Mortality
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Death was measured as all-cause mortality, survival, or cause-specific mortality |
Life Impact Outcome
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1.
Functional life impact: Patient Specific Functional Scale, and the physical function domain of the SF-36 questionnaire
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2.
Disability: Sheehan Disability Inventory and American Medical Association (AMA) disability rating score.
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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).
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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).
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5.
Lower extremity function: Scores on Lower Extremity Functional Scale, and walking speed.
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6.
Upper extremity function: Scores on the Disorders of the Arm, Shoulder, and Hand (DASH) and grip strength through a dynamometer.
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Resource use outcome
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Hospital
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Need for further intervention
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1.
Requirement of a blood product (unspecified or any).
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2.
Requirement of FFP (fresh frozen plasma).
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3.
Requirement of PRBC (packed red blood cell).
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4.
Requirement of platelets.
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5.
Requirement of cryoprecipitate.
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6.
Requirement of mechanical ventilation.
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7.
Requirement for non-invasive ventilation or reintubation (Post- extubation).
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8.
Requirement of antibiotic.
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9.
Requirement of analgesic.
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10.
Requirement of dialysis/renal replacement therapy.
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11.
Requirement of antivenom.
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Economic
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Adverse event/effect
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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.
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2.
Anaphylaxis: incidence and time from antivenom infusion to anaphylaxis with or without classification (Brown 2004 criterion) of severity.
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3.
Anaphylactoid syndrome: incidence of anaphylactoid syndrome, pyrogenic reaction alone and urticaria alone.
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4.
Early antivenom reaction (EAR): incidence and time from antivenom infusion to EAR.
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5.
Late antivenom reaction: incidence.
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6.
Adverse events specific to FFP: incidence.
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7.
Capillary leak syndrome: incidence.
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Physiological/Clinical
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Eye
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Cardiac
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Psychiatric
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1.
Anxiety: Hopkins somatic symptoms checklist.
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2.
Depression: modified Sinhala version of the Beck depression inventory.
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3.
Post-Traumatic Stress Disorder: Post-traumatic Stress Symptom Scale-Self Report Scale.
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4.
Suicidal ideation and behaviour: Columbia-Suicide Severity Rating.
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Respiratory, thoracic and mediastinal
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1.
Respiratory distress: measured as airway obstruction, respiratory failure, and acute respiratory distress syndrome; no specific definition reported.
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2.
Negative inspiratory pressure: standard methods.
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3.
Forced vital capacity: standard methods.
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Neurological
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1.
Paralysis: proportion or duration; assessed clinically, no clear definition.
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2.
Ophthalmoplegia/Ptosis: days for resolution of ptosis/ophthalmoplegia, endurance of upward gaze, and proportion of the iris uncovered.
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3.
Anosmia: as reported by patient.
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4.
Motor strength: no clear definition.
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5.
Neurotoxicity overall: incidence/frequency and time to complete resolution of all neuroparalytic features.
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Injury/Poisoning
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1.
Venom concentration: standard methods.
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2.
Anti-venom concentration: standard methods.
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3.
Varisyllabic-methyl levels: standard methods.
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Immunological
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1.
Immunogenicity profile: standard methods.
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2.
profile of antibodies: standard methods.
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3.
COVIP-Plus induced sera: standard methods.
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General
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1.
Pain: intensity measured by Visual Analogue Scale, time for complete resolution of the local pain with or without induration.
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2.
Non-specific systemic symptoms: no definition provided.
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Musculoskeletal
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1.
Myotoxicity as an outcome was measured clinically, levels of creatine kinase, and levels of lactate dehydrogenase, creatine phosphokinase, metalloproteinases.
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Skin and subcutaneous
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1.
Necrosis: assessed clinically, no clear definition.
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2.
Blistering: assessed clinically, no clear definition.
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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.
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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.
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5.
Wound cosmesis: measured by any validated cosmesis score.
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6.
Any other wound related outcome, including but not limited to cosmesis.
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Infection, Infestation, and Inflammation
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Kidney and Urinary Outcomes
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1.
Blood urea nitrogen (BUN) and creatinine levels measures in serum.
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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.
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3.
Abnormalities in urine: proteinuria or haematuria.
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4.
Chronic kidney disease: no definition provided.
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5.
Renal angle tenderness: no definition provided.
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6.
Ferryl-haem derivatives: detected in urine sample.
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Blood and lymphatic system
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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).
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2.
Platelet count- standard laboratory measures.
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3.
Clotting Factors- Clotting factor panel or specific factors like fibrinogen, Factor V, VII, VIII, Fibrinogen degradation products/D-dimer.
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4.
Bleeding – defined clinically using various criterion.
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5.
Clot Quality- measures as per a method developed by Reid
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6.
Other Haematological parameters – complete blood count, packed cell volume.
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7.
Lymphadenopathy/lymphadenitis – no clear clinical criteria provided.
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Composite Outcome
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1.
Clinical recovery as a composite outcome: seven unique definitions were used.
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2.
Complications as a composite outcome: four different definitions were used or not clearly reported.
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3.
Envenoming manifestations: measured compositely as improvement in signs and symptoms of envenoming (systematic alone or together with local).
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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.
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5.
Haemolysis: measured using haemolysis markers (visual haemolysis score level and abnormal lactate dehydrogenase - LDH levels).
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6.
Local Inflammation: Reduction in local inflammatory manifestations such as pain, oedema, and temperature (flushing).
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7.
Prognosis: no clear definition.
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8.
Treatment failure: measured as a composite outcome based on clinical features.
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