Trial reportBehavioural neurology2019
Assessing Treatment Fidelity within an Epilepsy Randomized Controlled Trial: Seizure First Aid Training for People with Epilepsy Who Visit Emergency Departments.
Trial report in Behavioural neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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.
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.
Who cites it
2 citing papers in PubMed.
- Trial
- Decreasing Emergency Department Visits for Children With Epilepsy.Neurology. Clinical practice · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
purposeTo measure fidelity with which a group seizure first aid training intervention was delivered within a pilot randomized controlled trial underway in the UK for adults with epilepsy who visit emergency departments (ED) and informal carers. Estimates of its effects, including on ED use, will be produced by the trial. Whilst hardly ever reported for trials of epilepsy interventions-only one publication on this topic exists-this study provides the information on treatment fidelity necessary to allow the trial's estimates to be accurately interpreted. This rare worked example of how fidelity can be assessed could also provide guidance sought by neurology trialists on how to assess fidelity.
methods53 patients who had visited ED on ≥2 occasions in prior year were recruited for the trial; 26 were randomized to the intervention. 7 intervention courses were delivered for them by one facilitator. Using audio recordings, treatment "adherence" and "competence" were assessed. Adherence was assessed by a checklist of the items comprising the intervention. Using computer software, competence was measured by calculating facilitator speech during the intervention (didacticism). Interrater reliability was evaluated by two independent raters assessing each course using the measures and their ratings being compared.
resultsThe fidelity measures were found to be reliable. For the adherence instrument, raters agreed 96% of the time, PABAK-OS kappa 0.91. For didacticism, raters' scores had an intraclass coefficient of 0.96. In terms of treatment fidelity, not only were courses found to have been delivered with excellent adherence (88% of its items were fully delivered) but also as intended they were highly interactive, with the facilitator speaking for, on average, 55% of course time.
conclusionsThe fidelity measures used were reliable and showed that the intervention was delivered as attended. Therefore, any estimates of intervention effect will not be influenced by poor implementation fidelity.
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Registered trials
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