Conducting clinical research in response to infectious disease outbreaks presents unique challenges. In a previous review, we identified a range of political, economic, administrative, regulatory, logistical, ethical and social (PEARLES) challenges and proposed solutions to effective implementation of outbreak research responses. Following the COVID-19 pandemic, we conducted an update to explore if solutions recommended had been implemented, or new challenges identified. We searched seven databases (Ovid MEDLINE, Global Health, Embase, and PsycINFO, Scopus, Epistemonikos, Google Scholar) and grey literature from 01/06/2018 to 28/09/2023 for studies presenting PEARLES challenges/solutions to epi/pandemic research responses.
Search Results for: Il dolore neuropatico: review
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Dolori facciali atipici
Dolore temporomandibolare – Che cos’è il dolore facciale atipico? Quali sono le cause delle algie facciali atipiche?
Dolore cronico, il guasto nascosto nel cervello
Come un’automobile, anche il cervello avrebbe una sorta di conducente capace di guidare le reazioni al dolore. Quando ci pungiamo oppure subiamo una bruciatura o comunque andiamo incontro a un…
Vitamin D levels and its influencing factors in children and adolescents in mainland China: a systematic review and meta-analysis
Objectives
Childhood vitamin D deficiency is a public health issue. This study aims to systematically evaluate vitamin D nutritional status among children and adolescents in Mainland China through a quantitative analysis of literature, providing evidence-based strategies for prevention.
Design
This is a systematic review and meta-analysis, conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Data sources
A comprehensive search strategy was implemented across eight electronic databases (PubMed, Embase, Web of Science, Cochrane Library, CNKI, VIP, Wanfang and CBM) from inception to February 2024.
Eligibility criteria
We included cross-sectional studies that measured serum 25-hydroxyvitamin D levels and analysed influencing factors (eg, age, season, region) in healthy children and adolescents aged 0–18 years in Mainland China; studies reporting prevalence data of vitamin D deficiency/insufficiency based on standardised thresholds (deficiency
Dental neglect in children and adolescents: protocol for a scoping review on strategies for identification and prevention
Introduction
Dental neglect in children and adolescents is a form of child maltreatment and can be an indicator of other forms of maltreatment. Early identification of dental neglect is essential to initiate preventive interventions and connect families to appropriate health and social services to avoid further harm and to reduce negative impacts on child development and well-being. Articles that systematically synthesise and compare models for early detection, intersectoral cooperation and care for dental neglect have not been published yet. This scoping review aims to map the evidence on strategies for the identification and prevention of dental neglect in children and adolescents.
Methods and analysis
The study is designed as a scoping review. Based on the Population, Concept and Context (PCC) scheme, the databases PubMed, PsycInfo and Scopus are searched for publications before July 2023. Publications in all languages will be considered in case an abstract in English or German is available. The review will include articles reporting on strategies for identification and prevention related to dental neglect in children and adolescents as conducted in health service and community settings. Data from included articles will be extracted to describe and categorise the available evidence. The review will follow recommendations of the Joanna Briggs Institute Reviewer’s Manual on scoping reviews and the Critical Appraisal Tool for Health Promotion and Prevention Reviews (CAT HPPR).
Ethics and dissemination
Ethical approval is not required, as no personal data will be collected in this literature-based study. The study’s findings will be disseminated through conference presentations, scientific publications and stakeholder meetings.
Synthesis of interventions using an interRAI tool to guide care management and assess intervention efficacy in older adults: protocol for a scoping review
Introduction
interRAI is a global collaboration of clinicians, researchers and policy-makers who have developed a suite of assessment tools to assess the health status and care needs of older adults in various settings (ie, home, long-term care, etc). We aim to determine how interRAI tools have been used as an intervention and to evaluate intervention efficacy in older adults (65+) across diverse healthcare settings. Importantly, given the deployment of interRAI primarily in high-income countries, we anticipate that the findings may have minimal relevance to low- and middle-income nations, where there is an immediate and urgent need for equity in geriatric assessment.
Methods and analysis
To be included, all studies must satisfy our inclusion criteria, outlined by the population (ie, older adults and/or individuals providing some element of care to older adults), intervention (ie, randomised or non-randomised), comparator (ie, with or without one) and outcome (ie, how the interRAI formed the basis of a study intervention). Our search strategy is based on previous reviews of interRAI tools, our research and clinical experience, and the expertise of a specialised librarian. In addition to PubMed, we will conduct our search without date or language restrictions in Scopus, Embase,Cumulative Index to Nursing and Allied Health Literature (CINAHL), Academic Search Premier and PsycInfo. Study screening will employ a team-based approach, with Kappa statistics >0.8 indicating ‘substantial’ agreement and an acceptable threshold. Data extraction will capture the study ID and design, as well as sample characteristics and outcomes. Reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews, with findings presented graphically and narratively.
Ethics and dissemination
Ethics approval is not required. Our knowledge dissemination strategies include traditional research avenues (ie, manuscript publications). We will also create an infographic to disperse widely and leverage existing partnerships to provide community presentations.
Registration details
https://doi.org/10.17605/OSF.IO/BGJKP
Efficacy and safety of musculoskeletal manipulations in elderly population with musculoskeletal disorders: a systematic review
Introduction
Non-pharmacological interventions, including musculoskeletal manipulations (MMs), have been proven effective for musculoskeletal disorders.
Objectives
To evaluate if MMs, including osteopathic manipulation and chiropractic care, are effective to improve quality of life, pain intensity and function in older adults with musculoskeletal disorders.
Design
Systematic review.
Data sources
A systematic search was conducted on MEDLINE/PubMed, EMBASE, Scopus, Web of Science, CINAHL, Cochrane Library, from database inception up to 2 January 2025.
Eligibility criteria
Randomised controlled trials, controlled non-randomised trials and open label trials evaluating the efficacy and safety of MM such as osteopathic manipulation, chiropractic manipulation, myofascial release, craniosacral therapy, as monotherapy or adjunctive therapies in older people (age ≥65 years) with musculoskeletal disorders. The main outcomes included pain intensity, functionality and quality of life. Additionally, other related outcomes were considered, such as medical use duration, mood, mobility, motion, strength and endurance. Finally, we considered any adverse events.
Data extraction and synthesis
Selection and data extraction were performed independently by two authors. The effect estimates for each study were performed using Review Manager V.5.14. Continuous outcomes were analysed using the mean difference (95% CI). The methodological quality of the included studies was assessed using the Cochrane Risk of Bias tool 2 (RoB 2). No meta-analysis was performed.
Results
Five parallel randomised controlled trials were included, with a total sample size of 676 participants (41.6% women with a mean age of 77.3 years): 34 with chronic pain, 265 with neck pain and 377 with low back pain. MMs were not effective in patients with chronic pain, neither in pain intensity nor in functionality. For neck pain, considering the main outcomes, only in one of the two studies was there a statistically significant improvement in neck pain intensity only at week 12 for spinal manipulative treatment (SMT)+home exercise (HE) compared with HE alone (ES=–0.90 (95% CI –1.46 to –0.34); p=0.002). For low back pain, SMT+HE showed a statistically significant reduction in pain at 12 weeks compared with HE (ES=–0.79 (95% CI –1.39 to –0.19) p=0.010. For neck pain and low back pain, no statistically significant improvement in functional status and quality of life was observed with MM compared with any control group. RoB 2 showed a high risk of bias in three studies and some concerns in the others. At the domain level, the lowest risk was observed in the randomisation process (80% with some concerns). All five studies reported adverse events, none of which were serious.
Conclusions
This review provides limited and inconclusive evidence about MM to improve quality of life, pain management and functional status in older adults with musculoskeletal disorders. However, MM appears to be generally safe and well-tolerated.
PROSPERO registration number
CRD42023473203.
Advancing health equity and the role of digital health technologies: a scoping review
Background
Health disparities persist, posing significant health, social and economic challenges. Digital health technologies (DHTs) present a promising opportunity to address these inequities and advance health equity. Despite this potential, a comprehensive and structured overview of existing frameworks and guidelines on advancing health equity and a clear understanding of the potential of DHTs in their implementation to systematically close the healthcare gap is yet to be done.
Objective
To this end, our objectives are twofold: first, to identify frameworks and guidelines that promote health equity and second, to pinpoint the role of DHTs as an avenue for their implementation. We conducted a scoping review informed by Arksey and O’Malley’s five-stage framework, methodological guidelines by the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.
Sources of evidence
A comprehensive search was conducted across seven databases on 6 December 2023: PubMed, EMBASE, Cochrane, PsycINFO, Scopus, Web of Science and WISO.
Eligibility criteria
We included primary and secondary studies published in English between 2010 and 2023 focusing on advancing health equity for priority populations.
Charting methods
For the analysis, we applied multistaged coding approaches to answer our twofold objective.
Results
The search identified 6419 studies, of which 38 met our final inclusion criteria and were included in this review. We extracted 559 recommendations on advancing health equity and synthesised these into 82 distinct recommendations across five levels of initiative and 19 areas of initiative. Thereby, 24% of the included studies explicitly mentioned the use of (digital) technology with 10 impact opportunities on advancing health equity.
Conclusion
Our synthesis offers key insights into the advancement of health equity across different levels of initiative and the role of DHTs in their implementation. This offers practitioners and researchers alike a comprehensive overview to make health equity advancement more tangible and actionable.
Registration details
https://osf.io/94pht
Wearable sensing in eating episode monitoring: an updated systematic review protocol
Introduction
Objective and accurate dietary monitoring is critical for comprehensive dietary assessment and improving nutritional health outcomes. The rapid advancement of wearable sensing technology presents a promising solution for effective dietary monitoring by reducing recall bias and enhancing user convenience, with potential benefits for both clinical chronic disease management and nutritional research. This systematic review aims to evaluate the effectiveness and feasibility of wearable sensors in monitoring dietary behaviours, while also examining the latest advancements in the field since 2020.
Methods and analysis
This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guidelines for systematic review reporting. We will conduct a comprehensive search across MEDLINE, EMBASE, PubMed, IEEE Xplore and Web of Science to identify studies published between January 2020 and March 2025 involving human participants using wearable sensors for dietary intake monitoring. Studies that focus solely on the development of algorithms or applications for these sensors will be excluded. The outcomes of this review will include evaluations of sensor design, performance metrics and user experience.
Ethics and dissemination
Findings of this systematic review will be disseminated through peer-reviewed journals, conferences and seminar presentations. The data used do not include individual patient data, so no ethical approval is required.
Striving to integrate self-management into daily life: a qualitative meta-synthesis of the perspectives and experiences from head and neck cancer survivors
Background
Head and neck cancer (HNC) represents a prevalent category of malignant tumours, with disease-associated and treatment-associated symptoms often resulting in significant complications that adversely impact patient quality of life. Effective self-management during treatment and rehabilitation is crucial for mitigating or delaying the onset of these symptoms. While existing studies have investigated various aspects of self-management, including its content, influencing factors and specific strategies for managing symptom burden in HNC survivors, no comprehensive study of the self-management experience in this patient population has hitherto been conducted.
Objective
This study aimed to systematically synthesise evidence on the content, experiences, barriers and facilitators of self-management among patients with HNC, with the ultimate goal of informing tailored self-management interventions.
Design
A systematic review of qualitative studies was conducted using a meta-aggregation approach.
Methods
A three-step search strategy was implemented to systematically review eight databases, including PubMed, Web of Science, CINAHL and Embase, from inception to June 2024. This review concentrated on studies examining the content of self-management for patients with HNC during treatment and rehabilitation, identifying both facilitators and barriers and delineating empirical self-management strategies. Two researchers independently screened the literature and performed quality assessments using the Joanna Briggs Institute qualitative research evaluation tool. Subsequently, data extraction was conducted to collect pertinent information. This qualitative systematic review adheres to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and the Enhancing Transparency in Reporting the Synthesis of Qualitative Research statement.
Results
A total of 3263 studies were identified, of which 15 met the inclusion criteria and were subsequently incorporated into the meta-synthesis. This integration revealed 3 primary themes and 10 subthemes, specifically: (1) the management of disease-related and treatment-related symptoms and functional alterations in HNC, exploring self-management strategies such as coping with and monitoring physical and mental symptoms and adjusting to modifications in fundamental operations; (2) barriers and facilitators in the integration process of self-management, including psychological, emotional and cognitive disorders, the impact of symptom burden on patients’ motivation and capacity for self-management, structural impediments and facilitators; and (3) challenges in incorporating self-management into daily life and strategies for effective implementation, encompassing acceptance and adaptation as strategies for coping and thriving, proactive issue resolution, self-motivation and the employment of a diverse array of targeted strategies emphasising recovery.
Conclusions
Patients diagnosed with HNC must engage in extensive self-management throughout diagnosis and treatment, encountering numerous challenges when integrating self-management practices into their daily lives. Despite the numerous challenges encountered, patients with HNC continue to endeavour to incorporate self-management strategies into their daily routines. Future research could leverage these insights to further investigate and delineate the essential elements and effective components of self-management and design targeted self-management interventions tailored for this patient population.
PROSPERO registration number
CRD42022365704.
Effectiveness of education and training programmes to help clinicians assess and classify perineal tears: a systematic review
Objective
For every 100 women having a vaginal birth, approximately four will experience a severe (third-degree or fourth-degree) perineal tear. Severe perineal tears are associated with significant short-term and long-term consequences if not recognised and repaired. There are global efforts to reduce incidence of severe perineal tears including initiatives to strengthen education and training of clinicians in perineal anatomy and perineal tear assessment and classification. This systematic review aimed to describe and evaluate the effectiveness of these initiatives.
Design
Systematic review, reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
Data sources
Medline (Ovid), CINAHL Complete (EBSCO), MIDIRS and EMBASE (Ovid) were searched through 15 February 2024.
Eligibility criteria
Studies reporting simple or complex interventions aimed at improving the skills and knowledge of clinicians in perineal anatomy and/or the clinical assessment and classification of perineal tears were eligible.
Data extraction and synthesis
Two reviewers independently screened studies for eligibility and appraised the quality of individual studies using the Cochrane Risk of Bias (RoB) 2.0 tool or Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tool.
Results
In total, 7645 citations were screened and 39 studies included. We identified nine unique interventions including training programmes, short workshops and senior obstetrician supervision. Many studies were from high-income countries, in primary care settings and at high risk of bias.
Conclusions
Effective education included practical components, such as hands-on skills and training in perineal anatomy, assessment and classification, rather than senior supervision alone. Ongoing review of practice appears to be crucial for maintaining knowledge and skills. Future research should focus on interventions tailored to limited-resource settings, and the optimal length and intensity of training programmes to assess and classify perineal tears.
PROSPERO registration number
CRD42020185431.
Machine learning methods, applications and economic analysis to predict heart failure hospitalisation risk: a scoping review
Background
Machine Learning (ML) has been transformative in healthcare, enabling more precise diagnostics, personalised treatment regimens and enhanced patient care. In cardiology, ML plays a crucial role in risk prediction and patient stratification, particularly for heart failure (HF), a condition affecting over 64 million people globally and imposing an economic burden of approximately $108 billion annually. ML applications in HF include predictive analytics for risk assessment, identifying patient subgroups with varying prognoses and optimising treatment pathways. By accurately predicting the likelihood of hospitalisation and rehospitalisation, ML tools help tailor interventions, reduce hospital visits, improve patient outcomes and lower healthcare costs.
Objective
To conduct a comprehensive review of existing ML models designed to predict hospitalisation risk in individuals with HF.
Methods
A database search including PubMed, SCOPUS and Web of Science was conducted on 31 March 2024. Studies were selected based on inclusion criteria focusing on ML models predicting hospitalisation risks in adults with HF. The data from 27 studies meeting the criteria were extracted and analysed, with a focus on the predictive performance of the ML models and the presence of economic analysis.
Results
Most studies focused on predicting readmission rather than first-time hospitalisation. All included studies employed supervised ML algorithms, with ensemble-based methods generally yielding the highest predictive performance. For 30-day hospitalisation or readmission risk, Extreme Gradient Boosting (XGBoost) achieved the highest mean area under the curve (AUC) (0.69), followed by Naïve Bayes (0.68) and Deep Unified Networks (0.66). For 90-day risk, the best-performing models were Least Absolute Shrinkage and Selection Operator and Gradient Boosting, both with a mean AUC of 0.75, followed by Random Forest (0.67). When the prediction timeframe was unspecified, Categorical Boosting achieved the highest performance with a mean AUC of 0.88, followed by Generalised Linear Model Net and XGBoost (both 0.79).
Electronic health records were the primary data source across studies; however, few models included patient-reported outcomes or socioeconomic variables.
None of the studies conducted an economic evaluation to assess the cost-effectiveness of these models.
Conclusions
ML holds substantial potential for improving HF care. However, further efforts are needed to enhance the generalisation of models, integrate diverse data sources and evaluate the cost-effectiveness of these technologies.
Realist evaluation of Belgian pilot projects for paediatric transmural care: protocol for a mixed methods study
Introduction
The Belgian healthcare system is to a large extent hospital-centred, prompting government initiatives to shift care towards patient’s homes and reduce hospital stays. To avoid unnecessary hospital stays and offer alternative and innovative forms of care, the Belgian federal health authorities selected five pilot projects for transmural care for chronically ill children. Guided by the Medical Research Council framework, this study aims to evaluate the paediatric transmural care projects to inform new models for paediatric care.
Methods and analysis
Using a mixed-methods realist evaluation, the study comprises three phases: (1) initial programme theory development, (2) initial programme theory testing and (3) programme theory refinement. In a first phase, the initial programme theory rooted in the normalisation process theory will be refined from insights retrieved from document review and focus group interviews with healthcare professionals. In the second phase, the initial programme theory will be tested using empirical data. Routine data and questionnaires will examine whether characteristics of participants and outcomes are in line with the quintuple aim framework. Focus groups with children, parents and stakeholders, and document analysis will be used to evaluate the structure of the intervention, examine the process and context, and understand more in-depth the outcomes. A budget impact analysis will be used to assess whether the pilot project is affordable. In a third phase, qualitative and quantitative data will be analysed using a convergent mixed-methods model, involving continuous triangulation of multiple data sets to facilitate greater understanding of the context and refinement of the programme theory.
Ethics and dissemination
The study protocol was reviewed and approved by the Ethics Committee of the Ghent University Hospital (Belgian Registration Number B6702024000193) after consultation with all Ethics Committees of the participating hospitals. Written informed consent will be obtained from participants or their legal representatives prior to data collection. Participant confidentiality will be maintained throughout the study. Study results will be published in international peer-reviewed journals and will be presented at national and international conferences. The general population will be informed of the aggregated results.
Trial registration number
ClinicalTrials.gov, NCT06679595.
Development and validation of critical appraisal tool for individual participant data meta-analysis: protocol for a modified e-Delphi study
Introduction
Individual participant data meta-analysis (IPD-MA) is regarded as the gold standard for evidence synthesis. However, diverse recommendations and guidance on its conduct exist, and there is no consensus-based tool for the critical appraisal of a completed IPD-MA. We aim to close this gap by systematically identifying quality items and developing and validating a critical appraisal checklist for IPD-MA.
Methods and analysis
This study will comprise three phases, as follows:
Phase 1: a systematic methodology review to identify potential checklist domains and items; this will be conducted according to the Cochrane methods for systematic reviews and reported following the Preferred Reporting Items for Systematic Reviews and Meta-analysis 2020 guidance. We will include studies that address methodological guides and essential statistical requirements for IPD-MA. We will use the proposed items to prepare a preliminary checklist for the e-Delphi study.
Phase 2: at least two rounds of an e-Delphi survey will be conducted among panels with expertise in IPD-MA research, consensus development, healthcare providers, journal editors, healthcare policymakers, patients and public partners from diverse geographic locations with experience in IPD-MA. Participants will use Qualtrics software to rate items on a 5-point Likert scale. The Wilcoxon matched signed rank test will estimate response stability across rounds. Consensus on including an item will be achieved if ≥75% of the panel rates the item as ‘strongly agree’ or ‘agree’ and items will be excluded if ≥75% rates it as ‘strongly disagree’ or ‘disagree’. A convenience sample of 10 reviewers with experience in conducting an IPD-MA will pilot-test the checklist to provide practical feedback that will be used to refine the checklist.
Phase 3: critical appraisal checklist validation: to improve confidence in the tool’s uptake, a subset of the e-Delphi participants and graduate students of epidemiology and biostatistics will conduct content validity and reliability testing, respectively, per the Consensus-based Standards for the Selection of Health Measurement Instruments.
Ethics and dissemination
Ethics approval has been obtained from the Western University Health Science Research Ethics Board in Canada. The validated checklist will be published in a peer-reviewed open-access journal and shared across the networks of this study’s steering committee, Cochrane IPD-MA group and the institutions’ social media platforms.
Exploring evidence gaps in clinical trials in thermal burns care: an umbrella review
Background
Gaps in research evidence lead to research waste. In burns treatment, there is a paucity of reliable evidence or data. This contributes to inconsistent patient care, especially on a global scale, where low-resource countries often lack access to the latest research advancements. This umbrella review was undertaken as part of the James Lind Alliance Priorities in Global Burns Research Prioritisation Setting Partnership (PSP) and aimed to identify and assess the quality of evidence in thermal burns care. The objective was to map which interventions in thermal burns care are supported by a reliable evidence base and for which the evidence is lacking.
Methods
Systematic reviews of randomised controlled trials in thermal burns were identified and assessed using reliability criteria determined a priori. Multiple systematic review databases were searched in June 2023, including the Cochrane Library, KSR Evidence database and NIHR Journals Library. Summary of findings and, where available, Grading of Recommendations Assessment, Development and Evaluation was used to assess certainty of evidence. Reliable reviews were mapped onto clinical categories identified by patients, carers and healthcare professionals as part of the PSP.
Results
232 systematic reviews were identified, of which 83 met reliability criteria and were included. The main reason for not meeting reliability criteria was poorly defined eligibility criteria (n=128). Of the 83 reliable reviews, most were conducted in pain (n=28) or wound management (n=14) and acute care (n=13). Certainty of evidence was mixed. Reviews mapped onto nine of the 17 clinical categories identified by the PSP.
Conclusion
This review summarises the available high-quality evidence in burns care and identifies evidence gaps, indicating that many important clinical questions remain unanswered. There is a discrepancy between the treatments investigated in high-quality research and the clinical areas considered as most important to stakeholders. These findings provide direction for future research to improve global burns care.
Comparing non-ischaemic heart preservation (NIHP) with ischaemic static cold storage of donor hearts in adult cardiac transplantation: study protocol for a randomised controlled trial
Introduction
Ischaemia–reperfusion (I/R) injury remains a major challenge in heart transplantation, with mortality risk increasing significantly when allograft ischaemic time exceeds 4 hours. Non-ischaemic heart preservation (NIHP), using continuous hypothermic perfusion, has shown promise in preliminary studies for reducing I/R injury and improving outcomes. This randomised controlled trial aims to compare NIHP with standard static cold storage (SCS) in adult heart transplantation.
Methods and analysis
The trial is a prospective, open-label, multicentre, single-blinded, randomised controlled trial including 66 adult heart transplant recipients across four Swedish hospitals. Participants will be randomised into 1:1 ratio to NIHP or SCS preservation groups and undergo a 12-month follow-up period. The primary outcome is 1-year survival free from acute cellular rejection or retransplantation. Secondary outcomes include quality of life, I/R injury markers, graft function and adverse events. Substudies will evaluate renal function using MRI and continuously monitor physical activity and heart rhythm via wearable devices. Analysis will follow intention-to-treat principles, with time-to-event analysis using Cox proportional hazard models and Kaplan-Meier estimates.
Ethics and dissemination
The study has been approved by the Swedish Ethical Review Authority. It will be conducted according to the Declaration of Helsinki and relevant local and international regulations. Results will be published in peer-reviewed journals following Consolidated Standards of Reporting Trials guidelines.
Trial registration number
NCT04066127.