Abstract
ObjectivesAlthough more than 1.8 million people survive snakebite envenomation each year, their recovery is understudied. Obtaining long-term follow-up is challenging in both high- and low-resource settings. The Patient-Specific Functional Scale (PSFS) is an easily administered, well-accepted patient-reported outcome that is validated for assessing limb recovery from snakebite envenomation. We studied whether the PSFS is valid and reliable when administered by telephone.MethodsThis is a secondary analysis of data from a randomized clinical trial. We analyzed the results of PSFS collected in-person on days 3, 7, 14, 21, and 28 and by telephone on days 10, 17, and 24. We assessed the following scale psychometric properties: (a) content validity (ceiling and floor effects), (b) internal structure and consistency (Cronbach’s alpha), and (c) temporal and external validity using Intraclass Correlation Coefficient (ICC). Temporal stability was assessed using Spearman’s correlation coefficient and agreement between adjacent in-person and telephonic assessments with Cohen’s kappa. Bland Altman analysis was used to assess differential bias in low and high score results.ResultsData from 74 patients were available for analysis. Floor effects were seen in the early post-injury time points (median: 3 (IQR: 0, 5) at 3 days post-enrollment) and ceiling effects in the late time points (median: 9 (IQR: 8, 10). Internal consistency was good to excellent with both in-person (Cronbach α: 0.91 (95%CI 0.88, 0.95)) and telephone administration (0.81 (0.73, 0.89). Temporal stability was also good (ICC: 0.83 (0.72, 0.89) in-person, 0.80 (0.68, 0.88) telephone). A strong linear correlation was found between in-person and telephone administration (Spearman’s ρ: 0.83 (CI: 0.78, 0.84), consistency was assessed as excellent (Cohen’s κ 0.81 (CI: 0.78, 0.84), and Bland Altman analysis showed no systematic bias.ConclusionsTelephone administration of the PSFS provides valid, reliable, and consistent data for the assessment of recovery from snakebite envenomation.
Highlights
A strong linear correlation was found between in-person and telephone administration (Spearman’s ρ: 0.83 (CI: 0.78, 0.84), consistency was assessed as excellent (Cohen’s κ 0.81 (CI: 0.78, 0.84), and Bland Altman analysis showed no systematic bias
Snakebite envenomation is a neglected tropical disease that affects as many as 1.8 million people per year with the overwhelming majority of patients from low- and middle-income countries (LMICs)
An essential element of high-quality clinical research is the use of patient-centered outcome measures, such as patient reported outcomes (PROs)
Summary
Snakebite envenomation is a neglected tropical disease that affects as many as 1.8 million people per year with the overwhelming majority of patients from low- and middle-income countries (LMICs). Validation of telephone PSFS in snakebite patients disability.[1,2,3,4,5] To date, almost no clinical trials have attempted to study the impact of treatment interventions on snakebite-caused disability.[6,7,8,9,10] researchers face substantial challenges to performing high quality trials, and research instruments used to assess disability and recovery must be both validated and practical to administer in low-resource settings. No practical, inexpensive, reliable, validated PROs exist that are appropriate for evaluating patients with snakebite envenomation.[11, 12] This impacts snakebite envenomation research, in LMICs due to cost and logistical barriers to in-person administration of a PRO. With the widespread use of cellphones in LMICs, a telephone-administered, validated PRO would be an inexpensive and useful tool in future snakebite envenomation research. With the widespread use of cellphones in LMICs, a telephone-administered, validated PRO would be an inexpensive and useful tool in future snakebite envenomation research. [13]
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