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Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

Frances Rapport, Mel Storey, Alison Porter Orcid Logo, Helen Snooks Orcid Logo, Kerina Jones, Julie Peconi, Antonio Sánchez, Stefan Siebert, Kym Carter Orcid Logo, Clare Clement, Ian Russell

Trials, Volume: 14, Issue: 1, Start page: 54

Swansea University Authors: Alison Porter Orcid Logo, Helen Snooks Orcid Logo, Julie Peconi, Kym Carter Orcid Logo

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DOI (Published version): 10.1186/1745-6215-14-54

Abstract

BackgroundQualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to...

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Published in: Trials
ISSN: 1745-6215
Published: Springer Science and Business Media LLC 2013
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URI: https://cronfa.swan.ac.uk/Record/cronfa54275
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These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design.MethodsHealth services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP).ResultsThe qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component.ConclusionsWe recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials</abstract><type>Journal Article</type><journal>Trials</journal><volume>14</volume><journalNumber>1</journalNumber><paginationStart>54</paginationStart><paginationEnd/><publisher>Springer Science and Business Media LLC</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>1745-6215</issnPrint><issnElectronic/><keywords>National Health Service; Qualitative Method; Standard Operating Procedure; Chief Investigator; Qualitative Component</keywords><publishedDay>21</publishedDay><publishedMonth>2</publishedMonth><publishedYear>2013</publishedYear><publishedDate>2013-02-21</publishedDate><doi>10.1186/1745-6215-14-54</doi><url/><notes/><college>COLLEGE NANME</college><department>Health Data Science</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HDAT</DepartmentCode><institution>Swansea University</institution><apcterm/><funders/><projectreference/><lastEdited>2022-11-11T15:39:42.2245934</lastEdited><Created>2013-01-01T00:00:00.0000000</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>Frances</firstname><surname>Rapport</surname><order>1</order></author><author><firstname>Mel</firstname><surname>Storey</surname><order>2</order></author><author><firstname>Alison</firstname><surname>Porter</surname><orcid>0000-0002-3408-7007</orcid><order>3</order></author><author><firstname>Helen</firstname><surname>Snooks</surname><orcid>0000-0003-0173-8843</orcid><order>4</order></author><author><firstname>Kerina</firstname><surname>Jones</surname><order>5</order></author><author><firstname>Julie</firstname><surname>Peconi</surname><order>6</order></author><author><firstname>Antonio</firstname><surname>S&#xE1;nchez</surname><order>7</order></author><author><firstname>Stefan</firstname><surname>Siebert</surname><order>8</order></author><author><firstname>Kym</firstname><surname>Carter</surname><orcid>0000-0003-0691-6282</orcid><order>9</order></author><author><firstname>Clare</firstname><surname>Clement</surname><order>10</order></author><author><firstname>Ian</firstname><surname>Russell</surname><order>11</order></author></authors><documents><document><filename>54275__25744__247209d411dd40a29d160e3517db9d4f.pdf</filename><originalFilename>54275.pdf</originalFilename><uploaded>2022-11-11T15:38:57.2041160</uploaded><type>Output</type><contentLength>407102</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>&#xA9; 2013 Rapport et al.; This is an Open Access article distributed under the terms of the Creative Commons Attribution License</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>http://creativecommons.org/licenses/by/2.0</licence></document></documents><OutputDurs/></rfc1807>
spelling 2022-11-11T15:39:42.2245934 v2 54275 2013-01-01 Qualitative research within trials: developing a standard operating procedure for a clinical trials unit fcc861ec479a79f7fb9befb13192238b 0000-0002-3408-7007 Alison Porter Alison Porter true false ab23c5e0111b88427a155a1f495861d9 0000-0003-0173-8843 Helen Snooks Helen Snooks true false 55cdaf988e981df96182ece79762a3cf Julie Peconi Julie Peconi true false 1b1870c5c1ec66eed0bf209e50a6ee25 0000-0003-0691-6282 Kym Carter Kym Carter true false 2013-01-01 HDAT BackgroundQualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design.MethodsHealth services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP).ResultsThe qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component.ConclusionsWe recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials Journal Article Trials 14 1 54 Springer Science and Business Media LLC 1745-6215 National Health Service; Qualitative Method; Standard Operating Procedure; Chief Investigator; Qualitative Component 21 2 2013 2013-02-21 10.1186/1745-6215-14-54 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University 2022-11-11T15:39:42.2245934 2013-01-01T00:00:00.0000000 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Frances Rapport 1 Mel Storey 2 Alison Porter 0000-0002-3408-7007 3 Helen Snooks 0000-0003-0173-8843 4 Kerina Jones 5 Julie Peconi 6 Antonio Sánchez 7 Stefan Siebert 8 Kym Carter 0000-0003-0691-6282 9 Clare Clement 10 Ian Russell 11 54275__25744__247209d411dd40a29d160e3517db9d4f.pdf 54275.pdf 2022-11-11T15:38:57.2041160 Output 407102 application/pdf Version of Record true © 2013 Rapport et al.; This is an Open Access article distributed under the terms of the Creative Commons Attribution License true eng http://creativecommons.org/licenses/by/2.0
title Qualitative research within trials: developing a standard operating procedure for a clinical trials unit
spellingShingle Qualitative research within trials: developing a standard operating procedure for a clinical trials unit
Alison Porter
Helen Snooks
Julie Peconi
Kym Carter
title_short Qualitative research within trials: developing a standard operating procedure for a clinical trials unit
title_full Qualitative research within trials: developing a standard operating procedure for a clinical trials unit
title_fullStr Qualitative research within trials: developing a standard operating procedure for a clinical trials unit
title_full_unstemmed Qualitative research within trials: developing a standard operating procedure for a clinical trials unit
title_sort Qualitative research within trials: developing a standard operating procedure for a clinical trials unit
author_id_str_mv fcc861ec479a79f7fb9befb13192238b
ab23c5e0111b88427a155a1f495861d9
55cdaf988e981df96182ece79762a3cf
1b1870c5c1ec66eed0bf209e50a6ee25
author_id_fullname_str_mv fcc861ec479a79f7fb9befb13192238b_***_Alison Porter
ab23c5e0111b88427a155a1f495861d9_***_Helen Snooks
55cdaf988e981df96182ece79762a3cf_***_Julie Peconi
1b1870c5c1ec66eed0bf209e50a6ee25_***_Kym Carter
author Alison Porter
Helen Snooks
Julie Peconi
Kym Carter
author2 Frances Rapport
Mel Storey
Alison Porter
Helen Snooks
Kerina Jones
Julie Peconi
Antonio Sánchez
Stefan Siebert
Kym Carter
Clare Clement
Ian Russell
format Journal article
container_title Trials
container_volume 14
container_issue 1
container_start_page 54
publishDate 2013
institution Swansea University
issn 1745-6215
doi_str_mv 10.1186/1745-6215-14-54
publisher Springer Science and Business Media LLC
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
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
active_str 0
description BackgroundQualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design.MethodsHealth services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP).ResultsThe qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component.ConclusionsWe recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials
published_date 2013-02-21T04:07:42Z
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