Procalcitonin Nears Prime Time

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Clinical question: What is the relationship between procalcitonin (ProCT) levels and radiographic abnormalities in patients with suspected pneumonia?

Background: Pneumonia is a common clinical diagnosis and reason for admission to the hospital. In a number of cases, however, chest X-rays might not conclusively show an infiltrate. The correlation between ProCT levels and X-ray findings has not been well studied.

Study design: Prospective cohort study.

Setting: Tertiary-care U.S. hospital.

Synopsis: In all, 528 patients with acute respiratory illness were enrolled in the study. Both a blinded radiologist and a pulmonologist involved in the care of each patient reviewed the chest films independently. The pulmonologist was more likely to judge that an infiltrate was present. ProCT levels correlated well with the diagnosis of pneumonia and the presence of an infiltrate by chest X-ray. For patients with an indeterminant film, as determined by the radiologist, ProCT levels were higher in those patients in whom the pulmonologist judged an infiltrate was indeed present. Nearly every patient with an indeterminant film received antibiotics.

One limitation of the study was the lack of a clear gold standard for the determination of a pneumonia diagnosis. And as an observational study, it is uncertain what the effect might be of withholding antibiotics from patients with an indeterminant film and low ProCT levels.

Bottom line: Serum procalcitonin levels correlate well with the presence of an infiltrate by chest X-ray and might have a future role for determining whether patients with indeterminant films can be safely treated without antimicrobials.

Citation: Walsh EE, Swinburne AJ, Becker KL, et al. Can serum procalcitonin levels help interpret indeterminate chest radiographs in patients hospitalized with acute respiratory illness? J Hosp Med. 2012. doi:10.1002/jhm.1984 [Epub ahead of print].

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Clinical question: What is the relationship between procalcitonin (ProCT) levels and radiographic abnormalities in patients with suspected pneumonia?

Background: Pneumonia is a common clinical diagnosis and reason for admission to the hospital. In a number of cases, however, chest X-rays might not conclusively show an infiltrate. The correlation between ProCT levels and X-ray findings has not been well studied.

Study design: Prospective cohort study.

Setting: Tertiary-care U.S. hospital.

Synopsis: In all, 528 patients with acute respiratory illness were enrolled in the study. Both a blinded radiologist and a pulmonologist involved in the care of each patient reviewed the chest films independently. The pulmonologist was more likely to judge that an infiltrate was present. ProCT levels correlated well with the diagnosis of pneumonia and the presence of an infiltrate by chest X-ray. For patients with an indeterminant film, as determined by the radiologist, ProCT levels were higher in those patients in whom the pulmonologist judged an infiltrate was indeed present. Nearly every patient with an indeterminant film received antibiotics.

One limitation of the study was the lack of a clear gold standard for the determination of a pneumonia diagnosis. And as an observational study, it is uncertain what the effect might be of withholding antibiotics from patients with an indeterminant film and low ProCT levels.

Bottom line: Serum procalcitonin levels correlate well with the presence of an infiltrate by chest X-ray and might have a future role for determining whether patients with indeterminant films can be safely treated without antimicrobials.

Citation: Walsh EE, Swinburne AJ, Becker KL, et al. Can serum procalcitonin levels help interpret indeterminate chest radiographs in patients hospitalized with acute respiratory illness? J Hosp Med. 2012. doi:10.1002/jhm.1984 [Epub ahead of print].

Clinical question: What is the relationship between procalcitonin (ProCT) levels and radiographic abnormalities in patients with suspected pneumonia?

Background: Pneumonia is a common clinical diagnosis and reason for admission to the hospital. In a number of cases, however, chest X-rays might not conclusively show an infiltrate. The correlation between ProCT levels and X-ray findings has not been well studied.

Study design: Prospective cohort study.

Setting: Tertiary-care U.S. hospital.

Synopsis: In all, 528 patients with acute respiratory illness were enrolled in the study. Both a blinded radiologist and a pulmonologist involved in the care of each patient reviewed the chest films independently. The pulmonologist was more likely to judge that an infiltrate was present. ProCT levels correlated well with the diagnosis of pneumonia and the presence of an infiltrate by chest X-ray. For patients with an indeterminant film, as determined by the radiologist, ProCT levels were higher in those patients in whom the pulmonologist judged an infiltrate was indeed present. Nearly every patient with an indeterminant film received antibiotics.

One limitation of the study was the lack of a clear gold standard for the determination of a pneumonia diagnosis. And as an observational study, it is uncertain what the effect might be of withholding antibiotics from patients with an indeterminant film and low ProCT levels.

Bottom line: Serum procalcitonin levels correlate well with the presence of an infiltrate by chest X-ray and might have a future role for determining whether patients with indeterminant films can be safely treated without antimicrobials.

Citation: Walsh EE, Swinburne AJ, Becker KL, et al. Can serum procalcitonin levels help interpret indeterminate chest radiographs in patients hospitalized with acute respiratory illness? J Hosp Med. 2012. doi:10.1002/jhm.1984 [Epub ahead of print].

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Readmission after Initial Injury Is Common

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Readmission after Initial Injury Is Common

Clinical question: How frequently are patients readmitted after an initial inpatient stay for an injury, and what factors might predict readmission?

Background: Readmission to the hospital is a vexing healthcare problem prompting substantial investigation into factors that predict readmission after a medical or surgical illness. Data regarding readmission rates following injuries are lacking, as is our understanding of the factors that predict these readmissions.

Study design: Retrospective cohort study.

Setting: Hospitals in 11 U.S. states participating in the 2006 Healthcare Cost and Utilization Project State Inpatient Databases and State Emergency Department Databases.

Synopsis: The authors studied more than 200,000 patients aged 65 and older admitted to the hospital with an injury. Fracture was the most common injury (75%) and falls were the most common mechanism of injury (75%). The overall 30-day readmission rate was 13.7%, or about 1 in 7, which is below the rate commonly seen with medical illnesses.

The most common reasons for readmission were surgery (7.4%) and pneumonia (7.2%). Factors that predicted readmission included an initially “moderate” or “severe” injury, as defined by the validated New Injury Severity Score, the need for blood transfusion during admission, the presence of an infection, and the occurrence of a patient safety event, such as a fall. Discharge to a nursing home was associated with increased risk for readmission.

Bottom line: Readmission after an acute injury is less common than after a medical illness but still occurred in 1 in 7 patients.

Citation: Spector WD, Mutter R, Owens P, Limcangco R. Thirty-day, all-cause readmissions for elderly patients who have an injury-related inpatient stay. Med Care. 2012;50:863-869.

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Clinical question: How frequently are patients readmitted after an initial inpatient stay for an injury, and what factors might predict readmission?

Background: Readmission to the hospital is a vexing healthcare problem prompting substantial investigation into factors that predict readmission after a medical or surgical illness. Data regarding readmission rates following injuries are lacking, as is our understanding of the factors that predict these readmissions.

Study design: Retrospective cohort study.

Setting: Hospitals in 11 U.S. states participating in the 2006 Healthcare Cost and Utilization Project State Inpatient Databases and State Emergency Department Databases.

Synopsis: The authors studied more than 200,000 patients aged 65 and older admitted to the hospital with an injury. Fracture was the most common injury (75%) and falls were the most common mechanism of injury (75%). The overall 30-day readmission rate was 13.7%, or about 1 in 7, which is below the rate commonly seen with medical illnesses.

The most common reasons for readmission were surgery (7.4%) and pneumonia (7.2%). Factors that predicted readmission included an initially “moderate” or “severe” injury, as defined by the validated New Injury Severity Score, the need for blood transfusion during admission, the presence of an infection, and the occurrence of a patient safety event, such as a fall. Discharge to a nursing home was associated with increased risk for readmission.

Bottom line: Readmission after an acute injury is less common than after a medical illness but still occurred in 1 in 7 patients.

Citation: Spector WD, Mutter R, Owens P, Limcangco R. Thirty-day, all-cause readmissions for elderly patients who have an injury-related inpatient stay. Med Care. 2012;50:863-869.

Clinical question: How frequently are patients readmitted after an initial inpatient stay for an injury, and what factors might predict readmission?

Background: Readmission to the hospital is a vexing healthcare problem prompting substantial investigation into factors that predict readmission after a medical or surgical illness. Data regarding readmission rates following injuries are lacking, as is our understanding of the factors that predict these readmissions.

Study design: Retrospective cohort study.

Setting: Hospitals in 11 U.S. states participating in the 2006 Healthcare Cost and Utilization Project State Inpatient Databases and State Emergency Department Databases.

Synopsis: The authors studied more than 200,000 patients aged 65 and older admitted to the hospital with an injury. Fracture was the most common injury (75%) and falls were the most common mechanism of injury (75%). The overall 30-day readmission rate was 13.7%, or about 1 in 7, which is below the rate commonly seen with medical illnesses.

The most common reasons for readmission were surgery (7.4%) and pneumonia (7.2%). Factors that predicted readmission included an initially “moderate” or “severe” injury, as defined by the validated New Injury Severity Score, the need for blood transfusion during admission, the presence of an infection, and the occurrence of a patient safety event, such as a fall. Discharge to a nursing home was associated with increased risk for readmission.

Bottom line: Readmission after an acute injury is less common than after a medical illness but still occurred in 1 in 7 patients.

Citation: Spector WD, Mutter R, Owens P, Limcangco R. Thirty-day, all-cause readmissions for elderly patients who have an injury-related inpatient stay. Med Care. 2012;50:863-869.

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Daily Sedation Interruption among Intubated Not Helpful

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Daily Sedation Interruption among Intubated Not Helpful

Clinical question: Does sedation by protocol, in combination with daily sedative interruption, reduce the duration of mechanical ventilation and ICU stay?

Background: Limiting excessive sedation in mechanically ventilated adults is associated with shorter duration of mechanical ventilation and lower risk of delirium. Two strategies to minimize sedation are daily sedation interruptions and protocolized sedation. These strategies have not been evaluated in combination.

Study design: Randomized controlled trial.

Setting: Tertiary-care medical and surgical ICUs in Canada and the U.S.

Synopsis: This randomized controlled trial conducted in 430 critically ill, mechanically ventilated adults at 16 tertiary-care ICUs showed no difference in time to extubation (mean seven days in each group) or ICU length of stay (mean 10 days in each group) in protocolized sedation and sedation interruption compared with protocolized sedation alone. The daily interruption group received higher mean daily doses of midazolam and fentanyl, increased number of boluses of benzodiazepines and opiates, and required increased nurse workload. There was no difference in unintentional endotracheal tube removal or rate of delirium.

A limitation of this study was the use of continuous opioid and/or benzodiazepine infusions instead of bolus dosing. Hospitalists involved in critical care should be careful about changing their practice based on this study alone.

Bottom line: The addition of daily sedation interruptions in mechanically ventilated patients treated with protocolized sedation does not reduce duration of ventilation or ICU stay.

Citation: Mehta S, Burry L, Cook D, et al. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol. JAMA. 2012;308:1985-1992.

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Clinical question: Does sedation by protocol, in combination with daily sedative interruption, reduce the duration of mechanical ventilation and ICU stay?

Background: Limiting excessive sedation in mechanically ventilated adults is associated with shorter duration of mechanical ventilation and lower risk of delirium. Two strategies to minimize sedation are daily sedation interruptions and protocolized sedation. These strategies have not been evaluated in combination.

Study design: Randomized controlled trial.

Setting: Tertiary-care medical and surgical ICUs in Canada and the U.S.

Synopsis: This randomized controlled trial conducted in 430 critically ill, mechanically ventilated adults at 16 tertiary-care ICUs showed no difference in time to extubation (mean seven days in each group) or ICU length of stay (mean 10 days in each group) in protocolized sedation and sedation interruption compared with protocolized sedation alone. The daily interruption group received higher mean daily doses of midazolam and fentanyl, increased number of boluses of benzodiazepines and opiates, and required increased nurse workload. There was no difference in unintentional endotracheal tube removal or rate of delirium.

A limitation of this study was the use of continuous opioid and/or benzodiazepine infusions instead of bolus dosing. Hospitalists involved in critical care should be careful about changing their practice based on this study alone.

Bottom line: The addition of daily sedation interruptions in mechanically ventilated patients treated with protocolized sedation does not reduce duration of ventilation or ICU stay.

Citation: Mehta S, Burry L, Cook D, et al. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol. JAMA. 2012;308:1985-1992.

Clinical question: Does sedation by protocol, in combination with daily sedative interruption, reduce the duration of mechanical ventilation and ICU stay?

Background: Limiting excessive sedation in mechanically ventilated adults is associated with shorter duration of mechanical ventilation and lower risk of delirium. Two strategies to minimize sedation are daily sedation interruptions and protocolized sedation. These strategies have not been evaluated in combination.

Study design: Randomized controlled trial.

Setting: Tertiary-care medical and surgical ICUs in Canada and the U.S.

Synopsis: This randomized controlled trial conducted in 430 critically ill, mechanically ventilated adults at 16 tertiary-care ICUs showed no difference in time to extubation (mean seven days in each group) or ICU length of stay (mean 10 days in each group) in protocolized sedation and sedation interruption compared with protocolized sedation alone. The daily interruption group received higher mean daily doses of midazolam and fentanyl, increased number of boluses of benzodiazepines and opiates, and required increased nurse workload. There was no difference in unintentional endotracheal tube removal or rate of delirium.

A limitation of this study was the use of continuous opioid and/or benzodiazepine infusions instead of bolus dosing. Hospitalists involved in critical care should be careful about changing their practice based on this study alone.

Bottom line: The addition of daily sedation interruptions in mechanically ventilated patients treated with protocolized sedation does not reduce duration of ventilation or ICU stay.

Citation: Mehta S, Burry L, Cook D, et al. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol. JAMA. 2012;308:1985-1992.

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Risk for Falls Might Not Affect Anticoagulation Decision

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Risk for Falls Might Not Affect Anticoagulation Decision

Clinical question: Do patients on oral anticoagulation with high fall risk have an increased incidence of major bleeding?

Background: Despite proven efficacy, oral anticoagulation remains underprescribed. The most commonly cited reasons for not providing oral anticoagulation when clinically indicated are risk of falls and concern for major bleeding.

Study design: Prospective cohort study.

Setting: Internal-medicine inpatient and outpatient services of a university hospital in Switzerland.

Synopsis: This study followed 515 patients on oral anticoagulation for 12 months. Patients at high risk for falls were identified using validated questions known to predict fall risk. Overall, 35 patients had a first major bleed. In multivariate analysis, high fall risk was not associated with an increased incidence of major bleeding (hazard ratio 1.09; 95% confidence interval, 0.54-2.21). Only 1 in 3 fall-related bleeds occurred in the high-fall-risk group.

This study was limited significantly by selection bias. The majority of patients studied already were on anticoagulation therapy for at least three months prior to enrolling in the study, presumably without major bleeding. It is probable that some higher-risk patients were not offered anticoagulation at all and would have been ineligible for the study. This study cohort might have had a lower bleeding risk than members of the general population being started on anticoagulation.

Bottom line: This prospective cohort study shows that patients on oral anticoagulation at high risk of falls did not have significantly increased rates of major bleeding; however, selection bias might have led to an underestimation of bleeding risk. Hospitalists should continue to individualize anticoagulation decisions.

Citation: Donzé J, Clair C, Hug B, et al. Risk of falls and major bleeds in patients on oral anticoagulation therapy. Am J Med. 2012;125:773-778.

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Clinical question: Do patients on oral anticoagulation with high fall risk have an increased incidence of major bleeding?

Background: Despite proven efficacy, oral anticoagulation remains underprescribed. The most commonly cited reasons for not providing oral anticoagulation when clinically indicated are risk of falls and concern for major bleeding.

Study design: Prospective cohort study.

Setting: Internal-medicine inpatient and outpatient services of a university hospital in Switzerland.

Synopsis: This study followed 515 patients on oral anticoagulation for 12 months. Patients at high risk for falls were identified using validated questions known to predict fall risk. Overall, 35 patients had a first major bleed. In multivariate analysis, high fall risk was not associated with an increased incidence of major bleeding (hazard ratio 1.09; 95% confidence interval, 0.54-2.21). Only 1 in 3 fall-related bleeds occurred in the high-fall-risk group.

This study was limited significantly by selection bias. The majority of patients studied already were on anticoagulation therapy for at least three months prior to enrolling in the study, presumably without major bleeding. It is probable that some higher-risk patients were not offered anticoagulation at all and would have been ineligible for the study. This study cohort might have had a lower bleeding risk than members of the general population being started on anticoagulation.

Bottom line: This prospective cohort study shows that patients on oral anticoagulation at high risk of falls did not have significantly increased rates of major bleeding; however, selection bias might have led to an underestimation of bleeding risk. Hospitalists should continue to individualize anticoagulation decisions.

Citation: Donzé J, Clair C, Hug B, et al. Risk of falls and major bleeds in patients on oral anticoagulation therapy. Am J Med. 2012;125:773-778.

Clinical question: Do patients on oral anticoagulation with high fall risk have an increased incidence of major bleeding?

Background: Despite proven efficacy, oral anticoagulation remains underprescribed. The most commonly cited reasons for not providing oral anticoagulation when clinically indicated are risk of falls and concern for major bleeding.

Study design: Prospective cohort study.

Setting: Internal-medicine inpatient and outpatient services of a university hospital in Switzerland.

Synopsis: This study followed 515 patients on oral anticoagulation for 12 months. Patients at high risk for falls were identified using validated questions known to predict fall risk. Overall, 35 patients had a first major bleed. In multivariate analysis, high fall risk was not associated with an increased incidence of major bleeding (hazard ratio 1.09; 95% confidence interval, 0.54-2.21). Only 1 in 3 fall-related bleeds occurred in the high-fall-risk group.

This study was limited significantly by selection bias. The majority of patients studied already were on anticoagulation therapy for at least three months prior to enrolling in the study, presumably without major bleeding. It is probable that some higher-risk patients were not offered anticoagulation at all and would have been ineligible for the study. This study cohort might have had a lower bleeding risk than members of the general population being started on anticoagulation.

Bottom line: This prospective cohort study shows that patients on oral anticoagulation at high risk of falls did not have significantly increased rates of major bleeding; however, selection bias might have led to an underestimation of bleeding risk. Hospitalists should continue to individualize anticoagulation decisions.

Citation: Donzé J, Clair C, Hug B, et al. Risk of falls and major bleeds in patients on oral anticoagulation therapy. Am J Med. 2012;125:773-778.

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Improving Transitions from ED to Inpatient Care

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Improving Transitions from ED to Inpatient Care

Clinical question: Can a multidisciplinary focus group identify “best practices” for ensuring efficient and effective transitions of care between the ED and the inpatient setting?

Background: In the admission process, communication failures can lead to preventable adverse effects. Little has been done to evaluate or improve the interservice handoff between the ED physician and the HM physician.

Study design: Concept article.

Synopsis: Handoffs between ED physicians and HM physicians are complex due to differing pressures, cultures, and expectations. The authors recommend an interactive handoff conversation that is organized, focuses on key principles, and is accompanied by a mutual understanding of the differences between specialties. ED physicians and hospitalists should work together to develop joint expectations on content, delivery, and timing of patient handoffs.

One proposed method includes the current clinical condition of the patient, a working problem statement with degree of certainty and rationale, essential aspects of the history and physical, a brief summary of the ED course, analysis of key tests, pending data with unambiguous assignment for follow-up, and any unusual circumstances. Further research is required to determine if these suggestions improve patient outcomes.

Bottom line: Joint expectations and standardized handoff methods between emergency physicians and hospitalists are likely to foster improved communication and patient care.

Citation: Beach C, Cheung DS, Apker J, et al. Improving inter-unit transitions of care between emergency physicians and hospital medicine physicians: a conceptual approach. Acad Emerg Med. 2012;19:1188-1195.

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Clinical question: Can a multidisciplinary focus group identify “best practices” for ensuring efficient and effective transitions of care between the ED and the inpatient setting?

Background: In the admission process, communication failures can lead to preventable adverse effects. Little has been done to evaluate or improve the interservice handoff between the ED physician and the HM physician.

Study design: Concept article.

Synopsis: Handoffs between ED physicians and HM physicians are complex due to differing pressures, cultures, and expectations. The authors recommend an interactive handoff conversation that is organized, focuses on key principles, and is accompanied by a mutual understanding of the differences between specialties. ED physicians and hospitalists should work together to develop joint expectations on content, delivery, and timing of patient handoffs.

One proposed method includes the current clinical condition of the patient, a working problem statement with degree of certainty and rationale, essential aspects of the history and physical, a brief summary of the ED course, analysis of key tests, pending data with unambiguous assignment for follow-up, and any unusual circumstances. Further research is required to determine if these suggestions improve patient outcomes.

Bottom line: Joint expectations and standardized handoff methods between emergency physicians and hospitalists are likely to foster improved communication and patient care.

Citation: Beach C, Cheung DS, Apker J, et al. Improving inter-unit transitions of care between emergency physicians and hospital medicine physicians: a conceptual approach. Acad Emerg Med. 2012;19:1188-1195.

Clinical question: Can a multidisciplinary focus group identify “best practices” for ensuring efficient and effective transitions of care between the ED and the inpatient setting?

Background: In the admission process, communication failures can lead to preventable adverse effects. Little has been done to evaluate or improve the interservice handoff between the ED physician and the HM physician.

Study design: Concept article.

Synopsis: Handoffs between ED physicians and HM physicians are complex due to differing pressures, cultures, and expectations. The authors recommend an interactive handoff conversation that is organized, focuses on key principles, and is accompanied by a mutual understanding of the differences between specialties. ED physicians and hospitalists should work together to develop joint expectations on content, delivery, and timing of patient handoffs.

One proposed method includes the current clinical condition of the patient, a working problem statement with degree of certainty and rationale, essential aspects of the history and physical, a brief summary of the ED course, analysis of key tests, pending data with unambiguous assignment for follow-up, and any unusual circumstances. Further research is required to determine if these suggestions improve patient outcomes.

Bottom line: Joint expectations and standardized handoff methods between emergency physicians and hospitalists are likely to foster improved communication and patient care.

Citation: Beach C, Cheung DS, Apker J, et al. Improving inter-unit transitions of care between emergency physicians and hospital medicine physicians: a conceptual approach. Acad Emerg Med. 2012;19:1188-1195.

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Serious Complications from Opioid Overuse in Hospitalized Patients Prompts Nationwide Alert

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Opioid overuse can spell the onset of onerous consequences. The analgesics can slow breathing to dangerous levels and lead to dizziness, nausea, and falls.

Citing these concerns, The Joint Commission issued a Sentinel Event Alert in August 2012 that urged hospitals to take specific measures to help avoid serious complications and even deaths from the use of such opioids as morphine, oxycodone, and methadone.

“The Joint Commission recognizes that there is an opportunity to improve the care of patients on opioids in acute-care settings,” spokeswoman Elizabeth Eaken Zhani says. “Healthcare workers need to be aware of the risks to patients in prescribing opioids.”

Adverse events involving opioids include dosing errors and improper monitoring of patients and drug interactions. Patients who have sleep apnea, are obese, or very ill—with such conditions as pulmonary disease, congestive heart failure, or impaired renal function—might be at higher risk for harm from opioids.

Getting opioid pain relief right is critically important, as lives are hanging in the balance on both sides of this problem: Too little pain relief and millions will suffer; too much and lives are at risk.

—Beth B. Murinson, MS, MD, PhD, associate professor, director of pain education, department of neurology, The Johns University Hopkins School of Medicine, Baltimore

“The alert was issued in response to concerns that opioid analgesics are among the top three drugs in which medication-related adverse events are reported to The Joint Commission,” Zhani says. “They also rank among the drugs most frequently associated with adverse drug events.”

Opioids are associated with numerous problems—underprescribing, overprescribing, tolerance, dependence, and drug abuse. To prevent accidental overuse, The Joint Commission recommends that healthcare organizations provide ongoing oversight of patients receiving these drugs. Pain-management specialists or pharmacists should review treatment plans and also track incidents involving opioids.

Harnessing available technology also helps improve prescribing safety. In addition to creating alerts for dosing limits, The Joint Commission suggests using “tall man” lettering in electronic ordering systems, conversion support to calculate correct dosages, and patient-controlled analgesia. Education and training in the safe use of opioids should be provided for clinicians, staff, and patients. And standardized tools should be employed to screen patients for risk factors, such as oversedation and respiratory depression.

Dr. Liao

“Opioids aren’t dangerous in themselves,” says Solomon Liao, MD, FAAHPM, a hospitalist and director of palliative-care services at the University of California at Irvine. “Opioids are dangerous when prescribers don’t know what they’re doing. It’s like the old saying, ‘Guns don’t kill people; people kill people.’”

Overdose deaths from opioid pain relievers have escalated, nearly quadrupling from 1999 to 2008. These deaths now exceed fatalities due to heroin and cocaine combined. In 2008, drug overdoses in the United States caused 36,450 deaths; opioid analgesics were involved in 14,800 (73.8%) of 20,044 prescription drug overdose deaths, according to the Centers for Disease Control and Prevention.1

Vital statistics data suggest that methadone is involved in one-third of opioid pain-reliever-related overdose deaths, even though it accounts for only a small percentage of prescriptions for opioid analgesics. The rate of methadone overdose deaths in the U.S. in 2009 was 5.5 times the rate in 1999, prompting an urgent call for interventions to address misuse and abuse.2

“The greatest safety concern The Joint Commission’s report cites is that sedation precedes respiratory depression in many cases, and clinicians need to pay more attention to that side effect and patients who are inherently at risk for developing respiratory problems related to opioids,” says Paul Arnstein, RN, PhD, FAAN, Connell Nursing Research Scholar and clinical nurse specialist for pain relief at Massachusetts General Hospital in Boston.

 

 

A Double-Edged Sword

Opioids deliver good pain control with minimal adverse effects for some patients but not for others, and there is insufficient evidence to foresee who will fare well and who won’t. “What we can predict,” Arnstein says, “is that certain patients—the very old, very young, very ill, and those receiving medicines that interact with opioids—are vulnerable to some of the more dangerous effects.”

The risk of respiratory depression also mounts in those who are opioid-naïve, as well as in an increasingly obese population.

“This does not mean we withhold pain relief,” says Judith A. Paice, PhD, RN, a contributor to The Joint Commission’s alert and director of the cancer pain program in the hematology-oncology division at Northwestern University’s Feinberg School of Medicine. Instead, “we need to determine the most effective monitoring techniques in a setting where hospitals are cutting back on staffing,” she adds.

Other risk factors for respiratory depression include sleep apnea (correlated with obesity but also possible in the absence of excess weight), large thoracic or abdominal incisions, and use of other sedating drugs. Among patients in the chronic cancer pain or palliative-care setting, respiratory depression is highly unusual because dosages are increased gradually, Paice says. Strong consensus supports prescribing opioids for acute episodes of pain, as well as chronic management of cancer and other life-threatening illnesses, including HIV/AIDS and cardiac and neuromuscular conditions.

Considerable variations exist in screening for risk of opioid-induced sedation and hospital monitoring practices. There is also a shortage of information and no consensus on the advantages of costly technology-supported monitoring, such as pulse oximetry (measuring oxygen saturation) and capnography (measuring end-tidal carbon dioxide), in hospitalized patients receiving opioids for pain therapy, according to guidelines from the American Society for Pain Management Nursing.3

 Jarzyna

Although technological monitoring adds valuable data to patient status, it does not replace frequent assessments—the most important intervention in detecting sedation before respiratory depression. Technological monitoring should be considered for patients at high risk for decline, says the guidelines’ lead author, Donna Jarzyna, MS, RN-BC, CNS-BC, an adult health clinical nurse specialist consulting in an alumna role for the University of Arizona Medical Center in Tucson. “Many organizations are currently making an effort,” she says, “to determine which patients should be monitored with a higher degree of intensity and with greater frequency.”

Patient-controlled analgesia (PCA) also has some limitations. In theory, it offers built-in safety features—if patients become too sedated, they can’t push a button for extra doses—but that isn’t always the case. For instance, some patients may have “stacked” three to four doses before sedation and respiratory depression develop. “When things go wrong with PCA, patients are four times more likely to be seriously harmed than when nurses administer the medications,” says Arnstein, who is a past president of the American Society for Pain Management Nursing. “Thus, vigilant nurse-supervised opioid therapy is vitally important.”

What we can predict is that certain patients—the very old, very young, very ill, and those receiving medicines that interact with opioids—are vulnerable to some of the more dangerous effects of the drug.

—Paul Arnstein, RN, PhD, FAAN, Connell Nursing Research Scholar, clinical nurse specialist for pain relief, Massachusetts General Hospital, Boston

Simple Steps Save Lives

Most critical events associated with opioids occur during the first 24 hours of post-operative care. Combined with close monitoring, understanding the risk factors for respiratory depression and making adjustments based on an individual’s needs and response helps prevent a precarious situation in which a patient vacillates quickly from a wide-awake status to a sleepy state.

 

 

“There’s a very progressive amount of sedation,” says Deb Gordon, RN, DNP, FAAN, a contributor to The Joint Commission’s alert and a teaching associate in the department of anesthesiology and pain medicine at the University of Washington in Seattle.

Dr. Gordon

Developing a pain treatment plan with a reassessment component is essential to exercising caution against potential harm from opioids.

“The Joint Commission’s guidance is wonderfully helpful and will benefit patients,” says Beth B. Murinson, MS, MD, PhD, associate professor and director of pain education in the department of neurology at Johns Hopkins University School of Medicine in Baltimore. “Getting opioid pain relief right is critically important as lives are hanging in the balance on both sides of this problem: Too little pain relief and millions will suffer; too much and lives are at risk.”

Hospitalists should be familiar with a few opioids that they feel comfortable prescribing, Dr. Murinson says. Be prepared to easily identify the major idiosyncratic effects and ordinary side effects of these medications and become well versed in opioid conversion.

“This is a classic problem in the field because, although the opioids are generally similar in their efficacy against pain, they have markedly different potencies against pain,” she explains. “A dose of 2 mg of morphine may need to be ‘converted’ to X mg of another opioid, depending on local practice patterns and preferences.”

Some drugs pose special risks. For example, transdermal fentanyl is “appropriate only for use in people who need opioid-level analgesia for an extended period of time and whose analgesic requirements are stable. This is not the case for folks with acute pain or who are just starting on opioids,” cautions Scott Strassels, PhD, PharmD, BCPS, assistant professor in the College of Pharmacy at the University of Texas in Austin and a board member of the American Pain Society. “Similarly, methadone is a good analgesic, but it requires very careful use due to its pharmacokinetic profile.”

Healthcare professionals from a variety of disciplines should be involved in pain-management efforts within a hospital setting. As for who takes the initiative, “it probably should be the person who is most qualified—be it a physician, nurse, or pharmacist,” Strassels says. “I’ve seen pharmacist-led teams, nurse-led teams, and those with physicians leading the effort.”

Clinicians who prescribe pain medications should be cognizant of nonpharmacologic alternatives to opioids. Multimodal options include physical therapy, acupuncture, manipulation or massage, and non-narcotic analgesics, such as acetaminophen and muscle relaxants. Non-narcotics may lower the dose of opioids needed to effectively manage pain, according to The Joint Commission.

The alert also provides information on suggested actions to avoid unintended consequences of using opioids. Hospitals should fully inform and provide written instructions to the patient and family or caregiver about the potential risks of tolerance, addiction, physical dependency, and withdrawal from opioids. When providing this information at discharge, the hospital also should list phone numbers to call if there are any questions.

In some unfortunate cases, opioids prescribed for pain also are used by patients’ family members, friends, and others. In such instances, says Northwestern’s Paice, usage occurs commonly with polypharmacy and without monitoring, and this contributes to an increased risk of death associated with opioids.

“There is concern that drugs prescribed for legitimate purposes are reaching the wrong hands,” Paice says. “We need to make the public, particularly patients and their family members, aware of safety strategies.”


Susan Kreimer is a freelance writer in New York City.

More Info for Hospitalists

Educational Options in Pain Medicine

  • The American Academy of Pain Medicine (www.painmed.org/store) offers a selection of pain education modules for a fee that can be studied for continuing medical education (CME) credits.
  • The American Pain Society (www.ampainsoc.org/education) provides reference materials (CME is not currently available) that are relevant to hospitalists seeking to incorporate strategies into practice.
  • The FDA’s “Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics” helps clinicians balance the benefits of treating pain against the risks of serious adverse outcomes. Visit www.fda.gov and search “drug safety.”
  • The American Medical Association is in the process of re-releasing materials on pain education. The materials have undergone expert review and are geared toward the CME accreditation process. Visit www.ama-assn.org and click on the CME microsite.

—Susan Kreimer

 

 

References

  1. Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60(43):1487-1492.
  2. Centers for Disease Control and Prevention. Vital signs: risk for overdose from methadone used for pain relief—United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2012;61(26):493-497.
  3. Jarzyna D, Jungquist CR, Pasero C, et al. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011;12(3):118-145.
Issue
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Opioid overuse can spell the onset of onerous consequences. The analgesics can slow breathing to dangerous levels and lead to dizziness, nausea, and falls.

Citing these concerns, The Joint Commission issued a Sentinel Event Alert in August 2012 that urged hospitals to take specific measures to help avoid serious complications and even deaths from the use of such opioids as morphine, oxycodone, and methadone.

“The Joint Commission recognizes that there is an opportunity to improve the care of patients on opioids in acute-care settings,” spokeswoman Elizabeth Eaken Zhani says. “Healthcare workers need to be aware of the risks to patients in prescribing opioids.”

Adverse events involving opioids include dosing errors and improper monitoring of patients and drug interactions. Patients who have sleep apnea, are obese, or very ill—with such conditions as pulmonary disease, congestive heart failure, or impaired renal function—might be at higher risk for harm from opioids.

Getting opioid pain relief right is critically important, as lives are hanging in the balance on both sides of this problem: Too little pain relief and millions will suffer; too much and lives are at risk.

—Beth B. Murinson, MS, MD, PhD, associate professor, director of pain education, department of neurology, The Johns University Hopkins School of Medicine, Baltimore

“The alert was issued in response to concerns that opioid analgesics are among the top three drugs in which medication-related adverse events are reported to The Joint Commission,” Zhani says. “They also rank among the drugs most frequently associated with adverse drug events.”

Opioids are associated with numerous problems—underprescribing, overprescribing, tolerance, dependence, and drug abuse. To prevent accidental overuse, The Joint Commission recommends that healthcare organizations provide ongoing oversight of patients receiving these drugs. Pain-management specialists or pharmacists should review treatment plans and also track incidents involving opioids.

Harnessing available technology also helps improve prescribing safety. In addition to creating alerts for dosing limits, The Joint Commission suggests using “tall man” lettering in electronic ordering systems, conversion support to calculate correct dosages, and patient-controlled analgesia. Education and training in the safe use of opioids should be provided for clinicians, staff, and patients. And standardized tools should be employed to screen patients for risk factors, such as oversedation and respiratory depression.

Dr. Liao

“Opioids aren’t dangerous in themselves,” says Solomon Liao, MD, FAAHPM, a hospitalist and director of palliative-care services at the University of California at Irvine. “Opioids are dangerous when prescribers don’t know what they’re doing. It’s like the old saying, ‘Guns don’t kill people; people kill people.’”

Overdose deaths from opioid pain relievers have escalated, nearly quadrupling from 1999 to 2008. These deaths now exceed fatalities due to heroin and cocaine combined. In 2008, drug overdoses in the United States caused 36,450 deaths; opioid analgesics were involved in 14,800 (73.8%) of 20,044 prescription drug overdose deaths, according to the Centers for Disease Control and Prevention.1

Vital statistics data suggest that methadone is involved in one-third of opioid pain-reliever-related overdose deaths, even though it accounts for only a small percentage of prescriptions for opioid analgesics. The rate of methadone overdose deaths in the U.S. in 2009 was 5.5 times the rate in 1999, prompting an urgent call for interventions to address misuse and abuse.2

“The greatest safety concern The Joint Commission’s report cites is that sedation precedes respiratory depression in many cases, and clinicians need to pay more attention to that side effect and patients who are inherently at risk for developing respiratory problems related to opioids,” says Paul Arnstein, RN, PhD, FAAN, Connell Nursing Research Scholar and clinical nurse specialist for pain relief at Massachusetts General Hospital in Boston.

 

 

A Double-Edged Sword

Opioids deliver good pain control with minimal adverse effects for some patients but not for others, and there is insufficient evidence to foresee who will fare well and who won’t. “What we can predict,” Arnstein says, “is that certain patients—the very old, very young, very ill, and those receiving medicines that interact with opioids—are vulnerable to some of the more dangerous effects.”

The risk of respiratory depression also mounts in those who are opioid-naïve, as well as in an increasingly obese population.

“This does not mean we withhold pain relief,” says Judith A. Paice, PhD, RN, a contributor to The Joint Commission’s alert and director of the cancer pain program in the hematology-oncology division at Northwestern University’s Feinberg School of Medicine. Instead, “we need to determine the most effective monitoring techniques in a setting where hospitals are cutting back on staffing,” she adds.

Other risk factors for respiratory depression include sleep apnea (correlated with obesity but also possible in the absence of excess weight), large thoracic or abdominal incisions, and use of other sedating drugs. Among patients in the chronic cancer pain or palliative-care setting, respiratory depression is highly unusual because dosages are increased gradually, Paice says. Strong consensus supports prescribing opioids for acute episodes of pain, as well as chronic management of cancer and other life-threatening illnesses, including HIV/AIDS and cardiac and neuromuscular conditions.

Considerable variations exist in screening for risk of opioid-induced sedation and hospital monitoring practices. There is also a shortage of information and no consensus on the advantages of costly technology-supported monitoring, such as pulse oximetry (measuring oxygen saturation) and capnography (measuring end-tidal carbon dioxide), in hospitalized patients receiving opioids for pain therapy, according to guidelines from the American Society for Pain Management Nursing.3

 Jarzyna

Although technological monitoring adds valuable data to patient status, it does not replace frequent assessments—the most important intervention in detecting sedation before respiratory depression. Technological monitoring should be considered for patients at high risk for decline, says the guidelines’ lead author, Donna Jarzyna, MS, RN-BC, CNS-BC, an adult health clinical nurse specialist consulting in an alumna role for the University of Arizona Medical Center in Tucson. “Many organizations are currently making an effort,” she says, “to determine which patients should be monitored with a higher degree of intensity and with greater frequency.”

Patient-controlled analgesia (PCA) also has some limitations. In theory, it offers built-in safety features—if patients become too sedated, they can’t push a button for extra doses—but that isn’t always the case. For instance, some patients may have “stacked” three to four doses before sedation and respiratory depression develop. “When things go wrong with PCA, patients are four times more likely to be seriously harmed than when nurses administer the medications,” says Arnstein, who is a past president of the American Society for Pain Management Nursing. “Thus, vigilant nurse-supervised opioid therapy is vitally important.”

What we can predict is that certain patients—the very old, very young, very ill, and those receiving medicines that interact with opioids—are vulnerable to some of the more dangerous effects of the drug.

—Paul Arnstein, RN, PhD, FAAN, Connell Nursing Research Scholar, clinical nurse specialist for pain relief, Massachusetts General Hospital, Boston

Simple Steps Save Lives

Most critical events associated with opioids occur during the first 24 hours of post-operative care. Combined with close monitoring, understanding the risk factors for respiratory depression and making adjustments based on an individual’s needs and response helps prevent a precarious situation in which a patient vacillates quickly from a wide-awake status to a sleepy state.

 

 

“There’s a very progressive amount of sedation,” says Deb Gordon, RN, DNP, FAAN, a contributor to The Joint Commission’s alert and a teaching associate in the department of anesthesiology and pain medicine at the University of Washington in Seattle.

Dr. Gordon

Developing a pain treatment plan with a reassessment component is essential to exercising caution against potential harm from opioids.

“The Joint Commission’s guidance is wonderfully helpful and will benefit patients,” says Beth B. Murinson, MS, MD, PhD, associate professor and director of pain education in the department of neurology at Johns Hopkins University School of Medicine in Baltimore. “Getting opioid pain relief right is critically important as lives are hanging in the balance on both sides of this problem: Too little pain relief and millions will suffer; too much and lives are at risk.”

Hospitalists should be familiar with a few opioids that they feel comfortable prescribing, Dr. Murinson says. Be prepared to easily identify the major idiosyncratic effects and ordinary side effects of these medications and become well versed in opioid conversion.

“This is a classic problem in the field because, although the opioids are generally similar in their efficacy against pain, they have markedly different potencies against pain,” she explains. “A dose of 2 mg of morphine may need to be ‘converted’ to X mg of another opioid, depending on local practice patterns and preferences.”

Some drugs pose special risks. For example, transdermal fentanyl is “appropriate only for use in people who need opioid-level analgesia for an extended period of time and whose analgesic requirements are stable. This is not the case for folks with acute pain or who are just starting on opioids,” cautions Scott Strassels, PhD, PharmD, BCPS, assistant professor in the College of Pharmacy at the University of Texas in Austin and a board member of the American Pain Society. “Similarly, methadone is a good analgesic, but it requires very careful use due to its pharmacokinetic profile.”

Healthcare professionals from a variety of disciplines should be involved in pain-management efforts within a hospital setting. As for who takes the initiative, “it probably should be the person who is most qualified—be it a physician, nurse, or pharmacist,” Strassels says. “I’ve seen pharmacist-led teams, nurse-led teams, and those with physicians leading the effort.”

Clinicians who prescribe pain medications should be cognizant of nonpharmacologic alternatives to opioids. Multimodal options include physical therapy, acupuncture, manipulation or massage, and non-narcotic analgesics, such as acetaminophen and muscle relaxants. Non-narcotics may lower the dose of opioids needed to effectively manage pain, according to The Joint Commission.

The alert also provides information on suggested actions to avoid unintended consequences of using opioids. Hospitals should fully inform and provide written instructions to the patient and family or caregiver about the potential risks of tolerance, addiction, physical dependency, and withdrawal from opioids. When providing this information at discharge, the hospital also should list phone numbers to call if there are any questions.

In some unfortunate cases, opioids prescribed for pain also are used by patients’ family members, friends, and others. In such instances, says Northwestern’s Paice, usage occurs commonly with polypharmacy and without monitoring, and this contributes to an increased risk of death associated with opioids.

“There is concern that drugs prescribed for legitimate purposes are reaching the wrong hands,” Paice says. “We need to make the public, particularly patients and their family members, aware of safety strategies.”


Susan Kreimer is a freelance writer in New York City.

More Info for Hospitalists

Educational Options in Pain Medicine

  • The American Academy of Pain Medicine (www.painmed.org/store) offers a selection of pain education modules for a fee that can be studied for continuing medical education (CME) credits.
  • The American Pain Society (www.ampainsoc.org/education) provides reference materials (CME is not currently available) that are relevant to hospitalists seeking to incorporate strategies into practice.
  • The FDA’s “Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics” helps clinicians balance the benefits of treating pain against the risks of serious adverse outcomes. Visit www.fda.gov and search “drug safety.”
  • The American Medical Association is in the process of re-releasing materials on pain education. The materials have undergone expert review and are geared toward the CME accreditation process. Visit www.ama-assn.org and click on the CME microsite.

—Susan Kreimer

 

 

References

  1. Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60(43):1487-1492.
  2. Centers for Disease Control and Prevention. Vital signs: risk for overdose from methadone used for pain relief—United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2012;61(26):493-497.
  3. Jarzyna D, Jungquist CR, Pasero C, et al. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011;12(3):118-145.

Opioid overuse can spell the onset of onerous consequences. The analgesics can slow breathing to dangerous levels and lead to dizziness, nausea, and falls.

Citing these concerns, The Joint Commission issued a Sentinel Event Alert in August 2012 that urged hospitals to take specific measures to help avoid serious complications and even deaths from the use of such opioids as morphine, oxycodone, and methadone.

“The Joint Commission recognizes that there is an opportunity to improve the care of patients on opioids in acute-care settings,” spokeswoman Elizabeth Eaken Zhani says. “Healthcare workers need to be aware of the risks to patients in prescribing opioids.”

Adverse events involving opioids include dosing errors and improper monitoring of patients and drug interactions. Patients who have sleep apnea, are obese, or very ill—with such conditions as pulmonary disease, congestive heart failure, or impaired renal function—might be at higher risk for harm from opioids.

Getting opioid pain relief right is critically important, as lives are hanging in the balance on both sides of this problem: Too little pain relief and millions will suffer; too much and lives are at risk.

—Beth B. Murinson, MS, MD, PhD, associate professor, director of pain education, department of neurology, The Johns University Hopkins School of Medicine, Baltimore

“The alert was issued in response to concerns that opioid analgesics are among the top three drugs in which medication-related adverse events are reported to The Joint Commission,” Zhani says. “They also rank among the drugs most frequently associated with adverse drug events.”

Opioids are associated with numerous problems—underprescribing, overprescribing, tolerance, dependence, and drug abuse. To prevent accidental overuse, The Joint Commission recommends that healthcare organizations provide ongoing oversight of patients receiving these drugs. Pain-management specialists or pharmacists should review treatment plans and also track incidents involving opioids.

Harnessing available technology also helps improve prescribing safety. In addition to creating alerts for dosing limits, The Joint Commission suggests using “tall man” lettering in electronic ordering systems, conversion support to calculate correct dosages, and patient-controlled analgesia. Education and training in the safe use of opioids should be provided for clinicians, staff, and patients. And standardized tools should be employed to screen patients for risk factors, such as oversedation and respiratory depression.

Dr. Liao

“Opioids aren’t dangerous in themselves,” says Solomon Liao, MD, FAAHPM, a hospitalist and director of palliative-care services at the University of California at Irvine. “Opioids are dangerous when prescribers don’t know what they’re doing. It’s like the old saying, ‘Guns don’t kill people; people kill people.’”

Overdose deaths from opioid pain relievers have escalated, nearly quadrupling from 1999 to 2008. These deaths now exceed fatalities due to heroin and cocaine combined. In 2008, drug overdoses in the United States caused 36,450 deaths; opioid analgesics were involved in 14,800 (73.8%) of 20,044 prescription drug overdose deaths, according to the Centers for Disease Control and Prevention.1

Vital statistics data suggest that methadone is involved in one-third of opioid pain-reliever-related overdose deaths, even though it accounts for only a small percentage of prescriptions for opioid analgesics. The rate of methadone overdose deaths in the U.S. in 2009 was 5.5 times the rate in 1999, prompting an urgent call for interventions to address misuse and abuse.2

“The greatest safety concern The Joint Commission’s report cites is that sedation precedes respiratory depression in many cases, and clinicians need to pay more attention to that side effect and patients who are inherently at risk for developing respiratory problems related to opioids,” says Paul Arnstein, RN, PhD, FAAN, Connell Nursing Research Scholar and clinical nurse specialist for pain relief at Massachusetts General Hospital in Boston.

 

 

A Double-Edged Sword

Opioids deliver good pain control with minimal adverse effects for some patients but not for others, and there is insufficient evidence to foresee who will fare well and who won’t. “What we can predict,” Arnstein says, “is that certain patients—the very old, very young, very ill, and those receiving medicines that interact with opioids—are vulnerable to some of the more dangerous effects.”

The risk of respiratory depression also mounts in those who are opioid-naïve, as well as in an increasingly obese population.

“This does not mean we withhold pain relief,” says Judith A. Paice, PhD, RN, a contributor to The Joint Commission’s alert and director of the cancer pain program in the hematology-oncology division at Northwestern University’s Feinberg School of Medicine. Instead, “we need to determine the most effective monitoring techniques in a setting where hospitals are cutting back on staffing,” she adds.

Other risk factors for respiratory depression include sleep apnea (correlated with obesity but also possible in the absence of excess weight), large thoracic or abdominal incisions, and use of other sedating drugs. Among patients in the chronic cancer pain or palliative-care setting, respiratory depression is highly unusual because dosages are increased gradually, Paice says. Strong consensus supports prescribing opioids for acute episodes of pain, as well as chronic management of cancer and other life-threatening illnesses, including HIV/AIDS and cardiac and neuromuscular conditions.

Considerable variations exist in screening for risk of opioid-induced sedation and hospital monitoring practices. There is also a shortage of information and no consensus on the advantages of costly technology-supported monitoring, such as pulse oximetry (measuring oxygen saturation) and capnography (measuring end-tidal carbon dioxide), in hospitalized patients receiving opioids for pain therapy, according to guidelines from the American Society for Pain Management Nursing.3

 Jarzyna

Although technological monitoring adds valuable data to patient status, it does not replace frequent assessments—the most important intervention in detecting sedation before respiratory depression. Technological monitoring should be considered for patients at high risk for decline, says the guidelines’ lead author, Donna Jarzyna, MS, RN-BC, CNS-BC, an adult health clinical nurse specialist consulting in an alumna role for the University of Arizona Medical Center in Tucson. “Many organizations are currently making an effort,” she says, “to determine which patients should be monitored with a higher degree of intensity and with greater frequency.”

Patient-controlled analgesia (PCA) also has some limitations. In theory, it offers built-in safety features—if patients become too sedated, they can’t push a button for extra doses—but that isn’t always the case. For instance, some patients may have “stacked” three to four doses before sedation and respiratory depression develop. “When things go wrong with PCA, patients are four times more likely to be seriously harmed than when nurses administer the medications,” says Arnstein, who is a past president of the American Society for Pain Management Nursing. “Thus, vigilant nurse-supervised opioid therapy is vitally important.”

What we can predict is that certain patients—the very old, very young, very ill, and those receiving medicines that interact with opioids—are vulnerable to some of the more dangerous effects of the drug.

—Paul Arnstein, RN, PhD, FAAN, Connell Nursing Research Scholar, clinical nurse specialist for pain relief, Massachusetts General Hospital, Boston

Simple Steps Save Lives

Most critical events associated with opioids occur during the first 24 hours of post-operative care. Combined with close monitoring, understanding the risk factors for respiratory depression and making adjustments based on an individual’s needs and response helps prevent a precarious situation in which a patient vacillates quickly from a wide-awake status to a sleepy state.

 

 

“There’s a very progressive amount of sedation,” says Deb Gordon, RN, DNP, FAAN, a contributor to The Joint Commission’s alert and a teaching associate in the department of anesthesiology and pain medicine at the University of Washington in Seattle.

Dr. Gordon

Developing a pain treatment plan with a reassessment component is essential to exercising caution against potential harm from opioids.

“The Joint Commission’s guidance is wonderfully helpful and will benefit patients,” says Beth B. Murinson, MS, MD, PhD, associate professor and director of pain education in the department of neurology at Johns Hopkins University School of Medicine in Baltimore. “Getting opioid pain relief right is critically important as lives are hanging in the balance on both sides of this problem: Too little pain relief and millions will suffer; too much and lives are at risk.”

Hospitalists should be familiar with a few opioids that they feel comfortable prescribing, Dr. Murinson says. Be prepared to easily identify the major idiosyncratic effects and ordinary side effects of these medications and become well versed in opioid conversion.

“This is a classic problem in the field because, although the opioids are generally similar in their efficacy against pain, they have markedly different potencies against pain,” she explains. “A dose of 2 mg of morphine may need to be ‘converted’ to X mg of another opioid, depending on local practice patterns and preferences.”

Some drugs pose special risks. For example, transdermal fentanyl is “appropriate only for use in people who need opioid-level analgesia for an extended period of time and whose analgesic requirements are stable. This is not the case for folks with acute pain or who are just starting on opioids,” cautions Scott Strassels, PhD, PharmD, BCPS, assistant professor in the College of Pharmacy at the University of Texas in Austin and a board member of the American Pain Society. “Similarly, methadone is a good analgesic, but it requires very careful use due to its pharmacokinetic profile.”

Healthcare professionals from a variety of disciplines should be involved in pain-management efforts within a hospital setting. As for who takes the initiative, “it probably should be the person who is most qualified—be it a physician, nurse, or pharmacist,” Strassels says. “I’ve seen pharmacist-led teams, nurse-led teams, and those with physicians leading the effort.”

Clinicians who prescribe pain medications should be cognizant of nonpharmacologic alternatives to opioids. Multimodal options include physical therapy, acupuncture, manipulation or massage, and non-narcotic analgesics, such as acetaminophen and muscle relaxants. Non-narcotics may lower the dose of opioids needed to effectively manage pain, according to The Joint Commission.

The alert also provides information on suggested actions to avoid unintended consequences of using opioids. Hospitals should fully inform and provide written instructions to the patient and family or caregiver about the potential risks of tolerance, addiction, physical dependency, and withdrawal from opioids. When providing this information at discharge, the hospital also should list phone numbers to call if there are any questions.

In some unfortunate cases, opioids prescribed for pain also are used by patients’ family members, friends, and others. In such instances, says Northwestern’s Paice, usage occurs commonly with polypharmacy and without monitoring, and this contributes to an increased risk of death associated with opioids.

“There is concern that drugs prescribed for legitimate purposes are reaching the wrong hands,” Paice says. “We need to make the public, particularly patients and their family members, aware of safety strategies.”


Susan Kreimer is a freelance writer in New York City.

More Info for Hospitalists

Educational Options in Pain Medicine

  • The American Academy of Pain Medicine (www.painmed.org/store) offers a selection of pain education modules for a fee that can be studied for continuing medical education (CME) credits.
  • The American Pain Society (www.ampainsoc.org/education) provides reference materials (CME is not currently available) that are relevant to hospitalists seeking to incorporate strategies into practice.
  • The FDA’s “Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics” helps clinicians balance the benefits of treating pain against the risks of serious adverse outcomes. Visit www.fda.gov and search “drug safety.”
  • The American Medical Association is in the process of re-releasing materials on pain education. The materials have undergone expert review and are geared toward the CME accreditation process. Visit www.ama-assn.org and click on the CME microsite.

—Susan Kreimer

 

 

References

  1. Centers for Disease Control and Prevention. Vital signs: overdoses of prescription opioid pain relievers—United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60(43):1487-1492.
  2. Centers for Disease Control and Prevention. Vital signs: risk for overdose from methadone used for pain relief—United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2012;61(26):493-497.
  3. Jarzyna D, Jungquist CR, Pasero C, et al. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011;12(3):118-145.
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Serious Complications from Opioid Overuse in Hospitalized Patients Prompts Nationwide Alert
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Patient Understanding of ED Discharge Instructions Is Poor

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Patient Understanding of ED Discharge Instructions Is Poor

Clinical question: How well do patients understand discharge instructions regarding post-ED care?

Background: Studies have demonstrated that patients discharged from the ED often lack appropriate understanding of their care. Knowledge deficits are particularly common in the area of post-ED care; however, it is not clear in which aspects of post-ED care these knowledge deficits are most pronounced.

Study design: Prospective cohort study.

Setting: Single-center academic urban hospital.

Synopsis: The researchers in this study discharged patients from the ED with five common diagnoses: ankle sprain, back pain, head injury, kidney stone, and laceration. Interviewers used formalized questioning to assess patient comprehension in five specific areas of post-ED care: diagnosis, medication, follow-up care, home care, and return instructions. Rates of severe knowledge deficits were most pronounced in the domains of home care (40.1%) and return instructions (50.7%). Rates of severe knowledge deficits in the domains of diagnosis, medication, and follow-up care were 3.2%, 3.2%, and 18.4%, respectively.

Though performed in the ED, the results of this study could inform the approach to inpatient discharges. However, the exclusion of patients with psychiatric disease, cognitive impairment, and multiple diagnoses suggests that the results might be even worse in a complicated inpatient cohort. The study also indicates that discharge instructions for home care and return precautions merit closer attention.

Bottom line: Patients discharged from the ED demonstrate poor comprehension of discharge instructions regarding post-ED care.

Citation: Engel KG, Buckley BA, Forth VE, et al. Patient understanding of emergency department discharge instructions: where are knowledge deficits greatest? Acad Emerg Med. 2012;19:1035-1044.

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Clinical question: How well do patients understand discharge instructions regarding post-ED care?

Background: Studies have demonstrated that patients discharged from the ED often lack appropriate understanding of their care. Knowledge deficits are particularly common in the area of post-ED care; however, it is not clear in which aspects of post-ED care these knowledge deficits are most pronounced.

Study design: Prospective cohort study.

Setting: Single-center academic urban hospital.

Synopsis: The researchers in this study discharged patients from the ED with five common diagnoses: ankle sprain, back pain, head injury, kidney stone, and laceration. Interviewers used formalized questioning to assess patient comprehension in five specific areas of post-ED care: diagnosis, medication, follow-up care, home care, and return instructions. Rates of severe knowledge deficits were most pronounced in the domains of home care (40.1%) and return instructions (50.7%). Rates of severe knowledge deficits in the domains of diagnosis, medication, and follow-up care were 3.2%, 3.2%, and 18.4%, respectively.

Though performed in the ED, the results of this study could inform the approach to inpatient discharges. However, the exclusion of patients with psychiatric disease, cognitive impairment, and multiple diagnoses suggests that the results might be even worse in a complicated inpatient cohort. The study also indicates that discharge instructions for home care and return precautions merit closer attention.

Bottom line: Patients discharged from the ED demonstrate poor comprehension of discharge instructions regarding post-ED care.

Citation: Engel KG, Buckley BA, Forth VE, et al. Patient understanding of emergency department discharge instructions: where are knowledge deficits greatest? Acad Emerg Med. 2012;19:1035-1044.

Clinical question: How well do patients understand discharge instructions regarding post-ED care?

Background: Studies have demonstrated that patients discharged from the ED often lack appropriate understanding of their care. Knowledge deficits are particularly common in the area of post-ED care; however, it is not clear in which aspects of post-ED care these knowledge deficits are most pronounced.

Study design: Prospective cohort study.

Setting: Single-center academic urban hospital.

Synopsis: The researchers in this study discharged patients from the ED with five common diagnoses: ankle sprain, back pain, head injury, kidney stone, and laceration. Interviewers used formalized questioning to assess patient comprehension in five specific areas of post-ED care: diagnosis, medication, follow-up care, home care, and return instructions. Rates of severe knowledge deficits were most pronounced in the domains of home care (40.1%) and return instructions (50.7%). Rates of severe knowledge deficits in the domains of diagnosis, medication, and follow-up care were 3.2%, 3.2%, and 18.4%, respectively.

Though performed in the ED, the results of this study could inform the approach to inpatient discharges. However, the exclusion of patients with psychiatric disease, cognitive impairment, and multiple diagnoses suggests that the results might be even worse in a complicated inpatient cohort. The study also indicates that discharge instructions for home care and return precautions merit closer attention.

Bottom line: Patients discharged from the ED demonstrate poor comprehension of discharge instructions regarding post-ED care.

Citation: Engel KG, Buckley BA, Forth VE, et al. Patient understanding of emergency department discharge instructions: where are knowledge deficits greatest? Acad Emerg Med. 2012;19:1035-1044.

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ACEIs and ARBs Associated with Contrast-Induced AKI

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ACEIs and ARBs Associated with Contrast-Induced AKI

Clinical question: Does the pharmacologic renin-angiotensin-aldosterone (RAAS) system blockade increase the risk for contrast-induced acute kidney injury (CI-AKI) after cardiac catheterization?

Background: Prior prospective studies have demonstrated conflicting results regarding the deleterious versus protective effects of RAAS blockade prior to cardiac catheterization.

Study design: Retrospective, propensity-score-matched cohort study.

Setting: Single-center teaching hospital in South Korea.

Synopsis: Researchers identified patients who had cardiac catheterization and applied propensity-score matching to generate cohorts of periprocedural angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) users versus non-users. CI-AKI occurred more frequently in patients treated with ACEIs/ARBs compared to those who were not (11.4% vs. 6.3%, respectively; P<0.001).

This study was limited by its observational design. Although the propensity-score matching improves the internal validity, it is possible that unaccounted confounders were present. This trial might stimulate interest in re-examining this issue in larger prospective trials, but it should not alter current practice.

Bottom line: RAAS blockade during cardiac catheterization is associated with increased risk for CI-AKI, but further randomized trials are needed to confirm this conclusion.

Citation: Rim MY, Ro H, Kang WC, et al. The effect of renin-angiotensin-aldosterone system blockade on contrast-induced acute kidney injury: a propensity-matched study. Am J Kidney Dis. 2012;60:576-582.

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Clinical question: Does the pharmacologic renin-angiotensin-aldosterone (RAAS) system blockade increase the risk for contrast-induced acute kidney injury (CI-AKI) after cardiac catheterization?

Background: Prior prospective studies have demonstrated conflicting results regarding the deleterious versus protective effects of RAAS blockade prior to cardiac catheterization.

Study design: Retrospective, propensity-score-matched cohort study.

Setting: Single-center teaching hospital in South Korea.

Synopsis: Researchers identified patients who had cardiac catheterization and applied propensity-score matching to generate cohorts of periprocedural angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) users versus non-users. CI-AKI occurred more frequently in patients treated with ACEIs/ARBs compared to those who were not (11.4% vs. 6.3%, respectively; P<0.001).

This study was limited by its observational design. Although the propensity-score matching improves the internal validity, it is possible that unaccounted confounders were present. This trial might stimulate interest in re-examining this issue in larger prospective trials, but it should not alter current practice.

Bottom line: RAAS blockade during cardiac catheterization is associated with increased risk for CI-AKI, but further randomized trials are needed to confirm this conclusion.

Citation: Rim MY, Ro H, Kang WC, et al. The effect of renin-angiotensin-aldosterone system blockade on contrast-induced acute kidney injury: a propensity-matched study. Am J Kidney Dis. 2012;60:576-582.

Clinical question: Does the pharmacologic renin-angiotensin-aldosterone (RAAS) system blockade increase the risk for contrast-induced acute kidney injury (CI-AKI) after cardiac catheterization?

Background: Prior prospective studies have demonstrated conflicting results regarding the deleterious versus protective effects of RAAS blockade prior to cardiac catheterization.

Study design: Retrospective, propensity-score-matched cohort study.

Setting: Single-center teaching hospital in South Korea.

Synopsis: Researchers identified patients who had cardiac catheterization and applied propensity-score matching to generate cohorts of periprocedural angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB) users versus non-users. CI-AKI occurred more frequently in patients treated with ACEIs/ARBs compared to those who were not (11.4% vs. 6.3%, respectively; P<0.001).

This study was limited by its observational design. Although the propensity-score matching improves the internal validity, it is possible that unaccounted confounders were present. This trial might stimulate interest in re-examining this issue in larger prospective trials, but it should not alter current practice.

Bottom line: RAAS blockade during cardiac catheterization is associated with increased risk for CI-AKI, but further randomized trials are needed to confirm this conclusion.

Citation: Rim MY, Ro H, Kang WC, et al. The effect of renin-angiotensin-aldosterone system blockade on contrast-induced acute kidney injury: a propensity-matched study. Am J Kidney Dis. 2012;60:576-582.

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Effect of Nonpayment on Nosocomial Infection Rates in U.S. Hospitals

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Effect of Nonpayment on Nosocomial Infection Rates in U.S. Hospitals

Clinical question: Did the 2008 Center for Medicare & Medicaid Services (CMS) policy denying additional payment for hospital-acquired conditions result in decreased rates of nosocomial infections?

Background: In an effort to curtail preventable complications, CMS implemented a policy of nonpayment for certain healthcare-acquired conditions beginning in October 2008. The effect of this policy on rates of nosocomial infections, including central venous catheter-associated bloodstream infections and catheter-associated urinary tract infections, is unknown.

Study design: Quasi-experimental.

Setting: Data collected from 398 hospitals participating in the National Healthcare Safety Network of the Centers for Disease Control and Prevention.

Synopsis: Investigators analyzed rates of nosocomial infections in participating hospitals before and after implementation of the 2008 nonpayment policy. The rates of decline in central venous catheter infections were not significantly different in the pre-implementation and post-implementation periods (4.8% per quarter and 4.7% per quarter, respectively; incidence-rate ratio 1.0; P=0.97). Similar results were found with regard to catheter-associated UTIs before and after policy initiation (3.9% per quarter and 0.9% per quarter, incidence-rate ratio 1.03; P=0.08). Results did not vary between states with and without mandatory reporting of nosocomial infections.

While this study’s broad scope limits the ability to draw firm conclusions, it does highlight the need for careful evaluation and quantification of the outcomes resulting from CMS’ expansion of policies for financial incentives and disincentives.

Bottom line: National rates of decline in nosocomial infections were unchanged before and after implementation of CMS’ nonpayment policy in 2008.

Citation: Lee GM, Kleinman K, Soumerai SB, et al. Effect of nonpayment for preventable infections in U.S. hospitals. N Engl J Med. 2012;367:1428-1437

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Clinical question: Did the 2008 Center for Medicare & Medicaid Services (CMS) policy denying additional payment for hospital-acquired conditions result in decreased rates of nosocomial infections?

Background: In an effort to curtail preventable complications, CMS implemented a policy of nonpayment for certain healthcare-acquired conditions beginning in October 2008. The effect of this policy on rates of nosocomial infections, including central venous catheter-associated bloodstream infections and catheter-associated urinary tract infections, is unknown.

Study design: Quasi-experimental.

Setting: Data collected from 398 hospitals participating in the National Healthcare Safety Network of the Centers for Disease Control and Prevention.

Synopsis: Investigators analyzed rates of nosocomial infections in participating hospitals before and after implementation of the 2008 nonpayment policy. The rates of decline in central venous catheter infections were not significantly different in the pre-implementation and post-implementation periods (4.8% per quarter and 4.7% per quarter, respectively; incidence-rate ratio 1.0; P=0.97). Similar results were found with regard to catheter-associated UTIs before and after policy initiation (3.9% per quarter and 0.9% per quarter, incidence-rate ratio 1.03; P=0.08). Results did not vary between states with and without mandatory reporting of nosocomial infections.

While this study’s broad scope limits the ability to draw firm conclusions, it does highlight the need for careful evaluation and quantification of the outcomes resulting from CMS’ expansion of policies for financial incentives and disincentives.

Bottom line: National rates of decline in nosocomial infections were unchanged before and after implementation of CMS’ nonpayment policy in 2008.

Citation: Lee GM, Kleinman K, Soumerai SB, et al. Effect of nonpayment for preventable infections in U.S. hospitals. N Engl J Med. 2012;367:1428-1437

Clinical question: Did the 2008 Center for Medicare & Medicaid Services (CMS) policy denying additional payment for hospital-acquired conditions result in decreased rates of nosocomial infections?

Background: In an effort to curtail preventable complications, CMS implemented a policy of nonpayment for certain healthcare-acquired conditions beginning in October 2008. The effect of this policy on rates of nosocomial infections, including central venous catheter-associated bloodstream infections and catheter-associated urinary tract infections, is unknown.

Study design: Quasi-experimental.

Setting: Data collected from 398 hospitals participating in the National Healthcare Safety Network of the Centers for Disease Control and Prevention.

Synopsis: Investigators analyzed rates of nosocomial infections in participating hospitals before and after implementation of the 2008 nonpayment policy. The rates of decline in central venous catheter infections were not significantly different in the pre-implementation and post-implementation periods (4.8% per quarter and 4.7% per quarter, respectively; incidence-rate ratio 1.0; P=0.97). Similar results were found with regard to catheter-associated UTIs before and after policy initiation (3.9% per quarter and 0.9% per quarter, incidence-rate ratio 1.03; P=0.08). Results did not vary between states with and without mandatory reporting of nosocomial infections.

While this study’s broad scope limits the ability to draw firm conclusions, it does highlight the need for careful evaluation and quantification of the outcomes resulting from CMS’ expansion of policies for financial incentives and disincentives.

Bottom line: National rates of decline in nosocomial infections were unchanged before and after implementation of CMS’ nonpayment policy in 2008.

Citation: Lee GM, Kleinman K, Soumerai SB, et al. Effect of nonpayment for preventable infections in U.S. hospitals. N Engl J Med. 2012;367:1428-1437

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Radiofrequency Ablation and Antiarrythmics as First-Line Therapy in Atrial Fibrillation

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Radiofrequency Ablation and Antiarrythmics as First-Line Therapy in Atrial Fibrillation

Clinical question: How does radiofrequency ablation compare to antiarrhythmic therapy as first-line treatment for paroxysmal atrial fibrillation (AF)?

Background: Current American College of Cardiology/American Heart Association (ACC/AHA) guidelines support radiofrequency ablation in high-volume centers for select patients with symptomatic, paroxysmal AF who have failed antiarrhythmic therapy (Class I recommendation). Little data exist regarding catheter ablation as a first-line intervention.

Study design: Randomized prospective cohort study.

Setting: Multicenter Danish trial.

Synopsis: Investigators randomized patients with symptomatic paroxysmal AF who were deemed to be good candidates for rhythm control to antiarrhythmic therapy versus radiofrequency catheter ablation. Patients had seven-day Holter monitoring at three, six, 12, 18, and 24 months. There was no significant difference in the cumulative burden of AF between the antiarrhythmic and ablation groups (19% and 13%, respectively; P=0.10). Secondary outcomes including quality of life and cumulative burden of symptomatic AF did not vary significantly between the groups. Crossover was high, with 35% of patients randomized to antiarrhythmic therapy eventually undergoing catheter ablation during the trial. There was no statistically significant difference in adverse events between the two groups.

This trial lends credence to the current ACC/AHA guidelines recommending radiofrequency ablation as second-line therapy for patients with AF after failing antiarrhythmics.

Bottom line: Radiofrequency ablation and antiarrhythmic therapy have similar efficacy as first-line therapy in paroxysmal AF.

Citation: Nielsen JC, Johannessen A, Raatikainen P, et al. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med. 2012;367:1587-1595.

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Clinical question: How does radiofrequency ablation compare to antiarrhythmic therapy as first-line treatment for paroxysmal atrial fibrillation (AF)?

Background: Current American College of Cardiology/American Heart Association (ACC/AHA) guidelines support radiofrequency ablation in high-volume centers for select patients with symptomatic, paroxysmal AF who have failed antiarrhythmic therapy (Class I recommendation). Little data exist regarding catheter ablation as a first-line intervention.

Study design: Randomized prospective cohort study.

Setting: Multicenter Danish trial.

Synopsis: Investigators randomized patients with symptomatic paroxysmal AF who were deemed to be good candidates for rhythm control to antiarrhythmic therapy versus radiofrequency catheter ablation. Patients had seven-day Holter monitoring at three, six, 12, 18, and 24 months. There was no significant difference in the cumulative burden of AF between the antiarrhythmic and ablation groups (19% and 13%, respectively; P=0.10). Secondary outcomes including quality of life and cumulative burden of symptomatic AF did not vary significantly between the groups. Crossover was high, with 35% of patients randomized to antiarrhythmic therapy eventually undergoing catheter ablation during the trial. There was no statistically significant difference in adverse events between the two groups.

This trial lends credence to the current ACC/AHA guidelines recommending radiofrequency ablation as second-line therapy for patients with AF after failing antiarrhythmics.

Bottom line: Radiofrequency ablation and antiarrhythmic therapy have similar efficacy as first-line therapy in paroxysmal AF.

Citation: Nielsen JC, Johannessen A, Raatikainen P, et al. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med. 2012;367:1587-1595.

Clinical question: How does radiofrequency ablation compare to antiarrhythmic therapy as first-line treatment for paroxysmal atrial fibrillation (AF)?

Background: Current American College of Cardiology/American Heart Association (ACC/AHA) guidelines support radiofrequency ablation in high-volume centers for select patients with symptomatic, paroxysmal AF who have failed antiarrhythmic therapy (Class I recommendation). Little data exist regarding catheter ablation as a first-line intervention.

Study design: Randomized prospective cohort study.

Setting: Multicenter Danish trial.

Synopsis: Investigators randomized patients with symptomatic paroxysmal AF who were deemed to be good candidates for rhythm control to antiarrhythmic therapy versus radiofrequency catheter ablation. Patients had seven-day Holter monitoring at three, six, 12, 18, and 24 months. There was no significant difference in the cumulative burden of AF between the antiarrhythmic and ablation groups (19% and 13%, respectively; P=0.10). Secondary outcomes including quality of life and cumulative burden of symptomatic AF did not vary significantly between the groups. Crossover was high, with 35% of patients randomized to antiarrhythmic therapy eventually undergoing catheter ablation during the trial. There was no statistically significant difference in adverse events between the two groups.

This trial lends credence to the current ACC/AHA guidelines recommending radiofrequency ablation as second-line therapy for patients with AF after failing antiarrhythmics.

Bottom line: Radiofrequency ablation and antiarrhythmic therapy have similar efficacy as first-line therapy in paroxysmal AF.

Citation: Nielsen JC, Johannessen A, Raatikainen P, et al. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med. 2012;367:1587-1595.

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