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OSA tool uncovers risks of postoperative complications
High scores on the symptomless multivariable apnea prediction index (sMVAP) showed a strong correlation with increased risk for postsurgery complications, according to a study approved by the University of Pennsylvania, Philadelphia.
This validation helps assert the benefits of using the sMVAP as a tool to screen for obstructive sleep apnea (OSA) before elective inpatient surgeries, a test that is highly underutilized but very important, wrote M. Melanie Lyons, PhD, of the Center for Sleep and Circadian Neurobiology, University of Pennsylvania, Philadelphia, and her colleagues.
“Most patients having elective surgery are not screened for obstructive sleep apnea, even though OSA is a risk factor for postoperative complications,” wrote Dr. Lyons and her colleagues. “We observe that sMVAP correlates with higher risk for OSA, hypertension, and select postoperative complications, particularly in non-bariatric groups without routine preoperative screening for OSA.”
In a retrospective study of 40,432 patients undergoing elective surgery, high sMVAP scores were strongly correlated with postoperative complications including longer hospital stays (OR = 1.83), stays in the ICU (OR = 1.44), and respiratory complications (OR = 1.85) according to the researchers (Sleep. 2017 Jan 6. doi: 10.1093/sleep/zsw081).
Researchers separated participants into 10 categories according to the type of procedure: bariatric, orthopedic, cardiac, gastrointestinal, genitourinary, neurological, otorhinolaryngology/oral-maxillofacial/ear-nose-throat, pulmonary/thoracic, spine, and vascular.
The sMVAP calculates risk factors for OSA based on gender, age and body mass index, the researchers noted.
Those in the highest sMVAP score quintile were predominantly male (58%), with average age of 61 years, and average BMI of 40.9 kg/m2 (indicating morbid obesity). These patients reported the highest prevalence of having been previously diagnosed with OSA (26%). Comparatively, those patients in the lowest sMVAP quintile reported the lowest prevalence of an OSA diagnosis prior to undergoing their surgeries (9.3%).
Among non–bariatric surgery patients, those undergoing orthopedic procedures showed the highest correlation between complications and sMVAP scores.
The orthopedic surgery category reported a higher percentage of ICU-stay compared with bariatric surgery (14.3% vs 5.4%, P less than .0001), despite 23% of the patients who underwent an orthopedic surgery reporting previous OSA, compared with 50% of those who underwent surgery in the bariatric category.
This difference in previously reported OSA, according to Dr. Lyons and her colleagues, shows another example of the need for sMVAP in non–bariatric surgery preoperative procedure as a way to catch potentially undiagnosed OSA.
“[W]ork by Penn Bariatrics suggests that it is logical that the benefits of rigorous preoperative screening and diagnosis for OSA followed by a tailored team approach toward ensuring compliance toward treatment postoperation ... may be effective in limiting the likelihood of select postoperative complications,” the researchers wrote.
With 9.3% of all patients diagnosed with OSA, and a projected 14%-47% increase in specialty surgeries, there is an urgency in implementation of sMVAP and in conducting further studies, they noted.
This test was limited by the sample population, primarily male commercial truck drivers, the researchers noted. In addition, misclassification of OSA based on weight may have occurred in up to 20% of normal weight patients. Finally, data were collected from one hospital network, so generalizability may be limited.
Dr. M. Melanie Lyons and Dr. Junxin Li, another of the study’s authors, receive grants from the National Institutes of Health. The other authors reported no relevant disclosures.
High scores on the symptomless multivariable apnea prediction index (sMVAP) showed a strong correlation with increased risk for postsurgery complications, according to a study approved by the University of Pennsylvania, Philadelphia.
This validation helps assert the benefits of using the sMVAP as a tool to screen for obstructive sleep apnea (OSA) before elective inpatient surgeries, a test that is highly underutilized but very important, wrote M. Melanie Lyons, PhD, of the Center for Sleep and Circadian Neurobiology, University of Pennsylvania, Philadelphia, and her colleagues.
“Most patients having elective surgery are not screened for obstructive sleep apnea, even though OSA is a risk factor for postoperative complications,” wrote Dr. Lyons and her colleagues. “We observe that sMVAP correlates with higher risk for OSA, hypertension, and select postoperative complications, particularly in non-bariatric groups without routine preoperative screening for OSA.”
In a retrospective study of 40,432 patients undergoing elective surgery, high sMVAP scores were strongly correlated with postoperative complications including longer hospital stays (OR = 1.83), stays in the ICU (OR = 1.44), and respiratory complications (OR = 1.85) according to the researchers (Sleep. 2017 Jan 6. doi: 10.1093/sleep/zsw081).
Researchers separated participants into 10 categories according to the type of procedure: bariatric, orthopedic, cardiac, gastrointestinal, genitourinary, neurological, otorhinolaryngology/oral-maxillofacial/ear-nose-throat, pulmonary/thoracic, spine, and vascular.
The sMVAP calculates risk factors for OSA based on gender, age and body mass index, the researchers noted.
Those in the highest sMVAP score quintile were predominantly male (58%), with average age of 61 years, and average BMI of 40.9 kg/m2 (indicating morbid obesity). These patients reported the highest prevalence of having been previously diagnosed with OSA (26%). Comparatively, those patients in the lowest sMVAP quintile reported the lowest prevalence of an OSA diagnosis prior to undergoing their surgeries (9.3%).
Among non–bariatric surgery patients, those undergoing orthopedic procedures showed the highest correlation between complications and sMVAP scores.
The orthopedic surgery category reported a higher percentage of ICU-stay compared with bariatric surgery (14.3% vs 5.4%, P less than .0001), despite 23% of the patients who underwent an orthopedic surgery reporting previous OSA, compared with 50% of those who underwent surgery in the bariatric category.
This difference in previously reported OSA, according to Dr. Lyons and her colleagues, shows another example of the need for sMVAP in non–bariatric surgery preoperative procedure as a way to catch potentially undiagnosed OSA.
“[W]ork by Penn Bariatrics suggests that it is logical that the benefits of rigorous preoperative screening and diagnosis for OSA followed by a tailored team approach toward ensuring compliance toward treatment postoperation ... may be effective in limiting the likelihood of select postoperative complications,” the researchers wrote.
With 9.3% of all patients diagnosed with OSA, and a projected 14%-47% increase in specialty surgeries, there is an urgency in implementation of sMVAP and in conducting further studies, they noted.
This test was limited by the sample population, primarily male commercial truck drivers, the researchers noted. In addition, misclassification of OSA based on weight may have occurred in up to 20% of normal weight patients. Finally, data were collected from one hospital network, so generalizability may be limited.
Dr. M. Melanie Lyons and Dr. Junxin Li, another of the study’s authors, receive grants from the National Institutes of Health. The other authors reported no relevant disclosures.
High scores on the symptomless multivariable apnea prediction index (sMVAP) showed a strong correlation with increased risk for postsurgery complications, according to a study approved by the University of Pennsylvania, Philadelphia.
This validation helps assert the benefits of using the sMVAP as a tool to screen for obstructive sleep apnea (OSA) before elective inpatient surgeries, a test that is highly underutilized but very important, wrote M. Melanie Lyons, PhD, of the Center for Sleep and Circadian Neurobiology, University of Pennsylvania, Philadelphia, and her colleagues.
“Most patients having elective surgery are not screened for obstructive sleep apnea, even though OSA is a risk factor for postoperative complications,” wrote Dr. Lyons and her colleagues. “We observe that sMVAP correlates with higher risk for OSA, hypertension, and select postoperative complications, particularly in non-bariatric groups without routine preoperative screening for OSA.”
In a retrospective study of 40,432 patients undergoing elective surgery, high sMVAP scores were strongly correlated with postoperative complications including longer hospital stays (OR = 1.83), stays in the ICU (OR = 1.44), and respiratory complications (OR = 1.85) according to the researchers (Sleep. 2017 Jan 6. doi: 10.1093/sleep/zsw081).
Researchers separated participants into 10 categories according to the type of procedure: bariatric, orthopedic, cardiac, gastrointestinal, genitourinary, neurological, otorhinolaryngology/oral-maxillofacial/ear-nose-throat, pulmonary/thoracic, spine, and vascular.
The sMVAP calculates risk factors for OSA based on gender, age and body mass index, the researchers noted.
Those in the highest sMVAP score quintile were predominantly male (58%), with average age of 61 years, and average BMI of 40.9 kg/m2 (indicating morbid obesity). These patients reported the highest prevalence of having been previously diagnosed with OSA (26%). Comparatively, those patients in the lowest sMVAP quintile reported the lowest prevalence of an OSA diagnosis prior to undergoing their surgeries (9.3%).
Among non–bariatric surgery patients, those undergoing orthopedic procedures showed the highest correlation between complications and sMVAP scores.
The orthopedic surgery category reported a higher percentage of ICU-stay compared with bariatric surgery (14.3% vs 5.4%, P less than .0001), despite 23% of the patients who underwent an orthopedic surgery reporting previous OSA, compared with 50% of those who underwent surgery in the bariatric category.
This difference in previously reported OSA, according to Dr. Lyons and her colleagues, shows another example of the need for sMVAP in non–bariatric surgery preoperative procedure as a way to catch potentially undiagnosed OSA.
“[W]ork by Penn Bariatrics suggests that it is logical that the benefits of rigorous preoperative screening and diagnosis for OSA followed by a tailored team approach toward ensuring compliance toward treatment postoperation ... may be effective in limiting the likelihood of select postoperative complications,” the researchers wrote.
With 9.3% of all patients diagnosed with OSA, and a projected 14%-47% increase in specialty surgeries, there is an urgency in implementation of sMVAP and in conducting further studies, they noted.
This test was limited by the sample population, primarily male commercial truck drivers, the researchers noted. In addition, misclassification of OSA based on weight may have occurred in up to 20% of normal weight patients. Finally, data were collected from one hospital network, so generalizability may be limited.
Dr. M. Melanie Lyons and Dr. Junxin Li, another of the study’s authors, receive grants from the National Institutes of Health. The other authors reported no relevant disclosures.
FROM SLEEP
Key clinical point:
Major finding: Patients with high sMVAP scores had increased odds of complications, including extended length of stay (OR = 1.83), ICU stay (OR = 1.44), and respiratory complications (OR = 1.85).
Data source: Retrospective study of 40,432 elective surgery patient records collected from the Hospital of University of Pennsylvania, Pennsylvania Hospital, and Penn Presbyterian Medical Center between July 1, 2011, and June 30, 2014.
Disclosures: Dr. M. Melanie Lyons and Dr. Junxin Li receive grants from the National Institutes of Health. Other authors reported no relevant financial disclosures.
DNRs affect residents’ patient care decisions
Internal medicine residents reported being less likely to consider certain aggressive interventions outside of CPR on patients with do not resuscitate (DNR) and do not intubate (DNI) orders, according to a study.
These findings have researchers worried about a trend of doctors ignoring patient preferences, especially those who may have DNRs but do not want to ignore other treatment options, according to Elizabeth K. Stevenson, MD, of the Division of Pulmonary and Critical Care Medicine, North Shore Medical Center, Salem, Mass., and her colleagues.
“DNR/DNI patients were less likely to receive many invasive procedures, surgical consultations, or transfer to the ICU,” wrote Dr. Stevenson and her colleagues. “[D]ecisions to withhold many types of care not specified in DNR/DNI orders is concerning, given that the majority of patients with a DNR/DNI status in registry studies indicated they would accept other interventions beyond CPR and intubation.”
Researchers surveyed 553 internal medicine residents in the United States using an Internet survey that presented four vignettes describing clinical situations. Participants were asked to rank how likely they would be to employ listed intervention methods, from “strongly agree” to “strongly disagree,” in each scenario (Ann Am Thorac Soc. 2017, Apr;14[4]:536-42).
Two different versions of the survey were randomly assigned, varying only in terms of which vignettes included patients with a DNR/DNI order.
Of the interventions listed for each scenario, decisions to transfer patients to the intensive care unit and suggest surgery consultations showed the strongest association with code status.
“Residents were significantly less likely to indicate they would provide invasive procedures (including central venous catheter placement, esophagogastroduodenoscopy, colonoscopy, bronchoscopy, dialysis, and surgery consultation) to patients who had a status of DNR/DNI compared with Full Code,” the investigators noted. “In contrast, decisions to pursue noninvasive diagnostic or therapeutic interventions (CT scans, administration of oxygen or intravenous fluids, blood cultures, and initiation of anticoagulation) did not significantly differ by patient code status, with high levels of use across all vignettes.”
In one vignette involving surgical consultation for an 80-year-old woman with septic shock secondary to Clostridium difficile infection, 89.1% of residents recommended a consult for full-care patients, while 77.7% recommended one for a patient with a DNR/DNI (P = .0008).
Despite these findings, 94%-96% of participants reported willingness to consult with patients on their preferences before treatment decisions, which Dr. Stevenson and her peers found somewhat comforting, although it did not completely assuage them.
“Although the ideal approach would be to have more comprehensive discussion and documentation of patients’ goals of care in the outpatient setting, realistically, many patients will neither have had such discussions nor [have] completed advance directives before hospitalization,” investigators wrote.
The study was limited by the size of the sample, which numbered approximately 2% of the active internal medicine residents in the United States. The researchers recognized that these scenarios were theoretical, and that practicing physicians may act differently when faced with a medical situation in real life. The study also was limited by the concentration of respondents within a single program, as shared experiences or teachers may cause similar responses to theoretical situations, they wrote.
One of the study’s authors reports grants from the National Institutes of Health. The other investigators report no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets[polldaddy:9722880]
End-of-life treatment usually should be based on the preferences of the patients and how aggressive they want their physicians to be. Yet the study by Dr. Stevenson et al. shows that decisions in types of care are more often being based on the preferences of the doctors, which is very concerning. Engaging patients in a high-quality discussion of options and care preferences is an essential part of end-of-life treatment, and this trend of physician-attributable variation shows a level of paternalism that has no place in this type of care, and could lead to dire results for patients. For example, 72% of residents in one of the theoretical situations chose to intervene with dialysis in a full-code patient, while only 38% chose to do so for patients with a DNR. While the situations are theoretical, these findings uncover a disregard for patients’ autonomy in decisions about their own care. Since patients are unable to choose their own residents and many residents will not have the opportunity to consult with every patient, DNR patients are certainly vulnerable to the possibility of being assessed for treatment based on their code status. Residents are the future of medicine, and must be trained out of this habit so that patients’ preferences are not overlooked.
Joanna L. Hart, MD, is a research fellow in the Pulmonary, Allergy, and Critical Care Division, and the Palliative and Advanced Illness Research Center, University of Pennsylvania, Philadelphia. Meeta Prasad Kerlin, MD, MSCE, is the associate program director at the same institution. They had not disclosures. Their comments are in an editorial (Ann Am Thorac Soc. 2017 Apr;14[4]:491-2).
End-of-life treatment usually should be based on the preferences of the patients and how aggressive they want their physicians to be. Yet the study by Dr. Stevenson et al. shows that decisions in types of care are more often being based on the preferences of the doctors, which is very concerning. Engaging patients in a high-quality discussion of options and care preferences is an essential part of end-of-life treatment, and this trend of physician-attributable variation shows a level of paternalism that has no place in this type of care, and could lead to dire results for patients. For example, 72% of residents in one of the theoretical situations chose to intervene with dialysis in a full-code patient, while only 38% chose to do so for patients with a DNR. While the situations are theoretical, these findings uncover a disregard for patients’ autonomy in decisions about their own care. Since patients are unable to choose their own residents and many residents will not have the opportunity to consult with every patient, DNR patients are certainly vulnerable to the possibility of being assessed for treatment based on their code status. Residents are the future of medicine, and must be trained out of this habit so that patients’ preferences are not overlooked.
Joanna L. Hart, MD, is a research fellow in the Pulmonary, Allergy, and Critical Care Division, and the Palliative and Advanced Illness Research Center, University of Pennsylvania, Philadelphia. Meeta Prasad Kerlin, MD, MSCE, is the associate program director at the same institution. They had not disclosures. Their comments are in an editorial (Ann Am Thorac Soc. 2017 Apr;14[4]:491-2).
End-of-life treatment usually should be based on the preferences of the patients and how aggressive they want their physicians to be. Yet the study by Dr. Stevenson et al. shows that decisions in types of care are more often being based on the preferences of the doctors, which is very concerning. Engaging patients in a high-quality discussion of options and care preferences is an essential part of end-of-life treatment, and this trend of physician-attributable variation shows a level of paternalism that has no place in this type of care, and could lead to dire results for patients. For example, 72% of residents in one of the theoretical situations chose to intervene with dialysis in a full-code patient, while only 38% chose to do so for patients with a DNR. While the situations are theoretical, these findings uncover a disregard for patients’ autonomy in decisions about their own care. Since patients are unable to choose their own residents and many residents will not have the opportunity to consult with every patient, DNR patients are certainly vulnerable to the possibility of being assessed for treatment based on their code status. Residents are the future of medicine, and must be trained out of this habit so that patients’ preferences are not overlooked.
Joanna L. Hart, MD, is a research fellow in the Pulmonary, Allergy, and Critical Care Division, and the Palliative and Advanced Illness Research Center, University of Pennsylvania, Philadelphia. Meeta Prasad Kerlin, MD, MSCE, is the associate program director at the same institution. They had not disclosures. Their comments are in an editorial (Ann Am Thorac Soc. 2017 Apr;14[4]:491-2).
Internal medicine residents reported being less likely to consider certain aggressive interventions outside of CPR on patients with do not resuscitate (DNR) and do not intubate (DNI) orders, according to a study.
These findings have researchers worried about a trend of doctors ignoring patient preferences, especially those who may have DNRs but do not want to ignore other treatment options, according to Elizabeth K. Stevenson, MD, of the Division of Pulmonary and Critical Care Medicine, North Shore Medical Center, Salem, Mass., and her colleagues.
“DNR/DNI patients were less likely to receive many invasive procedures, surgical consultations, or transfer to the ICU,” wrote Dr. Stevenson and her colleagues. “[D]ecisions to withhold many types of care not specified in DNR/DNI orders is concerning, given that the majority of patients with a DNR/DNI status in registry studies indicated they would accept other interventions beyond CPR and intubation.”
Researchers surveyed 553 internal medicine residents in the United States using an Internet survey that presented four vignettes describing clinical situations. Participants were asked to rank how likely they would be to employ listed intervention methods, from “strongly agree” to “strongly disagree,” in each scenario (Ann Am Thorac Soc. 2017, Apr;14[4]:536-42).
Two different versions of the survey were randomly assigned, varying only in terms of which vignettes included patients with a DNR/DNI order.
Of the interventions listed for each scenario, decisions to transfer patients to the intensive care unit and suggest surgery consultations showed the strongest association with code status.
“Residents were significantly less likely to indicate they would provide invasive procedures (including central venous catheter placement, esophagogastroduodenoscopy, colonoscopy, bronchoscopy, dialysis, and surgery consultation) to patients who had a status of DNR/DNI compared with Full Code,” the investigators noted. “In contrast, decisions to pursue noninvasive diagnostic or therapeutic interventions (CT scans, administration of oxygen or intravenous fluids, blood cultures, and initiation of anticoagulation) did not significantly differ by patient code status, with high levels of use across all vignettes.”
In one vignette involving surgical consultation for an 80-year-old woman with septic shock secondary to Clostridium difficile infection, 89.1% of residents recommended a consult for full-care patients, while 77.7% recommended one for a patient with a DNR/DNI (P = .0008).
Despite these findings, 94%-96% of participants reported willingness to consult with patients on their preferences before treatment decisions, which Dr. Stevenson and her peers found somewhat comforting, although it did not completely assuage them.
“Although the ideal approach would be to have more comprehensive discussion and documentation of patients’ goals of care in the outpatient setting, realistically, many patients will neither have had such discussions nor [have] completed advance directives before hospitalization,” investigators wrote.
The study was limited by the size of the sample, which numbered approximately 2% of the active internal medicine residents in the United States. The researchers recognized that these scenarios were theoretical, and that practicing physicians may act differently when faced with a medical situation in real life. The study also was limited by the concentration of respondents within a single program, as shared experiences or teachers may cause similar responses to theoretical situations, they wrote.
One of the study’s authors reports grants from the National Institutes of Health. The other investigators report no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets[polldaddy:9722880]
Internal medicine residents reported being less likely to consider certain aggressive interventions outside of CPR on patients with do not resuscitate (DNR) and do not intubate (DNI) orders, according to a study.
These findings have researchers worried about a trend of doctors ignoring patient preferences, especially those who may have DNRs but do not want to ignore other treatment options, according to Elizabeth K. Stevenson, MD, of the Division of Pulmonary and Critical Care Medicine, North Shore Medical Center, Salem, Mass., and her colleagues.
“DNR/DNI patients were less likely to receive many invasive procedures, surgical consultations, or transfer to the ICU,” wrote Dr. Stevenson and her colleagues. “[D]ecisions to withhold many types of care not specified in DNR/DNI orders is concerning, given that the majority of patients with a DNR/DNI status in registry studies indicated they would accept other interventions beyond CPR and intubation.”
Researchers surveyed 553 internal medicine residents in the United States using an Internet survey that presented four vignettes describing clinical situations. Participants were asked to rank how likely they would be to employ listed intervention methods, from “strongly agree” to “strongly disagree,” in each scenario (Ann Am Thorac Soc. 2017, Apr;14[4]:536-42).
Two different versions of the survey were randomly assigned, varying only in terms of which vignettes included patients with a DNR/DNI order.
Of the interventions listed for each scenario, decisions to transfer patients to the intensive care unit and suggest surgery consultations showed the strongest association with code status.
“Residents were significantly less likely to indicate they would provide invasive procedures (including central venous catheter placement, esophagogastroduodenoscopy, colonoscopy, bronchoscopy, dialysis, and surgery consultation) to patients who had a status of DNR/DNI compared with Full Code,” the investigators noted. “In contrast, decisions to pursue noninvasive diagnostic or therapeutic interventions (CT scans, administration of oxygen or intravenous fluids, blood cultures, and initiation of anticoagulation) did not significantly differ by patient code status, with high levels of use across all vignettes.”
In one vignette involving surgical consultation for an 80-year-old woman with septic shock secondary to Clostridium difficile infection, 89.1% of residents recommended a consult for full-care patients, while 77.7% recommended one for a patient with a DNR/DNI (P = .0008).
Despite these findings, 94%-96% of participants reported willingness to consult with patients on their preferences before treatment decisions, which Dr. Stevenson and her peers found somewhat comforting, although it did not completely assuage them.
“Although the ideal approach would be to have more comprehensive discussion and documentation of patients’ goals of care in the outpatient setting, realistically, many patients will neither have had such discussions nor [have] completed advance directives before hospitalization,” investigators wrote.
The study was limited by the size of the sample, which numbered approximately 2% of the active internal medicine residents in the United States. The researchers recognized that these scenarios were theoretical, and that practicing physicians may act differently when faced with a medical situation in real life. The study also was limited by the concentration of respondents within a single program, as shared experiences or teachers may cause similar responses to theoretical situations, they wrote.
One of the study’s authors reports grants from the National Institutes of Health. The other investigators report no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets[polldaddy:9722880]
FROM ANNALS OF THE AMERICAN THORACIC SOCIETY
Key clinical point:
Major finding: Among 553 residents, patient code status was associated with invasive care decisions beyond intubation and CPR, especially transfers to the intensive care unit.
Data source: Randomized, cross-sectional Internet survey containing four clinical situations disseminated among internal medicine residents across the United States.
Disclosures: One of the study’s authors reports grants from the National Institutes of Health. The other investigators report no relevant financial disclosures.
FDA approves first home genetic health risk test
The Food and Drug Administration authorized 23andMe’s Personal Genome Service Genetic Health Risk (GHR) test, the first direct-to-consumer genetic screening test, according to a press release on Thursday, April 6.
FDA officials expect the product, which tests individuals for possible genetic predisposition for 10 diseases including Parkinson’s, late-onset Alzheimer’s, celiac disease, and hereditary hemochromatosis, to spur patients to consult with their physicians and make more informed lifestyle decisions.
“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in the release. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”
The FDA has exempted all further GHR tests developed by 23andMe from premarket review, noting future GHR tests developed by other makers, excluding those used for diagnostic purposes, may also achieve this exemption after submitting their first premarket review.
For the full details, see the original announcement.
[email protected]
On Twitter @EAZTweets
The Food and Drug Administration authorized 23andMe’s Personal Genome Service Genetic Health Risk (GHR) test, the first direct-to-consumer genetic screening test, according to a press release on Thursday, April 6.
FDA officials expect the product, which tests individuals for possible genetic predisposition for 10 diseases including Parkinson’s, late-onset Alzheimer’s, celiac disease, and hereditary hemochromatosis, to spur patients to consult with their physicians and make more informed lifestyle decisions.
“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in the release. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”
The FDA has exempted all further GHR tests developed by 23andMe from premarket review, noting future GHR tests developed by other makers, excluding those used for diagnostic purposes, may also achieve this exemption after submitting their first premarket review.
For the full details, see the original announcement.
[email protected]
On Twitter @EAZTweets
The Food and Drug Administration authorized 23andMe’s Personal Genome Service Genetic Health Risk (GHR) test, the first direct-to-consumer genetic screening test, according to a press release on Thursday, April 6.
FDA officials expect the product, which tests individuals for possible genetic predisposition for 10 diseases including Parkinson’s, late-onset Alzheimer’s, celiac disease, and hereditary hemochromatosis, to spur patients to consult with their physicians and make more informed lifestyle decisions.
“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in the release. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”
The FDA has exempted all further GHR tests developed by 23andMe from premarket review, noting future GHR tests developed by other makers, excluding those used for diagnostic purposes, may also achieve this exemption after submitting their first premarket review.
For the full details, see the original announcement.
[email protected]
On Twitter @EAZTweets
Fatigue in rheumatoid arthritis declines with pedometer use
Rheumatoid arthritis patients given pedometers reported a decrease in fatigue over a 21-week period, coupled with a small but significant increase in steps walked, according to a study from investigators at the University of California, San Francisco.
“Our results provide evidence that pedometers are effective at increasing physical activity among people with RA and provide support for the hypothesis that increasing physical activity by walking has important effects on fatigue and other RA symptoms,” wrote the researchers, led by Patricia Katz, PhD.
Patients who were given only pedometers increased their walking from baseline to week 21 by an average of 1,441 steps, while those given pedometers plus a step goal walked a mean of 1,656 steps additionally. The control group had a mean decrease of 747 steps.
Scores on the Patient-Reported Outcome Measurement Information System fatigue short form at 21 weeks declined by –3.2 for those who received pedometers only (P = .02) and by –4.8 for those who received pedometers plus a step goal (P = .0002), compared with the control group, which reported a decrease of –1.6 (P = .26).
While both intervention groups saw increased activity when compared with controls, patients given a step goal saw constant improvement, averaging an increase of 22 steps per week, while those without a step goal reported a decrease of 37 steps per week, which the researchers suspected could be from a larger initial increase in activity that could have discouraged a continued increase over time.
Dr. Katz and her associates said that the positive change that a rise in physical activity had on all other aspects of patients’ self-reported assessment shows promising results for the efficacy of exercise in patients, which some physicians had questioned.
“In the past, there was concern that physical activity or exercise might exacerbate rheumatoid arthritis symptoms, [however], our findings are similar to previous reports that exercise did not lead to worsened rheumatoid arthritis,” they wrote.
This study was limited by the small number of participants in the study, as well as the self-reported method of data collection. Researchers were also unable to gather activity intensity, as well as the amount of time patients wore the pedometer, causing the measure of adherence to “only be considered an estimate.”
The researchers reported technical difficulties with the devices, creating missing data.
The study was supported by the Rheumatology Research Foundation. The researchers reported no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
Rheumatoid arthritis patients given pedometers reported a decrease in fatigue over a 21-week period, coupled with a small but significant increase in steps walked, according to a study from investigators at the University of California, San Francisco.
“Our results provide evidence that pedometers are effective at increasing physical activity among people with RA and provide support for the hypothesis that increasing physical activity by walking has important effects on fatigue and other RA symptoms,” wrote the researchers, led by Patricia Katz, PhD.
Patients who were given only pedometers increased their walking from baseline to week 21 by an average of 1,441 steps, while those given pedometers plus a step goal walked a mean of 1,656 steps additionally. The control group had a mean decrease of 747 steps.
Scores on the Patient-Reported Outcome Measurement Information System fatigue short form at 21 weeks declined by –3.2 for those who received pedometers only (P = .02) and by –4.8 for those who received pedometers plus a step goal (P = .0002), compared with the control group, which reported a decrease of –1.6 (P = .26).
While both intervention groups saw increased activity when compared with controls, patients given a step goal saw constant improvement, averaging an increase of 22 steps per week, while those without a step goal reported a decrease of 37 steps per week, which the researchers suspected could be from a larger initial increase in activity that could have discouraged a continued increase over time.
Dr. Katz and her associates said that the positive change that a rise in physical activity had on all other aspects of patients’ self-reported assessment shows promising results for the efficacy of exercise in patients, which some physicians had questioned.
“In the past, there was concern that physical activity or exercise might exacerbate rheumatoid arthritis symptoms, [however], our findings are similar to previous reports that exercise did not lead to worsened rheumatoid arthritis,” they wrote.
This study was limited by the small number of participants in the study, as well as the self-reported method of data collection. Researchers were also unable to gather activity intensity, as well as the amount of time patients wore the pedometer, causing the measure of adherence to “only be considered an estimate.”
The researchers reported technical difficulties with the devices, creating missing data.
The study was supported by the Rheumatology Research Foundation. The researchers reported no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
Rheumatoid arthritis patients given pedometers reported a decrease in fatigue over a 21-week period, coupled with a small but significant increase in steps walked, according to a study from investigators at the University of California, San Francisco.
“Our results provide evidence that pedometers are effective at increasing physical activity among people with RA and provide support for the hypothesis that increasing physical activity by walking has important effects on fatigue and other RA symptoms,” wrote the researchers, led by Patricia Katz, PhD.
Patients who were given only pedometers increased their walking from baseline to week 21 by an average of 1,441 steps, while those given pedometers plus a step goal walked a mean of 1,656 steps additionally. The control group had a mean decrease of 747 steps.
Scores on the Patient-Reported Outcome Measurement Information System fatigue short form at 21 weeks declined by –3.2 for those who received pedometers only (P = .02) and by –4.8 for those who received pedometers plus a step goal (P = .0002), compared with the control group, which reported a decrease of –1.6 (P = .26).
While both intervention groups saw increased activity when compared with controls, patients given a step goal saw constant improvement, averaging an increase of 22 steps per week, while those without a step goal reported a decrease of 37 steps per week, which the researchers suspected could be from a larger initial increase in activity that could have discouraged a continued increase over time.
Dr. Katz and her associates said that the positive change that a rise in physical activity had on all other aspects of patients’ self-reported assessment shows promising results for the efficacy of exercise in patients, which some physicians had questioned.
“In the past, there was concern that physical activity or exercise might exacerbate rheumatoid arthritis symptoms, [however], our findings are similar to previous reports that exercise did not lead to worsened rheumatoid arthritis,” they wrote.
This study was limited by the small number of participants in the study, as well as the self-reported method of data collection. Researchers were also unable to gather activity intensity, as well as the amount of time patients wore the pedometer, causing the measure of adherence to “only be considered an estimate.”
The researchers reported technical difficulties with the devices, creating missing data.
The study was supported by the Rheumatology Research Foundation. The researchers reported no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
FROM ARTHRITIS CARE & RESEARCH
Key clinical point:
Major finding: Mean fatigue scores dropped –3.2 (P = .02) and –4.8 (P = .0002) for patients given only pedometers and pedometers with step goals, respectively.
Data source: Controlled study of 96 rheumatoid arthritis patients observed over a 21-week period.
Disclosures: The study was supported by the Rheumatology Research Foundation. The researchers reported no relevant financial disclosures.
Inpatient cost of atopic dermatitis called ‘substantial’
Inpatient care for atopic dermatitis in the U.S. totaled almost $128 million between 2002 and 2012, indicating a rising financial burden, according to a study funded by the Agency for Healthcare Research and Quality (AHRQ).
Cost of care averaged $8.3 million per year for adults and $3.3 million per year for children, with per-day costs for adult care increasing from $3,200 in 2002 to $3,783 in 2012 and per-day costs for pediatric care increasing from $2,430 to $2,914 in the same period, according to Shanthi Narla, a doctoral research fellow at Northwestern University, Chicago, and her colleagues (J Invest Dermatol. 2017 Mar 1. doi: 10.1016/j.jid.2017.02.975)
Growth in hospitalizations was seen especially in adult AD patients, which rose from 58 million to 76 million over the decade.
Despite such high comparative rates of hospitalization, most adult (80%) and child (97%) AD patients had a shorter average length of stay than those without AD (adults: 2.7 vs. 3.5 days; children: 2.4 vs. 2.7 days; P = .0004),
Growing prevalence of AD hospitalization contributed to the larger financial burden for AD patients, compared with psoriasis and pemphigus, the researchers noted, considering length of stay per AD hospitalization averaged 62.5% and 50% shorter than those for pemphigus or psoriasis.
“The acute signs and symptoms of [AD or eczema]... erythema, oozing/weeping, scaling and pruritus, may resolve faster with optimized treatment than vesicobullae and erosions in pemphigus or ‘lakes of pus’ and skin sloughing in generalized pustular psoriasis,” they wrote.
Additionally, hospitalization costs for AD were 60% and 33% of the cost per psoriasis and pemphigus hospitalizations, respectively, according to Ms. Narla and her colleagues.
The researchers said they were concerned that the prevalence of AD, and subsequently the inpatient financial burden, will continue to increase if left unchecked.
“Prevalences and costs of hospitalization for AD significantly increased during the study period without plateauing, indicating that the total cost of inpatient care for AD may continue to increase,” the researchers asserted.
This study was limited by a lack of information on the severity of patients’ symptoms, as well as whether a dermatologist or other physician diagnosed the patients and by which criteria.
[email protected]
On Twitter @EAZTweets
Inpatient care for atopic dermatitis in the U.S. totaled almost $128 million between 2002 and 2012, indicating a rising financial burden, according to a study funded by the Agency for Healthcare Research and Quality (AHRQ).
Cost of care averaged $8.3 million per year for adults and $3.3 million per year for children, with per-day costs for adult care increasing from $3,200 in 2002 to $3,783 in 2012 and per-day costs for pediatric care increasing from $2,430 to $2,914 in the same period, according to Shanthi Narla, a doctoral research fellow at Northwestern University, Chicago, and her colleagues (J Invest Dermatol. 2017 Mar 1. doi: 10.1016/j.jid.2017.02.975)
Growth in hospitalizations was seen especially in adult AD patients, which rose from 58 million to 76 million over the decade.
Despite such high comparative rates of hospitalization, most adult (80%) and child (97%) AD patients had a shorter average length of stay than those without AD (adults: 2.7 vs. 3.5 days; children: 2.4 vs. 2.7 days; P = .0004),
Growing prevalence of AD hospitalization contributed to the larger financial burden for AD patients, compared with psoriasis and pemphigus, the researchers noted, considering length of stay per AD hospitalization averaged 62.5% and 50% shorter than those for pemphigus or psoriasis.
“The acute signs and symptoms of [AD or eczema]... erythema, oozing/weeping, scaling and pruritus, may resolve faster with optimized treatment than vesicobullae and erosions in pemphigus or ‘lakes of pus’ and skin sloughing in generalized pustular psoriasis,” they wrote.
Additionally, hospitalization costs for AD were 60% and 33% of the cost per psoriasis and pemphigus hospitalizations, respectively, according to Ms. Narla and her colleagues.
The researchers said they were concerned that the prevalence of AD, and subsequently the inpatient financial burden, will continue to increase if left unchecked.
“Prevalences and costs of hospitalization for AD significantly increased during the study period without plateauing, indicating that the total cost of inpatient care for AD may continue to increase,” the researchers asserted.
This study was limited by a lack of information on the severity of patients’ symptoms, as well as whether a dermatologist or other physician diagnosed the patients and by which criteria.
[email protected]
On Twitter @EAZTweets
Inpatient care for atopic dermatitis in the U.S. totaled almost $128 million between 2002 and 2012, indicating a rising financial burden, according to a study funded by the Agency for Healthcare Research and Quality (AHRQ).
Cost of care averaged $8.3 million per year for adults and $3.3 million per year for children, with per-day costs for adult care increasing from $3,200 in 2002 to $3,783 in 2012 and per-day costs for pediatric care increasing from $2,430 to $2,914 in the same period, according to Shanthi Narla, a doctoral research fellow at Northwestern University, Chicago, and her colleagues (J Invest Dermatol. 2017 Mar 1. doi: 10.1016/j.jid.2017.02.975)
Growth in hospitalizations was seen especially in adult AD patients, which rose from 58 million to 76 million over the decade.
Despite such high comparative rates of hospitalization, most adult (80%) and child (97%) AD patients had a shorter average length of stay than those without AD (adults: 2.7 vs. 3.5 days; children: 2.4 vs. 2.7 days; P = .0004),
Growing prevalence of AD hospitalization contributed to the larger financial burden for AD patients, compared with psoriasis and pemphigus, the researchers noted, considering length of stay per AD hospitalization averaged 62.5% and 50% shorter than those for pemphigus or psoriasis.
“The acute signs and symptoms of [AD or eczema]... erythema, oozing/weeping, scaling and pruritus, may resolve faster with optimized treatment than vesicobullae and erosions in pemphigus or ‘lakes of pus’ and skin sloughing in generalized pustular psoriasis,” they wrote.
Additionally, hospitalization costs for AD were 60% and 33% of the cost per psoriasis and pemphigus hospitalizations, respectively, according to Ms. Narla and her colleagues.
The researchers said they were concerned that the prevalence of AD, and subsequently the inpatient financial burden, will continue to increase if left unchecked.
“Prevalences and costs of hospitalization for AD significantly increased during the study period without plateauing, indicating that the total cost of inpatient care for AD may continue to increase,” the researchers asserted.
This study was limited by a lack of information on the severity of patients’ symptoms, as well as whether a dermatologist or other physician diagnosed the patients and by which criteria.
[email protected]
On Twitter @EAZTweets
FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY
Key clinical point:
Major finding: Hospitalization costs for atopic dermatitis or eczema in adults and children in the U.S. totaled $127.8 million between 2002 and 2012.
Data source: Retrospective analysis of 87 million patient records from the 2002-2012 National Inpatient Sample, with cost of care adjusted for inflation.
Disclosures: Study was sponsored by the Agency for Healthcare Research and Quality (AHRQ), the Dermatology Foundation, and American Medical Association Foundation. The investigators report no relevant financial disclosures.
U.S. thyroid cancer incidence, mortality on the upswing
ORLANDO – with incidence-based mortality increasing by 1.1% annually from 1994 to 2013, according to a study conducted by the National Cancer Institute.
In a study of 77,726 patients diagnosed with thyroid cancer between 1974 and 2013, incidence rates increased from 4.56 per 100,000 person-years during 1974-1977 to 14.42 per 100,000 person-years during 2010-2013, according to Hyeyeun Lim, PhD, a postdoctoral fellow at National Cancer Institute, and colleagues (JAMA. 2017;317[13]:1338-48).
A majority of patients in the sample were female (75%) and white (82%); average age was 48 years.
A notable trend was the increase in papillary thyroid cancer (PTC). PTC was the most common thyroid cancer at 83.6% of diagnoses, followed by follicular, medullary, anaplastic, and other at 10.8%, 2.2%, 1.3%, and 2.1%, respectively. PTC was associated with the highest annual percent change (4.4%) and the only positive incidence-based mortality annual percent change (1.7%) among all histologic types, according to the researchers.
Regional and distant tumors accounted for 53.2% and 29% of deaths, respectively, compared to 13.5% for local tumors.
Dr. Lim and colleagues interpret the increase in incidence to contradict a common idea among researchers that attributes rising rates to new methods of detection such as ultrasound imaging and fine-needle aspiration biopsies.
“Such changes could account for the rapid increases in the incidence rates for localized and small PTCs that have been previously observed,” the researchers reported. “However, the significant, albeit less-rapid increase in advanced-stage and larger PTC incidence rates and increasing thyroid cancer mortality rates among patients diagnosed with advanced-stage PTC is not consistent with the notion that over-diagnosis is solely responsible for the changing trends in PTC incidence.”
While the researchers reported increased mortality rates among all PTC demographics, statistical significance was found solely in patients with distant disease (annual percentage changes, 2.9% [95% confidence interval, 1.1%-4.7%]), stage IV disease (APC, 12.9%[95%CI, 7.2%-19.0%]), or both, according to researchers.
Researchers speculate increased rates of obesity, childhood ionizing radiation exposure, and increased exposure to pesticides may be possible sources for increased rates of PTC, however Dr. Lim and peers assert further research must be conducted.
Based on these findings, researchers suggest “renewed focus on aggressive transdisciplinary management that includes surgery, adjuvant radioactive iodine, and, when indicated for the 5%-10% of patients who develop progressive disease, systemic therapy,” for patients with advanced-stage PTC.
Due to the nature of the study, researchers were limited to speculating potential reasons for increase in thyroid cancer incidence. Information of tumor size and stage was limited to the years when this information began to be recorded, after the initial years included in the study.
[email protected]
On Twitter @EAZTweets
ORLANDO – with incidence-based mortality increasing by 1.1% annually from 1994 to 2013, according to a study conducted by the National Cancer Institute.
In a study of 77,726 patients diagnosed with thyroid cancer between 1974 and 2013, incidence rates increased from 4.56 per 100,000 person-years during 1974-1977 to 14.42 per 100,000 person-years during 2010-2013, according to Hyeyeun Lim, PhD, a postdoctoral fellow at National Cancer Institute, and colleagues (JAMA. 2017;317[13]:1338-48).
A majority of patients in the sample were female (75%) and white (82%); average age was 48 years.
A notable trend was the increase in papillary thyroid cancer (PTC). PTC was the most common thyroid cancer at 83.6% of diagnoses, followed by follicular, medullary, anaplastic, and other at 10.8%, 2.2%, 1.3%, and 2.1%, respectively. PTC was associated with the highest annual percent change (4.4%) and the only positive incidence-based mortality annual percent change (1.7%) among all histologic types, according to the researchers.
Regional and distant tumors accounted for 53.2% and 29% of deaths, respectively, compared to 13.5% for local tumors.
Dr. Lim and colleagues interpret the increase in incidence to contradict a common idea among researchers that attributes rising rates to new methods of detection such as ultrasound imaging and fine-needle aspiration biopsies.
“Such changes could account for the rapid increases in the incidence rates for localized and small PTCs that have been previously observed,” the researchers reported. “However, the significant, albeit less-rapid increase in advanced-stage and larger PTC incidence rates and increasing thyroid cancer mortality rates among patients diagnosed with advanced-stage PTC is not consistent with the notion that over-diagnosis is solely responsible for the changing trends in PTC incidence.”
While the researchers reported increased mortality rates among all PTC demographics, statistical significance was found solely in patients with distant disease (annual percentage changes, 2.9% [95% confidence interval, 1.1%-4.7%]), stage IV disease (APC, 12.9%[95%CI, 7.2%-19.0%]), or both, according to researchers.
Researchers speculate increased rates of obesity, childhood ionizing radiation exposure, and increased exposure to pesticides may be possible sources for increased rates of PTC, however Dr. Lim and peers assert further research must be conducted.
Based on these findings, researchers suggest “renewed focus on aggressive transdisciplinary management that includes surgery, adjuvant radioactive iodine, and, when indicated for the 5%-10% of patients who develop progressive disease, systemic therapy,” for patients with advanced-stage PTC.
Due to the nature of the study, researchers were limited to speculating potential reasons for increase in thyroid cancer incidence. Information of tumor size and stage was limited to the years when this information began to be recorded, after the initial years included in the study.
[email protected]
On Twitter @EAZTweets
ORLANDO – with incidence-based mortality increasing by 1.1% annually from 1994 to 2013, according to a study conducted by the National Cancer Institute.
In a study of 77,726 patients diagnosed with thyroid cancer between 1974 and 2013, incidence rates increased from 4.56 per 100,000 person-years during 1974-1977 to 14.42 per 100,000 person-years during 2010-2013, according to Hyeyeun Lim, PhD, a postdoctoral fellow at National Cancer Institute, and colleagues (JAMA. 2017;317[13]:1338-48).
A majority of patients in the sample were female (75%) and white (82%); average age was 48 years.
A notable trend was the increase in papillary thyroid cancer (PTC). PTC was the most common thyroid cancer at 83.6% of diagnoses, followed by follicular, medullary, anaplastic, and other at 10.8%, 2.2%, 1.3%, and 2.1%, respectively. PTC was associated with the highest annual percent change (4.4%) and the only positive incidence-based mortality annual percent change (1.7%) among all histologic types, according to the researchers.
Regional and distant tumors accounted for 53.2% and 29% of deaths, respectively, compared to 13.5% for local tumors.
Dr. Lim and colleagues interpret the increase in incidence to contradict a common idea among researchers that attributes rising rates to new methods of detection such as ultrasound imaging and fine-needle aspiration biopsies.
“Such changes could account for the rapid increases in the incidence rates for localized and small PTCs that have been previously observed,” the researchers reported. “However, the significant, albeit less-rapid increase in advanced-stage and larger PTC incidence rates and increasing thyroid cancer mortality rates among patients diagnosed with advanced-stage PTC is not consistent with the notion that over-diagnosis is solely responsible for the changing trends in PTC incidence.”
While the researchers reported increased mortality rates among all PTC demographics, statistical significance was found solely in patients with distant disease (annual percentage changes, 2.9% [95% confidence interval, 1.1%-4.7%]), stage IV disease (APC, 12.9%[95%CI, 7.2%-19.0%]), or both, according to researchers.
Researchers speculate increased rates of obesity, childhood ionizing radiation exposure, and increased exposure to pesticides may be possible sources for increased rates of PTC, however Dr. Lim and peers assert further research must be conducted.
Based on these findings, researchers suggest “renewed focus on aggressive transdisciplinary management that includes surgery, adjuvant radioactive iodine, and, when indicated for the 5%-10% of patients who develop progressive disease, systemic therapy,” for patients with advanced-stage PTC.
Due to the nature of the study, researchers were limited to speculating potential reasons for increase in thyroid cancer incidence. Information of tumor size and stage was limited to the years when this information began to be recorded, after the initial years included in the study.
[email protected]
On Twitter @EAZTweets
AT ENDO 2017
Key clinical point:
Major finding: Thyroid cancer incidence increased 3.6% from 1974 to 2013 and incidence-based mortality increased by 1.1% per year from 1994 to 2013.
Data source: A retrospective study of 77,726 patient records attained from Surveillance, Epidemiology, and End Results–9 cancer registry database, analyzed via log-linear regression.
Disclosures: Dr. Julie Sosa reported being on the Data Monitoring Committee of the Medullary Thyroid Cancer Consortium Registry, which is sponsored by AstraZeneca, Eli Lilly, GlaxoSmithKline, and Novo Nordisk.
Heat-stable rotavirus vaccine shows promising results
A new low-cost rotavirus gastroenteritis vaccine that does not require cold storage showed a vaccine efficacy of 67% in a per-protocol test of 3,508 Nigerien infants, according to a study by Sheila Isanaka of the department of research at Epicentre, Paris, and her associates.
In a double blind, placebo-controlled test of the oral bovine rotavirus pentavalent vaccine (BRV-PV), 31 severe cases of rotavirus were found in the vaccinated group of 1,780, while 87 cases were found in the placebo group of 1,728 (2.14 vs. 6.44 cases per 100 person-years, respectively), according to Ms. Isanaka and her colleagues (N Engl J Med. 2017 Mar 23;376[12]:1121-30).
Researchers gathered infants with severe symptoms and administered three injections of either BRV-PV or the placebo from August 2014 through November 2015. The BRV-PV vaccine, manufactured by Serum Institute of India, contains the rotavirus serotypes G1, G2, G3, G4, and G9.
With regard to adverse events, there was no distinction between the two groups (P greater than .15). According to medical investigators, the most common cause of deaths – 27 and 22 in the vaccine and placebo groups, respectively – was infections and infestations (in 37 infants) and metabolism and nutrition disorders (in 6).
Part of what makes this vaccine unique is its shelf life of 2 years when kept at 37° C, or 6 months at 40° C, a key point for Ms. Isanaka and her colleagues.
“The global supply of the vaccines is constrained, and unreliable transportation and storage systems make delivery of vaccines that require refrigeration difficult,” Ms. Isanaka and her colleagues reported. “The introduction of BRV-PV may help to minimize the burden on already strained immunization programs.” The vaccine is also “for sale at or below the current price of the two WHO prequalified vaccines that are supported by the Gavi alliance,” making it possibly more financially accessible as well.
While the per-protocol test found efficacy at 67%, the intention-to-treat population reported a higher efficacy of 73%. Ms. Isanaka and her colleagues believe this number “may more closely represent the efficacy under real-world conditions,” due to the more flexible vaccination schedule.
This study was limited by a short time frame, which did not allow researchers to gather genotyping data pertaining to the efficacy against changing serotypes. BRV-PV also was not given consistently with the oral polio vaccine.
The study was supported by Médecins sans Frontières Operational Center in Geneva and the Kavli Foundation. Ms. Isanaka’s institution, Epicentre, receives core funding from Médecins sans Frontières. Ms. McNeal reports grant support from Epicentre for the study, and other support from Merck and GlaxoSmithKline outside the submitted work. None of the other researchers had relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
Rotavirus is the leading cause of diarrhea-associated death in children aged under 5 years, and with 85% of all deaths occurring in Africa and Asia, proper channels of vaccine dissemination are critical. There is no question to the positive influence of rotavirus vaccines, as research suggests they could save 2.46 million children’s lives and prevent another 83 million from living with a disability between 2011 and 2030.
While two vaccines, Rotarix and RotaTeq, are already being introduced to patients in 48 countries, diminishing vaccine uptake is standing in the way of these interventions reaching their full potential. Despite subsidies from Gavi (the vaccine alliance) and the World Health Organization, costs are still too high and the necessity for cold storage poses a financial and logistical problem for a majority of high risk countries. The BRV-PV vaccine developed by Serum Institute of India seems to be a step in the right direction in helping to ease this burden.
While its efficacy is modest, BRV-PV has shown promise through its heat stability as well as its cost, which falls between the prices of the two already available vaccines.
It is not perfect; as a freeze-dried vaccine, it may pose problems in areas where oral liquid, all-in-one vaccinations are preferred. Yet, there is no doubt that an increase in affordable, programmatically suitable options will help achieve the goal of ending rotavirus related deaths globally.
Mathuram Santosham, MD, is professor of pediatrics and pediatric infectious diseases at Johns Hopkins University, Baltimore. Duncan Steele, PhD, is a microbiologist and deputy director and strategic lead for enteric vaccines and enteric and diarrheal diseases for the Bill & Melinda Gates Foundation, Seattle. They coauthored the editorial regarding the article by Isanaka et al. (N Engl J Med. 2017 March 23;376[12]:1170-2). Dr. Santosham reported no relevant financial disclosures. Dr. Steele reports that he is employed at the Bill & Melinda Gates Foundation, which has supported through funding, the development of multiple rotavirus vaccine candidates including the lyophilized rotavirus vaccine produced by Serum Institute.
Rotavirus is the leading cause of diarrhea-associated death in children aged under 5 years, and with 85% of all deaths occurring in Africa and Asia, proper channels of vaccine dissemination are critical. There is no question to the positive influence of rotavirus vaccines, as research suggests they could save 2.46 million children’s lives and prevent another 83 million from living with a disability between 2011 and 2030.
While two vaccines, Rotarix and RotaTeq, are already being introduced to patients in 48 countries, diminishing vaccine uptake is standing in the way of these interventions reaching their full potential. Despite subsidies from Gavi (the vaccine alliance) and the World Health Organization, costs are still too high and the necessity for cold storage poses a financial and logistical problem for a majority of high risk countries. The BRV-PV vaccine developed by Serum Institute of India seems to be a step in the right direction in helping to ease this burden.
While its efficacy is modest, BRV-PV has shown promise through its heat stability as well as its cost, which falls between the prices of the two already available vaccines.
It is not perfect; as a freeze-dried vaccine, it may pose problems in areas where oral liquid, all-in-one vaccinations are preferred. Yet, there is no doubt that an increase in affordable, programmatically suitable options will help achieve the goal of ending rotavirus related deaths globally.
Mathuram Santosham, MD, is professor of pediatrics and pediatric infectious diseases at Johns Hopkins University, Baltimore. Duncan Steele, PhD, is a microbiologist and deputy director and strategic lead for enteric vaccines and enteric and diarrheal diseases for the Bill & Melinda Gates Foundation, Seattle. They coauthored the editorial regarding the article by Isanaka et al. (N Engl J Med. 2017 March 23;376[12]:1170-2). Dr. Santosham reported no relevant financial disclosures. Dr. Steele reports that he is employed at the Bill & Melinda Gates Foundation, which has supported through funding, the development of multiple rotavirus vaccine candidates including the lyophilized rotavirus vaccine produced by Serum Institute.
Rotavirus is the leading cause of diarrhea-associated death in children aged under 5 years, and with 85% of all deaths occurring in Africa and Asia, proper channels of vaccine dissemination are critical. There is no question to the positive influence of rotavirus vaccines, as research suggests they could save 2.46 million children’s lives and prevent another 83 million from living with a disability between 2011 and 2030.
While two vaccines, Rotarix and RotaTeq, are already being introduced to patients in 48 countries, diminishing vaccine uptake is standing in the way of these interventions reaching their full potential. Despite subsidies from Gavi (the vaccine alliance) and the World Health Organization, costs are still too high and the necessity for cold storage poses a financial and logistical problem for a majority of high risk countries. The BRV-PV vaccine developed by Serum Institute of India seems to be a step in the right direction in helping to ease this burden.
While its efficacy is modest, BRV-PV has shown promise through its heat stability as well as its cost, which falls between the prices of the two already available vaccines.
It is not perfect; as a freeze-dried vaccine, it may pose problems in areas where oral liquid, all-in-one vaccinations are preferred. Yet, there is no doubt that an increase in affordable, programmatically suitable options will help achieve the goal of ending rotavirus related deaths globally.
Mathuram Santosham, MD, is professor of pediatrics and pediatric infectious diseases at Johns Hopkins University, Baltimore. Duncan Steele, PhD, is a microbiologist and deputy director and strategic lead for enteric vaccines and enteric and diarrheal diseases for the Bill & Melinda Gates Foundation, Seattle. They coauthored the editorial regarding the article by Isanaka et al. (N Engl J Med. 2017 March 23;376[12]:1170-2). Dr. Santosham reported no relevant financial disclosures. Dr. Steele reports that he is employed at the Bill & Melinda Gates Foundation, which has supported through funding, the development of multiple rotavirus vaccine candidates including the lyophilized rotavirus vaccine produced by Serum Institute.
A new low-cost rotavirus gastroenteritis vaccine that does not require cold storage showed a vaccine efficacy of 67% in a per-protocol test of 3,508 Nigerien infants, according to a study by Sheila Isanaka of the department of research at Epicentre, Paris, and her associates.
In a double blind, placebo-controlled test of the oral bovine rotavirus pentavalent vaccine (BRV-PV), 31 severe cases of rotavirus were found in the vaccinated group of 1,780, while 87 cases were found in the placebo group of 1,728 (2.14 vs. 6.44 cases per 100 person-years, respectively), according to Ms. Isanaka and her colleagues (N Engl J Med. 2017 Mar 23;376[12]:1121-30).
Researchers gathered infants with severe symptoms and administered three injections of either BRV-PV or the placebo from August 2014 through November 2015. The BRV-PV vaccine, manufactured by Serum Institute of India, contains the rotavirus serotypes G1, G2, G3, G4, and G9.
With regard to adverse events, there was no distinction between the two groups (P greater than .15). According to medical investigators, the most common cause of deaths – 27 and 22 in the vaccine and placebo groups, respectively – was infections and infestations (in 37 infants) and metabolism and nutrition disorders (in 6).
Part of what makes this vaccine unique is its shelf life of 2 years when kept at 37° C, or 6 months at 40° C, a key point for Ms. Isanaka and her colleagues.
“The global supply of the vaccines is constrained, and unreliable transportation and storage systems make delivery of vaccines that require refrigeration difficult,” Ms. Isanaka and her colleagues reported. “The introduction of BRV-PV may help to minimize the burden on already strained immunization programs.” The vaccine is also “for sale at or below the current price of the two WHO prequalified vaccines that are supported by the Gavi alliance,” making it possibly more financially accessible as well.
While the per-protocol test found efficacy at 67%, the intention-to-treat population reported a higher efficacy of 73%. Ms. Isanaka and her colleagues believe this number “may more closely represent the efficacy under real-world conditions,” due to the more flexible vaccination schedule.
This study was limited by a short time frame, which did not allow researchers to gather genotyping data pertaining to the efficacy against changing serotypes. BRV-PV also was not given consistently with the oral polio vaccine.
The study was supported by Médecins sans Frontières Operational Center in Geneva and the Kavli Foundation. Ms. Isanaka’s institution, Epicentre, receives core funding from Médecins sans Frontières. Ms. McNeal reports grant support from Epicentre for the study, and other support from Merck and GlaxoSmithKline outside the submitted work. None of the other researchers had relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
A new low-cost rotavirus gastroenteritis vaccine that does not require cold storage showed a vaccine efficacy of 67% in a per-protocol test of 3,508 Nigerien infants, according to a study by Sheila Isanaka of the department of research at Epicentre, Paris, and her associates.
In a double blind, placebo-controlled test of the oral bovine rotavirus pentavalent vaccine (BRV-PV), 31 severe cases of rotavirus were found in the vaccinated group of 1,780, while 87 cases were found in the placebo group of 1,728 (2.14 vs. 6.44 cases per 100 person-years, respectively), according to Ms. Isanaka and her colleagues (N Engl J Med. 2017 Mar 23;376[12]:1121-30).
Researchers gathered infants with severe symptoms and administered three injections of either BRV-PV or the placebo from August 2014 through November 2015. The BRV-PV vaccine, manufactured by Serum Institute of India, contains the rotavirus serotypes G1, G2, G3, G4, and G9.
With regard to adverse events, there was no distinction between the two groups (P greater than .15). According to medical investigators, the most common cause of deaths – 27 and 22 in the vaccine and placebo groups, respectively – was infections and infestations (in 37 infants) and metabolism and nutrition disorders (in 6).
Part of what makes this vaccine unique is its shelf life of 2 years when kept at 37° C, or 6 months at 40° C, a key point for Ms. Isanaka and her colleagues.
“The global supply of the vaccines is constrained, and unreliable transportation and storage systems make delivery of vaccines that require refrigeration difficult,” Ms. Isanaka and her colleagues reported. “The introduction of BRV-PV may help to minimize the burden on already strained immunization programs.” The vaccine is also “for sale at or below the current price of the two WHO prequalified vaccines that are supported by the Gavi alliance,” making it possibly more financially accessible as well.
While the per-protocol test found efficacy at 67%, the intention-to-treat population reported a higher efficacy of 73%. Ms. Isanaka and her colleagues believe this number “may more closely represent the efficacy under real-world conditions,” due to the more flexible vaccination schedule.
This study was limited by a short time frame, which did not allow researchers to gather genotyping data pertaining to the efficacy against changing serotypes. BRV-PV also was not given consistently with the oral polio vaccine.
The study was supported by Médecins sans Frontières Operational Center in Geneva and the Kavli Foundation. Ms. Isanaka’s institution, Epicentre, receives core funding from Médecins sans Frontières. Ms. McNeal reports grant support from Epicentre for the study, and other support from Merck and GlaxoSmithKline outside the submitted work. None of the other researchers had relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
Key clinical point:
Major finding: Of 3,508 infants studied, 31 cases of severe rotavirus gastroenteritis were found in the vaccine group, and 87 cases in the placebo group, putting efficacy at 67%.
Data source: Double blind, placebo-controlled test of 3,508 Nigerian infants whose symptoms were measured via 20-point Vesikari scoring.
Disclosures: The study was supported by Médecins sans Frontières Operational Center in Geneva and the Kavli Foundation. Ms. Isanaka’s institution, Epicentre, receives core funding from Médecins sans Frontières. Ms. McNeal reports grant support from Epicentre for the study, and other support from Merck and GlaxoSmithKline outside the submitted work. None of the other researchers had relevant financial disclosures.
Robot-assisted surgery can be a pain
It’s early days for research on the physical impact of robot-assisted surgery on operators. But a study of surgeons who regularly do this kind of work suggests that surgical robots can be the cause of workplace injuries, despite their reputation for good ergonomic design and low stress on surgeon hands, wrists, backs, and necks
More than half (236) of 432 surveyed surgeons with at least 10 robotic surgeries annually reported physical discomfort associated with robotics consoles, according to a study out of Johns Hopkins University, Baltimore.
Most participants were male (71%) and averaged 48 years of age; their specialties comprised gynecology (68%), urology (20%), general surgery (8%), and others (3%).
Of the 432 participants, they reported physical discomfort in the following areas: fingers, 78%; necks, 74%; upper backs, 53%; and 43%, 34%, and 33% in the lower backs, eyes, and wrists, respectively.
Most of those who responded to the survey (80.8%) performed surgery with the da Vinci Si as their primary robotic system, with the rest using a different iteration of the da Vinci system.
Dr. Lee and his colleagues estimate the high rates of reported discomfort in fingers and necks are because of the structure of the robotics console.
“Due to the absence of tactile feedback at the master controller of the surgeon console, some robotic surgeons might close their fingers excessively when holding objects with instruments,” researchers said. “During the performance of suturing and knot-tying tasks, surgeons must squeeze their grip to hold a needle in place because there is no locking mechanism, which is present with open and laparoscopic needle holders.”
Researchers credit high rates of neck pain to the console as well, which “requires [surgeons] to maintain their neck position in a fixed place for extended period of time.”
While the rate of physical discomfort was 56%, participants rated the ergonomic functions of the console an average of 4 out of 5, with 5 being the highest score.
In contrast, surgeons gave low ratings to the communications systems used by the surgeon and the in-room supporting OR staff – an average of 2.87 out of 5 – noting an urgency for system updates.
Overall, researchers found that surgeons with high confidence in their ergonomic console settings were more likely to feel confident in the use of robotics in their surgical procedures and less likely to report physical discomfort. This finding led researchers to conclude the importance of surgeons new to robot-assisted surgery to receive education in ergonomic settings.
“Formal robotic surgery training programs should include this crucially important knowledge about optimal ergonomic guidelines so that any surgeon starting their training in robotic surgery would have the knowledge to maintain sound body posture and to minimize any physical strains while acquiring the best skill set,” according to Dr. Lee and his associates.
This study was limited by the self-reported data, which could create possible reporting bias, as well as by a small sample size. Since surgeons conducted more than one type of surgery annually, researchers found it difficult to identify what had caused the physical symptoms with complete confidence.
Researchers declared no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
It’s early days for research on the physical impact of robot-assisted surgery on operators. But a study of surgeons who regularly do this kind of work suggests that surgical robots can be the cause of workplace injuries, despite their reputation for good ergonomic design and low stress on surgeon hands, wrists, backs, and necks
More than half (236) of 432 surveyed surgeons with at least 10 robotic surgeries annually reported physical discomfort associated with robotics consoles, according to a study out of Johns Hopkins University, Baltimore.
Most participants were male (71%) and averaged 48 years of age; their specialties comprised gynecology (68%), urology (20%), general surgery (8%), and others (3%).
Of the 432 participants, they reported physical discomfort in the following areas: fingers, 78%; necks, 74%; upper backs, 53%; and 43%, 34%, and 33% in the lower backs, eyes, and wrists, respectively.
Most of those who responded to the survey (80.8%) performed surgery with the da Vinci Si as their primary robotic system, with the rest using a different iteration of the da Vinci system.
Dr. Lee and his colleagues estimate the high rates of reported discomfort in fingers and necks are because of the structure of the robotics console.
“Due to the absence of tactile feedback at the master controller of the surgeon console, some robotic surgeons might close their fingers excessively when holding objects with instruments,” researchers said. “During the performance of suturing and knot-tying tasks, surgeons must squeeze their grip to hold a needle in place because there is no locking mechanism, which is present with open and laparoscopic needle holders.”
Researchers credit high rates of neck pain to the console as well, which “requires [surgeons] to maintain their neck position in a fixed place for extended period of time.”
While the rate of physical discomfort was 56%, participants rated the ergonomic functions of the console an average of 4 out of 5, with 5 being the highest score.
In contrast, surgeons gave low ratings to the communications systems used by the surgeon and the in-room supporting OR staff – an average of 2.87 out of 5 – noting an urgency for system updates.
Overall, researchers found that surgeons with high confidence in their ergonomic console settings were more likely to feel confident in the use of robotics in their surgical procedures and less likely to report physical discomfort. This finding led researchers to conclude the importance of surgeons new to robot-assisted surgery to receive education in ergonomic settings.
“Formal robotic surgery training programs should include this crucially important knowledge about optimal ergonomic guidelines so that any surgeon starting their training in robotic surgery would have the knowledge to maintain sound body posture and to minimize any physical strains while acquiring the best skill set,” according to Dr. Lee and his associates.
This study was limited by the self-reported data, which could create possible reporting bias, as well as by a small sample size. Since surgeons conducted more than one type of surgery annually, researchers found it difficult to identify what had caused the physical symptoms with complete confidence.
Researchers declared no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
It’s early days for research on the physical impact of robot-assisted surgery on operators. But a study of surgeons who regularly do this kind of work suggests that surgical robots can be the cause of workplace injuries, despite their reputation for good ergonomic design and low stress on surgeon hands, wrists, backs, and necks
More than half (236) of 432 surveyed surgeons with at least 10 robotic surgeries annually reported physical discomfort associated with robotics consoles, according to a study out of Johns Hopkins University, Baltimore.
Most participants were male (71%) and averaged 48 years of age; their specialties comprised gynecology (68%), urology (20%), general surgery (8%), and others (3%).
Of the 432 participants, they reported physical discomfort in the following areas: fingers, 78%; necks, 74%; upper backs, 53%; and 43%, 34%, and 33% in the lower backs, eyes, and wrists, respectively.
Most of those who responded to the survey (80.8%) performed surgery with the da Vinci Si as their primary robotic system, with the rest using a different iteration of the da Vinci system.
Dr. Lee and his colleagues estimate the high rates of reported discomfort in fingers and necks are because of the structure of the robotics console.
“Due to the absence of tactile feedback at the master controller of the surgeon console, some robotic surgeons might close their fingers excessively when holding objects with instruments,” researchers said. “During the performance of suturing and knot-tying tasks, surgeons must squeeze their grip to hold a needle in place because there is no locking mechanism, which is present with open and laparoscopic needle holders.”
Researchers credit high rates of neck pain to the console as well, which “requires [surgeons] to maintain their neck position in a fixed place for extended period of time.”
While the rate of physical discomfort was 56%, participants rated the ergonomic functions of the console an average of 4 out of 5, with 5 being the highest score.
In contrast, surgeons gave low ratings to the communications systems used by the surgeon and the in-room supporting OR staff – an average of 2.87 out of 5 – noting an urgency for system updates.
Overall, researchers found that surgeons with high confidence in their ergonomic console settings were more likely to feel confident in the use of robotics in their surgical procedures and less likely to report physical discomfort. This finding led researchers to conclude the importance of surgeons new to robot-assisted surgery to receive education in ergonomic settings.
“Formal robotic surgery training programs should include this crucially important knowledge about optimal ergonomic guidelines so that any surgeon starting their training in robotic surgery would have the knowledge to maintain sound body posture and to minimize any physical strains while acquiring the best skill set,” according to Dr. Lee and his associates.
This study was limited by the self-reported data, which could create possible reporting bias, as well as by a small sample size. Since surgeons conducted more than one type of surgery annually, researchers found it difficult to identify what had caused the physical symptoms with complete confidence.
Researchers declared no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
Key clinical point:
Major finding: Of 432 participating surgeons, 236 (56.1%) reported having physical discomfort during or after using the surgical robot.
Data source: A 20-question, self-reporting survey disseminated to surgeons via email, analyzed using logistic regression.
Disclosures: Researchers declared no relevant financial disclosures.
ACP: Substance use disorder is a chronic medical condition
Substance use disorder should be approached as a chronic medical condition, with treatment programs in place of incarceration and improved training programs with which physicians can treat patients with substance abuse.
Such programs are among the eight major recommendations the American College of Physicians has made to improve the nation’s approach to preventing and treating substance abuse in a position paper released March 27 (Ann Intern Med. 2017. doi: 10.7326/M16-2953).
The ACP’s recommendations address the growing rates of opioid addiction, as well as the financial burden of substance abuse on the medical system.
“In 2014, 22.5 million people in the United States needed treatment for an illicit drug or alcohol use problem, but only 18% received any treatment,” according to the paper’s authors. “The medical complications of untreated substance use disorder also drive up health care system costs. Hospitalizations for opioid use disorder rose from nearly 302,000 to more than 520,000 from 2002 to 2012, and costs for such care quadrupled to $15 billion in 2012.”
The complete list of the ACP’s recommendations are:
1) Substance abuse should be approached as a chronic medical disorder. Substance abuse can be treated through evidence-based health programs, according to the ACP. Effort should be put into developing research initiatives, as well as combating the social stigmas associated with substance use disorders.
2) The ACP encourages the establishment of substance abuse programs as a replacement for incarceration. Treatment for substance abuse is a time-sensitive matter, which should be given to patients as soon as possible, including those found guilty of the sale or possession of illegal substances.
3) Policy makers should consider reducing the punishments for drug-related crimes committed by nonviolent offenders. Officials should consider decriminalization, legalization, or treatment alternatives for crimes regarding certain drugs based on the potential risk associated with that drug, the accessibility of treatment in criminal facilities, any disproportionate affects on different sections of the population, and the potential decrease in rates of abuses.
4) There should be multiple stakeholders involved in the creation of programs to eliminate substance abuse. Physicians, policymakers, advocacy groups, and health care professionals are encouraged to work together to create strategies to combat and prevent substance abuse, including programs that expand naloxone access for opioid users or the establishment of a national prescription drug monitoring program. Extensive education programs on proper pain reduction methods should also be made available to physicians to help prevent future dependencies.
5) Coverage of substance use and mental disorder treatments should be mandatory for health insurance companies. Evidence-based treatments for mental health conditions and substance abuse, including counseling, medications, legal services, and education, should be covered by patients’ health insurance. The ACP asserts strict oversight would be essential; however, it is also essential that patients receive nonpharmacologic treatments, which are usually not covered by insurance.
6) There should be an increase in professionals trained to treat substance abuse. There are 4,500 health care professionals in the United States who have mental health and/or substance abuse training, according to the Health Resources and Services Administration. This number shows a high demand for those qualified to treat mental health conditions and substance abuse. Efforts should also be focused on creating a more ethnically diverse group among trained professionals to further increase access to these services.
7) Substance abuse treatment methods should be added to professionals’ continuing medical education. In 2000, 17% of primary care physicians felt very prepared to identify illegal drug use, and 30% could identify drug misuse, according to a study conducted by the National Center on Addiction and Substance Abuse. In response, education for physicians “should be rigorously evaluated to ensure effectiveness and continued access to care and should be designed to prevent onerous burdens on patients and physicians,” according to the paper’s authors.
8) Further study should be conducted on effectiveness of substance abuse programs. Current substance abuse intervention methods should be evaluated to see how effective they are. Among those, safe injection sites should especially be encouraged, as these initiatives have proven effective in reducing unsafe needle sharing in Canada, Australia, and Denmark.
The researchers had no relevant financial disclosures.
[email protected] On Twitter @EAZTweets
Substance use disorder should be approached as a chronic medical condition, with treatment programs in place of incarceration and improved training programs with which physicians can treat patients with substance abuse.
Such programs are among the eight major recommendations the American College of Physicians has made to improve the nation’s approach to preventing and treating substance abuse in a position paper released March 27 (Ann Intern Med. 2017. doi: 10.7326/M16-2953).
The ACP’s recommendations address the growing rates of opioid addiction, as well as the financial burden of substance abuse on the medical system.
“In 2014, 22.5 million people in the United States needed treatment for an illicit drug or alcohol use problem, but only 18% received any treatment,” according to the paper’s authors. “The medical complications of untreated substance use disorder also drive up health care system costs. Hospitalizations for opioid use disorder rose from nearly 302,000 to more than 520,000 from 2002 to 2012, and costs for such care quadrupled to $15 billion in 2012.”
The complete list of the ACP’s recommendations are:
1) Substance abuse should be approached as a chronic medical disorder. Substance abuse can be treated through evidence-based health programs, according to the ACP. Effort should be put into developing research initiatives, as well as combating the social stigmas associated with substance use disorders.
2) The ACP encourages the establishment of substance abuse programs as a replacement for incarceration. Treatment for substance abuse is a time-sensitive matter, which should be given to patients as soon as possible, including those found guilty of the sale or possession of illegal substances.
3) Policy makers should consider reducing the punishments for drug-related crimes committed by nonviolent offenders. Officials should consider decriminalization, legalization, or treatment alternatives for crimes regarding certain drugs based on the potential risk associated with that drug, the accessibility of treatment in criminal facilities, any disproportionate affects on different sections of the population, and the potential decrease in rates of abuses.
4) There should be multiple stakeholders involved in the creation of programs to eliminate substance abuse. Physicians, policymakers, advocacy groups, and health care professionals are encouraged to work together to create strategies to combat and prevent substance abuse, including programs that expand naloxone access for opioid users or the establishment of a national prescription drug monitoring program. Extensive education programs on proper pain reduction methods should also be made available to physicians to help prevent future dependencies.
5) Coverage of substance use and mental disorder treatments should be mandatory for health insurance companies. Evidence-based treatments for mental health conditions and substance abuse, including counseling, medications, legal services, and education, should be covered by patients’ health insurance. The ACP asserts strict oversight would be essential; however, it is also essential that patients receive nonpharmacologic treatments, which are usually not covered by insurance.
6) There should be an increase in professionals trained to treat substance abuse. There are 4,500 health care professionals in the United States who have mental health and/or substance abuse training, according to the Health Resources and Services Administration. This number shows a high demand for those qualified to treat mental health conditions and substance abuse. Efforts should also be focused on creating a more ethnically diverse group among trained professionals to further increase access to these services.
7) Substance abuse treatment methods should be added to professionals’ continuing medical education. In 2000, 17% of primary care physicians felt very prepared to identify illegal drug use, and 30% could identify drug misuse, according to a study conducted by the National Center on Addiction and Substance Abuse. In response, education for physicians “should be rigorously evaluated to ensure effectiveness and continued access to care and should be designed to prevent onerous burdens on patients and physicians,” according to the paper’s authors.
8) Further study should be conducted on effectiveness of substance abuse programs. Current substance abuse intervention methods should be evaluated to see how effective they are. Among those, safe injection sites should especially be encouraged, as these initiatives have proven effective in reducing unsafe needle sharing in Canada, Australia, and Denmark.
The researchers had no relevant financial disclosures.
[email protected] On Twitter @EAZTweets
Substance use disorder should be approached as a chronic medical condition, with treatment programs in place of incarceration and improved training programs with which physicians can treat patients with substance abuse.
Such programs are among the eight major recommendations the American College of Physicians has made to improve the nation’s approach to preventing and treating substance abuse in a position paper released March 27 (Ann Intern Med. 2017. doi: 10.7326/M16-2953).
The ACP’s recommendations address the growing rates of opioid addiction, as well as the financial burden of substance abuse on the medical system.
“In 2014, 22.5 million people in the United States needed treatment for an illicit drug or alcohol use problem, but only 18% received any treatment,” according to the paper’s authors. “The medical complications of untreated substance use disorder also drive up health care system costs. Hospitalizations for opioid use disorder rose from nearly 302,000 to more than 520,000 from 2002 to 2012, and costs for such care quadrupled to $15 billion in 2012.”
The complete list of the ACP’s recommendations are:
1) Substance abuse should be approached as a chronic medical disorder. Substance abuse can be treated through evidence-based health programs, according to the ACP. Effort should be put into developing research initiatives, as well as combating the social stigmas associated with substance use disorders.
2) The ACP encourages the establishment of substance abuse programs as a replacement for incarceration. Treatment for substance abuse is a time-sensitive matter, which should be given to patients as soon as possible, including those found guilty of the sale or possession of illegal substances.
3) Policy makers should consider reducing the punishments for drug-related crimes committed by nonviolent offenders. Officials should consider decriminalization, legalization, or treatment alternatives for crimes regarding certain drugs based on the potential risk associated with that drug, the accessibility of treatment in criminal facilities, any disproportionate affects on different sections of the population, and the potential decrease in rates of abuses.
4) There should be multiple stakeholders involved in the creation of programs to eliminate substance abuse. Physicians, policymakers, advocacy groups, and health care professionals are encouraged to work together to create strategies to combat and prevent substance abuse, including programs that expand naloxone access for opioid users or the establishment of a national prescription drug monitoring program. Extensive education programs on proper pain reduction methods should also be made available to physicians to help prevent future dependencies.
5) Coverage of substance use and mental disorder treatments should be mandatory for health insurance companies. Evidence-based treatments for mental health conditions and substance abuse, including counseling, medications, legal services, and education, should be covered by patients’ health insurance. The ACP asserts strict oversight would be essential; however, it is also essential that patients receive nonpharmacologic treatments, which are usually not covered by insurance.
6) There should be an increase in professionals trained to treat substance abuse. There are 4,500 health care professionals in the United States who have mental health and/or substance abuse training, according to the Health Resources and Services Administration. This number shows a high demand for those qualified to treat mental health conditions and substance abuse. Efforts should also be focused on creating a more ethnically diverse group among trained professionals to further increase access to these services.
7) Substance abuse treatment methods should be added to professionals’ continuing medical education. In 2000, 17% of primary care physicians felt very prepared to identify illegal drug use, and 30% could identify drug misuse, according to a study conducted by the National Center on Addiction and Substance Abuse. In response, education for physicians “should be rigorously evaluated to ensure effectiveness and continued access to care and should be designed to prevent onerous burdens on patients and physicians,” according to the paper’s authors.
8) Further study should be conducted on effectiveness of substance abuse programs. Current substance abuse intervention methods should be evaluated to see how effective they are. Among those, safe injection sites should especially be encouraged, as these initiatives have proven effective in reducing unsafe needle sharing in Canada, Australia, and Denmark.
The researchers had no relevant financial disclosures.
[email protected] On Twitter @EAZTweets
New self-persuasion app to promote HPV vaccine appears effective
A new tablet application using a self-persuasion method has been successful in convincing parents in underserved communities to have their children vaccinated for human papillomavirus (HPV), according to a study.
Of 45 participating parents, 27 of the 33 (82%) parents whose adolescents were not vaccinated reported that they decided to get their children vaccinated after completing the application. The remaining 12 already had an HPV-vaccinated adolescent. Children of participating parents were aged 11-17 years (Patient Educ Couns. 2016. doi: 10.1016/j.pec.2016.11.014).
Of the 45 parents, 31 (69%) were Hispanic and 29 (64%) held a high school education or less, according to the study.
To test the effectiveness of self-persuasion, researchers developed a tablet application which started with a 5 minute video on HPV and vaccine efficacy, and then asked parents to complete two tasks: answer questions about the HPV vaccine that prompt thought on its benefits and come up with personal reasons for why having their child vaccinated is important.
Parents then participated in a 45-60 minute interview with one of six research assistants, who prompted participants to address four research points: Did they like the application? Which questions generated interest in the HPV vaccine without raising concerns? Were they able to communicate reasons for vaccination? Were they convinced to have their children vaccinated?
After watching the video, 18 (55%) of the 33 parents whose children were not vaccinated changed their minds, and, after participating in the self-persuasion questionnaire, an additional 9 parents decided to vaccinate their children, according to the study. Five parents remained undecided, and one decided against HPV vaccination.
Overall, participants reported that the application questions were helpful in their decision to vaccinate their children, with question ratings ranging from 4.33 to 4.98 on a scale of 1 to 5.
Mr. Baldwin and his colleagues said that, while the initial test showed promise, further research must be done on actual vaccine behavior, as these tests only studied verbally reported decisions by parents.
One of the limitations to the study was that the research was primarily conducted at a research facility. While some was conducted in local clinics, Mr. Baldwin and his colleagues consider that further studies should be conducted in more public areas. All but one of the participants were female, which may make it hard to generalize about the effects of this application with male parents.
The researchers reported no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
The media has not been kind when it comes to HPV vaccinations. When most parents are approached with the option to have their children vaccinated, they are hesitant because of what they have heard from television, news articles, or online mom chat rooms about the dangerous side effects of the vaccine. When a mother hears about other mothers’ daughters fainting or being subjected to pain, she usually wonders if it is really worth the risk.
The same goes for parents who expect their daughters to practice celibacy until marriage. After all, why expose a child to negative side effects when she won’t be having sex anyway? The problem with this thinking, however, is that, often, it is not based in reality. When I approach families about HPV vaccine, or any other vaccine for that matter, I make sure to present studies that explain the lack of evidence on negative vaccine side effects, as well as information pertaining to how common HPV is.
However, simply handing out a fact sheet is not enough. Parents who are convinced that their children do not need to be vaccinated will not be persuaded through statistics but through personal anecdotes. I like to tell mothers to ask their girlfriends about being vaccinated, to not only see how common HPV is but to break the stigma as well. I explain to parents who do not want their child having sex now that, at some point, they might want their child to grow their family, and, when that time comes, don’t they want their child to be safe? Even if it is just one time, shouldn’t their child be protected? From that point on, the language of conversation has changed, and the channels of communication are more open.
As pediatricians, we are the medical advocates for our patients and their families, not just someone to prescribe medication for them. Establish that role through knowledge and conversation, and persuasion will soon follow.
Francine Pearce, MD, is a pediatrician in Frankfort, Ill. She writes the Pediatric News teen column, Pearce-ings .
The media has not been kind when it comes to HPV vaccinations. When most parents are approached with the option to have their children vaccinated, they are hesitant because of what they have heard from television, news articles, or online mom chat rooms about the dangerous side effects of the vaccine. When a mother hears about other mothers’ daughters fainting or being subjected to pain, she usually wonders if it is really worth the risk.
The same goes for parents who expect their daughters to practice celibacy until marriage. After all, why expose a child to negative side effects when she won’t be having sex anyway? The problem with this thinking, however, is that, often, it is not based in reality. When I approach families about HPV vaccine, or any other vaccine for that matter, I make sure to present studies that explain the lack of evidence on negative vaccine side effects, as well as information pertaining to how common HPV is.
However, simply handing out a fact sheet is not enough. Parents who are convinced that their children do not need to be vaccinated will not be persuaded through statistics but through personal anecdotes. I like to tell mothers to ask their girlfriends about being vaccinated, to not only see how common HPV is but to break the stigma as well. I explain to parents who do not want their child having sex now that, at some point, they might want their child to grow their family, and, when that time comes, don’t they want their child to be safe? Even if it is just one time, shouldn’t their child be protected? From that point on, the language of conversation has changed, and the channels of communication are more open.
As pediatricians, we are the medical advocates for our patients and their families, not just someone to prescribe medication for them. Establish that role through knowledge and conversation, and persuasion will soon follow.
Francine Pearce, MD, is a pediatrician in Frankfort, Ill. She writes the Pediatric News teen column, Pearce-ings .
The media has not been kind when it comes to HPV vaccinations. When most parents are approached with the option to have their children vaccinated, they are hesitant because of what they have heard from television, news articles, or online mom chat rooms about the dangerous side effects of the vaccine. When a mother hears about other mothers’ daughters fainting or being subjected to pain, she usually wonders if it is really worth the risk.
The same goes for parents who expect their daughters to practice celibacy until marriage. After all, why expose a child to negative side effects when she won’t be having sex anyway? The problem with this thinking, however, is that, often, it is not based in reality. When I approach families about HPV vaccine, or any other vaccine for that matter, I make sure to present studies that explain the lack of evidence on negative vaccine side effects, as well as information pertaining to how common HPV is.
However, simply handing out a fact sheet is not enough. Parents who are convinced that their children do not need to be vaccinated will not be persuaded through statistics but through personal anecdotes. I like to tell mothers to ask their girlfriends about being vaccinated, to not only see how common HPV is but to break the stigma as well. I explain to parents who do not want their child having sex now that, at some point, they might want their child to grow their family, and, when that time comes, don’t they want their child to be safe? Even if it is just one time, shouldn’t their child be protected? From that point on, the language of conversation has changed, and the channels of communication are more open.
As pediatricians, we are the medical advocates for our patients and their families, not just someone to prescribe medication for them. Establish that role through knowledge and conversation, and persuasion will soon follow.
Francine Pearce, MD, is a pediatrician in Frankfort, Ill. She writes the Pediatric News teen column, Pearce-ings .
A new tablet application using a self-persuasion method has been successful in convincing parents in underserved communities to have their children vaccinated for human papillomavirus (HPV), according to a study.
Of 45 participating parents, 27 of the 33 (82%) parents whose adolescents were not vaccinated reported that they decided to get their children vaccinated after completing the application. The remaining 12 already had an HPV-vaccinated adolescent. Children of participating parents were aged 11-17 years (Patient Educ Couns. 2016. doi: 10.1016/j.pec.2016.11.014).
Of the 45 parents, 31 (69%) were Hispanic and 29 (64%) held a high school education or less, according to the study.
To test the effectiveness of self-persuasion, researchers developed a tablet application which started with a 5 minute video on HPV and vaccine efficacy, and then asked parents to complete two tasks: answer questions about the HPV vaccine that prompt thought on its benefits and come up with personal reasons for why having their child vaccinated is important.
Parents then participated in a 45-60 minute interview with one of six research assistants, who prompted participants to address four research points: Did they like the application? Which questions generated interest in the HPV vaccine without raising concerns? Were they able to communicate reasons for vaccination? Were they convinced to have their children vaccinated?
After watching the video, 18 (55%) of the 33 parents whose children were not vaccinated changed their minds, and, after participating in the self-persuasion questionnaire, an additional 9 parents decided to vaccinate their children, according to the study. Five parents remained undecided, and one decided against HPV vaccination.
Overall, participants reported that the application questions were helpful in their decision to vaccinate their children, with question ratings ranging from 4.33 to 4.98 on a scale of 1 to 5.
Mr. Baldwin and his colleagues said that, while the initial test showed promise, further research must be done on actual vaccine behavior, as these tests only studied verbally reported decisions by parents.
One of the limitations to the study was that the research was primarily conducted at a research facility. While some was conducted in local clinics, Mr. Baldwin and his colleagues consider that further studies should be conducted in more public areas. All but one of the participants were female, which may make it hard to generalize about the effects of this application with male parents.
The researchers reported no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
A new tablet application using a self-persuasion method has been successful in convincing parents in underserved communities to have their children vaccinated for human papillomavirus (HPV), according to a study.
Of 45 participating parents, 27 of the 33 (82%) parents whose adolescents were not vaccinated reported that they decided to get their children vaccinated after completing the application. The remaining 12 already had an HPV-vaccinated adolescent. Children of participating parents were aged 11-17 years (Patient Educ Couns. 2016. doi: 10.1016/j.pec.2016.11.014).
Of the 45 parents, 31 (69%) were Hispanic and 29 (64%) held a high school education or less, according to the study.
To test the effectiveness of self-persuasion, researchers developed a tablet application which started with a 5 minute video on HPV and vaccine efficacy, and then asked parents to complete two tasks: answer questions about the HPV vaccine that prompt thought on its benefits and come up with personal reasons for why having their child vaccinated is important.
Parents then participated in a 45-60 minute interview with one of six research assistants, who prompted participants to address four research points: Did they like the application? Which questions generated interest in the HPV vaccine without raising concerns? Were they able to communicate reasons for vaccination? Were they convinced to have their children vaccinated?
After watching the video, 18 (55%) of the 33 parents whose children were not vaccinated changed their minds, and, after participating in the self-persuasion questionnaire, an additional 9 parents decided to vaccinate their children, according to the study. Five parents remained undecided, and one decided against HPV vaccination.
Overall, participants reported that the application questions were helpful in their decision to vaccinate their children, with question ratings ranging from 4.33 to 4.98 on a scale of 1 to 5.
Mr. Baldwin and his colleagues said that, while the initial test showed promise, further research must be done on actual vaccine behavior, as these tests only studied verbally reported decisions by parents.
One of the limitations to the study was that the research was primarily conducted at a research facility. While some was conducted in local clinics, Mr. Baldwin and his colleagues consider that further studies should be conducted in more public areas. All but one of the participants were female, which may make it hard to generalize about the effects of this application with male parents.
The researchers reported no relevant financial disclosures.
[email protected]
On Twitter @EAZTweets
FROM PATIENT EDUCATION & COUNSELING
Key clinical point:
Major finding: Of the 33 parents whose children were not vaccinated, 27 (818%) decided to have their children vaccinated after using the application.
Data source: A study of 45 parents in low-income communities, evaluated through self-reporting questionnaires and in-person interviews conducted by research assistants.
Disclosures: Researchers reported no relevant financial disclosures.