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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
Prabashni Reddy, Pharm.D., M.S. Director, Clinical Outcomes Research ABT Associates Consulting/Consumer Group Leader
Shiraz Gupta, Pharm.D., M.P.H. 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 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:
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 Task Force Leader Group Draft Survey Preparation
November 2006 Discussions of Draft Survey with Working Groups
December 2006 Finalization of Survey and Dissemination via Survey Monkey
January 2007 Reminders sent to Survey Respondents and non-Respondents
mid month Survey Closed at end of month
February 2007 Tabulation and Preparation of Results
March 2007 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: 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
Established and ongoing record of independent research accomplishments and expertise in the area of PEOR through
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 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:
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:
Study design Study implementation Data collection Data analysis Research program management Reporting
Fellowship Experience The fellow should develop an understanding of multiple aspects of clinical
outcomes through a combination of didactic and on the job training that includes:
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
Costing 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 The fellow should demonstrate proficiency in multiple aspects of
patient-reported outcomes through a combination of didactic and on the job training that includes:
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:
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
The fellow should attain the following grantsmanship skills during the fellowship through a combination of didactic and on the job training that includes:
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
The fellow should develop oral communication skills as well as written communication skills, for example through:
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
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:
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: 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 In addition, the fellow should perform a preceptor and
program evaluation every six months
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
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
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 Baxter International Alexander Chernavin Sanofi-Aventis Zeba Khan Novartis Pharmaceuticals Connie Mclaughlin-Miley Abbott Laboratories Jenny Sung Novartis Pharmaceuticals Shiraz Gupta TAP Pharmaceuticals Concetta Crivera Ortho-McNeil Neurologics Izhar Hussain Abbott Laboratories Tracy Li Bristol-Myers Squibb Liviu Niculescu Pfizer Vanja Sikirica Ortho-McNeil Janssen
Academia Members
Sandra Kane U. of Pittsburgh John Bridges Johns Hopkins U. Johanita Burger North-West University Jeff Guo U. of Cincinnati Medical Jackie Kwong U. of Georgia Jeffrey McCombs USC College of Pharmacy Lisa Prosser Harvard Med School Vittorio Maio Jefferson Medical College Glen Schumock U of Illinois at Chicago Marianne Mccollum U of Colorado Kim Coley U. of Pittsburgh Craig Currie Cardiff University Scott Strassels U of Texas Austin Dennis Raisch VA Coop Studies Program Gonzalo Garcia-Donato U of Castilla-La Mancha
Consulting and Health Outcomes Customers
Prabashni Reddy ABT Associates Ljubica Besker-Ivasovic Clinica S. Anna Healther Campbell VA Cooperative Alex Fu Cleveland Clinic Emma Guitierrez DeMesa European Commision Lisa Mucha Thomson
Medstat Jens Rathemann PAION Deutschland Anita Varghese CMS/DHHS Krista Yokoyama Wellpoint
Pharmacy Vladimir Zah ZRX Outcomes
Res. Michael Iskedjian PharmIdeas John Doyle 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