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

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

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Article numbere0213077
JournalPloS one
Volume14
Issue number3
DOIs
StatePublished - Mar 1 2019

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Snake Bites
Functional assessment
Reproducibility of Results
snakes
Ceilings
Anchors
quality of life
snake bites
Quality of Life
clinical trials
Minimal Clinically Important Difference
Aptitude
methodology
Psychometrics
Outcome Assessment (Health Care)
Clinical Trials

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

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Gerardo, C. J., Vissoci, J. R. N., De Oliveira, L. P., Anderson, V. E., Quackenbush, E., Lewis, B., ... Lavonas, E. J. (2019). The validity, reliability and minimal clinically important difference of the patient specific functional scale in snake envenomation. PloS one, 14(3), [e0213077]. https://doi.org/10.1371/journal.pone.0213077

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; Rutherfoord Rose, S.; Greene, Spencer; Toschlog, Eric A.; Charlton, Nathan P.; Mullins, Michael E.; Schwartz, Richard B; Denning, David; Sharma, Kapil; Kleinschmidt, Kurt; Bush, Sean P.; Brandehoff, Nicklaus P.; Lavonas, Eric J.

In: PloS one, Vol. 14, No. 3, e0213077, 01.03.2019.

Research output: Contribution to journalArticle

Gerardo, CJ, Vissoci, JRN, De Oliveira, LP, Anderson, VE, Quackenbush, E, Lewis, B, Rutherfoord Rose, S, Greene, S, Toschlog, EA, Charlton, NP, Mullins, ME, Schwartz, RB, Denning, D, Sharma, K, Kleinschmidt, K, Bush, SP, Brandehoff, NP & Lavonas, EJ 2019, 'The validity, reliability and minimal clinically important difference of the patient specific functional scale in snake envenomation', PloS one, vol. 14, no. 3, e0213077. https://doi.org/10.1371/journal.pone.0213077
Gerardo, Charles J. ; Vissoci, Joao R.N. ; De Oliveira, Leonardo P. ; Anderson, Victoria E. ; Quackenbush, Eugenia ; Lewis, Brandon ; Rutherfoord Rose, S. ; Greene, Spencer ; Toschlog, Eric A. ; Charlton, Nathan P. ; Mullins, Michael E. ; Schwartz, Richard B ; 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. In: PloS one. 2019 ; Vol. 14, No. 3.
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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.",
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AU - Gerardo, Charles J.

AU - Vissoci, Joao R.N.

AU - De Oliveira, Leonardo P.

AU - Anderson, Victoria E.

AU - Quackenbush, Eugenia

AU - Lewis, Brandon

AU - Rutherfoord Rose, S.

AU - Greene, Spencer

AU - Toschlog, Eric A.

AU - Charlton, Nathan P.

AU - Mullins, Michael E.

AU - Schwartz, Richard B

AU - Denning, David

AU - Sharma, Kapil

AU - Kleinschmidt, Kurt

AU - Bush, Sean P.

AU - Brandehoff, Nicklaus P.

AU - Lavonas, Eric J.

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N2 - 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.

AB - 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.

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