Exclusion of Older Adults from Ongoing Clinical Trials on Low Back Pain: A Review of the WHO Trial Registry Database.
ageism
clinical trial
low back pain
qualitative research
therapeutics
Journal
Journal of the American Geriatrics Society
ISSN: 1532-5415
Titre abrégé: J Am Geriatr Soc
Pays: United States
ID NLM: 7503062
Informations de publication
Date de publication:
03 2019
03 2019
Historique:
received:
21
06
2018
revised:
04
10
2018
accepted:
06
10
2018
pubmed:
12
12
2018
medline:
19
3
2020
entrez:
12
12
2018
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
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.
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
603-608Informations de copyright
© 2018 The American Geriatrics Society.