scholarly journals Making large-scale surgical trials possible: collaboration and the role of surgical trainees

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marcus Jepson ◽  
Michelle Lazaroo ◽  
Samir Pathak ◽  
Natalie Blencowe ◽  
Jane Collingwood ◽  
...  
Keyword(s):  
Large Scale ◽  
Descriptive Analysis ◽  
Expectant Management ◽  
Common Bile Duct Stones ◽  
Principal Investigator ◽  
Component Part ◽  
Surgical Trainees ◽  
Formal Framework ◽  
Randomised Controlled ◽  
Motivating Factor

Abstract Background Recruitment to surgical randomised controlled trials (RCTs) can be challenging. The Sunflower study is a large-scale multi-centre RCT that seeks to establish the clinical and cost effectiveness of pre-operative imaging versus expectant management in patients with symptomatic gallstones undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones. Trials such as Sunflower, with a large recruitment target, rely on teamworking. Recruitment can be optimised by embedding a QuinteT Recruitment Intervention (QRI). Additionally, engaging surgical trainees can contribute to successful recruitment, and the NIHR Associate Principal Investigator (API) scheme provides a framework to acknowledge their contributions. Methods This was a mixed-methods study that formed a component part of an embedded QRI for the Sunflower RCT. The aim of this study was to understand factors that supported and hindered the participation of surgical trainees in a large-scale RCT and their participation in the API scheme. It comprised semi-structured telephone interviews with consultant surgeons and surgical trainees involved in screening and recruitment of patients, and descriptive analysis of screening and recruitment data. Interviews were analysed thematically to explore the perspectives of—and roles undertaken by—surgical trainees. Results Interviews were undertaken with 34 clinicians (17 consultant surgeons, 17 surgical trainees) from 22 UK hospital trusts. Surgical trainees contributed to patient screening, approaches and randomisation, with a major contribution to the randomisation of patients from acute admissions. They were often encouraged to participate in the study by their centre principal investigator, and career development was a typical motivating factor for their participation in the study. The study was registered with the API scheme, and a majority of the trainees interviewed (n = 14) were participating in the scheme. Conclusion Surgical trainees can contribute substantial activity to a large-scale multi-centre RCT. Benefits of trainee engagement were identified for trainees themselves, for local sites and for the study as a whole. The API scheme provided a formal framework to acknowledge engagement. Ensuring that training and support for trainees are provided by the trial team is key to optimise success for all stakeholders.

scholarly journals V10 The role of surgical trainees in recruiting to multicentre RCTs: an example from the Sunflower Study

BJS Open ◽  
2021 ◽  
Vol 5 (Supplement_1) ◽  
Author(s):  
Lucy Huppler ◽  
Sarah Staight ◽  
Tomas Urbonas ◽  
Judith Johnston ◽  
Yegor Tryliskyy ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Expectant Management ◽  
Common Bile Duct Stones ◽  
Surgical Trainees ◽  
Number Of Patients ◽  
Research Nurses ◽  
Randomised Controlled ◽  
The Uk ◽  
To Receive

Abstract Background The Sunflower Study aims to compare the effectiveness of expectant management and MRCP prior to laparoscopic cholecystectomy (LC) in patients at low or moderate risk of common bile duct stones. This is the largest surgical randomised controlled trial (RCT) in the UK and a secondary aim is to describe trainees’ contributions. Methods Participants are randomised to receive expectant management or MRCP in a 2:1 ratio. Over 13,500 patients from more than 50 UK hospitals are required over five years. Trainees’ contributions are documented as follows: total number signed up to the study; number enrolled in the NIHR associate PI scheme; and the number of patients approached and recruited. The proportion of ‘emergency’ and ‘elective’ patients recruited was also recorded. Results Sunflower has been open since February 2019 and 48 centres are currently participating. A total of 104 trainees have been actively involved and 34 are/have been enrolled in the associate PI scheme. To date, 3992 patients have been screened, by trainees (n = 719,18%), consultants (n = 439,11%) and research nurses (n = 2214,71%). 1996 patients have been recruited, 359(18%) of which by trainees, 319(16%) consultants and 1318(66%) research nurses. Of the recruited patients, 423 (21%) presented as emergencies, recruited by trainees (n = 169,40%), consultants (n = 59,14%) and research nurses (n = 195,46%). Conclusions Trainees have an important role to play in recruiting patients to multicentre surgical RCTs, in particular in emergency settings, which can help improve studies’ generalisability. The associate PI scheme seems to provide an extra incentive for trainees to be involved in an RCT.

scholarly journals Effects of Delayed Radical Prostatectomy and Active Surveillance on Localised Prostate Cancer—A Systematic Review and Meta-Analysis

Cancers ◽  
2021 ◽  
Vol 13 (13) ◽  
pp. 3274
Author(s):  
Vinson Wai-Shun Chan ◽  
Wei Shen Tan ◽  
Aqua Asif ◽  
Alexander Ng ◽  
Olayinka Gbolahan ◽  
...  
Keyword(s):  
High Risk ◽  
Radical Prostatectomy ◽  
Meta Analysis ◽  
Expectant Management ◽  
Intermediate Risk ◽  
Active Monitoring ◽  
High Risk Patients ◽  
Oncological Outcomes ◽  
Risk Patients ◽  
Randomised Controlled

External factors, such as the coronavirus disease 2019 (COVID-19), can lead to cancellations and backlogs of cancer surgeries. The effects of these delays are unclear. This study summarised the evidence surrounding expectant management, delay radical prostatectomy (RP), and neoadjuvant hormone therapy (NHT) compared to immediate RP. MEDLINE and EMBASE was searched for randomised controlled trials (RCTs) and non-randomised controlled studies pertaining to the review question. Risks of biases (RoB) were evaluated using the RoB 2.0 tool and the Newcastle–Ottawa Scale. A total of 57 studies were included. Meta-analysis of four RCTs found overall survival and cancer-specific survival were significantly worsened amongst intermediate-risk patients undergoing active monitoring, observation, or watchful waiting but not in low- and high-risk patients. Evidence from 33 observational studies comparing delayed RP and immediate RP is contradictory. However, conservative estimates of delays over 5 months, 4 months, and 30 days for low-risk, intermediate-risk, and high-risk patients, respectively, have been associated with significantly worse pathological and oncological outcomes in individual studies. In 11 RCTs, a 3-month course of NHT has been shown to improve pathological outcomes in most patients, but its effect on oncological outcomes is apparently limited.

scholarly journals Can we rely on non-randomised studies? Findings from a meta-epidemiological review

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
J C Rejon-Parrilla ◽  
M Salcher-Konrad ◽  
M Nguyen ◽  
K Davis ◽  
P Jonsson ◽  
...  
Keyword(s):  
Health Economic ◽  
Analytical Methods ◽  
Large Scale ◽  
Treatment Effects ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Risk Of Bias ◽  
Economic Decision Making ◽  
Wide Range ◽  
Randomised Controlled

Abstract Background Increasingly, health technology assessment (HTA) agencies must decide whether new medicines should be used routinely in the absence of randomised controlled trial (RCT) data, relying solely on non-randomised studies (NRS), which are at high risk of bias due to confounding. Against the background of increased availability and improved methods to analyse non-randomised data (e.g., propensity score methods and instrumental variables), it is important for decision-makers to have guidance on the analysis and interpretation of NRS to inform health economic evaluation. We therefore aimed to systematically and empirically assess the performance of NRS using different analytical methods as compared to RCTs and develop recommendations on the basis of our findings. Methods We conducted a large-scale meta-epidemiological review to obtain estimates of the discrepancy in treatment effects in matched RCTs and NRS of pharmacologic interventions from published meta-analyses indexed in MEDLINE and the Cochrane Database of Systematic Reviews. We also consulted with HTA bodies, regulators and academics from five European countries to learn from their experience with using non-randomised evidence. Results We compiled the largest dataset of clinical topics with matching RCTs and NRS using various analytical methods to date, covering >100 unique clinical questions. Incorporating information on direction of effect and effect size from >700 unique studies, the dataset can be used to evaluate discrepancies in treatment effects between study designs across a wide range of therapeutic areas. Conclusions An empirically based understanding of the risk of bias in NRS is required in order to promote the adequate use of non-randomised evidence as input for health economic decision-making.

scholarly journals Effects of a workplace prevention programme for problem gambling: study protocol for a cluster randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e015963 ◽  
Author(s):  
Jonas Rafi ◽  
Ekaterina Ivanova ◽  
Alexander Rozental ◽  
Per Carlbring
Keyword(s):  
Problem Gambling ◽  
Large Scale ◽  
Controlled Trial ◽  
Public Health Problem ◽  
Cluster Randomised Controlled Trial ◽  
Severity Index ◽  
The Body ◽  
Prevention Programme ◽  
Open Access Journals ◽  
Randomised Controlled

IntroductionDespite being considered a public health problem, no prevention programme for problem gambling in workplace settings has been scientifically evaluated. This study aims to fill a critical gap in the field of problem gambling by implementing and evaluating a large-scale prevention programme in organisations.Methods and analysisTen organisations, with a total of n=549 managers and n=8572 employees, will be randomised to either receiving a prevention programme or to a waitlist control condition. Measurements will be collected at the baseline and 3, 12 and 24 months after intervention. The primary outcome of interest is the managers’ inclination to act when worried or suspicious about an employee’s problem gambling or other harmful use. Additional outcomes of interest include the Problem Gambling Severity Index and gambling habits in both managers and employees. Furthermore, qualitative analyses of the responses from semistructured interviews with managers will be performed.Ethics and disseminationThis study has been approved by the regional ethics board of Stockholm, Sweden, and it will contribute to the body of knowledge concerning prevention of problem gambling. The findings will be published in peer-reviewed, open-access journals.Trial registration numberNCT02925286; Pre-results.

Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Hatem Hussein El-Gamal ◽  
Walid El-Basuony Mohammad ◽  
Ahmed Samir Mohamed Zeerban
Keyword(s):  
Quality Of Life ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Expectant Management ◽  
Control Group ◽  
Randomised Controlled ◽  
Caesarean Scar Defect ◽  
Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

Access to Formal Credit in the Indian Agriculture: Does Caste matter?

2018 ◽  
Vol 4 (2) ◽  
pp. 169-195
Author(s):  
Karthick V. ◽  
Madheswaran S.
Keyword(s):  
Large Scale ◽  
Descriptive Analysis ◽  
Social Groups ◽  
Critical Factor ◽  
Credit Market ◽  
Access To Resources ◽  
Access To Credit ◽  
Indian Agriculture ◽  
Discrimination Coefficient ◽  
Lower Castes

Access to resources and opportunities can be a critical factor in improving outcomes for disadvantaged groups. Improving access to financial resources, in particular, is widely acknowledged to facilitate upward economic and social mobility. Conversely, lack of access to resources for certain groups based on caste, class, gender and ethno-social identities can perpetuate inequalities. In this context, this paper attempts to analyse the access to credit by social groups and decomposes the gross credit differentials using Oaxaca-blinder decomposition method using unit-level data from the All India Debt and Investment Survey, NSSO, 2013. The descriptive analysis clearly shows that there is a significant credit differential between forward caste (FC) and other social groups (SC, ST and OBC). Access to credit varies across social groups based on many factors. The decomposition result indicates that the discrimination coefficient against SC is 49per cent which explains that SCs are being discriminated by 49 per cent compared to FCs in the formal credit market. In case of ST, the discrimination coefficient against is 61per cent and for OBC it is 48per cent. Interestingly, the endowment difference is less among ST (38per cent) compared to SC and OBC (around 51 per cent). Also, the FC treatment advantage (benefit of being a FC in the credit market) is 5.7 per cent whereas the cost of being an SC in the credit market (treatment disadvantage) is 35.1 per cent. As expected, the disadvantage component for ST and OBC is 33.1 per cent and 17.8 per cent respectively. Thus, we see that although programmes, schemes and policies to promote the economic empowerment of lower castes through finance have been implemented on a large scale since the 1990s, they have not been very effective.

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.

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