啥！住院醫師連續工時 最多32小時

[李誠民]

Residents' Duty Hours — Toward an Empirical Narrative
Lisa Rosenbaum, M.D., and Daniela Lamas, M.D.
N Engl J Med 2012; 367:2044-2049November 22, 2012DOI: 10.1056/NEJMsr1210160

It all began with a tragedy. In March 1984, a fatal error occurred in a U.S. teaching hospital. Eighteen-year-old Libby Zion died because of a lethal drug interaction. The cause was serotonin syndrome — a rather obscure condition in 1984. The residents caring for Zion diagnosed a viral syndrome with “hysterical symptoms.”1 In the intense scrutiny that followed, their misdiagnosis was attributed in part to their exhaustion, since at the time they had been at work for 18 hours straight. But was exhaustion really the cause?
What if the problem stemmed 起源from lack of supervision? What if the intern had not yet learned to distinguish “sick” from “not sick”? On the other hand, what if the young doctor, when prescribing the fateful dose of Demerol (meperidine), had been warned by a computer alert about potential adverse interactions between Zion's inpatient and outpatient medications (which included phenelzine)? Or could Zion's death have been avoided if the intern had had a nap?
Though addressing the many potential sources of error remains relevant to both trainee education and patient safety, the regulatory changes since Zion's death have focused primarily on mitigating resident fatigue. In 1999, New York State implemented rules limiting residents to an 80-hour workweek, and in 2003, the Accreditation Council for Graduate Medical Education (ACGME) adopted a similar national standard2 (see text box Timeline of Changes in Residents' Work Hours. 2-5). Still, public concern about patient safety escalated, leading Congress, in 2007, to commission a report from the Institute of Medicine (IOM) evaluating the effects of duty-hour reform and suggesting future directions. After a year-long review, the IOM recommended that interns' shifts not exceed 16 hours and that residents working up to 30 hours be allotted 分配 指派5 hours for a nap午睡 打盹兒 (see Figure 1Figure 1 Sample Schedule of Surgical Intern on Surgical Oncology Rotation, November 2011. for a sample resident's schedule).
In 2010, after a 16-member ACGME task force reviewed the IOM's recommendations, along with testimony誓詞 證據 from medical organizations, sleep researchers, and patient advocates, the rules were revised (Table 1Table 1 Changes in Accreditation Council for Graduate Medical Education (ACGME) Work-Hour Requirements, and Comparison with Institute of Medicine (IOM) Recommendations.). The most notable change was that interns' shifts were not to exceed 16 hours. “Strategic napping” was strongly suggested, and programs were required to teach residents “alertness management.” These rules were implemented in July 2011, and oversight was intensified.
The controversy surrounding work-hour reform spans decades, but a certain resignation seems to have settled over our profession. Physicians who believe that these rules are destroying our professional ethic are often perceived as curmudgeonly and have thus quieted their objections. Trainees who would prefer fatigue to unfinished patient care must nevertheless comply, or their programs will face steep fines and loss of accreditation. And program directors who aspire to design innovative educational environments must instead direct most of their energy toward the increasing administrative burden these requirements confer.
For us, the debate is irresistible. We are both trainees and third-generation physicians. We love being doctors but enjoy lives outside the hospital. And we've watched these rules transform our educational environments. But having spent the past year as editorial fellows at the Journal, becoming increasingly aware of the gaps between data and practice, we were struck by the disconnect between the duty-hour limits and the evidence base to support them. We therefore seek not to debate whether these rules are right or wrong, but to figure out how their effects can be rigorously assessed.
By interviewing members of the ACGME, patient advocates, program directors, educational experts, and trainees, we were exposed to both sides of the debate. Though we didn't always agree with one another, we emerged with a fundamental shared concern: the uniform implementation of the rules has left the profession without a mechanism for adequate evaluation. Our profession would never accept a new drug or device without clinical trials delineating benefit and risk. Why assume that any less is at stake in implementing a new training system?
As Sanjay Desai, director of the internal medicine residency program at Johns Hopkins, remarked, “Everybody says we're done with duty hours and we can't go back. That's a defeatist attitude. This is the future of American medicine, and the risk is too great. Creating more regulation in the absence of data is not a tenable solution.”
The path of least resistance is simply to accept the rules we've been handed. But to create delivery systems that are ultimately suited to meeting patients' diverse health needs, investigators must be able to study different approaches. Right now, such assessment is impossible. We therefore propose that the ACGME grant training programs a research exemption to permit such investigations.
Current Inflexibility
Seeking to better understand the justification for the uniform implementation of the current system, we visited the ACGME. Though we expected to find the organization bureaucratic官僚, with little insight into how these rules have transformed medical culture, we instead felt sympathetic to the ACGME's dual and often conflicted mission: to accredit and to educate. Given the political mandate to improve patient safety, the threat that legislators will usurp the ACGME's regulatory power looms large. Thus, the organization's need to prove itself an adequate accreditor often trumps the imperative to educate.
The ACGME acknowledges that the need to create a uniform standard has forced the development of rules that cater to the lowest common denominator, rather than allowing each specialty to mold an environment that suits its trainees' learning needs and ambitions. “Standards are standards, and we tried to be flexible,” says Ingrid Philibert, ACGME senior vice president, “but my sense is we've created a rigid monster without flexibility.”
Had researchers established the superiority of this one-size-fits-all model to a more traditional training approach or to approaches meeting each specialty's distinct needs, implementing the system in all programs and specialties would be logical. Given the absence of a mechanism for prospective analysis, however, we must rely on previous research. So do we know enough to accept this system as the model for training future physicians?
The short answer is no. But the longer answer, which has contributed to the long-running controversy, is that there are data to support every opinion.
Key Data
For the public, the most compelling data are those suggesting that practicing medicine while sleep-deprived is akin to working while drunk.6 For instance, a 2004 study comparing reduced work hours with standard schedules showed that interns working longer hours had higher rates of “attentional failures,” as defined by the “intrusion of slow-rolling eye movements” on continuous electrooculographic monitoring while awake.7 Being tired, of course, is something everyone understands, so data on harms wrought by sleep deprivation make sense intuitively. Indeed, a recent study showed that 80% of Americans surveyed would want to see a different doctor if they knew theirs had been working more than 24 consecutive hours.8
But it's one thing to show that people get tired when they don't sleep much; it's another to prove that fatigue impairs judgment in a way that results in patient harm. Christopher Landrigan, of Harvard Medical School, a leading investigator behind work-hour reform, has devoted his academic life to studying this link. Motivated by his own memory of an ICU call night when he slept through an urgent page regarding a decompensating patient, Landrigan led the only randomized trial to date on work-hour reform — a single-center study of medical interns in an intensive care setting. Interns were randomly assigned to a standard every-third-night schedule, a schedule in which 30-hour shifts alternated with 10-hour shifts, or an intervention schedule limiting interns to a maximum of 16 consecutive hours of work. The interns whose work hours did not exceed 16 did make fewer “serious medical errors,” but there were no differences among groups in total rates of adverse events.9
Kevin Volpp, of the University of Pennsylvania, and his colleagues published tandem studies in 2007, based on Medicare and Veterans Affairs claims data. They too found that, overall, duty-hour limitations have not reduced medical errors. Recognizing ubiquitous quality-improvement efforts as potential confounders, the investigators used a difference-in-differences approach to compare rates of change in medical error among teaching and nonteaching hospitals.10 Despite this adjustment, Volpp acknowledges the limitations of observational data. He notes that “a number of factors make it difficult to discern cause and effect” because the reform itself may induce behavioral responses that have offsetting positive or negative effects. For example, “any patient admitted to the hospital might have 20 to 25 people taking care of them. Who is assigned responsibility of care? It gets very complicated.”
Given the complexity of a systemwide intervention such as work-hour reform, this type of attribution bias is not unique to observational data. Indeed, after the publication of Landrigan's randomized trial, three residents from the intervention group wrote a letter questioning the study's conclusions.11 They wrote: “Worried residents and attending physicians, aware that the interns on the intervention schedule were poorly informed, took a more active role in patient care, making the majority of decisions and more closely supervising the interns' actions. This hypervigilance may have strongly biased the study toward a positive result.” Physicians who, in recent years, have increasingly assumed the work once performed by interns know that such concerns regarding this potential study bias are not unfounded.
An Ostensibly Flexible System
Nevertheless, the only way to move beyond our observations and mitigate biases such as heightened oversight would be to conduct more and larger randomized trials, with data collected over a longer period of time. Instead, the results of Landrigan's trial are now seen as a major justification for further work-hour restrictions, and no subsequent randomized trials have been undertaken to study this issue. Why is that?
The reasons are many, but the most salient factor is the lack of flexibility to allow such trials to be conducted. Robust analysis depends on the existence of adequate controls so that different approaches to residents' shift lengths and total work hours can be compared over time.
Ostensibly, the ACGME recognized this need for ongoing analysis. Indeed, the wording of the current regulations suggests that such flexibility is possible, but this option has proved to be an empty promise. The 2011 restrictions state that programs may apply for exemptions for “experimentation and innovation” and note that “requests for . . . projects that may deviate from the institutional, common, and/or specialty-specific program requirements must be approved in advance by the Review Committee.”
But no program has been approved for such an exemption for duty hours, Philibert says. She notes that although one request for exemption was received, from a group of program directors in internal medicine, the ACGME “had to turn it down” because of a prior decision that it wouldn't grant any duty-hour exemptions for 2 years under the “innovation rule.”
The program directors had proposed the exemption after the approval of the 2010 duty-hour limits but before implementation. The exemption would have allowed them to delay uniform implementation of the new standard for 1 to 2 years while they conducted a comparative assessment of the 2003 and 2010 standards, focused on the length of intern shifts, with patient safety as the prespecified principal outcome measure.
In December 2010, Thomas Nasca, the ACGME's chief executive officer, responded to this request in a letter to one of the program directors. After mentioning the 2000 comments received during the regulations' vetting period and the fact that various advocacy groups had petitioned the Occupational Safety and Health Administration (OSHA) to limit all residents to 16-hour shifts, he wrote: “Although I realize that there is interest in pursuing an experiment to compare 16 hours to 28 and 30 hours, given the current sociopolitical milieu, including the interest in having OSHA assume ownership and oversight of compliance of duty hours, I do not believe that the ACGME Board would be inclined to consider a proposal to waive the new requirement for 16 hours.”
Philibert told us that the phased implementation of the Next Accreditation System, scheduled for July 2013, will be accompanied by a revised policy-and-procedure manual that may offer high-performing programs some added flexibility to innovate. Though this manual is still under review, our understanding is that it will not permit innovation in the realm of duty-hour limits, which remains a core requirement. Nevertheless, Philibert emphasizes that the ACGME carefully balances “the desire and need for flexibility for programs and residents” against demands for “rigorous” management of duty-hour limits voiced by parties purporting to speak for the public. She adds, “Both [sides] have legitimate, strong arguments.”
A Proposal
Though the ACGME must be accountable to both the public and the profession, the public's voice has often been louder than ours. When a patient dies after a medical error, the emotional salience of the event often trumps the imperative to accurately discern cause and effect, leaving us more receptive to anecdote than hard data. Cases such as Libby Zion's have captivated the public's imagination. As Susan Day, cochair of the ACGME task force, notes, “Increasingly, the public feels that it has a right to understand, and in a way direct, how people are trained as physicians.”
Undoubtedly, both proponents and opponents of work-hour reform believe they are doing the right thing for our system. But without a robust evidence base, it is too easy to justify our intuitive beliefs by relying on fragmentary data. Though we can't change human nature, we can conduct investigations that allow a more evidence-based narrative to emerge.
To inform this understanding, the ACGME must grant programs a research exemption. A research consortium could then be created to pool data on a prespecified set of outcomes, fostering both small-scale innovation and an understanding of more widespread trends. Research efforts should consider not only the effects of hours worked, but also the relative importance of such factors as supervision, the structure of clinical teams, handoffs, simulator-based learning, and the amount of direct patient care. As noted by John Ioannidis of Stanford University School of Medicine, such a consortium would enable several randomized trials to occur simultaneously while ultimately informing a prospective meta-analysis.
Both short-term and long-term outcomes should be considered. For instance, when assessing work hours, do we look at safety within the confines of a 16-hour shift, or can we examine the effects of a bad handoff 6 months after the fact? Equally critical, how do we understand what will happen 5 years down the road, when today's trainee is suddenly facing 100-hour workweeks because that's what it takes to get the work done?
Given the complexity of the underlying questions and the diversity of outcomes to be assessed, the ACGME should take the lead in ensuring that such research is encouraged and rewarded. By spearheading this investigative undertaking, the organization would be given an opportunity to truly fulfill its dual roles as accreditor and educator.
Finally, convincing the ACGME to permit research exemptions is partly predicated on convincing the public that a more sophisticated understanding of medical education requires formal research. In a recent editorial describing the need for rigorous research on resident education and work-hour reform, Volpp and Vineet Arora acknowledged methodologic challenges but noted that an important hurdle will be making such investigations a national research priority.12 In our political system, trainee education, which is not disease-specific, lacks a powerful lobby. The ACGME alone cannot change public sentiment. As a profession, we must not only develop methods for evaluating our educational systems, but also convince the public that informing this understanding is critical to their health.
Future Directions
As invested as the public may be in enhancing hospital safety, patients are also increasingly disenchanted with their relationships with their physicians. Creating safe hospitals, training competent physicians, and preserving the sanctity of the physician–patient relationship need not be mutually exclusive goals, but it is naive to assume that rules in pursuit of one aim don't also affect the other aims.
We believe we must question the assumptions that have polarized the profession and left us with a system we cannot evaluate. Each assumption — that sleep deprivation makes for bad doctors, that ours will become a generation of shift workers, that one standard of training suits all trainees — is distinct in substance. But they all similarly lack substantiation. To continue implementing changes without rigorous data is simply not safe.
The current chapter of the work-hour story need not be the last. But to best serve the public and the profession, the next chapter should begin with data.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Source Information
From the Philadelphia VA Medical Center and the Robert Wood Johnson Foundation Clinical Scholars Program, University of Pennsylvania, Philadelphia (L.R.); and the Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Boston (D.L.).
p.s.:1. Occupational Safety and Health Administration (OSHA) ,美國主管工時與勞動條件的OSHA2當初做住院醫師工時(duty hours)都閃避不訂規定,而推給ACGME自訂,憑甚麼我國勞委會有能力?
2.要等到2014年,美國IOM才在有結論(?)出來,
3.勞委會好好比照勞工(多麼不幸!--醫師)保障該有的勞動條件,首先要承認住院醫師(包過實習醫師),的過勞死--職業傷害..............

[李誠民]

Residents' Duty Hours — Toward an Empirical Narrative
Lisa Rosenbaum, M.D., and Daniela Lamas, M.D.
N Engl J Med 2012; 367:2044-2049November 22, 2012DOI: 10.1056/NEJMsr1210160

It all began with a tragedy. In March 1984, a fatal error occurred in a U.S. teaching hospital. Eighteen-year-old Libby Zion died because of a lethal drug interaction. The cause was serotonin syndrome — a rather obscure condition in 1984. The residents caring for Zion diagnosed a viral syndrome with “hysterical symptoms.”1 In the intense scrutiny that followed, their misdiagnosis was attributed in part to their exhaustion, since at the time they had been at work for 18 hours straight. But was exhaustion really the cause?
What if the problem stemmed 起源from lack of supervision? What if the intern had not yet learned to distinguish “sick” from “not sick”? On the other hand, what if the young doctor, when prescribing the fateful dose of Demerol (meperidine), had been warned by a computer alert about potential adverse interactions between Zion's inpatient and outpatient medications (which included phenelzine)? Or could Zion's death have been avoided if the intern had had a nap?
Though addressing the many potential sources of error remains relevant to both trainee education and patient safety, the regulatory changes since Zion's death have focused primarily on mitigating resident fatigue. In 1999, New York State implemented rules limiting residents to an 80-hour workweek, and in 2003, the Accreditation Council for Graduate Medical Education (ACGME) adopted a similar national standard2 (see text box Timeline of Changes in Residents' Work Hours. 2-5). Still, public concern about patient safety escalated, leading Congress, in 2007, to commission a report from the Institute of Medicine (IOM) evaluating the effects of duty-hour reform and suggesting future directions. After a year-long review, the IOM recommended that interns' shifts not exceed 16 hours and that residents working up to 30 hours be allotted 分配 指派5 hours for a nap午睡 打盹兒 (see Figure 1Figure 1 Sample Schedule of Surgical Intern on Surgical Oncology Rotation, November 2011. for a sample resident's schedule).
In 2010, after a 16-member ACGME task force reviewed the IOM's recommendations, along with testimony誓詞 證據 from medical organizations, sleep researchers, and patient advocates, the rules were revised (Table 1Table 1 Changes in Accreditation Council for Graduate Medical Education (ACGME) Work-Hour Requirements, and Comparison with Institute of Medicine (IOM) Recommendations.). The most notable change was that interns' shifts were not to exceed 16 hours. “Strategic napping” was strongly suggested, and programs were required to teach residents “alertness management.” These rules were implemented in July 2011, and oversight was intensified.
The controversy surrounding work-hour reform spans decades, but a certain resignation seems to have settled over our profession. Physicians who believe that these rules are destroying our professional ethic are often perceived as curmudgeonly and have thus quieted their objections. Trainees who would prefer fatigue to unfinished patient care must nevertheless comply, or their programs will face steep fines and loss of accreditation. And program directors who aspire to design innovative educational environments must instead direct most of their energy toward the increasing administrative burden these requirements confer.
For us, the debate is irresistible. We are both trainees and third-generation physicians. We love being doctors but enjoy lives outside the hospital. And we've watched these rules transform our educational environments. But having spent the past year as editorial fellows at the Journal, becoming increasingly aware of the gaps between data and practice, we were struck by the disconnect between the duty-hour limits and the evidence base to support them. We therefore seek not to debate whether these rules are right or wrong, but to figure out how their effects can be rigorously assessed.
By interviewing members of the ACGME, patient advocates, program directors, educational experts, and trainees, we were exposed to both sides of the debate. Though we didn't always agree with one another, we emerged with a fundamental shared concern: the uniform implementation of the rules has left the profession without a mechanism for adequate evaluation. Our profession would never accept a new drug or device without clinical trials delineating benefit and risk. Why assume that any less is at stake in implementing a new training system?
As Sanjay Desai, director of the internal medicine residency program at Johns Hopkins, remarked, “Everybody says we're done with duty hours and we can't go back. That's a defeatist attitude. This is the future of American medicine, and the risk is too great. Creating more regulation in the absence of data is not a tenable solution.”
The path of least resistance is simply to accept the rules we've been handed. But to create delivery systems that are ultimately suited to meeting patients' diverse health needs, investigators must be able to study different approaches. Right now, such assessment is impossible. We therefore propose that the ACGME grant training programs a research exemption to permit such investigations.
Current Inflexibility
Seeking to better understand the justification for the uniform implementation of the current system, we visited the ACGME. Though we expected to find the organization bureaucratic官僚, with little insight into how these rules have transformed medical culture, we instead felt sympathetic to the ACGME's dual and often conflicted mission: to accredit and to educate. Given the political mandate to improve patient safety, the threat that legislators will usurp the ACGME's regulatory power looms large. Thus, the organization's need to prove itself an adequate accreditor often trumps the imperative to educate.
The ACGME acknowledges that the need to create a uniform standard has forced the development of rules that cater to the lowest common denominator, rather than allowing each specialty to mold an environment that suits its trainees' learning needs and ambitions. “Standards are standards, and we tried to be flexible,” says Ingrid Philibert, ACGME senior vice president, “but my sense is we've created a rigid monster without flexibility.”
Had researchers established the superiority of this one-size-fits-all model to a more traditional training approach or to approaches meeting each specialty's distinct needs, implementing the system in all programs and specialties would be logical. Given the absence of a mechanism for prospective analysis, however, we must rely on previous research. So do we know enough to accept this system as the model for training future physicians?
The short answer is no. But the longer answer, which has contributed to the long-running controversy, is that there are data to support every opinion.
Key Data
For the public, the most compelling data are those suggesting that practicing medicine while sleep-deprived is akin to working while drunk.6 For instance, a 2004 study comparing reduced work hours with standard schedules showed that interns working longer hours had higher rates of “attentional failures,” as defined by the “intrusion of slow-rolling eye movements” on continuous electrooculographic monitoring while awake.7 Being tired, of course, is something everyone understands, so data on harms wrought by sleep deprivation make sense intuitively. Indeed, a recent study showed that 80% of Americans surveyed would want to see a different doctor if they knew theirs had been working more than 24 consecutive hours.8
But it's one thing to show that people get tired when they don't sleep much; it's another to prove that fatigue impairs judgment in a way that results in patient harm. Christopher Landrigan, of Harvard Medical School, a leading investigator behind work-hour reform, has devoted his academic life to studying this link. Motivated by his own memory of an ICU call night when he slept through an urgent page regarding a decompensating patient, Landrigan led the only randomized trial to date on work-hour reform — a single-center study of medical interns in an intensive care setting. Interns were randomly assigned to a standard every-third-night schedule, a schedule in which 30-hour shifts alternated with 10-hour shifts, or an intervention schedule limiting interns to a maximum of 16 consecutive hours of work. The interns whose work hours did not exceed 16 did make fewer “serious medical errors,” but there were no differences among groups in total rates of adverse events.9
Kevin Volpp, of the University of Pennsylvania, and his colleagues published tandem studies in 2007, based on Medicare and Veterans Affairs claims data. They too found that, overall, duty-hour limitations have not reduced medical errors. Recognizing ubiquitous quality-improvement efforts as potential confounders, the investigators used a difference-in-differences approach to compare rates of change in medical error among teaching and nonteaching hospitals.10 Despite this adjustment, Volpp acknowledges the limitations of observational data. He notes that “a number of factors make it difficult to discern cause and effect” because the reform itself may induce behavioral responses that have offsetting positive or negative effects. For example, “any patient admitted to the hospital might have 20 to 25 people taking care of them. Who is assigned responsibility of care? It gets very complicated.”
Given the complexity of a systemwide intervention such as work-hour reform, this type of attribution bias is not unique to observational data. Indeed, after the publication of Landrigan's randomized trial, three residents from the intervention group wrote a letter questioning the study's conclusions.11 They wrote: “Worried residents and attending physicians, aware that the interns on the intervention schedule were poorly informed, took a more active role in patient care, making the majority of decisions and more closely supervising the interns' actions. This hypervigilance may have strongly biased the study toward a positive result.” Physicians who, in recent years, have increasingly assumed the work once performed by interns know that such concerns regarding this potential study bias are not unfounded.
An Ostensibly Flexible System
Nevertheless, the only way to move beyond our observations and mitigate biases such as heightened oversight would be to conduct more and larger randomized trials, with data collected over a longer period of time. Instead, the results of Landrigan's trial are now seen as a major justification for further work-hour restrictions, and no subsequent randomized trials have been undertaken to study this issue. Why is that?
The reasons are many, but the most salient factor is the lack of flexibility to allow such trials to be conducted. Robust analysis depends on the existence of adequate controls so that different approaches to residents' shift lengths and total work hours can be compared over time.
Ostensibly, the ACGME recognized this need for ongoing analysis. Indeed, the wording of the current regulations suggests that such flexibility is possible, but this option has proved to be an empty promise. The 2011 restrictions state that programs may apply for exemptions for “experimentation and innovation” and note that “requests for . . . projects that may deviate from the institutional, common, and/or specialty-specific program requirements must be approved in advance by the Review Committee.”
But no program has been approved for such an exemption for duty hours, Philibert says. She notes that although one request for exemption was received, from a group of program directors in internal medicine, the ACGME “had to turn it down” because of a prior decision that it wouldn't grant any duty-hour exemptions for 2 years under the “innovation rule.”
The program directors had proposed the exemption after the approval of the 2010 duty-hour limits but before implementation. The exemption would have allowed them to delay uniform implementation of the new standard for 1 to 2 years while they conducted a comparative assessment of the 2003 and 2010 standards, focused on the length of intern shifts, with patient safety as the prespecified principal outcome measure.
In December 2010, Thomas Nasca, the ACGME's chief executive officer, responded to this request in a letter to one of the program directors. After mentioning the 2000 comments received during the regulations' vetting period and the fact that various advocacy groups had petitioned the Occupational Safety and Health Administration (OSHA) to limit all residents to 16-hour shifts, he wrote: “Although I realize that there is interest in pursuing an experiment to compare 16 hours to 28 and 30 hours, given the current sociopolitical milieu, including the interest in having OSHA assume ownership and oversight of compliance of duty hours, I do not believe that the ACGME Board would be inclined to consider a proposal to waive the new requirement for 16 hours.”
Philibert told us that the phased implementation of the Next Accreditation System, scheduled for July 2013, will be accompanied by a revised policy-and-procedure manual that may offer high-performing programs some added flexibility to innovate. Though this manual is still under review, our understanding is that it will not permit innovation in the realm of duty-hour limits, which remains a core requirement. Nevertheless, Philibert emphasizes that the ACGME carefully balances “the desire and need for flexibility for programs and residents” against demands for “rigorous” management of duty-hour limits voiced by parties purporting to speak for the public. She adds, “Both [sides] have legitimate, strong arguments.”
A Proposal
Though the ACGME must be accountable to both the public and the profession, the public's voice has often been louder than ours. When a patient dies after a medical error, the emotional salience of the event often trumps the imperative to accurately discern cause and effect, leaving us more receptive to anecdote than hard data. Cases such as Libby Zion's have captivated the public's imagination. As Susan Day, cochair of the ACGME task force, notes, “Increasingly, the public feels that it has a right to understand, and in a way direct, how people are trained as physicians.”
Undoubtedly, both proponents and opponents of work-hour reform believe they are doing the right thing for our system. But without a robust evidence base, it is too easy to justify our intuitive beliefs by relying on fragmentary data. Though we can't change human nature, we can conduct investigations that allow a more evidence-based narrative to emerge.
To inform this understanding, the ACGME must grant programs a research exemption. A research consortium could then be created to pool data on a prespecified set of outcomes, fostering both small-scale innovation and an understanding of more widespread trends. Research efforts should consider not only the effects of hours worked, but also the relative importance of such factors as supervision, the structure of clinical teams, handoffs, simulator-based learning, and the amount of direct patient care. As noted by John Ioannidis of Stanford University School of Medicine, such a consortium would enable several randomized trials to occur simultaneously while ultimately informing a prospective meta-analysis.
Both short-term and long-term outcomes should be considered. For instance, when assessing work hours, do we look at safety within the confines of a 16-hour shift, or can we examine the effects of a bad handoff 6 months after the fact? Equally critical, how do we understand what will happen 5 years down the road, when today's trainee is suddenly facing 100-hour workweeks because that's what it takes to get the work done?
Given the complexity of the underlying questions and the diversity of outcomes to be assessed, the ACGME should take the lead in ensuring that such research is encouraged and rewarded. By spearheading this investigative undertaking, the organization would be given an opportunity to truly fulfill its dual roles as accreditor and educator.
Finally, convincing the ACGME to permit research exemptions is partly predicated on convincing the public that a more sophisticated understanding of medical education requires formal research. In a recent editorial describing the need for rigorous research on resident education and work-hour reform, Volpp and Vineet Arora acknowledged methodologic challenges but noted that an important hurdle will be making such investigations a national research priority.12 In our political system, trainee education, which is not disease-specific, lacks a powerful lobby. The ACGME alone cannot change public sentiment. As a profession, we must not only develop methods for evaluating our educational systems, but also convince the public that informing this understanding is critical to their health.
Future Directions
As invested as the public may be in enhancing hospital safety, patients are also increasingly disenchanted with their relationships with their physicians. Creating safe hospitals, training competent physicians, and preserving the sanctity of the physician–patient relationship need not be mutually exclusive goals, but it is naive to assume that rules in pursuit of one aim don't also affect the other aims.
We believe we must question the assumptions that have polarized the profession and left us with a system we cannot evaluate. Each assumption — that sleep deprivation makes for bad doctors, that ours will become a generation of shift workers, that one standard of training suits all trainees — is distinct in substance. But they all similarly lack substantiation. To continue implementing changes without rigorous data is simply not safe.
The current chapter of the work-hour story need not be the last. But to best serve the public and the profession, the next chapter should begin with data.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Source Information
From the Philadelphia VA Medical Center and the Robert Wood Johnson Foundation Clinical Scholars Program, University of Pennsylvania, Philadelphia (L.R.); and the Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Boston (D.L.).
p.s.:1. Occupational Safety and Health Administration (OSHA) ,美國主管工時與勞動條件的OSHA2當初做住院醫師工時(duty hours)都閃避不訂規定,而推給ACGME自訂,憑甚麼我國勞委會有能力?
2.要等到2014年,美國IOM才在有結論(?)出來,
3.勞委會好好比照勞工(多麼不幸!--醫師)保障該有的勞動條件,首先要承認住院醫師(包過實習醫師),的過勞死--職業傷害..............

[李誠民]

醫師如果是聘雇關係,勞保費繳納是照實申報,退休卻有天花板限定(43,900?),合理嗎?!台灣政府搶錢,已經是習慣了,還要大喊公平正義?!,不發聲不代表同意,您跟搶匪如何對話?!

[luck]

所以當台灣「看不見的手一直試著殺死五大科醫師」的時候
(過勞、低薪、高額賠償、大量的訟訴、無形的壓力…)
就只有走山可以救台灣啦
魯冰花革命!!! 柔性罷工中……

哈哈哈---真愛說笑---你們這些醫師沒x--魯冰花革命!!! 柔性罷工中---真是笑死當官的與資本家了,呵呵呵-----

[李誠民]

去年底,英國有醫師全國大罷工(因為英國經濟衰退,每年醫療經費以每年減少10%--給NHS分配,長達十年以上,以致NHS要求政府,調派軍中急診專業醫師,補充許多醫院的急診人力空虛,....英國是社會主義的公醫制度,所以有許多怪現象在近十年層出不窮,台灣健保制度有差嗎?政府還是視而不見,空口喊口號,欺騙人民--騙選票而以,;再前一年,荷蘭也有醫師全國大罷工---社會主義社會醫療健康照護體系,台灣倒底是走美國資本主義的自由經濟市場醫療照護體系(私人保險)還是英國 歐洲的社會主義(--稅收),......
台灣只是宣稱台灣健保的普遍性,卻不顧財政來源,壓榨醫護等專業人士的勞力,可能嗎?!只圖利財團法人醫院與公家醫學中心(台大 榮總...),所以台灣成為希臘第二也不遠了?!公保 軍保 教保(不包括私校)與勞保明顯不同,這不是社會動盪的潛在危機嗎?.....
台灣健保費不是最實際的健保稅?!勞保費不是勞保稅嗎?!

[李誠民]

台灣實習醫師不一定有勞保,因為是學生身分,雇用醫院可以不 幫他加保?!
我曾參加民進黨不分區前立委--黃淑英女士公聽會--"住院醫師過勞死...", 當場我問大學生打工--7-11,都需要加保勞保,否則犯法!!!,實習醫師卻因是學生只有學保(保障有多少?聽說學保增加了?! 有實質保障嗎?!),甚麼茉莉花革命?!只是被工勞盟利用的一群可憐人!!!!.......

[Boogy]

請政府官員們, 衛生署, 健保局, 勞委會,
的各位同仁,

示範一下: 連續工作32小時
給大夥 瞧瞧

沒有本事的話 ,
己所不欲 ; 勿施於人..

[yes]

立這種法只會製造更多問題, 在台灣, 所有的問題到最後還是只能靠自己

[cefotaxime]

回想以前住院醫師的值班日子，值班後隔天常常恍惚，原來那就是《酒醉》，
那幾年，原來我是酒醉在CPR的。
那幾年，原來我都是下班酒醉騎摩托車回宿舍。

[ndmcofbr2]

沒有勞基法的保護....我們是被予取予求的一群
如果勞基法也放寬所有勞工可以連續工作32小時
大貨車駕駛連續駕車32小時
知名電子工廠都可以連續工作32小時
還有許許多多公司都可以連續工作
最樂的應該是背後的老闆吧....

[gucci37]

要有配套措施：連續工時超過24小時後，

如有醫療事故，一律由醫院老板和立法的政府賠。

[李誠民]

如有醫療事故，一律由醫院老板和立法的政府賠。有理!!!(?)
否則住院醫師被壓榨--過勞死!實習醫師是學生,保不保勞保是要看醫院(Provider)得臉色決定(真可笑!!!)勞工被踐踏(不如軍 公 教)也是應該的,台灣政府(不論藍 綠或統獨)都是盜匪行為 公 教)也是應該的,有基本人權嗎?!
只是法西斯獨裁政體而以!!!

[hjh]

奇怪
台灣為什麼很喜歡先定一些漏洞百出的規則
然後之後再來修
然後又要修不修的讓各團體在那邊角力來角力去
就像公投法、健保法、醫療法......一大堆法都有問題待修啦
與其訂出白痴規則 不如不要訂了 等真的弄好了再頒布實施啊

本案依然是
沒罰責
假政績

[李誠民]

Service: An Essential Component of Graduate Medical Education
Jennifer C. Kesselheim, M.D., M.Ed., and Christine K. Cassel, M.D., M.A.C.P.
N Engl J Med 2013; 368:500-501February 7, 2013DOI: 10.1056/NEJMp1214850
住院醫師(&/orIIntern)到底是訓練(Training)&/or服務(Survice)?!,請看下列文章::

Medicine is a service profession, and commitment to service is a hallmark of humanistic人性的 人文主義 physicians. Despite the importance of service, there are few widely disseminated definitions of it. One comes from the Arnold P. Gold Foundation, an organization whose programs on humanism in medicine have been integrated into 93% of U.S. medical schools; the Gold Foundation defines service as “the sharing of one's talent天才 天資, time, and resources with those in need; giving beyond what is required.”1 Though fundamental to physicians' professional role, service is being harmfully undermined within the medical profession and within graduate medical education (GME) in particular.
Service and education have been set in conflict ever since the original GME infrastructure emerged in the early 20th century. Whereas medical students pay tuition教學 學費 for their education, residents continue to learn while becoming an invaluable part of an institution's workforce. Residents are trainees who are evolving into autonomous practicing physicians — a process that requires balancing the responsibility of educating oneself with responsibility for direct patient care. During this evolution, residents must focus on both education and service.
To protect residents from such transgressions and provide oversight to residency programs, the Accreditation Council for Graduate Medical Education (ACGME) conducts an annual survey in which residents evaluate their training environments. Rather than probing residents for evidence of excessive scut work, however, the ACGME asks, “How often has your clinical education been compromised by excessive service obligations?,” with responses on a scale ranging from “not at all/never” to “extremely often.” The ACGME reports that on the 2007–2008 resident survey, this item had the highest rate of responses considered to indicate a program's noncompliance with council expectations.3 The council's chosen phrasing casts service in clear opposition to education. The survey is important because the data contribute to training programs' evaluations, and negative reviews regarding service can affect the ACGME's assessment of program quality……

But the ACGME survey raises numerous unanswered questions. Is it appropriate to focus on residents' personal interpretations of the terms “service” and “education”? How do residents define service? Does their definition align with those used by practicing clinicians and experienced educators (or by the Arnold P. Gold Foundation)? What happens if trainees and those responsible for their training have incongruent expectations for the role of service in medical training?.......
• A hematology resident is asked to consult about a patient scheduled for elective surgery who was incidentally found to have mild coagulation abnormalities. The resident has performed several other consultations this month for similar indications.
• A surgical resident is asked to dictate命令 口授 指定 a letter to a referring physician about a patient seen in the surgical clinic. The attending surgeon asks the resident to modify the letter's recommendations, and the resident must revise the dictation.
• After participating in a cardiac resuscitation on an inpatient unit, a pediatrics resident is asked to enter into the patient record orders for the various medications used.
• A family practice resident misses a teaching conference in order to see her last clinic patient, who arrives late because of transportation problems……..
How can we ensure that medical trainees view service as an avenue to enhancing their learning, rather than a threat to it? First, we recommend that medical educators openly and frequently reaffirm that service is an explicit aim of GME….
….. Over the past decade, many medical educators have worked to optimize the educational value of residency and protect trainees from engaging in menial奴僕的 activities from which they do not learn. As such reform continues, however, it risks going too far and sacrificing certain essential educational experiences that can emerge from service activities, as well as the opportunity to teach trainees about service's importance to the profession. As we train future physicians, we should convey the message that service to patients is fundamental to our professional role and an invaluable mechanism for learning.


The 2011 Duty-Hour Requirements — A Survey of Residency Program Directors
N Engl J Med 2013; 368:694-697February 21, 2013DOI: 10.1056/NEJMp1214483
美國IOM(Institute Of Medicine)在2009年公布ACGME的調查報告,重點在要求有"Fatigue"的課程安排,至於縮減駐院醫師工時(Duty hrs.),是否有關病人安全,要在2014年可能有結果?!........

In 2010, the Accreditation Council for Graduate Medical Education (ACGME) released new Common Program Requirements designed to improve patient safety as well as resident education and quality of life.1 These rules, which went into effect in July 2011 and introduced additional regulations related to duty hours and resident supervision, have already inspired considerable debate. In studies conducted before implementation, program directors and residents expressed mixed feelings about the potential effects of the new standards.2,3 Although program directors supported the 80-hour workweek, the maximum frequency of in-house call, and mandatory off-duty time, they opposed limiting first-year residents to 16-hour shifts.2 Residents expressed greater concern than program directors, fearing potential negative effects on quality of care, as well as resident education, experience, and preparedness for senior roles. The quality of life for residents was the only factor that they predicted might improve.3
Perhaps our most important finding is the strongly negative response to the 16-hour shift limitation for first-year residents, which mirrors that of earlier surveys.2-4 As the most junior physicians in the hospital, interns may be the most susceptible to fatigue and errors due to inexperience. Yet residents and program directors do not report that interns are less fatigued or working fewer total hours…..
…. Whereas most program directors approved of nearly all individual duty-hours standards, less than half expressed overall approval of the 2011 Common Program Requirements. This discrepancy may be due to the perceived negative effects on residents' education and accountability (“ownership” of patients) and perhaps also due to the increased workload the requirements have produced for program directors. Alternatively, the strong negative response to daily shift limitations, particularly the 16-hour limit for interns, may outweigh the positive response to the other standards, swaying overall sentiment. Finally, program directors may simply believe that there are too many regulations, an opinion expressed by 68.3% of respondents.
Although the ACGME remains committed to self-regulation of residency working conditions,5 our findings highlight the problem of applying a common standard to more than 100,000 resident physicians in the United States. Residents and program directors responding to national surveys since the implementation of the 2011 requirements report that the standards have had a substantial effect on the quality of residency training and residents' preparation to take on more advanced, supervisory roles. They agree that transitions of care have increased while continuity of care has decreased and that there has been no improvement in patient safety or the quality of care provided in U.S. teaching hospitals. Specialty-specific responses, however, suggest that there are fundamental differences in training expectations among disciplines, the most important of which are manifest in the transition from junior to senior resident.
……We believe that individual residency-review committees should develop rules to ensure that graduated responsibility is afforded in a safe and specialty-specific manner, while improving residents' education and quality of life as well as patient care. We also think it would be helpful to survey residents and program directors regularly to assess the effects of ACGME regulations on educational experience, achievement of milestones, competency for independent practice at graduation, life of trainees, and effects on patient care. More detailed study of the effects of fatigue and work hours on patient outcomes, “near misses,” and medical errors is also warranted. The results of these studies should be considered in future revisions of the Common Program Requirements and in the implementation of the Next Accreditation System.


The Step 2 Clinical Skills Exam — A Poor Value Proposition
Elmer Philip Lehman, IV, M.D., M.P.P., and Jason Ross Guercio, M.D., M.B.A.
N Engl J Med 2013; 368:889-891March 7, 2013DOI: 10.1056/NEJMp1213760
為甚麼會有"鮭魚返鄉”—尤奇是”來來—台大,去去去—美國的”-- 台灣人羨慕的美國?!
Efforts to minimize the regulatory and administrative burden in U.S. health care have never been greater. Stakeholders, including physicians, increasingly focus on eliminating waste and reducing costs in these areas to maximize the value and efficiency of care. One regulatory domain that deserves greater scrutiny in this context is medical licensure………..
For example, the National Board of Medical Examiners (NBME) and the Federation of State Medical Boards (FSMB) mandate the purchase of four licensing products by medical students and resident physicians over the course of their training. This three-step series of examinations is known as the United States Medical Licensing Examination (USMLE) and is jointly administered by the NBME and FSMB. The second exam, Step 2, is itself a two-part test administered in two sittings. One component, Step 2 Clinical Knowledge, is a multiple-choice exam; the other, Step 2 Clinical Skills (CS), is a day-long evaluation of clinical skills that takes place at one of five standardized-testing centers in the United States. Given the pass rates among examinees and the exam's cost, we believe that Step 2 CS provides a poor return on investment and little appreciable value to the U.S. health care system — and should therefore be eliminated.
The NBME and the FSMB reap impressive revenues from the administration of Step 2 CS. Using the most recent data available, we calculate that the cost of this test to U.S. and Canadian examinees is at least $20.4 million per year, given that 17,852 first-time examinees took the test in 2011 at a per-examinee cost of $1,140 (see tableFinancial Analysis of the USMLE Step 2 Clinical Skills Exam.)……..