11
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

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

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          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.

          Related collections

          Most cited references36

          • Record: found
          • Abstract: found
          • Article: not found

          Measurement of health status. Ascertaining the minimal clinically important difference.

          In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network.

            The purpose of this study was to assess the reliability, construct validity, and sensitivity to change of the Lower Extremity Functional Scale (LEFS). The LEFS was administered to 107 patients with lower-extremity musculoskeletal dysfunction referred to 12 outpatient physical therapy clinics. The LEFS was administered during the initial assessment, 24 to 48 hours following the initial assessment, and then at weekly intervals for 4 weeks. The SF-36 (acute version) was administered during the initial assessment and at weekly intervals. A type 2,1 intraclass correlation coefficient was used to estimate test-retest reliability. Pearson correlations and one-way analyses of variance were used to examine construct validity. Spearman rank-order correlation coefficients were used to examine the relationship between an independent prognostic rating of change for each patient and change in the LEFS and SF-36 scores. Test-retest reliability of the LEFS scores was excellent (R = .94 [95% lower limit confidence interval (CI) = .89]). Correlations between the LEFS and the SF-36 physical function subscale and physical component score were r=.80 (95% lower limit CI = .73) and r = .64 (95% lower limit CI = .54), respectively. There was a higher correlation between the prognostic rating of change and the LEFS than between the prognostic rating of change and the SF-36 physical function score. The potential error associated with a score on the LEFS at a given point in time is +/-5.3 scale points (90% CI), the minimal detectable change is 9 scale points (90% CI), and the minimal clinically important difference is 9 scale points (90% CI). The LEFS is reliable, and construct validity was supported by comparison with the SF-36. The sensitivity to change of the LEFS was superior to that of the SF-36 in this population. The LEFS is efficient to administer and score and is applicable for research purposes and clinical decision making for individual patients.
              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              The MOS short-form general health survey. Reliability and validity in a patient population.

                Bookmark

                Author and article information

                Contributors
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                5 March 2019
                2019
                : 14
                : 3
                : e0213077
                Affiliations
                [1 ] Division of Emergency Medicine, Duke University School of Medicine, Durham, North Carolina, United States of America
                [2 ] Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America
                [3 ] Department of Health and Biological Sciences, UniCesumar, Maringa, Paraná, Brazil
                [4 ] CPC Clinical Research, Aurora, Colorado, United States of America
                [5 ] Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado, United States of America
                [6 ] Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, United States of America
                [7 ] Health Science Center, Texas A&M University, College Station, Texas, United States of America
                [8 ] Department of Emergency Medicine, Virginia Commonwealth University, Richmond, Virginia, United States of America
                [9 ] Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, United States of America
                [10 ] Department of Surgery, East Carolina University Brody School of Medicine, Greenville, North Carolina, United States of America
                [11 ] Department of Emergency Medicine, University of Virginia, Charlottesville, Virginia, United States of America
                [12 ] Division of Emergency Medicine, Washington University School of Medicine, St. Louis, Missouri, United States of America
                [13 ] Department of Emergency Medicine and Hospital Services, Medical College of Georgia, Augusta, Georgia, United States of America
                [14 ] Department of Surgery, Marshall Health, Huntington, West Virginia, United States of America
                [15 ] Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, United States of America
                [16 ] Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, North Carolina, United States of America
                [17 ] Department of Emergency Medicine, University of California San Francisco Fresno, Fresno, California, United States of America
                [18 ] Department of Emergency Medicine, Denver Health and Hospital Authority, Denver, Colorado, United States of America
                Hong Kong Polytechnic University, HONG KONG
                Author notes

                Competing Interests: 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.

                Author information
                http://orcid.org/0000-0002-8265-1370
                http://orcid.org/0000-0002-9872-1396
                http://orcid.org/0000-0002-1119-5582
                Article
                PONE-D-18-13354
                10.1371/journal.pone.0213077
                6400437
                30835744
                c53f4656-3969-491d-bf18-7961f4bc877d
                © 2019 Gerardo et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 3 May 2018
                : 15 February 2019
                Page count
                Figures: 0, Tables: 5, Pages: 13
                Funding
                The parent studies from which data were derived, were funded by BTG International Inc. The authors received no specific funding for this work.
                Categories
                Research Article
                Medicine and Health Sciences
                Tropical Diseases
                Neglected Tropical Diseases
                Snakebite
                Biology and Life Sciences
                Organisms
                Eukaryota
                Animals
                Vertebrates
                Amniotes
                Reptiles
                Squamates
                Snakes
                Biology and Life Sciences
                Psychology
                Psychometrics
                Social Sciences
                Psychology
                Psychometrics
                Medicine and Health Sciences
                Health Care
                Quality of Life
                Research and Analysis Methods
                Research Assessment
                Research Validity
                Biology and Life Sciences
                Anatomy
                Musculoskeletal System
                Body Limbs
                Medicine and Health Sciences
                Anatomy
                Musculoskeletal System
                Body Limbs
                Biology and Life Sciences
                Toxicology
                Toxic Agents
                Toxins
                Venoms
                Medicine and Health Sciences
                Pathology and Laboratory Medicine
                Toxicology
                Toxic Agents
                Toxins
                Venoms
                Medicine and Health Sciences
                Public and Occupational Health
                Global Health
                Custom metadata
                All data used in these analysis are available as supporting information with this publication.

                Uncategorized
                Uncategorized

                Comments

                Comment on this article