A systematic review of trends in the selective exclusion of older participant from randomised clinical trials

Thake, Miriam; Lowry, Andrew

doi:10.1016/j.archger.2017.05.017

Cited by 48 publications

(47 citation statements)

References 13 publications

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“…A study of 4341 RCTs published in four high-impact general medical journals found that 29% had upper age limits for inclusion that were rarely explicitly justified. Although the percentage of trials with upper age limits declined somewhat between 1998 and 2015, absolute change over time was small [22], and only 7% of RCTs published in 2012 were specifically conducted in older patients [23]. Of 319 ongoing RCTs for 10 common conditions registered with ClinicalTrials.gov in 2014, 79% excluded patients with common co-morbidities [24].…”

Section: Comparison With Other Literaturementioning

confidence: 99%

Exclusion rates in randomized controlled trials of treatments for physical conditions: a systematic review

Moralès

Guthrie

2020

Trials

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Background: The generalisability of randomized controlled trials (RCTs) can be uncertain because the impact of exclusion criteria is rarely quantified. The aim of this study was to systematically review studies examining the percentage of clinical populations with a physical health condition who would be excluded by RCTs of treatments for that condition. Methods: Medline and Embase were searched from inception to Feb 11th 2018. Two reviewers independently completed screening, full-text review, data extraction and risk-of-bias assessment. The primary outcome was the percentage of patients in the clinical population who would have been excluded from each examined trial. Subgroup analyses examined exclusion by population setting, publication date and funding source. Results: Titles/abstracts (20,754) were screened, and 50 studies were included which reported exclusion rates from 305 trials of treatments in 31 physical conditions. Estimated rates of exclusion from trials varied from 0% to 100%, and the median exclusion rate was 77.1% of patients (interquartile range 55.5% to 89.0% exclusion). Median exclusion rates for trials in common chronic conditions were high, including hypertension 83.0%, type 2 diabetes 81.7%, chronic obstructive pulmonary disease 84.3%, and asthma 96.0%. The most commonly applied exclusion criteria related to age, co-morbidity and co-prescribing, whereas more implicit criteria relating to life expectancy or functional status were not typically examined. There was no evidence that exclusion varied by the nature of the clinical population in which exclusion was evaluated or trial funding source. There was no statistically significant change in exclusion rates in more recent compared with older trials. Conclusions: The majority of trials of treatments for physical conditions examined excluded the majority of patients with the condition being treated. Almost a quarter of the trials studied excluded over 90% of patients, more than half of trials excluded at least three quarters of patients, and four out of five trials excluded at least half of patients. A limitation is that most studies applied only a subset of eligibility criteria, so exclusion rates are likely underestimated. Exclusion from trials of older people and people with co-morbidity and co-prescribing is increasingly untenable given population aging and increasing multimorbidity. Trial registration: PROSPERO registration CRD42016042282.

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Section: Comparison With Other Literaturementioning

confidence: 99%

Exclusion rates in randomized controlled trials of treatments for physical conditions: a systematic review

Moralès

Guthrie

2020

Trials

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“…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 .…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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Background and Objective Ageism is a major barrier for age‐appropriate care. The aim of this study was to translate and perform a preliminary validation of an ageism scale for dental students (ASDS) in Brazil (ASDS‐Braz). Methods The 27‐item original ageism scale was translated from English into Brazilian Portuguese. A panel of five Brazilian dental educators revised the scale to establish content validity. The translated version was completed by 156 dental students in the Federal University of Pelotas in Brazil. Principal component analysis, internal consistency reliability and discriminant validity were estimated. Results All items in the Brazilian Portuguese version received a content validity index score ≥0.80 indicating that they were relevant to the topic. The principal component analysis produced a 12‐item scale with three components that accounted for 51% of the overall variance. The first component contained six items associated with a negative view of older adults; the second component contained three items dealing with the complexity of providing care for older adults; and the third component contained three items associated with a positive view of older people. Discriminant validity did not show any differences related to demographic factors, the semester of studies and history of living with older people. Conclusions The preliminary validation of the ASDS‐Braz produced a 12‐item scale with three components with acceptable validity and reliability. Future research in a larger, multi‐institutional sample is now warranted.

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“…In geriatric medicine, the patients geriatric healthcare providers spend the most time caring for—the oldest, most complex—are underrepresented in research . While the prevalence of most chronic diseases increases with age, older adults are often excluded from research studies explicitly through age cutoffs or implicitly by excluding those with co‐occurring conditions .…”

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confidence: 99%

“…Key words: 5Ts; communication framework; inclusion of older adults; geriatrics research I n geriatric medicine, the patients geriatric healthcare providers spend the most time caring for-the oldest, most complex-are underrepresented in research. 1,2 While the prevalence of most chronic diseases increases with age, 3 older adults are often excluded from research studies explicitly through age cutoffs or implicitly by excluding those with co-occurring conditions. 4,5 For example, more than 50% of those with chronic kidney disease (CKD) are 70 years and older 6,7 ; however, this age group comprises less than 5% of the clinical trial populations on which many CKD Clinical Practice Guideline recommendations were based.…”

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The 5Ts: Preliminary Development of a Framework to Support Inclusion of Older Adults in Research

Bowling

Whitson

Johnson

2019

J American Geriatrics Society

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Background/Objectives To address the underrepresentation of older adults in clinical research, the National Institutes of Health will require investigators to include individuals across the lifespan. As investigators from other fields endeavor to recruit participants who are more representative of the patient population, geriatricians may have the opportunity to influence a broad range of research studies in older adults. Our aims were to elicit challenges to inclusion of older adults in clinical research and to develop a preliminary framework for communicating these challenges to non–geriatrics‐trained researchers. Design Communication framework development. Setting Academic hospital and Veterans Affairs Medical Center. Participants Nongeriatrician researchers and staff, aging research experts. Measurements Interviews were used to elicit challenges nongeriatrician investigators and research staff experience when conducting research that includes older adults and then solicit experienced aging researchers' responses to these challenges. Results Challenges described by nongeriatrician investigators included lack of knowledge, rigid study structures, and a disease‐focused approach. Responses from our geriatrics experts included communicating practical advice for avoiding common pitfalls. Our resulting framework is the 5Ts: Target Population, Team, Tools, Time, and Tips to Accommodate. This tool complements the 5Ms (Mind, Mobility, Medications, Multicomplexity, and Matters Most to Me) model for geriatric care and emphasizes representation of the Target Population, building research Teams that include aging expertise, incorporating appropriate Tools for function and patient‐reported outcomes, anticipating Time for longer study visits, and accommodating common needs with practical Tips. Limitations include convenience sampling and lack of formal qualitative thematic analysis. Conclusion Communicating with nongeriatrician researchers using the 5Ts may offer a practical approach to avoiding barriers to inclusion of older adults in research and complements an existing framework for communicating the value of geriatric medicine. Next steps in developing the 5Ts will be to include additional stakeholders (eg, national samples of nongeriatrician investigators, older adults and their families) and evaluating the impact of its implementation. J Am Geriatr Soc 67:342–346, 2019.

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A systematic review of trends in the selective exclusion of older participant from randomised clinical trials

Cited by 48 publications

References 13 publications

Exclusion rates in randomized controlled trials of treatments for physical conditions: a systematic review

Exclusion rates in randomized controlled trials of treatments for physical conditions: a systematic review

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

The 5Ts: Preliminary Development of a Framework to Support Inclusion of Older Adults in Research

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