Evidence map›Paper›PMID 26337522›Full record

ReviewTrials2015

Interventions in randomised controlled trials in surgery: issues to consider during trial design.

Natalie S Blencowe, Julia M Brown, Jonathan A Cook, Chris Metcalfe, Dion G Morton, Jon Nicholl, Linda D Sharples, Shaun Treweek, Jane M Blazeby, Members of the MRC Hub for Trials Methodology Research Network Workshop

Abstract readReview
In one paragraph

Review in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 8 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

22 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  6. Interventions for necrotizing soft tissue infections in adults.The Cochrane database of systematic reviews · 2018
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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

10 authors.

Natalie S BlencoweCentre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. natalie.blencowe@bristol.ac.uk.
Julia M BrownLeeds Institute for Clinical Trials Research, University of Leeds, Clarendon Road, Leeds, UK. j.m.b.brown@leeds.ac.uk.
Jonathan A CookCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. jonathan.cook@ndorms.ox.ac.uk.
Chris MetcalfeCentre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. chris.metcalfe@bristol.ac.uk.
Dion G MortonAcademic Department of Surgery, School of Cancer Sciences, Queen Elizabeth Hospital University of Birmingham, Edgbaston, Birmingham, UK. dion.morton@uhb.nhs.uk.
Jon NichollSchool of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, UK. j.nicholl@sheffield.ac.uk.
Linda D SharplesLeeds Institute for Clinical Trials Research, University of Leeds, Clarendon Road, Leeds, UK. l.sharples@leeds.ac.uk.
Shaun TreweekHealth Services Research Unit, University of Aberdeen, 3rd Floor, Health Sciences Building, Foresterhill, Aberdeen, UK. streweek@mac.com.
Jane M BlazebyCentre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. j.m.blazeby@bristol.ac.uk.
Members of the MRC Hub for Trials Methodology Research Network Workshop

Funding

Cancer Research UK 16893Chief Scientist Office HSRU1Department of Health DRF-2011-04-016Department of Health PB-PG-0214-33065Medical Research Council G1002292Medical Research Council MC_U105232027Medical Research Council MC_U122886349Medical Research Council MC_UU_12023/14Medical Research Council MR/K025635/1Medical Research Council MR/K025643/1Medical Research Council MR/L004933/1Medical Research Council MR/L004933/1-R/N29
6 · The paper itself

Abstract

Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.

Indexed as

Research DesignSurgical Procedures, OperativeHumansRandomized Controlled Trials as TopicTreatment Outcome

Identifiers

PMID26337522
PMCPMC4558964

What OpenQuestion holds

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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.