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Expansile Endocervical Crypt Involvement by CIN2-3 as a Risk Factor for High Grade Cytology Recurrence after Cold Coagulation Cervical Treatment (2020)

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Type of publication:
Journal article

Author(s):
*Papoutsis D.; *Underwood M.; *Parry-Smith W.; *Panikkar J.; *Williams J.

Citation:
Geburtshilfe und Frauenheilkunde; Sep 2020; vol. 80 (no. 9); p. 891-895

Abstract:
Introduction: To determine whether expansile endocervical crypt involvement (ECI) on pretreatment cervical punch biopsies is a risk factor for high grade cytology recurrence in women following cold coagulation for cervical intraepithelial neoplasia (CIN).Materials and Methods: This was a secondary analysis on the results of an observational study of women who had a single cold coagulation cervical treatment between 2001–2011 and who were followed up for cytology recurrence. Women with a previous cervical treatment were excluded.
Results: 559 women were identified with a mean age of 28.7 ± 6.2 years. Expansile and non-expansile ECI were identified in 5.4 and 4.3% of women, respectively. The proportion of women with high grade cytology recurrence was 10% for those with expansile ECI and 2.3% for those without. Multivariate analysis showed that women with expansile ECI when compared to those without, had a four-fold greater risk for high grade cytology recurrence (HR = 4.22; 95% CI: 1.10–16.29, p = 0.036). There was no significant association found between non-expansile ECI and overall or high grade cytology recurrence. The increased biopsy depth and the CIN3 grade of pretreatment cervical punch biopsies were significantly associated with greater odds for the detection of expansile ECI. We calculated that the optimal-cut off of pretreatment cervical punch biopsy depth for the detection of expansile ECI was 4 mm (sensitivity: 73.3%; specificity: 55.1%).
Conclusions: Expansile ECI is a risk factor that increases the likelihood of high grade cytology recurrence following cold coagulation. Deeper pretreatment cervical punch biopsies need to be taken so as not to miss expansile ECI prior to ablative treatment.

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A minimum dataset for a level 1 echocardiogram: A guideline protocol from the british society of echocardiography (2020)

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Type of publication:
Journal article

Author(s):
Hindocha R.; Garry D.; Short N.; *Ingram T.E.; Steeds R.P.; Colebourn C.L.; Pearce K.; Sharma V.

Citation:
Echo Research and Practice; Jun 2020; vol. 7 (no. 2)

Abstract:
The British Society of Echocardiography has previously outlined a minimum dataset for a standard transthoracic echocardiogram, and this remains the basis on which an echocardiographic study should be performed. The importance of ultrasound in excluding critical conditions that may require urgent treatment is well known. Several point-of-care echo protocols have been developed for use by non-echocardiography specialists. However, these protocols are often only used in specific circumstances and are usually limited to 2D echocardiography. Furthermore, although the uptake in training for these protocols has been reasonable, there is little in the way of structured support available from accredited sonographers in the ongoing training and reaccreditation of those undertaking these point-of-care scans. In addition, it is well recognised that the provision of echocardiography on a 24/7 basis is extremely challenging, particularly outside of tertiary cardiac centres. Consequently, following discussions with NHS England, the British Society of Echocardiography has developed the Level 1 echocardiogram in order to support the rapid identification of critical cardiac pathology that may require emergency treatment. It is intended that these scans will be performed by non-specialists in echocardiography and crucially are not designed to replace a full standard transthoracic echocardiogram. Indeed, it is expected that a significant number of patients, in whom a Level 1 echocardiogram is required, will need to have a full echocardiogram performed as soon as is practically possible. This document outlines the minimum dataset for a Level 1 echocardiogram. The accreditation process for Level 1 echo is described separately.

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Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial (2020)

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Type of publication:
Randomised controlled trial

Author(s):
Chu, Justin J; Devall, Adam J; Beeson, Leanne E; Hardy, Pollyanna; Cheed, Versha; Sun, Yongzhong; Roberts, Tracy E; Ogwulu, C Okeke; Williams, Eleanor; Jones, Laura L; La Fontaine Papadopoulos, Jenny H; Bender-Atik, Ruth; Brewin, Jane; Hinshaw, Kim; Choudhary, Meenakshi; Ahmed, Amna; Naftalin, Joel; Nunes, Natalie; Oliver, Abigail; Izzat, Feras; Bhatia, Kalsang; Hassan, Ismail; Jeve, Yadava; Hamilton, Judith; Deb, Shilpa; Bottomley, Cecilia; Ross, Jackie; Watkins, Linda; *Underwood, Martyn; Cheong, Ying; Kumar, Chitra S; Gupta, Pratima; Small, Rachel; Pringle, Stewart; Hodge, Frances; Shahid, Anupama; Gallos, Ioannis D; Horne, Andrew W; Quenby, Siobhan; Coomarasamy, Arri

Citation:
Lancet; Sep 2020; vol. 396 (no. 10253); p. 770-778

Abstract:
BACKGROUND The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone. METHODS MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m2vs ≥35 kg/m2), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024. FINDINGS Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups. INTERPRETATION Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery. FUNDING UK National Institute for Health Research Health Technology Assessment Programme.

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Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer (2020)

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Type of publication:
Randomised controlled trial

Author(s):
Brunt A.M.; Haviland J.S.; Sydenham M.; Bliss J.M.; *Agrawal R.K.; Algurafi H.; Alhasso A.; Barrett-Lee P.; Passant H.; Bliss P.; Bloomfield D.; Tremlett J.; Bowen J.; Donovan E.; Goodman A.; Harnett A.; Hogg M.; Kumar S.; Quigley M.; Sherwin L.; Stewart A.; Syndikus I.; Tsang Y.; Venables K.; Wheatley D.; Yarnold J.R.

Citation:
Journal of Clinical Oncology; October 2020, 38, no. 28, 3261-3272.

Abstract:
PURPOSE: Previous studies of hypofractionated adjuvant whole-breast radiotherapy for early breast cancer established a 15- or 16-fraction (fr) regimen as standard. The FAST Trial (CRUKE/04/015) evaluated normal tissue effects (NTE) and disease outcomes after 5-fr regimens. Ten-year results are presented. METHOD(S): Women >= 50 years of age with low-risk invasive breast carcinoma (pT1-2 pN0) were randomly assigned to 50 Gy/25 fr (5 weeks) or 30 or 28.5 Gy in 5 fr of 6.0 or 5.7 Gy (1 week). The primary end point was change in photographic breast appearance at 2 and 5 years; secondary end points were physician assessments of NTE and local tumor control. Odds ratios (ORs) from longitudinal analyses compared regimens. RESULT(S): A total of 915 women were recruited from 18 UK centers (2004-2007). Five-year photographs were available for 615/862 (71%) eligible patients. ORs for change in photographic breast appearance were 1.64 (95% CI, 1.08 to 2.49; P = .019) for 30 Gy and 1.10 (95% CI, 0.70 to 1.71; P = .686) for 28.5 Gy versus 50 Gy. alpha/beta estimate for photographic end point was 2.7 Gy (95% CI, 1.5 to 3.9 Gy), giving a 5-fr schedule of 28 Gy (95% CI, 26 to 30 Gy) estimated to be isoeffective with 50 Gy/25 fr. ORs for any moderate/marked physician-assessed breast NTE (shrinkage, induration, telangiectasia, edema) were 2.12 (95% CI, 1.55 to 2.89; P < .001) for 30 Gy and 1.22 (95% CI, 0.87 to 1.72; P = .248) for 28.5 Gy versus 50 Gy. With 9.9 years median follow-up, 11 ipsilateral breast cancer events (50 Gy: 3; 30 Gy: 4; 28.5 Gy: 4) and 96 deaths (50 Gy: 30; 30 Gy: 33; 28.5 Gy: 33) have occurred. CONCLUSION(S): At 10 years, there was no significant difference in NTE rates after 28.5 Gy/5 fr compared with 50 Gy/25 fr, but NTE were higher after 30 Gy/5 fr. Results confirm the published 3-year findings that a once-weekly 5-fr schedule of whole-breast radiotherapy can be identified that appears to be radiobiologically comparable for NTE to a conventionally fractionated regimen.

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First impressions of the foundation interim year 1 postings: positives, pitfalls, and perils (2020)

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Type of publication:
Journal article

Author(s):
Youssef S.; Zaidi S.; Varghese C.; Rajagopalan S.; *Shrestha S.

Citation:
Medical Education Online; Dec 2020; vol. 25 (no. 1)

Abstract:
COVID-19 has placed an increased burden on the NHS. Changes were made to expand patient capacity including hospital restructuring, cancellation of most elective surgeries and early graduation of final year medical students. 1 The UK foundation programme (UKFP) curated a new training position for graduates as foundation interim year 1 (FiY1) doctors, where they voluntarily work in paid positions prior to entering formal foundation year 1 (FY1) roles. 2 Expediting the process of fulfilling these positions, the General Medical Council facilitated early provisional registration of doctors. We discuss the positives, pitfalls, and perils of the new roles and the first impressions of three newly qualified FiY1 s in medical, obstetrics and gynaecology and surgical posts, a surgical FY1 doctor and a clinical supervisor in surgery.

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

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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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Routine Use of Swallowing Outcome Measures Following Head and Neck Cancer in a Multidisciplinary Clinic Setting (2021)

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Type of publication:
Journal article

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

Citation:
International Archives of Otorhinolaryngology, 2021; 25(02): e185-e192

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)

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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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'You have got a foreign body in there': Renal transplantation, unexpected mild-to-moderate distress and patients' support needs: A qualitative study (2020)

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Type of publication:
Journal article

Author(s):
Jones J.; Damery S.; Combes G.; Allen K.; *Nicholas J. ; Baharani J.

Citation:
BMJ Open; Mar 2020; vol. 10 (no. 3)

Abstract:
Objective: To explore why transplant patients experience unexpected mild-to-moderate distress and what support they may need.
Design: Qualitative study using individual in-depth interviews. Setting Four National Health Service (NHS) Trusts in the Midlands, UK. Participants Fifteen renal transplant patients meeting the criteria for mild-to-moderate distress from their responses to emotion thermometers. Main outcome measures Identification of the reasons for distress and support options acceptable to renal transplant patients.
Results: Three themes were interpreted from the data: I am living with a "foreign body" inside me', why am I distressed?' and different patients want different support'. Following their transplant, participants felt that they should be happy and content, but this was often not the case. They described a range of feelings about their transplant, such as uncertainty about the lifespan of their new kidney, fear of transplant failure or fear of the donor having health conditions that may transfer to them. A few experienced survivors' guilt when others they had met at the dialysis unit had not received a transplant or because someone had died to enable them to receive the transplant. No longer having regular contact with the renal unit made participants feel isolated. Some participants did not initially attribute the source of their distress to their transplant. Participants' preferred support for their distress and their preferences about who should deliver it varied from peer support to seeing a psychologist.
Conclusions: Raising the issue of post-transplant mild-to-moderate distress with patients and encouraging them to think about and plan coping strategies pretransplant may prove beneficial for the patient and healthcare provider. Patients should be able to choose from a variety of support options.

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Age and Tightness of Repair Are Predictors of Heel-Rise Height After Achilles Tendon Rupture (2020)

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Type of publication:
Journal article

Author(s):
*Carmont, Michael R.; Zellers, Jennifer A.; Brorsson, Annelie; Nilsson-Helander, Katarina; Karlsson, Jón; Grävare Silbernagel, Karin

Citation:
Orthopaedic Journal of Sports Medicine; Mar 2020; vol. 8 (no. 3); p. 1-8

Abstract:
Background: Achilles tendon rupture leads to weakness of ankle plantarflexion. Treatment of Achilles tendon rupture should aim to restore function while minimizing weakness and complications of management. Purpose: To determine the influence of factors (age, sex, body mass index [BMI], weight, time from injury to operative repair, and tightness of repair) in the initial surgical management of patients after an acute Achilles tendon rupture on 12-month functional outcome assessment after percutaneous and minimally invasive repair. Study Design: Cohort study; Level of evidence, 3. Methods: From May 2012 to January 2018, patients sustaining an Achilles tendon rupture receiving operative repair were prospectively evaluated. Tightness of repair was quantified using the intraoperative Achilles tendon resting angle (ATRA). Heel-rise height index (HRHI) was used as the primary 12-month outcome variable. Secondary outcome measures included Achilles tendon total rupture score (ATRS) and Tegner score. Stepwise multiple regression was used to create a model to predict 12-month HRHI. Results: A total of 122 patients met the inclusion criteria for data analysis (mean ± SD age, 44.1 ± 10.8 years; 78% male; mean ± SD BMI, 28.1 ± 4.3 kg/m2). The elapsed time to surgery was 6.5 ± 4.0 days. At 12-month follow-up, patients had an HRHI of 82% ± 16% and performed 82% ± 17% of repetitions compared with the noninjured side. Participants had a mean ATRS of 87 ± 15 and a median Tegner score of 5 (range, 1-9), with a reduction in Tegner score of 2 from preinjury levels. The relative ATRA at 12 months was –4.8° ± 3.9°. Multiple regression identified younger age (B = ±0.006; P <.001) and greater intraoperative ATRA (B = 0.005; P =.053) as predictors of more symmetrical 12-month HRHI (R 2 = 0.19; P <.001; n = 120). Conclusion: Age was found to be the strongest predictor of outcome after Achilles tendon rupture. The most important modifiable risk factor was the tightness of repair. It is recommended that repair be performed as tight as possible to optimize heel-rise height 1 year after Achilles tendon rupture and possibly to reduce tendon elongation.

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