Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation: A randomised controlled trial (2020)

Type of publication:
Conference abstract

Author(s):
Grossi U.; McAlees E.; Knowles C.H.; Stevens N.; Di Tanna G.L.; Marlin N.; *Lacy-Colson J.; Brown S.; Scott S.M.; Norton C.; Mason J.

Citation:
Techniques in Coloproctology; 2020; vol. 24 (no. 4); p. 373-374

Abstract:
Background: Laparoscopic ventral mesh rectopexy (LVMR) is an established treatment for external full-thickness rectal prolapse. However, its clinical efficacy in patients with internal prolapse is uncertain due to the lack of high-quality evidence.
Methods: An individual level, stepped-wedge randomised trial has been designed to allow observer blinded data comparisons between patients awaiting LVMR with those who have undergone surgery. Adults with symptomatic internal rectal prolapse, unresponsive to prior conservative management, will be eligible to participate. They will be randomised to three arms with different delays before surgery (0, 12 and 24 weeks). Efficacy outcome data will be collected at equally stepped time points (12, 24, 36 and 48 weeks). The primary objective is to determine clinical efficacy of LVMR compared to controls with reduction in the Patient Assessment of Constipation Quality of Life (PAC-QOL) at 24 weeks serving as the primary outcome. Secondary objectives are to determine: (1) the clinical effectiveness of LVMR to 48 weeks to a maximum of 72 weeks; (2) preoperative determinants of outcome; (3) relevant health economics for LVMR; (4) qualitative evaluation of patient and health professional experience of LVMR and (5) 30-day morbidity and mortality rates.
Results: An individual-level, stepped-wedge, randomised trial serves the purpose of providing an untreated comparison for the active treatment group, while at the same time allowing the waiting-listed participants an opportunity to obtain the intervention at a later date. Conclusions: In keeping with the basic ethical tenets of this design, the average waiting time for LVMR (12 weeks) will be shorter than that for routine services (24 weeks).

Metabolic stone screening – can education improve adherence to national guidelines? (2020)

Type of publication:
Journal article

Author(s):
Ravindraanandan M.; *Jayawardena P.

Citation:
Journal of Endoluminal Endourology; Jan 2020; vol. 3 (no. 1)

Abstract:
Nephrolithiasis is a common urological disease affecting approximately 13% of the global population. Identifying a preventable cause during follow-up for stone formation is a necessary factor in reducing recurrence. The majority of kidney stones are comprised of calcium, with oxalate and phosphate compounds accounting for approximately 80% of stone formers. Serum analysis can be used to identify the levels of calcium in the blood, excluding metabolic causes for stones. Current NICE guidelines recommend performing a metabolic screen during an acute admission. Adherence to these guidelines from clinicians can be poor. We aim to see whether education can improve serum metabolic requests from clinicians in the UK. Method A case-control study was performed in a single rural district general hospital in the UK. Patients who presented with renal colic were analyzed retrospectively for four months, looking at serum metabolic screen requests. Two months of education was then delivered to acute departments, with a further prospective study performed following this for six months. Outcomes were then compared between both groups to see if there was an improvement in serum requests following the delivery of local education. Results A total of 124 patients were included in our study. 50 patients were analyzed in cohort A over a 4-month period. Complete serum analysis was performed on 22% (n=11) of patients. Incomplete serum analysis was performed on 58% (n-29) of patients with uric acid being missed on all of them. 10 patients had no metabolic serum analysis performed at all, with 1 patient having a previous history of stones. A total of 74 patients were analyzed in cohort B over a 6-month period. This was following the 2 months of departmental education given by urologists. Complete serum analysis was performed on 24% (n=18) of patients. Incomplete serum analysis was performed on 55% (n=41) of patients with uric acid being missed from all of them. The remaining 21% of patients (n=15) had no metabolic serum screen performed at all. There was no significant difference seen between both cohorts after comparing metabolic serum requests before and after department education for 2 months (p=0.7287). Conclusion Improving adherence to clinical guidelines for metabolic screening has proved difficult with departmental teaching alone, with very little improvement achieved. Nevertheless, formal face-to-face education is advocated to reinforce knowledge in junior doctors managing renal stones.

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Providing a safe and effective intravitreal treatment service: strategies for service delivery (2020)

Type of publication:
Journal article

Author(s):
Amoaku W.; Bailey C.; Downey L.; Gale R.P.; Ghanchi F.; Hamilton R.; Mahmood S.; Menon G.; *Nosek J. ; Pearce I.; Yang Y

Citation:
Clinical Ophthalmology; 2020; vol. 14 ; p. 1315-1328

Abstract:
An aging population leads to increasing demand for medical retina services with chronic diseases being managed in long-term care pathways. Many hospital services struggle to deliver efficient and effective MR care due, at least in part, to infrastructure that does not expand responsively enough to meet the increased demand. A steering committee of retinal specialists from a variety of UK NHS hospital ophthalmology departments with experience of leading and managing NHS retinal services in the intravitreal era came together for the generation of this document to review and compile key aspects that should be considered when optimising intravitreal treatment capacity within MR services. This article aims to provide a useful collation and signposting of key published evidence, consensus and insights on aspects of delivering an intravitreal service, including treatment regimens, virtual clinics, staff training and governance, telemedicine and information technology, and data collection and key performance indicators. The objective is to equip ophthalmologic healthcare professionals with the necessary tools to develop and adapt their local service in the face of current and projected increased demand.

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The triple effect of the magseed for localisation of impalpable breast cancer: Significant reduction in re-excision rate, cost saving by reducing further surgery and high patient satisfaction (2020)

Type of publication:
Conference abstract

Author(s):
*Lake B.; *Wilson M.; *Thomas G.; *Williams S.; *Usman T.

Citation:
European Journal of Surgical Oncology; Jun 2020; vol. 46 (no. 6); e12

Abstract:
Introduction: Traditionally impalpable breast cancers have been localised with image guided techniques of wire guidance or ultrasound marking. Magseed is a small magnetic seed which is changing practice of localisation of these cancers. The aim of this study was to see if the change of practice of localisation to Magseed affected patient outcome evaluated by re-excision rate, specimen weight and patient satisfaction. Method(s): A change of practice service evaluation was conducted at the Shrewsbury and Telford Hospital of all patients who had imaged guided wide local excision for impalpable breast cancer from July 2017 to August 2019. Data recorded included tumour demographics, localisation method, size of tumour and specimen weight. Evaluation of localisation methods included re-excision rates, type of further surgery, cost saving in reduction in re-excision, and patient satisfaction. Result(s): 2017/2018 226 Traditional guided WLE were performed. 2018/2019 90 traditional guided WLE, and 106 Magseed WLE were performed. Tumour demographics, size of tumour were similar for localisation methods. The introduction of Magseed in our practice has resulted in a significant reduction in overall re-excision rates from 22.4 to 12%, (z =2.6616 p.00782), and average specimen weight from 40 to 27g (t= -3.2364, P.000716). Cost saving analysis of further surgery showed a saving of 34,457 with 48% less further operations following change of practice. 98% of patients had a very good/excellent experience of Magseed. Conclusion(s): Magseed demonstrates a triple effect on patient outcome with significant reduction in re-excision rate, cost saving by reducing further surgery and high patient satisfaction.

The histopathological correlation of magnetic resonance imaging-identified additional lesions detected in 2nd read breast MRIS (2020)

Type of publication:
Conference abstract

Author(s):
*Aksoy U.; *Barlow E.; *Williams S.; *Lake B.; *Metelko M

Citation:
European Journal of Surgical Oncology; Jun 2020; vol. 46 (no. 6), p. e19

Abstract:
Introduction: Magnetic resonance imaging-identified additional lesions (MRALs) in breast cancer have always been a diagnostic dilemma as they may result in significant delay in management plans and sometimes cause overtreatment. Clinical guidelines for the management of breast cancer in the UK recommend second read MRIs in at least 50% of patients. In this audit project, our aim is to correlate the MRALs reported in 2nd read breast MRIs (2bMRI) with the histopathological outcomes.
Method(s): The patients who were referred to 2bMRIs between July 2018 and August 2019 were retrieved from the archives. 86 consecutive patients (mean age: 54) were included in the audit. First read MRIs were correlated with 2bMRI results and noted as; agreed, a larger lesion (>1cm) or additional foci reported, a smaller lesion or fewer number of additional foci reported. According to histopathology reports MRALs were classified as; proved malignant, benign or not applicable.
Result(s): In 80% (69/86) of the patients the 2bMRI reports agreed with the first and the management did not change. In 20% there was disagreement. Five true positive cases benefited from more extensive surgery. Eight false positive cases ended up with more extensive surgery.
Conclusion(s): Referral indications were in accordance with the guidelines and 5.8% of the patients benefited from the 2bMRIs. However, a significant number of the patients did not benefit from the 2bMRIs. Larger studies are needed to see the true benefit of 2bMRIs as they have the potential to delay the patient pathway and increase anxiety levels of breast cancer patients.

Three-dimensional versus two-dimensional imaging during laparoscopic cholecystectomy: a systematic review and meta-analysis of randomised controlled trials (2020)

Type of publication:
Systematic Review

Author(s):
*Davies S.; Ghallab M.; Hajibandeh S.; Hajibandeh S.; Addison S.

Citation:
Langenbeck’s Archives of Surgery; 2020

Abstract:
Objectives: To evaluate the comparative outcomes of three-dimensional (3D) versus two-dimensional (2D) imaging during laparoscopic cholecystectomy.
Method(s): We conducted a systematic search of electronic information sources and bibliographic reference lists and applied a combination of free text and controlled vocabulary search adapted to thesaurus headings, search operators and limits. Procedure time, Calot’s triangle dissection time, gallbladder removal time, gallbladder perforation, intraoperative bleeding, postoperative complications, conversion to open and intraoperative errors were the evaluated outcome parameters.
Result(s): We identified 6 randomised controlled trials (RCT) reporting a total of 577 patients who underwent laparoscopic cholecystectomy using 3D (n = 282) or 2D (n = 295) imaging. The 3D imaging was associated with significantly shorter procedure time (MD – 4.23, 95% CI – 8.14 to – 0.32, p = 0.03), Calot’s triangle dissection time (MD – 4.19, 95% CI – 6.52 to – 1.86, p = 0.0004) and significantly lower risk of gallbladder perforation (RR 0.50, 95% CI 0.28-0.88, p = 0.02) compared to the 2D approach. No significant difference was found in gallbladder removal time (MD – 0.79, 95% CI – 2.24 to 0.66, p = 0.28), intraoperative bleeding (RR 1.14, 95% CI 0.68-1.90, p = 0.61), postoperative complications (RD – 0.01, 95% CI – 0.06 to 0.05, p = 0.85), conversion to open (RD 0.00, 95% CI – 0.02 to 0.03, p = 0.70) or intraoperative errors (RR 0.96, 95% CI 0.79-1.17, p = 0.70) between the two groups.
Conclusion(s): Although our findings suggest that the use of 3D imaging during laparoscopic cholecystectomy may be associated with significantly shorter procedure time, Calot’s triangle dissection time and gallbladder injury compared to the 2D imaging, the differences seem to be clinically insignificant. Moreover, both approaches carry s similar risk of postoperative morbidities. The impact of the surgeon’s level of experience and difficulty of the procedure on the outcomes of each imaging modality remains unknown.

Routine Use of Swallowing Outcome Measures Following Head and Neck Cancer in a Multidisciplinary Clinic Setting (2020)

Type of publication:
Journal article

Author(s):
*Annette C. Zuydam, Simon N. Rogers, Kate Grayson, *Clare F. Probert

Citation:
International Archives of Otorhinolaryngology, May 2020 [epub ahead of print]

Abstract:
Introduction: Chemoradiotherapy treatment for head and neck cancer (HNC) can have a major impact on swallowing function and health-related quality of life. The use of outcome measures in early detection of patients with swallowing problems provides the opportunity for targeting speech and language therapy (SLT) interventions to aid adaption and promote better clinical outcomes.
Objective: The purpose of the present study was to assess relationships between four outcomes measures over time, in a cohort of HNC patients, treated by (chemo-) radiotherapy.
Methods: Data were collected at 3 months and 12 months, on 49 consecutive patients with primary squamous cell cancer of the oropharynx, nasopharynx or hypopharynx stage T1–4, N0–2b, M0 disease.
Results: Out of 49 eligible patients, 45 completed assessment at 3 months and 20 at 12 months. The 3-month outcomes gave a strong indication of performance at 1 year. There were several strong correlations found between measures. The strongest was between the 3-month Performance Status Scale for Head and Neck Cancer (PSSHN) and the 12-month PSSHN (rs ¼ 0.761, n ¼ 17), the 12-month PSSHN and the 12-month
Functional Oral Intake Scale (FOIS) (rs ¼ 0.823, n ¼ 20), and the 12-month University of Washington Head and Neck Quality of Life (UWQoL) swallow and the 12-month Water Swallow Test (WST) capacity (rs ¼ 0.759, n ¼ 17).
Conclusion: The UW-QoL swallow item and WST are easy to incorporate into routine care and should be used as part of a standard assessment of swallow outcome. These measures can serve to help screen patients for dysfunction and focus allocation of resources for those who would benefit from more comprehensive assessment and intervention by SLT.

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Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial (2020)

Type of publication:
Randomised controlled trial

Author(s):
The HALT-IT Trial Collaborators (including *John Jones and *Charlotte Owen)

Citation:
Lancet, 2020; Vol. 395: pp. 1927–36

Abstract:
Background: Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding.
Methods: We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124.
Findings: Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid
(5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11952 (99·5%) received the first dose of the allocated
treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the
tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82–1·18).
Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and
placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein
thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of
5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98).
Interpretation: We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our
results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a
randomised trial.

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The Prevalence of Thyroid Dysfunction and Autoimmunity in Women With History of Miscarriage or Subfertility (2020)

Type of publication:
Journal article

Author(s):
Rima K Dhillon-Smith, Aurelio Tobias, Paul P Smith, Lee J Middleton, Kirandeep K Sunner, Krystyna Baker, Samantha Farrell-Carver, Ruth Bender-Atik, Rina Agrawal, Kalsang Bhatia, Justin J Chu, Edmond Edi-Osagie, Ayman Ewies, Tarek Ghobara, Pratima Gupta, Davor Jurkovic, Yacoub Khalaf, Khashia Mulbagal, Natalie Nunes, Caroline Overton, Siobhan Quenby, Raj Rai, Nick Raine-Fenning, Lynne Robinson, Jackie Ross, Andrew Sizer, Rachel Small, *Martyn Underwood, Mark D Kilby, Jane Daniels, Shakila Thangaratinam, Shiao Chan, Kristien Boelaert, Arri Coomarasamy

Citation:
The Journal of Clinical Endocrinology & Metabolism, Volume 105, Issue 8, August 2020

Abstract:
Objective: To describe the prevalence of and factors associated with different thyroid dysfunction phenotypes in women who are asymptomatic preconception.
Design: Observational cohort study.
Setting: A total of 49 hospitals across the United Kingdom between 2011 and 2016.
Participants: Women aged 16 to 41 years with history of miscarriage or subfertility trying for a pregnancy.
Methods: Prevalences and 95% confidence intervals (CIs) were estimated using the binomial exact method. Multivariate logistic regression analyses were conducted to identify risk factors for thyroid disease.
Intervention: None.
Main Outcome Measure: Rates of thyroid dysfunction.
Results: Thyroid function and thyroid peroxidase antibody (TPOAb) data were available for 19213 and 19237 women, respectively. The prevalence of abnormal thyroid function was 4.8% (95% CI, 4.5-5.1); euthyroidism was defined as levels of thyroid-stimulating hormone (TSH) of 0.44 to 4.50 mIU/L and free thyroxine (fT4) of 10 to 21 pmol/L. Overt hypothyroidism (TSH > 4.50 mIU/L, fT4 < 10 pmol/L) was present in 0.2% of women (95% CI, 0.1-0.3) and overt hyperthyroidism (TSH < 0.44 mIU/L, fT4 > 21 pmol/L) was present in 0.3% (95% CI, 0.2-0.3). The prevalence of subclinical hypothyroidism (SCH) using an upper TSH concentration of 4.50 mIU/L was 2.4% (95% CI, 2.1-2.6). Lowering the upper TSH to 2.50 mIU/L resulted in higher rates of SCH, 19.9% (95% CI, 19.3-20.5). Multiple regression analyses showed increased odds of SCH (TSH > 4.50 mIU/L) with body mass index (BMI) ≥ 35.0 kg/m2 (adjusted odds ratio [aOR] 1.71; 95% CI, 1.13-2.57; P = 0.01) and Asian ethnicity (aOR 1.76; 95% CI, 1.31-2.37; P < 0.001), and increased odds of SCH (TSH ≥ 2.50 mIU/L) with subfertility (aOR 1.16; 95% CI, 1.04-1.29; P = 0.008). TPOAb positivity was prevalent in 9.5% of women (95% CI, 9.1-9.9).
Conclusions: The prevalence of undiagnosed overt thyroid disease is low. SCH and TPOAb are common, particularly in women with higher BMI or of Asian ethnicity. A TSH cutoff of 2.50 mIU/L to define SCH results in a significant proportion of women potentially requiring levothyroxine treatment.

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