NICE Guidance Research Articles

P14 Procalcitonin evaluation of antibiotic use in COVID-19 hospitalized patients during the first wave of COVID-19: the PEACH study

BackgroundA minority of patients presenting to hospital with COVID-19 have bacterial coinfection. Procalcitonin testing may help identify patients for whom antibiotics should be prescribed or withheld. The PEACH study describes the use of procalcitonin in English and Welsh hospitals during the first wave of the COVID-19 pandemic to help diagnose bacterial infections and guide antibiotic treatment. There is a lack of clear evidence to support its use in lung infections, which means in some hospitals, clinicians have used the procalcitonin test to guide antibiotic decisions in COVID-19, whilst in other hospitals, they have not. Our study is analysing data from hospitals that did and did not use procalcitonin testing during the first wave of the COVID-19 pandemic. It will determine whether and how procalcitonin testing should be used in the NHS in future waves of COVID-19 to protect patients from antibiotic overuse.MethodsTo assess whether the use of PCT testing, to guide antibiotic prescribing, safely reduced antibiotic use among patients who were hospitalized with COVID-19 during the first wave of the pandemic, we are answering this question through three different, and complimentary, work streams (WS), each with discrete work packages (WP): (i) Work Stream 1: utilization of PCT testing to guide antibiotic prescribing during the first wave of COVID-19 pandemic; (ii) Work Stream 2: patient-level impact of PCT testing on antibiotic exposure and clinical outcome (main work stream currently in analysis); and (iii) Work Stream 3: health economics analysis of PCT testing to guide antibiotics in COVID-19.ResultsOur first publication from Work Stream 1 (Antibiotics 2021, 10: 516) used a web-based survey to gather data from antimicrobial leads about the use of procalcitonin testing. Responses were received from 148/151 (98%) eligible hospitals. During the first wave of the COVID-19 pandemic, there was widespread introduction and expansion of PCT use in NHS hospitals. The number of hospitals using PCT in emergency/acute admissions rose from 17 (11%) to 74/146 (50.7%) and use in ICU increased from 70 (47.6%) to 124/147 (84.4%). This increase happened predominantly in March and April 2020, preceding NICE guidance. Approximately half of hospitals used PCT as a single test to guide decisions to discontinue antibiotics and half used repeated measurements. There was marked variation in the thresholds used for empirical antibiotic cessation and guidance about interpretation of values.ConclusionsProcalcitonin testing has been widely adopted in the NHS during the COVID-19 pandemic in an unevidenced, heterogeneous way and in conflict with relevant NICE guidance. Further research is needed urgently that assesses the impact of this change on antibiotic prescribing and patient safety. Work Stream 2 is ongoing, and results will be published once available.

A cluster randomised controlled trial of a ward-based intervention to improve access to psychologically-informed care and psychological therapy for mental health in-patients

BackgroundThere is good evidence that psychological interventions improve patient well-being and independent living, but patients on acute mental health wards often do not have access to evidence-based psychological therapies which are strongly advised by NICE guidance for severe mental health problems. The overall aim of this programme of work is to increase patient access to psychological therapies on acute mental health inpatient wards. Stage one of the programme (which is complete) aimed to identify barriers and facilitators to delivering therapy in these settings through a large qualitative study. The key output of stage one was an intervention protocol that is designed to be delivered on acute wards to increase patient access to psychologically-informed care and therapy. Stage two of the programme aims to test the effects of the intervention on patient wellbeing and serious incidents on the ward (primary outcomes), patient social functioning and symptoms, staff burnout, ward atmosphere from staff and patient perspectives and cost effectiveness of the intervention (secondary outcomes).MethodsThe study is a single blind, pragmatic, cluster randomised controlled trial and will recruit thirty-four wards across England that will be randomised to receive the new intervention plus treatment as usual, or treatment as usual only. Primary and secondary outcomes will be assessed at baseline and 6-month and 9-month follow-ups, with serious incidents on the ward collected at an additional 3-month follow-up.DiscussionThe key output will be a potentially effective and cost-effective ward-based psychological intervention that increases patient access to psychological therapy in inpatient settings, is feasible to deliver in inpatient settings and is acceptable to patients.Trial Registration numberClinicalTrials.gov Identifier: NCT03950388. Registered 15th May 2019. https://clinicaltrials.gov/ct2/show/NCT03950388

Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: a systematic review and meta-analysis

ObjectiveTo systematically assess the diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children under real-life conditions.DesignSystematic review and meta-analysis.Data sourcesMEDLINE, Embase, Cochrane Database for Systematic...

Prevention and non-surgical management of pelvic floor dysfunction: summary of NICE guidance.

Prevention and non-surgical management of pelvic floor dysfunction: summary of NICE guidance.

Antipsychotics increasingly prescribed for personality disorders, against NICE guidance

Antipsychotics are being increasingly prescribed for long periods for people with personality disorders and no history of severe mental illness, contrary to UK guidelines, a study published in BMJ Open has found. An urgent review of clinical practice is warranted to look at the effectiveness of this prescribing and to monitor adverse effects, the study […]

Effectiveness of the 2-week wait pathway for suspected tonsillar malignancy

Introduction: The Northern Cancer Alliance recommends a 2-week wait cancer pathway for unilateral tonsillar lesion and/or enlargement for assessment of suspected tonsillar malignancy. This is a regional guideline implemented in the North-East England outside of NICE guidance. In this study, we evaluated referrals to our regional unit with unilateral tonsillar lesion and/or enlargement and the effectiveness of this regional 2-week wait criteria.

Sentinel Lymph Node Biopsy for Oral Cancer – When to use it?

Introduction: Sentinel lymph node biopsy (SLNB) for staging tool for oral squamous cell carcinoma (OSCC) was recommended in the 2016 NICE guidance for patients presenting with early (T1 and T2 N0) disease. However, when to deploy SLNB as opposed to elective selective lymphadenectomy (ELND) to detect occult regional metastases remains controversial and is the focus of this study. Methods: A retrospective analysis of 145 patients who had had sentinel lymph node biopsy for a previously untreated primary T1 or T2 oral cancer between 2010 and 2020 was performed. The primary outcome measures of interest were predictors of occult metastases, accuracy of SLNB, disease specific and overall survival. Results: This study reported97% NPV, 7.8% FNR, 2.7% FOR and 92% Sensitivity based on our 145-patient cohort. Depth of invasion (DOI) was a significant predictor of N status, overall survival and disease specific survival.There was a significant difference in the incidence of the neck node metastasis (17.5% vs 36.4%) in patients with DOI <5mm compared to those with DOI >5mm. Conclusions: The selection of SLNB as the preferred staging procedure over ELND requires discussion with patients and should include an estimate of the probability of requiring re-admission for a more complete lymphadenectomy procedure. Introduction: Sentinel lymph node biopsy (SLNB) for staging tool for oral squamous cell carcinoma (OSCC) was recommended in the 2016 NICE guidance for patients presenting with early (T1 and T2 N0) disease. However, when to deploy SLNB as opposed to elective selective lymphadenectomy (ELND) to detect occult regional metastases remains controversial and is the focus of this study. Methods: A retrospective analysis of 145 patients who had had sentinel lymph node biopsy for a previously untreated primary T1 or T2 oral cancer between 2010 and 2020 was performed. The primary outcome measures of interest were predictors of occult metastases, accuracy of SLNB, disease specific and overall survival. Results: This study reported97% NPV, 7.8% FNR, 2.7% FOR and 92% Sensitivity based on our 145-patient cohort. Depth of invasion (DOI) was a significant predictor of N status, overall survival and disease specific survival.There was a significant difference in the incidence of the neck node metastasis (17.5% vs 36.4%) in patients with DOI <5mm compared to those with DOI >5mm. Conclusions: The selection of SLNB as the preferred staging procedure over ELND requires discussion with patients and should include an estimate of the probability of requiring re-admission for a more complete lymphadenectomy procedure.

Updated NICE guidance for type 2 diabetes: what do you need to know?

On 31 March 2022, NICE provided the first substantive update to its ‘Type 2 diabetes in adults: management’ guideline since 2015. With an estimated 4.4 million people living with type 2 diabetes in the UK, it is vital that pharmacists across sectors are aware of these changes to ensure that they provide patients with the […]

Formulating psychosis: a thematic analysis of CBTp trainees’ experiences

AbstractThe NICE guidance states that cognitive behavioural therapy (CBT) should now be offered to everyone with psychosis in the UK. This has rightly resulted in an increased demand for adherent therapy from qualified clinicians. Individualised formulation is a key component of CBT for psychosis, yet many trainees struggle to make sense of and apply the theoretical models on which these are based. This study explored trainee and recently qualified therapists’ experience of formulating CBT for psychosis, to help us understand how best to guide training and clinical practice. We ran focus groups with trainees who were completing, or had recently completed, postgraduate training in CBT for psychosis. We then analysed verbatim transcripts of the semi-structured interviews. and completed a thematic analysis of the data using inductive open coding. Three over-arching themes were generated: (1) purpose of formulation, (2) formulation in practice, and (3) (reflection on) learning to formulate. Training programmes and clinical supervisors should focus on fostering trainees’ and newly qualified therapists’ ability to develop simple, targeted formulations. These will draw on maintenance and developmental models of psychosis, depending on the person’s needs and goals. Opportunities for procedural learning are likely to improve skilful formulation, and use as the basis for therapeutic change.Key learning aims(1)CBT for psychosis is best guided by individualised formulation.(2)The range and complexity of current theoretical models is challenging.(3)A qualitative analysis of trainee and recently qualified therapists’ experiences highlights means of facilitating understanding and application of these models.

POSC276 Pharmacoeconomic Evaluation Criteria for Highly Specialised Technologies, and Subsequent Recommendations: A Comparison of NICE UK and the NCPE Ireland

With accelerating emergence of the NICE classification of Highly Specialised Technologies (HST), appropriate pharmacoeconomic evaluation is imperative to ensuring timely patient access in areas of high unmet need. NICE guidance outlines several criteria by which to evaluate HST for very rare diseases, where the NCPE follow a broader guideline for evaluation of all types of Health Technology Assessments (HTA). The objective of the analysis is to delineate trends in evaluations by NICE and the NCPE, and subsequent reimbursement outcomes.

POSA315 A Computationally Efficient Alternative Method for Probabilistic One-Way Sensitivity Analysis

McCabe (2020) proposed probabilistic one-way sensitivity analysis (POSA) to replace traditional one-way sensitivity analysis (OWSA). The POSA approach is also considered for the NICE guidance update as it incorporates the whole distribution of uncertain parameters, not only , and better reflects the uncertainty of cost-effectiveness outcomes than deterministic sensitivity analysis. POSA is implemented by fixing each uncertain parameter to selected quantiles one-by-one, and running a traditional probabilistic sensitivity analysis (PSA) on all other parameters.

P-BN47 Acute cholecystectomy in elderly - Age is not a limit

Abstract Background Acute or hot cholecystectomy (AC) has been established as a safe and efficacious modality of managing acute biliary pathology. However, it has been performed with caution in the elderly (defined by the world health organisation as patients over the age of 65). The NICE guidance in this area does not preclude this practise on elderly patients. Our acute cholecystectomy service treats patients of all ages according to performance status and fitness for surgery rather than age we audited our results in this age group. Methods All patients over the age of 65 who underwent acute cholecystectomy in the dedicated emergency cholecystectomy lists were audited from the period starting 31st December 2019 to 31st June 2021. Patient demographics, co-morbidies and surgical factors were recorded. The primary outcomes measure was in hospital stay and re-admission, secondary outcome were complications and perioperative mortality. Results 41 elderly patients underwent AC during the audit period, (male 18: female 23). Majority of patients had acute cholecystitis 30(73%). The median inpatient stay following surgery was 2 days(range 2-5 days) and the median admission to surgery time was 6 days (range 5-12 days). Only 3(7%) patients had a subtotal cholecystectomy. There was only 3 complications from surgery which were all between a clavien-dindo score of 2 and 3. There were 3 readmission in the immediate post-operative period. There was one 30-day mortality which was from necrotising pancreatitis as a result of ERCP and not from the operation. Conclusions Acute cholecystectomy in this age group appears to be safe and effective way to treat acute biliary pathology and compares similarly to the outcomes in the younger groups.

O-P02 A fast-track surgery programme leads to timelier treatment and higher resection rates in pancreatic cancer

Abstract Background Pancreatic cancer is currently the fourth most common cause of cancer-related mortality in the economically developed world and is set to become the second most common cause of cancer-related mortality within the next few years. NICE guidance makes a strong recommendation to offer up-front surgery to people with resectable pancreatic cancer, without preoperative biliary drainage, if sufficiently fit for surgery. The aim of this study was to perform a propensity-matched comparison of patients with pancreatic cancer undergoing surgery, with and without biliary stenting, to examine perioperative outcomes and to perform an intention to treat analysis to evaluate long-term survival between the two groups. Methods This was an observational study of a cohort of consecutive patients presenting with obstructive jaundice and undergoing pancreatoduodenectomy for pancreatic and periampullary malignancies between November 2015 and May 2019. Data related to patient and tumour characteristics, biliary drainage, surgery and histopathology were gathered and analysed from a prospectively maintained electronic database. Post-operative complications were defined and graded according to the definitions of the International Study Group on Pancreatic Surgery (ISGPS) and the Clavien-Dindo system. Data related to adjuvant treatment, disease recurrence and overall survival were also analysed. Results In this retrospective study of 216 consecutive operable patients, 70 followed the fast-track (FT) pathway and 146 had pre-operative biliary drainage (PBD). All 70 patients in the fast-track group and 122 out of 146 in the PBD group proceeded to surgery (100% and 83.6% respectively, p = 0.001). Interval time from diagnostic CT scan to surgery and from MDT decision to treat to surgery was much shorter in the FT group (median range) 8 vs 43 days p &amp;lt; 0.001 and 3 vs 36 days p &amp;lt; 0.001 respectively) as was the overall time from diagnostic CT to adjuvant treatment (88 vs 121 days p &amp;lt; 0.001). Postoperative outcomes including in-hospital stay, number and grading of complications, readmission rate and mortality rates were comparable in the two groups. There was no difference in survival between the two groups. Conclusions These data strengthen the existing evidence that, for a person with pancreatic cancer who is proceeding to surgery, the best approach is to avoid pre-operative biliary drainage. The optimal comparison to the neoadjuvant approach is upfront fast-track surgery without biliary drainage followed by adjuvant therapy.

Vitamin D status of critically ill patients with Covid-19

Rationale: Vitamin D may enhance the immune response against respiratory viruses. Vitamin D treatment might decrease the incidence of viral respiratory tract infections in patients with vitamin D deficiency(1). NICE guidance(2) concluded further research is required to confirm the impact of vitamin D on COVID-19 and studies are currently in progress. It is not common practice to test vitamin D status on admission to intensive care units (ICU). We sought to determine the vitamin D status of acutely severe respiratory failure patients presenting with COVID-19 in a large tertiary ICU in the UK.

Establishing frailty and falls risk assessment screening in an MSK outpatient physiotherapy department

Purpose: To implement frailty and falls risk assessment screening as a core part of patient assessments following Trust objectives, NICE guidance and the NHS 10 year plan objective of helping people to age well, enabling us to identify those at risk and signpost to services appropriately.

CTNI-30. A SNAPSHOT OF “REAL WORLD” CURRENT NEURO-ONCOLOGY PRACTICE IN TEN UK CENTRES AND RATIONALE FOR THE TESSA JOWELL BRAIN MATRIX (TJBM) PLATFORM STUDY

Abstract OVERVIEW The TJBM Platform Study (https://www.birmingham.ac.uk/research/crctu/trials/brain-matrix) is a programme of work aimed at improving the knowledge of, and treatment for, glioma. We present the feasibility data collected from the initial ten UK centres. METHOD The UK TJBM centres completed a multi-disciplinary feasibility questionnaire to facilitate participation and collaboration across centres. Data were collected from hospital electronic board review records, clinic letters, operative and imaging notes, MDT or personal experience. RESULTS Work load: Between 2016-2018 service provision redistribution reflects a trend towards higher volume centres. Overall, glioma workload within ten TJBM centres has remained stable. Imaging: All TJBM centres have good access to imaging techniques and neuroradiology expertise, including relevant ‘advanced’ imaging. All have RANO capability, although not widely used clinically. Neurosurgery: All centres have access to 5 ALA, perform awake craniotomy for language assessment and motor/sensory mapping are typically performed asleep, with subtle variation in techniques. Pathology: Despite molecular analysis advances, current practice is limited to the evaluation of formalin embedded tissue by traditional morphology/ immunohistochemically staining, with limited targeted testing of specific genetic changes. Clinical oncology: Oncology treatments for glioma were as per NICE guidance with some minor local variation. A relative lack of linking treatments to detailed clinical, treatment, toxicity, and quality of life data making communication of significance of findings to patients challenging. CONCLUSION Through systematic real-world data collection the TJBM platform study will provide a detailed understanding of practice within the UK, linked to molecular tumour genotype, treatment response outcome measures, and regular quality of life assessments. This infrastructure will help establish a trial-competent network for future collaborative research. Academic and industry partners will be able to use the TJBM platform through collaboration, overseen by a strong governance framework. This will maximise the opportunities and abilities to translate advances into trials and patient benefit.

EP.TH.917An Audit of Compliance with NICE guidelines for Acute Cholecystitis

Abstract Background Gallstone disease is common and affects approximately 10-15% of adults. Laparoscopic Cholecystectomy (LC) is the definitive management of cholecystitis. NICE and RCS guidance recommend that in patients diagnosed with acute cholecystitis a LC should be performed during the same admission or within 7 days. We audited our compliance against these national guidelines. Methods Retrospective audit of all patients admitted with uncomplicated acute cholecystitis over a 4 month period. Patient demographics, admission details, timing of cholecystectomy, complications, follow-up, and re-admission data were collected. Results 50 patients (60% female, 40% male; mean age: 60.7 years) with acute cholecystitis were included. Mean length of stay was 4.8 days. Only 10% had a cholecystectomy within 1 week of diagnosis. Of those discharged without a LC on the index admission, 14% were readmitted with further gallstone related complications (cholangitis, pancreatitis) within 48.6 days from initial discharge. The mean time to surgery after initial discharge was 125.8 days. Conclusion There is poor compliance with NICE guidelines to perform an early LC in our cohort of patients, primarily because of the lack of Trust based guidelines. This audit demonstrates the need to develop a robust ‘hot gallbladder’ pathway within our hospital to improve current practice.

EP.FRI.1012 One plus one equals four: how NELA inspired a quality improvement programme that produced 4 distinct positive outcomes

Abstract Aim To describe how NELA inspired an ‘improving emergency surgery’ quality improvement programme that produced improvements in 4 distinct areas of surgical practice. Methods This paper describes how Kotter's improvement methodology was implemented in a district general hospital to achieve NELA targets, reduce the negative appendicectomy rate in children, implement NICE guidance on early laparoscopic cholecystectomy for acute cholecystitis and consistently deliver the 'S' and 'A' of SAFER within the surgery department. Results As a result of a systematic quality improvement approach, Conclusions Incorporating NELA into a local 'improving emergency surgery' quality improvement programme has delivered important and wide-ranging benefits beyond emergency laparotomy, and protected the service from 'crowding out behaviour' where focus on a single quality improvement can come at the expense of quality in other areas.

SP6.1.1 Cholecystectomy or expectant management after endoscopic sphincterotomy and bile duct stone removal?

Abstract Aims Following ERCP, NICE guidance suggests that surgically fit patients undergo cholecystectomy to prevent recurrence of choledocholithiasis and its complications. However, for many patients who are deemed unfit or who choose not to have surgery, ERCP is their definitive management. This study examines the clinical outcomes and costs of expectant management (EM) or cholecystectomy following ERCP. Methods All patients that underwent ERCP, sphincterotomy and common bile duct (CBD) clearance at St James’s University Hospital between January 2015 and December 2018 were identified from a prospectively maintained ERCP database. The clinical outcomes for patients that had undergone an ERCP, sphincterotomy and CBD clearance for gallstones were identified from their electronic patient record. A cost analysis for the complete patient pathway was performed. Results 820 patients underwent ERCP and CBD clearance for gallstones with a median 3.9 year follow up. 222 patients had undergone a cholecystectomy prior to ERCP and were excluded from analysis. 203 patients underwent planned cholecystectomy with 15% (31 patients) requiring complex surgery and 12% (24 patients) needing readmission. 395 patients received expectant management (EM). 9 (2.3%) patients returned with CBD stone symptoms, 6 (1.5%) went on to laparoscopic cholecystectomy (LC). The readmission rate in the EM group was 9%. The average cost per patient in the expectant management group was £7,487 and in the cholecystectomy group was £10,584. Conclusion The results from this study suggest that the need for cholecystectomy following ERCP is uncertain, with similar rates of biliary re-admissions in both groups.

EP.WE.802Are we over-zealous in our management of acute diverticulitis?

AimsOf the 25% of people with diverticula who develop symptomatic diverticular disease, approximately 75% will have at least one episode of diverticulitis. However according to the latest NICE guidance those with diverticulitis who are not systemically unwell may not require either admission or antibiotics. In the financially austere environment facing the NHS within the COVID 19 pandemic, prudence in such resource allocation is of vital importance. We aim to review management of patients with acute diverticulitis over a 6-month period in a district general hospital against the 2019 NICE guidelines.Methods29 patients presenting with acute diverticulitis, M:F ratio 12:17, median age 55 (range 24-82), median ASA 2 (range 0-3) were retrospectively reviewed. Biochemical markers, lactate and vital signs were used to assess if attending patients were systemically unwell.Results23 patients were admitted and 6 managed as outpatients via the surgical ambulatory unit. Of the 29 patient cohort, 9 (31%) were systemically unwell. All 9 unwell patients received antibiotics. Of the 20 patients not considered systemically unwell, 11 (55%) received antibiotics. 16 (80%) that were admitted did not require admission on retrospective review.ConclusionPrompt administration of intravenous antibiotics for septic patients with diverticulitis reduces associated morbidity and mortality and the observed adherence to this principle is encouraging. For systemically well patients, increased clinical discernment is required to consider managing patients in the surgical ambulatory setting, avoiding unnecessary admissions. Similar caution must be used in appropriate use of antimicrobials to avoid unnecessary adverse consequences.