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. Some of these questionnaires are disease-specific (e.g., cancer, multiple sclerosis, HIV disease), some are related to specific treatment-related toxicities (e.g., central or peripheral neurotoxicity, gastrointestinal toxicity), some are symptom focused (e.g., pain, fatigue), others address physical, mental and social function, and still others assess mood and well-being. In all, there are more than 700 unique questions aimed at adults over age 18, and more than 130 questions aimed at children ages 8-17. Many of these questions are translated into several languages; some as many as 70 languages. Every question in the FACIT item library was created with direct input from patients and expert clinicians, and tested for comprehension by native speakers of the languages in which each item has been translated.
Until 2017, people using the FACIT Measurement System have been expected to use a FACIT questionnaire in its fixed, validated format. Item length of the more than 100 fixed-format FACIT questionnaires varies from 4-60 questions. 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.
Now, with the introduction of the FACIT Searchable Library, one is able to create a custom form using the site’s Build-a-PRO function, including only those FACIT questions that are relevant to one’s study or purpose. While doing so does not instantly “validate” the custom composition, it does create an opportunity to target ones inquiry with questions that have been developed with patient input, and 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 SIL 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.
So, to get you started, here 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 other languages.
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.
Using Build-a-PRO to generate a custom form
Build a custom patient-reported outcome (PRO) form using individual FACIT items.
Use the search function to find FACIT individual items. Select items for your form, sort by order of appearance, add subscale heading(s), and click a button to generate a formatted copy of your custom PRO form (available in English only).
Search & add items
- Use the search function to find FACIT measures or individual items relevant to your area of interest
- In the search results, click on the FACIT measure name (e.g. The Functional Assessment of Cancer Therapy-General) to see that measure’s individual items OR click on an individual item name (e.g., I have fatigue) to see more information about the item
- When viewing items (in measures or individually), click on “add to Build-a-PRO” for any item you want to include in your custom form
- To see more items, click on the ‘Search Results’ tab, or start a new search, adding additional items if desired
- Use the “Previous Search’ tab to view previous searches
- Once all items have been selected, click on the Build-a-PRO tab to see the full list of items
- Sort items in the order you want them to appear by clicking and dragging
- Assign a subscale name to each item and then group your items by subscale, or leave box(s) empty
- Click on ‘Generate Custom Form” and enter measure title; edit existing instruction text, if needed
PLEASE NOTE: Be sure to save form to your computer. Selected custom form items and the custom forms you generate will not be saved in your account, even if you are logged-in.
Some frequently asked questions:
How do I select items?
It is best to select items that have face validity with regard to the hypotheses or goals of your study. For example, if you are interested in pain, diarrhea, fatigue and nausea as disease- or treatment-related symptoms, select the questions in those symptom areas that best fit your patient population.
How do I score the items I selected?
Unless you use an existing, validated FACIT subscale or scale, or a set of IRT-calibrated items, do not score multi-item scales until you have conducted proper scaling analyses and validated the sum score using appropriate methods.
How do I use the items?
Use them for item-level comparisons across treatments, or within a treatment over time, to estimate emerging or dissipating symptoms or functional abilities. Consider proportion of cases responding over a certain pre-defined threshold as more easily interpreted than average scores of a group. Also consider adding in individual items to a validated questionnaire.
How do I validate the items I selected?
Validation is a process of accumulating evidence, more than an end goal. There are established methods for validating any newly-constructed scale. It is usually done by first establishing the factor structure of the item responses, and then comparing the scores on scales constructed from these factors to scores of similar questionnaires or other variables that convey similar meaning to what the summed set of questions is believe to measure (e.g., a brief fatigue scale, or a brief social function scale, etc.). The advantage of starting with the FACIT Searchable Library is the knowledge that all items were written with patient input and tested to ensure comprehension and ease of administration. Language translations were conducted with state-of-the-art methods to ensure cross-cultural relevance and semantic equivalence.
How does the FACIT translation methodology work?
All FACIT measures and items from the FACIT Measurement System follow an established FACIT Multilingual Translation Methodology,1,2 which was developed and validated to ensure that resulting translations of quantitative measures reflect conceptual equivalence with the source document rendered in language that is culturally acceptable and relevant to the target population, and is consistent with consensus opinion3. This rigorous methodology requires two forward translations into the target language by native speakers, a reconciled version of the two forward translations done by a third independent translator who is a native speaker of the target language, a back-translation of the reconciled version by an English speaker fluent in the target language, harmonization of the translation with other languages, and review/finalization by a native speaking linguist or HRQL research expert. After the translation phase is completed, items are linguistically validated by testing with patients to confirm the suitability of the translations for the target patient population.
1 Bonomi, A. E., Cella, D.F., Hahn, E.A., Bjordal, K., Sperner-Unterweger, B., Gangeri, L., Bergman, B., Willems-Groot, J., Hanquet, P., and Zittoun, R. (1996). Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual. Life. Res. 5:309-320.
2 Eremenco, S., Cella, D., & Arnold, B. J. (2005). A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation and the Health Professions, 28: 212-232.
3 Wild, D., Grove, A., Martin, M., Eremenco, S., Ford, S., Verjee-Lorenz, A. et al. (2005). Principles of good practice for the translation and cultural adaptation process for patient reported outcomes (PRO) measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation. Value in Health, 8(2): 94-104.