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

ABSTRACT: The 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.This 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.A 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.In 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.

SUBMITTER: Meurer WJ

PROVIDER: S-EPMC4363089 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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

Meurer William J WJ Silbergleit Robert R Nicholas Katherine S KS Burke James F JF Durkalski Valerie V

Academic emergency medicine : official journal of the Society for Academic Emergency Medicine 20150225 3

<h4>Objectives</h4>The 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.<h4>Methods</h4>This 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 l ...[more]

PMID: 25715865

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Project description:BACKGROUND:The choice of drugs for patients with status epilepticus that is refractory to treatment with benzodiazepines has not been thoroughly studied. METHODS:In a randomized, blinded, adaptive trial, we compared the efficacy and safety of three intravenous anticonvulsive agents - levetiracetam, fosphenytoin, and valproate - in children and adults with convulsive status epilepticus that was unresponsive to treatment with benzodiazepines. The primary outcome was absence of clinically evident seizures and improvement in the level of consciousness by 60 minutes after the start of drug infusion, without additional anticonvulsant medication. The posterior probabilities that each drug was the most or least effective were calculated. Safety outcomes included life-threatening hypotension or cardiac arrhythmia, endotracheal intubation, seizure recurrence, and death. RESULTS:A total of 384 patients were enrolled and randomly assigned to receive levetiracetam (145 patients), fosphenytoin (118), or valproate (121). Reenrollment of patients with a second episode of status epilepticus accounted for 16 additional instances of randomization. In accordance with a prespecified stopping rule for futility of finding one drug to be superior or inferior, a planned interim analysis led to the trial being stopped. Of the enrolled patients, 10% were determined to have had psychogenic seizures. The primary outcome of cessation of status epilepticus and improvement in the level of consciousness at 60 minutes occurred in 68 patients assigned to levetiracetam (47%; 95% credible interval, 39 to 55), 53 patients assigned to fosphenytoin (45%; 95% credible interval, 36 to 54), and 56 patients assigned to valproate (46%; 95% credible interval, 38 to 55). The posterior probability that each drug was the most effective was 0.41, 0.24, and 0.35, respectively. Numerically more episodes of hypotension and intubation occurred in the fosphenytoin group and more deaths occurred in the levetiracetam group than in the other groups, but these differences were not significant. CONCLUSIONS:In the context of benzodiazepine-refractory convulsive status epilepticus, the anticonvulsant drugs levetiracetam, fosphenytoin, and valproate each led to seizure cessation and improved alertness by 60 minutes in approximately half the patients, and the three drugs were associated with similar incidences of adverse events. (Funded by the National Institute of Neurological Disorders and Stroke; ESETT ClinicalTrials.gov number, NCT01960075.).

Project description:Patients who use an emergency department (ED) for acute migraine headaches have higher migraine disability scores, lower socioeconomic status, and are unlikely to have used a migraine-specific medication prior to presentation to the ED. The objective was to determine if a comprehensive migraine intervention, delivered just prior to ED discharge, could improve migraine impact scores 1?month after the ED visit.? This was a randomized controlled trial of a comprehensive migraine intervention versus typical care among patients who presented to an ED for management of acute migraine. At the time of discharge, for patients randomized to comprehensive care, the research team reinforced their diagnosis, shared a migraine education presentation from the National Library of Medicine, provided them with six tablets of sumatriptan 100?mg and 14 tablets of naproxen 500?mg, and if they wished, provided them with an expedited free appointment to the institution's headache clinic. Patients randomized to typical care received the care their attending emergency physicians (EPs) felt was appropriate. The primary outcome was a between-group comparison of the Headache Impact Test (HIT-6) score, a validated headache assessment instrument, 1?month after ED discharge. Secondary outcomes included an assessment of satisfaction with headache care and use of migraine-specific medication within that 1-month period.? Over a 19-month period, 50 migraine patients were enrolled. One-month follow-up was successfully obtained in 92% of patients. Baseline characteristics were comparable. One-month HIT-6 scores in the two groups were nearly identical (59 vs. 56, 95% confidence interval [CI] for difference of 3?=?-5 to 11), as was dissatisfaction with overall headache care (17% vs. 18%, 95% CI for difference of 1%?=?-22% to 24%). Patients randomized to the comprehensive intervention were more likely to be using triptans or migraine-specific therapy (43% vs. 0%, 95% CI for difference of 43%?=?20 to 63%) 1?month later.A comprehensive migraine intervention, when compared to typical care, did not improve HIT-6 scores (a validated measure of the effect of migraine on one's daily life) 1?month after ED discharge. Future work is needed to define a migraine intervention that is practical and useful in an ED, where many underserved patients, of necessity, present for care.

Project description:BackgroundIn German emergency rescue services, inhalation treatment is routinely carried out by qualified health personnel. Standard operating procedures (SOP) for nebulization are neither uniform throughout Germany nor available in all federal states. Standardized recommendations with respect to which nebulizer type should be used are missing. The aerosol output as well as the drug deposition rates of jet and mesh nebulizers, however, differ considerably. Mesh devices can achieve a threefold higher lung deposition. Their use in emergency departments has also been shown to be associated with a better patient outcome when compared to jet nebulizers.ObjectiveThis survey was designed to evaluate the type of nebulizer used in the south German rescue services. Special attention was paid to the influence of existing SOP on the decision to perform nebulization during emergency treatment.Material and methodsA total of 4800 emergency paramedics working in Baden-Württemberg, Bavaria and Rhineland-Palatinate received a questionnaire with a total of 17 questions on the implementation of drug nebulization in the daily practice.ResultsDespite the existence of more efficient nebulizer types, the jet nebulizer was by far the most frequently used nebulizer in the south German rescue services. The deposition rates of both the jet and mesh nebulizers were considerably overestimated by most respondents; however, 77.5% of all respondents could not give any information about the deposition rates of the mesh nebulizer. Only two thirds of all respondents carried out nebulization treatment on the basis of SOP. The implementation of SOP, however, was pivotal to the application of nebulization during emergencies. If SOP were in place,76.9% of the responders used aerosol treatment compared to 23.1% when there were none. The perceived safety when using nebulization during emergencies was also significantly higher (p = 0.013) when SOP were implemented.ConclusionThe exclusive use of mesh nebulizers could standardize the treatment of emergency patients in the south German rescue services. The use of mesh devices might possibly improve patient outcomes, even if clinical studies are still lacking. Nebulizer treatment differs between the federal states. A comprehensive implementation of SOP for nebulization treatment might support this process and could increase the application frequency and the perceived safety of nebulization during emergencies. A better training of paramedic personnel could improve the knowledge of aerosols as a treatment option for emergency patients and help to classify the advantages and disadvantages of the different aerosol generators available.

Dataset Information

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

Publications

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

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