scholarly journals SP2.1.9Augmented terminal feedback influences cognitive ability of surgical trainees: a randomised controlled trial

2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Mohammad Riaz ◽  
Rachel Phing HO ◽  
Benjie Tang ◽  
Afshin Alijani
Keyword(s):  
Error Detection ◽  
Controlled Trial ◽  
Assessment Method ◽  
Formative Assessments ◽  
Current Standard ◽  
Cognitive Approach ◽  
Rater Reliability ◽  
Video Recordings ◽  
Surgical Trainees ◽  
Randomised Controlled

Abstract Introduction Formative assessments in the form of Global assessment (GAS) and procedural based assessment (PBA) are the current methods used for feedback in British laparoscopic surgical training. Video error signature feedback (VESF) has been proposed as an alternative approach to enhance motor skills in laparoscopic training through influencing cognitive approach. Methods Twenty laparoscopic novice students were randomised into Current standard feedback (CSF) and VESF groups. Both groups tied laparoscopic double square knots in four sequential stages. Standard human reliability assessment method (HRA) was utilised to assess unedited video recordings for errors. A validated scoring system by expert trainers assessed proficiency gain. Similar assessment was performed for both groups. Unedited video recordings of the VESF group were annotated for errors at each stage and provided as feedback through video hosting website. CSF group received assessment sheet as their feedback, comparable to current practice. Error numbers, time execution and proficiency gain were the outcomes. Inter-rater reliability among trainers for error detection was established. Results A total of 6490 movements were studied with 1613 errors detected. VESF group committed significantly less errors as compared to the CSF group [1011/1613 (63%) vs 602/1613 (37%), p < 0.01]. VESF group gained proficiency earlier. Time execution was similar. Inter-rater reliability for error detection was high (p = 0.96). Discussion VESF effects cognitive framework of a laparoscopic task in trainee’s mind, ultimately reducing errors. This work demonstrated the practical application of video error signature feedback by demonstrating a simple laparoscopic task and analysing its learning process through novice brains.

Preventing Delirium and Promoting Long-Term Brain Health: A Clinical Trial Design for the Perioperative Cognitive Enhancement (PROTECT) Trial

2021 ◽  
Vol 83 (4) ◽  
pp. 1637-1649
Author(s):  
Kelly J. Atkins ◽  
David A. Scott ◽  
Brendan Silbert ◽  
Kerryn E. Pike ◽  
Lis Evered
Keyword(s):  
Older Adults ◽  
Controlled Trial ◽  
Neuropsychological Test ◽  
Functional Decline ◽  
Clinical Trial Design ◽  
Early Mobilization ◽  
Assessment Method ◽  
Neurocognitive Disorder ◽  
Current Standard ◽  
Secondary Outcomes

Background: Perioperative neurocognitive disorders (PND), including postoperative delirium (POD), are common in older adults and, for many, precipitate functional decline and/or dementia. Objective: In this protocol, we describe a novel multidisciplinary, multicomponent perioperative intervention that seeks to prevent or reduce POD and associated cognitive decline. Methods: We will conduct a prospective, single-blind, pragmatic, randomized-controlled trial to compare our tailored multi-disciplinary perioperative pathway against current standard of care practices. We will recruit a total of 692 elective surgical patients aged 65 years or more and randomize them in a 1:1 design. Our perioperative intervention targets delirium risk reduction strategies by emphasizing the importance of early mobilization, nutrition, hydration, cognitive orientation, sensory aids, and avoiding polypharmacy. To promote healthy behavior change, we will provide a tailored psychoeducation program both pre- and postoperatively, focusing on cardiovascular and psychosocial risks for cognitive and functional decline. Results: Our primary outcome is the incidence of any PND (encapsulating POD and mild or major postoperative neurocognitive disorder) at three months postoperative. Secondary outcomes include any incidence of POD or neurocognitive disorder at 12 months. A specialized delirium screening instrument, the Confusion Assessment Method (3D-CAM), and a neuropsychological test battery, will inform our primary and secondary outcomes. Conclusion: Delirium is a common and debilitating postoperative complication that contributes to the cognitive and functional decline of older adults. By adopting a multicomponent, multidisciplinary approach to perioperative delirium prevention, we seek to reduce the burden of delirium and subsequent dementia in older adults.

scholarly journals High dose oral and intravenous rifampicin for improved survival from adult tuberculous meningitis: a phase II open-label randomised controlled trial (the RifT study)

2018 ◽  
Vol 3 ◽  
pp. 83 ◽  
Author(s):  
Fiona V. Cresswell ◽  
Kenneth Ssebambulidde ◽  
Daniel Grint ◽  
Lindsey te Brake ◽  
Abdul Musabire ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Hiv Positive ◽  
Current Standard ◽  
Open Label ◽  
Dose Oral ◽  
Randomised Controlled ◽  
Positive Population

Background: Tuberculous meningitis (TBM) has 44% (95%CI 35-52%) in-hospital mortality with standard therapy in Uganda. Rifampicin, the cornerstone of TB therapy, has 70% oral bioavailability and ~10-20% cerebrospinal fluid (CSF) penetration.  With current WHO-recommended TB treatment containing 8-12mg/kg rifampicin, CSF rifampicin exposures frequently fall below the minimal inhibitory concentration for M. tuberculosis. Two Indonesian phase II studies, the first investigating intravenous rifampicin 600mg and the second oral rifampicin ~30mg/kg, found the interventions were safe and resulted in significantly increased CSF rifampicin exposures and a reduction in 6-month mortality in the investigational arms. Whether such improvements can be replicated in an HIV-positive population remains to be determined. Protocol: We will perform a phase II, open-label randomised controlled trial, comparing higher-dose oral and intravenous rifampicin with current standard of care in a predominantly HIV-positive population. Participants will be allocated to one of three parallel arms (I:I:I): (i) intravenous rifampicin 20mg/kg for 2-weeks followed by oral rifampicin 35mg/kg for 6-weeks; (ii) oral rifampicin 35mg/kg for 8-weeks; (iii) standard of care, oral rifampicin 10mg/kg/day for 8-weeks. Primary endpoints will be: (i) pharmacokinetic parameters in plasma and CSF; (ii) safety. We will also examine the effect of higher-dose rifampicin on survival time, neurological outcomes and incidence of immune reconstitution inflammatory syndrome. We will enrol 60 adults with suspected TBM, from two hospitals in Uganda, with follow-up to 6 months post-enrolment. Discussion: HIV co-infection affects the bioavailability of rifampicin in the initial days of therapy, risk of drug toxicity and drug interactions, and ultimately mortality from TBM. Our study aims to demonstrate, in a predominantly HIV-positive population, the safety and pharmacokinetic superiority of one or both investigational arms compared to current standard of care. The most favourable dose may ultimately be taken forward into an adequately powered phase III trial. Trial registration: ISRCTN42218549 (24th April 2018)

scholarly journals Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lenka A. Vodstrcil ◽  
◽  
Erica L. Plummer ◽  
Michelle Doyle ◽  
Christopher K. Fairley ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bacterial Vaginosis ◽  
Controlled Trial ◽  
Male Partner ◽  
Standard Of Care ◽  
Trial Registration ◽  
Current Standard ◽  
Randomised Controlled ◽  
Oral Metronidazole ◽  
Amsel Criteria

Abstract Background Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care. Methods StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4–10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4–10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks. Discussion Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence. Trial registration The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111–1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true).

scholarly journals Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jeremy Horwood ◽  
Melanie Chalder ◽  
Ben Ainsworth ◽  
James Denison-Day ◽  
Frank de Vocht ◽  
...  
Keyword(s):  
Primary Care ◽  
Usual Care ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Behaviour Change Techniques ◽  
Current Standard ◽  
Link Type ◽  
Implementation Period ◽  
Full Protocol ◽  
Randomised Controlled

Abstract Objectives To examine the effectiveness of randomising dissemination of the Germ Defence behaviour change website via GP practices across England UK. Trial design A two-arm (1:1 ratio) cluster randomised controlled trial implementing Germ Defence via GP practices compared with usual care. Participants Setting: All Primary care GP practices in England. Participants: All patients aged 16 years and over who were granted access by participating GP practices. Intervention and comparator Intervention: We will ask staff at GP practices randomised to the intervention arm to share the weblink to Germ Defence with all adult patients registered at their practice during the 4-month trial implementation period and care will otherwise follow current standard management. Germ Defence is an interactive website (http://GermDefence.org/) employing behaviour change techniques and practical advice on how to reduce the spread of infection in the home. The coronavirus version of Germ Defence helps people understand what measures to take and when to take them to avoid infection. This includes hand washing, avoiding sharing rooms and surfaces, dealing with deliveries and ventilating rooms. Using behaviour change techniques, it helps users think through and adopt better home hygiene habits and find ways to solve any barriers, providing personalised goal setting and tailored advice that fits users’ personal circumstances and problem solving to overcome barriers. Comparator: Patients at GP practices randomised to the usual care arm will receive current standard management for the 4-month trial period after which we will ask staff to share the link to Germ Defence with all adult patients registered at their practice. Main outcomes The primary outcome is the effects of implementing Germ Defence on prevalence of all respiratory tract infection diagnoses during the 4-month trial implementation period. The secondary outcomes are: 1) incidence of COVID-19 diagnoses 2) incidence of COVID-19 symptom presentation 3) incidence of gastrointestinal infections 4) number of primary care consultations 5) antibiotic usage 6) hospital admissions 7) uptake of GP practices disseminating Germ Defence to their patients 8) usage of the Germ Defence website by individuals who were granted access by their GP practice Randomisation GP practices will be randomised on a 1:1 basis by the independent Bristol Randomised Trials Collaboration (BRTC). Clinical Commission Groups (CCGs) in England will be divided into blocks according to region, and equal numbers in each block will be randomly allocated to intervention or usual care. The randomisation schedule will be generated in Stata statistical software by a statistician not otherwise involved in the enrolment of general practices into the study. Blinding (masking) The principal investigators, the statistician and study collaborators will remain blinded from the identity of randomised practices until the end of the study. Numbers to be randomised (sample size) To detect planned effect size (based on PRIMIT trial, Little et al, 2015): 11.1 million respondents from 6822 active GP practices. Assuming 25% of these GP practices will engage, we will contact all GP practices in England spread across 135 Clinical Commissioning Groups. Trial status Protocol version 2.0, dated 13 January 2021. Implementation is ongoing. The implementation period started on 10 November 2020 and will end on 10 March 2021. Trial registration This trial was registered in the ISRCTN registry (isrctn.com/ISRCTN14602359) on 12 August 2020. 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.

scholarly journals P1: THE VITAL STUDY: A FEASIBILITY STUDY OF A RANDOMISED CONTROLLED TRIAL TO EXAMINE IF VIRTUAL REALITY TECHNOLOGY CAN IMPROVE SURGICAL TRAINING IN SIERRA LEONE

2021 ◽  
Vol 108 (Supplement_1) ◽  
Author(s):  
Keyword(s):  
Virtual Reality ◽  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Full Scale ◽  
Limb Amputation ◽  
Control Group ◽  
Perceived Learning ◽  
Surgical Trainees ◽  
Randomised Controlled

Abstract Introduction Training surgeons is expensive and relies on expert supervision. Virtual reality (VR) may enhance acquisition of knowledge and skills. There is limited evidence on the effectiveness of VR in low and middle-income countries (LMICs). The purpose of this study was to evaluate the technical feasibility of mobile phone VR in LMICs and the feasibility of conducting a full-scale randomised controlled trial. Method A prospective randomised controlled feasibility study was conducted. Surgical trainees were recruited from a government teaching hospital in Freetown in November 2019. Participants were randomised 1:1 VR vs non-VR. These were given one-week prior to a two-day hands-on course on lower limb amputation. The VR training involved two 30-minute modules consisting of narrated live surgery videos. Feasibility outcomes included recruitment rates and VR intervention fidelity and acceptability. Result Thirty participants were randomised to the VR group (n=15) or control group (n=15). Of these, 29 (96.7%) participants completed the course. The recruitment period required was two days. Intervention adherence exceeded defined success rates with 100% of participants completing the intervention. There was no unblinding. Compared to controls, the VR group rated statistically significantly higher engagement during the course in 4/6 domains, increased perceived learning in 5/5 domains and increased engagement with pre-course learning in in 4/6 domains. Conclusion VR is technically feasible in an LMIC setting and improves engagement and perceived learning. With minor modifications to the intervention and assessments, a full-scale trial is feasible. Further exploration is required to determine the best outcome measures to demonstrate effect. Take-home message VR is technically feasible in an LMIC setting and improves engagement and perceived learning. Now we need to explore if it can improve surgical knowledge and skill acquisition on a large scale.

scholarly journals Application of Objective Structured Clinical Examinations (OSCE) for The Evaluation of Kampo Medicine Training

2021 ◽  
Author(s):  
Marie Amitani ◽  
Haruka Amitani ◽  
Hajime Suzuki ◽  
Suguru Kawazu ◽  
Kimiko Mizuma ◽  
...  
Keyword(s):  
Clinical Competence ◽  
Content Validity ◽  
Assessment Method ◽  
Kampo Medicine ◽  
Simulated Patients ◽  
Rater Reliability ◽  
Video Recordings ◽  
Reliable Assessment ◽  
Test Committee ◽  
Objective Structured Clinical Examinations

Abstract Background The purpose of study was to develop an objective, valid, and reliable assessment method for Kampo medicine using an OSCE for the evaluation of clinical competence in Kampo medicine Methods We developed a blueprint followed by a list of 47 assessment items and three task scenarios related to clinical competence in Kampo medicine. An eight-member test committee checked the relevance and pass/fail criteria of the assessment items on a Likert scale. We calculated a content validity index and content validity ratio, and used the Angoff method to set the passing threshold. We trained a total of nine simulated patients with three assigned to each scenario. We conducted an OSCE for 11 candidates with varying medical abilities, and conducted three stations per person, and one evaluator in one room by direct observation evaluated. We used video recordings to test the inter-rater reliability of the three raters. We used the test results to verify the reliability of the evaluation scale. Results The inter-rater reliability (Cronbach’s α) was 0.92–1.00, intra-examinee reliability was 0.59–0.95, and the reliability of each task was 0.86, 0.89, and 0.86 for Scenarios 1, 2, and 3, respectively. Conclusions We developed a content-valid new OSCE assessment method for Kampo medicine and obtained high inter-rater and test reliabilities. Our findings suggest that this is one of the most reliable and valid evaluation methods for assessing clinical competence in Kampo medicine.

scholarly journals DIETETIC MANAGEMENT OF MALNUTRITION IN A HEALTHCARE SETTING: A SIX MONTH PRAGMATIC RANDOMISED CONTROLLED TRIAL WITH A 24 MONTH FOLLOW-UP

2016 ◽  
pp. 1-6
Author(s):  
M. Milosavljevic ◽  
S. Bowden ◽  
A. Ferguson ◽  
L. Barone ◽  
S. Mason ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Nutritional Status ◽  
Nutritional Assessment ◽  
Controlled Trial ◽  
Initial Contact ◽  
Current Standard ◽  
Level Of Satisfaction ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Background: This study explored approaches to long term dietetic management of disease related malnutrition, a growing problem across hospitals in the industrialised world. Objectives: The aim of this study was to compare the effectiveness of two current models of dietetic care for patients with Disease Related Malnutrition. Design: A six month pragmatic randomised controlled trial was conducted with a 24 month follow up. Setting: All patients referred to the dietitian from two general medical and two surgical wards at a major public regional referral centre who met the inclusion criteria were invited to participate. This included being identified on admission as “at risk” of malnutrition or malnourished. Participants: Dietitians attended to 1222 patients during the recruitment period. From 320 eligible participants, 241 (78%) were recruited; of these only 85 (27%) completed the study. Intervention: It compared extended community–based dietetic management with the more traditional short-term hospital care alone. Measurements: A series of variables were recorded at enrolment, six months and then a follow up at 24 months. These included: nutritional assessment, level of satisfaction with the dietetic service, bed day utilisation, readmission and mortality rates. Results: An intention to treat analysis showed both groups had a significant improvement in nutritional status at six months and this was maintained at 24 months. When patients received an extended community care dietetic service they were significantly more satisfied with the dietetic service than those who did not receive the service (P<0.001). Conclusion: The current standard dietetic care of patients admitted to our institution led to significant improvements in their nutritional status at six months and two years from initial contact. The patient’s level of satisfaction with the dietetic service was high when they were seen in the community.

scholarly journals A multicentre, pragmatic, cluster randomised, controlled feasibility trial of the POD system of care

2020 ◽  
Vol 49 (4) ◽  
pp. 640-647
Author(s):  
John Young ◽  
John Green ◽  
Amanda Farrin ◽  
Michelle Collinson ◽  
Suzanne Hartley ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Assessment Method ◽  
System Of Care ◽  
Feasibility Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
New Onset

Abstract Objective to provide a preliminary estimate of the effectiveness of the prevention of delirium (POD) system of care in reducing incident delirium in acute hospital wards and gather data for a future definitive randomised controlled trial. Design cluster randomised and controlled feasibility trial. Setting sixteen acute care of older people and orthopaedic trauma wards in eight hospitals in England and Wales. Participants patients 65 years and over admitted to participating wards during the trial period. Interventions participating wards were randomly assigned to either the POD programme or usual care, determined by existing local policies and practices. The POD programme is a manualised multicomponent delirium prevention intervention that targets 10 risk factors for delirium. The intervention wards underwent a 6-month implementation period before trial recruitment commenced. Main outcome measure incidence of new-onset delirium measured using the Confusion Assessment Method (CAM) measured daily for up to 10 days post consent. Results out of 4449, 3274 patients admitted to the wards were eligible. In total, 714 patients consented (713 registered) to the trial, thirty-three participants (4.6%) withdrew. Adherence to the intervention was classified as at least medium for seven wards. Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37–1.26); P = 0.2225). Conclusions based on these findings, a definitive trial is achievable and would need to recruit 5220 patients in 26 two-ward hospital clusters. Trial registration: ISRCTN01187372. Registered 13 March 2014.

scholarly journals Does Neuromuscular Electrical Stimulation Improve Recovery Following Acute Ankle Sprain? A Pilot Randomised Controlled Trial

2019 ◽  
Vol 12 ◽  
pp. 117954411984902 ◽  
Author(s):  
Thomas W Wainwright ◽  
Louise C Burgess ◽  
Robert G Middleton
Keyword(s):  
Electrical Stimulation ◽  
Randomised Controlled Trial ◽  
Ankle Sprain ◽  
Controlled Trial ◽  
Neuromuscular Electrical Stimulation ◽  
Standard Of Care ◽  
Controlled Study ◽  
Current Standard ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Aim: Following soft tissue ankle injury, patients are often referred for out-patient physiotherapy and present symptoms including pain, reduced range of movement and function, and oedema. In this study, we assess the use of a neuromuscular electrical stimulation (NMES) device as an adjunctive therapy to reduce oedema in patients recovering from grade I and II ankle sprains. Methods: This was a single-centre, pilot randomised controlled study, recruiting patients referred to physiotherapy following an ankle sprain. Participants presenting with oedema were randomised to one of two treatment groups: (1) the current standard of care and (2) the current standard of care plus NMES use. Participants were identified in an emergency department and referred to a physiotherapy department for treatment 1 to 5 days following the injury and returned to clinic 7 days later. Results: Twenty-two participants completed the study and had full data sets for analysis (11 in each group). Mean volumetric displacement was reduced in the intervention group in comparison to the standard care group ( P = .011); however, there were no between-group differences in figure of eight measurements, function or pain scores. The device was well tolerated, with no device-related adverse events recorded. Conclusions: In this pilot, randomised controlled trial, NMES was well tolerated by patients following ankle sprain and demonstrated statistically significant improvements in oedema reduction as measured by fluid displacement. No other changes were observed. Further work will need to confirm the clinical significance and effect on longer term recovery post-ankle sprain.

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