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Guidance for Migration of FACIT Measures from Paper to Electronic Platforms This guidance provides instruction and information related to the migration of FACIT measures to any electronic clinical outcome assessment (eCOA) platform. This guidance will be subject to continual review and revision as electronic assessment methods evolve. Font/Layout FACIT items are presented on paper using Times New Roman 12-point font. We suggest that electronic administration aim to be as close to this standard as possible. If a 12-point font is not possible given screen size, the largest reasonable size is recommended. Use of bolded or underlined text from the paper version should be replicated in the e-version. For multiple-item layouts, it is recommended to retain as much of the formatting of the horizontal alignment of items and response options (0-4) in the paper version as possible. A vertical presentation of the response options is acceptable for single-item layouts. Title screen/copyright FACIT.org requires that the title of the measure, version number, and copyright information be listed at least once for each administered assessment. At minimum, an introductory screen should be presented prior to the measure or items with this information; where feasible, please ensure the FACIT copyright is listed on each screen. All copyright information can be found in the header and footer of the paper version of each measure. Instructions/placement FACIT paper-and-pencil measures typically contain two sentences of instructions: “Below is a list of statements that other people with your illness have said are important” and “Please select one number per line to indicate your response as it applies to the past 7 days.” Web-based implementation and/or implementation on larger devices with more than one item per screen must model the placement and wording of the instructions as they appear in the paper-and-pencil version to the extent possible. The first screen should have both instruction sentences and subsequent screens should have only the second sentence of instructions. For implementation on handheld devices, FACIT instructions should appear on a screen preceding the items. While our research suggests that the wording of the instructions is acceptable for electronic administration, we have developed alternative wording for electronic administration in which "circle or mark" has been revised to "select" which can be utilized upon request. Further revisions to the instructions to accommodate eCOA vendor device limitations are acceptable; however, FACIT.org assumes no liability for managing eCOA vendor-specific instructions nor for errors in additionally revised instructions or errors in data collection caused by revisions of instructions by eCOA vendors and their subcontractors. Items per screen For handheld devices, we recommend the display of 1 item per screen, including response options (0-4) and descriptors (not at all, a little bit, somewhat, quite a bit, very much). It is permitted to exclude response options provided the descriptors are included if the developer’s format restricts the use of numbers, but diligence must be paid in assuring proper scoring of the measure. The display of multiple items per screen is recommended with larger device screen formats. For web-based implementation and larger devices such as tablets, developers are encouraged to retain as much of the original paper format as possible. For all devices, scroll bars are not allowed. No FACIT item, including translations, should be revised without permission from FACIT.org. Response option format For web-based implementation and/or implementation on larger devices with more than one item per screen, it is encouraged to replicate the format of the paper-and-pencil version as much as possible. As noted previously, for multiple-item formats, a horizontal alignment of items and response options (0-4) is recommended with the descriptors (not at all, a little bit, somewhat, quite a bit, very much) listed above the response options (0-4). For handheld device implementation with item responses placed in a vertical format, it is recommended to display the response options next to each item, from 0 (not at all) to 4 (very much). Under no circumstances may the order of the response options be changed. No FACIT response option, including translations, should be revised without permission from FACIT.org. Subscale headers We recommend including subscale headers when a full scale/subscale is administered, but it is not required, particularly if it inhibits display of the items themselves. No FACIT subscale header, including translations, should be revised without permission from FACIT.org. Q1/GS7/Skip patterns The skip pattern with an introductory question, such as that with item GS7, should remain consistent with the paper-and-pencil version of the measure. If this is not possible due to eCOA vendor platform limitations, revisions of skip patterns are acceptable; however, FACIT.org assumes no liability for errors in additionally revised skip patterns or errors in data collection caused by revisions of skip patterns by eCOA vendors and their subcontractors. Item skipping Users should be allowed to skip items, though not invited to skip items. Users should be able to revisit items or change responses as desired prior to submitting the completed measure. Item codes, found in the shaded box that runs along the left margin of the FACIT paper forms, should ideally be presented with the item. If they are not, a minimum requirement is that they “travel” with their respective item in the software and into the database. This is essential for proper scoring and communication. Translations All FACIT measures are developed with a universal approach: for languages spoken in more than one country, there is one, universal version of a measure’s translation, rather than country-specific versions. Any changes to a translated FACIT item without written permission from FACIT.org is in violation of Intellectual Property protections and it is possible that the data analysis could be adversely affected. Screen Reviews and Certifications FACIT does not require screen review and approval of its measures. No additional certifications for electronic versions are needed. Updated Recommendations on Evidence Needed to Support Measurement Comparability Among Modes of Data Collection for Patient-Reported Outcome Measures: A Good Practices Report of an ISPOR Task Force (O’Donohoe, et. al. DOI:https://doi.org/10.1016/j.jval.2023.01.001 ) Learn about FACTtrans’ expertise with eCOA’s Version 2 | 14 May 2021

FACT-G7 Functional Assessment of Cancer Therapy – General – 7 Item Version Can be used with patients of any tumor type LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The Functional Assessment of Cancer Therapy – General – 7 Item Version (FACT-G7) is a shortened, 7-item version of the FACT-G designed to quickly and effectively capture the most relevant issues to cancer patients in a valid and reliable manner. Development included oncology patients with advanced cancer from 11 disease sites who ranked the symptoms and concerns they viewed as ‘the very most important’ when undergoing cancer treatment and completed the FACT-G. Of the highest priority cancer-related symptoms and concerns endorsed by patients for inclusion in the FACT-G7, fatigue and ability to enjoy life were ranked the most highly. The FACT-G7 can be used to rapidly assess top-rated symptoms and concerns for a broad spectrum of advanced cancers in clinical practice and research, as well as for quality reporting in cancer chemotherapy and radiation. MEASURE NAME: Functional Assessment of Cancer Therapy – General – 7 Item Version (FACT-G7) VERSION: 4 NUMBER OF ITEMS: 7 PATIENT POPULATION: Cancer patients 18 years and older RECALL PERIOD: Past 7 days RESPONSE SCALE: 5 point Likert-type scale DATA COLLECTION: Paper and electronic ADMINISTRATION: Self-administration and interview when applicable SUBSCALE DOMAINS: Physical well-being, Emotional Well-Being, Functional Well-Being TIME FOR COMPLETION: less than 5 minutes SCORING: Manual scoring template, some items are reverse scored. Total scores possible. RELATED MEASURES: FACT-G , FACT-GP , FANLTC DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-G7 can be obtained by registering for permission. Users are not permitted to translate the FACT-G7 without permission from FACIT.org. Permission from FACIT.org to translate the FACT-G7 may also be contingent upon timeline expectations and availability of FACIT staff. Translations must undergo a rigorous methodology under the guidance of FACIT.org which includes multiple translators, QA steps and cognitive interviews with patients. For commercial use, FACITtrans is the approved translation vendor to translate the FACIT measurement system. Please contact us for more information. VIEW AVAILABLE LANGUAGES Language Availability Licensing Licensing Licensing fees are assessed on a per trial/per measure basis for commercial use. There is no fee for use of the English version, but a license should be obtained. Non-commercial use is assessed on a case-by-case basis. Licensing fees are typically not applied to investigator-initiated research, students, or clinical use. To license an available version of this measure for commercial or non-commercial use, please complete our registration form . All of the information provided in the form will be kept strictly confidential. For questions, please contact us . LICENSE THIS MEASURE Selected References Selected References King, M., Agar, M., Currow, D., Hardy, J., Fazekas, B., & McCaffre, N. Assessing quality of life in palliative care settings: head-to-head comparison of four patient-reported outcome measures (EORTC QLQ-C15-PAL, FACT-Pal, FACT-Pal-14, FACT-G7). Supportive Care in Cancer 2020; 28:141–153. doi: 10.1007/s00520-019-04754-9. Yanez B., Pearman T., Lis C.G., Beaumont J.L., Cella D. The FACT-G7: A rapid version of the Functional Assessment of Cancer Therapy – General (FACT-G) for monitoring symptoms and concerns in oncology practice and research. Annals of Oncology 2013; 24: 1073-1078. doi:10.1093/annonc/mds539. Bonomi, A.E., Cella, D.D., Hahn, E.A., Bjordal, K., Sperner, B., Gangeri, L., Bergman, B., Willems, J., Hanquet, P., & Zittoun, R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Quality of Life Research 1996; 5: 309-320. Eremenco, S., Arnold, B., Cella, D. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions 2005; 28(2): 212-232. Pearman,T., Yanez B., Peipert, J., Wortman K., Beaumont J., & Cella D. Ambulatory cancer and US general population reference values and cutoff scores for the Functional Assessment of Cancer Therapy. Cancer 2014: 2902-2909. doi: 10.1002/cncr.28758. Webster, K., Cella, D., & Yost, K. The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: Properties applications, and interpretation. Health and Quality of Life Outcomes 2003; 1(1): 79-85. Yost K.J., Eton D.T. Combining distribution- and anchor-based approaches to determine minimally important differences: The FACIT experience. Evaluation & the Health Professions 2005; 28(2): 172-191. LICENSE THIS MEASURE Related Measures Related Measures FACT-G Functional Assessment of Cancer Therapy - General LEARN MORE FACT-GP Functional Assessment of Cancer Therapy - General Population LEARN MORE FANLTC Functional Assessment of Non-Life Threatening Conditions LEARN MORE

PROMIS Item Bank v1.0 - Dyspnea Severity Patient Reported Outcomes Measurement Information System Item Bank - Dyspnea Severity For patients with dyspnea LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview A bank of dyspnea items. MEASURE NAME: PROMIS Item Bank v1.0 - Dyspnea Severity VERSION: 1 NUMBER OF ITEMS: 33 PATIENT POPULATION: Dyspnea patients 18 years and older RECALL PERIOD: Past 7 days RESPONSE SCALE: 4 point Likert-type scale DATA COLLECTION: Paper and electronic For permission to implement and administer the measure electronically, please visit: https://www.healthmeasures.net/implement-healthmeasures/administration-platforms ADMINISTRATION: Self-administration and interview when applicable SUBSCALE DOMAINS: Severity TIME FOR COMPLETION: 10-15 minutes SCORING: PROMIS Scoring Service: http://www.healthmeasures.net/score-and-interpret/calculate-scores/scoring-instructions RELATED MEASURES: FACIT-Dyspnea , PROMIS SF v1.0 – Dyspnea-Severity 10a , PROMIS SF v1.0 – Dyspnea-Severity 5b DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the PROMIS Item Bank v1.0 - Dyspnea Severity can be obtained by registering for permission. Users are not permitted to translate the PROMIS Item Bank v1.0 - Dyspnea Severity without permission from FACIT.org. Permission from FACIT.org to translate the PROMIS Item Bank v1.0 - Dyspnea Severity may also be contingent upon timeline expectations and availability of FACIT staff. Translations must undergo a rigorous methodology under the guidance of FACIT.org which includes multiple translators, QA steps and cognitive interviews with patients. For commercial use, FACITtrans is the approved translation vendor to translate the FACIT measurement system. Please contact us for more information. VIEW AVAILABLE LANGUAGES Language Availability Licensing Licensing Licensing fees are assessed on a per trial/per measure basis for commercial use. There is no fee for use of the English version, but a license should be obtained. Non-commercial use is assessed on a case-by-case basis. Licensing fees are typically not applied to investigator-initiated research, students, or clinical use. To license an available version of this measure for commercial or non-commercial use, please complete our registration form . All of the information provided in the form will be kept strictly confidential. For questions, please contact us . LICENSE THIS MEASURE Selected References Selected References Choi, S., Victorson, D., Yount, S., Anton, S., & Cella, D. Development of a conceptual framework and calibrated item banks to measure patient reported dyspnea severity and related functional limitations. Value in Health 2011; 14: 291-306. Ruo, B., Choi, S., Baker, D., Grady, K., & Cella,D. Development and validation of a computer adaptive test measuring dyspnea in heart failure. Journal of Cardiac Failure 2010; 16(8): 659-668. doi: 10.1016/j.cardfail.2010.03.002. Victorson, D., Anton, S., Hamilton, A., Yount, S., & Cella, D. A conceptual model of the experience of dyspnea and functional limitations in COPD. Value in Health 2009; 12(6): 1018-1025. Yount, S., Choi, S., Victorson, D., Ruo, B., Ray, D., Cella, D., Anton, S., & Hamilton, A. (2011) Brief, valid measures of dyspnea and related functional limitations in chronic obstructive pulmonary disease (COPD). Value in Health 2011; 14: 307-315. Bonomi, A.E., Cella, D.D., Hahn, E.A., Bjordal, K., Sperner, B., Gangeri, L., Bergman, B., Willems, J., Hanquet, P., & Zittoun, R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Quality of Life Research 1996; 5: 309-320. Eremenco, S., Arnold, B., Cella, D. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions 2005; 28(2): 212-232. Webster K., Cella D., Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: Properties applications, and interpretation. Health and Quality of Life Outcomes 2003; 1(1): 79-85. Yost K.J., Eton D.T. Combining distribution- and anchor-based approaches to determine minimally important differences: The FACIT experience. Evaluation & the Health Professions 2005; 28(2): 172-191. LICENSE THIS MEASURE Related Measures Related Measures FACIT-Dyspnea Functional Assessment of Chronic Illness Therapy - Dyspnea-10 item LEARN MORE PROMIS SF v1.0 – Dyspnea Severity 10a Patient-Reported Outcomes Measurement Information System Short Form - Dyspnea Severity 10a LEARN MORE PROMIS SF v1.0 – Dyspnea Severity 5b Patient-Reported Outcomes Measurement Information System Short Form - Dyspnea Severity 5b LEARN MORE

Over 25 years of improving patient health status measurement. FACIT.org History OVER 25 YEARS OF IMPROVING PATIENT HEALTH STATUS MEASUREMENT 1990’s 1997 Late 90’s Mid-2000’s 2018 2019 2021 2023 2025 TODAY 1980’s FACIT.org is the licensing entity for the well-known FACIT measurement system. Because of its strong development and validation processes plus its exceptional measurement characteristics, the FACIT System is widely used in clinical and academic research, as well as in clinical trials to capture the patient's perspective of their disease, treatment or condition. 1980s 1980’s The Patient's Perspective in Focus Renowned health outcomes researcher David Cella, Ph.D., develops the Functional Assessment of Cancer Therapy (FACT) questionnaire while completing his post-doctoral studies at Memorial Sloan Cancer Center in New York. (Cella et al, 1993) The results of his work formed the cornerstone of the Functional Assessment of Chronic Illness Therapy, a compilation of over 100 distinct self-report questionnaires that assess a wide variety of symptoms, functional abilities, general perceptions of health and well-being, and other aspects of health-related quality of life. Some of these questionnaires are disease-specific (e.g., cancer, multiple sclerosis, HIV disease), some are related to specific treatment-related toxicities (e.g., central or peripheral neurotoxicity, gastrointestinal toxicity), some are symptom focused (e.g., pain, fatigue), others address physical, mental and social function, and still others assess mood and well-being. All were developed and created with direct input from patients and expert clinicians, and tested for comprehension by native speakers of the languages in which each item has been translated. Cella D.F., Tulsky D.S., Gray G., Sarafian B., Lloyd S., Linn E., Bonomi A., Silberman M., Yellen S.B., Winicour P., Brannon J., Eckberg K., Purl S., Blendowski C., Goodman M., Barnicle M., Stewart I., McHale M., Bonomi P., Kaplan E., Taylor S., Thomas C., Harris J. The Functional Assessment of Cancer Therapy (FACT) Scale: Development and validation of the general measure. Journal of Clinical Oncology 1993; 11(3): 570-579. 1990 1997 Late 90s Mid-2000s 2018 2019 2021 2023 2025 Today 1990’s The FACT Goes Global As globalization evolves, the demand for valid, translated versions of the FACT measures rises. The FACT Translation Project begins, and the FACT-G (General), FACT-B (Breast), FACT-Br (Brain), FACT-BMT (Bone Marrow Transplant), FACT-C (Colorectal), FACT-CNS (Central Nervous System), FACT-Cx (Cervical), FACT-E (Esophageal), FACT-H&N (Head & Neck), FACT-L (Lung), FACT-P (Prostate), FACT-O (Ovarian), and FAHI (HIV) become the first measures translated and linguistically validated into 7 languages following a newly-developed FACIT translation methodology ensuring equivalence across translations. Today, over 100 measures are available in over 80 languages. 1997 FACT Becomes FACIT Functional Assessment of Chronic Illness Therapy (FACIT) is adopted as the formal name to reflect the FACT’s growth and evolution into a system that also includes content to measure diseases, treatments and conditions outside oncology. Late 90’s Item Response Theory and FACIT Advanced methods in statistical and psychometric approaches including item response theory (IRT) provide increasingly robust analytic methods permitting analysis on a per-item basis. Use of IRT to examine an item’s measurement characteristics gives investigators a way to lower patient response burden by only administering items most relevant to patients. Mid-2000’s Dr. Cella Launches PROMIS The National Institute of Health supports this science via an initiative known as PROMIS (Patient Reported Outcomes Measurement Information System), in which Dr. Cella is the Principal Investigator of the Statistical Coordinating Center. A second federally-funded item-banking project specific to neurological conditions, Neuro-QOL, follows; Dr. Cella grants permission for FACIT items to be used in both these initiatives so that these FACIT items can be scored on a national metric. Dr. Cella remains a central resource to the PROMIS Health Organization to this day. 2018 FACIT Searchable Item Library In 2018, the FACIT Searchable Item Library is released. Users may now search FACIT’s 700+ items and develop a custom measure targeted to their specific patients using the Build-a-PRO function. 2019 C-Path PRO Consortium Chooses FACIT.org The Critical Path Institute (C-Path) PRO Consortium chooses FACIT.org to manage licensing for patient reported outcome measures. It is our honor to use our knowledge-base and processes to support such a scientific leading organization. 2021 FACIT.org Doubles Staff FACIT.org doubles our staff to meet ongoing increases in licensing demands of not only FACIT- and C-Path measures but also other questionnaires which FACIT.org now manages. More and more clients trust their measures to our group. 2023 FACIT.org Adapts Internal Infrastructure FACIT.org adapts internal infrastructure to more effectively deliver measures and related documentation (i.e. administration, translation certifications and watermarked versions). Clients praise our process as one of the most efficient in our sector. 2025 FACIT Group Expands Licensing Expertise FACIT Group begins licensing coordination of other COA measures on behalf of clients’ trials, expanding our licensing expertise to help clients navigate the vast landscape of COA’s, developers and fees. Today Looking Ahead FACIT continues to evolve with increasing focus on individual, targeted measurement, the use of Clinical Outcomes Assessments (COA’s) in routine clinical practice and development of new items and measures. Meet the Team David Cella, PhD President, Chief Scientific Officer Jason Bredle, MFA Director Shannon Romo Licensing and Financial Administrator MEET THE WHOLE TEAM