VALIDATION AND PERFORMANCE OF POINT-OF-CARE RAPID CYP2C19 GENOTYPING IN THE TAILOR-PCI MULTICENTER INTERNATIONAL RANDOMIZED CLINICAL TRIAL

Background Urinary tract infection (UTI) is a common disease in childhood. A sterile collection of urine samples using suprapubic aspiration (SPA) and bladder catheterization (BC) is helpful for rapid and accurate diagnosis of UTI in infants. With the advent of point-of-care ultrasound (POCUS), the use of ultrasound by non-radiologists at the patient’s bedside, great advancement has been noticed in various medical fields. Considering the importance and advantages of using POCUS in the physical examination and guiding procedures, the authors aimed to compare urine sampling’s success rate by SPA, BC, and POCUS guided SPA (POCUS-SPA) in infants performed by three pediatricians. Materials and methods This study is a randomized clinical trial conducted on 114 neonates and infants with suspected UTI admitted to 17-Shahrivar children’s hospital from April 2017 to September 2019. Neonates and infants were randomly assigned to three groups of BC, SPA, and POCUS-SPA. The primary outcome was the success of sampling defined by obtaining 1cc of urine in each method. The secondary outcome was assessing the pain level. Results Results showed that the POCUS-SPA had the highest success rate in urine sampling, and a statistically significant relation was noted among the three groups (P = 0.0001). From 38 patients in each group, 37 patients of POCUS-SPA (97.4%), 34 patients of BC (89.5%), and 23 patients of SPA (60.5%) had a successful sampling. Most of the patients in all three groups experienced severe pain. Conclusions In the current study, results showed that the POCUS-SPA significantly increased the success rate of urine sampling and most of the patients in all three groups had severe pain. Based on the shortage of access to radiologists in emergency setups, it seems that the POCUS-SPA by the pediatricians can be one of the most appropriate and applicable diagnostic methods in infants with UTI.

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A Randomized Clinical Trial to Assess the Effect of Statins on Skeletal Muscle Function and Performance: Rationale and Study Design

Preventive Cardiology ◽

10.1111/j.1751-7141.2009.00063.x ◽

2010 ◽

Cited By ~ 3

Author(s):

Paul D. Thompson ◽

Beth A. Parker ◽

Priscilla M. Clarkson ◽

Linda S. Pescatello ◽

C. Michael White ◽

...

Keyword(s):

Skeletal Muscle ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Study Design ◽

Muscle Function ◽

Skeletal Muscle Function ◽

And Performance

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A randomized clinical trial comparing point-of-care platelet function assays and bleeding time in healthy subjects treated with aspirin or clopidogrel

Platelets ◽

10.3109/09537104.2011.604806 ◽

2011 ◽

Vol 23 (4) ◽

pp. 249-258 ◽

Cited By ~ 6

Author(s):

Fabian Chen ◽

Victor Maridakis ◽

Edward A. O’neill ◽

Chan Beals ◽

Waldemar Radziszewski ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Platelet Function ◽

Healthy Subjects ◽

Bleeding Time ◽

Point Of Care ◽

Platelet Function Assays

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Using a microprocessor knee (C-Leg) with appropriate foot transitioned individuals with dysvascular transfemoral amputations to higher performance levels: a longitudinal randomized clinical trial

Journal of NeuroEngineering and Rehabilitation ◽

10.1186/s12984-021-00879-3 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Chandrasekaran Jayaraman ◽

Chaithanya K. Mummidisetty ◽

Mark V. Albert ◽

Robert Lipschutz ◽

Shenan Hoppe-Ludwig ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Clinical Outcomes ◽

Steady Increase ◽

Reimbursement Policy ◽

Transfemoral Amputation ◽

Lower Limb Prosthesis ◽

Transfemoral Amputees ◽

And Performance

Abstract Background Individuals with transfemoral amputations who are considered to be limited community ambulators are classified as Medicare functional classification (MFCL) level K2. These individuals are usually prescribed a non-microprocessor controlled knee (NMPK) with an appropriate foot for simple walking functions. However, existing research suggests that these individuals can benefit from using a microprocessor controlled knee (MPK) and appropriate foot for their ambulation, but cannot obtain one due to insurance policy restrictions. With a steady increase in older adults with amputations due to vascular conditions, it is critical to evaluate whether advanced prostheses can provide better safety and performance capabilities to maintain and improve quality of life in individuals who are predominantly designated MFCL level K2. To decipher this we conducted a 13 month longitudinal clinical trial to determine the benefits of using a C-Leg and 1M10 foot in individuals at K2 level with transfemoral amputation due to vascular disease. This longitudinal clinical trial incorporated recommendations prescribed by the lower limb prosthesis workgroup to design a study that can add evidence to improve reimbursement policy through clinical outcomes using an MPK in K2 level individuals with transfemoral amputation who were using an NMPK for everyday use. Methods Ten individuals (mean age: 63 ± 9 years) with unilateral transfemoral amputation due to vascular conditions designated as MFCL K2 participated in this longitudinal crossover randomized clinical trial. Baseline outcomes were collected with their current prosthesis. Participants were then randomized to one of two groups, either an intervention with the MPK with a standardized 1M10 foot or their predicate NMPK with a standardized 1M10 foot. On completion of the first intervention, participants crossed over to the next group to complete the study. Each intervention lasted for 6 months (3 months of acclimation and 3 months of take-home trial to monitor home use). At the end of each intervention, clinical outcomes and self-reported outcomes were collected to compare with their baseline performance. A generalized linear model ANOVA was used to compare the performance of each intervention with respect to their own baseline. Results Statistically significant and clinically meaningful improvements were observed in gait performance, safety, and participant-reported measures when using the MPK C-Leg + 1M10 foot. Most participants were able to achieve higher clinical scores in gait speed, balance, self-reported mobility, and fall safety, while using the MPK + 1M10 combination. The improvement in scores were within range of scores achieved by individuals with K3 functional level as reported in previous studies. Conclusions Individuals with transfemoral amputation from dysvascular conditions designated MFCL level K2 benefited from using an MPK + appropriate foot. The inference and evidence from this longitudinal clinical trial will add to the knowledgebase related to reimbursement policy-making. Trial registration This study is registered on clinical trials.gov with the study title “Functional outcomes in dysvascular transfemoral amputees” and the associated ClinicalTrials.gov Identifier: NCT01537211. The trial was retroactively registered on February 7, 2012 after the first participant was enrolled.

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