Optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan

Abstract Background Addressing the global burden of multidrug-resistant tuberculosis (MDR-TB) requires identification of shorter, less toxic treatment regimens. Médecins Sans Frontières (MSF) is currently conducting a phase II/III randomised controlled clinical trial, to find more effective, shorter...

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Autores principales:	Alexandra Wharton-Smith, Shona Horter, Emma Douch, Nell Gray, Nicola James, Bern-Thomas Nyang’wa, Jatinder Singh, Parpieva Nargiza Nusratovna, Zinaida Tigay, Emil Kazounis, Gulayim Allanazarova, Beverley Stringer
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	MDR-TB Clinical trial Recruitment Qualitative Community engagement Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/e2fede73cd4149599b0eaf002feba403
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spelling	oai:doaj.org-article:e2fede73cd4149599b0eaf002feba4032021-12-05T12:20:06ZOptimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan10.1186/s13063-021-05850-01745-6215https://doaj.org/article/e2fede73cd4149599b0eaf002feba4032021-12-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05850-0https://doaj.org/toc/1745-6215Abstract Background Addressing the global burden of multidrug-resistant tuberculosis (MDR-TB) requires identification of shorter, less toxic treatment regimens. Médecins Sans Frontières (MSF) is currently conducting a phase II/III randomised controlled clinical trial, to find more effective, shorter and tolerable treatments for people with MDR-TB. Recruitment to the trial in Uzbekistan has been slower than expected; we aimed to study patient and health worker experiences of the trial, examining potential factors perceived to impede and facilitate trial recruitment, as well as general perceptions of clinical research in this context. Methods We conducted a qualitative study using maximum variation, purposive sampling of participants. We carried out in-depth interviews (IDIs) and focus group discussions (FGDs) guided by semi-structured topic guides. In December 2019 and January 2020, 26 interviews were conducted with patients, Ministry of Health (MoH) and MSF staff and trial health workers, to explore challenges and barriers to patient recruitment as well as perceptions of the trial and research in general. Preliminary findings from the interviews informed three subsequent focus group discussions held with patients, nurses and counsellors. Focus groups adopted a person-centred design, brainstorming potential solutions to problems and barriers. Interviews and FGDs were audio recorded, translated and transcribed verbatim. Thematic analysis, drawing on constant comparison, was used to analyse the data. Results Health system contexts may compete with new approaches especially when legislative health regulations or policy around treatment is ingrained in staff beliefs, perceptions and practice, which can undermine clinical trial recruitment. Trust plays a significant role in how patients engage with the trial. Decision-making processes are dynamic and associated with relationship to diagnosis, assimilation of information, previous knowledge or experience and influence of peers and close relations. Conclusions This qualitative analysis highlights ways in which insights developed together with patients and healthcare workers might inform approaches towards improved recruitment into trials, with the overall objective of delivering evidence for better treatments.Alexandra Wharton-SmithShona HorterEmma DouchNell GrayNicola JamesBern-Thomas Nyang’waJatinder SinghParpieva Nargiza NusratovnaZinaida TigayEmil KazounisGulayim AllanazarovaBeverley StringerBMCarticleMDR-TBClinical trialRecruitmentQualitativeCommunity engagementMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-14 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	MDR-TB Clinical trial Recruitment Qualitative Community engagement Medicine (General) R5-920
spellingShingle	MDR-TB Clinical trial Recruitment Qualitative Community engagement Medicine (General) R5-920 Alexandra Wharton-Smith Shona Horter Emma Douch Nell Gray Nicola James Bern-Thomas Nyang’wa Jatinder Singh Parpieva Nargiza Nusratovna Zinaida Tigay Emil Kazounis Gulayim Allanazarova Beverley Stringer Optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan
description	Abstract Background Addressing the global burden of multidrug-resistant tuberculosis (MDR-TB) requires identification of shorter, less toxic treatment regimens. Médecins Sans Frontières (MSF) is currently conducting a phase II/III randomised controlled clinical trial, to find more effective, shorter and tolerable treatments for people with MDR-TB. Recruitment to the trial in Uzbekistan has been slower than expected; we aimed to study patient and health worker experiences of the trial, examining potential factors perceived to impede and facilitate trial recruitment, as well as general perceptions of clinical research in this context. Methods We conducted a qualitative study using maximum variation, purposive sampling of participants. We carried out in-depth interviews (IDIs) and focus group discussions (FGDs) guided by semi-structured topic guides. In December 2019 and January 2020, 26 interviews were conducted with patients, Ministry of Health (MoH) and MSF staff and trial health workers, to explore challenges and barriers to patient recruitment as well as perceptions of the trial and research in general. Preliminary findings from the interviews informed three subsequent focus group discussions held with patients, nurses and counsellors. Focus groups adopted a person-centred design, brainstorming potential solutions to problems and barriers. Interviews and FGDs were audio recorded, translated and transcribed verbatim. Thematic analysis, drawing on constant comparison, was used to analyse the data. Results Health system contexts may compete with new approaches especially when legislative health regulations or policy around treatment is ingrained in staff beliefs, perceptions and practice, which can undermine clinical trial recruitment. Trust plays a significant role in how patients engage with the trial. Decision-making processes are dynamic and associated with relationship to diagnosis, assimilation of information, previous knowledge or experience and influence of peers and close relations. Conclusions This qualitative analysis highlights ways in which insights developed together with patients and healthcare workers might inform approaches towards improved recruitment into trials, with the overall objective of delivering evidence for better treatments.
format	article
author	Alexandra Wharton-Smith Shona Horter Emma Douch Nell Gray Nicola James Bern-Thomas Nyang’wa Jatinder Singh Parpieva Nargiza Nusratovna Zinaida Tigay Emil Kazounis Gulayim Allanazarova Beverley Stringer
author_facet	Alexandra Wharton-Smith Shona Horter Emma Douch Nell Gray Nicola James Bern-Thomas Nyang’wa Jatinder Singh Parpieva Nargiza Nusratovna Zinaida Tigay Emil Kazounis Gulayim Allanazarova Beverley Stringer
author_sort	Alexandra Wharton-Smith
title	Optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan
title_short	Optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan
title_full	Optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan
title_fullStr	Optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan
title_full_unstemmed	Optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan
title_sort	optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in uzbekistan
publisher	BMC
publishDate	2021
url	https://doaj.org/article/e2fede73cd4149599b0eaf002feba403
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Optimising recruitment to a late-phase tuberculosis clinical trial: a qualitative study exploring patient and practitioner experiences in Uzbekistan

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