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Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia
This manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate the efficacy of attractive targeted sugar baits (ATSB) described in an already published protocol. The master SAP contains an overarching plan for all three trials, which can be a...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10685482/ https://www.ncbi.nlm.nih.gov/pubmed/38031086 http://dx.doi.org/10.1186/s13063-023-07762-7 |
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author | Yukich, Joshua Eisele, Thomas P. terKuile, Feiko Ashton, Ruth Staedke, Sarah Harris, Angela F. Johnson, Paul C. D. Sarrassat, Sophie Lesosky, Maia Bradley, John Kleinschmidt, Immo Littrell, Megan |
author_facet | Yukich, Joshua Eisele, Thomas P. terKuile, Feiko Ashton, Ruth Staedke, Sarah Harris, Angela F. Johnson, Paul C. D. Sarrassat, Sophie Lesosky, Maia Bradley, John Kleinschmidt, Immo Littrell, Megan |
author_sort | Yukich, Joshua |
collection | PubMed |
description | This manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate the efficacy of attractive targeted sugar baits (ATSB) described in an already published protocol. The master SAP contains an overarching plan for all three trials, which can be adapted to trial-specific circumstances. The primary objective of the trials is to evaluate the efficacy of ATSB in the presence of universal vector control coverage with insecticide-treated nets (ITN) or indoor residual spraying (IRS) after two transmission seasons on clinical malaria incidence as compared with universal vector control coverage with ITN or IRS alone. The primary outcome measure is the incidence rate of clinical malaria, assessed in cohorts aged 12 months to less than 15 years (≥ 5 years to 15 years in Mali) during monthly follow-up visits. The primary unadjusted analysis will be conducted on the intention-to-treat analysis population without adjustment for any anticipated confounding variables. The primary outcome will be analyzed using a multi-level model constructed on a generalized linear model framework with a Poisson likelihood and a log link function. Random intercepts will be included for each study cluster and a fixed effect for study-arm. The analyst will be blinded to study arm assignment. Several secondary outcomes will be analyzed, as well as a pooled analysis (individual patient data meta-analysis) across the three trial sites. Additionally, a standard meta-analysis is expected to be conducted using combined data from all sites. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07762-7. |
format | Online Article Text |
id | pubmed-10685482 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-106854822023-11-30 Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia Yukich, Joshua Eisele, Thomas P. terKuile, Feiko Ashton, Ruth Staedke, Sarah Harris, Angela F. Johnson, Paul C. D. Sarrassat, Sophie Lesosky, Maia Bradley, John Kleinschmidt, Immo Littrell, Megan Trials Research This manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate the efficacy of attractive targeted sugar baits (ATSB) described in an already published protocol. The master SAP contains an overarching plan for all three trials, which can be adapted to trial-specific circumstances. The primary objective of the trials is to evaluate the efficacy of ATSB in the presence of universal vector control coverage with insecticide-treated nets (ITN) or indoor residual spraying (IRS) after two transmission seasons on clinical malaria incidence as compared with universal vector control coverage with ITN or IRS alone. The primary outcome measure is the incidence rate of clinical malaria, assessed in cohorts aged 12 months to less than 15 years (≥ 5 years to 15 years in Mali) during monthly follow-up visits. The primary unadjusted analysis will be conducted on the intention-to-treat analysis population without adjustment for any anticipated confounding variables. The primary outcome will be analyzed using a multi-level model constructed on a generalized linear model framework with a Poisson likelihood and a log link function. Random intercepts will be included for each study cluster and a fixed effect for study-arm. The analyst will be blinded to study arm assignment. Several secondary outcomes will be analyzed, as well as a pooled analysis (individual patient data meta-analysis) across the three trial sites. Additionally, a standard meta-analysis is expected to be conducted using combined data from all sites. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07762-7. BioMed Central 2023-11-29 /pmc/articles/PMC10685482/ /pubmed/38031086 http://dx.doi.org/10.1186/s13063-023-07762-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Yukich, Joshua Eisele, Thomas P. terKuile, Feiko Ashton, Ruth Staedke, Sarah Harris, Angela F. Johnson, Paul C. D. Sarrassat, Sophie Lesosky, Maia Bradley, John Kleinschmidt, Immo Littrell, Megan Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia |
title | Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia |
title_full | Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia |
title_fullStr | Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia |
title_full_unstemmed | Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia |
title_short | Master statistical analysis plan: attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia |
title_sort | master statistical analysis plan: attractive targeted sugar bait phase iii trials in kenya, mali, and zambia |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10685482/ https://www.ncbi.nlm.nih.gov/pubmed/38031086 http://dx.doi.org/10.1186/s13063-023-07762-7 |
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