National Institute For Health And Care Excellence Research Articles

Foslevodopa/foscarbidopa (LDp/CDp) in advanced Parkinson’s Disease (aPD): demonstration of savings from a societal perspective in the UK

Aims In advanced Parkinson’s disease (aPD), adequate 24-hour control of OFF-time may not be achievable using oral/transdermal therapies. Clinical trials of foslevodopa/foscarbidopa (LDp/CDP) demonstrate meaningful reductions in OFF-time and OFF-related sleep disturbance in aPD. Previous analyses have only considered direct medical costs: this analysis considers a broader societal perspective (direct non-medical costs, informal care, loss of earnings, productivity, and tax). Methods Inputs for the societal impact model were taken from a cost-utility model comparing LDp/CDp with best medical treatment (BMT), accepted by the UK National Institute of Health and Care Excellence (NICE). Quintiles of normalized OFF-time across a 16-hour waking day in each treatment group were applied to literature-based estimates for direct medical, non-medical, and indirect costs. The resulting state-specific cost estimates were applied to the modelled aPD patient population. Results The model estimates the potential UK population for LDp/CDp at 17,505. Continuous 24-hour delivery of LDp/CDp results in greater time spent in OFF-time states 0–1 (0–4 hours of OFF-time/16-hour waking day) vs BMT alone. Net savings if all eligible patients receive LDp/CDp are £79.1 M in year 1, £235.4 M in year 2, rising to £262.2 M in year 3, declining to £222.9 M in year 4 and £153.7 M in year 5 as disease progresses and the efficacy of LDp/CDp declines. The estimated total net savings are £953 M after 5 years. Results are robust in scenario analyses (excluding costs of excessive sleepiness, earnings loss, productivity, and tax loss). Limitations A NICE-accepted model was used as the economic modelling basis for the societal impact model, however, much of the data was derived from Adelphi datasets, with the potential for inconsistent definitions. Conclusion When considered from a societal perspective, the use of LDp/CDp in aPD patients inadequately controlled on oral therapy is associated with net healthcare and societal annual savings of over £79.1 M vs BMT.

Using Normalisation Process Theory to explore the contribution of stakeholder workshops to the development and refinement of a complex behavioural intervention: the STAMINA lifestyle intervention

BackgroundThe National Institute for Health and Care Excellence (NICE) recommend that men with prostate cancer on androgen deprivation therapy (ADT) are offered twice weekly supervised aerobic and resistance exercise to address side effects of treatment. However, supervised exercise is not routinely offered in standard clinical practice. The STAMINA programme grant for applied research (PGfAR) has been designed to evaluate whether this recommendation can be delivered within standard NHS care. This paper describes how future implementation of NICE recommendations within the NHS was explored during complex intervention development to enable evaluation of a lifestyle intervention.MethodsTwo stakeholder workshops were conducted to explore factors pertinent to future implementation of the STAMINA Lifestyle intervention (SLI). Normalisation Process Theory (NPT) provided the theoretical framework for discussion and analysis. Stakeholder workshop 1 focussed on intervention coherence and buy-in. Stakeholder workshop 2 explored barriers and facilitators for embedding SLI into the context of the NHS, with delivery partner Nuffield Health, in the future.ResultsWorkshops were attended by healthcare professionals (n = 16), exercise professionals (n = 17), members of public involved in PPI including patients (n = 12), health psychologists (n = 2), clinical commissioners (n = 4), cancer charities (n = 3), a cancer alliance (n = 1) and health economist (n = 1). Stakeholders agreed that professional training packages should emphasise the uniqueness of the SLI and underpinning theory and evidence (Coherence). To further engagement, the use of STAMINA champions and information about the delivery partner were recommended to enhance confidence and knowledge (Cognitive participation). Furthermore, a simple communication (Collective Action) and progress reporting system (Reflexive Monitoring) was suggested to fit into existing infrastructure within the NHS and community partner.ConclusionsApplication of NPT within two stakeholder workshops enhanced complex intervention development. Context-specific strategies to support implementation of SLI within the context of a trial were proposed, sensed-checked, and considered acceptable. The organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out were considered (if proven to be effective) and will be explored in the qualitative component of a process evaluation underpinned by NPT.Trial registration(ISRCTN: 46385239). Registered on July 30, 2020.

Induction of Labour: What to Consider

Induction of Labour (IOL) is a method of artificially providing stimulus to the uterus to start the process of labour.1 It utilises iatrogenic therapies such as a synthetic oxytocin, cervical ripening medications, in conjunction with the artificial rupture of membranes, to imitate the physiology of labour and childbirth.2 The indication for IOL is dependent on the clinical need to optimise maternal, fetal and neonatal outcomes, juxtaposed with the potential adverse effects of the IOL process. Indications include uterine, placental and fetal growth disorders, hypertensive conditions and diabetes.3 For example, the National Institute for Clinical Excellence (NICE) recommend IOL between 37 and 38 plus six weeks for pregnant populations who have type 1 or type 2 diabetes, to prevent stillbirth and associated complications.4 The absolute effectiveness of IOL intervention in preserving maternal and fetal health is evident5 however, the World Health Organization (WHO) endorses the consideration of choice of IOL method.6

Medial opening wedge high tibial osteotomy performs similarly irrespective of body mass index.

This study investigates the effect of the body mass index (BMI) on the early (2 years) to midterm (5 years) results of medial opening wedge high tibial osteotomy (MOWHTO). A prospectively maintained single-centre database of 1138 knee osteotomies, between 2002 and2022, was retrospectively reviewed. Adult patients who underwent MOWHTO for symptomatic unicompartmental medial knee osteoarthritis (OA), with varus knee malalignment, having failed conservative management, were included. Patients were categorized into threegroups according to their BMI as per the classification from the National Institute for Health and Care Excellence (NICE): the healthy weight (HW) group (BMI of 18.5-24.9 kg/m2), the overweight (OW) (BMI of 25-29.9 kg/m2), and the obesity (OB) group (BMI ≥ 30 kg/m2). Multiple patient-reported outcome measures (n = 6) were recorded preoperatively and at 2 and 5 years postoperatively. Deformity analysis was undertaken preoperatively and postoperatively. The relative risk (RR) of the complications between the HW, OWand OB groups was calculated. The rate of conversion to arthroplasty, and 5and 10 years survivorship were recorded, as well as the hazard ratio (HR) of BMI on survivorship. A total of 574 cases were included in the study: the HW group (n = 96), the OW group (n = 233)and the OB group (n = 245), with a mean BMI of 23 ± 1.5 kg/m2, 27.4 ± 1.4 kg/m2 and 34.4 ± 3.8 kg/m2, respectively. The mean follow-up was 13.3 years (4.8-20.3). The mean mechanical tibiofemoral angle corrections were in the HW group: 7.1 ± 3°, OW group: 6.6 ± 3.5°and OB group: 7.1 ± 3.8°, with no intergroup significant difference (p = n.s.). Clinically, despite lower preoperative scores in the OW and OB groups, no difference was observed postoperatively amongst the three groups. The overall complication rate was 12.5% in the HW group, 6.8% in the OW group, and 9.8% in the OB group. There was no significant difference in the RR of complications between the HW and OW groups (RR = 0.6, 95% confidence interval [CI] = 0.3-1.3)(p = 0.2), and the HW and OB groups (RR = 0.8; 95% CI = 0.3-2.2)(p = 0.7). There was no overall significant difference in survival outcomes based on the BMI between the threegroups (p = 0.4). The HR of conversion to arthroplasty between the HW and OW groups was 1.4 [95% CI = 0.6-3.5](p = 0.5)and between the HW and OB groups was 1.8 [95% CI = 0.8-4.4] (p = 0.2). BMI has no significant effect on either the radiological corrections, clinical outcomes, complicationsor survivorship of MOWHTO at short- to medium-term follow-up. No specific cutoff point for BMI can be recommended as a contraindication to MOWHTO. Level IV, Retrospective cohort study.

The Use of Artificial Intelligence Technologies in Cancer Care

Artificial intelligence (AI) is already an essential tool in the handling of large data sets in epidemiology and basic research.Significant contributions to radiological diagnosis are emerging alongside increasing use of digital pathology. The future lies in integrating this information together with clinical data relevant to each individual patient. Linkage with clinical protocols will enable personalized management options to be presented to the oncologist of the future.Radiotherapy has the distinction of being the first to have a National Institute for Health and Care Excellence (NICE)-approved AI-based recommendation. There is the opportunity to revolutionize the workflow with many tasks currently undertaken by clinicians taken over by AI-based systems for volume outlining, planning, and quality assurance.Education and training will be essential to understand the AI processes and inputs. Clinicians will however have to feel confident interrogating the AI-derived information and in communicating AI-derived treatment plans to patients.

Trends in NICE technology appraisals of non-small cell lung cancer drugs over the last decade.

The aim of this study is to analyse the trends in technology appraisals for non-small cell lung cancer (NSCLC) treatments performed by the National Institute for Health and Care Excellence (NICE) over the last ten years. A systematic search was conducted for single technology appraisals of NSCLC drugs in the online NICE database from 2012 to 2022. Search terms used were 'non small cell lung cancer', and 'NSCLC'. Appraisals that were under development or terminated as well as multiple technology appraisals were considered out of scope. In the 30 included appraisals for targeted therapies and immunotherapies within NSCLC, a total of 53 different comparators were included by NICE for 41 assorted indications or subgroups. Partitioned survival models were most frequently used, often including three health states and time horizons of up to 30 years. Throughout the decade the use of indirect comparisons was high and became more established and complex over time. Of all appraisals, 90% positively recommended the treatment for use in the UK. Technology appraisals became more complex over time due to the emergence of targeted therapies and immunotherapies, leading to multiple different indications, subpopulations and comparators that needed to be included in appraisals. Partitioned Survival Analysis (PartSA) models became the cornerstone within NSCLC, with time horizons up to 30 years and over time methods for indirect treatment comparisons became more established. The majority of the appraisals resulted in a positive recommendation for reimbursement.

Discussions about physical activity in general practice: analysis of video-recorded consultations.

Background Clinical guidance recommends promotion of physical activity during general practice consultations. The frequency and content of physical activity discussions in UK general practice are poorly understood. Aim To explore the content of physical activity discussions during routine consultations between patients and general practitioners (GPs). Design and setting Secondary analysis of video-recorded UK general practice consultations from the One in a Million study. Methods We screened 294 consultation transcripts, identifying consultations that included or omitted physical activity advice when recommended by National Institute for Health and Care Excellence (NICE) guidance. We coded the content, quality and depth of advice provided by GPs. Results Physical activity was relevant to management according to clinical guidance in 175/294 (59.5%) consultations. In 64/175 (36.6%) of these consultations physical activity was discussed as part of clinical management and the depth of discussion was judged as 'meaningful' in 22 (12.6%). Whilst physical activity advice tended to be given most often for musculoskeletal problems, depth of advice did not appear to be related to the presenting problem. When physical activity advice was relevant and omitted, consultations prioritised another overriding presenting problem, or clinical management focussed on another intervention. Conclusion Physical activity advice, following national guidance, was potentially relevant to over half of GP consultations; GPs were able to deliver advice of varying depth in a third of these consultations. Future work should explore ways of delivering physical activity advice effectively, efficiently and equitably within the constraints of general practice. Keywords Physical activity; general practice; video recording.

Update on the role of S100B in traumatic brain injury in pediatric population: a meta-analysis.

Cranial computed tomography (CT) scan is the most widely used tool to rule out intracranial lesions after pediatric traumatic brain injury (TBI). However, in pediatric population, the radiation exposure can lead to an increased risk of hematological and brain neoplasm. Defined in 2019 National Institute for Health and Care Excellence (NICE) guidelines as "troponins for the brain", serum biomarkers measurements, particularly S100B, have progressively emerged as a supplementary tool in the management of TBI thanks to their capacity to predict intracranial post-traumatic lesions. This systematic review was conducted following the PRISMA protocol (preferred reporting items for systematic reviews and meta-analyses). No chronological limits of study publications were included. Studies reporting data from children with TBI undergoing serum S100B measurement and computed tomography (CT) scans were included. Of 380 articles screened, 10 studies met the inclusion criteria. Patients admitted with mild-TBI in the Emergency Department (ED) were 1325 (80.25%). The overall pooled sensitivity and specificity were 98% (95% CI, 92-99%) and 45% (95% CI, 29-63%), respectively. The meta-analysis revealed a high negative predictive value (NVP) (99%; 95% CI, 94-100%) and a low positive predictive value (PPV) (41%; 95% CI, 16-79%). Area under the curve (AUC) was 76% (95% CI, 65-85%). The overall pooled negative predictive value (NPV) was 99% (95% CI, 99-100%). The measurement of serum S100B in the diagnostic workflow of mTBI could help informed decision-making in the ED setting, potentially safely reducing the use of CT scan in the pediatric population. The high sensitivity and excellent negative predictive values look promising and seem to be close to the values found in adults. Despite this, it must be pointed out the high heterogeneity (> 90%) found among studies. In order for S100B to be regularly introduced in the pediatric workflow for TBI, it is important to conduct further studies to obtain cut-off levels based on pediatric reference intervals.

Using the behaviour change wheel to develop a tailored intervention to overcome general practitioners’ perceived barriers to referring insomnia patients to digital therapeutic sleepio

BackgroundDigital therapeutic Sleepio has proven effective in improving sleep quality and decreasing symptoms of anxiety. The National Institute for Health and Care Excellence (NICE) guidance recommends Sleepio as an alternative treatment to usual sleep hygiene education and hypnotic medications. General practitioners (GPs) play a critical role in the adoption of digital therapeutics in patient care. Previous interventions did not adopt theoretical frameworks to systematically understand GPs behaviour toward referring patients to digital therapeutics.ObjectivesThis study aimed to report the systematic and comprehensive development of an intervention to encourage GPs to refer insomnia patients to Sleepio, using the Behaviour Change Wheel (BCW).MethodsThe eight steps outlined in the BCW were followed to develop an intervention. The Capability Opportunity Motivation-Behaviour Self-Evaluation Questionnaire (COM-B-Qv1) was adopted to understand GPs perceived facilitators and barriers to refer insomnia patients to Sleepio. The Behaviour Change Technique Taxonomy Version 1 (BCTv1) was thereafter used to identify possible strategies that could be used to facilitate changes in GPs’ behaviour in relation to Sleepio.ResultsThe BCW design process resulted in the identification of five intervention functions, three policy categories and five behaviour change techniques (BCTs) as potential active components for an intervention. The intervention includes providing GPs with an orientation about using Sleepio to improve their knowledge and confidence, sending visual reminders to GPs to recommend Sleepio to their patients, providing ongoing technical support.ConclusionThe BCW can be successfully applied through a systematic process to understand the drivers of GPs’ behaviour and to develop an intervention that can encourage them to refer insomnia patients to Sleepio.

Safety and feasibility of triage and rapid discharge of patients with chest pain from emergency room: A pragmatic, randomized noninferiority control trial of the European Society of Cardiology (ESC) 0 to 1 hour pathway vs conventional 0 to 3 hour accelerated diagnostic protocol

Patients presenting with chest pain represent a significant proportion of Emergency Department (ED) attendances but only a minority, typically 10%, have a final diagnosis of myocardial infarction (MI). Prompt discharge of patients without MI will alleviate ED overcrowding as well as improve patient satisfaction and reduce exposure to risk of hospital acquired infections such as Covid 19.The measurement of cardiac troponin (cTn) by a high sensitivity method is recommended by the National Institute for health and Care Excellence (NICE) for rapid categorisation of patients presenting with chest pain. Strategies proposed include measurement on admission and one hour from admission (ESC 0–1-hour pathway, the recent guideline approved pathway which has not been implemented widely), and measurement on admission and three hours from admission (0–3-hour pathway, which is conventional and widely adopted).The primary objective of this study is twofold: firstly, to assess the safety, feasibility, and impact of implementing the ESC (European Society of Cardiology) 0–1-hour pathway in clinical practice by reference to the more established ESC 0–3-hour protocol. The principal outcome measure will be the safety of the ESC 0–1-hour protocol. However, there are concerns that the time from sample draw to result availability (typically around 60 minutes) will impact on the feasibility of the ESC 0–1-hour pathway. Secondly, therefore, our goal is to evaluate whether measurement of high sensitivity troponin by a bedside analyser (point of care testing, POCT), which will produce results in 15 minutes is a feasible alternative to laboratory testing. We will compare the results produced by POCT with the laboratory results in the context of the ESC 0-1 hour and 0–3-hour pathway, as a nested controlled study in the context of a randomised controlled trial. (clinicaltrials.gov: NCT05322395)

A Practical Approach to Tailor the Term Long COVID for Diagnostics, Therapy and Epidemiological Research for Improved Long COVID Patient Care.

The term long COVID (LC) effectively describes the broad long-term disease burden of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) infections, encompassing individual suffering and significant socioeconomic impacts. However, its general use hampers precise epidemiological research, diagnostics and therapeutic strategies. Misinterpretations occur, for example, when population surveys are compared to studies using health record data, because both refer to these data as LC. This also emphasizes the need for different terminology. The National Institute for Health and Care Excellence (NICE) rapid guideline differentiates ongoing symptomatic COVID-19 from post-COVID conditions, yet real-world observations challenge these two subgroup definitions. We propose refining the term LC into three subgroups: ongoing symptomatic COVID-19, SARS-CoV-2 induced or exacerbated diseases and post-acute COVID condition. This stratification aids targeted diagnostics, treatment and epidemiological research. Subgroup-specific documentation using the International Classification of Diseases, Tenth Revision (ICD-10) codes ensures accurate tracking and understanding of long-term effects. The subgroup of post-acute COVID condition again includes various symptoms, syndromes and diseases like post-exertional malaise (PEM), dysautonomia or cognitive dysfunctions. In this regard, differentiation, especially considering PEM, is crucial for effective diagnostics and treatment.

2229 A review of CT head scans in elderly patients admitted to hospital with falls and adherence to the NICE guidelines.

Abstract Introduction Falls remain the leading reason for elderly people to attend emergency department (ED), which in 2023 led to 250,000 hospital admissions in the UK. A seemingly large number of geriatric patients undergo CT head as an initial workup in ED which might not be necessary, especially in minor head trauma. NICE (National Institute for Health and Care Excellence), recommended risk stratification to reduce unnecessary head scanning which may potentially reduce ED length of stay, hospitalisation and medical expense. Our study evaluated the current practice of adherence to NICE guidance on Head Injury: assessment and early management for performing CT head scans in elderly admitted to Basildon hospital. Methods Two cycles of retrospective data collection were undertaken across three elderly care wards. Elderly patients admitted with falls who had CT head scans were identified. Indication for scanning were evaluated to determine adherence with NICE guidelines for head injury. Between cycles, formal educational sessions were provided to Junior Doctors by departmental teaching and distributing leaflets/posters explaining NICE guidance for indication of CT head scans in head injury. Results Following the interventions implemented, patient compliance to the NICE guidance for undergoing CT head with a history of falls, rose from 77.33% to 93.99%. No significant difference in abnormal CT head findings were demonstrated between cycles. In addition, mortality observed between cycles was near equivalent, 12% and 11.67% respectively. The mean time for CT head scans performed also improved, from 13 hours to 4 hours. Conclusion We demonstrated education regarding the indication for CT head scans in elderly with falls improved the appropriateness of scans performed in accordance with NICE guidance. CT head scans performed which more robustly met NICE guidance demonstrated no difference in adverse findings or patient mortality and may have contributed to reduced mean scan time, thus improving resource allocation.

Getting It Right First Time (GIRFT) – implementation of GIRFT and MedTech Funding Mandate policy around minimally invasive surgery for BPH in the UK

The MedTech Funding Mandate (MTFM) policy was introduced in 2021 by the National Health Service (NHS) England, to facilitate the adoption of innovative, cost-saving medical technologies approved by the National Institute for Health and Care Excellence (NICE) within the NHS. This policy aligns with the objectives of the Getting It Right First Time (GIRFT) initiative, which aims to improve clinical effectiveness by reducing unwarranted variations in healthcare practices. In April 2022, the MTFM policy included four technologies for the treatment of bladder outlet obstruction (BOO). These technologies offer clinical effectiveness, resource efficiency, and affordability, as recommended by NICE. Despite the availability of NICE-approved minimally invasive surgical treatments (MISTs) for BOO, transurethral resection of the prostate (TURP) remains the commonest surgical treatment for BOO, although there is debate as to whether this remains the gold-standard of care. The inclusion of the four BOO technologies in the MTFM policy aims to address the existing inequalities in patient access to NICE-approved treatments and support the adoption of these effective alternatives to monopolar TURP. Key stakeholders, including GIRFT, Urology Area Networks (UANs), and the 15 Academic Science Networks (AHSNs), play a crucial role in implementing the MTFM policy. The policy has significant implications for clinical practice, promoting pathway transformation, resource and cost savings, and a comprehensive range of treatment options for patients with BOO.

Clinical benefit, reimbursement outcomes, and prices of FDA-approved cancer drugs reviewed through Project Orbis in the USA, Canada, England, and Scotland: a retrospective, comparative analysis

Project Orbis is a global initiative that aims to streamline regulatory review processes across international regulators in the USA, Canada, Australia, UK, Israel, Brazil, Singapore, and Switzerland to bring promising cancer drugs to patients earlier. We explored the clinical benefit, time to regulatory approval and health technology assessment recommendations, reimbursement outcomes, and monthly treatment prices of cancer drugs reviewed through this initiative. For this retrospective, comparative analysis, we identified cancer drug approvals reviewed through Project Orbis in the USA, Canada, and the UK between May 1, 2019, and Nov 1, 2023. Approvals of cancer drugs reviewed Project Orbis were extracted from the Food and Drug Administration (FDA) Oncology Centre of Excellence and all other FDA approvals from the Drugs@FDA database. The co-primary outcomes were time of regulatory review, time from regulatory approval to health technology assessment recommendation (England, Scotland, and Canada), reimbursement outcomes, clinical benefit (defined as median gains in progression-free survival and overall survival) between cancer drug approvals reviewed by Project Orbis and other FDA approval processes, and monthly treatment prices. The Wilcoxon rank-sum and Fisher's Exact tests were used to examine statistical significance between approvals reviewed through Project Orbis and other FDA approvals during the same period. Between May 1, 2019 and Nov 1, 2023, 81 (33%) of 244 cancer drugs approved by the FDA were reviewed through Project Orbis. The median overall survival gains were 4·1 months (IQR 3·3-5·1) compared with 2·7 months (2·1-3·9) for other FDA approvals. Similarly, progression-free survival gains were 2·6 months (IQR 1·7-4·9) for Project Orbis compared with 2·6 months (0·6-5·1) for other FDA approvals. Neither overall survival (p=0·11) nor progression-free survival (p=0·44) gains were significantly different between the two cohorts of approvals. Of the 14 UK Medicines and Healthcare products Regulatory Agency (MHRA) approvals reviewed by the Scottish Medicines Consortium (SMC), the agency gave positive recommendations for all 14 (100%). Of the 15 MHRA approvals reviewed by the National Institute for Health and Care Excellence (NICE), the agency gave positive recommendations for six (40%). Of the 49 approvals reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH), the agency conditionally recommended 44 (90%). The time between regulatory approval to NICE recommendation increased from a median of 137 days (IQR 102-172) in 2021 to 302 days (184-483) in 2023, SMC recommendation increased from 185 days (in 2021 for one drug only) to 368 days (IQR 313-476) in 2023, and CADTH decision increased from 97 days (in 2020 for one drug only) to 202 days (IQR 153-304) in 2023. The median monthly price of approvals reviewed through Project Orbis was US$20 000 per month (IQR 13 000-37 000). Clinical outcomes of Project Orbis were no different than other FDA approvals during the same time, and access, after a successful health technology assessment, was considerably delayed or absent, raising questions about whether Project Orbis participation translates into faster patient access to medicines with high clinical benefit and sustainable costs. Although future challenges might benefit from regulatory harmonisation, the advantages are currently unclear. None.

The NICE search filters for treating and managing COVID-19: validation in MEDLINE and Embase (Ovid).

In this paper we report how the United Kingdom's National Institute for Health and Care Excellence (NICE) search filters for treating and managing COVID-19 were validated for use in MEDLINE (Ovid) and Embase (Ovid). The objective was to achieve at least 98.9% for recall and 64% for precision. We did two tests of recall to finalize the draft search filters. We updated the data from an earlier peer-reviewed publication for the first recall test. For the second test, we collated a set of systematic reviews from Epistemonikos COVID-19 L.OVE and extracted their primary studies. We calculated precision by screening all the results retrieved by the draft search filters from a targeted sample covering 2020-23. We developed a gold-standard set to validate the search filter by using all articles available from the "Treatment and Management" subject filter in the Cochrane COVID-19 Study Register. In the first recall test, both filters had 99.5% recall. In the second test, recall was 99.7% and 99.8% in MEDLINE and Embase respectively. Precision was 91.1% in a deduplicated sample of records. In validation, we found the MEDLINE filter had recall of 99.86% of the 14,625 records in the gold-standard set. The Embase filter had 99.88% recall of 19,371 records. We have validated search filters to identify records on treating and managing COVID-19. The filters may require subsequent updates, if new SARS-CoV-2 variants of concern or interest are discussed in future literature.

Sedaconda ACD-S for Sedation with Volatile Anaesthetics in Intensive Care: A NICE Medical Technologies Guidance.

Intensive care unit (ICU) patients receive highly complex care and often require sedation as part of their management. ICU sedation has traditionally been delivered using intravenous (IV) agents due to the impractical use of anaesthetic machines in this setting, which are used to deliver volatile sedation. Sedaconda anaesthetic conserving device (ACD)-S (previously known as AnaConDa-S) is a device which allows for the delivery of volatile sedation via the majority of mechanical ventilators by being inserted in the breathing circuit where the heat and moisture exchanger is normally placed. The National Institute of Health and Care Excellence (NICE), as part of the Medical Technologies Evaluation Programme, considered the potential benefits of using Sedaconda ACD-S compared to standard IV sedation in ICU patients. Here we describe the evidence evaluation undertaken by NICE on this technology, supported by CEDAR. CEDAR considered the evidence present in 21 publications that compared the clinical outcomes of patients receiving Sedaconda ACD-S-delivered sedation and IV sedation, and critiqued the economic model provided by the manufacturer. Clinical expert input during the evaluation process was used extensively to ensure that the relevant clinical evidence was captured and that the economic model was suitable for the UK setting. Due to the uncertainty of the evidence, sensitivity analysis was carried out on the key economic inputs to ensure the reliability of the results. Economic modelling has shown that Sedaconda ACD-S-delivered isoflurane sedation is cost saving on a 30-day horizon compared to IV sedation by £3833.76 per adult patient and by £2837.41 per paediatric patient. Clinical evidence indicated that Sedaconda ACD-S-delivered isoflurane sedation is associated with faster patient wake-up times than standard of care. Consequently, NICE recommended Sedaconda ACD-S as an option for delivering sedation in the ICU setting, but noted that further research should inform whether Sedaconda ACD-S-delivered sedation is of benefit to any particular subgroup of patients.

Prescribing Antibiotics for Children with Acute Conditions in Public Primary Care Clinics in Singapore: A Retrospective Cohort Database Study.

Data on primary care antibiotic prescription practices for children in Singapore, which are essential for health care policy, are lacking. We aimed to address this gap and to benchmark prescription practices against international standards. A retrospective cohort database study on antibiotic prescriptions for children (aged < 18 years) who visited six public primary care clinics in Singapore between 2018 and 2021 was conducted. Data were categorised according to the World Health Organization's Access, Watch, Reserve (WHO AWaRe) classification. Quality indicators from the European Surveillance of Antimicrobial Consumption Network (ESAC-Net) and the National Institute for Health and Care Excellence (NICE) guidelines were used as a measure of appropriateness of antibiotic prescribing at the individual and overall patient level. In 831,669 polyclinic visits by children between 2018 and 2021, there was a significant reduction in mean antibiotics prescribed per month during pandemic years (2020-2021) compared to pre-pandemic (2018-2019) (MD 458.3, 95% CI 365.9-550.7). Most prescriptions (95.8%) for acute conditions fell within the WHO AWaRe "Access" group. Antibiotic prescription significantly exceeded (55.2%) the relevant quality indicator for otitis media (0-20%). The proportion of children receiving appropriate antibiotics for acute respiratory infections (n = 4506, 51.3%) and otitis media (n = 174, 49.4%) was low compared to the quality indicator (80-100%). There is a need to develop local evidence-based primary care antibiotic guidelines, as well as to support the development of stewardship programmes.

Etiology and diagnostic approach of recurrent miscarriage at a reference center in Bucaramanga, Colombia.

The purpose of this study was to determine the etiologies of recurrent miscarriage in our hospital and whether its diagnostic approach followed the recommendations of the American Society of Reproductive Medicine (ASRM) guidelines published in 2012 and the National Institute for Health and Care Excellence (NICE) guidelines published in 2011. This was a retrospective study. The medical records of 158 patients diagnosed with recurrent miscarriage between 2013 and 2018 at Santander University Hospital were reviewed. The Institutional Review Board of HUS approved the study in May 2020. The most common etiologies identified were protein S deficiency, thrombophilia, and cervical insufficiency, with incidence rates of 25.9%, 10.7%, and 3.8%, respectively. Moreover, the most frequently requested diagnostic tests were for protein S, protein C, and anti-phospholipid IgG. Abnormal results for protein S were obtained in 49% of the patients, whereas lupus anticoagulant was abnormal in 12.8%, and Factor V Leiden gene mutations in 8.5% of the patients. Three substantial deviations from the recommended diagnostic approach for recurrent miscarriage by international guidelines were identified in our population: the lack of request for cytogenetic analysis of pregnancy tissue, request for cytogenetic analysis for the parents in only 0.6% of the study sample, and the request for imaging tests to assess uterine anatomy in only 6.3% of the studied population. Both the ASRM and NICE guidelines were only partially followed with a combined adherence rate of 66.5%. The diagnostic approach for recurrent miscarriage poses important clinical challenges when compared to the recommendations of international guidelines. Therefore, the development of a local recurrent miscarriage assessment protocol is proposed in our institution.

Impact of ‘decision-to-delivery’ interval on maternal and perinatal outcomes: a retrospective study of emergency caesarean section from 2017 to 2021 at a secondary health facility in Nigeria

BackgroundThe decision-to-delivery interval (DDI) for a caesarean section is among the factors that reflect the quality of care a pregnant woman receives and the impact on maternal and foetal outcomes and should not exceed 30 min especially for Category 1 National Institute for Health and Care Excellence (NICE) guidelines. Herein, we evaluated the effect of decision-to-delivery interval on the maternal and perinatal outcomes among emergency caesarean deliveries at a secondary health facility in north-central Nigeria.MethodsWe conducted a four-year retrospective descriptive analysis of all emergency caesarean sections at a secondary health facility in north-central Nigeria. We included pregnant mothers who had emergency caesarean delivery at the study site from February 10, 2017, to February 9, 2021.ResultsOut of 582 who underwent an emergency caesarean section, 550 (94.5%) had a delayed decision-to-delivery interval. The factors associated with delayed decision-to-delivery interval included educational levels (both parents), maternal occupation, and booking status. The delayed decision-to-delivery interval was associated with an increase in perinatal deaths with an odds ratio (OR) of 6.9 (95% CI, 3.166 to 15.040), and increased odds of Special Care Baby Unit (SCBU) admissions (OR 9.8, 95% CI 2.417 to 39.333). Among the maternal outcomes, delayed decision-to-delivery interval was associated with increased odds of sepsis (OR 4.2, 95% CI 1.960 to 8.933), hypotension (OR 3.8, 95% 1.626 TO 9.035), and cardiac arrest (OR 19.5, 95% CI 4.634 to 82.059).ConclusionThis study shows a very low optimum DDI, which was associated with educational levels, maternal occupation, and booking status. The delayed DDI increased the odds of perinatal deaths, SCBU admission, and maternal-related complications.

Lumbar spine fusion surgery versus best conservative care for patients with severe, persistent low back pain.

People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians' views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial). An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials. There were 72 respondents, with a response rate of 9.0%. They comprised 39 orthopaedic spine surgeons, 17 neurosurgeons, one pain specialist, and 15 allied health professionals. Most respondents (n = 61,84.7%) chose conservative care as their first-choice management option for all five case vignettes. Over 50% of respondents reported willingness to randomize three of the five cases to either surgery or BCC, indicating a willingness to participate in the future randomized trial. From the respondents, transforaminal interbody fusion was the preferred approach for spinal fusion (n = 19, 36.4%), and the preferred method of BCC was a combined programme of physical and psychological therapy (n = 35, 48.5%). This survey demonstrates that there is uncertainty about the role of lumbar spine fusion surgery and BCC for a range of example patients with severe, persistent LBP in the UK.