National Institute For Health And Care Excellence Research Articles

National Institute of Health and Care Excellence Clinical Criteria for the Diagnosis of Knee Osteoarthritis: A Prospective Diagnostic Accuracy Study in Individuals with Type 2 Diabetes.

The National Institute of Health and Care Excellence (NICE) criteria for osteoarthritis (OA) obviate the need for physical exam or imaging, and their use may improve timely diagnosis of OA. However, they have not been validated. Within a larger study of individuals with type 2 diabetes, participants with and without self-reported knee pain underwent assessment of the NICE criteria for knee OA by questionnaire (index test), and clinical evaluation for established or possible knee OA by a rheumatologist (reference standard). We calculated the sensitivity, specificity, likelihood ratio positive (LR+) and likelihood ratio negative (LR-) of the NICE criteria and modified NICE criteria without the stiffness criterion. Our study included 96 participants: mean age 65.4 (SD 8.3) years and 52% were women. Individuals who fulfilled NICE criteria for knee OA (55.2%) included a spectrum of pain severity on a 11-point pain numeric rating scale with a median score of 5 (range: 1-9). Rheumatologist assessment identified 56 (58.3%) participants with symptomatic knee OA. The sensitivity, specificity, LR+, and LR- of NICE criteria for symptomatic knee OA were 0.84 (95% CI 0.74, 0.94), 0.85 (95% CI 0.74, 0.96), 5.6 and 0.19, respectively. For modified NICE criteria, these were 0.89 (95% CI 0.82, 0.97), 0.85 (95% CI 0.74, 0.96), 5.93 and 0.13. The NICE criteria have high sensitivity and specificity for detecting symptomatic knee OA in a population with type 2 diabetes. We found that a modified version, omitting the stiffness criterion, performed similarly. These criteria should be validated in other settings and populations.

GLIOMA-RELATED EPILEPSY

Diffuse low-grade gliomas (LGGs), originating from glial tissue, have a propensity to progress to higher-grade tumors over time, presenting a complex challenge in clinical management. Glioma-associated epilepsy is a significant clinical indicator influencing both treatment strategies and prognostication. This study aims to assess the impact of glioma-related epilepsy on treatment outcomes and explore the current management guidelines. Material and Methods A retrospective analysis was conducted on 38 patients diagnosed with LGGs (WHO grades 2 and 3) treated in our neurosurgical department from 2013 to 2023. The focus was on glioma-related epileptic seizures, with outcomes evaluated using the Engel classification six months post-surgery. Additionally, anti-seizure medication (ASM) regimens were reviewed, and current National Institute for Health and Care Excellence (NICE) guidelines on low-grade gliomas were synthesized. Results Of the 38 patients, 30 had diffuse astrocytoma and 8 had oligodendroglioma. Among those with glioma-related epilepsy (n=25), management strategies included biopsy only (8%), gross total resection (GTR) (40%), subtotal resection (StR) (32%), and partial resection (PaR) (20%). No significant correlation was found between seizures and tumor volume, growth rate, or histological findings. However, a positive correlation between the extent of surgical resection and improved Engel outcomes was observed. Discussion Existing research suggests that early seizures may be a favorable prognostic indicator for malignant progression-free and overall survival. Epilepsy significantly impacts the quality of life for glioma patients. Exploring targeted epilepsy surgery for glioma-related seizures could potentially enhance patient outcomes and quality of life posttreatment. Conclusion Advancing approaches in epilepsy surgery for glioma-related seizures holds promise for improving patient quality of life and treatment efficacy. Further investigation into these strategies is warranted.

Reducing Surgical Site Infections in Neurosurgery During the Intra-operative Phase: An Audit of National Institute for Health and Care Excellence (NICE) Guideline Adherence at a Major Trauma Centre.

Surgical site infections (SSIs) pose significant risks to patient safety and healthcare systems globally despite preventive measures. This study audits compliance with the National Institute for Health and Care Excellence (NICE) guidelines for SSI prevention during the intra-operative phase in the Neurosurgery Department at Salford Royal National Health Service (NHS) Foundation Trust. Conducted in two audit cycles from October 2022 to October 2023, the study assessed adherence to 19 key parameters aimed at minimising SSIs. Significant improvements were observed in various areas, including antibiotic prophylaxis information (from 44% to 90%) and bodywash compliance (from 14% to 80%). Compliance with skin preparation protocols also showed marked progress, with antiseptic application time improving from 12% to 80%. However, areas such as double gloving (increased from 36% to 44%) and the use of antimicrobial sutures (from 2% to 30%) indicate opportunities for further enhancement. The findings underscore the effectiveness of targeted interventions and the importance of continuous education and evaluation of surgical practices to reduce SSIs, ultimately improving patient outcomes and alleviating financial burdens on the NHS. Future audits are recommended to ensure sustained compliance and quality of care in Neurosurgery.

Improving Patient Care and Streamlining Follow-Up: Compliance With National Institute for Health and Care Excellence (NICE) Guidelines for Pediatric Distal Radius Buckle Fractures

Improving Patient Care and Streamlining Follow-Up: Compliance With National Institute for Health and Care Excellence (NICE) Guidelines for Pediatric Distal Radius Buckle Fractures

HPB SO61 - Benefits of Dual-surgeon On-call team on Emergency Laparoscopic Cholecystectomy – a Single Centre Experience

Abstract Background Since 2015, UK national guidance from National Institute for Health and Care Excellence (NICE) has been to offer laparoscopic cholecystectomy for patients presenting with acute cholecystitis within 7 days of admission. The aim of this study was to measure the benefits of a second team of surgeons doing emergency operations (first team dealt with emergency admissions and referrals) in terms of length of stay, conversion to open, morbidity, mortality, bile duct injury and rate of early cholecystectomy in a UK based district general hospital. Method Retrospective analysis of a prospectively maintained database was collected from electronic health records, admission and operative notes. Results were extracted in terms of index laparoscopic cholecystectomy, rate of conversion, intra-operative cholangiography, associated morbidity, mortality, bile duct injury, conversion to open, readmission rate and length of stay. The numbers and rates of cholecystectomy over the last six years duration was collected and compared year-on-year period, since early 2019 after the implementation of dual-surgeon on-call cover. Results Altogether, there was 944 cholecystectomy performed within 14 days, out of which 74% of cases was operated within the first week of presentation <8 days since admission. Majority of cholecystectomy was performed laparoscopically, there were twenty-three (2.43%) conversion to open, forty-six sub-total cholecystectomies (4.87%),intraoperative cholangiography was performed in 28.4% of cases and Indocyanine green (ICG) cholangiography was used in 50.5% of all cases. Average length-of-stay (LOS) was 2.2 days, there were eight cases (0.84%) of post-op bile leak, one bile-duct injury, one case of post-operative bleed, one case of small bowel injury and two deaths. Conclusion With the adoption of dual-surgeon on call, early laparoscopic cholecystectomy benefits both patient and hospital. It reduces time to surgery for patients, decreases overall length of stay, and reduces readmission rates and cost, with similar morbidity and mortality.

Straight-to-Test Pathway in Faecal Immunochemical Testing (FIT)-Negative Patients: A Cost-Effective Approach.

Colorectal cancer (CRC) is the fourth most common malignancy in the UK and represents a high-volume diagnostic and clinical burden on the National Health Service (NHS). To maximise the use of limited diagnostic resources and increase efficiency, the colorectal services at University Hospitals North Midlands Trust (UHNM) developed the triage-to-test (TTT) service with risk stratification for diagnostic testing in patients with suspected colorectal cancer using faecal immunochemical testing (FIT) result. Our retrospective cohort study looked at the pick-up rate of colorectal cancer (CRC) and non-colorectal cancer (non-CRC) in FIT-negative patients. The study was a retrospective review of all symptomatic patients over 18 years of age who had undergone FIT testing in the community between 1November 2021 and 11February 2022 and whowere referred directly to the UHNM colorectal pathway from primary care (n=2,374). FIT negativity was set at <9.9 μg/g of faeces, as per the National Institute for Health and Care Excellence (NICE) DG30 guidelines. Patients were investigated and risk stratified in accordance with their FIT result and presenting symptoms. About 61.5% of patients referred were FIT negative (n=1,459) and 38.5% were FIT positive (n=915). Of those FIT-negative patients, 82 were excluded as their clinical outcomes were pending at the time of analysis. FIT positivity conferred a greater likelihood of colorectal cancer when compared with FIT-negative patients (p<0.0001). FIT-negative patients were most likely to have no significant pathology (32.5%, n=474). Incidence of colorectal cancer in the FIT-negative group was 0.5% (n=7) compared with 9.8% (n=89) in the FIT-positive group (odds ratio: 5.252, 95% CI: 4.012-6.875). Within the FIT-negative cohort, five patients were diagnosed with rectal cancer, one proximal descending colon cancer and one caecal cancer. The use of a FIT-negative TTT pathway ensures that any symptomatic patients presenting with red flag symptoms can be investigated appropriately. It also provides reassurance to clinicians who have an ethical duty to investigate patients in whom they suspect sinister pathology. Moreover, a triage-to-Test pathway reduces outpatient capacity burden onhealthcare trusts as they may send patients directly for investigation.

The Use of Real-World Data for Estimating Relative Treatment Effects in NICE Health Technology Assessment Submissions: A Review.

This paper investigates the current use of real-world data (RWD) for estimating relative treatment effects in National Institute for Health and Care Excellence (NICE) health technology assessment (HTA) submissions. This review included 64 HTA submissions, which accounted for approximately 11% of the total NICE HTA submissions between January 2016 and December 2023. The main sources of RWD considered in the submissions were disease registries and electronic health records. RWD were primarily used to provide an external control arm to enable comparisons within single-arm trials and to inform long-term treatment effects when extrapolating survival data beyond the trial follow-up. Adjustments for potential systematic differences between treatment groups have improved over time; however, approximately one-third of the submissions still relied on unadjusted treatment comparisons. We found that approximately 10% of NICE HTA submissions used RWD to directly inform treatment effects estimation. Over one-third of the submissions relied on naïve and/or unadjusted treatment comparisons, which may have introduced biases. To ensure that RWD provide sound evidence for HTA, submissions should follow published guidelines, including the NICE real-world evidence (RWE)framework.

Improving the non-ST-segment elevation acute coronary syndrome (NSTEACS) pathway using quality improvement methodology

BackgroundThe National Institute for Health and Care Excellence (NICE) guideline quality standard for non-ST-segment elevation acute coronary syndrome (NSTEACS) pathway states that adults who have an intermediate or higher risk...

Use of Uterine Artery Embolization for the Treatment of Uterine Fibroids: A Comparative Review of Major National Guidelines.

Fibroids cause significant morbidity, including anemia, pelvic pain, and infertility. It is imperative that healthcare providers are well-versed on the varying treatments available for fibroids. Specifically, uterine artery embolization (UAE) is a treatment that improves anemia, pelvic pain, and quality of life. The purpose of this article is to compare international guidelines on UAE to offer best practices to healthcare providers. Guidelines from the American College of Obstetrics and Gynecology (ACOG), The Royal College of Obstetricians and Gynaecologists (RCOG) and the Royal College of Radiologists, National College of French Gynecologists and Obstetricians (CNGOF), The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), the Society of Obstetricians and Gynaecologists of Canada (SOGC), and the National Institute for Health and Care Excellence (NICE) were reviewed alongside peer-reviewed PubMed articles. A comparative review of major international guidelines was conducted to encompass potential geographical, cultural, and societal variances with UAE. Review of data revealed guidelines agree with many constituents surrounding treatment of fibroids with UAE. Guidelines diverge regarding offering UAE for small fibroids, intracavitary/submucosal fibroids, and pedunculated serosal fibroids with variations on suggested imaging. Most agree that an experienced care team including a gynecologist and interventional radiologist should be included. Preoperative antibiotics and IUD removal may be recommended. UAE for patients who desire fertility remains an option after counseling within most guidelines. UAE is a safe, efficacious, and cost-effective alternative to hysterectomy and myomectomy. Including UAE as a treatment option during the patient counseling process is critical. Guidelines vary based on data interpretation and are based on clinical research and expert opinion. Due to mixed data and lack of randomized controlled trials, organizations differ when offering UAE to patients who wish to preserve fertility. It is vital to note emerging studies supporting the safety of UAE for subsequent pregnancy.

Compassionate and Safe Home Birth Transfer

This article aims to develop a recommendation by the National Institute for Health and Care Excellence (NICE), alluding to a more compassionate approach to home birth transfer. It overviews solutions towards this through operational planning and suggestions for core skills to enhance effective and compassionate homebirth transfer planning and preparation. It underscores the crucial role of midwives in planning and executing a transfer from home to hospital, making them feel valued and integral to the process.

Non-Invasive Therapeutic Approaches for Mechanical Low Back Pain: An Integrative Systematic Review

Background: Mechanical low back pain (LBP) is one of the most prevalent musculoskeletal conditions, affecting a significant portion of the global population at some point in their lives. It is characterized by pain in the lumbar region without an obvious inflammatory or infectious origin, typically exacerbated by movement, posture, or mechanical load. LBP, whether acute, subacute, or chronic, is a leading cause of temporary and permanent disability, with significant economic repercussions due to lost workdays and healthcare costs. Recent clinical guidelines, such as those from the American College of Physicians (ACP) and the National Institute for Health and Care Excellence (NICE), emphasize the importance of non-invasive interventions for managing mechanical LBP, particularly in acute and chronic cases. In this context, this systematic review aims to consolidate current evidence on available therapeutic interventions, focusing on non-invasive treatments. Objective: To evaluate the available evidence on non-invasive therapeutic interventions for the treatment of mechanical low back pain. The review aims to synthesize international clinical guideline recommendations and identify the most effective practices for reducing pain and improving functional outcomes. Methods: This review was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Randomized controlled trials, systematic reviews, and clinical guidelines published up to 2023 addressing the management of mechanical low back pain in adults were included. Databases such as PubMed, Cochrane Library, and grey literature sources, including guidelines from medical societies, were searched. The study selection process followed strict eligibility criteria, including publications in English and Portuguese focused on non-invasive treatments for LBP. The methodological quality of the studies was assessed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) tool. A total of 15 studies met the inclusion criteria, covering a range of non-invasive interventions such as physical therapy, exercise, acupuncture, manual therapy, and pharmacological approaches. Results: Evidence suggests that exercise-based interventions, particularly programs focused on muscle strengthening and stretching, are effective in reducing pain and improving functional outcomes in patients with mechanical LBP. Manual therapies and acupuncture also demonstrated benefits, albeit with less robust evidence. Reviewed guidelines recommend caution in the use of pharmacological interventions, such as nonsteroidal anti-inflammatory drugs (NSAIDs), particularly in chronic cases. Conclusion: This review highlights that non-invasive therapies, especially supervised exercise programs, represent the most effective and safe treatment for mechanical low back pain. The revised international guidelines reinforce the importance of avoiding early invasive interventions, except in cases of persistent or refractory pain. Appropriate management of mechanical LBP should be individualized, integrating evidence-based interventions to promote functional rehabilitation and minimize the impact of pain on patients' quality of life.

A national survey of first line antibiotic use in neonatal units - and the potential scope for iatrogenic sensorineural hearing loss prevention.

National Institute for Clinical Excellence (NICE) guidance for the management of neonatal sepsis recommends a first-line antibiotic regimen containing an aminoglycoside (gentamicin). Aminoglycoside exposure causes sensorineural hearing loss in individuals with a specific mitochondrial genetic variant (m.1555A>G). This variant can be detected promptly (in <30 min) by a point of care test. NICE does allow for variation in antibiotic regimes depending on local microbiology guidance. As practices can vary, this survey aimed to determine the current use of first-line antibiotic agents within neonatal units and postnatal wards across the UK. A telephone survey was conducted across all neonatal units in the United Kingdom. Responses were requested from a member of the neonatal team experienced in neonatal septic screening processes. One response was recorded per unit. Of the 187 neonatal units, 186 (99%) responded to the survey. One unit declined to participate. The survey results show most neonatal units (93%) and postnatal wards (74%) across the United Kingdom use aminoglycosides as first-line antibiotic agents. Antibiotic regimes varied between different units and between different locations within the same hospital (NICU vs. postnatal wards). In cases where there was a contraindication to aminoglycosides, the most common alternative antibiotic was cefotaxime. Most neonatal units in the UK use an aminoglycoside antibiotic as first-line agent for suspected sepsis. This places infants with the m.1555A>G genetic variant at risk of iatrogenic hearing loss. There needs to be integration of point-of-care genetic testing within the neonatal septic screening pathway.

Effectiveness of paediatric asthma hubs: a clinical pilot study

BackgroundChildren and young people (CYP) with asthma in the UK are at higher risk of poor outcomes compared with other high-income European countries due to factors including poor access to high-quality asthma reviews, diagnostic testing and inconsistent postattack reviews. The Leicester Integrated Care Board funded the first UK pilot asthma hub for CYP, to investigate the feasibility and effectiveness of hubs, in providing postattack reviews along with providing asthma education, the opportunity to carry out diagnostic lung function tests and optimise treatment.MethodsClinical pilot study including CYP aged 4–17 years referred to the hub with uncontrolled asthma or postattack from November 2021 to April 2022. CYP received a structured clinical assessment including National Institute for Health and Care Excellence (NICE) first-line diagnostic investigations for asthma including spirometry, bronchodilator reversibility (BDR) and fraction of exhaled nitric oxide (FeNO).ResultsOf 312 CYP referred (mean age 8.6±3.2 years; 42% women), 266 (85.3%) attended their appointment. Median time from referral to review was 2 days (IQR 1–3). Three CYP (1.1%) were severely unwell at review and required further hospital treatment. In the 231 CYP who completed first-line tests, asthma was confirmed for 73 (31.6%) based on NICE diagnostic criteria for CYP. Twenty-two per cent of children with normal baseline spirometry had ≥12% BDR.ConclusionPaediatric asthma hubs are a feasible model of care to deliver CYP postasthma attack reviews and identify high-risk patients requiring further treatment. Spirometry, BDR and FeNO testing allowed diagnostic confirmation in a significant proportion of CYP.

Delivering shared decision-making before transcatheter aortic valve implantation using digital and remote techniques to enhance patient engagement and convenience

Abstract Introduction Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement for patients with aortic stenosis. However, the choice between TAVI, surgery, wait and watch or conservative management needs to be based upon multiple factors including comorbidity, life expectancy, anatomy, local experience and, critically, informed patient preference. In this context, engaging patients in a shared decision-making (SDM) process becomes essential, but this practice is generally underused. Purpose To comply with both international guidance and the National Institute for Health and Care Excellence (NICE) UK recommendations, in January 2023 we established a formal SDM pathway for TAVI, utilising digital solutions as much as possible to minimise the logistic impact for both hospital and patients. We aimed to quantitatively measure the compliance of the digital SDM meeting from the patients’ perspective with the NICE recommended essential and enhanced discussion standards. Methods Patients are contacted when the multidisciplinary heart team recommends TAVI, then offered digital or, where appropriate, physical patient decision aids and a link to a TAVI-specific explanatory video. One week later, patients are invited to a virtual comprehensive SDM meeting where a specialist nurse discusses aortic stenosis and treatment options with the patient as per the NICE recommended standards, allowing time for questioning and review. From December 2022 to June 2023, a custom developed questionnaire was administered to 20 patients prior to, and 28 patients after the implementation of the SDM meeting protocol, directly addressing the patients’ perception of adherence to the NICE standards. This was provided to the patients after the TAVI procedure via an online tool. The answers to the 12 core questions were converted into a Likert scale (1 to 5) and the global satisfaction scores for the 2 patient groups, reported as the average Likert score across the 12 questions, were compared with the Wilcoxon Rank-Sum Test. Results The global satisfaction score was significantly higher for the post-SDM group than for the pre-SDM group (mean 4.27 vs 3.55, p&amp;lt;0.001). The percentage of patients who gave positive (Likert 4-5) responses to each individual question was consistently higher in the post-SDM group. The percentage of patients giving negative (Likert 1-2) responses was substantially lower in the post-SDM group. Conclusions The SDM pathway and the virtual tools provided proved effective in delivering SDM in compliance with international guidance and NICE recommended standards from the patient’s perspective. A similar approach leveraging digital technology to minimise cost and enhance patient convenience could be implemented for other treatments and across other institutions.Questionnaire results

NICE guidance in the rapid access chest pain clinic: does it work?

Abstract Background Rapid Access Chest Pain Clinics (RACPC) were developed following the publication of the National Service Framework for Coronary Heart Disease in 2000(1). The National Institute for Health and Care Excellence (NICE) produces guidelines for the management of patients with recent onset chest pain of suspected cardiac origin(2). In 2016 the guidance was updated and recommended the use of CT coronary angiography (CTCA) as the initial investigation for patients with chest pain which was typical or atypical of angina. Adherence to the guideline may be dependent upon factors such as local availability of CT scanners and clinician preference. The RACPC in this tertiary centre is nurse-run with no medical involvement. There is good engagement with the CT department and in July 2017 the NICE guidance was adopted in the clinic. Purpose To evaluate the use of CTCA as the first line investigation for patients with typical or atypical chest pain. Methods Data from all patients reviewed in the clinic between 01/07/2017 and 31/12/2023 were prospectively collected, entered into a database, and then retrospectively analysed. The data were organised into 3 groups: patients with typical chest pain; atypical pain and those with non-cardiac sounding chest pain. The number of patients in each group who underwent a CTCA, and the outcome of the scan were evaluated. The CT scans were categorised as showing significant coronary artery disease (CAD), non-obstructive CAD, no CAD, or as inconclusive. The outcome of patients who had a positive CTCA was also recorded. Results 2986 patients were reviewed in the RACPC in the above period. 14.2% of patients presented with typical pain, 47.4% with atypical pain, and 30.6% had non-cardiac pain. The remaining patients presented with other symptoms such as breathlessness. CTCA was used as the first investigation in the majority of patients with typical or atypical pain, unless alternative investigations or management were deemed to be more clinically appropriate. In 59.5% of typical and 78.5% of atypical presentations, the CT scan showed no CAD, or non-significant CAD. There was a low incidence of positive scans in both groups, however patients with typical pain were more likely to have significant CAD (Table). All patients who had a CTCA indicating significant CAD, were referred for invasive angiography. 88.0% of typical presentations, and 64.0% of those with atypical pain, underwent revascularisation. No patient who underwent invasive angiography was found to have normal coronary arteries. Conclusion Atypical pain is the most frequent presentation in the RACPC, however the majority of these patients, and most of those with typical pain, do not have significant CAD. Careful assessment and the use of CTCA as the initial investigation, enable the identification of those patients who need invasive angiography. This is a cost-effective strategy which also reduces risk and radiation exposure for patients.

Lyme disease in UK primary care: a knowledge, attitude and practice survey.

Lyme disease (LD) cases in the UK most commonly present within the primary care setting. Despite an upward trend of incidence, little is known regarding general practitioner (GP) experience with diagnosis and treatment. This study aims to describe baseline primary care clinician Knowledge, Attitude and Practice (KAP) in Scotland and England. Online KAP survey on Lyme disease for UK based practising GPs. An online KAP questionnaire was developed for use in UK primary care. The survey was distributed through UK based research networks, professional societies and via social media. 191 complete responses were analysed (England n=130, Scotland n=61). The Scotland-based respondent group had more relevant consultations in the previous 3 years. Respondents from Scotland demonstrated a greater awareness that erythema migrans (EM) is pathognomonic for Lyme disease and that serological testing of this patient group is not indicated. Less common cardiac and neurological symptoms were not as well associated with Lyme disease by both respondent groups for the former and England-based respondents for the latter. Prescribing according to the National institute for Health and Care Excellence (NICE) guidance was identified in 70% of Scotland and 42% of England-based GP responses. Targeted resources may improve clinician confidence on exposure risk, symptom recognition, testing limitations and treatment dose and duration. Scotland-based respondents' better survey performance potentially reflects greater clinical exposure and public awareness of the disease, due to high endemicity within the nation.

A novel screening instrument for the assessment of autism in German language: validation of the German version of the RAADS-R, the RADS-R.

The Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R) demonstrated excellent results in its original study, with a sensitivity of 97% and a specificity of 100% (Ritvo et al. in J Autism Dev Disord 41:1076-1089, 2011). As a result, it was included in the National Institute for Health and Care Excellence (NICE) guidelines (Recommendations | Autism spectrum disorder in adults: diagnosis and management | Guidance | NICE, 2022). The questionnaire includes 80 questions across four subcategories (language, social relatedness, circumscribed interests, sensory motor). So far, the subcategory sensory motor has not been addressed in most available instruments, despite being part of the diagnostic criteria specified in DSM-5 (Falkai et al., in Diagnostisches Und Statistisches Manual Psychischer Störungen DSM-5. Hogrefe, 2015) and ICD-11 (ICD-11 for Mortality and Morbidity Statistics, 2022). In our validation study, we tested a translated German version of the questionnaire in 299 individuals (110 persons with ASD according to ICD-10 F84.0, F84.5, 64 persons with an primary mental disorders (PMD), 125 persons with no disorders). To enhance the practical use of the instrument in clinical everyday practice, the questionnaire was completed by the participants without the presence of a clinician-unlike the original study. Psychiatric diagnoses were established following the highest standards, and psychometric properties were calculated using established protocols. The German version of the RADS-R yielded very good results, with a high sensitivity of 92.5% and a high specificity of 93.6%. The area under the curve (AUC = 0.976), indicates a high quality and discriminatory power of RADS-R. Furthermore, the ROC curve analysis showed that the optimal threshold to distinguish between the ASD and non-ASD groups in the German version of the RAADS-R is a score of 81. In comparison to the RADS-R, the co-administered instruments Social Responsiveness Scale (SRS), Autism Spectrum Quotient (AQ), and Empathy Quotient (EQ) each showed slightly better specificity but worse sensitivity in this sample.The study included individuals already diagnosed with ASD according to ICD-10 (F84.0, F84.5), with or without an primarymental disorders, preventing us from identifying the influence of comorbidities on the RADS-R results. In addition, a self-report questionnaire has generally only limited objectivity and may allow for false representation of the symptoms. The RADS-R compares well with other questionnaires and can provide valuable additional information. It could turn out to be a helpful diagnostic tool for patients in Germany. We propose naming the German version RADS-R (Ritvo Autism Diagnostic Scale - rRevised) to reflect the change in terminology.

Introducing a systematic and sustainable patient safety oversight function in a U.K. arms-length healthcare body

Background The healthcare landscape is experiencing a profound period of change with accelerating developments in medical research, new treatments, care delivery and the use of innovative technology to meet the challenges of delivering care. These changes offer opportunities but as with all innovation, require careful management to reduce the likelihood of harm and error. Objective The National Institute for Health and Care Excellence (NICE) has set out to introduce an adaptable, sustainable and systematic patient safety oversight group to ensure that patient safety is embedded at an organisation level supporting the healthcare system to overcome challenges and deliver high quality care, safely implementing the latest innovations in a timely manner. Method The patient safety oversight group was established through a scoping exercise, led by the senior responsible officer and a small project team. The article sets out the methods used, including extensive internal engagement through structured interviews with senior leadership teams, purposive sampling, data synthesis and reporting. An overview of the group is given and considerations for promoting patient safety information flows and optimising the use of safety signal intelligence are made. Conclusion Through reflection on changing needs within and surrounding the organisation, along with patient safety and complexity literature, NICE has developed an adaptable, systematic and sustainable model for managing patient safety. In addition to generating learning within NICE, the process highlights opportunities for improvement within the patient safety system. Result NICE has developed an adaptable, systematic and sustainable model for managing patient safety.

Understanding the long-term impact of the COVID-19 pandemic on non-muscle-invasive bladder cancer outcomes: 12-Month follow-up data from the international, prospective COVIDSurg Cancer study.

The objective of this study was to report the 12-month oncological outcomes for patients with non-muscle-invasive bladder cancer (NMIBC) within the prospective, international COVIDSurg Cancer study. Eligible patients were aged ≥18 years and scheduled for elective surgical management of NMIBC with curative intent (transurethral resection of bladder tumour [TURBT] or bladder biopsy) from 21 January to 14 April 2020. The primary outcome was disease recurrence within 12 months of previous elective TURBT/bladder biopsy. Secondary outcomes included disease progression within 12 months of previous elective TURBT/bladder biopsy, site-declared delay to surgery from diagnosis as a consequence of COVID-19 and deviation in standard care due to COVID-19. Comparisons were made to cohorts from the pre-pandemic era. Bladder cancer accounted for 2.2% (n= 446) of patients in the COVIDSurg Cancer study, with data contributed by 27 centres across 12 countries internationally. Within this included cohort, 229 patients had NMIBC and 12-month follow-up data available. On application of National Institute for Health and Care Excellence (NICE) criteria, 47.2% were classified as having high-risk disease. Overall disease recurrence and progression rates were 29.3% and 9.7% at 12 months, respectively. In purely high-risk pre-pandemic cohorts, the International Bladder Cancer Group (IBCG) estimates a recurrence rate of 25% at 12 months, and the European Association of Urology (EAU) NMIBC 2021 scoring model estimates a 12-month progression rate of 3.5%. As a consequence of the COVID-19 pandemic, 10.9% of patients had site-declared delay to TURBT/bladder biopsy; 7.4% did not undergo intravesical therapy or had early discontinuation of this; 9.2% did not undergo early repeat resection for high-risk disease; and 18.3% had a delay to cystoscopic follow-up surveillance. This prospective study indicates that there were widespread deviations in usual care for NMIBC during the pandemic and that 12-month oncological outcomes appear to be impaired compared to published pre-pandemic outcomes.

Including carer health-related quality of life in NICE health technology assessments in the United Kingdom.

The impact of health technologies may extend beyond the patient and affect the health of people in their network, like their informal carers. The National Institute for Health and Care Excellence (NICE) methods guide explicitly allows the inclusion of health-related quality of life (HRQoL) effects on carers in economic evaluations when these effects are substantial, but the proportion of NICE appraisals that includes carer HRQoL remains small. This paper discusses when inclusion of carer HRQoL is justified, how inclusion can be substantiated, and how carer HRQoL can be measured and included in health economic models. Inclusion of HRQoL in economic evaluations can best be substantiated by data collected in (carers for) patients eligible for receiving the intervention. To facilitate combining patient and carer utilities on the benefit side of economic evaluations, using EQ-5D to measure impacts on carers seems the most successful strategy in the UK context. Alternatives to primary data collection of EQ-5D include vignette studies, using existing values, and mapping algorithms. Carer HRQoL was most often incorporated in economic models in NICE appraisals by employing (dis)utilities as a function of the patient's health state or disease severity. For consistency and comparability, economic evaluations including carer HRQoL should present analyses with and without carer HRQoL.