Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards

Background Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting. Methods We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation. Results Application of the Gibbs Framework found that the trial scored ‘2’ for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner. Conclusions Comprehensive evaluation of the trial’s cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence. Trial registration PACTR201610001825403. Registered on 17 October 2016. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Siegfried, Nandi Louise [verfasserIn] Hopewell, Sally Erasmus-Claassen, Lesley-Ann Myers, Bronwyn

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	Cultural competency Diversity Reporting guidelines Randomised controlled trial Gibbs Framework GRIPP-2(SF) checklist

Anmerkung:	© The Author(s) 2022

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 23(2022), 1 vom: 29. Okt.
Übergeordnetes Werk:	volume:23 ; year:2022 ; number:1 ; day:29 ; month:10

Links:	Volltext

DOI / URN:	10.1186/s13063-022-06767-y

Katalog-ID:	SPR051094347

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520			\|a Background Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting. Methods We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation. Results Application of the Gibbs Framework found that the trial scored ‘2’ for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner. Conclusions Comprehensive evaluation of the trial’s cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence. Trial registration PACTR201610001825403. Registered on 17 October 2016.
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allfields	10.1186/s13063-022-06767-y doi (DE-627)SPR051094347 (SPR)s13063-022-06767-y-e DE-627 ger DE-627 rakwb eng Siegfried, Nandi Louise verfasserin (orcid)0000-0002-4081-1698 aut Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Background Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting. Methods We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation. Results Application of the Gibbs Framework found that the trial scored ‘2’ for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner. Conclusions Comprehensive evaluation of the trial’s cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence. Trial registration PACTR201610001825403. Registered on 17 October 2016. Cultural competency (dpeaa)DE-He213 Diversity (dpeaa)DE-He213 Reporting guidelines (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Gibbs Framework (dpeaa)DE-He213 GRIPP-2(SF) checklist (dpeaa)DE-He213 Hopewell, Sally (orcid)0000-0002-6881-6984 aut Erasmus-Claassen, Lesley-Ann (orcid)0000-0002-1136-1202 aut Myers, Bronwyn (orcid)0000-0003-0235-6716 aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 29. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:29 month:10 https://dx.doi.org/10.1186/s13063-022-06767-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 29 10
spelling	10.1186/s13063-022-06767-y doi (DE-627)SPR051094347 (SPR)s13063-022-06767-y-e DE-627 ger DE-627 rakwb eng Siegfried, Nandi Louise verfasserin (orcid)0000-0002-4081-1698 aut Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Background Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting. Methods We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation. Results Application of the Gibbs Framework found that the trial scored ‘2’ for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner. Conclusions Comprehensive evaluation of the trial’s cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence. Trial registration PACTR201610001825403. Registered on 17 October 2016. Cultural competency (dpeaa)DE-He213 Diversity (dpeaa)DE-He213 Reporting guidelines (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Gibbs Framework (dpeaa)DE-He213 GRIPP-2(SF) checklist (dpeaa)DE-He213 Hopewell, Sally (orcid)0000-0002-6881-6984 aut Erasmus-Claassen, Lesley-Ann (orcid)0000-0002-1136-1202 aut Myers, Bronwyn (orcid)0000-0003-0235-6716 aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 29. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:29 month:10 https://dx.doi.org/10.1186/s13063-022-06767-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 29 10
allfields_unstemmed	10.1186/s13063-022-06767-y doi (DE-627)SPR051094347 (SPR)s13063-022-06767-y-e DE-627 ger DE-627 rakwb eng Siegfried, Nandi Louise verfasserin (orcid)0000-0002-4081-1698 aut Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Background Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting. Methods We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation. Results Application of the Gibbs Framework found that the trial scored ‘2’ for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner. Conclusions Comprehensive evaluation of the trial’s cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence. Trial registration PACTR201610001825403. Registered on 17 October 2016. Cultural competency (dpeaa)DE-He213 Diversity (dpeaa)DE-He213 Reporting guidelines (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Gibbs Framework (dpeaa)DE-He213 GRIPP-2(SF) checklist (dpeaa)DE-He213 Hopewell, Sally (orcid)0000-0002-6881-6984 aut Erasmus-Claassen, Lesley-Ann (orcid)0000-0002-1136-1202 aut Myers, Bronwyn (orcid)0000-0003-0235-6716 aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 29. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:29 month:10 https://dx.doi.org/10.1186/s13063-022-06767-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 29 10
allfieldsGer	10.1186/s13063-022-06767-y doi (DE-627)SPR051094347 (SPR)s13063-022-06767-y-e DE-627 ger DE-627 rakwb eng Siegfried, Nandi Louise verfasserin (orcid)0000-0002-4081-1698 aut Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Background Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting. Methods We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation. Results Application of the Gibbs Framework found that the trial scored ‘2’ for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner. Conclusions Comprehensive evaluation of the trial’s cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence. Trial registration PACTR201610001825403. Registered on 17 October 2016. Cultural competency (dpeaa)DE-He213 Diversity (dpeaa)DE-He213 Reporting guidelines (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Gibbs Framework (dpeaa)DE-He213 GRIPP-2(SF) checklist (dpeaa)DE-He213 Hopewell, Sally (orcid)0000-0002-6881-6984 aut Erasmus-Claassen, Lesley-Ann (orcid)0000-0002-1136-1202 aut Myers, Bronwyn (orcid)0000-0003-0235-6716 aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 29. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:29 month:10 https://dx.doi.org/10.1186/s13063-022-06767-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 29 10
allfieldsSound	10.1186/s13063-022-06767-y doi (DE-627)SPR051094347 (SPR)s13063-022-06767-y-e DE-627 ger DE-627 rakwb eng Siegfried, Nandi Louise verfasserin (orcid)0000-0002-4081-1698 aut Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Background Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting. Methods We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation. Results Application of the Gibbs Framework found that the trial scored ‘2’ for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner. Conclusions Comprehensive evaluation of the trial’s cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence. Trial registration PACTR201610001825403. Registered on 17 October 2016. Cultural competency (dpeaa)DE-He213 Diversity (dpeaa)DE-He213 Reporting guidelines (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Gibbs Framework (dpeaa)DE-He213 GRIPP-2(SF) checklist (dpeaa)DE-He213 Hopewell, Sally (orcid)0000-0002-6881-6984 aut Erasmus-Claassen, Lesley-Ann (orcid)0000-0002-1136-1202 aut Myers, Bronwyn (orcid)0000-0003-0235-6716 aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 29. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:29 month:10 https://dx.doi.org/10.1186/s13063-022-06767-y kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 29 10
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spellingShingle	Siegfried, Nandi Louise misc Cultural competency misc Diversity misc Reporting guidelines misc Randomised controlled trial misc Gibbs Framework misc GRIPP-2(SF) checklist Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards
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topic_title	Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards Cultural competency (dpeaa)DE-He213 Diversity (dpeaa)DE-He213 Reporting guidelines (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Gibbs Framework (dpeaa)DE-He213 GRIPP-2(SF) checklist (dpeaa)DE-He213
topic	misc Cultural competency misc Diversity misc Reporting guidelines misc Randomised controlled trial misc Gibbs Framework misc GRIPP-2(SF) checklist
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title	Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards
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title_full	Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards
author_sort	Siegfried, Nandi Louise
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author_browse	Siegfried, Nandi Louise Hopewell, Sally Erasmus-Claassen, Lesley-Ann Myers, Bronwyn
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title_sort	evaluation of cultural competency in a south african cluster randomised controlled trial: lessons learned for trial reporting standards
title_auth	Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards
abstract	Background Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting. Methods We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation. Results Application of the Gibbs Framework found that the trial scored ‘2’ for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner. Conclusions Comprehensive evaluation of the trial’s cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence. Trial registration PACTR201610001825403. Registered on 17 October 2016. © The Author(s) 2022
abstractGer	Background Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting. Methods We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation. Results Application of the Gibbs Framework found that the trial scored ‘2’ for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner. Conclusions Comprehensive evaluation of the trial’s cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence. Trial registration PACTR201610001825403. Registered on 17 October 2016. © The Author(s) 2022
abstract_unstemmed	Background Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting. Methods We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation. Results Application of the Gibbs Framework found that the trial scored ‘2’ for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner. Conclusions Comprehensive evaluation of the trial’s cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence. Trial registration PACTR201610001825403. Registered on 17 October 2016. © The Author(s) 2022
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title_short	Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards
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author2	Hopewell, Sally Erasmus-Claassen, Lesley-Ann Myers, Bronwyn
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