Transcript Fellowship Guidelines: Training Requirements

Pharmacoeconomic and
Outcomes Fellowship
Guidelines
ISPOR and ACCP Joint Statement
ISPOR Annual Meeting
May 22, 2007
Task Force Group Leaders
 Alan Bakst,Pharm.D., MBA
Senior Director, Health Economics and Reimbursement
 Baxter International
 Employer Group Leader
 Sandra Kane-Gill, Pharm.D., M.S.
 Asst. Prof., U. of Pittsburgh School of Pharmacy
 Educator Group Leader
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 Prabashni Reddy, Pharm.D., M.S.
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Director, Clinical Outcomes Research
ABT Associates
Consulting/Consumer Group Leader
 Shiraz Gupta, Pharm.D., M.P.H.
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Fellow, HEOR-UIC/TAP Pharmacoeconomic Fellowship
Survey Manager and Analyst
Program Agenda
 Introduction and History of PE Guidelines
 Preparation of Survey and Survey Method
 Training Program Requirements, Qualifications
of Training Site, Fellowship Applicant Criteria
 Fellowship Experience, Evaluation of Fellow,
Preceptor and Program
 Concluding Remarks and open discussion
Why PEOR Fellowship
Guidelines?
 Field of pharmacoeconomics and health
outcomes research is growing rapidly.
 Researchers and consumers of PEOR
data require skills to perform PEOR
research and interpret results for
decision making about adaptation of new
health technologies.
Why PEOR Fellowship
Guidelines?
 Candidates interested in the PEOR field
come from multiple disciplines. Providing
a recommended framework for core
didactic coursework and experiential
training may be valuable for people
seeking entry to the field.
Why PEOR Fellowship
Guidelines?
 Organizations and sponsors interested in
providing training in PEOR can utilize
guidelines to develop their programs
 Professional organizations may utilize
guidelines to accredit PEOR fellowships
 Employers in field can feel comfortable
in the expertise provided by person
completing a fellowship.
Why PEOR Fellowship
Guidelines?
 Assists candidates in evaluating and
comparing training programs
History of PEOR Fellowship
Guidelines
 1999 Am. College of Clinical Pharmacy issues a Position
Statement on Guidelines for PE Research Fellowships
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Pharmacotherapy 1999;19(9):1105-1109
 May 1998 ISPOR position statement on Standards for
fellowship training in pharmacoeconomics and outcomes
research.
 Vittorio Maio, Jennifer Lofland, Tammy Girts, David Nash,
and others who have surveyed PE fellowship programs,
preceptors and fellows, and described their findings in
publications (Am. J. Pharm.Ed. 2003;67 (3) )
Task Force Survey Objectives
 1) Understand how current PEOR researchers and consumers
of health outcomes information valued PEOR fellowship
programs in terms of:
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qualifications of the training site, program, and
preceptor(s),
fellowship applicant requirements,
research commitment,
didactic coursework
evaluation of fellow’s research skills
 2) Develop PEOR fellowship guidelines based on information
attained from the survey.
Survey Development Timeline
 October 2006
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Task Force Leader Group Draft Survey Preparation
 November 2006
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Discussions of Draft Survey with Working Groups
 December 2006
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Finalization of Survey and Dissemination via Survey Monkey
 January 2007
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Reminders sent to Survey Respondents and non-Respondents
mid month
Survey Closed at end of month
 February 2007
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Tabulation and Preparation of Results
 March 2007
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Manuscript Preparation
Survey Design
 Responder Information (organization
membership and practice area)
 6 Sections, 28 questions
 Qualifications of the Training Site
 Qualifications of the Program
 Qualifications of the Preceptor(s)
 Requirements of Fellowship Applicants
 Research Experience Criteria
 Evaluation of Fellows Research Skills
Survey Availability
 Email link to SurveyMonkey.com
 Open from Dec. 31, 2006 – Jan. 31,
2007
 Respondents and non-respondents were
sent 2 reminders:
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Jan. 15, 2007
Jan. 29, 2007
Survey Respondents
 ISPOR Fellowship Task Force
 ACCP Outcomes and Economics
Practice Research Network (PRN)
 280 Total Survey Recipients
 117 Total Survey Respondents
 42% Response Rate
Analysis of Data
 Response frequencies calculated as
percentage of total responses per
question
 Free-text response data incorporated in
discussion sections of guidelines
Training Program Requirements
 A minimum of 3,000 hours
(approximately 75%) of the fellowship
training time should be devoted to
PEOR research-related activities over a
minimum period of two years.
 Develop a documented training plan
with goals and objectives prior to
starting the fellowship.
Training Program Requirements
 Availability of advanced educational
opportunities in research-related topics.
 Ready access to personnel that teach
and use research skills.
 Have a team of preceptors however
fellow assigned one preceptor to be an
advisor to oversee the fellow’s training
and fellowship experience.
Qualifications of Site
 Demonstrate capabilities in performing
PEOR through publications,
presentation at scientific meetings or
through known collaboration with
organizations producing PEOR.
 Direct or indirect access to healthcare
information providing fellow with data to
perform PEOR.
 Appropriate facilities to conduct
research
Qualifications of Site
 Administrative support for the
preceptor’s research program and the
fellowship training program.
 Ready access to a medical library or
electronic access to medical literature
as well as computing facilities.
 Access to other sites to provide fellow
with experience in multiple practice
environments
Preceptor Qualifications
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Established and ongoing record of
independent research accomplishments and
expertise in the area of PEOR through
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Fellowship training, a graduate degree and/or
equivalent experience
Principal or primary investigator on research
grants and/or projects
Published research papers in the peer-reviewed
scientific literature on which the preceptor is the
primary or senior author
Preceptor Qualifications
 Didactic training in research methods
and PEOR.
 Prior experience training fellows and/or
other individuals in PEOR.
 Active collaborative research
relationship with other health outcomes
researchers or organizations.
Fellowship Experience
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The fellow should demonstrate proficiency in multiple aspects of a
PEOR fellowship through participation in one or multiple studies
during their training. These may include:
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Literature reviews
Dossier development
Prospective studies
Retrospective studies
Economic modeling
Patient reported outcomes
The fellow should actively participate in all aspects of research
through a combination of didactic and on the job training including:
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Study design
Study implementation
Data collection
Data analysis
Research program management
Reporting
Fellowship Experience
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The fellow should develop an understanding of multiple aspects of
clinical outcomes through a combination of didactic and on the job
training that includes:
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Clinical markers (e.g., BP, LDL, glucose) of disease
Impact of disease on patients
Impact of drug on patients
Patient safety (e.g., adverse events)
Adherence/Compliance/Persistence
Process and delivery of care
The fellow should demonstrate proficiency in multiple aspects of
economic outcomes through a combination of didactic and on the
job training that includes
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Costing
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Direct medical costs e.g., drug, office visit, hospitalizations, etc.
Direct non-medical costs e.g., caregiver costs
Indirect costs e.g., loss of work, productivity outcomes (e.g., absenteeism,
presenteeism)
Economic analyses e.g., cost-benefit, cost-effectiveness, cost-minimization,
or cost-utility
Fellowship Experience
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The fellow should demonstrate proficiency in multiple aspects of
patient-reported outcomes through a combination of didactic and
on the job training that includes:
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Health-related quality of life
Patient satisfaction
Patient preference
The fellow should develop an understanding of multiple aspects of
the healthcare delivery system and the implications on PEOR within
these systems through a combination of didactic and on the job
training that includes:
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Healthcare financing
Payors/managed care and integrated delivery systems
Health technology assessment
Clinical practice guideline development and use,
Disease management,
Medication use policy analysis
Fellowship Experience
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The fellow should attain the following grantsmanship skills during
the fellowship through a combination of didactic and on the job
training that includes:
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The fellow should develop oral communication skills as well as
written communication skills, for example through:
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Identification of sources of funding,
Grant and/or proposal development
Conception of research ideas
Literature retrieval and evaluation
Biomedical science ethics
Identification of issues related to quality/integrity of HEOR data
Participation in professional and or public communication of PEOR
Preparation of reports, abstracts, and manuscripts
The fellow should be encouraged to participate in journal clubs,
research workshops and/or seminar series
Evaluation of Fellow, Preceptor
and Program
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An evaluation of the fellow should ideally occur at 6-month intervals
The fellow should be evaluated based on the goals and objectives set at
the beginning of the fellowship.
Objective criteria include:
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Poster and/or oral presentation at a national meeting
Seminar on PEOR related topic
Manuscript submission/publication
Research project executed in full
Subjective criteria include:
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Motivation
Professionalism
Communication skills (verbal, e-mail, formal writing)
Presentation skills (research ideas and findings)
Collaboration/team work skills
Ability to evaluate clinical, economic, and PRO literature
Research skills (question development, process, management, analysis, etc)
Time management
Evaluation of Fellow, Preceptor
and Program
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In addition, the fellow should perform a preceptor and
program evaluation every six months
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The fellow should use the goals and learning objectives
developed at the beginning of the fellowship to determine if
the program is progressing as planned
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This is an optimal time to discuss modification of the goals
and objectives incase the fellow has developed additional
interests or altered their original interests
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It is recommended that the fellow be able to express their
assessment of the primary preceptor and contributing
preceptors’ abilities to support/accomplish the outlined goals
and objectives
Employer Working Group
Members
 Alan Bakst
 Alexander Chernavin
 Zeba Khan
 Connie Mclaughlin-Miley
 Jenny Sung
 Shiraz Gupta
 Concetta Crivera
 Izhar Hussain
 Tracy Li
 Liviu Niculescu
 Vanja Sikirica
Baxter International
Sanofi-Aventis
Novartis Pharmaceuticals
Abbott Laboratories
Novartis Pharmaceuticals
TAP Pharmaceuticals
Ortho-McNeil Neurologics
Abbott Laboratories
Bristol-Myers Squibb
Pfizer
Ortho-McNeil Janssen
Academia Members
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Sandra Kane
John Bridges
Johanita Burger
Jeff Guo
Jackie Kwong
Jeffrey McCombs
Lisa Prosser
Vittorio Maio
Glen Schumock
Marianne Mccollum
Kim Coley
Craig Currie
Scott Strassels
Dennis Raisch
Gonzalo Garcia-Donato
U. of Pittsburgh
Johns Hopkins U.
North-West University
U. of Cincinnati Medical
U. of Georgia
USC College of Pharmacy
Harvard Med School
Jefferson Medical College
U of Illinois at Chicago
U of Colorado
U. of Pittsburgh
Cardiff University
U of Texas Austin
VA Coop Studies Program
U of Castilla-La Mancha
Consulting and Health Outcomes Customers
 Prabashni Reddy
 Ljubica Besker-Ivasovic
 Healther Campbell
 Alex Fu
 Emma Guitierrez DeMesa
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Commision
Lisa Mucha
Jens Rathemann
Anita Varghese
Krista Yokoyama
Vladimir Zah
Michael Iskedjian
John Doyle
ABT Associates
Clinica S. Anna
VA Cooperative
Cleveland Clinic
European
Thomson Medstat
PAION Deutschland
CMS/DHHS
Wellpoint Pharmacy
ZRX Outcomes Res.
PharmIdeas
Analytica Int.
Next Steps
 Draft PEOR Fellowship Guidelines to be
placed on ISPOR website for comments
 PEOR Guidelines to be published in
Pharmacotherapy and on ISPOR and
ACCP Websites