National Institute For Health And Care Excellence Research Articles

New evidence calls into question NICE's endocarditis prevention guidance

In 2008, National Institute for Health and Care Excellence (NICE) guidelines recommended against the use of antibiotic prophylaxis (AP) before invasive dental procedures (IDPs) to prevent infective endocarditis (IE). They did so because of lack of AP efficacy evidence and adverse reaction concerns. Consequently, NICE concluded AP was not cost-effective and should not be recommended. In 2015, NICE reviewed its guidance and continued to recommend against AP. However, it subsequently changed its wording to ‘antibiotic prophylaxis against infective endocarditis is not routinely recommended'. The lack of explanation of what constituted routinely (and not routinely), or how to manage non-routine patients, caused enormous confusion and NICE remained out of step with all major international guideline committees who continued to recommend AP for those at high risk.Since the 2015 guideline review, new data have confirmed an association between IDPs and subsequent IE and demonstrated AP efficacy in reducing IE risk following IDPs in high-risk patients. New evidence also shows that in high-risk patients, the IE risk following IDPs substantially exceeds any adverse reaction risk, and that AP is therefore highly cost-effective. Given the new evidence, a NICE guideline review would seem appropriate so that UK high-risk patients can receive the same protection afforded high-risk patients in the rest of the world.

Review of patients with diagnosis of abdominal aortic aneurysm (AAA) currently on statin prophylaxis in Scartho Lynton Chantry (SLC) Medical Group, Grimsby

Background: An abdominal aortic aneurysm occurs when a lower part ofthe body’s main artery, called the aorta, becomes weakened and bulges.Most aneurysms do not cause any problems, but can pose serious risk ifthey rupture. Hence, one of the prominent ways to reduce the risk ofrupture is by managing cardiovascular risks using statins as per NationalInstitute for Health and Care Excellence (NICE) guidelines.Aims: This review audit was carried out to:To identify the total number of patients with confirmed diagnosis ofAbdominal Aortic Aneurysm (AAA) within the GP Practice who werecurrently taking statins.To confirm how many of these patients have had a previous encounterwith a physician in the practice regarding Statin prophylaxis.To confirm the number of patients who are not currently takingstatins, have no contraindication, and have not had discussion with a clinicianregarding statin prophylaxis.To create awareness for clinicians and patients regarding NICE guidanceon statin prophylaxis.Method: A retrospective review of clinical records was conducted viaSystemone for all the patients with AAA in the SLC practice. Then, inclusionand exclusion criteria were applied to identify those on prophylactic statins.Results: Of the 36 patients with AAA records retrieved, fewer than 2% ofpatients who satisfied the inclusion criteria were not prescribed statins.Conclusion: Lack of awareness of the NICE guideline regarding statinprophylaxis in patients with AAA may contribute significantly to thisoutcome. Therefore, practice clinicians are to be educated on NICEguidelines regarding statin prophylaxis in patients with AAA. Also, anautomated message can be created for patients with AAA, to book anappointment with the clinician and discuss the use of statin.

Cauda equina syndrome in the emergency department: a 2-year retrospective review

Cauda equina syndrome if a rare but life-changing clinical condition inwhich pressure is exerted on the group of nerve roots known collectivelyas cauda equina.It was first described in 1934. It has an incident ranging from 2.7 to4.0 per 100,000.It is more common in women with a mean age of 42 years.It can lead to loss of control of pelvic organs and legs, with a risk ofpermanent loss of sensory and motor control in the area supplied by thecauda equina.The setting for the study was the emergency department in a LargeUrban Teaching Hospital. A Retrospective Chart Review over 2 yearsfrom January 2022 to December 2023 was conducted. Adult patientsaged 18 years and over presenting with suspected cauda equina syndrome(CES) were included. We found a CES prevalence of 0.07% of all EDattendances or 74 per 100,000. There was a female preponderance of70% versus 30% male. A total of 74% of cases were aged between 24and 65 years at one peak, and a spike after the age of 75 years. Mostcases (92%) were managed conservatively. A total of 100 patients (68%)were admitted or transferred, while 32% were discharged. A total of 140patients (95%) met the National Institute for Health and Care Excellence(NICE) red flag symptoms. In conclusion, CES is rare (< 0.5% of ED presentations). There was anage peak between 25 and 65 years, with a spike after the age of 75 years.It has a large female preponderance in keeping with the observation fromother studies. Ninety five per cent of cases in our cohort met the NICEred flag criteria. Most cases were managed locally and conservatively.

Prevention of infective endocarditis in at-risk patients: how should dentists proceed in 2024?

National Institute for Health and Care Excellence (NICE) guidelines are ambiguous over the need for patients at increased risk of infective endocarditis (IE) to receive antibiotic prophylaxis (AP) prior to invasive dental procedures (IDPs), and this has caused confusion for patients and dentists alike. Moreover, the current law on consent requires clinicians to ensure that patients are made aware of any material risk they might be exposed to by any proposed dental treatment and what can be done to ameliorate this risk, so that the patient can decide for themselves how they wish to proceed. The aim of this article is to provide dentists with the latest information on the IE-risk posed by IDPs to different patient populations (the general population and those defined as being at moderate or high risk of IE), and data on the effectiveness of AP in reducing the IE risk in these populations. This provides the information dentists need to facilitate the informed consent discussions they are legally required to have with patients at increased risk of IE about the risks posed by IDPs and how this can be minimised. The article also provides practical information and advice for dentists on how to manage patients at increased IE risk who present for dental treatment.

Immune Responses to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccines: Updated Insights

Background: Using a multidisciplinary approach, this review explores and investigates the relationship between immune responses, effectiveness, and results of various vaccination strategies among a range of demographics. Moreover, this review aims to aid healthcare professionals in understanding the intricacies of immune responses and their implications for future vaccine development.Methodology: In this systematic review, we employed an electronic online database platform including the National Centre for Biotechnology Information (NCBI), the National Institute for Health and Clinical Excellence (NICE), and the World Health Organization (WHO) for evidence-based material, utilizing the keywords throughout this literature review.Results: This review provides a detailed framework regarding immune responses to the COVID- 19 vaccine, based on demographics, age, sex, types of immunity, and immunization strategies. Such research can provide important academic support for the development of not only COVID- 19 vaccines but also other vaccines.Conclusions: Overall, immune responses tended to dwindle a few months after vaccine administration. This is because B cells block SARS-CoV-2 from infecting cells via antibodies and T cells destroy infected cells. The most efficient tool for providing long-lasting protection against SARS-CoV-2 is vaccination. Humans have developed immunity to SARS-CoV-2, particularly antibody-mediated humoral immunity. The development of vaccines across the whole family of coronaviruses that target antibody epitopes (antigenic determinants) prevents the emergence of mutant strains.

Predicting the risk of pancreatic cancer in adults with new-onset diabetes: development and internal-external validation of a clinical risk prediction model.

The National Institute for Health and Care Excellence (NICE) recommends that people aged 60+ years with newly diagnosed diabetes and weight loss undergo abdominal imaging to assess for pancreatic cancer. More nuanced stratification could lead to enrichment of these referral pathways. Population-based cohort study of adults aged 30-85 years at type 2 diabetes diagnosis (2010-2021) using the QResearch primary care database in England linked to secondary care data, the national cancer registry and mortality registers. Clinical prediction models were developed to estimate risks of pancreatic cancer diagnosis within 2 years and evaluated using internal-external cross-validation. Seven hundred and sixty-seven of 253,766 individuals were diagnosed with pancreatic cancer within 2 years. Models included age, sex, BMI, prior venous thromboembolism, digoxin prescription, HbA1c, ALT, creatinine, haemoglobin, platelet count; and the presence of abdominal pain, weight loss, jaundice, heartburn, indigestion or nausea (previous 6 months). The Cox model had the highest discrimination (Harrell's C-index 0.802 (95% CI: 0.797-0.817)), the highest clinical utility, and was well calibrated. The model's highest 1% of predicted risks captured 12.51% of pancreatic cancer cases. NICE guidance had 3.95% sensitivity. A new prediction model could have clinical utility in identifying individuals with recent onset diabetes suitable for fast-track abdominal imaging.

Abstract PO3-17-12: Safety and efficacy of Atezolizumab in combination with nab-Paclitaxel in patients with PD-L1 positive metastatic or locally advanced triple-negative breast cancer: A pan-UK cancer centre experience

Abstract BACKGROUND Within the United Kingdom (UK), combination chemo-immunotherapy with Atezolizumab and nab-Paclitaxel is National Institute for Health and Care Excellence (NICE) approved as a first line palliative systemic treatment option for patients with advanced triple-negative breast cancer (aTNBC) with programmed death-ligand 1 (PD-L1) expression ≥1%. Trials demonstrated progression-free survival (PFS) and overall survival (OS) benefits. Treatment-related toxicities may impact on quality of life and result in treatment delay or discontinuation. We conducted a National Service Evaluation (SE) to assess the safety and efficacy in a “real-world” dataset. METHODS Data from patients with aTNBC who received Atezolizumab/nab-Paclitaxel between 9th March 2019 and 2022 across 10 UK Cancer Centres were analysed. All grade 1-4 toxicities were recorded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scoring system. Participation was contingent on local approval for this project, and data transferred following receipt of a data sharing agreement. Kaplan-Meier curves for PFS and OS were calculated. RESULTS 129 patients were included in the analysis with a median age of 55 (30-82). 42.6% (n=55) had a PS of 0, 51.2% (n=66) a PS of 1 and 3.9% (n=5) had a PS of 2. Atezolizumab/nab-Paclitaxel was given in the first line setting in most patients (84.5%, n= 109), but in 15.5% (n=20) in the second line setting (privately insured). 21.7% (n=28) of patients presented with de novo metastatic disease, 58.1% (n=75) of patients were post-menopausal and 6.2% (n=8) had a BRCA1 or 2 mutation. 76.7% of patients (n=99) had previous neo-/adjuvant treatment in the non-metastatic setting: 55.8% had prior treatment with a taxane, 51.2% anthracycline, 22.5% platinum, and 66.7% had prior radiotherapy. 83.7% (n= 108) had invasive ductal breast cancer, and 84.5% (n=109) presented with 0-3 number of metastatic sites with 15.5% (n=20) having ≥ 4 metastatic sites. Here, the nodal metastatic site dominated in 78.3% of patients. Grade ≥ 3 events occurred in 21.7% (n=28) of patients. These were decreased neutrophil count (10.1%, n=13), pyrexia (2.3%, n=3), diarrhoea (1.6%, n=2), hypothyroidism (1.6%, n=2), peripheral neuropathy (1.6%, n=2), anaemia (1.6%, n=2), GGT rise (0.8%, n=1), fatigue (0.8%, n=1), hypophysitis (0.8%, n=1), pneumonitis (0.8%, n=1), nausea (0.8%, n=1), mucositis (0.8%, n=1), platelet count decreased (0.8%, n=1), infections (0.8%, n=1). Increased rates of Grade ≥ 3 colitis (2.3%, n=3) and hepatitis (3%, n=2.3) were observed. 20.2% (n=26) of patients required steroids to treat toxicities. Reason for treatment discontinuation included in 58.1% (n=75) disease progression, and 7.8% (n=10) unacceptable toxicity. In 22.5% of patients’ treatment was still ongoing at time of data lock. At approximately 12 weeks, 7.8% of patients had a complete and 51.2% a partial response, 10.1% had stable and 22.5% progressive disease and for 8.5% the response was not known as they have not yet reached 12 weeks since treatment start. Median PFS was 5 months and OS was 14 months. CONCLUSIONS The toxicity profile of Atezolizumab/nab-Paclitaxel was comparable to literature, however, both PFS and OS were shorter. In comparison to the IMpassion130 trial data, patients within this national SE project were less fit and more heavily pre-treated. A higher number of any grade hyperthyroidism and fatigue, and of grade ≥ 3 colitis and hepatitis were noticed. Baseline patient characteristics XX- XX Citation Format: Jasmin V Waterhouse, Alexandra Holdich, Florentia Mina, Mariam Obeid, Kroopa Joshi, Sophie Barrett, Lavarniya Rajakumar, Gemma McCormick, Sally Seymour, Panagiotis Koliou, Rushan Sylva, Olubukola Ayodele, Ashram Gautam, Jenny Smith, Jenny McKeon, Thomas Strawson-Smith, Rosalie Douglas, Annabel Borley, Apostolos Konstantis, Sophie McGrath. Safety and efficacy of Atezolizumab in combination with nab-Paclitaxel in patients with PD-L1 positive metastatic or locally advanced triple-negative breast cancer: A pan-UK cancer centre experience [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-17-12.

Is there any difference between Eastern and Western clinical practice guidelines in management of gastric cancer?

Gastric cancer (GC) has been known as one of the most common causes of cancer mortality both in Western and Eastern countries. However, there might be differences between how it is managed in different countries. Thus, we aimed to investigate these differences. The most well-known clinical guidelines in field of GC management including Korean GC Association (KGCA), Japanese GC Association (JGCA), National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO), British Society of Gastroenterology (BSG), and National Institute for health and Care Excellence (NICE) have been reviewed. The contents of these guidelines were categorized under eight headings including (1) genetic predisposition, (2) prevention, (3) management of gastric polyp, atrophy, dysplasia and metaplasia, (4) diagnosis, (5) pathology and molecular biology, (6) treatment, (7) supportive and palliative care, and (8) follow up. Difference in each section was discussed. Considering KGCA and JGCA as Eastern and NCCN, ESMO, BSG, and NICE as Western guidelines, it is revealed that both sets of guidelines share common practices such as prioritizing comprehensive diagnostic evaluations, personalizing treatment plans, and palliative care. However, main differences can be seen in treatment regimens, the adoption of newer therapies like immunotherapy, and the utilization of emerging techniques such as HIPEC. These differences reflect the diverse clinical landscapes, research focuses, and healthcare systems within these regions.

An NHS Trust comparison of reporting radiographers and consultant radiologists ability to identify cancer on chest radiographs with confirmation through a Fast track CT thorax referral system

IntroductionThe National Institute for Health and Care Excellence (NICE) recommends that GPs initially refer patients with suspected lung cancer for a chest X-ray (CXR). The Radiology department has a ‘fast track system’ to identify those patients who may have lung cancer on CXR and are referred for a CT thorax with contrast to help determine a cancer diagnosis. This fast track system was put in place to ensure the NICE guidelines and NHS England's standards on a faster cancer diagnosis are being met. This audit studied the ability of radiologists and reporting radiographers to identify lung cancer on CXRs and the accuracy of the fast-track system. Methods846 cases with lung alerts were analysed and 545 CXRs were audited. The CXRs were split into images reported by radiologists (168) and those reported by reporting radiographers (377). CT thorax results were collected through PACS and Cerner computer systems to identify if the ‘fast track’ system had yielded a “positive”, “negative”, or “other findings” result for lung cancer. Results32.8% (179) of CXRs flagged for lung cancer were positive, 40.6% (221) were negative, and 26.6% (145) had other findings. Chi square statistical test showed no significant difference (p = 0.14) between the two reporting groups in their ability to identify lung cancer on CXRs. 27% (38) of CXRs flagged by radiologists and 35% (125) by reporting radiographers were positive for lung cancer. ConclusionThis clinical audit indicates, reporting radiographers and radiologists are not statistically significantly different regarding their ability to identify lung cancer on CXRs, when supported by the fast track system. The fast-track system had a 59.4 % accuracy rate, detected by the number of imaging of reports that identified a serious pathology. This concludes that the system is performing well, yet could still be improved. Implications for practiceThis audit provides further evidence for the value of developing and deploying reporting radiographers for projection radiography reporting.

EXERCISE IS MEDICINE, BUT FOR WHAT? A MAPPING REVIEW OF PHYSICAL ACTIVITY RECOMMENDATIONS IN THE UK NICE CLINICAL GUIDELINES

INTRODUCTION & AIMS Clinical guidelines are used to inform best practice care, with research evidence a key aspect informing guideline recommendations. Physical activity is recommended for the management of a large variety of health conditions; however, the conditions that physical activity is recommended for has not been synthesised, nor has the quality of the evidence that informs these guideline recommendations. METHODS To understand the extent and type of evidence for physical activity recommendations across different health conditions in the UK National Institute for Health and Care Excellence (NICE) clinical guidelines. METHODS NICE was searched for clinical guidelines that recommended physical activity in the management/treatment of a health condition. Data relating to the condition, guideline date, physical activity recommendation(s) (general or specific), and evidence underpinning the recommendations was extracted. Where applicable, recommendations for research, priorities for implementation, and impact of the recommendations was also extracted. RESULTS 221 clinical guidelines were reviewed, of which 52 provided one or more physical activity recommendations and were included in the analysis. The guidelines covered a range of conditions including cardiovascular, mental health, metabolic, neurological, musculoskeletal, and others. Most guidelines (n=43) provided general physical activity recommendations (e.g. advice to be active) whereas only 9 provided specific recommendations (e.g. type and dose of physical activity). The evidence underpinning the physical activity recommendations in the guidelines was mixed but was mostly based on very low-moderate quality evidence. Despite this, few guidelines recommended further research around physical activity. CONCLUSION Physical activity is recommended in many clinical guidelines, demonstrating its perceived importance for improving health across a wide range of different conditions. The mostly low-quality evidence on which these recommendations are based questions why more guidelines do not recommend further high-quality research into physical activity. This would improve confidence in the evidence and hence confidence in the recommendations made by the guidelines.

Impact of sociodemographic patient factors on prescriber adherence to antihypertensive prescription guidelines: a cross-sectional study using data from The Irish Longitudinal Study on Ageing

Abstract Introduction Uncontrolled hypertension causes significant morbidity and mortality worldwide. Several international prescribing guidelines have been created to address this. However, prescriber adherence to these guidelines may be influenced by sociodemographic patient factors such as socio-economic status, gender and age. Aim To examine the effects of gender and other patient factors, including age, geographical location, educational attainment, duration of disease, socio-economic status, smoking status, and previous history of cardiovascular diseases on prescriber adherence to hypertension prescription guidelines. Achievement of blood pressure goals (<140/90 mmHg) with adherence to prescription guidelines was also assessed. Methods This study is a secondary analysis of cross-sectional data from the first wave (2009-2011) of The Irish Longitudinal Study on Ageing (TILDA), which included 8,175 Irish adults ≥50 years of age. Participants were included in the present study if they reported a previous doctor diagnosis of hypertension. Antihypertensive medication regimens were compared and categorised according to the 2011 National Institute for Health and Clinical Excellence (NICE)[1] prescription guidelines, which included the use of angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, calcium channel blockers, and thiazide diuretics in the treatment of hypertension. In this study, the antihypertensive medication regimens of participants were categorised based on age categories (<55, ≥55, and all age groups), and compared to the 2011 NICE Guidelines which differentiate treatment in those ≥55, and <55 years of age. The effects of patient sociodemographic factors on prescriber adherence to the guidelines, and the effects of guideline adherence on blood pressure control, (defined as blood pressure<140/90 mmHg), were determined using multinomial logistic regression models. The mlogit, RRR code in STATA 17 SE was used to report relative risks (RRs). Results A total of 2,992 participants were included, of whom 54.9% were women. The mean age of participants was 65.69 years (±9.23). Male gender, older age and lower socioeconomic status among participants were associated with increased prescriber guideline adherence. Prescribers were less likely to adhere to guidelines in female patients ≥55 years (RR 0.75 [0.62 to 0.91]), and female patients across all age groups (RR 0.80 [0.67 to 0.95]). Better blood pressure control was seen with medication regimens adherent to prescription guidelines with a mean of 140.38 (±18.98)/83.09 (±11.02) mmHg compared to a mean of 141.66 (±19.86)/84.77 (±11.71) mmHg in those non-adherent to guidelines. Conclusion This study highlights the effects of patient gender on prescriber adherence to antihypertensive prescription guidelines. A study strength is the use of a large, nationally representative cohort that used a standardised protocol of data collection within the Irish population. A potential limitation is the inclusion of self-reported data, including doctor diagnosis of hypertension. The results of this study may emphasise a larger issue of the systemic undertreatment of women within healthcare; however, these results should be interpreted in the context of 2011 guidelines, which have since been superseded by 2019 NICE guidelines. Further research may seek to determine possible reasons for such differences in hypertensive care. Reference 1. Linden B. NICE guidance on primary hypertension National Institute for Health and Clinical Excellence (2011) Hypertension: Clinical Management of Primary Hypertension in Adults. NICE Clinical Guideline 127. British journal of cardiac nursing. 2011;6:582-584.

Understanding how a non-National Institute for Health and Care Excellence technology appraisal drug is added to the hospital drug formulary

Abstract Introduction In England, only medications listed in a hospital formulary can be used to treat patients in a National Health Service (NHS) hospital. Medications approved by the National Institute for Health and Care Excellence (NICE) via technology appraisal (TA)1 are included in hospital formularies.[1] Non-NICE TA medications need to be reviewed by the hospital’s drug and therapeutics committee (DTC) for inclusion in the hospital formulary. Research shows that different DTCs make contrary decisions concerning the same non-NICE TA drug request for inclusion in the hospital formulary, contributing to postcode prescribing and inequality in medication access.[2] To understand how and why different DTCs make different decisions, it is vital to understand how a non-NICE TA drug is added to a hospital formulary. Aim To identify the process and variations when adding a non-NICE TA drug to a hospital formulary. Methods As part of a larger study, the DTC of a tertiary centre where this research was based developed and sent a questionnaire exploring DTC processes to Chief Pharmacists (via Microsoft Forms) of ten large tertiary centres in England. After completing the questionnaire, a semi-structured interview was conducted with each Chief Pharmacist to clarify ambiguity in the questionnaire responses. Only data regarding how a non-NICE TA is added to the hospital formulary was used in this study. A hierarchical task analysis (HTA) was developed; data were analysed using inductive thematic analysis to identify subgoals, tasks and subtasks required to add a non-NICE TA drug to the hospital formulary. The HTA was developed iteratively. Results A total of ten Chief Pharmacists (100% of those approached) completed both the questionnaire and interview. Adding a non-NICE TA drug starts with the applicant requesting and completing an application package, followed by obtaining approval to submit the application package for review. Once approval is granted, the application package goes through three review levels: initial, preliminary, and final review. The non-NICE TA drug is added to the formulary once the application package is clinically and financially approved. This process involves over 100 tasks and subtasks. The process described varied from one centre to another with the following main variations: 1. application package components, 2. how the application package is submitted for approval, 3. the depth of review the application package receives, and 4. how the final review is conducted. Conclusion Adding a non-NICE TA drug to a hospital formulary is complex and varied across each centre, indicating a lack of national standardisation in the process. The variations identified could contribute to health inequalities as all patients may not have equal access to the same medications. Therefore, further research is required to study the impact of these variations on patient access to medication via the NHS. Currently, there are no studies in the literature that described the process of adding a non-NICE TA drug to the hospital formulary across the tertiary centres in England. The study only included tertiary centres in England and there should be caution when considering the transferability of the findings to other types of hospitals.

Cost-effectiveness of surgery for degenerative cervical myelopathy in the United Kingdom

Purpose Degenerative cervical myelopathy (DCM) is the commonest cause of adult spinal cord dysfunction worldwide, for which surgery is the mainstay of treatment. At present, there is limited literature on the costs associated with the surgical management of DCM, and none from the United Kingdom (UK). This study aimed to evaluate the cost-effectiveness of DCM surgery within the National Health Service, UK. Materials and Methods Incidence of DCM was identified from the Hospital Episode Statistics (HES) database for a single year using five ICD-10 diagnostic codes to represent DCM. Health Resource Group (HRG) data was used to estimate the mean incremental surgery (treatment) costs compared to non-surgical care, and the incremental effect (quality adjusted life year (QALY) gain) was based on data from a previous study. A cost per QALY value of <£30,000/QALY (GBP) was considered acceptable and cost-effective, as per the National Institute for Health and Clinical Excellence (NICE) guidance. A sensitivity analysis was undertaken (±5%, ±10% and ±20%) to account for variance in both the cost of admission and QALY gain. Results The total number of admissions for DCM in 2018 was 4,218. Mean age was 62 years, with 54% of admissions being of working age (18–65 years). The overall estimated cost of admissions for DCM was £38,871,534 for the year. The mean incremental (per patient) cost of surgical management of DCM was estimated to be £9,216 (ranged £2,358 to £9,304), with a QALY gain of 0.64, giving an estimated cost per QALY value of £14,399/QALY. Varying the QALY gain by ±20%, resulted in cost/QALY figures between £12,000 (+20%) and £17,999 (−20%). Conclusions Surgery is estimated to be a cost-effective treatment of DCM amongst the UK population.

P081 Out-patient management of gout in secondary care: Results from the North West regional audit

Abstract Background/Aims Recommendations for gout management have significantly evolved as outlined by the latest National Institute for Health and Care Excellence (NICE), European League Against Rheumatism (EULAR), British Society for Rheumatology (BSR) and the Medicines and Healthcare products Regulatory Agency (MHRA) guidelines, with increased emphasis being placed on optimising cardiovascular risk. This regional audit aimed to assess concordance with these guidelines within rheumatology outpatient settings in the North West region of England. Methods New or follow-up patients with gout, presenting to a rheumatology outpatient setting within the Greater Manchester and Lancashire area over a five-week period between 1/3/23 and 7/4/23 were included. We collated data on demographics, co-morbidity assessment including cardiovascular risk, prescribing of febuxostat in major cardiovascular disease, diuretic use and advice, setting of treat-to-target levels, use of cardiovascular risk prediction tools and subsequent follow up arrangements. For new patients, collected data also included referral reason, and prescription recommendations for first-line urate-lowering therapy (ULT) and co-prescriptions for flare prophylaxis. Results Ninety-two patients (mean age 60 years, 80% male) were included from 13 rheumatology departments. Twenty-three patients were new referrals. Sixty-seven patients (73%) had ≥ 1 relevant comorbidity; hypertension being the most common (55%). Twenty (22%) patients were on diuretics. Twelve (55%) of these patients had a diagnosis of hypertension without heart failure; none received recommendations to reduce or stop diuretics. In line with current guidelines, no patient with major cardiovascular disease was treated with febuxostat. Treat-to-target levels were agreed in 49 (57%) applicable patients. Cardiovascular prediction tools were only calculated or known in three (3%) patients. However, clinic data collected would have allowed a risk assessment calculation in 13 (14%) patients. Sixteen (17%) patients audited had no planned follow-up. Compared to NICE guidelines, 18 (78%) new patients reviewed in clinic were referred appropriately to rheumatology services. Twenty-two (96%) new patients referred were eligible to start ULT, of which 15 (75%) were started on a NICE/ EULAR recommended first-line ULT treatment (14 patients on allopurinol including 11 patients with no major cardiovascular disease, one patient on febuxostat). Eleven (79%) patients started on allopurinol were initiated on a low dose (50-100mg), as recommended by NICE and the BSR. Ten (67%) patients of those initiated on ULT were also prescribed prophylactic colchicine. Two additional patients were prescribed NSAIDs with PPI cover and one patient was prescribed oral steroids without PPI cover. Conclusion Most new patients were referred and prescribed first-line ULT treatment appropriately, often with colchicine prophylaxis. Uptake of febuxostat as first-line therapy was limited. Cardiovascular risk assessment was rarely done; further work exploring barriers to undertaking these assessments in rheumatology clinics is likely to improve both patient care and guideline compliance. Disclosure L. Gould: Other; L.G. has received conference fees from Eli Lilly. A. Richards: None. L. Gray: Other; L.G. has received travel and conference fees from Eli Lilly. M. Badarulla: Other; M.B. has received conference fees from Eli Lilly. L. Mercer: Other; L.M. has received conference fees from Nordic Pharma and UCB. R. Farid: None. R. Heaton: Consultancies; R.H. has received consultancy fees from Galapagos. Honoraria; R.H. has received speaker honorarium from Abbvie and Nordic. Other; R.H. has received conference fees from UCB. M. Al-Attar: None. M. Whitehead: None. S. Kamath: None. L. Teh: None. A. Odekunle: None. C.A. Sharp: None. A. Babiker: None. S. Hopping: None. A. Oldroyd: None. K. Lazarewicz: None. C. Saleh: None. S. Horton: None. D. Roy: Honoraria; D.R. has an honorary University of Manchester research assistant contract. A. Opeseyitan: None. D. Das: None. S. Varughese: None. D. Yidana: None. S. Wig: None. J. Bluett: Grants/research support; J.B. has received a research grant award from Pfizer. Other; J.B. has received travel/conference fees from UCB, Fresenius Kabi, Pfizer and Eli Lilly.

P039 A systematic review and meta analysis of anti rheumatic drugs and pneumococcal vaccine immunogenicity in inflammatory arthritis

Abstract Background/Aims Pneumococcal pneumonia is an important cause of morbidity and mortality amongst patients with inflammatory arthritis. Vaccination is recommended by the National Institute of Clinical Excellence (NICE) but it remains unclear how vaccine efficacy is impacted by different immunosuppressive agents. Our objective was to compare the chance of a seroconversion following vaccination against pneumococcus in patients with inflammatory arthritis to the general population as well as to compare the chance of seroconversion across different targeted therapies. Methods We searched MEDLINE, Embase and the Cochrane library databases from inception until 20th June 2023. We included randomised controlled trials and observational studies. Aggregate data were used to undertake pairwise meta-analysis. Our primary outcome of interest was vaccine seroconversion. We accepted the definition of serological response reported by the authors of each study. Results 20 studies identified in the systematic review (2,807 patients) with 10 reporting sufficient data to be included in the meta-analysis (1,443 patients). The odds of seroconversion in patients receiving targeted therapies, relative to the general population, was 0.61 (95% CI 0.35 to 1.08). The reduced odds of response was skewed strongly by the effects of abatacept and rituximab with no difference between patients on TNF inhibitors or IL6 inhibition and healthy controls. In the analysis comparing within inflammatory arthritis populations the findings remained consistent with rituximab having the strongest negative impact on vaccine response. TNF inhibition monotherapy associated with a greater odds of vaccine response compared with methotrexate (2.25 (95% CI 1.28 to 3.96)). JAK inhibitor studies were few in number and did not present comparable vaccine response endpoints to include in meta-analysis. The information available does not suggest a significant detrimental effects of JAK inhibitor on vaccine response. Conclusion This updated meta-analysis confirms that for the majority of patients with inflammatory arthritis, pneumococcal vaccine can be administered with confidence that it will achieve comparable seroconversion rates to the healthy population. Patients on rituximab were the group least likely to achieve a response and further research is needed to explore the value of multiple course pneumococcal vaccination schedules in this population. Disclosure D. Nagra: Honoraria; Abbvie, Galapagos, UCB. K. Bechman: None. M. Adas: None. Z. yang: None. E. Alveyn: None. S. Patel: None. M. Russell: None. S. Norton: None. C. Wincup: None. C. Baldwin: None. J. Galloway: None.

Concordance between ER, PR, Ki67, and HER2-low expression in breast cancer by MammaTyper RT-qPCR and immunohistochemistry: implications for the practising pathologist.

There are limited data on the role of multigene tests and their correlation with immunohistochemistry (IHC), especially on core biopsy. MammaTyper is a quantitative conformite Europeeanne (CE) marked, National Institute for Health and Care excellence (NICE) approved, in in vitro diagnostic quantitative real-time polymerase chain reaction (RT-qPCR) test for assessment of mRNA expression of four biomarkers (ESR1, PGR, ERBB2, MKI67). We evaluated the concordance of MammaTyper with oestrogen receptor (ER), progesterone receptor(PR), HER2, and Ki67 by IHC on 133 core needle biopsies of breast cancer. HER2 was positive if IHC 3+ or 2+ and fluorescence in situ hybridization (FISH)-amplified. Global and hotspot Ki67 expression was analysed using a cutoff of ≥20% assessed manually and by digital image analysis. Agreements were expressed as overall percent agreement (OPA), positive percent agreement (PPA), negative percent agreement (NPA), and Cohen's kappa. RT-qPCR results of ESR1 were highly concordant with IHC with OPA of 94.7% using 1% cutoff and 91.7% when the low ER-positive category was included. The PPA and NPA between RT-qPCR and IHC for PR was 91.5% and 88.0%, respectively, when using the 1% cutoff. For ERBB2/HER2, the OPA was 95% and the PPA was 84.6%. 40 of 72 HER2 IHC score 0 tumours were classified as ERBB2 low. Best concordance between MKI67 by MammaTyper and Ki67 IHC was achieved using hotspot digital image analysis (OPA: 87.2%, PPA: 90.6%, NPA: 80%). RT-qPCR-based assessment of the mRNA expression of ESR1, PGR, ERBB2, and MKI67 showed high concordance with IHC, suggesting that the MammaTyper test on core needle biopsies represents a reliable, efficient, and reproducible alternative for breast cancer classification and refining HER2 low categorisation.

Clinical practice guidelines for diagnostic and treatment of the chronic heart failure.

Chronic heart failure continues to be one of the main causes of impairment in the functioning and quality of life of people who suffer from it, as well as one of the main causes of mortality in our country and around the world. Mexico has a high prevalence of risk factors for developing heart failure, such as high blood pressure, diabetes, and obesity, which makes it essential to have an evidence-based document that provides recommendations to health professionals involved in the diagnosis and treatment of these patients. This document establishes the clinical practice guide (CPG) prepared at the initiative of the Mexican Society of Cardiology (SMC) in collaboration with the Iberic American Agency for the Development and Evaluation of Health Technologies, with the purpose of establishing recommendations based on the best available evidence and agreed upon by an interdisciplinary group of experts. This document complies with international quality standards, such as those described by the US Institute of Medicine (IOM), the National Institute of Clinical Excellence (NICE), the Intercollegiate Network for Scottish Guideline Development (SIGN) and the Guidelines International Network (G-I-N). The Guideline Development Group was integrated in a multi-collaborative and interdisciplinary manner with the support of methodologists with experience in systematic literature reviews and the development of CPG. A modified Delphi panel methodology was developed and conducted to achieve an adequate level of consensus in each of the recommendations contained in this CPG. We hope that this document contributes to better clinical decision making and becomes a reference point for clinicians who manage patients with chronic heart failure in all their clinical stages and in this way, we improve the quality of clinical care, improve their quality of life and reducing its complications.

Time to unshackle the medical treatment of obesity in the NHS

Obesity affects 1 in 4 people in the United Kingdom and costs the National Health Service (NHS) ∼£6.5 billion annually. The glucagon-like peptide-1 (GLP-1) receptor analogues, such as once-daily subcutaneous Liraglutide 3.0 mg (Saxenda®) and once-weekly subcutaneous Semaglutide 2.4 mg (Wegovy®), were approved by the National Institute of Clinical Excellence (NICE) as a treatment for obesity and funded by the NHS for 2 years. Our local data shows that Saxenda is effective at reducing bodyweight and glycaemia in people with obesity and diabetes however, the supply issues of GLP-1 receptor analogues has contributed to the unavailability of Saxenda and Wegovy in our service. Our patients are devastated that they cannot access NICE-approved GLP-1 receptor analogues for obesity. The 2-year GLP-1 receptor analogue treatment limit for obesity alongside a lack of funded NHS services and supply issues represent barriers to treatment for people living with obesity who have clear medical indications.

Evaluating clinical practice guidelines for the management of rectal cancer: Did they get it RIGHT?

Clinical Practice Guidelines (CPGs) are crucial tools for clinicians seeking to deliver evidence-based patient care. We utilized the Reporting Items for practice Guidelines in HealThcare (RIGHT) checklist to assess the reporting quality of CPGs addressing the management of rectal cancer. Four multidisciplinary rectal cancer CPGs published 2017-2022 were evaluated: American Society of Colon and Rectal Surgeons (ASCRS), European Society for Medical Oncology (ESMO), National Comprehensive Cancer Network (NCCN), and National Institute for Health and Care Excellence (NICE). We quantitatively assessed each CPG using the RIGHT checklist and qualitative analysis was performed to generate common themes. RIGHT checklist items fulfilled by each CPG ranged from 12 to 17 (out of 22). Each guideline demonstrated unique categories of weakness: ASCRS in Basic Information (1 of 4 items), ESMO in Evidence (1 of 3), NCCN in Recommendations (1 of 3), and NICE in Review and Quality Assurance (0 of 2). Common themes that emerged included sprase discussion on the financial aspects of rectal cancer management and lack of transparency in formulating recommendations. Despite their variability, each of the 22 checklist elements are present in contemporary CPGs. Utilizing the RIGHT checklist would allow experts to create guidelines adhering to high-quality reporting standards.

Prospective multicenter evaluation of adherence to the Dutch guideline for children aged 0-16years with fever without a source-febrile illness in children (FINCH) study.

We found a high non-adherence rate of 48%, which did not lead to unfavorable clinical outcomes. This substantiates the need for a critical reevaluation of the FWS guideline and its indications for bacterial cultures, viral testing, and antibiotic treatment. • Despite the development of national guidelines, variation in practice is still substantial in the assessment of febrile children to distinguish severe infection from mild self-limiting disease. • Previous retrospective research suggests low adherence to national guidelines for febrile children in practice. • In case of non-adherence to the Dutch national guideline, similar to the National Institute for Health and Care Excellence (NICE) guideline from the United Kingdom, physicians have used fewer resources than the guideline recommended without increasing missed severe infections.