Evidence map›Paper›PMID 32252788›Full record

ArticleTrials2020

Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study.

Gareth Davies, Nicola Mills, Chris Holcombe, Shelley Potter, iBRA Steering Group

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.0field-weighted citation impact, top 24% of its field
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

7 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
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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

5 authors at 3 institutions in 1 country.

Gareth DaviesBristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Nicola MillsBristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Chris HolcombeLinda McCartney Centre, Royal Liverpool and Broadgreen University Hospital, Prescot Street, Liverpool, L7 8XP, UK.
Shelley PotterBristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. Shelley.Potter@bristol.ac.uk.ORCID http://orcid.org/0000-0002-6977-312X
iBRA Steering Group
North Bristol NHS Trust · GBUniversity of Bristol · GBRoyal Liverpool and Broadgreen University Hospital NHS Trust · GB

Funding

Association of Breast Surgery NADepartment of Health CS-2016-16-019Department of Health PB-PG-0214-33065Medical Research Council MR/K025643/1Research for Patient Benefit Programme PB-PG-0214-33065Research Trainees Coordinating Centre CS-2016-16-019
6 · The paper itself

Abstract

backgroundImplant-based breast reconstruction (IBBR) is the most commonly performed breast reconstruction technique worldwide but the technique is evolving rapidly. High-quality evidence is needed to support practice. Randomised controlled trials (RCTs) provide the best evidence but can be challenging to conduct. iBRA is a four-phased study which aimed to inform the feasibility, design and conduct of an RCT in IBBR. In phase 3, the randomisation acceptability study, an electronic survey and qualitative interviews were conducted to explore professionals' perceptions of future trials in IBBR. Findings from the interviews are presented here.

methodsSemi-structured qualitative interviews were undertaken with a purposive sample of 31 health professionals (HPs) who completed the survey to explore their attitudes to the feasibility of potential RCTs in more detail. All interviews were transcribed verbatim and data were analysed thematically using constant comparative techniques. Sampling, data collection and analysis were undertaken iteratively and concurrently until data saturation was achieved.

resultsAlmost all HPs acknowledged the need for better evidence to support the practice of IBBR and most identified RCTs as generating the highest-quality evidence. Despite highlighting potential challenges, most participants supported the need for an RCT in IBBR. A minority, however, were strongly opposed to a future trial. The opposition and challenges identified centred around three key themes; (i) limited understanding of pragmatic study design and the value of randomisation in minimising bias; (ii) clinician and patient equipoise and (iii) aspects of surgical culture and training that were not supportive of RCTs.

conclusionThere is a need for well-designed, large-scale RCTs to support the current practice of IBBR but barriers to their acceptability are evident. The perceived barriers to RCTs in breast reconstruction identified in this study are not insurmountable and have previously been overcome in other similar surgical trials. This may represent an opportunity, not only to establish the evidence base for IBBR, but also to improve engagement in RCTs in breast surgery in general to ultimately improve outcomes for patients.

trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN37664281.

Indexed as

Attitude of Health PersonnelHealth Knowledge, Attitudes, PracticePractice Patterns, Physicians'FemaleHumansInterviews as TopicMammaplastyPatient SelectionQualitative ResearchRandomized Controlled Trials as TopicSurveys and QuestionnairesImplant breast reconstructionQualitative, randomised controlled trialsSurgery

Identifiers

PMID32252788
PMCPMC7132957
OpenAlexW3009396542

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.