Measuring cognitive assessment and intervention burden in patients with acquired brain injured: Development of the "How Much is Too Much" questionnaire.

OBJECTIVE: To design and preliminarily test a questionnaire intended to measure patient treatment burden resulting from participation in cognitive assessments and interventions.
METHODS: An expert consensus process was used to develop the concept of patient treatment burden and to determine the first set of questionnaire items and administration protocol. The pilot questionnaire was administered to 20 patients with mild to severe acquired brain injuries on completion of a 2-h or longer neuropsychological assessment. Following preliminary testing, the questionnaire was revised and re-evaluated by a second expert panel and content validity was assessed.
RESULTS: Burden was defined as psychologically and/or physically aversive symptoms in response to cognitive assessment or intervention. The first questionnaire contained 21 items assigned to 3 categories: physical, cognitive, and emotional. Eighty-five percent of patients endorsed symptom level increases, with "tired/fatigued" the most frequently endorsed item (80% of patients). Instructions and test items were easily understood, and the questionnaire was quick to administer. Content validity ratio (CVR) of the revised questionnaire yielded 23 acceptable items and a subset met the highest CVR threshold (>0.78).
CONCLUSION: This patient-reported outcome will ultimately help patients give voice to aversive experiences, and help clinicians and researchers to monitor and adapt assessments/treatments appropriately. Future steps in development are described.