Age-based exclusion is common and multifactorial in spinal RCTs: a systematic review and quantitative analysis.

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Abstrakt

Tytuł:: Age-based exclusion is common and multifactorial in spinal RCTs: a systematic review and quantitative analysis.
Autorzy:: Chew G; Faculty of Medicine, University of New South Wales, Wallace Wurth Building (C27), Cnr High St and Botany St, Kensington, NSW, 2052, Australia.; Spine Labs, 10 South St, Kogarah, NSW, 2217, Australia.
Menounos S; Faculty of Medicine, University of New South Wales, Wallace Wurth Building (C27), Cnr High St and Botany St, Kensington, NSW, 2052, Australia.; Spine Labs, 10 South St, Kogarah, NSW, 2217, Australia.
Sheldrick K; Faculty of Medicine, University of New South Wales, Wallace Wurth Building (C27), Cnr High St and Botany St, Kensington, NSW, 2052, Australia.; Spine Labs, 10 South St, Kogarah, NSW, 2217, Australia.
Das A; Faculty of Medicine, University of New South Wales, Wallace Wurth Building (C27), Cnr High St and Botany St, Kensington, NSW, 2052, Australia.; Spine Labs, 10 South St, Kogarah, NSW, 2217, Australia.
Diwan AD; Faculty of Medicine, University of New South Wales, Wallace Wurth Building (C27), Cnr High St and Botany St, Kensington, NSW, 2052, Australia. .; Spine Labs, 10 South St, Kogarah, NSW, 2217, Australia. .
Źródło:: European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society [Eur Spine J] 2023 May; Vol. 32 (5), pp. 1537-1545. Date of Electronic Publication: 2023 Mar 07.
Typ publikacji:: Journal Article; Systematic Review; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Original Publication: Heidelberg, Federal Republic of Germany : Springer-Verlag, c1992-
MeSH Terms:: Randomized Controlled Trials as Topic*
Patient Selection*
Spine*/pathology
Age Factors*
Aged ; Aged, 80 and over ; Female ; Humans ; Middle Aged
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Contributed Indexing:: Keywords: Age-based exclusion; Ageism; Interventions; Research; Spine
Entry Date(s):: Date Created: 20230307 Date Completed: 20230524 Latest Revision: 20231031
Update Code:: 20240104
DOI:: 10.1007/s00586-023-07618-3
PMID:: 36881142
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Most diseases of the spine disproportionately impact older persons, with the modal (i.e., commonest) patient a female in their 8th decade of life. We examined the corpus of spinal RCTs to determine how many included "average" spine patients. We searched PubMed for randomized clinical trials published in the top 7 spine journals over a period of 5 years from 2016 to 2020 and extracted nominal upper age cut-offs and the distribution of ages actually recruited. We identified 186 trials of 26,238 patients. We found that only 4.8% of trials could be applied to an "average" 75-year-old patient. This age-based exclusion was not dependent on funding source. Age-based exclusion was exacerbated by explicit upper age cut-offs, however, the age-based exclusion went beyond explicit age cut-offs. Only few trials were applicable to older patients even amongst trials with no age cut-off specified. Age-based exclusion from clinical trials starts at late middle age. The mismatch between spinal patient's age seen in clinical practice and spinal patient's age in trials was so severe that over the 5 years (2016-2020) almost no RCT evidence was produced applicable to the "average" aged-patient across the body of literature available. In conclusion, age-based exclusion is ubiquitous, multifactorial, and happens on a supratrial level. Eliminating age-based exclusion involves more than an arbitrary lifting of explicitly stated upper age cut-offs. Instead, recommendations include increasing input from geriatricians and ethics committees, establishing updated or new models of cares, and creating new protocols to facilitate further research.
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