Medical crisis checklists in the emergency department: a simulation-based multi-institutional randomised controlled trial

2021 ◽  
pp. bmjqs-2020-012740
Author(s):  
Eric Dryver ◽  
Jakob Lundager Forberg ◽  
Caroline Hård af Segerstad ◽  
William D Dupont ◽  
Anders Bergenfelz ◽  
...  
Keyword(s):  
Similar Case ◽  
Controlled Trial ◽  
Haemorrhagic Shock ◽  
Primary Outcome Measure ◽  
Tricyclic Antidepressant ◽  
Median Percentage ◽  
Team Members ◽  
Senior Nurse ◽  
Emergency Interventions ◽  
Randomised Controlled

BackgroundStudies carried out in simulated environments suggest that checklists improve the management of surgical and intensive care crises. Whether checklists improve the management of medical crises simulated in actual emergency departments (EDs) is unknown.MethodsEight crises (anaphylactic shock, life-threatening asthma exacerbation, haemorrhagic shock from upper gastrointestinal bleeding, septic shock, calcium channel blocker poisoning, tricyclic antidepressant poisoning, status epilepticus, increased intracranial pressure) were simulated twice (once with and once without checklist access) in each of four EDs—of which two belong to an academic centre—and managed by resuscitation teams during their clinical shifts. A checklist for each crisis listing emergency interventions was derived from current authoritative sources. Checklists were displayed on a screen visible to all team members. Crisis and checklist access were allocated according to permuted block randomisation. No team member managed the same crisis more than once. The primary outcome measure was the percentage of indicated emergency interventions performed.ResultsA total of 138 participants composing 41 resuscitation teams performed 76 simulations (38 with and 38 without checklist access) including 631 interventions. Median percentage of interventions performed was 38.8% (95% CI 35% to 46%) without checklist access and 85.7% (95% CI 80% to 88%) with checklist access (p=7.5×10−8). The benefit of checklist access was similar in the four EDs and independent of senior physician and senior nurse experience, type of crisis and use of usual cognitive aids. On a Likert scale of 1–6, most participants agreed (gave a score of 5 or 6) with the statement ‘I would use the checklist if I got a similar case in reality’.ConclusionIn this multi-institution study, checklists markedly improved local resuscitation teams’ management of medical crises simulated in situ, and most personnel reported that they would use the checklists if they had a similar case in reality.

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

scholarly journals Effects of Deqi on Autonomic Balance in Adult Tinnitus Patients: Study Design of a Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Qian-Qian Li ◽  
Guang-Xia Shi ◽  
Xin-Xing Fu ◽  
Li-Li Han ◽  
Li-Ying Liu ◽  
...  
Keyword(s):  
Heart Rate ◽  
Heart Rate Variability ◽  
Nervous System ◽  
Autonomic Nervous System ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Autonomic Nervous ◽  
Nervous System Function ◽  
Acupuncture Effect ◽  
Randomised Controlled

Background. Recent reports suggest that a proportion of tinnitus patients suffer from mental illness. Autonomic nervous system plays a useful role in tinnitus therapy since electrical vagal nerve stimulation (VNS) has been frequently used to alleviate tinnitus-induced depression in clinic. heart rate variability (HRV), which is reflective of autonomic nervous system function, has been proved to be modulated by acupuncture. In the present study, we aim to compare the effect of deqi sensation on heart rate variability in adult tinnitus patients.Methods. Thirty participants are randomly assigned to verum acupuncture (creating deqi) or shallow acupuncture (not creating deqi) at Baihui (Du-20), Shenting (Du-24), Tinghui (GB-2), Waiguan (SJ-5), and Zulinqi (GB-41) for 3 weeks. The primary outcome measure is heart rate variability, which is measured at the first acupuncture, as well as the last acupuncture.Discussion. Completion of this trial will help to identify the role of deqi sensation in acupuncture effect for tinnitus and reveal an autonomic modulation mechanism for acupuncture effect.Trial Registration. This trial is registered with International Standard Randomised Controlled Trial NumberISRCTN58013563.

scholarly journals N-acetylcysteine for cessation of tobacco smoking: rationale and study protocol for a randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Lauren Arancini ◽  
Chiara C. Bortolasci ◽  
Seetal Dodd ◽  
Olivia M. Dean ◽  
Michael Berk
Keyword(s):  
Public Health ◽  
Tobacco Smoking ◽  
Rating Scales ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Trial Registration ◽  
Diagnostic Statistics ◽  
Salivary Cotinine ◽  
Randomised Controlled ◽  
Clinical Trials Registry

Abstract Background Tobacco smoking is a highly prevalent, addictive behaviour and a key public health priority. However available cessation therapies have low quit and high relapse rates, indicating an urgent need for more effective treatments. Predicated on promising preclinical and pilot clinical data, this paper presents a rationale and protocol for the trial of N-acetylcysteine (NAC) as a novel anti-craving smoking cessation aid. Methods Current smokers (n = 120) of at least 10 cigarettes a day are recruited through online advertisements, print publications and dissemination of flyers. Participants are randomised on a 1:1 ratio to receive either 16-week treatment of 1.8 g/day of NAC or placebo with all participants receiving quit support from the online QuitCoach tool. Participants are attending visits at baseline, 8 and 16 weeks with a 42-week post-discontinuation follow-up. The primary outcome measure is sustained abstinence at six months after treatment based on self-reported rating scales and confirmed by exhaled carbon monoxide and salivary cotinine levels. Secondary outcomes are timing of the first lapse and relapse, between-group cigarette consumption, withdrawal symptoms, general wellbeing and mood/anxiety symptoms. Between-group differences in adverse events and subgroup analyses for variables including gender and Diagnostic Statistics Manual 5 diagnostics will also be investigated. Discussion The planned trial addresses an issue of major importance to human health and, if an effect is shown, may result in substantial changes to the management of smoking and nicotine addiction with overt public health implications. Trial registration Australian New Zealand Clinical Trials registry (ANZCTR), ACTRN12617001478303. Registered on 19 October 2017.

scholarly journals A Randomised Controlled Trial Comparing Intravaginal Misoprostol and Intracervical Dinoprostone in Pre Induction Cervical Ripening

2013 ◽  
Vol 1 (03) ◽  
pp. 45-54
Author(s):  
B. H. Radhika ◽  
S. Soundara Raghavan
Keyword(s):  
Controlled Trial ◽  
Mode Of Delivery ◽  
Primary Outcome Measure ◽  
Cervical Ripening ◽  
Secondary Outcome ◽  
Bishop Score ◽  
Intervention Delivery ◽  
Misoprostol Group ◽  
Randomised Controlled ◽  
Mean Cost

Objective: To compare the efficacy and safety of intravaginal misoprostol with intracervical dinoprostone for preinduction cervical ripening. Material andMethods: It was a randomized controlled trial conducted at department of obstetrics and gynecology, JIPMER, Puducherry. Three hundred women with Bishop score of 6, were assigned randomly to receive either intravaginal misoprostol 25 μg every four hours for four doses, and intracervical dinoprostone gel 0.5 mg every eight hours for two doses. (one hundred women in each group). Oxytocin was initiated as per standardized protocol, if the cervix was favourable. If the cervical ripening was unsuccessful (Bishop score 6) after the maximum doses of drugs in both the groups, then further treatment was individualized. Efficacy and cost of the drugs were compared in both groups. Results: Primary outcome measure was change in Bishop score. Mean Bishop score change at the end of 16 hours was significantly higher in the misoprostol group, (2.57±0.59) compared to dinoprostone group (2.17±0.10, p=0.016). This finding was inspite of the fact that the dinoprostone group had higher Bishop score prior to the ripening.(3.55±0.56 vs 3.28±0.77, p=0.006). Secondary outcome measures such as mean intervention-delivery interval, oxytocin requirement, mode of delivery, maternal and neonatal outcomes were similar in both the groups. Overall mean cost of ripening agent per patient was significantly less in the misoprostol group, (22.56±93.16 rupees) compared to dinoprostone group (493.89±173.99 rupees, p0.0001).Conclusion: Low dose misoprostol is as effective as dinoprostone in cervical ripening and demonstrates similar fetal and maternal safety profile.

scholarly journals Efficacy of high-volume injections with and without corticosteroid compared with sham for Achilles tendinopathy: a protocol for a randomised controlled trial

2021 ◽  
Vol 7 (4) ◽  
pp. e001136
Author(s):  
Peter Malliaras ◽  
David Connell ◽  
Anders Ploug Boesen ◽  
Rebecca S Kearney ◽  
Hylton B Menz ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
High Volume ◽  
Primary Outcome Measure ◽  
Achilles Tendinopathy ◽  
Double Blind ◽  
Sham Injection ◽  
Intention To Treat ◽  
Randomised Controlled

IntroductionAchilles tendinopathy (AT) is a common and disabling musculoskeletal condition. First-line management involving Achilles tendon loading exercise with, or without, other modalities may not resolve the problem in up to 44% of cases. Many people receive injections. Yet there are no injection treatments with demonstrated long-term efficacy. The aim of the trial is to examine the 12-month efficacy of high-volume injection (HVI) with corticosteroid and HVI without corticosteroid versus sham injection among individuals with AT.Methods and analysisThe trial is a three-arm, parallel group, double-blind, superiority randomised controlled trial that will assess the efficacy of HVI with and without corticosteroid versus sham up to 12 months. We will block-randomise 192 participants to one of the three groups with a 1:1:1 ratio, and both participants and outcome assessors will be blinded to treatment allocation. All participants will receive an identical evidence-based education and exercise intervention. The primary outcome measure will be the Victorian Institute of Sport Assessment – Achilles (VISA-A) at 12 months post-randomisation, a validated, reliable and disease-specific measure of pain and function. Choice of secondary outcomes was informed by core outcome domains for tendinopathy. Data will be analysed using the intention-to-treat principle.Ethics and disseminationEthics approval was obtained via the Monash University Human Ethics Committee (no: 13138). The study is expected to be completed in 2024 and disseminated via peer review publication and conference presentations.Trial registration numberAustralia and New Zealand Clinical trials registry (ACTRN12619001455156)

scholarly journals Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette’s disorder: a pilot randomised controlled trial with long-term follow-up

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024685 ◽  
Author(s):  
Per Andrén ◽  
Kristina Aspvall ◽  
Lorena Fernández de la Cruz ◽  
Paulina Wiktor ◽  
Sofia Romano ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Behaviour Therapy ◽  
Tic Severity ◽  
Randomised Controlled

ObjectiveBehaviour therapy (BT) for Tourette’s disorder (TD) and persistent (chronic) motor or vocal tic disorder (PTD) is rarely available. We evaluated the feasibility of adapting two existing BT protocols for TD/PTD (habit reversal training (HRT) and exposure and response prevention (ERP)) into a therapist-guided and parent-guided online self-help format.DesignA pilot, single-blind, parallel group randomised controlled trial.SettingA specialist outpatient clinic in Sweden.ParticipantsTwenty-three young people with TD/PTD, aged 8–16.InterventionsTwo 10-week therapist-guided and parent-guided internet-delivered programmes (called BIP TIC HRT and BIP TIC ERP).OutcomeThe primary outcome measure was the Yale Global Tic Severity Scale. Blinded evaluators rated symptoms at baseline, post-treatment and 3-month follow-up (primary endpoint). All participants were naturalistically followed up to 12 months after treatment.ResultsPatients and parents rated the interventions as highly acceptable, credible and satisfactory. While both interventions resulted in reduced tic-related impairment, parent-rated tic severity and improved quality of life, only BIP TIC ERP resulted in a significant improvement on the primary outcome measure. Within-group effect sizes and responder rates were, respectively: d=1.12 and 75% for BIP TIC ERP, and d=0.50 and 55% for BIP TIC HRT. The therapeutic gains were maintained up to 12 months after the end of the treatment. Adverse events were rare in both groups. The average therapist support time was around 25 min per participant per week.ConclusionsInternet-delivered BT has the potential to greatly increase access to evidence-based treatment for young people with TD/PTD. Further evaluation of the efficacy and cost-effectiveness of this treatment modality is warranted.Trial registration numberNCT02864589; Pre-results.

scholarly journals The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015111 ◽  
Author(s):  
Mohamed Abdel-Fattah ◽  
Graeme MacLennan ◽  
Mary Kilonzo ◽  
R Phil Assassa ◽  
Kirsty McCormick ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Single Incision ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Female Stress Urinary Incontinence ◽  
Midurethral Slings ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.

scholarly journals Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

2018 ◽  
Vol 213 (1) ◽  
pp. 404-411 ◽  
Author(s):  
Ulrika Karlsson Stigsdotter ◽  
Sus Sola Corazon ◽  
Ulrik Sidenius ◽  
Patrik Karlsson Nyed ◽  
Helmer Bøving Larsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Significant Difference ◽  
Increasing Demand ◽  
Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

scholarly journals Recruiting people facing social disadvantage: the experience of the Free Meds study

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Pauline Norris ◽  
Kimberly Cousins ◽  
Marianna Churchward ◽  
Shirley Keown ◽  
Mariana Hudson ◽  
...  
Keyword(s):  
Social Deprivation ◽  
Controlled Trial ◽  
Social Disadvantage ◽  
Health Providers ◽  
Access To Health Services ◽  
Team Members ◽  
Recruitment Methods ◽  
Advantages And Disadvantages ◽  
Randomised Controlled ◽  
Maori Health

Abstract Background Researching access to health services, and ways to improve equity, frequently requires researchers to recruit people facing social disadvantage. Recruitment can be challenging, and there is limited high quality evidence to guide researchers. This paper describes experiences of recruiting 1068 participants facing social disadvantage for a randomised controlled trial of prescription charges, and provides evidence on the advantages and disadvantages of recruitment methods. Methods Those living in areas of higher social deprivation, taking medicines for diabetes, taking anti-psychotic medicines, or with COPD were eligible to participate in the study. Several strategies were trialled to meet recruitment targets. We initially attempted to recruit participants in person, and then switched to a phone-based system, eventually utilising a market research company to deal with incoming calls. We used a range of strategies to publicise the study, including pamphlets in pharmacies and medical centres, media (especially local newspapers) and social media. Results Enrolling people on the phone was cheaper on average than recruiting in person, but as we refined our approach over time, the cost of the latter dropped significantly. In person recruitment had many advantages, such as enhancing our understanding of potential participants’ concerns. Forty-nine percent of our participants are Māori, which we attribute to having Māori researchers on the team, recruiting in areas of high Māori population, team members’ existing links with Māori health providers, and engaging and working with Māori providers. Conclusions Recruiting people facing social disadvantage requires careful planning and flexible recruitment strategies. Support from organisations trusted by potential participants is essential. Registration The Free Meds study is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12618001486213).

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