scholarly journals Osseointegration Implant Post Coupling With External Prosthetic Limb – Continuation of Previous Case Reports “Stage III”

2014 ◽  
Vol 4 (2) ◽  
pp. 13-16 ◽  
Author(s):  
Ronald Hillock, MD ◽  
Danny Tatum, BCP ◽  
Edward Dolegowski, PT
Keyword(s):  
Medical Center ◽  
Case Reports ◽  
Institutional Review Board ◽  
Concept Design ◽  
Prosthetic Limb ◽  
Therapy Program ◽  
Joint Implant ◽  
Institutional Review ◽  
Physical Therapy Program ◽  
Post Coupling

An ongoing update of the progress case report for the first patient treated with the Longitude™ osseointegration prosthesis implanted in an amputated residual femur is presented. The patient was given an intensive physical therapy program of strengthening and conditioning in anticipation of coupling to the external prosthesis. A custom prosthesis was fabricated based on the Plie’ 2.0 microprocessor knee system. The patient was then successfully trained on use and care of the prosthesis for ambulation without any complications.Keywords: Amputation, OsseointegrationAcknowledgement: Design concept by Concept Design & Development, LLC (CDD,LLC); Development and Manufacturing by Signature Orthopaedics, LTD; Centennial Hills Hospital Medical Center, Las Vegas, NV; and Institutional Review Board (IRB) by Joint Implant Surgery & Research Foundation.

scholarly journals Time Required for Institutional Review Board Review at One Veterans Affairs Medical Center

JAMA Surgery ◽  
2015 ◽  
Vol 150 (2) ◽  
pp. 103 ◽  
Author(s):  
Daniel E. Hall ◽  
Barbara H. Hanusa ◽  
Roslyn A. Stone ◽  
Bruce S. Ling ◽  
Robert M. Arnold
Keyword(s):  
Medical Center ◽  
Veterans Affairs ◽  
Institutional Review Board ◽  
Institutional Review ◽  
Institutional Review Board Review ◽  
Board Review ◽  
Time Required

scholarly journals BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047790
Author(s):  
Brian Driver ◽  
Matthew W Semler ◽  
Wesley H Self ◽  
Adit A Ginde ◽  
Sheetal Gandotra ◽  
...  
Keyword(s):  
Medical Center ◽  
Randomised Trial ◽  
Randomised Clinical Trial ◽  
Orotracheal Intubation ◽  
Statistical Analysis Plan ◽  
Institutional Review Board ◽  
Secondary Outcome ◽  
Intubation Attempt ◽  
Institutional Review ◽  
The Usa

IntroductionIntubation-related complications are less frequent when intubation is successful on the first attempt. The rate of first attempt success in the emergency department (ED) and intensive care unit (ICU) is typically less than 90%. The bougie, a semirigid introducer that can be placed into the trachea to facilitate a Seldinger-like technique of tracheal intubation and is typically reserved for difficult or failed intubations, might improve first attempt success. Evidence supporting its use, however, is from a single academic ED with frequent bougie use. Validation of these findings is needed before widespread implementation.Methods and analysisThe BOugie or stylet in patients Undergoing Intubation Emergently trial is a prospective, multicentre, non-blinded randomised trial being conducted in six EDs and six ICUs in the USA. The trial plans to enrol 1106 critically ill adults undergoing orotracheal intubation. Eligible patients are randomised 1:1 for the use of a bougie or use of an endotracheal tube with stylet for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcome is severe hypoxaemia, defined as an oxygen saturation less than 80% between induction until 2 min after completion of intubation. Enrolment began on 29 April 2019 and is expected to be completed in 2021.Ethics and disseminationThe trial protocol was approved with waiver of informed consent by the Central Institutional Review Board at Vanderbilt University Medical Center or the local institutional review board at an enrolling site. The results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.Trial registration numberClinicalTrials.gov Registry (NCT03928925).

scholarly journals 622 PD-L1 is a potential predictive biomarker for response to RM-1929 treatment in recurrent head and neck squamous cell carcinoma patients

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A658-A658
Author(s):  
C Daniel De Magalhaes Filho ◽  
Chung-Wein Lee ◽  
Nikolai Suslov ◽  
Jerry Fong ◽  
Miguel Garcia-Guzman
Keyword(s):  
Head And Neck ◽  
Response Rate ◽  
Medical Center ◽  
Predictive Biomarker ◽  
Institutional Review Board ◽  
Cancer Center ◽  
University Of Texas ◽  
University Of Oklahoma ◽  
Institutional Review ◽  
Oklahoma Health

BackgroundRM-1929 is an antibody-dye conjugate comprised of cetuximab covalently linked to the photoactivable dye, IRDye® 700DX (IR700). After systemic infusion of RM-1929, illumination of the tumor with 690 nm non-thermal red light activates the drug and results in targeted and rapid tumor necrosis. Previous preclinical data have shown that RM-1929 treatment triggers immunogenic cell death and activates the innate and adaptive immune response. A retrospective analysis of PD-L1 expression from the phase I/IIa clinical trial in patients with recurrent head and neck squamous cell carcinoma (rHNSCC) (NCT02422979) was conducted. The analysis explored correlations of PD-L1 expression, including combined proportion score (CPS) and tumor proportion score (TPS), with clinical outcomes such as response rate and overall survival.MethodsPD-L1 expression prior to RM-1929 treatment was assessed by immunohistochemistry in 18 out of 30 patients enrolled in Part II of the trial, based on sample availability. PD-L1 expression was evaluated using TPS and CPS. Responders were defined as patients that achieved complete response or partial response, and non-responders had either stable disease or progressive disease. Overall survival (OS) was analyzed using the Kaplan-Meier method.ResultsResponders (n=10) had a TPS of 4.3±2.4 (mean±SEM), which was substantially lower than in non-responders (n=8) with a TPS of 39.4±11.8. Similarly, CPS was lower in responders (8.6±3.6) compared to non-responders (50.0±13.5). The best target response rate for all patients included in this analysis was 56%. Patients with CPS=40 had a response rate of 76.9% (n=13) compared to 0% in patients with CPS>40 (n=5). This suggests that a CPS cut-off of =40 led to enrichment of the best target response rate. The median OS of patients with CPS=40 (13.0±0.8 months) was also higher than in patients with CPS>40 (3.1±0.8 months) and in all patients (12.0±2.9 months).ConclusionsThese results suggest that rHNSCC patients with lower PD-L1 expression levels may be more responsive to RM-1929 treatment and CPS/TPS could potentially be predictive biomarkers in identifying patients with a higher probability of benefiting from this treatment. Given the limited number of patients in this analysis, additional clinical trials will be needed to validate PD-L1 expression as an effective predictive biomarker for RM-1929 treatment.AcknowledgementsThe authors would like to thank all patients and their families for their participation in this trial. The authors would also like to thank the following investigators for the contribution of samples included in this trial analysis: Dr. David Cognetti (Thomas Jefferson University Hospital), Dr. Ann M Gillenwater (University of Texas MD Anderson Cancer Center), Dr. Mary Jo Fidler (Rush University Medical Center), Dr. Samith T. Kochuparambil (Virginia Piper Cancer Institute ), Dr. John Campana (University of Colorado Head and Neck Specialists), and Dr. Nilesh R. Vasan (University of Oklahoma Health Sciences Center).Trial RegistrationNCT02422979Ethics ApprovalThe trial was approved by the following Instution Ethics Boards and IRB# as listed: UCSF Institutional Review Board (#17-21904), Thomas Jefferson University, IRB (#16C.328), University of Oklahoma Health Sciences Center Institutional Review Board (#5723), University of Texas MD Anderson Cancer Center - Institutional Review Board (#IRB 2 IRB00002203), Quorum Review IRB (#30458/1), Rush University Medical Center Institutional Review Board (#15030601-IRB01), and Catholic Health Initiatives Institute for Research and Innovation (CIRI) Institutional Review Board (CHIRB) (# IRB00009715).ConsentN/A

scholarly journals Integrity of clinical information in computerized order requisitions for diagnostic imaging

2018 ◽  
Vol 25 (12) ◽  
pp. 1651-1656 ◽  
Author(s):  
Ronilda Lacson ◽  
Romeo Laroya ◽  
Aijia Wang ◽  
Neena Kapoor ◽  
Daniel I Glazer ◽  
...  
Keyword(s):  
Medical Center ◽  
Academic Medical Center ◽  
Clinical Information ◽  
Clinical Decision ◽  
Accurate Diagnosis ◽  
Institutional Review Board ◽  
Institutional Review ◽  
Academic Medical ◽  
Potential Impact ◽  
Kappa Agreement

Abstract Objective Assess information integrity (concordance and completeness of documented exam indications from the electronic health record [EHR] imaging order requisition, compared to EHR provider notes), and assess potential impact of indication inaccuracies on exam planning and interpretation. Methods This retrospective study, approved by the Institutional Review Board, was conducted at a tertiary academic medical center. There were 139 MRI lumbar spine (LS-MRI) and 176 CT abdomen/pelvis orders performed 4/1/2016-5/31/2016 randomly selected and reviewed by 4 radiologists for concordance and completeness of relevant exam indications in order requisitions compared to provider notes, and potential impact of indication inaccuracies on exam planning and interpretation. Forty each LS-MRI and CT abdomen/pelvis were re-reviewed to assess kappa agreement. Results Requisition indications were more likely to be incomplete (256/315, 81%) than discordant (133/315, 42%) compared to provider notes (p < 0.0001). Potential impact of discrepancy between clinical information in requisitions and provider notes was higher for radiologist’s interpretation than for exam planning (135/315, 43%, vs 25/315, 8%, p < 0.0001). Agreement among radiologists for concordance, completeness, and potential impact was moderate to strong (Kappa 0.66-0.89). Indications in EHR order requisitions are frequently incomplete or discordant compared to physician notes, potentially impacting imaging exam planning, interpretation and accurate diagnosis. Such inaccuracies could also diminish the relevance of clinical decision support alerts if based on information in order requisitions. Conclusions Improved availability of relevant documented clinical information within EHR imaging requisition is necessary for optimal exam planning and interpretation.

Is Thoracoscopic Decortication Sufficient for the Treatment of Empyema?

2010 ◽  
Vol 76 (10) ◽  
pp. 1050-1054 ◽  
Author(s):  
Jesse Manunga ◽  
Jemi Olak
Keyword(s):  
Length Of Stay ◽  
Chest Tube ◽  
Medical Center ◽  
Community Acquired Pneumonia ◽  
Institutional Review Board ◽  
Thoracoscopic Approach ◽  
Institutional Review ◽  
Postoperative Length ◽  
Subsequent Intervention

Before thoracoscopy became popular in the 1990s, thoracotomy and decortication was the treatment of choice for empyema thoracis not responding to tube thoracostomy. An Institutional Review Board-approved, retrospective review of all patients treated for empyema between September 1, 2006, and August 31, 2009, at Kern Medical Center was conducted. A total of 37 patients (male = 33; female = 4) with a mean age of 43.7 years were treated. Empyema developed after community-acquired pneumonia (CAP) in 27, traumatic hemothorax (TH) in nine, and other cause in one. For 34 of 36 patients (91%), a thoracoscopic approach was successful. Two of 36 patients required conversion to thoracotomy, whereas one patient required an initial thoracotomy in each case as a result of tenacious adhesions. Mean duration of the chest tube was 4.1 days in patients with CAP and 4.6 days in patients with TH. Mean length of stay after surgery was 6 days for patients with CAP and 9.1 days for patients with TH. Five of 37(13.5%) had complications and one patient died (2.7%). Follow-up was complete for 81.1 per cent of patients, none of whom required a subsequent intervention. Compared with the literature, it appears that the conversion rate to thoracotomy, length of chest tube duration, and postoperative length of stay have decreased as experience has increased.

Publication of Pharmacy Residency Research: A 12-Year Cohort From an Academic Medical Center

2021 ◽  
pp. 089719002110212
Author(s):  
Joshua T. Swan ◽  
Elsie Rizk ◽  
Namhee Kwak ◽  
Jessica Guastadisegni ◽  
Nathaniel Thompson-Moore ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Research Training ◽  
Medical Center ◽  
Academic Medical Center ◽  
Institutional Review Board ◽  
Research Projects ◽  
High Quality Research ◽  
Residency Programs ◽  
Institutional Review ◽  
Academic Medical

Background: Pharmacy residency programs provide research training experiences to residents, and publication is considered an indicator of high-quality research experiences. Objective: This study described attributes of pharmacy residents, residency programs, and residency major research projects and their associations with the outcome of publication in a peer-reviewed journal. Methods: Pharmacy residents who graduated from one academic medical center between 2001 and 2012 were invited to participate via an electronic survey distributed in February 2014. The survey collected attributes of the resident, residency program, and research project. The outcome of publication was self-reported by residents in 2014 and updated in July 2019 using a validated search strategy. Results: This study included 53 resident graduates representing 66 major pharmacy residency projects. Eighteen (27%) projects were published, occurring at an average of 13.8 months after residency graduation. The outcome of publication was more likely for residents with human subjects research experience prior to PGY1 training, residency programs that cultivated resident expertise in Institutional Review Board submission and statistical analysis, and projects with Institutional Review Board approval, a larger number of co-investigators, non-pharmacy co-investigators, and a larger sample size. Conclusion: This cohort of residents, programs, and projects at an academic medical center identified many modifiable attributes that were associated with successful publication of resident research projects. Unfortunately, residency projects rarely used study design features that attenuate bias. Residents and preceptors were perceived as having limited expertise with statistical analysis and database management, which underscores the need to develop research infrastructure to enhance research training for pharmacy students, residents, and preceptors.

scholarly journals Case Report: Angiosarcoma in the Upper Extremity Related to a Nonfunctioning Arteriovenous Fistula

Hand ◽  
2017 ◽  
Vol 12 (5) ◽  
pp. NP132-NP135 ◽  
Author(s):  
Andrea L. Gale ◽  
Rex A. W. Marco ◽  
Shari R. Liberman ◽  
Dmitry Zavlin ◽  
Anthony Echo
Keyword(s):  
Renal Failure ◽  
Differential Diagnosis ◽  
Case Report ◽  
Arteriovenous Fistula ◽  
Upper Extremity ◽  
Hemodialysis Patient ◽  
Case Reports ◽  
Institutional Review Board ◽  
Institutional Review Board Approval ◽  
Institutional Review

Background: Angiosarcoma is a rare but aggressive malignancy with a high predilection for the head and neck. There have been few case reports of the development of angiosarcoma in a nonfunctional arteriovenous fistula in a hemodialysis patient. Methods: After institutional review board approval, a retrospective chart analysis is conducted to present the case of a patient who received plastic surgical treatment at our hospital. Results: We present the case of a 44-year-old male who presented with ischemic changes and paresthesias of the upper extremity associated with the development of angiosarcoma in an arteriovenous fistula. Conclusions: Angiosarcoma remains a rare but important diagnosis to include in the differential diagnosis for upper extremity pain and paresthesias in chronic renal failure and nonfunctioning arteriovenous fistula.

Safety of Intravenous Push Ertapenem Compared to Intravenous Piggyback at a Tertiary Academic Medical Center

2021 ◽  
pp. 089719002110383
Author(s):  
Michael J. Corrado ◽  
Andrew Riselli ◽  
Kevin C. McLaughlin ◽  
Paul M. Szumita ◽  
Kevin E. Anger
Keyword(s):  
Medical Center ◽  
Academic Medical Center ◽  
Healthcare Systems ◽  
Institutional Review Board ◽  
P Value ◽  
Single Center ◽  
Infusion Site ◽  
Patients Âgés ◽  
Institutional Review ◽  
Academic Medical

Background: Recent shortages of intravenous (IV) fluids have resulted in healthcare systems converting administration of many medications from IV piggyback (IVPB) to IV push (IVP). Administering medications via IVP presents numerous advantages; however, IV site reactions such as phlebitis and infiltration may occur. Objective: The objective of this analysis is to evaluate the infusion site safety of ertapenem given as peripheral IVP compared to IVPB in adult patients. Methods: This was an institutional review board–approved, single-center, retrospective study. Patients, ages 18 or older, receiving IV ertapenem were identified. The major endpoints analyzed were IV site reactions including phlebitis and infiltration. The Naranjo Nomogram was utilized to assess the causality of the reactions to determine the likelihood of whether the event was caused by the medication itself or other factors. Results: To date, 283 administrations (92 patients) in the IVP group and 319 administrations (82 patients) in the IVPB group were analyzed. There were 13 IV site reactions compared to 8 in the IVP vs IVPB group, respectively ( P-value = 0.16). Ten of the events in the IVP group were deemed “possible” and 2 deemed “doubtful,” while the remaining event was considered “probable” per the Naranjo Nomogram. Of the events in the IVPB group, all 8 were found to be “possible.” Conclusion: The administration of IVP ertapenem showed comparable rates of infusion site reactions compared to IVPB. Implementation of IVP ertapenem appears to be associated with infusion site safety similar to IVPB and should be considered safe to administer.

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