Evidence map›Paper›PMID 31074503›Full record

ReviewThe British journal of surgery2019

Value of surgical pilot and feasibility study protocols.

K Fairhurst, J M Blazeby, S Potter, C Gamble, C Rowlands, K N L Avery

Abstract readReview
In one paragraph

Review in The British journal of surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  8. AMPDECIDE amputation level patient decision aids: a feasibility study.BMC medical informatics and decision making · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

K FairhurstCentre for Surgical Research and Medical Research Council (MRC) ConDuCT-II Hub for Trials Methodology Research, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0001-9838-4978
J M BlazebyCentre for Surgical Research and Medical Research Council (MRC) ConDuCT-II Hub for Trials Methodology Research, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-3354-3330
S PotterCentre for Surgical Research and Medical Research Council (MRC) ConDuCT-II Hub for Trials Methodology Research, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-6977-312X
C GambleMRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.
C RowlandsCentre for Surgical Research and Medical Research Council (MRC) ConDuCT-II Hub for Trials Methodology Research, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
K N L AveryCentre for Surgical Research and Medical Research Council (MRC) ConDuCT-II Hub for Trials Methodology Research, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Funding

Department of Health CS-2016-16-019Medical Research Council MR/K025643/1Medical Research Council MR/L004933/1Medical Research Council MR/L004933/2
6 · The paper itself

Abstract

backgroundRCTs 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.

methodsPFS 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.

resultsThirty-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.

conclusionThe full potential of pretrial work to inform and optimize definitive surgical studies is not being realized.

Indexed as

Feasibility StudiesPilot ProjectsSurgical Procedures, OperativeClinical Trials as TopicHumansPatient SelectionRandomized Controlled Trials as TopicResearch DesignUnited Kingdom

Identifiers

PMID31074503
PMCPMC6618315

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.