Intracranial compliance and volumetry in patients with traumatic brain injury.

Background: Cerebral edema (CE) and intracranial hypertension (IHT) are complications of numerous neurological pathologies. However, the study of CE and noninvasive methods to predict IHT remains rudimentary. This study aims to identify in traumatic brain injury (TBI) patients the relationship between the volume of the lateral ventricles and the parameters of the noninvasive intracranial pressure waveform (nICPW). Methods: This is an analytical, descriptive, and cross-sectional study with nonsurgical TBI patients. The monitoring of nICPW was performed with a mechanical strain gauge, and the volumetry of the lateral ventricles was calculated using the free 3D Slicer software, both during the acute phase of the injury. The linear model of fixed and random mixed effects with Gamma was used to calculate the influence of nICPW parameters (P2/P1 and time-to-peak [TTP]) values on volumetry. Results: Considering only the fixed effects of the sample, there was P = 0.727 (95% CI [-0.653; 0.364]) for the relationship between P2/P1 and volumetry and 0.727 (95% CI [-1.657; 1.305]) for TTP and volumetry. Considering the fixed and random effects, there was P = 8.5e-10 (95% CI [-0.759; 0.355]) for the relationship between P2/P1 and volumetry and 8.5e-10 (95% CI [-2.001; 0.274]) for TTP and volumetry. Conclusion: The present study with TBI patients found association between nICPW parameters and the volume of the lateral ventricles in the 1st days after injury.

Interoperable, Domain-Specific Extensions for the German Corona Consensus (GECCO) COVID-19 Research Data Set Using an Interdisciplinary, Consensus-Based Workflow: Data Set Development Study.

Background: The COVID-19 pandemic has spurred large-scale, interinstitutional research efforts. To enable these efforts, researchers must agree on data set definitions that not only cover all elements relevant to the respective medical specialty but also are syntactically and semantically interoperable. Therefore, the German Corona Consensus (GECCO) data set was developed as a harmonized, interoperable collection of the most relevant data elements for COVID-19-related patient research. As the GECCO data set is a compact core data set comprising data across all medical fields, the focused research within particular medical domains demands the definition of extension modules that include data elements that are the most relevant to the research performed in those individual medical specialties. Objective: We aimed to (1) specify a workflow for the development of interoperable data set definitions that involves close collaboration between medical experts and information scientists and (2) apply the workflow to develop data set definitions that include data elements that are the most relevant to COVID-19-related patient research regarding immunization, pediatrics, and cardiology. Methods: We developed a workflow to create data set definitions that were (1) content-wise as relevant as possible to a specific field of study and (2) universally usable across computer systems, institutions, and countries (ie, interoperable). We then gathered medical experts from 3 specialties-infectious diseases (with a focus on immunization), pediatrics, and cardiology-to select data elements that were the most relevant to COVID-19-related patient research in the respective specialty. We mapped the data elements to international standardized vocabularies and created data exchange specifications, using Health Level Seven International (HL7) Fast Healthcare Interoperability Resources (FHIR). All steps were performed in close interdisciplinary collaboration with medical domain experts and medical information specialists. Profiles and vocabulary mappings were syntactically and semantically validated in a 2-stage process. Results: We created GECCO extension modules for the immunization, pediatrics, and cardiology domains according to pandemic-related requests. The data elements included in each module were selected, according to the developed consensus-based workflow, by medical experts from these specialties to ensure that the contents aligned with their research needs. We defined data set specifications for 48 immunization, 150 pediatrics, and 52 cardiology data elements that complement the GECCO core data set. We created and published implementation guides, example implementations, and data set annotations for each extension module. Conclusions: The GECCO extension modules, which contain data elements that are the most relevant to COVID-19-related patient research on infectious diseases (with a focus on immunization), pediatrics, and cardiology, were defined in an interdisciplinary, iterative, consensus-based workflow that may serve as a blueprint for developing further data set definitions. The GECCO extension modules provide standardized and harmonized definitions of specialty-related data sets that can help enable interinstitutional and cross-country COVID-19 research in these specialties.

Lived experiences of patients implanted with left ventricular assist devices.

BACKGROUND: Besides survival, improvement in quality of life (QoL) is a major aim of left ventricular assist device (LVAD) implantation. QoL assessment tools in current use are effective in the gathering of standardized metrics but are limited in their ability to elucidate everyday lived patient experiences that also affect overall patient wellbeing. OBJECTIVE: To describe and understand the lived experiences of patients undergoing long-term circulatory support with LVAD. METHODS: A phenomenological approach was used. Purposive sampling of consecutive willing inpatients and outpatients living with an LVAD for longer than 6 months was conducted until theme saturation. There were a total of 21 patients interviewed and this was then recorded and transcribed. RESULTS: A total of eight themes emerged from the data. Overall, the patients' quality of life was affected by: (1) whether they had experienced improvements or setbacks in their recent health condition, (2) experiencing burdens from their device such as weight and handling, (3) limitations in their physical ability such as participating in sports, their inability to work; or reduced sleep, (4) reduced social interactions; (5) reduction in sexual activity and performance; (6) experiencing emotional and psychological problems and experiencing anxiety. Patients highlighted the value of obtaining (7) support from family and friends. The interviews also revealed that some patients experienced the feeling of (8) optimism and obtaining "a second chance" at life. CONCLUSIONS: LVAD patients have unique concerns and lived experiences. Some themes emerging from this interview series such as having to give up work, having reduced social contact, reduced sexual activity and emotional problems, family support structures demand careful attention during the pre-implantation counselling and post implantation ongoing care. These aspects also deserve more attention in quality of life studies among LVAD patients. Patients with recent improvements in health reported a more positive outlook. Overall the majority of patients reported feeling that they obtained a second chance at life.

Fast Healthcare Interoperability Resources (FHIR) for Interoperability in Health Research: Systematic Review.

BACKGROUND: The standard Fast Healthcare Interoperability Resources (FHIR) is widely used in health information technology. However, its use as a standard for health research is still less prevalent. To use existing data sources more efficiently for health research, data interoperability becomes increasingly important. FHIR provides solutions by offering resource domains such as "Public Health & Research" and "Evidence-Based Medicine" while using already established web technologies. Therefore, FHIR could help standardize data across different data sources and improve interoperability in health research. OBJECTIVE: The aim of our study was to provide a systematic review of existing literature and determine the current state of FHIR implementations in health research and possible future directions. METHODS: We searched the PubMed/MEDLINE, Embase, Web of Science, IEEE Xplore, and Cochrane Library databases for studies published from 2011 to 2022. Studies investigating the use of FHIR in health research were included. Articles published before 2011, abstracts, reviews, editorials, and expert opinions were excluded. We followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and registered this study with PROSPERO (CRD42021235393). Data synthesis was done in tables and figures. RESULTS: We identified a total of 998 studies, of which 49 studies were eligible for inclusion. Of the 49 studies, most (73%, n=36) covered the domain of clinical research, whereas the remaining studies focused on public health or epidemiology (6%, n=3) or did not specify their research domain (20%, n=10). Studies used FHIR for data capture (29%, n=14), standardization of data (41%, n=20), analysis (12%, n=6), recruitment (14%, n=7), and consent management (4%, n=2). Most (55%, 27/49) of the studies had a generic approach, and 55% (12/22) of the studies focusing on specific medical specialties (infectious disease, genomics, oncology, environmental health, imaging, and pulmonary hypertension) reported their solutions to be conferrable to other use cases. Most (63%, 31/49) of the studies reported using additional data models or terminologies: Systematized Nomenclature of Medicine Clinical Terms (29%, n=14), Logical Observation Identifiers Names and Codes (37%, n=18), International Classification of Diseases 10th Revision (18%, n=9), Observational Medical Outcomes Partnership common data model (12%, n=6), and others (43%, n=21). Only 4 (8%) studies used a FHIR resource from the domain "Public Health & Research." Limitations using FHIR included the possible change in the content of FHIR resources, safety, legal matters, and the need for a FHIR server. CONCLUSIONS: Our review found that FHIR can be implemented in health research, and the areas of application are broad and generalizable in most use cases. The implementation of international terminologies was common, and other standards such as the Observational Medical Outcomes Partnership common data model could be used as a complement to FHIR. Limitations such as the change of FHIR content, lack of FHIR implementation, safety, and legal matters need to be addressed in future releases to expand the use of FHIR and, therefore, interoperability in health research.

Development of tricuspid regurgitation and right ventricular performance after implantation of centrifugal left ventricular assist devices.

BACKGROUND: Tricuspid regurgitation (TR) after left ventricular assist device (LVAD) implantation is associated with a poor prognosis. This study evaluates the development of TR and right ventricular (RV) performance after LVAD implantation. METHODS: Retrospective analysis of patients who underwent LVAD implantation between March 2018 and June 2019. Patients who underwent concomitant tricuspid valve surgery and patients with congenital heart disease were excluded. RESULTS: A total of 155 patients underwent LVAD implantation. Fourteen patients were excluded. Of the remaining patients, thirty-one died during the first six months, six were lost to follow-up and two underwent transplantation. 102 patients presented at 6.3 months (5.8 to 7.0). Patients were supported with HeartWare HVAD (74%) or HeartMate 3 (26%). 50.4% were rated as INTERMACS profile 1 or 2. At six months, systolic pulmonary artery pressure dropped from 36 to 21 mmHg (P<0.001). Tricuspid annular plane systolic excursion decreased from 17.3 to 14.3 mm (P<0.001), RV fractional area change did not change (P=0.839). Twenty-two patients (22%) presented with moderate-to-severe or severe (ms-s) TR pre-operatively. Of these, eighteen (81%) showed improvement to ≤ moderate TR. At follow-up twelve patients presented with ms-s TR. Of these, only four patients (33%) had been diagnosed with ms-s TR pre-operatively. There were no differences in pre-operative echocardiographic or clinical parameters between the twelve patients with ms-s late TR and the other ninety patients in the cohort. CONCLUSIONS: TR can show an impressive improvement with LVAD support. Longitudinal RV function decreases; this appears to be compensated by transverse shortening. Late TR can develop independently from pre-operative parameters including TR.