Fear Avoidance after Concussion Tool (FACT): patient-reported outcome measure development and content validation.

OBJECTIVE

No valid patient-reported outcome measures (PROMs) exist to evaluate fear avoidance behaviour following concussion. This study developed a new PROM to evaluate fear avoidance behaviour following concussion and assessed the PROM content validity.

DESIGN

PROM development was performed using a qualitative study, and content validation was performed using a mixed-methods approach.

METHODS

The development phase consisted of compiling potentially relevant items (eg, questions) from other PROMs proposed to measure fear avoidance before proceeding to a series of one-on-one semistructured interviews with patient and professional participants. The content validity (relevance, comprehensibility and comprehensiveness) of the PROM was first assessed by professional participants using an online survey, before further assessment by patient participants during one-on-one semistructured interviews.

RESULTS

For PROM development, seven patient participants (n=4 men) and seven professional participants (n=4 men) from six clinical professions were included, who generated 119 potentially relevant items under seven distinct domains. Key themes that emerged during development were a strong preference for a short PROM, with a simple scale, that has clinical utility. 38 professional participants (47% women) and seven patient participants completed the content validation. Thus, the final PROM (Fear Avoidance after Concussion Tool or FACT) has content validity, consists of 28 items, with four items per domain. The seven domains of the FACT are: general, physical, psychological, hypervigilance, cognitive, social and work.

CONCLUSION

The FACT has been developed to evaluate fear avoidance behaviour following concussion and has content validity. Future research should evaluate other measurement properties before implementation.