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Infection may cause implant-associated ALCL

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Infection may cause implant-associated ALCL

Breast implant

Credit: FDA

Bacterial infection on the surface of textured breast implants may increase the risk of developing breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), according to research published in Plastic & Reconstructive Surgery.

Previous studies have shown that biofilm infection around breast implants is a major cause of capsular contracture, a painful hardening of the tissue around the implant that can cause physical deformity and pain.

Now, researchers have found that chronic infection around implants can also lead to an activation of the immune system and the patient’s lymphocytes. And long-term stimulation of lymphocytes by this infection may prompt the transformation of these cells into BIA-ALCL.

The infection was shown to be highest around textured breast implants, and this may provide an explanation as to why BIA-ALCL seems to be more common in patients with textured implants.

“Our previous research has shown that, 24 hours after bacteria come into contact with breast implants, textured implants had 72 times the number of bacteria attached to their surface as compared with the smooth implants,” said Anand Deva, MBBS, of Macquarie University in Sydney, Australia.

“This latest study has shown that the textured implants with the highest numbers of bacteria also had the highest number of activated lymphocytes around them. This finding is important and has now become even more relevant since the reporting of BIA-ALCL, as it provides us with a possible biological explanation of how this rare cancer could arise.”

To uncover these findings, Dr Devan and his colleagues first examined implants in pigs. The team inserted 12 textured and 12 smooth implants into submammary pockets in 3 adult pigs.

After a mean of 8.75 months, all of the samples were positive for bacterial biofilm. And there was a significant correlation between bacterial numbers and the grade of capsular contracture (P=0.04).

Lymphocyte numbers were significantly higher on textured implants (P<0.001), with T cells accounting for the majority of the lymphocytic infiltrate.

The researchers then examined implants in humans, collecting 57 capsules from patients with Baker grade 4 capsules over a 4-year period. The team analyzed biofilm and the surrounding lymphocytes.

As in the pigs, all of the capsules were positive for biofilm, and T cells were the predominant lymphocyte (P<0.001).

The researchers also discovered a significant linear correlation between the number of T and B cells and the number of detected bacteria (P<0.001). And there was a significantly higher number of bacteria for polyurethane implants (P<0.005).

These results suggest a possible link between bacterial biofilm and T-cell hyperplasia, a finding that may have implications for BIA-ALCL, the researchers said.

Dr Deva and his colleagues have published a 14-step guide to reduce the risk of breast implant infection, based on evidence of best practice to educate surgeons on how to reduce the risk of bacterial contamination.

A number of clinical studies have applied these principles and successfully reduced the rate of capsular contracture by a factor of 10 in their patients.

“This is a great validation of our research and a demonstration that good science in the laboratory can be translated into real benefits to patients at the bedside,” Dr Deva said.

“Now, with our greater understanding of the importance of preventing infection, we, as surgeons, can reduce the risk of capsular contracture and thereby reduce the risk of lymphocyte activation and possible transformation into BIA-ALCL.”

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Breast implant

Credit: FDA

Bacterial infection on the surface of textured breast implants may increase the risk of developing breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), according to research published in Plastic & Reconstructive Surgery.

Previous studies have shown that biofilm infection around breast implants is a major cause of capsular contracture, a painful hardening of the tissue around the implant that can cause physical deformity and pain.

Now, researchers have found that chronic infection around implants can also lead to an activation of the immune system and the patient’s lymphocytes. And long-term stimulation of lymphocytes by this infection may prompt the transformation of these cells into BIA-ALCL.

The infection was shown to be highest around textured breast implants, and this may provide an explanation as to why BIA-ALCL seems to be more common in patients with textured implants.

“Our previous research has shown that, 24 hours after bacteria come into contact with breast implants, textured implants had 72 times the number of bacteria attached to their surface as compared with the smooth implants,” said Anand Deva, MBBS, of Macquarie University in Sydney, Australia.

“This latest study has shown that the textured implants with the highest numbers of bacteria also had the highest number of activated lymphocytes around them. This finding is important and has now become even more relevant since the reporting of BIA-ALCL, as it provides us with a possible biological explanation of how this rare cancer could arise.”

To uncover these findings, Dr Devan and his colleagues first examined implants in pigs. The team inserted 12 textured and 12 smooth implants into submammary pockets in 3 adult pigs.

After a mean of 8.75 months, all of the samples were positive for bacterial biofilm. And there was a significant correlation between bacterial numbers and the grade of capsular contracture (P=0.04).

Lymphocyte numbers were significantly higher on textured implants (P<0.001), with T cells accounting for the majority of the lymphocytic infiltrate.

The researchers then examined implants in humans, collecting 57 capsules from patients with Baker grade 4 capsules over a 4-year period. The team analyzed biofilm and the surrounding lymphocytes.

As in the pigs, all of the capsules were positive for biofilm, and T cells were the predominant lymphocyte (P<0.001).

The researchers also discovered a significant linear correlation between the number of T and B cells and the number of detected bacteria (P<0.001). And there was a significantly higher number of bacteria for polyurethane implants (P<0.005).

These results suggest a possible link between bacterial biofilm and T-cell hyperplasia, a finding that may have implications for BIA-ALCL, the researchers said.

Dr Deva and his colleagues have published a 14-step guide to reduce the risk of breast implant infection, based on evidence of best practice to educate surgeons on how to reduce the risk of bacterial contamination.

A number of clinical studies have applied these principles and successfully reduced the rate of capsular contracture by a factor of 10 in their patients.

“This is a great validation of our research and a demonstration that good science in the laboratory can be translated into real benefits to patients at the bedside,” Dr Deva said.

“Now, with our greater understanding of the importance of preventing infection, we, as surgeons, can reduce the risk of capsular contracture and thereby reduce the risk of lymphocyte activation and possible transformation into BIA-ALCL.”

Breast implant

Credit: FDA

Bacterial infection on the surface of textured breast implants may increase the risk of developing breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), according to research published in Plastic & Reconstructive Surgery.

Previous studies have shown that biofilm infection around breast implants is a major cause of capsular contracture, a painful hardening of the tissue around the implant that can cause physical deformity and pain.

Now, researchers have found that chronic infection around implants can also lead to an activation of the immune system and the patient’s lymphocytes. And long-term stimulation of lymphocytes by this infection may prompt the transformation of these cells into BIA-ALCL.

The infection was shown to be highest around textured breast implants, and this may provide an explanation as to why BIA-ALCL seems to be more common in patients with textured implants.

“Our previous research has shown that, 24 hours after bacteria come into contact with breast implants, textured implants had 72 times the number of bacteria attached to their surface as compared with the smooth implants,” said Anand Deva, MBBS, of Macquarie University in Sydney, Australia.

“This latest study has shown that the textured implants with the highest numbers of bacteria also had the highest number of activated lymphocytes around them. This finding is important and has now become even more relevant since the reporting of BIA-ALCL, as it provides us with a possible biological explanation of how this rare cancer could arise.”

To uncover these findings, Dr Devan and his colleagues first examined implants in pigs. The team inserted 12 textured and 12 smooth implants into submammary pockets in 3 adult pigs.

After a mean of 8.75 months, all of the samples were positive for bacterial biofilm. And there was a significant correlation between bacterial numbers and the grade of capsular contracture (P=0.04).

Lymphocyte numbers were significantly higher on textured implants (P<0.001), with T cells accounting for the majority of the lymphocytic infiltrate.

The researchers then examined implants in humans, collecting 57 capsules from patients with Baker grade 4 capsules over a 4-year period. The team analyzed biofilm and the surrounding lymphocytes.

As in the pigs, all of the capsules were positive for biofilm, and T cells were the predominant lymphocyte (P<0.001).

The researchers also discovered a significant linear correlation between the number of T and B cells and the number of detected bacteria (P<0.001). And there was a significantly higher number of bacteria for polyurethane implants (P<0.005).

These results suggest a possible link between bacterial biofilm and T-cell hyperplasia, a finding that may have implications for BIA-ALCL, the researchers said.

Dr Deva and his colleagues have published a 14-step guide to reduce the risk of breast implant infection, based on evidence of best practice to educate surgeons on how to reduce the risk of bacterial contamination.

A number of clinical studies have applied these principles and successfully reduced the rate of capsular contracture by a factor of 10 in their patients.

“This is a great validation of our research and a demonstration that good science in the laboratory can be translated into real benefits to patients at the bedside,” Dr Deva said.

“Now, with our greater understanding of the importance of preventing infection, we, as surgeons, can reduce the risk of capsular contracture and thereby reduce the risk of lymphocyte activation and possible transformation into BIA-ALCL.”

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Product approved for hemophilia A in Canada, Australia

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Antihemophilic factor

Health Canada and Australia’s Therapeutic Goods Administration (TGA) have both approved a recombinant FVIII product known as simoctocog alfa (Nuwiq).

Health Canada has approved the product to treat and prevent bleeding in hemophilia A patients of all ages.

And the TGA has approved simoctocog alfa for the treatment and prevention of bleeding in previously treated pediatric (≥ 2 years) and adult patients with

hemophilia A.

Simoctocog alfa is a recombinant FVIII product produced in a human cell line cultured without additives of human or animal origin or any exposure to human blood or plasma, making it inherently free from blood-borne pathogens.

Simoctocog alfa is also devoid of antigenic non-human protein epitopes, similar to FVIII produced in healthy humans. It has a high affinity for the von Willebrand coagulation factor.

“The way Nuwiq is produced is exciting, as it allows the molecule to closely resemble the naturally occurring FVIII,” said Anthony Chan, MBBS, Director of the Hemophilia Program at McMaster Children’s Hospital in Hamilton, Ontario.

“Health Canada’s approval of Nuwiq provides patients with hemophilia A a new recombinant product option that will allow further customization of hemophilia treatment on an individual basis.”

Researchers have evaluated the immunogenicity of simoctocog alfa in 135 previously treated patients with hemophilia A (74 adults and 61 children). And none of the patients developed inhibitors.

In the ongoing, phase 3 NuProtect study, researchers are investigating 100 previously untreated patients, a group typically characterized by a higher risk of inhibitor development. The researchers will assess whether the molecular properties of simoctocog alfa will result in lower inhibitor development.

Two additional phase 3 studies in previously treated patients are ongoing. The NuPreviq study and the Canadian Gena-21b study were designed to assess the efficacy and safety of individually tailored prophylaxis.

The goal of these studies is to provide optimal treatment for each patient based on his or her own pharmacokinetic properties, with a potential reduction in the frequency of FVIII infusions.

Simoctocog alfa was approved in the European Union earlier this year and is under review by regulatory authorities in the US. For more details on simoctocog alfa, see the prescribing information.

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Antihemophilic factor

Health Canada and Australia’s Therapeutic Goods Administration (TGA) have both approved a recombinant FVIII product known as simoctocog alfa (Nuwiq).

Health Canada has approved the product to treat and prevent bleeding in hemophilia A patients of all ages.

And the TGA has approved simoctocog alfa for the treatment and prevention of bleeding in previously treated pediatric (≥ 2 years) and adult patients with

hemophilia A.

Simoctocog alfa is a recombinant FVIII product produced in a human cell line cultured without additives of human or animal origin or any exposure to human blood or plasma, making it inherently free from blood-borne pathogens.

Simoctocog alfa is also devoid of antigenic non-human protein epitopes, similar to FVIII produced in healthy humans. It has a high affinity for the von Willebrand coagulation factor.

“The way Nuwiq is produced is exciting, as it allows the molecule to closely resemble the naturally occurring FVIII,” said Anthony Chan, MBBS, Director of the Hemophilia Program at McMaster Children’s Hospital in Hamilton, Ontario.

“Health Canada’s approval of Nuwiq provides patients with hemophilia A a new recombinant product option that will allow further customization of hemophilia treatment on an individual basis.”

Researchers have evaluated the immunogenicity of simoctocog alfa in 135 previously treated patients with hemophilia A (74 adults and 61 children). And none of the patients developed inhibitors.

In the ongoing, phase 3 NuProtect study, researchers are investigating 100 previously untreated patients, a group typically characterized by a higher risk of inhibitor development. The researchers will assess whether the molecular properties of simoctocog alfa will result in lower inhibitor development.

Two additional phase 3 studies in previously treated patients are ongoing. The NuPreviq study and the Canadian Gena-21b study were designed to assess the efficacy and safety of individually tailored prophylaxis.

The goal of these studies is to provide optimal treatment for each patient based on his or her own pharmacokinetic properties, with a potential reduction in the frequency of FVIII infusions.

Simoctocog alfa was approved in the European Union earlier this year and is under review by regulatory authorities in the US. For more details on simoctocog alfa, see the prescribing information.

Antihemophilic factor

Health Canada and Australia’s Therapeutic Goods Administration (TGA) have both approved a recombinant FVIII product known as simoctocog alfa (Nuwiq).

Health Canada has approved the product to treat and prevent bleeding in hemophilia A patients of all ages.

And the TGA has approved simoctocog alfa for the treatment and prevention of bleeding in previously treated pediatric (≥ 2 years) and adult patients with

hemophilia A.

Simoctocog alfa is a recombinant FVIII product produced in a human cell line cultured without additives of human or animal origin or any exposure to human blood or plasma, making it inherently free from blood-borne pathogens.

Simoctocog alfa is also devoid of antigenic non-human protein epitopes, similar to FVIII produced in healthy humans. It has a high affinity for the von Willebrand coagulation factor.

“The way Nuwiq is produced is exciting, as it allows the molecule to closely resemble the naturally occurring FVIII,” said Anthony Chan, MBBS, Director of the Hemophilia Program at McMaster Children’s Hospital in Hamilton, Ontario.

“Health Canada’s approval of Nuwiq provides patients with hemophilia A a new recombinant product option that will allow further customization of hemophilia treatment on an individual basis.”

Researchers have evaluated the immunogenicity of simoctocog alfa in 135 previously treated patients with hemophilia A (74 adults and 61 children). And none of the patients developed inhibitors.

In the ongoing, phase 3 NuProtect study, researchers are investigating 100 previously untreated patients, a group typically characterized by a higher risk of inhibitor development. The researchers will assess whether the molecular properties of simoctocog alfa will result in lower inhibitor development.

Two additional phase 3 studies in previously treated patients are ongoing. The NuPreviq study and the Canadian Gena-21b study were designed to assess the efficacy and safety of individually tailored prophylaxis.

The goal of these studies is to provide optimal treatment for each patient based on his or her own pharmacokinetic properties, with a potential reduction in the frequency of FVIII infusions.

Simoctocog alfa was approved in the European Union earlier this year and is under review by regulatory authorities in the US. For more details on simoctocog alfa, see the prescribing information.

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How ‘urban’ mosquitoes transmit malaria

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Anopheles stephensi

Credit: CDC

Researchers believe that by analyzing the genome of a mosquito species, they have discovered how that mosquito evolves to withstand a variety of environmental conditions.

The results, published in Genome Biology, provide a better understanding of Anopheles stephensi, a common carrier of malaria in urban environments.

Anopheles stephensi is emerging as a model mosquito species for genetic and molecular studies,” said Zhijian Jake Tu, PhD, of Virginia Tech in Blacksburg.

He and his colleagues believe their genome map of An stephensi will be an important tool for scientists to identify potential targets for mosquito control. In addition, studies of immunity genes can provide insight into mosquito biology and mosquito-parasite interactions.

“Genome mapping of Anopheles stephensi revealed genetic differences between it and a species especially dangerous for transmitting malaria in Africa, Anopheles gambiae,” said Igor Sharakhov, PhD, also of Virginia Tech.

“This tells us that the sex chromosome is especially prone to mutations that flip chromosomal segments, which, in turn, may promote new, evolved species.”

The researchers assembled more than 92% of the An stephensi genome, and physical mapping assigned 62% of the genome onto chromosomes.

When the team compared An stephensi and An gambiae, they discovered the rate of gene order reshuffling on the Anopheles X chromosome was 3 times higher than that on the autosomes.

An stephensi had more repeat-rich heterochromatin in pericentric regions than An gambiae but fewer repetitive sequences in chromosome arms.

The researchers also identified Y-chromosome contigs and BACs, which represent the most abundant set of Y sequences in any Anopheles species.

Lastly, the team noted that RNA-sequencing and studies of immunity genes provided new insights into mosquito biology and mosquito-parasite interactions.

For instance, FKBP12, a protein that interacts with TOR and TGF-β signaling pathways, showed abundant mRNA expression in a wide range of tissues. This information could help improve our understanding of TOR and TGF-β signaling in mosquitoes.

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Anopheles stephensi

Credit: CDC

Researchers believe that by analyzing the genome of a mosquito species, they have discovered how that mosquito evolves to withstand a variety of environmental conditions.

The results, published in Genome Biology, provide a better understanding of Anopheles stephensi, a common carrier of malaria in urban environments.

Anopheles stephensi is emerging as a model mosquito species for genetic and molecular studies,” said Zhijian Jake Tu, PhD, of Virginia Tech in Blacksburg.

He and his colleagues believe their genome map of An stephensi will be an important tool for scientists to identify potential targets for mosquito control. In addition, studies of immunity genes can provide insight into mosquito biology and mosquito-parasite interactions.

“Genome mapping of Anopheles stephensi revealed genetic differences between it and a species especially dangerous for transmitting malaria in Africa, Anopheles gambiae,” said Igor Sharakhov, PhD, also of Virginia Tech.

“This tells us that the sex chromosome is especially prone to mutations that flip chromosomal segments, which, in turn, may promote new, evolved species.”

The researchers assembled more than 92% of the An stephensi genome, and physical mapping assigned 62% of the genome onto chromosomes.

When the team compared An stephensi and An gambiae, they discovered the rate of gene order reshuffling on the Anopheles X chromosome was 3 times higher than that on the autosomes.

An stephensi had more repeat-rich heterochromatin in pericentric regions than An gambiae but fewer repetitive sequences in chromosome arms.

The researchers also identified Y-chromosome contigs and BACs, which represent the most abundant set of Y sequences in any Anopheles species.

Lastly, the team noted that RNA-sequencing and studies of immunity genes provided new insights into mosquito biology and mosquito-parasite interactions.

For instance, FKBP12, a protein that interacts with TOR and TGF-β signaling pathways, showed abundant mRNA expression in a wide range of tissues. This information could help improve our understanding of TOR and TGF-β signaling in mosquitoes.

Anopheles stephensi

Credit: CDC

Researchers believe that by analyzing the genome of a mosquito species, they have discovered how that mosquito evolves to withstand a variety of environmental conditions.

The results, published in Genome Biology, provide a better understanding of Anopheles stephensi, a common carrier of malaria in urban environments.

Anopheles stephensi is emerging as a model mosquito species for genetic and molecular studies,” said Zhijian Jake Tu, PhD, of Virginia Tech in Blacksburg.

He and his colleagues believe their genome map of An stephensi will be an important tool for scientists to identify potential targets for mosquito control. In addition, studies of immunity genes can provide insight into mosquito biology and mosquito-parasite interactions.

“Genome mapping of Anopheles stephensi revealed genetic differences between it and a species especially dangerous for transmitting malaria in Africa, Anopheles gambiae,” said Igor Sharakhov, PhD, also of Virginia Tech.

“This tells us that the sex chromosome is especially prone to mutations that flip chromosomal segments, which, in turn, may promote new, evolved species.”

The researchers assembled more than 92% of the An stephensi genome, and physical mapping assigned 62% of the genome onto chromosomes.

When the team compared An stephensi and An gambiae, they discovered the rate of gene order reshuffling on the Anopheles X chromosome was 3 times higher than that on the autosomes.

An stephensi had more repeat-rich heterochromatin in pericentric regions than An gambiae but fewer repetitive sequences in chromosome arms.

The researchers also identified Y-chromosome contigs and BACs, which represent the most abundant set of Y sequences in any Anopheles species.

Lastly, the team noted that RNA-sequencing and studies of immunity genes provided new insights into mosquito biology and mosquito-parasite interactions.

For instance, FKBP12, a protein that interacts with TOR and TGF-β signaling pathways, showed abundant mRNA expression in a wide range of tissues. This information could help improve our understanding of TOR and TGF-β signaling in mosquitoes.

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TACO linked to amount and type of blood product transfused

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PHILADELPHIA—Results of a population-based study suggest that elderly adults in the US have seen an increase in the rate of transfusion-associated circulatory overload (TACO) in the last few years.

The risk of TACO increased with advancing age and with increases in the number of units transfused.

TACO rates also appeared to be related to the type of blood components transfused. Patients were more likely to develop TACO if they received red blood cells (RBCs) with plasma and/or platelets.

Mikhail Menis, PharmD, of the Center for Biologics Evaluation and Research at the US Food and Drug Administration in Rockville, Maryland, and his colleagues presented these findings in a poster (SP203) at the AABB Annual Meeting 2014.

The researchers conducted this retrospective, claims-based study to assess TACO occurrence and potential risk factors for the condition among elderly Medicare beneficiaries (aged 65 and older) who were transfused as inpatients from 2011 through 2013.

Among the 6,382,814 inpatient transfusion stays, 4405 included a record of TACO. So the overall rate of TACO was 69.0 per 100,000 stays.

TACO rates (per 100,000) increased significantly over time, from 63.0 in 2011 to 68.0 in 2012 and 77.1 in 2013 (P<0.001).

TACO rates also increased significantly with age—44.5 for patients age 65 to 69, 58.8 for patients age 70 to 74, 66.4 for patients age 75 to 79, 78.7 for patients age 80 to 84, and 91.6 for patients age 85 and older (P<0.001).

Women had a significantly higher rate of TACO than men—76.9 and 58.9, respectively (P<0.001), and whites had a significantly higher rate of TACO than non-whites—73.0 and 49.8, respectively (P<0.001).

In addition, the rate of TACO increased significantly with the number of units transfused. Rates were 30.9 for 1 unit, 63.3 for 2 to 4 units, 103.0 for 5 to 9 units, and 139.8 for more than 9 units (P<0.001).

And TACO rates differed according to the type of blood components transfused. The rate of TACO was 29.2 for patients who received only platelets, 60.8 for those received only plasma, and 73.0 for those who received only RBCs.

The rates were 37.8 for patients who received platelets and plasma; 143.5 for those who received RBCs, plasma, and platelets; 167.9 for those who received RBCs and platelets; and 191.4 for those who received RBCs and plasma.

The researchers noted that this study had its limitations, including potential under-recording or misrecording of transfusion procedures and units, as well as a lack of clinical details to validate TACO diagnoses.

In addition, the rate comparisons were not adjusted for potential confounders, but the researchers are planning to perform adjusted analyses to confirm potential risk factors for TACO in the elderly.

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PHILADELPHIA—Results of a population-based study suggest that elderly adults in the US have seen an increase in the rate of transfusion-associated circulatory overload (TACO) in the last few years.

The risk of TACO increased with advancing age and with increases in the number of units transfused.

TACO rates also appeared to be related to the type of blood components transfused. Patients were more likely to develop TACO if they received red blood cells (RBCs) with plasma and/or platelets.

Mikhail Menis, PharmD, of the Center for Biologics Evaluation and Research at the US Food and Drug Administration in Rockville, Maryland, and his colleagues presented these findings in a poster (SP203) at the AABB Annual Meeting 2014.

The researchers conducted this retrospective, claims-based study to assess TACO occurrence and potential risk factors for the condition among elderly Medicare beneficiaries (aged 65 and older) who were transfused as inpatients from 2011 through 2013.

Among the 6,382,814 inpatient transfusion stays, 4405 included a record of TACO. So the overall rate of TACO was 69.0 per 100,000 stays.

TACO rates (per 100,000) increased significantly over time, from 63.0 in 2011 to 68.0 in 2012 and 77.1 in 2013 (P<0.001).

TACO rates also increased significantly with age—44.5 for patients age 65 to 69, 58.8 for patients age 70 to 74, 66.4 for patients age 75 to 79, 78.7 for patients age 80 to 84, and 91.6 for patients age 85 and older (P<0.001).

Women had a significantly higher rate of TACO than men—76.9 and 58.9, respectively (P<0.001), and whites had a significantly higher rate of TACO than non-whites—73.0 and 49.8, respectively (P<0.001).

In addition, the rate of TACO increased significantly with the number of units transfused. Rates were 30.9 for 1 unit, 63.3 for 2 to 4 units, 103.0 for 5 to 9 units, and 139.8 for more than 9 units (P<0.001).

And TACO rates differed according to the type of blood components transfused. The rate of TACO was 29.2 for patients who received only platelets, 60.8 for those received only plasma, and 73.0 for those who received only RBCs.

The rates were 37.8 for patients who received platelets and plasma; 143.5 for those who received RBCs, plasma, and platelets; 167.9 for those who received RBCs and platelets; and 191.4 for those who received RBCs and plasma.

The researchers noted that this study had its limitations, including potential under-recording or misrecording of transfusion procedures and units, as well as a lack of clinical details to validate TACO diagnoses.

In addition, the rate comparisons were not adjusted for potential confounders, but the researchers are planning to perform adjusted analyses to confirm potential risk factors for TACO in the elderly.

PHILADELPHIA—Results of a population-based study suggest that elderly adults in the US have seen an increase in the rate of transfusion-associated circulatory overload (TACO) in the last few years.

The risk of TACO increased with advancing age and with increases in the number of units transfused.

TACO rates also appeared to be related to the type of blood components transfused. Patients were more likely to develop TACO if they received red blood cells (RBCs) with plasma and/or platelets.

Mikhail Menis, PharmD, of the Center for Biologics Evaluation and Research at the US Food and Drug Administration in Rockville, Maryland, and his colleagues presented these findings in a poster (SP203) at the AABB Annual Meeting 2014.

The researchers conducted this retrospective, claims-based study to assess TACO occurrence and potential risk factors for the condition among elderly Medicare beneficiaries (aged 65 and older) who were transfused as inpatients from 2011 through 2013.

Among the 6,382,814 inpatient transfusion stays, 4405 included a record of TACO. So the overall rate of TACO was 69.0 per 100,000 stays.

TACO rates (per 100,000) increased significantly over time, from 63.0 in 2011 to 68.0 in 2012 and 77.1 in 2013 (P<0.001).

TACO rates also increased significantly with age—44.5 for patients age 65 to 69, 58.8 for patients age 70 to 74, 66.4 for patients age 75 to 79, 78.7 for patients age 80 to 84, and 91.6 for patients age 85 and older (P<0.001).

Women had a significantly higher rate of TACO than men—76.9 and 58.9, respectively (P<0.001), and whites had a significantly higher rate of TACO than non-whites—73.0 and 49.8, respectively (P<0.001).

In addition, the rate of TACO increased significantly with the number of units transfused. Rates were 30.9 for 1 unit, 63.3 for 2 to 4 units, 103.0 for 5 to 9 units, and 139.8 for more than 9 units (P<0.001).

And TACO rates differed according to the type of blood components transfused. The rate of TACO was 29.2 for patients who received only platelets, 60.8 for those received only plasma, and 73.0 for those who received only RBCs.

The rates were 37.8 for patients who received platelets and plasma; 143.5 for those who received RBCs, plasma, and platelets; 167.9 for those who received RBCs and platelets; and 191.4 for those who received RBCs and plasma.

The researchers noted that this study had its limitations, including potential under-recording or misrecording of transfusion procedures and units, as well as a lack of clinical details to validate TACO diagnoses.

In addition, the rate comparisons were not adjusted for potential confounders, but the researchers are planning to perform adjusted analyses to confirm potential risk factors for TACO in the elderly.

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Blood sample storage may hinder leukemia research

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Blood samples

Credit: Graham Colm

Storing blood samples at room temperature can induce changes that may cloud research findings, according to a group of investigators.

The team initially found that blood samples from leukemia patients had high levels of malformed RNA, a discovery they believed could explain leukemia’s origins.

But additional research showed this abnormality was a result of storing blood samples at room temperature for hours, or even days, prior to processing.

Heidi Dvinge, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, and her colleagues reported these findings in PNAS.

The investigators had searched databases to collect genomic information on leukemia patients and healthy control subjects. In all but one of the datasets they analyzed, the team found high levels of abnormal RNA in leukemia cells.

Another finding was that samples from pediatric leukemia patients had the highest levels of abnormal RNA. And this led the researchers to speculate about the cause.

They realized that pediatric leukemias are rare, so blood samples can be difficult to obtain. Therefore, the samples in the databases were collected at facilities throughout the world and shipped to where they were needed. So the samples could be stored at room temperature for days at a time.

To confirm that this practice can affect blood samples, the investigators conducted an experiment. They collected samples from 4 healthy subjects (2 men and 2 women) and looked for differences between samples that were processed immediately and samples that sat in the lab at room temperature for up to 48 hours.

Sure enough, the team observed changes in the stored samples, even if they were only stored for 4 hours. Stored samples exhibited biased activation of biological pathways and upregulation of pseudogenes, antisense RNAs, and unannotated coding isoforms.

Storage affected a number of genes that play roles in biological pathways relevant to leukemia, including cytokine production, NF-κB signaling, chromatin modification, and RNA splicing. Additionally, storage inhibited RNA surveillance, leading to the genome-wide expression of normally degraded RNAs.

The researchers said these findings coincide with the database findings, as they observed inhibited RNA surveillance in all but one of the datasets they analyzed.

The samples from that dataset were processed immediately after collection. And samples from healthy subjects were processed immediately, which explains why those samples were normal as well.

The team also noted that they did not observe inhibited RNA surveillance in lymphoma or solid tumor datasets.

These results suggest previous research utilizing these types of databases may contain errors, and future work making use of these databases could be affected as well.

Fortunately, the investigators found that putting blood samples on ice can prevent the negative effects they observed. The group also identified biomarkers that indicate prolonged storage, so researchers can look for those biomarkers if chilling blood samples is not an option.

In addition to describing these findings in PNAS, Dr Dvinge and her colleagues are planning to present their work at the upcoming ASH Annual Meeting.

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Blood samples

Credit: Graham Colm

Storing blood samples at room temperature can induce changes that may cloud research findings, according to a group of investigators.

The team initially found that blood samples from leukemia patients had high levels of malformed RNA, a discovery they believed could explain leukemia’s origins.

But additional research showed this abnormality was a result of storing blood samples at room temperature for hours, or even days, prior to processing.

Heidi Dvinge, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, and her colleagues reported these findings in PNAS.

The investigators had searched databases to collect genomic information on leukemia patients and healthy control subjects. In all but one of the datasets they analyzed, the team found high levels of abnormal RNA in leukemia cells.

Another finding was that samples from pediatric leukemia patients had the highest levels of abnormal RNA. And this led the researchers to speculate about the cause.

They realized that pediatric leukemias are rare, so blood samples can be difficult to obtain. Therefore, the samples in the databases were collected at facilities throughout the world and shipped to where they were needed. So the samples could be stored at room temperature for days at a time.

To confirm that this practice can affect blood samples, the investigators conducted an experiment. They collected samples from 4 healthy subjects (2 men and 2 women) and looked for differences between samples that were processed immediately and samples that sat in the lab at room temperature for up to 48 hours.

Sure enough, the team observed changes in the stored samples, even if they were only stored for 4 hours. Stored samples exhibited biased activation of biological pathways and upregulation of pseudogenes, antisense RNAs, and unannotated coding isoforms.

Storage affected a number of genes that play roles in biological pathways relevant to leukemia, including cytokine production, NF-κB signaling, chromatin modification, and RNA splicing. Additionally, storage inhibited RNA surveillance, leading to the genome-wide expression of normally degraded RNAs.

The researchers said these findings coincide with the database findings, as they observed inhibited RNA surveillance in all but one of the datasets they analyzed.

The samples from that dataset were processed immediately after collection. And samples from healthy subjects were processed immediately, which explains why those samples were normal as well.

The team also noted that they did not observe inhibited RNA surveillance in lymphoma or solid tumor datasets.

These results suggest previous research utilizing these types of databases may contain errors, and future work making use of these databases could be affected as well.

Fortunately, the investigators found that putting blood samples on ice can prevent the negative effects they observed. The group also identified biomarkers that indicate prolonged storage, so researchers can look for those biomarkers if chilling blood samples is not an option.

In addition to describing these findings in PNAS, Dr Dvinge and her colleagues are planning to present their work at the upcoming ASH Annual Meeting.

Blood samples

Credit: Graham Colm

Storing blood samples at room temperature can induce changes that may cloud research findings, according to a group of investigators.

The team initially found that blood samples from leukemia patients had high levels of malformed RNA, a discovery they believed could explain leukemia’s origins.

But additional research showed this abnormality was a result of storing blood samples at room temperature for hours, or even days, prior to processing.

Heidi Dvinge, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, and her colleagues reported these findings in PNAS.

The investigators had searched databases to collect genomic information on leukemia patients and healthy control subjects. In all but one of the datasets they analyzed, the team found high levels of abnormal RNA in leukemia cells.

Another finding was that samples from pediatric leukemia patients had the highest levels of abnormal RNA. And this led the researchers to speculate about the cause.

They realized that pediatric leukemias are rare, so blood samples can be difficult to obtain. Therefore, the samples in the databases were collected at facilities throughout the world and shipped to where they were needed. So the samples could be stored at room temperature for days at a time.

To confirm that this practice can affect blood samples, the investigators conducted an experiment. They collected samples from 4 healthy subjects (2 men and 2 women) and looked for differences between samples that were processed immediately and samples that sat in the lab at room temperature for up to 48 hours.

Sure enough, the team observed changes in the stored samples, even if they were only stored for 4 hours. Stored samples exhibited biased activation of biological pathways and upregulation of pseudogenes, antisense RNAs, and unannotated coding isoforms.

Storage affected a number of genes that play roles in biological pathways relevant to leukemia, including cytokine production, NF-κB signaling, chromatin modification, and RNA splicing. Additionally, storage inhibited RNA surveillance, leading to the genome-wide expression of normally degraded RNAs.

The researchers said these findings coincide with the database findings, as they observed inhibited RNA surveillance in all but one of the datasets they analyzed.

The samples from that dataset were processed immediately after collection. And samples from healthy subjects were processed immediately, which explains why those samples were normal as well.

The team also noted that they did not observe inhibited RNA surveillance in lymphoma or solid tumor datasets.

These results suggest previous research utilizing these types of databases may contain errors, and future work making use of these databases could be affected as well.

Fortunately, the investigators found that putting blood samples on ice can prevent the negative effects they observed. The group also identified biomarkers that indicate prolonged storage, so researchers can look for those biomarkers if chilling blood samples is not an option.

In addition to describing these findings in PNAS, Dr Dvinge and her colleagues are planning to present their work at the upcoming ASH Annual Meeting.

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Sharing research with public prompts more citations

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Researchers in the lab

Credit: Rhoda Baer

Academic researchers who talk to the press and use social media are more likely than their less communicative peers to have their work cited, a new study suggests.

The research revealed a connection between h-index—a measure of the quality of a researcher’s work and influence—and whether the scientists interact with reporters and get mentioned on Twitter.

The results appear in Journalism & Mass Communications Quarterly.

“I’ve been in science communication for a while now, and I am really seeing a change—especially among the younger scientists—in their willingness to share their work,” said study author Dominique Brossard, PhD, of the University of Wisconsin-Madison.

Attention from reporters is good news for h-index, Dr Brossard noted. But couple that with attention on Twitter, and you see a more pronounced spike in reputation.

“If you talk to reporters and you tweet about your research, your work is more likely to be cited than people who do one or the other,” she said.

That sort of activity hasn’t always been encouraged, Dr Brossard pointed out. Any distraction from a researcher’s work can draw criticism as a waste of a precious resource. But Dr Brossard hopes a new understanding of the relationship between research and communicating with the public can change that.

“What this shows us is that sharing your science with the public is not hurting the science by stealing time,” she said. “If the goal is to encourage people, ultimately, to be productive scientists, and if directors of labs are discouraging people from engaging in this activity, they’re actually hurting the science itself. Because people who do this are cited more often in scientific journals, [and] they’re making science accessible to broader audiences at the same time.”

Social media use is rising in other professional circles as well, according to Michael Xenos, PhD, also of the University of Wisconsin-Madison.

“As in other areas, such as politics for example, social media was once met with skepticism but is increasingly part of the culture,” he said. “Just like it became the norm there, our research shows it may one day become the norm in science.”

Even if you flip the connection between social media attention and h-index on its head, it’s still worth taking to heart, according to the researchers.

“The counter argument is that it may be just the other way around—that it may just be the big names that get mentions,” said study author Dietram A. Scheufele, PhD, also of the University of Wisconsin-Madison.

“But then, the lesson should be that the most successful people in your field are also the ones that are good at getting outside the ivory tower. That should be something to emulate.”

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Researchers in the lab

Credit: Rhoda Baer

Academic researchers who talk to the press and use social media are more likely than their less communicative peers to have their work cited, a new study suggests.

The research revealed a connection between h-index—a measure of the quality of a researcher’s work and influence—and whether the scientists interact with reporters and get mentioned on Twitter.

The results appear in Journalism & Mass Communications Quarterly.

“I’ve been in science communication for a while now, and I am really seeing a change—especially among the younger scientists—in their willingness to share their work,” said study author Dominique Brossard, PhD, of the University of Wisconsin-Madison.

Attention from reporters is good news for h-index, Dr Brossard noted. But couple that with attention on Twitter, and you see a more pronounced spike in reputation.

“If you talk to reporters and you tweet about your research, your work is more likely to be cited than people who do one or the other,” she said.

That sort of activity hasn’t always been encouraged, Dr Brossard pointed out. Any distraction from a researcher’s work can draw criticism as a waste of a precious resource. But Dr Brossard hopes a new understanding of the relationship between research and communicating with the public can change that.

“What this shows us is that sharing your science with the public is not hurting the science by stealing time,” she said. “If the goal is to encourage people, ultimately, to be productive scientists, and if directors of labs are discouraging people from engaging in this activity, they’re actually hurting the science itself. Because people who do this are cited more often in scientific journals, [and] they’re making science accessible to broader audiences at the same time.”

Social media use is rising in other professional circles as well, according to Michael Xenos, PhD, also of the University of Wisconsin-Madison.

“As in other areas, such as politics for example, social media was once met with skepticism but is increasingly part of the culture,” he said. “Just like it became the norm there, our research shows it may one day become the norm in science.”

Even if you flip the connection between social media attention and h-index on its head, it’s still worth taking to heart, according to the researchers.

“The counter argument is that it may be just the other way around—that it may just be the big names that get mentions,” said study author Dietram A. Scheufele, PhD, also of the University of Wisconsin-Madison.

“But then, the lesson should be that the most successful people in your field are also the ones that are good at getting outside the ivory tower. That should be something to emulate.”

Researchers in the lab

Credit: Rhoda Baer

Academic researchers who talk to the press and use social media are more likely than their less communicative peers to have their work cited, a new study suggests.

The research revealed a connection between h-index—a measure of the quality of a researcher’s work and influence—and whether the scientists interact with reporters and get mentioned on Twitter.

The results appear in Journalism & Mass Communications Quarterly.

“I’ve been in science communication for a while now, and I am really seeing a change—especially among the younger scientists—in their willingness to share their work,” said study author Dominique Brossard, PhD, of the University of Wisconsin-Madison.

Attention from reporters is good news for h-index, Dr Brossard noted. But couple that with attention on Twitter, and you see a more pronounced spike in reputation.

“If you talk to reporters and you tweet about your research, your work is more likely to be cited than people who do one or the other,” she said.

That sort of activity hasn’t always been encouraged, Dr Brossard pointed out. Any distraction from a researcher’s work can draw criticism as a waste of a precious resource. But Dr Brossard hopes a new understanding of the relationship between research and communicating with the public can change that.

“What this shows us is that sharing your science with the public is not hurting the science by stealing time,” she said. “If the goal is to encourage people, ultimately, to be productive scientists, and if directors of labs are discouraging people from engaging in this activity, they’re actually hurting the science itself. Because people who do this are cited more often in scientific journals, [and] they’re making science accessible to broader audiences at the same time.”

Social media use is rising in other professional circles as well, according to Michael Xenos, PhD, also of the University of Wisconsin-Madison.

“As in other areas, such as politics for example, social media was once met with skepticism but is increasingly part of the culture,” he said. “Just like it became the norm there, our research shows it may one day become the norm in science.”

Even if you flip the connection between social media attention and h-index on its head, it’s still worth taking to heart, according to the researchers.

“The counter argument is that it may be just the other way around—that it may just be the big names that get mentions,” said study author Dietram A. Scheufele, PhD, also of the University of Wisconsin-Madison.

“But then, the lesson should be that the most successful people in your field are also the ones that are good at getting outside the ivory tower. That should be something to emulate.”

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Sharing research with public prompts more citations
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Hospice cuts cost and use of care for cancer patients

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Doctor and patient

Credit: CDC

Patients with advanced cancer receive less aggressive care and have lower healthcare costs during their last year of life if they use hospice care, according to research published in JAMA.

Patients who entered hospice had significantly lower rates of hospitalization, intensive care unit admissions, and invasive procedures, compared to patients who did not enter hospice.

Furthermore, patients who chose hospice were about 5 times less likely to die in hospitals and nursing homes.

“Our study shows very clearly that hospice matters,” said Ziad Obermeyer, MD, of Brigham and Women’s Hospital in Boston.

“Hospice and non-hospice patients had very similar patterns of healthcare utilization right up until the week of hospice enrollment. Then, the care started to look very different. Patients who didn’t enroll in hospice ended up with far more aggressive care in their last year of life, most of it related to acute complications like infections and organ failure, and not directly related to their cancer diagnosis.”

To conduct this study, Dr Obermeyer and his colleagues used data from Medicare beneficiaries with poor-prognosis cancers, including hematologic malignancies. The study included a nationally representative 20% sample of Medicare fee-for-service beneficiaries who died in 2011.

Among 86,851 patients, 51,924 (60%) entered hospice before death. Matching patients based on various criteria produced hospice and non-hospice groups, each with 18,165 patients. The median hospice duration was 11 days.

The researchers found that non-hospice patients had significantly greater healthcare utilization, largely for acute conditions not directly related to cancer.

This included rates of hospitalization (65% vs 42%), intensive care unit admissions (36% vs 15%), invasive procedures (51% vs 27%), and death in a hospital or nursing facility (74% vs 14%).

The costs of care for hospice and non-hospice patients were not significantly different before hospice care began. But they diverged sharply thereafter, contributing to a significant difference in total costs of $8697 over the last year of life—$71,517 for non-hospice patients and $62,819 for hospice patients.

“These findings highlight the importance of honest discussions between doctors and patients about our patients’ goals of their care at the end of life, relating to treatment decisions and quality of life,” Dr  Obermeyer said. “This is of particular importance now, in light of the ongoing policy discussions around reimbursing providers for advance-care planning.”

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Doctor and patient

Credit: CDC

Patients with advanced cancer receive less aggressive care and have lower healthcare costs during their last year of life if they use hospice care, according to research published in JAMA.

Patients who entered hospice had significantly lower rates of hospitalization, intensive care unit admissions, and invasive procedures, compared to patients who did not enter hospice.

Furthermore, patients who chose hospice were about 5 times less likely to die in hospitals and nursing homes.

“Our study shows very clearly that hospice matters,” said Ziad Obermeyer, MD, of Brigham and Women’s Hospital in Boston.

“Hospice and non-hospice patients had very similar patterns of healthcare utilization right up until the week of hospice enrollment. Then, the care started to look very different. Patients who didn’t enroll in hospice ended up with far more aggressive care in their last year of life, most of it related to acute complications like infections and organ failure, and not directly related to their cancer diagnosis.”

To conduct this study, Dr Obermeyer and his colleagues used data from Medicare beneficiaries with poor-prognosis cancers, including hematologic malignancies. The study included a nationally representative 20% sample of Medicare fee-for-service beneficiaries who died in 2011.

Among 86,851 patients, 51,924 (60%) entered hospice before death. Matching patients based on various criteria produced hospice and non-hospice groups, each with 18,165 patients. The median hospice duration was 11 days.

The researchers found that non-hospice patients had significantly greater healthcare utilization, largely for acute conditions not directly related to cancer.

This included rates of hospitalization (65% vs 42%), intensive care unit admissions (36% vs 15%), invasive procedures (51% vs 27%), and death in a hospital or nursing facility (74% vs 14%).

The costs of care for hospice and non-hospice patients were not significantly different before hospice care began. But they diverged sharply thereafter, contributing to a significant difference in total costs of $8697 over the last year of life—$71,517 for non-hospice patients and $62,819 for hospice patients.

“These findings highlight the importance of honest discussions between doctors and patients about our patients’ goals of their care at the end of life, relating to treatment decisions and quality of life,” Dr  Obermeyer said. “This is of particular importance now, in light of the ongoing policy discussions around reimbursing providers for advance-care planning.”

Doctor and patient

Credit: CDC

Patients with advanced cancer receive less aggressive care and have lower healthcare costs during their last year of life if they use hospice care, according to research published in JAMA.

Patients who entered hospice had significantly lower rates of hospitalization, intensive care unit admissions, and invasive procedures, compared to patients who did not enter hospice.

Furthermore, patients who chose hospice were about 5 times less likely to die in hospitals and nursing homes.

“Our study shows very clearly that hospice matters,” said Ziad Obermeyer, MD, of Brigham and Women’s Hospital in Boston.

“Hospice and non-hospice patients had very similar patterns of healthcare utilization right up until the week of hospice enrollment. Then, the care started to look very different. Patients who didn’t enroll in hospice ended up with far more aggressive care in their last year of life, most of it related to acute complications like infections and organ failure, and not directly related to their cancer diagnosis.”

To conduct this study, Dr Obermeyer and his colleagues used data from Medicare beneficiaries with poor-prognosis cancers, including hematologic malignancies. The study included a nationally representative 20% sample of Medicare fee-for-service beneficiaries who died in 2011.

Among 86,851 patients, 51,924 (60%) entered hospice before death. Matching patients based on various criteria produced hospice and non-hospice groups, each with 18,165 patients. The median hospice duration was 11 days.

The researchers found that non-hospice patients had significantly greater healthcare utilization, largely for acute conditions not directly related to cancer.

This included rates of hospitalization (65% vs 42%), intensive care unit admissions (36% vs 15%), invasive procedures (51% vs 27%), and death in a hospital or nursing facility (74% vs 14%).

The costs of care for hospice and non-hospice patients were not significantly different before hospice care began. But they diverged sharply thereafter, contributing to a significant difference in total costs of $8697 over the last year of life—$71,517 for non-hospice patients and $62,819 for hospice patients.

“These findings highlight the importance of honest discussions between doctors and patients about our patients’ goals of their care at the end of life, relating to treatment decisions and quality of life,” Dr  Obermeyer said. “This is of particular importance now, in light of the ongoing policy discussions around reimbursing providers for advance-care planning.”

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NICE supports use of catheter-positioning device

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PICC

The UK’s National Institute for Health and Care Excellence (NICE) has opened consultation on a draft guidance about a device designed to help healthcare professionals correctly place peripherally inserted central catheters

(PICCs).

The draft guidance supports using the Sherlock 3CG Tip Confirmation System for placing PICCs.

The standard procedure for placing PICCs is blind insertion, followed by a chest X-ray to check the catheter’s position.

In some cases, fluoroscopy is used instead of standard X-ray to assist with positioning the PICC when placing it proves difficult.

The Sherlock system, on the other hand, uses magnetic and electrocardiographic real-time tracking of a PICC to enable the person placing the catheter to detect and correct any error in how the tip is positioned.

The device’s manufacturer, C.R. Bard, says the Sherlock System eliminates the need for the patient to have an X-ray, thus preventing delays in treatment or monitoring.

“Using the technology also increases staff and patient confidence of the accuracy of the procedure during catheter insertion,” said Professor Carole Longson, director of the NICE centre for health technology evaluation.

The cost of the Sherlock 3CG TCS is stated in the manufacturer’s submission as £9990 (excluding value-added tax). The cost of consumables associated with each insertion is £189.91. Maintenance costs associated with the technology are £595 per year.

Across the whole population in which PICCs are placed, the cost of using the Sherlock system is similar to blind insertion followed by X-ray, but it can save up to £106 per patient in specific clinical situations.

In intensive care, where PICCs are more likely to be placed incorrectly using blind insertion, the savings from using the Sherlock system and a confirmatory X-ray are estimated at around £41 per patient, compared with blind insertion and standard X-ray. (In intensive care settings, staff members sometimes initially use Sherlock with confirmatory X-ray while they are becoming accustomed to the system.)

For more information on the system, see the draft guidance consultation. It is open for public comment until December 9. {HT_DN}

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PICC

The UK’s National Institute for Health and Care Excellence (NICE) has opened consultation on a draft guidance about a device designed to help healthcare professionals correctly place peripherally inserted central catheters

(PICCs).

The draft guidance supports using the Sherlock 3CG Tip Confirmation System for placing PICCs.

The standard procedure for placing PICCs is blind insertion, followed by a chest X-ray to check the catheter’s position.

In some cases, fluoroscopy is used instead of standard X-ray to assist with positioning the PICC when placing it proves difficult.

The Sherlock system, on the other hand, uses magnetic and electrocardiographic real-time tracking of a PICC to enable the person placing the catheter to detect and correct any error in how the tip is positioned.

The device’s manufacturer, C.R. Bard, says the Sherlock System eliminates the need for the patient to have an X-ray, thus preventing delays in treatment or monitoring.

“Using the technology also increases staff and patient confidence of the accuracy of the procedure during catheter insertion,” said Professor Carole Longson, director of the NICE centre for health technology evaluation.

The cost of the Sherlock 3CG TCS is stated in the manufacturer’s submission as £9990 (excluding value-added tax). The cost of consumables associated with each insertion is £189.91. Maintenance costs associated with the technology are £595 per year.

Across the whole population in which PICCs are placed, the cost of using the Sherlock system is similar to blind insertion followed by X-ray, but it can save up to £106 per patient in specific clinical situations.

In intensive care, where PICCs are more likely to be placed incorrectly using blind insertion, the savings from using the Sherlock system and a confirmatory X-ray are estimated at around £41 per patient, compared with blind insertion and standard X-ray. (In intensive care settings, staff members sometimes initially use Sherlock with confirmatory X-ray while they are becoming accustomed to the system.)

For more information on the system, see the draft guidance consultation. It is open for public comment until December 9. {HT_DN}

PICC

The UK’s National Institute for Health and Care Excellence (NICE) has opened consultation on a draft guidance about a device designed to help healthcare professionals correctly place peripherally inserted central catheters

(PICCs).

The draft guidance supports using the Sherlock 3CG Tip Confirmation System for placing PICCs.

The standard procedure for placing PICCs is blind insertion, followed by a chest X-ray to check the catheter’s position.

In some cases, fluoroscopy is used instead of standard X-ray to assist with positioning the PICC when placing it proves difficult.

The Sherlock system, on the other hand, uses magnetic and electrocardiographic real-time tracking of a PICC to enable the person placing the catheter to detect and correct any error in how the tip is positioned.

The device’s manufacturer, C.R. Bard, says the Sherlock System eliminates the need for the patient to have an X-ray, thus preventing delays in treatment or monitoring.

“Using the technology also increases staff and patient confidence of the accuracy of the procedure during catheter insertion,” said Professor Carole Longson, director of the NICE centre for health technology evaluation.

The cost of the Sherlock 3CG TCS is stated in the manufacturer’s submission as £9990 (excluding value-added tax). The cost of consumables associated with each insertion is £189.91. Maintenance costs associated with the technology are £595 per year.

Across the whole population in which PICCs are placed, the cost of using the Sherlock system is similar to blind insertion followed by X-ray, but it can save up to £106 per patient in specific clinical situations.

In intensive care, where PICCs are more likely to be placed incorrectly using blind insertion, the savings from using the Sherlock system and a confirmatory X-ray are estimated at around £41 per patient, compared with blind insertion and standard X-ray. (In intensive care settings, staff members sometimes initially use Sherlock with confirmatory X-ray while they are becoming accustomed to the system.)

For more information on the system, see the draft guidance consultation. It is open for public comment until December 9. {HT_DN}

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Compounds could treat CML more effectively

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Scientist at a computer

Credit: Darren Baker

A handful of newly identified compounds may be able to treat chronic myelogenous leukemia (CML) more effectively than the tyrosine kinase inhibitors (TKIs) currently on the market, new research suggests.

Investigators identified 7 molecules that exhibited the potential to be more potent than approved TKIs.

Experiments suggested that 5 of the compounds—DB07107, DB06977, ST013616, DB04200, and ST007180—were more effective at inhibiting T315I-mutant BCR-ABL than wild-type BCR-ABL.

And 2 of them—ST019342 and DB01172—were effective only against mutant BCR-ABL.

Hemanth Naick Banavath, a PhD student at Pondicherry University-India, and his colleagues detailed these results in Nature: Scientific Reports.

To identify compounds to treat CML, the investigators screened several small molecule databases and docked against wild-type and drug-resistant T315I-mutant BCR-ABL.

The team also docked the TKIs ponatinib, bosutinib, bafetinib, dasatinib, nilotinib, and imatinib.

They identified 7 lead molecules—DB07107, DB06977, ST013616, DB04200, ST007180, ST019342, and DB01172—with better binding affinity and higher binding free energy than the TKIs.

Molecular dynamics simulations showed the dynamic behavior of protein-ligand complexes.

The protein backbone and ligand backbone of DB07107, DB06977, ST013616, DB04200, ST007180, and DB01172 were stable throughout the simulation period.

But the backbone of ST019342 showed anomalous fluctuations, and DB01172 showed instability with wild-type BCR-ABL.

A hydrogen bond analysis revealed that DB01172 has 6 hydrogens on average. However, in wild-type, it has 2 to 3 hydrogens on average. The investigators said this suggests low efficacy toward wild-type BCR-ABL.

Taking these findings together, the team said they cannot recommend ST019342 and DB01172 as potential treatments for CML.

On the other hand, they can endorse DB07107, DB06977, ST013616, DB04200, and ST007180, which showed “remarkable results.”

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Scientist at a computer

Credit: Darren Baker

A handful of newly identified compounds may be able to treat chronic myelogenous leukemia (CML) more effectively than the tyrosine kinase inhibitors (TKIs) currently on the market, new research suggests.

Investigators identified 7 molecules that exhibited the potential to be more potent than approved TKIs.

Experiments suggested that 5 of the compounds—DB07107, DB06977, ST013616, DB04200, and ST007180—were more effective at inhibiting T315I-mutant BCR-ABL than wild-type BCR-ABL.

And 2 of them—ST019342 and DB01172—were effective only against mutant BCR-ABL.

Hemanth Naick Banavath, a PhD student at Pondicherry University-India, and his colleagues detailed these results in Nature: Scientific Reports.

To identify compounds to treat CML, the investigators screened several small molecule databases and docked against wild-type and drug-resistant T315I-mutant BCR-ABL.

The team also docked the TKIs ponatinib, bosutinib, bafetinib, dasatinib, nilotinib, and imatinib.

They identified 7 lead molecules—DB07107, DB06977, ST013616, DB04200, ST007180, ST019342, and DB01172—with better binding affinity and higher binding free energy than the TKIs.

Molecular dynamics simulations showed the dynamic behavior of protein-ligand complexes.

The protein backbone and ligand backbone of DB07107, DB06977, ST013616, DB04200, ST007180, and DB01172 were stable throughout the simulation period.

But the backbone of ST019342 showed anomalous fluctuations, and DB01172 showed instability with wild-type BCR-ABL.

A hydrogen bond analysis revealed that DB01172 has 6 hydrogens on average. However, in wild-type, it has 2 to 3 hydrogens on average. The investigators said this suggests low efficacy toward wild-type BCR-ABL.

Taking these findings together, the team said they cannot recommend ST019342 and DB01172 as potential treatments for CML.

On the other hand, they can endorse DB07107, DB06977, ST013616, DB04200, and ST007180, which showed “remarkable results.”

Scientist at a computer

Credit: Darren Baker

A handful of newly identified compounds may be able to treat chronic myelogenous leukemia (CML) more effectively than the tyrosine kinase inhibitors (TKIs) currently on the market, new research suggests.

Investigators identified 7 molecules that exhibited the potential to be more potent than approved TKIs.

Experiments suggested that 5 of the compounds—DB07107, DB06977, ST013616, DB04200, and ST007180—were more effective at inhibiting T315I-mutant BCR-ABL than wild-type BCR-ABL.

And 2 of them—ST019342 and DB01172—were effective only against mutant BCR-ABL.

Hemanth Naick Banavath, a PhD student at Pondicherry University-India, and his colleagues detailed these results in Nature: Scientific Reports.

To identify compounds to treat CML, the investigators screened several small molecule databases and docked against wild-type and drug-resistant T315I-mutant BCR-ABL.

The team also docked the TKIs ponatinib, bosutinib, bafetinib, dasatinib, nilotinib, and imatinib.

They identified 7 lead molecules—DB07107, DB06977, ST013616, DB04200, ST007180, ST019342, and DB01172—with better binding affinity and higher binding free energy than the TKIs.

Molecular dynamics simulations showed the dynamic behavior of protein-ligand complexes.

The protein backbone and ligand backbone of DB07107, DB06977, ST013616, DB04200, ST007180, and DB01172 were stable throughout the simulation period.

But the backbone of ST019342 showed anomalous fluctuations, and DB01172 showed instability with wild-type BCR-ABL.

A hydrogen bond analysis revealed that DB01172 has 6 hydrogens on average. However, in wild-type, it has 2 to 3 hydrogens on average. The investigators said this suggests low efficacy toward wild-type BCR-ABL.

Taking these findings together, the team said they cannot recommend ST019342 and DB01172 as potential treatments for CML.

On the other hand, they can endorse DB07107, DB06977, ST013616, DB04200, and ST007180, which showed “remarkable results.”

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Group develops cancer health literacy tool

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Doctor consults with cancer

patient and her father

Credit: Rhoda Baer

A new tool can identify patients with limited cancer health literacy, according to research published in the Journal of Health Communications.

The study authors noted that cancer patients are expected to play an active role in their care by adhering to medication regimens, distinguishing between scientifically credible medical evidence and misconceptions, and communicating with their providers about treatment decisions, risks, and survival rates.

However, patients with limited cancer health literacy can struggle with these responsibilities and potentially jeopardize their health by making uninformed decisions.

So Levent Dumenci, PhD, of Virginia Commonwealth University in Richmond, and his colleagues developed a tool to assess health literacy among cancer patients.

“Before now, there were only instruments that measured a particular aspect of general health literacy,” Dr Dumenci said. “It is important to have a tool that is specific to cancer because of the complex treatment options that cancer patients face, along with the increased demand for self-care.”

To meet that need, he and his colleagues developed the Cancer Health Literacy Test (CHLT)-30. The test, which is given via a touch-screen device, includes 30

questions about cancer treatment, medication side effects, and other cancer-related issues.

Six of the questions (CHLT-6) were specifically designed to quickly identify individuals with limited cancer health literacy.

The researchers tested the CHLT-30 in 1306 African American and Caucasian patients who were treated at oncology clinics in Virginia.

The team said the test accurately measured literacy and quickly identified patients with limited cancer health literacy. Eighteen percent of cancer patients had limited literacy, with an overrepresentation of African American, undereducated, and low-income patients.

“Using this tool, it takes just 1 to 2 minutes in the doctor’s office waiting room to identify patients with limited [cancer health literacy],” Dr Dumenci said. “Then, this information can be digitally communicated to the doctors prior to seeing the patients, so that they are prepared to talk with the patients in terms they can understand. This simple change could lead to big improvements in health outcomes.”

In future studies, the researchers hope to evaluate the cancer health literacy of Hispanic patients because prior research has pointed to disparities in this population’s health literacy.

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Doctor consults with cancer

patient and her father

Credit: Rhoda Baer

A new tool can identify patients with limited cancer health literacy, according to research published in the Journal of Health Communications.

The study authors noted that cancer patients are expected to play an active role in their care by adhering to medication regimens, distinguishing between scientifically credible medical evidence and misconceptions, and communicating with their providers about treatment decisions, risks, and survival rates.

However, patients with limited cancer health literacy can struggle with these responsibilities and potentially jeopardize their health by making uninformed decisions.

So Levent Dumenci, PhD, of Virginia Commonwealth University in Richmond, and his colleagues developed a tool to assess health literacy among cancer patients.

“Before now, there were only instruments that measured a particular aspect of general health literacy,” Dr Dumenci said. “It is important to have a tool that is specific to cancer because of the complex treatment options that cancer patients face, along with the increased demand for self-care.”

To meet that need, he and his colleagues developed the Cancer Health Literacy Test (CHLT)-30. The test, which is given via a touch-screen device, includes 30

questions about cancer treatment, medication side effects, and other cancer-related issues.

Six of the questions (CHLT-6) were specifically designed to quickly identify individuals with limited cancer health literacy.

The researchers tested the CHLT-30 in 1306 African American and Caucasian patients who were treated at oncology clinics in Virginia.

The team said the test accurately measured literacy and quickly identified patients with limited cancer health literacy. Eighteen percent of cancer patients had limited literacy, with an overrepresentation of African American, undereducated, and low-income patients.

“Using this tool, it takes just 1 to 2 minutes in the doctor’s office waiting room to identify patients with limited [cancer health literacy],” Dr Dumenci said. “Then, this information can be digitally communicated to the doctors prior to seeing the patients, so that they are prepared to talk with the patients in terms they can understand. This simple change could lead to big improvements in health outcomes.”

In future studies, the researchers hope to evaluate the cancer health literacy of Hispanic patients because prior research has pointed to disparities in this population’s health literacy.

Doctor consults with cancer

patient and her father

Credit: Rhoda Baer

A new tool can identify patients with limited cancer health literacy, according to research published in the Journal of Health Communications.

The study authors noted that cancer patients are expected to play an active role in their care by adhering to medication regimens, distinguishing between scientifically credible medical evidence and misconceptions, and communicating with their providers about treatment decisions, risks, and survival rates.

However, patients with limited cancer health literacy can struggle with these responsibilities and potentially jeopardize their health by making uninformed decisions.

So Levent Dumenci, PhD, of Virginia Commonwealth University in Richmond, and his colleagues developed a tool to assess health literacy among cancer patients.

“Before now, there were only instruments that measured a particular aspect of general health literacy,” Dr Dumenci said. “It is important to have a tool that is specific to cancer because of the complex treatment options that cancer patients face, along with the increased demand for self-care.”

To meet that need, he and his colleagues developed the Cancer Health Literacy Test (CHLT)-30. The test, which is given via a touch-screen device, includes 30

questions about cancer treatment, medication side effects, and other cancer-related issues.

Six of the questions (CHLT-6) were specifically designed to quickly identify individuals with limited cancer health literacy.

The researchers tested the CHLT-30 in 1306 African American and Caucasian patients who were treated at oncology clinics in Virginia.

The team said the test accurately measured literacy and quickly identified patients with limited cancer health literacy. Eighteen percent of cancer patients had limited literacy, with an overrepresentation of African American, undereducated, and low-income patients.

“Using this tool, it takes just 1 to 2 minutes in the doctor’s office waiting room to identify patients with limited [cancer health literacy],” Dr Dumenci said. “Then, this information can be digitally communicated to the doctors prior to seeing the patients, so that they are prepared to talk with the patients in terms they can understand. This simple change could lead to big improvements in health outcomes.”

In future studies, the researchers hope to evaluate the cancer health literacy of Hispanic patients because prior research has pointed to disparities in this population’s health literacy.

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