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FACIT Measures & Languages OVER 100 MEASURES IN AS MANY AS 80 LANGUAGES Below is a current list of measures available to license from FACIT.org. Permission for use must be obtained by selecting 'license this measure' on any measure's page. Generally, licensing fees are waived for non-profit organizations and clinical settings. A licensing fee will be assessed if the user or any associate of the user intends to use the FACIT system for any commercial or other financially profitable purpose in the context of the relevant study or data. Clinical Outcome Assessments (COA) Translation Most outcomes measures have been developed and validated in English. In order to ensure that data collected in multinational clinical trials can be pooled for analysis and ultimately submitted for a label claim, translated versions of COA's must be as conceptually and culturally equivalent as possible. To achieve this equivalence, a rigorous translation methodology with attendant focus on quality and cultural appropriateness is imperative. Through our industry-wide recognized translation approach, we deliver on the promise that our translations are linguistically and culturally appropriate for each target population, and that patients across the globe understand translated items as intended by the English source instrument. 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. eCOA Translation, Adaptation, Migration and Screenshot Proofreading" Electronic Clinical Outcome Assessment (eCOA) is a way of capturing data electronically in clinical trials. Many measures were developed for paper administration. When adapted for electronic assessment, often there must be some adjustments to the measure’s instructions or layout. 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 provides these 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 Learn about FACTtrans’ expertise with eCOA’s Interview Transcription & Translation Conducting interviews in other countries, but 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. Translation of Consent forms, Diaries, Event Logs and Protocols" As longtime members of an academic research community (it's where we got our start!) we are well versed in the administrative and legal requirements of clinical trial research. 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. Translatability Assessment and Concept Definition 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.

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.

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DMD Diarrhoea Management Diary For patients with metastatic breast cancer LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview Below are the details for the DMD measure: MEASURE NAME: Diarrhoea Management Diary (DMD) VERSION: 9 NUMBER OF ITEMS: 8 PATIENT POPULATION: Metastatic breast cancer patients 18 and older experiencing diarrhoea RECALL PERIOD: Past 7 days RESPONSE SCALE: 4 point scale DATA COLLECTION: Paper and electronic ADMINISTRATION: Self-administration and interview when applicable SUBSCALE DOMAINS: Not available TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template RELATED MEASURES: FACIT-AD , NVMBQ , FACIT-D DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the DMD can be obtained by registering for permission. Users are not permitted to translate the DMD without permission from FACIT.org. Permission from FACIT.org to translate the DMD 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 Harder H, Shilling VM, May SF, Cella D, Schmid P, Fallowfield LJ. The development and initial evaluation of the Diarrhoea Management Diary (DMD) in patients with metastatic breast cancer. Breast Cancer Res Treat . 2020 Oct;183(3):629-638. doi: 10.1007/s10549-020-05798-w. Epub 2020 Jul 27. PMID: 32720113; PMCID: PMC7497672. Abdullah M, Firmansyah M. Clinical Approach and Management of Chronic Diarrhea. Acta Med Indones 2013; 45:157-65. Atherton P, Halyard M, Sloan J, et al. Assessment of patient-reported measures of bowel function before and after pelvic radiotherapy: an ancillary study of the North Central Cancer Treatment Group study N00CA. Support Care Cancer , 2013; 21:1193-9. Benson A III, Ajani J, Catalano R, et al. Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol 2004; 22:2918–26. Cherny N. Evaluation and management of treatment-related diarrhea in patients with advanced cancer: a review. Pain Symptom Manage 2008; 36:413-23. Clark J, Talcott J. Symptom indexes to assess outcomes of treatment for early prostate cancer. Med Care 2001; 39:1118-30. Davidson-Homewood J, Norman A, Kūlchler T, et al. Development of a disease specific questionnaire to supplement a generic tool for QOL in colorectal cancer. Psycho-Oncol 2003; 12:675-85. Haddock M, Sloan J, Bollinger J, et al. Patient Assessment of Bowel Function During and After Pelvic Radiotherapy: Results of a Prospective Phase III North Central Cancer Treatment Group Clinical Trial. J Clin Oncol 2007;25:1255-9. O'Cathain A, Thomas K. "Any other comments?" Open questions on questionnaires – a bane or a bonus to research? BMC Medical Research Methodology 2004; 4:25. Stein A. Chemotherapy-induced diarrhea: pathophysiology, frequency and guideline-based management. Ther Adv Med Oncol 2010; 2:51-63. Temple L, Bacik J, Savatta S, et al. The Development of a Validated Instrument to Evaluate Bowel Function After Sphincter-Preserving Surgery for Rectal Cancer. Dis Colon Rectum 2005;48:1353-65. Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes 2003; 1:79. Wild D, Grove A, Martin M, et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR task force for translating adaptation. Value Health 2005; 2:94-104. LICENSE THIS MEASURE Related Measures Related Measures FACIT-AD Functional Assessment of Chronic Illness Therapy - Abdominal Discomfort LEARN MORE NVMBQ Nausea and Vomiting Management Barriers Questionnaire LEARN MORE FACIT-D Functional Assessment of Chronic Illness Therapy - Diarrhea LEARN MORE

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 Executive Director, FACITtrans LLC BIO Lauren Lent, DHA, MS Executive Director, FACIT.org 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

FACIT Measures & Searchable Library OVERVIEW The FACIT Measurement System is a collection of over 700 items, 130 pediatric items, and 100 validated measures targeted to the management of chronic illness. "FACIT" (Functional Assessment of Chronic Illness Therapy) was adopted as the formal name of the measurement system in 1997 to portray the expansion of the "FACT" (Functional Assessment of Cancer Therapy) questionnaires into other chronic illnesses and conditions. The measurement system, evolving since 1987, began with the creation of a generic core measure called the Functional Assessment of Cancer Therapy-General (FACT-G) . The FACT-G (in version 4 since 1997) is a 27-item compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is considered appropriate for use with patients with any form of cancer, and has also been used and validated in other chronic illness conditions. Validation of the core measure allowed for the evolution of multiple disease, treatment, condition, and other targeted measures. FACIT scales are constructed to complement the FACT-G, addressing relevant disease-, treatment-, or condition-related issues not already covered in the general questionnaire. Each is intended to be as specific as necessary to capture the clinically-relevant problems associated with a given condition or symptom, yet general enough to allow for comparison across diseases, and extension, as appropriate, to other chronic medical conditions. The FACIT Measurement System now includes over 700 items, some of which have been translated into more than 80 languages. Assessment of any one patient is tailored so that the most-relevant questions are asked and administration time for any one assessment is usually less than 15 minutes. The majority of FACIT items have demonstrated face and content validity and were created with direct input from patients and expert clinicians. More recently, FACIT has expanded its catalog of items to the FACIT Searchable Library , where one can create a custom form using the site’s Build-a-PRO function and include only those FACIT items most relevant to one’s study or purpose. While doing so does not instantly validate the custom composition, it does create an opportunity to select specific items relevant to the research question at hand, using content valid items that have undergone careful translation into other languages. It also allows for the opportunity to pursue validation of the assembled set of questions using standard questionnaire validation practice. The practice of selecting an established, fixed FACIT questionnaire is still recommended for any investigator or clinician wishing to obtain a valid, interpretable score on the endpoints provided by that FACIT questionnaire. FACIT Measures FACIT Searchable Library Administration Scoring eCOA Guidance Interpretation Translation & Linguistic Validation Methodology Label Claims FACIT Utilities

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