Conversions from FACIT-F to PROMIS Fatigue feasible for RA clinical trials
Conversions of measurements from the Functional Assessment of Chronic Illness Therapy-Fatigue to the Patient-Reported Outcomes Measurement Information System Fatigue, or PROMIS Fatigue, is both feasible and applicable in clinical trials for RA, according to findings published in Arthritis Care & Research.
“The 13-item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) instrument was originally developed for use in cancer patients to evaluate fatigue,” Clifton O. Bingham III, MD, of Johns Hopkins University, and colleagues wrote. “FACIT-F has also been validated to assess RA-related fatigue and so has been used as an instrument in many randomized clinical trials in RA. ... The FACIT-F instrument was evaluated for its content relevance in semi-structured interviews with 17 RA patients, and 10 items were found to be most relevant to RA patients, creating a 10-item ‘optimized’ version of the instrument.”
“PROMIS was developed using item response theory and calibrated in United States general and clinical populations,” they added. “While developing items for the PROMIS Fatigue item bank, questions from existing instruments, including all 13 items from FACIT-F, were selected. PROMIS Fatigue instruments ... have been used and validated in small observational studies of RA, but there are no studies to date reporting the performance of PROMIS Fatigue in RA randomized clinical trials.”
To analyze converted PROMIS Fatigue scores’ performance, Bingham and colleagues studied data from two RA trials in which patients who received baricitinib (Olumiant, Eli Lilly): RA-BEAM and RA-BEACON. Patients in both were adults with moderate-to-severe RA.
In both studies, FACIT-F was assessed at baseline, then every 4 weeks until the end of each trial, with participants in RA-BEAM also being assessed at weeks 40 and 52. Conversions from FACIT-F to PROMIS Fatigue were calculated at the patient level using crosswalk tables and a pattern-scoring algorithm for both the 13item FACITF and the 10item RA-optimized FACITF instrument.
According to the researchers, baseline FACITF-converted PROMIS Fatigue scores demonstrated severe fatigue across treatment groups and were similar using different scoring methods. At week 24 in both RA-BEAM and RA-BEACON, treatment with baricitinib was associated with clinically meaningful improvements in PROMIS Fatigue scores. In addition, PROMIS Fatigue scores were consistent for all conversion methods and both the 13item or 10item FACIT-F.
“PROMIS provides an easy-to-interpret metric that is understandable by clinicians and patients and can be used to benchmark fatigue against general population norms,” Bingham and colleagues wrote. “Crosswalk or pattern-scoring methods of conversion facilitate the comparison of studies using FACIT-F to the PROMIS Fatigue metric allowing for the interpretation of scores against general population norms.”
“We recommend the pattern-scoring method for conversion whenever possible, particularly when there are missing responses,” they added. “Our results suggest that the measurement of fatigue using the PROMIS T-score metric can be used as an outcome demonstrating treatment benefit in RA clinical trials.” – by Jason Laday
Disclosure: Bingham reports consulting fees from AbbVie, Bristol-Myers Squibb, Eli Lilly, Genentech, Gilead, Pfizer, Regeneron and Sanofi. Please see the study for all other authors’ relevant financial disclosures.