Defining feasibility and pilot studies in preparation for randomised controlled trials: using consensus methods and validation to develop a conceptual framework

Eldridge, Sandra; Bond, Christine; Campbell, Mike; Hopewell, Sally; Thabane, Lehana; Lancaster, Gill; Coleman, Claire L.

doi:10.1186/1745-6215-16-s2-o87

Cited by 13 publications

(16 citation statements)

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“…Previous guidance regarding the optimal design and conduct of PFS has been theoretical or generic. The IDEAL framework, for example, describes a pathway for new surgical interventions from first in man (stage 1) to long‐term study (stage 4), with stage 2a (development) and 2b (exploration) studies considered to be PFS, focusing on addressing uncertainties before stage 3 assessment in a definitive RCT.…”

Section: Discussionmentioning

confidence: 99%

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Value of surgical pilot and feasibility study protocols

Fairhurst

Blazeby

Potter

et al. 2019

British Journal of Surgery

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Background RCTs in surgery are challenging owing to well established methodological issues. Well designed pilot and feasibility studies (PFS) may help overcome such issues to inform successful main trial design and conduct. This study aimed to analyse protocols of UK‐funded studies to explore current use of PFS in surgery and identify areas for practice improvement. Methods PFS of surgical interventions funded by UK National Institute for Health Research programmes from 2005 to 2015 were identified, and original study protocols and associated publications sourced. Data extracted included study design characteristics, reasons for performing the work including perceived uncertainties around conducting a definitive main trial, and whether the studies had been published. Results Thirty‐five surgical studies were identified, of which 29 were randomized, and over half (15 of 29) included additional methodological components (such as qualitative work examining recruitment, and participant surveys studying current interventions). Most studies focused on uncertainties around recruitment (32 of 35), with far fewer tackling uncertainties specific to surgery, such as intervention stability, implementation or delivery (10 of 35). Only half (19 of 35) had made their results available publicly, to date. Conclusion The full potential of pretrial work to inform and optimize definitive surgical studies is not being realized.

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Section: Discussionmentioning

confidence: 99%

“…Well designed pilot and feasibility studies (PFS) may help to overcome challenges associated with undertaking RCTs in surgery, by allowing uncertainties to be addressed, and optimal design of the main trial to be determined. Previous methodological work has considered the use and misuse of PFS in general.…”

Section: Introductionmentioning

confidence: 99%

Value of surgical pilot and feasibility study protocols

Fairhurst

Blazeby

Potter

et al. 2019

British Journal of Surgery

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“…For these reasons, feasibility or pilot studies can be useful as preliminary studies to assist the design of larger trials. Eldridge et al (2015) defined a conceptual framework for feasibility and pilot trials [14]. As explained by Marsaux et al (2017), a feasibility study assesses if research or activity can be done, should be done, and if so, how [15].…”

Section: Introductionmentioning

confidence: 99%

A Dietary Intervention of Bioactive Enriched Foods Aimed at Adults at Risk of Metabolic Syndrome: Protocol and Results from PATHWAY-27 Pilot Study

et al. 2019

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Around a quarter of the global adult population have metabolic syndrome (MetS) and therefore increased risk of cardiovascular mortality and diabetes. Docosahexaenoic acid, oat beta-glucan and grape anthocyanins have been shown to be effective in reducing MetS risk factors when administered as isolated compounds, but their effect when administered as bioactive-enriched foods has not been evaluated. Objective: The overall aim of the PATHWAY-27 project was to evaluate the effectiveness of bioactive-enriched food consumption on improving risk factors of MetS. A pilot study was conducted to assess which of five bioactive combinations provided within three different food matrices (bakery, dairy or egg) were the most effective in adult volunteers. The trial also evaluated the feasibility of production, consumer acceptability and gastrointestinal tolerance of the bioactive-enriched food. Method: The study included three monocentric, parallel-arm, double-blind, randomised, dietary intervention trials without a placebo. Each recruiting centre tested the five bioactive combinations within a single food matrix. Results: The study was completed by 167 participants (74 male, 93 female). The results indicated that specific bioactive/matrix combinations have effects on serum triglyceride or HDL-cholesterol level without adverse effects. Conclusion: The study evidenced that bioactive-enriched food offers a promising food-based strategy for MetS prevention, and highlighted the importance of conducting pilot studies.

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“…We need to work harder to be more patient centred in research as well as care. We need to adopt the frameworks and approaches from implementation science, undertake appropriate pilot and feasibility work when building a meaningful programme of research and when reporting studies make better use of resources such as the portfolio of reporting checklists on the Equator network…”

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confidence: 99%