Evidence map›Paper›PMID 26336099›Full record

SynthesisBMC research notes2015

Non-compliance with randomised allocation and missing outcome data in randomised controlled trials evaluating surgical interventions: a systematic review.

Temitope E Adewuyi, Graeme MacLennan, Jonathan A Cook

Abstract readSystematic Review
In one paragraph

Synthesis in BMC research notes, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
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

3 authors.

Temitope E AdewuyiHealth Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, Scotland, UK. t.e.adewuyi.15@aberdeen.ac.uk.
Graeme MacLennanHealth Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, Scotland, UK. g.maclennan@abdn.ac.uk.
Jonathan A CookHealth Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, Scotland, UK. jonathan.cook@ndorms.ox.ac.uk.

Funding

Chief Scientist OfficeMedical Research Council G0601938Medical Research Council G1002292
6 · The paper itself

Abstract

backgroundRandomised controlled trials are widely acknowledged as the gold standard in medical research although their validity can be undermined by non-compliance with the randomly allocated treatment and missing data. Due to the nature of the intervention, surgical trials face particular threat to compliance and data collection. For example, ineligibility for the intervention may only become apparent once the operation has commenced. It is unclear how such cases are reported and handled.

objectiveThe objective was to assess non-compliance and missing data in reports of trials of surgical interventions.

methodsSearches for reports of trials involving at least one surgical procedure and published in 2010 were carried out in the Medical Literature Analysis and Retrieval System Online (MEDLINE(®)). Data on missing data, non-compliance and methods of handling missing data were extracted from full texts. Descriptive data analyses were carried out on the data.

resultsForty-five (55%) studies reported non-compliance with treatment allocation and 52 (63%) reported primary outcome missing data. The median levels of non-compliance and missing data were 2% [IQR (0, 5), range (0-29)] and 6% [IQR (0, 15), range (0-57)], respectively. Fifty-two (63%) studies analysed as randomised, 17 (21%) analysed per protocol and 3 (4%) analysed as treated. Complete case analysis was the most common method used to deal with missing data, 35/52 (67%).

conclusionsThe reporting of non-compliance to allocation and the handling of missing data were typically suboptimal. There is still room for improvement on the use of the CONSORT statement particularly in accounting for study participants. Transparency in reporting would facilitate evidence synthesis.

Indexed as

HumansOutcome Assessment, Health CarePatient ComplianceRandom AllocationRandomized Controlled Trials as TopicResearch DesignSurgical Procedures, Operative

Identifiers

PMID26336099
PMCPMC4558937

What OpenQuestion holds

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Registered trials

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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.