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233 Development of Software Systems to Facilitate the Use of Electronic Data Records in the Collection of Population-Based Cancer Surveillance Data

Number of anticipated awards: 1-2
(Fast-Track proposals will not be accepted.)
Budget (total costs): Phase I: $150,000;
Phase II: $750,000

The deadline for receipt of all contract proposals submitted in response to this solicitation was:
5:00 p.m. Eastern Standard Time
Monday, November 6, 2006

The goal of this project is to expand on the present utilization of electronic pathology records in the collection of population-based cancer surveillance data to include electronic records from the other data sources necessary to support overall data collection requirements.

The Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute is an authoritative source of information on cancer incidence and survival in the United States. The SEER Program currently collects and publishes cancer incidence and survival data from 15 population-based cancer registries and three supplemental registries covering approximately 26 percent of the U.S. population. The SEER database contains information on more than 6 million in situ and invasive cancer cases with approximately 360,000 new cases accessioned each year. The SEER registries routinely collect data on patient demographics, primary tumor site, morphology, histology, extent of disease, stage at diagnosis, first course of treatment, and follow-up for vital status.

About 95% of cancers are first identified through pathology reports, from either hospital based or independent laboratories. A complete cancer record for any given cancer in the SEER database consists of 1) pathology reports that provide key characteristics of the cancer required for its classification, 2) hospital medical records, and 3) other numerous reports (surgical, imagining, treatment) from multiple institutions. Historically, this data gathering has been performed manually, either by cancer registrars from the central registry, who travel to the various data sources and abstract reports, or by relying on hospital-based cancer registrars who forward their reports to a central registry. These methods are labor-intensive, time-consuming, and may result in data of varying quality and completeness.

Although many data sources are available in electronic format, to date, with the exception of an ongoing effort to utilize electronic pathology reports (E-Path) in case finding, no other electronic data are captured for cancer registries. No mechanism exists for searching electronic health records at their source, selecting those which relate to a reportable cancer, applying the appropriate codes to the relevant data fields and transmitting both the appropriate records and coded data to the responsible central cancer registry. Utilization of electronic records in the reporting of cancer surveillance data has the potential to improve data quality and completeness by removing the laborious, time-consuming manual data collection effort currently in place (1-7).

The key to improving the cancer surveillance system in the U.S. is the timely collection and integration of patient information from multiple sources within a medical care environment and across multiple institutions. An electronic central cancer registry opens the possibilities of adding additional information such as results of emergent biomarker tests and treatment information.

Processing the new electronic records would be similar to how the electronic pathology reports are processed. Modifications would involve changes to both the report generation and extraction, data translation, report selection and transmission, and coding system, which would require unique solutions dependent on the source of the case data (for example, medical record, diagnostic imagining, etc.).

Phase I Activities and expected deliverables:

• From the various available record sources (e.g., medical records, billing claims records, surgical reports, treatment reports, etc.), determine which are available electronically to large hospital or independent cancer treatment centers.
• From what is available electronically, evaluate which source(s) would be most beneficial to central registry reporting. Examples of benefits include, but are not limited to 1) capturing limited data in a much more timely fashion, 2) capturing a category of data more reliably and completely, or 3) other ways of enhancing cancer registration in a cost and time effective way for personnel.
• Determine which software products currently provide for processing of text-based medical data from one or more sources within a hospital which may serve as a platform for expansion into the selected record source(s). For example, a system which performs a natural language parsing of medical claims data to select cases where patients have been discharged following bypass surgery, may be modifiable to select for cancer discharges.
• Convene focus groups or conduct interviews with potential end-users of the system to determine if the system contents, format, etc. are appropriate for ease of use.
• Develop a working prototype of the system.
• Include travel funds to present Phase I findings and demonstrate product prototype to an NCI Evaluation Panel.

Phase II Activities and expected deliverables:

• For the selected record source, develop the standards for the transmission of the electronic health records (entailing both an HL7 and a text file standard) from their source to the central cancer registry. These standards currently do not exist for any potential source. An effort is currently underway to establish standards for the transmission of reportable pathology reports from the laboratory to the cancer registry (8).
• For the selected record source, develop the rules needed to select the potentially reportable records from the data source. The rules necessary for the selection of potentially reportable pathology reports will not be the same as those for various other source reports. Each report source (such as the diagnostic imaging report, hospital medical record, surgical report, etc.) requires a different set of rules and requirements which must be identified and tested. The electronic pathology systems have the ability to transform English text into machine readable codes corresponding to required standardized medical nomenclatures, however, these systems only relate to the information found within a pathology report and must be expanded as additional source records are to be processed.
• For the selected record source, development of a demonstration system which can receive the transmitted source records, parse the report text, and utilizing the rules developed for the selection of reportable cancer cases, select the appropriate records.
• Describe Universal Modeling Language (UML) models of all architecture components.
• Develop the final software product that implements the market-validated features, functions and requirements developed in Phase I.
• Demonstrate the sensitivity and specificity of reportable case selection in the range currently demonstrated in electronic pathology systems - 98-99% range for both sensitivity and specificity. Evaluate the use of the final software with potential end-users.
• Provide the technical documentation of the system, including UML models, system architecture, programming interfaces, and supporting software requirements.
• Identify Phase II barriers to evaluating the impact of the software and resolutions to these barriers.
• In the first six months of the first year of the contract, provide the program and contract officers with a letter of commercial interest.
• In the first six months of the second year of the contract, provide the program and contract officers with a letter of commercial commitment based on the successful outcome of the Phase II.
• Include $24,000 in the budget for an independent vendor to evaluate the final product.
• Include sufficient travel funds for the P.I. to participate in an NCI/DCCPS SBIR Showcase.
• Prepare at least one manuscript describing the development and evaluation of the product for publication in a peer-reviewed scientific journal.
• Submit final report in the template provided by the NCI program officer.

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