Abstract
Study design
It is a qualitative study.
Objectives
To develop the items and support content validity for the Pediatric Quality of Life Inventory™ (PedsQL™) Spinal Cord Injury Module for youth and emerging adults with spinal cord injury (SCI).
Setting
Community and children’s hospital.
Methods
A comprehensive literature review was conducted in pediatric and SCI-specific health-related quality-of-life (HRQoL) measures to create an item bank. A multidisciplinary panel of experts convened to discuss the conceptual framework of the module, reviewed the item bank, and generated a core set of items through a process of “binning-and-winnowing”. International clinicians and researchers participated in iterative rounds of a Modified Delphi survey, until 90% agreement was reached on all items of the core set, resulting in the construction of a preliminary module. Cognitive interviews were conducted on individuals with SCI and their parents to determine the relevance of items and age-appropriate wording of the preliminary module. The research team regularly reviewed transcriptions of the interviews, and incorporated participant feedback to modify the modules. This process was repeated until content saturation was achieved.
Results
A total of 43 participants completed the cognitive interviews. Following five iterations of cognitive interviews and modifications based on participant input, the PedsQL™ SCI Module was generated. It comprised 67 items in the 12 domains of Daily Activities, Mobility, Bladder Function, Bowel Function, Muscle Spasms, Pressure Injury, Pain, Orthostatic Hypotension, Autonomic Dysreflexia, Participation, Worry, and Emotions.
Conclusions
The PedsQL™ SCI Module was developed using well-established qualitative methods. Internet-based field testing is underway to finalize its development and validation.
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Data availability
Data sharing is not applicable to this paper as no datasets were generated or analyzed during this study.
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Acknowledgements
The authors would like to thank Jessica Cwik, BS, for her role in conducting the cognitive interviews, and David Chlan, BA, for his expertise in designing the online platforms used in the modified Delphi surveys and field testing.
Funding
This study was funded by the Craig H. Neilsen Foundation Psychosocial Research Grant # 542021.
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Authors and Affiliations
Contributions
MH substantially contributed to the study design, acquisition, and analysis of cognitive interviews and drafting of the paper. KZ contributed to study conception and design, analysis of interviews, and drafting of the paper. LCV substantially contributed to study conception and design, analysis of interviews, drafting the paper, and acquisition of funding. MJM contributed to the study conception and design, and drafting of the paper. JWV contributed to the study conception and design, analysis of interviews, and review of the paper for critical intellectual content. All authors read and approved the final paper.
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Conflict of interest
JWV holds the copyright and trademark for the PedsQL™ and receives financial compensation from the Mapi Research Trust, which is a nonprofit research institute that charges distribution fees to for-profit companies that use the Pediatric Quality of Life Inventory™.
Ethics
This study was reviewed and approved by the Western Institutional Review Board (Study Number 1248478). We certify that all applicable institutional regulations concerning the ethical use of human volunteers were followed during the course of this research.
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Hwang, M., Zebracki, K., Vogel, L.C. et al. Development of the Pediatric Quality of Life Inventory™ Spinal Cord Injury (PedsQL™ SCI) module: qualitative methods. Spinal Cord 58, 1134–1142 (2020). https://doi.org/10.1038/s41393-020-0450-6
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DOI: https://doi.org/10.1038/s41393-020-0450-6
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