Les méthodes adaptatives : quand et comment les utiliser dans les essais cliniques ?

Porcher, Raphaël; Lecocq, B.; Vray, Muriel

doi:10.2515/therapie/2011042

Cited by 4 publications

(1 citation statement)

References 33 publications

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“…The review found some key publications that discussed why the reporting of AD trials requires special consideration and reporting suggestions or recommendations for particular types of AD trials [ 23 , 25 , 33 , 34 , 38 , 45 , 51 , 53 – 61 ]. ADs are not immune to potential biases and limitations despite their appealing nature and promising benefits [ 9 , 50 , 53 ].…”

Section: Methodsmentioning

confidence: 99%

Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

Dimairo

Coates

Pallmann

et al. 2018

BMC Med

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BackgroundAdequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs. Currently, there are deficiencies in the reporting of AD trials. To overcome this, we have developed a consensus-driven extension to the CONSORT statement for randomised trials using an AD. This paper describes the processes and methods used to develop this extension rather than detailed explanation of the guideline.MethodsWe developed the guideline in seven overlapping stages:Building on prior research to inform the need for a guideline;A scoping literature review to inform future stages;Drafting the first checklist version involving an External Expert Panel;A two-round Delphi process involving international, multidisciplinary, and cross-sector key stakeholders;A consensus meeting to advise which reporting items to retain through voting, and to discuss the structure of what to include in the supporting explanation and elaboration (E&E) document;Refining and finalising the checklist; andWriting-up and dissemination of the E&E document.The CONSORT Executive Group oversaw the entire development process.ResultsDelphi survey response rates were 94/143 (66%), 114/156 (73%), and 79/143 (55%) in rounds 1, 2, and across both rounds, respectively. Twenty-seven delegates from Europe, the USA, and Asia attended the consensus meeting. The main checklist has seven new and nine modified items and six unchanged items with expanded E&E text to clarify further considerations for ADs. The abstract checklist has one new and one modified item together with an unchanged item with expanded E&E text. The E&E document will describe the scope of the guideline, the definition of an AD, and some types of ADs and trial adaptations and explain each reporting item in detail including case studies.ConclusionsWe hope that making the development processes, methods, and all supporting information that aided decision-making transparent will enhance the acceptability and quick uptake of the guideline. This will also help other groups when developing similar CONSORT extensions. The guideline is applicable to all randomised trials with an AD and contains minimum reporting requirements.Electronic supplementary materialThe online version of this article (10.1186/s12916-018-1196-2) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

Dimairo

Coates

Pallmann

et al. 2018

BMC Med

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Overcoming research barriers in Chagas disease—designing effective implementation science

Henao‐Martínez

Colborn

Parra-Henao³

2016

Parasitol Res

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Chagas disease is a complex tropical parasitic infection. It affects a significant portion of the population in Latin America, especially in areas of poverty and poor access to health care. It also affects immigrants in high-income countries who lack access to health care due to their legal status. Millions of people are at risk of contracting the disease, and approximately 30 % of chronically infected patients will develop cardiomyopathy. The cost of caring for patients that have been infected is substantial. Basic science research has introduced new concepts and knowledge for the parasite and vector biology as well as better understanding of the pathophysiology of the disease. These research findings nevertheless require effective and timely translation into clinical practice. Likewise, the design of new research projects should account for the multiple system-based barriers. Implementation science facilitates the applicability of research findings and identifies barriers to its execution. Creation of implementation science measures to reach and sustain research programs with greater potential to impact Chagas disease are lacking. This point of view proposes opportunities for implementation science in Chagas disease and strategies for researching effective interventions for preventing and treating the disease.

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Méthodologie et gestion des essais cliniques à petits effectifs pour les maladies rares

Micallef

2012

La Presse Médicale

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Les méthodes adaptatives : quand et comment les utiliser dans les essais cliniques ?

Cited by 4 publications

References 33 publications

Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

Overcoming research barriers in Chagas disease—designing effective implementation science

Méthodologie et gestion des essais cliniques à petits effectifs pour les maladies rares

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