Member Groups Requesting Changes: Lakeview Clinic Marshfield Clinic Mayo Clinic South Lake Pediatrics Response Report for Review and Comment January 2013 Diagnosis and Treatment of Respiratory Illness in Children and Adults Guideline Member Groups that Reviewed the Guideline, No Changes Requested: CentraCare Member Groups that Responded but the Guideline Does Not Pertain to Practice: None Sponsoring Health Plans Requesting Changes: HealthPartners Health Plan Sponsoring Health Plans that Reviewed the Guideline, No Changes Requested: Medica GENERAL COMMENTS: 1) Used as a resource. Thank you for your comment. We are pleased that our members find our guidelines useful. 2) It is a great guideline with lots of useful information. (Mayo Clinic) o (Pg 15)- Under "Are complicating factors present?" - Consider adding "children with chronic problems (g-tubes, seizures, chronic respiratory problems) and syndromes (Down's, Rett's, etc)" to the list of exceptions to the guideline. These children should probably be offered an appointment, as they tend to get sicker faster than healthy children. - 1 -
Thank you for your comment. The list was not meant to be limiting in conditions listed. The 1 st bullet has been changed to reflect adults and children with chronic illness/disease/conditions. o (Pg. 22) Change "Acetaminophen should be suggested "to "Acetaminophen or ibuprofen should be suggested " Ibuprofen rarely causes stomach upset in children and most families prefer it to acetaminophen. Thank you for your comment. Annotation #12, under the Children s section has been revised to Acetaminophen or ibuprofen may be suggested. o (Pg. 23) under "Call back if " Would add "ear pain" and "worsening cough" to the second bullet point. Otitis media and pneumonia are the most common secondary infections in children. Thank you for your comment. These symptoms would be considered new and would be included under bullet point two, or if new symptoms appear. In addition, the list for new symptoms was not meant to be all-inclusive. o (Pg. 39) in Table 1, under Comments for the 2nd generation antihistamines: Fexofenadine and cetirizine are now also over the counter - they should be added to loratidine. Thank you for your comment. We have updated fexofenadine and cetirizine in the comments section to the list of over-the-counter medications available and will now be viewed as Cetirizine, Fexofenadine and Loratadine are available as over the counter options. o ( Pg. 39) Again in Table 1: There is a typo in the Comments box for Montelukast - take out the word "loratidine". Thank you for your comment. We have removed antihistamines, and the statement will now read, May be as effective as loratadine but less effective than other antihistamines and nasal steroids. o Sulphamethoxazole is spelled incorrectly throughout - it should be "Sulfamethoxazole with an "f", not a "ph". Thank you for your comment. We have updated the guideline to reflect the correct spelling of sulfamethoxazole throughout. 3) This guideline is used in the following way in our organization: Partial implementation. The following sections of the guideline or issues present barriers in implementation: A few questions they suggest a patient might have sinusitis, rather than a common cold, if symptoms are not improving by 7-10 days. We have been using the longer time frame of 10-14 days. Also, it might be sinusitis if symptoms are getting worse at 3-5 days. We often have been using a longer time frame, 7 days. (South Lake Pediatrics) Thank you for your comment. We have reviewed the literature and agree with your recommendation to change the time frame for the clinical diagnosis of acute bacterial - 2 -
sinusitis. In the past, there has been a difference in the literature in recommendations for duration of illness before making a clinical sinusitis diagnosis. In general, in pediatric patients, the recommendation was for a longer time frame than adults. However, earlier this year, the Infectious Diseases Society of America (IDSA) released the IDSA Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults that uses the same criteria for both children and adults. As a result, we will be changing the Annotation on Patient has Symptoms Suggestive of Bacterial Sinusitis in the ICSI guideline. MEDICAL CONTENT: 4) Strep Pharyngitis Algorithm (Antibiotics to avoid side box): Consider adding a notation regarding to potential for local resistance to macrolides.. Thank you for your comment, the following statement about the potential for local resistance to macrolides was added; Although Macrolides may be an acceptable alternative, providers should check their local resistance patterns. 5) Algorithm #11 (side box): Last dot point should say infection of conjunctiva. Thank you for your comment, however, the algorithm was intended to read injection of conjunctiva (red eyes). 6) Annotation #4: Second to the last dot point under complicating factors; Sore throat for more than 5 days. We use 3 days for sore throat alone and 5 days for sore throat accompanied with cold symptoms for referral. Thank you for your comment. The work group felt that patients with less than five days of sore throat and no other symptoms would be safely managed going through the pharyngitis algorithm, which may, or may not include a clinician appointment depending upon complicating factors. 7) Annotation #11: Please correct the title should read infection not injection. Consider adding information about influenza: Seasonal influenza can start as early as October and last until May. Approximately 5-20% of Americans have the flu during each flu season. Early presentations of influenza can include symptoms of viral upper respiratory infection (VURI). Centers for Disease Control (Jan. 6, 2011). Seasonal flu: The flu season. Retrieved from: http://www.cdc.gov/flu/about/season/flu-season.htm Thank you for your comment. Annotation #11, paragraph two, has been updated to reflect the following addition, Influenza is a viral upper-respiratory infection and has the potential to be more serious and differentiated by degree of illness, season, impressive myalgia and epidemiology. Please see http://www.cdc.gov/flu/about/season/flu-season.htm for more information. - 3 -
8) Annotation #11 Table 2 Otitis Media Symptoms: Consider removing ear popping and fullness and replace with pain that interferes with normal activity and sleep. Thank you for your comment. We have removed ear popping and fullness from the table. The work group, however, did not feel the need to further classify otalgia with activity or sleep interference. 9) Annotation #12, Consider adding honey to home care advice: Honey thins the mucous in the back of the throat and loosens a cough. White corn syrup can be used if honey is not available. Children Age 1 year or older: Give ½ to 1 teaspoon (2-5 ml) of honey as needed. May be repeated every 2-4 hrs while awake as needed. Adults: Take 2 teaspoons of honey at bedtime to help decrease cough at night. Thank you for your comment. Honey has been added to the comfort measures section, however, dosage information was not included as we have not found evidence that supports specific dosing. 10) Annotation #12: Children up to age 18 months who have not received immunizations should be thoroughly evaluated. Thank you for your comment. The work group agrees with your comment and has reflected this in Annotation #4, to reflect the above-mentioned change this guideline should be applied with caution to pregnant women and under-immunized children. 11) Annotation ## 12: Consider revising information on intranasal zinc. Intranasal zinc gluconate therapy can cause anosmia. The FDA recommends against use of these products and has recommended discontinuing the manufacturing of these products. http://www.fda.gov/downloads/drugs/drugsafety/drugsafety. Thank you for your comment. Although we already include a statement regarding intranasal zinc and anosmia, we have updated the section to further clarify the distinction between intranasal zinc gluconate and oral zinc gluconate. 12) Algorithm #13: My only comment on strep throat symptoms is that I have had several cases where the patient had only a headache or abdominal pain without other symptoms and a possible strep throat exposure at school. (Lakeview Clinic, LTD) Thank you for your comment. The work group feels that based upon current literature, the cases mentioned above would suggest the patients were potentially carriers. 13) Annotation #20: Consider adding information regarding potential local resistance to macrolides. Second dot point under key points; consider replacing erythromycin with another example. Erythromycin has low tolerability and is associated with many drug interactions. Thank you for your comment. Erythromycin has been replaced with macrolides in the second paragraph, Annotation #20. - 4 -
14) Annotation # 23: Consider moving the 2 nd paragraph prior to the paragraph discussing Lemierres syndrome. It seems out of place in the discussion. (Marshfield Clinic) Thank you for your comment. Your suggestion has been incorporated. 15) Annotation # 34: "Leukotriene" is misspelled in the medication therapy box. Suggest completing the table for leukotriene receptor blockers (no rating for sneezing, runny nose, or itching. Thank you for your comment. The spelling of leukotriene has been updated and the table has been completed to indicate slight effect for sneezing, runny nose and itching with leukotriene receptor blocks. 16) Annotation # 34, Corticosteroids: Consider classifying budesonide as once daily vs. twice daily administration; (budesonide (Rhinocort ) as solution is no longer available and was administered twice daily. Budesonide (Rhinocort Aqua ) as suspension is available and is administered once daily. Thank you for your comments, currently ICSI is removing all dosing recommendations due to our revision cycle and the inability for just-in-time changes, all of the dosing recommendations listed above have been removed. 17) Annotation # 34, Antihistamines: Under antihistamines; after second sentence, suggest adding the following: Prophylactic use of oral antihistamines may be initiated a few weeks prior to the expected allergy season." Thank you for your comment. The work group was unable to find any references to support this recommendation therefore this was not included in this revision. 18) Annotation # 34, 3 rd paragraph: Beclomethasone is available, please delete no longer available. Thank you for your comment. This has been corrected. 19) Annotation #34, Decongestants: Are there studies stating that oral decongestants work for allergic rhinitis? We are not aware of any. The use of decongestants is not recommended for children under age 6. Thank you for your comment. The use of decongestants below age six should be used with caution. The annotation has been updated to reflect this. 20) Annotation # 34: Cromolyn is a good alternative for patients who are not candidates for corticosteroids." Is this evidence based? Thank you for your comment. The word good has been removed and the guideline has been updated and reflects the following: Cromolyn is an alternative for patients who are not candidates for corticosteroids. - 5 -
21) Annotation # 34 Leukotriene modifier: The table on p. 33 lists leukotriene receptor blockers, yet there is no discussion following. Although we do not feel this class is optimal therapy for allergic rhinitis, should a brief summary be added to the guideline even if it is to discuss the limitations of the class? Consider the following: Montelukast, a leukotriene modifier, may be considered as a third-line option after failure of a nasal corticosteroid and an oral antihistamine in those 6 years of age. Note: zafirlukast (Accolate ) is not FDA approved for the treatment of allergic rhinitis. Headache is the most commonly reported adverse event. Neuropsychiatric events (e.g., insomnia, agitation, depression, suicidal ideation) are listed as a precaution in package labeling and these events should be monitored in patients. Consider discontinuing leukotriene modifier if patient develops neuropsychiatric symptoms. Allergic rhinitis and its Impact on Asthma (ARIA) 2008, p. 55, 56, 59, 60. Clinical Pharmacology. Thank you for your comment. We have incorporated some information regarding montelukast. 22) Annotation # 34, Cromolyn: The last sentence under cromolyn discussion states that cromolyn is a good alternative. Is this a subjective statement? Thank you for your comment. The word good has been removed and the guideline has been updated to reflect the following: Cromolyn is an alternative for patients who are not candidates for corticosteroids. 23) Annotation # 41, Oral Decongestants: We are not aware of any good studies for the effectiveness of oral decongestants. Also, the APP recommends no decongestants or cough suppressants (DM) for under age 6, and this is not discussing in the guideline. Thank you for your comment. The use of decongestants below age six should be used with caution. The annotation has been updated to reflect this. 24) Annotation # 45, Bacterial Sinusitis: There have been considerable revisions and changes to the recommendations for acute bacterial rhinosinusitis by the IDSA. Consider revising the entire section. Consider using their algorithm and medication tables. Please see attached word document for recommendations and highlights of the update. Thank you for your comments and suggestions. We have reviewed additional information and have updated this annotation. 25) Annotation # 47, Plain Sinus X-rays or other imaging: There is no information regarding other imaging Consider adding information regarding CT scans of the sinuses. Computerized tomography (CT) scan of the sinuses is the best radiologic technique for evaluation of sinusitis. CT scans are recommended for acute sinusitis only if there is a severe infection, complications, or a high risk for complications. CT scans are useful for diagnosing chronic or recurrent acute sinusitis. Sinus X-rays are not as accurate as CT scans or endoscopy in identifying abnormalities in the sinuses. For example, more than one x-ray is needed for diagnosing frontal and sphenoid sinusitis. X-rays do not detect ethmoid sinusitis at all. This area can be the primary site of an infection that has spread to the maxillary or frontal sinuses. - 6 -
Recommendations Regarding Imaging for Acute Sinusitis from the American Academy of Pediatrics Recommendation 2a Imaging studies are not necessary to confirm a diagnosis of clinical sinusitis in children < 6 years of age (strong recommendation based on limited scientific evidence and strong consensus of the panel). Recommendation 2b CT scans of the paranasal sinuses should be reserved for patients in whom surgery is being considered as a management strategy (strong recommendation based on good evidence and strong panel consensus). Reference American Academy of Pediatrics: Subcommittee on Management of Sinusitis and Committee on Quality Improvement. Clinical Practice Guideline: Management of Sinusitis. Pediatrics 108 No. 3 September 2001. Thank you for your comments. We have added information to this annotation regarding other imaging and recommend that imaging is limited and only reserved for special situations. The American College of Radiology Pediatric Sinusitis Guideline has been referred to in the pediatric population. 26) Annotation # 50: regarding bacterial sinusitis in paragraph 2 under Antibiotics it states that 30%-40% of H. influenzae and most M. cattarhalis are resistant to Amoxicillin and that S. Pneumoniae and H. influenzae account for 70% of isolates in adults. Yet in paragraph 4, Amoxicillin is still recommended as the 1 st line drug of choice. Up to date data came out on 5/30/12 and recommends Augmentin as its 1 st line drug due to the large amount of Amoxicillin resistance. Also on acute sinusitis: it states that trimethoprimsulphamethoxazole is not approved by the FDA for the treatment of acute bacterial sinusitis yet in the middle of this page it states, after 10-14 days of failure of first line antibiotic (amoxicillin or trimethoprim-sulphamethoxazole) Should we be recommending trimethoprim-sulphamethoxazole as a 1st line agent if it is no FDA approved? (Lakeview Clinic, LTD) Thank you for your comments. We have updated the guideline to reflect the current recommendations for antibiotics. 27) Annotation # 51: Cefprozil and cefdinir are FDA approved medications for sinusitis. Thank you for your comment. This change has been incorporated PRIORITY AIMS AND SUGGESTED MEASURES: 28) Aims and Measures #2b: Change it to read percentage of patients with a diagnosis of strep pharyngitis. Since the way it reads now it doesn t make sense. (without a RSS of TC you can t accurately diagnose strep). (Lakeview Clinic, LTD) - 7 -
Thank you for your comment. This change has been incorporated. 29) Aims and Measures # All: Please consider including diagnosis and procedure codes in the guideline, which would introduce consistency and insure comparable rates over time and across organizations. (HealthPartners Health Plan) Thank you for your comment. ICSI is no longer including diagnosis and procedure codes in the measurement specifications. 30) Aims and Measures #2b and 3a: Please consider revising the denominator. Because these measures are focused on patients who were treated with antibiotics, it follows that the denominators would be the subset of the population that were prescribed antibiotics, rather than the whole population. Note these should be the same denominators as in measure 4a. Also, consider stating these as inverse rates so that improvement is shown as an increase. (HealthPartners Health Plan) Thank you for your comment. This change has been incorporated. SUPPORT FOR IMPLEMENTATION: None - 8 -