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Maximising recruitment to a randomised controlled trial for chronic rhinosinusitis using qualitative research methods: the MACRO conversation study

Maximising recruitment to a randomised controlled trial for chronic rhinosinusitis using qualitative research methods: the MACRO conversation study
Maximising recruitment to a randomised controlled trial for chronic rhinosinusitis using qualitative research methods: the MACRO conversation study

Background: Randomised controlled trials (RCTs) are considered the ‘gold standard’ of medical evidence; however, recruitment can be challenging. The MACRO trial is a NIHR-funded RCT for chronic rhinosinusitis (CRS) addressing the challenge of comparing surgery, antibiotics and placebo. The embedded MACRO conversation study (MCS) used qualitative research techniques pioneered by the University of Bristol QuinteT team to explore recruitment issues during the pilot phase, to maximise recruitment in the main trial. 

Methods: Setting: Five outpatient Ear Nose and Throat (ENT) departments recruiting for the pilot phase of the MACRO trial (ISRCTN Number: 36962030, prospectively registered 17 October 2018). We conducted a thematic analysis of telephone interviews with 18 recruiters and 19 patients and 61 audio-recordings of recruitment conversations. We reviewed screening and recruitment data and mapped patient pathways at participating sites. We presented preliminary findings to individual site teams. Group discussions enabled further exploration of issues, evolving strategies and potential solutions. Findings were reported back to the funder and used together with recruitment data to justify progression to the main trial. 

Results: Recruitment in the MACRO pilot trial began slowly but accelerated in time to progress successfully to the main trial. Research nurse involvement was pivotal to successful recruitment. Engaging the wider network of clinical colleagues emerged as an important factor, ensuring the patient pathway through primary and secondary care did not inadvertently affect trial eligibility. The most common reason for patients declining participation was treatment preference. Good patient-clinician relationships engendered trust and supported patient decision-making. Overall, trial involvement appeared clearly presented by recruiters, possibly influenced by pre-trial training. The weakest area of understanding for patients appeared to be trial medications. A clear presentation of medical and surgical treatment options, together with checking patient understanding, had the potential to allay patient concerns. 


Conclusion: The MACRO conversation study contributed to the learning process of optimising recruitment by helping to identify and address recruitment issues. Although some issues were trial-specific, others have applicability to many clinical trial situations. Using qualitative research techniques to identify/explore barriers and facilitators to recruitment may be valuable during the pilot phase of many RCTs including those with complex designs.

Chronic rhinosinusitis, Qualitative research, Randomised controlled trial, Recruitment, Thematic analysis
1745-6215
Mcdermott, Clare
731edcc4-daf0-432d-98aa-45052beae320
Vennik, Jane
6ee78166-5a7a-433b-87fc-018771f20b19
Philpott, Carl
3b9f988c-a61e-4736-9b69-6697fb2cdc5b
Le Conte, Steffi
5753e4c4-8fa2-4e3a-af6d-e277e5e8350c
Thomas, Mike
997c78e0-3849-4ce8-b1bc-86ebbdee3953
Eyles, Caroline
d6cfad74-e004-49df-8aae-df3dea620b7d
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Blackshaw, Helen
89f97306-9bba-42b3-a09f-4574d08bd711
Schilder, Anne G.M.
4efe172e-cbc9-4d1b-b089-f293f5c626ef
Hopkins, Claire
8ed0a5e3-92a3-4988-9c2b-b0e51a8a044c
Mcdermott, Clare
731edcc4-daf0-432d-98aa-45052beae320
Vennik, Jane
6ee78166-5a7a-433b-87fc-018771f20b19
Philpott, Carl
3b9f988c-a61e-4736-9b69-6697fb2cdc5b
Le Conte, Steffi
5753e4c4-8fa2-4e3a-af6d-e277e5e8350c
Thomas, Mike
997c78e0-3849-4ce8-b1bc-86ebbdee3953
Eyles, Caroline
d6cfad74-e004-49df-8aae-df3dea620b7d
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Blackshaw, Helen
89f97306-9bba-42b3-a09f-4574d08bd711
Schilder, Anne G.M.
4efe172e-cbc9-4d1b-b089-f293f5c626ef
Hopkins, Claire
8ed0a5e3-92a3-4988-9c2b-b0e51a8a044c

Mcdermott, Clare, Vennik, Jane, Philpott, Carl, Le Conte, Steffi, Thomas, Mike, Eyles, Caroline, Little, Paul, Blackshaw, Helen, Schilder, Anne G.M. and Hopkins, Claire (2021) Maximising recruitment to a randomised controlled trial for chronic rhinosinusitis using qualitative research methods: the MACRO conversation study. Trials, 22 (1), [54]. (doi:10.1186/s13063-020-04993-w).

Record type: Article

Abstract

Background: Randomised controlled trials (RCTs) are considered the ‘gold standard’ of medical evidence; however, recruitment can be challenging. The MACRO trial is a NIHR-funded RCT for chronic rhinosinusitis (CRS) addressing the challenge of comparing surgery, antibiotics and placebo. The embedded MACRO conversation study (MCS) used qualitative research techniques pioneered by the University of Bristol QuinteT team to explore recruitment issues during the pilot phase, to maximise recruitment in the main trial. 

Methods: Setting: Five outpatient Ear Nose and Throat (ENT) departments recruiting for the pilot phase of the MACRO trial (ISRCTN Number: 36962030, prospectively registered 17 October 2018). We conducted a thematic analysis of telephone interviews with 18 recruiters and 19 patients and 61 audio-recordings of recruitment conversations. We reviewed screening and recruitment data and mapped patient pathways at participating sites. We presented preliminary findings to individual site teams. Group discussions enabled further exploration of issues, evolving strategies and potential solutions. Findings were reported back to the funder and used together with recruitment data to justify progression to the main trial. 

Results: Recruitment in the MACRO pilot trial began slowly but accelerated in time to progress successfully to the main trial. Research nurse involvement was pivotal to successful recruitment. Engaging the wider network of clinical colleagues emerged as an important factor, ensuring the patient pathway through primary and secondary care did not inadvertently affect trial eligibility. The most common reason for patients declining participation was treatment preference. Good patient-clinician relationships engendered trust and supported patient decision-making. Overall, trial involvement appeared clearly presented by recruiters, possibly influenced by pre-trial training. The weakest area of understanding for patients appeared to be trial medications. A clear presentation of medical and surgical treatment options, together with checking patient understanding, had the potential to allay patient concerns. 


Conclusion: The MACRO conversation study contributed to the learning process of optimising recruitment by helping to identify and address recruitment issues. Although some issues were trial-specific, others have applicability to many clinical trial situations. Using qualitative research techniques to identify/explore barriers and facilitators to recruitment may be valuable during the pilot phase of many RCTs including those with complex designs.

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More information

Accepted/In Press date: 22 December 2020
Published date: 13 January 2021
Keywords: Chronic rhinosinusitis, Qualitative research, Randomised controlled trial, Recruitment, Thematic analysis

Identifiers

Local EPrints ID: 447470
URI: http://eprints.soton.ac.uk/id/eprint/447470
ISSN: 1745-6215
PURE UUID: 629a7ee2-02cb-43aa-be76-ac8b458d9047
ORCID for Clare Mcdermott: ORCID iD orcid.org/0000-0001-7389-2116
ORCID for Jane Vennik: ORCID iD orcid.org/0000-0003-4602-9805

Catalogue record

Date deposited: 12 Mar 2021 17:30
Last modified: 10 Jan 2022 03:10

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Contributors

Author: Clare Mcdermott ORCID iD
Author: Jane Vennik ORCID iD
Author: Carl Philpott
Author: Steffi Le Conte
Author: Mike Thomas
Author: Caroline Eyles
Author: Paul Little
Author: Helen Blackshaw
Author: Anne G.M. Schilder
Author: Claire Hopkins

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