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Clinicians: Be clear about flu vaccine’s value
WASHINGTON – Flu vaccination rates remain below the 70% Healthy People 2020 goal for most of the U.S. population, but data show that a recommendation from a clinician can encourage individuals to get vaccinated and to vaccinate their children, according to a panel of experts who spoke at a press briefing sponsored by the National Foundation for Infectious Diseases.
“Annual vaccination is our first line of defense against the flu,” William Schaffner, MD, of Vanderbilt University, Nashville, Tenn., said at the briefing. The unpredictable nature of the flu makes annual vaccination even more important – and the earlier, the better, said Dr. Schaffner. “If you have seen one flu season, you have seen ... one flu season.”
In a video interview at the briefing, experts emphasized the safety and effectiveness of the flu vaccine for a range of populations, including children, pregnant women, and older adults. And they offered tips to convince patients of the importance of vaccination, as well as the need to make sure health care staff are protected.
Briefing participants included former Department of Health and Human Services Secretary Thomas A. Price, MD; Patricia A. Stinchfield, RN, MS, CPNP, CIC of Children’s Hospitals and Clinics of Minnesota, St. Paul; Kathleen M. Neuzil, MD, of the University of Maryland; and Daniel B. Jernigan, MD, of the Centers for Disease Control and Prevention.
The clinicians interviewed had no financial conflicts to disclose.
WASHINGTON – Flu vaccination rates remain below the 70% Healthy People 2020 goal for most of the U.S. population, but data show that a recommendation from a clinician can encourage individuals to get vaccinated and to vaccinate their children, according to a panel of experts who spoke at a press briefing sponsored by the National Foundation for Infectious Diseases.
“Annual vaccination is our first line of defense against the flu,” William Schaffner, MD, of Vanderbilt University, Nashville, Tenn., said at the briefing. The unpredictable nature of the flu makes annual vaccination even more important – and the earlier, the better, said Dr. Schaffner. “If you have seen one flu season, you have seen ... one flu season.”
In a video interview at the briefing, experts emphasized the safety and effectiveness of the flu vaccine for a range of populations, including children, pregnant women, and older adults. And they offered tips to convince patients of the importance of vaccination, as well as the need to make sure health care staff are protected.
Briefing participants included former Department of Health and Human Services Secretary Thomas A. Price, MD; Patricia A. Stinchfield, RN, MS, CPNP, CIC of Children’s Hospitals and Clinics of Minnesota, St. Paul; Kathleen M. Neuzil, MD, of the University of Maryland; and Daniel B. Jernigan, MD, of the Centers for Disease Control and Prevention.
The clinicians interviewed had no financial conflicts to disclose.
WASHINGTON – Flu vaccination rates remain below the 70% Healthy People 2020 goal for most of the U.S. population, but data show that a recommendation from a clinician can encourage individuals to get vaccinated and to vaccinate their children, according to a panel of experts who spoke at a press briefing sponsored by the National Foundation for Infectious Diseases.
“Annual vaccination is our first line of defense against the flu,” William Schaffner, MD, of Vanderbilt University, Nashville, Tenn., said at the briefing. The unpredictable nature of the flu makes annual vaccination even more important – and the earlier, the better, said Dr. Schaffner. “If you have seen one flu season, you have seen ... one flu season.”
In a video interview at the briefing, experts emphasized the safety and effectiveness of the flu vaccine for a range of populations, including children, pregnant women, and older adults. And they offered tips to convince patients of the importance of vaccination, as well as the need to make sure health care staff are protected.
Briefing participants included former Department of Health and Human Services Secretary Thomas A. Price, MD; Patricia A. Stinchfield, RN, MS, CPNP, CIC of Children’s Hospitals and Clinics of Minnesota, St. Paul; Kathleen M. Neuzil, MD, of the University of Maryland; and Daniel B. Jernigan, MD, of the Centers for Disease Control and Prevention.
The clinicians interviewed had no financial conflicts to disclose.
AT A PRESS BRIEFING BY THE NATIONAL FOUNDATION FOR INFECTIOUS DISEASES
Lithium may reduce melanoma risk
Adults with a history of lithium exposure had a 32% lower risk of melanoma than did those who were not exposed in an unadjusted analysis of data from more than 2 million patients.
Microarray gene profiling techniques suggest that Wnt genes, which “encode a family of secreted glycoproteins that activate cellular signaling pathways to control cell differentiation, proliferation, and motility,” may be involved in melanoma development, wrote Maryam M. Asgari, MD, of the department of dermatology at Massachusetts General Hospital and the department of population medicine at Harvard University, both in Boston, and her colleagues. In particular, “transcriptional profiling of melanoma cell lines has suggested that Wnt/beta-catenin signaling regulates a transcriptional signature predictive of less aggressive melanoma,” they wrote.
The psychiatric medication lithium activates the Wnt/beta-catenin signaling pathway and has shown an ability to inhibit the proliferation of melanoma cells in a mouse model, but “to our knowledge, no published epidemiologic studies have examined the association of melanoma risk with lithium exposure,” they wrote.
The researchers reviewed data from the Kaiser Permanente Northern California database of 2,213,848 adult white patients who were members during 1997-2012, which included 11,317 with lithium exposure. They evaluated the association between lithium exposure and both incident melanoma risk and melanoma-associated mortality (J Invest Dermatol. 2017 Oct;137[10]:2087-91.).
Individuals exposed to lithium had a 32% reduced risk of melanoma in an unadjusted analysis; in an adjusted analysis, the reduced risk was 23% and was not significant.
However, there was a significant difference in melanoma incidence per 100,000 person-years in lithium-exposed individuals, compared with unexposed individuals (67.4 vs. 92.5, respectively; P = .027).
Among patients with melanoma, those with exposure to lithium had a lower mortality rate than those not exposed (4.68 vs. 7.21 per 1,000 person-years, respectively), but the sample size for this subgroup was too small to determine statistical significance. In addition, lithium exposure was associated with reduced likelihood of developing skin tumors greater than 4 mm and of presenting with extensive disease. Among those exposed to lithium, none presented with a thick tumor (Breslow depth greater than 4 mm), and none had regional or distant disease when they were diagnosed, compared with 2.8% and 6.3%, respectively, of those not exposed to lithium.
The findings were limited by several factors, including reliance on prescription information to determine lithium exposure, a homogeneous study population, and confounding variables, such as sun exposure behaviors, the researchers noted. However, the large study population adds strength to the results, and “our conclusions provide evidence that lithium, a relatively inexpensive and readily available drug, warrants further study in melanoma,” they said.
Lead author Dr. Asgari and one of the other four authors disclosed serving as investigators for studies funded by Valeant Pharmaceuticals and Pfizer. This study was supported by the National Cancer Institute. Dr. Asgari is principal investigator in the Patient-Oriented Research in the Epidemiology of Skin Diseases lab at Massachusetts General Hospital, Boston.
Adults with a history of lithium exposure had a 32% lower risk of melanoma than did those who were not exposed in an unadjusted analysis of data from more than 2 million patients.
Microarray gene profiling techniques suggest that Wnt genes, which “encode a family of secreted glycoproteins that activate cellular signaling pathways to control cell differentiation, proliferation, and motility,” may be involved in melanoma development, wrote Maryam M. Asgari, MD, of the department of dermatology at Massachusetts General Hospital and the department of population medicine at Harvard University, both in Boston, and her colleagues. In particular, “transcriptional profiling of melanoma cell lines has suggested that Wnt/beta-catenin signaling regulates a transcriptional signature predictive of less aggressive melanoma,” they wrote.
The psychiatric medication lithium activates the Wnt/beta-catenin signaling pathway and has shown an ability to inhibit the proliferation of melanoma cells in a mouse model, but “to our knowledge, no published epidemiologic studies have examined the association of melanoma risk with lithium exposure,” they wrote.
The researchers reviewed data from the Kaiser Permanente Northern California database of 2,213,848 adult white patients who were members during 1997-2012, which included 11,317 with lithium exposure. They evaluated the association between lithium exposure and both incident melanoma risk and melanoma-associated mortality (J Invest Dermatol. 2017 Oct;137[10]:2087-91.).
Individuals exposed to lithium had a 32% reduced risk of melanoma in an unadjusted analysis; in an adjusted analysis, the reduced risk was 23% and was not significant.
However, there was a significant difference in melanoma incidence per 100,000 person-years in lithium-exposed individuals, compared with unexposed individuals (67.4 vs. 92.5, respectively; P = .027).
Among patients with melanoma, those with exposure to lithium had a lower mortality rate than those not exposed (4.68 vs. 7.21 per 1,000 person-years, respectively), but the sample size for this subgroup was too small to determine statistical significance. In addition, lithium exposure was associated with reduced likelihood of developing skin tumors greater than 4 mm and of presenting with extensive disease. Among those exposed to lithium, none presented with a thick tumor (Breslow depth greater than 4 mm), and none had regional or distant disease when they were diagnosed, compared with 2.8% and 6.3%, respectively, of those not exposed to lithium.
The findings were limited by several factors, including reliance on prescription information to determine lithium exposure, a homogeneous study population, and confounding variables, such as sun exposure behaviors, the researchers noted. However, the large study population adds strength to the results, and “our conclusions provide evidence that lithium, a relatively inexpensive and readily available drug, warrants further study in melanoma,” they said.
Lead author Dr. Asgari and one of the other four authors disclosed serving as investigators for studies funded by Valeant Pharmaceuticals and Pfizer. This study was supported by the National Cancer Institute. Dr. Asgari is principal investigator in the Patient-Oriented Research in the Epidemiology of Skin Diseases lab at Massachusetts General Hospital, Boston.
Adults with a history of lithium exposure had a 32% lower risk of melanoma than did those who were not exposed in an unadjusted analysis of data from more than 2 million patients.
Microarray gene profiling techniques suggest that Wnt genes, which “encode a family of secreted glycoproteins that activate cellular signaling pathways to control cell differentiation, proliferation, and motility,” may be involved in melanoma development, wrote Maryam M. Asgari, MD, of the department of dermatology at Massachusetts General Hospital and the department of population medicine at Harvard University, both in Boston, and her colleagues. In particular, “transcriptional profiling of melanoma cell lines has suggested that Wnt/beta-catenin signaling regulates a transcriptional signature predictive of less aggressive melanoma,” they wrote.
The psychiatric medication lithium activates the Wnt/beta-catenin signaling pathway and has shown an ability to inhibit the proliferation of melanoma cells in a mouse model, but “to our knowledge, no published epidemiologic studies have examined the association of melanoma risk with lithium exposure,” they wrote.
The researchers reviewed data from the Kaiser Permanente Northern California database of 2,213,848 adult white patients who were members during 1997-2012, which included 11,317 with lithium exposure. They evaluated the association between lithium exposure and both incident melanoma risk and melanoma-associated mortality (J Invest Dermatol. 2017 Oct;137[10]:2087-91.).
Individuals exposed to lithium had a 32% reduced risk of melanoma in an unadjusted analysis; in an adjusted analysis, the reduced risk was 23% and was not significant.
However, there was a significant difference in melanoma incidence per 100,000 person-years in lithium-exposed individuals, compared with unexposed individuals (67.4 vs. 92.5, respectively; P = .027).
Among patients with melanoma, those with exposure to lithium had a lower mortality rate than those not exposed (4.68 vs. 7.21 per 1,000 person-years, respectively), but the sample size for this subgroup was too small to determine statistical significance. In addition, lithium exposure was associated with reduced likelihood of developing skin tumors greater than 4 mm and of presenting with extensive disease. Among those exposed to lithium, none presented with a thick tumor (Breslow depth greater than 4 mm), and none had regional or distant disease when they were diagnosed, compared with 2.8% and 6.3%, respectively, of those not exposed to lithium.
The findings were limited by several factors, including reliance on prescription information to determine lithium exposure, a homogeneous study population, and confounding variables, such as sun exposure behaviors, the researchers noted. However, the large study population adds strength to the results, and “our conclusions provide evidence that lithium, a relatively inexpensive and readily available drug, warrants further study in melanoma,” they said.
Lead author Dr. Asgari and one of the other four authors disclosed serving as investigators for studies funded by Valeant Pharmaceuticals and Pfizer. This study was supported by the National Cancer Institute. Dr. Asgari is principal investigator in the Patient-Oriented Research in the Epidemiology of Skin Diseases lab at Massachusetts General Hospital, Boston.
FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY
Key clinical point: Lithium may reduce the risk of melanoma and melanoma mortality.
Major finding: The incidence of melanoma was significantly lower among adults exposed to lithium (67/100,000 person-years) than those not exposed (93/100,000 person-years).
Data source: The data come from a population-based, retrospective cohort study of 11,317 white adults in Northern California.
Disclosures: The lead author and one of the other four authors disclosed serving as investigators for studies funded by Valeant Pharmaceuticals and Pfizer. The study was supported by the National Cancer Institute.
Caffeine offers no perks for Parkinson’s patients
Caffeine consumption has no significant impact on motor skills in patients with Parkinson’s disease, based on data from a double-blind, randomized, placebo-controlled trial of 121 adults. The findings were published online Sept. 27 in Neurology.
Data from previous studies have suggested a link between caffeine consumption and reduced risk of Parkinson’s disease, wrote Ronald B. Postuma, MD, of McGill University in Montreal, and his colleagues (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004568). In addition, Dr. Postuma and his coauthors found a small impact of caffeine on motor skills in patients with existing Parkinson’s as a secondary outcome in a 2012 study on the role of caffeine on daytime sleepiness. Based on these findings, they designed a multicenter, randomized, controlled trial of 121 adults with Parkinson’s to assess the impact of caffeine. The average age of the patients was 62 years and the average disease duration was 4 years.
Motor skills worsened in the caffeine group by an average of 0.16 points on the Movement Disorder Society–sponsored Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III during patients’ “on” state and by 0.64 points in the placebo group; the difference was not significant.
The researchers found no differences between groups in the clinical global impression of change based on both patient and examiner assessment. In addition, no differences appeared in depression or anxiety, or in quality of life.
The study findings included long-term follow up data from 88 patients assessed at 12 months and 66 patients assessed at 18 months. The results were similar to the 6-month results, and the study was stopped, although the original design included a 4-year extension.
A total of 29 patients in the caffeine group and 31 patients in the placebo group reported adverse events, and 7 patients in the caffeine group and 5 in the placebo group discontinued the study because of side effects. A serious adverse event was reported by one patient in each group, but neither was deemed related to the interventions.
The findings contrast with the effects of caffeine in the 6-week study in 2012 that showed a significant, 3.2-point improvement in motor skills on the MDS-UPDRS part III with caffeine use, as well as reduced daytime sleepiness, the researchers said (Neurology. 2012;79:651-8). Interpretations of the different findings between the trials may be constrained by factors including differences in the study populations, speed of dose escalation, and trial duration and the possible short-term nature of caffeine’s impact, they noted. “Regardless, our core finding is that caffeine cannot be recommended as symptomatic therapy for parkinsonism.” However, “since caffeine is safe and generally well tolerated, it seems reasonable to empirically try intermittent moderate doses of caffeine for somnolence, and repeat if improvement is seen,” they added.
Dr. Postuma disclosed grant funding from the Canadian Institute of Health Research, the Webster Foundation, and Fonds de Recherche du Québec-Santé for this study.
The appeal of an inexpensive, well-tolerated intervention such as caffeine to improve motor symptoms in Parkinson’s patients gave Dr. Postuma and his associates a good reason to try to replicate the positive results they found in an earlier study of caffeine.
The investigators found no benefit from caffeine, although their study was designed to have more than four times as many participants as the pilot study, was adequately powered to detect the same level of improvement as before, and was planned to have an extended follow-up period to look for persistent effects. The trial ended early and enrolled approximately half of its intended total, but was well run and did not suffer from differential compliance or loss to follow-up.
Although the small number of participants resulted in a wide confidence interval and cannot exclude a small effect, this trial suggests that caffeine does not significantly improve Parkinson’s disease symptoms and that it should not be a priority for future Parkinson’s disease intervention studies.
Charles B. Hall, PhD, is affiliated with the department of epidemiology and population health at Albert Einstein College of Medicine, New York. He disclosed salary support from the National Institute of Occupational Safety and Health, National Institute of Aging, National Cancer Institute, and National Center for Advancing Translational Sciences. His comments are derived from an editorial that accompanied Dr. Postuma and colleagues’ study (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004584).
The appeal of an inexpensive, well-tolerated intervention such as caffeine to improve motor symptoms in Parkinson’s patients gave Dr. Postuma and his associates a good reason to try to replicate the positive results they found in an earlier study of caffeine.
The investigators found no benefit from caffeine, although their study was designed to have more than four times as many participants as the pilot study, was adequately powered to detect the same level of improvement as before, and was planned to have an extended follow-up period to look for persistent effects. The trial ended early and enrolled approximately half of its intended total, but was well run and did not suffer from differential compliance or loss to follow-up.
Although the small number of participants resulted in a wide confidence interval and cannot exclude a small effect, this trial suggests that caffeine does not significantly improve Parkinson’s disease symptoms and that it should not be a priority for future Parkinson’s disease intervention studies.
Charles B. Hall, PhD, is affiliated with the department of epidemiology and population health at Albert Einstein College of Medicine, New York. He disclosed salary support from the National Institute of Occupational Safety and Health, National Institute of Aging, National Cancer Institute, and National Center for Advancing Translational Sciences. His comments are derived from an editorial that accompanied Dr. Postuma and colleagues’ study (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004584).
The appeal of an inexpensive, well-tolerated intervention such as caffeine to improve motor symptoms in Parkinson’s patients gave Dr. Postuma and his associates a good reason to try to replicate the positive results they found in an earlier study of caffeine.
The investigators found no benefit from caffeine, although their study was designed to have more than four times as many participants as the pilot study, was adequately powered to detect the same level of improvement as before, and was planned to have an extended follow-up period to look for persistent effects. The trial ended early and enrolled approximately half of its intended total, but was well run and did not suffer from differential compliance or loss to follow-up.
Although the small number of participants resulted in a wide confidence interval and cannot exclude a small effect, this trial suggests that caffeine does not significantly improve Parkinson’s disease symptoms and that it should not be a priority for future Parkinson’s disease intervention studies.
Charles B. Hall, PhD, is affiliated with the department of epidemiology and population health at Albert Einstein College of Medicine, New York. He disclosed salary support from the National Institute of Occupational Safety and Health, National Institute of Aging, National Cancer Institute, and National Center for Advancing Translational Sciences. His comments are derived from an editorial that accompanied Dr. Postuma and colleagues’ study (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004584).
Caffeine consumption has no significant impact on motor skills in patients with Parkinson’s disease, based on data from a double-blind, randomized, placebo-controlled trial of 121 adults. The findings were published online Sept. 27 in Neurology.
Data from previous studies have suggested a link between caffeine consumption and reduced risk of Parkinson’s disease, wrote Ronald B. Postuma, MD, of McGill University in Montreal, and his colleagues (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004568). In addition, Dr. Postuma and his coauthors found a small impact of caffeine on motor skills in patients with existing Parkinson’s as a secondary outcome in a 2012 study on the role of caffeine on daytime sleepiness. Based on these findings, they designed a multicenter, randomized, controlled trial of 121 adults with Parkinson’s to assess the impact of caffeine. The average age of the patients was 62 years and the average disease duration was 4 years.
Motor skills worsened in the caffeine group by an average of 0.16 points on the Movement Disorder Society–sponsored Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III during patients’ “on” state and by 0.64 points in the placebo group; the difference was not significant.
The researchers found no differences between groups in the clinical global impression of change based on both patient and examiner assessment. In addition, no differences appeared in depression or anxiety, or in quality of life.
The study findings included long-term follow up data from 88 patients assessed at 12 months and 66 patients assessed at 18 months. The results were similar to the 6-month results, and the study was stopped, although the original design included a 4-year extension.
A total of 29 patients in the caffeine group and 31 patients in the placebo group reported adverse events, and 7 patients in the caffeine group and 5 in the placebo group discontinued the study because of side effects. A serious adverse event was reported by one patient in each group, but neither was deemed related to the interventions.
The findings contrast with the effects of caffeine in the 6-week study in 2012 that showed a significant, 3.2-point improvement in motor skills on the MDS-UPDRS part III with caffeine use, as well as reduced daytime sleepiness, the researchers said (Neurology. 2012;79:651-8). Interpretations of the different findings between the trials may be constrained by factors including differences in the study populations, speed of dose escalation, and trial duration and the possible short-term nature of caffeine’s impact, they noted. “Regardless, our core finding is that caffeine cannot be recommended as symptomatic therapy for parkinsonism.” However, “since caffeine is safe and generally well tolerated, it seems reasonable to empirically try intermittent moderate doses of caffeine for somnolence, and repeat if improvement is seen,” they added.
Dr. Postuma disclosed grant funding from the Canadian Institute of Health Research, the Webster Foundation, and Fonds de Recherche du Québec-Santé for this study.
Caffeine consumption has no significant impact on motor skills in patients with Parkinson’s disease, based on data from a double-blind, randomized, placebo-controlled trial of 121 adults. The findings were published online Sept. 27 in Neurology.
Data from previous studies have suggested a link between caffeine consumption and reduced risk of Parkinson’s disease, wrote Ronald B. Postuma, MD, of McGill University in Montreal, and his colleagues (Neurology. 2017 Sep 27. doi: 10.1212/WNL.0000000000004568). In addition, Dr. Postuma and his coauthors found a small impact of caffeine on motor skills in patients with existing Parkinson’s as a secondary outcome in a 2012 study on the role of caffeine on daytime sleepiness. Based on these findings, they designed a multicenter, randomized, controlled trial of 121 adults with Parkinson’s to assess the impact of caffeine. The average age of the patients was 62 years and the average disease duration was 4 years.
Motor skills worsened in the caffeine group by an average of 0.16 points on the Movement Disorder Society–sponsored Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III during patients’ “on” state and by 0.64 points in the placebo group; the difference was not significant.
The researchers found no differences between groups in the clinical global impression of change based on both patient and examiner assessment. In addition, no differences appeared in depression or anxiety, or in quality of life.
The study findings included long-term follow up data from 88 patients assessed at 12 months and 66 patients assessed at 18 months. The results were similar to the 6-month results, and the study was stopped, although the original design included a 4-year extension.
A total of 29 patients in the caffeine group and 31 patients in the placebo group reported adverse events, and 7 patients in the caffeine group and 5 in the placebo group discontinued the study because of side effects. A serious adverse event was reported by one patient in each group, but neither was deemed related to the interventions.
The findings contrast with the effects of caffeine in the 6-week study in 2012 that showed a significant, 3.2-point improvement in motor skills on the MDS-UPDRS part III with caffeine use, as well as reduced daytime sleepiness, the researchers said (Neurology. 2012;79:651-8). Interpretations of the different findings between the trials may be constrained by factors including differences in the study populations, speed of dose escalation, and trial duration and the possible short-term nature of caffeine’s impact, they noted. “Regardless, our core finding is that caffeine cannot be recommended as symptomatic therapy for parkinsonism.” However, “since caffeine is safe and generally well tolerated, it seems reasonable to empirically try intermittent moderate doses of caffeine for somnolence, and repeat if improvement is seen,” they added.
Dr. Postuma disclosed grant funding from the Canadian Institute of Health Research, the Webster Foundation, and Fonds de Recherche du Québec-Santé for this study.
FROM NEUROLOGY
Key clinical point:
Major finding: Motor skills declined by an average of 0.16 points in the caffeine group and 0.64 points in the placebo group; the difference was not significant.
Data source: A double-blind, multicenter, placebo-controlled trial of 121 adults with Parkinson’s.
Disclosures: Dr. Postuma disclosed grant funding from the Canadian Institute of Health Research, the Webster Foundation, and Fonds de Recherche du Québec-Santé for this study.
Consider adding chemotherapy after GI surgery
Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.
Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).
The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.
The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.
The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.
However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.
The researchers had no financial conflicts to disclose.
The study findings “seem to indicate that additional systemic chemotherapy could be advantageous for patients treated with neoadjuvant chemoradiotherapy for resectable gastroesophageal cancer,” wrote David Cunningham, MD, FMedSci, and Elizabeth C. Smyth, MB, BCh., MSc., in an accompanying editorial.
“The small percentage of patients treated with adjuvant chemotherapy is reassuring; neoadjuvant chemoradiotherapy and surgery followed by adjuvant chemotherapy is not a treatment approach endorsed by current national or international guidelines,” they noted. The findings suggest that the 4% increase in overall survival at 3 years is promising because most gastroesophageal cancer recurrences arise within 3 years of surgery, they said. “However, these results require validation in the form of a randomized clinical trial,” they emphasized (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2792).
Dr. Cunningham and Ms. Smyth are affiliated with the department of gastrointestinal oncology and lymphoma at the Royal Marsden Hospital, London. Dr. Cunningham disclosed institutional research funding from Amgen, AstraZeneca, Bayer, Celgene, MedImmune, Merck Serono, Merrimack, and Sanofi. Ms. Smyth disclosed honoraria for advisory roles with Five Prime Therapeutics, Bristol-Myers Squibb, and Gritstone Oncology.
The study findings “seem to indicate that additional systemic chemotherapy could be advantageous for patients treated with neoadjuvant chemoradiotherapy for resectable gastroesophageal cancer,” wrote David Cunningham, MD, FMedSci, and Elizabeth C. Smyth, MB, BCh., MSc., in an accompanying editorial.
“The small percentage of patients treated with adjuvant chemotherapy is reassuring; neoadjuvant chemoradiotherapy and surgery followed by adjuvant chemotherapy is not a treatment approach endorsed by current national or international guidelines,” they noted. The findings suggest that the 4% increase in overall survival at 3 years is promising because most gastroesophageal cancer recurrences arise within 3 years of surgery, they said. “However, these results require validation in the form of a randomized clinical trial,” they emphasized (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2792).
Dr. Cunningham and Ms. Smyth are affiliated with the department of gastrointestinal oncology and lymphoma at the Royal Marsden Hospital, London. Dr. Cunningham disclosed institutional research funding from Amgen, AstraZeneca, Bayer, Celgene, MedImmune, Merck Serono, Merrimack, and Sanofi. Ms. Smyth disclosed honoraria for advisory roles with Five Prime Therapeutics, Bristol-Myers Squibb, and Gritstone Oncology.
The study findings “seem to indicate that additional systemic chemotherapy could be advantageous for patients treated with neoadjuvant chemoradiotherapy for resectable gastroesophageal cancer,” wrote David Cunningham, MD, FMedSci, and Elizabeth C. Smyth, MB, BCh., MSc., in an accompanying editorial.
“The small percentage of patients treated with adjuvant chemotherapy is reassuring; neoadjuvant chemoradiotherapy and surgery followed by adjuvant chemotherapy is not a treatment approach endorsed by current national or international guidelines,” they noted. The findings suggest that the 4% increase in overall survival at 3 years is promising because most gastroesophageal cancer recurrences arise within 3 years of surgery, they said. “However, these results require validation in the form of a randomized clinical trial,” they emphasized (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2792).
Dr. Cunningham and Ms. Smyth are affiliated with the department of gastrointestinal oncology and lymphoma at the Royal Marsden Hospital, London. Dr. Cunningham disclosed institutional research funding from Amgen, AstraZeneca, Bayer, Celgene, MedImmune, Merck Serono, Merrimack, and Sanofi. Ms. Smyth disclosed honoraria for advisory roles with Five Prime Therapeutics, Bristol-Myers Squibb, and Gritstone Oncology.
Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.
Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).
The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.
The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.
The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.
However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.
The researchers had no financial conflicts to disclose.
Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.
Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).
The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.
The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.
The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.
However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.
The researchers had no financial conflicts to disclose.
FROM JAMA ONCOLOGY
Key clinical point: Patients undergoing surgery for gastroesophageal cancer may benefit from additional chemotherapy.
Major finding: Overall survival rates improved in patients who received adjuvant chemotherapy, compared with those who did not (40 months vs. 34 months, respectively).
Data source: A review of 10,086 adults in the National Cancer Database who underwent gastroesophageal cancer surgery during 2006-2013.
Disclosures: The researchers had no financial conflicts to disclose.
Battling physician burnout delivers monetary benefits for health care organizations
The financial impact of physician burnout can provide a guide to help organizations address the problem, according to a special communication published online in JAMA Internal Medicine.
Approximately half of U.S. physicians experience some degree of professional burnout, but health care organizations have done little to respond, wrote Tait Shanafelt, MD, of Stanford (Calif.) University, and colleagues (JAMA Intern Med. 2017 Sep 25. doi: 10.1001/jamainternmed.2017.4340).
The researchers cited “a lack of awareness regarding the economic costs of physician burnout” and a lack of confidence that anything can be done as key factors in why the organizational response to burnout has been so limited.
The business end of physician burnout includes the costs associated with physician turnover and decreased productivity, as well as “financial risks to the organization’s long-term viability due to the relationship between burnout and lower quality of care, decreased patient satisfaction, and problems with patient safety,” the researchers said.
Organizations can combat physician burnout, the authors noted, and the effort is financially worthwhile, as well as morally and ethically important. “Burnout is primarily a system-level problem driven by excess job demands and inadequate resources and support, not an individual problem triggered by personal limitations,” they wrote.
The researchers developed a model outlining “Typical Steps in an Organization’s Journey Toward Expertise in Physician Well-being.” The steps begin with strategies that have a minor impact, including awareness of the problem of physician burnout and a focus on individual interventions such as mindfulness training, exercise, and nutrition.
However, the “transformative” changes in an organization include developing a “culture of wellness,” strategic investment in physician well-being, the presence of a “chief well-being officer” at the executive level, and accountability for physician wellness shared among organizational leaders.
The cost of such strategies varies among institutions, and the researchers provided worksheets to calculate the organizational cost of burnout and the return on investment if intervention steps are taken.
For example, an organization employing 450 physicians could potentially spend $1 million per year on an intervention to reduce physician burnout from 50% to 40%. The intervention investment could yield organizational cost savings of $1.125 million per year, with a 12.5% return on investment, as well as the potential financial benefits of improved patient satisfaction and quality of care.
“Understanding the business case to reduce burnout and promote engagement, as well as overcoming the misperception that nothing meaningful can be done, are key steps for organizations to begin to take action,” the researchers concluded.
“Improvement is possible, investment is justified, and return on investment measurable,” they said.
Dr. Shanafelt is a coinventor of the Physician Well-Being Index, Medical Student Well-Being Index, and Well-Being Index; copyright and licensing rights for these tools belong to the Mayo Clinic, and Dr. Shanafelt receives part of the royalties. The researchers had no other financial conflicts to disclose.
The financial impact of physician burnout can provide a guide to help organizations address the problem, according to a special communication published online in JAMA Internal Medicine.
Approximately half of U.S. physicians experience some degree of professional burnout, but health care organizations have done little to respond, wrote Tait Shanafelt, MD, of Stanford (Calif.) University, and colleagues (JAMA Intern Med. 2017 Sep 25. doi: 10.1001/jamainternmed.2017.4340).
The researchers cited “a lack of awareness regarding the economic costs of physician burnout” and a lack of confidence that anything can be done as key factors in why the organizational response to burnout has been so limited.
The business end of physician burnout includes the costs associated with physician turnover and decreased productivity, as well as “financial risks to the organization’s long-term viability due to the relationship between burnout and lower quality of care, decreased patient satisfaction, and problems with patient safety,” the researchers said.
Organizations can combat physician burnout, the authors noted, and the effort is financially worthwhile, as well as morally and ethically important. “Burnout is primarily a system-level problem driven by excess job demands and inadequate resources and support, not an individual problem triggered by personal limitations,” they wrote.
The researchers developed a model outlining “Typical Steps in an Organization’s Journey Toward Expertise in Physician Well-being.” The steps begin with strategies that have a minor impact, including awareness of the problem of physician burnout and a focus on individual interventions such as mindfulness training, exercise, and nutrition.
However, the “transformative” changes in an organization include developing a “culture of wellness,” strategic investment in physician well-being, the presence of a “chief well-being officer” at the executive level, and accountability for physician wellness shared among organizational leaders.
The cost of such strategies varies among institutions, and the researchers provided worksheets to calculate the organizational cost of burnout and the return on investment if intervention steps are taken.
For example, an organization employing 450 physicians could potentially spend $1 million per year on an intervention to reduce physician burnout from 50% to 40%. The intervention investment could yield organizational cost savings of $1.125 million per year, with a 12.5% return on investment, as well as the potential financial benefits of improved patient satisfaction and quality of care.
“Understanding the business case to reduce burnout and promote engagement, as well as overcoming the misperception that nothing meaningful can be done, are key steps for organizations to begin to take action,” the researchers concluded.
“Improvement is possible, investment is justified, and return on investment measurable,” they said.
Dr. Shanafelt is a coinventor of the Physician Well-Being Index, Medical Student Well-Being Index, and Well-Being Index; copyright and licensing rights for these tools belong to the Mayo Clinic, and Dr. Shanafelt receives part of the royalties. The researchers had no other financial conflicts to disclose.
The financial impact of physician burnout can provide a guide to help organizations address the problem, according to a special communication published online in JAMA Internal Medicine.
Approximately half of U.S. physicians experience some degree of professional burnout, but health care organizations have done little to respond, wrote Tait Shanafelt, MD, of Stanford (Calif.) University, and colleagues (JAMA Intern Med. 2017 Sep 25. doi: 10.1001/jamainternmed.2017.4340).
The researchers cited “a lack of awareness regarding the economic costs of physician burnout” and a lack of confidence that anything can be done as key factors in why the organizational response to burnout has been so limited.
The business end of physician burnout includes the costs associated with physician turnover and decreased productivity, as well as “financial risks to the organization’s long-term viability due to the relationship between burnout and lower quality of care, decreased patient satisfaction, and problems with patient safety,” the researchers said.
Organizations can combat physician burnout, the authors noted, and the effort is financially worthwhile, as well as morally and ethically important. “Burnout is primarily a system-level problem driven by excess job demands and inadequate resources and support, not an individual problem triggered by personal limitations,” they wrote.
The researchers developed a model outlining “Typical Steps in an Organization’s Journey Toward Expertise in Physician Well-being.” The steps begin with strategies that have a minor impact, including awareness of the problem of physician burnout and a focus on individual interventions such as mindfulness training, exercise, and nutrition.
However, the “transformative” changes in an organization include developing a “culture of wellness,” strategic investment in physician well-being, the presence of a “chief well-being officer” at the executive level, and accountability for physician wellness shared among organizational leaders.
The cost of such strategies varies among institutions, and the researchers provided worksheets to calculate the organizational cost of burnout and the return on investment if intervention steps are taken.
For example, an organization employing 450 physicians could potentially spend $1 million per year on an intervention to reduce physician burnout from 50% to 40%. The intervention investment could yield organizational cost savings of $1.125 million per year, with a 12.5% return on investment, as well as the potential financial benefits of improved patient satisfaction and quality of care.
“Understanding the business case to reduce burnout and promote engagement, as well as overcoming the misperception that nothing meaningful can be done, are key steps for organizations to begin to take action,” the researchers concluded.
“Improvement is possible, investment is justified, and return on investment measurable,” they said.
Dr. Shanafelt is a coinventor of the Physician Well-Being Index, Medical Student Well-Being Index, and Well-Being Index; copyright and licensing rights for these tools belong to the Mayo Clinic, and Dr. Shanafelt receives part of the royalties. The researchers had no other financial conflicts to disclose.
FROM JAMA INTERNAL MEDICINE
Early cognitive impairment associated with later Parkinson’s disease
Adults with early cognitive impairment are at greater risk for developing parkinsonism than those without cognitive impairment, based on data from 7,386 adults participating in the ongoing Rotterdam Study. The findings were published online Sept. 25 in JAMA Neurology.
“Between 15% and 43% of patients with newly diagnosed Parkinson disease (PD) are cognitively impaired,” wrote Sirwan K. L. Darweesh, MD, of Erasmus MC University Medical Center, Rotterdam, the Netherlands, and his colleagues. However, data on the predictive value of cognitive impairment for parkinsonism has not been well studied, they wrote (JAMA Neurol. 2017. doi: 10.1001/jamaneurol.2017.2248).
Over approximately 8 years’ follow-up, 1% of the participants were diagnosed with incident parkinsonism.
“Poor global cognition at baseline was associated with a higher risk of incident parkinsonism” with a hazard ratio of 1.79, the researchers said.
“To enable translation of our findings to clinical practice, we present likelihood ratios (LRs) for the baseline presence of isolated or combined cognitive dysfunction and subtle motor features for incident parkinsonism during follow-up,” they noted.
Approximately half of participants diagnosed with incident parkinsonism during the study period had subtle motor features, cognitive dysfunction, or both, at baseline. Baseline cognitive impairment alone showed a likelihood ratio of 1.76 for development of parkinsonism, but the likelihood ratio was greater when both cognitive impairment and subtle motor findings were present (2.66).
“In individuals who received a diagnosis of both incident dementia and incident parkinsonism, baseline cognitive dysfunction was not associated with incident dementia,” the researchers noted.
The researchers determined that the most likely explanation for the association between cognitive decline and increased Parkinson’s risk was that “low baseline cognitive scores may indicate ongoing cognitive decline in prediagnostic patients who probably will develop parkinsonism, most of whom have prediagnostic PD,” they said.
The study findings were limited by several factors including the potential misclassification of parkinsonism diagnosis, the researchers noted. However, the association between poor cognitive function and the risk of parkinsonism and probably Parkinson’s disease remained for the executive, attention, cognitive speed, and memory domains of cognition, they said. “Our findings suggest that poor cognitive functioning can be considered a prodromal sign of PD,” they concluded.
This study was supported in part by Stichting ParkinsonFonds. The researchers had no financial conflicts to disclose.
The long-term nature of the Rotterdam Study makes it an excellent source for examining the association between poor cognition and parkinsonism, wrote Ethan G. Brown, MD, and Caroline M. Tanner, MD, in an accompanying editorial.
“This study reiterates the presence of cognitive impairment very early in PD, emphasizing the need for therapeutic trials to target this symptom as an outcome. Although only some patients with cognitive impairment progress to PD, the study provides some clues on how to distinguish those most at risk. Progression to parkinsonism was more likely with baseline impairment of several individual cognitive tests, but only changes in semantic fluency predicted probable PD. Semantic fluency has been previously found to be specific for progression of cognitive impairment in PD, and this study again suggests the importance of this cognitive test early on,” they wrote.
“Yet the presence of cognitive impairment so early also gives rise to questions about the underlying pathology of PD progression. A commonly cited mechanism for progression of PD involves prion-like spread of synuclein pathology up through the dorsal nucleus of the vagus and substantia nigra. This spread presumably causes the autonomic, sleep, and motor dysfunction common in PD and supposedly leads to cognitive impairment only once Lewy bodies enter the neocortex. The current evidence that cognitive impairment can be evident in the prodromal stage challenges the universality of the model of vagal spread,” they noted.
However, recognizing the role of cognitive impairment as an early sign of PD can help clinicians plan screening and care, they said.
“This recognition can allow physicians to screen for falls or other nonmotor aspects of PD in these cases and provide early treatment for these symptoms. Physicians may recommend interventions, such as physical activity, that are helpful for motor and cognitive changes in PD,” they added (JAMA Neurol. 2017. doi: 10.1001/jamaneurol.2017.1474).
Dr. Brown and Dr. Tanner are affiliated with the Movement Disorders and Neuromodulation Center in the department of neurology at the University of California, San Francisco. Dr. Brown disclosed compensation for serving on the Fellowship Advisory Board for AbbVie. Dr. Tanner disclosed grants from a variety of nonprofit sources, as well as compensation for serving on Data Monitoring Committees for Biotie Therapeutics, Voyager Therapeutics, and Intec Pharma. Dr. Tanner also disclosed personal consulting fees from Neurocrine Biosciences, Adamas Therapeutics, and PhotoPharmics.
The long-term nature of the Rotterdam Study makes it an excellent source for examining the association between poor cognition and parkinsonism, wrote Ethan G. Brown, MD, and Caroline M. Tanner, MD, in an accompanying editorial.
“This study reiterates the presence of cognitive impairment very early in PD, emphasizing the need for therapeutic trials to target this symptom as an outcome. Although only some patients with cognitive impairment progress to PD, the study provides some clues on how to distinguish those most at risk. Progression to parkinsonism was more likely with baseline impairment of several individual cognitive tests, but only changes in semantic fluency predicted probable PD. Semantic fluency has been previously found to be specific for progression of cognitive impairment in PD, and this study again suggests the importance of this cognitive test early on,” they wrote.
“Yet the presence of cognitive impairment so early also gives rise to questions about the underlying pathology of PD progression. A commonly cited mechanism for progression of PD involves prion-like spread of synuclein pathology up through the dorsal nucleus of the vagus and substantia nigra. This spread presumably causes the autonomic, sleep, and motor dysfunction common in PD and supposedly leads to cognitive impairment only once Lewy bodies enter the neocortex. The current evidence that cognitive impairment can be evident in the prodromal stage challenges the universality of the model of vagal spread,” they noted.
However, recognizing the role of cognitive impairment as an early sign of PD can help clinicians plan screening and care, they said.
“This recognition can allow physicians to screen for falls or other nonmotor aspects of PD in these cases and provide early treatment for these symptoms. Physicians may recommend interventions, such as physical activity, that are helpful for motor and cognitive changes in PD,” they added (JAMA Neurol. 2017. doi: 10.1001/jamaneurol.2017.1474).
Dr. Brown and Dr. Tanner are affiliated with the Movement Disorders and Neuromodulation Center in the department of neurology at the University of California, San Francisco. Dr. Brown disclosed compensation for serving on the Fellowship Advisory Board for AbbVie. Dr. Tanner disclosed grants from a variety of nonprofit sources, as well as compensation for serving on Data Monitoring Committees for Biotie Therapeutics, Voyager Therapeutics, and Intec Pharma. Dr. Tanner also disclosed personal consulting fees from Neurocrine Biosciences, Adamas Therapeutics, and PhotoPharmics.
The long-term nature of the Rotterdam Study makes it an excellent source for examining the association between poor cognition and parkinsonism, wrote Ethan G. Brown, MD, and Caroline M. Tanner, MD, in an accompanying editorial.
“This study reiterates the presence of cognitive impairment very early in PD, emphasizing the need for therapeutic trials to target this symptom as an outcome. Although only some patients with cognitive impairment progress to PD, the study provides some clues on how to distinguish those most at risk. Progression to parkinsonism was more likely with baseline impairment of several individual cognitive tests, but only changes in semantic fluency predicted probable PD. Semantic fluency has been previously found to be specific for progression of cognitive impairment in PD, and this study again suggests the importance of this cognitive test early on,” they wrote.
“Yet the presence of cognitive impairment so early also gives rise to questions about the underlying pathology of PD progression. A commonly cited mechanism for progression of PD involves prion-like spread of synuclein pathology up through the dorsal nucleus of the vagus and substantia nigra. This spread presumably causes the autonomic, sleep, and motor dysfunction common in PD and supposedly leads to cognitive impairment only once Lewy bodies enter the neocortex. The current evidence that cognitive impairment can be evident in the prodromal stage challenges the universality of the model of vagal spread,” they noted.
However, recognizing the role of cognitive impairment as an early sign of PD can help clinicians plan screening and care, they said.
“This recognition can allow physicians to screen for falls or other nonmotor aspects of PD in these cases and provide early treatment for these symptoms. Physicians may recommend interventions, such as physical activity, that are helpful for motor and cognitive changes in PD,” they added (JAMA Neurol. 2017. doi: 10.1001/jamaneurol.2017.1474).
Dr. Brown and Dr. Tanner are affiliated with the Movement Disorders and Neuromodulation Center in the department of neurology at the University of California, San Francisco. Dr. Brown disclosed compensation for serving on the Fellowship Advisory Board for AbbVie. Dr. Tanner disclosed grants from a variety of nonprofit sources, as well as compensation for serving on Data Monitoring Committees for Biotie Therapeutics, Voyager Therapeutics, and Intec Pharma. Dr. Tanner also disclosed personal consulting fees from Neurocrine Biosciences, Adamas Therapeutics, and PhotoPharmics.
Adults with early cognitive impairment are at greater risk for developing parkinsonism than those without cognitive impairment, based on data from 7,386 adults participating in the ongoing Rotterdam Study. The findings were published online Sept. 25 in JAMA Neurology.
“Between 15% and 43% of patients with newly diagnosed Parkinson disease (PD) are cognitively impaired,” wrote Sirwan K. L. Darweesh, MD, of Erasmus MC University Medical Center, Rotterdam, the Netherlands, and his colleagues. However, data on the predictive value of cognitive impairment for parkinsonism has not been well studied, they wrote (JAMA Neurol. 2017. doi: 10.1001/jamaneurol.2017.2248).
Over approximately 8 years’ follow-up, 1% of the participants were diagnosed with incident parkinsonism.
“Poor global cognition at baseline was associated with a higher risk of incident parkinsonism” with a hazard ratio of 1.79, the researchers said.
“To enable translation of our findings to clinical practice, we present likelihood ratios (LRs) for the baseline presence of isolated or combined cognitive dysfunction and subtle motor features for incident parkinsonism during follow-up,” they noted.
Approximately half of participants diagnosed with incident parkinsonism during the study period had subtle motor features, cognitive dysfunction, or both, at baseline. Baseline cognitive impairment alone showed a likelihood ratio of 1.76 for development of parkinsonism, but the likelihood ratio was greater when both cognitive impairment and subtle motor findings were present (2.66).
“In individuals who received a diagnosis of both incident dementia and incident parkinsonism, baseline cognitive dysfunction was not associated with incident dementia,” the researchers noted.
The researchers determined that the most likely explanation for the association between cognitive decline and increased Parkinson’s risk was that “low baseline cognitive scores may indicate ongoing cognitive decline in prediagnostic patients who probably will develop parkinsonism, most of whom have prediagnostic PD,” they said.
The study findings were limited by several factors including the potential misclassification of parkinsonism diagnosis, the researchers noted. However, the association between poor cognitive function and the risk of parkinsonism and probably Parkinson’s disease remained for the executive, attention, cognitive speed, and memory domains of cognition, they said. “Our findings suggest that poor cognitive functioning can be considered a prodromal sign of PD,” they concluded.
This study was supported in part by Stichting ParkinsonFonds. The researchers had no financial conflicts to disclose.
Adults with early cognitive impairment are at greater risk for developing parkinsonism than those without cognitive impairment, based on data from 7,386 adults participating in the ongoing Rotterdam Study. The findings were published online Sept. 25 in JAMA Neurology.
“Between 15% and 43% of patients with newly diagnosed Parkinson disease (PD) are cognitively impaired,” wrote Sirwan K. L. Darweesh, MD, of Erasmus MC University Medical Center, Rotterdam, the Netherlands, and his colleagues. However, data on the predictive value of cognitive impairment for parkinsonism has not been well studied, they wrote (JAMA Neurol. 2017. doi: 10.1001/jamaneurol.2017.2248).
Over approximately 8 years’ follow-up, 1% of the participants were diagnosed with incident parkinsonism.
“Poor global cognition at baseline was associated with a higher risk of incident parkinsonism” with a hazard ratio of 1.79, the researchers said.
“To enable translation of our findings to clinical practice, we present likelihood ratios (LRs) for the baseline presence of isolated or combined cognitive dysfunction and subtle motor features for incident parkinsonism during follow-up,” they noted.
Approximately half of participants diagnosed with incident parkinsonism during the study period had subtle motor features, cognitive dysfunction, or both, at baseline. Baseline cognitive impairment alone showed a likelihood ratio of 1.76 for development of parkinsonism, but the likelihood ratio was greater when both cognitive impairment and subtle motor findings were present (2.66).
“In individuals who received a diagnosis of both incident dementia and incident parkinsonism, baseline cognitive dysfunction was not associated with incident dementia,” the researchers noted.
The researchers determined that the most likely explanation for the association between cognitive decline and increased Parkinson’s risk was that “low baseline cognitive scores may indicate ongoing cognitive decline in prediagnostic patients who probably will develop parkinsonism, most of whom have prediagnostic PD,” they said.
The study findings were limited by several factors including the potential misclassification of parkinsonism diagnosis, the researchers noted. However, the association between poor cognitive function and the risk of parkinsonism and probably Parkinson’s disease remained for the executive, attention, cognitive speed, and memory domains of cognition, they said. “Our findings suggest that poor cognitive functioning can be considered a prodromal sign of PD,” they concluded.
This study was supported in part by Stichting ParkinsonFonds. The researchers had no financial conflicts to disclose.
FROM JAMA NEUROLOGY
Key clinical point: Mild cognitive impairment may appear early in adults who go on to develop Parkinson’s disease.
Major finding: Poor global cognition at baseline was associated with a greater risk of incident parkinsonism (hazard ratio, 1.79) over approximately 8 years.
Data source: The data come from 7,386 adults in the population-based Rotterdam Study.
Disclosures: This study was supported in part by Stichting ParkinsonFonds. The researchers had no financial conflicts to disclose.
Alopecia patients share their struggles
SILVER SPRING, MD. – Alopecia areata patients struggle as much, if not more so, with the social and emotional challenges of the disease as with the physical challenges, according to patients and others who spoke at a public meeting on alopecia areata patient-focused drug development.
Alopecia areata affects as many as 6.8 million individuals in the United States, according to the National Alopecia Areata Foundation (NAAF). However, the particulars of alopecia can vary widely from one person to another; some patients experience total hair loss (alopecia universalis), while others retain eyebrows, eyelashes, or some body hair.
The FDA meeting, held on Sept. 11, is part of the agency’s patient-focused drug development initiative. “We wanted to hear the broader patient’s voice,” Theresa M. Mullin, PhD, director of the FDA’s Office of Strategic Programs, said in her opening remarks. Gary Sherwood, communications director for NAAF, said that the meeting was the culmination of a 5-year effort, begun in 2012 when alopecia areata was named as one of 39 disease categories under consideration for such a meeting. “It is too early to know what the exact results will be … but if the past is any indication, they may be significant. The meeting held with psoriasis yielded FDA approval of a treatment previously denied,” he added in an interview.
Two panel presentations featured patients who discussed their experiences with alopecia; each was followed by a discussion period where patients and family members in the audience were invited to share their experiences.
The “Health Effects and Daily Impacts” panel allowed several patients and their family members the opportunity to identify specific issues that may surprise clinicians.
“One thing I learned was how much the patients are bothered by sweating of the scalp; this can affect what type of head covering, hair piece, or hat/helmet they are able to wear, and thus limits activities,” Dr. Marathe continued. “This is not something I had focused on previously. I will be more inclined to ask about sweating and offer treatments, such as scalp botulinum toxin or aluminum chloride now that I have been alerted to this concern. Also, the challenges of facial makeup such as pencil for eyebrows was another thing that the FDA session brought home for me; I’m more inclined to suggest things such as microblading for eyebrows, or to try treatments like latanoprost for eyebrows/lashes.”
The second panel, “Current Approaches to Treatment,” included a different group of patients who shared stories of treatments that had been successful and those that had not. “The patients at the FDA meeting expressed very eloquently what our patients feel – different treatments may work temporarily and then stop working, which leads to a roller coaster of emotions of hope and disappointment,” A. Yasmine Kirkorian, MD, also a dermatologist at Children’s National Health System, said in an interview. “Patients and physicians would be interested in a treatment option with a track record for predictable efficacy with durable and sustained hair regrowth and minimal side effects.”
Dr. Marathe noted that in her experience, those who develop alopecia totalis or universalis at a younger age tend to have more recalcitrant disease. “It is still very hard for me to predict which children will regrow their hair spontaneously, or with topical therapies, versus those with more resistant disease. I hope that continued study will allow us to offer a more realistic prognosis for these patients,” she said.
Discussion after the treatment panel included testimonials from patients who reported successful treatment with tofacitinib (Xeljanz), a Janus kinase inhibitor approved for rheumatoid arthritis, which is not approved for treatment of alopecia.
“I absolutely agree with the focus on JAK inhibitors and increasing our understanding of how they work, as well as what some of the long-term effects are,” said Dr. Marathe. “The better we are able to target the pathogenesis of this condition, the more easily we can treat in a more focused fashion and reduce side effects,” but more clinical trials are needed to determine safety and efficacy for children and teens, she noted.
One of her hesitations in prescribing tofacitinib to her patients is that she cannot provide them with a sense of how long they will need to be on the treatment. “Current data show that the hair growth on the medication is usually lost upon stopping it; the question I still struggle with is whether it is realistic to put a 4- or 5-year-old on a medication that has no estimated or anticipated stop date,” she said.
As for what she offers patients in terms of resources for emotional support, Dr. Kirkorian said the psychosocial aspects of alopecia areata are always discussed at patient visits. “Psychosocial needs vary based on age, personality, and personal philosophy. We offer the gamut of outside resources from local support groups, the National Alopecia Areata Foundation, referral to psychology/psychiatry and, very importantly, referral to Camp Discovery. Children have told us across the board how important and meaningful it was to them to be able to just be themselves around other children who look like them.”
Dr. Marathe and Dr. Kirkorian were attendees at the meeting; they had no relevant disclosures. They are members of the Dermatology News Editorial Advisory Board.
SILVER SPRING, MD. – Alopecia areata patients struggle as much, if not more so, with the social and emotional challenges of the disease as with the physical challenges, according to patients and others who spoke at a public meeting on alopecia areata patient-focused drug development.
Alopecia areata affects as many as 6.8 million individuals in the United States, according to the National Alopecia Areata Foundation (NAAF). However, the particulars of alopecia can vary widely from one person to another; some patients experience total hair loss (alopecia universalis), while others retain eyebrows, eyelashes, or some body hair.
The FDA meeting, held on Sept. 11, is part of the agency’s patient-focused drug development initiative. “We wanted to hear the broader patient’s voice,” Theresa M. Mullin, PhD, director of the FDA’s Office of Strategic Programs, said in her opening remarks. Gary Sherwood, communications director for NAAF, said that the meeting was the culmination of a 5-year effort, begun in 2012 when alopecia areata was named as one of 39 disease categories under consideration for such a meeting. “It is too early to know what the exact results will be … but if the past is any indication, they may be significant. The meeting held with psoriasis yielded FDA approval of a treatment previously denied,” he added in an interview.
Two panel presentations featured patients who discussed their experiences with alopecia; each was followed by a discussion period where patients and family members in the audience were invited to share their experiences.
The “Health Effects and Daily Impacts” panel allowed several patients and their family members the opportunity to identify specific issues that may surprise clinicians.
“One thing I learned was how much the patients are bothered by sweating of the scalp; this can affect what type of head covering, hair piece, or hat/helmet they are able to wear, and thus limits activities,” Dr. Marathe continued. “This is not something I had focused on previously. I will be more inclined to ask about sweating and offer treatments, such as scalp botulinum toxin or aluminum chloride now that I have been alerted to this concern. Also, the challenges of facial makeup such as pencil for eyebrows was another thing that the FDA session brought home for me; I’m more inclined to suggest things such as microblading for eyebrows, or to try treatments like latanoprost for eyebrows/lashes.”
The second panel, “Current Approaches to Treatment,” included a different group of patients who shared stories of treatments that had been successful and those that had not. “The patients at the FDA meeting expressed very eloquently what our patients feel – different treatments may work temporarily and then stop working, which leads to a roller coaster of emotions of hope and disappointment,” A. Yasmine Kirkorian, MD, also a dermatologist at Children’s National Health System, said in an interview. “Patients and physicians would be interested in a treatment option with a track record for predictable efficacy with durable and sustained hair regrowth and minimal side effects.”
Dr. Marathe noted that in her experience, those who develop alopecia totalis or universalis at a younger age tend to have more recalcitrant disease. “It is still very hard for me to predict which children will regrow their hair spontaneously, or with topical therapies, versus those with more resistant disease. I hope that continued study will allow us to offer a more realistic prognosis for these patients,” she said.
Discussion after the treatment panel included testimonials from patients who reported successful treatment with tofacitinib (Xeljanz), a Janus kinase inhibitor approved for rheumatoid arthritis, which is not approved for treatment of alopecia.
“I absolutely agree with the focus on JAK inhibitors and increasing our understanding of how they work, as well as what some of the long-term effects are,” said Dr. Marathe. “The better we are able to target the pathogenesis of this condition, the more easily we can treat in a more focused fashion and reduce side effects,” but more clinical trials are needed to determine safety and efficacy for children and teens, she noted.
One of her hesitations in prescribing tofacitinib to her patients is that she cannot provide them with a sense of how long they will need to be on the treatment. “Current data show that the hair growth on the medication is usually lost upon stopping it; the question I still struggle with is whether it is realistic to put a 4- or 5-year-old on a medication that has no estimated or anticipated stop date,” she said.
As for what she offers patients in terms of resources for emotional support, Dr. Kirkorian said the psychosocial aspects of alopecia areata are always discussed at patient visits. “Psychosocial needs vary based on age, personality, and personal philosophy. We offer the gamut of outside resources from local support groups, the National Alopecia Areata Foundation, referral to psychology/psychiatry and, very importantly, referral to Camp Discovery. Children have told us across the board how important and meaningful it was to them to be able to just be themselves around other children who look like them.”
Dr. Marathe and Dr. Kirkorian were attendees at the meeting; they had no relevant disclosures. They are members of the Dermatology News Editorial Advisory Board.
SILVER SPRING, MD. – Alopecia areata patients struggle as much, if not more so, with the social and emotional challenges of the disease as with the physical challenges, according to patients and others who spoke at a public meeting on alopecia areata patient-focused drug development.
Alopecia areata affects as many as 6.8 million individuals in the United States, according to the National Alopecia Areata Foundation (NAAF). However, the particulars of alopecia can vary widely from one person to another; some patients experience total hair loss (alopecia universalis), while others retain eyebrows, eyelashes, or some body hair.
The FDA meeting, held on Sept. 11, is part of the agency’s patient-focused drug development initiative. “We wanted to hear the broader patient’s voice,” Theresa M. Mullin, PhD, director of the FDA’s Office of Strategic Programs, said in her opening remarks. Gary Sherwood, communications director for NAAF, said that the meeting was the culmination of a 5-year effort, begun in 2012 when alopecia areata was named as one of 39 disease categories under consideration for such a meeting. “It is too early to know what the exact results will be … but if the past is any indication, they may be significant. The meeting held with psoriasis yielded FDA approval of a treatment previously denied,” he added in an interview.
Two panel presentations featured patients who discussed their experiences with alopecia; each was followed by a discussion period where patients and family members in the audience were invited to share their experiences.
The “Health Effects and Daily Impacts” panel allowed several patients and their family members the opportunity to identify specific issues that may surprise clinicians.
“One thing I learned was how much the patients are bothered by sweating of the scalp; this can affect what type of head covering, hair piece, or hat/helmet they are able to wear, and thus limits activities,” Dr. Marathe continued. “This is not something I had focused on previously. I will be more inclined to ask about sweating and offer treatments, such as scalp botulinum toxin or aluminum chloride now that I have been alerted to this concern. Also, the challenges of facial makeup such as pencil for eyebrows was another thing that the FDA session brought home for me; I’m more inclined to suggest things such as microblading for eyebrows, or to try treatments like latanoprost for eyebrows/lashes.”
The second panel, “Current Approaches to Treatment,” included a different group of patients who shared stories of treatments that had been successful and those that had not. “The patients at the FDA meeting expressed very eloquently what our patients feel – different treatments may work temporarily and then stop working, which leads to a roller coaster of emotions of hope and disappointment,” A. Yasmine Kirkorian, MD, also a dermatologist at Children’s National Health System, said in an interview. “Patients and physicians would be interested in a treatment option with a track record for predictable efficacy with durable and sustained hair regrowth and minimal side effects.”
Dr. Marathe noted that in her experience, those who develop alopecia totalis or universalis at a younger age tend to have more recalcitrant disease. “It is still very hard for me to predict which children will regrow their hair spontaneously, or with topical therapies, versus those with more resistant disease. I hope that continued study will allow us to offer a more realistic prognosis for these patients,” she said.
Discussion after the treatment panel included testimonials from patients who reported successful treatment with tofacitinib (Xeljanz), a Janus kinase inhibitor approved for rheumatoid arthritis, which is not approved for treatment of alopecia.
“I absolutely agree with the focus on JAK inhibitors and increasing our understanding of how they work, as well as what some of the long-term effects are,” said Dr. Marathe. “The better we are able to target the pathogenesis of this condition, the more easily we can treat in a more focused fashion and reduce side effects,” but more clinical trials are needed to determine safety and efficacy for children and teens, she noted.
One of her hesitations in prescribing tofacitinib to her patients is that she cannot provide them with a sense of how long they will need to be on the treatment. “Current data show that the hair growth on the medication is usually lost upon stopping it; the question I still struggle with is whether it is realistic to put a 4- or 5-year-old on a medication that has no estimated or anticipated stop date,” she said.
As for what she offers patients in terms of resources for emotional support, Dr. Kirkorian said the psychosocial aspects of alopecia areata are always discussed at patient visits. “Psychosocial needs vary based on age, personality, and personal philosophy. We offer the gamut of outside resources from local support groups, the National Alopecia Areata Foundation, referral to psychology/psychiatry and, very importantly, referral to Camp Discovery. Children have told us across the board how important and meaningful it was to them to be able to just be themselves around other children who look like them.”
Dr. Marathe and Dr. Kirkorian were attendees at the meeting; they had no relevant disclosures. They are members of the Dermatology News Editorial Advisory Board.
AT AN FDA PUBLIC MEETING
GERD postop relapse rates highest in women, older adults
Healthy men younger than 45 years have the lowest risk of relapse after reflux surgery compared with other demographic subgroups, according to data from a population-based study of 2,655 adults in Sweden. The findings were published online in JAMA.
“Cohort studies have shown a high risk of recurrent symptoms of GERD after surgery, which may have contributed to the decline in the use of antireflux surgery,” but long-term reflux recurrence rates and potential risk factors have not been well studied, wrote John Maret-Ouda, MD, and colleagues at the Karolinska Institutet in Stockholm, Sweden.
Overall, 18% of the patients suffered a reflux relapse; 84% of these were prescribed long-term medication, and 16% underwent additional surgery.
The highest relapse rates occurred among women, older patients, and those with comorbid conditions. Reflux occurred in 22% of women vs. 14% of men (hazard ratio 1.57), and the hazard ratio was 1.41 for patients aged 61 years and older compared with those aged 45 years and younger. Patients with one or more comorbidities were approximately one-third more likely to have a recurrence of reflux, compared with those who had no comorbidities (hazard ratio 1.36).
Approximately 4% of patients reported complications; the most common complication was infection (1.1%), followed by bleeding (0.9%), and esophageal perforation (0.9%).
The recurrence rate of 18% is low compared with other studies, the researchers noted. Possible reasons for the difference include the population-based design of the current study, which meant that no patients were lost to follow-up, as well as the recent time period, “in which laparoscopic antireflux surgery has become more centralized to expert centers where selection of patients might be stricter and the quality of surgery might be higher,” they wrote.
The study findings were limited by several factors including clinical variations on coding, lack of data on certain confounding variables including body mass index and smoking, and a lack of control GERD patients who did not undergo antireflux surgery, the researchers said. The results suggest that the benefits of laparoscopic antireflux surgery may be diminished by the potential for recurrent GERD, they added.
The Swedish Research Council funded the study. The researchers had no financial conflicts to disclose.
“The operation can be performed with a relatively low rate of morbidity and a very low mortality rate,” Stuart J. Spechler, MD, wrote in an editorial. “Although findings regarding GERD symptom relief and patient satisfaction based on medication usage data should be interpreted with caution, the observation that more than 80% of patients did not restart antireflux medications after laparoscopic antireflux surgery suggests that the operation provided long-lasting relief of GERD symptoms for most patients,” he said. Although surgery is not a permanent cure for all patients with GERD, “the ever-increasing number of proposed [proton pump inhibitor] risks has caused the greatest concern among clinicians and their patients,” said Dr. Spechler. “Whether the greater than 80% possibility of long-term freedom from PPIs and their associated risks warrants the 4% risk of acute surgical complications and the 17.7% risk of GERD recurrence is a decision that individual patients should make after a detailed discussion of these risks and benefits with their physicians,” he said. However, the study findings suggest “that laparoscopic antireflux surgery might be an especially appealing option for young and otherwise healthy men, who seem to have the lowest rate of GERD recurrence after antireflux surgery and who otherwise would likely require decades of PPI treatment without the operation,” he wrote (JAMA 2017;318:913-5).
Dr. Spechler is affiliated with Baylor University in Dallas. He disclosed serving as a consultant for Ironwood Pharmaceuticals and Takeda Pharmaceuticals, and funding support from the National Institutes of Health.
“The operation can be performed with a relatively low rate of morbidity and a very low mortality rate,” Stuart J. Spechler, MD, wrote in an editorial. “Although findings regarding GERD symptom relief and patient satisfaction based on medication usage data should be interpreted with caution, the observation that more than 80% of patients did not restart antireflux medications after laparoscopic antireflux surgery suggests that the operation provided long-lasting relief of GERD symptoms for most patients,” he said. Although surgery is not a permanent cure for all patients with GERD, “the ever-increasing number of proposed [proton pump inhibitor] risks has caused the greatest concern among clinicians and their patients,” said Dr. Spechler. “Whether the greater than 80% possibility of long-term freedom from PPIs and their associated risks warrants the 4% risk of acute surgical complications and the 17.7% risk of GERD recurrence is a decision that individual patients should make after a detailed discussion of these risks and benefits with their physicians,” he said. However, the study findings suggest “that laparoscopic antireflux surgery might be an especially appealing option for young and otherwise healthy men, who seem to have the lowest rate of GERD recurrence after antireflux surgery and who otherwise would likely require decades of PPI treatment without the operation,” he wrote (JAMA 2017;318:913-5).
Dr. Spechler is affiliated with Baylor University in Dallas. He disclosed serving as a consultant for Ironwood Pharmaceuticals and Takeda Pharmaceuticals, and funding support from the National Institutes of Health.
“The operation can be performed with a relatively low rate of morbidity and a very low mortality rate,” Stuart J. Spechler, MD, wrote in an editorial. “Although findings regarding GERD symptom relief and patient satisfaction based on medication usage data should be interpreted with caution, the observation that more than 80% of patients did not restart antireflux medications after laparoscopic antireflux surgery suggests that the operation provided long-lasting relief of GERD symptoms for most patients,” he said. Although surgery is not a permanent cure for all patients with GERD, “the ever-increasing number of proposed [proton pump inhibitor] risks has caused the greatest concern among clinicians and their patients,” said Dr. Spechler. “Whether the greater than 80% possibility of long-term freedom from PPIs and their associated risks warrants the 4% risk of acute surgical complications and the 17.7% risk of GERD recurrence is a decision that individual patients should make after a detailed discussion of these risks and benefits with their physicians,” he said. However, the study findings suggest “that laparoscopic antireflux surgery might be an especially appealing option for young and otherwise healthy men, who seem to have the lowest rate of GERD recurrence after antireflux surgery and who otherwise would likely require decades of PPI treatment without the operation,” he wrote (JAMA 2017;318:913-5).
Dr. Spechler is affiliated with Baylor University in Dallas. He disclosed serving as a consultant for Ironwood Pharmaceuticals and Takeda Pharmaceuticals, and funding support from the National Institutes of Health.
Healthy men younger than 45 years have the lowest risk of relapse after reflux surgery compared with other demographic subgroups, according to data from a population-based study of 2,655 adults in Sweden. The findings were published online in JAMA.
“Cohort studies have shown a high risk of recurrent symptoms of GERD after surgery, which may have contributed to the decline in the use of antireflux surgery,” but long-term reflux recurrence rates and potential risk factors have not been well studied, wrote John Maret-Ouda, MD, and colleagues at the Karolinska Institutet in Stockholm, Sweden.
Overall, 18% of the patients suffered a reflux relapse; 84% of these were prescribed long-term medication, and 16% underwent additional surgery.
The highest relapse rates occurred among women, older patients, and those with comorbid conditions. Reflux occurred in 22% of women vs. 14% of men (hazard ratio 1.57), and the hazard ratio was 1.41 for patients aged 61 years and older compared with those aged 45 years and younger. Patients with one or more comorbidities were approximately one-third more likely to have a recurrence of reflux, compared with those who had no comorbidities (hazard ratio 1.36).
Approximately 4% of patients reported complications; the most common complication was infection (1.1%), followed by bleeding (0.9%), and esophageal perforation (0.9%).
The recurrence rate of 18% is low compared with other studies, the researchers noted. Possible reasons for the difference include the population-based design of the current study, which meant that no patients were lost to follow-up, as well as the recent time period, “in which laparoscopic antireflux surgery has become more centralized to expert centers where selection of patients might be stricter and the quality of surgery might be higher,” they wrote.
The study findings were limited by several factors including clinical variations on coding, lack of data on certain confounding variables including body mass index and smoking, and a lack of control GERD patients who did not undergo antireflux surgery, the researchers said. The results suggest that the benefits of laparoscopic antireflux surgery may be diminished by the potential for recurrent GERD, they added.
The Swedish Research Council funded the study. The researchers had no financial conflicts to disclose.
Healthy men younger than 45 years have the lowest risk of relapse after reflux surgery compared with other demographic subgroups, according to data from a population-based study of 2,655 adults in Sweden. The findings were published online in JAMA.
“Cohort studies have shown a high risk of recurrent symptoms of GERD after surgery, which may have contributed to the decline in the use of antireflux surgery,” but long-term reflux recurrence rates and potential risk factors have not been well studied, wrote John Maret-Ouda, MD, and colleagues at the Karolinska Institutet in Stockholm, Sweden.
Overall, 18% of the patients suffered a reflux relapse; 84% of these were prescribed long-term medication, and 16% underwent additional surgery.
The highest relapse rates occurred among women, older patients, and those with comorbid conditions. Reflux occurred in 22% of women vs. 14% of men (hazard ratio 1.57), and the hazard ratio was 1.41 for patients aged 61 years and older compared with those aged 45 years and younger. Patients with one or more comorbidities were approximately one-third more likely to have a recurrence of reflux, compared with those who had no comorbidities (hazard ratio 1.36).
Approximately 4% of patients reported complications; the most common complication was infection (1.1%), followed by bleeding (0.9%), and esophageal perforation (0.9%).
The recurrence rate of 18% is low compared with other studies, the researchers noted. Possible reasons for the difference include the population-based design of the current study, which meant that no patients were lost to follow-up, as well as the recent time period, “in which laparoscopic antireflux surgery has become more centralized to expert centers where selection of patients might be stricter and the quality of surgery might be higher,” they wrote.
The study findings were limited by several factors including clinical variations on coding, lack of data on certain confounding variables including body mass index and smoking, and a lack of control GERD patients who did not undergo antireflux surgery, the researchers said. The results suggest that the benefits of laparoscopic antireflux surgery may be diminished by the potential for recurrent GERD, they added.
The Swedish Research Council funded the study. The researchers had no financial conflicts to disclose.
FROM JAMA
Key clinical point: Young men were less likely than were other demographic groups to experience recurrence of gastroesophageal reflux after surgery.
Major finding: Overall, 18% of 2,655 adults who underwent reflux surgery experienced recurrent reflux requiring long-term medication or additional surgery.
Data source: A population-based, retrospective cohort study of reflux surgery patients in Sweden.
Disclosures: The Swedish Research Council supported the study.
VIDEO: Alopecia areata patients seek emotional support
SILVER SPRING, MD. – The emotional challenges facing alopecia areata patients are as tough, or tougher, than the physical challenges, according to many patients participating in a public meeting on alopecia areata patient-focused drug development.
A panel of patients shared their experiences of living with alopecia areata, including Elizabeth DeCarlo of Wilmington, Delaware. In a video interview at the meeting, held at FDA headquarters on Sept. 11, Ms. DeCarlo elaborated on what she would like clinicians to understand about alopecia patients that might surprise them, and what matters to her as a patient.
“I would tell them to be more compassionate,” Ms. DeCarlo said. “It’s very emotional.” She also emphasized the value of giving alopecia patients information about local support groups, as well as national organizations such as the National Alopecia Areata Foundation.
Ms. DeCarlo had no financial conflicts to disclose.
SILVER SPRING, MD. – The emotional challenges facing alopecia areata patients are as tough, or tougher, than the physical challenges, according to many patients participating in a public meeting on alopecia areata patient-focused drug development.
A panel of patients shared their experiences of living with alopecia areata, including Elizabeth DeCarlo of Wilmington, Delaware. In a video interview at the meeting, held at FDA headquarters on Sept. 11, Ms. DeCarlo elaborated on what she would like clinicians to understand about alopecia patients that might surprise them, and what matters to her as a patient.
“I would tell them to be more compassionate,” Ms. DeCarlo said. “It’s very emotional.” She also emphasized the value of giving alopecia patients information about local support groups, as well as national organizations such as the National Alopecia Areata Foundation.
Ms. DeCarlo had no financial conflicts to disclose.
SILVER SPRING, MD. – The emotional challenges facing alopecia areata patients are as tough, or tougher, than the physical challenges, according to many patients participating in a public meeting on alopecia areata patient-focused drug development.
A panel of patients shared their experiences of living with alopecia areata, including Elizabeth DeCarlo of Wilmington, Delaware. In a video interview at the meeting, held at FDA headquarters on Sept. 11, Ms. DeCarlo elaborated on what she would like clinicians to understand about alopecia patients that might surprise them, and what matters to her as a patient.
“I would tell them to be more compassionate,” Ms. DeCarlo said. “It’s very emotional.” She also emphasized the value of giving alopecia patients information about local support groups, as well as national organizations such as the National Alopecia Areata Foundation.
Ms. DeCarlo had no financial conflicts to disclose.
AT AN FDA PUBLIC MEETING
USPSTF backs away from cotesting in cervical cancer screening
Women aged 30-65 years should be offered a choice between two cervical cancer screening methods, according to draft recommendations from the U.S. Preventive Services Task Force. The recommendations were released on Sept. 12.
The Task Force continues to recommend that women in their 20s be screened every 3 years via cervical cytology, but in a change from the 2012 recommendations, the researchers now advise clinicians to offer women aged 30-65 years a choice of either cytology every 3 years or the high-risk human papillomavirus (hrHPV) test every 5 years as a method of screening for cervical cancer. Cotesting is no longer recommended.
Offering women aged 30-65 years a screening choice received an A recommendation. The draft retains the previous Task Force position and D recommendation against cervical cancer screening for certain groups, including women younger than 21 years, women aged 65 and older with a history of screening and a low risk of cervical cancer, and women who have had a hysterectomy.
The USPSTF based the draft recommendations in part on a review of four randomized, controlled trials of cotesting hrHPV and cytology that included more than 130,000 women.
“Modeling found that cotesting does not offer any benefit in terms of cancer reduction or life-years gained over hrHPV testing alone but increases the number of tests and procedures per each cancer case averted,” the Task Force members noted in the draft recommendation statement. “Therefore, the USPSTF concluded that there is convincing evidence that screening with either cytology alone or hrHPV testing alone provides substantial benefit and is preferable to cotesting” in otherwise healthy women aged 30-65 years.
The American College of Obstetricians and Gynecologists currently recommends cotesting with cytology and HPV testing every 5 years or cytology alone every 3 years in women aged 30-65 years (Obstet Gynecol. 2016;128[4]:e111-30).
The USPSTF draft recommendations do not apply to women at increased risk for cervical cancer, including those with compromised immune systems or those who have cervical intraepithelial neoplasia grade 2 or 3.
The draft recommendations are available online for public comment from Sept. 12 through Oct. 9, 2017, at the USPSTF website, www.uspreventiveservicestaskforce.org.
Women aged 30-65 years should be offered a choice between two cervical cancer screening methods, according to draft recommendations from the U.S. Preventive Services Task Force. The recommendations were released on Sept. 12.
The Task Force continues to recommend that women in their 20s be screened every 3 years via cervical cytology, but in a change from the 2012 recommendations, the researchers now advise clinicians to offer women aged 30-65 years a choice of either cytology every 3 years or the high-risk human papillomavirus (hrHPV) test every 5 years as a method of screening for cervical cancer. Cotesting is no longer recommended.
Offering women aged 30-65 years a screening choice received an A recommendation. The draft retains the previous Task Force position and D recommendation against cervical cancer screening for certain groups, including women younger than 21 years, women aged 65 and older with a history of screening and a low risk of cervical cancer, and women who have had a hysterectomy.
The USPSTF based the draft recommendations in part on a review of four randomized, controlled trials of cotesting hrHPV and cytology that included more than 130,000 women.
“Modeling found that cotesting does not offer any benefit in terms of cancer reduction or life-years gained over hrHPV testing alone but increases the number of tests and procedures per each cancer case averted,” the Task Force members noted in the draft recommendation statement. “Therefore, the USPSTF concluded that there is convincing evidence that screening with either cytology alone or hrHPV testing alone provides substantial benefit and is preferable to cotesting” in otherwise healthy women aged 30-65 years.
The American College of Obstetricians and Gynecologists currently recommends cotesting with cytology and HPV testing every 5 years or cytology alone every 3 years in women aged 30-65 years (Obstet Gynecol. 2016;128[4]:e111-30).
The USPSTF draft recommendations do not apply to women at increased risk for cervical cancer, including those with compromised immune systems or those who have cervical intraepithelial neoplasia grade 2 or 3.
The draft recommendations are available online for public comment from Sept. 12 through Oct. 9, 2017, at the USPSTF website, www.uspreventiveservicestaskforce.org.
Women aged 30-65 years should be offered a choice between two cervical cancer screening methods, according to draft recommendations from the U.S. Preventive Services Task Force. The recommendations were released on Sept. 12.
The Task Force continues to recommend that women in their 20s be screened every 3 years via cervical cytology, but in a change from the 2012 recommendations, the researchers now advise clinicians to offer women aged 30-65 years a choice of either cytology every 3 years or the high-risk human papillomavirus (hrHPV) test every 5 years as a method of screening for cervical cancer. Cotesting is no longer recommended.
Offering women aged 30-65 years a screening choice received an A recommendation. The draft retains the previous Task Force position and D recommendation against cervical cancer screening for certain groups, including women younger than 21 years, women aged 65 and older with a history of screening and a low risk of cervical cancer, and women who have had a hysterectomy.
The USPSTF based the draft recommendations in part on a review of four randomized, controlled trials of cotesting hrHPV and cytology that included more than 130,000 women.
“Modeling found that cotesting does not offer any benefit in terms of cancer reduction or life-years gained over hrHPV testing alone but increases the number of tests and procedures per each cancer case averted,” the Task Force members noted in the draft recommendation statement. “Therefore, the USPSTF concluded that there is convincing evidence that screening with either cytology alone or hrHPV testing alone provides substantial benefit and is preferable to cotesting” in otherwise healthy women aged 30-65 years.
The American College of Obstetricians and Gynecologists currently recommends cotesting with cytology and HPV testing every 5 years or cytology alone every 3 years in women aged 30-65 years (Obstet Gynecol. 2016;128[4]:e111-30).
The USPSTF draft recommendations do not apply to women at increased risk for cervical cancer, including those with compromised immune systems or those who have cervical intraepithelial neoplasia grade 2 or 3.
The draft recommendations are available online for public comment from Sept. 12 through Oct. 9, 2017, at the USPSTF website, www.uspreventiveservicestaskforce.org.