Evidence map›Paper›PMID 27008687›Full record

SynthesisBMJ open2016

Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review.

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

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 6 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

32 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. A systematic review of the methodological quality of randomised trials in IBD surgery.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2026
    Pooled it
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  5. Implanted spinal neuromodulation interventions for chronic pain in adults.The Cochrane database of systematic reviews · 2021
    Pooled it
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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

8 authors.

Karolina WartolowskaOxford NIHR Musculoskeletal Biomedical Research Unit, Oxford, UK Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Institute of Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Gary S CollinsNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Institute of Musculoskeletal Sciences, University of Oxford, Oxford, UK Centre for Statistics in Medicine, Oxford, UK.
Sally HopewellNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Institute of Musculoskeletal Sciences, University of Oxford, Oxford, UK Centre for Statistics in Medicine, Oxford, UK.
Andrew JudgeOxford NIHR Musculoskeletal Biomedical Research Unit, Oxford, UK Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Institute of Musculoskeletal Sciences, University of Oxford, Oxford, UK MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, UK.
Benjamin J F DeanOxford NIHR Musculoskeletal Biomedical Research Unit, Oxford, UK Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Institute of Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Ines RombachOxford NIHR Musculoskeletal Biomedical Research Unit, Oxford, UK Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Institute of Musculoskeletal Sciences, University of Oxford, Oxford, UK.
David J BeardOxford NIHR Musculoskeletal Biomedical Research Unit, Oxford, UK Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Institute of Musculoskeletal Sciences, University of Oxford, Oxford, UK Royal College of Surgeons of England Clinical Trials Unit, Botnar Institute of Musculoskeletal Sciences, Oxford, UK.
Andrew J CarrOxford NIHR Musculoskeletal Biomedical Research Unit, Oxford, UK Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Institute of Musculoskeletal Sciences, University of Oxford, Oxford, UK Royal College of Surgeons of England Clinical Trials Unit, Botnar Institute of Musculoskeletal Sciences, Oxford, UK.

Funding

Medical Research Council MC_PC_12020Medical Research Council MC_PC_14103
6 · The paper itself

Abstract

objectivesTo find evidence, either corroborating or refuting, for many persisting beliefs regarding the feasibility of carrying out surgical randomised controlled trials with a placebo arm, with emphasis on the challenges related to recruitment, funding, anaesthesia or blinding.

designSystematic review. DATA SOURCES AND STUDY SELECTION: The analysis involved studies published between 1959 and 2014 that were identified during an earlier systematic review of benefits and harms of placebo-controlled surgical trials published in 2014.

results63 trials were included in the review. The main problem reported in many trials was a very slow recruitment rate, mainly due to the difficulty in finding eligible patients. Existing placebo trials were funded equally often from commercial and non-commercial sources. General anaesthesia or sedation was used in 41% of studies. Among the reviewed trials, 81% were double-blinded, and 19% were single-blinded. Across the reviewed trials, 96% (range 50-100%) of randomised patients completed the study. The withdrawal rate during the study was similar in the surgical and in the placebo groups.

conclusionsThis review demonstrated that placebo-controlled surgical trials are feasible, at least for procedures with a lower level of invasiveness, but also that recruitment is difficult. Many of the presumed challenges to undertaking such trials, for example, funding, anaesthesia or blinding of patients and assessors, were not reported as obstacles to completion in any of the reviewed trials.

Indexed as

Anesthesia, GeneralSurgical Procedures, OperativeFeasibility StudiesHumansPlacebosRandomized Controlled Trials as TopicPlacebosPlacebosRandomised Controlled TrialsSURGERY

Identifiers

PMID27008687
PMCPMC4800115

What OpenQuestion holds

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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.