OBJECTIVES: To develop and test a patient-reported outcome measure (PROM) of Life-Sustaining Medical-Technology for children and youth, which can be used in labelling claims.

METHODS: In Phase I, (item-generation), measurement content was derived from caregiver interviews. Each item was then scored out of 10 for i) importance, ii) clarity/comprehension, and iii) ethics, by a caregiver panel. Phase II, (quantitative field-testing), was conducted on a new clinical and online community-dwelling convenience sample of carers, whose children were 18-months to 25 years.

RESULTS: Phase I, (n=32), caregiver X̄=39.5, (range 28-47), of children receiving: G-tube (n=25), pump (n=12), GJ-tube (n=5), J-tube (n=1), NG-tube (n=1), suction (n=15), oxygen (n=8), oximetre (n=6), cough assist (n=6), nebulizer (n=6), ventilator (n=3). Ten domain scales assessed the impact of medical technology on all aspects of child and caregiver mental and physical health using 167 items. Item-reduction was performed using cognitive interviews, factor analysis and Guttman scaling.

Phase II (n=72) caregivers of children using 1-5 medical technology devices for enteral nutrition (n=69) or respiratory (n=12) completed the PROM. Cronbach’s α=0.76-0.89, inter-item correlations=0.32-0.87, and factor loadings=0.62-0.93 for the long-form. Following item-reduction, 30 candidate items were retained for future validation of a short-form.

CONCLUSIONS: PROM scales of Life-Sustaining Medical-Technology demonstrate adequate psychometrics for research use in the multi-scale long form. Further validation with the reduced items, on a larger sample, will allow for item-response theory testing. This approach will generate shorter scales for use in comparative-effectiveness and regulatory claims.