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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 Introducing the FACT-ICM-17 , a brief, validated measure developed to assess the most common, distressing, and clinically useful symptomatic ICM-related immune-related adverse events Need help? Contact us.

See the most current list of measures available to license from FACIT.org. Permission for use can be obtained by selecting 'license this measure' on any measure's page. 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.

View all available languages for this measure. BACK FEnSI Languages English German Spanish Turkish

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FEnSI Functional Assessment of Cancer Therapy – Endometrial Symptom Index For patients with Endometrial cancer LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The FEnSI is a clinically meaningful patient-reported symptom index reflecting the symptoms and concerns identified as most important by diverse patients with endometrial cancer. MEASURE NAME: Functional Assessment of Cancer Therapy – Endometrial Symptom Index (FEnSI) VERSION: 2 NUMBER OF ITEMS: 23 PATIENT POPULATION: Endometrial 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, Emotional, Treatment Side-Effects, Function and Well-Being TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores possible. RELATED MEASURES: FACT-En , FACT-Cx , FACT-O DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FEnSI can be obtained by registering for permission. Users are not permitted to translate the FEnSI without permission from FACIT.org. Permission from FACIT.org to translate the FEnSI 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 Wenzel L., McKinney C., Jensen S., Peipert D., Ganatra S., Bredle J., Sisodia R., Doll K., Philp L., Arend R., Dholakia J., Cella D. Ensuring relevance and equity in patient reported outcomes (PROs) in endometrial cancer: The SGO promote study (Patient Reported Outcomes Measurement Opportunities Through Equity).Gynecologic Oncology Volume 194, March 2025, pp. 137-144 https://doi.org/10.1016/j.ygyno.2025.02.020 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-En Functional Assessment of Cancer Therapy – Endometrial LEARN MORE FACT-Cx Functional Assessment of Cancer Therapy – Cervix LEARN MORE FACT-O Functional Assessment of Cancer Therapy – Ovarian LEARN MORE

View all available languages for this measure. BACK FACT-G Caregiver Languages Danish English German Italian

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 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 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. Translation and Linguistic Validation of the EXACT for Use with COPD Patients in African Countries Savic L., Arnold B., Baily A., Mackey DJ., Olaiya P. Presented at ISOQOL Calgary, October 2023. Winner of the 2023 Outstanding Poster Award Psychometric properties of the Polish version of the FACIT-Sp-12: Assessing spiritual well-being among patients with chronic diseases Machul M., Bredle J., Jurek K., Dobrowolska B. Med Sci Monit. 2023 Nov 16;29:e941769 Achieving Conceptual and Cultural Equivalence in Universal Arabic PROMIS Item Banks Parks-Vernizzi E., Nagy E., Guillen R., Boucher A., Arnold B., Maksud E., Correia H., Bakhsh HR, Bin Sheeha BH, Al-Dhahi M., Al-Hasani R. Presented at ISOQOL Calgary, October 2023. Translation & Linguistic Validation of the FACIT-COST Measuring Financial Toxicity in Cancer Patients Worldwide Savic L., Parks-Vernizzi E., Arnold B., Bredle JM Presented at ISOQOL Calgary, October 2023. Translation & Linguistic Validation of PROMIS SF v2.0 -Physical Function -MS 15a & PROMIS SF v1.0 -Fatigue -MS 8a for use in India & Malaysia Parks-Vernizzi E., Pérez B., Maksud E., Son J., Arnold B., Correia C. Presented at PHO Prague, October 2022. Prev 1 2 3 ... 11 1 ... 1 2 3 4 5 6 7 8 9 10 11 ... 11 Next We look forward to serving your study needs. Contact us to get started! FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.

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

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Download scoring documents for this measure. BACK PROMIS SF v1.0-Dyspnea-Severity Item Bank http://www.healthmeasures.net/score-and-interpret/calculate-scores/scoring-instructions

NFBrSI-24 National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Brain Cancer Symptom Index - 24 Item Version For patients with Brain cancer; A FACT/NCCN-Brain Symptom Index LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The NCCN-FACT Brain Symptom Index-24 (NFBrSI-24) is an index of the symptoms in advanced brain tumors perceived as most important by both patients and clinicians and improves upon existing measures of brain tumor symptoms through better satisfaction of regulatory requirements for measure development. The findings in development suggest good reliability and validity, indicating that the NFBrSI-24 is a promising brief assessment of high priority advanced brain tumor symptoms for research and clinical settings. MEASURE NAME: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Brain Cancer Symptom Index - 24 Item Version (NFBrSI-24) VERSION: 2 NUMBER OF ITEMS: 24 PATIENT POPULATION: Brain 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: Disease-Related Symptoms – Physical, Disease-Related Symptoms – Emotional, Treatment Side-Effects, Function/Well-Being TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores possible. RELATED MEASURES: FACT-Br , FBrSI , FACT-G DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the NFBrSI-24 can be obtained by registering for permission. Users are not permitted to translate the NFBrSI-24 without permission from FACIT.org. Permission from FACIT.org to translate the NFBrSI-24 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 Cella, D., Paul, D., Yount, S., Winn, R., Chang, C-H, Banik, D., & Weeks, J. What are the most important symptom targets when treating advanced cancer? A survey of providers in the National Comprehensive Cancer Network (NCCN). Cancer Investigation 2003; 21(4): 526-535. doi: 10.108/CNV-120022366. Cella, D., Rosenbloom, S., Beaumont, J., Yount, J., Paul, D., Hampton, D., Abernethy, A., Jacobsen, P., Syrjala, K., & Von Roenn, J. Development and validation of 11 symptom indexes to evaluate response to chemotherapy for advanced cancer. Journal of the National Comprehensive Cancer Network; 2011; 9(3): 268-278. doi: 10.6004/jnccn.2011.0026. Lai, J-S. Cella, D. Beaumont, J., Jensen, S. Development of a Symptom Index for Patients with Primary Brain Tumors. Value in Health 2014; 17: 62-69. doi: 10.1016/j.jval.2013.11.006. Rosenbloom, S., Yount, S., Yost, K., Hampton, D., Paul, D., Abernethy, A., Jacobsen, P., Syrjala, K., Von Roenn, J., & Cella, D. Development and validation of eleven symptom indices to evaluate response to chemotherapy for advanced cancer: Measurement compliance with regulatory demands. Farquhar, I., Summers, K., Sorkin, A. (Eds.). The Value of Innovation: Impacts on Health, Life Quality and Regulatory Research. Emerald Group Publishing Inc. 2007; 16: 53-66. doi: 10.1016/S0194-3960(08)16003-6. 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-Br Functional Assessment of Cancer Therapy – Brain LEARN MORE FBrSI Functional Assessment of Cancer Therapy Brain Cancer Symptom Index - 15 Item Version LEARN MORE FACT-G Functional Assessment of Cancer Therapy – General LEARN MORE