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## Complete Summary

#### GUIDELINE TITLE

Clinical practice guideline: adult sinusitis.

#### BIBLIOGRAPHIC SOURCE(S)

Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats
TG, Gelzer A, Hamilos D, Haydon RC 3rd, Hudgins PA, Jones S, Krouse HJ,
Lee LH, Mahoney MC, Marple BF, Mitchell CJ, Nathan R, Shiffman RN, Smith
TL, Witsell DL. Clinical practice guideline: adult sinusitis.
Otolaryngol Head Neck Surg 2007 Sep;137(3 Suppl):S1-31. \[233
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17761281)

#### GUIDELINE STATUS

This is the current release of the guideline.

A scheduled review process will occur at 5 years from publication or
sooner if new compelling evidence warrants earlier consideration.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Rhinosinusitis, defined as symptomatic inflammation of the paranasal
sinuses and nasal cavity

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Prevention\
Treatment

#### CLINICAL SPECIALTY

Allergy and Immunology\
Emergency Medicine\
Family Practice\
Infectious Diseases\
Internal Medicine\
Nursing\
Otolaryngology\
Preventive Medicine\
Pulmonary Medicine\
Radiology

#### INTENDED USERS

Allied Health Personnel\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

-   To improve diagnostic accuracy for adult rhinosinusitis, reduce
    inappropriate antibiotic use, reduce inappropriate use of
    radiographic imaging, and promote appropriate use of ancillary tests
    that include nasal endoscopy, computed tomography, and testing for
    allergy and immune function

-   To create a guideline suitable for deriving a performance measure on
    rhinosinusitis and training participants in guideline methodology to
    facilitate future development efforts

#### TARGET POPULATION

Adults 18 years or older with a clinical diagnosis of uncomplicated
rhinosinusitis

**Note**: *Uncomplicated rhinosinusitis* is defined as rhinosinusitis
without clinically evident extension of inflammation outside the
paranasal sinuses and nasal cavity at the time of diagnosis (e.g., no
neurologic, ophthalmologic, or soft tissue involvement).

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis/Evaluation**

1.  Targeted history

2.  Physical examination

3.  Anterior rhinoscopy

4.  Transillumination

5.  Nasal endoscopy

6.  Nasal swabs

7.  Antral puncture

8.  Culture of nasal cavity, middle meatus, or other site

9.  Imaging procedures

10. Blood tests: complete blood count (CBC), others

11. Allergy evaluation and testing

12. Immune function testing

13. Gastroesophageal reflux

14. Pulmonary function tests

15. Mucociliary dysfunction tests

**Treatment/Management**

1.  Watchful waiting/observation

2.  Education/information

3.  Systemic antibiotics

4.  Topical antibiotics

5.  Oral/topical steroids

6.  Systemic/topical decongestants

7.  Antihistamines

8.  Mucolytics

9.  Leukotriene modifiers

10. Nasal saline

11. Analgesics

12. Complementary and alternative medicine

13. Postural drainage/heat

14. Biopsy (excluded from guideline)

15. Sinus surgery (excluded from guideline)

**Prevention**

1.  Topical steroids

2.  Immunotherapy

3.  Nasal lavage

4.  Smoking cessation

5.  Hygiene

6.  Education

7.  Pneumococcal vaccination

8.  Influenza vaccination

9.  Environmental controls

#### MAJOR OUTCOMES CONSIDERED

-   Resolution or change of the signs and symptoms associated with
    rhinosinusitis

-   Eradication of pathogens

-   Recurrence of acute disease

-   Complications or adverse events

-   Cost

-   Adherence to therapy

-   Quality of life

-   Return to work or activity

-   Avoidance of surgery

-   Return physician visits

-   Effect on comorbid conditions (e.g., allergy, asthma,
    gastroesophageal reflux)

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Several literature searches were performed through November 30, 2006 by
American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)
staff. The initial MEDLINE search using \"sinusitis OR rhinosinusitis\"
in any field, or \"sinus\* AND infect\*\" in the title or abstract,
yielded 18,020 potential articles:

1.  *Clinical practice guidelines* were identified by limiting the
    MEDLINE search to 28 articles using \"guideline\" as a publication
    type or title word. Search of the National Guideline Clearinghouse
    ([www.guideline.gov](http://www.guideline.gov/)) identified 59
    guidelines with a topic of sinusitis or rhinosinusitis. After
    eliminating articles that did not have rhinosinusitis as the primary
    focus, 12 guidelines met quality criteria of being produced under
    the auspices of a medical association or organization and having an
    explicit method for ranking evidence and linking evidence to
    recommendations.

2.  *Systematic reviews (meta-analyses)* were identified by limiting the
    MEDLINE search to 226 articles using a validated filter strategy for
    systematic reviews. Search of the Cochrane Library identified 71
    relevant titles. After eliminating articles that did not have
    rhinosinusitis as the primary focus, 18 systematic reviews met
    quality criteria of having explicit criteria for conducting the
    literature and selecting source articles for inclusion or exclusion.

3.  *Randomized controlled trials* were identified by search of the
    Cochrane Controlled Trials Register, which identified 515 trials
    with \"sinusitis\" or \"rhinosinusitis\" as a title word.

4.  *Original research studies* were identified by limiting the MEDLINE
    search to articles with a sinusitis (MeSH term) as a focus,
    published in English after 1991, not containing children age 12
    years or younger and not having a publication type of case report.
    The resulting data set of 2039 articles yielded 348 related to
    diagnosis, 359 to treatment, 151 to etiology, and 24 to prognosis.

#### NUMBER OF SOURCE DOCUMENTS

-   *Clinical practice guidelines*: 12

-   *Systematic reviews (meta-analyses)*: 18

-   *Randomized controlled trials*: 515

-   *Original research studies*: 348 related to diagnosis, 359 to
    treatment, 151 to etiology, and 24 to prognosis

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)\
Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Evidence Quality for Grades of Evidence**

**Grade A**: Well-designed randomized controlled trials or diagnostic
studies performed on a population similar to the guideline\'s target
population

**Grade B**: Randomized controlled trials or diagnostic studies with
minor limitations; overwhelmingly consistent evidence from observational
studies

**Grade C**: Observational studies (case control and cohort design)

**Grade D**: Expert opinion, case reports, reasoning from first
principles (bench research or animal studies)

**Grade X**: Exceptional situations where validating studies cannot be
performed and there is a clear preponderance of benefit over harm

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The guideline was developed using an explicit and transparent a priori
protocol for creating actionable statements based on supporting evidence
and the associated balance of benefit and harm. The multidisciplinary
guideline development panel was chosen to represent the fields of
allergy, emergency medicine, family medicine, health insurance,
immunology, infectious disease, internal medicine, medical informatics,
nursing, otolaryngology--head and neck surgery, and radiology.

Results of all literature searches were distributed to guideline panel
members at the first meeting. The materials included an evidence table
of clinical practice guidelines, an evidence table of systematic
reviews, full-text electronic versions of all articles in the evidence
tables, and electronic listings with abstracts (if available) of the
searches for randomized trials and original research. This material was
supplemented, as needed, with targeted searches to address specific
needs identified in writing the guideline.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

In a series of conference calls, the working group defined the scope and
objectives of the proposed guideline. During the 9 months devoted to
guideline development ending in April 2007, the group met twice with
interval electronic review and feedback on each guideline draft to
ensure accuracy of content and consistency with standardized criteria
for reporting clinical practice guidelines.

The Guidelines Review Group of the Yale Center for Medical Informatics
used the Guideline Elements Module from the Conference on Guidelines
Standardization (GEM-COGS), the guideline implementability appraisal and
extractor software, to appraise adherence of the draft guideline to
methodologic standards, to improve clarity of recommendations, and to
predict potential obstacles to implementation. Panel members received
summary appraisals in March 2007 and modified an advanced draft of the
guideline.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Guideline Definitions for Evidence-Based Statements**

**Strong Recommendation**: A strong recommendation means the benefits of
the recommended approach clearly exceed the harms (or that the harms
clearly exceed the benefits in the case of a strong negative
recommendation) and that the quality of the supporting evidence is
excellent (Grade A or B)\*. In some clearly identified circumstances,
strong recommendations may be made based on lesser evidence when
high-quality evidence is impossible to obtain and the anticipated
benefits strongly outweigh the harms. *Implication*: Clinicians should
follow a strong recommendation unless a clear and compelling rationale
for an alternative approach is present.

**Recommendation**: A recommendation means the benefits exceed the harms
(or that the harms exceed the benefits in the case of a negative
recommendation), but the quality of evidence is not as strong (Grade B
or C)\*. In some clearly identified circumstances, recommendations may
be made based on lesser evidence when high-quality evidence is
impossible to obtain and the anticipated benefits outweigh the harms.
*Implication*: Clinicians also should generally follow a recommendation
but should remain alert to new information and sensitive to patient
preferences.

**Option**: An option means that either the quality of evidence that
exists is suspect (Grade D)\* or that well-done studies (Grade A, B, or
C)\* show little clear advantage to one approach versus another.
*Implication*: Clinicians should be flexible in their decision-making
regarding appropriate practice, although they may set bounds on
alternatives; patient preference should have a substantial influencing
role.

**No Recommendation**: No recommendation means that there is both a lack
of pertinent evidence (Grade D)\* and an unclear balance between
benefits and harms. *Implication*: Clinicians should feel little
constraint in their decision-making and be alert to new published
evidence that clarifies the balance of benefit versus harm; patient
preference should have a substantial influencing role.

\* Refer to \"Rating Scheme for the Strength of the Evidence\" field
above for the definitions of evidence grades.

#### COST ANALYSIS

The direct annual health-care cost of sinusitis is \$5.8 billion, which
stems mainly from ambulatory and emergency department services, but also
includes 500,000 surgical procedures performed on the paranasal sinuses.
The indirect costs of sinusitis include 73 million days of restricted
activity per year.

Acute bacterial rhinosinusitis (ABRS) has significant socioeconomic
implications. The cost of initial antibiotic treatment failure in ABRS,
including additional prescriptions, outpatient visits, tests, and
procedures, contributes to a substantial total rhinosinusitis related
health-care expenditure of more than \$3.0 billion per year in the
United States. Aside from the direct treatment costs, decreased
productivity and lost work days contribute to an even greater indirect
health-care cost associated with this condition.

Chronic rhinosinusitis (CRS) has significant socioeconomic implications.
In 2001 there were 18.3 million office visits for CRS, most of which
resulted in prescription medications. Patients with CRS visit primary
care clinicians twice as often as those without the disorder, and have
five times as many prescriptions filled. Extrapolation of these data
yields an annual direct cost for CRS of \$4.3 billion.

The following cost considerations were addressed with the
recommendations:

-   Diagnosis of Acute Rhinosinusitis: not applicable

-   Radiographic Imaging and Acute Rhinosinusitis: savings by not
    performing routine radiologic imaging

-   Symptomatic Relief of Viral Rhinosinusitis (VRS): cost of
    medications

-   Pain Assessment of Acute Bacterial Rhinosinusitis (ABRS): cost of
    analgesic medications

-   Symptomatic Relief of ABRS: cost of medications

-   Watchful Waiting for ABRS: antibiotics; potential need for follow-up
    visit if observation failure

-   Choice of Antibiotic for ABRS: cost of antibiotics

-   Treatment Failure for ABRS: medication cost

-   Diagnosis of Chronic Rhinosinusitis or Recurrent Acute
    Rhinosinusitis: none

-   Modifying Factors: variable based on testing ordered

-   Diagnostic Testing: relates to the specific test or procedure

-   Nasal Endoscopy: procedural cost

-   Radiographic Imaging: procedural cost

-   Testing for Allergy and Immune Function: procedural and laboratory
    cost

-   Prevention: minimal

#### METHOD OF GUIDELINE VALIDATION

External Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The final draft practice guideline underwent extensive external peer
review. Comments were compiled and reviewed by the group chairperson.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The evidence grades (**A-D**) and evidence-based statements (**Strong
Recommendation, Recommendation, Option, and No Recommendation**) are
defined at the end of the \"Major Recommendations\" field.

**1a. Diagnosis of Acute Rhinosinusitis**

Clinicians should distinguish presumed acute bacterial rhinosinusitis
(ABRS) from acute rhinosinusitis caused by viral upper respiratory
infections and noninfectious conditions. A clinician should diagnose
ABRS when (a) symptoms or signs of acute rhinosinusitis are present 10
days or more beyond the onset of upper respiratory symptoms, or (b)
symptoms or signs of acute rhinosinusitis worsen within 10 days after an
initial improvement (double worsening).

*Strong recommendation based on diagnostic studies with minor
limitations and a preponderance of benefit over harm.*

-   Aggregate evidence quality: **Grade B**, diagnostic students with
    minor limitations regarding signs and symptoms associated with ABRS

-   Value judgments: importance of avoiding inappropriate antibiotic
    treatment of viral or nonbacterial illness; emphasis on clinical
    signs and symptoms for initial diagnosis; importance of avoiding
    unnecessary diagnostic tests

-   Policy level: **strong recommendation**

**1b. Radiographic Imaging and Acute Rhinosinusitis**

Clinicians should not obtain radiographic imaging for patients who meet
diagnostic criteria for acute rhinosinusitis, unless a complication or
alternative diagnosis is suspected.

*Recommendation against based on diagnostic studies with minor
limitations and a preponderance of benefit over harm.*

-   Aggregate evidence quality: **Grade B**, diagnostic studies with
    minor limitations

-   Value judgments: importance of avoiding unnecessary radiation and
    cost in diagnosing acute rhinosinusitis

-   Policy level: **recommendation**

**2. Symptomatic Relief of Viral Rhinosinusitis (VRS)**

Clinicians may prescribe symptomatic relief in managing VRS.

*Option based on randomized trials with limitations and cohort studies
with an unclear balance of benefits and harm that varies by patient.*

-   Aggregate evidence quality: **Grade B and C**, randomized controlled
    trials with limitations and cohort studies

-   Value judgments: provide symptomatic relief, but avoid inappropriate
    use of antibiotics for viral illness

-   Policy level: **option**

**3a. Pain Assessment of Acute Bacterial Rhinosinusitis (ABRS)**

The management of ABRS should include an assessment of pain. The
clinician should recommend analgesic treatment based on the severity of
pain.

*Strong recommendation based on randomized controlled trials of general
pain relief in non-ABRS populations with a preponderance of benefit over
harm.*

-   Aggregate evidence quality: **Grade B**, randomized controlled
    trials demonstrating superiority of analgesics over placebo for
    general pain relief, but not trials specifically regarding patients
    with ABRS.

-   Value judgments: pain relief is important

-   Policy level: **strong recommendation**

**3b. Symptomatic Relief of Acute Bacterial Rhinosinusitis (ABRS)**

Clinicians may prescribe symptomatic relief in managing ABRS.

*Option based on randomized trials with heterogeneous populations,
diagnostic criteria, and outcome measures with a balance of benefit and
harm.*

-   Aggregate evidence quality: **Grade B**, randomized controlled
    trials with heterogeneous populations, diagnostic criteria, and
    outcomes measures; **Grade D**, for antihistamines (in nonatopic
    patients) and guaifenesin

-   Value judgments: provide symptomatic relief while minimizing adverse
    events and costs

-   Policy level: **option**

**4. Watchful Waiting for Acute Bacterial Rhinosinusitis (ABRS)**

Observation without use of antibiotics is an option for selected adults
with uncomplicated ABRS who have mild illness (mild pain and temperature
\<38.3°C or 101°F) and assurance of follow-up.

*Option based on double-blind randomized controlled trials with
heterogeneity in diagnostic criteria and illness severity, and a
relative balance of benefit and risk.*

-   Aggregate evidence quality: **Grade B**, randomized controlled
    trials with heterogeneity in diagnostic criteria and illness
    severity

-   Value judgments: minimize drug-related adverse events and induced
    bacterial resistance

-   Policy level: **option**

**5. Choice of Antibiotic for Acute Bacterial Rhinosinusitis (ABRS)**

If a decision is made to treat ABRS with an antibiotic agent, the
clinician should prescribe amoxicillin as first-line therapy for most
adults.

*Recommendation based on randomized controlled trials with heterogeneity
and noninferiority design with a preponderance of benefit over harm*.

-   Aggregate evidence quality: **Grade B**, randomized controlled
    trials with heterogeneity and noninferiority design

-   Value judgments: promote safe and cost-effective initial therapy

-   Policy level: **recommendation**

**6. Treatment Failure for Acute Bacterial Rhinosinusitis (ABRS)**

If the patient worsens or fails to improve with the initial management
option by 7 days after diagnosis, the clinician should reassess the
patient to confirm ABRS, exclude other causes of illness, and detect
complications. If ABRS is confirmed in the patient initially managed
with observation, the clinician should begin antibiotic therapy. If the
patient was initially managed with an antibiotic, the clinician should
change the antibiotic.

*Recommendation based on randomized controlled trials with limitations
supporting a cut point of 7 days for lack of improvement and expert
opinion and first principles for changing therapy with a preponderance
of benefit over harm.*

-   Aggregate evidence quality: **Grade B**, randomized controlled
    trials with limitations supporting a cut point of 7 days for lack of
    improvement; **Grade D**, expert opinion and first principles for
    changing therapy

-   Value judgments: avoid excessive classification as treatment
    failures because of a premature time point for assessing outcomes;
    emphasize importance of worsening illness in definition of treatment
    failure

-   Policy level: **recommendation**

**7a. Diagnosis of Chronic Rhinosinusitis or Recurrent Acute
Rhinosinusitis**

Clinicians should distinguish chronic rhinosinusitis and recurrent acute
rhinosinusitis from isolated episodes of acute bacterial rhinosinusitis
and other causes of sinonasal symptoms.

*Recommendation based on cohort and observational studies with a
preponderance of benefit over harm.*

-   Aggregate evidence quality: **Grade C**, cohort and observational
    studies

-   Value judgments: importance of accurate diagnosis

-   Policy level: **recommendation**

**7b. Modifying Factors**

Clinicians should assess the patient with chronic rhinosinusitis or
recurrent acute rhinosinusitis for factors that modify management, such
as allergic rhinitis, cystic fibrosis, immunocompromised state, ciliary
dyskinesia, and anatomic variation.

*Recommendation based on observational studies with a preponderance of
benefit over harm.*

-   Aggregate evidence quality: **Grade C,** observational studies

-   Value judgments: consensus that identifying and managing modifying
    factors will improve outcomes

-   Policy level: **recommendation**

**8a. Diagnostic Testing**

The clinician should corroborate a diagnosis and/or investigate for
underlying causes of chronic rhinosinusitis and recurrent acute
rhinosinusitis.

*Recommendation based on observational studies with a preponderance of
benefit over harm.*

-   Aggregate evidence quality: **Grade C**, observational studies

-   Value judgments: identifying and managing underlying conditions will
    improve outcomes

-   Policy level: **recommendation**

**8b. Nasal Endoscopy**

The clinician may obtain nasal endoscopy in diagnosing or evaluating a
patient with chronic rhinosinusitis or recurrent acute rhinosinusitis.

*Option based on expert opinion and a preponderance of benefit over
harm.*

-   Aggregate evidence quality: **Grade D**, expert opinion

-   Value judgments: importance of a detailed, complete intranasal
    examination

-   Policy level: **option**

**8c. Radiographic Imaging**

The clinician should obtain computed tomography (CT) of the paranasal
sinuses in diagnosing or evaluating a patient with chronic
rhinosinusitis or recurrent acute rhinosinusitis.

*Recommendation based on diagnostic and observational studies and a
preponderance of benefit over harm.*

-   Aggregate evidence quality: **Grade C**, diagnostic and
    observational studies

-   Value judgments: minimize radiation exposure and avoid unnecessary
    intravenous contrast

-   Policy level: **recommendation**

**8d. Testing for Allergy and Immune Function**

The clinician may obtain testing for allergy and immune function in
evaluating a patient with chronic rhinosinusitis or recurrent acute
rhinosinusitis.

*Option based on observational studies with an unclear balance of
benefit versus harm.*

-   Aggregate evidence quality: **Grade C**, observational studies

-   Value judgments: need to balance detecting allergy in a population
    with high prevalence vs. limited evidence showing benefits of
    allergy management on rhinosinusitis outcomes

-   Policy level: **option**

**9. Prevention**

Clinicians should educate/counsel patients with chronic rhinosinusitis
or recurrent acute rhinosinusitis regarding control measures.

*Recommendation based on randomized controlled trials and epidemiologic
studies with limitations and a preponderance of benefit over harm.*

-   Aggregate evidence quality: **Grade B**, randomized controlled
    trials and epidemiologic studies with limitations

-   Value judgments: importance of prevention in managing patients with
    CRS or recurrent acute rhinosinusitis

-   Policy level: **recommendation**

**[Definitions]{.underline}**:

**Guideline Definitions for Evidence-Based Statements**

**Strong Recommendation**: A strong recommendation means the benefits of
the recommended approach clearly exceed the harms (or that the harms
clearly exceed the benefits in the case of a strong negative
recommendation) and that the quality of the supporting evidence is
excellent (Grade A or B)\*. In some clearly identified circumstances,
strong recommendations may be made based on lesser evidence when
high-quality evidence is impossible to obtain and the anticipated
benefits strongly outweigh the harms. *Implication*: Clinicians should
follow a strong recommendation unless a clear and compelling rationale
for an alternative approach is present.

**Recommendation**: A recommendation means the benefits exceed the harms
(or that the harms exceed the benefits in the case of a negative
recommendation), but the quality of evidence is not as strong (Grade B
or C)\*. In some clearly identified circumstances, recommendations may
be made based on lesser evidence when high-quality evidence is
impossible to obtain and the anticipated benefits outweigh the harms.
*Implication*: Clinicians also should generally follow a recommendation
but should remain alert to new information and sensitive to patient
preferences.

**Option**: An option means that either the quality of evidence that
exists is suspect (Grade D)\* or that well-done studies (Grade A, B, or
C)\* show little clear advantage to one approach versus another.
*Implication*: Clinicians should be flexible in their decision-making
regarding appropriate practice, although they may set bounds on
alternatives; patient preference should have a substantial influencing
role.

**No Recommendation**: No recommendation means that there is both a lack
of pertinent evidence (Grade D)\* and an unclear balance between
benefits and harms. *Implication*: Clinicians should feel little
constraint in their decision-making and be alert to new published
evidence that clarifies the balance of benefit versus harm; patient
preference should have a substantial influencing role.

**Evidence Quality for Grades of Evidence**

**Grade A**: Well-designed, randomized, controlled trials or diagnostic
studies performed on a population similar to the guideline\'s target
population

**Grade B**: Randomized, controlled trials or diagnostic studies with
minor limitations; overwhelmingly consistent evidence from observational
studies

**Grade C**: Observational studies (case-control and cohort design)

**Grade D**: Expert opinion, case reports, or reasoning from first
principles (bench research or animal studies)

**Grade X**: Exceptional situations where validating studies cannot be
performed and there is a clear preponderance of benefit over harm

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations contained in this practice guideline were based on
the best available published data through January 2007. Where data were
lacking a combination of clinical experience and expert consensus was
used. The type of supporting evidence is identified and graded for each
recommendation (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Diagnosis of acute rhinosinusitis: decrease inappropriate use of
    antibiotics for non bacterial illness; distinguish noninfectious
    conditions from rhinosinusitis

-   Radiographic imaging and acute rhinosinusitis: avoid unnecessary
    radiation exposure; avoid delays in diagnosis from obtaining and
    interpreting imaging studies

-   Symptomatic relief of viral rhinosinusitis (VRS): reduction of
    symptoms; avoidance of unnecessary antibiotics

-   Pain assessment of acute bacterial rhinosinusitis (ABRS): pain
    reduction

-   Symptomatic relief of ABRS: symptom relief

-   Watchful waiting for ABRS: increase in cure or improvement at 7 to
    12 days (number needed to treat \[NNT\] 6), and improvement at 14 to
    15 days (NNT 16); reduced illness duration

-   Choice of antibiotic for ABRS: demonstrated superiority of
    amoxicillin over placebo, with clinical outcomes comparable to
    broader-spectrum antibiotics for initial therapy; potential reduced
    bacterial resistance by using a narrow-spectrum antibiotic as
    first-line therapy; cost-effectiveness of amoxicillin versus other
    antibiotic choices

-   Treatment failure for ABRS: prevent complications, detect
    misdiagnosis, institute effective therapy

-   Diagnosis of chronic rhinosinusitis (CRS) or recurrent acute
    rhinosinusitis: distinguish conditions that might benefit from
    additional diagnostic evaluation and management from isolated cased
    of ABRS

-   Modifying factors: identify modifying factors that would alter
    management of CRS or recurrent acute rhinosinusitis; identify
    conditions that require therapy independent of rhinosinusitis

-   Diagnostic testing: corroborate diagnosis and identify underlying
    causes that may require management independent of rhinosinusitis for
    symptom relief

-   Nasal endoscopy: confirm diagnosis of CRS; detect structural
    abnormalities, masses, lesions; perform biopsy or culture

-   Radiographic imaging: confirm diagnosis of CRS; detect structural
    abnormalities, masses, lesions

-   Testing for allergy and immune function: identify allergies or
    immunodeficient states that are potential modifying factors for CRS
    or recurrent acute rhinosinusitis

-   Prevention: reduce symptoms and prevent exacerbations

#### POTENTIAL HARMS

-   Diagnosis of acute rhinosinusitis: risk of misclassifying bacterial
    rhinosinusitis as viral, or vice-versa

-   Radiographic imaging and acute rhinosinusitis: delayed diagnosis of
    serious underlying condition

-   Symptomatic relief of viral rhinosinusitis (VRS): adverse effects of
    decongestants, antihistamines, topical steroid sprays

-   Pain assessment of acute bacterial rhinosinusitis (ABRS): side
    effects of analgesic medications; potential for masking underlying
    illness or disease progression

-   Symptomatic relief of ABRS: side effects of medication, which
    include local and systemic adverse reactions

-   Watchful waiting for ABRS: adverse effects of specific antibiotics
    (number needed to harm \[NNH\] 9), especially gastrointestinal;
    societal impact of antibiotic therapy on bacterial resistance and
    transmission of resistant pathogens; potential disease progression
    in patients initially observed who do not return for follow-up

-   Choice of antibiotic for ABRS: potential increased gastrointestinal
    adverse effects with amoxicillin compared to other antibiotics;
    adverse effects from penicillin allergy

-   Treatment failure for ABRS: delay of up to 7 days in changing
    therapy if patient fails to improve

-   Diagnosis of chronic rhinosinusitis (CRS) or recurrent acute
    rhinosinusitis: potential misclassification of illness because of
    overlapping symptomatology with other illnesses

-   Modifying factors: identifying and treating incidental findings or
    subclinical conditions that might not require independent therapy;
    morbidity related to specific tests

-   Diagnostic testing: related to the specific test or procedure

-   Nasal endoscopy: adverse effects from topical decongestants,
    anesthetics, or both; discomfort; hemorrhage; trauma

-   Radiographic imaging: radiation exposure

-   Testing for allergy and immune function: procedural discomfort;
    instituting therapy based on test results with limited evidence of
    efficacy for CRS or recurrent acute rhinosinusitis; very rare chance
    of anaphylactic reactions during allergy testing

-   Prevention: local irritation from saline irrigation

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Patients with penicillin allergy may receive a macrolide antibiotic or
trimethoprim-sulfamethoxazole.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   This clinical practice guideline is not intended as a sole source of
    guidance for managing adults with rhinosinusitis. Rather, it is
    designed to assist clinicians by providing an evidence-based
    framework for decision-making strategies. It is not intended to
    replace clinical judgment or establish a protocol for all
    individuals with this condition, and may not provide the only
    appropriate approach to diagnosing and managing this problem.

-   As medical knowledge expands and technology advances, clinical
    indicators and guidelines are promoted as conditional and
    provisional proposals of what is recommended under specific
    conditions, but they are not absolute. Guidelines are not mandates
    and do not and should not purport to be a legal standard of care.
    The responsible physician, in light of all the circumstances
    presented by the individual patient, must determine the appropriate
    treatment. Adherence to these guidelines will not ensure successful
    patient outcomes in every situation. The American Academy of
    Otolaryngology--Head and Neck Surgery (AAO-HNS), Inc. emphasizes
    that these clinical guidelines should not be deemed inclusive of all
    proper treatment decisions or methods of care, or exclusive of other
    treatment decisions or methods of care reasonably directed to
    obtaining the same results.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

**Implementation Considerations**

The complete guideline is published as a supplement to
*Otolaryngology--Head and Neck Surgery* to facilitate reference and
distribution. The guideline will be presented to American Academy of
Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) members as a
miniseminar at the annual meeting following publication. Existing
brochures and publications by the AAO-HNSF will be updated to reflect
the guideline recommendations.

An anticipated barrier to the diagnosis of rhinosinusitis is the
differentiation of viral rhinosinusitis (VRS) from acute bacterial
rhinosinusitis (ABRS) in a busy clinical setting. This may be assisted
by a laminated teaching card or visual aid summarizing diagnostic
criteria and the time course of VRS. When diagnosed with VRS, patients
may pressure clinicians for antibiotics, in addition to symptomatic
therapy, especially when nasal discharge is colored or purulent.
Existing educational material from the Centers for Disease Control and
Prevention (CDC) Get Smart Campaign can be used by clinicians to help
clarify misconceptions about viral illness and nasal discharge.

Anticipated barriers to using the \"observation option\" for ABRS are
reluctance of patients and clinicians to consider observing a presumed
bacterial illness, and misinterpretation by clinicians and lay press of
the statement regarding observation of ABRS as a \"recommendation\"
instead of an \"option.\" These barriers can be overcome with
educational pamphlets and information sheets that outline the favorable
natural history of nonsevere ABRS, the moderate incremental benefit of
antibiotics on clinical outcomes, and the potential adverse effects of
orally administered antibiotics (including induced bacterial
resistance).

Some patients and clinicians might object to amoxicillin as first-line
therapy for ABRS, based on assumptions that newer, more expensive
alternatives \"must be\" more effective. Most favorable clinical
outcomes for nonsevere ABRS, however, result from natural history, not
antibiotics, and randomized trials of comparative efficacy do not
support superiority of any single agent for initial empiric therapy.
Pamphlets may help in dispelling myths about comparative efficacy.

Barriers may also be anticipated concerning guideline statements for
chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis. The
diagnostic criteria for these entities are unfamiliar to many
clinicians, who might benefit from a summary card or teaching aid that
lists these criteria along with those for ABRS and VRS. Performance of
nasal endoscopy, allergy evaluation, and immunologic assessment, when
appropriate, may be hindered by access to equipment and by procedural
cost. Last, successfully achieving smoking cessation in patients with
CRS or recurrent acute rhinosinusitis will require patient cooperation
and clinician access to education materials and support services.

#### IMPLEMENTATION TOOLS

Patient Resources

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats
TG, Gelzer A, Hamilos D, Haydon RC 3rd, Hudgins PA, Jones S, Krouse HJ,
Lee LH, Mahoney MC, Marple BF, Mitchell CJ, Nathan R, Shiffman RN, Smith
TL, Witsell DL. Clinical practice guideline: adult sinusitis.
Otolaryngol Head Neck Surg 2007 Sep;137(3 Suppl):S1-31. \[233
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17761281)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2007 Sep

#### GUIDELINE DEVELOPER(S)

American Academy of Otolaryngology - Head and Neck Surgery Foundation -
Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Academy of Otolaryngology\--Head and Neck Surgery Foundation

#### GUIDELINE COMMITTEE

American Academy of Otolaryngology\--Head and Neck Surgery Guidelines
Development Task Force

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Primary Authors*: Richard M. Rosenfeld, MD, MPH, David Andes, MD, Neil
Bhattacharyya, MD, Dickson Cheung, MD, MBA, MPH-C, Steven Eisenberg, MD,
Theodore G. Ganiats, MD, Andrea Gelzer, MD, MS, Daniel Hamilos, MD,
Richard C. Haydon III, MD, Patricia A. Hudgins, MD, Stacie Jones, MPH,
Helene J. Krouse, PhD, Lawrence H. Lee, MD, Martin C. Mahoney, MD, PhD,
Bradley F. Marple, MD, Col. John P. Mitchell, MC, MD, Robert Nathan, MD,
Richard N. Shiffman, MD, MCIS, Timothy L. Smith, MD, MPH, David L.
Witsell, MD, MHS

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Richard M Rosenfeld, Nothing to disclose. David Andes, Speaking and
grant support for non-sinusitis related research: Schering Plough,
Pfizer, Merck, Astellas, Peninsula. Dickson Cheung, Nothing to disclose.
Neil Bhattacharyya, Grant support from ArthroCare Corporation. Steven
Eisenberg, Employed by BC/BS of Minnesota, Phoenix Healthcare
Intelligence, and UnitedHealthcare; consultant to the Minnesota DHHS,
Pfizer Healthcare Solutions, Pharmetrics, Inc. and ProfSoft, Inc.;
editor Disease Management. Ted Ganiats, Nothing to disclose. Andrea
Gelzer, Employed by CIGNA HealthCare. Daniel Hamilos, Consultant for
Sinexus, Accentia, Isis, Novartis, Schering, and Genentech; speakers\'
bureau for Merck and Genentech. Richard C. Haydon III, Speakers bureau
Sanofi-Aventis/Merck; advisory board for Alk-Abello, Alcon, Altara &
Glaxo-Smith Klein. Patricia A. Hudgins, Nothing to disclose. Stacie
Jones, Nothing to disclose. Helene J Krouse, PhD, Grant support
Schering-Plough, speakers bureau Sanofi-Aventis, consultant Krames
Communication; stockholder - Alcon, Merck, Medtronic, Schering-Plough,
Pfizer, Genentech, and Viropharma. Lawrence H. Lee, Employed by
United-Healthcare. Martin C. Mahoney, Nothing to disclose. Bradley F.
Marple, Speaker\'s bureau-Glaxo Smith Kline, Sanofi Aventis, Merck,
Alcon, Bayer, Altana, Pfizer, Abbott; Advisory Board - Abbott,
Glaxo-Smith-Kline, Sanofi-Aventis, Alcon, Bayer, Schering, Altana,
Novacal, Allux, Xomed-Medtronics, Replidyne, Greer, ALK-Abello, Critical
Therapeutics, MedPoint; Consultant-Alcon, Xomed-Medtronic, Accentia;
Stock options- Allux, Novacal. John P. Mitchell, Nothing to disclose.
Robert Nathan, Consultant/Scientific Advisor: Amgen, AstraZeneca,
Aventis, Genentech, GlaxoSmith, Merck, Novartis, Pfizer, Schering/Key,
Sepracor, Viropharm; Grant/Research Support: 3-M Pharmaceuticals,
Abbott, AstraZeneca, Aventis, Bayer, Berlex, Bohringer Ingelheim,
Bristol-Myers Squibb, Ciba-Geigy, Dura, Forest, GlaxoSmithKline,
Immunex, Janssen, Parke-Davis, Pfizer, Proctor & Gamble, Roberts,
Sandoz, Sanofi Schering/Key, Sepracor, Sterling, Tap Pharmaceuticals,
Wallace, Wyeth. Richard N. Shiffman, Nothing to disclose. Timothy L.
Smith, Research grant from NIH, consultant for Acclarent. David L
Witsell, Nothing to disclose.

#### GUIDELINE STATUS

This is the current release of the guideline.

A scheduled review process will occur at 5 years from publication or
sooner if new compelling evidence warrants earlier consideration.

#### GUIDELINE AVAILABILITY

Electronic copies: Available to subscribers of the [Otolaryngology -
Head and Neck Surgery
journal](http://journals.elsevierhealth.com/periodicals/ymhn).

Print copies: Available from Richard M. Rosenfeld, MD, MPH, Department
of Otolaryngology, 339 Hicks Street, Brooklyn, NY 11201-5514; E-mail:
<richrosenfeld@msn.com>

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   Rosenfeld RM. Executive summary. Clinical practice guideline on
    adult sinusitis. Otolaryngol Head Neck Surg 2007. Electronic copies:
    Available to subscribers of the [Otolaryngology - Head and Neck
    Surgery
    journal](http://journals.elsevierhealth.com/periodicals/ymhn).

#### PATIENT RESOURCES

The following is available:

-   Fact sheet: Do I have sinusitis? Electronic copies available from
    the [American Academy of Otolaryngology-Head and Neck Surgery
    (AAO-HNS) Web
    site](http://journals.elsevierhealth.com/periodicals/ymhn/home).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI Institute on August 5, 2008. The
information was verified by the guideline developer on August 7, 2008.

#### COPYRIGHT STATEMENT

Permission is granted to reproduce the aforementioned material in
**print and electronic format** at no charge subject to the following
conditions:

1.  If any part of the material to be used (for example, figures) has
    appeared in our publication with credit or acknowledgement to
    another source, permission must also be sought from that source.  If
    such permission is not obtained then that material may not be
    included in your publication/copies.

2.  Suitable acknowledgement to the source must be made, either as a
    footnote or in a reference list at the end of your publication, as
    follows:

> \"Reprinted from Publication title, Vol number, Author(s), Title of
> article, Pages No., Copyright (Year), with permission from American
> Academy of Otolaryngology -- Head and Neck Surgery Foundation, Inc.\"

3.  Reproduction of this material is confined to the purpose for which
    permission is hereby given.

4.  This permission is granted for non-exclusive world
    **[English]{.underline}** rights only. For other languages please
    reapply separately for each one required.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
associations, public or private organizations, other government
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Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
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Date Modified: 11/3/2008