Recruitment and Retention of Pregnant Women Into Clinical Research Trials: An Overview of Challenges, Facilitators, and Best Practices
Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facil...
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Veröffentlicht in: | Clinical infectious diseases 2014-12, Vol.59 (suppl 7), p.S400-S407 |
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creator | Frew, Paula M. Saint-Victor, Diane S. Isaacs, Margaret Brewinski Kim, Sonnie Swamy, Geeta K. Sheffield, Jeanne S. Edwards, Kathryn M. Villafana, Tonya Kamagate, Ouda Ault, Kevin |
description | Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies. |
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Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1093/cid/ciu726</identifier><identifier>PMID: 25425718</identifier><language>eng</language><publisher>United States: Oxford University Press</publisher><subject>Adult ; Biomedical Research ; Clinical research ; Clinical trials ; Clinical Trials as Topic ; Female ; Group facilitation ; Humans ; Including Pregnant Women in Clinical Trials of Antimicrobials and Vaccines ; Influenza vaccines ; Medical research ; Patient Selection ; Pregnancy ; Pregnant Women ; Prenatal care ; Recruitment ; Research methods ; Research studies ; Retention ; Women ; Womens health</subject><ispartof>Clinical infectious diseases, 2014-12, Vol.59 (suppl 7), p.S400-S407</ispartof><rights>The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.</rights><rights>Copyright Oxford University Press, UK Dec 15, 2014</rights><rights>The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: . 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c428t-6b6ad8d8635e9e9bfbe6c784801e346a1578f88061ef14f4da54a1c16d4ad08d3</citedby><cites>FETCH-LOGICAL-c428t-6b6ad8d8635e9e9bfbe6c784801e346a1578f88061ef14f4da54a1c16d4ad08d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/26362564$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/26362564$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>230,314,776,780,799,881,27901,27902,57992,58225</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25425718$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Frew, Paula M.</creatorcontrib><creatorcontrib>Saint-Victor, Diane S.</creatorcontrib><creatorcontrib>Isaacs, Margaret Brewinski</creatorcontrib><creatorcontrib>Kim, Sonnie</creatorcontrib><creatorcontrib>Swamy, Geeta K.</creatorcontrib><creatorcontrib>Sheffield, Jeanne S.</creatorcontrib><creatorcontrib>Edwards, Kathryn M.</creatorcontrib><creatorcontrib>Villafana, Tonya</creatorcontrib><creatorcontrib>Kamagate, Ouda</creatorcontrib><creatorcontrib>Ault, Kevin</creatorcontrib><title>Recruitment and Retention of Pregnant Women Into Clinical Research Trials: An Overview of Challenges, Facilitators, and Best Practices</title><title>Clinical infectious diseases</title><addtitle>Clin Infect Dis</addtitle><description>Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies.</description><subject>Adult</subject><subject>Biomedical Research</subject><subject>Clinical research</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic</subject><subject>Female</subject><subject>Group facilitation</subject><subject>Humans</subject><subject>Including Pregnant Women in Clinical Trials of Antimicrobials and Vaccines</subject><subject>Influenza vaccines</subject><subject>Medical research</subject><subject>Patient Selection</subject><subject>Pregnancy</subject><subject>Pregnant Women</subject><subject>Prenatal care</subject><subject>Recruitment</subject><subject>Research methods</subject><subject>Research studies</subject><subject>Retention</subject><subject>Women</subject><subject>Womens health</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkV1rFDEUhoNYbF298V4JeCPS0WTyMRkvhLrYWihUSsXLkM2c2c0ym7TJzIp_wN_tWbbW6kXICefJez5eQl5w9o6zVrz3ocMzNbV-RI64Ek2lVcsfY8yUqaQR5pA8LWXNGOeGqSfksFayVg03R-TXFfg8hXEDcaQudvQKRgxDijT19GuGZXSY-Z4QoOdxTHQ-hBi8G5As4LJf0esc3FA-0JNIL7eQtwF-7D7PV24YIC6hHNNT58MQRjemjK9dnU9QRtR3fgweyjNy0KMGPL-7Z-Tb6efr-Zfq4vLsfH5yUXlZm7HSC-060xktFLTQLvoFaN8YaRgHIbXjqjG9MUxz6LnsZeeUdNxz3UnXMdOJGfm4172ZFhvoPI6a3WBvcti4_NMmF-y_mRhWdpm2VgomcJso8OZOIKfbCWewm1A8DIOLkKZiua6NqhU2hOjr_9B1mnLE8ZASTPJWolkz8nZP-ZxKydDfN8OZ3dlr0V67txfhVw_bv0f_-InAyz2wLrjqv3ktdK20FL8BE6GsyQ</recordid><startdate>20141215</startdate><enddate>20141215</enddate><creator>Frew, Paula M.</creator><creator>Saint-Victor, Diane S.</creator><creator>Isaacs, Margaret Brewinski</creator><creator>Kim, Sonnie</creator><creator>Swamy, Geeta K.</creator><creator>Sheffield, Jeanne S.</creator><creator>Edwards, Kathryn M.</creator><creator>Villafana, Tonya</creator><creator>Kamagate, Ouda</creator><creator>Ault, Kevin</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T2</scope><scope>7T7</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>P64</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20141215</creationdate><title>Recruitment and Retention of Pregnant Women Into Clinical Research Trials: An Overview of Challenges, Facilitators, and Best Practices</title><author>Frew, Paula M. ; Saint-Victor, Diane S. ; Isaacs, Margaret Brewinski ; Kim, Sonnie ; Swamy, Geeta K. ; Sheffield, Jeanne S. ; Edwards, Kathryn M. ; Villafana, Tonya ; Kamagate, Ouda ; Ault, Kevin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c428t-6b6ad8d8635e9e9bfbe6c784801e346a1578f88061ef14f4da54a1c16d4ad08d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Biomedical Research</topic><topic>Clinical research</topic><topic>Clinical trials</topic><topic>Clinical Trials as Topic</topic><topic>Female</topic><topic>Group facilitation</topic><topic>Humans</topic><topic>Including Pregnant Women in Clinical Trials of Antimicrobials and Vaccines</topic><topic>Influenza vaccines</topic><topic>Medical research</topic><topic>Patient Selection</topic><topic>Pregnancy</topic><topic>Pregnant Women</topic><topic>Prenatal care</topic><topic>Recruitment</topic><topic>Research methods</topic><topic>Research studies</topic><topic>Retention</topic><topic>Women</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Frew, Paula M.</creatorcontrib><creatorcontrib>Saint-Victor, Diane S.</creatorcontrib><creatorcontrib>Isaacs, Margaret Brewinski</creatorcontrib><creatorcontrib>Kim, Sonnie</creatorcontrib><creatorcontrib>Swamy, Geeta K.</creatorcontrib><creatorcontrib>Sheffield, Jeanne S.</creatorcontrib><creatorcontrib>Edwards, Kathryn M.</creatorcontrib><creatorcontrib>Villafana, Tonya</creatorcontrib><creatorcontrib>Kamagate, Ouda</creatorcontrib><creatorcontrib>Ault, Kevin</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Frew, Paula M.</au><au>Saint-Victor, Diane S.</au><au>Isaacs, Margaret Brewinski</au><au>Kim, Sonnie</au><au>Swamy, Geeta K.</au><au>Sheffield, Jeanne S.</au><au>Edwards, Kathryn M.</au><au>Villafana, Tonya</au><au>Kamagate, Ouda</au><au>Ault, Kevin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Recruitment and Retention of Pregnant Women Into Clinical Research Trials: An Overview of Challenges, Facilitators, and Best Practices</atitle><jtitle>Clinical infectious diseases</jtitle><addtitle>Clin Infect Dis</addtitle><date>2014-12-15</date><risdate>2014</risdate><volume>59</volume><issue>suppl 7</issue><spage>S400</spage><epage>S407</epage><pages>S400-S407</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><abstract>Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies.</abstract><cop>United States</cop><pub>Oxford University Press</pub><pmid>25425718</pmid><doi>10.1093/cid/ciu726</doi><oa>free_for_read</oa></addata></record> |
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subjects | Adult Biomedical Research Clinical research Clinical trials Clinical Trials as Topic Female Group facilitation Humans Including Pregnant Women in Clinical Trials of Antimicrobials and Vaccines Influenza vaccines Medical research Patient Selection Pregnancy Pregnant Women Prenatal care Recruitment Research methods Research studies Retention Women Womens health |
title | Recruitment and Retention of Pregnant Women Into Clinical Research Trials: An Overview of Challenges, Facilitators, and Best Practices |
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