Clinical Evaluation of a Flexible Fecal Incontinence Management System

2007 ◽  
Vol 16 (4) ◽  
pp. 384-393 ◽  
Author(s):  
Anantha Padmanabhan ◽  
Mark Stern ◽  
Judith Wishin ◽  
Mari Mangino ◽  
Karen Richey ◽  
...  
Keyword(s):  
Critical Care ◽  
Fecal Incontinence ◽  
Management System ◽  
Rectal Mucosa ◽  
The United States ◽  
Skin Condition ◽  
Hospitalized Patients ◽  
Skin Breakdown ◽  
Reduce Risk

Background Management of fecal incontinence is a priority in acute and critical care to reduce risk of perineal dermatitis and transmission of nosocomial infections. Objective To evaluate the safety of the Flexi-Seal Fecal Management System in hospitalized patients with diarrhea and incontinence. Methods A prospective, single-arm clinical study with 42 patients from 7 hospitals in the United States was performed. The fecal management system could be used for up to 29 days. The first 11 patients (all from critical care) underwent endoscopic proctoscopy at baseline; 8 of these had endoscopy again after treatment. The remaining 31 patients (from critical or acute care) did not have endoscopy. Results Rectal mucosa was healthy after use of the device in all patients who had baseline and follow-up endoscopy. Physicians and nurses reported that the system was easy to insert, remove, and dispose of; its use improved management of fecal incontinence; and it was practical, caregiver- and patient-friendly, time-efficient, and efficacious. Skin condition improved or was maintained in more than 92% of patients. Patients’ reports of discomfort, pain, burning, or irritation were uncommon. Adverse events were reported for 11 patients (26%). Death (considered unrelated to study treatment) occurred in 5 patients, 2 patients had generalized skin breakdown, and 1 patient had gastrointestinal bleeding after 4 days of treatment. Conclusions The fecal management system can be used safely in hospitalized patients with diarrhea and fecal incontinence. Additional well-designed, controlled clinical trials may help to measure clinical and economic outcomes associated with the device.

Safety and Environmental Management Systems (SEMS) Audit Methodology

2016 ◽  
Author(s):  
Charlie Williams ◽  
Om Chawla
Keyword(s):  
Environmental Management ◽  
Management System ◽  
The United States ◽  
White Paper ◽  
Environmental Management System ◽  
Management Systems ◽  
Environmental Management Systems ◽  
Regulatory Requirements ◽  
Levels Of Detail ◽  
Reduce Risk

Abstract Introduction In the United States, the Bureau of Safety and Environmental Enforcement (BSEE) requires an offshore lease operator to implement a Safety and Environmental Management System (SEMS), and to have it audited at least once every 3 years to evaluate its compliance to the regulatory requirements detailed in 30 CFR 250, Subpart S. The first round of these SEMS audits, which concluded in 2013, was executed using varying audit styles – from system audits through to compliance audits. These varying audit styles, in turn, lead to differing types output, levels of detail, format and presentation.These diverse approaches may have been due, at least in part, to disparities in the expectations of stakeholders, differing interpretations of the use of the Center for Offshore Safety's (COS) SEMS Audit Protocol tools, use of other audit protocols, the experience-level of individual auditors, and the newness of the regulation. System audits are intended to be a holistic assessment of a system, its elements, and how the elements work together to achieve system objectives. Compliance audits, on the other hand, are intended to assess adherence to specific requirements. This white paper proposes that both types of audits should be used in tandem to reduce risk and increase confidence that a management system, and its verification programs, is operating as designed and meeting regulatory and company requirements.

ADJUSTABLE-VOLUME PROSTHETIC SOCKETS: MARKET OVERVIEW AND VALUE PROPOSITIONS

2021 ◽  
Vol 4 (2) ◽  
Author(s):  
Tyler Klenow ◽  
Joel Schulz
Keyword(s):  
The United States ◽  
Fee For Service ◽  
Market Penetration ◽  
Health Providers ◽  
Prosthetic Socket ◽  
Skin Breakdown ◽  
Lack Of Fit ◽  
Value Propositions ◽  
Care Outcomes

The prosthetic socket is commonly considered to be the most important part of the prosthesis and lack of fit can lead to skin breakdown, reduction in wear, reduction in activity, and consequential deleterious health effects. Furthermore, approximately 90% of amputations are due to a vascular etiology, which affect fluid retention regularity, and even small limb volume fluctuations can lead to lack of fit. Adjustability in the socket volume has been suggested as a potential solution to common fit issues but has lacked market penetration mostly due to lack of reimbursement. Despite this there are several adjustable-volume sockets emerging on the market today including prefabricated, modular, custom with adjustable-volume component, custom with adjustable-volume feature, and adjustable-hybrid sockets. Prefabricated sockets are mass produced in common sizes and fit directly to the patient by a prosthetist using pad kits, BOA dials, or straps. Modular sockets are assembled to a patient or model with panels or struts attached to an adjustable base. Custom sockets with adjustable-volume elements are traditionally-fabricated sockets made to a model of a patient’s limb with a volume-adjustable component added or volume-adjustable feature built in. Custom-hybrid sockets are made custom to a model of the patient’s limb and incorporate several aspects of the previous socket types and include some radically-unique design aspects which cannot be limited to one category. These adjustable-volume sockets offer several advantages to traditional rigid-volume sockets for the patient, prosthetist, and providing clinic. The micro-adjustability for the patient allows them to alter fit without removing the socket, maintaining a more intimate fit throughout the day than traditional sockets. The macro-adjustability for the prosthetist allows for increased options for fit customization including the ability to reverse or undo changes without necessarily re-making the socket. This allows for the most optimal fit for the patient. Adjustable volume also present efficiencies in the fitting process by simplifying or eliminating steps including residual limb shape capture, form modification, diagnostic fabrication, iterative alteration, and definitive fabrication with the different socket types affecting different steps. Due to these factors, adjustable-volume sockets have disrupted the market to the point where reimbursement reform is needed including additional L-codes in the United States and fee-for-service or fee-for-outcome associated with prosthetic follow-up care. Prosthetic care should also be separated from durable medical equipment to allow for alternative reimbursement models. As reimbursement adapts prosthetists must adapt correspondingly to differentiate their skillset from other allied health providers including incorporating more objective methods to show superior care outcomes. This adaptation should include a continued push for state and municipal licensure of prosthetists. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/35208/28346 How To Cite: Klenow TD, Schulz J. Adjustable-volume prosthetic sockets: market overview and value propositions. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, Issue 2, No.17 https://doi.org/10.33137/cpoj.v4i2.35208 Corresponding Author: Tyler D. Klenow, MSPO, MBA, CLPO, FAAOPMartin Bionics Clinical CareE-Mail: [email protected] ID: https://orcid.org/0000-0002-6372-2241

scholarly journals AKI in Hospitalized Patients with COVID-19

2020 ◽  
Vol 32 (1) ◽  
pp. 151-160 ◽  
Author(s):  
Lili Chan ◽  
Kumardeep Chaudhary ◽  
Aparna Saha ◽  
Kinsuk Chauhan ◽  
Akhil Vaid ◽  
...  
Keyword(s):  
United States ◽  
Intensive Care ◽  
Observational Study ◽  
Confidence Interval ◽  
Hospital Mortality ◽  
Kidney Function ◽  
The United States ◽  
Hospitalized Patients ◽  
Health Records

BackgroundEarly reports indicate that AKI is common among patients with coronavirus disease 2019 (COVID-19) and associated with worse outcomes. However, AKI among hospitalized patients with COVID-19 in the United States is not well described.MethodsThis retrospective, observational study involved a review of data from electronic health records of patients aged ≥18 years with laboratory-confirmed COVID-19 admitted to the Mount Sinai Health System from February 27 to May 30, 2020. We describe the frequency of AKI and dialysis requirement, AKI recovery, and adjusted odds ratios (aORs) with mortality.ResultsOf 3993 hospitalized patients with COVID-19, AKI occurred in 1835 (46%) patients; 347 (19%) of the patients with AKI required dialysis. The proportions with stages 1, 2, or 3 AKI were 39%, 19%, and 42%, respectively. A total of 976 (24%) patients were admitted to intensive care, and 745 (76%) experienced AKI. Of the 435 patients with AKI and urine studies, 84% had proteinuria, 81% had hematuria, and 60% had leukocyturia. Independent predictors of severe AKI were CKD, men, and higher serum potassium at admission. In-hospital mortality was 50% among patients with AKI versus 8% among those without AKI (aOR, 9.2; 95% confidence interval, 7.5 to 11.3). Of survivors with AKI who were discharged, 35% had not recovered to baseline kidney function by the time of discharge. An additional 28 of 77 (36%) patients who had not recovered kidney function at discharge did so on posthospital follow-up.ConclusionsAKI is common among patients hospitalized with COVID-19 and is associated with high mortality. Of all patients with AKI, only 30% survived with recovery of kidney function by the time of discharge.

scholarly journals Natural History and Evolution of Anti-Interferon-γ Autoantibody-Associated Immunodeficiency Syndrome in Thailand and the United States

2019 ◽  
Vol 71 (1) ◽  
pp. 53-62 ◽  
Author(s):  
Gloria H Hong ◽  
Ana M Ortega-Villa ◽  
Sally Hunsberger ◽  
Ploenchan Chetchotisakd ◽  
Siriluck Anunnatsiri ◽  
...  
Keyword(s):  
United States ◽  
Natural History ◽  
The United States ◽  
Interferon Γ ◽  
Mycobacterium Abscessus ◽  
Annual Data ◽  
Persistent Infections ◽  
Ifn Γ ◽  
Immunodeficiency Syndrome

Abstract Background The natural history of anti-interferon-γ (IFN-γ) autoantibody-associated immunodeficiency syndrome is not well understood. Methods Data of 74 patients with anti-IFN-γ autoantibodies at Srinagarind Hospital, Thailand, were collected annually (median follow-up duration, 7.5 years). Annual data for 19 patients and initial data for 4 patients with anti-IFN-γ autoantibodies at the US National Institutes of Health were collected (median follow-up duration, 4.5 years). Anti-IFN-γ autoantibody levels were measured in plasma samples. Results Ninety-one percent of US patients were of Southeast Asian descent; there was a stronger female predominance (91%) in US than Thai (64%) patients. Mycobacterium abscessus (34%) and Mycobacterium avium complex (83%) were the most common nontuberculous mycobacteria in Thailand and the United States, respectively. Skin infections were more common in Thailand (P = .001), whereas bone (P < .0001), lung (P = .002), and central nervous system (P = .03) infections were more common in the United States. Twenty-four percent of Thai patients died, most from infections. None of the 19 US patients with follow-up data died. Anti-IFN-γ autoantibody levels decreased over time in Thailand (P < .001) and the United States (P = .017), with either cyclophosphamide (P = .01) or rituximab therapy (P = .001). Conclusions Patients with anti-IFN-γ autoantibodies in Thailand and the United States had distinct demographic and clinical features. While titers generally decreased with time, anti-IFN-γ autoantibody disease had a chronic clinical course with persistent infections and death. Close long-term surveillance for new infections is recommended.

scholarly journals How Family Physicians Practice the Principle of Remission Along the Glycemic Continuum

2020 ◽  
Vol 11 ◽  
pp. 215013272097774
Author(s):  
Stephanie T. Fulleborn ◽  
Paul F. Crawford ◽  
Jeremy T. Jackson ◽  
Christy J.W. Ledford
Keyword(s):  
Type 2 Diabetes ◽  
Medical Record ◽  
The United States ◽  
Case Scenario ◽  
Cross Sectional ◽  
Normal Glucose ◽  
Normal Glucose Regulation

Introduction Recent evidence reveals that diabetes and prediabetes (preDM) can be reversed to normal glucose regulation (NGR) through significant weight loss, but how physicians clinically identify the principles of partial and complete remission of diabetes is largely unknown. Methods As part of the cross-sectional omnibus survey conducted in March 2019 at a professional annual meeting in the United States, physician participants answered case scenario questions about the diagnosis and documentation of patients with preDM and type 2 diabetes (T2DM). Results Of the registered conference attendees, 387 (72.7%) responded. When presented with the initial case of preDM, 201 physicians (70.8%) selected R73.03 Prediabetes. In a follow-up encounter with improved lab results, 118 physicians (58.7%) indicated that they would not chart any diabetes-related code and 62 (30.8%) would chart preDM again. When presented with the case of T2DM, 256 physicians (90.1%) indicated E11.0–E11.9 Type 2 Diabetes. In the follow-up encounter, only 38 (14.8%) coded a diagnosis reflecting remission from T2DM to prediabetes and 211 (82.4%) charted T2DM. Conclusion Physicians may be reluctant to document diabetes regression as there is little evidence for long-term outcomes and “downgrading” the diagnosis in the medical record may cause screenings to be missed. Documenting this regression in the medical record should communicate the accurate point on the continuum of glucose intolerance with both the patient and the care team.

scholarly journals Testing telediagnostic thyroid ultrasound in Peru: a new horizon in expanding access to imaging in rural and underserved areas

2021 ◽  
Author(s):  
T. J. Marini ◽  
S. L. Weiss ◽  
A. Gupta ◽  
Y. T. Zhao ◽  
T. M. Baran ◽  
...  
Keyword(s):  
Thyroid Nodule ◽  
Standard Of Care ◽  
The United States ◽  
Epidemiological Studies ◽  
Thyroid Ultrasound ◽  
Target Region ◽  
Experienced Radiologist ◽  
Significant Difference ◽  
Size Evaluation

Abstract Purpose Thyroid ultrasound is a key tool in the evaluation of the thyroid, but billions of people around the world lack access to ultrasound imaging. In this study, we tested an asynchronous telediagnostic ultrasound system operated by individuals without prior ultrasound training which may be used to effectively evaluate the thyroid and improve access to imaging worldwide. Methods The telediagnostic system in this study utilizes volume sweep imaging (VSI), an imaging technique in which the operator scans the target region with simple sweeps of the ultrasound probe based on external body landmarks. Sweeps are recorded and saved as video clips for later interpretation by an expert. Two operators without prior ultrasound experience underwent 8 h of training on the thyroid VSI protocol and the operation of the telemedicine platform. After training, the operators scanned patients at a health center in Lima. Telediagnostic examinations were sent to the United States for remote interpretation. Standard of care thyroid ultrasound was performed by an experienced radiologist at the time of VSI examination to serve as a reference standard. Results Novice operators scanned 121 subjects with the thyroid VSI protocol. Of these exams, 88% were rated of excellent image quality showing complete or near complete thyroid visualization. There was 98.3% agreement on thyroid nodule presence between VSI teleultrasound and standard of care ultrasound (Cohen’s kappa 0.91, P < 0.0001). VSI measured the thyroid size, on average, within 5 mm compared to standard of care. Readers of VSI were also able to effectively characterize thyroid nodules, and there was no significant difference in measurement of thyroid nodule size (P = 0.74) between VSI and standard of care. Conclusion Thyroid VSI telediagnostic ultrasound demonstrated both excellent visualization of the thyroid gland and agreement with standard of care thyroid ultrasound for nodules and thyroid size evaluation. This system could be deployed for evaluation of palpable thyroid abnormalities, nodule follow-up, and epidemiological studies to promote global health and improve the availability of diagnostic imaging in underserved communities.

scholarly journals SAT0172 UTILIZATION OF HYDROXYCHLOROQUINE AND CORTICOSTEROIDS AMONG LUPUS PATIENTS WITH INCIDENT END-STAGE RENAL DISEASE (ESRD) ONSET: A LONGITUDINAL STUDY USING USRDS REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1027.2-1027
Author(s):  
A. R. Broder ◽  
W. Mowrey ◽  
A. Valle ◽  
B. Goilav ◽  
K. Yoshida ◽  
...  
Keyword(s):  
United States ◽  
Lupus Nephritis ◽  
Renal Disease ◽  
International Classification Of Diseases ◽  
The United States ◽  
Diagnostic Code ◽  
Prescribing Practices ◽  
Part D ◽  
Stage Renal Disease

Background:The development of ESRD due to lupus nephritis is one of the most common and serious complications of SLE. Mortality among SLE ESRD patients is 4-fold higher compared to lupus nephritis patients with preserved renal function1Mortality in SLE ESRD is also twice as high compared with non-SLE ESRD, even though SLE patients develop ESRD at a significantly younger age. In the absence of ESRD specific guidelines, medication utilization in SLE ESRD is unknown.Objectives:The objective of this study was to investigate the real-world current US-wide patterns of medication prescribing among lupus nephritis patients with new onset ESRD enrolled in the United States Renal Disease Systems (USRDS) registry. We specifically focused on HCQ and corticosteroids (CS) as the most used medications to treat SLE.Methods:Inclusion: USRDS patients 18 years and above with SLE as a primary cause of ESRD (International Classification of Diseases, 9thRevision (ICD9) diagnostic code 710.0, previously validated2). who developed ESRD between January 1st, 2006 and July 31, 2011 (to ensure at least 6 months of follow-up in the USRDS). Patients had to be enrolled in Medicare Part D (to capture pharmacy claims). The last follow-up date was defined as either the last date of continuous part D coverage or the end of the study period, Dec 31, 2013.Results:Of the 2579 patients included, 1708 (66%) were HCQ- at baseline, and 871 (34%) were HCQ+ at baseline. HCQ+ patients at baseline had a slightly lower duration of follow-up compared to HCQ- patients at baseline, median (IQR) of 2.32 (1.33, 3.97) years and 2.55 (1.44, 4.25) years, respectively, p= 0.02. During follow-up period, only 778 (30%) continued HCQ either intermittently or continuously to the last follow-up date, 1306 (51%) were never prescribed HCQ after baseline, and 495 (19%) discontinued HCQ before the last follow-up date. Of the 1801 patients who were either never prescribed or discontinued HCQ early after ESRD onset, 713 (40%) were prescribed CS to the end of the follow-up period: 55% were receiving a low dose <10mg/daily, and 43 were receiving moderate dose (10-20mg daily)Conclusion:HCQ may be underprescribed and CS may be overprescribed in SLE ESRD. Changing the current prescribing practices may improve outcomes in SLE ESRDReferences:[1]Yap DY et al., NDT 2012.[2]Broder A et al., AC&R 2016.Acknowledgments :The data reported here have been supplied by the United States Renal Data System (USRDS). The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy or interpretation of the U.S. government.Funding: :NIH/NIAMS K23 AR068441 (A Broder), NIH/NIAMS R01 AR 057327 and K24 AR 066109 (KH Costenbader)Disclosure of Interests: :Anna R. Broder: None declared, Wenzhu Mowrey: None declared, Anna Valle: None declared, Beatrice Goilav: None declared, Kazuki Yoshida: None declared, Karen Costenbader Grant/research support from: Merck, Consultant of: Astra-Zeneca

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