Use of external evidence for design and Bayesian analysis of clinical trials: a qualitative study of trialists’ views

Abstract Background Evidence from previous studies is often used relatively informally in the design of clinical trials: for example, a systematic review to indicate whether a gap in the current evidence base justifies a new trial. External evidence can be used more formally in both trial design and...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Gemma L. Clayton, Daisy Elliott, Julian P. T. Higgins, Hayley E. Jones
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Evidence synthesis Bayesian analysis Trials Qualitative Informative prior distributions Meta-epidemiology Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/a599ddec1049466ca83a89861a7929c5
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:a599ddec1049466ca83a89861a7929c5
record_format	dspace
spelling	oai:doaj.org-article:a599ddec1049466ca83a89861a7929c52021-11-14T12:31:21ZUse of external evidence for design and Bayesian analysis of clinical trials: a qualitative study of trialists’ views10.1186/s13063-021-05759-81745-6215https://doaj.org/article/a599ddec1049466ca83a89861a7929c52021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05759-8https://doaj.org/toc/1745-6215Abstract Background Evidence from previous studies is often used relatively informally in the design of clinical trials: for example, a systematic review to indicate whether a gap in the current evidence base justifies a new trial. External evidence can be used more formally in both trial design and analysis, by explicitly incorporating a synthesis of it in a Bayesian framework. However, it is unclear how common this is in practice or the extent to which it is considered controversial. In this qualitative study, we explored attitudes towards, and experiences of, trialists in incorporating synthesised external evidence through the Bayesian design or analysis of a trial. Methods Semi-structured interviews were conducted with 16 trialists: 13 statisticians and three clinicians. Participants were recruited across several universities and trials units in the United Kingdom using snowball and purposeful sampling. Data were analysed using thematic analysis and techniques of constant comparison. Results Trialists used existing evidence in many ways in trial design, for example, to justify a gap in the evidence base and inform parameters in sample size calculations. However, no one in our sample reported using such evidence in a Bayesian framework. Participants tended to equate Bayesian analysis with the incorporation of prior information on the intervention effect and were less aware of the potential to incorporate data on other parameters. When introduced to the concepts, many trialists felt they could be making more use of existing data to inform the design and analysis of a trial in particular scenarios. For example, some felt existing data could be used more formally to inform background adverse event rates, rather than relying on clinical opinion as to whether there are potential safety concerns. However, several barriers to implementing these methods in practice were identified, including concerns about the relevance of external data, acceptability of Bayesian methods, lack of confidence in Bayesian methods and software, and practical issues, such as difficulties accessing relevant data. Conclusions Despite trialists recognising that more formal use of external evidence could be advantageous over current approaches in some areas and useful as sensitivity analyses, there are still barriers to such use in practice.Gemma L. ClaytonDaisy ElliottJulian P. T. HigginsHayley E. JonesBMCarticleEvidence synthesisBayesian analysisTrialsQualitativeInformative prior distributionsMeta-epidemiologyMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Evidence synthesis Bayesian analysis Trials Qualitative Informative prior distributions Meta-epidemiology Medicine (General) R5-920
spellingShingle	Evidence synthesis Bayesian analysis Trials Qualitative Informative prior distributions Meta-epidemiology Medicine (General) R5-920 Gemma L. Clayton Daisy Elliott Julian P. T. Higgins Hayley E. Jones Use of external evidence for design and Bayesian analysis of clinical trials: a qualitative study of trialists’ views
description	Abstract Background Evidence from previous studies is often used relatively informally in the design of clinical trials: for example, a systematic review to indicate whether a gap in the current evidence base justifies a new trial. External evidence can be used more formally in both trial design and analysis, by explicitly incorporating a synthesis of it in a Bayesian framework. However, it is unclear how common this is in practice or the extent to which it is considered controversial. In this qualitative study, we explored attitudes towards, and experiences of, trialists in incorporating synthesised external evidence through the Bayesian design or analysis of a trial. Methods Semi-structured interviews were conducted with 16 trialists: 13 statisticians and three clinicians. Participants were recruited across several universities and trials units in the United Kingdom using snowball and purposeful sampling. Data were analysed using thematic analysis and techniques of constant comparison. Results Trialists used existing evidence in many ways in trial design, for example, to justify a gap in the evidence base and inform parameters in sample size calculations. However, no one in our sample reported using such evidence in a Bayesian framework. Participants tended to equate Bayesian analysis with the incorporation of prior information on the intervention effect and were less aware of the potential to incorporate data on other parameters. When introduced to the concepts, many trialists felt they could be making more use of existing data to inform the design and analysis of a trial in particular scenarios. For example, some felt existing data could be used more formally to inform background adverse event rates, rather than relying on clinical opinion as to whether there are potential safety concerns. However, several barriers to implementing these methods in practice were identified, including concerns about the relevance of external data, acceptability of Bayesian methods, lack of confidence in Bayesian methods and software, and practical issues, such as difficulties accessing relevant data. Conclusions Despite trialists recognising that more formal use of external evidence could be advantageous over current approaches in some areas and useful as sensitivity analyses, there are still barriers to such use in practice.
format	article
author	Gemma L. Clayton Daisy Elliott Julian P. T. Higgins Hayley E. Jones
author_facet	Gemma L. Clayton Daisy Elliott Julian P. T. Higgins Hayley E. Jones
author_sort	Gemma L. Clayton
title	Use of external evidence for design and Bayesian analysis of clinical trials: a qualitative study of trialists’ views
title_short	Use of external evidence for design and Bayesian analysis of clinical trials: a qualitative study of trialists’ views
title_full	Use of external evidence for design and Bayesian analysis of clinical trials: a qualitative study of trialists’ views
title_fullStr	Use of external evidence for design and Bayesian analysis of clinical trials: a qualitative study of trialists’ views
title_full_unstemmed	Use of external evidence for design and Bayesian analysis of clinical trials: a qualitative study of trialists’ views
title_sort	use of external evidence for design and bayesian analysis of clinical trials: a qualitative study of trialists’ views
publisher	BMC
publishDate	2021
url	https://doaj.org/article/a599ddec1049466ca83a89861a7929c5
work_keys_str_mv	AT gemmalclayton useofexternalevidencefordesignandbayesiananalysisofclinicaltrialsaqualitativestudyoftrialistsviews AT daisyelliott useofexternalevidencefordesignandbayesiananalysisofclinicaltrialsaqualitativestudyoftrialistsviews AT julianpthiggins useofexternalevidencefordesignandbayesiananalysisofclinicaltrialsaqualitativestudyoftrialistsviews AT hayleyejones useofexternalevidencefordesignandbayesiananalysisofclinicaltrialsaqualitativestudyoftrialistsviews
_version_	1718429184761528320

Use of external evidence for design and Bayesian analysis of clinical trials: a qualitative study of trialists’ views

Ejemplares similares