2022

Treatment with bile acid sequestrants improves quality-of-life in specific patients with bile acid diarrhoea (2022)

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Type of publication:Conference abstract

Author(s):Kumar A.; Galbraith N.; Al-Hassi H.; Jain M.; *Butterworth J.; Steed H.; McLaughlin J.; Brookes M.

Citation:Gut. Conference: Annual Meeting of the British Society of Gastroenterology, BSG 2022. Birmingham United Kingdom. 71(Supplement 1) (pp A156), 2022. Date of Publication: June 2022

Abstract:Background Bile acid diarrhoea (BAD) is a common cause of chronic diarrhoea and up to 30% of patients can be misdiagnosed as irritable bowel syndrome. Type 1 BAD is secondary to ileal resection or inflammation; type 2 is idiopathic; and type 3 is secondary to other intestinal conditions such as cholecystectomy. BAD can be severely debilitating and negatively affect patients' quality of life (QoL). We carried out a multicentre prospective study exploring QoL outcomes in patients with BAD before and after treatment with colesevelam. Methods Patients with or without BAD (defined by a 23- seleno-25-homotaurocholic acid (SeHCAT) retention < 19%) were recruited into four groups: 1) SeHCAT normal control group (CG), 2) idiopathic (BAD), BAD secondary to 3) postcholecystectomy (PC) and 4) post-terminal ileal resection for Crohn's disease (CD). Patients in groups 2-4 were treated with colesevelam and dosing was titrated to symptomatic response. Patients were reviewed at 4- and 8-weekly intervals and QoL evaluated by EQ-5D-3L, SF-36, IBDQ-32 (where relevant). Clinical response was defined as patients who had improved bowel frequency by >50% or <3 bowel movements per day. Results 47 patients (BAD=24, PC=12, CD=11) completed QoL questionnaires before and after treatment and 30 CG patients completed a baseline questionnaire. The CD cohort had improved IBDQ-32 mean scores after treatment (134.6 vs 158.4, p=0.007). The BAD and CD cohort showed improved mean scores with treatment in all components of the SF-36 and EQ-5D-3L, whilst the PC cohort showed a general decline in mean scores after treatment. The CG cohort generally had higher baseline scores than the other three groups. 55% of patients clinically responded to treatment (41.7% BAD, 58.3% PC, 81.8% CD). Correlations between those deemed as responders with improvements on the IBDQ-32, SF-36 and EQ-5D-3L dimensions were not statistically significant. Conclusion Our results demonstrate improved QoL in the BAD and CD cohort with treatment. Further larger studies are recommended specifically investigating the PC cohort and whether patients may improve with newer treatments such as FXR agonists.

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The use of a faecal bile acid test for diagnosing patients with bile acid diarrhoea (2022)

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Type of publication:Conference abstract

Author(s):Kumar A.; Al-Hassi H.; Jain M.; Ford C.; Gama R.; Steed H.; *Butterworth J.; McLaughlin J.; Galbraith N.; Brookes M.; Hughes L.;

Citation:Gut. Conference: Annual Meeting of the British Society of Gastroenterology, BSG 2022. Birmingham United Kingdom. 71(Supplement 1) (pp A157), 2022. Date of Publication: June 2022.

Abstract:Introduction BAD is a common cause of chronic diarrhoea, affecting 1% of the general population. Type 1 is secondary to ileal resection or inflammation; type 2 is idiopathic; and type 3 is a result of other intestinal conditions such as cholecystectomy. Although the UK gold standard diagnostic test for BAD is the 75selenium-homotaurocholic acid (SeHCAT) scan, this is not widely available. This study examines the validity of measuring faecal bile acids (FBA) in a single stool sample as a diagnostic tool for bile acid diarrhoea (BAD) by direct comparison to the SeHCAT. Methods Patients with chronic diarrhoea investigated for BAD with a SeHCAT scan were prospectively recruited to the study. Patients provided random stool samples to measure FBA, using an enzyme-linked immunosorbent assay. Patients were characterised into four groups: SeHCAT negative control group (CG), post-cholecystectomy (PC), idiopathic BAD and post-terminal ileal resection Crohn's disease (CD). SeHCAT retention of <5%, 5-10%, 10-15% and >15% were considered to be severe BAD, moderate, mild and normal, respectively. Results 108 patients had a stool with a comparative SeHCAT result. FBA concentrations (umol/g) and interquartile ranges in patients in CG (2.6; 1.6-4.1), PC (4.0; 2.4-6.6) and BAD (3.6; 1.9-7.2) were similar, but all were significantly lower (p<0.001) compared to patients with CD (12.5; 10.2-16.1). FBA concentrations in patients with SeHCAT retention of <5% (8.6; 4.3-15.4) were significantly higher (p<0.005) than those with a SeHCAT retention >15% (2.6; 1.5-4.2). Using <=15% SeHCAT retention as diagnostic for BAD, the sensitivity and specificity with FBA cut-off of 1.6umol/g were 89% and 26% respectively. Conclusion This pilot study demonstrated that a single random stool sample may have potential use in diagnosing severe BAD or BAD in CD patients. Larger studies are needed to confirm the potential efficacy of a single, random FBA test to accurately diagnose BAD in the absence of SeHCAT testing.

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Quality of life and two-year results of a randomized phase III study of dysphagiaoptimized intensity modulated radiotherapy (DO-IMRT) versus standard IMRT (SIMRT) in head and neck cancer (2022)

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Type of publication:Conference abstract

Author(s):Nutting C.; Rooney K.; Foran B.; *Pettit L.; Beasley M.; Finneran L.; Roe J.; Tyler J.; Roques T.; Cook A.; Petkar I.; Bhide S.; Srinivasan D.; Boon C.; De Winton E.; Frogley R.; Sydenham M.A.; Emson M.; Hall E.

Citation:Journal of Clinical Oncology. Conference: Annual Meeting of the American Society of Clinical Oncology, ASCO 2022. Online. 40(16 Supplement 1) (no pagination), 2022. Date of Publication: June 2022

Abstract:Background: Most newly diagnosed oro- & hypopharngeal cancers (OPC, HPC) are treated with (chemo) RT with curative intent but at the consequence of adverse effects on quality of life. We investigated if using DO-IMRT to reduce RT dose to the dysphagia/aspiration related structures (DARS) improved swallowing function compared to S-IMRT. Method(s): Patients with T1-4, N0-3, M0 OPC/HPC were randomised 1:1 to S-IMRT (65 Gray (Gy)/30 fractions (f) to primary & nodal tumour; 54Gy/30f to remaining pharyngeal subsite & nodal areas at risk of microscopic disease) or DO-IMRT. The volume of the superior & middle pharyngeal constrictor muscle (PCM) (OPC) or inferior PCM (HPC) lying outside the high-dose target volume was set a mandatory mean dose constraint in DO-IMRT. Treatment allocation was by minimisation balanced by centre, use of induction/concomitant chemotherapy, tumour site & AJCC stage. Primary endpoint was mean MD Anderson Dysphagia Inventory (MDADI) composite score 12 months after RT. Secondary endpoints included University of Washington (UW)-Qol, Performance Status Scale Head & Neck (PSS-HN) domain scores (range: 0-100), swallow volume, swallow capacity and local control. Result(s): 112 patients (56 S-IMRT, 56 DO-IMRT) were randomised from 22 UK & Ireland centres from 06/2016 – 04/2018. 111/112 had RT doses as prescribed (1 patient died before RT). Outcome measures at 12 and 24 months are summarised below. DO-IMRT had higher MDADI scores at 12 (p = 0.04) and 24 (p = 0.07) months. Clinically important improvements in swallowing function were seen in patients receiving DO-IMRT using PSS-HN domains and the UW-QoL tool. Conclusion(s): DO-IMRT improved patient reported swallowing function compared with S-IMRT. Improvements were seen in overall MDADI as well as functional scores in both PSS-HN and UW-QoL.

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Implications for sequencing of biologic therapy and choice of second anti-TNF in patients with inflammatory bowel disease: Results from the IMmunogenicity to Second Anti-TNF therapy (IMSAT) therapeutic drug monitoring study (2022)

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Type of publication:Journal article

Author(s):Chanchlani N.; Lin S.; Auth M.K.; Lee C.L.; Robbins H.; Looi S.; Murugesan S.V.; Riley T.; Preston C.; Stephenson S.; Cardozo W.; Sonwalkar S.A.; Allah-Ditta M.; Mansfield L.; Durai D.; Baker M.; London I.; London E.; Gupta S.; Di Mambro A.; Murphy A.; Gaynor E.; Jones K.D.J.; Claridge A.; Sebastian S.; Ramachandran S.; Selinger C.P.; Borg-Bartolo S.P.; Knight P.; Sprakes M.B.; Burton J.; Kane P.; Lupton S.; Fletcher A.; Gaya D.R.; Colbert R.; Seenan J.P.; MacDonald J.; Lynch L.; McLachlan I.; Shields S.; Hansen R.; Gervais L.; Jere M.; Akhtar M.; Black K.; Henderson P.; Russell R.K.; Lees C.W.; Derikx L.A.A.P.; Lockett M.; Betteridge F.; De Silva A.; Hussenbux A.; Beckly J.; Bendall O.; Hart J.W.; Thomas A.; Hamilton B.; Gordon C.; Chee D.; McDonald T.J.; Nice R.; Parkinson M.; Gardner-Thorpe H.; *Butterworth J.R.; *Javed A.; *Al-Shakhshir S.; *Yadagiri R.; *Maher S.; Pollok R.C.G.; Ng T.; Appiahene P.; Donovan F.; Lok J.; Chandy R.; Jagdish R.; Baig D.; Mahmood Z.; Marsh L.; Moss A.; Abdulgader A.; Kitchin A.; Walker G.J.; George B.; Lim Y.-H.; Gulliver J.; Bloom S.; Theaker H.; Carlson S.; Cummings J.R.F.; Livingstone R.; Beale A.; Carter J.O.; Bell A.; Coulter A.; Snook J.; Stone H.; Kennedy N.A.; Goodhand J.R.; Ahmad T.

Citation:Alimentary Pharmacology and Therapeutics, 2022 Oct; Vol. 56 (8), pp. 1250-1263. Date of Publication: October 2022

Abstract:Background: Anti-drug antibodies are associated with treatment failure to anti-TNF agents in patients with inflammatory bowel disease (IBD). <Aim(s): To assess whether immunogenicity to a patient's first anti-TNF agent would be associated with immunogenicity to their second, irrespective of drug sequence. <br/>Method(s): We conducted a UK-wide, multicentre, retrospective cohort study to report rates of immunogenicity and treatment failure of second anti-TNF therapies in 1058 patients with IBD who underwent therapeutic drug monitoring for both infliximab and adalimumab. The primary outcome was immunogenicity to the second anti-TNF drug, defined at any timepoint as an anti-TNF antibody concentration >=9 AU/ml for infliximab and >=6 AU/ml for adalimumab. Result(s): In patients treated with infliximab and then adalimumab, those who developed antibodies to infliximab were more likely to develop antibodies to adalimumab, than patients who did not develop antibodies to infliximab (OR 1.99, 95%CI 1.27-3.20, p = 0.002). Similarly, in patients treated with adalimumab and then infliximab, immunogenicity to adalimumab was associated with subsequent immunogenicity to infliximab (OR 2.63, 95%CI 1.46-4.80, p < 0.001). For each 10-fold increase in anti-infliximab and anti-adalimumab antibody concentration, the odds of subsequently developing antibodies to adalimumab and infliximab increased by 1.73 (95% CI 1.38-2.17, p < 0.001) and 1.99 (95%CI 1.34-2.99, p < 0.001), respectively. Patients who developed immunogenicity with undetectable drug levels to infliximab were more likely to develop immunogenicity with undetectable drug levels to adalimumab (OR 2.37, 95% CI 1.39-4.19, p < 0.001). Commencing an immunomodulator at the time of switching to the second anti-TNF was associated with improved drug persistence in patients with immunogenic, but not pharmacodynamic failure. Conclusion(s): Irrespective of drug sequence, immunogenicity to the first anti-TNF agent was associated with immunogenicity to the second anti-TNF, which was mitigated by the introduction of an immunomodulator in patients with immunogenic, but not pharmacodynamic treatment failure.

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Deposition keratopathy (2022)

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Type of publication:Journal article

Author(s):
Panthagani J.; MacDonald T.; *Bruynseels A.; Madathilethu S.C.; Jenyon T.

Citation:British Journal of Hospital Medicine. 83(7) (pp 1-13), 2022. Date of Publication: 02 Jul 2022.

Abstract:Material can be deposited in the cornea as a result of a wide range of systemic and ophthalmic diseases, as well as local and systemic therapies. Causes include local infection or trauma, systemic malignancy, a wide range of medications and a host of genetic and metabolic diseases. Some of these can be acutely life threatening, so generalists caring for both children and adults should have a basic awareness of the pattern and distribution of corneal deposits to facilitate timely diagnosis, investigation, management or onward referral to avoid significant morbidity or mortality. This article outlines causes of corneal deposits found in patients presenting to primary care, ophthalmic clinics or encountered on the wards to help generalists avoid missing serious pathology. It also provides insight into the natural history of underlying causative conditions and their possible treatments.

PROMPTS RCT of screening MRI for spinal cord compression in prostate cancer (ISRCTN74112318) (2022)

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Type of publication:Conference abstract

Author(s):Dearnaley D.; Hinder V.; Hijab A.; Horan G.; *Srihari N.; Rich P.; Houston G.; Henry A.; Gibbs S.; Venkitaraman R.; Cruickshank C.; Hassan S.; Mason M.; Pedley I.; Payne H.; Brock S.; Wade R.; Robinson A.; Din O.; Lees K.; Murray J.; Parker C.; Griffin C.; Sohaib A.; Hall E.

Citation:Radiotherapy and Oncology. Conference: ESTRO 2022. Copenhagen Denmark. 170(Supplement 1) (pp S78-S80), 2022. Date of Publication: May 2022.

Abstract:Purpose or Objective Early diagnosis of malignant spinal cord compression (SCC) is crucial as pre-treatment neurologic status is the major determinant of outcome. In metastatic castrate resistant prostate cancer (mCRPC) SCC is a significant cause of diseaserelated morbidity. In the PROMPTS trial we investigated whether screening for SCC with spinal MRI, with pre-emptive treatment if radiological SCC (rSCC) was detected, reduced the incidence of clinical SCC (cSCC) in asymptomatic mCRPC patients. Materials and Methods PROMPTS is a phase III parallel-group, randomised controlled superiority trial. CRPC patients aged at least 18 years with spinal metastases without related back pain or neurological symptoms, no previous SCC, and no spinal MRI in previous 12 months were eligible. Participants were randomly allocated (1:1 ratio) to control (no MRI) or screening spinal MRI. Allocation was not masked. A validated epidural spinal cord compromise scale (ESCC) was used. Pre-emptive treatment and 6-monthly spinal MRI were offered to patients with screen-detected rSCC. The primary endpoint was incidence of cSCC at 12 months. Results Between Feb 26, 2013 and April 25, 2017, we randomly assigned 420 men from 45 UK centres to control (n=210) or screening MRI (n=210). Median age was 74 years (IQR:68-79), 53% (222/420) had normal alkaline phosphatase and median PSA was 48.0ng/ml (IQR:17-162). rSCC was detected at screening in 61/200 (30.5%) intervention group patients. Concordance of local and central assessments of rSCC was good (92.4%). At 12 months, the cumulative incidence of cSCC was 6.7% (95% CI 3.8-10.6) in the control group and 4.3% (2.1-7.7) in the intervention group (Gray's test p=0.119, HR:0.64 95%CI:0.37-1.11, Fig 1). In the intervention group cSCC developed more commonly in the rSCC +ve cases (11.5%) than the rSCC -ve cases (1.3%) and the rSCC-ve group had significantly less cSCC than the control group (Gray's test p=0.04, Fig2). Intervention for rSCC was with radiotherapy (RT) in 50/61 (82%) cases, only 4% progressed at the treated sites. RT was not given to 18 sites with early rSCC (ESCC 1a-b,17: 1c, 1) but none progressed at 6 months. At the time of cSCC 70% of patients were ambulant and 18% of non-ambulant patients regained function post-RT. More spinal RT was given in the intervention than control group (86vs49 courses) but the use of additional systemic therapy was significantly less by 12 months (54%vs70%, Gray's test p=0.003). Conclusion We found no statistically significant differences in incidence of cSCC between the intervention and control groups. MRI screen-detected early rSCC lesions do not always progress to cSCC with contemporary systemic management of CRPC and observation may be reasonable for ESCC grade 1a/b lesions. However these patients remain at substantial risk of developing new sites of cSCC. Further efforts to better identify patients at high risk for rSCC and cSCC are warranted to refine selection of groups for screening spinal MR.

Crucial, complex, caring: a new professional development framework for Lung Cancer Nurse Specialists (2022)

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Type of publication:Conference abstract

Author(s):Roberts J.; Barton P.; Clayton K.; Fenemore J.; Ivey S.; *McAdam J.; Shepherd P.

Citation:Lung Cancer. Conference: 20th Annual British Thoracic Oncology Group Conference 2022. Virtual, Online. 165(Supplement 1) (pp S40), 2022. Date of Publication: March 2022.

Abstract:Introduction: Lung cancer specialist nursing is a varied, valuable and rewarding career, and the need for lung cancer nurse specialists (LCNS) is increasing. Lung Cancer Nursing UK (LCNUK) wants to encourage nurses to aspire to becoming an LCNS, and to support those already working in lung cancer teams to flourish professionally. We want employers to recognise LCNS' capabilities and to recruit and reward them accordingly. LCNUK therefore set out to draft the first professional development framework for LCNS. The Framework is intended to guide nurses, line managers and employers on the core skills, knowledge and expertise that LCNS will gain and demonstrate as they progress in role. Method(s): LCNUK convened a working group which reviewed exemplars and supporting literature. The team produced a draft framework setting out the qualifications, skills and capabilities needed by nurses operating at different levels, aligned with the (Figure Presented) four pillars of advanced practice. Feedback on the draft was sought from expert stakeholders before the final document was approved by the LCNUK Steering Committee. The Framework was developed in a collaboration between LCNUK and MSD, who funded a policy consultancy to provide secretariat support. LCNUK retained editorial independence of the framework content. Result(s): The Framework sets out the qualifications, clinical skills, knowledge, leadership and management and research capabilities that LCNUK expects aspiring and existing LCNS to demonstrate or be working towards. It includes case studies of nurses' career journeys and an example of a successful case for job matching and re-banding. The Framework is available on the LCNUK website at www.lcnuk.org. Conclusion(s): The Framework asserts the crucial role of LCNS in managing safety-critical and complex patient care and in leading service delivery and improvement. We hope it will prove a valuable tool to nurses, employers and policymakers in understanding the complexity and importance of this essential role.

CT coronary angiography significantly changes treatment targets versus coronary artery calcium scoring in high-risk dyslipidaemia patients (2022)

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Type of publication:Conference abstract

Author(s):Graby J.; Sellek J.; Bayly G.; Avades T.; *Capps N.; Shipman K.; Mbagaya W.; Luvai A.; Khavandi A.; Loughborough W.; Hudson B.; Downie P.; Rodrigues J.;

Citation:Heart. Conference: British Cardiovascular Society Annual Conference, BCS 2022. Manchester United Kingdom. 108(Supplement 1) (pp A135-A136), 2022. Date of Publication: June 2022.

Abstract:Introduction Dyslipidaemia accelerates atherosclerosis. Patients with genetic dyslipidaemias, Familial Hypercholesterolaemia (FH) being the most common, are at heightened risk of premature cardiovascular events. However, this risk is heterogeneous within identical genotype diseases, and modifiable with treatment. Coronary imaging identifies subclinical atherosclerosis, personalises risk stratification and treatment targets. Coronary artery calcium scoring (CACS) is first-line for primary prevention. However, calcification is a late-stage process in CAD pathogenesis and the CACS has low specificity in young patients with severe FH. CT coronary angiography (CTCA) may identify non-calcific CAD and high risk plaque (HRP) features unseen with CACS. This study aimed to quantify the impact of CTCA vs traditional CACS on clinical management in real-world asymptomatic Lipid Clinic patients. Methods A retrospective single-centre review of asymptomatic Lipid Clinic electronic patient records with both CACS and CTCA from May 2019 to December 2020. A vignette was compiled for each patient providing all relevant clinical data. CACS was recorded as Agastston score and CTCA as the Coronary Artery Disease – Reporting and Data System (CAD RADS) grading of anatomical stenosis with a modifier for HRP features.Findings were compiled into an anonymised online survey which Consultant Biochemists from across the UK were invited to complete. Data was revealed in a stepwise fashion to the participating clinician: (i) vignette only, (ii) CACS, and (iii) CAD RADS. Clinicians were asked their lipid target and management after each data-point was unblinded. Background information on CACS and CTCA result interpretation was provided prior to participation. Statistical analysis was performed using SPSS v.21 and significance was defined as two-tailed p<0.05. Results 45 asymptomatic patients (55+/-9 years, 49% female) were included. 7 Consultant Biochemists from 6 institutions (4 [67%] tertiary/teaching Hospitals and 2 [33%] district general Hospitals) participated.CACS and CAD RADS assessment of disease burden is presented in Figure 1, with CTCA re-classifying CAD severity vs CACS in 28/45 (62%) patientsLipid targets were altered significantly more frequently with CTCA vs CACS (19% vs 12%; chi2 57.0, p<0.005), even after CACS result available (Figure 2). The LDL target selected was altered by CACS in 12%, and in a further 19% when CAD RADS result was unblinded, which was statistically significant (c2 57.0, p<0.005). This finding was consistent across FH and non-FH patients. Increasing CACS and CAD RADS severity were significantly associated with change in lipid target (c2 54.2, p<0.001; chi2 27, p<0.001), the latter even after a high CACS result was available, as did presence of HRP (chi2 9.3, p=0.002). Conclusion In high-risk asymptomatic dyslipidaemia, CTCA alters treatment targets beyond CACS by demonstrating higher CAD severity burden and HRP. This may differentiate high risk and very high risk patients in an important population.

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A multi-dimensional approach towards implementing the effective use of remote electrocardiographic monitoring - evaluation of clinical correlation and patient experience (2022)

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Type of publication:Conference abstract

Author(s):*Asad M.; Younas W.; *Kazi S.I.; Alaguraja P.; *Makan J.

Citation:Heart. Conference: British Cardiovascular Society Annual Conference, BCS 2022. Manchester United Kingdom. 108(Supplement 1) (pp A74-A75), 2022. Date of Publication: June 2022.

Abstract:Background Inappropriate use of telemetry results in the overuse of limited resources, disrupted provider workflow, higher costs of care, and false alarms with resultant alarm fatigue. Moreover, identifying a useful implementation blueprint is an important component of promoting its appropriate use. Telemetry can influence patient experience during their stay as potentially it can disturb sleep, contribute to delirium, and increase patient frustration and anxiety. We stipulate that even minor adjustments to monitoring practices can influence optimised patient care. We aimed to evaluate the co-existing standards of practice regarding use of telemetry across Shrewsbury and Telford Hospital NHS Trust (SaTH). We implemented a patient-centred approach towards quality improvement by incorporating record of patient experience as a tool to guide effective use of this limited resource across our district general hospital settings. Methods Patients across two hospital sites were selected to conduct a prospective health service evaluation related to the use of telemetry. A likert scale survey was conducted to record patient perspective of telemetry monitoring including a section with an opportunity to provide feedback towards service improvement. The data of patients receiving telemetry was collected from December 2021 to February 2022.American Heart Association (AHA) consensus statement for remote electrocardiographic monitoring was utilized to evaluate the proposed indication for telemetry. However, the rating system helped group patients receiving telemetry monitoring as Class I (definitely indicated), Class II (maybe indicated), or Class III (not indicated). Clinical notes and electronic telemetry system was employed to record parameters including patient demographics; presenting complaint; class (I-III) of indication; whether an indication for telemetry was documented; the length of telemetry; and the details of any significant events that occurred during monitoring including escalation. Where possible, patients were asked to anonymously provide feedback via set questionnaire focusing on quality of care received by the patient. Result(s):Among the 30 patients who were included in our analysis, 7 were females and the average age in our cohort was found to be 72.8. In about 56% of the patients, there was no clear indication mentioned in the clinical notes regarding continuation/discontinuation of telemetry. Based on proposed indication, about 36.66% (11 patients out of which 2 were female) were identified to be at significant risk of an immediate life-threatening arrhythmia (Class I). Among this group, 2 patients were reported to have significant arrhythmia event necessitating treatment. Further analysis revealed that from our cohort, 46.66% (14 patients) had a Class II indication for their telemetry monitoring out of which only 2 patients had a significant event recorded. However, only 16.66% (5 patients) were found to meet the eligibility for Class III indications and none of them encountered a significant arrhythmia. From anonymously filled patient questionnaires, around two-third of the patients reported not being informed about the utility of telemetry and its predicted duration of stay. One-third of patients reported the device to be inconvenient, intrusive and heavy. Conclusions To accomplish a sustainable improvement, a patient-centred approach should be exercised to help identify the gaps in quality of care delivered. Our analysis showed that significant number of patients received telemetry when it was not clinically indicated. The proposed interventions include adopting formal request process for telemetry, predicting its duration, use of patient education tools and exploring compatibility of telemetry device used. Larger scale studies are required to gain more insight into the appropriateness and impact of telemetry in a hospital setting.

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Antibody decay, T cell immunity and breakthrough infections following two SARS-CoV-2 vaccine doses in inflammatory bowel disease patients treated with infliximab and vedolizumab (2022)

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Type of publication:Journal article

Author(s):Lin S.; Kennedy N.A.; Saifuddin A.; Sandoval D.M.; Reynolds C.J.; Seoane R.C.; Kottoor S.H.; Pieper F.P.; Lin K.-M.; Butler D.K.; Chanchlani N.; Nice R.; Chee D.; Bewshea C.; Janjua M.; McDonald T.J.; Sebastian S.; Alexander J.L.; Constable L.; Lee J.C.; Murray C.D.; Hart A.L.; Irving P.M.; Jones G.-R.; Lees C.W.; Altmann D.M.; Boyton R.J.; Goodhand J.R.; Powell N.; Kok K.B.; Bokth F.; Cipriano B.; Francia C.; Khalid N.; Khatun H.; Kingston A.; Lee I.; Lehmann A.; Naik K.; Pabriaga E.; Plaatjies N.; Samuels K.; Saich R.; Cousins H.; Thomas R.; Brown M.; White B.; Tilley B.; Muhammed R.; Bi R.; Cotter C.; Grove J.; Hong K.; Howman R.; Clayton S.; Sultan S.; Rooney M.; Cottrill C.; Singh S.; Dawe C.; Hull R.; Silva N.; Manning J.; Finlayson L.; Roebuck A.; Dawson J.; Sonwalkar S.; Chambers N.; Robinson M.; Haigh A.; Matapure L.; Raine T.; Kapizioni C.; Strongili K.; Thompson T.; Ahmed M.; Kontos C.; Bourges C.; Barbutti I.; Gozzard M.E.; Hendy P.; Bull R.; Costa P.; Davey L.; Hannington H.; Nundlall K.; Martins C.; Avanzi L.; Carungcong J.; Barr S.; Appleby R.; Johnson E.; Phillis K.; Gascoyne R.; Crowder A.; Whileman A.; London I.; Grounds J.; Martin E.; Price J.; Cawley K.; Dhar A.; Brown E.; Cowton A.; Warner B.; Stuart C.; Lacey L.; de Silva S.; Allcock C.; Harvey P.; Jones L.; Cooke E.; Brooks J.; Baker P.; Beadle H.; Cruz C.; Potter D.; Collum J.; Masters F.; Kumar A.; Coetzee S.; Peiu M.; Icke B.; Raj M.; Gaynor E.; Chadokufa S.; Huggett B.; Meghari H.; El-Khouly S.; Kiparissi F.; Girshab W.; Claridge A.; Fowler E.; McCafferty L.; Christodoulides K.; Clifford A.; Dawson P.; Honap S.; Lim S.; Luber R.; Mahiouz K.; Meade S.; Reynolds R.; Stanton A.; Tripoli S.; Hare N.; Balachandran S.; North E.; North J.; Browne B.; Jameson E.; Siaw Y.H.; Manzano L.; Segal J.; Al-Bakir I.; Khakoo I.; Thoua N.; Davidson K.; Miah J.; Canclini L.; Hall A.; Hayes M.; Myers S.; Talbot A.; Turnbull J.; Whitehead E.; Stamp K.; Pattinson A.; Mathew V.; Sherris L.; Harvey A.; Hicks L.; Byrne T.-M.; Cabreros L.; Downing-Wood H.; Hunter S.; Prabhudev H.; Balarajah S.; Ibraheim H.; Torkizadeh M.; Lo J.W.; Liu Z.; Sutherland H.; Wilhelmsen E.; Mackintosh K.; Verma A.M.; Sebastian J.; Peerally M.F.; Raymode P.; Guerdette A.-M.; Kent A.; Choong L.M.; Pantaloni B.; Ravdas P.; Vadamalayan B.; Foley S.; Arnold B.; Heeley C.; Lovegrove W.; Sowton D.; Allsop L.; Gregory H.; Smith P.J.; Bretland G.; King S.; Lofthouse M.; Rigby L.; Subramanian S.; Tyrer D.; Martin K.; Probert C.; Kamperidis N.; Adedoyin T.; Baden M.; Chacko F.; Cicchetti M.; Saifuddin M.A.; Yesupatham P.; Gowda R.; Williams M.; Kemp K.; Akhand R.; Gray G.; John A.; John M.; Mohammed T.; Sathe D.; Jones N.; Soren J.; Sprakes M.; Burton J.; Kane P.; Lupton S.; Bartholomew J.; MacFaul G.; Scaletta D.; Siamia L.; Williams F.; Green C.; Ver Z.; Lamb C.A.; Doona M.; Hogg A.; Jeffrey L.; King A.; Speight R.A.; Doyle J.; Owen R.; Mowat C.; Rice D.; MacFarlane S.; MacLeod A.; Mohammed S.; Murray S.; Elliott A.; Morris M.A.; Coke L.; Hindle G.; Kolokouri E.; Wright C.; Lee C.; Ward N.; Dann A.; Lockett M.; Cranfield C.; Jennings L.; Srivastava A.; Ward L.; Jeynes N.; Ranga P.; Rajasekhar P.; Gallagher L.; Patterson L.; Ward J.; Basnett R.; Murphy J.; Parking L.; Lawson E.; Short S.; Devadason D.; Moran G.; Khan N.; Tarr L.; Olivia C.; Limdi J.; Goulden K.; Javed A.; McKenzie L.; Bhandari P.; Baker-Moffatt M.; Dash J.; Le Poidevin A.; Downe H.; Bombeo L.; Blackman H.; Wiles A.; Bloxham H.; Dias J.; Nadar E.; Curgenven H.; Macdonald J.; Finan S.; McMeeken F.; Mahmood M.; Shields S.; Seenan J.P.; DeSilva D.; Malkakorpi S.; Carson R.; Whiteoak S.; Edger-Earley K.; Vamplew L.; Ingram S.; Botfield S.; Hammonds F.; James C.; Ahmad T.; Aspinall G.; Hawkins S.; Marriott S.; Redstone C.; Windak H.; Adam A.-M.; Mabb H.; Murray C.; Diaba C.; Joseph F.; Pakou G.; Gleeson Y.; Berrill J.; Stroud N.; Pothecary C.; Roche L.; Turner K.; Deering L.; Israel L.; Baker E.; Cutler S.; Evans R.M.; Nash M.; Mallison G.; Roynon A.; Gordon J.; 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Citation:Nature Communications. 13(1) (no pagination), 2022. Article Number: 1379. Date of Publication: December 2022 [epub ahead of print]

Abstract:Anti tumour necrosis factor (anti-TNF) drugs increase the risk of serious respiratory infection and impair protective immunity following pneumococcal and influenza vaccination. Here we report SARS-CoV-2 vaccine-induced immune responses and breakthrough infections in patients with inflammatory bowel disease, who are treated either with the anti-TNF antibody, infliximab, or with vedolizumab targeting a gut-specific anti-integrin that does not impair systemic immunity. Geometric mean [SD] anti-S RBD antibody concentrations are lower and half-lives shorter in patients treated with infliximab than vedolizumab, following two doses of BNT162b2 (566.7 U/mL [6.2] vs 4555.3 U/mL [5.4], p <0.0001; 26.8 days [95% CI 26.2 – 27.5] vs 47.6 days [45.5 – 49.8], p <0.0001); similar results are also observed with ChAdOx1 nCoV-19 vaccination (184.7 U/mL [5.0] vs 784.0 U/mL [3.5], p <0.0001; 35.9 days [34.9 – 36.8] vs 58.0 days [55.0 – 61.3], p value < 0.0001). One fifth of patients fail to mount a T cell response in both treatment groups. Breakthrough SARS-CoV-2 infections are more frequent (5.8% (201/3441) vs 3.9% (66/1682), p = 0.0039) in patients treated with infliximab than vedolizumab, and the risk of breakthrough SARS-CoV-2 infection is predicted by peak anti-S RBD antibody concentration after two vaccine doses. Irrespective of the treatments, higher, more sustained antibody levels are observed in patients with a history of SARS-CoV-2 infection prior to vaccination. Our results thus suggest that adapted vaccination schedules may be required to induce immunity in at-risk, anti-TNF-treated patients.

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