The NIH Collaboratory’s Biostatistics and Study Design Core has released the first in a series of guidance documents focusing on statistical design issues for pragmatic clinical trials. Each of the four guidance documents are intended to help researchers by providing a synthesis of current developments in the field, discuss possible future directions, and, where appropriate, make recommendations for application to pragmatic clinical research.
A new Living Textbook topic chapter, “Electronic Health Records-Based Phenotyping,” has just been published. The chapter defines computable phenotypes and describes their role in data queries of electronic health records as part of pragmatic clinical trials. A main focus of the chapter is outlining mechanisms for identifying and evaluating phenotype definitions, with particular emphasis on standardization efforts of the NIH Collaboratory, including the Table 1 Project. Also included are links to recommended phenotype definitions from the Collaboratory Phenotypes, Data Standards, and Data Quality Core.
A new Living Textbook topic chapter, “Learning Healthcare Systems,” has just been published. The topic includes background information on the creation and evolution of the concept of the learning healthcare system and the key attributes that define such systems, as described by the Institute of Medicine:
A learning healthcare system is [one that] is designed to generate and apply the best evidence for the collaborative healthcare choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and to ensure innovation, quality, safety, and value in health care .
Also included in the topic chapter are ethical and regulatory implications for learning healthcare systems, patient and public engagement, the application of electronic heatlh records and other information technology, logistical and organizational challenges to bulding learning healthcare systems, and early examples of such systems in practice.
1. Institute of Medicine. The Learning Healthcare System: Workshop Summary. Olsen L, Aisner D, McGinnis JM, eds. Washington, DC: National Academies Press; 2007. Available at: http://www.iom.edu/Reports/2007/The-Learning-Healthcare-System-Workshop-Summary.aspx. Accessed April 4, 2014.