Evidence map›Paper›PMID 28424796›Full record

ArticleContemporary clinical trials communications2017

External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial.

Sheila M Bird, John Strang, Deborah Ashby, John Podmore, J Roy Robertson, Sarah Welch, Angela M Meade, Mahesh K B Parmar

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

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

  1. Pooled it
  2. Trial
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.

Sheila M BirdMRC Biostatistics Unit, Cambridge CB2 0SR, UK.
John StrangNational Addiction Centre, King's College London, London SE5 8BB, UK.
Deborah AshbyImperial Clinical Trials Unit School of Public Health, London W12 7RH, UK.
John PodmoreDurham University School of Applied Social Sciences, Durham DH1 3LE, UK.
J Roy RobertsonEdinburgh University Usher Institute of Population Health Sciences and Informatics, Edinburgh EH16 4UX, UK.
Sarah WelchTurning Point, Gloucester GL1 2HT, UK.
Angela M MeadeMRC Clinical Trials Unit at University College London, London WC2B 6NH, UK.
Mahesh K B ParmarMRC Clinical Trials Unit at University College London, London WC2B 6NH, UK.

Funding

Medical Research Council MC_EX_G0800012Medical Research Council MC_U105260794Medical Research Council MC_UU_12023/30
6 · The paper itself

Abstract

The prison-based N-ALIVE pilot trial had undertaken to notify the Research Ethics Committee and participants if we had reason to believe that the N-ALIVE pilot trial would not proceed to the main trial. In this paper, we describe how external data for the third year of before/after evaluation from Scotland's National Naloxone Programme, a related public health policy, were anticipated by eliciting prior opinion about the Scottish results in the month prior to their release as official statistics. We summarise how deliberations by the N-ALIVE Trial Steering-Data Monitoring Committee (TS-DMC) on N-ALIVE's own interim data, together with those on naloxone-on-release (NOR) from Scotland, led to the decision to cease randomization in the N-ALIVE pilot trial and recommend to local Principal Investigators that NOR be offered to already-randomized prisoners who had not yet been released.

Indexed as

CausalityCessationData Monitoring CommitteeElicitationExternal evidenceRandomized pilot trial

Identifiers

PMID28424796
PMCPMC5389338

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.