Small Business Innovation Research (SBIR) Contract

SBIR 212: Integrating Patient-Reported Outcomes in Clinical Oncology Practice

View information about the RFA and instructions on how to apply for the SBIR contract

The proposal receipt date is November 5, 2004. Fast-Track proposals will be accepted.

Numerous reports have identified the need to improve the management of symptoms and quality of-life-problems in cancer patients whether these problems are related to treatment or the course of disease. Addressing this issue, the short-term goal of this project requires the offeror to develop integrated, ongoing patient-reported outcome (PRO) measurements to provide timely, efficient, individualized information for monitoring patient progress and improving decision making in routine oncology patient care. The long-term goal is to develop computerized PRO data measurement and information systems for use by clinicians and patients that include cancer-specific symptoms and quality-of-life domains using well-validated instruments or item banks and computer adaptive testing administration to gather patient-reported data for use in clinical practice.

Such systems are intended to facilitate collection of information from patients via alternative delivery platforms, such as telephones, computers, handheld devices, and the Internet at selected or patient-determined intervals (not only at the time of a patient visit). Health status reports for both patients and clinicians need to be screened for urgency and tailored to their preferences and knowledge in a standardized format that can be integrated with medical records data, evidence-based guidelines, and resources for responding to patient needs. Data collection that meets privacy and confidentiality concerns will be used not only for patient care, but also to develop norms for clinician use and for research.

The systematic use of PRO information to guide care is accepted by clinicians in theory but does not occur in routine oncology practice in the U.S. (Donaldson, M.S., "Taking Stock of Health-Related Quality of Life Measurement [HRQOL] in Oncology Practice in the United States," in press, JNCI). Although much methodological instrument development has occurred, and feasibility studies collecting data in conjunction with the patient visit have shown improved patient-clinician communication, many challenges to widespread adoption still exist. These challenges include general clinician belief that instruments are not adapted for efficient use at the individual (rather than clinical trial) level. The use of HRQOL in routine practice requires acceptance by clinicians, patients, and administrators, timely communication among all who provide care, efficient data collection, analysis, and reporting and resources for responding to identified patient problems. For patients, it will require addressing the acceptability of PRO assessment in light of response burden and possible concerns about confidentiality. Importantly, patients will expect that data they provide will help to improve their care. The way forward, however, does not lie simply in adding PRO measurement to other clinician tasks such as the occasional, time-limited patient visit. Rather, effective implementation will require new information infrastructures and technologies to embed the timely, routine use of PRO information in the care process. In particular, a key objective is to uncouple outcomes measurement from the strictures of the patient visit -- an opportunity provided by information technologies.

The rapid deployment and public acceptance of information technologies and networks offer an opportunity for developers to incorporate information about cancer patient functioning with clinical records. Such systems would provide as-needed reports to patients and treating clinicians to assist in informed decision-making to improve cancer care. Health status reports can be tailored to the preferences and knowledge of the patient and clinician and may include graphical display of health status over time as well as identifying the need for clinical attention. Clinicians may wish to respond by e-mail, phone, or other means, rather than by patient visit only. Such tracking may help patients become more involved with their own care as do dieters who keep food records.

The NIH RoadMap initiative on Re-engineering the Clinical Research Enterprise has recognized the value added of advances in information technology and measurement theory to collect PROs by creating a 5-year $25 million RFA (RM-04-011) for the Dynamic Assessment of Patient-Reported Chronic Diseases Outcomes. This RoadMap project will revolutionize the way PRO data are administered and collected. However the survey items used to measure HRQOL will not be specific to cancer, but rather, will be selected to address a range of chronic diseases. Further, the focus of the RFA is to improve the monitoring of PROs for clinical research with only brief mention of improving care in the clinical practice setting. The clinical setting would be addressed only in late phases of the project or as an extension beyond the five-year term. There is need to act now to work with patients and oncologists to develop integrated information systems that focus on cancer care and implementation in practice settings so that products of the RoadMap initiative can be successfully incorporated into practice.

The ideal system should be adaptable to integrate with other data systems and be platform-independent (work across Windows, Mac, Unix, and other operating systems). PRO administration should be device independent, allowing patients to self-report via devices such as telephone, Internet, or handhelds. A flexible self-report system gives patients the freedom to choose a device that meets their preferences, schedule, or limitations. PRO data can be integrated with clinical information and reports tailored to user preferences. For oncologists, the report can profile patient functioning over time with clinically meaningful changes in health status highlighted for their attention. Such reports can include links to guidelines and treatment recommendations adapted for the individual patient, local practice, and available resources. Reports for patients can be in a format that is easily understandable for them to monitor their own progress and to indicate when they may need immediate care. De-identified PRO and clinical data could foster a better understanding of patterns of care and treatment effectiveness as well as to track changes in special populations and across tumor sites. Further, data could be used to update the data collection instruments to improve questionnaire properties and suggest research to narrow knowledge gaps.

Phase I Activities and Expected Deliverables

1. Conduct interviews, focus groups, clinical site visits and meetings among patients, clinicians, health care personnel, and information technology and PRO experts;
2. Perform literature reviews to determine the scientific and technical feasibility of creating and implementing such systems in practice settings;
3. Deliver a report detailing the program design and specification including a plan to integrate the PRO information system into a network of clinical practices;
4. Deliver a prototype of the PRO data monitoring, collection, and reporting infrastructure; and
5. Deliver agreements from cancer clinical settings to participate in testing and evaluation.

Phase II Activities and Expected Deliverables

1. Develop and integrate the information systems in clinical practices;
2. Create evaluation measures;
3. Evaluate and refine the program based on user feedback;
4. Create a manual, tutorial, and other educational materials designed to integrate this system in other clinical practices including cancer centers and community care settings -- addressing both technical implementation and social/cultural change management;
5. Deliver developed software to run the full system and track outcomes; and
6. Deliver at least one article describing the development and evaluation of the system that is suitable for publication in appropriate scientific journals.

Search | Contact Us | Accessibility | Privacy Policy