The National Heart, Lung, and Blood Institute (NHLBI) convened a working group of investigators on June 22, 2012, to discuss the development and application of point-of-care (POC) technologies as tools for diagnosis and monitoring in the clinical cardiovascular (CV) research setting. Working group members provided the NHLBI with a list of recommendations for research to advance the field.
The working group is responsive to NHLBI Strategic Plan Goals 1, 2, and 3.
POC technologies are becoming valuable tools for the diagnosis and management of several CV diseases, including congestive heart failure and acute coronary syndromes. They offer major benefits when the output of POC testing is used in conjunction with electronic medical records and when it is combined with goal-directed therapy. The use of POC technology enables:
- Monitoring over time and real-time detection of clinical laboratory measures/biomarkers
- Standardization of phenotype measurements
- Rapid, standardized, and cost-effective diagnosis
- Improved throughput of tests, decreased turn-around times for results, and decreased time lag to starting treatment
- Enhanced communication of test results to multiple parties
- Potential cost efficiencies and improved clinical outcomes
POC technologies may contribute pivotally to personalizing medicine, improving healthcare delivery, and ultimately reducing healthcare costs. Moreover, some of the tools being developed for clinical application could be put to use for clinical research and trials. POC-related tools and technologies could facilitate clinical research by enabling easier identification of eligible patients for recruitment, expedited collection of baseline and follow-up measurements, more rapid and appropriate deployment of interventions, better quality control, and closer monitoring of study compliance. Onsite tools and technologies would help researchers and clinicians to assess, predict, and/or diagnose CV conditions readily and inexpensively, without reliance on complex, time-consuming tests and measurements.
Working Group Discussion
The working group defined POC testing as convenient and immediate clinical diagnostic and laboratory testing at or near the site of patient care. It involves the use of portable, transportable, handheld instruments and analysis test kits.
The discussion addressed several issues pertaining to the use of POC technologies in CV clinical research, including barriers to use, technological challenges and needs, use in remote populations, translation and implementation, regulatory challenges, and ethical, legal, and social implications. The group considered many factors affecting the use of POC devices in CV research, including opportunities to use existing devices, validation of the devices, and steps needed to implement them in a clinical setting. Additionally, the group discussed the research gap between the development of POC technologies and their application to public health. Participants also considered the potential benefits of new POC technologies such as cost effectiveness, personalized therapy, and utility for testing clinical research hypotheses. Several barriers to implementing the clinical use of POC technologies were identified, such as the needs for regulatory guidance and for technical integration at all levels from development to use, and ethical concerns.
Working Group Recommendations
The working group recommended several NHLBI actions to advance POC technology development and implementation for use in clinical CV research:
- Convene a larger working group of stakeholders (NHLBI staff, regulators such as the FDA, industry, academic investigators, and clinicians) to establish a roadmap for development of POC technologies for research
- Support a balance of small proof-of-concept studies and larger validation studies
- Proof-of-concept studies would help to determine reference values for POC tests in relevant populations and in individuals and to encourage harmonized data standards and reporting of POC tests.
- Larger-scale prospective studies would determine the data and integration needs at different levels (e.g., technical, systems, patient, population) and would support POC tests that demonstrate outcomes in clinically relevant samples.
- Support POC technology development/enhancement and development of integrated devices for POC measurements
- Develop standards for clinical use of POC tests and assess effectiveness of using home testing and onsite POC devices for research purposes
- Support ancillary studies that use POC technologies in ongoing or planned clinical research projects funded by the NHLBI
- Provide access to biobanks and existing clinical data for use in ancillary studies
The working group also suggested that the NHLBI:
- Work closely with regulatory agencies and other organizations to obtain their input regarding regulatory pathways to facilitate R&D, commercialization, and eventual integration into clinical practice
- Coordinate efforts with other NIH Institutes and Centers that are interested in POC technology research and development
- Facilitate the training of individuals in POC technology development and research application
The working group plans to prepare a short manuscript for publication in a peer-reviewed journal.
Dina N. Paltoo, PhD, MPH
NHLBI, NIH, DHHS
Erin Iturriaga, RN, BS
NHLBI, NIH, DHHS
Working Group Participants
Peter Libby, MD
- Fred Apple, PhD
- Paddy Barrett , MD
- Robert Califf , MD
- Paula Caposino , PhD
- Hilary Leeds, JD
- Luanda Grazette, MD, MPH, FACC
- Paul Gurbel , MD
- Jonathan Linder, MD
- John McDevitt, PhD
- Shuqui Chen, PhD
- Ralph Weissleder, MD, PhD
- Samuel Sia, PhD
- Bishow Adhikari, PhD
- Narasimhan Danthi , PhD
- Patrice Desvigne-Nickens, MD
- Zorina Galis, PhD
- Anupama Rao, MD
- William Riley, PhD
- Pothur Srinivas, PhD, MPH
Last Updated: February 2013