OF THE FACIT MEASURES
Ideally, FACIT measures are self-administered. The original FACIT measure administration was via paper format, and most of the early measures were validated in the context of self-report via paper forms. Interviewer administration (in-person and by telephone) has also been used with success when conducted by someone trained in non-biasing interview techniques. More recently, advances in technology have enabled electronic methods for PRO administration, including by telephone using interactive voice response (IVR), and via touchscreen, computer tablet and smartphones using web-based platforms that enable electronic data collection and storage. Research comparing mode of administration for health outcome measures (paper and pencil vs computer-based assessments), including FACIT measures, has demonstrated a high degree of equivalence across a variety of patient populations and clinical settings.
Interview administration is appropriate with adequate training of interviewers to minimize bias to patient responses. Across these modes of administration, our data suggest that these alternate formats are essentially equivalent.
For self-administration, patients should be instructed to read the brief directions at the top of the page. After the patient's correct understanding has been confirmed, he/she should be encouraged to complete every item in order without skipping any. Some patients may feel that a given question is not applicable to them and will therefore skip the item altogether. However, patients should be encouraged to circle the response that is most applicable. If, for example, a patient is not currently receiving any treatment, the patient should circle “not at all” to the question “I am bothered by side effects of treatment.”
Respondent burden is typically minimal given that the questionnaires are written at the 4th grade reading level and are specifically formatted for ease of self-administration. Average time to completion is 5-10 minutes, and even less for some stand-alone scales and symptom indices. The option to complete the questionnaire by interview also decreases burden for patients whose condition (e.g. fatigue; poor eyesight) or mood preclude them from completing the questionnaire by self-administration. We recommend that patients who complete the questionnaire by interview (in person and over the telephone) have a copy of the questionnaire or the response scale as a reference. This can help facilitate response selection in patients who have difficulty recalling the rating scale, and reduce the amount of time needed to repeat rating scale options for each individual item.
We encourage the following sequence of modes, in order:
Self-administration without assistance
Self-administration with assistance from an objective person (i.e., not a friend or family member, but a staff person)
Self-administration with assistance from a familiar person
Proxy report from a familiar person
Skipping items versus making them mandatory
This is more of an ethical and practical issue than it is a measurement one. Ethically, patients have a right to refuse any aspect of trial participation, from taking the medicine to going to the laboratory and completing assessments. Therefore, we allow patients to decline any given question, because doing so encourages them to complete the measure rather than quit and refuse to continue.
Electronic administration of the FACIT measures occurs regularly and no further usability or validity testing should be necessary. However, FACIT does not provide the electronic platform for administration and scoring of our measures. A guidance for electronic presentation of FACIT items can be found here.