Statistical issues in randomised controlled trials: a narrative synthesis
Randomised controlled trials (RCT s) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of co...
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ftdoajarticles:oai:doaj.org/article:87d64f86a6b54b9692b1b23a67d6e489 2023-05-15T15:13:05+02:00 Statistical issues in randomised controlled trials: a narrative synthesis Bolaji Emmanuel Egbewale 2015-05-01T00:00:00Z https://doi.org/10.1016/S2221-1691(15)30367-1 https://doaj.org/article/87d64f86a6b54b9692b1b23a67d6e489 EN eng Wolters Kluwer Medknow Publications http://www.sciencedirect.com/science/article/pii/S2221169115303671 https://doaj.org/toc/2221-1691 2221-1691 doi:10.1016/S2221-1691(15)30367-1 https://doaj.org/article/87d64f86a6b54b9692b1b23a67d6e489 Asian Pacific Journal of Tropical Biomedicine, Vol 5, Iss 5, Pp 354-359 (2015) Baseline comparability Covariate selection for adjustment Covariate adjustment Intention-to-treat analysis Subgroup analysis Arctic medicine. Tropical medicine RC955-962 Biology (General) QH301-705.5 article 2015 ftdoajarticles https://doi.org/10.1016/S2221-1691(15)30367-1 2022-12-31T15:38:45Z Randomised controlled trials (RCT s) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCT s to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s) should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s) and the outcome variable is more in tandem with statistical principle(s) than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-to-treat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCT s are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Asian Pacific Journal of Tropical Biomedicine 5 5 354 359 |
institution |
Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Baseline comparability Covariate selection for adjustment Covariate adjustment Intention-to-treat analysis Subgroup analysis Arctic medicine. Tropical medicine RC955-962 Biology (General) QH301-705.5 |
spellingShingle |
Baseline comparability Covariate selection for adjustment Covariate adjustment Intention-to-treat analysis Subgroup analysis Arctic medicine. Tropical medicine RC955-962 Biology (General) QH301-705.5 Bolaji Emmanuel Egbewale Statistical issues in randomised controlled trials: a narrative synthesis |
topic_facet |
Baseline comparability Covariate selection for adjustment Covariate adjustment Intention-to-treat analysis Subgroup analysis Arctic medicine. Tropical medicine RC955-962 Biology (General) QH301-705.5 |
description |
Randomised controlled trials (RCT s) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCT s to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s) should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s) and the outcome variable is more in tandem with statistical principle(s) than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-to-treat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCT s are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method. |
format |
Article in Journal/Newspaper |
author |
Bolaji Emmanuel Egbewale |
author_facet |
Bolaji Emmanuel Egbewale |
author_sort |
Bolaji Emmanuel Egbewale |
title |
Statistical issues in randomised controlled trials: a narrative synthesis |
title_short |
Statistical issues in randomised controlled trials: a narrative synthesis |
title_full |
Statistical issues in randomised controlled trials: a narrative synthesis |
title_fullStr |
Statistical issues in randomised controlled trials: a narrative synthesis |
title_full_unstemmed |
Statistical issues in randomised controlled trials: a narrative synthesis |
title_sort |
statistical issues in randomised controlled trials: a narrative synthesis |
publisher |
Wolters Kluwer Medknow Publications |
publishDate |
2015 |
url |
https://doi.org/10.1016/S2221-1691(15)30367-1 https://doaj.org/article/87d64f86a6b54b9692b1b23a67d6e489 |
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Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Asian Pacific Journal of Tropical Biomedicine, Vol 5, Iss 5, Pp 354-359 (2015) |
op_relation |
http://www.sciencedirect.com/science/article/pii/S2221169115303671 https://doaj.org/toc/2221-1691 2221-1691 doi:10.1016/S2221-1691(15)30367-1 https://doaj.org/article/87d64f86a6b54b9692b1b23a67d6e489 |
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https://doi.org/10.1016/S2221-1691(15)30367-1 |
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Asian Pacific Journal of Tropical Biomedicine |
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5 |
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5 |
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354 |
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359 |
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