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EHA creates ‘roadmap’ for hematology research
Photo by Daniel Sone
The European Hematology Association (EHA) has created a “roadmap” for hematology research in Europe.
This guidance document summarizes the current status of basic, translational, and clinical hematology research and identifies areas of unmet scientific and medical need in Europe.
It is intended to help European and national policy makers, funding agencies, charities, research institutes, and researchers make decisions on initiating, funding, or developing research.
The guidance, “The European Hematology Association Roadmap for European Hematology Research: A Consensus Document,” is published in this month’s issue of haematologica.
“For the first time, hematologists in Europe came together to develop a roadmap to guide hematology research in Europe” said Andreas Engert, MD, chair of the EHA Research Roadmap Task Force.
“Hematology in Europe has achieved a lot, but the discipline must focus and collaborate to be efficient and remain successful in improving patient outcomes. The roadmap does just that and will determine the research agenda in Europe in the coming years.”
Roughly 300 experts from more than 20 countries—including clinicians, basic researchers, and patients—contributed to the roadmap. Stakeholders such as national hematology societies, patient organizations, hematology trial groups, and other European organizations were consulted to comment on the final draft version.
The final roadmap has 9 sections: normal hematopoiesis, malignant lymphoid and myeloid diseases, anemias and related diseases, platelet disorders, blood coagulation and hemostatic disorders, transfusion medicine, infections in hematology, and hematopoietic stem cell transplantation.
The roadmap lists priorities and needs in these areas, including the need for targeted therapies based on genomic profiling and chemical biology, the need to eradicate minimal residual disease, and the need for treatments that are better tolerated by elderly patients.
“Now’s the time for Europe to pay attention,” said Ulrich Jäger, MD, chair of the EHA European Affairs Committee.
“With an aging population, the slow recovery from the financial and Euro crises, costly medical breakthroughs and innovations—quite a few of which involve hematology researchers—Europe faces increased health expenditures while budgets are limited.”
“Policy makers are rightfully cautious when spending the taxpayers’ money. So it is our responsibility to provide the policy makers with the information and evidence they need to decide where their support impacts knowledge and health most efficiently, to the benefit of patients and society. The Research Roadmap delivers on that. Now, it is up to the policy makers in the EU to deliver too.” 
Photo by Daniel Sone
The European Hematology Association (EHA) has created a “roadmap” for hematology research in Europe.
This guidance document summarizes the current status of basic, translational, and clinical hematology research and identifies areas of unmet scientific and medical need in Europe.
It is intended to help European and national policy makers, funding agencies, charities, research institutes, and researchers make decisions on initiating, funding, or developing research.
The guidance, “The European Hematology Association Roadmap for European Hematology Research: A Consensus Document,” is published in this month’s issue of haematologica.
“For the first time, hematologists in Europe came together to develop a roadmap to guide hematology research in Europe” said Andreas Engert, MD, chair of the EHA Research Roadmap Task Force.
“Hematology in Europe has achieved a lot, but the discipline must focus and collaborate to be efficient and remain successful in improving patient outcomes. The roadmap does just that and will determine the research agenda in Europe in the coming years.”
Roughly 300 experts from more than 20 countries—including clinicians, basic researchers, and patients—contributed to the roadmap. Stakeholders such as national hematology societies, patient organizations, hematology trial groups, and other European organizations were consulted to comment on the final draft version.
The final roadmap has 9 sections: normal hematopoiesis, malignant lymphoid and myeloid diseases, anemias and related diseases, platelet disorders, blood coagulation and hemostatic disorders, transfusion medicine, infections in hematology, and hematopoietic stem cell transplantation.
The roadmap lists priorities and needs in these areas, including the need for targeted therapies based on genomic profiling and chemical biology, the need to eradicate minimal residual disease, and the need for treatments that are better tolerated by elderly patients.
“Now’s the time for Europe to pay attention,” said Ulrich Jäger, MD, chair of the EHA European Affairs Committee.
“With an aging population, the slow recovery from the financial and Euro crises, costly medical breakthroughs and innovations—quite a few of which involve hematology researchers—Europe faces increased health expenditures while budgets are limited.”
“Policy makers are rightfully cautious when spending the taxpayers’ money. So it is our responsibility to provide the policy makers with the information and evidence they need to decide where their support impacts knowledge and health most efficiently, to the benefit of patients and society. The Research Roadmap delivers on that. Now, it is up to the policy makers in the EU to deliver too.”
Photo by Daniel Sone
The European Hematology Association (EHA) has created a “roadmap” for hematology research in Europe.
This guidance document summarizes the current status of basic, translational, and clinical hematology research and identifies areas of unmet scientific and medical need in Europe.
It is intended to help European and national policy makers, funding agencies, charities, research institutes, and researchers make decisions on initiating, funding, or developing research.
The guidance, “The European Hematology Association Roadmap for European Hematology Research: A Consensus Document,” is published in this month’s issue of haematologica.
“For the first time, hematologists in Europe came together to develop a roadmap to guide hematology research in Europe” said Andreas Engert, MD, chair of the EHA Research Roadmap Task Force.
“Hematology in Europe has achieved a lot, but the discipline must focus and collaborate to be efficient and remain successful in improving patient outcomes. The roadmap does just that and will determine the research agenda in Europe in the coming years.”
Roughly 300 experts from more than 20 countries—including clinicians, basic researchers, and patients—contributed to the roadmap. Stakeholders such as national hematology societies, patient organizations, hematology trial groups, and other European organizations were consulted to comment on the final draft version.
The final roadmap has 9 sections: normal hematopoiesis, malignant lymphoid and myeloid diseases, anemias and related diseases, platelet disorders, blood coagulation and hemostatic disorders, transfusion medicine, infections in hematology, and hematopoietic stem cell transplantation.
The roadmap lists priorities and needs in these areas, including the need for targeted therapies based on genomic profiling and chemical biology, the need to eradicate minimal residual disease, and the need for treatments that are better tolerated by elderly patients.
“Now’s the time for Europe to pay attention,” said Ulrich Jäger, MD, chair of the EHA European Affairs Committee.
“With an aging population, the slow recovery from the financial and Euro crises, costly medical breakthroughs and innovations—quite a few of which involve hematology researchers—Europe faces increased health expenditures while budgets are limited.”
“Policy makers are rightfully cautious when spending the taxpayers’ money. So it is our responsibility to provide the policy makers with the information and evidence they need to decide where their support impacts knowledge and health most efficiently, to the benefit of patients and society. The Research Roadmap delivers on that. Now, it is up to the policy makers in the EU to deliver too.”
When loved ones get cancer, people turn to the Web
chemotherapy
Photo by Rhoda Baer
Loved ones of cancer patients often turn to the Internet for further information about the disease, but they are less inclined to seek emotional support from social media forums, according to a study published in Computers, Informatics, Nursing.
It is fairly common for loved ones of cancer patients to develop depression or anxiety disorders as a result of the diagnosis, but there aren’t many studies focusing specifically on cancer patients’ caregivers and family members, said study author Carolyn Lauckner, PhD, of the University of Georgia in Athens.
“I think, sometimes, the loved ones and caregivers get forgotten about,” she said. “And that’s why I wanted to research this population to see if there are ways that we can better support these individuals.”
Dr Lauckner surveyed 191 people whose loved ones were diagnosed with cancer in the past year or who were currently acting as caregivers to someone with cancer. The motivation behind the research was personal for Dr Lauckner.
“I went through a period of time where I had 3 loved ones diagnosed within a short amount of time,” she said. “I had these experiences where I heard about the diagnosis and I would go online to look it up, and then I would immediately become terrified and freak out about all the stuff I read online.”
Like Dr Lauckner, more than 75% of the subjects she surveyed searched online for information on a loved one’s disease. Most looked for treatment options, prevention strategies and risk factors, and prognosis information.
“I was pleasantly surprised by the amount of people who said that they were looking for prevention information online and detection information,” Dr Lauckner said. “[T]hat shows that not only are they concerned for their loved one but they’re also concerned about how they themselves can avoid cancer, which, from a public health perspective, is great.”
Respondents were less inclined to view blogs or go online to hear about others’ cancer experiences. These kinds of sites were linked to negative emotions for participants, such as fear, sadness, and anger.
“A lot of people, especially in the cancer realm, they will use blogs or discussion posts to vent and to talk about the harsh realities of living with an illness,” Dr Lauckner said.
“And while I think that that is beneficial for both the person who is writing it and potentially for some people who want an idea of what to expect, when someone is dealing with the prospect of their loved one having to go through that experience, it can be extremely distressing.”
The most commonly visited websites were those of charitable organizations like the American Cancer Society, which were associated with positive emotions. Dr Lauckner said she found this information encouraging because it shows that participants were consulting reliable sources of information and not being swayed by personal accounts as much.
Dr Lauckner ultimately wants to build on the information gleaned in this study to determine the most effective use of social media and technology to distribute cancer prevention and risk reduction messages to the public.
chemotherapy
Photo by Rhoda Baer
Loved ones of cancer patients often turn to the Internet for further information about the disease, but they are less inclined to seek emotional support from social media forums, according to a study published in Computers, Informatics, Nursing.
It is fairly common for loved ones of cancer patients to develop depression or anxiety disorders as a result of the diagnosis, but there aren’t many studies focusing specifically on cancer patients’ caregivers and family members, said study author Carolyn Lauckner, PhD, of the University of Georgia in Athens.
“I think, sometimes, the loved ones and caregivers get forgotten about,” she said. “And that’s why I wanted to research this population to see if there are ways that we can better support these individuals.”
Dr Lauckner surveyed 191 people whose loved ones were diagnosed with cancer in the past year or who were currently acting as caregivers to someone with cancer. The motivation behind the research was personal for Dr Lauckner.
“I went through a period of time where I had 3 loved ones diagnosed within a short amount of time,” she said. “I had these experiences where I heard about the diagnosis and I would go online to look it up, and then I would immediately become terrified and freak out about all the stuff I read online.”
Like Dr Lauckner, more than 75% of the subjects she surveyed searched online for information on a loved one’s disease. Most looked for treatment options, prevention strategies and risk factors, and prognosis information.
“I was pleasantly surprised by the amount of people who said that they were looking for prevention information online and detection information,” Dr Lauckner said. “[T]hat shows that not only are they concerned for their loved one but they’re also concerned about how they themselves can avoid cancer, which, from a public health perspective, is great.”
Respondents were less inclined to view blogs or go online to hear about others’ cancer experiences. These kinds of sites were linked to negative emotions for participants, such as fear, sadness, and anger.
“A lot of people, especially in the cancer realm, they will use blogs or discussion posts to vent and to talk about the harsh realities of living with an illness,” Dr Lauckner said.
“And while I think that that is beneficial for both the person who is writing it and potentially for some people who want an idea of what to expect, when someone is dealing with the prospect of their loved one having to go through that experience, it can be extremely distressing.”
The most commonly visited websites were those of charitable organizations like the American Cancer Society, which were associated with positive emotions. Dr Lauckner said she found this information encouraging because it shows that participants were consulting reliable sources of information and not being swayed by personal accounts as much.
Dr Lauckner ultimately wants to build on the information gleaned in this study to determine the most effective use of social media and technology to distribute cancer prevention and risk reduction messages to the public.
chemotherapy
Photo by Rhoda Baer
Loved ones of cancer patients often turn to the Internet for further information about the disease, but they are less inclined to seek emotional support from social media forums, according to a study published in Computers, Informatics, Nursing.
It is fairly common for loved ones of cancer patients to develop depression or anxiety disorders as a result of the diagnosis, but there aren’t many studies focusing specifically on cancer patients’ caregivers and family members, said study author Carolyn Lauckner, PhD, of the University of Georgia in Athens.
“I think, sometimes, the loved ones and caregivers get forgotten about,” she said. “And that’s why I wanted to research this population to see if there are ways that we can better support these individuals.”
Dr Lauckner surveyed 191 people whose loved ones were diagnosed with cancer in the past year or who were currently acting as caregivers to someone with cancer. The motivation behind the research was personal for Dr Lauckner.
“I went through a period of time where I had 3 loved ones diagnosed within a short amount of time,” she said. “I had these experiences where I heard about the diagnosis and I would go online to look it up, and then I would immediately become terrified and freak out about all the stuff I read online.”
Like Dr Lauckner, more than 75% of the subjects she surveyed searched online for information on a loved one’s disease. Most looked for treatment options, prevention strategies and risk factors, and prognosis information.
“I was pleasantly surprised by the amount of people who said that they were looking for prevention information online and detection information,” Dr Lauckner said. “[T]hat shows that not only are they concerned for their loved one but they’re also concerned about how they themselves can avoid cancer, which, from a public health perspective, is great.”
Respondents were less inclined to view blogs or go online to hear about others’ cancer experiences. These kinds of sites were linked to negative emotions for participants, such as fear, sadness, and anger.
“A lot of people, especially in the cancer realm, they will use blogs or discussion posts to vent and to talk about the harsh realities of living with an illness,” Dr Lauckner said.
“And while I think that that is beneficial for both the person who is writing it and potentially for some people who want an idea of what to expect, when someone is dealing with the prospect of their loved one having to go through that experience, it can be extremely distressing.”
The most commonly visited websites were those of charitable organizations like the American Cancer Society, which were associated with positive emotions. Dr Lauckner said she found this information encouraging because it shows that participants were consulting reliable sources of information and not being swayed by personal accounts as much.
Dr Lauckner ultimately wants to build on the information gleaned in this study to determine the most effective use of social media and technology to distribute cancer prevention and risk reduction messages to the public.
Education may increase clinical trial participation
Photo courtesy of NCI
and Matthews Media Group
A new study suggests that educating cancer patients about clinical trials—with either a general or patient-specific program—increases the likelihood that patients will enroll in such trials.
After completing either type of educational program, 21% of the cancer patients studied chose to enroll in clinical trials.
Traditionally, less than 5% of cancer patients decide to participate in trials, according to the American Cancer Society.
“Unfortunately, although clinical trials are critical for advancing cancer treatment and ultimately serve as the basis for new standards of care, very few patients participate,” said Neal J. Meropol, MD, of Case Western Reserve University School of Medicine in Cleveland, Ohio.
“We want to close the patient knowledge gap and positively affect their attitudes toward clinical trials.”
Dr Meropol and his colleagues described their effort to do just that in the Journal of Clinical Oncology.
The researchers compared a tailored video education program on clinical trials, PRE-ACT (Preparatory Education about Clinical Trials), to educational information delivered as written text.
PRE-ACT is an intervention in which patients access a website to take an online survey. The survey gauges the individual patient’s knowledge and attitudes about clinical trials, and then, based on that patient’s answers, video clips are presented addressing his or her specific concerns.
For example, patients may worry they will receive a placebo rather than active treatment, so one video clip explains how placebos are used ethically in cancer studies, and the fact that very few studies will include a placebo without any active treatment. The videos also help patients clarify their preferences in terms of quality of life or length of life.
Results
Dr Meropol and his colleagues enrolled 1255 cancer patients in the study. Half of them participated in the PRE-ACT program, and the other half received written information about clinical trials that was not specifically chosen based on their survey responses.
Both interventions improved patients’ knowledge and attitudes regarding clinical trials when compared with baseline (all P<0.001).
Patients in both arms said they felt more prepared to consider enrolling in a clinical trial after completing their assigned educational program (P<0.001), but there was a trend favoring the PRE-ACT arm (P<0.09).
Patients in the PRE-ACT arm also showed a significantly greater increase in knowledge (P<0.001) and a significantly greater decrease in attitudinal barriers (P<0.001) than patients in the text-only arm. And PRE-ACT was associated with greater patient satisfaction.
Financial concerns
During the course of this research, Dr Meropol and his colleagues made a surprising discovery. Video clips meant to address concerns about the costs of clinical trial treatment actually caused a spike in worries about the out-of-pocket costs of clinical trials.
These financial concerns generated yet another paper that appeared in the same edition of the Journal of Clinical Oncology.
“What was a surprise is that giving people information about costs in general terms made them more anxious,” Dr Meropol said. “It was not surprising to us that these concerns actually affect distress, add to decisional conflict, and interfere with decision-making.”
“This finding highlighted for us that communication about costs is both necessary and challenging. It indicates that we need to be sensitive to patients’ cost concerns as they navigate decisions about cancer care.”
The researchers are now planning to develop tools to assist patients with financial navigation. The team is also developing a web-based educational program for oncology nurses to help them discuss clinical trial participation with patients.
Photo courtesy of NCI
and Matthews Media Group
A new study suggests that educating cancer patients about clinical trials—with either a general or patient-specific program—increases the likelihood that patients will enroll in such trials.
After completing either type of educational program, 21% of the cancer patients studied chose to enroll in clinical trials.
Traditionally, less than 5% of cancer patients decide to participate in trials, according to the American Cancer Society.
“Unfortunately, although clinical trials are critical for advancing cancer treatment and ultimately serve as the basis for new standards of care, very few patients participate,” said Neal J. Meropol, MD, of Case Western Reserve University School of Medicine in Cleveland, Ohio.
“We want to close the patient knowledge gap and positively affect their attitudes toward clinical trials.”
Dr Meropol and his colleagues described their effort to do just that in the Journal of Clinical Oncology.
The researchers compared a tailored video education program on clinical trials, PRE-ACT (Preparatory Education about Clinical Trials), to educational information delivered as written text.
PRE-ACT is an intervention in which patients access a website to take an online survey. The survey gauges the individual patient’s knowledge and attitudes about clinical trials, and then, based on that patient’s answers, video clips are presented addressing his or her specific concerns.
For example, patients may worry they will receive a placebo rather than active treatment, so one video clip explains how placebos are used ethically in cancer studies, and the fact that very few studies will include a placebo without any active treatment. The videos also help patients clarify their preferences in terms of quality of life or length of life.
Results
Dr Meropol and his colleagues enrolled 1255 cancer patients in the study. Half of them participated in the PRE-ACT program, and the other half received written information about clinical trials that was not specifically chosen based on their survey responses.
Both interventions improved patients’ knowledge and attitudes regarding clinical trials when compared with baseline (all P<0.001).
Patients in both arms said they felt more prepared to consider enrolling in a clinical trial after completing their assigned educational program (P<0.001), but there was a trend favoring the PRE-ACT arm (P<0.09).
Patients in the PRE-ACT arm also showed a significantly greater increase in knowledge (P<0.001) and a significantly greater decrease in attitudinal barriers (P<0.001) than patients in the text-only arm. And PRE-ACT was associated with greater patient satisfaction.
Financial concerns
During the course of this research, Dr Meropol and his colleagues made a surprising discovery. Video clips meant to address concerns about the costs of clinical trial treatment actually caused a spike in worries about the out-of-pocket costs of clinical trials.
These financial concerns generated yet another paper that appeared in the same edition of the Journal of Clinical Oncology.
“What was a surprise is that giving people information about costs in general terms made them more anxious,” Dr Meropol said. “It was not surprising to us that these concerns actually affect distress, add to decisional conflict, and interfere with decision-making.”
“This finding highlighted for us that communication about costs is both necessary and challenging. It indicates that we need to be sensitive to patients’ cost concerns as they navigate decisions about cancer care.”
The researchers are now planning to develop tools to assist patients with financial navigation. The team is also developing a web-based educational program for oncology nurses to help them discuss clinical trial participation with patients.
Photo courtesy of NCI
and Matthews Media Group
A new study suggests that educating cancer patients about clinical trials—with either a general or patient-specific program—increases the likelihood that patients will enroll in such trials.
After completing either type of educational program, 21% of the cancer patients studied chose to enroll in clinical trials.
Traditionally, less than 5% of cancer patients decide to participate in trials, according to the American Cancer Society.
“Unfortunately, although clinical trials are critical for advancing cancer treatment and ultimately serve as the basis for new standards of care, very few patients participate,” said Neal J. Meropol, MD, of Case Western Reserve University School of Medicine in Cleveland, Ohio.
“We want to close the patient knowledge gap and positively affect their attitudes toward clinical trials.”
Dr Meropol and his colleagues described their effort to do just that in the Journal of Clinical Oncology.
The researchers compared a tailored video education program on clinical trials, PRE-ACT (Preparatory Education about Clinical Trials), to educational information delivered as written text.
PRE-ACT is an intervention in which patients access a website to take an online survey. The survey gauges the individual patient’s knowledge and attitudes about clinical trials, and then, based on that patient’s answers, video clips are presented addressing his or her specific concerns.
For example, patients may worry they will receive a placebo rather than active treatment, so one video clip explains how placebos are used ethically in cancer studies, and the fact that very few studies will include a placebo without any active treatment. The videos also help patients clarify their preferences in terms of quality of life or length of life.
Results
Dr Meropol and his colleagues enrolled 1255 cancer patients in the study. Half of them participated in the PRE-ACT program, and the other half received written information about clinical trials that was not specifically chosen based on their survey responses.
Both interventions improved patients’ knowledge and attitudes regarding clinical trials when compared with baseline (all P<0.001).
Patients in both arms said they felt more prepared to consider enrolling in a clinical trial after completing their assigned educational program (P<0.001), but there was a trend favoring the PRE-ACT arm (P<0.09).
Patients in the PRE-ACT arm also showed a significantly greater increase in knowledge (P<0.001) and a significantly greater decrease in attitudinal barriers (P<0.001) than patients in the text-only arm. And PRE-ACT was associated with greater patient satisfaction.
Financial concerns
During the course of this research, Dr Meropol and his colleagues made a surprising discovery. Video clips meant to address concerns about the costs of clinical trial treatment actually caused a spike in worries about the out-of-pocket costs of clinical trials.
These financial concerns generated yet another paper that appeared in the same edition of the Journal of Clinical Oncology.
“What was a surprise is that giving people information about costs in general terms made them more anxious,” Dr Meropol said. “It was not surprising to us that these concerns actually affect distress, add to decisional conflict, and interfere with decision-making.”
“This finding highlighted for us that communication about costs is both necessary and challenging. It indicates that we need to be sensitive to patients’ cost concerns as they navigate decisions about cancer care.”
The researchers are now planning to develop tools to assist patients with financial navigation. The team is also developing a web-based educational program for oncology nurses to help them discuss clinical trial participation with patients.
Protocol could improve massive blood transfusion
An “early and aggressive” approach to massive blood transfusion can save lives in military combat zones and may provide the same benefit in civilian trauma care as well, according to an article published in the AANA Journal.
The article describes 2 patients who required massive transfusions due to multiple gunshot wounds sustained while in combat zones.
One patient received an inadequate amount of blood products and ultimately died.
But the other patient benefitted from a protocol change to ensure an adequate amount of blood products was delivered quickly.
David Gaskin, CRNA, of Huntsville Memorial Hospital in Texas, and his colleagues described these cases in the journal.
The authors noted that, while providing care in a combat zone, the transfusion of packed red blood cells (PRBC) and fresh frozen plasma (FFP) is performed in a 1:1 ratio. However, the packaging and thawing techniques of the plasma can delay the delivery of blood products and prevent a patient from receiving enough blood.
Another issue in a military environment is the challenge of effectively communicating with live donors on site, which can cause delays in obtaining fresh blood supplies. Both of these issues can have life-threatening consequences for patients.
This is what happened with the first patient described in the article. The 38-year-old man sustained multiple gunshot wounds to the left side of the chest, left side of the back, and flank.
The surgical team was unable to maintain a high ratio of PRBCs to plasma and to infuse an adequate quantity of fresh whole blood (FWB) into this patient. He received 26 units of PRBCs, 5 units of FFP, 3 units of FWB, and 1 unit of cryoprecipitate.
The patient experienced trauma-induced coagulopathy, acidosis, and hypothermia. He died within 2 hours of presentation.
Because of this death, the team identified and implemented a protocol to keep 4 FFP units thawed and ready for immediate use at all times. They also identified and prescreened additional blood donors and implemented a phone roster and base-wide overhead system to enable rapid notification of these donors.
The second patient described in the article benefitted from these changes. This 23-year-old male sustained a gunshot wound to the left lower aspect of the abdomen and multiple gunshot wounds to bilateral lower extremities.
The “early and aggressive” use of FWB and plasma provided the necessary endogenous clotting factors and platelets to promote hemostasis in this patient. He received 18 units of PRBCs, 18 units of FFP, 2 units of cryoprecipitate, and 24 units of FWB.
Gaskin and his colleagues said these results suggest that efforts to incorporate a similar resuscitation strategy into civilian practice may improve outcomes, but it warrants continued study.
An “early and aggressive” approach to massive blood transfusion can save lives in military combat zones and may provide the same benefit in civilian trauma care as well, according to an article published in the AANA Journal.
The article describes 2 patients who required massive transfusions due to multiple gunshot wounds sustained while in combat zones.
One patient received an inadequate amount of blood products and ultimately died.
But the other patient benefitted from a protocol change to ensure an adequate amount of blood products was delivered quickly.
David Gaskin, CRNA, of Huntsville Memorial Hospital in Texas, and his colleagues described these cases in the journal.
The authors noted that, while providing care in a combat zone, the transfusion of packed red blood cells (PRBC) and fresh frozen plasma (FFP) is performed in a 1:1 ratio. However, the packaging and thawing techniques of the plasma can delay the delivery of blood products and prevent a patient from receiving enough blood.
Another issue in a military environment is the challenge of effectively communicating with live donors on site, which can cause delays in obtaining fresh blood supplies. Both of these issues can have life-threatening consequences for patients.
This is what happened with the first patient described in the article. The 38-year-old man sustained multiple gunshot wounds to the left side of the chest, left side of the back, and flank.
The surgical team was unable to maintain a high ratio of PRBCs to plasma and to infuse an adequate quantity of fresh whole blood (FWB) into this patient. He received 26 units of PRBCs, 5 units of FFP, 3 units of FWB, and 1 unit of cryoprecipitate.
The patient experienced trauma-induced coagulopathy, acidosis, and hypothermia. He died within 2 hours of presentation.
Because of this death, the team identified and implemented a protocol to keep 4 FFP units thawed and ready for immediate use at all times. They also identified and prescreened additional blood donors and implemented a phone roster and base-wide overhead system to enable rapid notification of these donors.
The second patient described in the article benefitted from these changes. This 23-year-old male sustained a gunshot wound to the left lower aspect of the abdomen and multiple gunshot wounds to bilateral lower extremities.
The “early and aggressive” use of FWB and plasma provided the necessary endogenous clotting factors and platelets to promote hemostasis in this patient. He received 18 units of PRBCs, 18 units of FFP, 2 units of cryoprecipitate, and 24 units of FWB.
Gaskin and his colleagues said these results suggest that efforts to incorporate a similar resuscitation strategy into civilian practice may improve outcomes, but it warrants continued study.
An “early and aggressive” approach to massive blood transfusion can save lives in military combat zones and may provide the same benefit in civilian trauma care as well, according to an article published in the AANA Journal.
The article describes 2 patients who required massive transfusions due to multiple gunshot wounds sustained while in combat zones.
One patient received an inadequate amount of blood products and ultimately died.
But the other patient benefitted from a protocol change to ensure an adequate amount of blood products was delivered quickly.
David Gaskin, CRNA, of Huntsville Memorial Hospital in Texas, and his colleagues described these cases in the journal.
The authors noted that, while providing care in a combat zone, the transfusion of packed red blood cells (PRBC) and fresh frozen plasma (FFP) is performed in a 1:1 ratio. However, the packaging and thawing techniques of the plasma can delay the delivery of blood products and prevent a patient from receiving enough blood.
Another issue in a military environment is the challenge of effectively communicating with live donors on site, which can cause delays in obtaining fresh blood supplies. Both of these issues can have life-threatening consequences for patients.
This is what happened with the first patient described in the article. The 38-year-old man sustained multiple gunshot wounds to the left side of the chest, left side of the back, and flank.
The surgical team was unable to maintain a high ratio of PRBCs to plasma and to infuse an adequate quantity of fresh whole blood (FWB) into this patient. He received 26 units of PRBCs, 5 units of FFP, 3 units of FWB, and 1 unit of cryoprecipitate.
The patient experienced trauma-induced coagulopathy, acidosis, and hypothermia. He died within 2 hours of presentation.
Because of this death, the team identified and implemented a protocol to keep 4 FFP units thawed and ready for immediate use at all times. They also identified and prescreened additional blood donors and implemented a phone roster and base-wide overhead system to enable rapid notification of these donors.
The second patient described in the article benefitted from these changes. This 23-year-old male sustained a gunshot wound to the left lower aspect of the abdomen and multiple gunshot wounds to bilateral lower extremities.
The “early and aggressive” use of FWB and plasma provided the necessary endogenous clotting factors and platelets to promote hemostasis in this patient. He received 18 units of PRBCs, 18 units of FFP, 2 units of cryoprecipitate, and 24 units of FWB.
Gaskin and his colleagues said these results suggest that efforts to incorporate a similar resuscitation strategy into civilian practice may improve outcomes, but it warrants continued study.
Smartphone use may put patient data at risk
Photo by Daniel Sone
A new survey suggests that doctors and nurses in London are routinely using their own smartphones for patient care.
Investigators say the current lack of data encryption on these devices could result in the inadvertent disclosure of “highly sensitive and confidential data” in the absence of an active organizational strategy on digital security.
The team raised this issue and reported results of the survey in BMJ Innovations.
Mohammad H. Mobasheri, MBBS, of Imperial College London in the UK, and his colleagues wanted to determine how healthcare professionals are using digital technology on the frontline.
So the investigators invited more than 6000 clinical staff at 5 London hospitals of varying sizes to complete a questionnaire on ownership and use of portable devices and mobile health apps in the workplace.
The results are based on the responses of 287 doctors and 564 nurses from different specialties.
About 99% of doctors said they owned a smartphone, and 73.5% owned a tablet. The equivalent figures for nurses were 95.1% and 64.7%, respectively.
When asked about the usefulness of smartphones for carrying out clinical duties, 92.6% of doctors and 53.2% of nurses said these devices were “very useful” or “useful.”
Most doctors (93.8%) used their smartphone while at work to communicate with their colleagues, compared with 28.5% of nurses. About half of the doctors (50.2%) used their smartphone instead of a traditional bleep (page).
About 78% of doctors and 34.8% of nurses said they had downloaded a medical app to their device, with 89.6% of doctors and 67.1% of nurses saying they used these apps as part of their clinical work.
Of those who owned a medical app and used it at work, 41.3% of doctors reported using such an app weekly, and 33% said they used one daily. The equivalent figures for nurses were 42% and 22.3%, respectively.
The apps included drug formularies, medical calculators, and those for disease diagnosis and treatment, reference and education, documentation and drug preparation.
When asked if they had ever sent patient data over their smartphones using SMS, app-based messaging (such as WhatsApp), and picture messaging using their smartphone camera, many respondents said they had done so.
About 65% of doctors had used SMS, 33.1% had used app-based messaging, and 46% had used their phone’s camera and picture messaging to send a photo of a wound or X-ray to a colleague. The corresponding figures for nurses were much lower—13.8%, 5.7%, and 7.4%, respectively.
About 28% of doctors and 3.6% of nurses said they still retained clinical information on their smartphones.
A substantial proportion of respondents said they wanted to be able to use their own devices at work. About 72% of doctors and 37.2% of nurses wanted a secure means of sending patient data to colleagues using their own smartphone.
Fully secure messaging services for smartphones are not yet available in the UK, and the data are unlikely to be encrypted, according to investigators. They therefore urged National Health Service organizations to make sure their staff understands the potential risks of sharing patient information via their unsecured smartphones.
The team said the results of this survey provide strong evidence that healthcare organizations need to develop policies to support the safe and secure use of digital technologies in the workplace.
Photo by Daniel Sone
A new survey suggests that doctors and nurses in London are routinely using their own smartphones for patient care.
Investigators say the current lack of data encryption on these devices could result in the inadvertent disclosure of “highly sensitive and confidential data” in the absence of an active organizational strategy on digital security.
The team raised this issue and reported results of the survey in BMJ Innovations.
Mohammad H. Mobasheri, MBBS, of Imperial College London in the UK, and his colleagues wanted to determine how healthcare professionals are using digital technology on the frontline.
So the investigators invited more than 6000 clinical staff at 5 London hospitals of varying sizes to complete a questionnaire on ownership and use of portable devices and mobile health apps in the workplace.
The results are based on the responses of 287 doctors and 564 nurses from different specialties.
About 99% of doctors said they owned a smartphone, and 73.5% owned a tablet. The equivalent figures for nurses were 95.1% and 64.7%, respectively.
When asked about the usefulness of smartphones for carrying out clinical duties, 92.6% of doctors and 53.2% of nurses said these devices were “very useful” or “useful.”
Most doctors (93.8%) used their smartphone while at work to communicate with their colleagues, compared with 28.5% of nurses. About half of the doctors (50.2%) used their smartphone instead of a traditional bleep (page).
About 78% of doctors and 34.8% of nurses said they had downloaded a medical app to their device, with 89.6% of doctors and 67.1% of nurses saying they used these apps as part of their clinical work.
Of those who owned a medical app and used it at work, 41.3% of doctors reported using such an app weekly, and 33% said they used one daily. The equivalent figures for nurses were 42% and 22.3%, respectively.
The apps included drug formularies, medical calculators, and those for disease diagnosis and treatment, reference and education, documentation and drug preparation.
When asked if they had ever sent patient data over their smartphones using SMS, app-based messaging (such as WhatsApp), and picture messaging using their smartphone camera, many respondents said they had done so.
About 65% of doctors had used SMS, 33.1% had used app-based messaging, and 46% had used their phone’s camera and picture messaging to send a photo of a wound or X-ray to a colleague. The corresponding figures for nurses were much lower—13.8%, 5.7%, and 7.4%, respectively.
About 28% of doctors and 3.6% of nurses said they still retained clinical information on their smartphones.
A substantial proportion of respondents said they wanted to be able to use their own devices at work. About 72% of doctors and 37.2% of nurses wanted a secure means of sending patient data to colleagues using their own smartphone.
Fully secure messaging services for smartphones are not yet available in the UK, and the data are unlikely to be encrypted, according to investigators. They therefore urged National Health Service organizations to make sure their staff understands the potential risks of sharing patient information via their unsecured smartphones.
The team said the results of this survey provide strong evidence that healthcare organizations need to develop policies to support the safe and secure use of digital technologies in the workplace.
Photo by Daniel Sone
A new survey suggests that doctors and nurses in London are routinely using their own smartphones for patient care.
Investigators say the current lack of data encryption on these devices could result in the inadvertent disclosure of “highly sensitive and confidential data” in the absence of an active organizational strategy on digital security.
The team raised this issue and reported results of the survey in BMJ Innovations.
Mohammad H. Mobasheri, MBBS, of Imperial College London in the UK, and his colleagues wanted to determine how healthcare professionals are using digital technology on the frontline.
So the investigators invited more than 6000 clinical staff at 5 London hospitals of varying sizes to complete a questionnaire on ownership and use of portable devices and mobile health apps in the workplace.
The results are based on the responses of 287 doctors and 564 nurses from different specialties.
About 99% of doctors said they owned a smartphone, and 73.5% owned a tablet. The equivalent figures for nurses were 95.1% and 64.7%, respectively.
When asked about the usefulness of smartphones for carrying out clinical duties, 92.6% of doctors and 53.2% of nurses said these devices were “very useful” or “useful.”
Most doctors (93.8%) used their smartphone while at work to communicate with their colleagues, compared with 28.5% of nurses. About half of the doctors (50.2%) used their smartphone instead of a traditional bleep (page).
About 78% of doctors and 34.8% of nurses said they had downloaded a medical app to their device, with 89.6% of doctors and 67.1% of nurses saying they used these apps as part of their clinical work.
Of those who owned a medical app and used it at work, 41.3% of doctors reported using such an app weekly, and 33% said they used one daily. The equivalent figures for nurses were 42% and 22.3%, respectively.
The apps included drug formularies, medical calculators, and those for disease diagnosis and treatment, reference and education, documentation and drug preparation.
When asked if they had ever sent patient data over their smartphones using SMS, app-based messaging (such as WhatsApp), and picture messaging using their smartphone camera, many respondents said they had done so.
About 65% of doctors had used SMS, 33.1% had used app-based messaging, and 46% had used their phone’s camera and picture messaging to send a photo of a wound or X-ray to a colleague. The corresponding figures for nurses were much lower—13.8%, 5.7%, and 7.4%, respectively.
About 28% of doctors and 3.6% of nurses said they still retained clinical information on their smartphones.
A substantial proportion of respondents said they wanted to be able to use their own devices at work. About 72% of doctors and 37.2% of nurses wanted a secure means of sending patient data to colleagues using their own smartphone.
Fully secure messaging services for smartphones are not yet available in the UK, and the data are unlikely to be encrypted, according to investigators. They therefore urged National Health Service organizations to make sure their staff understands the potential risks of sharing patient information via their unsecured smartphones.
The team said the results of this survey provide strong evidence that healthcare organizations need to develop policies to support the safe and secure use of digital technologies in the workplace.
Group creates guide for PICC use
A group of international experts has created a guide to promote the appropriate use of peripherally inserted central catheters (PICCs) in adults.
The guide, called Michigan Appropriateness Guide for Intravenous Catheters (MAGIC), was published in Annals of Internal Medicine.
MAGIC is based on a review of evidence and was designed to give clinicians an easy-to-use framework to pick the right venous access device for each patient.
“PICCs, or peripherally inserted central catheters, have become especially convenient to place, and their use has gone up dramatically, as have the complications from them,” said guideline author Vineet Chopra, MD, of the University of Michigan in Ann Arbor.
“The easiest way to prevent these complications is not to place a PICC in the first place. So we set out to determine when the use of a PICC is appropriate and when other choices are the best.”
The experts reviewed 665 scenarios in which PICCs were used. Their use was deemed appropriate in 38% (n=253) of cases and inappropriate in 43% (n=288). In 19% (n=124) of cases, the experts could not agree or were unsure about whether PICC use was appropriate.
The experts said that, in patients with cancer, PICCs are appropriate for irritant or vesicant infusion, regardless of the duration of use.
On the other hand, they said PICC use is inappropriate for peripherally compatible infusions when the proposed duration of use is 5 days or fewer. And when the duration is between 6 days and 14 days, midline and ultrasonography-guided peripheral intravenous catheters should be used over PICCs.
The experts also said that nontunneled central venous catheters should be used over PICCs in critically ill patients when the duration of use is likely to be 14 days or fewer.
How MAGIC happened
The panel of 15 experts included doctors and nurses from a range of fields where PICCs and other such devices are commonly used, such as vascular nursing, critical care, infectious disease, and oncology. Also participating was a patient who had suffered complications from various intravenous devices and still lives with the consequences.
The panel evaluated the scenarios and supporting medical literature, and made its recommendations, using the RAND/UCLA Appropriateness Method.
The panel did not consider pediatric use of PICCs and other vascular access devices, but they hope their work could provide a framework for a similar effort in pediatrics.
Putting MAGIC to the test
MAGIC is getting its first test in 47 Michigan hospitals taking part in a patient safety project known as the Michigan Hospital Medicine Safety Consortium.
Researchers also plan to test ways to deploy MAGIC across the Veterans Affairs health system, working with the VA National Center for Patient Safety and the No Preventable Harms Campaign.
Even as they evaluate MAGIC’s ability to improve appropriate use of different devices and reduce complications, the team behind the new guide hopes other clinicians will begin using it.
“IV devices of all kinds are being put into patients without much thought about risks, benefits, or alternatives,” Dr Chopra said. “At the end of the day, we hope MAGIC will give providers the information they need to make a good decision for their patient, one that will render these devices appropriate and safe.”
Dr Chopra and his colleagues have also launched a website, improvepicc.com, that provides links to research on PICCs and other resources for clinicians.
A group of international experts has created a guide to promote the appropriate use of peripherally inserted central catheters (PICCs) in adults.
The guide, called Michigan Appropriateness Guide for Intravenous Catheters (MAGIC), was published in Annals of Internal Medicine.
MAGIC is based on a review of evidence and was designed to give clinicians an easy-to-use framework to pick the right venous access device for each patient.
“PICCs, or peripherally inserted central catheters, have become especially convenient to place, and their use has gone up dramatically, as have the complications from them,” said guideline author Vineet Chopra, MD, of the University of Michigan in Ann Arbor.
“The easiest way to prevent these complications is not to place a PICC in the first place. So we set out to determine when the use of a PICC is appropriate and when other choices are the best.”
The experts reviewed 665 scenarios in which PICCs were used. Their use was deemed appropriate in 38% (n=253) of cases and inappropriate in 43% (n=288). In 19% (n=124) of cases, the experts could not agree or were unsure about whether PICC use was appropriate.
The experts said that, in patients with cancer, PICCs are appropriate for irritant or vesicant infusion, regardless of the duration of use.
On the other hand, they said PICC use is inappropriate for peripherally compatible infusions when the proposed duration of use is 5 days or fewer. And when the duration is between 6 days and 14 days, midline and ultrasonography-guided peripheral intravenous catheters should be used over PICCs.
The experts also said that nontunneled central venous catheters should be used over PICCs in critically ill patients when the duration of use is likely to be 14 days or fewer.
How MAGIC happened
The panel of 15 experts included doctors and nurses from a range of fields where PICCs and other such devices are commonly used, such as vascular nursing, critical care, infectious disease, and oncology. Also participating was a patient who had suffered complications from various intravenous devices and still lives with the consequences.
The panel evaluated the scenarios and supporting medical literature, and made its recommendations, using the RAND/UCLA Appropriateness Method.
The panel did not consider pediatric use of PICCs and other vascular access devices, but they hope their work could provide a framework for a similar effort in pediatrics.
Putting MAGIC to the test
MAGIC is getting its first test in 47 Michigan hospitals taking part in a patient safety project known as the Michigan Hospital Medicine Safety Consortium.
Researchers also plan to test ways to deploy MAGIC across the Veterans Affairs health system, working with the VA National Center for Patient Safety and the No Preventable Harms Campaign.
Even as they evaluate MAGIC’s ability to improve appropriate use of different devices and reduce complications, the team behind the new guide hopes other clinicians will begin using it.
“IV devices of all kinds are being put into patients without much thought about risks, benefits, or alternatives,” Dr Chopra said. “At the end of the day, we hope MAGIC will give providers the information they need to make a good decision for their patient, one that will render these devices appropriate and safe.”
Dr Chopra and his colleagues have also launched a website, improvepicc.com, that provides links to research on PICCs and other resources for clinicians.
A group of international experts has created a guide to promote the appropriate use of peripherally inserted central catheters (PICCs) in adults.
The guide, called Michigan Appropriateness Guide for Intravenous Catheters (MAGIC), was published in Annals of Internal Medicine.
MAGIC is based on a review of evidence and was designed to give clinicians an easy-to-use framework to pick the right venous access device for each patient.
“PICCs, or peripherally inserted central catheters, have become especially convenient to place, and their use has gone up dramatically, as have the complications from them,” said guideline author Vineet Chopra, MD, of the University of Michigan in Ann Arbor.
“The easiest way to prevent these complications is not to place a PICC in the first place. So we set out to determine when the use of a PICC is appropriate and when other choices are the best.”
The experts reviewed 665 scenarios in which PICCs were used. Their use was deemed appropriate in 38% (n=253) of cases and inappropriate in 43% (n=288). In 19% (n=124) of cases, the experts could not agree or were unsure about whether PICC use was appropriate.
The experts said that, in patients with cancer, PICCs are appropriate for irritant or vesicant infusion, regardless of the duration of use.
On the other hand, they said PICC use is inappropriate for peripherally compatible infusions when the proposed duration of use is 5 days or fewer. And when the duration is between 6 days and 14 days, midline and ultrasonography-guided peripheral intravenous catheters should be used over PICCs.
The experts also said that nontunneled central venous catheters should be used over PICCs in critically ill patients when the duration of use is likely to be 14 days or fewer.
How MAGIC happened
The panel of 15 experts included doctors and nurses from a range of fields where PICCs and other such devices are commonly used, such as vascular nursing, critical care, infectious disease, and oncology. Also participating was a patient who had suffered complications from various intravenous devices and still lives with the consequences.
The panel evaluated the scenarios and supporting medical literature, and made its recommendations, using the RAND/UCLA Appropriateness Method.
The panel did not consider pediatric use of PICCs and other vascular access devices, but they hope their work could provide a framework for a similar effort in pediatrics.
Putting MAGIC to the test
MAGIC is getting its first test in 47 Michigan hospitals taking part in a patient safety project known as the Michigan Hospital Medicine Safety Consortium.
Researchers also plan to test ways to deploy MAGIC across the Veterans Affairs health system, working with the VA National Center for Patient Safety and the No Preventable Harms Campaign.
Even as they evaluate MAGIC’s ability to improve appropriate use of different devices and reduce complications, the team behind the new guide hopes other clinicians will begin using it.
“IV devices of all kinds are being put into patients without much thought about risks, benefits, or alternatives,” Dr Chopra said. “At the end of the day, we hope MAGIC will give providers the information they need to make a good decision for their patient, one that will render these devices appropriate and safe.”
Dr Chopra and his colleagues have also launched a website, improvepicc.com, that provides links to research on PICCs and other resources for clinicians.
Drug gets orphan designation for CDI
The US Food and Drug Administration (FDA) has granted orphan designation to SER-109 for the prevention of recurrent Clostridium difficile infection (CDI) in adults.
SER-109 is a microbiome therapeutic designed to treat recurrent CDI by correcting dysbiosis of the human microbiome.
In a single dose of 4 capsules, SER-109 re-introduces an ecology of purified bacterial spores that should restore the microbiome to a healthy state, allowing it to carry out key biological functions, including resisting Clostridium difficile.
“SER-109 is intended to re-introduce essential bacteria that restore the body’s natural resistance to CDI by re-establishing the ecology of the colonic microbiome,” explained Roger Pomerantz, MD, of Seres Therapeutics, Inc., the company developing SER-109.
“Because we’re focused on treating the underlying cause of the disease, we believe we have the potential to break the cycle of recurrent CDI and have a significant impact for patients.”
SER-109 is currently being investigated in a phase 2 trial. In addition to orphan designation, SER-109 has breakthrough designation from the FDA.
Trials of SER-109
Researchers reported phase 1/2 results with SER-109 at the 2014 Interscience Conference on Antimicrobial Agents and Chemotherapy.
The study had 2 cohorts containing 15 patients each. Patients were between 18 and 90 years old, had 3 or more laboratory-confirmed CDI episodes over 1 year, had a life expectancy greater than 3 months, and were able to give informed consent.
Patients in cohort 1 received a mean SER-109 dose of 1.5 x 109 spores, and those in cohort 2 received a mean dose of 1 x 108 spores. SER-109 was deemed effective if patients did not have a CDI recurrence in the 8-week period after they received SER-109.
In cohort 1, 87% of patients (13/15) achieved the efficacy endpoint. Two patients had transient, self-limited diarrhea with a positive C difficile test, but both reached the week 8 endpoint without needing antibiotic therapy for CDI. Thus, in cohort 1, the clinical cure rate was 100%.
In cohort 2, 93% of patients (14/15) reached the 8-week endpoint CDI-free. One patient failed per protocol.
The researchers said there were no drug-related serious adverse events in this trial.
Seres Therapeutics is currently conducting a multicenter, randomized, placebo-controlled, phase 2 study (ECOSPOR) to assess the efficacy and safety of SER-109 in preventing recurrent CDI. The company expects results from this study to be available mid-2016.
About orphan and breakthrough designation
The FDA grants orphan designation to drugs that are intended to treat diseases or conditions affecting fewer than 200,000 patients in the US.
Orphan designation provides the sponsor of a drug with various development incentives, including opportunities to apply for research-related tax credits and grant funding, assistance in designing clinical trials, and 7 years of US marketing exclusivity if the drug is approved.
The FDA’s breakthrough therapy designation is intended to expedite the development and review of a drug candidate intended to treat a serious or life-threatening condition.
The benefits of breakthrough designation include the same benefits as fast track designation—priority review of a new drug application, rolling review, etc.—plus an organizational commitment involving the FDA’s senior managers with more intensive guidance from the FDA.
The US Food and Drug Administration (FDA) has granted orphan designation to SER-109 for the prevention of recurrent Clostridium difficile infection (CDI) in adults.
SER-109 is a microbiome therapeutic designed to treat recurrent CDI by correcting dysbiosis of the human microbiome.
In a single dose of 4 capsules, SER-109 re-introduces an ecology of purified bacterial spores that should restore the microbiome to a healthy state, allowing it to carry out key biological functions, including resisting Clostridium difficile.
“SER-109 is intended to re-introduce essential bacteria that restore the body’s natural resistance to CDI by re-establishing the ecology of the colonic microbiome,” explained Roger Pomerantz, MD, of Seres Therapeutics, Inc., the company developing SER-109.
“Because we’re focused on treating the underlying cause of the disease, we believe we have the potential to break the cycle of recurrent CDI and have a significant impact for patients.”
SER-109 is currently being investigated in a phase 2 trial. In addition to orphan designation, SER-109 has breakthrough designation from the FDA.
Trials of SER-109
Researchers reported phase 1/2 results with SER-109 at the 2014 Interscience Conference on Antimicrobial Agents and Chemotherapy.
The study had 2 cohorts containing 15 patients each. Patients were between 18 and 90 years old, had 3 or more laboratory-confirmed CDI episodes over 1 year, had a life expectancy greater than 3 months, and were able to give informed consent.
Patients in cohort 1 received a mean SER-109 dose of 1.5 x 109 spores, and those in cohort 2 received a mean dose of 1 x 108 spores. SER-109 was deemed effective if patients did not have a CDI recurrence in the 8-week period after they received SER-109.
In cohort 1, 87% of patients (13/15) achieved the efficacy endpoint. Two patients had transient, self-limited diarrhea with a positive C difficile test, but both reached the week 8 endpoint without needing antibiotic therapy for CDI. Thus, in cohort 1, the clinical cure rate was 100%.
In cohort 2, 93% of patients (14/15) reached the 8-week endpoint CDI-free. One patient failed per protocol.
The researchers said there were no drug-related serious adverse events in this trial.
Seres Therapeutics is currently conducting a multicenter, randomized, placebo-controlled, phase 2 study (ECOSPOR) to assess the efficacy and safety of SER-109 in preventing recurrent CDI. The company expects results from this study to be available mid-2016.
About orphan and breakthrough designation
The FDA grants orphan designation to drugs that are intended to treat diseases or conditions affecting fewer than 200,000 patients in the US.
Orphan designation provides the sponsor of a drug with various development incentives, including opportunities to apply for research-related tax credits and grant funding, assistance in designing clinical trials, and 7 years of US marketing exclusivity if the drug is approved.
The FDA’s breakthrough therapy designation is intended to expedite the development and review of a drug candidate intended to treat a serious or life-threatening condition.
The benefits of breakthrough designation include the same benefits as fast track designation—priority review of a new drug application, rolling review, etc.—plus an organizational commitment involving the FDA’s senior managers with more intensive guidance from the FDA.
The US Food and Drug Administration (FDA) has granted orphan designation to SER-109 for the prevention of recurrent Clostridium difficile infection (CDI) in adults.
SER-109 is a microbiome therapeutic designed to treat recurrent CDI by correcting dysbiosis of the human microbiome.
In a single dose of 4 capsules, SER-109 re-introduces an ecology of purified bacterial spores that should restore the microbiome to a healthy state, allowing it to carry out key biological functions, including resisting Clostridium difficile.
“SER-109 is intended to re-introduce essential bacteria that restore the body’s natural resistance to CDI by re-establishing the ecology of the colonic microbiome,” explained Roger Pomerantz, MD, of Seres Therapeutics, Inc., the company developing SER-109.
“Because we’re focused on treating the underlying cause of the disease, we believe we have the potential to break the cycle of recurrent CDI and have a significant impact for patients.”
SER-109 is currently being investigated in a phase 2 trial. In addition to orphan designation, SER-109 has breakthrough designation from the FDA.
Trials of SER-109
Researchers reported phase 1/2 results with SER-109 at the 2014 Interscience Conference on Antimicrobial Agents and Chemotherapy.
The study had 2 cohorts containing 15 patients each. Patients were between 18 and 90 years old, had 3 or more laboratory-confirmed CDI episodes over 1 year, had a life expectancy greater than 3 months, and were able to give informed consent.
Patients in cohort 1 received a mean SER-109 dose of 1.5 x 109 spores, and those in cohort 2 received a mean dose of 1 x 108 spores. SER-109 was deemed effective if patients did not have a CDI recurrence in the 8-week period after they received SER-109.
In cohort 1, 87% of patients (13/15) achieved the efficacy endpoint. Two patients had transient, self-limited diarrhea with a positive C difficile test, but both reached the week 8 endpoint without needing antibiotic therapy for CDI. Thus, in cohort 1, the clinical cure rate was 100%.
In cohort 2, 93% of patients (14/15) reached the 8-week endpoint CDI-free. One patient failed per protocol.
The researchers said there were no drug-related serious adverse events in this trial.
Seres Therapeutics is currently conducting a multicenter, randomized, placebo-controlled, phase 2 study (ECOSPOR) to assess the efficacy and safety of SER-109 in preventing recurrent CDI. The company expects results from this study to be available mid-2016.
About orphan and breakthrough designation
The FDA grants orphan designation to drugs that are intended to treat diseases or conditions affecting fewer than 200,000 patients in the US.
Orphan designation provides the sponsor of a drug with various development incentives, including opportunities to apply for research-related tax credits and grant funding, assistance in designing clinical trials, and 7 years of US marketing exclusivity if the drug is approved.
The FDA’s breakthrough therapy designation is intended to expedite the development and review of a drug candidate intended to treat a serious or life-threatening condition.
The benefits of breakthrough designation include the same benefits as fast track designation—priority review of a new drug application, rolling review, etc.—plus an organizational commitment involving the FDA’s senior managers with more intensive guidance from the FDA.
Survey reveals inconsistency in infection prevention practices
in the intensive care unit
Results of an anonymous survey suggest healthcare professionals in the US may not consistently follow recommendations for preventing bloodstream infections in patients with arterial catheters.
Of the roughly 1000 critical care clinicians surveyed, fewer than half said they comply with the current Centers for Disease Control and Prevention (CDC) guidelines, which recommend the use of limited barrier precautions during arterial catheter insertion.
This includes sterile gloves, a surgical cap, a surgical mask, and a small sterile drape.
“Barrier precautions are employed inconsistently by critical care clinicians across the nation, and such individuals underestimate the infection risks posed by arterial catheters,” said Leonard A. Mermel, DO, of Rhode Island Hospital in Providence.
He and his colleagues reported these findings in Critical Care Medicine.
The researchers sent an anonymous, web-based survey to 11,361 physicians, nurse practitioners, physician assistants, respiratory therapists, and registered nurses who receive emails from the Society of Critical Care Medicine.
There were 1265 responses (an 11% response rate) and 1029 eligible participants after exclusions.
Of the eligible respondents, 44% said they used CDC-recommended barrier precautions during arterial catheter insertion, and 15% said they use full barrier precautions.
However, 39% of respondents said they would support mandatory use of full barrier precautions during arterial catheter insertion.
“There appears to be a significant deviation from clinical guidelines regarding a very commonly performed procedure in critically ill patients,” said study author Andrew Levinson, MD, also of Rhode Island Hospital.
“Bloodstream infections are largely preventable, and if the survey results mirror the clinical practice in the US, there’s work to be done in reducing risk of such infections.”
The survey also indicated that respondents underestimate the risk of bloodstream infections associated with arterial catheters. The respondents’ mean estimate of infection incidence was 0.3 per 1000 catheter-days, and the median estimate was 0.1 per 1000 catheter-days.
However, Dr Mermel and his colleagues said recent studies have suggested the incidence of bloodstream infections associated with arterial catheters in the US is 0.9 to 3.4 per 1000 catheter-days.
in the intensive care unit
Results of an anonymous survey suggest healthcare professionals in the US may not consistently follow recommendations for preventing bloodstream infections in patients with arterial catheters.
Of the roughly 1000 critical care clinicians surveyed, fewer than half said they comply with the current Centers for Disease Control and Prevention (CDC) guidelines, which recommend the use of limited barrier precautions during arterial catheter insertion.
This includes sterile gloves, a surgical cap, a surgical mask, and a small sterile drape.
“Barrier precautions are employed inconsistently by critical care clinicians across the nation, and such individuals underestimate the infection risks posed by arterial catheters,” said Leonard A. Mermel, DO, of Rhode Island Hospital in Providence.
He and his colleagues reported these findings in Critical Care Medicine.
The researchers sent an anonymous, web-based survey to 11,361 physicians, nurse practitioners, physician assistants, respiratory therapists, and registered nurses who receive emails from the Society of Critical Care Medicine.
There were 1265 responses (an 11% response rate) and 1029 eligible participants after exclusions.
Of the eligible respondents, 44% said they used CDC-recommended barrier precautions during arterial catheter insertion, and 15% said they use full barrier precautions.
However, 39% of respondents said they would support mandatory use of full barrier precautions during arterial catheter insertion.
“There appears to be a significant deviation from clinical guidelines regarding a very commonly performed procedure in critically ill patients,” said study author Andrew Levinson, MD, also of Rhode Island Hospital.
“Bloodstream infections are largely preventable, and if the survey results mirror the clinical practice in the US, there’s work to be done in reducing risk of such infections.”
The survey also indicated that respondents underestimate the risk of bloodstream infections associated with arterial catheters. The respondents’ mean estimate of infection incidence was 0.3 per 1000 catheter-days, and the median estimate was 0.1 per 1000 catheter-days.
However, Dr Mermel and his colleagues said recent studies have suggested the incidence of bloodstream infections associated with arterial catheters in the US is 0.9 to 3.4 per 1000 catheter-days.
in the intensive care unit
Results of an anonymous survey suggest healthcare professionals in the US may not consistently follow recommendations for preventing bloodstream infections in patients with arterial catheters.
Of the roughly 1000 critical care clinicians surveyed, fewer than half said they comply with the current Centers for Disease Control and Prevention (CDC) guidelines, which recommend the use of limited barrier precautions during arterial catheter insertion.
This includes sterile gloves, a surgical cap, a surgical mask, and a small sterile drape.
“Barrier precautions are employed inconsistently by critical care clinicians across the nation, and such individuals underestimate the infection risks posed by arterial catheters,” said Leonard A. Mermel, DO, of Rhode Island Hospital in Providence.
He and his colleagues reported these findings in Critical Care Medicine.
The researchers sent an anonymous, web-based survey to 11,361 physicians, nurse practitioners, physician assistants, respiratory therapists, and registered nurses who receive emails from the Society of Critical Care Medicine.
There were 1265 responses (an 11% response rate) and 1029 eligible participants after exclusions.
Of the eligible respondents, 44% said they used CDC-recommended barrier precautions during arterial catheter insertion, and 15% said they use full barrier precautions.
However, 39% of respondents said they would support mandatory use of full barrier precautions during arterial catheter insertion.
“There appears to be a significant deviation from clinical guidelines regarding a very commonly performed procedure in critically ill patients,” said study author Andrew Levinson, MD, also of Rhode Island Hospital.
“Bloodstream infections are largely preventable, and if the survey results mirror the clinical practice in the US, there’s work to be done in reducing risk of such infections.”
The survey also indicated that respondents underestimate the risk of bloodstream infections associated with arterial catheters. The respondents’ mean estimate of infection incidence was 0.3 per 1000 catheter-days, and the median estimate was 0.1 per 1000 catheter-days.
However, Dr Mermel and his colleagues said recent studies have suggested the incidence of bloodstream infections associated with arterial catheters in the US is 0.9 to 3.4 per 1000 catheter-days.
Adopting may be more difficult for cancer survivors
by Vera Kratochvil
Cancer survivors may face more challenges when trying to adopt a child than individuals without a history of cancer, according to a new study.
Investigators found the sizable upfront costs associated with adoption and requirements regarding a prospective parent’s health could work against cancer survivors trying to adopt.
However, the study also suggested that birth mothers might be receptive to cancer survivors as adoptive parents.
The research was published in Cancer.
Little is known about the rate at which cancer survivors successfully adopt a child or about their experiences during the adoption process. So Gwendolyn Quinn, PhD, of the Moffitt Cancer Center in Tampa, Florida, and her colleagues conducted a study to gain some insight.
The investigators asked oncology nurses who were participating in a training program to conduct interviews with adoption agencies. Seventy-seven nurses across 15 states provided summaries of their interviews.
The nurses reported that adoption fees ranged from $3000 to $75,000. They noted that the upfront costs of adoption could deter cancer survivors who already have “a huge financial burden” due to treatment costs.
Not all of the adoption agencies contacted kept records on whether prospective adoptive parents were cancer survivors. But agencies that did track this reported an average of 10 former cancer patients a year seeking adoption.
A few agencies reported that a cancer history in an adoptive parent could be discouraging for a birth mother. But most reported the opposite—that birth mothers might feel confident in choosing a parent who has overcome hardships and has an appreciation for life.
Agencies usually required prospective parents to provide a letter from a physician regarding their health and medical history. In some cases, agencies required cancer survivors to be disease-free for 5 years before they could adopt a child.
In addition, international adoptions had greater restrictions for prospective parents with a cancer history (compared to US adoptions).
Dr Quinn said these are potentially discriminatory practices akin to restricting employment opportunities for people with disabilities.
“[P]erhaps this data will bring to light the need for policy revisions in adoption processes . . . ,” she added.
by Vera Kratochvil
Cancer survivors may face more challenges when trying to adopt a child than individuals without a history of cancer, according to a new study.
Investigators found the sizable upfront costs associated with adoption and requirements regarding a prospective parent’s health could work against cancer survivors trying to adopt.
However, the study also suggested that birth mothers might be receptive to cancer survivors as adoptive parents.
The research was published in Cancer.
Little is known about the rate at which cancer survivors successfully adopt a child or about their experiences during the adoption process. So Gwendolyn Quinn, PhD, of the Moffitt Cancer Center in Tampa, Florida, and her colleagues conducted a study to gain some insight.
The investigators asked oncology nurses who were participating in a training program to conduct interviews with adoption agencies. Seventy-seven nurses across 15 states provided summaries of their interviews.
The nurses reported that adoption fees ranged from $3000 to $75,000. They noted that the upfront costs of adoption could deter cancer survivors who already have “a huge financial burden” due to treatment costs.
Not all of the adoption agencies contacted kept records on whether prospective adoptive parents were cancer survivors. But agencies that did track this reported an average of 10 former cancer patients a year seeking adoption.
A few agencies reported that a cancer history in an adoptive parent could be discouraging for a birth mother. But most reported the opposite—that birth mothers might feel confident in choosing a parent who has overcome hardships and has an appreciation for life.
Agencies usually required prospective parents to provide a letter from a physician regarding their health and medical history. In some cases, agencies required cancer survivors to be disease-free for 5 years before they could adopt a child.
In addition, international adoptions had greater restrictions for prospective parents with a cancer history (compared to US adoptions).
Dr Quinn said these are potentially discriminatory practices akin to restricting employment opportunities for people with disabilities.
“[P]erhaps this data will bring to light the need for policy revisions in adoption processes . . . ,” she added.
by Vera Kratochvil
Cancer survivors may face more challenges when trying to adopt a child than individuals without a history of cancer, according to a new study.
Investigators found the sizable upfront costs associated with adoption and requirements regarding a prospective parent’s health could work against cancer survivors trying to adopt.
However, the study also suggested that birth mothers might be receptive to cancer survivors as adoptive parents.
The research was published in Cancer.
Little is known about the rate at which cancer survivors successfully adopt a child or about their experiences during the adoption process. So Gwendolyn Quinn, PhD, of the Moffitt Cancer Center in Tampa, Florida, and her colleagues conducted a study to gain some insight.
The investigators asked oncology nurses who were participating in a training program to conduct interviews with adoption agencies. Seventy-seven nurses across 15 states provided summaries of their interviews.
The nurses reported that adoption fees ranged from $3000 to $75,000. They noted that the upfront costs of adoption could deter cancer survivors who already have “a huge financial burden” due to treatment costs.
Not all of the adoption agencies contacted kept records on whether prospective adoptive parents were cancer survivors. But agencies that did track this reported an average of 10 former cancer patients a year seeking adoption.
A few agencies reported that a cancer history in an adoptive parent could be discouraging for a birth mother. But most reported the opposite—that birth mothers might feel confident in choosing a parent who has overcome hardships and has an appreciation for life.
Agencies usually required prospective parents to provide a letter from a physician regarding their health and medical history. In some cases, agencies required cancer survivors to be disease-free for 5 years before they could adopt a child.
In addition, international adoptions had greater restrictions for prospective parents with a cancer history (compared to US adoptions).
Dr Quinn said these are potentially discriminatory practices akin to restricting employment opportunities for people with disabilities.
“[P]erhaps this data will bring to light the need for policy revisions in adoption processes . . . ,” she added.
Healthcare professionals work while sick despite risk to patients
Photo by Logan Tuttle
Results of a small survey showed that many healthcare professionals reported to work while sick, despite recognizing that this could put their patients at risk.
About 95% of survey respondents acknowledged that working while sick puts patients at risk, but 83% of respondents said they had worked while sick at least once in the past year.
About 9% of respondents reported working while sick at least 5 times.
Julia E. Szymczak, PhD, of the Children’s Hospital of Philadelphia in Pennsylvania, and her colleagues reported these results in JAMA Pediatrics alongside a related editorial.
The researchers administered an anonymous survey to attending physicians and advanced practice clinicians (APCs) at the Children’s Hospital of Philadelphia. APCs included certified registered nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.
Overall, 280 attending physicians (61%) and 256 APCs (54.5%) responded. Most respondents (504, 95.3%) said working while sick put patients at risk.
However, 446 respondents (83.1%) reported working while sick at least once in the past year, and 50 respondents (9.3%) reported working while sick at least 5 times.
Respondents reported working with symptoms that included diarrhea, fever, and the onset of significant respiratory symptoms.
The reasons physicians and APCs worked while sick included not wanting to let colleagues down (98.7%), staffing concerns (94.9%), not wanting to let patients down (92.5%), fear of being ostracized by colleagues (64%), and concerns about the continuity of care (63.8%).
An analysis of written comments about why respondents work while sick highlighted 3 areas: challenges in identifying and arranging someone to cover their work and a lack of resources to accommodate sick leave, a strong cultural norm in the hospital to report for work unless one is extremely ill, and ambiguity about what symptoms constitute being too sick to work.
Dr Szymczak and her colleagues said this study suggests complex social and logistical factors cause healthcare workers to report to work sick. But these results could inform efforts to help workers make the right choice to keep their patients and colleagues safe while caring for themselves.
Photo by Logan Tuttle
Results of a small survey showed that many healthcare professionals reported to work while sick, despite recognizing that this could put their patients at risk.
About 95% of survey respondents acknowledged that working while sick puts patients at risk, but 83% of respondents said they had worked while sick at least once in the past year.
About 9% of respondents reported working while sick at least 5 times.
Julia E. Szymczak, PhD, of the Children’s Hospital of Philadelphia in Pennsylvania, and her colleagues reported these results in JAMA Pediatrics alongside a related editorial.
The researchers administered an anonymous survey to attending physicians and advanced practice clinicians (APCs) at the Children’s Hospital of Philadelphia. APCs included certified registered nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.
Overall, 280 attending physicians (61%) and 256 APCs (54.5%) responded. Most respondents (504, 95.3%) said working while sick put patients at risk.
However, 446 respondents (83.1%) reported working while sick at least once in the past year, and 50 respondents (9.3%) reported working while sick at least 5 times.
Respondents reported working with symptoms that included diarrhea, fever, and the onset of significant respiratory symptoms.
The reasons physicians and APCs worked while sick included not wanting to let colleagues down (98.7%), staffing concerns (94.9%), not wanting to let patients down (92.5%), fear of being ostracized by colleagues (64%), and concerns about the continuity of care (63.8%).
An analysis of written comments about why respondents work while sick highlighted 3 areas: challenges in identifying and arranging someone to cover their work and a lack of resources to accommodate sick leave, a strong cultural norm in the hospital to report for work unless one is extremely ill, and ambiguity about what symptoms constitute being too sick to work.
Dr Szymczak and her colleagues said this study suggests complex social and logistical factors cause healthcare workers to report to work sick. But these results could inform efforts to help workers make the right choice to keep their patients and colleagues safe while caring for themselves.
Photo by Logan Tuttle
Results of a small survey showed that many healthcare professionals reported to work while sick, despite recognizing that this could put their patients at risk.
About 95% of survey respondents acknowledged that working while sick puts patients at risk, but 83% of respondents said they had worked while sick at least once in the past year.
About 9% of respondents reported working while sick at least 5 times.
Julia E. Szymczak, PhD, of the Children’s Hospital of Philadelphia in Pennsylvania, and her colleagues reported these results in JAMA Pediatrics alongside a related editorial.
The researchers administered an anonymous survey to attending physicians and advanced practice clinicians (APCs) at the Children’s Hospital of Philadelphia. APCs included certified registered nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.
Overall, 280 attending physicians (61%) and 256 APCs (54.5%) responded. Most respondents (504, 95.3%) said working while sick put patients at risk.
However, 446 respondents (83.1%) reported working while sick at least once in the past year, and 50 respondents (9.3%) reported working while sick at least 5 times.
Respondents reported working with symptoms that included diarrhea, fever, and the onset of significant respiratory symptoms.
The reasons physicians and APCs worked while sick included not wanting to let colleagues down (98.7%), staffing concerns (94.9%), not wanting to let patients down (92.5%), fear of being ostracized by colleagues (64%), and concerns about the continuity of care (63.8%).
An analysis of written comments about why respondents work while sick highlighted 3 areas: challenges in identifying and arranging someone to cover their work and a lack of resources to accommodate sick leave, a strong cultural norm in the hospital to report for work unless one is extremely ill, and ambiguity about what symptoms constitute being too sick to work.
Dr Szymczak and her colleagues said this study suggests complex social and logistical factors cause healthcare workers to report to work sick. But these results could inform efforts to help workers make the right choice to keep their patients and colleagues safe while caring for themselves.