Cheryl Vigen PhD
Research Assistant Professor
Room: CHP 101J
Phone: (323) 442-2749
Cheryl Vigen has served as a teaching and research assistant at the Keck School of Medicine of USC, and currently teaches biostatistics in the Department of Preventive Medicine. Dr. Vigen has been a research investigator on projects in such diverse areas as atherosclerosis, HIV, hematology, Alzheimer's Disease, cancer and ophthalmology. Within the Division, Dr. Vigen is currently working on the Pressure Ulcer Prevention in SCI (PUPS) research study and the USC Well Elderly Study, and is available to consult with other researchers regarding study design, data management and statistical analysis.
Doctor of Philosophy (PhD) in Epidemiology
University of Southern California
Master of Science (MS) in Biostatistics
University of Southern California
Master of Science (MS) in Mathematics
University Illinois at Chicago
Bachelor of Arts (BA) in Mathematics
University of California, San Diego
Clark, F., Pyatak, E. A., Carlson, M., Blanche, E. I., Vigen, C., Hay, J., Mallinson, T., Blanchard, J., Unger, J. B., Garber, S. L., Diaz, J., Florindez, L. I., Atkins, M., Rubayi, S., & Azen, S. P. (2014). Implementing trials of complex interventions in community settings: The USC-Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS). Clinical Trials, 11, 218-229. doi:10.1177/1740774514521904. Link to full text
BACKGROUND: Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects.
PURPOSE: We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury.
METHODS: Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes.
RESULTS: PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination.
LIMITATIONS: We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings.
CONCLUSIONS: Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.
McDonald, A. E., & Vigen, C. (2012). Reliability and validity of the McDonald Play Inventory. American Journal of Occupational Therapy, 66, e52-e60. doi:10.5014/ajot.2012.002493. Link to full text
OBJECTIVE: This study examined the ability of a two-part self-report instrument, the McDonald Play Inventory, to reliably and validly measure the play activities and play styles of 7- to 11-yr-old children and to discriminate between the play of neurotypical children and children with known learning and developmental disabilities.
METHOD: A total of 124 children ages 7–11 recruited from a sample of convenience and a subsample of 17 parents participated in this study.
RESULTS: Reliability estimates yielded moderate correlations for internal consistency, total test intercorrelations, and test–retest reliability. Validity estimates were established for content and construct validity.
CONCLUSION: The results suggest that a self-report instrument yields reliable and valid measures of a child’s perceived play performance and discriminates between the play of children with and without disabilities.