Evidence map›Paper›PMID 25715865›Full record

Trial reportAcademic emergency medicine : official journal of the Society for Academic Emergency Medicine2015

Accounting for repeat enrollments during an emergency clinical trial: the Rapid Anticonvulsant Medications Prior to Arrival Trial (RAMPART).

William J Meurer, Robert Silbergleit, Katherine S Nicholas, James F Burke, Valerie Durkalski

Open access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 34% of its field
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

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

William J MeurerThe Department of Emergency Medicine, University of Michigan, Ann Arbor, MI; The Department of Neurology, University of Michigan, Ann Arbor, MI.
Robert Silbergleit
Katherine S Nicholas
James F Burke
Valerie Durkalski
University of Michigan–Ann Arbor · USMedical University of South Carolina · US

Funding

Neurologic Emergencies Treatment Trials Network: Clinical Coordinating CenterU01NS056975 · NINDS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BARSAN, WILLIAM G · 2006 to 2015
$40.4M
Neurological Emergencies Treatment Trials Network Statistical and Data ManagementU01NS059041 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI DURKALSKI, VALERIE L, PALESCH, YUKO Y · 2006 to 2015
$9.1M
Using Outcomes Analyses to Inform Implementation of NINDS Clinical TrialsK08NS082597 · NINDS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BURKE, JAMES FRANCIS · 2013 to 2017
$948k
NINDS NIH HHS K08 NS082597NINDS NIH HHS L30 NS089043NINDS NIH HHS U01 NS056975NINDS NIH HHS U01NS056975NINDS NIH HHS U01 NS059041NINDS NIH HHS U01NS059041
6 · The paper itself

Abstract

objectivesThe objectives were to describe the frequency of repeat enrollment within a specific exception from informed consent trial testing benzodiazepine treatment of prehospital status epilepticus and to estimate the effect of repeat enrollments on the analysis of the primary outcome.

methodsThis was a secondary analysis of data collected as part of the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), a study comparing intramuscular midazolam to intravenous lorazepam given by paramedics to patients with prehospital status epilepticus. Subjects in RAMPART achieved a successful primary outcome if they had cessation of seizures by the time of emergency department arrival. Data were collected on all subjects, but only the first enrollment for each individual was used in the primary analysis. The patterns of repeat enrollment are described, along with the demographics of these subjects. In addition, an intraclass correlation coefficient (ICC) was estimated to assess the amount of within-subject correlation and its effect on the estimated treatment effect when all enrollments are included in the analysis.

resultsA total of 1,023 enrollments occurred in RAMPART among 893 unique individuals (range of repeat enrollment observed = two to 14). The ICC for seizure cessation within individual was low at 0.119; when excluding subjects with benzodiazepine crossover, the ICC was 0.094.

conclusionsIn clinical trials of emergency conditions with interval complete resolution, accounting for repeat enrollments is feasible. The RAMPART experience demonstrated that in this setting the within-subject correlation is low and can be accounted for at relatively low statistical cost.

Indexed as

Allied Health PersonnelResearch DesignAdultAgedAnticonvulsantsDouble-Blind MethodFemaleHumansInjections, IntramuscularInjections, IntravenousLorazepamMaleMidazolamMiddle AgedRacial GroupsStatus EpilepticusAnticonvulsantsLorazepamMidazolam

Identifiers

PMID25715865
PMCPMC4363089
OpenAlexW2158972076

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.