Prevalence and Characteristics of Interventional Trials Conducted Exclusively in Elderly Persons: A Cross-Sectional Analysis of Registered Clinical Trials
Elderly patients represent the greatest consumers of healthcare per capita but have historically been underrepresented in clinical trials. It is unknown how many trials are designed to focus exclusively on elderly patients. To define the prevalence of interventional trials that study exclusively eld...
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| creator | Bourgeois, Florence T Olson, Karen L Tse, Tony Ioannidis, John P A Mandl, Kenneth D |
| description | Elderly patients represent the greatest consumers of healthcare per capita but have historically been underrepresented in clinical trials. It is unknown how many trials are designed to focus exclusively on elderly patients.
To define the prevalence of interventional trials that study exclusively elderly persons and describe the characteristics of these trials, including their distribution across conditions most prevalent in the elderly.
All interventional clinical trials enrolling exclusively elderly patients (≥65 years), conducted primarily in high-income countries, and initiated between 2006 and 2014, identified through ClincialTrials.gov.
Trials were identified and characterized according to design features and disease categories studied. Across disease categories we examined the burden of disease in the elderly in high-income countries (measured in disability-adjusted life years [DALYs]) and compared to the number of trials conducted exclusively in the elderly.
Among 80,965 interventional trials, 1,112 (1.4%) focused on elderly patients. Diverse types of interventions were studied in these trials (medications 33%, behavioral interventions 18%, and dietary supplements 10%) and the majority was funded by non-profit organizations (81%). Studies tended to be small (median sample size 122 participants [IQR 58, 305]), single-center studies (67%). Only 43% of 126 disease categories affecting elderly persons were studied in trials focused on the elderly. Among these disease categories, there was a 5162-fold range in the ratio of DALYs per trial. Across 5 conditions where over 80% of DALYs are in the elderly, there were a total of only 117 trials done exclusively in the elderly.
Very few and mostly small studies are conducted exclusively in elderly persons, even for conditions that affect almost exclusively the elderly. |
| doi_str_mv | 10.1371/journal.pone.0155948 |
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To define the prevalence of interventional trials that study exclusively elderly persons and describe the characteristics of these trials, including their distribution across conditions most prevalent in the elderly.
All interventional clinical trials enrolling exclusively elderly patients (≥65 years), conducted primarily in high-income countries, and initiated between 2006 and 2014, identified through ClincialTrials.gov.
Trials were identified and characterized according to design features and disease categories studied. Across disease categories we examined the burden of disease in the elderly in high-income countries (measured in disability-adjusted life years [DALYs]) and compared to the number of trials conducted exclusively in the elderly.
Among 80,965 interventional trials, 1,112 (1.4%) focused on elderly patients. Diverse types of interventions were studied in these trials (medications 33%, behavioral interventions 18%, and dietary supplements 10%) and the majority was funded by non-profit organizations (81%). Studies tended to be small (median sample size 122 participants [IQR 58, 305]), single-center studies (67%). Only 43% of 126 disease categories affecting elderly persons were studied in trials focused on the elderly. Among these disease categories, there was a 5162-fold range in the ratio of DALYs per trial. Across 5 conditions where over 80% of DALYs are in the elderly, there were a total of only 117 trials done exclusively in the elderly.
Very few and mostly small studies are conducted exclusively in elderly persons, even for conditions that affect almost exclusively the elderly.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0155948</identifier><identifier>PMID: 27196289</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Age ; Age Factors ; Aged ; Arthritis ; Bias ; Care and treatment ; Categories ; Clinical trials ; Clinical Trials as Topic - standards ; Clinical Trials as Topic - statistics & numerical data ; Collaboration ; Comorbidity ; Cross-sectional studies ; Diet ; Dietary supplements ; Disease ; Drug therapy ; Elderly patients ; Female ; Geriatrics ; Health care ; Health informatics ; Health risk assessment ; Heart failure ; High income ; Historical account ; Hospitals ; Humans ; Income ; Injuries ; Male ; Medical research ; Medical schools ; Medicine ; Medicine and Health Sciences ; Mortality ; National libraries ; Nonprofit organizations ; Older people ; Patient Selection ; Patients ; Pediatrics ; People and Places ; Prescription drugs ; Prevalence ; Prevalence studies (Epidemiology) ; Registration ; Research and Analysis Methods ; Studies</subject><ispartof>PloS one, 2016-05, Vol.11 (5), p.e0155948-e0155948</ispartof><rights>COPYRIGHT 2016 Public Library of Science</rights><rights>This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication: https://creativecommons.org/publicdomain/zero/1.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-43b41a82bb4ed32053c6f4ef3e7072c550b0f725210cb753a04acdf6584b381c3</citedby><cites>FETCH-LOGICAL-c692t-43b41a82bb4ed32053c6f4ef3e7072c550b0f725210cb753a04acdf6584b381c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4873036/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4873036/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79342,79343</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27196289$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bourgeois, Florence T</creatorcontrib><creatorcontrib>Olson, Karen L</creatorcontrib><creatorcontrib>Tse, Tony</creatorcontrib><creatorcontrib>Ioannidis, John P A</creatorcontrib><creatorcontrib>Mandl, Kenneth D</creatorcontrib><title>Prevalence and Characteristics of Interventional Trials Conducted Exclusively in Elderly Persons: A Cross-Sectional Analysis of Registered Clinical Trials</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Elderly patients represent the greatest consumers of healthcare per capita but have historically been underrepresented in clinical trials. It is unknown how many trials are designed to focus exclusively on elderly patients.
To define the prevalence of interventional trials that study exclusively elderly persons and describe the characteristics of these trials, including their distribution across conditions most prevalent in the elderly.
All interventional clinical trials enrolling exclusively elderly patients (≥65 years), conducted primarily in high-income countries, and initiated between 2006 and 2014, identified through ClincialTrials.gov.
Trials were identified and characterized according to design features and disease categories studied. Across disease categories we examined the burden of disease in the elderly in high-income countries (measured in disability-adjusted life years [DALYs]) and compared to the number of trials conducted exclusively in the elderly.
Among 80,965 interventional trials, 1,112 (1.4%) focused on elderly patients. Diverse types of interventions were studied in these trials (medications 33%, behavioral interventions 18%, and dietary supplements 10%) and the majority was funded by non-profit organizations (81%). Studies tended to be small (median sample size 122 participants [IQR 58, 305]), single-center studies (67%). Only 43% of 126 disease categories affecting elderly persons were studied in trials focused on the elderly. Among these disease categories, there was a 5162-fold range in the ratio of DALYs per trial. Across 5 conditions where over 80% of DALYs are in the elderly, there were a total of only 117 trials done exclusively in the elderly.
Very few and mostly small studies are conducted exclusively in elderly persons, even for conditions that affect almost exclusively the elderly.</description><subject>Age</subject><subject>Age Factors</subject><subject>Aged</subject><subject>Arthritis</subject><subject>Bias</subject><subject>Care and treatment</subject><subject>Categories</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic - standards</subject><subject>Clinical Trials as Topic - statistics & numerical data</subject><subject>Collaboration</subject><subject>Comorbidity</subject><subject>Cross-sectional studies</subject><subject>Diet</subject><subject>Dietary supplements</subject><subject>Disease</subject><subject>Drug therapy</subject><subject>Elderly patients</subject><subject>Female</subject><subject>Geriatrics</subject><subject>Health care</subject><subject>Health informatics</subject><subject>Health risk assessment</subject><subject>Heart failure</subject><subject>High 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Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bourgeois, Florence T</au><au>Olson, Karen L</au><au>Tse, Tony</au><au>Ioannidis, John P A</au><au>Mandl, Kenneth D</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prevalence and Characteristics of Interventional Trials Conducted Exclusively in Elderly Persons: A Cross-Sectional Analysis of Registered Clinical Trials</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2016-05-19</date><risdate>2016</risdate><volume>11</volume><issue>5</issue><spage>e0155948</spage><epage>e0155948</epage><pages>e0155948-e0155948</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Elderly patients represent the greatest consumers of healthcare per capita but have historically been underrepresented in clinical trials. It is unknown how many trials are designed to focus exclusively on elderly patients.
To define the prevalence of interventional trials that study exclusively elderly persons and describe the characteristics of these trials, including their distribution across conditions most prevalent in the elderly.
All interventional clinical trials enrolling exclusively elderly patients (≥65 years), conducted primarily in high-income countries, and initiated between 2006 and 2014, identified through ClincialTrials.gov.
Trials were identified and characterized according to design features and disease categories studied. Across disease categories we examined the burden of disease in the elderly in high-income countries (measured in disability-adjusted life years [DALYs]) and compared to the number of trials conducted exclusively in the elderly.
Among 80,965 interventional trials, 1,112 (1.4%) focused on elderly patients. Diverse types of interventions were studied in these trials (medications 33%, behavioral interventions 18%, and dietary supplements 10%) and the majority was funded by non-profit organizations (81%). Studies tended to be small (median sample size 122 participants [IQR 58, 305]), single-center studies (67%). Only 43% of 126 disease categories affecting elderly persons were studied in trials focused on the elderly. Among these disease categories, there was a 5162-fold range in the ratio of DALYs per trial. Across 5 conditions where over 80% of DALYs are in the elderly, there were a total of only 117 trials done exclusively in the elderly.
Very few and mostly small studies are conducted exclusively in elderly persons, even for conditions that affect almost exclusively the elderly.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>27196289</pmid><doi>10.1371/journal.pone.0155948</doi><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry; Public Library of Science (PLoS) |
| subjects | Age Age Factors Aged Arthritis Bias Care and treatment Categories Clinical trials Clinical Trials as Topic - standards Clinical Trials as Topic - statistics & numerical data Collaboration Comorbidity Cross-sectional studies Diet Dietary supplements Disease Drug therapy Elderly patients Female Geriatrics Health care Health informatics Health risk assessment Heart failure High income Historical account Hospitals Humans Income Injuries Male Medical research Medical schools Medicine Medicine and Health Sciences Mortality National libraries Nonprofit organizations Older people Patient Selection Patients Pediatrics People and Places Prescription drugs Prevalence Prevalence studies (Epidemiology) Registration Research and Analysis Methods Studies |
| title | Prevalence and Characteristics of Interventional Trials Conducted Exclusively in Elderly Persons: A Cross-Sectional Analysis of Registered Clinical Trials |
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