Exclusion of Older Adults from Ongoing Clinical Trials on Low Back Pain: A Review of the WHO Trial Registry Database.

BACKGROUND/OBJECTIVES: The burden of low back pain (LBP) is high, especially for older adults who experience a higher number of years living with a disability. However, this population is not being well represented in clinical trials (CTs). This study analyzed the International Clinical Trial Registry Platform (ICTRP) database from the World Health Organization to verify the future trend in the participation of older adults in registered CTs on LBP. DESIGN: We performed a cross-sectional review of the ICTRP searching for prospective protocols planning interventions for LBP with registration dates from January 2015 through November 2018. From the protocols of the eligible studies, we extracted those planning to include older adults. RESULTS: A total of 167 protocols for CTs for LBP were planning to recruit participants older than 65 years. However, only five registries (2.99%; pooled sample = 169 participants) were designed to target participants specifically older than 65 years. The exclusion of older participants was not justified and imposed through an arbitrary upper-age limit in 93.6% of the protocols. Most of the protocols are from single-center studies, and a greater number are planned to be carried out in developed regions. Higher interest was in pharmacologic interventions, devices/technology, and physical rehabilitation. CONCLUSION: Older adults with LBP will continue to be underinvestigated in CTs for LBP in the near future. In general, ongoing trials are small, planned in developed regions, and proposing pharmacologic interventions to deal with LBP. J Am Geriatr Soc 67:603-608, 2019.

How do we define and measure sarcopenia? Protocol for a systematic review.

BACKGROUND: The loss of muscle mass is a natural aging consequence. A reduction of muscle mass that surpasses the physiological rate is considered the key factor responsible for the development of a geriatric syndrome called sarcopenia. However, a new understanding of the importance of muscle quality over quantity is rising; as a result, different definitions for sarcopenia has been used. Due to the negative impact on elder's health and quality of life, the number of research investigating the causes, prevalence, and management of sarcopenia is increasing, although a consensus on sarcopenia definition is still missing. This systematic review will assess observational studies reporting the presence of sarcopenia aiming to verify how sarcopenia is defined, the diagnosis criteria, and the tools used for assessment. In addition, we will investigate the influence of the definition and diagnostic tools on the prevalence rate. METHODS: Keywords related to the condition, population, and type of study will be combined to build a search strategy for each of the following databases MEDLINE, EMBASE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Web of Science, and Google Scholar. Two independent reviewers will analyze the retrieved papers for eligibility and the methodological quality of eligible studies. The definition of sarcopenia and diagnostic tools used in each study and the prevalence estimates will be extracted. Descriptive statistics will be used to report the definitions of sarcopenia, diagnostic tools, and whether these influence or not, the prevalence rates. DISCUSSION: Sarcopenia is receiving greater attention in geriatrics research in recent years. Therefore, it is important to investigate how this condition is defined in the literature and whether these definitions can interfere with the reported estimates devoting more efforts on the topic. The results of this study can help to determine the most used definitions of sarcopenia reported in the literature, its strengths and limitations, and open a discussion about a need for a more valid, easy, and suitable one. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015020832.