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Course Materials Professor’s Rounds 2014 Program 8 – PR20148 Approved for 1 contact hour of CRCE ® credit per participant who successfully completes the test. Guidelines-Based COPD Management © 2015 American Association for Respiratory Care

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Page 1: Guidelines-Based COPD Management

Course Materials

Professor’s Rounds 2014 Program 8 – PR20148 Approved for 1 contact hour of CRCE® credit per participant who successfully completes the test.

Guidelines-Based COPD

Management

© 2015 American Association for Respiratory Care

Page 2: Guidelines-Based COPD Management

Page 2

OVERVIEW

Guidelines-Based COPD Management AARC Professor’s Rounds 2014 – Program 8

Description Evidence-based guidelines are growing in prevalence and provide a wealth of information for the clinical management of patients with chronic lung disease. This presentation will explore the most recent guidelines for the management of COPD and discuss the practical integration of guidelines into patient care. Objectives

Learn to identify and discuss: § The impact of COPD in the United States. § The use of spirometry in the diagnosis of COPD. § The appropriate treatment steps for patients based on the seven severity domains of COPD. § Critically evaluate the research and published COPD guidelines.

Presenters

Professor Byron Thomashow, MD Clinical Professor of Medicine, Columbia University Medical Director, Jo-Ann LeBuhn Center for Chest Disease Medical Co-Director, Lung Reduction Program in Emphysema Columbia University Medical Center, New York, NY

Moderator Tom Kallstrom, MBA, RRT, FAARC Executive Director/Chief Executive Officer American Association for Respiratory Care Irving, TX

CRCE® Credit To earn 1 CRCE credit for participating in today’s program: • View entire presentation • Take the 10-question test (available from Proctor/Site Coordinator) • Answer at least 7 questions correctly • Enter your name and AARC member number on the Attendance and CRCE Log (Please do not enter your Social Security Number) • Receive Certificate of Completion from the Proctor/Site Coordinator

Page 3: Guidelines-Based COPD Management

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PROGRAM SLIDES and NOTES

Slide 1

Slide 2

1. Identify the impact of COPD in the United States

2. Discuss the use of spirometry in the diagnosis of COPD

3. Determine appropriate treatment steps for patients based on the seven severity domains of COPD

4. Critically evaluate the research and published COPD guidelines

Objectives

COPD is the nation’s third leading cause of death and second leading cause of disability

In 2012 the CDC published the first ever state by state COPD prevalence rates for COPD based on the Behavioral Risk Factor Surveillance System (BRFSS)

Note: You can access the full MMWR at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6146a2.htm and online database at www.cdc.gov/brfss

The Impact of COPD in the U.S.

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Slide 3

Slide 4

Slide 5

Nationally, an average of 6.3% of adults reported a diagnosis of COPD, equating to over 15 million Americans and roughly 1 in every 15 adults

BUT the NHLBI estimates that an additional 12 million Americans are likely living with COPD without an accurate diagnosis, leading to the possibility that COPD’s impact is even greater than the data reveals

The Impact of COPD in the U.S.

Note: You can access the full MMWR at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6146a2.htm and online database at www.cdc.gov/brfss

COPD in the U.S.

COPD in the U.S.

0.0%

5.0%

10.0%

15.0%

18-44 45-54 55-64 65-74 75+

Prevalence of COPD by Age in the U.S.

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Slide 6

Slide 7

Slide 8

COPD in the U.S.

COPD: Definitions of 21st Century

Preventable and treatable

Airflow limitation that is not fully reversible

Progressive disease Abnormal inflammatory

response of the lungs Subsets of patients

Chronic bronchitis Emphysema

Asthma

COPD

Box = FEV1/FVC < 70% or < LLN

Spirometry is REQUIRED for diagnosis

COPD Challenge Identify more of the 12 million estimated to

have COPD but as yet undiagnosed.

Determine if the diagnosis is correct: • COPD vs asthma, COPD vs CHF • COPD plus asthma, COPD plus CHF

Aim to have those appropriately diagnosed on appropriate therapy

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Slide 9

Slide 10

Slide 11

Spirometry: SG 1 2 3 U

Volu

me,

lite

rs

Time, seconds

5

4

3

2

1

1 2 3 4 5 6

Normal

Obstructive

Restrictive SG Undefined

SG 1-3

Guide to Diagnosis COPD Definition

Defined by post bronchodilator FEV1/FVC ratio<0.7 on spirometry

This helps differentiate from asthma

A significant bronchodilator response (increase in FEV1>12% and >200 cc) can be seen in both COPD and asthma

Asthma vs COPD Asthma

Atopy

Family History

Childhood or young adult onset

Intermittent wheeze/symptoms

Reversible obstruction

Steroid responsive

COPD

Smoking history

Noxious agents

Biomass fuel exposure

Later onset

Progressive symptoms

Partially or non reversible obstruction

+/- Steroid Response

Page 7: Guidelines-Based COPD Management

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Slide 12

Slide 13

Slide 14

Asthma vs COPD Asthma

Atopy

Family History

Childhood or young adult onset

Intermittent wheeze/symptoms

Reversible obstruction

Steroid responsive

COPD

Smoking history

Noxious agents

Biomass fuel exposure

Later onset

Progressive symptoms

Partially or non reversible obstruction

+/- Steroid Response

Asthma vs COPD Therapy Asthma ICS- first line therapy Smoking asthmatics

less responsive Add bronchodilators-

Beta agonists Leukotriene modifiers +/- Theophyllines Smart study concerns

COPD Bronchodilators- first line

therapy Add ICS if recurrent

exacerbations ICS not first line therapy

unless overlap Potentially add roflumilast if

chronic bronchitic with frequent exacerbations

+/- Theophyllines

Asthma vs COPD Therapy Asthma ICS- first line therapy Smoking asthmatics

less responsive Add bronchodilators-

Beta agonists Leukotriene modifiers +/- Theophyllines Smart study concerns

COPD Bronchodilators- first line

therapy Add ICS if recurrent

exacerbations ICS not first line therapy

unless overlap Potentially add roflumilast if

chronic bronchitic with frequent exacerbations

+/- Theophyllines

Page 8: Guidelines-Based COPD Management

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Slide 16

Slide 17

Spirometry Campaigns for PCPs to do office spirometry

have generally been unsuccessful.(2)

Most PCPs do not have a spirometer, those that do rarely use, and more than half of spirometry done by PCPs do not meet ATS quality guidelines. (3)

BRFSS optional module reported spirometry rates ranged from 57% to 81% in various states. (4)

1-Ann Intern Med 2011;155:179-191, 2-Chest…1998;;113(2 Suppl);123S-163S, 3-Lusuardi et al Chest 2006;129(4):844-852, Leuppi et al Respiration. 2010;79(6):469-474, 4- MMWR November 2012

Spirometry ACP Clinical Practice Guidelines 2011: Do

spirometry to diagnose airflow obstruction in patients with respiratory symptoms, NOT in those without respiratory symptoms.(1)

1-Ann Intern Med 2011;155:179-191, 2-Chest…1998;;113(2 Suppl);123S-163S, 3-Lusuardi et al Chest 2006;129(4):844-852, Leuppi et al Respiration. 2010;79(6):469-474, 4- MMWR November 2012

Guide to Diagnosis: SPIROMETRY

Indicated if symptoms present: dyspnea, chronic cough/sputum

Should be considered if: • Risk factors are present- smoking, other exposures,

asthma history, childhood infections, prematurity, family history

• AND if one or more comorbidities present-heart disease, metabolic syndrome, osteoporosis, depression, lung cancer, premature skin wrinkling

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Slide 19

Slide 20

COPD Guidelines Full Document Summary

GOLD 76 pages 19 pages

ATS/ERS Standards

80 pages 15 pages

NICE 673 pages 20 pages

ACP/ACCP/ATS/ERS Consensus Statement

13 pages

Americans with Obstructive Lung Disease Receive 55% of Appropriate Health Care

54% 58%67%

46%48%60%

0%

20%

40%

60%

80%

100%

Asthma COPD

Overall Routine Exacerbation

4058 EPISODES OF CARE Mularski RA et al. Chest 2006; 130(6):1844-1850

Cote & Celli

“COPD HETEROGENEITY”

PT # 1 58 y FEV1: 28%

PT # 2 62 y FEV1: 33%

PT # 3 69 y FEV1: 35%

PT # 4 72 y FEV1: 34%

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Slide 22

Slide 23

Cote & Celli

“COPD HETEROGENEITY”

PT # 1 58 y FEV1: 28% MRC: 2/4 PaO2: 70 mmHg 6MWD: 540 m BMI: 30

PT # 2 62 y FEV1: 33% MRC: 2/4 PaO2: 57 mmHg 6MWD: 400 m BMI: 21

PT # 3 69 y FEV1: 35% MRC: 3/4 PaO2: 66 mmHg 6MWD: 230 m BMI: 34

PT # 4 72 y FEV1: 34% MRC: 4/4 PaO2: 60 mmHg 6MWD: 154 m BMI: 24

Increasing Symptoms

Incr

easi

ng R

isk C D

A B

Incr

easi

ng R

isk

mMRC < 2 CAT < 10

1 2

3

4

GO

LD c

lass

ifica

tion

of

airf

low

lim

itatio

n

0 1

2

or m

ore

Exac

erba

tion

hist

ory

COPD Assessment: A New Model

mMRC > 2 CAT > 10

2 Panel Pocket Consultant

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Mobile App Free in App store: Search COPDFOUNDATION

Other Considerations

Seven Severity Domains 1. Spirometry Grades 2. Regular Symptoms 3. Exacerbations 4. Oxygenation 5. Emphysema 6. Chronic bronchitis 7. Comorbidities

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Slide 29

Severity Domain 1. Spirometry Grades

Spirometry grades

Severity Domain 2. Regular Symptoms •Dyspnea at rest or exertion •Chronic cough/ sputum •Use COPD Assessment Test (CAT) or mMRC Breathless Scale to follow course of disease •Presence of regular symptoms has therapeutic implications

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Slide 31

Slide 32

COPD Assessment Test (CAT) A CAT score over 10 suggests

significant symptoms

A change in CAT score of 2 or more suggests a possible change in health status

A worsening of CAT score could be explained by an exacerbation, poor medication adherence, poor inhaler technique, or progression of COPD or comorbid condition. An adjustment in therapy may be needed.

mMRC Breathlessness Scale

Chris Stenton. The MRC breathlessness scale. Occup Med (Lond)(2008)58(3): 226-227 doi:10.1093/occmed/kqm162, Table 1. By permission of Oxford University Press on behalf of the Society of Occupational Medicine.

Grade Description of Breathlessness 0 I only get breathless with strenuous exercise

1 I get short of breath when hurrying on level ground or walking up a slight hill

2 On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace

3 I stop for breath after walking about 100 yards or after a few minutes on level ground

4 I am too breathless to leave the house or I am breathless when dressing

Pulmonary Rehabilitation Improves CRQ Dyspnea

Lacasse et al, Cochrane Database of Systematic Reviews 2006; Issue 4; Art. No.: CD003793

4 2 2 4

Behnke 200a Cambach 1997

Favors Control Favors treatment

Goldstein 1994

Mean Difference (95% CI)

2.26 (1.34, 3.18) 1.20 (0.36, 2.04) 0.66 (0.12, 1.20)

0

Gosselink 2000 Griffiths 2000 Gell 1995

0.82 (0.17, 1.47) 1.18 (0.85, 1.51) 1.30 (0.64, 1.96)

Gell 1998 Hernandez 2000 Simpson 1992

1.00 (0.20, 1.80) 0.78 (0.02, 1.54) 1.20 (0.37, 2.03)

Singh 2003 Wijkstra 1994 Total

0.88 (0.35, 1.41) 0.90 (0.13, 1.67) 1.06 (0.85, 1.26)

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Treadmill Endurance Time Improves With Combination Tiotropium and Pulmonary Rehabilitation

Randomized to Tiotropium or Placebo

Casaburi et al. Chest. 2005;127:809-817 (A).

8

10

12

14

16

18

20

22

24

0 4 14 24

Pulmonary rehabilitation

Tiotropium

Randomization Placebo

* *

Endu

ranc

e Ti

me

(min

utes

)

Weeks of Treatment *P<0.05

Regular symptoms

Severity Domain 3. Exacerbations yHigh Risk: y Two or more exacerbations in past year y Especially if FEV1<50% predicted

yHigh risk for exacerbations has therapeutic implications

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Impact of Exacerbations in COPD

Wedzicha JA, Seemungal TA. Lancet. 2007;370:786-796.

Patients With Frequent Exacerbations

Higher Mortality

Faster Decline in Lung Function

Poorer Quality of Life

Greater Airway Inflammation

Faster Decline in Lung Function

AECOPD and Airflow Obstruction

Hurst JR et al. NEJM 2010;363:1128-38 (ECLYPSE)

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ECLIPSE: Factors Associated with Increased Exacerbation Frequency

Adapted from Hurst JR, et al. N Engl J Med. 2010;363:1128-1138.

Management of Acute Exacerbations in COPD

Oxygen as needed Maximize bronchodilator therapy Add systemic steroids if baseline FEV1<50%

predicted Add antibiotics in patients with 2 or more

symptoms: worsening dyspnea, increased sputum volume, increased sputum purulence

Consider noninvasive ventilation (NIPPV) in severe exacerbations to minimize need for intubation and ventilator support

COPD Exacerbations Preventive Measures

Smoking cessation Long acting

bronchodilators Inhaled corticosteroids Phosphodiesterase

inhibitors Mucolytics/Antioxidants Immunizations-

influenza vaccine

Macrolides Pulmonary

Rehabilitation Lung Volume

Reduction Surgery Augmentation therapy

in Alpha 1 deficiency Beta blockers…Statins Case Management

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Slide 44

Period

160

120

80

40

0 Influenza 1 Influenza 3 Influenza 2 Interim 1 Interim 2

Vaccinated

Unvaccinated

Nichol et al. Ann Intern Med. 1999;130:397.

Res

pira

tory

Hos

pita

lizat

ions

/ 10

00 P

atie

nt-Y

ears

Prevention of COPD Exacerbations:

Influenza Vaccination

ICS/LABA decreases AECOPD c/w LABA

Nannini et al, Cochrane Database of Systematic Reviews 2007; Issue 4; Art. No: CD006829

0.5 0.7 1.5 2.0

Kardos 2007 TORCH

Favors ICS/LABA Favors LABA

Subtotal

Odds Ratio (95% CI)

0.65 (0.56, 0.75) 0.88 (0.81, 0.96)

0.84 (0.78, 0.89)

FP/SCM

Calverley 2003 Szafranski 2003

0.75 (0.59, 0.94) 0.77 (0.60, 0.99)

BDF

0.5 0.7 1.5 2.0

TRISTAN 0.93 (0.81, 1.08)

Subtotal 0.76 (0.64, 0.90)

ICS/LABA Added to Tiotropium Decreases Exacerbation Rate in at Risk COPD Patients

0.2 0.4 0.6 0.8 1 1.2 1.4 0 1.6 1.8 2.0

Severe AECOPD

Hosp/ER

Favor Bud/form +tio

Favor Pbo +tio

Welte et al, AJRCCM 2009; 180: 741-50

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MACRO Study y Once daily azithromycin in addition to usual care y Decreased frequency of AECOPD y 1.48 vs 1.83 /patient-year p=0.01, HR for acute

exacerbation per patient year -0.73. y Median time to first exacerbation 266 days vs 174

days p<0.001 y Improved quality of life of exacerbation prone

COPD patient y Hearing loss more common-25%vs20%

Albert et al NEJM 2011;365,8:689-698

High Dose NAC Decreases COPD Exacerbations

N-acetylcysteine (NAC) is a mucolytic agent with antioxidant activity.

Pantheon study: 1006 patients with COPD. NAC 600 mg bid decreased exacerbations by

22%. Reduced exacerbations greater (29%) in ICS

naïve. Reduced exacerbations greater (39%) in GOLD II Excellent safety profile

Zheng JP et al ERS P3394 Sept 2013

Exacerbations

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Severity Domain 4. Oxygenation • Oxygenation should be checked in

symptomatic patients with SG2/3 • Severe hypoxemia: resting O2 sat <88% or

arterial pO2<55 mmHg • Episodic hypoxemia: exercise or nocturnal

desaturation • Severe hypoxemia has therapeutic implications • Episodic hypoxemia may have therapeutic

implications

Effect Of LTOT In Patients With Severe Hypoxemia

Cranston et al. Cochrane Syst Rev. 2008; Vol 4

Continuous O2 better

Patients, n

NOTT, 1980 203 0.45 (0.25, 0.81)

MRC 1981 87 0.42 (0.18, 0.98)

0.1 0.2 0.5 2 5 10

Study Peto Odds Ratio (95% CI)

1 No O2 better

LTOT vs nocturnal O2 PaO2 < 55 or 59 mmHg

LTOT vs no O2 PaO2 40-60 mm Hg

Oxygenation

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Severity Domain 5. Emphysema • Presence of emphysema should be

evaluated in patients with SG3 • Reduced density on CT scan • Can be diffuse or localized • Abnormal high lung volumes • Abnormal low diffusion capacity • Localized emphysema particularly localized

to upper lung zones could have therapeutic implications

Lung Volume Reduction Surgery is Appropriate in Subgroups Of COPD

All Patients N = 1218

High Risk Patients N = 140

Non High Risk Patients N = 1078

Upper Lobe High Exercise

N = 419

Upper Lobe Low Exercise

N = 290

Non Upper Lobe Low Exercise

N = 149

Non Upper Lobe High Exercise

N = 220

LVRS

LVRS

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Emphysema

Severity Domain 6. Chronic Bronchitis

• Cough, sputum most days for at least 3 months in at least 2 years

• Presence of chronic bronchitis has therapeutic implications

Reduction In COPD Exacerbations* in Severe COPD, Chronic Bronchitis and a History of Exacerbation

- 16.9%

0

0.5

1

1.5

1.374 1.142

n: 1554 1537 Roflumilast Placebo

Calverley PMA, Rabe,KF, Goehring, UM et al. Lancet 2009;374:685–694.

(CI -25;-8) p = 0.0003

* Moderate to severe exacerbations

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Changes in Frequent Exacerbator Group 32% of Frequent exacerbators treated with roflumilast remained

Frequent exacerbators, while 68% became Infrequent exacerbators

Wedzicha W, et al. Chest 2013; 143: 1302-11

Exacerbations frequency at year 0 (Exacerbations in the last 12 months)

Roflumilast – frequent exacerbators

Placebo – frequent exacerbators

Frequent exacerbators (2 or more exacerbations/year)

Per

cent

age

of p

atie

nts

0

20

40

60

80

26.8 26.9

Exacerbations frequency at year 1

Percentage of patients

Risk ratio = 0.799, P=0.0148 Frequent exacerbators

80 60 40 20 0

0

1

≥2 N

umbe

r of e

xace

rbat

ions

32.0 40.8

Infrequent exacerbators

27.8 25.4

40.2

33.8

Roflumilast – infrequent exacerbators

Placebo – infrequent exacerbators

Chronic Bronchitis

Severity Domain 7. Comorbidities

• Comorbidities are extremely common in COPD and impact morbidity, hospitalization and re-hospitalization rates and mortality.

• Evidence suggests that COPD may be an independent risk factor for the development of cardiovascular disease, lung cancer, depression, osteoporosis.

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Severity Domain 7. Comorbidities

• Defining and treating comorbid conditions, particularly cardiovascular, are critical components of COPD care.

Total Number of CoMorbidities

p <0 .001

19%

47%

27%

6%1%

30%

53%

14%

2% 0%0%

10%

20%

30%

40%

50%

60%

1 - 5 6 - 10 11 - 15 16 - 20 20 - 25

Household (N=1,003) Patient Org (N=2,029)

Barr et al AmJMed 2009;122,348-355

Impact of Comorbidities on COPD Mortality

0% 20% 40% 60% 80% 100%

Severe COPD

Moderate COPD

Normal Lungs

COPD ASCVD Lung Cancer Pneum/Inf Other

Mannino et al, Thorax, 2003

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Slide 65

COPD & Comorbidities

Barnes PJ. PLoS Med 2010;7:e1000220.

Am J Respir Crit Care Med. 2012; 186:155-61

Comorbidities

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COPD 2014 Almost always preventable

Almost always treatable

Prevent and treat exacerbations

To treat COPD need to address comorbid conditions

Patient centered vs Disease centered care

COPDfoundation.org

Page 26: Guidelines-Based COPD Management

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TEST

Guidelines-Based COPD Management AARC Professor’s Rounds 2014 – Program 8

Mark the Corresponding Box for your Response to each Question

7 Correct Out of 10 is Passing Name: __________________ _____________________ AARC Mbr #: _______________ (first) (last) Email Address:___________________________________ Date: _____________________ (required for nonmembers) 1. COPD is the nation’s fifth leading cause of death and third leading cause of disability.

o True o False 2. All COPD patients present with the same severity.

o True o False 3. Using spirometric values can help differentiate COPD from asthma.

o True o False 4. Patients with frequent exacerbations of COPD may demonstrate a faster decline in lung function, poorer

quality of life, higher mortality, and greater airway inflammation. o True o False 5. When assessing for risk, choose the highest risk according to GOLD grade or exacerbation history.

o True o False

6. SG 2 is consistent with the most severe presentation of COPD based on FEV1/FVC ratio. o True o False

7. A COPD Assessment Test (CAT) score over 10 suggests significant symptoms.

o True o False 8. Lung volume reduction surgery may be appropriate for some subgroups of COPD.

o True o False 9. All published COPD guidelines utilize the same methodology and rigor in literature.

o True o False 10. Guidelines often do not take other guidelines into account.

o True o False

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PARTICIPANT EVALUATION

Guidelines-Based COPD Management AARC Professor’s Rounds 2014 – Program 8

Please help evaluate this program by taking a moment to answer the following questions. Thank you.

1. My current position is:

_____Staff Therapist _____RT Supervisor/Mgr _____Student _____RT Program Faculty

_____Other (please specify) ________________________________________________ 2. The content of today’s program was relevant and applicable to my job.

_____Strongly Disagree _____Disagree _____Neutral _____Agree _____Strongly Agree 3. Presenters were easily understood and presented the topic well.

_____Strongly Disagree _____Disagree _____Neutral _____Agree _____Strongly Agree 4. Slides on the video were effective in supporting the information presented.

_____Strongly Disagree _____Disagree _____Neutral _____Agree _____Strongly Agree 5. I achieved the learning objectives of today’s program.

_____Strongly Disagree _____Disagree _____Neutral _____Agree _____Strongly Agree 6. Provide any comments you have about this program:

7. List any topics that you would like to see presented as future programs.

Participants: Please return this completed form to your Proctor/Site Coordinator.