Clinical characteristics of video-EEG patients: Limited utility of prolonging VEEG study duration beyond 5 days for spell classification.

OBJECTIVE: The objective of the study was to identify the probability of establishing a diagnosis based on the duration of video-electroencephalogram (VEEG) monitoring. Additional aims were to determine whether there is a relationship between clinical characteristics of epilepsy monitoring unit (EMU) patients and VEEG results. METHODS: We studied EMU length of stay and assessed the utility of prolonging studies in patients who had not yet received a diagnosis. Clinical characteristics in 212 consecutive patients admitted for scalp VEEG monitoring were recorded. We collected data including reason for admission, frequency of seizures/spells, gender, age, age at seizure onset, handedness, family history, history of neurologic disease, current and past antiepileptic drugs (AEDs), and prior work-up. Subjects were categorized into five diagnostic groups: epileptic seizures (Epi), nonepileptic events (NEE), mixed epileptic and nonepileptic events (Mixed), nonepileptic events from a physiologic cause (NEEP), and nondiagnostic study without results recorded (ND). RESULTS: The most diagnoses were made during the first day of admission (45%), and by day 3, 82 patients remained without a diagnosis. On day 3, 25 of these patients (33%) received a diagnosis, on day 4, seven (22%) additional patients received a diagnosis, on day 5, 5 patients (35%) received a diagnosis, and by day 6, only one additional patient (11%) was given a diagnosis. Significant differences were found between diagnostic groups for admission reason, duration of EMU stay, age at seizure onset, duration of epilepsy, seizure frequency, and number of current and previously tried AEDs. CONCLUSIONS: Our findings show that the majority of patients are diagnosed in the first 2 days of admission, and we found a limited benefit of prolonging nonsurgical inpatient VEEG studies beyond 5 days for spell/seizure classification. Additionally, patient demographics were significantly different for patients depending on VEEG diagnosis, which can help predict the utility of completing VEEG studies in individual patients.

NI-RADS for head and neck cancer surveillance imaging: What, why, and how.

The Neck Imaging Reporting and Data System (NI-RADS) was conceived in 2016 with the objective of standardizing assessment and reporting in surveillance imaging for patients with head and neck squamous cell carcinomas and their subsequent management. The goals are to simplify radiology reports while increasing the consistency and accuracy of the interpretation of cancer surveillance imaging; enable better communication among clinicians and between clinicians and patients; facilitate outcomes research; and ultimately improve patient survival, morbidity, and mortality. The objective of the current study was to provide the background as to why and how NI-RADS was conceived and what it entails in radiology reporting.

Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator. Final order.

The Food and Drug Administration (FDA) is classifying the adjunctive cardiovascular status indicator into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the adjunctive cardiovascular status indicator's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device. Final order.

The Food and Drug Administration (FDA or Agency) is classifying the cranial motion measurement device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the cranial motion measurement device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display. Final order.

The Food and Drug Administration (FDA) is classifying the continuous glucose monitor secondary display into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the continuous glucose monitor secondary display's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical Devices; Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System. Final order.

The Food and Drug Administration (FDA) is classifying the diurnal pattern recorder system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the diurnal pattern recorder system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

The MFER structure for coding medical signals in real time.

We present the structure of the MFER coder to store the medical signals in real time. The MFER is the rules to describe the file with tags the medical signal such as ECG, EEG, etc. However, because the MFER has the simple structure, and is stored as a file unit, it is difficult to process the signal with MFER rules in real-time. To do this, By storing the signal into small unit of time, it is possible to handle as if the signal is stored continuously. The structure of the presented MFER coder is verified in the results.

Standardization method for measurement of hydroxyurea by Ultra High Efficiency Liquid Chromatography in plasma of patients with sickle cell disease

Sickle cell anemia (SCA) is a recessively inherited disease characterized by chronic hemolytic anemia, chronic inflammation, and acute episodes of hemolysis. Hydroxyurea (HU) is widely used to increase the levels of fetal hemoglobin (HbF). The objective of this study was to standardize and validate a method for the quantification of HU in human plasma by using ultra high performance liquid chromatography (UPLC) in order to determine the plasma HU levels in adult patients with SCA who had been treated with HU. We used an analytical reverse phase column (Nucleosil C18) with a mobile phase consisting of acetonitrile/water (16.7/83.3). The retention times of HU, urea, and methylurea were 6.7, 7.7, and 11.4 min, respectively. All parameters of the validation process were defined. To determine the precision and accuracy of quality controls, HU in plasma was used at concentrations of 100, 740, and 1600 µM, with methylurea as the internal standard. Linearity was assessed in the range of 50-1600 µM HU in plasma, obtaining a correlation coefficient of 0.99. The method was accurate and precise and can be used for the quantitative determination of HU for therapeutic monitoring of patients with SCA treated with HU.

A anemia falciforme (AF) é uma doença hereditária recessiva caracterizada por anemia hemolítica crônica, inflamação crônica e episódios agudos de hemólise. Hidroxiureia (HU) é amplamente utilizada para aumentar os níveis de hemoglobina fetal (Hb F). O objetivo consiste em padronizar e validar um método para a quantificação de HU no plasma humano utilizando Cromatografia Líquida de Ultra Alta Eficiência (UPLC), a fim de determinar os níveis de HU em pacientes adultos com AF, tratados com HU. Utilizou-se coluna analítica de fase inversa (Nucleosil C18), fase móvel constituída por acetonitrila/água (16,7/83,3). Os tempos de retenção da HU, uréia e metiluréia foram respectivamente de 6,7, 7,7 e 11,4 minutos. Definiram-se todos os parâmetros do processo de validação. Para determinar a precisão e exatidão dos controles de qualidade utilizaram-se concentrações de 100, 740 e 1600 mM de HU no plasma, empregando como padrão interno a metiluréia. A linearidade foi avaliada no intervalo de 50 1600 mM de HU no plasma, obtendo-se coeficiente de correlação de 0,99. O método foi considerado exato e preciso e pode ser realizado com o propósito de determinação quantitativa de HU para monitorização terapêutica de pacientes com AF tratados com esse fármaco.

Medical devices; general hospital and personal use monitoring devices; classification of the ingestible event marker. Final order.

: The Food and Drug Administration (FDA) is classifying the ingestible event marker into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Dynamic biosignal management and transmission during telemedicine incidents handled by Mobile Units over diverse network types.

Early and specialized pre-hospital patient treatment improves outcome in terms of mortality and morbidity, in emergency cases. This paper focuses on the design and implementation of a telemedicine system that supports diverse types of endpoints including moving transports (MT) (ambulances, ships, planes, etc.), handheld devices and fixed units, using diverse communication networks. Target of the above telemedicine system is the pre-hospital patient treatment. While vital sign transmission is prior to other services provided by the telemedicine system (videoconference, remote management, voice calls etc.), a predefined algorithm controls provision and quality of the other services. A distributed database system controlled by a central server, aims to manage patient attributes, exams and incidents handled by different Telemedicine Coordination Centers (TCC).

A system of classification for the clinical applications of capnography.

We have attempted to list all the clinical applications of capnography described to date and classify them into categories. From an extensive Pubmed search 46 clinical applications of capnography were listed. To classify these we used six categories- Airway, Breathing, Circulation, Anesthetic Delivery Apparatus, Homeostasis and Non-perioperative. This list collates the described uses of capnography and this system of classification provides an aide-de-memoir in anesthesia education and simulation.

Multi-purpose HealthCare Telemedicine Systems with mobile communication link support.

The provision of effective emergency telemedicine and home monitoring solutions are the major fields of interest discussed in this study. Ambulances, Rural Health Centers (RHC) or other remote health location such as Ships navigating in wide seas are common examples of possible emergency sites, while critical care telemetry and telemedicine home follow-ups are important issues of telemonitoring. In order to support the above different growing application fields we created a combined real-time and store and forward facility that consists of a base unit and a telemedicine (mobile) unit. This integrated system: can be used when handling emergency cases in ambulances, RHC or ships by using a mobile telemedicine unit at the emergency site and a base unit at the hospital-expert's site, enhances intensive health care provision by giving a mobile base unit to the ICU doctor while the telemedicine unit remains at the ICU patient site and enables home telemonitoring, by installing the telemedicine unit at the patient's home while the base unit remains at the physician's office or hospital. The system allows the transmission of vital biosignals (3-12 lead ECG, SPO2, NIBP, IBP, Temp) and still images of the patient. The transmission is performed through GSM mobile telecommunication network, through satellite links (where GSM is not available) or through Plain Old Telephony Systems (POTS) where available. Using this device a specialist doctor can telematically "move" to the patient's site and instruct unspecialized personnel when handling an emergency or telemonitoring case. Due to the need of storing and archiving of all data interchanged during the telemedicine sessions, we have equipped the consultation site with a multimedia database able to store and manage the data collected by the system. The performance of the system has been technically tested over several telecommunication means; in addition the system has been clinically validated in three different countries using a standardized medical protocol.

Detecting relationships between physiological variables using graphical models.

In intensive care physiological variables of the critically ill are measured and recorded in short time intervals. The proper extraction and interpretation of the information contained in this flood of information can hardly be done by experience alone. Intelligent alarm systems are needed to provide suitable bedside decision support. So far there is no commonly accepted standard for detecting the actual clinical state from the patient record. We use the statistical methodology of graphical models based on partial correlations for detecting time-varying relationships between physiological variables. Graphical models provide information on the relationships among physiological variables that is helpful e.g. for variable selection. Separate analyses for different pathophysiological states show that distinct clinical states are characterized by distinct partial correlation structures. Hence, this technique can provide new insights into physiological mechanisms.

Medical devices; apnea monitor; special controls. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to create a separate classification for the apnea monitor. The device currently is included in the generic type of device called breathing frequency monitors. The apnea monitor will remain in class II, but will be subject to a special control. The special control is an FDA guidance document that identifies minimum performance, testing, and labeling recommendations for the device. Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a "new" apnea monitor will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control. FDA is taking these actions because it believes that they are necessary to provide reasonable assurance of the safety and effectiveness of the apnea monitor.

Use of a physiologic scoring system during interhospital transport of pediatric patients.

OBJECTIVE: To determine the incidence of physiologic deterioration in critically ill and injured pediatric patients during interhospital transport with air and ground ambulance DESIGN: Prospective, descriptive study SETTING: All children were treated in regional hospitals and then transported to a pediatric tertiary care center. PATIENTS: Children (n = 100) with a median age of 1.4 years (range 1 week to 18 years) MAIN RESULTS: Three sets of physiologic scores were calculated: at the time of referral, on departure from the referring hospital, and arrival at the tertiary care center. The incidence of significant physiologic deterioration based on the calculated physiologic scores was 5.6% (n = 4) during ground and 3.4% (n = 1) during air ambulance transports. Critical events occurred in 15% of ground and 31% of air ambulance transports. CONCLUSION: No difference existed in the incidence of adverse events or physiologic deterioration when air ambulance transports were compared with ground ambulance transports for critically ill children by our team. The physiologic scoring system we chose is simple and easy to use for quality assurance.

Classification of epileptic seizures: a comparison of two systems.

PURPOSE: Extensive experience with video-EEG seizure monitoring, notably in the setting of epilepsy surgery programs, has exposed the limited value of the current International Classification of Epileptic Seizures (ICES) for providing relevant localizing information. To overcome this limitation, a Semiologic Seizure Classification (SSC) has recently been proposed. This study aimed to assess and to compare the usefulness and reliability of both systems in the setting of a tertiary epilepsy center. METHODS: Three epileptologists independently reviewed video-taped seizures, randomly selected from the archive of the Epilepsy Monitoring Unit. They were blinded to the EEG findings and final diagnosis and classified all seizures according to both classifications. RESULTS: One hundred thirty-eight seizures from 60 patients (age range, 2-59 years) were reviewed (maximum, three seizures per patient). Fifty-five seizures from 20 patients were recorded in the setting of presurgical evaluations, and the remainder as part of regular diagnostic evaluations. The average interobserver agreement was higher for SSC (63.3%, kappa = 0. 56) than for ICES (38.6%, kappa = 0.41). Some categories of SSC, such as hypermotor or automotor, had the best interobserver agreement, and were strongly correlated with the anatomic localization of the seizures (frontal and temporal lobe, respectively). All reviewers agreed that SSC provided a better description of the seizures than did ICES, in 60% of the patients. CONCLUSIONS: SSC provides a more comprehensive picture of epileptic seizures than does ICES, notably in patients with localized epilepsy syndromes, and appears to be very useful and reliable, particularly in the setting of specialized epilepsy centers.

Summary of ICD-9-CM Coordination and Maintenance Committee meeting.

The ICD-9-CM Coordination and Maintenance Committee, cosponsored by the National Center for Health Statistics (NCHS) and the Health Care Financing Administration (HCFA), recently met in Baltimore, MD. Donna Pickett, RRA (NCHS), and Patricia Brooks, RRA (HCFA), cochaired the meeting. Proposed modifications to ICD-9-CM were presented and are summarized below. Unless otherwise indicated, the audience generally supported the proposed changes.