Prospective study of recovery from copperhead snake envenomation: an observational study

Eric J Lavonas, Charles J Gerardo, Copperhead Snakebite Recovery Outcome Group, Karen Arcuri, Claire A Daugherty, Anna Temu, Victoria E Anderson, Becki Bucher Bartelson, Michael S Coulter, Stephanie M Gillman, Erin M Goodman, Vaishali Khatri, Eric J Lavonas, Jason E Lones, Elizabeth A Spradley, Jun Sun, Charles J Gerardo, Weiying G Drake, Thomas C Arnold, Kimberley Hutchinson, Brandon J Lewis, Debbie Lewis, Tina C Amlin, David L Morgan, Cathy Dykes, William R Witham, Rebecca C Bowers, Joann Short, Robert D Cox, Lea H Becker, Nathan P Charlton, Eric A Toschlog, Frank R Watkins, S Rutherfoord Rose, Michael E Mullins, Eric J Lavonas, Charles J Gerardo, Copperhead Snakebite Recovery Outcome Group, Karen Arcuri, Claire A Daugherty, Anna Temu, Victoria E Anderson, Becki Bucher Bartelson, Michael S Coulter, Stephanie M Gillman, Erin M Goodman, Vaishali Khatri, Eric J Lavonas, Jason E Lones, Elizabeth A Spradley, Jun Sun, Charles J Gerardo, Weiying G Drake, Thomas C Arnold, Kimberley Hutchinson, Brandon J Lewis, Debbie Lewis, Tina C Amlin, David L Morgan, Cathy Dykes, William R Witham, Rebecca C Bowers, Joann Short, Robert D Cox, Lea H Becker, Nathan P Charlton, Eric A Toschlog, Frank R Watkins, S Rutherfoord Rose, Michael E Mullins

Abstract

Background: Although much is known about signs, symptoms, and management in the acute phase of crotaline snake envenomation, little is known about signs, symptoms, function, and quality of life during the recovery phase. The purpose of this observational pilot investigation is to evaluate the utility of several clinical outcome instruments in the setting of copperhead snakebite, and to characterize the clinical course of recovery.

Methods: This is a multi-center prospective, open-label, observational study of patients envenomated by copperhead snakes. We administered the Disabilities of the Arm, Shoulder, and Hand (DASH), Lower Extremity Functional Scale (LEFS), Patient-Specific Functional Scale (PSFS), Work Productivity and Ability Impairment: Special Health Problem (WPAI: SHP), Patients' Global Impression of Change (PGIC), Patient's Global Assessment of Recovery (PGAR), and SF-36 instruments, obtained numeric pain rating scales, and measured grip strength, walking speed, and swelling prior to hospital discharge and 3, 7, 14, 21, and 28 days after envenomation.

Results: 20 subjects were enrolled; none were lost to follow-up. Most (80%) had moderate severity swelling, and most (75%) received antivenom. Across the broad range of measures, abnormalities of pain, swelling, impairments of physical and role function, and quality of life persisted for 7-14 days in most subjects. Validated self-reported outcome measures, such as the DASH, LEFS, PSFS, PGIC, SF-36, and the daily activities impairment portion of the WPAI: SHP were more responsive than measurements of swelling or walking speed. Data quality issues limited the utility of the work impairment portion of the WPAI: SHP. Residual signs, symptoms, and impairment in some subjects lasted through the 28-day study period. The study design precluded any assessment of the effectiveness of antivenom.

Conclusions: Signs, symptoms, impaired function, and decreased quality of life typically last 7 - 14 days after copperhead envenomation. Several tools appear responsive and useful in studying recovery from pit viper envenomation.

Trial registration: ClinicalTrials.gov NCT01651299.

Figures

Figure 1
Figure 1
Participant Flow.
Figure 2
Figure 2
Analgesic Use: Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 15; No FabAV n = 5. B: Subgroup size: Mild n = 1, Moderate n = 16, Severe n = 3. C: Subgroup size: Upper extremity (UE) n = 10, Lower extremity (LE) n = 10.
Figure 3
Figure 3
Patient Global Assessment of Recovery (PGAR): Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 15; No FabAV n = 5. B: Subgroup size: Mild n = 1, Moderate n = 16, Severe n = 3. C: Subgroup size: Upper extremity n = 10, Lower extremity n = 10.
Figure 4
Figure 4
Numeric Pain Rating Scale (NPRS): Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 15; No FabAV n = 5. B: Subgroup size: Mild n = 1, Moderate n = 16, Severe n = 3. C: Subgroup size: Upper extremity n = 10, Lower extremity n = 10.
Figure 5
Figure 5
Numeric Swelling Scale (NSS): Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 15; No FabAV n = 5. B: Subgroup size: Mild n = 1, Moderate n = 16, Severe n = 3. C: Subgroup size: Upper extremity n = 10, Lower extremity n = 10.
Figure 6
Figure 6
Return to Work, School, or Usual Activities of Daily Living (ADLs): Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 15; No FabAV n = 5. B: Subgroup size: Mild n = 1, Moderate n = 16, Severe n = 3. C: Subgroup size: Upper extremity n = 10, Lower extremity n = 10.
Figure 7
Figure 7
Patient’s Global Impression of Change (PGIC): Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 15; No FabAV n = 5. Missing data from one FabAV subject on Day 3 and one No FabAV subject on Day 14. B: Subgroup size: Mild n = 1, Moderate n = 16, Severe n = 3. Missing data from 1 Severe subject on Day 3 and one Moderate subject on Day 14. C: Subgroup size: Upper extremity n = 10, Lower extremity n = 10. Missing data from one Lower Extremity subject on Day 3 and one Upper Extremity subject on Day 14.
Figure 8
Figure 8
Disabilities of the Arm, Shoulder, and Hand (DASH) Scores: Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 6; No FabAV n = 4. B: Subgroup size: Mild n = 1; Moderate n = 8; Severe n = 1.
Figure 9
Figure 9
Lower Extremity Functional Scale (LEFS) Scores: Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 9; No FabAV n = 1. Missing data from one FabAV subject on Day 21. B: Subgroup size: Mild n = 0, Moderate n = 8, Severe n = 2. Missing data from one Severe subject on Day 21.
Figure 10
Figure 10
Patient-Specific Functional Scale (PSFS): Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 15; No FabAV n = 5. B: Subgroup size: Mild n = 1, Moderate n = 16, Severe n = 3. C: Subgroup size: Upper extremity n = 10, Lower extremity n = 10.
Figure 11
Figure 11
Quality of Life, 36-item Short Form Health Survey (SF-36®, v2 Acute version) Physical Component Scale and Mental Component Scale Scores: Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 15; No FabAV n = 5. B: Subgroup size: Mild n = 1, Moderate n = 16, Severe n = 3. C: Subgroup size: Upper extremity n = 10, Lower extremity n = 10. D: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 15; No FabAV n = 5. E: Subgroup size: Mild n = 1, Moderate n = 16, Severe n = 3. F: Subgroup size: Upper extremity n = 10, Lower extremity n = 10.
Figure 12
Figure 12
Daily Activities Impairment: Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 15; No FabAV n = 5. B: Subgroup size: Mild n = 1, Moderate n = 16, Severe n = 3. C: Subgroup size: Upper extremity n = 10, Lower extremity n = 10.
Figure 13
Figure 13
Figure-of-Eight Swelling Measurements: Subgroup Results. A: Upper Extremity. FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 6; No FabAV n = 4. Missing data from one FabAV subject on Days 7 and 14. B: Lower Extremity. FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 9; No FabAV n = 1. Missing data from one FabAV subject on Day 3.
Figure 14
Figure 14
Grip Strength: Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 6; No FabAV n = 4. Missing data from one FabAV subject on Days 7 and 14. B: Subgroup size: Mild n = 1; Moderate n = 8; Severe n = 1. Missing data from the Severe subject on Days 7 and 14.
Figure 15
Figure 15
Walking Speed: Subgroup Results. A: FabAV: Crotaline Polyvalent Immune Fab (ovine). Subgroup size: FabAV n = 9; No FabAV n = 1. B: Subgroup size: Mild n = 0, Moderate n = 8, Severe n = 2.

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