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Lasers and topicals both lighten solar lentigines
Quality-switched (QS) laser therapy with a ruby laser and topical triple-combination therapy (TCT) were similarly effective in lightening solar lentigines, based on data from a prospective, open label study of 15 adults. The findings were published in Dermatologic Surgery.
The QS ruby laser (QSRL) delivered longer-lasting skin-lightening results in less time, but the topical therapy is less expensive and has a lower risk of adverse events, wrote Dr. Laurence Imhof of the department of dermatology, University Hospital Zürich, and colleagues (Dermatol Surg. 2016;42:853-57. doi: 10.1097/DSS.0000000000000793). “Although therapy [for solar lentigines] is not medically indicated, there is a rising treatment demand for aesthetic reasons. Therefore, the treatment should be very safe and affordable,” they wrote.
The researchers compared the safety and efficacy of treating solar lentigines with a 694-nm QSRL and TCT (hydroquinone 5%, tretinoin 0.03%, and dexamethasone 0.03%). The patients included 14 women and 1 man with evenly distributed solar lentigines on the backs of both hands. Each patient was treated with 1-2 QSRL sessions on the back of the right hand and 7 weeks of once-daily application of TCT on the back of the left hand. The average age of the patients was 61 years; 13 were Fitzpatrick Skin Types II and III. Adverse events were mild and transient with both treatments, although the QSRL caused significantly more crusting and hyperpigmentation than the TCT.
Both treatments significantly reduced pigment at the end of treatment (day 56) and 12 weeks’ post treatment (140 days), compared with baseline. Treatment areas were evaluated at days 28, 56, and 140 by the treating physician, the patient, and a blinded physician (based on photos).The 6-point grading scale rated the degree of lightening/percentage of clearing, ranging from worse (less than 0%) to excellent (76%-100%).
At 56 days, the mean macroscopic improvement with QSRL laser was rated 3.5 by the treating physician and patient and 3 by a blinded physician; the mean macroscopic improvement with TCT was rated 2.4 by the treating physician, 2.2 by the patient, and 1.7 by the blinded physician. At 140 days, the mean macroscopic improvements with the laser were rated 2.9 by the treating physician, 2.7 by the patient, and 2.8 by the blinded physician, compared with 1.2, 1.1, and 0.7, respectively, with TCT.
The results were limited by the small size, short follow-up period, and open-label design, the researchers noted. However, the study is the first known to compare a laser and a topical treatment for the management of solar lentigines, and the findings suggest that both therapies can be recommended for the aesthetic treatment of solar lentigines, they said.
The TCT cream used in the study was provided by Louis Widmer SA, which provided a grant to the University of Zürich. The researchers had no financial conflicts to disclose.
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Dr. Nazanin Saedi |
“We commend Imhof and colleagues for providing a long-awaited direct comparison of the Q-switched laser and topical triple-combination therapy,” wrote Dr. Laura M. Schilling and Dr. Nazanin Saedi, in an accompanying editorial (Dermatol Surg. 2016;42:8580859. doi: 10.1097/DSS.0000000000000792). Both treatments are viable options for patients, they emphasized. “It is fundamental, especially in this era of patient-centered care, to recognize that treatment options must be individualized. There are numerous variables to be considered when choosing the appropriate treatment for a patient including efficacy, skin type, cost, availability, and patient preference, among others.”
Dr. Schilling and Dr. Saedi are with the department of dermatology and cutaneous biology, Thomas Jefferson University, Philadelphia. They had no financial conflicts to disclose.
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Dr. Nazanin Saedi |
“We commend Imhof and colleagues for providing a long-awaited direct comparison of the Q-switched laser and topical triple-combination therapy,” wrote Dr. Laura M. Schilling and Dr. Nazanin Saedi, in an accompanying editorial (Dermatol Surg. 2016;42:8580859. doi: 10.1097/DSS.0000000000000792). Both treatments are viable options for patients, they emphasized. “It is fundamental, especially in this era of patient-centered care, to recognize that treatment options must be individualized. There are numerous variables to be considered when choosing the appropriate treatment for a patient including efficacy, skin type, cost, availability, and patient preference, among others.”
Dr. Schilling and Dr. Saedi are with the department of dermatology and cutaneous biology, Thomas Jefferson University, Philadelphia. They had no financial conflicts to disclose.
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|
Dr. Nazanin Saedi |
“We commend Imhof and colleagues for providing a long-awaited direct comparison of the Q-switched laser and topical triple-combination therapy,” wrote Dr. Laura M. Schilling and Dr. Nazanin Saedi, in an accompanying editorial (Dermatol Surg. 2016;42:8580859. doi: 10.1097/DSS.0000000000000792). Both treatments are viable options for patients, they emphasized. “It is fundamental, especially in this era of patient-centered care, to recognize that treatment options must be individualized. There are numerous variables to be considered when choosing the appropriate treatment for a patient including efficacy, skin type, cost, availability, and patient preference, among others.”
Dr. Schilling and Dr. Saedi are with the department of dermatology and cutaneous biology, Thomas Jefferson University, Philadelphia. They had no financial conflicts to disclose.
Quality-switched (QS) laser therapy with a ruby laser and topical triple-combination therapy (TCT) were similarly effective in lightening solar lentigines, based on data from a prospective, open label study of 15 adults. The findings were published in Dermatologic Surgery.
The QS ruby laser (QSRL) delivered longer-lasting skin-lightening results in less time, but the topical therapy is less expensive and has a lower risk of adverse events, wrote Dr. Laurence Imhof of the department of dermatology, University Hospital Zürich, and colleagues (Dermatol Surg. 2016;42:853-57. doi: 10.1097/DSS.0000000000000793). “Although therapy [for solar lentigines] is not medically indicated, there is a rising treatment demand for aesthetic reasons. Therefore, the treatment should be very safe and affordable,” they wrote.
The researchers compared the safety and efficacy of treating solar lentigines with a 694-nm QSRL and TCT (hydroquinone 5%, tretinoin 0.03%, and dexamethasone 0.03%). The patients included 14 women and 1 man with evenly distributed solar lentigines on the backs of both hands. Each patient was treated with 1-2 QSRL sessions on the back of the right hand and 7 weeks of once-daily application of TCT on the back of the left hand. The average age of the patients was 61 years; 13 were Fitzpatrick Skin Types II and III. Adverse events were mild and transient with both treatments, although the QSRL caused significantly more crusting and hyperpigmentation than the TCT.
Both treatments significantly reduced pigment at the end of treatment (day 56) and 12 weeks’ post treatment (140 days), compared with baseline. Treatment areas were evaluated at days 28, 56, and 140 by the treating physician, the patient, and a blinded physician (based on photos).The 6-point grading scale rated the degree of lightening/percentage of clearing, ranging from worse (less than 0%) to excellent (76%-100%).
At 56 days, the mean macroscopic improvement with QSRL laser was rated 3.5 by the treating physician and patient and 3 by a blinded physician; the mean macroscopic improvement with TCT was rated 2.4 by the treating physician, 2.2 by the patient, and 1.7 by the blinded physician. At 140 days, the mean macroscopic improvements with the laser were rated 2.9 by the treating physician, 2.7 by the patient, and 2.8 by the blinded physician, compared with 1.2, 1.1, and 0.7, respectively, with TCT.
The results were limited by the small size, short follow-up period, and open-label design, the researchers noted. However, the study is the first known to compare a laser and a topical treatment for the management of solar lentigines, and the findings suggest that both therapies can be recommended for the aesthetic treatment of solar lentigines, they said.
The TCT cream used in the study was provided by Louis Widmer SA, which provided a grant to the University of Zürich. The researchers had no financial conflicts to disclose.
Quality-switched (QS) laser therapy with a ruby laser and topical triple-combination therapy (TCT) were similarly effective in lightening solar lentigines, based on data from a prospective, open label study of 15 adults. The findings were published in Dermatologic Surgery.
The QS ruby laser (QSRL) delivered longer-lasting skin-lightening results in less time, but the topical therapy is less expensive and has a lower risk of adverse events, wrote Dr. Laurence Imhof of the department of dermatology, University Hospital Zürich, and colleagues (Dermatol Surg. 2016;42:853-57. doi: 10.1097/DSS.0000000000000793). “Although therapy [for solar lentigines] is not medically indicated, there is a rising treatment demand for aesthetic reasons. Therefore, the treatment should be very safe and affordable,” they wrote.
The researchers compared the safety and efficacy of treating solar lentigines with a 694-nm QSRL and TCT (hydroquinone 5%, tretinoin 0.03%, and dexamethasone 0.03%). The patients included 14 women and 1 man with evenly distributed solar lentigines on the backs of both hands. Each patient was treated with 1-2 QSRL sessions on the back of the right hand and 7 weeks of once-daily application of TCT on the back of the left hand. The average age of the patients was 61 years; 13 were Fitzpatrick Skin Types II and III. Adverse events were mild and transient with both treatments, although the QSRL caused significantly more crusting and hyperpigmentation than the TCT.
Both treatments significantly reduced pigment at the end of treatment (day 56) and 12 weeks’ post treatment (140 days), compared with baseline. Treatment areas were evaluated at days 28, 56, and 140 by the treating physician, the patient, and a blinded physician (based on photos).The 6-point grading scale rated the degree of lightening/percentage of clearing, ranging from worse (less than 0%) to excellent (76%-100%).
At 56 days, the mean macroscopic improvement with QSRL laser was rated 3.5 by the treating physician and patient and 3 by a blinded physician; the mean macroscopic improvement with TCT was rated 2.4 by the treating physician, 2.2 by the patient, and 1.7 by the blinded physician. At 140 days, the mean macroscopic improvements with the laser were rated 2.9 by the treating physician, 2.7 by the patient, and 2.8 by the blinded physician, compared with 1.2, 1.1, and 0.7, respectively, with TCT.
The results were limited by the small size, short follow-up period, and open-label design, the researchers noted. However, the study is the first known to compare a laser and a topical treatment for the management of solar lentigines, and the findings suggest that both therapies can be recommended for the aesthetic treatment of solar lentigines, they said.
The TCT cream used in the study was provided by Louis Widmer SA, which provided a grant to the University of Zürich. The researchers had no financial conflicts to disclose.
FROM DERMATOLOGIC SURGERY
Key clinical point: Both treatments significantly reduced pigment at the study conclusion (day 56) and at 12 weeks post treatment, compared with baseline.
Major finding: The mean macroscopic improvement with QSRL laser at 56 days was rated 3.5 by the treating physician and patient and 3 by a blinded physician; the mean macroscopic improvement with TCT was rated 2.4 by the treating physician, 2.2 by the patient, and 1.7 by the blinded physician.
Data source: A prospective, open-label 20-week study of 15 patients with solar lentigines.
Disclosures: The TCT cream used in the study was provided by Louis Widmer SA, which provided a grant to the University of Zürich. The researchers had no financial conflicts to disclose.
Don’t underestimate opioid use in HIV-positive adults
Prescription opioid use in HIV-positive individuals is underestimated, based on data from a 12-week study of medical and nonmedical prescription drug use in HIV patients attending a medical center and community clinic.
Of the 254 participants in the study, 43% reported medical use of prescription opioids, and 11% of the opioid use was reported as nonmedical.
Previous studies of prescription drug use in the HIV-positive population have mainly focused on nonmedical use, so “the existing research likely underestimates overall exposure of HIV-positive individuals to prescription medications,” wrote Abigail Norris Turner, PhD, of Ohio State University in Columbus, and her colleagues. Nonmedical use was defined as “using more medication than prescribed, using medication prescribed to someone else, or using medication for a purpose other than its prescribed use,” the researchers wrote.
The cross-sectional, self-administered survey involved data collection during July and August 2015 at a large, urban medical center (149 patients) and a community-based AIDS service organization (105 patients). Most of the study participants were male (91%), were identified as gay or bisexual (79%), and were at least 40 years old (61%).
Overall, 27% of the participants reported nonmedical use of any prescription drug during the previous year. Of these, 17% reported using one medication, 8% reported using two medications, and 2% reported using three or more medications. During the past month, 14% reported nonmedical use of a prescription drug, with 17% reporting one medication, 8% reporting two medications, and 2% reporting three or more medications. Reports of drug use were similar between the hospital group and clinic group.
The findings were limited by the cross-sectional nature of the study and the reliance on self-reports, the researchers noted; therefore, “we cannot make inferences about the causes and consequences of prescription medication use,” they said.
However, the results suggest that “it would be prudent for HIV providers to regularly review their opioid prescription practices to make sure they are appropriate; this review could also help identify patients at risk for opioid dependence and those who may benefit from referral to a pain medicine specialist or addiction medicine specialist,” they wrote.
The study was supported in part by the National Institutes of Health and the SOLAR Foundation Research Fund at the Ohio State University.
Read the full study here: AIDS Care 2016 Jun 20. doi: 10.1080/09540121.2016.1198746.
Prescription opioid use in HIV-positive individuals is underestimated, based on data from a 12-week study of medical and nonmedical prescription drug use in HIV patients attending a medical center and community clinic.
Of the 254 participants in the study, 43% reported medical use of prescription opioids, and 11% of the opioid use was reported as nonmedical.
Previous studies of prescription drug use in the HIV-positive population have mainly focused on nonmedical use, so “the existing research likely underestimates overall exposure of HIV-positive individuals to prescription medications,” wrote Abigail Norris Turner, PhD, of Ohio State University in Columbus, and her colleagues. Nonmedical use was defined as “using more medication than prescribed, using medication prescribed to someone else, or using medication for a purpose other than its prescribed use,” the researchers wrote.
The cross-sectional, self-administered survey involved data collection during July and August 2015 at a large, urban medical center (149 patients) and a community-based AIDS service organization (105 patients). Most of the study participants were male (91%), were identified as gay or bisexual (79%), and were at least 40 years old (61%).
Overall, 27% of the participants reported nonmedical use of any prescription drug during the previous year. Of these, 17% reported using one medication, 8% reported using two medications, and 2% reported using three or more medications. During the past month, 14% reported nonmedical use of a prescription drug, with 17% reporting one medication, 8% reporting two medications, and 2% reporting three or more medications. Reports of drug use were similar between the hospital group and clinic group.
The findings were limited by the cross-sectional nature of the study and the reliance on self-reports, the researchers noted; therefore, “we cannot make inferences about the causes and consequences of prescription medication use,” they said.
However, the results suggest that “it would be prudent for HIV providers to regularly review their opioid prescription practices to make sure they are appropriate; this review could also help identify patients at risk for opioid dependence and those who may benefit from referral to a pain medicine specialist or addiction medicine specialist,” they wrote.
The study was supported in part by the National Institutes of Health and the SOLAR Foundation Research Fund at the Ohio State University.
Read the full study here: AIDS Care 2016 Jun 20. doi: 10.1080/09540121.2016.1198746.
Prescription opioid use in HIV-positive individuals is underestimated, based on data from a 12-week study of medical and nonmedical prescription drug use in HIV patients attending a medical center and community clinic.
Of the 254 participants in the study, 43% reported medical use of prescription opioids, and 11% of the opioid use was reported as nonmedical.
Previous studies of prescription drug use in the HIV-positive population have mainly focused on nonmedical use, so “the existing research likely underestimates overall exposure of HIV-positive individuals to prescription medications,” wrote Abigail Norris Turner, PhD, of Ohio State University in Columbus, and her colleagues. Nonmedical use was defined as “using more medication than prescribed, using medication prescribed to someone else, or using medication for a purpose other than its prescribed use,” the researchers wrote.
The cross-sectional, self-administered survey involved data collection during July and August 2015 at a large, urban medical center (149 patients) and a community-based AIDS service organization (105 patients). Most of the study participants were male (91%), were identified as gay or bisexual (79%), and were at least 40 years old (61%).
Overall, 27% of the participants reported nonmedical use of any prescription drug during the previous year. Of these, 17% reported using one medication, 8% reported using two medications, and 2% reported using three or more medications. During the past month, 14% reported nonmedical use of a prescription drug, with 17% reporting one medication, 8% reporting two medications, and 2% reporting three or more medications. Reports of drug use were similar between the hospital group and clinic group.
The findings were limited by the cross-sectional nature of the study and the reliance on self-reports, the researchers noted; therefore, “we cannot make inferences about the causes and consequences of prescription medication use,” they said.
However, the results suggest that “it would be prudent for HIV providers to regularly review their opioid prescription practices to make sure they are appropriate; this review could also help identify patients at risk for opioid dependence and those who may benefit from referral to a pain medicine specialist or addiction medicine specialist,” they wrote.
The study was supported in part by the National Institutes of Health and the SOLAR Foundation Research Fund at the Ohio State University.
Read the full study here: AIDS Care 2016 Jun 20. doi: 10.1080/09540121.2016.1198746.
FROM AIDS CARE
Key clinical point: Opioid exposure in HIV-positive adults is more prevalent than previous research suggests.
Major finding: Based on data from 254 individuals, 43% reported medical opioid use, and 11% reported nonmedical opioid use.
Data source: A cross-sectional survey involving 254 HIV-positive adults at two study sites.
Disclosures: The study was supported in part by the National Institutes of Health and the SOLAR Foundation Research Fund at the Ohio State University.
Vasodilator, biomarkers present potential for preeclampsia care
Treatment with oral sildenafil citrate significantly extended gestation by 4 days, compared with placebo in women with preeclampsia in a randomized trial.
The findings come from one of a trio of studies looking at efforts to improve outcomes for women with preeclampsia, which were published online July 11 in Obstetrics & Gynecology.
“We hypothesized that the potential increase in in utero placental and fetoplacental blood flow with the use of sildenafil citrate may be associated with pregnancy prolongation (the primary study outcome) and improved maternal and perinatal outcomes,” wrote Alberto Trapani Jr., MD, PhD, of Hospital of Federal University of Santa Catarina, Florianopolis, Brazil, and his colleagues (Obstet Gynecol. 2016;128:253-259. doi: 10.1097/AOG.0000000000001518).
The researchers randomized 93 singleton pregnancies with preeclampsia at 24 to 33 weeks’ gestation to receive 50 mg oral sildenafil citrate (47 patients) or a placebo (46 patients) every 8 hours. Baseline characteristics were similar between the two groups.
Overall, pregnancies lasted an average of another 14.4 days in the sildenafil group, compared with 10.4 days in the placebo group. Additionally, the percent reduction in the pulsality indices of both uterine arteries and umbilical arteries were significantly higher in the sildenafil group, compared with the placebo group (22.5% vs. 2.1% and 18.5% vs. 2.5%, respectively). Maternal blood pressure before and 24 hours after randomization was lower with sildenafil. Incidence of adverse effects, perinatal morbidity, and mortality were similar between the two groups.
“These results, combined with the results of other studies, are promising,” although larger studies with earlier treatment initiation are needed, the researchers wrote. Evaluation of other phosphodiesterase type 5 inhibitors also may be useful in treating preeclampsia, they noted. Dr. Trapani and his colleagues reported having no financial conflicts.
Two other studies published in the same issue of Obstetrics & Gynecology focused on using biomarkers to help predict delivery times in women with suspected preeclampsia.
Any one of several single angiogenesis-related biomarkers can be a useful diagnostic test for preeclampsia, wrote Suzy Duckworth, MBBS, of King’s College London and her colleagues. In a prospective, observational study of 423 women with suspected preeclampsia, the researchers found that a combination of biomarkers including placental growth factor (PlGF) was not significantly better than PlGF alone (receiver operating curve area of 0.90 and 0.87, respectively) for predicting preeclampsia requiring delivery within 14 days. Two other single markers, soluble fms-like tyrosine kinase-1 (sFlt-1) and endoglin, yielded similar results; each demonstrated a receiver operating curve area of 0.83.
“It is currently difficult to distinguish preeclampsia of a severity that requires early delivery from other less serious phenotypes,” the researchers wrote. “An accurate biomarker (or panel of biomarkers) to enable prognosis of perinatal complications could have a substantial effect on management strategies, with the aim of minimizing adverse maternal and fetal outcomes,” they wrote (Obstet Gynecol. 2016;128:245-252. doi: 10.1097/AOG.0000000000001508).
Dr. Duckworth had no financial conflicts to disclose, but several of her coauthors disclosed relationships with pharmaceutical companies and one coauthor is a minority shareholder in Metabolomic Diagnostics, a company with an interest in preeclampsia biomarkers.
In another study including 1,041 women with suspected preeclampsia, those with a sFlt-1:PlGF ratio greater than 38 were nearly three times as likely to deliver on the day of the test than women with an sFlt-1:PlGF ratio of 38 or less, wrote Harald Zeisler, MD, of Medical University Vienna and his colleagues (Obstet Gynecol. 2016;128:261-269. doi: 10.1097/AOG.0000000000001525).
Women with an sFlt-1:PlGF ratio greater than 38 also had significantly shorter remaining times to delivery than women with an sFlt-1:PlGF ratio of 38 or less (median 17 days vs. 51 days). The study was a secondary analysis of an observational cohort study of women aged 18 years and older from 24 to 36 6/7 weeks’ gestation.
In a preterm birth analysis of 848 women, 71% of the 184 women with an sFlt-1:PlGF ratio greater than 38 had a preterm delivery, compared with 18% of the 664 women with an sFlt-1:PlGF ratio of 38 or less.
The future clinical use of the sFlt-1:PlGF ratio “may potentially assist in informing the health care team of an impending risk to the mother, fetus, or both that may require further assessment and medical intervention,” the researchers wrote.
Dr. Zeisler and several coauthors disclosed relationships with multiple companies, including Roche Diagnostics, which sponsored the study.
Treatment with oral sildenafil citrate significantly extended gestation by 4 days, compared with placebo in women with preeclampsia in a randomized trial.
The findings come from one of a trio of studies looking at efforts to improve outcomes for women with preeclampsia, which were published online July 11 in Obstetrics & Gynecology.
“We hypothesized that the potential increase in in utero placental and fetoplacental blood flow with the use of sildenafil citrate may be associated with pregnancy prolongation (the primary study outcome) and improved maternal and perinatal outcomes,” wrote Alberto Trapani Jr., MD, PhD, of Hospital of Federal University of Santa Catarina, Florianopolis, Brazil, and his colleagues (Obstet Gynecol. 2016;128:253-259. doi: 10.1097/AOG.0000000000001518).
The researchers randomized 93 singleton pregnancies with preeclampsia at 24 to 33 weeks’ gestation to receive 50 mg oral sildenafil citrate (47 patients) or a placebo (46 patients) every 8 hours. Baseline characteristics were similar between the two groups.
Overall, pregnancies lasted an average of another 14.4 days in the sildenafil group, compared with 10.4 days in the placebo group. Additionally, the percent reduction in the pulsality indices of both uterine arteries and umbilical arteries were significantly higher in the sildenafil group, compared with the placebo group (22.5% vs. 2.1% and 18.5% vs. 2.5%, respectively). Maternal blood pressure before and 24 hours after randomization was lower with sildenafil. Incidence of adverse effects, perinatal morbidity, and mortality were similar between the two groups.
“These results, combined with the results of other studies, are promising,” although larger studies with earlier treatment initiation are needed, the researchers wrote. Evaluation of other phosphodiesterase type 5 inhibitors also may be useful in treating preeclampsia, they noted. Dr. Trapani and his colleagues reported having no financial conflicts.
Two other studies published in the same issue of Obstetrics & Gynecology focused on using biomarkers to help predict delivery times in women with suspected preeclampsia.
Any one of several single angiogenesis-related biomarkers can be a useful diagnostic test for preeclampsia, wrote Suzy Duckworth, MBBS, of King’s College London and her colleagues. In a prospective, observational study of 423 women with suspected preeclampsia, the researchers found that a combination of biomarkers including placental growth factor (PlGF) was not significantly better than PlGF alone (receiver operating curve area of 0.90 and 0.87, respectively) for predicting preeclampsia requiring delivery within 14 days. Two other single markers, soluble fms-like tyrosine kinase-1 (sFlt-1) and endoglin, yielded similar results; each demonstrated a receiver operating curve area of 0.83.
“It is currently difficult to distinguish preeclampsia of a severity that requires early delivery from other less serious phenotypes,” the researchers wrote. “An accurate biomarker (or panel of biomarkers) to enable prognosis of perinatal complications could have a substantial effect on management strategies, with the aim of minimizing adverse maternal and fetal outcomes,” they wrote (Obstet Gynecol. 2016;128:245-252. doi: 10.1097/AOG.0000000000001508).
Dr. Duckworth had no financial conflicts to disclose, but several of her coauthors disclosed relationships with pharmaceutical companies and one coauthor is a minority shareholder in Metabolomic Diagnostics, a company with an interest in preeclampsia biomarkers.
In another study including 1,041 women with suspected preeclampsia, those with a sFlt-1:PlGF ratio greater than 38 were nearly three times as likely to deliver on the day of the test than women with an sFlt-1:PlGF ratio of 38 or less, wrote Harald Zeisler, MD, of Medical University Vienna and his colleagues (Obstet Gynecol. 2016;128:261-269. doi: 10.1097/AOG.0000000000001525).
Women with an sFlt-1:PlGF ratio greater than 38 also had significantly shorter remaining times to delivery than women with an sFlt-1:PlGF ratio of 38 or less (median 17 days vs. 51 days). The study was a secondary analysis of an observational cohort study of women aged 18 years and older from 24 to 36 6/7 weeks’ gestation.
In a preterm birth analysis of 848 women, 71% of the 184 women with an sFlt-1:PlGF ratio greater than 38 had a preterm delivery, compared with 18% of the 664 women with an sFlt-1:PlGF ratio of 38 or less.
The future clinical use of the sFlt-1:PlGF ratio “may potentially assist in informing the health care team of an impending risk to the mother, fetus, or both that may require further assessment and medical intervention,” the researchers wrote.
Dr. Zeisler and several coauthors disclosed relationships with multiple companies, including Roche Diagnostics, which sponsored the study.
Treatment with oral sildenafil citrate significantly extended gestation by 4 days, compared with placebo in women with preeclampsia in a randomized trial.
The findings come from one of a trio of studies looking at efforts to improve outcomes for women with preeclampsia, which were published online July 11 in Obstetrics & Gynecology.
“We hypothesized that the potential increase in in utero placental and fetoplacental blood flow with the use of sildenafil citrate may be associated with pregnancy prolongation (the primary study outcome) and improved maternal and perinatal outcomes,” wrote Alberto Trapani Jr., MD, PhD, of Hospital of Federal University of Santa Catarina, Florianopolis, Brazil, and his colleagues (Obstet Gynecol. 2016;128:253-259. doi: 10.1097/AOG.0000000000001518).
The researchers randomized 93 singleton pregnancies with preeclampsia at 24 to 33 weeks’ gestation to receive 50 mg oral sildenafil citrate (47 patients) or a placebo (46 patients) every 8 hours. Baseline characteristics were similar between the two groups.
Overall, pregnancies lasted an average of another 14.4 days in the sildenafil group, compared with 10.4 days in the placebo group. Additionally, the percent reduction in the pulsality indices of both uterine arteries and umbilical arteries were significantly higher in the sildenafil group, compared with the placebo group (22.5% vs. 2.1% and 18.5% vs. 2.5%, respectively). Maternal blood pressure before and 24 hours after randomization was lower with sildenafil. Incidence of adverse effects, perinatal morbidity, and mortality were similar between the two groups.
“These results, combined with the results of other studies, are promising,” although larger studies with earlier treatment initiation are needed, the researchers wrote. Evaluation of other phosphodiesterase type 5 inhibitors also may be useful in treating preeclampsia, they noted. Dr. Trapani and his colleagues reported having no financial conflicts.
Two other studies published in the same issue of Obstetrics & Gynecology focused on using biomarkers to help predict delivery times in women with suspected preeclampsia.
Any one of several single angiogenesis-related biomarkers can be a useful diagnostic test for preeclampsia, wrote Suzy Duckworth, MBBS, of King’s College London and her colleagues. In a prospective, observational study of 423 women with suspected preeclampsia, the researchers found that a combination of biomarkers including placental growth factor (PlGF) was not significantly better than PlGF alone (receiver operating curve area of 0.90 and 0.87, respectively) for predicting preeclampsia requiring delivery within 14 days. Two other single markers, soluble fms-like tyrosine kinase-1 (sFlt-1) and endoglin, yielded similar results; each demonstrated a receiver operating curve area of 0.83.
“It is currently difficult to distinguish preeclampsia of a severity that requires early delivery from other less serious phenotypes,” the researchers wrote. “An accurate biomarker (or panel of biomarkers) to enable prognosis of perinatal complications could have a substantial effect on management strategies, with the aim of minimizing adverse maternal and fetal outcomes,” they wrote (Obstet Gynecol. 2016;128:245-252. doi: 10.1097/AOG.0000000000001508).
Dr. Duckworth had no financial conflicts to disclose, but several of her coauthors disclosed relationships with pharmaceutical companies and one coauthor is a minority shareholder in Metabolomic Diagnostics, a company with an interest in preeclampsia biomarkers.
In another study including 1,041 women with suspected preeclampsia, those with a sFlt-1:PlGF ratio greater than 38 were nearly three times as likely to deliver on the day of the test than women with an sFlt-1:PlGF ratio of 38 or less, wrote Harald Zeisler, MD, of Medical University Vienna and his colleagues (Obstet Gynecol. 2016;128:261-269. doi: 10.1097/AOG.0000000000001525).
Women with an sFlt-1:PlGF ratio greater than 38 also had significantly shorter remaining times to delivery than women with an sFlt-1:PlGF ratio of 38 or less (median 17 days vs. 51 days). The study was a secondary analysis of an observational cohort study of women aged 18 years and older from 24 to 36 6/7 weeks’ gestation.
In a preterm birth analysis of 848 women, 71% of the 184 women with an sFlt-1:PlGF ratio greater than 38 had a preterm delivery, compared with 18% of the 664 women with an sFlt-1:PlGF ratio of 38 or less.
The future clinical use of the sFlt-1:PlGF ratio “may potentially assist in informing the health care team of an impending risk to the mother, fetus, or both that may require further assessment and medical intervention,” the researchers wrote.
Dr. Zeisler and several coauthors disclosed relationships with multiple companies, including Roche Diagnostics, which sponsored the study.
FROM OBSTETRICS & GYNECOLOGY
USPSTF leans away from pelvic screening
Current evidence is insufficient to support screening pelvic exams for the early detection of certain gynecologic conditions in asymptomatic, nonpregnant women, according to a draft recommendation statement issued by the U.S. Preventive Services Task Force.
The draft recommendations and draft evidence review are available online for public comment at www.uspreventiveservicestaskforce.org through July 25, 2016.
The USPSTF defined the lack of evidence to assess the balance of benefits vs. harms of screening pelvic exams as an “I” recommendation, meaning that the balance of benefits and harms cannot be determined. The draft recommendations note that many malignant conditions including gynecologic cancers; infectious diseases such as genital herpes: and benign conditions including polyps, cysts, and fibroids, may be found during a screening pelvic exam. However, potential harms include false-positive and false-negative results, and the potential for invasive treatment and unnecessary diagnostic work-ups.
This is the first statement by the USPSTF specifically addressing pelvic exams to screen for gynecologic conditions in asymptomatic, nonpregnant women. The statement does not change any existing recommendations, such as those for screening tests for early detection of cervical cancer, chlamydia, and gonorrhea.
Pelvic exams are currently covered as part of the well-woman visit under the Affordable Care Act. “Since the coding structure doesn’t parse out individual elements of the visit, this should not result in any coverage changes,” according to the American College of Obstetricians and Gynecologists communications office.
“ACOG is reviewing the USPSTF’s draft recommendation statement and the evidence upon which it is based to assess whether there is a need to update its guidance on the routine pelvic examination,” Dr. Thomas Gellhaus, president of ACOG, said in a statement. “ACOG recommends annual pelvic examinations for patients 21 years of age or older. However, the College recognizes that this recommendation is based on expert opinion, and limitations of the internal pelvic examination for screening should be recognized.”
“The annual well-woman visit is an opportunity for the patient and her ob.gyn. to discuss whether a pelvic examination is appropriate for her. ACOG promotes shared communication and decision making between the patient and the physician regarding pelvic examinations,” said Dr. Gellhaus of the University of Iowa Hospitals and Clinics in Iowa City.
According to the USPSTF draft statement, no studies “were identified that evaluated the benefit of screening with pelvic examination on all-cause mortality, disease-specific morbidity or mortality, or quality of life.” In addition, the USPSTF “found inadequate evidence on the harms of screening for a range of gynecologic conditions with pelvic examination” and “no studies quantified the amount of anxiety associated with screening pelvic examination.”
The draft recommendations are based on a review of the evidence on the benefits, potential harms, and accuracy of screening pelvic examinations for asymptomatic, nonpregnant women aged 18 years and older. The USPSTF concluded that research is lacking in several key areas including the accuracy and efficacy of screening pelvic exams to detect conditions other than trichomoniasis, genital herpes, bacterial vaginosis, and ovarian cancer; and the potential harms (including psychological) of screening pelvic examinations for asymptomatic women.
Current evidence is insufficient to support screening pelvic exams for the early detection of certain gynecologic conditions in asymptomatic, nonpregnant women, according to a draft recommendation statement issued by the U.S. Preventive Services Task Force.
The draft recommendations and draft evidence review are available online for public comment at www.uspreventiveservicestaskforce.org through July 25, 2016.
The USPSTF defined the lack of evidence to assess the balance of benefits vs. harms of screening pelvic exams as an “I” recommendation, meaning that the balance of benefits and harms cannot be determined. The draft recommendations note that many malignant conditions including gynecologic cancers; infectious diseases such as genital herpes: and benign conditions including polyps, cysts, and fibroids, may be found during a screening pelvic exam. However, potential harms include false-positive and false-negative results, and the potential for invasive treatment and unnecessary diagnostic work-ups.
This is the first statement by the USPSTF specifically addressing pelvic exams to screen for gynecologic conditions in asymptomatic, nonpregnant women. The statement does not change any existing recommendations, such as those for screening tests for early detection of cervical cancer, chlamydia, and gonorrhea.
Pelvic exams are currently covered as part of the well-woman visit under the Affordable Care Act. “Since the coding structure doesn’t parse out individual elements of the visit, this should not result in any coverage changes,” according to the American College of Obstetricians and Gynecologists communications office.
“ACOG is reviewing the USPSTF’s draft recommendation statement and the evidence upon which it is based to assess whether there is a need to update its guidance on the routine pelvic examination,” Dr. Thomas Gellhaus, president of ACOG, said in a statement. “ACOG recommends annual pelvic examinations for patients 21 years of age or older. However, the College recognizes that this recommendation is based on expert opinion, and limitations of the internal pelvic examination for screening should be recognized.”
“The annual well-woman visit is an opportunity for the patient and her ob.gyn. to discuss whether a pelvic examination is appropriate for her. ACOG promotes shared communication and decision making between the patient and the physician regarding pelvic examinations,” said Dr. Gellhaus of the University of Iowa Hospitals and Clinics in Iowa City.
According to the USPSTF draft statement, no studies “were identified that evaluated the benefit of screening with pelvic examination on all-cause mortality, disease-specific morbidity or mortality, or quality of life.” In addition, the USPSTF “found inadequate evidence on the harms of screening for a range of gynecologic conditions with pelvic examination” and “no studies quantified the amount of anxiety associated with screening pelvic examination.”
The draft recommendations are based on a review of the evidence on the benefits, potential harms, and accuracy of screening pelvic examinations for asymptomatic, nonpregnant women aged 18 years and older. The USPSTF concluded that research is lacking in several key areas including the accuracy and efficacy of screening pelvic exams to detect conditions other than trichomoniasis, genital herpes, bacterial vaginosis, and ovarian cancer; and the potential harms (including psychological) of screening pelvic examinations for asymptomatic women.
Current evidence is insufficient to support screening pelvic exams for the early detection of certain gynecologic conditions in asymptomatic, nonpregnant women, according to a draft recommendation statement issued by the U.S. Preventive Services Task Force.
The draft recommendations and draft evidence review are available online for public comment at www.uspreventiveservicestaskforce.org through July 25, 2016.
The USPSTF defined the lack of evidence to assess the balance of benefits vs. harms of screening pelvic exams as an “I” recommendation, meaning that the balance of benefits and harms cannot be determined. The draft recommendations note that many malignant conditions including gynecologic cancers; infectious diseases such as genital herpes: and benign conditions including polyps, cysts, and fibroids, may be found during a screening pelvic exam. However, potential harms include false-positive and false-negative results, and the potential for invasive treatment and unnecessary diagnostic work-ups.
This is the first statement by the USPSTF specifically addressing pelvic exams to screen for gynecologic conditions in asymptomatic, nonpregnant women. The statement does not change any existing recommendations, such as those for screening tests for early detection of cervical cancer, chlamydia, and gonorrhea.
Pelvic exams are currently covered as part of the well-woman visit under the Affordable Care Act. “Since the coding structure doesn’t parse out individual elements of the visit, this should not result in any coverage changes,” according to the American College of Obstetricians and Gynecologists communications office.
“ACOG is reviewing the USPSTF’s draft recommendation statement and the evidence upon which it is based to assess whether there is a need to update its guidance on the routine pelvic examination,” Dr. Thomas Gellhaus, president of ACOG, said in a statement. “ACOG recommends annual pelvic examinations for patients 21 years of age or older. However, the College recognizes that this recommendation is based on expert opinion, and limitations of the internal pelvic examination for screening should be recognized.”
“The annual well-woman visit is an opportunity for the patient and her ob.gyn. to discuss whether a pelvic examination is appropriate for her. ACOG promotes shared communication and decision making between the patient and the physician regarding pelvic examinations,” said Dr. Gellhaus of the University of Iowa Hospitals and Clinics in Iowa City.
According to the USPSTF draft statement, no studies “were identified that evaluated the benefit of screening with pelvic examination on all-cause mortality, disease-specific morbidity or mortality, or quality of life.” In addition, the USPSTF “found inadequate evidence on the harms of screening for a range of gynecologic conditions with pelvic examination” and “no studies quantified the amount of anxiety associated with screening pelvic examination.”
The draft recommendations are based on a review of the evidence on the benefits, potential harms, and accuracy of screening pelvic examinations for asymptomatic, nonpregnant women aged 18 years and older. The USPSTF concluded that research is lacking in several key areas including the accuracy and efficacy of screening pelvic exams to detect conditions other than trichomoniasis, genital herpes, bacterial vaginosis, and ovarian cancer; and the potential harms (including psychological) of screening pelvic examinations for asymptomatic women.
USPSTF leans away from pelvic screening
Current evidence is insufficient to support screening pelvic exams for the early detection of certain gynecologic conditions in asymptomatic, nonpregnant women, according to a draft recommendation statement issued by the U.S. Preventive Services Task Force.
The draft recommendations and draft evidence review are available online for public comment at www.uspreventiveservicestaskforce.org through July 25, 2016.
The USPSTF defined the lack of evidence to assess the balance of benefits vs. harms of screening pelvic exams as an “I” recommendation, meaning that the balance of benefits and harms cannot be determined. The draft recommendations note that many malignant conditions including gynecologic cancers; infectious diseases such as genital herpes: and benign conditions including polyps, cysts, and fibroids, may be found during a screening pelvic exam. However, potential harms include false-positive and false-negative results, and the potential for invasive treatment and unnecessary diagnostic work-ups.
This is the first statement by the USPSTF specifically addressing pelvic exams to screen for gynecologic conditions in asymptomatic, nonpregnant women. The statement does not change any existing recommendations, such as those for screening tests for early detection of cervical cancer, chlamydia, and gonorrhea.
Pelvic exams are currently covered as part of the well-woman visit under the Affordable Care Act. “Since the coding structure doesn’t parse out individual elements of the visit, this should not result in any coverage changes,” according to the American College of Obstetricians and Gynecologists communications office.
“ACOG is reviewing the USPSTF’s draft recommendation statement and the evidence upon which it is based to assess whether there is a need to update its guidance on the routine pelvic examination,” Dr. Thomas Gellhaus, president of ACOG, said in a statement. “ACOG recommends annual pelvic examinations for patients 21 years of age or older. However, the College recognizes that this recommendation is based on expert opinion, and limitations of the internal pelvic examination for screening should be recognized.”
“The annual well-woman visit is an opportunity for the patient and her ob.gyn. to discuss whether a pelvic examination is appropriate for her. ACOG promotes shared communication and decision making between the patient and the physician regarding pelvic examinations,” said Dr. Gellhaus of the University of Iowa Hospitals and Clinics in Iowa City.
According to the USPSTF draft statement, no studies “were identified that evaluated the benefit of screening with pelvic examination on all-cause mortality, disease-specific morbidity or mortality, or quality of life.” In addition, the USPSTF “found inadequate evidence on the harms of screening for a range of gynecologic conditions with pelvic examination” and “no studies quantified the amount of anxiety associated with screening pelvic examination.”
The draft recommendations are based on a review of the evidence on the benefits, potential harms, and accuracy of screening pelvic examinations for asymptomatic, nonpregnant women aged 18 years and older. The USPSTF concluded that research is lacking in several key areas including the accuracy and efficacy of screening pelvic exams to detect conditions other than trichomoniasis, genital herpes, bacterial vaginosis, and ovarian cancer; and the potential harms (including psychological) of screening pelvic examinations for asymptomatic women.
Current evidence is insufficient to support screening pelvic exams for the early detection of certain gynecologic conditions in asymptomatic, nonpregnant women, according to a draft recommendation statement issued by the U.S. Preventive Services Task Force.
The draft recommendations and draft evidence review are available online for public comment at www.uspreventiveservicestaskforce.org through July 25, 2016.
The USPSTF defined the lack of evidence to assess the balance of benefits vs. harms of screening pelvic exams as an “I” recommendation, meaning that the balance of benefits and harms cannot be determined. The draft recommendations note that many malignant conditions including gynecologic cancers; infectious diseases such as genital herpes: and benign conditions including polyps, cysts, and fibroids, may be found during a screening pelvic exam. However, potential harms include false-positive and false-negative results, and the potential for invasive treatment and unnecessary diagnostic work-ups.
This is the first statement by the USPSTF specifically addressing pelvic exams to screen for gynecologic conditions in asymptomatic, nonpregnant women. The statement does not change any existing recommendations, such as those for screening tests for early detection of cervical cancer, chlamydia, and gonorrhea.
Pelvic exams are currently covered as part of the well-woman visit under the Affordable Care Act. “Since the coding structure doesn’t parse out individual elements of the visit, this should not result in any coverage changes,” according to the American College of Obstetricians and Gynecologists communications office.
“ACOG is reviewing the USPSTF’s draft recommendation statement and the evidence upon which it is based to assess whether there is a need to update its guidance on the routine pelvic examination,” Dr. Thomas Gellhaus, president of ACOG, said in a statement. “ACOG recommends annual pelvic examinations for patients 21 years of age or older. However, the College recognizes that this recommendation is based on expert opinion, and limitations of the internal pelvic examination for screening should be recognized.”
“The annual well-woman visit is an opportunity for the patient and her ob.gyn. to discuss whether a pelvic examination is appropriate for her. ACOG promotes shared communication and decision making between the patient and the physician regarding pelvic examinations,” said Dr. Gellhaus of the University of Iowa Hospitals and Clinics in Iowa City.
According to the USPSTF draft statement, no studies “were identified that evaluated the benefit of screening with pelvic examination on all-cause mortality, disease-specific morbidity or mortality, or quality of life.” In addition, the USPSTF “found inadequate evidence on the harms of screening for a range of gynecologic conditions with pelvic examination” and “no studies quantified the amount of anxiety associated with screening pelvic examination.”
The draft recommendations are based on a review of the evidence on the benefits, potential harms, and accuracy of screening pelvic examinations for asymptomatic, nonpregnant women aged 18 years and older. The USPSTF concluded that research is lacking in several key areas including the accuracy and efficacy of screening pelvic exams to detect conditions other than trichomoniasis, genital herpes, bacterial vaginosis, and ovarian cancer; and the potential harms (including psychological) of screening pelvic examinations for asymptomatic women.
Current evidence is insufficient to support screening pelvic exams for the early detection of certain gynecologic conditions in asymptomatic, nonpregnant women, according to a draft recommendation statement issued by the U.S. Preventive Services Task Force.
The draft recommendations and draft evidence review are available online for public comment at www.uspreventiveservicestaskforce.org through July 25, 2016.
The USPSTF defined the lack of evidence to assess the balance of benefits vs. harms of screening pelvic exams as an “I” recommendation, meaning that the balance of benefits and harms cannot be determined. The draft recommendations note that many malignant conditions including gynecologic cancers; infectious diseases such as genital herpes: and benign conditions including polyps, cysts, and fibroids, may be found during a screening pelvic exam. However, potential harms include false-positive and false-negative results, and the potential for invasive treatment and unnecessary diagnostic work-ups.
This is the first statement by the USPSTF specifically addressing pelvic exams to screen for gynecologic conditions in asymptomatic, nonpregnant women. The statement does not change any existing recommendations, such as those for screening tests for early detection of cervical cancer, chlamydia, and gonorrhea.
Pelvic exams are currently covered as part of the well-woman visit under the Affordable Care Act. “Since the coding structure doesn’t parse out individual elements of the visit, this should not result in any coverage changes,” according to the American College of Obstetricians and Gynecologists communications office.
“ACOG is reviewing the USPSTF’s draft recommendation statement and the evidence upon which it is based to assess whether there is a need to update its guidance on the routine pelvic examination,” Dr. Thomas Gellhaus, president of ACOG, said in a statement. “ACOG recommends annual pelvic examinations for patients 21 years of age or older. However, the College recognizes that this recommendation is based on expert opinion, and limitations of the internal pelvic examination for screening should be recognized.”
“The annual well-woman visit is an opportunity for the patient and her ob.gyn. to discuss whether a pelvic examination is appropriate for her. ACOG promotes shared communication and decision making between the patient and the physician regarding pelvic examinations,” said Dr. Gellhaus of the University of Iowa Hospitals and Clinics in Iowa City.
According to the USPSTF draft statement, no studies “were identified that evaluated the benefit of screening with pelvic examination on all-cause mortality, disease-specific morbidity or mortality, or quality of life.” In addition, the USPSTF “found inadequate evidence on the harms of screening for a range of gynecologic conditions with pelvic examination” and “no studies quantified the amount of anxiety associated with screening pelvic examination.”
The draft recommendations are based on a review of the evidence on the benefits, potential harms, and accuracy of screening pelvic examinations for asymptomatic, nonpregnant women aged 18 years and older. The USPSTF concluded that research is lacking in several key areas including the accuracy and efficacy of screening pelvic exams to detect conditions other than trichomoniasis, genital herpes, bacterial vaginosis, and ovarian cancer; and the potential harms (including psychological) of screening pelvic examinations for asymptomatic women.
ICU-based therapy fails to shorten hospital stay
Standardized rehabilitation therapy did not reduce hospital length of stay in patients with acute respiratory failure, based on data from a randomized trial of 300 adults published online in JAMA.
Hospital length of stay averaged 10 days for patients in the standardized rehabilitation therapy group (SRT) and 10 days in the control group that received usual ICU care, wrote Dr. Peter E. Morris of the division of pulmonary, critical care and sleep medicine at the University of Kentucky, Lexington, and his colleagues (JAMA. 2016 Jun;315:2694-702. doi: 10.1001/jama.2016.7201).
The patients were followed for 6 months; 84 patients in the SRT group and 81 in the usual group completed the study.
Patients in the SRT group received daily therapy including passive range of motion, physical therapy, and progressive-resistance exercises. The usual care group received weekday physical therapy as determined by the clinical team.
The researchers also assessed secondary outcomes related to physical function and quality of life, including ventilator days, Short Physical Performance Battery (SPPB) score, handgrip, Mini-Mental State Examination, and Functional Performance Inventory (FPI).
Overall, there was no difference in duration of ventilation or ICU care between the two groups, and score of handgrip strength and mental health also were similar at 6 months’ follow up. However, the SF-36 physical function scores were significantly higher in the SRT group (difference, 12.2; 95% confidence interval, 3.8-20.7; P = .001), and the FPI scores and SPPB scores were higher, compared with the usual care group at 6 months.
“These findings from the exploratory analysis may highlight the emerging role of placing long-term outcomes within critical care clinical trial design not only as a secondary outcome, but possibly as the primary outcome,” the researchers noted. “In view of the SPPB, SF-36 PFS, and FPI data at 6 months, the SRT group demonstrated a potential signal of improvement compared with the usual care group that was not evident at hospital discharge,” they wrote.
The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author, Dr. Morris, had no financial conflicts to disclose.
Standardized rehabilitation therapy did not reduce hospital length of stay in patients with acute respiratory failure, based on data from a randomized trial of 300 adults published online in JAMA.
Hospital length of stay averaged 10 days for patients in the standardized rehabilitation therapy group (SRT) and 10 days in the control group that received usual ICU care, wrote Dr. Peter E. Morris of the division of pulmonary, critical care and sleep medicine at the University of Kentucky, Lexington, and his colleagues (JAMA. 2016 Jun;315:2694-702. doi: 10.1001/jama.2016.7201).
The patients were followed for 6 months; 84 patients in the SRT group and 81 in the usual group completed the study.
Patients in the SRT group received daily therapy including passive range of motion, physical therapy, and progressive-resistance exercises. The usual care group received weekday physical therapy as determined by the clinical team.
The researchers also assessed secondary outcomes related to physical function and quality of life, including ventilator days, Short Physical Performance Battery (SPPB) score, handgrip, Mini-Mental State Examination, and Functional Performance Inventory (FPI).
Overall, there was no difference in duration of ventilation or ICU care between the two groups, and score of handgrip strength and mental health also were similar at 6 months’ follow up. However, the SF-36 physical function scores were significantly higher in the SRT group (difference, 12.2; 95% confidence interval, 3.8-20.7; P = .001), and the FPI scores and SPPB scores were higher, compared with the usual care group at 6 months.
“These findings from the exploratory analysis may highlight the emerging role of placing long-term outcomes within critical care clinical trial design not only as a secondary outcome, but possibly as the primary outcome,” the researchers noted. “In view of the SPPB, SF-36 PFS, and FPI data at 6 months, the SRT group demonstrated a potential signal of improvement compared with the usual care group that was not evident at hospital discharge,” they wrote.
The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author, Dr. Morris, had no financial conflicts to disclose.
Standardized rehabilitation therapy did not reduce hospital length of stay in patients with acute respiratory failure, based on data from a randomized trial of 300 adults published online in JAMA.
Hospital length of stay averaged 10 days for patients in the standardized rehabilitation therapy group (SRT) and 10 days in the control group that received usual ICU care, wrote Dr. Peter E. Morris of the division of pulmonary, critical care and sleep medicine at the University of Kentucky, Lexington, and his colleagues (JAMA. 2016 Jun;315:2694-702. doi: 10.1001/jama.2016.7201).
The patients were followed for 6 months; 84 patients in the SRT group and 81 in the usual group completed the study.
Patients in the SRT group received daily therapy including passive range of motion, physical therapy, and progressive-resistance exercises. The usual care group received weekday physical therapy as determined by the clinical team.
The researchers also assessed secondary outcomes related to physical function and quality of life, including ventilator days, Short Physical Performance Battery (SPPB) score, handgrip, Mini-Mental State Examination, and Functional Performance Inventory (FPI).
Overall, there was no difference in duration of ventilation or ICU care between the two groups, and score of handgrip strength and mental health also were similar at 6 months’ follow up. However, the SF-36 physical function scores were significantly higher in the SRT group (difference, 12.2; 95% confidence interval, 3.8-20.7; P = .001), and the FPI scores and SPPB scores were higher, compared with the usual care group at 6 months.
“These findings from the exploratory analysis may highlight the emerging role of placing long-term outcomes within critical care clinical trial design not only as a secondary outcome, but possibly as the primary outcome,” the researchers noted. “In view of the SPPB, SF-36 PFS, and FPI data at 6 months, the SRT group demonstrated a potential signal of improvement compared with the usual care group that was not evident at hospital discharge,” they wrote.
The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author, Dr. Morris, had no financial conflicts to disclose.
FROM JAMA
Key clinical point: Rehabilitation therapy in the ICU did not reduce hospital stay in patients with acute respiratory failure.
Major finding: The average length of stay was 10 days in both the therapy and control groups.
Data source: A randomized, single-center study including 300 adults with acute respiratory failure.
Disclosures: The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author Dr. Morris had no financial conflicts to disclose.
The Promise of Peanut Allergy Prevention Lies in Draft Guidelines
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
The promise of peanut allergy prevention lies in draft guidelines
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
Helmets trump face mask for noninvasive ventilation
Treating acute respiratory distress syndrome patients with helmets instead of face masks significantly reduced intubation rates and 90-day mortality rates, based on data from a randomized trial of 83 adults published in JAMA.
Acute respiratory distress syndrome (ARDS) can be treated using a face mask, but the mask is often inadequate, forcing patients to undergo intubation that can lead to additional problems including discomfort, delirium, and muscle deterioration, wrote Tianna Hicklin, Ph.D., in a column on the NIH website.
“The proposed mechanism for improved efficacy of these helmets is the preservation of applied pressures and avoidance of air leak. If the helmets indeed do allow clinicians both to be able to increase airway pressures above levels they typically would with mask-NIV and maintain those pressures without unpredictable system leak, that would be of great physiologic importance for patients with acute respiratory failure,” said Dr. Eric J. Gartman.
To explore the potential of noninvasive ventilation (NIV) using a helmet instead of a mask, both of which allow patients to remain awake in the ICU, the researchers randomized 83 adults with ARDS to treatment with either a helmet (44 patients) or a face mask (39 patients).
Intubation incidence was 18% in patients treated with helmets, compared with 62% for those treated with face masks. In addition, patients in the helmet group had significantly more ventilator-free days than the mask group (28 vs. 13; P less than .001), and both hospital mortality and 90-day mortality rates were significantly lower in the helmet group compared to the mask group (27% vs. 49%; P = .04 and 34% vs. 56%; P = .02, respectively)
Adverse event rates were rare, and similar between the helmet and mask groups. Three interface-related skin ulcers occurred in each group; nose ulcers in 7% of the mask group and neck ulcers in 7% of the helmet group.
The study population included adults aged 18 years and older who were admitted to the ICU at the University of Chicago between September 2012 and September 2015 and required face mask NIV. The average age of the patients was 58 years in the helmet group and 61 years in the mask group; there were no significant demographic differences between the groups. The most common causes of acute respiratory failure in both groups were pneumonia and pneumonia caused by immunosuppression.
The study results were limited by several factors including a lack of blinding, the need for a learning curve for clinicians using the helmet, and the potential for patient-ventilator dyssynchrony in the helmet group, noted Dr. Bhakti K. Patel of the University of Chicago and her colleagues (JAMA 2016;315:2435-41). Multicenter studies are needed to support the findings, they added. However, the findings “affirm the far-reaching benefits of spontaneous yet highly supported ventilation in an awake, animated patient over invasive medical ventilation via endotracheal tube,” they wrote. “These findings warrant further investigation of helmet NIV for patients with ARDS and other types of AHRF [acute hypoxemic respiratory failure], particularly with attention to long-term outcomes.”
The researchers had no financial conflicts to disclose.
“While the results of this study are very impressive, it is a single-center study, and obviously a larger multicenter trial (with all types of institutions included – not just large academic centers) would be helpful to elucidate the benefit of this technique and support a change in standard of care in the use of NIV. A change to this system would be a very large culture shift in NIV and would mean a significant amount of training (physician, nursing, respiratory care), purchasing the helmets, and ensuring that it is implemented properly and safely. As stated by the authors, this fact is similar to the change the occurred originally with NIV – but if their results reflect a true benefit over FM-NIV [face mask-noninvasive ventilation], such a large change would certainly be worth the effort,” Dr. Gartman said.
In a related study published in the Journal of Cardiothoracic and Vascular Anesthesia, patients treated with noninvasive positive pressure ventilation (NPPV) through helmets had significantly lower heart rates, lower average arterial pressure, and improved left ventricular ejection fraction at the end of treatment, compared with patients treated with ventilation masks and controls. Dr. Yi Yang of Capital Medical University in Beijing, China, and colleagues conducted the prospective study of 75 adults experiencing hypoxemia within 24 hours of extubation after Stanford type A aortic dissection. The participants were divided into three 25-patient groups. The control group was treated with high-flux inhalation of oxygen via a Venturi mask, another group was treated with NPPV via a mask, and the third group was treated with NPPV via a helmet. (J Card Vasc Anesth. 2016. http://dx.doi.org/10.1053/j.jvca.2016.03.129).
The study was funded by China’s public welfare industry of health.
“Several key clinical messages can be gained from the study by Patel et al.,” wrote Dr. Jeremy R. Beitler, Dr. Robert L. Owens, and Dr. Atul Malhotra, in an accompanying editorial (JAMA 2016 Jun; 315:2401-3.).
“The helmet interface has unique advantages and disadvantages that may influence efficacy of noninvasive positive pressure ventilation (NIV) depending on patient and disease characteristics,” they said. “External validation of the findings by Patel et al. and clarification of appropriate eligibility criteria, optimal ventilator settings, and potential mechanisms of effect are needed before clinicians could consider an expanded role for helmet NIV in routine management. Regardless, it is increasingly clear that there may be an important albeit underinvestigated role for some form of high-level noninvasive respiratory support to prevent intubation, and perhaps mortality, in acute hypoxemic respiratory failure,” they noted.
“In future studies, reporting of interruptions to wearing the prescribed NIV interface continuously, leak severity, biomarkers of lung injury, and sedative administration would help delineate potential mechanisms [of action],” they added.
Dr. Beitler, Dr. Owens, and Dr. Malhotra are all affiliated with the division of pulmonary and critical care medicine at the University of California, San Diego. They had no financial conflicts to disclose.
“Several key clinical messages can be gained from the study by Patel et al.,” wrote Dr. Jeremy R. Beitler, Dr. Robert L. Owens, and Dr. Atul Malhotra, in an accompanying editorial (JAMA 2016 Jun; 315:2401-3.).
“The helmet interface has unique advantages and disadvantages that may influence efficacy of noninvasive positive pressure ventilation (NIV) depending on patient and disease characteristics,” they said. “External validation of the findings by Patel et al. and clarification of appropriate eligibility criteria, optimal ventilator settings, and potential mechanisms of effect are needed before clinicians could consider an expanded role for helmet NIV in routine management. Regardless, it is increasingly clear that there may be an important albeit underinvestigated role for some form of high-level noninvasive respiratory support to prevent intubation, and perhaps mortality, in acute hypoxemic respiratory failure,” they noted.
“In future studies, reporting of interruptions to wearing the prescribed NIV interface continuously, leak severity, biomarkers of lung injury, and sedative administration would help delineate potential mechanisms [of action],” they added.
Dr. Beitler, Dr. Owens, and Dr. Malhotra are all affiliated with the division of pulmonary and critical care medicine at the University of California, San Diego. They had no financial conflicts to disclose.
“Several key clinical messages can be gained from the study by Patel et al.,” wrote Dr. Jeremy R. Beitler, Dr. Robert L. Owens, and Dr. Atul Malhotra, in an accompanying editorial (JAMA 2016 Jun; 315:2401-3.).
“The helmet interface has unique advantages and disadvantages that may influence efficacy of noninvasive positive pressure ventilation (NIV) depending on patient and disease characteristics,” they said. “External validation of the findings by Patel et al. and clarification of appropriate eligibility criteria, optimal ventilator settings, and potential mechanisms of effect are needed before clinicians could consider an expanded role for helmet NIV in routine management. Regardless, it is increasingly clear that there may be an important albeit underinvestigated role for some form of high-level noninvasive respiratory support to prevent intubation, and perhaps mortality, in acute hypoxemic respiratory failure,” they noted.
“In future studies, reporting of interruptions to wearing the prescribed NIV interface continuously, leak severity, biomarkers of lung injury, and sedative administration would help delineate potential mechanisms [of action],” they added.
Dr. Beitler, Dr. Owens, and Dr. Malhotra are all affiliated with the division of pulmonary and critical care medicine at the University of California, San Diego. They had no financial conflicts to disclose.
Treating acute respiratory distress syndrome patients with helmets instead of face masks significantly reduced intubation rates and 90-day mortality rates, based on data from a randomized trial of 83 adults published in JAMA.
Acute respiratory distress syndrome (ARDS) can be treated using a face mask, but the mask is often inadequate, forcing patients to undergo intubation that can lead to additional problems including discomfort, delirium, and muscle deterioration, wrote Tianna Hicklin, Ph.D., in a column on the NIH website.
“The proposed mechanism for improved efficacy of these helmets is the preservation of applied pressures and avoidance of air leak. If the helmets indeed do allow clinicians both to be able to increase airway pressures above levels they typically would with mask-NIV and maintain those pressures without unpredictable system leak, that would be of great physiologic importance for patients with acute respiratory failure,” said Dr. Eric J. Gartman.
To explore the potential of noninvasive ventilation (NIV) using a helmet instead of a mask, both of which allow patients to remain awake in the ICU, the researchers randomized 83 adults with ARDS to treatment with either a helmet (44 patients) or a face mask (39 patients).
Intubation incidence was 18% in patients treated with helmets, compared with 62% for those treated with face masks. In addition, patients in the helmet group had significantly more ventilator-free days than the mask group (28 vs. 13; P less than .001), and both hospital mortality and 90-day mortality rates were significantly lower in the helmet group compared to the mask group (27% vs. 49%; P = .04 and 34% vs. 56%; P = .02, respectively)
Adverse event rates were rare, and similar between the helmet and mask groups. Three interface-related skin ulcers occurred in each group; nose ulcers in 7% of the mask group and neck ulcers in 7% of the helmet group.
The study population included adults aged 18 years and older who were admitted to the ICU at the University of Chicago between September 2012 and September 2015 and required face mask NIV. The average age of the patients was 58 years in the helmet group and 61 years in the mask group; there were no significant demographic differences between the groups. The most common causes of acute respiratory failure in both groups were pneumonia and pneumonia caused by immunosuppression.
The study results were limited by several factors including a lack of blinding, the need for a learning curve for clinicians using the helmet, and the potential for patient-ventilator dyssynchrony in the helmet group, noted Dr. Bhakti K. Patel of the University of Chicago and her colleagues (JAMA 2016;315:2435-41). Multicenter studies are needed to support the findings, they added. However, the findings “affirm the far-reaching benefits of spontaneous yet highly supported ventilation in an awake, animated patient over invasive medical ventilation via endotracheal tube,” they wrote. “These findings warrant further investigation of helmet NIV for patients with ARDS and other types of AHRF [acute hypoxemic respiratory failure], particularly with attention to long-term outcomes.”
The researchers had no financial conflicts to disclose.
“While the results of this study are very impressive, it is a single-center study, and obviously a larger multicenter trial (with all types of institutions included – not just large academic centers) would be helpful to elucidate the benefit of this technique and support a change in standard of care in the use of NIV. A change to this system would be a very large culture shift in NIV and would mean a significant amount of training (physician, nursing, respiratory care), purchasing the helmets, and ensuring that it is implemented properly and safely. As stated by the authors, this fact is similar to the change the occurred originally with NIV – but if their results reflect a true benefit over FM-NIV [face mask-noninvasive ventilation], such a large change would certainly be worth the effort,” Dr. Gartman said.
In a related study published in the Journal of Cardiothoracic and Vascular Anesthesia, patients treated with noninvasive positive pressure ventilation (NPPV) through helmets had significantly lower heart rates, lower average arterial pressure, and improved left ventricular ejection fraction at the end of treatment, compared with patients treated with ventilation masks and controls. Dr. Yi Yang of Capital Medical University in Beijing, China, and colleagues conducted the prospective study of 75 adults experiencing hypoxemia within 24 hours of extubation after Stanford type A aortic dissection. The participants were divided into three 25-patient groups. The control group was treated with high-flux inhalation of oxygen via a Venturi mask, another group was treated with NPPV via a mask, and the third group was treated with NPPV via a helmet. (J Card Vasc Anesth. 2016. http://dx.doi.org/10.1053/j.jvca.2016.03.129).
The study was funded by China’s public welfare industry of health.
Treating acute respiratory distress syndrome patients with helmets instead of face masks significantly reduced intubation rates and 90-day mortality rates, based on data from a randomized trial of 83 adults published in JAMA.
Acute respiratory distress syndrome (ARDS) can be treated using a face mask, but the mask is often inadequate, forcing patients to undergo intubation that can lead to additional problems including discomfort, delirium, and muscle deterioration, wrote Tianna Hicklin, Ph.D., in a column on the NIH website.
“The proposed mechanism for improved efficacy of these helmets is the preservation of applied pressures and avoidance of air leak. If the helmets indeed do allow clinicians both to be able to increase airway pressures above levels they typically would with mask-NIV and maintain those pressures without unpredictable system leak, that would be of great physiologic importance for patients with acute respiratory failure,” said Dr. Eric J. Gartman.
To explore the potential of noninvasive ventilation (NIV) using a helmet instead of a mask, both of which allow patients to remain awake in the ICU, the researchers randomized 83 adults with ARDS to treatment with either a helmet (44 patients) or a face mask (39 patients).
Intubation incidence was 18% in patients treated with helmets, compared with 62% for those treated with face masks. In addition, patients in the helmet group had significantly more ventilator-free days than the mask group (28 vs. 13; P less than .001), and both hospital mortality and 90-day mortality rates were significantly lower in the helmet group compared to the mask group (27% vs. 49%; P = .04 and 34% vs. 56%; P = .02, respectively)
Adverse event rates were rare, and similar between the helmet and mask groups. Three interface-related skin ulcers occurred in each group; nose ulcers in 7% of the mask group and neck ulcers in 7% of the helmet group.
The study population included adults aged 18 years and older who were admitted to the ICU at the University of Chicago between September 2012 and September 2015 and required face mask NIV. The average age of the patients was 58 years in the helmet group and 61 years in the mask group; there were no significant demographic differences between the groups. The most common causes of acute respiratory failure in both groups were pneumonia and pneumonia caused by immunosuppression.
The study results were limited by several factors including a lack of blinding, the need for a learning curve for clinicians using the helmet, and the potential for patient-ventilator dyssynchrony in the helmet group, noted Dr. Bhakti K. Patel of the University of Chicago and her colleagues (JAMA 2016;315:2435-41). Multicenter studies are needed to support the findings, they added. However, the findings “affirm the far-reaching benefits of spontaneous yet highly supported ventilation in an awake, animated patient over invasive medical ventilation via endotracheal tube,” they wrote. “These findings warrant further investigation of helmet NIV for patients with ARDS and other types of AHRF [acute hypoxemic respiratory failure], particularly with attention to long-term outcomes.”
The researchers had no financial conflicts to disclose.
“While the results of this study are very impressive, it is a single-center study, and obviously a larger multicenter trial (with all types of institutions included – not just large academic centers) would be helpful to elucidate the benefit of this technique and support a change in standard of care in the use of NIV. A change to this system would be a very large culture shift in NIV and would mean a significant amount of training (physician, nursing, respiratory care), purchasing the helmets, and ensuring that it is implemented properly and safely. As stated by the authors, this fact is similar to the change the occurred originally with NIV – but if their results reflect a true benefit over FM-NIV [face mask-noninvasive ventilation], such a large change would certainly be worth the effort,” Dr. Gartman said.
In a related study published in the Journal of Cardiothoracic and Vascular Anesthesia, patients treated with noninvasive positive pressure ventilation (NPPV) through helmets had significantly lower heart rates, lower average arterial pressure, and improved left ventricular ejection fraction at the end of treatment, compared with patients treated with ventilation masks and controls. Dr. Yi Yang of Capital Medical University in Beijing, China, and colleagues conducted the prospective study of 75 adults experiencing hypoxemia within 24 hours of extubation after Stanford type A aortic dissection. The participants were divided into three 25-patient groups. The control group was treated with high-flux inhalation of oxygen via a Venturi mask, another group was treated with NPPV via a mask, and the third group was treated with NPPV via a helmet. (J Card Vasc Anesth. 2016. http://dx.doi.org/10.1053/j.jvca.2016.03.129).
The study was funded by China’s public welfare industry of health.
FROM JAMA
Key clinical point: Patients with ARDS who were treated with noninvasive continuous positive airway pressure ventilation via a helmet needed significantly less intubation and had significantly higher survival rates through 90 days than did those treated with noninvasive ventilation via face masks.
Major finding: Intubation incidence was 18% in patients treated with helmets vs. 62% for those treated with face masks; 90-day survival rates for the helmet and mask groups were 66% and 44%, respectively.
Data source: A randomized, single center study of 83 patients with ARDS.
Disclosures: The researchers had no financial conflicts to disclose. The study was funded in part by the National Heart, Lung, and Blood Institute at the National Institutes of Health.
One meal increases odds of doctors prescribing drugs
Doctors who accepted a single, industry-sponsored meal worth less than $20 were significantly more likely to prescribe the featured drug to Medicare patients, based on data from a cross-sectional study of 279,669 physicians. The findings were published online June 20 in JAMA Internal Medicine (JAMA Intern. Med. 2016 Jun. doi: 10.1001/jamainternmed.2016.2765).
In a multivariate analysis, physicians who received a single meal related to the promoted drug were 1.8 times more likely to prescribe rosuvastatin than other statins, 1.7 times more likely to prescribe nebivolol than other beta-blockers, 1.5 times more likely to prescribe olmesartan than other ACE inhibitors or ARBs, and more than twice as likely to prescribe desvenlafaxine than other SSRIs and serotonin norepinephrine reuptake inhibitors (odds ratio, 2.18).
These differences remained significant after controlling for factors including prescribing volume, physician specialty, practice setting, and demographics. Prescribing rates increased with additional meals and more expensive meals.
Previous studies have identified associations between increased prescribing and industry payments to physicians, wrote Colette DeJong, a research fellow at the University of California, San Francisco, Center for Healthcare Value, and her colleagues. However, “It is not known whether much smaller payments, such as sponsored meals, are associated with increased prescribing of the promoted brand-name drug over therapeutic alternatives,” they noted.
The researchers reviewed data from the federal Open Payments program from Aug. 1 through Dec. 31, 2013, as well as Medicare Part D prescribing data for 2013.
The results were limited by the cross-sectional nature of the study and the limitations of data from the Open Payments program, and the data reflect an association, not a cause-and-effect relationship, the researchers noted. However, “Our results are consistent with recent analyses that linked federal or state-level physician payment records with Medicare Part D prescribing data,” and with smaller studies, they said. “Future research could compare industry-sponsored meals and other methods for disseminating drug information, such as academic detailing and independent drug bulletins, with respect to the cost and quality of prescribing,” they added. The researchers had no financial conflicts to disclose.
Read the full study here: http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jamainternmed.2016.2765.
“Is it necessary to prove a causal relationship between industry payments to physicians and the prescribing of brand-name medications?” asked Dr. Robert Steinbrook in an editor’s note accompanying the study. “Other than research support, product development, and bona fide consulting related to specific research programs and projects, it is already evident that there are few reasons for physicians to have financial associations with industry,” he wrote. “Although the association between industry payments to physicians and higher rates of prescribing of brand-name medications is not in dispute, none of these studies have established a cause-and-effect relationship,” he noted. One possible reason for the association: “Physicians may choose to attend industry events where information is provided about drugs that they already prefer,” he said. However, if drug companies and device manufacturers spent less money on physician activities and more on independent safety, effectiveness, and affordability studies, “our patients and the health care system would be better off,” he said (JAMA Intern. Med. 2016, published online June 20).
Dr. Steinbrook is editor at large for JAMA Internal Medicine. He had no relevant financial conflicts to disclose.
“Is it necessary to prove a causal relationship between industry payments to physicians and the prescribing of brand-name medications?” asked Dr. Robert Steinbrook in an editor’s note accompanying the study. “Other than research support, product development, and bona fide consulting related to specific research programs and projects, it is already evident that there are few reasons for physicians to have financial associations with industry,” he wrote. “Although the association between industry payments to physicians and higher rates of prescribing of brand-name medications is not in dispute, none of these studies have established a cause-and-effect relationship,” he noted. One possible reason for the association: “Physicians may choose to attend industry events where information is provided about drugs that they already prefer,” he said. However, if drug companies and device manufacturers spent less money on physician activities and more on independent safety, effectiveness, and affordability studies, “our patients and the health care system would be better off,” he said (JAMA Intern. Med. 2016, published online June 20).
Dr. Steinbrook is editor at large for JAMA Internal Medicine. He had no relevant financial conflicts to disclose.
“Is it necessary to prove a causal relationship between industry payments to physicians and the prescribing of brand-name medications?” asked Dr. Robert Steinbrook in an editor’s note accompanying the study. “Other than research support, product development, and bona fide consulting related to specific research programs and projects, it is already evident that there are few reasons for physicians to have financial associations with industry,” he wrote. “Although the association between industry payments to physicians and higher rates of prescribing of brand-name medications is not in dispute, none of these studies have established a cause-and-effect relationship,” he noted. One possible reason for the association: “Physicians may choose to attend industry events where information is provided about drugs that they already prefer,” he said. However, if drug companies and device manufacturers spent less money on physician activities and more on independent safety, effectiveness, and affordability studies, “our patients and the health care system would be better off,” he said (JAMA Intern. Med. 2016, published online June 20).
Dr. Steinbrook is editor at large for JAMA Internal Medicine. He had no relevant financial conflicts to disclose.
Doctors who accepted a single, industry-sponsored meal worth less than $20 were significantly more likely to prescribe the featured drug to Medicare patients, based on data from a cross-sectional study of 279,669 physicians. The findings were published online June 20 in JAMA Internal Medicine (JAMA Intern. Med. 2016 Jun. doi: 10.1001/jamainternmed.2016.2765).
In a multivariate analysis, physicians who received a single meal related to the promoted drug were 1.8 times more likely to prescribe rosuvastatin than other statins, 1.7 times more likely to prescribe nebivolol than other beta-blockers, 1.5 times more likely to prescribe olmesartan than other ACE inhibitors or ARBs, and more than twice as likely to prescribe desvenlafaxine than other SSRIs and serotonin norepinephrine reuptake inhibitors (odds ratio, 2.18).
These differences remained significant after controlling for factors including prescribing volume, physician specialty, practice setting, and demographics. Prescribing rates increased with additional meals and more expensive meals.
Previous studies have identified associations between increased prescribing and industry payments to physicians, wrote Colette DeJong, a research fellow at the University of California, San Francisco, Center for Healthcare Value, and her colleagues. However, “It is not known whether much smaller payments, such as sponsored meals, are associated with increased prescribing of the promoted brand-name drug over therapeutic alternatives,” they noted.
The researchers reviewed data from the federal Open Payments program from Aug. 1 through Dec. 31, 2013, as well as Medicare Part D prescribing data for 2013.
The results were limited by the cross-sectional nature of the study and the limitations of data from the Open Payments program, and the data reflect an association, not a cause-and-effect relationship, the researchers noted. However, “Our results are consistent with recent analyses that linked federal or state-level physician payment records with Medicare Part D prescribing data,” and with smaller studies, they said. “Future research could compare industry-sponsored meals and other methods for disseminating drug information, such as academic detailing and independent drug bulletins, with respect to the cost and quality of prescribing,” they added. The researchers had no financial conflicts to disclose.
Read the full study here: http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jamainternmed.2016.2765.
Doctors who accepted a single, industry-sponsored meal worth less than $20 were significantly more likely to prescribe the featured drug to Medicare patients, based on data from a cross-sectional study of 279,669 physicians. The findings were published online June 20 in JAMA Internal Medicine (JAMA Intern. Med. 2016 Jun. doi: 10.1001/jamainternmed.2016.2765).
In a multivariate analysis, physicians who received a single meal related to the promoted drug were 1.8 times more likely to prescribe rosuvastatin than other statins, 1.7 times more likely to prescribe nebivolol than other beta-blockers, 1.5 times more likely to prescribe olmesartan than other ACE inhibitors or ARBs, and more than twice as likely to prescribe desvenlafaxine than other SSRIs and serotonin norepinephrine reuptake inhibitors (odds ratio, 2.18).
These differences remained significant after controlling for factors including prescribing volume, physician specialty, practice setting, and demographics. Prescribing rates increased with additional meals and more expensive meals.
Previous studies have identified associations between increased prescribing and industry payments to physicians, wrote Colette DeJong, a research fellow at the University of California, San Francisco, Center for Healthcare Value, and her colleagues. However, “It is not known whether much smaller payments, such as sponsored meals, are associated with increased prescribing of the promoted brand-name drug over therapeutic alternatives,” they noted.
The researchers reviewed data from the federal Open Payments program from Aug. 1 through Dec. 31, 2013, as well as Medicare Part D prescribing data for 2013.
The results were limited by the cross-sectional nature of the study and the limitations of data from the Open Payments program, and the data reflect an association, not a cause-and-effect relationship, the researchers noted. However, “Our results are consistent with recent analyses that linked federal or state-level physician payment records with Medicare Part D prescribing data,” and with smaller studies, they said. “Future research could compare industry-sponsored meals and other methods for disseminating drug information, such as academic detailing and independent drug bulletins, with respect to the cost and quality of prescribing,” they added. The researchers had no financial conflicts to disclose.
Read the full study here: http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jamainternmed.2016.2765.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Industry-sponsored meals were associated with higher prescribing rates of the featured drug to Medicare patients.
Major finding: Doctors were significantly more likely to prescribe rosuvastatin, nebivolol, and olmesartan, and more than twice as likely to prescribe desvenlafaxine (OR, 2.18) over those drugs’ competitors if they received a $20 or less complimentary meal from the company promoting the drug of interest.
Data source: A cross-sectional study of 279,669 physicians.
Disclosures: The researchers had no financial conflicts to disclose.
