Outcome Measures for Clinical Trials in Pediatric Eye Care and Strabismus

Project: Research project

Project Details

Description

DESCRIPTION (provided by applicant): For future clinical trials and epidemiological studies in pediatric eye disease there is a critical need for comprehensive patient-reported outcome measures (PROMs) that include both child and parent perspectives. PROMs provide a very important means of assessing treatment benefit in clinical trials and observational studies. PROMs also provide a means to assess quality outcomes and effectiveness of health care from the patient's perspective. One component of PROMs is assessment of health-related quality of life (HRQOL). Existing HRQOL instruments for pediatric eye disease are either: not patient derived, or are single-condition specific, or specific to visual impairment, or do not apply item response theory (such as Rasch analysis). In this proposal we plan to: 1) develop an HRQOL item bank for children and their parents covering the spectrum of pediatric eye disease, by conducting individual interviews with children and parents and collating items from existing instruments 2) calibrate the items using Rasch analysis 3) evaluate validity of the new Rasch-based domain short forms including comparison to the existing generic PedsQL and assessment of construct validity, test-retest reliability and responsiveness. We envision that the new Rasch-based short forms created for each domain (for child, proxy and parent) will be implemented across clinical research in pediatric eye disease, and the Rasch calibrated items will be used in future computerized adaptive testing.
StatusFinished
Effective start/end date5/1/144/30/19

Funding

  • National Institutes of Health: $667,053.00
  • National Institutes of Health: $636,245.00
  • National Institutes of Health: $668,466.00

ASJC

  • Medicine(all)

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