Early Advice Research Articles

Children and Young People’s Mental Health Practitioner: A pilot evaluation

New roles have been developed to meet increased demands for children and young people’s (CYP) mental health support. In 2017, Children’s Wellbeing Practitioners (CWP) and Education Mental Health Practitioners (EMHP) psychological professions’ training programmes were introduced. A new Children & Young People’s Mental Health Practitioner (CYP-MHP) role has now been piloted with the aim of improving access to CYP mental health support through early intervention, providing psychoeducation, advice and signposting. This pilot provides a new service; CWP/EMHP require training and deliver therapy, whereas CYP-MHP provides a triage/assessment therapeutic service and does not require NHS-funded training. Outcomes of the pilot evaluation demonstrate a place for this role in primary care, where there existed a gap before.

The ESMO Tumour-Agnostic Classifier and Screener (ETAC-S): a tool for assessing tumour-agnostic potential of molecularly guided therapies and for steering drug development

Advances in precision oncology led to approval of tumour-agnostic molecularly guided treatment options (MGTOs). The minimum requirements for claiming tumour-agnostic potential remain elusive. The European Society for Medical Oncology (ESMO) Precision Medicine Working Group (PMWG) coordinated a project to optimise tumour-agnostic drug development. International experts examined and summarised the publicly available data used for regulatory assessment of the tumour-agnostic indications approved by the US Food and Drug Administration and/or the European Medicines Agency as of December 2023. Different scenarios of minimum objective response rate (ORR), number of tumour types investigated, and number of evaluable patients per tumour type were assessed for developing a screening tool for tumour-agnostic potential. This tool was tested using the tumour-agnostic indications approved during the first half of 2024. A taxonomy for MGTOs and a framework for tumour-agnostic drug development were conceptualised. Each tumour-agnostic indication had data establishing objective response in at least one out of five patients (ORR ≥ 20%) in two-thirds (≥4) of the investigated tumour types, with at least five evaluable patients in each tumour type. These minimum requirements were met by tested indications and may serve as a screening tool for tumour-agnostic potential, requiring further validation. We propose a conceptual taxonomy classifying MGTOs based on the therapeutic effect obtained by targeting a driver molecular aberration across tumours and its modulation by tumour-specific biology: tumour-agnostic, tumour-modulated, or tumour-restricted. The presence of biology-informed mechanistic rationale, early regulatory advice, and adequate trial design demonstrating signs of biology-driven tumour-agnostic activity, followed by confirmatory evidence, should be the principles for tumour-agnostic drug development. The ESMO Tumour-Agnostic Classifier (ETAC) focuses on the interplay of targeted driver molecular aberration and tumour-specific biology modulating the therapeutic effect of MGTOs. We propose minimum requirements to screen for tumour-agnostic potential (ETAC-S) as part of tumour-agnostic drug development. Definition of ETAC cut-offs is warranted.

Who is to put the bell on the cat? Democracy, dictatorship, and James M. Buchanan's early 1980s involvement with Pinochet's Chile

AbstractAlthough Milton Friedman's mid‐1970s involvement with Pinochet's Chile has generated much controversy, the claim that James M. Buchanan was similarly eager to provide Pinochet's military dictatorship with early 1980s policy advice is increasingly reported as an established fact in the vast scholarly literature on neoliberalism. This article invokes a wealth of previously ignored primary source material that sheds significant new light on Buchanan's early 1980s involvement with Chile. In particular, we evaluate whether Buchanan's May 1980 visit to Chile was an integral part of the Pinochet junta's late 1970s and early 1980s efforts to draft a new constitution. Similarly, we evaluate whether Buchanan's ideas had any significant influence on the views of Pedro Ibáñez and Carlos Cáceres (the most anti‐democratic members of Pinochet's Council of State and the primary hosts of Buchanan's May 1980 visit to Chile). Finally, we shed important new light on Buchanan's participation in the highly controversial late 1981 Mont Pèlerin Society meeting in Chile.

Characterization of Erwinia amylovora isolates from the northern region of Saudi Arabia, including CRISPR genotyping

AbstractFire blight, caused by the bacterium Erwinia amylovora, poses a global threat to the pome fruit industry, leading to reduced yields and significant economic losses. A comprehensive countrywide survey was carried out to determine the possible E. amylovora distribution in pome fruit‐growing regions. During the period 2020–2023, 85 isolates characteristic of E. amylovora were obtained from pear across 23 locations in three main pear‐producing regions (Al‐Jouf, Hail and Tabuk) in northern Saudi Arabia (SA). Isolates were identified using biochemical, molecular and pathogenicity assays. Molecular characterization of Saudi strains was achieved using partial 16S rRNA and rpoB gene sequencing, rep‐PCR (specifically, BOX‐PCR) and CRISPR array analysis. The CRISPR genotyping in particular, using an existing scheme of three CRISPR arrays, CR1, CR2 and CR3, provided consistent patterns of the Saudi isolates with high similarity to those of E. amylovora strains from the UK and France, hinting at a possible origin of the fire blight infections from these countries. Some variation was observed in patterns between local strains, highlighting the importance of continued surveillance and genetic studies for effective disease management strategies. Identification of fire blight in three regions over several years should serve as a warning to the Ministry of Environment, Water and Agriculture in Saudi Arabia, prompting the initiation of a more comprehensive survey and an active disease management programme. This programme should include early detection and advice to growers on prevention and control measures. This is the first scientific study on the occurrence and genetic variability of E. amylovora in Saudi Arabia.

Prevalence of oral papillomas in Brazilian children: a retrospectivestudy of biopsied lesions

Introduction: Human papillomavirus (HPV) is an etiologic factor for several diseases of the oralmucosa and skin that can undergo a malignant process. Vaccination is the most important form of prevention, with girls being vaccinated between the ages of 9 and 13 and boys between the ages of 11 and 13. There is still no consensus on the prevalence of the HPV virus in children. Aim: To review the prevalence of HPV in children aged 1 to 13 years based on a database of reports of biopsied lesions diagnosed with papilloma analyzed in a national reference laboratory. Material and methods: Anatomic-pathologic reports of biopsies received at the Oral and Maxillofacial Pathology Laboratory of the Faculty of Dentistry of the College of São Paulo were analyzed over a 20-year period, between 2002 and 2022. Information on gender, lesion location and diagnostic hypotheses was also collected. Results: In a database of 93,950 reports, the age group analyzed accounted for 4,203 and 99 (2.3%) were diagnosed with papilloma. The proportion of male and female reports was similar at 50.5% and 49.5% respectively. The most common location of the lesion found was the lip region (48%). The most frequently cited diagnostic hypotheses were epulis and verruca vulgaris. Conclusion: The prevalence of papillomas in Brazilian children aged 1 to 13 years was 2.3%. Early diagnosis and advice on HPV vaccination can prevent and avoid exacerbation of the disease. Recognizing the clinical features of lesions is essential for correct diagnosis and early intervention and counseling.

How can health technology assessment be improved to optimise access to medicines? Results from a Delphi study in Europe

IntroductionAccess to medicines is a shared goal across healthcare stakeholders. Since health technology assessment (HTA) informs funding decisions, it shapes access to medicines. Despite its wide implementation, significant access variations due to HTA are observed across Europe. This paper elicited the opinions of European stakeholders on how HTA can be improved to facilitate access.MethodsA scoping review identified HTA features that influence access to medicines within markets and areas for improvement, while three access dimensions were identified (availability, affordability, timeliness). Using the Delphi method, we elicited the opinions of European stakeholders to validate the literature findings.ResultsNineteen participants from 14 countries participated in the Delphi panel. Thirteen HTA features that could be improved to optimise access to medicines in Europe were identified. Of these, 11 recorded a positive impact on at least one of the three access dimensions. HTA features had mostly a positive impact on timeliness and a less clear impact on affordability. ‘Early scientific advice’ and ‘clarity in evidentiary requirements’ showed a positive impact on all access dimensions. 'Established ways to deal with uncertainty during HTA’ could improve medicines’ availability and timeliness, while more ‘reliance on real-world evidence’ could expedite time to market access.ConclusionsOur results reiterate that increased transparency during HTA and the decision-making processes is essential; the use of and reliance on new evidence generation such as real-world evidence can optimise the availability of medicines; and better collaborations between regulatory institutions within and between countries are paramount for better access to medicines.

A machine learning-based score for precise echocardiographic assessment of cardiac remodelling in hypertensive young adults.

Accurate staging of hypertension-related cardiac changes, before the development of significant left ventricular hypertrophy, could help guide early prevention advice. We evaluated whether a novel semi-supervised machine learning approach could generate a clinically meaningful summary score of cardiac remodelling in hypertension. A contrastive trajectories inference approach was applied to data collected from three UK studies of young adults. Low-dimensional variance was identified in 66 echocardiography variables from participants with hypertension (systolic ≥160 mmHg) relative to a normotensive group (systolic < 120 mmHg) using a contrasted principal component analysis. A minimum spanning tree was constructed to derive a normalized score for each individual reflecting extent of cardiac remodelling between zero (health) and one (disease). Model stability and clinical interpretability were evaluated as well as modifiability in response to a 16-week exercise intervention. A total of 411 young adults (29 ± 6 years) were included in the analysis, and, after contrastive dimensionality reduction, 21 variables characterized >80% of data variance. Repeated scores for an individual in cross-validation were stable (root mean squared deviation = 0.1 ± 0.002) with good differentiation of normotensive and hypertensive individuals (area under the receiver operating characteristics 0.98). The derived score followed expected hypertension-related patterns in individual cardiac parameters at baseline and reduced after exercise, proportional to intervention compliance (P = 0.04) and improvement in ventilatory threshold (P = 0.01). A quantitative score that summarizes hypertension-related cardiac remodelling in young adults can be generated from a computational model. This score might allow more personalized early prevention advice, but further evaluation of clinical applicability is required.

Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications

IntroductionPromptly providing new drugs to fulfill unmet medical needs requires changes in drug development and registration processes. Health Authorities (HAs) considered as reference due to their experience and acknowledgement (Food and Drug Administration [FDA] among others) already consider innovative clinical trial (CT) designs and flexible approval procedures, but Latin America (LATAM) regulations are still far. A comparison was performed to identify gaps.Materials and MethodsCT requirements for drug Marketing Authorization Application (MAA) and CT approval regulations were compared between LATAM and reference HAs (FDA/European Medicines Agency [EMA]/Health-Canada/Swissmedic/Therapeutic Goods Administration [TGA]/Pharmaceuticals and Medical Devices Agency [PMDA]), as of August 2022. Procedure included reference HAs regulations review, item selection, identification in LATAM regulations, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (ICH-E6[R2]/ICH-E8[R1]) implementation revision.ResultsFor MAA, specific application requirements or ICH guideline M4(R4) on common technical document (CTD) adoption are generally stated, and phase-I/III performance is mandatory (explicitly/implicitly). Faster patient access procedures are infrequent: Priority-drug programs, conditional authorizations, or expedited procedures are scarce or non-existent. Regulatory reliance procedures are adopted through different pathways. Regarding CT approval, innovative/complex CT designs are not prohibited but usually omitted. Some countries implemented adapted CT conducting during the COVID-19 pandemic. Early scientific advice meetings (HA-sponsor) are occasionally considered. Most countries are not formally ICH-joined.ConclusionsLATAM regulations must adapt to new regulatory standards (FDA/EMA/ICH) through implementation of frequent updates, reliance/expedited procedures, early HA-sponsor interactions, innovative/complex CTs, mandatory phase-III reaching elimination, and decentralized elements for CT conducting.

Viewpoint: Are you ready to challenge the status quo?

Kate Wise argues that it's time for engineers to take a more proactive approach and seek to offer early input and advice to clients.

Let’s talk early labour: The L-TEL randomised controlled trial

BackgroundWomen without complications have lower obstetric intervention if they remain at home in early labour but many women report dissatisfaction in doing this. Using self-efficacy theory as an underpinning framework, a web-based intervention was co-created with women who had previously used maternity services. The intervention provides early labour advice, alongside the videoed, real experiences of women. MethodThe pragmatic, randomised control trial aimed to evaluate the impact of the web-based intervention on women’s self-reported experiences of early labour. Low-risk, nulliparous, pregnant women (140) were randomised. The intervention group (69) received the web-based intervention antenatally to use at their own convenience and the control group (71) received usual care. Data were collected at 7–28 days postnatally using an online version of the Early Labour Experience Questionnaire (ELEQ). The primary outcome was the ELEQ score. Secondary, clinical outcomes such as labour onset, augmentation and mode of birth were collected from the existing hospital system. ResultsThere were no statistically significant differences in the ELEQ scores between trial arms. Women in the intervention group were significantly more likely to progress spontaneously in labour without the need for labour augmentation (39.1 %) compared to the control group (21.1 %) (OR 2.41, CI 95 %; 1.14–5.11). ConclusionAlthough the L-TEL Trial found no statistically significant differences in the primary outcome, the innovative intervention to support women during latent phase labour was positively received by women. Web-based resources are a cost effective, user-friendly and accessible way to provide women with education. A larger trial is needed to detect differences in clinical outcomes.

The role of the clinical psychologist within a cleft service.

Clinical psychologists are core members of UK cleft services. This paper outlines the variety of ways in which clinical psychologists work across the lifespan to promote the psychological wellbeing of those born with a cleft and their families. In the context of dental or orthodontic treatment, this involves a combination of early intervention and advice, psychological assessment or specialist psychological therapy for individuals experiencing dental anxiety or anxiety regarding the appearance of their teeth. This paper therefore aims to highlight the varying roles which clinical psychologists play in the provision of cleft-related dental care, often alongside multidisciplinary colleagues.

HTA102 Early Scientific Advice in Europe: An Overview of Processes and Requirements

Early scientific advice comprises a systematic process through which national Health Technology Assessment (HTA) bodies provide manufacturers with guidance on their clinical development strategy, aiming to improve the quality of evidence to be submitted. The purpose of this study was to describe the main features characterizing these procedures in scope European countries.

MT30 Medtech Innovations in Oncology: A Review of NICE Medtech Innovation Briefings from 2014 to 2022

Medtech Innovation Briefings (MIBs) are early advice published by the U.K. National Institute for Health and Care Excellence (NICE) to provide rapid information on innovative technologies and assist decision-making by physicians and policymakers. We evaluate trends in MIBs in oncology since its inception in 2014.

Oral Microbiome Traits of Type 1 Diabetes and Phenylketonuria Patients in Latvia.

Some metabolic disorder treatments require patients to follow a specific diet or to consume supplements that, over time, can lead to oral microbiome alterations. Well-known disorders requiring such treatment are phenylketonuria (PKU), an inborn error of amino acid metabolism, and type 1 diabetes (T1D), a metabolic disorder that requires a specific diet regimen. Therefore, the aim of this study was to investigate the oral health and microbiome characteristics that might contribute to caries activity and periodontal disease risk in PKU and T1D patients. In this cross-sectional study, 45 PKU patients, 24 T1D patients, and 61 healthy individuals between the ages of 12 and 53 years were examined. Their anamnestic data and dental status were assessed by one dentist. Microbial communities were detected from saliva-isolated DNA using 16S rRNA gene V3-V4 sequencing on Illumina MiSeq sequencing platform. Results revealed that the PKU patient group displayed the highest number of extracted teeth (on average 1.34), carious teeth (on average 4.95), and carious activity (44.44% of individuals) compared to the T1D and CTRL groups. The lowest numbers of filled teeth (on average 5.33) and extracted teeth (on average 0.63) per individual were observed in T1D patients. Gingivitis appeared more often in the T1D group; however, possible risk of periodontal disease was seen in both the T1D and PKU patient groups. The highest number of differentially abundant genera was detected in the PKU group (n = 20), with enrichment of Actinomyces (padj = 4.17 × 10-22), Capnocytophaga (padj = 8.53 × 10-8), and Porphyromonas (padj = 1.18 × 10-5) compared to the CTRL group. In conclusion, the dental and periodontal health of PKU patients was found to be significantly inferior compared to T1D patients and healthy controls. T1D patients showed early signs of periodontal disease. Several genera that correlate with periodontal disease development were found in both groups, thus suggesting that T1D and PKU patients should seek early and regular dental advice and be educated about proper oral hygiene practices.

The lived experience of prostate cancer: 10-year survivor perspectives following contemporary treatment of localized prostate cancer.

Studies relying on standardized instruments to measure patient-centered harms and benefits of cancer treatment may fail to capture important elements of the lived experience of cancer patients. Further, qualitative studies on the survivorship experience of men with localized prostate cancer (PCa) are limited. We sought to explore the early experience, long-term experience, and advice provided for others among long-term survivors of localized PCa. Semi-structured qualitative interviews with a subset (n = 66) of respondents to a survey of 10-year PCa survivors who underwent active surveillance, radical prostatectomy, or radiotherapy. Topics included early and long-term experiences and advice to other men and physicians. Immediately after treatment, men were mostly satisfied with radiation and active surveillance due to remaining whole and avoiding surgical removal of the prostate. Meanwhile, men treated with surgery felt relieved by the removal of cancer. Some early negative perception was related to short-term anxiety, particularly among men who underwent active surveillance. Long-term experiences included accepting the trade-offs of urinary and sexual side effects with survival. Most men fared well financially, some had strengthened relationships, and many reported greater appreciation and compassion. Men provided essential advice to other men and physicians on the importance of gathering detailed information on treatments and establishing a strong relationship with physicians. Long-term survivors of localized PCa generally do well by accepting the long-term effects of contemporary treatments, experiencing strengthened relationships, and developing a better overall life approach. We provide useful perspectives and insights for men opting to use current-day treatments for localized PCa.

The UK Health Security Agency (UKHSA) Planning, Preparation, and Response to the Birmingham 2022 Commonwealth Games–Learning for Future Mass Gatherings, Including Multi-sport Events

Introduction:The Birmingham 2022 Commonwealth Games (CWG) met the World Health Organization (WHO) definition of a mass gathering: events attended by sufficient people to strain the planning and response resources of a community, state or nation’. It was a key opportunity for the UK in terms of tourism and economy, but a major challenge in terms of the potential for adverse events e.g. infectious disease outbreaks, terrorist attacks. This increased scrutiny and threatened reputational risk. For UKHSA, as a new organization amidst a rapidly changing public health landscape–continued COVID-19 pandemic and increases in Monekypox, this was a very public test.Method:In 2021, a small team was established to accelerate preparation including: assurance structuresadvice to the Organizing Committee and Government departmentsadvice on COVID-19 including testing policystaff/stakeholder preparation through exercising/trainingincreased staff numbers and skill mix able to adaptbudgetoperational response structureplans in place and tested for a health protection response in the event of an incidentother mass gatherings reviewed for transferable learning enhanced surveillance systemsResults:Daily epidemiology reporting provided reassurance that there were no significant public health issues requiring escalation. Enhanced surveillance provided reassurance to the community that there were no population ill effects linked to the CWG. Overall, COVID-19 positivity was low. No outbreaks were detected linked to the CWG.Conclusion:The UKHSA successfully identified, planned and prepared for and mitigated the risks of a mass gathering of 1.5 million people. Early engagement, support, advice and cross- government collaboration has been regarded as exemplary with surveillance data indicating no outbreaks linked to the Games. Despite the breadth of risks visitors were able to attend the event in contrast to the restrictions placed at the Tokyo Olympics. This contributes to the worldwide body of knowledge for planning and delivering mass gatherings – sporting or otherwise.

CLINICAL AND ETIOLOGICAL STUDY OF LOWER EXTREMITY ULCER CASES

Background:Because of their chronic nature, lower extremity ulcers are the most frequent in our population. By maintaining an upright position, the lower extremities are vulnerable to damage and have their circulation strained. This has implications for researchers and surgeons who have been worried about the causes of their prevalent incidence and the difficulties in curing them. A researcher is looking at the causes of lower extremity ulcers. Methods:During the study period, 50 patients with various forms of lower extremity ulcers were admitted to the surgical ward. The instances were extensively studied and evaluated in depth. If a clinically dubious case existed, the diagnosis was determined only after histological testing. Results:Venous 13 (26%) instances were detected in the present, with male (10) and female (3) contributions. The majority of cases (47%) are males between the ages of 41 and 60 years.High saphenous vein ligation with vein stripping (23%) and conservative (15%) therapy was the most prevalent surgical methods utilised to treat Venous ulcers. Conclusions:Venous ulcers are the most common kind of leg ulcer today, with the highest morbidity. At various levels, the surgical procedures try to prevent venous reflux.Interdisciplinary management of patients with ulcers, educating patients on foot care and the importance of seeking early medical advice.

Hubungan Bimbingan Perkawinan Pranikah dengan Tingginya Angka Penceraian:

&#x0D; The decision number of the Director General of Islamic Guidance Long term 2018 on the Execution of Early Marriage Mentoring plans to both Diminish the Quantity of Separations and Make a Cheerful and Tranquil Family. However, the annual divorce rate in Medan continues to rise. In accordance with the Director General of Islamic Guidance's decision No. 379 of 2018 in the KUA of Medan, as well as the results of carrying out early advice in light of the decision made by the chief general of Islamic Direction No. 379 in 2018 to decrease the divorce rate in Medan. Qualitative (empirical) field research was used in this study. The study came to the conclusion that premarital counseling isn't as effective as it should be; Instead, many married couples take a marriage certificate course. It was thought that couples who wanted to get married needed to show a proof certificate to get premarital counseling. Additionally, only the authority to provide premarital counseling and mediation services to couples filing for divorce with the Religious Court ought to be granted by the government to KUA.&#x0D; Keywords: Divorce, KUA, premarital counseling, and Medan

Early Cultivation Advice

The Major Gifts ReportVolume 25, Issue 4 p. 7-7 Briefs Early Cultivation Advice First published: 06 March 2023 https://doi.org/10.1002/mgr.32123Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume25, Issue4April 2023Pages 7-7 RelatedInformation

Barriers and challenges to police and Crown Prosecution Service joint working on rape and serious sexual offence cases: A police perspective

Abstract There is scant academic research on the challenges encountered by the police when working with the Crown Prosecution Service on rape and serious sexual offence cases; yet this relationship plays a crucial part in improving appropriate case outcomes. This qualitative study aims to further knowledge in this area, using interview data from 50 police officers from four forces across England and Wales, analysed using thematic analysis. Four main challenges with police/CPS working were found: (i) poor communication and relationships, exacerbated by a reliance on electronic systems; (ii) not obtaining early advice; (iii) the CPS driving victim-focused investigations; and (iv) issues with DG6 and disclosure. However, areas of good practice were also found, including: early advice clinics; enhanced early advice; joint police/CPS training/meetings; case progression trackers; and discussions regarding reasonable lines of inquiry.