Researchers Submit Patent Application, “Synchronous Clinical Data Collection, Analysis and Reporting System and Method Therefor”, for Approval (USPTO 20230064524): Patent Application

2023 MAR 22 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- From Washington, D.C., NewsRx journalists report that a patent application by the inventors Barnacka, Anna (Cambridge, MA, US); Panchal, Jal Mahendra (Somerville, MA, US), filed on August 31, 2022, was made available online on March 2, 2023.

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: “Clinical trials and research of medical devices have well-defined protocols. These protocols keep the patient safe during testing, protect the data obtained during the trial in accordance with patient privacy and data security concerns, and separate the data obtained by each medical device under test (DUT) from data obtained by other medical devices used during the clinical trial. The collection of medical devices and other equipment used during a clinical trial or research session forms a clinical trial system.

“A clinical research team of individuals operate as administrators of the clinical trial/research sessions. The administrators operate the medical devices, monitor the patient, and manage the recording and collection of the data obtained from the medical devices.

“The clinical trials take place at medical facilities such as hospitals and clinics. Typically, a dedicated laboratory space or room within the medical facilities is established for each type of clinical trial. In one example, clinical trials of DUTs that are designed to monitor cardiovascular function of test patients often occur in cardiac catheter laboratories (“cath lab”).

“During each clinical trial/research session, the administrators control the overall clinical research/trial and its operation, while on-site representatives for the DUTs control and manage the operation of the DUTs under the guidance of the administrators. These representatives are also known as operators of the DUTs.

“The medical devices of the clinical trial systems (other than the DUTs) are also known as reference clinical devices. These reference clinical devices monitor vital signs of test patients and typically collect data from one or more bodily systems of the patient during the clinical trial or research session. These reference clinical devices are standardized and installed at the laboratory prior to introduction of the DUTs. Examples of reference clinical devices include an electrocardiogram system (ECG system) to monitor heart rate and respiration, one or more catheter systems to monitor blood pressure, and one or more X-ray systems.

“A clinical patient monitoring and data recording system (“clinical data recorder”) is used to collect and record the data obtained by and sent from the reference clinical devices, while a separate recording system is typically used by the operators of the DUT(s) to collect and record the data obtained by and sent from the DUTs. These separate recording systems provide a boundary between the data obtained from the reference clinical devices and the data obtained from the DUT(s). Here, the data obtained is “raw” and does not identify the patient, which is important for accessibility and compliance with data privacy and security regulations. Examples of data privacy regulations include the General Data Protection Regulation 2016/679 (“GDPR”) adopted by the European Union, the California Consumer Privacy Act (CCPA) of 2018 in California in the United States, and the nationwide Health Insurance Portability and Accountability Act (HIPAA) introduced in the United States in 1996.

“The clinical data recorder has interfaces for each reference clinical device and monitors and records time-stamped analog output data from each reference clinical device. The clinical data recorder also typically has a defibrillator interface that provides a defib sync port signal that is normally used as a timing reference for an external defibrillator The external defibrillator can restore normal operation of the test patient’s heart in the unlikely event that the patient’s heart stops beating or beats erratically during the clinical trial.

“One example of a clinical data recorder is a General Electric (GE) Transport Remote Acquisition Monitor (TRAM). The GE TRAM is a medical grade computer system with a chassis-based design that accepts one or more modular computer processing boards. These modular computer processing boards insert into slots of the chassis and are also known as modules. The chassis also has a backplane that allows sharing of power, control signals and some data between the modules.

“Each module in the GE TRAM has a specific purpose. Most of the modules are feature-specific modules that are designed to interface with and support collection and recording of data from a specific reference clinical device, while other modules provide capabilities that span across multiple modules. Examples of feature-specific modules include multi-lead/multi-wire ECG, invasive blood pressure (BP) measurement using catheters, pulse oximetry (“SpO2”), impedance for respiration, and non-invasive blood pressure (“NIBP”) modules. The GE TRAM also has a defibrillator module with a configurable defib sync port.

“The clinical data recorder records the time-stamped analog output data from each reference clinical device, and includes the time-stamped analog output data from each reference clinical device into an output dataset known as a clinical dataset.

“The clinical data recorder is also designed to interface with an electronic records management system. The records management system is either installed at the medical facility where the clinical trial occurs or is accessible externally via a secure network connection. The records management system stores the time-stamped clinical datasets sent from the clinical data recorder and maintains security and privacy over the data. One example of a records management system used at many US hospitals and clinics is Epic EHR.

“The separate recording system used by the operators of the DUT(s) to collect and record the data obtained by and sent from the DUTs is also known as a DUT recorder. A separate DUT recorder is used for each DUT device.

“Each DUT recorder has interfaces to collect and record the data obtained by and sent from each DUT, also known as DUT datasets. However, the DUT recorder cannot access the medical facility’s records management system. As a result, the DUT datasets and the clinical dataset are kept separate.”

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors’ summary information for this patent application: “The existing clinical trial/research systems have limitations. In general, each of the reference clinical devices and the DUTs have different levels of response and delay when obtaining their signals, and obtain their signals using a separate internal reference clock. As a result, the signals within the clinical dataset typically have different timestamps and are not synchronized with respect to one another, and the signals within the DUT datasets typically have different timestamps and are not synchronized with respect to one another. Correspondingly, the signals across the clinical dataset and the DUT datasets are thus also not synchronized.

“The lack of signal synchronization within the clinical datasets and within each of the DUT datasets, and the lack of signal synchronization across the clinical dataset and the DUT datasets, can affect the usability of the data collected and the results/conclusions reached upon analyzing the data. The administrators of the existing clinical trial/research systems collect the datasets after the research/trial has completed, analyze the datasets, and provide results in response to the analysis. However, the analysis and results are often significantly impacted by the lack of signal synchronization/differences in timestamps among the signals, especially as the time differences between the signals increases. This lack of signal synchronization/level of mis-synchronization also cannot be cured after data collection. As a result, the usability of the data collected (and thus the accuracy of results/conclusions reached) can be reduced, which challenges the ability of the DUT manufacturers to develop accurate algorithms and solutions.

“Another limitation is that during the research/trial, the operators of the DUTs usually have access only to the live catheter data from the catheter system reference clinical device. The operators of the DUTs not only do not have access to other clinical device data during the trial (such as the ECG signals from the ECG system), the operators also cannot access the recorded clinical datasets created or otherwise produced by the clinical data recorder after the research/trial has concluded. As a result, the operators of the DUTs and other stakeholders must wait weeks or months for the administrators to analyze and interpret the DUT datasets in light of the clinical dataset in order to make any conclusions concerning the efficacy of the DUT(s).

“Moreover, as discussed previously, the lack of signal synchronization/level of mis-synchronization within the clinical dataset and the DUT datasets themselves can affect the analysis performed upon the datasets and the results reached by the administrators. For example, experimentation has shown that time differences between signals from different clinical devices within the clinical dataset can be on the order of seconds. At the same time, human physiology can change significantly between heartbeats. While the heartbeats are on the order of seconds, there are some cardiac events or measurements that occur between or across heartbeats that are on the order of tens milliseconds (mSec). In one example, the variability between heartbeats, also known as heart rate variability (HRV), is typically on the order of tens of mSec, while resting BP has been shown to change as much as 20 mmHG within a period of less than three seconds. Poorly synchronized datasets could cause the researchers to either not detect these events, or fail to detect correlations in multiple signals when these events occur.

“Still another limitation is that the results of the clinical trials are typically limited to a small set of plotted images of the DUT datasets and the clinical dataset that the administrators of the clinical research/trial deem as relevant. Such a limited set of images provides an imperfect and incomplete assessment of the capabilities and efficacy of the DUTs.

“It is therefore an object of the present invention to provide a clinical data collection, analysis and reporting system (“clinical data system”) that synchronizes the DUT datasets with the clinical datasets, in real-time, during the clinical trial or research session. The proposed clinical data system also allows remote personnel such as other researchers and DUT stakeholders to access the clinical datasets and the DUT datasets in real-time and communicate with personnel in real-time during the clinical research/trial. Here, the remote personnel can assess the quality of the datasets, and based upon the clinical datasets and/or the DUT datasets, provide interactive feedback and instruction to the on-site administrator of the clinical data system and the operators of the DUTs concerning valid use and operation of the DUTs and the reference clinical devices to achieve best quality or acceptable data.

“For this purpose, in one embodiment, the proposed clinical data system employs a defibrillator synchronization output port (“defib sync port”) signal of the clinical data recorder to use as a reference signal. This reference signal is used to synchronize the signals sent from each DUT and thus synchronize the DUT dataset for each DUT. The same reference signal is also used to synchronize the signals in the clinical dataset. Preferably, the reference signal is/are ECG signals from an ECG system reference clinical device. For this purpose, the clinical data recorder is configured such that its defib sync port provides the ECG signals as a reference signal.

“The clinical data recorder also includes the defib sync port reference signal in the clinical dataset. In this way, the same reference signal within the clinical dataset can be used to synchronize the signal data in each DUT dataset collected over the same time period as each clinical dataset, in real-time, during the clinical trial.

“The proposed clinical data system also provides the operators of the DUT(s) with access to the clinical dataset both during and after the clinical research/trial. In this way, the operators of the DUT(s) can analyze their DUT datasets with the clinical dataset independently from the administrators and draw their own conclusions regarding the efficacy of the DUTs. Moreover, the analysis and conclusions can take place over possibly days or hours rather than months, as in existing research or clinical trial/study systems. Additionally, the remote personnel can also access the clinical dataset and the DUT dataset(s).

“At the same time, the proposed clinical data system maintains the data security and privacy of the clinical datasets as in the existing clinical trial systems. This is because the clinical datasets include data that carries no identifiable information that directly ties the data to individuals. Rather, the data is anonymized/tagged only with unique alphanumeric strings. Only the records management system includes the mappings between the alphanumeric strings in the data and the identities of the test patients. Though the proposed clinical data system allows operators of the DUTs to access the clinical datasets during the clinical trial, the clinical data system cannot access the records management system of the clinical setting. As a result, data security and patient privacy is maintained.

“The proposed clinical data system has many advantages over the existing clinical trial systems. In one example, the DUT dataset from each DUT is/are synchronized with a reference signal of the clinical datasets, in real-time. Another example is that the operators of the DUTs have access to all data collected during the clinical trial. Not only can the researchers make more informed conclusions regarding the efficacy of their DUTs, but the analyses performed and any conclusions reached can be performed independently from the administrators of the research/trials and be completed in possibly weeks or even days. In yet another example, the clinical datasets and the DUT datasets can be scrubbed to eliminate even the alphanumeric identifiers. This allows the data to be shared for peer review and independent confirmation without breaching patient privacy and data security protocols. In still other examples, the reference signal can be used to calibrate the other clinical devices used during the clinical trial, and to also calibrate each DUT.

“In addition to clinical trial/research sessions, the proposed clinical data system can also be used to collect, synchronize, calibrate and record signal data from reference clinical devices and from DUT devices during surgical and other medical procedures. For this purpose, the broader term “medical setting” refers to any of the following: clinical trial setting, research setting, surgical/hospital setting, laboratory setting, outpatient setting or other setting in which the proposed clinical data system can operate. The duration of time that the proposed clinical data system operates at a medical setting is known as a medical session.”

There is additional summary information. Please visit full patent to read further.”

The claims supplied by the inventors are:

“1. A synchronous clinical data collection, analysis, and reporting system (“clinical data system”), the clinical data system comprising: a clinical data recorder that collects and records signal data of a patient obtained by and sent from reference clinical devices during a medical session, synchronizes the signal data from each of the reference clinical devices using a reference signal, and creates clinical datasets that include the signal data from each of the reference clinical devices and the reference signal; one or more devices under test (DUT) that each obtain signal data from the patient during the session, wherein each DUT synchronizes its signal data using the reference signal and creates DUT datasets that each include the signal data from each DUT and the reference signal; and a computing unit that receives the clinical datasets from the clinical data recorder and the DUT datasets sent from each of the DUTs, computes a normalized reference signal for each DUT dataset, and synchronizes the signal data of each DUT dataset with the signal data of the clinical datasets using the normalized reference signal computed for each DUT dataset.

“2. The clinical data system of claim 1, wherein the clinical data recorder is configured to obtain the reference signal from the signal data of one of the reference clinical devices.

“3. The clinical data system of claim 2, wherein the reference signal from the signal data of one of the reference clinical devices is/are ECG signals of an ECG system reference clinical device.

“4. The clinical data system of claim 1, wherein the clinical data recorder is configured to use the reference signal from the signal data of one of the DUTs.

“5. The clinical data system of claim 4, wherein the reference signal from the signal data of one of the DUTs is/are earbud signals detected by and sent from an earbud system DUT.

“6. The clinical data system of claim 1, wherein the computing unit records the DUT datasets and provides an interface that enables operators of the DUTs to access anonymized versions of the DUT datasets in real time during the session and after all DUT datasets have been received.

“7. The clinical data system of claim 1, wherein the computing unit provides an interface that enables an administrator of the system to access anonymized versions of the clinical datasets in real time during the session and after all clinical datasets have been received.

“8. The clinical data system of claim 1, wherein the computing unit computes a normalized reference signal for each DUT dataset by identifying DUT datasets and one or more clinical datasets obtained over substantially a same time period, and calculating and subtracting delays between the reference signal of the clinical datasets and the reference signal of each DUT dataset obtained over substantially the same time period, the result of which is/are the normalized reference signal for each DUT dataset.

“9. The clinical data system of claim 1, wherein the computing unit calibrates the signal data of each DUT dataset upon determining that delays between the signal data and reference signal of each DUT dataset collected over a same time period are above a threshold value.

“10. The clinical data system of claim 1, wherein when the reference signal in each DUT dataset is an ECG signal from an ECG system, the computing unit either calibrates each DUT dataset upon determining that delays between the signal data and reference signal of each DUT dataset collected over a same time period are above a threshold value, or upon determining that delays between the signal data and the reference signal of each DUT dataset collected over the same time period change more than a threshold amount over a range of successive heartbeats in the ECG signal as the reference signal.

“11. The clinical data system of claim 10, wherein the computing unit calibrates each DUT dataset by either identifying a signal feature in or introducing a signal feature into both the signal data and the reference signal of each DUT dataset collected over the same time period, and then identifying a difference in time when the signal feature occurs in the signal data and in the reference signal.

“12. The clinical data system of claim 1, wherein the computing unit calibrates each clinical dataset upon determining that delays between the signal data and reference signal of each clinical dataset are above a threshold value.

“13. The clinical data system of claim 1, wherein when the reference signal in each clinical dataset is an ECG signal from an ECG system, the computing unit either calibrates the clinical dataset upon determining that delays between the signal data and reference signal of each clinical dataset are above a threshold value, or upon determining that delays between the signal data and the reference signal of each clinical dataset change more than a threshold amount over a range of successive heartbeats in the ECG signal as the reference signal.

“14. The clinical data system of claim 13, wherein the computing unit calibrates each clinical dataset by either identifying a signal feature in or introducing a signal feature into both the signal data and the reference signal of each clinical dataset, and then identifying a difference in time when the signal feature occurs in the signal data and in the reference signal of each clinical dataset.

“15. A synchronous clinical data collection, analysis, and reporting method, the method comprising: collecting signal data of a patient obtained by and sent from reference clinical devices during a medical session, synchronizing the signal data from each of the reference clinical devices using a reference signal, and creating clinical datasets that include the signal data from each of the reference clinical devices and the reference signal; collecting signal data of the patient obtained by and sent from one or more devices under test (DUT) during the session, synchronizing the signal data from each DUT using the same reference signal, and creating DUT datasets for each DUT that include the signal data from each DUT and the reference signal; computing a normalized reference signal for each DUT dataset, based on differences in time between the reference signals of each DUT dataset collected over a same time period and the reference signals of clinical datasets collected over the same time period as each DUT dataset; and synchronizing the signal data of each DUT dataset with the signal data of the clinical datasets using the normalized reference signal computed for each DUT dataset.

“16. The method of claim 15, further comprising obtaining the reference signal from the signal data of one of the reference clinical devices.

“17. The method of claim 15, further comprising obtaining the reference signal from the signal data of one of the DUTs.

“18. The method of claim 17, wherein obtaining the reference signal from the signal data of one of the DUTs comprises obtaining the reference signal from earbud signals detected by and sent from an earbud system DUT.

“19. The method of claim 15, further comprising recording the DUT datasets and providing an interface that enables operators of the DUTs to access anonymized versions of the DUT datasets in real time and after all DUT datasets have been recorded.

“20. The method of claim 15, further comprising recording the clinical datasets and providing an interface that enables an administrator to access anonymized versions of the clinical datasets in real time and after all clinical datasets have been recorded.”

For additional information on this patent application, see: Barnacka, Anna; Panchal, Jal Mahendra. Synchronous Clinical Data Collection, Analysis and Reporting System and Method Therefor. U.S. Patent Application Number 20230064524, filed August 31, 2022 and posted March 2, 2023. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(20230064524)&db=US-PGPUB&type=ids

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