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Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines.

ABSTRACT: The multicenter phase III preclinical trial concept is currently discussed to enhance the predictive value of preclinical stroke research. After public announcement, we collected a community feedback on the concept with emphasis on potential design features and guidelines by an anonymous survey. Response analysis was conducted after plausibility checks by applying qualitative and quantitative measures. Most respondents supported the concept, including the implementation of a centralized steering committee. Based on received feedback, we suggest careful, stepwise implementation and to leave selected competencies and endpoint analysis at the discretion of participating centers. Strict application of quality assurance methods is accepted, but should be harmonized. However, received responses also indicate that the application of particular quality assurance models may require more attention throughout the community. Interestingly, clear and pragmatic preferences were given regarding publication and financing, suggesting the establishing of writing committees similar to large-scale clinical trials and global funding resources for financial support. The broad acceptance among research community encourages phase III preclinical trial implementation.

SUBMITTER: Boltze J

PROVIDER: S-EPMC4927600 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines.

Boltze Johannes J Wagner Daniel-Christoph DC Henninger Nils N Plesnila Nikolaus N Ayata Cenk C

Translational stroke research 20160614 4

The multicenter phase III preclinical trial concept is currently discussed to enhance the predictive value of preclinical stroke research. After public announcement, we collected a community feedback on the concept with emphasis on potential design features and guidelines by an anonymous survey. Response analysis was conducted after plausibility checks by applying qualitative and quantitative measures. Most respondents supported the concept, including the implementation of a centralized steering ...[more]

PMID: 27297402

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Project description:BackgroundNovel technical solutions are called for to promote home-based exercise among community-dwelling stroke survivors supported by their caregivers. Lack of resources and knowledge about how to accomplish it, has been demonstrated. The objective of this study is to describe in detail the development of ActivABLES, a technical intervention to promote home-based exercise and physical activity engagement of community-dwelling stroke survivors with support from their caregivers.MethodsThe technical development process of ActivABLES was guided by the Medical Research Council (MRC) framework for development and evaluation of complex interventions as well as by principles of human-centred design and co-design. The main steps included: (1) Synthesis of evidence supporting the inclusion of balance exercises, mobility and walking exercises and exercises for the upper arm; (2) Implementation of initial user studies with qualitative data collection from individual interviews with stroke survivors, and focus group interviews with caregivers and health professionals; (3) Preliminary testing of eight prototypes with seven stroke survivors and their caregivers.ResultsAfter the preliminary testing of eight prototypes, four prototypes were not further developed whereas four prototypes were modified further. In addition, two new prototypes were developed, leaving six prototypes for further modification: 1) ActivFOAM for balance exercises, 2) WalkingSTARR to facilitate walking, 3) ActivBALL for hand exercises, 4) ActivSTICKS for upper arm exercises, and 5) ActivLAMP and 6) ActivTREE which both give visual feedback on progress of daily exercise and physical activities. ActivFOAM, ActivBALL and ActivSTICKS are all connected to a tablet where exercise instructions are given. All the exercise prototypes can be connected to ActivLAMP and ActivTREE to give feedback on how much exercise the user has done. Settings can be individualised and recommended daily time and/or repetition can easily be changed as the user progresses to higher activity levels.ConclusionsThe development process of ActivABLES was guided by the principles of human-centred design, with iterative testing of future users, and by the MRC framework of complex intervention, with a repeated process of development and testing. This process resulted in six prototypes which are available for feasibility testing among a small group of community-dwelling stroke survivors.

Dataset Information

Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines.

Publications

Phase III Preclinical Trials in Translational Stroke Research: Community Response on Framework and Guidelines.

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