PMID- 30835744 OWN - NLM STAT- MEDLINE DCOM- 20191202 LR - 20200309 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 14 IP - 3 DP - 2019 TI - The validity, reliability and minimal clinically important difference of the patient specific functional scale in snake envenomation. PG - e0213077 LID - 10.1371/journal.pone.0213077 [doi] LID - e0213077 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. FAU - Gerardo, Charles J AU - Gerardo CJ AUID- ORCID: 0000-0002-8265-1370 AD - Division of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America. AD - Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America. FAU - Vissoci, Joao R N AU - Vissoci JRN AD - Division of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America. AD - Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America. FAU - de Oliveira, Leonardo P AU - de Oliveira LP AD - Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America. AD - Department of Health and Biological Sciences, UniCesumar, Maringa, Parana, Brazil. FAU - Anderson, Victoria E AU - Anderson VE AD - CPC Clinical Research, Aurora, Colorado, United States of America. AD - Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado, United States of America. FAU - Quackenbush, Eugenia AU - Quackenbush E AUID- ORCID: 0000-0002-9872-1396 AD - Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, United States of America. FAU - Lewis, Brandon AU - Lewis B AD - Health Science Center, Texas A&M University, College Station, Texas, United States of America. FAU - Rose, S Rutherfoord AU - Rose SR AD - Department of Emergency Medicine, Virginia Commonwealth University, Richmond, Virginia, United States of America. FAU - Greene, Spencer AU - Greene S AUID- ORCID: 0000-0002-1119-5582 AD - Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, United States of America. FAU - Toschlog, Eric A AU - Toschlog EA AD - Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, United States of America. FAU - Charlton, Nathan P AU - Charlton NP AD - Department of Emergency Medicine, University of Virginia, Charlottesville, Virginia, United States of America. FAU - Mullins, Michael E AU - Mullins ME AD - Division of Emergency Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America. FAU - Schwartz, Richard AU - Schwartz R AD - Department of Emergency Medicine and Hospital Services, Medical College of Georgia, Augusta, Georgia, United States of America. FAU - Denning, David AU - Denning D AD - Department of Surgery, Marshall Health, Huntington, West Virginia, United States of America. FAU - Sharma, Kapil AU - Sharma K AD - Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, United States of America. FAU - Kleinschmidt, Kurt AU - Kleinschmidt K AD - Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, United States of America. FAU - Bush, Sean P AU - Bush SP AD - Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, United States of America. FAU - Brandehoff, Nicklaus P AU - Brandehoff NP AD - Department of Emergency Medicine, University of California San Francisco Fresno, Fresno, California, United States of America. FAU - Lavonas, Eric J AU - Lavonas EJ AD - Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado, United States of America. AD - Department of Emergency Medicine, Denver Health and Hospital Authority, Denver, Colorado, United States of America. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20190305 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Antivenins) RN - 0 (Crotalidae Polyvalent immune Fab) RN - 0 (Immunoglobulin Fab Fragments) SB - IM MH - Adolescent MH - Adult MH - Antivenins/*therapeutic use MH - Female MH - Humans MH - Immunoglobulin Fab Fragments/*therapeutic use MH - Male MH - Middle Aged MH - Minimal Clinically Important Difference MH - Multicenter Studies as Topic MH - Observational Studies as Topic MH - Outcome Assessment, Health Care MH - Psychometrics MH - Quality of Life MH - ROC Curve MH - Randomized Controlled Trials as Topic MH - Reproducibility of Results MH - Snake Bites/*drug therapy MH - Treatment Outcome MH - United States MH - Young Adult PMC - PMC6400437 COIS- Dr. Rose reports speakers bureau fees from BTG International Inc outside the submitted work. Dr. Greene reports receiving consulting fees and honoraria from BTGInternational Inc outside the submitted work. Drs. Gerardo, Charlton, Mullins, Lavonas and Kleinschmidt and Ms. Anderson report receiving prior study-related grants from BTG International Inc. The parent studies from which data were derived, were funded by BTG International Inc. This does not alter our adherence to PLOS ONE policies on sharing data and materials. EDAT- 2019/03/06 06:00 MHDA- 2019/12/04 06:00 PMCR- 2019/03/05 CRDT- 2019/03/06 06:00 PHST- 2018/05/03 00:00 [received] PHST- 2019/02/15 00:00 [accepted] PHST- 2019/03/06 06:00 [entrez] PHST- 2019/03/06 06:00 [pubmed] PHST- 2019/12/04 06:00 [medline] PHST- 2019/03/05 00:00 [pmc-release] AID - PONE-D-18-13354 [pii] AID - 10.1371/journal.pone.0213077 [doi] PST - epublish SO - PLoS One. 2019 Mar 5;14(3):e0213077. doi: 10.1371/journal.pone.0213077. eCollection 2019.