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View all available languages for this measure. BACK peds FACIT-F Languages Afrikaans Arabic Bengali Bulgarian Catalan Cebuano Chinese - Simplified Chinese - Traditional Croatian Czech Danish Dutch English Estonian Finnish French Georgian German Greek Gujarati Hebrew Hindi Hungarian Italian Japanese Kannada Khmer Korean Latvian Lithuanian Malay Malayalam Marathi Norwegian Polish Portuguese Punjabi Romanian Russian Serbian Slovak Slovene Spanish Swedish Tagalog Tamil Telugu Thai Turkish Urdu Vietnamese Xhosa Zulu

View all available languages for this measure. BACK FACT-O Languages Afrikaans Arabic Armenian Bengali Bulgarian Cebuano Chinese – Simplified Chinese – Traditional Croatian Czech Danish Dutch English Estonian Finnish French Georgian German Greek Gujarati Hebrew Hindi Hungarian Indonesian Italian Japanese Kannada Korean Latvian Lithuanian Malay Malayalam Marathi Norwegian Odia Polish Portuguese Romanian Russian Serbian Slovak Slovene Spanish Swedish Tagalog Tamil Telugu Thai Turkish Ukrainian Urdu Vietnamese

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Download this measure in English. BACK FACT-CSI English Downloads Download PDF - FACT-CSI Download DOC - FACT-CSI Download PDF - FACT-GINET Download DOC - FACT-GINET Download PDF - FACT-LNET Download DOC - FACT-LNET Download PDF - FACT-PNET Download DOC - FACT-PNET

FACIT-TB Functional Assessment of Chronic Illness Therapy - Tuberculosis For patients with tuberculosis LICENSE THIS MEASURE Overview Language Availability Licensing Selected References Related Measures Overview Overview Initially developed and validated in Arabic, the FACIT-TB incorporates items relevant to tuberculosis patients from the FACIT Searchable Library into the FACT-G. MEASURE NAME: Functional Assessment of Chronic Illness Therapy - Tuberculosis VERSION: 1 NUMBER OF ITEMS: 45 PATIENT POPULATION: Tuberculosis 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, Spiritual Well-Being TIME FOR COMPLETION: 10-15 minutes SCORING: Manual scoring template, some items are reverse scored. Subscale scores and total scores possible. RELATED MEASURES: FACT-G , FAHI , FAMS DOWNLOAD MEASURE IN ENGLISH DOWNLOAD SCORING DOCUMENT Language Availability Available translations of the FACIT-TB can be obtained by registering for permission. Users are not permitted to translate the FACIT-TB without permission from FACIT.org. Permission from FACIT.org to translate the FACIT-TB 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 Dujaili J.A., Syed Sulaiman S.A., Hassali M.A., Blebil A.Q., Awaisu A., Bredle J.M. Development and psychometric properties of a tuberculosis-specific multidimensional health-related quality-of-life measure for patients with pulmonary tuberculosis. Value in Health Regional Issues 6C (2014): 53-59. Dujaili J.A., Syed Sulaiman S.A., Hassali M.A., Awaisu A., Blebil A.Q., Bredle J.M. Health-related quality of life as a predictor of tuberculosis treatment outcomes in Iraq. International Journal of Infectious Diseases 2014; (31): e4–e8. Dujaili J.A., Syed Sulaiman S.A., Awaisu A., Hassali M.A., Blebil A.Q., Bredle J.M. Comparability of interviewer-administration versus self-administration of the Functional Assessment of Chronic Illness Therapy – Tuberculosis (FACIT-TB) health-related quality of life questionnaire in pulmonary tuberculosis patients. Pulmonary Therapy (2016) 2:127-137. 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-G Functional Assessment of Cancer Therapy - General LEARN MORE FAHI Functional Assessment of HIV Therapy LEARN MORE FAMS Functional Assessment of Multiple Sclerosis LEARN MORE

Label claims information relevant to both FACIT measures and FACITtrans' translations. 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.

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

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