Evidence map›Paper›PMID 28915851›Full record

SynthesisBMC medical research methodology2017

Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review.

Stephanie Armstrong, Adele Langlois, Despina Laparidou, Mark Dixon, Jason P Appleton, Philip M Bath, Helen Snooks, A Niroshan Siriwardena

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

Synthesis in BMC medical research methodology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. A systematic review of ambulance service-based randomised controlled trials in stroke.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023
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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.

Stephanie ArmstrongCommunity and Health Research Unit, College of Social Science, University of Lincoln, Brayford Pool, Lincoln, LN6 7TS, UK. sarmstrong@lincoln.ac.uk.ORCID http://orcid.org/0000-0002-2599-4844
Adele LangloisSchool of Social and Political Sciences, College of Social Science, University of Lincoln, Brayford Pool, Lincoln, LN6 7TS, UK.
Despina LaparidouCommunity and Health Research Unit, College of Social Science, University of Lincoln, Brayford Pool, Lincoln, LN6 7TS, UK.
Mark DixonStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Jason P AppletonStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Philip M BathStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Helen SnooksMedical School, Grove Building, Swansea University, Singleton Park, Swansea, UK.
A Niroshan SiriwardenaCommunity and Health Research Unit, College of Social Science, University of Lincoln, Brayford Pool, Lincoln, LN6 7TS, UK.

Funding

British Heart Foundation CS/14/4/30972Wellcome Trust
6 · The paper itself

Abstract

backgroundWe sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting.

methodsA systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis.

resultsIn all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent.

conclusionsConsent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

Indexed as

AmbulancesEmergency Medical ServicesEmergency MedicineHumansInformed ConsentRandomized Controlled Trials as TopicAmbulanceClinical trialsConsentEthicsPrehospital

Identifiers

PMID28915851
PMCPMC5603026

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.