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Background: Six randomized trials have not detected a difference between intravenous alteplase plus endovascular thrombectomy and endovascular thrombectomy alone in stroke. Tenecteplase, a recombinant human tenecteplase tissue-type plasminogen activator, is a genetically modified variant of alteplase. It is unclear whether the outcomes are different if alteplase is replaced with tenecteplase. This trial aims to determine whether intravenous tenecteplase within 4.5 hours of time last known well confers benefit in patients with acute ischemic stroke with large-vessel occlusion who undergo endovascular thrombectomy., Methods: BRIDGE-TNK (Thrombectomy With Versus Without rhTNK-tPA in Stroke) is an investigator-initiated, multicenter, prospective, randomized, open-label trial with blinded end point evaluation conducted at 40 thrombectomy-capable centers in China. This trial will randomize 544 patients with intravenous thrombolysis-eligible stroke (272 in each arm) with large-vessel occlusion within 4.5 hours of last known well to receive bridging intravenous tenecteplase with endovascular thrombectomy (tenecteplase-plus-thrombectomy group) or endovascular thrombectomy alone (thrombectomy-alone group). The primary outcome is the proportion of patients achieving functional independence, defined as a score of 0 to 2 on the modified Rankin Scale, at 90 days. Safety will be assessed via symptomatic intracranial hemorrhage at 48 hours and death at 90 days., Conclusions: BRIDGE-TNK will provide important data on the role of intravenous tenecteplase before endovascular thrombectomy in patients with acute ischemic stroke with large-vessel occlusion who can be treated within 4.5 hours of last known well., Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT04733742.

Background: Clinical practice guidelines (CPGs) are designed to assist health care professionals in medical decision-making, but they often lack effective integration of shared decision-making (SDM) principles to reflect patient values and preferences, particularly in the context of preference-sensitive CPG recommendations. To address this shortcoming and foster SDM through CPGs, the integration of patient decision aids (PDAs) into CPGs has been proposed as an important strategy. However, methods for systematically identifying and prioritizing CPG recommendations relevant to SDM and related decision support tools are currently lacking., Objective: The aim of the project is to develop (1) a tool for systematically identifying and prioritizing CPG recommendations for which SDM is considered particularly relevant and (2) a platform for PDAs to support practical SDM implementation., Methods: The project consists of 6 work packages (WPs). It is embedded in the German health care context but has an international focus. In WP 1, we will conduct a scoping review in bibliographic databases and gray literature sources to identify methods used to foster SDM via PDAs in the context of CPGs. In WP 2, we will conduct semistructured interviews with CPG experts to better understand the concepts of preference sensitivity and identify strategies for fostering SDM through CPGs. WP 3, a modified Delphi study including surveys and focus groups with SDM experts, aims to define and operationalize preference sensitivity. Based on the results of the Delphi study, we will develop a methodology for prioritizing key questions in CPGs. In WP 4, the tool will be developed. A list of relevant items to identify CPG recommendations for which SDM is most relevant will be created, tested, and iteratively refined, accompanied by the development of a user manual. In WP 5, a platform for creating and digitizing German-language PDAs will be developed to support the practical application of SDM during clinical encounters. WP 6 will conclude the project by testing the tool with newly developed and revised CPGs., Results: The Brandenburg Medical School Ethics Committee approved the project (165122023-ANF). An international multidisciplinary advisory board is involved to guide the tool development on CPGs and SDM. Patient partners are involved throughout the project, considering the essential role of the patient perspective in SDM. As of February 20, 2024, we are currently assessing literature references to determine eligibility for inclusion in the scoping review (WP 1). We expect the project to be completed by December 31, 2026., Conclusions: The tool will enable CPG developers to systematically incorporate aspects of SDM into CPG development, thereby providing guideline-based support for the patient-practitioner interaction. Together, the tool for CPGs and the platform for PDAs will create a systematic link between CPGs, SDM, and PDAs, which may facilitate SDM in clinical practice., International Registered Report Identifier (irrid): DERR1-10.2196/57611., (©Lena Fischer, Fülöp Scheibler, Corinna Schaefer, Torsten Karge, Thomas Langer, Leon Vincent Schewe, Ivan D Florez, Andrew Hutchinson, Sheyu Li, Marta Maes-Carballo, Zachary Munn, Lilisbeth Perestelo-Perez, Livia Puljak, Anne Stiggelbout, Dawid Pieper. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 04.11.2024.)

The evolution of radiation therapy techniques goes hand in hand with the evolution of the profession of radiation therapist. In the particular context of online adaptive radiotherapy based on cone beam computed tomography images, delegation of certain tasks from the physician to the radiation therapist is possible within the framework of a cooperation protocol. This delegation requires prior theoretical and practical training. It enriches the practice of radiation therapists by allowing them to acquire new skills and greater autonomy. It foreshadows access for radiation therapists to advanced practice., (Copyright © 2024 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.)

Background: Feeding intolerance is common in critically ill patients and can lead to malnutrition. Prokinetic agents may be used to enhance the uptake of nutrition. However, the evidence on the effectiveness and safety of prokinetic agents is sparse, and there is a lack of data on their use in intensive care units (ICU)., Methods: We will conduct an international 14-day inception cohort study of 1000 acutely admitted adult ICU patients. Data will be collected from ICU admission and daily during ICU stay for up to 90 days. The primary outcome will be the proportion of ICU patients who receive prokinetic agents. Secondary outcomes include mortality, days alive without life support, days alive out of ICU, days alive out of hospital (all within 90 days) and the number of patients with one or more serious adverse events., Results: We will present data on the use of prokinetic agents descriptively and use Cox regressions with death and ICU discharge as competing events to evaluate the association between patient characteristics and the use of prokinetic agents. We will use extended Cox models with time-varying covariates and linear regression models to assess the associations between the use of prokinetic agents and the secondary outcomes., Conclusion: The outlined international cohort study will provide valuable epidemiological data on the use of prokinetic agents in adult, acutely admitted ICU patients., (© 2024 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.)

The management of patients in shock or arrest is a critical aspect of emergency medicine and critical care. Rapid and accurate assessment is paramount in determining the underlying causes and initiating timely interventions. This article provides a summary of essential ultrasound protocols for the critically ill patient including the extended focused assessment with sonography for trauma (EFAST), rapid ultrasound for shock and hypotension (RUSH), and sonography in hypotension and cardiac arrest in the emergency department (SHoC-ED)., Competing Interests: Disclosure Dr J. Rosario has no financial disclosures. Dr J. Lin has no financial disclosures. Dr N. Saltarelli has no financial disclosures., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Diabetes distress (DD) is a prevalent concern among people with type 1 diabetes (T1D) and is linked to poor clinical outcomes. Instead of targeting the elimination of DD, we propose a novel approach that empowers individuals with strategies to manage their diabetes effectively in the context of DD: Acceptance and Commitment Therapy (ACT). The purpose of this in-progress trial is to compare an ACT group intervention (ACT1VATE) with usual care in improving HbA1c, DD, quality of life, and cost-effectiveness in adults with T1D., Methods: This is a two-arm, parallel group, randomized controlled superiority trial enrolling N = 250 adults with T1D, elevated HbA1c, and significant DD in a real-world community-based health system. Participants are randomized to receive ACT1VATE (a five-week ACT group telehealth intervention) or diabetes self-management education and support (usual care as the first-line recommended intervention for DD). The trial will examine comparative effectiveness in improving HbA1c, DD, quality of life, and cost-effectiveness over 12 months., Discussion: We predict that ACT1VATE will be superior given its (1) specific focus on DD, without any expectation that difficult diabetes-related thoughts and emotions must (or can) be completely eliminated; and (2) purposeful linkage of diabetes self-care behaviors to an individual's deeply held values, thus eliciting intrinsic, patient-centric motivation for meaningful and lasting health behavior changes. This trial will provide a valuable test of real-world effectiveness, drive sustainability and scalability, and inform the future of chronic disease care., Trial Registration: NCT04933851 (https://clinicaltrials.gov/ct2/show/NCT04933851)., Clinical Trial: Clinicaltrials.govNCT04933851https://clinicaltrials.gov/study/NCT04933851., Competing Interests: Declaration of competing interest The 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 Inc. All rights reserved.)

Background: Neonatal septic shock represents a critical and life-threatening condition that necessitates immediate and personalized interventions. Prior research endeavors have been undertaken to inform the optimization of neonatal septic shock management, yet substantial heterogeneity prevails in the selection, measurement, and reporting of outcomes across relevant studies. The heterogeneity in outcome selections and measures impedes the comparability of results and the synthesis of evidence, thus contributing to suboptimal utilization of research findings. This protocol presents the methodology for identifying and developing a Core Outcome Set for Neonatal Septic Shock Management (COS-NSS), intended for use in both research and routine clinical practice. A rigorous four-stage approach will be employed to develop the COS-NSS. In Stage 1, a scoping review will be conducted to compile a list of currently reported outcomes for neonatal septic shock management. Stage 2 will involve an expert stakeholder meeting using a semi-structured discussion approach to elucidate all identified outcomes and outcome domains, as well as to gather any additional outcomes. Moving to Stage 3, a two-round e-Delphi survey involving a wide variety of stakeholders will be undertaken to elicit diverse perspectives on the level of importance assigned to each proposed outcome. Finally, in Stage 4, the results of the Delphi study will be discussed in a consensus meeting to determine and agree on the final list of outcomes that will constitute the COS-NSS., Discussion: The stagewise approach integrates research evidence with multi-stakeholder perspectives to establish standardized outcomes that would improve consistency across neonatal septic shock trials. The development and uptake of the COS-NSS will facilitate effective comparison of studies, allowing for study synthesis and generation of high-quality evidence, thus ultimately fostering enhanced medical care for neonates suffering from septic shock., Trial Registration: Core Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: 2766 . Registered on July 19th, 2023., (© 2024. The Author(s).)

Background: The provision of speech intervention in children requires personalized, child-tailored approaches. Different speech-intervention approaches exist to eliminate cleft-related speech errors in children with a cleft palate. However, it is unclear what approach works best for the subtypes of cleft-related speech errors., Aims: To describe a protocol for a systematic review that provides speech-language pathologists with the current literature concerning more individualized speech intervention in children with a cleft palate., Methods & Procedures: A systematic literature review was performed following the preferred reporting items for systematic reviews and meta-analyses. Two speech-language pathologists with clinical and scientific experience in cleft speech searched different electronic databases for relevant studies. No limit regarding publication date was set. Specific eligibility criteria were defined and used to include or exclude the studies. All included studies were evaluated with a risk-of-bias assessment tool and levels of evidence. Relevant data were extracted from the studies (study design, study population characteristics, intervention characteristics and outcome characteristics) and a narrative synthesis was performed., Conclusions & Implications: The findings of this systematic review will significantly contribute to the evidence on personalized speech intervention in children with a cleft palate. The study will inform speech-language pathologists on the possibilities to tailor treatment plans more to the specific subtype of cleft-related speech errors. The planned systematic review also makes recommendations for further cleft speech intervention research., What This Paper Adds: What is already known on this subject At present, there is growing evidence for different speech therapy approaches in children with a cleft palate. Despite the recognized need for personalized, child-tailored therapy, there is no consensus on the best speech therapy approach per different subtype of compensatory cleft speech characteristic. What this study adds to the existing knowledge This paper provides a protocol for a systematic literature review of this topic. Specifically, it searches the literature for the use of personalized speech therapy approaches in children with different subtypes of compensatory cleft speech characteristics. What are the practical and clinical implications of this work? The systematic literature review provides speech-language pathologists with the current literature concerning personalized, performance-specific speech intervention in children with a cleft palate. Besides, the results will support therapy decision-making in children with a cleft palate in different speech-related clinical contexts., (© 2024 Royal College of Speech and Language Therapists.)

Objectives: Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) is one of the most common monogenic cerebral small vessel diseases. Our previous observational study suggested that lomerizine hydrochloride, a calcium channel blocker approved in Japan in 1999 for the prevention of migraine headaches, is also effective for preventing recurrent ischemic stroke in CADASIL patients. The aim of this study (LOMCAD trial) is to verify the efficacy of lomerizine hydrochloride., Materials and Methods: This is a multicenter, prospective, single-arm trial, using a historical control for comparison. CADASIL patients with a history of two or more cerebral ischemic events within the last two years will be administered lomerizine hydrochloride (5-mg tablet twice daily) for 24 months. The primary endpoint is symptomatic cerebral ischemic events during the 24-month period. Using our historical data and Bayesian sample size calculation based on a prior predictive distribution, the planned sample size was determined as 20 subjects., Conclusion: We have planned a clinical trial to verify the effectiveness of lomerizine hydrochloride as prophylaxis to prevent recurrent cerebral ischemic events in CADASIL patients., Registration: The LOMCAD trial has been registered in the Japan Registry of Clinical Trials (jRCTs051220072, https://jrct.niph.go.jp/latest-detail/jRCTs051220072)., Competing Interests: Declaration of competing interest The authors declare no potential conflicts of interest with respect to this study., (Copyright © 2024. Published by Elsevier Inc.)

Lung cancer is the leading cause of cancer related deaths worldwide, although some patients with early-stage disease can be cured with surgical resection. Standardised reporting of all clinically relevant pathological parameters is essential for best patient care and is also important for ongoing data collection and refinement of important pathological features that impact patient prognosis, staging and clinical care. Using the established International Collaboration on Cancer Reporting (ICCR) procedure, a representative international expert panel of nine lung pathologists as well as an oncologist was convened. Essential core elements and suggested non-core elements were identified for inclusion in the resected lung cancer pathology data set based on predetermined levels of evidence as well as consensus expert opinion. A lung cancer histopathology reporting guide was developed that includes relevant clinical, macroscopic, microscopic and ancillary testing. Critical review and discussion of current evidence was incorporated into the new data set including changes from the 2021 World Health Organisation (WHO) Classification of Thoracic Tumours, fifth edition, new requirements for grading invasive non-mucinous adenocarcinomas, assessment of response to neoadjuvant therapy and requirements for molecular testing in early-stage resected lung carcinomas. This ICCR data set represents incorporation of all relevant parameters for histology reporting of lung cancer resection specimens. Routine use of this data set is recommended for all pathology reporting of resected lung cancer and it is freely available worldwide on the ICCR website (https://www.iccr-cancer.org/datasets/published-datasets/). Widespread implementation will help to ensure consistent and comprehensive pathology reporting and data collection essential for lung cancer patient care, clinical trials and other research., (© 2024 John Wiley & Sons Ltd.)

We present a standardized metadata template for assays used in pharmaceutical drug discovery research, according to the FAIR principles. We also describe the use of an automated tool for annotating assays from a variety of sources, including PubChem, commercial assay providers, and the peer-reviewed literature, to this metadata template. Adoption of a standardized metadata template will allow drug discovery scientists to better understand and compare the increasing amounts of assay data becoming available, and will facilitate the use of artificial intelligence tools and other computational methods for analysis and prediction. Since bioassays drive advances in biomedical research, improvements in assay metadata can improve productivity in discovery of new therapeutics, platform technologies, and assay methods., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Vladimir A. Makarov reports financial support was provided by F Hoffmann-La Roche Ltd. Vladimir A. Makarov reports financial support was provided by Novartis Pharmaceuticals Corporation. Vladimir A. Makarov reports financial support was provided by GlaxoSmithKline Inc. Vladimir A. Makarov reports financial support was provided by Bristol Myers Squibb Co. Vladimir A. Makarov reports financial support was provided by AbbVie Inc. Vladimir A. Makarov reports financial support was provided by AstraZeneca Pharmaceuticals LP. Isabella Feierberg reports a relationship with Collaborative Drug Discovery Inc that includes: board membership. Isabella Feierberg reports a relationship with AstraZeneca Pharmaceuticals LP that includes: equity or stocks. Samantha Jeschonek reports a relationship with Revvity Inc that includes: equity or stocks. Vladimir A. Makarov reports a relationship with Elucidata Corporation that includes: consulting or advisory. Vladimir A. Makarov reports a relationship with Zifo RnD Solutions that includes: consulting or advisory. Vladimir A. Makarov reports a relationship with IBIS Inc. that includes: consulting or advisory. Vladimir A. Makarov reports a relationship with California State University Channel Islands that includes: employment. Ellen Berg reports a relationship with Phenovista that includes: board membership. Ellen Berg reports a relationship with Cashel Neural that includes: board membership. Ellen Berg reports a relationship with National Institutes of Health that includes: board membership. Ellen Berg reports a relationship with University of California San Francisco that includes: consulting or advisory. Vladimir A. Makarov reports a relationship with PIPA LLC that includes: consulting or advisory. Vladimir A. Makarov reports a relationship with Exelixis Inc that includes: consulting or advisory. Alex Clark has patent #US20160026622A1 issued to Collaborative Drug Discovery. Isabella Feierberg, co-author, previously employed by AstraZeneca; Ellen Berg, co-author, previously employed by Eurofins Panlabs; Sheryl Denker, co-author, previously employed by Eurofins Panlabs; Dana Vanderwall, co-author, previously employed by BMS; Samantha Jeschonek, co-author, previously employed by Collaborative Drug Discovery Inc. If there are other authors, they 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 The Authors. Published by Elsevier Inc. All rights reserved.)

Smoke-free legislation has been shown to positively impact reducing secondhand smoke (SHS) exposure, especially in countries that have implemented comprehensive legislation rather than partial bans. Also, secondhand aerosols (SHA) that come from the heating of tobacco or liquids, with or without nicotine, in electronic nicotine delivery systems (ENDS) have been proven to increase levels of harmful substances in the air. Therefore, protection against SHS and SHA exposure and expansion of smoke- and aerosol-free environments (SAFE) should be taken into account when creating or trying to expand or enforce clean air policies. This article aims to present the protocol for a consultation with experts on tobacco and nicotine control in order to identify best practices, barriers, and opportunities for the expansion of SAFE in Europe. We identified experts among policymakers, researchers, and tobacco regulators in European countries and invited them to participate in the consultation by completing an online survey designed, programmed, and pilot-tested using Survey Monkey. The responses to the questionnaire contained quantitative and qualitative information that was thematically analyzed. The experts' consultation allowed us to produce a report on barriers and opportunities for SAFE, a report and a position paper on SAFE best practices, a web-based repository of best practices, and a weight of evidence paper that assembles evidence supporting the expansion of SAFE on indoor and outdoor spaces., Competing Interests: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none was reported., (© 2024 Carnicer-Pont D. et al.)

Background: Rapid and flexible data collection efforts are necessary for effective monitoring and research on tobacco and nicotine product use in a constantly evolving marketplace. The Rutgers Omnibus Survey (1) provides timely data on awareness and use of new and emerging tobacco products among adults in a rapid manner, (2) provides a platform for measurement experiments to help develop and refine measures of tobacco use that reflect the current marketplace, and (3) generates pilot data for grant applications and scientific manuscripts., Objective: This study aims to document the first 2 years of the Rutgers Omnibus Study through the reporting of methodology, fielding summaries, and sample characteristics., Methods: Launched in February 2022 and fielded quarterly thereafter, we survey convenience samples of 2000 to 3000 US adults aged 18-45 years recruited from Amazon Mechanical Turk (MTurk) using the MTurk Toolkit by CloudResearch. The questionnaire includes core and rotating modules and is designed to take approximately 10 minutes to complete through Qualtrics. The fielding duration is approximately 10 days per wave. Each wave includes both unique and repeating participants, and responses can be linked across waves by an anonymous ID., Results: Sample sizes ranged from 2082 (wave 8, December 2023) to 2989 (wave 1, February 2022), and the 8-wave longitudinal dataset included 10,334 participants, of whom 2477 had 3 or more data points. The cost per complete at each wave was low, ranging from US $2.46 to US $3.27 across waves. Key demographics were consistent across waves and similar to that of the general population, while tobacco product trial and past-30-day use were generally higher., Conclusions: The Rutgers Omnibus Study is a quarterly survey that is effective for rapidly assessing the use of emerging tobacco and nicotine products and can also be leveraged to conduct survey experiments, generate pilot data, and address both cross-sectional and longitudinal research questions., International Registered Report Identifier (irrid): RR1-10.2196/58203., (©Michelle T Bover Manderski, William J Young, Ollie Ganz, Cristine D Delnevo. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.10.2024.)

Background: This study determined, implemented, and assessed a nurse-led radical cystectomy follow-up protocol., Methods: In 2021, an evidence-based risk-stratified protocol (non-urological cancers and benign [N-UC&B], low, or high risk) was developed from current guidelines, local and national expert opinion, and after formal discussion with the Urological Society of Australia and New Zealand (USANZ) Western Australia (WA) and Australia and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group. Retrospective and prospective assessment of cystectomy follow-up occurred between 2015 and 2023. Patients received 'surgeon-led' follow-up March 2015 to August 2021, and 'nurse-led' follow-up August 2021 to April 2023. Adherence to follow-up, cost-analysis, and healthcare efficiency calculations were performed., Results: Of 176 cystectomy patients, 159 (90.3%) were eligible for inclusion. Overall adherence to nurse-led follow-up was 78.6% compared to 43.4% in surgeon-led (P < 0.001). Adherence to nurse-led follow-up was higher in all risk categories (high-risk 79.1% vs. 43%, P < 0.001; low risk 75% vs. 52.3%, P = 0.110; N-UC&B 71% vs. 30%, P = 0.153). Nurse-led consultation saved $59.50 per consultation with overall cost savings of $179.50, $416.50, and $595 for the entire follow-up period for N-UC&B, low, and high-risk groups based on consultation alone. A total of 1072 appointments (536 h, $62 390.40) would have been saved if the surgeon-led cohort of patients were seen in nurse-led clinics., Conclusion: Protocol driven nurse-led cystectomy follow-up demonstrates excellent adherence and may be more cost-effective than surgeon-led follow-up., (© 2024 Royal Australasian College of Surgeons.)

Non-muscle-invasive bladder cancer (NMIBC) is a heterogeneous disease categorized as low, intermediate, high, or very high risk, for which recurrence and progression rates and thus management strategies differ. Current molecular subclassification of bladder cancer (BC) is mainly based on data for muscle-invasive disease, with very few data for NMIBC. A more accurate classification system is needed for better stratification of NMIBC using multiomics and immunohistopathological molecular data alongside clinical data collected in a prospective cohort. ProCaB (Prospective Sample Collection for Cancer of Bladder) is a single-center non-interventional, prospective study recruiting all eligible patients diagnosed with BC in a tertiary center in the Flanders region of Belgium. Clinical data have been collected in a prospective registry since August 2013. Biosamples (blood, urine, and BC tissue) are collected from each patient at diagnosis and are stored at -80°C at BioBank UZ Leuven after appropriate processing according to the protocol. Multiomics (genomics, epigenetics, transcriptomics, proteomics, lipidomics, metabolomics) and immunohistopathology analyses will be performed on appropriate samples. The target is to enroll 300 patients over a 5-yr period, and all patients will be followed for 5 yr. The objective is to create a biobank of samples from patients diagnosed with BC for use in multiomics and immunohistopathological analyses. Results from these analyses, together with long-term clinical data, can be used for comprehensive multilayered molecular characterization of disease recurrence and progression in intermediate- and (very) high-risk NMIBC, identification of multibiomarker panels for better stratification, and identification of a patient subgroup that does not respond to bacillus Calmette-Guérin treatment. This trial is registered on ClinicalTrials.gov as NCT04167332., (© 2024 The Author(s).)

Background: Self-harm in young people is a growing concern and reducing rates a global priority. Rates of self-harm documented in general practice have been increasing for young people in the UK in the last two decades, especially in 13-16-year-olds. General practitioners (GPs) can intervene early after self-harm but there are no effective treatments presently available. We developed the GP-led COPING intervention, in partnership with young people with lived experience and GPs, to be delivered to young people 16-25 years across two consultations. This study aims to examine the feasibility and acceptability of conducting a fully powered effectiveness trial of the COPING intervention in NHS general practice., Methods: This will be a mixed-methods external non-randomised before-after single arm feasibility study in NHS general practices in the West Midlands, England. Patients aged 16-25 years who have self-harmed in the last 12 months will be eligible to receive COPING. Feasibility outcomes will be recruitment rates, intervention delivery, retention rates, and completion of follow-up outcome measures. All participants will receive COPING with a target sample of 31 with final follow-up data collection at six months from baseline. Clinical data such as self-harm repetition will be collected. A nested qualitative study and national survey of GPs will explore COPING acceptability, deliverability, implementation, and likelihood of contamination., Discussion: Brief GP-led interventions for young people after self-harm are needed to address national guideline and policy recommendations. This study of the COPING intervention will assess whether a main trial is feasible., Registration: ISRCTN (ISRCTN16572400; 28.11.2023)., Competing Interests: Competing interests: FM and NK were members of the 2022 self-harm NICE clinical guideline development committee. No other competing interests were disclosed., (Copyright: © 2024 Mughal F et al.)

The standard way to measure the performance of existing continuous variable quantum key distribution (CVQKD) protocols is by using the achievable secret key rate (SKR) with respect to one parameter while keeping all other parameters constant. However, this atomistic method requires many individual parameter analyses while overlooking the co-dependence of other parameters. In this work, a numerical tool is developed for comparing different CVQKD protocols while taking into account the simultaneous effects of multiple CVQKD parameters on the capability of protocols to produce positive SKRs. Using the transmittance, excess noise, and modulation amplitude parameter space, regions of positive SKR are identified to compare three discrete modulated (DM) CVQKD protocols. The results show that the M -QAM protocol outperforms the M -APSK and M -PSK protocols and that there is a non-linear increase in the capability to produce positive SKRs as the number of coherent states used for a protocol increases. The tool developed is beneficial for choosing the optimum protocol in unstable channels, such as free space, where the transmittance and excess noise fluctuate, providing a more holistic assessment of a protocol's capability to produce positive SKRs.

Background: Stable angina pectoris (SAP), as a common type of coronary heart disease (CHD), is characterized by transient retrosternal squeezing pain or suffocation induced by exercise, mood swings, or other stress. Most patients with stable angina pectoris do not benefit from interventional therapy and medication, so optimizing treatment plans has important clinical significance. Jiuxin pill is a Chinese patent medicine developed by Huatuo Chinese Medicine Co. Ltd. (Bozhou, China) to relieve the symptoms of stable angina pectoris (SAP). However, there is a lack of evidence support from high-quality clinical studies., Methods: In this randomized, double-blind, placebo-controlled, multicenter clinical trial, 170 patients with SAP were recruited from 11 centers in China. The patients were randomized to either the treatment group (Jiuxin pill, 2 pills, bid) or the control group (Jiuxin pill simulant, 2 pills, bid) without changing the original conventional western medicine. The trial was set up with a run-in period of 7 days, a treatment period of 28 ± 2 days, and a follow-up period of 28 ± 2 days. Total exercise time (TED) in the treadmill test and Seattle Angina Questionnaire (SAQ) scores were set as the main efficacy outcomes, and the 1-minute heart rate recovery (HRR1), metabolic equivalents (METs), maximum ST segment depression, Borg perceived exertion after exercise, the average number of angina attacks per week, usage of nitroglycerin, drug withdrawal and reduction rate, information scoring of four diagnostic methods in traditional Chinese medicine and incidence of major adverse cardiovascular events were set as the secondary efficacy outcomes. Adverse events were monitored throughout the trial., Discussion: In China, the use of Chinese patent medicine in the treatment of stable angina pectoris is more common. This trial evaluated the efficacy and safety of the Jiuxin pill in the treatment of patients with SAP, and the trial results provide high-quality research evidence for its clinical application., Trial Registration: This trial has been registered in the China Clinical Trial Registry on 11 June 2022 (Registration No.: ChiCTR2200060780, https://www.chictr.org.cn/showproj.html?proj=172352)., Competing Interests: The authors confirm that they have no conflict of interest. None of the authors in this study received funding from the drug manufacturers involved. The drug manufacturer did not participate in any aspects of the study design, data collection, publication of the paper, etc. of this trial., (© 2024 Liu et al.)

Background: The aging population drives a growing demand for care, particularly in Europe. It is estimated that approximately 1.5-2 million individuals have a chronic wound. Among these, pressure ulcers (PUs) are one of the most prevalent complications in vulnerable individuals. Malnutrition is a primary risk factor, yet it can be mitigated through proper nutrition and adequate community support. The community nurse plays a crucial role in managing chronic conditions and nutrition through constant and professional monitoring., Aim: This article presents a comprehensive systematic review (SR) protocol to examine the role of community nursing of nutritional intervention of frail population with wound care., Methods: A SR will be conducted according to international standards and reported following the PRISMA Guidelines for SRs. The search will be conducted in PubMed/Medline, Scopus, Embase, and CINAHL, supplemented by grey literature sources. The methodological quality and risk of bias will be assessed using the Critical Appraisal Skills Programme (CASP) framework. The protocol has been registered in the Open Science Framework (OSF)., Conclusions: It is anticipated that the findings of this SR will provide new evidence on the relationships between nutritional nursing interventions and wound care management primarily in the community setting.

Objectives: This meta-analysis aims to compare the efficacy, limitations, and clinical implications of Abbreviated Breast MRI (AB-MRI) and Full Protocol MRI (FP-MRI). It focuses on diagnostic accuracy across various populations and settings, extending the scope of prior meta-analyses by including studies conducted after 2019 in both screening and diagnostic contexts., Methods: We conducted a systematic review (from 11/2019 to 12/2022). A bivariate model was used to calculate the summary estimates of sensitivity and specificity. Random effect models were used to calculate summary AUC and probability distributions for negative and positive predictive values were obtained. Subgroup analyses were conducted to investigate the differences between the AB-MRI and FP-MRI in terms of sensitivity, specificity, and AUC., Results: The search across multiple databases yielded 11 eligible studies, including one prospective and ten retrospective studies. Statistical analysis revealed a significant difference in sensitivity between FP-MRI (95%) and AB-MRI (86%, p = 0.005), but not in specificity (p = 0.50). AB-MRI demonstrated a shorter acquisition time, suggesting potential for increased patient throughput. However, challenges remain in detecting small lesions and non-mass enhancements, with some studies suggesting the inclusion of additional sequences such as DWI with ADC mapping to enhance diagnostic performance., Conclusion: While FP-MRI remains the gold standard in breast cancer detection, AB-MRI presents as a viable, quicker alternative, especially useful in high-risk screening scenarios. Its lower sensitivity compared to FP-MRI, however, limits its utility as a standalone diagnostic tool. Future research should focus on optimizing AB-MRI protocols and investigating patient-specific factors to refine breast cancer screening and diagnostic strategies., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Institute of Radiology.)

Background: Mental health issues are highly prevalent in older adults with mild cognitive impairment (MCI). Digital Health Interventions (DHIs) for individuals with MCI have proven effective in improving cognitive function, but their impact on mental health has received less attention., Objective: Reporting a protocol for a systematic review and meta-analysis to evaluate the effectiveness of DHIs for older adults with MCI, focusing on mental health outcomes both overall and within homogeneous subgroups., Methods: A systematic review and meta-analysis of randomized controlled trials will be conducted, with searches performed in the Cochrane Library, PubMed, Embase, Web of Science, CINAHL, CNKI, and WanFang date from inception to March 2024. Mental health outcomes are the primary outcome. Risk of bias will be assessed with the Cochrane Collaboration tool, and evidence quality will be evaluated with Grading of Recommendations Assessment, Development, and Evaluation. If sufficient studies are available, subgroup analysis will assess variations based on population and intervention characteristics, including types and modalities of DHIs, intervention settings, session frequency, and duration, focusing on specific mental health outcomes and both short- and long-term effects. Additionally, sensitivity analysis and meta-regression analysis will identify sources of other potential heterogeneity., Conclusion: The protocol will guide a systematic review and meta-analysis to determine the effectiveness of DHIs in improving mental health of older adults with MCI. This effort will enhance understanding and optimization of DHIs, vital for reducing mental health disparities and improving psychotherapy access for older adults with MCI., Prospero Registration Number: CRD42024522342., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2024.)

Globally, there has been an increasing call for dissemination and implementation science to improve the health equity of older adults. However, improving the health equity of older adults requires methods that allow for an in-depth understanding of the existing research. While the value of review articles is widely recognized, the value of publishing review protocols is an emerging paradigm with great potential to advance implementation science and aging research. In this article, we propose that prior to review articles, review protocols are necessary as they provide a clear and comprehensive search strategy, which greatly enhances the quality and rigor of reviews. More specifically, we argue that review protocols are indispensable because they support: (1) a clearly defined and comprehensive search methodology; (2) reviewer feedback to mitigate potential issues; and (3) registration to reduce risk of research replication. Additionally, we propose three strategies to accelerate review protocols in implementation science to support older adults' health equity., Competing Interests: The authors declare that the article was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Bacsu, Pottle, Fehr, Funk and Smith.)

Purpose: Peripheral arterial disease (PAD) is a chronic ischemic disease caused by atherosclerosis of the lower extremities, with early clinical symptoms manifesting mainly as intermittent claudication. Current treatment of PAD is based on the control of cardiovascular risk factors. However, even vasoactive drugs are not ideal for improving ischemic symptoms in the lower limbs of PAD patients. Ruanjian Qingmai granules, derived from the classic formula of the late Professor Jiuyi Xi, a famous traditional Chinese medicine doctor in Shanghai, have good clinical efficacy in the treatment of the pattern of blood vessel stasis and obstruction of PAD and have been used by more than 600,000 PAD patients over the past three decades. This study aims to evaluate the efficacy and safety of Ruanjian Qingmai granules in patients with symptomatic PAD., Patients and Methods: A prospective, center-randomized, double-blind, placebo-controlled clinical trial will be conducted at 9 grade A tertiary hospitals in Shanghai. It is anticipated that 250 patients with early symptomatic PAD will be recruited and randomized to the control and intervention groups (1:1 ratio of central randomization). Subjects will be treated with Ruanjian Qingmai granules or placebo at 6 g twice daily for 16 weeks. The primary efficacy indicators are the pain-free walking distance and maximum walking distance. The secondary efficacy indicators are the ankle-brachial index, walking impairment questionnaire, quality of life score, and Chinese medicine syndrome score., Conclusion: Positive results from this study will demonstrate the efficacy and safety of Ruanjian Qingmai granules in improving ischemic symptoms in patients with symptomatic PAD., Clinical Registration: This study has been registered with the Chinese Clinical Trials Registry (ChiCTR2200056109, Date: 02/01/2022, https://www.chictr.org.cn/showproj.html?proj=150982)., Competing Interests: The authors report no conflicts of interest in this work., (© 2024 Zhang et al.)

Background: Despite receiving adequate treatment, many tuberculosis (TB) survivors are left with post-tuberculosis complications, possibly due to lung tissue damage incurred during the active period of the disease. Current TB programs worldwide deliver quality care throughout the course of active TB treatment, yet often fail to provide organized follow-up once treatment ends. Post-tuberculosis lung disease (PTLD) is a prominent, yet underrecognized cause of chronic lung disease, managed similarly to chronic respiratory diseases with pharmacotherapy and/or personalized pulmonary rehabilitation interventions. Basic pulmonary rehabilitation packages for people finishing TB treatment are still lacking in low- and middle-income countries (LMICs). We offer a study protocol to evaluate the implementation of spirometry and symptom screening for PTLD among people who have completed TB treatment in a rural district in Mozambique., Methods: The overall objective of this study is to evaluate the introduction of a new screening program that utilizes symptom screening and spirometry for diagnosing PTLD among adolescents and adults that have completed TB treatment. This research protocol consists of three complementary components: 1) assessing the prevalence of PTLD among patients enrolled in the National TB Control Program (NTCP) at Carmelo Hospital (CHC) in Chókwè District, Mozambique; 2) evaluating anticipated implementation outcomes through the identification of the site-, provider-, and individual-level determinants that either facilitate or hinder the successful adoption, implementation, and maintenance of the spirometry screening program, and 3) evaluating the real-time implementation outcomes/processes in order to provide practical evidence-based key indicators of successful implementation of the spirometry screening program., Discussion: Providing well-organized, evidence-based care for individuals with a history of TB who are experiencing symptoms of PTLD can relieve chronic respiratory issues, enhance quality of life, and potentially lower the risk of further pulmonary infections, including recurrent TB. However, there is a significant gap in the literature regarding the implementation of best practices of HIV and TB health services delivery. Addressing this gap could assist Mozambique in improving diagnosis, treatment, and continuity of care for people formerly living with TB. The insights from this study will help decision-makers improve spirometry screening coverage, enhance intervention effectiveness, and translate our findings to evidence-based programming., Trial Registration: ISRCTN92021748 retrospectively registered., (© 2024. The Author(s).)

Purpose: Disk battery (DB) ingestion in children can lead to severe complications and mortality. This study details our experience in managing DB ingestion and its complications., Methods: We analyzed data from all patients treated for DB ingestion at our hospital from June 2010 to January 2024. A protocol established in 2010 requires angio-CT scans for esophageal DB cases and a multidisciplinary approach involving gastroenterologists, otolaryngologists, pediatric and airway surgeons, and cardiac surgeons., Results: We treated 22 patients. In June 2010, following the tragic death of a patient from an undiagnosed DB ingestion that led to an aortoesophageal fistula, our protocol was established. All DBs were removed endoscopically. Four patients needed additional surgery: two had tracheal resection/anastomosis and esophageal repair for large tracheoesophageal fistulas; one required aortic wall reinforcement with a patch; one underwent endoscopic removal with a sternal split to explore the aortic arch. All 22 patients survived and recovered clinically. One developed bilateral vocal cord palsy as a complication., Conclusion: Effective management of DB ingestion complications necessitates a collaborative, multidisciplinary approach. Our protocol has improved management strategies and patient outcomes., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet is a plant-based and anti-inflammatory diet that has the ability to protect and manage cardiovascular and nervous system diseases. Regarding that insomnia and cardiovascular problems are x`common in type 2 diabetes mellitus (T2DM), the present study will assess the effectiveness of the MIND dietary pattern on sleep quality, cardiometabolic indicators, and other psychological indicators., Methods: Forty-four overweight/obese T2DM women with insomnia, aged 30-65 years, will voluntarily participate in this randomized controlled trial and will be randomized to receive either a MIND low-calorie diet (MLCD) or a low-calorie diet (LCD) over a 3-month period. Before and after the study, sleep quality, some biochemical and cardiometabolic indices, cortisol, brain-derived neurotrophic factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), and oxidative stress indicators will be assessed., Discussion: The use of dietary interventions in the management of T2DM complications is practical and safe. This research seeks to investigate the capacity of the MIND diet in the management of insomnia and cardiovascular problems of DM. It is expected that the results of this research will provide new perspectives on using an ideal dietary regimen to treat these health conditions., Trial Registration: IRCT20181111041611N8. Registered on August 7, 2023. https://www.irct.ir/trial/71772., (© 2024. The Author(s).)

Introduction: Depression is a common non-motor symptom of Parkinson's disease (PD), which seriously affects the quality of life of patients with PD. The main clinical treatment method for depression in Parkinson's disease is medication treatment. However, the medication treatment has a long cycle and many adverse reactions. Acupuncture as a non-pharmacological intervention method, has been widely used in the treatment of patients with Parkinson's disease and depressive disorders in China. Therefore, the study of acupuncture in the treatment of early Parkinson's disease with mild to moderate depression has important practical significance., Methods and Analysis: In this randomized, single-blinded, and placebo-controlled study, a total of 88 patients with depression in Parkinson's disease (DPD) will be randomly allocated to either an acupuncture group or a control group in parallel in a 1:1 allocation ratio. Each group will receive 30 min acupuncture treatments or sham acupuncture treatments, 3 times a week, for 12 weeks, followed by a 36-week follow-up period. The primary outcome is the response rate of the Hamilton Depression Rating Scale-17 at 12 weeks. Data will be collected at baseline, at the end of the 12-week treatment period, and during the 12-week and 36-week follow-up., Discussion: This study hypothesized that acupuncture may treat DPD by restoring pathological alterations in brain neural activity. The findings will provide scientific evidence for acupuncture in the treatment of early PD with mild to moderate depression., Ethics and Dissemination: This clinical trial has been approved by the Medical Ethics Committee of the Beijing Hospital of Traditional Chinese Medicine (Approval No. 2023BL02-013-01). This trial has been registered with the Chinese Clinical Trials Registry (Registration No. ChiCTR2300069310). The results will be published in a peer-reviewed academic journal., Clinical Trial Registration: https://www.chictr.org.cn/, identifier ChiCTR2300069310., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Xiao, Ren, Yang, Wang, Li, Song, Yuan, Liu and Chen.)

Background: Chuna manual therapy (CMT), a Korean manual therapy technique predominantly used for treating low back pain (LBP) and related disorders, lacks well-conceived research focusing on its comparative effectiveness, safety, and economic evaluation, particularly with respect to complex CMT with established CMT diagnostic algorithms. This study aims to illustrate a protocol for a randomized clinical study for comparative effectiveness and cost-effectiveness of complex CMT with simple CMT and usual care., Methods: This is a protocol for a three-armed, multicenter, assessor-blinded, pragmatic, randomized controlled trial study. A total of 81 patients suffering from non-acute LBP with pelvic biomechanical lesions (PBL), characterized by a pain duration of at least two weeks and a Numeric Rating Scale (NRS) score of 5 or higher, will be recruited from two Korean medicine hospitals. These participants will be randomly assigned to one of three groups: complex CMT plus usual care (UC; n = 27), simple CMT plus UC (n = 27), or UC groups (n = 27). They will undergo treatment for 4 weeks, and follow-up assessments will be performed 8 weeks after treatment completion. The primary outcome will be the NRS score of LBP, and secondary outcomes will include the Oswestry Disability Index, Patient Global Impression of Change, credibility and expectancy questionnaire, three-dimensional posture analysis indicators, quality of life assessment, economic evaluation, and safety assessments., Discussion: This will be the first study to assess the comparative effectiveness, safety, and cost-effectiveness of complex CMT compared to UC and simple/complex CMT in patients with LBP and PBL. We will also analyze useful diagnostic methods to help in clinical practice for CMT diagnosis., Trial Registration: Clinical Research Information Service (CRIS), KCT0009210. Registered on February 28, 2024., (© 2024. The Author(s).)

Background: Policy implementation measurement lacks an equity focus, which limits understanding of how policies addressing health inequities, such as Universal School Meals (USM) can elicit intended outcomes. We report findings from an equity-focused measurement development study, which had two aims: (1) identify key constructs related to the equitable implementation of school health policies and (2) establish face and content validity of measures assessing key implementation determinants, processes, and outcomes. Methods : To address Aim 1, study participants (i.e., school health policy experts) completed a survey to rate the importance of constructs identified from implementation science and health equity by the research team. To accomplish Aim 2, the research team developed survey instruments to assess the key constructs identified from Aim 1 and conducted cognitive testing of these survey instruments among multiple user groups. The research team iteratively analyzed the data; feedback was categorized into "easy" or "moderate/difficult" to facilitate decision-making. Results : The Aim 1 survey had 122 responses from school health policy experts, including school staff ( n = 76), researchers ( n = 22), trainees ( n = 3), leaders of non-profit organizations ( n = 6), and others ( n = 15). For Aim 2, cognitive testing feedback from 23 participants was predominantly classified as "easy" revisions (69%) versus "moderate/difficult" revisions (31%). Primary feedback themes comprised (1) comprehension and wording, (2) perceived lack of control over implementation, and (3) unclear descriptions of equity in questions. Conclusions : Through adaptation and careful dissemination, these tools can be shared with implementation researchers and practitioners so they may equitably assess policy implementation in their respective settings.

Objectives: This study aimed to assess the feasibility and acceptability of using EMA questionnaires and physiological data via wristbands to measure day-to-day occupational stress, musculoskeletal pain, and mental health among university employees (N = 23), across 10 work days. Adherence to the study protocol as well as participant experiences (via semi-structured interviews) with the protocol were used to assess feasibility and acceptability of the method., Results: Adherence to the study protocol was excellent. Participants wore the wristband for a mean of 9.7 days. Participants completed a mean of 24.5 EMAs (out of 30). Semi-structured interviews with participants revealed that a small number of participants had difficulties uploading data from the wristband. The timing of EMAs was challenging for some participants, resulting in missed EMAs, raising questions about whether EMA frequency and timing could be changed to improve adherence. Some EMA items were difficult to answer due to the nature of participants' roles and the work undertaken. Overall, the protocol was feasible and acceptable but highlighted future potential changes including using a different physiological data collection tool, reducing the number of EMAs, adjusting EMA timings, and reviewing EMA items., (© 2024. The Author(s).)

Soil-transmitted helminth (STH) is a part of NTDs that remains to be eliminated because of its significant global impact. Diagnostics are essential in aiding the elimination of STH infection. Therefore, it is imperative to evaluate the progress of diagnostic techniques, especially molecular-based techniques. Nevertheless, there is currently no comprehensive systematic review and meta-analysis (SRMA) evaluating the performance of molecular-based techniques for diagnosing STH. This protocol, registered on PROSPERO (CRD42024563432), intends to assess the diagnostic accuracy of molecular-based techniques compared to microscopic-based techniques for four common STH infections ( A. lumbricoides, T. trichiura , hookworms, and S. stercoralis ) across global studies. Two authors will independently conduct the screening, study selection, data extraction, and quality assessment of this SRMA. The obtained studies will be assessed using QUADAS-2 and will be analyzed for publication bias and diagnostic accuracy, including sensitivity, specificity, NPV, PPV, and DOR, and SROC. This developed protocol is expected to be versatile enough to be implemented in the range of studies assessing the diagnostic accuracy of the advance compared to the convention methods with adjustments. The findings of this SRMA are expected to provide a valuable contribution towards achieving the goal of eradicating STH infection by 2030., Competing Interests: The 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., (© 2024 The Authors.)

To validate the Manipal Bedside Swallowing Screening Test (MBSST) for assessing aspiration in individuals with tracheostomy using Video Fluoroscopic Swallow Study (VFSS). A total of 53 tracheostomized participants were screened for aspiration at bedside and VFSS across different consistencies. Penetration Aspiration Scale (PAS) was used to substantiate the severity of aspiration if present. The test demonstrated both high sensitivity (91%; 95% confidence interval = 70.8-98.9) and diagnostic accuracy (96%; 95% confidence interval = 87.0-99.5) for detecting aspiration in individuals with tracheostomy. The Manipal Bedside Swallowing Screening Test is an easy to administer tool that has sufficient sensitivity to detect aspiration in individuals with tracheostomy. The MBSST will be an easy to administer tool and will help in screening for aspiration at bedside without any instrumental examination., Competing Interests: Competing interestsThe authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper., (© Association of Otolaryngologists of India 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.)

Introduction: Prospective randomized controlled trials (RCT) have a robust methodology, but some distortions may occur during the course of study. Some protocols may not be available at the time an article is reading. Some authors may change the methodology between the time the protocol was submitted and when the trial results are actually published. Others may distort results to favor more attractive findings and draw conclusions that support prior hypotheses. This has rarely been investigated and none explored the RCTs published in the Journal of Bone and Joint Surgery (JBJS). Therefore, we did a retrospective investigation aiming to determine: (1) the proportion of trials with a protocol deposited and accessible to the reader, (2) whether the trials scrupulously followed the filed protocols., Hypothesis: Protocols were available in over 80% of cases, and these protocols were followed in over 80% of trials for the primary endpoint., Patients and Methods: This was a retrospective study of articles published in the JBJS between January 2010 and November 2023. Differences in primary and secondary endpoints between protocols and articles were sought., Results: Of the 206 RCT articles studied, 113 (54.9%) described clear and identifiable endpoints, and 93 (45.1%) were not identifiable and were inferred in the results; 184 (89.3%) articles identified a trial protocol. For the 184 articles (89.3%) declaring a trial protocol in the text, 23 (11.1%) protocols were not accessible. In all, 45 articles (21.8%) thus had no protocol available on the Internet (i.e., not available to the reader either because it was not cited in the text or because it was not accessible) so we analyzed 161 articles. The primary endpoint remained unchanged in 97 articles (60.2%) out of the 161 studied, was changed in 64 articles (39.8%), and was lacking (protocol not accessible) in 45 articles (21.8% of all articles). The secondary endpoints of the articles were unchanged in 61 articles (37.9%) out of the 161 studied., Discussion: Like other leading journals, JBJS publishes RCT articles containing a significant proportion of inconsistencies between preoperative trial protocols and the methods actually used in the research., Level of Evidence: III; retrospective comparative study non randomized., (Copyright © 2024 Elsevier Masson SAS. All rights reserved.)

D-peptides, the mirror image of canonical L-peptides, offer numerous biological advantages that make them effective therapeutics. This article details how to use DexDesign, the newest OSPREY-based algorithm, for designing these D-peptides de novo . OSPREY physics-based models precisely mimic energy-equivariant reflection operations, enabling the generation of D-peptide scaffolds from L-peptide templates. Due to the scarcity of D-peptide:L-protein structural data, DexDesign calls a geometric hashing algorithm, Method of Accelerated Search for Tertiary Ensemble Representatives, as a subroutine to produce a synthetic structural dataset. DexDesign enables mixed-chirality designs with a new user interface and also reduces the conformation and sequence search space using three new design techniques: Minimum Flexible Set, Inverse Alanine Scanning, and K*-based Mutational Scanning.

Introduction: Many patients with atrial fibrillation have impaired renal function, and therefore pre-operative CT for radiofrequency catheter ablation should minimize the use of contrast media. This study describes a dual-region-of-interest (D-ROI) protocol for the scanning of pulmonary veins and left atrium (PVs-LA) with less contrast media and optimized scan timing compared to the single-region-of-interest (S-ROI) protocol, without compromising image quality., Methods: This study retrospectively included 100 patients who underwent PVs-LA CT between July 2019 and February 2022. The participants were divided into two groups: Those scanned using the S-ROI method (Group A, n = 50), and those scanned using the D-ROI method (Group B, n = 50). Descriptive statistical analysis of the contrast effect and scan timing was performed using quantitative and qualitative data collected from both groups of images., Results: The contrast media dose was larger in group A than in group B (63.6 ± 10.1 mL vs. 45.6 ± 6.9 mL; p < 0.001). The CT values of the PVs-LA did not differ significantly between groups A and B [434.2 ± 77.0 Hounsfield units (HU) and 428.8 ± 77.2 HU, respectively; p = 0.73]. Two evaluators determined appropriate scan timing (when PVs-LA reached a relatively sufficient contrast effect for diagnosis) in 23 (46%) and 45 (90%) patients from groups A and B, respectively (p < 0.001)., Conclusions: Although the radiation dose is slightly increased compared with the S-ROI method, the D-ROI method provides improved scan timing and images with similar contrast enhancement while reducing the amount of contrast medium administered., Implications for Practice: The novel D-ROI bolus tracking technique can reduce the contrast medium dose while optimizing scan timing., Competing Interests: Conflicts of interest statement We declare no conflicts of interest associated with this manuscript., (Copyright © 2024 The College of Radiographers. Published by Elsevier Ltd. All rights reserved.)

Background: Established protocols for implementing high-quality targeted temperature management (TTM) provide guidance concerning the cooling rate, duration of maintenance, and rewarming speed. However, whether compliant to TTM protocols results in improved survival and better neurological recovery has not been examined., Methods: A retrospective cohort study enrolled 1141 survivors of non-traumatic adult cardiac arrest with a pre-arrest cerebral performance category (CPC) score of 1-2 from 2015 to 2020 at a tertiary medical center. Of the survivors, 330 patients who underwent TTM were further included. Patients with spontaneous hypothermia (<35 °C) (n = 107) and expired during the TTM (n = 21) were excluded. A total of 202 patients were thus enrolled. One hundred and ten patients underwent TTM that completely complied with the protocol (protocol-complaint group), but 92 patients deviated in some manner from the protocol (protocol non-compliant group)., Results: Fifty patients (50%) and 46 patients (50%) in the protocol-compliant and non-compliant groups, respectively, did not survive to hospital discharge. In the protocol-compliant group, 42 patients (38.2%) had favorable neurological recovery, compared with 32 patients (34.8%) in the protocol non-compliant group. After adjusting for age, initial shockable rhythm, witnessed collapse, and cardiopulmonary resuscitation duration, protocol non-compliant was associated with the poor neurological outcomes (aOR 2.44, 95% CI = 1.13-5.25), but not with in-hospital mortality (aOR 1.31, 95% CI = 0.70-2.47). The most common reason for noncompliance was a prolonged duration reaching the target temperature (n = 33, 58.7%). The number of phases of non-compliant was not significantly associated with in-hospital mortality or poor neurological recovery., Conclusion: Among cardiac arrest survivors undergoing TTM, those who did not receive TTM that in compliance with the protocol were more likely to experience poor neurological recovery than those whose TTM fully complied with the protocols. The most frequently identified deviation was a prolonged duration to reaching the target temperature., Competing Interests: Declaration of competing interest The authors declare that they have no conflict of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Pressure injuries in intensive care patients are a safety issue. Specialized foam sacral prophylactic dressings prevent pressure injuries with several products available for clinicians to choose from., Objectives: Assess the feasibility of conducting a multisite trial to test the effectiveness of two dressings versus usual care in preventing sacral pressure injuries in intensive care patients., Methods: Using a three-arm pilot randomized trial design, adult intensive care unit patients at risk for pressure injuries were randomly allocated to the Mepilex® Sacrum dressing, the Allevyn™ Life Sacrum dressing or the control group. Daily pressure injury data were collected including a de-identified sacral photograph, which the blinded outcome assessor used to determine the study end point: a new sacral pressure injury. Pre-determined feasibility criteria were measured in terms of eligibility, recruitment, retention, intervention fidelity and missing data., Results: From May-September 2021, we screened 602 intensive care unit adult patients for eligibility with 93 % (n = 558) excluded. Forty-four (7 %) were eligible, and all were recruited and randomized (100 %). After receipt of the intervention two participants withdrew from the study. Our final sample of 42 participants were randomly allocated to the Mepilex® (n = 12), Allevyn™ (n = 14) or control (n = 16) group. The interventions were delivered as intended and there were 11 (6 %) cases of missing outcome data. Five participants (12 %) developed a sacral pressure injury, four of whom received a sacral dressing., Conclusions: A larger trial is feasible with minor refinement to the length of stay eligibility criterion., Implications for Practice: Prophylactic sacral dressings are recommended for pressure injury prevention. Determining the feasibility of a larger trial to test the effectiveness of two dressings versus usual care in preventing sacral pressure injuries in intensive care patients can provide evidence to aid clinicians, policy makers and managers make value-based care decisions., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Professor Fiona Coyer holds an educational consultancy with Molnlycke Pty Ltd., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Introduction: Advances in endoscopic endonasal transsphenoidal surgery have led to improved postoperative outcomes after pituitary adenoma resection, including reduced length of stay, complications and readmission rates, without compromising safety and satisfaction., Methods: Our team implemented a perioperative protocol in January 2021 for patients undergoing endoscopic, transsphenoidal pituitary surgery. This study compares preoperative characteristics and postoperative outcomes in 279 patients between 2016 and 2022 (128 preprotocol and 151 postprotocol). Our protocol includes interdisciplinary preoperative evaluations, unified communication, cortisol thresholds for postoperative glucocorticoid replacement, and fluid restriction to prevent delayed hyponatremia., Results: Median age was 54 ± 17 years with 50.8% female patients. There were 229 (82.1%) macroadenomas (>1 cm) and 50 (17.9%) microadenomas/cysts (<1 cm). Mean diameter was 18 (transverse), 18 (craniocaudal), 16 (anteroposterior) mm. Tumor types included 125 (44.8%) gonadotroph, 46 (16.4%) adrenocorticotroph, 40 (14.3%) lactotroph, 26 (9.3%) Rathke cysts, 19 (6.8%) somatotroph, 13 (4.6%) nondiagnostic, 3 (1%) somatotroph-lactotroph, 3 (1%) mammosomatotroph, 2 (0.71%) null cell, and 2 (0.7%) thyrotroph adenomas. Postprotocol, 74.2% of patients were discharged on postoperative day 1 compared with 46.1% preprotocol (P < 0.0001). Transient arginine vasopressin deficiency decreased from 10.4% (preprotocol) to 4.6% postprotocol (P = 0.101). Hyponatremia occurred in 13.3% pre-protocol and 4.6% postprotocol. Emergency department visits dropped from 9.4% to 3.9%, and readmissions decreased from 7.8% to 2.6%. Persistent arginine vasopressin deficiency affected 2.3% preprotocol and 1.3% postprotocol patients. Cerebrospinal fluid leaks occurred in 8.5% preprotocol and 7.3% postprotocol., Conclusions: Implementing an interdisciplinary, perioperative protocol for transsphenoidal endoscopic pituitary surgery improves length of stay while minimizing readmissions and surgery-related complications., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Currently, no reporting guidelines exist for observational and qualitative study protocols. In an effort to enhance the quality of research protocols, we introduce two study protocol reporting checklists that we have developed., Main Recommendations: These checklists include educational components and examples intended to assist novice researchers. Through the analysis of 333 study protocols submitted for ethical review, our checklists have been developed and validated, demonstrating their applicability across various observational and qualitative study designs., Changes in Management: We provide insights into the systematic implementation of these checklists alongside complementary elements that support their effectiveness. We recommend longitudinal monitoring and evaluation of checklist utilization., Competing Interests: Declaration of Competing Interest The 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.)

Traumatic brain injury (TBIs) necessitates a rapid and comprehensive medical response to minimize secondary brain injury and reduce mortality. Emergency medical services (EMS) clinicians serve a critical role in the management of prehospital TBI, responding during an initial phase of care with significant impact on patient outcomes. We used versions two and three of the Brain Trauma Foundation (BTF) Prehospital Guidelines for the Management of Traumatic Brain Injury and the NASEMSO National Model Clinical Guidelines to determine key elements for a TBI prehospital protocol and included common factors across sources such as recommendations concerning patient monitoring, hypoxia, hypotension, hyperventilation, cerebral herniation, airway management, hyperosmolar therapy, and transport destination. We then conducted a cross-sectional evaluation of publicly available statewide EMS clinical protocols in the US to determine the degree of alignment with national guidelines. We calculated descriptive statistics for each factor in the state protocols. Despite adoption of some evidence-based recommendations for a standard approach to the prehospital management of patients with TBI, we found significant variability in statewide EMS treatment protocols for management of severe TBI, especially in the recommended frequency of patient reassessment and for the management of suspected herniation. Most statewide protocols provided guidance regarding oxygenation, ventilation, and blood pressure management that aligned with evidence-based guidelines. While most protocols did address management of oxygenation and ventilation, one in four protocols had no specific guidance for managing hypoxia and only 31% of protocols recommended avoiding hyperventilation. For the management of suspected cerebral herniation, over half of statewide protocols recommended hyperventilation, whereas only 31% explicitly advised against hyperventilation regardless of TBI severity. Interestingly, 94% of protocols do not mention the use of hyperosmolar therapy for TBI patients, neither recommending use or avoidance of hyperosmolar therapy. In conclusion, we found inconsistent adoption of national recommendations in available statewide protocols for prehospital TBI management. We identified significant gaps and variation in statewide protocols regarding patient monitoring and reassessment, as well as in several key areas of severe TBI management., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Young adults with cancer diagnosed between the ages of 18 to 39 are recognized as a vulnerable group with unique emotional, social, and practical needs that put them at risk of poor psychosocial outcomes and impaired health-related quality of life (HRQOL). This study describes the protocol of a randomized controlled trial to evaluate the efficacy of Bright IDEAS-Young Adults (Bright IDEAS-YA), a problem-solving skills training intervention, on psychosocial outcomes of young adults newly diagnosed with cancer., Methods: Bright IDEAS-YA is a two-arm, parallel, randomized controlled trial. Young adults are eligible if they are 18-39 years of age, within four months of a first cancer diagnosis, and receiving systemic therapy with life expectancy of at least six months. Participants are randomized 1:1 to Bright IDEAS-YA or enhanced usual care. Survey measures are completed at enrollment and 3, 6, 12, and 24 months. The primary endpoint will be the estimated change from baseline to 6 months in symptoms of depression, anxiety, and psychosocial HRQOL. The other time points are secondary endpoints. Mediators and moderators will be examined., Conclusions: This randomized trial will determine the efficacy of Bright IDEAS-YA on psychosocial outcomes for young adults newly diagnosed with cancer. Analyses will also examine mechanisms of action and potentially identify subgroups for whom the intervention is particularly useful., Trial Registration: clinicaltrials.gov #NCT04585269., Competing Interests: Declaration of competing interest The 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 The Authors. Published by Elsevier Inc. All rights reserved.)

Postoperative care is essential to upper extremity replantation success and includes careful and frequent monitoring of the replanted part. During this period, pharmacologic agents such as antithrombotic and anticoagulants may prevent complications such as arterial thrombosis and venous congestion. Dressings and therapy can also impact short- and long-term outcomes following replantation. This article reviews the literature to provide guidance for postoperative protocols following upper extremity replantation., (© 2023. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)

Tobacco addiction is the primary preventable factor contributing to global mortality, and nicotine is one of the substances with the greatest potential for addiction. With a strong affinity for the α4β2 subtype receptor, cytisine (CYT) functions as a partial agonist of the acetylcholine nicotinic cholinergic receptor. It counteracts the effects of nicotine without causing any withdrawal symptoms. These features, combined with its limited mild adverse effects and minimal drug-drug interactions, make cytisine a cost-effective treatment for smoking cessation. The current protocol describes a prospective observational study on the safety and efficacy of CYT administered to inpatient smokers of the Integrated University Hospital of Verona (IUHVR), Veneto (Italy). This is a monocentric, observational, and prospective study on both sex smokers over the age of 18 years admitted to the IUHVR who meet the criteria for recruitment and have given their consent. Eligible participants will be assigned to the CYT intervention based on the West dosing schedule and will be followed up for 12 months from treatment initiation. Evaluation of safety, efficacy, and compliance will be assessed at 7 and 25 days, with follow-up at 3, 6, and 12 months from the start of the treatment (quit day). During each visit, any adverse events or adverse reactions reported by patients following the intake of CYT will be evaluated. This study will contribute, for the first time, to the knowledge about the use of CYT for smoking cessation in a hospital setting., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Torazzi, Tedesco, Ceccato, Santin, Campagnari, Losso, Toldo, Casari, Arzenton, Marini, Chiamulera and Lugoboni.)

Background: Nurses face high levels of stress and emotional exhaustion due to heavy workloads and demanding work environments. Prolonged exposure to these stressors predisposes nurses to burnout, which can adversely affect patient care. Addressing burnout among nurses requires a multifaceted approach, involving both personal and organizational strategies. While organizational strategies target systemic workplace issues, personal interventions are often favored for their ease of implementation, immediate benefits, and empowerment of health care workers through stress management and resilience-building. Prioritizing evidence-based interventions to mitigate burnout among nurses is crucial for managing occupational stress and promoting well-being. Person-directed psychoeducation is an effective personal intervention strategy used to equip nurses with the appropriate knowledge and skills to handle stressors, thereby safeguarding their mental health and ensuring high-quality patient care., Objective: This protocol proposes a systematic review that aims to identify and assess the effectiveness of person-directed psychoeducational interventions for nurses. The review aims to pinpoint effective interventions that can be implemented to manage burnout and support the mental health of nurses., Methods: This systematic review will follow the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. In total of 5 electronic databases (PubMed-MEDLINE, EBSCOhost, Ovid MEDLINE, Scopus, and ScienceDirect) will be searched for studies published between January 1, 2014, and December 31, 2023. The search will encompass 3 main keywords: "nurses," "burnout intervention," and "burnout." Predefined eligibility criteria will guide the screening process. Data will be extracted to address the objectives of the review. The risk of bias for each study will be assessed using Joanna Briggs Institute Critical Appraisal Tools., Results: Preliminary searches have been initiated since February 2024, with the review expected to be completed by June 2024. The expected results will include a comprehensive list of psychoeducational interventions and their effectiveness in reducing burnout among nurses. The review will highlight interventions that demonstrate significant impact in published studies from various countries., Conclusions: Given the rising prevalence of burnout among nurses and its detrimental effects on individuals and health care organizations, the findings from this systematic review are expected to inform health care policy and practice. By evaluating different interventions, it will provide insights into the most effective strategies, contributing to evidence-based practices that support nurses' mental health and well-being. The findings can support stakeholders in developing and implementing targeted strategies to combat nurse burnout, ultimately enhancing the quality of patient care and health care delivery. In addition, the findings will also offer valuable information for researchers, guiding future practice and research in this area., Trial Registration: PROSPERO CRD42024505762; https://tinyurl.com/4p84dk3d., International Registered Report Identifier (irrid): DERR1-10.2196/58692., (©Ili Abdullah Sharin, Norehan Jinah, Pangie Bakit, Izzuan Khirman Adnan, Nor Haniza Zakaria, Shazwani Mohmad, Siti Zubaidah Ahmad Subki, Nursyahda Zakaria, Kun Yun Lee. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.09.2024.)

The HEALthy Brain and Child Development (HBCD) study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The study plans enrolling over 7000 families across 27 sites. This manuscript presents the measures from the Neurocognition and Language Workgroup. Constructs were selected for their importance in normative development, evidence for altered trajectories associated with environmental influences, and predictive validity for child outcomes. Evaluation of measures considered psychometric properties, brevity, and developmental and cultural appropriateness. Both performance measures and caregiver report were used wherever possible. A balance of norm-referenced global measures of development (e.g., Bayley Scales of Infant Development-4) and more specific laboratory measures (e.g., deferred imitation) are included in the HBCD study battery. Domains of assessment include sensory processing, visual-spatial reasoning, expressive and receptive language, executive function, memory, numeracy, adaptive behavior, and neuromotor. Strategies for staff training and quality control procedures, as well as anticipated measures to be added as the cohort ages, are reviewed. The HBCD study presents a unique opportunity to examine early brain and neurodevelopment in young children through a lens that accounts for prenatal exposures, health and socio-economic disparities., Competing Interests: Declaration of Competing Interest The 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 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Improving the quality of midwifery education to international standards is critical to prepare competent midwives. Despite the recognised impact of competent midwives, little is known concerning the implementation of Competency-Based Education (CBE), especially in Africa, where poor investment in quality midwifery education has been reported., Objective: The aim of this study is to scope and synthesize the existing literature on the implementation of CBE for midwifery programmes and its sustainability in Africa., Methods: The scoping review methodology outlined by Arksey and O'Malley framework was adopted to explore the extent of the literature on the implementation of CBE for midwifery programmes and its sustainability in Africa. This framework directed the scoping review methodology, with reference to PRISMA-ScR guidelines., Results: A total sample of 72 studies were finally included in this scoping review. Reporting of the scoping review findings follows the PRISMA- ScR format. The study showed that of the 54 African countries as per the World Bank classification, after review of the full articles following the eligibility criteria for inclusion, literature on midwifery education programmes only spanned 17 African countries as at the time of this report. Of which, 11 are implementing CBE, 5 are still using Traditionally Based Approaches (TBA) while Problem-Based Learning (PBL) is the main teaching pedagogy used in Botswana. This review revealed that for the successful implementation of CBE, a CBE curriculum implementation process must be strictly observed. Evidence from the literature confirmed that CBE has not been sustained in Africa. There is still a struggle to fully integrate the major components of the competency-based midwifery programme due to inadequate support and an inadequate monitoring system., Conclusions: It is expedient that CBE implementation should be planned concurrently with its sustainability for it to be effective. Adequate training and support should be continuously provided to faculties, institutions, policy makers, professional bodies, students and other stakeholders for successful implementation and sustainability., International Registered Report Identifier (irrid): PRR1- https://doi.org/10.2196/47603 ., (© 2024. The Author(s).)

Background: Enhancing social participation is not only the main goal of stroke survivors' community rehabilitation but also a protective factor affecting their physical and emotional health. The current state of stroke survivors' social participation is not encouraging due to the high disability incidence of stroke. Spouses may play a facilitating role in the social participation of patients by providing them with support and assistance. However, there remains a lack of evidence specifically regarding dyadic coping interventions of social participation for stroke survivors, and the intervention strategies are still underdeveloped without clear theoretical frameworks. Therefore, this proposed study aims to develop and evaluate the effectiveness of the Dyadic Coping Intervention of Social Participation (DCISP) for survivors of first-episode homebound stroke., Methods: A single-blind (assessor-blinded), randomized controlled trial will be conducted to verify the effectiveness of DCISP. The randomized controlled trial will be preceded by a feasibility study (N = 20) of DCISP in stroke survivors. Stroke survivors will be randomly classified (1:1) into either a control (N = 50) or an experimental group (N = 50). In addition to routine care, participants in the experimental group will receive six 40 ~ 45 min sessions of guidance, once every two weeks. The primary outcome is social participation of stroke survivors, measured using Impact on Participation and Autonomy Questionnaire (IPA) and Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P), and the secondary outcomes will be measured by Knowledge Questionnaire for Stroke Patients (SPKQ), Stroke-specific Quality of Life Scale (SS-QOL), Dyadic Coping Inventory (DCI), Modified Rankin Scale (mRS) and Zarit Caregiver Burden Interview (ZBI-22). These will be measured at baseline(T0), during the intervention (T1 = 1 month), and after intervention completion (T2 = 3 months, T3 = 6 months)., Discussion: Findings from the study will provide evidence of the effects of DCISP on improving the social participation of first-episode homebound stroke survivors. The results of this study may support the implementation of survivor-spouse dyads care support in stroke survivors and provide a reference for clinical rehabilitation nursing practice, offering new insights into nursing interventions for stroke patients., Trial Registration: Chinese Clinical Trial Registry (ChiCTR) ChiCTR2400083072. Registered on 20 July 2023., (© 2024. The Author(s).)

Background: Suicide is a major public health problem, especially among individuals over 50 years old. Despite the suitability of this life stage for prevention, research on the efficacy of psychological interventions is scarce and methodologically limited, affecting their clinical utility and efficacy. Brief, flexible interventions that can be applied both in-person and remotely are needed. This study aims to evaluate the efficacy of a brief problem-solving-based suicide prevention program applied through various modalities to individuals over 50 years old., Methods: A randomized controlled trial will be conducted. A sample of 212 adults aged 50 or older with suicidal ideation will be randomly assigned to a problem-solving-based psychological intervention administered face-to-face (PSPI-P; n = 53), by telephone multiconference (PSPI-M; n = 53), via a smartphone app (PSPI-A; n = 53), or to a usual care control group (UCCG; n = 53). The intervention will be delivered in 7 sessions or modules of 90 min each. Blind trained evaluators will conduct assessments at pre-intervention, post-intervention, and follow-ups at 3, 6, and 12 months. The primary outcome will be suicidal ideation evaluated using the Suicidal Ideation Scale (SSI) and the Columbia Suicide Severity Rating Scale (C-SSRS). Secondary outcomes will include hopelessness, anxiety and depression symptoms, reasons for living, impulsivity, problem-solving skills, social support, anger syndrome, gratitude, personality, dropouts, treatment adherence, and satisfaction with the intervention., Discussion: This study will provide evidence of the efficacy of a brief problem-solving-based intervention for suicide prevention in individuals over 50 years old, administered face-to-face, by telephone multiconference, and via a smartphone app. If results are favorable, it will indicate that an effective, accessible, clinically and socially useful suicide prevention intervention has been developed for affected individuals, families, and communities., Trial Registration: ClinicalTrials.gov NCT06338904. Registered April 1, 2024., (© 2024. The Author(s).)

Background: Music therapy is the clinical use of musical interventions to improve mental and physical health across multiple domains, including social communication. Autistic children, who have difficulties in social communication and often increased anxiety, tend to show a strong preference for music, because it can be structured and systematic, and therefore more predictable than social interaction. This makes music therapy a promising medium for therapeutic support and intervention. Previous clinical trials of music therapy compared to traditional therapy for autistic children have shown encouraging but nevertheless mixed results., Key Aims: The primary aim is to conduct a randomised controlled trial (RCT) of improvisational music therapy for autistic children and test its effectiveness in at improving social communication and wellbeing, and to reduce anxiety., Research Plan: The RCT will be conducted with 200 autistic children in the UK aged 7 to 11 years old. Participants will be randomly assigned to either improvisational music therapy or support as usual. The trial will be an assessor-blind, pragmatic two-arm cluster RCT comparing the impact of 12-weeks of improvisational music therapy in addition to support as usual, vs. support as usual for autistic children., Methods: Researchers who are blind to which arm the children are in will conduct assessments and obtain data via caregiver reports. The primary outcome will be the absolute change in the total score of the Brief Observation of Social Communication Change (BOSCC) assessed at baseline, T1 (13 weeks) and T2 (39 weeks) follow-ups. The BOSCC consists of specific items that were developed to identify changes in social-communication behaviours. Secondary outcome measures include: (1) Parent reported anxiety scale for youth with ASD (Note that we do not use the term 'ASD' or Autism Spectrum Disorder, because many autistic people feel it is stigmatising. Instead, we use the term 'autism') (PRAS-ASD) (2) Young Child Outcome Rating Scale, for wellbeing (YCORS), (3) Strengths and Difficulties Questionnaire (SDQ); and (4) Vineland Adaptive Behaviour Scale (VABS). (5) The Children's Communication Checklist-2 (CCC-2) will be completed to evaluate pragmatic speech with fluent speakers only; (6) The Music Engagement Scale (MES); and (7) Assessment of the Quality of Relationship (AQR) will be used to evaluate the child-therapist relationships using video-analysis of music therapy sessions. Additional data will be collected by administering the Wechsler Abbreviated Scale of Intelligence (WASI-II), Music at Home Questionnaire (M@H), and children's versions of the Empathy Quotient (EQ) and Systemizing Quotient (SQ). Audio and video data from the therapy sessions will be collected and analysed (using both human and computer-based feature-coding, e.g., machine learning and AI-driven methods) to identify how music and non-musical interactions foster change throughout the therapy., Discussion: This study aims to observe if the interactions, engagement, and therapeutic modalities fostered during music therapy sessions can translate to non-musical contexts and improve autistic children's social communication skills, identifying possible mediating factors contributing to the effectiveness of music therapy, potentially informing policy making and governance., Trial Registration: This randomised control trial is registered with the NIH U.S. National Library of Medicine:  https://clinicaltrials.gov/search?term=NCT06016621 , clinicalTrials.gov Identifier: NCT0601662, Registration Date 19th August 2023., (© 2024. The Author(s).)

Background: [ 18 F]MK-6240 is a neurofibrillary tangles PET radiotracer that has been broadly used in aging and Alzheimer's disease (AD) studies. Majority of [ 18 F]MK-6240 PET studies use dynamic acquisitions longer than 60 min to assess the tracer kinetic parameters. As of today, no consensus has been established on the optimum dynamic PET scan time. In this study, we assess the reproducibility of [ 18 F]MK-6240 quantitative metrics using shortest dynamic PET protocols in cognitively normal subjects. PET metrics were measured through two-tissue compartment model (2TCM) and Logan model to estimate VT and DVR, as well as SUVR from 90 to 120 min (SUVR 90 - 120 min ) post-tracer injection for brain regions. 2TCM was carried out using the 120 min dynamic coffee break dataset (first scan from 0 to 60 min p.i., second scan from 90 to 120 min p.i.) and then repeated after stepwise shortening it by 5 min. The dynamic scan length that reproduced the 120 min dynamic scans-based VT to within 10% error was defined as the shortest acquisition time (SAT). The SAT SUVR 90 - 120 min was deduced from the SAT dataset by extrapolation of each image pixel time-activity curve to 120 min. The reproducibility of the 120 min dynamic scans-based VT 2TCM , DVR 2TCM , DVR Logan , and SUVR using the SAT was assessed using Passing-Bablock analysis. The limits of reproducibility of each PET metrics were determined using Bland-Altman analysis., Results: A dynamic SAT of 40 min yielded < 10% error in [ 18 F]MK-6240 VT 2TCM 's for all brain regions, compared to those measured using the 120 min datasets. SAT-based analysis did not show statistically significant systemic or proportional biases in VT 2TCM , DVR 2TCM , DVR Logan , or SUVR compared to those deduced from the full dynamic dataset of 120 min. A mean difference between the 120 min- and SAT-based analysis of less than 4%, 10%, 15%, and 20% existed in the VT 2TCM , DVR 2TCM , DVR Logan , and SUVR respectively., Conclusion: Kinetic modeling of [ 18 F]MK-6240 PET can be accurately performed using dynamic scan times as short as 40 min. This can facilitate studies with [ 18 F]MK-6240 PET and improve patients accrual. Further work would be necessary to confirm the reproducibility of these results for patients in dementia spectra., (© 2024. The Author(s).)