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PURPOSE: With epilepsy increasingly affecting older adults, seizure-related care needs arise in new settings. Persons in these settings must receive optimal support and challenges identified for remediation. This may entail the epilepsy community researching in unfamiliar environments. One setting is care homes. Seizure-related ambulance incidents in them are common. We conducted the first qualitative study with care home staff to explore their experiences and challenges in managing suspected seizures. METHODS: Three online focus groups were organised for January 2024 to explore ambulance calls, post-incident procedures, and challenges faced by care home staff when managing seizures. Persons were eligible to participate if they worked as a care assistant, nurse or manager in a care home in North-West England. Different recruitment pathways were employed including direct approach, a managers' network, social media and a register of research interested homes. Focus group audio recordings were transcribed and analysed using Hamilton's Rapid Analysis. RESULTS: Recruitment was difficult; 13 care home staff from 12 different homes were ultimately recruited. Despite data saturation not being achieved, insights were gained regarding ambulance call decisions, paperwork navigation, and follow-up care challenges. Patients not having meaningful seizure action plans in place and regulatory restrictions were identified as factors that contributed to potentially avoidable calls for ambulance help being made. CONCLUSION: This study highlights systemic issues in care homes' seizure care, emphasizing the need for further research. The epilepsy community may need to innovate to better research within this increasingly important setting. This study offers insights into the effectiveness of different recruitment strategies.
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Epilepsia , Grupos Focales , Convulsiones , Humanos , Inglaterra , Epilepsia/terapia , Convulsiones/terapia , Masculino , Femenino , Adulto , Investigación Cualitativa , Personal de Salud/psicología , Persona de Mediana Edad , AmbulanciasRESUMEN
INTRODUCTION: Deaths caused by alcohol are increasing in England and 80 % of people with alcohol use disorders (AUDs) are not in treatment. The Blue Light approach (Alcohol Change UK) is an initiative to support people with AUDs who are not in treatment. This study aimed to tailor the Blue Light approach (combined with alcohol identification and alcohol brief interventions [ABI] training) for police officers and homeless service staff in North West England, and to qualitatively evaluate the feasibility and acceptability of the training. METHODS: The Blue Light approach was tailored using co-production activities, based on Transdisciplinary Action Research. Full-day and half-day training sessions were delivered to the police (full-day N = 14, half-day N = 54) and homeless service staff (full-day N = 11, half-day N = 32), in local police stations and online (four half-day sessions). Semi-structured interviews (N = 23) were conducted to evaluate implementation and integration, analysing the qualitative data in line with Normalisation Process Theory. RESULTS: Four themes were identified, each with two to three sub-themes, reflecting: (i) the importance of training for working practice, (ii) implementation of the interventions, (iii) changes to relationships within and between organizations, and (iv) recommendations for further changes to the training. Differences in findings across the organizations (police versus homeless services) and by training type attended (full-day versus half-day, in-person versus online) are presented. CONCLUSIONS: There is evidence to suggest that the training has provided worthwhile knowledge and intervention techniques that can become embedded into working practices. Nevertheless, structural barriers were apparent, primarily within the police service, with clear disparities between recognising the value of the training and what is achievable in practice, given the competing demands.
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Alcoholismo , Policia , Humanos , Estudios de Factibilidad , Alcoholismo/epidemiología , Luz Azul , InglaterraRESUMEN
OBJECTIVES: Relatively little is known about the lived experiences of older adults during the COVID-19 pandemic. We systematically review the international literature to understand the lived experiences of older adult's experiences during the pandemic. DESIGN AND METHODOLOGY: This study uses a meta-ethnographical approach to investigate the included studies. The analyses were undertaken with constructivist grounded theory. RESULTS: Thirty-two studies met the inclusion criteria and only five papers were of low quality. Most, but not all studies, were from the global north. We identified three themes: desired and challenged wellbeing; coping and adaptation; and discrimination and intersectionality. Overall, the studies' findings were varied and reflected different times during the pandemic. Studies reported the impact of mass media messaging and its mostly negative impact on older adults. Many studies highlighted the impact of the COVID-19 pandemic on participants' social connectivity and well-being including missing the proximity of loved ones and in consequence experienced an increase in anxiety, feeling of depression, or loneliness. However, many studies reported how participants adapted to the change of lifestyle including new ways of communication, and social distancing. Some studies focused on discrimination and the experiences of sexual and gender minority and ethnic minority participants. Studies found that the pandemic impacted the participants' well-being including suicidal risk behaviour, friendship loss, and increased mental health issues. CONCLUSION: The COVID-19 pandemic disrupted and impacted older adults' well-being worldwide. Despite the cultural and socio-economic differences many commonalities were found. Studies described the impact of mass media reporting, social connectivity, impact of confinement on well-being, coping, and on discrimination. The authors suggest that these findings need to be acknowledged for future pandemic strategies. Additionally, policy-making processes need to include older adults to address their needs. PROSPERO record [CRD42022331714], (Derrer-Merk et al., Older adults' lived experiences during the COVID-19 pandemic: a systematic review, 2022).
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COVID-19 , Humanos , Anciano , COVID-19/epidemiología , Etnicidad , Grupos Minoritarios , Pandemias , EmocionesRESUMEN
OBJECTIVE: To identify the views of people with epilepsy (PWE), and their significant others, on the repurposing and trialing of statins as a potential antiepileptogenic or disease-modifying treatment for those who have had the first seizure. METHODS: Online questionnaire. Participants needed to be aged ≥ 16 years, UK residents, and able to independently complete a questionnaire in English. User groups distributed study adverts. Embedded infographics explained repurposing, why anti-seizure treatment is not typically started after a first seizure and the nature of randomized placebo-controlled trials (RCTs). The questionnaire asked participants to reflect and rate their expected willingness to have started an unspecified treatment after their first seizure/s (or that of the person with epilepsy they knew). They also rated willingness if the treatment were a statin, views of statins, the importance of an RCT of statins to their community, the outcomes it should assess, and their willingness to have taken part in it. The estimated number needed for the survey was 324. RESULTS: Responses from 213 persons were analyzed; 111 (52.1%) were PWE and 102 (47.9%) significant others. The median years diagnosed was 10 and PWE suffered from relatively severe epilepsy. One hundred and seventeen (54.9%) said they would have started an unspecified treatment after their first seizure/s (or supported the person with epilepsy they knew to have). A similar proportion (55.4%) said they would have started the treatment if it were a statin. Participants' main concern about statins, expressed by 79%, was their possible side effects. Repurposing was a concern for only 25%. Most (85.8%) rated an RCT of statins as of extreme or high importance; 54.4% said they would have participated. CONCLUSION: The PWE and significant others (SOs) responding to our survey expressed views towards repurposing statins that were generally positive and indicate a trial in those who have had a first seizure might be feasible. Concerns regarding side effects are common. Our findings could help optimize a future trial's design and the case for funding. Limitations include that we did not survey persons who had experienced a first seizure and did not go on to develop epilepsy. Also, persons with uncontrolled epilepsy were overrepresented.
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Epilepsia , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Humanos , Anticonvulsivantes/uso terapéutico , Epilepsia/tratamiento farmacológico , Epilepsia/inducido químicamente , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Encuestas y Cuestionarios , Reino Unido , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
INTRODUCTION: Polyhydramnios is common; the majority of cases are idiopathic, but maybe associated with fetal abnormality. Literature suggests the volume of amniotic fluid discriminates idiopathic from pathological polyhydramnios but is not unanimous. We assessed fetal anomaly incidence amongst women with polyhydramnios and the role of discriminatory variables in identifying pathological cases. METHODS: Retrospective observational cohort study at an inner-city London fetal medicine centre. Records for patients referred and/or diagnosed with polyhydramnios were reviewed as well as maternal/fetal demographics, amongst singleton pregnancies using the Astraia™ database from January 2015-2016. Estimated fetal weight was calculated using the Hadlock model (biometry undertaken at diagnosis). Student's t-test/one-way ANOVA compared means; chi-squared tests compared proportions. RESULTS: 120 cases were identified. 36 (30%) had fetal abnormality. There was no difference in AFI between fetuses with an abnormality and without (26.7 vs 25.2 cm, P = 0.22). AFI was normalised for weight (AFI (cm)/estimated fetal weight (kg)): AFI/kg was significantly different between cases with fetal abnormality and without (24.4 vs 16.7 cm/kg, P < 0.001) - incidence of abnormality increased with increasing AFI/kg (P = 0.007). Early gestational diagnosis was associated with higher rates of anomaly (P = 0.004). Differences in AFI/kg between those with and without abnormality were not significant when adjusted for gestation. AFI was significantly higher in cases of abnormality diagnosed at later gestation (P = 0.005). CONCLUSION: Excess volume of amniotic fluid alone does not denote abnormality. Earlier gestations and higher AFI/kg corresponded with significantly increased rates of anomaly. However, the latter is a result of confounding by gestation, which is closely correlated with fetal weight.
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BACKGROUND: Routine measurement of gastric residual volume (GRV) to guide feeding in neonatal and paediatric intensive care is widespread. However, this practice is not evidence based and may cause harm. As part of a feasibility study, we explored parent and practitioner views on the acceptability of a trial comparing GRV measurement or no GRV measurement. METHODS: A mixed-methods study involving interviews and focus groups with practitioners and interviews with parents with experience of tube feeding in neonatal and/or paediatric intensive care. A voting system recorded closed question responses during practitioner data collection, enabling the collection of quantitative and qualitative data. Data were analysed using thematic analysis and descriptive statistics. RESULTS: We interviewed 31 parents and nine practitioners and ran five practitioner focus groups (n=42). Participants described how the research question was logical, and the intervention would not be invasive and potential benefits of not withholding the child's feeds. However, both groups held concerns about the potential risk of not measuring GRV, including delayed diagnosis of infection and gut problems, increased risk of vomiting into lungs and causing discomfort or pain. Parent's views on GRV measurement and consent decision making were influenced by their views on the importance of feeding in the ICU, their child's prognosis and associated comorbidities or complications. CONCLUSIONS: The majority of parents and practitioners viewed the proposed trial as acceptable. Potential concerns and preferences were identified that will need careful consideration to inform the development of the proposed trial protocol and staff training.
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BACKGROUND: Alternatives to prospective informed consent enable the conduct of paediatric emergency and critical care trials. Research without prior consent (RWPC) involves practitioners approaching parents after an intervention has been given and seeking consent for their child to continue in the trial. As part of an embedded study in the 'Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children' (EcLiPSE) trial, we explored how practitioners described the trial and RWPC during recruitment discussions, and how well this information was understood by parents. We aimed to develop a framework to assist trial conversations in future paediatric emergency and critical care trials using RWPC. METHODS: Qualitative methods embedded within the EcLiPSE trial processes, including audiorecorded practitioner-parent trial discussions and telephone interviews with parents. We analysed data using thematic analysis, drawing on the Realpe et al (2016) model for recruitment to trials. RESULTS: We analysed 76 recorded trial discussions and conducted 30 parent telephone interviews. For 19 parents, we had recorded trial discussion and interview data, which were matched for analysis. Parental understanding of the EcLiPSE trial was enhanced when practitioners: provided a comprehensive description of trial aims; explained the reasons for RWPC; discussed uncertainty about which intervention was best; provided a balanced description of trial intervention; provided a clear explanation about randomisation and provided an opportunity for questions. We present a seven-step framework to assist recruitment practice in trials involving RWPC. CONCLUSION: This study provides a framework to enhance recruitment practice and parental understanding in paediatric emergency and critical care trials involving RWPC. Further testing of this framework is required.
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Cuidados Críticos , Servicio de Urgencia en Hospital , Levetiracetam/uso terapéutico , Padres/psicología , Fenitoína/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Estado Epiléptico/tratamiento farmacológico , Anticonvulsivantes/uso terapéutico , Niño , Recolección de Datos/métodos , Inglaterra , Femenino , Humanos , Consentimiento Informado , Masculino , Estudios Multicéntricos como Asunto , Ensayos Clínicos Pragmáticos como Asunto , Investigación CualitativaRESUMEN
BACKGROUND: Choosing trial outcome measures is important. When outcomes are not clinically relevant or important to parents/patients, trial evidence is less likely to be implemented into practice. This study aimed to determine optimal outcome measures for a trial of no routine gastric residual volume (GRV) measurement in critically ill children. METHODS: A mixed-methods approach was used: a focused literature review, parent and clinician interviews, a modified 2-round Delphi, and a stakeholder consensus meeting. RESULTS: The review generated 13 outcomes. Fourteen pediatric intensive care unit (PICU) parents proposed 3 additional outcomes; these 16 were then rated by 28 clinicians in Delphi round 1. Six further outcomes were proposed, and 22 outcomes were rated in the second round. No items were voted "consensus out." The 18 "no-consensus" items were voted in a face-to-face meeting by 30 participants. The final 12 outcome measures were time to reach energy targets, ventilator-associated pneumonia, vomiting, time enteral feeds withheld per 24 hours, necrotizing enterocolitis, length of invasive ventilation, PICU length of stay, mortality, change in weight and markers of feed intolerance (parenteral nutrition administered), feed formula altered, and change to postpyloric feeds all secondary to feed intolerance. CONCLUSION: We have identified 12 outcomes for a trial of no GRV measurement through a multistage process, seeking views of parents and clinicians.
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Enfermedad Crítica , Nutrición Enteral , Niño , Humanos , Recién Nacido , Evaluación de Resultado en la Atención de Salud , Volumen Residual , EstómagoRESUMEN
BACKGROUND: Key challenges to the successful conduct of The Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE) trial were identified at the pre-trial stage. These included practitioner anxieties about conducting research without prior consent (RWPC), inexperience in conducting an ED-led trial and use of a medication that was not usual ED practice. As part of an embedded study, we explored parent and practitioner experiences of recruitment, RWPC and conduct of the trial to inform the design and conduct of future ED-led trials. METHODS: A mixed-methods study within a trial involving (1) questionnaires and interviews with parents of randomised children, (2) interviews and focus groups with EcLiPSE practitioners and (3) audio-recorded trial discussions. We analysed data using thematic analysis and descriptive statistics as appropriate. RESULTS: A total of 143 parents (93 mothers, 39 fathers, 11 missing information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers) were interviewed. We analysed 76 recorded trial recruitment discussions. Ten practitioners (4 medical, 6 nursing) were interviewed, 36 (16 medical, 20 nursing) participated in one of six focus groups. Challenges to the success of the trial were addressed by having a clinically relevant research question, pragmatic trial design, parent and practitioner support for EcLiPSE recruitment and research without prior consent processes, and practitioner motivation and strong leadership. Lack of leadership negatively affected practitioner engagement and recruitment. EcLiPSE completed on time, achieving its required sample size target. CONCLUSIONS: Successful trial recruitment and conduct in a challenging ED-led trial was driven by trial design, recruitment experience, teamwork and leadership. Our study provides valuable insight from parents and practitioners to inform the design and conduct of future trials in this setting.
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Servicio de Urgencia en Hospital , Levetiracetam/uso terapéutico , Padres/psicología , Fenitoína/uso terapéutico , Ensayos Clínicos Pragmáticos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Estado Epiléptico/tratamiento farmacológico , Anticonvulsivantes/uso terapéutico , Niño , Recolección de Datos/métodos , Inglaterra , Femenino , Humanos , Masculino , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: Routine measurement of gastric residual volume to guide feeding is widespread in neonatal units but not supported by high-quality evidence. Outcome selection is critical to trial design. OBJECTIVE: To determine optimal outcome measures for a trial of not routinely measuring gastric residual volume in neonatal care. DESIGN: A focused literature review, parent interviews, modified two-round Delphi survey and stakeholder consensus meeting. PARTICIPANTS: Sixty-one neonatal healthcare professionals participated in an eDelphi survey; 17 parents were interviewed. 19 parents and neonatal healthcare professionals took part in the consensus meeting. RESULTS: Literature review generated 14 outcomes, and parent interviews contributed eight additional outcomes; these 22 outcomes were then ranked by 74 healthcare professionals in the first Delphi round where four further outcomes were proposed; 26 outcomes were ranked in the second round by 61 healthcare professionals. Five outcomes were categorised as 'consensus in', and no outcomes were voted 'consensus out'. 'No consensus' outcomes were discussed and voted on in a face-to-face meeting by 19 participants, where four were voted 'consensus in'. The final nine consensus outcomes were: mortality, necrotising enterocolitis, time to full enteral feeds, duration of parenteral nutrition, time feeds stopped per 24 hours, healthcare-associated infection; catheter-associated bloodstream infection, change in weight between birth and neonatal discharge and pneumonia due to milk aspiration. CONCLUSIONS AND RELEVANCE: We have identified outcomes for a trial of no routine measurement of gastric residual volume to guide feeding in neonatal care. This outcome set will ensure outcomes are important to healthcare professionals and parents.
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Pesos y Medidas Corporales/métodos , Nutrición Enteral , Neumonía por Aspiración/prevención & control , Mejoramiento de la Calidad/normas , Estómago/anatomía & histología , Consenso , Técnica Delphi , Pruebas Diagnósticas de Rutina/métodos , Duración de la Terapia , Nutrición Enteral/métodos , Nutrición Enteral/normas , Enterocolitis Necrotizante/terapia , Humanos , Recién Nacido , Cuidado Intensivo Neonatal/normas , Tamaño de los Órganos , Evaluación de Resultado en la Atención de Salud/normas , Nutrición Parenteral/métodos , Neumonía por Aspiración/etiología , Utilización de Procedimientos y TécnicasRESUMEN
PURPOSE: Feelings of loneliness are likely to exacerbate risk of depression in people living with cancer during COVID-19. DESIGN AND METHODS: Five hundred and eighteen people with cancer with data extracted from two waves (2017-19 and April 2020) of the Understanding Society UK dataset participated. FINDINGS: An increased risk of depression was observed for cancer of the breast, prostate, blood, but not other cancers (e.g., lung, melanoma). After controlling for prior depression and other factors, it was loneliness during COVID-19, and not previous loneliness, that was predictive. Those currently lonely had a 4.5-fold increased risk of depression. These findings demonstrate that people living with cancer are at increased risk of developing depression during COVID-19, and that feelings of isolation help explain this risk. IMPLICATIONS: These particular findings have implications for health promotion and intervention work and how best to support people who may feel lonely in this vulnerable group.
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Depresión/psicología , Soledad/psicología , Neoplasias/psicología , Aislamiento Social , Anciano , Depresión/epidemiología , Femenino , Conductas Relacionadas con la Salud , Accesibilidad a los Servicios de Salud , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Neoplasias/epidemiología , Neoplasias/terapia , Reino Unido/epidemiologíaRESUMEN
BACKGROUND: Convulsive status epilepticus is the most common neurological emergency in children. Its management is important to avoid or minimise neurological morbidity and death. The current first-choice second-line drug is phenytoin (Epanutin, Pfizer Inc., New York, NY, USA), for which there is no robust scientific evidence. OBJECTIVE: To determine whether phenytoin or levetiracetam (Keppra, UCB Pharma, Brussels, Belgium) is the more clinically effective intravenous second-line treatment of paediatric convulsive status epilepticus and to help better inform its management. DESIGN: A multicentre parallel-group randomised open-label superiority trial with a nested mixed-method study to assess recruitment and research without prior consent. SETTING: Participants were recruited from 30 paediatric emergency departments in the UK. PARTICIPANTS: Participants aged 6 months to 17 years 11 months, who were presenting with convulsive status epilepticus and were failing to respond to first-line treatment. INTERVENTIONS: Intravenous levetiracetam (40 mg/kg) or intravenous phenytoin (20 mg/kg). MAIN OUTCOME MEASURES: Primary outcome - time from randomisation to cessation of all visible signs of convulsive status epilepticus. Secondary outcomes - further anticonvulsants to manage the convulsive status epilepticus after the initial agent, the need for rapid sequence induction owing to ongoing convulsive status epilepticus, admission to critical care and serious adverse reactions. RESULTS: Between 17 July 2015 and 7 April 2018, 286 participants were randomised, treated and consented. A total of 152 participants were allocated to receive levetiracetam and 134 participants to receive phenytoin. Convulsive status epilepticus was terminated in 106 (70%) participants who were allocated to levetiracetam and 86 (64%) participants who were allocated to phenytoin. Median time from randomisation to convulsive status epilepticus cessation was 35 (interquartile range 20-not assessable) minutes in the levetiracetam group and 45 (interquartile range 24-not assessable) minutes in the phenytoin group (hazard ratio 1.20, 95% confidence interval 0.91 to 1.60; p = 0.2). Results were robust to prespecified sensitivity analyses, including time from treatment commencement to convulsive status epilepticus termination and competing risks. One phenytoin-treated participant experienced serious adverse reactions. LIMITATIONS: First, this was an open-label trial. A blinded design was considered too complex, in part because of the markedly different infusion rates of the two drugs. Second, there was subjectivity in the assessment of 'cessation of all signs of continuous, rhythmic clonic activity' as the primary outcome, rather than fixed time points to assess convulsive status epilepticus termination. However, site training included simulated demonstration of seizure cessation. Third, the time point of randomisation resulted in convulsive status epilepticus termination prior to administration of trial treatment in some cases. This affected both treatment arms equally and had been prespecified at the design stage. Last, safety measures were a secondary outcome, but the trial was not powered to demonstrate difference in serious adverse reactions between treatment groups. CONCLUSIONS: Levetiracetam was not statistically superior to phenytoin in convulsive status epilepticus termination rate, time taken to terminate convulsive status epilepticus or frequency of serious adverse reactions. The results suggest that it may be an alternative to phenytoin in the second-line management of paediatric convulsive status epilepticus. Simple trial design, bespoke site training and effective leadership were found to facilitate practitioner commitment to the trial and its success. We provide a framework to optimise recruitment discussions in paediatric emergency medicine trials. FUTURE WORK: Future work should include a meta-analysis of published studies and the possible sequential use of levetiracetam and phenytoin or sodium valproate in the second-line treatment of paediatric convulsive status epilepticus. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22567894 and European Clinical Trials Database EudraCT number 2014-002188-13. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 58. See the NIHR Journals Library website for further project information.
Most epileptic tonicclonic seizures, also called convulsions, last for < 4 minutes and stop spontaneously. A convulsion that lasts for > 5 minutes is called convulsive status epilepticus. This may cause neurological abnormalities or, rarely, death. There is good scientific evidence for the best first-line medicine, called a benzodiazepine, to stop convulsive status epilepticus. When a benzodiazepine has not stopped status, a second-line medicine is given. The usual second-line medicine, which has been used for > 50 years, is phenytoin (Epanutin, Pfizer Inc., New York, NY, USA). However, it stops status in only half of children. It must be given slowly because it can cause unpleasant and potentially serious side effects. A new medicine called levetiracetam (Keppra, UCB Pharma, Brussels, Belgium) may be more effective. It seems to have less serious side effects than phenytoin. However, there is no good scientific evidence as to whether phenytoin or levetiracetam is better. A randomised controlled trial is the best scientific way to decide which of these two medicines is better. The Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE) trial was a randomised controlled trial that compared levetiracetam with phenytoin. A total of 152 children were randomised to receive levetiracetam and a total of 134 children were randomised to receive phenytoin. Research without prior consent was shown to be acceptable to parents, doctors and nurses. Parents' consent to use their child's data and continue in the trial was provided after the emergency situation was resolved. Convulsive status epilepticus stopped in 70.4% of the levetiracetam-treated children and in 64% of the phenytoin-treated children. The median time to status stopping was 35 minutes in the levetiracetam-treated children and 45 minutes in the phenytoin-treated children. Only one participant on phenytoin (vs. none on levetiracetam) experienced serious side effects that were thought to be caused by their treatment. None of the results showed any statistically significant or meaningful difference between levetiracetam and phenytoin. However, the results suggest that levetiracetam might be an alternative choice to phenytoin.
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Anticonvulsivantes/uso terapéutico , Levetiracetam/uso terapéutico , Fenitoína/uso terapéutico , Estado Epiléptico/tratamiento farmacológico , Administración Intravenosa , Adolescente , Anticonvulsivantes/administración & dosificación , Niño , Preescolar , Estudios de Equivalencia como Asunto , Femenino , Humanos , Lactante , Levetiracetam/administración & dosificación , Masculino , Fenitoína/administración & dosificación , Reino UnidoRESUMEN
OBJECTIVE: Despite little evidence, the practice of routine gastric residual volume (GRV) measurement to guide enteral feeding in neonatal units is widespread. Due to increased interest in this practice, and to examine trial feasibility, we aimed to determine enteral feeding and GRV measurement practices in British neonatal units. DESIGN AND SETTING: An online survey was distributed via email to all neonatal units and networks in England, Scotland and Wales. A clinical nurse, senior doctor and dietitian were invited to collaboratively complete the survey and submit a copy of relevant guidelines. RESULTS: 95/184 (51.6%) approached units completed the survey, 81/95 (85.3%) reported having feeding guidelines and 28 guidelines were submitted for review. The majority of units used intermittent (90/95) gastric feeds as their primary feeding method. 42/95 units reported specific guidance for measuring and interpreting GRV. 20/90 units measured GRV before every feed, 39/90 at regular time intervals (most commonly four to six hourly 35/39) and 26/90 when felt to be clinically indicated. Most units reported uncertainty on the utility of aspirate volume for guiding feeding decisions; 13/90 reported that aspirate volume affected decisions 'very much'. In contrast, aspirate colour was reported to affect decisions 'very much' by 37/90 of responding units. Almost half, 44/90, routinely returned aspirates to the stomach. CONCLUSIONS: Routine GRV measurement is part of standard practice in British neonatal units, although there was inconsistency in how frequently to measure or how to interpret the aspirate. Volume was considered less important than colour of the aspirate.
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BACKGROUND: In the UK, juvenile idiopathic arthritis is the most common inflammatory disorder in childhood, affecting 10 : 100,000 children and young people aged < 16 years each year, with a population prevalence of around 1 : 1000. Corticosteroids are commonly used to treat juvenile idiopathic arthritis; however, there is currently a lack of consensus as to which corticosteroid induction regimen should be used with various disease subtypes and severities of juvenile idiopathic arthritis. OBJECTIVE: The main study objective was to determine the feasibility of conducting a randomised controlled trial to compare the different corticosteroid induction regimens in children and young people with juvenile idiopathic arthritis. DESIGN: This was a mixed-methods study. Work packages included a literature review; qualitative interviews with children and young people with juvenile idiopathic arthritis and their families; a questionnaire survey and screening log to establish current UK practice; a consensus meeting with health-care professionals, children and young people with juvenile idiopathic arthritis, and their families to establish the primary outcome; a feasibility study to pilot data capture and to collect data for future sample size calculations; and a final consensus meeting to establish the final protocol. SETTING: The setting was rheumatology clinics across the UK. PARTICIPANTS: Children, young people and their families who attended clinics and health-care professionals took part in this mixed-methods study. INTERVENTIONS: This study observed methods of prescribing corticosteroids across the UK. MAIN OUTCOME MEASURES: The main study outcomes were the acceptability of a future trial for children, young people, their families and health-care professionals, and the feasibility of delivering such a trial. RESULTS: Qualitative interviews identified differences in the views of children, young people and their families on a randomised controlled trial and potential barriers to recruitment. A total of 297 participants were screened from 13 centres in just less than 6 months. In practice, all routes of corticosteroid administration were used, and in all subtypes of juvenile idiopathic arthritis. Intra-articular corticosteroid injection was the most common treatment. The questionnaire surveys showed the varying clinical practice across the UK, but established intra-articular corticosteroids as the treatment control for a future trial. The primary outcome of choice for children, young people, their families and health-care professionals was the Juvenile Arthritis Disease Activity Score, 71-joint count. However, results from the feasibility study showed that, owing to missing blood test data, the clinical Juvenile Arthritis Disease Activity Score should be used. The Juvenile Arthritis Disease Activity Score, 71-joint count, and the clinical Juvenile Arthritis Disease Activity Score are composite disease activity scoring systems for juvenile arthritis. Two final trial protocols were established for a future randomised controlled trial. LIMITATIONS: Fewer clinics were included in this feasibility study than originally planned, limiting the ability to draw strong conclusions about these units to take part in future research. CONCLUSIONS: A definitive randomised controlled trial is likely to be feasible based on the findings from this study; however, important recommendations should be taken into account when planning such a trial. FUTURE WORK: This mixed-methods study has laid down the foundations to develop the evidence base in this area and conducting a randomised control trial to compare different corticosteroid induction regimens in children and young people with juvenile idiopathic arthritis is likely to be feasible. STUDY REGISTRATION: Current Controlled Trials ISRCTN16649996. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 36. See the NIHR Journals Library website for further project information.
ABOUT JUVENILE IDIOPATHIC ARTHRITIS: Juvenile idiopathic arthritis refers to a group of conditions that cause inflammation and damage of the joints, starting in children and young people aged < 16 years. Treatments include anti-inflammatory medicines, disease-modifying/biologic medicines and corticosteroids. Young people often require corticosteroids at the start of their treatment, or in a flare with worsening inflammation, to get their juvenile idiopathic arthritis under control. A short course of corticosteroids can help and can be given by injection into the joint, through a drip into a vein, by injection into the muscle or in the form of tablets or liquid to be taken orally. Although they have been used for decades, there is no research to show the best way(s) of giving corticosteroids. STUDY AIMS: The study aimed to (1) agree on what corticosteroid treatments to compare in a treatment trial and the best way to measure changes in juvenile idiopathic arthritis to evaluate a quick-acting treatment and (2) find out if there are enough young people with active juvenile idiopathic arthritis in the UK to be included in such a study. METHODS: Published research on corticosteroids in juvenile idiopathic arthritis was reviewed. Health-care professionals were asked how they choose which corticosteroids to use and which method of administration to use. Interviews were carried out with children and young people and their families to (1) consider the design of a study comparing corticosteroid routes, (2) identify outcomes important to them and (3) determine whether or not they would be willing to take part in a future study. A 3-month feasibility study was carried out to collect details of children and young people with active juvenile idiopathic arthritis before and after corticosteroid treatment to measure improvements in juvenile idiopathic arthritis activity, and to see whether or not a larger study would be possible. FINDINGS: This study showed that corticosteroids are used in different ways across the UK. The views of children, young people and their families must be taken into account when designing a future study. This study calculated the number of young people who would be needed to take part in the future, showing that it would be possible to do a larger study that compared different corticosteroid treatments, which would help everyone to understand the best way to use corticosteroids.
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Corticoesteroides/administración & dosificación , Artritis Juvenil/tratamiento farmacológico , Protocolos Clínicos/normas , Encuestas y Cuestionarios/estadística & datos numéricos , Adolescente , Niño , Vías de Administración de Medicamentos , Estudios de Factibilidad , Femenino , Humanos , Inyecciones Intraarticulares , Masculino , Evaluación de Resultado en la Atención de Salud , Pautas de la Práctica en Medicina/normas , Ensayos Clínicos Controlados Aleatorios como Asunto , Reino UnidoRESUMEN
BACKGROUND: The routine measurement of gastric residual volume to guide the initiation and delivery of enteral feeding is widespread in paediatric intensive care and neonatal units, but has little underlying evidence to support it. OBJECTIVE: To answer the question: is a trial of no gastric residual volume measurement feasible in UK paediatric intensive care units and neonatal units? DESIGN: A mixed-methods study involving five linked work packages in two parallel arms: neonatal units and paediatric intensive care units. Work package 1: a survey of units to establish current UK practice. Work package 2: qualitative interviews with health-care professionals and caregivers of children admitted to either setting. Work package 3: a modified two-round e-Delphi survey to investigate health-care professionals' opinions on trial design issues and to obtain consensus on outcomes. Work package 4: examination of national databases to determine the potential eligible populations. Work package 5: two consensus meetings of health-care professionals and parents to review the data and agree consensus on outcomes that had not reached consensus in the e-Delphi study. PARTICIPANTS AND SETTING: Parents of children with experience of ventilation and tube feeding in both neonatal units and paediatric intensive care units, and health-care professionals working in neonatal units and paediatric intensive care units. RESULTS: Baseline surveys showed that the practice of gastric residual volume measurement was very common (96% in paediatric intensive care units and 65% in neonatal units). Ninety per cent of parents from both neonatal units and paediatric intensive care units supported a future trial, while highlighting concerns around possible delays in detecting complications. Health-care professionals also indicated that a trial was feasible, with 84% of staff willing to participate in a trial. Concerns expressed by junior nurses about the intervention arm of not measuring gastric residual volumes were addressed by developing a simple flow chart and education package. The trial design survey and e-Delphi study gained consensus on 12 paediatric intensive care unit and nine neonatal unit outcome measures, and identified acceptable inclusion and exclusion criteria. Given the differences in physiology, disease processes, environments, staffing and outcomes of interest, two different trials are required in the two settings. Database analyses subsequently showed that trials were feasible in both settings in terms of patient numbers. Of 16,222 children who met the inclusion criteria in paediatric intensive care units, 12,629 stayed for > 3 days. In neonatal units, 15,375 neonates < 32 weeks of age met the inclusion criteria. Finally, the two consensus meetings demonstrated 'buy-in' from the wider UK neonatal communities and paediatric intensive care units, and enabled us to discuss and vote on the outcomes that did not achieve consensus in the e-Delphi study. CONCLUSIONS AND FUTURE WORK: Two separate UK trials (one in neonatal units and one in paediatric intensive care units) are feasible to conduct, but they cannot be combined as a result of differences in outcome measures and treatment protocols, reflecting the distinctness of the two specialties. TRIAL REGISTRATION: Current Controlled Trials ISRCTN42110505. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 23. See the NIHR Journals Library website for further project information.
Nurses looking after babies and children on intensive care units in the UK usually pass a tube and aspirate whatever food or fluid is in the baby's stomach before they give a feed. The idea is to ensure that the stomach is not overdistended with food and prevent the baby vomiting or, worse, aspirating food into the lungs. However, there is little justification for this practice. It is rarely done in many other countries. It may not be pleasant for the child and perhaps is unnecessary. Some experts have suggested that the policy should be evaluated in a randomised controlled trial. This would mean allocating a large number of children at random to either have the stomach aspirated before feeds, or not. Such a trial would be a major undertaking and we are unsure if parents or staff would be willing to allow children to participate. The aim of this study was to see if it is possible to conduct such a large trial in the UK. Two surveys (of 119 units) showed us that regularly measuring the stomach contents when starting and increasing feeds is common practice for both newborn and older children in UK intensive care units. However, in some countries, such as France, this practice is rarely done. We asked 31 parents and 51 health-care professionals about a future study. Overall, parents were supportive of a trial if it was explained to them well by a knowledgeable and caring professional, and if they were approached at the right time. Some concerns were expressed about not picking up complications early if gastric residual volume was not measured. Health-care professionals were also mainly positive about a future trial, but mentioned similar concerns about not picking up complications early and the difficulty of changing a long-standing routine practice. Parents suggested study outcomes that were important to them. These, along with other outcomes, were voted on in a further survey of 106 professionals and at face-to-face meetings involving 41 participants. Overall, our findings suggest that a trial is feasible to perform and acceptable to parents. However, because of differences in both treatments and important outcomes between children's intensive care units and newborn baby intensive care units, two trials would be needed, one in each type of intensive care unit. These two trials will test whether or not the benefits of not measuring gastric residual volume (e.g. improved calorie intake) outweigh the potential harms (e.g. delayed diagnosis of complications).
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Nutrición Enteral , Unidades de Cuidado Intensivo Pediátrico , Cuidado Intensivo Neonatal , Volumen Residual , Respiración Artificial , Niño , Técnica Delphi , Práctica Clínica Basada en la Evidencia/normas , Estudios de Factibilidad , Femenino , Personal de Salud , Hospitalización , Humanos , Lactante , Recién Nacido , Entrevistas como Asunto , Masculino , Padres , Reino UnidoRESUMEN
OBJECTIVES: Despite little evidence, the practice of routine measurement of gastric residual volume to guide both the initiation and delivery of enteral feeding in PICUs is widespread internationally. In light of increased scrutiny of the evidence surrounding this practice, and as part of a trial feasibility study, we aimed to determine enteral feeding and gastric residual volume measurement practices in U.K. PICUs. DESIGN: An online survey to 27 U.K. PICUs. SETTING: U.K. PICUs. SUBJECTS: A clinical nurse, senior doctor, and dietician were invited to collaboratively complete one survey per PICU and send a copy of their unit guidelines on enteral feeding and gastric residual volume. INTERVENTIONS: None. MEASUREMENT AND MAIN RESULTS: Twenty-four of 27 units (89%) approached completed the survey. Twenty-three units (95.8%; 23/24) had written feeding guidelines, and 19 units (19/23; 83%) sent their guidelines for review. More units fed continuously (15/24; 62%) than intermittently (9/24; 37%) via the gastric route as their primary feeding method. All but one PICU routinely measured gastric residual volume, regardless of the method of feeding. Eighteen units had an agreed definition of feed tolerance, and all these included gastric residual volume. Gastric residual volume thresholds for feed tolerance were either volume based (mL/kg body weight) (11/21; 52%) or a percentage of the volume of feed administered (6/21; 29%). Yet only a third of units provided guidance about the technique of gastric residual volume measurement. CONCLUSIONS: Routine gastric residual volume measurement is part of standard practice in U.K. PICUs, with little guidance provided about the technique which may impact the accuracy of gastric residual volume. All PICUs that defined feed tolerance included gastric residual volume in the definition. This is important to know when proposing a standard practice arm of any future trial of no-routine gastric residual volume measurement in critically ill children.
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Cuidados Críticos/métodos , Nutrición Enteral/métodos , Vaciamiento Gástrico , Guías de Práctica Clínica como Asunto , Estudios de Factibilidad , Humanos , Recién Nacido , Unidades de Cuidado Intensivo Pediátrico/estadística & datos numéricos , Encuestas y Cuestionarios , Reino UnidoRESUMEN
BACKGROUND: Phenytoin is the recommended second-line intravenous anticonvulsant for treatment of paediatric convulsive status epilepticus in the UK; however, some evidence suggests that levetiracetam could be an effective and safer alternative. This trial compared the efficacy and safety of phenytoin and levetiracetam for second-line management of paediatric convulsive status epilepticus. METHODS: This open-label, randomised clinical trial was undertaken at 30 UK emergency departments at secondary and tertiary care centres. Participants aged 6 months to under 18 years, with convulsive status epilepticus requiring second-line treatment, were randomly assigned (1:1) using a computer-generated randomisation schedule to receive levetiracetam (40 mg/kg over 5 min) or phenytoin (20 mg/kg over at least 20 min), stratified by centre. The primary outcome was time from randomisation to cessation of convulsive status epilepticus, analysed in the modified intention-to-treat population (excluding those who did not require second-line treatment after randomisation and those who did not provide consent). This trial is registered with ISRCTN, number ISRCTN22567894. FINDINGS: Between July 17, 2015, and April 7, 2018, 1432 patients were assessed for eligibility. After exclusion of ineligible patients, 404 patients were randomly assigned. After exclusion of those who did not require second-line treatment and those who did not consent, 286 randomised participants were treated and had available data: 152 allocated to levetiracetam, and 134 to phenytoin. Convulsive status epilepticus was terminated in 106 (70%) children in the levetiracetam group and in 86 (64%) in the phenytoin group. Median time from randomisation to cessation of convulsive status epilepticus was 35 min (IQR 20 to not assessable) in the levetiracetam group and 45 min (24 to not assessable) in the phenytoin group (hazard ratio 1·20, 95% CI 0·91-1·60; p=0·20). One participant who received levetiracetam followed by phenytoin died as a result of catastrophic cerebral oedema unrelated to either treatment. One participant who received phenytoin had serious adverse reactions related to study treatment (hypotension considered to be immediately life-threatening [a serious adverse reaction] and increased focal seizures and decreased consciousness considered to be medically significant [a suspected unexpected serious adverse reaction]). INTERPRETATION: Although levetiracetam was not significantly superior to phenytoin, the results, together with previously reported safety profiles and comparative ease of administration of levetiracetam, suggest it could be an appropriate alternative to phenytoin as the first-choice, second-line anticonvulsant in the treatment of paediatric convulsive status epilepticus. FUNDING: National Institute for Health Research Health Technology Assessment programme.
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Anticonvulsivantes/administración & dosificación , Levetiracetam/administración & dosificación , Fenitoína/administración & dosificación , Estado Epiléptico/tratamiento farmacológico , Adolescente , Anticonvulsivantes/efectos adversos , Niño , Preescolar , Esquema de Medicación , Epilepsia Refractaria/tratamiento farmacológico , Servicio de Urgencia en Hospital , Femenino , Humanos , Lactante , Levetiracetam/efectos adversos , Masculino , Fenitoína/efectos adversos , Resultado del Tratamiento , Reino UnidoRESUMEN
BACKGROUND: EcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom. Challenges to success include the need to immediately administer an intervention without informed consent and changes in staffing during trial conduct, mainly due to physician rotations. Using literature on parents' perspectives and research without prior consent (RWPC) guidance, we developed an interactive training package (including videos, simulation and question and answer sessions) and evaluated its dissemination and impact upon on practitioners' confidence in recruitment and consent. METHODS: Questionnaires were administered before and immediately after training followed by telephone interviews (mean 11 months later), focus groups (mean 14 months later) and an online questionnaire (8 months before trial closure). RESULTS: One hundred and twenty-five practitioners from 26/30 (87%) participating hospitals completed a questionnaire before and after training. We conducted 10 interviews and six focus groups (comprising 36 practitioners); 199 practitioners working in all recruiting hospitals completed the online questionnaire. Before training, practitioners were concerned about recruitment and consent. Confidence increased after training for explaining (all scale 0-5, 95% CIs above 0 and p values < 0.05): the study (66% improved mean score before 3.28 and after 4.52), randomisation (47% improvement, 3.86 to 4.63), RWPC (72% improvement, 2.98 to 4.39), and addressing parents' objections to randomisation (51% improvement, 3.37 to 4.25). Practitioners rated highly the content and clarity of the training, which was successfully disseminated. Some concerns about staff availability for training and consent discussions remained. CONCLUSIONS: Training improved practitioners' confidence in recruitment and RWPC. Our findings highlight the value of using parents' perspectives to inform training and to engage practitioners in trials that are at high risk of being too challenging to conduct.
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Urgencias Médicas , Consentimiento Informado , Levetiracetam/uso terapéutico , Selección de Paciente , Fenitoína/uso terapéutico , Estado Epiléptico/tratamiento farmacológico , Humanos , Proyectos de InvestigaciónRESUMEN
Background: Research shows that formal and informal social support can facilitate resilience in carers. There is a paucity of research exploring social support and resilience amongst recently bereaved informal carers. Aim: To examine how the presence or absence of distinct dimensions of social support facilitate or hinder resilience in recently bereaved informal carers. Participants: 44 bereaved carers, who had been identified by GP as 'main carer' of someone recently deceased (3-12 months), aged between 38 and 87 years old (mean= 67). Methods: Thematic analysis then the Ecological Framework of Resilience as an organisational tool to develop overarching themes in the data. We used the Sherbourne and Stewart model to identify social support that was lacking as well as social support that was present. Results: A range of social support types were identified. There was an emphasis on the importance of relationships with both health professionals and family members, including the care recipient. However, social support was not necessary for resilience if the participant had other resources. Conclusions: Social support for carers providing end of life care is almost exclusively based around end of life care 'work'. In comparison to other research our study suggests that relationships with family and health professionals are paramount. Multidimensional support is needed for carers to enhance their resilience.
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Cuidadores/psicología , Resiliencia Psicológica , Apoyo Social , Cuidado Terminal/psicología , Adulto , Anciano , Anciano de 80 o más Años , Aflicción , Familia/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Relaciones Profesional-Paciente , Investigación CualitativaRESUMEN
BACKGROUND: Patient recruitment can be very challenging in paediatric studies, especially in relatively uncommon conditions, such as juvenile idiopathic arthritis (JIA). However, involving children and young people (CYP) in the design of such trials could promise a more rapid trajectory towards making evidence-based treatments available. Studies involving CYP are advocated in the literature but we are not aware of any early stage feasibility studies that have qualitatively accessed the perspectives of parents and CYP with a long term condition to inform design and conduct of a trial. In the context of a feasibility study to inform the design of a proposed randomised controlled trial of corticosteroid induction regimen in JIA, we explored families' perspectives on the proposed trial and on JIA trials generally. METHODS: We analysed interviews with 27 participants (8 CYP aged 8-16 years and 19 parents) from four UK paediatric rheumatology centres. CYP had recently received corticosteroids to treat JIA. Audio-recorded interviews were transcribed and analysed thematically, drawing on the Framework Method. RESULTS: Both parents and CYP were capable of engaging with the logic of the proposed trial but pointed to challenges with its design. Treatment preferences influenced willingness to participate in the proposed trial. The preferences of older children and their parents often differed, with CYP being more willing to participate in the proposed trial than parents. Families' current treatment preferences were largely informed by past positive and negative treatment experiences. Some participants also indicated that their treatment preferences were influenced by those of their clinicians. CONCLUSION: Previous research has typically focused on deficits in patients' understandings of trials. We found that both parents and CYP understood trial concepts and were able to identify potential flaws in the proposed trial. We propose recommendations to optimise the design of a planned corticosteroid induction regimen trial in JIA. Accessing both parents' and CYP's perspectives helps to identify and address recruitment challenges, which will ultimately optimise informed consent and future recruitment.