Relapse after cessation of weekly tocilizumab for giant cell arteritis: a multicentre service evaluation in England.

OBJECTIVES: The National Health Service in England funds 12 months of weekly subcutaneous tocilizumab (qwTCZ) for patients with relapsing or refractory giant cell arteritis (GCA). During the COVID-19 pandemic, some patients were allowed longer treatment. We sought to describe what happened to patients after cessation of qwTCZ. METHODS: Multicentre service evaluation of relapse after stopping qwTCZ for GCA. The log-rank test was used to identify significant differences in time to relapse. RESULTS: 336 GCA patients were analysed from 40 centres, treated with qwTCZ for a median (interquartile range, IQR) of 12 (12-17) months. At time of stopping qwTCZ, median (IQR) prednisolone dose was 2 (0-5) mg/day. By 6, 12 and 24 months after stopping qwTCZ, 21.4%, 35.4% and 48.6% respectively had relapsed, requiring an increase in prednisolone dose to a median (IQR) of 20 (10-40) mg/day. 33.6% of relapsers had a major relapse as defined by EULAR. Time to relapse was shorter in those that had previously also relapsed during qwTCZ treatment (P = 0.0017); in those not in remission at qwTCZ cessation (P = 0.0036); and in those with large vessel involvement on imaging (P = 0.0296). Age ≥65, gender, GCA-related sight loss, qwTCZ treatment duration, TCZ taper, prednisolone dosing, and conventional synthetic DMARD use were not associated with time to relapse. CONCLUSION: Up to half our patients with GCA relapsed after stopping qwTCZ, often requiring a substantial increase in prednisolone dose. One third of relapsers had a major relapse. Extended use of TCZ or repeat treatment for relapse should be considered for these patients.

Sacral neuromodulation system for treating refractory overactive bladder.

Sacral neuromodulation (SNM) is a therapy system used to improve bladder function, including in people with overactive bladder (OAB). It is safe and can improve quality of life. SNM helps improve symptoms through direct modulation of nerve activity; it involves electrically stimulating the sacral nerves that carry signals between the pelvic floor, spinal cord and the brain and is thought to normalise neural communication between the bladder and brain. If patients with OAB do not respond to non-surgical and conservative options, minimally invasive procedures can be offered, including SNM. SNM is performed in two stages: the trial phase, to assess whether it would be effective in the long term; and permanent implantation. This year, the National Institute for Health and Care Excellence (NICE) released guidance on the Axonics SNM System® for treating refractory OAB. The Axonics System is rechargeable and lasts at least 15 years, minimising the need for repeat surgery. NICE suggests the Axonics System may have cost advantages for the NHS. Having more than one SNM therapy option available increases options for patients, offering them a choice of handsets and rechargeable versus non-rechargeable implants. Three case studies illustrate how the system works in practice.

Fifteen-minute consultation: Developing an advance care plan in partnership with the child and family.

An advance care plan (ACP) is the record of a discussion between an individual (where possible), their professional care givers and those close to them about their future care. When performed well, the process provides all those involved with the opportunity to talk honestly about the future allowing children and their families to retain autonomy and to influence how they are looked after. While this may represent a difficult area of practice for healthcare professionals, both staff and families appear to benefit when the process is fully informed and the child and family are actively involved. This article is enriched by the insight of two bereaved parents, who have engaged actively with the process of advance care planning. As a multidisciplinary writing team, we aim to share our experiences, in the context of recent national guidance, on the use of ACPs.

Age-related references in national public health, technology appraisal and clinical guidelines and guidance: documentary analysis.

Background: older people may be less likely to receive interventions than younger people. Age bias in national guidance may influence entire public health and health care systems. We examined how English National Institute for Health & Care Excellence (NICE) guidance and guidelines consider age. Methods: we undertook a documentary analysis of NICE public health (n = 33) and clinical (n = 114) guidelines and technology appraisals (n = 212). We systematically searched for age-related terms, and conducted thematic analysis of the paragraphs in which these occurred ('age-extracts'). Quantitative analysis explored frequency of age-extracts between and within document types. Illustrative quotes were used to elaborate and explain quantitative findings. Results: 2,314 age-extracts were identified within three themes: age documented as an a-priori consideration at scope-setting (518 age-extracts, 22.4%); documentation of differential effectiveness, cost-effectiveness or other outcomes by age (937 age-extracts, 40.5%); and documentation of age-specific recommendations (859 age-extracts, 37.1%). Public health guidelines considered age most comprehensively. There were clear examples of older-age being considered in both evidence searching and in making recommendations, suggesting that this can be achieved within current processes. Conclusions: we found inconsistencies in how age is considered in NICE guidance and guidelines. More effort may be required to ensure age is consistently considered. Future NICE committees should search for and document evidence of age-related differences in receipt of interventions. Where evidence relating to effectiveness and cost-effectiveness in older populations is available, more explicit age-related recommendations should be made. Where there is a lack of evidence, it should be stated what new research is needed.

Urgent referral for suspected CNS cancer: which clinical features are associated with a positive predictive value of 3 % or more?

BACKGROUND: Urgent referral for suspected central nervous system (CNS) cancer is recommended, but little analysis of the referral criteria diagnostic performance has been conducted. New 2015 NICE guidance recommends direct brain imaging for patients with symptoms with positive predictive values (PPV) of 3 %, but further guidance is needed. METHODS: A 12-month retrospective evaluation of 393 patients referred under previous 2005 NICE 2-week rule criteria was conducted. Analysis was based on the three groups of symptoms forming the referral criteria, (1) CNS symptoms, (2) recent onset headaches, (3) rapidly progressive subacute focal deficit/cognitive/behavioural/personality change. Comparison was made with neuroimaging findings. RESULTS: Twelve (3.1 %) of 383 patients who attended clinic had CNS cancer suggesting the combination of clinical judgement and application of 2005 criteria matched the 2015 guideline's PPV threshold. PPVs for the three groups of symptoms were (1) 4.1 % (95 % CIs 2.0 to 7.4 %), (2) 1.2 % (0.1 to 4.3 %) and (3) 3.7 % (0.1 to 19.0 %). Sensitivities were (1) 83.3 % (95 % CIs 51.6 to 97.9 %), (2) 16.7 % (2.1 to 48.4 %), and (3) 8.3 % (0.2 to 38.5 %); specificities were (1) 37.2 % (32.3 to 42.3 %), (2) 55.5 % (50.3 to 60.7 %) and (3) 93.0 % (89.9 to 95.4 %). Of 288 patients who underwent neuroimaging, 59 (20.5 %) had incidental findings, most commonly cerebrovascular disease. CONCLUSIONS: The 2015 guidance is less prescriptive than previous criteria making clinical judgement more important. CNS symptoms had greatest sensitivity, while PPVs for CNS symptoms and rapidly progressive subacute deficit/cognitive/behavioural/personality change were closest to 3 %. Recent onset headaches had the lowest sensitivity and PPV.

The Continuing Story of the Cost-Effectiveness of Photoselective Vaporization of the Prostate versus Transuretheral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Obstruction.

BACKGROUND: In 2008, a UK assessment of technologies for benign prostatic obstruction concluded negatively about photoselective vaporization of the prostate (PVP), and the 2010 National Institute for Health and Care Excellence guidance caused several UK institutions to abandon PVP. OBJECTIVE: To reassess the costs and effects of PVP versus transurethral resection of the prostate (TURP) on the basis of most recent data. METHODS: The same model was used as in 2008. Transition probabilities were estimated using a Bayesian approach updating the 2008 estimates with data from two meta-analyses and data from GOLIATH, the latest and largest trial comparing PVP with TURP. Utility estimates were from the 2008 assessment, and estimates of resource utilization and costs were updated. Effectiveness was measured in quality-adjusted life-years gained, and costs are in UK pounds. The balance between costs and effects was addressed by multivariate sensitivity analysis. RESULTS: If the 2010 National Institute for Health and Care Excellence analysis would have updated the cost-effectiveness analysis with figures from its own meta-analysis, it would have estimated the change in quality-adjusted life-years at -0.01 (95% confidence interval [CI] -0.05 to 0.01) instead of at -0.11 (95% CI -0.31 to -0.01) as in the 2008 analysis. The GOLIATH estimate of -0.01 (95% CI -0.07 to 0.02) strengthens the conclusion of near equivalence. Estimates of additional costs vary from £491 (£21-£1286) in 2008 to £111 (-£315 to £595) for 2010 and to £109 (-£204 to £504) for GOLIATH. PVP becomes cost saving if more than 32% can be carried out as a day case in the United Kingdom. CONCLUSIONS: The available evidence indicates that PVP can be a cost-effective alternative for TURP in a potentially broad group of patients.

Left Atrial Appendage Occlusion: British Cardiovascular Intervention Society and British Heart Rhythm Society Position Statement.

Percutaneous left atrial appendage occlusion aims to reduce the risk of stroke in patients with AF, particularly those who are not good candidates for systemic anticoagulation. The procedure has been studied in large international randomised trials and registries and was approved by the National Institute for Health and Care Excellence in 2014 and by NHS England in 2018. This position statement summarises the evidence for left atrial appendage occlusion and presents the current indications. The options and consensus on best practice for pre-procedure planning, undertaking a safe and effective implant and appropriate post-procedure management and follow-up are described. Standards regarding procedure volume for implant centres and physicians, the role of multidisciplinary teams and audits are highlighted.

Left Atrial Appendage Occlusion: British Cardiovascular Intervention Society and British Heart Rhythm Society Position Statement.

Percutaneous left atrial appendage occlusion aims to reduce the risk of stroke in patients with AF, particularly those who are not good candidates for systemic anticoagulation. The procedure has been studied in large international randomised trials and registries and was approved by the National Institute for Health and Care Excellence in 2014 and by NHS England in 2018. This position statement summarises the evidence for left atrial appendage occlusion and presents the current indications. The options and consensus on best practice for pre-procedure planning, undertaking a safe and effective implant and appropriate post-procedure management and follow-up are described. Standards regarding procedure volume for implant centres and physicians, the role of multidisciplinary teams and audits are highlighted.

A survey of autistic adults, relatives and clinical teams in the United Kingdom: And Delphi process consensus statements on optimal autism diagnostic assessment for adults.

LAY ABSTRACT: Living with undiagnosed autism can be distressing and may affect mental health. A diagnosis of autism can help self-awareness and self-understanding. However, it can be difficult for adults to access an autism assessment. Clinicians also sometimes find it hard to identify autism in adults. This may mean an autism diagnosis is delayed or missed. In this study, we asked autistic adults, relatives and clinicians how to improve this. The study was in two stages. In the first stage (stage 1), 343 autistic adults and 45 relatives completed a survey. In the survey, we asked questions about people's experiences of UK autism assessment services for adults. Thirty-five clinicians completed a similar survey. Clinicians reported that some autism assessment teams lacked key professionals, for example, psychologists and occupational therapists. We used the information from the three separate surveys to create 13 statements describing best autism assessment services for adults. In stage 2, we asked clinicians for their views on the 13 statements. Clinicians agreed with 11 of the statements. Some autistic adults, relatives and clinicians were positive about autism assessment services, and many also described areas that could be improved. The study findings can be used to improve UK adult autism assessment services and may be helpful for service developments worldwide.

Chronic kidney disease in adults: assessment and management.

Chronic kidney disease (CKD) is a common condition associated with significant amenable morbidity and mortality, primarily related to the substantially increased risk of cardiovascular disease (CVD) in this population. Early detection of people with CKD is important so that treatment can be initiated to prevent or delay kidney disease progression, reduce or prevent the development of complications, and reduce the risk of CVD. Classification of CKD by the estimated glomerular filtration rate and urine albumin to creatinine ratio identifies those at greatest risk of adverse outcomes. This concise guideline highlights the key recommendations of the National Institute for Health and Care Excellence guideline Chronic kidney disease in adults: assessment and management: Clinical guideline [CG182], published in July 2014. It focuses on recommendations most relevant to secondary care physicians.

New NICE referral guidance for oral cancer: does it risk delay in diagnosis?

Changes to guidance about the two-week wait referrals for suspected cancer of the head and neck have created a new recommendation for a general medical practitioner to refer any patients to a dentist under certain criteria. The potential effect of this was assessed based on 91 referrals to an oral and maxillofacial unit. A total of 33 met the criteria for initial referral to a dentist; of these, one was later diagnosed with cancer. We outline the potential deleterious effects the new guidance might have on the rapid diagnosis of oral lesions.

Requirement for cystatin C testing in chronic kidney disease: a retrospective population-based study.

BACKGROUND: Creatinine-based estimated glomerular filtration rate (eGFR) determines chronic kidney disease (CKD) stage, but underestimates renal function. The 2014 updated guidance from the National Institute for Health and Care Excellence (NICE) recommends that GPs reduce overdiagnosis of CKD stage 3a (eGFR 45-60 ml/min/1.73 m2) by using the renal biomarker cystatin C. AIM: To determine the population requirement for cystatin C testing, compared with current national availability of the assay. DESIGN AND SETTING: Retrospective study of primary care laboratory requests in Oxfordshire, England. METHOD: The first creatinine results from tests ordered in primary care over a 6-year period (2008-2014) in a population of 600 000 in Oxfordshire were analysed and the number of patients with CKD stage 3a without proteinuria (who, in accordance with NICE guidance, required cystatin C) was determined. A conservative estimate of the national need was provided by scaling the population of Oxfordshire to the national population (CKD prevalence in the county is below the national average). Cystatin C assay availability was determined using national databases of laboratory assay provision. RESULTS: From a population of 600 000, there were 22 240 individuals with stable stage 3a CKD and no proteinuria. As the population of Oxfordshire equates to 1% of the UK population, there is an initial requirement for at least 2 million people to have their CKD status determined with cystatin C testing. Eight laboratories (2.1% of UK laboratories) reported cystatin C assay provision. CONCLUSION: There is a substantial gap between cystatin C assay requirements in primary care and national assay provision. This is a major barrier to implementing NICE guidance.

No Ifs, No Butts: Compliance with Smoking Cessation in Secondary Care Guidance (NICE PH48) by Providers of Cancer Therapies (Radiotherapy and Chemotherapy) in the UK.

Background: Legislation preventing smoking in public places was introduced in England in July 2007. Since then, smoke-free policies have been extended to the majority of hospitals including those providing cancer therapies. Whilst studies have been conducted on the impact and effectiveness of hospital smoke-free policy in the UK and other countries, there have not been any studies with a focus on cancer care providers. Cancer patients are a priority group for smoking cessation and support and this study aimed to examine implementation of the National Institute Clinical Excellence (NICE) guidance (PH48) in acute cancer care trusts in the UK. Methods: Participants were recruited from UK radiotherapy and chemotherapy departments (total 80 sites, 65 organisations) and asked to complete a 15 min online questionnaire exploring the implementation of NICE guidance at their hospital site. Results: Considerable variability in implementation of the NICE guidance was observed. A total of 79.1% trusts were smoke-free in theory; however, only 18.6% were described as smoke-free in practice. Areas of improvement were identified in information and support for patients and staff including in Nicotine Replacement Therapy (NRT) provision, staff training and clarity on e-cigarette policies. Conclusions: While some trusts have effective smoke-free policies and provide valuable cessation support services for patients, improvements are required to ensure that all sites fully adopt the NICE guidance.

Interdisciplinary management of hip fracture.

Hip fracture is a prevalent age-associated occurrence incorporating both medical and surgical need and a major challenge to public health and NHS resources. Effective management requires coordinated collaboration across specialties, professions and services. This concise guideline focuses on interdisciplinary aspects of hip fracture management abstracted from National Institute for Health and Care Excellence (NICE) clinical guideline (CG124), including the concept and implementation of the Hip Fracture Programme, detection and management of comorbidity and delirium, optimal analgesia, timing of surgery, multidisciplinary mobilisation, rehabilitation and hospital discharge. The recently updated National Hip Fracture Database report and NICE quality standard are potential drivers for progress.

Criteria versus guidelines: Are we doing the best for our paediatric patients?

The National Institute for Health and Care Excellence guidance for the provision of cochlear implants (NICE Technology Appraisal Guidance 166. Cochlear implants for children and adults with severe to profound deafness. 2009. National Health Service National Institute for Health and Clinical Excellence.) are used to develop candidacy criteria by public health funding bodies within the UK. Often the guidance is interpreted as strict 'criteria' whereby clinicians adhere to specific audiometric thresholds without accounting for the acceptable range of performance on individual tests or a child's functional development. In this paper four clinical paediatric case studies are described from two cochlear implant centres which serve to illustrate difficulties in applying NICE guidance as strict criteria. These are presented in the context of recommending more flexible interpretation based on the content of the current guidance along with considerations of circumstances where NICE guidance might be adapted to optimise use of cochlear implant technology within a national framework.