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:
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Clinical Outcome Assessments (COA) TranslationMost 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.
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Linguistic ValidationPatients 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.
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eCOA Translation, Adaptation, Migration and Screenshot ProofreadingElectronic 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
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Interview Transcription & TranslationConducting 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.
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Translation of Consent forms, Diaries, Event Logs and ProtocolsAs 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.
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Translatability Assessment and Concept DefinitionCOA 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.