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Consolidated guidance for behavioral intervention pilot and feasibility studies

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Τίτλος: Consolidated guidance for behavioral intervention pilot and feasibility studies
Συγγραφείς: Pfledderer, CD, von Klinggraeff, L, Burkart, S, da Silva Bandeira, A, Lubans, DR, Jago, R, Okely, AD, Van Sluijs, Esther, Ioannidis, JPA, Thrasher, JF, Li, X, Beets, MW
Στοιχεία εκδότη: BMC
Mrc Epidemiology Unit
Έτος έκδοσης: 2024
Συλλογή: Apollo - University of Cambridge Repository
Θεματικοί όροι: 4203 Health Services and Systems, 42 Health Sciences, Clinical Research, Behavioral and Social Science, 8.4 Research design and methodologies (health services)
Περιγραφή: 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 well-know 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 ...
Τύπος εγγράφου: article in journal/newspaper
Περιγραφή αρχείου: application/pdf
Γλώσσα: English
Relation: https://www.repository.cam.ac.uk/handle/1810/366622
Διαθεσιμότητα: https://www.repository.cam.ac.uk/handle/1810/366622
Rights: Attribution 4.0 International ; https://creativecommons.org/licenses/by/4.0/
Αριθμός Καταχώρησης: edsbas.A9A76C09
Βάση Δεδομένων: BASE
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  Data: Consolidated guidance for behavioral intervention pilot and feasibility studies
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  Data: BMC<br />Mrc Epidemiology Unit
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  Data: 2024
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  Data: 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 well-know 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 ...
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        Type: general
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