Summary Clinical Practice Guideline Update Adult Sinusitis

572097
ryngology–Head and Neck SurgeryRosenfeld et al
2015© The Author(s) 2010

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Guideline
Otolaryngology–

Clinical Practice Guideline (Update): Head and Neck Surgery
2015, Vol. 152(2S) S1­–S39
© American Academy of
Adult Sinusitis Otolaryngology—Head and Neck
Surgery Foundation 2015
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DOI: 10.1177/0194599815572097
http://otojournal.org
Richard M. Rosenfeld, MD, MPH1, Jay F. Piccirillo, MD2,
Sujana S. Chandrasekhar, MD3, Itzhak Brook, MD, MSc4,
Kaparaboyna Ashok Kumar, MD, FRCS5, Maggie Kramper, RN, FNP6,
Richard R. Orlandi, MD7, James N. Palmer, MD8, Zara M. Patel, MD9,
Anju Peters, MD10, Sandra A. Walsh11, and Maureen D. Corrigan12

Sponsorships or competing interests that may be relevant to content are prescribe initial antibiotic therapy for adults with uncomplicated
disclosed at the end of this article. ABRS; (2) should prescribe amoxicillin with or without clavula-
nate as first-line therapy for 5 to 10 days (if a decision is made to
treat ABRS with an antibiotic); (3) should reassess the patient to
Abstract confirm ABRS, exclude other causes of illness, and detect com-
plications if the patient worsens or fails to improve with the
Objective. This update of a 2007 guideline from the Ameri- initial management option by 7 days after diagnosis or worsens
can Academy of Otolaryngology—Head and Neck Surgery during the initial management; (4) should distinguish CRS and
Foundation provides evidence-based recommendations to recurrent ARS from isolated episodes of ABRS and other
manage adult rhinosinusitis, defined as symptomatic inflam- causes of sinonasal symptoms; (5) should assess the patient
mation of the paranasal sinuses and nasal cavity. Changes from with CRS or recurrent ARS for multiple chronic conditions
the prior guideline include a consumer added to the update that would modify management, such as asthma, cystic fibrosis,
group, evidence from 42 new systematic reviews, enhanced immunocompromised state, and ciliary dyskinesia; (6) should
information on patient education and counseling, a new al- confirm the presence or absence of nasal polyps in a patient
gorithm to clarify action statement relationships, expanded with CRS; and (7) should recommend saline nasal irrigation,
opportunities for watchful waiting (without antibiotic thera- topical intranasal corticosteroids, or both for symptom relief of
py) as initial therapy of acute bacterial rhinosinusitis (ABRS), CRS. The update group stated as options that clinicians may (1)
and 3 new recommendations for managing chronic rhinosi- recommend analgesics, topical intranasal steroids, and/or nasal
nusitis (CRS). saline irrigation for symptomatic relief of viral rhinosinusitis; (2)
Purpose. The purpose of this multidisciplinary guideline is to recommend analgesics, topical intranasal steroids, and/or nasal
identify quality improvement opportunities in managing adult saline irrigation) for symptomatic relief of ABRS; and (3) obtain
rhinosinusitis and to create explicit and actionable recommen- testing for allergy and immune function in evaluating a patient
dations to implement these opportunities in clinical practice. with CRS or recurrent ARS. The update group made recom-
Specifically, the goals are to improve diagnostic accuracy for mendations that clinicians (1) should not obtain radiographic
adult rhinosinusitis, promote appropriate use of ancillary tests imaging for patients who meet diagnostic criteria for ARS, un-
to confirm diagnosis and guide management, and promote less a complication or alternative diagnosis is suspected, and (2)
judicious use of systemic and topical therapy, which includes should not prescribe topical or systemic antifungal therapy for
radiography, nasal endoscopy, computed tomography, and patients with CRS.
testing for allergy and immune function. Emphasis was also
placed on identifying multiple chronic conditions that would Keywords
modify management of rhinosinusitis, including asthma, cystic
adult sinusitis, rhinosinusitis
fibrosis, immunocompromised state, and ciliary dyskinesia.
Action statements. The update group made strong recommenda- Received November 18, 2014; revised January 6, 2014; accepted January 20,
tions that clinicians (1) should distinguish presumed ABRS from 2015.
acute rhinosinusitis (ARS) caused by viral upper respiratory
infections and noninfectious conditions and (2) should con-
firm a clinical diagnosis of CRS with objective documentation Differences from Prior Guideline
of sinonasal inflammation, which may be accomplished using This clinical practice guideline is as an update, and replace-
anterior rhinoscopy, nasal endoscopy, or computed tomogra- ment, for an earlier guideline published in 2007 by the
phy.The update group made recommendations that clinicians (1) American Academy of Otolaryngology—Head and Neck
should either offer watchful waiting (without antibiotics) or Surgery Foundation (AAO-HNS).1 An update was planned

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S2 Otolaryngology–Head and Neck Surgery 152(2S)

for 5 years after the initial publication date and was further job effectiveness, and impaired quality of life.6-8 More than 1
necessitated by new primary studies and systematic reviews in 5 antibiotics prescribed in adults are for sinusitis, making it
that might suggest a need for modifying clinically important the fifth most common diagnosis responsible for antibiotic
recommendations.2 Changes in content and methodology therapy.5 Despite the high prevalence and economic impact
from the prior guideline include the following: of sinusitis, considerable practice variations exist across
and within the multiple disciplines involved in managing the
•• Addition of a consumer advocate to the guideline condition.9,10
development group The target patient for this guideline is age 18 years or older
•• New evidence from 5 clinical practice guidelines, 42 with a clinical diagnosis of uncomplicated rhinosinusitis:
systematic reviews, and 70 randomized controlled
trials •• Rhinosinusitis is defined as symptomatic inflamma-
•• Emphasis on patient education and counseling with tion of the paranasal sinuses and nasal cavity. The
new explanatory tables term rhinosinusitis is preferred because sinusitis is
•• Expanded action statement profiles to explicitly state almost always accompanied by inflammation of the
quality improvement opportunities, confidence in the contiguous nasal mucosa.11-13 Therefore, rhinosinus-
evidence, intentional vagueness, and differences of itis is used in the remainder of the guideline.
opinion •• Uncomplicated rhinosinusitis is defined as rhino-
•• Enhanced external review process to include public sinusitis without clinically evident extension of
comment and journal peer review inflammation outside the paranasal sinuses and nasal
•• New algorithm to clarify decision-making and action cavity at the time of diagnosis (eg, no neurologic,
statement relationships ophthalmologic, or soft tissue involvement).
•• Extension of watchful waiting (without antibiotic
therapy) as an initial management strategy to all Rhinosinusitis may be classified by duration as acute rhi-
patients with uncomplicated acute bacterial rhi- nosinusitis (ARS) if less than 4 weeks’ duration or as chronic
nosinusitis (ABRS) regardless of severity, not just rhinosinusitis (CRS) if lasting more than 12 weeks, with or
patients with “mild” illness (prior guideline) without acute exacerbations. ARS may be classified further
•• Change in recommendation from first-line antibiotic by presumed etiology, based on symptoms and time course
therapy for acute bacterial rhinosinusitis amoxicillin, (Key Action Statement 1), into acute bacterial rhinosinusitis
with or without clavulanate, from amoxicillin alone (ABRS) or viral rhinosinusitis (VRS). Distinguishing pre-
(prior guideline) sumed bacterial vs viral infection is important because antibi-
•• Addition of asthma as a chronic condition that modi- otic therapy is inappropriate for the latter. When patients have
fies management of chronic rhinosinusitis (CRS) 4 or more annual episodes of rhinosinusitis, without persistent
•• Three new key action statements on managing CRS symptoms in between, the condition is termed recurrent ARS.
that focus on polyps as a modifying factor, a rec- Nearly all authorities agree that CRS begins after 12 weeks’
ommendation in favor of topical intranasal therapy duration, but opinions about the duration of ARS vary, with
(saline irrigations, corticosteroids), and a recommen- some defining illness up to 12 weeks as ARS.14 We agree with
dation against using topical or systemic antifungal other guideline groups15,16 that define ARS as up to 4 weeks’
agents duration but recognize that this boundary is based more on
consensus than research evidence. Moreover, very limited
Introduction data are available on rhinosinusitis lasting 4 to 12 weeks,
Sinusitis affects about 1 in 8 adults in the United States, result- sometimes called subacute rhinosinusitis. We do not distin-
ing in over 30 million annual diagnoses.3,4 The direct cost of guish rhinosinusitis in this time frame as an explicit entity in
managing acute and chronic sinusitis exceeds $11 billion per the guideline, and decisions about whether such patients are
year,4,5 with additional expense from lost productivity, reduced more like ARS or CRS must therefore be individualized.


1
Department of Otolaryngology, SUNY Downstate Medical Center, Brooklyn, New York, USA; 2Department of Otolaryngology–Head and Neck Surgery,
Washington University in St Louis, School of Medicine, St Louis, Missouri, USA; 3New York Otology, New York Head and Neck Institute, New York, New
York, USA; 4Department of Pediatrics, Georgetown University, Washington, DC, USA; 5Department of Family Medicine, University of Texas Health Sciences
Center at San Antonio, San Antonio, Texas, USA; 6Department of Otolaryngology, Washington University in St Louis School of Medicine, St Louis, Missouri,
USA; 7Division of Otolaryngology, University of Utah School of Medicine, Salt Lake City, Utah, USA; 8Department Otolaryngology, University of Pennsylvania
Hospital, Philadelphia, Pennsylvania, USA; 9Department of Otolaryngology Head & Neck Surgery, Emory University, Atlanta, Georgia, USA; 10Department of
Internal Medicine, Northwestern University Allergy Division, Chicago, Illinois, USA; 11Consumers United for Evidence-Based Healthcare, Davis, California, USA
12
AAO-HNS, Alexandria,Virginia, USA

Corresponding Author:
Richard M. Rosenfeld, MD, MPH, Chairman and Professor of Otolaryngology, SUNY Downstate Medical Center, Long Island College Hospital, Brooklyn, NY
11201, USA.
Email:

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Rosenfeld et al S3

Guideline Purpose prescriptions than any other diagnosis. Despite guidelines that
The purpose of this multidisciplinary guideline is to identify encourage judicious antibiotic use for ARS,16,19 they are pre-
quality improvement opportunities in managing adult rhinosi- scribed in about 82% of visits.20 From 2006 to 2010, rhinosi-
nusitis and to create explicit and actionable recommendations nusitis accounted for 11% of all primary care antibiotic-related
to implement these opportunities in clinical practice. visits, with ARS accounting for 3.9% and CRS accounting for
Specifically, the goals are to improve diagnostic accuracy for 7.1%.20 ARS and CRS combined accounted for more primary
adult rhinosinusitis, promote judicious use of systemic and ambulatory care visits with antibiotic prescriptions than any
topical therapy, and promote appropriate use of ancillary tests other diagnosis or commonly grouped diagnoses.
to confirm diagnosis and guide management, which include ARS has significant economic implications. The cost of
radiography, nasal endoscopy, computed tomography, and test- antibiotic treatment failure, including additional prescriptions,
ing for allergy and immune function. Emphasis was also placed outpatient visits, tests, and procedures,21 contributes to a sub-
on identifying multiple chronic conditions that would modify stantial total ARS-related health care expenditure of more
management of rhinosinusitis, including asthma, cystic fibro- than $3 billion per year in the United States.5 The average
sis, immunocompromised state, and ciliary dyskinesia. patient with recurrent ARS incurs about $1100 per year in
The guideline is intended for all clinicians who are likely to total direct health costs.22 Aside from the direct treatment
diagnose and manage adults with rhinosinusitis and applies to costs, decreased productivity and lost work days contribute to
any setting in which an adult with rhinosinusitis would be an even greater indirect health care cost associated with ABRS
identified, monitored, or managed. This guideline, however, and recurrent ARS.
does not apply to patients younger than 18 years or to patients CRS also has significant socioeconomic implications. In
of any age with complicated rhinosinusitis. 2001, there were 18.3 million office visits for CRS, most of
The guideline will not consider management of the follow- which resulted in prescription medications.23 Patients with CRS
ing clinical presentations, although differential diagnosis for visit primary care clinicians twice as often as those without the
these conditions and bacterial rhinosinusitis will be discussed: disorder and have 5 times as many prescriptions filled.24 A sur-
allergic rhinitis, eosinophilic nonallergic rhinitis, vasomotor vey in 2007 found that approximately $8.3 billion is spent annu-
rhinitis, invasive fungal rhinosinusitis, allergic fungal rhinosi- ally on CRS, primarily on prescription drugs and office-based
nusitis, vascular headaches, and migraines. Similarly, the care.25 Surgery for CRS, which is performed nearly 250,000
guideline will not consider management of rhinosinusitis in times annually in the United States, averages a cost of $7700
patients with the following modifying factors but will discuss per patient. Average annual per-patient spending is $770, which
the importance of assessing patients with recurrent ARS or increases to $2450 in the year prior to surgery.26
CRS for their presence: cystic fibrosis, immotile cilia disor- The indirect cost of CRS is substantial, making it poten-
ders, ciliary dyskinesia, immune deficiency, prior history of tially more important than the direct cost. CRS accounts for,
sinus surgery, and anatomic abnormalities (eg, deviated nasal on average, 1 to 2 lost workdays per patient per year and 73
septum). million days of restricted activity.24,27 In contrast, those with
Surgical management of CRS is not discussed in this guide- medically refractory CRS miss 18 annual workdays.6 Patients
line because of insufficient evidence (eg, randomized con- with CRS are absent from work because of sinusitis 6.5% of
trolled trials) for evidence-based recommendations. the time, have a 36% reduction in on-the-job effectiveness,
and suffer a 38% loss of productivity.7 Compared with patients
Burden of Rhinosinusitis without CRS, patients with CRS have greater activity limita-
Twelve percent of the US population (nearly 1 in 8 adults) tions, work limitations, and social limitations.22 The overall
reported being diagnosed with rhinosinusitis in the prior 12 annual productivity cost for refractory CRS is estimated at
months in a 2012 national health survey.4 Rhinosinusitis was $10,077 per patient.6
diagnosed more frequently than hay fever (7%), bronchitis CRS can also have a substantial impact on health-related
(4%), or chronic obstructive pulmonary disease (4%), and the quality of life. Patients with CRS referred to otolaryngologists
individuals surveyed were almost as likely to receive a diag- score significantly lower on measures of bodily pain and
nosis of rhinosinusitis as they were of asthma (13%). social functioning than do those with angina, back pain, con-
The broad category of rhinosinusitis in the preceding para- gestive heart failure, and chronic obstructive pulmonary dis-
graph includes ARS and CRS. Most ARS begins when a viral ease.8 Similarly, patients with CRS have health utility scores
upper respiratory infection (URI) extends into the paranasal that are worse than many chronic diseases, including conges-
sinuses, which may be followed by bacterial infection. About tive heart failure, coronary artery disease, and chronic obstruc-
20 million cases of presumed bacterial ARS (ABRS) occur tive pulmonary disease.28 Moreover, treatment of CRS can
annually in the United States,5 rendering it one of the most com- improve health state utility values and substantially reduce
mon conditions encountered by clinicians. The importance of fatigue and bodily pain.28-31
ABRS relates not only to prevalence but also to the potential for Methods
uncommon, but serious, complications that include meningitis,
brain abscess, orbital cellulitis, and orbital abscess.17,18 General Methods and Literature Search
National ambulatory care data from 2006 to 2010 revealed In developing this update of the evidence-based clinical prac-
that rhinosinusitis accounted for more outpatient antibiotic tice guideline, the methods outlined in the AAO-HNSF

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S4 Otolaryngology–Head and Neck Surgery 152(2S)

Guideline Development Manual, third edition, were followed text to immediately follow the action statement. Statements
explicitly.32 about the quality improvement opportunity, level of confi-
An executive summary of the original adult sinusitis guide- dence in the evidence, differences of opinion, intentional
line1 was first sent to a panel of expert reviewers who were vagueness, and any exclusion to which the action statement
asked to assess the key action statements and decide if they does not apply were added to the action statement profiles.
should be revised, be kept as stands, or removed based on rele- These additions reflect the current methodology for guideline
vancy, omissions, or controversies that the guideline spurred development by the AAO-HNSF and conform to the Institute
and to identify any new literature or treatments that might affect of Medicine’s standards for developing trustworthy guide-
the guideline recommendations. The reviewers concluded that lines.2,32 The updated guideline then underwent Guideline
the original guideline action statements remained valid but Implementability Appraisal (GLIA) to appraise adherence to
should be updated with minor modifications. Sugges-tions were methodologic standards, to improve clarity of recommenda-
also made for new key action statements. tions, and to predict potential obstacles to implementation.34
A systematic literature search was performed by an infor- The GUG received summary appraisals in June and modified
mation specialist to identify systematic reviews, clinical prac- an advanced draft of the guideline based on the appraisal.
tice guidelines, and randomized controlled trials published The final draft of the updated clinical practice guideline
since the prior guideline (2007). The original MEDLINE was revised based on comments received during multidisci-
search was updated from December 2006 to March 2014 to plinary peer review, open public comment, and journal edito-
include Medline, National Guidelines Clearinghouse, Cochrane rial peer review. The recommendations contained in the
Database of Systematic Reviews, Excerpta Medica database guideline are based on the best available published data
(EMBASE), Cumulative Index to Nursing and Allied Health through March 2014. Where data were lacking, a combination
(CINAHL), and Web of Science using the search string of clinical experience and expert consensus was used. A
“(sinusit* OR rhinosinusit*).” The initial English-language scheduled review process will occur at 5 years from publica-
search identified 54 potential clinical practice guidelines, 166 tion or sooner if new, compelling evidence warrants earlier
systematic reviews, and 352 randomized controlled trials consideration.
(RCTs). Systematic reviews were emphasized and included if
they met quality criteria of (a) clear objective and methods, (b) Classification of Evidence-Based Statements
an explicit search strategy, and (c) valid data extraction. Guidelines are intended to reduce inappropriate variations in
Additional evidence was identified, as needed, with targeted clinical care, to produce optimal health outcomes for patients,
searches to support needs of the guideline development group and to minimize harm. The evidence-based approach to
in updating sections of the guideline text. After assessing guideline development requires that the evidence supporting
quality and relevance of the initial search results, we retained a policy be identified, appraised, and summarized and that an
5 guidelines, 42 systematic reviews, and 70 RCTs. explicit link between evidence and statements be defined.
The AAO-HNSF assembled a guideline update group Evidence-based statements reflect both the quality of evidence
(GUG) representing the disciplines of otolaryngology–head and the balance of benefit and harm that are anticipated when
and neck surgery, infectious disease, family medicine, allergy the statement is followed. The definitions for evidence-based
and immunology, advanced practice nursing, and a consumer statements35 are listed in Tables 1 and 2.
advocate. The GUG also included a staff liaison from AAO- Guidelines are never intended to supersede professional
HNSF, but this individual was not a voting member of the judgment; rather, they may be viewed as a relative constraint
GUG and served only in an editorial capacity in writing the on individual clinician discretion in a particular clinical cir-
guideline. Although radiology was represented on the original cumstance. Less frequent variation in practice is expected for
guideline development group, they were excluded from the a strong recommendation than might be expected with a rec-
update since the AAO-HNSF had recently published a clinical ommendation. Options offer the most opportunity for practice
consensus statement on imaging for sinusitis.33 We did, how- variability.36 Clinicians should always act and decide in a way
ever, solicit radiology feedback about pertinent statements to that they believe will best serve their individual patients’ inter-
ensure they remained valid and current. ests and needs, regardless of guideline recommendations.
The GUG had several conference calls and one in-person Guidelines represent the best judgment of a team of experi-
meeting, during which comments from the expert panel review enced clinicians and methodologists addressing the scientific
and the literature search were reviewed for each key action evidence for a particular topic.35
statement. The GUG then decided to leave the statement unal- Making recommendations about health practices involves
tered, change slightly, or rewrite the statement based on the value judgments on the desirability of various outcomes asso-
impact of the literature search and the reviewer comments. ciated with management options. Values applied by the GUG
The supporting text was then edited to explain any changes sought to minimize harm, diminish unnecessary and inappro-
from the original key action statement, and the recommenda- priate therapy, and reduce the unnecessary use of systemic
tion level was modified accordingly. antibiotics. A major goal of the panel was to be transparent
The evidence profile for each statement was then converted and explicit about how values were applied and to document
into an action statement profile, which was moved up in the the process.