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Hematology analyzer cleared for use in US
Photo by William Weinert
The US Food and Drug Administration has granted 510(k) clearance for the BC-5390 Hematology Analyzer.
The product is designed to meet the testing needs of mid-volume hematology laboratories but offers features commonly found on large-volume analyzers.
The BC-5390 Hematology Analyzer provides a complete blood count with 21 parameters and a 5-part differential from a venous or capillary blood sample.
The product’s built-in autoloader has a 40-sample capacity, but it processes up to 60 samples per hour and stores up to 100,000 results with histograms.
The BC-5390 Hematology Analyzer’s barcode reader and optional laboratory information system connectivity enables seamless sample data transmission.
And nearly all scheduled maintenance procedures are automated by touch buttons.
The BC-5390 Hematology Analyzer is manufactured by Mindray, and MedTest will be the primary distributor of the analyzer in the US.
“We are excited to launch the BC-5390 Hematology Analyzer into the United States laboratory market,” said Caroline Li, general manager of Mindray IVD North America.
“The commercialization of the BC-5390 Hematology Analyzer in the US represents the first analyzer with a 5-part differential from Mindray.” 
Photo by William Weinert
The US Food and Drug Administration has granted 510(k) clearance for the BC-5390 Hematology Analyzer.
The product is designed to meet the testing needs of mid-volume hematology laboratories but offers features commonly found on large-volume analyzers.
The BC-5390 Hematology Analyzer provides a complete blood count with 21 parameters and a 5-part differential from a venous or capillary blood sample.
The product’s built-in autoloader has a 40-sample capacity, but it processes up to 60 samples per hour and stores up to 100,000 results with histograms.
The BC-5390 Hematology Analyzer’s barcode reader and optional laboratory information system connectivity enables seamless sample data transmission.
And nearly all scheduled maintenance procedures are automated by touch buttons.
The BC-5390 Hematology Analyzer is manufactured by Mindray, and MedTest will be the primary distributor of the analyzer in the US.
“We are excited to launch the BC-5390 Hematology Analyzer into the United States laboratory market,” said Caroline Li, general manager of Mindray IVD North America.
“The commercialization of the BC-5390 Hematology Analyzer in the US represents the first analyzer with a 5-part differential from Mindray.”
Photo by William Weinert
The US Food and Drug Administration has granted 510(k) clearance for the BC-5390 Hematology Analyzer.
The product is designed to meet the testing needs of mid-volume hematology laboratories but offers features commonly found on large-volume analyzers.
The BC-5390 Hematology Analyzer provides a complete blood count with 21 parameters and a 5-part differential from a venous or capillary blood sample.
The product’s built-in autoloader has a 40-sample capacity, but it processes up to 60 samples per hour and stores up to 100,000 results with histograms.
The BC-5390 Hematology Analyzer’s barcode reader and optional laboratory information system connectivity enables seamless sample data transmission.
And nearly all scheduled maintenance procedures are automated by touch buttons.
The BC-5390 Hematology Analyzer is manufactured by Mindray, and MedTest will be the primary distributor of the analyzer in the US.
“We are excited to launch the BC-5390 Hematology Analyzer into the United States laboratory market,” said Caroline Li, general manager of Mindray IVD North America.
“The commercialization of the BC-5390 Hematology Analyzer in the US represents the first analyzer with a 5-part differential from Mindray.”
HHS, NIH aim to increase clinical trial transparency
tumor in a test tube
Photo by Rhoda Baer
The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have announced new efforts to increase clinical trial transparency.
The HHS has issued a final rule that expands the legal requirements for registering certain clinical trials on ClinicalTrials.gov and providing summary results of these trials on the website.
The NIH has issued a complementary policy for registering and submitting summary results to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.
Both the HHS rule and the NIH policy will be effective on January 18, 2017.
“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD.
“The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants who do so much to help society advance knowledge and improve health.”
About the HHS rule
The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.
Requirements under the rule apply to most interventional studies of drug, biological, and device products regulated by the US Food and Drug Administration (FDA). The requirements do not apply to phase 1 trials of drug and biological products or small feasibility studies of device products.
Elements of the rule include:
- Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting the required information
- Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
- Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
- Requiring additional types of adverse event information
- Providing a list of potential legal consequences for non-compliance.
About the NIH policy
The NIH policy mandates that investigators conducting clinical trials funded by NIH (in whole or in part) will ensure that the trials are registered at ClinicalTrials.gov and that summary results of these trials are posted to the website within 12 months of the primary completion date (although this can be delayed for up to 2 years).
The policy applies to all NIH-funded trials, including phase 1 trials of FDA-regulated products and small feasibility device trials, as well as trials of products that are not regulated by the FDA, such as behavioral interventions.
tumor in a test tube
Photo by Rhoda Baer
The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have announced new efforts to increase clinical trial transparency.
The HHS has issued a final rule that expands the legal requirements for registering certain clinical trials on ClinicalTrials.gov and providing summary results of these trials on the website.
The NIH has issued a complementary policy for registering and submitting summary results to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.
Both the HHS rule and the NIH policy will be effective on January 18, 2017.
“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD.
“The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants who do so much to help society advance knowledge and improve health.”
About the HHS rule
The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.
Requirements under the rule apply to most interventional studies of drug, biological, and device products regulated by the US Food and Drug Administration (FDA). The requirements do not apply to phase 1 trials of drug and biological products or small feasibility studies of device products.
Elements of the rule include:
- Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting the required information
- Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
- Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
- Requiring additional types of adverse event information
- Providing a list of potential legal consequences for non-compliance.
About the NIH policy
The NIH policy mandates that investigators conducting clinical trials funded by NIH (in whole or in part) will ensure that the trials are registered at ClinicalTrials.gov and that summary results of these trials are posted to the website within 12 months of the primary completion date (although this can be delayed for up to 2 years).
The policy applies to all NIH-funded trials, including phase 1 trials of FDA-regulated products and small feasibility device trials, as well as trials of products that are not regulated by the FDA, such as behavioral interventions.
tumor in a test tube
Photo by Rhoda Baer
The US Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have announced new efforts to increase clinical trial transparency.
The HHS has issued a final rule that expands the legal requirements for registering certain clinical trials on ClinicalTrials.gov and providing summary results of these trials on the website.
The NIH has issued a complementary policy for registering and submitting summary results to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.
Both the HHS rule and the NIH policy will be effective on January 18, 2017.
“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD.
“The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants who do so much to help society advance knowledge and improve health.”
About the HHS rule
The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.
Requirements under the rule apply to most interventional studies of drug, biological, and device products regulated by the US Food and Drug Administration (FDA). The requirements do not apply to phase 1 trials of drug and biological products or small feasibility studies of device products.
Elements of the rule include:
- Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting the required information
- Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
- Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
- Requiring additional types of adverse event information
- Providing a list of potential legal consequences for non-compliance.
About the NIH policy
The NIH policy mandates that investigators conducting clinical trials funded by NIH (in whole or in part) will ensure that the trials are registered at ClinicalTrials.gov and that summary results of these trials are posted to the website within 12 months of the primary completion date (although this can be delayed for up to 2 years).
The policy applies to all NIH-funded trials, including phase 1 trials of FDA-regulated products and small feasibility device trials, as well as trials of products that are not regulated by the FDA, such as behavioral interventions.
Prophylaxis proves safer than screen-and-treat method
Photo by Nina Matthews
A new study suggests that treating pregnant women according to the results of malaria tests does not lower the risk of adverse pregnancy outcomes when compared to treating all women prophylactically.
In fact, the screen-and-treat approach, in which women received dihydroartemisinin-piperaquine (DP) only if they tested positive for malaria, was associated with higher fetal loss and more malaria at delivery than the prophylactic approach, in which women just received treatment with sulfadoxine-pyrimethamine (SP).
This is in spite of the fact that the study was conducted in an area of high SP resistance.
Feiko ter Kuile, MD, PhD, of the Liverpool School of Tropical Medicine in the UK, and his colleagues conducted this study and detailed the results in PLOS Medicine.
During pregnancy, undetected infection with malaria parasites can lead to maternal anemia, low birthweight, and fetal loss.
Therefore, in areas where malaria is endemic, the World Health Organization recommends treating pregnant women with SP. However, in some areas, more than 90% of Plasmodium parasites are resistant to SP.
In the current study, researchers compared this standard of care to a screening approach where pregnant women were tested for malaria using rapid diagnostic tests and treated with DP only if they tested positive for the parasite.
The study included 1873 HIV-negative pregnant women treated at 3 sites in Malawi, Africa. All of the women had 3 or 4 scheduled visits in the second and third trimester, 4 to 6 weeks apart.
The women were randomized to receive SP at each visit (n=921) or to be screened for malaria at every visit and treated with DP if they tested positive (n=923).
The prevalence of malaria at delivery was higher in the screening-DP group than in the SP group—48.7% and 40.8%, respectively (relative risk=1.19; P=0.007).
And fetal loss was higher in the screening-DP group than the SP group—2.6% and 1.3%, respectively (relative risk=2.06; P=0.046).
However, the risk of live adverse birth outcomes was similar between the screening-DP and SP groups—29.9% and 28.8%, respectively (relative risk=1.04, P=0.625).
The researchers said these results suggest that intermittent malaria screening and treatment with DP is not a viable strategy to replace intermittent preventive therapy with SP in malaria-endemic areas in sub-Saharan Africa, despite the high levels of resistance to SP.
Photo by Nina Matthews
A new study suggests that treating pregnant women according to the results of malaria tests does not lower the risk of adverse pregnancy outcomes when compared to treating all women prophylactically.
In fact, the screen-and-treat approach, in which women received dihydroartemisinin-piperaquine (DP) only if they tested positive for malaria, was associated with higher fetal loss and more malaria at delivery than the prophylactic approach, in which women just received treatment with sulfadoxine-pyrimethamine (SP).
This is in spite of the fact that the study was conducted in an area of high SP resistance.
Feiko ter Kuile, MD, PhD, of the Liverpool School of Tropical Medicine in the UK, and his colleagues conducted this study and detailed the results in PLOS Medicine.
During pregnancy, undetected infection with malaria parasites can lead to maternal anemia, low birthweight, and fetal loss.
Therefore, in areas where malaria is endemic, the World Health Organization recommends treating pregnant women with SP. However, in some areas, more than 90% of Plasmodium parasites are resistant to SP.
In the current study, researchers compared this standard of care to a screening approach where pregnant women were tested for malaria using rapid diagnostic tests and treated with DP only if they tested positive for the parasite.
The study included 1873 HIV-negative pregnant women treated at 3 sites in Malawi, Africa. All of the women had 3 or 4 scheduled visits in the second and third trimester, 4 to 6 weeks apart.
The women were randomized to receive SP at each visit (n=921) or to be screened for malaria at every visit and treated with DP if they tested positive (n=923).
The prevalence of malaria at delivery was higher in the screening-DP group than in the SP group—48.7% and 40.8%, respectively (relative risk=1.19; P=0.007).
And fetal loss was higher in the screening-DP group than the SP group—2.6% and 1.3%, respectively (relative risk=2.06; P=0.046).
However, the risk of live adverse birth outcomes was similar between the screening-DP and SP groups—29.9% and 28.8%, respectively (relative risk=1.04, P=0.625).
The researchers said these results suggest that intermittent malaria screening and treatment with DP is not a viable strategy to replace intermittent preventive therapy with SP in malaria-endemic areas in sub-Saharan Africa, despite the high levels of resistance to SP.
Photo by Nina Matthews
A new study suggests that treating pregnant women according to the results of malaria tests does not lower the risk of adverse pregnancy outcomes when compared to treating all women prophylactically.
In fact, the screen-and-treat approach, in which women received dihydroartemisinin-piperaquine (DP) only if they tested positive for malaria, was associated with higher fetal loss and more malaria at delivery than the prophylactic approach, in which women just received treatment with sulfadoxine-pyrimethamine (SP).
This is in spite of the fact that the study was conducted in an area of high SP resistance.
Feiko ter Kuile, MD, PhD, of the Liverpool School of Tropical Medicine in the UK, and his colleagues conducted this study and detailed the results in PLOS Medicine.
During pregnancy, undetected infection with malaria parasites can lead to maternal anemia, low birthweight, and fetal loss.
Therefore, in areas where malaria is endemic, the World Health Organization recommends treating pregnant women with SP. However, in some areas, more than 90% of Plasmodium parasites are resistant to SP.
In the current study, researchers compared this standard of care to a screening approach where pregnant women were tested for malaria using rapid diagnostic tests and treated with DP only if they tested positive for the parasite.
The study included 1873 HIV-negative pregnant women treated at 3 sites in Malawi, Africa. All of the women had 3 or 4 scheduled visits in the second and third trimester, 4 to 6 weeks apart.
The women were randomized to receive SP at each visit (n=921) or to be screened for malaria at every visit and treated with DP if they tested positive (n=923).
The prevalence of malaria at delivery was higher in the screening-DP group than in the SP group—48.7% and 40.8%, respectively (relative risk=1.19; P=0.007).
And fetal loss was higher in the screening-DP group than the SP group—2.6% and 1.3%, respectively (relative risk=2.06; P=0.046).
However, the risk of live adverse birth outcomes was similar between the screening-DP and SP groups—29.9% and 28.8%, respectively (relative risk=1.04, P=0.625).
The researchers said these results suggest that intermittent malaria screening and treatment with DP is not a viable strategy to replace intermittent preventive therapy with SP in malaria-endemic areas in sub-Saharan Africa, despite the high levels of resistance to SP.
Metric measures influence of research
Photo by Rhoda Baer
Researchers have developed a metric that uses citation rates to determine the influence of a scientific article.
The team says the metric, known as the Relative Citation Ratio (RCR), measures a scientific publication’s influence in a way that is article-level and field-independent.
George Santangelo, PhD, of the National Institutes of Health in Bethesda, Maryland, and his colleagues described this metric in PLOS Biology.
The researchers noted that citation is the primary mechanism for scientists to recognize the importance of each other’s work, but citation practices vary widely between fields.
RCR incorporates a novel method for field-normalization: the co-citation network. This network is formed from the reference lists of articles that cite the article in question.
For example, if Article X is cited by Article A, Article B, and Article C, the co-citation network of Article X would contain all the articles from the reference lists of Articles A, B, and C. Comparing the citation rate of Article X to the citation rate in the co-citation network allows each article to create its own individualized field.
In addition to using the co-citation network, RCR is also benchmarked to a peer comparison group so that it’s easy to determine the relative impact of an article.
The researchers said this benchmarking step is particularly important as it allows “apples-to-apples” comparisons for groups of papers; eg, comparing research output between similar types of institutions or between developing nations.
To test RCR, Dr Santangelo and his colleagues analyzed 88,835 articles published between 2003 and 2010.
The team said the National Institutes of Health awardees listed as authors of those articles “occupy relatively stable positions of influence across all disciplines.” Furthermore, the values generated by RCR correlated with the opinions of subject matter experts.
Still, the researchers acknowledged that RCR should not be used as a substitute for expert opinion.
“No number can fully represent the impact of an individual work or investigator,” Dr Santangelo said. “Neither RCR nor any other metric can quantitate the underlying value of a study nor measure the importance of making progress in solving a particular problem.”
Dr Santangelo said that, although expert opinion will remain the gold standard, RCR can assist in “the dissemination of a dynamic way to measure the influence of articles on their respective fields.”
A beta version of “iCite,” a web tool for calculating the RCR of articles listed in PubMed, is available at https://icite.od.nih.gov.
Photo by Rhoda Baer
Researchers have developed a metric that uses citation rates to determine the influence of a scientific article.
The team says the metric, known as the Relative Citation Ratio (RCR), measures a scientific publication’s influence in a way that is article-level and field-independent.
George Santangelo, PhD, of the National Institutes of Health in Bethesda, Maryland, and his colleagues described this metric in PLOS Biology.
The researchers noted that citation is the primary mechanism for scientists to recognize the importance of each other’s work, but citation practices vary widely between fields.
RCR incorporates a novel method for field-normalization: the co-citation network. This network is formed from the reference lists of articles that cite the article in question.
For example, if Article X is cited by Article A, Article B, and Article C, the co-citation network of Article X would contain all the articles from the reference lists of Articles A, B, and C. Comparing the citation rate of Article X to the citation rate in the co-citation network allows each article to create its own individualized field.
In addition to using the co-citation network, RCR is also benchmarked to a peer comparison group so that it’s easy to determine the relative impact of an article.
The researchers said this benchmarking step is particularly important as it allows “apples-to-apples” comparisons for groups of papers; eg, comparing research output between similar types of institutions or between developing nations.
To test RCR, Dr Santangelo and his colleagues analyzed 88,835 articles published between 2003 and 2010.
The team said the National Institutes of Health awardees listed as authors of those articles “occupy relatively stable positions of influence across all disciplines.” Furthermore, the values generated by RCR correlated with the opinions of subject matter experts.
Still, the researchers acknowledged that RCR should not be used as a substitute for expert opinion.
“No number can fully represent the impact of an individual work or investigator,” Dr Santangelo said. “Neither RCR nor any other metric can quantitate the underlying value of a study nor measure the importance of making progress in solving a particular problem.”
Dr Santangelo said that, although expert opinion will remain the gold standard, RCR can assist in “the dissemination of a dynamic way to measure the influence of articles on their respective fields.”
A beta version of “iCite,” a web tool for calculating the RCR of articles listed in PubMed, is available at https://icite.od.nih.gov.
Photo by Rhoda Baer
Researchers have developed a metric that uses citation rates to determine the influence of a scientific article.
The team says the metric, known as the Relative Citation Ratio (RCR), measures a scientific publication’s influence in a way that is article-level and field-independent.
George Santangelo, PhD, of the National Institutes of Health in Bethesda, Maryland, and his colleagues described this metric in PLOS Biology.
The researchers noted that citation is the primary mechanism for scientists to recognize the importance of each other’s work, but citation practices vary widely between fields.
RCR incorporates a novel method for field-normalization: the co-citation network. This network is formed from the reference lists of articles that cite the article in question.
For example, if Article X is cited by Article A, Article B, and Article C, the co-citation network of Article X would contain all the articles from the reference lists of Articles A, B, and C. Comparing the citation rate of Article X to the citation rate in the co-citation network allows each article to create its own individualized field.
In addition to using the co-citation network, RCR is also benchmarked to a peer comparison group so that it’s easy to determine the relative impact of an article.
The researchers said this benchmarking step is particularly important as it allows “apples-to-apples” comparisons for groups of papers; eg, comparing research output between similar types of institutions or between developing nations.
To test RCR, Dr Santangelo and his colleagues analyzed 88,835 articles published between 2003 and 2010.
The team said the National Institutes of Health awardees listed as authors of those articles “occupy relatively stable positions of influence across all disciplines.” Furthermore, the values generated by RCR correlated with the opinions of subject matter experts.
Still, the researchers acknowledged that RCR should not be used as a substitute for expert opinion.
“No number can fully represent the impact of an individual work or investigator,” Dr Santangelo said. “Neither RCR nor any other metric can quantitate the underlying value of a study nor measure the importance of making progress in solving a particular problem.”
Dr Santangelo said that, although expert opinion will remain the gold standard, RCR can assist in “the dissemination of a dynamic way to measure the influence of articles on their respective fields.”
A beta version of “iCite,” a web tool for calculating the RCR of articles listed in PubMed, is available at https://icite.od.nih.gov.
WHO certifies Sri Lanka malaria-free
Photo by James Gathany
The World Health Organization (WHO) has certified that Sri Lanka is now free of malaria.
Malaria was on the rise in Sri Lanka in the 1970s and 1980s. So, in the 1990s, the country adjusted its anti-malaria campaign.
The new strategy was to target the malaria parasite as well as the mosquitoes that spread the disease.
Sri Lanka set up mobile malaria clinics in high-transmission areas, which meant that prompt treatment could reduce the parasite reservoir and the possibility of further transmission.
Meanwhile, efforts to enhance surveillance, community engagement, and health education improved the ability of authorities to respond and mobilized popular support for the anti-malaria campaign.
Sri Lanka also received support from partners such as WHO and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
By 2006, Sri Lanka recorded less than 1000 cases of malaria per year. By October 2012, the indigenous cases were down to 0. For the past 3.5 years, no locally transmitted cases have been recorded.
“Sri Lanka’s achievement is truly remarkable,” said Dr Poonam Khetrapal Singh, WHO regional director for Southeast Asia. “In the mid-20th century, it was among the most malaria-affected countries, but now it is malaria-free.”
“This is a testament to the courage and vision of its leaders and signifies the great leaps that can be made when targeted action is taken. It also demonstrates the importance of grass-roots community engagement and a whole-of-society approach when it comes to making dramatic public health gains.”
To maintain elimination and ensure the malaria parasite is not reintroduced to Sri Lanka, the anti-malaria campaign is working closely with local authorities and international partners to maintain surveillance and response capacity and to screen high-risk populations entering the country.
Dr Khetrapal Singh said WHO will continue to support the efforts of Sri Lanka’s health authorities as they relate to malaria, as well as the country’s wider public health mission.
Sri Lanka is the second country in the WHO Southeast Asia region to eliminate malaria—after Maldives.
The announcement that Sri Lanka is malaria-free was made at the Sixty-ninth Session of the WHO Regional Committee for South-East Asia in Colombo, Sri Lanka, in the presence of health ministers and senior health officials from all 11 member states.
Photo by James Gathany
The World Health Organization (WHO) has certified that Sri Lanka is now free of malaria.
Malaria was on the rise in Sri Lanka in the 1970s and 1980s. So, in the 1990s, the country adjusted its anti-malaria campaign.
The new strategy was to target the malaria parasite as well as the mosquitoes that spread the disease.
Sri Lanka set up mobile malaria clinics in high-transmission areas, which meant that prompt treatment could reduce the parasite reservoir and the possibility of further transmission.
Meanwhile, efforts to enhance surveillance, community engagement, and health education improved the ability of authorities to respond and mobilized popular support for the anti-malaria campaign.
Sri Lanka also received support from partners such as WHO and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
By 2006, Sri Lanka recorded less than 1000 cases of malaria per year. By October 2012, the indigenous cases were down to 0. For the past 3.5 years, no locally transmitted cases have been recorded.
“Sri Lanka’s achievement is truly remarkable,” said Dr Poonam Khetrapal Singh, WHO regional director for Southeast Asia. “In the mid-20th century, it was among the most malaria-affected countries, but now it is malaria-free.”
“This is a testament to the courage and vision of its leaders and signifies the great leaps that can be made when targeted action is taken. It also demonstrates the importance of grass-roots community engagement and a whole-of-society approach when it comes to making dramatic public health gains.”
To maintain elimination and ensure the malaria parasite is not reintroduced to Sri Lanka, the anti-malaria campaign is working closely with local authorities and international partners to maintain surveillance and response capacity and to screen high-risk populations entering the country.
Dr Khetrapal Singh said WHO will continue to support the efforts of Sri Lanka’s health authorities as they relate to malaria, as well as the country’s wider public health mission.
Sri Lanka is the second country in the WHO Southeast Asia region to eliminate malaria—after Maldives.
The announcement that Sri Lanka is malaria-free was made at the Sixty-ninth Session of the WHO Regional Committee for South-East Asia in Colombo, Sri Lanka, in the presence of health ministers and senior health officials from all 11 member states.
Photo by James Gathany
The World Health Organization (WHO) has certified that Sri Lanka is now free of malaria.
Malaria was on the rise in Sri Lanka in the 1970s and 1980s. So, in the 1990s, the country adjusted its anti-malaria campaign.
The new strategy was to target the malaria parasite as well as the mosquitoes that spread the disease.
Sri Lanka set up mobile malaria clinics in high-transmission areas, which meant that prompt treatment could reduce the parasite reservoir and the possibility of further transmission.
Meanwhile, efforts to enhance surveillance, community engagement, and health education improved the ability of authorities to respond and mobilized popular support for the anti-malaria campaign.
Sri Lanka also received support from partners such as WHO and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
By 2006, Sri Lanka recorded less than 1000 cases of malaria per year. By October 2012, the indigenous cases were down to 0. For the past 3.5 years, no locally transmitted cases have been recorded.
“Sri Lanka’s achievement is truly remarkable,” said Dr Poonam Khetrapal Singh, WHO regional director for Southeast Asia. “In the mid-20th century, it was among the most malaria-affected countries, but now it is malaria-free.”
“This is a testament to the courage and vision of its leaders and signifies the great leaps that can be made when targeted action is taken. It also demonstrates the importance of grass-roots community engagement and a whole-of-society approach when it comes to making dramatic public health gains.”
To maintain elimination and ensure the malaria parasite is not reintroduced to Sri Lanka, the anti-malaria campaign is working closely with local authorities and international partners to maintain surveillance and response capacity and to screen high-risk populations entering the country.
Dr Khetrapal Singh said WHO will continue to support the efforts of Sri Lanka’s health authorities as they relate to malaria, as well as the country’s wider public health mission.
Sri Lanka is the second country in the WHO Southeast Asia region to eliminate malaria—after Maldives.
The announcement that Sri Lanka is malaria-free was made at the Sixty-ninth Session of the WHO Regional Committee for South-East Asia in Colombo, Sri Lanka, in the presence of health ministers and senior health officials from all 11 member states.
Effects of caring for advanced cancer patients
SAN FRANCISCO—Family caregivers of patients with high-mortality cancers may often experience high levels of depression and anxiety, results of a survey suggest.
The survey showed that caregivers can spend more than 8 hours a day providing care.
And as caregiving time increases, self-care behaviors such as sleep and exercise decline, which may confer poorer mental health.
These findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 239).
“Caregivers and patients are faced with an enormous physical and emotional toll when dealing with advanced cancer,” said study investigator J. Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham.
“When they put their own health and well-being on the back burner, it can affect their care to the patient.”
Dr Dionne-Odom and his colleagues conducted a cross-sectional survey of 294 family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head and neck, hematologic, or stage IV cancers.
The survey was fielded across 8 cancer centers in Alabama, Florida, and Tennessee. Survey questions explored measures of self-care behaviors and quality of life.
The caregivers had an average age of 66. They were mostly female (72.8%), white (91.2%), retired (54.4%), and the patient’s spouse/partner (60.2%). Nearly half of the caregivers lived in rural areas (46.9%), and more than half had annual incomes less than $50,000 (53.8%).
Most of the caregivers said they provided care 6 to 7 days a week (71%) for more than 1 year (68%).
Twenty-three percent of caregivers reported a high level of depressive symptoms, and 34% reported borderline or high levels of anxiety symptoms, associated with significantly lower scores for self-care.
Lower self-care behavior scores were associated with a longer overall duration of caregiving, more hours in the day spent caregiving, more days of the week spent caregiving, and with fair or poor patient health.
“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” Dr Dionne-Odom said. “These efforts would help ensure that caregivers are supported and healthy when they take on the important role of caring for an individual with advanced cancer.”
SAN FRANCISCO—Family caregivers of patients with high-mortality cancers may often experience high levels of depression and anxiety, results of a survey suggest.
The survey showed that caregivers can spend more than 8 hours a day providing care.
And as caregiving time increases, self-care behaviors such as sleep and exercise decline, which may confer poorer mental health.
These findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 239).
“Caregivers and patients are faced with an enormous physical and emotional toll when dealing with advanced cancer,” said study investigator J. Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham.
“When they put their own health and well-being on the back burner, it can affect their care to the patient.”
Dr Dionne-Odom and his colleagues conducted a cross-sectional survey of 294 family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head and neck, hematologic, or stage IV cancers.
The survey was fielded across 8 cancer centers in Alabama, Florida, and Tennessee. Survey questions explored measures of self-care behaviors and quality of life.
The caregivers had an average age of 66. They were mostly female (72.8%), white (91.2%), retired (54.4%), and the patient’s spouse/partner (60.2%). Nearly half of the caregivers lived in rural areas (46.9%), and more than half had annual incomes less than $50,000 (53.8%).
Most of the caregivers said they provided care 6 to 7 days a week (71%) for more than 1 year (68%).
Twenty-three percent of caregivers reported a high level of depressive symptoms, and 34% reported borderline or high levels of anxiety symptoms, associated with significantly lower scores for self-care.
Lower self-care behavior scores were associated with a longer overall duration of caregiving, more hours in the day spent caregiving, more days of the week spent caregiving, and with fair or poor patient health.
“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” Dr Dionne-Odom said. “These efforts would help ensure that caregivers are supported and healthy when they take on the important role of caring for an individual with advanced cancer.”
SAN FRANCISCO—Family caregivers of patients with high-mortality cancers may often experience high levels of depression and anxiety, results of a survey suggest.
The survey showed that caregivers can spend more than 8 hours a day providing care.
And as caregiving time increases, self-care behaviors such as sleep and exercise decline, which may confer poorer mental health.
These findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 239).
“Caregivers and patients are faced with an enormous physical and emotional toll when dealing with advanced cancer,” said study investigator J. Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham.
“When they put their own health and well-being on the back burner, it can affect their care to the patient.”
Dr Dionne-Odom and his colleagues conducted a cross-sectional survey of 294 family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head and neck, hematologic, or stage IV cancers.
The survey was fielded across 8 cancer centers in Alabama, Florida, and Tennessee. Survey questions explored measures of self-care behaviors and quality of life.
The caregivers had an average age of 66. They were mostly female (72.8%), white (91.2%), retired (54.4%), and the patient’s spouse/partner (60.2%). Nearly half of the caregivers lived in rural areas (46.9%), and more than half had annual incomes less than $50,000 (53.8%).
Most of the caregivers said they provided care 6 to 7 days a week (71%) for more than 1 year (68%).
Twenty-three percent of caregivers reported a high level of depressive symptoms, and 34% reported borderline or high levels of anxiety symptoms, associated with significantly lower scores for self-care.
Lower self-care behavior scores were associated with a longer overall duration of caregiving, more hours in the day spent caregiving, more days of the week spent caregiving, and with fair or poor patient health.
“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” Dr Dionne-Odom said. “These efforts would help ensure that caregivers are supported and healthy when they take on the important role of caring for an individual with advanced cancer.”
Study reveals barriers to accessing palliative care services
©ASCO/Todd Buchanan 2016
SAN FRANCISCO—Patients may face challenges when trying to access palliative and supportive care services at cancer centers, a new study suggests.
Researchers took a “mystery shopper” approach and placed calls to cancer centers inquiring about palliative and supportive care services for a family member.
The callers sometimes had difficulty obtaining information about these services, even though all of the centers offer them.
“It’s sobering to hear that such services are not readily accessible at many centers,” said study investigator Kathryn Hutchins, a medical student at Duke University in Durham, North Carolina.
“However, it provides an opportunity for cancer centers to empower their front-line staff, as well as the oncology care team, through education and training so that the entire enterprise has a common understanding of palliative care and how to access it.”
Hutchins and her colleagues presented this research at the 2016 Palliative Care in Oncology Symposium (abstract 122).
The researchers placed 160 calls to 40 major cancer centers. The team chose to focus on National Cancer Institute-designated cancer centers because they all provide palliative care services along with other supportive care services.
The researchers used the same script for every call, asking about services for a 58-year-old female who was recently diagnosed with inoperable liver cancer. The team called each center 4 times on different days.
In 38.2% of the calls, the researchers were not able to receive complete information about supportive care services.
In 9.5% of calls, cancer center staff gave an answer other than “yes” regarding the availability of palliative care services, even though such services were available.
The answers varied and included responses such as:
- Palliative care was for end-of-life patients only (n=2)
- No physicians specialized in symptom management (n=3)
- A medical record review would be needed first (n=2).
In addition, 10 staff members said they were unsure about the availability of palliative care, and 2 were unfamiliar with the term.
Overall, 37.6% of the callers were told that all 7 supportive care services they inquired about were offered.
“As oncologists, we like to believe that, when we refer patients to our institution’s helpline, they will get connected to the services they need, but that doesn’t always happen,” said study investigator Arif Kamal, MD, of Duke Cancer Institute.
“It’s important for oncologists to be aware of these barriers and to work to eliminate them.”
©ASCO/Todd Buchanan 2016
SAN FRANCISCO—Patients may face challenges when trying to access palliative and supportive care services at cancer centers, a new study suggests.
Researchers took a “mystery shopper” approach and placed calls to cancer centers inquiring about palliative and supportive care services for a family member.
The callers sometimes had difficulty obtaining information about these services, even though all of the centers offer them.
“It’s sobering to hear that such services are not readily accessible at many centers,” said study investigator Kathryn Hutchins, a medical student at Duke University in Durham, North Carolina.
“However, it provides an opportunity for cancer centers to empower their front-line staff, as well as the oncology care team, through education and training so that the entire enterprise has a common understanding of palliative care and how to access it.”
Hutchins and her colleagues presented this research at the 2016 Palliative Care in Oncology Symposium (abstract 122).
The researchers placed 160 calls to 40 major cancer centers. The team chose to focus on National Cancer Institute-designated cancer centers because they all provide palliative care services along with other supportive care services.
The researchers used the same script for every call, asking about services for a 58-year-old female who was recently diagnosed with inoperable liver cancer. The team called each center 4 times on different days.
In 38.2% of the calls, the researchers were not able to receive complete information about supportive care services.
In 9.5% of calls, cancer center staff gave an answer other than “yes” regarding the availability of palliative care services, even though such services were available.
The answers varied and included responses such as:
- Palliative care was for end-of-life patients only (n=2)
- No physicians specialized in symptom management (n=3)
- A medical record review would be needed first (n=2).
In addition, 10 staff members said they were unsure about the availability of palliative care, and 2 were unfamiliar with the term.
Overall, 37.6% of the callers were told that all 7 supportive care services they inquired about were offered.
“As oncologists, we like to believe that, when we refer patients to our institution’s helpline, they will get connected to the services they need, but that doesn’t always happen,” said study investigator Arif Kamal, MD, of Duke Cancer Institute.
“It’s important for oncologists to be aware of these barriers and to work to eliminate them.”
©ASCO/Todd Buchanan 2016
SAN FRANCISCO—Patients may face challenges when trying to access palliative and supportive care services at cancer centers, a new study suggests.
Researchers took a “mystery shopper” approach and placed calls to cancer centers inquiring about palliative and supportive care services for a family member.
The callers sometimes had difficulty obtaining information about these services, even though all of the centers offer them.
“It’s sobering to hear that such services are not readily accessible at many centers,” said study investigator Kathryn Hutchins, a medical student at Duke University in Durham, North Carolina.
“However, it provides an opportunity for cancer centers to empower their front-line staff, as well as the oncology care team, through education and training so that the entire enterprise has a common understanding of palliative care and how to access it.”
Hutchins and her colleagues presented this research at the 2016 Palliative Care in Oncology Symposium (abstract 122).
The researchers placed 160 calls to 40 major cancer centers. The team chose to focus on National Cancer Institute-designated cancer centers because they all provide palliative care services along with other supportive care services.
The researchers used the same script for every call, asking about services for a 58-year-old female who was recently diagnosed with inoperable liver cancer. The team called each center 4 times on different days.
In 38.2% of the calls, the researchers were not able to receive complete information about supportive care services.
In 9.5% of calls, cancer center staff gave an answer other than “yes” regarding the availability of palliative care services, even though such services were available.
The answers varied and included responses such as:
- Palliative care was for end-of-life patients only (n=2)
- No physicians specialized in symptom management (n=3)
- A medical record review would be needed first (n=2).
In addition, 10 staff members said they were unsure about the availability of palliative care, and 2 were unfamiliar with the term.
Overall, 37.6% of the callers were told that all 7 supportive care services they inquired about were offered.
“As oncologists, we like to believe that, when we refer patients to our institution’s helpline, they will get connected to the services they need, but that doesn’t always happen,” said study investigator Arif Kamal, MD, of Duke Cancer Institute.
“It’s important for oncologists to be aware of these barriers and to work to eliminate them.”
Cancer patients’ caregivers may carry greater burden
©ASCO/Todd Buchanan 2016
SAN FRANCISCO—New research suggests caring for a loved one with cancer may be more burdensome than caring for a loved one with a different condition.
Researchers analyzed data from “Caregiving in the U.S. 2015,” an online panel study of unpaid adult caregivers.
The team compared cancer and non-cancer caregivers to determine similarities and differences in characteristics and experiences.
The findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 4).
The study included 1248 caregivers, age 18 and older at the time they were surveyed, who provided care to an adult patient. Seven percent of these caregivers were looking after patients with cancer.
Cancer caregivers reported spending more hours per week providing care than non-cancer caregivers—32.9 and 23.9 hours, respectively.
In addition, cancer caregivers were more likely than other caregivers to communicate with healthcare professionals (82% and 62%, respectively), monitor and adjust patients’ care (76% and 66%, respectively), and advocate on behalf of patients (62% and 49%, respectively).
Despite high levels of engagement with providers, cancer caregivers were nearly twice as likely as non-cancer caregivers to report needing more help and information with making end-of-life decisions—40% and 21%, respectively.
“Our research demonstrates the ripple effect that cancer has on families and patient support systems,” said study investigator Erin Kent, PhD, of the National Cancer Institute in Rockville, Maryland.
“Caregiving can be extremely stressful and demanding—physically, emotionally, and financially. The data show we need to do a better job of supporting these individuals, as their wellbeing is essential to the patient’s quality of life and outcomes.”
Dr Kent emphasized the cyclical nature of cancer care, often requiring short, highly intense periods of time where patients undergo active treatment as a possible reason for the increased intensity in caregiving. She noted that such intensity is also associated with increased caregiver stress and depression.
“Based on our findings, it’s clear we need additional research on caregiving to better understand at what point providers and clinicians should intervene to assess the wellbeing of caregivers,” Dr Kent said.
“Technology, combined with use of a clinical distress rating system, could be promising in the future as a means to ensure caregivers are being supported in a meaningful way.”
©ASCO/Todd Buchanan 2016
SAN FRANCISCO—New research suggests caring for a loved one with cancer may be more burdensome than caring for a loved one with a different condition.
Researchers analyzed data from “Caregiving in the U.S. 2015,” an online panel study of unpaid adult caregivers.
The team compared cancer and non-cancer caregivers to determine similarities and differences in characteristics and experiences.
The findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 4).
The study included 1248 caregivers, age 18 and older at the time they were surveyed, who provided care to an adult patient. Seven percent of these caregivers were looking after patients with cancer.
Cancer caregivers reported spending more hours per week providing care than non-cancer caregivers—32.9 and 23.9 hours, respectively.
In addition, cancer caregivers were more likely than other caregivers to communicate with healthcare professionals (82% and 62%, respectively), monitor and adjust patients’ care (76% and 66%, respectively), and advocate on behalf of patients (62% and 49%, respectively).
Despite high levels of engagement with providers, cancer caregivers were nearly twice as likely as non-cancer caregivers to report needing more help and information with making end-of-life decisions—40% and 21%, respectively.
“Our research demonstrates the ripple effect that cancer has on families and patient support systems,” said study investigator Erin Kent, PhD, of the National Cancer Institute in Rockville, Maryland.
“Caregiving can be extremely stressful and demanding—physically, emotionally, and financially. The data show we need to do a better job of supporting these individuals, as their wellbeing is essential to the patient’s quality of life and outcomes.”
Dr Kent emphasized the cyclical nature of cancer care, often requiring short, highly intense periods of time where patients undergo active treatment as a possible reason for the increased intensity in caregiving. She noted that such intensity is also associated with increased caregiver stress and depression.
“Based on our findings, it’s clear we need additional research on caregiving to better understand at what point providers and clinicians should intervene to assess the wellbeing of caregivers,” Dr Kent said.
“Technology, combined with use of a clinical distress rating system, could be promising in the future as a means to ensure caregivers are being supported in a meaningful way.”
©ASCO/Todd Buchanan 2016
SAN FRANCISCO—New research suggests caring for a loved one with cancer may be more burdensome than caring for a loved one with a different condition.
Researchers analyzed data from “Caregiving in the U.S. 2015,” an online panel study of unpaid adult caregivers.
The team compared cancer and non-cancer caregivers to determine similarities and differences in characteristics and experiences.
The findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 4).
The study included 1248 caregivers, age 18 and older at the time they were surveyed, who provided care to an adult patient. Seven percent of these caregivers were looking after patients with cancer.
Cancer caregivers reported spending more hours per week providing care than non-cancer caregivers—32.9 and 23.9 hours, respectively.
In addition, cancer caregivers were more likely than other caregivers to communicate with healthcare professionals (82% and 62%, respectively), monitor and adjust patients’ care (76% and 66%, respectively), and advocate on behalf of patients (62% and 49%, respectively).
Despite high levels of engagement with providers, cancer caregivers were nearly twice as likely as non-cancer caregivers to report needing more help and information with making end-of-life decisions—40% and 21%, respectively.
“Our research demonstrates the ripple effect that cancer has on families and patient support systems,” said study investigator Erin Kent, PhD, of the National Cancer Institute in Rockville, Maryland.
“Caregiving can be extremely stressful and demanding—physically, emotionally, and financially. The data show we need to do a better job of supporting these individuals, as their wellbeing is essential to the patient’s quality of life and outcomes.”
Dr Kent emphasized the cyclical nature of cancer care, often requiring short, highly intense periods of time where patients undergo active treatment as a possible reason for the increased intensity in caregiving. She noted that such intensity is also associated with increased caregiver stress and depression.
“Based on our findings, it’s clear we need additional research on caregiving to better understand at what point providers and clinicians should intervene to assess the wellbeing of caregivers,” Dr Kent said.
“Technology, combined with use of a clinical distress rating system, could be promising in the future as a means to ensure caregivers are being supported in a meaningful way.”
Improving communication between cancer pts and docs
©ASCO/Todd Buchanan 2016
SAN FRANCISCO—Results of the VOICE study showed that training advanced cancer patients and their oncologists on how to communicate resulted in more clinically meaningful discussions between the parties.
However, these discussions did not significantly improve patients’ understanding of their prognosis, have a significant impact on their quality of life or end-of-life care, or significantly improve the
patient-physician relationship.
Ronald Epstein, MD, of the University of Rochester in New York, and his colleagues reported results from this study in JAMA Oncology and at the 2016 Palliative Care in Oncology Symposium (abstract 2).
The VOICE study included 265 patients with stage 3 or 4 cancer, 130 of whom received communication training. As part of the training, patients received a booklet Dr Epstein’s team wrote called “My Cancer Care: What Now? What Next? What I Prefer.”
The patients and their caregivers also met with social workers or nurses to discuss commonly asked questions and how to express their fears, for example, or how to be assertive and state their preferences.
Of the 38 oncologists studied, 19 received communication training. This included mock office sessions with actors (known as standardized patients), video training, and individualized feedback.
Later, the researchers audio-recorded real sessions between the oncologists and patients, then asked both groups to fill out questionnaires. The team coded the interactions and matched the scores to the goals of the training.
Results
The study’s primary endpoint was a composite of 4 communication measures—engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information.
The researchers found that communication training resulted in a significant improvement in this endpoint (P=0.02).
“We have shown, in the first large study of its kind, that it is possible to change the conversation in advanced cancer,” Dr Epstein said. “This is a huge first step.”
However, when Dr Epstein and his colleagues looked at the individual components of the endpoint, only the engaging measure was significantly different between the intervention and control groups.
Communication training had no significant effect on the patient-physician relationship, patients’ quality of life, or healthcare utilization at the end of life.
Likewise, communication training had no significant effect on patients’ understanding of their prognosis, which was assessed by the discordance in 2-year survival estimates and curability estimates between patients and physicians.
“We need to try harder to communicate well so that it’s harder to miscommunicate,” Dr Epstein said. “Simply having the conversation is not enough. The quality of the conversation will influence a mutual understanding between patients and their oncologists.”
The researchers said a limitation of this study may have been the timing of the training, which was only provided once and not timed to key decision points during patients’ trajectories. The effects of the training may have waned over the months, especially as the cancer progressed.
“We need to embed communication interventions into the fabric of everyday clinical care,” Dr Epstein said. “This does not take a lot of time, but, in our audio-recordings, there was precious little dialogue that reaffirmed the human experience and the needs of patients. The next step is to make good communication the rule, not the exception, so that cancer patients’ voices can be heard.”
©ASCO/Todd Buchanan 2016
SAN FRANCISCO—Results of the VOICE study showed that training advanced cancer patients and their oncologists on how to communicate resulted in more clinically meaningful discussions between the parties.
However, these discussions did not significantly improve patients’ understanding of their prognosis, have a significant impact on their quality of life or end-of-life care, or significantly improve the
patient-physician relationship.
Ronald Epstein, MD, of the University of Rochester in New York, and his colleagues reported results from this study in JAMA Oncology and at the 2016 Palliative Care in Oncology Symposium (abstract 2).
The VOICE study included 265 patients with stage 3 or 4 cancer, 130 of whom received communication training. As part of the training, patients received a booklet Dr Epstein’s team wrote called “My Cancer Care: What Now? What Next? What I Prefer.”
The patients and their caregivers also met with social workers or nurses to discuss commonly asked questions and how to express their fears, for example, or how to be assertive and state their preferences.
Of the 38 oncologists studied, 19 received communication training. This included mock office sessions with actors (known as standardized patients), video training, and individualized feedback.
Later, the researchers audio-recorded real sessions between the oncologists and patients, then asked both groups to fill out questionnaires. The team coded the interactions and matched the scores to the goals of the training.
Results
The study’s primary endpoint was a composite of 4 communication measures—engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information.
The researchers found that communication training resulted in a significant improvement in this endpoint (P=0.02).
“We have shown, in the first large study of its kind, that it is possible to change the conversation in advanced cancer,” Dr Epstein said. “This is a huge first step.”
However, when Dr Epstein and his colleagues looked at the individual components of the endpoint, only the engaging measure was significantly different between the intervention and control groups.
Communication training had no significant effect on the patient-physician relationship, patients’ quality of life, or healthcare utilization at the end of life.
Likewise, communication training had no significant effect on patients’ understanding of their prognosis, which was assessed by the discordance in 2-year survival estimates and curability estimates between patients and physicians.
“We need to try harder to communicate well so that it’s harder to miscommunicate,” Dr Epstein said. “Simply having the conversation is not enough. The quality of the conversation will influence a mutual understanding between patients and their oncologists.”
The researchers said a limitation of this study may have been the timing of the training, which was only provided once and not timed to key decision points during patients’ trajectories. The effects of the training may have waned over the months, especially as the cancer progressed.
“We need to embed communication interventions into the fabric of everyday clinical care,” Dr Epstein said. “This does not take a lot of time, but, in our audio-recordings, there was precious little dialogue that reaffirmed the human experience and the needs of patients. The next step is to make good communication the rule, not the exception, so that cancer patients’ voices can be heard.”
©ASCO/Todd Buchanan 2016
SAN FRANCISCO—Results of the VOICE study showed that training advanced cancer patients and their oncologists on how to communicate resulted in more clinically meaningful discussions between the parties.
However, these discussions did not significantly improve patients’ understanding of their prognosis, have a significant impact on their quality of life or end-of-life care, or significantly improve the
patient-physician relationship.
Ronald Epstein, MD, of the University of Rochester in New York, and his colleagues reported results from this study in JAMA Oncology and at the 2016 Palliative Care in Oncology Symposium (abstract 2).
The VOICE study included 265 patients with stage 3 or 4 cancer, 130 of whom received communication training. As part of the training, patients received a booklet Dr Epstein’s team wrote called “My Cancer Care: What Now? What Next? What I Prefer.”
The patients and their caregivers also met with social workers or nurses to discuss commonly asked questions and how to express their fears, for example, or how to be assertive and state their preferences.
Of the 38 oncologists studied, 19 received communication training. This included mock office sessions with actors (known as standardized patients), video training, and individualized feedback.
Later, the researchers audio-recorded real sessions between the oncologists and patients, then asked both groups to fill out questionnaires. The team coded the interactions and matched the scores to the goals of the training.
Results
The study’s primary endpoint was a composite of 4 communication measures—engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information.
The researchers found that communication training resulted in a significant improvement in this endpoint (P=0.02).
“We have shown, in the first large study of its kind, that it is possible to change the conversation in advanced cancer,” Dr Epstein said. “This is a huge first step.”
However, when Dr Epstein and his colleagues looked at the individual components of the endpoint, only the engaging measure was significantly different between the intervention and control groups.
Communication training had no significant effect on the patient-physician relationship, patients’ quality of life, or healthcare utilization at the end of life.
Likewise, communication training had no significant effect on patients’ understanding of their prognosis, which was assessed by the discordance in 2-year survival estimates and curability estimates between patients and physicians.
“We need to try harder to communicate well so that it’s harder to miscommunicate,” Dr Epstein said. “Simply having the conversation is not enough. The quality of the conversation will influence a mutual understanding between patients and their oncologists.”
The researchers said a limitation of this study may have been the timing of the training, which was only provided once and not timed to key decision points during patients’ trajectories. The effects of the training may have waned over the months, especially as the cancer progressed.
“We need to embed communication interventions into the fabric of everyday clinical care,” Dr Epstein said. “This does not take a lot of time, but, in our audio-recordings, there was precious little dialogue that reaffirmed the human experience and the needs of patients. The next step is to make good communication the rule, not the exception, so that cancer patients’ voices can be heard.”
Change may improve efficacy of malaria vaccine
Photo by Caitlin Kleiboer
Results of a phase 2 trial suggest that changing the dosing schedule can improve the efficacy of the malaria vaccine candidate RTS,S/AS01 (Mosquirix).
Researchers tested RTS,S/AS01 in 46 malaria-naïve US adults, using the controlled human malaria infection model (CHMI).
About 87% of subjects who received the modified dosing regimen were protected from malaria, compared to 63% of subjects who received the standard dosing schedule.
Jason Regules, MD, of the US Army Medical Research Institute of Infectious Diseases in Frederick, Maryland, and his colleagues reported these results in the Journal of Infectious Diseases.
The study was funded by GlaxoSmithKline, the US Military Infectious Disease Research Program, and the PATH Malaria Vaccine Initiative. RTS,S/AS01 is being developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative.
RTS,S/AS01 has been tested in trials of young children in Africa, and early results seemed promising. But long-term follow-up in a phase 2 study and a phase 3 study suggested the vaccine’s efficacy wanes over time.
Therefore, Dr Regules and his colleagues sought to determine if a novel immunization schedule—specifically, delaying RTS,S/AS01 administration and reducing dosage of the third vaccination, as well as any following booster dose—would significantly increase the vaccine’s ability to protect against infection.
The researchers evaluated RTS,S/AS01 in 46 malaria-naïve adults. First, the team immunized the subjects according to 2 regimens:
- A 0-, 1-, 7-month schedule with a fractional third dose (Fx017M)
- A 0-, 1-, 2-month schedule (012M, the current standard).
Following the third vaccination, subjects were exposed to malaria-causing parasites using CHMI, and the researchers evaluated the extent to which each regimen protected against infection.
During follow-up, the team assessed the efficacy of an additional fractional dose, or booster, in protecting against a second CHMI.
Twenty-six of the 30 subjects—86.7%—who received the Fx017M regimen and 10 of the 16—62.5%—who received the 012M regimen were protected from infection following the first CHMI.
In addition to providing more protection from malaria infection, the Fx017M regimen delayed infection longer than the 012M regimen.
About 90% of the Fx017M group who received a fourth fractional booster dose and underwent the second CHMI were protected from infection.
Four out of 5 subjects from both vaccination groups who were infected during the first CHMI were protected against the second, after receiving the fourth (fractional) dose of RTS,S/AS01.
The subjects did not report any serious health events as a result of receiving the vaccinations, and no safety concerns were associated with reducing dosages.
“With these results in hand, we are planning additional studies in the United States and Africa that will seek to further refine the dosing and schedule for maximum impact and to see whether these early stage results in American adults will translate into similarly high efficacy in sub-Saharan Africa, a region that bears much of the malaria disease burden,” said study author Ashley J. Birkett, PhD, director of PATH’s Malaria Vaccine Initiative.
“The results of these planned studies won’t be available for several years, however. It therefore remains critical that the pilot implementation for the recommended pediatric regimen of RTS,S/AS01, being led by the World Health Organization, moves forward as soon as possible. We need to help protect as many children as we can, as soon as we can, while we continue to pursue eradication—the only truly sustainable solution to malaria.”
Photo by Caitlin Kleiboer
Results of a phase 2 trial suggest that changing the dosing schedule can improve the efficacy of the malaria vaccine candidate RTS,S/AS01 (Mosquirix).
Researchers tested RTS,S/AS01 in 46 malaria-naïve US adults, using the controlled human malaria infection model (CHMI).
About 87% of subjects who received the modified dosing regimen were protected from malaria, compared to 63% of subjects who received the standard dosing schedule.
Jason Regules, MD, of the US Army Medical Research Institute of Infectious Diseases in Frederick, Maryland, and his colleagues reported these results in the Journal of Infectious Diseases.
The study was funded by GlaxoSmithKline, the US Military Infectious Disease Research Program, and the PATH Malaria Vaccine Initiative. RTS,S/AS01 is being developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative.
RTS,S/AS01 has been tested in trials of young children in Africa, and early results seemed promising. But long-term follow-up in a phase 2 study and a phase 3 study suggested the vaccine’s efficacy wanes over time.
Therefore, Dr Regules and his colleagues sought to determine if a novel immunization schedule—specifically, delaying RTS,S/AS01 administration and reducing dosage of the third vaccination, as well as any following booster dose—would significantly increase the vaccine’s ability to protect against infection.
The researchers evaluated RTS,S/AS01 in 46 malaria-naïve adults. First, the team immunized the subjects according to 2 regimens:
- A 0-, 1-, 7-month schedule with a fractional third dose (Fx017M)
- A 0-, 1-, 2-month schedule (012M, the current standard).
Following the third vaccination, subjects were exposed to malaria-causing parasites using CHMI, and the researchers evaluated the extent to which each regimen protected against infection.
During follow-up, the team assessed the efficacy of an additional fractional dose, or booster, in protecting against a second CHMI.
Twenty-six of the 30 subjects—86.7%—who received the Fx017M regimen and 10 of the 16—62.5%—who received the 012M regimen were protected from infection following the first CHMI.
In addition to providing more protection from malaria infection, the Fx017M regimen delayed infection longer than the 012M regimen.
About 90% of the Fx017M group who received a fourth fractional booster dose and underwent the second CHMI were protected from infection.
Four out of 5 subjects from both vaccination groups who were infected during the first CHMI were protected against the second, after receiving the fourth (fractional) dose of RTS,S/AS01.
The subjects did not report any serious health events as a result of receiving the vaccinations, and no safety concerns were associated with reducing dosages.
“With these results in hand, we are planning additional studies in the United States and Africa that will seek to further refine the dosing and schedule for maximum impact and to see whether these early stage results in American adults will translate into similarly high efficacy in sub-Saharan Africa, a region that bears much of the malaria disease burden,” said study author Ashley J. Birkett, PhD, director of PATH’s Malaria Vaccine Initiative.
“The results of these planned studies won’t be available for several years, however. It therefore remains critical that the pilot implementation for the recommended pediatric regimen of RTS,S/AS01, being led by the World Health Organization, moves forward as soon as possible. We need to help protect as many children as we can, as soon as we can, while we continue to pursue eradication—the only truly sustainable solution to malaria.”
Photo by Caitlin Kleiboer
Results of a phase 2 trial suggest that changing the dosing schedule can improve the efficacy of the malaria vaccine candidate RTS,S/AS01 (Mosquirix).
Researchers tested RTS,S/AS01 in 46 malaria-naïve US adults, using the controlled human malaria infection model (CHMI).
About 87% of subjects who received the modified dosing regimen were protected from malaria, compared to 63% of subjects who received the standard dosing schedule.
Jason Regules, MD, of the US Army Medical Research Institute of Infectious Diseases in Frederick, Maryland, and his colleagues reported these results in the Journal of Infectious Diseases.
The study was funded by GlaxoSmithKline, the US Military Infectious Disease Research Program, and the PATH Malaria Vaccine Initiative. RTS,S/AS01 is being developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative.
RTS,S/AS01 has been tested in trials of young children in Africa, and early results seemed promising. But long-term follow-up in a phase 2 study and a phase 3 study suggested the vaccine’s efficacy wanes over time.
Therefore, Dr Regules and his colleagues sought to determine if a novel immunization schedule—specifically, delaying RTS,S/AS01 administration and reducing dosage of the third vaccination, as well as any following booster dose—would significantly increase the vaccine’s ability to protect against infection.
The researchers evaluated RTS,S/AS01 in 46 malaria-naïve adults. First, the team immunized the subjects according to 2 regimens:
- A 0-, 1-, 7-month schedule with a fractional third dose (Fx017M)
- A 0-, 1-, 2-month schedule (012M, the current standard).
Following the third vaccination, subjects were exposed to malaria-causing parasites using CHMI, and the researchers evaluated the extent to which each regimen protected against infection.
During follow-up, the team assessed the efficacy of an additional fractional dose, or booster, in protecting against a second CHMI.
Twenty-six of the 30 subjects—86.7%—who received the Fx017M regimen and 10 of the 16—62.5%—who received the 012M regimen were protected from infection following the first CHMI.
In addition to providing more protection from malaria infection, the Fx017M regimen delayed infection longer than the 012M regimen.
About 90% of the Fx017M group who received a fourth fractional booster dose and underwent the second CHMI were protected from infection.
Four out of 5 subjects from both vaccination groups who were infected during the first CHMI were protected against the second, after receiving the fourth (fractional) dose of RTS,S/AS01.
The subjects did not report any serious health events as a result of receiving the vaccinations, and no safety concerns were associated with reducing dosages.
“With these results in hand, we are planning additional studies in the United States and Africa that will seek to further refine the dosing and schedule for maximum impact and to see whether these early stage results in American adults will translate into similarly high efficacy in sub-Saharan Africa, a region that bears much of the malaria disease burden,” said study author Ashley J. Birkett, PhD, director of PATH’s Malaria Vaccine Initiative.
“The results of these planned studies won’t be available for several years, however. It therefore remains critical that the pilot implementation for the recommended pediatric regimen of RTS,S/AS01, being led by the World Health Organization, moves forward as soon as possible. We need to help protect as many children as we can, as soon as we can, while we continue to pursue eradication—the only truly sustainable solution to malaria.”