The Necessity of Interoperability to Uncover the Full Potential of Digital Health Devices.

Personalized health care can be optimized by including patient-reported outcomes. Standardized and disease-specific questionnaires have been developed and are routinely used. These patient-reported outcome questionnaires can be simple paper forms given to the patient to fill out with a pen or embedded in digital devices. Regardless of the format used, they provide a snapshot of the patient's feelings and indicate when therapies need to be adjusted. The advantage of digitizing these questionnaires is that they can be automatically analyzed, and patients can be monitored independently of doctor visits. Although the questions of most clinical patient-reported outcome questionnaires follow defined standards and are evaluated by clinical trials, these standards do not exist for data processing. Interoperable data formats and structures would benefit multilingual and cross-study data exchange. Linking questionnaires to standardized terminologies such as the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) and Logical Observation Identifiers, Names, and Codes (LOINC) would improve this interoperability. However, linking clinically validated patient-reported outcome questionnaires to clinical terms available in SNOMED CT or LOINC is not as straightforward as it sounds. Here, we report our approach to link patient-reported outcomes from health applications to SNOMED CT or LOINC codes. We highlight current difficulties in this process and outline ways to minimize them.

[Clinical Treatment after Terrorist Attacks - Structures and Processes in Hospitals for terror-related Mass Casualty Incidents]. / Klinische Versorgung bei (Terror-)Anschlägen/lebensbedrohlichen Einsatzlagen.

Due to several peculiarities the clinical treatment after terror-related mass casualty incidents (TerrorMASCAL) differs from handling a conventional MCI. For this reason, TerrorMASCAL situations should get attention as an own entity in hospitals emergency preparedness and response. Among other challenges hospitals surrounding the emergency area will have to deal with a large amount of non-triaged, non-treated and seriously harmed patients, some of them with unfamiliar and disfiguring injuries. In addition, the hospitals themselves can be endangered as a target of further terrorist attacks. Therefore, security concepts depending on the individual circumstances must be elaborated in consultation with the local police authorities.The incident's clinical management should be put in hands of specially trained in-house institutions. Operational and tactical tasks close to patients ("on site") should be separated from strategic and administrative responsibilities ("in the background"). The function of an "Emergency Operational and Medical Coordinator" (EOMC = ZONK) is installed to manage initial diagnostics and therapy for seriously injured victims by prioritization and scheduling available clinical resources.In order to structure the process of emergency admission for numerous patients a triage- and holding area as well as specific in-house treatment areas for different severities of injury should be set up. The clinical triage should follow a consistent algorithm that is based on the cABCDE approach. It is recommended that this algorithm should be defined in hospitals disaster and emergency planning.Surgical strategies concerning the treatment of terror victims might be oriented according to the principles of "tactical abbreviated surgical care" (TASC). This means that in extreme cases the initial measures have to be concerted to save as much lives as possible while accepting a reduced individual outcome.

Interaction Empowerment in Mobile Health: Concepts, Challenges, and Perspectives.

In its most trending interpretation, empowerment in health care is implemented as a patient-centered approach. In the same sense, many mobile health (mHealth) apps are being developed with a primary focus on the individual user. The integration of mHealth apps into the health care system has the potential to counteract existing challenges, including incomplete or nonstandardized medical data and lack of communication, especially in the intersectional context (eg, patients, medical forces). However, concerns about data security and privacy, regional differences in regulations, lack of accessibility, and nontransparent apps hinder the successful integration of mHealth into the health care system. One approach to address this is to rethink the interpretation of empowerment. On that basis, we here examine existing approaches of individual empowerment and subsequently analyze a different view of empowerment in digital health, namely interaction empowerment. Such a change of perspective could positively influence intersectoral communication and facilitate secure data and knowledge sharing. We discuss this novel viewpoint on empowerment, focusing on more efficient integration and development of mHealth approaches. A renewed interpretation of empowerment could thus buffer current limitations of individual empowerment while also advancing digitization of the health system.

Metadata Correction: Patient Empowerment During the COVID-19 Pandemic by Ensuring Safe and Fast Communication of Test Results: Implementation and Performance of a Tracking System.

[This corrects the article DOI: 10.2196/27348.].

Patient Empowerment During the COVID-19 Pandemic by Ensuring Safe and Fast Communication of Test Results: Implementation and Performance of a Tracking System.

BACKGROUND: Overcoming the COVID-19 crisis requires new ideas and strategies for online communication of personal medical information and patient empowerment. Rapid testing of a large number of subjects is essential for monitoring and delaying the spread of SARS-CoV-2 in order to mitigate the pandemic's consequences. People who do not know that they are infected may not stay in quarantine and, thus, risk infecting others. Unfortunately, the massive number of COVID-19 tests performed is challenging for both laboratories and the units that conduct throat swabs and communicate the results. OBJECTIVE: The goal of this study was to reduce the communication burden for health care professionals. We developed a secure and easy-to-use tracking system to report COVID-19 test results online that is simple to understand for the tested subjects as soon as these results become available. Instead of personal calls, the system updates the status and the results of the tests automatically. This aims to reduce the delay when informing testees about their results and, consequently, to slow down the virus spread. METHODS: The application in this study draws on an existing tracking tool. With this open-source and browser-based online tracking system, we aim to minimize the time required to inform the tested person and the testing units (eg, hospitals or the public health care system). The system can be integrated into the clinical workflow with very modest effort and avoids excessive load to telephone hotlines. RESULTS: The test statuses and results are published on a secured webpage, enabling regular status checks by patients; status checks are performed without the use of smartphones, which has some importance, as smartphone usage diminishes with age. Stress tests and statistics show the performance of our software. CTest is currently running at two university hospitals in Germany-University Hospital Ulm and University Hospital Tübingen-with thousands of tests being performed each week. Results show a mean number of 10 (SD 2.8) views per testee. CONCLUSIONS: CTest runs independently of existing infrastructures, aims at straightforward integration, and aims for the safe transmission of information. The system is easy to use for testees. QR (Quick Response) code links allow for quick access to the test results. The mean number of views per entry indicates a reduced amount of time for both health care professionals and testees. The system is quite generic and can be extended and adapted to other communication tasks.

Reduced Rate of Inpatient Hospital Admissions in 18 German University Hospitals During the COVID-19 Lockdown.

The COVID-19 pandemic has caused strains on health systems worldwide disrupting routine hospital services for all non-COVID patients. Within this retrospective study, we analyzed inpatient hospital admissions across 18 German university hospitals during the 2020 lockdown period compared to 2018. Patients admitted to hospital between January 1 and May 31, 2020 and the corresponding periods in 2018 and 2019 were included in this study. Data derived from electronic health records were collected and analyzed using the data integration center infrastructure implemented in the university hospitals that are part of the four consortia funded by the German Medical Informatics Initiative. Admissions were grouped and counted by ICD 10 chapters and specific reasons for treatment at each site. Pooled aggregated data were centrally analyzed with descriptive statistics to compare absolute and relative differences between time periods of different years. The results illustrate how care process adoptions depended on the COVID-19 epidemiological situation and the criticality of the disease. Overall inpatient hospital admissions decreased by 35% in weeks 1 to 4 and by 30.3% in weeks 5 to 8 after the lockdown announcement compared to 2018. Even hospital admissions for critical care conditions such as malignant cancer treatments were reduced. We also noted a high reduction of emergency admissions such as myocardial infarction (38.7%), whereas the reduction in stroke admissions was smaller (19.6%). In contrast, we observed a considerable reduction in admissions for non-critical clinical situations, such as hysterectomies for benign tumors (78.8%) and hip replacements due to arthrosis (82.4%). In summary, our study shows that the university hospital admission rates in Germany were substantially reduced following the national COVID-19 lockdown. These included critical care or emergency conditions in which deferral is expected to impair clinical outcomes. Future studies are needed to delineate how appropriate medical care of critically ill patients can be maintained during a pandemic.

Stalking a lethal superbug by whole-genome sequencing and phylogenetics: Influence on unraveling a major hospital outbreak of carbapenem-resistant Klebsiella pneumoniae.

BACKGROUND: From July 2010-April 2013, Leipzig University Hospital experienced the largest outbreak of a Klebsiella pneumoniae carbapenemase 2 (KPC-2)-producing Klebsiella pneumoniae (KPC-2-Kp) strain observed in Germany to date. After termination of the outbreak, we aimed to reconstruct transmission pathways by phylogenetics based on whole-genome sequencing (WGS). METHODS: One hundred seventeen KPC-2-Kp isolates from 89 outbreak patients, 5 environmental KPC-2-Kp isolates, and 24 K pneumoniae strains not linked to the outbreak underwent WGS. Phylogenetic analysis was performed blinded to clinical data and based on the genomic reads. RESULTS: A patient from Greece was confirmed as the source of the outbreak. Transmission pathways for 11 out of 89 patients (12.4%) were plausibly explained by descriptive epidemiology, applying strict definitions. Five of these and an additional 15 (ie, 20 out of 89 patients [22.5%]) were confirmed by phylogenetics. The rate of phylogenetically confirmed transmissions increased significantly from 8 out of 66 (12.1% for the time period before) to 12 out of 23 patients (52.2% for the time period after; P <.001) after implementation of systematic screening for KPC-2-Kp (33,623 screening investigations within 11 months). Using descriptive epidemiology, systematic screening showed no significant effect (7 out of 66 [10.6%] vs 4 out of 23 [17.4%] patients; P = .465). The phylogenetic analysis supported the assumption that a contaminated positioning pillow served as a reservoir for the persistence of KPC-2-Kp. CONCLUSIONS: Effective phylogenetic identification of transmissions requires systematic microbiologic screening. Extensive screening and phylogenetic analysis based on WGS should be started as soon as possible in a bacterial outbreak situation.

Effect of a multifaceted educational intervention for anti-infectious measures on sepsis mortality: a cluster randomized trial.

PURPOSE: Guidelines recommend administering antibiotics within 1 h of sepsis recognition but this recommendation remains untested by randomized trials. This trial was set up to investigate whether survival is improved by reducing the time before initiation of antimicrobial therapy by means of a multifaceted intervention in compliance with guideline recommendations. METHODS: The MEDUSA study, a prospective multicenter cluster-randomized trial, was conducted from July 2011 to July 2013 in 40 German hospitals. Hospitals were randomly allocated to receive conventional continuous medical education (CME) measures (control group) or multifaceted interventions including local quality improvement teams, educational outreach, audit, feedback, and reminders. We included 4183 patients with severe sepsis or septic shock in an intention-to-treat analysis comparing the multifaceted intervention (n = 2596) with conventional CME (n = 1587). The primary outcome was 28-day mortality. RESULTS: The 28-day mortality was 35.1% (883 of 2596 patients) in the intervention group and 26.7% (403 of 1587 patients; p = 0.01) in the control group. The intervention was not a risk factor for mortality, since this difference was present from the beginning of the study and remained unaffected by the intervention. Median time to antimicrobial therapy was 1.5 h (interquartile range 0.1-4.9 h) in the intervention group and 2.0 h (0.4-5.9 h; p = 0.41) in the control group. The risk of death increased by 2% per hour delay of antimicrobial therapy and 1% per hour delay of source control, independent of group assignment. CONCLUSIONS: Delay in antimicrobial therapy and source control was associated with increased mortality but the multifaceted approach was unable to change time to antimicrobial therapy in this setting and did not affect survival.

Search for an animal model to investigate selective pulmonary vasodilation.

Pulmonary arterial hypertension is a life-threatening disease with a poor prognosis. Oral treatment with vasodilators is often limited by systemic hypotension. Inhalation of vasodilators offers the opportunity for selective pulmonary vasodilation. Testing selective pulmonary vasodilation by inhaled nitric oxide or alternative substances in animal models requires an increased pulmonary vascular tone. The aim of this study was to identify animal models that are suitable for investigating selective pulmonary vasodilation. To do so, a haemodynamic stable pulmonary hypertension was initiated, with a 30 min duration deemed to be a sufficient time interval before and after a possible intervention. In anaesthetized and mechanically-ventilated Sprague-Dawley rats pulmonary hypertension was induced either by acute hypoxia due to reduction of the inspired oxygen fraction from 0.21 to 0.1 ( n = 6), a fixed infusion rate of the thromboxane analogue U46619 (240 ng/min; n = 6) or a monocrotaline injection (MCT; 60 mg/kg applied 23 days before the investigation; n = 7). The animals were instrumented to measure right ventricular and systemic arterial pressures. Acute hypoxia caused a short, and only transient, increase of pulmonary artery pressure as well as profound systemic hypotension which suggested haemodynamic instability. U46619 infusion induced variable changes in the pulmonary and systemic vascular tone without sufficient stabilization within 30 min. MCT provoked sustained pulmonary hypertension with normal systemic pressure values and inhalation of nitric oxide caused selective pulmonary vasodilation. In conclusion, out of the three examined rat animal models only MCT-induced pulmonary hypertension is a solid and reliable model for investigating selective pulmonary vasodilation.

Laryngeal tube suction II or endotracheal intubation for laparoscopic radical prostatectomy in a head down position: A randomised controlled trial.

BACKGROUND: The laryngeal tube suction II (LTS II) is a supraglottic airway device (SAD) with a gastric drainage tube and enhanced seal properties as compared with other SADs. Therefore, its use has been proposed in situations with an elevated risk of aspiration. OBJECTIVES: To compare the safety and efficacy of airway management and controlled mechanical ventilation when using either an LTS II or an endotracheal tube for laparoscopic radical prostatectomy. DESIGN: Randomised, controlled, blinded and single-centre study. SETTING: Academic tertiary care centre in Leipzig from April 2014 to May 2015. PATIENTS: It was planned to include 100 patients but the study was stopped after 50 patients following an interim analysis. These 50 patients were randomised to either the LTS II group or the endotracheal tube group. All male patients aged more than 18 years for elective laparoscopic radical prostatectomy were eligible. Exclusion criteria included a BMI more than 30, American Society of Anesthesiologists class III or greater, a history of gastroesophageal reflux or other factors known to increase the risk of aspiration and a known difficult airway. INTERVENTIONS: All patients received general anaesthesia. Airway management was with either a LTS II or an endotracheal tube, according to the randomisation. MAIN OUTCOME MEASURES: The primary endpoint was successful insertion of the particular airway device during anaesthesia for laparoscopic radical prostatectomy. RESULTS: In 15 of the 28 patients randomised to LTS II, the device had to be removed and an endotracheal tube inserted, mainly because of an airway leak (n = 10) or swelling of the tongue (n = 3). Ventilation was successful in all patients (n = 22) randomised to endotracheal tube. Quality of ventilation was rated better in the endotracheal tube group. CONCLUSION: Our data suggest that LTS II should not be the preferred method of airway management in patients undergoing laparoscopic radical prostatectomy. TRIAL REGISTRATION: DRKS00008985 (German Clinical Trials Register).

Effect of Sodium Selenite Administration and Procalcitonin-Guided Therapy on Mortality in Patients With Severe Sepsis or Septic Shock: A Randomized Clinical Trial.

IMPORTANCE: High-dose intravenous administration of sodium selenite has been proposed to improve outcome in sepsis by attenuating oxidative stress. Procalcitonin-guided antimicrobial therapy may hasten the diagnosis of sepsis, but effect on outcome is unclear. OBJECTIVE: To determine whether high-dose intravenous sodium selenite treatment and procalcitonin-guided anti-infectious therapy in patients with severe sepsis affect mortality. DESIGN, SETTING, AND PARTICIPANTS: The Placebo-Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis (SISPCT), a multicenter, randomized, clinical, 2 × 2 factorial trial performed in 33 intensive care units in Germany, was conducted from November 6, 2009, to June 6, 2013, including a 90-day follow-up period. INTERVENTIONS: Patients were randomly assigned to receive an initial intravenous loading dose of sodium selenite, 1000 µg, followed by a continuous intravenous infusion of sodium selenite, 1000 µg, daily until discharge from the intensive care unit, but not longer than 21 days, or placebo. Patients also were randomized to receive anti-infectious therapy guided by a procalcitonin algorithm or without procalcitonin guidance. MAIN OUTCOMES AND MEASURES: The primary end point was 28-day mortality. Secondary outcomes included 90-day all-cause mortality, intervention-free days, antimicrobial costs, antimicrobial-free days, and secondary infections. RESULTS: Of 8174 eligible patients, 1089 patients (13.3%) with severe sepsis or septic shock were included in an intention-to-treat analysis comparing sodium selenite (543 patients [49.9%]) with placebo (546 [50.1%]) and procalcitonin guidance (552 [50.7%]) vs no procalcitonin guidance (537 [49.3%]). The 28-day mortality rate was 28.3% (95% CI, 24.5%-32.3%) in the sodium selenite group and 25.5% (95% CI, 21.8%-29.4%) (P = .30) in the placebo group. There was no significant difference in 28-day mortality between patients assigned to procalcitonin guidance (25.6% [95% CI, 22.0%-29.5%]) vs no procalcitonin guidance (28.2% [95% CI, 24.4%-32.2%]) (P = .34). Procalcitonin guidance did not affect frequency of diagnostic or therapeutic procedures but did result in a 4.5% reduction of antimicrobial exposure. CONCLUSIONS AND RELEVANCE: Neither high-dose intravenous administration of sodium selenite nor anti-infectious therapy guided by a procalcitonin algorithm was associated with an improved outcome in patients with severe sepsis. These findings do not support administration of high-dose sodium selenite in these patients; the application of a procalcitonin-guided algorithm needs further evaluation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00832039.

Two strategies for prevention of cytomegalovirus infections after liver transplantation.

AIM: To analyze differences in patients' clinical course, we compared two regimes of either preemptive therapy or prophylaxis after liver transplantation. METHODS: This retrospective study was reviewed and approved by the institutional review board of the University of Leipzig. Cytomegalovirus (CMV) prophylaxis with valganciclovir hydrochloride for liver transplant recipients was replaced by a preemptive strategy in October 2009. We retrospectively compared liver transplant recipients 2 years before and after October 2009. During the first period, all patients received valganciclovir daily. During the second period all patients included in the analysis were treated following a preemptive strategy. Outcomes included one year survival and therapeutic intervention due to CMV viremia or infection. RESULTS: Between 2007 and 2010 n = 226 patients underwent liver transplantation in our center. n = 55 patients were D(+)/R(-) high risk recipients and were excluded from further analysis. A further 43 patients had to be excluded since CMV prophylaxis/preemptive strategy was not followed although there was no clinical reason for the deviation. Of the remaining 128 patients whose data were analyzed, 60 received prophylaxis and 68 were treated following a preemptive strategy. The difference in overall mortality was not significant, nor was it significant for one-year mortality where it was 10% (95%CI: 8%-28%, P = 0.31) higher for the preemptive group. No significant differences in blood count abnormalities or the incidence of sepsis and infections were observed other than CMV. In total, 19 patients (14.7%) received ganciclovir due to CMV viremia and/or infections. Patients who were treated according to the preemptive algorithm had a significantly higher rate risk of therapeutic intervention with ganciclovir [n = 16 (23.5%) vs n = 3 (4.9%), P = 0.003)]. CONCLUSION: These data suggest that CMV prophylaxis is superior to a preemptive strategy in patients undergoing liver transplantation.

Inhaled carbon monoxide protects time-dependently from loss of hypoxic pulmonary vasoconstriction in endotoxemic mice.

BACKGROUND: Inhaled carbon monoxide (CO) appears to have beneficial effects on endotoxemia-induced impairment of hypoxic pulmonary vasoconstriction (HPV). This study aims to specify correct timing of CO application, it's biochemical mechanisms and effects on inflammatory reactions. METHODS: Mice (C57BL/6; n = 86) received lipopolysaccharide (LPS, 30 mg/kg) intraperitoneally and subsequently breathed 50 ppm CO continuously during defined intervals of 3, 6, 12 or 18 h. Two control groups received saline intraperitoneally and additionally either air or CO, and one control group received LPS but breathed air only. In an isolated lung perfusion model vasoconstrictor response to hypoxia (FiO2 = 0.01) was quantified by measurements of pulmonary artery pressure. Pulmonary capillary pressure was estimated by double occlusion technique. Further, inflammatory plasma cytokines and lung tissue mRNA of nitric-oxide-synthase-2 (NOS-2) and heme oxygenase-1 (HO-1) were measured. RESULTS: HPV was impaired after LPS-challenge (p < 0.01). CO exposure restored HPV-responsiveness if administered continuously for full 18 h, for the first 6 h and if given in the interval between the 3(rd) and 6(th) hour after LPS-challenge (p < 0.05). Preserved HPV was attributable to recovered arterial resistance and associated with significant reduction in NOS-2 mRNA when compared to controls (p < 0.05). We found no effects on inflammatory plasma cytokines. CONCLUSION: Low-dose CO prevented LPS-induced impairment of HPV in a time-dependent manner, associated with a decreased NOS-2 expression.

Initial Experience With a Percutaneous Approach to Redo Mitral Valve Surgery: Management and Procedural Success.

OBJECTIVE: The purpose of the study was to report the anesthetic management and immediate procedural success in the initial 20 patients undergoing percutaneous transapical mitral valve replacement. DESIGN: Retrospective review of collected data. SETTING: University-affiliated heart center. PARTICIPANTS: Twenty patients with mitral regurgitation or stenosis due to a degenerated valve or ring in the mitral position. INTERVENTIONS: TEE-guided transapical mitral valve replacement under general anesthesia and early extubation by means of an established fast-track protocol. MEASUREMENTS AND MAIN METHODS: Twenty patients underwent transapical mitral valve replacement by a beating heart procedure, avoiding cardiopulmonary bypass. The valve was either deployed due to a previously implanted bioprosthetic valve (valve-in-valve group), which degenerated, or a ring (valve-in-ring group), which predominantly showed regurgitation. There was a significant increase in the mitral valve opening area in stenosed valve pathology from 1.3-1.9 sq. cm (p = 0.004), and an increase in ejection fraction from 40% to 45% (p = 0.52). In the valve-in-ring group, valve area increased from 2.0 sq. cm to 2.6 sq. cm (p = 0.21), with an increase in ejection fraction from 30% to 35% (p = 0.18). Eighteen patients underwent successful deployment of the valve. The anesthesia duration for the procedure lasted 185.5 ± 25.4 minutes. CONCLUSIONS: There was a significant increase in opening area of the valve and improvement in ejection fraction in this patient group. TEE and fluoroscopy-guided imaging is necessary for the procedure's success and is an evolving alternative treatment for high-risk mitral valve patients who would otherwise be considered inoperable for routine surgery using sternotomy.

The effect of intraoperative administration of dexamethasone for PONV prophylaxis on perioperative blood glucose level in obese and normal weight children.

BACKGROUND: The incidence of postoperative nausea and vomiting (PONV) can be reduced by dexamethasone. Single-dose administration may cause elevated blood glucose levels in obese adults. No data are available for children. OBJECTIVE: The aim was to evaluate perioperative blood glucose changes related to body weight in children who received dexamethasone. PATIENTS AND METHODS: This prospective observational study included 62 children. All patients received total intravenous anesthesia and a single dose of dexamethasone (0.15 mg/kg, maximum 8 mg). Blood glucose levels were measured up to 6 h. Standard deviation scores (SDS) were calculated using age- and gender-specific body mass index (BMI) percentiles, p<0.05. RESULTS: A total of 62 children (11.5±2.9 years, median SDS 0.43, 29% overweight/obese) were included. Blood glucose levels increased from 5.52±0.52 to 6.74±0.84 mmol/L 6 h after dexamethasone without correlation to the BMI-SDS. CONCLUSIONS: This study showed an increase of perioperative blood glucose (normoglycemic ranges) after single dose of dexamethasone, but no BMI-dependent effect was observed in children. Therefore, low-dose dexamethasone may be used in obese children for PONV prophylaxis.

[Mechanically circulatory support devices--management of typical emergencies]. / Patienten mit linksventrikulären Assist Devices--Typische Notfälle versorgen.

The use of mechanically circulatory support devices (MCS) will become increasingly important as a therapy option in patients with end-stage heart failure, and emergency physicians will more frequently encounter MCS patients in the next few years. However, emergency management in MCS patients has not yet been standardized. In the following article, common MCS devices are presented and typical emergencies associated with MCS devices are discussed. Furthermore, we try to give recommendations for the management of MCS patients in an emergency situation and present an algorithm in order to facilitate a structured and timely efficient evaluation of the MCS patient.