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Consolidated guidance for behavioral intervention pilot and feasibility studies
Acknowledgements: The authors would like to thank all experts who provided valuable input through the Delphi process of this study.Abstract
Background
In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences.
Methods
To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of a well-known PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences.
Results
A total of 496 authors were invited to take part in the three-round Delphi survey (round 1, N = 46; round 2, N = 24; round 3, N = 22). A set of twenty considerations, broadly categorized into six themes (intervention design, study design, conduct of trial, implementation of intervention, statistical analysis, and reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading.
Conclusion
We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.
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Legalization by Commodification: The (Ir)relevance of Fashion Styles and Brands in Street Gangster Performance
Throughout the history of gang ethnography, particular dress codes and fashion styles have always been perceived as representations of gang culture. However, since its beginning, many young men enjoyed gang fashion without ‘being’ a gang member. Today, an ever-growing global fashion industry transforms street styles into commodities which are sold to and consumed by a much wider audience than ‘the streets’ inhabitants. This endows street styles, and in this chapter gang fashion, with a semantic ambiguity. While keeping its criminal connotations, gang aesthetics are normalized in the commodification process. This process enables, for instance, consumers of gangsta rap to enjoy gang fashion, but the semantic ambiguity also renders ‘true’ gangster performance more difficult
International progress in cancer gene therapy
We overview the current status and most recent developments in the field of cancer gene therapy from an international viewpoint. We have largely based our review on presentations from the eigth annual meeting of the International Society for Cell and Gene Therapy of Cancer held in Mumbai, India (www.iscgt.com and www.iscgtindia.com). This has afforded us with the opportunity to describe the most recently published and unpublished data in the field of cancer gene therapy, gaining an insight into the priorities in this field today. In doing so, we hope to have provided a state of the art review of cancer gene therapy, with the help of some of the best-known researchers in the field. In addition, due to the location of the meeting, we had a unique opportunity to listen to some of the seminal cancer gene therapy work being performed in India at this tim