Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need.

The current system of biomedical innovation is unable to keep pace with scientific advancements. We propose to address this gap by reengineering innovation processes to accelerate reliable delivery of products that address unmet medical needs. Adaptive biomedical innovation (ABI) provides an integrative, strategic approach for process innovation. Although the term "ABI" is new, it encompasses fragmented "tools" that have been developed across the global pharmaceutical industry, and could accelerate the evolution of the system through more coordinated application. ABI involves bringing stakeholders together to set shared objectives, foster trust, structure decision-making, and manage expectations through rapid-cycle feedback loops that maximize product knowledge and reduce uncertainty in a continuous, adaptive, and sustainable learning healthcare system. Adaptive decision-making, a core element of ABI, provides a framework for structuring decision-making designed to manage two types of uncertainty - the maturity of scientific and clinical knowledge, and the behaviors of other critical stakeholders.

Plasma erythropoietin in polycythemia.

Erythropoietin titers of plasma cannot be used to differentiate polycythemia vera from secondary polycythemia since the limit of sensitivity of our current bioassay technics is 50 mU, considerably higher than levels found in normal subjects and in patients with polycythemia. However, erythropoietin is relatively heat stable, and since abundant plasma is available from therapeutic phlebotomies it is possible to prepare and assay highly concentrated, erythropoietin-containing extracts. In 35 normal subjects, erythropoietin levels ranged from less than 5 mU/ml (the limit of sensitivity) to 18 mU/ml with a mean of 7.8 mU/ml. In 21 patients with proved polycythemia vera, the levels were less than 5 mU/ml in all. In 41 patients with suspected secondary polycythemia or polycythemia of unknown origin, the levels ranged from less than 5 to 3,000 mU/ml. Three of the 11 patients with levels less than 5mU/ml were subsequently shown to have polycythemia vera. These results suggest that this refinement of the routine bioassay for erythropoietin may be of clinical importance in the differential diagnosis of polycythemia.

Health of older women.

Older persons are the fastest growing segment of the American population, and older women significantly outnumber men. The health status of older women is influenced by disease and psychosocial factors. Comprehensive geriatric assessment is a tool which takes into account the many aspects of health and provides a framework for developing individualized goals of care. Cardiovascular disease, osteoporosis, hormonal treatment, urinary incontinence, mental health, sexuality, substance abuse, cancer and exercise are discussed.

An interactive learning environment for health care professionals.

This article summarizes experiences to date with building and deploying a clinical simulator that medical students use as part of a 3rd year primary care rotation. The simulated microworld helps students and health care professionals gain experience with and learn meta-cognitive skills for the care of complex patient populations that require treatment in the biopsychosocial-value dimensions. We explain lessons learned and next steps resulting from use of the program by over 300 users to date.

PC CLIN-SIM: a toolbook based clinical simulation environment.

The Departments of Computer Medicine, Health Care Sciences, Medicine, and Electrical Engineering & Computer Science at the George Washington University have joined forces to create a clinical simulation program. The purpose of this program is to provide experience in the management of complex patient populations (eg geriatrics). A number of simulation programs are available commercially, however none provide adequate geriatric content, or were deemed to lack functionality important to the developers. The immediate goal of this effort was to create a computer-based, core curriculum in geriatric medicine for medical and allied health students. The curriculum includes case simulations linked to a comprehensive reference database. The development objectives were to create an intuitive, friendly, consistent user interface which could serve as a shell for additional content areas. In order to increase fidelity, free text entry and time simulation were included.