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Dabigatran noninferior to warfarin for preventing recurrent VTE
Credit: Andre E.X. Brown
New research suggests dabigatran is noninferior to warfarin as extended prophylaxis for recurrent venous thromboembolism (VTE), and warfarin presents a significantly higher risk of bleeding.
These results are from the RE-MEDY study, which compared the 2 drugs as long-term prophylaxis in patients who had received at least 3 months of VTE treatment.
The data appear in an NEJM article alongside results of the RE-SONATE study, which compared dabigatran and placebo in a similar patient population.
Both of these randomized, double-blind studies were sponsored by the makers of dabigatran, Boehringer Ingelheim.
In the RE-MEDY trial, 2856 patients were randomized in a 1:1 ratio to receive dabigatran or warfarin for up to 36 months. Patients either received active dabigatran at 150 mg twice daily and a warfarin-like placebo or active warfarin and a dabigatran-like placebo. The warfarin dose was adjusted to maintain an INR of 2.0 to 3.0.
In the RE-SONATE trial, 1343 patients were randomized to receive treatment for 6 months. They were assigned in a 1:1 ratio to receive dabigatran at 150 mg twice daily or a matching placebo.
Extended follow-up to evaluate the long-term risk of VTE recurrence took place 12 months after the completion of study treatment.
In RE-MEDY, recurrent VTE occurred in 1.8% of patients in the dabigatran arm and 1.3% of patients in the warfarin arm (P=0.01 for noninferiority).
In RE-SONATE, recurrent VTE occurred in 0.4% of patients in the dabigatran arm and 5.6% of patients in the placebo arm (P<0.001 for superiority).
The rate of clinically relevant or major bleeding was lower with dabigatran than with warfarin—at 5.6% and 10.2%, respectively (P<0.001).
But the rate of clinically relevant or major bleeding was higher with dabigatran than with placebo, at 5.3% and 1.8%, respectively (P=0.001).
“[These results] suggest dabigatran is a good option to prevent deep vein thrombosis and pulmonary embolism from happening again after an initial event,” said lead study author Sam Schulman, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.
“They reinforce the efficacy and favorable safety profile of dabigatran seen in the RE-COVER trials, where dabigatran showed similar efficacy and a significant reduction in clinically relevant bleeding versus warfarin in the treatment of acute venous thromboembolism.” 
Credit: Andre E.X. Brown
New research suggests dabigatran is noninferior to warfarin as extended prophylaxis for recurrent venous thromboembolism (VTE), and warfarin presents a significantly higher risk of bleeding.
These results are from the RE-MEDY study, which compared the 2 drugs as long-term prophylaxis in patients who had received at least 3 months of VTE treatment.
The data appear in an NEJM article alongside results of the RE-SONATE study, which compared dabigatran and placebo in a similar patient population.
Both of these randomized, double-blind studies were sponsored by the makers of dabigatran, Boehringer Ingelheim.
In the RE-MEDY trial, 2856 patients were randomized in a 1:1 ratio to receive dabigatran or warfarin for up to 36 months. Patients either received active dabigatran at 150 mg twice daily and a warfarin-like placebo or active warfarin and a dabigatran-like placebo. The warfarin dose was adjusted to maintain an INR of 2.0 to 3.0.
In the RE-SONATE trial, 1343 patients were randomized to receive treatment for 6 months. They were assigned in a 1:1 ratio to receive dabigatran at 150 mg twice daily or a matching placebo.
Extended follow-up to evaluate the long-term risk of VTE recurrence took place 12 months after the completion of study treatment.
In RE-MEDY, recurrent VTE occurred in 1.8% of patients in the dabigatran arm and 1.3% of patients in the warfarin arm (P=0.01 for noninferiority).
In RE-SONATE, recurrent VTE occurred in 0.4% of patients in the dabigatran arm and 5.6% of patients in the placebo arm (P<0.001 for superiority).
The rate of clinically relevant or major bleeding was lower with dabigatran than with warfarin—at 5.6% and 10.2%, respectively (P<0.001).
But the rate of clinically relevant or major bleeding was higher with dabigatran than with placebo, at 5.3% and 1.8%, respectively (P=0.001).
“[These results] suggest dabigatran is a good option to prevent deep vein thrombosis and pulmonary embolism from happening again after an initial event,” said lead study author Sam Schulman, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.
“They reinforce the efficacy and favorable safety profile of dabigatran seen in the RE-COVER trials, where dabigatran showed similar efficacy and a significant reduction in clinically relevant bleeding versus warfarin in the treatment of acute venous thromboembolism.”
Credit: Andre E.X. Brown
New research suggests dabigatran is noninferior to warfarin as extended prophylaxis for recurrent venous thromboembolism (VTE), and warfarin presents a significantly higher risk of bleeding.
These results are from the RE-MEDY study, which compared the 2 drugs as long-term prophylaxis in patients who had received at least 3 months of VTE treatment.
The data appear in an NEJM article alongside results of the RE-SONATE study, which compared dabigatran and placebo in a similar patient population.
Both of these randomized, double-blind studies were sponsored by the makers of dabigatran, Boehringer Ingelheim.
In the RE-MEDY trial, 2856 patients were randomized in a 1:1 ratio to receive dabigatran or warfarin for up to 36 months. Patients either received active dabigatran at 150 mg twice daily and a warfarin-like placebo or active warfarin and a dabigatran-like placebo. The warfarin dose was adjusted to maintain an INR of 2.0 to 3.0.
In the RE-SONATE trial, 1343 patients were randomized to receive treatment for 6 months. They were assigned in a 1:1 ratio to receive dabigatran at 150 mg twice daily or a matching placebo.
Extended follow-up to evaluate the long-term risk of VTE recurrence took place 12 months after the completion of study treatment.
In RE-MEDY, recurrent VTE occurred in 1.8% of patients in the dabigatran arm and 1.3% of patients in the warfarin arm (P=0.01 for noninferiority).
In RE-SONATE, recurrent VTE occurred in 0.4% of patients in the dabigatran arm and 5.6% of patients in the placebo arm (P<0.001 for superiority).
The rate of clinically relevant or major bleeding was lower with dabigatran than with warfarin—at 5.6% and 10.2%, respectively (P<0.001).
But the rate of clinically relevant or major bleeding was higher with dabigatran than with placebo, at 5.3% and 1.8%, respectively (P=0.001).
“[These results] suggest dabigatran is a good option to prevent deep vein thrombosis and pulmonary embolism from happening again after an initial event,” said lead study author Sam Schulman, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.
“They reinforce the efficacy and favorable safety profile of dabigatran seen in the RE-COVER trials, where dabigatran showed similar efficacy and a significant reduction in clinically relevant bleeding versus warfarin in the treatment of acute venous thromboembolism.”
The Society of Hospital Medicine’s "Choosing Wisely" Recommendations for Hospitalists
SHM has joined the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely campaign, a multiyear effort to spark national dialogue about waste in the healthcare system and the kinds of common treatments that doctors and patients should think twice about before deciding to pursue. Ad hoc subcommittees of SHM’s Hospital Quality and Patient Safety Committee created lists of five adult and five pediatric treatments that hospitalists and their patients should question (see below). Those lists were shared alongside 15 other medical specialty societies at a Feb. 21 news conference in Washington, D.C.
Adult Hospitalist "Avoid List"
1. Do not place, or leave in place, urinary catheters for incontinence or convenience or monitoring of output for non-critically ill patients (acceptable indications: critical illness, obstruction, hospice, perioperatively for <2 days for urologic procedures; use weights instead to monitor diuresis).
2. Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless at high risk for GI complications.
3. Avoid transfusions of red blood cells for arbitrary hemoglobin or hematocrit thresholds and in the absence of symptoms or active coronary disease, heart failure or stroke.
4. Do not order continuous telemetry monitoring outside of the ICU without using a protocol that governs continuation.
5. Do not perform repetitive CBC and chemistry testing in the face of clinical and lab stability.
Pediatric HospitalIST "Avoid List"
1. Don’t order chest radiographs in children with uncomplicated asthma or bronchiolitis.
2. Don’t routinely use bronchodilators in children with bronchiolitis.
3. Don’t use systemic corticosteroids in children under 2 years of age with an uncomplicated lower respiratory tract infection.
4. Don’t treat gastroesophageal reflux in infants routinely with acid suppression therapy.
5. Don’t use continuous pulse oximetry routinely in children with acute respiratory illness unless they are on supplemental oxygen.
For complete recommendations and references, visit SHM's website.
SHM has joined the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely campaign, a multiyear effort to spark national dialogue about waste in the healthcare system and the kinds of common treatments that doctors and patients should think twice about before deciding to pursue. Ad hoc subcommittees of SHM’s Hospital Quality and Patient Safety Committee created lists of five adult and five pediatric treatments that hospitalists and their patients should question (see below). Those lists were shared alongside 15 other medical specialty societies at a Feb. 21 news conference in Washington, D.C.
Adult Hospitalist "Avoid List"
1. Do not place, or leave in place, urinary catheters for incontinence or convenience or monitoring of output for non-critically ill patients (acceptable indications: critical illness, obstruction, hospice, perioperatively for <2 days for urologic procedures; use weights instead to monitor diuresis).
2. Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless at high risk for GI complications.
3. Avoid transfusions of red blood cells for arbitrary hemoglobin or hematocrit thresholds and in the absence of symptoms or active coronary disease, heart failure or stroke.
4. Do not order continuous telemetry monitoring outside of the ICU without using a protocol that governs continuation.
5. Do not perform repetitive CBC and chemistry testing in the face of clinical and lab stability.
Pediatric HospitalIST "Avoid List"
1. Don’t order chest radiographs in children with uncomplicated asthma or bronchiolitis.
2. Don’t routinely use bronchodilators in children with bronchiolitis.
3. Don’t use systemic corticosteroids in children under 2 years of age with an uncomplicated lower respiratory tract infection.
4. Don’t treat gastroesophageal reflux in infants routinely with acid suppression therapy.
5. Don’t use continuous pulse oximetry routinely in children with acute respiratory illness unless they are on supplemental oxygen.
For complete recommendations and references, visit SHM's website.
SHM has joined the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely campaign, a multiyear effort to spark national dialogue about waste in the healthcare system and the kinds of common treatments that doctors and patients should think twice about before deciding to pursue. Ad hoc subcommittees of SHM’s Hospital Quality and Patient Safety Committee created lists of five adult and five pediatric treatments that hospitalists and their patients should question (see below). Those lists were shared alongside 15 other medical specialty societies at a Feb. 21 news conference in Washington, D.C.
Adult Hospitalist "Avoid List"
1. Do not place, or leave in place, urinary catheters for incontinence or convenience or monitoring of output for non-critically ill patients (acceptable indications: critical illness, obstruction, hospice, perioperatively for <2 days for urologic procedures; use weights instead to monitor diuresis).
2. Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless at high risk for GI complications.
3. Avoid transfusions of red blood cells for arbitrary hemoglobin or hematocrit thresholds and in the absence of symptoms or active coronary disease, heart failure or stroke.
4. Do not order continuous telemetry monitoring outside of the ICU without using a protocol that governs continuation.
5. Do not perform repetitive CBC and chemistry testing in the face of clinical and lab stability.
Pediatric HospitalIST "Avoid List"
1. Don’t order chest radiographs in children with uncomplicated asthma or bronchiolitis.
2. Don’t routinely use bronchodilators in children with bronchiolitis.
3. Don’t use systemic corticosteroids in children under 2 years of age with an uncomplicated lower respiratory tract infection.
4. Don’t treat gastroesophageal reflux in infants routinely with acid suppression therapy.
5. Don’t use continuous pulse oximetry routinely in children with acute respiratory illness unless they are on supplemental oxygen.
For complete recommendations and references, visit SHM's website.
Better Choices, Better Healthcare
WASHINGTON, D.C.—SHM joined hands today with 15 other U.S. medical specialty societies in the fight to eliminate wasteful medical tests, drugs, and treatments.
The 10,000-member SHM, which represents more than 40,000 hospitalists, released two lists of common tests and procedures that clinicians and patients should seriously question as part of the ABIM Foundation’s Choosing Wisely campaign. The campaign debuted in April 2012 with nine medical societies providing input on medical decisions that lack evidence, waste finite healthcare resources, or potentially harm patients.
“We acknowledge that there is waste in our system,” says Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation. “We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.”
SHM’s Hospital Quality and Patient Safety Committee created two lists of five recommendations: one for adult hospitalists and inpatients, and one for pediatric hospitalists and patients. Examples include:
- Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless they are at high risk for gastrointestinal complications;
- Do not order continuous telemetry monitoring outside the ICU without using a protocol that governs its continuation; and
- Do not order chest radiography in children who have uncomplicated asthma or bronchiolitis.
The “avoid” lists were chosen by SHM because they potentially represent significant, needless waste of healthcare resources, according to John Bulger, DO, MBA, SFHM, chief quality officer at Geisinger Medical Center in Danville, Pa. Dr. Bulger, who chaired SHM’s Choosing Wisely committee, encourages hospitalists to stop and take a long look at the list and think about ways to improve their own practice. He encourages hospitalists to take the recommendations to their hospitals’ quality-improvement (QI) committee and start collecting baseline data, he says. “We should be able to come back a year from now and show that we’ve been able to change practice using these lists,” he says.
—Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation
HM pioneer Robert Wachter, MD, MHM, who heads the division of hospital medicine at the University of California at San Francisco, chairs the American Board of Internal Medicine, and sits on the board of the ABIM Foundation, agrees.
“I think you’ll be hearing similar kinds of drumbeats about waste from every national organization involved in healthcare,” says Dr. Wachter, author of the Wachter’s World blog. “I think hospitalists should be active and enthusiastic partners in the Choosing Wisely campaign and leaders in American healthcare’s efforts to figure out how to purge waste from the system and decrease unnecessary expense.”
Click here to listen to more of Dr. Wachter’s interview on the Choosing Wisely campaign.
A similar kind of focus on efficiency and cost-effectiveness was part of the initial motivation for developing hospital medicine, Dr. Wachter says. He compares the current national obsession about healthcare waste with the medical quality and patient safety movements of the past decade.
“It’s the right time, the right message, and the right messenger,” he says. “But now we’re a little scared about raised expectations. Delivering on them is going to be more difficult, even, than patient safety was because, ultimately, it will require curtailing some income streams. You can’t reach the final outcome of cutting costs in healthcare without someone making less money.” TH
Larry Beresford is a freelance writer in Oakland, Calif.
CHoosing Wisely
Who: Sponsored by the ABIM Foundation, the campaign includes 25 medical specialty societies.
What: A national quality campaign to educate physicians and patients about wasteful medical tests, procedures, and treatments.
When: Launched April 4, 2012.
Why: Treatments that are commonly ordered but not supported by medical research are not only potentially wasteful of finite healthcare resources, but they also could harm patients.
More: Check out the complete adult and pediatric HM "avoid" lists.
WASHINGTON, D.C.—SHM joined hands today with 15 other U.S. medical specialty societies in the fight to eliminate wasteful medical tests, drugs, and treatments.
The 10,000-member SHM, which represents more than 40,000 hospitalists, released two lists of common tests and procedures that clinicians and patients should seriously question as part of the ABIM Foundation’s Choosing Wisely campaign. The campaign debuted in April 2012 with nine medical societies providing input on medical decisions that lack evidence, waste finite healthcare resources, or potentially harm patients.
“We acknowledge that there is waste in our system,” says Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation. “We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.”
SHM’s Hospital Quality and Patient Safety Committee created two lists of five recommendations: one for adult hospitalists and inpatients, and one for pediatric hospitalists and patients. Examples include:
- Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless they are at high risk for gastrointestinal complications;
- Do not order continuous telemetry monitoring outside the ICU without using a protocol that governs its continuation; and
- Do not order chest radiography in children who have uncomplicated asthma or bronchiolitis.
The “avoid” lists were chosen by SHM because they potentially represent significant, needless waste of healthcare resources, according to John Bulger, DO, MBA, SFHM, chief quality officer at Geisinger Medical Center in Danville, Pa. Dr. Bulger, who chaired SHM’s Choosing Wisely committee, encourages hospitalists to stop and take a long look at the list and think about ways to improve their own practice. He encourages hospitalists to take the recommendations to their hospitals’ quality-improvement (QI) committee and start collecting baseline data, he says. “We should be able to come back a year from now and show that we’ve been able to change practice using these lists,” he says.
—Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation
HM pioneer Robert Wachter, MD, MHM, who heads the division of hospital medicine at the University of California at San Francisco, chairs the American Board of Internal Medicine, and sits on the board of the ABIM Foundation, agrees.
“I think you’ll be hearing similar kinds of drumbeats about waste from every national organization involved in healthcare,” says Dr. Wachter, author of the Wachter’s World blog. “I think hospitalists should be active and enthusiastic partners in the Choosing Wisely campaign and leaders in American healthcare’s efforts to figure out how to purge waste from the system and decrease unnecessary expense.”
Click here to listen to more of Dr. Wachter’s interview on the Choosing Wisely campaign.
A similar kind of focus on efficiency and cost-effectiveness was part of the initial motivation for developing hospital medicine, Dr. Wachter says. He compares the current national obsession about healthcare waste with the medical quality and patient safety movements of the past decade.
“It’s the right time, the right message, and the right messenger,” he says. “But now we’re a little scared about raised expectations. Delivering on them is going to be more difficult, even, than patient safety was because, ultimately, it will require curtailing some income streams. You can’t reach the final outcome of cutting costs in healthcare without someone making less money.” TH
Larry Beresford is a freelance writer in Oakland, Calif.
CHoosing Wisely
Who: Sponsored by the ABIM Foundation, the campaign includes 25 medical specialty societies.
What: A national quality campaign to educate physicians and patients about wasteful medical tests, procedures, and treatments.
When: Launched April 4, 2012.
Why: Treatments that are commonly ordered but not supported by medical research are not only potentially wasteful of finite healthcare resources, but they also could harm patients.
More: Check out the complete adult and pediatric HM "avoid" lists.
WASHINGTON, D.C.—SHM joined hands today with 15 other U.S. medical specialty societies in the fight to eliminate wasteful medical tests, drugs, and treatments.
The 10,000-member SHM, which represents more than 40,000 hospitalists, released two lists of common tests and procedures that clinicians and patients should seriously question as part of the ABIM Foundation’s Choosing Wisely campaign. The campaign debuted in April 2012 with nine medical societies providing input on medical decisions that lack evidence, waste finite healthcare resources, or potentially harm patients.
“We acknowledge that there is waste in our system,” says Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation. “We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.”
SHM’s Hospital Quality and Patient Safety Committee created two lists of five recommendations: one for adult hospitalists and inpatients, and one for pediatric hospitalists and patients. Examples include:
- Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless they are at high risk for gastrointestinal complications;
- Do not order continuous telemetry monitoring outside the ICU without using a protocol that governs its continuation; and
- Do not order chest radiography in children who have uncomplicated asthma or bronchiolitis.
The “avoid” lists were chosen by SHM because they potentially represent significant, needless waste of healthcare resources, according to John Bulger, DO, MBA, SFHM, chief quality officer at Geisinger Medical Center in Danville, Pa. Dr. Bulger, who chaired SHM’s Choosing Wisely committee, encourages hospitalists to stop and take a long look at the list and think about ways to improve their own practice. He encourages hospitalists to take the recommendations to their hospitals’ quality-improvement (QI) committee and start collecting baseline data, he says. “We should be able to come back a year from now and show that we’ve been able to change practice using these lists,” he says.
—Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation
HM pioneer Robert Wachter, MD, MHM, who heads the division of hospital medicine at the University of California at San Francisco, chairs the American Board of Internal Medicine, and sits on the board of the ABIM Foundation, agrees.
“I think you’ll be hearing similar kinds of drumbeats about waste from every national organization involved in healthcare,” says Dr. Wachter, author of the Wachter’s World blog. “I think hospitalists should be active and enthusiastic partners in the Choosing Wisely campaign and leaders in American healthcare’s efforts to figure out how to purge waste from the system and decrease unnecessary expense.”
Click here to listen to more of Dr. Wachter’s interview on the Choosing Wisely campaign.
A similar kind of focus on efficiency and cost-effectiveness was part of the initial motivation for developing hospital medicine, Dr. Wachter says. He compares the current national obsession about healthcare waste with the medical quality and patient safety movements of the past decade.
“It’s the right time, the right message, and the right messenger,” he says. “But now we’re a little scared about raised expectations. Delivering on them is going to be more difficult, even, than patient safety was because, ultimately, it will require curtailing some income streams. You can’t reach the final outcome of cutting costs in healthcare without someone making less money.” TH
Larry Beresford is a freelance writer in Oakland, Calif.
CHoosing Wisely
Who: Sponsored by the ABIM Foundation, the campaign includes 25 medical specialty societies.
What: A national quality campaign to educate physicians and patients about wasteful medical tests, procedures, and treatments.
When: Launched April 4, 2012.
Why: Treatments that are commonly ordered but not supported by medical research are not only potentially wasteful of finite healthcare resources, but they also could harm patients.
More: Check out the complete adult and pediatric HM "avoid" lists.
Hospitalists Earn High Marks in Patient Care Survey
The lead author of a new report that says hospitalized Medicare patients are happier in facilities using a greater number of hospitalists didn't expect that would be the case.
The study, "Hospitalist Staffing and Patient Satisfaction in the National Medicare Population," which was recently published in the Journal of Hospital Medicine, sprung from the theory that hospitals using a large number of hospitalists generally would rank lower in patient satisfaction than others. In part, the expectation was tied to the belief that patients might prefer to be seen by their primary-care physician (PCP) rather than a hospitalist.
"What we'd like people to take away is that in our study—and it's only one study—hospitals with higher levels of hospitalist care had modestly higher patient satisfaction scores, especially in the areas of discharge planning and overall satisfaction," says Lena Chen, MD, MS, clinical lecturer in the division of general medicine at the University of Michigan in Ann Arbor. "It suggests that there doesn't need to be a tradeoff between greater use of hospitalist services and patient satisfaction."
The retrospective cohort study looked at 2,843 acute-care hospitals and split them into groups ranked by the percentage of patients cared for by hospitalists. Those categorized as "nonhospitalist" hospitals had a median of 0% of general medicine patients cared for by hospitalists; a "mixed" hospital had a median of 39.5% of general medicine patients cared for by hospitalists; and a "hospitalist" hospital had a median of 76.5% cared for by hospitalists, according to the report. "Hospitalist" hospitals scored better (65.6%) on global measures of satisfaction than "mixed" (63.9%) or "nonhospitalist" (63.9%) hospitals (P<0.001), the study found. Hospitalist care was not associated with patient satisfaction in the areas of room cleanliness or communication with a physician.
Dr. Chen says she would like to see the research prompt more investigation into why hospitalist care is associated with patient satisfaction.
"We all want to have satisfied patients," she adds. "It would be important to have research that explores what the factors are that lead to greater patient satisfaction. This is a first step, but it's definitely not the end of the road."
Visit our website for more information about patient satisfaction.
The lead author of a new report that says hospitalized Medicare patients are happier in facilities using a greater number of hospitalists didn't expect that would be the case.
The study, "Hospitalist Staffing and Patient Satisfaction in the National Medicare Population," which was recently published in the Journal of Hospital Medicine, sprung from the theory that hospitals using a large number of hospitalists generally would rank lower in patient satisfaction than others. In part, the expectation was tied to the belief that patients might prefer to be seen by their primary-care physician (PCP) rather than a hospitalist.
"What we'd like people to take away is that in our study—and it's only one study—hospitals with higher levels of hospitalist care had modestly higher patient satisfaction scores, especially in the areas of discharge planning and overall satisfaction," says Lena Chen, MD, MS, clinical lecturer in the division of general medicine at the University of Michigan in Ann Arbor. "It suggests that there doesn't need to be a tradeoff between greater use of hospitalist services and patient satisfaction."
The retrospective cohort study looked at 2,843 acute-care hospitals and split them into groups ranked by the percentage of patients cared for by hospitalists. Those categorized as "nonhospitalist" hospitals had a median of 0% of general medicine patients cared for by hospitalists; a "mixed" hospital had a median of 39.5% of general medicine patients cared for by hospitalists; and a "hospitalist" hospital had a median of 76.5% cared for by hospitalists, according to the report. "Hospitalist" hospitals scored better (65.6%) on global measures of satisfaction than "mixed" (63.9%) or "nonhospitalist" (63.9%) hospitals (P<0.001), the study found. Hospitalist care was not associated with patient satisfaction in the areas of room cleanliness or communication with a physician.
Dr. Chen says she would like to see the research prompt more investigation into why hospitalist care is associated with patient satisfaction.
"We all want to have satisfied patients," she adds. "It would be important to have research that explores what the factors are that lead to greater patient satisfaction. This is a first step, but it's definitely not the end of the road."
Visit our website for more information about patient satisfaction.
The lead author of a new report that says hospitalized Medicare patients are happier in facilities using a greater number of hospitalists didn't expect that would be the case.
The study, "Hospitalist Staffing and Patient Satisfaction in the National Medicare Population," which was recently published in the Journal of Hospital Medicine, sprung from the theory that hospitals using a large number of hospitalists generally would rank lower in patient satisfaction than others. In part, the expectation was tied to the belief that patients might prefer to be seen by their primary-care physician (PCP) rather than a hospitalist.
"What we'd like people to take away is that in our study—and it's only one study—hospitals with higher levels of hospitalist care had modestly higher patient satisfaction scores, especially in the areas of discharge planning and overall satisfaction," says Lena Chen, MD, MS, clinical lecturer in the division of general medicine at the University of Michigan in Ann Arbor. "It suggests that there doesn't need to be a tradeoff between greater use of hospitalist services and patient satisfaction."
The retrospective cohort study looked at 2,843 acute-care hospitals and split them into groups ranked by the percentage of patients cared for by hospitalists. Those categorized as "nonhospitalist" hospitals had a median of 0% of general medicine patients cared for by hospitalists; a "mixed" hospital had a median of 39.5% of general medicine patients cared for by hospitalists; and a "hospitalist" hospital had a median of 76.5% cared for by hospitalists, according to the report. "Hospitalist" hospitals scored better (65.6%) on global measures of satisfaction than "mixed" (63.9%) or "nonhospitalist" (63.9%) hospitals (P<0.001), the study found. Hospitalist care was not associated with patient satisfaction in the areas of room cleanliness or communication with a physician.
Dr. Chen says she would like to see the research prompt more investigation into why hospitalist care is associated with patient satisfaction.
"We all want to have satisfied patients," she adds. "It would be important to have research that explores what the factors are that lead to greater patient satisfaction. This is a first step, but it's definitely not the end of the road."
Visit our website for more information about patient satisfaction.
Drugs, Pregnancy, and Lactation: New Weight Loss Drugs
The need for effective weight management medications as an adjunct to diet and exercise has escalated in the United States as obesity has reached epidemic proportions.
However, in recent years, several Food and Drug Administration–approved medications for weight loss have been plagued with safety concerns and many have been removed from the market, leaving clinicians with limited choices for treatment of overweight or obese patients.
In 2012, two new weight loss medications were approved by the FDA – the first new medications approved for this indication in over a decade (N. Engl. J. Med. 2012;367:1577-9).
As of February 2013, one of the two products, a combination product containing the anorexant phentermine and the anticonvulsant topiramate in an extended-release form, is currently available by prescription in the United States. Marketed as Qysmia, the product is intended to be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese).
The medication is also indicated for adults with a BMI of 27 or greater (overweight) who also have at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The recommended starting daily dose contains 3.75 mg of phentermine and 23 mg of topiramate; the maximum dose contains 15 mg of phentermine and 92 mg of topiramate.
In part, due to concerns about the teratogenicity of topiramate, Qysmia has been designated a category X drug, and specific pregnancy prevention measures in the form of a Risk Evaluation and Mitigation Strategy (REMS) have been put in place. The medication can be obtained only by prescription obtained directly from a health care provider, and providers receive training on the risks of birth defects. A prescription for Qysmia can only be filled by specially certified mail order pharmacies in the United States.
Educational materials indicate that the drug should not be prescribed to women who are pregnant or who are planning on becoming pregnant. Women who are not planning pregnancy but have the potential to become pregnant should have a negative pregnancy test before starting the drug and again every month while taking the drug, and they should use an effective method or combination of methods of contraception. The manufacturer has also initiated a pregnancy surveillance system.
Given the likelihood that many women of reproductive age will use this medication, even with a REMS in place, the potential for unintentional exposure in pregnancy exists. In the inevitable event of an exposed pregnancy, what are the specific risks and their magnitude? The concern about birth defects with this medication stems from previously published data suggesting that topiramate used in monotherapy for other indications, most commonly epilepsy, is associated with an increased risk for oral clefts (cleft lip with or without cleft palate). Although numbers are still small, a few studies have suggested the risk for oral clefts, with the most recent a large pooled case-control analysis from two data sources in the United States (Am. J. Obstet. Gynecol. 2012;207:405e1-7). The pooled estimate of the risk of oral clefts was 5.36 with very wide confidence intervals (1.49-20.07), based on seven exposed children with cleft lip with or without cleft palate. To the extent that this estimate is correct, this translates to an absolute risk of about 5 in 1,000 first-trimester topiramate-exposed pregnancies, compared with a baseline risk of about 1 in 1,000 in unexposed pregnancies.
Published studies of topiramate and oral clefts have not involved sufficient numbers of exposed and affected children to allow examination of a dose threshold; however, the range of recommended doses for seizure prevention in adults treated with topiramate monotherapy (50-400 mg/day) overlaps with the dosing range of topiramate contained in Qysmia. It is important to note that based on the published reports suggesting an increased risk for oral clefts, the pregnancy category for topiramate alone was recently changed from a C to a D, while the pregnancy category for Qysmia is an X. The rationale behind the category D is likely that the benefits of topiramate might outweigh the risks in a pregnant woman with a seizure disorder for whom topiramate is the only effective medication. However, topiramate use for weight loss would typically never be indicated in pregnancy.
The second drug, lorcaserin (Belviq), is a single-ingredient serotonergic medication – a selective agonist of the 5-HT2C receptor. Lorcaserin was approved by the FDA in 2012, but as of February 2013, it is not yet available in the United States. This medication also received a pregnancy category X designation; however, in this situation, it was presumably for the sole reason that intentional weight loss in pregnancy is not recommended. Preclinical data for lorcaserin did not suggest teratogenicity, but maternal exposure in rats late in gestation resulted in lower pup body weight that persisted into adulthood.
To the extent that these new medications are effective in reducing and maintaining BMI within a healthier range in women who are currently overweight or obese, they may lead to improvement in subsequent pregnancy outcomes. However, avoiding exposure to these medications during early pregnancy will be a challenge, even with pregnancy prevention guidance and restricted distribution programs. Postmarketing surveillance for outcomes of inadvertently exposed pregnancies will be essential.
Dr. Chambers is associate professor of pediatrics and family and preventive medicine at the University of California, San Diego. She is director of the California Teratogen Information Service and Clinical Research Program. Dr. Chambers is a past president of the Organization of Teratology Information Specialists and past president of the Teratology Society. She said she had no relevant financial disclosures. To comment, e-mail her at [email protected].
The need for effective weight management medications as an adjunct to diet and exercise has escalated in the United States as obesity has reached epidemic proportions.
However, in recent years, several Food and Drug Administration–approved medications for weight loss have been plagued with safety concerns and many have been removed from the market, leaving clinicians with limited choices for treatment of overweight or obese patients.
In 2012, two new weight loss medications were approved by the FDA – the first new medications approved for this indication in over a decade (N. Engl. J. Med. 2012;367:1577-9).
As of February 2013, one of the two products, a combination product containing the anorexant phentermine and the anticonvulsant topiramate in an extended-release form, is currently available by prescription in the United States. Marketed as Qysmia, the product is intended to be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese).
The medication is also indicated for adults with a BMI of 27 or greater (overweight) who also have at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The recommended starting daily dose contains 3.75 mg of phentermine and 23 mg of topiramate; the maximum dose contains 15 mg of phentermine and 92 mg of topiramate.
In part, due to concerns about the teratogenicity of topiramate, Qysmia has been designated a category X drug, and specific pregnancy prevention measures in the form of a Risk Evaluation and Mitigation Strategy (REMS) have been put in place. The medication can be obtained only by prescription obtained directly from a health care provider, and providers receive training on the risks of birth defects. A prescription for Qysmia can only be filled by specially certified mail order pharmacies in the United States.
Educational materials indicate that the drug should not be prescribed to women who are pregnant or who are planning on becoming pregnant. Women who are not planning pregnancy but have the potential to become pregnant should have a negative pregnancy test before starting the drug and again every month while taking the drug, and they should use an effective method or combination of methods of contraception. The manufacturer has also initiated a pregnancy surveillance system.
Given the likelihood that many women of reproductive age will use this medication, even with a REMS in place, the potential for unintentional exposure in pregnancy exists. In the inevitable event of an exposed pregnancy, what are the specific risks and their magnitude? The concern about birth defects with this medication stems from previously published data suggesting that topiramate used in monotherapy for other indications, most commonly epilepsy, is associated with an increased risk for oral clefts (cleft lip with or without cleft palate). Although numbers are still small, a few studies have suggested the risk for oral clefts, with the most recent a large pooled case-control analysis from two data sources in the United States (Am. J. Obstet. Gynecol. 2012;207:405e1-7). The pooled estimate of the risk of oral clefts was 5.36 with very wide confidence intervals (1.49-20.07), based on seven exposed children with cleft lip with or without cleft palate. To the extent that this estimate is correct, this translates to an absolute risk of about 5 in 1,000 first-trimester topiramate-exposed pregnancies, compared with a baseline risk of about 1 in 1,000 in unexposed pregnancies.
Published studies of topiramate and oral clefts have not involved sufficient numbers of exposed and affected children to allow examination of a dose threshold; however, the range of recommended doses for seizure prevention in adults treated with topiramate monotherapy (50-400 mg/day) overlaps with the dosing range of topiramate contained in Qysmia. It is important to note that based on the published reports suggesting an increased risk for oral clefts, the pregnancy category for topiramate alone was recently changed from a C to a D, while the pregnancy category for Qysmia is an X. The rationale behind the category D is likely that the benefits of topiramate might outweigh the risks in a pregnant woman with a seizure disorder for whom topiramate is the only effective medication. However, topiramate use for weight loss would typically never be indicated in pregnancy.
The second drug, lorcaserin (Belviq), is a single-ingredient serotonergic medication – a selective agonist of the 5-HT2C receptor. Lorcaserin was approved by the FDA in 2012, but as of February 2013, it is not yet available in the United States. This medication also received a pregnancy category X designation; however, in this situation, it was presumably for the sole reason that intentional weight loss in pregnancy is not recommended. Preclinical data for lorcaserin did not suggest teratogenicity, but maternal exposure in rats late in gestation resulted in lower pup body weight that persisted into adulthood.
To the extent that these new medications are effective in reducing and maintaining BMI within a healthier range in women who are currently overweight or obese, they may lead to improvement in subsequent pregnancy outcomes. However, avoiding exposure to these medications during early pregnancy will be a challenge, even with pregnancy prevention guidance and restricted distribution programs. Postmarketing surveillance for outcomes of inadvertently exposed pregnancies will be essential.
Dr. Chambers is associate professor of pediatrics and family and preventive medicine at the University of California, San Diego. She is director of the California Teratogen Information Service and Clinical Research Program. Dr. Chambers is a past president of the Organization of Teratology Information Specialists and past president of the Teratology Society. She said she had no relevant financial disclosures. To comment, e-mail her at [email protected].
The need for effective weight management medications as an adjunct to diet and exercise has escalated in the United States as obesity has reached epidemic proportions.
However, in recent years, several Food and Drug Administration–approved medications for weight loss have been plagued with safety concerns and many have been removed from the market, leaving clinicians with limited choices for treatment of overweight or obese patients.
In 2012, two new weight loss medications were approved by the FDA – the first new medications approved for this indication in over a decade (N. Engl. J. Med. 2012;367:1577-9).
As of February 2013, one of the two products, a combination product containing the anorexant phentermine and the anticonvulsant topiramate in an extended-release form, is currently available by prescription in the United States. Marketed as Qysmia, the product is intended to be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese).
The medication is also indicated for adults with a BMI of 27 or greater (overweight) who also have at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The recommended starting daily dose contains 3.75 mg of phentermine and 23 mg of topiramate; the maximum dose contains 15 mg of phentermine and 92 mg of topiramate.
In part, due to concerns about the teratogenicity of topiramate, Qysmia has been designated a category X drug, and specific pregnancy prevention measures in the form of a Risk Evaluation and Mitigation Strategy (REMS) have been put in place. The medication can be obtained only by prescription obtained directly from a health care provider, and providers receive training on the risks of birth defects. A prescription for Qysmia can only be filled by specially certified mail order pharmacies in the United States.
Educational materials indicate that the drug should not be prescribed to women who are pregnant or who are planning on becoming pregnant. Women who are not planning pregnancy but have the potential to become pregnant should have a negative pregnancy test before starting the drug and again every month while taking the drug, and they should use an effective method or combination of methods of contraception. The manufacturer has also initiated a pregnancy surveillance system.
Given the likelihood that many women of reproductive age will use this medication, even with a REMS in place, the potential for unintentional exposure in pregnancy exists. In the inevitable event of an exposed pregnancy, what are the specific risks and their magnitude? The concern about birth defects with this medication stems from previously published data suggesting that topiramate used in monotherapy for other indications, most commonly epilepsy, is associated with an increased risk for oral clefts (cleft lip with or without cleft palate). Although numbers are still small, a few studies have suggested the risk for oral clefts, with the most recent a large pooled case-control analysis from two data sources in the United States (Am. J. Obstet. Gynecol. 2012;207:405e1-7). The pooled estimate of the risk of oral clefts was 5.36 with very wide confidence intervals (1.49-20.07), based on seven exposed children with cleft lip with or without cleft palate. To the extent that this estimate is correct, this translates to an absolute risk of about 5 in 1,000 first-trimester topiramate-exposed pregnancies, compared with a baseline risk of about 1 in 1,000 in unexposed pregnancies.
Published studies of topiramate and oral clefts have not involved sufficient numbers of exposed and affected children to allow examination of a dose threshold; however, the range of recommended doses for seizure prevention in adults treated with topiramate monotherapy (50-400 mg/day) overlaps with the dosing range of topiramate contained in Qysmia. It is important to note that based on the published reports suggesting an increased risk for oral clefts, the pregnancy category for topiramate alone was recently changed from a C to a D, while the pregnancy category for Qysmia is an X. The rationale behind the category D is likely that the benefits of topiramate might outweigh the risks in a pregnant woman with a seizure disorder for whom topiramate is the only effective medication. However, topiramate use for weight loss would typically never be indicated in pregnancy.
The second drug, lorcaserin (Belviq), is a single-ingredient serotonergic medication – a selective agonist of the 5-HT2C receptor. Lorcaserin was approved by the FDA in 2012, but as of February 2013, it is not yet available in the United States. This medication also received a pregnancy category X designation; however, in this situation, it was presumably for the sole reason that intentional weight loss in pregnancy is not recommended. Preclinical data for lorcaserin did not suggest teratogenicity, but maternal exposure in rats late in gestation resulted in lower pup body weight that persisted into adulthood.
To the extent that these new medications are effective in reducing and maintaining BMI within a healthier range in women who are currently overweight or obese, they may lead to improvement in subsequent pregnancy outcomes. However, avoiding exposure to these medications during early pregnancy will be a challenge, even with pregnancy prevention guidance and restricted distribution programs. Postmarketing surveillance for outcomes of inadvertently exposed pregnancies will be essential.
Dr. Chambers is associate professor of pediatrics and family and preventive medicine at the University of California, San Diego. She is director of the California Teratogen Information Service and Clinical Research Program. Dr. Chambers is a past president of the Organization of Teratology Information Specialists and past president of the Teratology Society. She said she had no relevant financial disclosures. To comment, e-mail her at [email protected].
Company suspends enrollment in drug trials
Credit: Esther Dyson
After 2 deaths among patients receiving the BCL-2 inhibitor ABT-199, the company developing the drug has suspended enrollment in 5 trials and stopped dose-escalation of the drug.
The patients died of tumor lysis syndrome, a complication that likely stems from the drug’s potency, according to Tracy Sorrentino, a spokeswoman for the company, AbbVie.
Research has suggested the risk of tumor lysis syndrome might be eliminated by altering the dose of ABT-199, Sorrentino said.
But until that is confirmed, AbbVie has stopped dose-escalation in patients receiving ABT-199 and voluntarily suspended enrollment in phase 1 trials of the drug.
The trials are testing ABT-199, both alone and in combination, as a treatment for chronic lymphocytic leukemia, non-Hodgkin lymphoma, and small lymphocytic lymphoma.
Though enrollment has stopped for these trials, dosing of active patients in ABT-199 trials will continue. In addition, a study testing ABT-199 in women with systemic lupus erythematosus is still enrolling patients.
Sorrentino said AbbVie has “every expectation” the suspended enrollment is temporary, and refining the dose of ABT-199 may eliminate the problem. In fact, the company is still planning to begin phase 3 trials of the drug later this year. 
Credit: Esther Dyson
After 2 deaths among patients receiving the BCL-2 inhibitor ABT-199, the company developing the drug has suspended enrollment in 5 trials and stopped dose-escalation of the drug.
The patients died of tumor lysis syndrome, a complication that likely stems from the drug’s potency, according to Tracy Sorrentino, a spokeswoman for the company, AbbVie.
Research has suggested the risk of tumor lysis syndrome might be eliminated by altering the dose of ABT-199, Sorrentino said.
But until that is confirmed, AbbVie has stopped dose-escalation in patients receiving ABT-199 and voluntarily suspended enrollment in phase 1 trials of the drug.
The trials are testing ABT-199, both alone and in combination, as a treatment for chronic lymphocytic leukemia, non-Hodgkin lymphoma, and small lymphocytic lymphoma.
Though enrollment has stopped for these trials, dosing of active patients in ABT-199 trials will continue. In addition, a study testing ABT-199 in women with systemic lupus erythematosus is still enrolling patients.
Sorrentino said AbbVie has “every expectation” the suspended enrollment is temporary, and refining the dose of ABT-199 may eliminate the problem. In fact, the company is still planning to begin phase 3 trials of the drug later this year.
Credit: Esther Dyson
After 2 deaths among patients receiving the BCL-2 inhibitor ABT-199, the company developing the drug has suspended enrollment in 5 trials and stopped dose-escalation of the drug.
The patients died of tumor lysis syndrome, a complication that likely stems from the drug’s potency, according to Tracy Sorrentino, a spokeswoman for the company, AbbVie.
Research has suggested the risk of tumor lysis syndrome might be eliminated by altering the dose of ABT-199, Sorrentino said.
But until that is confirmed, AbbVie has stopped dose-escalation in patients receiving ABT-199 and voluntarily suspended enrollment in phase 1 trials of the drug.
The trials are testing ABT-199, both alone and in combination, as a treatment for chronic lymphocytic leukemia, non-Hodgkin lymphoma, and small lymphocytic lymphoma.
Though enrollment has stopped for these trials, dosing of active patients in ABT-199 trials will continue. In addition, a study testing ABT-199 in women with systemic lupus erythematosus is still enrolling patients.
Sorrentino said AbbVie has “every expectation” the suspended enrollment is temporary, and refining the dose of ABT-199 may eliminate the problem. In fact, the company is still planning to begin phase 3 trials of the drug later this year.
Neonates at highest risk for Ebstein’s malformation treatment
LOS ANGELES – Neonates in particular are at risk for poor outcomes from Ebstein’s malformation, showing significantly higher mortality than infants, children, and adults, according to a database study presented by Dr. Ryan R. Davies at the annual meeting of the Society of Thoracic Surgeons.
Ebstein’s malformation is a rare congenital cardiac anomaly. Surgery for Ebstein’s involves a range of procedures, and with low institutional volumes, the only available data on treatment have been limited to individual reports demonstrating highly variable approaches.
Dr. Davies of the Nemours/A.I. duPont Hospital for Children, Wilmington, Del., and his colleagues performed a retrospective study of procedures performed on patients with a primary diagnosis of Ebstein’s malformation (2002-2009) in the STS Congenital Heart Surgery Database.
A total of 595 operations on patients with Ebstein’s were included: 116 on neonates (19%), 122 on infants (21%), 264 on children (44%), and 93 on adults (16%). The authors found that average annual institutional case volumes were low (median, 1 case/year), and procedures varied according to age. Neonates had a high rate of palliative procedures: tricuspid valve (TV) closure (16%) and systemic-to-pulmonary shunts with or without TV closure (37%) and isolated TV closure (8.6%), with Ebstein’s repair or TV valvuloplasty performed in 32%.
Infants usually underwent superior cavopulmonary connections (52%).
Among older patients, procedures were mostly in three categories: TV surgery (children, 55%; adults, 69%), arrhythmia procedures (children, 9%; adults, 17%), and Fontan (children, 16%). In-hospital mortality was higher among neonatal patients (23%) than in infants (4%), children (0.8%), and adults (1.1%).
Among neonates, 36 subsequent procedures were performed during the same hospitalization in 27 patients (23%); including TV closure (11%); shunt (15%); Ebstein’s repair (17%) or TV replacement (15%); and heart transplantation (7.4%). Mortality was similar among neonates who had a second procedure and those who did not (27% vs. 23%, respectively). ECMO (extracorporeal membrane oxygenation) was used in 9% of neonates but in less than 2% of patients in other age groups.
"This study represents a broad overview of the diverse options for surgical treatment of Ebstein’s anomaly. It shows the challenges faced in caring for extremely ill neonatal patients. We have also shown that repair of Ebstein’s anomaly is performed infrequently at most centers, limiting the ability of individual series to define optimal management strategies," Dr. Davies said in an interview.
"Unfortunately, currently available databases do not contain information that may be important in defining such strategies (both surgical and nonsurgical), including anatomic and physiologic variables – whether they are neonates presenting in severe heart failure or older patients presenting for tricuspid valve repair or replacement," he added.
"We feel that in this setting, a prospective multi-institutional study would be of significant value. It should include operative and nonoperative patients, as well as precise diagnostic information and procedural details, to evaluate long-term outcomes including survival, reoperation and other reinterventions, as well as neurodevelopmental outcomes, functional health status, and quality of life," Dr. Davies concluded.
Dr. Davies and his colleagues reported having no relevant disclosures.
LOS ANGELES – Neonates in particular are at risk for poor outcomes from Ebstein’s malformation, showing significantly higher mortality than infants, children, and adults, according to a database study presented by Dr. Ryan R. Davies at the annual meeting of the Society of Thoracic Surgeons.
Ebstein’s malformation is a rare congenital cardiac anomaly. Surgery for Ebstein’s involves a range of procedures, and with low institutional volumes, the only available data on treatment have been limited to individual reports demonstrating highly variable approaches.
Dr. Davies of the Nemours/A.I. duPont Hospital for Children, Wilmington, Del., and his colleagues performed a retrospective study of procedures performed on patients with a primary diagnosis of Ebstein’s malformation (2002-2009) in the STS Congenital Heart Surgery Database.
A total of 595 operations on patients with Ebstein’s were included: 116 on neonates (19%), 122 on infants (21%), 264 on children (44%), and 93 on adults (16%). The authors found that average annual institutional case volumes were low (median, 1 case/year), and procedures varied according to age. Neonates had a high rate of palliative procedures: tricuspid valve (TV) closure (16%) and systemic-to-pulmonary shunts with or without TV closure (37%) and isolated TV closure (8.6%), with Ebstein’s repair or TV valvuloplasty performed in 32%.
Infants usually underwent superior cavopulmonary connections (52%).
Among older patients, procedures were mostly in three categories: TV surgery (children, 55%; adults, 69%), arrhythmia procedures (children, 9%; adults, 17%), and Fontan (children, 16%). In-hospital mortality was higher among neonatal patients (23%) than in infants (4%), children (0.8%), and adults (1.1%).
Among neonates, 36 subsequent procedures were performed during the same hospitalization in 27 patients (23%); including TV closure (11%); shunt (15%); Ebstein’s repair (17%) or TV replacement (15%); and heart transplantation (7.4%). Mortality was similar among neonates who had a second procedure and those who did not (27% vs. 23%, respectively). ECMO (extracorporeal membrane oxygenation) was used in 9% of neonates but in less than 2% of patients in other age groups.
"This study represents a broad overview of the diverse options for surgical treatment of Ebstein’s anomaly. It shows the challenges faced in caring for extremely ill neonatal patients. We have also shown that repair of Ebstein’s anomaly is performed infrequently at most centers, limiting the ability of individual series to define optimal management strategies," Dr. Davies said in an interview.
"Unfortunately, currently available databases do not contain information that may be important in defining such strategies (both surgical and nonsurgical), including anatomic and physiologic variables – whether they are neonates presenting in severe heart failure or older patients presenting for tricuspid valve repair or replacement," he added.
"We feel that in this setting, a prospective multi-institutional study would be of significant value. It should include operative and nonoperative patients, as well as precise diagnostic information and procedural details, to evaluate long-term outcomes including survival, reoperation and other reinterventions, as well as neurodevelopmental outcomes, functional health status, and quality of life," Dr. Davies concluded.
Dr. Davies and his colleagues reported having no relevant disclosures.
LOS ANGELES – Neonates in particular are at risk for poor outcomes from Ebstein’s malformation, showing significantly higher mortality than infants, children, and adults, according to a database study presented by Dr. Ryan R. Davies at the annual meeting of the Society of Thoracic Surgeons.
Ebstein’s malformation is a rare congenital cardiac anomaly. Surgery for Ebstein’s involves a range of procedures, and with low institutional volumes, the only available data on treatment have been limited to individual reports demonstrating highly variable approaches.
Dr. Davies of the Nemours/A.I. duPont Hospital for Children, Wilmington, Del., and his colleagues performed a retrospective study of procedures performed on patients with a primary diagnosis of Ebstein’s malformation (2002-2009) in the STS Congenital Heart Surgery Database.
A total of 595 operations on patients with Ebstein’s were included: 116 on neonates (19%), 122 on infants (21%), 264 on children (44%), and 93 on adults (16%). The authors found that average annual institutional case volumes were low (median, 1 case/year), and procedures varied according to age. Neonates had a high rate of palliative procedures: tricuspid valve (TV) closure (16%) and systemic-to-pulmonary shunts with or without TV closure (37%) and isolated TV closure (8.6%), with Ebstein’s repair or TV valvuloplasty performed in 32%.
Infants usually underwent superior cavopulmonary connections (52%).
Among older patients, procedures were mostly in three categories: TV surgery (children, 55%; adults, 69%), arrhythmia procedures (children, 9%; adults, 17%), and Fontan (children, 16%). In-hospital mortality was higher among neonatal patients (23%) than in infants (4%), children (0.8%), and adults (1.1%).
Among neonates, 36 subsequent procedures were performed during the same hospitalization in 27 patients (23%); including TV closure (11%); shunt (15%); Ebstein’s repair (17%) or TV replacement (15%); and heart transplantation (7.4%). Mortality was similar among neonates who had a second procedure and those who did not (27% vs. 23%, respectively). ECMO (extracorporeal membrane oxygenation) was used in 9% of neonates but in less than 2% of patients in other age groups.
"This study represents a broad overview of the diverse options for surgical treatment of Ebstein’s anomaly. It shows the challenges faced in caring for extremely ill neonatal patients. We have also shown that repair of Ebstein’s anomaly is performed infrequently at most centers, limiting the ability of individual series to define optimal management strategies," Dr. Davies said in an interview.
"Unfortunately, currently available databases do not contain information that may be important in defining such strategies (both surgical and nonsurgical), including anatomic and physiologic variables – whether they are neonates presenting in severe heart failure or older patients presenting for tricuspid valve repair or replacement," he added.
"We feel that in this setting, a prospective multi-institutional study would be of significant value. It should include operative and nonoperative patients, as well as precise diagnostic information and procedural details, to evaluate long-term outcomes including survival, reoperation and other reinterventions, as well as neurodevelopmental outcomes, functional health status, and quality of life," Dr. Davies concluded.
Dr. Davies and his colleagues reported having no relevant disclosures.
AT THE STS ANNUAL MEETING
Major Finding: In-hospital mortality was higher among neonatal patients (23%) than in infants (4%), children (0.8%), and adults (1.1%).
Data Source: A retrospective database analysis of 595 operations on patients with Ebstein’s malformation.
Disclosures: Dr. Davies and his colleagues reported having no relevant disclosures.
Hold your hoarseness: Tips for tackling challenging cases
WASHINGTON – If your patient complains of hoarseness, how do you handle it? Although the causes of hoarseness are often obvious, many patients with hoarseness have vocal folds that appear normal, which can create a diagnostic challenge, said Dr. Seth M. Cohen of Duke University Medical Center in Durham, N.C., and Dr. J. Pieter Noordzij of Boston Medical Center.
Some of the most common causes of hoarseness in patients with normal-looking vocal folds are muscle tension/functional dysphonia, spasmodic dysphonia, vocal fold tremor, Parkinson’s disease, presbylaryngis (vocal fold atrophy), and amyotrophic lateral sclerosis. Dr. Cohen and Dr. Noordzij reviewed these conditions and shared cases at the annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery Foundation.
The Work-Up
When evaluating a patient’s hoarseness, start with a history and physical exam. The history should include the duration of hoarseness, how it started, family history of hoarseness, and the patient’s vocal demands that could contribute to overuse of the voice, Dr. Cohen said. Fluid intake (or lack of) can play a role, as can certain medical conditions such as gastroesophageal reflux disease (GERD) and allergies involving postnasal drip, he said.
The complete evaluation of a hoarse patient should include a full head and neck exam and a full cranial nerve exam, as well as an assessment of general appearance, facial expression, and endolaryngeal findings, Dr. Cohen said.
In addition, clinicians can use a perceptual voice analysis to try to characterize the general voice quality in terms of roughness (raspy), breathiness, strain (voice breaking), pitch (may be lower than normal), articulation, and speed, Dr. Cohen said. Techniques to evaluate patients include asking them to whisper, sing, make sustained vowel sounds (aaah, eee, ooo), and count from 60 to 69 and from 80 to 89.
Although some patients with hoarseness may benefit from surgical procedures, voice therapy is usually the first choice for treatment, he noted.
"Listen to the patient, listen to what they tell you, and listen to what they sound like," Dr. Cohen said.
Muscle Tension/Functional Dysphonia
Patients with muscle tension and functional dysphonia have excessive tension or poor coordination of the muscles in and near the voice box. The hoarseness in these patients often occurs after a cold and may be worse at the end of the day, said Dr. Noordzij.
On physical exam, this patient’s voice may be raspy and lower in pitch than normal. Someone who puts heavy demands on their voice might be susceptible to this condition, Dr. Noordzij said. They perceive their voice as strained and lower pitched, and they feel that are talking at the end of a breath. An endolaryngeal exam may show a gap between the vocal folds and squeezing of the larynx above the vocal folds (called a supraglottic constriction).
Spasmodic Dysphonia
Spasmodic dysphonia (SD) most often occurs in adulthood and can be triggered by a major life stress, Dr. Noordzij said. SD is a neurologic problem, not a functional one, he noted. SD is a movement disorder that involves involuntary, repetitive contractions of the laryngeal muscles. SD may be one of two types: adductor (a spasm that pushes the vocal folds together) or abductor (a spasm that causes the vocal cords to pull apart). Adductor spasmodic dysphonia is the most common form. Vocal characteristics include a strained or strangled voice that breaks on voiced syllables. However, voice breaks do not occur when the patient whispers, sings, or speaks in a falsetto, Dr. Noordzij said.
Vocal Fold Tremor
Vocal tremor is a central nervous system disorder that can be associated with other tremor conditions such as Parkinson’s disease, cerebellar ataxia, and spasmodic dysphonia, Dr. Cohen said.
"The hallmark of the condition is a rhythmic alteration in both the pitch and the loudness," he said. Vocal tremor may be exacerbated by stress or fatigue, and there may be a family history of tremor, he added.
On physical exam, patients with vocal tremor also may have tremor of the hands, head, jaw, voice, pharynx, tongue, or palate. Oscillations of pitch and amplitude are most noticeable during sustained vowels.
Parkinson’s Disease
Patients with Parkinson’s disease can present with voice complaints before they have a Parkinson’s diagnosis, although they also may exhibit Parkinson’s symptoms including hand tremor, rigidity, drooling, or a shuffling gait, Dr. Cohen said.
Hoarseness in these patients is characterized by breathy, flat voice, in a monotone, with breaths at inappropriate times. Patients also may have decreased blinking and a lack of facial expression.
Parkinson’s patients may have a history of not realizing the low volume of their voices, and they may take breaths at inappropriate times, Dr. Cohen noted. An endolaryngeal exam may show evidence of vocal fold bowing and a pooling of secretions, he said.
Presbylaryngis
Presbylaryngis, also known as vocal fold atrophy, is caused by age-related changes in the vocal folds, including ossification of laryngeal cartilage, decreased muscle bulk, decreased mucus production, and thickening or thinning of the epithelium.
"This is one of the hardest problems to treat surgically," Dr. Cohen said. Therefore, voice therapy is the first line treatment, he said.
In general, the pitch of men’s voices rises in cases of presbylaryngis, while the pitch of women’s voices decreases, Dr. Cohen noted. Patients perceive their voices as breathy and weak, with vocal fatigue and decreased ability to project their voices.
Amyotrophic Lateral Sclerosis
Approximately 25% of patients with amyotrophic lateral sclerosis (ALS) present with speech and swallowing problems. ALS is a progressive degeneration of the upper and lower motor neurons. Speech in these patients is typically slow, weak, and hypernasal, said Dr. Cohen. ALS patients may have dysarthria (disturbance of articulation) as well as dysphonia, and involuntary twitches of the tongue, he added.
Neither Dr. Cohen nor Dr. Noordzij had any financial conflicts to disclose.
WASHINGTON – If your patient complains of hoarseness, how do you handle it? Although the causes of hoarseness are often obvious, many patients with hoarseness have vocal folds that appear normal, which can create a diagnostic challenge, said Dr. Seth M. Cohen of Duke University Medical Center in Durham, N.C., and Dr. J. Pieter Noordzij of Boston Medical Center.
Some of the most common causes of hoarseness in patients with normal-looking vocal folds are muscle tension/functional dysphonia, spasmodic dysphonia, vocal fold tremor, Parkinson’s disease, presbylaryngis (vocal fold atrophy), and amyotrophic lateral sclerosis. Dr. Cohen and Dr. Noordzij reviewed these conditions and shared cases at the annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery Foundation.
The Work-Up
When evaluating a patient’s hoarseness, start with a history and physical exam. The history should include the duration of hoarseness, how it started, family history of hoarseness, and the patient’s vocal demands that could contribute to overuse of the voice, Dr. Cohen said. Fluid intake (or lack of) can play a role, as can certain medical conditions such as gastroesophageal reflux disease (GERD) and allergies involving postnasal drip, he said.
The complete evaluation of a hoarse patient should include a full head and neck exam and a full cranial nerve exam, as well as an assessment of general appearance, facial expression, and endolaryngeal findings, Dr. Cohen said.
In addition, clinicians can use a perceptual voice analysis to try to characterize the general voice quality in terms of roughness (raspy), breathiness, strain (voice breaking), pitch (may be lower than normal), articulation, and speed, Dr. Cohen said. Techniques to evaluate patients include asking them to whisper, sing, make sustained vowel sounds (aaah, eee, ooo), and count from 60 to 69 and from 80 to 89.
Although some patients with hoarseness may benefit from surgical procedures, voice therapy is usually the first choice for treatment, he noted.
"Listen to the patient, listen to what they tell you, and listen to what they sound like," Dr. Cohen said.
Muscle Tension/Functional Dysphonia
Patients with muscle tension and functional dysphonia have excessive tension or poor coordination of the muscles in and near the voice box. The hoarseness in these patients often occurs after a cold and may be worse at the end of the day, said Dr. Noordzij.
On physical exam, this patient’s voice may be raspy and lower in pitch than normal. Someone who puts heavy demands on their voice might be susceptible to this condition, Dr. Noordzij said. They perceive their voice as strained and lower pitched, and they feel that are talking at the end of a breath. An endolaryngeal exam may show a gap between the vocal folds and squeezing of the larynx above the vocal folds (called a supraglottic constriction).
Spasmodic Dysphonia
Spasmodic dysphonia (SD) most often occurs in adulthood and can be triggered by a major life stress, Dr. Noordzij said. SD is a neurologic problem, not a functional one, he noted. SD is a movement disorder that involves involuntary, repetitive contractions of the laryngeal muscles. SD may be one of two types: adductor (a spasm that pushes the vocal folds together) or abductor (a spasm that causes the vocal cords to pull apart). Adductor spasmodic dysphonia is the most common form. Vocal characteristics include a strained or strangled voice that breaks on voiced syllables. However, voice breaks do not occur when the patient whispers, sings, or speaks in a falsetto, Dr. Noordzij said.
Vocal Fold Tremor
Vocal tremor is a central nervous system disorder that can be associated with other tremor conditions such as Parkinson’s disease, cerebellar ataxia, and spasmodic dysphonia, Dr. Cohen said.
"The hallmark of the condition is a rhythmic alteration in both the pitch and the loudness," he said. Vocal tremor may be exacerbated by stress or fatigue, and there may be a family history of tremor, he added.
On physical exam, patients with vocal tremor also may have tremor of the hands, head, jaw, voice, pharynx, tongue, or palate. Oscillations of pitch and amplitude are most noticeable during sustained vowels.
Parkinson’s Disease
Patients with Parkinson’s disease can present with voice complaints before they have a Parkinson’s diagnosis, although they also may exhibit Parkinson’s symptoms including hand tremor, rigidity, drooling, or a shuffling gait, Dr. Cohen said.
Hoarseness in these patients is characterized by breathy, flat voice, in a monotone, with breaths at inappropriate times. Patients also may have decreased blinking and a lack of facial expression.
Parkinson’s patients may have a history of not realizing the low volume of their voices, and they may take breaths at inappropriate times, Dr. Cohen noted. An endolaryngeal exam may show evidence of vocal fold bowing and a pooling of secretions, he said.
Presbylaryngis
Presbylaryngis, also known as vocal fold atrophy, is caused by age-related changes in the vocal folds, including ossification of laryngeal cartilage, decreased muscle bulk, decreased mucus production, and thickening or thinning of the epithelium.
"This is one of the hardest problems to treat surgically," Dr. Cohen said. Therefore, voice therapy is the first line treatment, he said.
In general, the pitch of men’s voices rises in cases of presbylaryngis, while the pitch of women’s voices decreases, Dr. Cohen noted. Patients perceive their voices as breathy and weak, with vocal fatigue and decreased ability to project their voices.
Amyotrophic Lateral Sclerosis
Approximately 25% of patients with amyotrophic lateral sclerosis (ALS) present with speech and swallowing problems. ALS is a progressive degeneration of the upper and lower motor neurons. Speech in these patients is typically slow, weak, and hypernasal, said Dr. Cohen. ALS patients may have dysarthria (disturbance of articulation) as well as dysphonia, and involuntary twitches of the tongue, he added.
Neither Dr. Cohen nor Dr. Noordzij had any financial conflicts to disclose.
WASHINGTON – If your patient complains of hoarseness, how do you handle it? Although the causes of hoarseness are often obvious, many patients with hoarseness have vocal folds that appear normal, which can create a diagnostic challenge, said Dr. Seth M. Cohen of Duke University Medical Center in Durham, N.C., and Dr. J. Pieter Noordzij of Boston Medical Center.
Some of the most common causes of hoarseness in patients with normal-looking vocal folds are muscle tension/functional dysphonia, spasmodic dysphonia, vocal fold tremor, Parkinson’s disease, presbylaryngis (vocal fold atrophy), and amyotrophic lateral sclerosis. Dr. Cohen and Dr. Noordzij reviewed these conditions and shared cases at the annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery Foundation.
The Work-Up
When evaluating a patient’s hoarseness, start with a history and physical exam. The history should include the duration of hoarseness, how it started, family history of hoarseness, and the patient’s vocal demands that could contribute to overuse of the voice, Dr. Cohen said. Fluid intake (or lack of) can play a role, as can certain medical conditions such as gastroesophageal reflux disease (GERD) and allergies involving postnasal drip, he said.
The complete evaluation of a hoarse patient should include a full head and neck exam and a full cranial nerve exam, as well as an assessment of general appearance, facial expression, and endolaryngeal findings, Dr. Cohen said.
In addition, clinicians can use a perceptual voice analysis to try to characterize the general voice quality in terms of roughness (raspy), breathiness, strain (voice breaking), pitch (may be lower than normal), articulation, and speed, Dr. Cohen said. Techniques to evaluate patients include asking them to whisper, sing, make sustained vowel sounds (aaah, eee, ooo), and count from 60 to 69 and from 80 to 89.
Although some patients with hoarseness may benefit from surgical procedures, voice therapy is usually the first choice for treatment, he noted.
"Listen to the patient, listen to what they tell you, and listen to what they sound like," Dr. Cohen said.
Muscle Tension/Functional Dysphonia
Patients with muscle tension and functional dysphonia have excessive tension or poor coordination of the muscles in and near the voice box. The hoarseness in these patients often occurs after a cold and may be worse at the end of the day, said Dr. Noordzij.
On physical exam, this patient’s voice may be raspy and lower in pitch than normal. Someone who puts heavy demands on their voice might be susceptible to this condition, Dr. Noordzij said. They perceive their voice as strained and lower pitched, and they feel that are talking at the end of a breath. An endolaryngeal exam may show a gap between the vocal folds and squeezing of the larynx above the vocal folds (called a supraglottic constriction).
Spasmodic Dysphonia
Spasmodic dysphonia (SD) most often occurs in adulthood and can be triggered by a major life stress, Dr. Noordzij said. SD is a neurologic problem, not a functional one, he noted. SD is a movement disorder that involves involuntary, repetitive contractions of the laryngeal muscles. SD may be one of two types: adductor (a spasm that pushes the vocal folds together) or abductor (a spasm that causes the vocal cords to pull apart). Adductor spasmodic dysphonia is the most common form. Vocal characteristics include a strained or strangled voice that breaks on voiced syllables. However, voice breaks do not occur when the patient whispers, sings, or speaks in a falsetto, Dr. Noordzij said.
Vocal Fold Tremor
Vocal tremor is a central nervous system disorder that can be associated with other tremor conditions such as Parkinson’s disease, cerebellar ataxia, and spasmodic dysphonia, Dr. Cohen said.
"The hallmark of the condition is a rhythmic alteration in both the pitch and the loudness," he said. Vocal tremor may be exacerbated by stress or fatigue, and there may be a family history of tremor, he added.
On physical exam, patients with vocal tremor also may have tremor of the hands, head, jaw, voice, pharynx, tongue, or palate. Oscillations of pitch and amplitude are most noticeable during sustained vowels.
Parkinson’s Disease
Patients with Parkinson’s disease can present with voice complaints before they have a Parkinson’s diagnosis, although they also may exhibit Parkinson’s symptoms including hand tremor, rigidity, drooling, or a shuffling gait, Dr. Cohen said.
Hoarseness in these patients is characterized by breathy, flat voice, in a monotone, with breaths at inappropriate times. Patients also may have decreased blinking and a lack of facial expression.
Parkinson’s patients may have a history of not realizing the low volume of their voices, and they may take breaths at inappropriate times, Dr. Cohen noted. An endolaryngeal exam may show evidence of vocal fold bowing and a pooling of secretions, he said.
Presbylaryngis
Presbylaryngis, also known as vocal fold atrophy, is caused by age-related changes in the vocal folds, including ossification of laryngeal cartilage, decreased muscle bulk, decreased mucus production, and thickening or thinning of the epithelium.
"This is one of the hardest problems to treat surgically," Dr. Cohen said. Therefore, voice therapy is the first line treatment, he said.
In general, the pitch of men’s voices rises in cases of presbylaryngis, while the pitch of women’s voices decreases, Dr. Cohen noted. Patients perceive their voices as breathy and weak, with vocal fatigue and decreased ability to project their voices.
Amyotrophic Lateral Sclerosis
Approximately 25% of patients with amyotrophic lateral sclerosis (ALS) present with speech and swallowing problems. ALS is a progressive degeneration of the upper and lower motor neurons. Speech in these patients is typically slow, weak, and hypernasal, said Dr. Cohen. ALS patients may have dysarthria (disturbance of articulation) as well as dysphonia, and involuntary twitches of the tongue, he added.
Neither Dr. Cohen nor Dr. Noordzij had any financial conflicts to disclose.
AT THE ANNUAL MEETING OF THE AMERICAN ACADEMY OF OTOLARYNGOLOGY HEAD AND NECK SURGERY FOUNDATION
PFOs raise stroke risk from devices
LOS ANGELES – Patients with a patent foramen ovale and an implanted defibrillator or pacemaker may be good candidates for targeted closure, based on a review of more than 6,000 patients.
During an average follow-up of nearly 5 years, patients with a PFO who received an implantable cardioverter defibrillator (ICD) or a permanent pacemaker were more than fourfold more likely to develop stroke or transient ischemic attack (TIA) compared with implanted device recipients who did not have a PFO, Dr. Christopher V. DeSimone said at the annual scientific sessions of the American Heart Association.
"We think that this is a high-risk population that might benefit from PFO closure," said Dr. DeSimone, an internal medicine physician at the Mayo Clinic in Rochester, Minn. He acknowledged the poor efficacy of PFO closure for stroke prevention in several recent randomized trials, but noted that patients with a PFO who receive an ICD or permanent pacemaker may constitute a special subgroup that stands to benefit from PFO closure. "If a patient has a right atrial or ventricular lead and a clot forms and sits there next to the PFO, they would be at high risk" for a stroke or TIA, he said in an interview. In fact, trials that have assessed the efficacy of PFO closure explicitly excluded patients with permanent pacemakers as well as many ICD recipients because of their substantially impaired left ventricular function, such as in the CLOSURE I trial (N. Engl. J. Med. 2012;366:991-9). "This needs to be studied prospectively," he added, noting that his study was limited by being retrospective.
Dr. DeSimone and his associates reviewed 6,086 patients who received an ICD or permanent pacemaker at the Mayo Clinic during January 2000 to October 2010. The group included 375 patients with PFOs. Average age of the patients was 67 years; nearly two-thirds were men. About 15% had a history of stroke or TIA, about 44% had atrial fibrillation, and their average CHA2D2-VASc score was 3.1.
During an average follow-up of 4.7 years, the incidence of stroke or TIA was 11% in the PFO patients and 2% in the patients without a PFO. In a multivariate analysis that controlled for baseline demographic and clinical differences, including atrial fibrillation and aspirin and warfarin use, patients with a PFO were 4.6-fold more likely to have a stroke or TIA than were patients without a PFO, a statistically significant difference.
Additional analyses showed that the stroke and TIA rate remained significantly elevated in the PFO patients regardless of whether patients were on treatment with aspirin or on warfarin, and also regardless of whether or not they were older than age 65 or had a history of stroke or TIA, and regardless of whether they had a low or high CHA2D2-VASc score, Dr. DeSimone said. They saw no significant link between a PFO present and all-cause mortality.
The PFO-related difference in the incidence of stroke and TIA first became apparent about 1 year after device placement. The event curves continued to diverge more and more over time. Micro-emboli that originate on the device leads may pass through the PFO and into pulmonary circulation, causing increased pulmonary-artery pressures during the year after device placement. The increased right-sided pressure then favors a right-to-left shunt and increased embolization.
The stroke risk in this analysis may have underestimated the true risk because the methods used to find PFOs and stroke may not have been optimal.
Dr. DeSimone had no disclosures.
LOS ANGELES – Patients with a patent foramen ovale and an implanted defibrillator or pacemaker may be good candidates for targeted closure, based on a review of more than 6,000 patients.
During an average follow-up of nearly 5 years, patients with a PFO who received an implantable cardioverter defibrillator (ICD) or a permanent pacemaker were more than fourfold more likely to develop stroke or transient ischemic attack (TIA) compared with implanted device recipients who did not have a PFO, Dr. Christopher V. DeSimone said at the annual scientific sessions of the American Heart Association.
"We think that this is a high-risk population that might benefit from PFO closure," said Dr. DeSimone, an internal medicine physician at the Mayo Clinic in Rochester, Minn. He acknowledged the poor efficacy of PFO closure for stroke prevention in several recent randomized trials, but noted that patients with a PFO who receive an ICD or permanent pacemaker may constitute a special subgroup that stands to benefit from PFO closure. "If a patient has a right atrial or ventricular lead and a clot forms and sits there next to the PFO, they would be at high risk" for a stroke or TIA, he said in an interview. In fact, trials that have assessed the efficacy of PFO closure explicitly excluded patients with permanent pacemakers as well as many ICD recipients because of their substantially impaired left ventricular function, such as in the CLOSURE I trial (N. Engl. J. Med. 2012;366:991-9). "This needs to be studied prospectively," he added, noting that his study was limited by being retrospective.
Dr. DeSimone and his associates reviewed 6,086 patients who received an ICD or permanent pacemaker at the Mayo Clinic during January 2000 to October 2010. The group included 375 patients with PFOs. Average age of the patients was 67 years; nearly two-thirds were men. About 15% had a history of stroke or TIA, about 44% had atrial fibrillation, and their average CHA2D2-VASc score was 3.1.
During an average follow-up of 4.7 years, the incidence of stroke or TIA was 11% in the PFO patients and 2% in the patients without a PFO. In a multivariate analysis that controlled for baseline demographic and clinical differences, including atrial fibrillation and aspirin and warfarin use, patients with a PFO were 4.6-fold more likely to have a stroke or TIA than were patients without a PFO, a statistically significant difference.
Additional analyses showed that the stroke and TIA rate remained significantly elevated in the PFO patients regardless of whether patients were on treatment with aspirin or on warfarin, and also regardless of whether or not they were older than age 65 or had a history of stroke or TIA, and regardless of whether they had a low or high CHA2D2-VASc score, Dr. DeSimone said. They saw no significant link between a PFO present and all-cause mortality.
The PFO-related difference in the incidence of stroke and TIA first became apparent about 1 year after device placement. The event curves continued to diverge more and more over time. Micro-emboli that originate on the device leads may pass through the PFO and into pulmonary circulation, causing increased pulmonary-artery pressures during the year after device placement. The increased right-sided pressure then favors a right-to-left shunt and increased embolization.
The stroke risk in this analysis may have underestimated the true risk because the methods used to find PFOs and stroke may not have been optimal.
Dr. DeSimone had no disclosures.
LOS ANGELES – Patients with a patent foramen ovale and an implanted defibrillator or pacemaker may be good candidates for targeted closure, based on a review of more than 6,000 patients.
During an average follow-up of nearly 5 years, patients with a PFO who received an implantable cardioverter defibrillator (ICD) or a permanent pacemaker were more than fourfold more likely to develop stroke or transient ischemic attack (TIA) compared with implanted device recipients who did not have a PFO, Dr. Christopher V. DeSimone said at the annual scientific sessions of the American Heart Association.
"We think that this is a high-risk population that might benefit from PFO closure," said Dr. DeSimone, an internal medicine physician at the Mayo Clinic in Rochester, Minn. He acknowledged the poor efficacy of PFO closure for stroke prevention in several recent randomized trials, but noted that patients with a PFO who receive an ICD or permanent pacemaker may constitute a special subgroup that stands to benefit from PFO closure. "If a patient has a right atrial or ventricular lead and a clot forms and sits there next to the PFO, they would be at high risk" for a stroke or TIA, he said in an interview. In fact, trials that have assessed the efficacy of PFO closure explicitly excluded patients with permanent pacemakers as well as many ICD recipients because of their substantially impaired left ventricular function, such as in the CLOSURE I trial (N. Engl. J. Med. 2012;366:991-9). "This needs to be studied prospectively," he added, noting that his study was limited by being retrospective.
Dr. DeSimone and his associates reviewed 6,086 patients who received an ICD or permanent pacemaker at the Mayo Clinic during January 2000 to October 2010. The group included 375 patients with PFOs. Average age of the patients was 67 years; nearly two-thirds were men. About 15% had a history of stroke or TIA, about 44% had atrial fibrillation, and their average CHA2D2-VASc score was 3.1.
During an average follow-up of 4.7 years, the incidence of stroke or TIA was 11% in the PFO patients and 2% in the patients without a PFO. In a multivariate analysis that controlled for baseline demographic and clinical differences, including atrial fibrillation and aspirin and warfarin use, patients with a PFO were 4.6-fold more likely to have a stroke or TIA than were patients without a PFO, a statistically significant difference.
Additional analyses showed that the stroke and TIA rate remained significantly elevated in the PFO patients regardless of whether patients were on treatment with aspirin or on warfarin, and also regardless of whether or not they were older than age 65 or had a history of stroke or TIA, and regardless of whether they had a low or high CHA2D2-VASc score, Dr. DeSimone said. They saw no significant link between a PFO present and all-cause mortality.
The PFO-related difference in the incidence of stroke and TIA first became apparent about 1 year after device placement. The event curves continued to diverge more and more over time. Micro-emboli that originate on the device leads may pass through the PFO and into pulmonary circulation, causing increased pulmonary-artery pressures during the year after device placement. The increased right-sided pressure then favors a right-to-left shunt and increased embolization.
The stroke risk in this analysis may have underestimated the true risk because the methods used to find PFOs and stroke may not have been optimal.
Dr. DeSimone had no disclosures.
Major Finding: ICD or pacemaker recipients with a PFO had a 4.6-fold increased risk of stroke or TIA.
Data Source: A review of 6,086 patients at the Mayo Clinic.
Disclosures: Dr. DeSimone said that he had no disclosures.
Bacterial Contamination of Smart Phones
Mobile phones are now widely used. Healthcare workers, in particular, use them for rapid communication in many hospital settings. As mobile phones increase in popularity, a number of concerns have been raised, including noise and distraction in the clinical environment, confidentiality of patient information, and data security among others.[1]
Of the various concerns regarding mobile phone use in hospitals, one of the most important is that mobile phones may serve as vehicles for nosocomial transmission of micro‐organisms.[2, 3] One report showed that over 90% of healthcare workers' cell phones were contaminated with micro‐organisms, and 14.3% of cell phones were contaminated with bacteria that can cause nosocomial infection.[2]
Smart phones, which are rapidly flooding the mobile phone market, are useful in the hospital setting, as they could provide rapid access to medical information, quicker consultation and responding, feedback of results to the patient, and ongoing monitoring of chronic diseases (eg, asthma and diabetes).[4, 5, 6, 7, 8]
However, as most smart phones have wide, full, touch screens and are used more often by their owners than non‐smart phones are, bacterial contamination rates may be higher than those of non‐smart phones. The aim of this study was to compare the contamination rates by bacteria with pathogenic potential in smart phones versus non‐smart phones.
MATERIALS AND METHODS
Study Design and Participants
This cross‐sectional study was conducted from March 1, 2011 to June 30, 2011, in 3 teaching hospitals affiliated with Seoul National University School of Medicine, namely Seoul National University Hospital, Bundang Seoul National University Hospital, and Seoul National University Boramae Medical Center. Hospital staff working in general wards as well as in intensive care units of the 3 hospitals were invited to participate in this study. The study protocol was approved by the institutional review board of each of the 3 participating hospitals. Informed consent was obtained from all participants.
Questionnaire
We designed a questionnaire inquiring about demographics (age, gender, occupation) as well as behavior regarding cell phone use (type of cell phone, frequency and reasons for use, cleaning of cell phones).
Bacterial Culture, Identification, and Drug Susceptibility Testing
Both the anterior and posterior surfaces of each participant's mobile phone were touched onto blood agar plates. The sampled culture plates were subsequently incubated aerobically at 36C for 48 hours. To identify cultivated micro‐organisms and for the assessment of antibiotic susceptibility, VITEK2 (bioMrieux, Inc., Durham, NC) systems were used.
Classification of Isolated Micro‐organisms
We classified the micro‐organisms isolated from healthcare workers' mobile phones as bacteria with pathogenic potential (probable pathogens) or nonpathogens.[4, 9] Among probable pathogenic micro‐organisms, representative drug‐resistant strains such as methicillin‐resistant Staphylococcus aureus (MRSA), vancomycin‐resistant Enterococcus (VRE), and imipenem‐resistant Acinetobacter baumannii (IRAB) were categorized as drug‐resistant pathogens.
Classification of Smart Phones Versus Non‐Smart Phones
Mobile phones that ran complete mobile operating systems and software that provided a standardized interface and a platform for application developers, were classified as smart phones.[10] All others were classified as non‐smart phones.
Statistical Analysis
The participants' clinical variables were analyzed using descriptive statistics. The results are expressed as meanstandard deviation or median value with range. Variables were compared between the smart phone and non‐smart phone users. Categorical variables were compared by [2] analysis, and continuous variables were compared using Student t test or the Mann‐Whitney test. Variables with P0.20 after univariate analysis or clinically significant variables were subjected to multiple logistic regression to determine the risk factors for contamination of cell phones with potentially pathogenic bacteria. For all analyses, P values 0.05 were considered significant. Homer‐Lemeshow goodness of fit (GOF) test was performed to confirm the fitness of the final model. The Statistical Package for the Social Sciences version 17.0 (IBM SPSS, Armonk, NY) was used for all statistical analysis.
RESULTS
Participants and Their Behaviors Regarding Cell Phone Use
In total, 203 healthcare workers participated in this study; 80 (39.4%) were physicians, 106 (52.2%) were nurses, and 17 (8.4%) were assistants. The median age of the participants was 29 years, 43 (21.2%) were males, 115 (56.7%) participants used smart phones, and 88 (43.3%) were non‐smart phone users (Table 1).
| Smart Phone Users (N=115) | Non‐Smart Phone Users (N=88) | P Valuea | |
|---|---|---|---|
| |||
| Age, median (range), y | 28 (2048) | 29 (1952) | 0.03 |
| Gender, female | 92 (80.0%) | 68 (77.3%) | 0.64 |
| ICU workers | 78 (67.8%) | 57 (64.8%) | 0.65 |
| Occupation | 0.93 | ||
| Physicians | 45 (39.1%) | 35 (39.8%) | |
| Nurses | 63 (54.8%) | 43 (48.9%) | |
| Others | 7 (6.1%) | 10 (11.4%) | |
| Direct contact with patients | 110 (95.7%) | 84 (95.5%) | 0.95 |
| Using phones during work hours | 53 (46.1%) | 45 (51.1%) | 0.48 |
| Frequency of using phones during working | 0.46 | ||
| 13 | 8 (7.0%) | 10 (11.4%) | |
| 46 | 11 (9.6%) | 6 (6.8%) | |
| 79 | 8 (7.0%) | 1 (1.1%) | |
| Over 10 times | 26 (22.6%) | 28 (31.8%) | |
| None | 62 (53.9%) | 43 (48.9%) | |
| Reason of using phones | 0.04 | ||
| Calling | 30 (26.1%) | 42 (47.7%) | |
| Mail check or searching information | 3 (2.6%) | 0 | |
| Both reasons | 20 (17.4%) | 3 (3.4%) | |
| None | 62 (53.9%) | 43 (48.9%) | |
| Routine cleaning of phones | 15 (13.2%) | 11 (12.8%) | 0.94 |
| Frequency of cleaning hands (times/day) | 0.21 | ||
| 03 | 1 (0.9%) | 4 (4.5%) | |
| 46 | 18 (15.7%) | 14 (15.9%) | |
| 710 | 13 (11.3%) | 13 (14.8%) | |
| Over 10 | 83 (72.2%) | 57 (64.8%) | |
| Methods of cleaning hands | 0.72 | ||
| Washing with soaps | 48 (41.7%) | 34 (38.6%) | |
| Disinfectant | 42 (36.5%) | 33 (37.5%) | |
| Both | 25 (21.8%) | 21 (23.8%) | |
Smart phone users were slightly younger than non‐smart phone users. The distribution of occupations did not differ between the two groups. The frequency of use, reasons for using cell phones, the proportion of participants who routinely cleaned their phone, and the frequency of hand washing were also similar (Table 1).
Bacteria Isolated From Cell Phones
Bacteria were isolated from all 203 mobile phones; 3 or more different types of bacteria were isolated from 155 (76.4%) phones, 2 types from 39 (19.2%) phones, and 1 type from 9 (4.4%) phones. The most commonly cultured micro‐organism was coagulase‐negative Staphylococcus, which was isolated from 194 (95.6%) cell phones. The isolation of Gram‐positive bacilli and Micrococcus species was also frequent.
Probable pathogenic bacteria were isolated from 58 (28.6%) mobile phones. Among probable pathogens, Staphylococcus aureus (S. aureus) was the most commonly isolated. Of the 50 mobile phones that were contaminated with S. aureus, 8 were contaminated with a methicillin‐resistant strain. Five (2.4%) phones yielded Acinetobacter baumannii (Table 2).
| Organisms | Total, N=203 | No. of Drug Resistant Strains |
|---|---|---|
| Probable pathogen | ||
| Gram‐positive bacteria | ||
| Staphylococcus aureus | 50 (24.6%) | 8 (16%) |
| Streptococcus agalactiae | 1 (0.5%) | 0 |
| Enterococcus faecium | 1 (0.5%) | 1 (100%) |
| Gram‐negative bacteria | ||
| Acinetobacter baumannii | 5 (2.4%) | 1 (20%) |
| Pseudomonas aeruginosa | 1 (0.5%) | 0 |
| Enterobacter cloacae | 2 (1.0%) | 0 |
Although all mobile phones were contaminated with bacteria, probable pathogens were isolated more often from smart phones (34.8% vs 20.5% of non‐smart phones, P=0.03). The total colony count of probable pathogens from smart phones was also higher (average, 5.5 vs 5.0 from non‐smart phones, P=0.01). The isolation rate of drug‐resistant pathogens appeared to be higher from smart phones (7.0% vs 2.3% from non‐smart phones), but this difference did not reach statistical significance (P=0.19).
Risk Factors for Contamination With Probable Pathogens
In the final model constructed to determine the risk factors for contamination with probable pathogenic bacteria, data regarding cell phone users' age, gender, occupation (ie, physician or not), duration of working in the same place, daily work hours, whether the phone was a smart phone, and frequency of cell phone use during working hours were included. Among these factors, only the phone's being a smart phone was found to be a risk factor for contamination by bacteria with pathogenic potential (adjusted odds ratio (OR), 4.02; 95% CI, 1.43‐11.31; P=0.01). The fitness of this model was confirmed with the Hosmer‐Lemeshow GOF test (P=0.94). Using the cell phone more than 10 times during working hours appeared to be associated with pathogen contamination; however, this correlation failed to reach statistical significance (OR, 2.9; 95% CI, 0.9‐9.3; P=0.07).
DISCUSSION
Our study showed that smart phones were more frequently contaminated with bacteria than were non‐smart phones. In addition, total colony count of probable pathogens from smart phones was also higher. The colony count as well as contamination rate of pathogens are clinically relevant, because both factors can attribute to increased transmission of pathogens.[11]
Previous studies have attempted to identify user risk factors associated with bacterial contamination of cell phones.[12, 13, 14] Many variables, including gender, frequency of use, type of phone, work time, and the medical specialty of the user were considered; however, none of these factors was associated with an increased risk of bacterial contamination.[2, 14, 15]
In our study, none of the above‐mentioned factors was associated with contamination of cell phones by potentially pathogenic bacteria. Smart phones were the sole predictor of contamination by such bacteria. The reason that smart phones were more frequently contaminated with bacteria with pathogenic potential than were non‐smart phones is not clear. We propose two hypotheses to explain this observation. First, smart phones generally have wide screens, whereas non‐smart phones have relatively small screens with keypads. Larger screens may afford more opportunity for contamination by micro‐organisms. The mean size of a monitor in the smart phone group was 6633.2 340.1 cm2 and 5729.4564.7 cm2 in the non‐smart phone group (P0.01). However, in a multivariate model including size with other variables above, the smart phone remained a significant risk factor for the pathogen contamination (odds ratio [OR], 4.17; 95% CI, 1.06‐16.33; P=0.04). Cell phones are manufactured in a standardized form and the size cannot be changed or controlled. Therefore, we did not include the size in the final model of logistic regression in the main result. Our second explanation is in regard to the pattern of use of smart phones. Considering a single use, smart phones are used for longer periods and require a higher number of finger touches compared with non‐smart phones. The intensive use of phones with large screens could facilitate contamination of smart phones by pathogens from the healthcare workers' fingers or palms.
A recent study showed that cleaning cell phones on a daily basis decreased contamination rates. However, it did not decrease contamination by potentially pathogenic bacteria.[12] The role of the hospital environment as a reservoir of nosocomial pathogens and the effect of sanitization on decreasing clinical infection are still controversial.[16, 17, 18, 19] Thus, further studies are needed to recommend routine cell phone sanitizing and to declare that it is relevant in terms of reduction of hospital‐acquired infections potentially associated with the mobile phones of healthcare workers.
Our study is subject to limitation. Lack of association between hand washing and pathogen contamination might be a result of false reporting on hand washing behavior as well as the small number of participants. The bacterial contamination rate of the folding type of non‐smart phones may have been underestimated, as their keypads could not contact agar plates because they would not opened flatly (we touched the exterior surface of the folding type phones, which did not harbor the keypad, to the agar plate). However, given that folding phones are usually stored in their folded position, bacteria on the outside of the phones are likely more relevant than those within keypads insofar as transmission is concerned.
In summary, our data showed that over one‐fourth of the mobile phones examined in this study were found to harbor potentially pathogenic micro‐organisms. In particular, smart phones of healthcare workers were more frequently contaminated with potentially pathogenic bacteria than were non‐smart phones even after adjusting for the phone size. Preventive measures to minimize the possibility of bacterial transmission via cell phones should be devised.
Disclosure
This study was funded by grant 04‐2011‐1020 from the Seoul National University College of Medicine Research Fund (Seoul, South Korea). The sponsor of the study had no role in the tudy design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. The authors declare that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.
- , , , et al. Evidence‐based policy? The use of mobile phones in hospital. J Public Health (Oxf). 2006;28:299–303.
- , , , , . Is your phone bugged? The incidence of bacteria known to cause nosocomial infection on healthcare workers' mobile phones. J Hosp Infect. 2006;62:123–125.
- , , , , . Bacterial contamination of mobile communication devices in the operative environment. J Hosp Infect. 2007;66:397–398.
- , , , . Review of mobile communication devices as potential reservoirs of nosocomial pathogens. J Hosp Infect. 2009;71:295–300.
- , , . Use of SMS text messaging to improve outpatient attendance. Med J Aust. 2005;183:366–368.
- , , , et al. The use of text messaging to improve attendance in primary care: a randomized controlled trial. Fam Pract. 2006;23:699–705.
- , , , . Mobile phone text messaging in the management of diabetes. J Telemed Telecare. 2004;10:282–285.
- , , , , . Mobile phone text messaging can help young people manage asthma. BMJ. 2002;325:600.
- , , , et al. Use of cellular telephones and transmission of pathogens by medical staff in New York and Israel. Infect Control Hosp Epidemiol. 2007;28:500–503.
- Feature phone. Phone Scoop Web site. Available at: http://www.phonescoop.com/glossary/term.php?gid=310. Accessed June 22, 2011.
- , , . Comparison of two possible routes of pathogen contamination of spinach leaves in a hydroponic cultivation system. J Food Prot 2011;74:1536–1542.
- , , , et al. Use of mobile phones by medical staff at Queen Elizabeth Hospital, Barbados: evidence for both benefit and harm. J Hosp Infect. 2008;70:160–165.
- , , , . Pathogenic bacteria on personal pagers. Am J Infect Control. 2000;28:387–388.
- , , , , , . Bacterial contamination of health care workers' pagers and the efficacy of various disinfecting agents. Pediatr Infect Dis J. 2006;25: 1074–1075.
- , , . Preventing transmission of multidrug‐resistant bacteria in health care settings: a tale of 2 guidelines. Clin Infect Dis. 2006;42:828–835.
- . Environmental contamination makes an important contribution to hospital infection. J Hosp Infect. 2007;65(suppl 2):50–54.
- , , , . Widespread environmental contamination associated with patients with diarrhea and methicillin‐resistant Staphylococcus aureus colonization of the gastrointestinal tract. Infect Control Hosp Epidemiol. 2007;28:1142–1147.
- , , , , . Computer keyboards and faucet handles as reservoirs of nosocomial pathogens in the intensive care unit. Am J Infect Control. 2000;28:465–471.
- , , , , , . Routine disinfection of patients' environmental surfaces. Myth or reality? J Hosp Infect. 1999;42:113–117.
Mobile phones are now widely used. Healthcare workers, in particular, use them for rapid communication in many hospital settings. As mobile phones increase in popularity, a number of concerns have been raised, including noise and distraction in the clinical environment, confidentiality of patient information, and data security among others.[1]
Of the various concerns regarding mobile phone use in hospitals, one of the most important is that mobile phones may serve as vehicles for nosocomial transmission of micro‐organisms.[2, 3] One report showed that over 90% of healthcare workers' cell phones were contaminated with micro‐organisms, and 14.3% of cell phones were contaminated with bacteria that can cause nosocomial infection.[2]
Smart phones, which are rapidly flooding the mobile phone market, are useful in the hospital setting, as they could provide rapid access to medical information, quicker consultation and responding, feedback of results to the patient, and ongoing monitoring of chronic diseases (eg, asthma and diabetes).[4, 5, 6, 7, 8]
However, as most smart phones have wide, full, touch screens and are used more often by their owners than non‐smart phones are, bacterial contamination rates may be higher than those of non‐smart phones. The aim of this study was to compare the contamination rates by bacteria with pathogenic potential in smart phones versus non‐smart phones.
MATERIALS AND METHODS
Study Design and Participants
This cross‐sectional study was conducted from March 1, 2011 to June 30, 2011, in 3 teaching hospitals affiliated with Seoul National University School of Medicine, namely Seoul National University Hospital, Bundang Seoul National University Hospital, and Seoul National University Boramae Medical Center. Hospital staff working in general wards as well as in intensive care units of the 3 hospitals were invited to participate in this study. The study protocol was approved by the institutional review board of each of the 3 participating hospitals. Informed consent was obtained from all participants.
Questionnaire
We designed a questionnaire inquiring about demographics (age, gender, occupation) as well as behavior regarding cell phone use (type of cell phone, frequency and reasons for use, cleaning of cell phones).
Bacterial Culture, Identification, and Drug Susceptibility Testing
Both the anterior and posterior surfaces of each participant's mobile phone were touched onto blood agar plates. The sampled culture plates were subsequently incubated aerobically at 36C for 48 hours. To identify cultivated micro‐organisms and for the assessment of antibiotic susceptibility, VITEK2 (bioMrieux, Inc., Durham, NC) systems were used.
Classification of Isolated Micro‐organisms
We classified the micro‐organisms isolated from healthcare workers' mobile phones as bacteria with pathogenic potential (probable pathogens) or nonpathogens.[4, 9] Among probable pathogenic micro‐organisms, representative drug‐resistant strains such as methicillin‐resistant Staphylococcus aureus (MRSA), vancomycin‐resistant Enterococcus (VRE), and imipenem‐resistant Acinetobacter baumannii (IRAB) were categorized as drug‐resistant pathogens.
Classification of Smart Phones Versus Non‐Smart Phones
Mobile phones that ran complete mobile operating systems and software that provided a standardized interface and a platform for application developers, were classified as smart phones.[10] All others were classified as non‐smart phones.
Statistical Analysis
The participants' clinical variables were analyzed using descriptive statistics. The results are expressed as meanstandard deviation or median value with range. Variables were compared between the smart phone and non‐smart phone users. Categorical variables were compared by [2] analysis, and continuous variables were compared using Student t test or the Mann‐Whitney test. Variables with P0.20 after univariate analysis or clinically significant variables were subjected to multiple logistic regression to determine the risk factors for contamination of cell phones with potentially pathogenic bacteria. For all analyses, P values 0.05 were considered significant. Homer‐Lemeshow goodness of fit (GOF) test was performed to confirm the fitness of the final model. The Statistical Package for the Social Sciences version 17.0 (IBM SPSS, Armonk, NY) was used for all statistical analysis.
RESULTS
Participants and Their Behaviors Regarding Cell Phone Use
In total, 203 healthcare workers participated in this study; 80 (39.4%) were physicians, 106 (52.2%) were nurses, and 17 (8.4%) were assistants. The median age of the participants was 29 years, 43 (21.2%) were males, 115 (56.7%) participants used smart phones, and 88 (43.3%) were non‐smart phone users (Table 1).
| Smart Phone Users (N=115) | Non‐Smart Phone Users (N=88) | P Valuea | |
|---|---|---|---|
| |||
| Age, median (range), y | 28 (2048) | 29 (1952) | 0.03 |
| Gender, female | 92 (80.0%) | 68 (77.3%) | 0.64 |
| ICU workers | 78 (67.8%) | 57 (64.8%) | 0.65 |
| Occupation | 0.93 | ||
| Physicians | 45 (39.1%) | 35 (39.8%) | |
| Nurses | 63 (54.8%) | 43 (48.9%) | |
| Others | 7 (6.1%) | 10 (11.4%) | |
| Direct contact with patients | 110 (95.7%) | 84 (95.5%) | 0.95 |
| Using phones during work hours | 53 (46.1%) | 45 (51.1%) | 0.48 |
| Frequency of using phones during working | 0.46 | ||
| 13 | 8 (7.0%) | 10 (11.4%) | |
| 46 | 11 (9.6%) | 6 (6.8%) | |
| 79 | 8 (7.0%) | 1 (1.1%) | |
| Over 10 times | 26 (22.6%) | 28 (31.8%) | |
| None | 62 (53.9%) | 43 (48.9%) | |
| Reason of using phones | 0.04 | ||
| Calling | 30 (26.1%) | 42 (47.7%) | |
| Mail check or searching information | 3 (2.6%) | 0 | |
| Both reasons | 20 (17.4%) | 3 (3.4%) | |
| None | 62 (53.9%) | 43 (48.9%) | |
| Routine cleaning of phones | 15 (13.2%) | 11 (12.8%) | 0.94 |
| Frequency of cleaning hands (times/day) | 0.21 | ||
| 03 | 1 (0.9%) | 4 (4.5%) | |
| 46 | 18 (15.7%) | 14 (15.9%) | |
| 710 | 13 (11.3%) | 13 (14.8%) | |
| Over 10 | 83 (72.2%) | 57 (64.8%) | |
| Methods of cleaning hands | 0.72 | ||
| Washing with soaps | 48 (41.7%) | 34 (38.6%) | |
| Disinfectant | 42 (36.5%) | 33 (37.5%) | |
| Both | 25 (21.8%) | 21 (23.8%) | |
Smart phone users were slightly younger than non‐smart phone users. The distribution of occupations did not differ between the two groups. The frequency of use, reasons for using cell phones, the proportion of participants who routinely cleaned their phone, and the frequency of hand washing were also similar (Table 1).
Bacteria Isolated From Cell Phones
Bacteria were isolated from all 203 mobile phones; 3 or more different types of bacteria were isolated from 155 (76.4%) phones, 2 types from 39 (19.2%) phones, and 1 type from 9 (4.4%) phones. The most commonly cultured micro‐organism was coagulase‐negative Staphylococcus, which was isolated from 194 (95.6%) cell phones. The isolation of Gram‐positive bacilli and Micrococcus species was also frequent.
Probable pathogenic bacteria were isolated from 58 (28.6%) mobile phones. Among probable pathogens, Staphylococcus aureus (S. aureus) was the most commonly isolated. Of the 50 mobile phones that were contaminated with S. aureus, 8 were contaminated with a methicillin‐resistant strain. Five (2.4%) phones yielded Acinetobacter baumannii (Table 2).
| Organisms | Total, N=203 | No. of Drug Resistant Strains |
|---|---|---|
| Probable pathogen | ||
| Gram‐positive bacteria | ||
| Staphylococcus aureus | 50 (24.6%) | 8 (16%) |
| Streptococcus agalactiae | 1 (0.5%) | 0 |
| Enterococcus faecium | 1 (0.5%) | 1 (100%) |
| Gram‐negative bacteria | ||
| Acinetobacter baumannii | 5 (2.4%) | 1 (20%) |
| Pseudomonas aeruginosa | 1 (0.5%) | 0 |
| Enterobacter cloacae | 2 (1.0%) | 0 |
Although all mobile phones were contaminated with bacteria, probable pathogens were isolated more often from smart phones (34.8% vs 20.5% of non‐smart phones, P=0.03). The total colony count of probable pathogens from smart phones was also higher (average, 5.5 vs 5.0 from non‐smart phones, P=0.01). The isolation rate of drug‐resistant pathogens appeared to be higher from smart phones (7.0% vs 2.3% from non‐smart phones), but this difference did not reach statistical significance (P=0.19).
Risk Factors for Contamination With Probable Pathogens
In the final model constructed to determine the risk factors for contamination with probable pathogenic bacteria, data regarding cell phone users' age, gender, occupation (ie, physician or not), duration of working in the same place, daily work hours, whether the phone was a smart phone, and frequency of cell phone use during working hours were included. Among these factors, only the phone's being a smart phone was found to be a risk factor for contamination by bacteria with pathogenic potential (adjusted odds ratio (OR), 4.02; 95% CI, 1.43‐11.31; P=0.01). The fitness of this model was confirmed with the Hosmer‐Lemeshow GOF test (P=0.94). Using the cell phone more than 10 times during working hours appeared to be associated with pathogen contamination; however, this correlation failed to reach statistical significance (OR, 2.9; 95% CI, 0.9‐9.3; P=0.07).
DISCUSSION
Our study showed that smart phones were more frequently contaminated with bacteria than were non‐smart phones. In addition, total colony count of probable pathogens from smart phones was also higher. The colony count as well as contamination rate of pathogens are clinically relevant, because both factors can attribute to increased transmission of pathogens.[11]
Previous studies have attempted to identify user risk factors associated with bacterial contamination of cell phones.[12, 13, 14] Many variables, including gender, frequency of use, type of phone, work time, and the medical specialty of the user were considered; however, none of these factors was associated with an increased risk of bacterial contamination.[2, 14, 15]
In our study, none of the above‐mentioned factors was associated with contamination of cell phones by potentially pathogenic bacteria. Smart phones were the sole predictor of contamination by such bacteria. The reason that smart phones were more frequently contaminated with bacteria with pathogenic potential than were non‐smart phones is not clear. We propose two hypotheses to explain this observation. First, smart phones generally have wide screens, whereas non‐smart phones have relatively small screens with keypads. Larger screens may afford more opportunity for contamination by micro‐organisms. The mean size of a monitor in the smart phone group was 6633.2 340.1 cm2 and 5729.4564.7 cm2 in the non‐smart phone group (P0.01). However, in a multivariate model including size with other variables above, the smart phone remained a significant risk factor for the pathogen contamination (odds ratio [OR], 4.17; 95% CI, 1.06‐16.33; P=0.04). Cell phones are manufactured in a standardized form and the size cannot be changed or controlled. Therefore, we did not include the size in the final model of logistic regression in the main result. Our second explanation is in regard to the pattern of use of smart phones. Considering a single use, smart phones are used for longer periods and require a higher number of finger touches compared with non‐smart phones. The intensive use of phones with large screens could facilitate contamination of smart phones by pathogens from the healthcare workers' fingers or palms.
A recent study showed that cleaning cell phones on a daily basis decreased contamination rates. However, it did not decrease contamination by potentially pathogenic bacteria.[12] The role of the hospital environment as a reservoir of nosocomial pathogens and the effect of sanitization on decreasing clinical infection are still controversial.[16, 17, 18, 19] Thus, further studies are needed to recommend routine cell phone sanitizing and to declare that it is relevant in terms of reduction of hospital‐acquired infections potentially associated with the mobile phones of healthcare workers.
Our study is subject to limitation. Lack of association between hand washing and pathogen contamination might be a result of false reporting on hand washing behavior as well as the small number of participants. The bacterial contamination rate of the folding type of non‐smart phones may have been underestimated, as their keypads could not contact agar plates because they would not opened flatly (we touched the exterior surface of the folding type phones, which did not harbor the keypad, to the agar plate). However, given that folding phones are usually stored in their folded position, bacteria on the outside of the phones are likely more relevant than those within keypads insofar as transmission is concerned.
In summary, our data showed that over one‐fourth of the mobile phones examined in this study were found to harbor potentially pathogenic micro‐organisms. In particular, smart phones of healthcare workers were more frequently contaminated with potentially pathogenic bacteria than were non‐smart phones even after adjusting for the phone size. Preventive measures to minimize the possibility of bacterial transmission via cell phones should be devised.
Disclosure
This study was funded by grant 04‐2011‐1020 from the Seoul National University College of Medicine Research Fund (Seoul, South Korea). The sponsor of the study had no role in the tudy design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. The authors declare that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.
Mobile phones are now widely used. Healthcare workers, in particular, use them for rapid communication in many hospital settings. As mobile phones increase in popularity, a number of concerns have been raised, including noise and distraction in the clinical environment, confidentiality of patient information, and data security among others.[1]
Of the various concerns regarding mobile phone use in hospitals, one of the most important is that mobile phones may serve as vehicles for nosocomial transmission of micro‐organisms.[2, 3] One report showed that over 90% of healthcare workers' cell phones were contaminated with micro‐organisms, and 14.3% of cell phones were contaminated with bacteria that can cause nosocomial infection.[2]
Smart phones, which are rapidly flooding the mobile phone market, are useful in the hospital setting, as they could provide rapid access to medical information, quicker consultation and responding, feedback of results to the patient, and ongoing monitoring of chronic diseases (eg, asthma and diabetes).[4, 5, 6, 7, 8]
However, as most smart phones have wide, full, touch screens and are used more often by their owners than non‐smart phones are, bacterial contamination rates may be higher than those of non‐smart phones. The aim of this study was to compare the contamination rates by bacteria with pathogenic potential in smart phones versus non‐smart phones.
MATERIALS AND METHODS
Study Design and Participants
This cross‐sectional study was conducted from March 1, 2011 to June 30, 2011, in 3 teaching hospitals affiliated with Seoul National University School of Medicine, namely Seoul National University Hospital, Bundang Seoul National University Hospital, and Seoul National University Boramae Medical Center. Hospital staff working in general wards as well as in intensive care units of the 3 hospitals were invited to participate in this study. The study protocol was approved by the institutional review board of each of the 3 participating hospitals. Informed consent was obtained from all participants.
Questionnaire
We designed a questionnaire inquiring about demographics (age, gender, occupation) as well as behavior regarding cell phone use (type of cell phone, frequency and reasons for use, cleaning of cell phones).
Bacterial Culture, Identification, and Drug Susceptibility Testing
Both the anterior and posterior surfaces of each participant's mobile phone were touched onto blood agar plates. The sampled culture plates were subsequently incubated aerobically at 36C for 48 hours. To identify cultivated micro‐organisms and for the assessment of antibiotic susceptibility, VITEK2 (bioMrieux, Inc., Durham, NC) systems were used.
Classification of Isolated Micro‐organisms
We classified the micro‐organisms isolated from healthcare workers' mobile phones as bacteria with pathogenic potential (probable pathogens) or nonpathogens.[4, 9] Among probable pathogenic micro‐organisms, representative drug‐resistant strains such as methicillin‐resistant Staphylococcus aureus (MRSA), vancomycin‐resistant Enterococcus (VRE), and imipenem‐resistant Acinetobacter baumannii (IRAB) were categorized as drug‐resistant pathogens.
Classification of Smart Phones Versus Non‐Smart Phones
Mobile phones that ran complete mobile operating systems and software that provided a standardized interface and a platform for application developers, were classified as smart phones.[10] All others were classified as non‐smart phones.
Statistical Analysis
The participants' clinical variables were analyzed using descriptive statistics. The results are expressed as meanstandard deviation or median value with range. Variables were compared between the smart phone and non‐smart phone users. Categorical variables were compared by [2] analysis, and continuous variables were compared using Student t test or the Mann‐Whitney test. Variables with P0.20 after univariate analysis or clinically significant variables were subjected to multiple logistic regression to determine the risk factors for contamination of cell phones with potentially pathogenic bacteria. For all analyses, P values 0.05 were considered significant. Homer‐Lemeshow goodness of fit (GOF) test was performed to confirm the fitness of the final model. The Statistical Package for the Social Sciences version 17.0 (IBM SPSS, Armonk, NY) was used for all statistical analysis.
RESULTS
Participants and Their Behaviors Regarding Cell Phone Use
In total, 203 healthcare workers participated in this study; 80 (39.4%) were physicians, 106 (52.2%) were nurses, and 17 (8.4%) were assistants. The median age of the participants was 29 years, 43 (21.2%) were males, 115 (56.7%) participants used smart phones, and 88 (43.3%) were non‐smart phone users (Table 1).
| Smart Phone Users (N=115) | Non‐Smart Phone Users (N=88) | P Valuea | |
|---|---|---|---|
| |||
| Age, median (range), y | 28 (2048) | 29 (1952) | 0.03 |
| Gender, female | 92 (80.0%) | 68 (77.3%) | 0.64 |
| ICU workers | 78 (67.8%) | 57 (64.8%) | 0.65 |
| Occupation | 0.93 | ||
| Physicians | 45 (39.1%) | 35 (39.8%) | |
| Nurses | 63 (54.8%) | 43 (48.9%) | |
| Others | 7 (6.1%) | 10 (11.4%) | |
| Direct contact with patients | 110 (95.7%) | 84 (95.5%) | 0.95 |
| Using phones during work hours | 53 (46.1%) | 45 (51.1%) | 0.48 |
| Frequency of using phones during working | 0.46 | ||
| 13 | 8 (7.0%) | 10 (11.4%) | |
| 46 | 11 (9.6%) | 6 (6.8%) | |
| 79 | 8 (7.0%) | 1 (1.1%) | |
| Over 10 times | 26 (22.6%) | 28 (31.8%) | |
| None | 62 (53.9%) | 43 (48.9%) | |
| Reason of using phones | 0.04 | ||
| Calling | 30 (26.1%) | 42 (47.7%) | |
| Mail check or searching information | 3 (2.6%) | 0 | |
| Both reasons | 20 (17.4%) | 3 (3.4%) | |
| None | 62 (53.9%) | 43 (48.9%) | |
| Routine cleaning of phones | 15 (13.2%) | 11 (12.8%) | 0.94 |
| Frequency of cleaning hands (times/day) | 0.21 | ||
| 03 | 1 (0.9%) | 4 (4.5%) | |
| 46 | 18 (15.7%) | 14 (15.9%) | |
| 710 | 13 (11.3%) | 13 (14.8%) | |
| Over 10 | 83 (72.2%) | 57 (64.8%) | |
| Methods of cleaning hands | 0.72 | ||
| Washing with soaps | 48 (41.7%) | 34 (38.6%) | |
| Disinfectant | 42 (36.5%) | 33 (37.5%) | |
| Both | 25 (21.8%) | 21 (23.8%) | |
Smart phone users were slightly younger than non‐smart phone users. The distribution of occupations did not differ between the two groups. The frequency of use, reasons for using cell phones, the proportion of participants who routinely cleaned their phone, and the frequency of hand washing were also similar (Table 1).
Bacteria Isolated From Cell Phones
Bacteria were isolated from all 203 mobile phones; 3 or more different types of bacteria were isolated from 155 (76.4%) phones, 2 types from 39 (19.2%) phones, and 1 type from 9 (4.4%) phones. The most commonly cultured micro‐organism was coagulase‐negative Staphylococcus, which was isolated from 194 (95.6%) cell phones. The isolation of Gram‐positive bacilli and Micrococcus species was also frequent.
Probable pathogenic bacteria were isolated from 58 (28.6%) mobile phones. Among probable pathogens, Staphylococcus aureus (S. aureus) was the most commonly isolated. Of the 50 mobile phones that were contaminated with S. aureus, 8 were contaminated with a methicillin‐resistant strain. Five (2.4%) phones yielded Acinetobacter baumannii (Table 2).
| Organisms | Total, N=203 | No. of Drug Resistant Strains |
|---|---|---|
| Probable pathogen | ||
| Gram‐positive bacteria | ||
| Staphylococcus aureus | 50 (24.6%) | 8 (16%) |
| Streptococcus agalactiae | 1 (0.5%) | 0 |
| Enterococcus faecium | 1 (0.5%) | 1 (100%) |
| Gram‐negative bacteria | ||
| Acinetobacter baumannii | 5 (2.4%) | 1 (20%) |
| Pseudomonas aeruginosa | 1 (0.5%) | 0 |
| Enterobacter cloacae | 2 (1.0%) | 0 |
Although all mobile phones were contaminated with bacteria, probable pathogens were isolated more often from smart phones (34.8% vs 20.5% of non‐smart phones, P=0.03). The total colony count of probable pathogens from smart phones was also higher (average, 5.5 vs 5.0 from non‐smart phones, P=0.01). The isolation rate of drug‐resistant pathogens appeared to be higher from smart phones (7.0% vs 2.3% from non‐smart phones), but this difference did not reach statistical significance (P=0.19).
Risk Factors for Contamination With Probable Pathogens
In the final model constructed to determine the risk factors for contamination with probable pathogenic bacteria, data regarding cell phone users' age, gender, occupation (ie, physician or not), duration of working in the same place, daily work hours, whether the phone was a smart phone, and frequency of cell phone use during working hours were included. Among these factors, only the phone's being a smart phone was found to be a risk factor for contamination by bacteria with pathogenic potential (adjusted odds ratio (OR), 4.02; 95% CI, 1.43‐11.31; P=0.01). The fitness of this model was confirmed with the Hosmer‐Lemeshow GOF test (P=0.94). Using the cell phone more than 10 times during working hours appeared to be associated with pathogen contamination; however, this correlation failed to reach statistical significance (OR, 2.9; 95% CI, 0.9‐9.3; P=0.07).
DISCUSSION
Our study showed that smart phones were more frequently contaminated with bacteria than were non‐smart phones. In addition, total colony count of probable pathogens from smart phones was also higher. The colony count as well as contamination rate of pathogens are clinically relevant, because both factors can attribute to increased transmission of pathogens.[11]
Previous studies have attempted to identify user risk factors associated with bacterial contamination of cell phones.[12, 13, 14] Many variables, including gender, frequency of use, type of phone, work time, and the medical specialty of the user were considered; however, none of these factors was associated with an increased risk of bacterial contamination.[2, 14, 15]
In our study, none of the above‐mentioned factors was associated with contamination of cell phones by potentially pathogenic bacteria. Smart phones were the sole predictor of contamination by such bacteria. The reason that smart phones were more frequently contaminated with bacteria with pathogenic potential than were non‐smart phones is not clear. We propose two hypotheses to explain this observation. First, smart phones generally have wide screens, whereas non‐smart phones have relatively small screens with keypads. Larger screens may afford more opportunity for contamination by micro‐organisms. The mean size of a monitor in the smart phone group was 6633.2 340.1 cm2 and 5729.4564.7 cm2 in the non‐smart phone group (P0.01). However, in a multivariate model including size with other variables above, the smart phone remained a significant risk factor for the pathogen contamination (odds ratio [OR], 4.17; 95% CI, 1.06‐16.33; P=0.04). Cell phones are manufactured in a standardized form and the size cannot be changed or controlled. Therefore, we did not include the size in the final model of logistic regression in the main result. Our second explanation is in regard to the pattern of use of smart phones. Considering a single use, smart phones are used for longer periods and require a higher number of finger touches compared with non‐smart phones. The intensive use of phones with large screens could facilitate contamination of smart phones by pathogens from the healthcare workers' fingers or palms.
A recent study showed that cleaning cell phones on a daily basis decreased contamination rates. However, it did not decrease contamination by potentially pathogenic bacteria.[12] The role of the hospital environment as a reservoir of nosocomial pathogens and the effect of sanitization on decreasing clinical infection are still controversial.[16, 17, 18, 19] Thus, further studies are needed to recommend routine cell phone sanitizing and to declare that it is relevant in terms of reduction of hospital‐acquired infections potentially associated with the mobile phones of healthcare workers.
Our study is subject to limitation. Lack of association between hand washing and pathogen contamination might be a result of false reporting on hand washing behavior as well as the small number of participants. The bacterial contamination rate of the folding type of non‐smart phones may have been underestimated, as their keypads could not contact agar plates because they would not opened flatly (we touched the exterior surface of the folding type phones, which did not harbor the keypad, to the agar plate). However, given that folding phones are usually stored in their folded position, bacteria on the outside of the phones are likely more relevant than those within keypads insofar as transmission is concerned.
In summary, our data showed that over one‐fourth of the mobile phones examined in this study were found to harbor potentially pathogenic micro‐organisms. In particular, smart phones of healthcare workers were more frequently contaminated with potentially pathogenic bacteria than were non‐smart phones even after adjusting for the phone size. Preventive measures to minimize the possibility of bacterial transmission via cell phones should be devised.
Disclosure
This study was funded by grant 04‐2011‐1020 from the Seoul National University College of Medicine Research Fund (Seoul, South Korea). The sponsor of the study had no role in the tudy design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. The authors declare that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.
- , , , et al. Evidence‐based policy? The use of mobile phones in hospital. J Public Health (Oxf). 2006;28:299–303.
- , , , , . Is your phone bugged? The incidence of bacteria known to cause nosocomial infection on healthcare workers' mobile phones. J Hosp Infect. 2006;62:123–125.
- , , , , . Bacterial contamination of mobile communication devices in the operative environment. J Hosp Infect. 2007;66:397–398.
- , , , . Review of mobile communication devices as potential reservoirs of nosocomial pathogens. J Hosp Infect. 2009;71:295–300.
- , , . Use of SMS text messaging to improve outpatient attendance. Med J Aust. 2005;183:366–368.
- , , , et al. The use of text messaging to improve attendance in primary care: a randomized controlled trial. Fam Pract. 2006;23:699–705.
- , , , . Mobile phone text messaging in the management of diabetes. J Telemed Telecare. 2004;10:282–285.
- , , , , . Mobile phone text messaging can help young people manage asthma. BMJ. 2002;325:600.
- , , , et al. Use of cellular telephones and transmission of pathogens by medical staff in New York and Israel. Infect Control Hosp Epidemiol. 2007;28:500–503.
- Feature phone. Phone Scoop Web site. Available at: http://www.phonescoop.com/glossary/term.php?gid=310. Accessed June 22, 2011.
- , , . Comparison of two possible routes of pathogen contamination of spinach leaves in a hydroponic cultivation system. J Food Prot 2011;74:1536–1542.
- , , , et al. Use of mobile phones by medical staff at Queen Elizabeth Hospital, Barbados: evidence for both benefit and harm. J Hosp Infect. 2008;70:160–165.
- , , , . Pathogenic bacteria on personal pagers. Am J Infect Control. 2000;28:387–388.
- , , , , , . Bacterial contamination of health care workers' pagers and the efficacy of various disinfecting agents. Pediatr Infect Dis J. 2006;25: 1074–1075.
- , , . Preventing transmission of multidrug‐resistant bacteria in health care settings: a tale of 2 guidelines. Clin Infect Dis. 2006;42:828–835.
- . Environmental contamination makes an important contribution to hospital infection. J Hosp Infect. 2007;65(suppl 2):50–54.
- , , , . Widespread environmental contamination associated with patients with diarrhea and methicillin‐resistant Staphylococcus aureus colonization of the gastrointestinal tract. Infect Control Hosp Epidemiol. 2007;28:1142–1147.
- , , , , . Computer keyboards and faucet handles as reservoirs of nosocomial pathogens in the intensive care unit. Am J Infect Control. 2000;28:465–471.
- , , , , , . Routine disinfection of patients' environmental surfaces. Myth or reality? J Hosp Infect. 1999;42:113–117.
- , , , et al. Evidence‐based policy? The use of mobile phones in hospital. J Public Health (Oxf). 2006;28:299–303.
- , , , , . Is your phone bugged? The incidence of bacteria known to cause nosocomial infection on healthcare workers' mobile phones. J Hosp Infect. 2006;62:123–125.
- , , , , . Bacterial contamination of mobile communication devices in the operative environment. J Hosp Infect. 2007;66:397–398.
- , , , . Review of mobile communication devices as potential reservoirs of nosocomial pathogens. J Hosp Infect. 2009;71:295–300.
- , , . Use of SMS text messaging to improve outpatient attendance. Med J Aust. 2005;183:366–368.
- , , , et al. The use of text messaging to improve attendance in primary care: a randomized controlled trial. Fam Pract. 2006;23:699–705.
- , , , . Mobile phone text messaging in the management of diabetes. J Telemed Telecare. 2004;10:282–285.
- , , , , . Mobile phone text messaging can help young people manage asthma. BMJ. 2002;325:600.
- , , , et al. Use of cellular telephones and transmission of pathogens by medical staff in New York and Israel. Infect Control Hosp Epidemiol. 2007;28:500–503.
- Feature phone. Phone Scoop Web site. Available at: http://www.phonescoop.com/glossary/term.php?gid=310. Accessed June 22, 2011.
- , , . Comparison of two possible routes of pathogen contamination of spinach leaves in a hydroponic cultivation system. J Food Prot 2011;74:1536–1542.
- , , , et al. Use of mobile phones by medical staff at Queen Elizabeth Hospital, Barbados: evidence for both benefit and harm. J Hosp Infect. 2008;70:160–165.
- , , , . Pathogenic bacteria on personal pagers. Am J Infect Control. 2000;28:387–388.
- , , , , , . Bacterial contamination of health care workers' pagers and the efficacy of various disinfecting agents. Pediatr Infect Dis J. 2006;25: 1074–1075.
- , , . Preventing transmission of multidrug‐resistant bacteria in health care settings: a tale of 2 guidelines. Clin Infect Dis. 2006;42:828–835.
- . Environmental contamination makes an important contribution to hospital infection. J Hosp Infect. 2007;65(suppl 2):50–54.
- , , , . Widespread environmental contamination associated with patients with diarrhea and methicillin‐resistant Staphylococcus aureus colonization of the gastrointestinal tract. Infect Control Hosp Epidemiol. 2007;28:1142–1147.
- , , , , . Computer keyboards and faucet handles as reservoirs of nosocomial pathogens in the intensive care unit. Am J Infect Control. 2000;28:465–471.
- , , , , , . Routine disinfection of patients' environmental surfaces. Myth or reality? J Hosp Infect. 1999;42:113–117.