Class Meeting Times and Class Location: Monday pm Room Mellon 432

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1 Course Title: Patient-Reported Health Outcomes Academic Semester: Course Number: GPSC 591 Academic Credit (hours): 3 Prerequisites: --- Category: Elective Class Meeting Times and Class Location: Monday pm Room Mellon 432 Course Instructor: Khalid M. Kamal, M.Pharm., Ph.D. Associate Professor Division of Pharmaceutical, Administrative and Social Sciences Office: 418B Mellon Hall Phone: Fax: kamalk@duq.edu Office Hours: By Appointment Course Description Patient-Reported Outcomes (PROs) studies evaluate the impact of disease, medical care and treatment from the patient's perspective. The goal of this course is to provide the student with an overview of health outcomes research. The course will focus heavily on PROs such as quality of life, self-reported health status, patient satisfaction, health state preferences, and adherence to therapy. Principles of measurement, reliability, validity, responsiveness, analysis and interpretation will be discussed using examples drawn from specific quality-of-life instruments and their applications. The student will gain an appreciation of the measurement and evaluation of PROs and its importance in new drug applications as well as in drug labeling and advertising. Goals Upon completion of this course, the enrollee will be better able to: Identify learning goals of health outcomes research and patient-reported outcomes (PROs). Discuss the rationale for including PRO measures in pharmaceutical studies. Discuss the criteria for selecting a PRO measure. Discuss the different approaches to and challenges of assessing PROs. Identify the strengths and limitations of each approach. Evaluate and select PRO measures, including generic, multidimensional, condition-specific, and satisfaction. 1

2 Develop a fundamental understanding of the issues surrounding the development of a PRO measure including item selection, scale development, and measurement of scales. Identify major types of reliability and validity used to evaluate PRO measures. Discuss issues and concepts related to decision theory and preference-based assessment. Discuss the concepts and measurement issues related to adherence to therapy. Evaluate and discuss the general strengths and weaknesses of outcome measures encountered in the literature. Describe how PROs are used by pharmaceutical companies, FDA, clinicians, and other healthcare decision makers. Textbooks and/or other Course Materials Recommended Text Fayers PM and Machin D. Quality of Life - Assessment, Analysis and Interpretation. John Wiley & Sons, Ltd, Educational Technology Requirements The course syllabus and course documents such as PowerPoint slides will be posted on the course Blackboard site. Additional readings will be provided by the instructor. Assignment Description: 125 points Concept paper 5 points Following the third class session, each student will identify a disease-specific PRO measure that will become the focus of three assignments. A two-page paper should briefly describe the health problem of interest (e.g., diabetes, depression, arthritis). If necessary, you may change topics after this concept paper has been submitted. The purpose is to get you started on a project early in the semester. Due: Week 4 Background information & literature review 50 points The student will perform a literature search to identify the measures frequently used to assess PROs within the context of the chosen health problem. Based on the literature review, the student should select the most widely used PRO measure and provide a description of the measure as well as report on its reliability, validity, and responsiveness. The student will also submit a review of all the studies that have used the selected PRO measure. Due: Week 8 Structure: Introduction, Objectives, Methods (search strategy, inclusion/exclusion criteria, PRISMA Flow Diagram Results, Discussions Sample Paper: Chopra I, Kamal KM. A systematic review of quality of life instruments in longterm breast cancer survivors. Health and Quality of Life Outcomes 2012, 10:14 (31 January 2012) Applications (Class presentation) 50 points Critical evaluation of one study that has used the selected PRO measure in areas such as evaluating the impact of illness, evaluating the impact of pharmacotherapy (clinical trials or observation studies) or evaluating individual patients in clinical settings. The presentation should address appropriateness of the measure, performance of the measure, and interpretation of study findings. Students will be allocated minutes to present their critiques and minutes for 2

3 class discussion. Presentation will be evaluated by instructor and peers. Due: Presentation Nov 14, 2016; Final Paper - Week 12 Critical Reviews of Journal Article 20 points Students must critique two published journal articles based on the criteria discussed in class in 300 words. Class Participation: 10 points Excellent Shows understanding of the readings and applies concepts from readings and lectures to course activities; provides effective feedback to peers work. 10 points. Fair Participates thoughtfully but shows little evidence of understanding the concepts from readings and lectures during course activities. 5 points. Poor Attends but does not contribute ideas; gives no constructive/relevant feedback to peers. 1-2 points. In-Class Exercises: 15 points Total: 150 Points Grading Policy The following grading scheme will be used: A = C+ = A- = C = B+ = D = B = F = < 60 B- = I Failure to complete all assignments in a manner justifying the student s readiness to begin thesis-level work. Class Attendance and Participation Attendance is highly encouraged for this course and will contribute to your participation score. Participation includes contributing to class discussion and having prepared yourself to do so. Class participation is a significant portion of the course grade. Please notify the professor prior to class time in the event of an emergency that would prevent you from attending class. If a student is absent from class due to an extenuating circumstance he/she will have the opportunity to do a brief written assignment as a make-up for participation. In-class Behavior Students in the graduate program are expected to exhibit professional behavior at all times and the instructor endeavors to foster an environment of mutual respect and professionalism in the classroom. Disruptive behavior (loud or continuous talking, text messaging, use of cell phones, or other disruptive behaviors) will not be tolerated during class. Students are expected to be active in discussions while respecting the opinions of fellow classmates. Educational Technology Requirements Blackboard will be utilized to communicate course materials as needed. 3

4 Course Domains, Competencies and Learning Outcomes In accordance with the Graduate School of Pharmaceutical Sciences List of Domains, Competencies, and Learning Outcomes, the following outcomes are addressed throughout the course (and can be referenced via Blackboard): Domain A (Conceptual): A.1.2 Domain B (Technical): B.1.1, B.2.1, B.3 Domain C (Integrative): C.1, C.2., C.3 Domain D (Professional): D.1.3, D.2, D.3.1-3, D.4 Project Rubric Category Unacceptable Marginal Proficient Exemplary Score Background and Literature Review (50 POINTS) Project Writing (5 points) - Spelling, Grammar, Punctuation, Sentence Structure - Level of Writing and Organization Introduction (10 points) Literature Review (15 points) Results and Discussions (20 points) Writing contains multiple noticeable errors (0 point) Writing is on a very elementary level; Concepts and ideas are confusing; paper not organized (0 point) No description of the health issue or instruments ( 0 point) No review or literature, guidelines, etc. conducted; No references cited (0 point) Paper covers little of the topic in a superficial manner. Ideas flow poorly AND examples are insufficient. (< 5 points) Writing contains several errors (0 point) Writing is on an beginning level; some concepts and ideas are not well-explained; paper poorly organized (1 points) Brief description of the health issue; instruments are briefly discussed (3 points) Minimal-depth review of literature, guidelines, etc. conducted; 1 to 3 quality references cited, inclusion/ exclusion or search strategy not described (5 points) Paper covers only part of the topic with weak depth & scope. Ideas flow poorly OR examples are insufficient. (10 points) Writing contains few errors (1 points) Writing is on an average level; a few concepts and ideas are not well-explained; good organization (2 points) Adequate description of the health issue; instruments are adequately described (6 points) Average-depth review of literature, guidelines, etc. conducted; inclusion/exclusion or search strategy adequately described, quality references cited using AMA citation style (10 points) Paper covers most of the topic with average depth & scope. Ideas flow adequately; some examples given. (15 points) Writing is free from errors (2 points) Writing is excellent and engaging; All concepts and ideas are clear to the reader; Excellent organization (3points) The health issue described thoroughly; instruments are discussed well (10 points) Extensive review of literature conducted; inclusion/exclusion, search strategy, PRISMA described in-depth, quality references cited using AMA citation style (15 points) Paper covers the entire topic, creatively with excellent depth & scope. Ideas flow clearly and essay uses many strong examples. (20 points) 4

5 Policy for late/missed assignments No credit will be given for late or missed assignments; please refer to due dates described in this syllabus and discussed with course faculty. The only exception to this rule will be for excused absences which may be obtained with authorization from the course coordinator prior to the missed session in question, or through Student Services for other circumstances (illness, emergency, etc.). Administrative policies governing all courses Students are required to review these policies in their entirety. Complete copies of or links to the policies may be found on the Blackboard site: Late/missed exams policy Grade appeal policy Policy on services for students with disabilities Audio/visual recording policy Services for students with disabilities The Graduate School of Pharmaceutical Sciences has a long-standing commitment and adherence to academic integrity as a critical component of professional conduct. Pharmacy students are bound by the Duquesne University Academic Integrity Policy and the Mylan School of Pharmacy Code of Student Conduct. The Code of Student Rights, Responsibilities and Conduct Duquesne University Academic Integrity Policy and Procedures School of Pharmacy: Professional and Graduate Students Graduate Students Academic Policies and Procedures Academic Integrity 5

6 Course Outline Aug 29 Week 1 Introduction to Health Outcomes Research and Patient-Reported Outcomes Doward L, McKenna SP. Defining Patient-reported outcomes. Value in Health 2004;7(suppl.1):S4-S8. Donaldson M. Using patient-reported outcomes in clinical oncology practice: benefits, challenges and next steps. Expert Rev. Pharmacoeconomics Outcomes Res. 2006;6(1): Sept 5 NO CLASS Sept 12 Week 2 Health-Related Quality of Life Concept and Measures Dedhiya S, Kong XS. Quality of life: An overview of the concept and measures. Pharmacy World and Science 1995;17(5): Anderson KL, Burckhardt CS. Conceptualization and measurement of quality of life as an outcome variable for health care intervention and research. J Adv Nursing 1999; 29(2): MacKeigan LD, Pathak DS. Overview of health-related quality-of-life measures. Am J Hosp Pharm 1992;49: Sept 19 Week 3 Health-Related Quality of Life Measurement Issues Devising items, scaling responses, selecting items McKenna SP et al. Development of needs-based quality of life instruments. Value in Health 2004; 7(suppl. 1):S17-S21. Juniper EF et al. Clinical impact versus factor analysis for quality of life questionnaire. J Clin Epidemiology 1997; 50(3): Gustaaf SP, Trumble-Waddell J. A New perspective on quality of life. J Clin Epidemiology 1997; 50(3): Tennant A. Application of Rasch analysis in the development and application of quality of life instruments. Value in Health 2004; 7(suppl. 1):S22-S26. Sept 26 Week 4 Health-Related Quality of Life Validation Strategies Reliability, validity, sensitivity and responsiveness Doward LC, Meads DM, Thorsen H. Requirements for quality of life instruments in clinical research. Value in Health 2004; 7(suppl. 1):S13-S16. McHorney et al. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 1993; 31(3): Fowler FJ et al. Methodological issues in measuring Patient-Reported Outcomes: the agenda of the work group on outcome assessment. Med Care 1994;32(7):JS65-JS76. 6

7 Oct 3 Week 5 Health State Preferences/Utilities Concept, Measurement, and Challenges Torrance GW. Utility approach to measuring health-related quality of life. J Chron Dis. 1987;40(6): Kattan MW. Comparing treatment outcomes using utility assessment for healthrelated quality of life. Oncology 2003;17(12): Bennett K, Torrance G, Tugwell P. Methodologic challenges in the development of utility measures of health-related quality of life in rheumatoid arthritis. Controlled Clinical Trials 1991;12:118S-128S. Oct 10 Week 6 Health State Preferences/Utilities Decision Theory and Preference-based Assessment (VAS, Standard gamble, Time trade-off, HUI, EQ-5D, SF-36) Neumann PJ, Goldie SJ, Weinstein MC. Preference-based measures in economic evaluation in health care. Annu Rev Public Health 2000;21: Cranney A et al. The psychometric properties of patient preferences in osteoporosis. J Rheumatol. 2001;28(1): Oct 17 Week 7 Patient Satisfaction Concept and Measurement Shikiar R, Rentz AM. Satisfaction with medication: An overview of conceptual, methodologic, and regulatory issues. Value in Health 2004; 7(2): Sitzia J, Wood N. Patient satisfaction: A review of issues and concepts. Soc Sci Med 1997; 45(12): Larson LN, Rovers JP, MacKeigan LD. Patient satisfaction with pharmaceutical care: Update of a validated instrument. JAPhA 2002;42(1): Copy of Patient Satisfaction Questionnaire. Oct 24 Week 8 Adherence to Therapy PHYSICIAN INTERVIEW Concept and Measurement using Primary as well as Secondary Data MacLaughlin EJ et al. Assessing medication adherence in the elderly. Drugs Aging 2005;22(3): Garber MC et al. Concordance of self-report with other measures of medication adherence. Med Care 2004;42(7): Steiner JF, Prochazka AV. The assessment of refill compliance using pharmacy records: Methods, validity, and applications. J Clin Epidemiology 1997;50(1):

8 Oct 31 Week 9 Patient-Reported Outcomes and Clinical Trials Pharmaceutical industry, FDA, clinicians, and other healthcare decision makers Wiklund I. Assessment of patient-reported outcomes in clinical trials: the example of healthrelated quality of life. Fundamental and Clin Pharmacol. 2004;18: Dennison CR. The role of patient-reported outcomes in evaluating the quality of oncology care. Am J Manag Care 2002;8:S580-S586. FDA working paper Nov 7 Guest Lectures Physician and Industry Perspectives Week 10 Nov 14 Patient-Reported Outcomes Student presentations Week 11 Nov 21 NO CLASS (THANKSGIVING BREAK) Nov. 28 FINAL PROJECT DUE Week 12 8