Pilot and feasibility studies: extending the conceptual framework

Christine Bond; Gillian A. Lancaster; Mike Campbell; Claire Chan; Saskia Eddy; Sally  Hopewell; Katie Mellor; Lehana Thabane; Sandra Eldridge

doi:10.1186/s40814-023-01233-1

Pilot and feasibility studies: extending the conceptual framework

Christine Bond^* (Corresponding Author), Gillian A. Lancaster, Mike Campbell, Claire Chan, Saskia Eddy, Sally Hopewell, Katie Mellor, Lehana Thabane, Sandra Eldridge

^*Corresponding author for this work

Applied Health Sciences

Research output: Contribution to journal › Article › peer-review

10 Citations (Scopus)

4 Downloads (Pure)

Abstract

In 2016, we published a conceptual framework outlining the conclusions of our work in defining pilot and feasibility studies. Since then, the CONSORT extension to randomised pilot and feasibility trials has been published and there have been further developments in the pilot study landscape. In this paper, we revisit and extend our framework to incorporate the various feasibility pathways open to researchers, which include internal pilot studies. We consider, with examples, when different approaches to feasibility and pilot studies are more effective and efficient, taking into account the pragmatic decisions that may need to be made. The ethical issues involved in pilot studies are discussed. We end with a consideration of the funders’ perspective in making difficult resource decisions to include feasibility work and the policy implications of these; throughout, we provide examples of the uncertainties and compromises that researchers have to navigate to make progress in the most efficient way.

Original language	English
Article number	24
Number of pages	10
Journal	Pilot and Feasibility Studies
Volume	9
DOIs	https://doi.org/10.1186/s40814-023-01233-1
Publication status	Published - 9 Feb 2023

Bibliographical note

Acknowledgements
Not applicable.

Funding
No specific funding was received for this work.

Data Availability Statement

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.

Keywords

Internal Pilot
External Pilot
Definitions
Concepts
Uncertainties
randomised controlled trial (RCT)
Feasibility
Reporting
Framework

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Cite this

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abstract = "In 2016, we published a conceptual framework outlining the conclusions of our work in defining pilot and feasibility studies. Since then, the CONSORT extension to randomised pilot and feasibility trials has been published and there have been further developments in the pilot study landscape. In this paper, we revisit and extend our framework to incorporate the various feasibility pathways open to researchers, which include internal pilot studies. We consider, with examples, when different approaches to feasibility and pilot studies are more effective and efficient, taking into account the pragmatic decisions that may need to be made. The ethical issues involved in pilot studies are discussed. We end with a consideration of the funders{\textquoteright} perspective in making difficult resource decisions to include feasibility work and the policy implications of these; throughout, we provide examples of the uncertainties and compromises that researchers have to navigate to make progress in the most efficient way.",

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note = "Acknowledgements Not applicable. Funding No specific funding was received for this work.",

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language = "English",

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AU - Bond, Christine

AU - Lancaster, Gillian A.

AU - Campbell, Mike

AU - Chan, Claire

AU - Eddy, Saskia

AU - Hopewell, Sally

AU - Mellor, Katie

AU - Thabane, Lehana

AU - Eldridge, Sandra

N1 - Acknowledgements Not applicable. Funding No specific funding was received for this work.

PY - 2023/2/9

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AB - In 2016, we published a conceptual framework outlining the conclusions of our work in defining pilot and feasibility studies. Since then, the CONSORT extension to randomised pilot and feasibility trials has been published and there have been further developments in the pilot study landscape. In this paper, we revisit and extend our framework to incorporate the various feasibility pathways open to researchers, which include internal pilot studies. We consider, with examples, when different approaches to feasibility and pilot studies are more effective and efficient, taking into account the pragmatic decisions that may need to be made. The ethical issues involved in pilot studies are discussed. We end with a consideration of the funders’ perspective in making difficult resource decisions to include feasibility work and the policy implications of these; throughout, we provide examples of the uncertainties and compromises that researchers have to navigate to make progress in the most efficient way.

KW - Internal Pilot

KW - External Pilot

KW - Definitions

KW - Concepts

KW - Uncertainties

KW - randomised controlled trial (RCT)

KW - Feasibility

KW - Reporting

KW - Framework

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JO - Pilot and Feasibility Studies

JF - Pilot and Feasibility Studies

M1 - 24

ER -

Pilot and feasibility studies: extending the conceptual framework

Abstract

Bibliographical note

Data Availability Statement

Keywords

Access to Document

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Cite this