- Email: [email protected]
Rhinosinusitis treatment protocol: Changing provider habits in primary care
Rhinosinusitis treatment protocol: Changing provider habits in primary care WILLIAM C. KINNEY,
MD, MHA,
Columbia, Missouri
OBJECTIVE: Sinus infections are common and represent a high cost to the health care industry. Clinical protocols can be used to develop cost-effective treatment strategies. Our objective was to show that a protocol for rhinosinusitis can change provider practice patterns in primary care. STUDY DESIGN AND SETTING: We used a literature search, survey of primary caregivers, and chart review from an academic health center to define and document current patterns. A protocol was developed and evaluated using the Rhinosinusitis Disability Index. RESULTS: Survey and chart review identified that primary caregivers do not elicit a detailed history for rhinosinusitis. Protocol use increased this to 100%. First-line antibiotic therapy was used for only 49.4% of the patients before protocol use and for 68.5% after protocol use. Patients felt better after treatment 84.1% of the time; the Rhinosinusitis Disability Index could not measure improvement. CONCLUSION: Provider practice patterns were positively influenced by use of the protocol. SIGNIFICANCE: Clinical protocols should be developed to direct provider treatment practices. (Otolaryngol Head Neck Surg 2002;126:614-622.)
A cute rhinosinusitis is a common problem that affects an estimated 20 to 35 million Americans each year.1,2 The high prevalence of this disease accounts for a significant number of lost workdays and costs the health care system hundreds of millions of dollars annually. In 1992, an estimated $200 million was spent on prescription medications and an additional $2 billion was spent on over-the-counter treatments.3 Data from the 1991 National Ambulatory Medical Care Survey indiFrom the Department of Surgery Otolaryngology, University of Missouri Columbia. Reprint requests: William C. Kinney, MD, MHA, Department of Surgery Otolaryngology, University of Missouri-Columbia, One Hospital Drive, MA314, Columbia, MO 65212; e-mail, [email protected]. Copyright © 2002 by the American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. 0194-5998/2002/$35.00 ⫹ 0 23/1/125301 doi:10.1067/mhn.2002.125301 614
cated there were an estimated 11.5 million physician visits per year for conditions related to acute upper respiratory illness. Of these, 2 million visits were thought to be due to acute bacterial rhinosinusitis (ABRS).1 Acute rhinosinusitis has been clinically defined as a condition that results from inflammation of the mucous membranes, fluids, or underlying bones of the nasal passage and/or paranasal sinuses.4 Signs and symptoms associated with rhinosinusitis can vary with each presentation and underlying cause (eg, viral, allergic). Despite the high prevalence of rhinosinusitis, varying clinical presentations have made management difficult and controversial. Many caregivers are involved in the diagnosis of rhinosinusitis, including physician extenders, primary care physicians, otolaryngologists, allergists, and pulmonologists.4 The experience with and understanding of rhinosinusitis, as well as the tools available to aid in its diagnosis, vary among each of these specialties. Consequently, the same disease process can be treated in many different ways with resulting costs to the health care system that vary widely. Managed care organizations (MCOs) have grown in the US health care system as a result of rapid growth in health care costs. It is important to realize that managed care is no longer just a way to finance health care; it also represents a collection of responsibilities that includes patient education, promotion of wellness, utilization management, and provision of financial incentives to care providers.5 Central to the goal of managed care is the identification of ways to achieve both highquality and cost-effective health care. Efforts to realize these goals have focused on the use of clinical protocols to improve planning, coordination, communication, and evaluation of care.5 With successful implementation of a clinical protocol, resource use and costs should diminish. It is clear from the data that the evaluation and treatment of rhinosinusitis use a significant portion of health care dollars. Given the costs incurred by the
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health care system for rhinosinusitis, it is logical to consider the application of the principles of clinical protocol design and implementation to the evaluation and treatment of rhinosinusitis to achieve high-quality and cost-effective results. The development of ABRS occurs as part of a continuum of events. For example, the inciting event in the continuum can be either a viral infection or allergic rhinitis. Initial symptoms associated with either of these 2 events can be similar to those seen with ABRS. Treatment for the initial event can be quite different than that needed for ABRS, and determination of which treatment to use given similar symptoms can be difficult. To further compound the problem, some data suggest that spontaneous resolution of rhinosinusitis can occur, thus bringing into question the need for treatment altogether.6,7 In addition, the diagnosis and treatment of ABRS can be complicated because imperfect information is available to the clinician and there is variable overlap in disease processes. The cost to the health care system can vary based on the clinician’s approach to the problem. Example treatment protocols include a sinus radiographydirected strategy, the use of clinical criteria to guide treatment, initial symptomatic treatment (no antibiotic), and routine empirical use of antibiotics.3 The individual clinician can use any combination of treatment methods. Given the variability of treatment approach, it is reasonable to consider the use of a clinical protocol to focus the diagnosis and treatment of ABRS. Both the Rhinosinusitis Task Force of the American Academy of Otolaryngology Head and Neck Surgery (Task Force)8 and the Sinus and Allergy Health Partnership9 have published recommendations for the identification and treatment of bacterial rhinosinusitis. Although this information appears in publication, it is unlikely to find its way to the primary care provider without some help. Because primary care providers in the current managed care environment treat the majority of individuals with ABRS, it is in the best interest of otolaryngologists to help educate their primary care provider colleagues. Dissemination of expertise is more than altruistic. It will help to establish otolaryngology as the most appropriate referral source for the management of rhinosinusitis.
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The following is an evaluation of the current rhinosinusitis treatment practices of a group of primary care providers at the University of Missouri Columbia Health Sciences Center. Evaluation is followed by a discussion of the implementation of a treatment protocol developed from current evidence-based literature. Patients who are treated with use of the protocol are followed prospectively to determine how they were treated and to assess their response to treatment. MATERIALS AND METHODS Primary Care Provider Survey/Chart Review The Task Force outlined major and minor factors that can help determine whether a patient has ABRS8 (Fig 1, Table 1). Current provider practice patterns were examined by surveying primary care providers at the University of Missouri Columbia Health Sciences Center. The survey was designed to identify provider understanding about the symptoms of rhinosinusitis as they were outlined by the Task Force, preferred antibiotic choice, adjuvant therapy use, and the percentage of patients treated over the telephone versus in person. Surveys were sent to the current faculty within the departments of general internal medicine and family and community medicine at the University of Missouri Columbia. Also, charts were reviewed to determine whether provider documentation correlated with the self-reported practice patterns identified by the survey. One hundred charts were reviewed to determine which symptoms led to which diagnoses and what antibiotic and/or adjuvant treatment was initiated. Charts from both a general internal medicine clinic and a family and community medicine clinic were reviewed.
Data Sources Formulation of the clinical pathway for the diagnosis and treatment of adult ABRS was based on current evidencebased literature retrieved using a computer-aided search of the MEDLINE database from 1980 to July 2000. The search terms “sinusitis” and “treatment” were combined to generate a basic data set of relevant articles. The range of articles in the data set was subsequently narrowed by elimination of articles containing the following terms: “allergy,” “allergic,” “rhinitis,” “surgery,” “surgical,” “neoplasm,” “CT,” “MRI,” “immunosuppressed,” “immunosuppression,” “complication,” “complications,” “HIV,” “human immunodeficiency virus,” “fungus,” “fungal,” or “cystic fibrosis.” The remaining data set was further limited by excluding children under age 18, non-English articles, and articles not available in the Health Sciences Library of the University of Missouri Columbia School of Medicine. Pertinent articles identified from the
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A clinical diagnosis of rhinosinusitis can be made by the presence of 2 or more major factors, 1 major factor and 2 minor factors, or purulence in the nasal cavity on examination. The duration of symptoms should be longer than 10 days or worsen after 5 to 7 days. Major factors Facial pain/pressure Facial congestion/fullness Nasal obstruction/blockage Nasal discharge/postnasal drainage Hyposmia/anosmia
Minor factors Headache Fever Halitosis Fatigue Dental pain Cough Ear fullness Does the patient have 2 or more major factors or 1 major and 2 minor factors present with symptoms lasting longer 10 days (or worsening after 5 to 7 days)? YES
NO
Amoxicillin 500 mg PO TID ⫻ 10 days Or Bactrim DS PO BID ⫻ 10 days Add Oral decongestant Nasal saline irrigation Consider using Antihistamine (only if allergy symptoms present) Topical decongestant spray May also consider Amoxicillin 3.5 g/d divided TID ⫻ 10 days Augmentin 875 mg PO BID ⫻ 10 days Vantin 200 mg PO BID ⫻ 10 days Ceftin 250 mg PO BID ⫻ 10 days If -lactam allergic SMZ TMP DS BID ⫻ 10 days Doxycycline 100 mg TID ⫻ 10 days Azithromycin Z-pack Clarithromycin 500 mg BID ⫻ 10 days
Treat symptomatically Nasal saline irrigation Oral decongestant Antihistamine (only if allergy symptoms present) Reevaluate in 10 days
If the patient has had antibiotics in the last 4 to 6 weeks and symptoms are moderate to severe, consider using Augmentin 875 mg PO BID ⫻ 10 days Tequin 400 mg PO QD ⫻ 10 days Levaquin 500 mg PO QD ⫻ 10 days Avelox 400 mg PO QD ⫻ 10 days Combination: amoxicillin 3.5 g/d or clindamycin plus cefixime ⫻ 10 days Fig 1. Clinical pathway for the treatment of acute bacterial rhinosinusitis.
bibliography of the retrieved studies were also included where applicable. Additional data were obtained from a US government specific search for “sinusitis” using Northern Lights, a commercial World Wide Web search engine (http://www. northernlights.com). Relevant articles were selected based on their potential for contribution to the project objectives. Guidelines for use of the proper terms and definitions are based on the report of the Task Force.8
Protocol Use and Evaluation The completed protocol was introduced for use in the Fairview Internal Medicine Clinic at the University of Mis-
souri Columbia, a community-based internal medicine clinic. Subgroups of patients who called the triage line of the practice with symptoms of an upper respiratory tract infection were captured for protocol testing. The triage nurse was given a packet containing a copy of the protocol, a history sheet, and the follow-up survey. The triage nurse was instructed to ask a series of predetermined history questions used in the protocol to establish a clinical diagnosis of bacterial rhinosinusitis. The results were forwarded to the provider with a copy of the protocol for his or her review and to encourage its use in the treatment plan. The provider determined the treatment plan based on his or her practice preferences and the patient’s history. Each patient was mailed a copy of the
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Table 1. Comparison of symptom significance: primary care providers versus rhinosinusitis Task Force Primary care providers (% response) Symptom
Task Force assignment
Minor
Major
Not associated
Facial pain/pressure Facial congestion/fullness Nasal obstruction/blockage Nasal discharge/postnasal drainage Hyposmia/anosmia Headache Fever in combination Halitosis Fatigue Dental pain Cough Ear fullness Sneezing Watery eyes Fever alone
Major Major Major Major Major Minor Minor Minor Minor Minor Minor Minor Not associated Not associated Not associated
11.1 33.3 37 18.5 70.4 55.6 40.7 74.1 66.7 37 59.3 74.1 48.1 51.9 63
88.9 66.7 59.3 81.5 14.8 37 51.9 22.2 11.1 55.6 18.5 7.4 7.4 0 0
0 0 3.7 0 14.8 0 7.4 3.7 22.2 7.4 14.8 18.5 37 48.2 37
Rhinosinusitis Disability Index (RDI) and asked to fill out and return the survey after completion of the treatment plan. The RDI is a quality-of-life measurement tool that has been validated for use in patients with sinus disease.10 The survey is scored on a 0-to-4 scale (0, never; 1, almost never; 2, sometimes; 3, almost always; 4, always). An average of the score for each of the 30 standard questions (total score) and an average score for each of 3 subcategories (functional, emotional, and physical) were determined. A composite average score in each category was determined, along with a standard deviation, for comparison between groups and with historical controls taken from existing published results for acute rhinosinusitis using the RDI.11 Each survey was correlated with the history data through a simple numbering system. The principal investigator was blinded to the patient’s identification and demographic information. The survey results were used to help determine whether the patient’s symptoms improved with the prescribed treatment. In addition to the standard 30 questions in the survey, each patient was asked to state whether he or she completed the antibiotic regimen prescribed and whether he or she thought that the medicine made him or her feel better. RDI results for those who felt better were compared with RDI results of those who thought that they did not improve. In evaluating survey results, it is assumed that if patients improved, their survey score would be lower than that of those who did not improve, as well as lower than historical controls with acute rhinosinusitis. Given this assumption, all comparisons were completed using a 1-tailed Student t test with significance set at P ⬍ 0.05.
Research Approval The primary care survey, chart review, and protocol implementation and testing were approved by the Institutional Review Board of the University of Missouri Columbia.
RESULTS Literature Search Results Search of the MEDLINE database identified 218 articles that met the search criteria as outlined earlier. The abstracts of the articles were reviewed by the author for their relevance to the study objectives. Eighty-four relevant studies were available in the Health Sciences Library of the University of MissouriColumbia School of Medicine for individual assessment. The breakdown of article subject area is as follows: 30 for diagnosis and management; 6, adjuvant therapy; 9, microbiology; and 39, antimicrobial therapy. Three of the microbiology studies were excluded because they specifically covered chronic rhinosinusitis. Five of the antimicrobial selections were eliminated because they represented European studies using antibiotics not available for use in the United States. Clinical Pathway Development A proposed clinical protocol for the diagnosis and treatment of ABRS is presented in Figure 1. The pathway represents a modification of the Sinus and Allergy Health Partnership guidelines in that it includes the use of amoxicillin and sulfamethoxazole-trimethoprim (SMZ/TMP). The decision to add these 2 antibiotics as first-line treatments was made after a review of the current evidence-based data on the treatment of ABRS, which support the use of amoxicillin and SMZ/ TMP12-14 and is intended to focus on a cost-effec-
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tive approach that will provide high-quality care. The protocol is not intended to replace clinical decision-making on the part of the caregiver but rather to improve planning, coordination of care, and communication with patients and other caregivers. The appropriate length of therapy has not been determined using evidence-based research techniques. For the purpose of this clinical protocol, full-course treatment was considered to be a 10day course of antibiotic. Adjuvant therapy as outlined should continue until the symptoms resolve. Primary Care Provider Survey Fifty-five surveys were distributed to current faculty members of the departments of general internal medicine and family and community medicine at the University of Missouri Columbia. Twenty-nine surveys were returned, for a response rate of 52.7%. Two surveys were rejected because they were sent to nonclinical members of the Department of Family and Community Medicine. A comparison of the clinical symptoms recommended by the Task Force with the survey participants’ ratings of the symptoms is outlined in Table 1. A majority of survey participants correctly identified those symptoms listed as major symptoms of rhinosinusitis in every case except for hyposmia/anosmia. More than 80% of providers correctly identified facial pain/pressure and nasal discharge/postnasal drainage as major symptoms. More variability was seen in the interpretation of minor symptoms. Three of the 7 minor symptoms were correctly identified by more than two thirds of the respondents. Fever in combination with other symptoms, and dental pain, were incorrectly identified as major symptoms in more than half of the surveys. Participants were asked to approximate the number of Task Force recommended symptoms that they routinely ask about in their routine evaluation and management of ABRS. Only 40.7% inquired about more than three fourths of the symptoms, but at least 77.8% inquired about half or more of the symptoms. Patients with ABRS were treated over the telephone 18.2% of the time. The participants estimated that they treated only 58% of patients with antibiotics at the initial visit. Table 2 lists the percentage of adjuvant therapies
Table 2. Adjuvant therapy use by providers, self-reported from provider survey Adjuvant therapy
Provider use (%)
Decongestant nasal spray Saline nasal spray Steroid nasal spray Oral decongestant Antihistamine Antihistamine with decongestant Oral steroids
25.1 33.6 23.0 5.7 5.7 20.2 0.7
used by respondents. Adjuvants are used in fewer than one third of the patients at the initial visit. Many providers indicated that they discuss the use of over-the-counter adjuvants with their patients but do not routinely prescribe them for treatment. Primary Care Chart Review Two community-based clinics, one each from the departments of general internal medicine and family and community medicine, were targeted for an outpatient record review of the evaluation and management of ABRS. Fifty records were identified from each clinic, for a total of 100 records. Seventeen charts were eliminated because patients were younger than 18 years or had symptoms for longer than 4 weeks. Final review was completed on 83 charts looking specifically for what symptoms were documented in support of a diagnosis of ABRS and what treatment was prescribed. Table 3 lists the percentage of time that the provider documented each symptom in the chart, either positive or negative. The range of symptoms recommended by the Task Force that were documented in support of a diagnosis of ABRS varied from 1 to 7 (mean 3.6). Providers rarely documented hyposmia/anosmia, fatigue, dental pain, or ear fullness as a supporting symptom. Nasal discharge (71.1%) was the most commonly documented symptom, followed by cough (63.9%) and facial pain/pressure (59.9%). Table 4 lists the number and types of adjuvant therapies prescribed by the providers. Table 5 lists the choice of antibiotic and the relative prevalence of each choice identified from chart review. Overall, amoxicillin and SMZ/TMP were prescribed approximately 50% of the time.
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Table 3. Percentage of time each symptom was documented, whether positive or negative, in the evaluation and management of patients with acute bacterial rhinosinusitis in a primary care setting as determined from chart review Symptom
Table 5. Choice and prevalence of antibiotic before and after protocol use No. of times prescribed (%)
Reported (%) Antibiotic
Major symptom Facial pain/pressure Facial congestion/fullness Nasal obstruction/blockage Nasal discharge/postnasal drainage Hyposmia/anosmia Minor symptom Headache Fever in combination Halitosis Fatigue Dental pain Cough Ear fullness
59.0 21.7 38.6 71.1 0.0 36.1 34.9 0.0 9.6 7.2 63.9 4.8
Table 4. Adjuvant therapy use by primary care providers identified on chart review and after protocol implementation
Amoxicillin Erythromycin Clarithromycin (Biaxin) Azithromycin (Zithromax) Amoxicillin/clavulanate (Augmentin) SMZ/TMP (Bactrim) Gatifloxacin (Tequin) Ciprofloxacin (Cipro) Cefuroxime axetil (Ceftin) Doxycycline Cephalexin (Keflex) Erythromycin-sulfamethoxazole Moxifloxacin (Avelox) Levofloxacin (Levaquin) Cefpodoxime proxetil (Vantin) None/Not listed
Chart review (n ⴝ 83)
Protocol use (n ⴝ 92)
16 (19.3) 2 (2.4) 7 (8.4) 12 (14.6) 6 (7.2)
31 (33.7) 2 (2.2) 3 (3.3) 7 (7.6) 3 (3.3)
25 (30.1) 1 (1.2) 1 (1.2) 1 (1.2) 2 (2.4) 1 (1.2) 1 (1.2)
32 (34.8) 0 (0) 0 (0) 0 (0) 1 (1.1) 0 (0) 0 (0)
0 (0) 0 (0) 0 (0) 6 (7.2)
1 (1.1) 1 (1.1) 1 (1.1) 10 (10.9)
No. of times prescribed (%)
Adjuvant therapy
Antihistamine Antihistamine with decongestant Oral decongestant Nasal steroid spray Saline nasal spray Topical decongestant spray Oral steroids
Chart review (n ⴝ 83)
Protocol use (n ⴝ 92)
6 (7.2) 2 (2.4)
9 (9.8) 4 (4.3)
17 (20.5) 9 (10.8) 9 (10.8) 8 (9.6)
12 (13.0) 4 (4.3) 30 (36.6) 15 (16.3)
1 (1.2)
1 (1.1)
Protocol Evaluation Data from the RDI were collected and correlated with the history form collected from the triage nurse. Ninety-two patients were treated over the telephone at the Fairview Internal Medicine Clinic at the University of Missouri Columbia from October 2000 to June 2001. All 92 patients were asked the complete set of history questions as outlined by the protocol. All patients met the criteria for ABRS based on the major and minor symptoms suggested by the Task Force. The average number of positive major and minor symptoms identified was 4.5 (range 2 to 5) and 4.6
(range 2 to 7), respectively. Although the Task Force recommendations do not specify duration of symptoms, symptoms lasting less than 5 days are likely to represent the initial stages of a viral infection that may be self-limited and does not require antibiotic treatment. All of the 92 patients met the criteria based on the symptom list but 11 had a symptom duration of less than 5 days. All except 1 of the 11 patients was treated with antibiotics. The antibiotics prescribed are listed in Table 5. Only 7 patients were treated with antibiotics not recommended in the protocol. The choice of antibiotic was not identified in 9 patients. Only 1 patient was not treated with antibiotics. Four patients refused the antibiotic initially prescribed by the provider and requested SMZ/TMP (n ⫽ 2), azithromycin (n ⫽ 1), or clarithromycin (n ⫽ 1). Seven patients who subjectively did not get better received amoxicillin (n ⫽ 3), SMZ/TMP (n ⫽ 2), azithromycin (n ⫽ 1), or no antibiotic (n ⫽ 1). Adjuvant treatment use with the protocol is summarized in Table 4. RDI surveys were received from 44 patients, for a response rate of 47.8%. The survey was scored
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Table 6. Rhinosinusitis Disability Index results
Total score Functional subscore Emotional subscore Physical subscore
All patients
Patients subjectively improved
Patients subjectively not improved
Historical controls11
1.48 (0.91) 1.50 (0.94) 1.25 (0.96) 1.69 (0.95)
1.42 (0.91) 1.42 (0.93) 1.22 (0.97) 1.59 (0.92)
1.85 (0.88) 1.89 (0.94) 1.44 (0.96) 2.19 (0.98)
1.18 (0.89) 1.32 (0.86) 0.86 (0.89) 1.35 (0.99)
Values given as ⫾ (SD) (n ⫽ 44).
in 4 parts with a total score and functional, emotional, and physical subscores. Two additional questions were included in the RDI to determine whether patients completed the entire course of prescribed medication and whether they thought that the medicine made them feel better. All except 3 of the 44 patients who responded completed the medication as prescribed. Seven of the 44 patients thought that they did not get better. Only 1 of the 7 who indicated no improvement did not complete the full course of medication. Results of the RDI are listed in Table 6; they are broken down into the results of all patients compared with historical controls and the results of those who stated they did improve compared with those who stated they did not. There was no statistical significance between any of the comparison groups (all surveyed vs historical controls, those who felt better vs those who did not feel better, and those who felt better vs historical controls). DISCUSSION Although medicine has evolved into a detailed science, both the practice of medicine and the application of medical principles remains an art. Evaluation and treatment center on the traditional physician-patient relationship with an exchange of information and knowledge between the caregiver and the patient. Rapid advancement on the science side of medicine has resulted in simple, modern-day treatments for problems that were once uniformly fatal. Rapid advancement has also created new possibilities for treatment that are based on sound principles at the individual level but that are lacking evidence-based proof of overall effectiveness. In the diagnosis and treatment of ABRS, a number of diagnostic tools (nasal endoscopy, paranasal sinus computed tomography) and a number of treatment
tools (antibiotics) are available. Each tool has been successful in individual circumstances, but its overall value across groups in achieving an effective and efficient outcome has not been proved. Rapidly increasing health care costs have been attributed to inefficiencies in the way health care is provided. Managed care has evolved as a way to regain control over these increasing costs. As a result, MCOs are beginning to direct the way health care is provided at the individual practitioner level. Clinical protocols are now recognized as a tool for MCOs to direct care cost effectively and efficiently. They are most usefully applied to conditions with high prevalence and high dollar costs. Because of the inefficiencies surrounding both the diagnosis and the treatment of ABRS, it is an ideal condition for clinical protocol use. From a business standpoint, the concept of clinical protocol utilization in modern health care makes sense and should probably be expanded. From a health care provider standpoint, clinical protocols can represent a threat to individual autonomy. This perceived threat has resulted in underuse by health care providers. Unfortunately, health care costs are continuing to rise and MCOs are faced with the burden of curtailing costs yet providing quality care. The clinical protocol outlined for the treatment of ABRS has been designed to achieve the desired results while allowing for some autonomy by the care provider. The main purpose of the protocol is to educate the care provider in how to recognize and treat ABRS in a cost-effective manner. The protocol succeeded in ensuring that all symptoms related to sinonasal disease were evaluated in each patient. In contrast, the chart review and provider survey showed a poor understanding of the importance of certain
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symptoms and a general lack of inquiry into the different symptoms. The results also show that providers’ prescribing habits can be directed through the use of a protocol. Despite a number of published reports suggesting that amoxicillin and SMZ/TMP are adequate for the treatment of uncomplicated rhinosinusitis, the chart review identified that only 49.4% of patients were treated with either of these 2 antibiotics. After implementation of the protocol, the number of patients treated with either of these 2 first-line therapies jumped to 68.5%. The protocol also successfully eliminated the use of inappropriate antibiotics such as cephalexin that do not cover the 3 common bacteria associated with ABRS. The RDI results did not provide any statistical significance in terms of measuring symptom improvement. In fact, the raw scores for all patients asked to fill out the survey after completion of treatment were actually worse than historical controls of patients with known sinonasal disease. These results suggest that use of the RDI as a static measure of patient symptoms is inappropriate and serial measurements are probably needed to measure differences. In this particular case, it is likely that asking individuals to try to distinguish current symptoms from previous symptoms introduces significant recall bias. Despite the inability to measure improvement with the RDI, this project found that 84.1% of the individuals who responded to the survey thought that they were better after completing the antibiotic course. These results suggest a number of possibilities, including that a majority of patients did improve but the RDI could not measure improvement or that, regardless of treatment, ABRS is a self-limited disease and pharmaceutical treatment offers only placebo effect. The subjective improvement reported by the patients also suggests that amoxicillin and SMZ/ TMP may be just as good as the more expensive antibiotics, a concept suggested by an number of recognized authorities, including the Agency for Healthcare Research and Quality.3 Any clinical protocol must undergo testing before it can be considered a standard of care. Because health care is not a static science, clinical protocols must also be continually reviewed and updated to remain effective. This work is meant to outline a clinical protocol for the diagnosis and
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treatment of ABRS using evidence-based data generated from the literature. Before full implementation, the protocol must be tested to show whether it can accomplish the goal of achieving a quality result while remaining cost-effective. No significant conclusion can be made at this point in the evaluation process. CONCLUSION Rhinosinusitis represents a significant medical problem worldwide and consumes a large portion of health care dollars. Many forms of evaluation and management of adult ABRS exist, and the approach to treatment can vary among clinicians. The value of clinical protocol utilization to direct treatment in a cost-effective manner using evidence-based scientific literature has been shown. Clinical protocols for the diagnosis and treatment of ABRS may focus care to achieve a quality result in a cost-effective manner. Before implementation, the validity of the clinical protocol must be assessed in a prospective study. The author acknowledges the assistance of Richard Burns, MD, Clinic Director of the Fairview Internal Medicine Clinic, for his assistance in evaluation of the protocol and Pam Fuller for her assistance in collecting the history information. In addition, the following Fairview Internal Medicine Clinic physicians are recognized for their willingness to use the protocol to treat their patients: Richard Burns, Sharon Carmignani, Thomas Cheek, James Koller, and Kristen HahnCover. The author is also grateful to Martha Bowes for manuscript preparation. REFERENCES
1. Gwaltney JM. Acute community-acquired sinusitis. Clin Infect Dis 1996;23:1209-25. 2. Am Acad Otolaryngol Head Neck Surg Bull 1999;18:910. 3. Agency for Health Care Policy and Research. Diagnosis and treatment of acute bacterial rhinosinusitis: summary, evidence report/technology assessment, No. 9, March 1999. Rockville, MD: Agency for Health Care Policy and Research. http://www.ahrq.gov/clinic/sinussum.htm. 4. Lanza DC, Kennedy DW. Adult rhinosinusitis defined. Otolaryngol Head Neck Surg 1997;117:S1-7. 5. Fox PD. An overview of managed care. In: Kongstvedt PR, ed. The managed health care handbook. 3rd ed. Gaithersburg, MD: Aspen Publishers; 1996. p. 3-15. 6. Poole MD. Antimicrobial therapy for sinusitis. Otolaryngol Clin North Am 1997;30:331-9. 7. Dolhman AW. Role of antibiotic and non-antibiotic therapy in the treatment of sinusitis with an allergic basis. Clin Exp Allergy 1994;24:1094-7.
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8. Anon JB. Report of the Rhinosinusitis Task Force Committee Meeting. Otolaryngol Head Neck Surg 1997;117: S1-S68. 9. Sinus and Allergy Health Partnership. Antimicrobial treatment guidelines for acute bacterial rhinosinusitis. Otolaryngol Head Neck Surg 2000;123(suppl 2):S1-S32. 10. Benninger MS, Senior BA. The development of the Rhinosinusitis Disability Index. Arch Otolaryngol Head Neck Surg 1997;123:1175-9. 11. Senior SA, Glaze C, Benninger MS. Use of the Rhinosinusitis Disability Index (RDI) in rhinologic disease. Am J Rhinol 2001;15:15-20.
12. de Farranti SD, Ioannidis JPA, Lau J, et al. Are amoxicillin and folate inhibitors as effective as other antibiotics for acute sinusitis? a meta-analysis. Br Med J 1998;317: 632-63. 13. de Bock GH, Dekker FW, Stolk J, et al. Antimicrobial treatment in acute maxillary sinusitis: a meta-analysis. J Clin Epidemiol 1997;50:881-90. 14. Benninger MS, Sedory-Holzer SE, Lau J. Diagnosis and treatment of uncomplicated acute bacterial rhinosinusitis: summary of the Agency for Health Care Policy and Research evidence-based report. Otolaryngol Head Neck Surg 2000;122:1-7.
American Academy of Otolaryngic Allergy Course and Meeting Schedule for 2002 Basic Course in Otolaryngic Allergy, Summer 2002, exact dates and location to be announced. Annual Meeting, Sept 19-21, 2002, in San Diego, CA. Advanced Course in Otolaryngic Allergy and Immunology, Dec 5-8, 2002, at the Resort at Squaw Creek in Lake Tahoe, CA. For additional information, contact Laura Chaplin, Meetings and Membership Coordinator, American Academy of Otolaryngic Allergy (AAOA), 1990 M Street, NW, Suite 680, Washington, DC 20036; tel, 202-955-5010 ext 106; fax, 202-955-5016; www.aaoaf.org.
MD, MHA,
Columbia, Missouri
OBJECTIVE: Sinus infections are common and represent a high cost to the health care industry. Clinical protocols can be used to develop cost-effective treatment strategies. Our objective was to show that a protocol for rhinosinusitis can change provider practice patterns in primary care. STUDY DESIGN AND SETTING: We used a literature search, survey of primary caregivers, and chart review from an academic health center to define and document current patterns. A protocol was developed and evaluated using the Rhinosinusitis Disability Index. RESULTS: Survey and chart review identified that primary caregivers do not elicit a detailed history for rhinosinusitis. Protocol use increased this to 100%. First-line antibiotic therapy was used for only 49.4% of the patients before protocol use and for 68.5% after protocol use. Patients felt better after treatment 84.1% of the time; the Rhinosinusitis Disability Index could not measure improvement. CONCLUSION: Provider practice patterns were positively influenced by use of the protocol. SIGNIFICANCE: Clinical protocols should be developed to direct provider treatment practices. (Otolaryngol Head Neck Surg 2002;126:614-622.)
A cute rhinosinusitis is a common problem that affects an estimated 20 to 35 million Americans each year.1,2 The high prevalence of this disease accounts for a significant number of lost workdays and costs the health care system hundreds of millions of dollars annually. In 1992, an estimated $200 million was spent on prescription medications and an additional $2 billion was spent on over-the-counter treatments.3 Data from the 1991 National Ambulatory Medical Care Survey indiFrom the Department of Surgery Otolaryngology, University of Missouri Columbia. Reprint requests: William C. Kinney, MD, MHA, Department of Surgery Otolaryngology, University of Missouri-Columbia, One Hospital Drive, MA314, Columbia, MO 65212; e-mail, [email protected]. Copyright © 2002 by the American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. 0194-5998/2002/$35.00 ⫹ 0 23/1/125301 doi:10.1067/mhn.2002.125301 614
cated there were an estimated 11.5 million physician visits per year for conditions related to acute upper respiratory illness. Of these, 2 million visits were thought to be due to acute bacterial rhinosinusitis (ABRS).1 Acute rhinosinusitis has been clinically defined as a condition that results from inflammation of the mucous membranes, fluids, or underlying bones of the nasal passage and/or paranasal sinuses.4 Signs and symptoms associated with rhinosinusitis can vary with each presentation and underlying cause (eg, viral, allergic). Despite the high prevalence of rhinosinusitis, varying clinical presentations have made management difficult and controversial. Many caregivers are involved in the diagnosis of rhinosinusitis, including physician extenders, primary care physicians, otolaryngologists, allergists, and pulmonologists.4 The experience with and understanding of rhinosinusitis, as well as the tools available to aid in its diagnosis, vary among each of these specialties. Consequently, the same disease process can be treated in many different ways with resulting costs to the health care system that vary widely. Managed care organizations (MCOs) have grown in the US health care system as a result of rapid growth in health care costs. It is important to realize that managed care is no longer just a way to finance health care; it also represents a collection of responsibilities that includes patient education, promotion of wellness, utilization management, and provision of financial incentives to care providers.5 Central to the goal of managed care is the identification of ways to achieve both highquality and cost-effective health care. Efforts to realize these goals have focused on the use of clinical protocols to improve planning, coordination, communication, and evaluation of care.5 With successful implementation of a clinical protocol, resource use and costs should diminish. It is clear from the data that the evaluation and treatment of rhinosinusitis use a significant portion of health care dollars. Given the costs incurred by the
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health care system for rhinosinusitis, it is logical to consider the application of the principles of clinical protocol design and implementation to the evaluation and treatment of rhinosinusitis to achieve high-quality and cost-effective results. The development of ABRS occurs as part of a continuum of events. For example, the inciting event in the continuum can be either a viral infection or allergic rhinitis. Initial symptoms associated with either of these 2 events can be similar to those seen with ABRS. Treatment for the initial event can be quite different than that needed for ABRS, and determination of which treatment to use given similar symptoms can be difficult. To further compound the problem, some data suggest that spontaneous resolution of rhinosinusitis can occur, thus bringing into question the need for treatment altogether.6,7 In addition, the diagnosis and treatment of ABRS can be complicated because imperfect information is available to the clinician and there is variable overlap in disease processes. The cost to the health care system can vary based on the clinician’s approach to the problem. Example treatment protocols include a sinus radiographydirected strategy, the use of clinical criteria to guide treatment, initial symptomatic treatment (no antibiotic), and routine empirical use of antibiotics.3 The individual clinician can use any combination of treatment methods. Given the variability of treatment approach, it is reasonable to consider the use of a clinical protocol to focus the diagnosis and treatment of ABRS. Both the Rhinosinusitis Task Force of the American Academy of Otolaryngology Head and Neck Surgery (Task Force)8 and the Sinus and Allergy Health Partnership9 have published recommendations for the identification and treatment of bacterial rhinosinusitis. Although this information appears in publication, it is unlikely to find its way to the primary care provider without some help. Because primary care providers in the current managed care environment treat the majority of individuals with ABRS, it is in the best interest of otolaryngologists to help educate their primary care provider colleagues. Dissemination of expertise is more than altruistic. It will help to establish otolaryngology as the most appropriate referral source for the management of rhinosinusitis.
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The following is an evaluation of the current rhinosinusitis treatment practices of a group of primary care providers at the University of Missouri Columbia Health Sciences Center. Evaluation is followed by a discussion of the implementation of a treatment protocol developed from current evidence-based literature. Patients who are treated with use of the protocol are followed prospectively to determine how they were treated and to assess their response to treatment. MATERIALS AND METHODS Primary Care Provider Survey/Chart Review The Task Force outlined major and minor factors that can help determine whether a patient has ABRS8 (Fig 1, Table 1). Current provider practice patterns were examined by surveying primary care providers at the University of Missouri Columbia Health Sciences Center. The survey was designed to identify provider understanding about the symptoms of rhinosinusitis as they were outlined by the Task Force, preferred antibiotic choice, adjuvant therapy use, and the percentage of patients treated over the telephone versus in person. Surveys were sent to the current faculty within the departments of general internal medicine and family and community medicine at the University of Missouri Columbia. Also, charts were reviewed to determine whether provider documentation correlated with the self-reported practice patterns identified by the survey. One hundred charts were reviewed to determine which symptoms led to which diagnoses and what antibiotic and/or adjuvant treatment was initiated. Charts from both a general internal medicine clinic and a family and community medicine clinic were reviewed.
Data Sources Formulation of the clinical pathway for the diagnosis and treatment of adult ABRS was based on current evidencebased literature retrieved using a computer-aided search of the MEDLINE database from 1980 to July 2000. The search terms “sinusitis” and “treatment” were combined to generate a basic data set of relevant articles. The range of articles in the data set was subsequently narrowed by elimination of articles containing the following terms: “allergy,” “allergic,” “rhinitis,” “surgery,” “surgical,” “neoplasm,” “CT,” “MRI,” “immunosuppressed,” “immunosuppression,” “complication,” “complications,” “HIV,” “human immunodeficiency virus,” “fungus,” “fungal,” or “cystic fibrosis.” The remaining data set was further limited by excluding children under age 18, non-English articles, and articles not available in the Health Sciences Library of the University of Missouri Columbia School of Medicine. Pertinent articles identified from the
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A clinical diagnosis of rhinosinusitis can be made by the presence of 2 or more major factors, 1 major factor and 2 minor factors, or purulence in the nasal cavity on examination. The duration of symptoms should be longer than 10 days or worsen after 5 to 7 days. Major factors Facial pain/pressure Facial congestion/fullness Nasal obstruction/blockage Nasal discharge/postnasal drainage Hyposmia/anosmia
Minor factors Headache Fever Halitosis Fatigue Dental pain Cough Ear fullness Does the patient have 2 or more major factors or 1 major and 2 minor factors present with symptoms lasting longer 10 days (or worsening after 5 to 7 days)? YES
NO
Amoxicillin 500 mg PO TID ⫻ 10 days Or Bactrim DS PO BID ⫻ 10 days Add Oral decongestant Nasal saline irrigation Consider using Antihistamine (only if allergy symptoms present) Topical decongestant spray May also consider Amoxicillin 3.5 g/d divided TID ⫻ 10 days Augmentin 875 mg PO BID ⫻ 10 days Vantin 200 mg PO BID ⫻ 10 days Ceftin 250 mg PO BID ⫻ 10 days If -lactam allergic SMZ TMP DS BID ⫻ 10 days Doxycycline 100 mg TID ⫻ 10 days Azithromycin Z-pack Clarithromycin 500 mg BID ⫻ 10 days
Treat symptomatically Nasal saline irrigation Oral decongestant Antihistamine (only if allergy symptoms present) Reevaluate in 10 days
If the patient has had antibiotics in the last 4 to 6 weeks and symptoms are moderate to severe, consider using Augmentin 875 mg PO BID ⫻ 10 days Tequin 400 mg PO QD ⫻ 10 days Levaquin 500 mg PO QD ⫻ 10 days Avelox 400 mg PO QD ⫻ 10 days Combination: amoxicillin 3.5 g/d or clindamycin plus cefixime ⫻ 10 days Fig 1. Clinical pathway for the treatment of acute bacterial rhinosinusitis.
bibliography of the retrieved studies were also included where applicable. Additional data were obtained from a US government specific search for “sinusitis” using Northern Lights, a commercial World Wide Web search engine (http://www. northernlights.com). Relevant articles were selected based on their potential for contribution to the project objectives. Guidelines for use of the proper terms and definitions are based on the report of the Task Force.8
Protocol Use and Evaluation The completed protocol was introduced for use in the Fairview Internal Medicine Clinic at the University of Mis-
souri Columbia, a community-based internal medicine clinic. Subgroups of patients who called the triage line of the practice with symptoms of an upper respiratory tract infection were captured for protocol testing. The triage nurse was given a packet containing a copy of the protocol, a history sheet, and the follow-up survey. The triage nurse was instructed to ask a series of predetermined history questions used in the protocol to establish a clinical diagnosis of bacterial rhinosinusitis. The results were forwarded to the provider with a copy of the protocol for his or her review and to encourage its use in the treatment plan. The provider determined the treatment plan based on his or her practice preferences and the patient’s history. Each patient was mailed a copy of the
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Table 1. Comparison of symptom significance: primary care providers versus rhinosinusitis Task Force Primary care providers (% response) Symptom
Task Force assignment
Minor
Major
Not associated
Facial pain/pressure Facial congestion/fullness Nasal obstruction/blockage Nasal discharge/postnasal drainage Hyposmia/anosmia Headache Fever in combination Halitosis Fatigue Dental pain Cough Ear fullness Sneezing Watery eyes Fever alone
Major Major Major Major Major Minor Minor Minor Minor Minor Minor Minor Not associated Not associated Not associated
11.1 33.3 37 18.5 70.4 55.6 40.7 74.1 66.7 37 59.3 74.1 48.1 51.9 63
88.9 66.7 59.3 81.5 14.8 37 51.9 22.2 11.1 55.6 18.5 7.4 7.4 0 0
0 0 3.7 0 14.8 0 7.4 3.7 22.2 7.4 14.8 18.5 37 48.2 37
Rhinosinusitis Disability Index (RDI) and asked to fill out and return the survey after completion of the treatment plan. The RDI is a quality-of-life measurement tool that has been validated for use in patients with sinus disease.10 The survey is scored on a 0-to-4 scale (0, never; 1, almost never; 2, sometimes; 3, almost always; 4, always). An average of the score for each of the 30 standard questions (total score) and an average score for each of 3 subcategories (functional, emotional, and physical) were determined. A composite average score in each category was determined, along with a standard deviation, for comparison between groups and with historical controls taken from existing published results for acute rhinosinusitis using the RDI.11 Each survey was correlated with the history data through a simple numbering system. The principal investigator was blinded to the patient’s identification and demographic information. The survey results were used to help determine whether the patient’s symptoms improved with the prescribed treatment. In addition to the standard 30 questions in the survey, each patient was asked to state whether he or she completed the antibiotic regimen prescribed and whether he or she thought that the medicine made him or her feel better. RDI results for those who felt better were compared with RDI results of those who thought that they did not improve. In evaluating survey results, it is assumed that if patients improved, their survey score would be lower than that of those who did not improve, as well as lower than historical controls with acute rhinosinusitis. Given this assumption, all comparisons were completed using a 1-tailed Student t test with significance set at P ⬍ 0.05.
Research Approval The primary care survey, chart review, and protocol implementation and testing were approved by the Institutional Review Board of the University of Missouri Columbia.
RESULTS Literature Search Results Search of the MEDLINE database identified 218 articles that met the search criteria as outlined earlier. The abstracts of the articles were reviewed by the author for their relevance to the study objectives. Eighty-four relevant studies were available in the Health Sciences Library of the University of MissouriColumbia School of Medicine for individual assessment. The breakdown of article subject area is as follows: 30 for diagnosis and management; 6, adjuvant therapy; 9, microbiology; and 39, antimicrobial therapy. Three of the microbiology studies were excluded because they specifically covered chronic rhinosinusitis. Five of the antimicrobial selections were eliminated because they represented European studies using antibiotics not available for use in the United States. Clinical Pathway Development A proposed clinical protocol for the diagnosis and treatment of ABRS is presented in Figure 1. The pathway represents a modification of the Sinus and Allergy Health Partnership guidelines in that it includes the use of amoxicillin and sulfamethoxazole-trimethoprim (SMZ/TMP). The decision to add these 2 antibiotics as first-line treatments was made after a review of the current evidence-based data on the treatment of ABRS, which support the use of amoxicillin and SMZ/ TMP12-14 and is intended to focus on a cost-effec-
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tive approach that will provide high-quality care. The protocol is not intended to replace clinical decision-making on the part of the caregiver but rather to improve planning, coordination of care, and communication with patients and other caregivers. The appropriate length of therapy has not been determined using evidence-based research techniques. For the purpose of this clinical protocol, full-course treatment was considered to be a 10day course of antibiotic. Adjuvant therapy as outlined should continue until the symptoms resolve. Primary Care Provider Survey Fifty-five surveys were distributed to current faculty members of the departments of general internal medicine and family and community medicine at the University of Missouri Columbia. Twenty-nine surveys were returned, for a response rate of 52.7%. Two surveys were rejected because they were sent to nonclinical members of the Department of Family and Community Medicine. A comparison of the clinical symptoms recommended by the Task Force with the survey participants’ ratings of the symptoms is outlined in Table 1. A majority of survey participants correctly identified those symptoms listed as major symptoms of rhinosinusitis in every case except for hyposmia/anosmia. More than 80% of providers correctly identified facial pain/pressure and nasal discharge/postnasal drainage as major symptoms. More variability was seen in the interpretation of minor symptoms. Three of the 7 minor symptoms were correctly identified by more than two thirds of the respondents. Fever in combination with other symptoms, and dental pain, were incorrectly identified as major symptoms in more than half of the surveys. Participants were asked to approximate the number of Task Force recommended symptoms that they routinely ask about in their routine evaluation and management of ABRS. Only 40.7% inquired about more than three fourths of the symptoms, but at least 77.8% inquired about half or more of the symptoms. Patients with ABRS were treated over the telephone 18.2% of the time. The participants estimated that they treated only 58% of patients with antibiotics at the initial visit. Table 2 lists the percentage of adjuvant therapies
Table 2. Adjuvant therapy use by providers, self-reported from provider survey Adjuvant therapy
Provider use (%)
Decongestant nasal spray Saline nasal spray Steroid nasal spray Oral decongestant Antihistamine Antihistamine with decongestant Oral steroids
25.1 33.6 23.0 5.7 5.7 20.2 0.7
used by respondents. Adjuvants are used in fewer than one third of the patients at the initial visit. Many providers indicated that they discuss the use of over-the-counter adjuvants with their patients but do not routinely prescribe them for treatment. Primary Care Chart Review Two community-based clinics, one each from the departments of general internal medicine and family and community medicine, were targeted for an outpatient record review of the evaluation and management of ABRS. Fifty records were identified from each clinic, for a total of 100 records. Seventeen charts were eliminated because patients were younger than 18 years or had symptoms for longer than 4 weeks. Final review was completed on 83 charts looking specifically for what symptoms were documented in support of a diagnosis of ABRS and what treatment was prescribed. Table 3 lists the percentage of time that the provider documented each symptom in the chart, either positive or negative. The range of symptoms recommended by the Task Force that were documented in support of a diagnosis of ABRS varied from 1 to 7 (mean 3.6). Providers rarely documented hyposmia/anosmia, fatigue, dental pain, or ear fullness as a supporting symptom. Nasal discharge (71.1%) was the most commonly documented symptom, followed by cough (63.9%) and facial pain/pressure (59.9%). Table 4 lists the number and types of adjuvant therapies prescribed by the providers. Table 5 lists the choice of antibiotic and the relative prevalence of each choice identified from chart review. Overall, amoxicillin and SMZ/TMP were prescribed approximately 50% of the time.
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Table 3. Percentage of time each symptom was documented, whether positive or negative, in the evaluation and management of patients with acute bacterial rhinosinusitis in a primary care setting as determined from chart review Symptom
Table 5. Choice and prevalence of antibiotic before and after protocol use No. of times prescribed (%)
Reported (%) Antibiotic
Major symptom Facial pain/pressure Facial congestion/fullness Nasal obstruction/blockage Nasal discharge/postnasal drainage Hyposmia/anosmia Minor symptom Headache Fever in combination Halitosis Fatigue Dental pain Cough Ear fullness
59.0 21.7 38.6 71.1 0.0 36.1 34.9 0.0 9.6 7.2 63.9 4.8
Table 4. Adjuvant therapy use by primary care providers identified on chart review and after protocol implementation
Amoxicillin Erythromycin Clarithromycin (Biaxin) Azithromycin (Zithromax) Amoxicillin/clavulanate (Augmentin) SMZ/TMP (Bactrim) Gatifloxacin (Tequin) Ciprofloxacin (Cipro) Cefuroxime axetil (Ceftin) Doxycycline Cephalexin (Keflex) Erythromycin-sulfamethoxazole Moxifloxacin (Avelox) Levofloxacin (Levaquin) Cefpodoxime proxetil (Vantin) None/Not listed
Chart review (n ⴝ 83)
Protocol use (n ⴝ 92)
16 (19.3) 2 (2.4) 7 (8.4) 12 (14.6) 6 (7.2)
31 (33.7) 2 (2.2) 3 (3.3) 7 (7.6) 3 (3.3)
25 (30.1) 1 (1.2) 1 (1.2) 1 (1.2) 2 (2.4) 1 (1.2) 1 (1.2)
32 (34.8) 0 (0) 0 (0) 0 (0) 1 (1.1) 0 (0) 0 (0)
0 (0) 0 (0) 0 (0) 6 (7.2)
1 (1.1) 1 (1.1) 1 (1.1) 10 (10.9)
No. of times prescribed (%)
Adjuvant therapy
Antihistamine Antihistamine with decongestant Oral decongestant Nasal steroid spray Saline nasal spray Topical decongestant spray Oral steroids
Chart review (n ⴝ 83)
Protocol use (n ⴝ 92)
6 (7.2) 2 (2.4)
9 (9.8) 4 (4.3)
17 (20.5) 9 (10.8) 9 (10.8) 8 (9.6)
12 (13.0) 4 (4.3) 30 (36.6) 15 (16.3)
1 (1.2)
1 (1.1)
Protocol Evaluation Data from the RDI were collected and correlated with the history form collected from the triage nurse. Ninety-two patients were treated over the telephone at the Fairview Internal Medicine Clinic at the University of Missouri Columbia from October 2000 to June 2001. All 92 patients were asked the complete set of history questions as outlined by the protocol. All patients met the criteria for ABRS based on the major and minor symptoms suggested by the Task Force. The average number of positive major and minor symptoms identified was 4.5 (range 2 to 5) and 4.6
(range 2 to 7), respectively. Although the Task Force recommendations do not specify duration of symptoms, symptoms lasting less than 5 days are likely to represent the initial stages of a viral infection that may be self-limited and does not require antibiotic treatment. All of the 92 patients met the criteria based on the symptom list but 11 had a symptom duration of less than 5 days. All except 1 of the 11 patients was treated with antibiotics. The antibiotics prescribed are listed in Table 5. Only 7 patients were treated with antibiotics not recommended in the protocol. The choice of antibiotic was not identified in 9 patients. Only 1 patient was not treated with antibiotics. Four patients refused the antibiotic initially prescribed by the provider and requested SMZ/TMP (n ⫽ 2), azithromycin (n ⫽ 1), or clarithromycin (n ⫽ 1). Seven patients who subjectively did not get better received amoxicillin (n ⫽ 3), SMZ/TMP (n ⫽ 2), azithromycin (n ⫽ 1), or no antibiotic (n ⫽ 1). Adjuvant treatment use with the protocol is summarized in Table 4. RDI surveys were received from 44 patients, for a response rate of 47.8%. The survey was scored
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Table 6. Rhinosinusitis Disability Index results
Total score Functional subscore Emotional subscore Physical subscore
All patients
Patients subjectively improved
Patients subjectively not improved
Historical controls11
1.48 (0.91) 1.50 (0.94) 1.25 (0.96) 1.69 (0.95)
1.42 (0.91) 1.42 (0.93) 1.22 (0.97) 1.59 (0.92)
1.85 (0.88) 1.89 (0.94) 1.44 (0.96) 2.19 (0.98)
1.18 (0.89) 1.32 (0.86) 0.86 (0.89) 1.35 (0.99)
Values given as ⫾ (SD) (n ⫽ 44).
in 4 parts with a total score and functional, emotional, and physical subscores. Two additional questions were included in the RDI to determine whether patients completed the entire course of prescribed medication and whether they thought that the medicine made them feel better. All except 3 of the 44 patients who responded completed the medication as prescribed. Seven of the 44 patients thought that they did not get better. Only 1 of the 7 who indicated no improvement did not complete the full course of medication. Results of the RDI are listed in Table 6; they are broken down into the results of all patients compared with historical controls and the results of those who stated they did improve compared with those who stated they did not. There was no statistical significance between any of the comparison groups (all surveyed vs historical controls, those who felt better vs those who did not feel better, and those who felt better vs historical controls). DISCUSSION Although medicine has evolved into a detailed science, both the practice of medicine and the application of medical principles remains an art. Evaluation and treatment center on the traditional physician-patient relationship with an exchange of information and knowledge between the caregiver and the patient. Rapid advancement on the science side of medicine has resulted in simple, modern-day treatments for problems that were once uniformly fatal. Rapid advancement has also created new possibilities for treatment that are based on sound principles at the individual level but that are lacking evidence-based proof of overall effectiveness. In the diagnosis and treatment of ABRS, a number of diagnostic tools (nasal endoscopy, paranasal sinus computed tomography) and a number of treatment
tools (antibiotics) are available. Each tool has been successful in individual circumstances, but its overall value across groups in achieving an effective and efficient outcome has not been proved. Rapidly increasing health care costs have been attributed to inefficiencies in the way health care is provided. Managed care has evolved as a way to regain control over these increasing costs. As a result, MCOs are beginning to direct the way health care is provided at the individual practitioner level. Clinical protocols are now recognized as a tool for MCOs to direct care cost effectively and efficiently. They are most usefully applied to conditions with high prevalence and high dollar costs. Because of the inefficiencies surrounding both the diagnosis and the treatment of ABRS, it is an ideal condition for clinical protocol use. From a business standpoint, the concept of clinical protocol utilization in modern health care makes sense and should probably be expanded. From a health care provider standpoint, clinical protocols can represent a threat to individual autonomy. This perceived threat has resulted in underuse by health care providers. Unfortunately, health care costs are continuing to rise and MCOs are faced with the burden of curtailing costs yet providing quality care. The clinical protocol outlined for the treatment of ABRS has been designed to achieve the desired results while allowing for some autonomy by the care provider. The main purpose of the protocol is to educate the care provider in how to recognize and treat ABRS in a cost-effective manner. The protocol succeeded in ensuring that all symptoms related to sinonasal disease were evaluated in each patient. In contrast, the chart review and provider survey showed a poor understanding of the importance of certain
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symptoms and a general lack of inquiry into the different symptoms. The results also show that providers’ prescribing habits can be directed through the use of a protocol. Despite a number of published reports suggesting that amoxicillin and SMZ/TMP are adequate for the treatment of uncomplicated rhinosinusitis, the chart review identified that only 49.4% of patients were treated with either of these 2 antibiotics. After implementation of the protocol, the number of patients treated with either of these 2 first-line therapies jumped to 68.5%. The protocol also successfully eliminated the use of inappropriate antibiotics such as cephalexin that do not cover the 3 common bacteria associated with ABRS. The RDI results did not provide any statistical significance in terms of measuring symptom improvement. In fact, the raw scores for all patients asked to fill out the survey after completion of treatment were actually worse than historical controls of patients with known sinonasal disease. These results suggest that use of the RDI as a static measure of patient symptoms is inappropriate and serial measurements are probably needed to measure differences. In this particular case, it is likely that asking individuals to try to distinguish current symptoms from previous symptoms introduces significant recall bias. Despite the inability to measure improvement with the RDI, this project found that 84.1% of the individuals who responded to the survey thought that they were better after completing the antibiotic course. These results suggest a number of possibilities, including that a majority of patients did improve but the RDI could not measure improvement or that, regardless of treatment, ABRS is a self-limited disease and pharmaceutical treatment offers only placebo effect. The subjective improvement reported by the patients also suggests that amoxicillin and SMZ/ TMP may be just as good as the more expensive antibiotics, a concept suggested by an number of recognized authorities, including the Agency for Healthcare Research and Quality.3 Any clinical protocol must undergo testing before it can be considered a standard of care. Because health care is not a static science, clinical protocols must also be continually reviewed and updated to remain effective. This work is meant to outline a clinical protocol for the diagnosis and
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treatment of ABRS using evidence-based data generated from the literature. Before full implementation, the protocol must be tested to show whether it can accomplish the goal of achieving a quality result while remaining cost-effective. No significant conclusion can be made at this point in the evaluation process. CONCLUSION Rhinosinusitis represents a significant medical problem worldwide and consumes a large portion of health care dollars. Many forms of evaluation and management of adult ABRS exist, and the approach to treatment can vary among clinicians. The value of clinical protocol utilization to direct treatment in a cost-effective manner using evidence-based scientific literature has been shown. Clinical protocols for the diagnosis and treatment of ABRS may focus care to achieve a quality result in a cost-effective manner. Before implementation, the validity of the clinical protocol must be assessed in a prospective study. The author acknowledges the assistance of Richard Burns, MD, Clinic Director of the Fairview Internal Medicine Clinic, for his assistance in evaluation of the protocol and Pam Fuller for her assistance in collecting the history information. In addition, the following Fairview Internal Medicine Clinic physicians are recognized for their willingness to use the protocol to treat their patients: Richard Burns, Sharon Carmignani, Thomas Cheek, James Koller, and Kristen HahnCover. The author is also grateful to Martha Bowes for manuscript preparation. REFERENCES
1. Gwaltney JM. Acute community-acquired sinusitis. Clin Infect Dis 1996;23:1209-25. 2. Am Acad Otolaryngol Head Neck Surg Bull 1999;18:910. 3. Agency for Health Care Policy and Research. Diagnosis and treatment of acute bacterial rhinosinusitis: summary, evidence report/technology assessment, No. 9, March 1999. Rockville, MD: Agency for Health Care Policy and Research. http://www.ahrq.gov/clinic/sinussum.htm. 4. Lanza DC, Kennedy DW. Adult rhinosinusitis defined. Otolaryngol Head Neck Surg 1997;117:S1-7. 5. Fox PD. An overview of managed care. In: Kongstvedt PR, ed. The managed health care handbook. 3rd ed. Gaithersburg, MD: Aspen Publishers; 1996. p. 3-15. 6. Poole MD. Antimicrobial therapy for sinusitis. Otolaryngol Clin North Am 1997;30:331-9. 7. Dolhman AW. Role of antibiotic and non-antibiotic therapy in the treatment of sinusitis with an allergic basis. Clin Exp Allergy 1994;24:1094-7.
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8. Anon JB. Report of the Rhinosinusitis Task Force Committee Meeting. Otolaryngol Head Neck Surg 1997;117: S1-S68. 9. Sinus and Allergy Health Partnership. Antimicrobial treatment guidelines for acute bacterial rhinosinusitis. Otolaryngol Head Neck Surg 2000;123(suppl 2):S1-S32. 10. Benninger MS, Senior BA. The development of the Rhinosinusitis Disability Index. Arch Otolaryngol Head Neck Surg 1997;123:1175-9. 11. Senior SA, Glaze C, Benninger MS. Use of the Rhinosinusitis Disability Index (RDI) in rhinologic disease. Am J Rhinol 2001;15:15-20.
12. de Farranti SD, Ioannidis JPA, Lau J, et al. Are amoxicillin and folate inhibitors as effective as other antibiotics for acute sinusitis? a meta-analysis. Br Med J 1998;317: 632-63. 13. de Bock GH, Dekker FW, Stolk J, et al. Antimicrobial treatment in acute maxillary sinusitis: a meta-analysis. J Clin Epidemiol 1997;50:881-90. 14. Benninger MS, Sedory-Holzer SE, Lau J. Diagnosis and treatment of uncomplicated acute bacterial rhinosinusitis: summary of the Agency for Health Care Policy and Research evidence-based report. Otolaryngol Head Neck Surg 2000;122:1-7.
American Academy of Otolaryngic Allergy Course and Meeting Schedule for 2002 Basic Course in Otolaryngic Allergy, Summer 2002, exact dates and location to be announced. Annual Meeting, Sept 19-21, 2002, in San Diego, CA. Advanced Course in Otolaryngic Allergy and Immunology, Dec 5-8, 2002, at the Resort at Squaw Creek in Lake Tahoe, CA. For additional information, contact Laura Chaplin, Meetings and Membership Coordinator, American Academy of Otolaryngic Allergy (AAOA), 1990 M Street, NW, Suite 680, Washington, DC 20036; tel, 202-955-5010 ext 106; fax, 202-955-5016; www.aaoaf.org.