Standard Monitoring Of Patients Research Articles

Quantitative comparison of automated OCT and conventional FAF-based geographic atrophy measurements in the phase 3 OAKS/DERBY trials

With the approval of the first two substances for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a standardized monitoring of patients treated with complement inhibitors in clinical practice is needed. Optical coherence tomography (OCT) provides high-resolution access to the retinal pigment epithelium (RPE) and neurosensory layers, such as the ellipsoid zone (EZ), which further enhances the understanding of disease progression and therapeutic effects in GA compared to conventional fundus autofluorescence (FAF). In addition, artificial intelligence-based methodology allows the identification and quantification of GA-related pathology on OCT in an objective and standardized manner. The purpose of this study was to comprehensively evaluate automated OCT monitoring for GA compared to reading center-based manual FAF measurements in the largest successful phase 3 clinical trial data of complement inhibitor therapy to date. Automated OCT analysis of RPE loss showed a high and consistent correlation to manual GA measurements on conventional FAF. EZ loss on OCT was generally larger than areas of RPE loss, supporting the hypothesis that EZ loss exceeds underlying RPE loss as a fundamental pathophysiology in GA progression. Automated OCT analysis is well suited to monitor disease progression in GA patients treated in clinical practice and clinical trials.

388 Prototyping a mobile phone application for Chimeric Antigen Receptor (CAR) T-cell therapy patient monitoring and data collection post-discharge

OBJECTIVES/GOALS: Research objectives include prototyping a mobile phone application that allows physicians to monitor CD19-directed CAR T-cell therapy patients remotely after discharge. This app will also enable standardized data collection across different centers that provide CAR-T cell therapy and allow for the harmonization of follow-up protocols. METHODS/STUDY POPULATION: Literature review and semi-structured interviews with patients, clinical coordinators, and other experts in the field will be used to determine what parameters must be included in the mobile application prototype to effectively monitor the side effects of CD19-directed CAR T-cell therapy. The mobile phone application will be designed using process mapping to integrate data from self-reporting and wearable technologies, including the Garmin smart watch. Figma will then be used to develop new screens based on an existing patient monitoring app for Allogeneic Stem Cell Transplant follow-up. Finally, a preliminary feasibility study will be conducted to collect feedback on the app prototype from CAR T-cell therapy patients, providers, and stakeholders. RESULTS/ANTICIPATED RESULTS: The anticipated results of this study include an app prototype that will include the functionalities required to monitor patients for adverse effects of CD19-directed CAR T-cell therapy. This will include the parameters that will be recorded or measured using a combination of self-reporting, a reliable body temperature sensor, and the Garmin watch which monitors basic vitals, activity, and sleep. Additional parameters may be added during the stakeholder co-design process. The app prototype will include a physician interface where doctors can monitor their patients and will be alerted if they require further physician assessment. It is expected that the app will provide standardized monitoring of patients when they are discharged from the hospital after receiving CAR T-cell therapy. DISCUSSION/SIGNIFICANCE: This app will allow physicians to monitor patients for general follow-up and adverse effects, including cytokine release syndrome and neurotoxicity. Future studies may utilize this app to develop best practices for harmonizing CAR-T follow-up protocols across Canada.

Validation of the developed ASGARD risk score for safe monitoring of asymptomatic patients with non-severe aortic valve stenosis

Abstract Background The recommended standard monitoring of patients with non-severe aortic valve stenosis (AS) involves echocardiography surveillance at 1-2 year intervals. Since many of these costly routine echocardiograms yield no clinical consequences during a prolonged watchful waiting period, we propose to replace them with a risk stratification approach. Purpose The primary aim was to validate the ability of ASGARD risk score to a) identify low-risk AS patients who do not need new echocardiography for safe monitoring, and b) estimate optimal follow-up intervals. Methods We have developed the ASGARD risk score using data from 1196/1739 (69%) asymptomatic AS-patients with mild-to-moderate AS who were enrolled in the randomized, multicentre Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. The primary outcome was a composite of AS-related outcomes, aortic valve replacement, or hospitalization with heart failure during a clinically relevant 2-year follow-up. From multivariable Cox proportional hazards regression analyses, we chose the best prognostic model with the lowest Akaike information criterion (AIC) values and p-values <0.05. The risk score included five predictors: age, sex, systolic blood pressure, N-terminal pro-brain natriuretic peptide (NT-proBNP), and last year's measurement of transaortic maximal velocity (Vmax). Kaplan-Meier plot visualized event rates stratified by quartiles of risk score. We validated the ASGARD risk score in an internal validation cohort of 543 patients (31% hold-out from SEAS-population) and an external validation cohort of 69 asymptomatic out-clinic patients with Vmax ≤4 m/s from six hospitals from capital city. Results Patients from the external validation cohort significantly differed from those in the development cohort in terms of higher age (mean [SD], 71.7 [8.5] vs. 67.4 [9.8] years, p<0.001), less prevalent left ventricular hypertrophy (13.0% vs. 37.5%, p<0.001), and higher event-rates (12.5 [95% CI, 7.6-20.8] vs. 4.5 [3.7-5.4] events per 100 patient-years of follow-up, p<0.001). The ASGARD risk score showed consistent predictive performance across the validation cohorts (external validation: area under the curve: 0.82 [95% CI, 0.73-0.91]; calibration-in-the-large, p=0.24; calibration slope, p=0.15; Brier score, 0.18). The score performed just as well or better than a new Vmax measurement (Figure 1A-1B). In the three upper ASGARD score quartiles, 95% of patients had less than 5% risk of AVR or heart failure until 7.5, 16.5, and 22.5 months, respectively (Figure 1C). Conclusion Without a new echocardiogram, the ASGARD risk score identifies patients at low risk for AS-related events among asymptomatic patients with non-severe AS. The ASGARD risk score also estimates the safe watchful-waiting period of 6, 15, 21, and 24 months for the four ASGARD risk score quartiles in decreasing order.Figure 1

Retrospective cohort analysis of the safety of outpatient parenteral antimicrobial therapy (OPAT) in an academic hospital

Background: Although many infectious conditions can be safely treated with oral antimicrobials, select circumstances require parenteral antimicrobial therapy. Benefits of OPAT include prevention of hospital-associated conditions and significant cost savings. However, risks of OPAT include adverse drug events (ADEs) and vascular access device (VAD) complications. We analyzed the safety of OPAT regimens as part of implementing a collaborative OPAT program. Methods: We reviewed adult patients discharged home from an academic hospital between January 2019 and June 2021. Patients with cystic fibrosis were excluded. Data on OPAT agents, ADEs, and VAD complications were collected from electronic medical records by 2 reviewers using a standardized REDCap instrument. The institutional review board approved this study. Results: The cohort comprised 265 unique patients; 212 (80%) received single-drug therapy and 53 (20%) received multidrug therapy. In total, 81 patients (31%), who received a total of 110 antimicrobials, experienced an ADE. In total, 55 patients (21%), who received a total of 72 antimicrobials, experienced a VAD complication. Patients who received >1 antimicrobial were more likely to experience an ADE (53% vs 25%; P = .0002) or a VAD complication (32% vs 18%; P = .04). Cephalosporins were the most frequently prescribed antimicrobial class (Table 1). Conclusions: ADEs and VAD complications were frequent in patients on OPAT. Local data should inform (1) the selection of OPAT therapy and (2) the standardized monitoring of patients who receive OPAT going forward in the implementation of this collaborative OPAT program.Funding: NoneDisclosures: None

Accuracy of vital parameters measured by a wearable patch following major abdominal cancer surgery

IntroductionRecent advances in wearable technology allow for the development of wirelessly connected sensors to continuously measure vital parameters in the general ward or even at home. The present study assesses the accuracy of a wearable patch (Healthdot) for continuous monitoring of heartrate (HR) and respiration rate (RR). Materials and methodsThe Healthdot measures HR and RR by means of chest accelerometry. The study population consisted of patients following major abdominal oncological surgery. The analysis focused on the agreement between HR and RR measured by the Healthdot and the gold standard patient monitor in the intensive and post-anesthesia care unit. ResultsFor HR, a total of 112 h of measurements was collected in 26 patients. For RR, a total of 102 h of measurements was collected in 21 patients. On second to second analysis, 97% of the HR and 87% of the RR measurements were within 5 bpm and 3 rpm of the reference monitor. Assessment of 5-min averaged data resulted in 96% of the HR and 95% of the RR measurements within 5 bpm and 3 rpm of the reference monitor. A Clarke error grid analysis showed that 100% of the HR and 99.4% of the 5-min averaged data was clinically acceptable. ConclusionThe Healthdot accurately measured HR and RR in a cohort of patients recovering from major abdominal surgery, provided that good quality data was obtained. These results push the Healthdot forward as a clinically acceptable tool in low acuity settings for unobtrusive, automatic, wireless and continuous monitoring.

Comparison of Telehomecare Interventions in Controlling Chronic Obstructive Pulmonary Disease (COPD): Protocol for a Systematic Review and Meta-analysis

Background: Chronic obstructive pulmonary disease (COPD) is considered the fourth main cause of mortality worldwide, affecting 10% of adults aged up to 40 years. Due to the growing elderly population and smoking, the global burden of COPD is expected to increase in the general population. Telemedicine may help patients with COPD to decrease exacerbation episodes and the associated costs. Moreover, Telehomecare (THC) may be considered as an alternative to cut down hospitalization costs and increase the patients’ comfort.
 Objectives: This study explains the methodology of a systematic review and meta-analysis designed to evaluate the impact of THC interventions on the control and management of COPD and its complications.
 Methods: To review all published studies comparing THC interventions in controlling COPD and its complications, all studies published in PubMed, Google Scholar, Scopus, ISI Web of Science, Cochrane databases, HTA EED, DARE, Embase, SID, Magiran will be searched until the end of 2021. Randomized controlled trials (RCTs), cluster RCTs, controlled clinical trials comparing telehealth with standard monitoring of COPD patients were included. Independent reviewers will review the abstracts and full-texts of all relevant studies for eligibility, risk of bias, and data extraction using structured forms. The meta-analysis will be performed for adequately homogenous studies regarding their populations, interventions, and objectives.
 Conclusion: The results of this systematic review and meta-analysis will provide useful information on the impacts of THC on COPD control. The evidence provided by this systematic review can be helpful for clinical specialists, public health policymakers, and the general population.

REG3α is a novel biomarker that potentially correlates with acute allograft rejection after intestinal transplantation.

Monitoring of intestinal allograft function remains a challenge. While frequent endoscopies and biopsies are the gold standard, no single biomarker exists to screen for intestinal transplant rejection. The novel REG3α, an antimicrobial peptide secreted by intestinal enterocytes and Paneth cells, has been associated with inflammatory bowel disease as well as intestinal graft versus host disease. Our aim was to identify and describe a role of REG3α in monitoring or predicting acute allograft rejection after intestinal transplantation (ITx). Since 2019, we have incorporated REG3α into the standard monitoring of patients after ITx. We conducted a retrospective analysis of a prospectively maintained IRB-approved database and present, herein, the results of 2 adults with irreversible intestinal failure who underwent isolated ITx under this monitoring protocol. Increases in REG3α corresponded with acute allograft rejection in both cases and preceded acute allograft rejection by 1week in one of the cases. We describe REG3α as a non-invasive marker of acute allograft rejection after adult isolated ITx which not only corresponded with acute allograft rejection but also preceded histopathological changes by 1week.

P283 Decrease in bowel wall thickness at intestinal ultrasound accurately detects early endoscopic remission and improvement in ulcerative colitis patients on tofacitinib: a longitudinal prospective cohort study

Abstract Background To assess disease activity in ulcerative colitis (UC) intestinal ultrasound (IUS) highly correlates with endoscopic outcomes. However, data on treatment response evaluated with IUS is limited. In this study we aim to evaluate bowel wall thickness (BWT) at follow-up to determine treatment effectiveness in moderate-severe UC patients treated with tofacitinib according to central read endoscopy and histology. Methods Patients with moderate-severe UC (endoscopic Mayo score (EMS)≥2) starting tofacitinib 10 mg bid were included. Disease activity was evaluated by recorded IUS cine-loops and video-taped endoscopies with biopsies from the sigmoid (SC) and descending colon (DC) at baseline and at 8 weeks. BWT and EMS were assessed per segment (SC and DC). Histology was scored for the SC with the Robarts Histology Index (RHI). BWT, EMS and RHI were centrally read and for IUS there was a second reader. Endoscopic remission (ERem) was defined as EMS=0, endoscopic improvement (EI) as EMS≤1 and endoscopic response (ERes) as a decrease of EMS≥1. For statistical analysis a Wilcoxon signed-rank and Spearman’s test were used. Area under the ROC was used to determine optimal cut-off values. Inter-observer agreement was analyzed by intra-class correlation coefficient (ICC). Results 29 patients were included and started tofacitinib. 10% reached complete ERem after 8 weeks, respectively. Per-segment analysis for EMS showed 22% and 53% reaching ER and 40% and 60% having EI in the SC and DC, respectively. BWT in SC and DC correlated highly with the EMS (rho=0.68, rho=0.75, both p<0.0001) and moderately with RHI (rho=0.49, p=0.002). Patients with EMS≥2 after 8 weeks had an increased BWT (SC: 4.32 ± 1.57 mm, DC: 4.38 ± 1.58 mm) when compared to ERem (SC: 2.10 ± 0.67 mm, DC: mean: 2.00 ± 1.18 mm, both p<0.0001) and EI (SC: 2.29 ± 0.76 mm, DC: 2.56 ± 1.38 mm, both p<0.0001) in the similar segment (Figure 1 and 2). BWT decreased after 8 weeks when there was ERes (SC: mean: -2.59 ± 1.44 mm, DC: -1.82 ± 1.01 mm, both p=0.007) and did not when there was no ERes (Figure 3). BWT cut-off values for ERem are reported in Figure 4. Furthermore, agreement for BWT in the SC and DC was excellent (ICC: 0.92 and ICC: 0.89), respectively. Conclusion BWT reduction showed early endoscopic remission, improvement and response after 8 weeks of tofacitinib treatment and correlated with histology in this central read cohort. Furthermore, accurate and reliable cut-off values for BWT in SC and DC were found for endoscopic remission and improvement. Therefore, IUS should be incorporated in the standard follow-up and close monitoring of UC patients.

Controlling Anesthesia Hardware With Simple Hand Gestures: Thumbs Up or Thumbs Down?

Modern consumer electronic devices and automobiles are often controlled by interfaces that sense physical gestures and spoken commands. In contrast, patient monitors and anesthesia devices are typically equipped with panel-mounted buttons, dials, and keyboards. The increased use of noncontact gesture-based interfaces in anesthesia may improve patient safety through more intuitive and prompter control of equipment and also through reduced rates of surface contamination. A novel gesture-based controller was designed and retrofitted to a standard GE Solar 8000M patient monitor. This type of technical innovation is rare, due to closely held proprietary input control systems on commercially produced clinical equipment. Nevertheless, we hypothesized that anesthesiologists would find a contactless gesture interface straightforward to use. A gesture-based interface system was developed to control a Solar 8000M patient monitor using a millimeter-wave radar sensor. The system was programmed to detect noncontact "rotate" and "press" gestures to control the patient monitor by implementing a virtual trim knob for interface control. Fifty anesthesiologists tested a prototype interface and evaluated usability by completing a short questionnaire incorporating modified Likert scales. These evaluations were performed in a nonpatient care environment so that respondents were not adversely task loaded during assessment, also allaying any ethical or safety concerns regarding use of this novel interface for patient management. Anesthesia hardware was controlled reliably with 2 distinct gestures above the gesture sensor. The gesture-based interface generally was well received by anesthesiologists (8.09; confidence interval, 8.06-8.12 on a 10-point scale), who preferred the simpler "press" gesture to the "rotate" gesture (8.45; 8.39-8.51 vs 7.73; 7.67-7.79 on a 10-point scale; P = .005). The correlation between the preference scores for the 2 gestures from each anesthesiologist was strong (Pearson r = 0.49; 0.25-0.68; P < .001). Advancing level of training (resident, fellow, attending 1-10 years, attending >10 years) was not correlated with preference scores for either gesture (Spearman ρ = -0.02; -0.30 to 0.26; P = .87 for "press" and Spearman ρ = 0.08; -0.20 to 0.35; P = .58 for "rotate"). The use of gesture sensing for controlling anesthesia equipment was well received by a cohort of anesthesiologists. Even though the simpler "press" gesture was preferred over the "rotate" gesture, the intrarespondent correlation indicates that the preference for gestures as a whole is the stronger effect. No adverse relationship was found between acceptability and anesthesia experience level. Gesture sensing is a promising new area to simplify and improve the interaction between the anesthesiologist and the anesthesia workstation.

The ISCCA flow protocol for the monitoring of anti-CD20 therapies in autoimmune disorders.

Anti-CD20 monoclonals (MoAbs) are used in a variety of autoimmune disorders. The aim is to eliminate memory B cells sustaining the tissue damage and the production of pathogenic autoantibodies, while preserving naïve cells. The disappearance of memory B cells and the repopulation by naïve cells correlate with good clinical response, while the reappearance of memory B cells and plasmablasts correlates with relapse or resistance to therapy. Anti-CD20 induce extremely low B cell levels, requiring high-resolution techniques. The immune monitoring protocol developed by ISCCA is described and validated, to provide a standardized method for the clinical decision-making process during anti-CD20 therapies in autoimmune diseases. A 10-marker, 8-color staining panel (CD20-V450, CD45-V500c, CD4-FITC + sIgM-FITC, CD38-PE, CD3-PerCP Cy5.5, CD19-PE-Cy7, CD27-APC, CD8-APC H7 + sIgG-APC-H7) is used to identify B cells, plasma cells/blasts, naïve and memory B cells, sIgM+ and sIgG-switched memory B cells, T and NK cells, with high-sensitivity analysis (>106 CD45+ cells). After an anti-CD20 dose, the B cell level is about zero in most patients. If B cells remain virtually absent (<0.1/μl), subsetting is not reliable nor meaningful. If B cells raise >0.3-0.5/μl, subsetting is possible and informative, acquiring >1.0-1.5 × 106 CD45+ events. Further testings can follow the quality of B cell repopulation. If B cells become detectable (>1/μl), the prevalence of memory B cells indicates non-responsiveness or a possible relapse. The ISCCA Protocol is proposed for a standardized prospective monitoring of patients with autoimmune disorders, to assist the safe and rational usage of anti-CD20 therapies.

Comparing Classroom Instruction to Individual Instruction as an Approach to Teach Avatar-Based Patient Monitoring With Visual Patient: Simulation Study.

BackgroundVisual Patient is an avatar-based alternative to standard patient monitor displays that significantly improves the perception of vital signs. Implementation of this technology in larger organizations would require it to be teachable by brief class instruction to large groups of professionals. Therefore, our study aimed to investigate the efficacy of such a large-scale introduction to Visual Patient.ObjectiveIn this study, we aimed to compare 2 different educational methods, one-on-one instruction and class instruction, for training anesthesia providers in avatar-based patient monitoring.MethodsWe presented 42 anesthesia providers with 30 minutes of class instruction on Visual Patient (class instruction group). We further selected a historical sample of 16 participants from a previous study who each received individual instruction (individual instruction group). After the instruction, the participants were shown monitors with either conventional displays or Visual Patient displays and were asked to interpret vital signs. In the class instruction group, the participants were shown scenarios for either 3 or 10 seconds, and the numbers of correct perceptions with each technology were compared. Then, the teaching efficacy of the class instruction was compared with that of the individual instruction in the historical sample by 2-way mixed analysis of variance and mixed regression.ResultsIn the class instruction group, when participants were presented with the 3-second scenario, there was a statistically significant median increase in the number of perceived vital signs when the participants were shown the Visual Patient compared to when they were shown the conventional display (3 vital signs, P<.001; effect size –0.55). No significant difference was found for the 10-second scenarios. There was a statistically significant interaction between the teaching intervention and display technology in the number of perceived vital signs (P=.04; partial η2=.076). The mixed logistic regression model for correct vital sign perception yielded an odds ratio (OR) of 1.88 (95% CI 1.41-2.52; P<.001) for individual instruction compared to class instruction as well as an OR of 3.03 (95% CI 2.50-3.70; P<.001) for the Visual Patient compared to conventional monitoring.ConclusionsAlthough individual instruction on Visual Patient is slightly more effective, class instruction is a viable teaching method; thus, large-scale introduction of health care providers to this novel technology is feasible.

783. Characterization of Non-tuberculous Mycobacteria Isolates in a National Mycobacterial Laboratory in Panama: 2012–2015

BackgroundNontuberculous mycobacteria (NTM) are becoming more frequently isolated in microbiology laboratories. There is no standardized diagnosis, treatment, and/or monitoring of patients with NTM disease. We described the experience of the Panama National Mycobacterial Laboratory in isolating NTM in patients suspected to have active tuberculosis in Panama.MethodsData registries of the National TB Program Laboratory of Panama between 2012 and 2015 were reviewed. Demographic information, relevant history, sample source, and isolate identified for each specimen obtained at the time of specimen submission was extracted. Identification of mycobacterial species were made using culture and PCR. Data were exported to an Excel workbook and a descriptive analysis was performed using STATA.ResultsA total of 4,545 samples were received during this period. Of these, 288 (6.3%) were not processed. From the remaining 4,257 samples, 705 (16.5%) were negative, 2,783 (65.3%) were positive for M. tuberculosis, and 769 (18%) were confirmed NTM. NTM species identification was achieved in 715 (93%) using PCR. Median age was 55 years (0 – 92); 49.4% were male. The most frequent NTM isolate was M. avium complex in 172 (22.3%) samples, followed by M. fortuitum in 131 (17%). M. chelonae was isolated in 98 (12.7%) samples, M. gordonae in 50 (6.5%), M. scrofulaceum in 20 (2.6%), and M. triviale in 16 (2.0%). NTM isolation steadily rose over the study period with 490 (63.7%) of the samples being from 2015 and 465 (94.5%) of these typified by PCR. Specimens mainly originated from the Panama metropolitan area (88.2%) and were mostly sputum samples (70.8%).ConclusionNontuberculous mycobacteria represented an important proportion of isolates among TB suspects in Panama. The implementation of more sensitive diagnostic techniques is increasing the recovery of NTM. Further evaluation of the clinical significance of these finding is required for appropriate guideline implementation.Disclosures G. Henostroza, Aeras: Investigator, Grant recipient.

Ten years of follow-up data in psoriatic arthritis: results based on standardized monitoring of patients in an ordinary outpatient clinic in southern Norway

BackgroundOver the last decade, a treat-to-target (T2T) strategy has been recommended for psoriatic arthritis (PsA) and new treatment options have become available. There is a lack of data on PsA regarding any changes that may have occurred over these past years. Thus, the main aim of this study was to look for changes in clinical disease status and treatment in a PsA outpatient clinic population monitored over the period 2008 to 2017.MethodsAnnual data collection included demographic data, laboratory (erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)) and clinic measures of disease activity (e.g., 28 and 32 joint count Disease Activity Score (DAS28), Clinical Disease Activity Index (CDAI), and modified Disease Activity index for Psoriatic arthritis (DAPSA)), evaluator’s global assessment, and patient-reported outcomes (PROs), including for example measures of physical function, pain, and patient global assessment. Disease-modifying antirheumatic drug (DMARD) use was also registered.ResultsIn the PsA outpatient clinic population over the 10-year period (annual mean number of patients, 331) the mean (standard deviation) age was 58.4 (12.4) years, disease duration was 9.6 (7.9) years, 49.4% were female, and 17.6% were current smokers. From 2008 to 2017, no statistically significant increase in remission rates was seen for DAPSA (13.5% and 22.0%) or Boolean remission (6.6% and 8.9%), whereas a statistically significant increase was seen for DAS28-ESR (36.8% and 50.6%) and CDAI (20.0% and 29.6%), but not for the last 5 years (DAS28-ESR, 42.3% and 50.6%; CDAI, 27.9% and 29.6%). Furthermore, over the 10-year period no significant improvement for PROs and no significant change in the use of synthetic (annual mean 53.0%) and biologic DMARDs (annual mean 29.9%) was found.ConclusionOur data suggest that even in the biologic treatment era there is an unmet need for treating PsA patients to target remission. New treatment options and the development of more feasible and valid outcome measures for use in a T2T strategy in ordinary clinical practice may in the future to further improve clinical outcomes in PsA.

Determination of saturation, heart rate, and respiratory rate at forearm using a Nellcor™ forehead SpO2-saturation sensor.

Alterations in arterial blood oxygen saturation, heart rate (HR), and respiratory rate (RR) are strongly associated with intra-hospital cardiac arrests and resuscitations. A wireless, easy-to-use, and comfortable method for monitoring these important clinical signs would be highly useful. We investigated whether the Nellcor™ OxiMask MAX-FAST forehead sensor could provide data for vital sign measurements when located at the distal forearm instead of its intended location at the forehead to provide improved comfortability and easy placement. In a prospective setting, we recruited 30 patients undergoing surgery requiring postoperative care. At the postoperative care unit, patients were monitored for two hours using a standard patient monitor and with a study device equipped with a Nellcor™ Forehead SpO2 sensor. The readings were electronically recorded and compared in post hoc analysis using Bland-Altman plots, Spearman's correlation, and root-mean-square error (RMSE). Bland-Altman plot showed that saturation (SpO2) differed by a mean of -0.2% points (SD, 4.6), with a patient-weighted Spearman's correlation (r) of 0.142, and an RMSE of 4.2 points. For HR measurements, the mean difference was 0.6bpm (SD, 2.5), r=0.997, and RMSE=1.8. For RR, the mean difference was -0.5 1/min (4.1), r=0.586, and RMSE=4.0. The SpO2 readings showed a low mean difference, but also a low correlation and high RMSE, indicating that the Nellcor™ saturation sensor cannot reliably assess oxygen saturation at the forearm when compared to finger PPG measurements.

How to Monitor Patients Receiving Direct Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Practice Tool Endorsed by Thrombosis Canada, the Canadian Stroke Consortium, the Canadian Cardiovascular Pharmacists Network, and the Canadian Cardiovascular Society

Ideas and Opinions1 September 2015How to Monitor Patients Receiving Direct Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Practice Tool Endorsed by Thrombosis Canada, the Canadian Stroke Consortium, the Canadian Cardiovascular Pharmacists Network, and the Canadian Cardiovascular SocietyDavid J. Gladstone, MD, PhD, William H. Geerts, MD, James Douketis, MD, Noah Ivers, MD, PhD, Jeff S. Healey, MD, and Kori Leblanc, PharmDDavid J. Gladstone, MD, PhDFrom the University of Toronto Department of Medicine; Sunnybrook Regional Stroke Prevention Clinic, Hurvitz Brain Sciences Program, Dr. Thomas and Harriet Black Rapid TIA Clinic, and Anticoagulant Management Clinic and Thromboembolism Service, Sunnybrook Health Sciences Centre; University of Toronto Stroke Program; Family Practice Health Centre, Women's College Research Institute, and Institute for Health Systems Solutions and Virtual Care, Women's College Hospital;and University Health Network and OpenLab, University Health Network, Toronto, Ontario, Canada, and McMaster University, Population Health Research Institute, and Canadian Stroke Prevention Intervention Network, Hamilton, Ontario, Canada.Search for more papers by this author, William H. Geerts, MDFrom the University of Toronto Department of Medicine; Sunnybrook Regional Stroke Prevention Clinic, Hurvitz Brain Sciences Program, Dr. Thomas and Harriet Black Rapid TIA Clinic, and Anticoagulant Management Clinic and Thromboembolism Service, Sunnybrook Health Sciences Centre; University of Toronto Stroke Program; Family Practice Health Centre, Women's College Research Institute, and Institute for Health Systems Solutions and Virtual Care, Women's College Hospital;and University Health Network and OpenLab, University Health Network, Toronto, Ontario, Canada, and McMaster University, Population Health Research Institute, and Canadian Stroke Prevention Intervention Network, Hamilton, Ontario, Canada.Search for more papers by this author, James Douketis, MDFrom the University of Toronto Department of Medicine; Sunnybrook Regional Stroke Prevention Clinic, Hurvitz Brain Sciences Program, Dr. Thomas and Harriet Black Rapid TIA Clinic, and Anticoagulant Management Clinic and Thromboembolism Service, Sunnybrook Health Sciences Centre; University of Toronto Stroke Program; Family Practice Health Centre, Women's College Research Institute, and Institute for Health Systems Solutions and Virtual Care, Women's College Hospital;and University Health Network and OpenLab, University Health Network, Toronto, Ontario, Canada, and McMaster University, Population Health Research Institute, and Canadian Stroke Prevention Intervention Network, Hamilton, Ontario, Canada.Search for more papers by this author, Noah Ivers, MD, PhDFrom the University of Toronto Department of Medicine; Sunnybrook Regional Stroke Prevention Clinic, Hurvitz Brain Sciences Program, Dr. Thomas and Harriet Black Rapid TIA Clinic, and Anticoagulant Management Clinic and Thromboembolism Service, Sunnybrook Health Sciences Centre; University of Toronto Stroke Program; Family Practice Health Centre, Women's College Research Institute, and Institute for Health Systems Solutions and Virtual Care, Women's College Hospital;and University Health Network and OpenLab, University Health Network, Toronto, Ontario, Canada, and McMaster University, Population Health Research Institute, and Canadian Stroke Prevention Intervention Network, Hamilton, Ontario, Canada.Search for more papers by this author, Jeff S. Healey, MDFrom the University of Toronto Department of Medicine; Sunnybrook Regional Stroke Prevention Clinic, Hurvitz Brain Sciences Program, Dr. Thomas and Harriet Black Rapid TIA Clinic, and Anticoagulant Management Clinic and Thromboembolism Service, Sunnybrook Health Sciences Centre; University of Toronto Stroke Program; Family Practice Health Centre, Women's College Research Institute, and Institute for Health Systems Solutions and Virtual Care, Women's College Hospital;and University Health Network and OpenLab, University Health Network, Toronto, Ontario, Canada, and McMaster University, Population Health Research Institute, and Canadian Stroke Prevention Intervention Network, Hamilton, Ontario, Canada.Search for more papers by this author, and Kori Leblanc, PharmDFrom the University of Toronto Department of Medicine; Sunnybrook Regional Stroke Prevention Clinic, Hurvitz Brain Sciences Program, Dr. Thomas and Harriet Black Rapid TIA Clinic, and Anticoagulant Management Clinic and Thromboembolism Service, Sunnybrook Health Sciences Centre; University of Toronto Stroke Program; Family Practice Health Centre, Women's College Research Institute, and Institute for Health Systems Solutions and Virtual Care, Women's College Hospital;and University Health Network and OpenLab, University Health Network, Toronto, Ontario, Canada, and McMaster University, Population Health Research Institute, and Canadian Stroke Prevention Intervention Network, Hamilton, Ontario, Canada.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-0143 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Anticoagulation for atrial fibrillation with direct oral anticoagulants (DOACs)—apixaban, dabigatran, edoxaban, and rivaroxaban—is one of the most powerful stroke prevention interventions (1) and is now being prescribed to millions worldwide. Guidelines, however, have focused primarily on patient selection and therapy initiation, with little guidance on patient follow-up and monitoring for these long-term therapies. Given the increasing use of these agents, their associated risks for bleeding and nonadherence (one quarter of patients in recent reports was less than 80% adherent [2–4]), the absence of routine coagulation monitoring, and variable follow-up practices, we advocate regular, standardized clinical monitoring of patients receiving these ...

Ten years of change in clinical disease status and treatment in rheumatoid arthritis: results based on standardized monitoring of patients in an ordinary outpatient clinic in southern Norway.

IntroductionIn the new millennium, clinical outcomes in patients with rheumatoid arthritis (RA) have improved. Despite a large number of register data, there is a lack of data reflecting the entire outpatient RA population, and in particular long-term data. The main aim of this study was to explore changes in clinical disease status and treatment in an RA outpatient clinic population monitored with recommended outcome measures over a 10-year period.MethodsStandard data collected included demographic data, erythrocyte sedimentation rate, C-reactive protein, clinical measures of disease activity (Disease Activity Score in 28 joint counts [DAS28], Clinical Disease Activity Index [CDAI], Simplified Disease Activity Index [SDAI] and global assessments) and patient-reported outcomes (measures of physical function, joint pain, fatigue, patient global assessment and morning stiffness). Treatment with disease-modifying antirheumatic drugs (DMARDs) was also recorded, as well as rheumatoid factor (RF) and anti-citrullinated protein antibody (ACPA) status.ResultsIn the RA population, the mean age was approximately 64 years and disease duration was 10–12 years. About 70 % were females; approximately 20 % were current smokers; and 65–70 % were positive for RF and ACPA. During follow-up, disease activity improved significantly. When we applied the DAS28, CDAI, SDAI and Boolean criteria for remission, the proportions of patients in remission increased from 21.3 %, 8.1 %, 5.8 % and 3.8 %, respectively, in 2004 to 55.5 %, 31.7 %, 31.8 % and 17.7 %, respectively, in 2013. The proportions of patients with DAS28, CDAI and SDAI low disease activity status were 16.0 %, 34.0 %, and 34.9 %, respectively, in 2004 and 17.8 %, 50.4 % and 50.8 %, respectively, in 2013. A significant improvement in patient-reported outcome was seen only for the full 10-years, but not for the last 4 years, of the study period. The proportion of patients taking synthetic (about 60 %) and biologic (approximately 30 %) DMARDs was stable over the last 4 years of the study period, with no significant change observed, whereas the proportion of patients being treated with prednisolone was reduced significantly from 61 % in 2010 to 54 % in 2013.ConclusionsThe encouraging data we present suggest that the vast majority of patients with RA monitored in outpatient clinics in the new millennium can expect to achieve a status of clinical remission or low disease activity.

Guidelines for the Standard Monitoring of Patients With Thalassemia: Report of the Thalassemia Longitudinal Cohort.

Chronic transfusion therapy has played a central role in extending life expectancy for patients with hemoglobinopathies such as thalassemia. However, this life-saving therapy is associated with numerous complications that now comprise the bulk of management considerations for patients with thalassemia. This review reports on the experience of the Thalassemia Longitudinal Cohort and reviews available literature to establish guidelines for the management of patients with thalassemia.

Guideline on the management of acute chest syndrome in sickle cell disease.

1. Department of Haematology, Guy’s and St Thomas’ NHS Foundation Trust 2. Lane Fox Respiratory Unit, St Thomas’ Hospital, Guy’s and St Thomas’ NHS Foundation Trust 3. Department of Haematology, North Middlesex Hospital 4. Department of Paediatric Haematology, Bristol Royal Hospital for Children 5. Department of Haematological Medicine, King’s College Hospital 6. Department of Haematology, Whittington Hospital

MouthLab: A Tricorder Concept Optimized for Rapid Medical Assessment.

The goal of rapid medical assessment (RMA) is to estimate the general health of a patient during an emergency room or a doctor's office visit, or even while the patient is at home. Currently the devices used during RMA are typically "all-in-one" vital signs monitors. They require time, effort and expertise to attach various sensors to the body. A device optimized for RMA should instead require little effort or expertise to operate and be able to rapidly obtain and consolidate as much information as possible. MouthLab is a battery powered hand-held device intended to acquire and evaluate many measurements such as non-invasive blood sugar, saliva and respiratory biochemistry. Our initial prototype acquires standard vital signs: pulse rate (PR), breathing rate (BR), temperature (T), blood oxygen saturation (SpO2), blood pressure (BP), and a three-lead electrocardiogram. In our clinical study we tested the device performance against the measurements obtained with a standard patient monitor. 52 people participated in the study. The measurement errors were as follows: PR: -1.7±3.5BPM, BR: 0.4±2.4BPM, T: -0.4±1.24°F, SpO2: -0.6±1.7%. BP systolic: -1.8±12mmHg, BP diastolic: 0.6±8mmHg. We have shown that RMA can be easily performed non-invasively by patients with no prior training.

AB0358 Impact of Morning Stiffness Duration in Rheumatoid Arthritis Activity's Evaluation/Study Data QUEST-RA Morocco

ObjectivesTo evaluate the impact of morning stiffness duration reported by the patient on the evaluation of rheumatoid arthritis activity.MethodsA multi- national cross-sectional study that included 1129 patients with rheumatoid arthritis...