Educational Outcomes Report...Grant # 8060 Accredited provider of medical and professional education...

EducationalOutcomes Report

July 22, 2011

Grant # 8060

Accredited provider of medical and professional education

8201 W McNab Road, Tamarac, FL 33321 Phone: (954) 718-6055 Fax: (954) 718-6013 www.primeinc.org

Copyright © 2011 PRIME Education, Inc. All Rights Reserved.

This program was sponsored by PRIME® through an independent educational grant from Teva Neuroscience.

Educational Outcomes Report: Highlights in Multiple Sclerosis Treatment from the 2011 AAN Meeting 2Copyright © 2011 PRIME Education, Inc. All Rights Reserved.

Grant #8060

Table of ContentsExecutive Summary and Program Description ....................................................................................................... 3

Expert Faculty ...................................................................................................................................................................... 5

Level 1: Participant Demographics ............................................................................................................................. 6

Level 2: Participants’ Assessments of the Educational Activity ......................................................................... 6

Level 3: Knowledge Outcomes ...................................................................................................................................... 11

Continuous Needs Assessment .................................................................................................................................... 13

Summary, Conclusions, and Future Directions ....................................................................................................... 15

Appendix:

Educational Needs Assessment, Activity Development, and Outcomes Assessment at PRIME®: Ap-

plications of Established Conceptual Frameworks and Principles of Adult Learning ............................... 16


Grant #8060

Executive Summary and Program DescriptionThe medical management of patients with multiple sclerosis (MS) continues to undergo rapid evolution. While injectable disease-modifying therapies (DMTs) for MS have been the treatment mainstay over the last two decades, the first oral DMT for MS was approved by the FDA in 2010. In addition, other oral agents, as well as targeted monoclonal antibodies, are currently in late stages of clinical development. Thus, the coming months and years promise exciting changes as well as ongoing challenges for neurology practices. Continuing education about the efficacy and risks of emerging MS therapies is pivotal meeting these challenges and for ensuring optimal outcomes for patients. To address the current knowledge needs of neurology-based MS care providers, PRIME® sponsored a series of educational programs that highlighted key research findings from the 63rd annual meeting of the American Academy of Neurology (AAN), which was held in Honolulu in April 2011. Intended for neurologists and their treatment teams, the programs presented the most up-to-date information on new agents for MS and their potential role in the MS management paradigm.

This document reports the outcomes of the PRIME®-sponsored educational series on the 2011 AAN meeting. The body of the report is organized by distinct levels of educational outcomes, with focused assessments of:

• Participant demographics

• The teaching effectiveness of the faculty

• The quality of the learning experience

• Activity-influenced gains in understanding and confidence

Explanations of these outcome domains, along with their evidence-based rationale, are presented in the appendix document titled Educational Needs Assessment, Activity Development, and Outcomes Assessment at PRIME®: Applications of Established Conceptual Frameworks and Principles of Adult Learning.


Grant #8060

1.5 Hours LIVE CME

There is no fee for this activity as it is sponsored by PrIME® through an independent educational grant from Teva Neuroscience.

Stephen Krieger, MD Assistant Professor of Neurology Mount Sinai Medical Center Corinne Goldsmith Dickinson Center for MS Mount Sinai Hospital New York, NY

Clyde E Markowitz, MD Director Multiple Sclerosis Center University of Pennsylvania Associate Professor of Neurology University of Pennsylvania School of Medicine Philadelphia, PA

Robert A Bermel, MD Associate Staff Mellen Center for Multiple Sclerosis Cleveland Clinic Cleveland, OH

Aaron E Miller, MD Medical Director Corinne Goldsmith Dickinson Center for Multiple Sclerosis Professor of Neurology Mount Sinai School of Medicine New York, NY Lansing, MI

Omar Khan, MD Professor of Neurology Director, Wayne State University Multiple Sclerosis Center Director, MR Image Analysis Laboratory Program Director, Neuroimmunology and Multiple Sclerosis Fellowship Wayne State University School of Medicine, Detroit Director, National MS Society Comprehensive Care Multiple Sclerosis Clinic Harper University Hospital, The Detroit Medical Center Detroit, MI

Burk Jubelt, MD Professor of Neurology Division Chief, Neurology Department of Neurology at SUNY Upstate Medical University Syracuse, NY

Guy J Buckle, MD, MPH Director of MS Clinical Care Partners Multiple Sclerosis Center Brigham and Women’s Hospital Assistant Professor of Neurology Harvard Medical School Boston, MA

Claire S Riley, MD Instructor in Neurology Yale MS Center New Haven, CT

Tom Scott, MD Director Allegheny Multiple Sclerosis Treatment Center Professor of Neurology Director of the Medical Residency Training Program and Medical Student Clerkship Allegheny General Hospital Drexel University College of Medicine Pittsburgh, PA

Carlo Tornatore, MD Associate Professor Department of Neurology Director, Multiple Sclerosis Center Georgetown University Hospital Director, Neurology Residency Program Director, Neurology Clerkship Georgetown University Medical Center Washington, DC

Warren L Felton III, MD Chair Division of Neuro-Ophthalmology Virginia Commonwealth Medical Center Richmond, VA

Fred D Lublin, MD Saunders Family Professor of Neurology Director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis Mount Sinai School of Medicine New York, NY

Susan Gauthier, DO, MPH Assistant Professor of Neurology Assistant Attending Neurologist NewYork-Presbyterian Hospital Feil Family Clinical Scholar in Multiple Sclerosis Weill Cornell Medical College

Registration web page

Program Title:

Highlights in Multiple Sclerosis Treatment from the 2011 AAN Meeting

Accreditation:

1.5 ACCME, AANP

Print invitation (Front)

Print invitation (inside)

Learning ObjectivesNewest evidence in emerging therapies in MS as presented at AAN ÂUtility of new therapies in MS treatment in the absence of guidelines ÂComplications of managed care in the absence of guidelines ÂPotential changes to neurology practice in monitoring patients who are receiving Ânewer therapies

v

Intended Audience: Physicians, physician assistants, and nurse practitioners

Accreditation StatementsPhysician Accreditation Statement

PRIME Education, Inc. (PRIME®) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

PRIME® designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Physician Assistant Accreditation StatementAAPA accepts AMA Category 1 CME Credit™ for the PRA from organizations accredited by ACCME.

Nurse Accreditation StatementPRIME Education, Inc. (PRIME®) is accredited by the American Academy of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 060815. This

program is accredited for 1.5 contact hours, which includes 1.0 hour of pharmacology. Program ID# 35LV1100AAN.

This program was planned in accordance with AANP CE Standards and Policies and AANP Commercial Support Standards.PRIME® designates this activity for 1.5 contact hour.

CME/CE credit awards require attendance at the entire program and completion of learner assessment tools, after which the learner can print a certificate of completion.

Register Online at: www.primeinc.org/AAN

Registration & Dinner commence at 6:30 PMEducational Program: 6:45 PM – 8:15 PM

Locations Invited Expert Faculty

BaltimoreCinghiale

Baltimore, MD 21202Carlo Tornatore, MD

RichmondMorton’s

Richmond, VA 23219Warren L Felton III, MD

SyracuseArad Evans Inn

Fayetteville, NY 13066Burke Jubelt, MD

BostonMorton’s

Boston, MA 02116Guy J Buckle, MD, MPH

ProvidenceCamille’s

Providence, RI 02903Syed A Rizvi, MD

HartfordMorton’s

Hartford, CT 06103Claire S Riley, MD

Worcester111 Chop House

Worcester, MA 01604James M Stankiewicz, MD

Birmingham, MIThe Townsend Hotel

Birmingham, MI 48009Omar Khan, MD

Lansing, MIMitchell’s Fish Market

Lansing, MI 48912Omar Khan, MD

ClevelandHyde Park Prime

Cleveland, OH 44115Robert A Bermel, MD

ColumbusLindey’s

Columbus, OH 43206Aaron L Boster, MD

Manhattan (NYC)Morton’s

New York, NY 10176Stephen Krieger, MD

Long IslandBlackstone

Melville, NY 11747Lauren B Krupp, MD

West OrangeHighlawn Pavilion

West Orange, NJ 07052Stuart Fox, MD

RochesterWoodcliffe Hotel

Fairport, NY 14450Susan Gauthier, DO, MPH

PittsburghMorton’s

Pittsburgh, PA 15222Tom Scott, MD

PhiladelphiaUnion Trust

Philadelphia, PA 19106Clyde E Markowitz, MD

ArlingtonMorton’s

Arlington, VA 22202Carlo Tornatore, MD

* Parking fees are the responsibility of the attendee.

Conflict of interest information is available on the program registration page at www.primeinc.org.

PRIME® is committed to providing access to our CME programs for individuals with disabilities as identified in Title III of the American with Disabilities Act (ADA) for live programs. If you use assistive technology (ie, Braille reader, screen reader, TTY) and the format of any material on the PRIME® website’s program registration pages, CME test/evaluation pages, or other areas interfere with your ability to access the information, please contact [email protected] or 954-718-6055 for assistance.

Program Dates & Locations:

April 25, 2011 West Orange, NJ

May 4, 2011 Philadelphia, PA

May 5, 2011 Cleveland, OH

May 11, 2011 New York, NY

May 12, 2011 Fayetteville, NY

May 16, 2011 Providence, RI

May 17, 2011 Boston, MA

May 23, 2011 Richmond, VA

May 23, 2011 Baltimore, MD

May 24, 2011 Rochester, NY

June 6, 2011 Pittsburgh, PA

June 7, 2011 Columbus, OH

June 8, 2011 Arlington, VA

June 9, 2011 Hartford, CT

June 13, 2011 Melville, NY

June 14, 2011 Lansing, MI


Grant #8060

Expert Faculty Robert Bermel, MDAssociate StaffMellen Center for Multiple SclerosisCleveland ClinicCleveland, OH

Aaron Boster, MDAssistant Professor of NeurologyDivision of ImmunologyOhio State University Multiple Sclerosis CenterCo-Director, Neurology Infusion CenterDirector, Multiple Sclerosis Center Clinical ResearchMoorehouse Multiple Sclerosis CenterColumbus, OH

Guy Buckle, MD, MPHDirector of MS Clinical Care Partners Multiple Sclerosis CenterBrigham and Women’s HospitalAssistant Professor of NeurologyHarvard Medical SchoolBoston, MA

Eric Eggenberger, DO, MSEpi, FAANProfessor, Vice-Chairman, Department of Neurology and Ophthalmology, Colleges of Osteopathic Medicine and Human MedicineDirector, Michigan State University Ocular Motility LaboratoryDirector, National Multiple Sclerosis Society Clinic, Michigan State UniversityEast Lansing, MI

Warren Felton, MDChairDivision of Neuro-OphthalmologyVirginia Commonwealth Medical CenterRichmond, VA

Andrew Goodman, MDProfessor of NeurologyDirector, Multiple Sclerosis CenterChief, Neuroimmunology UnitDepartment of NeurologyUniversity of Rochester Medical CenterRochester, NY

Stephen Krieger, MDAssistant Professor of NeurologyMount Sinai Medical CenterCorinne Goldsmith Dickinson Center for MSMount Sinai HospitalNew York, NY

Burk Jubelt, MDProfessor of Neurology, Microbiology/Immunology and Neuroscience Division Chief, NeurologyDepartment of Neurology at SUNY Upstate Medical UniversitySyracuse, NY

Fred Lublin, MDSaunders Family Professor of NeurologyDirector, The Corinne Goldsmith Dickinson Center for Multiple SclerosisMount Sinai School of MedicineNew York, NY

Clyde Markowitz, MDDirectorMultiple Sclerosis CenterUniversity of PennsylvaniaAssociate Professor of NeurologyUniversity of Pennsylvania School of MedicinePhiladelphia, PA

Aaron Miller, MDMedical DirectorCorinne Goldsmith Dickinson Center for Multiple SclerosisProfessor of NeurologyMount Sinai School of MedicineNew York, NY

Claire Riley, MDAssistant ProfessorYale School of MedicineNeurology Multiple Sclerosis and NeuroimmunologyNew Haven, CT

Robert Shin, MDAssociate Professor of NeurologyAssociate Professor of Ophthalmology and Visual SciencesUniversity of Maryland School of MedicineBaltimore, MD

Carlo Tornatore, MDAssociate ProfessorDepartment of NeurologyDirector, Multiple Sclerosis CenterGeorgetown University HospitalDirector, Neurology ResidencyProgram Director, Neurology ClerkshipGeorgetown University Medical CenterWashington, DC


Grant #8060

Level 1: Participant Demographics 293 Registered Attendees

239 Program Participants

102 Earning CME/CE Credit

By discipline, the distribution was as follows:

• 160 Neurologists/Immunologists

• 22 Nurse Practitioners

• 14 Physician Assistants

• 43 Specialty Nurses

*The intended audience for this grant was 15 neurologists, nurse practitioners, physician assistants and specialty nurses at each CME activity. Therefore, the grant goals of intended audience mix and audience size were met.

Level 2: Participants’ Assessments of the Educational ActivityFollowing the educational activity, participants evaluated various aspects of its effectiveness and accessibility. PRIME® uses these outcomes to determine the extent to which its activities fill identified educational gaps and address critical learning objectives. In addition, participants’ assessments of educational activities inform our future needs assessments and curriculum development. Evaluations were completed by 102 participants.

To assess participants’ views on the value of CME, we asked the following question on a post-activity survey:

To what extent do CME activities like this one provide greater value to your clinical practice than promotional programs?

a. Limited additional value

b. Moderately greater value

c. Significantly greater value

As illustrated in Figure 1, the majority of participants (54%) stated CME activities

Figure 1. Participants’ self-reported value of CME activities vs. promotional programs to their clinical practice.

8%

38%

54%

0%

10%

20%

30%

40%

50%

60%

Limited value Moderate value Significant valuePa

rtici

pant

s Cho

osin

g Re

spon

se (%

)

Reported Immediately After Activity


Grant #8060

provide significantly greater value to their clinical practice than promotional programs.

Effectiveness in Meeting Learning Objectives

This educational activity was designed to support participants in achieving the following learning objectives.

1. Summarize new science and evidence from the AAN 2011 meeting pertaining to multiple sclerosis therapy

2. Debate the relative utility of new therapy in the MS treatment paradigm in the absence of guidelines

3. Evaluate changes to practice that may be required to effectively monitor patients receiving newer therapies

Participants assessed the educational activity’s effectiveness in meeting the learning objectives. On a 5-point scale (with 5 indicating the highest ranking), the combined mean average was 4.6 (Figure 2).

Figure 2. Participants’ assessments of how effectively the educational activity met its learning objectives.

4.6

4.5

4.7

1 2 3 4 5

Learning objective #3



Average Ratings


Grant #8060

Participants assessed the educational activity’s effectiveness in meeting the learning objectives. On a 5-point scale (with 5 indicating the highest ranking), the combined mean average was 4.6 (Figure 2).

Faculty Ratings

Figure 3 presents participants’ ratings of the knowledge, expertise, and presentation skills of the faculty. On a 5-point scale (with 5 indicating the highest rating), the average rating for these measures of faculty teaching effectiveness was 4.9.

Additional Participant Ratings

As illustrated in Figure 4, participants gave high ratings of the educational activity’s accessibility, time allotment, rigor, and adherence to adult learning principles.

Figure 3. Participants’ assessments of faculty teaching effectiveness. Rating scale: 1 = lowest rating; 5 = highest rating.

Figure 4. Participants’ assessments of the accessibility, effectiveness, and rigor of the educational activity. Rating scale: 1 = lowest rating; 5 = highest rating.

4.9

4.8

4.9

1 2 3 4 5

Knowledge andexpertise

Ability to conveysubject matter

effectively

Ability to deliverobjective and balanced

program

Average Ratings

4.6

4.7

4.8

4.7

4.7

1 2 3 4 5

Time allotted forprogram

Principles of adultlearning

Registration process

Scientific rigor

User friendliness

Average Ratings


Grant #8060

Fair Balance

In a post-activity questionnaire, 100% of participants indicated that the educational content was objective and unbiased.

Participants’ Open-Ended Comments

In an online survey delivered following the educational activity, participants were given the opportunity to comment freely on its strengths and weaknesses. Representative comments are reproduced as follows.

This program provided the best overall assessment of current therapies for multiple sclerosis of the many programs over the years. — Physician

An informative, well-organized program. An outstanding speaker with both extensive clinical experience and up-to-date scientific knowledge with the rare ability to make esoteric research data both meaningful and easy to understand. — Physician

This is one of the best CME lectures I’ve been to. The speaker is excellent! - Physician

An excellent overview of MS treatments, and it’s exciting to learn about “pipeline” drugs. — Nurse Practitioner

The program was very informative but needed additional time — Physician

This program fit my needs perfectly with regard to the timeliness of the information and how easily it was for me to fit it into my work schedule. It provided me CME credits instead of just being a marketing tool for a particular product. — Physician

As usual this was an excellent program. The speaker was exceptional, the reminders via email & phone helped to fill the room, and many participants commented on how helpful the reminders were. Keep up the good work. — Specialty Nurse

A great program, but the venue and food were not that great. — Physician

A fantastic program, great venue, well-organized, and very comfortable. — Physician

A lot of material was covered in a short period of time. I appreciated having the slide deck ahead of time. — Nurse Practitioner

The program was excellent. The speaker is an excellent presenter and very knowledgeable. The room was too small and the restaurant staff was not prepared for the amount of people who attended the program. There should be a wider range of food choices. Servers were very unprofessional and rude. — Specialty Nurse

I learned a great deal about the new science and evidence from the AAN 2011 meetings from this program. — Physician

An excellent program given at an excellent time due to current circumstances and changes in practice at the various neurology offices. — Specialty Nurse

A nice way to have “attended” the AAN in Hawaii with respect to MS. I would have liked updates on diagnosis, especially biomarkers. — Physician

I loved the way the speaker presented the data. Very informative and I learned more from this than any of the other MS CME I have attended — Physician

The speaker is obviously very well informed regarding MS, and I thought he gave both the pros and cons of the drug regimens. — Nurse Practitioner

A great deal of material was summarized in the time allotted. Perhaps either less material could have been reviewed, or a longer period of time could have been allotted for the lecture. — Physician

The speaker is very clear, concise, and his explanation was very informative. Staff members were very helpful and professional. — Physician

A very nice presentation. The speaker did an excellent job (as always). — Physician


Grant #8060

The speaker is outstanding, very well informed. I took away a tremendous amount from this program. — Nurse Practitioner

The room was too small with cramped space at tables. I would also like copy of slides from this presentation to review. — Nurse Practitioner

The program was excellent. The speaker is an excellent presenter. The environment was warm and friendly. — Specialty Nurse

The speaker gave a wonderful presentation. — Physician

I enjoyed and learned a great deal at this educational meeting —Physician

The room set up made it difficult to see the slides from all seats. — Specialty Nurse

A brief clinical overview of MS prior to delving into the more complex therapy regimens would have been beneficial. — Physician

The speaker was well-informed, open and encouraging of questions. An excellent opportunity. — Nurse Practitioner

The program facilitator was excellent, as was the speaker. — Physician

A summary information sheet with name of drug, action of drug, side effect, route of administration and indication when to pick over the available drugs would help. — Physician

A timely and very welcome program. — Physician

A summary handout would help as there are too many new drug names and studies to keep them all straight without a written guide. —Physician


Grant #8060

Level 3: Knowledge OutcomesBefore and after the educational activity, participants answered a series of multiple-choice questions designed to evaluate gap-targeted knowledge outcomes.

Learning Insights, Values, and Intentions to Change Practices

As reflected by the following pre-activity/post-activity questions, this sub-level of knowledge outcomes addresses the influences of educational interventions on participants’ self-reported understanding of essential topics and their confidence in performing key clinical skills. In addition, at this sub-level of knowledge outcomes, we assess learners’ activity-influenced intentions to change clinical and/or management practices.

How would you describe your current understanding of new and emerging oral therapies for MS?

a. Limited

b. Adequate

c. Good

d. Excellent

Figure 5 presents the percentages of participants reporting different levels of understanding regarding oral MS therapies. The greatest magnitudes of pre-activity to post-activity change were reported for “limited” understanding, which decreased from 44% to 16% of participants and “good” understanding, which increased from 24% to 44% of participants.

Figure 5. Participants’ self-reported understanding of new and emerging oral therapies for MS.

44%

29%

24%

3%

16%

29%

44%

11%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Limited Adequate Good ExcellentPa

rtici

pant

s Cho

osin

g Re

spon

se (%

)

Reported Prior to Activity Reported Immediately After Activity


Grant #8060

Figure 6. Participants’ self-reported understanding of new monoclonal antibodies for treating MS.

Figure 7. Participants’ self-reported confidence in discussing the benefits and risks of emerging MS therapies with their patients.

How would you describe your current understanding of new monoclonal antibodies for treating MS?

a. Limited

b. Adequate

c. Good

d. Excellent

Figure 6 presents the percentages of participants reporting different levels of understanding about monoclonal antibodies for MS. The greatest magnitudes of pre-activity to post-activity change were reported for “ limited” understanding, which decreased from 53% to 18% of participants and “good” understanding, which increased from 18% to 34% of participants.

How would you describe your current level of confidence in discussing the benefits and risks of emerging MS therapies with your patients?

a. Limited

b. Average

c. Good

d. Excellent

Figure 7 presents the percentages of participants reporting different levels of confidence in their ability to discuss the benefits and risks of emerging MS therapies with their patients. The greatest magnitudes of pre-activity to post-activity change were reported for “limited” confidence, which decreased from 48% to 19% of participants and “good” confidence, which increased from 18% to 38% of participants.

53%

26%

18%

3%

18%

36% 34%

12%

0%

10%

20%

30%

40%

50%

60%

Limited Adequate Good ExcellentPa

rtici

pant

s Cho

osin

g Re

spon

se (%

)


48%

31%

18%

3%

19%

30%

38%

13%

0%

10%

20%

30%

40%

50%

60%

Limited Adequate Good Excellent

Part

icipa

nts C

hoos

ing

Resp

onse

(%)



Grant #8060

Continuous Needs Assessment Our continuous needs assessment is based on questions that participants asked the expert faculty presenters during and after their presentations. Representative questions are listed as follows:

Is there a higher risk of cancer in patients with MS in general?

Would you treat a patient with CIS even with a clean MRI?

Would you treat RIS?

If a patient has a relatively quiet clinical course of MS in the first 3-5 years, do they have a better prognosis 20 years later?

How many people with benign MS really never have MS?

Can you comment on current CCSVI research and status in the US?

How long can a patient take dalfampridine?

What is the primary mechanism of action of laquinimod?

What is the most important side effect of alemtuzumab?

When should patients be referred to an MS specialist?

In a newly diagnosed MS patient, what are your key considerations in choosing a first line therapy?

What percentage of patients present with spinal cord lesions?

Where does the JC virus “hide” in the body?

Is teriflunomide safer in men?

Do you think cladribine will be approved?

Do you think being mentally active slows

down development of brain atrophy?

Is there a strong correlation between cognitive function and brain atrophy?

Why do some patients do not respond to dalfampridine?

Do you ever use natalizumab as a first line treatment option?

Are there current clinical trials evaluating vitamin D in MS?

How many attacks need to occur before you consider a treatment to be a “failure”?

What are the key side effects of teriflunomide?

What is important about the ratio of CD4+ and CD8+ cells?

What future medicine do you feel is going to work best in MS patients?

Where was the ocrelizumab phase II study conducted?

Where is fingolimod in your algorithm for treating patients with RRMS?

Do you have patients that you want to go on fingolimod because not doing well on an injectable agent?

How are you treating secondary progressive patients?

Aren’t there 2 forms of JCV – does the current test pick up both?

Is it possible to convert from JCV negative to positive as you age?

What would you do for your patient who has a history of immunosuppression?

Can you use atropine in patients taking fingolimod?

Why is the thyroid particularly affected by alemtuzumab?

What is the current list price of fingolimod?

Are there any predictors of survival when you get PML?

What is your general rule regarding how long to keep a patient on natalizumab?

After a drug holiday from natalizumab do you start patients on interferons or glatiramer?

Is there a cheap easy way to measure neutralizing antibodies to IFNs?

Did the researchers look at neutralizing antibodies in the REFLEX study?

When were the blood samples taken in the MS patients on natalizumab you showed in the study?

Are doctors pulling their patients off of natalizumab after two years of therapy?

Do you think drug holidays are a good idea for patients on fingolimod?

In the original trials on dalfampridine, can you describe in more detail the responder analysis?

Do you supplement your MS patients with Vitamin D?

Have you been fooled in your diagnosis with a patient that has presented with spinal cord lesions?


Grant #8060

Does dalfampridine have any significant interactions with other drugs?

How do you encourage and convince your patients to start treatment?

Will lymphocytes eventually die in patients taking fingolimod?

What was the duration of the phase III trial of teriflunomide?

Is there a direct relationship between brain atrophy and disability?

Is laquinimod being evaluated for any other diseases?

Is there any new data on adjunct therapy?

What is the average age most MS patients start clinical trials?

What is the youngest patient you have seen with MS?

How often should antibodies to IFN be assayed?

Could laquinimod be used as an add-on therapy?

Who is an ideal candidate for laquinimod?

Can you comment on whether you think the dosing of cladribine could be adjusted to be safer?

Is there any truth to the hypothesis that sugar substitutes may cause MS?

Can teriflunomide be used for primary progressive MS?

Are black holes evaluated in clinical trials of oral agents?

What type of release forms do patients have to sign before entering a clinical trial?

Is the reduction of relapse rates better with any of the oral agents?

Is natalizumab ever used as a first line agent?

Do you think in the future we will almost exclusively use oral agents?

How long does it take to show a response on dalfampridine?

Do any clinical trials evaluate patients with severe disability as measured on EDDS?

What are the main safety risks with dalfampridine?

How frequently would you test patients for JCV while they were taking natalizumab?

Have you placed any of your newly diagnosed patients on fingolimod?


Grant #8060

Summary, Conclusions, and Future DirectionsPresented immediately in the weeks following the 2011 AAN annual meeting, this series of educational programs highlighted the most up-to-date and important findings from studies on approved, new, and emerging MS therapies. The programs were attended by nearly 250 neurology-based health professionals, including 160 neurologists/immunologists.

The main outcomes of the educational activity are summarized as follows.

• More than half (54%) of all attendees responded that the CME activity provided greater value to their clinical practice than did promotional programs; 38% identified the CME program as providing “moderate value” over promotional programs.

• Attendees open-ended comments provided revealing attitudes about the CME activity including:

• Many reported that the dinner program was an efficient and effective way for them to be updated on AAN without costing time and travel to attend the Hawaii meeting

• There were complaints about the size of the venue rooms and the lack of syllabi – two areas directly affected by the reduced budget awarded to PRIME. While the quality of the content and recruitment efforts remains consistently high, lesser funding is affecting banquet services and handouts.

• There were many opt-in comments about the strength and preparation of the faculty.

• Participants gave high ratings for the teaching effectiveness of the faculty and the extent to which the learning objectives were successfully achieved.

• In open-ended comments, a large number of participants commended the topical relevance of the educational program.

• As assessed through pre-activity/post-activity survey questions, many participants reported gains in understanding about emerging oral therapies and monoclonal antibodies for MS. In addition, participants reported gains in their confidence in educating patients about the risk-benefit profiles of the emerging medications.

As reflected by the representative questions that participants asked the faculty presenters, participants expressed great interest in learning more about how the new and emerging MS therapies may eventually fit into future treatment algorithms.

60-day post-impact data for this program can be provided upon request.


Grant #8060

Laurence Greene, PhD

Senior Medical Writer, PRIME Education, Inc.

Chris R Prostko, PhD

Scientific Program Director, PRIME Education, Inc.

Established in the 1970s, the field of continuing medical education (CME) addresses the concern that the last 30 to 40 years of physicians’ and other healthcare providers’ careers may occur without any formal course of study.1,2 This issue is currently compounded by several factors, including (1) ongoing advancements in biomedical science and technology; (2) the continual development of novel therapies for emerging diseases; (3) evolution of models for collaborative and interprofessional medical practices; and (4) major changes in the infrastructure of our healthcare system. Indeed, the knowledge and skills that healthcare professionals acquire during their formative education may be obsolete within a matter of years or, in some cases, even months. To ensure the most successful outcomes for their patients, healthcare professionals must therefore engage in progressive, high-quality, and career-long education and skill training. Thus, CME can be an important element in continuing professional development.

In serving the vital mission of continuing education (CE) and CME for healthcare professionals, PRIME Education, Inc. (PRIME®) operates on established conceptual frameworks and sound principles of adult learning. This article describes PRIME®’s theory-guided and evidence-based processes for educational needs assessment, activity development, and outcomes assessment. The processes are summarized in the schematic overview in Figure 1.

Educational Needs Assessment and Activity Development Informed by Gap AnalysisThe success of any CME/CE activity depends on an initial comprehensive assessment of learners’ needs.3,4 A logical and productive approach to needs assessment is gap analysis, the systematic process of identifying differences between:

(1) The healthcare professional’s current knowledge, competence, and performance skills; and

(2) Established standards and criteria that must be achieved to promote the highest quality clinical performance and optimal patient outcomes.

As depicted in steps 1 and 2 of Figure 1, gap analysis directly informs the development of learning objectives for educational activities. Gap analysis is also fundamental to devising the methods and tools for outcomes assessment and for developing effective curricular strategies, media, and content. PRIME® operates on the principle that these two processes—the design of outcomes methodology and the development of educational activities—must be tightly integrated. This complementary approach, depicted in steps 3 and 4 of Figure 1, is essential for serving learners’ needs and ensuring successful outcomes of CME/CE activities.

Principled Approaches to Outcomes AssessmentToday’s leading approaches to outcomes assessment in CME/CE have been largely shaped by conceptual frameworks developed by Donald Kirkpatrick,5 George Miller,6 and Donald Moore and colleagues.7 Among other shared features these frameworks are based on the principle that the highest goals of adult education are achieved when learners successfully apply new knowledge to solve problems and master skills in their practice settings. Thus, outcomes assessment in CME/CE must account for the extent to which health professionals:

(1) Acquire essential information, ideas, and procedural skills that target identified gaps and serve an educational activity’s learning objectives;

(2) Demonstrate competent applications of the knowledge within the educational setting; and

(3) Skillfully transfer the newly acquired knowledge to practical settings, effectively closing the gaps that initially motivated the educational intervention.

PRIME®’s pyramid model of outcomes assessment, adapted largely from the recently refined framework of Moore et al,7 is presented in Figure 2. The base of the pyramid represents outcomes of participant demographics (level 1) and participants’ assessments of the quality and effectiveness of educational activities (level 2). Level 2 assessments are implemented through post-activity questionnaires in which participants rate the effectiveness, scientific rigor, and objectivity of the curriculum as well as the knowledge, expertise, and presentation skills of the faculty. In PRIME®’s continuous assessment model, data derived from level 2

Educational Needs Assessment, Activity Development, and Outcomes Assessment at PRIME®: Applications of Established Conceptual Frameworks and Principles of Adult Learning


Grant #8060

Figure 1. An overview of PRIME®’s approach to needs assessment, educational activity development, and outcomes assessment. Post-activity assessments (steps 9 and 10) are conducted immediately following educational programs and up to 60–180 days later.


Grant #8060

evaluations are essential for guiding future gap analyses and for informing the development of new educational activities that enable learners to achieve higher levels of knowledge, competence, and performance. These applications are reflected in the feedback loop from steps 9 and 10 to step 1 in Figure 1.

At level 3 of PRIME®’s pyramid model, pre-activity and post-activity tests are administered to assess changes in declarative (factual) knowledge and procedural knowledge, the latter of which is defined as an expressed understanding of the steps involved in carrying out healthcare practices. Learners’ gains in declarative and procedural knowledge are obviously prerequisites to improving performance skills and, ultimately, to ensuring successful patient health and community health outcomes. This pivotal role of core knowledge is especially pertinent for contemporary healthcare professionals, who continually face the challenges of grasping complex new information and techniques in the biomedical sciences. In addition to assessing learners’ declarative and procedural knowledge acquisition, PRIME® evaluates the extent to which CME/CE activities influence self-reported learning insights, values, and behaviors. Outcomes are assessed, for example,

on the influences of CME/CE interventions on participants’ attitudes about educational topics, their intentions to change practices in ways that meet established standards, and their subsequent self-directed learning behaviors. Positive changes in these important subjective learning domains are very often correlated with improved clinical performance and a deeper engagement in lifelong education.8-10

In keeping with the recent outcomes framework developed by Moore et al,7 PRIME® defines competence (level 4) by how successfully learners apply knowledge within the context of an educational activity. For healthcare professionals, gains in competence are thus reflected by such actions as direct applications of knowledge to diagnosing disease; selecting, administering, and adjusting therapies; and counseling and monitoring patients to ensure medication adherence and to prevent medication-related problems. In live and web-based educational settings, PRIME® assesses learner competence through such educational design strategies as performance simulations, practice-feedback sessions involving patient encounters, peer-to-peer virtual town-hall symposia, and technology-driven (eg, Unique Critique®) programs in which expert faculty provide individualized, branching feedback

Figure 2. A model for assessing outcomes of continuing education programs for health professionals. Adapted from Kirkpatrick,5 Miller,6 and Moore et al.7


Grant #8060

to learners in a case-based question-and-answer format.11 PRIME® also applies elements of these strategies to assess outcomes at the level of performance (level 5).

The most pressing challenge for CME/CE providers is to support healthcare professionals in transferring newly acquired knowledge from educational contexts to practice settings, to promote improvement in performance. The extent to which CME/CE influences performance can be evaluated partly through subjective measures, including post-activity surveys. For example, in a questionnaire administered 60-180 days after an educational activity, PRIME® assesses participants as to how frequently they have applied gap-targeted knowledge in their recent practice, as well as what new actions and interventions they are regularly performing in the clinical setting that they were not performing prior to the CME/CE activity. Though subjective measures, these responses assist PRIME® in tracking the participant’s journey toward performance improvement and in identifying potential new barriers that may thwart the journey, lending important information in the gap analysis.

The ideal approaches to assessing performance outcomes demand direct and objective measures. However, CME/CE providers have traditionally faced many logistical barriers, including patient-privacy issues, in efforts to measure the

effects of educational activities on clinical performance. A major initiative, called performance improvement CME (PI-CME), is currently underway to address this problem, engaging maintenance of certification programs.12,13 Through application of this technology, PRIME® is evaluating the extent to which performance can be measured and level 5 learning can be achieved. The ability to track patient health outcomes (level 6) is an intended result of this technology through patient registry data. The success of this technology will hinge on many factors, not the least of which is the significant time commitment required of learners to fully engage in the PI-CME activity. As a result, PRIME® is also establishing business partnerships with physician member societies and government organizations, where outcomes of patient health and community health may be identified and measured.

The ultimate goal of CME/CE is to support healthcare professionals in closing targeted learning gaps to improve patient health (level 6) and community health (level 7). At present, logistical matters usually prohibit objective assessments of outcomes at these highest levels. The potential impact of PI-CME in providing data to assess patient and community health outcomes remains to be determined through future applications and associated educational research.

References1. Mansouri M, Lockyer J. A meta-analysis of continuing medical education effectiveness. J Contin Educ Health Prof. 2007;27:6-15.

2. Mazmanian PE. Reform of continuing medical education in the United States. J Contin Educ Health Prof. 2005;25:132-133.

3. Kaufman DM. Applying education theory in practice. BMJ. 2003;326:213-216.

4. Grant J. Learning needs assessment: assessing the need. BMJ. 2002;324:156-159.

5. Kirkpatrick D. Revisiting Kirkpatrick’s four-level model. Training and Development. 1996;50:54-59.

6. Miller GE. The assessment of clinical skills/competence/performance. Acad Med. 1990;65(9 Suppl):S63-67.

7. Moore DE, Green JS, Gallis HA. Achieving desired results and improved outcomes: integrating planning and assessment throughout learning activities. J Contin Educ Health Prof. 2009;29(1):1–15.

8. Stahl SM, Grady M, Santiago G, et al. Optimizing outcomes in psychopharmacology continuing medical education (CME): measuring learning and attitudes that may predict knowledge translation into clinical practice. Focus. 2006;4(4):487-495.

9. Wakefield J, Herbert CP, Maclure M, et al. Commitment to change statements can predict actual change in practice. J Contin Educ Health Prof. 2003;23:81–93.

10. Delcourt JL. Commitment to change: a strategy for promoting educational effectiveness. J Contin Educ Health Prof. 2000;20:156–163.

11. PRIME® Education Inc. http://www.primeinc.org.

12. American Academy of Family Physicians. Performance Improvement in Practice. http://www.aafp.org/online/en/home/cme/cmea/cmeapplying/perfimprovement.html. Accessed April 5, 2010.

13. Stowell SA, Karcher RB, Carter RD, et al. Outcomes measurement design for a performance improvement initiative in diabetes care. CE Measure. 2009;3:76-83.

Educational Outcomes Report...Grant # 8060 Accredited provider of medical and professional education...

Documents

Transcript of Educational Outcomes Report...Grant # 8060 Accredited provider of medical and professional education...