Browsing by Subject "Point-of-Care Systems"
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Item Open Access Design of a Novel Low Cost Point of Care Tampon (POCkeT) Colposcope for Use in Resource Limited Settings.(PLoS One, 2015) Lam, Christopher T; Krieger, Marlee S; Gallagher, Jennifer E; Asma, Betsy; Muasher, Lisa C; Schmitt, John W; Ramanujam, NimmiINTRODUCTION: Current guidelines by WHO for cervical cancer screening in low- and middle-income countries involves visual inspection with acetic acid (VIA) of the cervix, followed by treatment during the same visit or a subsequent visit with cryotherapy if a suspicious lesion is found. Implementation of these guidelines is hampered by a lack of: trained health workers, reliable technology, and access to screening facilities. A low cost ultra-portable Point of Care Tampon based digital colposcope (POCkeT Colposcope) for use at the community level setting, which has the unique form factor of a tampon, can be inserted into the vagina to capture images of the cervix, which are on par with that of a state of the art colposcope, at a fraction of the cost. A repository of images to be compiled that can be used to empower front line workers to become more effective through virtual dynamic training. By task shifting to the community setting, this technology could potentially provide significantly greater cervical screening access to where the most vulnerable women live. The POCkeT Colposcope's concentric LED ring provides comparable white and green field illumination at a fraction of the electrical power required in commercial colposcopes. Evaluation with standard optical imaging targets to assess the POCkeT Colposcope against the state of the art digital colposcope and other VIAM technologies. RESULTS: Our POCkeT Colposcope has comparable resolving power, color reproduction accuracy, minimal lens distortion, and illumination when compared to commercially available colposcopes. In vitro and pilot in vivo imaging results are promising with our POCkeT Colposcope capturing comparable quality images to commercial systems. CONCLUSION: The POCkeT Colposcope is capable of capturing images suitable for cervical lesion analysis. Our portable low cost system could potentially increase access to cervical cancer screening in limited resource settings through task shifting to community health workers.Item Open Access Does distance modify the effect of self-testing in oral anticoagulation?(The American journal of managed care, 2016-01) Rose, Adam J; Phibbs, Ciaran S; Uyeda, Lauren; Su, Pon; Edson, Robert; Shih, Mei-Chiung; Jacobson, Alan; Matchar, David BObjectives
Patient self-testing (PST) improves anticoagulation control and patient satisfaction. It is unknown whether these effects are more pronounced when the patient lives farther from the anticoagulation clinic (ACC). If the benefits of PST are limited to a subset of patients (those living farther from care), selectively providing PST to that subset could enhance cost-effectiveness.Study design
This is a secondary analysis of a randomized trial of PST versus usual ACC care, which involved 2922 patients of the Veterans Health Administration (VHA).Methods
Our 3 outcomes were the primary composite clinical end point (stroke, major hemorrhage, or death), anticoagulation control (percent time in therapeutic range), and satisfaction with anticoagulation care. We measured the driving distance between the patient's residence and the nearest VHA facility. We divided patients into quartiles by distance and looked for evidence of an interaction between distance and the effect of the intervention on the 3 outcomes.Results
The median driving distance was 12 miles (interquartile range = 6-21). Patients living in the farthest quartile had higher rates of the primary composite clinical end point in both groups compared with patients living in the nearest quartile. For PST, the hazard ratio (HR) was 1.77 (95% CI, 1.18-2.64), and for usual care, the HR was 1.81 (95% CI, 1.19-2.75). Interaction terms did not suggest that distance to care modified the effect of the intervention on any outcome.Conclusions
The benefits of PST were not enhanced among patients living farther from care. Restricting PST to patients living more than a certain distance from the ACC is not likely to improve its cost-effectiveness.Item Open Access Emergency department point-of-care ultrasound in out-of-hospital and in-ED cardiac arrest.(Resuscitation, 2016-12) Gaspari, Romolo; Weekes, Anthony; Adhikari, Srikar; Noble, Vicki E; Nomura, Jason T; Theodoro, Daniel; Woo, Michael; Atkinson, Paul; Blehar, David; Brown, Samuel M; Caffery, Terrell; Douglass, Emily; Fraser, Jacqueline; Haines, Christine; Lam, Samuel; Lanspa, Michael; Lewis, Margaret; Liebmann, Otto; Limkakeng, Alexander; Lopez, Fernando; Platz, Elke; Mendoza, Michelle; Minnigan, Hal; Moore, Christopher; Novik, Joseph; Rang, Louise; Scruggs, Will; Raio, ChristopherPoint-of-care ultrasound has been suggested to improve outcomes from advanced cardiac life support (ACLS), but no large studies have explored how it should be incorporated into ACLS. Our aim was to determine whether cardiac activity on ultrasound during ACLS is associated with improved survival.We conducted a non-randomized, prospective, protocol-driven observational study at 20 hospitals across United States and Canada. Patients presenting with out-of-hospital arrest or in-ED arrest with pulseless electrical activity or asystole were included. An ultrasound was performed at the beginning and end of ACLS. The primary outcome was survival to hospital admission. Secondary outcomes included survival to hospital discharge and return of spontaneous circulation.793 patients were enrolled, 208 (26.2%) survived the initial resuscitation, 114 (14.4%) survived to hospital admission, and 13 (1.6%) survived to hospital discharge. Cardiac activity on US was the variable most associated with survival at all time points. On multivariate regression modeling, cardiac activity was associated with increased survival to hospital admission (OR 3.6, 2.2-5.9) and hospital discharge (OR 5.7, 1.5-21.9). No cardiac activity on US was associated with non-survival, but 0.6% (95% CI 0.3-2.3) survived to discharge. Ultrasound identified findings that responded to non-ACLS interventions. Patients with pericardial effusion and pericardiocentesis demonstrated higher survival rates (15.4%) compared to all others (1.3%).Cardiac activity on ultrasound was the variable most associated with survival following cardiac arrest. Ultrasound during cardiac arrest identifies interventions outside of the standard ACLS algorithm.Item Open Access Fungal infections in HIV/AIDS.(Lancet Infect Dis, 2017-11) Limper, Andrew H; Adenis, Antoine; Le, Thuy; Harrison, Thomas SFungi are major contributors to the opportunistic infections that affect patients with HIV/AIDS. Systemic infections are mainly with Pneumocystis jirovecii (pneumocystosis), Cryptococcus neoformans (cryptococcosis), Histoplasma capsulatum (histoplasmosis), and Talaromyces (Penicillium) marneffei (talaromycosis). The incidence of systemic fungal infections has decreased in people with HIV in high-income countries because of the widespread availability of antiretroviral drugs and early testing for HIV. However, in many areas with high HIV prevalence, patients present to care with advanced HIV infection and with a low CD4 cell count or re-present with persistent low CD4 cell counts because of poor adherence, resistance to antiretroviral drugs, or both. Affordable, rapid point-of-care diagnostic tests (as have been developed for cryptococcosis) are urgently needed for pneumocystosis, talaromycosis, and histoplasmosis. Additionally, antifungal drugs, including amphotericin B, liposomal amphotericin B, and flucytosine, need to be much more widely available. Such measures, together with continued international efforts in education and training in the management of fungal disease, have the potential to improve patient outcomes substantially.Item Open Access International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope.(Journal of lower genital tract disease, 2017-04) Mueller, Jenna L; Asma, Elizabeth; Lam, Christopher T; Krieger, Marlee S; Gallagher, Jennifer E; Erkanli, Alaattin; Hariprasad, Roopa; Malliga, JS; Muasher, Lisa C; Mchome, Bariki; Oneko, Olola; Taylor, Peyton; Venegas, Gino; Wanyoro, Anthony; Mehrotra, Ravi; Schmitt, John W; Ramanujam, NimmiObjective
Barriers to cervical cancer screening in low-resource settings include lack of accessible, high-quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low-cost, intravaginal, optical cervical imaging device, the point-of-care tampon (POCkeT) colposcope and evaluated whether its performance is comparable with a standard-of-care colposcope.Materials and methods
There were 2 protocols, which included 44 and 18 patients. For the first protocol, white-light cervical images were collected in vivo, blinded by device, and sent electronically to 8 physicians from high-, middle-, and low-income countries. For the second protocol, green-light images were also collected and sent electronically to the highest performing physician from the first protocol who has experience in both a high- and low-income country. For each image, physicians completed a survey assessing cervix characteristics and severity of precancerous lesions. Corresponding pathology was obtained for all image pairs.Results
For the first protocol, average percent agreement between devices was 70% across all physicians. The POCkeT and standard-of-care colposcope images had 37% and 51% agreement with pathology for high-grade squamous intraepithelial lesions (HSILs), respectively. Investigation of HSIL POCkeT images revealed decreased visibility of vascularization and lack of contrast in lesion margins. After changes were made for the second protocol, the 2 devices achieved similar agreement to pathology for HSIL lesions (55%).Conclusions
Based on the exploratory study, physician interpretation of cervix images acquired using a portable, low-cost POCkeT colposcope was comparable to a standard-of-care colposcope.Item Open Access Long-Term Impact of an Electronic Health Record-Enabled, Team-Based, and Scalable Population Health Strategy Based on the Chronic Care Model.(AMIA ... Annual Symposium proceedings. AMIA Symposium, 2016-01) Kawamoto, Kensaku; Anstrom, Kevin J; Anderson, John B; Bosworth, Hayden B; Lobach, David F; McAdam-Marx, Carrie; Ferranti, Jeffrey M; Shang, Howard; Yarnall, Kimberly SHThe Chronic Care Model (CCM) is a promising framework for improving population health, but little is known regarding the long-term impact of scalable, informatics-enabled interventions based on this model. To address this challenge, this study evaluated the long-term impact of implementing a scalable, electronic health record (EHR)- enabled, and CCM-based population health program to replace a labor-intensive legacy program in 18 primary care practices. Interventions included point-of-care decision support, quality reporting, team-based care, patient engagement, and provider education. Among 6,768 patients with diabetes receiving care over 4 years, hemoglobin A1c levels remained stable during the 2-year pre-intervention and post-intervention periods (0.03% and 0% increases, respectively), compared to a 0.42% increase expected based on A1c progression observed in the United Kingdom Prospective Diabetes Study long-term outcomes cohort. The results indicate that an EHR-enabled, team- based, and scalable population health strategy based on the CCM may be effective and efficient for managing population health.Item Open Access Microfluidic platform versus conventional real-time polymerase chain reaction for the detection of Mycoplasma pneumoniae in respiratory specimens.(Diagn Microbiol Infect Dis, 2010-05) Wulff-Burchfield, Elizabeth; Schell, Wiley A; Eckhardt, Allen E; Pollack, Michael G; Hua, Zhishan; Rouse, Jeremy L; Pamula, Vamsee K; Srinivasan, Vijay; Benton, Jonathan L; Alexander, Barbara D; Wilfret, David A; Kraft, Monica; Cairns, Charles B; Perfect, John R; Mitchell, Thomas GRapid, accurate diagnosis of community-acquired pneumonia (CAP) due to Mycoplasma pneumoniae is compromised by low sensitivity of culture and serology. Polymerase chain reaction (PCR) has emerged as a sensitive method to detect M. pneumoniae DNA in clinical specimens. However, conventional real-time PCR is not cost-effective for routine or outpatient implementation. Here, we evaluate a novel microfluidic real-time PCR platform (Advanced Liquid Logic, Research Triangle Park, NC) that is rapid, portable, and fully automated. We enrolled patients with CAP and extracted DNA from nasopharyngeal wash (NPW) specimens using a biotinylated capture probe and streptavidin-coupled magnetic beads. Each extract was tested for M. pneumoniae-specific DNA by real-time PCR on both conventional and microfluidic platforms using Taqman probe and primers. Three of 59 (5.0%) NPWs were positive, and agreement between the methods was 98%. The microfluidic platform was equally sensitive but 3 times faster and offers an inexpensive and convenient diagnostic test for microbial DNA.Item Open Access Point-of-care diagnosis of invasive aspergillosis in non-neutropenic patients: Aspergillus Galactomannan Lateral Flow Assay versus Aspergillus-specific Lateral Flow Device test in bronchoalveolar lavage.(Mycoses, 2019-03) Jenks, Jeffrey D; Mehta, Sanjay R; Taplitz, Randy; Aslam, Saima; Reed, Sharon L; Hoenigl, MartinBackground
We compared new Aspergillus Galactomannan Lateral Flow Assay with the newly formatted Aspergillus-specific Lateral Flow device tests for the diagnosis of invasive pulmonary aspergillosis (IPA) in non-neutropenic patients.Methods
We performed both tests in 82 bronchoalveolar lavage fluid samples from 82 patients at risk for IPA but without underlying haematologic malignancy. Samples were collected between September 2016 and September 2018 at the University of California San Diego, United States. IPA was classified following two published consensus criteria.Results
Classification of cases varied widely between the two consensus criteria. When using criteria established for the intensive care unit, 26/82 patients (32%) met criteria for proven or putative IPA. Both point-of-care assays showed sensitivities ranging between 58% and 69%, with specificities between 68% and 75%. Sensitivity increased up to 81% when both tests were combined.Conclusion
The study outlines the need for updated, unified and more broadly applicable consensus definitions for classifying IPA in non-neutropenic patients, a work that is currently in progress. Both point-of-care tests showed comparable performance, with sensitivities and specificities in the 60%-70% range when used alone and increasing to 80% when used in combination. The new point-of-care tests may serve a role at the bedside in those with clinical suspicion of IPA.Item Open Access Point-of-Care Laboratory Data Collection During Critical Care Transport.(Air medical journal, 2021-01) Eastman, Jamie; Allen, Deborah; Mumma, Kevin; Almond, Andrew; Theiling, JasonObjective
Critical care transport involves a high level of intensive clinical care in a resource-limited environment. These patients require multiple assessments guiding specialty treatments, including blood product administration, intravenous electrolyte replacement, ventilator management, and extracorporeal membrane oxygenation. This study aims to measure the usage of point-of-care (POC) laboratory data during critical care transport.Methods
Data were collected via electronic medical record review over 1 year of use in a hospital-based critical care rotor wing, fixed wing, and ground critical care transport team in the Southeastern United States.Results
One hundred twenty POC tests were performed during 1,075 critical care transports over the 1-year period (8.9%). Patient transportations involved 35 extracorporeal membrane oxygenation, 21 medical, 17 cardiac, 13 neonatal, 11 respiratory failure, 8 gastrointestinal bleeding, 6 neurologic, 5 pediatrics, 3 trauma, and 1 organ donor. Seventy-eight POC laboratory tests (65%) required intervention, including ventilator changes (39.7%), electrolyte replacement (35.8%), blood products (7.6%), and other (12.8%). The remaining 42 (35%) POC laboratory tests confirmed no intervention was necessary (n = 35) and that ongoing treatments were effective (n = 7).Conclusion
POC laboratory testing performed during critical care transport guides providers in performing essential emergent interventions in a timelier manner that may benefit critically ill patients.Item Open Access Portable Pocket colposcopy performs comparably to standard-of-care clinical colposcopy using acetic acid and Lugol's iodine as contrast mediators: an investigational study in Peru.(BJOG : an international journal of obstetrics and gynaecology, 2018-09) Mueller, JL; Lam, CT; Dahl, D; Asiedu, MN; Krieger, MS; Bellido-Fuentes, Y; Kellish, M; Peters, J; Erkanli, A; Ortiz, EJ; Muasher, LC; Taylor, PT; Schmitt, JW; Venegas, G; Ramanujam, NObjective
Our goal was to develop a tele-colposcopy platform for primary-care clinics to improve screening sensitivity and access. Specifically, we developed a low-cost, portable Pocket colposcope and evaluated its performance in a tertiary healthcare centre in Peru.Design and setting
Images of the cervix were captured with a standard-of-care and Pocket colposcope at la Liga Contra el Cáncer in Lima, Peru.Population
Two hundred Peruvian women with abnormal cytology and/or human papillomavirus positivity were enrolled.Methods
Images were collected using acetic acid and Lugol's iodine as contrast agents. Biopsies were taken as per standard-of-care procedures.Main outcome measures
After passing quality review, images from 129 women were sent to four physicians who provided a diagnosis for each image.Results
Physician interpretation of images from the two colposcopes agreed 83.1% of the time. The average sensitivity and specificity of physician interpretation compared with pathology was similar for the Pocket (sensitivity = 71.2%, specificity = 57.5%) and standard-of-care (sensitivity = 79.8%, specificity = 56.6%) colposcopes. When compared with a previous study where only acetic acid was applied to the cervix, results indicated that adding Lugol's iodine as a secondary contrast agent improved the percent agreement between colposcopes for all pathological categories by up to 8.9% and the sensitivity and specificity of physician interpretation compared with pathology by over 6.0 and 9.0%, respectively.Conclusions
The Pocket colposcope performance was similar to that of a standard-of-care colposcope when used to identify precancerous and cancerous lesions using acetic acid and Lugol's iodine during colposcopy examinations in Peru.Tweetable abstract
The Pocket colposcope performance was similar to that of a standard-of-care colposcope when identifying cervical lesions.Item Open Access The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation.(Eur Heart J, 2015-12-07) O'Brien, Emily C; Simon, DaJuanicia N; Thomas, Laine E; Hylek, Elaine M; Gersh, Bernard J; Ansell, Jack E; Kowey, Peter R; Mahaffey, Kenneth W; Chang, Paul; Fonarow, Gregg C; Pencina, Michael J; Piccini, Jonathan P; Peterson, Eric DBACKGROUND: Therapeutic decisions in atrial fibrillation (AF) are often influenced by assessment of bleeding risk. However, existing bleeding risk scores have limitations. OBJECTIVES: We sought to develop and validate a novel bleeding risk score using routinely available clinical information to predict major bleeding in a large, community-based AF population. METHODS: We analysed data from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), a prospective registry that enrolled incident and prevalent AF patients at 176 US sites. Using Cox proportional hazards regression, we identified factors independently associated with major bleeding among patients taking oral anticoagulation (OAC) over a median follow-up of 2 years (interquartile range = 1.6-2.5). We also created a numerical bedside risk score that included the five most predictive risk factors weighted according to their strength of association with major bleeding. The predictive performance of the full model, the simple five-item score, and two existing risk scores (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile INR, elderly, drugs/alcohol concomitantly, HAS-BLED, and anticoagulation and risk factors in atrial fibrillation, ATRIA) were then assessed in both the ORBIT-AF cohort and a separate clinical trial population, Rivaroxaban Once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET-AF). RESULTS: Among 7411 ORBIT-AF patients taking OAC, the rate of major bleeding was 4.0/100 person-years. The full continuous model (12 variables) and five-factor ORBIT risk score (older age [75+ years], reduced haemoglobin/haematocrit/history of anaemia, bleeding history, insufficient kidney function, and treatment with antiplatelet) both had good ability to identify those who bled vs. not (C-index 0.69 and 0.67, respectively). These scores both had similar discrimination, but markedly better calibration when compared with the HAS-BLED and ATRIA scores in an external validation population from the ROCKET-AF trial. CONCLUSIONS: The five-element ORBIT bleeding risk score had better ability to predict major bleeding in AF patients when compared with HAS-BLED and ATRIA risk scores. The ORBIT risk score can provide a simple, easily remembered tool to support clinical decision making.