CHICAGO – Treatment with transcutaneous electrical nerve stimulation led to a significant cut in pain during movement in women with fibromyalgia in a randomized, controlled trial with 301 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

The findings showed that, among patients assigned to self-administered transcutaneous electrical nerve stimulation (TENS) for at least 2 hours daily for 4 weeks, 44% had at least a 30% reduction in their pain with movement while on treatment, compared with 22% of patients reporting this level of improvement in the group that received mock TENS, Leslie J. Crofford, MD, reported at the annual meeting of the American College of Rheumatology. In addition, 29% of women who received active TENS reported at least a 20% drop in fatigue plus at least a 30% cut in pain, compared with their baseline levels, whereas this level of response occurred in just 13% of women who self-administered mock TENS.

The findings showed that “TENS can safely be used in addition to other treatment to improve pain and fatigue in women with fibromyalgia,” said Dr. Crofford, professor of medicine and director of rheumatology and immunology at Vanderbilt University, Nashville, Tenn. A total of 70% of women in the actively treated group reported they felt better on a global rating of change after 4 weeks of self-treatment, compared with 30% of women in the mock-control arm.


TENS, which uses a U.S.-approved device to deliver a defined series of electrical pulses to, in this case, the cervical and lumbar spine regions during activity, also showed no signs of inducing tolerance in the study and in fact produced results suggesting cumulative benefit with chronic use while causing “minimal” adverse effects, Dr. Crofford said.

“We did this study because we thought that previous studies of TENS had been inadequate,” she explained.

“Until now, most studies of TENS have been null. This was a uniquely positive trial,” commented David T. Felson, MD, professor of medicine at Boston University.

“The size, rigor, patient selection, and the TENS parameters may have been important” for the positive results, Dr. Crofford suggested. The 300-patient study was roughly 10 times larger than prior studies of TENS, and the current study used a “very vigorous placebo,” a TENS device that delivered a mock electrical stimulus. The electrical pulses used during TENS can vary by amplitude, duration, frequency, and pattern, and the settings for each of these parameters used in the trial came from prior clinical and animal studies of TENS.

“Once our study is reviewed and published, we will post our effective TENS parameters on our website. Most TENS units are adjustable” for these parameters, Dr. Crofford said. “Some of the parameters are probably important for avoiding tolerance, so it’s important to use the parameters that we’ve shown are effective.”

TENS “is available, safe, and very well tolerated. It has the potential to change practice immediately. If you look at the effect size and number of responders, TENS treatment is comparable to drug treatment,” Dr. Crofford said in an interview. A quarter of the patients in the study were on opioids at baseline, and the effect in this subgroup was similar to the overall findings. The women in the study were an average age of 46 years and had been diagnosed with fibromyalgia for an average of 7 years. Their average body mass index was 34 kg/m².

The FAST (Fibromyalgia Activity Study with TENS) trial enrolled women aged 18-70 years who met the 1990 criteria for fibromyalgia (Arthritis Rheum. 1990 Feb;33[2]:160-72) who had not received TENS during at least the prior 5 years and scored at least 4 on pain rating during the prior week. The study randomized 103 women to receive active TENS, 99 to receive mock TENS, and 99 to receive no TENS. Patients in the TENS arms received instructions to use it for at least 2 hours a day when they were active. The study’s primary endpoint was the between-group difference in pain during a 6-min walk during TENS treatment. When measured after 4 weeks of at-home treatment, patients on active TENS had an average pain level of about 4.5 on a scale of 0-10, compared with an average score of about 5.5 among the mock-TENS group, a statistically significant difference. Both groups had essentially identical pain scores of about 6.5 at baseline.

FAST did not receive commercial funding. Dr. Crofford and Dr. Felson had no disclosures.

[email protected]

SOURCE: Crofford LJ et al. ACR Annual Meeting, Abstract LB19.

CHICAGO – Treatment with transcutaneous electrical nerve stimulation led to a significant cut in pain during movement in women with fibromyalgia in a randomized, controlled trial with 301 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

The findings showed that, among patients assigned to self-administered transcutaneous electrical nerve stimulation (TENS) for at least 2 hours daily for 4 weeks, 44% had at least a 30% reduction in their pain with movement while on treatment, compared with 22% of patients reporting this level of improvement in the group that received mock TENS, Leslie J. Crofford, MD, reported at the annual meeting of the American College of Rheumatology. In addition, 29% of women who received active TENS reported at least a 20% drop in fatigue plus at least a 30% cut in pain, compared with their baseline levels, whereas this level of response occurred in just 13% of women who self-administered mock TENS.

The findings showed that “TENS can safely be used in addition to other treatment to improve pain and fatigue in women with fibromyalgia,” said Dr. Crofford, professor of medicine and director of rheumatology and immunology at Vanderbilt University, Nashville, Tenn. A total of 70% of women in the actively treated group reported they felt better on a global rating of change after 4 weeks of self-treatment, compared with 30% of women in the mock-control arm.


TENS, which uses a U.S.-approved device to deliver a defined series of electrical pulses to, in this case, the cervical and lumbar spine regions during activity, also showed no signs of inducing tolerance in the study and in fact produced results suggesting cumulative benefit with chronic use while causing “minimal” adverse effects, Dr. Crofford said.

“We did this study because we thought that previous studies of TENS had been inadequate,” she explained.

“Until now, most studies of TENS have been null. This was a uniquely positive trial,” commented David T. Felson, MD, professor of medicine at Boston University.

“The size, rigor, patient selection, and the TENS parameters may have been important” for the positive results, Dr. Crofford suggested. The 300-patient study was roughly 10 times larger than prior studies of TENS, and the current study used a “very vigorous placebo,” a TENS device that delivered a mock electrical stimulus. The electrical pulses used during TENS can vary by amplitude, duration, frequency, and pattern, and the settings for each of these parameters used in the trial came from prior clinical and animal studies of TENS.

“Once our study is reviewed and published, we will post our effective TENS parameters on our website. Most TENS units are adjustable” for these parameters, Dr. Crofford said. “Some of the parameters are probably important for avoiding tolerance, so it’s important to use the parameters that we’ve shown are effective.”

TENS “is available, safe, and very well tolerated. It has the potential to change practice immediately. If you look at the effect size and number of responders, TENS treatment is comparable to drug treatment,” Dr. Crofford said in an interview. A quarter of the patients in the study were on opioids at baseline, and the effect in this subgroup was similar to the overall findings. The women in the study were an average age of 46 years and had been diagnosed with fibromyalgia for an average of 7 years. Their average body mass index was 34 kg/m².

The FAST (Fibromyalgia Activity Study with TENS) trial enrolled women aged 18-70 years who met the 1990 criteria for fibromyalgia (Arthritis Rheum. 1990 Feb;33[2]:160-72) who had not received TENS during at least the prior 5 years and scored at least 4 on pain rating during the prior week. The study randomized 103 women to receive active TENS, 99 to receive mock TENS, and 99 to receive no TENS. Patients in the TENS arms received instructions to use it for at least 2 hours a day when they were active. The study’s primary endpoint was the between-group difference in pain during a 6-min walk during TENS treatment. When measured after 4 weeks of at-home treatment, patients on active TENS had an average pain level of about 4.5 on a scale of 0-10, compared with an average score of about 5.5 among the mock-TENS group, a statistically significant difference. Both groups had essentially identical pain scores of about 6.5 at baseline.

FAST did not receive commercial funding. Dr. Crofford and Dr. Felson had no disclosures.

[email protected]

SOURCE: Crofford LJ et al. ACR Annual Meeting, Abstract LB19.

CHICAGO – Treatment with transcutaneous electrical nerve stimulation led to a significant cut in pain during movement in women with fibromyalgia in a randomized, controlled trial with 301 patients at two U.S. centers.

Mitchel L. Zoler/MDedge News

The findings showed that, among patients assigned to self-administered transcutaneous electrical nerve stimulation (TENS) for at least 2 hours daily for 4 weeks, 44% had at least a 30% reduction in their pain with movement while on treatment, compared with 22% of patients reporting this level of improvement in the group that received mock TENS, Leslie J. Crofford, MD, reported at the annual meeting of the American College of Rheumatology. In addition, 29% of women who received active TENS reported at least a 20% drop in fatigue plus at least a 30% cut in pain, compared with their baseline levels, whereas this level of response occurred in just 13% of women who self-administered mock TENS.

The findings showed that “TENS can safely be used in addition to other treatment to improve pain and fatigue in women with fibromyalgia,” said Dr. Crofford, professor of medicine and director of rheumatology and immunology at Vanderbilt University, Nashville, Tenn. A total of 70% of women in the actively treated group reported they felt better on a global rating of change after 4 weeks of self-treatment, compared with 30% of women in the mock-control arm.


TENS, which uses a U.S.-approved device to deliver a defined series of electrical pulses to, in this case, the cervical and lumbar spine regions during activity, also showed no signs of inducing tolerance in the study and in fact produced results suggesting cumulative benefit with chronic use while causing “minimal” adverse effects, Dr. Crofford said.

“We did this study because we thought that previous studies of TENS had been inadequate,” she explained.

“Until now, most studies of TENS have been null. This was a uniquely positive trial,” commented David T. Felson, MD, professor of medicine at Boston University.

“The size, rigor, patient selection, and the TENS parameters may have been important” for the positive results, Dr. Crofford suggested. The 300-patient study was roughly 10 times larger than prior studies of TENS, and the current study used a “very vigorous placebo,” a TENS device that delivered a mock electrical stimulus. The electrical pulses used during TENS can vary by amplitude, duration, frequency, and pattern, and the settings for each of these parameters used in the trial came from prior clinical and animal studies of TENS.

“Once our study is reviewed and published, we will post our effective TENS parameters on our website. Most TENS units are adjustable” for these parameters, Dr. Crofford said. “Some of the parameters are probably important for avoiding tolerance, so it’s important to use the parameters that we’ve shown are effective.”

TENS “is available, safe, and very well tolerated. It has the potential to change practice immediately. If you look at the effect size and number of responders, TENS treatment is comparable to drug treatment,” Dr. Crofford said in an interview. A quarter of the patients in the study were on opioids at baseline, and the effect in this subgroup was similar to the overall findings. The women in the study were an average age of 46 years and had been diagnosed with fibromyalgia for an average of 7 years. Their average body mass index was 34 kg/m².

The FAST (Fibromyalgia Activity Study with TENS) trial enrolled women aged 18-70 years who met the 1990 criteria for fibromyalgia (Arthritis Rheum. 1990 Feb;33[2]:160-72) who had not received TENS during at least the prior 5 years and scored at least 4 on pain rating during the prior week. The study randomized 103 women to receive active TENS, 99 to receive mock TENS, and 99 to receive no TENS. Patients in the TENS arms received instructions to use it for at least 2 hours a day when they were active. The study’s primary endpoint was the between-group difference in pain during a 6-min walk during TENS treatment. When measured after 4 weeks of at-home treatment, patients on active TENS had an average pain level of about 4.5 on a scale of 0-10, compared with an average score of about 5.5 among the mock-TENS group, a statistically significant difference. Both groups had essentially identical pain scores of about 6.5 at baseline.

FAST did not receive commercial funding. Dr. Crofford and Dr. Felson had no disclosures.

[email protected]

SOURCE: Crofford LJ et al. ACR Annual Meeting, Abstract LB19.

BERLIN – Escalating treatment to a “highly effective” disease-modifying treatment (DMT) results in fewer relapses in patients with relapsing-remitting multiple sclerosis (RRMS) than does switching to another “moderately effective” therapy, according to data from a Danish cohort study.

Sara Freeman/MDedge News

The annualized relapse rate (ARR) was 0.23 for patients who switched to a highly effective DMT, defined as either natalizumab (Tysabri) or fingolimod (Gilenya), whereas the ARR was 0.35 in those who were switched to a moderately effective DMT, defined as an interferon-beta, glatiramer acetate (Copaxone), teriflunomide (Aubagio), or dimethyl fumarate (Tecfidera).

This resulted in a relapse-rate ratio of 0.67 (95% confidence interval [CI], 0.55-0.83) comparing high to moderate DMT, or a 33% lower relapse rate in the high DMT group, Thor Ameri Chalmer, MD, PhD, reported at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Dr. Chalmer, who works at the Danish Multiple Sclerosis Center at Rigshospitalet, the University of Copenhagen, reported that the time to first relapse and the likelihood for having recurrent relapses were all lowered by escalating treatment rather than switching treatment. Indeed, there was a 38% increase in the time to first relapse (hazard ratio [HR] = 0.62; 95% CI, 0.50-0.76) and a 31% reduction in recurrent relapses (HR = 0.69; 95% CI, 0.57-0.83).

However, there were “no clear differences” in the time to 3-month confirmed Expanded Disability Status Scale (EDSS) worsening and improvement, Dr. Chalmer said. The HR for time to first worsening in the 3-month confirmed EDSS was 0.86, and for recurrent worsening it was 0.86, but the 95% CI in both cases crossed over from 1.0 (0.65-1.14 and 0.71-1.05, respectively). There was no difference in the time to first improvement (HR = 1.23; 95% CI, 0.95-1.60).

“The aim of this study was to use data from the [Danish] MS Registry, find the patients who started on what we define as moderately effective DMT for the first time, and on this treatment experienced a disease breakthrough and then either switched to another moderately effective DMT or escalated to a highly effective DMT,” Dr. Chalmer explained.

Disease breakthrough was defined as at least one relapse occurring within 12 months of the treatment switch, or the treating neurologist defined the reason for switching as disease breakthrough. Dr. Chalmer acknowledged that this was one of the limitations of the observational study as patients could have been misclassified and switched treatment for another reason. The severity of the relapse was not recorded.

Data on more than 5,000 patients enrolled in the Danish Multiple Sclerosis Registry (DMSR) were considered, with a final propensity-match population of 788 included in the analysis; half had received highly effective DMT and half moderately effective DMT.

The DMSR contains data on virtually all patients with MS treated in Denmark, Dr. Chalmer observed; treatment with DMT is free of charge and it can be prescribed only in public MS clinics, he explained. Furthermore, all MS clinics are required to register information about treatment response at each clinical visit.

The mean age of patients in the study was 39 years, around 70% were female, and average disease duration was 5 years.

“I don’t see in your study what is really new,” Gilles Edan, MD, observed during a discussion. “We know that using more active, more efficient drugs gives more control on relapse.”

Dr. Edan, professor and head of the neurosciences department of University Hospital Pontchaillou, Rennes (France), added that these data “confirmed what has already been observed in the clinical trials.”

It is important to consider the safety and efficacy concerns on an individual level, Dr. Edan argued, questioning whether the more highly active drugs should be systematically used first-line rather than second-line in all patients with MS. He also noted that of course patients would need to be treated for very long periods.

Dr. Chalmer responded: “I agree some of the randomized trials have touched upon on this as well, but I think it’s really important to not just rely on one or two trials but to keep on doing the trials over and over again so that we show that we have the right results.”

Dr. Chalmer added that the present study looked only at efficacy and that the median follow-up time was 3.2 years. “Safety is important of course, but it was not the aim of this study.” Perhaps longer follow-up might have detected more differences in the EDSS outcomes, he added.

The study was funded by the Danish Multiple Sclerosis Society, the Foundation for Research in Neurology, Ejnar Jonassen, and Gangstedfonden. Dr. Chalmer disclosed he had received support for congress participation from Merck, Biogen, and Roche.

SOURCE: Chalmer T et al. Mult Scler. 2018;24(S2):99. Abstract 263.

BERLIN – Escalating treatment to a “highly effective” disease-modifying treatment (DMT) results in fewer relapses in patients with relapsing-remitting multiple sclerosis (RRMS) than does switching to another “moderately effective” therapy, according to data from a Danish cohort study.

Sara Freeman/MDedge News

The annualized relapse rate (ARR) was 0.23 for patients who switched to a highly effective DMT, defined as either natalizumab (Tysabri) or fingolimod (Gilenya), whereas the ARR was 0.35 in those who were switched to a moderately effective DMT, defined as an interferon-beta, glatiramer acetate (Copaxone), teriflunomide (Aubagio), or dimethyl fumarate (Tecfidera).

This resulted in a relapse-rate ratio of 0.67 (95% confidence interval [CI], 0.55-0.83) comparing high to moderate DMT, or a 33% lower relapse rate in the high DMT group, Thor Ameri Chalmer, MD, PhD, reported at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Dr. Chalmer, who works at the Danish Multiple Sclerosis Center at Rigshospitalet, the University of Copenhagen, reported that the time to first relapse and the likelihood for having recurrent relapses were all lowered by escalating treatment rather than switching treatment. Indeed, there was a 38% increase in the time to first relapse (hazard ratio [HR] = 0.62; 95% CI, 0.50-0.76) and a 31% reduction in recurrent relapses (HR = 0.69; 95% CI, 0.57-0.83).

However, there were “no clear differences” in the time to 3-month confirmed Expanded Disability Status Scale (EDSS) worsening and improvement, Dr. Chalmer said. The HR for time to first worsening in the 3-month confirmed EDSS was 0.86, and for recurrent worsening it was 0.86, but the 95% CI in both cases crossed over from 1.0 (0.65-1.14 and 0.71-1.05, respectively). There was no difference in the time to first improvement (HR = 1.23; 95% CI, 0.95-1.60).

“The aim of this study was to use data from the [Danish] MS Registry, find the patients who started on what we define as moderately effective DMT for the first time, and on this treatment experienced a disease breakthrough and then either switched to another moderately effective DMT or escalated to a highly effective DMT,” Dr. Chalmer explained.

Disease breakthrough was defined as at least one relapse occurring within 12 months of the treatment switch, or the treating neurologist defined the reason for switching as disease breakthrough. Dr. Chalmer acknowledged that this was one of the limitations of the observational study as patients could have been misclassified and switched treatment for another reason. The severity of the relapse was not recorded.

Data on more than 5,000 patients enrolled in the Danish Multiple Sclerosis Registry (DMSR) were considered, with a final propensity-match population of 788 included in the analysis; half had received highly effective DMT and half moderately effective DMT.

The DMSR contains data on virtually all patients with MS treated in Denmark, Dr. Chalmer observed; treatment with DMT is free of charge and it can be prescribed only in public MS clinics, he explained. Furthermore, all MS clinics are required to register information about treatment response at each clinical visit.

The mean age of patients in the study was 39 years, around 70% were female, and average disease duration was 5 years.

“I don’t see in your study what is really new,” Gilles Edan, MD, observed during a discussion. “We know that using more active, more efficient drugs gives more control on relapse.”

Dr. Edan, professor and head of the neurosciences department of University Hospital Pontchaillou, Rennes (France), added that these data “confirmed what has already been observed in the clinical trials.”

It is important to consider the safety and efficacy concerns on an individual level, Dr. Edan argued, questioning whether the more highly active drugs should be systematically used first-line rather than second-line in all patients with MS. He also noted that of course patients would need to be treated for very long periods.

Dr. Chalmer responded: “I agree some of the randomized trials have touched upon on this as well, but I think it’s really important to not just rely on one or two trials but to keep on doing the trials over and over again so that we show that we have the right results.”

Dr. Chalmer added that the present study looked only at efficacy and that the median follow-up time was 3.2 years. “Safety is important of course, but it was not the aim of this study.” Perhaps longer follow-up might have detected more differences in the EDSS outcomes, he added.

The study was funded by the Danish Multiple Sclerosis Society, the Foundation for Research in Neurology, Ejnar Jonassen, and Gangstedfonden. Dr. Chalmer disclosed he had received support for congress participation from Merck, Biogen, and Roche.

SOURCE: Chalmer T et al. Mult Scler. 2018;24(S2):99. Abstract 263.

BERLIN – Escalating treatment to a “highly effective” disease-modifying treatment (DMT) results in fewer relapses in patients with relapsing-remitting multiple sclerosis (RRMS) than does switching to another “moderately effective” therapy, according to data from a Danish cohort study.

Sara Freeman/MDedge News

The annualized relapse rate (ARR) was 0.23 for patients who switched to a highly effective DMT, defined as either natalizumab (Tysabri) or fingolimod (Gilenya), whereas the ARR was 0.35 in those who were switched to a moderately effective DMT, defined as an interferon-beta, glatiramer acetate (Copaxone), teriflunomide (Aubagio), or dimethyl fumarate (Tecfidera).

This resulted in a relapse-rate ratio of 0.67 (95% confidence interval [CI], 0.55-0.83) comparing high to moderate DMT, or a 33% lower relapse rate in the high DMT group, Thor Ameri Chalmer, MD, PhD, reported at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Dr. Chalmer, who works at the Danish Multiple Sclerosis Center at Rigshospitalet, the University of Copenhagen, reported that the time to first relapse and the likelihood for having recurrent relapses were all lowered by escalating treatment rather than switching treatment. Indeed, there was a 38% increase in the time to first relapse (hazard ratio [HR] = 0.62; 95% CI, 0.50-0.76) and a 31% reduction in recurrent relapses (HR = 0.69; 95% CI, 0.57-0.83).

However, there were “no clear differences” in the time to 3-month confirmed Expanded Disability Status Scale (EDSS) worsening and improvement, Dr. Chalmer said. The HR for time to first worsening in the 3-month confirmed EDSS was 0.86, and for recurrent worsening it was 0.86, but the 95% CI in both cases crossed over from 1.0 (0.65-1.14 and 0.71-1.05, respectively). There was no difference in the time to first improvement (HR = 1.23; 95% CI, 0.95-1.60).

“The aim of this study was to use data from the [Danish] MS Registry, find the patients who started on what we define as moderately effective DMT for the first time, and on this treatment experienced a disease breakthrough and then either switched to another moderately effective DMT or escalated to a highly effective DMT,” Dr. Chalmer explained.

Disease breakthrough was defined as at least one relapse occurring within 12 months of the treatment switch, or the treating neurologist defined the reason for switching as disease breakthrough. Dr. Chalmer acknowledged that this was one of the limitations of the observational study as patients could have been misclassified and switched treatment for another reason. The severity of the relapse was not recorded.

Data on more than 5,000 patients enrolled in the Danish Multiple Sclerosis Registry (DMSR) were considered, with a final propensity-match population of 788 included in the analysis; half had received highly effective DMT and half moderately effective DMT.

The DMSR contains data on virtually all patients with MS treated in Denmark, Dr. Chalmer observed; treatment with DMT is free of charge and it can be prescribed only in public MS clinics, he explained. Furthermore, all MS clinics are required to register information about treatment response at each clinical visit.

The mean age of patients in the study was 39 years, around 70% were female, and average disease duration was 5 years.

“I don’t see in your study what is really new,” Gilles Edan, MD, observed during a discussion. “We know that using more active, more efficient drugs gives more control on relapse.”

Dr. Edan, professor and head of the neurosciences department of University Hospital Pontchaillou, Rennes (France), added that these data “confirmed what has already been observed in the clinical trials.”

It is important to consider the safety and efficacy concerns on an individual level, Dr. Edan argued, questioning whether the more highly active drugs should be systematically used first-line rather than second-line in all patients with MS. He also noted that of course patients would need to be treated for very long periods.

Dr. Chalmer responded: “I agree some of the randomized trials have touched upon on this as well, but I think it’s really important to not just rely on one or two trials but to keep on doing the trials over and over again so that we show that we have the right results.”

Dr. Chalmer added that the present study looked only at efficacy and that the median follow-up time was 3.2 years. “Safety is important of course, but it was not the aim of this study.” Perhaps longer follow-up might have detected more differences in the EDSS outcomes, he added.

The study was funded by the Danish Multiple Sclerosis Society, the Foundation for Research in Neurology, Ejnar Jonassen, and Gangstedfonden. Dr. Chalmer disclosed he had received support for congress participation from Merck, Biogen, and Roche.

SOURCE: Chalmer T et al. Mult Scler. 2018;24(S2):99. Abstract 263.

A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Piotr Marcinski/Thinkstock

To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.

He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).

The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.

Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.

“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.

The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.

Dr. Thompson had no financial conflicts to disclose.

A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Piotr Marcinski/Thinkstock

To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.

He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).

The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.

Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.

“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.

The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.

Dr. Thompson had no financial conflicts to disclose.

A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.

Piotr Marcinski/Thinkstock

To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.

He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).

The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.

Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.

“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.

The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.

Dr. Thompson had no financial conflicts to disclose.

MUNICH – The term “practice-changing trial” usually implies change for the better, but results of a study comparing two regimens for patients with low-risk human papillomavirus–positive oropharyngeal cancer showed that cetuximab plus radiation was associated with worse local control and worse overall survival than the older standard of cisplatin plus radiation, investigators in the De-Escalate HPV trial reported.

Although rates of severe toxicity, the primary endpoint, were similar between cisplatin and radiation and cetuximab (Erbitux) plus radiation, 2-year overall survival was significantly worse with cetuximab, a finding that caught the investigators off guard, admitted Hisham Mehanna, PhD, a surgeon at the Institute of Head and Neck Studies and Education at the University of Birmingham (England).

Neil Osterweil/MDedge News

“This difference in overall survival was underpinned by a significantly higher recurrence rate with cetuximab,” he said at the European Society of Medical Oncology Congress. “And that recurrence rate was both in locoregional control as well as in distant control.”

The results of the study reaffirm that cisplatin remains the standard of care in patients with low-risk human papillomavirus (HPV)–positive oropharyngeal cancer, and highlight the vital importance of carefully controlled clinical trials.

“I think there’s a salutary lesson: Changes in standard of care really should only be done of the basis of high-level, phase 3 comparative evidence, even, as was in our case, when treatments have been approved by regulatory bodies,” he said.

The trial raises the question of whether deintensification strategies should continue to be used in locally advanced HPV-positive oropharyngeal cancer, and suggests that clinicians should rethink the use of targeted agents in these patients in the absence of predictive biomarkers, commented Amanda Psyrri, MD, PhD, from the University of Athens and Attikon University Hospital.

The standard of care for patients with head and neck cancers is radiotherapy with concomitant cisplatin, which has been shown to improve absolute overall survival at the cost of increases in both acute and late severe toxicities.

The De-Escalate HPV trial was designed to see whether replacing cisplatin with cetuximab, a tyrosine kinase inhibitor targeted against the epidermal growth factor receptor, could be associated with less toxicity, better quality of life, and better swallowing in patients with low-risk HPV-positive oropharyngeal cancer.

The investigators enrolled 334 patients from 32 centers in the United Kingdom, Ireland, and the Netherlands, and randomly assigned them to therapy with 70 Gy radiotherapy given in 35 fractions over 7 weeks, plus either intravenous cisplatin 100 mg/m² per day on days 1, 22, and 43, or IV cetuximab at a 400 mg pretreatment loading dose, then 250 mg weekly.

There were no significant differences between treatment arms in the primary endpoint of toxicity, either severe (grade 3-5) or all grades of toxicity (1-5). In addition, there were no significant differences between the treatment arms in global health status assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire – Core Questionnaire (EORTC QLQ-C30) or in swallowing as evaluated by the MD Anderson Dysphagia Inventory-Global.

There were, however, significantly more serious adverse events in the cisplatin arm, at 162 versus 95 in the cetuximab arm.

But as noted before, the investigators were surprised to see that 2-year overall survival was worse with cetuximab at 89.4%, compared with 97.5% for cisplatin (P = .001). The hazard ratio for death with cetuximab was 4.99 and the adjusted HR was 5.94 (P = .001). Dr. Mehanna did not report factors considered in the adjusted HR.

The number needed to treat for harm was 12.

“Our study was not powered to identify a difference in survival, and hence our surprise to find a significantly worse overall survival with cetuximab,” he said.

The 2-year recurrence rates were 6.0% in the cisplatin arm versus 16.1% in the cetuximab arm (HR, 3.39; P = .0007).

Locoregional recurrence rates were 3% in the cisplatin arm versus 12% in the cetuximab arm and rates of distant recurrence were 3% versus 9%, respectively.

The results suggest that clinicians should be cautious when considering deescalation treatments that reduce the use of systemic chemotherapy, either with radiotherapy alone or with surgery, Dr. Mehanna said.

Neil Osterweil/MDedge News

In a briefing prior to the presentation of the data in a presidential symposium, discussant Jean-Pascal Machiels, MD, from the University Clinic Saint-Luc in Brussels, said that, prior to this study, “the common belief was that [cetuximab and radiation] could be used, maybe, instead of chemoradiation in these patients, because also we believed that this may decrease toxicity.

“But clearly we have a signal that the chemoradiation has more activity in this setting, and it should remain the standard of care,” he continued.

Dr. Machiels cautioned that the findings cannot be extrapolated to patients with HPV-negative disease.

The study was sponsored by the University of Warwick (England), University of Birmingham, University of Oxford (England), and Cancer Research UK. Dr. Mehanna reported honoraria from AstraZeneca, MSD, Sanofi Pasteur, and Merck, and is a director and stockholder of the Warwickshire Head and Neck Clinic. Dr. Psyrri reported honoraria from Merck Serono, Roche, MSD, AstraZeneca, Bristol-Myers Squibb, Bayer, Pfizer, Medscape, and Prime Oncology. Dr. Machiels reported a consulting or advisory role with Boehringer Ingelheim, Debiopharm Group, Innate Pharma, Merck, Nanobiotix, and Pfizer, and research funding from Bayer, Janssen Pharmaceuticals, Novartis, and Sanofi.

SOURCE: Mehanna H et al. ESMO 2018, Abstract LBA9_PR.

MUNICH – The term “practice-changing trial” usually implies change for the better, but results of a study comparing two regimens for patients with low-risk human papillomavirus–positive oropharyngeal cancer showed that cetuximab plus radiation was associated with worse local control and worse overall survival than the older standard of cisplatin plus radiation, investigators in the De-Escalate HPV trial reported.

Although rates of severe toxicity, the primary endpoint, were similar between cisplatin and radiation and cetuximab (Erbitux) plus radiation, 2-year overall survival was significantly worse with cetuximab, a finding that caught the investigators off guard, admitted Hisham Mehanna, PhD, a surgeon at the Institute of Head and Neck Studies and Education at the University of Birmingham (England).

Neil Osterweil/MDedge News

“This difference in overall survival was underpinned by a significantly higher recurrence rate with cetuximab,” he said at the European Society of Medical Oncology Congress. “And that recurrence rate was both in locoregional control as well as in distant control.”

The results of the study reaffirm that cisplatin remains the standard of care in patients with low-risk human papillomavirus (HPV)–positive oropharyngeal cancer, and highlight the vital importance of carefully controlled clinical trials.

“I think there’s a salutary lesson: Changes in standard of care really should only be done of the basis of high-level, phase 3 comparative evidence, even, as was in our case, when treatments have been approved by regulatory bodies,” he said.

The trial raises the question of whether deintensification strategies should continue to be used in locally advanced HPV-positive oropharyngeal cancer, and suggests that clinicians should rethink the use of targeted agents in these patients in the absence of predictive biomarkers, commented Amanda Psyrri, MD, PhD, from the University of Athens and Attikon University Hospital.

The standard of care for patients with head and neck cancers is radiotherapy with concomitant cisplatin, which has been shown to improve absolute overall survival at the cost of increases in both acute and late severe toxicities.

The De-Escalate HPV trial was designed to see whether replacing cisplatin with cetuximab, a tyrosine kinase inhibitor targeted against the epidermal growth factor receptor, could be associated with less toxicity, better quality of life, and better swallowing in patients with low-risk HPV-positive oropharyngeal cancer.

The investigators enrolled 334 patients from 32 centers in the United Kingdom, Ireland, and the Netherlands, and randomly assigned them to therapy with 70 Gy radiotherapy given in 35 fractions over 7 weeks, plus either intravenous cisplatin 100 mg/m² per day on days 1, 22, and 43, or IV cetuximab at a 400 mg pretreatment loading dose, then 250 mg weekly.

There were no significant differences between treatment arms in the primary endpoint of toxicity, either severe (grade 3-5) or all grades of toxicity (1-5). In addition, there were no significant differences between the treatment arms in global health status assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire – Core Questionnaire (EORTC QLQ-C30) or in swallowing as evaluated by the MD Anderson Dysphagia Inventory-Global.

There were, however, significantly more serious adverse events in the cisplatin arm, at 162 versus 95 in the cetuximab arm.

But as noted before, the investigators were surprised to see that 2-year overall survival was worse with cetuximab at 89.4%, compared with 97.5% for cisplatin (P = .001). The hazard ratio for death with cetuximab was 4.99 and the adjusted HR was 5.94 (P = .001). Dr. Mehanna did not report factors considered in the adjusted HR.

The number needed to treat for harm was 12.

“Our study was not powered to identify a difference in survival, and hence our surprise to find a significantly worse overall survival with cetuximab,” he said.

The 2-year recurrence rates were 6.0% in the cisplatin arm versus 16.1% in the cetuximab arm (HR, 3.39; P = .0007).

Locoregional recurrence rates were 3% in the cisplatin arm versus 12% in the cetuximab arm and rates of distant recurrence were 3% versus 9%, respectively.

The results suggest that clinicians should be cautious when considering deescalation treatments that reduce the use of systemic chemotherapy, either with radiotherapy alone or with surgery, Dr. Mehanna said.

Neil Osterweil/MDedge News

In a briefing prior to the presentation of the data in a presidential symposium, discussant Jean-Pascal Machiels, MD, from the University Clinic Saint-Luc in Brussels, said that, prior to this study, “the common belief was that [cetuximab and radiation] could be used, maybe, instead of chemoradiation in these patients, because also we believed that this may decrease toxicity.

“But clearly we have a signal that the chemoradiation has more activity in this setting, and it should remain the standard of care,” he continued.

Dr. Machiels cautioned that the findings cannot be extrapolated to patients with HPV-negative disease.

The study was sponsored by the University of Warwick (England), University of Birmingham, University of Oxford (England), and Cancer Research UK. Dr. Mehanna reported honoraria from AstraZeneca, MSD, Sanofi Pasteur, and Merck, and is a director and stockholder of the Warwickshire Head and Neck Clinic. Dr. Psyrri reported honoraria from Merck Serono, Roche, MSD, AstraZeneca, Bristol-Myers Squibb, Bayer, Pfizer, Medscape, and Prime Oncology. Dr. Machiels reported a consulting or advisory role with Boehringer Ingelheim, Debiopharm Group, Innate Pharma, Merck, Nanobiotix, and Pfizer, and research funding from Bayer, Janssen Pharmaceuticals, Novartis, and Sanofi.

SOURCE: Mehanna H et al. ESMO 2018, Abstract LBA9_PR.

MUNICH – The term “practice-changing trial” usually implies change for the better, but results of a study comparing two regimens for patients with low-risk human papillomavirus–positive oropharyngeal cancer showed that cetuximab plus radiation was associated with worse local control and worse overall survival than the older standard of cisplatin plus radiation, investigators in the De-Escalate HPV trial reported.

Although rates of severe toxicity, the primary endpoint, were similar between cisplatin and radiation and cetuximab (Erbitux) plus radiation, 2-year overall survival was significantly worse with cetuximab, a finding that caught the investigators off guard, admitted Hisham Mehanna, PhD, a surgeon at the Institute of Head and Neck Studies and Education at the University of Birmingham (England).

Neil Osterweil/MDedge News

“This difference in overall survival was underpinned by a significantly higher recurrence rate with cetuximab,” he said at the European Society of Medical Oncology Congress. “And that recurrence rate was both in locoregional control as well as in distant control.”

The results of the study reaffirm that cisplatin remains the standard of care in patients with low-risk human papillomavirus (HPV)–positive oropharyngeal cancer, and highlight the vital importance of carefully controlled clinical trials.

“I think there’s a salutary lesson: Changes in standard of care really should only be done of the basis of high-level, phase 3 comparative evidence, even, as was in our case, when treatments have been approved by regulatory bodies,” he said.

The trial raises the question of whether deintensification strategies should continue to be used in locally advanced HPV-positive oropharyngeal cancer, and suggests that clinicians should rethink the use of targeted agents in these patients in the absence of predictive biomarkers, commented Amanda Psyrri, MD, PhD, from the University of Athens and Attikon University Hospital.

The standard of care for patients with head and neck cancers is radiotherapy with concomitant cisplatin, which has been shown to improve absolute overall survival at the cost of increases in both acute and late severe toxicities.

The De-Escalate HPV trial was designed to see whether replacing cisplatin with cetuximab, a tyrosine kinase inhibitor targeted against the epidermal growth factor receptor, could be associated with less toxicity, better quality of life, and better swallowing in patients with low-risk HPV-positive oropharyngeal cancer.

The investigators enrolled 334 patients from 32 centers in the United Kingdom, Ireland, and the Netherlands, and randomly assigned them to therapy with 70 Gy radiotherapy given in 35 fractions over 7 weeks, plus either intravenous cisplatin 100 mg/m² per day on days 1, 22, and 43, or IV cetuximab at a 400 mg pretreatment loading dose, then 250 mg weekly.

There were no significant differences between treatment arms in the primary endpoint of toxicity, either severe (grade 3-5) or all grades of toxicity (1-5). In addition, there were no significant differences between the treatment arms in global health status assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire – Core Questionnaire (EORTC QLQ-C30) or in swallowing as evaluated by the MD Anderson Dysphagia Inventory-Global.

There were, however, significantly more serious adverse events in the cisplatin arm, at 162 versus 95 in the cetuximab arm.

But as noted before, the investigators were surprised to see that 2-year overall survival was worse with cetuximab at 89.4%, compared with 97.5% for cisplatin (P = .001). The hazard ratio for death with cetuximab was 4.99 and the adjusted HR was 5.94 (P = .001). Dr. Mehanna did not report factors considered in the adjusted HR.

The number needed to treat for harm was 12.

“Our study was not powered to identify a difference in survival, and hence our surprise to find a significantly worse overall survival with cetuximab,” he said.

The 2-year recurrence rates were 6.0% in the cisplatin arm versus 16.1% in the cetuximab arm (HR, 3.39; P = .0007).

Locoregional recurrence rates were 3% in the cisplatin arm versus 12% in the cetuximab arm and rates of distant recurrence were 3% versus 9%, respectively.

The results suggest that clinicians should be cautious when considering deescalation treatments that reduce the use of systemic chemotherapy, either with radiotherapy alone or with surgery, Dr. Mehanna said.

Neil Osterweil/MDedge News

In a briefing prior to the presentation of the data in a presidential symposium, discussant Jean-Pascal Machiels, MD, from the University Clinic Saint-Luc in Brussels, said that, prior to this study, “the common belief was that [cetuximab and radiation] could be used, maybe, instead of chemoradiation in these patients, because also we believed that this may decrease toxicity.

“But clearly we have a signal that the chemoradiation has more activity in this setting, and it should remain the standard of care,” he continued.

Dr. Machiels cautioned that the findings cannot be extrapolated to patients with HPV-negative disease.

The study was sponsored by the University of Warwick (England), University of Birmingham, University of Oxford (England), and Cancer Research UK. Dr. Mehanna reported honoraria from AstraZeneca, MSD, Sanofi Pasteur, and Merck, and is a director and stockholder of the Warwickshire Head and Neck Clinic. Dr. Psyrri reported honoraria from Merck Serono, Roche, MSD, AstraZeneca, Bristol-Myers Squibb, Bayer, Pfizer, Medscape, and Prime Oncology. Dr. Machiels reported a consulting or advisory role with Boehringer Ingelheim, Debiopharm Group, Innate Pharma, Merck, Nanobiotix, and Pfizer, and research funding from Bayer, Janssen Pharmaceuticals, Novartis, and Sanofi.

SOURCE: Mehanna H et al. ESMO 2018, Abstract LBA9_PR.

The Centers for Medicare and Medicaid services announced last week that it will test paying for Part B drugs by more closely aligning those payments with international rates. Also today, statins cut all-cause mortality in spinal cord injury, ACR readies first-ever guidelines on managing reproductive health, and primary care holds the key to curbing early-onset colorectal cancer.

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The Centers for Medicare and Medicaid services announced last week that it will test paying for Part B drugs by more closely aligning those payments with international rates. Also today, statins cut all-cause mortality in spinal cord injury, ACR readies first-ever guidelines on managing reproductive health, and primary care holds the key to curbing early-onset colorectal cancer.

Amazon Alexa
Apple Podcasts
Spotify

The Centers for Medicare and Medicaid services announced last week that it will test paying for Part B drugs by more closely aligning those payments with international rates. Also today, statins cut all-cause mortality in spinal cord injury, ACR readies first-ever guidelines on managing reproductive health, and primary care holds the key to curbing early-onset colorectal cancer.

Amazon Alexa
Apple Podcasts
Spotify

The Elizabeth Dole Center of Excellence for Veteran and Caregiver Research, the first of its kind, recognizes Senator Dole for her national leadership and advocacy on behalf of the nation’s 5.5 million military and veteran caregivers.

Managed by the Office of Health Services, the center will “serve as the model for excellence” for peer-reviewed research on innovation, training, evaluation, implementation, and dissemination of best practices in supporting caregivers of veterans.

The team of VA investigators will be led by Dr. Luci Leykum of the South Texas Veterans Health Care System. Collaborating sites and leaders include Dr. Stuti Dang of the Miami VA Health Care System, Dr. Mary Jo Pugh of the VA Salt Lake City Health Care System, and Dr. Ranak Trivedi of the VA Palo Alto Health Care System.

The Elizabeth Dole Center of Excellence for Veteran and Caregiver Research, the first of its kind, recognizes Senator Dole for her national leadership and advocacy on behalf of the nation’s 5.5 million military and veteran caregivers.

Managed by the Office of Health Services, the center will “serve as the model for excellence” for peer-reviewed research on innovation, training, evaluation, implementation, and dissemination of best practices in supporting caregivers of veterans.

The team of VA investigators will be led by Dr. Luci Leykum of the South Texas Veterans Health Care System. Collaborating sites and leaders include Dr. Stuti Dang of the Miami VA Health Care System, Dr. Mary Jo Pugh of the VA Salt Lake City Health Care System, and Dr. Ranak Trivedi of the VA Palo Alto Health Care System.

The Elizabeth Dole Center of Excellence for Veteran and Caregiver Research, the first of its kind, recognizes Senator Dole for her national leadership and advocacy on behalf of the nation’s 5.5 million military and veteran caregivers.

Managed by the Office of Health Services, the center will “serve as the model for excellence” for peer-reviewed research on innovation, training, evaluation, implementation, and dissemination of best practices in supporting caregivers of veterans.

The team of VA investigators will be led by Dr. Luci Leykum of the South Texas Veterans Health Care System. Collaborating sites and leaders include Dr. Stuti Dang of the Miami VA Health Care System, Dr. Mary Jo Pugh of the VA Salt Lake City Health Care System, and Dr. Ranak Trivedi of the VA Palo Alto Health Care System.

Photo from UAB Hospital

Public calls for blood donations in response to mass shootings may be unnecessary and result in waste, according to researchers.

Mass shootings often trigger a sharp increase in blood donations for affected communities.

In response to the recent mass shooting at the Tree Of Life Synagogue in Pittsburgh, Pennsylvania, multiple news outlets called for blood donations, and local blood centers extended their hours to compensate for the increase in donations.

However, a new study suggests that blood products donated in response to mass shootings may go unused and have to be discarded.

This study was published in The Journal of Trauma and Acute Care Surgery.

The study authors focused on blood donated in response to the mass shooting that took place in Las Vegas on October 1, 2017. This shooting resulted in 58 deaths, 869 injuries, 220 hospital admissions, and at least 68 critical care admissions.

Three healthcare systems provided data for the study. In all, 519 shooting victims were treated within these systems, and 185 were admitted to the hospitals. During the first 24 hours, these patients received 499 blood components, or 2.7 units per admission.

“From our data, it is likely that the total 1-day blood component transfusions needed in Las Vegas were more than in any mass shooting on record,” said study author M. James Lozada, DO, of Vanderbilt University Medical Center in Nashville, Tennessee.

However, the blood donations made in response to the shooting surpassed the need.

A public call for blood donations was issued during a press conference in the early hours of October 2, and that call was amplified in news stories. Stories about blood donation in Las Vegas increased from a daily average of 10 to more than 100 on October 2.

From October 2 to 4, the American Red Cross saw a 53% increase in blood donations nationwide.

The Las Vegas blood bank, United Blood Services, reported receiving 791 donations right after the shooting.

Unfortunately, 137 of these donations (17%) went unused and were subsequently discarded, compared to an average of 26 wasted donations per month at the blood bank.

Therefore, Dr. Lozada and his colleagues concluded that a call for immediate blood donation was unnecessary.

“There is an emotional desire after these events on the part of the public to immediately donate blood, but that’s not always necessary, and it’s not always the best immediate response,” Dr. Lozada said. “The best thing you can do is donate blood year-round.”

“One of the things that we propose in the paper is for cities to develop some protocols for these kind of scenarios, where instead of issuing a blanket call for blood donation, you would do it in a systematic way. As one suggestion, you might do it by ZIP code.”

“Our findings are important to help us prepare for the next mass shooting in the United States. It shows us the amount of blood components we likely will need. It will also help first responders adequately prepare to save lives.”

There was no funding for this research, and the study authors declared no conflicts of interest.

Photo from UAB Hospital

Public calls for blood donations in response to mass shootings may be unnecessary and result in waste, according to researchers.

Mass shootings often trigger a sharp increase in blood donations for affected communities.

In response to the recent mass shooting at the Tree Of Life Synagogue in Pittsburgh, Pennsylvania, multiple news outlets called for blood donations, and local blood centers extended their hours to compensate for the increase in donations.

However, a new study suggests that blood products donated in response to mass shootings may go unused and have to be discarded.

This study was published in The Journal of Trauma and Acute Care Surgery.

The study authors focused on blood donated in response to the mass shooting that took place in Las Vegas on October 1, 2017. This shooting resulted in 58 deaths, 869 injuries, 220 hospital admissions, and at least 68 critical care admissions.

Three healthcare systems provided data for the study. In all, 519 shooting victims were treated within these systems, and 185 were admitted to the hospitals. During the first 24 hours, these patients received 499 blood components, or 2.7 units per admission.

“From our data, it is likely that the total 1-day blood component transfusions needed in Las Vegas were more than in any mass shooting on record,” said study author M. James Lozada, DO, of Vanderbilt University Medical Center in Nashville, Tennessee.

However, the blood donations made in response to the shooting surpassed the need.

A public call for blood donations was issued during a press conference in the early hours of October 2, and that call was amplified in news stories. Stories about blood donation in Las Vegas increased from a daily average of 10 to more than 100 on October 2.

From October 2 to 4, the American Red Cross saw a 53% increase in blood donations nationwide.

The Las Vegas blood bank, United Blood Services, reported receiving 791 donations right after the shooting.

Unfortunately, 137 of these donations (17%) went unused and were subsequently discarded, compared to an average of 26 wasted donations per month at the blood bank.

Therefore, Dr. Lozada and his colleagues concluded that a call for immediate blood donation was unnecessary.

“There is an emotional desire after these events on the part of the public to immediately donate blood, but that’s not always necessary, and it’s not always the best immediate response,” Dr. Lozada said. “The best thing you can do is donate blood year-round.”

“One of the things that we propose in the paper is for cities to develop some protocols for these kind of scenarios, where instead of issuing a blanket call for blood donation, you would do it in a systematic way. As one suggestion, you might do it by ZIP code.”

“Our findings are important to help us prepare for the next mass shooting in the United States. It shows us the amount of blood components we likely will need. It will also help first responders adequately prepare to save lives.”

There was no funding for this research, and the study authors declared no conflicts of interest.

Photo from UAB Hospital

Public calls for blood donations in response to mass shootings may be unnecessary and result in waste, according to researchers.

Mass shootings often trigger a sharp increase in blood donations for affected communities.

In response to the recent mass shooting at the Tree Of Life Synagogue in Pittsburgh, Pennsylvania, multiple news outlets called for blood donations, and local blood centers extended their hours to compensate for the increase in donations.

However, a new study suggests that blood products donated in response to mass shootings may go unused and have to be discarded.

This study was published in The Journal of Trauma and Acute Care Surgery.

The study authors focused on blood donated in response to the mass shooting that took place in Las Vegas on October 1, 2017. This shooting resulted in 58 deaths, 869 injuries, 220 hospital admissions, and at least 68 critical care admissions.

Three healthcare systems provided data for the study. In all, 519 shooting victims were treated within these systems, and 185 were admitted to the hospitals. During the first 24 hours, these patients received 499 blood components, or 2.7 units per admission.

“From our data, it is likely that the total 1-day blood component transfusions needed in Las Vegas were more than in any mass shooting on record,” said study author M. James Lozada, DO, of Vanderbilt University Medical Center in Nashville, Tennessee.

However, the blood donations made in response to the shooting surpassed the need.

A public call for blood donations was issued during a press conference in the early hours of October 2, and that call was amplified in news stories. Stories about blood donation in Las Vegas increased from a daily average of 10 to more than 100 on October 2.

From October 2 to 4, the American Red Cross saw a 53% increase in blood donations nationwide.

The Las Vegas blood bank, United Blood Services, reported receiving 791 donations right after the shooting.

Unfortunately, 137 of these donations (17%) went unused and were subsequently discarded, compared to an average of 26 wasted donations per month at the blood bank.

Therefore, Dr. Lozada and his colleagues concluded that a call for immediate blood donation was unnecessary.

“There is an emotional desire after these events on the part of the public to immediately donate blood, but that’s not always necessary, and it’s not always the best immediate response,” Dr. Lozada said. “The best thing you can do is donate blood year-round.”

“One of the things that we propose in the paper is for cities to develop some protocols for these kind of scenarios, where instead of issuing a blanket call for blood donation, you would do it in a systematic way. As one suggestion, you might do it by ZIP code.”

“Our findings are important to help us prepare for the next mass shooting in the United States. It shows us the amount of blood components we likely will need. It will also help first responders adequately prepare to save lives.”

There was no funding for this research, and the study authors declared no conflicts of interest.

Photo from Durham University, Medical Detection Dogs, and London School of Hygiene & Tropical Medicine

NEW ORLEANS—Dogs can be trained to sniff out malaria in humans, according to research presented at the American Society of Tropical Medicine and Hygiene Annual Meeting.

Researchers found that dogs could detect malaria by sniffing socks worn by children from a malaria-endemic area of West Africa.

“While our findings are at an early stage, in principle, we have shown that dogs could be trained to detect malaria-infected people by their odor with a credible degree of accuracy,” said study investigator Steve Lindsay, PhD, of Durham University in Durham City, U.K.

Dr. Lindsay presented these findings at the meeting as abstract 32.

The research began in The Gambia, where 600 school children were recruited to join the study. They were checked for overall general health, sampled for malaria parasites, and fitted with a pair of socks they were asked to wear overnight.

The next day, the socks were collected. The socks were sorted according to the malaria infection status of the children. The researchers only selected socks from uninfected children and children with malaria who did not have fever.

The socks were shipped to the United Kingdom, where they were stored in a freezer for several months while dogs were trained to sniff out malaria.

The dogs had to distinguish between socks from children with malaria parasites and socks from uninfected children. The animals were trained to sniff each sample, freeze if they thought they detected malaria, and move on if they did not.

In total, 175 sock samples were tested, including those from 30 malaria-positive children and those from 145 uninfected children.

The dogs correctly identified 70% of the infected children and 90% of the uninfected children.

Dr. Lindsay and his colleagues believe that, with more training and more samples, the dogs could provide a level of accuracy approaching that of a clinical test.

Now, the researchers are considering a follow-up study that would take samples from people in different parts of Africa to test whether parasites from one part of the continent present odors that are different from another part of the continent.

As for putting malaria-detecting dogs to work in the field, Dr. Lindsay said they could be helpful assistants in malaria elimination campaigns.

Currently, the only way to address the problem of asymptomatic malaria carriers is to test or treat an entire community. Dr. Lindsay said detection dogs could be useful for significantly narrowing the focus of clinical testing and treatment efforts.

Dr. Lindsay also believes detection dogs could be used at ports of entry into countries that have eliminated malaria or are close to elimination.

“This could provide a non-invasive way of screening for the disease at ports of entry in a similar way to how sniffer dogs are routinely used to detect fruit and vegetables or drugs at airports,” he said.

“This could help prevent the spread of malaria to countries that have been declared malaria-free and also ensure that people, many of whom might be unaware that they are infected with the malaria parasite, receive antimalarial drug treatment for the disease.”

Dr. Lindsay and his colleagues’ research was funded by the Bill & Melinda Gates Foundation. Dr. Lindsay reported no conflicts of interest.

Photo from Durham University, Medical Detection Dogs, and London School of Hygiene & Tropical Medicine

NEW ORLEANS—Dogs can be trained to sniff out malaria in humans, according to research presented at the American Society of Tropical Medicine and Hygiene Annual Meeting.

Researchers found that dogs could detect malaria by sniffing socks worn by children from a malaria-endemic area of West Africa.

“While our findings are at an early stage, in principle, we have shown that dogs could be trained to detect malaria-infected people by their odor with a credible degree of accuracy,” said study investigator Steve Lindsay, PhD, of Durham University in Durham City, U.K.

Dr. Lindsay presented these findings at the meeting as abstract 32.

The research began in The Gambia, where 600 school children were recruited to join the study. They were checked for overall general health, sampled for malaria parasites, and fitted with a pair of socks they were asked to wear overnight.

The next day, the socks were collected. The socks were sorted according to the malaria infection status of the children. The researchers only selected socks from uninfected children and children with malaria who did not have fever.

The socks were shipped to the United Kingdom, where they were stored in a freezer for several months while dogs were trained to sniff out malaria.

The dogs had to distinguish between socks from children with malaria parasites and socks from uninfected children. The animals were trained to sniff each sample, freeze if they thought they detected malaria, and move on if they did not.

In total, 175 sock samples were tested, including those from 30 malaria-positive children and those from 145 uninfected children.

The dogs correctly identified 70% of the infected children and 90% of the uninfected children.

Dr. Lindsay and his colleagues believe that, with more training and more samples, the dogs could provide a level of accuracy approaching that of a clinical test.

Now, the researchers are considering a follow-up study that would take samples from people in different parts of Africa to test whether parasites from one part of the continent present odors that are different from another part of the continent.

As for putting malaria-detecting dogs to work in the field, Dr. Lindsay said they could be helpful assistants in malaria elimination campaigns.

Currently, the only way to address the problem of asymptomatic malaria carriers is to test or treat an entire community. Dr. Lindsay said detection dogs could be useful for significantly narrowing the focus of clinical testing and treatment efforts.

Dr. Lindsay also believes detection dogs could be used at ports of entry into countries that have eliminated malaria or are close to elimination.

“This could provide a non-invasive way of screening for the disease at ports of entry in a similar way to how sniffer dogs are routinely used to detect fruit and vegetables or drugs at airports,” he said.

“This could help prevent the spread of malaria to countries that have been declared malaria-free and also ensure that people, many of whom might be unaware that they are infected with the malaria parasite, receive antimalarial drug treatment for the disease.”

Dr. Lindsay and his colleagues’ research was funded by the Bill & Melinda Gates Foundation. Dr. Lindsay reported no conflicts of interest.

Photo from Durham University, Medical Detection Dogs, and London School of Hygiene & Tropical Medicine

NEW ORLEANS—Dogs can be trained to sniff out malaria in humans, according to research presented at the American Society of Tropical Medicine and Hygiene Annual Meeting.

Researchers found that dogs could detect malaria by sniffing socks worn by children from a malaria-endemic area of West Africa.

“While our findings are at an early stage, in principle, we have shown that dogs could be trained to detect malaria-infected people by their odor with a credible degree of accuracy,” said study investigator Steve Lindsay, PhD, of Durham University in Durham City, U.K.

Dr. Lindsay presented these findings at the meeting as abstract 32.

The research began in The Gambia, where 600 school children were recruited to join the study. They were checked for overall general health, sampled for malaria parasites, and fitted with a pair of socks they were asked to wear overnight.

The next day, the socks were collected. The socks were sorted according to the malaria infection status of the children. The researchers only selected socks from uninfected children and children with malaria who did not have fever.

The socks were shipped to the United Kingdom, where they were stored in a freezer for several months while dogs were trained to sniff out malaria.

The dogs had to distinguish between socks from children with malaria parasites and socks from uninfected children. The animals were trained to sniff each sample, freeze if they thought they detected malaria, and move on if they did not.

In total, 175 sock samples were tested, including those from 30 malaria-positive children and those from 145 uninfected children.

The dogs correctly identified 70% of the infected children and 90% of the uninfected children.

Dr. Lindsay and his colleagues believe that, with more training and more samples, the dogs could provide a level of accuracy approaching that of a clinical test.

Now, the researchers are considering a follow-up study that would take samples from people in different parts of Africa to test whether parasites from one part of the continent present odors that are different from another part of the continent.

As for putting malaria-detecting dogs to work in the field, Dr. Lindsay said they could be helpful assistants in malaria elimination campaigns.

Currently, the only way to address the problem of asymptomatic malaria carriers is to test or treat an entire community. Dr. Lindsay said detection dogs could be useful for significantly narrowing the focus of clinical testing and treatment efforts.

Dr. Lindsay also believes detection dogs could be used at ports of entry into countries that have eliminated malaria or are close to elimination.

“This could provide a non-invasive way of screening for the disease at ports of entry in a similar way to how sniffer dogs are routinely used to detect fruit and vegetables or drugs at airports,” he said.

“This could help prevent the spread of malaria to countries that have been declared malaria-free and also ensure that people, many of whom might be unaware that they are infected with the malaria parasite, receive antimalarial drug treatment for the disease.”

Dr. Lindsay and his colleagues’ research was funded by the Bill & Melinda Gates Foundation. Dr. Lindsay reported no conflicts of interest.

SAN ANTONIO – Understanding the experience of “moral distress” in critical care is essential because of its potential negative effects on health care providers and the need to prevent or address those effects, according to Marian Altman, PhD, RN, a clinical practice specialist from the American Association of Critical Care Nurses.

Tara Haelle/MDedge News

Dr. Altman spoke about moral distress as part of a panel discussion at the annual meeting of the American College of Chest Physicians on how to handle nonbeneficial treatment requests from families, including the legal and ethical obligations of care providers when a patient is receiving life-sustaining treatment.

“The key point about moral distress is that these are personal constraints, and so the choices of what is best for a patient often conflicts with what is best for the organization,” Dr. Altman told CHEST 2018 attendees. “It could conflict with what’s best for the care providers, the family, or even other patients, and so it’s that personal experience of moral compromise that often originates in this broader practice of our routine.”

While it does not necessarily occur frequently, moral distress is intense when it does occur.

“It really threatens the identity and the integrity of those who experience it because they truly believe they are seriously compromised with this deep personal effect,” Dr. Altman said.

Dr. Altman credited Andrew Jameton, a bioethicist who authored a seminal book on ethical issues in nursing in 1984, with defining exactly what moral distress is: “painful feelings and/or the psychological disequilibrium that occurs when a person is conscious of the morally appropriate action a situation requires but cannot carry out that action because of the institutionalized obstacles, such as lack of time, lack of supervisory support, exercise of medical power, and institutional policy or legal limits.” Or, in plainer terms, “Moral distress occurs when one knows the ethically correct action to take but feels powerless to take that action,” as Elizabeth G. Epstein, PhD, RN, and Sarah Delgado, MSN, RN, wrote in the Online Journal of Issues in Nursing.

To understand moral distress, it’s important to know what it’s not, too, Dr. Altman said. It’s not the daily stress of work or compassion fatigue or even burnout, though it can lead to burnout.

“Burnout is the state of physical, emotional, and mental fatigue and exhaustion caused by long-term involvement in situations that are emotionally demanding,” Dr. Altman said. “Burnout has been linked with moral distress, but they are two very different things.”

It’s also not a disagreement among colleagues or “an excuse to avoid a challenging situation.” In fact, the No. 1 cause of moral distress, in study after study, Dr. Altman said, is providing medical care, particularly medically futile care.

“Providing really unnecessary treatments and providing end-of-life care can lead to it as well as complex patients and challenging situations,” Dr. Altman said. Other causes include inadequate staffing, incompetent providers, poor communication, and advanced technology used to sustain life.

Though people often associate moral distress with intensive care, it can occur “wherever care is provided” and can “affect all members of the health care team,” Dr. Altman said. Though the early research into moral distress focused on critical care nurses, the field has since exploded, across all medical disciplines and in countries around the world.

That research has revealed how intensely moral distress can impact the psychological, biological, and social health of people. Physical symptoms that can result from moral distress include diarrhea, headache, heart palpitations, neck pain, muscle aches, and vomiting. The emotions it rouses include frustration, fear, anger, anxiety, and, especially, powerlessness and guilt.

Moral distress can lead to burnout and dissatisfaction in individuals and, subsequently, reduced retention and productivity within institutions. Health care providers who experience moral distress may leave their position, their unit, or the profession altogether.

“That can have a huge impact in a time when we need many more health care providers to care for this exploding population,” Dr. Altman said. It can also negatively influence the patient-provider relationship, potentially affecting the quantity and safety of care delivered, she explained.

But there are ways to address moral distress, she said.

“We’re not going to eradicate it because we will never eradicate critical care or end-of-life care, and those are the causes that lead to moral distress,” Dr. Altman said. “But what we can do, and what the research is now focusing on, is concentrate on improving our work environment, and help people recognize that they’re experiencing moral distress before it gets to burnout … or mitigating moral distress when it occurs.”

Those improvements include fostering both a positive ethical environment, with ethics education, an ethics committee, and on-site ethics experts, and a healthy work environment with collaboration and skillful communication.

Research has shown that “a higher ethical work environment is correlated with a decrease in moral distress frequency,” Dr. Altman said. And structured communication processes should focus on the goals of care, she said. More formal programs may include moral distress workshops, a moral distress consult service, an ethics consult service, and distress debriefings, during which a facilitator leads providers in a structured, collaborative discussion about a distressing event that has occurred.

SAN ANTONIO – Understanding the experience of “moral distress” in critical care is essential because of its potential negative effects on health care providers and the need to prevent or address those effects, according to Marian Altman, PhD, RN, a clinical practice specialist from the American Association of Critical Care Nurses.

Tara Haelle/MDedge News

Dr. Altman spoke about moral distress as part of a panel discussion at the annual meeting of the American College of Chest Physicians on how to handle nonbeneficial treatment requests from families, including the legal and ethical obligations of care providers when a patient is receiving life-sustaining treatment.

“The key point about moral distress is that these are personal constraints, and so the choices of what is best for a patient often conflicts with what is best for the organization,” Dr. Altman told CHEST 2018 attendees. “It could conflict with what’s best for the care providers, the family, or even other patients, and so it’s that personal experience of moral compromise that often originates in this broader practice of our routine.”

While it does not necessarily occur frequently, moral distress is intense when it does occur.

“It really threatens the identity and the integrity of those who experience it because they truly believe they are seriously compromised with this deep personal effect,” Dr. Altman said.

Dr. Altman credited Andrew Jameton, a bioethicist who authored a seminal book on ethical issues in nursing in 1984, with defining exactly what moral distress is: “painful feelings and/or the psychological disequilibrium that occurs when a person is conscious of the morally appropriate action a situation requires but cannot carry out that action because of the institutionalized obstacles, such as lack of time, lack of supervisory support, exercise of medical power, and institutional policy or legal limits.” Or, in plainer terms, “Moral distress occurs when one knows the ethically correct action to take but feels powerless to take that action,” as Elizabeth G. Epstein, PhD, RN, and Sarah Delgado, MSN, RN, wrote in the Online Journal of Issues in Nursing.

To understand moral distress, it’s important to know what it’s not, too, Dr. Altman said. It’s not the daily stress of work or compassion fatigue or even burnout, though it can lead to burnout.

“Burnout is the state of physical, emotional, and mental fatigue and exhaustion caused by long-term involvement in situations that are emotionally demanding,” Dr. Altman said. “Burnout has been linked with moral distress, but they are two very different things.”

It’s also not a disagreement among colleagues or “an excuse to avoid a challenging situation.” In fact, the No. 1 cause of moral distress, in study after study, Dr. Altman said, is providing medical care, particularly medically futile care.

“Providing really unnecessary treatments and providing end-of-life care can lead to it as well as complex patients and challenging situations,” Dr. Altman said. Other causes include inadequate staffing, incompetent providers, poor communication, and advanced technology used to sustain life.

Though people often associate moral distress with intensive care, it can occur “wherever care is provided” and can “affect all members of the health care team,” Dr. Altman said. Though the early research into moral distress focused on critical care nurses, the field has since exploded, across all medical disciplines and in countries around the world.

That research has revealed how intensely moral distress can impact the psychological, biological, and social health of people. Physical symptoms that can result from moral distress include diarrhea, headache, heart palpitations, neck pain, muscle aches, and vomiting. The emotions it rouses include frustration, fear, anger, anxiety, and, especially, powerlessness and guilt.

Moral distress can lead to burnout and dissatisfaction in individuals and, subsequently, reduced retention and productivity within institutions. Health care providers who experience moral distress may leave their position, their unit, or the profession altogether.

“That can have a huge impact in a time when we need many more health care providers to care for this exploding population,” Dr. Altman said. It can also negatively influence the patient-provider relationship, potentially affecting the quantity and safety of care delivered, she explained.

But there are ways to address moral distress, she said.

“We’re not going to eradicate it because we will never eradicate critical care or end-of-life care, and those are the causes that lead to moral distress,” Dr. Altman said. “But what we can do, and what the research is now focusing on, is concentrate on improving our work environment, and help people recognize that they’re experiencing moral distress before it gets to burnout … or mitigating moral distress when it occurs.”

Those improvements include fostering both a positive ethical environment, with ethics education, an ethics committee, and on-site ethics experts, and a healthy work environment with collaboration and skillful communication.

Research has shown that “a higher ethical work environment is correlated with a decrease in moral distress frequency,” Dr. Altman said. And structured communication processes should focus on the goals of care, she said. More formal programs may include moral distress workshops, a moral distress consult service, an ethics consult service, and distress debriefings, during which a facilitator leads providers in a structured, collaborative discussion about a distressing event that has occurred.

SAN ANTONIO – Understanding the experience of “moral distress” in critical care is essential because of its potential negative effects on health care providers and the need to prevent or address those effects, according to Marian Altman, PhD, RN, a clinical practice specialist from the American Association of Critical Care Nurses.

Tara Haelle/MDedge News

Dr. Altman spoke about moral distress as part of a panel discussion at the annual meeting of the American College of Chest Physicians on how to handle nonbeneficial treatment requests from families, including the legal and ethical obligations of care providers when a patient is receiving life-sustaining treatment.

“The key point about moral distress is that these are personal constraints, and so the choices of what is best for a patient often conflicts with what is best for the organization,” Dr. Altman told CHEST 2018 attendees. “It could conflict with what’s best for the care providers, the family, or even other patients, and so it’s that personal experience of moral compromise that often originates in this broader practice of our routine.”

While it does not necessarily occur frequently, moral distress is intense when it does occur.

“It really threatens the identity and the integrity of those who experience it because they truly believe they are seriously compromised with this deep personal effect,” Dr. Altman said.

Dr. Altman credited Andrew Jameton, a bioethicist who authored a seminal book on ethical issues in nursing in 1984, with defining exactly what moral distress is: “painful feelings and/or the psychological disequilibrium that occurs when a person is conscious of the morally appropriate action a situation requires but cannot carry out that action because of the institutionalized obstacles, such as lack of time, lack of supervisory support, exercise of medical power, and institutional policy or legal limits.” Or, in plainer terms, “Moral distress occurs when one knows the ethically correct action to take but feels powerless to take that action,” as Elizabeth G. Epstein, PhD, RN, and Sarah Delgado, MSN, RN, wrote in the Online Journal of Issues in Nursing.

To understand moral distress, it’s important to know what it’s not, too, Dr. Altman said. It’s not the daily stress of work or compassion fatigue or even burnout, though it can lead to burnout.

“Burnout is the state of physical, emotional, and mental fatigue and exhaustion caused by long-term involvement in situations that are emotionally demanding,” Dr. Altman said. “Burnout has been linked with moral distress, but they are two very different things.”

It’s also not a disagreement among colleagues or “an excuse to avoid a challenging situation.” In fact, the No. 1 cause of moral distress, in study after study, Dr. Altman said, is providing medical care, particularly medically futile care.

“Providing really unnecessary treatments and providing end-of-life care can lead to it as well as complex patients and challenging situations,” Dr. Altman said. Other causes include inadequate staffing, incompetent providers, poor communication, and advanced technology used to sustain life.

Though people often associate moral distress with intensive care, it can occur “wherever care is provided” and can “affect all members of the health care team,” Dr. Altman said. Though the early research into moral distress focused on critical care nurses, the field has since exploded, across all medical disciplines and in countries around the world.

That research has revealed how intensely moral distress can impact the psychological, biological, and social health of people. Physical symptoms that can result from moral distress include diarrhea, headache, heart palpitations, neck pain, muscle aches, and vomiting. The emotions it rouses include frustration, fear, anger, anxiety, and, especially, powerlessness and guilt.

Moral distress can lead to burnout and dissatisfaction in individuals and, subsequently, reduced retention and productivity within institutions. Health care providers who experience moral distress may leave their position, their unit, or the profession altogether.

“That can have a huge impact in a time when we need many more health care providers to care for this exploding population,” Dr. Altman said. It can also negatively influence the patient-provider relationship, potentially affecting the quantity and safety of care delivered, she explained.

But there are ways to address moral distress, she said.

“We’re not going to eradicate it because we will never eradicate critical care or end-of-life care, and those are the causes that lead to moral distress,” Dr. Altman said. “But what we can do, and what the research is now focusing on, is concentrate on improving our work environment, and help people recognize that they’re experiencing moral distress before it gets to burnout … or mitigating moral distress when it occurs.”

Those improvements include fostering both a positive ethical environment, with ethics education, an ethics committee, and on-site ethics experts, and a healthy work environment with collaboration and skillful communication.

Research has shown that “a higher ethical work environment is correlated with a decrease in moral distress frequency,” Dr. Altman said. And structured communication processes should focus on the goals of care, she said. More formal programs may include moral distress workshops, a moral distress consult service, an ethics consult service, and distress debriefings, during which a facilitator leads providers in a structured, collaborative discussion about a distressing event that has occurred.

BOSTON – The success of surgical safety checklists to reduce postoperative mortality appears to depend not only on implementation but also on the degree to which a hospital embraces a culture of teamwork, Atul Gawande, MD, MPH, FACS, said at the annual clinical congress of the American College of Surgeons.

copyright/Lifebox/Marco Carraro 

The session “Checking in on the Checklist – Ten Years of the WHO Surgical Safety Checklist” moderated by Thomas Geoghegan Weiser, MD, FACS, and Alex B. Haynes, MD, FACS,considered the progress of the past decade in implementing the World Health Organization initiative in medical institutions around the world.

Team-based approaches to the checklist accompanied by other institutional support have demonstrated double-digit reductions in mortality, while in contrast, a mandate-only approach resulted in a 0% change, said Dr. Gawande, a general and endocrine surgeon at Brigham and Women’s Hospital and professor in the department of health policy and management at the Harvard T.H. Chan School of Public Health and the Samuel O. Thier Professor of Surgery at Harvard Medical School, all in Boston.

Variables including respect among team members, clinical leadership, and assertiveness on behalf of patient safety appeared to be predictive of postoperative death rates in one recent implementation of the WHO Surgical Safety Checklist, he added.

Dr. Gawande said the 29-item surgical safety checklist has earned support but also skepticism and “some outright opposition” in the nearly 10 years since landmark study published in the New England Journal of Medicine, coauthored by Dr. Haynes, reported that the approach cut mortality by 47% and postoperative complication rates by 36%, on average, in a diverse group of eight hospitals throughout the world.

“It’s a challenge in a fundamental way, to our values,” Dr. Gawande told attendees. “What we have valued in our life as surgeons is our autonomy as clinicians, and here was an approach which required you to work with different values: humility, discipline, teamwork.”

That 47% mortality reduction was achieved in a clinical trial setting with “very carefully selected sites” that were enthusiastic about giving the checklist a try, and toward that end, received weekly support, Dr. Gawande said.

Subsequent implementations of the checklist have had varying success rates, he said.

Implementations that have included a mandate plus regular feedback have yielded mortality reductions upward of 26%he said, while a mandate plus team training reduced mortality by 18% in a Veterans Health Administration hospital setting, according to Dr. Gawande. By contrast, a mandate-alone approach in Ontario yielded a 0% reduction in mortality.

“What we came to realize is a kind of formula that underlies how you create change in organizations generally, where you’re trying to create systems that make it easier for people to get the right kinds of things done,” Dr. Gawande said.

“You have a systems tool that has been carefully crafted around the ‘killer items’ – the failure points that even experts fail at – you have an implementation pathway, and then you bring it into a ready environment where people are capable and they’re motivated,” he explained.

A South Carolina initiative that was voluntary and included light-touch support yielded a 22% reduction in hospitals that completed the adoption program, Dr. Gawande said. Of note, investigators in the Safe Surgery 2015: South Carolina Initiative found that perceptions of safety among operating room personnel were associated with the all-cause 30-day postoperative death rate.

“The team found in South Carolina that the predictor of how much change you get is how effective your implementation was in changing the culture to be more team oriented,” Dr. Gawande said.

“You could recognize it by how much change you saw in what the frontline people reported about how much they are respected, how much clinical leadership was actually involved in the way the team works, and the ultimate test; how assertive could people be in raising issues,” he continued. “Did they feel safe to raise issues, and not get their head bitten off, but in fact, find that what they offered had value.”

Dr. Gawande is the founder and executive director of Ariadne Labs, a center for health systems innovation, and the chairman of Lifebox, a not-for-profit organization.

SOURCE: Gawande AA et al. ACS Clinical Congress 2018, Session PS232.

BOSTON – The success of surgical safety checklists to reduce postoperative mortality appears to depend not only on implementation but also on the degree to which a hospital embraces a culture of teamwork, Atul Gawande, MD, MPH, FACS, said at the annual clinical congress of the American College of Surgeons.

copyright/Lifebox/Marco Carraro 

The session “Checking in on the Checklist – Ten Years of the WHO Surgical Safety Checklist” moderated by Thomas Geoghegan Weiser, MD, FACS, and Alex B. Haynes, MD, FACS,considered the progress of the past decade in implementing the World Health Organization initiative in medical institutions around the world.

Team-based approaches to the checklist accompanied by other institutional support have demonstrated double-digit reductions in mortality, while in contrast, a mandate-only approach resulted in a 0% change, said Dr. Gawande, a general and endocrine surgeon at Brigham and Women’s Hospital and professor in the department of health policy and management at the Harvard T.H. Chan School of Public Health and the Samuel O. Thier Professor of Surgery at Harvard Medical School, all in Boston.

Variables including respect among team members, clinical leadership, and assertiveness on behalf of patient safety appeared to be predictive of postoperative death rates in one recent implementation of the WHO Surgical Safety Checklist, he added.

Dr. Gawande said the 29-item surgical safety checklist has earned support but also skepticism and “some outright opposition” in the nearly 10 years since landmark study published in the New England Journal of Medicine, coauthored by Dr. Haynes, reported that the approach cut mortality by 47% and postoperative complication rates by 36%, on average, in a diverse group of eight hospitals throughout the world.

“It’s a challenge in a fundamental way, to our values,” Dr. Gawande told attendees. “What we have valued in our life as surgeons is our autonomy as clinicians, and here was an approach which required you to work with different values: humility, discipline, teamwork.”

That 47% mortality reduction was achieved in a clinical trial setting with “very carefully selected sites” that were enthusiastic about giving the checklist a try, and toward that end, received weekly support, Dr. Gawande said.

Subsequent implementations of the checklist have had varying success rates, he said.

Implementations that have included a mandate plus regular feedback have yielded mortality reductions upward of 26%he said, while a mandate plus team training reduced mortality by 18% in a Veterans Health Administration hospital setting, according to Dr. Gawande. By contrast, a mandate-alone approach in Ontario yielded a 0% reduction in mortality.

“What we came to realize is a kind of formula that underlies how you create change in organizations generally, where you’re trying to create systems that make it easier for people to get the right kinds of things done,” Dr. Gawande said.

“You have a systems tool that has been carefully crafted around the ‘killer items’ – the failure points that even experts fail at – you have an implementation pathway, and then you bring it into a ready environment where people are capable and they’re motivated,” he explained.

A South Carolina initiative that was voluntary and included light-touch support yielded a 22% reduction in hospitals that completed the adoption program, Dr. Gawande said. Of note, investigators in the Safe Surgery 2015: South Carolina Initiative found that perceptions of safety among operating room personnel were associated with the all-cause 30-day postoperative death rate.

“The team found in South Carolina that the predictor of how much change you get is how effective your implementation was in changing the culture to be more team oriented,” Dr. Gawande said.

“You could recognize it by how much change you saw in what the frontline people reported about how much they are respected, how much clinical leadership was actually involved in the way the team works, and the ultimate test; how assertive could people be in raising issues,” he continued. “Did they feel safe to raise issues, and not get their head bitten off, but in fact, find that what they offered had value.”

Dr. Gawande is the founder and executive director of Ariadne Labs, a center for health systems innovation, and the chairman of Lifebox, a not-for-profit organization.

SOURCE: Gawande AA et al. ACS Clinical Congress 2018, Session PS232.

BOSTON – The success of surgical safety checklists to reduce postoperative mortality appears to depend not only on implementation but also on the degree to which a hospital embraces a culture of teamwork, Atul Gawande, MD, MPH, FACS, said at the annual clinical congress of the American College of Surgeons.

copyright/Lifebox/Marco Carraro 

The session “Checking in on the Checklist – Ten Years of the WHO Surgical Safety Checklist” moderated by Thomas Geoghegan Weiser, MD, FACS, and Alex B. Haynes, MD, FACS,considered the progress of the past decade in implementing the World Health Organization initiative in medical institutions around the world.

Team-based approaches to the checklist accompanied by other institutional support have demonstrated double-digit reductions in mortality, while in contrast, a mandate-only approach resulted in a 0% change, said Dr. Gawande, a general and endocrine surgeon at Brigham and Women’s Hospital and professor in the department of health policy and management at the Harvard T.H. Chan School of Public Health and the Samuel O. Thier Professor of Surgery at Harvard Medical School, all in Boston.

Variables including respect among team members, clinical leadership, and assertiveness on behalf of patient safety appeared to be predictive of postoperative death rates in one recent implementation of the WHO Surgical Safety Checklist, he added.

Dr. Gawande said the 29-item surgical safety checklist has earned support but also skepticism and “some outright opposition” in the nearly 10 years since landmark study published in the New England Journal of Medicine, coauthored by Dr. Haynes, reported that the approach cut mortality by 47% and postoperative complication rates by 36%, on average, in a diverse group of eight hospitals throughout the world.

“It’s a challenge in a fundamental way, to our values,” Dr. Gawande told attendees. “What we have valued in our life as surgeons is our autonomy as clinicians, and here was an approach which required you to work with different values: humility, discipline, teamwork.”

That 47% mortality reduction was achieved in a clinical trial setting with “very carefully selected sites” that were enthusiastic about giving the checklist a try, and toward that end, received weekly support, Dr. Gawande said.

Subsequent implementations of the checklist have had varying success rates, he said.

Implementations that have included a mandate plus regular feedback have yielded mortality reductions upward of 26%he said, while a mandate plus team training reduced mortality by 18% in a Veterans Health Administration hospital setting, according to Dr. Gawande. By contrast, a mandate-alone approach in Ontario yielded a 0% reduction in mortality.

“What we came to realize is a kind of formula that underlies how you create change in organizations generally, where you’re trying to create systems that make it easier for people to get the right kinds of things done,” Dr. Gawande said.

“You have a systems tool that has been carefully crafted around the ‘killer items’ – the failure points that even experts fail at – you have an implementation pathway, and then you bring it into a ready environment where people are capable and they’re motivated,” he explained.

A South Carolina initiative that was voluntary and included light-touch support yielded a 22% reduction in hospitals that completed the adoption program, Dr. Gawande said. Of note, investigators in the Safe Surgery 2015: South Carolina Initiative found that perceptions of safety among operating room personnel were associated with the all-cause 30-day postoperative death rate.

“The team found in South Carolina that the predictor of how much change you get is how effective your implementation was in changing the culture to be more team oriented,” Dr. Gawande said.

“You could recognize it by how much change you saw in what the frontline people reported about how much they are respected, how much clinical leadership was actually involved in the way the team works, and the ultimate test; how assertive could people be in raising issues,” he continued. “Did they feel safe to raise issues, and not get their head bitten off, but in fact, find that what they offered had value.”

Dr. Gawande is the founder and executive director of Ariadne Labs, a center for health systems innovation, and the chairman of Lifebox, a not-for-profit organization.

SOURCE: Gawande AA et al. ACS Clinical Congress 2018, Session PS232.