Evidence map›Paper›PMID 30835744›Full record

ArticlePloS one2019

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 and 8 more

Abstract read
In one paragraph

Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Charles J GerardoDivision of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America.ORCID 0000-0002-8265-1370
Joao R N VissociDivision of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America.
Leonardo P de OliveiraDuke Global Health Institute, Duke University, Durham, North Carolina, United States of America.
Victoria E AndersonCPC Clinical Research, Aurora, Colorado, United States of America.
Eugenia QuackenbushDepartment of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, United States of America.ORCID 0000-0002-9872-1396
Brandon LewisHealth Science Center, Texas A&M University, College Station, Texas, United States of America.
S Rutherfoord RoseDepartment of Emergency Medicine, Virginia Commonwealth University, Richmond, Virginia, United States of America.
Spencer GreeneDepartment of Emergency Medicine, Baylor College of Medicine, Houston, Texas, United States of America.ORCID 0000-0002-1119-5582
Eric A ToschlogDepartment of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, United States of America.
Nathan P CharltonDepartment of Emergency Medicine, University of Virginia, Charlottesville, Virginia, United States of America.
Michael E MullinsDivision of Emergency Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America.
Richard SchwartzDepartment of Emergency Medicine and Hospital Services, Medical College of Georgia, Augusta, Georgia, United States of America.
David DenningDepartment of Surgery, Marshall Health, Huntington, West Virginia, United States of America.
Kapil SharmaDepartment of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, United States of America.
Kurt KleinschmidtDepartment of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, United States of America.
Sean P BushDepartment of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, United States of America.
Nicklaus P BrandehoffDepartment of Emergency Medicine, University of California San Francisco Fresno, Fresno, California, United States of America.
Eric J LavonasRocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveValid, 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.

methodsWe 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.

resultsA 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.

conclusionsWith 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.

Indexed as

AdolescentAdultAntiveninsFemaleHumansImmunoglobulin Fab FragmentsMaleMiddle AgedMinimal Clinically Important DifferenceMulticenter Studies as TopicObservational Studies as TopicOutcome Assessment, Health CarePsychometricsQuality of LifeRandomized Controlled Trials as TopicReproducibility of ResultsAntiveninsCrotalidae Polyvalent immune FabImmunoglobulin Fab Fragments

Identifiers

PMID30835744
PMCPMC6400437

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.