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Table 1 A chronology of guidance and evidence illustrating the evolving feasibility and pilot study landscape from our perspective

From: Pilot and feasibility studies: extending the conceptual framework

Time frame

Date and author

Key points

Pre 2008

2004 Lancaster [4]

Seminal publication: No formal guidance on what constitutes a pilot study; recommendations made for good practice. Editors reluctant to publish.

2008-15

2008 MRC Guidance [8]

No absolute definition for pilot or feasibility studies but emphasised the need to conduct pilot and feasibility work to identify and address problems that might occur in subsequent RCTs

 

2010 Thabane [5]

Demonstrated inconsistent and synonymous use of terms pilot and feasibility

 

2010 NIHR [7]

Stated that the terms feasibility and pilot were mutually exclusive

 

2010 Arain [6]

Demonstrated that in the literature studies described as feasibility or pilot had different characteristics. Editors ‘loathe to publish studies described as 'pilot”.

 

2011

Workshop on pilot studies, led by Sandra Eldridge (SE), Gillian Lancaster (GL), Mike Campbell (MC) and Sally Kerry, and attended by Christine Bond (CB), held at Annual Scientific meeting of the Society of Academic Primary Care in Bristol [10]. Outcome of the workshop was a decision to develop a CONSORT extension for pilot and feasibility studies.

 

2012

The Pilot and Feasibility Studies (PAFS) group was formed by SE, CB, GL, MC with Sally Hopewell (SH), Lehana Thabane (LT) and Claire Chan (CC) invited to join the group to develop the reporting checklist using a consensus approach [10].

 

2015 NIHR glossary [11]

Modified wording of descriptions for mutually exclusive pilot and feasibility studies

 

Pilot and feasibility studies journal official launch (2015) [12]

BMC launched Pilot and Feasibility Studies journal with Gill Lancaster as Editor in Chief in 2014. The rapid growth of the journal led to Lehana Thabane joining as co Editor in Chief in 2017

2016 to date

2016 Eldridge [1]

PAFS group suggests that feasibility is the overarching concept. All studies addressing feasibility can be classified as feasibility studies but only a subset are pilot studies

 

Consort extension guidance 2016 [13, 14]

CONSORT extension for pilot and feasibility studies published in BMJ and Pilot and Feasibility Studies

 

March 2018

GuEST consensus workshop [15]

SE, CB, GL invited to MRC GuEST Consensus Workshop on exploratory studies

 

May 2019

Internal pilot workshop [16]

Growing interest in internal pilot studies. SE, CB, SH, GL and MC invited to attend MRC Hubs for Trials Methodology workshop to discuss internal pilot studies.