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A computer system and method is provided for mobile Internet (portable) digital data capture and data distribution. More than one project owner can share the same project schema.
1. A computer-implemented method for more than one project owner of a project to share the same project schema, the method comprising:
(a) providing a single project schema, the project schema having a plurality of objects and table structures which define the relationship between the objects, each of the objects having one or more attributes, each attribute having a value;
(b) defining a plurality of project owners for the project schema, wherein a plurality of users of a project are associated with each project owner, and the users of the project and the project owners are different entities;
(c) defining attribute values for each project owner of the project schema, wherein different project owners have one or more different attribute values while sharing the same project schema; and
(d) storing the attribute values in association with the respective project owners so that upon selection of a defined project owner, the project schema associates the appropriate values to the attributes.
2. The method of
3. The method of
4. An article of manufacture for more than one project owner of a project to share the same project schema, the article of manufacture comprising a computer-readable medium holding computer-executable instructions for performing a method comprising:
(a) providing a single project schema, the project schema having a plurality of objects and table structures which define the relationship between the objects, each of the objects having one or more attributes, each attribute having a value;
(b) defining a plurality of project owners for the project schema, wherein a plurality of users of a project are associated with each project owner, and the users of the project and the project owners are different entities;
(c) defining attribute values for each project owner of the project schema, wherein different project owners have one or more different attribute values while sharing the same project schema; and
(d) storing the attribute values in association with the respective project owners so that upon selection of a defined project owner, the project schema associates the appropriate values to the attributes.
5. The article of manufacture of
6. The article of manufacture of
7. A computer-implemented apparatus for more than one project owner of a project to share the same project schema, the method comprising:
(a) means for providing a single project schema, the project schema having a plurality of objects and table structures which define the relationship between the objects, each of the objects having one or more attributes, each attribute having a value;
(b) means for defining a plurality of project owners for the project schema, wherein a plurality of users of a project are associated with each project owner, and the users of the project and the project owners are different entities;
(c) means for defining attribute values for each project owner of the project schema, wherein different project owners have one or more different attribute values while sharing the same project schema; and
(d) means for storing the attribute values in association with the respective project owners so that upon selection of a defined project owner, the project schema associates the appropriate values to the attributes.
8. The apparatus of
9. The apparatus of
This application is a continuation of copending U.S. application Ser. No. 09/724,541 filed Nov. 27, 2000, now U.S. Pat. No. 6,834,285 the entire disclosure of which is incorporated herein by reference.
This application claims the benefit of U.S. Provisional Application No. 60/192,094 filed Mar. 24, 2000 entitled "COMPUTER SYSTEM FOR PORTABLE DIGITAL DATA CAPTURE AND DATA DISTRIBUTION."
Portions of the documentation in this patent document contain material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office file or records, but otherwise reserves all copyright rights whatsoever.
1. Field of the Invention
The present invention relates to a system for portable digital data capture and data distribution. More particularly, the present invention is related to an object-oriented computerized data capture and data distribution system that is employed to construct a portable digital data capture project from component objects and the like, to forward subsets of the project for the purpose of registering transactions, and to persistently save, recall, reconcile, and share the project. A real-world digital data capture and distribution project consists of four major components. First is the definition of the project: what data is to be captured, how input is to be made, what are the protocols for acceptable input, and how it is to be captured. Second is the logistics management of the project. This includes the functions and relationships for information such as: users with access to the project, user assignment details, forwarding project components to the field, managing changes and additions to the project, report distribution, and the like. Third is the capture of the data, which is conducted mostly by mobile personnel. Fourth is the design, development and distribution of reports on the data collected.
2. Background
A typical data capture and data distribution system employed in healthcare industry contexts uses a piecemeal software approach with many steps, each of which involves complex, redundant, and subjective human interaction on many trivial aspects of the process. In the definition stage of the project, text based forms for data entry are manually designed, developed and distributed in the field. The content of the forms and criteria for each data field in the forms are designed and then developed into a template, using software (word processor, spreadsheet, form maker, etc.). These forms may or may not have individual field restrictions for data entry. The software determines the format of these templates. The software with which the template was developed and the template itself are e-mailed or hand delivered and then loaded onto a device with memory and an operating system. In the data capture stage, a human completes the work according to their interpretation of the data collection criteria and protocol. The human then enters input into the text-based forms as a response. After a user makes input into the template, saves it with a file name, then distributes it by hand delivery, mail, e-mail or fax machine, responses are separately gathered from the field workers and data is entered into a database for storage, analysis, and development into reports. Reports on these responses are then separately designed, developed and distributed. These reports are distributed by hand delivery, mail, e-mail or fax machine. The text-based forms and the resulting response data are generally stored in any combination of the following: word-processing documents, spreadsheet documents, e-mails, and paper files, which may or may not have links to external databases. These external databases supply some data that the human user refers to when entering data into the text-based form. During each step of the data capture and distribution project using this system, many components of the project involve the management of logistics. Text-based forms are organized, copied and distributed, distribution of and changes to forms are tracked and the return of forms is managed. In addition, a manager checks for correctness of input by users; requests, manages, distributes and tracks what specific materials are to be reviewed or measured; distributes information on where these materials are located; etc. Even though some software and technology has been applied to data capture and data distribution, there are many opportunities for human error because the conventional system requires numerous human interactions with the project. Such errors include but are not limited to a loss of forms, distribution of out of date forms and then the collection of data with these forms, redundancies of assignments, misfiling, and data entry errors.
An important component of data capture and data distribution of the present invention is managing the logistics of data collection assignments. Logistics include but are not limited to the definition of an assignment, the tracking and managing of form creation/distribution, organizing the deployment of personnel and materials involved in a data capture project and distribution of assignments. Currently, a system for managing the logistics uses a separate piecemeal software approach to the problem as well. Logistics data is generally stored in any combination of the following: word-processing documents, spreadsheet documents, e-mails, and paper files, which may or may not have links to external databases. These external databases supply lists that are used for different components of logistics, such as assignments. The content of an assignment is predetermined. However, the format of assignments is determined by the software used (word processor, spreadsheet, form maker, etc.). E-mail or hand-delivery distributes the software with which the assignment format was developed, along with the assignment data. Managers who input and track assignment data access the software. Investigators in the field are distributed assignment data that pertains to them and refer to the assignment data, which is input in the data collection template. Any management or tracking of reports on the status of work assigned or the field workers assigned are separately developed, aggregated and then distributed by hand delivery, e-mail or fax machine as well.
To understand the conventional system and to visualize how a computerized system of the present invention has tremendous commercial value, an example of a pharmaceutical company's data capture and data distribution project is presented for the purposes of explanation. A pharmaceutical company (also referred to herein as "pharma") designs the templates and the protocols for input on each item that is to be measured or reviewed by clinical trial investigators during real-world data capture and data distribution in a Phase IV clinical trial. A data collection template that requires design, development, and distribution consists of the following items: question text; spaces to input responses; blanks for entry of demographic information about the review assignment (investigator name, address of the review, medical record number of the record being reviewed, date of the review, etc.) and directions about how to complete and save the template. To create a template, all of these components are developed into a word processing software or spreadsheet software template for data entry. Investigators receive the platform-dependent software from which the template was developed by hand delivery or e-mail. This software is loaded onto a specific hardware platform with memory, such as a laptop computer. In addition to the software, investigators receive by e-mail, mail, fax or hand delivery, and the text-based template for input of responses. Investigators also receive a separate list of medical record numbers of patients whose data is collected for the trial, along with a list of the doctors' names and addresses, whose patient records are to be reviewed as a part of this clinical trial. The data on these lists, which comes from external databases, are data entered by the investigator into the template as text response. When the investigator makes all inputs, the template is saved with a file name, then mailed, e-mailed, hand-delivered or faxed to pharma headquarters. At pharma headquarters, input is data entered into an external database and reports on these inputs are designed, developed and distributed by mail, e-mail, hand-delivery or fax.
In the example of a Phase IV clinical trial, assignment data consists of numerous items that all require definition, organization, management and tracking. These items include but are not limited to the name of the person requesting the review and the date of the request; the type of template to be used; the name of the doctor(s) and/or patient(s) record(s); and the complete demographic data, including suite number. Additional items include the investigator assigned and the date scheduled for the review; the completion date; and investigator or manager comments. To manage assignments, a template is developed for data entry of these items into word processing software or spreadsheet software. Investigators receive by hand-delivery or e-mail, the platform-dependent software from which the assignment templates were developed. This software is loaded onto a specific hardware platform with memory such as a laptop. Investigators refer to the assignment data that pertains to them and input part of the assignment data as a response in the data capture template. Investigators may also receive separate lists of medical record numbers along with separate lists of the doctors' names and addresses. The data on these lists are to be input into the templates as a separate response. When all inputs are made, the investigator inputs the date of completion into the assignment template, saves it with a file name, then e-mails, hand-delivers or faxes to pharma headquarters. At pharma headquarters, assignment data is removed from the template and entered into an external database. Mail, e-mail, hand-delivery or fax distributes management and tracking reports, prepared separately.
Such an approach has the advantage of supporting uniformity of data capture and assignment templates among users who are given the same templates. The software automates the scoring process, thus eliminating calculation errors. Also, additional data entry can be eliminated if responses can be imported from the software with which they were developed into an external database. In a system implemented with great attention to hardware and software version compatibility, data files created with one version of the software can be viewed by other versions of the software regardless of the hardware platform. This approach works well if questions, response choices, scoring, users, hardware, and assignments rarely change and quality assurance is performed on each of the data files. Quality assurance will ensure that data entered in responses are in accordance with predetermined criteria and that data entered from information on lists from external databases have been copied exactly, eliminating what appears as a duplicate entry but is actually not a duplicate entry.
A system such as described above lacks the speed, sophistication and flexibility to distribute, track, organize and manage changes or additions made to any or all of the components of the data capture/data distribution process at the same time without disturbing any aspect of the process. Components of a data capture and distribution process, such as logistics information management and data capture templates, are modified and added often, in order to fulfill complex data capture and data distribution needs. For example, during a clinical trial, investigators' inputs into templates may reveal that a change in the protocols for the templates is required. These changes to templates must be developed and then distributed quickly to all staff as required. Furthermore, multi-platform multi-software, and multi-version software support is a serious burden for the producer of the templates, the manager of the project logistics, the investigators making inputs, the staff creating and distributing reports, and the individuals to which the reports are distributed. All required reports are designed and developed as a separate component to the project.
To properly conduct data capture and data distribution, in healthcare or otherwise, a CDCDS must not just present separate templates for data entry of text responses and text assignment requests, which can be imported into external databases. Developing templates for each change to a data capture and distribution project is costly, time consuming, and labor intensive. Managing the logistics of distributing changes to data capture templates and assignment data to the appropriate personnel done with the above system is replete with errors and redundancies. Developing and distributing reports on the data collected is labor intensive, time intensive and programming intensive.
Data capture and distribution must be considered as a whole, from the design and development of project definition, to the data capture and the management of logistics for the project, and all the way through to distribution of reports. The data structures and the flow of information must support all of these components together and must remove redundant and trivial tasks, thereby streamlining and automating the process. There must be a complete representation of the relationships between all the components of the project. For example, the system used during a data capture and distribution project must incorporate the protocols for how input is made, what data is referenced as part of the inputs, what reports are needed, and what parts of the project are to be distributed to whom. In conjunction with these needs, there must be a complete representation and visualization of the relationships between the logistics components of the project. This would help prevent overlap in a situation where a site audit is being conducted. For example, if the manager can see that there are two doctors at the same site, then there is no need to do a site review of both doctors who share the site. In the conventional system, items are entered into a database separately without the ability to visualize other relationships between items in the database. Doctor A at 123 Main St. of the "Temple Medical Practice" will not be seen as grouped with Doctor B at 123 Main St. of "Temple Medicine." All of the project components and any changes/addition to the project components during the completion of a data capture and distribution project need to be speedily communicated to all designated parties. However, the most efficient strategy for organizing and storing data for capture and distribution does not just relate to the text alone but also relates to the properties, relationships, functions of and message with each of the components and to any of the parties involved.
The data types expressed in data capture and data distribution with the conventional piece-meal software approach vary widely between software (spreadsheets, word processing, file maker, etc). Therefore, it is not practical to express all of the possible combinations of data types within the software programs that are part of this system. Data from differing software may be simultaneously required in arbitrary combinations by a user. Therefore, multiple unrelated software specific tools cannot be employed. Human interaction is required to manually review and match the project requirements with staffing, information, and reporting needs.
A CDCDS must solve the problems described above by providing flexible programming tools that allow a user, having domain-specific expertise to develop programs and data structures into "schemas" relevant to any such domain data capture and data distribution project requirements. For example, in a phase IV clinical trial of a diabetic medication, certain programmed domain-specific components ("objects") will be integrated in a schema to capture information on dates of medication orders, and the information on test results. If a phase IV clinical trial were to be conducted on a biomedical device, different objects would be developed whereby the objects representing barcode data capture or device specific data from biomedical hardware can be integrated into a project. A user of the CDCDS employs one or more such schemas that can be combined and integrated in arbitrary combinations in conjunction with a single project. The users must be able to customize the combination of objects and their relationships and functions without additional programming. A user with project expertise is responsible for the identification of the objects and the relationship to other objects in an environment. A CDCDS must provide the ability to mark objects with certain functions specific to the project and mark the messages that will be passed between objects. A CDCDS must also reveal to users a visual representation of relationships in the project, in order to fully manage the flow of information and automate the organization and management of the logistics of a project. For example, in a Phase IV trial, investigators will receive a project subset forwarded to them for data input. The input made by investigators in this project subset is then reconciled with the project. During reconciliation, the investigator's project subset will be changed, reflecting updates made to the project by other users. An example of an update would be a change in protocols for the clinical trial. This, in turn, will affect changes in the data capture project as a whole, and these changes need to be forwarded to other users.
To accomplish such goals, the CDCDS must address the following concerns:
a. Data Portability and Longevity
In large organizations, groups involved in portable data capture and data/report distribution often work on multiple different types of mixed hardware and operating system configurations ("platforms"). Moreover, the life cycles of a project will often exceed the lifetime of one or more of such platforms. Accordingly, it is essential that CDCDS data that originates on one platform be useable on any other platform without translation. As a result, the CDCDS does not constrain the otherwise natural progression to the most cost effective computer systems. Furthermore, a project defined by such CDCDS data can be archived and reactivated years later on a new platform without any loss of integrity. Similarly, the type, the meaning, and the flow of the information in a project can change dramatically throughout the project life cycle. For example, the project has been changed to include signature capture during the data capture and distribution project because changes in industry regulations now requires this type of data capture. Or a question response type needs to be changed from a yes/no response choice to a yes/no/NA response choice because investigators reported the need for the additional response category after initial data capture in the field. It must therefore be possible to refine and revise the schemas that are used by the project (i.e., allow for "schema evolution") without jeopardizing the integrity of the previously created CDCDS data.
b. Data Integrity
A CDCDS stores valuable information. However, the value of the information can only be secure if the data capture and distribution project created by the program is standardized, reliable and accessible. To ensure that the data in a CDCDS project maintains internal consistency, it is necessary that such data always be accessed and modified by the same schemas that defined and created the project. It is therefore essential that schemas be easily accessed and ubiquitous with respect to the CDCDS project. Moreover, a CDCDS must minimize the need to produce and distribute copies of the CDCDS project. When multiple copies of the same project exist, any individual copy stands a greater chance of being rendered partially or wholly obsolete. For example, many investigators will access a data capture project, such as a phase IV clinical trial to input data at a remote site, during a review of medical records. In addition, managers will be adding assignment requests to the project and researchers will be modifying project protocols for the clinical trial. These changes need to be made without interrupting the workflow or the flow of information for any of the users. Another example of the need to ensure data integrity is when assignment requests from managers need to be forwarded to the appropriate investigators during the clinical trial. This data needs to be forwarded as part of a project subset. Simply supplying investigators with a blank field for data entry of assignment demographics and an assignment list does not guarantee that the data is consistent for the manager requesting assignments and for the investigator inputting data several different times at a remote site. Errors are rampant when a human user copies input between components of a project. When a report on this data is supplied, these data entry errors skew project results.
c. Data Accuracy
A CDCDS aids in the capture and distribution of data, whose accuracy is very important to an organization. For example, in a clinical trial, the Federal Drug Administration (FDA) monitors data very closely for correct or missing input. In order to reduce input error and thus ensure greater compliance with input protocols, a CDCDS must allow the researcher to incorporate a level of "intelligence", including the complex logic of protocols, within a project. This intelligence will restrict the user from inputting data that is not in accordance with protocols, or will prompt the user to choose a correct input. The logic programmed into a project may even supply input in response to prior input. Such complex logic in a project must go beyond the conventional systems' ability to restrict data entry by programming a field-input mask. A CDCDS must allow users to customize the design and development of projects that will advance to, skip over and complete input according to the protocols that have been programmed in the project, without further investigator input. For example, in the clinical trial, when the patient birth date is entered, the CDCDS-generated project will automatically input N/A wherever input does not pertain to that age range. Multiple protocols must be able to be developed into a tool and changes to protocols must be distributed easily. In addition, a CDCDS must guard against users twice entering what appears to be duplicate data to the user, yet is not an exact duplicate. For example, 123 Main St. is not a duplicate of 123 Main St (no period after St). In a clinical trial, patient records from these two addresses will not be collated together. Thus, repetitive information will be included in the project, making the project results inaccurate.
d. Large and complex data sets
The size of a typical CDCDS project can be quite large and complex and the project is often accessed using mobile hardware, which may have limited memory capacity. For example, a clinical trial project may require hundreds of inputs. The protocols programmed into a project may be complicated. In addition, complex logic that streamlines the workflow during data capture must be developed into the project. Additional inputs may be required based on previous input; inputs may be automatically repeated based on prior inputs; or an entirely new set of inputs must be made because of the previous input. The CDCDS must handle such large and complex projects efficiently and forward to the investigators only that subset of the project the investigator is working with. Investigators depend on the ability to access the project quickly and input the data quickly. The amount of information in a data capture project cannot be limited in a preset manner.
e. Aggregate Data Across Different Projects
Data captured by users on different real-world projects must be aggregated for the purpose of complex analysis of the data. For example, a tool that is used to capture data for a clinical trial of an asthma medication may contain data that must be referred to for a clinical trial of a cardiac medication. These clinical trial projects are often managed and performed by different users. In addition, the projects may refer to different schema programs. For example, one project captures specific data types, text, and bar code data while another project captures signatures. These very different projects need to be able to refer to each other. However, the user may not know the relationship between projects when a project is designed. The organization of the components of the projects and the data must allow for sharing between projects without the need for complex forensic analysis of the data tables and additional database programming to incorporate the two projects or share data between projects.
f. Many Simultaneous Users
A CDCDS project is typically shared simultaneously by many users within an organization. In a Phase IV clinical trial, the managers, staff development, investigators, and medical directors will be involved in a shared CDCDS project. Some users require access for querying and inspecting inputs only, but others need access to add to or modify the project. Accordingly, the CDCDS must ensure that changes to the project are properly coordinated and that the project is kept in a consistent state at all times.
g. Many Simultaneous Schemas
Data capture and data distribution projects typically involve collaboration among several disciplines, each being represented by one or more schemas. A CDCDS is expected to facilitate the integration of the information created by each of the departments to allow easy and consistent access to users in other departments. Therefore, a CDCDS must store and manipulate information defined by multiple schemas simultaneously. Further, it must be possible for one schema to reference information defined in and maintained by another schema within the data capture and distribution project.
h. Flexibility and Extensibility
A programmer, with the help of a project designer, typically refines a CDCDS to meet the changing needs of the user. Additionally, a CDCDS is refined by the end user to include user-defined extensions. Since every user has different requirements, the ability to customize the system "in the field" is essential. Project components change often and rapidly. A CDCDS must accommodate the user in making rapid changes to the project while tracking and managing the new project information so as to make it immediately accessible to the users in the field. In addition, as project components are added and manipulated by the users, the CDCDS must allow for the cross-referencing between project components for the purpose of viewing the evolution of the project and for viewing relationships between data capture and distribution projects. For example, in a clinical trial, the scoring methods, protocols and the response choices may change from project to project. It is valuable to track statistical similarities and the validity of data captured as part of a particular project.
i. Performance
Data capture and data distribution projects are characterized by complicated data sets that are accessible by users who are away from the office. Yet users demand speed and convenience when accessing a project. A CDCDS must be able to organize and store data such that access time to the data is optimized. For example, users at remote locations need access to changes in protocols without returning to the office and without interruptions in their data capture.
j. Ease of Use
A CDCDS user is presumed to be expert in a particular type of data capture. For example, in a diabetes project for Phase IV clinical trials, the user is knowledgeable about the disease state of diabetes and the design and development of this type of project. However, she is not necessarily a sophisticated computer user and is not likely to be willing to invest valuable time in extensive training. Furthermore, since multiple users from different departments will employ the same CDCDS, the expertise of the users will vary widely. Accordingly, use of a CDCDS must be simple, intuitive and familiar.
CDCDS Implementation
A successful CDCDS must incorporate a robust environment for programmers to implement schemas, must provide an easy-to-use environment for users to employ those schemas on real-world data capture and distribution projects, and must be easy to use in the field. Accordingly, the CDCDS implementation must include at least the following elements:
a. Schema Environment
Schemas must contain all necessary information to display, manipulate, revise, and query any data capture and distribution project. There cannot be any application-specific expertise built into the schema itself. Schemas must be portable so they can execute on any platform that the CDCDS can execute. Schemas must also be inseparable from the project, must be flexible and expandable without requiring the original source code for recompilation, and must execute efficiently. Due to the size of hand-held hardware (the optimal choice for users working in the field) and the complexity of a project, the routines that process this information must do so in an efficient manner. Schemas must also be able to evolve over time such that they can be revised and extended as new requirements arise.
b. Application Framework
In order to manipulate the schema objects for the development of a project, the objects must be presented to the user in a familiar and easy-to-use environment, or "application framework." The user interface programs must be portable across all platforms on which the CDCDS runs so those users can choose among appropriate platforms. However, the application framework itself must interact with the Native Operating System on which the framework executes. Such interaction must be transparent to the user.
c. Visualization of Data Relationships
In order to get the efficiency, speed and standardization of a CDCDS and reduce the amount of data capture needed to accomplish the goals of a project, the user must be able to visualize the relationships between all components of a project. Users must be able to easily visualize the overlap, redundancies and duplication in the project. This will prevent error, in a data capture project and thus increase the speed of the project. For example, in the phase IV clinical trial, a data capture tool has been accessed and input made during a medical record review for Doctor Marcus Welby at 123 Main Street, Small Town USA. A different staff member already completed a review for Marcus Welby MD at 123 Main Street, Small Town USA. Ordinarily, without visualization of the relationship between these two assignments, the second review for this doctor would be performed. There would be no way to visualize the redundancy because his name appears as a different name. The only way a user would verify a similarity is to look up the data by doctor and by site and compare these two entries. With relationships between data tables and queries organized to visually reveal all relationships in an assignment, a manager requesting the assignment will immediately see the redundancy and can take steps to correct it. Additional efficiencies, other than detecting the above error, can be experienced with the ability to visualize relationships. For example, in the same clinical trial, a review is completed for Doctor Welby that includes capturing data on compliance with facility safety regulations. On a different date, the same review is to be performed for a different doctor at the same facility. Ordinarily, without visualization of the relationship between these two assignments, which reveals overlap of the review of the facility, a new assignment would be requested and duplicate data will be captured. Additional problems may occur for the project. For example, a duplicate review for the same facility conducted by a different staff member may result in a different score for this facility. Although duplicate reviews are sometimes conducted for inter-rater reliability (work comparisons) between reviewers, an unknown duplicate review with a different score will foul the entire clinical trial. With the ability to visualize the duplication of assignments, a manager can choose to accept the duplication or not.
d. Distributed Components
To help prevent data obsolescence, a CDCDS must allow for having a certain subset of the project distributed out to users in the field. At the same time, a "live connection" to the distributed portion must be maintained in each project subset where it is referenced.
e. Tool Persistence
State information for project components must be maintained across editing sessions. Accordingly, objects must be dynamically reinstated each time the CDCDS is used to forward, view or manipulate the project.
f. Synchronous Data Reconciliation
When an object in a project is changed, other objects in the project may change as a result. A CDCDS must reveal relationships between objects so that those changes to objects downstream may be executed. If these changes result in an invalid or inconsistent project, the changes do not affect the data that has been captured. Multiple users throughout the life of a project access a CDCDS project on a real-time basis. Time delays must not be caused by the requirement to perform reconciliation between differing data sets that have been created by users. Certain sets of users access the CDCDS project to modify design and integration or to change other components of the project, such as logistics data. Other users access the project to input data. Each set of users will need to be updated with only the specific changes that affect their aspect of work in the project. The project will have changed many times and users in the field will need to receive these updates without having their workflow interrupted and without having to return to a central location for synchronization. This reconciliation of data in a CDCDS project must occur while other users access the project. Users, who are accessing and changing the design of the project, must be able to reconcile with users in the field so that all users have access to the latest changes without complex file naming conventions or without distribution of multiple versions of a CDCDS project. For example, in the clinical trial, certain users will be accessing the CDCDS project to input data, while other users access the CDCDS project to make changes in the criteria. Both users must be able to perform their tasks without loss of data or version control problems.
g. CDCDS Logic
A CDCDS project needs to aid users in the capture of data that is very important to an organization. These users have domain specific expertise, and they usually access a CDCDS project that pertains to their expertise. For example, in a clinical trial, nursing staff will input nursing data, while pharmacists will input pharmaceutical data. In certain cases, a machine such, as a medical device, will input body temperature readings. Users often need to remember input protocols, and protocols change often. For example in a clinical trial, specific protocols require an input if a patient is an adolescent. In addition, other protocols will require an input if an adolescent is a patient between the ages of 13-17. In order for inputs to be made correctly, an investigator must view the birth date of the patient, calculate the age of the patient, recall the protocol requirements and then make the appropriate input. A CDCDS project must aid the user by automatically referencing the designated protocol for input, then input automatically (i.e. enter a value automatically) and then reveal only the remaining input requirements. This complex logic in a CDCDS project needs to be flexible enough to change as the protocol changes. Since the CDCDS project automatically enters input, the user moves more quickly through the work and incorrect inputs are reduced. In addition, a data capture project may contain specific process protocols. For example, in a clinical trial, skipped input is not accepted. Input must be chosen from a limited list of choices. These process protocols must be programmed as part of the CDCDS project, which must be flexible and extensible enough to include changes to the process protocols that are immediately accessible to the users.
h. Project Management
A CDCDS must maintain the integrity of all project components. Accordingly, mechanisms are required to: lock portions of the components to regulate multi-user access; control revision access; create and manage parallel development to the same project; and prompt users who access the project to follow the logical requirements of a data capture project. In addition, changes from multiple users on the same project need to merge. A permanent identification of specific versions of constituent projects as contributing to a particular state of the project is required, and access to the database according to graduated security levels needs to be regulated.
The present invention comprises a computerized data capture and distribution system ("CDCDS") that electronically organizes all the components of a data capture and distribution project for design, analysis, manipulation, simulation, visualization, integration, decomposition, storage, retrieval and reporting. The present invention is highly suited for any environment where data is captured and distributed from/between remote locations or by mobile workers and reports are generated from the data. This invention would be useful in projects such as clinical trials, and pharmaceutical "detailing"; sales management; auditing sites, records, or inventory; conducting surveys; enrollment; and inputting and surveying data in medical records.
To address the requirements discussed above, the preferred embodiment of the present invention includes an object-oriented schema implementation programming language, a compiler, a linker, a run-time system, an object-oriented data transport schema, and a project database with data tables in specific relationships. The programming language is based on C++ (although Java and XML objects can be used) and is employed to write schema programs that are compiled using the compiler. The output of the compiler is an object file. The linker combines a group of object files into an executable program that is portable across many platforms, where each platform has a run-time environment tailored to that platform. The run-time environment contains only the absolute necessities to execute the application on that platform. Each program may also be a shared library. If so, the program exports references to these classes, functions, and variables. Other programs can have references to these classes, functions, and variables resolved at run-time. A program may both import and export references. That is, the program may use other shared libraries and may serve as a shared library for other clients. The object-oriented data transport schema is based on C++ (although Java, XML or other object-code can be used) programming language. The transport schema implements the various objects that are integrated into a data capture project, their functions, and how these objects are to function under specific transport circumstances. Specific relationships between tables in the project database are employed to allow visualization of data redundancy, overlap and errors. In addition, these table relationships are employed to visualize the shared commonality between items in any tables.
The present invention includes schemas for computerized creation, management, distribution and reporting of a portable data capture and data/report distribution project. The present invention also includes schemas for forwarding project subsets to workers in the field. During said transport, the versions of the project that are created or changed by users in the field are reconciled with the project database. In addition, specific data table relationships allow visualization of data that is entered and accessed for the creation, organization, tracking, management, and reporting of the logistics of a data capture and distribution project, along with any additional components.
The schema programs, the transport programs, and the specific data table relationships create, manage, distribute and report project components for a predetermined domain. Such domains include pharmaceutical, healthcare, insurance and other industries. The schemas represented by the schema programs represent multiple classes. Each defines a data type that can be placed in a CDCDS project, and defines how that object will interact with or affect other objects of the project. Objects or instances are created from each class as each object is placed in the project, marked for a specific use in the project, and marked for a specific type of reconciliation during data transport. This includes specifying the data variables, and the program code used to manipulate the variables.
Objects are stored in one or more repositories or "stores." Related stores are grouped into a "data capture and distribution" project which relates to a real-world project in healthcare or a real-world project in other industries. The CDCDS manages and stores any or all projects in a project database, on a networked server, with dial-up access so that multiple users both in the office at a desk and out in the field with mobile hardware can be given concurrent access.
First, all objects, their functions and how they will relate in a data capture and distribution project are added to the project database. The project database lists all the objects that are currently programmed in schemas, and which can be integrated as a project. The user then starts a session for the purpose of creating a data capture and data distribution project. The user will choose objects to integrate into a project and mark those objects with their functions and how these objects will relate to other objects. In addition, the user will mark how the functions of objects will relate to the functions of other objects. The following explanation describes how a user without programming skills, but who understands the nature of data capture and distribution projects in healthcare, creates a "project." The user accesses a set of forms, queries and macros written in Visual Basic language in the project database. These forms and queries restrict data entry in tables in a specific order and within certain parameters so that the project created in this manner meets the requirements of a real-world data capture and distribution project. Since a real-world project includes the management of users and differing levels of user access to the project, these forms, queries and macros help the user, who is creating the project, to set up the access requirements. The initial user, in addition to setting up access permissions, designates a second set of users—the field workers—to receive a forwarded project database. This allows the user who creates the CDCDS to mark objects for integration into a project and then to create entirely new projects by simply changing the relatedness of the objects. This eliminates the need to build entirely new projects from scratch.
Secondly, the users in the field begin a user session by executing a query of the project database to extract the subset of the project (for example, a number of related objects marked for their use) from the project database into a local database. The format of objects in the project database and in the local database is often different, so translation is necessary. This extraction is a long-term transaction to the project database. The user will have no further interaction with the project database during the user session. Changes or additions can be made to the project objects during an editing session by the first user, as well as by the field workers. These changes and additions can be posted to the project database at the end of a user session. Conflicts are reconciled by the transport schema that has been given designated functions and is carried out when users communicate with the project database at the end of a session.
Objects in a project database are defined and interpreted by the combination of instance data and class methods. Therefore, instance data cannot be interpreted without the related schema that corresponds to it. To maintain integrity of the project data, it must never be possible to encounter any instance without the corresponding schema. Due to this constraint, the CDCDS treats the programs that comprise a schema as a component of the project database, as with the instance data and the project components. In this manner, whenever an instance of a class is created in a project database, the schema of that created instance is also copied into the database. Thus, whenever instances of the class are extracted in future sessions, the schema is loaded into memory from the project database. The architecture is modular so that new data types can be easily added by modifying the field type object. Because the CDCDS is object-based, information can also be shared with other object-based programs by publishing appropriate interfaces. These facts are important since many programs across an organization refer to data captured and distributed during a real-world project. In addition, specifically arranging data in tables in the project database visually reveals relationships between items in the database that ordinarily seem unrelated. This visualization allows the users to instantly see the components of a project in their relationship to other components. A user can see information that helps them make decisions about the project management. These specific relationships between data in tables can be used by any database format.
A computer system and method for mobile Internet (portable) digital data capture and data distribution, where the computer system has a storage device, first and second platforms, a portable digital data capture and data/report distribution project, a means to forward a project subset during synchronous reconciliation between the first and second platform, and a first and second platform independent computerized data capture/distribution system (CDCDS). These systems and methods automate the definition, design, creation, manipulation, tracking, visualizing and distribution of a data capture and distribution project. Each platform is interfaced to the storage device and provides system-dependent services. The first platform has a first type of operating system and a first type of computer hardware including a first memory, and the second platform has a second type of operating system and a second type of hardware including a second memory. The digital data capture and distribution project resides in the storage device in a platform independent format and includes persistent component objects. The first CDCDS resides in the first platform memory and the second platform dependent CDCDS resides in the second platform memory. Each CDCDS provides CDCDS services that include: retrieving the digital data capture and data/report distribution project from the storage device; manipulating the project; changing the project by adding, redefining and removing persistent objects; marking the project for forwarding to the first platform; persistently saving the project to the storage device and reconciling versions; and marking the project for distribution on the Internet.
The present invention includes the following steps in a data capture and distribution project:
The above summary, as well as the following detailed description of a preferred embodiment of the invention, will be better understood when read in conjunction with the following drawings. For the purpose of illustrating the invention, there is shown in the drawings an embodiment that is presently preferred, and an example of how the invention is used in a real-world project. It should be understood that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings:
Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. In the drawings, the same reference letters are employed for designating the same elements throughout the several figures.
1. Overview of Present Invention
One of the novel concepts of the present invention is the use of objects which have the specific purpose of capturing data. Therefore, most of the objects used in the present invention may be referred to as "data capture objects" since they are used in one or more capacities to capture data. Table structures define the relationship between the data capture objects.
The present invention provides a data capture system having a project database which comprises a plurality of the data capture objects that are relevant to the project, and the table structures. The project database includes a plurality of project subsets. Each project subset is defined by a specific subset of the data capture objects which are required to perform the project subset.
In one embodiment of the present invention, the system includes a remote data capture input device (e.g., a handheld computer such as a Palm V organizer) and a central data capture management device. A subset of the plurality of data capture objects is downloaded from the central data capture management device into the remote data capture input device.
The central data capture management device uses shared libraries. However, neither the shared libraries nor their code are downloaded to the remote data capture input device. Thus, the project subset in the remote data capture input device implements the data capture process without a shared libraries or their code.
Shared libraries define the functions and some properties of objects. However, the data capture objects used in the present invention are defined by the project that they are located in. Thus, the use of shared libraries would not allow for the flexibility that data capture objects need to move from project to project. By avoiding the use of shared libraries with data capture objects, new projects can be created without having to change the code to define and reference more objects.
All of the properties of the data capture objects are not defined at the object's creation. Some of the properties of the data capture objects are not defined until they are placed into a project (i.e., marked for use in a project subset). The data capture objects have to be encapsulated with their respective relationships so that they can be moved into or shared with other projects without carrying the shared libraries or the entire database with them. Some necessary properties of the data capture objects include ownership, placement, transport between hardware, and a way to track them.
In sum, the present invention performs the following data capture process:
(1) A project database is created which includes a plurality of data capture objects that are relevant to the project. The properties of the data capture objects within the project database are partially defined.
(2) One or more project subsets are defined from a specific subset of the data capture objects. Additional properties of the data capture objects are defined as part of the project subset creation process. The additional properties may be different depending upon the project subset that the data capture objects are associated with. The additional properties define how the data capture objects are supposed to function in the project subset (e.g., which users of the input device are entitled to use the data capture objects, and which programs should receive the data capture objects). The additional properties provide the information which is normally obtained from shared libraries.
(3) The data capture objects of the project subset (s) are provided to a data capture input device, such as by being downloaded from the project database. No shared libraries or their code which exist in the project database need to be loaded into the input device.
(4) The input device executes the project subset using the downloaded data capture objects, and without needing any shared libraries or their code.
(5) After the appropriate data is collected, the input device is placed in communication with the project database and the data is forwarded to the project database for storage and analysis. One or more new project subsets may then be loaded into the input device.
2. Detailed Disclosure of Present Invention
Every transfer between a circle and a square in
The following is a detailed discussion of the steps involved in the conventional system 10 of data capture and data/report distribution. For the sub-process project design/development 12, there exist numerous steps beginning at the top of the box. A manager 22 performing form design logic 24FD chooses template software 26 and develops a template 28, which will be used for data entry by field workers 36 in the sub-process data collection 16. In project design and development 12, a courier 30 takes the template to a programmer 32 who loads the template software 26 and the template 28 onto a hardware 34 which is returned to the manager 22 and is then delivered by courier 30 to a field worker 36 seen in data collection 16. In the sub-process of project design/development 12, every time a manager 22 needs or wants to make a change to the template software 26 or template 28, the entire sub-process experiences a design/development redo loop 82. Tracking all changes to the template software 26 and templates 28, recalling them from field workers 36 in data collection 16 and verifying that changes have been implemented require an additional sub-process (not shown) that is time consuming, costly, and has tremendous potential for errors. For example, errors may occur if field workers 36 are not using the most recent templates 28 and template software 26. One suitable hardware 34 is a handheld computer such as a Palm V organizer, manufactured by Palm, Inc., Santa Clara, Calif. The embodiment of the present invention described herein uses the Palm V. Other Palm models, and other brands and types of handheld computers may also be used.
For the sub-process logistics 14, there are numerous steps to managing, tracking, and organizing logistics. Since data capture and data/report distribution are time sensitive and affect other departments, errors and slow-up due to multiple steps may mean that other departments in an organization experience work stoppage and errors as well. Coordination of efforts and tracking that updates and changes are made appropriately throughout the system requires a tremendous amount of time and effort on the part of the managerial staff, if it can be accomplished at all. In logistics 14, a manager 22 does a lookup for work due 46, performs logic 24 about which field workers 36 in data collection 16 should receive which assignments based on territory, skill level, etc. The manager 22 enters the assignments into a different template 28, which was developed in accordance with a different template software 26 from those used in project design and development 12. Then, a printer admin 38 pulls an assignment printout from the printer 40, which a courier 30 then delivers to a field worker 36 in data collection 16. In order to organize, track, and manage assignments, a manager 22 in the sub-process of logistics 14 is involved in a sub-sub-process of logistics reporting 14 a. The manager 22 must perform additional logic 24 about what logistics reports she needs to request from a programmer 32 who builds a logistics report interface 48 with which the programmer 32 can print a report. This report is brought to the manager 22 by a courier 30 and will reveal the status of assignments to the manager 22. With the conventional system 10, every time a programmer 32 is asked to change report parameters, a modification logistics report request 80 occurs. Every transfer and communication between parties creates an opportunity for errors and tremendous time lag, which causes further errors. For example, if the field worker's 36 templates 28 have not been input into the data entry interface 44 by data entry 42 staff in a timely fashion, then the manager 22 of logistics 14 will be unable to use a logistics reports interface 48 to verify that the assignment was completed. Thus a redo of assignment request 84 will occur with a different field worker 36 who then performs duplicate data collection. Duplicate assignments increase errors. In healthcare, data entry errors create an additional work loop for a redo of an assignment request 84. This increases assignment workload for field worker 36 by 20-30%, which is costly and time consuming.
In the sub-process data collection 16, a field worker 36 has received assignment information on what work is due and when it is due by courier 30 from a manager 22 of the sub-process logistics 14. The field worker 36 has also received templates 28 and template software 26 by courier 30 from a manager 22 of the sub-process project design/development 12. The field worker 36 must organize and track all of this information; perform data entry logic 24DE on what templates 28 and template software 26 should be used for each assignment; decide what questions should be completed during an assignment; decide what data entry should be made for each question; and decide how to save the template to a file. After the field worker 36 enters input into a template 28, a printer admin 38 gets a printout of the template 28 from a printer 40, which is given to a courier 30 for delivery to a manager 22. The manager 22 of the sub-process data collection 16 performs quality assurance logic 24QA by checking whether the template 28 is filled out completely, appropriately, and within the time frame allotted, whether errors are present, etc. If errors are present, which is the case in 20-30% of the work, a redo of data collection loop 72 is ordered to collect the correct data. These errors in information in the healthcare industry account for billions of dollars in hospitalizations, morbidity, lost wages, loss in employee productivity, and deaths. Templates 28 that meet a certain level of quality undergo data entry 42 into a data entry interface 44 that has been developed by a programmer 32. Every time that a change is made to the template 28 and template software 26 used by the field worker 36, the programmer 32 must rebuild a new data entry interface 44 to accommodate the change.
In the sub-process reporting 18, a manager 22 performs logic 24 to decide what needs to be reported on as a result of the data collection 16. For example, what items should be included in a report, what items in a report should be aggregated, to whom are reports distributed, how often are they requested, etc. The manager 22 relays these requests to a programmer 32 who then programs a report interface 50 to the main database 20. A delivery of reports loop 74 occurs each time the programmer 32 requests that a courier 30 deliver the report to the manager 22. Every time a change is needed on a report, a redo of a report request 76 occurs. With the current shortage of programmers 32, the constant requests for reports are often ignored. Programmers constantly perform logic (not shown) on triaging work in the order of importance. Reporting may not appear to be mission critical, yet the trend of increasing medical errors may belie that thinking.
In the preferred embodiment of the present invention, the CDCDS 70 seen in
The CDCDS 70 of
The CDCDS 70 of
Referring to
Referring to
Referring to
The process of creating or manipulating objects in a project requires a series of actions that precipitate visual feedback, confirmation and qualification of inputs. Therefore, the "state information" must be maintained while a user is making changes to the project. The project creator/report generator 108 controls the process of manipulating the portable digital data capture and data/report distribution project 58 by a set of queries (not shown). The project creator/report generator 108 has an expected set of inputs, which bring about predictable results. In a CDCDS 70 of the preferred embodiment of the present invention, it is important to implement one input over another. For example, changes are being made to protocols at the same time as other users are being forwarded the project subset 116 by the transport mechanism 104 of the framework 56 seen in
As seen in
As seen in
Section b has owner 300 (same as in section a) related to groups 394 which consists of ownerID 402, name 406 (a short text description that signifies the set of users that will be performing the specific type of data collection for an owner 300), groupID 420, and directoryID 410 in a not enforced, One-To-Many relationship.
Section c has surveys 220 (same as in section a) related to directory entries 396 which consists of directoryID 410 (an automatically assigned number) and surveyID 284 in an enforced, One-To-Many relationship.
Section d has surveys 220 (same as in section a) related to survey questions (known as field input forms 120) which consists of surveyID 284, FieldID 320 (a unique number assigned by the CDCDS user), Key 322 (set by the CDCDS user to designate status of the field), fieldname 356 (short text description of an individual field input form 120 that are referenced by other projects to aggregate normative information-unique for each field input form 120 that is part of a survey 220 but not unique across surveys 220), type 326 (signifies the nature of the field-input forms 120 referring to an example of a field types 114A supported), length 328 (denotes the number of character length for a text field-input form 120), format 330 (nature of field-input forms 120 that uses specific parameters) help 332 (denotes a section of the field-input form 120 that describes in some detail reference material shown on the screen for the field worker 36 to more easily make a decision on what input should be chosen), prompt 334 (a short text description of the input that is required in the field-input form 120), GUI 336 (denotes the design of the screen revealed to the user as field input form 120), Score 338 (signifies a weighted score value, signed byte), Score_value 340 (signifies the value needed for a Score 338), Score_method 342 (signifies under what circumstance an input is scored) Skip 344 (denotes the field-input form 120 to move to in a project schema 100), Skip_value 346 (signifies truth-value to skip), Skip_method 348 (signifies how the skip 344 is performed), Skip_relative 354 (what field input form 120 the skip method 348 will reveal as the next appropriate one), Reserved_one 380 (where in a report of the input collected with this field input form 120 should this appear), Reserved_two 376 (in what group in a report of the input collected with this field-input form 120 should be aggregated), PrintOnReport 378 (as it appears). These tables are in an enforced, One-To-Many relationship.
Section e of
Section f has directories 218 which consists of a directoryID 410 (as seen in section b) and a unique joinID 416 (an assigned number that signifies a connection between two items). This is related to group 394 (as seen in section b) in a not enforced, One-To-Many relationship.
Section g has directories 218 (as seen in section f) and directory entries 396, which consists of directoryID 410 and surveyID 284 in an enforced, One-To-Many relationship.
Section h has join entries 308 which consists of JoinID 416 (as seen in section f), survey1 ID 284 b (signifies the first survey 220 that will be connected to the second survey 220), field1 ID 320 b (signifies the connection point of the second survey 220), survey2ID 284 a (signifies the second survey 220 that is connected), field2ID 320 a (signifies the connection point of the second survey 220) related to directories 218 in an indeterminate relationship.
Section i has mobile users 390 which consists of a userID 412 (as seen in section e) hardware name 428 (signifies the nature of a hardware 34 that will be connecting through the framework 56 into the project database 60), last name 422 (the surname of the field worker 36 that will be using this hardware 34), first name 424 (the field worker 36 first name), initials 426 of the field worker 36) related to group membership 392 (as seen in section e) in an enforced, One-To-Many relationship. Each of the items in the tables in
The Programming Languate 124
In order to accomplish the integration of objects 114 into project schemas 100 shown in
a. The Shortage of Programmers
The availability of object oriented program sections have created the opportunity for programmers to incorporate these program portions in many different programs, making programming more efficient. However, a programmer must ensure that all required program portions are included appropriately in each program. To ease the burden on programmers, the preferred embodiment of the present invention includes a programming language 124 that requires created program portions to be stored with the databases that the program portions create. These stored program portions are formatted in a manner known to the kernel 92 of
b. The Ongoing Changes to Program Requirements by Users
Data capture and distribution projects often change based on the information needs of the enterprise. As information needs change, so do the requirements of the enterprise's programs. Some programs must remain "consistent" as changes are made to a project. Other programs must respond to the request for a change so that the new requirement is implemented appropriately to each program. Typically, when data is written to a file and read back, all of the strings and numeric data are read back appropriately but the complex relationships among the data may be lost. It takes a tremendous effort on the part of programmers to maintain these complex relationships. However, in the present embodiment, the logistics manager 110 of the framework 56 (see
c. The Need for Expanding Program Capabilities
As seen in
d. The Expanding Infrastructure Needs to Take Advantage of Internet and Wireless Hardware
Created program portions and data must be moveable from platform 94 to platform 94 without portability issues arising. The program portions and the data must operate in the same manner regardless of the particular configuration, operating system 96, software and hardware 34 of the platform 94. The CDCDS user must be able to copy the program portions for use on another platform 94. Preferably, the CDCDS 70 of the preferred embodiment of the present invention must be organized into shared libraries that implement methods and functionality so that the public interface to a class can be limited to the small scope of a shared library.
The programming language 124 coupled with the logistics component 126 (distribution of reports and information correctly) is of tremendous value in the health care industry and in other industries. It is of particular importance because the present invention allows a CDCDS user to make changes to any aspect of a project without having to program each element in a project or to program a new project each time an element changes. Also a programmer can add objects 114, etc. to the project database 60 without needing to reprogram all the current ongoing projects. This includes the ability to designate the changes to report requirements for a project at the same time. The following is an example of the value of this process in healthcare.
A portable digital data capture and data/report distribution project 58 will: 1) collect specific input from the heart monitor attached to the chest of an infant at 123 Main street on a continual basis; 2) distribute a subset of the input, e.g., heart rate 50 (dangerously low) and the location of the infant in a report to the fire rescue station that serves the 123 Main Street area; and 3) distribute the low heart rate, along with the infant's current medications, as a report to Doctor Jones who is the infant's cardiologist and forward a report to the hospital to which the infant is being transported. The result of this project is that before the mother of the infant wakes up enough to hear the alarm on the heart monitor sounding a low heart rate, the fire rescue is at the front door of the house with the doctor and hospital waiting for the infant's arrival. In the present invention, none of the complex communications between parties requires human interaction that has a potential for communication error and time lag. The entire project is developed and designed at the beginning by the CDCDS users with designations made on the type of data requested from in the field and the nature of and logistics of reports distributed. A CDCDS user with permissions can make a change to this project at any time even when the project is in session, and the fire rescue, doctor, and hospital, as well as the mother, immediately get the changes arid are now notified when the captured heart rate of the infant is below 70, not below 50.
Below are definitions of items that are seen in the code, followed by sample code with further explanation.
Field types 114A supported (seen in
date 212—DateTimeType This represents any date related field types 114A which are an important part of a project.
number 202—signed integer value (2bytes—SWord) includes yesno, yesnona, etc. It is important for ease of use by field workers 36 that these answer choices items appear as simple check boxes on the screen of a small device.
text 204—fixed length string (1 byte/char+1 byte null) includes any text entry and can be designated with a particular length. Although text entry is not optimal during a project, this field may be used for a signature capture, which can be thought of as a large text object.
vtext 206—variable length string (ID field linking to oVText). This results in a list of answer choices in a project that requires this. A CDCDS user designates the items on the list and designates the logistics requirements, e.g., is this list supplied through a query of other data sources or from data entered through the internet portal 186 of the framework 56.
New field types 114A can be easily added by modifying the field type 114A object, (e.g., truefalse, bar code, signature capture) and then making them available in the project database 60 for the CDCDS user to integrate into a project.
Field settings 114B shown in the entity relationship diagram seen in
Field settings 114B (seen in
Name Type
Field_name 356—a short text description of an individual field input form 120 that is referenced by other projects to aggregate normative information. Field name 356 is unique for each field input form 120 that is part of a survey 220 but not unique for a project schema 100. CDCDS users and field workers 36 can quickly identify items by the field_name 356, which appears in the field, input interface 112. Certain text are restricted from use as a field_name 356, e.g., date since the C++ code would reference that text as part of the code when it is not code.
FldID 320—number—or fieldID 320 are unique to each project schema 100 so that data integrity is maintained. However, fieldID 320 are not unique across the entire portable digital data capture and data/report distribution project(s) 58. A CDCDS user can organize input into categories using the fieldID 320 and then be able to aggregate and track data across projects. In healthcare and in many other industries, normative information is usually unavailable. Many different software requirements and many different types of paper forms have made it nearly impossible to standardize data capture without an act of congress. Using the fieldID 320 and/or the field_name 356 for tracking, allows a CDCDS user to implement numerous different projects yet have a way to aggregate data across projects. In addition, when a project is changed, as seen in
Key 322—yesno—This allows a CDCDS user to mark a field-input form 120 as key 322. Field-input form 120 marked as key 322 can then be given various functions in a project schema 100, e.g., aggregate reports by key 322 field-input form 120, copy set of key 322 field-input form between records 500, survey 220, joined project schema 100, etc.
Type 326—number—signifies the nature of the field-input form 120 referring to field types 114A supported. For example, for a type 326 designated with 0 the field-input form 120 is a yesno, yesnona, etc; for a 1 the field-input form 120 is a date; for a 2 the field-input form 120 is a float_number i.e. decimal points are accepted; for a 3 the field-input form 120 is a text that can accept text entries; and for a 4 the field-input form 120 is a vtext, i.e., a list of items. Additional types 326 can be added as needed and made available for the CDCDS user to integrate as part of a project.
Length 328—number—denotes the number of character length for a text field-input form 120. If number field-input form 120 and 1 signifies byte length, otherwise Word length.
Format 330—text—nature of field-input form 120 that uses specific parameters.
Help 332—vtext—denotes a section of the field-input form 120 that describes in some detail reference material shown on the screen for the field worker 36 to more easily make a decision on what input should be chosen for a particular field input form 120.
Prompt 334—vtext—a short text description of the input that is required in the field-input form 120.
GUI 336—number—denotes the nature of the screen revealed to the user as field input form 120. For example, for a GUI 336 0 the field input form 120 would reveal no GUI; for a GUI 336 1 the field input form 120 would reveal a yesnoform; for a GUI 336 2 the field input form 120 would reveal a yesnonaform, among others. Referring to GUI 336 supported: number is an integer value from −32,768 to +32,768; text is a fixed length text string; and yesno is a Boolean value true/false. GUI 336 can be easily added and then made available to the CDCDS user for integration in a project.
Score 338—number—signifies a weighted score value, signed byte. In projects that a Score 338 is measured based on input, this defines what point amount should be assigned. For example, input can be assigned a Score 338 of 1. To calculate the actual meaning of this number in a project, the following items score_value 340 and score_method 342 must be considered as well.
Score_value 340—number—signifies the value needed for a Score 338. This denotes what particular input will result in a weighted score. For example if the field-input form 120 has been designated with a score 338 of 1 and a score value 340 of 4 (denoting the input thorough), when the input 4 is made, a score 338 is recorded. If any other input is made e.g., 5 (denoting the input adequate), then a score 338 is not recorded. This gives the CDCDS user flexibility in signifying score 338 based on differing input.
Score_method 342—number—signifies under what circumstance an input is scored. For example, if a CDCDS user designates the score_method 342 0 then a noscore is performed; if the user designates the score_method 342 1 then an if_value_score is performed; and 2 is an if not_value_score. When integrating objects 114 into a project schema 100, the CDCDS user is allowed to designate values to these three field settings 114B, resulting in complex scoring capabilities. For example, if an input of 1 is made, this input can be read in conjunction with the above field settings 114B in order to designate a score for input. These three field settings 114B designated in combination together give the CDCDS user the ability to meet project-scoring requirements. Additional field settings 114B may be easily added as required.
Skip 344-number—denotes the field-input form 120 to move to in a project schema 100. This field setting 114B and the following two field settings 114B give the CDCDS user the ability to program project protocols 516 into a project schema 100.
Skip_value 346—number—signifies truth-value to skip. This signifies what value of input would require a skip 344. This can be done for numeric values. However, if text were assigned a numeric value, a skip 344 can be assigned to text as well.
Skip_method 348—number—signifies how the skip 344 is performed. For example, if a CDCDS user designates the skip method 348 0 then noskip is performed; if 1 then if value_skip is performed; if 2 then if not_value_skip is performed; if 3 then a special_skip is performed; if 4 then if_value_skip_over is performed; if 5 then if_not_value_skip_over is performed; if 6 if_not_value_skip_to_end; among others.
Skip relative 354—text—what field input form 120 the skip method 348 will reveal as the next appropriate one.
Reserved_one 380—numeric—where in a report form 118 of the input collected with this field input form 120 should this appear.
Reserved_two 376—numeric—in what group section in a report form 118 of the input collected with this field input form 120 should be aggregated.
Additional skip settings can be added as needed and made available in the project database 60 for CDCDS users to designate values to input that will allow a complex set of protocol 516 (see
GUI types—related to GUI 336:
Number—integer value from −32,768 to +32,768
Text—fixed length text string
yesno—boolean value true/false. Additional GUI 336 can be added by modifying the GUI 336 and making any additions available in the project database 60. The following are methods/functions 114C that are available for programming a field-input interface 112 of
Methods and Functions 114C:
The fact that the present invention has solved the naming convention is also extremely important for the integrity of the reports that are immediately accessible when data is returned to the project database 60. The naming of fields using key 322, the ability of the present invention to copy fields marked as key 322 between records 518 as designated by the CDCDS user, and the creation of input tables 310 by the present invention, ensures that data made available in reports is valid and that correct report parameters set by the CDCDS user at the beginning of the project are followed through the entire project. As can be seen in
An example of Record 518 find methods available in the program are:
An example of Record 518 access methods available in the program are:
Additional methods/functions 114C can be easily added by a programmer and made available for use in the project schema 100. The present invention allows a great degree of flexibility in making additions and adding functionality.
The following is an example of the classes/objects 114 available for use.
Classes/objects 114 as seen in
Class: oFormDB 208
Type: Derived class from oaTable 210
Description: All databases with which the user interacts are instances of this class.
Fields are variable based on CDCDS user designation. This is how the field-input forms 120 will accept input from field workers 36. This can be expanded to accept inputs automatically without the interaction of human user, e.g., as when a device measuring and inputting data 52 is made part of a project.
Class: oFixed 214
Type: Derived class from oaTable 210
Description: All databases, which are unchangeable, are of this type. An unchangeable table in the present invention is a designated choice table 312 that appears in the field input form 120 as a list of choices. The list will be designated by the CDCDS user to appear in a particular field-input form 120 as a function of the joins 216, which is shown in
Class: oJoins 216
Type: Derived class from oaTable 210
Description: Table of all the connections between tables, which must be separate from other tables 400 in the project database 60 since they occur between tables. A join 216 is how the CDCDS user designates where a choice table 312 from the fixed 214 mentioned above would appear in a particular field input form that is part of a particular field input interface 112. A field worker 36 accessing a field-input form 120 cannot alter a field-input form 120 of a formDB 208 with ajoin 216 to a fixed 214. This is one of the ways that integrity of the data is kept throughout the system from the point of access by a CDCDS user for the purpose of logistics management to the point of a field worker 36 choosing an input from a choice table 312. An example of how the joins 216 is illustrated in
The explanation above of
The following is a list of fields that allow the CDCDS user to designate a particular set of survey 220 characteristics 520 that denote the functionality of the survey 220 in a directory 218 for a particular project. A survey 220 is part of the directory 218 which consists of directory entries 374 of one or more survey 220 and their field input forms 120 as shown in
Internal Structures:
Below are descriptive details for some of the methods/functions 114C in the preferred embodiment of the present invention to illustrate how the programming language 124 is used to designate the methods/functions 114C of a portable digital data capture and data/report distribution project 58. Sample code for some are included for illustrative purposes.
oaTable::oaTable 210
Constructor method for oaTable 210 to load an existing table or create one if needed as discussed for
Deconstructor method for oaTable to close a table.
Returns number of fields, which correspond to individual field-input forms 120 that are part of the field-input interface 112 of a project subset 116.
Retrieves information that was input by a field worker 36 into a field input form 120. It is just the input that is retrieved not the forms or any other part or requirement of the greater project. The retrieval of only the marked data is important because of the size of the object 114. Since this system is designed for remote use, it is important to consider the time it would take for a data object to travel. As this is applied to wireless technology, the less time the actual transfer of data takes place, the less chance of error and wear on the equipment, e.g., batteries. When the information that was input arrives at the project database 60, it is then correlated to the correct tables in relation to the project subset 116 of the portable digital data capture and data/report distribution project 58.
Retrieves and stores the number of field input forms 120, which correspond to the number of fields in a project schema 100, in specified tables.
Retrieves and stores the number of input in the field input forms 120 of the survey 220. This function combined with the previous function of the program is essential because they allow the field input forms 120 of the survey 220 and data to be stored, moved, and joined separately.
Calculates the size of a record 518. A record 518 as listed here is defined as a collection of field input forms 120 that are part of a particular survey 220 that are generated by the program for the purpose of receiving input from field workers 36 as part of a particular schema 100 in a project. Questions as listed below are field-input forms 120.
Calculates what next field-input form 120 should be revealed to the field worker 36 based on the CDCDS user designating a particular skip 344, skip_value 346, and skip_method 348 that is referenced in the project database 60. Based on protocols 516 designated by a CDCDS user during the creation of a portable digital data capture and data/report distribution project 58, the code supports revealing certain field input forms 120 if a field worker 36 chooses an item on a choice list with a join 216 to the survey 220 of this field input form 120. For example, if a field worker 36 selects input from the choice table 312 for the doctor's last and first name, then the field input form 120 "enter last name of doctor" and the field input form 120 "enter first name of doctor" will not be revealed to the field worker 36. However, if the doctor's name is not one of the choices in the choice table 312, then the field worker 36 can select *Not on List 1* which is set by the program to add to each choice table 312. It is important to allow the field worker 36 this level of flexibility. The code in the section below illustrates how the present invention calculates what is the next field input form 120 to be revealed to the field worker 36 based on the input made and the protocol 516 programmed into each field input form 120.
Skip functions need to be efficient, since, as will be shown in the real world project section in
UInt oaTable::NewDerivedRecord(oaTable *source,UInt recID, Byte fldnum)
This part of the code of the present invention allows field input forms 120 designated by the CDCDS user as key 322 to be copied and used in a completely different field input form 120 for a different survey 220 marked with the characteristic of following this survey 220. A key 322 is unique to an individual field input form 120 but not across surveys 220. Each key 322 is independent within the survey 220 and can be inserted into any applicable survey 220 that is designated with this survey characteristic 520. This function in combination with the questiontocopy 368, allows the CDCDS user to mark only certain field input forms 120 for copying to a new record 518. The present invention allows the user to mark non key 322 in among the key 322, yet only the key 322 are copied bringing the field worker 36 to the next appropriate field input form 120 in the next record 518. In addition, it is not necessary to mark all that are key 322 to be copied. The example shown in the real world project will illustrate how this allows considerable flexibility when programming a project schema 100. The field-input forms 120 can then be aggregated in relation to any field-input form 120 where the CDCDS user marks the key 322. Allowing unique fields in this way lets a CDCDS user track changes to projects or compare project input with other project input.
This section of code specifies the relationship between two tables and the objects 114 stored in them. The relationship can be chosen to relate one object 114 to many or many objects 114 to one. This is illustrated in
Loads up the previous question (field input form 120) and voids the answer to this question (field input form 120) 50 it must be completed to move on to the next question (field input form 120).
This function retrieves the database and displays how many surveys 220, how many records 518, and how much memory is available for this particular project schema 100. Records in this case are an instance of a set of field input form 120 that have been generated by the program as a result of selecting the command 522 "new". This allows the field worker 36 to see the progress of the overall project.
If the user wanted to check on the status of a particular input, this function would be used to display the status of the records 518 for that survey 220. It communicates which field input forms 120 are answered and which field input forms 120 remain to be answered. It will also tell the field worker 36 when the input was begun in the field input forms 120.
Boolean DefaultQuestionHandleEvent(EventPtr eventP);
This part of the code is responsible for picking the next question (field input form 120) to load. If there is no skip function programmed by the CDCDS user for this field input form 120, it automatically goes to this handler and the handler passes it around until it finds the next question (field input form 120).
This initializes the Jump forms. Uses a pointer to reference the choices of answers. The jump will be based on the answer. This allows the field worker 36 to move to a specific field input form 120 without moving through each of the field input form 120 prior.
Boolean JumpDialogFormHandleEvent(EventPtr eventP);
Boolean JumpDialogFormHandleEvent(EventPtr eventP)
This is the way the jump is executed. A pointer is assigned and the jump is linked with the question field input form 120 and the pointer passes the information of the input (answer) and the jump is made based on this input.
This sets up a table for the field input form 120 that is designated to be a memo field type 114A where input is to be stored. A pointer is assigned so the table information can be changed and the current information can be accessed through the pointer.
This function is the pointer accessing the current information that resides in the memo field input form 120 table. As this is applied to the memo format, the same programming logic is applied to the other types of field input forms 120 with field types 114A such as date, number, text, yes/no, yes/no/na, or any other specified answer group.
This initiates the select form function. It is similar to the field input form 120 process but in this instance the function is actually selecting an instance of a survey 220 which contains field input forms 120.
This event is preformed through a pointer function. This ensures the latest directory 218 gets to the field worker 36.
After the instance of a survey 220 is selected this sets up the physical field input form 120 of the survey 220 by displaying the appropriate place to enter input.
This initializes the field input form 120 so that it can be put into use.
This event is responsible for getting the most recent version of the instance of a survey 220 with correct field input forms 120 in order for the field worker 36 to enter input.
The above section references the part of the code that is responsible for loading a particular instance of a survey 220 for a field worker.
This part gives the user a custom directory 218 based on the preferences that are specified by the owner 300 of the project subset 116.
DWord PilotMain( Word cmd, Ptr, Word)
This part of the code allows the project subset 116 to be forwarded to the specific hardware of the field worker 36 and be functional.
Deconstructor method for oaTable 210 to close a table.
Returns number of fields that correspond to individual field input forms 120 that are part of the field-input interface 112 of a project subset 116.
Calculates the size of a record 518. A record as listed here is defined as a collection of field input forms 120 that are an instance of a survey 220 that may or may not include input made by a field worker 36. Questions are the field-input forms 120 in a record 518.
Sets the field of a record 518 for text fields type 114A field input forms 120, word field type 114A field input forms 120, byte field type 114A field input forms 120, date field type 114A field input forms 120, etc.
This ends the section on the programming language 124 of the present invention.
In order to explain an important functionality of the present invention, refer to
During connection to the project database 60 changes between the project subset 116 and the field input interface 112 is reconciled as requested by the CDCDS user. The field-input interface 112 is designed to reveal one field-input form 120 per screen with a limited but adequate number of input choices on that same screen. When the field worker 36 makes the input into the field-input form 120 the data is temporarily stored and a new field-input form 120 appears on the screen. If necessary, the logic is already programmed into the field input interface 112 so there is no chance of omitting a response or inputting a frivolous response. Once the fieldwork is complete, the data is ready to be returned to the project database 60 through whatever transport mechanism 104 needed. Again, there is no need for the field worker 36 to make special commands during the transport, since all necessary work is performed by the present invention for the field worker 36. It is important to realize that only the input is being transmitted to the project database 60 because the field-input interface 112 is still stored in the hardware 34.
After the input is transferred back to the input table 310 of project database 60, the returned input is aggregated in the manner specified by the owner 300 when programming the project schema 100 with the programming language 124 (seen in 8A) into the database. At this time, there are no decisions that must be made by the owner 300. This information is ready to be accessed at any time by the owner 300. The owner 300 can enter the database at any time to retrieve the reports. It is also possible to present the reports on the Internet portal 186 or directly to the owner 300 via electronic mail or paging.
The preferred embodiment of the present invention has incorporated automating the design and building of dynamic intelligent forms that are designed to deliver data that is needed for analysis rather than attempting to extract useable information from available data. The report component of the process is included in the process from the beginning, making additional programming of reports unnecessary, but more importantly, making the reports available immediately upon receipt of the data from the field.
A key component of the preferred embodiment of the present invention has been to include the application of logistics to data capture and report distribution and the utilization of data structures to economically facilitate efficient logistics with the visualization of indirect relationships in the project. This next section will discuss the visualization of indirect relationships and explain how it is incorporated into the overall portable digital data capture and data/report distribution project.
The Visualization of Assignment Logistics Management
The logistics for data capture are very important. The integrity of any project is heavily based in the logistics as is seen in
The assignment information management needs of today's enterprise are constantly changing and workers return less and less to the enterprise where there is access to a myriad of programmers and support staff all keeping track (or trying to keep track) of current workflow and changes and additions to workflow. Therefore, the preferred embodiment of the present invention includes assignment logistics for a project as an integral part of the invention. Assignment logistics are tracked, organized, managed, and reported on just as it is necessary to track package delivery. Assignment logistics is complex for any industry and is extremely complex as part of a portable digital data capture and data/report distribution project 58 in the example of clinical trial investigators. For example, investigators (field workers 36) may have several sites where they see patients in a clinical trial. These same physicians may be part of several group practices, which manage the business of one or more of these sites in combination. However, all the physicians in a group practice, may not see clinical trial patients, or just not see clinical trial patients at each of the group sites but only at a few of the group sites. To complicate matters, a physician may contract with several different pharmaceutical companies for clinical trials and therefore need to meet the requirements of several different pharmaceutical companies clinical trails with which they contract. In addition, the patients that are part of a clinical trial may see different physicians or may be seen at different sites that are part of a clinical trial. The present invention can offer efficiency during a clinical trial as long as there is consistency in the reporting of data on the clinical trial.
The present invention allows the CDCDS user to organize one or more projects (clinical trials) for one or several owners 300 (pharmaceutical companies). Numerous field workers 36 may be partaking in the clinical trial project. The present invention has the flexibility and scalability to allow the CDCDS user to set up a portable digital data capture and data/report distribution project 58 that involves the investigators as field workers 36 and the logistics management for clinical trials with patients. However, the following diagrams, both for this section, and for the real world project section, is an illustration of providers 512 (physicians) in
Afterward, the project creator 108 will prompt the CDCDS user that the project is ready to accept input in the logistics manager 110 where additional details can be added or changed in the project database 60 with regard to the workflow of assignments as part of a portable digital data capture and data/report distribution project 58 in the project database 60. Assignment workflow data is connected directly to the project by supplying data to the choice tables 312 for a particular project subset 116 (as seen in
The CDCDS user will also establish what set of providers 512, sites 542, groups 536, and surveyors 516 are related to the owner 300 of this project. The logistics manager 110, as a result of the data structures shown in the entity relationship diagrams in
To manage the assignment logistics for a project, the logistics manager 110 must reference the tables seen in
The assignmentID 502 in
In order for the present invention to accomplish the complex process of assignment logistics management and visualization, the CDCDS user must access the logistics manager 110 of the framework 56 as seen in
The assignment logistics for a project is organized by the present invention to consider all the sites 542 as a whole in direct conjunction with the field workers 36 who will be capturing data, and the distribution of reports. For example, the site 542 is the key factor in an assignment. In many industries where logistics information management is involved, an enterprise has contracts with remote sites. For example, a supplies distributor has a group of contracted locations where the supplies are delivered. It may be that during the life of a project, the responsible party at the site may change, or the type of supplies delivered may change. However, the site 542 itself is generally stable. This is even more the case with the healthcare industry where clinics, hospitals and medical offices usually remain at a particular address, but doctors, patients, equipment, is constantly changing. With the sites 542 all made available in the project database 60, the project owner 300 can attach or detach a site 542 to a provider 512, as seen in
The groups and the hospitals can be manipulated in the same fashion as seen in
The example listed here relates to healthcare because of the very complex nature of providers in relationship to different group practices and different sites. The examples above are all based on audits that health insurance companies perform on the providers and groups. However, this technology may be applied to other fields, such as sales. An example of this would be a company similar to Avon cosmetics that would be the owner 300. The majority of sales are not in stores, but rather selling from people's homes. The owner 300 Avon, using the present invention, could give out their field workers 36 a simple hand held hardware 34 that could be forwarded a project subset 116 (see
Reports forwarded to this owner 300 can show where there are too many sales people, which areas in the territories are not being covered, and even what product people are buying. The order forms can be programmed as project schema 100, thus automated with logic programmed into the field-input forms 120 to bring up points of sale. For example, if an Avon customer purchased a fragrance, as soon as that fragrance order was entered into the field input form 120, the preset logic would remind the sales person to ask if the customer wanted a matching body lotion. The idea of a specific set of field input forms 120 and logic going to a specific field worker 36 who is a salesman can be very helpful to sales as well. Since this sales person is in this territory, going to this site, and speaking with this customer, the information of past sales will already be in her field-input interface 112 as it was forwarded by the present invention. When the customer orders a fragrance, the sales person can offer the same color eye shadow that the customer had purchased six months ago. The orders that are put into the field input interface 112 can be used to distribute the product, and can also be used to track sales and trends. The corporate office can have the orders aggregated to keep track of sales purchases and patterns, sales people, customers, and products without further data collection.
A key feature of the logistics manager is the ability to allow the CDCDS user to visualize on the screen, any indirect relationships between the items in the tables in the project database. In the previous discussion, the screen shots in
The logistics manager accomplishes these things partially based on the logic in a set of queries that allow the CDCDS user to view the indirect relationships between items in the data tables in
Additional queries are written (not shown) that will make reporting on workflow simple. The complete relationship of the assignments that can be visualized by the CDCDS user in logistics manager 110 can be seen in
The result of these queries shows unobvious relationships.
Real-World Project Sample Items Using the Conventional System
The following is detailed information on the conventional system 10 for a real world data capture and distribution project for medical providers' performance/compliance measurement and reporting for ACME HMO, illustrated in
The following example provides detailed information on how the preferred embodiment of the present invention is used in a real-world data capture and data distribution project. This example is an illustration of the preferred embodiment of the present invention in use for an actual healthcare company. All identifying information has been removed from the documents for reasons of confidentiality. This example was chosen because it illustrates the ability of the CDCDS 70 of the present invention to automate project design, project and assignment logistics, data capture and data/report distribution for a somewhat complex healthcare provider compliance measurement project. During this project life, there were additional requirements for changes. The present invention performed its functions without disruption to the data capture tasks of the workers and without disruption to the data already available in the project.
In the preferred embodiment of the present invention, a CDCDS user must first collect the requirements and specifications for a project. This information is usually available by reviewing all of the documents shown in
Next, a CDCDS user organizes the information about the project before using the CDCDS to create the project. This is done in order to organize the requirements and specifications of a project as one would before using a programming language to build an application that accepts input, processes information and produces output that is needed for best results in the project. The CDCDS user then builds a flow diagram that will help the CDCDS user to more efficiently build the project schema 100 using the programming language 124 of the present invention to integrate project objects 114 and all other elements into a portable digital data capture and data/report distribution project 58, as seen in
The assignment 500 logistics aspect of the ACME HMO example are screen shots of the logistics manager 110 in
For this project, the CDCDS user programmed the general medical record review audit 158 in
The flow diagram in
The next flow diagram seen in
Organizing the field input form 120 in this fashion would eliminate the need for the field worker 36 to read the question 162 pertaining to the GYN doctor when it is an OB doctor. This saves the field worker 36 time and also reduces to possibility of a field worker 36 making input erroneously. As can be seen in the rest of
In other words, the field input forms 120 are grouped as they relate to a set of parameters for a group of field input form 120 representing a grouping of questions 162 in the audit forms 158 for the project. Just as writing code allows a program to perform functions, reference other code, and reference algorithms for managing logic, the flow diagram of
The present invention allows the CDCDS user a tremendous amount of flexibility in building the project schema 100 for the portable digital data capture and data/report distribution project 58. An audit of the project 58 showed that the present invention reduced the number of questions by 63% because the logic associated with field input forms 120 reduced the number of questions presented to the field worker 36. In addition, the automatic input made by the program (when appropriate) and the restrictions on the type of input allowed, reduces error and increases the readability factor that is important in reducing error. In addition, the automatic input made by the program when appropriate and the restrictions in the type of input that can be made, reduces error, as well as the readability factor that is important in reducing error.
The next set of figures are screen shots of the project creator/report generator 108 of the framework 56 through which a CDCDS user of the preferred embodiment of the present invention can access the project database to program a portable digital data capture and data/report distribution project 58. The project creator/report generator 108 is equipped to guide the CDCDS user through the use of the programming language 124 of the present invention to build the project schema 100 for the project. It is through this project creator/report generator 108 that a CDCDS user begins by designating the project owner 300 for the portable digital data capture and data/report distribution project 58, which for this example is ACME HMO. The toggle box 700 on
For example, referring to
Project schemas 100 are similar to objects created with other object oriented programming languages such as JAVA and C++. Using the programming language 124 of the preferred embodiment of the present invention, a CDCDS user creates "objects" that can be reused in other projects. Making previously programmed project schemas 100 available for incorporation into other projects and/or other owners 300 applies object oriented design (that is, making small program portions available for reuse by other programs) to the CDCDS 70. Programming tools can be built that allow a user to keep project schemas 100 organized in a library of code as is done in C++ programming, and to make these project schemas available more easily for other projects. In addition to building programming tools for the programming language 124 of the preferred embodiment of the present invention, programming tools can be built for adding objects 114 to the project database 60. A programming tool such as this can more quickly allow the expansion of the capabilities of the CDCDS 70. The owner, however, interacts with the database through the project creator/report generator 108 and therefore does not need to have knowledge of the programming language 124. The project creator/report generator 108 acts as a translator between the programming language 124 and the user. This tool enables people who do not know the programming language 124 to efficiently and accurately build their own project schema 100. The project creator/report generator 108 does not allow the user to make inappropriate relationships, or affect the current data residing in the database that does not apply to this particular project schema 100. This tool also allows the user to set up the necessary data tables 310 and choice tables 312 and relationships between the tables 310 and 312. An example of this schema 100 and the relationships between the entities is illustrated in
The CDCDS user now has access to any or all of the object schema stores 62 of the project database 60 shown in
These syncs 288 ensure that every field worker 36 who has group membership 392 in group 394 which also contains owner ID 402 which refers to the owner 300 ACME HMO gets these particular surveys 220 which the user is setting up in the project creator/report generator 108. With these syncing functions, the owner sets up the individual directories 218 for individual field workers 36. The screen shot in
Designing the field input forms 120 for a project schema 100 is, in effect, the process of designing a project subset 116. As illustrated in
The screen shot in
Input tables 310 also store the pre-designated numeric values for field input forms 120 that have been skipped programmatically e.g., if the field input form 120 was not revealed to the field worker 36 based on the protocol 516 for the prior question (see
Project schema 2 100 consists of a survey 220 site environment 4 followed by a survey 220 required exit interview and the accompanying field input forms 120, fixed forms 121 and the associated input tables 310 and choice table 312. Although it is not always the case, both of these project schema 100 reference the same choice tables 312 as the other project schema 100. A list of choices come from the choice tables 312 which is of fixed form 121. This fixed form 121 is not a field input form 120 that will appear to the field worker 36 in the field input interface 112, and it is not able to be edited by the field worker 36. Instead, as seen in
In the present invention, project schemas 100 may or may not have choice tables 312. Choice tables 312 will only be created by the CDCDS 70 if joins 216 are programmed to be part of the project schema 100. A choice table 312 is an organized grouping of selected data chosen by the owner 300 to be presented to the field worker 36 as a list of possible input that can be made for specific field-input forms 120. Choice tables 312 have been designated as fixed 214 tables, which means that a field worker 36 will not have the ability to change this data. These choice table 312 have been marked by the CDCDS user to "sync to palm by user" so that during a connection with the project database 60, the choice table 312 data will be forwarded to the appropriate individual field worker 36. The nature of the three project schema will also affect the look of the field input interface 112. Since there are three project schema 100 on the ACME HMO field input interface, the main screen will have three different choices for the field worker 36. The choice table 312 can be linked to external databases in an enterprise, or populated by the forms of the logistics manager 110 or of the internet portal 186 of the framework 56 seen in
As shown in
Another important feature of the present invention that can be seen is that the CDCDS user is allowed to mark a field input form as key 322 and to recognize the field input forms 120 marked key 322 or as not being marked. Field input forms 120 may or may not be marked as key 322. This characteristic key 322 is important for copying and skipping field input forms 120 and aggregating the data from them.
In addition, when the program is copying the input in fieldID 320 marked key 322 among two different surveys 220, the program disregards the numerical identification of the fieldID 320 and simply copies the first 9 key 322 as requested by the CDCDS user in the original design and development of the project. Referring again to
Consider an example wherein ACME HMO wants the first nine field input forms 120 which are marked key 322 of chart audit 6 to be copied into site environment 4. The field input forms 120 were marked with the characteristic of key 322 in the project creator/report generator 108. In
The field worker 36 has all the information needed to complete this particular field input form 120. Another feature illustrated in
These questions in the dialog boxes relate to the logic of the project schema 100 flow as seen in
Again, the hardware 34 initiates the transport protocol. The input returns to the database and the programming language builds and fills the appropriate input tables 310. The information now resides in the first platform 94. Only the input data is returned to the database because the survey 220 remains in the first platform hardware 542. This particular method also makes the files as small as possible for efficiency and integrity. As soon as the first platform 94 receives the information from the second platform hardware 34, the reports are already available as a programmed report that is put together and displayed for the owner 300.
Built-in message automation of the project creator/report generator 108 gives the present invention the ability to guide and restrict the CDCDS users to build the project in accordance with the object 114 limitations or restrictions and in accordance with the requirements of a project, e.g., a text object needs a length parameter.
The CDCDS user has already prepared the reports for the ACME HMO, already formatted designated parameters and marked the pertinent data to be aggregated. The reports are generated once the data is received from the hardware 34. The owner 300 must now return to the project creator/report generator 108 and query the project subset 116 that pertains to this owner 300 in order to gain access to the reports from the project database 60.
An example of a report for the ACME HMO project can be seen in
As discussed above, the project creator/report generator 108 allows the user to mark the appropriate data to be reported on. The programming language then creates the input tables 310 to be filled with the information from the field-input forms 120. This is an important function of the CDCDS that allows for the creation of real time reports to be available. There is a tremendous amount of information available for an organization with these reports. As can be seen in these figures, the report is formatted to produce an aggregate result for all the data regarding this project database 60. Numerous other slices of the data are immediately available as reports. This example for ACME HMO was a somewhat complicated request for reports.
Another important feature in the present invention is that based on the data structures and the relationships between and among data types, the CDCDS user can also make reports available on data aggregating the information between projects. The healthcare industry, as well as other industries, are at a great disadvantage when comparisons cannot be made because disparate systems are used. The present invention can be used as the infrastructure or operating system for mobile workers or devices in an organization for dynamically capturing data with the dynamic report component being produced at the same time. The logistics aspect of report distribution has not been discussed in great detail. However, the very same elements used in the present invention can be applied to the logistics of report distribution as well.
The present invention may be implemented with any combination of hardware and software. If implemented as a computer-implemented apparatus, the present invention is implemented using means for performing all of the steps and functions described above. The present invention can also be included in an article of manufacture (e.g., one or more computer program products) having, for instance, computer useable media. The media has embodied therein, for instance, computer readable program code means for providing and facilitating the mechanisms of the present invention. The article of manufacture can be included as part of a computer system or sold separately.
It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention.
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