scholarly journals Seizure First Aid Training For people with Epilepsy (SAFE) frequently attending emergency departments and their significant others: results of a UK multi-centre randomised controlled pilot trial

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e035516
Author(s):  
Adam J Noble ◽  
Dee Snape ◽  
Sarah Nevitt ◽  
Emily A Holmes ◽  
Myfanwy Morgan ◽  
...  
Keyword(s):  
Emergency Departments ◽  
Pilot Trial ◽  
Routine Data ◽  
Significant Others ◽  
First Aid ◽  
Data Availability ◽  
Self Report ◽  
Intervention Cost ◽  
First Aid Training ◽  
Randomised Controlled

ObjectiveTo determine the feasibility and optimal design of a randomised controlled trial (RCT) of Seizure First Aid Training For Epilepsy (SAFE).DesignPilot RCT with embedded microcosting.SettingThree English hospital emergency departments (EDs).ParticipantsPatients aged ≥16 with established epilepsy reporting ≥2 ED visits in the prior 12 months and their significant others (SOs).InterventionsPatients (and their SOs) were randomly allocated (1:1) to SAFE plus treatment-as-usual (TAU) or TAU alone. SAFE is a 4-hour group course.Main outcome measuresTwo criteria evaluated a definitive RCT’s feasibility: (1) ≥20% of eligible patients needed to be consented into the pilot trial; (2) routine data on use of ED over the 12 months postrandomisation needed securing for ≥75%. Other measures included eligibility, ease of obtaining routine data, availability of self-report ED data and comparability, SAFE’s effect and intervention cost.ResultsOf ED attendees with a suspected seizure, 424 (10.6%) patients were eligible; 53 (12.5%) patients and 38 SOs consented. Fifty-one patients (and 37 SOs) were randomised. Routine data on ED use at 12 months were secured for 94.1% patients. Self-report ED data were available for 66.7% patients. Patients reported more visits compared with routine data. Most (76.9%) patients randomised to SAFE received it and no related serious adverse events occurred. ED use at 12 months was lower in the SAFE+TAU arm compared with TAU alone, but not significantly (rate ratio=0.62, 95% CI 0.33 to 1.17). A definitive trial would need ~674 patient participants and ~39 recruitment sites. Obtaining routine data was challenging, taking ~8.5 months.ConclusionsIn satisfying only one predetermined ‘stop/go’ criterion, a definitive RCT is not feasible. The low consent rate in the pilot trial raises concerns about a definitive trial’s finding’s external validity and means it would be expensive to conduct. Research is required into how to optimise recruitment from the target population.Trial registration numberISRCTN13871327

scholarly journals Seizure first aid training for people with epilepsy attending emergency departments and their significant others: the SAFE intervention and feasibility RCT

2020 ◽  
Vol 8 (39) ◽  
pp. 1-190 ◽  
Author(s):  
Adam Noble ◽  
Sarah Nevitt ◽  
Emily Holmes ◽  
Leone Ridsdale ◽  
Myfanwy Morgan ◽  
...  
Keyword(s):  
Emergency Department ◽  
Randomised Controlled Trial ◽  
Emergency Departments ◽  
Controlled Trial ◽  
Routine Data ◽  
Significant Others ◽  
Emergency Department Use ◽  
Treatment As Usual ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Background No seizure first aid training intervention exists for people with epilepsy who regularly attend emergency departments and their significant others, despite such an intervention’s potential to reduce clinically unnecessary and costly visits. Objectives The objectives were to (1) develop Seizure first Aid training For Epilepsy (SAFE) by adapting a broader intervention and (2) determine the feasibility and optimal design of a definitive randomised controlled trial to test SAFE’s efficacy. Design The study involved (1) the development of an intervention informed by a co-design approach with qualitative feedback and (2) a pilot randomised controlled trial with follow-ups at 3, 6 and 12 months and assessments of treatment fidelity and the cost of SAFE’s delivery. Setting The setting was (1) third-sector patient support groups and professional health-care organisations and (2) three NHS emergency departments in England. Participants Participants were (1) people with epilepsy who had visited emergency departments in the prior 2 years, their significant others and emergency department, paramedic, general practice, commissioning, neurology and nursing representatives and (2) people with epilepsy aged ≥ 16 years who had been diagnosed for ≥ 1 year and who had made two or more emergency department visits in the prior 12 months, and one of their significant others. Emergency departments identified ostensibly eligible people with epilepsy from attendance records and patients confirmed their eligibility. Interventions Participants in the pilot randomised controlled trial were randomly allocated 1 : 1 to SAFE plus treatment as usual or to treatment as usual only. Main outcome measures Consent rate and availability of routine data on emergency department use at 12 months were the main outcome measures. Other measures of interest included eligibility rate, ease with which people with epilepsy could be identified and routine data secured, availability of self-reported emergency department data, self-reported emergency department data’s comparability with routine data, SAFE’s effect on emergency department use, and emergency department use in the treatment as usual arm, which could be used in sample size calculations. Results (1) Nine health-care professionals and 23 service users provided feedback that generated an intervention considered to be NHS feasible and well positioned to achieve its purpose. (2) The consent rate was 12.5%, with 53 people with epilepsy and 38 significant others recruited. The eligibility rate was 10.6%. Identifying people with epilepsy from attendance records was resource intensive for emergency department staff. Those recruited felt more stigmatised because of epilepsy than the wider epilepsy population. Routine data on emergency department use at 12 months were secured for 94.1% of people with epilepsy, but the application process took 8.5 months. Self-reported emergency department data were available for 66.7% of people with epilepsy, and people with epilepsy self-reported more emergency department visits than were captured in routine data. Most participants (76.9%) randomised to SAFE received the intervention. The intervention was delivered with high fidelity. No related serious adverse events occurred. Emergency department use at 12 months was lower in the SAFE plus treatment as usual arm than in the treatment as usual only arm, but not significantly so. Calculations indicated that a definitive trial would need ≈ 674 people with epilepsy and ≈ 39 emergency department sites. Limitations Contrary to patient statements on recruitment, routine data secured at the pilot trial’s end indicated that ≈ 40% may not have satisfied the inclusion criterion of two or more emergency department visits. Conclusions An intervention was successfully developed, a pilot randomised controlled trial conducted and outcome data secured for most participants. The consent rate did not satisfy a predetermined ‘stop/go’ level of ≥ 20%. The time that emergency department staff needed to identify eligible people with epilepsy is unlikely to be replicable. A definitive trial is currently not feasible. Future work Research to more easily identify and recruit people from the target population is required. Trial registration Current Controlled Trials ISRCTN13871327. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 39. See the NIHR Journals Library website for further project information.

scholarly journals Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e039981
Author(s):  
Maleea Denise Holbert ◽  
Roy M Kimble ◽  
Mark Chatfield ◽  
Bronwyn R Griffin
Keyword(s):  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Geometric Mean ◽  
First Aid ◽  
Self Report ◽  
Thermal Burn ◽  
Pain Scores ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).

PO051 Seizure first aid training for people with epilepsy attending emergency departments, and informal carers

2017 ◽  
Vol 88 (Suppl 1) ◽  
pp. A25.2-A25 ◽  
Author(s):  
Adam J Noble ◽  
Darlene A Snape ◽  
Myfanwy Morgan ◽  
Steve Goodacre ◽  
Anthony G Marson ◽  
...  
Keyword(s):  
Emergency Departments ◽  
First Aid ◽  
First Aid Training ◽  
Informal Carers

scholarly journals Effect of community members' willingness to disclose a mental disorder on their psychiatric symptom scores: analysis of data from two randomised controlled trials of mental health first aid training

2019 ◽  
Vol 29 ◽  
Author(s):  
A. F. Jorm ◽  
A. J. Mackinnon ◽  
L. M. Hart ◽  
N. J. Reavley ◽  
A. J. Morgan
Keyword(s):  
Mental Health ◽  
Psychiatric Symptom ◽  
Psychiatric Symptoms ◽  
First Aid ◽  
Panel Analysis ◽  
First Aid Training ◽  
Willingness To Disclose ◽  
Symptom Scores ◽  
Randomised Controlled ◽  
To Receive

Abstract Aims The prevalence of common mental disorders has not declined in high-income countries despite substantial increases in service provision. A possible reason for this lack of improvement is that greater willingness to disclose mental disorders might have led to increased reporting of psychiatric symptoms, thus masking reductions in prevalence. This masking hypothesis was tested using data from two trials of interventions that increased willingness to disclose and that also measured symptoms. Both interventions involved Mental Health First Aid (MHFA) training, which is known to reduce stigma, including unwillingness to disclose a mental health problem. Methods A cross-lagged panel analysis was carried out on data from two large Australian randomised controlled trials of MHFA training. The first trial involved 1643 high school students in Year 10 (mean age 15.87 years), who were randomised to receive either teen MHFA training or physical first aid training as the control. The second trial involved 608 Australia public servants who were randomised to receive either eLearning MHFA, blended eLearning MHFA or eLearning physical first aid as the control. In both trials, willingness to disclose a mental disorder as described in vignettes and psychiatric symptoms (K6 scale) were measured pre-training, post-training and at 12-month follow-up. Results Both trials found that MHFA training increased willingness to disclose. However, a cross-lagged panel analysis showed no effect of this change on psychiatric symptom scores. Conclusions Greater willingness to disclose did not affect psychiatric symptom scores. Because the trials increased willingness to disclose through a randomly assigned intervention, they provide a strong causal test of the masking hypothesis. It is therefore unlikely that changes in willingness to disclose are masking reductions in prevalence in the population.

scholarly journals Can Ketogenic Diet Therapy Improve Migraine Frequency, Severity and Duration?

Healthcare ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1105
Author(s):  
Rebecca L. Haslam ◽  
Aaron Bezzina ◽  
Jaimee Herbert ◽  
Neil Spratt ◽  
Megan E. Rollo ◽  
...  
Keyword(s):  
Side Effects ◽  
Ketogenic Diet ◽  
Dietary Intervention ◽  
Pilot Trial ◽  
Diet Therapy ◽  
Self Report ◽  
Migraine Frequency ◽  
Important Trend ◽  
History Of ◽  
Randomised Controlled

Migraine is the third most common condition worldwide and is responsible for a major clinical and economic burden. The current pilot trial investigated whether ketogenic diet therapy (KDT) is superior to an evidence-informed healthy “anti-headache” dietary pattern (AHD) in improving migraine frequency, severity and duration. A 12-week randomised controlled crossover trial consisting of the two dietary intervention periods was undertaken. Eligible participants were those with a history of migraines and who had regularly experienced episodes of moderate or mildly intense headache in the previous 4 weeks. Migraine frequency, duration and severity were assessed via self-report in the Migraine Buddy© app. Participants were asked to measure urinary ketones and side effects throughout the KDT. Twenty-six participants were enrolled, and 16 participants completed all sessions. Eleven participants completed a symptom checklist; all reported side-effects during KDT, with the most frequently reported side effect being fatigue (n = 11). All completers experienced migraine during AHD, with 14/16 experiencing migraine during KDT. Differences in migraine frequency, severity or duration between dietary intervention groups were not statistically significant. However, a clinically important trend toward lower migraine duration on KDT was noted. Further research in this area is warranted, with strategies to lower participant burden and promote adherence and retention.

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