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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...

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Autores principales: Blatch-Jones, Amanda Jane, Pek, Wei, Kirkpatrick, Emma, Ashton-Key, Martin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6169762/
https://www.ncbi.nlm.nih.gov/pubmed/30257847
http://dx.doi.org/10.1136/bmjopen-2018-022233
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author Blatch-Jones, Amanda Jane
Pek, Wei
Kirkpatrick, Emma
Ashton-Key, Martin
author_facet Blatch-Jones, Amanda Jane
Pek, Wei
Kirkpatrick, Emma
Ashton-Key, Martin
author_sort Blatch-Jones, Amanda Jane
collection PubMed
description 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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spelling pubmed-61697622018-10-05 Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study Blatch-Jones, Amanda Jane Pek, Wei Kirkpatrick, Emma Ashton-Key, Martin BMJ Open Research Methods 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. BMJ Publishing Group 2018-09-25 /pmc/articles/PMC6169762/ /pubmed/30257847 http://dx.doi.org/10.1136/bmjopen-2018-022233 Text en © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Research Methods
Blatch-Jones, Amanda Jane
Pek, Wei
Kirkpatrick, Emma
Ashton-Key, Martin
Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study
title Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study
title_full Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study
title_fullStr Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study
title_full_unstemmed Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study
title_short Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study
title_sort role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study
topic Research Methods
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6169762/
https://www.ncbi.nlm.nih.gov/pubmed/30257847
http://dx.doi.org/10.1136/bmjopen-2018-022233
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