1. Final item banks will be calibrated in a sample of 200 patients (100 CAM and 100 GIM) in clinical settings and 1,300 members of the general population via an Internet survey panel. Item Response Theory (IRT) calibration will allow us to create instruments that provide maximum information with as few as 4 items per domain when administered via Computer Adaptive Testing or approximately 8 items on hard-copy short forms. Development of Items for the Patient-Reported Healing Context in CAM Colditz J 1, Greco C 2, Dodds N 1, Giang R 1, Glick R 2, Johnston K 1, Klem M 3, Maihoefer C 1, Morone N 4, Schneider M 5, Pilkonis P 2 University of Pittsburgh: 1 Western Psychiatric Institute and Clinic (UPMC), 2 Department of Psychiatry, 3 Health Sciences Library System, 4 Department of Medicine, 5 School of Health and Rehabilitation Sciences Focus Groups: 2 CAM (n = 8 & 9), 2 General Internal Medicine (GIM; n = 6 & 7), 2 Community (n = 8 & 8), N = 46, Age M = 40 (SD = 14, Range: 20 – 75), 28% Male, 41% Minority, Reading level M = 11 th grade (SD = 2, Range: 3 rd grade – post-high school) Literature Searches: 650 Search Terms 8 Library Databases 17,515 Citation Records Content Experts: Interviews with more than two dozen researchers and clinicians in the field, including an internationally renowned expert on healing environment. Domain Conceptualization: Broad domains and hierarchical sub-domains provide keywords for literature searches and a categorical framework for “binning” items Item Retrieval: 10 Reviewers code abstracts for retrieval of instruments 14,864 Unique Abstracts 535 Instruments Obtained >16,000 Items to Database Binning and Winnowing: Researchers and clinicians work across multiple teams (3-6 reviewers each) to bin items into domain frameworks, reduce redundancy, and revise for consistency 359 Items Retained and Revised: 49 Treatment Expectancy 63 Positive Appraisal 44 Locus of Control 43 Spirituality 39 Attitudes Towards Medicine 72 Patient-Provider Encounter 49 Healthcare Environment Cognitive Interviews and Rewriting: N = 42 ( 1 / 3 CAM, 1 / 3 GIM, 1 / 3 Community), Age M = 47 (SD = 16, Range: 19 – 84), 40% Male, 33% Minority, Reading level M = 12 th grade (SD = 2, Range: 6 th grade – post-high school) Each item reviewed by 6 participants, two from each of the three study groups, stratified by age, race, gender, and education level Interviewers and researchers meet to rewrite items for clarity, per interview feedback Literacy Demand Analysis: Reading demand M = 4th grade (SD = 3) Min < 1 st grade (e.g., “I like to be in charge of things.”) Max > 12 th grade (e.g., “Conventional medicine is dangerous.“) Intellectual Property Review: Comparing items to extant instruments to ensure that calibrated item banks are freely available to the public for research and clinical use Item Banks for Calibration Testing PI: Carol M. Greco, PhD | R01-AT006453 We would like to acknowledge the experts and research participants who provided their valuable insights, allowing us to develop these item banks with the confidence that we have considered a comprehensive range of perspectives on the healing process. Special thanks to Chelsea Smith, Charlotte Tritto, Danielle Pratt, Diana Pak, and Jaskiran Kaur, for their untiring efforts in article retrieval and data entry of the many records and items. More information on PROMIS ® can be found at www.NIHPROMIS.org Throughout this process we incorporate expert insights with patient and community member feedback. The seven resulting domains reflect areas that may prove useful for assessing moderators of health outcomes and placebo effects. This project is the most ambitious effort to-date of reviewing and cataloging the many instruments on these themes, to create a set of versatile and powerful assessments for use in computerized or hard-copy formats. The end result will be a battery of measures that are free to use, easy to integrate into clinical and research environments, and brief enough for patients and research participants to complete in just a few minutes. This process has informed the development of seven conceptual areas and corresponding item pools: Each item is standardized with one of these two response sets: Treatment Expectancy includes projected (future- tense) beliefs about the value and outcomes of a current treatment. Positive Appraisal includes items about current (present-tense) outlook on life and feelings of optimism and hopefulness. Locus of Control includes current feelings of self-efficacy and beliefs about internal vs. external control of one’s life. Spirituality includes current beliefs about a higher power, sense of spiritual connectedness, and spiritual/religious practice. Attitudes Towards Medicine includes current orientations towards CAM vs. conventional medicine, and feelings about science-based and holistic care. Patient-Provider Encounter includes current feelings about a particular healthcare provider, e.g., caring, connectedness, and openness to patient input. Healthcare Environment includes recalled (past- tense) evaluations of a particular setting, e.g., comfort of the waiting area or exam room. The goal of this project is to develop a battery of self-report item banks to measure contextual factors of healing that are generalizable across a broad array of populations and treatment modalities, including Complementary and Alternative Medicine (CAM). Valid tools assessing patient dispositions, patient- provider relations, and perceptions of the healing environment have the potential to identify moderators of treatment outcomes and allow researchers to better understand and dismantle placebo effects. This will be of great benefit to future clinical trials of CAM and conventional medical treatments. This project utilizes the methods established by the NIH Roadmap initiative, Patient-Reported Outcomes Measurement Information System (PROMIS ® ). The initial stages of this process utilize qualitative strategies that establish content validity in domains and individual items, allowing for conceptually meaningful measures to be created. We will then calibrate item banks utilizing an Item Response Theory framework to maximize instrument sensitivity while minimizing respondent burden. The resulting measures will be ideal for Computer Adaptive Testing environments as well as traditional pen-and-paper short forms. Significance Methods Next Steps Conclusions Results Never Rarely Sometimes Often Almost always Not at all A little bit Somewhat Quite a bit Very much