Christine Kilgore

WASHINGTON – Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety–and this time an Institute of Medicine committee has been forewarned that specific “workable” solutions are needed.

The schedules in teaching hospitals “belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?” Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

“If we don't give members of Congress some workable solutions, they'll come up with their own,” she told members of the IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules.

The committee, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of resident works hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read EKGs after long shifts.

Since then–and especially within the past several years–various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

And in a randomized controlled trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working an “intervention” schedule of a 16-hour maximum. Both studies were led by researchers at Harvard University.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's “common duty hour standards” call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions. Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more than every third night, averaged over a 4-week period, the standards say.

The American Council on Graduate Medical Education says it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%. Others argue, however, that enforcement is inadequate and that an independent body is needed to ensure compliance with the rules. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

“I'm a resident who said one thing on a survey and did another thing in real life,” Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. “I'd have a 30-hour shift, work at least 34 hours, and report 16.”

Part of the problem is that residents' workloads tend to remain the same even when shifts are shortened. Surveys of faculty and program directors taken by the American College of Physicians indicate that, even under the current rules, there is often less time for both formal and informal education, less time for ambulatory training, less time at the bedside, and a loss of continuity in care.

“Changing duty hours means changing everything,” from work flow and coverage strategies to transfer-of-care techniques and the “very fundamentals of how patients are treated” and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to take action.

Changes made at Dr. Fried's hospital mean that a patient may now be admitted by one team of residents, treated by another, and discharged by yet another. “And it's up to educators to help residents integrate these experiences,” he said. “I [still] don't know whether I can.”

In Europe, the IOM committee was reminded, physicians and other health care workers are prohibited from working more than 13 hours straight or more than 48–56 hours per week. And for decades, physicians in New Zealand have worked with 16-hour shift limits and 72-hour weekly limits.

Different methods of graduate medical education financing and other health system differences make comparisons difficult, however. Here in the United States, Dr. Fried said, “with duty hour restrictions coming at the same time as patient volumes have increased, as acuity (of illness) in teaching hospitals has increased, and even as our treatments have become higher-stakes treatments, we have the perfect storm.”

WASHINGTON – Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety–and this time an Institute of Medicine committee has been forewarned that specific “workable” solutions are needed.

The schedules in teaching hospitals “belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?” Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

“If we don't give members of Congress some workable solutions, they'll come up with their own,” she told members of the IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules.

The committee, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of resident works hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read EKGs after long shifts.

Since then–and especially within the past several years–various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

And in a randomized controlled trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working an “intervention” schedule of a 16-hour maximum. Both studies were led by researchers at Harvard University.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's “common duty hour standards” call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions. Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more than every third night, averaged over a 4-week period, the standards say.

The American Council on Graduate Medical Education says it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%. Others argue, however, that enforcement is inadequate and that an independent body is needed to ensure compliance with the rules. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

“I'm a resident who said one thing on a survey and did another thing in real life,” Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. “I'd have a 30-hour shift, work at least 34 hours, and report 16.”

Part of the problem is that residents' workloads tend to remain the same even when shifts are shortened. Surveys of faculty and program directors taken by the American College of Physicians indicate that, even under the current rules, there is often less time for both formal and informal education, less time for ambulatory training, less time at the bedside, and a loss of continuity in care.

“Changing duty hours means changing everything,” from work flow and coverage strategies to transfer-of-care techniques and the “very fundamentals of how patients are treated” and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to take action.

Changes made at Dr. Fried's hospital mean that a patient may now be admitted by one team of residents, treated by another, and discharged by yet another. “And it's up to educators to help residents integrate these experiences,” he said. “I [still] don't know whether I can.”

In Europe, the IOM committee was reminded, physicians and other health care workers are prohibited from working more than 13 hours straight or more than 48–56 hours per week. And for decades, physicians in New Zealand have worked with 16-hour shift limits and 72-hour weekly limits.

Different methods of graduate medical education financing and other health system differences make comparisons difficult, however. Here in the United States, Dr. Fried said, “with duty hour restrictions coming at the same time as patient volumes have increased, as acuity (of illness) in teaching hospitals has increased, and even as our treatments have become higher-stakes treatments, we have the perfect storm.”

WASHINGTON – Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety–and this time an Institute of Medicine committee has been forewarned that specific “workable” solutions are needed.

The schedules in teaching hospitals “belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?” Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

“If we don't give members of Congress some workable solutions, they'll come up with their own,” she told members of the IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules.

The committee, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of resident works hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read EKGs after long shifts.

Since then–and especially within the past several years–various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

And in a randomized controlled trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working an “intervention” schedule of a 16-hour maximum. Both studies were led by researchers at Harvard University.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's “common duty hour standards” call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions. Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more than every third night, averaged over a 4-week period, the standards say.

The American Council on Graduate Medical Education says it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%. Others argue, however, that enforcement is inadequate and that an independent body is needed to ensure compliance with the rules. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

“I'm a resident who said one thing on a survey and did another thing in real life,” Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. “I'd have a 30-hour shift, work at least 34 hours, and report 16.”

Part of the problem is that residents' workloads tend to remain the same even when shifts are shortened. Surveys of faculty and program directors taken by the American College of Physicians indicate that, even under the current rules, there is often less time for both formal and informal education, less time for ambulatory training, less time at the bedside, and a loss of continuity in care.

“Changing duty hours means changing everything,” from work flow and coverage strategies to transfer-of-care techniques and the “very fundamentals of how patients are treated” and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to take action.

Changes made at Dr. Fried's hospital mean that a patient may now be admitted by one team of residents, treated by another, and discharged by yet another. “And it's up to educators to help residents integrate these experiences,” he said. “I [still] don't know whether I can.”

In Europe, the IOM committee was reminded, physicians and other health care workers are prohibited from working more than 13 hours straight or more than 48–56 hours per week. And for decades, physicians in New Zealand have worked with 16-hour shift limits and 72-hour weekly limits.

Different methods of graduate medical education financing and other health system differences make comparisons difficult, however. Here in the United States, Dr. Fried said, “with duty hour restrictions coming at the same time as patient volumes have increased, as acuity (of illness) in teaching hospitals has increased, and even as our treatments have become higher-stakes treatments, we have the perfect storm.”

WASHINGTON — Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety—and this time an Institute of Medicine committee has been forewarned that specific “workable” solutions are needed.

The schedules in teaching hospitals “belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?” Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

“If we don't give members of Congress some workable solutions, they'll come up with their own,” she told members of the IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules.

The committee, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of resident works hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read EKGs after long shifts.

Since then—and especially within the past several years—various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

In a randomized trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working an “intervention” schedule of a 16-hour maximum. Both studies were led by researchers at Harvard University.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's “common duty hour standards” call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions.

Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more than every third night, averaged over a 4-week period, the standards say.

The American Council on Graduate Medical Education says it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%.

Others argue that enforcement is inadequate and that an independent body is needed to ensure compliance. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

“I'm a resident who said one thing on a survey and did another thing in real life,” Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. “I'd have a 30-hour shift, work at least 34 hours, and report 16.”

Residents' workloads tend to remain the same even when shifts are shortened. Surveys of faculty and program directors taken by the American College of Physicians indicate that, even under the current rules, there is often less time for both formal and informal education.

“Changing duty hours means changing everything,” from work flow and coverage strategies to transfer-of-care techniques and the “very fundamentals of how patients are treated” and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to take action.

Changes made at Dr. Fried's hospital mean that a patient may be admitted by one team of residents, treated by another, and discharged by yet another. “It's up to educators to help residents integrate these experiences,” he said. “I don't know whether I can.”

WASHINGTON — Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety—and this time an Institute of Medicine committee has been forewarned that specific “workable” solutions are needed.

The schedules in teaching hospitals “belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?” Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

“If we don't give members of Congress some workable solutions, they'll come up with their own,” she told members of the IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules.

The committee, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of resident works hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read EKGs after long shifts.

Since then—and especially within the past several years—various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

In a randomized trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working an “intervention” schedule of a 16-hour maximum. Both studies were led by researchers at Harvard University.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's “common duty hour standards” call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions.

Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more than every third night, averaged over a 4-week period, the standards say.

The American Council on Graduate Medical Education says it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%.

Others argue that enforcement is inadequate and that an independent body is needed to ensure compliance. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

“I'm a resident who said one thing on a survey and did another thing in real life,” Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. “I'd have a 30-hour shift, work at least 34 hours, and report 16.”

Residents' workloads tend to remain the same even when shifts are shortened. Surveys of faculty and program directors taken by the American College of Physicians indicate that, even under the current rules, there is often less time for both formal and informal education.

“Changing duty hours means changing everything,” from work flow and coverage strategies to transfer-of-care techniques and the “very fundamentals of how patients are treated” and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to take action.

Changes made at Dr. Fried's hospital mean that a patient may be admitted by one team of residents, treated by another, and discharged by yet another. “It's up to educators to help residents integrate these experiences,” he said. “I don't know whether I can.”

WASHINGTON — Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety—and this time an Institute of Medicine committee has been forewarned that specific “workable” solutions are needed.

The schedules in teaching hospitals “belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?” Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

“If we don't give members of Congress some workable solutions, they'll come up with their own,” she told members of the IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules.

The committee, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of resident works hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read EKGs after long shifts.

Since then—and especially within the past several years—various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

In a randomized trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working an “intervention” schedule of a 16-hour maximum. Both studies were led by researchers at Harvard University.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's “common duty hour standards” call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions.

Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more than every third night, averaged over a 4-week period, the standards say.

The American Council on Graduate Medical Education says it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%.

Others argue that enforcement is inadequate and that an independent body is needed to ensure compliance. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

“I'm a resident who said one thing on a survey and did another thing in real life,” Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. “I'd have a 30-hour shift, work at least 34 hours, and report 16.”

Residents' workloads tend to remain the same even when shifts are shortened. Surveys of faculty and program directors taken by the American College of Physicians indicate that, even under the current rules, there is often less time for both formal and informal education.

“Changing duty hours means changing everything,” from work flow and coverage strategies to transfer-of-care techniques and the “very fundamentals of how patients are treated” and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to take action.

Changes made at Dr. Fried's hospital mean that a patient may be admitted by one team of residents, treated by another, and discharged by yet another. “It's up to educators to help residents integrate these experiences,” he said. “I don't know whether I can.”

WASHINGTON — Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety—and this time an Institute of Medicine committee has been forewarned that specific "workable" solutions are needed.

The schedules in teaching hospitals "belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?" Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

"If we don't give the members of Congress some workable solutions, they will come up with their own," she told members of the IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules.

The committee, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of resident work hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read EKGs after long shifts.

Since then—and especially within the past several years—various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

And in a randomized controlled trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working an "intervention" schedule of a 16-hour maximum. Both studies were led by researchers at Harvard University.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's "common duty hour standards" call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions.

Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more than every third night, averaged over a 4-week period, the standards say.

The American Council on Graduate Medical Education says that it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%.

Others argue, however, that enforcement is inadequate and that an independent body is needed to ensure compliance with the rules. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

"I'm a resident who said one thing on a survey and did another thing in real life," Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. "I'd have a 30-hour shift, work at least 34 hours, and report 16."

Part of the problem is that residents' workloads tend to remain the same even when shifts are shortened. Surveys of faculty and program directors taken by the American College of Physicians indicate that, even under the current rules, there is often less time for both formal and informal education, less time for ambulatory training, less time at the bedside, and a loss of continuity in care.

"Changing duty hours means changing everything," from work flow and coverage strategies to transfer-of-care techniques and the "very fundamentals of how patients are treated" and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to act.

Changes made at Dr. Fried's hospital mean that a patient may now be admitted by one team of residents, treated by another, and discharged by yet another. "And it's up to educators to help residents integrate these experiences," he said. "I [still] don't know whether I can."

In Europe, the IOM committee was reminded, physicians and other health care workers are prohibited from working more than 13 hours straight or more than 48–56 hours per week. And for decades, physicians in New Zealand have worked with 16-hour shift limits and 72-hour weekly limits.

Different methods of graduate medical education financing and other health system differences make comparisons difficult, however. Here in the United States, Dr. Fried said, "with duty hour restrictions coming at the same time as patient volumes have increased, as acuity (of illness) in teaching hospitals has increased, and even as our treatments have become higher-stakes treatments, we have the perfect storm."

WASHINGTON — Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety—and this time an Institute of Medicine committee has been forewarned that specific "workable" solutions are needed.

The schedules in teaching hospitals "belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?" Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

"If we don't give the members of Congress some workable solutions, they will come up with their own," she told members of the IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules.

The committee, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of resident work hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read EKGs after long shifts.

Since then—and especially within the past several years—various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

And in a randomized controlled trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working an "intervention" schedule of a 16-hour maximum. Both studies were led by researchers at Harvard University.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's "common duty hour standards" call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions.

Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more than every third night, averaged over a 4-week period, the standards say.

The American Council on Graduate Medical Education says that it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%.

Others argue, however, that enforcement is inadequate and that an independent body is needed to ensure compliance with the rules. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

"I'm a resident who said one thing on a survey and did another thing in real life," Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. "I'd have a 30-hour shift, work at least 34 hours, and report 16."

Part of the problem is that residents' workloads tend to remain the same even when shifts are shortened. Surveys of faculty and program directors taken by the American College of Physicians indicate that, even under the current rules, there is often less time for both formal and informal education, less time for ambulatory training, less time at the bedside, and a loss of continuity in care.

"Changing duty hours means changing everything," from work flow and coverage strategies to transfer-of-care techniques and the "very fundamentals of how patients are treated" and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to act.

Changes made at Dr. Fried's hospital mean that a patient may now be admitted by one team of residents, treated by another, and discharged by yet another. "And it's up to educators to help residents integrate these experiences," he said. "I [still] don't know whether I can."

In Europe, the IOM committee was reminded, physicians and other health care workers are prohibited from working more than 13 hours straight or more than 48–56 hours per week. And for decades, physicians in New Zealand have worked with 16-hour shift limits and 72-hour weekly limits.

Different methods of graduate medical education financing and other health system differences make comparisons difficult, however. Here in the United States, Dr. Fried said, "with duty hour restrictions coming at the same time as patient volumes have increased, as acuity (of illness) in teaching hospitals has increased, and even as our treatments have become higher-stakes treatments, we have the perfect storm."

WASHINGTON — Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety—and this time an Institute of Medicine committee has been forewarned that specific "workable" solutions are needed.

The schedules in teaching hospitals "belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?" Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

"If we don't give the members of Congress some workable solutions, they will come up with their own," she told members of the IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules.

The committee, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of resident work hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read EKGs after long shifts.

Since then—and especially within the past several years—various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

And in a randomized controlled trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working an "intervention" schedule of a 16-hour maximum. Both studies were led by researchers at Harvard University.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's "common duty hour standards" call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions.

Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more than every third night, averaged over a 4-week period, the standards say.

The American Council on Graduate Medical Education says that it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%.

Others argue, however, that enforcement is inadequate and that an independent body is needed to ensure compliance with the rules. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

"I'm a resident who said one thing on a survey and did another thing in real life," Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. "I'd have a 30-hour shift, work at least 34 hours, and report 16."

Part of the problem is that residents' workloads tend to remain the same even when shifts are shortened. Surveys of faculty and program directors taken by the American College of Physicians indicate that, even under the current rules, there is often less time for both formal and informal education, less time for ambulatory training, less time at the bedside, and a loss of continuity in care.

"Changing duty hours means changing everything," from work flow and coverage strategies to transfer-of-care techniques and the "very fundamentals of how patients are treated" and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to act.

Changes made at Dr. Fried's hospital mean that a patient may now be admitted by one team of residents, treated by another, and discharged by yet another. "And it's up to educators to help residents integrate these experiences," he said. "I [still] don't know whether I can."

In Europe, the IOM committee was reminded, physicians and other health care workers are prohibited from working more than 13 hours straight or more than 48–56 hours per week. And for decades, physicians in New Zealand have worked with 16-hour shift limits and 72-hour weekly limits.

Different methods of graduate medical education financing and other health system differences make comparisons difficult, however. Here in the United States, Dr. Fried said, "with duty hour restrictions coming at the same time as patient volumes have increased, as acuity (of illness) in teaching hospitals has increased, and even as our treatments have become higher-stakes treatments, we have the perfect storm."

The multibillion dollar wound-care industry has brought a myriad of new support surface options as well as dressings and wound treatments, but nothing works like a "back-to-basics" approach, experts say.

Has optimal practice changed in any significant way since the Agency for Health Care Policy and Research (AHCPR) guidelines for pressure ulcer prevention and treatment came out in 1992 and 1994, asked Rita A. Franz, Ph.D. "I don't think so."

Experts are excited by the potential of ultrasound technology that is being pilot tested in nursing homes for early detection of pressure ulcers.

But at this point, most of the advancements made since the early ′90s have been "advancements in the absence of science," or the absence of scientific evidence for efficacy, said Dr. Franz, Kelting dean and professor in the University of Iowa's College of Nursing in Iowa City

Data suggest, for instance, that patients likely to develop a pressure ulcer should be treated with a pressure-reducing surface or device. A 2004 Cochrane review, in fact, showed that compared with standard hospital mattresses, a variety of devices can lower the incidence of pressure ulcers by about 60%—but experts have been largely unsuccessful in comparing support surfaces based on meaningful functional characteristics, leaving no one device or type of device scientifically superior.

The science of pressure ulcers—etiology, causes, and classification—is still evolving, as is the science of quality measurement. But, despite the change and uncertainties, the vigilance with which nursing homes are attempting to bring the "basics" more consistently and successfully into everyday practice is increasing, and providers are beginning to see results of their efforts.

Certified nursing assistants (CNAs) check patients at Virtua Health and Rehabilitation Centers every day, looking for changes in the skin and reporting such changes immediately to nurses. Nurses also perform head-to-toe skin checks weekly on each patient. In addition, every resident who leaves for a diagnostic test, appointment, or family visit for at least 2 hours receives a full skin check upon returning to a nursing home unit.

Pressure reduction is also thorough: In addition to mattress replacements and overlays for at-risk residents, all residents who cannot reposition themselves have their calves and heels floated on pillows at night, for example. All wheelchairs and geriatric chairs have cushions.

Bed-bound residents are turned every 2 hours, and residents in wheelchairs and geriatric chairs are repositioned every hour. Moisture barriers are used routinely for incontinent patients.

The 2-hour turning/repositioning schedule that is commonly accepted as a standard goal was never subjected to a randomized trial, Dr. Franz notes, but evolved from the results of an observational study done years ago in London on the relationship between amounts of spontaneous nighttime movement and pressure ulcer incidence.

Even without evidence of a casual relationship between good nutrition and pressure ulcer prevention—and with disappointing results of nutritional intervention trials—it still seems only logical to promote good nutrition "on the front lines."

Dr. Jeffrey M. Levine of the Cabrini Wound Healing Center and St. Vincent's Medical Center in New York, encourages physicians to "relearn" the art of wound care that physicians used to study and practice. "Unfortunately, wound care has fallen by the wayside for contemporary doctors." He said he hopes to see new standards and techniques both for pressure relief and for the early detection and assessment of skin breakdown that can lead to the development of advanced stages of pressure ulcers.

With Medicare's upcoming reimbursement changes for hospital-acquired pressure ulcers, hospitals will turn to nursing homes for advice as they revamp their skin assessment programs and educate physicians, he said.

"Acute care has a lot to learn from the long-term care environment," he said. "The long-term care community has been far advanced in their skin care" and advanced in the application of basic processes. The back-to-basics approach that Dr. Levine teaches extends well beyond prevention and into management. "We need to evaluate the wound, keep it clean and moist, remove debris, feed the patient, and treat infections," he said.

The multibillion dollar wound-care industry has brought a myriad of new support surface options as well as dressings and wound treatments, but nothing works like a "back-to-basics" approach, experts say.

Has optimal practice changed in any significant way since the Agency for Health Care Policy and Research (AHCPR) guidelines for pressure ulcer prevention and treatment came out in 1992 and 1994, asked Rita A. Franz, Ph.D. "I don't think so."

Experts are excited by the potential of ultrasound technology that is being pilot tested in nursing homes for early detection of pressure ulcers.

But at this point, most of the advancements made since the early ′90s have been "advancements in the absence of science," or the absence of scientific evidence for efficacy, said Dr. Franz, Kelting dean and professor in the University of Iowa's College of Nursing in Iowa City

Data suggest, for instance, that patients likely to develop a pressure ulcer should be treated with a pressure-reducing surface or device. A 2004 Cochrane review, in fact, showed that compared with standard hospital mattresses, a variety of devices can lower the incidence of pressure ulcers by about 60%—but experts have been largely unsuccessful in comparing support surfaces based on meaningful functional characteristics, leaving no one device or type of device scientifically superior.

The science of pressure ulcers—etiology, causes, and classification—is still evolving, as is the science of quality measurement. But, despite the change and uncertainties, the vigilance with which nursing homes are attempting to bring the "basics" more consistently and successfully into everyday practice is increasing, and providers are beginning to see results of their efforts.

Certified nursing assistants (CNAs) check patients at Virtua Health and Rehabilitation Centers every day, looking for changes in the skin and reporting such changes immediately to nurses. Nurses also perform head-to-toe skin checks weekly on each patient. In addition, every resident who leaves for a diagnostic test, appointment, or family visit for at least 2 hours receives a full skin check upon returning to a nursing home unit.

Pressure reduction is also thorough: In addition to mattress replacements and overlays for at-risk residents, all residents who cannot reposition themselves have their calves and heels floated on pillows at night, for example. All wheelchairs and geriatric chairs have cushions.

Bed-bound residents are turned every 2 hours, and residents in wheelchairs and geriatric chairs are repositioned every hour. Moisture barriers are used routinely for incontinent patients.

The 2-hour turning/repositioning schedule that is commonly accepted as a standard goal was never subjected to a randomized trial, Dr. Franz notes, but evolved from the results of an observational study done years ago in London on the relationship between amounts of spontaneous nighttime movement and pressure ulcer incidence.

Even without evidence of a casual relationship between good nutrition and pressure ulcer prevention—and with disappointing results of nutritional intervention trials—it still seems only logical to promote good nutrition "on the front lines."

Dr. Jeffrey M. Levine of the Cabrini Wound Healing Center and St. Vincent's Medical Center in New York, encourages physicians to "relearn" the art of wound care that physicians used to study and practice. "Unfortunately, wound care has fallen by the wayside for contemporary doctors." He said he hopes to see new standards and techniques both for pressure relief and for the early detection and assessment of skin breakdown that can lead to the development of advanced stages of pressure ulcers.

With Medicare's upcoming reimbursement changes for hospital-acquired pressure ulcers, hospitals will turn to nursing homes for advice as they revamp their skin assessment programs and educate physicians, he said.

"Acute care has a lot to learn from the long-term care environment," he said. "The long-term care community has been far advanced in their skin care" and advanced in the application of basic processes. The back-to-basics approach that Dr. Levine teaches extends well beyond prevention and into management. "We need to evaluate the wound, keep it clean and moist, remove debris, feed the patient, and treat infections," he said.

The multibillion dollar wound-care industry has brought a myriad of new support surface options as well as dressings and wound treatments, but nothing works like a "back-to-basics" approach, experts say.

Has optimal practice changed in any significant way since the Agency for Health Care Policy and Research (AHCPR) guidelines for pressure ulcer prevention and treatment came out in 1992 and 1994, asked Rita A. Franz, Ph.D. "I don't think so."

Experts are excited by the potential of ultrasound technology that is being pilot tested in nursing homes for early detection of pressure ulcers.

But at this point, most of the advancements made since the early ′90s have been "advancements in the absence of science," or the absence of scientific evidence for efficacy, said Dr. Franz, Kelting dean and professor in the University of Iowa's College of Nursing in Iowa City

Data suggest, for instance, that patients likely to develop a pressure ulcer should be treated with a pressure-reducing surface or device. A 2004 Cochrane review, in fact, showed that compared with standard hospital mattresses, a variety of devices can lower the incidence of pressure ulcers by about 60%—but experts have been largely unsuccessful in comparing support surfaces based on meaningful functional characteristics, leaving no one device or type of device scientifically superior.

The science of pressure ulcers—etiology, causes, and classification—is still evolving, as is the science of quality measurement. But, despite the change and uncertainties, the vigilance with which nursing homes are attempting to bring the "basics" more consistently and successfully into everyday practice is increasing, and providers are beginning to see results of their efforts.

Certified nursing assistants (CNAs) check patients at Virtua Health and Rehabilitation Centers every day, looking for changes in the skin and reporting such changes immediately to nurses. Nurses also perform head-to-toe skin checks weekly on each patient. In addition, every resident who leaves for a diagnostic test, appointment, or family visit for at least 2 hours receives a full skin check upon returning to a nursing home unit.

Pressure reduction is also thorough: In addition to mattress replacements and overlays for at-risk residents, all residents who cannot reposition themselves have their calves and heels floated on pillows at night, for example. All wheelchairs and geriatric chairs have cushions.

Bed-bound residents are turned every 2 hours, and residents in wheelchairs and geriatric chairs are repositioned every hour. Moisture barriers are used routinely for incontinent patients.

The 2-hour turning/repositioning schedule that is commonly accepted as a standard goal was never subjected to a randomized trial, Dr. Franz notes, but evolved from the results of an observational study done years ago in London on the relationship between amounts of spontaneous nighttime movement and pressure ulcer incidence.

Even without evidence of a casual relationship between good nutrition and pressure ulcer prevention—and with disappointing results of nutritional intervention trials—it still seems only logical to promote good nutrition "on the front lines."

Dr. Jeffrey M. Levine of the Cabrini Wound Healing Center and St. Vincent's Medical Center in New York, encourages physicians to "relearn" the art of wound care that physicians used to study and practice. "Unfortunately, wound care has fallen by the wayside for contemporary doctors." He said he hopes to see new standards and techniques both for pressure relief and for the early detection and assessment of skin breakdown that can lead to the development of advanced stages of pressure ulcers.

With Medicare's upcoming reimbursement changes for hospital-acquired pressure ulcers, hospitals will turn to nursing homes for advice as they revamp their skin assessment programs and educate physicians, he said.

"Acute care has a lot to learn from the long-term care environment," he said. "The long-term care community has been far advanced in their skin care" and advanced in the application of basic processes. The back-to-basics approach that Dr. Levine teaches extends well beyond prevention and into management. "We need to evaluate the wound, keep it clean and moist, remove debris, feed the patient, and treat infections," he said.

WASHINGTON — Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety—and this time an Institute of Medicine committee has been forewarned that specific “workable” solutions are needed.

The schedules in teaching hospitals “belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?” Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

The IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of residents' work hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read ECGs after long shifts.

Since then—and especially within the past several years—various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

And in a randomized controlled trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working a 16-hour maximum. Both studies were led by researchers at Harvard University, Boston.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's “common duty hour standards” call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions.

Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more often than every third night, averaged over a 4-week period, the standards say.

The council said it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%.

Others argue, however, that enforcement is inadequate and that an independent body is needed to ensure compliance with the rules. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

“I'm a resident who said one thing on a survey and did another thing in real life,” Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. “I'd have a 30-hour shift, work at least 34 hours, and report 16.”

Part of the problem is that residents' workloads tend to remain the same even when shifts are shortened.

“Changing duty hours means changing everything,” from work flow and coverage strategies to transfer-of-care techniques and the “very fundamentals of how patients are treated” and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to take action.

Changes made at Dr. Fried's hospital mean that a patient may now be admitted by one team of residents, treated by another, and discharged by yet another. “And it's up to educators to help residents integrate these experiences,” he said. “I [still] don't know whether I can.”

In Europe, the IOM committee was reminded, physicians and other health care workers are prohibited from working more than 13 hours straight or more than 48–56 hours per week.

Different methods of graduate medical education financing and other health system differences make comparisons difficult, however. Here in the United States, Dr. Fried said, “with duty hour restrictions coming at the same time as patient volumes have increased, as acuity (of illness) in teaching hospitals has increased, and even as our treatments have become higher-stakes treatments, we have the perfect storm.”

WASHINGTON — Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety—and this time an Institute of Medicine committee has been forewarned that specific “workable” solutions are needed.

The schedules in teaching hospitals “belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?” Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

The IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of residents' work hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read ECGs after long shifts.

Since then—and especially within the past several years—various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

And in a randomized controlled trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working a 16-hour maximum. Both studies were led by researchers at Harvard University, Boston.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's “common duty hour standards” call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions.

Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more often than every third night, averaged over a 4-week period, the standards say.

The council said it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%.

Others argue, however, that enforcement is inadequate and that an independent body is needed to ensure compliance with the rules. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

“I'm a resident who said one thing on a survey and did another thing in real life,” Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. “I'd have a 30-hour shift, work at least 34 hours, and report 16.”

Part of the problem is that residents' workloads tend to remain the same even when shifts are shortened.

“Changing duty hours means changing everything,” from work flow and coverage strategies to transfer-of-care techniques and the “very fundamentals of how patients are treated” and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to take action.

Changes made at Dr. Fried's hospital mean that a patient may now be admitted by one team of residents, treated by another, and discharged by yet another. “And it's up to educators to help residents integrate these experiences,” he said. “I [still] don't know whether I can.”

In Europe, the IOM committee was reminded, physicians and other health care workers are prohibited from working more than 13 hours straight or more than 48–56 hours per week.

Different methods of graduate medical education financing and other health system differences make comparisons difficult, however. Here in the United States, Dr. Fried said, “with duty hour restrictions coming at the same time as patient volumes have increased, as acuity (of illness) in teaching hospitals has increased, and even as our treatments have become higher-stakes treatments, we have the perfect storm.”

WASHINGTON — Five years after the establishment of across-specialty rules to limit resident work hours, the issue of trainee schedules in teaching hospitals is again under the microscope as a continuing threat to patient safety—and this time an Institute of Medicine committee has been forewarned that specific “workable” solutions are needed.

The schedules in teaching hospitals “belie virtually all the tenets of providing good health care. How can we profess to provide the best possible quality of care when we know we have staff members who are operating at levels of sleep deprivation so severe that they are similar to someone driving under the influence of alcohol?” Dr. Carolyn Clancy, director of the federal Agency for Health Care Research and Quality, asked at a meeting sponsored by the Institute of Medicine.

The IOM's Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules, which held the first of four workshops in December, was formed at the request of Rep. John D. Dingell (D-Mich.) and colleagues on the House Committee on Energy and Commerce as part of an investigation into preventable medical errors. The IOM will publish a report including strategies and actions for implementing safe work schedules in February 2009.

The issue of residents' work hours received relatively little attention in the IOM's landmark 1999 report on medical errors, experts said at the workshop, despite several decades of research on the effects of sleep deprivation on human performance and research more specifically showing an impaired ability of interns to read ECGs after long shifts.

Since then—and especially within the past several years—various studies have demonstrated the effects of sleep deprivation in medical residents and have shown that reductions in work hours can reduce errors, physicians told the committee.

A prospective, national survey of more than 2,700 interns, for instance, showed that residents were seven times more likely to report a harmful fatigue-related error when they worked five or more 24-hour shifts in a month than when they worked no 24-hour shifts. They were four times more likely to report a fatal error.

And in a randomized controlled trial, residents had twice as many EEG-documented attention failures at night when working the traditional schedule of 24- to 30-hour shifts than when working a 16-hour maximum. Both studies were led by researchers at Harvard University, Boston.

Dr. Christopher P. Landrigan, who directs the Sleep and Patient Safety Program at Brigham and Women's Hospital, Boston, said the Harvard research has also shown that residents working 24- to 30-hour shifts make five times as many serious diagnostic errors as do those scheduled to work 16 hours or less. They're also twice as likely to crash their cars, and they suffer 61% more needlestick injuries, he told the IOM committee.

Limits instituted by the American Council on Graduate Medical Education in 2003 mark shifts of 24–30 hours as acceptable. The council's “common duty hour standards” call for a 24-hour limit on continuous duty, with an additional 6 hours allowed for continuity and the transfer of care, as well as an 80-hour weekly limit averaged over 4 weeks. Programs can request an increase of up to 8 hours a week and can apply for further exemptions.

Residents must also have a minimum rest period of 10 hours between duty periods, 1 in 7 days free from patient care responsibilities, and in-house call no more often than every third night, averaged over a 4-week period, the standards say.

The council said it has issued citations to individual programs for duty hour violations and has done resident surveys that demonstrate a compliance rate of 94%.

Others argue, however, that enforcement is inadequate and that an independent body is needed to ensure compliance with the rules. Culture and tradition are so entrenched, they say, that too little has changed and that residents routinely underreport hours for fear of retaliation.

“I'm a resident who said one thing on a survey and did another thing in real life,” Dr. Sunny Ramchandani, past chair of the AMA Residents and Fellows Section, told the IOM committee. “I'd have a 30-hour shift, work at least 34 hours, and report 16.”

Part of the problem is that residents' workloads tend to remain the same even when shifts are shortened.

“Changing duty hours means changing everything,” from work flow and coverage strategies to transfer-of-care techniques and the “very fundamentals of how patients are treated” and what residents are responsible for, said Dr. Ethan Fried, director of graduate medical education at St. Luke's-Roosevelt Hospital Center in New York.

Hospitals in New York state have been dealing with work hour limits and supervision requirements since 1988, several years after the death of Libby Zion in a teaching hospital spurred the state to take action.

Changes made at Dr. Fried's hospital mean that a patient may now be admitted by one team of residents, treated by another, and discharged by yet another. “And it's up to educators to help residents integrate these experiences,” he said. “I [still] don't know whether I can.”

In Europe, the IOM committee was reminded, physicians and other health care workers are prohibited from working more than 13 hours straight or more than 48–56 hours per week.

Different methods of graduate medical education financing and other health system differences make comparisons difficult, however. Here in the United States, Dr. Fried said, “with duty hour restrictions coming at the same time as patient volumes have increased, as acuity (of illness) in teaching hospitals has increased, and even as our treatments have become higher-stakes treatments, we have the perfect storm.”

BETHESDA, MD. – Recurrent abdominal pain appears to be part of a larger syndrome of somatization and anxiety, Lynette Dufton reported at a meeting sponsored by the National Institutes of Health Pain Consortium.

Physiologic factors may contribute to pain episodes in children with recurrent abdominal pain, “but I think anxiety is a key part of this,” said Ms. Dufton of Vanderbilt University in Nashville, Tenn.

“Providers should assess comorbid psychological symptoms in these children, and maybe refer them for [therapies such as] cognitive-behavioral therapy,” she said in an interview at her poster presentation on the study.

Using various parent and child reports of somatization and anxiety, different measures of stress reactivity, and the “cold pressor” test of pain tolerance and sensitivity, Ms. Dufton compared 21 children with recurrent abdominal pain (9 boys) with 21 children with a diagnosed anxiety disorder (11 boys) and 21 children who were well (9 boys). The children in each group had a mean age of either 11 or 12 years.

A total of 67% of the children with recurrent abdominal pain–a problem experienced by 8%–25% of school-aged children–met criteria for an anxiety disorder, compared with 100% of the children with anxiety and 6% of the well children.

On parent and self-reports of somatization and anxiety, such as the Child Behavior Checklist for Ages 6–18 (CBCL/6–18) and the Youth Self-Report, children with recurrent abdominal pain rated significantly higher on internalizing symptoms, such as anxiety and somatic complaints, than did well children.

They did not differ from children with anxiety disorders on the CBCL's measures of anxiety, but they did report significantly more somatic complaints, Ms. Dufton said.

Children with recurrent abdominal pain also reported different levels of stress reactivity on various measures from those reported by well children. On one self-reported measure–the “Responses to Stress Questionnaire”–those children exhibited higher levels of stress reactivity than both well and anxious children.

The cold pressor test measures the length of time one can keep one's hand and arm in ice-cold water (pain tolerance) and rates pain at 40 seconds using a visual analog scale (pain sensitivity). Unexpectedly, there were no differences in pain tolerance among the groups of children, Ms. Dufton said.

BETHESDA, MD. – Recurrent abdominal pain appears to be part of a larger syndrome of somatization and anxiety, Lynette Dufton reported at a meeting sponsored by the National Institutes of Health Pain Consortium.

Physiologic factors may contribute to pain episodes in children with recurrent abdominal pain, “but I think anxiety is a key part of this,” said Ms. Dufton of Vanderbilt University in Nashville, Tenn.

“Providers should assess comorbid psychological symptoms in these children, and maybe refer them for [therapies such as] cognitive-behavioral therapy,” she said in an interview at her poster presentation on the study.

Using various parent and child reports of somatization and anxiety, different measures of stress reactivity, and the “cold pressor” test of pain tolerance and sensitivity, Ms. Dufton compared 21 children with recurrent abdominal pain (9 boys) with 21 children with a diagnosed anxiety disorder (11 boys) and 21 children who were well (9 boys). The children in each group had a mean age of either 11 or 12 years.

A total of 67% of the children with recurrent abdominal pain–a problem experienced by 8%–25% of school-aged children–met criteria for an anxiety disorder, compared with 100% of the children with anxiety and 6% of the well children.

On parent and self-reports of somatization and anxiety, such as the Child Behavior Checklist for Ages 6–18 (CBCL/6–18) and the Youth Self-Report, children with recurrent abdominal pain rated significantly higher on internalizing symptoms, such as anxiety and somatic complaints, than did well children.

They did not differ from children with anxiety disorders on the CBCL's measures of anxiety, but they did report significantly more somatic complaints, Ms. Dufton said.

Children with recurrent abdominal pain also reported different levels of stress reactivity on various measures from those reported by well children. On one self-reported measure–the “Responses to Stress Questionnaire”–those children exhibited higher levels of stress reactivity than both well and anxious children.

The cold pressor test measures the length of time one can keep one's hand and arm in ice-cold water (pain tolerance) and rates pain at 40 seconds using a visual analog scale (pain sensitivity). Unexpectedly, there were no differences in pain tolerance among the groups of children, Ms. Dufton said.

BETHESDA, MD. – Recurrent abdominal pain appears to be part of a larger syndrome of somatization and anxiety, Lynette Dufton reported at a meeting sponsored by the National Institutes of Health Pain Consortium.

Physiologic factors may contribute to pain episodes in children with recurrent abdominal pain, “but I think anxiety is a key part of this,” said Ms. Dufton of Vanderbilt University in Nashville, Tenn.

“Providers should assess comorbid psychological symptoms in these children, and maybe refer them for [therapies such as] cognitive-behavioral therapy,” she said in an interview at her poster presentation on the study.

Using various parent and child reports of somatization and anxiety, different measures of stress reactivity, and the “cold pressor” test of pain tolerance and sensitivity, Ms. Dufton compared 21 children with recurrent abdominal pain (9 boys) with 21 children with a diagnosed anxiety disorder (11 boys) and 21 children who were well (9 boys). The children in each group had a mean age of either 11 or 12 years.

A total of 67% of the children with recurrent abdominal pain–a problem experienced by 8%–25% of school-aged children–met criteria for an anxiety disorder, compared with 100% of the children with anxiety and 6% of the well children.

On parent and self-reports of somatization and anxiety, such as the Child Behavior Checklist for Ages 6–18 (CBCL/6–18) and the Youth Self-Report, children with recurrent abdominal pain rated significantly higher on internalizing symptoms, such as anxiety and somatic complaints, than did well children.

They did not differ from children with anxiety disorders on the CBCL's measures of anxiety, but they did report significantly more somatic complaints, Ms. Dufton said.

Children with recurrent abdominal pain also reported different levels of stress reactivity on various measures from those reported by well children. On one self-reported measure–the “Responses to Stress Questionnaire”–those children exhibited higher levels of stress reactivity than both well and anxious children.

The cold pressor test measures the length of time one can keep one's hand and arm in ice-cold water (pain tolerance) and rates pain at 40 seconds using a visual analog scale (pain sensitivity). Unexpectedly, there were no differences in pain tolerance among the groups of children, Ms. Dufton said.

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his coinvestigators wrote (Diabetes Care 2007:30;999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain-signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

He hopes to recruit 180 patients to participate in the investigation and expects it to take at least another year to complete.

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his coinvestigators wrote (Diabetes Care 2007:30;999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain-signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

He hopes to recruit 180 patients to participate in the investigation and expects it to take at least another year to complete.

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his coinvestigators wrote (Diabetes Care 2007:30;999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain-signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

He hopes to recruit 180 patients to participate in the investigation and expects it to take at least another year to complete.

BETHESDA, MD. – A growing body of research suggests that dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) has been “one of the most mysterious of the pain disorders”–one with no known cause, leaving few physicians willing to treat it and many others believing the disorder to be psychosomatic, said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston.

However, “we now understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II … [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as having CRPS-I (defined as having no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (having a known nerve injury). However, “seeing them in the clinic with the same presentation, it doesn't take a great leap of faith to believe these guys [with CRPS-I] have a nerve injury that wasn't discovered,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. These patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Epidemiologic studies show that most patients diagnosed with CRPS are young (an average age of 39) and female (a 4:1 ratio), and that most patients recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

Results of ipsilateral and contralateral control biopsies discount a hypothesized effect of swelling on the number of nerve endings, and the fact that a control group of seven osteoarthritis patients with severe leg pain, edema, and disuse had no loss of nerve endings discounts the hypothesis that pain “burns out” nerve endings, Dr. Oaklander said. The identification of posttraumatic small-fiber loss in patients with CRPS has been validated by several other research groups, she noted.

There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia.

“The problem isn't so much with the nociceptive fibers that are degenerated–it's with their neighbors,” Dr. Oaklander said.

New animal models developed to prove causality, including her own laboratory's mouse model of distal nerve injury, have reproduced the symptoms of CRPS–from allodynia and dysautonomia to bone loss, dystonia, and a regional and mirrorlike spread of symptoms–and have shown that long-lasting pain behaviors usually remit and that the prevalence of allodynia is independent of lesion size.

“We really can't assume that it takes a severe injury to leave someone with chronic pain–in fact, the opposite may be true,” Dr. Oaklander said. “Most of those who have small-fiber damage, however, may be able to regenerate their axons, and those whose axons do not regenerate may have either mild or no degeneration of their vasa nervorum,” she said.

This patient's swollen ankle and shallow ulcers were caused by neurogenic edema, which may be triggered by the loss of small-fiber nerve endings. Courtesy Dr. Anne Louise Oaklander

BETHESDA, MD. – A growing body of research suggests that dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) has been “one of the most mysterious of the pain disorders”–one with no known cause, leaving few physicians willing to treat it and many others believing the disorder to be psychosomatic, said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston.

However, “we now understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II … [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as having CRPS-I (defined as having no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (having a known nerve injury). However, “seeing them in the clinic with the same presentation, it doesn't take a great leap of faith to believe these guys [with CRPS-I] have a nerve injury that wasn't discovered,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. These patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Epidemiologic studies show that most patients diagnosed with CRPS are young (an average age of 39) and female (a 4:1 ratio), and that most patients recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

Results of ipsilateral and contralateral control biopsies discount a hypothesized effect of swelling on the number of nerve endings, and the fact that a control group of seven osteoarthritis patients with severe leg pain, edema, and disuse had no loss of nerve endings discounts the hypothesis that pain “burns out” nerve endings, Dr. Oaklander said. The identification of posttraumatic small-fiber loss in patients with CRPS has been validated by several other research groups, she noted.

There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia.

“The problem isn't so much with the nociceptive fibers that are degenerated–it's with their neighbors,” Dr. Oaklander said.

New animal models developed to prove causality, including her own laboratory's mouse model of distal nerve injury, have reproduced the symptoms of CRPS–from allodynia and dysautonomia to bone loss, dystonia, and a regional and mirrorlike spread of symptoms–and have shown that long-lasting pain behaviors usually remit and that the prevalence of allodynia is independent of lesion size.

“We really can't assume that it takes a severe injury to leave someone with chronic pain–in fact, the opposite may be true,” Dr. Oaklander said. “Most of those who have small-fiber damage, however, may be able to regenerate their axons, and those whose axons do not regenerate may have either mild or no degeneration of their vasa nervorum,” she said.

This patient's swollen ankle and shallow ulcers were caused by neurogenic edema, which may be triggered by the loss of small-fiber nerve endings. Courtesy Dr. Anne Louise Oaklander

BETHESDA, MD. – A growing body of research suggests that dysfunction of the small-fiber axons that mediate pain sensation and autonomic function underlies complex regional pain syndrome, Dr. Anne Louise Oaklander said at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Complex regional pain syndrome (CRPS) has been “one of the most mysterious of the pain disorders”–one with no known cause, leaving few physicians willing to treat it and many others believing the disorder to be psychosomatic, said Dr. Oaklander, a neurologist at Harvard Medical School and director of the nerve injury unit at Massachusetts General Hospital, Boston.

However, “we now understand the disease biology,” she said. “It's time to abandon the dichotomy between CRPS I and CRPS II … [and to] consider changing the name to 'posttraumatic neuralgia.'

“Small-fiber axonopathy is what causes this,” Dr. Oaklander said.

Current diagnostic criteria for CRPS include the occurrence of a noxious event or other cause of immobilization; continuing or disproportionate pain, allodynia, or hyperalgesia; and edema, changes in skin blood flow, or abnormal sweating in the region of pain.

Most patients are classified as having CRPS-I (defined as having no known nerve injury); fewer than 10% receive a diagnosis of CRPS-II (having a known nerve injury). However, “seeing them in the clinic with the same presentation, it doesn't take a great leap of faith to believe these guys [with CRPS-I] have a nerve injury that wasn't discovered,” she said.

CRPS is “what I call a focal 'pain-plus' syndrome. These patients have chronic pain but also vascular dysregulation and sometimes dystonia, contralesional 'mirror' pain … osteopenia, [and focal changes in other innervated tissues],” Dr. Oaklander said. “[The disease] reflects pathological processes, not normal pain mechanisms.”

Epidemiologic studies show that most patients diagnosed with CRPS are young (an average age of 39) and female (a 4:1 ratio), and that most patients recover spontaneously.

Skin biopsies done in Dr. Oaklander's lab of 18 CRPS-I patients show 30% fewer small-fiber nerve endings in painful CRPS-affected areas.

Results of ipsilateral and contralateral control biopsies discount a hypothesized effect of swelling on the number of nerve endings, and the fact that a control group of seven osteoarthritis patients with severe leg pain, edema, and disuse had no loss of nerve endings discounts the hypothesis that pain “burns out” nerve endings, Dr. Oaklander said. The identification of posttraumatic small-fiber loss in patients with CRPS has been validated by several other research groups, she noted.

There is good evidence that trauma disproportionately damages small fibers, probably because they lack protective myelin and saltatory conduction. Pain results when undamaged axons within the same nerve, as well as regenerating axon spouts, malfunction, firing without cause, for instance, triggering neurogenic edema and tissue ischemia.

“The problem isn't so much with the nociceptive fibers that are degenerated–it's with their neighbors,” Dr. Oaklander said.

New animal models developed to prove causality, including her own laboratory's mouse model of distal nerve injury, have reproduced the symptoms of CRPS–from allodynia and dysautonomia to bone loss, dystonia, and a regional and mirrorlike spread of symptoms–and have shown that long-lasting pain behaviors usually remit and that the prevalence of allodynia is independent of lesion size.

“We really can't assume that it takes a severe injury to leave someone with chronic pain–in fact, the opposite may be true,” Dr. Oaklander said. “Most of those who have small-fiber damage, however, may be able to regenerate their axons, and those whose axons do not regenerate may have either mild or no degeneration of their vasa nervorum,” she said.

This patient's swollen ankle and shallow ulcers were caused by neurogenic edema, which may be triggered by the loss of small-fiber nerve endings. Courtesy Dr. Anne Louise Oaklander

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his colleagues wrote (Diabetes Care 2007; 30:999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his colleagues wrote (Diabetes Care 2007; 30:999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

BETHESDA, MD. — Despite little evidence backing their efficacy, complementary and alternative medicine therapies are used regularly by more than 40% of patients with painful diabetic neuropathy, Dr. Martin Stevens said at a meeting sponsored by the National Institute of Health's Pain Consortium.

Well-designed, prospective, randomized trials of complementary and alternative medicine (CAM) therapies have been relatively few and far between. Many of the CAM approaches—which range from α-lipoic acid and benfotiamine to biofield therapies, near-infrared phototherapy, and static- and pulsed-magnetic field therapies—pose “significant challenges” for adequate blinding and determination of a placebo response, said Dr. Stevens, professor of medicine at the University of Birmingham (England).

Overall, the literature shows that about 25% of patients taking CAM therapies for painful diabetic neuropathy report a response, “which is very close to what we'd consider a placebo response,” he said. Yet surveys suggest that only about one-third of patients with painful diabetic neuropathy respond to conventional pharmacologic therapies, such as nonsteroidal drugs, antidepressants, and nonaddicting analgesics, which explains the growing popularity of CAM approaches, Dr. Stevens said.

A recently published study of Reiki, a hands-on therapy based on the theoretical existence of a bioenergy field intrinsic to the human body, suggests how powerful the placebo response and the therapeutic effects of ongoing involvement with a health care provider can be, Dr. Stevens noted.

Just over 200 patients with type 2 diabetes and painful diabetic neuropathy were randomized to receive Reiki, mimic Reiki, or usual care. Patients in the Reiki and mimic-Reiki groups underwent two treatments in the first week, followed by weekly treatments, for a total of 12 weeks. Patients in the usual-care group were assessed at the start and end of the 12-week period, said Dr. Stevens, one of the study investigators.

Global pain scores and walking distance improved from baseline in both the Reiki and mimic-Reiki groups, but not in the usual-care group.

There were no significant differences between the two groups at the final visit, indicating that the reduction in pain is consistent with the notion that “a sustained partnership between the health care provider and the patient can have direct therapeutic benefits,” Dr. Stevens and his colleagues wrote (Diabetes Care 2007; 30:999–1001).

“Seeing the patient on a regular basis clearly does help their perception and their pain … whatever else you chose to do to them,” he said at the NIH meeting.

The etiology of pain complicating diabetes is still poorly understood, he noted. It may result from the dysfunction of pain signaling pathways at multiple levels, such as cutaneous nociceptors, afferent neurons, and the spinal and supraspinal pathways, he said.

A survey of 180 consecutive outpatients with diabetic neuropathy and other peripheral neuropathies found that the most frequently used CAM therapies were megavitamins (35%), magnetics (30%), acupuncture (30%), herbal remedies (22%), and chiropractic manipulation (21%).

Almost 50% had tried more than one form of alternative treatment, and almost half did not consult a physician before starting CAM. Patients with diabetic neuropathy used CAM more frequently than patients with other neuropathies, the survey showed (J. Neurol. Sci. 2004;218:59–66).

Dr. Stevens and other investigators at the University of Birmingham are recruiting patients for a 12-week, randomized, double-blind, controlled study of taurine, a ubiquitous β-amino acid found in high concentrations in the central and peripheral nervous systems. The amino acid—probably one of the better-studied CAM therapies for painful diabetic neuropathy—functions as an antioxidant, calcium modulator, analgesic, and neuromodulator, Dr. Steven said.

BETHESDA, MD. — A small study of hydrotherapy in labor has documented a significant decrease in anxiety, a fall in stress hormones and unexpectedly, a fall in oxytocin levels and a decrease in uterine contraction frequency, Rebecca Benfield, Ph.D., reported at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Dr. Benfield, a certified nurse-midwife, has long seen benefit in bathing during labor: Women enjoy it and feel better as their pain and anxiety are decreased.

She and others have not known, however, exactly what lies behind the maternal response to hydrotherapy—the psychophysiologic mechanisms of action, for instance, and the possible effects on uterine contractility.

The recently completed study was the first, she said, in which plasma stress hormones were measured during immersion. The findings suggest that the therapy warrants attention in a randomized controlled trial and further investigation as an intervention for labor dysfunction, reported Dr. Benfield, associate professor of nursing and clinical assistant professor of obstetrics and gynecology at East Carolina University in Greenville, N.C.

Eleven healthy women in spontaneous active labor (cervical dilatation of 3–6 cm) at term were immersed to the xiphoid in 37° C water for 1 hour.

Blood samples were drawn before immersion and repeated at 15 and 45 minutes of hydrotherapy. Fetal heart rate and uterine contractions were monitored, and visual analog scales for anxiety and pain were administered before each blood draw. No analgesia was administered during the study.

Mean anxiety scores decreased from 51 mm (on a scale of 100 mm) to 33 mm at 15 minutes and 29 mm at 45 minutes. Pain also decreased, with the changes more significant in women with higher baseline pain scores vs. those with lower baseline pain scores, Dr. Benfield and her associates at East Carolina University reported in a poster presentation.

Statistically significant decreases in vasopressin (from a mean of 5.1 pg/mL at baseline to 4 pg/mL at both 15 and 45 minutes), oxytocin (from approximately 193 pg/mL at baseline to 153 pg/mL at 15 minutes and 154 pg/mL at 30 minutes), and cortisol were among the other changes.

Cortisol decreased twice as much after 15 minutes for the high baseline pain group (a mean decrease of 6.2 mcg/dL), compared with the low baseline pain group (a mean decrease of 3.1 mcg/dL).

The level of beta-endorphins increased significantly, but surprisingly, levels of epinephrine and norepinephrine did not change significantly, Dr. Benfield reported.

All women had a positive plasma volume shift (+4.1% at 15 minutes and at 45 minutes) that was positively correlated with contraction duration, while contraction frequency decreased significantly.

Contraction intensity was not measured, she said in an interview, and is therefore “a missing piece” in the understanding of hydrotherapy's effect on labor contractility.

Hydrotherapy “probably, however, will pan out to be a potentially good intervention for women with high levels of pain and those who are having some type of dysfunctional [labor] pattern … because theoretically it should provide better perfusion to the uterus,” Dr. Benfield said.

Thus far, she said, it appears that the “immersion effect—the hydrostatic pressure of the water—is what's driving the physiologic changes,” she said.

The results may also demonstrate two physiologic roles of oxytocin: its traditional role in uterine contractility and a novel role as an antistress hormone, according to Dr. Edward R. Newton, a coinvestigator for the study.

Although the study's sample size is too small to draw any conclusions about labor outcomes, no maternal or neonatal infections were attributed to the bathing, the researchers said.

BETHESDA, MD. — A small study of hydrotherapy in labor has documented a significant decrease in anxiety, a fall in stress hormones and unexpectedly, a fall in oxytocin levels and a decrease in uterine contraction frequency, Rebecca Benfield, Ph.D., reported at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Dr. Benfield, a certified nurse-midwife, has long seen benefit in bathing during labor: Women enjoy it and feel better as their pain and anxiety are decreased.

She and others have not known, however, exactly what lies behind the maternal response to hydrotherapy—the psychophysiologic mechanisms of action, for instance, and the possible effects on uterine contractility.

The recently completed study was the first, she said, in which plasma stress hormones were measured during immersion. The findings suggest that the therapy warrants attention in a randomized controlled trial and further investigation as an intervention for labor dysfunction, reported Dr. Benfield, associate professor of nursing and clinical assistant professor of obstetrics and gynecology at East Carolina University in Greenville, N.C.

Eleven healthy women in spontaneous active labor (cervical dilatation of 3–6 cm) at term were immersed to the xiphoid in 37° C water for 1 hour.

Blood samples were drawn before immersion and repeated at 15 and 45 minutes of hydrotherapy. Fetal heart rate and uterine contractions were monitored, and visual analog scales for anxiety and pain were administered before each blood draw. No analgesia was administered during the study.

Mean anxiety scores decreased from 51 mm (on a scale of 100 mm) to 33 mm at 15 minutes and 29 mm at 45 minutes. Pain also decreased, with the changes more significant in women with higher baseline pain scores vs. those with lower baseline pain scores, Dr. Benfield and her associates at East Carolina University reported in a poster presentation.

Statistically significant decreases in vasopressin (from a mean of 5.1 pg/mL at baseline to 4 pg/mL at both 15 and 45 minutes), oxytocin (from approximately 193 pg/mL at baseline to 153 pg/mL at 15 minutes and 154 pg/mL at 30 minutes), and cortisol were among the other changes.

Cortisol decreased twice as much after 15 minutes for the high baseline pain group (a mean decrease of 6.2 mcg/dL), compared with the low baseline pain group (a mean decrease of 3.1 mcg/dL).

The level of beta-endorphins increased significantly, but surprisingly, levels of epinephrine and norepinephrine did not change significantly, Dr. Benfield reported.

All women had a positive plasma volume shift (+4.1% at 15 minutes and at 45 minutes) that was positively correlated with contraction duration, while contraction frequency decreased significantly.

Contraction intensity was not measured, she said in an interview, and is therefore “a missing piece” in the understanding of hydrotherapy's effect on labor contractility.

Hydrotherapy “probably, however, will pan out to be a potentially good intervention for women with high levels of pain and those who are having some type of dysfunctional [labor] pattern … because theoretically it should provide better perfusion to the uterus,” Dr. Benfield said.

Thus far, she said, it appears that the “immersion effect—the hydrostatic pressure of the water—is what's driving the physiologic changes,” she said.

The results may also demonstrate two physiologic roles of oxytocin: its traditional role in uterine contractility and a novel role as an antistress hormone, according to Dr. Edward R. Newton, a coinvestigator for the study.

Although the study's sample size is too small to draw any conclusions about labor outcomes, no maternal or neonatal infections were attributed to the bathing, the researchers said.

BETHESDA, MD. — A small study of hydrotherapy in labor has documented a significant decrease in anxiety, a fall in stress hormones and unexpectedly, a fall in oxytocin levels and a decrease in uterine contraction frequency, Rebecca Benfield, Ph.D., reported at a meeting sponsored by the National Institutes of Health's Pain Consortium.

Dr. Benfield, a certified nurse-midwife, has long seen benefit in bathing during labor: Women enjoy it and feel better as their pain and anxiety are decreased.

She and others have not known, however, exactly what lies behind the maternal response to hydrotherapy—the psychophysiologic mechanisms of action, for instance, and the possible effects on uterine contractility.

The recently completed study was the first, she said, in which plasma stress hormones were measured during immersion. The findings suggest that the therapy warrants attention in a randomized controlled trial and further investigation as an intervention for labor dysfunction, reported Dr. Benfield, associate professor of nursing and clinical assistant professor of obstetrics and gynecology at East Carolina University in Greenville, N.C.

Eleven healthy women in spontaneous active labor (cervical dilatation of 3–6 cm) at term were immersed to the xiphoid in 37° C water for 1 hour.

Blood samples were drawn before immersion and repeated at 15 and 45 minutes of hydrotherapy. Fetal heart rate and uterine contractions were monitored, and visual analog scales for anxiety and pain were administered before each blood draw. No analgesia was administered during the study.

Mean anxiety scores decreased from 51 mm (on a scale of 100 mm) to 33 mm at 15 minutes and 29 mm at 45 minutes. Pain also decreased, with the changes more significant in women with higher baseline pain scores vs. those with lower baseline pain scores, Dr. Benfield and her associates at East Carolina University reported in a poster presentation.

Statistically significant decreases in vasopressin (from a mean of 5.1 pg/mL at baseline to 4 pg/mL at both 15 and 45 minutes), oxytocin (from approximately 193 pg/mL at baseline to 153 pg/mL at 15 minutes and 154 pg/mL at 30 minutes), and cortisol were among the other changes.

Cortisol decreased twice as much after 15 minutes for the high baseline pain group (a mean decrease of 6.2 mcg/dL), compared with the low baseline pain group (a mean decrease of 3.1 mcg/dL).

The level of beta-endorphins increased significantly, but surprisingly, levels of epinephrine and norepinephrine did not change significantly, Dr. Benfield reported.

All women had a positive plasma volume shift (+4.1% at 15 minutes and at 45 minutes) that was positively correlated with contraction duration, while contraction frequency decreased significantly.

Contraction intensity was not measured, she said in an interview, and is therefore “a missing piece” in the understanding of hydrotherapy's effect on labor contractility.

Hydrotherapy “probably, however, will pan out to be a potentially good intervention for women with high levels of pain and those who are having some type of dysfunctional [labor] pattern … because theoretically it should provide better perfusion to the uterus,” Dr. Benfield said.

Thus far, she said, it appears that the “immersion effect—the hydrostatic pressure of the water—is what's driving the physiologic changes,” she said.

The results may also demonstrate two physiologic roles of oxytocin: its traditional role in uterine contractility and a novel role as an antistress hormone, according to Dr. Edward R. Newton, a coinvestigator for the study.

Although the study's sample size is too small to draw any conclusions about labor outcomes, no maternal or neonatal infections were attributed to the bathing, the researchers said.