The growing advancement of innovative stem cell technologies requires careful evaluation of their economic, clinical and societal impacts. Early economic evaluations are essential for developing new medical technologies and supporting key decisions about commercialisation and market access. This scoping review explores Early Health Technology Assessment (eHTA) approaches specifically related to human stem cell technologies. By examining how eHTA can support the commercialisation of these therapies, we aim to clarify its role in optimising resource allocation and enhancing both the clinical and societal benefits of stem cell technologies. To explore the use of eHTA in the development of stem cell-related technologies, a scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - Scoping Review Extension guidelines. Systematic searches were conducted across scientific databases (MEDLINE, International HTA database, EconLit, PAIS Index and EconPapers), grey literature sources (Overton) and through hand-searching to identify eligible articles published from inception to 14 April 2026. No limits were imposed on language. Reviewers will independently record data from eligible studies using a standard data abstraction form. The gathered information will be synthesised both quantitatively and narratively. Formal ethical approval is not required, as this study does not involve the collection of primary data. The findings will be shared through professional stem cell networks, published in national and international health technology assessment conference proceedings and submitted for open-access, peer-reviewed publication.
Chronic diseases, such as diabetes, hypertension and cardiovascular diseases, represent a significant burden on global health systems. Health information technology (HIT) offers innovative solutions to improve disease management, patient outcomes and healthcare efficiency. However, the diverse applications and impacts of HIT in chronic disease management are not well understood. The objective of this scoping review is to assess the extent and type of evidence on the role of HIT in enhancing chronic disease management. This protocol outlines a scoping review to assess the extent and nature of the evidence on the role of HIT in managing chronic diseases. The review will be conducted in accordance with the JBI methodology for scoping reviews. This review will include studies involving adult patients with chronic diseases. The focus will be on various HIT interventions, including electronic health records (EHRs), telehealth services, mobile health (mHealth) applications, remote monitoring devices and health information exchanges (HIEs). Studies conducted in primary care, hospital and community health settings will be considered. Exclusions will include studies focused on paediatric populations or non-digital health interventions. We will include quantitative, qualitative and mixed-methods studies published from January 2013 to December 2024. A comprehensive search will be conducted across PubMed, Cumulative Index of Nursing and Allied Health Literature (CINAHL), Scopus and Google Scholar. Reference lists of included studies will be screened for additional sources. Two independent reviewers will screen titles, abstracts and full texts, extract data and resolve discrepancies through discussion or consultation with a third reviewer. The study is scheduled to begin in May 2025 and conclude by November 2025, and the process will be documented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram. The data will be presented as tables, charts and a narrative summary. As this review involves the analysis of publicly available literature, ethical approval is not required. The results will be disseminated via peer-reviewed publications, conference presentations and engagements with stakeholders involved in chronic disease care and digital health policy. The authors will also explore opportunities to share supplementary materials in open-access repositories to promote transparency and reproducibility.
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide, with a rising burden. Patients are mainly older adults with limited self-management abilities due to low education and cognitive decline. Systematic health education is key to improving disease knowledge and self-management; however, current programs lack standardized content, delivery, and implementation. To systematically search, appraise, and synthesize the best evidence on COPD health education, providing healthcare professionals with a rational basis for improving patients' disease knowledge and home-based self-management. This study was registered with the Open Science Framework. Following the "6S" evidence pyramid model and a top-down principle, we systematically searched the following databases and websites from inception to November 18, 2025: BMJ Best Practice, UpToDate, Cochrane Library, National Institute for Health and Care Excellence, Registered Nurses' Association of Ontario, Medlive, Guidelines International Network, American Thoracic Society, European Respiratory Society, Global Initiative for Chronic Obstructive Lung Disease, China National Knowledge Infrastructure, Wanfang Data, VIP Database, Sinomed, PubMed, Embase, and Web of Science. We included clinical practice guidelines, systematic reviews, and expert consensus. Quality was assessed using the AGREE II and JBI checklists. Evidence levels and recommendations were determined using the JBI Pre-grading System (2014). Twenty-one publications were included (nine guidelines, eight systematic reviews, and four expert consensuses). Thirty-one evidence items were extracted and grouped into seven themes: educational principles, providers, recipients, methods, objectives, core content, and outcome assessment. Effective COPD health education should shift from one-way knowledge transfer to patient-empowerment-based, interactive models. The content must be tailored to local resources, culture, and health literacy. A closed-loop "education-assessment-feedback" system, multidisciplinary teams, and smart technologies are recommended. Future research should focus on resource-limited settings, multidisciplinary implementation strategies and long-term digital intervention outcomes.
Violence against women and against children are human rights violations with lasting harms to survivors and societies at large. Intimate partner violence (IPV) and sexual violence against children (SVAC) are two major forms of such abuse. Despite their wide-reaching effects on individual and community health, these risk factors have not been adequately prioritised as key drivers of global health burden. Comprehensive x§and reliable estimates of the comparative health burden of IPV and SVAC are urgently needed to inform investments in prevention and support for survivors at both national and global levels. We estimated the prevalence and attributable burden of IPV among females and SVAC among males and females for 204 countries and territories, by age and sex, from 1990 to 2023, as part of the Global Burden of Diseases, Injuries, and Risk Factors Study 2023. We searched several global databases for data on self-reported exposure to IPV and SVAC and undertook a systematic review to identify the health outcomes associated with each of these risk factors. We modelled IPV and SVAC prevalence using spatiotemporal Gaussian process regression, applying data adjustments to account for measurement heterogeneity. We employed burden-of-proof methodology to estimate relative risks for outcomes associated with IPV and SVAC. These estimates informed the calculation of population attributable fractions, which were then used to quantify disability-adjusted life-years (DALYs) attributable to each risk factor. Globally, in 2023, we estimated that 608 million (95% uncertainty interval 518-724) females aged 15 years and older had ever been exposed to IPV, and 1·01 billion (0·764-1·48) individuals aged 15 years and older had experienced sexual violence during childhood. 18·5 million (8·74-30·0) DALYs were attributed to IPV among females and 32·2 million (16·4-52·5) DALYs were attributed to SVAC among males and females in 2023. IPV and SVAC were among the top contributors to the global disease burden in 2023, particularly among females aged 15-49 years, ranking as the fourth and fifth leading risk factors, respectively, for DALYs in this group. Among the eight health outcomes found to be associated with IPV, anxiety disorders and major depressive disorder were the leading causes of IPV-attributed DALYs, accounting for 5·43 million (-1·25 to 14·6) and 3·96 million (1·71 to 6·92) DALYs in 2023, respectively. SVAC was associated with 14 health outcomes, including mental health disorder, substance use disorder, and chronic and infectious disease outcomes. Self-harm and schizophrenia were the leading causes of SVAC-attributed burden, with SVAC accounting for 6·71 million (2·00 to 12·7) DALYs due to self-harm and 4·15 million (-1·92 to 13·1) DALYs due to schizophrenia in 2023. IPV and SVAC are substantial contributors to global health burden, and their health consequences span a variety of individual health outcomes. Importantly, mental health disorders account for the greatest share of disease burden among survivors. Investing in prevention of these avoidable risk factors has the potential to avert millions of DALYs and considerable premature mortality each year. Our findings represent strong evidence for global and national leaders to elevate IPV and SVAC among public health priorities. Sustained investments are needed to prevent IPV and SVAC and to implement interventions focused on supporting the complex social and health needs of survivors. Gates Foundation.
The integration of digital health technologies in gastrointestinal (GI) endoscopy presents opportunities to enhance patient experience, an important dimension of care quality. This systematic review aims to evaluate the impact of digital health interventions on patient satisfaction and experience in outpatient endoscopy settings. A systematic review and narrative synthesis were conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines and the Grading of Recommendations Assessment, Development and Evaluation approach. PubMed/Medline, EMBASE, PsycInfo, and Cochrane databases were searched through 9 March 2023. Studies were eligible if they involved adult patients (≥18 years) undergoing outpatient colonoscopy or gastroscopy and in English. Interventions included any form of educational digital health technology aimed at enhancing healthcare delivery. Telehealth studies were not included. Two independent reviewers extracted data and assessed risk of bias, using the Mixed Methods Appraisal Tool. A mixed-method approach was employed for the narrative synthesis, focusing on the primary outcome of patient experience and satisfaction. Nine studies met the inclusion criteria, all assessing patient satisfaction rather than experience. Five studies reported improved satisfaction associated with digital interventions, three showed no significant change, and one lacked statistical analysis. Interventions ranged from smartphone applications to online educational resources, and satisfaction measurement tools varied significantly. Overall, the evidence was characterised by heterogeneity and very low methodological quality. Digital health interventions may have a positive impact on patient satisfaction in GI endoscopy, although evidence quality is very low and outcome measurement is inconsistent. Future research should focus on standardising measures of patient experience and satisfaction, ensuring robust study designs to inform the integration of digital health tools into endoscopy practice. CRD42023428609.
Decolonising global health requires rethinking how evidence is generated, valued and applied to address colonial legacies and power imbalances in systems, practices and research. This analysis draws on findings from a scoping review and synthesises existing literature to examine how decolonisation principles can be integrated into implementation science. We propose three conceptual shifts: (1) Embedding contextually and locally driven intervention approaches, (2) Centring participatory, equity-focused methodologies that redistribute authority and (3) Expanding metrics to capture power, authorship equity, adaptability and legitimacy. These shifts reposition implementation science as a transformative practice supporting structural change. Operationalising these shifts through policy-aligned, locally led research, equitable mentorship and technologies co-designed with communities provides a practical framework for researchers, funders and policymakers to embed decolonisation into implementation science, ensuring interventions are contextually relevant, equitable and socially just.
Head and neck cancer (HNC) affects the mouth, throat, salivary glands, voice box, nose or sinuses. Every year, over 12 000 people in the UK are diagnosed with HNC. Neck dissection is a key, surgical component of patient care. However, many people experience postoperative restriction in shoulder and neck movements, pain, fatigue and low mood, with only half ever returning to work. Getting Recovery Right After Neck Dissection (GRRAND) is a two-arm, multicentre, pragmatic randomised controlled trial. The trial aims to compare clinical and cost-effectiveness of a personalised physiotherapy programme (GRRAND programme) versus usual practice, National Health Service (NHS), postdischarge care.The planned sample size is 390 participants. Participants will be recruited from across UK sites and followed up for 12 months. The primary outcome is the shoulder pain and disability index at 12 months. Economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data, including pain, function, health-related quality of life, mental well-being, health resource use and adverse events, will be collected at 6 weeks, 3, 6 and 12 months, with exercise adherence at 6 weeks. A process evaluation will determine how GRRAND is implemented, delivered and received across clinical settings, exploring what works, for whom and under what conditions. Analysis will be on an intention-to-treat basis and reported inline with the Consolidated Standards of Reporting Trials statement. The trial was approved by the London-Brent Research Ethics Committee (ref: 24/LO/0722) on 15 October 2024. Trial results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries and social media. This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials checklist. ISRCTN13855775.
Prehabilitation transforms the preoperative waiting period into an opportunity for patients to actively improve their health before surgery. With surgical populations ageing and presenting with increasing frailty, patient prioritised outcomes, such as postoperative complications and disability, affect >20% of patients undergoing major surgery, resulting in substantial healthcare costs. This review combines the current evidence for prehabilitation components, including exercise, and respiratory, nutritional, cognitive, and psychosocial interventions. Although respiratory prehabilitation showed high certainty evidence for reducing postoperative pulmonary complications after major surgery, other components showed promising but lower certainty benefits. Multimodal prehabilitation, especially when exercise and nutrition are combined, seems to be most effective for improving clinical and patient centred outcomes. Significant knowledge gaps remain, however, about optimal programme design, delivery models, target populations, and strategies to maximise adherence. Patient perspectives emphasise the importance of individualised coaching or support from healthcare professionals, or both, home based accessibility, and collaborative care. Future research should include a focus on pragmatic multicentre trials with robust cost effectiveness analyses to support implementation in the health system of effective, scalable prehabilitation programmes that can meaningfully improve outcomes for surgical patients. Opportunities to enhance the effectiveness and reach of prehabilitation include exploiting existing and emerging technologies, as well as optimising participant support to maximise adherence.
Endometriosis is a chronic, inflammatory and oestrogen-dependent disease frequently causing infertility. Assisted reproductive technologies (ART) are often required to achieve pregnancy, especially in women with advanced endometriosis. To date, there is no randomised controlled trial (RCT) exploring reproductive outcomes after first-line surgery followed by ART versus first-line ART in women with stage III-IV endometriosis. The aim in this study is to investigate if endometriosis surgery prior to ART in women with endometriosis stage III-IV and infertility results in improved reproductive outcomes compared with first-line ART. A national multicentre prospective open label RCT including 350 subjects with stage III-IV endometriosis and infertility. Women aged 18-38 will be randomised 1:1 to endometriosis surgery prior to ART or first-line ART. Follow-up until 3 years from the first treatment.The primary outcome is the cumulative live birth rate 3 years after inclusion. Secondary outcomes are cumulative pregnancy rate, reproductive outcomes per in vitro fertilisation cycle, miscarriage rate, time to pregnancy and live birth, plasma progesterone levels on the day of frozen embryo transfer in hormone replacement cycles, obstetrical outcomes and complications, infections after oocyte retrieval, intraoperative and postoperative complications, pain, quality of life and cost-effectiveness. The study protocol, patient information and informed consent are approved by Swedish Ethical Review Authority (dnr: 2024-04293-01, approved 7 October 2024, amendment, dnr: 2025-03699-02, approved 17 June 2025).An interim analysis is scheduled to ensure the safety of the interventions.The results of Endo-SOFT (Endometriosis: Surgery Or Fertility Treatment) will be published in scientific journals and are expected to influence clinical guidelines. ClinicalTrials.gov, NCT07240363.
Despite an increasing amount of research related to gender-affirming treatment (GAT) outcomes among transgender and gender-diverse (TGD) people (ie, people who experience discomfort or distress in the misalignment between their gender and sex assigned at birth) in recent years, the evidence base for current recommendations is suboptimal. One contributing factor is the heterogeneity in the outcomes and outcome measures used. This study seeks to address this challenge by developing a foundational core outcome set (COS) to be used for TGD adults receiving GAT in Sweden. Recommendations from the Core Outcome Measures in Effectiveness Trials initiative will be used to address this aim in four phases. Phase 1, an umbrella review of peer-reviewed literature and international guidelines in GAT will be conducted to identify relevant outcomes. In phase 2, we will solicit input from TGD individuals through the review of patient and interest organisations' reports and an anonymous survey to identify outcomes of personal significance. In phase 3, using the Delphi method, 2-3 rounds of assessment will be conducted where researchers, healthcare professionals, policy-makers and TGD adults rate the identified outcomes by perceived importance. In phase 4, a consensus meeting will convene representatives from all stakeholder groups to finalise the COS. The results of this study will consist of a COS for GAT regarding TGD adults in Sweden. Participant survey responses will be evaluated using interpretive analysis to identify core outcomes. During each of the Delphi rounds, Likert-type scale ratings will be aggregated for outcomes to advance or be eliminated in each round. The study has received ethical approval by the Swedish Ethical Review Authority (Umeå medicine department, Registration number: 2024-04672-01). The results of this study will be published open-access and disseminated through TGD interest organisations and a Swedish research network for gender dysphoria. COMET registration number 3223.
To develop and user-test a patient decision aid for people diagnosed with degenerative cervical myelopathy and who are considering surgery. Mixed-methods study describing the development of a patient decision aid. A draft decision aid was developed by a multidisciplinary steering group (including study authors with degenerative cervical myelopathy, health professionals and researchers) informed by the best available evidence, authorship consensus and existing patient decision aids. Patient-participants and health professional-participants who manage people with degenerative cervical myelopathy were recruited through social media and the steering group's research and practice network. Quantitative questionnaires were used to gather baseline data, descriptive feedback, refine the decision aid and assess its acceptability. Qualitative semi-structured interviews were conducted online to gather feedback on the decision aid and were analysed using reflexive thematic analysis. We conducted 32 interviews: 19 patient-participants and 13 health professional-participants who manage people with degenerative cervical myelopathy (neurosurgeons, neurologists, physiotherapists, orthopaedic surgeons, general practitioners, rehabilitation and pain specialists and consultant occupational physicians and chiropractors). Participants were from 10 countries (Australia, Canada, Cyprus, Germany, Ireland, New Zealand, Sweden, Switzerland, United Kingdom and USA). Most participants rated the decision aid's acceptability as good-to-excellent and agreed with most aspects of the decision aid (eg, defining degenerative cervical myelopathy, management recommendations, potential benefits and harms, questions to consider asking a health professional). Our patient decision aid was rated as an acceptable tool by both health professional-participants who treat degenerative cervical myelopathy and patient-participants with lived experience of degenerative cervical myelopathy. This decision aid can be used by clinicians and people with degenerative cervical myelopathy to help with shared decision making following a diagnosis of degenerative cervical myelopathy. A study testing the potential benefits of this decision aid in a clinical setting is recommended.
To retrieve, evaluate, and summarize the evidence related to nutritional risk screening and assessment in adult critically ill patients, providing an evidence-based decision-making reference for clinical healthcare professionals. This study was an evidence summary followed by the evidence summary reporting standard of Fudan University Center for Evidence-based Nursing. According to the '6S' model of evidence resources, evidence on nutritional risk screening and assessment in adult critically ill patients was retrieved, including clinical decision-making, best practices, guidelines, evidence summaries, expert consensus, and systematic evaluations. Up to date, BMJ Best Practice, Cochrane Library, Joanna Briggs Institute (JBI), Embase, PubMed, WanFang Medical, China Biomedical Literature Database, CNKI, and relevant professional society websites including the National Institute for Health and Care Excellence (NICE), GIlN, the National Guideline Clearinghouse, and Yi Maitong were searched from the establishment of these databases to Dec. 2024. Eleven literature sources were included, comprising 8 guidelines, 2 expert consensuses, and 1 evidence summary. Through rigorous synthesis, 18 best practice recommendations were distilled across eight critical domains: multidisciplinary team formation, screening targets, screening timing, screening instruments, screening frequency, assessment targets, assessment core parameters, and assessment frequency. This study summarizes the current best evidence regarding nutritional risk screening and assessment in adult critically ill patients, providing optimal evidence support for standardizing nutritional risk screening and assessment in this population. In clinical practice, it is essential to select the best evidence for localized and individualized application while continuously updating the evidence to standardize nursing practice. Clinical medical staff are encouraged to use evidence-based recommendations for the screening and assessment of nutritional risks in adult critically ill patients. By implementing these best evidence practices, healthcare professionals can enhance patient care and improve clinical outcomes, ensuring that nutritional needs are effectively addressed. The effective screening and assessment of nutritional risk in critically ill patients are crucial for optimizing patient outcomes. This study summarizes 18 pieces of best evidence concerning nutritional risk screening and assessment, highlighting their importance in clinical practice. Implementing these recommendations can enhance the quality of nutritional care, reduce complications, and ensure that patients receive appropriate nutritional interventions tailored to their needs. By focusing on these best practices, healthcare providers can significantly improve the management of nutrition in critically ill patients. This research followed the evidence summary reporting specifications of the Fudan University Center for Evidence-based Nursing. The registration number is 'ES20221368'.
Coronary artery bypass grafting (CABG) remains one of the most commonly performed cardiac surgeries worldwide. Despite surgical advancements, a significant proportion of patients experience psychological distress following surgery, with depression being particularly common. Current evidence regarding the effectiveness of preoperative psychological interventions in improving postoperative mental health outcomes remains inconclusive. There is a critical need for predictive models that can identify patients at risk of developing clinically significant depressive symptoms (CSDSs) and related psychological conditions after CABG. This multicentre observational study aims to develop and validate prognostic models for predicting CSDSs and other psychological outcomes, including anxiety, post-traumatic stress symptoms and quality of life, 6 weeks after elective CABG surgery. The study will recruit 300 adult patients undergoing elective CABG (with or without valve intervention) across two Swiss hospitals. Data collected will include demographic, clinical, psychometric, inflammation-related and interoceptive variables. A training set (n=200) will be used to develop predictive models using machine learning, while a held-out test set (n=100) will be used for model validation. The primary outcome prediction will focus on CSDSs, assessed using the Patient Health Questionnaire-9 (PHQ-9), with analyses conducted both categorically (PHQ-9 total score ≥10) and continuously as complementary approaches. Secondary models will address anxiety, using the General Anxiety Disorder Scale-7, post-traumatic stress, using the post-traumatic stress disorder checklist for Diagnostic and Statistical Manual of Mental Disorders-5 and health-related quality of life, using the 12-item Short Form Survey. A simplified 'light solution' model with fewer predictors will also be developed for broader applicability. This study will address an important gap in perioperative mental healthcare by identifying key predictors of psychological morbidity following CABG, particularly CSDSs. The resulting models may inform future screening and preventive strategies and improve postsurgical outcomes through early identification and intervention in high-risk individuals. The responsible ethics committee has reviewed and approved this project (Kantonale Ethikkommission Zürich, BASEC number: 2023-02040). The study minimises participant burden by integrating brief validated instruments and limiting psychiatric interviews to relevant outcomes, while ensuring ethical safeguards and respect for participant rights (including written consent). Results will be shared through peer-reviewed publications, conference presentations and stakeholder meetings involving clinicians and mental health professionals. Findings will also be communicated to participating centres and patient communities in accessible formats.
Patient safety incidents during healthcare cause a high burden and mortality, but many go unreported. Involving patients and caregivers in the identification and reporting of safety incidents would add value to the current incident reporting systems used by health professionals. Identifying and analysing patient safety incidents is essential to prevent future events, allowing organisations to apply a learning-from-error approach and to implement improvement plans. Patient-Reported Incident Measures are tools for patients and caregivers to report safety issues related to their healthcare. In accordance with WHO's patient safety taxonomy, the term patient safety incidents is used throughout this protocol to encompass events that do and do not reach the patient, including what are commonly referred to as near misses and adverse events. We aim to identify and describe the published literature about tools for patients or caregivers to report patient safety incidents in healthcare. We will conduct a scoping review. We have developed inclusion criteria using the PCC (population, concept and context) format, where population includes adult patients or caregivers; concept refers to documents describing formal tools used to report patient safety incidents; and context includes any healthcare setting, such as hospitals or mental health centres, during or immediately after care. The scoping review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. Evidence sources include primary research, systematic reviews, meta-analyses, conference abstracts, letters, guidelines, as well as policy documents, reports, blogs and websites, without language restriction. An initial database search in Medline, Embase, CINAHL, and Cochrane Library from database inception up to June 2023 identified 4500 initial citations, of which 4103 were selected for evaluation after duplicates were removed. We will supplement the search by checking the reference lists of included studies for additional sources of evidence and an additional search in Google to identify non-peer-reviewed documents. This initial search will be updated before completing the review. We will use a self-created data collection form for data extraction and perform a narrative synthesis to integrate and summarise the review findings. We will describe the general characteristics of the tool: setting, scope, format, content, type of patient safety incident and severity, the moment of notification, relation to patient safety incident reporting and learning systems, development process, testing, validation, or piloting, among other characteristics. As a result of this scoping review, we intend to provide an index of patient/caregiver-reported safety notification tools and a list of descriptive or evaluation studies. We will only use published data. Approval from the human research ethics committee is not required. The results of this scoping review will be submitted for publication in an international peer-reviewed journal and scientific meetings. Findings will also be disseminated through digital science platforms and academic social media.
Recovery after extremity fracture is influenced by injury-related impairments, functional capacity, symptom severity and psychosocial well-being, emphasising the need for patient-reported outcome measures (PROMs). Despite increasing adoption of Patient-Reported Outcomes Measurement Information System (PROMIS) and legacy PROMs in orthopaedic research, substantial knowledge gaps remain regarding their measurement properties, comparability and clinical utility, particularly in fracture populations. Our aim is to develop meaningful guidance to clinicians regarding the use of PROMs in treating orthopaedic fracture patients. A prospective cohort of 1500 patients across 14 centres presenting with isolated extremity fractures being treated operatively or non-operatively will be recruited prospectively. We will aim to recruit 300 patients for each of five fracture types: isolated hip, tibial shaft, ankle/pilon, proximal humerus and distal radius fracture. All procedures and management will be performed according to the site's standard of care and treatment protocol. For patients treated non-operatively, the index visit (first study assessment) will be performed at the first orthopaedic treatment encounter (eg, emergency department visit or outpatient fracture clinic). Surgically treated patients will have PROMs collected anytime from the day of the surgery up to discharge from hospital for the index visit. Follow-up visits will be performed at 2-3 weeks, 6-8 weeks, 10-13 weeks, 6 months and 1 year after the index visit. At baseline, we will document injury data, demographic and sociodemographic data, and radiographic classification using the AO classification system. Patient-perceived functioning will be assessed with PROMIS Physical Function (PF), PROMIS Upper Extremity, PROMIS Global Health, Knee and Injury Osteoarthritis Outcome Score-12, Hip Disability and Osteoarthritis Outcome Score-12, Foot and Ankle Ability Measure and Quick Disabilities of the Arm, Shoulder and Hand. The following domains and PROMs will also be captured: symptoms of anxiety and depression (PROMIS Anxiety; PROMIS Depression), patient activation (Patient Activation Measures (PAM)-10) and a patient's ability to fulfil social roles (PROMIS Social Roles).The range and normative limits of the PROMs collected will be defined using standard descriptive statistics. We will crosswalk or validate PROMIS measures with legacy instruments for PF using an Item Response Theory (IRT)-based linking model and compare it to non-IRT models (such as equipercentile linking). Lastly, we will assess the PROM-based recovery trajectory after fracture, overall and after adjusting for relevant demographic, clinical or biopsychosocial factors. Ethics approval for this study was granted from the local Ethics Committees or Institutional Review Board at each of the participating sites prior to patient enrolment. Austin: Institutional Review Board University of Texas at Austin, STUDY00000262; Boston: Mass General Brigham, 2019P000397; Los Angeles: Cedars-Sinai, Office of Research Compliance and Quality Improvement, STUDY00000081; Miami: University of Miami Human Subject Research Office, 20221353; Bogotá: Comité Corporativo de Ética en Investigación, CCEI-15607-2023; Berlin: GoFitFast: under Homburg approval; Recovery/Linking: Ethikkommission Charité Universitätsmedizin Berlin, EA2/026/21; Homburg: GoFitFast: Ethikkommission der Ärztekammer des Saarlandes, 232/19; Recovery/Linking: under Charité approval; Murnau: under umbrella from Homburg and Charité, GoFitFast: under Homburg approval, Recovery/Linking: under Charité approval; Tübingen: GoFitFast: Ethik-Kommission, Universitätsklinikum Tübingen, 393/2022BO2; Freiburg: Ethik-Kommission Albert-Ludwigs-Universität Freiburg, 21-1401; Rostock: Ethikkommission an der Universitätsmedizin Rostock, A 2024-0113; Innsbruck: Ethikkommission der Medizinischen Universität Innsbruck, 1258/2021; Oxford: HRA and Health and Care Research Wales, 20/EE/0051; London: HRA and Health and Care Research Wales, 20/EE/0051; Groningen: Medical Ethics Review Board University Medical Center Groningen, METc 2023/187 16882; Non-WMO waiver; Zwolle: Medical Ethics Review Board University Medical Center Groningen, METc 2023/187 16882; Non-WMO waiver. The results of this study will be published in peer-reviewed journals and presented at different conferences. NCT04113044.
Lung cancer (LC) is the leading cause of cancer-related mortality worldwide, primarily due to diagnosis at advanced stages. Although low-dose computed tomography (LDCT) screening reduces lung cancer mortality in high-risk populations, current screening programmes are largely restricted to individuals defined by age and smoking history. This approach excludes never-smokers and individuals with non-smoking-related risk factors, limiting the equity, efficiency and scalability of lung cancer screening. The LUng Cancer risk factors and their Impact Assessment (LUCIA) project aims to overcome these limitations by developing personalised lung cancer risk prediction models and evaluating novel non-invasive technologies for early detection within a risk-adapted screening strategy. LUCIA is a multicentre, observational, longitudinal cohort study that will recruit approximately 4000 participants across four European regions: Andalusia and the Basque Country (Spain), Liège (Belgium) and Riga (Latvia). The study population includes smokers, never-smokers and reduced smokers with low-to-moderate lung cancer risk. All participants will initially enter phase 1 (wide population screening) and may transition to phase 2 (precision screening) or phase 3 (diagnosis) based on LDCT findings, results from non-invasive screening devices and artificial intelligence-based risk prediction models. Participants will be followed up for 24 months, with assessments at baseline and at 6, 12 and 24 months. Data collection includes sociodemographic characteristics, medical history, environmental and occupational exposures, lifestyle factors, spirometry, multi-omics profiles and outputs from novel non-invasive devices, including a breath analyser, spectrometry-on-card and a skin-applied volatile organic compound sensing patch. The study will develop and validate integrated lung cancer risk prediction models and evaluate the diagnostic performance of these technologies to support population stratification and personalised screening. The study will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable national and European regulations. Ethical approval has been obtained from the relevant ethics committees in all participating countries. Written informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed open-access publications, scientific conferences and communication with public health stakeholders. ClinicalTrials.gov, NCT06473870.
Children with cleft lip and palate face more complex stressful situations in the perioperative period due to their underdeveloped systems and relatively weaker resistance to various injurious stimuli. The concept of enhanced recovery after surgery (ERAS) offers a novel perspective on the perioperative management of pediatric patients with cleft lip and palate. This narrative review aimed to search, evaluate, and summarize the best evidence for ERAS in children with cleft lip and palate, and provide reference for clinical perioperative nursing practice. We searched the databases of The British Medical Journal (BMJ), UpToDate, The Cochrane Library, Guidelines International Network (GIN), Scottish Intercollegiate Guidelines Network (SIGN), Joanna Briggs Institute (JBI), Medlive, American Cleft Palate-Craniofacial Association (ACPA), Enhanced Recovery After Surgery Society, Chinese Stomatological Association (CSA), PubMed, Web of Science, Embase, Scopus, SinoMed, China National Knowledge Infrastructure (CNKI), Wanfang, and China Science and Technology Journal (VIP). The search covered the period from the database's inception to December 2024. This study included children undergoing congenital cleft lip and palate surgery who received perioperative ERAS interventions with evidence derived from guidelines, evidence summary, expert consensus, systematic reviews, or randomized controlled trials (RCTs), while excluding non-English/Chinese literature, incomplete methodological details or low-quality appraisal ratings, and studies with unavailable data. Quality was assessed using Clinical Guidelines Research and Evaluation System for guidelines, Critical Appraisal for Summaries of Evidence for evidence summaries, the JBI Critical Appraisal Tool for Systematic Reviews, the JBI Critical Appraisal Checklists for expert consensus, and the Cochrane Risk of Bias Tool for randomized trials. Evidence synthesis was performed using the JBI Evidence Pre-grading System (2014) to classify evidence levels (1-5), followed by recommendation grading (grade A/B). A total of 14 articles were included, including four guidelines, one technical report, two expert consensus articles, three systematic reviews, and four RCTs (covering 342 patients). The publication or update dates of these studies spanned 2019-2024, with their sources predominantly originating from the United States and China, and they covered the entire perioperative period. Through a comprehensive analysis of these studies, 17 themes and 34 recommendations were identified in total. These recommendations cover preoperative preparation (health education, nutrition, fasting), intraoperative care (anesthesia, temperature), postoperative management (pain, feeding, wound care), and discharge follow-up. This study synthesizes 34 key evidence-based recommendations for perioperative ERAS management in pediatric cleft lip and palate surgery, providing structured guidance to accelerate postoperative recovery and standardize clinical practice. Since these findings originated from several nations, institution-specific factors must be assessed prior to adoption of ERAS protocols. These factors include resource availability, local healthcare policies, multidisciplinary team engagement, and existing clinical workflows.
To comprehensively map the available evidence on interventions implemented for adult survivors following discharge from the intensive care unit (ICU). A scoping review was conducted following the methodological framework proposed by Arksey and O'Malley. A systematic search was done across Embase, Medline, Scopus, China National Knowledge Infrastructure, China Science and Technology Journal Database, Chinese Biomedical Database, Wanfang Data, ProQuest Dissertations and Theses, ClinicalTrials.gov, the Chinese Clinical Trial Register, the China Master's Theses Full-text Database and the China Doctoral Dissertation Full-text Database. Literature published between January 2000 and May 2025 was included. Studies published in English or the Chinese language on postdischarge interventions for adult ICU survivors were assessed. Two researchers independently screened the literature and extracted relevant data. 39 studies were included, reporting 14 intervention components. Common strategies included ICU experience review, physical therapy and clinical assessment. Social, peer support and survivor participation interventions were less common. Most interventions were delivered within 1 week to 6 months postdischarge, via hospital visits or phone, with nearly half using multiple formats. Digital tools such as WeChat, telehealth and virtual reality (VR) were used in some studies; 15 studies involved caregivers, and 27 were nurse-led with multidisciplinary input. Interventions primarily targeted psychological well-being, quality of life and physical function, while social recovery and healthcare utilisation were less often addressed. Current interventions are insufficiently addressing social, peer support and self-engagement needs. Future strategies should emphasise patient-centred, long-term care, with improved outcome measures and use of ICU-specific health-related quality of life tools. Integrating digital technologies could enhance access and continuity, supporting more sustainable post-ICU care.
The Society of Cardiothoracic Surgery (SCTS) in Great Britain and Ireland provides comprehensive guidelines for the management of adult mitral valve disease, addressing both surgical and transcatheter interventions. These guidelines serve as a resource for healthcare professionals, supplementing existing clinical guidelines. They emphasize the evolving complexity of mitral valve disease management, influenced by the development of new technologies, ongoing research, and randomized trials. The guidelines detail a thorough methodology, incorporating an extensive literature review and evidence assessment conducted by a clinical guidelines team. They outline best practices of preinterventional patient assessment and indications of mitral interventions, while considering the management of patient comorbidities and concomitant diseases. Detailed repair techniques for mitral regurgitation and rheumatic valve disease are provided, along with a summary of indications for emerging transcatheter and hybrid procedures, including transcatheter edge-to-edge repair, transapical neo-chordee placement, transcatheter aortic valve mitral implantation, and percutaneous mitral annuloplasty. The guidelines address postoperative mitral complications and prosthesis considerations, including up-to-date recommendations for antithrombotic management. These guidelines aim to improve patient outcomes through detailed, evidence-based recommendations and encourage the development of specialized mitral MDTs within UK practice. They provide an educational resource, clarifying the implementation of recent technologies and supporting clinical decision-making in the management of adult mitral valve disease.
Genetic variations impact drug response, driving the need for personalised medicine through pre-emptive pharmacogenetic testing. However, the adoption of pre-emptive pharmacogenetic testing for commonly prescribed drugs, such as tacrolimus, outside of tertiary hospitals is limited due to a lack of pharmacoeconomic evidence to support widespread implementation by healthcare policymakers. The iPHARMGx Consortium addresses this by developing the TRANSPGx clinical trial to assess the hypothesis that widespread adoption of a pre-emptive genotyping scheme in populations susceptible to receiving tacrolimus as immunosuppressive therapy following a kidney transplant is effective, cost-effective and feasible within the Spanish National Health System (SNHS) when compared to the standard of care tacrolimus dosing. The TRANSPGx trial is a multicentre, adaptive, randomised, controlled, pragmatic phase IV clinical trial nested within the iPHARMGx master protocol, with two parallel arms, aiming for superiority. Randomisation will be conducted on an individual basis with a centralised approach, with stratification by centre. After inclusion in the trial and completion of genotyping, subjects will be randomly allocated to either the experimental group (pharmacogenetic genotype-guided tacrolimus prescription) or the standard of care tacrolimus prescription (as deemed by the attending physician). The primary objective is to assess the effectiveness of a tacrolimus pre-emptive genotyping strategy in reaching tacrolimus target plasma concentrations after renal transplant. A total of 114 subjects will be recruited among the different participating centres, provided that no futility/efficacy boundary is reached in the prespecified interim analyses. Recruitment will be carried out during a 12-month period, and subjects will be followed for a 6-month period. The TRANSPGx trial received ethical approval on 16 January 2025 (La Paz University Hospital 2024.740). Results will be disseminated via publication in peer-reviewed journals as well as presentation at international conferences. Trial results will be submitted for publication in an open access peer-reviewed medical speciality-specific publication. Trial registration of this study can be located at both the EU Clinical Trials Register, available from https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en and https://clinicaltrials.gov. Registration on both websites was done before the enrolment of the first patient complying with European regulations. The EU Clinical Trials Register is a primary registry according to the WHO. EU CT number: 2024-5 16 596-32-00/Clinical trial Identifier (ClinicalTrials.gov): NCT06701825. Protocol V. 1.2, 8 January 2025.