Cadaveric simulation vs standard training for postgraduate trauma & orthopaedic surgical trainees: protocol for the CAD:TRAUMA study multi-centre randomised controlled educational trial (Preprint)

2020 ◽  
Author(s):  
Hannah James ◽  
Giles T R Pattison ◽  
Joanne D Fisher ◽  
Damian R Griffin
Keyword(s):  
Surgical Training ◽  
Simulation Training ◽  
Secondary Outcome ◽  
Power Calculation ◽  
Health State ◽  
Orthopaedic Surgeons ◽  
Cadaveric Simulation ◽  
Standard Training ◽  
Randomised Controlled ◽  
The Impact

BACKGROUND The quantity and quality of surgical training in the UK has been negatively affected by reduced working hours and NHS financial pressures. Traditionally surgical training has occurred by the master-apprentice model involving a process of graduated responsibility, but a modern alternative is to use simulation for the early stages of training. It is not known if simulation training for junior trainees can safeguard patients and improve clinical outcomes. This paper details the protocol for a multicentre randomised controlled educational trial of a cadaveric simulation training intervention versus standard training for junior postgraduate orthopaedic surgeons-in-training. OBJECTIVE To assess the impact of cadaveric simulation training on patient outcomes following three common orthopaedic operations METHODS We will recruit postgraduate orthopaedic surgeons-in-training in the first three years (of eight) of the specialist training programme. Participants will be block randomised and allocated to either cadaveric simulation or standard ‘on-the-job’ training, learning three common orthopaedic procedures, each of which is a sub-study within the trial. The procedures are 1) Dynamic Hip Screw(DHS), 2) hemiarthroplasty and 3) ankle fracture fixation. These procedures have been selected as they are very common procedures which are routinely performed by junior surgeons-in-training. A pragmatic approach to sample size is taken in lieu of a formal power calculation as this is novel exploratory work with no a priori estimate of effect size to reference. The primary outcome measure is the technical success of the surgery performed on patients by the participating surgeons-in-training during the follow-up period for the three sub-study procedures, as measured by the implant position on the post-operative radiograph. The secondary outcome measures are procedure time, post-operative complication rate and patient health state at 4 months post-operation (EQ-5D – substudies 1 and 2 only). RESULTS Not applicable - this is a trial protocol. CONCLUSIONS The results of this trial will be submitted to a peer-reviewed journal and will inform educational and clinical practice. CLINICALTRIAL ISRCTN20431944; Pre-results

scholarly journals Cadaveric simulation versus standard training for postgraduate trauma and orthopaedic surgical trainees: protocol for the CAD:TRAUMA study multicentre randomised controlled educational trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e037319
Author(s):  
Hannah K James ◽  
Giles T R Pattison ◽  
Joanne D Fisher ◽  
Damian Griffin
Keyword(s):  
Research Ethics ◽  
Outcome Measures ◽  
Surgical Training ◽  
Simulation Training ◽  
Secondary Outcome ◽  
Orthopaedic Surgeons ◽  
Cadaveric Simulation ◽  
Patient Consent ◽  
Standard Training ◽  
Randomised Controlled

IntroductionThe quantity and quality of surgical training in the UK has been negatively affected by reduced working hours and National Health Service (NHS) financial pressures. Traditionally surgical training has occurred by the master-apprentice model involving a process of graduated responsibility, but a modern alternative is to use simulation for the early stages of training. It is not known if simulation training for junior trainees can safeguard patients and improve clinical outcomes. This paper details the protocol for a multicentre randomised controlled educational trial of a cadaveric simulation training intervention versus standard training for junior postgraduate orthopaedic surgeons-in-training. This is the first study to assess the effect of cadaveric simulation training for open surgery on patient outcome. The feasibility of delivering cadaveric training, use of radiographic and clinical outcome measures to assess impact and the challenges of upscaling provision will be explored.Methods and analysisWe will recruit postgraduate orthopaedic surgeons-in-training in the first 3 years (of 8) of the specialist training programme. Participants will be block randomised and allocated to either cadaveric simulation or standard ‘on-the-job’ training, learning three common orthopaedic procedures, each of which is a substudy within the trial. The procedures are (1) dynamic hip screw, (2) hemiarthroplasty and (3) ankle fracture fixation. These procedures have been selected as they are very common procedures which are routinely performed by junior surgeons-in-training. A pragmatic approach to sample size is taken in lieu of a formal power calculation as this is novel exploratory work with no a priori estimate of effect size to reference. The primary outcome measure is the technical success of the surgery performed on patients by the participating surgeons-in-training during the follow-up period for the three substudy procedures, as measured by the implant position on the postoperative radiograph. The secondary outcome measures are procedure time, postoperative complication rate and patient health state at 4 months postoperation (EQ-5D—substudies 1 and 2 only).Ethics, registration and disseminationNational research ethics approval was granted for this study by the NHS Research Authority South Birmingham Research Ethics Committee (15/WM/0464). Confidentiality Advisory Group approval was granted for accessing radiographic and outcome data without patient consent on 27 February 2017 (16/CAG/0125). The results of this trial will be submitted to a peer-reviewed journal and will inform educational and clinical practice.Trial registration numberISRCTN20431944

scholarly journals Impact of screening for risk of suicide: randomised controlled trial

2011 ◽  
Vol 198 (5) ◽  
pp. 379-384 ◽  
Author(s):  
Mike J. Crawford ◽  
Lavanya Thana ◽  
Caroline Methuen ◽  
Pradip Ghosh ◽  
Sian V. Stanley ◽  
...  
Keyword(s):  
Primary Care ◽  
Suicidal Ideation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Worth Living ◽  
Early Screening ◽  
Care Services ◽  
Randomised Controlled ◽  
The Impact

BackgroundConcerns have been expressed about the impact that screening for risk of suicide may have on a person's mental health.AimsTo examine whether screening for suicidal ideation among people who attend primary care services and have signs of depression increases the short-term incidence of feeling that life is not worth living.MethodIn a multicentre, single-blind, randomised controlled trial, 443 patients in four general practices were randomised to screening for suicidal ideation or control questions on health and lifestyle (trial registration: ISRCTN84692657). The primary outcome was thinking that life is not worth living measured 10–14 days after randomisation. Secondary outcome measures comprised other aspects of suicidal ideation and behaviour.ResultsA total of 443 participants were randomised to early (n = 230) or delayed screening (n = 213). Their mean age was 48.5 years (s.d. = 18.4, range 16–92) and 137 (30.9%) were male. The adjusted odds of experiencing thoughts that life was not worth living at follow-up among those randomised to early compared with delayed screening was 0.88 (95% CI 0.66–1.18). Differences in secondary outcomes between the two groups were not seen. Among those randomised to early screening, 37 people (22.3%) reported thinking about taking their life at baseline and 24 (14.6%) that they had this thought 2 weeks later.ConclusionsScreening for suicidal ideation in primary care among people who have signs of depression does not appear to induce feelings that life is not worth living.

scholarly journals Advance notice of contraceptive availability at surgical abortion: a pilot randomised controlled trial

2018 ◽  
Vol 44 (3) ◽  
pp. 187-192 ◽  
Author(s):  
Andrea H Roe ◽  
Jennifer Fortin ◽  
Danielle Gelfand ◽  
Elizabeth Janiak ◽  
Rie Maurer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Contraceptive Method ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Pilot Randomised Controlled Trial ◽  
Contraceptive Knowledge ◽  
Advance Notice ◽  
Randomised Controlled ◽  
Surgical Abortion ◽  
The Impact

BackgroundWith advance notice about the availability and effectiveness of contraceptive methods, abortion patients have more time and information for decision-making. We assessed the impact of an informational telephone call prior to the surgical abortion visit on patient contraceptive knowledge.MethodsThis was a pilot randomised controlled trial. Prior to their abortion visit, participants were randomised to the intervention message, a standardised notification about the availability, effectiveness and safety of long-acting (LARC) and short-acting reversible contraception (SARC) on the day of the abortion, or to the control message, a reiteration of appointment logistics without information about contraception. At the visit, participants completed a pre-procedure survey to assess contraceptive knowledge and usefulness of the intervention. The primary outcome was knowledge of LARC availability immediately after surgical abortion. A secondary outcome was contraceptive method uptake.ResultsWe enrolled 234 subjects. The pre-visit telephone notification improved knowledge that LARC is available immediately after surgical abortion (71.3% vs 50.9%, P<0.01). Participants in both study arms found the telephone notifications useful. Post-abortion contraceptive method choice did not differ between study arms.ConclusionsAdvance notice about contraception was acceptable to surgical abortion patients and improved their contraceptive knowledge.Trial registration numberNCT02836561.

scholarly journals Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e040550
Author(s):  
Jean-Francois Payen ◽  
Marion Richard ◽  
Gilles Francony ◽  
Gérard Audibert ◽  
Emmanuel L Barbier ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Severe Traumatic Brain Injury ◽  
Life Assessment ◽  
Secondary Outcome ◽  
Trauma Patients ◽  
Brain Tissue Oxygenation ◽  
Severe Tbi ◽  
Randomised Controlled ◽  
The Impact

IntroductionIntracranial hypertension is considered as an independent risk factor of mortality and neurological disabilities after severe traumatic brain injury (TBI). However, clinical studies have demonstrated that episodes of brain ischaemia/hypoxia are common despite normalisation of intracranial pressure (ICP). This study assesses the impact on neurological outcome of guiding therapeutic strategies based on the monitoring of both brain tissue oxygenation pressure (PbtO2) and ICP during the first 5 days following severe TBI.Methods and analysisMulticentre, open-labelled, randomised controlled superiority trial with two parallel groups in 300 patients with severe TBI. Intracerebral monitoring must be in place within the first 16 hours post-trauma. Patients are randomly assigned to the ICP group or to the ICP + PbtO2 group. The ICP group is managed according to the international guidelines to maintain ICP≤20 mm Hg. The ICP + PbtO2 group is managed to maintain PbtO2 ≥20 mm Hg in addition to the conventional optimisation of ICP. The primary outcome measure is the neurological status at 6 months as assessed using the extended Glasgow Outcome Scale. Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days. Analysis will be performed according to the intention-to-treat principle and full statistical analysis plan developed prior to database freeze.Ethics and disseminationThis study has been approved by the Institutional Review Board of Sud-Est V (14-CHUG-48) and from the National Agency for Medicines and Health Products Safety (Agence Nationale de Sécurité du Médicament et des produits de santé) (141 435B-31). Results will be presented at scientific meetings and published in peer-reviewed publications.The study was registered with ClinTrials NCT02754063 on 28 April 2016 (pre-results).

scholarly journals Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036799 ◽  
Author(s):  
David Blanco ◽  
Sara Schroter ◽  
Adrian Aldcroft ◽  
David Moher ◽  
Isabelle Boutron ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Review ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomised Trials ◽  
Randomised Controlled ◽  
The Impact ◽  
Completeness Of Reporting

ObjectiveTo evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.DesignRandomised controlled trial (RCT).SettingBMJ Open’s quality improvement programme.Participants24 manuscripts describing RCTs.InterventionsWe used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.OutcomesThe primary outcome is the number of adequately reported items (0–8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.ResultsManuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.ConclusionsWe demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.Trial registration numberNCT03751878.

scholarly journals The HELPER programme: HEalthy Living and Prevention of Early Relapse – three exploratory randomised controlled trials of phase-specific interventions in first-episode psychosis

2015 ◽  
Vol 3 (2) ◽  
pp. 1-238 ◽  
Author(s):  
Max Marshall ◽  
Christine Barrowclough ◽  
Richard Drake ◽  
Nusrat Husain ◽  
Fiona Lobban ◽  
...  
Keyword(s):  
Early Intervention ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Psychotic Symptoms ◽  
First Episode ◽  
Controlled Trials ◽  
Early Intervention Services ◽  
Sufficient Power ◽  
Randomised Controlled ◽  
The Impact

BackgroundSchizophrenia represents a substantial cost to the NHS and society because it is common (lifetime prevalence around 0.5–1%); it begins in adolescence or early adulthood and often causes lifelong impairment. The first 3 years are a ‘critical period’ in which the course of the illness is determined. Hence under the NHS Plan, specialist early intervention in psychosis services were established to care for people who develop psychosis between the ages of 14 and 35 years for the first 3 years of their illness. However, there has been a lack of evidence-based treatments specifically designed for the early years. This is important because emerging evidence has shown that in the critical period it is vital to avoid relapse and prevent deterioration in physical health, as both can drastically reduce the chances of a full recovery.ObjectivesTo develop and evaluate three phase-specific interventions to prevent relapse and/or deterioration in physical health in people with first-episode psychosis. The interventions were (1) cognitive remediation (CR) to improve meta-cognition and insight and enhance engagement in cognitive therapy [evaluated in the IMproving PArticipation in Cognitive Therapy (IMPACT) trial]; (2) a healthy-living intervention to control weight in people taking antipsychotic medication after a first episode of psychosis [evaluated in the INTERvention to Encourage ACTivity, Improve Diet, and Reduce Weight Gain (InterACT trial)]; and (3) integrated motivational interviewing and cognitive–behavioural therapy (MiCBT) to reduce cannabis use [evaluated in the Rethinking Choices After Psychosis (ReCAP) trial]. The trials were conducted to explore the case for larger definitive trials with relapse as a primary outcome measure. However, as small trials do not have sufficient power to detect significant reductions in relapse, each was focused on a relevant primary outcome for which there was sufficient power to detect a significant difference. In all three trials relapse was a secondary outcome in the hope of detecting trends towards lower relapse rates in the presence of effective interventions or a general trend across all three studies towards lower relapse rates.DesignThree exploratory randomised controlled trials (RCTs) accompanied by qualitative work employing grounded theory and framework analysis to inform the interventions and determine acceptability (InterACT and ReCAP trials).SettingFive early-intervention services in the north-west of England.ParticipantsEarly-intervention service users aged 16–35 years who had recently experienced a first episode of psychosis. Participants in the IMPACT trial were drawn from a waiting list of people referred for routine CBT; those in the InterACT trial were required to have a body mass index (BMI) of ≥ 25 kg/m2(or ≥ 24 kg/m2for service users from the South Asian community); and those in the ReCAP trial metDiagnostic and Statistical Manual of Mental Disorders– Fourth Edition (DSM-IV) criteria for cannabis abuse or dependence.InterventionsThe IMPACT trial involved 13 sessions of CR over 12 weeks; the InterACT trial involved eight face-to-face sessions plus optional group activities over 12 months; and the ReCAP trial involved MiCBT in brief (12 sessions over 4.5 months) and long (24 sessions over 9 months) forms.Main outcome measuresThe primary outcome in the IMPACT trial was psychotic symptoms assessed by the Psychotic Symptom Rating Scales (PSYRATS). BMI was the primary outcome in the InterACT trial and cannabis use (measured by timeline follow-back) was the primary outcome in the ReCAP trial. Relapse was a secondary outcome across all three trials.ResultsIn the IMPACT trial there was no beneficial effect of CR on psychotic symptoms; however, the amount of CBT required was significantly less after CR. In the InterACT trial a small reduction in BMI in the intervention group was not statistically significant. For participants taking olanzapine or clozapine the effect size was larger although not significant. Outcome data from the ReCAP trial are not yet available. Retention in all three trials was good, indicating that the interventions were acceptable.ConclusionsEarly-intervention services provided a good setting to conduct trials. The IMPACT trial found that CR delivered by relatively unskilled workers improved the efficiency of subsequent CBT. Across the three trials there was little evidence that any intervention reduced relapse.Trial registrationCurrent Controlled Trials ISRCTN17160673 (IMPACT); Current Controlled Trials ISRCTN22581937 (InterACT); Current Controlled Trials ISRCTN88275061 (ReCAP).FundingThis project was funded by the NIHR Programme Grants for Applied Research programme and will be published in full inProgramme Grants for Applied Research; Vol. 3, No. 2. See the NIHR Journals Library website for further project information.

scholarly journals Training approaches for the deployment of a mechanical chest compression device: a randomised controlled manikin study

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e019009 ◽  
Author(s):  
Keith Couper ◽  
Rochelle M Velho ◽  
Tom Quinn ◽  
Anne Devrell ◽  
Ranjit Lall ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Chest Compression ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Compression Device ◽  
Compression Flow ◽  
Mechanical Chest Compression ◽  
Resuscitation Training ◽  
Standard Training ◽  
Randomised Controlled

ObjectivesTo evaluate the effect of training strategy on team deployment of a mechanical chest compression device.DesignRandomised controlled manikin trial.SettingLarge teaching hospital in the UK.ParticipantsTwenty teams, each comprising three clinicians. Participating individuals were health professionals with intermediate or advanced resuscitation training.InterventionsTeams were randomised in a 1:1 ratio to receive either standard mechanical chest compression device training or pit-crew device training. Training interventions lasted up to 1 h. Performance was measured immediately after training in a standardised simulated cardiac arrest scenario in which teams were required to deploy a mechanical chest compression device.Primary and secondary outcome measuresPrimary outcome was chest compression flow fraction in the minute preceding the first mechanical chest compression. Secondary outcomes included cardiopulmonary resuscitation quality and mechanical device deployment metrics, and non-technical skill performance. Outcomes were assessed using video recordings of the test scenario.ResultsIn relation to the primary outcome of chest compression flow fraction in the minute preceding the first mechanical chest compression, we found that pit-crew training was not superior to standard training (0.76 (95% CI 0.73 to 0.79) vs 0.77 (95% CI 0.73 to 0.82), mean difference −0.01 (95% CI −0.06 to 0.03), P=0.572). There was also no difference between groups in performance in relation to any secondary outcome.ConclusionsPit-crew training, compared with standard training, did not improve team deployment of a mechanical chest device in a simulated cardiac arrest scenario.Trial registration numberISRCTN43049287; Pre-results.

scholarly journals Soiled airway tracheal intubation and the effectiveness of decontamination by United Kingdom paramedics (SATIATED2): A randomised controlled manikin study

2020 ◽  
Vol 17 ◽  
Author(s):  
Graham McClelland ◽  
Richard Pilbery ◽  
Sarah Hepburn
Keyword(s):  
United Kingdom ◽  
Success Rate ◽  
Primary Outcome ◽  
Ambulance Service ◽  
Secondary Outcome ◽  
North East ◽  
Intubation Success ◽  
Intubation Success Rate ◽  
Randomised Controlled ◽  
The Impact

Introduction Vomiting and regurgitation are commonly encountered in out-of-hospital cardiac arrest, but traditional paramedic suctioning techniques may be insufficient to manage severely soiled airways. The Suction Assisted Laryngoscopy and Airway Decontamination (SALAD) technique was developed to help clinicians manage soiled airways. SATIATED2 reports the impact of SALAD training in North East Ambulance Service (NEAS) in the United Kingdom following the original SATIATED study in the Yorkshire Ambulance Service. The primary research question was: Among NEAS paramedics, does the addition of SALAD training, compared to standard training, improve the success rate of intubation for the soiled airway? Methods A randomised controlled trial of SALAD was conducted using a modified airway manikin capable of vomiting. The intervention comprised SALAD training and the introduction of the DuCanto catheter. Paramedic volunteers were block randomised into two groups: A01A02B01 who made two pre-training intubation attempts and one post-training attempt, and A11B11B12, who made one pre-training and two post-training attempts. The primary outcome was intubation success rate at the second attempt. The time taken to intubate was recorded as a secondary outcome. SATIATED2 was registered with ISRCTN (ISRCTN17329526) and funded internally with commercial support from SSCOR who supplied the DuCanto catheters. Results One-hundred and two paramedics (51 AAB, 51 ABB) were recruited between August and December 2019 with 99 participating (50 AAB, 49 ABB). The primary outcome was intubation success rate on the second attempt (A02 vs. B11) which were 86% without SALAD and 96% with SALAD; a non-significant improvement of 10% (95% CI: 1–21, p=0.09). The total intubation success rate pre-training (A01+A02+A11) was 75% (112/149) compared with 98% (145/148) post-training (B01+B11+B12). Conclusion NEAS paramedics demonstrated improved, but non-significant, intubation success rates in a simulated soiled airway following SALAD training.

The Need to Belong and the Relationship Between Loneliness and Health

2014 ◽  
Vol 22 (4) ◽  
pp. 194-201 ◽  
Author(s):  
Freda-Marie Hartung ◽  
Britta Renner
Keyword(s):  
Individual Differences ◽  
Social Isolation ◽  
Social Situation ◽  
First Year ◽  
Health State ◽  
Need To Belong ◽  
First Year University ◽  
Perceived Social Isolation ◽  
The Impact ◽  
The Relationship

Humans are social animals; consequently, a lack of social ties affects individuals’ health negatively. However, the desire to belong differs between individuals, raising the question of whether individual differences in the need to belong moderate the impact of perceived social isolation on health. In the present study, 77 first-year university students rated their loneliness and health every 6 weeks for 18 weeks. Individual differences in the need to belong were found to moderate the relationship between loneliness and current health state. Specifically, lonely students with a high need to belong reported more days of illness than those with a low need to belong. In contrast, the strength of the need to belong had no effect on students who did not feel lonely. Thus, people who have a strong need to belong appear to suffer from loneliness and become ill more often, whereas people with a weak need to belong appear to stand loneliness better and are comparatively healthy. The study implies that social isolation does not impact all individuals identically; instead, the fit between the social situation and an individual’s need appears to be crucial for an individual’s functioning.

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