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Medical Research Finds the Right Solution

January 31, 2003

Confronted with the need to improve the processing of research data, Childrens Hospital Los Angeles (CHLA) opted for a solution based on Cardiff Software's TELEform information capture software and PDF+Forms, the industry standard for creating and processing digital forms in using Adobe PDF. This powerful combination enabled CHLA to streamline information processing, save time and money, protect patient privacy, and bridge the disparity between doctors who have made the transition to computers and those who still use paper forms.

About CHLA
Founded in 1901, CHLA is a global resource for advanced pediatric care. The hospital averages 180,000 patient visits yearly and also has a large training program for pediatric specialists. Affiliated with the University of Southern California School of Medicine since 1932, CHLA operates an internationally noted research program that has focused on five major pediatric areas: cancer, genetics, neuroscience, cell biology, and immunology.

The Challenge
Earl Leonard, Bio-statistician for the CHLA Research Institute, faced a typical data-processing problem. As a consultant to faculty and staff research groups throughout the hospital, Leonard establishes and manages data collection procedures and research databases. Leonard's team typically processes forms for 10 research studies at a time, which results in about 100 forms a day. A current typical study of sickle cell anemia events, for example, has a total of 120 patients and 5,500 visit records.

Prior to automating data entry, a paper form was the only method of data collection. During patient visits, doctors would fill in forms by hand and send them to the Research Institute. At the Research Institute, temporary data entry clerks manually keyed the data into the clinical research database, which was developed using Oracle. Because of inconsistencies in the number of studies conducted over any given timeframe, Leonard had to estimate the number of temporary clerks he would need. Over and above the hard costs of this temporary labor, Leonard spent an inordinate amount of time managing the hiring process and training each new temporary clerk.

The CHLA Research Institute also faced a major challenge when confronted with conducting retrospective analyses, which use data from archived medical charts as a research and management tool. The traditional method for a retrospective analysis was to physically review thousands of forms at the Medical Record Center, which does not allow charts to be removed from the premises. Researchers were forced to transcribe data onto paper, then key collected data into a database application. This time and labor-intensive process strained the resources of the department, making some important studies impractical.

Finally, CHLA Research Institute needed a way to manage the process of sharing research data stored within the Oracle database without disclosing proprietary patient data - all without any additional budget to hire a professional Oracle database programmer.

Finding a Solution
"We investigated several products," said Leonard, "but liked the features and price of TELEform. We bought a standalone version, ran some tests, and were very impressed with the conversion of paper forms into data for our Oracle system. By adding Cardiff PDF+Forms, we've also been able to leverage email and the Internet as a data collection tool."

The Research Institute now runs TELEform Enterprise with two Designers, two Readers, and five Verifiers, and uses the PDF+Forms add-on. For each research test, a specific form is printed and distributed to doctors, and is also made available electronically. The forms are one to three pages long, supporting check boxes, comments, and handwritten numeric entries, such as temperature, height, weight, and blood pressure. Using a single product, the Research Institute supports automated data collection and processing from both paper and online forms.

The collection process is very flexible. Paper forms can be faxed using a Hewlett Packard Digital Sender, or scanned on site. Online versions of the forms can be processed from a Web site, or sent via email. In both cases the collected data is automatically processed and verified by TELEform, output to a Microsoft Access database, and linked by specific keys to the patients within the existing Oracle database. The data in Microsoft Access can then be shared without compromising confidential patient information.

The Benefits
The business benefits of the TELEform and PDF+Forms combination have been tremendous. Said Leonard, "We have eliminated the need to hire more and more data entry clerks at around $80 per person per day. Instead we can allocate our resources better, so we save time and money and are more productive. And thanks to the accuracy of the PDF-based forms, fewer 'bad' forms are collected, further increasing our processing speed and accelerating access to valid data."

The solution has also enabled the Research Institute to handle retrospective studies easily. "Now we just take a laptop down to the Medical Record Center, enter the data directly into our eForms, then automatically process the entire batch when we return to the office. In fact we were recently able to completely process and verify 5,000 forms in just 3 days. Without PDF+Forms, it would have taken months to accomplish this."

Leonard also likes the way the TELEform solution lets him collect data seamlessly from multiple facilities when collaborating on a study. "The data can be faxed or emailed from anywhere, so it's very fast and organized."

PDF+Forms delivers two additional benefits that Leonard finds invaluable. First, PDF+Forms has the ability to black out a field during printing, and blank out non-active fields on a computer screen. "When conducting research with patient information," said Leonard, "we are very concerned about privacy issues. PDF+Forms allows us to print our research data while completely hiding a patient name. Even when an operator is verifying data, the name isn't visible on the computer screen. It's an extremely important feature."

Finally, PDF+Forms is helping Leonard solve the biggest challenge in making the shift to electronic forms processing. "Many of our doctors aren't comfortable using a computer to enter research data, and still prefer to enter the data onto a paper form. PDF+Forms allows me to use an identical form whether on paper or on the computer. As doctors become more and more comfortable with the computer, they can simply transition to the electronic version of the same form. Since the forms look identical, it's a seamless conversion. This allows us to evolve toward full electronic submission without penalizing the doctors still working with paper.

Looking to the Future
Along with continuing to move toward a higher and higher percentage of electronic data submissions, Leonard is planning to connect his TELEform solution directly to a complete, separate data warehouse. "We've really solved the data collection challenges," said Leonard. "Next comes improving access to all of our collected data." Cardiff Software

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