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Clinical outcomes assessment (COA) translation, linguistic validation and cross-cultural assessment with over 25 years expertise providing cutting edge services and consultation to health outcomes researchers in the pharmaceutical industry and in federally-funded initiatives. Translation & Linguistic Validation FOR THE LIFE SCIENCE AND HEALTH STATUS RESEARCH COMMUNITIES We are an industry pioneer in clinical outcome assessment (COA) translation, linguistic validation and cross-cultural assessment with over 25 years expertise providing cutting edge services and consultation to health outcomes researchers in the pharmaceutical industry and in federally-funded initiatives. While our work began with the renowned FACIT Measurement System, it has broadened to include a variety of Clinical Outcome Assessments (COAs) providing valuable services over a broad range of disease areas. We offer a wide range of services for your studies: COA Development Consultation: Translatability Assessment In-trial Interviews COA Translation & Linguistic Validation Interview Transcription and Translation Translation of Consent Forms and Protocols eCOA Adaptation and Migration We look forward to serving your study needs. Contact us to get started! Services Quality in and across projects, no rework. LEARN MORE Publications Active contributors in the fields of translation and COAs. LEARN MORE Affiliations Sponsor and contributor for 25+ years, ISOQOL, ISPOR, ATA, and more. LEARN MORE Label Claims Our translations in label claims. LEARN MORE FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

FACIT Group: Patient-centered outcomes services for clinical trials. Capturing, measuring, translating, linguistically validating and interpreting patients’ perspectives of their disease, treatment or condition. The FACIT Searchable Item Library A comprehensive collection of validated quality-of-life items for chronic illness and treatment outcomes for use in customizable forms. EXPLORE THE LIBRARY Welcome to FACIT Welcome to FACIT Together we are pioneers in the field of patient-centered research with 25+ years of cutting-edge science and services. FACITtrans provides clinical outcomes assessment (COA) translatability assessment, questionnaire, consent form and protocol translation, interview transcription and translation, eCOA adaptation and migration, linguistic validation and more. FACIT.org manages the distribution of and information related to more than 100 questionnaires that measure health-related quality of life for people with chronic illnesses. All items in the FACIT Searchable library were created with direct input from patients and expert clinicians, and tested for comprehension by native speakers of the languages into which each item has been translated. A 不 Translation & Linguistic Validation Services FACIT Measurement System FACIT Searchable Library COA Management & Licensing Services NEWS We are pleased to announce the publication of "Use of AI within COA linguistic validation and eCOA migration processes: analysis and good practice recommendations," co-authored by Benjamin Arnold and Emily Parks-Vernizzi along with the ISOQOL AI TCA-SIG, in JPRO Need help? Contact us.

Clinical outcomes assessment (COA) translation, linguistic validation and cross-cultural assessment with over 25 years expertise providing cutting edge services and consultation to health outcomes researchers in the pharmaceutical industry and in federally-funded initiatives. Translation & Linguistic Validation Services PATIENT FOCUSED, QUALITY DRIVEN As pioneers in the field of translation and linguistic validation of health outcome measures, we uphold our reputation for high quality work, attention to detail, and excellent customer service on every project. We offer a wide range of services for your studies: COA Development Consultation: Translatability Assessment In-trial Interviews COA Translation & Linguistic Validation Interview Transcription and Translation Translation of Consent Forms and Protocols eCOA Adaptation and Migration COA Development COA Development Consultation: Translatability Assessment COA measures are most-often developed in English, and certain concepts may not translate easily or prove to have limited or no conceptual equivalence in other cultures. Translatability Assessment refers to the proactive process of identifying such issues as early in the instrument development process as possible. Concept definition, also referred to as concept elaboration, goes hand in hand with this process and serves to define terminology and intended meaning of items providing acceptable translation alternatives, unacceptable translation alternatives, and offering solutions for specific translation issues within linguistic families. Engagement with instrument developers is crucial at these key stages to ensure the intended meaning of each item is conveyed to produce translated items that say what they mean and mean what they say. COA Translation & Linguistic Validation COA Translation & Linguistic Validation Patients live with their disease, treatment or conditions. As such, patients themselves provide the most informative, useful perspective on a questionnaire's (COA’s) content. FACITtrans’ full COA translation methodology specifically requires interviewing patients with the translated questionnaire and asking them questions about the items in order to fully capture the target-language patient’s voice and experience. This process, called “cognitive interviewing”, helps ensure the final translated versions are as conceptually and culturally equivalent as possible. These steps seek to affirm the linguistic validity of the translated measure and ultimately strengthen our clients’ ability to understand the multinational patient perspective and obtain a label claim from internationally-collected clinical trial data. At FACITtrans, we believe capturing the patient voice is imperative. As highlighted on our History page , our team was part of the original publication of these now widely-accepted translation approaches. For over 20 years our mission has been Providing A Voice for Patients Worldwide. We deliver on this promise to patients and our clients every day. Translation of Consent Forms & Protocols Translation of Consent Forms and Protocols As longtime members of an academic research community we are well versed in the administrative and legal requirements of clinical trial research. We offer tailored translation approaches to handle the standardized documentation such as diaries, event logs, or legal/administrative documentation like consent forms or protocols require simpler translation methods but with rigorous quality and semantic monitoring. In-trial Interviews In-trial Interviews High-quality qualitative research depends on experienced interviewers who can engage with participants professionally while maintaining study integrity. Through our In-trial Interviews – Interviewer Services, FACITtrans coordinates trained interviewers to support structured interviews as part of clinical and outcomes research. All interviewers are carefully vetted by FACITtrans for professionalism, ethical awareness, confidentiality and sound judgment. Clients provide study-specific training to ensure alignment with research protocols, while FACITtrans manages scheduling and coordination with participants. Interview recordings are securely transferred to the client’s designated platform, and training for clinical sites can also be supported when needed. Interview Transcription and Translation Interview Transcription and Translation Conducting interviews in other countries, and need transcripts of the interview in English? We have years of experience transcribing interviews and translating the interviews into English for you. Quality checks are scheduled at each step of the process. eCOA Adaptation and Migration eCOA Adaptation and Migration Electronic Clinical Outcome Assessment (eCOA) captures data electronically in clinical trials. COA measures that were developed for pen and paper administration must be adapted for electronic delivery, and often some adjustments to the measure's instructions or layout are needed. FACITtrans’ eCOA expertise includes: Adapted over 90% of FACIT scales into as many as 70 languages Adapted over 15 non-FACIT instruments into as many as 30 languages Currently supporting >15 pharma clients & eCOA vendors FACITtrans eCOA services: Instruction adaptation for clear patient comprehension Adapt language to fit context of device Multilingual migration to XML, JSON and CSV formats Screenshot proofing across variety of electronic platforms We look forward to serving your study needs. Learn more and Contact us to get started! FAQ How do I obtain permission to use one or more of the FACIT scales? Is there a fee for use? Complete the registration form on this website. Make sure it is clear which FACIT measure you intend to use and the language you need. You will then be contacted by a representative from FACIT. For commercial, for-profit use, translations carry a licensing fee of $1,500 per Latin-alphabet language (e.g., Spanish) and $2,000 per non-Latin-alphabet language (e.g., Hindi).Fees are typically waived for investigator-initiated research, student research, and clinical use.Use of English-language versions is generally free, although relevant permission must always be obtained from FACIT.org.Except for the use of English-language versions, users who do not pay a licensing fee must agree not to earn or enable any financial gain through the distribution, re-use, marketing, or transfer of the licensed questionnaire(s)/measurement(s) in any form. Further, the user must agree that the use or implementation of the FACIT system (including any resulting data) will not be used in any commercial activity and will not benefit any party via any financial transaction. Do I need permission to duplicate the form for use in a research project or clinical setting? Yes, because to do otherwise would violate copyright law. However, we encourage its use and routinely grant permission as part of the initial registration. Duplicate copies can be made from an electronic or paper copy as long as the copyright is respected. When do I have to complete the registration? The registration form is our way of tracking all of the various uses of questionnaires and their translations, so is not limited to those using it formally in a clinical trial. It is also your way of getting permission to copy and use the instrument as well as access to the scoring and interpretation materials. We ask that anyone planning on using one or more FACIT questionnaires for any purpose (where information will be collected from a patient or participant population) complete a copy of this form. This information is often useful in guiding development of new measures, languages, user tools, and interpretation guidelines. At times, it also provides us with opportunities to contact users for collaboration in an area of mutual interest. The information gathered is kept confidential to the extent possible, although generic summaries (not identifying user name or title of project) are often generated and may be made available to the public. Frequently Asked Questions Services Quality in and across projects, no rework. LEARN MORE Publications Active contributors in the fields of translation and COAs. LEARN MORE Affiliations Sponsor and contributor for 25+ years, ISOQOL, ISPOR, ATA, and more. LEARN MORE Label Claims Our translations in label claims. LEARN MORE FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

FACT-ICM-17 Functional Assessment of Cancer Therapy – Immune Checkpoint Modulator 17 Item Symptom Index For patients receiving immunotherapy treatment LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The FACT-ICM-17 is a brief, validated measure developed to assess the most common, distressing, and clinically useful symptomatic ICM-related immune-related adverse events. It is appropriate for use in research as well as routine symptom monitoring and management. MEASURE NAME: Functional Assessment of Cancer Therapy – Immune Checkpoint Modulator 17 Item Symptom Index VERSION: 1 NUMBER OF ITEMS: 17 PATIENT POPULATION: Cancer patients 18 years and older receiving immunotherapy treatment 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: ICM TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, total score possible RELATED MEASURES: FACT-ICM , FACT- G, FACT-RNT DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-ICM-17 can be obtained by registering for permission. Users are not permitted to translate the FACT-ICM-17 without permission from FACIT.org. Permission from FACIT.org to translate the FACT-ICM-17 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 Gudenkauf LM, Tometich DB, Hoogland AI, Li XY, Kirtane K, Small BJ, Barata A, Gonzalez BD, Chung CH, Shafique MR, Gray J, Khushalani NI, Postow MA, Cella D, Webster KA, Dicker AP, Jim HSL. Validation of the Functional Assessment of Cancer Therapy – Immune Checkpoint Modulator 17-Item Symptom Index (FACT-ICM-17) to Facilitate Implementation in Research and Clinical Care. Available at SSRN: https://ssrn.com/abstract=5034323 or http://dx.doi.org/10.2139/ssrn.5034323 Hansen AR, Ala-Leppilampi K, McKillop C, Siu LL, Bedard PL, Abdul Razak AR, Spreafico A, Sridhar SS, Leighl N, Butler MO, Hogg D, Sacher A, Oza AM, Al-Agha R, Maurice C, Chan CT, Shapera S, Feld JJ, Nisenbaum R, Webster K, Cella D, Parsons J. Development of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM): A toxicity subscale to measure quality of life in patients with cancer who are treated with ICMs. Cancer. 2020 Apr 1;126(7):1550-1558. doi: 10.1002/cncr.32692. Epub 2020 Jan 8. PMID: 31914209. Webster KA, O’Connor ML, Hansen AR, Kircher S, Jim HSL, Dicker AP, Janda M, Ala-leppilampi K, Bingham CO III, Feliciano J, Henry NL, Steffen McLouth LE, Cella D. Development of a Functional Assessment of Chronic Illness Therapy item library and primary symptom list for the assessment of patient-reported adverse events associated with immune checkpoint modulators. J Cancer Metastasis Treat 2020;6:8. http://dx.doi.org/10.20517/2394-4722.2019.38. 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 FACT-ICM Functional Assessment of Cancer Therapy – Immune Checkpoint Modulator LEARN MORE FACT-G Functional Assessment of Cancer Therapy – General LEARN MORE FACT-RNT Functional Assessment of Cancer Therapy – Radionuclide Therapy LEARN MORE

Download scoring documents for this measure. BACK FACT-ICM-17 Scoring Downloads Download DOC

Our passion for linguistics is what drives us. FACITtrans Publications OUR PASSION FOR LINGUISTICS IS WHAT DRIVES US Below are selected publications and presentations by our staff, detailing the various approaches and challenges to attaining cross-cultural measurement equivalence. PublicationsTop Your search returned 0 results Japanese version of MICRA: introduction of the Shizuoka Cancer Center version Matsubayashi H, Harada R, Ishihara E, Kiyozumi Y, Higashigawa S, Suzuki R, Cella D, Bredle J, Savic L, Cella P Familial Cancer 25, 9 (2026) https://doi.org/10.1007/s10689-025-00524-1 Use of AI within COA linguistic validation and eCOA migration processes: analysis and good practice recommendations McKown, S., Arnold, B., Boucher, F., Correia H., Eremenco S., Geršić T., Johnson M., Koumbarou A., Matias I., Parks-Vernizzi E., Poepsel T., Son J., Strouse E., Terwee C.B., Wade M. Journal of Patient-Reported Outcomes 10, 34 (2026). https://doi.org/10.1186/s41687-026-01012-5 Cross-Cultural Adaptation and Psychometric Assessment of the Persian Version of the FACIT-Pal Quality of Life Instrument: A Study Protocol Mojahedi Mohammadi A., Mirshahi A., Cella P., Mahmoodi‐Bakhtiari B., Bakitas M., Bagcivan G., Sayyar A., Bredle J., Asgari A., Karbasi‐Motlagh M. Health Science Reports , 2026; 9:e72068 https://doi.org/10.1002/hsr2.72068 Ensuring relevance and equity in patient reported outcomes (PROs) in endometrial cancer: The SGO promote study (Patient Reported Outcomes Measurement Opportunities Through Equity) Wenzel L., McKinney C., Jensen S., Peipert D., Ganatra S., Bredle J., Sisodia R., Doll K., Philp L., Arend R., Dholakia J., Cella D. Gynecologic Oncology Volume 194, March 2025, pp. 137-144 https://doi.org/10.1016/j.ygyno.2025.02.020 Principles of good practice for concept definition in the context of translation and linguistic validation of clinical outcome assessments (COAs) Arnold, B., Weiss, D., Parks-Vernizzi, E. et al. J Patient Rep Outcomes 9 , 89 (2025). https://doi.org/10.1186/s41687-025-00920-2 Did The Kids Understand? Translating Key Concepts in Norwegian PROMIS Pediatric and Proxy Measures Boucher A., Parks-Vernizzi E., Cella P., Arnold B., Correia H., Sletten I., Garratt A. Presented at ISOQOL Milwaukee, October 2025. Principles of good practice for translation of electronic clinical outcome assessments Shalhoub, H., Turner, M., Bradley-Gilbride, A., Eremenco, S., Muehlan, H., Parks-Vernizzi, E., Arnold, B., Kulis, D., Anfray, C., Chaplin, J.E., Repo, J.P. J Patient Rep Outcomes 9, 26. https://doi.org/10.1186/s41687-025-00859-4 Translatability Assessment of the Fluid Overload from Nephrotic Syndrome Measure Pérez, B., Carlozzi, N., Arnold, B., Parks-Vernizzi, E., Herzberg, T., Peipert, J.D., Creguer, T., Hurt, C., Lai, J., Raghunathan, T., Ganatra, S., Hashemi, S., Scherr, B., Zhai, Y., Salmon, E. Quality of Life Research (2024) 33:S1–S235 Presented at ISOQOL Cologne, October 2024. Translation and linguistic validation of 24 PROMIS item banks into French Ahmed S, Parks-Vernizzi E, Perez B, Arnold B, Boucher A, Hossenbaccus M, Correia H, Bartlett SJ. Qual Life Res. 2024 Aug;33(8):2119-2127 . doi: 10.1007/s11136-024-03690-4. Epub 2024 Jun 12. PMID: 38865068; PMCID: PMC11286690. Dealing with the Complexities of Concurrently Translating and Implementing Electronic Clinical Outcome Assessments: Best Practices Roundtable: The Two-Step Dance of Concurrent Translation and Implementation of eCOAs Shalhoub, H., Turner, M., Bradley-Gilbride, A., Eremenco, S., Muhlan-Rehmer, H., Parks-Vernizzi, E., Arnold, B., Kulis, D., Anfray, C., Chaplin, J. Quality of Life Research (2024) 33:S1–S235 Presented at ISOQOL Cologne, October 2024. Prev 1 2 3 ... 12 1 ... 1 2 3 4 5 6 7 8 9 10 11 12 ... 12 Next We look forward to serving your study needs. Contact us to get started! FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

Over 25 years of methodologically rigorous COA translations. FACITtrans History OVER 25 YEARS OF METHODOLOGICALLY RIGOROUS COA TRANSLATIONS Today 2024 2023 2022 2021 ISO 2021 2020 ISO 2017 2016 2012 2009 2005 2004 1996 1994 Today 2024 Today Deep Scientific Roots and Cutting Edge Knowledge Quality and processes are our strength. Flexible, creative solutions are our calling card. As lead authors to the ISOQOL AI in COA translation guidance and numerous other publications , we are uniquely placed in the crossroads of technological advances and scientific rigor. While most of our work is for the pharmaceutical industry, we regularly partner with leading academic research groups including the Medical Social Services program at Northwestern University which was founded by our very own Dr. Cella. 2023 2024 Reinforcing Our Global Reach Vendor management expansion to meet demand and reinforce our global reach throughout Africa, India, LATAM, US, and Europe for translation, in-trial interviews and more. 2022 2023 Savic L., Arnold B., Baily A., Mackey DJ., Olaiya P. Translation and Linguistic Validation of the EXACT for Use with COPD Patients in African Countries. Presented at ISOQOL Calgary, October 2023. ISOQOL Poster of the Year In-trial interviews (qualitative, native-language interviews embedded in clinical trials) become a fixed part of our growing service offerings. Not only do we carry out the interviews, but we transcribe and translate them. Clients love our openness to new areas and our constant eye on quality and processes in any area we enter. 2022 In-Trial Research Services 2022 European Team Expansion to Meet Increased Demand 2021 2021 C-Path Selects FACITtrans as Their Preferred Translation Vendor 2021-2023 Thought Leadership in Action Our Executive Director, Emily Parks-Vernizzi, served as ISOQOL’s TCA-SIG Co-Chair and is currently a member of the TCA-SIG Steering Committee and the Digital Health and eCOA SIG ISO 2021 I SO 2021 FACITtrans Earns ISO 17100:2015 Certification Building off our ISO 9001:2015 certification, we placed our translation and processes under additional scrutiny to earn our ISO 17100:2015 certification, further reinforcing our commitment to the patients’ voice through our high-quality COA translation and linguistic validation process. We are proud to receive significant auditor praise for our processes at every surveillance and recertification audit. 2020 2020 JPRO Paper of the Year Our president, Benjamin Arnold, co-authors JPRO paper of the year, “Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures”. FDA cites this article in their guidance to help clinical trial sponsors select, use, and optimize clinical outcome assessments (COAs) in their trials. McKown S, Acquadro C, Anfray C, Arnold B , Eremenco S, Giroudet C, Martin M, Weiss D. Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures. J Patient Rep Outcomes 4 , 89 (2020). https://doi.org/10.1186/s41687-020-00248-z U.S. Food and Drug Administration. Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. FDA-2022-D-1385. U.S. Food and Drug Administration; October 2025. https://www.fda.gov/media/159500/download ISO 2017 I SO 2017 FACITtrans Earns ISO 9001:2015 Certification Quality processes have always been central to our work, which is why our group co-authored the 2005 ISPOR translations guidelines. Our ISO 9001:2015 certification in quality management underscores our commitment to our clients, research collaborators, and patients. 2016 2016-2018 Thought Leadership in Action Our President, Benjamin Arnold, served as ISOQOL’s Translation and Cross-Cultural Adaptation - Special Interest Group (TCA-SIG) Co-Chair, and is currently a member of the TCA-SIG Steering Committee. 2012 2012 eCOA Early Adapters The FACIT measurement system is a forerunner of eCOA adaptation/localization. FACIT Group establishes close ties with leading eCOA developers. 2009 2005 2009 FACITtrans is Born The translation and formatting team formerly part of The Center for Outcomes Research and Education (CORE) becomes FACITtrans, a boutique language service provider under the scientific direction of Dr. Cella, with close connections to the outcomes scientists at Northwestern’s Department of Medical Social Sciences. 2005 Industry Cornerstone Our translation group co-authors the landmark ISPOR translation and cultural adaptation guidelines that are now accepted as industry standard. Wild, D., Grove, A., Martin, M., Eremenco, S., McElroy, S., Verjee-Lorenz, A. and Erikson, P. (2005), Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation. Value in Health, 8: 94-104. https://doi.org/10.1111/j.1524-4733.2005.04054.x 2004 2005 The Translation Group Publishes Universal Translation Article, Causes a Stir The translation group publishes the first-ever article to promote the universal approach to COA translation, which 20 years later is still considered methodologically novel. 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. 2004 Leading the Way with PROMIS FACITtrans develops first-ever PROMIS translations into Spanish and authors the definitive concept definitions for PROMIS. Arnold B., Correia H., Cella D. Translation of the Patient Reported Outcomes Measurement Information System into Spanish. Poster presentation at the 14th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research, Orlando, FL, 2009. 1996 1994 1996 The FACIT Translation Methodology Is Official Bonomi, A.E., Cella, D.F., 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. 1994 Clinicians Request the FACT-G in Spanish Our translation group is born, with equivalence and quality at the forefront of our work. Meet the Team Benjamin Arnold, MA President Emily Parks-Vernizzi, MBA Executive Director MEET THE WHOLE TEAM FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

FACITtrans is much more than a translation company. We are an experienced health outcomes group trained in rigorous scientific principles, grounded in robust quality control systems, ISO 9001:2015 certified, and committed to low administrative burden for our clients and vendors. FACITtrans Expertise ACADEMICALLY TRAINED, SCIENTIFICALLY RIGOROUS FACITtrans is much more than a translation company. We are an experienced health outcomes group trained in rigorous scientific principles, grounded in robust quality control systems, ISO 9001:2015 certified, and committed to low administrative burden for our clients and vendors. Small, but mighty, industry powerhouse We have translated and linguistically validated over 100 FACIT measures into over 80 universal language versions, focusing on a wide range of disease areas such as cancer, HIV/AIDS, multiple sclerosis, and general chronic illness. We have translated hundreds of non-FACIT measures into even more languages than those present in the FACIT Measurement System. Principal translation resource for NIH initiatives In addition to our work with the pharmaceutical industry, we serve as the principal resource for translating the item banks in each of the following National Institutes of Health projects (among others): PROMIS (Patient Reported Outcomes Measurement Information System) (U01 AR 052177) NeuroQOL (HHSN 2652004236) NIH Toolbox (AG-260-06-01) We look forward to serving your study needs. Contact us to get started! In 25+ years of providing PRO translations, we have cognitively debriefed more than 10,000 patients internationally. A voice for patients worldwide, for over 25 years Integrated expertise Our translations are grounded in state-of-the-art outcomes measurement science. Because our roots are deep in COA assessments, the translations thereof are not just a business but part of a contiguous research program, which includes all phases of COA development, assessment, measurement and clinical trial consultation. Services Quality in and across projects, no rework. LEARN MORE Label Claims Our translations in label claims. LEARN MORE Publications Active contributors in the fields of translation and COAs. LEARN MORE Affiliations Sponsor and contributor for 25+ years, ISOQOL, ISPOR, ATA, and more. LEARN MORE FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

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

Committed to rigorous scientific measurement of the patient's perspective. FACIT.org Team COMMITTED TO RIGOROUS SCIENTIFIC MEASUREMENT OF THE PATIENT'S PERSPECTIVE Jason Bredle, MFA Director, FACIT.org BIO Shannon Romo Financial Manager BIO Sharon Debb, M.Ed Licensing Manager BIO Robert Martin, BA Licensing Support Specialist BIO Paul Cella, PhD Licensing Support Specialist BIO David Cella, PhD President, Chief Scientific Officer BIO Benjamin Arnold, MA President, FACITtrans, LLC BIO Lauren Lent, DHA, MS Founder, The FACIT Group BIO Luke Pickard, MBA Director of IT, Data Protection Officer (IT DPO) BIO Our History Over 25 years of improving patient health status measurement. LEARN MORE Our Vision, Mission, and Values At FACIT, our passion is the patient. Our mission is to provide a voice for patients worldwide. LEARN MORE

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PROMIS SF v1.0-Dyspnea-Functional Limitations 10a Patient Reported Outcomes Measurement Information System - Short Form - Dyspnea-Functional Limitations 10a For patients with dyspnea LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The PROMIS SF v1.0 – Dyspnea-Functional Limitations 10a is part II of the FACIT-Dyspnea adopted by the PROMIS Health Organization. MEASURE NAME: Patient Reported Outcomes Measurement Information System - Short Form - Dyspnea-Functional Limitations 10a VERSION: 1 NUMBER OF ITEMS: 10 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: Functional Limitations TIME FOR COMPLETION: Less than 5 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 5a , PROMIS SF v1.0 – Dyspnea-Severity 5b DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the PROMIS-SF-v1.0-Dyspnea-Functional Limitations 10a can be obtained by registering for permission. Users are not permitted to translate the PROMIS-SF-v1.0-Dyspnea-Functional LImitations 10a without permission from FACIT.org. Permission from FACIT.org to translate the PROMIS-SF-v1.0-Dyspnea-Functional Limitations 10a 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 5a Patient-Reported Outcomes Measurement Information System Short Form - Dyspnea Severity 5a LEARN MORE PROMIS SF v1.0 – Dyspnea Severity 5b Patient-Reported Outcomes Measurement Information System Short Form - Dyspnea Severity 5b LEARN MORE