Implications of ICD-10 for Sarcopenia Clinical Practice and Clinical Trials: Report by the International Conference on Frailty and Sarcopenia Research Task Force.

Establishment of an ICD-10-CM code for sarcopenia in 2016 was an important step towards reaching international consensus on the need for a nosological framework of age-related skeletal muscle decline. The International Conference on Frailty and Sarcopenia Research Task Force met in April 2017 to discuss the meaning, significance, and barriers to the implementation of the new code as well as strategies to accelerate development of new therapies. Analyses by the Sarcopenia Definitions and Outcomes Consortium are underway to develop quantitative definitions of sarcopenia. A consensus conference is planned to evaluate this analysis. The Task Force also discussed lessons learned from sarcopenia trials that could be applied to future trials, as well as lessons from the osteoporosis field, a clinical condition with many constructs similar to sarcopenia and for which ad hoc treatments have been developed and approved by regulatory agencies.

The role of quality in today's research university.

Today's research universities strive to meet goals in education, research, and service within an academic environment. A quality assurance and quality control program is critical to achieving excellence in all areas. However, the role of quality in research at higher education institutions is difficult to determine or consistently implement due to the broad nature of the research and academic goals. In addition, it is compounded by the loose organizational structure common to most universities. Formal quality assurance programs are not historically found at academic institutions. Faculty and staff often have neither the experience nor training in good quality assurance practices. Implementation of a formal quality assurance program is made more difficult by university space and financial limitations and a reward system based on peer-reviewed publications. A successful formal quality assurance program must be sufficiently flexible to meet all needs, must focus on those needs, and must be willingly supported by all participants. The Institute of Wildlife and Environmental Toxicology (TIWET) at Clemson University in South Carolina has implemented a quality assurance program designed to comply with several quality assurance regulations, including the good laboratory practice (GLP) standards. The program relies on study protocols or plans, standard operating procedures (SOPs), data collection forms, a quality assurance manual, quality assurance checklist/plans, and a quality assurance unit. The program maximizes flexibility while complying with several quality regulations and consensus standards. Since implementation, improvements in communication, study design, data recording, and reporting have been noted.(ABSTRACT TRUNCATED AT 250 WORDS)