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Background Methods Results Conclusions Autistic children can experience mental health, social and emotional difficulties. Carol Gray's Social Stories™ are a highly personalised intervention that provide social information in a short individually tailored story.A multi‐site pragmatic cluster randomised controlled trial to evaluate the clinical and cost‐effectiveness of Social Stories™ alongside care as usual in autistic children aged 4–11 years. The primary outcome was the Social Responsiveness Scale‐2 completed by teachers 6 months post‐randomisation, analysed on an intention‐to‐treat basis. Trial Registration: ISRCTN11634810.Eighty‐seven schools, including 249 children, were randomised (intervention 44 schools with 129 children, and usual care 43 schools with 120 children). After 6 months, a reduction of 1.61 points was found on the Social Responsiveness Scale‐2 in the intervention group (95% CI −4.18 to 0.96, p = .220) and for those who attended at least six sessions a reduction of 3.37 points (CACE 95% CI −6.65 to −0.10, p = .043). Children in the intervention group met their individual socio‐emotional goal more frequently than children receiving usual care alone and this was statistically significant. No statistically significant differences were found in other secondary outcomes including anxiety, depression, general health or parental stress.Social Stories™ represent a low‐cost, low‐burden intervention. Benefits are seen in individual socio‐emotional goals but without clinically evident impact on social responsiveness, anxiety, depression, parental stress or general health. [ABSTRACT FROM AUTHOR]

Background: In BRAF-mutated high-risk melanoma, targeted therapy (BRAF/MEK inhibitors) and checkpoint inhibitor (CPI) immunotherapy have durable benefits as first-line (1L) adjuvant therapy. Based on differing action mechanisms of BRAF/MEK inhibitors and CPI immunotherapies, there is interest in evaluating the activity of 2L adjuvant targeted therapy in decreasing the risk of subsequent recurrence after repeat resection following relapse on/after 1L adjuvant CPI., Patients and Methods: This was a retrospective review of BRAF V600-mutated resected stage III/IV melanoma patients in the United States, Australia, and The Netherlands who received 1L adjuvant CPI immunotherapy, relapsed locoregionally/distantly, were again resected to no evidence of disease, and received dabrafenib/trametinib (dab/tram) as 2L adjuvant therapy. The primary endpoint was relapse-free survival (RFS) from initiation of 2L adjuvant dab/tram (RFS-2), analyzed via Kaplan-Meier methods., Results: Thirty-eight patients were included (median age 50 years, 63% male, 87% stage III, median follow-up 19 months from 2L dab/tram initiation). Median dab/tram duration was 10.1 months (range: 1 day-22.7 months), with half discontinuing due to progression or adverse events. Median (95% CI) RFS-2 was 18.9 (14.9-28.1) months, with 91%, 81%, and 58% remaining relapse-free at 6, 12, and 18 months, respectively. Most patients remained distant metastasis-free at 6, 12, and 18 months (97%, 85%, and 71%, respectively). Two patients were deceased at the last follow-up, with 97% alive at 18 months., Conclusions: Over 80% of patients remained relapse- and metastasis-free at 12 months after 2L dab/tram initiation, with only 2 deaths observed. Dab/tram appears to have activity in the 2L adjuvant setting, although more follow-up is required., (© The Author(s) 2024. Published by Oxford University Press.)

Background: Metadata describe and provide context for other data, playing a pivotal role in enabling findability, accessibility, interoperability, and reusability (FAIR) data principles. By providing comprehensive and machine-readable descriptions of digital resources, metadata empower both machines and human users to seamlessly discover, access, integrate, and reuse data or content across diverse platforms and applications. However, the limited accessibility and machine-interpretability of existing metadata for population health data hinder effective data discovery and reuse., Objective: To address these challenges, we propose a comprehensive framework using standardized formats, vocabularies, and protocols to render population health data machine-readable, significantly enhancing their FAIRness and enabling seamless discovery, access, and integration across diverse platforms and research applications., Methods: The framework implements a 3-stage approach. The first stage is Data Documentation Initiative (DDI) integration, which involves leveraging the DDI Codebook metadata and documentation of detailed information for data and associated assets, while ensuring transparency and comprehensiveness. The second stage is Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) standardization. In this stage, the data are harmonized and standardized into the OMOP CDM, facilitating unified analysis across heterogeneous data sets. The third stage involves the integration of Schema.org and JavaScript Object Notation for Linked Data (JSON-LD), in which machine-readable metadata are generated using Schema.org entities and embedded within the data using JSON-LD, boosting discoverability and comprehension for both machines and human users. We demonstrated the implementation of these 3 stages using the Integrated Disease Surveillance and Response (IDSR) data from Malawi and Kenya., Results: The implementation of our framework significantly enhanced the FAIRness of population health data, resulting in improved discoverability through seamless integration with platforms such as Google Dataset Search. The adoption of standardized formats and protocols streamlined data accessibility and integration across various research environments, fostering collaboration and knowledge sharing. Additionally, the use of machine-interpretable metadata empowered researchers to efficiently reuse data for targeted analyses and insights, thereby maximizing the overall value of population health resources. The JSON-LD codes are accessible via a GitHub repository and the HTML code integrated with JSON-LD is available on the Implementation Network for Sharing Population Information from Research Entities website., Conclusions: The adoption of machine-readable metadata standards is essential for ensuring the FAIRness of population health data. By embracing these standards, organizations can enhance diverse resource visibility, accessibility, and utility, leading to a broader impact, particularly in low- and middle-income countries. Machine-readable metadata can accelerate research, improve health care decision-making, and ultimately promote better health outcomes for populations worldwide., (©David Amadi, Sylvia Kiwuwa-Muyingo, Tathagata Bhattacharjee, Amelia Taylor, Agnes Kiragga, Michael Ochola, Chifundo Kanjala, Arofan Gregory, Keith Tomlin, Jim Todd, Jay Greenfield. Originally published in the Online Journal of Public Health Informatics (https://ojphi.jmir.org/), 01.08.2024.)

Background: The completion of case-based surveillance forms was vital for case identification during COVID-19 surveillance in Malawi. Despite significant efforts, the resulting national data suffered from gaps and inconsistencies which affected its optimal usability. The objectives of this study were to investigate the processes of collecting and reporting COVID-19 data, to explore health workers' perceptions and understanding of the collection tools and processes, and to identify factors contributing to data quality., Methods: A total of 75 healthcare professionals directly involved in COVID-19 data collection from the Malawi Ministry of Health in Lilongwe and Blantyre participated in Focus Group Discussions and In-Depth Interviews. We collected participants' views on the effectiveness of surveillance forms in collecting the intended data, as well as on the data collection processes and training needs. We used MAXQDA for thematic and document analysis., Results: Form design significantly influenced data quality and, together with challenges in applying case definitions, formed 44% of all issues raised. Concerns regarding processes used in data collection and training gaps comprised 49% of all the issues raised. Language issues (2%) and privacy, ethical, and cultural considerations (4%), although mentioned less frequently, offered compelling evidence for further review., Conclusions: Our study highlights the integral connection between data quality and the design and utilization of data collection forms. While the forms were deemed to contain the most relevant fields, deficiencies in format, order of fields, and the absence of an addendum with guidelines, resulted in large gaps and errors. Form design needs to be reviewed so that it appropriately fits into the overall processes and systems that capture surveillance data. This study is the first of its kind in Malawi, offering an in-depth view of the perceptions and experiences of health professionals involved in disease surveillance on the tools and processes they use., Competing Interests: No competing interests were disclosed., (Copyright: © 2024 Taylor A et al.)

Background: Anti-PD-1 antibodies and BRAK/MEK inhibitors (BRAF/MEKi) reduce the risk of recurrence for patients with resected stage III melanoma. BRAFV600-mutated (BRAFmut) melanoma patients who recur with isolated disease following adjuvant therapy may be suitable for 'second adjuvant' treatment after local therapy. We sought to examine the efficacy and safety of 'second adjuvant' BRAF/MEKi., Patients and Methods: Patients with BRAFmut melanoma treated with adjuvant PD-1 based immunotherapy who recurred, underwent definitive local therapy and were then treated with adjuvant BRAF/MEKi were identified retrospectively from 13 centres (second adjuvant group). Demographics, disease and treatment characteristics and outcome data were examined. Outcomes were compared to BRAFmut patients who did not receive 'second adjuvant' therapy (no second adjuvant group)., Results: 73 patients were included; 61 who received 'second adjuvant' therapy and 12 who did not. Most initially recurred on PD-1 therapy (66%). There were no differences in characteristics between groups. 92% of second adjuvant group received dabrafenib and trametinib and median duration of therapy was 11.8 months (0.4, 34.5). 72% required dose adjustments, 23% had grade 3 + toxicity and 38% permanently discontinued drug due to toxicity. After median 26.1 months (1.9, 56.3) follow-up, recurrence-free survival (RFS) was improved in second adjuvant group versus no second adjuvant group (median 30.8 vs 4 months, HR 0.35; p = 0.014), largely driven by a delay in early recurrence, with no difference in overall survival (p = 0.59)., Conclusion: This is the first study examining outcomes of 'second adjuvant' targeted therapy for melanoma, after failure of adjuvant PD-1 based immunotherapy. Data suggest a short-term improvement in RFS, but at the cost of toxicity. Alternative strategies and more data on sequencing adjuvant therapies are required to improve outcomes., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Disclosures: AMM has served on advisory boards for BMS, MSD, Novartis, Roche, Pierre-Fabre. DBJ has served on advisory boards or as a consultant for BMS, Catalyst Biopharma, Iovance, Mallinckrodt, Merck, Mosaic ImmunoEngineering, Novartis, Oncosec, Pfizer, Targovax, and Teiko, and has received research funding from BMS and Incyte. LZ declares speakers and advisory board honoraria from Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre, Sanofi, Sunpharma, research support from Novartis and travel support from Merck Sharp & Dohme, Bristol-Myers Squibb, Pierre Fabre, Sanofi, Sunpharma and Novartis; outside the submitted work. CH reports speaker and advisory board honoraria from Almirall, BMS, MSD, Novartis, Pierre Fabre Regeneron, Roche, Sanofi Aventis. GVL is consultant advisor for Agenus, Amgen, Array Biopharma, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Evaxion, Hexal AG (Sandoz Company), Highlight Therapeutics S.L., Innovent Biologics USA, Merck Sharpe & Dohme, Novartis, OncoSec, PHMR Ltd, Pierre Fabre, Provectus, Qbiotics, Regeneron. PAA has/had a consultant/advisory role for Bristol Myers Squibb, Roche-Genentech, Merck Sharp & Dohme, Novartis, Merck Serono, Pierre-Fabre, AstraZeneca, Sun Pharma, Sanofi, Sandoz, Immunocore, Italfarmaco, Nektar, Boehringer-Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Pfizer, Oncosec, Nouscom, Lunaphore, Seagen, iTeos, Medicenna, Bio-Al Health, ValoTX, Replimmune, Bayer, Erasca. He also received research funding from Bristol Myers Squibb, Roche-Genentech, Pfizer, Sanofi. Travel support by Pfizer, Bio-Al Health, Replimmune. JP received travel support from Pierre Fabre, MSD, BMS, Novartis outside the scope of this study. JMR received speaker honoraria from Bristol-Myers Squibb, Roche, Amgen and Novartis and travel support by Sanofi, Roche, and Bristol-Myers Squibb through institution. MSC is a consultant advisor for Amgen, BMS, Eisai, Ideaya, MSD, Nektar, Novartis, Oncosec, Pierre-Fabre, Qbiotics, Regeneron, Roche, Merck and Sanofi, and received honoraria from BMS, MSD, Sanofi and Novartis. AH declares speakers and advisory board honoraria from Almirall, Bristol-Myers Squibb, Dermagnostix, Eisai, Highlight Therapeutics, Immunocore, Incyte, IO Biotech, KyowaKirin, MerckPfizer, Merck Sharp & Dohme, Neracare, Novartis, Philogen, Pierre Fabre, Regeneron, Replimune, Sanofi-Genzyme, Seagen, SunPharma, Xenthera; outside the submitted work. The remaining authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: Medication reviews in primary care provide an opportunity to review and discuss the safety and appropriateness of a person's medicines. However, there is limited evidence about access to and the impact of routine medication reviews for older adults in the general population, particularly in the UK. We aimed to quantify the proportion of people aged 65 years and over with a medication review recorded in 2019 and describe changes in the numbers and types of medicines prescribed following a review., Methods: We used anonymised primary care electronic health records from the UK's Clinical Practice Research Datalink (CPRD GOLD) to define a population of people aged 65 years or over in 2019. We counted people with a medication review record in 2019 and used Cox regression to estimate associations between demographic characteristics, diagnoses, and prescribed medicines and having a medication review. We used linear regression to compare the number of medicines prescribed as repeat prescriptions in the three months before and after a medication review. Specifically, we compared the 'prescription count' - the maximum number of different medicines with overlapping prescriptions people had in each period., Results: Of 591,726 people prescribed one or more medicines at baseline, 305,526 (51.6%) had a recorded medication review in 2019. Living in a care home (hazard ratio 1.51, 95% confidence interval 1.40-1.62), medication review in the previous year (1.83, 1.69-1.98), and baseline prescription count (e.g. 5-9 vs 1 medicine 1.41, 1.37-1.46) were strongly associated with having a medication review in 2019. Overall, the prescription count tended to increase after a review (mean change 0.13 medicines, 95% CI 0.12-0.14)., Conclusions: Although medication reviews were commonly recorded for people aged 65 years or over, there was little change overall in the numbers and types of medicines prescribed following a review. This study did not examine whether the prescriptions were appropriate or other metrics, such as dose or medicine changes within the same class. However, by examining the impact of medication reviews before the introduction of structured medication review requirements in England in 2020, it provides a useful benchmark which these new reviews can be compared with., (© 2023. The Author(s).)

Background: BRAF mutant melanoma treated with BRAF ± MEK inhibitor (targeted therapy) has a high response rate; however, most patients progress (PD). Some patients have durable response, but it is unknown whether treatment can be discontinued in these patients. We describe the recurrence risk, progression patterns, response to subsequent treatment, and survival of patients with advanced melanoma who ceased targeted therapy prior to PD., Patients and Methods: Ninety-four patients who ceased targeted therapy without progression were identified retrospectively from 11 centres: 45 were male; 81 V600E; 88 stage IV. Fifty-nine were treated with BRAF + MEK inhibitor, and 35 were treated with BRAF inhibitor alone. Median treatment duration was 29.6 months (range 0.36-77.9). At cessation, 67 were in complete response, 21 in partial response, and 2 stable disease., Results: After median follow-up from cessation of 42.9 months (range 0.0-88.7), 36 (38%) progressed; median time to progression was 4.7 months (range 0.7-56.9); 30 (83%) were asymptomatic and 7 (19%) had new brain metastases. Progression rates did not differ by best response: 34% for complete response and 43% for partial response (P = 0.65). Treatment duration was strongly associated with risk of progression: Median treatment duration was 18.3 (range 0.85-65.7) months for those who progressed and 34.6 (range 0.36-77.9) months for those who did not (P = 0.0004). Twenty-two received further targeted therapy with 15 (68%) responses., Conclusion: Risk of progression after cessation of targeted therapy is strongly associated with treatment duration. Response to retreatment with targeted therapy is high., Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: • PAA has/had a consultant/advisory role for Bristol Myers Squibb, Roche-Genentech, Merck Sharp & Dohme, Novartis, Merck Serono, Pierre-Fabre, AstraZeneca, Sun Pharma, Sanofi, Idera, Sandoz, Immunocore, 4SC, Italfarmaco, Nektar, Boehringer-Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Pfizer, Oncosec, Nouscom, Lunaphore, Seagen, iTeos, Medicenna, and Bio-Al Health. He also received research funding from Bristol Myers Squibb, Roche-Genentech, Pfizer, and Sanofi. • DBJ has served on advisory boards or as a consultant for BMS, Catalyst Biopharma, Iovance, Jansen, Mallinckrodt, Merck, Mosaic ImmunoEngineering, Novartis, Oncosec, Pfizer, and Targovax and has received research funding from BMS and Incyte. • DS has/had a consultant/advisory role in the last 3 years for Bristol Myers Squibb, Roche-Genentech, Merck Sharp & Dohme, Novartis, Merck Serono, Pierre-Fabre, Sun Pharma, Sanofi, Array, Sandoz, Immunocore, InFlarX, 4SC, Nektar, Neracare, Regeneron, Daiichi Sankyo, Pfizer, Philogen, Replimune, Oncosec, Innovent, Amgen and Haystack Oncology. His institution has also received research funding from Bristol Myers Squibb, Roche, MSD and Novartis. • EL served as consultant and/or has received honoraria from Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis, Medac, Sanofi, Sunpharma and travel support from Amgen, Merck Sharp & Dohme, Bristol-Myers Squibb, Pierre Fabre, Sunpharma and Novartis. • AMM: advisory board: Bristol-Myers Squibb, Merck Sharp and Dohme, Novartis, Roche, Pierre-Fabre, QBiotics. • GVL: advisor: Agenus, Amgen, Array Biopharma, Boehringer, Bristol-Myers Squibb, Evaxion, Hexal, Highlight Therapeutics S.L, Merck Sharp and Dohme, Novartis, Pierre Fabre, QBiotics, Regeneron. • MSC: consultant advisor: Amgen, Bristol-Myers Squibb, Eisai, Ideaya, Merck Sharp and Dohme, Nektar, Novartis, Oncosec, Pierre-Fabre, Qbiotics, Regeneron, Roche; honoraria: Bristol-Myers Squibb, Merck Sharp and Dohme, Novartis. • MM: Advisory Board/Consultant advisor: Takeda, Merck Sharp & Dohme, Roche, Guardant Health, Beigene, Pfizer, Merck Pte, Amgen, Novartis Pharma AG, The Limbic. • AH: Receives grants and person fees from Amgen, BMS, Eisai, Immunocore, Merck, Pfizer, MSD/Merck, Novartis Pharma, Philogen, Pierre Fabre, Regeneron, Repplimune, Roche, Sanofi-Genzyme, and Seagen outside of the submitted work. • AMM is supported by National Health and Medical Research Council (NHMRC) Investigator Grant, Nicholas and Helen Moore, and Melanoma Institute Australia. • LW: Advisory Board/Consultant advisor: Novartis and Bristol-Myers Squibb. • All other authors declare no COI., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

International literature suggests that gender-diverse people are at increased risk of thoughts and acts of self-injury compared to their cisgender peers. The current review aimed to investigate the prevalence of self-injurious thoughts and behaviours (SITBs) among children and young people (CYP) in the United Kingdom identifying as a gender not typically associated with the sex they were assigned at birth and, further, to examine relevant prevalence rates of SITBs reported both in academic and grey literature. In total, seven studies were included in the review and indicated an increased prevalence of SITBs among gender-diverse CYP compared to the general population. However, methodological limitations and significant heterogeneity in the rates of SITBs reported require that the available literature be interpreted with some caution. Important factors to consider when interpreting SITB rates, as well as recommendations for future research, are discussed.