Factors that influence recruitment to COVID-19 vaccine trials: a qualitative evidence synthesis

Abstract Background The COVID-19 pandemic marked a unique period characterised by an extraordinary global virus spread. The collective effort to halt the transmission of the virus led to various public health initiatives, including a variety of COVID-19 vaccine trials. Many of these trials used adap...

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Main Authors: Linda Biesty, Sarah Sheehan, Pauline Meskell, Maura Dowling, Claire Glenton, Sasha Shepperd, Xin Hui S. Chan, Rebecca Cox, Declan Devane, Andrew Booth, Catherine Houghton
Format: Article
Language:English
Published: BMC 2024-12-01
Series:Trials
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Online Access:https://doi.org/10.1186/s13063-024-08670-0
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author Linda Biesty
Sarah Sheehan
Pauline Meskell
Maura Dowling
Claire Glenton
Sasha Shepperd
Xin Hui S. Chan
Rebecca Cox
Declan Devane
Andrew Booth
Catherine Houghton
author_facet Linda Biesty
Sarah Sheehan
Pauline Meskell
Maura Dowling
Claire Glenton
Sasha Shepperd
Xin Hui S. Chan
Rebecca Cox
Declan Devane
Andrew Booth
Catherine Houghton
author_sort Linda Biesty
collection DOAJ
description Abstract Background The COVID-19 pandemic marked a unique period characterised by an extraordinary global virus spread. The collective effort to halt the transmission of the virus led to various public health initiatives, including a variety of COVID-19 vaccine trials. Many of these trials used adaptive methods to address the pandemic’s challenges, such as the need for rapid recruitment. These adaptive methods allow for modifications to the trial procedures without undermining the trial’s integrity, making the research process more flexible and efficient. However, recruiting participants for vaccine trials remains a considerable challenge. The aim of this qualitative evidence synthesis (QES) is to explore the factors that influence a person’s decision to participate in a COVID-19 vaccine trial. Lessons learned from this could help shape future trials’ design and conduct, particularly those conducted within a pandemic. Methods We conducted a systematic search for qualitative studies and mixed methods studies with a qualitative component in the WHO COVID-19 Research Database, MEDLINE, CINAHL, PsycINFO, Epistemomikos, Online Resource for Research in Clinical Trials (ORCCA), and the Cochrane COVID-19 Study Register. We used the best-fit framework synthesis approach and the Social Ecological Model as an a priori framework. We used the GRADE-CERQual approach to assess our confidence in the review findings. Results Five studies involving 539 participants were included. One of these studies included participants in a COVID-19 vaccine trial. In three of the studies, participants were asked hypothetically about their attitudes. Another study included people who had either not responded to or declined an invitation to participate in a COVID-19 vaccine trial. We developed six themes outlining the factors that influence a person’s decision to participate in a COVID-19 vaccine trial: (1) personal gains, (2) perceived risk, (3) influence of family and community, (4) contributing for others, (5) institutional trust and mistrust, and (6) accessibility of the trial. Conclusion This review sheds light on how people perceive the potential personal, family, and community advantages of trial participation and how these perceptions may be weighed against concerns about vaccine safety. The findings also point toward specific aspects of trial methodology to consider when designing COVID-19 vaccine trials. Graphical Abstract
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spelling doaj-art-e405867d12e7410a816ded5d6c8d8e6f2025-08-20T01:57:12ZengBMCTrials1745-62152024-12-0125112010.1186/s13063-024-08670-0Factors that influence recruitment to COVID-19 vaccine trials: a qualitative evidence synthesisLinda Biesty0Sarah Sheehan1Pauline Meskell2Maura Dowling3Claire Glenton4Sasha Shepperd5Xin Hui S. Chan6Rebecca Cox7Declan Devane8Andrew Booth9Catherine Houghton10School of Nursing and Midwifery, University of GalwaySchool of Nursing and Midwifery, University of GalwayEvidence Synthesis Ireland, University of GalwaySchool of Nursing and Midwifery, University of GalwayWestern Norway University of Applied SciencesNuttfield Department of Population Health, University of OxfordPandemic Sciences Institute, University of OxfordDepartment of Clinical Sciences, University of BergenSchool of Nursing and Midwifery, University of GalwaySchool of Health and Related Research, University of SheffieldSchool of Nursing and Midwifery, University of GalwayAbstract Background The COVID-19 pandemic marked a unique period characterised by an extraordinary global virus spread. The collective effort to halt the transmission of the virus led to various public health initiatives, including a variety of COVID-19 vaccine trials. Many of these trials used adaptive methods to address the pandemic’s challenges, such as the need for rapid recruitment. These adaptive methods allow for modifications to the trial procedures without undermining the trial’s integrity, making the research process more flexible and efficient. However, recruiting participants for vaccine trials remains a considerable challenge. The aim of this qualitative evidence synthesis (QES) is to explore the factors that influence a person’s decision to participate in a COVID-19 vaccine trial. Lessons learned from this could help shape future trials’ design and conduct, particularly those conducted within a pandemic. Methods We conducted a systematic search for qualitative studies and mixed methods studies with a qualitative component in the WHO COVID-19 Research Database, MEDLINE, CINAHL, PsycINFO, Epistemomikos, Online Resource for Research in Clinical Trials (ORCCA), and the Cochrane COVID-19 Study Register. We used the best-fit framework synthesis approach and the Social Ecological Model as an a priori framework. We used the GRADE-CERQual approach to assess our confidence in the review findings. Results Five studies involving 539 participants were included. One of these studies included participants in a COVID-19 vaccine trial. In three of the studies, participants were asked hypothetically about their attitudes. Another study included people who had either not responded to or declined an invitation to participate in a COVID-19 vaccine trial. We developed six themes outlining the factors that influence a person’s decision to participate in a COVID-19 vaccine trial: (1) personal gains, (2) perceived risk, (3) influence of family and community, (4) contributing for others, (5) institutional trust and mistrust, and (6) accessibility of the trial. Conclusion This review sheds light on how people perceive the potential personal, family, and community advantages of trial participation and how these perceptions may be weighed against concerns about vaccine safety. The findings also point toward specific aspects of trial methodology to consider when designing COVID-19 vaccine trials. Graphical Abstracthttps://doi.org/10.1186/s13063-024-08670-0Qualitative evidence synthesisRecruitmentRCTsCOVID-19Vaccination trials
spellingShingle Linda Biesty
Sarah Sheehan
Pauline Meskell
Maura Dowling
Claire Glenton
Sasha Shepperd
Xin Hui S. Chan
Rebecca Cox
Declan Devane
Andrew Booth
Catherine Houghton
Factors that influence recruitment to COVID-19 vaccine trials: a qualitative evidence synthesis
Trials
Qualitative evidence synthesis
Recruitment
RCTs
COVID-19
Vaccination trials
title Factors that influence recruitment to COVID-19 vaccine trials: a qualitative evidence synthesis
title_full Factors that influence recruitment to COVID-19 vaccine trials: a qualitative evidence synthesis
title_fullStr Factors that influence recruitment to COVID-19 vaccine trials: a qualitative evidence synthesis
title_full_unstemmed Factors that influence recruitment to COVID-19 vaccine trials: a qualitative evidence synthesis
title_short Factors that influence recruitment to COVID-19 vaccine trials: a qualitative evidence synthesis
title_sort factors that influence recruitment to covid 19 vaccine trials a qualitative evidence synthesis
topic Qualitative evidence synthesis
Recruitment
RCTs
COVID-19
Vaccination trials
url https://doi.org/10.1186/s13063-024-08670-0
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