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FAHI Functional Assessment of HIV Infection LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview Below are the details for the FAHI measure: MEASURE NAME: Functional Assessment of HIV Infection (FAHI) VERSION: 4 NUMBER OF ITEMS: 47 PATIENT POPULATION: HIV patients 18 years and older RECALL PERIOD: Past 7 days RESPONSE SCALE: 5 point Likert-type scale DATA COLLECTION: Paper and electronic ADMINISTRATION: Self-administration and interview when applicable SUBSCALE DOMAINS: Physical Well-Being, Emotional Well-Being/Living with HIV, Functional and Global Well-Being, Social Well-Being, Cognitive Functioning TIME FOR COMPLETION: 10-15 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores available. SAS/SPSS algorithms available. RELATED MEASURES: FAMS , FACIT-Dyspnea , FACIT-TB DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FAHI can be obtained by registering for permission. Users are not permitted to translate the FAHI without permission from FACIT.org. Permission from FACIT.org to translate the FAHI 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., Gilet, H., Viala-Danten, M., Peeters, K., Dubois, D., & Martin, S. Effects of etravirine versus placebo on health-related quality of life in treatment-experienced HIV patients as measured by the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) questionnaire in the DUET trials. HIV Clinical Trials 2010; 11(1): 18-27. doi: 10.1310/hct1101-1. Hasanah, C., Zaliha, A., Mahiran, M. Factors influencing the quality of life in patients with HIV in Malaysia. Quality of Life Research 2010; 20(1): 91-100. doi: 10.1007/s11136-010-9729-y. Peterman, A.H., Cella, D., Mo, F., & McCain, N. Psychometric validation of the revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument. Quality of Life Research 1997; 6(6): 572-584. doi: 10.1023/a:1018416317546. Viala-Danten, M., Dubois, D., Gilet, H., Martin, S., Peeters, K., & Cella, D. Psychometric evaluation of the Functional Assessment of HIV Infection (FAHI) questionnaire and its usefulness in clinical trials. Quality Of Life Research.2010; 19(8): 1215-1227. doi: 10.1007/s11136-010-9674-9. 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 FAMS Functional Assessment of Multiple Sclerosis LEARN MORE FACIT-Dyspnea Functional Assessment of Chronic Illness Therapy - Dyspnea-10 item LEARN MORE FACIT-TB Functional Assessment of Chronic Illness Therapy - Tuberculosis LEARN MORE

BACK PROMIS Item Bank v1.0 Dyspnea Severity English Downloads Download PDF Download DOC

BACK FACT-B Languages Afrikaans Arabic Armenian Bengali Bosnian Bulgarian Burmese Cebuano Chinese - Simplified Chinese - Traditional Croatian Czech Danish Dutch English Estonian Farsi Finnish French German Greek Gujarati Haitian Creole Hebrew Hindi Hungarian Indonesian Italian Japanese Kannada Korean Latvian Lithuanian Macedonian Malay Malayalam Maltese Marathi Norwegian Odia Polish Portuguese Punjabi Romanian Russian Sepedi Serbian Slovak Slovene Spanish Swedish Tagalog Tamil Telugu Thai Turkish Ukrainian Urdu Vietnamese Wolof Xhosa Zulu

FACT-Cx Functional Assessment of Cancer Therapy – Cervix For patients with cancer of the Cervix LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview Below are the details for the FACT-Cx measure: MEASURE NAME: Functional Assessment of Cancer Therapy – Cervix (FACT-Cx) VERSION: 4 NUMBER OF ITEMS: 39 PATIENT POPULATION: Cervical cancer patients 18 years and older RECALL PERIOD: Past 7 days RESPONSE SCALE: 5 point Likert-type scale DATA COLLECTION: Paper and electronic ADMINISTRATION: Self-administration and interview when applicable SUBSCALE DOMAINS: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Cervical Cancer Subscale TIME FOR COMPLETION: 10-15 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores, total scores and TOI scores possible. SAS/SPSS algorithms available. RELATED MEASURES: FACIT-CD , FACT-V , FACT-En DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-Cx can be obtained by registering for permission. Users are not permitted to translate the FACT-Cx without permission from FACIT.org. Permission from FACIT.org to translate the FACT-Cx 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 Ashing-Giwa, K. Enhancing physical well-being and overall quality of life among underserved Latina-American cervical cancer survivors: feasibility study. Journal of Cancer Survivorship: Research and Practice 2008; 2(3):215-223. doi: 10.1007/s11764-008-0061-2. Chase, D., Huang, H., Wenzel, L., Cella, D., McQuellon, R., Long, H., Moore, D., & Monk, B. Quality of Life and survival in advanced cervical cancer: A Gynecologic Oncology Group Study. Gynecologic Oncology 2012; 125(2): 315-319. doi: 10.1016/j.ygyno.2012.01.047. Long, H., Bundy, B., Grendys, E., Benda, J., McMeekin, D., Sorosky, J., Miller, D., Eaton, L. & Fiorica, J. Randomized Phase III Trial of Cisplatin With or Without Topotecan in Carcinoma of the Uterine Cervix: A Gynecologic Oncology Group Study. Journal of Clinical Oncology 2005; 23(21): 4626-4633. doi: 10.1200/JCO.2005.10.021. Monk, B., Sill, M., McMeekin, D., Cohn, D., Ramondetta, L., Boardman, C., Benda, J., & Cella, D. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a gynecologic oncology group study. Journal of Clinical Oncology 2009; 27(28): 4649-4655. doi: 10.1200/JCO.2009.21.8909. 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-CD Functional Assessment of Chronic Illness Therapy - Cervical Dysplasia LEARN MORE FACT-V Functional Assessment of Cancer Therapy – Vulva LEARN MORE FACT-En Functional Assessment of Cancer Therapy – Endometrial LEARN MORE

Label Claims LABEL CLAIM INFORMATION RELEVANT TO BOTH FACIT MEASURES AND FACITtrans’ TRANSLATIONS What is a label claim? In the US, the Food and Drug Administration (FDA) is responsible for oversight of medicinal products; the concurrent European Union (EU) organization is called the European Medicines Agency (EMA or EMEA). The package inserts accompanying a drug list all of the medicine’s risks and benefits so that patients and their caregivers are informed of them. In the US these inserts are called “labels”; in Europe they’re called “SmPCs”. The label’s content represents the formal, legal representation of what the drug can and cannot do, including side effects and potential hazards or toxicities. The label establishes the legal boundaries of what the medicine’s developers can promote (or “claim”) about its effects. Given the huge investment pharmaceutical companies make in each drug, the stronger their label claim , the better their chances their drug will be received by clinicians and patients. How does the FDA view the use of PRO’s in label claims? In 2009 the FDA released its Guidance for Industry, Patient Reported Outcomes: Use in Medical Product Development to Support Labeling Claims (PRO guidance) https://www.fda.gov/media/77832/download providing specific directives related to how PRO data can be used in a product’s label. A central tenet of the Guidance is that the PRO measure must demonstrate that it measures the construct on which the label claim is based. For example, if the pharma sponsor is hoping for a label claim that its drug improves patient quality of life (QoL) and functionality by reducing fatigue, it must use a PRO measure which has demonstrated it is a valid and reliable measure that is sensitive to changes in fatigue. The sponsor must concurrently demonstrate a correlation between fatigue and QoL Where do Clinical-Outcome-Assessment (COA’s) fit into label claims? COA’s and Patient Reported Outcome (PRO) Measures in particular, have become widely accepted as valid tools to incorporate in clinical trials to measure the patient’s perspective of his or her disease, treatment, condition or symptom. PROs are widely used in clinical trials to help sponsors differentiate their drug from others that may clinically perform similarly to other drugs. In many cases PRO’s can provide sensitive data for conditions that are not necessarily cured (like side effects), but instead might be mitigated to the point where the patient’s quality of life (QOL) or functional ability is enriched. These can be critical parameters to patients with chronic conditions; having a label claim which states that some aspect of life quality is improved while taking that drug can boost sales significantly. From a statistical perspective, a PRO label claim can be based upon primary, secondary or (in some rare cases) exploratory study aims. Using PRO data as a primary endpoint requires that a direct link be established between the change in patient score and the disease, condition or symptom being treated. Using PRO data as a secondary study endpoint would mean that the PRO data would be used as either secondary to improvement in a clinical indication (i.e. the disease would be cured) OR to demonstrate there are other treatment benefits. An exploratory analysis is not typically used for labeling but may result in evidence or data that another study is warranted which focuses on a new finding. Per Gnanasakthy et al (2012 ) the majority of PRO label claims granted have been primary endpoints focused on symptoms. How does the EMA view the use of PRO’s in label claims? The EMA issued a reflection paper in 2005 which did not provide specific requirements, but rather was intended more as a reference document to provide some broad recommendations and context for the incorporation of Health- Related Quality of Life (HRQL) into the drug evaluation process. The FDA and EMA have differing standards for the use of PRO’s for labeling purposes. The FDA has strict recommendations requiring the validity of the construct being measured and also focuses more on clinical symptoms. The FDA also has more rigorous study design and analysis requirements. The EMA is more flexible with regard to open label studies and more amorphous patient-reported perspectives. Perhaps because of this, the EMA permitted more label claims in oncology trials from 2012-2016. During this period, according to Gnanasakthy et al ( 2019 ), 49 oncology drugs across 64 indications were approved by the EMA, however “no FDA labeling was identified.” It should be noted that the FDA’s Oncology Division has reviewed and approved PRO label claims for indications outside cancer, and other FDA divisions outside of oncology have approved PRO label claims. We note that the EMA views FACIT measures favorably in oncology trials. Gnanasakthy et al (2019) note “A Functional Assessment of Cancer Therapy (FACT) measure was included in 12 (26.6%) submissions and led to labeling for 8 (38.1%) indications. Notably, FACT measures led to a proportionately greater share of EMA PRO labeling when included in a submission (8 of 12 [66.7%]) as compared to EORTC measures (9 of 26 [34.6%]). These 2 commonly used measures with their disease-specific modules were granted PRO labeling in two-thirds of reviews (14 of 21 [66.6%]).” What measures has FACITtrans translated that were used in label claims? FACITtrans has performed all the translations and linguistic validation for any FACIT measure so we are pleased to have contributed to any of our clients’ label claims that included a FACIT questionnaire in their QOL endpoint. An overview of FACIT measures used in label claims can be found here . Confidentiality obligations do not permit us to specify which drugs used non-FACIT PRO’s translated by FACITtrans. Because we have been in this clinical trial “space” for nearly three decades, we are pleased to have contributed to many clients’ successful PRO label claims submissions. We can also state that as a preferred translation partner of the PROMIS instruments, we have collaborated in several studies’ multinational PROMIS claims submissions. The FACIT Group would like to specifically and gratefully acknowledge the contributions of Ari Gnanasakthy, M.Sc. at RTI Health Solutions and his colleagues who publish periodically on PRO’s in label claims.

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COA Management & Licensing Services QUESTIONNAIRE LICENSING SERVICES With over 25 years of licensing and Intellectual Property (IP) management experience, we can optimize your measure’s exposure and support its use within the HEOR and QOL scientific communities. Why choose FACIT.org as your licensing partner? Simple We make it easy . All licensing and related infrastructure tasks are coordinated at one source. Flexible Flexible terms . Measurement ownership by FACIT.org or the original copyright holder. Shared licensing and distribution fees possible. Support Support you need . FACIT.org provides users all scoring, interpretation and relevant publications, and all general Q&A support for measure implementation. Service Unparalleled customer service . At FACIT.org, we are always open to measure-specific needs, questions or adaptations. We Offer... Dynamic Partnership FACIT.org can either incorporate your measure into our existing structure or develop a new measure-specific infrastructure. Measurement Promotion License and distribute English/source language versions to users at no fee. Research-centric License for academic and non-profit clinical use of any language version is provided at no fee. No Repeat Costs After an initial translation fee for pharma-sponsored trials, subsequent uses of said translation(s) are free of charge to the sponsor. A licensing fee applies to for-profit requests by companies who are not the original sponsor. Cooperation While FACIT.org charges a licensing fee to for-profit users who request translated versions, we can sometimes adapt fees if required by the IP developer. View Additional Measures We License We look forward to hearing from you to assist in supporting the licensing and distribution of your validated instrument! Contact Our Licensing Team About Managing Your Measure

The FACIT Searchable Library The FACIT Measurement System is 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. These measures are comprised of over 700 unique items appropriate for use with adults aged 18 and over, and more than 130 items appropriate for children ages 8-18. Most FACIT items have demonstrated face and content validity, and were created with direct input from patients and expert clinicians. Many items have also been translated into nearly 80 languages (reaching over 100 countries) using a standardized, rigorous translation methodology and tested for comprehension by native speakers. 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. Until 2017, people used these items via static FACIT questionnaires in a fixed, validated format. Now, with the introduction of the FACIT Searchable Library, 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. Two recent trends have led us to provide this new approach: One is the introduction of item response theory (IRT) into health measurement. One of the guiding principles of IRT measurement is the basic ‘fungibility’ of items measuring the same underlying concept, or domain. In an IRT-calibrated item bank, one can “pick-and choose” items from that bank, according to their content relevance in a given setting. The score obtained is generalizable to other studies or samples that may have used a different set of items from the same bank. Given this, the introduction of IRT into health measurement has led to the question of whether or not more classically-developed measurement systems such as FACIT could consider the value of customized individual item selection. Some FACIT items have become incorporated into or linked with national item banks such as PROMIS and Neuro-QoL, and these could indeed be scored on those national metrics. However, most FACIT items have not been incorporated or linked to existing IRT item banks and would therefore not be able to produce interpretable scores beyond the single item raw score, which is the starting point for most custom forms. The second trend leading to this new approach has been increasing pressure from government and private sectors, including patient advocates, to ask only those questions that are directly relevant to the hypothesis of a given study or treatment comparison. This pressure has been growing for several years, culminating in the release of the National Cancer Institute’s Patient Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE), which is a set of 124 items that query 78 symptom terms from the larger (clinician-rated) CTCAE v4.0. The FACIT Searchable Library covers all of the PRO-CTCAE major categories, maps to 55 of its 78 symptom terms, and addresses several other disease symptoms and treatment adverse events. Similar to how the PRO-CTCAE is deployed, any user could sample questions from the FACIT Searchable Library and evaluate, in descriptive fashion, how one treatment compared to another, on an item-by-item basis. Below are five easy steps to build a custom assessment from the FACIT Searchable Library: Step 1: Educate yourself on the content of the item library. Search by Symptom, Function, General Perceptions, or Other. Or search by PRO-CTCAE category for comparison. Step 2: Evaluate the fit of item content to your research goal. Think in terms of item content, relevance, readability, and language availability. Step 3: Using the ‘Build-a-PRO’ function, create a custom form in English. Register to request permission for use. Step 4: Validate your new questionnaire with data you collect as to its scalability and responsiveness. Step 5: Publish your results and cite the FACIT Searchable Item Library as your source for items. Some frequently asked questions: 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. Standardized static, validated FACIT questionnaires range in length from 4-60 items. 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. But custom form development may be useful for some researchers in need of a novel, functional method for more targeted assessment. To explore the FACIT Searchable Library and its potential for custom generated forms using FACIT items, click below. By clicking below, you will be directed to the FACIT Searchable Library section of our website. You can find more specific information about the FACIT Searchable Library in the FAQ’s section. We hope you find this latest iteration of our measurement system as interesting as we do. Go To The FACIT Searchable Library

FACT-Taxane Functional Assessment of Cancer Therapy – Taxane For patients receiving Taxane therapy LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview Below are the details for the FACT-Taxane measure: MEASURE NAME: Functional Assessment of Cancer Therapy – Taxane (FACT-Taxane) VERSION: 4 NUMBER OF ITEMS: 43 PATIENT POPULATION: Cancer patients 18 and older receiving taxane therapy RECALL PERIOD: Past 7 days RESPONSE SCALE: 5 point Likert-type scale DATA COLLECTION: Paper and electronic ADMINISTRATION: Self-administration and interview when applicable SUBSCALE DOMAINS: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Taxane Therapy Subscale TIME FOR COMPLETION: 10-15 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores, total scores and TOI scores possible. SAS/SPSS algorithms available. RELATED MEASURES: FACT/GOG-NTX, FACT/GOG-NTX-4 , FACT/GOG-NTX-12 , FACT/GOG-NTX-13 DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACT-Taxane can be obtained by registering for permission. Users are not permitted to translate the FACT-Taxane without permission from FACIT.org. Permission from FACIT.org to translate the FACT-Taxane 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., Peterman, A., Hudgens, S., Webster, K., & Socinski, M. Measuring the side effects of taxane therapy in oncology: The Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane). Cancer2003; 98(4): 822-831. 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/GOG-NTX Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity LEARN MORE FACT/GOG-NTX-4 Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 4 Item Version LEARN MORE FACT/GOG-NTX-12 Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 12 Item Version LEARN MORE

BACK PROMIS SF v1.0-Dyspnea-Functional Limitations 10a English Downloads Download PDF Download DOC