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Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study

Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study
Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study
Objectives To assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs.

Study design Cross-sectional study.

Setting Both groups included NIHR HTA programme funded studies in the period 1 January 2010–31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study.

Main outcome measures The proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of ‘HTA funded’ trials which used internal and external pilot and feasibility studies to inform the design of the trial.

Results Group 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed were testing recruitment (100% in both groups), feasibility (83%, 100%) and suggestions for further study/investigation (83%, 100%). Group 2 identified 161 ‘HTA funded’ applications: 59 cited an external pilot/feasibility study where testing recruitment (50%, 73%) and feasibility (42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study where testing recruitment (93%, 100%) and feasibility (44%, 92%) were the most common study elements reported.

Conclusions ‘HTA funded’ research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.
2044-6055
1-9
Blatch-Jones, Amanda
6bb7aa9c-776b-4bdd-be4e-cf67abd05652
Ashton-Key, Martin
5994ca63-021e-44b1-86c4-b7ae53321101
Kirkpatrick, Emma V
ef4472be-90bf-400a-b100-e9d26cb907fc
Pek, Wei
bb2f78d3-78b2-4a9e-a65a-7bae5fbe6759
Blatch-Jones, Amanda
6bb7aa9c-776b-4bdd-be4e-cf67abd05652
Ashton-Key, Martin
5994ca63-021e-44b1-86c4-b7ae53321101
Kirkpatrick, Emma V
ef4472be-90bf-400a-b100-e9d26cb907fc
Pek, Wei
bb2f78d3-78b2-4a9e-a65a-7bae5fbe6759

Blatch-Jones, Amanda, Ashton-Key, Martin, Kirkpatrick, Emma V and Pek, Wei (2018) Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study. BMJ Open, 8 (9), 1-9. (doi:10.1136/bmjopen-2018-022233).

Record type: Article

Abstract

Objectives To assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs.

Study design Cross-sectional study.

Setting Both groups included NIHR HTA programme funded studies in the period 1 January 2010–31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study.

Main outcome measures The proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of ‘HTA funded’ trials which used internal and external pilot and feasibility studies to inform the design of the trial.

Results Group 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed were testing recruitment (100% in both groups), feasibility (83%, 100%) and suggestions for further study/investigation (83%, 100%). Group 2 identified 161 ‘HTA funded’ applications: 59 cited an external pilot/feasibility study where testing recruitment (50%, 73%) and feasibility (42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study where testing recruitment (93%, 100%) and feasibility (44%, 92%) were the most common study elements reported.

Conclusions ‘HTA funded’ research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.

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More information

Accepted/In Press date: 8 August 2018
e-pub ahead of print date: 25 September 2018

Identifiers

Local EPrints ID: 423749
URI: https://eprints.soton.ac.uk/id/eprint/423749
ISSN: 2044-6055
PURE UUID: 8a18afc5-241d-4409-bfce-4bb380ce5727
ORCID for Amanda Blatch-Jones: ORCID iD orcid.org/0000-0002-1486-5561
ORCID for Emma V Kirkpatrick: ORCID iD orcid.org/0000-0002-3099-1605

Catalogue record

Date deposited: 01 Oct 2018 16:30
Last modified: 14 Mar 2019 01:44

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