Evidence map›Paper›PMID 24850821›Full record

SynthesisBMJ (Clinical research ed.)2014

Use of placebo controls in the evaluation of surgery: systematic review.

Karolina Wartolowska, Andrew Judge, Sally Hopewell, Gary S Collins, Benjamin J F Dean, Ines Rombach, David Brindley, Julian Savulescu, David J Beard, Andrew J Carr

2 registry-linked trialsOpen access · hybridAbstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMJ (Clinical research ed.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 120 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
120citing papers in PubMed, 21 pooled it
18.0field-weighted citation impact, top 1% 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.

NCT03907982 nacompletednot on this mapstarted 2021, after this paper: background citation

Objective Randomised Blinded Investigation of Therapeutic Ablation Versus Cardioversion for Persistent Atrial Fibrillation

TypeinterventionalSponsorBarts & The London NHS TrustRan2021 to 2023Enrolled20ConditionsPersistent Atrial Fibrillation, Cardiac ArrhythmiaArmsDC Cardioversion, Pulmonary vein isolation, Implantable loop recorder
NCT06096246 narecruitingnot on this mapstarted 2024, after this paper: background citation

Objective Randomised Blinded Investigation of Cardioversion Versus Ablation for Persistent Atrial Fibrillation (ORBICA-AF)

TypeinterventionalSponsorBarts & The London NHS TrustRan2024 to 2027Enrolled208ConditionsPersistent Atrial Fibrillation, Cardiac Arrhythmia, Catheter AblationArmsPulmonary vein isolation, DC Cardioversion, Implantable loop recorder, Femoral sheath insertion
3 · Its place in the literature

Who cites it

120 citing papers in PubMed, 21 syntheses or guidelines pooled it, 267 citations in OpenAlex.

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  3. Surgical interventions for Ménière's disease.The Cochrane database of systematic reviews · 2023
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  14. Surgical options for lumbar spinal stenosis.The Cochrane database of systematic reviews · 2016
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  19. Systematic review of observational studies reveals no association between low back pain and lumbar spondylolysis with or without isthmic spondylolisthesis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2015
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60 more citing papers are in PubMed but not listed here.

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 at 4 institutions in 2 countries.

Karolina WartolowskaNational Institute of Health Research Musculoskeletal Biomedical Research Unit, Oxford, UK Botnar Institute of Musculoskeletal Sciences, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK karolina.wartolowska@ndorms.ox.ac.uk.
Andrew JudgeNational Institute of Health Research Musculoskeletal Biomedical Research Unit, Oxford, UK Botnar Institute of Musculoskeletal Sciences, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.
Sally HopewellBotnar Institute of Musculoskeletal Sciences, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
Gary S CollinsBotnar Institute of Musculoskeletal Sciences, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
Benjamin J F DeanNational Institute of Health Research Musculoskeletal Biomedical Research Unit, Oxford, UK Botnar Institute of Musculoskeletal Sciences, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK.
Ines RombachNational Institute of Health Research Musculoskeletal Biomedical Research Unit, Oxford, UK Botnar Institute of Musculoskeletal Sciences, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK.
David BrindleyNational Institute of Health Research Musculoskeletal Biomedical Research Unit, Oxford, UK Botnar Institute of Musculoskeletal Sciences, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK The Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation, University of Oxford, Oxford, UK Harvard Stem Cell Institute, Holyoke Centre, Cambridge, MA, USA.
Julian SavulescuOxford Uehiro Centre for Practical Ethics, University of Oxford, Oxford, UK.
David J BeardNational Institute of Health Research Musculoskeletal Biomedical Research Unit, Oxford, UK Botnar Institute of Musculoskeletal Sciences, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK Surgical Intervention Trials Unit (SITU), RCS Surgical Trials Unit, Botnar Institute of Musculoskeletal Sciences, Oxford, UK.
Andrew J CarrNational Institute of Health Research Musculoskeletal Biomedical Research Unit, Oxford, UK Botnar Institute of Musculoskeletal Sciences, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK Surgical Intervention Trials Unit (SITU), RCS Surgical Trials Unit, Botnar Institute of Musculoskeletal Sciences, Oxford, UK.
Nuffield Orthopaedic Centre · GBUniversity of Oxford · GBSouthampton General Hospital · GBWellcome Centre for Ethics and Humanities · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate whether placebo controls should be used in the evaluation of surgical interventions.

designSystematic review. DATA SOURCES: We searched Medline, Embase, and the Cochrane Controlled Trials Register from their inception to November 2013. STUDY SELECTION: Randomised clinical trials comparing any surgical intervention with placebo. Surgery was defined as any procedure that both changes the anatomy and requires a skin incision or use of endoscopic techniques. DATA EXTRACTION: Three reviewers (KW, BJFD, IR) independently identified the relevant trials and extracted data on study details, outcomes, and harms from included studies.

resultsIn 39 out of 53 (74%) trials there was improvement in the placebo arm and in 27 (51%) trials the effect of placebo did not differ from that of surgery. In 26 (49%) trials, surgery was superior to placebo but the magnitude of the effect of the surgical intervention over that of the placebo was generally small. Serious adverse events were reported in the placebo arm in 18 trials (34%) and in the surgical arm in 22 trials (41.5%); in four trials authors did not specify in which arm the events occurred. However, in many studies adverse events were unrelated to the intervention or associated with the severity of the condition. The existing placebo controlled trials investigated only less invasive procedures that did not involve laparotomy, thoracotomy, craniotomy, or extensive tissue dissection.

conclusionsPlacebo controlled trial is a powerful, feasible way of showing the efficacy of surgical procedures. The risks of adverse effects associated with the placebo are small. In half of the studies, the results provide evidence against continued use of the investigated surgical procedures. Without well designed placebo controlled trials of surgery, ineffective treatment may continue unchallenged.

Indexed as

PlacebosSurgical Procedures, OperativeHumansRandomized Controlled Trials as TopicPlacebos

Identifiers

PMID24850821
PMCPMC4029190
OpenAlexW2021953069

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.