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Can Patient-Reported Outcomes Measurement Information System Capture Health-related Quality of Life among Children with Cleft Lip and Palate?
Kavitha Ranganathan, M.D., Danielle Shapiro, PhD, Noelle Carlozzi, PhD, Michaella Baker, B.S., Christian Vercler, M.D., Steven J. Kasten, M.D., Seth Warschausky, PhD, Steven R. Buchman, M.D., Jennifer F. Waljee, M.D., M.S..
University of Michigan Health Systems, Ann Arbor, MI, USA.

BACKGROUND: Accurate measures of health-related quality of life (HRQOL) among children with cleft lip and palate (CLCP) are in high demand. The NIH validated Patient-Reported Outcomes Measurement Information System (PROMIS®) could provide data to compare outcomes across conditions, but the accuracy and feasibility of these measures remain unknown.
METHODS: We surveyed children ≥ five years of age with CLCP from a multidiscplinary clinic (n=93). Children completed PROMIS® Anxiety, Depression, and Peer relationship item banks by short form (SF) or computerized adaptive testing (CAT), and the Pediatric Quality of Life Inventory (PQL) for comparison. Construct validity was measured by Spearman’s correlation coefficients. Feasibility was defined by instrument completion time and reading level. Multivariate regression analyses controlled for race, gender, age, and income.
RESULTS: PROMIS® was significantly correlated with PQL scores (PROMIS®: Peer Relationships: r=0.50, p<.001; Anxiety: r= -0.42, p<.001; Depression: r= -0.50, p<.001), with easier readability. Compared with SF versions, CAT administration demonstrated minimal floor (0% vs. 0%) and ceiling (8.6-17.5% vs. 21.8-41.9%) effects. Although CAT templates took significantly longer to complete (Anxiety: 63.4s ± 36.8 vs. 31.9s ± 13.1, p=0.002; Depression: 62.7s ± 42.8 vs. 31.7s ± 22.1, p= 0.01; Peer relationships: 75.3s ± 55.3 vs. 50.7s ± 39.1, p=0.13), children answered more questions within this time.
CONCLUSION: PROMIS® demonstrates similar accuracy, with greater sensitivity and readability compared with existing measures of HRQOL among children with CLCP. Use of such instruments will improve our ability to compare children with CLCP to diverse populations and clinical conditions in a longitudinal fashion.


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