OBJECTIVE: This scoping review aims to identify, catalogue, and characterize previously reported tools, techniques, methods, and processes that have been recommended or used by evidence synthesizers to detect fraudulent or erroneous data and mitigate its impact. INTRODUCTION: Decision-making for policy and practice should always be underpinned by the best available evidence-typically peer-reviewed scientific literature. Evidence synthesis literature should be collated and organized using the appropriate evidence synthesis methodology, best exemplified by the role systematic reviews play in evidence-based health care. However, with the rise of "predatory journals," fraudulent or erroneous data may be invading this literature, which may negatively affect evidence syntheses that use this data. This, in turn, may compromise decision-making processes. INCLUSION CRITERIA: This review will include peer-reviewed articles, commentaries, books, and editorials that describe at least 1 tool, technique, method, or process with the explicit purpose of identifying or mitigating the impact of fraudulent or erroneous data for any evidence synthesis, in any topic area. Manuals, handbooks, and guidance from major organizations, universities, and libraries will also be considered. METHODS: This review will be conducted using the JBI methodology for scoping reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Databases and relevant organizational websites will be searched for eligible studies. Title and abstract, and, subsequently, full-text screening will be conducted in duplicate. Data from identified full texts will be extracted using a pre-determined checklist, while the findings will be summarized descriptively and presented in tables. REVIEW REGISTRATION: Open Science Framework https://osf.io/u8yrn.

• MeSH
• Humans MeSH
• Fraud prevention & control   MeSH
• Systematic Reviews as Topic MeSH
• Scientific Misconduct * MeSH
• Research Design standards   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Review MeSH

BACKGROUND AND OBJECTIVE: While prostate cancer (PCa) incidence and mortality rates continue to rise, early detection of PCa remains highly controversial, and the research landscape is rapidly evolving. Existing systematic reviews (SRs) and meta-analyses (MAs) provide valuable insights, but often focus on single aspects of early detection, hindering a comprehensive understanding of the topic. We aim to fill this gap by providing a comprehensive SR of contemporary SRs covering different aspects of early detection of PCa in the European Union (EU) and the UK. METHODS: On June 1, 2023, we searched four databases (Medline ALL via Ovid, Embase, Web of Science, and Cochrane Central Register of Controlled Trials) and Google Scholar. To avoid repetition of previous studies, only SRs (qualitative, quantitative, and/or MAs) were considered eligible. In the data, common themes were identified to present the evidence systematically. KEY FINDINGS AND LIMITATIONS: We identified 1358 citations, resulting in 26 SRs eligible for inclusion. Six themes were identified: (1) invitation: men at general risk should be invited at >50 yr of age, and testing should be discontinued at >70 yr or with <10 yr of life expectancy; (2) decision-making: most health authorities discourage population-based screening and instead recommend a shared decision-making (SDM) approach, but implementation of SDM in clinical practice varies widely; decision aids help men make more informed and value-consistent screening decisions and decrease men's intention to attempt screening, but these do not affect screening uptake; (3) acceptance: facilitators for men considering screening include social prompting by partners and clinician recommendations, while barriers include a lack of knowledge, low-risk perception, and masculinity attributes; (4) screening test and algorithm: prostate-specific antigen-based screening reduces PCa-specific mortality and metastatic disease in men aged 55-69 yr at randomisation if screened at least twice; (5) harms and benefits: these benefits come at the cost of unnecessary biopsies, overdiagnosis, and subsequent overtreatment; and (6) future of screening: risk-adapted screening including (prebiopsy) risk calculators, magnetic resonance imaging, and blood- and urine-based biomarkers could reduce these harms. To enable a comprehensive overview, we focused on SRs. These do not include the most recent prospective studies, which were therefore incorporated in the discussion. CONCLUSIONS AND CLINICAL IMPLICATIONS: By identifying consistent and conflicting evidence, this review highlights the evidence-based foundations that can be built upon, as well as areas requiring further research and improvement to reduce the burden of PCa in the EU and UK. PATIENT SUMMARY: This review of 26 reviews covers various aspects of prostate cancer screening such as invitation, decision-making, screening tests, harms, and benefits. This review provides insights into existing evidence, highlighting the areas of consensus and discrepancies, to guide future research and improve prostate cancer screening strategies in Europe.

• MeSH
• Early Detection of Cancer * MeSH
• European Union * MeSH
• Humans MeSH
• Prostatic Neoplasms * diagnosis   MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Publication type
• Journal Article MeSH
• Review MeSH
• Geographicals
• United Kingdom MeSH

Cohort studies are a robust analytical observational study design that explore the difference in outcomes between two cohorts, differentiated by their exposure status. Despite being observational in nature, they are often included in systematic reviews of effectiveness, particularly when randomized controlled trials are limited or not feasible. Like all studies included in a systematic review, cohort studies must undergo a critical appraisal process to assess the extent to which a study has considered potential bias in its design, conduct, or analysis. Critical appraisal tools facilitate this evaluation. This paper introduces the revised critical appraisal tool for cohort studies, completed by the JBI Effectiveness Methodology Group, who are currently revising the suite of JBI critical appraisal tools for quantitative study designs. The revised tool responds to updates in methodological guidance from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group and reporting guidance from PRISMA 2020, providing a robust framework for evaluating risk of bias in a cohort study. Transparent and rigorous assessment using this tool will assist reviewers in understanding the validity and relevance of the results and conclusions drawn from a systematic review that includes cohort studies. This may contribute to better evidence-based decision-making in health care. This paper discusses the key changes made to the tool, outlines justifications for these changes, and provides practical guidance on how this tool should be interpreted and applied by systematic reviewers.

• MeSH
• Cohort Studies MeSH
• Humans MeSH
• Research Design * standards   MeSH
• Bias * MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH

Current European/US guidelines recommend that molecular testing in advanced non-small cell lung cancer (aNSCLC) be performed using next-generation sequencing (NGS). However, the global uptake of NGS is limited, largely owing to reimbursement constraints. We compared real-world costs of NGS and single-gene testing (SGT) in nonsquamous aNSCLC. This observational study was conducted across 10 pathology centers in 10 different countries worldwide. Biomarker data collected via structured questionnaires (1 January-31 December 2021) were used to feed micro-costing analyses for three scenarios ['Starting Point' (SP; 2021-2022), 'Current Practice' (CP; 2023-2024), and 'Future Horizons' (FH; 2025-2028)] in both a real-world model, comprising all biomarkers tested by each center, and a standardized model, comprising the same sets of biomarkers across centers. Testing costs (including retesting) encompassed personnel costs, consumables, equipment, and overheads. Overall, 4,491 patients with aNSCLC were evaluated. Mean per-patient costs decreased for NGS relative to SGT over time, with real-world model costs 18% lower for NGS than for SGT in the SP scenario, and 26% lower for NGS than for SGT in the CP scenario. Mean per-biomarker costs also decreased over time for NGS relative to SGT. In the standardized model, the tipping point for the minimum number of biomarkers required for NGS to result in cost savings (per patient) was 10 and 12 in the SP and CP scenarios, respectively. Retesting had a negligible impact on cost analyses, and results were robust to variation in cost parameters. This study provides robust real-world global evidence for cost savings with NGS-based panels over SGT to evaluate predictive biomarkers in nonsquamous aNSCLC when the number of biomarkers to be tested exceeds 10. Widespread adoption of NGS may enable more efficient use of limited healthcare resources.

• MeSH
• Cost-Benefit Analysis MeSH
• Genetic Testing economics   methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Biomarkers, Tumor * genetics   MeSH
• Lung Neoplasms * genetics   pathology   diagnosis   MeSH
• Health Care Costs MeSH
• Carcinoma, Non-Small-Cell Lung * genetics   diagnosis   pathology   MeSH
• Aged MeSH
• High-Throughput Nucleotide Sequencing * economics   MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Observational Study MeSH
• Comparative Study MeSH

The increased accessibility of extracorporeal membrane oxygenation following the COVID-19 pandemic and the publication of the first randomized trial of extracorporeal cardiopulmonary resuscitation (ECPR) prompted the National Heart, Lung, and Blood Institute to sponsor a workshop on ECPR. Two more randomized trials have since been published in 2022 and 2023. Based on the combined findings and review of the evidence, an international panel of authors identified gaps in science, inequities in care and diversity in outcomes, and suggested research opportunities and next steps. The science pertaining to ECPR would benefit from the United States contributing uniform data to existing registries and sharing common data with the ELSO (Extracorporeal Life Support Organization) international registry to increase the sample size for observational research. In addition, well-designed efficacy trials, recruiting across different regions of care evaluating long-term follow-up, including patient reported outcomes, cost effectiveness, and equity measures, would contribute significantly to the body of science. Workshop participants defined the population of patients with out-of-hospital cardiac arrest most likely to benefit from ECPR. ECPR-eligible patients include those aged 18 to 75 years functioning independently without comorbidity; before suffering a witnessed out-of-hospital cardiac arrest and without any obvious cause of the cardiac arrest; presenting in a shockable rhythm and transported with mechanical cardiopulmonary resuscitation to an ECPR-capable institute within 30 minutes, which is recommended after 3 rounds of advanced life support treatment without return of spontaneous circulation. There are significant inequities in out-of-hospital cardiac arrest care that need to be addressed such that outcomes are optimized for each target region before implementing ECPR in a clinical or implementation trial.

• MeSH
• COVID-19 epidemiology   therapy   MeSH
• Cardiopulmonary Resuscitation * methods   MeSH
• Consensus MeSH
• Humans MeSH
• Evidence Gaps MeSH
• Extracorporeal Membrane Oxygenation * methods   MeSH
• National Heart, Lung, and Blood Institute (U.S.) * MeSH
• SARS-CoV-2 MeSH
• Out-of-Hospital Cardiac Arrest * therapy   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Review MeSH
• Geographicals
• United States MeSH

IMPORTANCE: Depressive symptoms are associated with cognitive decline in older individuals. Uncertainty about underlying mechanisms hampers diagnostic and therapeutic efforts. This large-scale study aimed to elucidate the association between depressive symptoms and amyloid pathology. OBJECTIVE: To examine the association between depressive symptoms and amyloid pathology and its dependency on age, sex, education, and APOE genotype in older individuals without dementia. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional analyses were performed using data from the Amyloid Biomarker Study data pooling initiative. Data from 49 research, population-based, and memory clinic studies were pooled and harmonized. The Amyloid Biomarker Study has been collecting data since 2012 and data collection is ongoing. At the time of analysis, 95 centers were included in the Amyloid Biomarker Study. The study included 9746 individuals with normal cognition (NC) and 3023 participants with mild cognitive impairment (MCI) aged between 34 and 100 years for whom data on amyloid biomarkers, presence of depressive symptoms, and age were available. Data were analyzed from December 2022 to February 2024. MAIN OUTCOMES AND MEASURES: Amyloid-β1-42 levels in cerebrospinal fluid or amyloid positron emission tomography scans were used to determine presence or absence of amyloid pathology. Presence of depressive symptoms was determined on the basis of validated depression rating scale scores, evidence of a current clinical diagnosis of depression, or self-reported depressive symptoms. RESULTS: In individuals with NC (mean [SD] age, 68.6 [8.9] years; 5664 [58.2%] female; 3002 [34.0%] APOE ε4 carriers; 937 [9.6%] had depressive symptoms; 2648 [27.2%] had amyloid pathology), the presence of depressive symptoms was not associated with amyloid pathology (odds ratio [OR], 1.13; 95% CI, 0.90-1.40; P = .29). In individuals with MCI (mean [SD] age, 70.2 [8.7] years; 1481 [49.0%] female; 1046 [44.8%] APOE ε4 carriers; 824 [27.3%] had depressive symptoms; 1668 [55.8%] had amyloid pathology), the presence of depressive symptoms was associated with a lower likelihood of amyloid pathology (OR, 0.73; 95% CI 0.61-0.89; P = .001). When considering subgroup effects, in individuals with NC, the presence of depressive symptoms was associated with a higher frequency of amyloid pathology in APOE ε4 noncarriers (mean difference, 5.0%; 95% CI 1.0-9.0; P = .02) but not in APOE ε4 carriers. This was not the case in individuals with MCI. CONCLUSIONS AND RELEVANCE: Depressive symptoms were not consistently associated with a higher frequency of amyloid pathology in participants with NC and were associated with a lower likelihood of amyloid pathology in participants with MCI. These findings were not influenced by age, sex, or education level. Mechanisms other than amyloid accumulation may commonly underlie depressive symptoms in late life.

• MeSH
• Amyloid beta-Peptides * cerebrospinal fluid   metabolism   MeSH
• Apolipoprotein E4 genetics   MeSH
• Biomarkers cerebrospinal fluid   MeSH
• Depression * MeSH
• Adult MeSH
• Cognitive Dysfunction * MeSH
• Middle Aged MeSH
• Humans MeSH
• Peptide Fragments cerebrospinal fluid   MeSH
• Positron-Emission Tomography * MeSH
• Cross-Sectional Studies MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Age Factors MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

BACKGROUND: Clozapine is recommended by national and international guidelines for people with treatment-resistant schizophrenia. However, available meta-analyses of randomised controlled trials have not shown superior efficacy of clozapine when compared with other second-generation antipsychotics, with heterogeneity identified between the original studies. We aimed to use individual patient data (IPD) to account for potential reasons of variability and to synthesise an adjusted estimate for the difference in efficacy between clozapine and other second-generation antipsychotics for treatment-resistant schizophrenia. METHODS: In this systematic review and IPD meta-analysis, we searched the Cochrane Schizophrenia Group's Study-Based Register from inception to Jan 24, 2024, and previous reviews for blinded randomised controlled trials comparing clozapine with other second-generation antipsychotics in participants with treatment-resistant schizophrenia. Trials were eligible if they included patients with treatment-resistant schizophrenia and had a duration of at least 6 weeks. IPD were requested from trial investigators. The primary outcome was change in overall schizophrenia symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) between clozapine and other second-generation antipsychotics after 6-8 weeks of treatment. The effect size measure for the primary outcome was mean difference with 95% credible interval (CrI). We fitted a Bayesian random-effects IPD meta-regression model that included duration of illness, baseline severity, and sex as potential prognostic factors or treatment effect modifiers. Confidence in the evidence was assessed using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). People with lived experience of mental illness were involved in this study. This study is registered with PROSPERO, CRD42021254986. FINDINGS: We screened 13 876 references and included 19 studies with data for 1599 participants; IPD were available for 12 of 19 trials (n=1052; mean age 37·67 years [SD 11·24; range 10-66]; 348 [33·08%] women and 704 [66·92%] men). Data on ethnicity were not available. The estimated mean difference in change from baseline PANSS total score was -0·64 points (95% CrI -3·97 to 2·63; τ=2·68) in favour of other second-generation antipsychotics. Shorter duration of illness and higher baseline severity were prognostic factors associated with a larger reduction in symptoms, but neither those factors nor sex were found to modify the relative effect between clozapine and other second-generation antipsychotics. The confidence in the evidence was graded as very low. INTERPRETATION: This IPD meta-analysis found a small and uncertain advantage of other second-generation antipsychotics, mainly olanzapine and risperidone, and so did not provide evidence for superior efficacy of clozapine compared with other second-generation antipsychotics in treatment-resistant schizophrenia. It is limited by unavailability of IPD for some studies, uncaptured sources of variance, and uncertainty due to premature study discontinuation. Given the side-effects of clozapine, the observed uncertainty regarding clozapine's superiority warrants prudent use and further research. FUNDING: German Ministry of Education and Research.

• MeSH
• Antipsychotic Agents * therapeutic use   MeSH
• Adult MeSH
• Clozapine * therapeutic use   MeSH
• Humans MeSH
• Randomized Controlled Trials as Topic MeSH
• Schizophrenia, Treatment-Resistant * drug therapy   MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Meta-Analysis MeSH
• Systematic Review MeSH

The human mind, trying to perceive events coherently, creates the illusion of continuous time passage. Empirical evidence suggests distortions in subjectively perceived time flow associated with well-studied neural responses to sensory stimuli. This study aimed to investigate whether visually uncomfortable patterns, causing exceptionally strong brain activation, affect short time estimates and whether these estimates vary based on the overall reported sensory sensitivity and cortical excitability of individuals. Two experiments in virtual reality testing our assumptions at different levels of complexity of timed stimuli provided initial insight into the studied processes in highly controlled and realistic conditions. Data analysis results did not support our hypotheses, but showed that subjectively most visually uncomfortable simple patterns, i.e., achromatic gratings, cause more variable temporal judgments. Supposedly, this inaccuracy depends on the currently perceived visual comfort and thus the current visual system sensitivity, which cannot be satisfactorily derived from trait-based measures. The exploration of the effect of complex stimuli, i.e., virtual exteriors, suggested that their visual comfort does not affect time perception at all. Biological sex was an important variable across experiments, as males experienced temporal compression of stimuli compared to females. Neuroimaging research is needed for a deeper investigation of the origin of these results.Protocol registration: The Stage 1 manuscript associated with this Registered Report was in-principle accepted on 4 March 2024 prior to data collection for hypothesis testing. The accepted version of the manuscript can be found in the publicly available OSF repository at https://doi.org/ https://doi.org/10.17605/OSF.IO/K3YZE .

• MeSH
• Adult MeSH
• Humans MeSH
• Young Adult MeSH
• Brain physiology   diagnostic imaging   MeSH
• Photic Stimulation methods   MeSH
• Virtual Reality MeSH
• Time Perception * physiology   MeSH
• Visual Perception * physiology   MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Young Adult MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

Idiopathic inflammatory myopathies (IIM), or myositis, are a heterogeneous group of systemic autoimmune disorders that are associated with significant morbidity and mortality. Conducting high-quality clinical trials in IIM is challenging due to the rare and variable presentations of disease. To address this challenge, the Myositis Clinical Trials Consortium (MCTC) was formed. MCTC is a collaborative international alliance dedicated to facilitating, promoting, coordinating and conducting clinical trials and related research in IIM. This partnership works to advance the discovery of effective evidence-based treatments for IIM by integrating a diverse group of clinical investigators, research professionals, medical centres, patient groups, and industry partners. The Steering Committee, Core Group, and Paediatric Subcommittee of MCTC are comprised of myositis experts and junior investigators from around the world, representing a diversity of genders, geographies, and subspecialties. MCTC works alongside other current myositis organisations to complement existing work by concentrating on the operationalisation of clinical trials. Our pilot Myositis Investigators' Information Survey gathered responses from 173 myositis investigators globally and found considerable variability in proficiency with outcome measures, geographic disparities in patient recruitment, and a significant disconnect between investigators' routine myositis patient load and clinical trial enrolment. MCTC will meet the need to support and diversify myositis clinical trials by facilitating trial planning, feasibility assessments, site selection, and the training and mentoring of junior investigators/centres to establish their readiness for clinical trial participation. Through experienced leadership, strategic collaborations, and interdisciplinary discussions, MCTC will establish standards for IIM clinical trial design, protocols, and outcome measures in myositis.

• MeSH
• Child MeSH
• Adult MeSH
• Clinical Trials as Topic * MeSH
• Cooperative Behavior MeSH
• Humans MeSH
• International Cooperation * MeSH
• Adolescent MeSH
• Myositis * therapy   diagnosis   MeSH
• Research Design MeSH
• Check Tag
• Child MeSH
• Adult MeSH
• Humans MeSH
• Adolescent MeSH
• Publication type
• Journal Article MeSH
• Review MeSH

BACKGROUND AND AIMS: The Moral Incongruence Model of Pornography Use proposes that pornography-use-related problems may be present due to problematic pornography use (PPU) and/or moral disapproval (MD) of pornography use. Despite some supporting empirical evidence, no study has tested the presence of different pornography-use profiles based on individuals' behavioral dysregulation (i.e., PPU) and moral values concerning pornography use. The generalizability of previous findings to diverse populations has also been limited given the scarcity of studies conducted outside of Western countries. METHODS: Using data from the International Sex Survey (42 countries, N = 66,994; Mage = 32.16 years, SD = 12.27), we conducted latent profile analysis to identify pornography-use profiles based on individuals' frequency of use, MD, and PPU. The profiles were compared along a wide range of pornography-use-related, sexuality-related, and psychological correlates. RESULTS: Six pornography-use profiles were identified, including two increased risk groups (i.e., Increased risk of PPU without MD and Increased risk of PPU with some MD). Several factors differentiated between the increased risk vs. no/low risk profiles (e.g., relatedness satisfaction) as well as between the two increased risk profiles (e.g., religiosity). Apart from behavioral dysregulation, moral values concerning pornography use played an important role in distinguishing pornography-use profiles and demonstrated the importance of inquiring about MD when working with individuals with pornography-use-related problems. CONCLUSION: Findings also support recent calls for better-integrated sex therapy and sexual medicine perspectives into pornography-use-related problems research and care.

• MeSH
• Adult MeSH
• Erotica * psychology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Morals * MeSH
• Sexual Behavior MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH