Teleform is an Optical Character Recognition (OCR) program used to collect large amounts of data, both accurately and quickly. The program was developed as a natural progression to the old ScanTron technology. Data are collected (recorded onto a form) and the form is scanned or faxed into the system. After review by DMC staff, data is transferred into the study’s database.
New forms are designed within a form designer according to the needs of the protocol. Data points can include bubbles, numeric values, free text, signatures, and bar codes. While legibility will always be a factor, with properly completed bubbles, verification is limited to the hand-printed responses, eliminating the need to review/key enter much of a form. The data are validated using a custom written script, which checks for valid range, skip patterns/entry required, and cross-field or cross-form consistency.
Database management is an important aspect of research studies that requires a clear understanding of the problems under investigation as well as the formal data processing that will be needed by the study. Success at achieving this combination is rare. To address this deficit, the ISAP Data Management Center (DMC) was designed to allow principal investigators (PIs) to focus entirely on the management of protocols and the design of the survey instruments, while the DMC handles programming to facilitate the data entry process and ensure that the data are valid. In addition, the DMC provides the PI with ongoing tracking of the study’s progress, which is perhaps the DMC’s most valuable role.
Web-based Data Entry
Advances in Web-based computer technologies offer new promise for researchers, including enhanced approaches to data collection and multidisciplinary data management. In comparison to more traditional approaches to research data management, Web-based technologies allow simultaneous data entry and extraction by all investigators regardless of geographic location. In addition, changes in data capture can be made in a timely fashion in order to maximize the quality of data being collected. Site requirements are minimal for basic data entry—just reliable Internet access and a Web browser. Client-side prompts and validation checks assist in the data entry process, including both within-form and cross-form checks.
While ISAP’s Data Management Center cannot fully alleviate the first two disadvantages, it can alleviate much of the third. The DMC offers a vast library of forms (811 as of April 2007) which can be converted into static Web-based entry forms. New forms can be added to the library by using Cardiff’s Teleforms as the form generator. Scrolling can be minimized by programming the form so that the client “jumps” from one question to the next appropriate question (skip pattern). While implementing changes to Web-based forms can be labor intensive, once programmed, such changes are fully adopted across all new interviews. Traditional paper forms typically require time to disseminate the updated instrument(s) to all staff.
To compare all data capture systems managed by the DMC, please see this Web page: http://www.uclaisap.org/dmc/html/capture-system.html
Features of Web-Based Data Collection
Key field data, such as header information, can be pre-populated, and custom error messages can be programmed to appear either when a given question receives a response or when the entire form is submitted. These error messages can be formatted either as warnings (which allow the record to be submitted) or as stops (preventing the record from being submitted). Forms can be printed directly from the Internet browser, providing a back-up copy of the responses.
Studies often choose to create a lead-in Web page, which controls access to the various forms expected to be completed during a given study visit. As forms are completed, they can be “locked,” preventing duplicate entry. Once data are submitted, a unique serial number is generated and provided to the user. This serial number allows the supervisor to view and modify the data as needed. Additionally, considering that some surveys are completed during two or more sessions, this serial number allows data to be added to a partially completed interview (with supervisor-level access).
Security of the Web forms is of primary concern. Users cannot assign to themselves the rights of data entry, but rather the project investigator must specify which users can enter data and which can modify existing data. This permission is revocable at any time.
Lastly, reports are created according to the needs of the study. These Web-based reports reflect the up-to-the-minute status of the study’s data. Such reports often summarize a patient’s progress through the study and show detailed information on the number of screened participants and the number of follow-up interviews completed. Additionally, the reports can provide global views of participant demographics, participant intake characteristics, or treatment provided. Reports provide the PI with a method to monitor certain critical measures, which can be invaluable in assuring that the data collection is proceeding as expected and that it will fulfill the study goals.
Data collection across the Internet provides a secure and reliable method to process study data and allows for remote data input from as many sites as needed in as many locations as needed. Resulting data are housed in the DMC’s SQL server and will be given back to the PI (or designate) in any required format, according to their schedule demands.
While no perfect data collection system exists, data entry across the Internet is a fast, reliable, and secure method to capture data. It also reduces paperwork (with associated costs) required by more traditional forms of data entry and is perfectly suited for large, multi-site trials as well as the one-site, ad-hoc research project.
Filemaker Pro is a custom development software package. You can build a system to be exactly what you need. An application developed in Filemaker Pro can be deployed in a variety of ways such as single user, peer-to-peer or server hosting. When Filemaker Pro clients are used in conjunction with Filemaker Pro server the transfer of data can be encrypted with SSL (Secure Socket Layer). Data can also be shared using ODBC (Open Database Connectivity) or additional plug-ins that allow data to be shared over the web. Data stored in a Filemaker Pro database can be protected by defining accounts and privilege sets. Each account specifies an account name and password for each individual or group. The privilege set determines the level of access an account has to the data.
The QDS™ Questionnaire Development System is a complete system
for developing and administering data collection applications. QDS™ enables
you to: produce all materials needed to administer a questionnaire
or complete a form from a single set of specifications and easily reuse
field-tested questions by copying specifications between questionnaires.
The QDS™ system consists of several components, or Modules. A module is one of the components, or executable programs (*.EXE), that make up the Questionnaire Development System.
The first step in creating a QDS™ application is to define questionnaire specifications in the Design Studio. Your specifications include all content and settings for your questionnaire—e.g., question text, instructions, branching instructions, consistency checks.
The Design Studio is also used to build instrument documentation, including hard-copy questionnaires (self- or interviewer-administered), an Analytical Codebook, and a log of all changes made to your Specifications File (Change History).
Data Collection Modules
QDS™ supports both manual and computer-administered data collection. Each type of data collection—Data Entry, ACASI, CAPI,—is associated with its own data collection module.
Data Entry Module
The QDS™ Data Entry module is used to key data originally collected on a paper form. The Data Entry module supports double entry (also called key verification or double keying) for increased quality assurance.
CAPI (Computer Administered Personal Interview)
The QDS™ CAPI module allows interviewers to conduct face-to-face interview using the computer. The computer displays one question at a time and allows the interviewer to enter responses in real time using the keyboard, mouse, and/or touch screen. Entering the data into the computer at the time of data collection eliminates the need for a separate data entry step. The CAPI module allows you to include information/probes for the interviewer.
ACASI (Audio Computer Administered Self Interview)
The QDS™ ACASI module allows the respondent to be "interviewed" by computer. The computer displays one question at a time and allows the respondent to enter responses using the keyboard, mouse, and/or touch screen. You may choose to have the computer read the questions and responses to the respondent using a computer text-to-speech engine or recorded WAV files. Entering the data into the computer at the time of data collection eliminates the need for a separate data entry step. Because no interviewer is required to conduct an ACASI interview, use of ACASI allows a single staff member to supervise multiple interviews. ACASI is also useful for providing a private setting for sensitive information.
Once data are collected/recorded using one or more of the Data Collection modules, you may import the data into the Warehouse Manager for data management and export data for analysis.
You must pay a license fee for each module. Current prices as of 6/29/07 are per install
Design Studio - $295
Data Entry - $295
ACASI - $495
CAPI - $495
Wherehouse manager - $495
At ISAP we have a 3 Tier approach after the instruments have been programmed:
Tier-1: Set of inbox for data warehouse. A secure storage for interviewers to load data into the ISAP Network. Installation of QDS software and support. Provide naming and coding conventions for data collection and storage.
Tier-2: Copying, reconciliation. Create QDS warehouse and harvest interviews from Inbox. If at any point the QDS program is changed then the interviews need to be converted to a standard form.
Tier-3: Export files to SPSS, run frequencies for data integrity. Provide error checking and feedback to interviewer for data cleaning. Create master file for ISAP use and archiving.