Dementia is a global public health concern, with prevalence projected to reach 78 million individuals by 2030 and 139 million by 2050. Most persons living with dementia reside in community settings and are supported by family caregivers. As caregiving demands grow, caregivers experience significant psychosocial, emotional, and financial burden, including high rates of stress, social isolation, and depressive symptoms. Access to effective support services remains limited, highlighting the urgent need for innovative and accessible caregiver interventions. This pilot study first aims to assess the feasibility, acceptability, and tolerability of VR-SIM Carers, a virtual reality (VR)-based psychoeducational training program for family caregivers or care partners of people living with dementia. Second, it will aim to provide a preliminary evaluation of potential impact on caregiver outcomes, including caregiver competence, stress, resilience, empathy, and quality of life. The study is not designed to support causal inference regarding the effectiveness of VR-SIM Carers. A mixed methods design will be used with a sample of 30 family caregivers of people living with dementia. Participants will complete 3 immersive, self-paced VR caregiving scenarios-Managing Apathy, Crisis Response, and Refusal of Care-receiving real-time feedback from simulated characters, including clinician and person living with dementia avatars. Primary outcomes (feasibility and educational impact) include recruitment, retention, adherence, usability, acceptability, and tolerability and caregiver competence (Pearlin Caregiving Competence Scale), perceived stress (Cohen Perceived Stress Scale), resilience (Connor-Davidson Resilience Scale), and empathy (Empathy Assessment Scale). Secondary outcomes (preliminary efficacy) include caregiver quality of life (Adult Carer Quality of Life Questionnaire), caregiver burden (Burden Questionnaire), and behavioral symptoms (Neuropsychiatric Inventory, Center for Epidemiologic Studies Depression Scale Short Form) assessed at baseline, postintervention, and 1-month follow-up. Feasibility and user engagement will be evaluated via the 18-item Gaming Use Engagement and Severity Scale, Igroup Presence Questionnaire, qualitative interviews, reflection notes, and open-ended feedback. Quantitative data will be analyzed using repeated-measures ANOVA and paired 2-tailed t tests, while qualitative data will be analyzed using an inductive thematic coding framework. Data analyses are descriptive and exploratory only, and no causal claims regarding intervention effectiveness will be made. Consistent with CONSORT (Consolidated Standards of Reporting Trials) guidance for pilot and feasibility studies, caregiver outcomes (eg, competence, stress, resilience, empathy) are treated as exploratory. The findings from this study will inform the feasibility, acceptability, and educational value of immersive VR for caregiver training, while providing preliminary evidence regarding the efficacy of VR-SIM Carers as a training tool to improve psychoeducation outcomes for family caregivers of people living with dementia and reduce caregiving burden. Data collection commenced in March 2024 with a projected end date of March 2026. As of the submission of the manuscript (December 2025), 21 participants have been enrolled. Data analysis will be completed in April 2026, and the results are expected to be published in fall 2026. VR-SIM Carers represents an innovative, scalable intervention designed to enhance caregiver preparedness, psychosocial outcomes, and sustainable community-based dementia care. This pilot study will provide critical evidence to guide further development and implementation of VR-based caregiver support programs.

Aim: To analyze the quality of abstracts of the randomized controlled clinical trials on Curcuma longa L.Methods: We queried MEDLINE via PubMed for abstracts of randomized controlled trials on Curcuma longa L. and evaluated their reporting quality according to the criteria from the CONsolidated Standards Of Reporting Trials (CONSORT) statement. The collected data were analyzed using the χ2 statistical test to examine a correlation between the presence of CONSORT checklist items and the structure of the abstract.Results: The search retrieved 170 scientific articles, of which 138 met our inclusion criteria. The median total score of the abstracts was 7, with most scores ranging between 6 and 9. We found significant differences regarding the presence of CONSORT items depending on the abstract structure: objective and primary outcomes appeared the most frequently, while source of funding and randomization process appeared the least frequently.Conclusion: According to CONSORT criteria, abstracts of randomized controlled trials on Curcuma longa L. exhibit suboptimal quality. Most worryingly, there is a lack of information on funding sources and randomization processes in most of the abstracts, significantly impacting the transparency and trustworthiness of the clinical trials.

The Effect of a Virtual Reality Distraction Intervention on Pain in Patients Following a Percutaneous Coronary Intervention: A Randomized Clinical Trial.

The treatment evidence base for gaming disorder (GD) has grown steadily over the past two decades. A systematic review by King et al. (2017) of 30 studies reported that GD treatment studies tended to favor psychotherapy approaches, but the research was limited by poor reporting standards as assessed by the Consolidated Standards of Reporting Trials (CONSORT) framework. This systematic review aimed to conduct a follow up evaluation of the reporting quality of subsequent GD treatment studies. A literature search of six databases yielded 51,056 records, which resulted in 31 eligible studies after screening. Each study's reporting quality was assessed using the CONSORT statement, and then these assessments were compared to King et al.'s (2017) review. This review identified several methodological improvements since 2017: 61% of studies were randomized controlled trials (vs. 40% in 2017), 90% included control groups (vs. 63%), and follow-up duration increased to 6.1months (vs. 3.5months; p=.032). Reporting improved for participant flow (87.1% vs. 43.3%; p=.001) and group-level statistics (74.2% vs. 36.7%; p=.003), but some areas showed no improvement. There have been several improvements in GD treatment study design and reporting, including controls, randomization and follow up, reflecting an increasing number of higher quality trials for the condition. Most of the studies with higher reporting quality (i.e., scoring ≥30/46 on the CONSORT framework) were psychotherapy-based. Future research should employ designs with longer follow-ups, broader assessment of outcomes, and standardized ICD-11-aligned tools. Pharmacological treatments, including novel pharmacotherapies for other addictions (e.g., Naltrexone), are underexplored and lack high quality evidence.

The Impact of e-Mobile Education Based on the Life Model on Anxiety and Daily Living Activities in Thyroidectomy Patients: A Randomized Controlled Trial.

Cluster randomized trials (CRTs) reduce intervention contamination but may compromise statistical efficiency. Although Consolidated Standards of Reporting Trials (CONSORT) guidelines recommend reporting intraclass correlation coefficients (ICCs), compliance is limited. This meta-analysis attempts to estimate the pooled ICC of CRTs on anxiety disorders. A systematic search in various databases yielded 1,124 citations, qualifying 23 studies for meta-analysis upon further screening. DerSimonian and Laird's inverse variance method was used to calculate the pooled estimates. Among 23 studies, 16 reported ICCs at the design stage, with no significant difference compared to post-intervention values. The pooled ICC was 0.05 (95% CI: 0.04-0.06) with substantial heterogeneity; funnel plot asymmetry suggested publication bias, though Egger's test found no small-study effects (P = 0.913). Only two-thirds of CRTs on anxiety disorders complied with CONSORT recommendations on ICC reporting. The pooled ICC from this meta-analysis provides a reference for sample size estimations in future CRTs targeting anxiety disorders.

Spin refers to reporting strategies that highlight the benefits of an experimental treatment or divert attention from nonsignificant primary outcomes. To assess spin in randomized clinic trials (RCTs) on pharmaceutical efficacy in multiple sclerosis (MS) and explore associated factors. A systematic literature search was conducted in MedLine (PubMed), EMBASE, and Cochrane using database-specific thesauri ("Multiple Sclerosis" and "Drug Therapy") to identify relevant studies. We included multiple sclerosis phase 3 and 4 randomized controlled trials with parallel, superiority designs that were published between 2013 and 2024 reporting nonsignificant primary outcomes. Spin was assessed in title, abstract conclusion, results, discussion, and conclusions. A descriptive analysis was followed by exploratory bivariate logistic regression. Independent variables included trial phase, sample size, drug type, comparison, follow-up time, registration, Consolidated Standards of Reporting Trials (CONSORT) mention, risk of bias (RoB2), journal quartile, first author affiliation, and conflict of interest. Forty articles met inclusion criteria. Spin appeared in at least one section in 25 articles (62.5%) and in 3 or more in 19 articles (47.5%). The most frequent locations were abstract conclusions, discussion, and conclusions. Spin was significantly associated with smaller sample size (odds ratio [OR] = 7.00, 95% confidence interval [CI] = 1.29-37.91, p = 0.024), non-Q1 journals (OR = 4.38, 95% CI = 1.03-18.63, p = 0.046), and first author affiliation outside Europe or the United States (OR = 5.09, 95% CI = 1.15-22.62, p = 0.032). Spin is common in MS randomized controlled trials with nonsignificant primary outcomes and may mislead clinical decisions. ANN NEUROL 2026;99:316-327.

BackgroundRadiodermatitis is a common skin injury in patients undergoing radiotherapy, especially in cases of head and neck cancer, and may impair treatment adherence and the patient’s quality of life. Therefore, the search for effective and low-cost interventions for the prevention and management of radiodermatitis is essential. In this context, Calendula- and Chamomile-based creams have been considered in oncological care.ObjectiveTo evaluate the effectiveness of topical Calendula and Chamomile creams in the prevention and treatment of radiodermatitis in head and neck cancer patients undergoing radiotherapy combined with chemotherapy.MethodsThis is a protocol for a randomized, controlled, triple-blind clinical trial employing a quantitative approach. The protocol adheres to the guidelines advocated by the Consolidated Standards of Reporting Trials (CONSORT) 2025 and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025. A total of 99 participants will be randomly allocated into 3 groups. Data will be collected using a four-section instrument and analyzed with Microsoft Office Excel and Statistical Package for Social Sciences (SPSS) version 20.0.ResultsThis study aims to validate the effectiveness of Calendula and Chamomile creams in controlling radiodermatitis and to identify the most efficient option for preventing adverse effects.ConclusionThe findings are expected to underscore the necessity of promoting and implementing systematic, scientifically grounded protocols in oncological patient care, emphasizing a humanized approach.Trial and Protocol RegistrationBrazilian Registry of Clinical Trials (ReBEC), RBR-8gxt823, https://ensaiosclinicos.gov.br/rg/RBR-8gxt823.

This systematic review synthesizes empirical research on organizational strategies that support the sustainability and scale-up of community-based interventions designed to promote youth psychological well-being. While research has established the effectiveness of youth mental health interventions in community contexts, less is understood about the processes that ensure their long-term sustainability and scale-up. A search across seven databases yielded 27 eligible empirical studies (2003-2025) including peer-reviewed and grey literature. The Synthesis without Meta-analysis (SWiM) and the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) standards provided a framework for conducting and documenting the review. Evaluations of methodological quality were carried out using Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), Consolidated Standards of Reporting Trials (CONSORT), and the Critical Appraisal Skills Programme (CASP). Two dominant strategies for intervention retention and effectiveness were identified: training and technical assistance (12 studies, 44%) and capacity building with implementation support (12 studies, 44%). The main barriers to sustainability and scale-up were reported as staffing as well as other resource limitations (financial, human, and technical), while facilitators included strong communication and leadership, sufficient funding and partnerships, and access to training and technology. Eleven studies (41%) sustained interventions beyond the initial funding period, with key factors including intervention fidelity, agency incentives, organizational support, therapist retention, and stakeholder engagement. The findings highlight the potential benefits of embedding sustainability and scale-up strategies in the pre-implementation phase, anticipating foreseeable barriers, and considering intervention fidelity, workforce stability, and organizational readiness as important precursors to sustainability and scale-up.

Although several randomized controlled trials (RCTs) have examined the efficacy of rotavirus vaccines, few have comprehensively assessed their reporting quality and risk of bias. This study aimed to evaluate the reporting quality and methodological rigor of RCTs on rotavirus vaccines using the CONsolidated Standards Of Reporting Trials (CONSORT) 2010 checklist and the Cochrane Risk of Bias 2.0 (RoB 2.0) tool. We systematically searched PubMed and Cochrane Central for phase 3 randomized controlled trials of rotavirus vaccines administered as monotherapy. Reporting quality was assessed using the CONSORT 2010 checklist and risk of bias was evaluated with the Cochrane RoB 2.0 tool across five domains to determine overall methodological rigor. A total of 29 phase 3 RCTs were included after screening 1,066 records. Most trials were conducted in Asia and funded by industry. Adherence to the CONSORT 2010 checklist was high for trial design and outcome reporting but poor for protocol availability, allocation concealment, and blinding procedures. Overall, 62% of studies had a low risk of bias, while 34% were rated high. Trials published after 2010 and those with low risk of bias showed significantly higher reporting quality. Adherence to the CONSORT 2025 guidelines is essential for future rotavirus vaccine trials, enhancing the quality of individual studies while reinforcing the broader evidence base that informs immunization strategies and public health policies.

Research in hyperbaric oxygen (HBO) medicine is growing, but the quality of HBO studies is variable. Low study quality may compromise evidence-based decision-making and clinical translation. This cross-sectional study examined the adherence of 50 randomly selected HBO clinical trials (25 randomised controlled trials [RCTs] and 25 observational studies) to relevant core reporting guidelines: consolidated standards of reporting trials (CONSORT), non-pharmacologic treatments (NPT), and strengthening the reporting of observational studies in epidemiology (STROBE). Studies published in peer-reviewed journals between January 2018 and May 2023 and indexed on PubMed were analysed. Reporting quality was classified as 'excellent' (> 85% of guideline items adequately reported), 'good' (50-85%), or 'poor' (< 50%). The sample represented 29% of RCTs and 16% of observational studies for the timeframe assessed. No study was rated as 'excellent' for completeness, 28 (56%) were rated as 'good', and 22 (44%) as 'poor'. In RCTs, only one study (4%) adequately reported protocol adherence and eight studies (32%) reported blinding procedures. The NPT checklist showed that key items, including care provider adherence (0 studies) and participant adherence (one study; 4%), were frequently not reported. For observational studies, basic design elements were adequately reported, but with significant gaps in bias management (nine studies; 36%) and missing data handling (13 studies; 52%). Only six studies (12%) mentioned the use of reporting guidelines. Our results showed that quality of reporting of HBO studies is suboptimal. These findings highlight the need for increased awareness and implementation of reporting guidelines, as well as the potential development of HBO-specific guidelines.

Black cohosh (BC) is a herbal medicine being prescribed for the management of climacteric complaints. This is the first review to assess the quality of evidence for BC as measured by adherence to Consolidated Standards of Reporting Trials (CONSORT) extensions for herbal interventions and harms. Herbal medicines such as Actaea racemosa (A. racemosa; synonym Cimicifuga racemosa, BC) are commonly being used by women seeking relief from menopausal (climacteric) complaints. Our objective is to evaluate the quality of reporting of clinical trials investigating A. racemosa for climacteric complaints, by grading their adherence to both the CONSORT extensions for herbal interventions, and for reporting adverse events (harms). A systematic search of the databases: AMED, CINAHL, EBSCO, Academic Search Ultimate, Google Scholar, PubMed and Science Direct, was conducted in April 2023 and another search done March 2024. The search phrase employed included relevant herbal or herbal product keywords ["black cohosh," "actaea racemosa," "cimicifuga racemosa," "BNO 1055," "remifemin," "Ze 450"] combined using the Boolean operator term AND with keywords regarding climacteric complaints ["menopausal symptoms," "menopause," "climacteric complaints"]. Additional citation searching was conducted to identify any other published studies. Articles were included if they were clinical trials of oral use of A. racemosa in humans. Quality assessment of included articles was undertaken to review adherence to the CONSORT Statement Extensions for reporting on herbal interventions, and harms (adverse events). Fourteen records were included in the final analysis. Adherence to the herbal extension for the CONSORT ranged between 39% and 87%, with four of them receiving an adherence rating of 50% or less. Adherence to the Harms Extension for the CONSORT ranged between 6% and 90%, with three of the articles receiving an adherence rating of 50% or less. This is the first time a systematic review of the quality of clinical trial reports of BC, using the CONSORT herbal extension and harms checklists, has been conducted. The wide range of ratings found in our quality assessment suggests the need for further high-quality investigation of this widely used herbal preparation.

Over three decades, randomized controlled trials (RCTs) for critical care syndromes such as acute respiratory distress syndrome (ARDS), sepsis, and community acquired pneumonia (CAP) have repeatedly produced non-reproducible results, at times leading to high-impact reversals of global protocols when later studies revealed harm. These trials enroll patients using expert-derived threshold sets intended to define the syndrome. This analytic review presents the first historical and formal methodological review and mathematical analysis of such RCT using causal symbolic modeling (cSM), directed acyclic graphs (DAGs), and do-calculus. The review includes landmark publications, task-force threshold sets, and case examples, including the 2025 REMAP-CAP corticosteroid domain, to model the causal structure of standard RCTs applied to threshold-defined syndromes. PubMed searches and ChatGPT were used to assist in this process. The historical inquiry uncovered that the critical care syndromes of ARDS and sepsis are guessed synthetic constructs, devised in the twentieth century by Thomas Petty and Roger Bone as heuristic groupings of diverse but similar appearing diseases. However a much more striking discovery was that Petty and Bone introduced a streamlined variant of the Bradford Hill RCT method, here termed the "Petty-Bone RCT', which conditions enrollment on a triage threshold set that functions as a cohort-level collider. This design yields results valid only for the unstable mixture of diseases enrolled. The "Petty-Bone RCT" preserves the outward form of a randomized trial but lacks the causal structure needed for transportability, making it an RCT mimic. The cSM analysis in this review shows that while potentially internally valid, such trials cannot produce reliable treatment protocols and often cause harm. These findings compel the abandonment of the Petty-Bone RCT framework, the integration of cSM into the Consolidated Standards of Reporting Trials (CONSORT), and prioritizing mechanistically grounded, investigator-led designs in critical care research. These provocative discoveries indicate that not one more patient, not one more investigator, not one more grant should be sacrificed to the next iteration of a Petty and Bone's synthetic syndrome RCT.

BackgroundPodcasts have emerged as a popular medium in medical education over the past decade. Audio learning allows flexibility and may help residents engage with content in new ways. Reading scientific literature is a core skill for residents, yet many residents struggle to comprehend complex research articles. Advances in artificial intelligence (AI) have enabled the automatic generation of podcast-style summaries of documents. It remains unclear whether listening to AI-generated podcast summaries can match the educational value of reading the full text of medical papers, and whether this depends on the complexity of the article.ObjectiveThis study aims to compare comprehension of medical research papers when learning via an AI-generated audio podcast versus traditional reading. We will examine whether article complexity (narrative vs technical) moderates any difference. We hypothesize an interaction: for a highly complex article, residents who read the full text should achieve a better understanding than those who listen to a summary, whereas for an easier article, the difference between modalities should be smaller.MethodsWe designed a 2×2 mixed factorial study with 60 resident physicians preparing for the board certification in internal medicine or cardiology. All participants will engage with 2 peer-reviewed cardiology articles differing in complexity: a narrative case report on eosinophilic myocarditis and a technical research article on quantifying the vena contracta area using 3-dimensional echocardiography. Each participant will read 1 article and listen to an AI-generated podcast summary of the other, with the order and assignment counterbalanced to control for order effects. The podcasts are created using Google NotebookLM’s experimental audio overview feature. Participants will complete a multiple-choice knowledge test for each article. The primary outcomes are comprehension scores for each modality. The secondary outcomes include intrinsic motivation, perceived learning gains, and cognitive load for each condition. Data will be analyzed using a mixed ANOVA to test the main effects of modality and article complexity, as well as their interaction.ResultsData collection is expected to be completed by early 2026. We will report the trial results according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines, and any deviations from this protocol will be documented and justified. No results are available at the time of publication of this protocol.ConclusionsThis randomized trial will offer evidence on the effectiveness of AI-generated podcast summaries as a learning tool for medical literature. If listening to an AI-generated podcast yields comprehension comparable to or superior to reading the full article, it could validate an innovative, time-saving approach for busy medical trainees. Conversely, if significant deficits are observed in the podcast group (especially for complex content), the findings will highlight the limitations of AI summaries and the continued importance of traditional reading for thorough understanding.International Registered Report Identifier (IRRID)PRR1-10.2196/78505

This evidence mapping (EM) and quality assessment of randomized controlled trials (RCTs) in Dental Traumatology (DT) aimed to identify the RCTs, distribute them in different domains and subdomains, analyze their methodological characteristics, and assess their quality. A protocol was developed as per the principles of Global-Evidence-Mapping (EM) and registered in open-sciences-framework. A systematic electronic search was performed in the PubMed, SCOPUS, EMBASE, Web of Science, LILACS, and COCHRANE on September 30, 2025. Grey literature and reference searches were also performed. RCTs with intervention arms with/without a control group, having details of randomization related to any domain of DT, were included after screening of titles, abstracts, and full-text articles. Studies were distributed in domains and subdomains, and data related to demographic and methodological characteristics were extracted and analyzed. Risk of bias (ROB) was assessed using the Cochrane risk-of-bias tool for randomized trials (RoB-2) and details were presented in the form of an abacus EM plot. The study identified 30 RCTs in four domains of DT, with the highest in the therapeutic domain and subdomain of treatment protocols in permanent dentition. Seven studies were published before 2010, nine between 2010 and 2019, and 14 others from 2020 to date. They represented 13 countries, with the highest from China, the United Kingdom, and India. A protocol was registered in 10 studies, and the majority of the studies had not followed Consolidated Standards of Reporting Trials (CONSORT) guidelines. Only three RCTs were found to have a low ROB. The majority of studies exhibited a lack of methodological robustness in defining their hypothesis, sample size estimation, randomization, and statistical evaluation of outcomes. This was the reason for 27 of them being graded as having high ROB or some concerns. The results of this EM may help researchers in identifying the areas for future research and guide them to follow the best practices in the planning and conduct of RCTs.

Purpose: This study aims to evaluate the reporting completeness of randomized controlled trials (RCTs) published in the Journal of Korean Biological Nursing Science (JKBNS) from 2011 to 2024 using the updated Consolidated Standards of Reporting Trials (CONSORT) 2025 guidelines. Methods: A systematic search of the JKBNS archive was conducted using keywords related to random allocation. A total of 22 RCTs were identified and included in this methodological review. Eligible studies were defined as RCTs involving human participants. Reporting completeness was assessed using the CONSORT 2025 checklist. In addition, a conceptual mapping analysis was performed to examine the alignment between CONSORT 2025 checklist items and methodological quality domains derived from the Risk of Bias 2.0 (RoB 2.0), the Scottish Intercollegiate Guidelines Network (SIGN), and the Joanna Briggs Institute (JBI) critical appraisal tools. Results: Of the 22 reviewed RCTs, 19 used a parallel-group design and 3 employed a crossover design. Most studies evaluated non-pharmacological interventions, most commonly aromatherapy. The mean CONSORT 2025 compliance score was 24.77 ± 3.15, with 18 items consistently reported across studies. However, critical elements such as protocol amendments, interim analyses, and approaches to handling missing data were rarely addressed. Evaluation of 42 detailed items corresponding to 30 checklist numbers showed an overall average reporting rate of 59.0%. Fourteen CONSORT 2025 checklist items demonstrated conceptual alignment with domains from RoB 2.0, SIGN, and JBI. Conclusion: The overall reporting quality of RCTs published in JKBNS was moderate. Future RCT submissions to nursing journals should emphasize rigorous and comprehensive adherence to reporting standards such as the CONSORT 2025 checklist to improve methodological transparency and reproducibility.

ABSTRACTBackgroundAlthough clinical trials are fundamental to advancing evidence‐based practice, significant heterogeneity in outcome reporting poses a considerable challenge to the validity of systematic reviews. This inconsistency impedes the ability to compare, synthesise and interpret research findings effectively. In the field of paediatric airway management, this issue is particularly relevant because of the low incidence of critical events and the related high morbidity and mortality. The issue of inadequate and variable outcome reporting in clinical trials has been widely acknowledged, necessitating initiatives to enhance the quality of future research.ObjectiveThis protocol delineates the methodology used for the development of standardised, consensus‐based outcome definitions and reporting items specifically tailored to paediatric airway management trials. The goal is to create guidance that will serve as an extension to the established SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) frameworks, leading to enhanced trial reproducibility and transparency and ultimately improve pediatric airway research, systematic reviews and advance patient care and safety.MethodsThis project will adhere to the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network's framework for guideline development. The methodology will be structured into four distinct phases: (1) a scoping review to comprehensively identify outcomes and variables currently reported in paediatric airway management trials; (2) a three‐round Delphi process involving a multidisciplinary panel of experts to prioritise and refine outcomes and variables; (3) a consensus meeting to achieve agreement on the final set of reporting items, which will then be prepared for publication and (4) dissemination.ConclusionsThe finalised outcome reporting guidelines, in the form of SPIRIT and CONSORT extensions for paediatric airway management, will be disseminated through various channels to maximise their reach and impact. These include publication in peer‐reviewed journals, presentation at major international conferences and submission to relevant international reporting registries, such as the EQUATOR, SPIRIT and CONSORT registries. Active engagement with key stakeholders, including journal editors, research funders, regulatory bodies and clinician networks and national and international societies, will be a crucial component of the dissemination strategy.

Background and aims: Internet addiction among adolescents has become an increasingly important public health concern worldwide. This study examined the effectiveness of cognitive-behavioral therapy (CBT) in reducing the symptoms and negative consequences of internet addiction in adolescents. Methods: A systematic search was conducted in English, Persian, and other languages for clinical and experimental studies published between 2000 and 2025 on adolescents aged 13–18 years with internet addiction, focusing on CBT-based interventions. Eligible studies compared CBT with control or non-addicted groups and reported outcomes related to reductions in social media addiction. Two independent reviewers screened studies, extracted data, and assessed methodological quality using the Consolidated Standards of Reporting Trials (CONSORT) checklist. Publication bias was evaluated using the Egger test. Primary outcomes were analyzed using a random-effects model in Stata 17 to account for expected heterogeneity. Results: This meta-analysis of nine studies found that CBT significantly reduces internet addiction in adolescents (SMD=1.05, P=0.003), although results varied widely across studies (I²=94.4%). Individual CBT interventions were consistently effective, while group-based interventions demonstrated greater variability and, in some cases, less significance. Experimental studies yielded more reliable positive effects than clinical trials. Secondary outcomes revealed only modest reductions in overall time spent online following group CBT. Meta-regression analyses did not explain the high heterogeneity, indicating that unmeasured factors may influence outcomes. No significant publication bias was detected, supporting the robustness of the findings. Conclusion: CBT effectively reduces internet addiction among adolescents; however, more standardized, high-quality studies are needed to optimize interventions.

ABSTRACTObjectiveTo evaluate the reporting quality of recent randomised controlled trials (RCTs) of acupuncture for low back pain (LBP) and investigate associated factors.Study designA systematic review was conducted to identify and evaluate the reporting quality of RCTs of acupuncture for LBP reported after 2020. The Consolidated Standards of Reporting Trials (CONSORT), STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) and CONSORT-Outcomes statements were used to evaluate the reporting quality of the included studies. Regression analyses were performed on pre-specified study characteristics to explore factors associated with the reporting quality.Data sourcesCochrane Library, PubMed, Web of Science, Embase, China National Knowledge Infrastructure (CNKI), Wan Fang, VIP Database and Chinese Biomedical Literature Database were systematically searched from January 2021 to January 2025.Eligibility criteriaOnly RCTs enrolling patients with LBP diagnosed according to the criteria of the North American Spine Society or other recognised clinical guidelines were included. The eligible interventions comprised manual acupuncture, electroacupuncture and other acupuncture-related therapies. Publication language was restricted to English and Chinese.Data extraction and synthesisLiterature screening, data extraction and reporting quality assessment were independently conducted by two reviewers with professional training. Any discrepancies were resolved by a third reviewer.ResultsFifty-seven RCTs were ultimately included, with a median overall quality score of 32 (range, 17–54). The CONSORT-based median quality score (QS) was 14 (range, 7–31). Among the 37 items comprised in the statement, 11 were sufficiently reported (reporting rate, >80%), whereas 19 were inadequately reported (reporting rate, <30%). Under-reported items were mainly associated with open science and key methodological domains. For the STRICTA reporting standards, the reporting quality of RCTs was satisfactory, with a median QS of 9 (range, 4–13). Only four of the 17 items in STRICTA were under-reported, and the setting and context of treatment had the lowest reporting rate (2/57). The CONSORT-Outcomes-based median QS was 8 (range, 5–16). Among the 17 items, 5 were well reported, and 10 were poorly reported. In addition, RCTs published in English and funded studies had higher reporting quality.ConclusionRCTs of acupuncture for LBP should focus more on reporting open science, key methodology, details of acupuncture and comprehensive outcome-related information. Authors and journals, especially those in China, need to strengthen their adherence to the CONSORT statement and its extensions to enhance the reporting quality of RCTs.

Pediatric randomized controlled trials (RCTs) inform decisions concerning the choice of interventions in children and adolescents. To enable the implementation of effective interventions, RCT reports need to provide adequate details on the elements, infrastructure, and delivery of these interventions. Using the 12-item Template for the Intervention Description and Replication (TIDieR) framework, an international team developed guidance for comprehensive reporting of trial interventions in pediatric RCT protocols and reports. We (1) identified initial pediatric considerations (PCs) and examples of good reporting using 50 recent pediatric RCT reports, (2) held an expert panel meeting, (3) conducted a Family Caregiver Workshop to discuss and get input on PCs, (4) compiled PCs and examples of good reporting, and (5) achieved consensus on final PCs and examples. Thirteen PCs reached consensus; they address how trial intervention materials were appropriate for the age and developmental stage of trial participants, which adjustments to enhance palatability of medications and acceptability of interventions were implemented, and how pediatric-specific dosing was determined. Consensus was also reached on accompanying good reporting exemplars. Presenting a minimum set of considerations pertinent to pediatric trial interventions, the TIDieR-Child & Adolescent Health (TIDieR-C) checklist can help trial authors and evidence end users comprehensively report and appraise tested interventions. It can be used with the pediatric-specific extensions of the Standard Protocol Items for Randomized Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT): SPIRIT-Children & Adolescents and CONSORT-Children & Adolescents. Uptake of this guidance may lead to improved understanding, replicability, and implementation fidelity of effective trial interventions.