Computer system for portable digital data capture and data distribution

Abstract

A computerized data capture system is provided that has a project database. The project database includes a plurality of data capture objects that are relevant to the project and table structures which define the relationship between the data capture objects. A scheme is also provided for capturing data. A project database is created including a plurality of data capture objects that are relevant to the project. One or more project subsets are defined from a specific subset of the data capture objects. One or more project subsets are then provided to one or more data capture input device.

Claims

What is claimed is:

1. A computerized data capture system having a project database, the project database comprising:

(a) a plurality of data capture objects that are relevant to the project; and

(b) table structures which define the relationship between the data capture objects, wherein the data capture objects are a type of object used in an object-oriented programming environment.

2. The system according to claim 1 wherein the project database includes a plurality of project subsets, and the system further includes (i) a remote data capture input device, and (ii) a central data capture management device, wherein a subset of the plurality of data capture objects necessary to perform a project subset are defined and downloaded from the central data capture management device into the remote data capture input device.

3. The system according to claim 2 wherein the table structure is maintained in the central data capture management device and is not loaded into the remote data capture input device.

4. The system according to claim 2 wherein the input device is a handheld computer.

5. A method of capturing data comprising:

(a) creating a project database including a plurality of data capture objects that are relevant to the project;

(b) defining one or more project subsets from a specific subset of the data capture objects; and

(c) providing the one or more project subsets to one or more data capture input devices, wherein the data capture objects are a type of object used in an object-oriented programming environment.

6. The method of claim 5 wherein step (a) further comprises partially defining properties of the data capture objects, and step (b) further comprises defining additional properties of the data capture objects after the data capture objects are placed in a project subset so that project subsets may be provided to, and executed in, the one or more data capture input devices without using any shared libraries or their code, wherein the additional properties define how the data capture objects are supposed to function in the project subset.

7. The method of claim 6 wherein the additional properties of the data capture objects define which users of the one or more input devices are entitled to use the data capture objects and which programs should receive the data capture objects.

8. An apparatus for capturing data comprising:

(a) means for creating a project database including a plurality of data capture objects that are relevant to the project;

(b) means for defining one or more project subsets from a specific subset of the data capture objects; and

(c) means for providing the one or more project subsets to one or more data capture input devices, wherein the data capture objects are a type of object used in an object-oriented programming environment.

9. The apparatus of claim 8 wherein the means for creating a project database further comprises means for partially defining properties of the data capture objects, and the means for defining one or more project subsets further comprises means for defining additional properties of the data capture objects after the data capture objects are placed in a project subset so that project subsets may be provided to, and executed in, the one or more data capture input devices without using any shared libraries or their code, wherein the additional properties define how the data capture objects are supposed to function in the project subset.

10. The apparatus of claim 9 wherein the additional properties of the data capture objects define which users of the one or more input devices are entitled to use the data capture objects and which programs should receive the data capture objects.

11. An article of manufacture for capturing data, the article of manufacture comprising a computer-readable medium holding computer-executable instructions for performing a method comprising:

(a) creating a project database including a plurality of data capture objects that are relevant to the project;

(b) defining one or more project subsets from a specific subset of the data capture objects; and

(c) providing the one or more project subsets to one or more data capture input devices, wherein the data capture objects are a type of object used in an object-oriented programming environment.

12. The article of manufacture of claim 11 wherein the computer-executable instructions of step (a) perform a method further comprising partially defining properties of the data capture objects, and the computer-executable instructions of step (b) perform a method further comprising defining additional properties of the data capture objects after the data capture objects are placed in a project subset so that project subsets may be provided to, and executed in, the one or more data capture input devices without using any shared libraries or their code, wherein the additional properties define how the data capture objects are supposed to function in the project subset.

13. The article of manufacture according to claim 12 wherein the additional properties of the data capture objects define which users of the one or more input devices are entitled to use the data capture objects and which programs should receive the data capture objects.

14. The method of claim 5 further comprising:

(d) assigning executable properties to objects in the subsets.

15. The article of manufacture of claim 11 wherein the computer-executable instructions further perform a method comprising:

(d) assigning executable properties to objects in the subsets.

Description

COPYRIGHT NOTICE AND AUTHORIZATION

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.

BACKGROUND OF THE INVENTION

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.

CDCDS Requirements

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.

BRIEF SUMMARY OF THE INVENTION

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:

1. Write object-oriented code that defines data types, function, methods, and logistics of a data capture and data distribution project.

2. Integrate the objects into a group of objects, which represents a real-world project and define the function of and logistics of objects in the group.

3. Query a subset of these objects from the project database for the purpose of forwarding the subset to users or devices, which will perform transactions or view reports on this subset.

4. Perform transactions using this subset of objects.

5. Query the project database for the purpose of forwarding and synchronizing any changes made to the subset by any user or device.

6. Visualize and manage the logistics of the project.

7. Write new objects code and make the objects available for integration into any current or new project.

8. Write new visual interfaces and add to the project framework to automate additional functions.

BRIEF DESCRIPTION OF THE DRAWINGS

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:

FIG. 1A is a diagram of the conventional (prior art) process workflow for a data capture and data distribution process;

FIG. 1B is a legend that illustrates the items in FIG. 1A for easy reference;

FIG. 2 is a diagram representing the process workflow using the preferred embodiment of the present invention;

FIG. 3 is a diagram of the overall architecture of a CDCDS in accordance with a preferred embodiment of the present invention;

FIG. 4 is a more detailed block diagram showing elements included and or accessed by the framework and kernel of FIG. 3;

FIG. 5 is a diagram showing elements that are included and/or accessed by the project creator of the framework;

FIG. 6 is a diagram showing how objects are part of a project schema and how project schemas are part of the CDCDS project;

FIGS. 7A and 7B illustrate the tables and the relationships between the objects that reside in the database of the preferred embodiment of the present invention;

FIG. 8A is a view of the project database and the relationship between the objects with in the database and relationship of the project creator to the database;

FIG. 8B is a diagram of the logistics component showing the relationship between a directory and its components and a field worker and its components;

FIG. 8C is a block diagram that illustrates the input and storage of data;

FIG. 8D illustrates the use and storage of choice tables;

FIG. 8E illustrates changes made to a survey and the results.

FIG. 9 is a relationship diagram illustrating the preferred embodiment of the present invention;

FIG. 10 is an illustration of the encapsulation of a field worker and how project schema can share that field worker;

FIG. 11 is an illustration of the encapsulation of a project schema and how many field workers can share that schema;

FIG. 12 is an illustration of the encapsulation of a project and how the schema and field workers can share parts of projects;

FIG. 13 is a screen shot from the project creator/report generator;

FIG. 14 is a block diagram showing the movement of information between the project database and the field input interface and its consequent relationships;

FIG. 15 is a block diagram illustrating a cycle of information flow from the project subset to the hardware and back to the project subset;

FIG. 16 illustrates a report query in relation to a project subset;

FIGS. 17A-17H illustrate the relationships between the objects that are present in the preferred embodiment of the present invention;

FIGS. 18A-R deal with the logistics component of the CDCDS wherein FIGS. 18A-18L are screen shots of the logistics manager, FIGS. 18M-18P are screen shots of queries in the logistics manager, and FIGS. 18Q-18R are diagrams of the relationships visualized through the logistics manager;

FIGS. 19-28 are paper forms used in the conventional system for data capture and distribution;

FIGS. 29A and 29B are examples of a time-line outlining the steps for the preferred embodiment of the present invention;

FIGS. 30A-30C are diagrammatic views of project schema 1-3 showing how the entities of each schema relate to one another;

FIG. 30D is a flow diagram for an entire project schema;

FIG. 30E is a flow showing the interchanges between the different components of field input forms;

FIG. 30F is a detailed flow diagram illustrating the intelligence and sequence of field input forms;

FIGS. 31A-31E are various screen shots of the project creator/report generator;

FIGS. 32A-32E are screen shots of the project creator/report generator pertaining to field input forms;

FIGS. 33A-33O is a printed report of the field input forms as they appear on a survey;

FIGS. 34A-34C are diagrams illustrating the elements and relationships of project schema 1-3 respectively;

FIG. 34D is a detailed description of the project schema and how they relate to the portable digital data capture and data/report distribution;

FIG. 35 is a printed report of the field input forms for a chart audit 6 with the fields marked as key;

FIG. 36 is a printed report of the field input forms for a site environment 4 with fields marked as key;

FIGS. 37A-37G are screen shots of the second platform hardware of various field input forms;

FIGS. 38A-38K is a printed report based on the real world project; and

FIGS. 38L-38N are the screen shots from the project creator/report generator.

DETAILED DESCRIPTION OF THE INVENTION

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.

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.

Detailed Disclosure of Present Invention

FIG. 1A is a diagrammatic representation of the workflow and responsibilities for a conventional (prior art) system 10 data capture and data distribution. As can be seen in the drawing, the conventional system 10 includes several main components or sub-processes: project design/development 12, logistics 14, data collection 16, and project reporting 18, each which interfaces with an enterprise's main database 20. FIG. 1B is a listing of the items for ease of reference to FIG. 1A. FIG. 1A is a graphic representation of the involvement of non-technical staff (circles); technical staff (triangles); computer equipment, e.g., hardware, software, data template files (squares); logic (curved rectangles); and interfaces. Circles represent non-technical staff of varying skill levels that include managers 22, couriers 30, field workers 36, printer admin 38, and data entry 42. Triangles represent programmers 32 of varying skill levels. Squares represent template software 26, templates 28, mobile hardware 34, and printers 40. Curved rectangles represent logic 24, quality assurance logic 24QA, data entry logic 24DE, and form design logic 24FD that is performed by staff, for example, requesting an assignment based on skill level or territory, choosing what forms to complete for an assignment, or choosing answer types. Rectangles represent data entry interface 44 to the main database 20, logistics reports interface 48 to the main database 20, and report interface 50 to the main database 20, as well as lookup for work due 46.

Every transfer between a circle and a square in FIG. 1A takes time and money and introduces the potential for communication errors. Capturing and distributing data and reports is a vital part of the ever-changing enterprise. Therefore, changes to every aspect of data capture and data/report distribution are made frequently. Any changes must be tracked and organized so that old designs and old report parameters are removed from circulation before implementation of the new ones. The new design and new report parameters need to be distributed to appropriate parties. All staff involved in the conventional system 10 must be trained and retrained with each change. Data capture and data/report distribution occurs nearly everywhere in the health care industry and in other industries where the organization depends on getting information from workers and sharing that information across the enterprise. As mobile hardware and telecommunications services are more widely used, the enterprise needs to take full advantage of the hardware and services available for data capture and data/report distribution. The errors, redundancy, and lack of efficiency that is self evident in the conventional system 10 depicted in FIG. 1A are costly. In healthcare, 30 cents of every dollar of the 1.4 trillion dollars spent on healthcare in the United States are attributable to administrative activities. The preferred embodiment of the present invention can significantly reduce administrative costs and medical errors.

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 14a. 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.

FIG. 2 is a diagrammatic representation of the workflow and responsibilities for the CDCDS 70 of the preferred embodiment of the present invention. A CDCDS 70, shown in FIG. 2, allows field workers 36 or a device capable of measuring and inputting data 52, managers 22, a main database 20, other enterprises 64, healthcare providers 66, consumers 68, and others 86 to share and access a portable digital data capture and data/report distribution project 58 through a customizable interaction 54 that is part of the framework 56 of the CDCDS 70. The framework 56 performs project design logic, passes messages between project components and/or individuals, manages project interactions, reconciles project versions, forwards project changes, tracks and organizes project logistics, etc. In essence, the framework 56 automates certain tasks in order to free users to perform higher level tasks, remove redundancies and errors from the system, reduce time and costs, and produce better quality information. The CDCDS 70 of FIG. 2 does not require many of the tasks and requisite staff in the conventional system 10 of data capture and data/report distribution of FIG. 1A. Specifically, the CDCDS 70, does not need programmers 32 to build, modify and upgrade a data entry interface 44, logistics report interface 48, and report interface 50 to the main database 20. There is no need for attendant couriers 30, printer admin 38, data entry 42, template software 26, templates 28, logic 24, or lookup for work due 46. In addition, modification reports request 80, delivery of reports loop 74, redo of report request 76, redo of data collection 72, design/development redo loop 82, and redo of an assignment request 84 are eliminated. All of these are required by conventional system 10 of data capture and data/report distribution. These staff and tasks are not present in FIG. 2 because of the resulting automation accomplished by the preferred embodiment of the present invention. The functions that are automated and the subsequent staff and tasks that are eliminated will be described below as they impact programmers 32, managers 22, and field workers 36.

In the preferred embodiment of the present invention, the CDCDS 70 seen in FIG. 2 eliminates the ongoing need for skilled programmers 32 to develop, update, modify and track version control of the data entry interface 44, logistics report interface 48, and report interface 50 of FIG. 1A. As shown in FIG. 2, a CDCDS 70 user that has minimal technical training can access the framework 56 to access the object schema store 62 in the project database 60. This process eliminates some managers 22 who perform logic 24 about managerial functions, modification report request 80, redo of project report request 76, and delivery of reports loop 74, that routinely recur related to programmers 32, along with attendant couriers 30 and data entry 42 as seen in FIG. 1A.

The CDCDS 70 of FIG. 2 eliminates the need for numerous managers 22 that perform logic 24 in the sub-process of logistics 14, quality assurance logic 24QA in the sub-process of data collection 16, and form design logic 24FD in the sub-process of design/development 12 of the conventional system 10 of FIG. 1A. Managerial functions, such as the design/development redo loop 82 and redo of an assignment request 84 of FIG. 1A, are eliminated, along with the attendant couriers 30, printer admin 38 and field workers 36. As shown in FIG. 2, the framework 56 of a CDCDS 70 is set to perform these tasks automatically and eliminate the trivial and repetitive work (see FIG. 1A) of logic 24, quality assurance logic 24QA and form design logic 24FD. This automation occurs as a result of the CDCDS 70 user integrating specific items in object schema store 62 already available in the project database 60 to be forwarded as part of a project subset 116 to field workers 36 and others. In a CDCDS 70, for example, managers 22, are able to design a project, request all report parameters at the time of project design, view various reports on input from field workers 36, connect with a main database 20 to verify data against input from the field, etc. The CDCDS 70 gives users the scalability to ramp up or ramp down a project as well as add new projects without the geometric increase in work.

The CDCDS 70 of FIG. 2 eliminates the need for numerous field workers 36. Since a CDCDS user has designated a portable digital data capture and data/report distribution project 58, field workers are forwarded what is appropriate to each individual field worker 36. Thus, input is made in the portable digital data capture and data/report distribution project 58 directly by field workers 36 responsible for the work, eliminating double data entry and the errors associated with data entry. The framework 56 allows approved input only, restricts entry, reveals items for input based on the input in prior fields, pre-loads data, and prompts the user if incorrect input has been chosen. In the preferred embodiment of the present invention, the CDCDS 70 performs the data entry logic 24DE of FIG. 1A conducted by field workers 36, thus eliminating redo of data collection loop 72 that routinely recurs related to errors found during quality assurance logic 24QA, as well as attendant couriers 30, managers 22, printer admin 38, template 28 and data entry 42 in FIG. 1A.

Referring to FIG. 3 the preferred embodiment of the present invention includes a CDCDS 70 having an architecture of layers that include a portable digital data capture and data/report distribution project 58 consisting of object schema store 62 of a project database 60, a dynamic framework 56, and a kernel 92 connected to the underlying platform 94. These layers are each made with different tools and are meant to perform different functions. It is the architecture that allows the portability and the flexibility to expand, add functionality, and add increasing automation to the CDCDS 70. The kernel 92 provides the services necessary to load/execute the higher levels and to provide an interface to the system-dependent services of the underlying platform 94 which consists of the operating system 96 and the hardware 34. The hardware 34 has memory, such as RAM, in which the kernel 92, the framework 56 and a portion of the portable digital data capture and data/report distribution project 58 reside at run-time. There is at least one storage device, such as a hard drive, in which the portable digital data capture and data/report distribution project 58 is stored. For this preferred embodiment of the invention, the kernel 92 is written in C++ which is a well-known programming language that is compiled using vendor tools that are appropriate to that platform 94, and is thus platform specific for each of several platforms. The kernel 92 may be written on other programming languages, if desired. Using a function call-based programmer interface ("API"), the kernel 92 performs services for the higher levels. The API's native code functions are accessed via direct calls from the framework 56. The kernel 92 is not portable but can be extended by loading additional modules with associated DSL files.

Referring to FIG. 4, the kernel 92 consists of the support libraries 98 that are necessary for the CDCDS programs. These include libraries for file and resource I/O, configuration management, memory management and diagnostics, etc. These support libraries can be changed when the platform of choice for the project is changed. The kernel 92 manages part of the transport of objects when connections are made to the field. The framework 56 provides the visual interfaces between the CDCDS and the CDCDS users. The framework 56 consists of the internet portal 186, project creator/report generator 108, report forms 118, logistics manager 110, system messages 122, and the project subset that includes the transport mechanism 104, field input interface 112, and field input forms 120, along with other subsystems. The framework 56 provides access and incorporates the necessary CDCDS logic to the project and to the project subset 116 forwarded to the hardware 34. The project subset 116 is designated as a specific field input interface 112 referenced to the project schema 100 of the portable digital data capture and data/report distribution project 58. This project subset 116 is named by the CDCDS user to be forwarded by the transport mechanism 104 to a specific hardware 34. The framework 56 is written in C, C++, Visual Basic, and HTML (the framework need not be limited to these languages) for maintainability and extensibility, although Java and XML could be implemented at any time. The framework 56 is not necessarily portable and may perform differently on different platforms 94.

Referring to FIG. 5, the project subset 116 is where the framework 56 queries to access the current state of the project. The project subset 116 references the project schema as seen in FIG. 4. The project subset 116 is created as part of the initialization of the framework 56. Report forms 118 and field-input forms 120 are employed as the interface between the user and the CDCDS 70. Field-input forms 120 and report forms 118 are implemented using the services of the API of the kernel 92 and are notified when an event occurs either as a result of input or as a result of other program events. Report forms 118 receive input from CDCDS users during the initial design or when changes are made to a CDCDS portable digital data capture and data/report distribution project 58 and changes are available immediately throughout the project. Logic has been programmed into the project creator/report generator 108 to remove the burden of logic from human users. The project creator/report generator 108 returns various system messages 122 to the user such as a reminder that a particular object is unable to be integrated into a project without including the object's functions.

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 FIG. 4. However, these different inputs will likely conflict with one another. It is necessary to mark which input will overwrite other input and under what circumstances this should occur. In order to accomplish this, the CDCDS 70 allows users with specific permissions to mark and integrate the functions of objects that are part of the field input forms 120 to respond in a particular ordered fashion in the portable digital data capture and data/report distribution project 58. It is because of this process that the CDCDS 70 of the present embodiment allows the user access through the project creator/report generator 108. The project creator/report generator 108 exhibits a system message 122 to the CDCDS user that input has been accepted, or why it has not been accepted and then reveals the result of the input. If the CDCDS user is not satisfied with the result of the input, then the CDCDS user is able to make additional input to change the results.

As seen in FIG. 4, the portable digital data capture and data/report distribution project 58 consists of one or more project schemas 100, or any other domain specific schemas. FIG. 6 shows that in the preferred embodiment of the present invention, a project schema 100 consists of a set of project objects 114 that are relevant to a particular project or to a particular discipline existing in an object schema store 62. Multiple objects 114 integrated into multiple project schemas 100 as part of the object schema store 62 can be combined to form a portable digital data capture and data/report distribution project 58 as seen in FIG. 4. FIG. 6 shows these multiple project schemas 100 made of multiple project objects 114 located in an object schema store 62 where it is necessary to have the project objects 114 and the project schemas 100 available together for the purposes of consistency. Additional objects 114 can be built by programmers and made available in an object schema store 62 for the CDCDS user to integrate into new project schema 100 or existing project schema 100. This allows for easy expansion of the capabilities of the CDCDS and the portable digital data capture and data/report distribution project 58 (of FIG. 4) without requiring a programmer to retool all of the already in use project schemas 100.

FIGS. 7A-7B is an entity relationship diagram showing all the tables 400 with their structures and the attributes of each of the tables 400 that are part of the object schema store 62 in FIG. 6. The tables 400 in FIGS. 7A-7B show all that is available for integrating into project schema 100 of FIG. 6. The relationships of the tables 400 and their items shown in FIGS. 7A-7B is a configuration of the present invention so that when a CDCDS user opens the project creator/report generator 108 in the framework 56, the user can simply choose items shown in the project creator/report generator 108 to be part of a specific project schema 100 and the present invention will automatically manage the relationships of the items in the project schema 100. This management of relationships between items is a component of what is referred to as the logistics. Logistics in the present invention is the management of getting the correct information to the correct people on time, without overlap or omissions (i.e., the organization of who gets what and when). For example, the CDCDS user names the owner 300 and the objects 114, field types 114A, field settings 114B, and methods/functions 114C that are designated for this owner 300 in each of the appropriate tables.

As seen in FIG. 7A section a, owner 300 consists of a unique ownerID 402 (an automatically assigned number) and a name 404 (a short text description that signifies the CDCDS user or group 394 of users). Section a also includes the related survey 220 which consists of the SurveyID 284, OwnerID 402 a name 324 (a short text description that describes the set of field input forms 120), type 286 (either a FormDB 208 or a fixed 214), title 362 (a short text as it appears on the field input interface 112 on the hardware), howtosync 288 (signifies the way the data from this survey 220 is transported between the field and the server), nextsurvey 290 (signifies and identifies the survey 220 that is to follow this one), questionstocopy 294 (signifies all the field input form 120 marked key 322 whose input should be copied to the next instance of this survey 220), reservedone 370 (signifies the score group of the report that this survey 220 is part of), reserved two 372 (signifies the report group this survey 220 is part of for aggregation) in a not enforced, One-To-Many relationship.

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 FIG. 7B has group 394 (as seen in section b) related to group membership 392 which consists of groupID 420 (as seen in section b) and a unique userID 412 (an assigned number that signifies a particular hardware) in a not enforced, One-To-Many relationship.

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), survey1ID 284b (signifies the first survey 220 that will be connected to the second survey 220), field1ID 320b (signifies the connection point of the second survey 220), survey2ID 284a (signifies the second survey 220 that is connected), field2ID 320a (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 FIGS. 7A and 7B are referenced in the project database 60 by the programming language 124 of FIG. 8A.

FIG. 8A illustrates the CDCDS user entering the project database 60 through the project creator/report generator 108 of the framework 56 to first designate necessary aspects of the logistics component 126. As seen in FIG. 8A, the logistics component consists of the designation for the owner 300 and field worker 36 related to particular project schema 100 that are part of the project. In the present invention, FIG. 8A shows a CDCDS user integrating objects 114 in the project database 60, by using the programming language 124 of the present invention. This allows the user to design, develop, and manipulate project schema 100, and then relate the owner 300 and field worker 36 to each project schema 100 in FIG. 8A. Relating the field worker 36 and the owner 300 is part of the logistics component 126 of the portable digital data capture and data/report distribution project 58.

FIG. 8B illustrates the logistics component 126 in more detail. In FIG. 8B, a field worker 36 is partially represented as a mobile user 390 which is a combination of a userID 412, specific hardware 34, staff member last name 422, first name 424, and initials 426 (as in FIG. 7B section i). The present invention is arranged this way so that hardware 34 can be easily replaced if loss or breakage occur without interruption in the job of the field worker 36. The field worker 36 would continue to connect to the project database 60 without interruption. A field worker 36 is also represented with a group membership 392, which is a combination of the userID 412 and groupID 420. A staff member having a particular group membership 392 allows a CDCDS user to connect the staff member to a group 394 which consists of a directoryID 410 (directory 218 of project schema 100) for one or more owners 300. This allows the field worker 36 to be connected to the project schema 100 in several portable digital data capture and data/report distribution projects 58, as shown in the block diagram FIG. 10. A field worker 36 may also be connected to directories 218 of project schema 100 that are related to several different owners 300 as seen in the Venn diagram of FIG. 9. For example, as seen in FIG. 10, a nurse (field worker 36) can perform work related to several different project schema 100, e.g., the schema for auditing charts and the schema for auditing medical facilities. As seen in FIG. 9, a nurse (field worker 36) can also work on several different projects (belong to a group 394 which is related to a directory 218 used by two owners 300) in the same organization or in different organizations. It is necessary for the CDCDS user to designate a field worker 36 with these three sets of characteristics and then relate them to owners 300 who are then related to the survey 220 that are part of a project schema 100 as seen in FIG. 8B because of the need to organize and manage the logistics of assigning skilled workers to particular tasks. The present invention prompts the CDCDS user to designate and relate each item that is necessary to the logistics component 126 of a project as seen in FIG. 8A. The present invention allows the CDCDS user to change the logistics component 126 of a project at any time during the life of a project without interrupting any aspect of the project.

The Programming Language 124

In order to accomplish the integration of objects 114 into project schemas 100 shown in FIG. 6, the preferred embodiment of the present invention includes an object-oriented programming language 124 shown in FIG. 8A. This programming language 124 references the tables shown in FIGS. 7A and 7B that are part of the project database 60 of FIG. 8A. A CDCDS user defines certain characteristics of the project, and based on these designations, the logistics of a project is managed. The present invention manages the logistics of report distribution since the program creates data tables in the project database 60 to store input from field workers 36, which will be distributed as designated by the CDCDS user in the initial design and development of the project. The present invention also manages the logistics of updated information sent to field workers 36 since the program creates data tables in the project database 60 to store input sent to field workers 36, which will be distributed as designated by the CDCDS user in the initial design and development of the project. These data tables created by the program will be discussed at length in the next section. The use of the programming language 124 of the present invention seen in FIG. 8A solves a number of problems: a) the shortage of programmers, b) the constant changing of program requirements by users, c) the need for expanding program capabilities, and d) the expanding infrastructure that needs to take advantage of Internet and wireless hardware. A detailed explanation of how the preferred embodiment of the present invention solves each of these problems is outlined below.

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 FIG. 3 and are thus executable on all platforms 94 for which a kernel 92 has been supplied. This makes the software needed to manipulate data always available so that a programmer is not needed each time a project is invoked or if a current project is changed.

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 FIG. 5), provides a mechanism to maintain complex relationships across user sessions, making program portions usable together even though the portions were developed independently. Program portions and data need to be encapsulated as much as possible and provide functionality to other program portions. This means that as much as possible, information is to be hidden and accessed programmatically, and not by direct reference. This allows independent program portion evolution and error isolation.

c. The Need for Expanding Program Capabilities

As seen in FIG. 8A, the CDCDS user enters the project database 60 through the project creator/report generator 108 to integrate current objects 114 and their field types 114A, field settings 114B, and methods/functions 114C. (Hereafter, 114, 114A, 114B and 114C are referred to as "current objects 114, etc.) A programmer can write additional C++ code, expanding the choices for the CDCDS user to reference in the project database 60 and integrate into a project schema 100. Any existing portions or projects must be able to employ the new project objects 114, etc. without making additional programming changes. It is also important to be able to create a new type of project object 114, etc that is a specialized version of an existing project object 114, etc. It can be assumed that any method that operates on the existing object 114 can also operate on the new type of object 114, yet the new type of object 114 has some additional characteristics. In addition, as the projects increase in size, the project database 60 where the objects 114, etc are stored needs to be able to accommodate the increase in the size of the project. All program portions must refer to standard database industry procedures in order to accommodate the changes in the program capabilities.

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.

FIG. 8A is a block diagram showing the key language features of the preferred embodiment of the present invention that support object-oriented programming and allow a user to access the project database 60 and add, remove, integrate and declare objects 114 into schemas. The CDCDS user can also designate the field types 114A, field settings 114B, and their methods/functions 114C and how these items should be represented in a report. Using the programming language 124 includes making designations of reporting requirements as part of the project schema 100. The preferred embodiment of the present invention allows a CDCDS user to configure the entire portable digital data capture and data/report distribution project 58 starting with the design of the data elements to be captured through to what completed reports on the data collected are being distributed and where. This includes the logistics component 126 of the project, i.e., what elements in a project are being forwarded to owners 300 and field workers 36, to what hardware 34 are they being forwarded, and how do owners 300 and field workers 36 relate to a directory 218 as seen in FIG. 8B.

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 and are now notified when the captured heart rate of the infant is below 70, not below 50.

FIG. 8A is a block diagram that shows the programming language 124 which defines and describes the actions of all the objects 114, etc that are integrated into a portable digital data capture and data/report distribution project 58. A CDCDS user is given access to the project database 60 through the project creator/report generator 108. The portable digital data capture and data/report distribution project 58 is programmed by the CDCDS user to consist of one or more project schemas 100 as part of a directory 218 that is related to owners 300 and field workers 36. The key features of the programming language 124 include but are not limited to: classes/objects 114, field types 114A, field settings 114B, GUI 336, and methods/functions 114C i.e., record find methods, record access methods, and miscellaneous record functions. Architecture is modular and new items can be easily added by modifying the existing or programming additional objects 114, etc. All data is actually stored in a FormDB 208 and fixed 214. Objects 114 include but are not limited to: oaTable 210-abstract base class for all table data; oDirectory 218-directory of all tables-builds maintains, and destroys all objects; oFormDB 208-contains all user entered data; oFixed 214-used for building and referencing lists of items in data tables; oJoins 216-objects list of all joins 216; and oAnswer 274-returned data or choices made in the oFormDB 208. The code should avoid using many (if any) defines and the calling code module would want only the directory 218 to be declared as a global. Included below is more detailed information about the objects 114, field types 114A, field settings 114B, methods/functions 114C that make up the programming language 124 of the present invention. Some examples of the actual code are included that illustrate the items being discussed. Actual code documentation is included as well. Interspersed are some comments that are an additional explanation on a section of the code, but are not part of the code. It is important to note that most of the explanations and illustrations make reference to the field input interface 112 of the framework 56 in FIG. 4 that is accessed by the field workers 36. However, the programming language 124 of FIG. 8A allows the CDCDS user to define reports and designate the logistics management of report distribution. A CDCDS user is allowed to mark input for aggregation in input tables 310, mark input by key 322 field input forms 120 for aggregating scores, and deliver an aggregate report to an appropriate owner 300. Whereas the conventional system 10 requires the programming of reports separately every time a new project is established, the present invention does not require that a CDCDS user build a different report each time new request for input is made or field input forms 120 marked key 322 are changed, etc. The CDCDS user has been allowed to create a report that will be distributed as a project subset 116 to an owner 300 (see FIG. 16) just as a field input interface 112 is created by the CDCDS and marked for delivery as a particular project subset 116 to a field worker 36 (see FIG. 14). The report is built and distributed as it was designated by the CDCDS user at the time of creation of the project.

Below are definitions of items that are seen in the code, followed by sample code with further explanation.

Field types 114A supported (seen in FIG. 8A):

date 212--DateTimeType This represents any date related field types 114A which are an important part of a project.

number 202--signed integer value (2 bytes-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 FIG. 7A section d, which depicts how each of the field settings 114B are used and how they relate to other items in the project. FIGS. 31A-31C is a similar entity relationship diagram that shows how all of the items relate to each other as part of the project schema 100 for the example project for ACME HMO.

Field settings 114B (seen in FIG. 7A section d):

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 FIG. 35, the CDCDS 70 can track the changes made to a field input forms 120 individually, or as they exist as part of a project schema 100 (see FIGS. 31A-31C.

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 FIGS. 30E and 30F) to be part of the field input interface 112. FIG. 14 shows the field input interface 112 as part of the directory 218 so that the individual field worker 36 will receive it as part of the project subset 116 on the hardware 34 that is designated for them only. The field-input interface 112 of FIG. 14 is set specifically for the exact piece of hardware 34 connecting to the project database 60. The CDCDS user accesses the programming language 124 through the project creator/report generator 108 to build the project schema 100 and mark them with a specific field worker 36 of a specific owner 300 as seen in the logistics component 126 of the portable digital data capture and data/report distribution project 58. The above three skip field settings 114B integrated in combination for each field input form 120 allow the CDCDS user to program protocol 516 and criteria logic that will allow the field input interface 112 to reveal only field input forms 120 according to programmed criteria, an example of which is seen in FIG. 30E and FIG. 30F. For example, a protocol 516 can be programmed by the CDCDS user that commands the field input interface 112 to not reveal to the field worker 36 field input form 120 #4-7 (Is prostate exam done?, Is testicular exam done?, Do male patients over 40 yrs receive rectal exams?) if a field worker 36 inputs "yes" in field input form #3 (Is this patient female). The logic programmed in each field input interface 112 and in each field input form 120 depends on how the CDCDS user organizes the above skip field settings 114B at the design and development of the project or during manipulation of the project. The present invention must allow the CDCDS user to have the ability to organize each of the three field settings 114B that relate to moving over or past field input forms 120 for criteria that require decisions to be made by the field worker 36. For example, a protocol 516 can be programmed to reveal the field input forms 120 relating to questions about an adolescent even if the field input form 120 for birth date is input with an adult birth date. Perhaps a field worker 36 has received an assignment to review care that was performed on adolescents who are now young adults. These complex protocol 516 are maintained each time that a field worker 36 connects to the project database 60 to be forwarded the project subset 116 that was designated specifically for them shown in FIG. 14. As seen in FIG. 8A, any project schema 100 changed by a CDCDS user will have the changes forwarded to the field worker 36. As long as the survey 220 is part of the directory 218 that is related to a field worker 36, as seen in FIG. 8B, changes in a survey 220 are immediately made available to the field worker 36 without any loss of integrity of the project.

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 FIG. 14.

Methods and Functions 114C:

FIG. 8C is a diagrammatic illustration of how the programming language 124 of FIG. 8A handles particular methods/functions 114C. All of the necessary objects 114, field types 114A, field settings 114B, and methods/functions 114C have been designated and described by the CDCDS user in the project database 60, using the programming language of FIG. 8A. In FIG. 8C, the compiler 498 references the project database 60 and loads the necessary program portions so that, as seen in FIG. 8C, an instance of a survey 220 with a very particular set of survey characteristics 520 (FIG. 14 will illustrate a diagram of how particular survey characteristics 520 are part of a project subset 116 forwarded to a hardware 34) is generated by the program. The survey 220 consists of a set of field-input form 120 that is generated on the hardware 34 by the program portions. When the field worker 36 initiates a method/function 114C by selecting a command 522 (e.g., new), an instance of a set of field input forms 120 constituting a record 518 is generated by the program. The record 518 is named according to the fieldID 320 or set of fieldID 320 that have been designated as key 322 by the CDCDS user in the project database 60. This allows the CDCDS user to set the naming conventions for a record 518, thus eliminating naming issues for each record 518 on the part of each field worker 36. By doing this, the present invention eliminates the file naming version control of the conventional system 10. These record 518 also appear on the hardware 34 of the field worker 36 as an instance of a record 518 with the file name designated by the input that the field worker 36 has made into the fields input forms 120 marked key 322. The records 518 are placed in the order in which they were generated by the field worker 36, since on a small screen, all field input form 120 marked key 322 are not visible to the field worker 36. Allowing more of the key 322 to be revealed on the screen of the field worker 36 can solve this problem.

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 FIG. 8C, the input table 310 contains both record 1518 and record 2518 of input from the instance of the field-input forms 120 generated with the command 522 "new" by the field worker 36. This ensures that there is no additional programming needed to query by fields marked as key 322. A record 518 is set with the correct name automatically, and the report is simply referencing the correct records 518. This also guarantees the accurate management of the logistics of report distribution since the same fields marked as key 322 are referenced for report distribution. FIG. 8C illustrates that a record 518 of input 524 in each of the field input form 120 is transported back where a table is created in the project database 60. This input table 310 is created by the program to store an instance of the record 518 with only the field_name 356, the userID 412 and the registered input from this field worker 36. This record 518 is immediately available in the project database 60 to an owner 300 who accesses the report forms 118 of the project creator/report generator 108 of the framework 56 seen in FIG. 4 without additional querying of the project database.

An example of Record 518 find methods available in the program are:

Word FindFirst Record (Byte fldID, CharPtr s);

Word FindFirst Record (Byte fldID, Word n);

Word FindNext Record (Byte fldID, CharPtr s);

Word FindNext Record (Byte fldID, Word n);

An example of Record 518 access methods available in the program are:

    virtual Uint          RecordNew ( ); //two entry points for records
    virtual void          RecordOpen (Uint recID)
    virtual CharPtr       SetRecord (Byte fldID, CharPtr s); //returns
                          null if fails
    virtual Word          SetRecord (Byte fldID, Word n); //returns null
                          if fails
    virtual Byte