Background: The global push to scale up telemedicine services is challenged by complex, multilevel, multifaceted implementation and a lack of consensus on what the evidence-based essential building blocks of implementation are. Objective: We aimed to evaluate the evidence base supporting telemedicine implementation knowledge tools; identify shared conceptual constructs and outliers; and formulate recommendations to guide the design, development, and optimization of telemedicine services. Methods: We conducted implementation research using a rapid umbrella review, that is, an overview of systematic reviews, in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). In total, we searched 3 databases (PubMed, Web of Science, and Scopus) for studies focusing on telemedicine implementation frameworks, models, and tools, collectively referred to as "knowledge tools." Reviews meeting the operational definition of a systematically undertaken, secondary evidence synthesis, such as systematic and scoping reviews, and those published from January 2018 to May 2024 were considered. A meta-aggregative qualitative analysis was undertaken, comprising inductive thematic synthesis. Results: In total, 18 reviews were selected, encompassing 973 primary studies. Global perspectives were reflected in 61% (n=11) of the reviews, while 33% (n=6) focused on low- and middle-income country contexts. The primary research included in the reviews represented 63 countries, spanning the Americas, Europe, Africa, the Middle East, and Asia and the Pacific. Findings indicated substantial heterogeneity across the identified telemedicine implementation theories, models, and frameworks. However, following evidence synthesis, considerable convergence was observed, highlighting a state-of-the-art understanding of the essential requirements for a national telemedicine implementation ecosystem. These were categorized into "process" and "thematic" dimensions. Process dimensions included readiness and needs assessment, road map and planning, managing change, implementing telemedicine services, and continuous improvement and measuring performance. Thematic dimensions covered human and sociocultural aspects; organization, operations, management, and leadership; communication and coordination; policy, legal, and financial considerations; clinical health condition and quality of care; and the wider context. Conclusions: The findings of this study inform a pressing translational research knowledge gap in telemedicine implementation, hindering the implementation of high-quality, sustainable, and scalable telemedicine systems. The study contributes to building global consensus on the state of the art of key constructs in telemedicine implementation and recommends that future research focus on field-testing the evidence-based implementation tools to evaluate their usability and adaptability across diverse telemedicine contexts.

Background: Telehealth technologies can enhance patients' and their families' access to high-quality resources in home-based palliative care. Nurses are deeply involved in delivering telehealth in home-based palliative care. However, no previous integrative systematic reviews have synthesized evidence on nurses' roles, facilitators, and barriers to implementing nurse-delivered telehealth in home-based palliative care. Objective: This integrative systematic review aimed to provide a comprehensive understanding of the roles of nurses and the multilevel facilitators and barriers to implementing nurse-delivered telehealth in home-based palliative care, which could inform future policy development, research, and clinical practice. Methods: This integrative systematic review was conducted using Joanna Briggs Institute methodological guidance. We followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines. We systematically searched articles published from January 1, 2014, to May 2024 in PubMed, Embase, Web of Science, CINAHL, and Cochrane Library. We included English-language; peer-reviewed; original; and qualitative, quantitative, and mixed methods studies that centered on nurse-delivered telehealth in home-based palliative care. We used the Mixed Methods Appraisal Tool to assess the quality of the included articles. Furthermore, 3 authors independently assessed eligibility, extracted data, and assessed the quality of articles. The entities to extract were identified by research questions of interest regardless of the type of study. We applied a convergent synthesis approach to integrate quantitative and qualitative data. Guided by the updated Consolidated Framework for Implementation Research (CFIR) 2.0, we synthesized the facilitators and barriers to implementing nurse-delivered telehealth in home-based palliative care. Results: This integrative systematic review identified 4819 unique articles, including 34 papers encompassing 29 unique primary research studies. Innovations were mainly delivered by nurses (n=8) and nurse-involved multiprofessional teams (n=18). The roles of nurses in telehealth home-based palliative care involve palliative care nurses, community nurses, nurse coordinators, nurse coaches or nurse navigators, and nurse case managers. Guided by CFIR 2.0, facilitators and barriers to implementing nurse-delivered, telehealth, home-based palliative care were identified to 6 implementation levels and 20 constructs. The key facilitators included the COVID-19 pandemic, cost avoidance to the health care system, engagement of patients and their family caregivers, and so on. The barriers included a lack of reimbursement and payment mechanisms, technical problems, insufficiently trained health care providers, and so on. Conclusions: This integrative systematic review synthesizes evidence on nurses' evolving roles in telehealth home-based palliative care and identifies multilevel facilitators and barriers to nurse-delivered, home-based palliative care implementation. With the empowerment of telehealth technologies, nurses could establish a stronger professional identity and develop leadership in home-based palliative care. Nurses should leverage influence to promote nursing practice, clinical management, and policy support in the implementation of telehealth home-based palliative care. Trial registration: PROSPERO CRD42024541038; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024541038.

Background: Electrophysiology (EP) procedures, including cardiac implantable electronic devices (CIEDs) and ablations, are widely used to manage arrhythmias and heart failure. These interventions, though effective, require substantial resources, prompting the need for systematic economic evaluations to inform healthcare decision-making. Methods: A systematic review of studies from 2007 to 2024 was conducted in two phases. Phase one assessed trends in economic evaluations of EP procedures, analyzing 129 studies across regions and timeframes. Phase two focused on cost-effectiveness analyses of implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy defibrillators (CRT-Ds), and atrial fibrillation (AF) ablation, examining outcomes like quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs), while identifying factors influencing economic results. Results: EP procedures generally demonstrated favorable cost-effectiveness, particularly in high-income regions. Studies on ICDs and CRT-Ds consistently supported their economic value for patients with arrhythmias or heart failure, while AF ablation showed potential for long-term benefits, particularly when compared to medical therapies. However, results varied by region, reflecting differences in healthcare systems, costs, and patient populations. Conclusions: The review highlights the overall cost-effectiveness of EP procedures in many settings but underscores the need for tailored economic evaluations in low- and middle-income countries. Simplified methodologies and greater attention to regional contexts are recommended to guide resource allocation and policy development globally.

Background: White light (conventional) colonoscopy (WLC) is widely used for colorectal cancer screening, diagnosis and surveillance but endoscopists may fail to detect adenomas. Our goal was to assess and synthesize overall and subgroup-specific adenoma miss rates (AMR) of WLC in daily practice. Methods: We conducted a systematic review in MEDLINE, EMBASE, Cochrane Library, and grey literature on studies evaluating diagnostic WLC accuracy in tandem studies with novel-colonoscopic technologies (NCT) in subjects undergoing screening, diagnostic or surveillance colonoscopy. Information on study design, AMR overall and specific for adenoma size, histology, location, morphology and further outcomes were extracted and reported in standardized evidence tables. Study quality was assessed using the QUADAS-2 tool. Random-effects meta-analyses and meta-regression were performed to estimate pooled estimates for AMR with 95% confidence intervals (95% CI) and to explain heterogeneity. Results: Out of 5,963 identified studies, we included sixteen studies with 4,101 individuals in our meta-analysis. One in three adenomas (34%; 95% CI: 30-38%) was missed by WLC in daily practice individuals. Subgroup analyses showed significant AMR differences by size (36%, adenomas 1-5 mm; 27%, adenomas 6-9 mm; 12%, adenomas ≥ 10 mm), histology (non-advanced: 42%, advanced: 21%), morphology (flat: 50%, polypoid: 27%), but not by location (distal: 36%, proximal: 36%). Conclusions: Based on our meta-analysis, one in three adenomas could be missed by WLC. This may significantly contribute to interval cancers. Our results should be considered in health technology assessment when interpreting sensitivity of fecal occult blood or other screening tests derived from studies using WLC as "gold standard".

Background: Population-wide newborn blood spot screening programmes are a successful public health intervention used to detect whether the baby is at risk of certain rare conditions, with the aim of earlier diagnosis and provision of optimal care and treatment. Evaluating candidate conditions to include in newborn blood spot and genetic sequencing raises questions regarding acceptability to parents/carers. Methods: In the context of the possible expansion of the newborn blood spot screening programme in the United Kingdom, this review aimed to systematically review research on the acceptability to parents of newborn blood spot screening and genetic sequencing. A protocol was developed prior to commencing the review and was registered on the PROSPERO database. A team of researchers carried out the review, with checking at all stages carried out by at least two individuals. We included research published after 2013 with participants who were pregnant or a recent parent of a newborn and were resident in a high-income country. We included quantitative and qualitative studies that investigated the acceptability to parents/carers of newborn blood spot screening or genetic sequencing. Quantitative studies were narratively synthesised, and theories/frameworks identified and evaluated. Qualitative studies were analysed for recurring themes, and a meta-synthesis was carried out to compare and contrast these two types of data. We quality appraised included articles using tools appropriate for their study design. Results: Searches were carried out in September to November 2023 and screening identified 25 relevant research articles. Just over half were from North America, with four existing reviews and nine qualitative studies. Domains of acceptability described in the literature were: support for screening; level of anxiety, information and knowledge; consent; views of the procedure; and support after screening. The research indicated consensus support for blood spot screening, and for expanding to some other conditions, although some parental anxiety was reported. Parents/carers mostly perceived that they had received sufficient information, but the timing of this could be improved. While parents indicated interest in genomic screening, studies highlighted the need for clearer consent procedures and greater support for parents following genomic screening than for blood spot screening. Only three included studies reported using any kind of theoretical framework. Discussion: Most parents/carers found newborn blood spot screening programmes to be acceptable and favoured their large-scale implementation. A minority of parents/carers expressed concerns regarding the acceptability of processes underpinning newborn blood spot screening, such as consent, the timing of receiving information and support available after testing. More research is needed regarding the acceptability of newborn genomic sequencing screening programmes, which are less established compared with newborn blood spot screening programmes. Limitations: The over-representation of studies conducted in the United States has implications for the applicability of findings to other countries where testing is not typically mandatory and health systems differ considerably. Most studies were of cross-sectional design and there was limited representation of people from lower incomes and non-white ethnicity. While the inclusion of studies only in populations of future or very recent parents provided coherence to the findings, unclear reporting of participants may have resulted in under- or overinclusion of some studies. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR159927.

目的 采用健康测量工具选择的共识标准(COSMIN)对高血压健康促进行为的评估工具进行系统评价。方法 计算机检索Embase、Web of Science、PubMed、Cochrane Library、中国生物医学文献服务系统、中国知网、万方数据知识服务平台中关于高血压健康促进行为评估工具的开发、信效度检验的文献，检索时限为建库至2024-05-25。由两名研究生独立进行文献筛选与资料提取。采用COSMIN偏倚风险评价清单评价纳入评估工具的方法学质量，根据COSMIN质量准则评价纳入评估工具的测量学属性质量。应用改良版定量系统评价证据分级(GRADE)方法评价证据等级，根据测量学属性质量评价结果及证据等级确定评估工具的推荐级别。结果 最终纳入文献14篇，共涉及14个高血压健康促进行为评估工具，其中运动行为改变评定量表(MCPAQ)、高血压患者限盐饮食行为改变评定量表(MCRSDH)、运动决策平衡修订量表(DBS)、中文版高血压自我护理量表(HBPSCP)、高血压自我护理量表(HTN-SCP)、健康促进生活方式量表-Ⅱ(HPLP-Ⅱ)中文版为高血压健康促进行为评估工具在不同国家的跨文化...

The Arctic region, characterised by its remote and geographically challenging environment, is home to predominantly Indigenous populations who experience significant healthcare disparities compared to urban counterparts. This paper synthesises evidence on the persistent challenges in delivering healthcare in the Arctic, including geographical remoteness, healthcare personnel shortages, and cultural and language barriers. Telehealth emerges as a crucial solution, offering a nuanced approach to overcoming physical and systemic barriers. We review current implementations of telehealth in the Arctic, highlighting successful adaptations to local cultural contexts and technological limitations. By integrating a patient-centred approach, infrastructure readiness, and relevant telehealth services, a holistic healthcare delivery model tailored for the Arctic environment is proposed. New type of technologies is also proposed to enhance remote care possibilities. This paper underscores the need for collaborative efforts in research, policy making, and healthcare provision to ensure the sustainability and effectiveness of health services in the Arctic, aiming to close the gap in health equity. Key references from seminal works and recent studies provide a foundation for the discussions and recommendations presented.

目的:总结维持性血液透析病人人工血管内瘘(AVG)自我管理的相关证据。方法:系统检索国内外相关指南库、肾内科相关专业网站及国内外相关医学数据库中有关维持性血液透析病人AVG相关文献，文献类型包括指南、专家共识、临床决策、证据总结、系统评价等，检索时限从建库至2023年11月30日。由循证团队进行文献纳入、质量评价、证据提取及推荐强度进行汇总。结果:本研究共纳入文献15篇，其中指南8篇，专家共识1篇，临床决策3篇，系统评价2篇，证据总结1篇。从健康教育、AVG的监测与体格检查、日常维护、并发症识别和质量持续改进5个方面形成27条推荐意见。结论:总结维持性血液透析病人AVG自我管理相关证据，可为临床病人对AVG自我管理提供参考，从而提高AVG远期通畅率。

目的 对Gibbs反思循环模型在护理教学中应用的研究进行范围审查，探讨国内外Gibbs反思循环模型在护理教学中的应用现状、教学策略及其教学效果。方法 计算机检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、Web of Science、Cochrane library、Embase数据库，检索时限为建库至2023年11月30日，应用Arksey和O'Malley提出的报告框架对纳入文献进行范围综述。结果 共纳入19篇文献，其中10篇英文文献，9篇中文文献，发表时间为2017-2023年，Gibbs反思循环模型已广泛应用于护理专业教学中，但目前国内师资培训尚不规范，部分教学实施步骤欠严谨，教学评价科学性不足。结论 Gibbs反思循环模型应用有利于提升护理教学质量，对增强学生及护士的专业水平及综合能力具有重要意义，但应规范师资培训过程，明确实施步骤和各阶段教学重点，建立双向、多维度教学评价机制。

Introduction: Diversifying voice therapy strategies is critical to get children and adolescents to adhere to the therapeutic process. Purpose: To investigate the face-to-face and distance playful strategies have been used for vocal health education and voice therapy in children and adolescents. Methods: An integrative literature review was carried out based on the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes (PRISMA). A search for full texts was conducted on the Virtual Health Library, Scientific Electronic Library Online (SCIELO) and PuBMed databases using the following descriptors, and their corresponding Medical Subject Headings (MeSH): voice (voz); voice quality (qualidade da voz); dysphonia (disfonia); voice disorders (distúrbios da fala); voice training (treinamento da voz); telemedicine (telemedicina); therapeutics (terapêutica); health promotion (promoção da saúde); group practice (prática de grupo); recreation therapy (terapia recreacional); child (criança); preschool (pré-escolar) and adolescent (adolescente). Results: After full reading of the studies, 15 articles were included and categorized into the following topics: face-to-face and distance playful strategies for voice therapy in children; playful strategies with gamification for education and for voice therapy in children; and vocal health educational actions in children. Conclusion: The study found a higher number of studies that carried out educational actions and playful strategies, while fewer studies were related to the production of materials, gamification and online services for voice therapy in children. Given the proven benefits of this strategy for children, further studies focusing on the development and application of playful strategies, such as the use of gamification, should be conducted in order to stimulate the skills and adherence of this population to therapy.

Telemedicine use has been increasing especially during the COVID-19 pandemic. Various studies have outlined benefits of telemedicine including improving health equity, reducing wait times, and cost-effectiveness. Skin diseases such as atopic dermatitis (AD) may potentially be managed via telemedicine. However, there are no evidence-based recommendations for best practices in telemedicine for assessing AD patients. The objective of this review is to assess and summarize current evidence on telemedicine modalities for AD. This review will assess patient outcomes from various telemedicine models for AD. A review protocol was developed according to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. Two reviewers independently screened potential studies and extracted data. Studies were included if they evaluated any telemedicine assessment for AD. Of 2719 identified records, 5 reports were included. Two reports used the direct-access online model, 1 used web-based consultation, 1 used e-health through a personal eczema portal, and 1 used an online platform and mobile application. All models were variations of the asynchronous, store and forward model. In all the included reports, teledermatology for the follow-up of patients with AD was effective and equivalent when compared to in-person appointments or standard treatment for their respective key outcome measures. However, it is unclear what the most effective teledermatology model is due to significant heterogeneity between studies. Teledermatology may serve as an important tool for triaging and follow-up of patients with AD. More studies are needed to determine which teledermatology models are most effective for virtual assessment of AD.

Aim: This meta-analysis aimed to compare the efficacy of in-person and digital mental health interventions in addressing Postpartum Depression. Methods: Following PRISMA guidelines, the protocol for this meta-analysis was registered at the Open Science Framework (Retrieved from osf.io/wy3s4). This meta analysis included Randomized Controlled Trials (RCTs) conducted between 2013 and 2023. A comprehensive literature search identified 35 eligible RCTs from various electronic databases. Inclusion criteria focused on pregnant women over 18 years old, encompassing antenatal depression and up to two years postpartum. Diagnostic interviews or Edinburgh Postnatal Depression Scale (EPDS) were used to establish PPD. Digital interventions included telephonic, app-based, or internet-based approaches, while in-person interventions involved face-to-face sessions. Results: The meta-analysis revealed a moderate overall effect size of -0.69, indicating that psychological interventions are effective for PPD. Digital interventions (g = -0.86) exhibited a higher mean effect size than in-person interventions (g = -0.55). Both types of interventions displayed substantial heterogeneity (digital: I2 = 99%, in-person: I2 = 92%), suggesting variability in intervention content, delivery methods, and participant characteristics. Conclusion: Digital mental health interventions show promise in addressing PPD symptoms, with a potentially greater effect size compared to in-person interventions. However, the high heterogeneity observed in both modalities underscores the need for further research to identify key drivers of success and tailor interventions to diverse populations. Additionally, the choice between digital and in-person interventions should consider individual needs and preferences. Ongoing research should further investigate and optimise intervention modalities to better serve pregnant women at risk of PPD.

Introduction: Periodontitis is the main cause of tooth loss and is related to many systemic diseases. Artificial intelligence (AI) in periodontics has the potential to improve the accuracy of risk assessment and provide personalized treatment planning for patients with periodontitis. This systematic review aims to examine the actual evidence on the accuracy of various AI models in predicting periodontitis. Methods: Using a mix of MeSH keywords and free text words pooled by Boolean operators ('AND', 'OR'), a search strategy without a time frame setting was conducted on the following databases: Web of Science, ProQuest, PubMed, Scopus, and IEEE Explore. The QUADAS-2 risk of bias assessment was then performed. Results: From a total of 961 identified records screened, 8 articles were included for qualitative analysis: 4 studies showed an overall low risk of bias, 2 studies an unclear risk, and the remaining 2 studies a high risk. The most employed algorithms for periodontitis prediction were artificial neural networks, followed by support vector machines, decision trees, logistic regression, and random forest. The models showed good predictive performance for periodontitis according to different evaluation metrics, but the presented methods were heterogeneous. Conclusions: AI algorithms may improve in the future the accuracy and reliability of periodontitis prediction. However, to date, most of the studies had a retrospective design and did not consider the most modern deep learning networks. Although the available evidence is limited by a lack of standardized data collection and protocols, the potential benefits of using AI in periodontics are significant and warrant further research and development in this area. Knowledge transfer statement: The use of AI in periodontics can lead to more accurate diagnosis and treatment planning, as well as improved patient education and engagement. Despite the current challenges and limitations of the available evidence, particularly the lack of standardized data collection and analysis protocols, the potential benefits of using AI in periodontics are significant and warrant further research and development in this area.

Objectives: There is increasing recognition of the value and capabilities of design in healthcare. Beyond the development of medical devices, design is increasingly being applied to intangible, complex and systemic healthcare problems. However, there is limited evidence on the use of design specifically in the field of oral health. This systematic mapping study aims to collate and catalogue evidence of design in oral health. Methods: A systematic search of academic databases and grey literature was performed. Duplicate results were removed, and publications relating to the same project were grouped. Reviewers from design and oral health independently screened a sample of the dataset. Projects of both relevance to oral health, and with input from a designer or clear implementation of a design methodology or approach were included. Projects were coded and plotted on a novel interactive evidence map. Results: 119 design and oral health projects were included between 1973 and 2022. Interventional (n = 94, 79%), empirical (n = 46, 39%), methodological (n = 35, 29%) and theoretical (n = 7, 6%) design contributions were identified across the projects. The projects were categorized by four orders of design: first-graphics (n = 6, 5%), second-products (n = 41, 34%), third-interactions (n = 70, 59%), and fourth-systems (n = 2, 2%). Design was found in a diverse range of contexts in oral health; most commonly being relevant to general patients (n = 61, 51%), and for use in general dental practice (n = 56, 47%). Further design outcome categories (digital material; printed material; object; room or space; apparel; process; smart device; tangible interface; graphical interface; virtual reality; service; policy; system) and oral health themes (oral health literacy; oral care training; dental clinic design; dental instruments and equipment; personal oral care; dental appliance; clinician health and productivity; clinical information systems; informed consent; oral health promotion and prevention; oral care training; patient interactions and experience) were identified. Conclusions: The novel interactive evidence map of design in oral health created enables ongoing and open-ended multivariant documentation and analysis of the evidence, as well as identification of strategic opportunities. Future research and policy implications include; recognition and engagement with the full capabilities of design; integration of design experts; fostering inclusive engagement and collaboration; disentangling patient and public involvement; advancing human-centred systems approaches; adopting design-led approaches for policy-making.

BACKGROUND: Very few studies have investigated telepharmacy (TP) in critical care. This scoping review undertook this task. METHODS: We searched the following five electronic databases (PubMed, Embase, WoS, Scopus, CINAHL). Data were extracted from the articles and mapped out. Arksey and O'Malley's 6-step framework was used, and data synthesis identified activities, benefits, economic impact, challenges, and knowledge gaps of TP in critical care. RESULTS: Out of 77 reports retrieved, 14 were included in the review as per inclusion criteria. Eight studies (57%) were published since 2020, and 9 (64%) were from the United States. Tele-ICU was in place before TP implementation in six studies (43%). TP used a range of synchronous/asynchronous communications. Studies reported wide assortment of reactive/scheduled TP activities. Patient outcomes were evaluated in one study of sedation-related TP interventions but they were not different despite improved compliance with sedation protocol. Most common clinical interventions/drugs included glycemic, electrolyte, and antimicrobial therapy management and antithrombotic agents among others. Acceptance of TP interventions was 75% or more in four studies and 51-55% in two studies. Benefits of TP included resolved drug-related problems, increased compliance with guidelines, maintained interactions with other health care providers, and patient safety among others. Three studies (21%) reported cost avoidance with TP interventions. Challenges included communication, intervention documentation, tracking implementation of recommendations, and monetary/financial and legislative/regulatory issues. Knowledge gaps comprised lack of frameworks for implementation/evaluation of TP in critical care, methodological aspects, lack of patient-specific outcomes, as well as institution/health-system aspects, and documentation systems, cost, legislative, and sustainability issues. CONCLUSIONS: TP in critical care is underpublished, and comprehensive frameworks for its implementation and evaluation remain lacking. Assessments are needed to evaluate the effect of TP in critical care on patient-specific outcomes, its economic and legal dimensions, methods to sustain it, as well as the role of documentation systems, collaboration models, and institutional characteristics.

Authors' recommendations: Current evidence could not establish the benefit, harm, or cost-effectiveness of intrathecal drug delivery systems compared with current standards of care for managing refractory cancer pain in adults. Publicly funding intrathecal drug delivery systems for cancer pain would result in a budget impact of several hundred thousand dollars per year.

Background: Hybrid closed-loop systems are a new class of technology to manage type 1 diabetes mellitus. The system includes a combination of real-time continuous glucose monitoring from a continuous glucose monitoring device and a control algorithm to direct insulin delivery through an insulin pump. Evidence suggests that such technologies have the potential to improve the lives of people with type 1 diabetes mellitus and their families. Aim: The aim of this appraisal was to assess the clinical effectiveness and cost-effectiveness of hybrid closed-loop systems for managing glucose in people who have type 1 diabetes mellitus and are having difficulty managing their condition despite prior use of at least one of the following technologies: continuous subcutaneous insulin infusion, real-time continuous glucose monitoring or flash glucose monitoring (intermittently scanned continuous glucose monitoring). Methods: A systematic review of clinical effectiveness and cost-effectiveness evidence following predefined inclusion criteria informed by the aim of this review. An independent economic assessment using iQVIA CDM to model cost-effectiveness. Results: The clinical evidence identified 12 randomised controlled trials that compared hybrid closed loop with continuous subcutaneous insulin infusion + continuous glucose monitoring. Hybrid closed-loop arm of randomised controlled trials achieved improvement in glycated haemoglobin per cent [hybrid closed loop decreased glycated haemoglobin per cent by 0.28 (95% confidence interval -0.34 to -0.21), increased per cent of time in range (between 3.9 and 10.0 mmol/l) with a MD of 8.6 (95% confidence interval 7.03 to 10.22), and significantly decreased time in range (per cent above 10.0 mmol/l) with a MD of -7.2 (95% confidence interval -8.89 to -5.51), but did not significantly affect per cent of time below range (< 3.9 mmol/l)]. Comparator arms showed improvements, but these were smaller than in the hybrid closed-loop arm. Outcomes were superior in the hybrid closed-loop arm compared with the comparator arm. The cost-effectiveness search identified six studies that were included in the systematic review. Studies reported subjective cost-effectiveness that was influenced by the willingness-to-pay thresholds. Economic evaluation showed that the published model validation papers suggest that an earlier version of the iQVIA CDM tended to overestimate the incidences of the complications of diabetes, this being particularly important for severe visual loss and end-stage renal disease. Overall survival's medium-term modelling appeared good, but there was uncertainty about its longer-term modelling. Costs provided by the National Health Service Supply Chain suggest that hybrid closed loop is around an annual average of £1500 more expensive than continuous subcutaneous insulin infusion + continuous glucose monitoring, this being a pooled comparator of 90% continuous subcutaneous insulin infusion + intermittently scanned continuous glucose monitoring and 10% continuous subcutaneous insulin infusion + real-time continuous glucose monitoring due to clinical effectiveness estimates not being differentiated by continuous glucose monitoring type. This net cost may increase by around a further £500 for some systems. The Evidence Assessment Group base case applies the estimate of -0.29% glycated haemoglobin for hybrid closed loop relative to continuous subcutaneous insulin infusion + continuous glucose monitoring. There was no direct evidence of an effect on symptomatic or severe hypoglycaemia events, and therefore the Evidence Assessment Group does not include these in its base case. The change in glycated haemoglobin results in a gain in undiscounted life expectancy of 0.458 years and a gain of 0.160 quality-adjusted life-years. Net lifetime treatment costs are £31,185, with reduced complications leading to a net total cost of £28,628. The cost-effectiveness estimate is £179,000 per quality-adjusted life-year. Conclusions: Randomised controlled trials of hybrid closed-loop interventions in comparison with continuous subcutaneous insulin infusion + continuous glucose monitoring achieved a statistically significant improvement in glycated haemoglobin per cent in time in range between 3.9 and 10 mmol/l, and in hyperglycaemic levels. Study registration: This study is registered as PROSPERO CRD42021248512. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR133547) and is published in full in Health Technology Assessment; Vol. 28, No. 80. See the NIHR Funding and Awards website for further award information.

Aim: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost-effectiveness of SNM in children and adults with refractory idiopathic slow-transit constipation (STC). Method: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost-effectiveness outcomes, trial- and model-based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost-effectiveness outcomes were, respectively, adverse events and incremental cost-effectiveness ratios. Results: Of 1390 records reviewed, 67 studies were selected for full-text screening. For effectiveness, one cross-over and one parallel-group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial-based economic evaluation was included, which concluded that SNM was not cost-effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. Conclusion: Evidence for the (cost-)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported.

BACKGROUND: Group trauma-focused cognitive behavior therapy (TF-CBT) is widely used to treat post-traumatic stress disorder (PTSD) in children and adolescents. However, the available evidence remains unclear. METHOD: PubMed, EMBASE, Cochrane, Web of Science, PsycINFO, CINAHL, ProQuest Dissertations, LILACS, and international trial registers were searched from database inception to April 30, 2022. We included randomized controlled trials (RCTs) that compared TF-CBT with any control condition for treating children and adolescents with PTSD. Analyses were performed using Review Manager version 5.3 and Stata 16.0. The risk of bias was assessed using the Cochrane Risk of Bias 2.0 tool. This study was registered with PROSPERO (CRD42020206096). RESULTS: Eleven RCTs involving 1942 patients were included. Group TF-CBT was significantly more effective than other treatments at post-treatment (standardized mean difference [SMD]: -0.43, 95% confidence interval [CI]: -0.65 to -0.22), follow-up (SMD: -0.33, 95% CI: -0.52 to -0.13), and in relieving depressive symptoms (SMD: -0.29, 95% CI: -0.49 to -0.09), but not in terms of acceptability. Subgroup analyses showed that group TF-CBT was superior to other treatments in studies including children with post-traumatic stress symptoms (PTSS) (SMD: -0.54, 95% CI: -0.79 to -0.28) and psychiatric comorbidities (SMD: -0.48, 95% CI: -0.72 to -0.23). LIMITATIONS: The small sample sizes of identified studies limited some findings. CONCLUSION: When considering effectiveness at post-treatment and follow-up or the reduction of depressive symptoms, group TF-CBT could be a good choice for children and adolescents with PTSD. Among these patients, those with PTSS or psychiatric comorbidities may benefit the most.

Background: Screening with mammography aims to detect breast cancer before clinical symptoms appear. Among people with dense breasts, some cancers may be missed using mammography alone. The addition of supplemental imaging as an adjunct to screening mammography has been suggested to detect breast cancers missed on mammography, potentially reducing the number of deaths associated with the disease. We conducted a health technology assessment of supplemental screening with contrast-enhanced mammography, ultrasound, digital breast tomosynthesis (DBT), or magnetic resonance imaging (MRI) as an adjunct to mammography for people with dense breasts, which included an evaluation of effectiveness, harms, cost-effectiveness, the budget impact of publicly funding supplemental screening, the preferences and values of patients and health care providers, and ethical issues. Methods: We performed a systematic literature search of the clinical evidence published from January 2015 to October 2021. We assessed the risk of bias of each included study using the Cochrane Risk of Bias or RoBANS tools, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature review and conducted cost-effectiveness analyses with a lifetime horizon from a public payer perspective. We also analyzed the budget impact of publicly funding supplemental screening as an adjunct to mammography for people with dense breasts in Ontario. To contextualize the potential value of supplemental screening for dense breasts, we spoke with people with dense breasts who had undergone supplemental screening; performed a rapid review of the qualitative literature; and conducted an ethical analysis of supplemental screening as an adjunct to mammography. Results: We included eight primary studies in the clinical evidence review. No studies evaluated contrast-enhanced mammography. Nonrandomized and randomized evidence (GRADE: Very low to Moderate) suggests that mammography plus ultrasound was more sensitive and less specific, and detected more cancers compared to mammography alone. Fewer interval cancers occurred after mammography plus ultrasound (GRADE: Very low to Low), but recall rates were nearly double that of mammography alone (GRADE: Very low to Moderate). Evidence of Low to Very low quality suggested that compared with supplemental DBT, supplemental ultrasound was more sensitive, detected more cancers, and led to more recalls. Among people with extremely dense breasts, fewer interval cancers occurred after mammography plus supplemental MRI compared to mammography alone (GRADE: High). Supplemental MRI after negative mammography was highly accurate in people with extremely dense breasts and heterogeneously dense breasts in nonrandomized and randomized studies (GRADE: Very Low and Moderate). In people with extremely dense breasts, MRI after negative mammography detected 16.5 cancers per 1,000 screens (GRADE: Moderate), and up to 9.5% of all people screened were recalled (GRADE: Moderate). Contrast-related adverse events were infrequent (GRADE: Moderate). No study reported psychological impacts, breast cancer-specific mortality, or overall mortality.We included nine studies in the economic evidence, but none of the study findings was directly applicable to the Ontario context. Our lifetime cost-effectiveness analyses showed that supplemental screening with ultrasound, MRI, or DBT found more screen-detected cancers, decreased the number of interval cancers, had small gains in life-years or quality-adjusted life-years (QALYs), and was associated with savings in cancer management costs. However, supplemental screening also increased imaging costs and the number of false-positive cases. Compared to mammography alone, the incremental cost-effectiveness ratios (ICERs) for supplemental screening with handheld ultrasound, MRI, or DBT for people with dense breasts were $119,943, $314,170, and $212,707 per QALY gained, respectively. The ICERs for people with extremely dense breasts were $83,529, $101,813, and $142,730 per QALY gained, respectively. In sensitivity analyses, the diagnostic test sensitivity of mammography alone and of mammography plus supplemental screening had the greatest effect on ICER estimates. The total budget impact of publicly funding supplemental screening with handheld ultrasound, MRI, or DBT for people with dense breasts over the next 5 years is estimated at $15 million, $41 million, or $33 million, respectively. The corresponding total budget impact for people with extremely dense breasts is $4 million, $10 million, or $9 million.We engaged directly with 70 people via interviews and an online survey. The participants provided diverse perspectives on broad access to supplemental screening for people with dense breasts in Ontario. Themes discussed in the interviews included self-advocacy, patient-doctor partnership, preventive care, and a shared preference for broad access to screening modalities that are clinically effective in detecting breast cancer in people with dense breasts.We included 10 studies in the qualitative evidence rapid review. Thematic synthesis of these reports yielded three analytical themes: coming to know and understand breast density, which included introductions to and making sense of breast density; experiences of vulnerability, which influenced or were influenced by understandings and misunderstandings of breast density and responses to breast density; and choosing supplemental screening, which was influenced by knowledge and perception of the risks and benefits of supplemental screening, and the availability of resources.The ethics review determined that the main harms of supplemental screening for people with dense breasts are false-positives and overdiagnosis, both of which lead to unnecessary and burdensome health care treatments. Screening programs raise inherent tensions between individual- and population-level interests; they may yield population-level benefit, but are statistically of very little benefit to individuals. Entrenched cultural beliefs about the value of breast cancer screening, combined with uncertainty about the effects of supplemental screening on some outcomes and the discomfort of many health care providers in discussing screening options for people with dense breasts suggest that it may be difficult to ensure that patients can provide informed consent to engage in supplemental screening. Funding supplemental screening for people with dense breasts may lead to improved equity in the effectiveness of identifying cancers in people with dense breasts (compared to mammography alone), but it is not clear whether it would lead to equity in terms of improved survival and decreased morbidity. Conclusions: Supplemental screening with ultrasound, DBT, or MRI as an adjunct to mammography detected more cancers and increased the number of recalls and biopsies, including false-positive results. Fewer interval cancers tended to occur after supplemental screening compared to mammography alone. It is unclear whether supplemental screening as an adjunct to mammography would reduce breast cancer-related or overall mortality among people with dense breasts.Supplemental screening with ultrasound, DBT, or MRI as an adjunct to mammography in people aged 50 to 74 years improved cancer detection but increased costs. Depending on the type of imaging modality, publicly funding supplemental screening in Ontario over the next 5 years would require additional total costs between $15 million and $41 million for people with dense breasts, and between $4 million and $10 million for people with extremely dense breasts.The people we engaged with directly valued the potential clinical benefits of supplemental screening and emphasized that patient education and equitable access should be a requirement for implementation in Ontario. Our review of the qualitative literature found that the concept of breast density is poorly understood, both by people with dense breasts and by some general practitioners. People with dense breasts who receive routine mammography (especially those who receive health care in their nonpreferred language or are perceived to have lower economic status or health literacy) and their general practitioners may not have the awareness or knowledge to make informed decisions about supplemental screening. Some people with dense breasts experienced emotional distress from barriers to accessing supplemental screening, and many wanted to engage in supplemental screening, even when educated about its potential harms, including false-positives and overdiagnosis.Given an overall lack of robust evidence about morbidity and mortality associated with supplemental screening for people with dense breasts, it is not possible to determine whether funding supplemental screening for dense breasts delivers on the ethical duties to maximize benefits and minimize harms for populations and individuals. It is likely that existing inequities in access to breast screening and cancer treatment will persist, even if supplemental screening for dense breasts is funded. Continued efforts to address these inequities by removing barriers to screening might mitigate this concern. It will be important to identify and minimize sources of uncertainty related to benefits and risks of supplemental screening for dense breasts to optimize the capacity for everyone involved to live up to their ethical obligations. Some of these may be resolved with further evidence related to the outcomes of supplemental screening for dense breasts.