Evidence map›Paper›PMID 28253897›Full record

Trial reportTrials2017

Promoting Recruitment using Information Management Efficiently (PRIME): statistical analysis plan for a stepped wedge cluster randomised trial within the REstart or STop Antithrombotics Randomised Trial (RESTART).

Richard A Parker, Christopher J Weir, Amy E Maxwell, Rustam Al-Shahi Salman

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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

4 authors.

Richard A ParkerEdinburgh Clinical Trials Unit and Centre for Population Health Sciences, Usher Institute of Population Health Sciences and Informatics, Old Medical School, Teviot Place, Edinburgh, UK. Richard.Parker@ed.ac.uk.
Christopher J WeirEdinburgh Clinical Trials Unit and Centre for Population Health Sciences, Usher Institute of Population Health Sciences and Informatics, Old Medical School, Teviot Place, Edinburgh, UK.
Amy E MaxwellCentre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
Rustam Al-Shahi SalmanCentre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.

Funding

British Heart Foundation PG/14/50/30891British Heart Foundation SP/12/2/29422Medical Research Council G1002605
6 · The paper itself

Abstract

backgroundPromoting Recruitment using Information Management Efficiently (PRIME) is a stepped wedge, cluster randomised trial-within-a-trial of a complex intervention to help sites in the United Kingdom to attain their own target number of participants to recruit to the REstart or STop Antithrombotics Randomised Trial (RESTART, ISRCTN71907627).

methodsSeventy-two hospital sites had opted into PRIME and were randomly allocated (using a computer-generated block randomisation algorithm, stratified by hospital location) to one of 12 months in which a complex intervention would be delivered. All sites began in the control state. The primary outcome is the total number of patients randomised into RESTART per month per site, which will be analysed in a negative binomial generalised linear mixed model. Secondary outcomes include the proportion of sites using stroke databases to identify potentially eligible patients before PRIME, frequency of using bespoke stroke audit data exports during PRIME, barriers to recruitment in PRIME, barriers to using the bespoke stroke audit data exports, and disadvantages of the bespoke stroke audit exports identified by PRIME sites. PRIME began in September 2015. The last intervention will be delivered in August 2016. Six-month follow-up will be complete in February 2017. This statistical analysis plan was written and submitted for publication before all sites received the PRIME intervention and before outcome data were known. DISCUSSION: Final results of PRIME will be analysed and disseminated in 2017.

trial registrationNorthern Ireland Hub for Trials Methodology Research SWAT repository (SWAT22).

Indexed as

Electronic Health RecordsInformation ManagementPatient SelectionCerebral HemorrhageClinical ProtocolsData Interpretation, StatisticalDrug Administration ScheduleFibrinolytic AgentsHumansModels, StatisticalPlatelet Aggregation InhibitorsRecurrenceRisk FactorsSample SizeSecondary PreventionStrokeFibrinolytic AgentsPlatelet Aggregation InhibitorsCluster randomised trialComplex interventionRecruitmentStatistical analysis planStepped wedge trialStudy-within-a-trialTrial-within-a-trial

Identifiers

PMID28253897
PMCPMC5335848

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.