OF THE FACIT MEASURES
For all FACIT measures, higher scores are better than lower scores. This is true whether measuring a symptom or a functional ability. All FACIT measures use raw total scoring approach without subsequent transformation. Scoring recommendations permit for a variety of component and composite calculations, depending on the desired outcome assessment, meeting FDA guidance recommendations for both global and targeted symptom evaluation.
For any FACIT measure, subscale scores are calculated by first reversing negatively stated-items (subtracting the response from ‘4’) and then summing the raw (0-4) scores. A total score is then derived by summing subscale scores. For example, a total FACT-G score is obtained by summing individual subscale scores PWB + EWB + SWB + FWB. Total scores for the disease-, treatment-, and condition-specific subscales are typically obtained by summing all subscale scores PWB + EWB + SWB + FWB + additional concerns subscale. The scoring templates provided for each measure simplify this process by providing a framework to reverse score relevant items and prorate for missing data.
The TOI can be computed for any FACIT disease-, treatment-, or condition-specific scale. It is the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and additional concerns subscales. Our experience with this TOI endpoint is that it is an efficient summary index of physical/functional outcomes. It is therefore a common endpoint used in clinical trials, because it is responsive to change in physical/functional outcomes, sometimes more than a total (overall) multidimensional aggregated score, which includes social and emotional well-being. While social and emotional well-being are very important to quality of life, they are not as likely to change as quickly or dramatically over time or in response to physical health interventions such as pharmaceutical treatments in clinical trials.
Relevant scoring options are outlined on each measure’s scoring template, where calculating reverse scored items and prorating for missing data has been integrated. In cases where individual items are skipped, subscale scores can be prorated using the average of the other answers in the scale. This is acceptable as long as more than 50% of the items were answered in the subscale (e.g., a minimum of 4 of 7 items, 4 of 6 items, etc.). The total score is then calculated as the sum of the un-weighted subscale scores. A FACIT measure is considered to be an acceptable indicator of patient quality of life as long as overall item response rate is greater than 80% (e.g., at least 22 of 27 FACT-G items completed). This is not to be confused with individual subscale item response rate, which allows a subscale score to be prorated for missing items if greater than 50% of items are answered. In addition, a total score should only be calculated if ALL of the component subscales have valid scores.
Scoring is intended to be completed by research and clinical staff rather than patients themselves. Raw scoring templates are available in English and electronic scoring options are currently not available from FACIT.