Effectiveness and efficiency of telerehabilitation on functionality after spinal cord injury: A matched case-control study.

BACKGROUND: Telerehabilitation in spinal cord injury (teleSCI) is a growing field that can improve access to care and health outcomes in patients with spinal cord injury (SCI). The clinical effectiveness of teleSCI is not known. OBJECTIVES: To compare independence in activities of daily living and mobility capacity in patients following teleSCI and matched controls undergoing traditional rehabilitation. DESIGN: Matched case-control study. SETTING: TeleSCI occurring in home setting (cases) versus traditional rehabilitation on inpatient unit (controls). PARTICIPANTS: Forty-two consecutive patients with SCI followed with teleSCI were compared to 42 historical rehabilitation inpatients (controls) matched for age, time since injury to rehabilitation admission, level of injury (paraplegia/tetraplegia), complete or incomplete injury, and etiology (traumatic/nontraumatic). The teleSCI group (n = 42) was also compared to the complete cohort of historical controls (n = 613). INTERVENTIONS: The teleSCI group followed home-based telerehabilitation (3.5 h/day, 5 days/week, 67 days average duration) and historical controls followed in-person rehabilitation. MAIN OUTCOME MEASURE(S): The Functional Independence Measure (FIM), the Spinal Cord Independence Measure (SCIM) and the Walking Index for Spinal Cord Injury (WISCI). We formally compared gains, efficiency and effectiveness. International Standards for Neurological Classification of Spinal Cord Injury and the American Spinal Injury Association Impairment Scale (AIS) were used. RESULTS: The teleSCI group (57.1% nontraumatic, 71.4% paraplegia, 73.8% incomplete, 52.4% AIS grade D) showed no significant differences compared with historical controls in AIS grades, neurological levels, duration, gains, efficiency and effectiveness in FIM, SCIM, or WISCI, although the teleSCI cohort had significantly higher admission FIM scores compared with the complete cohort of historical controls. CONCLUSIONS: TeleSCI may provide similar improvements in mobility and functional outcomes as traditional rehabilitation in medically stable patients (predominantly with paraplegia and motor incomplete SCI) when provided with appropriate support and equipment.

A Measurement Scale to Assess Children's Satisfaction with Hospitalization in the Andalusian Population.

Background: Patient satisfaction is a principal indicator in the evaluation of the stay of pediatric patients in hospitals, since its consequences can emotionally interfere with health treatment. The aim of this study was to obtain a valid scale to assess children's satisfaction with their time spent as a patient in an Andalusian hospital. Method: The Children's Satisfaction with Hospitalization Questionnaire (CSHQ) was applied to 623 pediatric patients hospitalized in Andalusia. An exploratory factor analysis (EFA) showed one dimension underlying the children's satisfaction with their hospitalization. After that, we developed a depuration analysis process to achieve a valid and unidimensional scale to assess children's satisfaction. Results: The eleven-item one-dimension solution showed suitable consistency and goodness-of-fit indices. The final scale addresses hosting aspects as the main dimension of a minor's satisfaction in Andalusian hospitals. Conclusion: A unidimensional scale has been determined for the assessment of children's satisfaction with their stay in Andalusian hospitals based on hosting aspects. Nonetheless, other dimensions underlying the satisfaction of patients should also be considered.

Influence of histidine on the stability and physical properties of a fully human antibody in aqueous and solid forms.

PURPOSE: The aim of the study was to investigate the effect of histidine on the stability and physical properties of a fully human anti-IL8 monoclonal antibody (ABX-IL8) in aqueous and solid forms. METHODS: Using a fractional factorial design, we tested many excipients, including histidine, sucrose, and other commonly used excipients, on the stability and physical properties of the antibody in both liquid and lyophilized forms. Antibody stability and physical properties were evaluated using size-exclusion high-performance liquid chromatography (SEC-HPLC), sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), and a viscometer. Residual moisture content was determined by coulometric Karl Fischer titrator. Differential scanning calorimetry (DSC) was used to detect the glass transition temperatures (Tg) of the solid cakes and melting temperatures (Tm) of the antibody in liquid formulations. Fourier-transform infrared (FTIR) spectroscopy was used to examine the overall secondary structure. RESULTS: Increasing the histidine concentration in the bulk solution inhibited the increases of high-molecular-weight (HMW) species and aggregates upon lyophilization and storage. In addition, histidine bulk enhanced solution stability of the antibody under freezing and thermal stress conditions, as evidenced by the lower levels of aggregates. Furthermore, histidine reduced viscosity of the antibody solution, which is desirable for the manufacture of the dosage form. However, high concentrations of histidine in liquid formulations led to coloration of the solution and high levels of aggregates on storage at elevated temperature (40 degrees C) after the formulations were exposed to stainless steel containers during bulk freezing-thawing. CONCLUSIONS: Histidine enhanced the stability of ABX-IL8 in both aqueous and lyophilized forms. Histidine also improved the physical properties such as reducing the solution viscosity. Liquid formulations containing high concentrations of histidine should not be stored in stainless steel tanks at elevated temperatures.