Patent Application
20150127375
The present invention relates generally to database management systems. More particularly, embodiments of the invention provide methods and systems for cloud-based medical database management.
In a hospital or hospital system, clinical parameters/data (such as diagnosis, blood test results, visual acuity, image studies, reports of clinical procedures, medication administered or surgical intervention) are stored digitally in a hospital database. Such database is usually included in an HIS (Hospital Information System or Health Information System). Besides supporting the daily clinical operation of the hospital, medical primary investigators (PI) often access the database to monitor the progress of a patient or to conduct formal clinical studies.
Thus, large amount of clinical data in the database can be analyzed to identify at-risk patients, track clinical outcomes, performance measurement and management, clinical decision making at the point of care, and research on a large scale. However, conventional hospitals data management systems often provide only relatively simple database functions such as health care data retrieval for individual patients.
The inventors have observed that conventional health care databases have many drawbacks. The conventional hospital computer system may allow the health care providers to access the clinical data stored in HIS, but only in a very limited way. Hospitals or health care organizations continue to struggle with extracting and analyzing the wealth of digital information locked within the existing silos of the hospital systems. For example, the health care provider can only retrieve clinical data for a particular patient, but the database usually is not amenable for in depth clinical data analysis. For example, the system usually does not perform any inter-patient comparison (e.g. the blood pressure of all the patients before and after taking drug x). If the number of patients is large (e. g. >10000), then the data retrieval would be very cumbersome and time consuming. For example, an extensive clinical study may need many assistants and take a long time to retrieve all the data to make an Excel table for further calculation. Thus, there is a need for easy-to-use interfaces with data mining and statistical analysis capability to analyze digital clinical data to improve health care outcome and reduce health care cost.
Embodiments of the present invention provide a cloud-based system to link cloud-based applications to a conventional hospital database. In an embodiment, the cloud-based system provides a method for the user to define a private customized database. The data template and protocol can be tailored for a specific application, for example, a clinical study. The cloud-based system is linked to the hospital database, so that existing or new data in the hospital database can be selected and stored in the user's private database in the cloud. Private databases on multiple cloud-based systems, which can include clinical data from different hospitals or different countries, can be merged for a multicenter study. The cloud-based system can provide on-line database storage and backup of clinical data for a large number of patients. Data analysis, including analysis for clinical studies, can be carried out efficiently and, in some embodiments, automatically. Analysis results can be provided timely and cost-effectively. Furthermore, the cloud-based system allows the user access via different devices, such as windows laptop, iPad, or even mobile smart phones.
According to some embodiments of the present invention, a method is provided for a user, such as a medical research primary investigator (PI), to manage patient clinical database. The method allows the primary investigator to specify and build a private clinical database on a cloud-based system in his specific format and structure. The existing clinical data in a database in a hospital information system can be extracted and converted to the new format and new structure and stored in a private database in the cloud-based system. A hospital server is coupled to the hospital database and is configured to allow the user to enter new clinical data in the new format and stored in the cloud-based private database. In some embodiments, the new data is also entered in the existing database in the hospital information system to maintain continuity in the operation of the hospital information system.
According to an embodiment of the present invention, a method for managing a private database in a cloud-based system includes providing a first database protocol that includes a first data template for a first database structure for a first database provided by a cloud-based system, and entering new data according to the first data template. The new data is entered into the first database in the cloud-based system according the first database protocol, and the new data is into the second database according to a second database structure that is different from first database structure. The method also includes extracting data from the second database according to a selection criterion in the first protocol, wherein the extract data is entered into the first database in the cloud-based system in the first database structure according to the first database template. The method can also include analyzing the data in the first database using the web-based portal provided by cloud-based system.
According to an embodiment of the present invention, a method for a user to manage a private database in a cloud-based system includes specifying a first database protocol that includes a first data template for a first database structure using a web-based portal provided by the cloud-based system, which includes a first database for the user containing data in the first database structure. The first database protocol is entered into a server that is coupled to a second database system that contains data arranged in a second database structure that is different from first database structure, the server being coupled to the cloud-based system by a network connection. New data is entered in the server according to the first data template, wherein the server copies the new data into the first database in the cloud-based system via the internet portal according the first database protocol, and the server enters the new data into the second database according to the second database structure. The method also includes selecting data from the second database according to a selection criterion in the first protocol using the server, wherein the server enters the selected data into the first database in the cloud-based system in the first database structure according to the first database template. The method can also include analyzing data in the first database using the web-based portal provided by the cloud-based system.
In a cloud-based system, a method for a user to manage patient clinical database includes providing a first clinical database protocol that includes a first clinical data template suitable for a clinical study using a web-based portal provided by a cloud-based system, the cloud-based system including a private database configured by and for the primary investigator himself in a first medical database structure. The method includes entering the first clinical database protocol into a hospital server that is coupled by a network connection to the cloud-based system and is also coupled to a hospital information system (HIS). The HIS contains patient medical data arranged in a second medical database structure that is different from first medical database structure, said hospital server being configured to convert patient data between the first and the second medical database structures. The method includes performing one or more of the following tasks.
A further understanding of the nature and advantages of the present invention may be realized by reference to the remaining portions of the specification and the drawings.
As shown in
In some embodiments, when computer programmable instructions or codes are retrieved from a storage medium and executed by a processor in the cloud based system and the server, certain database management functions are performed. Some examples are described below.
In some embodiments, computer codes in the cloud-based system, when retrieved from the storage medium and executed by the one or more processors, performs one or more of the following functions:
According to an embodiment of the present invention, a method is provided for a user to manage a private database in a cloud-based system. First, a user provides a first database protocol that includes a first data template for a first database structure for a first database 124 provided by a cloud-based system 100. A server 160 is coupled to a second database system 162 that contains data arranged in a second database structure that is different from first database structure. The server is also coupled to the cloud-based system. The user can enter new data according to the first data template, and the new data is entered into the first database 124 in the cloud-based system according the first database protocol. In some embodiments, the new data is also entered into the second database 160 according to the second database structure. In some embodiments, existing data from the second database is extracted according to a selection criterion in the first protocol. The extract data is entered into the first database 124 in the cloud-based system 100 in the first database structure according to the first database template. The user can analyze the data in the first database 124 using the web-based portal 132 provided by cloud-based system 100. Depending on the embodiments, the user can enter the first database protocol using the web-based portal provided by the cloud-based system or using the server. Similarly, in some embodiments, the user can enter the new data using the web-based portal provided by the cloud-based system or using the server. Further, the data conversion can be performed either by the cloud-based system or the server.
According to another embodiment of the present invention, a method is provided for a user to manage a private database in a cloud-based system. First, a user specifies a first database protocol that includes a first data template for a first database structure using a web-based portal provided by the cloud-based system. The cloud-based system includes a first database 124 for the user that contains data in the first database structure. Then, the first database protocol is provided to server 160 that is coupled to a second database system 162 that contains data arranged in a second database structure that is different from first database structure. In some embodiments, server 160 is configured to convert data between the first and the second database structures. Then, the user can enter new data into server 160 according to the first data template, wherein the server enters the new data into the first database 124 in the cloud-based system according the first database protocol, and the server enters the new data into the second database 160 according to the second database structure. In some embodiments, the server 160 is also configured to select data from the second database according to a selection criterion in the first protocol. The server then enters the selected data into the first database 124 in the cloud-based system 100 in the first database structure according to the first database template. The user can analyze the data in the first database 124 using the web-based portal 132 provided by cloud-based system 100.
As shown in
According to some embodiments of the present invention, a method is provided for a user, such as a medical research primary investigator (PI), to manage patient clinical database. The method allows the primary investigator to build a private clinical database on a cloud-based system in his specific format and structure. The existing clinical data in a database in a hospital information system can be extracted and converted to the new format and new structure and stored in a private database in the cloud-based system. A hospital server is configured to allow the user to enter new clinical data in the new format and stored in the cloud-based private database. The new data is also entered in the existing database in the hospital information system to maintain continuity in the operation of the hospital information system.
An example of the method according to an embodiment is summarized in the flowchart in
Next, the clinical database protocol is entered into hospital server 240 that is coupled by a network connection 10 to the cloud-based system 210 and is also coupled to a hospital information system (HIS) 250. In the embodiment shown in
In an embodiment, the hospital server 240 is configured to convert patient data between the user's medical database structure and the hospital medical database structures. In order to facilitate the conversion, the user's clinical database protocol can include clinical parameters and designated labels, which correspond to labels in medical records in the hospital information system. For example, the clinical parameters may include one or more of the following entries.
Using the hospital server, the user can enter new patient clinical data in the user's clinical data template using the hospital server. The hospital server is configured to allow the user to enter new clinical data in the new format and stored in the cloud-based private database. In some embodiments, the new data is also entered in the existing database in the hospital information system to maintain continuity in the operation of the hospital information system. In an embodiment, the hospital server enters the new patient clinical data into the user's private database in the cloud-based system according to the user's medical database structure after removing the patient's personal identification information.
In some embodiments, existing patient clinical data from the HIS can be selected and extracted for the clinical study according to a selection criterion in the first protocol using the hospital server. As an example, the selected patient clinical data is entered into the primary investigator's private database in the cloud-based system in the first medical database structure after the patient's personal identification information is removed, so the patient's privacy can be protected. The data in the user's private database can be used for analysis in a clinical study using the web portal provided by the cloud-based system.
In some embodiments, a system is provided for linking a HIS (Hospital Information System) with cloud-based applications. The cloud-based system can include multiple servers, computer programs for supporting cloud services, and application programs for preparing clinical studies, data analysis, graphing, etc. The cloud-based system can also provide each of multiple users with individual private storage space. Merely as an example, an application of such a cloud-based system can be described using the following clinical study scenario.
1. A primary investigator (PI) access a protocol form builder on the cloud via a website to define a protocol form, which is in HTML;
2. The PI accesses HIS, inputs the protocol form to HIS. A preprocessor in the hospital server converts the form to an internal form for accessing the HIS database;
3. The PI can input new patient data into HIS using his protocol form. The preprocessor checks to see if old data exists for this patient. The preprocessor collects all data, delinks the data (remove patient identification information for privacy concerns), then outputs all data related to this patient to PI's private database storage space on the cloud. The patient data is stored in the cloud in the format (protocol) specified by the PI without personal identification information. In some embodiment, the HIS database is updated according to old HIS format;
4. The PI can carry out data analysis on the cloud for clinical study.
In the system described above, the PI can define a different protocol for a different a clinical study of a different disease. The PI can also share data from different PI's. The cloud can also include provisions for security, authentication, etc.
In embodiments of the invention, an interface is provided to link the user's data template and protocol to the database in the hospital information system. In an embodiment, each clinical parameter stored in the hospital database is labeled with a specific code. For example, patient's blood pressure is labeled as 123, white cell count is labeled as 456, renal function test is labeled as 789, surgical treatment is labeled as xyz, patient taking drug x is labeled as X1, patient not taking drug X is labeled X0. Other clinical information, such as how long a cataract surgery takes, can also be extrapolated from data in the database, e.g., by labeling surgery commencement time as T1 and surgery ending time as T2 in the hospital database.
In embodiments of the invention, the form builder has an items bank, which can offer the PI an easier way to make a new form by choosing the items. Each item has its localization code in the HIS system, which allows the pre-set template to get the data from the HIS for each item. For example, visual acuity (VA) and intraocular pressure (IOP) are two common items for each study project in ophthalmology and for each visit of each patient. The VA and IOP have their localization code in the HIS. So, in the form builder, each new form can select the VA item and the IOP item from the item-bank. When the new form is sent into the HIS via the internet portal, the localization code of each item can be used to request the new value of VA and IOP from the HIS and fill the item automatically. Then, the new form filled with new values can be sent out to the cloud database for further computations. The items bank with the localization codes in the form builder can offer the principle investigator a new and easy way to build new forms with auto-function of data collection from the HIS. Furthermore, with the items bank with localization code, no modification of each hospital's HIS is necessary before the merge of data tables in multicenter study.
In some embodiments, the cloud-based system provides a protocol builder, in which a user, e.g., a health care provider, initiates a clinical study protocol and defines one or more clinical parameters to be included in the clinical study protocol.
As an example, a primary investigator initiates a clinical protocol in the cloud-based system to examine the effect of drug X on patient's blood pressure.
In some embodiments, the hospital server acts as a gateway for the hospital database for transmitting requests to and receiving data from the hospital database. In one embodiment, the hospital server access the data from the hospital database according to the method disclosed in U.S. Pub. No. 2012/0203817, which is incorporated herein by reference in its entirety.
The extracted clinical data is subsequently transmitted from the hospital server back to the cloud-based system for storage and analysis. The cloud-based system provides analytical tools for the user to perform the analyses needed for a clinical study. In some embodiments, the user-defined protocol can include analyses to be performed. In this case, the cloud-based system can automatically perform immediate statistical analysis of the extracted data. The analysis can include but is not limited to the mean, the median, the 95% confidence interval, survival analysis, or multivariate analysis, etc.
In some embodiments, security features can be incorporated into the system to protect patient's privacy and data security, as illustrated in
While certain embodiments of the invention have been illustrated and described, those skilled in the art with access to the present teachings will recognize that the invention is not limited to these embodiments only. Accordingly, it is to be understood that the invention is intended to cover numerous modifications, changes, variations, substitutions, and equivalents that will be apparent to those skilled in the art.
This application is related to in U.S. Pat. No. 7,822,976 and U.S. Patent Pub. No. 2012/0203817, the contents of both of which are incorporated herein by reference in their entirety.
