On clinical trial fragility due to patients lost to follow up

Abstract Background Clinical trials routinely have patients lost to follow up. We propose a methodology to understand their possible effect on the results of statistical tests by altering the concept of the fragility index to treat the outcomes of observed patients as fixed but incorporate the poten...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Benjamin R. Baer, Stephen E. Fremes, Mario Gaudino, Mary Charlson, Martin T. Wells
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Fragility index Statistical significance Research methods Loss to follow up Sensitivity analysis CABG Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/bf76edffb4524432be3b3cc45054d90e
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:bf76edffb4524432be3b3cc45054d90e
record_format	dspace
spelling	oai:doaj.org-article:bf76edffb4524432be3b3cc45054d90e2021-11-21T12:40:35ZOn clinical trial fragility due to patients lost to follow up10.1186/s12874-021-01446-z1471-2288https://doaj.org/article/bf76edffb4524432be3b3cc45054d90e2021-11-01T00:00:00Zhttps://doi.org/10.1186/s12874-021-01446-zhttps://doaj.org/toc/1471-2288Abstract Background Clinical trials routinely have patients lost to follow up. We propose a methodology to understand their possible effect on the results of statistical tests by altering the concept of the fragility index to treat the outcomes of observed patients as fixed but incorporate the potential outcomes of patients lost to follow up as random and subject to modification. Methods We reanalyse the statistical results of three clinical trials on coronary artery bypass grafting (CABG) to study the possible effect of patients lost to follow up on the treatment effect statistical significance. To do so, we introduce the LTFU-aware fragility indices as a measure of the robustness of a clinical trial’s statistical results with respect to patients lost to follow up. Results The analyses illustrate that clinical trials can either be completely robust to the outcomes of patients lost to follow up, extremely sensitive to the outcomes of patients lost to follow up, or in an intermediate state. When a clinical trial is in an intermediate state, the LTFU-aware fragility indices provide an interpretable measure to quantify the degree of fragility or robustness. Conclusions The LTFU-aware fragility indices allow researchers to rigorously explore the outcomes of patients who are lost to follow up, when their data is the appropriate kind. The LTFU-aware fragility indices are sensitivity measures in a way that the original fragility index is not.Benjamin R. BaerStephen E. FremesMario GaudinoMary CharlsonMartin T. WellsBMCarticleFragility indexStatistical significanceResearch methodsLoss to follow upSensitivity analysisCABGMedicine (General)R5-920ENBMC Medical Research Methodology, Vol 21, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Fragility index Statistical significance Research methods Loss to follow up Sensitivity analysis CABG Medicine (General) R5-920
spellingShingle	Fragility index Statistical significance Research methods Loss to follow up Sensitivity analysis CABG Medicine (General) R5-920 Benjamin R. Baer Stephen E. Fremes Mario Gaudino Mary Charlson Martin T. Wells On clinical trial fragility due to patients lost to follow up
description	Abstract Background Clinical trials routinely have patients lost to follow up. We propose a methodology to understand their possible effect on the results of statistical tests by altering the concept of the fragility index to treat the outcomes of observed patients as fixed but incorporate the potential outcomes of patients lost to follow up as random and subject to modification. Methods We reanalyse the statistical results of three clinical trials on coronary artery bypass grafting (CABG) to study the possible effect of patients lost to follow up on the treatment effect statistical significance. To do so, we introduce the LTFU-aware fragility indices as a measure of the robustness of a clinical trial’s statistical results with respect to patients lost to follow up. Results The analyses illustrate that clinical trials can either be completely robust to the outcomes of patients lost to follow up, extremely sensitive to the outcomes of patients lost to follow up, or in an intermediate state. When a clinical trial is in an intermediate state, the LTFU-aware fragility indices provide an interpretable measure to quantify the degree of fragility or robustness. Conclusions The LTFU-aware fragility indices allow researchers to rigorously explore the outcomes of patients who are lost to follow up, when their data is the appropriate kind. The LTFU-aware fragility indices are sensitivity measures in a way that the original fragility index is not.
format	article
author	Benjamin R. Baer Stephen E. Fremes Mario Gaudino Mary Charlson Martin T. Wells
author_facet	Benjamin R. Baer Stephen E. Fremes Mario Gaudino Mary Charlson Martin T. Wells
author_sort	Benjamin R. Baer
title	On clinical trial fragility due to patients lost to follow up
title_short	On clinical trial fragility due to patients lost to follow up
title_full	On clinical trial fragility due to patients lost to follow up
title_fullStr	On clinical trial fragility due to patients lost to follow up
title_full_unstemmed	On clinical trial fragility due to patients lost to follow up
title_sort	on clinical trial fragility due to patients lost to follow up
publisher	BMC
publishDate	2021
url	https://doaj.org/article/bf76edffb4524432be3b3cc45054d90e
work_keys_str_mv	AT benjaminrbaer onclinicaltrialfragilityduetopatientslosttofollowup AT stephenefremes onclinicaltrialfragilityduetopatientslosttofollowup AT mariogaudino onclinicaltrialfragilityduetopatientslosttofollowup AT marycharlson onclinicaltrialfragilityduetopatientslosttofollowup AT martintwells onclinicaltrialfragilityduetopatientslosttofollowup
_version_	1718418912533544960

On clinical trial fragility due to patients lost to follow up

Ejemplares similares