Clinical Mortality in a Large COVID-19 Cohort: Observational Study.

BACKGROUND: Northwell Health, an integrated health system in New York, has treated more than 15,000 inpatients with COVID-19 at the US epicenter of the SARS-CoV-2 pandemic. OBJECTIVE: We describe the demographic characteristics of patients who died of COVID-19, observation of frequent rapid response team/cardiac arrest (RRT/CA) calls for non-intensive care unit (ICU) patients, and factors that contributed to RRT/CA calls. METHODS: A team of registered nurses reviewed the medical records of inpatients who tested positive for SARS-CoV-2 via polymerase chain reaction before or on admission and who died between March 13 (first Northwell Health inpatient expiration) and April 30, 2020, at 15 Northwell Health hospitals. The findings for these patients were abstracted into a database and statistically analyzed. RESULTS: Of 2634 patients who died of COVID-19, 1478 (56.1%) had oxygen saturation levels ≥90% on presentation and required no respiratory support. At least one RRT/CA was called on 1112/2634 patients (42.2%) at a non-ICU level of care. Before the RRT/CA call, the most recent oxygen saturation levels for 852/1112 (76.6%) of these non-ICU patients were at least 90%. At the time the RRT/CA was called, 479/1112 patients (43.1%) had an oxygen saturation of <80%. CONCLUSIONS: This study represents one of the largest reviewed cohorts of mortality that also captures data in nonstructured fields. Approximately 50% of deaths occurred at a non-ICU level of care despite admission to the appropriate care setting with normal staffing. The data imply a sudden, unexpected deterioration in respiratory status requiring RRT/CA in a large number of non-ICU patients. Patients admitted at a non-ICU level of care suffered rapid clinical deterioration, often with a sudden decrease in oxygen saturation. These patients could benefit from additional monitoring (eg, continuous central oxygenation saturation), although this approach warrants further study.

Clinical Mortality Review in a Large COVID-19 Cohort.

BACKGROUND: Northwell Health (Northwell), an integrated health system in New York, treated more than 15000 inpatients with coronavirus disease (COVID-19) at the US epicenter of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. We describe the demographic characteristics of COVID-19 mortalities, observation of frequent rapid response teams (RRT)/cardiac arrest (CA) calls for non-intensive care unit (ICU) patients, and factors that contributed to RRT/CA calls. METHODS: A team of registered nurses reviewed medical records of inpatients who tested positive for SARS-CoV-2 via polymerase chain reaction (PCR) before or on admission and died between March 13 (first Northwell inpatient expiration) and April 30, 2020 at 15 Northwell hospitals. Findings for these patients were abstracted into a database and statistically analyzed. FINDINGS: Of 2634 COVID-19 mortalities, 56.1% had oxygen saturation levels greater than or equal to 90% on presentation and required no respiratory support. At least one RRT/CA was called on 42.2% of patients at a non-ICU level of care. Before the RRT/CA call, the most recent oxygen saturation levels for 76.6% of non-ICU patients were at least 90%. At the time RRT/CA was called, 43.1% had an oxygen saturation less than 80%. INTERPRETATION: This study represents one of the largest cohorts of reviewed mortalities that also captures data in non-structured fields. Approximately 50% of deaths occurred at a non-ICU level of care, despite admission to the appropriate care setting with normal staffing. The data imply a sudden, unexpected deterioration in respiratory status requiring RRT/CA in a large number of non-ICU patients. Patients admitted to a non-ICU level of care suffer rapid clinical deterioration, often with a sudden decrease in oxygen saturation. These patients could benefit from additional monitoring (eg, continuous central oxygenation saturation), although this approach warrants further study.

Effect of a combined brief narrative exposure therapy with case management versus treatment as usual in primary care for patients with traumatic stress sequelae following intensive care medicine: study protocol for a multicenter randomized controlled trial (PICTURE).

BACKGROUND: Traumatic events like critical illness and intensive care are threats to life and bodily integrity and pose a risk factor for posttraumatic stress disorder (PTSD). PTSD affects the quality of life and morbidity and may increase health-care costs. Limited access to specialist care results in PTSD patients being treated in primary care settings. Narrative exposure therapy (NET) is based on the principles of cognitive behavioral therapy and has shown positive effects when delivered by health-care professionals other than psychologists. The primary aims of the PICTURE trial (from "PTSD after ICU survival") are to investigate the effectiveness and applicability of NET adapted for primary care with case management in adults diagnosed with PTSD after intensive care. METHODS/DESIGN: This is an investigator-initiated, multi-center, primary care-based, randomized controlled two-arm parallel group, observer-blinded superiority trial conducted throughout Germany. In total, 340 adult patients with a total score of at least 20 points on the posttraumatic diagnostic scale (PDS-5) 3 months after receiving intensive care treatment will be equally randomized to two groups: NET combined with case management and improved treatment as usual (iTAU). All primary care physicians (PCPs) involved will be instructed in the diagnosis and treatment of PTSD according to current German guidelines. PCPs in the iTAU group will deliver usual care during three consultations. In the experimental group, PCPs will additionally be trained to deliver an adapted version of NET (three sessions) supported by phone-based case management by a medical assistant. At 6 and 12 months after randomization, structured blinded telephone interviews will assess patient-reported outcomes. The primary composite endpoint is the absolute change from baseline at month 6 in PTSD symptom severity measured by the PDS-5 total score, which also incorporates the death of any study patients. Secondary outcomes cover the domains depression, anxiety, disability, health-related quality-of-life, and cost-effectiveness. The principal analysis is by intention to treat. DISCUSSION: If the superiority of the experimental intervention over usual care can be demonstrated, the combination of brief NET and case management could be a treatment option to relieve PTSD-related symptoms and to improve primary care after intensive care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03315390 . Registered on 10 October 2017. German Clinical Trials Register, DRKS00012589 . Registered on 17 October 2017.

"... a certain amount of engineering involved": constructing the public in participatory governance arrangements.

This paper argues that it is time for public understanding of science to develop a critical inventory of the forms, formats and methods of public participation and their respective implications and ambiguities. It highlights the need for analysing not only the limitations and deficiencies of participatory arrangements but also their constructive dimension, in particular the construction of the subject of participation. Looking into participatory governance arrangements in the issue area of genetic testing in Germany and the UK the paper presents a typology of formats according to the way the respective public is constructed and identifies four major constructions of publics: the general public, the pure public, the affected public and the partisan public. Each of these enables certain speaking positions while foreclosing others. The study shows that the main purposes of participatory arrangements in this issue area are knowledge production and education rather than political deliberation and decision-making.

Improved durability of the HeartMate XVE left ventricular assist device provides safe mechanical support up to 1 year but is associated with high risk of device failure in the second year.

BACKGROUND: Life-threatening device failure of the HeartMate VE due to biologic inflow valve incompetence or motor failure is a major drawback of long-term mechanical support when using this left ventricular assist device (LVAD). The new XVE model is the result of recent technical improvements. The aim of this study was to compare the clinical performance and durability of the new and earlier HeartMate versions. METHODS: We analyzed the incidence of device failure and of other device-specific complications (infections, bleeding) in 9 VE and 17 XVE patients. Explanted pumps were examined and biologic valve damage classified according to a score ranging from 0 (no visible damage) to 3 (severe destruction). RESULTS: Mean support time was 145 +/- 92 and 267 +/- 195 days in the VE and XVE groups, respectively (difference not significant [NS]). Survival was 89% (VE) vs 75% (XVE). The incidence of device failure requiring urgent heart transplantation or device replacement was 44% (VE) vs 31% (XVE) (NS). Device failure occurred significantly later in the XVE group (200 +/- 34 vs 487 +/- 53 days, p < 0.01). Causes of device failure were inflow valve incompetence (n = 6) and motor failure (n = 3). Acute device failure caused 1 death in the XVE group. One XVE patient has been on mechanical support for > 483 days. Macroscopic inflow valve damage score after explantation of the devices was 2.2 +/- 1.1 in the VE group and 2.0 +/- 0.8 in the XVE group (NS). CONCLUSIONS: The novel HeartMate XVE offers greater durability and provides reliable mechanical support in the first year. However, there is a high risk of life-threatening device failure in the second year. Further technical refinements are necessary to meet the challenges of safe long-term circulatory assistance.