Statistical methods in the analysis of multicentre HIV randomized controlled trials in the African region: a scoping review
Abstract Background The majority of phase 3 clinical trials are implemented in multiple sites or centres, which inevitably leads to a correlation between observations from the same site or centre. This correlation must be carefully considered in both the design and the statistical analysis to ensure...
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BMC
2025-01-01
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| Series: | BMC Medical Research Methodology |
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| Online Access: | https://doi.org/10.1186/s12874-024-02441-w |
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| author | Mikateko Mazinu Nomonde Gwebushe Samuel Manda Tarylee Reddy |
| author_facet | Mikateko Mazinu Nomonde Gwebushe Samuel Manda Tarylee Reddy |
| author_sort | Mikateko Mazinu |
| collection | DOAJ |
| description | Abstract Background The majority of phase 3 clinical trials are implemented in multiple sites or centres, which inevitably leads to a correlation between observations from the same site or centre. This correlation must be carefully considered in both the design and the statistical analysis to ensure an accurate interpretation of the results and reduce the risk of biased results. This scoping review aims to provide a detailed statistical method used to analyze data collected from multicentre HIV randomized controlled trials in the African region. Methods This review followed the methodological framework proposed by Arksey and O’Malley. We searched four databases (PubMed, EBSCOhost, Scopus, and Web of Science) and retrieved 977 articles, 34 of which were included in the review. Results Data charting revealed that the most used statistical methods for analysing HIV endpoints in multicentre randomized controlled trials in Africa were standard survival analysis techniques (24 articles [71%]). Approximately 47% of the articles used stratified analysis methods to account for variations across different sites. Out of 34 articles reviewed, only 6 explicitly considered intra-site correlation in the analysis. Conclusions Our scoping review provides insights into the statistical methods used to analyse HIV data in multicentre randomized controlled trials in Africa and highlights the need for standardized reporting of statistical methods. |
| format | Article |
| id | doaj-art-05a47ea6378c47e9b58028dfae7d5e2c |
| institution | Kabale University |
| issn | 1471-2288 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Research Methodology |
| spelling | doaj-art-05a47ea6378c47e9b58028dfae7d5e2c2025-01-12T12:28:49ZengBMCBMC Medical Research Methodology1471-22882025-01-0125111210.1186/s12874-024-02441-wStatistical methods in the analysis of multicentre HIV randomized controlled trials in the African region: a scoping reviewMikateko Mazinu0Nomonde Gwebushe1Samuel Manda2Tarylee Reddy3Biostatistics Research Unit, South African Medical Research CouncilBiostatistics Research Unit, South African Medical Research CouncilDepartment of Statistics, University of PretoriaBiostatistics Research Unit, South African Medical Research CouncilAbstract Background The majority of phase 3 clinical trials are implemented in multiple sites or centres, which inevitably leads to a correlation between observations from the same site or centre. This correlation must be carefully considered in both the design and the statistical analysis to ensure an accurate interpretation of the results and reduce the risk of biased results. This scoping review aims to provide a detailed statistical method used to analyze data collected from multicentre HIV randomized controlled trials in the African region. Methods This review followed the methodological framework proposed by Arksey and O’Malley. We searched four databases (PubMed, EBSCOhost, Scopus, and Web of Science) and retrieved 977 articles, 34 of which were included in the review. Results Data charting revealed that the most used statistical methods for analysing HIV endpoints in multicentre randomized controlled trials in Africa were standard survival analysis techniques (24 articles [71%]). Approximately 47% of the articles used stratified analysis methods to account for variations across different sites. Out of 34 articles reviewed, only 6 explicitly considered intra-site correlation in the analysis. Conclusions Our scoping review provides insights into the statistical methods used to analyse HIV data in multicentre randomized controlled trials in Africa and highlights the need for standardized reporting of statistical methods.https://doi.org/10.1186/s12874-024-02441-wMulticentre trialsRandomized control trialsScoping reviewHIV/AIDS trials |
| spellingShingle | Mikateko Mazinu Nomonde Gwebushe Samuel Manda Tarylee Reddy Statistical methods in the analysis of multicentre HIV randomized controlled trials in the African region: a scoping review BMC Medical Research Methodology Multicentre trials Randomized control trials Scoping review HIV/AIDS trials |
| title | Statistical methods in the analysis of multicentre HIV randomized controlled trials in the African region: a scoping review |
| title_full | Statistical methods in the analysis of multicentre HIV randomized controlled trials in the African region: a scoping review |
| title_fullStr | Statistical methods in the analysis of multicentre HIV randomized controlled trials in the African region: a scoping review |
| title_full_unstemmed | Statistical methods in the analysis of multicentre HIV randomized controlled trials in the African region: a scoping review |
| title_short | Statistical methods in the analysis of multicentre HIV randomized controlled trials in the African region: a scoping review |
| title_sort | statistical methods in the analysis of multicentre hiv randomized controlled trials in the african region a scoping review |
| topic | Multicentre trials Randomized control trials Scoping review HIV/AIDS trials |
| url | https://doi.org/10.1186/s12874-024-02441-w |
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