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Outcome measures for clinical trials in pediatric eye care and strabismus
Investigator (PI): Holmes, Jonathan M
Performing Organization (PO): (Current): Mayo Clinic, Department of Ophthalmology / (507) 284-2511
Supporting Agency (SA): National Institutes of Health (NIH), National Eye Institute (NEI)
Initial Year: 2014
Final Year: 2019
Record Source/Award ID: RePorter/R01EY024333
Funding: 2014 Award Amount: $667,053
2015 Award Amount: $636,245
2016 Award Amount: $668,466
Award Type: Grant
Abstract: 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; and 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.
MeSH Terms:
  • Calibration
  • Clinical Trials as Topic
  • Eye Diseases /*therapy
  • Humans
  • Outcome Assessment, Health Care
  • Patient-Centered Care
  • Pediatrics /*methods
  • Program Evaluation
  • Quality of Health Care
  • Quality of Life
  • Reproducibility of Results
  • Strabismus /*therapy
Keywords:
  • amblyopia
  • calibration
  • child
  • childhood
  • device or instrument development
  • esotropia
  • eye
  • eye diseases
  • health-related quality of life
  • instrument
  • interview
  • methods
  • outcome measure
  • parents
  • patient outcomes assessments
  • patients
  • quality of care
  • strabismus
  • treatment effectiveness
  • visual impairment
Country: United States
State: Minnesota
Zip Code: 55905
UI: 20161273
Project Status: Completed