Staff Publication

Folic Acid Supplementation in Postmenopausal Women with Hot Flushes: Phase III Randomised Double-Blind Placebo-Controlled Trial (2021)

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Type of publication:
Randomised controlled trial

Author(s):
Ayman Ewies, Ikhlaq Ahmed, Farook Alazzawi, Joan Pitkin, Pratima Gupta, Mojca Persic, *Banchhita Sahu, Alaa El-Ghobashy, Lisa Barraclough, Jacqueline Woodman, Jaspreet Babrah, Sarah Bowdem, Deborah Stocken, Lucinda Billingham, Sudha Sundar, Daniel Rea

Citation:
BJOG; November 2021; Volume128, Issue12, Pages 2024-2033

Abstract:
Objective: To assess whether folic acid supplementation ameliorates hot flushes. Design: Double-blind, placebo-controlled randomised trial. Setting: Nine hospitals in England. Population: Postmenopausal women experiencing ≥50 hot flushes weekly. Methods: Women (n=164) were randomly assigned in a 1:1 ratio to receive folic acid 5mg tablet or placebo daily for 12 weeks. Participants recorded frequency and severity of hot flushes in Sloan Diary daily and completed Greene Climacteric and Utian Quality of Life (UQoL) Scales at 4-weekly intervals. Main Outcome Measures: The change in daily Hot Flush Score at week-12 from randomisation based on Sloan Diary Composite Score B calculation. Results: Data of 143 (87%) women was available for the primary outcome. The mean change (SD) in Hot Flush Score at week-12 was -6.98 (10.30) and -4.57 (9.46) for folic acid and placebo group, respectively. The difference between groups in the mean change was -2.41 (95% CI: -5.68, 0.87), p=0.149 and in the adjusted mean change was -2.61 (95% CI: -5.72, 0.49) with p=0.098. There was an increased benefit in the folic acid group regarding changes in total and emotional UQoL scores at week-8 when compared with placebo. The difference in the mean change from baseline was 5.22 (95% CI: 1.16, 9.28) and 1.88 (95% CI: 0.23, 3.52) for total and emotional score, respectively. Conclusions: Folic acid had a greater benefit in reducing Hot Flush Score over 12 weeks in postmenopausal women when compared with placebo; however, the difference did not reach statistical significance. Definitive evidence of benefit requires a larger study.

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Statins as Potential Chemoprevention or Therapeutic Agents in Cancer: a Model for Evaluating Repurposed Drugs (2021)

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Type of publication:
Journal article

Author(s):
Joharatnam-Hogan N, Alexandre L, Yarmolinsky J, *Lake B, *Capps N, Martin RM, Ring A, Cafferty F, Langley RE

Citation:
Current Oncology Reports, 13 Feb 2021, 23(3):29

Abstract:
Purpose of review: Repurposing established medicines for a new therapeutic indication potentially has important global and societal impact. The high costs and slow pace of new drug development have increased interest in more cost-effective repurposed drugs, particularly in the cancer arena. The conventional drug development pathway and evidence framework are not designed for drug repurposing and there is currently no consensus on establishing the evidence base before embarking on a large, resource intensive, potential practice changing phase III randomised controlled trial (RCT). Numerous observational studies have suggested a potential role for statins as a repurposed drug for cancer chemoprevention and therapy, and we review the strength of the cumulative evidence here.
Recent findings: In the setting of cancer, a potential repurposed drug, like statins, typically goes through a cyclical history, with initial use for several years in another disease setting, prior to epidemiological research identifying a possible chemo-protective effect. However, further information is required, including review of RCT data in the initial disease setting with exploration of cancer outcomes. Additionally, more contemporary methods should be considered, such as Mendelian randomization and pharmaco-epidemiological research with "target" trial design emulation using electronic health records. Pre-clinical and traditional observational data potentially support the role of statins in the treatment of cancer; however, randomised trial evidence is not supportive. Evaluation of contemporary methods provides little added support for the use of statin therapy in cancer. We provide complementary evidence of alternative study designs to enable a robust critical appraisal from a number of sources of the go/no-go decision for a prospective phase III RCT of statins in the treatment of cancer.

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Rothia mucilaginosa: a case of septic arthritis in a native knee and review of the literature (2021)

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Type of publication:
Journal article

Author(s):
*Daoub, Ahmed; *Ansari, Hamza; *Orfanos, George; *Barnett, Andrew

Citation:
BMJ case reports; Jan 2021; vol. 14 (no. 1)

Abstract:
Rothia mucilaginosa is a Gram-positive aerobic coccus usually found in the oral and respiratory tract. Septic arthritis is an uncommon condition, but is an orthopaedic emergency. A rare case of knee septic arthritis due to R. mucilaginosa is presented. Patient management and outcomes are discussed, and learning points from this case are outlined to help manage any further cases that may arise.

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Do the heel-rise test and isometric strength improve after Achilles tendon repair using Dresden technique? (2022)

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Type of publication:
Journal article

Author(s):
De la Fuente, Carlos; Henriquez, Hugo; *Carmont, Michael R; Huincahue, Javiera; Paredes, Tamara; Tapia, María; Araya, Juan Pablo; Díaz, Nicolás; Carpes, Felipe P

Citation:
Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons; Jan 2022, 28(1) pages 37-43

Abstract:
BACKGROUND Achilles' tendon ruptures result in impaired plantar flexion strength and endurance. It is interesting to know the plantar flexion strength, the number of heel-rise repetitions, and the maximal calf circumference following Achilles' tendon ruptures repair. METHODS Both the injured and non-injured legs of thirty male patients with Achilles' tendon ruptures treated with the percutaneous Dresden technique were compared with the ankle function of 30 healthy participants. Rehabilitation involved partial weight-bearing for three weeks and then increased to full weight-bearing and ankle exercises. RESULTS The injured legs had weaker plantar flexion strength (1.64 ± 0.17 Nm/kg) compared with the non-injured legs (1.91 ± 0.24 Nm/kg; p = 0.002) and the healthy participants' legs (1.93 ± 0.32 Nm/kg; p < 0.001). The non-injured leg had greater ability in doing heel-rise repetitions (39.4 ± 6.1 rep.) compared with the injured legs (37.2 ± 5.7 rep.; p < 0.023) and the healthy participants' legs (31.0 ± 13.0 rep.; p < 0.001). CONCLUSIONS The injured leg had not recovered full isometric strength but had improved heel-rise repetition.

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No difference in Achilles Tendon Resting Angle, Patient-reported outcome or Heel-rise height Index between Non- and Early-weightbearing the First Year after an Achilles Tendon Rupture (2020)

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Type of publication:
Journal article

Author(s):
*Carmont M; Brorsson, A.; Karlsson, J.; Nilsson-Helander, K.

Citation:
Muscles, Ligaments & Tendons Journal (MLTJ); Oct 2020; vol. 10 (no. 4); p. 651-658

Abstract:
Background. Patient-reported outcome scores and comparable re-rupture rates in randomized controlled trials have not shown a definitive benefit for operative treatment after acute Achilles tendon rupture. This, together with the increasing rupture rates in the older age group has led to non-operative treatment being increasingly used. Objective. This study aimed to determine the variation in Achilles Tendon Resting Angle (ATRA) together with patient reported and functional outcome, with non-operative management of the ruptured Achilles tendon using two different regimes, which have been shown to offer low re-rupture rates. Methods. This is a non-randomised cohort comparison of Achilles tendon rupture patients managed with Non-Weight-Bearing (NWB) for 6 weeks vs. Early Weight-Bearing (EWB). The NWB-group received a cast in plantar flexion for 2 weeks followed by 6 weeks in a controlled ankle motion boot with incremental diminishing plantar flexion. The EWB-group received an initial anterior protective plaster slab in plantar flexion followed by 6 weeks of weight-bearing on the meta-tarsal heads, with an anterior shell restricting dorsiflexion. Results. At 12 months after the injury there were no differences in any of the variables between the two treatment groups. The NWB-group compared to the EWB-group reported at mean (SD) for ATRA -9.8° (4.6°) versus -11.4° (5°), p=0.32, for Achilles tendon Total Rupture Score (ATRS) 87 (10) versus 79 (19), p=0.43 and for Heel-Rise Height Index (HRHI) 71% (19%) versus 59% (13%), p=0.13. Conclusions. The two methods of non-operative treatment studied lead to increased relative ATRA following injury, however, patients report only minor limitation in terms of outcome. Patients had almost a third less heel-rise height compared with the non-injured ankle.

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Improving survivorship: A novel partnership between a large colorectal unit and the charity Bowel Cancer UK (2020)

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Type of publication:
Conference abstract

Author(s):
*Hamilton E.; *Lloyd A.; *Cheetham M.; Wix S.; Stone R.

Citation:
Colorectal Disease; Jul 2020; vol. 22 ; p. 54

Abstract:
Background: Bowel Cancer UK and the NHS both have a focus on developing personalised care packages for patients with bowel cancer. Optimising digital information available and signposting patients to resources or events, both locally and nationally can help living well, with and beyond cancer . Method(s): A partnership was initiated between a large district general hospital and Bowel Cancer UK, to refer patients to the charity during clinical appointments, aided by leaflets and information provided on clinical letters. 'Active signposting' commenced September 2019 and will run until April 2020. A cohort of patients has completed a survey to identify uptake, aiding planning of future services. Result(s): 136 new patients were signposted to the charity to date. 70% of patients identified that they had been given information about the website from the hospital, but only 29% subsequently visited the website. 40% of patients stated that a referral letter from the hospital would make them more likely to use the website; patients did not request or identify any other new services that they would find useful. The next phase will involve signposting patients three months after diagnosis. Conclusion(s): This partnership will form part of the personalised care package for patients and is a model that other trusts could consider. Feedback received will help shape future resources and events made available to patients, and help develop a template for NHS Trusts working in partnership with Bowel Cancer UK.

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The correlation between bowel complications and cardiac surgery (2021)

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Type of publication:
Journal article

Author(s):
Mishra V.; Hewage S.; *Islam S.; Harky A.

Citation:
Scandinavian Journal of Surgery; Jun 2021; vol. 110 (no. 2); p. 187-192

Abstract:
Although advances in knowledge and technology have improved outcomes in surgical cardiac patients over the last decade, complications following cardiac operations still remain to be potentially fatal. Gastrointestinal complications, in particular, tend to have high rates of reintervention and mortality following cardiac surgery, with ischemia and hemorrhage being two of the commonest underlying causes. The intention of this review is to identify which risk factors play important roles in predisposing patients to such complications and to gain better insight into the pathogenesis of the sequelae. Furthermore, strategies for prevention have been discussed to educate and increase awareness of how adverse cardiac surgical outcomes can be minimized.

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Using clinical guidelines to assess the potential value of laboratory medicine in clinical decision-making (2021)

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Type of publication:
Journal article

Author(s):
Hicks A.J.; Carwardine Z.L.; *Hallworth M.J.; Kilpatrick E.S.

Citation:
Biochemia Medica; Feb 2021; vol. 31 (no. 1); p. 10703

Abstract:
Introduction: It is often quoted that 70% of clinical decisions are based on laboratory results, but the evidence to substantiate this claim is lacking. Since clinical guidelines aim to document best-practice decision making for specific disease conditions, inclusion of any laboratory test means that the best available evidence is recommending clinicians use it. Cardiovascular disease (CVD) is the world's most common cause of mortality, so this study reviewed all CVD guidelines published by five national/international authorities to determine what proportion of them recommended laboratory testing. Material(s) and Method(s): Five leading CVD guidelines were examined, namely the European Society of Cardiology (ESC), the UK National Institute for Health and Clinical Excellence (NICE), the American College of Cardiology (ACC), the Australian Heart Foundation (AHF) and the Cardiac Society of Australia and New Zealand (CSANZ). Result(s): A total of 101 guidelines were reviewed. Of the 33 individual ESC guidelines relating to CVD, 24/33 made a direct reference to the use of clinical laboratory tests in either diagnosis or follow-up treatment. The same applied to 15/20 of NICE guidelines, 24/32 from the ACC and 15/16 from the AHF/CSANZ. Renal function and blood count testing were the most recommended (39 and 26 times), with lipid, troponin and natriuretic peptide measurement advocated 25, 19 and 19 times respectively. Conclusion(s): This study has shown that laboratory testing is advocated by between 73% and 94% of individual CVD guideline recommendations from five national/international authorities. This provides an index to assess the potential value of laboratory medicine to healthcare.

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A Complex Case of Adalimumab Induced Pleuropericarditis in a Patient with Underlying Ulcerative Colitis (2021)

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Type of publication:
Journal article

Author(s):
*Abbasi A, *Day S, Subahani M, *Townson G

Citation:
Asploro Journal of Biomedical and Clinical Case Reports, 2021 Jan; 4(1) p.16-21

Abstract:
Introduction: Adalimumab is an anti-tumour necrosis factor (anti-TNF) monoclonal antibody and an important part of the treatment regime for autoimmune conditions including inflammatory bowel disease. We present a case of adalimumab induced pleuropericarditis and discuss the diagnosis challenges we faced.
Case History: A 22-year-old male presented to the emergency department with 3 days history of headache, malaise, fever and right-sided chest pain. He was diagnosed with ulcerative colitis 8 months ago but failed to respond to mesalazine, requiring high dose steroids to induce disease remission. His mesalazine was stopped after 4 months and he was initiated on adalimumab 2 months prior to the current presentation. At presentation, he had a temperature of 38.7 °C (101.6 °F) but no other physical signs. His inflammatory markers were raised, and the chest x-ray was clear. He was started on empirical intravenous antibiotics on suspicion of the underlying infective process. On day 4 the patient developed a new pleural rub and crepitations on both lung bases. An urgent echocardiogram and computed tomography scan of the thorax abdomen and pelvis revealed pleural effusion and a 1.8 cm diameter pericardial effusion. Extensive investigation including virology screen, autoimmune screen and pleural fluid analysis were normal.
Diagnosis, Management and Outcome: This case was discussed in a multidisciplinary meeting. A diagnosis of pleuropericarditis secondary to adalimumab was made. Adalimumab and antibiotics were stopped, and he was started on a course of oral steroids. The patient responded well to the treatment and his symptoms resolved.
Conclusion: Rare drug toxicity should be part of differential diagnosis, especially in young patients with unusual presentation. An early multidisciplinary approach is crucial for a positive outcome. The patient should be actively involved in decision making to improve long term outcome.

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Short statured primigravidae: Options for the obstetric management from a survey of UK obstetricians (2021)

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Type of publication:
Journal article

Author(s):
*Rachaneni S.; Gurol-Urganci I.; Basu M.; Thakar R.; Sultan A.; Freeman R.

Citation:
European Journal of Obstetrics Gynecology and Reproductive Biology; Jan 2021; vol. 256 ; p. 379-384

Abstract:
Objective: To assess the current antenatal and intrapartum management options for primigravid women of short stature with a clinically large fetus by a survey of UK Obstetricians. Study design: An online survey comprised of 15 questions including the options on timing and mode of delivery, counselling about the risk of long-term pelvic floor morbidity following spontaneous vaginal and instrumental deliveries, choice of instruments and the role of episiotomy. The survey was sent to the participants as a part of Royal College of Obstetricians and Gynaecologists (RCOG) Newsletter between September 2017 to October 2018. The scenario described was of a primigravid short stature woman (i.e. height of 160 cm or less) who presents with a clinically large fetus at 38 weeks gestation. Result(s): 424 Obstetricians participated in the survey. The participation ratio cannot be identified as the survey was emailed as a part of the RCOG Newsletter. Sixty five percent respondents stated that they would scan for estimated fetal weight, 48 % would offer induction of labour at 40 weeks and 14 % would offer an elective/planned caesarean section (CS) at 39-40 weeks. Fifty nine percent would discuss all these risks: obstructed labour, shoulder dystocia, instrumental delivery and obstetric anal sphincter injury (OASI). 73 % would not discuss the long-term risks of urinary and/or faecal incontinence and pelvic organ prolapse. In the presence of failure to progress in the second stage of labour, 69 % would attempt a rotational instrumental delivery and 5% would offer a caesarean section. Manual rotation and 'straight' forceps application were the most frequent type of rotational delivery, followed by Ventouse and Kiellands forceps. Thirty four percent stated that they do not routinely perform an episiotomy in this scenario. Seventy three percent stated that their choice of instrument was not based on the long-term risk of urinary and faecal incontinence. Conclusion(s): The results suggest that 40 % of the respondents would not discuss all of the complications after vaginal delivery in women of short stature. The most common delivery option would be vaginal delivery.