Reliability, validity, and minimal detectable change of the push-off test scores in assessing upper extremity weight-bearing ability.

STUDY DESIGN: Clinical measurement study. INTRODUCTION: The push-off test (POT) was recently conceived and found to be reliable and valid for assessing weight bearing through injured wrist or elbow. However, further research with larger sample can lend credence to the preliminary findings supporting the use of the POT. PURPOSE OF THE STUDY: This study examined the interrater reliability, construct validity, and measurement error for the POT in patients with wrist conditions. METHODS: Participants with musculoskeletal (MSK) wrist conditions were recruited. The performance on the POT, grip isometric strength of wrist extensors was assessed. The shortened version of the Disabilities of the Arm, Shoulder and Hand and numeric pain rating scale were completed. The intraclass correlation coefficient assessed interrater reliability of the POT. Pearson correlation coefficients (r) examined the concurrent relationships between the POT and other measures. The standard error of measurement and the minimal detectable change at 90% confidence interval were assessed as measurement error and index of true change for the POT. RESULTS: A total of 50 participants with different elbow or wrist conditions (age: 48.1 ± 16.6 years) were included in this study. The results of this study strongly supported the interrater reliability (intraclass correlation coefficient: 0.96 and 0.93 for the affected and unaffected sides, respectively) of the POT in patients with wrist MSK conditions. The POT showed convergent relationships with the grip strength on the injured side (r = 0.89) and the wrist extensor strength (r = 0.7). The POT showed smaller standard error of measurement (1.9 kg). The minimal detectable change at 90% confidence interval for the POT was 4.4 kg for the sample. CONCLUSIONS: This study provides additional evidence to support the reliability and validity of the POT. This is the first study that provides the values for the measurement error and true change on the POT scores in patients with wrist MSK conditions. Further research should examine the responsiveness and discriminant validity of the POT in patients with wrist conditions.

A 6-month inhalation study to characterize the toxicity, pharmacokinetics, and pharmacodynamics of human insulin inhalation powder (HIIP) in beagle dogs.

The purpose of this study was to characterize the toxicity, pharmacokinetics, and pharmacodynamics of human insulin inhalation powder (HIIP) in beagle dogs when administered daily as an aerosolized dry powder formulation for 26 weeks via head-only inhalation. Conscious beagle dogs were exposed for 15 mins/day to an air control, placebo, maximal placebo (approximately three-fold the placebo dose), or one of three doses of HIIP (mean inhaled doses of 80, 240, or 701 microg/kg/day for the HIIP-low, HIIP-mid, and HIIP-high dose, respectively), The mass median aerodynamic diameters (MMAD) were between 2 and 3 microm and geometric standard deviation (GSD) values were approximately 2 across the groups, which is the ideal size range for favorable lung deposition. All groups were comprised of four dogs/sex, with the air control, HIIP-high, and maximal placebo groups having an additional two dogs/sex as recovery subgroups. Concentrations of serum insulin and glucose were determined from blood samples obtained following the first and last exposure for evaluation of the pharmacokinetics and pharmacodynamics of HIIP. Dose-related exposure (C(max), AUC) to inhaled insulin was observed with rapid absorption and no apparent gender differences or accumulation after repeated inhalation exposures for 26 weeks. The expected pharmacological effect of insulin was observed with dose-related decreases in serum glucose levels following HIIP administration. There were no toxic effects observed including no HIIP or placebo treatment-related effects on mean body weights, absolute body weight changes, clinical observations, food consumption, respiratory function parameters, ophthalmic examinations, electrocardiograms, heart rates, clinical pathology, or urinalysis. Similarly, there were no HIIP or placebo treatment-related effects on pulmonary assessments that included respiratory function parameters, bronchial alveolar lavage assessments, organ weights, or macroscopic and microscopic evaluations, including lung cell proliferation indices. HIIP was considered to have either low or no immunogenic potential in dogs. The no-observed-adverse-effect level (NOAEL) and maximum tolerated dose were the average inhaled dose of 701 microg insulin/kg/day.