NDLI: Temporal changes in characteristics and external validity of randomized controlled trials in older people from 2012 to 2019

Content Provider	Springer Nature : BioMed Central
Author	van Eijk, Estelle van der Spek, Yanna M. van Deudekom, Floor J. A. van den Bos, Frederiek Mooijaart, Simon P. Trompet, Stella
Abstract	Background Older individuals are often underrepresented in clinical trials. In 2012 only 7% of RCT’s specifically studied older people and their geriatric characteristics were poorly reported. The aim of this review was to investigate temporal changes in characteristics and external validity of randomized controlled trials in older people from 2012 to 2019. Methods PubMed was searched for randomized clinical trials (RCTs) published in 2019. Firstly, the proportion of RCTs specially designed for older people were determined by the following criteria: a reported mean age of ≥ 70 years or a lower age cutoff of ≥ 55. Secondly, the trials with a majority of older people, defined by a reported mean age of ≥ 60 years, were screened for reporting of geriatric assessments. Both parts were compared with identical reviews performed in 2012. Results From a 10% random sample, 1446 RCTs were included in this systematic review. First, 8% of trials were specifically designed for older people in 2019 compared to 7% in 2012. Secondly, 25% of the trials included a majority of older people in 2019, compared to 22% in 2012. Thirdly, in 52% of these trials in 2019 one or more of the geriatric assessments were reported compared to 34% in 2012. Conclusions Although in 2019 the proportion of published RCTs specifically designed for older people remains low, more characteristics on geriatric assessments were reported compared to 2012. Continued efforts should be paid to increase both the number and the validity of trials for older people.
Related Links	https://bmcgeriatr.biomedcentral.com/counter/pdf/10.1186/s12877-023-04018-6.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
ISSN	14712318
DOI	10.1186/s12877-023-04018-6
Journal	BMC Geriatrics
Issue Number	1
Volume Number	23
Language	English
Publisher	BioMed Central
Publisher Date	2023-05-24
Access Restriction	Open
Subject Keyword	Geriatrics Gerontology Aging Rehabilitation Geriatric assessments Temporal changes Older individuals Systematic review Randomized controlled trials Geriatrics/Gerontology
Content Type	Text
Resource Type	Article
Subject	Geriatrics and Gerontology
Journal Impact Factor	3.4/2023
5-Year Journal Impact Factor	4.1/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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