Eli O. Meltzer, MD

Authors of papers presented in this Supplement met in person at the 2011 Annual Meeting of the American College of Allergy, Asthma & Immunology to further discuss the clinical, social, and economic implications of the findings from the Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC. This paper represents an edited transcript of their discussion.

Given the recent changes in US health care, how should the results of the NASAL 2010 survey be used to inform current practice? What about the role of other health care professionals and what are the cost implications of the survey findings?

Dr. Hadley: Firstly, it is important to note that there were improvements in the design of the NASAL 2010 survey compared to its 2006 predecessor. More importantly, although some of the 2010 information was a little bit different, we found that the majority of patients still suffer from their symptoms, and that the symptoms are predominant and bothersome. Allergic rhinitis bothers their sleep; it bothers their work and daily activities. In other words, we have not really seen any difference in achieving a reduction of the patients’ symptoms from 2006 to 2010.

Dr. Meltzer: Looking at this issue more globally, I think that the lack of change has a great deal to do with the public not understanding what “health” is. The World Health Organization (WHO) definition of health is there should be no problems with physical, social, emotional, or mental well-being. Individuals often do not appreciate how healthy they could be, and thus do not have a reference point. The NASAL survey clearly shows that most nasal allergy sufferers are not aware of an appropriate respiratory health goal and, further, they are not cognizant of the magnitude of their disease due to their allergic rhinitis. I believe the patients are not the only ones who are unaware; I think many clinicians are also not aware of the extent of their patients’ morbidity. A current problem is that there is not enough assumption of responsibility; patients are not taking enough responsibility for their health, clinicians are not adequately managing these patients, and—despite the suggested health care reforms—there does not appear to be in the foreseeable future a system that is going to alter these conditions.

Dr. Stoloff: For example, many family physicians only ask the question “How are you (with respect to this topic)?” and patients often say they are fine, and that’s the end of the dialogue. But consequences of this type of discussion are that costs of health care continue due to the lack of health. So the person misses work or the person’s job performance is less than it would be because they don’t recognize what their health could be if they were properly treated. As far as they’re concerned, this situation has been going on year after year, and it is only when they are really bad that they know they should be somewhat better. Even then, most people do not fully appreciate what is achievable because no one in the health care system has ever told them, “You should be able to sleep through the night and wake up feeling well. You should be able to go to work. You should be able to participate in athletic, recreational venues to be healthy.” No one has brought that up, and as long as this situation continues, the cost for the patient, his or her family, and health care will continue to increase.

Dr. Hadley: One of the things that I see as an otolaryngologist is that there is also often a missed diagnosis. Everybody who comes in to see me tells me: “Doctor, I have ‘sinus’.” I think most of them are simply unaware of that fact that their nasal congestion plays a role in developing their sinus symptoms. So there is general unawareness of the importance of treating nasal allergies in the lay public, as well as in primary care physicians who have to deal with these patients. Going to issues of cost, I think that patients are seeing the economy go down, and this means that they don’t want to spend a lot of money on their health care. They have a lot of other worries, and I think this is playing a role in how we have to deal with our patients.

Dr. Stoloff: People need to understand that the cost of not spending money to be healthy has a consequence that is sometimes the greater cost of being unhealthy—cost in terms of morbidity, cost in terms of missed days from work, absenteeism, presenteeism, poor ability to function in the usual domains of physical, social, emotional, and mental.

Dr. Hadley: That’s what the public just does not understand. We have not achieved the goal of informing the lay public and practitioners about how effective management can get these patients better, reduce their costs, and enable patients to go back to work and their activities.

What should be done to better act on the challenges highlighted by these important surveys? Is there a need to increase the awareness of allergic rhinitis among health care providers?

Dr. Meltzer: If we’re not making progress then we have to make some changes. It seems to me that education could drive change. The public needs to better understand that it is not insignificant to have an inflammatory process called allergic rhinitis. Allergic rhinitis is clearly underestimated in terms of its burden. It is too often unrecognized or ignored as an inconsequential problem. It is important that the person who has allergic rhinitis does not disregard the burden of disease. The NASAL survey reports that allergic rhinitis affects the ability to sleep well in 40 of patients. We know that allergic rhinitis also compromises people’s activities and we know that they are not as productive when they’re at work. We also know there are many comorbidities—asthma in particular, and sinusitis, otitis, conjunctivitis are other common associated conditions. Patients and clinicians need to be educated to appreciate the significant morbidity associated with allergic rhinitis, and that nasal allergies need attention and effective control.

Dr. Hadley: One of the things that we all see is patients not always getting important information about the medications that they take; there is a walk-in to the grocery store and the pharmacy shelves are filled with medications that are over-the-counter. The problem is there is not enough education about what the benefits are and what the side effects are of all those medications. There is also a lot of direct to consumer advertising—radio, television, etc., that also leads to misconceptions about the benefits of some of these medications. Patients are somewhat aware that they have a problem, but they just don’t know where to go. From the health care provider perspective, the emphasis is on treating the major problems—diabetes, hypertension—and rhinitis is considered a minor problem. So I don’t think we are educating our patients well enough. And I think that is a misconception and misunderstanding, which should be corrected.

Dr. Stoloff: Most physicians will see on their schedule a brief description of what problems their upcoming patients have. In primary care, the person filling the schedule will often say that the patient with nasal symptoms has sinusitis, which overwhelmingly it is not. That is an “easy” quick visit and the typical conversation is “Here, take this pill—if you’ve tried that pill, then take this nasal inhaler—and if you didn’t like this one I’ve got another sample for you. And then we’ll figure out which one is going to be on your list, what is covered by your insurance, and what’s the generic.” There is very little discussion about the type of impairment suffered and the overall burden on the individual. Importantly, that burden is often substantial, especially if nasal allergy symptoms were the primary reason for the office visit.

In primary care, people can have a multitude of other conditions, and allergic rhinitis is down at the bottom of the list. For example, the patient may be a hypertensive diabetic who also has seasonal allergic rhinitis. So by the time a family doctor gets to discuss allergic rhinitis, the office visit time is over and it is easier for the physician to just give a medication. But when the presence of allergic rhinitis has an enormous influence on the other diseases as far as activity, sleep, fatigue, depression, all the other emotional components, as well as physical components, that the survey highlighted—that really needs to be brought to the attention of both the patient and the health care provider to spend the appropriate time discussing it. Because it will influence care in everything else the person does.

How would you work up a patient who you might consider as potentially having allergic rhinitis?

Dr. Meltzer: When physicians view their schedule, a word or phrase supposedly informs them in advance of the patient’s condition. In reality, every patient is different and, moreover, patients with allergic rhinitis vary over the course of days, months and years in their symptomatology. So when I evaluate a patient for rhinitis and their chief complaint is “I’m having problems with my nose,” I first find out the full range of symptoms, and which symptom is for them the most bothersome (most often it will turn out to be congestion). Secondly, I would find out whether the symptoms are intermittent, or persistent. If they are fairly persistent, this informs me about somewhat of their severity, which is another very important consideration. Thirdly, I would try to find out what are the triggers for the symptoms such as non-allergic precipitants (eg, climate changes, tobacco smoke, and other environmental pollutants), or specific allergen triggers (eg, pets, springtime pollens). I would also ask about any comorbid conditions because if they are having more than just nasal symptoms that expands what I am going to need to address. I need to know all of those things before I make a treatment plan. If the disease is intermittent and mild or not very bothersome, then I am going to initiate a modest management plan. If their allergic rhinitis is more problematic, then I will need to educate the patient about what they have, why they have it and what to do about it. The patient and I will need to agree about our expectations of treatment. We are going to have an action plan for the short-term as well as a plan for follow-up visits to see if in fact our initial plan is successful. Again, the specifics will depend upon the individual patient.

Dr. Hadley: Many patients come in to an ENT clinic with an inappropriate initial diagnosis, predominantly with sinus disease, and some of them actually have come in with inappropriately obtained CT scans of the paranasal sinuses because they were presumed to have a chronic sinus infection. Most importantly, many of them have come in with inappropriately administered multiple different courses of antibiotics, which is of concern to me. So I agree with Dr. Meltzer in the need to understand the history of the patient’s symptoms—whether they are intermittent or persistent. I also obtain a family history, which helps me to work out whether the patient has an allergic tendency or not. I also have to look back and see what medications have been tried, what has worked (and not worked) in the past. The timing of the medications is really important, and the patient’s own perceptions about whether they want a medication that is going to be beneficial, or whether they want a simple remedy also plays a role. Also, let’s not forget what Dr. Meltzer also talked about—environmental controls that can be helpful to reduce the patient’s symptomatology as well.

Dr. Stoloff: From my perspective, I’m always impressed how a simple explanation of what allergy actually is, in terms of definition and measurement, creates a totally different dialogue with the patient. When my patients come in, they are often past the point of just administering a medicine, and trying others if it didn’t work—especially now there are so many generic over-the-counter products in oral antihistamines available. As a consequence, I really want to talk to them about what is going on— what is the family history, what is the seasonality of the components. I live at a fairly substantial altitude with little or no humidity, so some of the environmental issues that are very clear in San Diego where Dr. Meltzer practices have no role in my patients. However, some of the people I’ve seen have come in with pages of an expensive serum test that shows positive for certain items that have no influence on the patient’s current environment.

Patient history has to guide our workup. Dr. Hadley’s point about family history was important; we look to document what in fact are the causes. If we can figure out what is pushing the disease forward, maybe we can prevent some of those problems or at least lessen them. The history also helps in diagnosis. If we find by their history they’re overusing topical decongestants, that’s important. If we find they’re using their intranasal spray in the wrong way, that’s important. After obtaining the patient history, we then need to individualize our workup based on physical examination. It is important to look in the nose; if we find they have mechanical problems that’s additional information. Certainly allergic specific testing can be helpful, but it has to be targeted based on the location and based on the patient’s story.

Dr. Meltzer: We also need to target treatment. As Dr. Hadley mentioned, we need to know what has and hasn’t worked in the past and what are the contributing mechanism of the rhinitis for a given patient—is it only allergic, is it infectious, is it nonspecific irritants, is it mechanical, or is it a mixture of all of these. Pharmacologic therapy can be stepped up or stepped down depending upon the patient’s progress. And immunotherapy is certainly an appropriate choice in patients who have more severe disease and/or who are not responding adequately. Individualization is the key in terms of management.

Dr. Hadley: There is a clear need for the identification of and appropriate care of patients who need further management. As clinicians, we glean from patients’ history when they have symptoms and when we can appropriately add to the pharmacological management other therapies that would be beneficial in helping patients control their environment a little bit better during specific times of the year. Some patients do need additional treatment at certain times of the year. For example, whereas patients with intermittent symptoms only need to be treated for a short period of time each year, other patients are plagued with year-round symptoms. So we have to gauge those patients appropriately.

Dr. Stoloff: Another point is that at times comanagement with an allergist or otolaryngologist will be beneficial to the patient. But the primary care physician has to recognize that and it takes time to have that discussion. Unfortunately, because allergic rhinitis is often trivialized (from a health care provider’s point of view), physicians do not step back to see how much of a burden this disease is for that individual. This lessens the opportunity to gain effective consultation in the specific fields, and therefore lessens the opportunity for better health for the patient.

How do current guidelines influence your current treatment practice? Which guidelines are useful?

Dr. Meltzer: The ARIA guidelines originate from a WHO program, initiated in 1999, to create an international appreciation of the morbidity associated with allergic rhinitis. They borrowed from the NIH guidelines for asthma, the classification concept of intermittent and persistent and rating of the disease into mild, moderate, and severe categories. I think that this is clinically more relevant than the FDA classifications of seasonal and perennial allergic rhinitis. If a person suffers symptoms when they visit a family member with cats for 2 weeks over Christmas—then that’s an intermittent problem. It is not really a “perennial” problem in terms of the allergen. The FDA view may be appropriate for approval of medications, but from the management standpoint of patients, classifications of persistent, intermittent and mild, moderate or severe are much more useful. Indeed US guidelines now also use these classifications.

The name ARIA actually stands for Allergic Rhinitis Impact on Asthma, and the impact on asthma was a key driver for the WHO program. ARIA recognized the concept of the unified airway and the consequence that having inflammation in one area of the airway created for other parts of the airway. The guidelines highlighted the recommendation to evaluate patients with allergic rhinitis for lower airway disease (be it with a pulmonary function or at least a good history), and conversely for patients with lower airway disease to check for an upper airway history of problems as well. This is important because there is crosstalk, and we should be managing the whole airway—reducing inflammation in all of it.

Dr. Stoloff: From my viewpoint, very few of my peers are aware of ARIA and what it recommends. Similarly, many of them are not aware of the differences between the FDA classification and clinical guidelines. They simply do not know that the field is moving away from using seasonal and perennial terminology and towards a redefinition in terms of severity, frequency, and intensity.

Dr. Hadley: I agree that the awareness of the ARIA guidelines in general medical communities is low. We should point outthat the American Academy of Asthma, Allergy & Immunology (AAAAI) did publish practice parameters for rhinitis in 2008 and those have made a lot of sense as they give a practitioner a stepwise process to look at whether the symptoms are intermittent versus persistent, the degree of severity, and then makes recommendations on the types of medication that can be of clinical benefit to the patient. These guidelines are much more useful to the primary care physician.

Dr. Stoloff: Speaking as an author of both the ARIA and the AAAAI practice parameters, one of the major problems is that my colleagues in primary care do not routinely read the journals where the guidelines are published. Thus, the information is not disseminated and consequently not incorporated into their clinical practice. If presented and disseminated properly, guidelines should influence the way clinicians look at these health care issues, for the patient’s benefit, for cost benefit, and for improving their practice, gaining better out come for everyone.

Dr. Meltzer: I think there are some common concepts that have been incorporated into each of the guidelines discussed. Firstly, we need to classify people by severity. Secondly, we need to appreciate that people with upper airway disease (including allergic rhinitis), often have involvement of other areas of the respiratory tract. In other words we need to consider the comorbidities of the associated diseases. Thirdly, once we appreciate the magnitude of the problems, the patient together with the clinician needs to establish goals. Fourthly, there are step recommendations; if the symptoms are mild or intermittent, less management is needed. If the symptoms are moderate to severe, and/or persistent, more intensive management is required. There are also defined therapeutic steps as to when one might include immunotherapy as part of the regimen. Finally, patients should be monitored as part of the long-term management of this chronic condition.

The ultimate goal is control—control based on what the patient’s goals were when defined during their discussions with their clinician. If we incorporate those basic five concepts into our clinical practice—it will be good for the upper airway, good for the lower airway, and good for long-term health.

Given the range of products available at present for allergic rhinitis, what criteria influence your choice of product?

Dr. Hadley: The problem is that our patients have problems that they do not consider allergic rhinitis as serious, compared to conditions such as hypertension or diabetes. However, they still have a problem that significantly influences their life. As far as the range of products, many of them have already been on an oral antihistamine and many have used and abused decongestant therapy, which is over-the-counter or now behind-the-counter that they have to ask for. Patients often try to first alleviate their symptoms with some of these products, and by the time the come to see me as a specialist they have already usually started on something already, and I have to look and determine whether or not they would be acceptable to use a more advanced product.

The topical nasal steroid is the pure anti-inflammatory product. We use this to treat the inflammatory state of the patient, recognizing that allergic rhinitis is an inflammatory problem. Antihistamines can reduce some of the symptoms but not as effectively as some of the topical nasal steroids. Added to that patients obviously have a preference to use a single product that they can use once per day, for most Americans this would ideally mean taking a pill, but unfortunately that’s not the best product for them. Our challenge is to change their attitudes and beliefs about appropriate treatment of these problems.

Dr. Meltzer: As an allergist I tend to think about allergic disease not only in terms of what is, but how did it get there. It is important to understand allergic rhinitis as an inflammatory process that involves numerous mediators, cytokines, and inflammatory cells. Oral antihistamines block only one of the mediators; they have no effect on cytokines or inflammatory cells or any of the other mediators. As such, while they can help with itchy noses, sneezing and runny noses, they do not help with congestion— which is the most bothersome and the most frequent symptom. Likewise, anticholinergics only help with runny nose, and are not effective against nasal itch, sneeze or congestion. Most people with allergic rhinitis have chronic disease, and topical decongestants should not be used for prolonged periods of time. Oral decongestants have dose-related side effects and the doses required to effectively reduce congestion increase the risks of irritability, diffculty sleeping and nervousness. Leukotriene modifiers are at best minimal to modest improvers of symptoms. Thus, the intranasal corticosteroids (because of their broad based mechanisms of action) are currently considered to be the best monotherapies.

However, when prescribing intranasal corticosteroids, there are a number of important considerations. First, we should ensure the patient is administering the spray properly in terms of the technique. In addition, there may be some patient preference in terms of whether an individual prefers an aerosol formulation or an aqueous formulation. There may also be issues in regard to cost and related to the availability of different agents on a formulary. Indeed, managed care limitations have been problematic for many of us who take care of patients. Furthermore, we certainly need to monitor that patients adhere to their regimen. I find in my practice that most people do not start taking their medication prior to a season; they wait until they’re in the midst of the worst time of their symptomatology and then expect an immediate treatment effect. I try to explain to them, that allergic rhinitis is an ongoing process, a fire, and if effective therapy is established and maintained early on, then the fire can be kept under control and the outcome will be far better than trying to deal with it when there is a flare-up of the major symptoms. This is a communication issue. Every person may have a different view and we need to come to an understanding of each individuals’ viewpoint (what their goals of treatment are). We are not going to be able to force a patient to stick with a particular treatment. It’s about educating them and encouraging them to take responsibility. I tell them “when you leave my office, you’re the one who has allergic rhinitis and I recommend you take the medication. However, you make the decisions.”

Dr. Hadley: We also must not forget that inappropriate patient comprehension and knowledge can also be problematic. Some patients take their medication too late, or perhaps too long, and they have side effects. Side effects can increase the burden of their disease and impact on their ability to perform well at work or school or play.

Dr. Stoloff: Yes, in primary care, especially when treating the older population who have hypertension, one often sees patients take decongestants, and one realizes the multitude of side effects associated with them. And, as Dr. Hadley says, very few patients are aware that their medications are causing these problems.

There are basically three key aspects related to patient communication. Firstly, patient education; we need to ensure our patients are aware of what they have, why they have it and what they can do about it. Secondly, there needs to be ongoing communication between the patient and the clinician to ensure availability of questions and availability of goal setting. Thirdly, patients should have realistic expectations, because when patients revisit we can assess if we have met their expectations or if adjustments in management are needed.

Dr. Hadley: I agree. Better awareness of the disease burden will improve the patient-clinician discussion and thereby improve the patient-physician relationship. This will enable physicians to better guide their patients through proposed treatment plans.

Another important topic is patient preference. We have discussed that most patients would like a pill that has no side effects or that they can take once a day, perhaps once a week, or a patch that they don’t have to deal with. Unfortunately, we need to recognize that such a medication does not yet exist. Patients who have a problem with the inflammatory process should be seen by the clinician and steered toward the most effective medication, and I personally believe that the topical nasal steroids are the best choice to reduce the inflammatory process as much as possible. There are new aerosol formulations of topical nasal steroids that will bring more treatment options for allergic rhinitis.

Dr. Meltzer: We should also note that these new developments with regards to new delivery systems address expanding patient choice. There are also a number of combination agents and biologics in development that may also improve pharmacotherapeutic outcomes. Advances in immunotherapy will also help treat the basic cause of allergic disease. I think many of these options will become available within the next few years.

Dr. Stoloff: I concur. The other point that we have made, and I think it’s important to reiterate, allergic rhinitis is not in a silo. It is associated with, for most of the population, comorbid diseases. When clinicians look for comorbidities, they often gain a far better appreciation of the value of treating the allergic rhinitis and therefore improving their outcome for other health issues such as asthma. But this needs to be taken in the context of communicating with the patient, always taking patient needs and goals into consideration, and working within the economic health care system that we now face.

Authors of papers presented in this Supplement met in person at the 2011 Annual Meeting of the American College of Allergy, Asthma & Immunology to further discuss the clinical, social, and economic implications of the findings from the Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC. This paper represents an edited transcript of their discussion.

Given the recent changes in US health care, how should the results of the NASAL 2010 survey be used to inform current practice? What about the role of other health care professionals and what are the cost implications of the survey findings?

Dr. Hadley: Firstly, it is important to note that there were improvements in the design of the NASAL 2010 survey compared to its 2006 predecessor. More importantly, although some of the 2010 information was a little bit different, we found that the majority of patients still suffer from their symptoms, and that the symptoms are predominant and bothersome. Allergic rhinitis bothers their sleep; it bothers their work and daily activities. In other words, we have not really seen any difference in achieving a reduction of the patients’ symptoms from 2006 to 2010.

Dr. Meltzer: Looking at this issue more globally, I think that the lack of change has a great deal to do with the public not understanding what “health” is. The World Health Organization (WHO) definition of health is there should be no problems with physical, social, emotional, or mental well-being. Individuals often do not appreciate how healthy they could be, and thus do not have a reference point. The NASAL survey clearly shows that most nasal allergy sufferers are not aware of an appropriate respiratory health goal and, further, they are not cognizant of the magnitude of their disease due to their allergic rhinitis. I believe the patients are not the only ones who are unaware; I think many clinicians are also not aware of the extent of their patients’ morbidity. A current problem is that there is not enough assumption of responsibility; patients are not taking enough responsibility for their health, clinicians are not adequately managing these patients, and—despite the suggested health care reforms—there does not appear to be in the foreseeable future a system that is going to alter these conditions.

Dr. Stoloff: For example, many family physicians only ask the question “How are you (with respect to this topic)?” and patients often say they are fine, and that’s the end of the dialogue. But consequences of this type of discussion are that costs of health care continue due to the lack of health. So the person misses work or the person’s job performance is less than it would be because they don’t recognize what their health could be if they were properly treated. As far as they’re concerned, this situation has been going on year after year, and it is only when they are really bad that they know they should be somewhat better. Even then, most people do not fully appreciate what is achievable because no one in the health care system has ever told them, “You should be able to sleep through the night and wake up feeling well. You should be able to go to work. You should be able to participate in athletic, recreational venues to be healthy.” No one has brought that up, and as long as this situation continues, the cost for the patient, his or her family, and health care will continue to increase.

Dr. Hadley: One of the things that I see as an otolaryngologist is that there is also often a missed diagnosis. Everybody who comes in to see me tells me: “Doctor, I have ‘sinus’.” I think most of them are simply unaware of that fact that their nasal congestion plays a role in developing their sinus symptoms. So there is general unawareness of the importance of treating nasal allergies in the lay public, as well as in primary care physicians who have to deal with these patients. Going to issues of cost, I think that patients are seeing the economy go down, and this means that they don’t want to spend a lot of money on their health care. They have a lot of other worries, and I think this is playing a role in how we have to deal with our patients.

Dr. Stoloff: People need to understand that the cost of not spending money to be healthy has a consequence that is sometimes the greater cost of being unhealthy—cost in terms of morbidity, cost in terms of missed days from work, absenteeism, presenteeism, poor ability to function in the usual domains of physical, social, emotional, and mental.

Dr. Hadley: That’s what the public just does not understand. We have not achieved the goal of informing the lay public and practitioners about how effective management can get these patients better, reduce their costs, and enable patients to go back to work and their activities.

What should be done to better act on the challenges highlighted by these important surveys? Is there a need to increase the awareness of allergic rhinitis among health care providers?

Dr. Meltzer: If we’re not making progress then we have to make some changes. It seems to me that education could drive change. The public needs to better understand that it is not insignificant to have an inflammatory process called allergic rhinitis. Allergic rhinitis is clearly underestimated in terms of its burden. It is too often unrecognized or ignored as an inconsequential problem. It is important that the person who has allergic rhinitis does not disregard the burden of disease. The NASAL survey reports that allergic rhinitis affects the ability to sleep well in 40 of patients. We know that allergic rhinitis also compromises people’s activities and we know that they are not as productive when they’re at work. We also know there are many comorbidities—asthma in particular, and sinusitis, otitis, conjunctivitis are other common associated conditions. Patients and clinicians need to be educated to appreciate the significant morbidity associated with allergic rhinitis, and that nasal allergies need attention and effective control.

Dr. Hadley: One of the things that we all see is patients not always getting important information about the medications that they take; there is a walk-in to the grocery store and the pharmacy shelves are filled with medications that are over-the-counter. The problem is there is not enough education about what the benefits are and what the side effects are of all those medications. There is also a lot of direct to consumer advertising—radio, television, etc., that also leads to misconceptions about the benefits of some of these medications. Patients are somewhat aware that they have a problem, but they just don’t know where to go. From the health care provider perspective, the emphasis is on treating the major problems—diabetes, hypertension—and rhinitis is considered a minor problem. So I don’t think we are educating our patients well enough. And I think that is a misconception and misunderstanding, which should be corrected.

Dr. Stoloff: Most physicians will see on their schedule a brief description of what problems their upcoming patients have. In primary care, the person filling the schedule will often say that the patient with nasal symptoms has sinusitis, which overwhelmingly it is not. That is an “easy” quick visit and the typical conversation is “Here, take this pill—if you’ve tried that pill, then take this nasal inhaler—and if you didn’t like this one I’ve got another sample for you. And then we’ll figure out which one is going to be on your list, what is covered by your insurance, and what’s the generic.” There is very little discussion about the type of impairment suffered and the overall burden on the individual. Importantly, that burden is often substantial, especially if nasal allergy symptoms were the primary reason for the office visit.

In primary care, people can have a multitude of other conditions, and allergic rhinitis is down at the bottom of the list. For example, the patient may be a hypertensive diabetic who also has seasonal allergic rhinitis. So by the time a family doctor gets to discuss allergic rhinitis, the office visit time is over and it is easier for the physician to just give a medication. But when the presence of allergic rhinitis has an enormous influence on the other diseases as far as activity, sleep, fatigue, depression, all the other emotional components, as well as physical components, that the survey highlighted—that really needs to be brought to the attention of both the patient and the health care provider to spend the appropriate time discussing it. Because it will influence care in everything else the person does.

How would you work up a patient who you might consider as potentially having allergic rhinitis?

Dr. Meltzer: When physicians view their schedule, a word or phrase supposedly informs them in advance of the patient’s condition. In reality, every patient is different and, moreover, patients with allergic rhinitis vary over the course of days, months and years in their symptomatology. So when I evaluate a patient for rhinitis and their chief complaint is “I’m having problems with my nose,” I first find out the full range of symptoms, and which symptom is for them the most bothersome (most often it will turn out to be congestion). Secondly, I would find out whether the symptoms are intermittent, or persistent. If they are fairly persistent, this informs me about somewhat of their severity, which is another very important consideration. Thirdly, I would try to find out what are the triggers for the symptoms such as non-allergic precipitants (eg, climate changes, tobacco smoke, and other environmental pollutants), or specific allergen triggers (eg, pets, springtime pollens). I would also ask about any comorbid conditions because if they are having more than just nasal symptoms that expands what I am going to need to address. I need to know all of those things before I make a treatment plan. If the disease is intermittent and mild or not very bothersome, then I am going to initiate a modest management plan. If their allergic rhinitis is more problematic, then I will need to educate the patient about what they have, why they have it and what to do about it. The patient and I will need to agree about our expectations of treatment. We are going to have an action plan for the short-term as well as a plan for follow-up visits to see if in fact our initial plan is successful. Again, the specifics will depend upon the individual patient.

Dr. Hadley: Many patients come in to an ENT clinic with an inappropriate initial diagnosis, predominantly with sinus disease, and some of them actually have come in with inappropriately obtained CT scans of the paranasal sinuses because they were presumed to have a chronic sinus infection. Most importantly, many of them have come in with inappropriately administered multiple different courses of antibiotics, which is of concern to me. So I agree with Dr. Meltzer in the need to understand the history of the patient’s symptoms—whether they are intermittent or persistent. I also obtain a family history, which helps me to work out whether the patient has an allergic tendency or not. I also have to look back and see what medications have been tried, what has worked (and not worked) in the past. The timing of the medications is really important, and the patient’s own perceptions about whether they want a medication that is going to be beneficial, or whether they want a simple remedy also plays a role. Also, let’s not forget what Dr. Meltzer also talked about—environmental controls that can be helpful to reduce the patient’s symptomatology as well.

Dr. Stoloff: From my perspective, I’m always impressed how a simple explanation of what allergy actually is, in terms of definition and measurement, creates a totally different dialogue with the patient. When my patients come in, they are often past the point of just administering a medicine, and trying others if it didn’t work—especially now there are so many generic over-the-counter products in oral antihistamines available. As a consequence, I really want to talk to them about what is going on— what is the family history, what is the seasonality of the components. I live at a fairly substantial altitude with little or no humidity, so some of the environmental issues that are very clear in San Diego where Dr. Meltzer practices have no role in my patients. However, some of the people I’ve seen have come in with pages of an expensive serum test that shows positive for certain items that have no influence on the patient’s current environment.

Patient history has to guide our workup. Dr. Hadley’s point about family history was important; we look to document what in fact are the causes. If we can figure out what is pushing the disease forward, maybe we can prevent some of those problems or at least lessen them. The history also helps in diagnosis. If we find by their history they’re overusing topical decongestants, that’s important. If we find they’re using their intranasal spray in the wrong way, that’s important. After obtaining the patient history, we then need to individualize our workup based on physical examination. It is important to look in the nose; if we find they have mechanical problems that’s additional information. Certainly allergic specific testing can be helpful, but it has to be targeted based on the location and based on the patient’s story.

Dr. Meltzer: We also need to target treatment. As Dr. Hadley mentioned, we need to know what has and hasn’t worked in the past and what are the contributing mechanism of the rhinitis for a given patient—is it only allergic, is it infectious, is it nonspecific irritants, is it mechanical, or is it a mixture of all of these. Pharmacologic therapy can be stepped up or stepped down depending upon the patient’s progress. And immunotherapy is certainly an appropriate choice in patients who have more severe disease and/or who are not responding adequately. Individualization is the key in terms of management.

Dr. Hadley: There is a clear need for the identification of and appropriate care of patients who need further management. As clinicians, we glean from patients’ history when they have symptoms and when we can appropriately add to the pharmacological management other therapies that would be beneficial in helping patients control their environment a little bit better during specific times of the year. Some patients do need additional treatment at certain times of the year. For example, whereas patients with intermittent symptoms only need to be treated for a short period of time each year, other patients are plagued with year-round symptoms. So we have to gauge those patients appropriately.

Dr. Stoloff: Another point is that at times comanagement with an allergist or otolaryngologist will be beneficial to the patient. But the primary care physician has to recognize that and it takes time to have that discussion. Unfortunately, because allergic rhinitis is often trivialized (from a health care provider’s point of view), physicians do not step back to see how much of a burden this disease is for that individual. This lessens the opportunity to gain effective consultation in the specific fields, and therefore lessens the opportunity for better health for the patient.

How do current guidelines influence your current treatment practice? Which guidelines are useful?

Dr. Meltzer: The ARIA guidelines originate from a WHO program, initiated in 1999, to create an international appreciation of the morbidity associated with allergic rhinitis. They borrowed from the NIH guidelines for asthma, the classification concept of intermittent and persistent and rating of the disease into mild, moderate, and severe categories. I think that this is clinically more relevant than the FDA classifications of seasonal and perennial allergic rhinitis. If a person suffers symptoms when they visit a family member with cats for 2 weeks over Christmas—then that’s an intermittent problem. It is not really a “perennial” problem in terms of the allergen. The FDA view may be appropriate for approval of medications, but from the management standpoint of patients, classifications of persistent, intermittent and mild, moderate or severe are much more useful. Indeed US guidelines now also use these classifications.

The name ARIA actually stands for Allergic Rhinitis Impact on Asthma, and the impact on asthma was a key driver for the WHO program. ARIA recognized the concept of the unified airway and the consequence that having inflammation in one area of the airway created for other parts of the airway. The guidelines highlighted the recommendation to evaluate patients with allergic rhinitis for lower airway disease (be it with a pulmonary function or at least a good history), and conversely for patients with lower airway disease to check for an upper airway history of problems as well. This is important because there is crosstalk, and we should be managing the whole airway—reducing inflammation in all of it.

Dr. Stoloff: From my viewpoint, very few of my peers are aware of ARIA and what it recommends. Similarly, many of them are not aware of the differences between the FDA classification and clinical guidelines. They simply do not know that the field is moving away from using seasonal and perennial terminology and towards a redefinition in terms of severity, frequency, and intensity.

Dr. Hadley: I agree that the awareness of the ARIA guidelines in general medical communities is low. We should point outthat the American Academy of Asthma, Allergy & Immunology (AAAAI) did publish practice parameters for rhinitis in 2008 and those have made a lot of sense as they give a practitioner a stepwise process to look at whether the symptoms are intermittent versus persistent, the degree of severity, and then makes recommendations on the types of medication that can be of clinical benefit to the patient. These guidelines are much more useful to the primary care physician.

Dr. Stoloff: Speaking as an author of both the ARIA and the AAAAI practice parameters, one of the major problems is that my colleagues in primary care do not routinely read the journals where the guidelines are published. Thus, the information is not disseminated and consequently not incorporated into their clinical practice. If presented and disseminated properly, guidelines should influence the way clinicians look at these health care issues, for the patient’s benefit, for cost benefit, and for improving their practice, gaining better out come for everyone.

Dr. Meltzer: I think there are some common concepts that have been incorporated into each of the guidelines discussed. Firstly, we need to classify people by severity. Secondly, we need to appreciate that people with upper airway disease (including allergic rhinitis), often have involvement of other areas of the respiratory tract. In other words we need to consider the comorbidities of the associated diseases. Thirdly, once we appreciate the magnitude of the problems, the patient together with the clinician needs to establish goals. Fourthly, there are step recommendations; if the symptoms are mild or intermittent, less management is needed. If the symptoms are moderate to severe, and/or persistent, more intensive management is required. There are also defined therapeutic steps as to when one might include immunotherapy as part of the regimen. Finally, patients should be monitored as part of the long-term management of this chronic condition.

The ultimate goal is control—control based on what the patient’s goals were when defined during their discussions with their clinician. If we incorporate those basic five concepts into our clinical practice—it will be good for the upper airway, good for the lower airway, and good for long-term health.

Given the range of products available at present for allergic rhinitis, what criteria influence your choice of product?

Dr. Hadley: The problem is that our patients have problems that they do not consider allergic rhinitis as serious, compared to conditions such as hypertension or diabetes. However, they still have a problem that significantly influences their life. As far as the range of products, many of them have already been on an oral antihistamine and many have used and abused decongestant therapy, which is over-the-counter or now behind-the-counter that they have to ask for. Patients often try to first alleviate their symptoms with some of these products, and by the time the come to see me as a specialist they have already usually started on something already, and I have to look and determine whether or not they would be acceptable to use a more advanced product.

The topical nasal steroid is the pure anti-inflammatory product. We use this to treat the inflammatory state of the patient, recognizing that allergic rhinitis is an inflammatory problem. Antihistamines can reduce some of the symptoms but not as effectively as some of the topical nasal steroids. Added to that patients obviously have a preference to use a single product that they can use once per day, for most Americans this would ideally mean taking a pill, but unfortunately that’s not the best product for them. Our challenge is to change their attitudes and beliefs about appropriate treatment of these problems.

Dr. Meltzer: As an allergist I tend to think about allergic disease not only in terms of what is, but how did it get there. It is important to understand allergic rhinitis as an inflammatory process that involves numerous mediators, cytokines, and inflammatory cells. Oral antihistamines block only one of the mediators; they have no effect on cytokines or inflammatory cells or any of the other mediators. As such, while they can help with itchy noses, sneezing and runny noses, they do not help with congestion— which is the most bothersome and the most frequent symptom. Likewise, anticholinergics only help with runny nose, and are not effective against nasal itch, sneeze or congestion. Most people with allergic rhinitis have chronic disease, and topical decongestants should not be used for prolonged periods of time. Oral decongestants have dose-related side effects and the doses required to effectively reduce congestion increase the risks of irritability, diffculty sleeping and nervousness. Leukotriene modifiers are at best minimal to modest improvers of symptoms. Thus, the intranasal corticosteroids (because of their broad based mechanisms of action) are currently considered to be the best monotherapies.

However, when prescribing intranasal corticosteroids, there are a number of important considerations. First, we should ensure the patient is administering the spray properly in terms of the technique. In addition, there may be some patient preference in terms of whether an individual prefers an aerosol formulation or an aqueous formulation. There may also be issues in regard to cost and related to the availability of different agents on a formulary. Indeed, managed care limitations have been problematic for many of us who take care of patients. Furthermore, we certainly need to monitor that patients adhere to their regimen. I find in my practice that most people do not start taking their medication prior to a season; they wait until they’re in the midst of the worst time of their symptomatology and then expect an immediate treatment effect. I try to explain to them, that allergic rhinitis is an ongoing process, a fire, and if effective therapy is established and maintained early on, then the fire can be kept under control and the outcome will be far better than trying to deal with it when there is a flare-up of the major symptoms. This is a communication issue. Every person may have a different view and we need to come to an understanding of each individuals’ viewpoint (what their goals of treatment are). We are not going to be able to force a patient to stick with a particular treatment. It’s about educating them and encouraging them to take responsibility. I tell them “when you leave my office, you’re the one who has allergic rhinitis and I recommend you take the medication. However, you make the decisions.”

Dr. Hadley: We also must not forget that inappropriate patient comprehension and knowledge can also be problematic. Some patients take their medication too late, or perhaps too long, and they have side effects. Side effects can increase the burden of their disease and impact on their ability to perform well at work or school or play.

Dr. Stoloff: Yes, in primary care, especially when treating the older population who have hypertension, one often sees patients take decongestants, and one realizes the multitude of side effects associated with them. And, as Dr. Hadley says, very few patients are aware that their medications are causing these problems.

There are basically three key aspects related to patient communication. Firstly, patient education; we need to ensure our patients are aware of what they have, why they have it and what they can do about it. Secondly, there needs to be ongoing communication between the patient and the clinician to ensure availability of questions and availability of goal setting. Thirdly, patients should have realistic expectations, because when patients revisit we can assess if we have met their expectations or if adjustments in management are needed.

Dr. Hadley: I agree. Better awareness of the disease burden will improve the patient-clinician discussion and thereby improve the patient-physician relationship. This will enable physicians to better guide their patients through proposed treatment plans.

Another important topic is patient preference. We have discussed that most patients would like a pill that has no side effects or that they can take once a day, perhaps once a week, or a patch that they don’t have to deal with. Unfortunately, we need to recognize that such a medication does not yet exist. Patients who have a problem with the inflammatory process should be seen by the clinician and steered toward the most effective medication, and I personally believe that the topical nasal steroids are the best choice to reduce the inflammatory process as much as possible. There are new aerosol formulations of topical nasal steroids that will bring more treatment options for allergic rhinitis.

Dr. Meltzer: We should also note that these new developments with regards to new delivery systems address expanding patient choice. There are also a number of combination agents and biologics in development that may also improve pharmacotherapeutic outcomes. Advances in immunotherapy will also help treat the basic cause of allergic disease. I think many of these options will become available within the next few years.

Dr. Stoloff: I concur. The other point that we have made, and I think it’s important to reiterate, allergic rhinitis is not in a silo. It is associated with, for most of the population, comorbid diseases. When clinicians look for comorbidities, they often gain a far better appreciation of the value of treating the allergic rhinitis and therefore improving their outcome for other health issues such as asthma. But this needs to be taken in the context of communicating with the patient, always taking patient needs and goals into consideration, and working within the economic health care system that we now face.

Authors of papers presented in this Supplement met in person at the 2011 Annual Meeting of the American College of Allergy, Asthma & Immunology to further discuss the clinical, social, and economic implications of the findings from the Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC. This paper represents an edited transcript of their discussion.

Given the recent changes in US health care, how should the results of the NASAL 2010 survey be used to inform current practice? What about the role of other health care professionals and what are the cost implications of the survey findings?

Dr. Hadley: Firstly, it is important to note that there were improvements in the design of the NASAL 2010 survey compared to its 2006 predecessor. More importantly, although some of the 2010 information was a little bit different, we found that the majority of patients still suffer from their symptoms, and that the symptoms are predominant and bothersome. Allergic rhinitis bothers their sleep; it bothers their work and daily activities. In other words, we have not really seen any difference in achieving a reduction of the patients’ symptoms from 2006 to 2010.

Dr. Meltzer: Looking at this issue more globally, I think that the lack of change has a great deal to do with the public not understanding what “health” is. The World Health Organization (WHO) definition of health is there should be no problems with physical, social, emotional, or mental well-being. Individuals often do not appreciate how healthy they could be, and thus do not have a reference point. The NASAL survey clearly shows that most nasal allergy sufferers are not aware of an appropriate respiratory health goal and, further, they are not cognizant of the magnitude of their disease due to their allergic rhinitis. I believe the patients are not the only ones who are unaware; I think many clinicians are also not aware of the extent of their patients’ morbidity. A current problem is that there is not enough assumption of responsibility; patients are not taking enough responsibility for their health, clinicians are not adequately managing these patients, and—despite the suggested health care reforms—there does not appear to be in the foreseeable future a system that is going to alter these conditions.

Dr. Stoloff: For example, many family physicians only ask the question “How are you (with respect to this topic)?” and patients often say they are fine, and that’s the end of the dialogue. But consequences of this type of discussion are that costs of health care continue due to the lack of health. So the person misses work or the person’s job performance is less than it would be because they don’t recognize what their health could be if they were properly treated. As far as they’re concerned, this situation has been going on year after year, and it is only when they are really bad that they know they should be somewhat better. Even then, most people do not fully appreciate what is achievable because no one in the health care system has ever told them, “You should be able to sleep through the night and wake up feeling well. You should be able to go to work. You should be able to participate in athletic, recreational venues to be healthy.” No one has brought that up, and as long as this situation continues, the cost for the patient, his or her family, and health care will continue to increase.

Dr. Hadley: One of the things that I see as an otolaryngologist is that there is also often a missed diagnosis. Everybody who comes in to see me tells me: “Doctor, I have ‘sinus’.” I think most of them are simply unaware of that fact that their nasal congestion plays a role in developing their sinus symptoms. So there is general unawareness of the importance of treating nasal allergies in the lay public, as well as in primary care physicians who have to deal with these patients. Going to issues of cost, I think that patients are seeing the economy go down, and this means that they don’t want to spend a lot of money on their health care. They have a lot of other worries, and I think this is playing a role in how we have to deal with our patients.

Dr. Stoloff: People need to understand that the cost of not spending money to be healthy has a consequence that is sometimes the greater cost of being unhealthy—cost in terms of morbidity, cost in terms of missed days from work, absenteeism, presenteeism, poor ability to function in the usual domains of physical, social, emotional, and mental.

Dr. Hadley: That’s what the public just does not understand. We have not achieved the goal of informing the lay public and practitioners about how effective management can get these patients better, reduce their costs, and enable patients to go back to work and their activities.

What should be done to better act on the challenges highlighted by these important surveys? Is there a need to increase the awareness of allergic rhinitis among health care providers?

Dr. Meltzer: If we’re not making progress then we have to make some changes. It seems to me that education could drive change. The public needs to better understand that it is not insignificant to have an inflammatory process called allergic rhinitis. Allergic rhinitis is clearly underestimated in terms of its burden. It is too often unrecognized or ignored as an inconsequential problem. It is important that the person who has allergic rhinitis does not disregard the burden of disease. The NASAL survey reports that allergic rhinitis affects the ability to sleep well in 40 of patients. We know that allergic rhinitis also compromises people’s activities and we know that they are not as productive when they’re at work. We also know there are many comorbidities—asthma in particular, and sinusitis, otitis, conjunctivitis are other common associated conditions. Patients and clinicians need to be educated to appreciate the significant morbidity associated with allergic rhinitis, and that nasal allergies need attention and effective control.

Dr. Hadley: One of the things that we all see is patients not always getting important information about the medications that they take; there is a walk-in to the grocery store and the pharmacy shelves are filled with medications that are over-the-counter. The problem is there is not enough education about what the benefits are and what the side effects are of all those medications. There is also a lot of direct to consumer advertising—radio, television, etc., that also leads to misconceptions about the benefits of some of these medications. Patients are somewhat aware that they have a problem, but they just don’t know where to go. From the health care provider perspective, the emphasis is on treating the major problems—diabetes, hypertension—and rhinitis is considered a minor problem. So I don’t think we are educating our patients well enough. And I think that is a misconception and misunderstanding, which should be corrected.

Dr. Stoloff: Most physicians will see on their schedule a brief description of what problems their upcoming patients have. In primary care, the person filling the schedule will often say that the patient with nasal symptoms has sinusitis, which overwhelmingly it is not. That is an “easy” quick visit and the typical conversation is “Here, take this pill—if you’ve tried that pill, then take this nasal inhaler—and if you didn’t like this one I’ve got another sample for you. And then we’ll figure out which one is going to be on your list, what is covered by your insurance, and what’s the generic.” There is very little discussion about the type of impairment suffered and the overall burden on the individual. Importantly, that burden is often substantial, especially if nasal allergy symptoms were the primary reason for the office visit.

In primary care, people can have a multitude of other conditions, and allergic rhinitis is down at the bottom of the list. For example, the patient may be a hypertensive diabetic who also has seasonal allergic rhinitis. So by the time a family doctor gets to discuss allergic rhinitis, the office visit time is over and it is easier for the physician to just give a medication. But when the presence of allergic rhinitis has an enormous influence on the other diseases as far as activity, sleep, fatigue, depression, all the other emotional components, as well as physical components, that the survey highlighted—that really needs to be brought to the attention of both the patient and the health care provider to spend the appropriate time discussing it. Because it will influence care in everything else the person does.

How would you work up a patient who you might consider as potentially having allergic rhinitis?

Dr. Meltzer: When physicians view their schedule, a word or phrase supposedly informs them in advance of the patient’s condition. In reality, every patient is different and, moreover, patients with allergic rhinitis vary over the course of days, months and years in their symptomatology. So when I evaluate a patient for rhinitis and their chief complaint is “I’m having problems with my nose,” I first find out the full range of symptoms, and which symptom is for them the most bothersome (most often it will turn out to be congestion). Secondly, I would find out whether the symptoms are intermittent, or persistent. If they are fairly persistent, this informs me about somewhat of their severity, which is another very important consideration. Thirdly, I would try to find out what are the triggers for the symptoms such as non-allergic precipitants (eg, climate changes, tobacco smoke, and other environmental pollutants), or specific allergen triggers (eg, pets, springtime pollens). I would also ask about any comorbid conditions because if they are having more than just nasal symptoms that expands what I am going to need to address. I need to know all of those things before I make a treatment plan. If the disease is intermittent and mild or not very bothersome, then I am going to initiate a modest management plan. If their allergic rhinitis is more problematic, then I will need to educate the patient about what they have, why they have it and what to do about it. The patient and I will need to agree about our expectations of treatment. We are going to have an action plan for the short-term as well as a plan for follow-up visits to see if in fact our initial plan is successful. Again, the specifics will depend upon the individual patient.

Dr. Hadley: Many patients come in to an ENT clinic with an inappropriate initial diagnosis, predominantly with sinus disease, and some of them actually have come in with inappropriately obtained CT scans of the paranasal sinuses because they were presumed to have a chronic sinus infection. Most importantly, many of them have come in with inappropriately administered multiple different courses of antibiotics, which is of concern to me. So I agree with Dr. Meltzer in the need to understand the history of the patient’s symptoms—whether they are intermittent or persistent. I also obtain a family history, which helps me to work out whether the patient has an allergic tendency or not. I also have to look back and see what medications have been tried, what has worked (and not worked) in the past. The timing of the medications is really important, and the patient’s own perceptions about whether they want a medication that is going to be beneficial, or whether they want a simple remedy also plays a role. Also, let’s not forget what Dr. Meltzer also talked about—environmental controls that can be helpful to reduce the patient’s symptomatology as well.

Dr. Stoloff: From my perspective, I’m always impressed how a simple explanation of what allergy actually is, in terms of definition and measurement, creates a totally different dialogue with the patient. When my patients come in, they are often past the point of just administering a medicine, and trying others if it didn’t work—especially now there are so many generic over-the-counter products in oral antihistamines available. As a consequence, I really want to talk to them about what is going on— what is the family history, what is the seasonality of the components. I live at a fairly substantial altitude with little or no humidity, so some of the environmental issues that are very clear in San Diego where Dr. Meltzer practices have no role in my patients. However, some of the people I’ve seen have come in with pages of an expensive serum test that shows positive for certain items that have no influence on the patient’s current environment.

Patient history has to guide our workup. Dr. Hadley’s point about family history was important; we look to document what in fact are the causes. If we can figure out what is pushing the disease forward, maybe we can prevent some of those problems or at least lessen them. The history also helps in diagnosis. If we find by their history they’re overusing topical decongestants, that’s important. If we find they’re using their intranasal spray in the wrong way, that’s important. After obtaining the patient history, we then need to individualize our workup based on physical examination. It is important to look in the nose; if we find they have mechanical problems that’s additional information. Certainly allergic specific testing can be helpful, but it has to be targeted based on the location and based on the patient’s story.

Dr. Meltzer: We also need to target treatment. As Dr. Hadley mentioned, we need to know what has and hasn’t worked in the past and what are the contributing mechanism of the rhinitis for a given patient—is it only allergic, is it infectious, is it nonspecific irritants, is it mechanical, or is it a mixture of all of these. Pharmacologic therapy can be stepped up or stepped down depending upon the patient’s progress. And immunotherapy is certainly an appropriate choice in patients who have more severe disease and/or who are not responding adequately. Individualization is the key in terms of management.

Dr. Hadley: There is a clear need for the identification of and appropriate care of patients who need further management. As clinicians, we glean from patients’ history when they have symptoms and when we can appropriately add to the pharmacological management other therapies that would be beneficial in helping patients control their environment a little bit better during specific times of the year. Some patients do need additional treatment at certain times of the year. For example, whereas patients with intermittent symptoms only need to be treated for a short period of time each year, other patients are plagued with year-round symptoms. So we have to gauge those patients appropriately.

Dr. Stoloff: Another point is that at times comanagement with an allergist or otolaryngologist will be beneficial to the patient. But the primary care physician has to recognize that and it takes time to have that discussion. Unfortunately, because allergic rhinitis is often trivialized (from a health care provider’s point of view), physicians do not step back to see how much of a burden this disease is for that individual. This lessens the opportunity to gain effective consultation in the specific fields, and therefore lessens the opportunity for better health for the patient.

How do current guidelines influence your current treatment practice? Which guidelines are useful?

Dr. Meltzer: The ARIA guidelines originate from a WHO program, initiated in 1999, to create an international appreciation of the morbidity associated with allergic rhinitis. They borrowed from the NIH guidelines for asthma, the classification concept of intermittent and persistent and rating of the disease into mild, moderate, and severe categories. I think that this is clinically more relevant than the FDA classifications of seasonal and perennial allergic rhinitis. If a person suffers symptoms when they visit a family member with cats for 2 weeks over Christmas—then that’s an intermittent problem. It is not really a “perennial” problem in terms of the allergen. The FDA view may be appropriate for approval of medications, but from the management standpoint of patients, classifications of persistent, intermittent and mild, moderate or severe are much more useful. Indeed US guidelines now also use these classifications.

The name ARIA actually stands for Allergic Rhinitis Impact on Asthma, and the impact on asthma was a key driver for the WHO program. ARIA recognized the concept of the unified airway and the consequence that having inflammation in one area of the airway created for other parts of the airway. The guidelines highlighted the recommendation to evaluate patients with allergic rhinitis for lower airway disease (be it with a pulmonary function or at least a good history), and conversely for patients with lower airway disease to check for an upper airway history of problems as well. This is important because there is crosstalk, and we should be managing the whole airway—reducing inflammation in all of it.

Dr. Stoloff: From my viewpoint, very few of my peers are aware of ARIA and what it recommends. Similarly, many of them are not aware of the differences between the FDA classification and clinical guidelines. They simply do not know that the field is moving away from using seasonal and perennial terminology and towards a redefinition in terms of severity, frequency, and intensity.

Dr. Hadley: I agree that the awareness of the ARIA guidelines in general medical communities is low. We should point outthat the American Academy of Asthma, Allergy & Immunology (AAAAI) did publish practice parameters for rhinitis in 2008 and those have made a lot of sense as they give a practitioner a stepwise process to look at whether the symptoms are intermittent versus persistent, the degree of severity, and then makes recommendations on the types of medication that can be of clinical benefit to the patient. These guidelines are much more useful to the primary care physician.

Dr. Stoloff: Speaking as an author of both the ARIA and the AAAAI practice parameters, one of the major problems is that my colleagues in primary care do not routinely read the journals where the guidelines are published. Thus, the information is not disseminated and consequently not incorporated into their clinical practice. If presented and disseminated properly, guidelines should influence the way clinicians look at these health care issues, for the patient’s benefit, for cost benefit, and for improving their practice, gaining better out come for everyone.

Dr. Meltzer: I think there are some common concepts that have been incorporated into each of the guidelines discussed. Firstly, we need to classify people by severity. Secondly, we need to appreciate that people with upper airway disease (including allergic rhinitis), often have involvement of other areas of the respiratory tract. In other words we need to consider the comorbidities of the associated diseases. Thirdly, once we appreciate the magnitude of the problems, the patient together with the clinician needs to establish goals. Fourthly, there are step recommendations; if the symptoms are mild or intermittent, less management is needed. If the symptoms are moderate to severe, and/or persistent, more intensive management is required. There are also defined therapeutic steps as to when one might include immunotherapy as part of the regimen. Finally, patients should be monitored as part of the long-term management of this chronic condition.

The ultimate goal is control—control based on what the patient’s goals were when defined during their discussions with their clinician. If we incorporate those basic five concepts into our clinical practice—it will be good for the upper airway, good for the lower airway, and good for long-term health.

Given the range of products available at present for allergic rhinitis, what criteria influence your choice of product?

Dr. Hadley: The problem is that our patients have problems that they do not consider allergic rhinitis as serious, compared to conditions such as hypertension or diabetes. However, they still have a problem that significantly influences their life. As far as the range of products, many of them have already been on an oral antihistamine and many have used and abused decongestant therapy, which is over-the-counter or now behind-the-counter that they have to ask for. Patients often try to first alleviate their symptoms with some of these products, and by the time the come to see me as a specialist they have already usually started on something already, and I have to look and determine whether or not they would be acceptable to use a more advanced product.

The topical nasal steroid is the pure anti-inflammatory product. We use this to treat the inflammatory state of the patient, recognizing that allergic rhinitis is an inflammatory problem. Antihistamines can reduce some of the symptoms but not as effectively as some of the topical nasal steroids. Added to that patients obviously have a preference to use a single product that they can use once per day, for most Americans this would ideally mean taking a pill, but unfortunately that’s not the best product for them. Our challenge is to change their attitudes and beliefs about appropriate treatment of these problems.

Dr. Meltzer: As an allergist I tend to think about allergic disease not only in terms of what is, but how did it get there. It is important to understand allergic rhinitis as an inflammatory process that involves numerous mediators, cytokines, and inflammatory cells. Oral antihistamines block only one of the mediators; they have no effect on cytokines or inflammatory cells or any of the other mediators. As such, while they can help with itchy noses, sneezing and runny noses, they do not help with congestion— which is the most bothersome and the most frequent symptom. Likewise, anticholinergics only help with runny nose, and are not effective against nasal itch, sneeze or congestion. Most people with allergic rhinitis have chronic disease, and topical decongestants should not be used for prolonged periods of time. Oral decongestants have dose-related side effects and the doses required to effectively reduce congestion increase the risks of irritability, diffculty sleeping and nervousness. Leukotriene modifiers are at best minimal to modest improvers of symptoms. Thus, the intranasal corticosteroids (because of their broad based mechanisms of action) are currently considered to be the best monotherapies.

However, when prescribing intranasal corticosteroids, there are a number of important considerations. First, we should ensure the patient is administering the spray properly in terms of the technique. In addition, there may be some patient preference in terms of whether an individual prefers an aerosol formulation or an aqueous formulation. There may also be issues in regard to cost and related to the availability of different agents on a formulary. Indeed, managed care limitations have been problematic for many of us who take care of patients. Furthermore, we certainly need to monitor that patients adhere to their regimen. I find in my practice that most people do not start taking their medication prior to a season; they wait until they’re in the midst of the worst time of their symptomatology and then expect an immediate treatment effect. I try to explain to them, that allergic rhinitis is an ongoing process, a fire, and if effective therapy is established and maintained early on, then the fire can be kept under control and the outcome will be far better than trying to deal with it when there is a flare-up of the major symptoms. This is a communication issue. Every person may have a different view and we need to come to an understanding of each individuals’ viewpoint (what their goals of treatment are). We are not going to be able to force a patient to stick with a particular treatment. It’s about educating them and encouraging them to take responsibility. I tell them “when you leave my office, you’re the one who has allergic rhinitis and I recommend you take the medication. However, you make the decisions.”

Dr. Hadley: We also must not forget that inappropriate patient comprehension and knowledge can also be problematic. Some patients take their medication too late, or perhaps too long, and they have side effects. Side effects can increase the burden of their disease and impact on their ability to perform well at work or school or play.

Dr. Stoloff: Yes, in primary care, especially when treating the older population who have hypertension, one often sees patients take decongestants, and one realizes the multitude of side effects associated with them. And, as Dr. Hadley says, very few patients are aware that their medications are causing these problems.

There are basically three key aspects related to patient communication. Firstly, patient education; we need to ensure our patients are aware of what they have, why they have it and what they can do about it. Secondly, there needs to be ongoing communication between the patient and the clinician to ensure availability of questions and availability of goal setting. Thirdly, patients should have realistic expectations, because when patients revisit we can assess if we have met their expectations or if adjustments in management are needed.

Dr. Hadley: I agree. Better awareness of the disease burden will improve the patient-clinician discussion and thereby improve the patient-physician relationship. This will enable physicians to better guide their patients through proposed treatment plans.

Another important topic is patient preference. We have discussed that most patients would like a pill that has no side effects or that they can take once a day, perhaps once a week, or a patch that they don’t have to deal with. Unfortunately, we need to recognize that such a medication does not yet exist. Patients who have a problem with the inflammatory process should be seen by the clinician and steered toward the most effective medication, and I personally believe that the topical nasal steroids are the best choice to reduce the inflammatory process as much as possible. There are new aerosol formulations of topical nasal steroids that will bring more treatment options for allergic rhinitis.

Dr. Meltzer: We should also note that these new developments with regards to new delivery systems address expanding patient choice. There are also a number of combination agents and biologics in development that may also improve pharmacotherapeutic outcomes. Advances in immunotherapy will also help treat the basic cause of allergic disease. I think many of these options will become available within the next few years.

Dr. Stoloff: I concur. The other point that we have made, and I think it’s important to reiterate, allergic rhinitis is not in a silo. It is associated with, for most of the population, comorbid diseases. When clinicians look for comorbidities, they often gain a far better appreciation of the value of treating the allergic rhinitis and therefore improving their outcome for other health issues such as asthma. But this needs to be taken in the context of communicating with the patient, always taking patient needs and goals into consideration, and working within the economic health care system that we now face.

Authors of papers presented in this Supplement met in person at the 2011 Annual Meeting of the American College of Allergy, Asthma & Immunology to further discuss the clinical, social, and economic implications of the findings from the Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC. This paper represents an edited transcript of their discussion.

Given the recent changes in US health care, how should the results of the NASAL 2010 survey be used to inform current practice? What about the role of other health care professionals and what are the cost implications of the survey findings?

Dr. Hadley: Firstly, it is important to note that there were improvements in the design of the NASAL 2010 survey compared to its 2006 predecessor. More importantly, although some of the 2010 information was a little bit different, we found that the majority of patients still suffer from their symptoms, and that the symptoms are predominant and bothersome. Allergic rhinitis bothers their sleep; it bothers their work and daily activities. In other words, we have not really seen any difference in achieving a reduction of the patients’ symptoms from 2006 to 2010.

Dr. Meltzer: Looking at this issue more globally, I think that the lack of change has a great deal to do with the public not understanding what “health” is. The World Health Organization (WHO) definition of health is there should be no problems with physical, social, emotional, or mental well-being. Individuals often do not appreciate how healthy they could be, and thus do not have a reference point. The NASAL survey clearly shows that most nasal allergy sufferers are not aware of an appropriate respiratory health goal and, further, they are not cognizant of the magnitude of their disease due to their allergic rhinitis. I believe the patients are not the only ones who are unaware; I think many clinicians are also not aware of the extent of their patients’ morbidity. A current problem is that there is not enough assumption of responsibility; patients are not taking enough responsibility for their health, clinicians are not adequately managing these patients, and—despite the suggested health care reforms—there does not appear to be in the foreseeable future a system that is going to alter these conditions.

Dr. Stoloff: For example, many family physicians only ask the question “How are you (with respect to this topic)?” and patients often say they are fine, and that’s the end of the dialogue. But consequences of this type of discussion are that costs of health care continue due to the lack of health. So the person misses work or the person’s job performance is less than it would be because they don’t recognize what their health could be if they were properly treated. As far as they’re concerned, this situation has been going on year after year, and it is only when they are really bad that they know they should be somewhat better. Even then, most people do not fully appreciate what is achievable because no one in the health care system has ever told them, “You should be able to sleep through the night and wake up feeling well. You should be able to go to work. You should be able to participate in athletic, recreational venues to be healthy.” No one has brought that up, and as long as this situation continues, the cost for the patient, his or her family, and health care will continue to increase.

Dr. Hadley: One of the things that I see as an otolaryngologist is that there is also often a missed diagnosis. Everybody who comes in to see me tells me: “Doctor, I have ‘sinus’.” I think most of them are simply unaware of that fact that their nasal congestion plays a role in developing their sinus symptoms. So there is general unawareness of the importance of treating nasal allergies in the lay public, as well as in primary care physicians who have to deal with these patients. Going to issues of cost, I think that patients are seeing the economy go down, and this means that they don’t want to spend a lot of money on their health care. They have a lot of other worries, and I think this is playing a role in how we have to deal with our patients.

Dr. Stoloff: People need to understand that the cost of not spending money to be healthy has a consequence that is sometimes the greater cost of being unhealthy—cost in terms of morbidity, cost in terms of missed days from work, absenteeism, presenteeism, poor ability to function in the usual domains of physical, social, emotional, and mental.

Dr. Hadley: That’s what the public just does not understand. We have not achieved the goal of informing the lay public and practitioners about how effective management can get these patients better, reduce their costs, and enable patients to go back to work and their activities.

What should be done to better act on the challenges highlighted by these important surveys? Is there a need to increase the awareness of allergic rhinitis among health care providers?

Dr. Meltzer: If we’re not making progress then we have to make some changes. It seems to me that education could drive change. The public needs to better understand that it is not insignificant to have an inflammatory process called allergic rhinitis. Allergic rhinitis is clearly underestimated in terms of its burden. It is too often unrecognized or ignored as an inconsequential problem. It is important that the person who has allergic rhinitis does not disregard the burden of disease. The NASAL survey reports that allergic rhinitis affects the ability to sleep well in 40 of patients. We know that allergic rhinitis also compromises people’s activities and we know that they are not as productive when they’re at work. We also know there are many comorbidities—asthma in particular, and sinusitis, otitis, conjunctivitis are other common associated conditions. Patients and clinicians need to be educated to appreciate the significant morbidity associated with allergic rhinitis, and that nasal allergies need attention and effective control.

Dr. Hadley: One of the things that we all see is patients not always getting important information about the medications that they take; there is a walk-in to the grocery store and the pharmacy shelves are filled with medications that are over-the-counter. The problem is there is not enough education about what the benefits are and what the side effects are of all those medications. There is also a lot of direct to consumer advertising—radio, television, etc., that also leads to misconceptions about the benefits of some of these medications. Patients are somewhat aware that they have a problem, but they just don’t know where to go. From the health care provider perspective, the emphasis is on treating the major problems—diabetes, hypertension—and rhinitis is considered a minor problem. So I don’t think we are educating our patients well enough. And I think that is a misconception and misunderstanding, which should be corrected.

Dr. Stoloff: Most physicians will see on their schedule a brief description of what problems their upcoming patients have. In primary care, the person filling the schedule will often say that the patient with nasal symptoms has sinusitis, which overwhelmingly it is not. That is an “easy” quick visit and the typical conversation is “Here, take this pill—if you’ve tried that pill, then take this nasal inhaler—and if you didn’t like this one I’ve got another sample for you. And then we’ll figure out which one is going to be on your list, what is covered by your insurance, and what’s the generic.” There is very little discussion about the type of impairment suffered and the overall burden on the individual. Importantly, that burden is often substantial, especially if nasal allergy symptoms were the primary reason for the office visit.

In primary care, people can have a multitude of other conditions, and allergic rhinitis is down at the bottom of the list. For example, the patient may be a hypertensive diabetic who also has seasonal allergic rhinitis. So by the time a family doctor gets to discuss allergic rhinitis, the office visit time is over and it is easier for the physician to just give a medication. But when the presence of allergic rhinitis has an enormous influence on the other diseases as far as activity, sleep, fatigue, depression, all the other emotional components, as well as physical components, that the survey highlighted—that really needs to be brought to the attention of both the patient and the health care provider to spend the appropriate time discussing it. Because it will influence care in everything else the person does.

How would you work up a patient who you might consider as potentially having allergic rhinitis?

Dr. Meltzer: When physicians view their schedule, a word or phrase supposedly informs them in advance of the patient’s condition. In reality, every patient is different and, moreover, patients with allergic rhinitis vary over the course of days, months and years in their symptomatology. So when I evaluate a patient for rhinitis and their chief complaint is “I’m having problems with my nose,” I first find out the full range of symptoms, and which symptom is for them the most bothersome (most often it will turn out to be congestion). Secondly, I would find out whether the symptoms are intermittent, or persistent. If they are fairly persistent, this informs me about somewhat of their severity, which is another very important consideration. Thirdly, I would try to find out what are the triggers for the symptoms such as non-allergic precipitants (eg, climate changes, tobacco smoke, and other environmental pollutants), or specific allergen triggers (eg, pets, springtime pollens). I would also ask about any comorbid conditions because if they are having more than just nasal symptoms that expands what I am going to need to address. I need to know all of those things before I make a treatment plan. If the disease is intermittent and mild or not very bothersome, then I am going to initiate a modest management plan. If their allergic rhinitis is more problematic, then I will need to educate the patient about what they have, why they have it and what to do about it. The patient and I will need to agree about our expectations of treatment. We are going to have an action plan for the short-term as well as a plan for follow-up visits to see if in fact our initial plan is successful. Again, the specifics will depend upon the individual patient.

Dr. Hadley: Many patients come in to an ENT clinic with an inappropriate initial diagnosis, predominantly with sinus disease, and some of them actually have come in with inappropriately obtained CT scans of the paranasal sinuses because they were presumed to have a chronic sinus infection. Most importantly, many of them have come in with inappropriately administered multiple different courses of antibiotics, which is of concern to me. So I agree with Dr. Meltzer in the need to understand the history of the patient’s symptoms—whether they are intermittent or persistent. I also obtain a family history, which helps me to work out whether the patient has an allergic tendency or not. I also have to look back and see what medications have been tried, what has worked (and not worked) in the past. The timing of the medications is really important, and the patient’s own perceptions about whether they want a medication that is going to be beneficial, or whether they want a simple remedy also plays a role. Also, let’s not forget what Dr. Meltzer also talked about—environmental controls that can be helpful to reduce the patient’s symptomatology as well.

Dr. Stoloff: From my perspective, I’m always impressed how a simple explanation of what allergy actually is, in terms of definition and measurement, creates a totally different dialogue with the patient. When my patients come in, they are often past the point of just administering a medicine, and trying others if it didn’t work—especially now there are so many generic over-the-counter products in oral antihistamines available. As a consequence, I really want to talk to them about what is going on— what is the family history, what is the seasonality of the components. I live at a fairly substantial altitude with little or no humidity, so some of the environmental issues that are very clear in San Diego where Dr. Meltzer practices have no role in my patients. However, some of the people I’ve seen have come in with pages of an expensive serum test that shows positive for certain items that have no influence on the patient’s current environment.

Patient history has to guide our workup. Dr. Hadley’s point about family history was important; we look to document what in fact are the causes. If we can figure out what is pushing the disease forward, maybe we can prevent some of those problems or at least lessen them. The history also helps in diagnosis. If we find by their history they’re overusing topical decongestants, that’s important. If we find they’re using their intranasal spray in the wrong way, that’s important. After obtaining the patient history, we then need to individualize our workup based on physical examination. It is important to look in the nose; if we find they have mechanical problems that’s additional information. Certainly allergic specific testing can be helpful, but it has to be targeted based on the location and based on the patient’s story.

Dr. Meltzer: We also need to target treatment. As Dr. Hadley mentioned, we need to know what has and hasn’t worked in the past and what are the contributing mechanism of the rhinitis for a given patient—is it only allergic, is it infectious, is it nonspecific irritants, is it mechanical, or is it a mixture of all of these. Pharmacologic therapy can be stepped up or stepped down depending upon the patient’s progress. And immunotherapy is certainly an appropriate choice in patients who have more severe disease and/or who are not responding adequately. Individualization is the key in terms of management.

Dr. Hadley: There is a clear need for the identification of and appropriate care of patients who need further management. As clinicians, we glean from patients’ history when they have symptoms and when we can appropriately add to the pharmacological management other therapies that would be beneficial in helping patients control their environment a little bit better during specific times of the year. Some patients do need additional treatment at certain times of the year. For example, whereas patients with intermittent symptoms only need to be treated for a short period of time each year, other patients are plagued with year-round symptoms. So we have to gauge those patients appropriately.

Dr. Stoloff: Another point is that at times comanagement with an allergist or otolaryngologist will be beneficial to the patient. But the primary care physician has to recognize that and it takes time to have that discussion. Unfortunately, because allergic rhinitis is often trivialized (from a health care provider’s point of view), physicians do not step back to see how much of a burden this disease is for that individual. This lessens the opportunity to gain effective consultation in the specific fields, and therefore lessens the opportunity for better health for the patient.

How do current guidelines influence your current treatment practice? Which guidelines are useful?

Dr. Meltzer: The ARIA guidelines originate from a WHO program, initiated in 1999, to create an international appreciation of the morbidity associated with allergic rhinitis. They borrowed from the NIH guidelines for asthma, the classification concept of intermittent and persistent and rating of the disease into mild, moderate, and severe categories. I think that this is clinically more relevant than the FDA classifications of seasonal and perennial allergic rhinitis. If a person suffers symptoms when they visit a family member with cats for 2 weeks over Christmas—then that’s an intermittent problem. It is not really a “perennial” problem in terms of the allergen. The FDA view may be appropriate for approval of medications, but from the management standpoint of patients, classifications of persistent, intermittent and mild, moderate or severe are much more useful. Indeed US guidelines now also use these classifications.

The name ARIA actually stands for Allergic Rhinitis Impact on Asthma, and the impact on asthma was a key driver for the WHO program. ARIA recognized the concept of the unified airway and the consequence that having inflammation in one area of the airway created for other parts of the airway. The guidelines highlighted the recommendation to evaluate patients with allergic rhinitis for lower airway disease (be it with a pulmonary function or at least a good history), and conversely for patients with lower airway disease to check for an upper airway history of problems as well. This is important because there is crosstalk, and we should be managing the whole airway—reducing inflammation in all of it.

Dr. Stoloff: From my viewpoint, very few of my peers are aware of ARIA and what it recommends. Similarly, many of them are not aware of the differences between the FDA classification and clinical guidelines. They simply do not know that the field is moving away from using seasonal and perennial terminology and towards a redefinition in terms of severity, frequency, and intensity.

Dr. Hadley: I agree that the awareness of the ARIA guidelines in general medical communities is low. We should point outthat the American Academy of Asthma, Allergy & Immunology (AAAAI) did publish practice parameters for rhinitis in 2008 and those have made a lot of sense as they give a practitioner a stepwise process to look at whether the symptoms are intermittent versus persistent, the degree of severity, and then makes recommendations on the types of medication that can be of clinical benefit to the patient. These guidelines are much more useful to the primary care physician.

Dr. Stoloff: Speaking as an author of both the ARIA and the AAAAI practice parameters, one of the major problems is that my colleagues in primary care do not routinely read the journals where the guidelines are published. Thus, the information is not disseminated and consequently not incorporated into their clinical practice. If presented and disseminated properly, guidelines should influence the way clinicians look at these health care issues, for the patient’s benefit, for cost benefit, and for improving their practice, gaining better out come for everyone.

Dr. Meltzer: I think there are some common concepts that have been incorporated into each of the guidelines discussed. Firstly, we need to classify people by severity. Secondly, we need to appreciate that people with upper airway disease (including allergic rhinitis), often have involvement of other areas of the respiratory tract. In other words we need to consider the comorbidities of the associated diseases. Thirdly, once we appreciate the magnitude of the problems, the patient together with the clinician needs to establish goals. Fourthly, there are step recommendations; if the symptoms are mild or intermittent, less management is needed. If the symptoms are moderate to severe, and/or persistent, more intensive management is required. There are also defined therapeutic steps as to when one might include immunotherapy as part of the regimen. Finally, patients should be monitored as part of the long-term management of this chronic condition.

The ultimate goal is control—control based on what the patient’s goals were when defined during their discussions with their clinician. If we incorporate those basic five concepts into our clinical practice—it will be good for the upper airway, good for the lower airway, and good for long-term health.

Given the range of products available at present for allergic rhinitis, what criteria influence your choice of product?

Dr. Hadley: The problem is that our patients have problems that they do not consider allergic rhinitis as serious, compared to conditions such as hypertension or diabetes. However, they still have a problem that significantly influences their life. As far as the range of products, many of them have already been on an oral antihistamine and many have used and abused decongestant therapy, which is over-the-counter or now behind-the-counter that they have to ask for. Patients often try to first alleviate their symptoms with some of these products, and by the time the come to see me as a specialist they have already usually started on something already, and I have to look and determine whether or not they would be acceptable to use a more advanced product.

The topical nasal steroid is the pure anti-inflammatory product. We use this to treat the inflammatory state of the patient, recognizing that allergic rhinitis is an inflammatory problem. Antihistamines can reduce some of the symptoms but not as effectively as some of the topical nasal steroids. Added to that patients obviously have a preference to use a single product that they can use once per day, for most Americans this would ideally mean taking a pill, but unfortunately that’s not the best product for them. Our challenge is to change their attitudes and beliefs about appropriate treatment of these problems.

Dr. Meltzer: As an allergist I tend to think about allergic disease not only in terms of what is, but how did it get there. It is important to understand allergic rhinitis as an inflammatory process that involves numerous mediators, cytokines, and inflammatory cells. Oral antihistamines block only one of the mediators; they have no effect on cytokines or inflammatory cells or any of the other mediators. As such, while they can help with itchy noses, sneezing and runny noses, they do not help with congestion— which is the most bothersome and the most frequent symptom. Likewise, anticholinergics only help with runny nose, and are not effective against nasal itch, sneeze or congestion. Most people with allergic rhinitis have chronic disease, and topical decongestants should not be used for prolonged periods of time. Oral decongestants have dose-related side effects and the doses required to effectively reduce congestion increase the risks of irritability, diffculty sleeping and nervousness. Leukotriene modifiers are at best minimal to modest improvers of symptoms. Thus, the intranasal corticosteroids (because of their broad based mechanisms of action) are currently considered to be the best monotherapies.

However, when prescribing intranasal corticosteroids, there are a number of important considerations. First, we should ensure the patient is administering the spray properly in terms of the technique. In addition, there may be some patient preference in terms of whether an individual prefers an aerosol formulation or an aqueous formulation. There may also be issues in regard to cost and related to the availability of different agents on a formulary. Indeed, managed care limitations have been problematic for many of us who take care of patients. Furthermore, we certainly need to monitor that patients adhere to their regimen. I find in my practice that most people do not start taking their medication prior to a season; they wait until they’re in the midst of the worst time of their symptomatology and then expect an immediate treatment effect. I try to explain to them, that allergic rhinitis is an ongoing process, a fire, and if effective therapy is established and maintained early on, then the fire can be kept under control and the outcome will be far better than trying to deal with it when there is a flare-up of the major symptoms. This is a communication issue. Every person may have a different view and we need to come to an understanding of each individuals’ viewpoint (what their goals of treatment are). We are not going to be able to force a patient to stick with a particular treatment. It’s about educating them and encouraging them to take responsibility. I tell them “when you leave my office, you’re the one who has allergic rhinitis and I recommend you take the medication. However, you make the decisions.”

Dr. Hadley: We also must not forget that inappropriate patient comprehension and knowledge can also be problematic. Some patients take their medication too late, or perhaps too long, and they have side effects. Side effects can increase the burden of their disease and impact on their ability to perform well at work or school or play.

Dr. Stoloff: Yes, in primary care, especially when treating the older population who have hypertension, one often sees patients take decongestants, and one realizes the multitude of side effects associated with them. And, as Dr. Hadley says, very few patients are aware that their medications are causing these problems.

There are basically three key aspects related to patient communication. Firstly, patient education; we need to ensure our patients are aware of what they have, why they have it and what they can do about it. Secondly, there needs to be ongoing communication between the patient and the clinician to ensure availability of questions and availability of goal setting. Thirdly, patients should have realistic expectations, because when patients revisit we can assess if we have met their expectations or if adjustments in management are needed.

Dr. Hadley: I agree. Better awareness of the disease burden will improve the patient-clinician discussion and thereby improve the patient-physician relationship. This will enable physicians to better guide their patients through proposed treatment plans.

Another important topic is patient preference. We have discussed that most patients would like a pill that has no side effects or that they can take once a day, perhaps once a week, or a patch that they don’t have to deal with. Unfortunately, we need to recognize that such a medication does not yet exist. Patients who have a problem with the inflammatory process should be seen by the clinician and steered toward the most effective medication, and I personally believe that the topical nasal steroids are the best choice to reduce the inflammatory process as much as possible. There are new aerosol formulations of topical nasal steroids that will bring more treatment options for allergic rhinitis.

Dr. Meltzer: We should also note that these new developments with regards to new delivery systems address expanding patient choice. There are also a number of combination agents and biologics in development that may also improve pharmacotherapeutic outcomes. Advances in immunotherapy will also help treat the basic cause of allergic disease. I think many of these options will become available within the next few years.

Dr. Stoloff: I concur. The other point that we have made, and I think it’s important to reiterate, allergic rhinitis is not in a silo. It is associated with, for most of the population, comorbid diseases. When clinicians look for comorbidities, they often gain a far better appreciation of the value of treating the allergic rhinitis and therefore improving their outcome for other health issues such as asthma. But this needs to be taken in the context of communicating with the patient, always taking patient needs and goals into consideration, and working within the economic health care system that we now face.

Authors of papers presented in this Supplement met in person at the 2011 Annual Meeting of the American College of Allergy, Asthma & Immunology to further discuss the clinical, social, and economic implications of the findings from the Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC. This paper represents an edited transcript of their discussion.

Given the recent changes in US health care, how should the results of the NASAL 2010 survey be used to inform current practice? What about the role of other health care professionals and what are the cost implications of the survey findings?

Dr. Hadley: Firstly, it is important to note that there were improvements in the design of the NASAL 2010 survey compared to its 2006 predecessor. More importantly, although some of the 2010 information was a little bit different, we found that the majority of patients still suffer from their symptoms, and that the symptoms are predominant and bothersome. Allergic rhinitis bothers their sleep; it bothers their work and daily activities. In other words, we have not really seen any difference in achieving a reduction of the patients’ symptoms from 2006 to 2010.

Dr. Meltzer: Looking at this issue more globally, I think that the lack of change has a great deal to do with the public not understanding what “health” is. The World Health Organization (WHO) definition of health is there should be no problems with physical, social, emotional, or mental well-being. Individuals often do not appreciate how healthy they could be, and thus do not have a reference point. The NASAL survey clearly shows that most nasal allergy sufferers are not aware of an appropriate respiratory health goal and, further, they are not cognizant of the magnitude of their disease due to their allergic rhinitis. I believe the patients are not the only ones who are unaware; I think many clinicians are also not aware of the extent of their patients’ morbidity. A current problem is that there is not enough assumption of responsibility; patients are not taking enough responsibility for their health, clinicians are not adequately managing these patients, and—despite the suggested health care reforms—there does not appear to be in the foreseeable future a system that is going to alter these conditions.

Dr. Stoloff: For example, many family physicians only ask the question “How are you (with respect to this topic)?” and patients often say they are fine, and that’s the end of the dialogue. But consequences of this type of discussion are that costs of health care continue due to the lack of health. So the person misses work or the person’s job performance is less than it would be because they don’t recognize what their health could be if they were properly treated. As far as they’re concerned, this situation has been going on year after year, and it is only when they are really bad that they know they should be somewhat better. Even then, most people do not fully appreciate what is achievable because no one in the health care system has ever told them, “You should be able to sleep through the night and wake up feeling well. You should be able to go to work. You should be able to participate in athletic, recreational venues to be healthy.” No one has brought that up, and as long as this situation continues, the cost for the patient, his or her family, and health care will continue to increase.

Dr. Hadley: One of the things that I see as an otolaryngologist is that there is also often a missed diagnosis. Everybody who comes in to see me tells me: “Doctor, I have ‘sinus’.” I think most of them are simply unaware of that fact that their nasal congestion plays a role in developing their sinus symptoms. So there is general unawareness of the importance of treating nasal allergies in the lay public, as well as in primary care physicians who have to deal with these patients. Going to issues of cost, I think that patients are seeing the economy go down, and this means that they don’t want to spend a lot of money on their health care. They have a lot of other worries, and I think this is playing a role in how we have to deal with our patients.

Dr. Stoloff: People need to understand that the cost of not spending money to be healthy has a consequence that is sometimes the greater cost of being unhealthy—cost in terms of morbidity, cost in terms of missed days from work, absenteeism, presenteeism, poor ability to function in the usual domains of physical, social, emotional, and mental.

Dr. Hadley: That’s what the public just does not understand. We have not achieved the goal of informing the lay public and practitioners about how effective management can get these patients better, reduce their costs, and enable patients to go back to work and their activities.

What should be done to better act on the challenges highlighted by these important surveys? Is there a need to increase the awareness of allergic rhinitis among health care providers?

Dr. Meltzer: If we’re not making progress then we have to make some changes. It seems to me that education could drive change. The public needs to better understand that it is not insignificant to have an inflammatory process called allergic rhinitis. Allergic rhinitis is clearly underestimated in terms of its burden. It is too often unrecognized or ignored as an inconsequential problem. It is important that the person who has allergic rhinitis does not disregard the burden of disease. The NASAL survey reports that allergic rhinitis affects the ability to sleep well in 40 of patients. We know that allergic rhinitis also compromises people’s activities and we know that they are not as productive when they’re at work. We also know there are many comorbidities—asthma in particular, and sinusitis, otitis, conjunctivitis are other common associated conditions. Patients and clinicians need to be educated to appreciate the significant morbidity associated with allergic rhinitis, and that nasal allergies need attention and effective control.

Dr. Hadley: One of the things that we all see is patients not always getting important information about the medications that they take; there is a walk-in to the grocery store and the pharmacy shelves are filled with medications that are over-the-counter. The problem is there is not enough education about what the benefits are and what the side effects are of all those medications. There is also a lot of direct to consumer advertising—radio, television, etc., that also leads to misconceptions about the benefits of some of these medications. Patients are somewhat aware that they have a problem, but they just don’t know where to go. From the health care provider perspective, the emphasis is on treating the major problems—diabetes, hypertension—and rhinitis is considered a minor problem. So I don’t think we are educating our patients well enough. And I think that is a misconception and misunderstanding, which should be corrected.

Dr. Stoloff: Most physicians will see on their schedule a brief description of what problems their upcoming patients have. In primary care, the person filling the schedule will often say that the patient with nasal symptoms has sinusitis, which overwhelmingly it is not. That is an “easy” quick visit and the typical conversation is “Here, take this pill—if you’ve tried that pill, then take this nasal inhaler—and if you didn’t like this one I’ve got another sample for you. And then we’ll figure out which one is going to be on your list, what is covered by your insurance, and what’s the generic.” There is very little discussion about the type of impairment suffered and the overall burden on the individual. Importantly, that burden is often substantial, especially if nasal allergy symptoms were the primary reason for the office visit.

In primary care, people can have a multitude of other conditions, and allergic rhinitis is down at the bottom of the list. For example, the patient may be a hypertensive diabetic who also has seasonal allergic rhinitis. So by the time a family doctor gets to discuss allergic rhinitis, the office visit time is over and it is easier for the physician to just give a medication. But when the presence of allergic rhinitis has an enormous influence on the other diseases as far as activity, sleep, fatigue, depression, all the other emotional components, as well as physical components, that the survey highlighted—that really needs to be brought to the attention of both the patient and the health care provider to spend the appropriate time discussing it. Because it will influence care in everything else the person does.

How would you work up a patient who you might consider as potentially having allergic rhinitis?

Dr. Meltzer: When physicians view their schedule, a word or phrase supposedly informs them in advance of the patient’s condition. In reality, every patient is different and, moreover, patients with allergic rhinitis vary over the course of days, months and years in their symptomatology. So when I evaluate a patient for rhinitis and their chief complaint is “I’m having problems with my nose,” I first find out the full range of symptoms, and which symptom is for them the most bothersome (most often it will turn out to be congestion). Secondly, I would find out whether the symptoms are intermittent, or persistent. If they are fairly persistent, this informs me about somewhat of their severity, which is another very important consideration. Thirdly, I would try to find out what are the triggers for the symptoms such as non-allergic precipitants (eg, climate changes, tobacco smoke, and other environmental pollutants), or specific allergen triggers (eg, pets, springtime pollens). I would also ask about any comorbid conditions because if they are having more than just nasal symptoms that expands what I am going to need to address. I need to know all of those things before I make a treatment plan. If the disease is intermittent and mild or not very bothersome, then I am going to initiate a modest management plan. If their allergic rhinitis is more problematic, then I will need to educate the patient about what they have, why they have it and what to do about it. The patient and I will need to agree about our expectations of treatment. We are going to have an action plan for the short-term as well as a plan for follow-up visits to see if in fact our initial plan is successful. Again, the specifics will depend upon the individual patient.

Dr. Hadley: Many patients come in to an ENT clinic with an inappropriate initial diagnosis, predominantly with sinus disease, and some of them actually have come in with inappropriately obtained CT scans of the paranasal sinuses because they were presumed to have a chronic sinus infection. Most importantly, many of them have come in with inappropriately administered multiple different courses of antibiotics, which is of concern to me. So I agree with Dr. Meltzer in the need to understand the history of the patient’s symptoms—whether they are intermittent or persistent. I also obtain a family history, which helps me to work out whether the patient has an allergic tendency or not. I also have to look back and see what medications have been tried, what has worked (and not worked) in the past. The timing of the medications is really important, and the patient’s own perceptions about whether they want a medication that is going to be beneficial, or whether they want a simple remedy also plays a role. Also, let’s not forget what Dr. Meltzer also talked about—environmental controls that can be helpful to reduce the patient’s symptomatology as well.

Dr. Stoloff: From my perspective, I’m always impressed how a simple explanation of what allergy actually is, in terms of definition and measurement, creates a totally different dialogue with the patient. When my patients come in, they are often past the point of just administering a medicine, and trying others if it didn’t work—especially now there are so many generic over-the-counter products in oral antihistamines available. As a consequence, I really want to talk to them about what is going on— what is the family history, what is the seasonality of the components. I live at a fairly substantial altitude with little or no humidity, so some of the environmental issues that are very clear in San Diego where Dr. Meltzer practices have no role in my patients. However, some of the people I’ve seen have come in with pages of an expensive serum test that shows positive for certain items that have no influence on the patient’s current environment.

Patient history has to guide our workup. Dr. Hadley’s point about family history was important; we look to document what in fact are the causes. If we can figure out what is pushing the disease forward, maybe we can prevent some of those problems or at least lessen them. The history also helps in diagnosis. If we find by their history they’re overusing topical decongestants, that’s important. If we find they’re using their intranasal spray in the wrong way, that’s important. After obtaining the patient history, we then need to individualize our workup based on physical examination. It is important to look in the nose; if we find they have mechanical problems that’s additional information. Certainly allergic specific testing can be helpful, but it has to be targeted based on the location and based on the patient’s story.

Dr. Meltzer: We also need to target treatment. As Dr. Hadley mentioned, we need to know what has and hasn’t worked in the past and what are the contributing mechanism of the rhinitis for a given patient—is it only allergic, is it infectious, is it nonspecific irritants, is it mechanical, or is it a mixture of all of these. Pharmacologic therapy can be stepped up or stepped down depending upon the patient’s progress. And immunotherapy is certainly an appropriate choice in patients who have more severe disease and/or who are not responding adequately. Individualization is the key in terms of management.

Dr. Hadley: There is a clear need for the identification of and appropriate care of patients who need further management. As clinicians, we glean from patients’ history when they have symptoms and when we can appropriately add to the pharmacological management other therapies that would be beneficial in helping patients control their environment a little bit better during specific times of the year. Some patients do need additional treatment at certain times of the year. For example, whereas patients with intermittent symptoms only need to be treated for a short period of time each year, other patients are plagued with year-round symptoms. So we have to gauge those patients appropriately.

Dr. Stoloff: Another point is that at times comanagement with an allergist or otolaryngologist will be beneficial to the patient. But the primary care physician has to recognize that and it takes time to have that discussion. Unfortunately, because allergic rhinitis is often trivialized (from a health care provider’s point of view), physicians do not step back to see how much of a burden this disease is for that individual. This lessens the opportunity to gain effective consultation in the specific fields, and therefore lessens the opportunity for better health for the patient.

How do current guidelines influence your current treatment practice? Which guidelines are useful?

Dr. Meltzer: The ARIA guidelines originate from a WHO program, initiated in 1999, to create an international appreciation of the morbidity associated with allergic rhinitis. They borrowed from the NIH guidelines for asthma, the classification concept of intermittent and persistent and rating of the disease into mild, moderate, and severe categories. I think that this is clinically more relevant than the FDA classifications of seasonal and perennial allergic rhinitis. If a person suffers symptoms when they visit a family member with cats for 2 weeks over Christmas—then that’s an intermittent problem. It is not really a “perennial” problem in terms of the allergen. The FDA view may be appropriate for approval of medications, but from the management standpoint of patients, classifications of persistent, intermittent and mild, moderate or severe are much more useful. Indeed US guidelines now also use these classifications.

The name ARIA actually stands for Allergic Rhinitis Impact on Asthma, and the impact on asthma was a key driver for the WHO program. ARIA recognized the concept of the unified airway and the consequence that having inflammation in one area of the airway created for other parts of the airway. The guidelines highlighted the recommendation to evaluate patients with allergic rhinitis for lower airway disease (be it with a pulmonary function or at least a good history), and conversely for patients with lower airway disease to check for an upper airway history of problems as well. This is important because there is crosstalk, and we should be managing the whole airway—reducing inflammation in all of it.

Dr. Stoloff: From my viewpoint, very few of my peers are aware of ARIA and what it recommends. Similarly, many of them are not aware of the differences between the FDA classification and clinical guidelines. They simply do not know that the field is moving away from using seasonal and perennial terminology and towards a redefinition in terms of severity, frequency, and intensity.

Dr. Hadley: I agree that the awareness of the ARIA guidelines in general medical communities is low. We should point outthat the American Academy of Asthma, Allergy & Immunology (AAAAI) did publish practice parameters for rhinitis in 2008 and those have made a lot of sense as they give a practitioner a stepwise process to look at whether the symptoms are intermittent versus persistent, the degree of severity, and then makes recommendations on the types of medication that can be of clinical benefit to the patient. These guidelines are much more useful to the primary care physician.

Dr. Stoloff: Speaking as an author of both the ARIA and the AAAAI practice parameters, one of the major problems is that my colleagues in primary care do not routinely read the journals where the guidelines are published. Thus, the information is not disseminated and consequently not incorporated into their clinical practice. If presented and disseminated properly, guidelines should influence the way clinicians look at these health care issues, for the patient’s benefit, for cost benefit, and for improving their practice, gaining better out come for everyone.

Dr. Meltzer: I think there are some common concepts that have been incorporated into each of the guidelines discussed. Firstly, we need to classify people by severity. Secondly, we need to appreciate that people with upper airway disease (including allergic rhinitis), often have involvement of other areas of the respiratory tract. In other words we need to consider the comorbidities of the associated diseases. Thirdly, once we appreciate the magnitude of the problems, the patient together with the clinician needs to establish goals. Fourthly, there are step recommendations; if the symptoms are mild or intermittent, less management is needed. If the symptoms are moderate to severe, and/or persistent, more intensive management is required. There are also defined therapeutic steps as to when one might include immunotherapy as part of the regimen. Finally, patients should be monitored as part of the long-term management of this chronic condition.

The ultimate goal is control—control based on what the patient’s goals were when defined during their discussions with their clinician. If we incorporate those basic five concepts into our clinical practice—it will be good for the upper airway, good for the lower airway, and good for long-term health.

Given the range of products available at present for allergic rhinitis, what criteria influence your choice of product?

Dr. Hadley: The problem is that our patients have problems that they do not consider allergic rhinitis as serious, compared to conditions such as hypertension or diabetes. However, they still have a problem that significantly influences their life. As far as the range of products, many of them have already been on an oral antihistamine and many have used and abused decongestant therapy, which is over-the-counter or now behind-the-counter that they have to ask for. Patients often try to first alleviate their symptoms with some of these products, and by the time the come to see me as a specialist they have already usually started on something already, and I have to look and determine whether or not they would be acceptable to use a more advanced product.

The topical nasal steroid is the pure anti-inflammatory product. We use this to treat the inflammatory state of the patient, recognizing that allergic rhinitis is an inflammatory problem. Antihistamines can reduce some of the symptoms but not as effectively as some of the topical nasal steroids. Added to that patients obviously have a preference to use a single product that they can use once per day, for most Americans this would ideally mean taking a pill, but unfortunately that’s not the best product for them. Our challenge is to change their attitudes and beliefs about appropriate treatment of these problems.

Dr. Meltzer: As an allergist I tend to think about allergic disease not only in terms of what is, but how did it get there. It is important to understand allergic rhinitis as an inflammatory process that involves numerous mediators, cytokines, and inflammatory cells. Oral antihistamines block only one of the mediators; they have no effect on cytokines or inflammatory cells or any of the other mediators. As such, while they can help with itchy noses, sneezing and runny noses, they do not help with congestion— which is the most bothersome and the most frequent symptom. Likewise, anticholinergics only help with runny nose, and are not effective against nasal itch, sneeze or congestion. Most people with allergic rhinitis have chronic disease, and topical decongestants should not be used for prolonged periods of time. Oral decongestants have dose-related side effects and the doses required to effectively reduce congestion increase the risks of irritability, diffculty sleeping and nervousness. Leukotriene modifiers are at best minimal to modest improvers of symptoms. Thus, the intranasal corticosteroids (because of their broad based mechanisms of action) are currently considered to be the best monotherapies.

However, when prescribing intranasal corticosteroids, there are a number of important considerations. First, we should ensure the patient is administering the spray properly in terms of the technique. In addition, there may be some patient preference in terms of whether an individual prefers an aerosol formulation or an aqueous formulation. There may also be issues in regard to cost and related to the availability of different agents on a formulary. Indeed, managed care limitations have been problematic for many of us who take care of patients. Furthermore, we certainly need to monitor that patients adhere to their regimen. I find in my practice that most people do not start taking their medication prior to a season; they wait until they’re in the midst of the worst time of their symptomatology and then expect an immediate treatment effect. I try to explain to them, that allergic rhinitis is an ongoing process, a fire, and if effective therapy is established and maintained early on, then the fire can be kept under control and the outcome will be far better than trying to deal with it when there is a flare-up of the major symptoms. This is a communication issue. Every person may have a different view and we need to come to an understanding of each individuals’ viewpoint (what their goals of treatment are). We are not going to be able to force a patient to stick with a particular treatment. It’s about educating them and encouraging them to take responsibility. I tell them “when you leave my office, you’re the one who has allergic rhinitis and I recommend you take the medication. However, you make the decisions.”

Dr. Hadley: We also must not forget that inappropriate patient comprehension and knowledge can also be problematic. Some patients take their medication too late, or perhaps too long, and they have side effects. Side effects can increase the burden of their disease and impact on their ability to perform well at work or school or play.

Dr. Stoloff: Yes, in primary care, especially when treating the older population who have hypertension, one often sees patients take decongestants, and one realizes the multitude of side effects associated with them. And, as Dr. Hadley says, very few patients are aware that their medications are causing these problems.

There are basically three key aspects related to patient communication. Firstly, patient education; we need to ensure our patients are aware of what they have, why they have it and what they can do about it. Secondly, there needs to be ongoing communication between the patient and the clinician to ensure availability of questions and availability of goal setting. Thirdly, patients should have realistic expectations, because when patients revisit we can assess if we have met their expectations or if adjustments in management are needed.

Dr. Hadley: I agree. Better awareness of the disease burden will improve the patient-clinician discussion and thereby improve the patient-physician relationship. This will enable physicians to better guide their patients through proposed treatment plans.

Another important topic is patient preference. We have discussed that most patients would like a pill that has no side effects or that they can take once a day, perhaps once a week, or a patch that they don’t have to deal with. Unfortunately, we need to recognize that such a medication does not yet exist. Patients who have a problem with the inflammatory process should be seen by the clinician and steered toward the most effective medication, and I personally believe that the topical nasal steroids are the best choice to reduce the inflammatory process as much as possible. There are new aerosol formulations of topical nasal steroids that will bring more treatment options for allergic rhinitis.

Dr. Meltzer: We should also note that these new developments with regards to new delivery systems address expanding patient choice. There are also a number of combination agents and biologics in development that may also improve pharmacotherapeutic outcomes. Advances in immunotherapy will also help treat the basic cause of allergic disease. I think many of these options will become available within the next few years.

Dr. Stoloff: I concur. The other point that we have made, and I think it’s important to reiterate, allergic rhinitis is not in a silo. It is associated with, for most of the population, comorbid diseases. When clinicians look for comorbidities, they often gain a far better appreciation of the value of treating the allergic rhinitis and therefore improving their outcome for other health issues such as asthma. But this needs to be taken in the context of communicating with the patient, always taking patient needs and goals into consideration, and working within the economic health care system that we now face.

Authors of papers presented in this Supplement met in person at the 2011 Annual Meeting of the American College of Allergy, Asthma & Immunology to further discuss the clinical, social, and economic implications of the findings from the Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC. This paper represents an edited transcript of their discussion.

Given the recent changes in US health care, how should the results of the NASAL 2010 survey be used to inform current practice? What about the role of other health care professionals and what are the cost implications of the survey findings?

Dr. Hadley: Firstly, it is important to note that there were improvements in the design of the NASAL 2010 survey compared to its 2006 predecessor. More importantly, although some of the 2010 information was a little bit different, we found that the majority of patients still suffer from their symptoms, and that the symptoms are predominant and bothersome. Allergic rhinitis bothers their sleep; it bothers their work and daily activities. In other words, we have not really seen any difference in achieving a reduction of the patients’ symptoms from 2006 to 2010.

Dr. Meltzer: Looking at this issue more globally, I think that the lack of change has a great deal to do with the public not understanding what “health” is. The World Health Organization (WHO) definition of health is there should be no problems with physical, social, emotional, or mental well-being. Individuals often do not appreciate how healthy they could be, and thus do not have a reference point. The NASAL survey clearly shows that most nasal allergy sufferers are not aware of an appropriate respiratory health goal and, further, they are not cognizant of the magnitude of their disease due to their allergic rhinitis. I believe the patients are not the only ones who are unaware; I think many clinicians are also not aware of the extent of their patients’ morbidity. A current problem is that there is not enough assumption of responsibility; patients are not taking enough responsibility for their health, clinicians are not adequately managing these patients, and—despite the suggested health care reforms—there does not appear to be in the foreseeable future a system that is going to alter these conditions.

Dr. Stoloff: For example, many family physicians only ask the question “How are you (with respect to this topic)?” and patients often say they are fine, and that’s the end of the dialogue. But consequences of this type of discussion are that costs of health care continue due to the lack of health. So the person misses work or the person’s job performance is less than it would be because they don’t recognize what their health could be if they were properly treated. As far as they’re concerned, this situation has been going on year after year, and it is only when they are really bad that they know they should be somewhat better. Even then, most people do not fully appreciate what is achievable because no one in the health care system has ever told them, “You should be able to sleep through the night and wake up feeling well. You should be able to go to work. You should be able to participate in athletic, recreational venues to be healthy.” No one has brought that up, and as long as this situation continues, the cost for the patient, his or her family, and health care will continue to increase.

Dr. Hadley: One of the things that I see as an otolaryngologist is that there is also often a missed diagnosis. Everybody who comes in to see me tells me: “Doctor, I have ‘sinus’.” I think most of them are simply unaware of that fact that their nasal congestion plays a role in developing their sinus symptoms. So there is general unawareness of the importance of treating nasal allergies in the lay public, as well as in primary care physicians who have to deal with these patients. Going to issues of cost, I think that patients are seeing the economy go down, and this means that they don’t want to spend a lot of money on their health care. They have a lot of other worries, and I think this is playing a role in how we have to deal with our patients.

Dr. Stoloff: People need to understand that the cost of not spending money to be healthy has a consequence that is sometimes the greater cost of being unhealthy—cost in terms of morbidity, cost in terms of missed days from work, absenteeism, presenteeism, poor ability to function in the usual domains of physical, social, emotional, and mental.

Dr. Hadley: That’s what the public just does not understand. We have not achieved the goal of informing the lay public and practitioners about how effective management can get these patients better, reduce their costs, and enable patients to go back to work and their activities.

What should be done to better act on the challenges highlighted by these important surveys? Is there a need to increase the awareness of allergic rhinitis among health care providers?

Dr. Meltzer: If we’re not making progress then we have to make some changes. It seems to me that education could drive change. The public needs to better understand that it is not insignificant to have an inflammatory process called allergic rhinitis. Allergic rhinitis is clearly underestimated in terms of its burden. It is too often unrecognized or ignored as an inconsequential problem. It is important that the person who has allergic rhinitis does not disregard the burden of disease. The NASAL survey reports that allergic rhinitis affects the ability to sleep well in 40 of patients. We know that allergic rhinitis also compromises people’s activities and we know that they are not as productive when they’re at work. We also know there are many comorbidities—asthma in particular, and sinusitis, otitis, conjunctivitis are other common associated conditions. Patients and clinicians need to be educated to appreciate the significant morbidity associated with allergic rhinitis, and that nasal allergies need attention and effective control.

Dr. Hadley: One of the things that we all see is patients not always getting important information about the medications that they take; there is a walk-in to the grocery store and the pharmacy shelves are filled with medications that are over-the-counter. The problem is there is not enough education about what the benefits are and what the side effects are of all those medications. There is also a lot of direct to consumer advertising—radio, television, etc., that also leads to misconceptions about the benefits of some of these medications. Patients are somewhat aware that they have a problem, but they just don’t know where to go. From the health care provider perspective, the emphasis is on treating the major problems—diabetes, hypertension—and rhinitis is considered a minor problem. So I don’t think we are educating our patients well enough. And I think that is a misconception and misunderstanding, which should be corrected.

Dr. Stoloff: Most physicians will see on their schedule a brief description of what problems their upcoming patients have. In primary care, the person filling the schedule will often say that the patient with nasal symptoms has sinusitis, which overwhelmingly it is not. That is an “easy” quick visit and the typical conversation is “Here, take this pill—if you’ve tried that pill, then take this nasal inhaler—and if you didn’t like this one I’ve got another sample for you. And then we’ll figure out which one is going to be on your list, what is covered by your insurance, and what’s the generic.” There is very little discussion about the type of impairment suffered and the overall burden on the individual. Importantly, that burden is often substantial, especially if nasal allergy symptoms were the primary reason for the office visit.

In primary care, people can have a multitude of other conditions, and allergic rhinitis is down at the bottom of the list. For example, the patient may be a hypertensive diabetic who also has seasonal allergic rhinitis. So by the time a family doctor gets to discuss allergic rhinitis, the office visit time is over and it is easier for the physician to just give a medication. But when the presence of allergic rhinitis has an enormous influence on the other diseases as far as activity, sleep, fatigue, depression, all the other emotional components, as well as physical components, that the survey highlighted—that really needs to be brought to the attention of both the patient and the health care provider to spend the appropriate time discussing it. Because it will influence care in everything else the person does.

How would you work up a patient who you might consider as potentially having allergic rhinitis?

Dr. Meltzer: When physicians view their schedule, a word or phrase supposedly informs them in advance of the patient’s condition. In reality, every patient is different and, moreover, patients with allergic rhinitis vary over the course of days, months and years in their symptomatology. So when I evaluate a patient for rhinitis and their chief complaint is “I’m having problems with my nose,” I first find out the full range of symptoms, and which symptom is for them the most bothersome (most often it will turn out to be congestion). Secondly, I would find out whether the symptoms are intermittent, or persistent. If they are fairly persistent, this informs me about somewhat of their severity, which is another very important consideration. Thirdly, I would try to find out what are the triggers for the symptoms such as non-allergic precipitants (eg, climate changes, tobacco smoke, and other environmental pollutants), or specific allergen triggers (eg, pets, springtime pollens). I would also ask about any comorbid conditions because if they are having more than just nasal symptoms that expands what I am going to need to address. I need to know all of those things before I make a treatment plan. If the disease is intermittent and mild or not very bothersome, then I am going to initiate a modest management plan. If their allergic rhinitis is more problematic, then I will need to educate the patient about what they have, why they have it and what to do about it. The patient and I will need to agree about our expectations of treatment. We are going to have an action plan for the short-term as well as a plan for follow-up visits to see if in fact our initial plan is successful. Again, the specifics will depend upon the individual patient.

Dr. Hadley: Many patients come in to an ENT clinic with an inappropriate initial diagnosis, predominantly with sinus disease, and some of them actually have come in with inappropriately obtained CT scans of the paranasal sinuses because they were presumed to have a chronic sinus infection. Most importantly, many of them have come in with inappropriately administered multiple different courses of antibiotics, which is of concern to me. So I agree with Dr. Meltzer in the need to understand the history of the patient’s symptoms—whether they are intermittent or persistent. I also obtain a family history, which helps me to work out whether the patient has an allergic tendency or not. I also have to look back and see what medications have been tried, what has worked (and not worked) in the past. The timing of the medications is really important, and the patient’s own perceptions about whether they want a medication that is going to be beneficial, or whether they want a simple remedy also plays a role. Also, let’s not forget what Dr. Meltzer also talked about—environmental controls that can be helpful to reduce the patient’s symptomatology as well.

Dr. Stoloff: From my perspective, I’m always impressed how a simple explanation of what allergy actually is, in terms of definition and measurement, creates a totally different dialogue with the patient. When my patients come in, they are often past the point of just administering a medicine, and trying others if it didn’t work—especially now there are so many generic over-the-counter products in oral antihistamines available. As a consequence, I really want to talk to them about what is going on— what is the family history, what is the seasonality of the components. I live at a fairly substantial altitude with little or no humidity, so some of the environmental issues that are very clear in San Diego where Dr. Meltzer practices have no role in my patients. However, some of the people I’ve seen have come in with pages of an expensive serum test that shows positive for certain items that have no influence on the patient’s current environment.

Patient history has to guide our workup. Dr. Hadley’s point about family history was important; we look to document what in fact are the causes. If we can figure out what is pushing the disease forward, maybe we can prevent some of those problems or at least lessen them. The history also helps in diagnosis. If we find by their history they’re overusing topical decongestants, that’s important. If we find they’re using their intranasal spray in the wrong way, that’s important. After obtaining the patient history, we then need to individualize our workup based on physical examination. It is important to look in the nose; if we find they have mechanical problems that’s additional information. Certainly allergic specific testing can be helpful, but it has to be targeted based on the location and based on the patient’s story.

Dr. Meltzer: We also need to target treatment. As Dr. Hadley mentioned, we need to know what has and hasn’t worked in the past and what are the contributing mechanism of the rhinitis for a given patient—is it only allergic, is it infectious, is it nonspecific irritants, is it mechanical, or is it a mixture of all of these. Pharmacologic therapy can be stepped up or stepped down depending upon the patient’s progress. And immunotherapy is certainly an appropriate choice in patients who have more severe disease and/or who are not responding adequately. Individualization is the key in terms of management.

Dr. Hadley: There is a clear need for the identification of and appropriate care of patients who need further management. As clinicians, we glean from patients’ history when they have symptoms and when we can appropriately add to the pharmacological management other therapies that would be beneficial in helping patients control their environment a little bit better during specific times of the year. Some patients do need additional treatment at certain times of the year. For example, whereas patients with intermittent symptoms only need to be treated for a short period of time each year, other patients are plagued with year-round symptoms. So we have to gauge those patients appropriately.

Dr. Stoloff: Another point is that at times comanagement with an allergist or otolaryngologist will be beneficial to the patient. But the primary care physician has to recognize that and it takes time to have that discussion. Unfortunately, because allergic rhinitis is often trivialized (from a health care provider’s point of view), physicians do not step back to see how much of a burden this disease is for that individual. This lessens the opportunity to gain effective consultation in the specific fields, and therefore lessens the opportunity for better health for the patient.

How do current guidelines influence your current treatment practice? Which guidelines are useful?

Dr. Meltzer: The ARIA guidelines originate from a WHO program, initiated in 1999, to create an international appreciation of the morbidity associated with allergic rhinitis. They borrowed from the NIH guidelines for asthma, the classification concept of intermittent and persistent and rating of the disease into mild, moderate, and severe categories. I think that this is clinically more relevant than the FDA classifications of seasonal and perennial allergic rhinitis. If a person suffers symptoms when they visit a family member with cats for 2 weeks over Christmas—then that’s an intermittent problem. It is not really a “perennial” problem in terms of the allergen. The FDA view may be appropriate for approval of medications, but from the management standpoint of patients, classifications of persistent, intermittent and mild, moderate or severe are much more useful. Indeed US guidelines now also use these classifications.

The name ARIA actually stands for Allergic Rhinitis Impact on Asthma, and the impact on asthma was a key driver for the WHO program. ARIA recognized the concept of the unified airway and the consequence that having inflammation in one area of the airway created for other parts of the airway. The guidelines highlighted the recommendation to evaluate patients with allergic rhinitis for lower airway disease (be it with a pulmonary function or at least a good history), and conversely for patients with lower airway disease to check for an upper airway history of problems as well. This is important because there is crosstalk, and we should be managing the whole airway—reducing inflammation in all of it.

Dr. Stoloff: From my viewpoint, very few of my peers are aware of ARIA and what it recommends. Similarly, many of them are not aware of the differences between the FDA classification and clinical guidelines. They simply do not know that the field is moving away from using seasonal and perennial terminology and towards a redefinition in terms of severity, frequency, and intensity.

Dr. Hadley: I agree that the awareness of the ARIA guidelines in general medical communities is low. We should point outthat the American Academy of Asthma, Allergy & Immunology (AAAAI) did publish practice parameters for rhinitis in 2008 and those have made a lot of sense as they give a practitioner a stepwise process to look at whether the symptoms are intermittent versus persistent, the degree of severity, and then makes recommendations on the types of medication that can be of clinical benefit to the patient. These guidelines are much more useful to the primary care physician.

Dr. Stoloff: Speaking as an author of both the ARIA and the AAAAI practice parameters, one of the major problems is that my colleagues in primary care do not routinely read the journals where the guidelines are published. Thus, the information is not disseminated and consequently not incorporated into their clinical practice. If presented and disseminated properly, guidelines should influence the way clinicians look at these health care issues, for the patient’s benefit, for cost benefit, and for improving their practice, gaining better out come for everyone.

Dr. Meltzer: I think there are some common concepts that have been incorporated into each of the guidelines discussed. Firstly, we need to classify people by severity. Secondly, we need to appreciate that people with upper airway disease (including allergic rhinitis), often have involvement of other areas of the respiratory tract. In other words we need to consider the comorbidities of the associated diseases. Thirdly, once we appreciate the magnitude of the problems, the patient together with the clinician needs to establish goals. Fourthly, there are step recommendations; if the symptoms are mild or intermittent, less management is needed. If the symptoms are moderate to severe, and/or persistent, more intensive management is required. There are also defined therapeutic steps as to when one might include immunotherapy as part of the regimen. Finally, patients should be monitored as part of the long-term management of this chronic condition.

The ultimate goal is control—control based on what the patient’s goals were when defined during their discussions with their clinician. If we incorporate those basic five concepts into our clinical practice—it will be good for the upper airway, good for the lower airway, and good for long-term health.

Given the range of products available at present for allergic rhinitis, what criteria influence your choice of product?

Dr. Hadley: The problem is that our patients have problems that they do not consider allergic rhinitis as serious, compared to conditions such as hypertension or diabetes. However, they still have a problem that significantly influences their life. As far as the range of products, many of them have already been on an oral antihistamine and many have used and abused decongestant therapy, which is over-the-counter or now behind-the-counter that they have to ask for. Patients often try to first alleviate their symptoms with some of these products, and by the time the come to see me as a specialist they have already usually started on something already, and I have to look and determine whether or not they would be acceptable to use a more advanced product.

The topical nasal steroid is the pure anti-inflammatory product. We use this to treat the inflammatory state of the patient, recognizing that allergic rhinitis is an inflammatory problem. Antihistamines can reduce some of the symptoms but not as effectively as some of the topical nasal steroids. Added to that patients obviously have a preference to use a single product that they can use once per day, for most Americans this would ideally mean taking a pill, but unfortunately that’s not the best product for them. Our challenge is to change their attitudes and beliefs about appropriate treatment of these problems.

Dr. Meltzer: As an allergist I tend to think about allergic disease not only in terms of what is, but how did it get there. It is important to understand allergic rhinitis as an inflammatory process that involves numerous mediators, cytokines, and inflammatory cells. Oral antihistamines block only one of the mediators; they have no effect on cytokines or inflammatory cells or any of the other mediators. As such, while they can help with itchy noses, sneezing and runny noses, they do not help with congestion— which is the most bothersome and the most frequent symptom. Likewise, anticholinergics only help with runny nose, and are not effective against nasal itch, sneeze or congestion. Most people with allergic rhinitis have chronic disease, and topical decongestants should not be used for prolonged periods of time. Oral decongestants have dose-related side effects and the doses required to effectively reduce congestion increase the risks of irritability, diffculty sleeping and nervousness. Leukotriene modifiers are at best minimal to modest improvers of symptoms. Thus, the intranasal corticosteroids (because of their broad based mechanisms of action) are currently considered to be the best monotherapies.

However, when prescribing intranasal corticosteroids, there are a number of important considerations. First, we should ensure the patient is administering the spray properly in terms of the technique. In addition, there may be some patient preference in terms of whether an individual prefers an aerosol formulation or an aqueous formulation. There may also be issues in regard to cost and related to the availability of different agents on a formulary. Indeed, managed care limitations have been problematic for many of us who take care of patients. Furthermore, we certainly need to monitor that patients adhere to their regimen. I find in my practice that most people do not start taking their medication prior to a season; they wait until they’re in the midst of the worst time of their symptomatology and then expect an immediate treatment effect. I try to explain to them, that allergic rhinitis is an ongoing process, a fire, and if effective therapy is established and maintained early on, then the fire can be kept under control and the outcome will be far better than trying to deal with it when there is a flare-up of the major symptoms. This is a communication issue. Every person may have a different view and we need to come to an understanding of each individuals’ viewpoint (what their goals of treatment are). We are not going to be able to force a patient to stick with a particular treatment. It’s about educating them and encouraging them to take responsibility. I tell them “when you leave my office, you’re the one who has allergic rhinitis and I recommend you take the medication. However, you make the decisions.”

Dr. Hadley: We also must not forget that inappropriate patient comprehension and knowledge can also be problematic. Some patients take their medication too late, or perhaps too long, and they have side effects. Side effects can increase the burden of their disease and impact on their ability to perform well at work or school or play.

Dr. Stoloff: Yes, in primary care, especially when treating the older population who have hypertension, one often sees patients take decongestants, and one realizes the multitude of side effects associated with them. And, as Dr. Hadley says, very few patients are aware that their medications are causing these problems.

There are basically three key aspects related to patient communication. Firstly, patient education; we need to ensure our patients are aware of what they have, why they have it and what they can do about it. Secondly, there needs to be ongoing communication between the patient and the clinician to ensure availability of questions and availability of goal setting. Thirdly, patients should have realistic expectations, because when patients revisit we can assess if we have met their expectations or if adjustments in management are needed.

Dr. Hadley: I agree. Better awareness of the disease burden will improve the patient-clinician discussion and thereby improve the patient-physician relationship. This will enable physicians to better guide their patients through proposed treatment plans.

Another important topic is patient preference. We have discussed that most patients would like a pill that has no side effects or that they can take once a day, perhaps once a week, or a patch that they don’t have to deal with. Unfortunately, we need to recognize that such a medication does not yet exist. Patients who have a problem with the inflammatory process should be seen by the clinician and steered toward the most effective medication, and I personally believe that the topical nasal steroids are the best choice to reduce the inflammatory process as much as possible. There are new aerosol formulations of topical nasal steroids that will bring more treatment options for allergic rhinitis.

Dr. Meltzer: We should also note that these new developments with regards to new delivery systems address expanding patient choice. There are also a number of combination agents and biologics in development that may also improve pharmacotherapeutic outcomes. Advances in immunotherapy will also help treat the basic cause of allergic disease. I think many of these options will become available within the next few years.

Dr. Stoloff: I concur. The other point that we have made, and I think it’s important to reiterate, allergic rhinitis is not in a silo. It is associated with, for most of the population, comorbid diseases. When clinicians look for comorbidities, they often gain a far better appreciation of the value of treating the allergic rhinitis and therefore improving their outcome for other health issues such as asthma. But this needs to be taken in the context of communicating with the patient, always taking patient needs and goals into consideration, and working within the economic health care system that we now face.

Introduction

Allergic rhinitis (AR) is a common chronic medical condition, affecting at least 40 million people in the United States (US).¹ The overall prevalence of AR has been increasing since the early 1980s across all age, sex, and racial groups and is one of the most common chronic diseases among all age groups in the US.² AR can often be a debilitating condition, which, if untreated, can result in considerable health-related and economic consequences. For example, numerous studies have demonstrated that poorly controlled symptoms of AR contribute to decreased health-related quality of life (HRQoL), reduced sleep quality, daytime fatigue, impaired learning, impaired cognitive functioning, and decreased long-term productivity.^3,4 One study evaluating the impact of AR and asthma on HRQoL found that people with AR were more likely to report problems with social activities, difficulties with daily activities, and decreased feelings of mental well-being than people without AR.⁵ Moreover, as discussed by Hadley et al⁶ later in this supplement, the presence of AR is directly linked to exacerbations of other inflammatory airway diseases, such as asthma, chronic otitis media, and rhinosinusitis and thus has additional important health implications.

Despite the fact that the symptoms of nasal congestion, sneezing, rhinorrhea, and nasal itch can be very troublesome to the patient, many people with AR do not to seek medical advice regarding treatment, choosing instead to self-treat with home remedies and over-the-counter medications.⁷ This may be because AR is perceived by both patients and the health care community as less important than other airway diseases such as asthma. However, nasal allergies are responsible for substantially more disability than is generally realized, and it has been estimated that AR results in significant absenteeism with 3.5 million lost workdays and 2 million missed school days each year.⁸ When other factors related to presenteeism (ie, performance deficits) are included, this rises to an estimated 28 million days of restricted activity or reduced productivity because of AR annually in the US.⁹ Thus, it is evident that the general population lacks an understanding of the symptom burden of AR, its associated risks for other respiratory complications, and its ability to compromise all aspects of an individual’s QoL.

The Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC, was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current hay fever, AR, or nasal allergies (N = 400) with a national sample of adults without nasal allergies (N = 522). The objective of this aspect of the survey was to examine the impact of AR on patient-perceived health status, daily activities, and emotional status. Full details of the survey methods are provided elsewhere in this supplement.

Results of the Nasal Allergy survey Assessing limitations

Impact of Nasal Allergies on Patient-Perceived Health Status

Although the majority of people with AR reported a good overall health status (excellent 11%; very good 29%; good 34%), when compared with adults without nasal allergies it became clear that AR patients rated their overall health significantly lower. Nearly twice as many adults without nasal allergies rated their health as excellent (23%), compared with AR patients (11%), and at the other extreme, nearly twice as many AR patients rated their health as only fair/poor/ very poor (27%) compared with adults without nasal allergies (15%) (FIGURE 1).

FIGURE 1

Respondent-rated general health status: Nasal allergy vs nonallergy*

All respondents were asked: In general, would you say that your health is excellent, very good, good, fair, poor, or very poor?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergy Symptoms

The most frequent allergy symptoms may not be the most bothersome, so this national sample of adults with nasal allergies was asked how troubled they had been in the past week by 6 specific allergy symptoms (FIGURE 2). About half of these allergy sufferers reported that they had been extremely, moderately, or somewhat bothered in the past week by sneezing (50%) and nasal congestion (49%). Slightly fewer than half were at least somewhat bothered in the past week by postnasal drip (46%) and runny nose (41%) and more than a third were at least somewhat bothered by headaches (37%).

When asked how these symptoms affected their daily life during their worst allergy symptoms month, 33% reported that the condition affected their daily life either a lot or a moderate amount, 23% reported some impact, 22% said it only affected their life a little, and 21% said it did not really impact their daily life at all, even during the worst month. Thus, more than half the AR patients described their symptoms as impacting life a lot, a moderate degree, or some.

FIGURE 2

Patient-rated troublesomeness of nasal allergy symptoms in the last week

Patients with nasal allergies were asked: How troubled have you been by these symptoms during the last week? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Sleep Disturbance

NASAL was one of the first surveys to provide a specific focus on the impact of nasal allergy symptoms on sleep disturbances among AR sufferers in the US. Overall, 34% reported that they have been troubled (somewhat/moderately/extremely) by difficulty in getting to sleep, 38% reported that the have been troubled by waking up during the night, and 42% reported that they have been troubled by lack of a good night’s sleep in the past week as a result of their nasal allergy symptoms (FIGURE 3). Compared with the general population, more patients with AR reported that they had been extremely or moderately bothered by difficulty in getting to sleep (24% vs 8%), at least moderately bothered by waking up during the night (31% vs 13%), and extremely or moderately troubled by lack of a good night’s sleep (26% vs 11%) as a result of their nasal symptoms in the past week.

FIGURE 3

Patient-rated problems with sleep in the last week

Patients with nasal allergies were asked: How troubled have you been by each of these symptoms during the last week as a result of your nasal symptoms? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Activity Limitations

Activity limitation provided another measure of the burden of AR. Both patients with AR and those without nasal allergies were asked whether their health kept them from working. If their health did not keep them from working, they were asked whether they were limited in the kind or amount of work they could do because of their health. If they were not kept from working or limited in the kind or amount of work they could do, they were asked if their activities were limited in any way by their health.

As many as 1 in 5 AR patients (21%) reported that their health kept them from working, compared with 12% of adults without nasal allergies. Another 11% of AR patients said that they were limited in the kind or amount of work they could do because of their health, compared with only 4% of adults without nasal allergies. Finally, considerably fewer AR patients said that they were not limited by their health in any way, compared with those without nasal allergies (58% vs 76%, respectively) (FIGURE 4).

FIGURE 4

Impact of health on daily life: Nasal allergy vs nonallergy

All respondents were asked: (A) Does your health keep you from working? (B) Are you limited in the kind or amount of work you can do because of your health? (C) Are your activities limited in any way by your health?

Base: All respondents, N = 522. *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Productivity

Nasal allergies appear to affect a person’s productivity when symptoms are problematic. Respondents in both surveys were asked, on a scale of 0 to 100, in which 100 means 100% productivity, where they would rank their productivity on average days when they did not have an immediate health concern. Adults without nasal allergies ranked their average productivity at 88% on days without immediate health concerns, which was virtually identical to the average reported productivity at 89% for AR patients on days when they were not experiencing nasal allergy symptoms. However, these same AR patients reported that their average productivity was only 71% on days when their nasal allergies were at their worst, representing a 20% decline in productivity of adults as a result of nasal allergy symptoms (FIGURE 5).

FIGURE 5

Patient-rated impact of symptoms on work productivity

Patients with nasal allergies were asked: (A) Thinking about your productivity at work on a scale from 0 to 100, where 100 means 100% productivity, where would you rank your productivity on days when you don’t have nasal allergy symptoms? (B) Where would you rank your productivity on the same scale from 0 to 100, where 100 means 100% productivity, when your nasal allergies are at their worst?

Base: All respondents, N = 400.

Nasal Allergies and Other Activity Limitations

In order to estimate the impact of nasal allergies on specific activities for adults with AR, both samples were asked how much their health limited them in 5 activity areas. Nearly twice as many AR patients said that their health limited them in outdoor activities (44% vs 21%) and in indoor activities (20% vs 11%), compared with adults without nasal allergies. Similarly, more AR patients than adults without nasal allergies felt that their health limited them in social activities (41% vs 21%), doing well at work (22% vs 14%), and having or playing with pets (24% vs 8%) (FIGURE 6).

FIGURE 6

Impact of nasal allergies on specific activities: Nasal allergy vs nonallergy*

All respondents were asked: How much do you feel that your health limits what you can do in the following areas (doing well at work, social activities, having or playing with pets, outdoor activities, indoor activities)? Do you feel your health restricts you frequently, sometimes, rarely, or never?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Emotional Burden

Nasal allergies pose an emotional burden of disease, as well as the physical burden of disease. Patients with AR were asked how often they felt certain ways during their worst month. Overall, the majority of AR patients said that they frequently or sometimes experienced emotional problems during the worst month of symptoms: 67% said that they frequently or sometimes felt irritable, 60% said they felt miserable, 28% said they felt depressed, 25% said they felt anxious, and 15% said they felt embarrassed. Even more noteworthy, 85% reported that they frequently or sometimes felt tired during the worst month of allergy symptoms (FIGURE 7).

FIGURE 7

Patient-rated emotional burden during the worst month of symptoms

Patients with nasal allergies were asked: During the worst month of allergy symptoms, how often do you feel (depressed, irritable, tired, embarassed, miserable, or anxious)— frequently, sometimes, rarely, or never?

Base: All respondents, N = 400.

Discussion

NASAL was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current AR, nasal allergies, or hay fever with a national sample of adults without nasal allergies. The survey clearly demonstrated that nasal allergies imposed a considerable burden. Only a minority of AR patients in this study considered their health to be very good or excellent, and more than 2 in 5 patients (41%) said that their health kept them from working, limited the kind or amount of work they do, or limited them in some other way.

Furthermore, the survey showed that patients were not just troubled by the presence of their AR symptoms, but that AR had added effects on various aspects of their daily life. They were troubled by not being able to sleep well at night because of their symptoms and reported being fatigued and distracted during the day. Nasal problems, particularly nasal congestion and rhinorrhea, led to disordered nighttime breathing and sleep disturbances.^10-12 Indeed, the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines included sleep disturbances as a key factor in their definition of severity based on the impact of rhinitis on HRQoL.¹³ The widespread experience of fatigue among nasal allergy patients was certainly related to sleep disruption associated with nasal allergy symptoms. It is also possible that rhinitis-disturbed sleep contributed to the very high proportion of AR patients who, in this survey, reported feeling irritable and miserable and, in the more serious cases, has been a cause of feelings of anxiety and depression, reported by up to one-quarter of AR sufferers.

Importantly, NASAL also showed that the burden of disease of AR imposed a social and economic cost on the patient and on society through its impact on work performance. In addition to keeping some allergy sufferers from working, nearly twice as many AR patients reported that their health limited them frequently or sometimes from doing well at work compared with adults without nasal allergies and their estimated productivity dropped from an average of 89% on days when they did not have nasal symptoms to 71% on days when their nasal symptoms were at their worst. These results were in agreement with those of other studies, which reported work impairment in up to 60% of patients with seasonal AR and up to 40% of those with perennial AR.¹⁴ One large US survey published in 2006 found that 55% of employees experienced AR symptoms for an average of 52.5 days per year, was absent from work 3.6 days per year because of AR, and were unproductive in the workplace for 2.3 hours per day because of AR symptoms. The mean total productivity (absenteeism + presenteeism) losses per employee per year were higher ($593) for AR than for stress, migraine, depression, arthritis/rheumatism, anxiety disorder, respiratory infections, hypertension, diabetes, asthma, and coronary heart disease.¹⁵

Five years ago, another national survey found results similar to those of NASAL regarding the impact of AR on daily life and productivity at work.¹⁶ A key goal of surveys such as this is to raise physician and ultimately patient awareness of the significant physical, social, emotional, mental, and economic impact AR has on the US public. AR is an eminently treatable condition. Environmental controls and immunotherapy are directed toward the triggers and the pathophysiologic process.¹³ Pharmacologic treatments are generally well tolerated, and studies have long shown that effective therapy can improve sleep quality and reduce daytime fatigue,^17,18 as well as benefit work productivity¹⁹ and overall QoL.²⁰ The fact that many people with AR do not seek adequate medical advice means that clinicians may not be providing sufficient patient education and that more work on public awareness of the burden of AR is needed.

Introduction

Allergic rhinitis (AR) is a common chronic medical condition, affecting at least 40 million people in the United States (US).¹ The overall prevalence of AR has been increasing since the early 1980s across all age, sex, and racial groups and is one of the most common chronic diseases among all age groups in the US.² AR can often be a debilitating condition, which, if untreated, can result in considerable health-related and economic consequences. For example, numerous studies have demonstrated that poorly controlled symptoms of AR contribute to decreased health-related quality of life (HRQoL), reduced sleep quality, daytime fatigue, impaired learning, impaired cognitive functioning, and decreased long-term productivity.^3,4 One study evaluating the impact of AR and asthma on HRQoL found that people with AR were more likely to report problems with social activities, difficulties with daily activities, and decreased feelings of mental well-being than people without AR.⁵ Moreover, as discussed by Hadley et al⁶ later in this supplement, the presence of AR is directly linked to exacerbations of other inflammatory airway diseases, such as asthma, chronic otitis media, and rhinosinusitis and thus has additional important health implications.

Despite the fact that the symptoms of nasal congestion, sneezing, rhinorrhea, and nasal itch can be very troublesome to the patient, many people with AR do not to seek medical advice regarding treatment, choosing instead to self-treat with home remedies and over-the-counter medications.⁷ This may be because AR is perceived by both patients and the health care community as less important than other airway diseases such as asthma. However, nasal allergies are responsible for substantially more disability than is generally realized, and it has been estimated that AR results in significant absenteeism with 3.5 million lost workdays and 2 million missed school days each year.⁸ When other factors related to presenteeism (ie, performance deficits) are included, this rises to an estimated 28 million days of restricted activity or reduced productivity because of AR annually in the US.⁹ Thus, it is evident that the general population lacks an understanding of the symptom burden of AR, its associated risks for other respiratory complications, and its ability to compromise all aspects of an individual’s QoL.

The Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC, was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current hay fever, AR, or nasal allergies (N = 400) with a national sample of adults without nasal allergies (N = 522). The objective of this aspect of the survey was to examine the impact of AR on patient-perceived health status, daily activities, and emotional status. Full details of the survey methods are provided elsewhere in this supplement.

Results of the Nasal Allergy survey Assessing limitations

Impact of Nasal Allergies on Patient-Perceived Health Status

Although the majority of people with AR reported a good overall health status (excellent 11%; very good 29%; good 34%), when compared with adults without nasal allergies it became clear that AR patients rated their overall health significantly lower. Nearly twice as many adults without nasal allergies rated their health as excellent (23%), compared with AR patients (11%), and at the other extreme, nearly twice as many AR patients rated their health as only fair/poor/ very poor (27%) compared with adults without nasal allergies (15%) (FIGURE 1).

FIGURE 1

Respondent-rated general health status: Nasal allergy vs nonallergy*

All respondents were asked: In general, would you say that your health is excellent, very good, good, fair, poor, or very poor?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergy Symptoms

The most frequent allergy symptoms may not be the most bothersome, so this national sample of adults with nasal allergies was asked how troubled they had been in the past week by 6 specific allergy symptoms (FIGURE 2). About half of these allergy sufferers reported that they had been extremely, moderately, or somewhat bothered in the past week by sneezing (50%) and nasal congestion (49%). Slightly fewer than half were at least somewhat bothered in the past week by postnasal drip (46%) and runny nose (41%) and more than a third were at least somewhat bothered by headaches (37%).

When asked how these symptoms affected their daily life during their worst allergy symptoms month, 33% reported that the condition affected their daily life either a lot or a moderate amount, 23% reported some impact, 22% said it only affected their life a little, and 21% said it did not really impact their daily life at all, even during the worst month. Thus, more than half the AR patients described their symptoms as impacting life a lot, a moderate degree, or some.

FIGURE 2

Patient-rated troublesomeness of nasal allergy symptoms in the last week

Patients with nasal allergies were asked: How troubled have you been by these symptoms during the last week? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Sleep Disturbance

NASAL was one of the first surveys to provide a specific focus on the impact of nasal allergy symptoms on sleep disturbances among AR sufferers in the US. Overall, 34% reported that they have been troubled (somewhat/moderately/extremely) by difficulty in getting to sleep, 38% reported that the have been troubled by waking up during the night, and 42% reported that they have been troubled by lack of a good night’s sleep in the past week as a result of their nasal allergy symptoms (FIGURE 3). Compared with the general population, more patients with AR reported that they had been extremely or moderately bothered by difficulty in getting to sleep (24% vs 8%), at least moderately bothered by waking up during the night (31% vs 13%), and extremely or moderately troubled by lack of a good night’s sleep (26% vs 11%) as a result of their nasal symptoms in the past week.

FIGURE 3

Patient-rated problems with sleep in the last week

Patients with nasal allergies were asked: How troubled have you been by each of these symptoms during the last week as a result of your nasal symptoms? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Activity Limitations

Activity limitation provided another measure of the burden of AR. Both patients with AR and those without nasal allergies were asked whether their health kept them from working. If their health did not keep them from working, they were asked whether they were limited in the kind or amount of work they could do because of their health. If they were not kept from working or limited in the kind or amount of work they could do, they were asked if their activities were limited in any way by their health.

As many as 1 in 5 AR patients (21%) reported that their health kept them from working, compared with 12% of adults without nasal allergies. Another 11% of AR patients said that they were limited in the kind or amount of work they could do because of their health, compared with only 4% of adults without nasal allergies. Finally, considerably fewer AR patients said that they were not limited by their health in any way, compared with those without nasal allergies (58% vs 76%, respectively) (FIGURE 4).

FIGURE 4

Impact of health on daily life: Nasal allergy vs nonallergy

All respondents were asked: (A) Does your health keep you from working? (B) Are you limited in the kind or amount of work you can do because of your health? (C) Are your activities limited in any way by your health?

Base: All respondents, N = 522. *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Productivity

Nasal allergies appear to affect a person’s productivity when symptoms are problematic. Respondents in both surveys were asked, on a scale of 0 to 100, in which 100 means 100% productivity, where they would rank their productivity on average days when they did not have an immediate health concern. Adults without nasal allergies ranked their average productivity at 88% on days without immediate health concerns, which was virtually identical to the average reported productivity at 89% for AR patients on days when they were not experiencing nasal allergy symptoms. However, these same AR patients reported that their average productivity was only 71% on days when their nasal allergies were at their worst, representing a 20% decline in productivity of adults as a result of nasal allergy symptoms (FIGURE 5).

FIGURE 5

Patient-rated impact of symptoms on work productivity

Patients with nasal allergies were asked: (A) Thinking about your productivity at work on a scale from 0 to 100, where 100 means 100% productivity, where would you rank your productivity on days when you don’t have nasal allergy symptoms? (B) Where would you rank your productivity on the same scale from 0 to 100, where 100 means 100% productivity, when your nasal allergies are at their worst?

Base: All respondents, N = 400.

Nasal Allergies and Other Activity Limitations

In order to estimate the impact of nasal allergies on specific activities for adults with AR, both samples were asked how much their health limited them in 5 activity areas. Nearly twice as many AR patients said that their health limited them in outdoor activities (44% vs 21%) and in indoor activities (20% vs 11%), compared with adults without nasal allergies. Similarly, more AR patients than adults without nasal allergies felt that their health limited them in social activities (41% vs 21%), doing well at work (22% vs 14%), and having or playing with pets (24% vs 8%) (FIGURE 6).

FIGURE 6

Impact of nasal allergies on specific activities: Nasal allergy vs nonallergy*

All respondents were asked: How much do you feel that your health limits what you can do in the following areas (doing well at work, social activities, having or playing with pets, outdoor activities, indoor activities)? Do you feel your health restricts you frequently, sometimes, rarely, or never?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Emotional Burden

Nasal allergies pose an emotional burden of disease, as well as the physical burden of disease. Patients with AR were asked how often they felt certain ways during their worst month. Overall, the majority of AR patients said that they frequently or sometimes experienced emotional problems during the worst month of symptoms: 67% said that they frequently or sometimes felt irritable, 60% said they felt miserable, 28% said they felt depressed, 25% said they felt anxious, and 15% said they felt embarrassed. Even more noteworthy, 85% reported that they frequently or sometimes felt tired during the worst month of allergy symptoms (FIGURE 7).

FIGURE 7

Patient-rated emotional burden during the worst month of symptoms

Patients with nasal allergies were asked: During the worst month of allergy symptoms, how often do you feel (depressed, irritable, tired, embarassed, miserable, or anxious)— frequently, sometimes, rarely, or never?

Base: All respondents, N = 400.

Discussion

NASAL was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current AR, nasal allergies, or hay fever with a national sample of adults without nasal allergies. The survey clearly demonstrated that nasal allergies imposed a considerable burden. Only a minority of AR patients in this study considered their health to be very good or excellent, and more than 2 in 5 patients (41%) said that their health kept them from working, limited the kind or amount of work they do, or limited them in some other way.

Furthermore, the survey showed that patients were not just troubled by the presence of their AR symptoms, but that AR had added effects on various aspects of their daily life. They were troubled by not being able to sleep well at night because of their symptoms and reported being fatigued and distracted during the day. Nasal problems, particularly nasal congestion and rhinorrhea, led to disordered nighttime breathing and sleep disturbances.^10-12 Indeed, the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines included sleep disturbances as a key factor in their definition of severity based on the impact of rhinitis on HRQoL.¹³ The widespread experience of fatigue among nasal allergy patients was certainly related to sleep disruption associated with nasal allergy symptoms. It is also possible that rhinitis-disturbed sleep contributed to the very high proportion of AR patients who, in this survey, reported feeling irritable and miserable and, in the more serious cases, has been a cause of feelings of anxiety and depression, reported by up to one-quarter of AR sufferers.

Importantly, NASAL also showed that the burden of disease of AR imposed a social and economic cost on the patient and on society through its impact on work performance. In addition to keeping some allergy sufferers from working, nearly twice as many AR patients reported that their health limited them frequently or sometimes from doing well at work compared with adults without nasal allergies and their estimated productivity dropped from an average of 89% on days when they did not have nasal symptoms to 71% on days when their nasal symptoms were at their worst. These results were in agreement with those of other studies, which reported work impairment in up to 60% of patients with seasonal AR and up to 40% of those with perennial AR.¹⁴ One large US survey published in 2006 found that 55% of employees experienced AR symptoms for an average of 52.5 days per year, was absent from work 3.6 days per year because of AR, and were unproductive in the workplace for 2.3 hours per day because of AR symptoms. The mean total productivity (absenteeism + presenteeism) losses per employee per year were higher ($593) for AR than for stress, migraine, depression, arthritis/rheumatism, anxiety disorder, respiratory infections, hypertension, diabetes, asthma, and coronary heart disease.¹⁵

Five years ago, another national survey found results similar to those of NASAL regarding the impact of AR on daily life and productivity at work.¹⁶ A key goal of surveys such as this is to raise physician and ultimately patient awareness of the significant physical, social, emotional, mental, and economic impact AR has on the US public. AR is an eminently treatable condition. Environmental controls and immunotherapy are directed toward the triggers and the pathophysiologic process.¹³ Pharmacologic treatments are generally well tolerated, and studies have long shown that effective therapy can improve sleep quality and reduce daytime fatigue,^17,18 as well as benefit work productivity¹⁹ and overall QoL.²⁰ The fact that many people with AR do not seek adequate medical advice means that clinicians may not be providing sufficient patient education and that more work on public awareness of the burden of AR is needed.

Introduction

Allergic rhinitis (AR) is a common chronic medical condition, affecting at least 40 million people in the United States (US).¹ The overall prevalence of AR has been increasing since the early 1980s across all age, sex, and racial groups and is one of the most common chronic diseases among all age groups in the US.² AR can often be a debilitating condition, which, if untreated, can result in considerable health-related and economic consequences. For example, numerous studies have demonstrated that poorly controlled symptoms of AR contribute to decreased health-related quality of life (HRQoL), reduced sleep quality, daytime fatigue, impaired learning, impaired cognitive functioning, and decreased long-term productivity.^3,4 One study evaluating the impact of AR and asthma on HRQoL found that people with AR were more likely to report problems with social activities, difficulties with daily activities, and decreased feelings of mental well-being than people without AR.⁵ Moreover, as discussed by Hadley et al⁶ later in this supplement, the presence of AR is directly linked to exacerbations of other inflammatory airway diseases, such as asthma, chronic otitis media, and rhinosinusitis and thus has additional important health implications.

Despite the fact that the symptoms of nasal congestion, sneezing, rhinorrhea, and nasal itch can be very troublesome to the patient, many people with AR do not to seek medical advice regarding treatment, choosing instead to self-treat with home remedies and over-the-counter medications.⁷ This may be because AR is perceived by both patients and the health care community as less important than other airway diseases such as asthma. However, nasal allergies are responsible for substantially more disability than is generally realized, and it has been estimated that AR results in significant absenteeism with 3.5 million lost workdays and 2 million missed school days each year.⁸ When other factors related to presenteeism (ie, performance deficits) are included, this rises to an estimated 28 million days of restricted activity or reduced productivity because of AR annually in the US.⁹ Thus, it is evident that the general population lacks an understanding of the symptom burden of AR, its associated risks for other respiratory complications, and its ability to compromise all aspects of an individual’s QoL.

The Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC, was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current hay fever, AR, or nasal allergies (N = 400) with a national sample of adults without nasal allergies (N = 522). The objective of this aspect of the survey was to examine the impact of AR on patient-perceived health status, daily activities, and emotional status. Full details of the survey methods are provided elsewhere in this supplement.

Results of the Nasal Allergy survey Assessing limitations

Impact of Nasal Allergies on Patient-Perceived Health Status

Although the majority of people with AR reported a good overall health status (excellent 11%; very good 29%; good 34%), when compared with adults without nasal allergies it became clear that AR patients rated their overall health significantly lower. Nearly twice as many adults without nasal allergies rated their health as excellent (23%), compared with AR patients (11%), and at the other extreme, nearly twice as many AR patients rated their health as only fair/poor/ very poor (27%) compared with adults without nasal allergies (15%) (FIGURE 1).

FIGURE 1

Respondent-rated general health status: Nasal allergy vs nonallergy*

All respondents were asked: In general, would you say that your health is excellent, very good, good, fair, poor, or very poor?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergy Symptoms

The most frequent allergy symptoms may not be the most bothersome, so this national sample of adults with nasal allergies was asked how troubled they had been in the past week by 6 specific allergy symptoms (FIGURE 2). About half of these allergy sufferers reported that they had been extremely, moderately, or somewhat bothered in the past week by sneezing (50%) and nasal congestion (49%). Slightly fewer than half were at least somewhat bothered in the past week by postnasal drip (46%) and runny nose (41%) and more than a third were at least somewhat bothered by headaches (37%).

When asked how these symptoms affected their daily life during their worst allergy symptoms month, 33% reported that the condition affected their daily life either a lot or a moderate amount, 23% reported some impact, 22% said it only affected their life a little, and 21% said it did not really impact their daily life at all, even during the worst month. Thus, more than half the AR patients described their symptoms as impacting life a lot, a moderate degree, or some.

FIGURE 2

Patient-rated troublesomeness of nasal allergy symptoms in the last week

Patients with nasal allergies were asked: How troubled have you been by these symptoms during the last week? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Sleep Disturbance

NASAL was one of the first surveys to provide a specific focus on the impact of nasal allergy symptoms on sleep disturbances among AR sufferers in the US. Overall, 34% reported that they have been troubled (somewhat/moderately/extremely) by difficulty in getting to sleep, 38% reported that the have been troubled by waking up during the night, and 42% reported that they have been troubled by lack of a good night’s sleep in the past week as a result of their nasal allergy symptoms (FIGURE 3). Compared with the general population, more patients with AR reported that they had been extremely or moderately bothered by difficulty in getting to sleep (24% vs 8%), at least moderately bothered by waking up during the night (31% vs 13%), and extremely or moderately troubled by lack of a good night’s sleep (26% vs 11%) as a result of their nasal symptoms in the past week.

FIGURE 3

Patient-rated problems with sleep in the last week

Patients with nasal allergies were asked: How troubled have you been by each of these symptoms during the last week as a result of your nasal symptoms? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Activity Limitations

Activity limitation provided another measure of the burden of AR. Both patients with AR and those without nasal allergies were asked whether their health kept them from working. If their health did not keep them from working, they were asked whether they were limited in the kind or amount of work they could do because of their health. If they were not kept from working or limited in the kind or amount of work they could do, they were asked if their activities were limited in any way by their health.

As many as 1 in 5 AR patients (21%) reported that their health kept them from working, compared with 12% of adults without nasal allergies. Another 11% of AR patients said that they were limited in the kind or amount of work they could do because of their health, compared with only 4% of adults without nasal allergies. Finally, considerably fewer AR patients said that they were not limited by their health in any way, compared with those without nasal allergies (58% vs 76%, respectively) (FIGURE 4).

FIGURE 4

Impact of health on daily life: Nasal allergy vs nonallergy

All respondents were asked: (A) Does your health keep you from working? (B) Are you limited in the kind or amount of work you can do because of your health? (C) Are your activities limited in any way by your health?

Base: All respondents, N = 522. *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Productivity

Nasal allergies appear to affect a person’s productivity when symptoms are problematic. Respondents in both surveys were asked, on a scale of 0 to 100, in which 100 means 100% productivity, where they would rank their productivity on average days when they did not have an immediate health concern. Adults without nasal allergies ranked their average productivity at 88% on days without immediate health concerns, which was virtually identical to the average reported productivity at 89% for AR patients on days when they were not experiencing nasal allergy symptoms. However, these same AR patients reported that their average productivity was only 71% on days when their nasal allergies were at their worst, representing a 20% decline in productivity of adults as a result of nasal allergy symptoms (FIGURE 5).

FIGURE 5

Patient-rated impact of symptoms on work productivity

Patients with nasal allergies were asked: (A) Thinking about your productivity at work on a scale from 0 to 100, where 100 means 100% productivity, where would you rank your productivity on days when you don’t have nasal allergy symptoms? (B) Where would you rank your productivity on the same scale from 0 to 100, where 100 means 100% productivity, when your nasal allergies are at their worst?

Base: All respondents, N = 400.

Nasal Allergies and Other Activity Limitations

In order to estimate the impact of nasal allergies on specific activities for adults with AR, both samples were asked how much their health limited them in 5 activity areas. Nearly twice as many AR patients said that their health limited them in outdoor activities (44% vs 21%) and in indoor activities (20% vs 11%), compared with adults without nasal allergies. Similarly, more AR patients than adults without nasal allergies felt that their health limited them in social activities (41% vs 21%), doing well at work (22% vs 14%), and having or playing with pets (24% vs 8%) (FIGURE 6).

FIGURE 6

Impact of nasal allergies on specific activities: Nasal allergy vs nonallergy*

All respondents were asked: How much do you feel that your health limits what you can do in the following areas (doing well at work, social activities, having or playing with pets, outdoor activities, indoor activities)? Do you feel your health restricts you frequently, sometimes, rarely, or never?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Emotional Burden

Nasal allergies pose an emotional burden of disease, as well as the physical burden of disease. Patients with AR were asked how often they felt certain ways during their worst month. Overall, the majority of AR patients said that they frequently or sometimes experienced emotional problems during the worst month of symptoms: 67% said that they frequently or sometimes felt irritable, 60% said they felt miserable, 28% said they felt depressed, 25% said they felt anxious, and 15% said they felt embarrassed. Even more noteworthy, 85% reported that they frequently or sometimes felt tired during the worst month of allergy symptoms (FIGURE 7).

FIGURE 7

Patient-rated emotional burden during the worst month of symptoms

Patients with nasal allergies were asked: During the worst month of allergy symptoms, how often do you feel (depressed, irritable, tired, embarassed, miserable, or anxious)— frequently, sometimes, rarely, or never?

Base: All respondents, N = 400.

Discussion

NASAL was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current AR, nasal allergies, or hay fever with a national sample of adults without nasal allergies. The survey clearly demonstrated that nasal allergies imposed a considerable burden. Only a minority of AR patients in this study considered their health to be very good or excellent, and more than 2 in 5 patients (41%) said that their health kept them from working, limited the kind or amount of work they do, or limited them in some other way.

Furthermore, the survey showed that patients were not just troubled by the presence of their AR symptoms, but that AR had added effects on various aspects of their daily life. They were troubled by not being able to sleep well at night because of their symptoms and reported being fatigued and distracted during the day. Nasal problems, particularly nasal congestion and rhinorrhea, led to disordered nighttime breathing and sleep disturbances.^10-12 Indeed, the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines included sleep disturbances as a key factor in their definition of severity based on the impact of rhinitis on HRQoL.¹³ The widespread experience of fatigue among nasal allergy patients was certainly related to sleep disruption associated with nasal allergy symptoms. It is also possible that rhinitis-disturbed sleep contributed to the very high proportion of AR patients who, in this survey, reported feeling irritable and miserable and, in the more serious cases, has been a cause of feelings of anxiety and depression, reported by up to one-quarter of AR sufferers.

Importantly, NASAL also showed that the burden of disease of AR imposed a social and economic cost on the patient and on society through its impact on work performance. In addition to keeping some allergy sufferers from working, nearly twice as many AR patients reported that their health limited them frequently or sometimes from doing well at work compared with adults without nasal allergies and their estimated productivity dropped from an average of 89% on days when they did not have nasal symptoms to 71% on days when their nasal symptoms were at their worst. These results were in agreement with those of other studies, which reported work impairment in up to 60% of patients with seasonal AR and up to 40% of those with perennial AR.¹⁴ One large US survey published in 2006 found that 55% of employees experienced AR symptoms for an average of 52.5 days per year, was absent from work 3.6 days per year because of AR, and were unproductive in the workplace for 2.3 hours per day because of AR symptoms. The mean total productivity (absenteeism + presenteeism) losses per employee per year were higher ($593) for AR than for stress, migraine, depression, arthritis/rheumatism, anxiety disorder, respiratory infections, hypertension, diabetes, asthma, and coronary heart disease.¹⁵

Five years ago, another national survey found results similar to those of NASAL regarding the impact of AR on daily life and productivity at work.¹⁶ A key goal of surveys such as this is to raise physician and ultimately patient awareness of the significant physical, social, emotional, mental, and economic impact AR has on the US public. AR is an eminently treatable condition. Environmental controls and immunotherapy are directed toward the triggers and the pathophysiologic process.¹³ Pharmacologic treatments are generally well tolerated, and studies have long shown that effective therapy can improve sleep quality and reduce daytime fatigue,^17,18 as well as benefit work productivity¹⁹ and overall QoL.²⁰ The fact that many people with AR do not seek adequate medical advice means that clinicians may not be providing sufficient patient education and that more work on public awareness of the burden of AR is needed.

Introduction

Allergic rhinitis (AR) is a common chronic medical condition, affecting at least 40 million people in the United States (US).¹ The overall prevalence of AR has been increasing since the early 1980s across all age, sex, and racial groups and is one of the most common chronic diseases among all age groups in the US.² AR can often be a debilitating condition, which, if untreated, can result in considerable health-related and economic consequences. For example, numerous studies have demonstrated that poorly controlled symptoms of AR contribute to decreased health-related quality of life (HRQoL), reduced sleep quality, daytime fatigue, impaired learning, impaired cognitive functioning, and decreased long-term productivity.^3,4 One study evaluating the impact of AR and asthma on HRQoL found that people with AR were more likely to report problems with social activities, difficulties with daily activities, and decreased feelings of mental well-being than people without AR.⁵ Moreover, as discussed by Hadley et al⁶ later in this supplement, the presence of AR is directly linked to exacerbations of other inflammatory airway diseases, such as asthma, chronic otitis media, and rhinosinusitis and thus has additional important health implications.

Despite the fact that the symptoms of nasal congestion, sneezing, rhinorrhea, and nasal itch can be very troublesome to the patient, many people with AR do not to seek medical advice regarding treatment, choosing instead to self-treat with home remedies and over-the-counter medications.⁷ This may be because AR is perceived by both patients and the health care community as less important than other airway diseases such as asthma. However, nasal allergies are responsible for substantially more disability than is generally realized, and it has been estimated that AR results in significant absenteeism with 3.5 million lost workdays and 2 million missed school days each year.⁸ When other factors related to presenteeism (ie, performance deficits) are included, this rises to an estimated 28 million days of restricted activity or reduced productivity because of AR annually in the US.⁹ Thus, it is evident that the general population lacks an understanding of the symptom burden of AR, its associated risks for other respiratory complications, and its ability to compromise all aspects of an individual’s QoL.

The Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC, was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current hay fever, AR, or nasal allergies (N = 400) with a national sample of adults without nasal allergies (N = 522). The objective of this aspect of the survey was to examine the impact of AR on patient-perceived health status, daily activities, and emotional status. Full details of the survey methods are provided elsewhere in this supplement.

Results of the Nasal Allergy survey Assessing limitations

Impact of Nasal Allergies on Patient-Perceived Health Status

Although the majority of people with AR reported a good overall health status (excellent 11%; very good 29%; good 34%), when compared with adults without nasal allergies it became clear that AR patients rated their overall health significantly lower. Nearly twice as many adults without nasal allergies rated their health as excellent (23%), compared with AR patients (11%), and at the other extreme, nearly twice as many AR patients rated their health as only fair/poor/ very poor (27%) compared with adults without nasal allergies (15%) (FIGURE 1).

FIGURE 1

Respondent-rated general health status: Nasal allergy vs nonallergy*

All respondents were asked: In general, would you say that your health is excellent, very good, good, fair, poor, or very poor?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergy Symptoms

The most frequent allergy symptoms may not be the most bothersome, so this national sample of adults with nasal allergies was asked how troubled they had been in the past week by 6 specific allergy symptoms (FIGURE 2). About half of these allergy sufferers reported that they had been extremely, moderately, or somewhat bothered in the past week by sneezing (50%) and nasal congestion (49%). Slightly fewer than half were at least somewhat bothered in the past week by postnasal drip (46%) and runny nose (41%) and more than a third were at least somewhat bothered by headaches (37%).

When asked how these symptoms affected their daily life during their worst allergy symptoms month, 33% reported that the condition affected their daily life either a lot or a moderate amount, 23% reported some impact, 22% said it only affected their life a little, and 21% said it did not really impact their daily life at all, even during the worst month. Thus, more than half the AR patients described their symptoms as impacting life a lot, a moderate degree, or some.

FIGURE 2

Patient-rated troublesomeness of nasal allergy symptoms in the last week

Patients with nasal allergies were asked: How troubled have you been by these symptoms during the last week? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Sleep Disturbance

NASAL was one of the first surveys to provide a specific focus on the impact of nasal allergy symptoms on sleep disturbances among AR sufferers in the US. Overall, 34% reported that they have been troubled (somewhat/moderately/extremely) by difficulty in getting to sleep, 38% reported that the have been troubled by waking up during the night, and 42% reported that they have been troubled by lack of a good night’s sleep in the past week as a result of their nasal allergy symptoms (FIGURE 3). Compared with the general population, more patients with AR reported that they had been extremely or moderately bothered by difficulty in getting to sleep (24% vs 8%), at least moderately bothered by waking up during the night (31% vs 13%), and extremely or moderately troubled by lack of a good night’s sleep (26% vs 11%) as a result of their nasal symptoms in the past week.

FIGURE 3

Patient-rated problems with sleep in the last week

Patients with nasal allergies were asked: How troubled have you been by each of these symptoms during the last week as a result of your nasal symptoms? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Activity Limitations

Activity limitation provided another measure of the burden of AR. Both patients with AR and those without nasal allergies were asked whether their health kept them from working. If their health did not keep them from working, they were asked whether they were limited in the kind or amount of work they could do because of their health. If they were not kept from working or limited in the kind or amount of work they could do, they were asked if their activities were limited in any way by their health.

As many as 1 in 5 AR patients (21%) reported that their health kept them from working, compared with 12% of adults without nasal allergies. Another 11% of AR patients said that they were limited in the kind or amount of work they could do because of their health, compared with only 4% of adults without nasal allergies. Finally, considerably fewer AR patients said that they were not limited by their health in any way, compared with those without nasal allergies (58% vs 76%, respectively) (FIGURE 4).

FIGURE 4

Impact of health on daily life: Nasal allergy vs nonallergy

All respondents were asked: (A) Does your health keep you from working? (B) Are you limited in the kind or amount of work you can do because of your health? (C) Are your activities limited in any way by your health?

Base: All respondents, N = 522. *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Productivity

Nasal allergies appear to affect a person’s productivity when symptoms are problematic. Respondents in both surveys were asked, on a scale of 0 to 100, in which 100 means 100% productivity, where they would rank their productivity on average days when they did not have an immediate health concern. Adults without nasal allergies ranked their average productivity at 88% on days without immediate health concerns, which was virtually identical to the average reported productivity at 89% for AR patients on days when they were not experiencing nasal allergy symptoms. However, these same AR patients reported that their average productivity was only 71% on days when their nasal allergies were at their worst, representing a 20% decline in productivity of adults as a result of nasal allergy symptoms (FIGURE 5).

FIGURE 5

Patient-rated impact of symptoms on work productivity

Patients with nasal allergies were asked: (A) Thinking about your productivity at work on a scale from 0 to 100, where 100 means 100% productivity, where would you rank your productivity on days when you don’t have nasal allergy symptoms? (B) Where would you rank your productivity on the same scale from 0 to 100, where 100 means 100% productivity, when your nasal allergies are at their worst?

Base: All respondents, N = 400.

Nasal Allergies and Other Activity Limitations

In order to estimate the impact of nasal allergies on specific activities for adults with AR, both samples were asked how much their health limited them in 5 activity areas. Nearly twice as many AR patients said that their health limited them in outdoor activities (44% vs 21%) and in indoor activities (20% vs 11%), compared with adults without nasal allergies. Similarly, more AR patients than adults without nasal allergies felt that their health limited them in social activities (41% vs 21%), doing well at work (22% vs 14%), and having or playing with pets (24% vs 8%) (FIGURE 6).

FIGURE 6

Impact of nasal allergies on specific activities: Nasal allergy vs nonallergy*

All respondents were asked: How much do you feel that your health limits what you can do in the following areas (doing well at work, social activities, having or playing with pets, outdoor activities, indoor activities)? Do you feel your health restricts you frequently, sometimes, rarely, or never?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Emotional Burden

Nasal allergies pose an emotional burden of disease, as well as the physical burden of disease. Patients with AR were asked how often they felt certain ways during their worst month. Overall, the majority of AR patients said that they frequently or sometimes experienced emotional problems during the worst month of symptoms: 67% said that they frequently or sometimes felt irritable, 60% said they felt miserable, 28% said they felt depressed, 25% said they felt anxious, and 15% said they felt embarrassed. Even more noteworthy, 85% reported that they frequently or sometimes felt tired during the worst month of allergy symptoms (FIGURE 7).

FIGURE 7

Patient-rated emotional burden during the worst month of symptoms

Patients with nasal allergies were asked: During the worst month of allergy symptoms, how often do you feel (depressed, irritable, tired, embarassed, miserable, or anxious)— frequently, sometimes, rarely, or never?

Base: All respondents, N = 400.

Discussion

NASAL was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current AR, nasal allergies, or hay fever with a national sample of adults without nasal allergies. The survey clearly demonstrated that nasal allergies imposed a considerable burden. Only a minority of AR patients in this study considered their health to be very good or excellent, and more than 2 in 5 patients (41%) said that their health kept them from working, limited the kind or amount of work they do, or limited them in some other way.

Furthermore, the survey showed that patients were not just troubled by the presence of their AR symptoms, but that AR had added effects on various aspects of their daily life. They were troubled by not being able to sleep well at night because of their symptoms and reported being fatigued and distracted during the day. Nasal problems, particularly nasal congestion and rhinorrhea, led to disordered nighttime breathing and sleep disturbances.^10-12 Indeed, the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines included sleep disturbances as a key factor in their definition of severity based on the impact of rhinitis on HRQoL.¹³ The widespread experience of fatigue among nasal allergy patients was certainly related to sleep disruption associated with nasal allergy symptoms. It is also possible that rhinitis-disturbed sleep contributed to the very high proportion of AR patients who, in this survey, reported feeling irritable and miserable and, in the more serious cases, has been a cause of feelings of anxiety and depression, reported by up to one-quarter of AR sufferers.

Importantly, NASAL also showed that the burden of disease of AR imposed a social and economic cost on the patient and on society through its impact on work performance. In addition to keeping some allergy sufferers from working, nearly twice as many AR patients reported that their health limited them frequently or sometimes from doing well at work compared with adults without nasal allergies and their estimated productivity dropped from an average of 89% on days when they did not have nasal symptoms to 71% on days when their nasal symptoms were at their worst. These results were in agreement with those of other studies, which reported work impairment in up to 60% of patients with seasonal AR and up to 40% of those with perennial AR.¹⁴ One large US survey published in 2006 found that 55% of employees experienced AR symptoms for an average of 52.5 days per year, was absent from work 3.6 days per year because of AR, and were unproductive in the workplace for 2.3 hours per day because of AR symptoms. The mean total productivity (absenteeism + presenteeism) losses per employee per year were higher ($593) for AR than for stress, migraine, depression, arthritis/rheumatism, anxiety disorder, respiratory infections, hypertension, diabetes, asthma, and coronary heart disease.¹⁵

Five years ago, another national survey found results similar to those of NASAL regarding the impact of AR on daily life and productivity at work.¹⁶ A key goal of surveys such as this is to raise physician and ultimately patient awareness of the significant physical, social, emotional, mental, and economic impact AR has on the US public. AR is an eminently treatable condition. Environmental controls and immunotherapy are directed toward the triggers and the pathophysiologic process.¹³ Pharmacologic treatments are generally well tolerated, and studies have long shown that effective therapy can improve sleep quality and reduce daytime fatigue,^17,18 as well as benefit work productivity¹⁹ and overall QoL.²⁰ The fact that many people with AR do not seek adequate medical advice means that clinicians may not be providing sufficient patient education and that more work on public awareness of the burden of AR is needed.

Introduction

Allergic rhinitis (AR) is a common chronic medical condition, affecting at least 40 million people in the United States (US).¹ The overall prevalence of AR has been increasing since the early 1980s across all age, sex, and racial groups and is one of the most common chronic diseases among all age groups in the US.² AR can often be a debilitating condition, which, if untreated, can result in considerable health-related and economic consequences. For example, numerous studies have demonstrated that poorly controlled symptoms of AR contribute to decreased health-related quality of life (HRQoL), reduced sleep quality, daytime fatigue, impaired learning, impaired cognitive functioning, and decreased long-term productivity.^3,4 One study evaluating the impact of AR and asthma on HRQoL found that people with AR were more likely to report problems with social activities, difficulties with daily activities, and decreased feelings of mental well-being than people without AR.⁵ Moreover, as discussed by Hadley et al⁶ later in this supplement, the presence of AR is directly linked to exacerbations of other inflammatory airway diseases, such as asthma, chronic otitis media, and rhinosinusitis and thus has additional important health implications.

Despite the fact that the symptoms of nasal congestion, sneezing, rhinorrhea, and nasal itch can be very troublesome to the patient, many people with AR do not to seek medical advice regarding treatment, choosing instead to self-treat with home remedies and over-the-counter medications.⁷ This may be because AR is perceived by both patients and the health care community as less important than other airway diseases such as asthma. However, nasal allergies are responsible for substantially more disability than is generally realized, and it has been estimated that AR results in significant absenteeism with 3.5 million lost workdays and 2 million missed school days each year.⁸ When other factors related to presenteeism (ie, performance deficits) are included, this rises to an estimated 28 million days of restricted activity or reduced productivity because of AR annually in the US.⁹ Thus, it is evident that the general population lacks an understanding of the symptom burden of AR, its associated risks for other respiratory complications, and its ability to compromise all aspects of an individual’s QoL.

The Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC, was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current hay fever, AR, or nasal allergies (N = 400) with a national sample of adults without nasal allergies (N = 522). The objective of this aspect of the survey was to examine the impact of AR on patient-perceived health status, daily activities, and emotional status. Full details of the survey methods are provided elsewhere in this supplement.

Results of the Nasal Allergy survey Assessing limitations

Impact of Nasal Allergies on Patient-Perceived Health Status

Although the majority of people with AR reported a good overall health status (excellent 11%; very good 29%; good 34%), when compared with adults without nasal allergies it became clear that AR patients rated their overall health significantly lower. Nearly twice as many adults without nasal allergies rated their health as excellent (23%), compared with AR patients (11%), and at the other extreme, nearly twice as many AR patients rated their health as only fair/poor/ very poor (27%) compared with adults without nasal allergies (15%) (FIGURE 1).

FIGURE 1

Respondent-rated general health status: Nasal allergy vs nonallergy*

All respondents were asked: In general, would you say that your health is excellent, very good, good, fair, poor, or very poor?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergy Symptoms

The most frequent allergy symptoms may not be the most bothersome, so this national sample of adults with nasal allergies was asked how troubled they had been in the past week by 6 specific allergy symptoms (FIGURE 2). About half of these allergy sufferers reported that they had been extremely, moderately, or somewhat bothered in the past week by sneezing (50%) and nasal congestion (49%). Slightly fewer than half were at least somewhat bothered in the past week by postnasal drip (46%) and runny nose (41%) and more than a third were at least somewhat bothered by headaches (37%).

When asked how these symptoms affected their daily life during their worst allergy symptoms month, 33% reported that the condition affected their daily life either a lot or a moderate amount, 23% reported some impact, 22% said it only affected their life a little, and 21% said it did not really impact their daily life at all, even during the worst month. Thus, more than half the AR patients described their symptoms as impacting life a lot, a moderate degree, or some.

FIGURE 2

Patient-rated troublesomeness of nasal allergy symptoms in the last week

Patients with nasal allergies were asked: How troubled have you been by these symptoms during the last week? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Sleep Disturbance

NASAL was one of the first surveys to provide a specific focus on the impact of nasal allergy symptoms on sleep disturbances among AR sufferers in the US. Overall, 34% reported that they have been troubled (somewhat/moderately/extremely) by difficulty in getting to sleep, 38% reported that the have been troubled by waking up during the night, and 42% reported that they have been troubled by lack of a good night’s sleep in the past week as a result of their nasal allergy symptoms (FIGURE 3). Compared with the general population, more patients with AR reported that they had been extremely or moderately bothered by difficulty in getting to sleep (24% vs 8%), at least moderately bothered by waking up during the night (31% vs 13%), and extremely or moderately troubled by lack of a good night’s sleep (26% vs 11%) as a result of their nasal symptoms in the past week.

FIGURE 3

Patient-rated problems with sleep in the last week

Patients with nasal allergies were asked: How troubled have you been by each of these symptoms during the last week as a result of your nasal symptoms? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Activity Limitations

Activity limitation provided another measure of the burden of AR. Both patients with AR and those without nasal allergies were asked whether their health kept them from working. If their health did not keep them from working, they were asked whether they were limited in the kind or amount of work they could do because of their health. If they were not kept from working or limited in the kind or amount of work they could do, they were asked if their activities were limited in any way by their health.

As many as 1 in 5 AR patients (21%) reported that their health kept them from working, compared with 12% of adults without nasal allergies. Another 11% of AR patients said that they were limited in the kind or amount of work they could do because of their health, compared with only 4% of adults without nasal allergies. Finally, considerably fewer AR patients said that they were not limited by their health in any way, compared with those without nasal allergies (58% vs 76%, respectively) (FIGURE 4).

FIGURE 4

Impact of health on daily life: Nasal allergy vs nonallergy

All respondents were asked: (A) Does your health keep you from working? (B) Are you limited in the kind or amount of work you can do because of your health? (C) Are your activities limited in any way by your health?

Base: All respondents, N = 522. *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Productivity

Nasal allergies appear to affect a person’s productivity when symptoms are problematic. Respondents in both surveys were asked, on a scale of 0 to 100, in which 100 means 100% productivity, where they would rank their productivity on average days when they did not have an immediate health concern. Adults without nasal allergies ranked their average productivity at 88% on days without immediate health concerns, which was virtually identical to the average reported productivity at 89% for AR patients on days when they were not experiencing nasal allergy symptoms. However, these same AR patients reported that their average productivity was only 71% on days when their nasal allergies were at their worst, representing a 20% decline in productivity of adults as a result of nasal allergy symptoms (FIGURE 5).

FIGURE 5

Patient-rated impact of symptoms on work productivity

Patients with nasal allergies were asked: (A) Thinking about your productivity at work on a scale from 0 to 100, where 100 means 100% productivity, where would you rank your productivity on days when you don’t have nasal allergy symptoms? (B) Where would you rank your productivity on the same scale from 0 to 100, where 100 means 100% productivity, when your nasal allergies are at their worst?

Base: All respondents, N = 400.

Nasal Allergies and Other Activity Limitations

In order to estimate the impact of nasal allergies on specific activities for adults with AR, both samples were asked how much their health limited them in 5 activity areas. Nearly twice as many AR patients said that their health limited them in outdoor activities (44% vs 21%) and in indoor activities (20% vs 11%), compared with adults without nasal allergies. Similarly, more AR patients than adults without nasal allergies felt that their health limited them in social activities (41% vs 21%), doing well at work (22% vs 14%), and having or playing with pets (24% vs 8%) (FIGURE 6).

FIGURE 6

Impact of nasal allergies on specific activities: Nasal allergy vs nonallergy*

All respondents were asked: How much do you feel that your health limits what you can do in the following areas (doing well at work, social activities, having or playing with pets, outdoor activities, indoor activities)? Do you feel your health restricts you frequently, sometimes, rarely, or never?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Emotional Burden

Nasal allergies pose an emotional burden of disease, as well as the physical burden of disease. Patients with AR were asked how often they felt certain ways during their worst month. Overall, the majority of AR patients said that they frequently or sometimes experienced emotional problems during the worst month of symptoms: 67% said that they frequently or sometimes felt irritable, 60% said they felt miserable, 28% said they felt depressed, 25% said they felt anxious, and 15% said they felt embarrassed. Even more noteworthy, 85% reported that they frequently or sometimes felt tired during the worst month of allergy symptoms (FIGURE 7).

FIGURE 7

Patient-rated emotional burden during the worst month of symptoms

Patients with nasal allergies were asked: During the worst month of allergy symptoms, how often do you feel (depressed, irritable, tired, embarassed, miserable, or anxious)— frequently, sometimes, rarely, or never?

Base: All respondents, N = 400.

Discussion

NASAL was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current AR, nasal allergies, or hay fever with a national sample of adults without nasal allergies. The survey clearly demonstrated that nasal allergies imposed a considerable burden. Only a minority of AR patients in this study considered their health to be very good or excellent, and more than 2 in 5 patients (41%) said that their health kept them from working, limited the kind or amount of work they do, or limited them in some other way.

Furthermore, the survey showed that patients were not just troubled by the presence of their AR symptoms, but that AR had added effects on various aspects of their daily life. They were troubled by not being able to sleep well at night because of their symptoms and reported being fatigued and distracted during the day. Nasal problems, particularly nasal congestion and rhinorrhea, led to disordered nighttime breathing and sleep disturbances.^10-12 Indeed, the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines included sleep disturbances as a key factor in their definition of severity based on the impact of rhinitis on HRQoL.¹³ The widespread experience of fatigue among nasal allergy patients was certainly related to sleep disruption associated with nasal allergy symptoms. It is also possible that rhinitis-disturbed sleep contributed to the very high proportion of AR patients who, in this survey, reported feeling irritable and miserable and, in the more serious cases, has been a cause of feelings of anxiety and depression, reported by up to one-quarter of AR sufferers.

Importantly, NASAL also showed that the burden of disease of AR imposed a social and economic cost on the patient and on society through its impact on work performance. In addition to keeping some allergy sufferers from working, nearly twice as many AR patients reported that their health limited them frequently or sometimes from doing well at work compared with adults without nasal allergies and their estimated productivity dropped from an average of 89% on days when they did not have nasal symptoms to 71% on days when their nasal symptoms were at their worst. These results were in agreement with those of other studies, which reported work impairment in up to 60% of patients with seasonal AR and up to 40% of those with perennial AR.¹⁴ One large US survey published in 2006 found that 55% of employees experienced AR symptoms for an average of 52.5 days per year, was absent from work 3.6 days per year because of AR, and were unproductive in the workplace for 2.3 hours per day because of AR symptoms. The mean total productivity (absenteeism + presenteeism) losses per employee per year were higher ($593) for AR than for stress, migraine, depression, arthritis/rheumatism, anxiety disorder, respiratory infections, hypertension, diabetes, asthma, and coronary heart disease.¹⁵

Five years ago, another national survey found results similar to those of NASAL regarding the impact of AR on daily life and productivity at work.¹⁶ A key goal of surveys such as this is to raise physician and ultimately patient awareness of the significant physical, social, emotional, mental, and economic impact AR has on the US public. AR is an eminently treatable condition. Environmental controls and immunotherapy are directed toward the triggers and the pathophysiologic process.¹³ Pharmacologic treatments are generally well tolerated, and studies have long shown that effective therapy can improve sleep quality and reduce daytime fatigue,^17,18 as well as benefit work productivity¹⁹ and overall QoL.²⁰ The fact that many people with AR do not seek adequate medical advice means that clinicians may not be providing sufficient patient education and that more work on public awareness of the burden of AR is needed.

Introduction

Allergic rhinitis (AR) is a common chronic medical condition, affecting at least 40 million people in the United States (US).¹ The overall prevalence of AR has been increasing since the early 1980s across all age, sex, and racial groups and is one of the most common chronic diseases among all age groups in the US.² AR can often be a debilitating condition, which, if untreated, can result in considerable health-related and economic consequences. For example, numerous studies have demonstrated that poorly controlled symptoms of AR contribute to decreased health-related quality of life (HRQoL), reduced sleep quality, daytime fatigue, impaired learning, impaired cognitive functioning, and decreased long-term productivity.^3,4 One study evaluating the impact of AR and asthma on HRQoL found that people with AR were more likely to report problems with social activities, difficulties with daily activities, and decreased feelings of mental well-being than people without AR.⁵ Moreover, as discussed by Hadley et al⁶ later in this supplement, the presence of AR is directly linked to exacerbations of other inflammatory airway diseases, such as asthma, chronic otitis media, and rhinosinusitis and thus has additional important health implications.

Despite the fact that the symptoms of nasal congestion, sneezing, rhinorrhea, and nasal itch can be very troublesome to the patient, many people with AR do not to seek medical advice regarding treatment, choosing instead to self-treat with home remedies and over-the-counter medications.⁷ This may be because AR is perceived by both patients and the health care community as less important than other airway diseases such as asthma. However, nasal allergies are responsible for substantially more disability than is generally realized, and it has been estimated that AR results in significant absenteeism with 3.5 million lost workdays and 2 million missed school days each year.⁸ When other factors related to presenteeism (ie, performance deficits) are included, this rises to an estimated 28 million days of restricted activity or reduced productivity because of AR annually in the US.⁹ Thus, it is evident that the general population lacks an understanding of the symptom burden of AR, its associated risks for other respiratory complications, and its ability to compromise all aspects of an individual’s QoL.

The Nasal Allergy Survey Assessing Limitations (NASAL; www.nasalsurvey.com), a study sponsored by Teva Respiratory, LLC, was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current hay fever, AR, or nasal allergies (N = 400) with a national sample of adults without nasal allergies (N = 522). The objective of this aspect of the survey was to examine the impact of AR on patient-perceived health status, daily activities, and emotional status. Full details of the survey methods are provided elsewhere in this supplement.

Results of the Nasal Allergy survey Assessing limitations

Impact of Nasal Allergies on Patient-Perceived Health Status

Although the majority of people with AR reported a good overall health status (excellent 11%; very good 29%; good 34%), when compared with adults without nasal allergies it became clear that AR patients rated their overall health significantly lower. Nearly twice as many adults without nasal allergies rated their health as excellent (23%), compared with AR patients (11%), and at the other extreme, nearly twice as many AR patients rated their health as only fair/poor/ very poor (27%) compared with adults without nasal allergies (15%) (FIGURE 1).

FIGURE 1

Respondent-rated general health status: Nasal allergy vs nonallergy*

All respondents were asked: In general, would you say that your health is excellent, very good, good, fair, poor, or very poor?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergy Symptoms

The most frequent allergy symptoms may not be the most bothersome, so this national sample of adults with nasal allergies was asked how troubled they had been in the past week by 6 specific allergy symptoms (FIGURE 2). About half of these allergy sufferers reported that they had been extremely, moderately, or somewhat bothered in the past week by sneezing (50%) and nasal congestion (49%). Slightly fewer than half were at least somewhat bothered in the past week by postnasal drip (46%) and runny nose (41%) and more than a third were at least somewhat bothered by headaches (37%).

When asked how these symptoms affected their daily life during their worst allergy symptoms month, 33% reported that the condition affected their daily life either a lot or a moderate amount, 23% reported some impact, 22% said it only affected their life a little, and 21% said it did not really impact their daily life at all, even during the worst month. Thus, more than half the AR patients described their symptoms as impacting life a lot, a moderate degree, or some.

FIGURE 2

Patient-rated troublesomeness of nasal allergy symptoms in the last week

Patients with nasal allergies were asked: How troubled have you been by these symptoms during the last week? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Sleep Disturbance

NASAL was one of the first surveys to provide a specific focus on the impact of nasal allergy symptoms on sleep disturbances among AR sufferers in the US. Overall, 34% reported that they have been troubled (somewhat/moderately/extremely) by difficulty in getting to sleep, 38% reported that the have been troubled by waking up during the night, and 42% reported that they have been troubled by lack of a good night’s sleep in the past week as a result of their nasal allergy symptoms (FIGURE 3). Compared with the general population, more patients with AR reported that they had been extremely or moderately bothered by difficulty in getting to sleep (24% vs 8%), at least moderately bothered by waking up during the night (31% vs 13%), and extremely or moderately troubled by lack of a good night’s sleep (26% vs 11%) as a result of their nasal symptoms in the past week.

FIGURE 3

Patient-rated problems with sleep in the last week

Patients with nasal allergies were asked: How troubled have you been by each of these symptoms during the last week as a result of your nasal symptoms? Were you not at all troubled, hardly troubled, somewhat troubled, moderately troubled, or extremely troubled?

Base: All respondents, N = 400.

Nasal Allergies and Activity Limitations

Activity limitation provided another measure of the burden of AR. Both patients with AR and those without nasal allergies were asked whether their health kept them from working. If their health did not keep them from working, they were asked whether they were limited in the kind or amount of work they could do because of their health. If they were not kept from working or limited in the kind or amount of work they could do, they were asked if their activities were limited in any way by their health.

As many as 1 in 5 AR patients (21%) reported that their health kept them from working, compared with 12% of adults without nasal allergies. Another 11% of AR patients said that they were limited in the kind or amount of work they could do because of their health, compared with only 4% of adults without nasal allergies. Finally, considerably fewer AR patients said that they were not limited by their health in any way, compared with those without nasal allergies (58% vs 76%, respectively) (FIGURE 4).

FIGURE 4

Impact of health on daily life: Nasal allergy vs nonallergy

All respondents were asked: (A) Does your health keep you from working? (B) Are you limited in the kind or amount of work you can do because of your health? (C) Are your activities limited in any way by your health?

Base: All respondents, N = 522. *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Productivity

Nasal allergies appear to affect a person’s productivity when symptoms are problematic. Respondents in both surveys were asked, on a scale of 0 to 100, in which 100 means 100% productivity, where they would rank their productivity on average days when they did not have an immediate health concern. Adults without nasal allergies ranked their average productivity at 88% on days without immediate health concerns, which was virtually identical to the average reported productivity at 89% for AR patients on days when they were not experiencing nasal allergy symptoms. However, these same AR patients reported that their average productivity was only 71% on days when their nasal allergies were at their worst, representing a 20% decline in productivity of adults as a result of nasal allergy symptoms (FIGURE 5).

FIGURE 5

Patient-rated impact of symptoms on work productivity

Patients with nasal allergies were asked: (A) Thinking about your productivity at work on a scale from 0 to 100, where 100 means 100% productivity, where would you rank your productivity on days when you don’t have nasal allergy symptoms? (B) Where would you rank your productivity on the same scale from 0 to 100, where 100 means 100% productivity, when your nasal allergies are at their worst?

Base: All respondents, N = 400.

Nasal Allergies and Other Activity Limitations

In order to estimate the impact of nasal allergies on specific activities for adults with AR, both samples were asked how much their health limited them in 5 activity areas. Nearly twice as many AR patients said that their health limited them in outdoor activities (44% vs 21%) and in indoor activities (20% vs 11%), compared with adults without nasal allergies. Similarly, more AR patients than adults without nasal allergies felt that their health limited them in social activities (41% vs 21%), doing well at work (22% vs 14%), and having or playing with pets (24% vs 8%) (FIGURE 6).

FIGURE 6

Impact of nasal allergies on specific activities: Nasal allergy vs nonallergy*

All respondents were asked: How much do you feel that your health limits what you can do in the following areas (doing well at work, social activities, having or playing with pets, outdoor activities, indoor activities)? Do you feel your health restricts you frequently, sometimes, rarely, or never?

Base: All respondents, N = 522; *Pearson chi-square, P ≤ 0.05.

Nasal Allergies and Emotional Burden

Nasal allergies pose an emotional burden of disease, as well as the physical burden of disease. Patients with AR were asked how often they felt certain ways during their worst month. Overall, the majority of AR patients said that they frequently or sometimes experienced emotional problems during the worst month of symptoms: 67% said that they frequently or sometimes felt irritable, 60% said they felt miserable, 28% said they felt depressed, 25% said they felt anxious, and 15% said they felt embarrassed. Even more noteworthy, 85% reported that they frequently or sometimes felt tired during the worst month of allergy symptoms (FIGURE 7).

FIGURE 7

Patient-rated emotional burden during the worst month of symptoms

Patients with nasal allergies were asked: During the worst month of allergy symptoms, how often do you feel (depressed, irritable, tired, embarassed, miserable, or anxious)— frequently, sometimes, rarely, or never?

Base: All respondents, N = 400.

Discussion

NASAL was the first national survey to measure the burden of disease of AR in the US by comparing the health status of adults with current AR, nasal allergies, or hay fever with a national sample of adults without nasal allergies. The survey clearly demonstrated that nasal allergies imposed a considerable burden. Only a minority of AR patients in this study considered their health to be very good or excellent, and more than 2 in 5 patients (41%) said that their health kept them from working, limited the kind or amount of work they do, or limited them in some other way.

Furthermore, the survey showed that patients were not just troubled by the presence of their AR symptoms, but that AR had added effects on various aspects of their daily life. They were troubled by not being able to sleep well at night because of their symptoms and reported being fatigued and distracted during the day. Nasal problems, particularly nasal congestion and rhinorrhea, led to disordered nighttime breathing and sleep disturbances.^10-12 Indeed, the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines included sleep disturbances as a key factor in their definition of severity based on the impact of rhinitis on HRQoL.¹³ The widespread experience of fatigue among nasal allergy patients was certainly related to sleep disruption associated with nasal allergy symptoms. It is also possible that rhinitis-disturbed sleep contributed to the very high proportion of AR patients who, in this survey, reported feeling irritable and miserable and, in the more serious cases, has been a cause of feelings of anxiety and depression, reported by up to one-quarter of AR sufferers.

Importantly, NASAL also showed that the burden of disease of AR imposed a social and economic cost on the patient and on society through its impact on work performance. In addition to keeping some allergy sufferers from working, nearly twice as many AR patients reported that their health limited them frequently or sometimes from doing well at work compared with adults without nasal allergies and their estimated productivity dropped from an average of 89% on days when they did not have nasal symptoms to 71% on days when their nasal symptoms were at their worst. These results were in agreement with those of other studies, which reported work impairment in up to 60% of patients with seasonal AR and up to 40% of those with perennial AR.¹⁴ One large US survey published in 2006 found that 55% of employees experienced AR symptoms for an average of 52.5 days per year, was absent from work 3.6 days per year because of AR, and were unproductive in the workplace for 2.3 hours per day because of AR symptoms. The mean total productivity (absenteeism + presenteeism) losses per employee per year were higher ($593) for AR than for stress, migraine, depression, arthritis/rheumatism, anxiety disorder, respiratory infections, hypertension, diabetes, asthma, and coronary heart disease.¹⁵

Five years ago, another national survey found results similar to those of NASAL regarding the impact of AR on daily life and productivity at work.¹⁶ A key goal of surveys such as this is to raise physician and ultimately patient awareness of the significant physical, social, emotional, mental, and economic impact AR has on the US public. AR is an eminently treatable condition. Environmental controls and immunotherapy are directed toward the triggers and the pathophysiologic process.¹³ Pharmacologic treatments are generally well tolerated, and studies have long shown that effective therapy can improve sleep quality and reduce daytime fatigue,^17,18 as well as benefit work productivity¹⁹ and overall QoL.²⁰ The fact that many people with AR do not seek adequate medical advice means that clinicians may not be providing sufficient patient education and that more work on public awareness of the burden of AR is needed.