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

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 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 �: 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. Conclusions: Telephone administration of the PSFS provides valid, reliable, and consistent data for the assessment of recovery from snakebite envenomation

A central nervous system-focused treatment approach for people with frozen shoulder: protocol for a randomized clinical trial

Background: Frozen shoulder (FS) is a musculoskeletal condition of poorly understood etiology that results in shoulder pain and large mobility deficits. Despite some physical therapy interventions, such as joint mobilization and exercise, having shown therapeutic benefit, a definitive treatment does not currently exist. The aim of this study will be to compare the effectiveness of a central nervous system (CNS)-directed treatment program versus a standard medical and physical therapy care program on outcomes in participants with FS. Methods/design: The study is a two-group, randomized clinical trial with blinding of participants and assessors. Participants will be recruited via referrals from orthopedic surgeons and physical therapists, community-based advertisements, private care practices and hospitals. Participants will be randomized to receive either a CNS-focused treatment program or standard medical and physical therapy care. The Shoulder Pain And Disability Index (SPADI) will be the primary outcome, while the Numeric Pain Rating Scale (NPRS), shoulder range of movement (ROM), The Patient Specific Functional Scale, two-point discrimination threshold and laterality judgement accuracy will be the secondary outcomes. Assessment will occur at baseline, at the end of the treatment program (week 10), and at 3 and 6 months' follow-up. Discussion: Preliminary data suggest that treatments that target CNS function are a promising approach to the treatment of people with shoulder pain including patients with FS. In the context of modest effects from most available physical therapy treatments for FS, this CNS-focused approach may lead to improved clinical outcomes. The trial should determine if the CNS-directed program is more effective than traditional interventions at reducing pain intensity and improving function in a FS cohort and will follow up participants for 6 months, providing important information on the persistence of any treatment effects.This work is funded by the Conselleria de Educación, Investigación, Cultura y Deporte de la Generalitat Valenciana, Spain (GV/2016).Ye