scholarly journals Bypassing nearest hospital for more distant neuroscience care in head-injured adults with suspected traumatic brain injury: findings of the head injury transportation straight to neurosurgery (HITS-NS) pilot cluster randomised trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e016355 ◽  
Author(s):  
Fiona Elizabeth Lecky ◽  
Wanda Russell ◽  
Graham McClelland ◽  
Elspeth Pennington ◽  
Gordon Fuller ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Injury Severity ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Measurable Effect ◽  
Cluster Randomised ◽  
Head Injured ◽  
Secondary Transfer

ObjectiveReconfiguration of trauma services, with direct transport of patients with traumatic brain injury (TBI) to specialist neuroscience centres (SNCs)—bypassing non-specialist acute hospitals (NSAHs), could improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) may worsen outcomes when compared with selective secondary transfer from nearest NSAH to SNC. We conducted a pilot cluster randomised controlled trial to determine the feasibility and plausibility of bypassing suspected patients with TBI —directly into SNCs—producing a measurable effect.SettingTwo English Ambulance Services.Participants74 clusters (ambulance stations) were randomised within pairs after matching for important characteristics. Clusters enrolled head-injured adults—injured nearest to an NSAH—with internationally accepted TBI risk factors and stable ABC. We excluded participants attended by Helicopter Emergency Medical Services or who were injured more than 1 hour by road from nearest SNC.InterventionsIntervention cluster participants were transported directly to an SNC bypassing nearest NSAH; control cluster participants were transported to nearest NSAH with selective secondary transfer to SNC.OutcomesTrial recruitment rate (target n=700 per annum) and percentage with TBI on CT scan (target 80%) were the primary feasibility outcomes. 30-day mortality, 6-month Extended Glasgow Outcome Scale and quality of life were secondary outcomes.Results56 ambulance station clusters recruited 293 patients in 12 months. The trial arms were similar in terms of age, conscious level and injury severity. Less than 25% of recruited patients had TBI on CT (n=70) with 7% (n=20) requiring neurosurgery. Complete case analysis showed similar 30-day mortality in the two trial arms (control=8.8 (2.7–14.0)% vs intervention=9.4(2.3–14.0)%).ConclusionBypassing patients with suspected TBI to SNCs gives an overtriage (false positive) ratio of 13:1 for neurosurgical intervention and 4:1 for TBI. A measurable effect from a full trial of early neuroscience care following bypass is therefore unlikely.Trial registration numberISRCTN68087745.

scholarly journals Broader impacts of an intervention to transform school environments on student behaviour and school functioning: post hoc analyses from the INCLUSIVE cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e031589
Author(s):  
Christopher Bonell ◽  
Matthew Dodd ◽  
Elizabeth Allen ◽  
Leonardo Bevilacqua ◽  
Jennifer McGowan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cigarette Use ◽  
School Environments ◽  
Broader Impacts ◽  
Cluster Randomised ◽  
Disciplinary Procedures ◽  
Aggressive Behaviours ◽  
Post Hoc

BackgroundWe have previously reported benefits for reduced bullying, smoking, alcohol and other drug use and mental health from a trial of ‘Learning Together’, an intervention that aimed to modify school environments and implement restorative practice and a social and emotional skill curriculum.ObjectivesTo conduct post hoc theory-driven analyses of broader impacts.DesignCluster randomised trial.Settings40 state secondary schools in southern England.ParticipantsStudents aged 11/12 years at baseline.OutcomesStudent self-reported measures at 24 and 36 months of: cyberbullying victimisation and perpetration; observations of other students perpetrating aggressive behaviours at school; own perpetration of aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use.ResultsWe found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.ConclusionThese analyses suggested that the intervention was effective in bringing about a broader range of beneficial outcomes, adding to the evidence that the intervention is a promising approach to promote adolescent health via an intervention that is attractive to schools.Trial registration numberISRCTN10751359.

scholarly journals We Can Quit2 (WCQ2): a community-based intervention on smoking cessation for women living in disadvantaged areas of Ireland—study protocol for a pilot cluster randomised controlled trial

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Catherine Hayes ◽  
Aurelia Ciblis ◽  
Catherine Darker ◽  
Nadine Dougall ◽  
Joanne Vance ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Health Service ◽  
Sample Size ◽  
Quantitative Methods ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Pilot Trial ◽  
Cluster Randomised Trial ◽  
Community Based ◽  
Cluster Randomised

Abstract Background Tobacco use is the leading cause of preventable death in Ireland with almost 6000 smokers dying each year from smoking-related diseases. The ‘We Can Quit2’ (WCQ2) study is a pilot pragmatic two-arm, parallel-group, cluster randomised trial that aims to explore the feasibility and acceptability of trial processes including recruitment and to estimate parameters to inform sample size estimates needed for an effectiveness trial. This future trial will assess the effectiveness of a community-based smoking cessation intervention for women living in disadvantaged areas on short- and medium-term cessation rates. Methods/design Four matched pairs of districts (eight clusters) selected by area level of deprivation, geographical proximity, and eligibility for free medical services will be randomised to receive either WCQ (behavioural support + access to Nicotine Replacement Therapy (NRT)) delivered over 12 weeks by trained Community Facilitators (CFs) or to a form of usual care, a one-to-one smoking cessation service delivered by Smoking Cessation Officers from Ireland’s national health service, the Health Service Executive (HSE). Within each cluster, 24–25 women will be recruited (97 per arm; 194 in total) in 4 phases with consent obtained prior to cluster randomisation. The outcome measures will assess feasibility and acceptability of trial processes, including randomisation. Outcome data for a future definitive intervention (biochemically validated smoking abstinence) will be collected at end of programme (12 weeks) and at 6 months. WCQ2 has an embedded process evaluation using both qualitative and quantitative methods. This will be conducted (semi-structured client and CF interviews, intervention delivery checklist, and diary) to explore acceptability of trial processes, intervention fidelity, trial context, and implementation. Trial processes will be assessed against domains of the PRECIS-2 wheel to inform a future definitive trial design. Discussion Data from this pilot trial will inform the design and sample size for a full cluster randomised trial to determine the effectiveness of an intervention tailored to disadvantaged women in improving smoking cessation rates. It will provide transferable learning on the systems and implementation strategies needed to support effective design of future pragmatic community-based trials which address health promotion interventions for women in disadvantaged communities. Trial registration Concurrent to publication. Controlled trials ISRCTN74721694.

scholarly journals Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e023436 ◽  
Author(s):  
Christian Gold ◽  
Jasmin Eickholt ◽  
Jörg Assmus ◽  
Brynjulf Stige ◽  
Jo Dugstad Wake ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Rating Scale ◽  
Controlled Trial ◽  
Elderly Care ◽  
Neuropsychiatric Symptoms ◽  
Care Home ◽  
Randomised Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

IntroductionIn older adults, dementia and depression are associated with individual distress and high societal costs. Music interventions such as group music therapy (GMT) and recreational choir singing (RCS) have shown promising effects, but their comparative effectiveness across clinical subgroups is unknown. This trial aims to determine effectiveness of GMT, RCS and their combination for care home residents and to examine heterogeneity of treatment effects across subgroups.Methods and analysisThis large, pragmatic, multinational cluster-randomised controlled trial with a 2×2 factorial design will compare the effects of GMT, RCS, both or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. We will randomise 100 care home units with ≥1000 residents in total across eight countries. Each intervention will be offered for 6 months (3 months 2 times/week followed by 3 months 1 time/week), with extension allowed if locally available. The primary outcome will be the change in the Montgomery-Åsberg Depression Rating Scale score at 6 months. Secondary outcomes will include depressive symptoms, cognitive functioning, neuropsychiatric symptoms, psychotropic drug use, caregiver burden, quality of life, mortality and costs over at least 12 months. The study has 90% power to detect main effects and is also powered to determine interaction effects with gender, severity and socioeconomic status.Ethics and disseminationEthical approval has been obtained for one country and will be obtained for all countries. Results will be presented at national and international conferences and published in scientific journals.Trial registration numbersNCT03496675; Pre-results, ACTRN12618000156280.

scholarly journals Assessment of the advantage of the serum S100B protein biomonitoring in the management of paediatric mild traumatic brain injury—PROS100B: protocol of a multicentre unblinded stepped wedge cluster randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e027365 ◽  
Author(s):  
Damien Bouvier ◽  
David Balayssac ◽  
Julie Durif ◽  
Charline Mourgues ◽  
Catherine Sarret ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Mild Traumatic Brain Injury ◽  
Randomised Trial ◽  
S100b Protein ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Reference Ranges ◽  
Stepped Wedge ◽  
Serum S100b

IntroductionS100B serum analysis in clinical routine could reduce the number of cranial CT (CCT) scans performed on children with mild traumatic brain injury (mTBI). Sampling should take place within 3 hours of trauma and cut-off levels should be based on paediatric reference ranges. The aim of this study is to evaluate the utility of measuring serum S100B in the management of paediatric mTBI by demonstrating a decrease in the number of CCT scans prescribed in an S100B biomonitoring group compared with a ‘conventional management’ control group, with the assumption of a 30% relative decrease of the number of CCT scans between the two groups.Methods and analysisThe protocol is a randomised, multicentre, unblinded, prospective, interventional study (nine centres) using a stepped wedge cluster design, comparing two groups (S100B biomonitoring and control). Children in the control group will have CCT scans or be hospitalised according to the current recommendations of the French Society of Paediatrics (SFP). In the S100B biomonitoring group, blood sampling to determine serum S100B protein levels will take place within 3 hours after mTBI and subsequent management will depend on the assay. If S100B is in the normal range according to age, the children will be discharged from the emergency department after 6 hours’ observation. If the result is abnormal, CCT scans or hospitalisation will be prescribed in accordance with current SFP recommendations. The primary outcome measure will be the proportion of CCT scans performed (absence/presence of CCT scan for each patient) in the 48 hours following mTBI.Ethics and disseminationThe protocol presented (Version 5, 03 November 2017) has been approved by the ethics committee Comité de Protection des Personnes sud-est 6 (first approval 08 June 2016, IRB: 00008526). Participation in the study is voluntary and anonymous. The study findings will be disseminated in international peer-reviewed journals and presented at relevant conferences.Trial registration numberNCT02819778.

scholarly journals Effectiveness of a peer-led adolescent mental health intervention on HIV virological suppression and mental health in Zimbabwe: protocol of a cluster-randomised trial

2020 ◽  
Vol 7 ◽  
Author(s):  
Silindweyinkosi Chinoda ◽  
Abigail Mutsinze ◽  
Victoria Simms ◽  
Rhulani Beji-Chauke ◽  
Ruth Verhey ◽  
...  
Keyword(s):  
Mental Health ◽  
Common Mental Disorder ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Well Being ◽  
Virological Suppression ◽  
Cluster Randomised Trial ◽  
Depression Symptoms ◽  
Cluster Randomised ◽  
Living With Hiv

Abstract Background Adolescents living with HIV (ALHIV) experience a high burden of mental health disorder which is a barrier to antiretroviral therapy adherence. In Zimbabwe, trained, mentored peer supporters living with HIV (Community Adolescent Treatment Supporters – CATS) have been found to improve adherence, viral suppression and psychosocial well-being among ALHIV. The Friendship Bench is the largest integrated mental health programme in Africa. We hypothesise that combining the CATS programme and Friendship Bench will improve mental health and virological suppression among ALHIV compared with the CATS programme alone. Methods We will conduct a cluster-randomised controlled trial in 60 clinics randomised 1:1 in five provinces. ALHIV attending the control arm clinics will receive standard CATS support and clinic support following the Ministry of Health guidelines. Those attending the intervention arm clinics will receive Friendship Bench problem-solving therapy, delivered by trained CATS. Participants with the signs of psychological distress will be referred to the clinic for further assessment and management. The primary outcome is HIV virological failure (≥1000 copies/ml) or death at 48 weeks. Secondary outcomes include the proportion of adolescents with common mental disorder symptoms (defined as Shona Symptom Questionnaire (SSQ-14) score ≥8), proportion with depression symptoms (defined as Patient Health Questionnaire (PHQ-9) score ≥11), symptom severity (mean SSQ-14 and PHQ-9 scores) and EQ-5D score for health-related quality of life. Conclusions This trial evaluates the effectiveness of peer-delivery of mental health care on mental health and HIV viral load among ALHIV. If effective this intervention has the potential to be scaled-up to improve these outcomes. Trial registration: PACTR201810756862405. 08 October 2018.

scholarly journals Effectiveness of conditional cash transfers (Afya credits incentive) to retain women in the continuum of care during pregnancy, birth and the postnatal period in Kenya: a cluster-randomised trial

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e055921
Author(s):  
Fedra Vanhuyse ◽  
Oliver Stirrup ◽  
Aloyce Odhiambo ◽  
Tom Palmer ◽  
Sarah Dickin ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Electronic System ◽  
Continuum Of Care ◽  
Cash Transfers ◽  
Conditional Cash Transfers ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
The Impact ◽  
The Continuum

ObjectivesGiven high maternal and child mortality rates, we assessed the impact of conditional cash transfers (CCTs) to retain women in the continuum of care (antenatal care (ANC), delivery at facility, postnatal care (PNC) and child immunisation).DesignWe conducted an unblinded 1:1 cluster-randomised controlled trial.Setting48 health facilities in Siaya County, Kenya were randomised. The trial ran from May 2017 to December 2019.Participants2922 women were recruited to the control and 2522 to the intervention arm.InterventionsAn electronic system recorded attendance and triggered payments to the participant’s mobile for the intervention arm (US$4.5), and phone credit for the control arm (US$0.5). Eligibility criteria were resident in the catchment area and access to a mobile phone.Primary outcomesPrimary outcomes were any ANC, delivery, any PNC between 4 and 12 months after delivery, childhood immunisation and referral attendance to other facilities for ANC or PNC. Given problems with the electronic system, primary outcomes were obtained from maternal clinic books if participants brought them to data extraction meetings (1257 (50%) of intervention and 1053 (36%) control arm participants). Attendance at referrals to other facilities is not reported because of limited data.ResultsWe found a significantly higher proportion of appointments attended for ANC (67% vs 60%, adjusted OR (aOR) 1.90; 95% CI 1.36 to 2.66) and child immunisation (88% vs 85%; aOR 1.74; 95% CI 1.10 to 2.77) in intervention than control arm. No intervention effect was seen considering delivery at the facility (90% vs 92%; aOR 0.58; 95% CI 0.25 to 1.33) and any PNC attendance (82% vs 81%; aOR 1.25; 95% CI 0.74 to 2.10) separately. The pooled OR across all attendance types was 1.64 (1.28 to 2.10).ConclusionsDemand-side financing incentives, such as CCTs, can improve attendance for appointments. However, attention needs to be paid to the technology, the barriers that remain for delivery at facility and PNC visits and encouraging women to attend ANC visits within the recommended WHO timeframe.Trial registrationNCT03021070.

scholarly journals Protocol for a cluster randomised trial to evaluate a community level complementary food safety and hygiene and nutrition intervention in Mali: The MaaCiwara study

2021 ◽  
Author(s):  
Samuel I Watson ◽  
Evans A Asamane ◽  
Richard J Lilford ◽  
Karla Hemming ◽  
Cheick Sidibe ◽  
...  
Keyword(s):  
Food Safety ◽  
Structural Equation ◽  
Diarrheal Disease ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Complementary Food ◽  
Cluster Randomised Trial ◽  
Enteric Infection ◽  
Community Based ◽  
Cluster Randomised

Background Diarrheal disease remains a significant cause of morbidity and mortality among the under-fives in many low- and middle-income countries. Changes to food safety practices and feeding methods around the weaning period, alongside improved nutrition, may significantly reduce the risk of disease and improve development for infants. This article describes a protocol for a cluster randomized trial to evaluate the effectiveness of a multi-faceted community-based educational intervention that aims to improve food safety and hygiene behaviours and enhance child nutrition. Methods We will conduct a mixed-methods, parallel cluster randomised controlled trial with baseline measures. 120 clusters comprising small urban and rural communities will be recruited in equal numbers and randomly allocated in a 1:1 ratio to either treatment or control arms. Participants will be mother-child dyads (27 per cluster period) with children aged 6 to 24 months. Data collection will comprise a day of observation and interviews with each participating mother-child pair and will take place at baseline and four and 15 months post-intervention. The primary analysis will estimate the effectiveness of the intervention on changes to complementary food safety and preparation behaviours, food and water contamination, and diarrhoea. Secondary outcomes include maternal autonomy, enteric infection, nutritional content of meals, and child anthropometry. A secondary structural equation analysis will be conducted to examine the causal relationships between the different outcomes. Conclusions The trial will provide evidence on the effectiveness of community-based behavioural change and educational interventions designed to reduce the burden of diarrhoeal disease in the under fives, and how effectiveness varies across different contexts.

scholarly journals Protocol for a cluster randomised trial in Madhya Pradesh, India: Community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2)

2020 ◽  
Author(s):  
Arjun Agarwal ◽  
Rukmini Banerji ◽  
Peter Boone ◽  
Diana Elbourne ◽  
Ila Fazzio ◽  
...  
Keyword(s):  
Community Health ◽  
Rural Areas ◽  
Controlled Trial ◽  
Health Centre ◽  
Randomised Trial ◽  
First Grade ◽  
Madhya Pradesh ◽  
Cluster Randomised Trial ◽  
Education Intervention ◽  
Cluster Randomised

Abstract Background Rural areas of India exhibit high neonatal mortality, and low literacy and numeracy. We assess the effect of a complex package of health interventions on neonatal survival, and the effect of out-of-school-hours teaching on children’s literacy and numeracy, in rural Madhya Pradesh. Methods/Design This is a cluster-randomised controlled trial with villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial villages receiving the health intervention are controls for the education intervention, and vice versa. Clusters 196 villages in Satna district, Madhya Pradesh, India: each at least five kilometres from a Community Health Centre, a population below 2,500, and at least 15 children eligible for the education intervention. Participants CHAMPION2 - resident married women under 50 without a family planning operation, provided they are enumerated pre-randomisation, or marry a man enumerated pre-randomisation. STRIPES2 - resident children born 16June 2010-15June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020.

scholarly journals The contribution of injury severity, executive and implicit functions to awareness of deficits after traumatic brain injury (TBI)

2010 ◽  
Vol 16 (6) ◽  
pp. 1089-1098 ◽  
Author(s):  
NICHOLAS MORTON ◽  
LYNNE BARKER
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Injury Severity ◽  
Mood State ◽  
Hierarchical Regression ◽  
Implicit Measures ◽  
Implicit Functions ◽  
Severe Injuries ◽  
Severity Of Injury ◽  
Head Injured

AbstractDeficits in self-awareness are commonly seen after Traumatic Brain Injury (TBI) and adversely affect rehabilitative efforts, independence and quality of life (Ponsford, 2004). Awareness models predict that executive and implicit functions are important cognitive components of awareness though the putative relationship between implicit and awareness processes has not been subject to empirical investigation (Crosson et al., 1989; Ownsworth, Clare, & Morris, 2006; Toglia & Kirk, 2000). Severity of injury, also thought to be a crucial determinant of awareness outcome post-insult, is under-explored in awareness studies (Sherer, Boake, Levin, Silver, Ringholz, & Walter, 1998). The present study measured the contribution of injury severity, IQ, mood state, executive and implicit functions to awareness in head-injured patients assigned to moderate/severe head-injured groups using several awareness, executive, and implicit measures. Severe injuries resulted in greater impairments across most awareness, executive and implicit measures compared with moderate injuries, although deficits were still seen in the moderate group. Hierarchical regression results showed that severity of injury, IQ, mood state, executive and implicit functions made significant unique contributions to selective aspects of awareness. Future models of awareness should account for both implicit and executive contributions to awareness and the possibility that both are vulnerable to disruption after neuropathology. (JINS, 2010,16, 1089–1098.)

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