Appropriateness in Health Care
This paper discusses the concept of appropriateness in health care and advances the following definition:
The Canadian Medical Association adopts the following definition for appropriateness in health care: It is the right care, provided by the right providers, to the right patient, in the right place, at the right time, resulting in optimal quality care.
Building on that definition it makes the following policy recommendations:
* Provinces and territories should work with providers to develop a comprehensive framework by which to assess the appropriateness of health care.
* Provinces and territories should work with providers to develop robust educational products on appropriateness in health care and to disseminate evidence-informed strategies for necessary changes in care processes.
* Provinces and territories should work with providers to put in place incentives to decrease the provision of marginally useful or unnecessary care.
As health systems struggle with the issue of sustainability and evidence that the quality of care is often sub-optimal, increasing attention is focused on the concept of appropriateness. A World Health Organization study published in 2000 described appropriateness as "a complex, fuzzy issue"1. Yet if the term is to be applied with benefit to health care systems, it demands definitional clarity. This policy document presents the Canadian Medical Association definition of appropriateness which addresses both quality and value. The roots of the definition are anchored in the evolution of Canadian health care over the last two decades. The document then considers the many issues confronting the operationalization of the term. It concludes that appropriateness can play a central role in positive health system transformation.
At the Canadian Medical Association General Council in 2013 the following resolution was adopted:
The Canadian Medical Association adopts the following definition for appropriateness in health care: It is the right care, provided by the right providers, to the right patient, in the right place, at the right time, resulting in optimal quality care.
This definition has five key components:
* right care is based on evidence for effectiveness and efficacy in the clinical literature and covers not only use but failure to use;
* right provider is based on ensuring the provider's scope of practice adequately meets but does not far exceed the skills and knowledge to deliver the care;
* right patient acknowledges that care choices must be matched to individual patient characteristics and preferences and must recognize the potential challenge of reconciling patient and practitioner perceptions;
* right venue emphasizes that some settings are better suited in terms of safety and efficiency to delivering a specific type of care than others;
* right time indicates care is delivered in a timely manner consistent with agreed upon bench marks.
It is essential to appreciate that the "right cost" is a consequence of providing the right care, that it is an outcome rather than an input. In other words, if all five components above are present, high quality care will have been delivered with the appropriate use of resources, that is, at the right cost. Equally, however, it should be cautioned that right cost may not necessarily be the affordable cost. For example, a new drug or imaging technology may offer small but demonstrable advantages over older practices, but at an enormous increase in cost. Some might argue that right care includes the use of the newer drug or technology, while others would contend the excessive opportunity costs must be taken into consideration such that the older practices remain the right care.
An Evolving Canadian Perspective from 1996 to 2013
In a pioneering paper from 1996 Lavis and Anderson wrote:
...there are two distinct types of appropriateness: appropriateness of a service and appropriateness of the setting in which care is provided. The differences between the two parallel the differences between two other concepts in health care: effectiveness and cost-containment...An appropriate service is one that is expected to do more good than harm for a patient with a given indication...The appropriateness of the setting in which care is provided is related to cost effectiveness2.
This very serviceable definition moved beyond a narrow clinical conception based solely on the therapeutic impact of an intervention on a patient, to broader contextual consideration focused on venue. Thus, for example, the care provided appropriately in a home-care setting might not be at all appropriate if given in a tertiary care hospital. Significantly, the authors added this important observation: "Setting is a proxy measure of the resources used to provide care"2. This sentence is an invitation to expand the original Lavis and Anderson definition to encompass other resources and inputs identified over the ensuing decades. Three elements are especially important.
Timeliness became an issue in Canadian health care just as the Lavis and Anderson paper appeared. In 1997 almost two-thirds of polled Canadians felt surgical wait times were excessive, up from just over half of respondents a year earlier3. By 2004 concern with wait times was sufficiently pervasive that when the federal government and the provinces concluded the First Ministers' Agreement, it included obligations to provide timely access to cancer care, cardiac care, diagnostic imaging, joint replacement and sight restoration4. These rapid developments indicate that timeliness was now considered an essential element in determining the appropriateness of care.
A second theme that became prominent in health care over the last two decades was the concept of patient-centredness. When the Canadian Medical Association released its widely endorsed Health Care Transformation in Canada in 2010, the first principle for reform was building a culture of patient-centred care. Succinctly put, this meant that "health care services are provided in a manner that works best for patients"5. To begin the process of operationalizing this concept CMA proposed a Charter for Patient-centred Care. Organized across seven domains, it included the importance of: allowing patients to participate fully in decisions about their care; respecting confidentiality of health records; and ensuring care provided is safe and appropriate. This sweeping vision underscores the fact that care which is not matched to the individual patient cannot be considered appropriate care.
A third significant development over the last two decades was heightened awareness of the importance of scopes of practice. This awareness arose in part from the emphasis placed on a team approach in newer models of primary care6, but also from the emergence of new professions such as physician assistants, and the expansion of scopes of practice for other professionals such as pharmacists7. As the same health care activity could increasingly be done by a wider range of health professionals, ensuring the best match between competence required and the service provided became an essential element to consider when defining appropriateness. Under-qualified practitioners could not deliver quality care, while overly-qualified providers were a poor use of scarce resources.
To summarize, as a recent scoping review suggested, for a complete conceptualization of appropriateness in 2013 it is necessary to add the right time, right patient and right provider to the previously articulated right care and right setting8.
Why Appropriateness Matters
The most frequent argument used to justify policy attention to appropriateness is health system cost. There is a wealth of evidence that inappropriate care - avoidable hospitalizations, for example, or alternative level of care patients in acute care beds - is wide spread in Canada9; eliminating this waste is critical to system sustainability. In Saskatchewan, for example, Regina and Saskatoon contracted in 2011 with private clinics to provide a list of 34 surgical procedures. Not only were wait times reduced, but costs were 26% lower in the surgical clinics than in hospitals for doing the same procedures10.
There is, however, an equally important issue pointing to the importance of ensuring appropriate care: sub-optimal health care quality. In the United States, for example, a study evaluated performance on 439 quality indicators for 30 acute and chronic conditions. Patients received 54.9% of recommended care, ranging from a high of 78.7% for senile cataracts to 10.5% for alcohol dependence11. A more recent Australian study used 522 quality indicators to assess care for 22 common conditions. Patients received clinically appropriate care in 57% of encounters, with a range from 90% for coronary artery disease to 13% for alcohol dependence12. While no comparable comprehensive data exist for Canada, it is unlikely the practices in our system depart significantly from peer nations. Focusing on appropriateness of care, then, is justified by both fiscal and quality concerns.
Methodology: the Challenge of Identifying Appropriateness
While there is a clear need to address appropriateness - in all its dimensions - the methods by which to assess the appropriateness of care are limited and, to date, have largely focused on the clinical aspect.
The most frequently used approach is the Rand/University of California Los Angeles (Rand) method. It provides panels of experts with relevant literature about a particular practice and facilitates iterative discussion and ranking of the possible indications for using the practice. Practices are labeled appropriate, equivocal or inappropriate13. A systematic review in 2012 found that for use on surgical procedures the method had good test-retest reliability, interpanel reliability and construct validity14. However, the method has been criticized for other short-comings: panels in different countries may reach different conclusions when reviewing the same evidence; validity can only be tested against instruments such as clinical practice guidelines that themselves may have a large expert opinion component2; Rand appropriateness ratings apply to an "average" patient, which cannot account for differences across individuals; and, finally, Rand ratings focus on appropriateness when a service is provided but does not encompass underuse, that is, failure to provide a service that would have been appropriate9.
The Rand method, while not perfect, is the most rigorous approach to determining clinical appropriateness yet devised. It has recently been suggested that a method based on extensive literature review can identify potentially ineffective or harmful practices; when applied to almost 6000 items in the Australian Medical Benefits Schedule, 156 were identified that may be inappropriate15. This method also presents challenges. For example, the authors of a study using Cochrane reviews to identify low-value practices note that the low-value label resulted mainly from a lack of randomized evidence for effectiveness16.
Assessing the appropriateness of care setting has focused almost exclusively on hospitals. Some diagnoses are known to be manageable in a community setting by primary care or specialty clinics. The rate of admissions for these ambulatory care sensitive conditions (ACSCs) - which fell from 459 per 100,000 population in 2001-02 to 320 per 100,00 in 2008-09 - is one way of gauging the appropriateness of the hospital as a care venue9. A second measure is the number of hospital patients who do not require either initial or prolonged treatment in an acute care setting. Proprietorial instruments such as the Appropriateness Evaluation Protocol (AEP)17or the InterQual Intensity of Service, Severity of Illness and Discharge Screen for Acute Care (ISD-AC)18 have been used to assess the appropriateness of hospital care for individual patients. While these instruments have been applied to Canadian hospital data19,20, there is a lack of consensus in the literature as to the reliability and utility of such tools21-23.
Benchmarks exist for appropriate wait times for some types of care in Canada through the work of the Wait Time Alliance4. These include: chronic pain, cancer care, cardiac care, digestive health care, emergency rooms, joint replacement, nuclear medicine, radiology, obstetrics and gynecology, pediatric surgery, plastic surgery, psychiatric illness, and sight restoration. The recommendations are based on evidence-informed expert opinion.
The other two domains of appropriateness - right patient, right provider - as yet have no objective tools by which to assess appropriateness.
Determining appropriateness demands a complex and time-consuming approach, and its operationalization faces a number of barriers.
The availability of some health care services may be subject to political influence which will over-ride appropriateness criteria. For example, recommendations to close smaller hospitals deemed to be redundant or inefficient may not be implemented for political reasons.
Patient expectations can challenge evidence-based appropriateness criteria. In a primary care setting, for instance, it may be difficult to persuade a patient with an ankle sprain that an x-ray is unlikely to be helpful. The insistence by the patient is compounded by an awareness of potential legal liability in the event that clinical judgment subsequently proves incorrect. Choosing Wisely Canada recommends physicians and patients become comfortable with evidence-informed conversations about potentially necessary care24.
Traditional clinical roles are difficult to revise in order to ensure that care is provided by the most appropriate health professional. This is especially true if existing funding silos are not realigned to reflect the desired change in practice patterns.
Finally, and perhaps most importantly, even if agreed upon appropriateness criteria are developed, holding practitioners accountable for their application in clinical practice is extremely difficult due to data issues25. Chart audits could be conducted to determine whether appropriateness criteria were met when specific practices were deployed, but this is not feasible on a large scale. Rates of use of some practices could be compared among peers from administrative data; however, variation in practice population might legitimately sustain practice variation. For diagnostic procedures it has been suggested that the percentage of negative results is an indicator of inappropriate use; however, most administrative claim databases would not include positive or negative test result data26. This data deficit must be addressed with health departments and regional health authorities.
There are several additional constraints on the use of the concept by health system managers.
First, the vast majority of practices have never been subject to the Rand or any other appropriateness assessment. Even for surgical procedures clinical appropriateness criteria exist for only 10 of the top 25 most common inpatient procedures and for 6 of the top 15 ambulatory procedures in the United States. Most studies are more than 5 years old27.
Second, while the notion is perhaps appealing to policy makers, it is incorrect to assume that high use of a practice equates with misuse: when high-use areas are compared to low use areas, the proportion of inappropriate use has consistently been shown to be no greater in the high-use regions28,29.
Finally, it is uncertain how large a saving can be realized from eliminating problematic clinical care. For example, a US study modeling the implementation of recommendations for primary care found that while a switch to preferentially prescribing generic drugs would save considerable resources, most of the other items on the list of questionable activities "are not major contributors to health care costs"30. What is important to emphasize is that even if dollars are not saved, by reducing inappropriate care better value will be realized for each dollar spent.
These methodological and other challenges31 notwithstanding, the Canadian Medical Association puts forward the following recommendations for operationalizing the concept of appropriateness and of clinical practice.
1. Provinces and territories should work with providers to develop a comprehensive framework by which to assess the appropriateness of health care.
Jurisdictions should develop a framework32 for identifying potentially inappropriate care, including under-use. This involves selecting criteria by which to identify and prioritize candidates for assessment; developing and applying a robust assessment methodology; and creating mechanisms to disseminate and apply the results. Frameworks must also include meaningful consideration of care venue, timeliness, patient preferences and provider scope of practice. International examples exist for some aspects of this exercise and should be adapted to jurisdictional circumstances. Necessarily, a framework will demand the collection of supporting data in a manner consistent with the following 2013 General Council resolution:
The Canadian Medical Association supports the development of data on health care delivery and patient outcomes to help the medical profession develop an appropriateness framework and associated accountability standards provided that patient and physician confidentiality is maintained.
2. Provinces and territories should work with providers to develop robust educational products on appropriateness in health care and to disseminate evidence-informed strategies for necessary changes in care processes.
Both trainees and practicing physicians should have access to education and guidance on the topic of appropriateness and on practices that are misused, under-used, or over-used. Appropriately designed continuing education has been shown to alter physician practice. Point of care guidance via the electronic medical record offers a further opportunity to alert clinicians to practices that should or should not be done in the course of a patient encounter33.
An initiative co-led by the Canadian Medical Association that is designed to educate the profession about the inappropriate over use of diagnostic and therapeutic interventions is Choosing Wisely Canada. The goal is to enhance quality of care and only secondarily to reduce unnecessary expenditures. It is an initiative consistent with the intent of two resolutions from the 2013 General Council:
The Canadian Medical Association will form a collaborative working group to develop specialty-specific lists of clinical tests/interventions and procedures for which benefits have generally not been shown to exceed the risks.
The Canadian Medical Association believes that fiscal benefits and cost savings of exercises in accountability and appropriateness in clinical care are a by-product rather than the primary focus of these exercises.
3. Provinces and territories should work with providers to put in place incentives to decrease the provision of marginally useful or unnecessary care.
Practitioners should be provided with incentives to eliminate inappropriate care. These incentives may be financial - delisting marginal activities or providing bonuses for achieving utilization targets for appropriate but under-used care. Any notional savings could also be flagged for reinvestment in the health system, for example, to enhance access. Giving physicians the capacity to participate in audit and feedback on their use of marginal practices in comparison to peers generally creates a personal incentive to avoid outlier status. Public reporting by group or institution may also move practice towards the mean30. In any such undertakings to address quality or costs through changes in practice behaviour it is essential that the medical profession play a key role. This critical point was captured in a 2013 General Council resolution:
The Canadian Medical Association will advocate for adequate physician input in the selection of evidence used to address costs and quality related to clinical practice variation.
When appropriateness is defined solely in terms of assessing the clinical benefit of care activities it can provide a plausible rational for "disinvestment in" or "delisting of" individual diagnostic or therapeutic interventions. However, such a narrow conceptualization of appropriateness cannot ensure that high quality care is provided with the optimal use of resources. To be truly useful in promoting quality and value appropriateness must be understood to mean the right care, provided by the right provider, to the right patient, in the right venue, at the right time.
Achieving these five components of health care will not be without significant challenges, beginning with definitions and moving on to complex discussions on methods of measurement. Indeed, it may prove an aspirational goal rather than a completely attainable reality. But if every encounter in the health system - a hospitalization, a visit to a primary care provider, an admission to home care - attempted to meet or approximate each of the five criteria for appropriateness, a major step towards optimal care and value will have been achieved across the continuum. Viewed in this way, appropriateness has the capacity to become an extraordinarily useful organizing concept for positive health care transformation in Canada.
Approved by CMA Board on December 06, 2014
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2. Lavis JN, Anderson GM. Appropriateness in health care delivery: definitions, measurement and policy implications. CMAJ. 1996;154(3):321-8.
3. Sanmartin C, Shortt SE, Barer ML, Sheps S, Lewis S, McDonald PW. Waiting for medical services in Canada: lots of heat, but little light. CMAJ. 2000;162(9):1305-10.
4. Wait Time Alliance. Working to Improve Wait Times Across Canada. Toronto: Wait Time Alliance; 2014. Available: http://www.waittimealliance.ca. (accessed April 18, 2013)
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6. Canadian Medical Association. CMA Policy: Achieving Patient-centred Collaborative Care. Ottawa: Canadian Medical Association; 2008.
7. Maxwell-Alleyne A, Farber A. Pharmacists' expanded scope of practice: Professional obligations for physicians and pharmacists working collaboratively. Ont Med Rev. 2013;80(4):17-9.
8. Sanmartin C, Murphy K, Choptain N, et al. Appropriateness of healthcare interventions: concepts and scoping of the published literature. Int J Technol Assess Health Care. 2008;24(3)342-9.
9. Canadian Institute for Health Information. Health Care in Canada 2010. Ottawa: CIHI; 2010.
10. MacKinnon J. Health Care Reform from the Cradle of Medicare. Ottawa: Macdonald-Laurier Institute; 2013.
11. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to adults in the United States. NEJM. 2003;348(26):2635-45.
12. Runciman WB, Hunt TD, Hannaford NA, et al. CareTrack: assessing the appropriateness of health care delivery in Australia. Med J Aust. 2012;197(2):100-5.
13. Brook RH, Chassin MR, Fink A, Solomon DH, Kosecoff J, Park RE. A method for the detailed assessment of the appropriateness of medical technologies. Int J Technol Assess Health Care. 1986;2(1):53-63.
14. Lawson EH, Gibbons MM, Ko CY, Shekelle PG. The appropriateness method has acceptable reliability and validity for assessing overuse and underuse of surgical procedures. J Clin Epidemiol. 2012;65(11):1133-43.
15. Elshaug AG, Watt AM, Mundy L, Willis CD. Over 150 potentially low-value health care practices: an Australian study. Med J Aust. 2012;197(10):556-60.
16. Garner S, Docherty M, Somner J, et al. Reducing ineffective practice: challenges in identifying low-value health care using Cochrane systematic reviews. J Health Serv Res Policy. 2013;18(1):6-12.
17. Gertman PM, Restuccia JD. The appropriateness evaluation protocol: a technique for assessing unnecessary days of hospital care. Med Care. 1981;19(8):855-71.
18. Mitus AJ. The birth of InterQual: evidence-based decision support criteria that helped change healthcare. Prof Case Manag. 2008;13(4):228-33.
19. DeCoster C, Roos NP, Carriere KC, Peterson S. Inappropriate hospital use by patients receiving care for medical conditions: targeting utilization review. CMAJ. 1997;157(7):889-96.
20. Flintoft VF, Williams JI, Williams RC, Basinski AS, Blackstien-Hirsch P, Naylor CD. The need for acute, subacute and nonacute care at 105 general hospital sites in Ontario. Joint Policy and Planning Committee Non-Acute Hospitalization Project Working Group. CMAJ . 1998;158(10):1289-96.
21. Kalant N, Berlinguet M, Diodati JG, Dragatakis L, Marcotte F. How valid are utilization review tools in assessing appropriate use of acute care beds? CMAJ. 2000;162(13):1809-13.
22. McDonagh MS, Smith DH, Goddard M. Measuring appropriate use of acute beds. A systematic review of methods and results. Health policy. 2000;53(3):157-84.
23. Vetter N. Inappropriately delayed discharge from hospital: what do we know? BMJ. 2003;326(7395):927-8.
24. Choosing Wisely Canada. Recent News. Ottawa: Choosing Wisely Canada; 2015. Available: www.choosingwiselycanada.org. (accessed Dec 2014)
25. Garner S, Littlejohns P. Disinvestment from low value clinical interventions: NICEly done? BMJ. 2011;343:d4519.
26. Baker DW, Qaseem A, Reynolds PP, Gardner LA, Schneider EC. Design and use of performance measures to decrease low-value services and achieve cost-conscious care. Ann Intern Med. 2013;158(1):55-9.
27. Lawson EH, Gibbons MM, Ingraham AM, Shekelle PG, Ko CY. Appropriateness criteria to assess variations in surgical procedure use in the United States. Arch Surg. 2011;146(12):1433-40.
28. Chassin MR, Kosecoff J, Park RE, et al. Does inappropriate use explain geographic variations in the use of health care services? A study of three procedures. JAMA. 1987;258(18):2533-7.
29. Keyhani S, Falk R, Bishop T, Howell E, Korenstein D. The relationship between geographic variations and overuse of healthcare services: a systematic review. Med care. 2012;50(3):257-61.
30. Kale MS, Bishop TF, Federman AD, Keyhani S. "Top 5" lists top $5 billion. Arch Intern Med. 2011;171(20):1856-8.
31. Elshaug AG, Hiller JE, Tunis SR, Moss JR. Challenges in Australian policy processes for disinvestment from existing, ineffective health care practices. Aust New Zealand Health Policy. 2007;4:23.
32. Elshaug AG, Moss JR, Littlejohns P, Karnon J, Merlin TL, Hiller JE. Identifying existing health care services that do not provide value for money. Med J Aust. 2009;190(5):269-73.
33. Shortt S GM, Gorbet S. Making medical practice safer: the role of public policy. Int J Risk Saf Med. 2010;22(3):159-68.
Health systems around the world are struggling with how to best meet the health needs of their populations. Health leaders speak with urgency about the need to improve the individual experience of care, improve the health of populations, and maximize return on investments. Physicians concur - they are continually focused on providing better care to their patients.
Concurrently, concerns over patient safety have arisen over the last two decades, rooted in studies of adverse events. The incidence of adverse events (AEs) in acute care hospitals has been reported in the United States (US),1,2,3 Australia,4 United Kingdom,5 and Canada.6 Between 5% and 20% of patients admitted to hospital experience one or more AEs; between 36.9% - 51% of these AEs are preventable; and AEs contribute billions of dollars through additional hospital stays as well as other costs to the system, patients and the broader society.7 Leape et al. maintain that more than two-thirds of AEs are preventable.8 These outcomes have prompted decision makers, policy makers and healthcare providers to examine contributing factors, including the increasingly complex health system and its impact on the well-being of providers.
Patient safety and physician well-being are the key drivers leading to restrictions on resident and/or physician duty hours aimed at reducing their fatigue. The European Working Time Directive (EWTD) was first established in 1993 to place limits on all workers' hours throughout Europe under the umbrella of health and safety legislation. That directive included physicians but excluded doctors in training. In 2000, a new directive passed to include the "junior doctor" constituency accompanied by a requirement that by 2009 all health systems in the European Union limit resident work to a maximum of 48 hours averaged per week. The intention was to improve the working lives of doctors in training and to increase patient safety. A systematic review on the impact of the EWTD on postgraduate medical training, patient safety, or clinical outcomes found studies to be of poor quality with conflicting results.9
In 2003, the Accreditation Council for Graduate Medical Education (ACGME) in the US adopted a set of duty hour regulations for physicians in training. The ACGME issued revised regulations that went into effect in July 2011, reflecting the recommendations of a 2008 Institute of Medicine report Resident Duty Hours: Enhancing Sleep, Supervision, and Safety, calling for elimination of extended duty shifts (more than 16 hours) for first year residents, increasing days off, improving sleep hygiene by reducing night duty and providing more scheduled sleep breaks, and increasing oversight by more senior physicians.10 The Institute of Medicine's report bases its recommendations on the growing body of research linking clinician fatigue and error.
In 2013, the National Steering Committee on Resident Duty Hours released Canada's first comprehensive, collaborative and evidence-based report on fatigue and duty hours for Canada's approximately 12,000 residents. The Committee stresses that a comprehensive approach is necessary in order to enhance safety and wellness outcomes. Fatigue risk management is a predominant theme in the recommendations.
Fatigue management systems are in place in other sectors/industries that have a low threshold for adverse outcomes including aviation, transportation, and the Department of National Defence. In 2010, the Canadian Nurses Association released a position statement Taking Action on Nurse Fatigue that speaks to system, organizational and individual level responsibilities of registered nurses.
There are currently no specific policies in Canada for physicians in practice with respect to fatigue management. Given the heterogeneity of medical practice (i.e. various specialties) and of the practice settings (i.e. rural and remote versus urban, clinic versus hospital, etc.), the solutions emanating from a fatigue management policy may be different - one size will not fit all.
Impact of Physician Fatigue
Sleep deprivation is the condition of not having enough sleep and can be either chronic or acute. It impairs cognitive and behavioural performance. "Sleep is required for the consolidation of learning and for the optimal performance of cognitive tasks. Studies of sleep deprivation have shown that one night without sleep negatively affects the performance of specific higher cognitive functions of the prefrontal cortex and can cause impairment in attention, memory, judgment, and problem solving."(p. 1841)11 A seminal study by Williamson and Feyer found that after 17-19 hours without sleep, performance on some cognitive and motor performance tests was equivalent or worse than that at a blood alcohol concentration (BAC) of 0.05%.12 Wakefulness for 24 hours is equivalent to a blood alcohol level of 0.10%.13
A chronic sleep-restricted state can cause fatigue, which is a subjective feeling of tiredness, lack of energy and motivation. A large body of research exists linking sleep deprivation/fatigue, performance and adverse patient outcomes, particularly for medical residents. 14,15,16,17,18,19, 20, 21,22, 23,24 However, literature on the impact on performance varies based on a number of factors. There are significant inter-individual differences in the global response to sleep loss, as well as significant intra-individual variations in the degree to which different domains of neurobehavioral function (e.g., vigilance, subjective sleepiness, and cognitive performance) are affected. Inter-individual differences are not merely a consequence of variations in sleep history. Rather, they involve trait-like differential vulnerability to impairment from sleep loss. 25
Evidence suggests an inconclusive relationship between duty hour reductions (primarily those implemented in the US) and patient safety, suggesting that restrictions on consecutive duty hours have not had the anticipated impact on this crucial outcome as anticipated.26 Several large studies have revealed only neutral or slightly improved patient mortality and other clinical parameters since implementation of the ACGME work hour limits in the US.27,28, 29,30 In complex and ever changing health systems, it is difficult to isolate the impact of restricted duty hours alone.
Research on the effects of practicing physician sleep deprivation and extended work shifts on clinical outcomes is limited and inconclusive.31, 32
The issue of physician fatigue is complex, and is affected by much more than duty hours. Other contributing factors affect performance including work patterns, individual response to sleep loss, experience of the worker, the context of which sleep deprivation is necessary, hours of actual sleep, patient volume, patient turnover and patient acuity, environmental factors, personal stressors, workload, etc. Limiting work hours alone is not sufficient to address sleep deprivation among physicians. Reduced or disturbed periods of sleep, more consecutive days or nights of work, shift variability, and the volume of work all increase fatigue and thus can contribute to errors.
One of the biggest concerns with a fatigue management strategy is continuity of care, linked to the number of transfers of care (handover) among providers. Transfers of care inevitably increase in an environment of work hour limitations.33, 34 Handovers are considered critical moments in the continuity of patient care and have been identified as a significant source of hospital errors, often related to poor communication. There is a growing body of literature on how to do these well and how to teach this well. This is an important skill for physicians in the context of a fatigue management strategy: "Standardization of the handover process has been linked to a reduction in the number of errors related to information transfers. In addition, effective mechanisms for the transfer of information at transition points have been recognized as patient safety enablers."35
Provider well-being (physical, mental, occupational) is linked to system performance and patient outcomes. It is affected by fatigue and work patterns including night shift and extended hours. Comprehensive, systematic reviews of the health effects of on-call work in 2004 showed that nighttime work interrupted sleep patterns, aggravated underlying medical conditions, and increased the risk of cardiovascular, gastrointestinal, and reproductive dysfunction.36,37.38 Other research suggests an elevated risk of breast cancer,39,40 prostate cancer,41 colorectal cancer,42 asthma43, diabetes,44 and epilepsy45 for shift workers. Disruption of the body's circadian rhythms is thought to be one of the main pathways for adverse health effects from shift work, particularly for work schedules that involve night work.
Given that 24-hour work is unavoidable in various industries, including healthcare, researchers have evaluated different shift schedules designed to reduce some of the negative health effects of working at night. Optimal shift schedules are aligned as much as possible with the circadian rhythm, promote adaptation of the circadian rhythm with shift work, reflect workers' needs and preferences, and meet organizational or productivity requirements. The following interventions appear to have the most beneficial effects on the health of shift workers:46
* Schedule changes including changing from backward (counterclockwise) to forward (clockwise) rotation, from eight hour to 12 hour shifts, and flexible working conditions, self-scheduling, and ergonomic shift scheduling principles
* Controlled exposure to light and day;
* Behavioural approaches such as physical activity, scheduled naps and education about sleep strategies; and
* Use of pharmacotherapy (i.e. caffeine and melatonin) to promote sleep, wakefulness, or adaptation
Sleep deprivation and on-call shifts consistently point to deterioration of mood resulting in depression, anger, anxiety, hostility, and decreased vigilance.47 ,48, 49 A Canadian study found that shift workers reported significantly higher burnout, emotional exhaustion, job stress and psychosomatic health problems (e.g. headaches, upset stomach, difficulty falling asleep) than workers on a regular day schedule.50 Prolonged duty hours by residents has been found to contribute to marital problems, pregnancy complications, depression, suicide and substance abuse,51 as well as serious conflicts with attending physicians, other residents, and nurses, in addition to increased alcohol use and instances of unethical behaviour.52 Surprisingly however, the abolishment of 24-hour continuous medical call duty for general surgery residents at one facility in Quebec was associated with self-reported poorer quality of life.53
In contrast to other recommendations on the health benefits of 8 hr shifts, the risk of a work safety incident increases markedly after more than eight hours on duty. The risk in the twelfth hour is almost double than in the eighth hour (and more than double the average risk over the first eight hours on duty).54 Extended work duration and nighttime work by interns is associated with an increased risk of reported percutaneous injuries (PIs).55 Fatigue was reported more often as a contributing factor for nighttime compared with daytime injuries. Fatigue was also more commonly reported as a contributing factor to PIs that occurred after extended work than those that occurred after non-extended work.56 Other research found that residents were most exposed to blood-borne pathogens through needle punctures or cuts during overnight duty periods.57
Health care facilities that have physicians working in them have a role in supporting and promoting provider well-being, including providing enablers of extending and continuing resiliency such as nutritious food, on call rooms, appropriate numbers of staff, locums, etc. They also have a role in working jointly and collaboratively with physicians to ensure that on-call schedules do not place work demands on individual physicians that prevent the physicians from providing safe patient care and service coverage. For example, research with emergency physicians suggests that a nap at 3 AM improves performance in physicians and nurses at 7:30 AM compared to a no-nap condition despite the fact that memory temporarily worsened immediately after the nap.58
Individual resilience, intergenerational differences, illness-related issues, as well as family commitments also need to be considered. Physicians should also be encouraged to take the necessary time to rest and recover on their time off. The obligation of physicians to provide after hour coverage and care is unavoidable and should be considered by an individual when they choose a career in medicine, and as a physician in managing their schedule/call.
A review of 100 studies from around the world indicates the culture of medicine contributes to doctors ignoring the warning signs of fatigue and stress and in many cases suffering from undiagnosed ailments such as stress and depression, or from burnout.59 The authors suggest the culture of medicine is such that doctors feel they don't need help; they put their patients first. Of the 18% of Canadian doctors who were identified as depressed, only a quarter of them considered getting help and only two per cent actually did. The report suggests that burnout from working long hours and sleep deprivation because of understaffing seems to be the biggest problem worldwide.60 The Canadian Medical Protective Association (CMPA) states that physicians should consider their level of fatigue and if they are clinically fit to provide treatment or care.61 Fatigue is not a sign of weakness. All members of the health care team should support their colleagues in recognizing and managing sleep deprivation and fatigue.
Physician fatigue has several ethical dimensions. The Canadian Medical Association Code of Ethics states that physicians have an ethical responsibility to self-manage their fatigue and well-being. 62 However, physicians must be trained and competent to know their own limits and evaluate their own fatigue level and well-being. The system must then support physicians in this recognition. The doctrine of informed consent is another dimension of physician fatigue. If physician fatigue is an added risk for any aspect of patient care, whether it is surgical or medical, elective or emergent, then some have argued that the doctrine of informed consent suggests that physicians have an obligation to inform patients of that risk.63 ,64 "The medico-legal considerations for physicians centre on the ethical duty to act in the best interests of their patients. This may mean that if a physician feels that his or her on-call schedule endangers or negatively impacts patient care, reasonable steps are taken to ensure patients do not suffer as a result and that the physician is able to continue providing an adequate level of care for patients."65
Addressing physician fatigue may have workforce implications.
Physician workload is multifaceted comprised of clinical, research, education and administrative activities. If physician workload or duty hours are reduced, any one of these activities may be impacted.
It has been suggested that implementing fatigue management strategies such as a workload ceiling for physicians may result in a greater need for physicians and thus increase system costs. However, new models of team based care delivery that incorporate technology, reduce redundancy, utilize a team based approach, and optimize the role of physicians offer an opportunity to better manage physician fatigue without necessarily requiring more physicians. Other strategies also need to be explored to improve the on-the-ground efficiency of physicians.
Some of the strategies to address practicing physician sleep deprivation/fatigue such as scheduling changes and reduced workload may affect access to care, including wait times. Surgeons or others may have to cancel surgeries or other procedures because of fatigue and hours of work, forcing rescheduling of surgery/procedures and potentially increasing wait times. This is particularly relevant given Canada's large geography and varied distribution of physicians. Therefore, flexibility in strategies to address physician sleep deprivation/fatigue are needed to reflect the variety of practice types and settings in existence across the country, in particular solo practices; rural, remote and isolated sites; community locations; etc. The same holds true for smaller specialties, which has been the experience in the UK with the implementation of the EWTD.
Fatigue management is a competency that needs to be taught, modelled, mentored, and evaluated across the medical education continuum, from medical student to practicing physician.
1. Educate physicians about the effects of sleep deprivation and fatigue on the practice of medicine and physician health, and how to recognize and manage their effects.
2. Create a national tool-box of self-awareness tools and fatigue management strategies and techniques.
3. Advocate for the integration of fatigue management into the continuum of medical education.
4. Advocate for the creation of system enablers with the flexibility to:
* Consider the full workload of physicians (clinical, teaching, administrative, research, etc.);
* Optimize scheduling to coordinate on call and other patient care following call; and
* Implement organizational/institutional level fatigue risk management plans.
5. Develop and advocate for implementation of standardized handover tools.
6. Enhance and reaffirm a culture within medicine that focuses on patient-centered care.
7. Reaffirm the culture shift within medicine that encompasses physician well-being.
8. Encourage physicians treating physicians to be aware of the aggravating effects of fatigue on their well-being and practice.
Physicians are interested in how to best meet the needs of the population, in continually improving the care provided to Canadians. To do so requires that they also care for themselves including managing the effects of sleep deprivation and fatigue. It is a complex issue that requires multifaceted solutions. Strategies must address physician fatigue at an individual, organizational/institutional and system level.
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