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CMS pilot aims to reduce physician administrative burdens
Officials at the Centers for Medicare & Medicaid Services are launching a new initiative aimed at reducing administrative burdens for physicians who participate in certain value-based payment models.
Under an 18-month pilot, providers practicing within certain Advanced Alternative Payment Models (Advanced APMs) will be relieved of additional documentation scrutiny under Medicare medical review programs, according to an Oct. 13 CMS announcement. As part of the effort, the agency will direct Medicare Administrative Contractors and Recovery Audit Contractors to consider doctors participating in Advanced APMs as a low-priority for postpayment claim reviews.
“As we implement the Quality Payment Program under [the Medicare Access and CHIP Reauthorization Act of 2015], we cannot do it without making a sustained, long-term commitment to take a holistic view on the demands on the physician and clinician workforce,” Mr. Slavitt said in a statement. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do – taking care of patients.”
The pilot will have two phases, beginning in early 2017, and will include Advanced APMs, Next Generation Accountable Care Organizations, Medicare Shared Savings Program Track 2 and Track 3 participants, Pioneer Accountable Care Organizations, and Oncology Care Model two-sided track participants.
As part of the program, clinicians will be engaged in regional discussions with CMS regarding documentation requirements and their interactions with the agency. To that end, each of the 10 CMS regional offices will oversee local meetings to gather feedback from physician practices within the next 6 months and conduct regular meetings thereafter. The local meetings will result in a report with targeted recommendations to the CMS Administrator in 2017.
The American Medical Association praised the effort to reduce regulatory burdens.
The American College of Physicians also applauded the initiative, but said the initiative should be expanded to include other advanced APMs, such as the Comprehensive Primary Care Plus program, Nitin S. Damle, MD, the college’s president, said in a statement.
“It is critical to us that this initiative be conducted in addition to – not in lieu of – other needed reforms to reduce burdensome administrative tasks and simplify MACRA implementation,” Dr. Damle said.
[email protected]
On Twitter @legal_med
Officials at the Centers for Medicare & Medicaid Services are launching a new initiative aimed at reducing administrative burdens for physicians who participate in certain value-based payment models.
Under an 18-month pilot, providers practicing within certain Advanced Alternative Payment Models (Advanced APMs) will be relieved of additional documentation scrutiny under Medicare medical review programs, according to an Oct. 13 CMS announcement. As part of the effort, the agency will direct Medicare Administrative Contractors and Recovery Audit Contractors to consider doctors participating in Advanced APMs as a low-priority for postpayment claim reviews.
“As we implement the Quality Payment Program under [the Medicare Access and CHIP Reauthorization Act of 2015], we cannot do it without making a sustained, long-term commitment to take a holistic view on the demands on the physician and clinician workforce,” Mr. Slavitt said in a statement. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do – taking care of patients.”
The pilot will have two phases, beginning in early 2017, and will include Advanced APMs, Next Generation Accountable Care Organizations, Medicare Shared Savings Program Track 2 and Track 3 participants, Pioneer Accountable Care Organizations, and Oncology Care Model two-sided track participants.
As part of the program, clinicians will be engaged in regional discussions with CMS regarding documentation requirements and their interactions with the agency. To that end, each of the 10 CMS regional offices will oversee local meetings to gather feedback from physician practices within the next 6 months and conduct regular meetings thereafter. The local meetings will result in a report with targeted recommendations to the CMS Administrator in 2017.
The American Medical Association praised the effort to reduce regulatory burdens.
The American College of Physicians also applauded the initiative, but said the initiative should be expanded to include other advanced APMs, such as the Comprehensive Primary Care Plus program, Nitin S. Damle, MD, the college’s president, said in a statement.
“It is critical to us that this initiative be conducted in addition to – not in lieu of – other needed reforms to reduce burdensome administrative tasks and simplify MACRA implementation,” Dr. Damle said.
[email protected]
On Twitter @legal_med
Officials at the Centers for Medicare & Medicaid Services are launching a new initiative aimed at reducing administrative burdens for physicians who participate in certain value-based payment models.
Under an 18-month pilot, providers practicing within certain Advanced Alternative Payment Models (Advanced APMs) will be relieved of additional documentation scrutiny under Medicare medical review programs, according to an Oct. 13 CMS announcement. As part of the effort, the agency will direct Medicare Administrative Contractors and Recovery Audit Contractors to consider doctors participating in Advanced APMs as a low-priority for postpayment claim reviews.
“As we implement the Quality Payment Program under [the Medicare Access and CHIP Reauthorization Act of 2015], we cannot do it without making a sustained, long-term commitment to take a holistic view on the demands on the physician and clinician workforce,” Mr. Slavitt said in a statement. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do – taking care of patients.”
The pilot will have two phases, beginning in early 2017, and will include Advanced APMs, Next Generation Accountable Care Organizations, Medicare Shared Savings Program Track 2 and Track 3 participants, Pioneer Accountable Care Organizations, and Oncology Care Model two-sided track participants.
As part of the program, clinicians will be engaged in regional discussions with CMS regarding documentation requirements and their interactions with the agency. To that end, each of the 10 CMS regional offices will oversee local meetings to gather feedback from physician practices within the next 6 months and conduct regular meetings thereafter. The local meetings will result in a report with targeted recommendations to the CMS Administrator in 2017.
The American Medical Association praised the effort to reduce regulatory burdens.
The American College of Physicians also applauded the initiative, but said the initiative should be expanded to include other advanced APMs, such as the Comprehensive Primary Care Plus program, Nitin S. Damle, MD, the college’s president, said in a statement.
“It is critical to us that this initiative be conducted in addition to – not in lieu of – other needed reforms to reduce burdensome administrative tasks and simplify MACRA implementation,” Dr. Damle said.
[email protected]
On Twitter @legal_med
Almost half of terminal cancer patient hospitalizations deemed avoidable
Nearly half of all intensive care unit hospitalizations among terminal oncology patients in a retrospective case review were identified as potentially avoidable.
The findings suggest a need for strategies to prospectively identify patients at risk for ICU admission and to formulate interventions to improve end-of-life care, wrote Bobby Daly, MD, and colleagues at the University of Chicago. The report was published in the Journal of Oncology Practice.
Of 72 terminal oncology patients who received care in a 600-bed academic medical center’s ambulatory oncology practice and died in an ICU between July 1, 2012, and June 30, 2013, within a week of transfer, 72% were men, 71% had solid tumor malignancies, and 51% had poor performance status (score of 2 or greater). The majority had multiple encounters with the health care system, but only 25% had a documented advance directive, the investigators found.
During a median ICU length of stay of 4 days, 82% of patients had a central line, 81% were intubated, 44% received a feeding tube, 39% received cardiopulmonary resuscitation, 22% began hemodialysis, and 8% received chemotherapy, while 6% had an inpatient palliative care consult, the researchers noted.
Notably, 47% of the ICU hospitalizations were determined to be potentially avoidable by at least two of three reviewers – an oncologist, an intensivist, and a hospitalist – and agreement between the reviewers was fair (kappa statistic, 0.24). Factors independently associated with avoidable hospitalizations on multivariable analysis were worse performance status prior to admission (median score, 2 vs. 1), worse Charlson comorbidity score (median, 8.5 vs. 7.0), number of hospitalizations in the previous 12 months (median, 2 vs. 1), and fewer days since the last outpatient oncology clinic visit (median 21 vs. 41 days). Having chemotherapy as the most recent treatment and cancer symptoms as the reason for hospitalization were also associated with potentially avoidable hospitalization (J Oncol Pract. 2016 Sep. doi: 10.1200/jop.2016.012823).
The findings are important because part of the reason for the increasing cost of cancer care in the United States, which is projected to increase by 27% over 2010 costs to $158 billion by 2020, is the increasingly aggressive care provided at the end of life, the investigators noted.
“Critically ill patients with cancer constitute a large percentage of ICU admissions, 25% of Medicare cancer beneficiaries receive ICU care in the last month of life, and 8% of patients with cancer die there,” they wrote.
Further, high-intensity end-of-life care has been shown in prior studies to improve neither survival nor quality of life for cancer patients.
In fact, the National Quality Forum “endorses ICU admissions in the last 30 days of life as a marker of poor-quality cancer care,” and other groups consider the proportion of patients with advanced cancer dying in the ICU as a quality-of-care metric, they said.
The current study was designed to explore the characteristics of oncology patients who expire in the ICU and the potential avoidability of their deaths there, and although the findings are limited by the single-center retrospective design and use of “subjective majority-driven medical record review,” they “serve to highlight terminal ICU hospitalization as an area of focus to improve the quality and value of cancer care,” the researchers wrote.
The findings also underscore the need for improved advance care planning, they added.
“Beyond the issues of cost and resource scarcity, these ICU deaths often create a traumatic experience for patients and families,” they wrote.
“Understanding these hospitalizations will contribute to the design of interventions aimed at avoiding unnecessary aggressive end-of-life care.”
Dr. Daly reported a leadership role with Quadrant Holdings and financial relationships with Quadrant Holdings, CVS Health, Johnson & Johnson, McKesson, and Walgreens Boots Alliance. Detailed disclosures for all authors are available with the full text of the article at jop.ascopubs.org.
Nearly half of all intensive care unit hospitalizations among terminal oncology patients in a retrospective case review were identified as potentially avoidable.
The findings suggest a need for strategies to prospectively identify patients at risk for ICU admission and to formulate interventions to improve end-of-life care, wrote Bobby Daly, MD, and colleagues at the University of Chicago. The report was published in the Journal of Oncology Practice.
Of 72 terminal oncology patients who received care in a 600-bed academic medical center’s ambulatory oncology practice and died in an ICU between July 1, 2012, and June 30, 2013, within a week of transfer, 72% were men, 71% had solid tumor malignancies, and 51% had poor performance status (score of 2 or greater). The majority had multiple encounters with the health care system, but only 25% had a documented advance directive, the investigators found.
During a median ICU length of stay of 4 days, 82% of patients had a central line, 81% were intubated, 44% received a feeding tube, 39% received cardiopulmonary resuscitation, 22% began hemodialysis, and 8% received chemotherapy, while 6% had an inpatient palliative care consult, the researchers noted.
Notably, 47% of the ICU hospitalizations were determined to be potentially avoidable by at least two of three reviewers – an oncologist, an intensivist, and a hospitalist – and agreement between the reviewers was fair (kappa statistic, 0.24). Factors independently associated with avoidable hospitalizations on multivariable analysis were worse performance status prior to admission (median score, 2 vs. 1), worse Charlson comorbidity score (median, 8.5 vs. 7.0), number of hospitalizations in the previous 12 months (median, 2 vs. 1), and fewer days since the last outpatient oncology clinic visit (median 21 vs. 41 days). Having chemotherapy as the most recent treatment and cancer symptoms as the reason for hospitalization were also associated with potentially avoidable hospitalization (J Oncol Pract. 2016 Sep. doi: 10.1200/jop.2016.012823).
The findings are important because part of the reason for the increasing cost of cancer care in the United States, which is projected to increase by 27% over 2010 costs to $158 billion by 2020, is the increasingly aggressive care provided at the end of life, the investigators noted.
“Critically ill patients with cancer constitute a large percentage of ICU admissions, 25% of Medicare cancer beneficiaries receive ICU care in the last month of life, and 8% of patients with cancer die there,” they wrote.
Further, high-intensity end-of-life care has been shown in prior studies to improve neither survival nor quality of life for cancer patients.
In fact, the National Quality Forum “endorses ICU admissions in the last 30 days of life as a marker of poor-quality cancer care,” and other groups consider the proportion of patients with advanced cancer dying in the ICU as a quality-of-care metric, they said.
The current study was designed to explore the characteristics of oncology patients who expire in the ICU and the potential avoidability of their deaths there, and although the findings are limited by the single-center retrospective design and use of “subjective majority-driven medical record review,” they “serve to highlight terminal ICU hospitalization as an area of focus to improve the quality and value of cancer care,” the researchers wrote.
The findings also underscore the need for improved advance care planning, they added.
“Beyond the issues of cost and resource scarcity, these ICU deaths often create a traumatic experience for patients and families,” they wrote.
“Understanding these hospitalizations will contribute to the design of interventions aimed at avoiding unnecessary aggressive end-of-life care.”
Dr. Daly reported a leadership role with Quadrant Holdings and financial relationships with Quadrant Holdings, CVS Health, Johnson & Johnson, McKesson, and Walgreens Boots Alliance. Detailed disclosures for all authors are available with the full text of the article at jop.ascopubs.org.
Nearly half of all intensive care unit hospitalizations among terminal oncology patients in a retrospective case review were identified as potentially avoidable.
The findings suggest a need for strategies to prospectively identify patients at risk for ICU admission and to formulate interventions to improve end-of-life care, wrote Bobby Daly, MD, and colleagues at the University of Chicago. The report was published in the Journal of Oncology Practice.
Of 72 terminal oncology patients who received care in a 600-bed academic medical center’s ambulatory oncology practice and died in an ICU between July 1, 2012, and June 30, 2013, within a week of transfer, 72% were men, 71% had solid tumor malignancies, and 51% had poor performance status (score of 2 or greater). The majority had multiple encounters with the health care system, but only 25% had a documented advance directive, the investigators found.
During a median ICU length of stay of 4 days, 82% of patients had a central line, 81% were intubated, 44% received a feeding tube, 39% received cardiopulmonary resuscitation, 22% began hemodialysis, and 8% received chemotherapy, while 6% had an inpatient palliative care consult, the researchers noted.
Notably, 47% of the ICU hospitalizations were determined to be potentially avoidable by at least two of three reviewers – an oncologist, an intensivist, and a hospitalist – and agreement between the reviewers was fair (kappa statistic, 0.24). Factors independently associated with avoidable hospitalizations on multivariable analysis were worse performance status prior to admission (median score, 2 vs. 1), worse Charlson comorbidity score (median, 8.5 vs. 7.0), number of hospitalizations in the previous 12 months (median, 2 vs. 1), and fewer days since the last outpatient oncology clinic visit (median 21 vs. 41 days). Having chemotherapy as the most recent treatment and cancer symptoms as the reason for hospitalization were also associated with potentially avoidable hospitalization (J Oncol Pract. 2016 Sep. doi: 10.1200/jop.2016.012823).
The findings are important because part of the reason for the increasing cost of cancer care in the United States, which is projected to increase by 27% over 2010 costs to $158 billion by 2020, is the increasingly aggressive care provided at the end of life, the investigators noted.
“Critically ill patients with cancer constitute a large percentage of ICU admissions, 25% of Medicare cancer beneficiaries receive ICU care in the last month of life, and 8% of patients with cancer die there,” they wrote.
Further, high-intensity end-of-life care has been shown in prior studies to improve neither survival nor quality of life for cancer patients.
In fact, the National Quality Forum “endorses ICU admissions in the last 30 days of life as a marker of poor-quality cancer care,” and other groups consider the proportion of patients with advanced cancer dying in the ICU as a quality-of-care metric, they said.
The current study was designed to explore the characteristics of oncology patients who expire in the ICU and the potential avoidability of their deaths there, and although the findings are limited by the single-center retrospective design and use of “subjective majority-driven medical record review,” they “serve to highlight terminal ICU hospitalization as an area of focus to improve the quality and value of cancer care,” the researchers wrote.
The findings also underscore the need for improved advance care planning, they added.
“Beyond the issues of cost and resource scarcity, these ICU deaths often create a traumatic experience for patients and families,” they wrote.
“Understanding these hospitalizations will contribute to the design of interventions aimed at avoiding unnecessary aggressive end-of-life care.”
Dr. Daly reported a leadership role with Quadrant Holdings and financial relationships with Quadrant Holdings, CVS Health, Johnson & Johnson, McKesson, and Walgreens Boots Alliance. Detailed disclosures for all authors are available with the full text of the article at jop.ascopubs.org.
Key clinical point:
Major finding: Almost half (47%) of the ICU hospitalizations were determined by a majority of reviewers to be potentially avoidable.
Data source: A retrospective review of 72 cases.
Disclosures: Dr. Daly reported a leadership role with Quadrant Holdings and financial relationships with Quadrant Holdings, CVS Health, Johnson & Johnson, McKesson, and Walgreens Boots Alliance. Detailed disclosures for all authors are available with the full text of the article at jop.ascopubs.org.
Conservative oxygen therapy in the ICU reduces mortality
A strategy of conservatively controlling oxygen delivery to patients in the intensive care unit results in lower mortality than the conventional, more liberal approach whereby patients are often kept in a hyperoxemic state, finds a randomized controlled trial.
The trial, known as Oxygen-ICU, enrolled more than 400 adult ICU patients from an Italian center. Initially planned to last 2 years, it was terminated early because of slow enrollment after an earthquake reduced ICU capacity, with the decision supported by positive results of an interim analysis.
Patients had an absolute nearly 9% lower risk of dying in the ICU with use of the conservative oxygen strategy as compared with the conventional one, according to data reported at the annual congress of the European Society of Intensive Care Medicine and simultaneously published (JAMA. 2016 Oct 5. doi: 10.1001/jama.2016.11993).
“To our knowledge, this is the first randomized clinical trial to evaluate the effect of a conservative oxygen therapy on mortality compared with a standard, more liberal approach in a medical-surgical population of adult critically ill patients,” write the investigators, who were led by Massimo Girardis, MD, of the Intensive Care Unit, Department of Anesthesiology and Intensive Care, University Hospital of Modena (Italy).
Among critically ill patients with an ICU length of stay of 72 hours or longer, a conservative protocol for oxygen therapy compared with conventional therapy resulted in a lower ICU mortality,” they conclude. “However, these preliminary findings were based on unplanned early termination of the trial, and a larger multicenter trial is needed to evaluate the potential benefit of such conservative oxygen therapy in critically ill patients.”
In the trial, consecutive patients were randomized evenly to receive conservative oxygen therapy (maintenance of PaO2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation [SpO2] between 94% and 98%) or conventional oxygen therapy (allowance of PaO2 values up to 150 mm Hg or SpO2 values between 97% and 100%) on an open-label basis.
The originally targeted enrollment was 660 patients, but the study was stopped early after only 480 patients had been enrolled.
Results of modified intent-to-treat analyses showed that daily time-weighted PaO2 averages during patients’ ICU stays were higher in the conventional group than in the conservative group (median PaO2, 102 vs. 87 mm Hg; P less than .001).
The rate of ICU mortality, the trial’s primary endpoint, was 11.6% with conservative therapy, about half of the 20.2% seen with conventional therapy (absolute mean difference, 0.086; P = .01).
The conservative group also had lower rates of shock (3.7% vs. 10.6%, P = .006), liver failure (1.9% vs. 6.4%, P = .02), and bacteremia (5.1% vs. 10.1%, P = .049). And they spent a day less on the ventilator (median mechanical ventilation–free hours, 72 vs. 48; P = .02).
Lengths of ICU stay and hospital stay did not differ between the two groups.
One of the study authors reports serving as the data monitoring chair for a phase II study sponsored by InflaRx, on the antibiotic advisory board for Bayer, and on sepsis advisory boards for Biotest and Merck. The study was supported by the National Fund for Scientific Research of the University of Modena and Reggio Emilia.
The reduction in mortality seen with conservative oxygen therapy in the Oxygen-ICU trial was “striking,” according to editorialist Dr. Niall D. Ferguson. However, “it is likely that to some extent, this trial has overestimated the true treatment effect of conservative oxygen therapy,” he cautions, given baseline imbalances between groups, early stopping based in part on an unplanned interim analysis, and the small number of deaths. The editorialist noted that the study was underpowered and criticized its use of a modified intent-to-treat analysis.
The trial’s findings contrast with those of a pilot study conducted by the ANZICS clinical trials group that did not find better outcomes with use of lower oxygen targets, according to Dr. Ferguson. However, in that trial, both arms had lower target and actual PaO2 levels. Thus, the optimal clinical approach remains uncertain.
“Until the results of further trials addressing this issue are available, there appears to be little downside in the careful titration and monitoring of supplemental oxygen in the ICU to achieve physiologically normal levels of PaO2 while avoiding potentially dangerous hyperoxia,” he concludes.
Dr. Ferguson disclosed that he has no relevant conflicts of interest.
Niall D. Ferguson, MD, MSc, is with the Interdepartmental Division of Critical Care Medicine and Departments of Medicine and Physiology, University of Toronto; the Institute of Health Policy, Management, & Evaluation, University of Toronto; the Division of Respirology, Department of Medicine, University Health Network and Mount Sinai Hospital; and the Toronto General Research Institute.
The reduction in mortality seen with conservative oxygen therapy in the Oxygen-ICU trial was “striking,” according to editorialist Dr. Niall D. Ferguson. However, “it is likely that to some extent, this trial has overestimated the true treatment effect of conservative oxygen therapy,” he cautions, given baseline imbalances between groups, early stopping based in part on an unplanned interim analysis, and the small number of deaths. The editorialist noted that the study was underpowered and criticized its use of a modified intent-to-treat analysis.
The trial’s findings contrast with those of a pilot study conducted by the ANZICS clinical trials group that did not find better outcomes with use of lower oxygen targets, according to Dr. Ferguson. However, in that trial, both arms had lower target and actual PaO2 levels. Thus, the optimal clinical approach remains uncertain.
“Until the results of further trials addressing this issue are available, there appears to be little downside in the careful titration and monitoring of supplemental oxygen in the ICU to achieve physiologically normal levels of PaO2 while avoiding potentially dangerous hyperoxia,” he concludes.
Dr. Ferguson disclosed that he has no relevant conflicts of interest.
Niall D. Ferguson, MD, MSc, is with the Interdepartmental Division of Critical Care Medicine and Departments of Medicine and Physiology, University of Toronto; the Institute of Health Policy, Management, & Evaluation, University of Toronto; the Division of Respirology, Department of Medicine, University Health Network and Mount Sinai Hospital; and the Toronto General Research Institute.
The reduction in mortality seen with conservative oxygen therapy in the Oxygen-ICU trial was “striking,” according to editorialist Dr. Niall D. Ferguson. However, “it is likely that to some extent, this trial has overestimated the true treatment effect of conservative oxygen therapy,” he cautions, given baseline imbalances between groups, early stopping based in part on an unplanned interim analysis, and the small number of deaths. The editorialist noted that the study was underpowered and criticized its use of a modified intent-to-treat analysis.
The trial’s findings contrast with those of a pilot study conducted by the ANZICS clinical trials group that did not find better outcomes with use of lower oxygen targets, according to Dr. Ferguson. However, in that trial, both arms had lower target and actual PaO2 levels. Thus, the optimal clinical approach remains uncertain.
“Until the results of further trials addressing this issue are available, there appears to be little downside in the careful titration and monitoring of supplemental oxygen in the ICU to achieve physiologically normal levels of PaO2 while avoiding potentially dangerous hyperoxia,” he concludes.
Dr. Ferguson disclosed that he has no relevant conflicts of interest.
Niall D. Ferguson, MD, MSc, is with the Interdepartmental Division of Critical Care Medicine and Departments of Medicine and Physiology, University of Toronto; the Institute of Health Policy, Management, & Evaluation, University of Toronto; the Division of Respirology, Department of Medicine, University Health Network and Mount Sinai Hospital; and the Toronto General Research Institute.
A strategy of conservatively controlling oxygen delivery to patients in the intensive care unit results in lower mortality than the conventional, more liberal approach whereby patients are often kept in a hyperoxemic state, finds a randomized controlled trial.
The trial, known as Oxygen-ICU, enrolled more than 400 adult ICU patients from an Italian center. Initially planned to last 2 years, it was terminated early because of slow enrollment after an earthquake reduced ICU capacity, with the decision supported by positive results of an interim analysis.
Patients had an absolute nearly 9% lower risk of dying in the ICU with use of the conservative oxygen strategy as compared with the conventional one, according to data reported at the annual congress of the European Society of Intensive Care Medicine and simultaneously published (JAMA. 2016 Oct 5. doi: 10.1001/jama.2016.11993).
“To our knowledge, this is the first randomized clinical trial to evaluate the effect of a conservative oxygen therapy on mortality compared with a standard, more liberal approach in a medical-surgical population of adult critically ill patients,” write the investigators, who were led by Massimo Girardis, MD, of the Intensive Care Unit, Department of Anesthesiology and Intensive Care, University Hospital of Modena (Italy).
Among critically ill patients with an ICU length of stay of 72 hours or longer, a conservative protocol for oxygen therapy compared with conventional therapy resulted in a lower ICU mortality,” they conclude. “However, these preliminary findings were based on unplanned early termination of the trial, and a larger multicenter trial is needed to evaluate the potential benefit of such conservative oxygen therapy in critically ill patients.”
In the trial, consecutive patients were randomized evenly to receive conservative oxygen therapy (maintenance of PaO2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation [SpO2] between 94% and 98%) or conventional oxygen therapy (allowance of PaO2 values up to 150 mm Hg or SpO2 values between 97% and 100%) on an open-label basis.
The originally targeted enrollment was 660 patients, but the study was stopped early after only 480 patients had been enrolled.
Results of modified intent-to-treat analyses showed that daily time-weighted PaO2 averages during patients’ ICU stays were higher in the conventional group than in the conservative group (median PaO2, 102 vs. 87 mm Hg; P less than .001).
The rate of ICU mortality, the trial’s primary endpoint, was 11.6% with conservative therapy, about half of the 20.2% seen with conventional therapy (absolute mean difference, 0.086; P = .01).
The conservative group also had lower rates of shock (3.7% vs. 10.6%, P = .006), liver failure (1.9% vs. 6.4%, P = .02), and bacteremia (5.1% vs. 10.1%, P = .049). And they spent a day less on the ventilator (median mechanical ventilation–free hours, 72 vs. 48; P = .02).
Lengths of ICU stay and hospital stay did not differ between the two groups.
One of the study authors reports serving as the data monitoring chair for a phase II study sponsored by InflaRx, on the antibiotic advisory board for Bayer, and on sepsis advisory boards for Biotest and Merck. The study was supported by the National Fund for Scientific Research of the University of Modena and Reggio Emilia.
A strategy of conservatively controlling oxygen delivery to patients in the intensive care unit results in lower mortality than the conventional, more liberal approach whereby patients are often kept in a hyperoxemic state, finds a randomized controlled trial.
The trial, known as Oxygen-ICU, enrolled more than 400 adult ICU patients from an Italian center. Initially planned to last 2 years, it was terminated early because of slow enrollment after an earthquake reduced ICU capacity, with the decision supported by positive results of an interim analysis.
Patients had an absolute nearly 9% lower risk of dying in the ICU with use of the conservative oxygen strategy as compared with the conventional one, according to data reported at the annual congress of the European Society of Intensive Care Medicine and simultaneously published (JAMA. 2016 Oct 5. doi: 10.1001/jama.2016.11993).
“To our knowledge, this is the first randomized clinical trial to evaluate the effect of a conservative oxygen therapy on mortality compared with a standard, more liberal approach in a medical-surgical population of adult critically ill patients,” write the investigators, who were led by Massimo Girardis, MD, of the Intensive Care Unit, Department of Anesthesiology and Intensive Care, University Hospital of Modena (Italy).
Among critically ill patients with an ICU length of stay of 72 hours or longer, a conservative protocol for oxygen therapy compared with conventional therapy resulted in a lower ICU mortality,” they conclude. “However, these preliminary findings were based on unplanned early termination of the trial, and a larger multicenter trial is needed to evaluate the potential benefit of such conservative oxygen therapy in critically ill patients.”
In the trial, consecutive patients were randomized evenly to receive conservative oxygen therapy (maintenance of PaO2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation [SpO2] between 94% and 98%) or conventional oxygen therapy (allowance of PaO2 values up to 150 mm Hg or SpO2 values between 97% and 100%) on an open-label basis.
The originally targeted enrollment was 660 patients, but the study was stopped early after only 480 patients had been enrolled.
Results of modified intent-to-treat analyses showed that daily time-weighted PaO2 averages during patients’ ICU stays were higher in the conventional group than in the conservative group (median PaO2, 102 vs. 87 mm Hg; P less than .001).
The rate of ICU mortality, the trial’s primary endpoint, was 11.6% with conservative therapy, about half of the 20.2% seen with conventional therapy (absolute mean difference, 0.086; P = .01).
The conservative group also had lower rates of shock (3.7% vs. 10.6%, P = .006), liver failure (1.9% vs. 6.4%, P = .02), and bacteremia (5.1% vs. 10.1%, P = .049). And they spent a day less on the ventilator (median mechanical ventilation–free hours, 72 vs. 48; P = .02).
Lengths of ICU stay and hospital stay did not differ between the two groups.
One of the study authors reports serving as the data monitoring chair for a phase II study sponsored by InflaRx, on the antibiotic advisory board for Bayer, and on sepsis advisory boards for Biotest and Merck. The study was supported by the National Fund for Scientific Research of the University of Modena and Reggio Emilia.
FROM ESICM CONGRESS 2016
Key clinical point:
Major finding: Relative to conventional therapy, conservative therapy was associated with a lower ICU mortality (absolute risk reduction, 0.086; P = .01).
Data source: A randomized controlled trial among 434 patients admitted to a medical-surgical ICU and expected to stay at least 72 hours (Oxygen-ICU trial).
Disclosures: One of the study authors reports serving as the data monitoring chair for a phase II study sponsored by InflaRx, on the antibiotic advisory board for Bayer, and on sepsis advisory boards for Biotest and Merck. The study was supported by the National Fund for Scientific Research of the University of Modena and Reggio Emilia. Dr. Ferguson disclosed that he has no relevant conflicts of interest.
Facing a medical board investigation
(This column is the third of a three-part series.)
Question: The state medical board is requesting the medical records of an angry patient who has filed a formal complaint alleging incompetent care. Your immediate impulse is to rush off a letter defending your treatment – and to include a sarcastic remark about ingratitude.
However, you decided not to respond, choosing to await the scheduled interview with the board investigator. To your surprise, he turned out to be warm and friendly, and his relative youth reminded you of your son. Letting your guard down, you spoke freely during the meeting and showed him the medical records. Later, you appeared at the formal board hearing without legal counsel, as the complainant had not suffered any injury while under your care. Under this scenario, which of the following statements is best?
A. You must never respond in writing to any board inquiry.
B. You should have called your insurance carrier immediately.
C. You trusted the investigator because what you told him could not be introduced as evidence.
D. You correctly assumed that, without injuries, there is no liability.
E. You did not insist on having an attorney, because this is not part of your due process rights.
Answer: B. Who gets into trouble with medical disciplinary boards? In a California study,1 the authors concluded that male physicians were nearly three times as likely to as women physicians, and those who were non–board certified twice as likely to as their board-certified counterparts. Obstetricians, gynecologists, family physicians, general practitioners, and psychiatrists were more likely than internists, whereas pediatricians and radiologists were the least likely. Age had a smaller influence (elevated risk with increasing age), and foreign medical graduates also had an increased risk.
It is true that many board complaints are dismissed and never investigated, but the number of state licensure actions in 2013 was almost four times greater than the number of malpractice payouts. Moreover, board actions against a doctor, unlike a malpractice lawsuit, are premised on substandard or unethical conduct, and do not require a showing of actual patient harm.
A recent news article bemoans the travails of a medical board encounter.2 According to a 2009 report, one of every eight physicians in California was being reported to the board each year, with a quarter of complaints leading to an investigation. In turn, a quarter of investigated complaints led to disciplinary proceedings against the physician.
A medical board investigation begins with a complaint lodged by a patient or some other party such as a pharmacist, nurse, or hospital peer review committee. Some states – e.g., California, Georgia, and Maryland – allow complaints to be anonymous, and many states now allow online submissions, whose ease may be expected to increase the number of filings. Oklahoma, for example, saw its board complaints rise by 40% in the 2 years after permitting this option.
Some complaints such as rudeness and disputes over fees may seem like a minor nuisance, but they can mushroom into new and more serious charges. The medical records may reveal other potential misconduct, such as delinquent record keeping or failure to obtain informed consent.
It is therefore prudent to treat all complaints seriously. A written response is necessary, but it must be cowritten with your attorney. Immediately contact your malpractice insurance carrier once an investigator approaches you, or upon notification by the medical board. Most malpractice policies include coverage for medical board investigations.
The simple rule is not to discuss with anyone – including (especially) the complainant – and await a call from the attorney assigned to you. Better yet, ask for an attorney whose skills you are aware of. Make sure he/she is experienced with board proceedings and not just malpractice litigation. There are legal technicalities that may be of importance, such as statutes of limitations barring board actions or the timely filing of an appeal. Everything should flow from here. The lawyer’s advice will most likely be: “Don’t speak to anyone, including your colleagues; don’t contact the patient or family; and don’t release any records without first consulting me.”
You should together draft a response letter. Whereas the attorney will be attentive to the legal ramifications, only you as the doctor can provide the clinical knowledge, context, and empathy. In formulating any written response where patient care is at issue, heed the following principles:
1. Be honest. Truth always surfaces in due course. Candor and trustworthiness are virtues expected of all doctors.
2. Be accurate. Review carefully all relevant medical records. Pay compulsive attention to factual accuracy.
3. Be focused. Do not ramble on and on regarding unrelated or tangential issues. Focus on what the complaint is about. No one is interested in your views regarding your philosophy of medical practice or the health care system – they do not belong in a complaint response letter.
4. Be humble. Arrogance at this stage may prove disastrous. Adopt a contrite and humble tone. Blame no one, especially the patient.
5. Be a patient advocate. Show that patient well-being is always your first and last concern.
In the preliminary stages, a board investigator may call the doctor, typically taking a friendly and casual approach, and this may lull the physician into saying more than is necessary or releasing the medical records. The shared information can come back to haunt the doctor when it is disclosed in a subsequent hearing.
In some situations, the board may offer an informal settlement conference to resolve the issue and obtain a “consent agreement” from the doctor. Depending on the facts – and the proposed settlement terms – your attorney may instead advise proceeding to a formal hearing to present exculpatory evidence and to confront the complainant.
Physicians are guaranteed the right of due process during an investigation. Timely notice, the right to a hearing, to confront the evidence, and to have legal representation are the basic due process rights. And boards must treat the physician fairly and reasonably.
However, where public harm is an imminent risk, boards have the power to immediately institute a temporary suspension of the doctor’s right to practice. Examples warranting such summary suspensions may include sexual misconduct, inappropriate opioid prescriptions, egregious negligent conduct, or impairment from alcohol or drug abuse.
Boards face a dilemma over these cases, because they need to balance depriving a doctor of due process rights, albeit temporarily, against allowing a bad doctor to pose a clear and present threat to the public. In Texas, 32 summary suspensions took place in 2011, a figure that fell to 13 in 2014.
The aggrieved physician typically has the right to appeal an adverse board decision to the courts, although “courts have no inherent appellate jurisdiction over official acts of administrative agencies except where the legislature has made some statutory provision for judicial review.”3
For example, under California’s Code of Civil Procedure section 1094.5, one has the right to have a Superior Court judge review the board’s decision to determine if there has been an abuse of discretion.
Despite the fact that board administrative proceedings are quasi criminal in nature, most states require only a “preponderance of evidence” to find the doctor guilty. This is the evidentiary standard used in civil cases where only monetary damages are at stake, yet it is used in determining whether a doctor would lose the liberty to practice his or her profession.
However, some jurisdictions – such as California, Florida, and Illinois – call for a higher threshold of guilt, requiring proof with “clear and convincing evidence.”
Finally, in the United Kingdom and countries such as Singapore, a guilty decision requires even more evidence – i.e., proof “beyond reasonable doubt” – which is the threshold required in criminal prosecutions.
References
1. Arch Intern Med. 2004 Mar 22;164(6):653-8.
2. Leigh Page. The Black Cloud of a Medical Board Investigation. Medscape, Dec 23, 2015.
3. Crane v. Cont’l Tel. Co. of Cal., 775 P.2d 705 (Nev. 1989).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
(This column is the third of a three-part series.)
Question: The state medical board is requesting the medical records of an angry patient who has filed a formal complaint alleging incompetent care. Your immediate impulse is to rush off a letter defending your treatment – and to include a sarcastic remark about ingratitude.
However, you decided not to respond, choosing to await the scheduled interview with the board investigator. To your surprise, he turned out to be warm and friendly, and his relative youth reminded you of your son. Letting your guard down, you spoke freely during the meeting and showed him the medical records. Later, you appeared at the formal board hearing without legal counsel, as the complainant had not suffered any injury while under your care. Under this scenario, which of the following statements is best?
A. You must never respond in writing to any board inquiry.
B. You should have called your insurance carrier immediately.
C. You trusted the investigator because what you told him could not be introduced as evidence.
D. You correctly assumed that, without injuries, there is no liability.
E. You did not insist on having an attorney, because this is not part of your due process rights.
Answer: B. Who gets into trouble with medical disciplinary boards? In a California study,1 the authors concluded that male physicians were nearly three times as likely to as women physicians, and those who were non–board certified twice as likely to as their board-certified counterparts. Obstetricians, gynecologists, family physicians, general practitioners, and psychiatrists were more likely than internists, whereas pediatricians and radiologists were the least likely. Age had a smaller influence (elevated risk with increasing age), and foreign medical graduates also had an increased risk.
It is true that many board complaints are dismissed and never investigated, but the number of state licensure actions in 2013 was almost four times greater than the number of malpractice payouts. Moreover, board actions against a doctor, unlike a malpractice lawsuit, are premised on substandard or unethical conduct, and do not require a showing of actual patient harm.
A recent news article bemoans the travails of a medical board encounter.2 According to a 2009 report, one of every eight physicians in California was being reported to the board each year, with a quarter of complaints leading to an investigation. In turn, a quarter of investigated complaints led to disciplinary proceedings against the physician.
A medical board investigation begins with a complaint lodged by a patient or some other party such as a pharmacist, nurse, or hospital peer review committee. Some states – e.g., California, Georgia, and Maryland – allow complaints to be anonymous, and many states now allow online submissions, whose ease may be expected to increase the number of filings. Oklahoma, for example, saw its board complaints rise by 40% in the 2 years after permitting this option.
Some complaints such as rudeness and disputes over fees may seem like a minor nuisance, but they can mushroom into new and more serious charges. The medical records may reveal other potential misconduct, such as delinquent record keeping or failure to obtain informed consent.
It is therefore prudent to treat all complaints seriously. A written response is necessary, but it must be cowritten with your attorney. Immediately contact your malpractice insurance carrier once an investigator approaches you, or upon notification by the medical board. Most malpractice policies include coverage for medical board investigations.
The simple rule is not to discuss with anyone – including (especially) the complainant – and await a call from the attorney assigned to you. Better yet, ask for an attorney whose skills you are aware of. Make sure he/she is experienced with board proceedings and not just malpractice litigation. There are legal technicalities that may be of importance, such as statutes of limitations barring board actions or the timely filing of an appeal. Everything should flow from here. The lawyer’s advice will most likely be: “Don’t speak to anyone, including your colleagues; don’t contact the patient or family; and don’t release any records without first consulting me.”
You should together draft a response letter. Whereas the attorney will be attentive to the legal ramifications, only you as the doctor can provide the clinical knowledge, context, and empathy. In formulating any written response where patient care is at issue, heed the following principles:
1. Be honest. Truth always surfaces in due course. Candor and trustworthiness are virtues expected of all doctors.
2. Be accurate. Review carefully all relevant medical records. Pay compulsive attention to factual accuracy.
3. Be focused. Do not ramble on and on regarding unrelated or tangential issues. Focus on what the complaint is about. No one is interested in your views regarding your philosophy of medical practice or the health care system – they do not belong in a complaint response letter.
4. Be humble. Arrogance at this stage may prove disastrous. Adopt a contrite and humble tone. Blame no one, especially the patient.
5. Be a patient advocate. Show that patient well-being is always your first and last concern.
In the preliminary stages, a board investigator may call the doctor, typically taking a friendly and casual approach, and this may lull the physician into saying more than is necessary or releasing the medical records. The shared information can come back to haunt the doctor when it is disclosed in a subsequent hearing.
In some situations, the board may offer an informal settlement conference to resolve the issue and obtain a “consent agreement” from the doctor. Depending on the facts – and the proposed settlement terms – your attorney may instead advise proceeding to a formal hearing to present exculpatory evidence and to confront the complainant.
Physicians are guaranteed the right of due process during an investigation. Timely notice, the right to a hearing, to confront the evidence, and to have legal representation are the basic due process rights. And boards must treat the physician fairly and reasonably.
However, where public harm is an imminent risk, boards have the power to immediately institute a temporary suspension of the doctor’s right to practice. Examples warranting such summary suspensions may include sexual misconduct, inappropriate opioid prescriptions, egregious negligent conduct, or impairment from alcohol or drug abuse.
Boards face a dilemma over these cases, because they need to balance depriving a doctor of due process rights, albeit temporarily, against allowing a bad doctor to pose a clear and present threat to the public. In Texas, 32 summary suspensions took place in 2011, a figure that fell to 13 in 2014.
The aggrieved physician typically has the right to appeal an adverse board decision to the courts, although “courts have no inherent appellate jurisdiction over official acts of administrative agencies except where the legislature has made some statutory provision for judicial review.”3
For example, under California’s Code of Civil Procedure section 1094.5, one has the right to have a Superior Court judge review the board’s decision to determine if there has been an abuse of discretion.
Despite the fact that board administrative proceedings are quasi criminal in nature, most states require only a “preponderance of evidence” to find the doctor guilty. This is the evidentiary standard used in civil cases where only monetary damages are at stake, yet it is used in determining whether a doctor would lose the liberty to practice his or her profession.
However, some jurisdictions – such as California, Florida, and Illinois – call for a higher threshold of guilt, requiring proof with “clear and convincing evidence.”
Finally, in the United Kingdom and countries such as Singapore, a guilty decision requires even more evidence – i.e., proof “beyond reasonable doubt” – which is the threshold required in criminal prosecutions.
References
1. Arch Intern Med. 2004 Mar 22;164(6):653-8.
2. Leigh Page. The Black Cloud of a Medical Board Investigation. Medscape, Dec 23, 2015.
3. Crane v. Cont’l Tel. Co. of Cal., 775 P.2d 705 (Nev. 1989).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
(This column is the third of a three-part series.)
Question: The state medical board is requesting the medical records of an angry patient who has filed a formal complaint alleging incompetent care. Your immediate impulse is to rush off a letter defending your treatment – and to include a sarcastic remark about ingratitude.
However, you decided not to respond, choosing to await the scheduled interview with the board investigator. To your surprise, he turned out to be warm and friendly, and his relative youth reminded you of your son. Letting your guard down, you spoke freely during the meeting and showed him the medical records. Later, you appeared at the formal board hearing without legal counsel, as the complainant had not suffered any injury while under your care. Under this scenario, which of the following statements is best?
A. You must never respond in writing to any board inquiry.
B. You should have called your insurance carrier immediately.
C. You trusted the investigator because what you told him could not be introduced as evidence.
D. You correctly assumed that, without injuries, there is no liability.
E. You did not insist on having an attorney, because this is not part of your due process rights.
Answer: B. Who gets into trouble with medical disciplinary boards? In a California study,1 the authors concluded that male physicians were nearly three times as likely to as women physicians, and those who were non–board certified twice as likely to as their board-certified counterparts. Obstetricians, gynecologists, family physicians, general practitioners, and psychiatrists were more likely than internists, whereas pediatricians and radiologists were the least likely. Age had a smaller influence (elevated risk with increasing age), and foreign medical graduates also had an increased risk.
It is true that many board complaints are dismissed and never investigated, but the number of state licensure actions in 2013 was almost four times greater than the number of malpractice payouts. Moreover, board actions against a doctor, unlike a malpractice lawsuit, are premised on substandard or unethical conduct, and do not require a showing of actual patient harm.
A recent news article bemoans the travails of a medical board encounter.2 According to a 2009 report, one of every eight physicians in California was being reported to the board each year, with a quarter of complaints leading to an investigation. In turn, a quarter of investigated complaints led to disciplinary proceedings against the physician.
A medical board investigation begins with a complaint lodged by a patient or some other party such as a pharmacist, nurse, or hospital peer review committee. Some states – e.g., California, Georgia, and Maryland – allow complaints to be anonymous, and many states now allow online submissions, whose ease may be expected to increase the number of filings. Oklahoma, for example, saw its board complaints rise by 40% in the 2 years after permitting this option.
Some complaints such as rudeness and disputes over fees may seem like a minor nuisance, but they can mushroom into new and more serious charges. The medical records may reveal other potential misconduct, such as delinquent record keeping or failure to obtain informed consent.
It is therefore prudent to treat all complaints seriously. A written response is necessary, but it must be cowritten with your attorney. Immediately contact your malpractice insurance carrier once an investigator approaches you, or upon notification by the medical board. Most malpractice policies include coverage for medical board investigations.
The simple rule is not to discuss with anyone – including (especially) the complainant – and await a call from the attorney assigned to you. Better yet, ask for an attorney whose skills you are aware of. Make sure he/she is experienced with board proceedings and not just malpractice litigation. There are legal technicalities that may be of importance, such as statutes of limitations barring board actions or the timely filing of an appeal. Everything should flow from here. The lawyer’s advice will most likely be: “Don’t speak to anyone, including your colleagues; don’t contact the patient or family; and don’t release any records without first consulting me.”
You should together draft a response letter. Whereas the attorney will be attentive to the legal ramifications, only you as the doctor can provide the clinical knowledge, context, and empathy. In formulating any written response where patient care is at issue, heed the following principles:
1. Be honest. Truth always surfaces in due course. Candor and trustworthiness are virtues expected of all doctors.
2. Be accurate. Review carefully all relevant medical records. Pay compulsive attention to factual accuracy.
3. Be focused. Do not ramble on and on regarding unrelated or tangential issues. Focus on what the complaint is about. No one is interested in your views regarding your philosophy of medical practice or the health care system – they do not belong in a complaint response letter.
4. Be humble. Arrogance at this stage may prove disastrous. Adopt a contrite and humble tone. Blame no one, especially the patient.
5. Be a patient advocate. Show that patient well-being is always your first and last concern.
In the preliminary stages, a board investigator may call the doctor, typically taking a friendly and casual approach, and this may lull the physician into saying more than is necessary or releasing the medical records. The shared information can come back to haunt the doctor when it is disclosed in a subsequent hearing.
In some situations, the board may offer an informal settlement conference to resolve the issue and obtain a “consent agreement” from the doctor. Depending on the facts – and the proposed settlement terms – your attorney may instead advise proceeding to a formal hearing to present exculpatory evidence and to confront the complainant.
Physicians are guaranteed the right of due process during an investigation. Timely notice, the right to a hearing, to confront the evidence, and to have legal representation are the basic due process rights. And boards must treat the physician fairly and reasonably.
However, where public harm is an imminent risk, boards have the power to immediately institute a temporary suspension of the doctor’s right to practice. Examples warranting such summary suspensions may include sexual misconduct, inappropriate opioid prescriptions, egregious negligent conduct, or impairment from alcohol or drug abuse.
Boards face a dilemma over these cases, because they need to balance depriving a doctor of due process rights, albeit temporarily, against allowing a bad doctor to pose a clear and present threat to the public. In Texas, 32 summary suspensions took place in 2011, a figure that fell to 13 in 2014.
The aggrieved physician typically has the right to appeal an adverse board decision to the courts, although “courts have no inherent appellate jurisdiction over official acts of administrative agencies except where the legislature has made some statutory provision for judicial review.”3
For example, under California’s Code of Civil Procedure section 1094.5, one has the right to have a Superior Court judge review the board’s decision to determine if there has been an abuse of discretion.
Despite the fact that board administrative proceedings are quasi criminal in nature, most states require only a “preponderance of evidence” to find the doctor guilty. This is the evidentiary standard used in civil cases where only monetary damages are at stake, yet it is used in determining whether a doctor would lose the liberty to practice his or her profession.
However, some jurisdictions – such as California, Florida, and Illinois – call for a higher threshold of guilt, requiring proof with “clear and convincing evidence.”
Finally, in the United Kingdom and countries such as Singapore, a guilty decision requires even more evidence – i.e., proof “beyond reasonable doubt” – which is the threshold required in criminal prosecutions.
References
1. Arch Intern Med. 2004 Mar 22;164(6):653-8.
2. Leigh Page. The Black Cloud of a Medical Board Investigation. Medscape, Dec 23, 2015.
3. Crane v. Cont’l Tel. Co. of Cal., 775 P.2d 705 (Nev. 1989).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
Novel device provides real-time glucose monitoring of critically ill
WAIKOLOA, HAWAII – Use of an automated bedside blood monitoring platform was safe and effective in measuring glucose in critically ill patients, results from a pivotal, prospective multicenter trial demonstrated.
“The hypermetabolic stress response to injury is a well-known entity following injury,” Grant V. Bochicchio, MD, FACS, said at the annual meeting of the American Association for the Surgery of Trauma. “Hyperglycemia has been shown to be intimately associated with this response. Numerous studies have reported that hyperglycemia has been associated with increased infection and worse outcome in critically injured trauma patients.” In addition, several studies have demonstrated that the glucose meters used for trauma patients are inaccurate, whether in relation to anemia or other factors, said Dr. Bochicchio, chief of acute and critical care surgery at Washington University, St. Louis.
The system includes the device itself as well as a single-use, disposable cartridge, which is the only point of contact with the patient’s blood. A proprietary zero-depth space connector seamlessly attaches a disposable cartridge to the patient’s IV line, to ensure that blood flows smoothly without the need for heparin. “The OptiScanner automatically draws blood and the spectrometer measures blood glucose directly from the plasma sample without the need of calibration,” Dr. Bochicchio said. “Plasma glucose results are then displayed on the screen along with a trending graph of the glucose values. If the glucose values move outside of the desired range, the OptiScanner alerts the clinician by displaying the glucose value against a red background. We’re actually measuring [blood glucose] at the time of the patient in the ICU without having to send it to a lab, without having to wait 4 hours for a turnaround. This is where we have to go with ICU medicine.”
The purpose of the current trial was to evaluate the safety and accuracy of the OptiScanner in patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring. To be eligible they had to have a central line in place and could not have hematocrit level of less than 15% or greater than 60% on enrollment, and they had to be able to connect to the proximal port of the central venous catheter. Enrollment was defined as time of connection to the OptiScanner. Patients could remain connected for up to 72 hours. Blood draws were performed every 15 minutes, and a comparative sample was drawn within a 2-minute window at a minimum of 1-hour interval. The paired blood samples were then spun down for plasma within 15 minutes by the study team and analyzed twice by the Yellow Springs Instrument STAT Plus Glucose and Lactate Analyzer, which is the gold standard for measuring blood glucose levels remotely.
The primary endpoint was a mean absolute relative deviation (MARD) of 10% or less, while the secondary endpoint was a population coefficient of variance (PCV) of 13% or less. The mean age of the 200 patients was 62 years, 69% were male, 83% were white, and their mean Apache II score was 15.1. An analysis of 3,735 paired readings revealed that the mean MARD was 7.6%, “which is better than what we set our objective for,” Dr. Bochicchio said. The mean PCV was 9.8%, “which was the ideal,” he said. “So we achieved our primary and secondary objectives.” More than half of patients (52%) exhibited at least one form of dysglycemia, while 25% of patients exhibited at least one episode of hypoglycemia, severe hyperglycemia, or glycemic variability.
The invited discussant, Dennis Y. Kim, MD, FACS, noted that glucose control remains a key tenet of modern-day critical care. “It’s difficult to ignore the numerous technical and logistical challenges involved in obtaining a rapid and accurate glucose measurement upon which protocolized management decisions can be instituted,” said Dr. Kim, a surgeon at Harbor-UCLA Medical Center, Los Angeles. “Reliability of point of care devices, the ever-increasing work demands on our ICU nurses, and lack of sufficient data points to permit analysis of trends are but a few of the issues surrounding glycemic control. Dr. Bochicchio and his colleagues are to be congratulated on the present study, which proposes a potential solution to the aforementioned problems in managing hyperglycemia in the ICU.”
The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.
WAIKOLOA, HAWAII – Use of an automated bedside blood monitoring platform was safe and effective in measuring glucose in critically ill patients, results from a pivotal, prospective multicenter trial demonstrated.
“The hypermetabolic stress response to injury is a well-known entity following injury,” Grant V. Bochicchio, MD, FACS, said at the annual meeting of the American Association for the Surgery of Trauma. “Hyperglycemia has been shown to be intimately associated with this response. Numerous studies have reported that hyperglycemia has been associated with increased infection and worse outcome in critically injured trauma patients.” In addition, several studies have demonstrated that the glucose meters used for trauma patients are inaccurate, whether in relation to anemia or other factors, said Dr. Bochicchio, chief of acute and critical care surgery at Washington University, St. Louis.
The system includes the device itself as well as a single-use, disposable cartridge, which is the only point of contact with the patient’s blood. A proprietary zero-depth space connector seamlessly attaches a disposable cartridge to the patient’s IV line, to ensure that blood flows smoothly without the need for heparin. “The OptiScanner automatically draws blood and the spectrometer measures blood glucose directly from the plasma sample without the need of calibration,” Dr. Bochicchio said. “Plasma glucose results are then displayed on the screen along with a trending graph of the glucose values. If the glucose values move outside of the desired range, the OptiScanner alerts the clinician by displaying the glucose value against a red background. We’re actually measuring [blood glucose] at the time of the patient in the ICU without having to send it to a lab, without having to wait 4 hours for a turnaround. This is where we have to go with ICU medicine.”
The purpose of the current trial was to evaluate the safety and accuracy of the OptiScanner in patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring. To be eligible they had to have a central line in place and could not have hematocrit level of less than 15% or greater than 60% on enrollment, and they had to be able to connect to the proximal port of the central venous catheter. Enrollment was defined as time of connection to the OptiScanner. Patients could remain connected for up to 72 hours. Blood draws were performed every 15 minutes, and a comparative sample was drawn within a 2-minute window at a minimum of 1-hour interval. The paired blood samples were then spun down for plasma within 15 minutes by the study team and analyzed twice by the Yellow Springs Instrument STAT Plus Glucose and Lactate Analyzer, which is the gold standard for measuring blood glucose levels remotely.
The primary endpoint was a mean absolute relative deviation (MARD) of 10% or less, while the secondary endpoint was a population coefficient of variance (PCV) of 13% or less. The mean age of the 200 patients was 62 years, 69% were male, 83% were white, and their mean Apache II score was 15.1. An analysis of 3,735 paired readings revealed that the mean MARD was 7.6%, “which is better than what we set our objective for,” Dr. Bochicchio said. The mean PCV was 9.8%, “which was the ideal,” he said. “So we achieved our primary and secondary objectives.” More than half of patients (52%) exhibited at least one form of dysglycemia, while 25% of patients exhibited at least one episode of hypoglycemia, severe hyperglycemia, or glycemic variability.
The invited discussant, Dennis Y. Kim, MD, FACS, noted that glucose control remains a key tenet of modern-day critical care. “It’s difficult to ignore the numerous technical and logistical challenges involved in obtaining a rapid and accurate glucose measurement upon which protocolized management decisions can be instituted,” said Dr. Kim, a surgeon at Harbor-UCLA Medical Center, Los Angeles. “Reliability of point of care devices, the ever-increasing work demands on our ICU nurses, and lack of sufficient data points to permit analysis of trends are but a few of the issues surrounding glycemic control. Dr. Bochicchio and his colleagues are to be congratulated on the present study, which proposes a potential solution to the aforementioned problems in managing hyperglycemia in the ICU.”
The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.
WAIKOLOA, HAWAII – Use of an automated bedside blood monitoring platform was safe and effective in measuring glucose in critically ill patients, results from a pivotal, prospective multicenter trial demonstrated.
“The hypermetabolic stress response to injury is a well-known entity following injury,” Grant V. Bochicchio, MD, FACS, said at the annual meeting of the American Association for the Surgery of Trauma. “Hyperglycemia has been shown to be intimately associated with this response. Numerous studies have reported that hyperglycemia has been associated with increased infection and worse outcome in critically injured trauma patients.” In addition, several studies have demonstrated that the glucose meters used for trauma patients are inaccurate, whether in relation to anemia or other factors, said Dr. Bochicchio, chief of acute and critical care surgery at Washington University, St. Louis.
The system includes the device itself as well as a single-use, disposable cartridge, which is the only point of contact with the patient’s blood. A proprietary zero-depth space connector seamlessly attaches a disposable cartridge to the patient’s IV line, to ensure that blood flows smoothly without the need for heparin. “The OptiScanner automatically draws blood and the spectrometer measures blood glucose directly from the plasma sample without the need of calibration,” Dr. Bochicchio said. “Plasma glucose results are then displayed on the screen along with a trending graph of the glucose values. If the glucose values move outside of the desired range, the OptiScanner alerts the clinician by displaying the glucose value against a red background. We’re actually measuring [blood glucose] at the time of the patient in the ICU without having to send it to a lab, without having to wait 4 hours for a turnaround. This is where we have to go with ICU medicine.”
The purpose of the current trial was to evaluate the safety and accuracy of the OptiScanner in patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring. To be eligible they had to have a central line in place and could not have hematocrit level of less than 15% or greater than 60% on enrollment, and they had to be able to connect to the proximal port of the central venous catheter. Enrollment was defined as time of connection to the OptiScanner. Patients could remain connected for up to 72 hours. Blood draws were performed every 15 minutes, and a comparative sample was drawn within a 2-minute window at a minimum of 1-hour interval. The paired blood samples were then spun down for plasma within 15 minutes by the study team and analyzed twice by the Yellow Springs Instrument STAT Plus Glucose and Lactate Analyzer, which is the gold standard for measuring blood glucose levels remotely.
The primary endpoint was a mean absolute relative deviation (MARD) of 10% or less, while the secondary endpoint was a population coefficient of variance (PCV) of 13% or less. The mean age of the 200 patients was 62 years, 69% were male, 83% were white, and their mean Apache II score was 15.1. An analysis of 3,735 paired readings revealed that the mean MARD was 7.6%, “which is better than what we set our objective for,” Dr. Bochicchio said. The mean PCV was 9.8%, “which was the ideal,” he said. “So we achieved our primary and secondary objectives.” More than half of patients (52%) exhibited at least one form of dysglycemia, while 25% of patients exhibited at least one episode of hypoglycemia, severe hyperglycemia, or glycemic variability.
The invited discussant, Dennis Y. Kim, MD, FACS, noted that glucose control remains a key tenet of modern-day critical care. “It’s difficult to ignore the numerous technical and logistical challenges involved in obtaining a rapid and accurate glucose measurement upon which protocolized management decisions can be instituted,” said Dr. Kim, a surgeon at Harbor-UCLA Medical Center, Los Angeles. “Reliability of point of care devices, the ever-increasing work demands on our ICU nurses, and lack of sufficient data points to permit analysis of trends are but a few of the issues surrounding glycemic control. Dr. Bochicchio and his colleagues are to be congratulated on the present study, which proposes a potential solution to the aforementioned problems in managing hyperglycemia in the ICU.”
The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.
AT THE AAST ANNUAL MEETING
Key clinical point:
Major finding: An analysis of 3,735 paired readings revealed that the mean absolute relative deviation (MARD) was 7.6%, which achieved the primary endpoint for accuracy.
Data source: A trial which set out to evaluate the safety and accuracy of the OptiScanner in 200 patients admitted to one of four ICUs who had an expected length of stay of 18 hours and required glucose monitoring.
Disclosures: The study was funded by OptiScan Biomedical. Dr. Bochicchio reported having no financial disclosures.
VIDEO: Harvoni shows safety, efficacy in adolescents for hepatitis C
MONTREAL – One of the antiviral drug combinations that has revolutionized treatment of hepatitis C virus in adults has for the first time been shown safe and effective against genotype 1 infections in adolescents aged 12-17 years old, paving the way to new regulatory labeling followed by easier and more reliable payer coverage for definitive hepatitis C treatment in this age group.
“I think having clear data on safety and efficacy and FDA [Food and Drug Administration] approval will greatly help getting insurance coverage,” for the tested combination of ledipasvir/sofosbuvir (Harvoni) Karen F. Murray, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition.
The results showed that in adolescents the ledipasvir/sofosbuvir formulation tested, at the same dosage approved for adults, was “very potent for genotype 1 hepatitis C, and was not only well tolerated but very easy” when given for 12 weeks, Dr. Murray said in an interview. The nearly perfect score for sustained virologic responses was “spectacular,” she added.
Ongoing studies that should finish soon are also looking at the safety and efficacy of ledipasvir/sofosbuvir in children aged 3-11 years old and in children and adolescents infected by other hepatitis C genotypes, specifically 4, 5, and 6. Taking on genotypes 2 and 3 will require additional treatment with ribavirin, she noted. Subsequent reports will also document patient outcomes 24 weeks from the start of treatment, after they’ve been off their completed regimen for 12 weeks. Gilead staffers have told Dr. Murray that they anticipate asking the FDA before the end of 2016 for approval to relabel the ledipasvir/sofosbuvir formulation they market to include adolescents, and possibly children too, depending on the outcome of studies still underway.
The result she reported came from 100 patients enrolled at 24 centers in the United States, Canada, and Europe. They averaged 15 years old, nearly two-thirds were girls, and 90% were white. One-fifth of the patients had been previously treated, and 81% were infected by genotype 1a hepatitis C with the remaining 19% infected with genotype 1b. Patients received the conventional, marketed formulation of ledipasvir/sofosbuvir, 90/400 mg, orally once daily.
Ninety-eight of the patients had no detectable hepatitis C virus in their blood at the end of 12 weeks of treatment. The other two patients were lost to follow-up and did not undergo virologic testing at the end of treatment and conservatively were tallied as nonresponders, she reported. A pharmacokinetic study done in a subgroup of patients showed plasma drug levels comparable with those seen in adults.
Although 71% of the patients reported having some adverse effect, no patient reported a serious or grade 3 or 4 adverse effect and no patient stopped treatment because of adverse effects. Nine patients had a grade 3 or 4 laboratory abnormality on treatment. The only lab abnormality to occur in more than one patient was a transient rise in amylase levels, which happened in three patients. The regimen’s overall performance in adolescents closely tracked what’s been seen in adults, Dr. Murray said.
“These data will lead to FDA approval” of the regimen for adolescents, she said confidently, and that will ease insurance coverage. “There will still be hoops to jump through, but with approval and once written into guidelines, insurers will be under pressure to reimburse for it,” she noted. “We find that, because of the cost, insurers resist or refuse to pay for these medications. The idea of treating only patients with advanced liver disease is morally inappropriate. These children must be treated before they develop significant or irreversible liver disease.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
MONTREAL – One of the antiviral drug combinations that has revolutionized treatment of hepatitis C virus in adults has for the first time been shown safe and effective against genotype 1 infections in adolescents aged 12-17 years old, paving the way to new regulatory labeling followed by easier and more reliable payer coverage for definitive hepatitis C treatment in this age group.
“I think having clear data on safety and efficacy and FDA [Food and Drug Administration] approval will greatly help getting insurance coverage,” for the tested combination of ledipasvir/sofosbuvir (Harvoni) Karen F. Murray, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition.
The results showed that in adolescents the ledipasvir/sofosbuvir formulation tested, at the same dosage approved for adults, was “very potent for genotype 1 hepatitis C, and was not only well tolerated but very easy” when given for 12 weeks, Dr. Murray said in an interview. The nearly perfect score for sustained virologic responses was “spectacular,” she added.
Ongoing studies that should finish soon are also looking at the safety and efficacy of ledipasvir/sofosbuvir in children aged 3-11 years old and in children and adolescents infected by other hepatitis C genotypes, specifically 4, 5, and 6. Taking on genotypes 2 and 3 will require additional treatment with ribavirin, she noted. Subsequent reports will also document patient outcomes 24 weeks from the start of treatment, after they’ve been off their completed regimen for 12 weeks. Gilead staffers have told Dr. Murray that they anticipate asking the FDA before the end of 2016 for approval to relabel the ledipasvir/sofosbuvir formulation they market to include adolescents, and possibly children too, depending on the outcome of studies still underway.
The result she reported came from 100 patients enrolled at 24 centers in the United States, Canada, and Europe. They averaged 15 years old, nearly two-thirds were girls, and 90% were white. One-fifth of the patients had been previously treated, and 81% were infected by genotype 1a hepatitis C with the remaining 19% infected with genotype 1b. Patients received the conventional, marketed formulation of ledipasvir/sofosbuvir, 90/400 mg, orally once daily.
Ninety-eight of the patients had no detectable hepatitis C virus in their blood at the end of 12 weeks of treatment. The other two patients were lost to follow-up and did not undergo virologic testing at the end of treatment and conservatively were tallied as nonresponders, she reported. A pharmacokinetic study done in a subgroup of patients showed plasma drug levels comparable with those seen in adults.
Although 71% of the patients reported having some adverse effect, no patient reported a serious or grade 3 or 4 adverse effect and no patient stopped treatment because of adverse effects. Nine patients had a grade 3 or 4 laboratory abnormality on treatment. The only lab abnormality to occur in more than one patient was a transient rise in amylase levels, which happened in three patients. The regimen’s overall performance in adolescents closely tracked what’s been seen in adults, Dr. Murray said.
“These data will lead to FDA approval” of the regimen for adolescents, she said confidently, and that will ease insurance coverage. “There will still be hoops to jump through, but with approval and once written into guidelines, insurers will be under pressure to reimburse for it,” she noted. “We find that, because of the cost, insurers resist or refuse to pay for these medications. The idea of treating only patients with advanced liver disease is morally inappropriate. These children must be treated before they develop significant or irreversible liver disease.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
MONTREAL – One of the antiviral drug combinations that has revolutionized treatment of hepatitis C virus in adults has for the first time been shown safe and effective against genotype 1 infections in adolescents aged 12-17 years old, paving the way to new regulatory labeling followed by easier and more reliable payer coverage for definitive hepatitis C treatment in this age group.
“I think having clear data on safety and efficacy and FDA [Food and Drug Administration] approval will greatly help getting insurance coverage,” for the tested combination of ledipasvir/sofosbuvir (Harvoni) Karen F. Murray, MD, said at the World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition.
The results showed that in adolescents the ledipasvir/sofosbuvir formulation tested, at the same dosage approved for adults, was “very potent for genotype 1 hepatitis C, and was not only well tolerated but very easy” when given for 12 weeks, Dr. Murray said in an interview. The nearly perfect score for sustained virologic responses was “spectacular,” she added.
Ongoing studies that should finish soon are also looking at the safety and efficacy of ledipasvir/sofosbuvir in children aged 3-11 years old and in children and adolescents infected by other hepatitis C genotypes, specifically 4, 5, and 6. Taking on genotypes 2 and 3 will require additional treatment with ribavirin, she noted. Subsequent reports will also document patient outcomes 24 weeks from the start of treatment, after they’ve been off their completed regimen for 12 weeks. Gilead staffers have told Dr. Murray that they anticipate asking the FDA before the end of 2016 for approval to relabel the ledipasvir/sofosbuvir formulation they market to include adolescents, and possibly children too, depending on the outcome of studies still underway.
The result she reported came from 100 patients enrolled at 24 centers in the United States, Canada, and Europe. They averaged 15 years old, nearly two-thirds were girls, and 90% were white. One-fifth of the patients had been previously treated, and 81% were infected by genotype 1a hepatitis C with the remaining 19% infected with genotype 1b. Patients received the conventional, marketed formulation of ledipasvir/sofosbuvir, 90/400 mg, orally once daily.
Ninety-eight of the patients had no detectable hepatitis C virus in their blood at the end of 12 weeks of treatment. The other two patients were lost to follow-up and did not undergo virologic testing at the end of treatment and conservatively were tallied as nonresponders, she reported. A pharmacokinetic study done in a subgroup of patients showed plasma drug levels comparable with those seen in adults.
Although 71% of the patients reported having some adverse effect, no patient reported a serious or grade 3 or 4 adverse effect and no patient stopped treatment because of adverse effects. Nine patients had a grade 3 or 4 laboratory abnormality on treatment. The only lab abnormality to occur in more than one patient was a transient rise in amylase levels, which happened in three patients. The regimen’s overall performance in adolescents closely tracked what’s been seen in adults, Dr. Murray said.
“These data will lead to FDA approval” of the regimen for adolescents, she said confidently, and that will ease insurance coverage. “There will still be hoops to jump through, but with approval and once written into guidelines, insurers will be under pressure to reimburse for it,” she noted. “We find that, because of the cost, insurers resist or refuse to pay for these medications. The idea of treating only patients with advanced liver disease is morally inappropriate. These children must be treated before they develop significant or irreversible liver disease.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT WCPGHAN 2016
Key clinical point:
Major finding: Hepatitis C virus was undetectable after 12 weeks of treatment in 98%; the remaining two patients were lost to follow-up.
Data source: A multicenter, open-label study with 100 patients, aged 12-17 years old, and chronically infected with hepatitis C genotype 1.
Disclosures: The study was sponsored by Gilead, the company that markets ledipasvir/sofosbuvir (Harvoni). Dr. Murray has received research support from Gilead and is a shareholder in Merck.
Brief screen helps identify patients with PTSD, depression
WAIKOLOA, HAWAII – A new nine-item tool known as the Injured Trauma Survivor Screen demonstrated strong sensitivity and specificity for predicting posttraumatic stress disorder and depression in trauma patients.
At the annual meeting of the American Association for the Surgery of Trauma, Terri deRoon-Cassini, PhD, said that the rates of PTSD among trauma patients range from 10% to 42%, depending on the type of injury sustained. “There is significant life impairment, including an increased risk for suicide and an increased risk for morbidity and mortality,” said Dr. deRoon-Cassini, a clinical psychologist and associate professor with the division of trauma and critical care at the Medical College of Wisconsin, Milwaukee.
The ACS Committee on Trauma currently recommends PTSD screening by trauma centers, including the 20-item PTSD Checklist and the nine-item PHD-9 for depression. However, these symptom-based screens were not validated in hospitalized trauma patients. “This becomes important, because according to the symptom trajectory of PTSD after trauma, about 22% of people experience chronic disease and about 16%-18% of people who have symptoms at baseline do not translate to symptoms by 6 months, so screening with a symptom-based measure isn’t always the best route,” she said.
In an effort to create a brief screening tool to identify those at risk for PTSD and depression following traumatic injury, Dr. deRoon-Cassini and her associates scoured existing medical literature on the topic to review risk factors and created an item pool of questions based on those risk factors. They came up with 47 items and statistically “funneled out the items to create the most parsimonious model predicting who goes on to develop PTSD and depression separately,” she explained. They then created the Injured Trauma Survivor Screen (ITSS), a nine-item list of yes/no questions that takes about 5 minutes to administer: five items for PTSD and five items for depression, with one item that overlaps. The five ITSS PTSD questions are:
• Did you think you were going to die? (risk factor being perceived life threat; odds ratio 6.32).
• Do you think this was done to you intentionally? (risk factor being intentionality; OR, 4.24).
• Have you felt more restless, tense, or jumpy than usual? (risk factor being assessment of arousal; OR, 5.31).
• Have you found yourself unable to stop worrying? (risk factor being worry/rumination; OR, 4.49).
• Do you find yourself thinking that the world is unsafe and that people are not to be trusted? (risk factor being negative alterations in cognition; OR, 5.52).
The five ITSS depression questions are:
• Have you ever taken medication for, or been given a mental health diagnosis? (risk factor being preexisting psychopathology; OR, 10.58).
• Has there ever been a time in your life you have been bothered by feeling down or hopeless or lost all interest in things you usually enjoyed for more than 2 weeks? (risk factor being premorbid depression; OR, 3.78).
• Did you think you were going to die? (risk factor being perceived life threat; OR, 9.69).
• Have you felt emotionally detached from your loved ones? (risk factor being negative alteration in mood; OR, 8.03).
• Do you find yourself crying and are unsure why? (risk factor being mood/depression; OR, 9.18).
The researchers administered the survey to 139 patients at two trauma centers. More than half (69%) were male, 48% were white, 40% were African American, and the remainder were from other ethnic backgrounds. The three most common mechanisms of injury were motor vehicle crashes (29%), motorcycle/all-terrain vehicle crashes (19%), and falls (13%). Dr. deRoon-Cassini reported that administration of the ITSS within 4 days of injury demonstrated a 75% sensitivity for identifying the risk for PTSD and depression, a 94% specificity for PTSD, and a 96% specificity for depression, with a cutoff score of 2 out of 5 for both subscales based on a receiver operating characteristic (ROC) curve analysis.
One month following administration of the ITSS, 20% of patients were diagnosed with depression and 29% were diagnosed with PTSD. Of those diagnosed with PTSD, 55% met criteria for concomitant depression “so we are seeing a high comorbidity between PTSD and depression, which is consistent with the medical literature,” she said.
“The ITSS represents a brief way that we can screen for PTSD and depression within a trauma system,” Dr. deRoon-Cassini said. “At our institution, social workers administer the tool. They have a flow sheet in our EMR system where they enter the responses. If someone screens positive, a best practice recommendation is put into the patient’s chart, which gets funneled to a trauma psychology consult. On the treatment side we try to intervene by triaging the severity of the current distress the person is experiencing, past comorbidities, and past trauma histories. From there we decide whether to do a brief intervention or more intensive evidence-based interventions for PTSD or depression together or separately.”
The study was funded by a grant from the Medical College of Wisconsin. Coauthors included Joshua Hunt, PhD, of the Medical College of Wisconsin, Milwaukee; Ann Marie Warren, PhD, of Baylor Medical Center, Dallas; and Karen Brasel, MD, FACS, of Oregon Health & Science University, Portland. Dr. deRoon-Cassini reported having no financial disclosures.
WAIKOLOA, HAWAII – A new nine-item tool known as the Injured Trauma Survivor Screen demonstrated strong sensitivity and specificity for predicting posttraumatic stress disorder and depression in trauma patients.
At the annual meeting of the American Association for the Surgery of Trauma, Terri deRoon-Cassini, PhD, said that the rates of PTSD among trauma patients range from 10% to 42%, depending on the type of injury sustained. “There is significant life impairment, including an increased risk for suicide and an increased risk for morbidity and mortality,” said Dr. deRoon-Cassini, a clinical psychologist and associate professor with the division of trauma and critical care at the Medical College of Wisconsin, Milwaukee.
The ACS Committee on Trauma currently recommends PTSD screening by trauma centers, including the 20-item PTSD Checklist and the nine-item PHD-9 for depression. However, these symptom-based screens were not validated in hospitalized trauma patients. “This becomes important, because according to the symptom trajectory of PTSD after trauma, about 22% of people experience chronic disease and about 16%-18% of people who have symptoms at baseline do not translate to symptoms by 6 months, so screening with a symptom-based measure isn’t always the best route,” she said.
In an effort to create a brief screening tool to identify those at risk for PTSD and depression following traumatic injury, Dr. deRoon-Cassini and her associates scoured existing medical literature on the topic to review risk factors and created an item pool of questions based on those risk factors. They came up with 47 items and statistically “funneled out the items to create the most parsimonious model predicting who goes on to develop PTSD and depression separately,” she explained. They then created the Injured Trauma Survivor Screen (ITSS), a nine-item list of yes/no questions that takes about 5 minutes to administer: five items for PTSD and five items for depression, with one item that overlaps. The five ITSS PTSD questions are:
• Did you think you were going to die? (risk factor being perceived life threat; odds ratio 6.32).
• Do you think this was done to you intentionally? (risk factor being intentionality; OR, 4.24).
• Have you felt more restless, tense, or jumpy than usual? (risk factor being assessment of arousal; OR, 5.31).
• Have you found yourself unable to stop worrying? (risk factor being worry/rumination; OR, 4.49).
• Do you find yourself thinking that the world is unsafe and that people are not to be trusted? (risk factor being negative alterations in cognition; OR, 5.52).
The five ITSS depression questions are:
• Have you ever taken medication for, or been given a mental health diagnosis? (risk factor being preexisting psychopathology; OR, 10.58).
• Has there ever been a time in your life you have been bothered by feeling down or hopeless or lost all interest in things you usually enjoyed for more than 2 weeks? (risk factor being premorbid depression; OR, 3.78).
• Did you think you were going to die? (risk factor being perceived life threat; OR, 9.69).
• Have you felt emotionally detached from your loved ones? (risk factor being negative alteration in mood; OR, 8.03).
• Do you find yourself crying and are unsure why? (risk factor being mood/depression; OR, 9.18).
The researchers administered the survey to 139 patients at two trauma centers. More than half (69%) were male, 48% were white, 40% were African American, and the remainder were from other ethnic backgrounds. The three most common mechanisms of injury were motor vehicle crashes (29%), motorcycle/all-terrain vehicle crashes (19%), and falls (13%). Dr. deRoon-Cassini reported that administration of the ITSS within 4 days of injury demonstrated a 75% sensitivity for identifying the risk for PTSD and depression, a 94% specificity for PTSD, and a 96% specificity for depression, with a cutoff score of 2 out of 5 for both subscales based on a receiver operating characteristic (ROC) curve analysis.
One month following administration of the ITSS, 20% of patients were diagnosed with depression and 29% were diagnosed with PTSD. Of those diagnosed with PTSD, 55% met criteria for concomitant depression “so we are seeing a high comorbidity between PTSD and depression, which is consistent with the medical literature,” she said.
“The ITSS represents a brief way that we can screen for PTSD and depression within a trauma system,” Dr. deRoon-Cassini said. “At our institution, social workers administer the tool. They have a flow sheet in our EMR system where they enter the responses. If someone screens positive, a best practice recommendation is put into the patient’s chart, which gets funneled to a trauma psychology consult. On the treatment side we try to intervene by triaging the severity of the current distress the person is experiencing, past comorbidities, and past trauma histories. From there we decide whether to do a brief intervention or more intensive evidence-based interventions for PTSD or depression together or separately.”
The study was funded by a grant from the Medical College of Wisconsin. Coauthors included Joshua Hunt, PhD, of the Medical College of Wisconsin, Milwaukee; Ann Marie Warren, PhD, of Baylor Medical Center, Dallas; and Karen Brasel, MD, FACS, of Oregon Health & Science University, Portland. Dr. deRoon-Cassini reported having no financial disclosures.
WAIKOLOA, HAWAII – A new nine-item tool known as the Injured Trauma Survivor Screen demonstrated strong sensitivity and specificity for predicting posttraumatic stress disorder and depression in trauma patients.
At the annual meeting of the American Association for the Surgery of Trauma, Terri deRoon-Cassini, PhD, said that the rates of PTSD among trauma patients range from 10% to 42%, depending on the type of injury sustained. “There is significant life impairment, including an increased risk for suicide and an increased risk for morbidity and mortality,” said Dr. deRoon-Cassini, a clinical psychologist and associate professor with the division of trauma and critical care at the Medical College of Wisconsin, Milwaukee.
The ACS Committee on Trauma currently recommends PTSD screening by trauma centers, including the 20-item PTSD Checklist and the nine-item PHD-9 for depression. However, these symptom-based screens were not validated in hospitalized trauma patients. “This becomes important, because according to the symptom trajectory of PTSD after trauma, about 22% of people experience chronic disease and about 16%-18% of people who have symptoms at baseline do not translate to symptoms by 6 months, so screening with a symptom-based measure isn’t always the best route,” she said.
In an effort to create a brief screening tool to identify those at risk for PTSD and depression following traumatic injury, Dr. deRoon-Cassini and her associates scoured existing medical literature on the topic to review risk factors and created an item pool of questions based on those risk factors. They came up with 47 items and statistically “funneled out the items to create the most parsimonious model predicting who goes on to develop PTSD and depression separately,” she explained. They then created the Injured Trauma Survivor Screen (ITSS), a nine-item list of yes/no questions that takes about 5 minutes to administer: five items for PTSD and five items for depression, with one item that overlaps. The five ITSS PTSD questions are:
• Did you think you were going to die? (risk factor being perceived life threat; odds ratio 6.32).
• Do you think this was done to you intentionally? (risk factor being intentionality; OR, 4.24).
• Have you felt more restless, tense, or jumpy than usual? (risk factor being assessment of arousal; OR, 5.31).
• Have you found yourself unable to stop worrying? (risk factor being worry/rumination; OR, 4.49).
• Do you find yourself thinking that the world is unsafe and that people are not to be trusted? (risk factor being negative alterations in cognition; OR, 5.52).
The five ITSS depression questions are:
• Have you ever taken medication for, or been given a mental health diagnosis? (risk factor being preexisting psychopathology; OR, 10.58).
• Has there ever been a time in your life you have been bothered by feeling down or hopeless or lost all interest in things you usually enjoyed for more than 2 weeks? (risk factor being premorbid depression; OR, 3.78).
• Did you think you were going to die? (risk factor being perceived life threat; OR, 9.69).
• Have you felt emotionally detached from your loved ones? (risk factor being negative alteration in mood; OR, 8.03).
• Do you find yourself crying and are unsure why? (risk factor being mood/depression; OR, 9.18).
The researchers administered the survey to 139 patients at two trauma centers. More than half (69%) were male, 48% were white, 40% were African American, and the remainder were from other ethnic backgrounds. The three most common mechanisms of injury were motor vehicle crashes (29%), motorcycle/all-terrain vehicle crashes (19%), and falls (13%). Dr. deRoon-Cassini reported that administration of the ITSS within 4 days of injury demonstrated a 75% sensitivity for identifying the risk for PTSD and depression, a 94% specificity for PTSD, and a 96% specificity for depression, with a cutoff score of 2 out of 5 for both subscales based on a receiver operating characteristic (ROC) curve analysis.
One month following administration of the ITSS, 20% of patients were diagnosed with depression and 29% were diagnosed with PTSD. Of those diagnosed with PTSD, 55% met criteria for concomitant depression “so we are seeing a high comorbidity between PTSD and depression, which is consistent with the medical literature,” she said.
“The ITSS represents a brief way that we can screen for PTSD and depression within a trauma system,” Dr. deRoon-Cassini said. “At our institution, social workers administer the tool. They have a flow sheet in our EMR system where they enter the responses. If someone screens positive, a best practice recommendation is put into the patient’s chart, which gets funneled to a trauma psychology consult. On the treatment side we try to intervene by triaging the severity of the current distress the person is experiencing, past comorbidities, and past trauma histories. From there we decide whether to do a brief intervention or more intensive evidence-based interventions for PTSD or depression together or separately.”
The study was funded by a grant from the Medical College of Wisconsin. Coauthors included Joshua Hunt, PhD, of the Medical College of Wisconsin, Milwaukee; Ann Marie Warren, PhD, of Baylor Medical Center, Dallas; and Karen Brasel, MD, FACS, of Oregon Health & Science University, Portland. Dr. deRoon-Cassini reported having no financial disclosures.
Key clinical point:
Major finding: Administration of the Injured Trauma Survivor Screen (ITSS) within 4 days of injury demonstrated a 75% sensitivity for identifying the risk for PTSD and depression, a 94% specificity for PTSD, and a 96% specificity for depression.
Data source: An analysis of 139 patients from two trauma centers who completed the ITSS.
Disclosures: The study was funded by a grant from the Medical College of Wisconsin. Dr. deRoon-Cassini reported having no financial disclosures.
AHA: Midlife hypertension linked with cognitive impairment
Unchecked hypertension has “devastating” long-term implications for cognitive health, the American Heart Association concluded in a scientific statement.
“Hypertension disrupts the structure and function of cerebral blood vessels, leads to ischemic damage of white matter regions critical for cognitive function, and may promote Alzheimer pathology,” Costantino Iadecola, MD, of Weill Medical College of Cornell University, wrote online with his associates in Hypertension. There is especially strong evidence that hypertension in middle age leads to cognitive dysfunction later in life, although “the cognitive impact of late-life hypertension is less clear,” they said.
The AHA statement summarizes the current evidence on hypertension, cognitive impairment, and the cognitive effects of hypertension therapy. Observational studies linked hypertension to cumulative cerebrovascular damage over the course of life, but clinical trials did not clearly show that antihypertensive drugs can prevent or reverse cognitive decline, the authors reported. In lieu of making evidence-based recommendations, they emphasized “personalized treatment of hypertension, taking into account age, sex, APOE [apolipoprotein E] genotype, metabolic traits, [and] comorbidities” (Hypertension. 2016 Oct 10. doi: 10.1161/HYP.0000000000000053).
The authors wrote on behalf of the American Heart Association Councils on Hypertension, Clinical Cardiology, Cardiovascular Disease in the Young, Cardiovascular and Stroke Nursing, and Quality of Care and Outcomes Research, and Stroke. Dr. Iadecola and nine coauthors had no relevant financial disclosures. The remaining three coauthors disclosed research funding from the National Institutes of Health, Lilly, TauRX, and Biogen, and one of these coauthors also disclosed consulting or advisory board work for Lundbeck Pharmaceuticals and the Dominantly Inherited Alzheimer Network Trials Unit.
Unchecked hypertension has “devastating” long-term implications for cognitive health, the American Heart Association concluded in a scientific statement.
“Hypertension disrupts the structure and function of cerebral blood vessels, leads to ischemic damage of white matter regions critical for cognitive function, and may promote Alzheimer pathology,” Costantino Iadecola, MD, of Weill Medical College of Cornell University, wrote online with his associates in Hypertension. There is especially strong evidence that hypertension in middle age leads to cognitive dysfunction later in life, although “the cognitive impact of late-life hypertension is less clear,” they said.
The AHA statement summarizes the current evidence on hypertension, cognitive impairment, and the cognitive effects of hypertension therapy. Observational studies linked hypertension to cumulative cerebrovascular damage over the course of life, but clinical trials did not clearly show that antihypertensive drugs can prevent or reverse cognitive decline, the authors reported. In lieu of making evidence-based recommendations, they emphasized “personalized treatment of hypertension, taking into account age, sex, APOE [apolipoprotein E] genotype, metabolic traits, [and] comorbidities” (Hypertension. 2016 Oct 10. doi: 10.1161/HYP.0000000000000053).
The authors wrote on behalf of the American Heart Association Councils on Hypertension, Clinical Cardiology, Cardiovascular Disease in the Young, Cardiovascular and Stroke Nursing, and Quality of Care and Outcomes Research, and Stroke. Dr. Iadecola and nine coauthors had no relevant financial disclosures. The remaining three coauthors disclosed research funding from the National Institutes of Health, Lilly, TauRX, and Biogen, and one of these coauthors also disclosed consulting or advisory board work for Lundbeck Pharmaceuticals and the Dominantly Inherited Alzheimer Network Trials Unit.
Unchecked hypertension has “devastating” long-term implications for cognitive health, the American Heart Association concluded in a scientific statement.
“Hypertension disrupts the structure and function of cerebral blood vessels, leads to ischemic damage of white matter regions critical for cognitive function, and may promote Alzheimer pathology,” Costantino Iadecola, MD, of Weill Medical College of Cornell University, wrote online with his associates in Hypertension. There is especially strong evidence that hypertension in middle age leads to cognitive dysfunction later in life, although “the cognitive impact of late-life hypertension is less clear,” they said.
The AHA statement summarizes the current evidence on hypertension, cognitive impairment, and the cognitive effects of hypertension therapy. Observational studies linked hypertension to cumulative cerebrovascular damage over the course of life, but clinical trials did not clearly show that antihypertensive drugs can prevent or reverse cognitive decline, the authors reported. In lieu of making evidence-based recommendations, they emphasized “personalized treatment of hypertension, taking into account age, sex, APOE [apolipoprotein E] genotype, metabolic traits, [and] comorbidities” (Hypertension. 2016 Oct 10. doi: 10.1161/HYP.0000000000000053).
The authors wrote on behalf of the American Heart Association Councils on Hypertension, Clinical Cardiology, Cardiovascular Disease in the Young, Cardiovascular and Stroke Nursing, and Quality of Care and Outcomes Research, and Stroke. Dr. Iadecola and nine coauthors had no relevant financial disclosures. The remaining three coauthors disclosed research funding from the National Institutes of Health, Lilly, TauRX, and Biogen, and one of these coauthors also disclosed consulting or advisory board work for Lundbeck Pharmaceuticals and the Dominantly Inherited Alzheimer Network Trials Unit.
Preperitoneal pelvic packing benefits subset of pelvic fracture patients
WAIKOLOA, HAWAII – Preperitoneal pelvic packing reduces mortality in patients with life-threatening hemorrhage caused by unstable pelvic fractures, results from a long-term single-center study showed.
“Despite advances in care of the critically injured patient, mortality rates for patients with hemodynamic instability due to pelvic fractures remains greater than 30%,” Clay Cothren Burlew, MD, said at the annual meeting of the American Association for the Surgery of Trauma. “The majority of trauma centers in the United States use angioembolization for hemorrhage control. While angioembolization is effective in controlling arterial sources of hemorrhage, which constitutes about 15% of pelvic bleeding, it does not address the venous or bony sources of hemorrhage within the pelvis. Additionally, time to arterial hemorrhage control using angioembolization usually takes several hours to accomplish, even at the most advanced level I trauma centers.”
For the current study, the researchers hypothesized that pelvic packing would result in a shorter time to intervention and lower mortality, compared with other pelvic fracture management strategies.
Since September 2004 all patients at the Denver Health Medical Center with persistent hemodynamic instability and a pelvic fracture underwent pelvic packing. Indication for packing is a persistent systolic blood pressure of less than 90 mm Hg in the initial resuscitation period despite the transfusion of two units of red blood cells. “Initial stabilization of the pelvis is performed in the emergency department with a pelvic sheet or a binder,” Dr. Burlew explained. “Skeletal fixation of the pelvis with an external fixator or a pelvic C clamp is done concurrently with preperitoneal pelvic packing in the operating room. Angiography is performed for ongoing pelvic bleeding, defined as greater than four units of red blood cells after the patients’ coagulopathy is corrected; immediate postpacking angiography is performed for ongoing hemodynamic instability despite packing and external fixation.”
Over a period of 11 years, 2,293 patients were admitted to Denver Health Medical Center with pelvic fractures. Of these, 128 patients in refractory shock underwent pelvic packing. More than half of the patients (70%) were men, their mean age was 44 years, and their mean Injury Severity Score was 48. The most common mechanism of injury was motor vehicle collision, followed by auto/pedestrian accidents and motorcycle collision. Pelvic fracture patterns included every classification, with anterior posterior compression (APC) III and lateral compression (LC) II patterns predominating. Of these, 18 patients had open pelvic fractures. More than half of patients (70%) had an extremity injury, 65% had a thoracic injury, 63% had an abdominal injury, 43% had a traumatic brain injury, and 38% had a spine injury.
The mean systolic blood pressure of patients was 74 mm Hg and their mean heart rate was 120 beats per minute in the emergency department. Their mean base deficit was 12. However, 32% of patients did not have an arterial blood gas reported during this time frame. When the researchers compared 13% of patients who underwent postpacking angioembolization with those who did not require angioembolization after pelvic packing, they observed no significant differences in age, injury severity score, presenting systolic BP, presenting systolic BP/base deficit, or ED transfusions. The only difference that reached statistical significance was a lower heart rate in the ED in the postpacking angioembolization group, compared with the preperitoneal pelvic packing alone group (110 vs. 121 beats per minute). “We also realized that the angioembolization group received more red blood cells and fresh frozen plasma prior to ICU admission, as well as in the subsequent 24 hours,” Dr. Burlew said.
The majority of patients (84%) had a single packing of the preperitoneal space, while 20 patients underwent repacking when returned to the operating room; all occurred prior to July 2011. “At this time point we determined that there was an increased infection rate with repacking of the pelvis,” Dr. Burlew said. “There were 15 pelvic space infections. Four occurred in those with open fractures or perineal degloving, four developed in those with associated bladder injuries, and seven pelvic space infections occurred in patients without an open fracture.” The infection rate was 6% among patients with a single packing of the pelvis, compared with an infection rate of 45% among those who underwent repacking. “This emphasizes the need for local control of small bleeders when the pelvis in unpacked, using electrocautery and topical hemostatic agents,” she said.
Dr. Burlew went on to note that comparison of two prospective observational study groups with differing management schema may provide salient information. “The AAST multicenter study was an evaluation of the modern-day care of pelvic fracture patients from 11 different centers,” she said. “In that study, the mortality rate among patients presenting in shock who did not undergo pelvic packing was 32%. The mortality rate in our series was 21%, with a relative risk reduction that was statistically significant.” She concluded that pelvic packing “has a faster time to intervention for pelvic fracture–related hemorrhage. Arterial bleed was only present in 13% of patients, rendering angiography of limited utility. Pelvic packing should be utilized for pelvic fracture–related bleeding in the patient who remains hemodynamically unstable despite red blood cell transfusion.”
One of the study authors, Ernest E. Moore, MD, disclosed that he has received research funding from Haemonetics, TEM, and Prytime Medical Devices, and Charles J. Fox, MD, is on the clinical advisory board for Prytime Medical Devices. Dr. Burlew reported having no financial disclosures.
WAIKOLOA, HAWAII – Preperitoneal pelvic packing reduces mortality in patients with life-threatening hemorrhage caused by unstable pelvic fractures, results from a long-term single-center study showed.
“Despite advances in care of the critically injured patient, mortality rates for patients with hemodynamic instability due to pelvic fractures remains greater than 30%,” Clay Cothren Burlew, MD, said at the annual meeting of the American Association for the Surgery of Trauma. “The majority of trauma centers in the United States use angioembolization for hemorrhage control. While angioembolization is effective in controlling arterial sources of hemorrhage, which constitutes about 15% of pelvic bleeding, it does not address the venous or bony sources of hemorrhage within the pelvis. Additionally, time to arterial hemorrhage control using angioembolization usually takes several hours to accomplish, even at the most advanced level I trauma centers.”
For the current study, the researchers hypothesized that pelvic packing would result in a shorter time to intervention and lower mortality, compared with other pelvic fracture management strategies.
Since September 2004 all patients at the Denver Health Medical Center with persistent hemodynamic instability and a pelvic fracture underwent pelvic packing. Indication for packing is a persistent systolic blood pressure of less than 90 mm Hg in the initial resuscitation period despite the transfusion of two units of red blood cells. “Initial stabilization of the pelvis is performed in the emergency department with a pelvic sheet or a binder,” Dr. Burlew explained. “Skeletal fixation of the pelvis with an external fixator or a pelvic C clamp is done concurrently with preperitoneal pelvic packing in the operating room. Angiography is performed for ongoing pelvic bleeding, defined as greater than four units of red blood cells after the patients’ coagulopathy is corrected; immediate postpacking angiography is performed for ongoing hemodynamic instability despite packing and external fixation.”
Over a period of 11 years, 2,293 patients were admitted to Denver Health Medical Center with pelvic fractures. Of these, 128 patients in refractory shock underwent pelvic packing. More than half of the patients (70%) were men, their mean age was 44 years, and their mean Injury Severity Score was 48. The most common mechanism of injury was motor vehicle collision, followed by auto/pedestrian accidents and motorcycle collision. Pelvic fracture patterns included every classification, with anterior posterior compression (APC) III and lateral compression (LC) II patterns predominating. Of these, 18 patients had open pelvic fractures. More than half of patients (70%) had an extremity injury, 65% had a thoracic injury, 63% had an abdominal injury, 43% had a traumatic brain injury, and 38% had a spine injury.
The mean systolic blood pressure of patients was 74 mm Hg and their mean heart rate was 120 beats per minute in the emergency department. Their mean base deficit was 12. However, 32% of patients did not have an arterial blood gas reported during this time frame. When the researchers compared 13% of patients who underwent postpacking angioembolization with those who did not require angioembolization after pelvic packing, they observed no significant differences in age, injury severity score, presenting systolic BP, presenting systolic BP/base deficit, or ED transfusions. The only difference that reached statistical significance was a lower heart rate in the ED in the postpacking angioembolization group, compared with the preperitoneal pelvic packing alone group (110 vs. 121 beats per minute). “We also realized that the angioembolization group received more red blood cells and fresh frozen plasma prior to ICU admission, as well as in the subsequent 24 hours,” Dr. Burlew said.
The majority of patients (84%) had a single packing of the preperitoneal space, while 20 patients underwent repacking when returned to the operating room; all occurred prior to July 2011. “At this time point we determined that there was an increased infection rate with repacking of the pelvis,” Dr. Burlew said. “There were 15 pelvic space infections. Four occurred in those with open fractures or perineal degloving, four developed in those with associated bladder injuries, and seven pelvic space infections occurred in patients without an open fracture.” The infection rate was 6% among patients with a single packing of the pelvis, compared with an infection rate of 45% among those who underwent repacking. “This emphasizes the need for local control of small bleeders when the pelvis in unpacked, using electrocautery and topical hemostatic agents,” she said.
Dr. Burlew went on to note that comparison of two prospective observational study groups with differing management schema may provide salient information. “The AAST multicenter study was an evaluation of the modern-day care of pelvic fracture patients from 11 different centers,” she said. “In that study, the mortality rate among patients presenting in shock who did not undergo pelvic packing was 32%. The mortality rate in our series was 21%, with a relative risk reduction that was statistically significant.” She concluded that pelvic packing “has a faster time to intervention for pelvic fracture–related hemorrhage. Arterial bleed was only present in 13% of patients, rendering angiography of limited utility. Pelvic packing should be utilized for pelvic fracture–related bleeding in the patient who remains hemodynamically unstable despite red blood cell transfusion.”
One of the study authors, Ernest E. Moore, MD, disclosed that he has received research funding from Haemonetics, TEM, and Prytime Medical Devices, and Charles J. Fox, MD, is on the clinical advisory board for Prytime Medical Devices. Dr. Burlew reported having no financial disclosures.
WAIKOLOA, HAWAII – Preperitoneal pelvic packing reduces mortality in patients with life-threatening hemorrhage caused by unstable pelvic fractures, results from a long-term single-center study showed.
“Despite advances in care of the critically injured patient, mortality rates for patients with hemodynamic instability due to pelvic fractures remains greater than 30%,” Clay Cothren Burlew, MD, said at the annual meeting of the American Association for the Surgery of Trauma. “The majority of trauma centers in the United States use angioembolization for hemorrhage control. While angioembolization is effective in controlling arterial sources of hemorrhage, which constitutes about 15% of pelvic bleeding, it does not address the venous or bony sources of hemorrhage within the pelvis. Additionally, time to arterial hemorrhage control using angioembolization usually takes several hours to accomplish, even at the most advanced level I trauma centers.”
For the current study, the researchers hypothesized that pelvic packing would result in a shorter time to intervention and lower mortality, compared with other pelvic fracture management strategies.
Since September 2004 all patients at the Denver Health Medical Center with persistent hemodynamic instability and a pelvic fracture underwent pelvic packing. Indication for packing is a persistent systolic blood pressure of less than 90 mm Hg in the initial resuscitation period despite the transfusion of two units of red blood cells. “Initial stabilization of the pelvis is performed in the emergency department with a pelvic sheet or a binder,” Dr. Burlew explained. “Skeletal fixation of the pelvis with an external fixator or a pelvic C clamp is done concurrently with preperitoneal pelvic packing in the operating room. Angiography is performed for ongoing pelvic bleeding, defined as greater than four units of red blood cells after the patients’ coagulopathy is corrected; immediate postpacking angiography is performed for ongoing hemodynamic instability despite packing and external fixation.”
Over a period of 11 years, 2,293 patients were admitted to Denver Health Medical Center with pelvic fractures. Of these, 128 patients in refractory shock underwent pelvic packing. More than half of the patients (70%) were men, their mean age was 44 years, and their mean Injury Severity Score was 48. The most common mechanism of injury was motor vehicle collision, followed by auto/pedestrian accidents and motorcycle collision. Pelvic fracture patterns included every classification, with anterior posterior compression (APC) III and lateral compression (LC) II patterns predominating. Of these, 18 patients had open pelvic fractures. More than half of patients (70%) had an extremity injury, 65% had a thoracic injury, 63% had an abdominal injury, 43% had a traumatic brain injury, and 38% had a spine injury.
The mean systolic blood pressure of patients was 74 mm Hg and their mean heart rate was 120 beats per minute in the emergency department. Their mean base deficit was 12. However, 32% of patients did not have an arterial blood gas reported during this time frame. When the researchers compared 13% of patients who underwent postpacking angioembolization with those who did not require angioembolization after pelvic packing, they observed no significant differences in age, injury severity score, presenting systolic BP, presenting systolic BP/base deficit, or ED transfusions. The only difference that reached statistical significance was a lower heart rate in the ED in the postpacking angioembolization group, compared with the preperitoneal pelvic packing alone group (110 vs. 121 beats per minute). “We also realized that the angioembolization group received more red blood cells and fresh frozen plasma prior to ICU admission, as well as in the subsequent 24 hours,” Dr. Burlew said.
The majority of patients (84%) had a single packing of the preperitoneal space, while 20 patients underwent repacking when returned to the operating room; all occurred prior to July 2011. “At this time point we determined that there was an increased infection rate with repacking of the pelvis,” Dr. Burlew said. “There were 15 pelvic space infections. Four occurred in those with open fractures or perineal degloving, four developed in those with associated bladder injuries, and seven pelvic space infections occurred in patients without an open fracture.” The infection rate was 6% among patients with a single packing of the pelvis, compared with an infection rate of 45% among those who underwent repacking. “This emphasizes the need for local control of small bleeders when the pelvis in unpacked, using electrocautery and topical hemostatic agents,” she said.
Dr. Burlew went on to note that comparison of two prospective observational study groups with differing management schema may provide salient information. “The AAST multicenter study was an evaluation of the modern-day care of pelvic fracture patients from 11 different centers,” she said. “In that study, the mortality rate among patients presenting in shock who did not undergo pelvic packing was 32%. The mortality rate in our series was 21%, with a relative risk reduction that was statistically significant.” She concluded that pelvic packing “has a faster time to intervention for pelvic fracture–related hemorrhage. Arterial bleed was only present in 13% of patients, rendering angiography of limited utility. Pelvic packing should be utilized for pelvic fracture–related bleeding in the patient who remains hemodynamically unstable despite red blood cell transfusion.”
One of the study authors, Ernest E. Moore, MD, disclosed that he has received research funding from Haemonetics, TEM, and Prytime Medical Devices, and Charles J. Fox, MD, is on the clinical advisory board for Prytime Medical Devices. Dr. Burlew reported having no financial disclosures.
Key clinical point:
Major finding: Of the 128 patients who underwent preperitoneal pelvic packing for life-threatening hemorrhage caused by unstable pelvic fractures, 27 died, for a mortality rate of 21%, which is significantly lower than other analyses in the medical literature.
Data source: An 11-year study of 2,293 patients who were admitted to Denver Health Medical Center with pelvic fractures.
Disclosures: One of the study authors, Ernest E. Moore, MD, disclosed that he has received research funding from Haemonetics, TEM, and Prytime Medical Devices, and Charles J. Fox, MD, is on the clinical advisory board for Prytime Medical Devices. Dr. Burlew reported having no financial disclosures.
CMS assures small-practice doctors they have a place in MACRA
WASHINGTON – Fear over how Medicare officials will operationalize the Medicare Access and CHIP Reauthorization Act – known as MACRA – should not be driving physicians in small and solo practices to become employees of large systems, a top federal health official said.
“If people want to sell their practices and they want to [be a] part of integrated care models for other reasons, that’s fine,” Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services said during an Oct. 6 event hosted by the Association of Health Care Journalists. “I think we have to make a really big effort though to make sure that they are not being driven there because the world’s getting too complicated ... and they throw up their hands.”
“There are people throwing fear. There are consultants and there are hospitals saying MACRA is going to be impossible,” Mr. Slavitt said. “They don’t know the support that’s going to be provided. It is in certain people’s interest to put the story forward that small physician practices are doomed.”
One aspect of that support has already been announced – that physicians will have flexibility in terms of how much, or how little, they want to participate in the reporting requirements if they are selecting the Merit-based Incentive Payment System in 2017.
While it will be a challenge, Mr. Slavitt said the final MACRA regulations – due out in early November – will support small and solo practices so that they can be successful in the program.
“Health care has become more and more of a business and it becomes harder and harder if you don’t have those kinds of operations. But there are other ways to do it and I think we are going to be successful in a lot of ways,” he said.
WASHINGTON – Fear over how Medicare officials will operationalize the Medicare Access and CHIP Reauthorization Act – known as MACRA – should not be driving physicians in small and solo practices to become employees of large systems, a top federal health official said.
“If people want to sell their practices and they want to [be a] part of integrated care models for other reasons, that’s fine,” Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services said during an Oct. 6 event hosted by the Association of Health Care Journalists. “I think we have to make a really big effort though to make sure that they are not being driven there because the world’s getting too complicated ... and they throw up their hands.”
“There are people throwing fear. There are consultants and there are hospitals saying MACRA is going to be impossible,” Mr. Slavitt said. “They don’t know the support that’s going to be provided. It is in certain people’s interest to put the story forward that small physician practices are doomed.”
One aspect of that support has already been announced – that physicians will have flexibility in terms of how much, or how little, they want to participate in the reporting requirements if they are selecting the Merit-based Incentive Payment System in 2017.
While it will be a challenge, Mr. Slavitt said the final MACRA regulations – due out in early November – will support small and solo practices so that they can be successful in the program.
“Health care has become more and more of a business and it becomes harder and harder if you don’t have those kinds of operations. But there are other ways to do it and I think we are going to be successful in a lot of ways,” he said.
WASHINGTON – Fear over how Medicare officials will operationalize the Medicare Access and CHIP Reauthorization Act – known as MACRA – should not be driving physicians in small and solo practices to become employees of large systems, a top federal health official said.
“If people want to sell their practices and they want to [be a] part of integrated care models for other reasons, that’s fine,” Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services said during an Oct. 6 event hosted by the Association of Health Care Journalists. “I think we have to make a really big effort though to make sure that they are not being driven there because the world’s getting too complicated ... and they throw up their hands.”
“There are people throwing fear. There are consultants and there are hospitals saying MACRA is going to be impossible,” Mr. Slavitt said. “They don’t know the support that’s going to be provided. It is in certain people’s interest to put the story forward that small physician practices are doomed.”
One aspect of that support has already been announced – that physicians will have flexibility in terms of how much, or how little, they want to participate in the reporting requirements if they are selecting the Merit-based Incentive Payment System in 2017.
While it will be a challenge, Mr. Slavitt said the final MACRA regulations – due out in early November – will support small and solo practices so that they can be successful in the program.
“Health care has become more and more of a business and it becomes harder and harder if you don’t have those kinds of operations. But there are other ways to do it and I think we are going to be successful in a lot of ways,” he said.