhD, of the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health in Bethesda, Maryland.

“This increases resolution without compromising either temporal resolution or adding additional light to the sample.”

Adding a third objective lens

The new multi-view approach helps improve a technique the researchers previously developed called dual-view plane illumination microscopy (diSPIM). Scientists around the world employ commercial versions of diSPIM, which uses a thin sheet of light and 2 objective lenses to excite and detect fluorescence.

“The main motivation of this new research was that the resolution in diSPIM was limited by the numerical aperture of the upper lenses, and fluorescence emitted in the direction of the coverslip is not captured,” explained study author Hari Shroff, PhD, also of the National Institute of Biomedical Imaging and Bioengineering.

“We reasoned that if we could simultaneously image this neglected signal by adding a higher numerical aperture lens that acquired the bottom view, then we could boost the lateral resolution.”

In the improved diSPIM microscopy technique, each light sheet is tilted at a 45-degree angle relative to an additional lower objective lens.

In its current design, the researchers swept the lower objective’s plane of focus through the sample to image the previously unused fluorescence, but this mechanical scanning could be replaced with a passive optic in future versions of the microscope.

Using the multi-view approach improved the lateral, or horizontal, resolution of diSPIM to about 235 nm.

The researchers also implemented the new technique in wide-field mode by scanning the 3 objectives through a sample simultaneously to produce 3 individual 3D views. With this mode, the multi-view method improved axial, or Z-axis, resolution, to about 340 nm, an increase of 45%.

Merging 3 views into 1

Whether acquired in wide-field or light-sheet mode, the 3 views must be precisely aligned and also cleaned up with an image processing technique known as deconvolution.

“One helpful trick was to deconvolve each view first to increase image quality, contrast, and so forth, which then allowed accurate registration of the 3 views,” Dr Wu said. “In wide-field mode, we further aided registration of the images by adding fluorescent beads to the samples as point of reference.”

The researchers demonstrated the multi-view technique by imaging biological samples and were able to see detailed features not typically observable.

For example, the wide-field multi-view microscope clearly resolved the spherical protein shell present when Bacillus subtilis forms a spore and also allowed the researchers to observe the dynamics of organelles inside cells.

In light-sheet mode, the team clearly saw the 3D dynamic nature of tiny protrusions on living white blood cells when they acquired 150 triple-view images over 40 minutes.

Although other methods have been used to capture multiple views sequentially, the researchers said this new method improves spatial resolution without introducing additional illumination or compromising temporal resolution relative to conventional imaging.

This is important because additional light can be damaging and even deadly to living cells, and the temporal resolution is needed to capture fast processes.

The researchers are now exploring additional biological applications for the new system and are working to extend the method to other microscope modalities, such as confocal microscopy.

Urine samples from a noninvasive clean-catch method have no significantly greater contamination rate than do those from urethral catheterization, making clean catch a quick, effective option to attempt before catheterization, a recent study found.

The clean-catch method uses a standard bladder stimulation technique and was most successful in infants less than 90 days old.

“Because the use of urethral catheterization is an invasive method that could be associated with adverse events in up to 20% of children, our findings support the use of the clean-catch urine standardized stimulation technique as an alternative to invasive methods to obtain a urine specimen,” wrote Mélanie Labrosse, MD, PhD, and her associates at the University of Montreal (Pediatrics. 2016 Aug 19. doi: 10.1542/peds.2016-0573). “However, until further studies on proportion and predictive factors of contamination become available, it would be more cautious to perform invasive methods in children who appear ill, who have a positive urinalysis, or before beginning antibiotics.”

©Petro Feketa/iStockphoto.com

The clean-catch method involved providing the infants an opportunity to feed over 20 minutes, after which a practitioner cleaned the genitals and the parent then held the infant by the armpits. Female infants’ hips were flexed and male infants’ legs dangled.

“Examiners then alternated between bladder stimulation maneuvers, which consisted of gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds, and lumbar paravertebral massage maneuvers for 30 seconds,” the authors wrote. “These two stimulation maneuvers were repeated until micturition began or for a maximum of 300 seconds.”

The researchers attempted the clean-catch technique with 126 infants under 6 months old. About half were boys, a quarter of whom were circumcised, and the whole sample had a median age of 55 days. The procedure took a median 45 seconds and was effective in 49% of the children (at least 1 mL of urine collected within 5 minutes).

The procedure was more likely to be effective in infants under 3 months old, with three times greater odds of success for those aged 30-59 days and four times greater odds of success for those aged 0-29 days and those aged 60-89 days (odds ratio 3.2, 4.3, and 4.4, respectively). Only 26% of the children aged 91-180 days yielded a successful clean-catch sample, compared with 61% of infants under 30 days and 54% of infants under 90 days old. UTI was present in 11 (9%) children.

Likelihood of a successful clean-catch sample was not affected by infant sex, low oral intake, or recent urination (within an hour).

While 16% of the clean catches were contaminated, this rate was not statistically different from the 6% of contaminated samples among those undergoing the invasive method.

The authors suggested using the clean-catch technique as a first attempt in two situations: ruling out UTI in children aged 2-6 months and in children under 6 months who need a urinalysis in which urine typically would be obtained noninvasively.

“In addition, trying the CCU procedure instead of using a collection bag seems reasonable, considering the wait time associated with this technique and the logistics involved in changing the bag every 30 minutes,” the authors noted.

They reported having no disclosures. No external funding source was noted in the study.

Urine samples from a noninvasive clean-catch method have no significantly greater contamination rate than do those from urethral catheterization, making clean catch a quick, effective option to attempt before catheterization, a recent study found.

The clean-catch method uses a standard bladder stimulation technique and was most successful in infants less than 90 days old.

“Because the use of urethral catheterization is an invasive method that could be associated with adverse events in up to 20% of children, our findings support the use of the clean-catch urine standardized stimulation technique as an alternative to invasive methods to obtain a urine specimen,” wrote Mélanie Labrosse, MD, PhD, and her associates at the University of Montreal (Pediatrics. 2016 Aug 19. doi: 10.1542/peds.2016-0573). “However, until further studies on proportion and predictive factors of contamination become available, it would be more cautious to perform invasive methods in children who appear ill, who have a positive urinalysis, or before beginning antibiotics.”

©Petro Feketa/iStockphoto.com

The clean-catch method involved providing the infants an opportunity to feed over 20 minutes, after which a practitioner cleaned the genitals and the parent then held the infant by the armpits. Female infants’ hips were flexed and male infants’ legs dangled.

“Examiners then alternated between bladder stimulation maneuvers, which consisted of gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds, and lumbar paravertebral massage maneuvers for 30 seconds,” the authors wrote. “These two stimulation maneuvers were repeated until micturition began or for a maximum of 300 seconds.”

The researchers attempted the clean-catch technique with 126 infants under 6 months old. About half were boys, a quarter of whom were circumcised, and the whole sample had a median age of 55 days. The procedure took a median 45 seconds and was effective in 49% of the children (at least 1 mL of urine collected within 5 minutes).

The procedure was more likely to be effective in infants under 3 months old, with three times greater odds of success for those aged 30-59 days and four times greater odds of success for those aged 0-29 days and those aged 60-89 days (odds ratio 3.2, 4.3, and 4.4, respectively). Only 26% of the children aged 91-180 days yielded a successful clean-catch sample, compared with 61% of infants under 30 days and 54% of infants under 90 days old. UTI was present in 11 (9%) children.

Likelihood of a successful clean-catch sample was not affected by infant sex, low oral intake, or recent urination (within an hour).

While 16% of the clean catches were contaminated, this rate was not statistically different from the 6% of contaminated samples among those undergoing the invasive method.

The authors suggested using the clean-catch technique as a first attempt in two situations: ruling out UTI in children aged 2-6 months and in children under 6 months who need a urinalysis in which urine typically would be obtained noninvasively.

“In addition, trying the CCU procedure instead of using a collection bag seems reasonable, considering the wait time associated with this technique and the logistics involved in changing the bag every 30 minutes,” the authors noted.

They reported having no disclosures. No external funding source was noted in the study.

Urine samples from a noninvasive clean-catch method have no significantly greater contamination rate than do those from urethral catheterization, making clean catch a quick, effective option to attempt before catheterization, a recent study found.

The clean-catch method uses a standard bladder stimulation technique and was most successful in infants less than 90 days old.

“Because the use of urethral catheterization is an invasive method that could be associated with adverse events in up to 20% of children, our findings support the use of the clean-catch urine standardized stimulation technique as an alternative to invasive methods to obtain a urine specimen,” wrote Mélanie Labrosse, MD, PhD, and her associates at the University of Montreal (Pediatrics. 2016 Aug 19. doi: 10.1542/peds.2016-0573). “However, until further studies on proportion and predictive factors of contamination become available, it would be more cautious to perform invasive methods in children who appear ill, who have a positive urinalysis, or before beginning antibiotics.”

©Petro Feketa/iStockphoto.com

The clean-catch method involved providing the infants an opportunity to feed over 20 minutes, after which a practitioner cleaned the genitals and the parent then held the infant by the armpits. Female infants’ hips were flexed and male infants’ legs dangled.

“Examiners then alternated between bladder stimulation maneuvers, which consisted of gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds, and lumbar paravertebral massage maneuvers for 30 seconds,” the authors wrote. “These two stimulation maneuvers were repeated until micturition began or for a maximum of 300 seconds.”

The researchers attempted the clean-catch technique with 126 infants under 6 months old. About half were boys, a quarter of whom were circumcised, and the whole sample had a median age of 55 days. The procedure took a median 45 seconds and was effective in 49% of the children (at least 1 mL of urine collected within 5 minutes).

The procedure was more likely to be effective in infants under 3 months old, with three times greater odds of success for those aged 30-59 days and four times greater odds of success for those aged 0-29 days and those aged 60-89 days (odds ratio 3.2, 4.3, and 4.4, respectively). Only 26% of the children aged 91-180 days yielded a successful clean-catch sample, compared with 61% of infants under 30 days and 54% of infants under 90 days old. UTI was present in 11 (9%) children.

Likelihood of a successful clean-catch sample was not affected by infant sex, low oral intake, or recent urination (within an hour).

While 16% of the clean catches were contaminated, this rate was not statistically different from the 6% of contaminated samples among those undergoing the invasive method.

The authors suggested using the clean-catch technique as a first attempt in two situations: ruling out UTI in children aged 2-6 months and in children under 6 months who need a urinalysis in which urine typically would be obtained noninvasively.

“In addition, trying the CCU procedure instead of using a collection bag seems reasonable, considering the wait time associated with this technique and the logistics involved in changing the bag every 30 minutes,” the authors noted.

They reported having no disclosures. No external funding source was noted in the study.