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Validity and reliability of telephone administration of the patient-specific functional scale for the assessment of recovery from snakebite envenomation.

ABSTRACT: OBJECTIVES:Although 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. METHODS:This 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. RESULTS:Data 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 ?: 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 ?: 0.83 (CI: 0.78, 0.84), consistency was assessed as excellent (Cohen's ? 0.81 (CI: 0.78, 0.84), and Bland Altman analysis showed no systematic bias. CONCLUSIONS:Telephone administration of the PSFS provides valid, reliable, and consistent data for the assessment of recovery from snakebite envenomation.

SUBMITTER: Theophanous RG

PROVIDER: S-EPMC6934321 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Validity and reliability of telephone administration of the patient-specific functional scale for the assessment of recovery from snakebite envenomation.

Theophanous Rebecca G RG Vissoci Joao Ricardo Nickenig JRN Wen Fan Hui FH Griffin S Michelle SM Anderson Victoria E VE Mullins Michael E ME Brandehoff Nicklaus P NP Quackenbush Eugenia B EB Bush Sean P SP Toschlog Eric A EA Greene Spencer C SC Sharma Kapil K Kleinschmidt Kurt K Charlton Nathan P NP Rose S Rutherfoord SR Schwartz Richard R Lewis Brandon B Lavonas Eric J EJ Gerardo Charles J CJ

PLoS neglected tropical diseases 20191213 12

<h4>Objectives</h4>Although 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.<h4>Methods</h4> ...[more]

PMID: 31834923

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Project description: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.

Project description:BackgroundThe Patient Benefit Assessment Scale for Hospitalised Older Patients (P-BAS HOP) is a tool which is capable of both identifying the priorities of the individual patient and measuring the outcomes relevant to him/her, resulting in a Patient Benefit Index (PBI) with range 0-3, indicating how much benefit the patient had experienced from the admission. The aim of this study was to evaluate the reliability, validity, responsiveness and interpretability of the P-BAS HOP.MethodsA longitudinal study among hospitalised older patients with a baseline interview during hospitalisation and a follow-up by telephone 3 months after discharge. Test-retest reliability of the baseline and follow-up questionnaire were tested. Percentage of agreement, Cohen's kappa with quadratic weighting and maximum attainable kappa were calculated per item. The PBI was calculated for both test and retest of baseline and follow-up and compared with Intraclass Correlation Coefficient (ICC). Construct validity was tested by evaluating pre-defined hypotheses comparing the priority of goals with experienced symptoms or limitations at admission and the achievement of goals with progression or deterioration of other constructs. Responsiveness was evaluated by correlating the PBI with the anchor question 'How much did you benefit from the admission?'. This question was also used to evaluate the interpretability of the PBI with the visual anchor-based minimal important change distribution method.ResultsReliability was tested with 53 participants at baseline and 72 at follow-up. Mean weighted kappa of the baseline items was 0.38. ICC between PBI of the test and retest was 0.77. Mean weighted kappa of the follow-up items was 0.51. ICC between PBI of the test and retest was 0.62. For the construct validity, tested in 451 participants, all baseline hypotheses were confirmed. From the follow-up hypotheses, tested in 344 participants, five of seven were confirmed. The Spearman's correlation coefficient between the PBI and the anchor question was 0.51. The optimal cut-off point was 0.7 for 'no important benefit' and 1.4 points for 'important benefit' on the PBI.ConclusionsAlthough the concept seems promising, the reliability and validity of the P-BAS HOP appeared to be not yet satisfactory. We therefore recommend adapting the P-BAS HOP.

Project description:BackgroundThe Patient Benefit Assessment Scale for Hospitalised Older Patients (P-BAS HOP) is a tool developed to both identify the priorities of the individual patient and to measure the outcomes relevant to him/her, resulting in a Patient Benefit Index (PBI), indicating how much benefit the patient had experienced from the hospitalisation. The reliability and the validity of the P-BAS HOP appeared to be not yet satisfactory and therefore the aims of this study were to adapt the P-BAS HOP and transform it into a picture version, resulting in the P-BAS-P, and to evaluate its feasibility, reliability, validity, responsiveness and interpretability.MethodsProcess of instrument development and evaluation performed among hospitalised older patients including pilot tests using Three-Step Test-Interviews (TSTI), test-retest reliability on baseline and follow-up, comparing the PBI with Intraclass Correlation Coefficient (ICC), and hypothesis testing to evaluate the construct validity. Responsiveness of individual P-BAS-P scores and the PBI with two different weighing schemes were evaluated using anchor questions. Interpretability of the PBI was evaluated with the visual anchor-based minimal important change (MIC) distribution method and computation of smallest detectable change (SDC) based on ICC.ResultsFourteen hospitalised older patients participated in TSTIs at baseline and 13 at follow-up after discharge. After several adaptations, the P-BAS-P appeared feasible with good interviewer's instructions. The pictures were considered relevant and helpful by the participants. Reliability was tested with 41 participants at baseline and 50 at follow-up. ICC between PBI1 and PBI2 of baseline test and retest was 0.76, respectively 0.73. At follow-up 0.86, respectively 0.85. For the construct validity, tested in 169 participants, hypotheses regarding importance of goals were confirmed. Regarding status of goals, only the follow-up status was confirmed, baseline and change were not. The responsiveness of the individual scores and PBI were weak, resulting in poor interpretability with many misclassifications. The SDC was larger than the MIC.ConclusionsThe P-BAS-P appeared to be a feasible instrument, but there were methodological barriers for the evaluation of the reliability, validity, and responsiveness. We therefore recommend further research into the P-BAS-P.

Project description:IntroductionA core outcome set (COS) is a minimal list of consensus outcomes that should be used in all intervention research in a specific domain. COS enhance the ability to undertake meaningful comparisons and to understand the benefits or harms of different treatments. A first step in developing a COS is to identify outcomes that have been used previously. We did this global systematic review to provide the foundation for development of a region-specific COS for snakebite envenomation. Methods: We searched 15 electronic databases, eight trial registries, and reference lists of included studies to identify reports of relevant trials, protocols, registry records and systematic reviews. We extracted verbatim data on outcomes, their definitions, measures, and time-points. Outcomes were classified as per an existing outcome taxonomy, and we identified unique outcomes based on similarities in the definition and measurement of the verbatim outcomes.ResultsWe included 107 records for 97 studies which met our inclusion criteria. These reported 538 outcomes, with a wide variety of outcome measures, definitions, and time points for measurement. We consolidated these into 88 unique outcomes, which we classified into core areas of mortality (1, 1.14 %), life impact (6, 6.82%), resource use (15, 17.05%), adverse events (7, 7.95%), physiological/clinical (51, 57.95%), and composite (8, 9.09%) outcomes. The types of outcomes varied by the type of intervention, and by geographic region. Only 15 of the 97 trials (17.04%) listed Patient Related Outcome Measures (PROMS).ConclusionTrials evaluating interventions for snakebite demonstrate heterogeneity on outcomes and often omit important information related to outcome measurement (definitions, instruments, and time points). Developing high quality, region-specific COS for snakebite could inform the design of future trials and improve outcome reporting. Measurement of PROMS, resource use and life impact outcomes in trials on snakebite remains a gap.

Dataset Information

Validity and reliability of telephone administration of the patient-specific functional scale for the assessment of recovery from snakebite envenomation.

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Validity and reliability of telephone administration of the patient-specific functional scale for the assessment of recovery from snakebite envenomation.

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