The development and validation of the Family Reported Outcome Measure (FROM-16)^sup ©^ to assess the impact of disease on the partner or family member

The impact of patients' illness on family members has proven to be both widespread and severe. Currently, there is no generic instrument that can be used to measure the impact of illnesses on the partner or family members of patients. This study describes the development of the Family Reported Outcome Measure (FROM-16)^sup ©^. A total of 30 items were generated from the content of previous interviews with family members. Qualitative and quantitative feedback from expert panels was collected. Items were reduced using both Rasch analysis and factor analysis, and full psychometric testing was carried out including construct validity and reliability. Collapsing response categories, removing misfitting items and combining residually correlating items produced a good fit to the Rasch model (n = 240, total [chi] ^sup 2^ = 56.6, df = 48, p = 0.18). Factor analysis produced a 16-item measure with two factors. The FROM showed high internal consistency (n = 120, Cronbach's [alpha] = 0.80-0.89), high reproducibility (n = 51, intraclass correlation = 0.85-0.92) and a mean completion time of 2 min. Construct validity was proven through the correlation between the FROM and the WHOQOL-BREF total scores (n = 119, r = -0.53-0.52, p < 0.001), and the correlation between the FROM and the patient's overall health score (n = 120, r = -0.45-0.48, p < 0.001). The FROM-16 is both reliable and valid for use. It has a potential for wide use, including clinical (healthcare professionals or researchers in all medical specialties), industrial and social sciences. The FROM can be used to identify areas where family members need further support, as well as identify those individuals most affected by the patient's illness.[PUBLICATION ABSTRACT]