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

Abstract

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.

Recruitment and Retention of Older People in Clinical Research: A Systematic Literature Review

“…Underrepresentation of older adults in clinical trials may be caused by several factors: Researchers often set arbitrary age limits [14][15][16][17][18] for ethical considerations 19 or are concerned about frailty. [20][21][22][23] However, even studies that report no explicit exclusion of older people by chronological age do not include enough older participants.…”

Translation and preliminary validation of an ageism scale for dental students in Brazil (ASDS‐Braz)

“…Additionally, ageism has a negative impact on the quality of healthcare provision to older adults, which leads to poor health outcomes . Older adults have generally been excluded from clinical trials, resulting in restricted applicability of the findings and a shortage of evidence‐based data to guide appropriate healthcare delivery . Therefore, ageism is one of the major barriers for older adults to receive age‐appropriate health care .…”

“Like Peanut Butter and Jelly”: A Qualitative Study of Chiropractic Care and Home Exercise Among Older Adults With Spinal Disability

“…Conversely, barriers to exercise, such as financial costs, transportation, scheduling, and co‐morbidities (42,43), also were identified as negative aspects of trial‐related treatment and may have impacted fidelity to study interventions for some participants. Future trials should be mindful to accommodate these needs among older adults and persons' decreased functional independence, and consider including these individuals when designing recruitment strategies and active care interventions, as these patient populations remain under‐represented in clinical trials for spine‐related disability (44).…”