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The National Institute for Health and Care Excellence (NICE) invited the manufacturer (Kyowa Kirin) of mogamulizumab (Poteligeo(R)), as part of the single technology appraisal process, to submit evidence for its clinical and cost-effectiveness for previously treated mycosis fungoides (MF) and Sezary syndrome (SS). Kleijnen Systematic Reviews Ltd, in collaboration with Maastricht University Medical Centre, was commissioned to act as the independent evidence review group (ERG). This paper summarises the company submission (CS), presents the ERG's critical review of the clinical and cost-effectiveness evidence in the CS, highlights the key methodological considerations and describes the development of the NICE guidance by the Appraisal Committee. Based on a systematic literature review, one randomised controlled trial, MAVORIC, was identified showing favourable results in patients with MF and SS. However, MAVORIC compared mogamulizumab to vorinostat, which is not standard care in the NHS, and there is uncertainty due to the study design, specifically crossover of patients. Based on a "naive comparison of results from the vorinostat arm of the MAVORIC study and the physician's choice arm (methotrexate or bexarotene i.e. United Kingdom [UK] standard treatments) of the ALCANZA study as well as comparison to Phase II bexarotene data", the company considered vorinostat to be "a reasonable proxy for current standard of care in the NHS". The ERG considered, based on the limited data available, that the comparability of vorinostat (MAVORIC) and physician's choice (ALCANZA) could not be established. In response to the Appraisal Consultation Document, the company provided an unanchored matched adjusted indirect comparison (MAIC) of mogamulizumab with UK standard care by analysing Hospital Episode Statistics (HES) data. However, given the high risk of bias of an unanchored MAIC, these results needed to be regarded with a considerable degree of caution. The economic analysis suffered from uncertainty because there was no trial evidence on the comparator in the England and Wales National Health Service (NHS), and it was unclear to what extent the trial (MAVORIC) comparator (vorinostat) was comparable to standard care, referred to as established clinical management (ECM) in the NHS. The evidence for overall survival had not reached maturity and was confounded by treatment switching, for which different crossover adjustment methods produced large variations in life years. Caregiver utilities were applied in the analysis, but there was a lack of guidance on their application and whether these were indicated in this appraisal. After consultation, the company updated the economic analysis with the MAIC. Incremental cost-effectiveness ratios comparing mogamulizumab against ECM were (depending on whether the HES or MAVORIC comparison were used) 31,030 pound or 32,634 pound per quality-adjusted life years (QALYs) gained according to the company's base case and 38,274 pound or 80,555 pound per QALY gained according to the ERG's base case. NICE did not recommend mogamulizumab for treating MF or SS in adults who have had at least one previous systemic treatment.

Background Although there is high-level evidence supporting positive perinatal outcomes for midwifery group practice (MGP) care, not all women can access this model due to a failure to implement or sustain it. The way that MGPs are managed could be an important factor in whether they are successful in the long-term. Aim To explore what determines optimal management of MGP in Australia, and the influence it has on sustainability of MGP. Methods Interviews were conducted with MGP midwives (n = 8). Transcriptions of the audio recordings were analysed thematically and lexically for triangulation. Findings Following a thematic analysis of the data, an over-arching theme emerged – namely — being valued and supported, with three sub-themes: a nice little sweet spot, someone to stand up for you, and building relationships and support beyond the model. This revealed that value and support by all stakeholders, including the midwives themselves, was necessary to sustain an MGP. The lexical analysis revealed the themes: support, the system, and the caseload. This analysis highlighted the importance of the system – specifically, the impact of the institution on how MGP is operationalised. Conclusion For MGP to be sustained in Australia, it needs to be prioritised, nurtured, and embraced by the whole maternity care system. Management plays an important role in ensuring the right people are employed to pivotal positions and that midwifery-led models of care are valued and supported throughout the system.

Introduction We assessed the practice of surgeons regarding venous thromboembolism (VTE) chemical prophylaxis for total hip replacement (THR) and total knee replacement (TKR), before and after issuing of updated National Institute for Health and Care Excellence (NICE) guidance in 2018. Methods A survey, circulated through the British Hip Society and regional trainee networks/collaboratives, was completed by 306 UK surgeons at 187 units. VTE chemical prophylaxis prescribing patterns for surgeons carrying out primary THR (n=258) and TKR (n=253) in low-risk patients was assessed after publication of 2018 NICE recommendations. Prescribing patterns before and after the NICE publication were subsequently explored. Results Following the new guidance, 34% (n=87) used low-molecular-weight heparin (LMWH) alone, 33% (n=85) aspirin (commonly preceded by LMWH) and 31% (n=81) direct oral anticoagulants (DOACs: with/without preceding LMWH) for THR. For TKR, 42% (n=105) used aspirin (usually monotherapy), 31% (n=78) LMWH alone and 27% (n=68) DOAC (with/without preceding LMWH). NICE guidance changed the practice of 34% of hip surgeons and 41% of knee surgeons, with significantly increased use of aspirin preceded by LMWH for THR (before=25% vs after=73%; pConclusion Over one-third of surveyed surgeons changed their VTE chemical prophylaxis in response to 2018 NICE recommendations, with more THR and TKR surgeons now compliant with latest NICE guidance. The major change in practice was an increased use of aspirin for VTE chemical prophylaxis.

Objectives To examine outcome for hip fracture patients treated by a hemiarthroplasty (HA) but who actually met the United Kingdom, National Institute for Health and Care Excellence (NICE) criteria for receiving a total hip arthroplasty (THA). Design Match Cohort Study. Setting Level 1, Academic Trauma Centre (UK Major Trauma Centre)Patients/Participants: 398 patients underwent either a HA or THA for a non-pathological displaced intra-capsular fractured neck of femur (OTA/AO 31 B3 (garden 3-4), having met the NICE criteria for THA. Intervention HA versus THA. Two analyses were performed, the first comparing the outcome in a cohort of patients who either received a THA or HA, but who all had met the NICE criteria to receive a THA (n=398). The second analysis assessed the outcome of THA versus HA, in a matched cohort of patients who all met the NICE criteria for a THA (n=44 matched pairs). All patients in the matched cohort were able to walk independently outdoors (WIO) prior to injury. Main outcome Mobility and functional outcome, one year following surgery. Results Of the 398 patients who met the criteria for THA, only 78 (19.6%) patients actually received a THA. Within the matched cohort, significantly more THA patients (92.9%, 39/42) maintained the ability to walk independently outdoors at 1-year compared to HA patients (56.4%. 22/39; p=0.001). There was no difference in mortality, re-operation or complication rates for our matched population at 1 year. Conclusion Patients who meet the NICE criteria for THA and are able to walk independently outdoors pre-injury are more likely to have a higher level of independent mobility and a better functional outcome at 1-year if they receive a THA, as opposed to receiving a HA. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Objectives This study aimed to compare the current 5 investigation strategies to defer cardiac testing in patients with stable chest pain. Background For the clinical management of stable chest pain, the identification of patients unlikely to benefit from further cardiac testing is important, but the most appropriate investigation strategy is unknown. Methods A total of 4,207 patients referred to coronary computed tomography angiography for stable chest pain were classified into low- and high-risk groups according to the 2016 National Institute of Health and Care Excellence (NICE) guideline-determined strategy; PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) minimal risk tool–based strategy; 2019 European Society of Cardiology (ESC) guideline–determined strategy; and coronary artery calcium score (CACS), either in isolation (the CACS strategy) or as part of a weighted clinical likelihood model–based strategy (the CACS-CL strategy). The associations of obstructive coronary artery disease on coronary computed tomography angiography, major adverse cardiovascular events, and subsequent clinical management with risk groups according to different strategies were evaluated and compared. Results The NICE, PROMISE, ESC, CACS, and CACS-CL strategies classified a proportion (22.63%, 29.21%, 41.84%, 46.76%, and 51.41%, respectively) of patients into low-risk groups. Compared with the NICE, PROMISE, ESC, and CACS strategies, the CACS-CL strategy had a stronger association between risk groups and obstructive coronary artery disease (odd ratios: 16.00 vs 2.93, 5.53, 7.94, and 10.39, respectively), major adverse cardiovascular events (HRs: 6.83 vs 1.90, 2.94, 4.23, and 5.13, respectively) and intensive subsequent clinical management as well as better metrics of diagnostic accuracy and positive net reclassification improvement. Conclusions Among contemporary strategies used to identify patients with stable chest pain at low risk, the use of CACS, especially when combined with clinical risk features, showed the strongest potential to effectively defer cardiac testing.

Background This is the 2nd update to the 9th edition of these guidelines. We provide recommendations on 17 PICO (Population, Intervention, Comparator, Outcome) questions, four of which have not been addressed previously. Methods We generate strong and weak recommendations based on high-, moderate-, and low-certainty evidence, using GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology. Results The panel generated 29 guidance statements, 13 of which are graded as strong recommendations, covering aspects of antithrombotic management of VTE from initial management through secondary prevention and risk reduction of postthrombotic syndrome. Four new guidance statements have been added that did not appear in the 9th edition (2012) or 1st update (2016). Eight statements have been substantially modified from the 1st update. Conclusion New evidence has emerged since 2016 that further informs the standard of care for patients with VTE. Substantial uncertainty remains regarding important management questions, particularly in limited disease and special patient populations.

Aims Evaluate whether UK National Institute for Health & Care Excellence (NICE) chronic heart failure (HF) guidelines can be safely and effectively refined through specialist referral management. Methods and results All referrals to a UK centre 1/3/2019–30/5/2019 and 1/6/2020–31/7/2020 were reviewed by HF specialists. Patients were triaged to specialist assessment in HF clinic, according to the NICE HF diagnostic pathway [urgency based on N‐terminal pro brain natriuretic peptide (NTproBNP) levels], or the referrer given remote Advice & Guidance (A&G), to aid primary care management. Standardized triage criteria for recommending primary care management were (i) presentation inconsistent with HF, (ii) competing comorbidity/frailty meant specialist assessment in clinic not in patient's best interests, (iii) recent assessment for same condition, or (iv) patient had known HF. Following triage patients managed in the primary care were categorized as low or high risk of adverse outcomes. Outcome measures were 90 day all‐cause and HF hospital admission and mortality rates. Four hundred and eighty‐six patients had the median age of 80 (74–86) years, and 253 (52%) were male. Two hundred and six (42%) had NTproBNP > 2000 pg/mL. Primary care management was recommended for 128 patients (26%): 105 (22%) A&G alone and 23 input from community HF nurse specialists. Primary care management was recommended due to the following: presentation inconsistent with HF 53 (42%), more important competing comorbidity/frailty 35 (27%), recent assessment 17 (13%), and known HF 23 (18%). Patients managed in primary care had higher rates of all‐cause hospitalization (30% vs. 19%; P = 0.018) and death (7% vs. 2%; P = 0.0054) than those seen in HF clinic. Of those managed in primary care, 50 (39%) were determined to be at low risk and 78 (61%) at high risk. High‐risk patients were older (87 vs. 80 years; P = 0.0026), had much higher NTproBNP (2666 vs. 697 pg/mL; P

Background Young people need equitable access to high-quality sexual and reproductive health care to enjoy good sexual health. Methods This online survey of people aged 15–24 years in a defined region of New Zealand asked about unmet need for sexual health care and sought views on improving access to sexual health care. Results Five hundred participants took part in the study between August and October 2020, of whom 60% were female, 25% were of Māori (indigenous) ethnicity, and 21.4% were gender and/or sexuality diverse. Sixty percent had ever received sexual health care (300/500), and 74.3% received it from a general practice clinic (223/300). Overall, 41% (204/500) reported they needed, but had not received sexual health care in the past (‘unmet need’). Reasons for unmet need included being shy, embarrassed or ashamed (74.5%, 152/204), fear of judgment by clinic staff (42.6%, 87/204), cost (32.8%, 67/204), concerns about confidentiality (28.9%, 59/204), and not knowing where to go (24%, 49/204). Māori participants were more likely to report not knowing where to go (32.1% vs 20%, P = 0.04). Participants identified the need to reduce stigma, normalise sexual health care, improve convenience, affordability and awareness of services as key to improving access. Reassurance about confidentiality and being treated with kindness, empathy and respect were deemed critical to service acceptability. Conclusions Action is urgently needed at policy, funding and practice levels to improve access to services by: reducing societal stigma, normalising discussions around sexual health, improving affordability and raising awareness of services. Quality improvement is also needed in general practice to ensure young people can routinely access youth-friendly sexual and reproductive health care.

Aims Current National Institute for Health and Clinical Excellence (NICE) guidance advises that MRI direct from the emergency department (ED) should be considered for suspected scaphoid fractures. This study reports the current management of suspected scaphoid fractures in the UK and assesses adherence with NICE guidance. Methods This national cross-sectional study was carried out at 87 NHS centres in the UK involving 122 EDs and 184 minor injuries units (MIUs). The primary outcome was availability of MRI imaging direct from the ED. We also report the specifics of patient management pathways for suspected scaphoid fractures in EDs, MIUs, and orthopaedic services. Overall, 62 of 87 centres (71%) had a guideline for the management of suspected scaphoid fractures. Results A total of 11 of 87 centres (13%) had MRI directly available from the ED. Overall, 14 centres (17%) used cross-sectional imaging direct from the ED: MRI in 11 (13%), CT in three (3%), and a mixture of MRI/CT in one (1%). Four centres (6%) used cross-sectional imaging direct from the MIU: MRI in three (4%) and CT in two (2%). Of 87 centres’ orthopaedic specialist services, 74 (85%) obtained repeat radiographs, while the most common form of definitive imaging used was MRI in 55 (63%), CT in 16 (19%), mixture of MRI/CT in three (3%), and radiographs in 11 (13%). Conclusion Only a small minority of centres currently offer MRI directly from the ED for patients with a suspected scaphoid fracture. Further research is needed to investigate the facilitators and barriers to the implementation of NICE guidance. Cite this article: Bone Jt Open 2021;2(11):997–1003.

Copyright © 2021 The Author(s). Aim: To evaluate the cost-effectiveness of [177Lu]Lu-DOTA-TATE versus relevant comparators for the treatment of neuroendocrine tumours located in the gastrointestinal tract (GI-NETs) and the pancreas (P-NETs). Materials and methods: A three-state partitioned survival model was developed to perform a cost-utility analysis of [177Lu]Lu-DOTA-TATE versus standard of care (high dose Octreotide LAR), everolimus and sunitinib. Effectiveness data for SoC, everolimus and sunitinib were obtained from published Kaplan–Meier survival curves. Given a lack of head-to-head effectiveness data, matching adjusted indirect comparisons (MAICs) were performed to population-adjust [177Lu]Lu-DOTA-TATE survival data based on prognostic factors and derive estimates of relative effectiveness. Health state utilities were estimated from real-world evidence. Drug acquisition costs were taken from nationally published sources (BNF, NICE), and administration costs were based on treatment protocols in [177Lu]Lu-DOTA-TATE studies, combined with nationally published unit costs (PSSRU, DoH reference costs). Incidence of adverse events were estimated using published sources. A discount rate of 3.5% was applied to both utilities and costs, and deterministic and probabilistic sensitivity analyses were performed. Costs were included from an NHS perspective and presented in 2017/18 GBP (and PPP Euros for base case). Results: In GI-NETs, the incremental cost-effectiveness ratio (ICER) of [177Lu]Lu-DOTA-TATE compared to SoC and everolimus was £26,528 (€27,672) and £24,145 (€25,186) per QALY, respectively. In P-NETs, the ICER of [177Lu]Lu-DOTA-TATE compared to SoC was £22,146 (€23,101) or £28,038 (€29,251) dependent on matched population, and £21,827 (€22,766) and £15,768 (€16,445) compared to everolimus and sunitinib, respectively. Conclusions: At a willingness to pay threshold of £30,000, [177Lu]Lu-DOTA-TATE is likely to be a cost-effective treatment option for GI-NET and P-NET patients versus relevant treatment comparators (NHS perspective). Advanced Accelerator Applications (AAA), a Novartis company.

Aims: To explore health technology assessment (HTA) outcomes of matched drug pairs by national agencies in Germany (Gemeinsamer Bundesausschuss, GBA), France (Haute Autorité de Santé, HAS) and England and Wales (NICE). Methods: We considered published GBA decisions, HAS reports and NICE guidance from January 2011 to June 2018. HTAs of matched pairs were compared overall, and for non-cancer and cancer drugs separately. We further analyzed the role of additional attributes related to cancer therapies. Results: Matched pairs show higher concordance for GBA/HAS than for GBA/NICE and HAS/NICE. Overall, NICE evaluated technologies more favorably than GBA and HAS. GBA appraisals of cancer drugs, however, tended to be more positive than cancer-related recommendations by NICE and HAS. Conclusion: The findings indicate substantial variations in HTAs, although cancer-related outcomes seem to diverge less than non-cancer results.

OBJECTIVES: Challenges with patient-reported outcome (PRO) evidence and health state utility values (HSUVs) in rare diseases exist due to small, heterogeneous populations, lack of disease knowledge and early onset. To better incorporate quality of life (QoL) into Health Technology Assessment, a clearer understanding of these challenges is needed.METHODS: NICE appraisals of non-oncology treatments with an EMA orphan designation (n = 24), and corresponding appraisals in the Netherlands, France, and Germany were included. Document analysis of appraisal reports investigated how PROs/HSUVs influenced decision-making and was representative of QoL impact of condition and treatment.RESULTS: PRO evidence was not included in 6/24 NICE appraisals. When included, it either failed to demonstrate change, capture domains important for patients, or was uncertain. In the other countries, little information was reported and evidence largely did not demonstrate change. In NICE appraisals, HSUVs were derived through the collection of EQ-5D data (7/24 cases), mapping (6/24), vignettes (5/24), and published literature or other techniques (6/24). The majority did not use data collected alongside clinical trials. Few measures demonstrated significant change due to lack of sensitivity or face validity, short-term data, or implausible health states. In 8/24 NICE appraisals, patient surveys or input during appraisal committee meetings supported the interpretation of uncertainty or provided evidence about QoL.CONCLUSIONS: This study sheds light on the nature of PRO evidence in rare diseases and associated challenges. Results emphasise the need for improved development and use of PRO/HSUVs. Other forms of evidence and expert input are crucial to support better appraisal of uncertain or missing evidence.

Heart failure (HF) with reduced ejection fraction (HFrEF) is a global cause of morbidity and mortality with over 60 million estimated cases worldwide. The burden of HF care is expected to increase with an ageing population as evidenced by the fact that 80% of HF-related hospitalizations occur in those aged above 65. Given the significant morbidity and mortality associated with HFrEF, there is a need for new prognostic therapies that have an impact on morbidity and mortality. In February of 2021, the National institute for Health and Care Excellence (NICE) released new guidance on the utility of Dapagliflozin for the management of heart failure with reduced ejection fraction (HFrEF). NICE advocated that dapagliflozin is a viable treatment option in symptomatic HFrEF patients on optimal medical management. The current list price of dapagliflozin is around £36.59 per 28-tablet pack with an estimated annual cost of £476.98 equating to £6939 per quality-adjusted life year. The guidance was mainly based on evidence produced from the 2019 DAPA-HF trial. This demonstrated that in HFrEF population, the use of dapagliflozin led to a significant reduction in worsening HF events, cardiovascular, and all-cause death. In this article, we summarize the evidence base for sodium-glucose co-transporter-2 inhibitors in the non-diabetic heart failure patient.

Although histories of cognitive behaviour therapy have begun to appear, their use with people with psychosis diagnoses has received relatively little attention. In this article, we elucidate the conditions of possibility for the emergence of cognitive behaviour therapy for psychosis (CBTp) in England between 1982 and 2002. We present an analysis of policy documents, research publications and books, participant observation, and interviews with a group of leading researchers and senior policy actors. Informed by Derksen and Beaulieu’s articulation of social technologies, we show how CBTp was developed and stabilised through the work of a variety of overlapping informal, academic, clinical, professional, and policy networks. The profession of clinical psychology played a key role in this development, successfully challenging the traditional ‘division of labour’ where psychologists focused on ‘neurosis’ and left ‘psychosis’ to psychiatry. Following Abbott's systems approach to professions, we identify a number of historical factors that created a jurisdictional vulnerability for psychiatry while strengthening the jurisdictional legitimacy of clinical psychology in providing psychological therapies to service users with psychosis diagnoses. The National Institute for Health and Clinical Excellence played a significant role in adjudicating jurisdictional legitimacy, and its 2002 schizophrenia guidelines, recommending the use of psychological therapies, marked a radical departure from the psychiatric consensus. Our analysis may be of wider interest in its focus on social technologies in a context of jurisdictional contestation. We discuss the implications of our study for the field of mental health and for the relationship between clinical psychology and psychiatry.

BackgroundNon-ischemic cerebral enhancing (NICE) lesions are exceptionally rare following aneurysm endovascular therapy (EVT).ObjectiveTo investigate the presenting features and longitudinal follow-up of patients with NICE lesions following aneurysm EVT.MethodsPatients included in a retrospective national multicentre inception cohort were analysed. NICE lesions were defined, using MRI, as delayed onset punctate, nodular or annular foci enhancements with peri-lesion edema, distributed in the vascular territory of the aneurysm EVT, with no other confounding disease.ResultsFrom a pool of 58 815 aneurysm endovascular treatment procedures during the study sampling period (2006–2019), 21/37 centres identified 31 patients with 32 aneurysms of the anterior circulation who developed NICE lesions (mean age 45±10 years). Mean delay to diagnosis was 5±9 months, with onset occurring a month or less after the index EVT procedure in 10 out of 31 patients (32%). NICE lesions were symptomatic at time of onset in 23 of 31 patients (74%). After a mean follow-up of 25±26 months, 25 patients (81%) were asymptomatic or minimally symptomatic without disability (modified Rankin Scale (mRS) score 0–1) at last follow-up while 4 (13%) presented with mild disability (mRS score 2). Clinical follow-up data were unavailable for two patients. Follow-up MRI (available in 27 patients; mean time interval after onset of 22±22 months) demonstrated persistent enhancement in 71% of cases.ConclusionsThe clinical spectrum of NICE lesions following aneurysm EVT therapy spans a wide range of neurological symptoms. Clinical course is most commonly benign, although persistent long-term enhancement is frequent.

ObjectiveTo report the performance of clinical practice guidelines (CPG) in the diagnosis of serious/invasive bacterial infections (SBI/IBI) in infants presenting with a fever to emergency care in the UK and Ireland. Two CPGs were from the National Institutes for Health and Care Excellence (NICE guidelines NG51 and NG143) and one was from the British Society for Antimicrobial Chemotherapy (BSAC).DesignRetrospective multicentre cohort study.PatientsFebrile infants aged 90 days or less attending between the 31 August 2018 to 1 September 2019.Main outcome measuresThe sensitivity, specificity and predictive values of CPGs in identifying SBI and IBI.SettingSix paediatric Emergency Departments in the UK/Ireland.Results555 participants were included in the analysis. The median age was 53 days (IQR 32 to 70), 447 (81%) underwent blood testing and 421 (76%) received parenteral antibiotics. There were five participants with bacterial meningitis (1%), seven with bacteraemia (1%) and 66 (12%) with urinary tract infections. The NICE NG51 CPG was the most sensitive: 1.00 (95% CI 0.95 to 1.00). This was significantly more sensitive than NICE NG143: 0.91 (95% CI 0.82 to 0.96, p=0.0233) and BSAC: 0.82 (95% 0.72 to 0.90, p=0.0005). NICE NG51 was the least specific 0.0 (95% CI 0.0 to 0.01), and this was significantly lower than the NICE NG143: 0.09 (95% CI 0.07 to 0.12, pConclusionNone of the studied CPGs demonstrated ideal performance characteristics. CPGs should be improved to guide initial clinical decision making.Trial registration numberNCT04196192.

Based on new trial data regarding immune checkpoint inhibitors (ICIs), the detection of high-grade microsatellite instability (MSI-H) or underlying deficient mismatch repair protein (dMMR) is now becoming increasingly important for predicting treatment response. For the first time, a PD‑1 ICI (pembrolizumab) has been approved by the European Medicines Agency (EMA) for first-line treatment of advanced (stage IV) dMMR/MSI‑H colorectal cancer (CRC). Further indications, such as dMMR/MSI‑H endometrial carcinoma (EC), have already succeeded (Dostarlimab, 2nd line treatment) and others are expected to follow before the end of 2021. The question of optimal testing in routine diagnostics should therefore be re-evaluated. Based on a consideration of the strengths and weaknesses of the widely available methods (immunohistochemistry and PCR), a test algorithm is proposed that allows quality assured, reliable, and cost-effective dMMR/MSI‑H testing. For CRC and EC, testing is therefore already possible at the primary diagnosis stage, in line with international recommendations (NICE, NCCN). The clinician is therefore enabled from the outset to consider not only the predictive but also the prognostic and predispositional implications of such a test when counseling patients and formulating treatment recommendations. As a basis for quality assurance, participation in interlaboratory comparisons and continuous documentation of results (e.g., QuIP Monitor) are strongly recommended.

Learning objectives Chest pain is a common presentation to the emergency department and can be caused by a range of conditions including acute myocardial infarction. However, only 1 in 10 patients with symptoms suggestive of acute coronary syndrome are ultimately diagnosed with myocardial infarction.1 As such, effective pathways are required to enable the prompt and safe rule-out of the majority of patients with non-cardiac presentations and the rapid identification of those with myocardial infarction. Recently published guidelines from the National Institute for Health and Care Excellence (NICE) and the European Society of Cardiology (ESC) have recommended the use of early rule-out pathways for myocardial infarction,2 3 enabled by the increased analytical precision of high-sensitivity cardiac troponin (hs-cTn) testing.4 These guideline recommendations are supported by recent randomised trials that have provided new insights into the safety and effectiveness of these pathways in clinical practice.5–7 Multiple pathways have been proposed that vary according to the thresholds used for decision-making and timing of sampling. Implementing a validated pathway could save healthcare resources and improve the safe delivery of patient care. Here we describe these early rule-out pathways, review their supporting evidence and provide practical advice for their adoption in clinical practice. Cardiac troponin is a highly specific marker of cardiomyocyte injury, which can be detected in the circulation within an hour of the onset of myocardial ischaemia.8 High-sensitivity assays have sufficient analytical precision to quantify very low concentrations of cardiac troponin in the majority of healthy people.9 The …

Post-COVID syndrome, or long COVID, is an increasing problem. Debbie Duncan looks at the evidence for management in primary care One in five people have symptoms that persist after 5 weeks, and one in ten have symptoms for 12 weeks or longer after an acute COVID-19 infection ( Office for National Statistics [ONS], 2020 ). NICE ( National Institute for Health and Care Excellence, 2020 ) defines this condition as post-COVID syndrome or long COVID. Common symptoms vary from fatigue, shortness of breath, palpitations, insomnia and anxiety and depression and encompasses a plethora of debilitating symptoms ( Dani et al, 2021 ). The new guideline for NICE (2021) recommends that patients presenting with new or ongoing symptoms 4 weeks or later after an initial COVID infection should have the investigations done to rule out acute, life-threatening complications or identify any unrelated diagnosis ( NICE, 2021 ). Garg et al (2020) suggests that long COVID is a multisystem syndrome and needs a multifaceted approach to tackle the physical, cognitive, psychological, social, and vocational aspects of this condition. This article looks at the literature about long COVID and suggests there is a clear pathway for treatment in primary care. All physicians should be equipped to recognise long-COVID and provide supportive management ( Dani et al, 2021 ).

Background It is not clear which method is more cost-effective: To initially provide all depressed patients with combination therapy (COMB; i.e. cognitive behavioural therapy plus pharmacotherapy), followed by antidepressant treatment (AD) for those still in depression; or, to first provide AD for all patients, followed by COMB for non-remission patients. The aim is to investigate whether a COMB-first strategy would be more cost-effective than an AD-first strategy, in treating depression. Methods A Markov model was developed to perform the analysis. The primary outcome was the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) at 104 weeks. Probabilistic sensitivity analysis and scenario analysis were performed, to investigate the uncertainty associated with the clinical parameters and the impact of CBT's cost on the results, respectively. Results The ICER per QALY at 104 week, was JPY 591,822 (USD 5,725) for moderate depression and JPY 499,487 (USD 4,832) for severe one. The scenario analysis revealed the ICER became JPY 1,147,518 (USD 11,101) for moderate and JPY 968,484 (USD 9,369) for severe when the CBT cost was set as JPY 14,400 (USD 139)(i.e. GBP 96: the unit cost of CBT in UK), which is well below the threshold recommended by NICE (i.e. GBP 20,000–30,000). Limitations This is a model-based analysis which was conducted from the health insurance perspective. Then, the analysis from the societal perspective would generate different results. Conclusions The results suggest that a COMB-first strategy would be more cost effective than an AD-first strategy.

Axial Spondyloarthritis (axial SpA) is an inflammatory arthritis primarily affecting the sacroiliac joints (SIJ) and spine and is a spectrum of disease which includes the more commonly known Ankylosing Spondylitis. Axial SpA is often missed in musculoskeletal assessments, and mismanaged and treated as chronic low back pain. Early diagnosis and intervention are essential to improve outcomes and so it is vital that people presenting with back pain are screened for axial SpA. This masterclass aims to improve clinicians’ understanding and awareness of axial SpA, including screening, recognition and when to refer to rheumatology. This article will familiarise clinicians with typical clinical features, appropriate investigation and interpretation, referral pathways in line with UK National Institute of Clinical Excellence (NICE) guidelines and advise on best practice for clinicians managing axial SpA.

Non-medicinal interventions (NMI) are recommended as a first-line treatment in gerontology in response to a behavioural disorder. The Thera Berce pilot study at the Nice University Hospital aims to determine whether the NMI corresponding to rocking in a comfort chair allows a reduction in disruptive behavioural disorders in people with neurocognitive disorders. Benefits and limitations.

BackgroundDue to fear and/or behaviour management problems, some children are unable to cooperate for dental treatment using local anaesthesia and psychological support alone. Sedation is required for these patients in order for dentists to be able to deliver high quality, pain-free dental care.The aim of this guideline is to evaluate the efficacy and relative efficacy of conscious sedation agents and dosages for behaviour management in paediatric dentistry and to provide guidance as to which sedative agents should be used.MethodsThese guidelines were developed using a multi-step approach adapted from that outlined by the National Institute for Clinical Excellence (NICE (2020) Developing NICE Guidelines: the manual.https://www.nice.org.uk/process/pmg20/chapter/introduction#main-stages-of-guideline-development. Accessed 7 Oct 2020). Evidence for this guideline was provided from a pre-existing Cochrane review (Ashley et al. Cochrane Database Syst Rev 12:CD003877, 2018) supplemented by an updated search and data extraction up to May 2020.ResultsStudies were from 18 different countries and had recruited 4131 participants overall with an average of 70 participants per study. Ages ranged from 0 to 16 years with an average age of 5.6 years across all included studies. A wide variety of drugs or combinations of drugs (n = 38) were used and delivered orally, intranasally, intravenously, rectally, intramuscularly, submucosally, transmucosally or by inhalation sedation. Twenty-four different outcome measures for behaviour were used. The wide range of drug combinations and outcome measures used greatly complicated description and analysis of the data.ConclusionOral midazolam is recommended for conscious dental sedation. Midazolam delivered via other methods or nitrous oxide/oxygen sedation could be considered, but the evidence for both was very low.

The National Institute for Health and Care Excellence (NICE) invited the manufacturer (Gilead) of filgotinib (Jyseleca(TM)), as part of the single technology appraisal process, to submit evidence for its clinical and cost effectiveness for the treatment of patients with moderate to severe rheumatoid arthritis (RA). Kleijnen Systematic Reviews Ltd, in collaboration with Maastricht University Medical Centre, was commissioned to act as the independent Evidence Review Group (ERG). This paper summarises the company submission (CS), presents the ERG's critical review of the clinical- and cost-effectiveness evidence in the CS, highlights the key methodological considerations, and describes the development of the NICE guidance by the NICE Appraisal Committee. The evidence for filgotinib was based on two good-quality international randomised controlled trials. In FINCH 1, filgotinib was compared with placebo, and in FINCH 2, filgotinib was compared with adalimumab and placebo. As there was no head-to-head evidence with most active comparators, the company performed two separate network meta-analyses (NMAs), one for the conventional disease-modifying antirheumatic drugs-inadequate response population and one for the biological disease-modifying antirheumatic drugs-inadequate response population. The outcomes analysed were American College of Rheumatology response criteria at weeks 12 and 24, and European League Against Rheumatism response criteria at 24 weeks. The statistical methods used to perform the NMAs were valid and were in line with previous NICE appraisals. Results of the NMAs are confidential and cannot be reported here, but they were uncertain due to heterogeneity of the included studies. The economic analysis of the patient population with moderate RA suffered from limited evidence on the progression from moderate to severe health states. For the moderate RA population, the final analyses comparing filgotinib, with or without methotrexate, against standard of care resulted in incremental cost-effectiveness ratios of around 20,000 pound per quality-adjusted life-year gained in the company's and ERG's base-case and scenario analyses. NICE recommended filgotinib in combination with methotrexate or as monotherapy when methotrexate is contraindicated, or if people cannot tolerate it, for patients with moderate RA whose disease had responded inadequately to two or more conventional disease-modifying antirheumatic drugs (DMARDs). For the severe RA population, in view of the higher or similar net health benefits that filgotinib provided versus its comparators, NICE recommended filgotinib with or without methotrexate for patients whose disease had responded inadequately to two or more conventional DMARDs, who had been treated with one or more biological DMARDs, if rituximab was not an option, or after treatment with rituximab.

Purpose The over-reliance on psychotropic medication for the management of patients with learning disabilities with behaviour that challenges is well documented.This paper aims to discuss the application of the methodology of clinical audit within community learning disability mental health services to adapt interventions including optimising prescribing practice and behavioural interventions aiming to reduce behaviour that challenges in people with learning disabilities. Design/methodology/approach Questionnaire-based review of documentation in electronic patient records, covering relevant audit standards in line with NICE and Royal College of Psychiatrists, was carried out in the North Essex Community Learning Disability Service, Hertfordshire Partnership NHS Foundation Trust. The audit included patients on the caseload of consultant psychiatrists. Findings The audit demonstrated that the prescribing of psychotropic medication was within BNF maximum limits for all patients, evidence of “consent” procedures was being followed in the majority, and there was some evidence of deprescribing attempts.Improvement was required in several areas e.g. undocumented off label prescribing in a significant proportion of patients. Objective measures to record the severity of behaviours and the effects of the medication were being used by clinicians in only a small proportion of patients. A significant proportion of patients have prescribed medication in the absence of appropriate psychological or environmental interventions. Originality/value As a result of the audit findings, the action plan made recommendations such as the development of a database for tracking the prescribing of psychotropic medicines and routine use of standardised measures. This action has been supported by the pharmacy team. Positive developments include a clinical psychologist taking on the role of leading the development of behavioural intervention strategies.

ObjectiveA diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) is recommended for irritable bowel syndrome (IBS), if general lifestyle and dietary advice fails. However, although the impact of a low FODMAP diet on individual IBS symptoms has been examined in some randomised controlled trials (RCTs), there has been no recent systematic assessment, and individual trials have studied numerous alternative or control interventions, meaning the best comparator is unclear. We performed a network meta-analysis addressing these uncertainties.DesignWe searched the medical literature through to 2 April 2021 to identify RCTs of a low FODMAP diet in IBS. Efficacy was judged using dichotomous assessment of improvement in global IBS symptoms or improvement in individual IBS symptoms, including abdominal pain, abdominal bloating or distension, and bowel habit. Data were pooled using a random effects model, with efficacy reported as pooled relative risks (RRs) with 95% CIs, and interventions ranked according to their P-score.ResultsWe identified 13 eligible RCTs (944 patients). Based on failure to achieve an improvement in global IBS symptoms, a low FODMAP diet ranked first vs habitual diet (RR of symptoms not improving=0.67; 95% CI 0.48 to 0.91, P-score=0.99), and was superior to all other interventions. Low FODMAP diet ranked first for abdominal pain severity, abdominal bloating or distension severity and bowel habit, although for the latter it was not superior to any other intervention. A low FODMAP diet was superior to British Dietetic Association (BDA)/National Institute for Health and Care Excellence (NICE) dietary advice for abdominal bloating or distension (RR=0.72; 95% CI 0.55 to 0.94). BDA/NICE dietary advice was not superior to any other intervention in any analysis.ConclusionIn a network analysis, low FODMAP diet ranked first for all endpoints studied. However, most trials were based in secondary or tertiary care and did not study effects of FODMAP reintroduction and personalisation on symptoms.

Introduction The externally validated Kidney Failure Risk Equation (KFRE) for predicting risk of end-stage renal disease (ESRD) has been developed, but its potential impact in a population on referrals for patients with chronic kidney disease (CKD) from primary to specialty nephrology care is not known. Methods A cross-sectional population-based study of individuals in United Kingdom primary care registered in The Health Improvement Network database was conducted. National Institute of Health and Care Excellence (NICE) 2014 CKD guidelines versus the 4-variable KFRE set at a >3% risk of ESRD at 5 years were applied to patients identified with CKD stage 3-5 between January 1, 2016, and March 31, 2017. Results In all, 39,476 (36.6%) of 107,962 adults with CKD stage 3-5 had a urine albumin:creatinine ratio (ACR) available and entered into the primary analysis. Of that, 7566 (19.2%) patients fulfilled NICE criteria for referral, 2386 (31.5%) of whom had a ≤3% 5-year risk of ESRD. Also 8663 (21.9%) patients had a >3% 5-year risk of ESRD, 3483 (40.2%) of whom did not fulfill NICE criteria; this represents 8.8% of the primary population. By using the KFRE threshold rather than NICE criteria for referral, 5869 patients (14.9% of the primary analysis population) would have been reallocated between primary and specialist care. Imputational analysis was used for missing ACR measurements and showed similar results. Conclusions A risk-based referral approach would lead to a substantial reallocation of patients between primary care and specialist nephrology care with only a small increase in numbers eligible, ensuring those at higher risk of progression are identified., Graphical abstract

Background The 6th World Symposium on Pulmonary Hypertension (Nice 2018) proposed a new definition of pre-capillary pulmonary hypertension (PH) as a condition with mean pulmonary artery pressure (mPAP) > 20 mmHg, pulmonary artery wedge pressure ≤ 15 mmHg, and pulmonary vascular resistance (PVR) ≥ 3 Wood units (WU). The characteristics and prognosis of patients with pre-capillary PH, according to this new definition, is unclear. Therefore, we determined the characteristics and survival of patients with borderline pre-capillary PH. Methods We retrospectively enrolled 683 patients who underwent their first right heart catheterization at Chiba University, Japan. Among them, 489 patients met the pre-capillary PH requirement with mPAP ≥ 25 mmHg (conventional pre-capillary PH group), while 22 patients met the borderline pre-capillary PH criteria (borderline pre-capillary PH group). Additionally, 16 patients with a mean PAP of 20–25 and PVR of 2–3 WU were also examined. Results The borderline pre-capillary PH group comprised 4.3% of the total patients with pre-capillary PH, and the majority was in Group 3 (40.9%) or 4 (45.5%). The survival of the borderline pre-capillary PH group tended to be better than that of the conventional pre-capillary PH group. The prognosis of Group3 PH was the worst among the patients with borderline precapillary PH. There was no significant difference in survival between the borderline pre-capillary PH group with PVR ≥ 3 WU and that with PVR of 2–3 2WU, although none of the patients in the latter group died due to right heart failure. Conclusions This is the first study conducted in a PH center in an Asian country to reveal the characteristics of patients with pre-capillary PH, according to the Nice 2018 definition. They comprised 4.3% of the total population with pre-capillary PH, and the majority of the pre-capillary PH cases were in either Group3 or 4. The prognosis may be affected by the patients’ underlying diseases. Further prospective studies are needed to determine whether the new definition, including the PVR cut-off, is beneficial in clinical practice.

Urinary incontinence (UI) is a bothersome symptom with population studies suggesting a prevalence of 13.1% in women and 5.4% in men. While a significant cohort of patients with this complaint may ultimately require surgical management to achieve complete continence, a number of non-surgical measures exist to improve symptoms and quality of life. A range of guidelines exist on this topic, including those published by the European Association of Urology (EAU), the International Continence Society (ICS), the American Urological Association (AUA) and the UK’s National Institute for Health and Care Excellence (NICE). The aim of our study is to provide an overview of the initial assessment of patients with UI including history taking, examination and basic investigations. Our review outlines non-surgical management strategies for UI, including conservative measures, behavioral and physical therapies and drug treatment. We shall also examine the above guidelines and present a narrative overview of the literature surrounding the diagnosis and non-surgical management of urinary incontinence.

Sinopsis Introducción: El 14,5% de los pacientes con cáncer desarrolla heridas neoplásicas malignas (HNM), caracterizadas como friables, exudativas, fétidas, sangrantes y dolorosas. Algunos estudios reportan que todos los pacientes con HNM experimentan dolor, pero hay escasez de evidencia científica para fundamentar su tratamiento. Objetivo: Mapear y examinar la evidencia existente sobre terapias tópicas para manejar el dolor en pacientes adultos con HNM. Método: Se diseñó un protocolo de revisión de alcance, de acuerdo con la metodología del Joanna Briggs Institute (JBI). Serán consultadas las bases de datos CINAHL, LILACS, Embase, Scopus, Web of Science, PubMed, Cochrane, NICE, Scopus, JBISRIR y la literatura gris, para la búsqueda de estudios publicados y no publicados en inglés, portugués y español. La selección estará a cargo de, al menos, dos revisores. La síntesis de los resultados será narrativa, con gráficos y tablas. Se incluirán estudios cualitativos, cuantitativos y revisiones, que describan el uso de terapias tópicas para el dolor en pacientes con HNM. Conclusión: Este estudio permitirá clasificar y discutir las terapias tópicas disponibles, y recomendar futuros estudios primarios.

Background: UK National Institute for Health and Care Excellence (NICE) draft clinical guidelines (CG) (2018) regarding aortic aneurysm repair were disputed internationally. We aim to appraise the academic response to the draft CG in terms of quantity and scientific quality by reviewing published conference abstracts from three major national and international, UK meetings. Methods: Abstracts related to aortic practice from The Vascular Societies Annual Scientific Meeting, British Society for Endovascular Therapy (BSET) & Charing Cross (CX) meetings from 2019 were reviewed for methodology, sample size, data collection period, scientific quality and conclusions that supported or conflicted the draft guideline. Results: A total of 549 abstracts were identified from VSGBI, BSET and CX abstract books of which, 226 (41.2%) were related to aortic practices. Of these, 115 (50.9%) were related to EVAR. Twenty-two of these abstracts (19.1%) were identified as having findings relevant to the draft guidelines. Eighteen (15.7%) were identified as findings that potentially conflict the draft CG and 4 (3.5%) that could support the initial recommendations. Six abstracts (5.2%) made direct reference to or challenged the draft CG. The median data collection period was 4 years. The median sample size was 102 patients. In general, scientific quality was poor, with 82% of selected abstracts were graded at level 2b. Conclusion: We have demonstrated a concerted response to the draft NICE clinical guidelines relating to the treatment of abdominal aortic aneurysms at three large scientific meetings. As a result of which and other factors, significant changes were made to the finalized NG156. There is still paucity in evidence regarding the long-term safety and cost-effectiveness of EVAR.

Objective In July 2018, NHS England, introduced a pause on vaginal mesh, including the mid-urethral sling (MUS) for treatment of stress urinary incontinence (SUI). NICE guidelines recommend MUS as one of the surgical options for SUI. The aim of our study was to investigate healthcare professionals choices for surgical treatment of SUI, if conservative measures failed. Study design The urogynaecology department at our tertiary level hospital devised a questionnaire using SurveyMonkey. This was distributed via email to 1058 healthcare professionals of different medical backgrounds. The surgical options were based on the NICE guideline and its patient decision making aid. We also used surgical information from the British society of Urogynaecology (BSUG) and British association of urological surgeons (BAUS). Results We received 214 responses of which 204 were complete. Twenty six percent of replies were from obstetricians and gynaecologists, 36 % had over 20 years experience and 79 % were female. Forty four percent had no previous knowledge of surgical options. Mid-urethral sling was the most popular choice based on description, success and specific complications. Urethral bulking agent was the only option that increased in popularity after describing complications. Twenty two percent would avoid surgery due to the risk of complications. Conclusion This is the first study evaluating healthcare professionals surgical choice for SUI. Despite negative media publicity and NHS pause on MUS, it was still the most popular choice before and after informing of specific complications. The urethral bulking agent was the only surgical treatment, which increased in popularity after considering complications.

Objective Use of colour duplex ultrasound (CDUS) and computed tomography angiography (CTA) for infrarenal endovascular aortic aneurysm repair (EVAR) surveillance differs in internationally published guidelines. This study aimed firstly to compare CDUS detection of significant sac abnormalities with CTA. Secondly, a sensitivity analysis was conducted to compare financial estimates of the, predominantly CDUS based, local and Society of Vascular Surgery (SVS) protocols, the risk stratified European Society of Vascular Surgery (ESVS) protocol, and the CTA based National Institute of Health and Care Excellence (NICE) protocol. Methods Agreement between CDUS and CTA was assessed for detection of significant sac abnormalities. Surveillance protocols were extrapolated from published guidelines and applied to infrarenal EVAR patients active on local surveillance at a large, single centre. Surveillance intensity was dependent on presence of endoleak and subsequent risk of treatment failure in accordance with surveillance recommendations. Estimates for each surveillance protocol were inclusive of a range of published incidences of endoleak, contrast associated acute kidney injury (AKI), and excess hospital bed days, and estimated for a hypothetical five year surveillance period. Results The kappa coefficient between CDUS and CTA for detecting sac abnormalities was 0.68. Maximum five year surveillance cost estimates for the 289 active EVAR patients were £272 359 for SVS, £230 708 for ESVS, £643 802 for NICE, and £266 777 for local protocols, or £1 270, £1 076, £3 003, and £1 244 per patient. Differences in endoleak incidence accounted for a 1.1 to 1.4 fold increase in costs. AKI incidence accounted for a 3.3 to 6.2 fold increase in costs. Conclusion A combined CTA and CDUS EVAR surveillance protocol, with CTA reserved for early seal assessment and confirmatory purposes, provides an economical approach without compromising detection of sac abnormalities. AKI, as opposed to direct imaging costs, accounted for the largest differences in surveillance cost estimates.

BACKGROUND Ictal hypoxaemia is a feature seen in epileptic seizures, characterized by low oxygen saturations, increasing seizure prolongation risk and possibly contributing to sudden unexpected death in epilepsy (SUDEP). High flow oxygen is recommended in the management of seizures by UK's National Institute of Health and Care excellence (NICE); however, the evidence supporting this recommendation is unclear. AIMS To identify the efficacy of oxygen in the seizure treatment. METHOD A scoping review was conducted using PRISMA-ScR guidance. PsycINFO, EMBASE and MEDLINE were searched along with the references section of identified literature. Articles were critically appraised for study, patient, seizure, oxygen therapy and outcome characteristics, summarized and quality-assessed using Sackett's criteria. RESULTS Literature search identified 623 articles of which five met the pre-criteria for full review. One animal study demonstrated favourable effects of oxygen administration. Three human studies also reported favourable effects of oxygen administration, while one reported outcomes that were not statistically significant. Study design concerns in all identified literature confounded the ability to assess efficacy. All five publications were assigned Sackett's score of 2b. CONCLUSION There is a significant lack of evidence to support the efficacy of oxygen administration in epileptic seizures. Future research is needed.

Background The coverage of postpartum care is not ideal, and has not been used very well due to not enough attention being paid to the puerperal women and newborns, especially in developing countries. Practice guidelines on postpartum care provide beneficial practice guidance and help to reduce maternal mortality. However, little is known about the credibility and consistency of those guidelines. This systematic review was conducted to summarize main postpartum care indications and appraise methodological quality of guidelines. Methods Seven literature databases and guideline development institutions and organizations of obstetrics and maternity care were searched. Two reviewers independently assessed guideline quality using the AGREE II instrument, and synthesized consistent and non-consistent recommendations using the content analysis approach. Results Twenty-nine guidelines were included and a total of eight postpartum care indications were identified. Most guidelines focused on care indications and interventions including exclusive breastfeeding, maternal nutrition, home visit, infant or newborn care and sexuality, contraception, and birth spacing. However, indications such as pain or weight management, pelvic floor muscle training, abdominal rehabilitation, and mental health got less attention. Additionally, the overall quality of all involving postpartum care guidelines is relatively good and acceptable. Conclusions Guidelines developed by NICE, RANO, and WHO indicated higher methodological quality. For postpartum care indications, most guidelines are incomplete. Variation in practice guidelines for postpartum care recommendations exists. In the future, implementation research into shared decision-making, as well as further high-quality research to broaden the evidence base for postpartum care indications is recommended. Supplementary Information The online version contains supplementary material available at 10.1007/s10389-021-01629-4.

Background and study aims Endoscopic mucosal resection (EMR) is an effective way to remove large (> 2 cm) colon adenomas. Training about it has not been standardized in fellowship programs. This study was aimed at evaluating the education and knowledge of gastroenterology fellows about EMR of colorectal adenomas. Methods Participation in this survey was offered to 1730 gastroenterology fellows in the United States during the academic year 2019 to 2020. The survey assessed endoscopic mucosal resection training and knowledge and was approved and administered by the American College of Gastroenterology. Results A total of 163 fellows (9.4 %) completed the survey. Only 85 fellows (52.1 %) reported receiving formal education in endoscopic mucosal resection. Fellow confidence was lowest regarding knowing electrosurgery unit settings. Fewer fellows correctly identified Paris 0-IIb (79, 48.5 %; P Conclusions Nearly half of all fellows reported no formal education in EMR and incorrectly ordered its steps. Adenoma assessment by Paris and NICE classifications and electrosurgery unit settings were the most prominent knowledge deficiencies. Incorporation of standardized training about EMR with inclusion of advanced endoscopy rotations appears to be an important educational opportunity during gastroenterology fellowship.

The NICE guideline on managing pregnancy induced hypertension recommends a low dose aspirin as prophylaxis for pre-eclampsia. Eligibility for aspirin is assessed using risk factor-based evaluation using major and moderate risk factors. Understanding prevalence of risk factors as per guideline and the level of adherence of clinicians to guideline are important in managing pre-eclampsia. This study aimed to assess the prevalence of major and moderate risk factors for pre-eclampsia in this population as per NICE guidelines and to understand the clinician's level of adherence to the guideline. A cross-sectional study was carried out in the professorial unit, Teaching Hospital, Anuradhapura, Sri Lanka using a structured data collection sheet to collect data from pregnant women admitted for delivery within a period of one month. Out of 420 pregnant women, 20 (4.5%) had major or moderate risk factors and eligible for aspirin prophylaxis as per NICE guideline. But only seven (35%) of them were identified based on the guideline and given aspirin during antenatal care. There were 11 (2.6%) women with major risk factors but only five were identified and from nine women with moderate risk factors, only two were identified as eligible. Comparatively, identifying eligibility based on major risk factors was higher than moderate risk factors. Although the prevalence of risk factors of preeclampsia is low, there is a gap between NICE guideline recommendations and the actual practice among clinicians in antenatal care from this rural district. Clinicians should be provided with updated information on NICE guideline to improve recognizing risk factors and prescribing aspirin.

Background: Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria. Where indicated, changes are implemented, and further monitoring is used to confirm improvement in healthcare delivery. Objective: This study aimed at clinical Auditing of the normal labour in the department of Obstetrics and Gynecology, Nekhel Central hospital of North Sinai Governorate. Patients and methods: This was a cross-sectional observational study that included 200 pregnant women attending Nekhel Central Hospital for normal vaginal delivery. We compared normal labour management and performance in Nekhel Central Hospital with NICE guidelines. The study was carried out through the period from April 2020 to October 2020. Results: During the first stage of labour, documentation of frequency of contractions was done in 90% women labour according to NICE guidelines. Also, recording pulse, temperature and blood pressure was done in 100% pregnant women. Observation of frequency of passing urine was done in 87.5% women. 75% women underwent a vaginal examination 4 hourly according to NICE guidelines. During the second stage of labour, documentation of frequency of contractions was done for 90.0% women as NICE guidelines. During the third stage of labour, general physical condition and vaginal blood loss were observed in all cases (100%) and this meet NICE guideline. Conclusion: There were missing of important aspects of appropriate care in Nekhel Central Hospital especially those related to appropriateness of care givers-patients interaction, safety and completeness of examinations, and appropriateness of postpartum care. Keywords: Clinical Audit, Normal Labour, Nekhel Central Hospital, North Sinai Governorate.

AIMS Screening all patients newly diagnosed with colorectal cancer (CRC) for possible Lynch syndrome (LS) has been recommended in the United Kingdom since the National Institute for Health and Care Excellence (NICE) released new diagnostics guidance in February 2017. We sought to validate the NICE screening pathway through a prospective regional programme throughout a 5.2-million population during a 2-year period. METHODS AND RESULTS Pathology departments at 14 hospital trusts in the Yorkshire and Humber region of the United Kingdom were invited to refer material from patients with newly diagnosed CRC aged 50 years or over between 1 April 2017 and 31 March 2019 for LS screening. Testing consisted of immunohistochemistry for MLH1, PMS2, MSH2 and MSH6 followed by BRAF mutation analysis ± MLH1 promoter methylation testing in cases showing MLH1 loss. A total of 3141 individual specimens were submitted for testing from 12 departments consisting of 3061 unique tumours and 2791 prospectively acquired patients with CRC. Defective mismatch repair (dMMR) was observed in 15% of cases. In cases showing MLH1 loss, 76% contained a detectable BRAF mutation and, of the remainder, 77% showed MLH1 promoter hypermethylation. Of the patients included in the final analysis, 81 (2.9%) had an indication for germline testing. CONCLUSION LS screening using the NICE diagnostics guidance pathway is deliverable at scale identifying significant numbers of patients with dMMR. This information is used to refer patients to regional clinical genetics services in addition to informing treatment pathways including the use of adjuvant/neoadjuvant chemotherapy and immunotherapy.

Purpose Review of antipsychotic prescribing practices, rationale and follow-up using an internationally standardized audit can be an effective tool to encourage and monitor best practices. The purpose of this study is to audit the current prescribing pattern for people with intellectual disabilities and challenging behaviours in Qatar. Design/methodology/approach This study was based on the challenging behaviour management guidelines recommended by the Royal College of Psychiatrists. All current electronic medical records in the Mental Health Service-Hamad Medical Corporation were examined to identify patients with intellectual disabilities who received antipsychotics for challenging behaviour. Demographic variables, such as age, sex and nationality, were collected. In addition, details of psychiatric diagnoses, prescribed psychotropic medications and diagnoses of epilepsy were also collected. For patients who were prescribed antipsychotic medication, the clinical rationale for such medication was collected along with evidence of side effect monitoring to allow performance against the audit standards to be measured. Findings This is the first audit on prescribing practices in people with intellectual disability and challenging behaviour in the state of Qatar. The results of this study regarding the pattern of prescribing practices for patients with intellectual disability and challenging behaviour reflect the limitation in knowledge and experience among non-specialist practitioners within mental health service. The result may be helpful to support the development of specialist service provision to improve the care for such vulnerable group. The result may also help other medical centres and clinicians by providing an improved understanding of possible deviations from the best medical practices. Originality/value This is the first audit on prescribing practices in people with intellectual disability and challenging behaviour in the state of Qatar. The study is also noteworthy as, to the best of the authors’ knowledge, it is one of only a few studies on antipsychotic prescribing for patients with intellectual disability and challenging behaviour in the Middle East; therefore, it will be useful in raising awareness and promoting the best practices in the Middle East region. This study is also among the first few studies that were designed based on the four audit standards by the Royal College of Psychiatrists in this area.

Background There is a growing body of evidence suggesting not all craniotomy patients require postoperative intensive care. Objective To devise and implement a standardized protocol for craniotomy patients eligible to transition directly from the operating room to the ward-the Non-Intensive CarE (NICE) protocol. Methods We preoperatively identified patients undergoing elective craniotomy for simple neurosurgical procedures with age Results From February 2018 to 2019, 63 patients were included in the NICE protocol with a median age of 46 yr and 65% female predominance. Of the operations performed, 38.1% were microvascular decompressions, 31.7% were craniotomy for tumor, 15.9% were cavernous malformation resections, and 14.3% were Chiari decompressions. No patients required transfer to the intensive care unit (ICU). Median length of stay was 2 d. There was an 11.1% overall readmission rate within the median follow-up period of 48 d. Three patients (4.8%) required reoperation at time of readmission within the follow-up period (1 postoperative subdural hematoma, 2 cerebrospinal fluid leak repair). None of these complications could have been identified with a postoperative ICU stay. Conclusion In our pilot trial of the NICE protocol, no patients required postoperative transfer to the ICU.

Aims: The aim of this retrospective observational study was to report on the impact of adopting the Joint British Diabetes Society for Inpatients (JBDS-IP) guidelines on the achievement of targets recommended by the National Institute for Health and Care Excellence (NICE) and the maternal and neonatal outcomes.Methods: We analysed case records of pregnant women with diabetes who delivered in the period between November 2017 and October 2018 from our data base ‘Euroking’ (Wellbeing Software Ltd, Mansfield). Data were collected in relation to the availability of a dedicated prescription chart in the notes, capillary blood glucose (CBG) monitoring, use of variable rate intravenous insulin infusion (VRIII), maintenance of CBG targets within 4.0–7.0 mmol/L, maternal hypoglycaemia during labour when on VRIII and neonatal hypoglycaemia.Results: Sixty women with diabetes in our database delivered during this period. Thirty-six (60%) were monitored with hourly CBG monitoring and 30 (50%) achieved CBG levels within the NICE recommended target range. Only five women (8.3%) were started on VRIII. There was no maternal hypoglycaemia in the VRIII group. One baby (1.7%) developed mild neonatal hypoglycaemia.Conclusion: Adoption of JBDS guidelines contributed to 60% of women with diabetes receiving complete CBG monitoring, of whom 70% achieved the NICE recommended target of 4.0–7.0 mmol/L during labour and birth. Repeat CBG measurements before starting VRIII, strict adherence to clear JBDS guidelines and protocols, daily review by the diabetes team during the working week and appropriate use of VRIII was associated with good maternal and neonatal outcomes.

Based on new trial data regarding immune checkpoint inhibitors (ICIs), the detection of high-grade microsatellite instability (MSI-H) or underlying deficient mismatch repair protein (dMMR) is now becoming increasingly important for predicting treatment response. For the first time, a PD‑1 ICI (pembrolizumab) has been approved by the European Medicines Agency (EMA) for first-line treatment of advanced (stage IV) dMMR/MSI‑H colorectal cancer (CRC). Further indications, such as dMMR/MSI‑H endometrial carcinoma (EC), have already succeeded (Dostarlimab, 2nd line treatment) and others are expected to follow before the end of 2021. The question of optimal testing in routine diagnostics should therefore be re-evaluated. Based on a consideration of the strengths and weaknesses of the widely available methods (immunohistochemistry and PCR), a test algorithm is proposed that allows quality assured, reliable, and cost-effective dMMR/MSI‑H testing. For CRC and EC, testing is therefore already possible at the primary diagnosis stage, in line with international recommendations (NICE, NCCN). The clinician is therefore enabled from the outset to consider not only the predictive but also the prognostic and predispositional implications of such a test when counseling patients and formulating treatment recommendations. As a basis for quality assurance, participation in interlaboratory comparisons and continuous documentation of results (e.g., QuIP Monitor) are strongly recommended.

Objectives: Research has demonstrated that psychological therapies are not routinely delivered in acute mental health inpatient settings despite being recommended by the National Institute for Health and Care Excellence (NICE) guidelines. This study aimed to identify the barriers and facilitators to implementing psychological therapies in acute mental health inpatient settings. Methods: A systematic review and narrative synthesis was undertaken. Primary studies were included if they examined the implementation of a NICE recommended psychological therapy in acute psychiatric inpatient settings and were of any study design. Four databases were searched for eligible studies (MEDLINE, CINAHL Plus, PsycINFO and Embase) and Google Scholar. Results: A total of 16 studies (a mixture of both qualitative and quantitative methodologies) were included in the review, and the majority evaluated the implementation of Cognitive Behaviour Therapy. Overall, the literature was deemed to be of poor to moderate quality. The main barriers to the implementation of psychological therapy were the busy nature of the ward, multi-disciplinary professionals not being suitability trained and the acute nature of service users mental health difficulties. Facilitators to implementation included the adaptation of interventions to be specifically delivered in the acute inpatient setting, training of multi-disciplinary professionals, leadership support with the delivery of psychological therapies and prioritising the therapeutic relationship. Conclusions: There is a requirement for senior management to prioritise the implementation of psychological therapies and update clinical guidelines to describe modifications necessary to implement psychological therapies in acute inpatient settings. Future research should improve their methodological quality and continue to develop the evidence base of brief psychological therapies in acute inpatient settings.

Despite widespread evidence of the effectiveness of lipid modification for the reduction of cardiovascular disease (CVD) risk, lipid modification goals are commonly underachieved in the United Kingdom (UK). In order to understand current UK lipid management guidance and the corresponding attainment of recommended lipid lowering goals relating to treatment with statins and ezetimibe, a literature review was conducted using PubMed focusing on publications between January 2017 and February 2020 in order to capture the most up-to-date literature. Identified publications were reviewed against key clinical guidelines for lipid management in relation to CVD risk from the National Institute for Health and Care Excellence (NICE, CG181), the Scottish Intercollegiate Guidelines Network (SIGN, 149) and European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS). Cholesterol lowering goals are central to current lipid lowering therapy guidance, although specific goals vary depending on the guideline and patients’ individual risk profile. Current guidance by NICE and SIGN specifies that treatment should achieve a greater than 40% reduction in non-high-density lipoprotein cholesterol (non-HDL-C) at 3 months of treatment, while the ESC/EAS place emphasis on the lowering of low-density lipoprotein (LDL-C) and total cholesterol. Yet, despite widespread availability of guidance and consistent messaging that lipid lowering goals should be ambitious, current evidence suggests a significant proportion of UK patients have sub-optimal reductions in cholesterol/non-HDL-C/LDL-C. The reasons for this are reported to be multifactorial, including a lack of compliance with guidelines, particularly regarding high-intensity statin prescribing, patient adherence, statin intolerance and statin reluctance as well as wider genetic factors. A number of possible strategies to improve current lipid management and attainment of lipid-lowering goals were identified, including improving the patient-healthcare professional partnership, conducting audits of local prescribing versus guidance, implementing plans for the refinement of current services and considering alternative options such as cost-effective single pill combinations for improving adherence.

Lower urinary tract symptoms (LUTS) in men commonly occur as a consequence of benign prostatic hyperplasia (BPH), also known as prostate enlargement. Treatments for this can involve electrosurgical removal of a section of the prostate via transurethral resection of the prostate (TURP). This can be performed using either monopolar or bipolar electrosurgery. Bipolar TURP uses saline for irrigation rather than glycine, which drastically reduces the risk of TUR syndrome complications, thus allowing for increased procedure time if needed. The PLASMA system (formally known as TURis) is a bipolar TURP electrosurgery system used to treat LUTS secondary to BPH. National guidance recommending the use of TURis in the UK NHS was issued in 2014 by NICE and we now report the updated contribution from Cedar that was included in the update of that guidance for 2021. The evidence in this review suggests that the PLASMA system could be beneficial to patients in relation to hospitalisation and catheterisation time compared with monopolar TURP (mTURP). However, it appears to be comparable to mTURP for urological outcomes and worse for post-operative haematology outcomes such as decline in sodium and haemoglobin levels. Adverse events, however, occurred much less with PLASMA use.

Background: Childhood fever remains a significant health problem because of the convulsion risk it poses to the child as well as the parental anxiety it provokes. Tepid sponging of such children remains commonplace in tropical climates despite the lack of evidence to support it.Objective: To evaluate the effectiveness of tepid sponging in hot tropical climatesMethods: NICE systematic review methodology was used. Medline and EMBASE were searched from their inception to date. Eligibility criteria included a) studies of randomised controlled trial (RCT) design b) children aged 2 to 120 months c) the use of tepid sponging alone in one arm and paracetamol in the other arm of the experiment. Eligible studies were critically appraised with NICE risk of bias tool. The outcome of interest was the number of afebrile children 2 hours after intervention. The outcome data from eligible studies were pooled for meta-analysis using random effects.Findings: Out of the 201 papers retrieved from the electronic search, two studies met the inclusion criteria. The meta-analysis found that tepid sponging was less effective than paracetamol at relieving fever two hours post-intervention (RR=0.25, 95% CI 0.08-0.79]).Conclusion: Tepid sponging was not effective against fever. There is the need to modify existing local clinical protocols to reflect the new evidence and international guidelines.