Chapter 13

Public health and legal implications of OSA

G.B. Mwenge and D. Rodenstein

Summary
Patients with obstructive sleep apnoea (OSA) have increased utilisation of health resources. Costs are related to the severity of the disease and the associated comorbidities. Patients with OSA have been shown to have more motor accidents than drivers in the general population and more accidents at the workplace. The application of an efficient treatment in OSA results in a significant reduction in healthcare costs in the months and years that follow. In fact, several studies have shown that the treatment of OSA is cost-effective. Despite the fact that OSA is a serious risk factor for motor accidents, there is no harmonisation among European countries in the way in which legislation regarding driving licence is applied. OSA is not mentioned in Annex III of the European Directive, which legislates the driving licence. This chapter highlights many aspects of OSA that are usually beyond the scope of the medical practitioner. It provides a much more complete picture of the implications of a disease on the individual patient, as well as on the economy, the safety of transportation and driving and, finally, society as a whole. Keywords: Accidents, driving licence regulations, healthcare costs, obstructive sleep apnoea, workplace
Pneumology Dept and Center for Sleep Medicine, Cliniques universitaires Saint-Luc, Brussels, Belgium. Correspondence: D. Rodenstein, Cliniques universitaires Saint-Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium, Email daniel.rodenstein@ uclouvain.be

PUBLIC HEALTH AND LEGAL IMPLICATIONS OF OSA

Eur Respir Mon 2010. 50, 216224. Printed in UK all rights reserved. Copyright ERS 2010. European Respiratory Monograph; ISSN: 1025-448x. DOI: 10.1183/1025448x.00024909

bstructive sleep apnoea syndrome (OSA) was only identified 40 yrs ago, yet it appears as a very prevalent disease affecting the health of millions of people. OSA has been estimated to represent one of the most frequent chronic respiratory diseases, perhaps second after bronchial asthma [1], especially if considered that, in Canada, the 1998/1999 National Population Health Survey reported a prevalence of physician-diagnosed asthma of 8.4% in the overall population and that the estimated prevalence of sleep nocturnal breathing disorder, defined as an apnoea/ hypopnoea score of 15 events?h-1, was 4% in females and 9% in males [2]. As obesity is increasing worldwide, it can be expected that the prevalence of OSA will also increase [3]. Patients with OSA have increased utilisation of health resources. Several studies from different countries have shown that healthcare costs are higher in patients with OSA, and that the costs increase over time until diagnosis and decrease after administration of an effective treatment [4, 5].

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Costs are related to the severity of the disease, with more severe patients spending more than less affected patients [6]. Herein, we will review the economic and social aspects of sleep apnoea, the impact of the disease on professional performance, work and motor accidents, and some legal issues related to OSA.

Social aspects of OSA

OSA represents not only a medical but also a social problem. It may also represent a health hazard for unaffected individuals who happen to cross the road in front of these patients. In fact, OSA is characterised by some degree of daytime sleepiness. It is generally not an extreme somnolence as it can be seen in narcolepsy, yet it is consistently described in the upper limits of what is considered normal, or already in the boundaries of excessive sleepiness. This appears to have some effect on tasks requiring sustained attention, such as driving. Patients with OSA have been shown to have more motor vehicle accidents (MVA) than drivers in the general population. OSA represents a risk factor for MVA, which is estimated to be three to seven-fold of that of the general population [7]. Thus, the cost of MVAs may be seen as part of indirect health costs of OSA. With the same reasoning, treatment of OSA decreases, and even normalises, the rate of MVAs resulting in a reduction in the indirect economic costs due to the disease, or even in global economic savings for society [8]. In some countries, the increased risk of MVA has prompted a specific consideration of OSA in the framework of the legislation for driving licenses. For instance, questionnaires for driving license applicants may include questions on OSA symptoms; patients diagnosed but untreated may be considered unable to drive, or some restrictions may be applied to their driving whereas treated patients may recover full ability to drive. However, within the European Union there is still a lack of uniformity concerning driving license regulations. Drivers with undiagnosed OSA may freely drive within Europe, crossing borders with different rules. The basic legislation on driving and health is documented in Annex III of Directive 91/439/CEE, which was approved in 1991 and later amended. Annex III includes a list of diseases that should be taken into account at the time of administering a driving license. However, Annex III does not include OSA and the next amendment of the Directive, which will come into effect in 2013, remains silent about OSA, the disease which is probably the one carrying the greatest risk for MVAs [9]. The situation may be even more troublesome if one considers professional drivers, who are believed to have an increased prevalence of OSA [10]. An Australian report [11] found that in a sample of commercial truck drivers 15% had OSA (assessed with questionnaires and polysomnography), whereas a study from Brazil found a quarter of truck drivers to be at risk for OSA according to the Berlin questionnaire results [12]. A previous report from the USA found that 10% of long-haul truck drivers had .30 falls in oxygen per hour of sleep [13].

Economic aspects of OSA

It seems beyond doubt that OSA increases health expenditure during the silent phase of the disease, i.e. when OSA is already present but has not been diagnosed (this is also referred to as the pre-clinical phase of a disease). Several well-conducted studies have consistently shown that healthcare costs are increased by 50100% in patients who will be diagnosed with OSA in the following years with respect to the general population. This is true not only in middle-aged adults, but also in children [14] and in older males and females. These increased costs have been analysed in some studies, and may be attributable to cardiovascular diseases, digestive problems and metabolic diseases in adults, whereas in children the excess costs are mainly due to ear, nose and throat conditions and respiratory conditions [15, 16]. Once OSA has been diagnosed, a treatment may be proposed. The application of an efficient treatment in OSA results in a significant reduction in healthcare costs in the months and years

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that follow. These reductions narrow the difference between the costs of patients (which start to decrease) and those of the general population, which continue to increase with time, although at a much lesser rate. The treatment does not completely cancel out the difference, but attenuates it by approximately half the amount. Again, this appears to be true at all ages, from infancy to old age [15]. The fact that healthcare costs decrease with treatment does not necessarily mean that the treatment is cost-effective. The concept of cost-effectiveness is not straightforward, and may merit some explanations. It represents the ratio between the cost of a medical intervention and the consequent results. The cost is generally measured in monetary terms. The results are measured in terms of improvement in health; herein lays the problem. Who measures the improvement? In what unit is the improvement expressed? How does one standardise the concept of health so as to compare the improvements obtained with different treatments, or in different diseases? Indeed, the usefulness of the cost-effectiveness concept is to allow comparisons of the amount of health one buys with a given amount of money. The results, or outcomes, are generally measured in quality-adjusted life-years (QALYs). QALYs are the most common outcome measure in cost-utility analyses of healthcare programmes. It offers a straightforward procedure for combining the two most important outcomes of healthcare programmes, quality of life (improvement in the health status as perceived by the patient due to the medical intervention) and quantity of life (the duration of this improvement), into one single measurement. QALYs indicate the impact of a medical intervention on the number of years in full health when full health is defined by the patient.
PUBLIC HEALTH AND LEGAL IMPLICATIONS OF OSA

Each disease, and within each disease its degree of severity, will lead to a certain decrease in the health-related quality of life. A treatment will then allow for a (full or partial) recovery of quality of life. Patients will then standardise this change by comparing it to a theoretical state of full health. In this way, patients will judge whether the medical intervention has resulted in a recovery of, for instance, 50% of a year in full health or 5% of a year in full health. If the duration of the improvement is known, or can be estimated, then one can calculate the total value of a medical intervention, or in other words the degree of improvement in standardised health-related quality of life for a given duration. Thus, the denominator of the cost-effectiveness ratio is obtained. If one knows the monetary cost of the medical intervention, one can calculate the cost per year in theoretical full health or cost per QALY. With this measurement it is possible to determine, for example, that 2 yrs in a hospital bed or wheelchair will essentially be worth ,2 yrs in perfect health for the same individuals. Once QALY is determined for each of the different treatments being compared, one must determine the costefficiency. This ratio is simply the cost divided by the output expressed in QALYs. For example, if the cost of treatment A is $10,000 and that of treatment B is $20,000 and the results in terms of QALY is 2 yrs for treatment A and 5 yrs for treatment B, this means that treatment A gives health results that the patient estimates similar to 2 yrs in full health, whereas treatment B results in something similar to 5 yrs in full health. Therefore, the cost-utility ratio is $5,000 per year of life in full health for treatment A and $4,000 per year of life in full health for treatment B. Thus, despite a higher price for treatment B, the latter is more beneficial to society since it has a better cost-efficiency ratio. The advantage of this complex concept is that one can compare the QALYs bought per Euro in different diseases or in a given disease by different treatments. This can help the decision to allocate resources in a more efficient way, by spending money in health sectors where the gain in QALYs will be maximal. Or in deciding to stop the reimbursement of a medical intervention because a different one will cost less and result in the same QALYs, or cost the same but obtain more QALYs.

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It is generally assumed that when the cost-effectiveness ratio of a medical intervention is below a given threshold, the intervention is worth paying for. In international terms, the threshold is assumed to lie between two and three times the per capita gross domestic product. This is approximately J30,000 per QALY in Europe [17]. The treatment of OSA has been assessed within this framework. A recent study from the UK has evaluated the cost-effectiveness of the treatment of OSA with continuous positive airway pressure (CPAP) [18]. The authors included the direct medical costs (among them the costs of diagnosing and treating the disease), the preventive effect of treatment on cardiovascular and cerebrovascular accidents and the costs related to MVAs. They calculated that treating OSA is cost-effective provided the treatment lasts for at least 2 yrs. The cost-effectiveness will improve thereafter as the cost remains stable (the diagnostic process does not need to be repeated; the CPAP machine has already been bought) but the benefits increase year after year. Considering the costs that would have been incurred if the treatment had not been started, for instance a myocardial infarction, the authors calculated that the treatment of OSA was not only cost-effective but it was even costsaving after 13 yrs of treatment. This means that if treatment lasts for 13 yrs, the entire health costs incurred by the patient will be less than the cost of their treatment for OSA during those 13 yrs. Thus, society would save money [18]. In other words, they estimated that at yr 1 the cost per QALY for CPAP compared to no CPAP is expected to exceed 20,000, after 2 yrs the expected cost per QALY gained is f10,000, and after 11 yrs CPAP is the dominant treatment. For instance, the cost per QALY gained compared to with no treatment after 14 yrs is 1,620 (95% CI 4,123259). Other reports from Canada and Spain have also found this treatment to be cost-effective [1921]. In Canada, AYAS et al. [20] performed a cost-utility analysis comparing CPAP with a do nothing alternative for the treatment of patients with moderate-to-severe obstructive sleep apnoea/ hypopnoea syndrome (OSAHS). In this study, the authors took into account CPAP compliance; a compliance rate of 70% was assumed. In Spain, MAR et al. [19] performed a cost-utility analysis comparing CPAP with a do nothing alternative for the treatment of patients with OSAHS and concluded that CPAP is cost-effective. All studies are summarised in table 1. These values compare very favourably with other publicly funded therapies, such as primary prevention of cardiovascular events using cholesterol-lowering therapy, which is .US$54,000 per QALY) [22].

OSA and professional performance

OSA leads to a certain degree of excessive daytime sleepiness. This can also be viewed as a decrease in the degree of alertness, which could have an impact on professional activities. Some reports lend support to this hypothesis. ULFBERG at al. [23] found that patients with OSA (but also snorers) had
Table 1. Cost-effectiveness studies for continuous positive airway pressure treatment First author [Ref.] G UEST [18] Cost effectiveness $ per QALY AHI of case study events?h-1 ESS Country GBP 1400 .30; severe 12 UK A YAS [20] US$ 3354 .15; moderateto-severe Canada M AR [19] J7861 41.314.6 13.85.8 Spain T OUSIGNANT [21] US$ .9792 Moderate and severe; 67.624.3 Canada

All studies compared continuous positive airway pressure treatment to a do nothing alternative. QALY: quality-adjusted life-year; AHI: apnoea/hypopnoea index; ESS: Epworth Sleepiness Scale.

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more daytime sleepiness at work, and had worst results than subjects without OSA or snoring in questionnaires concerning learning new tasks, concentration and performing monotonous tasks. MULGREW et al. [24] studied patients with sleep-disordered breathing sent for polysomnography. They found work limitations (assessed with a multidimensional occupational questionnaire) to be significantly more present in the more sleepy patients compared to the less sleepy patients. This was independent from the severity of OSA itself, and seemed to depend solely on the daytime sleepiness. It should be mentioned that the sleepier group was indeed extremely sleepy, much more so than is usually observed in OSA patients. One may ask whether these data represent the effects of sleepiness or are secondary to a more pervasive effect of OSA on cognitive performances in general, where attention deficits and sleepiness are one manifestation. Cognitive performances have been shown to be affected in patients with OSA [25]. FINDLEY ET AL. [26] have studied cognitive impairment in patients who had sleep apnoea with hypoxaemia and without hypoxaemia. They concluded that hypoxaemic patients with sleep apnoea had mean performance scores in the impaired range on measures of attention, concentration, complex problem-solving and short-term recall of verbal and spatial information. In contrast, patients who had sleep apnoea without hypoxaemia had no mean performance score in the impaired range. In this study the authors underlined the importance of hypoxaemia. ENGLEMAN et al. [27] also studied the cognitive performance in sleep apnoeahypersomnolence syndrome (SAHS). The authors suggested that deficits broadly worsen with disease severity, with large average values for attention and executive functions. They concluded that sleepiness, as well as hypoxaemia, might contribute to cognitive deficit. Finally, through a meta-analysis of randomised, placebo-controlled, crossover studies of CPAP treatment involving 98 SAHS patients (apnoea/hypopnoea index (AHI) o5 or presence of two symptoms) they showed a trends towards better cognitive performance on CPAP than on placebo, although the enhancements on CPAP were small.

PUBLIC HEALTH AND LEGAL IMPLICATIONS OF OSA

OSA and accidents at work

Accidents in the workplace represent a significant economic burden for employers, and a significant health risk for employees. OSA may represent a causal factor in work accidents. LINDBERG et al. [28] showed that subjects with snoring and daytime sleepiness had an increased risk for occupational accidents (retrieved from a national database) during a 10-yr follow-up, with an adjusted odds ratio of 2.2 (95% CI 1.33.8). This increased risk took into account differences in age, body mass index, smoking, alcohol dependence, years at work, blue-collar job, shift work and exposure to noise, organic solvents, exhaust fumes and whole-body vibrations. Neither snoring alone nor daytime sleepiness alone were associated with an increased occupational risk. KRIEGER et al. [29] have shown that in the 12 months after initiation of treatment with CPAP, both occupational and domestic accidents and near-miss accidents decreased, as did decrease the number of patients declaring an accident or a near-miss accident.

OSA and MVAs

This is one of the most thoroughly studied aspects of the disease. The first reports of an increased number of MVAs in patients with sleep apnoea were published in the late 1980s [30, 31]. Many studies have been published since then using different methodologies, from epidemiological studies to cohort studies, casecontrol studies and follow-up studies. Several investigators relied on patients responses (subjective data), whereas many others turned to official databases of MVAs (in general more serious accidents involving personal injuries or significant financial consequences). Several studies have reported on the effects of treatment (usually with CPAP)

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on MVAs, comparing, in a cohort of patients, the rate of MVAs for a given time before and after the initiation of therapy. Patients were frequently compared with a control sample, either limited in number and matched to the patient group on several aspects or including all the population in a given geographical area (an island or a state). In most studies many factors that could influence the comparisons were accounted for in the calculations. These include, for instance, distance driven per year, visual troubles, medications and alcohol consumption, body mass index, smoking, work schedule and comorbidities. Most studies have tried to assess the possible relationships between the severity of the disease, either through the AHI or the desaturation index, or the severity of the disease-related sleepiness, usually assessed with the Epworth Sleepiness Scale or some index of sleep fragmentation, such as the movement arousal index or the rate of MVAs. Results are concordant; there is an increased risk for MVAs in patients with OSA, either for MVAs in general or for serious MVAs only. This excess is negated when patients start and remain on treatment with CPAP. The average increase in risk across all studies is in the range of three-fold with respect to the general population. A meta-analysis was performed comparing the risks for MVAS in all medical conditions reported in the literature [7]. The summary of this meta-analysis was that most medical conditions confer an increased risk between 1.2- and 2-fold with respect to a healthy population (meaning that the disease increases the MVA rate by 20100%). OSA had the highest increased risk, with a relative risk of 3.71, which is second only to age and sex as a general risk factor for MVAs. A recent survey among Spanish commercial drivers [32] unveiled a series of specific attitudes related to excessive sleepiness at the wheel that are not usually considered in the medical context. These attitudes may serve as alerting signals that the sleepiness level is too high, and that stopping driving may be the best strategy in order to avoid an impending MVA. The survey was based on group interviews with professional drivers, centred on the main problems they found in their professional life. Sleepiness emerged as one of the most pervasive problems among a majority of interviewed drivers, including specific symptoms related to driving tasks, as well as spontaneously found countermeasures [32]. A list of these attitudes is given in table 2. The economic impact of MVAs related to OSA has been assessed in a theoretical study by SASSANI et al. [8]. Based on all published available evidence, the authors calculated the total costs of MVAs attributable to OSA in the USA. They then estimated the total cost due to these accidents (medical and nonmedical, including lost work days, vehicles repairs, etc.). This resulted in a total cost of US$15,900,000,000. The authors estimated then the cost of diagnosing and treating all patients in the country and the impact of this policy on MVAs. They used very conservative estimates (e.g. a 20% diagnostic yield and a 70% therapy success rate), yet they concluded that the net result would be a very significant saving of US$7,900,000,000.

Legal aspects
This section will mainly deal with the situation prevailing in the European Union, and will be specifically related to the driving license regulations. As already stated, Directive 91/439/CEE published on July 29, 1991 is the legal basis for the common rules for driving licenses in the European Union. It includes Annex III which deals with all medical aspects, i.e. specific diseases that may impair driving abilities and that require a specific assessment to evaluate whether it is safe to allow the candidate to drive or whether remedial measures are needed (e.g. to wear glasses to correct a visual defect, to stop driving for a specified period after a heart attack, etc.), or whether the driver should be declared unable (unsafe) to drive. Beyond abiding by Directive 91/439/CEE, individual countries are free to initiate more stringent rules. When it became evident that OSA was a serious risk factor for MVAs some medical experts started national lobbying actions and some succeeded in modifying their national driving license regulations. However, this is far from being generalised. Moreover, the European Union has

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Table 2. Warning signs of drowsy driving in commercial drivers Alerting signals Presence or flashes of false images, such as seeing a light, believing that another vehicle is in front or seeing a building, trees or animals Excessive blinking, or blurred vision, rubbing eyes frequently, inability to concentrate, difficulty in keeping eyes open, frequent change in position Yawning repeatedly or having trouble keeping head up Lack of concentration, incoherent thoughts, dreams Focused attention on the road, not paying attention to traffic signals or ignoring a red traffic light due to not paying attention Needing to manage one thing at a time, difficulties estimating the distance of another vehicle Feeling of not remembering the distance travelled or having passed a locality without remembering Taking a turning, changing direction or route, or making an unplanned stop, e.g. the petrol station, in an automatic way Changing lanes without reason, being too close to the vehicle in front, accelerating for no reason, lack of sensation of increased speed on a downward slope
PUBLIC HEALTH AND LEGAL IMPLICATIONS OF OSA
Modified from [32] with permission from the publisher.

Counter measures Increased consumption of cigarettes at times of fatigue or overwork Increased consumption of confectionary, chewing gum or sweets to offset fatigue Resorting to cooling the face Reducing the temperature inside the vehicle Needing to increase volume of music or to make it more lively

extended its geographical boundaries far beyond what they were in 1991. Therefore, the present situation resembles more of a chaos plan than to a rational plan. A survey published in 2008 concerning 25 European countries showed that OSA was mentioned in Annex III of the national rules in 10 countries, whereas it was not mentioned at all in the national rules of the other 15 countries [33, 34]. Since free movement is a cardinal rule within the European Union, drivers from countries where untreated OSA does not constitute a limitation to drive can drive freely in countries where there are restrictions for drivers with untreated OSA. This applies both to private drivers and commercial drivers. It appears wise to continue lobbying actions to include the disease representing the most serious risk for MVAs in Annex III of the European Directive [35]. All the more so that this is a treatable disease, and that it has been shown time and again that compliant patients treated with CPAP normalise their MVA increased risk [29].

Conclusions
This chapter highlights many aspects of OSA that are usually beyond the scope of the medical practitioner. It allows a much more complete picture of the implications of the disease on the individual patient, as well as on the economy, the safety of transportation and driving and, finally, society as a whole. We conclude that OSA represents a serious handicap in enjoying life for patients, but it represents also a serious economic burden for the patient, their employers, the insurance industry and the social healthcare system. In addition, it represents a serious safety hazard for drivers, their

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passengers and innocent bystanders. Very few examples exist of a disease that costs so much and for which treatment can save not only health, but also lives and money.

Statement of Interest
None declared.

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