View all available languages for this measure. BACK FAHI Languages Afrikaans Chinese - Traditional Danish Dutch English French German Greek Gujarati Italian Japanese Korean Malay Norwegian Polish Portuguese Romanian Russian Sesotho Spanish Swedish Turkish Thai Ukrainian Urdu Xhosa Zulu

View all available languages for this measure. BACK FACT-Taxane Languages Afrikaans Arabic Bengali Bosnian Chinese - Simplified Chinese - Traditional Czech Danish Dutch English Finnish French German Greek Gujarati Hebrew Hungarian Italian Japanese Kannada Korean Latvian Macedonian Malay Malayalam Marathi Norwegian Polish Portuguese Romanian Russian Serbian Spanish Swedish Tagalog Tamil Thai Turkish

Download scoring documents for this measure. BACK NFBSI-16 Scoring Downloads Download DOC

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

FACIT Measures & Languages SUB-TITLE PLACEHOLDER At FACIT, our passion is the patient. Our mission is providing a voice for patients worldwide. With longstanding academic ties, FACIT is an organization grounded in rigorous health outcomes measurement methods with the aim of improving global health outcomes research. Comprised of two inter-related organizations, FACIT.org and FACITtrans, our multidisciplinary teams provide clients an international pool of talent from a wide variety of academic and clinical resources. In addition to licensing the well-known FACIT system of questionnaires, FACIT.org also licenses several other measures such as the C-Path Clinical Outcomes Assessments (COA’s). Our team at FACITtrans provides translation services of unsurpassed quality to the international clinical research community. Since 1994, the team at FACITtrans has served as a pioneer in the translation and linguistic validation of COA’s and other international clinical trial documents, serving on several Special Interest Groups (SIG’s) and contributing to the body of science and literature of cross-cultural health assessment. Our Vision As part of a cutting edge health outcomes research program, the application of our knowledge and resources serve the patient's interests. We make a difference in patients’ lives by ensuring their perspective of their disease or treatment is measured and conveyed in a culturally, semantically and linguistically appropriate manner. Our services contribute to improved quality of life for patients and aid clinicians in solving complex healthcare challenges, thus providing value to our clients and contributing to their growth. We fulfill this vision by fostering collaborations based on state of the art science, respect, integrity and compassion with our colleagues in academia and the pharmaceutical industry. Our international staff of devoted project managers, linguists and clinicians take each of these challenges to heart. Our Values In a position of service to patients, researchers and clinicians, we hold the following tenets as integral to our success: Quality systems underpinning all processes to ensure our translations say what they mean, and mean what they say. Adherence to the highest scientific principles. Integrity and ethical conduct in all business and interpersonal transactions. Respect and appreciation for our colleagues, clients, vendors and patients. Fostering of long term relationships based on respect, trust and understanding of mutual needs. Fiscal responsibility. Our Team Responsive interdisciplinary expertise grounded in academic science. FACIT.org TEAM FACITtrans TEAM Our History Over 25 years of improving patient health status measurement and methodologically rigorous COA translations. FACIT.org HISTORY FACITtrans HISTORY

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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 Services PATIENT FOCUSED, QUALITY DRIVEN As pioneers in the field of translation and linguistic validation of health outcome measures, we uphold our reputation for high quality work, attention to detail, and excellent customer service on every project. We offer a wide range of services for your studies: COA Development Consultation: Translatability Assessment In-trial Interviews COA Translation & Linguistic Validation Interview Transcription and Translation Translation of Consent Forms and Protocols eCOA Adaptation and Migration COA Development COA Development Consultation: Translatability Assessment 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. COA Translation & Linguistic Validation COA Translation & 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. Translation of Consent Forms & Protocols Translation of Consent Forms and Protocols As longtime members of an academic research community we are well versed in the administrative and legal requirements of clinical trial research. We offer tailored translation approaches to handle the 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. In-trial Interviews In-trial Interviews High-quality qualitative research depends on experienced interviewers who can engage with participants professionally while maintaining study integrity. Through our In-trial Interviews – Interviewer Services, FACITtrans coordinates trained interviewers to support structured interviews as part of clinical and outcomes research. All interviewers are carefully vetted by FACITtrans for professionalism, ethical awareness, confidentiality and sound judgment. Clients provide study-specific training to ensure alignment with research protocols, while FACITtrans manages scheduling and coordination with participants. Interview recordings are securely transferred to the client’s designated platform, and training for clinical sites can also be supported when needed. Interview Transcription and Translation Interview Transcription and Translation Conducting interviews in other countries, and 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. eCOA Adaptation and Migration eCOA Adaptation and Migration Electronic Clinical Outcome Assessment (eCOA) captures data electronically in clinical trials. COA measures that were developed for pen and paper administration must be adapted for electronic delivery, and often some adjustments to the measure's instructions or layout are needed. 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 eCOA 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 We look forward to serving your study needs. Learn more and Contact us to get started! FAQ How do I obtain permission to use one or more of the FACIT scales? Is there a fee for use? Do I need permission to duplicate the form for use in a research project or clinical setting? When do I have to complete the registration? Frequently Asked Questions 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.

FACIT Translation & Linguistic Validation Methodology First published in 1996 and adopted by the HealthMeasures family of measurement systems (Patient-Reported Outcomes Measurement Information System (PROMIS®); Quality of Life in Neurological Disorders (Neuro-QoL); NIH Toolbox; as well as the Critical Path Institute's PRO Consortium; the FACIT Translation and Linguistic validation methodology emphasizes a “universal” translation approach in order to achieve a single, valid translation for each language, designed to work across different countries that speak the same language. The universal approach provides several advantages to a country-specific approach that produces multiple same-language versions across different countries. These advantages include the following: (1) enables language subgroup comparison, without requiring a check on bias introduced by different translations (e.g., comparing Spanish-speaking groups in the United States to one another or to people in Spain or Latin America); (2) minimizes bias introduced by multiple, country-specific translations in a project or trial; (3) simplifies logistics and analysis of multinational clinical trials; and (4) facilitates survey administration in the case of migrating populations. In cases requiring a universal translation, the standard methodology is modified during the translation and review steps and in cognitive debriefing to include native linguists from each relevant country. This is a more rigorous version of the double-back-translation method considered superior to single translation and translation by committee (Bonomi et al., 1996). The process is summarized as follows: For each target language, the source is translated by two independent professional translators. Next, a third independent translator reconciles the two forward translations by choosing the better of the two forward translations and resolving discrepancies between them. This reconciled version is then back-translated blindly by a native English-speaking translator fluent in the target language. The developer reviews the back-translation for discrepancies from the source version and to assess equivalence with the source. Subsequently, an additional independent review/finalization is performed by a native speaking linguist and harmonization with other existing translations is conducted by the developer in conjunction with the linguist. Finally, the target-language version is pretested with patients in the country in which the language is spoken. If any items are found to be problematic by patients, their feedback allows for modifications in the translations and for indications of changes that may later be made to the original source document, an example of the decentering process (Lent, Hahn, Eremenco, Webster, & Cella, 1999). The Universal Approach: For languages native to multiple countries, representatives from each country work together in conjunction with FACIT to develop one version of an item valid for use in every country a language is spoken, rather than country-specific versions. Learn more about FACITtrans’ services All items in the FACIT Measurement System undergo this methodology and FACITtrans is the only vendor authorized to translate and linguistically validate FACIT items. Permission to translate any FACIT item or measure should be obtained prior to undertaking this methodology. Contact us for more details. If permission has not been obtained, the item or scale will not be recognized as part of the FACIT measurement system.

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View all available languages for this measure. BACK NFLSI-17 Languages Afrikaans Arabic Chinese - Simplified Chinese - Traditional Czech Danish Dutch English Finnish French German Hebrew Hungarian Italian Japanese Korean Malay Norwegian Polish Portuguese Russian Spanish Swedish Turkish

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