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Exploring the conduct and reporting of qualitative research in trials using mixed methods / CLARE CLEMENT

Swansea University Author: CLARE CLEMENT

DOI (Published version): 10.23889/SUthesis.62588

Abstract

Background The benefits of using qualitative research in trials (QRT) have been demonstrated and it is commonly used. However, the prevalence of QRT and issues with its conduct have been highlighted. Underpinned by a pragmatic approach, this study aimed to explore the use of QRT and identify factors...

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Published: Swansea 2023
Institution: Swansea University
Degree level: Master of Philosophy
Degree name: M.Phil
Supervisor: Hutchings, Hayley A. ; Edwards, Suzanne L.
URI: https://cronfa.swan.ac.uk/Record/cronfa62588
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fullrecord <?xml version="1.0"?><rfc1807><datestamp>2023-02-06T17:02:35.9521134</datestamp><bib-version>v2</bib-version><id>62588</id><entry>2023-02-06</entry><title>Exploring the conduct and reporting of qualitative research in trials using mixed methods</title><swanseaauthors><author><sid>185003696ba40b6ad51249466690d56c</sid><firstname>CLARE</firstname><surname>CLEMENT</surname><name>CLARE CLEMENT</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2023-02-06</date><abstract>Background The benefits of using qualitative research in trials (QRT) have been demonstrated and it is commonly used. However, the prevalence of QRT and issues with its conduct have been highlighted. Underpinned by a pragmatic approach, this study aimed to explore the use of QRT and identify factors that influence its implementation and reporting. Methods A convergent mixed methods design which included five components 1) a systematic review of 1,492 registered trials that report using qualitative research (1999-2016), 2) a critical review of 2,343 publications reporting QRT (2011-2017), 3) a narrative synthesis which involved the thematic analysis of 23 publications (2011-2020), 4) a case study of three trials which used qualitative research. The case study included nine interviews with members of the case study trial teams as well as 149 trial documents, and 5) the development and piloting of two quality appraisal checklists for QRT reporting. Findings The use of QRT has increased over time, but overall usage remains low. Use is limited to trials investigating behavioural interventions, those conducted in rich Western countries and in trials in co-morbidity conditions, oncology, and mental health. Overall reporting quality for QRT appears to be good but is variable with some areas of reporting being poorer. Engagement with QRT depends on people understanding it and seeing its value. Embedding qualitative researchers within the trial team, good collaborative relationships, consideration of the needs of all trial components and how these relate to each other and being flexible can help to overcome methodological tensions and ensure successful QRT. Conclusion Researchers and other stakeholders involved in trials need to recognise the benefits that QRT can bring and consider its use in a wide range of health areas, countries and in trials evaluating all forms of interventions. Further recommendations for the planning, conduct and reporting QRT are provided.</abstract><type>E-Thesis</type><journal/><volume/><journalNumber/><paginationStart/><paginationEnd/><publisher/><placeOfPublication>Swansea</placeOfPublication><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic/><keywords>Qualitative research, Randomised controlled trial, Research design, Research support humans, mixed methods</keywords><publishedDay>12</publishedDay><publishedMonth>1</publishedMonth><publishedYear>2023</publishedYear><publishedDate>2023-01-12</publishedDate><doi>10.23889/SUthesis.62588</doi><url/><notes/><college>COLLEGE NANME</college><CollegeCode>COLLEGE CODE</CollegeCode><institution>Swansea University</institution><supervisor>Hutchings, Hayley A. ; Edwards, Suzanne L.</supervisor><degreelevel>Master of Philosophy</degreelevel><degreename>M.Phil</degreename><apcterm/><funders/><projectreference/><lastEdited>2023-02-06T17:02:35.9521134</lastEdited><Created>2023-02-06T16:45:57.6787386</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>CLARE</firstname><surname>CLEMENT</surname><order>1</order></author></authors><documents><document><filename>62588__26491__33eeb960fb574a0cb0e3e91794562b58.pdf</filename><originalFilename>Clement_Clare_MPhil_Thesis_Final_Redacted_Signature.pdf</originalFilename><uploaded>2023-02-06T16:55:22.4692784</uploaded><type>Output</type><contentLength>5909480</contentLength><contentType>application/pdf</contentType><version>E-Thesis &#x2013; open access</version><cronfaStatus>true</cronfaStatus><documentNotes>Copyright: The author, Clare Clement, 2023.</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language></document></documents><OutputDurs/></rfc1807>
spelling 2023-02-06T17:02:35.9521134 v2 62588 2023-02-06 Exploring the conduct and reporting of qualitative research in trials using mixed methods 185003696ba40b6ad51249466690d56c CLARE CLEMENT CLARE CLEMENT true false 2023-02-06 Background The benefits of using qualitative research in trials (QRT) have been demonstrated and it is commonly used. However, the prevalence of QRT and issues with its conduct have been highlighted. Underpinned by a pragmatic approach, this study aimed to explore the use of QRT and identify factors that influence its implementation and reporting. Methods A convergent mixed methods design which included five components 1) a systematic review of 1,492 registered trials that report using qualitative research (1999-2016), 2) a critical review of 2,343 publications reporting QRT (2011-2017), 3) a narrative synthesis which involved the thematic analysis of 23 publications (2011-2020), 4) a case study of three trials which used qualitative research. The case study included nine interviews with members of the case study trial teams as well as 149 trial documents, and 5) the development and piloting of two quality appraisal checklists for QRT reporting. Findings The use of QRT has increased over time, but overall usage remains low. Use is limited to trials investigating behavioural interventions, those conducted in rich Western countries and in trials in co-morbidity conditions, oncology, and mental health. Overall reporting quality for QRT appears to be good but is variable with some areas of reporting being poorer. Engagement with QRT depends on people understanding it and seeing its value. Embedding qualitative researchers within the trial team, good collaborative relationships, consideration of the needs of all trial components and how these relate to each other and being flexible can help to overcome methodological tensions and ensure successful QRT. Conclusion Researchers and other stakeholders involved in trials need to recognise the benefits that QRT can bring and consider its use in a wide range of health areas, countries and in trials evaluating all forms of interventions. Further recommendations for the planning, conduct and reporting QRT are provided. E-Thesis Swansea Qualitative research, Randomised controlled trial, Research design, Research support humans, mixed methods 12 1 2023 2023-01-12 10.23889/SUthesis.62588 COLLEGE NANME COLLEGE CODE Swansea University Hutchings, Hayley A. ; Edwards, Suzanne L. Master of Philosophy M.Phil 2023-02-06T17:02:35.9521134 2023-02-06T16:45:57.6787386 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine CLARE CLEMENT 1 62588__26491__33eeb960fb574a0cb0e3e91794562b58.pdf Clement_Clare_MPhil_Thesis_Final_Redacted_Signature.pdf 2023-02-06T16:55:22.4692784 Output 5909480 application/pdf E-Thesis – open access true Copyright: The author, Clare Clement, 2023. true eng
title Exploring the conduct and reporting of qualitative research in trials using mixed methods
spellingShingle Exploring the conduct and reporting of qualitative research in trials using mixed methods
CLARE CLEMENT
title_short Exploring the conduct and reporting of qualitative research in trials using mixed methods
title_full Exploring the conduct and reporting of qualitative research in trials using mixed methods
title_fullStr Exploring the conduct and reporting of qualitative research in trials using mixed methods
title_full_unstemmed Exploring the conduct and reporting of qualitative research in trials using mixed methods
title_sort Exploring the conduct and reporting of qualitative research in trials using mixed methods
author_id_str_mv 185003696ba40b6ad51249466690d56c
author_id_fullname_str_mv 185003696ba40b6ad51249466690d56c_***_CLARE CLEMENT
author CLARE CLEMENT
author2 CLARE CLEMENT
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publishDate 2023
institution Swansea University
doi_str_mv 10.23889/SUthesis.62588
college_str Faculty of Medicine, Health and Life Sciences
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hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
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description Background The benefits of using qualitative research in trials (QRT) have been demonstrated and it is commonly used. However, the prevalence of QRT and issues with its conduct have been highlighted. Underpinned by a pragmatic approach, this study aimed to explore the use of QRT and identify factors that influence its implementation and reporting. Methods A convergent mixed methods design which included five components 1) a systematic review of 1,492 registered trials that report using qualitative research (1999-2016), 2) a critical review of 2,343 publications reporting QRT (2011-2017), 3) a narrative synthesis which involved the thematic analysis of 23 publications (2011-2020), 4) a case study of three trials which used qualitative research. The case study included nine interviews with members of the case study trial teams as well as 149 trial documents, and 5) the development and piloting of two quality appraisal checklists for QRT reporting. Findings The use of QRT has increased over time, but overall usage remains low. Use is limited to trials investigating behavioural interventions, those conducted in rich Western countries and in trials in co-morbidity conditions, oncology, and mental health. Overall reporting quality for QRT appears to be good but is variable with some areas of reporting being poorer. Engagement with QRT depends on people understanding it and seeing its value. Embedding qualitative researchers within the trial team, good collaborative relationships, consideration of the needs of all trial components and how these relate to each other and being flexible can help to overcome methodological tensions and ensure successful QRT. Conclusion Researchers and other stakeholders involved in trials need to recognise the benefits that QRT can bring and consider its use in a wide range of health areas, countries and in trials evaluating all forms of interventions. Further recommendations for the planning, conduct and reporting QRT are provided.
published_date 2023-01-12T04:22:19Z
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score 11.013148

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