Sherry Boschert

SAN FRANCISCO – Treating a new diagnosis of severe sepsis or septic shock with a combination of moxifloxacin and meropenem did not decrease the risk of sepsis-related organ dysfunction, compared with meropenem monotherapy, in a randomized, open-label trial.

On the contrary, there were statistical hints suggesting that the monotherapy regimen may be safer than the dual-drug strategy, Dr. Tobias Welte and his associates reported at an international conference of the American Thoracic Society.

Mean daily scores on the SOFA (Sequential Organ Failure Assessment) for 551 patients with evaluable data did not differ significantly between groups (a score of 8 in both) during treatment for 7-14 days or until discharge from the ICU or death, said Dr. Welte of Hannover (Germany) Medical School. Subscores on the SOFA for cardiovascular, respiratory, coagulation, renal, or hepatic failure also were similar between groups.

Among secondary outcomes, mortality rates at 28 days were 24% with the combination therapy and 22% with monotherapy. Mortality rates at 90 days were 35% with combination therapy and 32% with monotherapy. Those differences between groups were not significant, he said.

The combination therapy group had a significantly higher rate of treatment-related adverse events (9%), compared with the monotherapy group (4%).

The study was published online on May 21 in JAMA (doi:10.1001/jama.2012.5833).

The investigators had expected that the combination regimen would improve clinical outcomes. Use of empirical therapy with combined antibiotics has been controversial and is more common in the United States than in Europe.

Germany has a relatively low rate of antibiotic-resistant organisms, and the study had a relatively low rate of drug resistance. In patients with a first episode of severe sepsis or septic shock without risk factors for resistance to multiple antibiotics, monotherapy with a drug like meropenem is a good choice, Dr. Welte said.

"What we need for the future is a better characterization of patients who are at risk for multiresistant organisms," he said. "If you do it like the Americans do it, every patient is at risk for multiresistancy."He said he believes that with more precise risk stratification, more than half of U.S. patients with severe sepsis or septic shock might be candidates for monotherapy. Both groups averaged 8 days of treatment, showing that "8 days of treatment are enough even in patients with severe sepsis or septic shock," Dr. Welte said. One of the reasons for increased rates of multidrug-resistant organisms in the United States is overuse of antibiotics, he added. If treatment for severe sepsis were limited to one drug for only 7-8 days in areas with low rates of resistance, drug use in these cases could be reduced twofold, he suggested.

The MaxSep (Treatment of Severe Sepsis and Septic Shock) study included patients from 44 ICUs in Germany between October 2007 and March 2010. Intravenous infusions delivered 1-g meropenem every 8 hours plus moxifloxacin 400 mg every 24 hours, or meropenem alone. Survivors were followed for 90 days.

Baseline characteristics were similar between groups. After treatment, the results were similar between groups in ICU or hospital length of stay, median intervention-free days, and rate of secondary infection.

Notably, half of the infections were community acquired, which adds to the generalizability of the findings, Dr. Welte said.

In previous retrospective cohort studies, survival in severe sepsis significantly improved with a combination of beta-lactam antibiotics plus aminoglycosides, fluoroquinolones, macrolides, or clindamycin, compared with monotherapy (Crit. Care Med. 2010;38:1651-64).

Dr. Frank M. Brunkhorst of Friedrich Schiller University Jena (Germany) was the lead investigator in the study.

The study was funded by German government ministries and foundations. AstraZeneca and Bayer HealthCare provided the drugs for the study. Dr. Welte reported financial relationships with AstraZeneca, Bayer HealthCare, Astellas, GlaxoSmithKline, Novartis, and Pfizer. Some of his associates in the study reported relationships with these and other pharmaceutical companies.

SAN FRANCISCO – Treating a new diagnosis of severe sepsis or septic shock with a combination of moxifloxacin and meropenem did not decrease the risk of sepsis-related organ dysfunction, compared with meropenem monotherapy, in a randomized, open-label trial.

On the contrary, there were statistical hints suggesting that the monotherapy regimen may be safer than the dual-drug strategy, Dr. Tobias Welte and his associates reported at an international conference of the American Thoracic Society.

Mean daily scores on the SOFA (Sequential Organ Failure Assessment) for 551 patients with evaluable data did not differ significantly between groups (a score of 8 in both) during treatment for 7-14 days or until discharge from the ICU or death, said Dr. Welte of Hannover (Germany) Medical School. Subscores on the SOFA for cardiovascular, respiratory, coagulation, renal, or hepatic failure also were similar between groups.

Among secondary outcomes, mortality rates at 28 days were 24% with the combination therapy and 22% with monotherapy. Mortality rates at 90 days were 35% with combination therapy and 32% with monotherapy. Those differences between groups were not significant, he said.

The combination therapy group had a significantly higher rate of treatment-related adverse events (9%), compared with the monotherapy group (4%).

The study was published online on May 21 in JAMA (doi:10.1001/jama.2012.5833).

The investigators had expected that the combination regimen would improve clinical outcomes. Use of empirical therapy with combined antibiotics has been controversial and is more common in the United States than in Europe.

Germany has a relatively low rate of antibiotic-resistant organisms, and the study had a relatively low rate of drug resistance. In patients with a first episode of severe sepsis or septic shock without risk factors for resistance to multiple antibiotics, monotherapy with a drug like meropenem is a good choice, Dr. Welte said.

"What we need for the future is a better characterization of patients who are at risk for multiresistant organisms," he said. "If you do it like the Americans do it, every patient is at risk for multiresistancy."He said he believes that with more precise risk stratification, more than half of U.S. patients with severe sepsis or septic shock might be candidates for monotherapy. Both groups averaged 8 days of treatment, showing that "8 days of treatment are enough even in patients with severe sepsis or septic shock," Dr. Welte said. One of the reasons for increased rates of multidrug-resistant organisms in the United States is overuse of antibiotics, he added. If treatment for severe sepsis were limited to one drug for only 7-8 days in areas with low rates of resistance, drug use in these cases could be reduced twofold, he suggested.

The MaxSep (Treatment of Severe Sepsis and Septic Shock) study included patients from 44 ICUs in Germany between October 2007 and March 2010. Intravenous infusions delivered 1-g meropenem every 8 hours plus moxifloxacin 400 mg every 24 hours, or meropenem alone. Survivors were followed for 90 days.

Baseline characteristics were similar between groups. After treatment, the results were similar between groups in ICU or hospital length of stay, median intervention-free days, and rate of secondary infection.

Notably, half of the infections were community acquired, which adds to the generalizability of the findings, Dr. Welte said.

In previous retrospective cohort studies, survival in severe sepsis significantly improved with a combination of beta-lactam antibiotics plus aminoglycosides, fluoroquinolones, macrolides, or clindamycin, compared with monotherapy (Crit. Care Med. 2010;38:1651-64).

Dr. Frank M. Brunkhorst of Friedrich Schiller University Jena (Germany) was the lead investigator in the study.

The study was funded by German government ministries and foundations. AstraZeneca and Bayer HealthCare provided the drugs for the study. Dr. Welte reported financial relationships with AstraZeneca, Bayer HealthCare, Astellas, GlaxoSmithKline, Novartis, and Pfizer. Some of his associates in the study reported relationships with these and other pharmaceutical companies.

SAN FRANCISCO – Treating a new diagnosis of severe sepsis or septic shock with a combination of moxifloxacin and meropenem did not decrease the risk of sepsis-related organ dysfunction, compared with meropenem monotherapy, in a randomized, open-label trial.

On the contrary, there were statistical hints suggesting that the monotherapy regimen may be safer than the dual-drug strategy, Dr. Tobias Welte and his associates reported at an international conference of the American Thoracic Society.

Mean daily scores on the SOFA (Sequential Organ Failure Assessment) for 551 patients with evaluable data did not differ significantly between groups (a score of 8 in both) during treatment for 7-14 days or until discharge from the ICU or death, said Dr. Welte of Hannover (Germany) Medical School. Subscores on the SOFA for cardiovascular, respiratory, coagulation, renal, or hepatic failure also were similar between groups.

Among secondary outcomes, mortality rates at 28 days were 24% with the combination therapy and 22% with monotherapy. Mortality rates at 90 days were 35% with combination therapy and 32% with monotherapy. Those differences between groups were not significant, he said.

The combination therapy group had a significantly higher rate of treatment-related adverse events (9%), compared with the monotherapy group (4%).

The study was published online on May 21 in JAMA (doi:10.1001/jama.2012.5833).

The investigators had expected that the combination regimen would improve clinical outcomes. Use of empirical therapy with combined antibiotics has been controversial and is more common in the United States than in Europe.

Germany has a relatively low rate of antibiotic-resistant organisms, and the study had a relatively low rate of drug resistance. In patients with a first episode of severe sepsis or septic shock without risk factors for resistance to multiple antibiotics, monotherapy with a drug like meropenem is a good choice, Dr. Welte said.

"What we need for the future is a better characterization of patients who are at risk for multiresistant organisms," he said. "If you do it like the Americans do it, every patient is at risk for multiresistancy."He said he believes that with more precise risk stratification, more than half of U.S. patients with severe sepsis or septic shock might be candidates for monotherapy. Both groups averaged 8 days of treatment, showing that "8 days of treatment are enough even in patients with severe sepsis or septic shock," Dr. Welte said. One of the reasons for increased rates of multidrug-resistant organisms in the United States is overuse of antibiotics, he added. If treatment for severe sepsis were limited to one drug for only 7-8 days in areas with low rates of resistance, drug use in these cases could be reduced twofold, he suggested.

The MaxSep (Treatment of Severe Sepsis and Septic Shock) study included patients from 44 ICUs in Germany between October 2007 and March 2010. Intravenous infusions delivered 1-g meropenem every 8 hours plus moxifloxacin 400 mg every 24 hours, or meropenem alone. Survivors were followed for 90 days.

Baseline characteristics were similar between groups. After treatment, the results were similar between groups in ICU or hospital length of stay, median intervention-free days, and rate of secondary infection.

Notably, half of the infections were community acquired, which adds to the generalizability of the findings, Dr. Welte said.

In previous retrospective cohort studies, survival in severe sepsis significantly improved with a combination of beta-lactam antibiotics plus aminoglycosides, fluoroquinolones, macrolides, or clindamycin, compared with monotherapy (Crit. Care Med. 2010;38:1651-64).

Dr. Frank M. Brunkhorst of Friedrich Schiller University Jena (Germany) was the lead investigator in the study.

The study was funded by German government ministries and foundations. AstraZeneca and Bayer HealthCare provided the drugs for the study. Dr. Welte reported financial relationships with AstraZeneca, Bayer HealthCare, Astellas, GlaxoSmithKline, Novartis, and Pfizer. Some of his associates in the study reported relationships with these and other pharmaceutical companies.

SAN FRANCISCO – A proposed new definition of acute respiratory distress syndrome describes categories based on mild, moderate, or severe hypoxemia that correlate increasing severity with significantly increased mortality or increased time on mechanical ventilation among survivors.

The draft definition, created under consensus process by an international panel of experts, was refined by empirical testing in a meta-analysis of data on 4,457 patients in two large data sets from seven centers. The risk of mortality from acute respiratory distress syndrome (ARDS) was 27% with mild disease, 32% with moderate ARDS, and 45% with severe ARDS, Dr. Niall D. Ferguson and Dr. Gordon D. Rubenfeld reported at an international conference of the American Thoracic Society.

Sherry Boschert/IMNG Medical Media

The median duration of mechanical ventilation in survivors was 5 days in patients with mild ARDS, 7 days with moderate ARDS, and 9 days with severe ARDS, said Dr. Ferguson, director of critical care medicine at the University of Toronto. The study was published online May 21 in JAMA (doi: 10.1001/jama.2012.5669).

The European Society of Intensive Care Medicine convened the panel of experts in Berlin in 2011 to draft a new definition of ARDS in hopes of improving upon the 1994 definition from the American-European Consensus Conference (AECC), said Dr. Rubenfeld, professor of medicine at the University of Toronto and chief of the program in trauma/emergency and critical care at Sunnybrook Health Sciences Center, Toronto. Since the AECC definition was adopted widely, issues of reliability and validity have emerged. The American Thoracic Society and the Society of Critical Care Medicine endorsed the 2011 consensus effort.

Under the new Berlin Definition, patients with mild ARDS have mild hypoxemia, defined as a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen of 201-300 mm Hg (PaO₂/FIO₂ = 201-300 mm Hg). Moderate hypoxia (PaO₂/FIO₂ = 101-200 mm Hg) defines moderate ARDS, and severe hypoxia (PaO₂/FIO₂ = 100 mm Hg or less) defines severe ARDS.

The initial draft of the Berlin Definition included four ancillary variables for severe ARDS that were dropped after the meta-analysis found that they did not improve the predictive value for mortality, the speakers and their associates in the study reported. The abandoned variables were radiographic severity, respiratory system compliance, positive end-expiratory pressure, and corrected expired volume per minute.

Dr. Rubenfeld stressed that these variables still are important for clinicians to measure and for understanding ARDS, but they were not included in the definition of severe ARDS because they made the definition more complex while not adding anything to the predictive value of the definition.

He also cautioned that neither the Berlin Definition nor the AECC definition is designed to be a prognostic model; the end point of mortality was used to hone the Berlin Definition.

The Berlin Definition had better predictive validity for mortality than the AECC definition in an analysis using the area under the receiver operating curve (AUROC) in logistic regression models. The Berlin Definition had an AUROC of 0.577, compared with 0.536 for the AECC definition, a statistically significant improvement.

The data for the meta-analysis came from four multicenter clinical studies and three single-center physiological studies, the investigators reported.

Twenty-two percent of patients met the Berlin Definition criteria for mild ARDS, 50% had moderate ARDS, and 28% had severe ARDS. Median ventilator-free days declined with severity of disease, from 20 days with mild ARDS to 16 days with moderate ARDS and 1 day with severe ARDS.

Among patients with mild ARDS at baseline under the Berlin Definition, 29% progressed to moderate disease and 4% progressed to severe disease within 7 days. Among patients with moderate ARDS at baseline, 13% progressed to severe disease within 7 days.

Sherry Boschert/IMNG Medical Media

The investigators suggested that this approach of combining consensus discussions with empirical evaluation might be a model for creating more accurate, evidence-based definitions for critical illness syndromes. Previous ARDS definitions relied on expert consensus alone.

Without the empirical evaluation that led to deleting the ancillary variables, a needlessly complex ARDS definition would have been proposed, Dr. Rubenfeld said.

The study was sponsored by the European Society of Intensive Care Medicine, the National Institutes of Health, and the Canadian Institutes of Health Research (CIHR). CareFusion provided in-kind support for the study. Dr. Ferguson was supported by a CIHR New Investigator Award. Dr. Rubenfeld reported having financial relationships with Ikaria, Faron, and Cerus. Some of his associates in the study reported financial relationships with Maquet Medical, Hemodec, Faron, AstraZeneca, U.S. Biotest, Sirius Genetics, Sanofi-Aventis, Immunetrics, Abbott, Eli Lilly, Ikaria, GlaxoSmithKline, Tarix, Apeiron, and/or Novalung.

The Berlin Definition of ARDS

• Timing: Within 1 week of a known clinical insult or new or worsening respiratory symptoms.

• Chest imaging: Bilateral opacities on x-ray or CT scan not fully explained by effusions, lobar/lung collapse, or nodules.

• Origin of edema: Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present.

• Oxygenation:

Mild: PaO₂/FIO₂ of 201-300 mm Hg with positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) of 5 cm H₂O or greater.

Moderate: PaO₂/FIO₂ of 101-200 mm Hg with PEEP of 5 cm H₂O or greater.

Severe: PaO₂/FIO₂ of 100 mm Hg or less with PEEP of 5 cm H₂O or greater.

If the altitude is higher than 1,000 m, the correction factor should be calculated as PaO₂/RO₂ × (barometric pressure/760).

SAN FRANCISCO – A proposed new definition of acute respiratory distress syndrome describes categories based on mild, moderate, or severe hypoxemia that correlate increasing severity with significantly increased mortality or increased time on mechanical ventilation among survivors.

The draft definition, created under consensus process by an international panel of experts, was refined by empirical testing in a meta-analysis of data on 4,457 patients in two large data sets from seven centers. The risk of mortality from acute respiratory distress syndrome (ARDS) was 27% with mild disease, 32% with moderate ARDS, and 45% with severe ARDS, Dr. Niall D. Ferguson and Dr. Gordon D. Rubenfeld reported at an international conference of the American Thoracic Society.

Sherry Boschert/IMNG Medical Media

The median duration of mechanical ventilation in survivors was 5 days in patients with mild ARDS, 7 days with moderate ARDS, and 9 days with severe ARDS, said Dr. Ferguson, director of critical care medicine at the University of Toronto. The study was published online May 21 in JAMA (doi: 10.1001/jama.2012.5669).

The European Society of Intensive Care Medicine convened the panel of experts in Berlin in 2011 to draft a new definition of ARDS in hopes of improving upon the 1994 definition from the American-European Consensus Conference (AECC), said Dr. Rubenfeld, professor of medicine at the University of Toronto and chief of the program in trauma/emergency and critical care at Sunnybrook Health Sciences Center, Toronto. Since the AECC definition was adopted widely, issues of reliability and validity have emerged. The American Thoracic Society and the Society of Critical Care Medicine endorsed the 2011 consensus effort.

Under the new Berlin Definition, patients with mild ARDS have mild hypoxemia, defined as a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen of 201-300 mm Hg (PaO₂/FIO₂ = 201-300 mm Hg). Moderate hypoxia (PaO₂/FIO₂ = 101-200 mm Hg) defines moderate ARDS, and severe hypoxia (PaO₂/FIO₂ = 100 mm Hg or less) defines severe ARDS.

The initial draft of the Berlin Definition included four ancillary variables for severe ARDS that were dropped after the meta-analysis found that they did not improve the predictive value for mortality, the speakers and their associates in the study reported. The abandoned variables were radiographic severity, respiratory system compliance, positive end-expiratory pressure, and corrected expired volume per minute.

Dr. Rubenfeld stressed that these variables still are important for clinicians to measure and for understanding ARDS, but they were not included in the definition of severe ARDS because they made the definition more complex while not adding anything to the predictive value of the definition.

He also cautioned that neither the Berlin Definition nor the AECC definition is designed to be a prognostic model; the end point of mortality was used to hone the Berlin Definition.

The Berlin Definition had better predictive validity for mortality than the AECC definition in an analysis using the area under the receiver operating curve (AUROC) in logistic regression models. The Berlin Definition had an AUROC of 0.577, compared with 0.536 for the AECC definition, a statistically significant improvement.

The data for the meta-analysis came from four multicenter clinical studies and three single-center physiological studies, the investigators reported.

Twenty-two percent of patients met the Berlin Definition criteria for mild ARDS, 50% had moderate ARDS, and 28% had severe ARDS. Median ventilator-free days declined with severity of disease, from 20 days with mild ARDS to 16 days with moderate ARDS and 1 day with severe ARDS.

Among patients with mild ARDS at baseline under the Berlin Definition, 29% progressed to moderate disease and 4% progressed to severe disease within 7 days. Among patients with moderate ARDS at baseline, 13% progressed to severe disease within 7 days.

Sherry Boschert/IMNG Medical Media

The investigators suggested that this approach of combining consensus discussions with empirical evaluation might be a model for creating more accurate, evidence-based definitions for critical illness syndromes. Previous ARDS definitions relied on expert consensus alone.

Without the empirical evaluation that led to deleting the ancillary variables, a needlessly complex ARDS definition would have been proposed, Dr. Rubenfeld said.

The study was sponsored by the European Society of Intensive Care Medicine, the National Institutes of Health, and the Canadian Institutes of Health Research (CIHR). CareFusion provided in-kind support for the study. Dr. Ferguson was supported by a CIHR New Investigator Award. Dr. Rubenfeld reported having financial relationships with Ikaria, Faron, and Cerus. Some of his associates in the study reported financial relationships with Maquet Medical, Hemodec, Faron, AstraZeneca, U.S. Biotest, Sirius Genetics, Sanofi-Aventis, Immunetrics, Abbott, Eli Lilly, Ikaria, GlaxoSmithKline, Tarix, Apeiron, and/or Novalung.

The Berlin Definition of ARDS

• Timing: Within 1 week of a known clinical insult or new or worsening respiratory symptoms.

• Chest imaging: Bilateral opacities on x-ray or CT scan not fully explained by effusions, lobar/lung collapse, or nodules.

• Origin of edema: Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present.

• Oxygenation:

Mild: PaO₂/FIO₂ of 201-300 mm Hg with positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) of 5 cm H₂O or greater.

Moderate: PaO₂/FIO₂ of 101-200 mm Hg with PEEP of 5 cm H₂O or greater.

Severe: PaO₂/FIO₂ of 100 mm Hg or less with PEEP of 5 cm H₂O or greater.

If the altitude is higher than 1,000 m, the correction factor should be calculated as PaO₂/RO₂ × (barometric pressure/760).

SAN FRANCISCO – A proposed new definition of acute respiratory distress syndrome describes categories based on mild, moderate, or severe hypoxemia that correlate increasing severity with significantly increased mortality or increased time on mechanical ventilation among survivors.

The draft definition, created under consensus process by an international panel of experts, was refined by empirical testing in a meta-analysis of data on 4,457 patients in two large data sets from seven centers. The risk of mortality from acute respiratory distress syndrome (ARDS) was 27% with mild disease, 32% with moderate ARDS, and 45% with severe ARDS, Dr. Niall D. Ferguson and Dr. Gordon D. Rubenfeld reported at an international conference of the American Thoracic Society.

Sherry Boschert/IMNG Medical Media

The median duration of mechanical ventilation in survivors was 5 days in patients with mild ARDS, 7 days with moderate ARDS, and 9 days with severe ARDS, said Dr. Ferguson, director of critical care medicine at the University of Toronto. The study was published online May 21 in JAMA (doi: 10.1001/jama.2012.5669).

The European Society of Intensive Care Medicine convened the panel of experts in Berlin in 2011 to draft a new definition of ARDS in hopes of improving upon the 1994 definition from the American-European Consensus Conference (AECC), said Dr. Rubenfeld, professor of medicine at the University of Toronto and chief of the program in trauma/emergency and critical care at Sunnybrook Health Sciences Center, Toronto. Since the AECC definition was adopted widely, issues of reliability and validity have emerged. The American Thoracic Society and the Society of Critical Care Medicine endorsed the 2011 consensus effort.

Under the new Berlin Definition, patients with mild ARDS have mild hypoxemia, defined as a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen of 201-300 mm Hg (PaO₂/FIO₂ = 201-300 mm Hg). Moderate hypoxia (PaO₂/FIO₂ = 101-200 mm Hg) defines moderate ARDS, and severe hypoxia (PaO₂/FIO₂ = 100 mm Hg or less) defines severe ARDS.

The initial draft of the Berlin Definition included four ancillary variables for severe ARDS that were dropped after the meta-analysis found that they did not improve the predictive value for mortality, the speakers and their associates in the study reported. The abandoned variables were radiographic severity, respiratory system compliance, positive end-expiratory pressure, and corrected expired volume per minute.

Dr. Rubenfeld stressed that these variables still are important for clinicians to measure and for understanding ARDS, but they were not included in the definition of severe ARDS because they made the definition more complex while not adding anything to the predictive value of the definition.

He also cautioned that neither the Berlin Definition nor the AECC definition is designed to be a prognostic model; the end point of mortality was used to hone the Berlin Definition.

The Berlin Definition had better predictive validity for mortality than the AECC definition in an analysis using the area under the receiver operating curve (AUROC) in logistic regression models. The Berlin Definition had an AUROC of 0.577, compared with 0.536 for the AECC definition, a statistically significant improvement.

The data for the meta-analysis came from four multicenter clinical studies and three single-center physiological studies, the investigators reported.

Twenty-two percent of patients met the Berlin Definition criteria for mild ARDS, 50% had moderate ARDS, and 28% had severe ARDS. Median ventilator-free days declined with severity of disease, from 20 days with mild ARDS to 16 days with moderate ARDS and 1 day with severe ARDS.

Among patients with mild ARDS at baseline under the Berlin Definition, 29% progressed to moderate disease and 4% progressed to severe disease within 7 days. Among patients with moderate ARDS at baseline, 13% progressed to severe disease within 7 days.

Sherry Boschert/IMNG Medical Media

The investigators suggested that this approach of combining consensus discussions with empirical evaluation might be a model for creating more accurate, evidence-based definitions for critical illness syndromes. Previous ARDS definitions relied on expert consensus alone.

Without the empirical evaluation that led to deleting the ancillary variables, a needlessly complex ARDS definition would have been proposed, Dr. Rubenfeld said.

The study was sponsored by the European Society of Intensive Care Medicine, the National Institutes of Health, and the Canadian Institutes of Health Research (CIHR). CareFusion provided in-kind support for the study. Dr. Ferguson was supported by a CIHR New Investigator Award. Dr. Rubenfeld reported having financial relationships with Ikaria, Faron, and Cerus. Some of his associates in the study reported financial relationships with Maquet Medical, Hemodec, Faron, AstraZeneca, U.S. Biotest, Sirius Genetics, Sanofi-Aventis, Immunetrics, Abbott, Eli Lilly, Ikaria, GlaxoSmithKline, Tarix, Apeiron, and/or Novalung.

The Berlin Definition of ARDS

• Timing: Within 1 week of a known clinical insult or new or worsening respiratory symptoms.

• Chest imaging: Bilateral opacities on x-ray or CT scan not fully explained by effusions, lobar/lung collapse, or nodules.

• Origin of edema: Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present.

• Oxygenation:

Mild: PaO₂/FIO₂ of 201-300 mm Hg with positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) of 5 cm H₂O or greater.

Moderate: PaO₂/FIO₂ of 101-200 mm Hg with PEEP of 5 cm H₂O or greater.

Severe: PaO₂/FIO₂ of 100 mm Hg or less with PEEP of 5 cm H₂O or greater.

If the altitude is higher than 1,000 m, the correction factor should be calculated as PaO₂/RO₂ × (barometric pressure/760).

SAN FRANCISCO – Indwelling pleural catheters did not provide greater relief of dyspnea, cause less chest pain, or improve quality of life compared with chest tube and talc pleurodesis in patients with symptomatic malignant pleural effusion, an unblinded, randomized study of 106 patients found.

Patients receiving indwelling pleural catheters (IPCs) had a shorter initial hospitalization (0 days vs. 4 days) but were five times more likely to develop adverse events, Najib M. Rahman, D.Phil., reported at an international conference of the American Thoracic Society.

The study was published online May 20, 2012 (JAMA 2012;307 [doi:10.1001/jama.2012.5535]). The lead investigator of the Second Therapeutic Intervention in Malignant Effusion Trial (TIME2) was Dr. Helen E. Davies of University Hospital of Wales, Cardiff.

The patients from seven UK centers had undergone no prior pleurodesis. In the IPC group, outpatients had the IPC inserted, had a large volume drained, and were educated to do subsequent drainage at home. In the talc group, patients were admitted for chest tube insertion and talc for slurry pleurodesis. All patients were asked to assess their dyspnea daily at the same time each day using a 100-mm visual analog scale (VAS), with 0 mm indicating no dyspnea and 100 mm representing maximum dyspnea.

Dyspnea improved in both groups. Overall, mean VAS scores decreased by 37 mm from baseline with IPC and by 30 mm with talc, which was not significantly different. Dyspnea scores did not differ significantly between groups in the first 42 days, the primary outcome measured. At 6 months, however, there was a statistically significantly greater improvement in dyspnea in the IPC group, with a mean 14-mm lower score than the talc group.

"IPC may be better than talc at 6 months" of follow-up, said Dr. Rahman of the University of Oxford (England).

In the talc group, 22% of patients required further pleural procedures, compared with 6% in the IPC group, a significant difference. Five patients in the IPC group developed pleural infection, compared with one patient in the talc group.

"A lot of chest physicians think talc pleurodesis is more painful, but it turns out that IPC is painful too," he said. Scores for chest pain and for quality of life did not differ significantly between groups.

The study was not powered to assess mortality risk, but no significant differences were seen between groups out to 12 months of follow-up.

"We must not conclude that IPCs and talc are the same" or equivalent, Dr. Rahman said. The investigators are assessing the cost implications of the results, including costs for procedures and complications after the initial treatment.

The results should be interpreted with caution because the study was powered to assess superiority, not equivalence between treatments, Dr. Nick A. Maskell said in an editorial in the same issue (JAMA 2012;307 [doi:10.1001/jama.2012.5543]).

Clinicians for years have debated the best management of malignant pleural effusions. Talc is recommended as first-line treatment of symptomatic patients by international guidelines, said Dr. Maskell of the University of Bristol (England).

Based on the TIME2 study findings, physicians should feel comfortable discussing the advantages and disadvantages of both treatments with patients to help them pick the strategy that best suits them, he said.

Combining the best of both strategies may be the way of the future, Dr. Maskell added. Some preliminary studies suggest it may be feasible and beneficial to deliver pleurodesis agents via an IPC in the outpatient setting.

The only other randomized controlled trial comparing IPCs with pleurodesis for malignant pleural effusion used doxycycline, which is not as effective as talc, and found similar improvements in dyspnea and quality of life between groups, he said (Cancer 1999;86:1992-9).

The study was funded by the British Lung Foundation and the Robert Luff Foundation. Dr. Rahman reported being a consultant to Rocket Medical, which supplied the IPCs and drainage bottles for the trial. Some of his associates reported financial associations with Boehringer Ingelheim, Medico, AstraZeneca, GlaxoSmithKline, Chiese, CareFusion, Sequana Medical, Merck, and Gilead. Dr. Maskell disclosed receiving honoraria and grants from Carefusion.

SAN FRANCISCO – Indwelling pleural catheters did not provide greater relief of dyspnea, cause less chest pain, or improve quality of life compared with chest tube and talc pleurodesis in patients with symptomatic malignant pleural effusion, an unblinded, randomized study of 106 patients found.

Patients receiving indwelling pleural catheters (IPCs) had a shorter initial hospitalization (0 days vs. 4 days) but were five times more likely to develop adverse events, Najib M. Rahman, D.Phil., reported at an international conference of the American Thoracic Society.

The study was published online May 20, 2012 (JAMA 2012;307 [doi:10.1001/jama.2012.5535]). The lead investigator of the Second Therapeutic Intervention in Malignant Effusion Trial (TIME2) was Dr. Helen E. Davies of University Hospital of Wales, Cardiff.

The patients from seven UK centers had undergone no prior pleurodesis. In the IPC group, outpatients had the IPC inserted, had a large volume drained, and were educated to do subsequent drainage at home. In the talc group, patients were admitted for chest tube insertion and talc for slurry pleurodesis. All patients were asked to assess their dyspnea daily at the same time each day using a 100-mm visual analog scale (VAS), with 0 mm indicating no dyspnea and 100 mm representing maximum dyspnea.

Dyspnea improved in both groups. Overall, mean VAS scores decreased by 37 mm from baseline with IPC and by 30 mm with talc, which was not significantly different. Dyspnea scores did not differ significantly between groups in the first 42 days, the primary outcome measured. At 6 months, however, there was a statistically significantly greater improvement in dyspnea in the IPC group, with a mean 14-mm lower score than the talc group.

"IPC may be better than talc at 6 months" of follow-up, said Dr. Rahman of the University of Oxford (England).

In the talc group, 22% of patients required further pleural procedures, compared with 6% in the IPC group, a significant difference. Five patients in the IPC group developed pleural infection, compared with one patient in the talc group.

"A lot of chest physicians think talc pleurodesis is more painful, but it turns out that IPC is painful too," he said. Scores for chest pain and for quality of life did not differ significantly between groups.

The study was not powered to assess mortality risk, but no significant differences were seen between groups out to 12 months of follow-up.

"We must not conclude that IPCs and talc are the same" or equivalent, Dr. Rahman said. The investigators are assessing the cost implications of the results, including costs for procedures and complications after the initial treatment.

The results should be interpreted with caution because the study was powered to assess superiority, not equivalence between treatments, Dr. Nick A. Maskell said in an editorial in the same issue (JAMA 2012;307 [doi:10.1001/jama.2012.5543]).

Clinicians for years have debated the best management of malignant pleural effusions. Talc is recommended as first-line treatment of symptomatic patients by international guidelines, said Dr. Maskell of the University of Bristol (England).

Based on the TIME2 study findings, physicians should feel comfortable discussing the advantages and disadvantages of both treatments with patients to help them pick the strategy that best suits them, he said.

Combining the best of both strategies may be the way of the future, Dr. Maskell added. Some preliminary studies suggest it may be feasible and beneficial to deliver pleurodesis agents via an IPC in the outpatient setting.

The only other randomized controlled trial comparing IPCs with pleurodesis for malignant pleural effusion used doxycycline, which is not as effective as talc, and found similar improvements in dyspnea and quality of life between groups, he said (Cancer 1999;86:1992-9).

The study was funded by the British Lung Foundation and the Robert Luff Foundation. Dr. Rahman reported being a consultant to Rocket Medical, which supplied the IPCs and drainage bottles for the trial. Some of his associates reported financial associations with Boehringer Ingelheim, Medico, AstraZeneca, GlaxoSmithKline, Chiese, CareFusion, Sequana Medical, Merck, and Gilead. Dr. Maskell disclosed receiving honoraria and grants from Carefusion.

SAN FRANCISCO – Indwelling pleural catheters did not provide greater relief of dyspnea, cause less chest pain, or improve quality of life compared with chest tube and talc pleurodesis in patients with symptomatic malignant pleural effusion, an unblinded, randomized study of 106 patients found.

Patients receiving indwelling pleural catheters (IPCs) had a shorter initial hospitalization (0 days vs. 4 days) but were five times more likely to develop adverse events, Najib M. Rahman, D.Phil., reported at an international conference of the American Thoracic Society.

The study was published online May 20, 2012 (JAMA 2012;307 [doi:10.1001/jama.2012.5535]). The lead investigator of the Second Therapeutic Intervention in Malignant Effusion Trial (TIME2) was Dr. Helen E. Davies of University Hospital of Wales, Cardiff.

The patients from seven UK centers had undergone no prior pleurodesis. In the IPC group, outpatients had the IPC inserted, had a large volume drained, and were educated to do subsequent drainage at home. In the talc group, patients were admitted for chest tube insertion and talc for slurry pleurodesis. All patients were asked to assess their dyspnea daily at the same time each day using a 100-mm visual analog scale (VAS), with 0 mm indicating no dyspnea and 100 mm representing maximum dyspnea.

Dyspnea improved in both groups. Overall, mean VAS scores decreased by 37 mm from baseline with IPC and by 30 mm with talc, which was not significantly different. Dyspnea scores did not differ significantly between groups in the first 42 days, the primary outcome measured. At 6 months, however, there was a statistically significantly greater improvement in dyspnea in the IPC group, with a mean 14-mm lower score than the talc group.

"IPC may be better than talc at 6 months" of follow-up, said Dr. Rahman of the University of Oxford (England).

In the talc group, 22% of patients required further pleural procedures, compared with 6% in the IPC group, a significant difference. Five patients in the IPC group developed pleural infection, compared with one patient in the talc group.

"A lot of chest physicians think talc pleurodesis is more painful, but it turns out that IPC is painful too," he said. Scores for chest pain and for quality of life did not differ significantly between groups.

The study was not powered to assess mortality risk, but no significant differences were seen between groups out to 12 months of follow-up.

"We must not conclude that IPCs and talc are the same" or equivalent, Dr. Rahman said. The investigators are assessing the cost implications of the results, including costs for procedures and complications after the initial treatment.

The results should be interpreted with caution because the study was powered to assess superiority, not equivalence between treatments, Dr. Nick A. Maskell said in an editorial in the same issue (JAMA 2012;307 [doi:10.1001/jama.2012.5543]).

Clinicians for years have debated the best management of malignant pleural effusions. Talc is recommended as first-line treatment of symptomatic patients by international guidelines, said Dr. Maskell of the University of Bristol (England).

Based on the TIME2 study findings, physicians should feel comfortable discussing the advantages and disadvantages of both treatments with patients to help them pick the strategy that best suits them, he said.

Combining the best of both strategies may be the way of the future, Dr. Maskell added. Some preliminary studies suggest it may be feasible and beneficial to deliver pleurodesis agents via an IPC in the outpatient setting.

The only other randomized controlled trial comparing IPCs with pleurodesis for malignant pleural effusion used doxycycline, which is not as effective as talc, and found similar improvements in dyspnea and quality of life between groups, he said (Cancer 1999;86:1992-9).

The study was funded by the British Lung Foundation and the Robert Luff Foundation. Dr. Rahman reported being a consultant to Rocket Medical, which supplied the IPCs and drainage bottles for the trial. Some of his associates reported financial associations with Boehringer Ingelheim, Medico, AstraZeneca, GlaxoSmithKline, Chiese, CareFusion, Sequana Medical, Merck, and Gilead. Dr. Maskell disclosed receiving honoraria and grants from Carefusion.

SAN DIEGO – Oral tranexamic acid tablets at a dose of up to 3.9 g/day reduced blood loss by a mean of at least 60-65 mL per menstrual period in women aged 30 or older with heavy menstrual bleeding, a pooled analysis of two pivotal trials found.

Dr. Jeffrey B. Baker and his associates analyzed data for 383 women from the two randomized, double-blind, placebo-controlled studies who were randomized to either a 3.9-g/day group or placebo. One study also included a treatment arm using 1.95 g/day of tranexamic acid (Lysteda), but that dosage did not reduce menstrual bleeding by at least 50 mL, the minimum required by the Food and Drug Administration to show a significant difference, he said at the annual meeting of the American College of Obstetricians and Gynecologists.

In November 2010, the FDA approved the 3.9 g/day dosage of Lysteda to treat heavy menstrual bleeding based on results from the pivotal trials (Obstet. Gynecol. 2010;116:865-75; Am. J. Obstet. Gynecol. 2011;205:319.e1-7).

Women who were randomized to the 3.9 g/day groups took the drug for up to 5 days per menstrual cycle for either three or six menstrual cycles, depending on the study. They could decide to take it for no days or for up to 5 days in any one cycle; they averaged 2.5 days of the medication per cycle.

In the current analysis of data pooled from both studies, reductions in menstrual blood loss tended to be greater with increasing patient age. Women younger than 30 years had a mean reduction in menstrual blood loss of approximately 40 mL, below the desired 50-mL threshold. A 60- to 65-mL reduction in bleeding was seen in women in age groups of 30-34 years, 35-39 years, and 40-49 years. The reduction in blood loss in women aged 45 years or older averaged more than 80 mL per period, said Dr. Baker, an ob.gyn. and clinical researcher in private practice in Idaho Falls, Idaho.

For women on placebo in those age groups, the mean change in menstrual blood loss ranged from an approximately 10-mL reduction to slight increases in blood loss.

"What tranexamic acid offers to clinicians and patients is another tool amongst the many tools that are available for heavy menstrual bleeding," he said.

Some of the available hormonal treatments for heavy menstrual bleeding, such as the Mirena IUD, also act as contraceptives. Lysteda is a nonhormonal lysine analog that acts as a competitive plasmin inhibitor; it is not a contraceptive. The studies excluded the use of any hormonal products that might compromise the effectiveness of Lysteda, so women used barrier techniques, tubal ligations, or vasectomies for birth control, he said.

Women with fibroids saw a slightly greater reduction in menstrual blood loss, compared with those without fibroids (approximately 75 mL and 60 mL, respectively). Women with a body mass index less than 25 kg/m² had an approximately 75-mL reduction in blood loss, compared with approximately 65-mL reductions for women in two other BMI categories (25-29, or 30 or greater).

Treatment-emergent serious adverse events in the 3.9-g/day groups included tachycardia in one woman, low blood sugar in one woman, severe ovarian torsion in one woman, and complaints of severe dyspepsia, severe gastritis, and severe chest pain in one woman. The investigators considered these to be unrelated to treatment.

Four women in the 3.9-g/day groups withdrew from the studies. The reasons given were mild myalgias, elevated FSH level, rash, or palpitations, each of which resolved by the time of the follow-up visit.

The most common adverse events in the Lysteda groups were upper respiratory infection (7%), musculoskeletal pain (5%), and myalgia (5%) in one study, and headache (11%), nausea (10%), and menstrual discomfort (8%) in the other study. Most adverse events were mild to moderate in severity. The Lysteda and placebo groups did not differ significantly in treatment-emergent adverse events.

In response to a question from the audience, Dr. Baker said that the studies did not screen patients for underlying thrombophilias.

The studies included adult women with no abnormal findings on pelvic examination as well as normal cervical cytology results and normal findings on transvaginal ultrasound. Women with fibroids or simple ovarian cysts were allowed to participate. The studies excluded women with severe anemia or other identifiable causes of abnormal menstrual bleeding.

Two previous studies found that tranexamic acid reduced menstrual blood loss in women with heavy menstrual bleeding, Dr. Baker noted (Acta Obstet. Gynecol. Scand. 1994;73:274-7; Drugs 2003;63:1417-33).

Ferring Pharmaceuticals, which markets Lysteda, funded the study. Dr. Baker has been a speaker and advisor for Ferring. One of his coinvestigators is an employee of Ferring, and the other has been a speaker and advisor for Ferring and a consultant or researcher for multiple other companies.

SAN DIEGO – Oral tranexamic acid tablets at a dose of up to 3.9 g/day reduced blood loss by a mean of at least 60-65 mL per menstrual period in women aged 30 or older with heavy menstrual bleeding, a pooled analysis of two pivotal trials found.

Dr. Jeffrey B. Baker and his associates analyzed data for 383 women from the two randomized, double-blind, placebo-controlled studies who were randomized to either a 3.9-g/day group or placebo. One study also included a treatment arm using 1.95 g/day of tranexamic acid (Lysteda), but that dosage did not reduce menstrual bleeding by at least 50 mL, the minimum required by the Food and Drug Administration to show a significant difference, he said at the annual meeting of the American College of Obstetricians and Gynecologists.

In November 2010, the FDA approved the 3.9 g/day dosage of Lysteda to treat heavy menstrual bleeding based on results from the pivotal trials (Obstet. Gynecol. 2010;116:865-75; Am. J. Obstet. Gynecol. 2011;205:319.e1-7).

Women who were randomized to the 3.9 g/day groups took the drug for up to 5 days per menstrual cycle for either three or six menstrual cycles, depending on the study. They could decide to take it for no days or for up to 5 days in any one cycle; they averaged 2.5 days of the medication per cycle.

In the current analysis of data pooled from both studies, reductions in menstrual blood loss tended to be greater with increasing patient age. Women younger than 30 years had a mean reduction in menstrual blood loss of approximately 40 mL, below the desired 50-mL threshold. A 60- to 65-mL reduction in bleeding was seen in women in age groups of 30-34 years, 35-39 years, and 40-49 years. The reduction in blood loss in women aged 45 years or older averaged more than 80 mL per period, said Dr. Baker, an ob.gyn. and clinical researcher in private practice in Idaho Falls, Idaho.

For women on placebo in those age groups, the mean change in menstrual blood loss ranged from an approximately 10-mL reduction to slight increases in blood loss.

"What tranexamic acid offers to clinicians and patients is another tool amongst the many tools that are available for heavy menstrual bleeding," he said.

Some of the available hormonal treatments for heavy menstrual bleeding, such as the Mirena IUD, also act as contraceptives. Lysteda is a nonhormonal lysine analog that acts as a competitive plasmin inhibitor; it is not a contraceptive. The studies excluded the use of any hormonal products that might compromise the effectiveness of Lysteda, so women used barrier techniques, tubal ligations, or vasectomies for birth control, he said.

Women with fibroids saw a slightly greater reduction in menstrual blood loss, compared with those without fibroids (approximately 75 mL and 60 mL, respectively). Women with a body mass index less than 25 kg/m² had an approximately 75-mL reduction in blood loss, compared with approximately 65-mL reductions for women in two other BMI categories (25-29, or 30 or greater).

Treatment-emergent serious adverse events in the 3.9-g/day groups included tachycardia in one woman, low blood sugar in one woman, severe ovarian torsion in one woman, and complaints of severe dyspepsia, severe gastritis, and severe chest pain in one woman. The investigators considered these to be unrelated to treatment.

Four women in the 3.9-g/day groups withdrew from the studies. The reasons given were mild myalgias, elevated FSH level, rash, or palpitations, each of which resolved by the time of the follow-up visit.

The most common adverse events in the Lysteda groups were upper respiratory infection (7%), musculoskeletal pain (5%), and myalgia (5%) in one study, and headache (11%), nausea (10%), and menstrual discomfort (8%) in the other study. Most adverse events were mild to moderate in severity. The Lysteda and placebo groups did not differ significantly in treatment-emergent adverse events.

In response to a question from the audience, Dr. Baker said that the studies did not screen patients for underlying thrombophilias.

The studies included adult women with no abnormal findings on pelvic examination as well as normal cervical cytology results and normal findings on transvaginal ultrasound. Women with fibroids or simple ovarian cysts were allowed to participate. The studies excluded women with severe anemia or other identifiable causes of abnormal menstrual bleeding.

Two previous studies found that tranexamic acid reduced menstrual blood loss in women with heavy menstrual bleeding, Dr. Baker noted (Acta Obstet. Gynecol. Scand. 1994;73:274-7; Drugs 2003;63:1417-33).

Ferring Pharmaceuticals, which markets Lysteda, funded the study. Dr. Baker has been a speaker and advisor for Ferring. One of his coinvestigators is an employee of Ferring, and the other has been a speaker and advisor for Ferring and a consultant or researcher for multiple other companies.

SAN DIEGO – Oral tranexamic acid tablets at a dose of up to 3.9 g/day reduced blood loss by a mean of at least 60-65 mL per menstrual period in women aged 30 or older with heavy menstrual bleeding, a pooled analysis of two pivotal trials found.

Dr. Jeffrey B. Baker and his associates analyzed data for 383 women from the two randomized, double-blind, placebo-controlled studies who were randomized to either a 3.9-g/day group or placebo. One study also included a treatment arm using 1.95 g/day of tranexamic acid (Lysteda), but that dosage did not reduce menstrual bleeding by at least 50 mL, the minimum required by the Food and Drug Administration to show a significant difference, he said at the annual meeting of the American College of Obstetricians and Gynecologists.

In November 2010, the FDA approved the 3.9 g/day dosage of Lysteda to treat heavy menstrual bleeding based on results from the pivotal trials (Obstet. Gynecol. 2010;116:865-75; Am. J. Obstet. Gynecol. 2011;205:319.e1-7).

Women who were randomized to the 3.9 g/day groups took the drug for up to 5 days per menstrual cycle for either three or six menstrual cycles, depending on the study. They could decide to take it for no days or for up to 5 days in any one cycle; they averaged 2.5 days of the medication per cycle.

In the current analysis of data pooled from both studies, reductions in menstrual blood loss tended to be greater with increasing patient age. Women younger than 30 years had a mean reduction in menstrual blood loss of approximately 40 mL, below the desired 50-mL threshold. A 60- to 65-mL reduction in bleeding was seen in women in age groups of 30-34 years, 35-39 years, and 40-49 years. The reduction in blood loss in women aged 45 years or older averaged more than 80 mL per period, said Dr. Baker, an ob.gyn. and clinical researcher in private practice in Idaho Falls, Idaho.

For women on placebo in those age groups, the mean change in menstrual blood loss ranged from an approximately 10-mL reduction to slight increases in blood loss.

"What tranexamic acid offers to clinicians and patients is another tool amongst the many tools that are available for heavy menstrual bleeding," he said.

Some of the available hormonal treatments for heavy menstrual bleeding, such as the Mirena IUD, also act as contraceptives. Lysteda is a nonhormonal lysine analog that acts as a competitive plasmin inhibitor; it is not a contraceptive. The studies excluded the use of any hormonal products that might compromise the effectiveness of Lysteda, so women used barrier techniques, tubal ligations, or vasectomies for birth control, he said.

Women with fibroids saw a slightly greater reduction in menstrual blood loss, compared with those without fibroids (approximately 75 mL and 60 mL, respectively). Women with a body mass index less than 25 kg/m² had an approximately 75-mL reduction in blood loss, compared with approximately 65-mL reductions for women in two other BMI categories (25-29, or 30 or greater).

Treatment-emergent serious adverse events in the 3.9-g/day groups included tachycardia in one woman, low blood sugar in one woman, severe ovarian torsion in one woman, and complaints of severe dyspepsia, severe gastritis, and severe chest pain in one woman. The investigators considered these to be unrelated to treatment.

Four women in the 3.9-g/day groups withdrew from the studies. The reasons given were mild myalgias, elevated FSH level, rash, or palpitations, each of which resolved by the time of the follow-up visit.

The most common adverse events in the Lysteda groups were upper respiratory infection (7%), musculoskeletal pain (5%), and myalgia (5%) in one study, and headache (11%), nausea (10%), and menstrual discomfort (8%) in the other study. Most adverse events were mild to moderate in severity. The Lysteda and placebo groups did not differ significantly in treatment-emergent adverse events.

In response to a question from the audience, Dr. Baker said that the studies did not screen patients for underlying thrombophilias.

The studies included adult women with no abnormal findings on pelvic examination as well as normal cervical cytology results and normal findings on transvaginal ultrasound. Women with fibroids or simple ovarian cysts were allowed to participate. The studies excluded women with severe anemia or other identifiable causes of abnormal menstrual bleeding.

Two previous studies found that tranexamic acid reduced menstrual blood loss in women with heavy menstrual bleeding, Dr. Baker noted (Acta Obstet. Gynecol. Scand. 1994;73:274-7; Drugs 2003;63:1417-33).

Ferring Pharmaceuticals, which markets Lysteda, funded the study. Dr. Baker has been a speaker and advisor for Ferring. One of his coinvestigators is an employee of Ferring, and the other has been a speaker and advisor for Ferring and a consultant or researcher for multiple other companies.

SAN DIEGO – Women expelled 54% of intrauterine devices placed immediately after giving birth, compared with a 6% expulsion rate after conventional placement at 6 weeks post partum or later, a study of an indigent population found.

The expulsion rate in the immediate-placement group (12 of 22 women) was significantly higher than when the levonorgestrel-containing intrauterine device (the Mirena IUD) was placed 6 weeks postpartum or later (1 of 18 women). The finding suggests that the immediate-placement strategy is prohibitively expensive, Dr. Tiffany D. Justice and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Photo courtesy Mirena-US.com

Immediate placement after delivery might be acceptable for women who are nearly certain to not return for follow-up visits after delivery, but even in those cases, a different long-acting reversible contraceptive such as a progesterone-containing implant might make more sense, said Dr. Justice, an ob.gyn. specializing in reproductive endocrinology and infertility at the University of Louisville, Ky.

The study randomized women who desired contraception after delivery in a university-based prenatal obstetrics clinic that primarily serves the indigent. In the immediate-placement group, women received the IUD within 10 minutes after placental delivery.

Among 32 women randomized to immediate IUD placement, 9 patients did not receive one due to cesarean section delivery (5 patients), infection in 2 patients, and a change of mind by 2 patients. One patient who got immediate placement was lost to follow-up and 22 returned at 6 weeks post partum for a repeat ultrasound to confirm placement.

Among 34 women randomized to standard-interval IUD placement, 5 were disqualified due to cesarean section (2), infection (1), or a change of mind (1). Eleven of the remaining 29 patients did not return as planned for IUD placement 6 weeks post partum or later (38%), a high rate of patients being lost to follow-up in this group, Dr. Justice said.

Despite the poor follow-up rate in the standard-interval group, 59% had an IUD in place at 6 months post partum, significantly greater than the 46% of patients in the immediate placement group who were still using their original IUD at 6 months.

In general, 60% of women in the university-based system who choose an IUD for postpartum contraception never return for placement, she said. Ovulation resumes very quickly after delivery in all women and especially in those who do not breastfeed, creating a risk for repeat conception as soon as 4 weeks after delivery. Unintended pregnancies are a huge problem affecting nearly half of all pregnancies.

The comparison groups in the current study did not differ significantly in age, proportion of nulliparous women, gestational age, length of rupture of membranes, infant weight, breastfeeding rate, use of epidurals, race, or rates of infection, perforation, or unintended pregnancy.

Follow-up ultrasounds in the immediate placement group found that some women had the IUD oriented obliquely or upside down at the fundus, but it’s not clear if these abnormal orientations within the uterine cavity had any significance, Dr. Justice said.

A previous study reported a 24% expulsion rate after immediate postpartum placement of an IUD, compared with a 4% expulsion rate after standard interval placement (Obstet. Gynecol. 2010;116:1079-87).

The 54% expulsion rate after immediate placement in the current study "is a closer approximation to the expected experience in general practice and represents a ‘typical use’ in that multiple physicians placed the device over the length of the study," Dr. Justice said.

Studies are underway to assess placement of progesterone-containing implants immediately after delivery, she said.

Dr. Justice reported having no relevant financial disclosures.

SAN DIEGO – Women expelled 54% of intrauterine devices placed immediately after giving birth, compared with a 6% expulsion rate after conventional placement at 6 weeks post partum or later, a study of an indigent population found.

The expulsion rate in the immediate-placement group (12 of 22 women) was significantly higher than when the levonorgestrel-containing intrauterine device (the Mirena IUD) was placed 6 weeks postpartum or later (1 of 18 women). The finding suggests that the immediate-placement strategy is prohibitively expensive, Dr. Tiffany D. Justice and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Photo courtesy Mirena-US.com

Immediate placement after delivery might be acceptable for women who are nearly certain to not return for follow-up visits after delivery, but even in those cases, a different long-acting reversible contraceptive such as a progesterone-containing implant might make more sense, said Dr. Justice, an ob.gyn. specializing in reproductive endocrinology and infertility at the University of Louisville, Ky.

The study randomized women who desired contraception after delivery in a university-based prenatal obstetrics clinic that primarily serves the indigent. In the immediate-placement group, women received the IUD within 10 minutes after placental delivery.

Among 32 women randomized to immediate IUD placement, 9 patients did not receive one due to cesarean section delivery (5 patients), infection in 2 patients, and a change of mind by 2 patients. One patient who got immediate placement was lost to follow-up and 22 returned at 6 weeks post partum for a repeat ultrasound to confirm placement.

Among 34 women randomized to standard-interval IUD placement, 5 were disqualified due to cesarean section (2), infection (1), or a change of mind (1). Eleven of the remaining 29 patients did not return as planned for IUD placement 6 weeks post partum or later (38%), a high rate of patients being lost to follow-up in this group, Dr. Justice said.

Despite the poor follow-up rate in the standard-interval group, 59% had an IUD in place at 6 months post partum, significantly greater than the 46% of patients in the immediate placement group who were still using their original IUD at 6 months.

In general, 60% of women in the university-based system who choose an IUD for postpartum contraception never return for placement, she said. Ovulation resumes very quickly after delivery in all women and especially in those who do not breastfeed, creating a risk for repeat conception as soon as 4 weeks after delivery. Unintended pregnancies are a huge problem affecting nearly half of all pregnancies.

The comparison groups in the current study did not differ significantly in age, proportion of nulliparous women, gestational age, length of rupture of membranes, infant weight, breastfeeding rate, use of epidurals, race, or rates of infection, perforation, or unintended pregnancy.

Follow-up ultrasounds in the immediate placement group found that some women had the IUD oriented obliquely or upside down at the fundus, but it’s not clear if these abnormal orientations within the uterine cavity had any significance, Dr. Justice said.

A previous study reported a 24% expulsion rate after immediate postpartum placement of an IUD, compared with a 4% expulsion rate after standard interval placement (Obstet. Gynecol. 2010;116:1079-87).

The 54% expulsion rate after immediate placement in the current study "is a closer approximation to the expected experience in general practice and represents a ‘typical use’ in that multiple physicians placed the device over the length of the study," Dr. Justice said.

Studies are underway to assess placement of progesterone-containing implants immediately after delivery, she said.

Dr. Justice reported having no relevant financial disclosures.

SAN DIEGO – Women expelled 54% of intrauterine devices placed immediately after giving birth, compared with a 6% expulsion rate after conventional placement at 6 weeks post partum or later, a study of an indigent population found.

The expulsion rate in the immediate-placement group (12 of 22 women) was significantly higher than when the levonorgestrel-containing intrauterine device (the Mirena IUD) was placed 6 weeks postpartum or later (1 of 18 women). The finding suggests that the immediate-placement strategy is prohibitively expensive, Dr. Tiffany D. Justice and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Photo courtesy Mirena-US.com

Immediate placement after delivery might be acceptable for women who are nearly certain to not return for follow-up visits after delivery, but even in those cases, a different long-acting reversible contraceptive such as a progesterone-containing implant might make more sense, said Dr. Justice, an ob.gyn. specializing in reproductive endocrinology and infertility at the University of Louisville, Ky.

The study randomized women who desired contraception after delivery in a university-based prenatal obstetrics clinic that primarily serves the indigent. In the immediate-placement group, women received the IUD within 10 minutes after placental delivery.

Among 32 women randomized to immediate IUD placement, 9 patients did not receive one due to cesarean section delivery (5 patients), infection in 2 patients, and a change of mind by 2 patients. One patient who got immediate placement was lost to follow-up and 22 returned at 6 weeks post partum for a repeat ultrasound to confirm placement.

Among 34 women randomized to standard-interval IUD placement, 5 were disqualified due to cesarean section (2), infection (1), or a change of mind (1). Eleven of the remaining 29 patients did not return as planned for IUD placement 6 weeks post partum or later (38%), a high rate of patients being lost to follow-up in this group, Dr. Justice said.

Despite the poor follow-up rate in the standard-interval group, 59% had an IUD in place at 6 months post partum, significantly greater than the 46% of patients in the immediate placement group who were still using their original IUD at 6 months.

In general, 60% of women in the university-based system who choose an IUD for postpartum contraception never return for placement, she said. Ovulation resumes very quickly after delivery in all women and especially in those who do not breastfeed, creating a risk for repeat conception as soon as 4 weeks after delivery. Unintended pregnancies are a huge problem affecting nearly half of all pregnancies.

The comparison groups in the current study did not differ significantly in age, proportion of nulliparous women, gestational age, length of rupture of membranes, infant weight, breastfeeding rate, use of epidurals, race, or rates of infection, perforation, or unintended pregnancy.

Follow-up ultrasounds in the immediate placement group found that some women had the IUD oriented obliquely or upside down at the fundus, but it’s not clear if these abnormal orientations within the uterine cavity had any significance, Dr. Justice said.

A previous study reported a 24% expulsion rate after immediate postpartum placement of an IUD, compared with a 4% expulsion rate after standard interval placement (Obstet. Gynecol. 2010;116:1079-87).

The 54% expulsion rate after immediate placement in the current study "is a closer approximation to the expected experience in general practice and represents a ‘typical use’ in that multiple physicians placed the device over the length of the study," Dr. Justice said.

Studies are underway to assess placement of progesterone-containing implants immediately after delivery, she said.

Dr. Justice reported having no relevant financial disclosures.

SAN DIEGO – Hospitals that employed more hospitalists had modestly higher patient satisfaction scores in an analysis of 2009 Medicare data for 135,722 patients at 2,843 hospitals.

Patient satisfaction scores came from the Hospital Consumer Assessment of Healthcare Providers and System, a 27-item survey that, starting in 2006, was administered to random adult patients within 48 hours to 6 weeks after discharge from the hospitals.

Approximately 63.5% patients at nonhospitalist hospitals would recommend the hospital to others, as would approximately 64.5% of patients at mixed hospitals and 66% of patients at hospitalist hospitals,

Use of hospitalists varied widely, with no hospitalists caring for general medicine patients at 17% of hospitals and all general medicine patients being cared for by hospitalists at less than 4% of hospitals. The analysis grouped hospitals as one of three types. "Nonhospitalist" facilities had 0%-20% of patients cared for by hospitalists. "Mixed" hospitals used hospitalists for 21%-50% of general medicine patients, and "hospitalist" hospitals placed 61%-100% of general medicine patients under hospitalist care.

Overall patient satisfaction rates were approximately 64% for nonhospitalist or mixed hospitals and nearly 66% for hospitalist facilities, Dr. Lena M. Chen and her associates reported at the annual meeting of the Society of Hospital Medicine.

Approximately 63.5% of the 33,265 patients at nonhospitalist hospitals would recommend the hospital to others, as would approximately 64.5% of the 52,844 patients at mixed hospitals and 66% of the 46,705 patients at hospitalist hospitals, said Dr. Chen of the University of Michigan, Ann Arbor.

On individual items, the largest difference between facilities was in patient satisfaction with discharge – an 80% rating at hospitalist facilities, which was significantly higher than the 78% rating for nonhospitalist hospitals. Smaller, but still statistically significant, differences were seen in higher satisfaction scores for hospitalist vs. nonhospitalist facilities in ratings on nursing services, quiet, communication with nurses, pain control, and communication about medications.

Starting in October 2012, Medicare will base part of its hospital payments on patient satisfaction scores, Dr. Chen noted. Inpatients increasingly are likely to be cared for by hospitalists.

"Given efforts to increase patient satisfaction, it would be important to understand why hospitals with more hospitalist care have higher patient satisfaction," she said.

The analysis adjusted for potentially confounding effects of various differences between types of hospitals. Nonhospitalist hospitals were significantly less likely to be teaching hospitals and significantly more likely to be in urban locations. Hospitalist facilities were significantly more likely to have a medical ICU and to have a higher nurse-to-bed ratio compared with nonhospitalist hospitals.

Hospitalists were defined as general internists with at least five Medicare billings in a year and with 90% or more of these billings from the care of hospitalized patients.

The 5% sample of elderly fee-for-service Medicare beneficiaries excluded patients with surgical admissions or readmissions, patients who did not have an acute care hospital stay, patients who were not cared for by a general internist, and patients who were cared for by both a hospitalist and nonhospitalists.

Dr. Chen reported having no financial disclosures.

SAN DIEGO – Hospitals that employed more hospitalists had modestly higher patient satisfaction scores in an analysis of 2009 Medicare data for 135,722 patients at 2,843 hospitals.

Patient satisfaction scores came from the Hospital Consumer Assessment of Healthcare Providers and System, a 27-item survey that, starting in 2006, was administered to random adult patients within 48 hours to 6 weeks after discharge from the hospitals.

Approximately 63.5% patients at nonhospitalist hospitals would recommend the hospital to others, as would approximately 64.5% of patients at mixed hospitals and 66% of patients at hospitalist hospitals,

Use of hospitalists varied widely, with no hospitalists caring for general medicine patients at 17% of hospitals and all general medicine patients being cared for by hospitalists at less than 4% of hospitals. The analysis grouped hospitals as one of three types. "Nonhospitalist" facilities had 0%-20% of patients cared for by hospitalists. "Mixed" hospitals used hospitalists for 21%-50% of general medicine patients, and "hospitalist" hospitals placed 61%-100% of general medicine patients under hospitalist care.

Overall patient satisfaction rates were approximately 64% for nonhospitalist or mixed hospitals and nearly 66% for hospitalist facilities, Dr. Lena M. Chen and her associates reported at the annual meeting of the Society of Hospital Medicine.

Approximately 63.5% of the 33,265 patients at nonhospitalist hospitals would recommend the hospital to others, as would approximately 64.5% of the 52,844 patients at mixed hospitals and 66% of the 46,705 patients at hospitalist hospitals, said Dr. Chen of the University of Michigan, Ann Arbor.

On individual items, the largest difference between facilities was in patient satisfaction with discharge – an 80% rating at hospitalist facilities, which was significantly higher than the 78% rating for nonhospitalist hospitals. Smaller, but still statistically significant, differences were seen in higher satisfaction scores for hospitalist vs. nonhospitalist facilities in ratings on nursing services, quiet, communication with nurses, pain control, and communication about medications.

Starting in October 2012, Medicare will base part of its hospital payments on patient satisfaction scores, Dr. Chen noted. Inpatients increasingly are likely to be cared for by hospitalists.

"Given efforts to increase patient satisfaction, it would be important to understand why hospitals with more hospitalist care have higher patient satisfaction," she said.

The analysis adjusted for potentially confounding effects of various differences between types of hospitals. Nonhospitalist hospitals were significantly less likely to be teaching hospitals and significantly more likely to be in urban locations. Hospitalist facilities were significantly more likely to have a medical ICU and to have a higher nurse-to-bed ratio compared with nonhospitalist hospitals.

Hospitalists were defined as general internists with at least five Medicare billings in a year and with 90% or more of these billings from the care of hospitalized patients.

The 5% sample of elderly fee-for-service Medicare beneficiaries excluded patients with surgical admissions or readmissions, patients who did not have an acute care hospital stay, patients who were not cared for by a general internist, and patients who were cared for by both a hospitalist and nonhospitalists.

Dr. Chen reported having no financial disclosures.

SAN DIEGO – Hospitals that employed more hospitalists had modestly higher patient satisfaction scores in an analysis of 2009 Medicare data for 135,722 patients at 2,843 hospitals.

Patient satisfaction scores came from the Hospital Consumer Assessment of Healthcare Providers and System, a 27-item survey that, starting in 2006, was administered to random adult patients within 48 hours to 6 weeks after discharge from the hospitals.

Approximately 63.5% patients at nonhospitalist hospitals would recommend the hospital to others, as would approximately 64.5% of patients at mixed hospitals and 66% of patients at hospitalist hospitals,

Use of hospitalists varied widely, with no hospitalists caring for general medicine patients at 17% of hospitals and all general medicine patients being cared for by hospitalists at less than 4% of hospitals. The analysis grouped hospitals as one of three types. "Nonhospitalist" facilities had 0%-20% of patients cared for by hospitalists. "Mixed" hospitals used hospitalists for 21%-50% of general medicine patients, and "hospitalist" hospitals placed 61%-100% of general medicine patients under hospitalist care.

Overall patient satisfaction rates were approximately 64% for nonhospitalist or mixed hospitals and nearly 66% for hospitalist facilities, Dr. Lena M. Chen and her associates reported at the annual meeting of the Society of Hospital Medicine.

Approximately 63.5% of the 33,265 patients at nonhospitalist hospitals would recommend the hospital to others, as would approximately 64.5% of the 52,844 patients at mixed hospitals and 66% of the 46,705 patients at hospitalist hospitals, said Dr. Chen of the University of Michigan, Ann Arbor.

On individual items, the largest difference between facilities was in patient satisfaction with discharge – an 80% rating at hospitalist facilities, which was significantly higher than the 78% rating for nonhospitalist hospitals. Smaller, but still statistically significant, differences were seen in higher satisfaction scores for hospitalist vs. nonhospitalist facilities in ratings on nursing services, quiet, communication with nurses, pain control, and communication about medications.

Starting in October 2012, Medicare will base part of its hospital payments on patient satisfaction scores, Dr. Chen noted. Inpatients increasingly are likely to be cared for by hospitalists.

"Given efforts to increase patient satisfaction, it would be important to understand why hospitals with more hospitalist care have higher patient satisfaction," she said.

The analysis adjusted for potentially confounding effects of various differences between types of hospitals. Nonhospitalist hospitals were significantly less likely to be teaching hospitals and significantly more likely to be in urban locations. Hospitalist facilities were significantly more likely to have a medical ICU and to have a higher nurse-to-bed ratio compared with nonhospitalist hospitals.

Hospitalists were defined as general internists with at least five Medicare billings in a year and with 90% or more of these billings from the care of hospitalized patients.

The 5% sample of elderly fee-for-service Medicare beneficiaries excluded patients with surgical admissions or readmissions, patients who did not have an acute care hospital stay, patients who were not cared for by a general internist, and patients who were cared for by both a hospitalist and nonhospitalists.

Dr. Chen reported having no financial disclosures.

SAN DIEGO – Something as simple as a stamp in a patient’s chart to remind medical providers about vaccinating against human papillomavirus nearly quintupled the percentage of eligible patients being vaccinated in one outpatient office, according to a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The faculty practice was vaccinating only 11% of eligible women before the trial, lower than the 2009 national average vaccination rate of 25%. After the office staff was instructed to place a reminder stamp in the progress notes of all nonpregnant women aged 18-26 years who were scheduled for an appointment with a gynecology provider, the office significantly improved its vaccination rate to 49% of eligible women, Dr. Kerry Rut and her associates reported.

Photo Sherry Boschert/IMNG Medical Mail

The prospective study compared charts for 86 patients who were eligible to receive the Gardasil vaccine for human papillomavirus (HPV) before use of the stamp and 70 patients after implementation of the stamp. Three of the six health care providers in the office (five physicians and a nurse practitioner) significantly increased their vaccinations of patients after the reminder stamp started appearing in progress notes, said Dr. Rut, an ob.gyn. in private practice in Bay Shore, N.Y. She led the study while she was a resident at Winthrop University Hospital, Mineola, N.Y.

The study received top prize among posters presented at the meeting.

Vaccination rates did not seem to be influenced by the reason for the patient’s visit or a history of abnormal Pap smear results. Only the use of the stamp was associated with vaccination rates.

The charts documented that the physician discussed Gardasil in 19 of 86 (22%) cases before use of the stamp and in 63 of 70 (90%) cases after use of the stamp, a significant increase. Still, less than half of eligible patients received the vaccine. When Gardasil was discussed, patients refused vaccination in 34 of 63 (54%) cases. The high refusal rate despite counseling suggests a need to investigate the type of patient education and its content, Dr. Rut suggested.

Patients averaged 23 years of age before use of the stamp and 22 years after the stamp, a statistically significant difference. The two groups did not differ significantly in the type of insurance, the reason for the visit, or the percentage with a previous abnormal Pap smear.

Each of the six medical providers increased their vaccination rates; the increase was statistically significant for three of them. The nurse practitioner had the highest vaccination rate before use of the stamp (4 of 12, or 33%) and after implementation of the stamp (11 of 14, or 79%), a significant increase.

One physician significantly increased vaccination rates from 6% before the stamp (1 of 17 patients) to 62% after the stamp (8 of 13 patients). Another physician significantly improved from vaccinating none of 14 patients before the stamp to 7 of 12 patients after the stamp (58%).

Of the three physicians whose improvement did not reach statistical significance, one went from vaccinating none of 15 patients before the stamp to 1 of 10 patients (10%) after the stamp. Another physician vaccinated 2 of 12 patients at baseline (17%) and 4 of 7 patients after the stamp started (57%). The third physician vaccinated 2 of 16 patients at baseline (13%) and 3 of 14 patients after the stamp (21%).

Overall, the vaccination rate increased from 9 of 86 patients before the stamp (11%) to 34 of 70 patients with use of the stamp (49%), Dr. Rut said.

The stamp included five boxes that the physician could check off: "Start series today," "Series in-progress," "3-vaccine series completed," "Counseled but refuses," and "Other."

As the use of electronic health records increases, perhaps a Gardasil reminder could be incorporated instead of a physical stamp to improve vaccination rates even more, she suggested.

Dr. Rut reported having no relevant financial disclosures.

SAN DIEGO – Something as simple as a stamp in a patient’s chart to remind medical providers about vaccinating against human papillomavirus nearly quintupled the percentage of eligible patients being vaccinated in one outpatient office, according to a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The faculty practice was vaccinating only 11% of eligible women before the trial, lower than the 2009 national average vaccination rate of 25%. After the office staff was instructed to place a reminder stamp in the progress notes of all nonpregnant women aged 18-26 years who were scheduled for an appointment with a gynecology provider, the office significantly improved its vaccination rate to 49% of eligible women, Dr. Kerry Rut and her associates reported.

Photo Sherry Boschert/IMNG Medical Mail

The prospective study compared charts for 86 patients who were eligible to receive the Gardasil vaccine for human papillomavirus (HPV) before use of the stamp and 70 patients after implementation of the stamp. Three of the six health care providers in the office (five physicians and a nurse practitioner) significantly increased their vaccinations of patients after the reminder stamp started appearing in progress notes, said Dr. Rut, an ob.gyn. in private practice in Bay Shore, N.Y. She led the study while she was a resident at Winthrop University Hospital, Mineola, N.Y.

The study received top prize among posters presented at the meeting.

Vaccination rates did not seem to be influenced by the reason for the patient’s visit or a history of abnormal Pap smear results. Only the use of the stamp was associated with vaccination rates.

The charts documented that the physician discussed Gardasil in 19 of 86 (22%) cases before use of the stamp and in 63 of 70 (90%) cases after use of the stamp, a significant increase. Still, less than half of eligible patients received the vaccine. When Gardasil was discussed, patients refused vaccination in 34 of 63 (54%) cases. The high refusal rate despite counseling suggests a need to investigate the type of patient education and its content, Dr. Rut suggested.

Patients averaged 23 years of age before use of the stamp and 22 years after the stamp, a statistically significant difference. The two groups did not differ significantly in the type of insurance, the reason for the visit, or the percentage with a previous abnormal Pap smear.

Each of the six medical providers increased their vaccination rates; the increase was statistically significant for three of them. The nurse practitioner had the highest vaccination rate before use of the stamp (4 of 12, or 33%) and after implementation of the stamp (11 of 14, or 79%), a significant increase.

One physician significantly increased vaccination rates from 6% before the stamp (1 of 17 patients) to 62% after the stamp (8 of 13 patients). Another physician significantly improved from vaccinating none of 14 patients before the stamp to 7 of 12 patients after the stamp (58%).

Of the three physicians whose improvement did not reach statistical significance, one went from vaccinating none of 15 patients before the stamp to 1 of 10 patients (10%) after the stamp. Another physician vaccinated 2 of 12 patients at baseline (17%) and 4 of 7 patients after the stamp started (57%). The third physician vaccinated 2 of 16 patients at baseline (13%) and 3 of 14 patients after the stamp (21%).

Overall, the vaccination rate increased from 9 of 86 patients before the stamp (11%) to 34 of 70 patients with use of the stamp (49%), Dr. Rut said.

The stamp included five boxes that the physician could check off: "Start series today," "Series in-progress," "3-vaccine series completed," "Counseled but refuses," and "Other."

As the use of electronic health records increases, perhaps a Gardasil reminder could be incorporated instead of a physical stamp to improve vaccination rates even more, she suggested.

Dr. Rut reported having no relevant financial disclosures.

SAN DIEGO – Something as simple as a stamp in a patient’s chart to remind medical providers about vaccinating against human papillomavirus nearly quintupled the percentage of eligible patients being vaccinated in one outpatient office, according to a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The faculty practice was vaccinating only 11% of eligible women before the trial, lower than the 2009 national average vaccination rate of 25%. After the office staff was instructed to place a reminder stamp in the progress notes of all nonpregnant women aged 18-26 years who were scheduled for an appointment with a gynecology provider, the office significantly improved its vaccination rate to 49% of eligible women, Dr. Kerry Rut and her associates reported.

Photo Sherry Boschert/IMNG Medical Mail

The prospective study compared charts for 86 patients who were eligible to receive the Gardasil vaccine for human papillomavirus (HPV) before use of the stamp and 70 patients after implementation of the stamp. Three of the six health care providers in the office (five physicians and a nurse practitioner) significantly increased their vaccinations of patients after the reminder stamp started appearing in progress notes, said Dr. Rut, an ob.gyn. in private practice in Bay Shore, N.Y. She led the study while she was a resident at Winthrop University Hospital, Mineola, N.Y.

The study received top prize among posters presented at the meeting.

Vaccination rates did not seem to be influenced by the reason for the patient’s visit or a history of abnormal Pap smear results. Only the use of the stamp was associated with vaccination rates.

The charts documented that the physician discussed Gardasil in 19 of 86 (22%) cases before use of the stamp and in 63 of 70 (90%) cases after use of the stamp, a significant increase. Still, less than half of eligible patients received the vaccine. When Gardasil was discussed, patients refused vaccination in 34 of 63 (54%) cases. The high refusal rate despite counseling suggests a need to investigate the type of patient education and its content, Dr. Rut suggested.

Patients averaged 23 years of age before use of the stamp and 22 years after the stamp, a statistically significant difference. The two groups did not differ significantly in the type of insurance, the reason for the visit, or the percentage with a previous abnormal Pap smear.

Each of the six medical providers increased their vaccination rates; the increase was statistically significant for three of them. The nurse practitioner had the highest vaccination rate before use of the stamp (4 of 12, or 33%) and after implementation of the stamp (11 of 14, or 79%), a significant increase.

One physician significantly increased vaccination rates from 6% before the stamp (1 of 17 patients) to 62% after the stamp (8 of 13 patients). Another physician significantly improved from vaccinating none of 14 patients before the stamp to 7 of 12 patients after the stamp (58%).

Of the three physicians whose improvement did not reach statistical significance, one went from vaccinating none of 15 patients before the stamp to 1 of 10 patients (10%) after the stamp. Another physician vaccinated 2 of 12 patients at baseline (17%) and 4 of 7 patients after the stamp started (57%). The third physician vaccinated 2 of 16 patients at baseline (13%) and 3 of 14 patients after the stamp (21%).

Overall, the vaccination rate increased from 9 of 86 patients before the stamp (11%) to 34 of 70 patients with use of the stamp (49%), Dr. Rut said.

The stamp included five boxes that the physician could check off: "Start series today," "Series in-progress," "3-vaccine series completed," "Counseled but refuses," and "Other."

As the use of electronic health records increases, perhaps a Gardasil reminder could be incorporated instead of a physical stamp to improve vaccination rates even more, she suggested.

Dr. Rut reported having no relevant financial disclosures.

BELLEVUE, WASH. – If a child has had abdominal pain for 4-6 weeks without constipation, it’s almost always functional abdominal pain.

That "somewhat bold thesis" explains nearly all childhood abdominal pain, Dr. Tyler Burpee said at the annual meeting of the North Pacific Pediatric Society.

Functional GI disorders, although frequently misdiagnosed, account for 2%-4% of general pediatric visits and more than half of consultations with pediatric gastroenterologists. These patients are suffering, and have lower quality-of-life scores compared with patients who have asthma or migraines, studies have shown.

When patients with functional GI disorders don’t meet criteria for functional dyspepsia, irritable bowel syndrome, or abdominal migraine, they fall into the catch-all diagnostic subcategory of functional abdominal pain, the most common type in children. Diagnostic criteria include continuous or episodic abdominal pain occurring at least weekly for at least 2 months with no evidence of an inflammatory, anatomical, metabolic, or neoplastic process that explains the symptoms.

When parents (and even some physicians) hear the diagnosis of functional abdominal pain, they commonly misinterpret it to mean, "It’s all in your head," said Dr. Burpee, a pediatric gastroenterologist at St. Luke’s Children’s Hospital, Boise, Idaho.

He explains to parents and the child that the transmission of pain from the gut to the brain is incredibly complex, with more nerves in the gut than in the brain or the spinal cord. Functional abdominal pain "means that there’s not something we can see, like an ulcer, but there’s something abnormal happening in the gut," he said.

There’s no cookie-cutter work-up for these patients because their symptoms and characteristics vary so widely, he said. Physicians often order an ultrasound of the abdomen or pelvis, but there’s no evidence that this is helpful in diagnosing functional abdominal pain. The predictive value of blood tests has not been well studied.

Esophagogastroduodenoscopy (EGD) should not be ordered unless the patient exhibits "alarm symptoms," Dr. Burpee said, which can include involuntary weight loss or growth failure, dysphagia, frequent vomiting, chronic and severe diarrhea, nocturnal symptoms (especially bowel movements), persistent right upper quadrant or right lower quadrant pain, or rectal bleeding without constipation. A recent study of 301 patients found that negative EGD results do not improve outcomes with functional GI disorders (Clin. Pediatr. 2011;50:396-401).

There are many useful treatments for functional abdominal pain in children, but antibiotics probably are not on that list. "I don’t think antibiotics are ready for prime time," he said.

Cognitive-behavioral therapy (CBT) and hypnotherapy have the most positive evidence behind them, but other helpful treatments may include peppermint oil, probiotics, the alteration of parenting techniques, and possibly tricyclic antidepressants, placebo pills, or biofeedback.

Parents who tried to distract their child’s attention from abdominal pain made the child feel better than did parents who offered solicitous attention ("Where is the pain? How much does it hurt?") in a prospective study of 223 children with and without functional abdominal pain. In fact, children’s symptom complaints nearly doubled under conditions of parent attention, and were reduced by half under conditions of parent distraction. However, parents in the study feared that the distraction strategy would do more harm than giving attention (Pain 2006;122:43-52).

A separate study of CBT randomized 200 children with functional abdominal pain and their parents to three sessions of either education (the control group) or CBT for training in relaxation, modifying responses to illness/wellness, and altering dysfunctional thoughts about symptoms. Decreases in pain and GI symptoms were significantly greater in the CBT group during 6 months of follow-up. Parents in the CBT group were significantly more likely to decrease their solicitous responses to the child’s symptoms (Am. J. Gastroenterol. 2010;105:946-56).

Hypnotherapy appeared to be astoundingly successful in a study that randomized 51 patients to standard medical therapy or six 50-minute sessions of gut-directed hypnotherapy over a 3-month period. Decreases in the frequency and intensity of abdominal pain were significantly greater in the hypnotherapy group. Rates of clinical remission (defined as at least an 80% decrease in pain intensity and frequency scores) were 25% in the control group and 85% with hypnotherapy – which is "incredible success" in functional abdominal pain, Dr. Burpee said.

The caveat is that the study used one very experienced hypnotherapist, but Seattle Children’s Hospital has begun treating functional abdominal pain and Dr. Burpee has worked with several individual hypnotherapists, both with "incredible success," he said. Hypnotherapy is safe, he added.

Another benign therapy showing promise is peppermint oil. A 2-week period of treatment decreased pain severity by 19% in patients who were randomized to placebo, and by 75% in patients randomized to take enteric-coated peppermint oil capsules (0.2 mL) three times per day, a study of 42 children with irritable bowel syndrome found (J. Pediatr. 2001;138:125-8). The study has limitations, but "it’s a good proof of concept" that also may apply to functional abdominal pain, Dr. Burpee said.

An 8-week period of probiotic therapy with Lactobacillus GG significantly reduced the frequency and severity of abdominal pain, with no significant effects from placebo, in a randomized study of 141 children with irritable bowel syndrome or functional abdominal pain. Benefits persisted for another 8 weeks of follow-up (Pediatrics 2010;126:e1445-52).

There is excellent evidence supporting biofeedback treatment for chronic headaches, and although there are no data for treating abdominal pain, biofeedback seems to work, Dr. Burpee said.

Both amitriptyline and placebo significantly relieved pain and produced a sense of improvement in a 4-week randomized study of 83 children with functional GI disorders. Results did not differ significantly between groups, however, which led the investigators to conclude that both the tricyclic antidepressant and placebo were effective (Gastroenterology 2009;137:1261-9).

"I think most of the things we do with fiber etc. are placebo," Dr. Burpee said. Amitriptyline might be a good choice in a child who has a lot of anxiety around functional abdominal pain, he suggested.

In the latest and probably largest study of antibiotics to treat functional abdominal pain, 1,260 patients were randomized to rifaximin (55 mg three times a day) or placebo for 2 weeks. The proportions of patients who reported relief from pain for at least 2 of the 4 weeks following the start of treatment were 40% with rifaximin and 31% with placebo (N. Engl. J. Med. 2011;364:22-32).

Although the difference between groups was statistically significant, "I’m not really sure of the clinical value of 40% vs. 31% when treating an individual patient," and the antibiotic is very expensive – probably $600 for the treatment course used in the study, Dr. Burpee said.

"Irritable bowel syndrome is not a one-and-done thing," he added, noting that "2 weeks of treatment is probably not a great idea."

There are no great data to support treating functional abdominal pain with acupuncture, Dr. Burpee said. A review of the literature reported about a 30%-40% success rate with real vs. sham acupuncture (Gastroenterol. Clin. North Am. 2011;40:245-53).

Dr. Burpee reported having no relevant financial disclosures.

BELLEVUE, WASH. – If a child has had abdominal pain for 4-6 weeks without constipation, it’s almost always functional abdominal pain.

That "somewhat bold thesis" explains nearly all childhood abdominal pain, Dr. Tyler Burpee said at the annual meeting of the North Pacific Pediatric Society.

Functional GI disorders, although frequently misdiagnosed, account for 2%-4% of general pediatric visits and more than half of consultations with pediatric gastroenterologists. These patients are suffering, and have lower quality-of-life scores compared with patients who have asthma or migraines, studies have shown.

When patients with functional GI disorders don’t meet criteria for functional dyspepsia, irritable bowel syndrome, or abdominal migraine, they fall into the catch-all diagnostic subcategory of functional abdominal pain, the most common type in children. Diagnostic criteria include continuous or episodic abdominal pain occurring at least weekly for at least 2 months with no evidence of an inflammatory, anatomical, metabolic, or neoplastic process that explains the symptoms.

When parents (and even some physicians) hear the diagnosis of functional abdominal pain, they commonly misinterpret it to mean, "It’s all in your head," said Dr. Burpee, a pediatric gastroenterologist at St. Luke’s Children’s Hospital, Boise, Idaho.

He explains to parents and the child that the transmission of pain from the gut to the brain is incredibly complex, with more nerves in the gut than in the brain or the spinal cord. Functional abdominal pain "means that there’s not something we can see, like an ulcer, but there’s something abnormal happening in the gut," he said.

There’s no cookie-cutter work-up for these patients because their symptoms and characteristics vary so widely, he said. Physicians often order an ultrasound of the abdomen or pelvis, but there’s no evidence that this is helpful in diagnosing functional abdominal pain. The predictive value of blood tests has not been well studied.

Esophagogastroduodenoscopy (EGD) should not be ordered unless the patient exhibits "alarm symptoms," Dr. Burpee said, which can include involuntary weight loss or growth failure, dysphagia, frequent vomiting, chronic and severe diarrhea, nocturnal symptoms (especially bowel movements), persistent right upper quadrant or right lower quadrant pain, or rectal bleeding without constipation. A recent study of 301 patients found that negative EGD results do not improve outcomes with functional GI disorders (Clin. Pediatr. 2011;50:396-401).

There are many useful treatments for functional abdominal pain in children, but antibiotics probably are not on that list. "I don’t think antibiotics are ready for prime time," he said.

Cognitive-behavioral therapy (CBT) and hypnotherapy have the most positive evidence behind them, but other helpful treatments may include peppermint oil, probiotics, the alteration of parenting techniques, and possibly tricyclic antidepressants, placebo pills, or biofeedback.

Parents who tried to distract their child’s attention from abdominal pain made the child feel better than did parents who offered solicitous attention ("Where is the pain? How much does it hurt?") in a prospective study of 223 children with and without functional abdominal pain. In fact, children’s symptom complaints nearly doubled under conditions of parent attention, and were reduced by half under conditions of parent distraction. However, parents in the study feared that the distraction strategy would do more harm than giving attention (Pain 2006;122:43-52).

A separate study of CBT randomized 200 children with functional abdominal pain and their parents to three sessions of either education (the control group) or CBT for training in relaxation, modifying responses to illness/wellness, and altering dysfunctional thoughts about symptoms. Decreases in pain and GI symptoms were significantly greater in the CBT group during 6 months of follow-up. Parents in the CBT group were significantly more likely to decrease their solicitous responses to the child’s symptoms (Am. J. Gastroenterol. 2010;105:946-56).

Hypnotherapy appeared to be astoundingly successful in a study that randomized 51 patients to standard medical therapy or six 50-minute sessions of gut-directed hypnotherapy over a 3-month period. Decreases in the frequency and intensity of abdominal pain were significantly greater in the hypnotherapy group. Rates of clinical remission (defined as at least an 80% decrease in pain intensity and frequency scores) were 25% in the control group and 85% with hypnotherapy – which is "incredible success" in functional abdominal pain, Dr. Burpee said.

The caveat is that the study used one very experienced hypnotherapist, but Seattle Children’s Hospital has begun treating functional abdominal pain and Dr. Burpee has worked with several individual hypnotherapists, both with "incredible success," he said. Hypnotherapy is safe, he added.

Another benign therapy showing promise is peppermint oil. A 2-week period of treatment decreased pain severity by 19% in patients who were randomized to placebo, and by 75% in patients randomized to take enteric-coated peppermint oil capsules (0.2 mL) three times per day, a study of 42 children with irritable bowel syndrome found (J. Pediatr. 2001;138:125-8). The study has limitations, but "it’s a good proof of concept" that also may apply to functional abdominal pain, Dr. Burpee said.

An 8-week period of probiotic therapy with Lactobacillus GG significantly reduced the frequency and severity of abdominal pain, with no significant effects from placebo, in a randomized study of 141 children with irritable bowel syndrome or functional abdominal pain. Benefits persisted for another 8 weeks of follow-up (Pediatrics 2010;126:e1445-52).

There is excellent evidence supporting biofeedback treatment for chronic headaches, and although there are no data for treating abdominal pain, biofeedback seems to work, Dr. Burpee said.

Both amitriptyline and placebo significantly relieved pain and produced a sense of improvement in a 4-week randomized study of 83 children with functional GI disorders. Results did not differ significantly between groups, however, which led the investigators to conclude that both the tricyclic antidepressant and placebo were effective (Gastroenterology 2009;137:1261-9).

"I think most of the things we do with fiber etc. are placebo," Dr. Burpee said. Amitriptyline might be a good choice in a child who has a lot of anxiety around functional abdominal pain, he suggested.

In the latest and probably largest study of antibiotics to treat functional abdominal pain, 1,260 patients were randomized to rifaximin (55 mg three times a day) or placebo for 2 weeks. The proportions of patients who reported relief from pain for at least 2 of the 4 weeks following the start of treatment were 40% with rifaximin and 31% with placebo (N. Engl. J. Med. 2011;364:22-32).

Although the difference between groups was statistically significant, "I’m not really sure of the clinical value of 40% vs. 31% when treating an individual patient," and the antibiotic is very expensive – probably $600 for the treatment course used in the study, Dr. Burpee said.

"Irritable bowel syndrome is not a one-and-done thing," he added, noting that "2 weeks of treatment is probably not a great idea."

There are no great data to support treating functional abdominal pain with acupuncture, Dr. Burpee said. A review of the literature reported about a 30%-40% success rate with real vs. sham acupuncture (Gastroenterol. Clin. North Am. 2011;40:245-53).

Dr. Burpee reported having no relevant financial disclosures.

BELLEVUE, WASH. – If a child has had abdominal pain for 4-6 weeks without constipation, it’s almost always functional abdominal pain.

That "somewhat bold thesis" explains nearly all childhood abdominal pain, Dr. Tyler Burpee said at the annual meeting of the North Pacific Pediatric Society.

Functional GI disorders, although frequently misdiagnosed, account for 2%-4% of general pediatric visits and more than half of consultations with pediatric gastroenterologists. These patients are suffering, and have lower quality-of-life scores compared with patients who have asthma or migraines, studies have shown.

When patients with functional GI disorders don’t meet criteria for functional dyspepsia, irritable bowel syndrome, or abdominal migraine, they fall into the catch-all diagnostic subcategory of functional abdominal pain, the most common type in children. Diagnostic criteria include continuous or episodic abdominal pain occurring at least weekly for at least 2 months with no evidence of an inflammatory, anatomical, metabolic, or neoplastic process that explains the symptoms.

When parents (and even some physicians) hear the diagnosis of functional abdominal pain, they commonly misinterpret it to mean, "It’s all in your head," said Dr. Burpee, a pediatric gastroenterologist at St. Luke’s Children’s Hospital, Boise, Idaho.

He explains to parents and the child that the transmission of pain from the gut to the brain is incredibly complex, with more nerves in the gut than in the brain or the spinal cord. Functional abdominal pain "means that there’s not something we can see, like an ulcer, but there’s something abnormal happening in the gut," he said.

There’s no cookie-cutter work-up for these patients because their symptoms and characteristics vary so widely, he said. Physicians often order an ultrasound of the abdomen or pelvis, but there’s no evidence that this is helpful in diagnosing functional abdominal pain. The predictive value of blood tests has not been well studied.

Esophagogastroduodenoscopy (EGD) should not be ordered unless the patient exhibits "alarm symptoms," Dr. Burpee said, which can include involuntary weight loss or growth failure, dysphagia, frequent vomiting, chronic and severe diarrhea, nocturnal symptoms (especially bowel movements), persistent right upper quadrant or right lower quadrant pain, or rectal bleeding without constipation. A recent study of 301 patients found that negative EGD results do not improve outcomes with functional GI disorders (Clin. Pediatr. 2011;50:396-401).

There are many useful treatments for functional abdominal pain in children, but antibiotics probably are not on that list. "I don’t think antibiotics are ready for prime time," he said.

Cognitive-behavioral therapy (CBT) and hypnotherapy have the most positive evidence behind them, but other helpful treatments may include peppermint oil, probiotics, the alteration of parenting techniques, and possibly tricyclic antidepressants, placebo pills, or biofeedback.

Parents who tried to distract their child’s attention from abdominal pain made the child feel better than did parents who offered solicitous attention ("Where is the pain? How much does it hurt?") in a prospective study of 223 children with and without functional abdominal pain. In fact, children’s symptom complaints nearly doubled under conditions of parent attention, and were reduced by half under conditions of parent distraction. However, parents in the study feared that the distraction strategy would do more harm than giving attention (Pain 2006;122:43-52).

A separate study of CBT randomized 200 children with functional abdominal pain and their parents to three sessions of either education (the control group) or CBT for training in relaxation, modifying responses to illness/wellness, and altering dysfunctional thoughts about symptoms. Decreases in pain and GI symptoms were significantly greater in the CBT group during 6 months of follow-up. Parents in the CBT group were significantly more likely to decrease their solicitous responses to the child’s symptoms (Am. J. Gastroenterol. 2010;105:946-56).

Hypnotherapy appeared to be astoundingly successful in a study that randomized 51 patients to standard medical therapy or six 50-minute sessions of gut-directed hypnotherapy over a 3-month period. Decreases in the frequency and intensity of abdominal pain were significantly greater in the hypnotherapy group. Rates of clinical remission (defined as at least an 80% decrease in pain intensity and frequency scores) were 25% in the control group and 85% with hypnotherapy – which is "incredible success" in functional abdominal pain, Dr. Burpee said.

The caveat is that the study used one very experienced hypnotherapist, but Seattle Children’s Hospital has begun treating functional abdominal pain and Dr. Burpee has worked with several individual hypnotherapists, both with "incredible success," he said. Hypnotherapy is safe, he added.

Another benign therapy showing promise is peppermint oil. A 2-week period of treatment decreased pain severity by 19% in patients who were randomized to placebo, and by 75% in patients randomized to take enteric-coated peppermint oil capsules (0.2 mL) three times per day, a study of 42 children with irritable bowel syndrome found (J. Pediatr. 2001;138:125-8). The study has limitations, but "it’s a good proof of concept" that also may apply to functional abdominal pain, Dr. Burpee said.

An 8-week period of probiotic therapy with Lactobacillus GG significantly reduced the frequency and severity of abdominal pain, with no significant effects from placebo, in a randomized study of 141 children with irritable bowel syndrome or functional abdominal pain. Benefits persisted for another 8 weeks of follow-up (Pediatrics 2010;126:e1445-52).

There is excellent evidence supporting biofeedback treatment for chronic headaches, and although there are no data for treating abdominal pain, biofeedback seems to work, Dr. Burpee said.

Both amitriptyline and placebo significantly relieved pain and produced a sense of improvement in a 4-week randomized study of 83 children with functional GI disorders. Results did not differ significantly between groups, however, which led the investigators to conclude that both the tricyclic antidepressant and placebo were effective (Gastroenterology 2009;137:1261-9).

"I think most of the things we do with fiber etc. are placebo," Dr. Burpee said. Amitriptyline might be a good choice in a child who has a lot of anxiety around functional abdominal pain, he suggested.

In the latest and probably largest study of antibiotics to treat functional abdominal pain, 1,260 patients were randomized to rifaximin (55 mg three times a day) or placebo for 2 weeks. The proportions of patients who reported relief from pain for at least 2 of the 4 weeks following the start of treatment were 40% with rifaximin and 31% with placebo (N. Engl. J. Med. 2011;364:22-32).

Although the difference between groups was statistically significant, "I’m not really sure of the clinical value of 40% vs. 31% when treating an individual patient," and the antibiotic is very expensive – probably $600 for the treatment course used in the study, Dr. Burpee said.

"Irritable bowel syndrome is not a one-and-done thing," he added, noting that "2 weeks of treatment is probably not a great idea."

There are no great data to support treating functional abdominal pain with acupuncture, Dr. Burpee said. A review of the literature reported about a 30%-40% success rate with real vs. sham acupuncture (Gastroenterol. Clin. North Am. 2011;40:245-53).

Dr. Burpee reported having no relevant financial disclosures.

BELLEVUE, WASH. – Talking with your teenage patients is important, but don’t forget to examine their bodies.

"We spend so much time talking to them, we don’t put on our medical provider hats and actually verify that things are okay and that they’re on the right growth trajectory," Dr. Cora C. Breuner said at a conference sponsored by the North Pacific Pediatric Society. When that happens, "we miss things."

Lots of girls have asymmetrical breasts and are very concerned about it, but don’t know how to ask a physician about it. Lots of boys have gynecomastia, are very embarrassed about it, and don’t know how to talk about it. For the 10%-30% of boys who are uncircumcised (depending on the population), chances are that no one is talking to them about how to clean the penis.

"You can normalize so much during their physical exam when you do the exam yourself," said Dr. Breuner, professor of pediatrics and adolescent medicine at the University of Washington, Seattle.

Some physicians skip the exam or have another provider do it because they feel pressured for time. Others don’t want to make the patient uncomfortable by examining everything including genitals, or the patient refuses to undress. Have a chaperone present during physical exams if you need to, "but do your exams," she stressed. "You can catch things that no one else will note."

Especially for sports physical exams, there’s no way to know if boys have matured physically enough to play contact sports without examining development of the genitals and pubic hair. With girls, if they have reached menarche, they’re probably a Tanner stage IV in terms of their epiphysis (growth plates) being closed, making them eligible for contact sports. Either sex may balk at the idea of a physical exam.

"Too bad. It’s our job," Dr. Breuner said.

She explains to boys that she needs to do a complete exam and that she will just look at their penis and testicles to make sure everything is okay. The usual response is a grumbly, "I’m not doing that. No way."

Dr. Breuner uses a tried-and-true script that gets boys to agree to a physical exam. She says to them, "You know what? I can actually tell if you’re going to be any taller by just doing an exam. I can tell whether you are finished with your height, or whether you still have 4 to 6 more inches to grow."

"You can normalize so much during their physical exam when you do the exam yourself."

She’s always amazed at how that eases the process. The exam takes a few seconds, and as she’s washing her hands and the boy is putting his pants back on, she may tell them that they’re not at all done with their height trajectory.

"They’re so reassured, because they haven’t been able to talk to anyone about this, and they’re so afraid someone’s going to say that something is wrong," Dr. Breuner said.

Peak adolescent growth spurts tend to happen 2 years later in boys than in girls (typically at ages 14-16 years for boys and 12-14 years for girls), feeding their anxiety about this. Growth still may be possible for boys in their last year of high school or first year of college, but generally is finished in girls by the time they’re 16 years old. The timing of genital changes also tends to occur 2 years later in boys than in girls. Some girls may develop breasts as early as 8 years of age and others not until they’re 13, but both are normal. Menarche normally occurs between ages 10 and 16.5 years, she said.

Despite guidelines recommending annual physical exams for adolescents, physicians often only get to see them for annual sports physicals or for vaccinations. Seize the opportunity to cover some adolescent health supervision, Dr. Breuner urged.

"It’s really important to spend some time on the social aspect as well as the physical," she said. The top three causes of death in adolescents are motor vehicle accidents, suicides, and homicides.

At the very least, repeatedly give them a three-point message, she suggested: "Don’t drink and drive. Don’t text and drive. Here’s your vaccine."

Dr. Breuner reported having no relevant financial disclosures.

BELLEVUE, WASH. – Talking with your teenage patients is important, but don’t forget to examine their bodies.

"We spend so much time talking to them, we don’t put on our medical provider hats and actually verify that things are okay and that they’re on the right growth trajectory," Dr. Cora C. Breuner said at a conference sponsored by the North Pacific Pediatric Society. When that happens, "we miss things."

Lots of girls have asymmetrical breasts and are very concerned about it, but don’t know how to ask a physician about it. Lots of boys have gynecomastia, are very embarrassed about it, and don’t know how to talk about it. For the 10%-30% of boys who are uncircumcised (depending on the population), chances are that no one is talking to them about how to clean the penis.

"You can normalize so much during their physical exam when you do the exam yourself," said Dr. Breuner, professor of pediatrics and adolescent medicine at the University of Washington, Seattle.

Some physicians skip the exam or have another provider do it because they feel pressured for time. Others don’t want to make the patient uncomfortable by examining everything including genitals, or the patient refuses to undress. Have a chaperone present during physical exams if you need to, "but do your exams," she stressed. "You can catch things that no one else will note."

Especially for sports physical exams, there’s no way to know if boys have matured physically enough to play contact sports without examining development of the genitals and pubic hair. With girls, if they have reached menarche, they’re probably a Tanner stage IV in terms of their epiphysis (growth plates) being closed, making them eligible for contact sports. Either sex may balk at the idea of a physical exam.

"Too bad. It’s our job," Dr. Breuner said.

She explains to boys that she needs to do a complete exam and that she will just look at their penis and testicles to make sure everything is okay. The usual response is a grumbly, "I’m not doing that. No way."

Dr. Breuner uses a tried-and-true script that gets boys to agree to a physical exam. She says to them, "You know what? I can actually tell if you’re going to be any taller by just doing an exam. I can tell whether you are finished with your height, or whether you still have 4 to 6 more inches to grow."

"You can normalize so much during their physical exam when you do the exam yourself."

She’s always amazed at how that eases the process. The exam takes a few seconds, and as she’s washing her hands and the boy is putting his pants back on, she may tell them that they’re not at all done with their height trajectory.

"They’re so reassured, because they haven’t been able to talk to anyone about this, and they’re so afraid someone’s going to say that something is wrong," Dr. Breuner said.

Peak adolescent growth spurts tend to happen 2 years later in boys than in girls (typically at ages 14-16 years for boys and 12-14 years for girls), feeding their anxiety about this. Growth still may be possible for boys in their last year of high school or first year of college, but generally is finished in girls by the time they’re 16 years old. The timing of genital changes also tends to occur 2 years later in boys than in girls. Some girls may develop breasts as early as 8 years of age and others not until they’re 13, but both are normal. Menarche normally occurs between ages 10 and 16.5 years, she said.

Despite guidelines recommending annual physical exams for adolescents, physicians often only get to see them for annual sports physicals or for vaccinations. Seize the opportunity to cover some adolescent health supervision, Dr. Breuner urged.

"It’s really important to spend some time on the social aspect as well as the physical," she said. The top three causes of death in adolescents are motor vehicle accidents, suicides, and homicides.

At the very least, repeatedly give them a three-point message, she suggested: "Don’t drink and drive. Don’t text and drive. Here’s your vaccine."

Dr. Breuner reported having no relevant financial disclosures.

BELLEVUE, WASH. – Talking with your teenage patients is important, but don’t forget to examine their bodies.

"We spend so much time talking to them, we don’t put on our medical provider hats and actually verify that things are okay and that they’re on the right growth trajectory," Dr. Cora C. Breuner said at a conference sponsored by the North Pacific Pediatric Society. When that happens, "we miss things."

Lots of girls have asymmetrical breasts and are very concerned about it, but don’t know how to ask a physician about it. Lots of boys have gynecomastia, are very embarrassed about it, and don’t know how to talk about it. For the 10%-30% of boys who are uncircumcised (depending on the population), chances are that no one is talking to them about how to clean the penis.

"You can normalize so much during their physical exam when you do the exam yourself," said Dr. Breuner, professor of pediatrics and adolescent medicine at the University of Washington, Seattle.

Some physicians skip the exam or have another provider do it because they feel pressured for time. Others don’t want to make the patient uncomfortable by examining everything including genitals, or the patient refuses to undress. Have a chaperone present during physical exams if you need to, "but do your exams," she stressed. "You can catch things that no one else will note."

Especially for sports physical exams, there’s no way to know if boys have matured physically enough to play contact sports without examining development of the genitals and pubic hair. With girls, if they have reached menarche, they’re probably a Tanner stage IV in terms of their epiphysis (growth plates) being closed, making them eligible for contact sports. Either sex may balk at the idea of a physical exam.

"Too bad. It’s our job," Dr. Breuner said.

She explains to boys that she needs to do a complete exam and that she will just look at their penis and testicles to make sure everything is okay. The usual response is a grumbly, "I’m not doing that. No way."

Dr. Breuner uses a tried-and-true script that gets boys to agree to a physical exam. She says to them, "You know what? I can actually tell if you’re going to be any taller by just doing an exam. I can tell whether you are finished with your height, or whether you still have 4 to 6 more inches to grow."

"You can normalize so much during their physical exam when you do the exam yourself."

She’s always amazed at how that eases the process. The exam takes a few seconds, and as she’s washing her hands and the boy is putting his pants back on, she may tell them that they’re not at all done with their height trajectory.

"They’re so reassured, because they haven’t been able to talk to anyone about this, and they’re so afraid someone’s going to say that something is wrong," Dr. Breuner said.

Peak adolescent growth spurts tend to happen 2 years later in boys than in girls (typically at ages 14-16 years for boys and 12-14 years for girls), feeding their anxiety about this. Growth still may be possible for boys in their last year of high school or first year of college, but generally is finished in girls by the time they’re 16 years old. The timing of genital changes also tends to occur 2 years later in boys than in girls. Some girls may develop breasts as early as 8 years of age and others not until they’re 13, but both are normal. Menarche normally occurs between ages 10 and 16.5 years, she said.

Despite guidelines recommending annual physical exams for adolescents, physicians often only get to see them for annual sports physicals or for vaccinations. Seize the opportunity to cover some adolescent health supervision, Dr. Breuner urged.

"It’s really important to spend some time on the social aspect as well as the physical," she said. The top three causes of death in adolescents are motor vehicle accidents, suicides, and homicides.

At the very least, repeatedly give them a three-point message, she suggested: "Don’t drink and drive. Don’t text and drive. Here’s your vaccine."

Dr. Breuner reported having no relevant financial disclosures.

SAN DIEGO – Almost half of women undergoing a medical abortion could safely avoid an in-person follow-up visit by using phone follow-ups, a review of charts on 118 women suggests.

A typical protocol for medical abortion involves taking 200 mg of oral mifepristone, then 800 mcg of vaginal or buccal misoprostol, with an in-office follow-up visit a week later for a transvaginal ultrasound to make sure the abortion is complete. This study offered alternative follow-up by phone to women in a clinical practice at Magee-Women’s Hospital in Pittsburgh from Jan. 2010 through June 2011.

Phone follow-up included conducting a phone survey at 1 week and having the women perform a urine pregnancy test at 1 month so they could report the results when they were contacted in a 1-month follow-up phone call. Women with a positive urine pregnancy test were asked to return to the office for an ultrasound.

Overall, 44% of the 51 women who chose phone follow-up did not require office visits, Diana W. Samberg and Dr. Beatrice A. Chen reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The proportion of women who were lost to follow-up did not differ significantly between the phone follow-up group (9 of 51 women, or 18%) and the office follow-up group (6 of 67 women, or 9%), reported Ms. Samberg and Dr. Chen of the University of Pittsburgh, where Ms. Samberg is a medical student.

The two groups also did not differ significantly in rates of adverse events, which were seen in 24% of the phone group and 17% of the office group. Among individual adverse events, the phone group was more likely to report heavy bleeding (14% vs. 3%) and to request an office visit for that reason. (Heavy bleeding was defined as any bleeding requiring an office visit.) Other adverse events included minimal bleeding, blood transfusion, emergency department visits, incomplete abortion, additional procedures, heavy pain, and allergic reaction. No women developed infection.

The trade-off for fewer office visits in the phone group was more phone calls. The phone group was significantly more likely to make unscheduled phone calls or office visits; some 55% in the phone group and 39% in the office group made unscheduled contacts. Two or more unscheduled contacts were made by 41% in the phone group and 20% in the office group.

In the phone follow-up group, the reasons for not being followed exclusively by phone (other than being lost to follow-up) included a switch by some women to office follow-up before the 1-week phone call; requests by some women to be seen in the office after the 1-week phone call even though the physician didn’t consider it necessary; and visits by some women before the 30-day call to medical clinics or the emergency department, during which follow-up or pregnancy tests were performed.

Among seven women who were advised to come to the office after the 1-week phone call, three required an additional procedure (either misoprostol or a D&C). Among women who were followed by phone at 30 days, three were advised to come to the office based on their positive urine pregnancy test, but only one required a D&C.

"Phone follow-up is feasible for medical abortion and can assess the need for further in-person follow-up," Ms. Samberg said.

The women who chose phone follow-up were significantly older (32 years on average), compared with 27 years in the office group. Women in the phone group were significantly more likely than those in the office group to have had a previous pregnancy (88% vs. 61%) and to have had a prior therapeutic abortion (51% vs. 30%). Parity did not differ significantly between groups. Women choosing phone follow-up were significantly more likely to be white and employed.

The findings follow a 2010 pilot study with 139 women that supported the feasibility of phone follow-up, in which 64% did not require in-person office follow-up (Contraception 2010;81:143-9), Ms. Samberg said.

Doing a urine pregnancy test and taking a good history are among alternatives that have been suggested as a means to avoid some ultrasounds and potentially improve follow-up compliance after medical abortions. Testing serum levels of beta–human chorionic gonadotropin also has been suggested as an alternative.

Ms. Samberg reported having no financial disclosures. Dr. Chen has received research support from Bayer Pharmaceuticals, Medicines360, Agile Therapeutics, and Evofem Inc. 

SAN DIEGO – Almost half of women undergoing a medical abortion could safely avoid an in-person follow-up visit by using phone follow-ups, a review of charts on 118 women suggests.

A typical protocol for medical abortion involves taking 200 mg of oral mifepristone, then 800 mcg of vaginal or buccal misoprostol, with an in-office follow-up visit a week later for a transvaginal ultrasound to make sure the abortion is complete. This study offered alternative follow-up by phone to women in a clinical practice at Magee-Women’s Hospital in Pittsburgh from Jan. 2010 through June 2011.

Phone follow-up included conducting a phone survey at 1 week and having the women perform a urine pregnancy test at 1 month so they could report the results when they were contacted in a 1-month follow-up phone call. Women with a positive urine pregnancy test were asked to return to the office for an ultrasound.

Overall, 44% of the 51 women who chose phone follow-up did not require office visits, Diana W. Samberg and Dr. Beatrice A. Chen reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The proportion of women who were lost to follow-up did not differ significantly between the phone follow-up group (9 of 51 women, or 18%) and the office follow-up group (6 of 67 women, or 9%), reported Ms. Samberg and Dr. Chen of the University of Pittsburgh, where Ms. Samberg is a medical student.

The two groups also did not differ significantly in rates of adverse events, which were seen in 24% of the phone group and 17% of the office group. Among individual adverse events, the phone group was more likely to report heavy bleeding (14% vs. 3%) and to request an office visit for that reason. (Heavy bleeding was defined as any bleeding requiring an office visit.) Other adverse events included minimal bleeding, blood transfusion, emergency department visits, incomplete abortion, additional procedures, heavy pain, and allergic reaction. No women developed infection.

The trade-off for fewer office visits in the phone group was more phone calls. The phone group was significantly more likely to make unscheduled phone calls or office visits; some 55% in the phone group and 39% in the office group made unscheduled contacts. Two or more unscheduled contacts were made by 41% in the phone group and 20% in the office group.

In the phone follow-up group, the reasons for not being followed exclusively by phone (other than being lost to follow-up) included a switch by some women to office follow-up before the 1-week phone call; requests by some women to be seen in the office after the 1-week phone call even though the physician didn’t consider it necessary; and visits by some women before the 30-day call to medical clinics or the emergency department, during which follow-up or pregnancy tests were performed.

Among seven women who were advised to come to the office after the 1-week phone call, three required an additional procedure (either misoprostol or a D&C). Among women who were followed by phone at 30 days, three were advised to come to the office based on their positive urine pregnancy test, but only one required a D&C.

"Phone follow-up is feasible for medical abortion and can assess the need for further in-person follow-up," Ms. Samberg said.

The women who chose phone follow-up were significantly older (32 years on average), compared with 27 years in the office group. Women in the phone group were significantly more likely than those in the office group to have had a previous pregnancy (88% vs. 61%) and to have had a prior therapeutic abortion (51% vs. 30%). Parity did not differ significantly between groups. Women choosing phone follow-up were significantly more likely to be white and employed.

The findings follow a 2010 pilot study with 139 women that supported the feasibility of phone follow-up, in which 64% did not require in-person office follow-up (Contraception 2010;81:143-9), Ms. Samberg said.

Doing a urine pregnancy test and taking a good history are among alternatives that have been suggested as a means to avoid some ultrasounds and potentially improve follow-up compliance after medical abortions. Testing serum levels of beta–human chorionic gonadotropin also has been suggested as an alternative.

Ms. Samberg reported having no financial disclosures. Dr. Chen has received research support from Bayer Pharmaceuticals, Medicines360, Agile Therapeutics, and Evofem Inc. 

SAN DIEGO – Almost half of women undergoing a medical abortion could safely avoid an in-person follow-up visit by using phone follow-ups, a review of charts on 118 women suggests.

A typical protocol for medical abortion involves taking 200 mg of oral mifepristone, then 800 mcg of vaginal or buccal misoprostol, with an in-office follow-up visit a week later for a transvaginal ultrasound to make sure the abortion is complete. This study offered alternative follow-up by phone to women in a clinical practice at Magee-Women’s Hospital in Pittsburgh from Jan. 2010 through June 2011.

Phone follow-up included conducting a phone survey at 1 week and having the women perform a urine pregnancy test at 1 month so they could report the results when they were contacted in a 1-month follow-up phone call. Women with a positive urine pregnancy test were asked to return to the office for an ultrasound.

Overall, 44% of the 51 women who chose phone follow-up did not require office visits, Diana W. Samberg and Dr. Beatrice A. Chen reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The proportion of women who were lost to follow-up did not differ significantly between the phone follow-up group (9 of 51 women, or 18%) and the office follow-up group (6 of 67 women, or 9%), reported Ms. Samberg and Dr. Chen of the University of Pittsburgh, where Ms. Samberg is a medical student.

The two groups also did not differ significantly in rates of adverse events, which were seen in 24% of the phone group and 17% of the office group. Among individual adverse events, the phone group was more likely to report heavy bleeding (14% vs. 3%) and to request an office visit for that reason. (Heavy bleeding was defined as any bleeding requiring an office visit.) Other adverse events included minimal bleeding, blood transfusion, emergency department visits, incomplete abortion, additional procedures, heavy pain, and allergic reaction. No women developed infection.

The trade-off for fewer office visits in the phone group was more phone calls. The phone group was significantly more likely to make unscheduled phone calls or office visits; some 55% in the phone group and 39% in the office group made unscheduled contacts. Two or more unscheduled contacts were made by 41% in the phone group and 20% in the office group.

In the phone follow-up group, the reasons for not being followed exclusively by phone (other than being lost to follow-up) included a switch by some women to office follow-up before the 1-week phone call; requests by some women to be seen in the office after the 1-week phone call even though the physician didn’t consider it necessary; and visits by some women before the 30-day call to medical clinics or the emergency department, during which follow-up or pregnancy tests were performed.

Among seven women who were advised to come to the office after the 1-week phone call, three required an additional procedure (either misoprostol or a D&C). Among women who were followed by phone at 30 days, three were advised to come to the office based on their positive urine pregnancy test, but only one required a D&C.

"Phone follow-up is feasible for medical abortion and can assess the need for further in-person follow-up," Ms. Samberg said.

The women who chose phone follow-up were significantly older (32 years on average), compared with 27 years in the office group. Women in the phone group were significantly more likely than those in the office group to have had a previous pregnancy (88% vs. 61%) and to have had a prior therapeutic abortion (51% vs. 30%). Parity did not differ significantly between groups. Women choosing phone follow-up were significantly more likely to be white and employed.

The findings follow a 2010 pilot study with 139 women that supported the feasibility of phone follow-up, in which 64% did not require in-person office follow-up (Contraception 2010;81:143-9), Ms. Samberg said.

Doing a urine pregnancy test and taking a good history are among alternatives that have been suggested as a means to avoid some ultrasounds and potentially improve follow-up compliance after medical abortions. Testing serum levels of beta–human chorionic gonadotropin also has been suggested as an alternative.

Ms. Samberg reported having no financial disclosures. Dr. Chen has received research support from Bayer Pharmaceuticals, Medicines360, Agile Therapeutics, and Evofem Inc.