Five New Clinical Guidelines in Primary Care: What we all need to know. Learning Objectives. Clinical Practice Guidelines

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1 Five New Clinical Guidelines in Primary Care: What we all need to know Annie Abraham, MSN, RN, FNP-BC Assistant Clinical Professor Texas Woman s University Dallas, TX Learning Objectives Discuss up-to-date guidelines on treatment of Acute Otitis Media and Sinusitis in children Discuss recent guidelines for diagnosis and management of Hypertension Explain current trends in Obstructive Sleep Apnea (OSA) and Prostate Cancer screening Clinical Practice Guidelines CPGS are statements that include recommendations intended to optimize patient care (IOM, 2011) Based on a systematic review of evidence and an assessment of the benefits and harms of alternative care options. Reduce unnecessary variations in clinical practice Designed with flexibility for individual patients who fall outside the scope of the guideline. Outcomes meaningful to patients Time sensitive Rating scheme Quality and strength of studies Level of evidence Class or grade of recommendations 1

2 Clinical Guidelines Updates Pediatric Acute Otitis Media Management Pediatric Sinusitis Management Prostate Cancer Screening Obstructive Sleep Apnea (OSA) Hypertension Management DIAGNOSIS AND MANAGEMENT OF ACUTE OTITIS MEDIA IN PEDIATRICS: AAP 2013 GUIDELINES AOM Case Study 1 You are seeing a previously healthy 20-monthold boy with a 2-day history of pulling at his left ear. He recently had a cold and is improving. He is afebrile on exam. 2

3 According to the 2013 AAP guidelines for Acute Otitis Media (AOM), which of the following findings is most important in diagnosing AOM among children? Bulging TM Degree of erythema of the TM Fever Ear pain Guideline changes 2004 guidelines (2mos-12y): Acute onset of symptoms, acute middle ear inflammation, and middle ear effusion. With the 2013 update (6mos-12y): AOM diagnosis is now based on bulging of the TM Wait-and-see approach" has been extended to certain children younger than 2 years AOM Updates Requires middle ear effusion for diagnosis, but has to be based on tympanometry or pneumatic otoscopy. Additional diagnostic criteria include: moderate to severe bulging of the tympanic membrane OR mild bulging of the ear drum and onset of ear pain within 48 hours, which could be indicated by holding, tugging, rubbing of the ear for nonverbal children, or intense redness of the tympanic membrane. 3

4 AOM Case Study 2 The child described in the first question is diagnosed with left AOM. According to the current guidelines, which of the following is the most reasonable course of treatment of this patient? Immediate treatment with amoxicillinclavulanate Immediate treatment with azithromycin Symptomatic treatment only with a prescription for amoxicillin if his condition fails to improve Symptomatic treatment and no antibiotic prescription for at least 7 days 2013 AOM Treatment Updates Antibiotics should be given for severe cases of bilateral or unilateral acute otitis media for children >6 months based on ear pain that is moderate or severe, lasts for at least 48 hours, or is accompanied by a temperature of >102.2 F. In less severe cases, watchful waiting could be offered instead of antibiotics unless both ears are affected in kids aged 6 23 months. 4

5 2013 AOM Treatment Updates Emphasizes assessment and treatment of pain. No specific recommendation Consider risk/benefits and patient/parent preference Acetaminophen/Ibuprofen mainstay for mildmoderate pain Topical agents, home remedies, homeopathic agents, narcotic analgesics 2013 AOM Treatment Updates Prophylactic antibiotics should not be prescribed to reduce recurrences. Offer the option of tympanostomy tubes Amoxicillin (80 90 mg/kg/day)remains the first-line agent Amoxicillin clavulanate (90 mg/kg/day): B- lactamase coverage needed, had amoxicillin in the prior month, or with concurrent conjunctivitis Alternative Treatment Cefdinir (14 mg/kg/day in 1 or 2 doses) Cefuroxime (30 mg/kg/day in 2 divided doses) Cefpodoxime (10 mg/kg/day in 2 divided doses) Ceftriaxone (50 mg/kg/day IM or IV for 1 to 3 d) Clindamycin (30 40 mg/kg/day in 3 divided doses), with or without second- or thirdgeneration cephalosporin for initial antibiotic failure 5

6 Prevention Pneumococcal conjugate vaccine and annual flu shots are recommended for all children Encourage exclusive breastfeeding for at least 6 months Avoidance of tobacco smoke exposure DIAGNOSIS AND MANAGEMENT OF ACUTE BACTERIAL SINUSITIS IN CHILDREN AGED 1 TO 18 YEARS: 2013 AAP GUIDELINE ( Guideline Focus Update of 2001 guideline Focuses on ages 1 18 years Does not consider subacute or chronic sinusitis or children <1 year, with anatomic abnormalities, immunodeficiencies, cystic fibrosis, ciliary dyskinesia 6

7 2013 Areas of change: 1. Addition of worsening course 2. New data on effectiveness of antibiotics 3. Option to observe for 3 days in persistent infection 4. Imaging is not necessary to identify or confirm a diagnosis of acute sinusitis Diagnosing ABS in children Child with an URI presents with: Persistent illness (nasal discharge or daytime cough or both for 10 days without improvement) Worsening course (worsening or new onset of nasal discharge, daytime cough or fever after initial improvement) Severe onset (concurrent fever and purulent nasal discharge for 3 days) 7

8 Imaging recommendations DO NOT obtain imaging studies (plain x-rays, CT, MRI, or ultrasound) to distinguish ABS from viral URI DO obtain CT scan with contrast of the paranasal sinuses and/or an MRI with contrast whenever a child is suspected of having orbital or CNS complications of ABS Imaging In children with uncomplicated URI, majority will be significantly abnormal Normal images = No sinusitis Abnormal images cannot confirm diagnosis and are not necessary in children with uncomplicated clinical sinusitis Antibiotic therapy Prescribe antibiotic therapy for ABS in children with severe onset or worsening course Either prescribe antibiotic therapy OR offer additional outpatient observation for 3 days to children with persistent illness 8

9 Recommendations for Initial Use of Antibiotics for ABS Clinical Presentation Uncomplicated ABS without coexisting illness ABS with orbital or CNS complication ABS with other bacterial infection Severe ABS Antibiotic Worsening ABS Antibiotic Persistent ABS Antibiotic OR Additional observation Antibiotic Antibiotic Antibiotic Antibiotic Antibiotic Antibiotic Suspected Microbiology of ABS, 2013 Streptococcus pneumoniae 15 20% Haemophilus influenzae 45 50% Moraxella catarrhalis 10 15% Streptococcus pyogenes 5% Sterile 25% Antibiotic Resistance S pneumoniae: 10 15%; can increase up to 50% H influenzae: 10 68% M catarrhalis: 100% 9

10 1 st Line Treatment for ABS in children Amoxicillin at 45 mg/kg/day in 2 doses If high prevalence of penicillin-resistant S pneumoniae Amoxicillin at 90 mg/kg/day in 2 doses Treatment Patients with moderate to severe illness, <2 years, attending child care, or have recently been treated with an antibiotic: High dose Amoxicillin-clavulanate mg/kg/day Vomiting, unable to tolerate PO mediation, or adherence concern: Ceftriaxone 50mg/kg IV/IM x 1 Follow up Reassess initial management if there is caregiver report of worsening OR failure to improve within 72 hours If worsening symptoms or failure to improve: change antibiotics or initiate antibiotics in child managed with observation 10

11 Adjuvant Therapies No Recommendation Antihistamines Intranasal steroids Intranasal saline Decongestants EARLY DETECTION OF PROSTATE CANCER: 2013 AMERICAN UROLOGICAL ASSOCIATION (AUA) GUIDELINE Screening in men under 54 years No PSA screening in men under age 40 years. (Recommendation; Evidence Strength Grade C) No routine screening in men between ages 40 to 54 years at average risk. (Recommendation; Evidence Strength Grade C) 11

12 Screening in men 55 to 69 years Shared decision-making for men age 55 to 69 years that are considering PSA screening, and proceeding based on a man's values and preferences. (Standard; Evidence Strength Grade B) The greatest benefit of screening appears to be in men ages 55 to 69 years. Screening in men over 70 years No routine PSA screening in men age 70+ years or any man with less than a 10 to 15 year life expectancy. (Recommendation; Evidence Strength Grade C) Some men age 70+ years who are in excellent health may benefit from prostate cancer screening. Screening interval Screening intervals of two years: most benefit and reduces overdiagnosis and false positives. (Option; Evidence Strength Grade C) 12

13 AAFP/USPSTF 2012 Recommendation The AFFP, in conjunction with the U.S. Preventive Services Task Force (USPSTF) issued a final recommendation against prostatespecific antigen (PSA)-based screening for prostate cancer in asymptomatic men because evidence indicates that the harms of the test outweigh its benefits. Concern The PSA test often produces false-positive results, which are associated with negative psychological effects and other adverse events. Difference in recommendations USPSTF and AAFP: Do not use the PSA test. AUA: Encourages discussion with patients. 13

14 MANAGEMENT OF OBSTRUCTIVE SLEEP APNEA (OSA) IN ADULTS: THE 2013 AMERICAN COLLEGE OF PHYSICIANS (ACP) CLINICAL PRACTICE GUIDELINE OSA Facts 18 million US adults have sleep apnea Hypertension is the most common codiagnosis. OSA is the most common type of sleep apnea, in which the airway collapses or becomes blocked during sleep OSA Case Study You see a 49 year old male patient with a body mass index of 34 kg/m 2 with OSA. According to the current guidelines by the ACP, what should you recommend as the initial treatment of OSA? 14

15 ACP OSA Recommendations Lose weight if overweight or obese Continuous positive airway pressure (CPAP) can be used as initial therapy Mandibular advancement devices (MAD) can be used as an alternative therapy to CPAP Pharmacotherapy Inadequate evidence to support use of agents such as mirtazapine, xylometazoline, fluticasone, paroxetine, pantoprazole, steroid plus CPAP, acetazolamide, and protryptyline in OSA Surgery Risk vs benefit Serious adverse effects Insufficient evidence Not used as initial treatment 15

16 HYPERTENSIONS TREATMENT: A REVIEW OF THE LATEST GUIDELINES HTN Case Study LN, a 38 y/o African American female with stage III chronic kidney disease, presents to her family nurse practioner with persistently elevated blood pressure despite initiating life style changes about 3 months ago. Her blood pressure during today s visit was 152/94. Which antihypertensive agent do you recommend for DB? Hypertension Facts Hypertension is a leading risk factor for cardiovascular disease The overall prevalence of hypertension among U.S. adults aged 18 years in was 30.4% or an estimated 66.9 million ( 16

17 JNC 7 Classification of Blood Pressure Normal: <120 and <80 Pre-hypertension: or Hypertension Stage 1: or Stage 2: 160 or 100 Questions Guiding JNC 8 In adults with hypertension, does initiating antihypertensive pharmacologic therapy at specific BP thresholds improve health outcomes? In adults with hypertension, does treatment with antihypertensive pharmacologic therapy to a specified BP goal lead to improvements in health outcomes? In adults with hypertension, do various antihypertensive drugs or drug classes differ in comparative benefits and harms on specific health outcomes? New HTN treatment guidelines 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report from the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) American Society of Hypertension and the International Society of Hypertension Clinical Practice Guidelines for the Management of Hypertension in the Community 2013 European Society of Hypertension/European Society of Cardiology Guidelines 17

18 Areas of agreement 140/90 for both goal and threshold Individuals younger than 60 Individuals with diabetes Individuals with chronic kidney disease (CKD) without significant proteinuria JNC Recommendations Guideline Goal BP and Initial Drug Therapy for Adults With Hypertension JAMA. 2014;311(5): doi: /jama General population aged 60 years Initiate treatment: SBP > 150 OR DBP > 90 Treatment goal: SBP < 150 OR DBP < 90 * No need for adjustments if SBP<140 and treatment well tolerated and without adverse effects. 18

19 General population aged < 60 years Initiate treatment: DBP > 90 & SBP > 140 Treatment goal: DBP < 90 and SBP < years or older with CKD and HTN Initiate treatment: SBP > 140 OR DBP > 90 Treatment goal: SBP < 140 OR DBP < years or older with diabetes Initiate treatment: SBP > 140 OR DBP > 90 Treatment goal: SBP < 140 OR DBP < 90 19

20 General nonblack population (including those with diabetes) Initial antihypertensive treatment should include any of the following: A thiazide-type diuretic Calcium channel blocker (CCB) Angiotensin-converting enzyme inhibitor (ACEI) Angiotensin receptor blocker (ARB). General black population (including those with diabetes) Initial antihypertensive treatment should include: Thiazide-type diuretic or CCB 18 years or older with CKD and HTN Initial (or add-on) antihypertensive treatment should include an ACEI or ARB to improve kidney outcomes. This applies to all CKD patients with hypertension regardless of race or diabetes status. 20

21 HTN Case Study LN, a 38 y/o African American female with stage III chronic kidney disease, presents to her Family Nurse Practitioner with persistently elevated blood pressure despite initiating life style changes about 3 months ago. Her blood pressure during today s visit was 152/94. Which antihypertensive agent do you recommend for DB? HTN treatment objective The main objective of hypertension treatment is to attain and maintain goal BP. If goal BP is not reached within a month of treatment: Increase the dose of the initial drug OR Add a second drug from one of the classes in recommendation 6 (thiazide-type diuretic, CCB, ACEI, or ARB). The clinician should continue to assess BP and adjust the treatment regimen until goal BP is reached. Reaching BP goal If goal BP cannot be reached with 2 drugs: Add and titrate a third drug from the list provided. Do not use an ACEI and an ARB together in the same patient. If goal BP cannot be reached using the drugs in recommendation 6 because of a contraindication or the need to use more than 3 drugs to reach goal BP: antihypertensive drugs from other classes can be used. 21

22 Reaching BP goal For patients in whom goal BP cannot be attained using the above strategy OR The management of complicated patients for whom additional clinical consultation is needed. Referral to a hypertension specialist may be indicated JNC Management Guideline Algorithm Adult aged 18 years and older who have hypertension Implement lifestyle interventions (continue throughout management) Set BP goal and initiate BP-lowering medication on the basis of age, diabetes status, and CKD Select a drug treatment titration strategy A. Maximize first medication before adding second or B. Add second medication before reaching maximum dose of first medication or C. Start with 2 medication classes separately or as fixed-done combination No At goal BP? Reinforce medication and lifestyle adherence For strategies A and B, add and titrate thiazide-type diuretic or ACEI or ARB or CCB (use medication class not previously selected and avoid combined use of ACEI and ARB). For strategy C, titrate doses of initial medications to maximum. No At goal BP? Reinforce medication and lifestyle adherence Add and titrate thiazide-type diuretic or ACEI or ARB or CCB (use medication class not previously selected and avoid combined use of ACEI and ARB). No At goal BP? Yes Reinforce medication and lifestyle adherence Add additional medication class (eg, beta-blocker, aldosterone antagonist, or others) and/or refer to physician with expertise in hypertension management. At goal BP? James PA, et al. JAMA. 2014;311: [1] Continue current treatment and monitoring Initial Drug Choices JNC 8 ASH Nonblack: Thiazide-type diuretic, ACEI, ARB, or CCB Nonblack and > 60: Thiazide diuretic or CCB (ACEI or ARB) NonBlack and < 60: ACEI or ARB Black Patients: Thiazide-type diuretic, or CCB Patients with Diabetes: Thiazide-type diuretic, ACEI, ARB, or CCB CKD: ACEI and ARB Black Patients: Thiazide-type diuretic, or CCB Patients with Diabetes: ACEI or ARB (Blacks: May also consider Thiazide-type diuretic or CCB) CKD: ACEI and ARB 22

23 BP measurement Use right size arm cuff. BP should be taken after patients have emptied their bladders and seated with their backs supported and legs resting on the ground (uncrossed) for 5 minutes. Take 2 readings, 1 to 2 minutes apart, and average them. The patient s arm being used for the measurement should be at the same level as the heart, with the arm resting comfortably on a table. Measure BP in both arms at initial evaluation. Confirm diagnosis at an additional patient visit. Weber et al, The Journal of Clinical Hypertension, 2014, 16: Lifestyle Modifications for Hypertension Control Weight loss if overweight: 5-20 mmhg/10-kg weight loss Limit alcohol to 1 oz/day: 2-4 mm Hg Reduce sodium intake to 100 meq/d (2.4 g Na): 2-8 mm Hg in SBP DASH Diet: 6 mm alone; 14 mm plus Na Physical activity 30 min/day: 4-9 mm Hg THANK YOU!! QUESTIONS? 23