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We systematically reviewed observational and Mendelian randomization (MR) articles that evaluated the association between obesity and 17 gastrointestinal (GI) diseases to integrate causal and observational evidence. A total of 594 observational studies from 26 systematic reviews and meta-analyses and nine MR articles were included. For every 5 kg/m2 increase in body mass index (BMI), there was an increased risk of GI diseases ranging from 2% for rectal cancer (relative risk [RR]: 1.02, 95% confidence interval [CI]: 1.01 to 1.03) to 63% for gallbladder disease (RR: 1.63, 95% CI: 1.50 to 1.77). MR articles indicated that risks of developing GI diseases elevated with each 1 standard deviation increase in genetically predicted BMI, ranging from 11% for Crohn's disease to 189% for nonalcoholic fatty liver disease. Moreover, upper GI conditions were less susceptible, whereas hepatobiliary organs were more vulnerable to increased adiposity. Among the associations between obesity and the 17 GI conditions, causal relationships were inferred from only approximately half (10/17, 59%). This study reveals a substantial gap between observational and causal evidence, indicating that a combined approach is necessary to effectively inform public health policies and guide epidemiological research on obesity and GI diseases.

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INTRODUCTION: People with severe mental illness have poor cardiometabolic health. Commonly used antidepressants and antipsychotics frequently lead to weight gain, which may further contribute to adverse cardiovascular outcomes. AREAS COVERED: We searched MEDLINE up to April 2023 for umbrella reviews, (network-)meta-analyses, trials and cohort studies on risk factors, prevention and treatment strategies of weight gain associated with antidepressants/antipsychotics. We developed 10 clinical recommendations. EXPERT OPINION: To prevent, manage, and treat antidepressant/antipsychotic-related weight gain, we recommend i) assessing risk factors for obesity before treatment, ii) monitoring metabolic health at baseline and regularly during follow-up, iii) offering lifestyle interventions including regular exercise and healthy diet based on patient preference to optimize motivation, iv) considering first-line psychotherapy for mild-moderate depression and anxiety disorders, v) choosing medications based on medications' and patient's weight gain risk, vi) choosing medications based on acute vs long-term treatment, vii) using effective, tolerated medications, viii) switching to less weight-inducing antipsychotics/antidepressants where possible, ix) using early weight gain as a predictor of further weight gain to inform the timing of intervention/switch options, and x) considering adding metformin or glucagon-like peptide-1 receptor agonists, or topiramate (second-line due to potential adverse cognitive effects) to antipsychotics, or aripiprazole to clozapine or olanzapine.

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INTRODUCTION: People with substance use disorder (SUD) face challenges like stigma and discrimination, impacting their healthcare experiences. AIM: This study aims to: (i) assess physicians' clinical practices and stigma toward SUD patients among healthcare personnel and (ii) explore the relationship among stigma, psychological well-being, and burnout. METHODS: A survey covering sociodemographic data, physicians' clinical practices, stigmatizing attitudes, psychological well-being, and burnout was completed by 1,796 employees of the Veneto's Local Health Units (Italy). RESULTS: Healthcare professionals reported increased stigma towards SUDs (p-values<0.05). Stigma consistently correlated with variables such as sex, profession, department, and levels of burnout (p-values<0.05). Notably, high burnout levels were associated with increased stigma. Staff in addiction departments displayed lower stigma levels compared to other departments. No significant differences were found in physicians' clinical practices. CONCLUSIONS: Targeted training for healthcare professionals is crucial to reduce stigma, enhance attitudes toward SUDs, and broaden overall knowledge of the condition.

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INTRODUCTION: Given the increasing rates of antipsychotic use in multiple psychiatric conditions, greater attention to the assessment, monitoring and documentation of their side effects is warranted. While a significant degree of attention has been provided to metabolic side effect monitoring, comparatively little is known about how clinicians screen for, document and monitor the motor side effects of antipsychotics (ie, parkinsonism, akathisia, dystonia and dyskinesias, collectively 'extrapyramidal side effects', EPS). This review aims to systematically assess the literature for insights into current trends in EPS monitoring practices within various mental health settings globally. METHODS AND ANALYSIS: An electronic search will be performed using the OVID Medline, PubMed, Embase, CINAHL and APA PsycINFO databases for studies published in the last quarter century (1998 to present day). Two independent reviewers will conduct the initial title and abstract screenings, using predetermined criteria for inclusion and exclusion. A third reviewer will resolve disagreements if consensus cannot be reached. If selected for inclusion, full-text data extraction will then be conducted using a pilot-tested data extraction form. Quality assessment will be conducted for all included studies using a modified version of the Quality Improvement Minimum Quality Criteria Set. A narrative synthesis and summary of the data will be provided. All stages of the review process will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. ETHICS AND DISSEMINATION: Ethical approval is not required. Findings will be peer reviewed, published and shared verbally, electronically and in print with interested clinicians and will also be presented as posters or talks at relevant medical conferences and meetings. PROSPERO REGISTRATION NUMBER: CRD42023482372.

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Weighing risks and benefits of the use of psychotropic medications during pregnancy remains a challenge worldwide. We systematically assessed the strength of associations between psychotropic medication use in pregnant people with mental disorders and various adverse health outcomes in both pregnant people and foetuses. Systematic reviews with meta-analyses of observational studies investigating the association between exposure to psychotropic medication in pregnancy and any adverse health outcomes were included. Credibility was graded into convincing, highly suggestive, suggestive, weak or not significant. Quality of the meta-analyses and of individual studies were assessed with A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2) the Newcastle-Ottawa Scale (NOS), respectively. We considered 21 meta-analyses encompassing 17,290,755 participants (AMSTAR 2 high = 1, low = 12, or critically low = 8). Evidence was suggestive for: (1) preterm birth in pregnant people with either any mental disorder (equivalent odds ratio 1.62 (95% confidence interval 1.24-2.12) or depression (1.65 [1.34-2.02]) receiving antidepressants during any trimester of pregnancy; (2) small for gestational age for pregnant people with depression receiving a SSRI during any trimester of pregnancy (1.50 [1.19-1.90]); and (3) major congenital malformation (1.24 [1.09-1.40]) or cardiac malformations (1.28 [1.11-1.47]) in babies for pregnant people with depression or anxiety receiving paroxetine during first trimester of pregnancy. Additional associations were supported by weak evidence, or were not statistically significant. This umbrella review found no convincing or highly suggestive level of evidence of adverse health outcomes associated with psychotropic medication use in pregnant people with mental disorders.

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To further explore the role of different antipsychotic treatments for cardio-cerebrovascular mortality, we performed several subgroup, sensitivity and meta-regression analyses based on a large previous meta-analysis focusing on cohort studies assessing mortality relative risk (RR) for cardio-cerebrovascular disorders in people with schizophrenia, comparing antipsychotic treatment versus no antipsychotic. Quality assessment through the Newcastle-Ottawa Scale (NOS) and publication bias was measured. We meta-analyzed 53 different studies (schizophrenia patients: n = 2,513,359; controls: n = 360,504,484) to highlight the differential effects of antipsychotic treatment regimens on cardio-cerebrovascular-related mortality in incident and prevalent samples of patients with schizophrenia. We found first generation antipsychotics (FGA) to be associated with higher mortality in incident samples of schizophrenia (oral FGA [RR=2.20, 95 %CI=1.29-3.77, k = 1] and any FGA [RR=1.70, 95 %CI=1.20-2.41, k = 1]). Conversely, second generation antipsychotics (SGAs) and clozapine were associated with reduced cardio-cerebrovascular-related mortality, in prevalent samples of schizophrenia. Subgroup analyses with NOS score ≥7 (higher quality) demonstrated a significantly increased cardio-cerebrovascular disorder-related mortality, among those exposed to FGAs vs SGAs. Meta-regression analyses demonstrated a larger association between antipsychotics and decreased risk of mortality with longer follow-up, recent study year, and higher number of adjustment variables. Overall, this subanalysis of a systematic review contributes to the evolving understanding of the complex role of antipsychotic treatment for cardio-cerebrovascular mortality in schizophrenia, paving the way for more targeted interventions and improved patient outcomes.

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BACKGROUND: Electrolytes (sodium, potassium, calcium, magnesium, chloride, phosphate) are required in specific amounts for proper functioning of the human body. Although the body has different organ systems, such as the kidneys, that regulate electrolyte levels in the blood, electrolyte abnormalities occur frequently in people with eating disorders. The objective of this review will be to examine the association between electrolyte imbalances and adverse outcomes in people with eating disorders. METHODS: A systematic review of studies on eating and electrolyte disorders shall be conducted. Electronic searches shall be done in the Ovid MEDLINE, EMBASE, and PsycINFO databases. Selected studies shall include randomized control trials (RCTs), non-randomized controlled trials, and cross-sectional studies published in English or French. Quality appraisal of studies and a narrative synthesis of extracted data shall be conducted. DISCUSSION: This review will synthesize existing evidence on electrolyte abnormalities in people with eating disorders. It will identify the type of electrolyte imbalances, their impact, and outcomes in people with eating disorders. We anticipate that information that will be useful to policy makers and clinicians in designing better policies to prevent eating disorders and or manage people with eating disorders shall be elucidated in this study. DISSEMINATION: The final manuscript will be submitted for publication in a journal. REVIEW REGISTRATION: This protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO); registration number CRD42023477497.

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OBJECTIVE: Suicide is a major global public health concern. While some progress has been made in understanding risk factors for suicidal behavior, other relevant questions have received less attention. One such question relates to the longitudinal course of suicidal behavior amongst individuals with multiple suicide attempts. This systematic review investigated whether there is an increase in the lethality across multiple suicide attempts. METHOD: This systematic review followed PRISMA 2020 reporting guidelines. A literature search was conducted in MEDLINE, Embase and PsycINFO electronic databases from inception to August 2023 to identify studies with key terms related to multiple suicide attempts and lethality. The review included longitudinal studies with data on multiple suicide attempts, and any rating of their lethality. Covidence was used to guide the screening and extraction process. A narrative synthesis approach was used to descriptively summarize included studies. RESULTS: After identifying 828 unique abstracts for screening, 11 studies were included for narrative synthesis. Suicide attempt assessment methods and definitions were heterogenous, often indirectly inferring lethality based on suicide attempt method. Individuals with repeat attempts may be more likely to continue using the same method. CONCLUSIONS: There was no evidence to support increasing lethality across repeat suicide attempts. However, this should be interpreted along with the fact that the evidence base is scarce, heterogenous, and methodologically limited.

There was no strong evidence for an increasing pattern of lethality across repeat attempts.A higher proportion of individuals continue to use the same method across repeat attempts.The evidence base is scarce, heterogenous, and methodologically limited.

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Introduction: Eating Disorders (EDs) affect individuals globally and are associated with significant physical and mental health challenges. However, access to adequate treatment is often hindered by societal stigma, limited awareness, and resource constraints. Methods: The project aims to utilize the power of Artificial Intelligence (AI), particularly Machine Learning (ML) and Deep Learning (DL), to improve EDs diagnosis and treatment. The Master Data Plan (MDP) will collect and analyze data from diverse sources, utilize AI algorithms for risk factor identificat io n, treatment planning, and relapse prediction, and provide a patient-facing chatbot for information and support. This platform will integrate patient data, support healthcare professionals, and empower patients, thereby enhancing care accessibility, personalizing treatment plans, and optimizing care pathways. Robust data governance measures will ensure ethical and secure data management. Results: Anticipated outcomes include enhanced care accessibility and efficiency, personalized treatment plans leading to improved patient outcomes, reduced waiting lists, heightened patient engagement, and increased awareness of EDs with improved resource allocation. Discussion: This project signifies a pivotal shift towards data-driven, patient-centered ED care in Italy. By integrat ing AI and promoting collaboration, it seeks to redefine mental healthcare standards and foster better well- being among individuals with EDs.

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Psychedelics are a group of psychoactive substances which produce complex and subjective changes to consciousness and carry unique safety considerations. There is a growing body of work investigating the use of psychedelics for mental health treatment alongside increasing socio-cultural and political acceptance. This rapid evolution has prompted corporations to fund psychedelic clinical trials, leading to a potential rise in conflicts of interest in relevant studies and publications. However, the body of evidence for the safety and efficacy of psychedelic-assisted psychotherapy for psychiatric illnesses is early. There is concern regarding the introduction of bias in psychedelic clinical trials and the selective reporting of results amidst and beyond corporate involvement. At a crucial time in psychedelic drug reform, this paper explores the safety concerns associated with psychedelics, the potential influences of financial stakeholders on safety outcome reporting and the importance of balanced science communication in maintaining public health and safety.

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Aims: To map studies assessing both clinical high risk for psychosis (CHR-P) and borderline personality disorder (BPD) in clinical samples, focusing on clinical/research/preventive paradigms and proposing informed research recommendations. Methods: We conducted a PRISMA-ScR/JBI-compliant scoping review (protocol: https://osf.io/8mz7a) of primary research studies (cross-sectional/longitudinal designs) using valid measures/criteria to assess CHR-P and BPD (threshold/subthreshold) in clinical samples, reporting on CHR-P/psychotic symptoms and personality disorder(s) in the title/abstract/keywords, identified in Web of Science/PubMed/(EBSCO)PsycINFO until 23/08/2023. Results: 33 studies were included and categorized into four themes reflecting their respective clinical/research/preventive paradigm: (i) BPD as a comorbidity in CHR-P youth (k = 20), emphasizing early detection and intervention in psychosis; (ii) attenuated psychosis syndrome (APS) as a comorbidity among BPD inpatients (k = 2), with a focus on hospitalized adolescents/young adults admitted for non-psychotic mental disorders; (iii) mixed samples (k = 7), including descriptions of early intervention services and referral pathways; (iv) transdiagnostic approaches (k = 4) highlighting "clinical high at risk mental state" (CHARMS) criteria to identify a pluripotent risk state for severe mental disorders. Conclusion: The scoping review reveals diverse approaches to clinical care for CHR-P and BPD, with no unified treatment strategies. Recommendations for future research should focus on: (i) exploring referral pathways across early intervention clinics to promote timely intervention; (ii) enhancing early detection strategies in innovative settings such as emergency departments; (iii) improving mental health literacy to facilitate help-seeking behaviors; (iv) analysing comorbid disorders as complex systems to better understand and target early psychopathology; (v) investigating prospective risk for BPD; (vi) developing transdiagnostic interventions; (vii) engaging youth with lived experience of comorbidity to gain insight on their subjective experience; (viii) understanding caregiver burden to craft family-focused interventions; (ix) expanding research in underrepresented regions such as Africa and Asia, and; (x) evaluating the cost-effectiveness of early interventions to determine scalability across different countries. Systematic Review Registration: https://osf.io/8mz7a.

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Importance: The COVID-19 pandemic placed many physicians in situations of increased stress and challenging resource allocation decisions. Insight into the prevalence of posttraumatic stress disorder in physicians and its risk factors during the COVID-19 pandemic will guide interventions to prevent its development. Objective: To determine the prevalence of posttraumatic stress disorder (PTSD) among physicians during the COVID-19 pandemic and examine variations based on factors, such as sex, age, medical specialty, and career stage. Data Sources: A Preferred Reporting Items for Systematic Reviews and Meta-analyses-compliant systematic review was conducted, searching MEDLINE, Embase, and PsychInfo, from December 2019 to November 2022. Search terms included MeSH (medical subject heading) terms and keywords associated with physicians as the population and PTSD. Study Selection: Peer-reviewed published studies reporting on PTSD as a probable diagnosis via validated questionnaires or clinician diagnosis were included. The studies were reviewed by 6 reviewers. Data Extraction and Synthesis: A random-effects meta-analysis was used to pool estimates of PTSD prevalence and calculate odds ratios (ORs) for relevant physician characteristics. Main Outcomes and Measures: The primary outcome of interest was the prevalence of PTSD in physicians, identified by standardized questionnaires. Results: Fifty-seven studies with a total of 28 965 participants and 25 countries were included (of those that reported sex: 5917 of 11 239 [52.6%] were male and 5322 of 11 239 [47.4%] were female; of those that reported career stage: 4148 of 11 186 [37.1%] were medical trainees and 7038 of 11 186 [62.9%] were attending physicians). The estimated pooled prevalence of PTSD was 18.3% (95% CI, 15.2%-22.8%; I2 = 97%). Fourteen studies (22.8%) reported sex, and it was found that female physicians were more likely to develop PTSD (OR, 1.93; 95% CI, 1.56-2.39). Of the 10 studies (17.5%) reporting age, younger physicians reported less PTSD. Among the 13 studies (22.8%) reporting specialty, PTSD was most common among emergency department doctors. Among the 16 studies (28.1%) reporting career stage, trainees were more prone to developing PTSD than attendings (OR, 1.33; 95% CI, 1.12-1.57). Conclusions and Relevance: In this meta-analysis examining PTSD during COVID-19, 18.3% of physicians reported symptoms consistent with PTSD, with a higher risk in female physicians, older physiciansy, and trainees, and with variation by specialty. Targeted interventions to support physician well-being during traumatic events like pandemics are required.

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Sub-optimal response in schizophrenia is frequent, warranting augmentation strategies over treatment-as-usual (TAU). We assessed nutraceuticals/phytoceutical augmentation strategies via network meta-analysis. Randomized controlled trials in schizophrenia/schizoaffective disorder were identified via the following databases: PubMed, MEDLINE, EMBASE, Scopus, PsycINFO, CENTRAL, and ClinicalTrials.gov. Change (Standardized Mean Difference = SMD) in total symptomatology and acceptability (Risk Ratio = RR) were co-primary outcomes. Secondary outcomes were positive, negative, cognitive, and depressive symptom changes, general psychopathology, tolerability, and response rates. We conducted subset analyses by disease phase and sensitivity analyses by risk of bias and assessed global/local inconsistency, publication bias, risk of bias, and confidence in the evidence. The systematic review included 49 records documenting 50 studies (n = 2384) documenting 22 interventions. Citicoline (SMD =-1.05,95%CI = -1.85; -0.24), L-lysine (SMD = -1.04,95%CI = -1.84; -0.25), N-acetylcysteine (SMD = -0.87, 95%CI = -1.27; -0.47) and sarcosine (SMD = -0.5,95%CI = -0.87-0.13) outperformed placebo for total symptomatology. High heterogeneity (tau2 = 0.10, I2 = 55.9%) and global inconsistency (Q = 40.79, df = 18, p = 0.002) emerged without publication bias (Egger's test, p = 0.42). Sarcosine improved negative symptoms (SMD = -0.65, 95%CI = -1.10; -0.19). N-acetylcysteine improved negative symptoms (SMD = -0.90, 95%CI = -1.42; -0.39)/general psychopathology (SMD = -0.76, 95%CI = -1.39; -0.13). No compound improved total symptomatology within acute phase studies (k = 7, n = 422). Sarcosine (SMD = -1.26,95%CI = -1.91; -0.60), citicoline (SMD = -1.05,95%CI = -1.65;-0.44), and N-acetylcysteine (SMD = -0.55,95%CI = -0.92,-0.19) outperformed placebo augmentation in clinically stable participants. Sensitivity analyses removing high-risk-of-bias studies confirmed overall findings in all phases and clinically stable samples. In contrast, the acute phase analysis restricted to low risk-of-bias studies showed a superior effect vs. placebo for N-acetylcysteine (SMD = -1.10, 95%CI = -1.75,-0.45), L-lysine (SMD = -1.05,95%CI = -1.55, -0.19), omega-3 fatty acids (SMD = -0.83,95%CI = -1.31, -0.34) and withania somnifera (SMD = -0.71,95%CI = -1.21,-0.22). Citicoline (SMD = -1.05,95%CI = -1.86,-0.23), L-lysine (SMD = -1.04,95%CI = -1.84,-0.24), N-acetylcysteine (SMD = -0.89,95%CI = -1.35,-0.43) and sarcosine (SMD = -0.61,95%CI = -1.02,-0.21) outperformed placebo augmentation of TAU ("any phase"). Drop-out due to any cause or adverse events did not differ between nutraceutical/phytoceutical vs. placebo+TAU. Sarcosine, citicoline, and N-acetylcysteine are promising augmentation interventions in stable patients with schizophrenia, yet the quality of evidence is low to very low. Further high-quality trials in acute phases/specific outcomes/difficult-to-treat schizophrenia are warranted.

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BACKGROUND: We aimed to systematically review meta-analyses on the link between attention-deficit/hyperactivity disorder (ADHD) and a broad range of psychiatric, physical, and behavioral health conditions (PROSPERO; no.CRD42023448907). RESULTS: We identified 22 meta-analyses that included 544 primary studies, covering 76 unique conditions in over 234 million participants across 36 countries and six continents. We found high-certainty evidence for the associations between ADHD and neuropsychiatric conditions (bipolar disorders, personality disorders, schizophrenia, and pragmatic language skills), night awakenings, obesity, decayed incipient surfaces, asthma, astigmatism, hyperopia and hypermetropia, strabismus, and suicide ideation. Moderate-certainty evidence suggested that ADHD was associated with headache, mood/affective disorders, depression, bruxism, bone fractures, atopic rhinitis, vision problems, suicide attempts, completed suicide, and all-cause mortality. Low-certainty evidence indicated associations with eating disorders, sleep efficiency, type 2 diabetes, dental trauma prevalence, atopic diseases, and atopic dermatitis. Very low-certainty evidence showed associations between ADHD and several sleep parameters. CONCLUSION: We found varied levels of evidence for the associations of ADHD with multiple health conditions. Therefore, clinicians should consider a wide range of neurological, psychiatric, sleep and suicide-related, metabolic, musculoskeletal, oral, allergic, and visual conditions, as well as the increased risk of mortality when assessing individuals with ADHD.

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BACKGROUND: The association between depression and dementia is still unclear, particularly regarding depression as a potential risk factor preceding dementia. Therefore, we aimed to verify if the presence of depression at baseline may increase the risk of dementia and cognitive impairment during 15 years of follow-up in the SHARE (Survey of Health, Aging and Retirement in Europe) study. METHODS: Depressive symptoms were defined using the EURO-D, with a score ≥4 indicative of depression. Incident dementia was ascertained using self-reported data and caregivers' information, cognitive impairment using objective cognitive tests. Cox regression analysis, adjusted for 10 baseline confounders, was run and hazard ratios (HRs), with their 95% confidence intervals, were estimated. RESULTS: In total 22,789 participants were included in the present analysis (mean age 64.2 years) and were predominantly female. The prevalence of depression at baseline was 24.9%. Over 15 years of follow-up, the onset of dementia occurred a median 2 years earlier in people with depression compared to those without. Depression at the baseline significantly increased the risk of dementia in the overall sample (HR = 1.74; 95% CI: 1.54-1.95) and the risk of cognitive impairment (HR = 1.15; 95% CI: 1.06-1.25). For dementia, the association was stronger in people less than 60 years (HR = 2.07; 95% CI: 1.42-3.02) than in participants aged ≥80 years (HR = 1.47; 95% CI: 1.14-1.91). A similar trend was observed for cognitive impairment. Among the single items of the EURO-D, loss of concentration was the strongest individual variable predicting the onset of dementia. CONCLUSIONS: Depression increased the risk of dementia and cognitive impairment, particularly in younger adults, whereas loss of concentration was the strongest individual predicting variable of dementia. These findings demonstrate the need for early detection of depression for preventing future cognitive worsening.

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Systematic reviews are a cornerstone for synthesizing the available evidence on a given topic. They simultaneously allow for gaps in the literature to be identified and provide direction for future research. However, due to the ever-increasing volume and complexity of the available literature, traditional methods for conducting systematic reviews are less efficient and more time-consuming. Numerous artificial intelligence (AI) tools are being released with the potential to optimize efficiency in academic writing and assist with various stages of the systematic review process including developing and refining search strategies, screening titles and abstracts for inclusion or exclusion criteria, extracting essential data from studies and summarizing findings. Therefore, in this article we provide an overview of the currently available tools and how they can be incorporated into the systematic review process to improve efficiency and quality of research synthesis. We emphasize that authors must report all AI tools that have been used at each stage to ensure replicability as part of reporting in methods.

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Meta-research, also known as "research on research" is a field of study that investigates the methods, reporting, reproducibility, evaluation, and incentives along the research continuum. Meta-research literacy is imperative to ensure high quality, transparent and reproducible primary data or meta-research products. In this commentary, we propose that early career researchers should be trained in meta-research as a foundation to develop a deeper understanding of the research process and ability to appraise the research literature and design high-quality original studies, irrespective of their chosen field of study. We discuss the importance of meta-research and open science from the perspective of an early career trainee, highlighting essential areas for growth and obstacles one may encounter.

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BACKGROUND AND HYPOTHESIS: Substance use is highly prevalent among people with schizophrenia (SCZ) and related disorders, however, there is no broad-spectrum pharmacotherapy that concurrently addresses both addiction and psychotic symptoms. Psychosocial (PS) interventions, which have yielded promising results in treating psychosis and substance dependence separately, demonstrate potential but have not been systematically evaluated when combined. STUDY DESIGN: Systematic review and random-effects meta-analyses of randomized controlled trials (RCTs) investigating PS interventions for individuals with comorbid substance use and psychotic disorders, encompassing SCZ and schizophrenia spectrum disorders (SSD). We included relevant studies published from MEDLINE, PsycINFO, and Google Scholar through May 2023. STUDY RESULTS: We included 35 RCTs (5176 participants total; approximately 2840 with SSD). Intervention durations ranged from 30 min to 3 years. Meta-analysis did not identify a statistically significant pooled PS intervention effect on the main primary outcome, substance use (18 studies; 803 intervention, 733 control participants; standardized mean difference, -0.05 standard deviation [SD]; 95% CI, -0.16, 0.07 SD; I2 = 18%). PS intervention effects on other outcomes were also not statistically significant. Overall GRADE certainty of evidence was low. CONCLUSIONS: At present, the literature lacks sufficient evidence supporting the use of PS interventions as opposed to alternative therapeutic approaches for significantly improving substance use, symptomatology, or functioning in people with SCZ and related disorders. However, firm conclusions were precluded by low certainty of evidence. Further RCTs are needed to determine the efficacy of PS treatments for people with dual-diagnoses (DD), either alone or in combination with pharmacotherapy.

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INTRODUCTION: Observational studies are fraught with several biases including reverse causation and residual confounding. Overview of reviews of observational studies (ie, umbrella reviews) synthesise systematic reviews with or without meta-analyses of cross-sectional, case-control and cohort studies, and may also aid in the grading of the credibility of reported associations. The number of published umbrella reviews has been increasing. Recently, a reporting guideline for overviews of reviews of healthcare interventions (Preferred Reporting Items for Overviews of Reviews (PRIOR)) was published, but the field lacks reporting guidelines for umbrella reviews of observational studies. Our aim is to develop a reporting guideline for umbrella reviews on cross-sectional, case-control and cohort studies assessing epidemiological associations. METHODS AND ANALYSIS: We will adhere to established guidance and prepare a PRIOR extension for systematic reviews of cross-sectional, case-control and cohort studies testing epidemiological associations between an exposure and an outcome, namely Preferred Reporting Items for Umbrella Reviews of Cross-sectional, Case-control and Cohort studies (PRIUR-CCC). Step 1 will be the project launch to identify stakeholders. Step 2 will be a literature review of available guidance to conduct umbrella reviews. Step 3 will be an online Delphi study sampling 100 participants among authors and editors of umbrella reviews. Step 4 will encompass the finalisation of PRIUR-CCC statement, including a checklist, a flow diagram, explanation and elaboration document. Deliverables will be (i) identifying stakeholders to involve according to relevant expertise and end-user groups, with an equity, diversity and inclusion lens; (ii) completing a narrative review of methodological guidance on how to conduct umbrella reviews, a narrative review of methodology and reporting in published umbrella reviews and preparing an initial PRIUR-CCC checklist for Delphi study round 1; (iii) preparing a PRIUR-CCC checklist with guidance after Delphi study; (iv) publishing and disseminating PRIUR-CCC statement. ETHICS AND DISSEMINATION: PRIUR-CCC has been approved by The Ottawa Health Science Network Research Ethics Board and has obtained consent (20220639-01H). Participants to step 3 will give informed consent. PRIUR-CCC steps will be published in a peer-reviewed journal and will guide reporting of umbrella reviews on epidemiological associations.

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