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. 2022 Jun 8;11:628. [Version 1] doi: 10.12688/f1000research.122116.1

Table 2. List of unique outcomes identified in systematic review and summary information.

Outcome area Outcome summary
Mortality Death was measured as all-cause mortality, survival, or cause-specific mortality
Life Impact Outcome
  • 1.
    Functional life impact: Patient Specific Functional Scale, and the physical function domain of the SF-36 questionnaire
  • 2.
    Disability: Sheehan Disability Inventory and American Medical Association (AMA) disability rating score.
  • 3.
    Quality of life: Patient's Global Impression of Change Scale, Clinical Global Impression - Improvement (CGI-I), and Patient-reported outcome measurement information system physical function-10 score (PROMIS PF-10).
  • 4.
    Time to functional recovery: defined as time to full functional status recovery as measured by the Patient-Specific Functional Scale, or complete resolution of swelling and ability to run and jump (for lower extremity bites) or equal hand-grip (for upper extremity bites).
  • 5.
    Lower extremity function: Scores on Lower Extremity Functional Scale, and walking speed.
  • 6.
    Upper extremity function: Scores on the Disorders of the Arm, Shoulder, and Hand (DASH) and grip strength through a dynamometer.
Resource use outcome Hospital
  • 1.
    Duration of hospital stay: no clear criterion for discharge except in one study.
  • 2.
    Duration of Intensive Care Unit (ICU) stay: no clear criterion.
Need for further intervention
  • 1.
    Requirement of a blood product (unspecified or any).
  • 2.
    Requirement of FFP (fresh frozen plasma).
  • 3.
    Requirement of PRBC (packed red blood cell).
  • 4.
    Requirement of platelets.
  • 5.
    Requirement of cryoprecipitate.
  • 6.
    Requirement of mechanical ventilation.
  • 7.
    Requirement for non-invasive ventilation or reintubation (Post- extubation).
  • 8.
    Requirement of antibiotic.
  • 9.
    Requirement of analgesic.
  • 10.
    Requirement of dialysis/renal replacement therapy.
  • 11.
    Requirement of antivenom.
Economic
  • 1.
    Cost of antivenom (average compared).
  • 2.
    Any cost-related outcome.
Adverse event/effect
  • 1.
    Adverse event unclassified: proportion and time from antivenom infusion to reaction with or without classification of severity or frequency/proportion of treatment emergent adverse event.
  • 2.
    Anaphylaxis: incidence and time from antivenom infusion to anaphylaxis with or without classification (Brown 2004 criterion) of severity.
  • 3.
    Anaphylactoid syndrome: incidence of anaphylactoid syndrome, pyrogenic reaction alone and urticaria alone.
  • 4.
    Early antivenom reaction (EAR): incidence and time from antivenom infusion to EAR.
  • 5.
    Late antivenom reaction: incidence.
  • 6.
    Adverse events specific to FFP: incidence.
  • 7.
    Capillary leak syndrome: incidence.
Physiological/Clinical Eye
  • 1.
    Conjunctival oedema.
Cardiac
  • 1.
    Cardiac rhythm abnormalities.
  • 2.
    Hypotension.
  • 3.
    Shock.
Psychiatric
  • 1.
    Anxiety: Hopkins somatic symptoms checklist.
  • 2.
    Depression: modified Sinhala version of the Beck depression inventory.
  • 3.
    Post-Traumatic Stress Disorder: Post-traumatic Stress Symptom Scale-Self Report Scale.
  • 4.
    Suicidal ideation and behaviour: Columbia-Suicide Severity Rating.
Respiratory, thoracic and mediastinal
  • 1.
    Respiratory distress: measured as airway obstruction, respiratory failure, and acute respiratory distress syndrome; no specific definition reported.
  • 2.
    Negative inspiratory pressure: standard methods.
  • 3.
    Forced vital capacity: standard methods.
Neurological
  • 1.
    Paralysis: proportion or duration; assessed clinically, no clear definition.
  • 2.
    Ophthalmoplegia/Ptosis: days for resolution of ptosis/ophthalmoplegia, endurance of upward gaze, and proportion of the iris uncovered.
  • 3.
    Anosmia: as reported by patient.
  • 4.
    Motor strength: no clear definition.
  • 5.
    Neurotoxicity overall: incidence/frequency and time to complete resolution of all neuroparalytic features.
Injury/Poisoning
  • 1.
    Venom concentration: standard methods.
  • 2.
    Anti-venom concentration: standard methods.
  • 3.
    Varisyllabic-methyl levels: standard methods.
Immunological
  • 1.
    Immunogenicity profile: standard methods.
  • 2.
    profile of antibodies: standard methods.
  • 3.
    COVIP-Plus induced sera: standard methods.
General
  • 1.
    Pain: intensity measured by Visual Analogue Scale, time for complete resolution of the local pain with or without induration.
  • 2.
    Non-specific systemic symptoms: no definition provided.
Musculoskeletal
  • 1.
    Myotoxicity as an outcome was measured clinically, levels of creatine kinase, and levels of lactate dehydrogenase, creatine phosphokinase, metalloproteinases.
Skin and subcutaneous
  • 1.
    Necrosis: assessed clinically, no clear definition.
  • 2.
    Blistering: assessed clinically, no clear definition.
  • 3.
    Oedema: measured as circumference difference between the affected limb and the normal limb; circumference measurements of the affected limb alone; remission time of limb swelling; cessation of local swelling progression; time to swelling resolution; oedema progression; measurement of decrease of oedema-scaled dish.
  • 4.
    Swelling: measured based on the number of segments affected (extent) and increase in circumference of the bitten limb (intensity); proximal length of swelling from bite site; criteria developed by Warell et al 1977; criteria based on physical appearance of swelling; swelling is confirmed to bitten segment or crosses 1 or 2 joints; and % increase in volume compared to contralateral (non-envenomated) limb.
  • 5.
    Wound cosmesis: measured by any validated cosmesis score.
  • 6.
    Any other wound related outcome, including but not limited to cosmesis.
Infection, Infestation, and Inflammation
  • 1.
    Abscess.
  • 2.
    Blister.
  • 3.
    Cellulitis.
  • 4.
    Inflammatory markers.
  • 5.
    Pneumonia.
  • 6.
    Ventilator associated pneumonia.
  • 7.
    Wound infection.
Kidney and Urinary Outcomes
  • 1.
    Blood urea nitrogen (BUN) and creatinine levels measures in serum.
  • 2.
    Acute Kidney Injury defined as per Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE) Criteria, Kidney Disease Improving Global Outcomes (KDIGO) Criteria, measurement of surrogate markers (Neutrophil gelatinase-associated lipocalin, beta2-microglobulin, Kidney Injury Molecule-1, serum creatinine), estimated glomerular filtration rate and oliguria.
  • 3.
    Abnormalities in urine: proteinuria or haematuria.
  • 4.
    Chronic kidney disease: no definition provided.
  • 5.
    Renal angle tenderness: no definition provided.
  • 6.
    Ferryl-haem derivatives: detected in urine sample.
Blood and lymphatic system
  • 1.
    Blood coagulability -by 20 min whole blood clotting test (WBCT20)/Lee -White method, or standard laboratory measures of international normalized ratio (INR), bleeding time (BT), clotting time (CT), Prothrombin Time (PT), aPTT (activated partial thromboplastin time).
  • 2.
    Platelet count- standard laboratory measures.
  • 3.
    Clotting Factors- Clotting factor panel or specific factors like fibrinogen, Factor V, VII, VIII, Fibrinogen degradation products/D-dimer.
  • 4.
    Bleeding – defined clinically using various criterion.
  • 5.
    Clot Quality- measures as per a method developed by Reid
  • 6.
    Other Haematological parameters – complete blood count, packed cell volume.
  • 7.
    Lymphadenopathy/lymphadenitis – no clear clinical criteria provided.
Composite Outcome
  • 1.
    Clinical recovery as a composite outcome: seven unique definitions were used.
  • 2.
    Complications as a composite outcome: four different definitions were used or not clearly reported.
  • 3.
    Envenoming manifestations: measured compositely as improvement in signs and symptoms of envenoming (systematic alone or together with local).
  • 4.
    Snakebite Severity Score (SSS): either the complete SSS or the pulmonary, cardiovascular, hematologic symptoms, and nervous system sub scores of the SSS, and as defined in the US FDA-approved information for Crotaline Polyvalent Immune Fab antivenom (FabAV) prescription.
  • 5.
    Haemolysis: measured using haemolysis markers (visual haemolysis score level and abnormal lactate dehydrogenase - LDH levels).
  • 6.
    Local Inflammation: Reduction in local inflammatory manifestations such as pain, oedema, and temperature (flushing).
  • 7.
    Prognosis: no clear definition.
  • 8.
    Treatment failure: measured as a composite outcome based on clinical features.