scholarly journals Neurally-Adjusted Ventilatory Assist (NAVA) versus Pneumatically Synchronized Ventilation Modes in Children Admitted to PICU

2021 ◽  
Vol 10 (15) ◽  
pp. 3393
Author(s):  
Pravin Sugunan ◽  
Osama Hosheh ◽  
Mireia Garcia Cusco ◽  
Reinout Mildner
Keyword(s):  
Cohort Study ◽  
Length Of Stay ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Neurally Adjusted Ventilatory Assist ◽  
Respiratory Drive ◽  
Ventilatory Assist ◽  
Ventilation Modes ◽  
Randomised Controlled ◽  
Duration Of Ventilation

Traditionally, invasively ventilated children in the paediatric intensive care unit (PICU) are weaned using pneumatically-triggered ventilation modes with a fixed level of assist. The best weaning mode is currently not known. Neurally adjusted ventilatory assist (NAVA), a newer weaning mode, uses the electrical activity of the diaphragm (Edi) to synchronise ventilator support proportionally to the patient’s respiratory drive. We aimed to perform a systematic literature review to assess the effect of NAVA on clinical outcomes in invasively ventilated children with non-neonatal lung disease. Three studies (n = 285) were included for analysis. One randomised controlled trial (RCT) of all comers showed a significant reduction in PICU length of stay and sedative use. A cohort study of acute respiratory distress syndrome (ARDS) patients (n = 30) showed a significantly shorter duration of ventilation and improved sedation with the use of NAVA. A cohort study of children recovering from cardiac surgery (n = 75) showed significantly higher extubation success, shorter duration of ventilation and PICU length of stay, and a reduction in sedative use. Our systematic review presents weak evidence that NAVA may shorten the duration of ventilation and PICU length of stay, and reduce the requirement of sedatives. However, further RCTs are required to more fully assess the effect of NAVA on clinical outcomes and treatment costs in ventilated children.

scholarly journals Metformin reduces 12-month change in body weight among people newly commenced on clozapine: a retrospective naturalistic cohort study

2021 ◽  
Vol 11 ◽  
pp. 204512532110006
Author(s):  
Jessica Spokes ◽  
Samantha Hollingworth ◽  
Karl Winckel ◽  
Steve Kisely ◽  
Andrea Baker ◽  
...  
Keyword(s):  
Cohort Study ◽  
Weight Gain ◽  
Tobacco Smoking ◽  
Digital Health ◽  
Controlled Trial ◽  
Bodyweight Gain ◽  
Metabolic Effects ◽  
Secondary Outcome ◽  
Standard Clinical Practice ◽  
Randomised Controlled

Background: People with schizophrenia have a 15–20-year reduction in life expectancy, driven in part by the metabolic effects of antipsychotics. Clozapine is associated with the highest rates of weight gain. As clozapine remains the most effective antipsychotic for treatment-resistant schizophrenia (TRS), identifying treatments to ameliorate clozapine-induced weight gain (CIWG) is urgently needed to reduce this morality gap. Methods: We retrospectively analysed digital health records of patients with TRS aged 18–65 newly initiated on clozapine at four tertiary hospitals in south-east Queensland from 1 March 2017 to 30 June 2019. Our primary outcome was the effect of metformin on change in percentage bodyweight at 12 months after clozapine initiation, with secondary outcome being proportion with >5% or >7% bodyweight change. We also explored impact on bodyweight change of other variables including sex, tobacco smoking, type 2 diabetes (T2DM), age, clozapine level and dose and clozapine/norclozapine ratio. Results: Among 90 patients initiated on clozapine, metformin use ( n = 48) was associated with a smaller increase in percentage bodyweight (1.32% versus 5.95%, p = 0.031), lower rates of >7% gain in bodyweight (37.8% versus 63.0%, p = 0.025) but not >5% gain in bodyweight. Age below the median (32.0 years) was associated with greater bodyweight gain (5.55% versus 1.22%, p = 0.046). Sex, tobacco smoking, T2DM, clozapine dose and level and clozapine/norclozapine ratio were not associated with differences in change in bodyweight. Conclusion: In this small retrospective cohort study, use of metformin within 12-months of clozapine initiation was associated with a statistically and clinically significant reduction in CIWG. Although there is increasing evidence for the role of metformin to ameliorate bodyweight gain at time of clozapine initiation, our findings need replication and testing in a randomised controlled trial before recommending metformin co-commencement with clozapine as standard clinical practice.

scholarly journals Supporting Parents & Kids Through Lockdown Experiences (SPARKLE): A digital parenting support app implemented in an ongoing general population cohort study during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Katarzyna Kostyrka-Allchorne ◽  
Cathy Creswell ◽  
Sarah Byford ◽  
Crispin Day ◽  
Kimberley Goldsmith ◽  
...  
Keyword(s):  
Cohort Study ◽  
Conduct Problems ◽  
Controlled Trial ◽  
Child Conduct Problems ◽  
Parenting Support ◽  
Parent Outcomes ◽  
Full Protocol ◽  
Children’S Behaviour ◽  
Randomised Controlled

Abstract Objectives The COVID-19 related lockdowns and distancing measures have presented families with unprecedented challenges. A UK-wide cohort study tracking changes in families’ mental health since early lockdown (Co-SPACE) found a significant rise in primary school-aged children’s behaviour problems and associated family-related stress. Three-quarters of parents in Co-SPACE also reported wanting extra support. In SPARKLE, we will examine whether providing Co-SPACE families with a smartphone application delivering information and parenting support, Parent Positive, can reverse the negative effects of the pandemic on children and parents. The efficacy on child and parent outcomes and cost-effectiveness of Parent Positive will be examined. We will also test whether the effects are moderated by pre-existing levels of child conduct problems and usage of Parent Positive. Exploratory analyses will examine whether other baseline characteristics or lockdown circumstances moderate the effects of Parent Positive. Trial design SPARKLE is a two-arm superiority parallel group randomised controlled trial embedded in an existing large UK-wide self-selected community cohort – Co-SPACE. Those who consent to SPARKLE will be randomised 1:1 to either Parent Positive or Follow-up As Usual (FAU). Participants Co-SPACE (a UK-wide longitudinal cohort study) parents aged ≥18 who have children aged 4-10 years will be eligible for SPARKLE. Intervention and comparator Parent Positive: is a digital public health intervention that can be delivered rapidly at scale to support parents in managing their children’s behaviour to reduce conduct problems and levels of family conflict, which were exacerbated during the first lockdown, and which may increase further in future months as families need to cope with continuous uncertainty and further disruption to their daily lives. Co-designed with parents and based on decades of parenting research, Parent Positive consists of three elements: (i) Parenting Boosters: where advice, delivered in the form of narrated animations, videos, graphics and text is provided to help parents with eight common parenting challenges; (ii) Parenting Exchange: a facilitated parent-to-parent communication and peer support platform and; (iii) Parent Resources: giving access to carefully selected high-quality, evidence-based online parenting resources. Follow-up as Usual: FAU was selected as a comparator because the public health nature meant that an active comparator was not appropriate due to the pragmatic, rapid implementation of the trial. Individuals randomised to FAU will receive no intervention for the first two months while the data for baseline (T1), T2 and T3 are collected. They will then be given full access to the app until 30th November 2021. Main outcomes Outcome measures will be collected remotely through Qualtrics according to the Co-SPACE schedule at baseline (T1), which will be the Co-SPACE survey data obtained immediately prior to randomisation, and then at one month (T2) and two months (T3) post-randomisation. Measures will be collected to assess group differences in child and parent outcomes, costs and service utilisation, and adverse events. Usage of Parent Positive will also be tracked. The primary outcome is parent-reported child conduct problems at one-month post-randomisation measured using the Strengths and Difficulties Questionnaire conduct problems subscale. Randomisation Enrolled participants will be allocated to Parent Positive or FAU at the ratio of 1:1 by simple randomisation using the Randomizer function within the Qualtrics programme. Neither blocking nor stratification will be used. Blinding (masking) It is not possible to blind parents enrolled in the study and Qualtrics will automatically inform parents of their group allocation. Blinded members of the research team and the senior statistician will not be given access to the Qualtrics system or the data in order to remain blinded until after the analysis is complete. We do not anticipate any serious harms associated with taking part in the intervention, therefore there will be no need to unblind any blinded staff during the study. The junior statistician will be unblinded throughout. Numbers to be randomised (sample size) A total of 616 will be recruited into the trial with 308 consenting parents randomised to each treatment arm. Trial status V1.0; 15.03.2021. Not yet recruiting. Anticipated start date: 1st April 2021. Anticipated end date for recruitment: 31st July 2021. Trial registration Clinicaltrial.gov: NCT04786080. The trial was prospectively registered on 8 March 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

scholarly journals Mixed methods pilot evaluation of interpersonal psychotherapy for body image for adolescents

2020 ◽  
pp. 135910452096337
Author(s):  
Fiona Duffy ◽  
Helen Sharpe ◽  
Emily Beveridge ◽  
Kate Osborne ◽  
Cathy Richards
Keyword(s):  
Body Image ◽  
Young People ◽  
Body Dissatisfaction ◽  
Clinical Outcomes ◽  
Group Intervention ◽  
Treatment Satisfaction ◽  
Controlled Trial ◽  
Interpersonal Psychotherapy ◽  
Post Intervention ◽  
Randomised Controlled

Body dissatisfaction is common in adolescence and associated with poor outcomes. The aim of this mixed method pilot evaluation was to determine acceptability, feasibility and preliminary efficacy of Interpersonal Psychotherapy for Body Image (IPT-BI), a school-based group intervention for young people with high levels of body dissatisfaction. Eighteen participants (11–13 years, 78% female) took part in two IPT-BI groups ( n = 10; n = 8). Feasibility was measured by recruitment and attrition rates; acceptability using a treatment satisfaction questionnaire and focus groups; and clinical outcomes at baseline, each session and post intervention. The majority of young people (72%, n = 18/25) who were referred or expressed interest went on to take part. Average session attendance was 100% and 89%. Participants expressed high levels of treatment satisfaction with 94% ( n = 16/17) rating IPT-BI as ‘quite helpful’ or ‘very helpful’ and 94% ( n = 16/17) stating they would recommend it to others. Preliminary exploration of efficacy showed significant improvements in body image and significant reductions in interpersonal difficulties and appearance-based conversations. Young people valued specific IPT-BI skills (role play, communication strategies), alongside generic therapeutic factors (therapeutic alliance, group cohesion). IPT-BI is feasible and acceptable with promising provisional clinical outcomes indicating the need for a fully powered randomised controlled trial.

scholarly journals Clinical outcomes of colistin in combination with either 6-g sulbactam or carbapenems for the treatment of extensively drug-resistant Acinetobacter baumannii pneumonia with high MIC to sulbactam, a prospective cohort study

2019 ◽  
Author(s):  
Chutchawan Ungthammakhun ◽  
Vasin Vasikasin ◽  
Dhitiwat Changpradub
Keyword(s):  
Cohort Study ◽  
Length Of Stay ◽  
Acinetobacter Baumannii ◽  
Clinical Outcomes ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Mortality Rates ◽  
P Value ◽  
Drug Resistant ◽  
Extensively Drug Resistant

Abstract Background: Extensively drug-resistant Acinetobacter baumannii (XDRAB) is an important cause of nosocomial pneumonia with limited therapeutic options. Colistin based regimen is recommended treatment. Which drugs should be combined with colistin remains uncertain. The aim of this study was to investigate the clinical outcomes of patients with XDRAB pneumonia who were treated with colistin, combined with either 6-g sulbactam or carbapenems, in the setting of high MIC to sulbactam. Methods: In this prospective cohort study, hospitalized patients diagnosed with XDRAB pneumonia in Phramongkutklao Hospital were enrolled. The primary outcome was the 28-day mortality. Secondary outcomes were 7 and 14-day mortality, length of stay, ventilator days and factors associated with mortality. Results: From 1 July 2016 to 30 September 2017, 192 patients were included; 92 received colistin plus sulbactam and 90 received colistin plus carbapenems. Most of the patients were male diagnosed with ventilator associated pneumonia in medical intensive care unit. Overall mortality rates at 7, 14, 28 days were 24.2%, 37.4%, 53.3%, respectively. Mortality rates did not differ between sulbactam group and carbapenems groups at 7 days (19.6% vs. 28.9%, p-value 0.424, adjusted HR 1.277; 95% CI = 0.702-2.322), 14 days (34.8% vs. 40%, p = 0.658, adjusted HR 1.109; 95% CI = 0.703-1.749) and 28 days (51.1% vs. 55.6%, p = 0.857, adjusted HR 1.038; 95% CI = 0.690-1.562). Length of stay, ICU days and ventilator days did not differ. Complications of treatment including acute kidney injury were not statistically different. Conclusions: In XDRAB pneumonia with high MIC to sulbactam, mortality rates were not statistically significant between colistin plus 6-g sulbactam and colistin plus carbapenems. Keywords: XDR A. baumannii pneumonia, mortality rate, colistin based, sulbactam, carbapenems

Longer-Term Clinical and Economic Benefits of Offering Acupuncture to Patients with Chronic Low Back Pain Assessed as Suitable for Primary Care Management – 3 Month Clinical Outcomes from a Controlled Trial of 241 Patients

2002 ◽  
Vol 20 (2-3) ◽  
pp. 121-137
Author(s):  
H Macpherson ◽  
K Thomas ◽  
J Brazier ◽  
M Fitter ◽  
L Thorpe ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Bodily Pain ◽  
Control Group ◽  
Low Back ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Objectives To undertake a pragmatic randomised controlled trial to test the hypothesis that a population of patients with persistent low back pain, when given access to an acupuncture service, gain more relief from pain than those offered usual management only, for equal or less cost. Methods The study is a pragmatic randomised controlled trial (n=241). Suitable patients are identified by their general practitioners. Patients randomised to the experimental arm are offered the option of referral for up to 10 individualised treatments from one of six qualified acupuncture practitioners. The control group continues to receive usual management from their general practitioner. The primary scale used for measuring change is the Bodily Pain (SF–36) at 3 months and 12 months post randomisation. The main outcome is cost-effectiveness at 12 months. Results A total of 43 general practitioners participated in the trial and 241 patients were randomised. All patients randomised to the option of acupuncture chose to receive treatment. Clinical outcomes at 3 months show that the SF-36 Bodily Pain scores improved by 29.4 and 24.9 points in the acupuncture and normal management group respectively (p=0.125). Patients in the acupuncture group reported lower levels of worry at three months (p<0.001). Conclusions It is possible to conduct a large pragmatic randomised controlled trial of acupuncture in a primary care setting. Acupuncture is seen as an acceptable treatment by patients with low back pain. Clinical outcomes at three months suggest that the acupuncture group are in less pain than the control group.

Sign in / Sign up

Export Citation Format

Share Document