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 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 A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study

2017 ◽  
Vol 21 (70) ◽  
pp. 1-224 ◽  
Author(s):  
Angus JM Watson ◽  
Jonathan Cook ◽  
Jemma Hudson ◽  
Mary Kilonzo ◽  
Jessica Wood ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Stapled Haemorrhoidopexy ◽  
Short Term ◽  
Haemorrhoidal Disease ◽  
Randomised Controlled ◽  
The Uk ◽  
To Receive

BackgroundHaemorrhoids are a benign anorectal condition and are highly prevalent in the UK population. Treatments involve clinic-based procedures and surgery. The surgical procedures available include stapled haemorrhoidopexy (SH) and traditional haemorrhoidectomy (TH), and over 25,000 operations are performed for haemorrhoids annually in the UK. The disease is therefore important both to patients and to health service commissioners. Debate remains as to which of these surgical procedures is the most clinically effective and cost-effective.ObjectiveThe aim of this study was to compare the clinical effectiveness and cost-effectiveness of SH with that of TH.DesignA large, open two-arm parallel-group pragmatic multicentre randomised controlled trial involving 32 UK hospitals and a within-trial cost–benefit analysis. A discrete choice experiment was conducted to estimate benefits (willingness to pay).ParticipantsPatients with grades II–IV haemorrhoids who had not previously undergone SH or TH were included in the study.InterventionsParticipants were randomised to receive either SH or TH. Randomisation was minimised at 1 : 1, in accordance with baseline EuroQol-5 Dimensions, three-level version (EQ-5D-3L) score, haemorrhoid grade, sex and centre, via an automated system.Main outcome measuresThe primary outcome was area under the quality-of-life curve measured using the EQ-5D-3L descriptive system over 24 months, and the primary economic outcome was the incremental cost-effectiveness ratio. Secondary outcomes included disease-specific quality of life, recurrence, complications, further interventions and costs.ResultsBetween January 2011 and August 2014, 777 patients were randomised (389 to receive SH and 388 to receive TH). There were 774 participants included in the analysis as a result of one post-randomisation exclusion in the SH arm and two in the TH arm. SH was less painful than TH in the short term. Surgical complications were similar in both arms. EQ-5D-3L score was higher for the SH arm in the first 6 weeks after surgery, but over 24 months the TH group had significantly better EQ-5D-3L scores (–0.073, 95% confidence interval –0.140 to –0.006;p = 0.0342). Symptoms and further interventions were significantly fewer in the TH arm at 24 months. Continence was better in the TH arm and tenesmus occurred less frequently. The number of serious adverse events reported was 24 out of 337 (7.1%) for participants who received SH and 33 out of 352 (9.4%) for those who received TH. There were two deaths in the SH arm, both unrelated to the eTHoS (either Traditional Haemorrhoidectomy or Stapled haemorrhoidopexy for haemorrhoidal disease) study. Patient preference did not seem to influence the treatment difference. SH was dominated by TH as it cost more and was less effective. The net benefit for the TH arm was higher than that for the SH arm.LimitationsNeither the participants nor the assessors were masked to treatment assignment and final recruitment was slightly short of the total target of 800. There were also substantial missing follow-up data.ConclusionsWhile patients who received SH had less short-term pain, after 6 weeks, recurrence rates, symptoms, re-interventions and quality-of-life measures all favoured TH. In addition, TH is cheaper. As part of a tailored management plan for haemorrhoids, TH should be considered over SH as the surgical treatment of choice for haemorrhoids refractory to clinic-based interventions.Future workPerform an updated meta-analysis incorporating recently conducted European trials [eTHoS, HubBLe (haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids) and LingaLongo (Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease)].Trial registrationCurrent Controlled Trials ISRCTN80061723.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 70. See the NIHR Journals Library website for further project information.

scholarly journals Does hair curl variation influence the efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia in breast cancer patients? A randomised pilot trial

2021 ◽  
Vol 5 ◽  
Author(s):  
Odirile Obuseng ◽  
Nonhlanhla Khumalo ◽  
Thurandrie Naiker ◽  
Tselane Thebe
Keyword(s):  
Controlled Trial ◽  
Pilot Trial ◽  
Scalp Cooling ◽  
Breast Cancer Patients ◽  
Intention To Treat ◽  
Number Of Patients ◽  
Curly Hair ◽  
Randomised Controlled ◽  
And Control ◽  
To Receive

Background: Scalp cooling is reported to reduce Chemotherapy-induced alopecia (CIA).Aim: To compare the efficacy of scalp cooling for straight versus curly hair in a pilot trail.Setting: A radiation oncology breast cancel clinic.Methods: This 20-month randomised controlled trial recruited females (18–65 years) to receive chemotherapy (Adriamycin or Epirubicin and Cyclophosphamide followed by Paclitaxel) with or without scalp cooling. Outcomes were percentage alopecia (Severity ALopecia Tool) by hair curvature and treatment retention.Results: Forty eight patients (24 per group) were randomised; four in each group withdrew before first study visit and photographs of three in the cooling group could not be found for assessment. Thus 77% constituted the intention-to-treat population (17 cooling vs. 20 control). Agreement on alopecia severity was good overall (intra-class correlation coefficient [ICC] = 0.94; 95% confidence interval [CI]: 0.85–0.97) and at six of seven time points. Overall, cooling significantly reduced CIA, relative to no-cooling (58.15 ± 28.46 vs. 37.29 ± 20.52; p = 0.0167); however, percentage alopecia was cosmetically significant. There was no difference in CIA between cooling participants with straight (n = 8) versus curly hair (n = 9), (p = 0.0740).The number of patients completing the various cycles of chemotherapy declined from 77.1% at cycle 1 to 18.8% at cycle 7 for the whole study, and from 100% each to 17.6% and 30.0% for cooling and control groups, respectively (p = 0.451).Conclusion: This study suggests that hair curvature has no significant impact on the efficacy of scalp cooling to reduce CIA, however, this requires confirmation.

scholarly journals Comparison of the Outcome and Treatment of Psychosis in People of Caribbean Origin Living in the Uk and British Whites

2001 ◽  
Vol 178 (2) ◽  
pp. 160-165 ◽  
Author(s):  
K. McKenzie ◽  
C. Samele ◽  
E. Van Horn ◽  
T. Tattan ◽  
J. Van Os ◽  
...  
Keyword(s):  
Risk Factors ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Self Harm ◽  
Symptomatic Outcome ◽  
Receive Treatment ◽  
Randomised Controlled ◽  
The Uk ◽  
To Receive ◽  
Benign Course

BackgroundThe comparative outcome of psychosis in British Whites and UK African-Caribbeans is unclear. Some report that African-Caribbeans have worse outcome, whereas others claim better symptomatic outcome and a more benign course.AimsTo compare the course, outcome and treatment of psychosis in African-Caribbeans and British Whites in a large multi-centre sample.MethodA secondary analysis of 708 patients with research diagnostic criteria-defined psychosis from a 2-year, randomised controlled trial of case management. Outcome measures (hospitalisation, illness course, self-harm, social disability and treatment received) were adjusted for socio-economic and clinical differences between groups at baseline using regression analysis.ResultsAfrican–Caribbeans were less likely to have a continuous illness and to receive treatment with antidepressants or psychotherapy.ConclusionsThe outcome of psychosis is complex but differs between UK African–Caribbeans and British Whites. This may reflect risk factors that increase the rate of psychosis in UK African–Caribbeans. Treatment differences require further investigation.

scholarly journals Mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation only prior rectal surgery (MOBILE2): a multicentre, double-blinded, randomised controlled trial—study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e051269
Author(s):  
Laura Koskenvuo ◽  
Pipsa Lunkka ◽  
Pirita Varpe ◽  
Marja Hyöty ◽  
Reetta Satokari ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Rectal Surgery ◽  
Mechanical Bowel Preparation ◽  
Oral Antibiotic ◽  
Oral Antibiotics ◽  
Number Of Patients ◽  
Randomised Controlled ◽  
Double Blinded

IntroductionMechanical bowel preparation (MBP) prior to rectal surgery is widely used. Based on retrospective data many guidelines recommend mechanical and oral antibiotic bowel preparation (MOABP) to reduce postoperative complications and specifically surgical site infections (SSIs). The primary aim of this study is to examine whether MOABP reduces complications of rectal surgery.Methods and analysisThe MOBILE2 (Mechanical Bowel Preparation and Oral Antibiotics vs Mechanical Bowel Preparation Only Prior Rectal Surgery) trial is a multicentre, double-blinded, parallel group, superiority, randomised controlled trial comparing MOABP to MBP among patients scheduled for rectal surgery with colorectal or coloanal anastomosis. The patients randomised to the MOABP group receive 1 g neomycin and 1 g metronidazole two times on a day prior to surgery and patients randomised to the MBP group receive identical placebo. Based on power calculations, 604 patients will be enrolled in the study. The primary outcome is Comprehensive Complication Index within 30 days after surgery. Secondary outcomes are SSIs within 30 days after surgery, the number and classification of anastomosis dehiscences, the length of hospital stay, mortality within 90 days after surgery and the number of patients who received adjuvant treatment if needed. Tertiary outcomes are overall survival, disease-specific survival, recurrence-free survival and difference in quality-of-life before and 1 year after surgery. In addition, the microbiota differences in colon mucosa are analysed.Ethics and disseminationThe Ethics Committee of Helsinki University Hospital approved the study. The findings will be disseminated in peer-reviewed academic journals.Trial registration numberNCT04281667.

Protocol for a feasibility randomised controlled trial comparing cognitive functional therapy with usual physiotherapy care in people with persistent low back pain

2021 ◽  
pp. 1-14
Author(s):  
Christopher Newton ◽  
Gurpreet Singh ◽  
David Nolan ◽  
Vicky Booth ◽  
Claire Diver ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Low Back ◽  
Functional Therapy ◽  
Randomised Controlled ◽  
The Uk ◽  
Feasibility Rct

BACKGROUND: Combined physical and psychological programmes (CPPP) are recommended for people with disabling low back pain (LBP). Cognitive Functional Therapy (CFT) is a physiotherapist-led low intensity CPPP with positive effects in previous studies. The clinical and cost effectiveness of CFT has not previously been evaluated in a randomised controlled trial (RCT) in the United Kingdom (UK) National Health Service (NHS). Before a definitive RCT can be completed it is necessary to determine if completing such a study is possible. PURPOSE: To determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care for people with persistent LBP in the UK NHS. METHODS: A pragmatic two-arm parallel feasibility RCT comparing CFT with usual physiotherapy care for people with persistent LBP will be completed. Sixty participants will be randomly allocated to receive CFT or usual physiotherapy care. The primary outcome will be feasibility of completing a definitive RCT. Participant reported outcome measures will be recorded at baseline, three, six and twelve-month follow-up, including disability, pain intensity, quality of life and psychosocial function. Data will be analysed descriptively. A qualitative process evaluation will explore the acceptability of the research processes and interventions. DISCUSSION: The rationale and methodological design of a mixed methods feasibility RCT is presented. This study aims to inform the planning, design and completion of a future definitive RCT in the UK NHS. The results will be disseminated through peer reviewed open access journal publication.

scholarly journals National survey of feasibility of NIV trials for management of children with bronchiolitis

2020 ◽  
Vol 4 (1) ◽  
pp. e000780
Author(s):  
Anna Rosala-Hallas ◽  
Ashley P Jones ◽  
Emma Bedson ◽  
Vanessa Compton ◽  
Ricardo M Fernandes ◽  
...  
Keyword(s):  
National Survey ◽  
Controlled Trial ◽  
Management Strategies ◽  
Eligibility Criteria ◽  
Training Requirements ◽  
Non Invasive Ventilation ◽  
Respiratory Management ◽  
Randomised Controlled ◽  
The Uk ◽  
Future Work

BackgroundBronchiolitis is a major cause of admission to hospital in children. Non-invasive ventilation (NIV) support with continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) oxygen is routinely used for infants in the UK with bronchiolitis.ObjectiveTo establish UK paediatric practice regarding management of bronchiolitis, and to explore issues pertinent to the design of a potential future randomised controlled trial of NIV.DesignScreening logs were completed in hospitals in England capturing information on paediatric bronchiolitis admissions. An online national survey of clinical practice was disseminated to healthcare professionals (HCPs) across the UK to ascertain current management strategies.ResultsScreening logs captured data on 393 infants from 8 hospitals. Reasons for admission were most commonly respiratory distress and/or poor fluid intake. Oxygen was administered for 54% of admissions. Respiratory (CPAP and HFNC) and non-respiratory support administered varied considerably. The national survey was completed by 111 HCPs from 76 hospitals. Data were obtained on criteria used to commence and wean NIV, responsibilities for altering NIV settings, minimum training requirements for staff managing a child on NIV, and numbers of trained staff. Most centres were interested in and capable of running a trial of NIV, even out of normal office hours.ConclusionsRespiratory and non-respiratory management of bronchiolitis in UK centres varies widely. A trial of HFNC oxygen therapy in this group of patients is feasible and HCPs would be willing to randomise patients into such a trial. Future work should focus on defining trial eligibility criteria.

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