The validity, reliability and minimal clinically important difference of the patient specific functional scale in snake envenomation

Gerardo, Charles J.; Vissoci, Joao R. N.; de Oliveira, Leonardo P.; Anderson, Victoria E.; Quackenbush, Eugenia; Lewis, Brandon; Rose, S. Rutherfoord; Greene, Spencer; Toschlog, Eric A.; Charlton, Nathan P.; Mullins, Michael E.; Schwartz, Richard; Denning, David; Sharma, Kapil; Kleinschmidt, Kurt; Bush, Sean P.; Brandehoff, Nicklaus P.; Lavonas, Eric J.

Author

Gerardo, Charles J.; Vissoci, Joao R. N.; de Oliveira, Leonardo P.; Anderson, Victoria E.; Quackenbush, Eugenia; Lewis, Brandon; Rose, S. Rutherfoord; Greene, Spencer; Toschlog, Eric A.; Charlton, Nathan P.; Mullins, Michael E.; Schwartz, Richard; Denning, David; Sharma, Kapil; Kleinschmidt, Kurt; Bush, Sean P.; Brandehoff, Nicklaus P.; Lavonas, Eric J.

Abstract

Objective: Valid, reliable, and clinically relevant outcome measures are necessary in clinical studies of snake envenomation. The aim of this study was to evaluate the psychometric (validity and reliability) and clinimetric (minimal clinically important difference [MCID]) properties of the Patient-Specific Functional Scale (PSFS) in snakebite envenomation. Methods: We performed a secondary analysis of two existing snakebite trials that measured clinical outcomes using the PSFS as well as other quality of life and functional assessments. Data were collected at 3, 7, 10, and 17 days. Reliability was determined using Cronbach’s alpha for internal consistency and the intraclass correlation coefficient (ICC) for temporal stability at 10 and 17 days. Validity was assessed using concurrent validity correlating with the other assessments. The MCID was evaluated using the following criteria: (1) the distribution of stable patients according to both standard error of measurement (SEM) and responsiveness techniques, and (2) anchor-based methods to compare between individuals and to detect discriminant ability of a positive change with a receiver operator characteristic (ROC) curve and optimal cutoff point. Results: A total of 86 patients were evaluated in this study. The average PSFS scores were 5.37 (SD 3.23), 7.95 (SD 2.22), and 9.12 (SD 1.37) at 3, 7, and 10 days, respectively. Negligible floor effect was observed (maximum of 8% at 3 days); however, a ceiling effect was observed at 17 days (25%). The PSFS showed good reliability with an internal consistency of 0.91 (Cronbach’s alpha) (95% CI 0.88, 0.95) and a temporal stability of 0.83 (ICC) (95% CI 0.72, 0.89). The PSFS showed a strong positive correlation with quality of life and functional assessments. The MCID was approximately 1.0 for all methods. Conclusions: With an MCID of approximately 1 point, the PSFS is a valid and reliable tool to assess quality of life and functionality in patients with snake envenomation.

URI

http://hdl.handle.net/10342/8346

Date

2019-03-05

Citation:

APA:

Gerardo, Charles J., & Vissoci, Joao R. N., & de Oliveira, Leonardo P., & Anderson, Victoria E., & Quackenbush, Eugenia, & Lewis, Brandon, & Rose, S. Rutherfoord, & Greene, Spencer, & Toschlog, Eric A., & Charlton, Nathan P., & Mullins, Michael E., & Schwartz, Richard, & Denning, David, & Sharma, Kapil, & Kleinschmidt, Kurt, & Bush, Sean P., & Brandehoff, Nicklaus P., & Lavonas, Eric J.. (March 2019). The validity, reliability and minimal clinically important difference of the patient specific functional scale in snake envenomation. PLOS ONE, (14:3), p.e0213077. Retrieved from http://hdl.handle.net/10342/8346

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MLA:

Gerardo, Charles J., and Vissoci, Joao R. N., and de Oliveira, Leonardo P., and Anderson, Victoria E., and Quackenbush, Eugenia, and Lewis, Brandon, and Rose, S. Rutherfoord, and Greene, Spencer, and Toschlog, Eric A., and Charlton, Nathan P., and Mullins, Michael E., and Schwartz, Richard, and Denning, David, and Sharma, Kapil, and Kleinschmidt, Kurt, and Bush, Sean P., and Brandehoff, Nicklaus P., and Lavonas, Eric J.. "The validity, reliability and minimal clinically important difference of the patient specific functional scale in snake envenomation". PLOS ONE. 14:3. (e0213077.), March 2019. September 30, 2020. http://hdl.handle.net/10342/8346.

Chicago:

Gerardo, Charles J. and Vissoci, Joao R. N. and de Oliveira, Leonardo P. and Anderson, Victoria E. and Quackenbush, Eugenia and Lewis, Brandon and Rose, S. Rutherfoord and Greene, Spencer and Toschlog, Eric A. and Charlton, Nathan P. and Mullins, Michael E. and Schwartz, Richard and Denning, David and Sharma, Kapil and Kleinschmidt, Kurt and Bush, Sean P. and Brandehoff, Nicklaus P. and Lavonas, Eric J., "The validity, reliability and minimal clinically important difference of the patient specific functional scale in snake envenomation," PLOS ONE 14, no. 3 (March 2019), http://hdl.handle.net/10342/8346 (accessed September 30, 2020).

AMA:

Gerardo, Charles J., Vissoci, Joao R. N., de Oliveira, Leonardo P., Anderson, Victoria E., Quackenbush, Eugenia, Lewis, Brandon, Rose, S. Rutherfoord, Greene, Spencer, Toschlog, Eric A., Charlton, Nathan P., Mullins, Michael E., Schwartz, Richard, Denning, David, Sharma, Kapil, Kleinschmidt, Kurt, Bush, Sean P., Brandehoff, Nicklaus P., Lavonas, Eric J.. The validity, reliability and minimal clinically important difference of the patient specific functional scale in snake envenomation. PLOS ONE. March 2019; 14(3) e0213077. http://hdl.handle.net/10342/8346. Accessed September 30, 2020.

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