After the tragic death of a young woman named Libby Zion in a New York Hospital, resident duty hour (RDH) restrictions were introduced in this state. An investigation ruled that lack of supervision, the resident's lack of familiarity with this woman's complex diagnosis and resident fatigue were contributing factors in the tragic outcome. In July 2003, the Accreditation Council for Graduate Medical Education (ACGME) mandated an 80-hour duty limit on residents , averaged over a 4-week period. In 2011, the ACGME mandated 16-hour duty periods for first year residents whereas the province of Quebec instituted 16-hour periods for all in-house residents in 2012. The stated goals of duty hour limitations were to improve patient safety , resident well-being, and education.1 patient outcomes .2 3 4 , 5
In March 2012, the Royal College of Physicians and Surgeons of Canada undertook a project to develop a pan-Canadian consensus on issues related to RDH. A national steering committee was struck and this committee further created 6 expert working groups. Recognizing that surgical training is unique in many aspects and that there have been significant obstacles related to the implementation of RDH in surgery, a specific working group entitled Special Considerations for Procedural and Surgical Disciplines was created. The National Steering Committee's full report is published elsewhere (www.residentdutyhours.ca 5
METHODS
Study Selection
A systematic review (1980–2013) was executed using indexed databases CINAHL, Cochrane Databases, Embase, Medline, and Scopus to identify pertinent articles relating to RDH restrictions with a focus on identifying articles that addressed the 2011 ACGME regulation and Quebec arbitration. Search terms were developed and revised by experts in surgical education . Predetermined eligibility criteria were used to eliminate articles beyond the scope of this review. Articles were included if the research focus was related to the impact of RDH restrictions on surgical resident well-being, education, and/or patient safety . Articles were also included if they addressed heterogeneity across different residency training programs and the varying impacts of RDH on different fields of health care. All abstracts and titles were reviewed by 2 members of the research team for inclusion in review (K.D. and I.K.). To ensure the comprehensive inclusion of high-quality literature on this topic, additional articles identified from hand searching of references and recommendations from content experts were added (Fig. 1 ).
FIGURE 1: Study selection and inclusion criteria.
Data Abstraction and Analysis
Quantitative and qualitative data extractions were performed independently by 2 members of the research team for all studies meeting the inclusion criteria. If consensus could not be reached, disputes were resolved by a third member of the research team (N.A.). The quality of the articles was assessed using the GRADE guidelines.6 high to very low , based on the level of confidence in the effect estimate. Attributions for consideration of high quality included multicentre designs, high volume of participants (>100), and control groups and that of low quality included unvalidated surveys and single institutional studies.
Extracted data were tabulated and examined for interpretation. Articles identified as moderate and high quality were analyzed separately. Articles graded as low or very low quality were not included in our overall analysis to maintain the integrity of the results. All articles examining 16-hour and night float shifts were analyzed and reported separately to determine the effects of more recent changes. Major findings for patient safety , resident well-being, and education were divided into actual and perceived impact. The term “unclear” was used to categorize studies that reported contradictory results or when the abstractors were unable to draw firm conclusions from the article.
Qualitative analysis was completed using the grounded theory approach. Open and axial coding was executed to capture themes from articles relevant to the 3 areas identified as sensitive to RDH restrictions: patient safety , resident well-being, and education. Themes were tabulated and refined. Qualitative themes are reported to add context to the quantitative data. Detailed results of the qualitative review will be reported separately.
Statistical Analysis
Articles that examined mortality data were combined in a random-effects meta-analysis to evaluate the impact of RDH on patient outcomes . The analysis was conducted in the statistical program R using the metafor package.7 , 8
RESULTS
A total of 709 articles were identified from indexed sources (CINAHL: 50, Cochrane Databases: 4, Embase: 203, Medline: 301, Scopus: 151). After the review of abstracts, full articles, suggested papers from content experts, and hand searching of references 135 articles were identified as eligible for data analysis (Fig. 1 ).
Study Characteristics
Ninety-five percent (128) of the studies were conducted in the United States or Canada, with 53% of these being multicentre (Table 1 ). General surgery was the most commonly studied discipline, comprising half of all studies. The primary study designs were surveys (61, 45%), interventional studies, with the intervention being the implementation of RDH restrictions (52, 39%) and observational studies (8, 6%). Only 1 article used a randomized controlled trial to examine the impact of duty hour restrictions (1%). Overall study objectives were to evaluate the impact of duty hour restrictions on resident education (101, 75%), patient safety (79, 59%), and resident wellness (48, 36%). Nine articles (7%) specifically compared the effect of RDH on training in various specialties. Fifty-eight percent of articles were graded as low or very low quality (N = 78) and 42% of studies were graded as moderate or high quality (N = 57).
TABLE 1: Characteristics of Articles (N = 135)
Major findings of articles with respect to the impact of duty hour restrictions on patient safety , resident well-being, and education can be listed as follows (Table 2 ).
TABLE 2: Summary of Effect of RDH Restrictions on Patient Safety and Educational Outcomes for Studies Graded as Moderate-High Quality, and for Studies Focusing on 16-Hour Duty Maximum and/or Night Float Systems
Section 1: Effect of RDH Restrictions Including 2003, 2011 ACGME Restrictions and the European Working Time Directive, From 57 Moderate to High Quality Studies
Patient Safety .patient safety ; 8 (30%) of these reported worsened patient safety outcomes (morbidity and mortality) as a result of duty hour restrictions.9–16 17–21 13 22–34 patient safety , 6 (67%) reported a decrease in quality of care,35–40 2 41 , 42 patient safety is inconclusive, but perceptions of health care professionals suggest negative outcomes.
Resident Well-being. Of the 57 articles considered moderate to high quality, 9 (16%) examined resident wellness . Five (71%) reported that duty hour restrictions had improved resident wellness 20 , 24 , 43–45 2 34 , 37 Burnout Inventory. Of the 7 articles evaluating perception of wellness, 4 (57%) reported improvement after RDH24 , 42 , 44 3 37 , 39 , 45 resident wellness .
Resident Education. Thirty-three (58%) articles graded as moderate to high quality examined resident education. Thirteen (48%) of these reported that educational outcomes were worsened after the implementation of RDH38 , 40 , 46–56 11 22 , 24 , 26 , 32 , 45 , 57–62 44 36 , 38–40 4 35 , 37 , 42 , 61 43
Section 2: Effect of the 16-Hour Duty Maximums on Patient Safety , Resident Well-being and Educational Outcomes From 17 Articles
Seventeen studies evaluated the impact of 16-hour duty maximums; 11 studies were low quality, 6 were moderate to high quality (Table 2 ).
Patient Safety .patient safety . Two articles objectively analyzed the impact (eg, examined morbidity and mortality rates), 1 study had unclear results38 34 residents ' perceptions of the impact of 16-hour duty maximum on patient safety , 11 (79%) reported that patient safety has declined,4 , 36–38 , 63–69 70 , 71 1 72 patient safety is inconclusive, but the perceived impact suggests patient safety has declined. Decreased continuity of care and increased number of handovers were themes identified from the qualitative review as causes for a decline in patient outcomes after duty hour restrictions.
Resident Wellness , Fatigue, and Burnout .resident wellness ; 2 articles using validated measures (eg, Maslach Burnout Inventory) concluded there has been no significant change. Eight articles examined the perceived impact; 3 (38%) reported improvement,64 , 70 , 72 67 37 3 4 , 65 , 71 71
Resident Education. Fifteen articles evaluated impact of the 16-hour duty maximums on resident education; 2 objectively assessed the impact and concluded education was worse (eg, examination data and/or clinical performance).38 , 55 4 , 36 , 38 , 64–72 2 22 , 35 , 37 residents , increased patient handover, decreased operative exposure, and increased self-reported medical errors.
Section 3: Effect of Night Float Systems From 8 Studies
Our analysis of the 8 studies examining night float systems showed that there was an improvement in resident wellness reported in 1 study,43 38 , 43 2 patient safety (Table 2 ).29 , 38 resident wellness (N = 3 studies).43 , 73 , 74 patient outcomes 38 , 73 43 , 73
Section 4: Effect of 16-Hour Duty Maximums and Night Float Systems From 24 Studies
When considering the 24 articles examining both 16-hour duty maximums and night float systems, we found that 3 studies examined the effect of these call models on morbidity and mortality (Table 2 ).29 , 34 , 38 patient safety as a result of these changes to RDH. Concerning resident wellness , 1 of 3 studies reported an improvement,43 34 , 37 38 , 55 43 residents believed that their wellness had improved after 16-hour shift restrictions and/or the implementation of night float systems.43 , 64 , 70 , 72–74 4 , 36 , 38 , 64–72 73 patient safety ; 12 (75%) reported a perception of worsened patient outcomes ,4 , 35–38 , 64–69 , 73 patient safety .74
Figure 2 summarizes the findings from the 17 papers related to 16-hour duty maximums; 13 studies were surveys. The results of studies related to resident wellness and fatigue are heterogeneous with a few studies in each category. Six studies examined time in the OR and overall reported that there was decreased time in the OR (N = 5) as a result of RDH restrictions.4 , 35 , 37 , 55 , 68 patient safety and found a strong signal toward worsened patient outcomes (N = 10),4 , 35–37 , 64–69 patient outcomes . Fifteen studies examined education and training; 12 of these showed worsened outcomes4 , 36 , 38 , 55 , 65–68 , 70–72 3 35 , 37 , 69
FIGURE 2: Impact of 16-hour duty maximums in surgery (N = 17 studies).
Section 5: Effect of RDH Restrictions on Patient Mortality and Morbidity
Mortality. A Forest plot summarizing 13 studies examining the effect of RDH on patient mortality is presented in Figure 3 . Two population-based series demonstrate an increase in patient mortality.18 , 19
FIGURE 3: Forest plot describing the effect of RDH restrictions on patient mortality.
TABLE 3-a: Effect of RDH Restrictions on Postoperative Morbidity
TABLE 3-b: Effect of RDH Restrictions on Postoperative Morbidity
Morbidity. Fifteen studies examined the effect of RDH restrictions on postoperative morbidity and are summarized in Table 3 . Because of the heterogeneity of the manner in which complications reported, we were unable to conduct a meta-analysis related to these outcomes. Overall, there were 15 studies from which we could extract data; 6 studies reported increased patient-level morbidity as a result of RDH.10–14 , 21 25 17 , 20 15 , 19 3 5 , 22 , 29 18 10–13 , 21
DISCUSSION
We have completed a comprehensive review of the relevant literature related to RDH restrictions in surgery. This study has several limitations. These limitations are related to the heterogeneous nature of the studies, the various RDH restrictions imposed over varying time intervals, the clinical contexts in which they were conducted, and that for the vast majority of studies, randomization was not possible owing to the regulated nature of duty hours in most jurisdictions. In addition, although there are many areas of debate with respect to the impact of duty hour restrictions, this article focused on patient safety , resident wellness , and resident education. Unfortunately, other topics such as professionalism, impact on surgical faculty and costs associated with mitigating the impact of RDH restrictions was deemed outside the scope of this review. The large number of articles examining perceptions of RDH impact using unvalidated surveys reduces the validity of the findings; to mitigate this, the perceived impacts were reported separately. Most of these papers were categorized as low quality and therefore not included in our final results. Finally, it proved impossible to conduct a meaningful meta-analysis of the literature related to surgical complications because of the manner in which these data were collected and reported across studies. The authors instead chose to report their findings in tabular format.
Patient Safety One of the stated goals of RDH restrictions was to protect patients from the deleterious effects of physician fatigue. Although evidence demonstrating deficits in attention and hand-eye coordination after sleep deprivation suggest that physician fatigue could compromise patient safety , particularly for the surgical population, this contention has not been demonstrated to date.16 , 22 , 25–27 , 33 , 75–79 patient safety after the implementation of RDH restrictions. A recently published, high-level meta-analysis surveying the surgical literatures shows convincingly that there has been no improvement in patient safety as a result of RDH restrictions.25 Fig. 2 ). More recently, there is increasingly strong evidence that RDH restrictions could be associated with harm to patients.11 , 75 10–12 10 , 11 , 13 16 11 P = 0.86) but did change significantly in teaching hospitals (OR = 1.23; 95% CI: 1.00–1.50; P < 0.05). There were no differences in mortality rates between the hospitals across these time points. The increased complications were attributed to the increased handovers. The notion that increasing the frequency of handovers has negative impacts on patient safety has been substantiated by a number of other studies.63 , 76 , 80 Journal of Neurosurgery also suggested an increase in complications. The authors studied a prospectively collected divisional Morbidity and Mortality database. They showed that the morbidity rate increased from 70 to 89 per 1000 patients treated after institution of work-hour restrictions (P = 0.001). The morbidities that were deemed avoidable or possibly preventable increased from 56 to 66 per 1000 patients treated (P = 0.017).10 patient safety after the 2011 ACGME 16-hour duty limitations. More recent evidence studying the effect of 2011 ACGME regulations suggests a decrease in patient safety related to increased numbers of handovers and work compression.34 81 residents ' ability to observe the natural course of disease and recognize deviations from an expected trajectory and complications of surgery. It is imperative that surgeons are trained to recognize the early signs of postoperative problems and institute appropriate interventions. The development of surgical acumen and the management of complications of surgery require repeated exposures so that subtle variations in clinical presentations can be mastered.
Resident Wellness , Fatigue, and Burnout Review of the literature pertaining to the change in RDH restrictions in surgery shows an improvement in resident well-being, fatigue, and burnout after the implementation of the 80-hour workweek and coincident with the 2003 ACGME regulations. However, the anticipated improvements in resident wellness , physical or occupational health, have not been consistently realized from subsequent regulations, such as the 2011 ACGME stipulations of 16-hour in-house duty maximums for first-year residents . A longitudinal cohort study undertaken by Sen et al34 residents from all specialties showed that 48% of respondents disapprove of 16-hour call maximums and only 22% of respondents supported the move to 16-hour duty in-house call maximums. The restrictions were perceived as detrimental to resident quality of life, education, and engagement with their supervisor. The residents ' survey responses suggest an improved quality of life for interns; however, quality of life for senior residents seems to suffer in the new paradigm. Interns also reported a decreased sense of readiness for more senior roles, raising a concern that 2011 duty hour reforms could result in prolongation of an already lengthy training.71 , 72 residents training under the 16-hour duty maximum regulations. Participants reported a significant negative effect on quality of life in their first year of training, a lack of continuity of care, exposure to supervisors and operative cases.37 34 residents experienced a paradoxical increased sense of fatigue and felt that their education was compromised as a result of 16-hour duty maximums. In addition to residents reporting feeling more fatigued, they also reported that they could not master surgical skills and perceived a decline in the quality of patient care they provided. Seventy percent of residents reported feeling disconnected from their service and that their mentoring relationship with faculty was compromised. Sixteen hour in house call maximums resulted in increased rates of burnout , isolation, as well as reduced morale among surgical trainees.67
Night, evening, rotating, and irregular shifts may also be associated with an elevated risk of workplace injuries and elevated rates of burnout . Shift work in general is associated with increased preterm labor, depression, weight gain, increased rates of injury and burnout and has been classified as a class I carcinogen by the World Health Organization.82 residents training under traditional 24-hour call models.83 84 residents may not necessarily have to equate with continuous wakefulness. Rest periods and protected sleep time that respects circadian physiology could improve resident fatigue and professional satisfaction, whereas preserving their access to educational opportunities and preserving patient safety . Night float systems alternate at weekly intervals as per the ACGME guidelines, causing not only a disruption in one's internal balance but creating a cycle where a resident may not have sufficient time to recover from the disruption before being exposed again to a 12-hour shift. Residents who adhere to traditional 24-hours call schedules may be more likely overall to experience relatively normal sleep patterns with deep sleep occurring at night. Thus far, it seems the recent trend toward night float and shift work has not yielded the desired result of more rested and professionally satisfied surgical residents .
Education and Training
Overall, of the 15 studies examining the effect of 16-hour duty maximums, none showed improvements in educational outcomes after the implementation of RDH restrictions. The majority of studies showed worsening of outcomes, whereas a few studies showed no change. Studies related to RDH restriction in education showed that overall the total numbers of operations performed during residency have decreased slightly. However, there has been a proportionately greater decrease in the volume of emergency surgical procedures performed. Furthermore, the residents ' role in the OR has changed over the last decade, with a significant decline in the numbers of cases reported as first assistant and as teaching assistant.51 residents to develop and demonstrate surgical mastery.51 residents , Schwartz et al55
The mastery of procedural components of surgery requires time on task in a mentored environment and with graduated responsibility. Specifically, achieving mastery of complex technical tasks requires deliberate practice. Some authors suggest that 10,000 hours of deliberate practice may be required.85 , 86 residents to identify deficiencies, address weaknesses, or provide meaningful evaluation. This observation is especially true for night-float rotations where exposure to teaching faculty can be extremely variable, random, and often brief.87 residents as they are feeling less prepared to assume the PGY2 role.71
Simulation has emerged as an important adjunct to training for specific types of skills. It can prepare learners for laparoscopic, endoscopic, and endovascular procedures through use of geometric exercises, which can accustom them to the 2 dimensional environment, thus improving hand eye coordination and instrument handling. Well-designed simulation curricula for these types of procedures result in greater ease with routine parts of the operation and can decrease time to achieve competence and entry into practice.88 89 patient outcomes remains unknown. Simulation for open surgery is useful to assist residents to learn the repetitive parts of operations (eg, practicing a stapled bowel anastomosis using porcine material). These motor skills then become more “automatic,” allowing learners to focus on anatomy, pathology, and judgment when they are in the OR. However, relying on simulation to learn clinical reasoning, intraoperative decision-making, or refining sophisticated surgical techniques, especially for open surgery, is not feasible. Simulation models lack fidelity to human anatomy and tissues and are ill equipped to accommodate for variation, unexpected findings, and abnormal or diseased anatomy. Simulation training is best thought of as preparatory for residents ' participation in the OR, as skills beyond the fundamental level in open surgery and accommodation to the 2 dimensional environment for laparoscopic procedures are better learned in the OR under the guidance and coaching of an experienced mentor.
Perhaps most concerning is the trend toward increased failure rates on the oral component of the various surgical board examinations. Although correlation does not imply causation, as many factors are involved in the outcome of board examinations, the American Board of Thoracic Surgery reported that over the last decade there has been a nearly linear increase in the failure rate of candidates, with 35% of trainees being unsuccessful in 2012, compared with 12% in 2003.53 52 90
Trainees' involvement in emergency operations is important for the development of surgical judgement and competence. Residents learn from their integral involvement in patient care about the evolution of surgical diagnoses; when to operate, how much diagnostic accuracy is sufficient, and perhaps most importantly, to recognize and manage surgical complications. Major surgical complications are relatively infrequent, but they are serious. Rare presentations and infrequent complications of surgery require greater flexibility in resident scheduling, so that residents may benefit from these exposures, as expertise in these areas remains tied to experiences nested in the clinical environment. These aspects of surgical acumen are an essential part of professional maturation and require time on task. As emphasized in a recent commentary in the New England Journal of Medicine by Kesselheim et al. education and service are inextricably linked and the current focus on “duty hours” as an isolated consideration may undermine the overarching objective of postgraduate medical training.77
2011 ACGME Restrictions—16-Hour Duty Shift Maximums for Surgical Residents
Review of the 17 studies that focused on assessing the impact of the 16-hour duty maximums showed a trend toward an overall negative impact in surgical training. Fargen et al65 residents across the United States and Puerto Rico that 83% of respondents disagreed with, or strongly disagreed with 16-hour duty maximums for PGY1 residents . De Martino et al64 resident wellness .70 residents at this time. Implementation of these RDH restrictions should be anticipated to result in prolongation of an already lengthy training duration and potential risk to patients, without tangible benefits to resident wellness .
Solutions to Improve Resident Wellness
Streamlining Resident Workflow and Investment in Wellness Resources
Residency systems have created expectations in teaching centers that the “doctor (aka resident) is always around.” This phenomenon dates back to the origins of the term “Resident.” Perhaps it is time to step back and reconsider the current role and purpose of surgical residency. Residents are present in teaching hospitals to learn about and deliver patient care. Their time and energy should be preserved to participate in patient evaluations, decision making, and operating. Surgical training needs to be more efficient. Other members of the health care team, such as physician assistants, nurse practitioners, respiratory therapists, pharmacists, phlebotomists, physiotherapists, and social workers, if correctly deployed could alleviate some of the “nonphysician” functions that currently distract residents from focusing their time in OR, management of ill patients, ambulatory clinics, academic rounds, and structured curricula.11 , 91 residents ' professional satisfaction and sense of wellness. Additional strategies to alleviate fatigue and prevent burnout include improved opportunities for sleep while on call as was recommended in the 2009 Institute of Medicine report. These solutions more readily respect circadian physiology than the current trend toward shift work and night float systems.92 , 93 residents and faculty, when appropriate, would alleviate resident workload and improve patient safety .94
Expansion of OR resources and acute care surgery teams may be necessary in certain settings to better ensure urgent operative cases are completed during daytime hours when feasible, leaving overnight OR resources for patients who present during the evening and night with life, limb, or vision threatening surgical diagnoses.95 , 96 residents ' professionalization.
Expansion of Wellness Resources and Implementation of Wellness Programs
Physicians, and perhaps to a greater extent surgeons, have long ignored our own health. This phenomenon in part is related to our professionalization and societal expectations, but it is also connected to the reality that every single one of our patients at any given moment is much worse off than the treating doctor. For the resident on a ward of cancer, trauma, sepsis, or burn patients, prioritizing one's own health is nearly impossible. Structural changes are required to accommodate this reality and enable residents to attend to their own physical and emotional well-being when necessary. One of the key recommendations in the Royal College of Physicians and Surgeons of Canada National Steering Committee report is to move the current discussion away from one that is focused solely on RDH and includes institutional strategies that enable fatigue mitigation and management, rather than relying only on externally imposed RDH limits.5 burnout . Wellness programs are defined by a combination of active and passive initiatives targeting the various domains of physical, mental, social, and intellectual wellness and have been shown to be effective, inexpensive, and well received by trainees.97–99
CONCLUSIONS
Systematic review of the literature related to RDH restrictions in surgery shows that there were benefits to resident wellness realized from 2003 ACGME regulations limiting RDH to 80 hours per week. However, there seems to be some concern for increased morbidity and mortality rates in high-acuity patients as a result of the 2003 and to a greater extent the 2011 ACGME regulations.11 , 12 , 20 residents in the United States and all in-house residents in the province of Quebec showed that there may be little added benefit to residents ' wellness.67 patient outcomes may extend beyond the highest acuity patients in surgery, as residents perceive increased rates of medical errors as a result of 16-hour duty maximums. Equally concerning, we found no evidence for improved educational or training experiences as a result of 16-hour duty maximums. Rather, there seems to be consistent findings across many studies of increased patient handovers, poorer team integration, professional dissatisfaction, concern for maturation of clinical skills, and decreased time in the OR. Philibert et al100
Fatigue is potentially harmful, mitigating its effects while ensuring adequate training is essential. Strategies such as less than 24 hour shifts have failed to demonstrate a significant benefit to resident wellness and potentially deleterious consequences for patient and training outcomes.35 , 38 , 55 81 residents for schedules commonly encountered in the independent practice of that specialty. It is clear that a “one-size fits all” solution to the issue of RDH restrictions is not appropriate for all medical disciplines. A more tailored and discipline specific approach is required such that training objectives and patient outcomes are protected. This view has been supported by a pan-Canadian consensus process related to RDHs, led by the Royal College of Physicians and Surgeons in Canada.5 surgical education bodies including the American College of Surgeons, Division of Education and the Royal College of Surgeons of Edinburgh.3 , 101 resident wellness though fatigue mitigation strategies, screening and addressing resident burnout , as well as improving resident workflow to optimize resident sleep, supervision and minimize tasks unrelated to the provision of medically necessary care, and preserving access to key mentorship and high impact learning opportunities. An approach that centers on the training mandate of residencies and allows a degree of flexibility will be necessary if we wish to preserve robust educational and patient-level outcomes without further prolonging an already arduous and lengthy training experience. It is well time to reconsider the direction of RDH as it relates to surgical training, as the recent erosion of resident training time has not achieved the desired results. A broader dialogue beyond duty hours alone will yield a more satisfactory outcome for all stakeholders, and especially for surgical residents .
ACKNOWLEDGMENTS
The authors thank the National Steering Committee on RDHs and the Royal College of Physicians and Surgeons of Canada for their assistance in the completion of this project and especially Lisa Gorman and Sarah Taber. They also thank the following working group members for their inputs: Barbara Guido, Henry Broekhuyse, Joanne Carrier, David Steven, Douglas Hedden, Jefferson Wilson, Jean Francios Chevalier, Joel Werier, Pamela Chu, Piotr Blachut, Ravi Sidhu, Grace Yeung, and Mark Walsh.
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