An estimated 4.5% of total US health care dollars have been devoted to mitigating chronic rhinosinusitis. The most recalcitrant of these patients undergo surgery, which fails to improve symptoms in approximately 25% of patients. Recent advances in informational, microbiomic, and genomic analysis have introduced the first set of tools that patients, physicians, politicians, and payers can apply to better forecast which patients will respond favorably to endoscopic sinus surgery. This article summarizes the forces driving the application of personalized medicine to CRS and how new advances can be applied to clinical practice.
Key points
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The costs of chronic rhinosinusitis (CRS) are massive and increasing, with an estimated 4.5% of total US health care expenditures devoted to CRS care in 2011.
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Stratification of CRS by polyp status and baseline clinical history is not predictive of treatment outcomes.
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Baseline lost productivity, age, and the Sinonasal Outcome Test-22 score can effectively stratify patients into 5 distinct clusters with distinct responses to endoscopic sinus surgery.
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Genotypic data that can be discerned by an in-clinic taste test are associated with surgical outcomes in patients with CRS without nasal polyps.
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Baseline microbiomic data are associated with clinical phenotypes as well as surgical outcomes.
Introduction
Medicine as a whole is at the precipice of a revolution. The crucible of unprecedented advances in big data and financial and political pressure to provide increasingly efficient care are fueling these rapid changes. Management of CRS is particularly susceptible to these changes for various reasons. Although CRS is a devastating disease, it is not life threatening, and in the modern era, the value of treatments has to be justified. It is also a hugely expensive disease, with some estimates placing the direct costs at 4.5% of the entire health care expenditure. Given that patients with medically recalcitrant disease that undergo endoscopic sinus surgery (ESS) fail to make clinically significant improvements approximately one-fourth of the time, there will be pressure on clinicians to refine these outcomes and justify the costs.
CRS is also now recognized as a complex multifactorial disease with a poorly understood interplay between anatomy, microbiome, and innate immunity that yields the common final pathway of 2 of 4 cardinal symptoms with characteristic endoscopic and radiographic findings. New technological advances in all of these fields will help to refine outcomes, but will also require the clinician to be more facile in increasingly sophisticated technologies. Identification of patients who are good and bad surgical candidates will increasingly be demanded of the physician by patients, politicians, and payers.
This article covers the financial pressures that are driving the demand for a more efficient delivery of care, as well as the informatics and technical advances that are facilitating these refinements.
Epidemiology
A large range in prevalence of CRS is likely, due to variation of epidemiologic methods. Large questionnaire-based studies avoid the pitfalls of geographic variation and support US and European rates of CRS at approximately 10%. Confirmation of the veracity of the questionnaire-based methodology with clinical evaluations supports the accuracy of this methodology.
Understanding the true prevalence of a disease such as CRS is a critical yet challenging endeavor. Accurate prevalence estimates facilitate judicious application of research, as well as industry and health care resources in addressing CRS, and thus it behooves patients, the medical profession, and society to accurately document its prevalence. It is somewhat confusing to find that the literature on CRS reflects a wide range of prevalence, at 2% to 15%. The range of prevalence is in part driven by the underlying methodology of the epidemiologic study: large-scale questionnaire evaluations and small-scale clinical evaluations.
Questionnaire-Based Evaluations
It has been a relatively recent development that broadly accepted diagnostic criteria for CRS have been adopted. Epidemiologic studies, therefore, that predate modern definitions are limited by a lack of sensitivity and specificity and are not directly comparable. Although modern definitions of CRS require both subjective patient-reported symptoms along with physician-reported radiographic and/or endoscopic endpoints, there are practical limitations in obtaining large, population-level studies that include radiographic and endoscopic endpoints. Given these inherent limitations, a current examination of the literature places the true US prevalence of CRS at approximately 10%.
Several national surveys support this number. The US National Health Interview Survey was carried out in 2012 and is the largest of these surveys. It included 234,921 adults and 12.1% of subjects reported having been given the diagnosis of sinusitis by a health care provider in the preceding year. This likely is an overestimate of CRS rates, since the questionnaire did not clarify whether the diagnosis given was for acute or chronic disease. However, the 2008 Global Allergy and Asthma European Network questionnaire-based survey included 57,128 respondents based on the presence of at least 12 weeks of CRS patient-reported symptoms set forth in the European Position Paper on Rhinosinusitis and Nasal Polyps and found a similar prevalence of 10.9%. The Canadian analog to these surveys found a prevalence of 5.2% in 73,364 respondents. ( Table 1 ).
| Author, Year | Survey | Location | Subjects | CRS Prevalence |
|---|---|---|---|---|
| Chen et al, 2003 | NPHS | Canada | 73,364 | 5.2% |
| Hastan et al, 2011 | GA 2 LEN | Europe | 57,128 | 10.9% |
| Blackwell et al, 2014 | NHIS | United States | 234,921 | 12.10% |
Clinical Evaluations
Clinical evaluations are for the most part plagued by the inherent limitations of small sample size with a high likelihood of geographic and selection biases. However, a follow-up study of the 2008 Global Allergy and Asthma European Network survey is worth reviewing. A subset of respondents to that survey was evaluated by an otolaryngologist. Thirty-percent of the CRS diagnoses by survey were overturned; yet an additional 15% of respondents previously negative for CRS were classified as having CRS. This study helps confirm the relative veracity of the questionnaire-based approach, and suggests that not much value is added to the more expensive clinical evaluation.
Introduction
Medicine as a whole is at the precipice of a revolution. The crucible of unprecedented advances in big data and financial and political pressure to provide increasingly efficient care are fueling these rapid changes. Management of CRS is particularly susceptible to these changes for various reasons. Although CRS is a devastating disease, it is not life threatening, and in the modern era, the value of treatments has to be justified. It is also a hugely expensive disease, with some estimates placing the direct costs at 4.5% of the entire health care expenditure. Given that patients with medically recalcitrant disease that undergo endoscopic sinus surgery (ESS) fail to make clinically significant improvements approximately one-fourth of the time, there will be pressure on clinicians to refine these outcomes and justify the costs.
CRS is also now recognized as a complex multifactorial disease with a poorly understood interplay between anatomy, microbiome, and innate immunity that yields the common final pathway of 2 of 4 cardinal symptoms with characteristic endoscopic and radiographic findings. New technological advances in all of these fields will help to refine outcomes, but will also require the clinician to be more facile in increasingly sophisticated technologies. Identification of patients who are good and bad surgical candidates will increasingly be demanded of the physician by patients, politicians, and payers.
This article covers the financial pressures that are driving the demand for a more efficient delivery of care, as well as the informatics and technical advances that are facilitating these refinements.
Epidemiology
A large range in prevalence of CRS is likely, due to variation of epidemiologic methods. Large questionnaire-based studies avoid the pitfalls of geographic variation and support US and European rates of CRS at approximately 10%. Confirmation of the veracity of the questionnaire-based methodology with clinical evaluations supports the accuracy of this methodology.
Understanding the true prevalence of a disease such as CRS is a critical yet challenging endeavor. Accurate prevalence estimates facilitate judicious application of research, as well as industry and health care resources in addressing CRS, and thus it behooves patients, the medical profession, and society to accurately document its prevalence. It is somewhat confusing to find that the literature on CRS reflects a wide range of prevalence, at 2% to 15%. The range of prevalence is in part driven by the underlying methodology of the epidemiologic study: large-scale questionnaire evaluations and small-scale clinical evaluations.
Questionnaire-Based Evaluations
It has been a relatively recent development that broadly accepted diagnostic criteria for CRS have been adopted. Epidemiologic studies, therefore, that predate modern definitions are limited by a lack of sensitivity and specificity and are not directly comparable. Although modern definitions of CRS require both subjective patient-reported symptoms along with physician-reported radiographic and/or endoscopic endpoints, there are practical limitations in obtaining large, population-level studies that include radiographic and endoscopic endpoints. Given these inherent limitations, a current examination of the literature places the true US prevalence of CRS at approximately 10%.
Several national surveys support this number. The US National Health Interview Survey was carried out in 2012 and is the largest of these surveys. It included 234,921 adults and 12.1% of subjects reported having been given the diagnosis of sinusitis by a health care provider in the preceding year. This likely is an overestimate of CRS rates, since the questionnaire did not clarify whether the diagnosis given was for acute or chronic disease. However, the 2008 Global Allergy and Asthma European Network questionnaire-based survey included 57,128 respondents based on the presence of at least 12 weeks of CRS patient-reported symptoms set forth in the European Position Paper on Rhinosinusitis and Nasal Polyps and found a similar prevalence of 10.9%. The Canadian analog to these surveys found a prevalence of 5.2% in 73,364 respondents. ( Table 1 ).
| Author, Year | Survey | Location | Subjects | CRS Prevalence |
|---|---|---|---|---|
| Chen et al, 2003 | NPHS | Canada | 73,364 | 5.2% |
| Hastan et al, 2011 | GA 2 LEN | Europe | 57,128 | 10.9% |
| Blackwell et al, 2014 | NHIS | United States | 234,921 | 12.10% |
Clinical Evaluations
Clinical evaluations are for the most part plagued by the inherent limitations of small sample size with a high likelihood of geographic and selection biases. However, a follow-up study of the 2008 Global Allergy and Asthma European Network survey is worth reviewing. A subset of respondents to that survey was evaluated by an otolaryngologist. Thirty-percent of the CRS diagnoses by survey were overturned; yet an additional 15% of respondents previously negative for CRS were classified as having CRS. This study helps confirm the relative veracity of the questionnaire-based approach, and suggests that not much value is added to the more expensive clinical evaluation.
Societal burden of chronic rhinosinusitis
Medically recalcitrant CRS is a massive burden for the individual patient. In fact, patients with CRS report more impairment of quality of life than patients with Parkinson disease, coronary disease requiring percutaneous intervention, and moderate chronic obstructive pulmonary disease (COPD). The estimated direct costs of CRS are increasing, with approximately $60 billion spent in 2011, representing 4.5% of overall health care expenditure for the year. Indirect costs of medically recalcitrant CRS can be massive, with mean costs of approximately 30% of annual income in patients who elect surgical therapy.
The high prevalence of CRS and the significant quality-of-life impact of CRS suggest that it weighs heavily on society. However, determining the societal burden of any disease state is, in a way, defining the value of resolving the disease state. This process is not trivial, and has only been possible recently for CRS. The value of controlling CRS is a function of the benefit obtained in controlling the disease divided by the cost to avoid it. In the case of CRS, the costs of the disease are captured by the direct costs of therapies and the indirect costs of uncontrolled disease.
Burden to the Individual
The benefit of avoiding CRS or resolving CRS is captured by a metric known as the health utility value. The utility value of any given health state is an effort to determine the preference of that health state over any other health state. Several mechanisms exist to determine the health utility of a given disease state, but 1 mechanism includes asking subjects to estimate how much time they would be willing to sacrifice to avoid a certain poorer health sate. For example, asking a respondent to choose the number of years they would live disease-free compared with 10 years of life with CRS. Hypothetically, if the subject responded that 6.5 years of life without CRS is equivalent to 10 years with it, the utility value would be reflect the utility value of CRS, 0.65 (6.5 years divided by 10). At baseline, the mean utility value for patients with medically recalcitrant CRS was 0.65. To give this number some context, CRS ranks lower than Parkinson disease, coronary artery disease requiring percutaneous intervention, and moderate COPD. These findings were corroborated by Remenschneider and colleagues, who found a diminished, but higher utility value of 0.81, which still places CRS in line with diseases such as asthma, COPD, and angina.
Burden to Society
The purely economic burden of CRS is truly staggering and consists of both the direct and indirect costs of the disease. The direct costs to society reflect the money spent on such things as medicines, doctor visits, surgeries, and tests, and the most recent analysis estimates the annual costs at $60.2 to $64.5 billion in 2011. These estimates are in part a function of what prevalence estimate is used to extrapolate the costs. In this analysis, a conservative estimate of 3.5% was used; yet the costs represent 4.5% to 4.8% of the overall expenditures of US healthcare in 2011. The indirect costs represent the economic burden that results from decreased productivity of the population. Productivity loss is accounted for through absenteeism (missed work) and presenteeism (reduced work productivity). For an individual with medically refractory CRS (ie, uncontrolled disease), assuming mean income (in the US in 2013 approximately $31,000 annually), indirect costs result in $10,077 loss of income annually in patients who elect surgery and $3500 in patients who elect continued medical therapy. Extrapolating these losses nationwide puts indirect costs for these patients at approximately $12.8 billion in 2013 ( Table 2 ).
| Author, Year | Methodology | Direct Costs | Indirect Costs |
|---|---|---|---|
| Ray et al, 1999 | Delphi technique | $5.8 billion | — |
| Bhattacharyya, 2011 | 2007 Medical Expenditure Panel Survey | $9.8 billion | — |
| Smith et al, 2015 | Systematic review | $9.9 billion | $13 billion |
| Caulley et al, 2015 | 2011 Medical Expenditure Panel Survey | $67.8 billion | — |
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