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© 2016 American College of Physicians The information contained herein should never be used as a substitute for clinical judgment. BEYOND THE GUIDELINES: Would you recommend antibiotics for this patient with acute upper respiratory symptoms? Medicine Grand Rounds September 29, 2016 Discussants BIDMC Series Editor Moderator Diane Brockmeyer, MD Howard Libman, MD Deborah Cotton, MD, MPH Howard Gold, MD The Series Editors have no conflicts of interest to disclose. Conflict of Interest Disclosure The speakers have no financial relationships with a commercial entity producing healthcare-related products and/or services. Howard Libman, MD Deborah Cotton, MD, MPH Diane Brockmeyer, MD Howard Gold, MD OUR PATIENT • Mr. X is a 62 y.o. man with a history of recurrent sinusitis • He takes an oral antihistamine and nasal steroids throughout the year for allergies • He presents complaining of a several week history of upper respiratory symptoms • His nasal discharge has become thicker and more purulent over the past week • He also reports a low grade fever and facial pain but no other HEENT symptoms OUR PATIENT • Past Medical History: Environmental allergies, recurrent sinusitis (some episodes of which have been treated with antibiotics), benign prostatic hyperplasia, melanoma (s/p interferon treatment), and basal cell carcinoma • Family Medical History: Noncontributory • Medications: Fexofenadine, fluticasone nasal spray, ASA • Allergies: Ampicillin (rash) • He is married and works as a nurse educator at a local clinic • He drinks alcohol infrequently and does not smoke cigarettes OUR PATIENT • Physical Examination: Noteworthy for T=99.6 deg. F, R > L maxillary sinus tenderness, no discharge from nose, normal TMs, and a mildly erythematous pharynx • The patient requests antibiotics for his persistent sinus symptoms Would you treat Mr. X with antibiotics? Text “Yes” or “No” to 22333 (It is not case sensitive) CONTEXT • Acute upper respiratory tract infections are common in primary care practice • While symptomatic management is indicated in the vast majority of cases, patients often request antibiotic therapy based upon the belief that it will have beneficial effects • Antibiotics are prescribed at more than 100 million adult ambulatory visits each year with 41% of these for respiratory conditions *Shapiro DJ, Hicks LA, Pavia AT, Hersh AL. Antibiotic prescribing for adults in ambulatory care in the USA, 2007- 09. J Antimicrob Chemother. 2014;69:234-240. CONTEXT • Over 4.3 million adults are diagnosed with sinusitis each year, and the majority of visits result in an antibiotic prescription, most commonly a macrolide • Concerns raised about the inappropriate use of antibiotics include unanticipated side effects and toxicities, development of multidrug resistance, and unnecessary cost to the patient and society *Fairlie T, Shapiro DJ, Hersh AL, Hicks LA. National trends in visit rates and antibiotic prescribing for adults with acute sinusitis. Arch Intern Med. 2012;172:1513-1514. CONTEXT • Acute sinusitis presents with nasal congestion, purulent nasal discharge, maxillary touch pain, facial pain or pressure, fever, fatigue, cough, hyposmia or anosmia, ear pressure or fullness, headache, and/or halitosis • Symptom duration ranges from 1-33 days, but most cases resolve within one week • Most episodes are caused by viruses or allergens, and only a small percentage is thought to be related to bacterial infection *Meltzer EO, Schatz M, Nathan R, Garris C, Stanford RH, Kosinski M. Reliability, validity, and responsiveness of the Rhinitis Control Assessment Test in patients with rhinitis. J Allergy Clin Immunol. 2013;131:379-386. CONTEXT • The American College of Physicians and the Centers for Disease Control and Prevention recently published advice for high-value care on the appropriate use of antibiotics for acute respiratory tract infections • They conducted a literature review for evidence of the effectiveness of antibiotic use in this setting • It consisted of recent clinical guidelines from professional societies supplemented by randomized controlled trials, metaanalyses, and systematic reviews *Harris AM, Hicks LA, Qaseem A; High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention. Appropriate Antibiotic Use for Acute Respiratory Tract Infection in Adults: Advice for High-Value Care From the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med. 2016;164:425-434. THE GUIDELINE *Harris AM, Hicks LA, Qaseem A; High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention. Appropriate Antibiotic Use for Acute Respiratory Tract Infection in Adults: Advice for High-Value Care From the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med. 2016;164:425-434. THE GUIDELINE *Harris AM, Hicks LA, Qaseem A; High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention. Appropriate Antibiotic Use for Acute Respiratory Tract Infection in Adults: Advice for High-Value Care From the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med. 2016;164:425-434. OTHER GUIDELINES • AAO-HNS: Condition persists for >10 days without improvement or worsening within 10 days after initial improvement • Canadian: Condition persists for >7 days without improvement, worsening after 5-7 days, or severe symptoms for 3-4 days • European: Condition persists for >10 days, worsening after 5 days, or three or more severe symptoms • IDSA: Condition persists for >10 days without improvement, worsening after 5-6 days after initial improvement, or severe symptoms for 3-4 days at beginning of illness *Rosenfeld RM. Response to "Clinically Significant Rhinosinusitis Can Be Asymptomatic". Otolaryngol Head Neck Surg. 2015;153:1078. *Desrosiers M, Evans GA, Keith PK, Wright ED, Kaplan A, Bouchard J, et al. Canadian clinical practice guidelines for acute and chronic rhinosinusitis. Allergy Asthma Clin Immunol. 2011;7:2. *Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012;50:1-12. *Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, et al. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012;54:e72-e112. QUESTIONS TO DISCUSSANTS To structure a debate between our two discussants, we mutually agreed on the following key questions to consider when applying these guidelines to clinical practice and to Mr. X in particular: 1) What clinical features support the diagnosis of acute sinusitis, and how can a practitioner distinguish between allergy-related symptoms, viral infection, and bacterial infection? 2) What are the risks and benefits of using antibiotic therapy to treat acute sinusitis? 3) What would you recommend for Mr. X and why? OUR MODERATOR & DISCUSSANTS Deborah Cotton, MD, MPH (Moderator) Professor of Medicine, Boston University School of Medicine Deputy Editor, Annals of Internal Medicine Diane Brockmeyer, MD Division of General Medicine and Primary Care, BIDMC Assistant Professor of Medicine, Harvard Medical School Howard Gold, MD Division of Infectious Diseases, BIDMC Assistant Professor of Medicine, Harvard Medical School Dr. Brockmeyer An Argument for Antibiotic Use *Reproduced with permission from Patel ZM, Hwang PH. Uncomplicated acute sinusitis and rhinosinusitis in adults: Treatment. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. (Accessed on September 9, 2016.) Copyright © 2016 UpToDate, Inc. For more information visit www.uptodate.com. What clinical features support the diagnosis of acute sinusitis? How can a primary care practitioner distinguish between allergy-related symptoms, viral infection, and bacterial infection? Allergic Viral Bacterial facial pressure frontal headaches anosmia nasal congestion postnasal drip facial pressure frontal headaches anosmia nasal congestion postnasal drip facial pressure frontal headaches anosmia nasal congestion postnasal drip bilateral rhinorrhea (watery, clear) bilateral mucous clear or purulent typically improving or resolved by day 7-10 sometimes fever unilateral mucous purulent often chronic no fever sneezing itching eye symptoms *Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152(2 Suppl):S1-S39. *Ng ML, Warlow RS, Chrishanthan N, Ellis C, Walls R. Preliminary criteria for the definition of allergic rhinitis: a systematic evaluation of clinical parameters in a disease cohort (I). Clin Exp Allergy. 2000;30:1314-1331. *Gwaltney JM, Hendley JO, Simon G, Jordan WS. Rhinovirus infections in an industrial population. II. Characteristics of illness and antibody response.. JAMA. 1967;202:494-500. often lasts more than 10 days often fever maxillary toothache cacosmia (sense of bad odor in the nose) malaise double worsening unilateral facial tenderness on exam elevated ESR and CRP *Hickner JM, Bartlett JG, Besser RE, Gonzales R, Hoffman JR, Sande MA, et al. Principles of appropriate antibiotic use for acute rhinosinusitis in adults: background. Ann Intern Med. 2001;134:498-505. *Hansen JG, Schmidt H, Rosborg J, Lund E. Predicting acute maxillary sinusitis in a general practice population. BMJ. 1995;311:233-236. Principles of Appropriate Antibiotic Use for Acute Sinusitis in Adults *Hickner JM, Bartlett JG, Besser RE, Gonzales R, Hoffman JR, Sande MA, et al. Principles of appropriate antibiotic use for acute rhinosinusitis in adults: background. Ann Intern Med. 2001;134:498-505. How are these predictors of bacterial sinusitis derived? • Description of one such study: – 174 patients presented to primary care with symptoms consistent with bacterial sinusitis – All underwent CT scanning – 122 (70%) had fluid in maxillary sinuses and underwent sinus aspiration – 92 (53% of total, 75% of those with fluid) had mucopurulent fluid on the aspiration – Cultures were then sent *Hansen JG, Schmidt H, Rosborg J, Lund E. Predicting acute maxillary sinusitis in a general practice population. BMJ. 1995;311:233-236. Predicting acute maxillary sinusitis in a general practice population *Hansen JG, Schmidt H, Rosborg J, Lund E. Predicting acute maxillary sinusitis in a general practice population. BMJ. 1995;311:233-236. Predicting acute maxillary sinusitis in a general practice population *Hansen JG, Schmidt H, Rosborg J, Lund E. Predicting acute maxillary sinusitis in a general practice population. BMJ. 1995;311:233-236. Predicting acute maxillary sinusitis in a general practice population *Hansen JG, Schmidt H, Rosborg J, Lund E. Predicting acute maxillary sinusitis in a general practice population. BMJ. 1995;311:233-236. Features correlated with bacterial sinusitis SINUSITIS NO SINUSITIS OR (95% CI) (n = 92) (n = 82) Unilateral Maxillary Pain 47 (51%) 31 (38%) 1.9 (1.0-3.4) Maxillary toothache 61 (66%) 42 (51%) 1.9 (1.0-3.5) Unilateral Maxillary Tenderness on Exam 45 (49%) 28 (32%) 2.5 (1.2-5.2) • ESR>10 mm/h in men, ESR>20 mm/h in women • CRP>10 mg/l *Reproduced from BMJ, Hansen JG, Schmidt H, Rosborg J, Lund E, Vol. 311, pp233-236, © 1995 with permission from BMJ Publishing Group Ltd. What clinical features support the diagnosis of acute sinusitis? How can a primary care practitioner distinguish between allergy-related symptoms, viral infection, and bacterial infection? Allergic Viral Bacterial facial pressure frontal headaches anosmia nasal congestion postnasal drip facial pressure frontal headaches anosmia nasal congestion postnasal drip facial pressure frontal headaches anosmia nasal congestion postnasal drip bilateral rhinorrhea (watery, clear) bilateral mucous clear or purulent typically improving or resolved by day 7-10 sometimes fever unilateral mucous purulent often chronic no fever sneezing itching eye symptoms *Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152(2 Suppl):S1-S39. *Ng ML, Warlow RS, Chrishanthan N, Ellis C, Walls R. Preliminary criteria for the definition of allergic rhinitis: a systematic evaluation of clinical parameters in a disease cohort (I). Clin Exp Allergy. 2000;30:1314-1331. *Gwaltney JM, Hendley JO, Simon G, Jordan WS. Rhinovirus infections in an industrial population. II. Characteristics of illness and antibody response.. JAMA. 1967;202:494-500. often lasts more than 10 days often fever maxillary toothache cacosmia (sense of bad odor in the nose) malaise double worsening unilateral facial tenderness on exam elevated ESR and CRP *Hickner JM, Bartlett JG, Besser RE, Gonzales R, Hoffman JR, Sande MA, et al. Principles of appropriate antibiotic use for acute rhinosinusitis in adults: background. Ann Intern Med. 2001;134:498-505. *Hansen JG, Schmidt H, Rosborg J, Lund E. Predicting acute maxillary sinusitis in a general practice population. BMJ. 1995;311:233-236. Other diagnoses *Reproduced with permission from Patel ZM, Hwang PH. Uncomplicated acute sinusitis and rhinosinusitis in adults: Treatment. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. (Accessed on September 9, 2016.) Copyright © 2016 UpToDate, Inc. For more information visit www.uptodate.com. What are the risks of using antibiotic therapy to treat acute sinusitis? • Mild patient-specific risks: – Self-limited diarrhea – Other GI side effects – Vaginal or other yeast infection – Cost – Medication interactions – Personal risk for subsequent resistance What are the risks of using antibiotic therapy to treat acute sinusitis? • Moderate patient-specific risks: – Allergic reactions – C. difficile infection – Tendinopathy, neuropathy (fluroquinolones) • Severe patient-specific risks: – Anaphylaxis – Stevens-Johnson Syndrome – Severe C. difficile infection Drug Safety Communication, July 2016 FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together *FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects: US FDA; 2016. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm511530.htm. What are the risks of using antibiotic therapy to treat acute sinusitis? • Community and Societal Risks: – Cost – Increasingly resistant organisms, including multidrug resistance *Rauber JM, Carneiro M, Arnhold GH3, Zanotto MB, Wappler PR, Baggiotto B et al. Multidrug-resistant Staphylococcus spp and its impact on patient outcome. Am J Infect Control. 2016;44:e261-e263. *Wener KM, Schechner V, Gold HS, Wright SB, Carmeli Y, et al. Treatment with fluoroquinolones or with beta-lactam-beta-lactamase inhibitor combinations is a risk factor for isolation of extended-spectrumbeta-lactamase-producing Klebsiella species in hospitalized patients. Antimicrob Agents Chemother. 2010;54:2010-2016. What are the benefits of using antibiotic therapy to treat acute sinusitis? • Postulated benefits of treating bacterial infection (although lack of evidence for many): – Shortened duration of symptoms – Fewer lost work days – Fewer medical visits – Decreased risk of (rare) serious complications, such as orbital cellulitis, meningitis, or abscess – There is some evidence that treatment can be costeffective if diagnostic criteria are carefully applied *Balk EM, Zucker DR, Engels EA, Wong JB, Williams JW Jr, Lau J. Strategies for diagnosing and treating suspected acute bacterial sinusitis: a cost-effectiveness analysis. J Gen Intern Med. 2001;16:701-711. *Anzai Y, Jarvik JG, Sullivan SD, Hollingworth W. The cost-effectiveness of the management of acute sinusitis. Am J Rhinol. 2007;21:444-451. Cochrane Review 2012: Benefit of antibiotics is likely small and should be reserved for selected cases *Lemiengre, van Driel ML, Merenstein D, Young J, De Sutter AI. Antibiotics for clinically diagnosed acute rhinosinusitis in adults. Cochrane Database Syst Rev. 2012;10:CD006089. Cochrane Review 2012: Many patients had simple URIs • “The three most used inclusion criteria were nasal discharge, facial pain, and common cold or upper respiratory tract infection” • “The mean duration of symptoms before inclusion was approximately seven days” *Lemiengre, van Driel ML, Merenstein D, Young J, De Sutter AI. Antibiotics for clinically diagnosed acute rhinosinusitis in adults. Cochrane Database Syst Rev. 2012;10:CD006089. Trial of 5 days moxifloxacin vs. placebo • Cure rates higher in moxifloxicin (78% vs 67%) but not statistically significant (p=0.19) • But…patients chose to leave the study due to lack of benefit at much higher rates in placebo group (8% moxifloxicin, 22% placebo) (p=0.03) *Hadley JA, Mösges R, Desrosiers M, Haverstock D, van Veenhuyzen D, Herman-Gnjidic Z. Moxifloxacin five-day therapy versus placebo in acute bacterial rhinosinusitis. Laryngoscope. 2010;120:1057-1062. Trial of 5 days moxifloxacin vs. placebo • Moxifloxacin had secondary efficacy: – Decreased SNOT-16 score – Improvement in activity impairment scores – Lower requirement for symptomatic measures – Adverse events similar in both groups *Hadley JA, Mösges R, Desrosiers M, Haverstock D, van Veenhuyzen D, Herman-Gnjidic Z. Moxifloxacin five-day therapy versus placebo in acute bacterial rhinosinusitis. Laryngoscope. 2010;120:1057-1062. What would you recommend to Mr. X and why? • Shared decision-making • Doxycycline 100 mg orally twice a day for 7 days • Symptomatic care Is it plausible that this is bacterial sinusitis? Allergic Viral Bacterial facial pressure facial pressure facial pressure frontal headaches frontal headaches frontal headaches anosmia anosmia anosmia nasal congestion nasal congestion nasal congestion postnasal drip postnasal drip postnasal drip bilateral bilateral unilateral rhinorrhea (watery, clear) mucous clear or purulent mucous purulent often chronic typically improves by day 10 often lasts more than 10 days no fever sometimes fever often fever sneezing maxillary toothache itching cacosmia (sense of bad odor in the nose) eye symptoms malaise double worsening unilateral facial tenderness on exam elevated ESR and CRP *Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152(2 Suppl):S1-S39. *Ng ML, Warlow RS, Chrishanthan N, Ellis C, Walls R. Preliminary criteria for the definition of allergic rhinitis: a systematic evaluation of clinical parameters in a disease cohort (I). Clin Exp Allergy. 2000;30:1314-1331. *Gwaltney JM, Hendley JO, Simon G, Jordan WS. Rhinovirus infections in an industrial population. II. Characteristics of illness and antibody response.. JAMA. 1967;202:494-500. *Hickner JM, Bartlett JG, Besser RE, Gonzales R, Hoffman JR, Sande MA, et al. Principles of appropriate antibiotic use for acute rhinosinusitis in adults: background. Ann Intern Med. 2001;134:498-505. *Hansen JG, Schmidt H, Rosborg J, Lund E. Predicting acute maxillary sinusitis in a general practice population. BMJ. 1995;311:233-236. THE GUIDELINE *Harris AM, Hicks LA, Qaseem A; High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention. Appropriate Antibiotic Use for Acute Respiratory Tract Infection in Adults: Advice for High-Value Care From the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med. 2016;164:425-434. Predicting acute maxillary sinusitis in a general practice population *Hansen JG, Schmidt H, Rosborg J, Lund E. Predicting acute maxillary sinusitis in a general practice population. BMJ. 1995;311:233-236. Antibiotic Therapy – For Mr. X, doxycycline 100 mg orally twice a day for 7 days Guideline: First line antibiotic: If Penicillin allergy: ACP Guideline 2016 amoxicilin with clavulanate doxycycline amoxicillin levofloxacin moxifloxacin Otolaryngology 2015 high dose amoxicillin doxycycline amoxicilin with clavulanate levofloxacin moxifloxacin clindamycin plus cefixime or cefpodoxime ISDA Guidelines 2012 amoxicilin with clavulanate doxycycline levofloxacin moxifloxacin FDA Drug Safety Communication, 7/26/2016 *Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, et al. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012;54:e72-e112. Avoid fluroquinolones unless no other treatment options, due to potential for disabling and potentially permanent side effects, including tendonopathy, nerve, and CNS side effects *Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152:S1-S39. Algorithm for the management of acute bacterial rhinosinusitis *Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, et al. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012;54:e72-e112. Benefits of shared decision-making • Improved patient satisfaction • Improved patient medical knowledge • Decreased sense of conflict *Joosten EA, DeFuentes-Merillas L, de Weert GH, Sensky T, van der Staak CP, de Jong CA. Systematic review of the effects of shared decision-making on patient satisfaction, treatment adherence and health status. Psychother Psychosom. 2008;77:219-222. *Altin SV, Stock S. The impact of health literacy, patient-centered communication and shared decisionmaking on patients' satisfaction with care received in German primary care practices. BMC Health Serv Res. 2016;16:450. Symptomatic Management • • • • • Oral analgesics Saline nasal irrigation Decongestants (oral or topical) Intranasal steroids Chicken soup AKA: natural L-carnosine peptide ("bioactivated Jewish penicillin") *Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152:S1-S39. *Saketkhoo K, Januszkiewicz A, Sackner MA. Effects of drinking hot water, cold water, and chicken soup on nasal mucus velocity and nasal airflow resistance. Chest. 1978;74:408-410. *Renard BO, Ertl RF, Gossman GL, Robbins RA, Rennard SI. Chicken soup inhibits neutrophil chemotaxis in vitro. Chest. 2000;118:1150-1157. *Babizhayey MA, Deyev AI, Yegorov YE. Non-hydrolyzed in digestive tract and blood natural L-carnosine peptide ("bioactivated Jewish penicillin") as a panacea of tomorrow for various flu ailments: signaling activity attenuating nitric oxide (NO) production, cytostasis, and NO-dependent inhibition of influenza virus replication in macrophages in the human body infected with the virulent swine influenza A (H1N1) virus. J Basic Clin Physiol Pharmacol. 2013;24:1-26. Dr. Gold An Argument against Antibiotic Use Overview • Most cases of acute sinusitis are caused by viruses or allergens and resolve within one week • <2% of acute viral URI cases are complicated by bacterial infection • Acute sinusitis can generally be managed symptomatically • Meta-analysis of adults with clinically diagnosed acute sinusitis – Number needed to treat with antibiotics was 18 for 1 patient to be cured more rapidly than with placebo – For every 8 patients treated, one will be harmed by adverse effects of antibiotics *Lemiengre, van Driel ML, Merenstein D, Young J, De Sutter AI. Antibiotics for clinically diagnosed acute rhinosinusitis in adults. Cochrane Database Syst Rev. 2012;10:CD006089. THE GUIDELINE *Harris AM, Hicks LA, Qaseem A; High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention. Appropriate Antibiotic Use for Acute Respiratory Tract Infection in Adults: Advice for High-Value Care From the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med. 2016;164:425-434. Symptoms of acute sinusitis • Acute sinusitis presents with – – – – – – nasal congestion maxillary touch pain fever cough ear pressure or fullness halitosis – – – – – purulent nasal discharge facial pain or pressure fatigue hyposmia or anosmia headache • Clinicians should reserve antibiotic treatment for acute sinusitis for patients with persistent symptoms for more than 10 days *Harris AM, Hicks LA, Qaseem A; High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention. Appropriate Antibiotic Use for Acute Respiratory Tract Infection in Adults: Advice for High-Value Care From the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med. 2016;164:425-434. Mr. X appears to meet criteria • Acute sinusitis presents with – – – – – – nasal congestion maxillary touch pain fever cough ear pressure or fullness halitosis – – – – – purulent nasal discharge facial pain or pressure fatigue hyposmia or anosmia headache • Clinicians should reserve antibiotic treatment for acute rhinosinusitis for patients with persistent symptoms for more than 10 days General thoughts about guidelines • Guidelines are not an excuse to turn off your brain • Regard the limitations in the data noted by guideline authors, the caveats, the nuances • Question authority – scratch the surface of a guideline, and you will often find that there is often room for disagreement Psychology matters • Antibiotics are great, but not magic • Association Causation • Antibiotics are terrible, and poor anxiolytics Question 1 What clinical features support the diagnosis of acute sinusitis, and how can a primary care practitioner distinguish between allergy-related symptoms, viral infection, and bacterial infection? Symptoms and signs in culture-proven acute maxillary sinusitis in a general practice population • • • • • ABRS (n = 45) No ABRS (n = 82) OR (95% CI) T > 38°C (100.4°F) 16 (35.5%) 9 (11.0%) 4.6 (1.9-11.2) Maxillary toothache 33 (73.3%) 42 (51.2%) 2.9 (1.3-6.3) Self-reported h/o sinusitis 28 (62.2%) 66 (80.5%) 0.4 (0.2-0.9) CRP 11-49 (mg/L) 17 (37.8%) 10 (12.2%) 8.9 (4-22) CRP >49 (mg/L) 16 (35.6%) 8 (9.8%) 10.5 (4-27) Preceding URTI Cough Nasal congestion Pain bending forward Anosmia • • • Cacosmia • Tenderness on tapping over Purulent nasal discharge maxillary sinus Purulent pharyngeal discharge *Adapted from Symptoms and signs in culture-proven acute maxillary sinusitis in a general practice population, Hansen JG, Højbjerg T, Rosborg J. Copyright © 2009 APMIS. Reproduced with permission of Blackwell Publishing Ltd. Are any clinical findings helpful? No Evidence for Distinguishing Bacterial from Viral Acute Rhinosinusitis Using Symptom Duration and Purulent Rhinorrhea: A Systematic Review of the Evidence Base • “…distinguish…based on purulent rhinorrhea…not supported by evidence” • “after 10 days, antibiotic therapy may seem a reasonable empirical option” No Evidence for Distinguishing Bacterial from Viral Acute Rhinosinusitis Using Fever and Facial/Dental Pain: A Systematic Review of the Evidence Base • “…should not be used …to distinguish between a bacterial and viral source of acute rhinosinusitis” *van den Broek MF, Gudden C, Kluijfhout WP, Stam-Slob MC, Aarts MC, Kaper NM, et al. No evidence for distinguishing bacterial from viral acute rhinosinusitis using symptom duration and purulent rhinorrhea: a systematic review of the evidence base. Otolaryngol Head Neck Surg. 2014;150:533-537. *Hauer AJ, Luiten EL, van Erp NF, Blase PE, Aarts MC, Kaper NM, et al. No evidence for distinguishing bacterial from viral acute rhinosinusitis using fever and facial/dental pain: a systematic review of the evidence base. Otolaryngol Head Neck Surg. 2014;150:28-33. Question 1 Answer • No individual symptom or group of symptoms is highly sensitive or specific for the diagnosis of acute bacterial sinusitis • Radiography (x-ray/CT scan) is not useful in determining the cause of acute sinusitis • Difficult to determine the etiology of acute sinusitis, so the practitioner and the patient have to accept diagnostic uncertainty Question 2 What are the risks and benefits of using antibiotic therapy to treat acute sinusitis? Emergency department visits for antibioticassociated adverse events • Estimated 142,505 visits/yr (95% CI, 116,506–168,504) to US EDs for drug-related adverse events attributable to systemic antibiotics • Antibiotics implicated in 19.3% of ED visits for drugrelated adverse events • Most for allergic reactions (78.7% of visits) • Estimated annual ED visits/10,000 outpatient prescriptions ranged from 5.1 (macrolides) to 13 (penicillins) to >20 (moxifloxacin) *Shehab N, Patel PR, Srinivasan A, Budnitz DS. Emergency department visits for antibiotic-associated adverse events. Clin Infect Dis. 2008;47:735-743. Safety concerns with commonly prescribed antibiotics for URIs - Macrolides • Azithromycin: Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms (3/12/2013) http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343350.htm Safety concerns with commonly prescribed antibiotics for URIs - Fluoroquinolones • FDA Updates Warnings for Fluoroquinolones - Drug Information Update (7/26/2016) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm513183.htm?source=govdelivery&utm_mediu m=email&utm_source=govdelivery Significant decline in erythromycin resistance among group A streptococci with reduced macrolide use *From New England Journal of Medicine, Seppälä H, Klaukka T, VuopioVarkila J, Muotiala A, Helenius H, Lager K, Huovinen P, The effect of changes in the consumption of macrolide antibiotics on erythromycin resistance in group A streptococci in Finland. Finnish Study Group for Antimicrobial Resistance, Vol 337, pp441, Copyright © 1997 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society. Question 2 Answer • Only risks and no benefits of using antibiotic therapy to treat viral sinusitis – Allergies/ADR – Drug resistance – Overgrowth syndromes – Drug-drug interactions • Benefits of antibiotics to treat bacterial sinusitis – Severe disease: benefits > risks – Mild disease: benefits < risks Question 3 What would you recommend for Mr. X and why? Conclusion #3 of ACP and CDC recommendations for appropriate use of antibiotics for acute RTI • Clinicians should reserve antibiotic treatment for acute rhinosinusitis for patients with… • “Antibiotics may be prescribed…” • “Limited benefit” • NNT= 18 > NNH = 8 *Harris AM, Hicks LA, Qaseem A; High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention. Appropriate Antibiotic Use for Acute Respiratory Tract Infection in Adults: Advice for High-Value Care From the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med. 2016;164:425-434. *Lemiengre MB, van Driel ML, Merenstein D, Young J, De Sutter AI. Antibiotics for clinically diagnosed acute rhinosinusitis in adults. Cochrane Database Syst Rev. 2012;10:CD006089. Moxifloxacin five‐day therapy versus placebo in acute bacterial rhinosinusitis • Prospective, multicenter, randomized, double-blind, phase III trial • Enrolled 375 patients with clinical and radiographic evidence of acute sinusitis • 118/374 (31.6%) microbiologically confirmed by sinus puncture • Clinical success rates were not significantly higher for moxifloxacin (78.1%, 57/73) vs. placebo (66.7%, 30/45) (P=0.189) in mITT subjects *Hadley JA, Mösges R, Desrosiers M, Haverstock D, van Veenhuyzen D, Herman-Gnjidic Z. Moxifloxacin five-day therapy versus placebo in acute bacterial rhinosinusitis. Laryngoscope. 2010;120:1057-1062. Safety of reduced antibiotic prescribing for self-limiting respiratory tract infections in primary care: cohort study using electronic health records *Gulliford MC, Moore MV, Little P, Hay AD, Fox R, Prevost AT, et al. Safety of reduced antibiotic prescribing for self limiting respiratory tract infections in primary care: cohort study using electronic health records. BMJ. 2016;354:i3410. Question 3 Answer • I would not recommend antibiotics at this time • I would recommend documentation of fever and maximizing symptomatic treatment • Reassure Mr. X he will probably improve without antibiotics, but would provide them depending on his clinical course • Fever, worsening facial pain or swelling, or lack of improvement with maximal symptomatic treatment reconsider antibiotics • I would not recommend sinus imaging with x-ray or CT scan, otorhinolaryngology referral, or sinus cultures by puncture or endoscopic sampling of the middle meatus Question 3 Answer • Were Mr. X to develop more compelling symptoms or signs of acute bacterial sinusitis, I would recommend treatment: – If he has tolerated other penicillins amoxicillin/clavulanate 875 mg PO twice daily for 5-7 days – If he has not tolerated other penicillins doxycycline 100 mg twice daily for 5-7 days – Generally would not recommend quinolones or macrolides in this setting *Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, et al. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012;54:e72e112. Dr. Brockmeyer & Dr. Gold A Discussion Would you treat Mr. X with antibiotics? Text “Yes” or “No” to 22333 (It is not case sensitive) *If you have not yet joined the voting session, text “BIDMC” to 22333, then follow the directions above. We would like to thank… Our Patient, Mr. X Diane Brockmeyer, MD & Howard Gold, MD Risa Burns, MD, MPH Deborah Cotton, MD, MPH Howard Libman, MD Eileen Reynolds, MD Gerald Smetana, MD Last Minute Productions BIDMC Media Services Kendra McKinnon © 2016 American College of Physicians The information contained herein should never be used as a substitute for clinical judgment.