Factors that influence women’s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial
Abstract Background The use of decentralised clinical trials (which bring trials to patients through remote processes and technology versus central on-site visits) has been thought to be a potential solution to common recruitment and retention barriers. However, there is a lack of evidence to unders...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07630-4 |
| _version_ | 1797451652494524416 |
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| author | Cherish Boxall Susanne Renz Zina Eminton Jacqueline Nuttall Alan Saji Charlotte Cluff Christopher Wilcox Ingrid Muller Alison M. Layton Irene Soulsby Miriam Santer |
| author_facet | Cherish Boxall Susanne Renz Zina Eminton Jacqueline Nuttall Alan Saji Charlotte Cluff Christopher Wilcox Ingrid Muller Alison M. Layton Irene Soulsby Miriam Santer |
| author_sort | Cherish Boxall |
| collection | DOAJ |
| description | Abstract Background The use of decentralised clinical trials (which bring trials to patients through remote processes and technology versus central on-site visits) has been thought to be a potential solution to common recruitment and retention barriers. However, there is a lack of evidence to understand the experiences, needs and preferences of the public to inform trial methodologies that appeal to different populations. We report participant experiences of SAFA, a partially decentralised randomised clinical trial, to inform the methodology used in future dermatology trials that aim to appeal to women aged 18 and over. Methods Participants of the SAFA (Spironolactone for Adult Female Acne) trial were invited to take part in a qualitative semi-structured interview to explore their experience and perspectives of taking part in the trial. Questions focused on their experience of using decentralised methods to access and enrol in the trial (e.g. social media advertising), in addition to the decentralised trial visit and data collection methods used throughout. Interviews were conducted remotely, recorded, and transcribed. Data were analysed using reflexive thematic analysis. Results Twelve SAFA participants (all women, age range 22–36 years) were interviewed. Initially, participants were influenced to enrol by trusted online information, the feeling of validation the trial provided, and the convenience and flexibility offered by the decentralised methods and research staff made participants feel valued and enabled them to engage in the trial with minimal interference to existing commitments. SAFA participants were generally accepting of trial demands, such as the text-heavy paperwork and on-site visits for blood collection and highlighted several areas relevant for trial conduct going forwards including where decentralised methods may (and may not) be accepted and how trial accessibility and understanding could be improved. Conclusions The study has shown that decentralised methods used by responsive and approachable staff were widely accepted in the SAFA trial. Interviewees found the methods adopted in the SAFA trial helped the trial to fit with their needs and promoted a sense of feeling valued that encouraged ongoing trial engagement. Decentralised methods should be considered favourably when designing a dermatology trial as they can potentially enhance both recruitment and retention. Trial registration number ISRCTN 12892056. Registered on October 15, 2018. |
| first_indexed | 2024-03-09T14:56:37Z |
| format | Article |
| id | doaj.art-e5654ea39e4349f08009e6f469d0c5c4 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-09T14:56:37Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-e5654ea39e4349f08009e6f469d0c5c42023-11-26T14:09:38ZengBMCTrials1745-62152023-10-0124111010.1186/s13063-023-07630-4Factors that influence women’s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trialCherish Boxall0Susanne Renz1Zina Eminton2Jacqueline Nuttall3Alan Saji4Charlotte Cluff5Christopher Wilcox6Ingrid Muller7Alison M. Layton8Irene Soulsby9Miriam Santer10Southampton Clinical Trials Unit, University of SouthamptonSouthampton Clinical Trials Unit, University of SouthamptonSouthampton Clinical Trials Unit, University of SouthamptonSouthampton Clinical Trials Unit, University of SouthamptonFaculty of Medicine, University of SouthamptonFaculty of Medicine, University of SouthamptonPrimary Care Research Centre, University of SouthamptonPrimary Care Research Centre, University of SouthamptonSkin Research Centre, University of YorkSouthampton Clinical Trials Unit, University of SouthamptonPrimary Care Research Centre, University of SouthamptonAbstract Background The use of decentralised clinical trials (which bring trials to patients through remote processes and technology versus central on-site visits) has been thought to be a potential solution to common recruitment and retention barriers. However, there is a lack of evidence to understand the experiences, needs and preferences of the public to inform trial methodologies that appeal to different populations. We report participant experiences of SAFA, a partially decentralised randomised clinical trial, to inform the methodology used in future dermatology trials that aim to appeal to women aged 18 and over. Methods Participants of the SAFA (Spironolactone for Adult Female Acne) trial were invited to take part in a qualitative semi-structured interview to explore their experience and perspectives of taking part in the trial. Questions focused on their experience of using decentralised methods to access and enrol in the trial (e.g. social media advertising), in addition to the decentralised trial visit and data collection methods used throughout. Interviews were conducted remotely, recorded, and transcribed. Data were analysed using reflexive thematic analysis. Results Twelve SAFA participants (all women, age range 22–36 years) were interviewed. Initially, participants were influenced to enrol by trusted online information, the feeling of validation the trial provided, and the convenience and flexibility offered by the decentralised methods and research staff made participants feel valued and enabled them to engage in the trial with minimal interference to existing commitments. SAFA participants were generally accepting of trial demands, such as the text-heavy paperwork and on-site visits for blood collection and highlighted several areas relevant for trial conduct going forwards including where decentralised methods may (and may not) be accepted and how trial accessibility and understanding could be improved. Conclusions The study has shown that decentralised methods used by responsive and approachable staff were widely accepted in the SAFA trial. Interviewees found the methods adopted in the SAFA trial helped the trial to fit with their needs and promoted a sense of feeling valued that encouraged ongoing trial engagement. Decentralised methods should be considered favourably when designing a dermatology trial as they can potentially enhance both recruitment and retention. Trial registration number ISRCTN 12892056. Registered on October 15, 2018.https://doi.org/10.1186/s13063-023-07630-4DecentralisedHybridExperienceTrialDermatologyRecruitment |
| spellingShingle | Cherish Boxall Susanne Renz Zina Eminton Jacqueline Nuttall Alan Saji Charlotte Cluff Christopher Wilcox Ingrid Muller Alison M. Layton Irene Soulsby Miriam Santer Factors that influence women’s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial Trials Decentralised Hybrid Experience Trial Dermatology Recruitment |
| title | Factors that influence women’s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial |
| title_full | Factors that influence women’s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial |
| title_fullStr | Factors that influence women’s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial |
| title_full_unstemmed | Factors that influence women’s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial |
| title_short | Factors that influence women’s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial |
| title_sort | factors that influence women s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial a qualitative interview study with participants in the safa spironolactone for adult female acne trial |
| topic | Decentralised Hybrid Experience Trial Dermatology Recruitment |
| url | https://doi.org/10.1186/s13063-023-07630-4 |
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