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Download scoring documents for this measure. BACK FACT-CSI Scoring Downloads Download DOC - FACT-CSI Download DOC - FACT-GINET Download DOC - FACT-LNET Download DOC - FACT-PNET

FACT-CSI and FACT-NET Functional Assessment of Cancer Therapy - Carcinoid Syndrome Symptom Index For patients with carcinoid syndrome LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview The FACT-CSI is a 24-item instrument for patients with carcinoid syndrome that can be scored as a single, multidimensional symptom index, or sub-scored by domain (disease-related physical symptoms, disease-related emotional symptoms, treatment side effects, and functional well-being), meeting FDA guidance recommendations while allowing maximum flexibility for both global and targeted symptom evaluation. Its development followed FDA guidelines for the patient-reported outcome measures, which emphasizes improvement in tumor-related symptoms or delays in symptom progression as evidence of clinical benefit for patients in oncology drug trials. Methods consistent with the FDA guidance were utilized along with prior experience developing 11 National Comprehensive Cancer Network (NCCN) symptom indexes to identify the highest priority symptoms and concerns of patients with GINET, PNET, and LNET, and of patients with CS, to inform the development of a set of NET symptom indexes appropriate for use in both clinical trial and clinic settings. MEASURE NAME: Functional Assessment of Cancer Therapy - Carcinoid Syndrome Symptom Index (FACT-CSI) / FACT-NET VERSION: 4 NUMBER OF ITEMS: FACT-CSI - 24 items FACT-GINET - 18 items FACT-GINET + CSI - 29 items FACT-LNET - 17 items FACT-LNET + CSI - 30 items FACT-PNET - 19 items FACT-PNET + CSI - 29 items PATIENT POPULATION: Patients 18 years and older with carcinoid syndrome, GINET, PNET or LNET 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: CSI, GINET, LNET, PNET TIME FOR COMPLETION: 5-10 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores possible. RELATED MEASURES: FACT-Ga , FACT-Hep , FACT-L DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-CSI can be obtained by registering for permission. Users are not permitted to translate the FACT-CSI without permission from FACIT.org. Permission from FACIT.org to translate the FACT-CSI 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 Shaunfield S, Webster K, A, Kaiser K, Greene G, J, Yount S, E, Lacson L, Benson A, B, Halperin D, M, Yao J, C, Singh S, Feuilly M, Marteau F, Cella D: Development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index. Neuroendocrinology 2021;111:850-862. doi: 10.1159/000511482. 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-Ga Functional Assessment of Cancer Therapy – Gastric LEARN MORE FACT-Hep Functional Assessment of Cancer Therapy – Hepatobiliary LEARN MORE FACT-L Functional Assessment of Cancer Therapy – Lung LEARN MORE

Download this measure in English. BACK FACIT-Dyspnea Item Bank English Downloads Not available

View all available languages for this measure. BACK FACIT-Pal Languages Bengali Burmese Chinese – Simplified Dutch English Farsi German Greek Hindi Indonesian Japanese Malay Malayalam Portuguese Sinhala Spanish Swahili Tagalog Tamil Telugu Thai Turkish Vietnamese

Download scoring documents for this measure. BACK FACIT-SWiP Scoring Downloads Download DOC

View all available languages for this measure. BACK FACT-CSI Languages Czech Danish Dutch English French German Greek Hungarian Italian Polish Portuguese Spanish Swedish

Download scoring documents for this measure. BACK NFBlSI-18 Scoring Downloads Download DOC

Download this measure in English. BACK FACIT-Pal English Downloads Download PDF Download DOC

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: Linguistic Validation Translatability Assessment Translation of Consent Forms and Protocols Interview Transcription and Translation eCOA Adaptation and Migration We look forward to serving your study needs. Contact us to get started! Frequently asked questions Expertise FAQ 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 and 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. FAQ 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.

Over 25 years of methodologically rigorous COA translations. FACITtrans History OVER 25 YEARS OF METHODOLOGICALLY RIGOROUS COA TRANSLATIONS 1994 1996 2000 2001 2004 2005 2009 2012 2017 2021 1993 1993 1993 Patient perspective on effects of cancer treatment gain recognition As part of increasing interest from the international clinical and research communities to assess the patient's perspective of his or her disease, David Cella, Ph.D. publishes the original manuscript on his development of the Functional Assessment of Cancer Therapy FACT-G. 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. 1994 1994 Clinicians request the FACT-G in Spanish Careful consideration of equivalence and quality are at the forefront of this endeavor. The translation group that will become FACITtrans is born. 1996 1996 A call to quality within the PRO/HRQOL community The initial manuscript on the translation and linguistic validation of the FACT scale is published. 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. 2000 2000 The translation group’s work gains recognition The first requests to translate COAs by other developers begin. 2001 2001 The translation group publishes an article, and causes a stir Our translation group develops the first iteration of an article in support of the universal translation approach, which 20 years later is still considered methodologically novel. Advantages of the Universal Approach: Enables comparisons across subgroups, assuming the scale applied is unbiased (e.g. Spanish speaking populations in the US). Minimizes bias introduced by multiple translations in a survey or clinical trial. Reduces logistical complexity in multinational clinical trials. Facilitates survey administration in the case of migrating populations. 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 2004 Item banking translation begins Item banking translation begins with the PROMIS into Spanish. 2005 2005 Our translation group contributes to landmark ISPOR translation and cultural adaptation guidelines The result is the seminal manuscript, “Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient‐Reported Outcomes (PRO)” . Translation companies rush to adopt this methodology that is now accepted as industry standard. 2009 2009 The translation and formatting team formerly part of CORE becomes FACITtrans The transition from academia to a business environment frees our group to be even more responsive and streamlined, permitting more effective response times and quicker turnaround for the deadline-driven pharmaceutical clinical trial industry. Under the scientific direction of Dr. Cella, the outcomes scientists at MSS and the translation and formatting team of FACITtrans have world-class experience and expertise in translation and linguistic validation, outcomes research design, database development, multicenter data collection and management, psychometrics and statistics. 2012 2012 Adapt FACIT measures for electronic administration The FACIT Group starts to modify text for FACT and FACIT questionnaires’ use on tablets and other devices. 2017 2017 FACITtrans earns ISO 9001:2015 certification Quality processes have always been central to our work, which is why we co-founded the ISPOR translations guidelines so many years ago. In 2017 we went a step further to seek recognition on an international level for how we work. This resulted in a very rewarding moment when we received praise from the auditing agency and our ISO 9001:2015 certification. 2021 2021 FACITtrans earns ISO 17100:2015 certification Harnessing the energy from our ISO 9001:2015 certification, we placed our translation and linguistic validation processes under additional scrutiny to earn our ISO 17100:2015 certification, further reinforcing our high quality work. Today Today Collaboration is our strength While most of our work is for top pharmaceutical companies, we regularly partner with Dr. Cella’s research program at Northwestern University - the largest academically-based outcomes research group in the world. We also collaborate on NIH initiatives such as PROMIS, and with industry leaders like C-Path. Our President, Benjamin Arnold, and Executive Director, Emily Parks-Vernizzi, served as Co-Chairs during separate terms, and are now permanent steering committee members of ISOQOL’s Translation and Cultural Adaptation Special Interest Group (TCA-SIG). 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.

Most questions can be answered in out very informative FAQ section. Check there first! How can we help you? Most questions can be answered right here on the site. See if your answers are in the categories below. General Selecting a Measure Populations Administering Questionnaires Formatting Statistical User Permission Multilingual Translations Not finding what you're looking for? Contact Us .

Scoring OF THE FACIT MEASURES For all FACIT measures, higher scores are better than lower scores. This is true whether measuring a symptom or a functional ability. All FACIT measures use raw total scoring approach without subsequent transformation. Scoring recommendations permit for a variety of component and composite calculations, depending on the desired outcome assessment, meeting FDA guidance recommendations for both global and targeted symptom evaluation. For any FACIT measure, subscale scores are calculated by first reversing negatively stated-items (subtracting the response from ‘4’) and then summing the raw (0-4) scores. A total score is then derived by summing subscale scores. For example, a total FACT-G score is obtained by summing individual subscale scores PWB + EWB + SWB + FWB. Total scores for the disease-, treatment-, and condition-specific subscales are typically obtained by summing all subscale scores PWB + EWB + SWB + FWB + additional concerns subscale. The scoring templates provided for each measure simplify this process by providing a framework to reverse score relevant items and prorate for missing data. TOI The TOI can be computed for any FACIT disease-, treatment-, or condition-specific scale. It is the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and additional concerns subscales. Our experience with this TOI endpoint is that it is an efficient summary index of physical/functional outcomes. It is therefore a common endpoint used in clinical trials, because it is responsive to change in physical/functional outcomes, sometimes more than a total (overall) multidimensional aggregated score, which includes social and emotional well-being. While social and emotional well-being are very important to quality of life, they are not as likely to change as quickly or dramatically over time or in response to physical health interventions such as pharmaceutical treatments in clinical trials. Missing Data Relevant scoring options are outlined on each measure’s scoring template, where calculating reverse scored items and prorating for missing data has been integrated. In cases where individual items are skipped, subscale scores can be prorated using the average of the other answers in the scale. This is acceptable as long as more than 50% of the items were answered in the subscale (e.g., a minimum of 4 of 7 items, 4 of 6 items, etc.). The total score is then calculated as the sum of the un-weighted subscale scores. A FACIT measure is considered to be an acceptable indicator of patient quality of life as long as overall item response rate is greater than 80% (e.g., at least 22 of 27 FACT-G items completed). This is not to be confused with individual subscale item response rate, which allows a subscale score to be prorated for missing items if greater than 50% of items are answered. In addition, a total score should only be calculated if ALL of the component subscales have valid scores. Scoring is intended to be completed by research and clinical staff rather than patients themselves. Raw scoring templates are available in English and electronic scoring options are currently not available from FACIT.