LORI MCLEOD, PhD Head, Psychometrics and Executive Director of Patient-Centered Outcomes Assessment Education PhD, Quantitative Psychology, University of North Carolina, Chapel Hill, NC MA, Quantitative Psychology, University of North Carolina, Chapel Hill, NC BS, Statistics, Mathematics Education (graduated summa cum laude), North Carolina State University, Raleigh, NC Summary of Professional Experience Lori McLeod, PhD, is Head of Psychometrics and Executive Director of Patient-Centered Outcomes Assessment at RTI-HS. Dr. McLeod is a psychometrician with more than 20 years of measurement experience, including expertise in instrument development and validation, as well as experience developing appropriate health outcome strategies. In her Psychometrics role, she has conducted many psychometric evaluations of both paper-and-pencil and computer-administered instruments. These investigations have included the assessment of scale reliability, validity, responsiveness, and work to define responder thresholds. In addition, Dr. McLeod has experience conducting and analyzing data from clinical trials and observational studies, including data to document burden of disease and treatment benefit. Dr. McLeod has published numerous related manuscripts in Quality of Life Research, Value in Health, Pharmacoeconomics, Mayo Clinic Proceedings, and Psychometrika, and currently serves as a co-editor for Value in Health. She has experience in a wide variety of therapeutic areas, including chronic pain, dermatology, oncology, psychiatry, respiratory, sleep disorders, urology, gastroenterology, and sexual dysfunction. Dr. McLeod also serves as an adjunct faculty in the Department of Health Policy and Management at the University of North Carolina at Chapel Hill. Employment Chronology 2013 to present Adjunct Associate Professor University of North Carolina Department of Health Policy and Management Chapel Hill, NC 2007 to present Head, Psychometrics and RTI Health Solutions Executive Director of Patient- RTI International Centered Outcomes Assessment 2003 to 2006 Director, Psychometrics RTI Health Solutions RTI International 2001 to 2002 Senior Psychometrician RTI Health Solutions RTI International 2000 to 2001 Research Psychologist/ Statistics Research Division Statistician RTI International Research Triangle Park, NC 1998 to 2000 Research Scientist Law School Admission Council Newtown, PA 1995 to 1998 Harold Gulliksen Psychometric Educational Testing Service Fellow Princeton, NJ RTI-HS McLeod-1 1994 to 1995 Research Assistant University of North Carolina L.L. Thurstone Psychometric Laboratory Chapel Hill, NC 1991 to 1998 Research Assistant Testing and Accountability Section Department of Public Instruction Raleigh, NC 1992 to 1993 High School Mathematics Wake County Schools Teacher Raleigh, NC Honors Brenda H. Loyd Outstanding Dissertation Award, National Council on Measurement in Education, 1999 Harold Gulliksen Psychometric Fellowship, Educational Testing Service, September 1995 to May 1998 Statistics Student of the Year, North Carolina State University, 1992 Professional Associations International Society for Quality of Life Research, co-leader for Psychometrics Special Interest Group, 2011 to 2014 American Orthopaedic Society for Sports Medicine, member of the Outcome Measures Consensus Task Force, 2010 to date Psychometric Society, Office of Treasurer, 2000 to 2007 Drug Information Association International Society for Pharmacoeconomics and Outcomes Research Publications Elewski BE, Fox T, Gnanasakthy A, Mallya UG, McLeod L, Mollon P, et al. Psoriasis patients with Psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75-89 response: results from two phase 3 studies of secukinumab. J Dermatolog Treat. 2017 [in press] Mercieca-Bebber R, Rouette J, Calvert M, King M, McLeod L, Holch P, et al. Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension. Qual Life Res. 2017 Feb 7. [Epub] Gottlieb A, Strober B, Lebwohl M, Kaufmann R, Pariser D, …, McLeod L, et al. Greater efficacy with secukinumab treatment is associated with greater psoriasis symptom relief: results from secukinumab clinical trial data. JPPA. 2017 [in press] Strober B, Gottlieb AB, Sherif B, Mollon P, Gilloteau I, McLeod L, et al. Secukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo- controlled clinical trials comparing secukinumab with etanercept. J Am Acad Dermatol. 2017 Jan 10;pii:S0190-9622(16)31159-8. [Epub ahead of print] Strober B, Sigurgeirsson B, Popp G, Sinclair R, Krell J, …, McLeod LD, et al. Secukinumab improves patient-reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo-controlled clinical trials. Int J Dermatol. 2016 Apr;55(4):401-7. RTI-HS McLeod-2 McLeod LD, Cappelleri JC, Hays RD. Best (but oft-forgotten) practices: expressing and interpreting associations and effect sizes in clinical outcome assessments. Am J Clin Nutr. 2016 Mar;103(3):685- 93. Strober B, Zhao Y, Tran MH, Gnanasakthy A, Nyirady J, …, McLeod LD, et al. Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis. Int J Dermatol. 2016 Mar;55(3):e147-55. Williams V, McLeod L, Nelson L. Advances in the evaluation of longitudinal construct validity of clinical outcome assessments. Ther Innov Regul Sci. 2015 Nov;49(6):805-12. Petrillo J, Cano SJ, McLeod LD, Coon CD. Using classical test theory, item response theory, and Rasch measurement theory to evaluate patient-reported outcome measures: a comparison of worked examples. Value Health. 2015 Jan;18(1):25-34. Deal LS, Sleeper-Triplett J, DiBenedetti DB, Nelson L, McLeod L, Haydysch EE, et al. Development and validation of the ADHD Benefits of Coaching Scale (ABCS). J Atten Disord. 2015 Mar;19(3):191-9 Hartman EE, Pawaskar M, Williams VSL, McLeod L, Dubois D, Benninga MA, et al. Psychometric properties of the PedsQL generic core scales for children with functional constipation in the Netherlands. J Pediatr Gastroenterol Nutr. 2014 Dec;59(6):739-47. Mohr P, Harries M, Grange F, Ehness R, Benajmin L, Siakpere O, …, McLeod L, et al. Treatment patterns and disease burden of stage IIIB/IIIC melanoma in France, Germany and the UK. Ann Oncol. 2014 Oct;25(Suppl 4):iv389. Webb SM, Ware JE, Forsythe A, Yang M, Badia X, Nelson LM, …, McLeod L, et al. Treatment effectiveness of pasireotide on health-related quality of life in patients with Cushing’s disease. Eur J Endocrinol. 2014 Jul;171(1):89-98. McLeod L. Review of the Task Force Report on PRO data collection in clinical trials using mixed modes. Value Health. 2014 Jul;17(5):491-2. Chen WC, McLeod LD, Nelson LM, Williams VS, Fehnel SE. Quantitative challenges facing patient- centered outcomes research. Expert Rev Pharmacoecon Outcomes Res. 2014 Jun;14(3):379-86. Coles T, Coon C, DeMuro C, McLeod L, Gnanasakthy A. Psychometric evaluation of the Sheehan Disability Scale in adult patients with attention-deficit/hyperactivity disorder. Neuropsychiatr Dis Treat. 2014 May 19;10:887-95. Strober B, Zhao Y, Tran MH, Gnanasakthy A, Nelson LM, McLeod LD, et al. Psychometric evaluation of the psoriasis symptom diary using phase 3 trial data. Value Health. 2014 May;17(3):A288. Martin S, Coon C, McLeod L, Chandran A, Arnold L. Evaluation of the fibromyalgia diagnostic screen in clinical practice. J Eval Clin Pract. 2014 Apr;20(2):158-65. Fehnel S, DeMuro C, McLeod L, Coon C, Gnanasakthy A. US FDA patient-reported outcome guidance: great expectations and unintended consequences. Expert Rev Pharmacoecon Outcomes Res. 2013;13(4):441-6. Nelson LM, Forsythe A, McLeod L, Pulgar S, Maldonado M, Coles T, et al. Psychometric evaluation of the Cushing’s Quality-of-Life questionnaire. Patient. 2013;6(2):113-24. Coon CD, McLeod LD. Patient-reported outcomes: current perspectives and future directions. Clin Ther. 2013 Apr;35(4):399-401. Reeve BB, Wyrwich KW, Wu AW, Velikova G, Terwee CB, Snyder CF, …, McLeod LD, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient- centered outcomes and comparative effectiveness research. Qual Life Res. 2013 Oct;22(8):1889-905. RTI-HS McLeod-3 Chandran AB, Coon CD, Martin SA, McLeod LD, Coles TM, Arnold LM. Sphygmomanometry- evoked allodynia in chronic pain patients with and without fibromyalgia. Nurs Res. 2012;61(5):363-8. Coon CD, Bokowy KL, Horblyuk R, Zisman RS, McLeod LD, Brown TM. The development and initial assessment of the Strategy and Leadership Systems Capability Evaluation Survey. Health Care Manag (Frederick). 2012;31(4):332-41. Engelhart L, Nelson L, Lewis S, Mordin M, Demuro-Mercon C, Uddin S, McLeod L, et al. Validation of the Knee Injury and Osteoarthritis Outcome Score subscales for patients with articular cartilage lesions of the knee. Am J Sports Med. 2012;40(10):2264-72. Bell C, McLeod L, Nelson L, Fehnel S, Zografos L, Bowers B. Development and psychometric evaluation of a new patient-reported outcome instrument measuring the functional impact of insomnia. Qual Life Res. 2011;20(9):1457-68. Dalal A, Nelson L, Gilligan T, McLeod L, Lewis S, DeMuro-Mercon C. Evaluating patient-reported outcome measurement comparability between paper and alternate versions using the lung function questionnaire as an example. Value Health. 2011;14(5):712-20. McLeod LD, Coon CD, Martin SA, Fehnel SE, Hays RD. Interpreting patient-reported outcome results: US FDA guidance