American Thoracic Society Documents

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1 American Thoracic Society Documents An Official American Thoracic Society Clinical Practice Guieline: Sleep Apnea, Sleepiness, an Driving Risk in Noncommercial Drivers An Upate of a 1994 Statement Kingman P. Strohl, Daniel B. Brown, Nancy Collop, Charles George, Ronal Grunstein, Fang Han, Lawrence Kline, Atul Malhotra, Alan Pack, Barbara Phillips, Daniel Roenstein, Richar Schwab, Terri Weaver, an Kevin Wilson; on behalf of the ATS A Hoc Committee on Sleep Apnea, Sleepiness, an Driving Risk in Noncommercial Drivers THIS OFFICIAL CLINICAL PRACTICE GUIDELINE OF THE AMERICAN THORACIC SOCIETY (ATS) WAS APPROVED BY THE ATS BOARD OF DIRECTORS, DECEMBER 2012 CONTENTS Executive Summary Conclusions Recommenations Introuction Methos Guieline Panel Scope, Questions, an Outcomes Literature Search an Recommenations Questions, Evience, an Recommenations Final Comments Backgroun: Sleepiness may account for up to 20% of crashes on monotonous roas, especially highways. Obstructive sleep apnea (OSA) is the most common meical isorer that causes excessive aytime sleepiness, increasing the risk for rowsy riving two to three times. The purpose of these guielines is to upate the 1994 American Thoracic Society Statement that escribe the relationships among sleepiness, sleep apnea, an riving risk. Methos: A multiisciplinary panel was convene to evelop evience-base clinical practice guielines for the management of sleepy riving ue to OSA. Pragmatic systematic reviews were performe, an the Graing of Recommenations, Assessment, Development, an Evaluation approach was use to formulate an grae the recommenations. Critical outcomes inclue crash-relate mortality an real crashes, whereas important outcomes inclue near-miss crashes an riving performance. Results: A strong recommenation was mae for treatment of confirme OSA with continuous positive airway pressure to reuce riving risk, rather than no treatment, which was supporte by moerate-quality evience. Weak recommenations were mae for expeitious iagnostic evaluation an initiation of treatment an against the use of stimulant meications or empiric continuous positive airway pressure to reuce riving risk. The weak recommenations were supporte by very low quality evience. Aitional suggestions inclue routinely etermining the riving risk, inquiring about aitional causes of sleepiness, eucating patients The prior official statement of the American Thoracic Society was aopte by the ATS Boar of Directors, June Sleep apnea, sleepiness, an riving risk. Am J Respir Crit Care Me 1994;150: /ajrccm This ocument has an online supplement, which is accessible from this issue s table of contents at Am J Respir Crit Care Me Vol 187, Iss. 11, pp , Jun 1, 2013 Copyright ª 2013 by the American Thoracic Society DOI: /rccm ST Internet aress: about the risks of excessive sleepiness, an encouraging clinicians to become familiar with relevant laws. Discussion: The recommenations presente in this guieline are base on the current evience, an will require an upate as new evience an/or technologies becomes available. EECUTIVE SUMMARY Obstructive sleep apnea (OSA) is the most common meical isorer that causes excessive aytime sleepiness; it is a risk factor for both rowsy riving an car crashes ue to falling asleep. The purpose of these Guielines is to upate the 1994 American Thoracic Society Statement that escribe the relationships among sleepiness, riving risk, an sleep-isorere breathing, the most common of which is OSA. The intene auience is the practitioner who encounters patients with sleep isorers. Conclusions OSA versus non-osa is associate with a two- to threetimes increase overall risk for motor vehicle crashes, but preiction of risk in an iniviual is imprecise. A high-risk river is efine as one who has moerate to severe aytime sleepiness an a recent unintene motor vehicle crash or a near-miss attributable to sleepiness, fatigue, or inattention. There is no compelling evience to restrict riving privileges in patients with sleep apnea if there has not been a motor vehicle crash or an equivalent event. Treatment of OSA improves performance on riving simulators an might reuce the risk of rowsy riving an rowsy riving crashes. Timely iagnostic evaluation an treatment an eucation of the patient an family are likely to ecrease the prevalence of sleepiness-relate crashes in patients with OSA who are high-risk rivers. Recommenations All patients being initially evaluate for suspecte or confirme OSA shoul be aske about aytime sleepiness, especially falling asleep unintentionally an inappropriately uring aily activities, as well as recent unintene motor vehicle crashes or near-misses attributable to sleepiness, fatigue, or inattention. Patients with these characteristics are eeme high-risk rivers an shoul be immeiately warne

2 1260 AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE VOL about the potential risk of riving until effective therapy is institute. Aitional information that shoul be elicite uring an initial visit for suspecte or confirme OSA inclues the clinical severity of the OSA an therapies that the patient has receive, incluing behavioral interventions. Aherence an response to therapy shoul be assesse at subsequent visits. The rowsy riving risk shoul be reassesse at subsequent visits if it was initially increase. For patients in whom there is a high clinical suspicion of OSA an who have been eeme high-risk rivers: B We suggest that polysomnography be performe an, if inicate, treatment initiate as soon as possible, rather than elaye until convenient (weak recommenation, very low quality evience). We recognize that the uration that constitutes as soon as possible will vary accoring to the resources available, but we favor the goal of less than 1 month. For appropriately selecte patients (e.g., no comorbiities, high clinical suspicion for OSA), at-home portable monitoring is a reasonable alternative to polysomnography. B We suggest NOT using empiric continuous positive airway pressure (CPAP) for the sole purpose of reucing riving risk (weak recommenation, very low quality evience). For patients with confirme OSA who have been eeme high-risk rivers, we recommen CPAP therapy to reuce riving risk, rather than no treatment (strong recommenation, moerate-quality evience). This suggestion is for CPAP because only its effects on riving performance have been well stuie; other treatments that coul accomplish the same goal have not been evaluate. For patients with suspecte or confirme OSA who have been eeme high-risk rivers, we suggest NOT using stimulant meications for the sole purpose of reucing riving risk (weak recommenation, very low quality evience). Opportunities to improve clinical practice inclue the following: B Clinicians shoul evelop a practice-base plan to inform patients an their families about rowsy riving an other risks of excessive sleepiness as well as behavioral methos that may reuce those risks. B Clinicians shoul routinely inquire in patients suspecte with OSA about non-osa causes of excessive aytime sleepiness (e.g., sleep restriction, alcohol, an seating meications), comorbi neurocognitive impairments (e.g., epression or neurological isorers), an iminishe physical skills. Such factors may aitively contribute to crash risk an affect the efficacy of sleep apnea treatment. B Clinicians shoul familiarize themselves with local an state statutes or regulations regaring the compulsory reporting of high-risk rivers with OSA. INTRODUCTION Automobile crashes are the fifth leaing cause of eath an injury in the Unite States (1). The number of crashes an severity of injury by istance riven are highest in young rivers (15 25 yr) an in those over the age of 65 years (2, 3). Fatality reuction currently targets increasing seat belt use an reucing speeing an alcohol (4, 5). However, inattentiveness, fatigue, an sleepiness are increasingly recognize as contributing, an possibly primary, factors (4, 6). Sleepiness accounts for 15 to 20% of crashes on monotonous roas, especially highways. Crashes ue to sleepiness typically involve running off the roa or into the back of another vehicle (6). Sleepiness is most commonly cause by insufficient sleep, which is associate with prolonge wakefulness or chronic sleep restriction ue to long hours of work or play (7, 8), shift work (comprising 7.4% of all those employe), or a variety of meical an neurological isorers (9 11). The most common meical isorer causing excessive aytime sleepiness is obstructive sleep apnea (OSA), a conition amenable to treatment (12 14). In 1994, the American Thoracic Society Assembly on Respiratory Neurobiology an Sleep reviewe the theoretical framework an evience relating to sleep apnea as a potential risk factor for motor vehicle crashes (15). Since then, the visibility of sleep isorers an riving risk has increase in the legal an meical literature (16). A 2003 survey of the American Thoracic Society (ATS) membership suggeste that approximately 30% of outpatient clinical practice is relate to sleep. Fellowship programs in pulmonary an critical care meicine incorporate training on sleep isorers (17, 18). A web-base ATS survey conucte from 2008 to 2009 inicate that approximately 90% of practitioners regularly assess patients with sleepiness an approximately 98% for rowsy riving in the past year. Seventy-five percent reporte that they use various methos to assess risk in patients, incluing the Epworth Sleepiness Scale (ESS), iscussion with family members, an irect questions on rowsy riving. Seventyseven percent state they were aware of state requirements for reporting of patients to the Department of Motor Vehicles, an 53% ha performe a meical assessment of a commercial river. Seventy-three percent reporte yes to the question, Are you familiar with the ATS 1994 statement on riving risk? In 2007, a reassessment of the 1994 statement was authorize by the ATS Boar of Directors with the following charges: (1) Provie practitioners with upate recommenations that escribe how one woul erive inferences about riving risks uring a clinical visit, (2) Rearess an upate the ethical (i.e., actions by the physician as a member of society) an legal (i.e., consequences of actions by a physician) ramifications that flow from these recommenations, an (3) Ientify action or research that is require in this area. The following is a summary of the recommenations from these eliberations. An online supplement provies a more nuance summary of group iscussions, as well as tables that summarize the evience supporting the recommenations. METHODS Guieline Panel The Sleep an Respiratory Neurobiology Assembly of the ATS evelope the project. Acting on recommenations from the proposers (Drs. Strohl an Schwab) after the collection an resolution of potential conflicts of interest, the panel was forme to represent broa interests, incluing the clinical management of sleep-isorere breathing (n ¼ 6), riving risk (n ¼ 2), behavioral sciences (n ¼ 1), an legal implications for patients an meical systems (n ¼ 1). In aition, the panel inclue international experience in meical issues of riving risk (n ¼ 4). No formal arrangements for cosponsorship were arrange with other professional societies; however, committee members use contacts to isseminate questions an collect feeback. A methoologist (Dr. Wilson) assiste in applying guieline methoology, incluing pragmatic systematic reviews of the literature an the formulation an graing of recommenations

3 American Thoracic Society Documents 1261 using the Graing of Recommenations, Assessment, Development, an Evaluation (GRADE) approach. TABLE 1. METHODS CHECKLIST Yes No Scope, Questions, an Outcomes Committee meetings were convene in 2008 an 2009 to ientify the scope an framework of the guielines. It was ecie that the emphasis woul be on noncommercial rivers, because this is the largest group of iniviuals likely to be seen by pulmonary specialists an others practicing sleep meicine (commercial licensing vehicle operators are regulate by specific meical requirements an assesse by certifie meical examiners, processes that are now unergoing revision). A secon ecision was to focus on the evience regaring physician ecision-making, testing, an ieal behavior accoring to best meical practice. During these initial eliberations, important clinical questions were pose with the intention of answering the questions with recommenations. Relevant clinical outcomes were also ientifie an prioritize; they inclue crash-relate mortality an actual crashes as critical outcomes an near-miss crashes an riving performance as important outcomes. Panel assembly Inclue experts for relevant clinical an nonclinical isciplines Inclue iniviual who represents the views of patients an society at large Inclue a methoologist with appropriate expertise (ocumente expertise in conucting systematic reviews to ientify the evience base an the evelopment of evience-base recommenations) Literature review Performe in collaboration with librarian Searche multiple electronic atabases Reviewe reference lists of retrieve articles Evience synthesis Applie prespecifie inclusion an exclusion criteria Evaluate inclue stuies for sources of bias Explicitly summarize benefits an harms Use PRISMA1 to report systematic review Use GRADE to escribe quality of evience Generation of recommenations Use GRADE to rate the strength of recommenations Literature Search an Recommenations A methos checklist is provie in Table 1. Some of the questions involve interventions for which there are no reasonable alternatives; recommenations answering such questions are consiere best-practice recommenations (i.e., motherhoo statements ), which o not require a systematic review of the literature or the GRADE approach. In such cases, a comprehensive but nonsystematic literature review was conucte. Key wors for the literature search inclue riving risk, sleep apnea, motor vehicle/automobile accients/crashes, legal issues, an physician liability. Subsearches were performe to assess the nonsleep literature. The following sources were searche: Meline ( an a secon for ); meical an law library searches (up to 2009); reviews of the bibliographic an abstract sections for the annual meetings of the American Thoracic Society an the Association of Professional Sleep Societies; an reference lists of selecte papers, eitorials, an chapters. We limite the review to peer-reviewe articles, reviews, an metaanalyses. Given the moral an ethical imensions of the topic, eitorials an book chapters were also inclue if the primary ata, conclusions, an/or positions were provie in etail. When possible, the group use recent evience-base reviews. Access was obtaine for sponsore surveys of the meical literature on riving risk for the National Transportation an Safety Boar Meical Boar, some of which are now publishe (19). As note in 1994, opinion an some stuies are available regaring riving risk for iniviuals with acute an chronic illnesses other than sleep apnea. A search of the 2007 to 2010 literature on riving risk assessments in aging, psychiatric illness, epilepsy, cariovascular isease, iabetes, Alzheimer s isease, hypertension, neuroegenerative isease, stroke, neurocognition, an rehabilitation meicine was performe an reference to the egree applicable to riving risks in chronic isease. Four questions require the selection of one course of action from among several reasonable options or approaches. Each was answere by a recommenation that was supporte by a pragmatic systematic review of the literature an both formulate an grae using the GRADE approach. We formulate a search strategy, an then one committee member (Dr. Wilson) searche Meline an the Cochrane Library (i.e., Cochrane Registry of Controlle Trials an Cochrane Database of Systematic Reviews) using these criteria (see Table E1 in the online supplement). Stuies were selecte accoring Definition of abbreviation: GRADE ¼ Graing of Recommenations, Assessment, Development, an Evaluation; PRISMA1 ¼ Preferre Reporting Items for Systematic Reviews an Meta-Analyses, version 1. to prespecifie selection criteria (Figures E1 E4). Aitional stuies were ientifie by reviewing bibliographies of selecte stuies an the personal files of the committee members. Once the pertinent evience was ientifie an appraise, the quality of evience was rate as high, moerate, low, or very low using the GRADE approach. The quality of evience inicates the committee s confience in the irection an magnitue of the estimate effects of each course of action. Recommenations were evelope from the evience. The strength of each recommenation was rate as strong or weak (19). A strong recommenation inicates that the committee is certain that the esirable consequences of the recommene course of action (i.e., the benefits) outweigh the potential unesirable consequences (i.e, risks, burens, costs, resource use) in the vast majority of patients. In contrast, a weak recommenation inicates that the committee is uncertain about the balance of esirable an unesirable consequences, or that the TABLE 2. OPPORTUNITIES FOR GREATER INQUIRY AND RESEARCH The high-risk river with sleep apnea How often o multiple risk factors for riving crash occur in patients with sleep apnea? How feasible are these ATS recommenations across ifferent pathways an platforms in the recognition an treatment of sleep apnea? What is the magnitue of expecte benefit of treating OSA relative to other riving risks? Professional training an practice How can competency of pulmonary practitioners in the assessment an prevention of rowsy riving be assesse? Eucation on health effects of sleep How can public perception of, an attitues about, the assessment for rowsy riving risk be aresse, not only in regar to personal health but also in regar to the right to rive? What eucational tools are effective in reucing rowsy riving in populations of patients as well as for the public at large? Challenges for licensing agencies What performance-base testing is appropriate for those treate with problem sleepiness? Definition of abbreviations: ATS ¼ American Thoracic Society; OSA ¼ obstructive sleep apnea.

4 1262 AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE VOL esirable consequences an potential unesirable consequences are finely balance. In this case, the recommene course of action is correct for most patients but may be incorrect for a substantial minority of patients. Final recommenations were erive by consensus; voting was not necessary. Deliberations an recommenations were compile into a ocument reviewe by the committee members in May 2010 an then sent by panel members to outsie reviewers from July through August The ocument was referre for a final review to the ATS section on Sleep an Respiratory Neurobiology in October After revisions to conform to the ATS format an GRADE approaches, the guielines were submitte to the ATS for external review in June Suggeste revisions an commentary from the external reviewers were compile an sent back to the committee in December 2011 an April QUESTIONS, EVIDENCE, AND RECOMMENDATIONS The statements summarize here are base on the prior ocument (15) an more recent eliberations an literature surveys. The online supplement iscusses some of the topics in greater etail. Question 1: Shoul riving risk be part of the initial assessment of patients who have suspecte or confirme OSA? Evience. Our literature search i not ientify any stuies that compare the effects of performing a riving risk assessment with the effects of not performing a riving risk assessment; thus, clinical experience was use to aress the question. The Committee consiers patients with OSA to be high-risk rivers if there is moerate to severe sleepiness (i.e., falling asleep unintentionally an inappropriately uring aily activities) plus a previous motor vehicle crash (in the remainer of this report, the phrase previous motor vehicle crash inclues near-miss events associate with river behavior that raises clinical alarm to an equivalent level). In the opinion of the Committee, recent times is an appropriate time span, rather than lifetime exposure (12). Both sleepiness an motor vehicle crashes are ientifie from the history provie by the patient or an informe observer. Although it is avocate that family members or others provie aitional insight about sleep an sleepiness at the time of the initial evaluation, it is not require that the physician wait until such information is available to make an assessment about the egree of sleepiness an its risks. Obtaining an official riving recor is not practical, because it is unlikely to arrive in a timely manner, given the nee for a signe release of information form an other proceural inertia. The clinician must irectly question the patient to ientify highrisk rivers. The alternatives self-reporte sleepiness, familyinitiate reports of rowsy riving, an a high (i.e.,.17 out of 24) ESS score are insufficient to ientify high-risk rivers. Selfreporte sleepiness is subject to interpretation an bias, an the ESS can neither confirm nor exclue sleepiness (20). Such finings are, however, useful prompts for the clinician to initiate irect questioning. Use of a single simplifie question has been compare with the ESS an other objective tests an foun to have some internal valiity (21). The question, Please measure your sleepiness on a typical ay, was rate by patients from 0 (i.e., no sleepiness) to 10 (i.e., the highest amount of sleepiness possible). Scores less than or equal to 2 an greater than or equal to 9 reliably preicte normal an abnormal ESS scores, respectively. This might be a simpler screening tool, with follow-up questions in those with a sleepiness rating greater than or equal to 9. The combination of moerate to severe aytime sleepiness an a previous motor vehicle crash in a patient with OSA is so compelling that physicians are obligate to intervene. The physician shoul immeiately warn the patient of the potential risk of riving until effective therapy is institute. Many patients with OSA present with miler sleepiness an only a slightly increase riving risk, just as many people with other chronic meical conitions associate with increase riving risk present with only a slightly increase risk (11). It is appropriate to eucate those with lesser egrees of sleepiness about the hazars of sleepiness, but such patients o not warrant expeite management. Objective tests an measurements are also insufficient to ientify high-risk rivers. As an example, consier the boy mass inex. An elevate boy mass inex implies that there is an increase riving risk, accoring to many reports (22); however, this feature is common among iniviuals without OSA an, therefore, preicts motor vehicle crashes with poor specificity. Test results without clinical assessment are not accurate enough to make a ecision about the risk for rowsy riving. The efinition of a high-risk river is the same for patients whose initial assessment follows a sleep stuy. The apnea-hypopnea inex is not part of the etermination of riving risk, because using it puts the patient into ouble jeopary; if the patient was not eeme to be an increase risk before the sleep stuy, then he or she shoul not be at higher risk after the stuy if there is no intervening event or clinical change. Recommenation 1: All patients being initially evaluate for suspecte or confirme OSA shoul be aske about aytime sleepiness (i.e., falling asleep unintentionally an inappropriately uring aily activities) as well as recent unintene motor vehicle crashes or near-misses attributable to sleepiness, fatigue, or inattention. Patients with these characteristics are eeme high-risk rivers an shoul be immeiately warne about the potential risk of riving until effective therapy is institute. This recommenation is similar to the 1994 ATS statement (15) an is reaffirme. Question 2: In aition to the queries about sleepiness an riving events escribe above, are there clinical inquiries that shoul be routine when assessing riving risk in a patient who has suspecte or confirme OSA? Evience. Our literature search ientifie no stuies that compare the effects of various clinical inquiries with the effects of not making those inquiries, so clinical experience was use to answerthequestion.thecommitteebelievesthatassessmentofthe riving risk of a patient with OSA shoul inclue consieration of potential coexisting factors that may precipitate, perpetuate, or preispose patients to a higher riving risk (17, 23). Examples inclue other sleep problems or isorers (e.g., sleep restriction), meical comorbiities, substances (e.g., alcohol) an some meications (e.g., seatives), all of which probably escalate the riving risk by increasing sleepiness (24). Other conitions that may coexist with OSA an contribute to riving risk without causing sleepiness inclue neurocognitive impairments (e.g., epression, neurological isorers) an iminishe physical skills. Aressing such risks may reuce riving risk, even without treatment of the OSA. Recommenation 2: For all patients who have suspecte or confirme OSA, clinicians shoul routinely inquire about aitional causes of sleepiness (e.g., sleep restriction, alcohol, or seating meications), comorbi neurocognitive impairments (e.g., epression or neurologic isorers), an iminishe physical skills as part of the assessment of riving risk. Such factors may aitively contribute to crashes ue to falling asleep an affect the efficacy of sleep apnea treatment.

5 American Thoracic Society Documents 1263 Question 3: What information unrelate to riving risk assessment shoul be routinely elicite uring the initial evaluation of a patient who has suspecte or confirme OSA? An, what information shoul be obtaine uring routine follow-up? Evience. Our literature search ientifie no stuies that compare the effects of various clinical inquiries with the effects of not making those inquiries, so clinical experience was again use to answer the question. The precise role of the primary care practitioner in the assessment of OSA is still being establishe, in part because the egree to which sleepiness an OSA pose hazars to the health an safety of the country was not appreciate when our previous statement was written in 1994 (15). In the opinion of the Committee, it is unreasonable to hol primary care practitioners to a stanar for recognition of sleepiness an its consequences. In contrast, specialists who have meical training an skills in the recognition an management of OSA shoul be hel to a higher stanar. The clinical management of OSA has been inclue in American Boar of Internal Meicine Pulmonary Boar certification testing for the past 25 years, inicating that pulmonary specialists in particular are expecte to be aware of the presentations an complications of OSA, incluing excessive sleepiness (17). Common elements of the initial evaluation of a patient with OSA inclue assessment of the severity of the OSA in clinical terms; assessment of sleepiness an rowsy riving (escribe above); estimation of the time until iagnosis or the initiation of therapy; etermination of the types of therapy that the patient has alreay trie, incluing behavioral interventions; ocumentation of the plan or initiation of therapy; an ocumentation of aherence to positive airway pressure therapy or another therapy. Reassessment of riving risk after the initiation of any OSA therapy shoul be performe routinely in those eeme high-risk rivers before the initiation of therapy. Retrospection by the patient or family after treatment may suggest that the riving risk was higher before treatment than previously appreciate. This is an opportunity to reinforce to the patient the importance of aherence to therapy an to reiterate that treatment of sleep apnea may reuce the risk of rowsy riving relate crashes. Documentation of risk reassessment over time is pruent for patients initially eeme high-risk rivers. There are no reliable objective tests that inicate that treatment has reuce the riving risk to an acceptable or community baseline level, an test results without clinical assessment are not accurate enough to make a ecision about the risk for rowsy riving. Recommenation 3: Information that shoul be routinely elicite uring an initial visit for patients with suspecte or confirme OSA inclues the clinical severity of the OSA, riving risk, an therapies that the patient has receive, incluing behavioral interventions. At subsequent visits, aherence an response to therapy shoul be assesse, an the rowsy riving risk shoul be reassesse if it was initially increase. Question 4: Shoul information on rowsy riving be provie at the initial assessment of a patient who has suspecte or confirme OSA? Evience. Only rivers are responsible for safe operation of a motor vehicle. However, the public an family members of a patient with sleepiness an sleep apnea can play an important role in mitigating risk, even though most are largely uninforme about sleepiness an riving risk. Counseling about the risks of rowsy riving may ientify patients who have alreay reuce their riving exposure or who will voluntarily stop riving (25, 26). Aitional counseling may be appropriate, an alternatives to riving may nee to be explore for those who are unconvince or unwilling to acknowlege their increase crash risk. Although such eucational efforts may be most important for high-risk rivers, they are also appropriate for those with lesser egrees of sleepiness, even though such patients o not warrant expeite management. There is concern that institution of punitive measures for noncommercial rivers might result in a misinforme, fearful iniviual an family who believe that a octor s interview can compromise their ability to rive an automobile. Recommenation 4: For patients who have suspecte or confirme OSA, we suggest eucating patients an their families about rowsy riving an other risks of excessive sleepiness as well as behavioral methos that reuce those risks. Question 5: How soon shoul iagnostic testing occur an, if inicate, shoul treatment be initiate in patients with suspecte OSA who have been etermine to be high-risk rivers? Evience. We performe a pragmatic systematic review of the literature, which sought stuies that evaluate the effects of the uration until iagnostic evaluation an initiation of therapy on crash-relate mortality, real crash rate, near crash rate, or riving performance in patients with suspecte OSA (Table E1). Our search ientifie no stuies that met our prespecifie selection criteria (Figure E1). Despite the paucity of supporting evience, the Committee believes that the esirable effects of early iagnosis an treatment outweigh the unesirable consequences in most high-risk rivers with suspecte OSA. Desirable consequences inclue earlier prevention of motor vehicle crashes an, possibly, relate mortality. Unesirable consequences inclue inconvenience to both patients an staff relate to rearranging the sleep laboratory scheule to accommoate high-risk rivers. The Committee s impression is base on nonsystematic clinical observations, similar to our previous ocument (15). Nonsystematic observations provie very low confience in the estimate effects (i.e., very low quality of evience). The relate recommenation is weak because the very low quality of evience creates uncertainty about the balance of the esirable an unesirable consequences. Polysomnography is the most efinitive an, therefore, the preferre iagnostic test. However, for appropriately selecte patients (e.g., no comorbiities, high clinical suspicion for OSA), at-home portable monitoring is a reasonable alternative to polysomnography. Recommenation 5: For patients in whom there is a high clinical suspicion of OSA an who have been eeme high-risk rivers, we suggest that polysomnography be performe an, if inicate, treatment initiate as soon as possible, rather than elaye until convenient (weak recommenation, very low quality evience). We recognize that the uration that constitutes as soon as possible will vary accoring to the resources available, but we favor the goal of less than 1 month. For appropriately selecte patients (e.g., no comorbiities, high clinical suspicion for OSA), at-home portable monitoring is a reasonable alternative to polysomnography. Question 6: Is there any value in initiating empiric continuous positive airway pressure (CPAP) in high-risk rivers with suspecte OSA while awaiting the iagnostic evaluation? Evience. We performe another pragmatic systematic review of the literature to look for stuies that evaluate the effects of empiric CPAP on crash-relate mortality, real crash rate, near crash rate, or riving performance in patients with suspecte OSA (Table E1). Again, our search ientifie no stuies that met our prespecifie selection criteria (Figure E2).

6 1264 AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE VOL Despite the lack of supporting evience, the Committee believes that the unesirable effects of empiric CPAP outweigh the esirable effects in most high-risk rivers with suspecte OSA. Unesirable consequences inclue the buren, cost, possibility that some patients will be unnecessarily treate, an possibility that the empiric CPAP will affect the accuracy of the iagnostic test leaing to errors with long-term impact. Desirable consequences inclue the possibility of lowering the riving risk sooner. The Committee s impression is base on nonsystematic clinical observations. Nonsystematic clinical observations provie very low confience in the estimate effects (i.e., very low quality evience). The recommenation is weak because the very low quality of evience causes uncertainty about the balance of esirable an unesirable consequences. Recommenation 6: For patients in whom there is a high clinical suspicion of OSA an who have been eeme high-risk rivers, we suggest NOT using empiric CPAP for the sole purpose of reucing riving risk (weak recommenation, very low quality evience). Question 7: Shoul patients with confirme OSA who have been eeme high-risk rivers have their OSA treate for the purpose of reucing the riving risk? Evience. We performe a pragmatic systematic review of the literature, which sought stuies that evaluate the effect of treatment on crash-relate mortality, real crash rate, near crash rate, or riving performance in patients with confirme OSA (Table E1). Our search ientifie three systematic reviews that inclue stuies that met our prespecifie selection criteria (Figure E3) (22, 27, 28). There was consierable overlap among the stuies inclue, an the finings were similar. All of the systematic reviews evaluate CPAP therapy an not oral appliances or surgery. We chose the most recent systematic review to inform our jugments (27). This review inclue 15 before-versus-after stuies an observational stuies (1,293 patients) (27). Metaanalyses foun a marke reuction in the incience of real crashes (os ratio, 0.21; 95% confience interval [CI], ), near-misses (os ratio, 0.09; 95% CI, ), an crash-relate events in a riving simulator (stanar mean ifference [SMD], events; 95% CI, to events) after the initiation of OSA treatment. The committee s confience in the estimate effects was increase by the magnitue of effect, although this was partially offset by inconsistency of estimates across stuies (Table E2). Our pragmatic systematic review also ientifie two beforeversus-after trials that were publishe after the systematic reviews. These stuies coul not be poole with the previous metaanalyses because ifferent outcomes were measure an the crue ata were not reporte. However, it is exceeingly unlikely that these stuies woul have change the estimates of effect, because the stuies are small an their finings are consistent with the metaanalyses. Specifically, one stuy (n ¼ 11 patients with OSA) foun that CPAP was associate with ecrease steering eviation (29), an the other stuy (n ¼ 11 patients being treate for OSA) foun more riving-relate incients in a riving simulator after one-night cessation of CPAP (30). Taken together, these observational stuies with a large magnitue of effect provie moerate confience (i.e., moerate-quality evience) in the estimate effects of CPAP on riving risk. The relate recommenation for CPAP therapy is strong, because the Committee is certain that the esirable consequences of CPAP therapy (i.e., fewer real an near-miss crashes) substantially outweigh the unesirable consequences (i.e., cost, buren, minor sie effects). Recommenation 7: For patients with confirme OSA who have been eeme high-risk rivers, we recommen CPAP therapy to reuce riving risk, rather than no treatment (strong recommenation, moerate-quality evience). This suggestion is for CPAP because only its effects on riving performance have been well stuie; other treatments that coul accomplish the same goal have not been evaluate. Question 8: Can stimulant meications be use to reuce the riving risk among patients with suspecte or confirme OSA who have been eeme high-risk rivers? Evience. There is interest in using alerting meications to improve or restore vigilance in the presence of sleep apnea (31, 32). We performe a pragmatic systematic review of the literature, which sought stuies that evaluate the effect of alerting meications (e.g., moafinil, methylpheniate) on crash-relate mortality, real crash rate, near crash rate, or riving performance in patients with suspecte or confirme OSA (Table E1). Our search ientifie no relevant stuies (Figure E4) In light of this, we broaene our search an sought inirect evience. This revise search ientifie a trial in which 16 healthy iniviuals were sleep eprive by remaining awake overnight an then ranomly assigne in a crossover manner to receive moafinil or placebo, with riving performance then assesse in a riving simulator. The stuy foun that moafinil was associate with less lane eviation, but there was no effect on spee eviation, off-roa incients, or reaction time. However, moafinil was associate with improve subjective appraisals of riving performance, suggesting that moafinil therapy may lea to overconfience in one s riving abilities uring sleep eprivation (33). The committee s confience in these results is very low, espite its ranomize esign, because the stuy s small size creates imprecise estimates of effect, an there is inirectness of both the population an outcome. The relate recommenation against alerting meication is weak, because the very low quality of evience creates uncertainty about the balance of unesirable effects (i.e., cost, buren, sie effects, an false reassurance) an esirable effects (i.e., better riving performance). Recommenation 8: For patients with suspecte or confirme OSA who have been eeme high-risk rivers, we suggest NOT using a stimulant meication for the sole purpose of reucing riving risk (weak recommenation, very low quality evience). Question 9: Is there a legal stanar for assessment of sleepiness an sleep apnea for pulmonary specialists an for other health professionals with expertise in sleep apnea? Evience. Uner general principles of malpractice liability, physicians are obligate to ahere to the prevailing stanar of care (16, 34, 35). The pulmonary physician has the knowlege an skills to perform a history an physical examination, being aware that many conitions, incluing sleep apnea, confer high functional risk for rowsy riving an nee ientification as re flags. Steps to mitigate risk can be institute immeiately while awaiting iagnosis an treatment. Once sleep apnea is etecte, there nees to be a plan to explain the goal of therapy an to assess the patient s response, with a goal of reucing risk (22). In general, any physician owes a uty to the patient to take steps to reuce the foreseeable risk that the patient will harm him or herself, incluing the task of operating a motor vehicle (16). This obligation woul orinarily inclue escribing the risks of a meical impairment an warning the patient to take appropriate precautions. If a patient s isorer also poses a anger to other people, the physician has a uty to these potential victims to take appropriate precautions to reuce the risks of harm to them. This uty has long been establishe in connection with infectious iseases an has been extene in recent years to cases involving psychiatric patients who present a foreseeable risk of violence to others (16). Liability to thir parties has been establishe in connection with potential

7 American Thoracic Society Documents 1265 impairments in riving performance, such as those associate with the sie effects of meication (36). It shoul be note that there are countries, such as Belgium, where reporting is simply unlawful, so that physicians who o report patients face possible prosecution (37). Thus, a physician who assesses patients with sleepiness shoul conform to the prevailing stanar of care an legal requirements in managing a patient with severe sleepiness. To o otherwise makes the physician liable to any person injure as a result of the patient s impaire riving. To what egree the octor is obligate to monitor the patient s compliance with the prescribe warnings is less clear, especially in light of the legally acknowlege responsibility of the patient to ahere to the octor s instructions (38). There is the expectation of meeting prevailing legal requirements, which coul vary by state or country. In states with permissive reporting mechanisms, the Committee believes that, at a minimum, the physician shoul notify the Department of Motor Vehicles if a highest-risk patient (e.g., severe aytime sleepiness an a previous motor vehicle crash or near miss) insists on riving before the conition has been successfully treate or fails to comply with treatment requirements. Recommenation 9: Clinicians shoul familiarize themselves with the presentations an complications of excessive sleepiness as well as local an state statutes or regulations regaring the compulsory reporting of high-risk rivers with OSA. FINAL COMMENTS Physicians, patients, an regulatory/legal systems ieally woul have a mutual unerstaning of the importance of recognition of sleepiness as a risk factor for safe riving an encourage interventions to reuce risk involve in rowsy riving. Society is responsible for eciing threshols for tolerance an implementation of policy an regulations. Physicians are responsible for clinical management but are also citizens an opinion leaers. Patients are rivers, workers, family members, an voters. However, the elements in assessments an prevention form a social triangle. At any one time, the players can change roles as victim, savior, or persecutor. Communication as to the manner an purpose of assessments is essential, as is the physician s character as an avocate for the patient s rehabilitation an health in regar to the management of sleep apnea. Many interesting questions that might be useful for iscussion or research at a meical unergrauate or grauate level were ientifie uring the course of the iscussions (Table 2). These guielines were prepare by an a hoc Committee of the Assembly for Sleep an Respiratory Neurobiology. Members of the Committee are as follows: KINGMAN P. STROHL, M.D. (Chair) DANIEL B. BROWN, J.D. NANCY COLLOP, M.D. CHARLES GEORGE, M.D. RONALD GRUNSTEIN, M.D. FANG HAN, M.D. LAWRENCE KLINE, M.D. ATUL MALHOTRA, M.D. ALAN PACK, M.D., M.S. BARBARA PHILLIPS, M.D., M.P.H. DANIEL RODENSTEIN, M.D. RICHARD SCHWAB, M.D. TERRI WEAVER, R.N., Ph.D. KEVIN WILSON, M.D. Author Disclosures: K.P.S. was presient of ionsleep sleep meicine consultants; he serve as a consultant for Inspire Meical Systems ($10,000 49,999), serve on avisory committees for SleepMe ($5,000 9,999) an Sleep Solutions, Inc. ($5,000 9,999), an receive research support from Inspire Meical Systems ($10,000 49,999). D.B.B. was managing shareholer of Brown, Dresevic, Gustafson, Iwrey, Kalmowitz, an Penleton, Health Law Partners, LLC; he serve on the avisory boar of the Sleep Center Management Institute. N.C. serve on the boar of Johns Hopkins Pharmaquip (up to $1,000) an receive research support from Sepracor ($50,000 99,999). C.G. serve on the boar of Sleep Tech, LLC ($5,000 9,999). L.K. was presient of the Lash Founation ($50,000 99,999) an hel stock or options in Altria Group, Inc. ($50,000 99,999). A.M. serve as a consultant for Apnex ($10,000 49,999), ApniCure ($1,000 9,999), Galleon ($1,000 9,999), Philips Respironics ($10,001 49,999), Pfizer ($1,000 9,999), an SGS ($10,000 49,999). D.R. serve on avisory committees of Boehringer Ingelheim (up to $1,000) an GlaxoSmithKline (up to $1,000); he receive lecture fees from Boehringer Ingelheim (up to $1,000) an GlaxoSmithKline (up to $1,000), an research support from Astra ($10,000 49,999) an GlaxoSmithKline ($5,000 9,999). R.S. serve as a consultant for Apnex ($5,000 24,999) an ApniCure ($5,000 24,999). T.W. hel licensing agreements for FOSQ with Apnex, Cephalon, GlaxoSmithKline, Nova Norisk, Nova Som, an Philips Respironics; she receive royalties or license fees from Apnex ($5,000 24,999), Cephalon ($5,000 24,999), GlaxoSmithKline ($5,000 24,999), Nova Norisk ($5,000 24,999), Nova Som ($5,000 24,999), an Philips Respironics ($5,000 24,999); she receive research support from Cephalon ($5,000 24,999), Nova Som ($5,000 24,999), an Philips Respironics ($5,000 24,999). K.W. was employe by UpToDate, Inc., an the American Thoracic Society, an hel investment accounts with State Street Bank that were inepenently manage by Mooy, Lynn & Co. an may at times have inclue healthcare-relate holings. R.G., F.H., A.P., an B.P. reporte no relevant commercial interests. References 1. Miniño AM, Arias E, Kochanek KD, Sherry L, Murphy SL, Smith BL. Deaths: final ata for National Vital Statistics Reports; Vol. 50, No. 15. 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