scholarly journals Mediation effects that emulate a target randomised trial: Simulation-based evaluation of ill-defined interventions on multiple mediators

2021 ◽  
pp. 096228022199840
Author(s):  
Margarita Moreno-Betancur ◽  
Paul Moran ◽  
Denise Becker ◽  
George C Patton ◽  
John B Carlin
Keyword(s):  
Randomised Trial ◽  
Depression Symptoms ◽  
Computation Method ◽  
Target Trial ◽  
Level Of Evidence ◽  
Mediation Effects ◽  
Simulation Based ◽  
Causal Assumptions ◽  
Self Harm ◽  
Health Cohort Study

Many epidemiological questions concern potential interventions to alter the pathways presumed to mediate an association. For example, we consider a study that investigates the benefit of interventions in young adulthood for ameliorating the poorer mid-life psychosocial outcomes of adolescent self-harmers relative to their healthy peers. Two methodological challenges arise. First, mediation methods have hitherto mostly focused on the elusive task of discovering pathways, rather than on the evaluation of mediator interventions. Second, the complexity of such questions is invariably such that there are no well-defined mediator interventions (i.e. actual treatments, programs, etc.) for which data exist on the relevant populations, outcomes and time-spans of interest. Instead, researchers must rely on exposure (non-intervention) data, that is, on mediator measures such as depression symptoms for which the actual interventions that one might implement to alter them are not well defined. We propose a novel framework that addresses these challenges by defining mediation effects that map to a target trial of hypothetical interventions targeting multiple mediators for which we simulate the effects. Specifically, we specify a target trial addressing three policy-relevant questions, regarding the impacts of hypothetical interventions that would shift the mediators’ distributions (separately under various interdependence assumptions, jointly or sequentially) to user-specified distributions that can be emulated with the observed data. We then define novel interventional effects that map to this trial, simulating shifts by setting mediators to random draws from those distributions. We show that estimation using a g-computation method is possible under an expanded set of causal assumptions relative to inference with well-defined interventions, which reflects the lower level of evidence that is expected with ill-defined interventions. Application to the self-harm example in the Victorian Adolescent Health Cohort Study illustrates the value of our proposal for informing the design and evaluation of actual interventions in the future.

scholarly journals Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial

2012 ◽  
Vol 167 (2) ◽  
pp. 287-294 ◽  
Author(s):  
Leo Niskanen ◽  
Lawrence A Leiter ◽  
Edward Franek ◽  
Jianping Weng ◽  
Taner Damci ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Aspart ◽  
Randomised Trial ◽  
Insulin Degludec ◽  
Treat To Target ◽  
Target Trial ◽  
Open Label ◽  
Biphasic Insulin ◽  
Biphasic Insulin Aspart 30

ObjectiveInsulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of insulin degludec (70%) and insulin aspart (IAsp: 30%). Here, we compare the efficacy and safety of IDegAsp, an alternative IDegAsp formulation (AF: containing 45% IAsp), and biphasic IAsp 30 (BIAsp 30).DesignSixteen-week, open-label, randomised, treat-to-target trial.MethodsInsulin-naive subjects with type 2 diabetes (18–75 years) and a HbA1c of 7–11% were randomised to twice-daily IDegAsp (n=61), AF (n=59) or BIAsp 30 (n=62), all in combination with metformin. Insulin was administered pre-breakfast and dinner (main evening meal) and titrated to pre-breakfast and pre-dinner plasma glucose (PG) targets of 4.0–6.0 mmol/l.ResultsMean HbA1c after 16 weeks was comparable for IDegAsp, AF and BIAsp 30 (6.7, 6.6 and 6.7% respectively). With IDegAsp, 67% of subjects achieved HbA1c <7.0% without confirmed hypoglycaemia in the last 4 weeks of treatment compared with 53% (AF) and 40% (BIAsp 30). Mean fasting PG was significantly lower for IDegAsp vs BIAsp 30 (treatment difference (TD): −0.99 mmol/l (95% confidence interval: −1.68; 0.29)) and AF vs BIAsp 30 (TD: −0.88 mmol/l (−1.58; −0.18)). A significant, 58% lower rate of confirmed hypoglycaemia was found for IDegAsp vs BIAsp 30 (rate ratio (RR): 0.42 (0.23; 0.75)); rates were similar for AF vs BIAsp 30 (RR: 0.92 (0.54; 1.57)). IDegAsp and AF had numerically lower rates of nocturnal confirmed hypoglycaemia vs BIAsp 30 (RR: 0.33 (0.09; 1.14) and 0.66 (0.22; 1.93) respectively).ConclusionsIDegAsp provided comparable overall glycaemic control to BIAsp 30 with a significantly lower rate of hypoglycaemia.

Video Tutorials Increase Precision in Minimally Invasive Surgery Training – a Prospective Randomised Trial and Follow-up Study

2018 ◽  
Vol 144 (02) ◽  
pp. 153-162
Author(s):  
Michael Thomaschewski ◽  
Hamed Esnaashari ◽  
Anna Höfer ◽  
Lotta Renner ◽  
Claudia Benecke ◽  
...  
Keyword(s):  
Minimally Invasive Surgery ◽  
Minimally Invasive ◽  
Invasive Surgery ◽  
Randomised Trial ◽  
Prospective Randomised Trial ◽  
Simulation Based ◽  
Video Tutorials ◽  
Group A ◽  
Group B

Abstract Background Simulation-based practice has become increasingly important in minimally invasive surgery (MIS) training. Nevertheless, personnel resources for demonstration and mentoring simulation-based practice are limited. Video tutorials could be a useful tool to overcome this dilemma. However, the effect of video tutorials on MIS training and improvement of MIS skills is unclear. Methods A prospective randomised trial (n = 24 MIS novices) was conducted. A video-trainer with three different tasks (#1 – 3) was used for standardised goal-directed MIS training. The subjects were randomised to two groups with standard instructional videos (group A, n = 12) versus comprehensive video tutorials for each training task watched at specific times of repetition (group B, n = 12). Performance was analysed using the MISTELS score. At the beginning and following the curriculum, an MIS cholecystectomy (CHE) was performed on a porcine organ model and analysed using the GOALS score. After 18 weeks, participants performed 10 repetitions of tasks #1 – 3 for follow-up analysis. Results More participants completed tasks #1 and #2 in group B (83.3 and 75%) than in group A (66.7 and 50%, ns). For task #2, there was a significant improvement in precision in group B (p < 0.001). For the entire cohort, the GOALS-Scores were 12.9 before and 18.9 after the curriculum (p < 0.001), with no significant difference between groups. Upon follow-up, 84.2% (task#1), 26.3% (task#2) and 100% (task#3) of MIS novices were able to reach the defined goals (A vs. B ns). There was a trend for a better MISTELS score in group B upon follow-up. Conclusions Standardised comprehensive video tutorials watched frequently throughout practice can significantly improve precision in MIC training. This aspect should be incorporated in MIS training.

A systematic review of evidence-based aftercare for older adults following self-harm

2022 ◽  
pp. 000486742110671
Author(s):  
Anne PF Wand ◽  
Roisin Browne ◽  
Tiffany Jessop ◽  
Carmelle Peisah
Keyword(s):  
Older Adults ◽  
Qualitative Studies ◽  
Assessment Tools ◽  
Screening Tools ◽  
Safety Planning ◽  
Level Of Evidence ◽  
Heritage Foundation ◽  
Quality Ratings ◽  
Self Harm

Objective: Self-harm is closely associated with suicide in older adults and may provide opportunity to intervene to prevent suicide. This study aimed to systematically review recent evidence for three components of aftercare for older adults: (1) referral pathways, (2) assessment tools and safety planning approaches and (3) engagement and intervention strategies. Methods: Databases PubMed, Medline, PsychINFO, Embase and CINAHL were searched from January 2010 to 10 July 2021 by two reviewers. Empirical studies reporting aftercare interventions for older adults (aged 60+) following self-harm (including with suicidal intent) were included. Full text of articles with abstracts meeting inclusion criteria were obtained and independently reviewed by three authors to determine final studies for review. Two reviewers extracted data and assessed level of evidence (Oxford) and quality ratings (Alberta Heritage Foundation for Medical Research Standard Quality Assessment Criteria for quantitative and Attree and Milton checklist for qualitative studies), working independently. Results: Twenty studies were reviewed (15 quantitative; 5 qualitative). Levels of evidence were low (3, 4), and quality ratings of quantitative studies variable, although qualitative studies rated highly. Most studies of referral pathways were observational and demonstrated marked variation with no clear guidelines or imperatives for community psychiatric follow-up. Of four screening tools evaluated, three were suicide-specific and one screened for depression. An evidence-informed approach to safety planning was described using cases. Strategies for aftercare engagement and intervention included two multifaceted approaches, psychotherapy and qualitative insights from older people who self-harmed, carers and clinicians. The qualitative studies identified targets for improved aftercare engagement, focused on individual context, experiences and needs. Conclusion: Dedicated older-adult aftercare interventions with a multifaceted, assertive follow-up approach accompanied by systemic change show promise but require further evaluation. Research is needed to explore the utility of needs assessment compared to screening and evaluate efficacy of safety planning and psychotherapeutic approaches.

Knowledge transfer and retention of simulation-based learning for neurosurgical instruments: a randomised trial of perioperative nurses

2020 ◽  
pp. bmjstel-2019-000576
Author(s):  
David B Clarke ◽  
Alena I Galilee ◽  
Nelofar Kureshi ◽  
Murray Hong ◽  
Lynne Fenerty ◽  
...  
Keyword(s):  
Nursing Education ◽  
Simulation Training ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Control Group ◽  
Perioperative Nurses ◽  
Instrument Recognition ◽  
Simulation Based ◽  
Group A ◽  
Group B

IntroductionPrevious studies have shown that simulation is an acceptable method of training in nursing education. The objectives of this study were to determine the effectiveness of tablet-based simulation in learning neurosurgical instruments and to assess whether skills learnt in the simulation environment are transferred to a real clinical task and retained over time.MethodsA randomised controlled trial was conducted. Perioperative nurses completed three consecutive sessions of a simulation. Group A performed simulation tasks prior to identifying real instruments, whereas Group B (control group) was asked to identify real instruments prior to the simulation tasks. Both groups were reassessed for knowledge recall after 1 week.ResultsNinety-three nurses completed the study. Participants in Group A, who had received tablet-based simulation, were 23% quicker in identifying real instruments and did so with better accuracy (93.2% vs 80.6%, p<0.0001) than Group B. Furthermore, the simulation-based learning was retained at 7 days with 97.8% correct instrument recognition in Group A and 96.2% in Group B while maintaining both speed and accuracy.ConclusionThis is the first study to assess the effectiveness of tablet-based simulation training for instrument recognition by perioperative nurses. Our results demonstrate that instrument knowledge acquired through tablet-based simulation training results in improved identification and retained recognition of real instruments.

scholarly journals Effect of Implementing Simulation Education on Health Care Worker Comfort With Nasopharyngeal Swabbing for COVID-19

2020 ◽  
Vol 163 (2) ◽  
pp. 271-274 ◽  
Author(s):  
Michelle E. Mark ◽  
Phillip LoSavio ◽  
Inna Husain ◽  
Peter Papagiannopoulos ◽  
Pete S. Batra ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Workers ◽  
Simulation Training ◽  
False Negative ◽  
Nasopharyngeal Swab ◽  
Level Of Evidence ◽  
Improve Health Care ◽  
Care Workers ◽  
Simulation Based ◽  
Improve Health

Objective To determine if rapid implementation of simulation training for the nasopharyngeal swab procedure can increase provider confidence regarding procedure competency. Methods A simulation training exercise was designed as a departmental initiative to improve competency performing nasopharyngeal swabs during the COVID-19 pandemic. Sixty-one health care workers attended teaching sessions led by the Department of Otorhinolaryngology on proper nasopharyngeal swab technique. After a brief lecture, participants practiced their swab technique using a high-fidelity airway simulation model. Pre- and postintervention self-evaluations were measured via standardized clinical competency questionnaires on a 5-point Likert scale ranging from “No knowledge, unable to perform” up to “Highly knowledgeable and confident, independent.” Results Forty-six participants in this study submitted pre- and postintervention self-assessments. Postintervention scores improved on average 1.41 points (95% CI, 1.10-1.73) out of 5 from a mean score of 3.13 to 4.54 ( P < .0001). This reflects a large effect size with a Glass’s delta value of 1.3. Discussion Lecture coupled with simulation-based teaching can significantly improve health care workers’ confidence in performing nasopharyngeal swabs. Proper training for frontline workers performing swabs for COVID-19 is essential to improving testing accuracy and can be achieved in a simple and timely manner. Implications for Practice To meet the testing needs of the growing pandemic, many health care workers who are unfamiliar with nasopharyngeal swabs have been asked to perform this test. Simulation-based teaching sessions may improve health care workers’ confidence and help prevent false-negative results. This intervention is easily reproducible in any setting where frequent nasopharyngeal swab testing occurs. Level of Evidence/Study Design Prospective cohort study.

A FAST COMPUTATION METHOD FOR SOFT TISSUE DEFORMATIONS SIMULATION BASED ON SELF-SELECTION ALGORITHM FOR EMBEDDED OPERATING AREA

2017 ◽  
Vol 17 (07) ◽  
pp. 1740016
Author(s):  
MONAN WANG ◽  
ZHIYONG MAO ◽  
XIANJUN AN
Keyword(s):  
Soft Tissue ◽  
Soft Tissues ◽  
Nonlinear Problems ◽  
Rectus Femoris ◽  
Computation Method ◽  
Biomechanical Models ◽  
Simulation Based ◽  
Material Nonlinear ◽  
Tissue Deformations ◽  
Tissue Models

This study used biomechanical models of soft tissues based on combined exponential and polynomial models. Finite element methods were used to solve material nonlinear and geometrically nonlinear problems of soft tissue models. This involved assigning a screening coefficient in the model-accelerated computing process to filter the units involved in the calculation. The screening coefficient controlled both the accuracy of the results of simulation and the computing speed through setting up a subset of finite elements. The fast computer method based on the screening coefficient was applied to the rectus femoris simulation.

scholarly journals Depressive symptoms and neuroticism-related traits are the main factors associated with wellbeing independent of the history of lifetime depression in the UK Biobank

2021 ◽  
pp. 1-9
Author(s):  
Chiara Fabbri ◽  
Julian Mutz ◽  
Cathryn M. Lewis ◽  
Alessandro Serretti
Keyword(s):  
Depressive Symptoms ◽  
Risk Scores ◽  
Depression Symptoms ◽  
Uk Biobank ◽  
Single Episode ◽  
History Of ◽  
Physical Diseases ◽  
Self Harm ◽  
The Uk

Abstract Background Wellbeing has a fundamental role in determining life expectancy and major depressive disorder (MDD) is one of the main modulating factors of wellbeing. This study evaluated the modulators of wellbeing in individuals with lifetime recurrent MDD (RMDD), single-episode MDD (SMDD) and no MDD in the UK Biobank. Methods Scores of happiness, meaningful life and satisfaction about functioning were condensed in a functioning-wellbeing score (FWS). We evaluated depression and anxiety characteristics, neuroticism-related traits, physical diseases, lifestyle and polygenic risk scores (PRSs) of psychiatric disorders. Other than individual predictors, we estimated the cumulative contribution to FWS of each group of predictors. We tested the indirect role of neuroticism on FWS through the modulation of depression manifestations using a mediation analysis. Results We identified 47 966, 21 117 and 207 423 individuals with lifetime RMDD, SMDD and no MDD, respectively. Depression symptoms and personality showed the largest impact on FWS (variance explained ~20%), particularly self-harm, worthlessness feelings during the worst depression, chronic depression, loneliness and neuroticism. Personality played a stronger role in SMDD. Anxiety characteristics showed a higher effect in SMDD and no MDD groups. Neuroticism played indirect effects through specific depressive symptoms that modulated FWS. Physical diseases and lifestyle explained only 4–5% of FWS variance. The PRS of MDD showed the largest effect on FWS compared to other PRSs. Conclusions This was the first study to comprehensively evaluate the predictors of wellbeing in relation to the history of MDD. The identified variables are important to identify individuals at risk and promote wellbeing.

scholarly journals Change in Negative Attention Bias Mediates the Association Between Attention Bias Modification Training and Depression Symptom Improvement

2021 ◽  
Author(s):  
Christopher G Beevers ◽  
Kean J. Hsu ◽  
David M Schnyer ◽  
Jasper A. J. Smits ◽  
Jason Shumake
Keyword(s):  
Eye Tracking ◽  
Attentional Bias ◽  
Attention Bias ◽  
Symptom Improvement ◽  
Depression Symptoms ◽  
Depression Symptom ◽  
Attention Bias Modification ◽  
Mediation Effects ◽  
Depression Change ◽  
Bias Modification

Attention bias modification training (ABMT) is purported to reduce depression by targeting and modifying an attentional bias for sadness-related stimuli. However, few tests of this hypothesis have been completed. Method: The current study examined whether change in attentional bias mediated a previously reported association between ABMT condition (active ABMT, sham ABMT, assessments only; N = 145) and depression symptom change among depressed adults. The pre-registered, primary measure of attention bias was a discretized eye tracking metric that quantified the proportion of trials where gaze time was greater for sad stimuli than neutral stimuli. Results: Contemporaneous longitudinal simplex mediation indicated that change in attentional bias early in treatment partially mediated the effect of ABMT on depression symptoms. Specificity analyses indicated that in contrast to the eye-tracking mediator, reaction time assessments of attentional bias for sad stimuli (mean bias and trial level variability) and lapses in sustained attention did not mediate the association between ABMT and depression change. Results also suggested that mediation effects were limited to a degree by suboptimal measurement of attentional bias for sad stimuli. Conclusion: When effective, ABMT may improve depression in part by reducing an attentional bias for sad stimuli, particularly early on during ABMT.

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