Final validation of the Pediatric Tracheotomy Health Status Instrument (PTHSI).

OBJECTIVE

We sought to describe the development and final testing of an instrument designed to evaluate the impact of tracheotomy on the health-related quality of life of affected families in whom a child has had a tracheotomy (the Pediatric Tracheotomy Health Status Instrument [PTHSI]).

STUDY DESIGN

This cross-sectional study designed to analyze a disease-specific health status instrument to establish validity and reliability.

RESULTS

The PTHSI was initially pilot tested in 130 families during a 3-month period from September through November 2000. After initial analysis and revision, from January 2001 through July 2001, 154 different families completed the revised instrument. The overall Cronbach's alpha coefficient for the instrument was 0.91, with domain-specific coefficients ranging from 0.66 for physical symptoms to 0.87 for caregiver stress and coping. Specific criterion validity analysis produced a Pearson correlation coefficient of 0.8 (P < 0.0001). Construct validity testing via Wilcoxon matched sum testing suggested statistically significant differences between subpopulations (P < 0.001).

CONCLUSION

After initial testing and revision of the PTHSI, final instrument administration and analysis reveal the instrument to be valid and reliable. Future studies are planned to evaluate its responsiveness in longitudinal application.