Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial.

BACKGROUND: Opioid-related adverse events are a serious problem in hospitalized patients. Little is known about patients who are likely to experience opioid-induced respiratory depression events on the general care floor and may benefit from improved monitoring and early intervention. The trial objective was to derive and validate a risk prediction tool for respiratory depression in patients receiving opioids, as detected by continuous pulse oximetry and capnography monitoring. METHODS: PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) was a prospective, observational trial of blinded continuous capnography and oximetry conducted at 16 sites in the United States, Europe, and Asia. Vital signs were intermittently monitored per standard of care. A total of 1335 patients receiving parenteral opioids and continuously monitored on the general care floor were included in the analysis. A respiratory depression episode was defined as respiratory rate ≤5 breaths/min (bpm), oxygen saturation ≤85%, or end-tidal carbon dioxide ≤15 or ≥60 mm Hg for ≥3 minutes; apnea episode lasting \u3e30 seconds; or any respiratory opioid-related adverse event. A risk prediction tool was derived using a multivariable logistic regression model of 46 a priori defined risk factors with stepwise selection and was internally validated by bootstrapping. RESULTS: One or more respiratory depression episodes were detected in 614 (46%) of 1335 general care floor patients (43% male; mean age, 58 ± 14 years) continuously monitored for a median of 24 hours (interquartile range [IQR], 17-26). A multivariable respiratory depression prediction model with area under the curve of 0.740 was developed using 5 independent variables: age ≥60 (in decades), sex, opioid naivety, sleep disorders, and chronic heart failure. The PRODIGY risk prediction tool showed significant separation between patients with and without respiratory depression (P \u3c .001) and an odds ratio of 6.07 (95% confidence interval [CI], 4.44-8.30; P \u3c .001) between the high- and low-risk groups. Compared to patients without respiratory depression episodes, mean hospital length of stay was 3 days longer in patients with ≥1 respiratory depression episode (10.5 ± 10.8 vs 7.7 ± 7.8 days; P \u3c .0001) identified using continuous oximetry and capnography monitoring. CONCLUSIONS: A PRODIGY risk prediction model, derived from continuous oximetry and capnography, accurately predicts respiratory depression episodes in patients receiving opioids on the general care floor. Implementation of the PRODIGY score to determine the need for continuous monitoring may be a first step to reduce the incidence and consequences of respiratory compromise in patients receiving opioids on the general care floor

Tracing Transnational Flows of IT Knowledge Through Open Exchange of Software Development Know-How

Information technology (IT) is often promoted as a socially and culturally agnostic tool that will allow emerging economies to leap into the digital age and reap the wealth that accompanies it. But in addition to the programming language, software tools, and books, know-how is needed to turn bright ideas into innovative, marketable solutions. This know-how can only be acquired from experience or from other IT developers. An effective means for sharing know-how is through an open exchange, which we characterize as a space where interested people can learn, critique, and contest ideas. It???s a locale that is defined in terms of activity, rather than geography, technology, or membership. We use open exchanges of know-how as an analytical lens to example historical examples and contemporary instances. While conducting fieldwork in India, we observed open exchange occurring at Barcamp Bangalore. It is through these exchanges of know-how, rather than the transmission of tools or software artifacts that IT knowledge flows between international locales. We conclude this paper with a discussion that is mutually informed by contemporary practice and historical configurations

Technical Authorship: Refiguring the Designer-user Conflict and the Visioning of Collective Technical Futures

This paper argues for the application of authorship analysis to technology design. It extends techniques used in Science Studies to investigate scientific authorship in order to define a concept of technical authorship. To illustrate the potential of this approach, authorship analysis is applied to particular prescriptive software design methodologies including Participatory Design and Agile Software Development. The results of this analysis are the recognition that: a) design methodologies are rhetorics of authorship, b) the designer-user relationship can be seen as a conflict of contested authorship, and c) this conflict can be seen within the tensions in the figuration of the user and the designer along a subject-object continuum. ???Figuration,??? a technique used by Donna Haraway, brings about a new understanding of the centrality of the user in the design process as well as the role of the designer as the contested author technical futures. The implications suggest that design researchers might use authorship as a new approach to the politics of design by re-figuring the designer and user rather than collapsing the distinction between these roles

Systematic review of outcomes and patient heterogeneity in relapsed or refractory diffuse large B-cell lymphoma

Aim: To evaluate trials of systemic therapies in transplant-ineligible or -experienced, relapsed/refractory diffuse large-B cell lymphoma and the impact of patient characteristics on overall response rate (ORR). Patients & methods: Systematically reviewed multiple databases through 22 July 2021. Analyzed variations in patient characteristics and their relationship with ORR across trials. Results: Among 17 included trials, key patient characteristics varied substantially: primary refractory (0–69%), refractory to last line of therapy (LOT) (12–100%), ≥2 prior LOTs (14–100%), ≥3 prior LOTs (0–64%), IPI ≥3 (23–73%), tumor stage III/IV (50–90%) and median age (56–74 years). ORRs varied substantially (25–83%), correlating with these characteristics. Conclusion: Differences in patient characteristics significantly contribute to the variability in ORR across these trials and should be considered when contextualizing efficacy data

Virtual reality-based 3-dimensional localization of stereotactic EEG (SEEG) depth electrodes and related brain anatomy in pediatric epilepsy surgery

INTRODUCTION: The increasing use of stereoelectroencephalography (SEEG) in the USA and the need for three-dimensional (3D) appreciation of complex spatial relationships between implanted stereotactic EEG depth electrodes and surrounding brain and cerebral vasculature are a challenge to clinicians who are used to two-dimensional (2D) appreciation of cortical anatomy having been traditionally trained on 2D radiologic imaging. Virtual reality and its 3D renderings have grown increasingly common in the multifaceted practice of neurosurgery. However, there exists a paucity in the literature regarding this emerging technology in its utilization of epilepsy surgery. METHODS: An IRB-approved, single-center retrospective study identifying all SEEG pediatric patients in which virtual reality was applied was observed. RESULTS: Of the 46 patients identified who underwent an SEEG procedure, 43.5% (20/46) had a 3D rendering (3DR) of their SEEG depth electrodes. All 3DRs were used during patient-family education and discussion among the Epilepsy multidisciplinary team meetings, while 35% (7/20) were used during neuronavigation in surgery. Three successful representative cases of its application were presented. DISCUSSION: Our institution\u27s experience regarding virtual reality in the 3D representation of SEEG depth electrodes and the application to pre-surgical planning, patient-family education, multidisciplinary communication, and intraoperative neuronavigation demonstrate its applicability in comprehensive epilepsy patient care

Supplementary tables: Systematic review of outcomes and patient heterogeneity in relapsed or refractory diffuse large B-cell lymphoma

These are peer-reviewed supplementary materials for the article 'Systematic review of outcomes and patient heterogeneity in relapsed or refractory diffuse large B-cell lymphoma' published in the Journal of Comparative Effectiveness Research.Supplementary Table 1: PICOS criteria defining the scope of the current SLRSupplementary Table 2: Search strategiesSupplementary table 3: MINORS assessmentsSupplementary table 4: Cochrane Risk of Bias 2 assessmentsAim: To evaluate trials of systemic therapies in transplant-ineligible or -experienced, relapsed/refractory diffuse large-B cell lymphoma and the impact of patient characteristics on overall response rate (ORR). Patients & methods: Systematically reviewed multiple databases through 22 July 2021. Analyzed variations in patient characteristics and their relationship with ORR across trials. Results: Among 17 included trials, key patient characteristics varied substantially: primary refractory (0–69%), refractory to last line of therapy (LOT) (12–100%), ≥2 prior LOTs (14–100%), ≥3 prior LOTs (0–64%), IPI ≥3 (23–73%), tumor stage III/IV (50–90%) and median age (56–74 years). ORRs varied substantially (25–83%), correlating with these characteristics. Conclusion: Differences in patient characteristics significantly contribute to the variability in ORR across these trials and should be considered when contextualizing efficacy data.</p

Supplementary tables: Systematic review of outcomes and patient heterogeneity in relapsed or refractory diffuse large B-cell lymphoma

These are peer-reviewed supplementary materials for the article 'Systematic review of outcomes and patient heterogeneity in relapsed or refractory diffuse large B-cell lymphoma' published in the Journal of Comparative Effectiveness Research.Supplementary Table 1: PICOS criteria defining the scope of the current SLRSupplementary Table 2: Search strategiesSupplementary table 3: MINORS assessmentsSupplementary table 4: Cochrane Risk of Bias 2 assessmentsAim: To evaluate trials of systemic therapies in transplant-ineligible or -experienced, relapsed/refractory diffuse large-B cell lymphoma and the impact of patient characteristics on overall response rate (ORR). Patients & methods: Systematically reviewed multiple databases through 22 July 2021. Analyzed variations in patient characteristics and their relationship with ORR across trials. Results: Among 17 included trials, key patient characteristics varied substantially: primary refractory (0–69%), refractory to last line of therapy (LOT) (12–100%), ≥2 prior LOTs (14–100%), ≥3 prior LOTs (0–64%), IPI ≥3 (23–73%), tumor stage III/IV (50–90%) and median age (56–74 years). ORRs varied substantially (25–83%), correlating with these characteristics. Conclusion: Differences in patient characteristics significantly contribute to the variability in ORR across these trials and should be considered when contextualizing efficacy data.</p

Interim analysis of safety and efficacy of ruxolitinib in patients with myelofibrosis and low platelet counts

Abstract Background Ruxolitinib, a Janus kinase 1 and 2 inhibitor, demonstrated improvements in spleen volume, symptoms, and survival over placebo and best available therapy in intermediate-2 or high-risk myelofibrosis patients with baseline platelet counts ≥100 × 109/L in phase III studies. The most common adverse events were dose-dependent anemia and thrombocytopenia, which were anticipated because thrombopoietin and erythropoietin signal through JAK2. These events were manageable, rarely leading to treatment discontinuation. Because approximately one-quarter of MF patients have platelet counts &lt;100 × 109/L consequent to their disease, ruxolitinib was evaluated in this subset of patients using lower initial doses. Interim results of a phase II study of ruxolitinib in myelofibrosis patients with baseline platelet counts of 50-100 × 109/L are reported. Methods Ruxolitinib was initiated at a dose of 5 mg twice daily (BID), and doses could be increased by 5 mg once daily every 4 weeks to 10 mg BID if platelet counts remained adequate. Additional dosage increases required evidence of suboptimal efficacy. Assessments included measurement of spleen volume by MRI, MF symptoms by MF Symptom Assessment Form v2.0 Total Symptom Score [TSS]), Patient Global Impression of Change (PGIC); EORTC QLQ-C30, and safety/tolerability. Results By week 24, 62% of patients achieved stable doses ≥10 mg BID. Median reductions in spleen volume and TSS were 24.2% and 43.8%, respectively. Thrombocytopenia necessitating dose reductions and dose interruptions occurred in 12 and 8 patients, respectively, and occurred mainly in patients with baseline platelet counts ≤75 × 109/L. Seven patients experienced platelet count increases ≥15 × 109/L. Mean hemoglobin levels remained stable over the treatment period. Two patients discontinued for adverse events: 1 for grade 4 retroperitoneal hemorrhage secondary to multiple and suspected pre-existing renal artery aneurysms and 1 for grade 4 thrombocytopenia. Conclusions Results suggest that a low starting dose of ruxolitinib with escalation to 10 mg BID may be appropriate in myelofibrosis patients with low platelet counts. Trial registration ClinicalTrials.gov: NCT01348490