Evidence map›Paper›PMID 39773382›Full record

ArticleBMC medical research methodology2025

Statistical methods in the analysis of multicentre HIV randomized controlled trials in the African region: a scoping review.

Mikateko Mazinu, Nomonde Gwebushe, Samuel Manda, Tarylee Reddy

Abstract readScoping Review
In one paragraph

Article in BMC medical research methodology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Mikateko MazinuBiostatistics Research Unit, South African Medical Research Council, P.O Box 19070, Tygerberg, Cape Town, 7505, South Africa. mikateko.mazinu@mrc.ac.za.
Nomonde GwebusheBiostatistics Research Unit, South African Medical Research Council, P.O Box 19070, Tygerberg, Cape Town, 7505, South Africa.
Samuel MandaDepartment of Statistics, University of Pretoria, Pretoria, South Africa.
Tarylee ReddyBiostatistics Research Unit, South African Medical Research Council, P.O Box 19070, Tygerberg, Cape Town, 7505, South Africa.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsThis 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.

resultsData 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.

conclusionsOur 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.

Indexed as

HIV InfectionsMulticenter Studies as TopicRandomized Controlled Trials as TopicAfricaData Interpretation, StatisticalHumansResearch DesignHIV/AIDS trialsMulticentre trialsRandomized control trialsScoping review

Identifiers

PMID39773382
PMCPMC11707912

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.